CN103582463B - Apparatus and method for tissue treatment - Google Patents

Apparatus and method for tissue treatment Download PDF

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Publication number
CN103582463B
CN103582463B CN201280014567.3A CN201280014567A CN103582463B CN 103582463 B CN103582463 B CN 103582463B CN 201280014567 A CN201280014567 A CN 201280014567A CN 103582463 B CN103582463 B CN 103582463B
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tissue
energy
processing
target tissue
treatment
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CN103582463A (en
Inventor
哈里斯·拉贾戈帕兰
杰伊·卡普兰
J·克里斯托弗·弗莱厄蒂
菲利普·S·莱文
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Fraktale Health Co
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Fractyl Laboratories Inc
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Abstract

Disclose system, the method and apparatus for handling tissue.System includes the elongated tubular with distal portion.Treatment element is positioned in elongate tube distal portion, and the treatment element is fabricated and is arranged as handling target tissue.In one embodiment, gastrointestinal tissue is changed for the treatment of diabetes.

Description

Apparatus and method for tissue treatment
The cross reference of related application
This application claims this application claims the entitled " method for being used to treat diabetes submitted on January 19th, 2011 And system " first U.S. Provisional Application 61/434,319（Lawyer's Reference Number：41714-703.101）, entire contents are incorporated to this Text is as reference；The application also requires entitled " being used for the apparatus and method for handling tissue " submitted for 23rd in September in 2011 First U.S. Provisional Application 61/538,601（Lawyer's Reference Number：41714-703.102）, entire contents are incorporated herein as joining Examine.
Technical field
Embodiments disclosed herein is related generally to handle tissue, the particularly system of gastrointestinal tissue, dress Put and method.There is disclosed herein the method for treating diabetes.
Background technology
Diabetes are a kind of metabolic diseases, wherein the body of individual can not generate the thin of enough insulin or the body Born of the same parents can not effectively respond generated insulin, so as to which the individual forms hyperglycaemia.Diabetes are broadly divided into two kinds：1 type With 2 types.Type 1 diabetes are due to that body can not produce enough insulin and cause, and diabetes B is then derived from body pancreas The autoimmune destruction of island β cells, so as to which body can not produce enough insulin, and diabetes B is a complexity Metabolic disorder, due to insulin resistance（The cell of wherein body fails properly insulin caused by utilization）Given birth to insulin Production is insufficient for the needs of body and causes hyperglycaemia.
It presently, there are some methods for being intended to treat diabetes based on above concept.These methods need major operation, remove If the stem portion in GI roads, and/or long-term graft.As any major operation, gastric bypass surgery has the risk of complication.
The device for delivering energy to body is developed.For example, cardiac ablation devices have been designed to hat Shape arterial tissue provides energy.In addition, urethrectomy device has been designed to burning or cutaway portion prostate.These technologies It is respectively modified, the specific part and disease specific to be treated for being suitable for being more efficiently used for pending body.
It is required to by applying energy to intestines and stomach to provide the system and method for the therapeutic treatment of intestines and stomach.Specifically For, it is desirable to provide a kind of diabetes remedy, its operation in the gastrointestinal tract is smaller than the wound of gastric bypass surgery, and to suffering from Person has the further advantage that.
The content of the invention
The system of present inventive concept, the target tissue of method and apparatus processing patient, are such as provided for the disease or illness of patient Treatment.System for treating diabetes mellitus includes observation assembly, selection component and processing component.The observation assembly allows Assess duodenal mucosa.It is described to select the target region that component selects patient's duodenal mucosa to be handled.The processing Component handles the duodenal mucosa processing region of patient so that the processing causes the duodenum of patient relative to the stomach of patient Anatomically remained intact with jejunum.The processing region include with least one in patient's jejunal mucous membrane and gastric mucosa Region adjacent duodenal mucosa region.
The processing component is adapted to remove the duodenal mucosa of the patient, and the processing may include to disappear Except the stem cell in duodenum.
The processing component goes for melting the tissue in the duodenal mucosa.
The processing component is adapted to the tissue melted in duodenal mucosa and may include sacculus, and the sacculus is matched somebody with somebody It is ready for use on the ablation sub-component of ablation duodenal mucosa.
The processing component is adapted to remove the duodenal mucosa of the patient, and may include to be used for shaving And/or at least one of razor and/or scraper of duodenal mucosa described in scraping.The razor and/or scraper may include A kind of sacculus, the sacculus is equipped with the cutter device for handling the duodenal mucosa.
The system can further comprise tissue distention device, such as build and arrange for expanding under duodenal mucous membrane The tissue distention device of tissue.
According to another aspect of the present invention, elongated tubular and treatment element are included for treating the system of patient.It is described thin Long tube is usually flexible axle, and it includes distal portion, and the treatment element is placed in elongate tube distal portion.The processing elements Part is fabricated and arranged for handling target tissue and avoiding the adverse effect to non-target tissue.Provide a method that, wherein The system is provided, and target tissue is handled with the treatment element.
The selection of target tissue and target tissue processing is applied to many patient disease or illness, includes but is not limited to：Glycosuria Disease；Type 1 diabetes；Diabetes B；Hypercholesterolemia；Metabolic syndrome disease；Chylous diarrhea；It is fat；Cancer such as broncho-pulmonary Steep cancer；And cystitis.In certain embodiments, not using long-term implant（Such as it is not left within body and exceedes The implant of 24 hours）.In other embodiments, the device being chronically implanted into can include such as in the following group Device：Support；Sleeve；And drug delivery device such as the support coated, the sleeve and/or implantable pump of coating；And these Combination.
The treatment element is arranged to target the tissue of one or more positions of patient.The target tissue includes three The tissue of volume is tieed up, and may include that Part I, its processing have the process part for the treatment of benifit to patient；And second Divide, its processing has minimum or safe enough and to spare part of being free from side effects to the patient.Non-target tissue can be accredited as it by institute State the tissue that the caused infringement for the treatment of element or other side effects are reduced or avoided.
Target tissue processing may include one or more effects to target tissue, the effect in being such as selected from the group：What is changed is thin Born of the same parents' function；Cell death；Apoptosis；Instant cell death；Meronecrosis；Cell degeneration；The removal of cell；And combinations thereof. Target tissue can be selected so that target tissue and/or tissue and the place of the processing of the target tissue are substituted after processing Target tissue before reason has different functions.The processing of the target tissue can trigger inflammatory reaction.The processing of the target tissue can Cause target tissue cell to become nonfunctional and/or prevent cell from secreting.The processing of the target tissue can change cell autocrine and/ Or paracrine signal.The change and/or replace tissue and can have different secretion or secretory volume from the target tissue of before processing, To treat diabetes or obesity.The change and/or replace tissue can have different absorptions from the target tissue of before processing Characteristic, to treat diabetes；Fat and/or hypercholesterolemia.The new tissue may include different cholesterol absorptions Energy.The effect of the processing can sharp occur, such as within 24 hours, or in longer time as being higher than 24 Individual hour or the time generation afterwards higher than one week.
The pending target tissue may include two or more tissue parts, such as with first group of the first processing processing Knit part and/or the first treatment element, and the minor microstructure part handled with second processing and/or second processing element.Institute Stating the first and second tissue parts can be overlapping, and they can be adjacent, such as include two kinds of adjacent part-circular peripheries （partial circumferential）Tissue part.First and second processing and/or treatment element can be similar Or dissimilar.Dissmilarity may include to treat the type and/or amount of the energy delivered by energy delivery treatment element.Other not phases It seemingly may include but be not limited to the target tissue region of processing；The target tissue depth of processing；The target tissue circumferential section of processing；Energy is passed Send type；And energy delivery rates and/or amount.The system can be fabricated and arrange for being sequentially processed the first target group Knit part and the second target tissue part.The first and second target tissues part may include that similar or dissimilar tissue is special Sign.Similar or dissimilar tissue signature can be in the following group：Organization type such as organizes channel type；Tissue density；Group Knit thickness；And these combination.The first target tissue part can be similar with the processing to minor microstructure part or not Similar mode is handled.Dissmilarity between the first processing and second processing can be in the following group：Energy level；Pass Send the duration；Tissue temperature and these combination during delivering.The first tissue part can compare minor microstructure Part is thinner, and the system can be arranged at the temperature lower than minor microstructure part, than minor microstructure portion Divide under low energy level, and/or the first tissue part is handled with the processing duration shorter than minor microstructure part.
Target tissue may include Duodenal Tissues, such as include all duodenal mucosa layers or part thereof of tissue, with Just treat diabetes or obesity makes duodenum be anatomically connection simultaneously.Replace tissue may include in following one Item or the cell of multinomial migration：Gastric mucosa；Jejunal mucous membrane；Or duodenal undressed part, its mucosal tissue function It is different from the function of the mucosal tissue of the processing before treatment.In certain embodiments, target tissue includes processing tissue And safe enough and to spare tissue, the processing tissue includes duodenal mucosa layer, and the safe enough and to spare tissue is including described The complete or partial layer of duodenal submucosa.In certain embodiments, target tissue includes the institute of complete length Duodenal mucosa layer is stated, and may include a part of and the neighbouring pylorus of the duodenal mucosa and/or a part and institute State the neighbouring jejunum of duodenal mucosa.The processing of Duodenal Tissues can be carried out with treat disease in the following group or Illness：Diabetes；It is fat；Insulin resistance；Metabolic disorder and/or disease；And these combination.Generally to the mucous layer Complete circumferential section（Such as 360 °）Handled.In certain embodiments, the target tissue is included along duodenum At least one section innermost mucous membrane part layer at least circumferential section.In these embodiments, the target tissue can wrap Include the tissue part in the following group：Along the part layer of the innermost mucous membrane of at least circumferential section of duodenum total length； The complete circumferential section of the part layer of the innermost mucous membrane；Along the part layer of the innermost mucous membrane of duodenum total length Complete circumferential section；The stem cell of Crypt base；Pass by amplifying cells；And these combination.Target tissue may include edge The part layer of the innermost mucous membrane of the complete circumferential section of duodenum total length.Target tissue may include described at least a portion Duodenal submucosa.In these embodiments, the target tissue may include the tissue part in the following group：Edge The part layer of the innermost submucosa at least circumferential section that duodenum at least one saves；Along duodenum total length at least The part layer of the innermost submucosa of circumferential section；The complete circumferential part of the part layer of the innermost submucosa Point；Along the complete circumferential section of the part layer of the innermost submucosa of duodenum total length；And these combination.Institute Stating target tissue may include the part of duodenal one or more longitudinal directions.The target tissue may include the distal portion of stomach, such as certainly The distal portion of stomach is crossed over to the target tissue of the close end of jejunum.The target tissue may include to cross over to ligament of Treitz from pylorus Tissue.The target tissue may include duodenal part-circular periphery portion, such as close to ampulla hepatopancreatica（Ampulla of Vater） Duodenal part-circular periphery portion and/or close to pancreas duodenal part-circular periphery portion.The target tissue may include one The tissue of depthkeeping degree, as certain predefines the tissue of depth.The tissue depth may include complete mucous layer and/or complete Submucosa.The target tissue depth may include portion of tissue layer, the part submucosa depth such as in the following group：Completely Submucosa centesimal depth；25 the percent of complete submucosa depth；Complete submucosa is deep 50 the percent of degree；And these combination.The target tissue may include depth, length and width, and the target group The depth knitted can be relatively uniform along length and/or width.Or the target tissue may include depth, length and width Degree, and the depth of the target tissue can change along length and/or width.Patient anatomy and/or physiology can be based on Situation selects target tissue, anatomy and/or physiological situation such as in the following group：Hyperglycaemia hypertonicity state；Diabetes Property ketoacidosis；Insulin resistance；Prediabetes；Hypertriglyceridemia；And these combination.The target can be based on Total anatomy of tissue and/or functional boundary selection target tissue, total anatomy of such as position in the following group And/or functional boundary：Tissue between duodenum and adjacent stomach intestinal tissue；In duodenal four parts Between tissue；And these combination.
Target tissue may include the tissue of the terminal ileum, to treat hypercholesterolemia or diabetes.Target tissue Extend to proximal ileum and/or colon.
Target tissue may include mucosa tissue, such as produce hungry element（ghrelin）And/or the area of other Appetite regulation hormones Domain, to treat fat or appetite disorder.
Target tissue may include the bladder wall tissue, to treat the disease or illness in the following group：Interstitial cystitis； Carcinoma of urinary bladder；Polyp of bladder；The precancerous lesion of bladder；And these combination.
Target tissue may include the tissue in the following group：Big and/or flat polyp of colon；Stayed after polypectomy The edge tissues deposited；And these combination.These tissue locations can be processed to treat the cancer cell of residual.
Target tissue may include air flue lining tissue, to treat the disease or illness in the following group：Bronchovesicular Cancer；Other lung cancer；Tuberculosis becomes before cancer；And these combination.
Target tissue may include at least a portion enteron aisle with IBD, so as to treat Crohn's disease or burst Ulcer colitis.
Target tissue may include the tissue in oral cavity, one or more in the precancerous lesion of carcinoma of mouth and oral cavity to treat.
Target tissue may include the tissue of nasopharynx, to treat nasal polyp.
Target tissue may include chosen gastrointestinal tissue to treat chylous diarrhea and/or improve intestinal barrier function.
The treatment element, systems, devices and methods can be fabricated and arrange for avoiding handling some be referred to herein as The tissue of " non-target tissue ".Depending on the position of processing, applicable different non-target tissue.In certain embodiments, non-target Tissue may include the tissue in the following group：The outermost of serous coat, tunica muscularis and/or the submucosa such as during mucous membrane processing The part layer in face；Such as close to ampulla hepatopancreatica（Ampulla of Vater）Mucous membrane processing during ampulla hepatopancreatica；It is difficult to understand Di's sphincter；Pancreas；Bile duct；Pylorus；Biological organs；And these combination.
The treatment element of present inventive concept may include transducer or other function element for being arranged to deliver energy, The element being selected from the following group：Sound delivery element, such as PZT (piezoelectric transducer) and ultrasonic crystal；Electromagnetic energy delivery elements such as electricity Pole；Laser transmissibility element, such as optical fiber, prism, lens and other optical modules；Cutting element, such as scraper plate（blade）, it is thick Rough surface or abrasion screen cloth；And combinations thereof.The treatment element of present inventive concept can be can advance and/or regracting , and can be being radially expanded, can radially extending and/or can radial compaction.The element that can be radially expanded can wrap Include sacculus, cage and can be in the arm of radial development one or more, such as there is the sacculus of grinding element or surface or contain It is configured to deliver the sacculus of one or more electrodes of electromagnetic energy.Treatment element may include three or more energy deliveries member Part, as three or more are configured at the energy delivery elements in the arrangement that can be radially expanded.Treatment element can be with radial dilatation State processing tissue, such as be used for compression organization（Such as during energy delivery）；Prevent hemoperfusion；And/or for making place Reason element such as energy delivery electrode is in contact with tissue.Treatment element can configure to meet the Local Anatomy of target tissue, such as The inflatable cage that treatment element includes the suitable sacculus of Local Anatomy and/or Local Anatomy is adapted to.The treatment element can To be configured to perform complete circumference tissue treatment in one step, or in multi-step at executable portion circumference tissue Reason.Treatment element may be configured to expand as at least 2 centimetres of at least 1 centimetre of diameter or diameter.Treatment element can be fabricated And arrange for causing the blood close to target tissue to migrate off target tissue, to avoid undesired heat sink effect.
It can include second processing element in the system of present inventive concept, device and method, such as be arranged on first First treatment element of elongated tubular and installed in being slidably received by first elongated tubular（slidingly received）The second processing element of second elongated tubular.It is different that first and second treatment element may be configured to delivering Tissue treatment, such as the energy with the first form first handle and the second processing with various forms of energy.The Two treatment elements are generally mounted to the distal portion of first extending shaft or the second elongated tubular.
Sacculus is configurable to treatment element, as containing between 43 DEG C and 100 DEG C, generally between 65 DEG C and 90 DEG C For the sacculus for the fluid for handling the target tissue.Sacculus may include one or more electrodes, as one or more is configured to With unipolar fashion（Such as energy is passed through between balloon electrode and piece or other skin electrodes）Deliver electromagnetic energy（Such as radio frequency Energy）And/or in a bipolar fashion（Such as energy is passed through between two balloon electrodes）Segmentation to tissue delivery electromagnetic energy or Flexible electrode.Multiple sacculus can be included, the sacculus of tissue abrading apparatus is such as configured to and is configured to the sacculus of interstitial ablation. In some more sacculus embodiments, the first sacculus is with hot fluid ablation and/or electromagnetic energy ablation processing tissue, and second Sacculus is configured to denude tissue.Second sacculus can be placed on distal end or the near-end of the first sacculus.Treatment element may include more Leaf formula sacculus, such as it is configured to hot fluid and delivers the multi-blade type sacculus of energy and/or in one or more to target tissue Include the multi-blade type sacculus of one or more energy delivery electrodes on leaf.Fluid such as air, carbon dioxide and/or salt solution can be used Make the sacculus expansion for being configured to treatment element.
The treatment element of present inventive concept can be arranged to deliver energy, such as be the company delivered by energy delivery elements Continuous, pulse and/or variable energy.In one configuration, the first energy apply be after delivering be similar or not similar The second energy for targetting identical or different target tissue is applied.Energy delivery can be change, be change in single administration Or it is change to be applied first between the second administration, to adapt to different target tissue thickness, such as duodenal mucosa Or the different-thickness of duodenal submucosa.In some embodiments, electromagnetic energy is passed in first applies and second applies Send.First administration can be delivered to the first layer of tissue, and the second administration has higher energy level than the first administration, is passed Deliver to the deeper second layer of tissue.Energy delivery can be change, be to change or applied first in single administration With being change between the second administration, to avoid the undesired processing to non-target tissue.The energy delivery of change can wrap Include the change of transmitted energy level.Pulse energy delivering may include the transmission of pulsewidth modulation energy and/or time division multiplexing Energy transmits.
The energy of delivering can be one or more forms, the energy in being such as selected from the group：Electromagnetic energy, such as radio frequency and microwave Energy；Plasma energy, such as it is used for the argon plasma energy of blood coagulation；Acoustic energy, such as ultrasonic energy and infrasound energy；Luminous energy, such as swash Luminous energy, infrared energy and visible luminous energy；Chemical energy；Heat energy such as hot and cold energy；Mechanical energy, such as cut by one or more and/or ground Lose the mechanical energy of device delivery；And these combination.The energy of delivering can be the electromagnetic energy in being selected from the group：Unionized Energy；Ionization energy；Non-plasma forms energy；Plasma forming energy；And combinations thereof.Electromagnetic energy can be delivered with Remove tissue, ablation tissue, shrinkage tissue, modified tissue and/or hemostasis is provided.The system may include saline delivery assembly, It is fabricated and arranged so that salting liquid is delivered into neighbouring target tissue during energy delivery.The energy of transmission can be laser Can, the laser energy in being such as selected from the group：
CO2 laser, KTP laser, Er:YSGG laser, Er:Glass；Ho:YAG laser；Ho:YSGG laser；nd:YAG swashs Light；Nd:YSGG；Nd:The laser of doping；Semiconductor laser；Excimer laser；Chlorination xenon laser；Argon fluoride lasers；And it Combination.Laser energy can be delivered by the laser in being selected from the group：Rear-earth-doped crystal laser；Argon gas or Krypton Body laser；Liquid laser, such as dye laser, and combinations thereof.The chemical energy of delivering can be delivered to target group The chemical strippers knitted, the activating agent in being such as selected from the group：Acid, phenol/crotons；And combinations thereof.Activating agent can pass through choosing From the outlet port delivering in the following group：Nozzle；Opening；Film；And combinations thereof.The activating agent of delivering can be arranged to By the energy absorption of one or more forms, such as it is arranged to support light power and/or the transmissible chromophore of ultrasound.Quilt The activating agent of delivering may include dyestuff.Heat energy can be delivered to handle target tissue, it is such as conformal such as by the hot fluid filled in sacculus Sacculus（conformal balloon）.Hot fluid can be the fluid in being selected from the group：Water, salt solution, glycerine, steam and it Combination.Can by heating and/or can heating component transferring heat energy, it is described can heating component be, for example, cage, cutter, wire rod And combinations thereof.Heat energy can apply in the first energy delivery and the second energy delivery, such as when the first energy delivery be Carried out at the temperature higher than the second energy delivery.Heat energy can be delivered by magnetic-particle, and the magnetic-particle is such as by MRI field The particle of heating and/or the particle for being arranged to conjunctive tissue such as Duodenal Tissues.Cold energy can be delivered to handle target tissue, Such as when the cold temperature source during the system includes being selected from the group：CO2；Argon gas；Nitrous oxide；Liquid nitrogen and combinations thereof.Can example Mechanical energy is such as delivered to by tissue by abrasion device, the abrasion device includes the one or more in the following group：Around Sacculus with abrasion screen cloth；Sacculus with embedded abrasive material；And it is configured to remove the abrasion device of tissue. Abrasion device can be configured as such as by the power assembly of system rotationally and/or translationally.It can be handled by fluid ejector Target tissue, such as it is fabricated and arranges the fluid ejector for delivering the fluid in being selected from the group：Water, air, CO2, steam with And combinations thereof.Water ejector can be arranged to remove target tissue and/or cause target tissue to become to function, such as The cell secretion reduce, organized or change target tissue.Two or more can be delivered by one or more energy delivery elements Various forms of energy.Two or more various forms of energy can be delivered simultaneously and/or sequentially.It can use and target tissue The treatment element of contact delivers energy, such as when treatment element is configured to the sacculus equipped with hot liquid or penetrates including one or more The assembly of frequency electrode.Alternatively or additionally, it can use and liquid is included between target tissue or the gap of air is separated Treatment element deliver energy, being configured as laser delivery elements or high strength supersonic transmissibility is first when the treatment element During part.Energy delivery pipeline such as wire rod or optical fiber can be arranged to transfer energy to treatment element.It may include gel to change Kind energy is such as placed on the gel on treatment element or near it to the transfer organized.Gel may include in being selected from the group Gel：Conductivity of heat gel；Conductive gel；Translucency gel and combinations thereof.The treatment element can be fabricated and cloth Put for delivering energy to target tissue by ultrasonic delivery and/or electro-ionic osmosis.
Energy delivery or other specification can be measured using sensor, are used for as being fabricated and arranging including one or more The sensor of the sensor of signal is provided.In some embodiments, sensor is used for by closed loop energy delivery come treatment group Knit, the sensor of certain signal is such as provided, the signal represents：The amount of the energy of delivering；The cumulant of the energy of delivering；Energy The depth penetrated；The depth of resulting processing；Tissue temperature；Organize physical characteristic such as color；And combinations thereof.It is described Sensor may include to build and arrange for adjusting the transmissible temperature sensor of energy delivery such as radio frequency and/or impedance sensing Device.The sensor may include configuration to provide the sensor about tissue thickness's information, such as imaging sensor, as ultrasonic wave passes Sensor, OCT sensor and/or OCDR sensors.The sensor may include configuration to provide the sensor of energy delivery information, Such as the depth information of energy delivery.The sensor can be installed on elongated tubular and/or treatment element, such as expandable processing Element.The sensor can be placed for contacting tissue wall such as Duodenal Tissues wall.The sensor can be placed for Infiltration resides in the layer of organized layer such as submucosa tissue on the contrary, such as during submucosal injections, for measuring One or more of temperature, flow velocity and pressure.Such as when system is constructed and arranged with the myoelectricity based on the muscular layer of mucosa During figure delivering energy, the system can include myoelectric sensor.The system may include calorimetric sensors and/or serum levels Sensor.Such as when system is constructed and arranged the change for quantifying tissue color such as chorionic villi, the system can be with Including imaging sensor.
The elongated tubular of present inventive concept can be inserted into body cavity body cavity, the body part in being such as selected from the group：Stomach and intestine Road, oesophagus, stomach, pylorus, duodenum, jejunum, lung, bladder, pharynx nasalis, bladder, colon, air flue, oral cavity, and their group Close.Elongated tubular, which may be further configured for being inserted into body, enters device, enter such as endoscope, laparoscopic port, through stomach device, Blood vessel guide, such as by before being loaded in or behind being loaded in.Elongated tubular can be rotated, and can have one or more Part such as distal portions are deflected, and are such as connected to the controller on near-end handle by bracing wire, pluggable flexual center axle is such as By be configured as from room temperature be changed into body temperature when changes shape the flexual center axle that builds of shape-memory material, and/or other are inclined Turn assembly.Deflection assembly can be configured to result in or improve contact of the target tissue with treatment element.It may include multiple Elongated tubular, such as the first elongated tubular includes first processing units, and the second elongated tubular includes second processing element.Second elongated tubular by First elongated tubular is slidably received, or it may be placed in beside the first elongated tubular.
It may include one or more expandable elements in the system of the present invention, be such as installed on the expandable member of elongated tubular Part.The expandable element can be used for expanding and contacting with tissue, circumferentially to contact body cavity（Such as one of intestines and stomach Point）Inwall.Expandable element may include expandable sacculus or cage, and one or more treatment elements can include institute State inflatable element and/or be installed in the inflatable element.Inflatable element can be pressurized, to be applied to tissue Add the power of change.The variable force of application can be used for changing the processing to tissue, as changed electrode or hot fluid sacculus with tissue Contact, so as to change the impedance of the amount of the processing of tissue, the depth, strength disposal, electrode of processing, and these combination.
It may include the sensor of one or more diversified forms and type in the systems, devices and methods of present inventive concept. Sensor is mountable to elongated tubular, treatment element and/or the element that can be radially expanded.Sensor may include but be not limited to：Heat passes Sensor, such as thermocouple；Impedance transducer, such as tissue impedance's sensor；Pressure sensor；Blood sensor；Optical sensor, example Such as optical sensor；Sound transducer, such as ultrasonic sensor；Electromagnetic sensor, such as emf sensor；And these group Close.Processing can be monitored based on the one or more signals received from one or more sensors.Sensor can be placed on Tissue as among target tissue, on or it is neighbouring.Sensor can provide the parameter information of patient, the information in being such as selected from the group： The temperature of temperature information such as tissue temperature information or treatment element；The impedance information of impedance information, such as tissue；Pressure information；Blood Stream information；Blood sugar level；Insulin level；Plasma Glucagon Level；GIP, GLP-1, GLP-2 and/or other gastrointestinal hormones It is horizontal；And these combination.The sensor can include imaging sensor, such as provide the information on tissue color change Imaging sensor.Imaging sensor can be arranged to produce the image in being selected from the group：Tissue thickness schemes；Tissue blood vessel Figure；The ice hockey figure found in cryogenic energy delivering；And their combination.Imaging sensor may be selected from：X ray such as fluorescope into Picture；CT is imaged；MRI；Ultrasonic imaging；Molecular imaging；Nuclear imaging, if any or without sugar tolerance test nuclear imaging；OCT, spectrum is such as Tera-hertz spectra（Tera-Hertz spectroscopy）；And these combination.
It may include multiple function element more than one in the system of present inventive concept, method and apparatus.Function element can be by On elongated tubular, the function element in being such as selected from the group：Sensor, transducer, vacuum ports, visualization element or device Such as ultrasonic crystal or optics assembly；And combinations thereof.Vacuum ports can be arranged to remove tissue and/or make At least a portion of system contacts with tissue, to make elongated tubular and/or treatment element be contacted with tissue.System functions can With including visualization device, the visualization device in being such as selected from the group：Visible Light Camera；Ultrasonic imaging device；Optical coherence tomography Imager；And combinations thereof.
It may include that body cavity is pressurized assembly, to deliver pressure fluid.Pressure fluid can be transmitted by inner chamber, such as endoscope Or the inner chamber of elongated tubular.The pressurization assembly can include source of pressurised fluid, the air blowing liquid such as comprising liquid and/or gas, such as It is configurable for the liquid and/or gas for expanding the inner chamber of body cavity such as intestines and stomach.It may include one or more occlusive members Part, the sacculus being such as arranged on elongated tubular, to limit the migration of pressure fluid（Such as the pressure in holding inner chamber such as duodenum Power）.Blow gas pressure may remain in H2O of the pressure more than 0.5 centimetre but the H2O less than 15 centimetres.The system may include by with Put to deliver the second elongated tubular of pressure fluid.Second elongated tubular can be fabricated and arrange for entering device slidably by body Ground accommodates, and is such as fabricated and arranges the endoscope for slidably receiving the first elongated tubular and the second elongated tubular.
It may include that body enters device, be such as arranged to receive the endoscope for the elongated tubular for including treatment element.It can wrap Imaging device, such as the visualization device of insertion body are included, is such as integrated into or inserts the Visible Light Camera of endoscope, ultrasonic imaging Instrument, and/or OCT imager.Alternately or in addition, it may include external visualization device, such as：X ray；Fluoroscopic image； Ultrasonic imaging；MRI；PET scanner；And combinations thereof.
It may include energy delivery unit, be such as arranged to deliver the unit of the energy of one or more forms.Energy can Including closed loop energy delivery, the closed-loop delivery such as based on tissue temperature or tissue impedance.It may include controller and user interface, with Just one or more system input parameters are inputted or check one or more system output parameters.System input parameter can include But it is not limited to：The type of energy to be delivered such as radio frequency energy, heat energy and/or mechanical energy；The amount of energy with delivering, it is such as to be delivered Energy accumulation joule number, or the peak value of energy to be delivered；The type and level of energy combination to be delivered；The energy delivers Duration；The pulse width modulation percentage of the energy delivered；The reciprocating motion number that abrasion device crosses；Treatment element Temperature, such as target temperature or maximum temperature；Blow gas pressure；Blow the duration；And these combination.System input parameter can To include but is not limited to the preoperative or peri-operation period parameter in being selected from the group：Mucous membrane density and/or thickness；Glued after submucosal injections The mucous membrane " lifting " of film lower floor（lift off）；The lengthwise position of intestines and stomach inner target tissue；And combinations thereof.System exports Parameter may include but be not limited to：Temperature information such as tissue and/or the temperature information for the treatment of element；Pressure information, such as balloon pressure Information or blow gas pressure information；Dynamics information, as applied to the information that structural dynamics is horizontal；Patient information, such as pass through one The physiologic information of the patient of individual or multiple sensor records；And these combination.User can be fabricated and arrange with start, Mitigate and/or stop the processing that treatment element is delivered, such as handled by the energy delivery for the treatment of element delivering.
It may include motion transmission assembly, with rotationally and/or translationally elongated tubular and/or one or more treatment elements. In some embodiments, tissue abrading apparatus is during tissue treatment by rotation and translation.In some embodiments, at tissue Luminous energy delivery elements such as laser or ultrasonic transmissibility element are by rotationally and/or translationally during reason.Motion transmission assembly can be with It is motor driving or operator's manual actuation by system, and can be arranged to rotate and/or put down simultaneously Move one or more treatment elements.Assembly is transmitted in motion can move one or more energy delivery elements in reciprocating motion.
It may include protection cap to protect non-target tissue by harmful effect, not to be placed in ampulla hepatopancreatica such as and/or Oddi includes about Among flesh, on or neighbouring protection cap.Protection cap can be fabricated and be arranged to remove in twenty four hours in patient is inserted Go.
It may include tissue bulking device, be such as arranged to tissue such as duodenal submucosa delivering expansion fluid Tissue bulking device.Tissue bulking device may include water ejector or be arranged to introduce fluid into tissue to be expanded Extensible pin.
It may include tissue effector, the tissue effector being radially expanded as included the element in being selected from the group： Inflatable sacculus；Expandable cage；Extendable arms such as can radial development arm；And combinations thereof.Tissue effector May include for example expandable sacculus of two or more expandable elements or cage, its is expanded to contact tissue, and axially before Enter or retreat with to tissue applying power.The tissue effector can realize the function in being selected from the group：Axially alignment, such as 12 The alignment of duodenum 12 or other intestinal tissues；Tensioning, such as axially and/or radially it is tensioned；Thickness swelling, such as pass through the fluid of injection（Example Such as the liquid or gas of injection）Expand the submucosa of intestines；Apply axial force to tissue；Apply opposite axial direction to tissue Power；Apply radial load to tissue；Compression organization, such as compress Duodenal villi；Induce local edema or angioedema；Make ten Two duodenum 12 are radially expanded to reduce the projection of valvulae conniventes, and prevent or reduce pleat caused by items fold Pleat processing is insufficient；And combinations thereof.In some embodiments, two elements that can be radially expanded are installed to two Individual single elongated tubular, the elongated tubular are configured as independently progressing and retreated.Second elongated tubular can be slided by the first elongated tubular Accommodate dynamicly.Alternatively, the first elongated tubular and the second elongated tubular can be configured abreast.In some embodiments, the tissue Manipulation device includes blowning installation.The tissue effector can include one or more tissue penetration elements.
Activating agent in may include activating agent such as pharmaceutically active agents or being selected from the group：Antibiotic, steroids, mucomembranous cell are protected Protect agent such as ulcerlmin, proton pump inhibitor or other sour blocking drugs and combinations thereof.The activating agent can be specific The region of anatomy or be systematically conveyed to patient.
It may include that program completes algorithm, the algorithm such as based on the time or based on activity, it is arranged at target tissue Prompting is provided when reason is completed or when the processing of a part of target tissue has been sufficiently treated.The algorithm can be based on being selected from down Parameter in group：The duration having already passed through；The energy level of realization；The power level of realization；The energy level reached, such as RF energy The predetermined joule number of amount；The Machine cycle having been carried out such as one group of reciprocating quantity；The tissue having occurred and that becomes Change, color change, texture variations or other visible changes such as having occurred and that；The change of tissue impedance and/or tissue impedance is Through reaching threshold value；The change that temperature and/or temperature change such as temperature and/or tissue temperature has reached threshold value；CBF and/or The change of CBF has reached threshold value；The change of hormone serum level and/or hormone serum level has reached threshold value；Blood The change of sugar level and/or blood sugar level has reached threshold value；Such as when passing through visual inspection or chemistry and/or biological detection Mechanism detects that connective tissue is exposed under mucous membrane；And these combination.
According to another aspect of the present invention, include for treating the method for patient：There is provided includes the system for the treatment of element, And treat target tissue with the therapeutic element.The system also includes the elongated tubular with distal portion, and the processing elements Part is placed in the distal portion of elongated tubular.Disease in being selected from the group of general therapeutic patient：Diabetes；Type 1 diabetes；2 types sugar Urine disease；Hypercholesterolemia；Metabolic syndrome；Disease；Chylous diarrhea；It is fat；Cancer such as bronchovesicular cancer；Cystitis；And Combinations thereof.The system may include one or more embodiments alone or in combination being listed above.In some realities Apply in scheme, implement tissue bulking step, such as when target tissue includes mucosal tissue, inject a fluid into space under mucous membrane.
Methods described can further comprise being implanted into long-term implant, the implant in being such as selected from the group：Support；Sleeve；With And drug delivery device such as the support coated, the sleeve and/or implantable pump of coating；And combinations thereof.
Methods described may include to handle tissue, so as to instead of the neoblastic function and before processing of processed target tissue Target tissue it is different.The type for changing the secretion that can include mucosal tissue from before processing functionally and/or secretion The change of amount, to treat diabetes and/or obesity.Change functionally can include the absorption different from the tissue of before processing Characteristic.
Methods described may include to handle target tissue, and the target tissue includes duodenal mucosa, so as to handled by substituting The mucosal tissue of mucous membrane is different from the function of the mucosal tissue of before processing.Substituting mucomembranous cell can be from gastric mucosa and jejunal mucous membrane One or more migrations.The function different from the mucomembranous cell of before processing can be shown by substituting mucomembranous cell.
Methods described may include to handle tissue, so as to substitute the new tissue of handled target tissue with the target with before processing Organize different absorption characteristics.The change of absorption characteristic can be achieved to treat one or more diseases or illness of patient, wrap Include but be not limited to hypercholesterolemia, such as when processed target tissue includes terminal ileum tissue and/or when replacement tissue table When revealing the cholesterol absorption performances different from the tissue of before processing.
Methods described can avoid damage to and/or otherwise negatively affect non-target tissue, non-in being such as selected from the group Target tissue：Intestines serous；Ampulla hepatopancreatica；Pancreatic tissue；Myenteron；The outmost part layer of intestinal submucosa；Bile duct tissue； Pylorus；The tissue of organ；Oddi's sphincter；And combinations thereof.
Methods described can handle the target tissue including Part I and Part II.The processing of Part I can be with second The processing divided is simultaneously or sequentially carried out.The first tissue part can be overlapping with the tissue of minor microstructure part.The first tissue part can It is adjacent with the minor microstructure part.The first tissue part and minor microstructure part may include adjacent part-circular periphery group Knit part.
Methods described may include the first tissue processing and the minor microstructure similar or dissimilar to the first tissue processing processing. Tissue treatment difference may include but be not limited to：Handled target tissue area；Handled target tissue depth；Handled target group Knit circumferential section；Energy delivery type；Energy delivery rate and/or amount；And combinations thereof.
The processing of target tissue may include that the histocyte in being selected from the group is modified：Cell death；Apoptosis；Instantaneity is thin Born of the same parents are dead；Meronecrosis；Cell degeneration；The removal of cell；And combinations thereof.The treatment of target tissue may include in the following group It is one or more：Remove target tissue cell；Trigger inflammatory reaction；And combinations thereof.Under the treatment of target tissue can include One or more in group：Make target tissue cell nonfunctional；Change the cell secretion of target tissue cell, to prevent cell from secreting； And change the autocrine and/or paracrine signal of target tissue cell.
The processing of target tissue can cause the cell of target tissue to be substituted, such as by with for example different thin of different cell functions The cell replacement of intracrine.
The processing of target tissue can cause change drastically, such as occur handling in 24 hours.Alternatively or Additionally, the processing of target tissue can occur over an extended period of time, be such as longer than the period of 24 hours or be longer than one The period in week.
Methods described can further comprise selecting pending target tissue.The selection can be selected from the group based on to be treated In disease or illness：Diabetes, including 1 type and diabetes B；Hypercholesterolemia；Metabolic syndrome and/or disease；Breast Gruel is rushed down；It is fat；Cancer such as bronchovesicular cancer；Cystitis；And combinations thereof.The selection of target tissue can be based on patient anatomical Or physiological situation：Anatomy or physiological status in being such as selected from the group：Hyperglycaemia hypertonicity state；Diabetic keratopathy ketone acid Poisoning；Insulin resistance；Prediabetes；Hypertriglyceridemia；And combinations thereof.Can be based on the target tissue Total anatomy and/or functional boundary selection target tissue.In some embodiments, target tissue is based on duodenum and phase Feature boundary between adjacent stomach intestinal tissue.In some embodiments, target tissue is to be based on duodenal four portions / feature boundary.
Target tissue may include that its processing causes the processing tissue of the therapeutic effect of expectation.Target tissue can further comprise safety Enough and to spare tissue, it includes the tissue neighbouring with processing tissue, wherein the safe enough and to spare tissue is handled by the tissue Minimum influence, such as when handle tissue include mucosal tissue when the part layer including submucosa safe enough and to spare tissue.
In some embodiments, target tissue includes at least a portion duodenum, and typically at least one of 12 The mucous layer of duodenum 12.The target tissue may include along the innermost mucous membrane of at least one section duodenal at least circumferential section Part layer；Target tissue as included the tissue in being selected from the group：Along duodenum total length at least circumferential section it is innermost The part layer of mucous membrane；The complete circumferential section of the part layer of the innermost mucous membrane；Along the bosom of duodenum total length Mucous membrane part layer complete circumferential section；The stem cell of Crypt base；Pass by amplifying cells；And these combination. Target tissue may include the complete circumferential section along at least one section duodenal mucous layer, and it is generally across duodenal big Part or total length.In addition to duodenal mucosa, target tissue may include at least a portion submucosa, such as along at least one section 12 At least circumferential section of the innermost submucosa part layer of duodenum 12.Target tissue may include the group in being selected from the group under mucous membrane Knit：Along the part layer of the innermost submucosa of at least circumferential section of duodenum total length；Under the innermost mucous membrane The complete circumferential section of the part layer of layer；Along the complete circle of the part layer of the innermost submucosa of duodenum total length Circumferential portion；And these combination.Target tissue may include duodenal one or more longitudinal components, and may include 12 The total length of duodenum 12.Target tissue may include the distal portion of stomach.Target tissue may include the pylorus part adjacent with duodenum.Target tissue It may span across the tissue between the distal portion of stomach and the close end of jejunum.Target tissue may include the group across pylorus to ligament of Treitz Knit.Target tissue may include at least one of jejunum.Target tissue may include the duodenum of complete circumferential part.Target tissue can wrap Duodenal part-circular periphery part is included, such as the circumferential section close to ampulla hepatopancreatica and/or the part of pancreas.12 can be carried out The processing of duodenum 12 tissue is to treat the disease or illness in being selected from the group：Diabetes；It is fat；Insulin resistance；Metabolic disorder and/ Or disease；And combinations thereof.Generally processing includes the target tissue of Duodenal Tissues, and duodenum is existed after treatment It is anatomically connection.
Target tissue may include the depth for including for example complete mucous layer of complete organized layer and/or complete submucosa. Target tissue may include the depth for including portion of tissue layer, and such as part submucosa, it includes complete submucosa depth extremely Few 1 percent, at least 25 the percent of complete submucosa depth, or at least the hundred of complete submucosa depth / five ten.Target tissue may include depth, length and width, and the depth can be in most length and width It is relatively uniform.Or the target tissue may include depth, length and width, and the depth can along length and/ Or width changes.Change in depth target tissue processing can be carried out in multiple processing steps, such as include different energy levels and/ Or multiple steps of processing duration.
In some embodiments, target tissue includes extending to proximal ileum and/or at least a portion end of colon is returned Intestinal tissue, to treat hypercholesterolemia and/or diabetes.
In some embodiments, target tissue includes at least one of gastric mucosa, such as when target tissue includes producing famine When starving plain and/or other Appetite regulation hormones tissues and/or when carrying out target tissue processing to treat appetite disorder.
In some embodiments, target tissue includes the bladder wall tissue, such as carries out target tissue treatment and is selected from the group with treating In disease or illness when：Interstitial cystitis；Carcinoma of urinary bladder；Polyp of bladder；The precancerous lesion of bladder；And these group Close.
In some embodiments, target tissue includes the tissue in being selected from the group：Big and/or flat polyp of colon；Breath The edge tissues retained after meat resection；And these combination, it is such as example residual to treat cancer cell when carrying out target tissue processing During the cancer cell stayed.
In some embodiments, target tissue includes air flue lining tissue, and such as target cell is handled and is selected from treating During with disease or illness in the following group：Bronchovesicular cancer；Other lung cancer；Tuberculosis becomes before cancer；And these combination.
In some embodiments, target tissue includes at least a portion enteron aisle with IBD, such as to target cell When being handled to treat the one or more in Crohn's disease and ulcerative colitis.
In some embodiments, target tissue includes the tissue in oral cavity, such as target tissue is handled to treat carcinoma of mouth During with one or more in the precancerous lesion in oral cavity.
In some embodiments, target tissue includes the tissue of nasopharynx, such as target tissue is handled to treat nasal polyp When.
In some embodiments, target tissue includes being selected to a part for treatment chylous diarrhea or manifold intestines and stomach Tissue.
In some embodiments, target tissue includes being selected to a part for improvement intestinal barrier function or manifold stomach Intestinal tissue.
Methods described can further comprise making the treatment element advance, retreat and/or rotate.
Methods described can further comprise the treatment element for being radially expanded and/or radially extending.The treatment element can wrap Include and/or the element in being selected from the group on：Sacculus, cage, it is at least one can radial development arm and combinations thereof. Target tissue can be handled when the treatment element is in the state being radially expanded.The treatment element can be configured to use In being radially expanded as at least 1 centimetre of diameter, or at least 2 centimetres.Being radially expanded for treatment element can be arranged to cause blood Migrate off the tissue close to treatment element.Being radially expanded for treatment element can be arranged to reduce the group close to treatment element Hemoperfusion in knitting.Being radially expanded for treatment element can be arranged to compress target tissue, such as deliver energy to target tissue During when being compressed to target tissue.
The treatment element can include extensible cage.It is extensible that the cage can include first with the first installation electrode Arm, and at least there is the second extendable arm of the second installation electrode.The cage can be expanded to cause circle target tissue to handle （Such as melt）Without repositioning the cage.Or the cage can be repositioned repeatedly to carry out circle tissue treatment.
Treatment element can include balloon-expandable.The sacculus can be filled with the fluid that temperature improves, such as to transmit Heat energy is to the target tissue.In one embodiment, the temperature of the fluid can be at 65 DEG C to 90 DEG C.In another implementation In scheme, the temperature of the fluid is more than 43 DEG C, generally below 100 DEG C.The sacculus can be filled with one or more The fluid being selected from the group：Air；CO2；Salt solution；And combinations thereof.The sacculus may include one or more electrodes, thus can be by electricity Magnetic energy such as radio frequency energy is delivered to target tissue from one or more of electrodes.One or more of electrodes may include flexible electrical Pole.Multiple segmented electrodes can be mounted to the sacculus.The treatment element can be more blastomere capsules（multiple lobed balloon）, such as more blastomere capsules filled with the elevated fluid of temperature and/or be configured to deliver electromagnetism comprising at least one More blastomere capsules of the electrode of energy.The treatment element can include the second sacculus, such as when the treatment element is included filled with heat When the first sacculus of fluid and the second sacculus, second sacculus be configured to when second sacculus is reversed and/or rotated with Denude tissue.In some embodiments, methods described includes radially oppressing the treatment element, such as sacculus, cage and/or footpath Oppressed to the radial direction that can oppress arm.
Methods described may include the surface texture (topography) for making the treatment element fitting target tissue, such as work as institute Stating treatment element includes suitable type sacculus and/or suitable type cage.
Methods described may include with second processing element processing tissue, such as the second processing installed in elongate tube distal portion Element.Or second processing element can be arranged on the second elongated tubular distal portion, such as by the first elongated tubular slideably received within The second elongated tubular.Methods described may include to promote and/or recall first treatment element and/or second processing element.Institute The method of stating may include to handle target tissue, example with second processing element with the configuration different from the processing implemented by the first treatment element Such as different energy delivery forms.
The processing of target tissue may include energy being delivered to target tissue from treatment element.The energy delivery may include continuously Can even it deliver.The energy delivery may include that pulse energy delivers, such as be delivered using pulse width modulation and/or time division multiplexing Energy.The energy delivery may include the energy delivery of change, be selected from the delivering of the change of the following group：The change of delivered energy The form of change；The level of the change of delivered energy；The energy changed in the application of single energy delivery；Passed in first time energy Send the energy changed between second of energy delivery；And combinations thereof.The system may include optical fiber (optical Fiber) and methods described may include by the Fiber optic delivery energy.The system may include to be configured to improve energy The gel of the transmission to tissue is measured, is selected from the gel of the following group：Thermally conductive gel；Signa Gel；Printing opacity gel；And combinations thereof.
Target tissue processing may include the first energy delivery being delivered to the Part I of target tissue and by the second energy Amount is delivered to the Part II of target tissue.First energy delivery and the second energy delivery may include identical or difference Form of energy.First energy delivery can be delivered with first group of energy delivery parameters, and second energy delivery can Delivered with second group of different energy delivery parameters.Two groups of energy delivery parameters can be based on the first target tissue part and the Difference selection between two target tissue parts, such as the close degree of target tissue thickness and/or target tissue and non-target tissue fermentation Difference.
The target tissue processing may include to deliver energy in the form of being selected from the group：Electromagnetic energy such as radio frequency and microwave energy； Plasma can for example be used for the argon plasma physical efficiency condensed；For example ultrasonic energy of acoustic energy；Luminous energy, such as laser energy, it is infrared can and can See luminous energy；Chemical energy；Heat energy, such as heat or cold energy；Mechanical energy, such as the machine that one or more are cut and/or abrasive element is delivered Tool energy；And combinations thereof.The energy can be delivered using phonophoresis and/or iontophoresis.The energy can handled Delivered when element contacts with target tissue.Or the energy can have gap (example between the treatment element and target tissue Such as non-tissue, the gap such as comprising gas and/or liquid) when deliver, as being laser energy and/or ultrasonic energy in the energy delivered When.
Target tissue processing, which can be included in closed loop energy delivery, delivers energy, such as based on by one of the system Or the signal delivering energy of multiple sensor records.The sensor can include at least one temperature sensor and energy is passed The temperature reading based on one or more measurement is sent to control.The sensor may include impedance transducer and energy delivery base Controlled in the impedance readings of one or more measurement.The sensor may include the biography for being configured to provide for tissue thickness's reading Sensor, the sensor being such as selected from the group：Sonac；OCT sensor；OCDR sensors；And combinations thereof.Energy delivery can be with Controlled based on the tissue thickness of measurement, such as the target tissue thickness of measurement.Energy delivery can be based on being passed by one or more systems Sensor provide measurement energy delivery depth and change.Energy delivery can be controlled based on the parameter being selected from the group：Delivering Energy amount；The accumulation of the energy of delivering；The depth that energy penetrates；The depth of the processing obtained；Tissue temperature；Tissue Physical features such as color；And combinations thereof.
The target tissue of the processing may include the first target tissue part and the second target tissue part.The first target tissue portion One or more features different from the second target tissue part can be had by dividing.Different features include but is not limited to：Group Knit type and such as organize channel type；Tissue density；Tissue thickness；And combinations thereof.The first target tissue part can receive and institute The different processing in the second target tissue part is stated, the processing difference being such as selected from the group：Energy level；The energy delivery duration；Pass Tissue temperature during sending；And combinations thereof.The first target tissue part can be thinner than the second target tissue part, and The first target tissue processing can be different from the second target tissue processing, the difference being such as selected from the group：At target tissue part The temperature of reason；The energy level applied in the processing procedure of target tissue part；The duration of target tissue part processing；And its group Close.
The target tissue processing may include electromagnetic energy being delivered to target tissue, as delivered radio frequency and/or microwave energy to target group Knit.The radio frequency energy of delivering may include bipolar and/or single-stage radio frequency energy, the energy that is such as delivered by single electrode and skin electrodes or The energy delivered by electrod-array.The electromagnetic energy can apply delivering or with to target group to the single energy of target tissue part Knit the multiple application delivering of part.The target tissue may include the first tissue layer and more deeper than the first tissue layer second group Tissue layer, and the system can deliver the first processing to the first tissue layer and be delivered to the minor microstructure layer at second Reason.First energy delivery may include compared with second energy delivery with higher temperature, with higher energy level and/or With the energy delivery of longer duration.The electromagnetic energy of delivering can be ionization or unionized energy delivery.The electromagnetic energy of delivering Can be that plasma is formed or non-plasma forms energy delivery.The delivering of electromagnetic energy may cause following one kind or more Kind：Tissue removes；Ablation of tissue；Tissue contracts；And hemostasis.Electromagnetic energy can be with nearby delivering salt aqueous phase knot to the target tissue Close, such as order or simultaneously delivering salt solution.
The target tissue processing may include to deliver acoustic energy, the acoustic energy being such as selected from the group to target tissue：Ultrasonic energy；Secondary acoustic energy； And combinations thereof.The system may include at least one energy delivery elements for being configured to deliver acoustic energy, such as include crystal or pressure The energy delivery elements of dead-wood material.Multiple energy delivery elements can be configured to deliver high intensity focused ultrasound energy.
The target tissue processing may include to deliver luminous energy, the luminous energy being such as selected from the group to the target tissue：Laser energy；It is infrared Energy；It can be seen that luminous energy；And combinations thereof.The laser of delivering can may include the energy delivered by the laser being selected from the group：CO2 laser；KTP Laser；Er:YSGG laser；Er:Glass；Ho:YAG laser；Ho:YSGG laser；nd:YAG laser；Nd:YSGG；Nd:Doping swashs Light；Semiconductor laser；Excimer laser；Chlorination xenon (Xenon Chloride) laser；Argon fluoride lasers；Rear-earth-doped crystal Laser；Gas laser such as argon gas or Krypton laser；Liquid laser such as dye laser；And combinations thereof.
The target tissue processing may include to the target tissue delivery of agents and/or chemical energy.In some embodiments, The target tissue, the reagent being such as selected from the group are handled with Chemical peeling agent (peeling agent)：Acid；Phenol；Phenol/crotons；And its Combination.The system may include the output end (outlet port) for the reagent to be delivered to target tissue, such as be selected from the group Output end：Nozzle；Opening；Film；And combinations thereof.The reagent of delivering can be used for improving or facilitating delivering of the energy to target tissue, Include such as when the reagent is absorbed by one or more form of energy and/or in the reagent and be configured to support photodynamics (photodynamic) and/or during ultrasonic transmissible chromophore.The reagent can include dyestuff.
The target tissue, which blows, may include to deliver heat energy to the target tissue, such as deliver heat energy, the processing from treatment element Element includes the sacculus of hot fluid filling, is such as filled with the suitable type sacculus of hot fluid.The hot fluid may include that expansion is selected from the group Fluid：Water；Salt solution；Glycerine；Steam；And combinations thereof.The treatment element may include can heating component, what is be such as selected from the group can Heating component：Cage；Cutter；Cable；And combinations thereof.The target tissue processing may include that the first energy delivery and the second energy are passed Send, the first energy delivery such as carried out with the first temperature and the second energy delivery carried out with second temperature.The system can wrap The magnetic particle for being configured to deliver heat energy is included, such as when exposed to magnetic field, such as the magnetic field as caused by MRI.The magnetic particle Conjunctive tissue is may be configured to, is such as configured to the magnetic particle with reference to Duodenal Tissues.
The target tissue, which is handled, may include to deliver cold energy to the target tissue, such as when the system includes cold temperature source, such as One or more of source：CO2；Argon；Nitrous oxide；And liquid nitrogen.
The target tissue processing may include the mechanical transmissibility carried out to the target tissue, such as via the energy being selected from the group Delivery elements：Cutting balloon；Cut cage；The inflatable element handled with abrasive coating and/or abrasive surfaces；And combinations thereof. The system can further comprise moving transmitting assembly, so that the treatment element can rotate and/or overturn to deliver Mechanical energy, such as in a reciprocation manner.
The target tissue processing can be delivered by least one energy delivery elements of system, the energy being such as selected from the group Delivery elements：Electrode；Crystal；Cutting surfaces；And combinations thereof.The system may include at least three energy delivery elements, such as put Three or more energy delivery elements of array are set to, such as radially expandable array.
The target tissue processing may include abrasion (abrade) target tissue.The treatment element of delivering abrasion can wrap Include following one or more：Sacculus with surrounding abrasion net (surrounding abrasive mesh)；Just have one or The abrasion sacculus of multiple embeddings；With the radially expandable element of sacculus or other configurations for removing tissue.The system can wrap Include for rotating and/or overturning one or more treatment elements with the moving parts of abrasion target tissue.
The target tissue processing may include to apply fluid injection, such as delivering water；Air；CO2With one kind in steam or more The fluid injection of kind.The fluid arranging processing is typically configured to cause target tissue to remove or otherwise turn into non-functional Property.
The target tissue processing may include to deliver at least two form of energy.The system may include to be used to deliver the first energy First treatment element of amount form and the second processing element for delivering the second form of energy.Described two form of energy can be with Simultaneously or sequentially deliver.First form of energy can be delivered to the first target tissue part, and second form of energy can To be delivered to the second target tissue part.In one embodiment, first form of energy includes abrasion target tissue.Institute Stating the second form of energy may include to deliver heat energy and/or delivering electromagnetic energy such as radio frequency energy from hot fluid sacculus.
Methods described can further comprise the body cavity (body lumen) and/or body cavity of elongate tube distal portion insertion patient (body cavity).The position that the body cavity (body lumen) and/or body cavity (body cavity) can be selected from the group：Stomach Enteron aisle；Esophagus；Stomach；Pylorus；Duodenum；Jejunum；Lung；Bladder；Nasopharynx；Colon；Air flue；Oral cavity；And combinations thereof.
The service aisle that methods described can further comprise entering at least one of elongated tubular into device through body inserts, The body being such as selected from the group enters device：Endoscope；Laparoscopic port；Enter device through stomach；Blood vessel guiding device；And combinations thereof.Institute State at least a portion of elongated tubular and can be loaded with front loading (front-loaded) or rear portion to the body and entered in device.
Methods described can further comprise promoting, recall and/or rotating the elongate tube distal portion, such as promote, recall and/ Or one or more treatment elements of the rotation elongated tubular.
Methods described can further comprise deflecting the elongate tube distal portion, such as pass through the yoke assembly of activation system.Institute The bracing wire that yoke assembly may include to be withdrawn or promote, or the bending mandrel being inserted into are stated, and may include to be configured in mistake Cross to the shape memory material for changing shape during body temperature.The elongate tube distal portion can deflect so that the elongated tubular and/or Treatment element contacts target tissue.
Methods described can further comprise promoting, recall and/or rotating the second elongated tubular, such as be slided and connect by the first elongated tubular The second elongated tubular received or the second elongated tubular arranged with side-by-side configuration.Second elongated tubular may include one or more processing Element.
Methods described can further comprise inflating inflatable element, such as comprising one in sacculus, cage and radial direction extendable arm Kind or a variety of inflatable elements.The treatment element may include inflatable element or its can be fixed on inflatable element.Institute The method of stating can further comprise inflating second inflatable element, such as include the second inflatable element for the treatment of element.Described first Or the second expansive force on inflatable element can be different, such as apply for changing to the processing of target tissue.Expansive force changes Become can change it is following one or more：The energy of delivering；The depth of processing；With the power applied by abrasion element.It is swollen The change of expansive force can cause the change of the electromagnetic energy of delivering, such as be used to increase delivering by the impedance reduced under highly expanded power Radio frequency energy.
Methods described can further comprise obtaining signal from one or more sensors.One or more sensors can be fixed In the elongated tubular and/or treatment element.One or more of sensors can be fixed on inflatable element, and the side Method may include to expand the element, such as having sensor contacts tissue.Methods described may include to be based on from one or One or more signals adjustment target tissue processing that multiple sensors receive, such as includes being selected from one or more of sensors During the sensor of the following group：Heat sensor, such as thermocouple；Impedance transducer, such as tissue impedance's sensor；Pressure sensor；Blood Sensor；Optical sensor, such as optical sensor；Sonic transducer, such as ultrasonic sensor；Electromagnetic sensor, as electromagnetic field senses Device；And combinations thereof.Methods described may include the temperature adjustment target tissue processing based on measurement, be such as fixed among treatment element, On or close to the treatment element temperature sensor.Methods described may include to position sensor on the tissue walls, and such as ten Two duodenum 12 tissue walls.Methods described may include sensor being positioned in tissue, in submucous tissue, such as in submucosal injections Placed in program process.Described that hair of expense may include to obtain patient parameter information from one or more of sensors. The patient parameter information may include the information being selected from the group：Temperature information such as tissue temperature information or treatment element temperature；Resistance Anti- information such as tissue impedance's information；Pressure information；Blood flow information；Blood sugar level；Insulin level；Hyperglycemic factor water It is flat；GIP, GLP-1, GLP-2 and/or other gastrointestinal hormones are horizontal；And combinations thereof.Methods described may include based on temperature and/or Impedance readings adjustment target tissue processing, is such as adjusted to radio frequency energy or hot fluid transmissibility.Methods described may include to be based on by myoelectricity The signal adjustment target tissue processing that map sensor receives, such as represent the signal of muscular layer of mucosa electromyogram.Methods described may include base In the signal adjustment target tissue processing from the sensor being selected from the group：Quantitative heat sensor；Serum levels sensor；Imaging Sensor is such as configured to produce the sensor for representing the tissue color such as signal of chorionic villi color；And combinations thereof.The side Method may include based on the signal adjustment target processing received from imaging sensor, as the imaging for producing the signal for representing following content passes Sensor：Image tissue thickness；Image tissue blood vessel；It is imaged ice hockey present in cold energy delivering；And combinations thereof.Imaging sensor leads to It is often the imaging sensor being selected from the group：X-ray such as fluorescope；CT is imaged；MRI；Ultrasonic imaging；Molecular imaging；Nuclear imaging is such as With or without the nuclear imaging of glucose-tolerant test；OCT；Spectrum such as Tera-Hertz spectrum；And combinations thereof.
Methods described can further comprise the activation of function element, elongated tubular and/or treatment element as described in being fixed on Function element.The function element can be the element being selected from the group：Sensor；Conductor；Vacuum ports；Visualize element or Device such as ultrasonic crystal or optical module；And combinations thereof.The function element may include vacuum ports and methods described includes Applying vacuum is so that another part of the treatment element, the elongated tubular and/or system is produced with tissue such as target tissue and contacted. Methods described may include to remove tissue target tissue treated as before by vacuum ports.The function element may include visually Makeup is put, and methods described can further comprise producing one or more images from the visualization device.It is typical visual Makeup is put including but not limited to：Visible Light Camera；Ultrasonic imaging device；Optical coherent chromatographic imaging instrument；And combinations thereof.
Methods described can further comprise delivering pressure fluid via the body cavity pressure-applying unit of system.One or more stream Body, such as liquid and/or gas, the chamber that device such as endoscope is entered by the chamber and/or body of elongated tubular is delivered to patient, such as by This is blown into (such as expansion) body cavity (body cavity) or body cavity (body lumen) such as duodenum.Fluid can pass through System the second elongated tubular delivering, such as by body enter device promote the second elongated tubular, the body into device such as together with The endoscope of first elongated tubular, fluid deliver in identical or different endoscopic working channel.The blocking element of system can be with Expansion, such as it is used to preventing the fluid migration that delivers or otherwise causes delivered fluid to be maintained in specific chamber or body Chamber position.Blocking element is usually fixed at elongated tubular.Fluid can be higher than about 0.5cm H2O pressure delivering and/or holding In the H higher than about 0.5cm2O pressure.Fluid can be with the H less than about 15cm2O pressure delivering.
Methods described can further comprise the body of system being positioned over patient's body, such as endoscope into device.Or Or in addition, the body that can be inserted into patient, which enters device, may include following one or more：Laparoscopic port；Enter device through stomach； With blood vessel guiding device.The elongated tubular may be inserted into body and enter device, such as load flow via front loading or rear portion.
Methods described can further comprise producing one or more patient images from the imaging device of system.The imaging dress Patient can be inserted into by putting, and such as enter device such as endoscope by body.What the imaging device may include to be selected from the group can be inserted into Imaging device：Visible Light Camera；Ultrasonic imaging device；OCT imager；And combinations thereof.The imaging device may include outside imaging The imaging device that device is such as selected from the group：X-ray；Fluorescope；Ultrasonic imaging；MRI；PET scanner；And combinations thereof.
Methods described can further comprise activation energy delivery unit, such as be configured to carry for one or more treatment elements The energy delivery unit of the system of energy supply amount.Energy delivery elements can deliver one or more in the form of open loop or closed-loop delivery Form of energy.
Methods described can further comprise active controller and/or user interface.The user interface may include to be used to adjust The graphical user interface of whole one or more system input parameters.System input parameter may include the parameter being selected from the group：Pass The kind of energy sent, such as RF energy, heat energy and/or mechanical energy；The joule of the amount for the energy the to be delivered energy such as to be delivered adds up The peak value of value or the energy to be delivered；The type and level of the energy to be delivered combination；The energy delivery duration；The energy of delivering The pulse width modulation percentage of amount；The reciprocating motion number for moving abrasion device lateral；Temperature such as mesh for treatment element Mark temperature or maximum temperature；It is blown into pressure；It is blown into the duration；And combinations thereof.The system input parameter can be selected from down The operation consent parameter or Perinatal Therapy parameter of group：Mucous membrane density and/or thickness；Mucous membrane " carries " from lower floor after submucosal injections Rise；The longitudinal register of intestines and stomach inner target tissue；And combinations thereof.Methods described can further comprise display system output parameter.System System output parameter may include the parameter being selected from the group：Temperature information such as tissue and/or treatment element temperature information；Pressure information is such as Balloon pressure information is blown into pressure information；The information of power such as puts on the horizontal information of the power of tissue；Patient information is such as by one The patient physiological information of individual or multiple sensor records；And combinations thereof.Methods described may include to originate, relax and/or stop by The processing for the treatment of element delivering.Methods described may include to originate, relax and/or stop the energy being delivered by treatment element.It is described Method may include to store energy delivery information.
Methods described may include to move one or more system components with motion transfer element, such as described elongated tubular and/or One or more treatment elements.The motion transfer element can cause one or more system elements to rotate and/or overturn, such as past Multiple rotation and/or upset.In some embodiments, treatment element and/or system component rotate and turn over simultaneously.In some realities Apply in scheme, the treatment element includes the abrasion device by moving rotation and/or upset.The motion transfer element can The element driven including motor-driven components and/or operator.
Methods described may include among non-target tissue, on or be placed around protective cap, the non-target tissue such as liver pancreas Pipe ampulla and/or oddi's sphincter.Methods described may include to remove protective cap, such as be positioned in patient in twenty four hours.
Methods described may include to cause tissue expander, such as target tissue or the tissue of close target tissue.Tissue expander may include Tissue expander is caused with the tissue distention device of system, is such as configured to expand the tissue expander dress of duodenal mucosa undertissue Put.The tissue distention device may include one or more syringe needles or water jet nozzle, be configured to deliver tissue expansion fluid Such as salt solution.Tissue expander can be carried out at multiple positions, such as the first target tissue part and the second target tissue part processing before and/ The expansion carried out during or.
Methods described may include to operate tissue, such as with the manipulation device of system.Tissue operation is typically configured to make Into following one or more：The axially aligning such as aligning of duodenum or other intestinal tissues；Tension adjustment (tensioning) Such as axially and/or radially tension adjustment；Thickness expansion with the fluid (such as liquid or gas of injection) of injection as carried out The expansion of intestinal submucosa；Apply axial force to tissue；Apply reverse axial force to tissue；Apply radial load to tissue；Pressure Contracting tissue such as compresses duodenal fine hair；Trigger local edema or angioedema；With radial dilatation duodenum as being used to subtract Few valvulae conniventes are protruded and prevented or reduce undertreatment caused by folds in a garment is folded up these folds in a garments due to treatment element.The side Method may include one or more parts of radial dilatation manipulation device, as include it is following in one or more parts： It is blown into sacculus；Inflatable cage and extendable arm such as radial direction extendable arm.Methods described may include to expand the two of manipulation device Individual or more radial dilatation part.In some embodiments, the first handle and the second footpath are fixed in the first radial dilatation part The second handle is fixed on to expansion, second handle is slided by the first handle and received.In expansion to contact tissue such as duodenum Cavity wall tissue after, the relative positioning of the first expansion and the second expansion can be used for (such as opening to tissue applying power Pulling force).Methods described may include that delivering is blown into fluid, such as by endoscope and/or the elongated tubular of system with operate tissue (such as With expanding tissue).Methods described may include to block chamber or body cavity completely or partially, such as be blown into fluid from thinking to tissue delivery The position to be expanded migration is otherwise operated.Methods described may include one or more tissue penetration devices of advancing by leaps and bounds, such as For engaging (engage) tissue and applying one or more power to tissue.
Methods described can further comprise delivery of agents, the reagent such as delivered to patient system's property.The reagent may include The reagent being selected from the group：Antibody；Steroids；Mucous membrane cryoprotector such as ulcerlmin；Proton pump inhibitor or other sour blocking agents Thing；And combinations thereof.
Methods described can further comprise that flow is completed to confirm the activation of algorithm.The algorithm may include time-based calculation Method, such as monitor the algorithm that energy is delivered to the time of tissue.The algorithm may include the algorithm of Behavior-based control, such as be based on being selected from The algorithm of the parameter of the following group：The energy level reached；The power level reached；Jiao of the energy level delivered such as RF energy Ear predetermined value；Machine cycle number such as the reciprocating motion group reached；The face that the tissue change having occurred and that such as has occurred and that Color change, texture variations or other visible changes；Tissue impedance and/or tissue impedance have reached the change of threshold value；Temperature and/ Or the change of the change of temperature such as temperature and/or tissue temperature has reached threshold value；The change of blood flow and/or blood flow Threshold value is reached；The change of hormone serum level and/or hormone serum level has reached threshold value；Blood sugar level and/or blood The change of sugar level has reached threshold value；Connective tissue exposes under mucous membrane, such as works as by visual inspection or chemistry and/or biology inspection When surveying mechanism detection；And combinations thereof.
According to another aspect of the present invention, the system of the disease and/or illness for the treatment of patient includes treatment element.The place Reason element is constructed and arranged the region for changing intestines and stomach, described to change selection the following group：Athrocytosis；Cytohormone Release；And combinations thereof.
According to another aspect of the present invention, the system of the disease and/or illness for the treatment of patient includes treatment element and tissue Stent assembly.The treatment element is constructed and arranged for handling target tissue and the tissue expander component is fabricated and cloth Put for expanding the tissue near target tissue and/or target tissue.
According to another aspect of the present invention, treating the method for diabetes in patients includes the selection patient 12 to be removed finger The target region of intestines and the duodenal mucosa for removing patient, while keep stomach and jejunum of patient's duodenum relative to patient For be anatomically complete.Target region includes being connected with the region at least one the jejunal mucous membrane of patient and gastric mucosa Duodenal mucosa region.
Methods described includes removing the stem cell in duodenal mucosa.
Methods described may include to remove duodenal mucosa by melting duodenal mucosa.It can provide including ablation The sacculus of element such as RF component, is positioned in duodenal mucosa to melt duodenal mucosa.
Methods described may include to remove duodenal mucosa by shaving and/or striking off duodenal mucosa.It can carry Shaving and/or striking off to duodenal mucosa is caused for the sacculus including cutter device.
According to another aspect of the present invention, the duodenal mucosa that the method for diabetes in patients includes removing patient is treated And the jejunal mucous membrane of patient is promoted to be grown at the duodenal mucosa being removed.Carry out the duodenal mucosa of the patient Remove so that the duodenum of the patient keeps anatomically complete relative to the stomach and jejunum of patient.
Methods described may include to remove the stem cell in duodenal mucosa.
Methods described may include to remove duodenal mucosa by melting duodenal mucosa.It can provide including ablation The sacculus of element such as RF component, it is positioned in duodenal mucosa to melt duodenal mucosa.
Methods described may include to remove duodenal mucosa by shaving and/or striking off duodenal mucosa.It can carry Shaving and/or striking off to duodenal mucosa is caused for the sacculus including cutter device.
Methods described may include to promote the jejunal mucous membrane of patient to grow by providing barrier to gastric mucosa, the barrier group Gastric mucosa is knitted to grow at the duodenal mucosa being removed.
According to another aspect of the present invention, treating the method for diabetes in patients includes obtaining the bile salt and pancreas of patient Enzyme, the bile salt and the pancreatin not food reaction with patient's intake；And the unreacted bile salt and pancreatin are delivered To the duodenum of patient.
According to another aspect of the present invention, treating the method for diabetes in patients includes obtaining the bile salt and pancreas of patient Enzyme, the bile salt and the pancreatin not food reaction with patient's intake；Organize the food of intake and the bile salt and pancreatin of patient Reaction；The food of intake and the duodenal mucosa of patient is organized to react；Patient is delivered to by the bile salt of acquisition and pancreatin Jejunum.
According to another aspect of the present invention, include removing 12 fingers of patient for treating the system of the diabetes in patient The device of intestinal mucosa so that it is described remove keep patient duodenum relative to patient stomach and jejunum anatomically It is complete.The effect for the treatment of is that the jejunal mucous membrane for promoting patient grows at the duodenal mucosa being removed.
The processing unit of duodenal mucosa for removing patient can be adapted to remove dry in duodenal mucosa Cell.
Processing unit for removing patient's duodenal mucosa can be made into ablation duodenal mucosa.The processing Device may include to be configured to the sacculus for melting duodenal mucosa.The processing unit can use radio frequency energy.The system Can further comprise being configured to shave and/or strike off duodenal mucosa shave and/or removing device.It is described shave and/ Or removing device may include the second sacculus for being configured with cutter device.The processing unit can be adapted for forming gastric mucosa Barrier, the barrier tissue gastric mucosa grow at the duodenal mucosa being removed.
According to another aspect of the present invention, for treat diabetes in patients system include obtain patient bile salt and The device of pancreatin, wherein the not food reaction with patient's intake of the bile salt and pancreatin；With it is described unreacted for delivering Bile salt and pancreatin are to the duodenal device of patient.
According to another aspect of the present invention, include being used for the bile for obtaining patient for treating the system of diabetes in patients The device of salt and pancreatin, wherein the not food reaction with patient's intake of the bile salt and pancreatin；It is adapted for preventing intake Food and the device of the bile salt and pancreatin of patient reaction, wherein preventing that the duodenal mucosa of the food and patient taken in is anti- Should；With for deliver obtain bile salt and pancreatin to the jejunum of patient device.
Inventive concepts described herein, and its attribute and possessed advantage, in the following detailed description of the invention of reference together with accompanying drawing In the case of can be best understood by and understood, describe representative in an exemplary fashion in following detailed description of the invention and accompanying drawing The embodiment of property.
Brief description
The advantages of above-mentioned technology, and further advantage, can preferably it be managed by reference to following description and accompanying drawing Solution.What accompanying drawing was not necessarily to scale, emphasis and be non-generically placed in this to explain the principle of this technology.
Fig. 1 illustrates the specific related anatomical features in people's stomach and intestine (GI) road.
Fig. 2 illustrates the cross-sectional view of small intestine.
Fig. 3 illustrates the cross section for being used to handle the distal portion of the system of tissue of the embodiment according to present inventive concept Figure.
Fig. 3 A illustrate the potential processing region of the intestines and stomach of the embodiment according to present inventive concept.
Fig. 4 illustrates the schematic diagram for being used to handle the system of tissue of the embodiment according to present inventive concept.
Fig. 5 illustrates the flow chart for being used to handle the method for tissue of the embodiment according to present inventive concept.
Fig. 6 illustrates the flow chart for being used to handle the method for tissue of the embodiment according to present inventive concept.
Fig. 7 illustrates the flow chart for being used to handle the method for tissue of the embodiment according to present inventive concept.
Fig. 8 A and 8B respectively show according to the embodiment of present inventive concept before axial force is applied to target tissue and The sectional view of the distal portion of tissue processing system afterwards, the tissue processing system include two tissue operating elements.
Fig. 9 illustrates the distal portion sectional view of the tissue processing system of the embodiment according to present inventive concept, described Tissue processing system includes inflatable treatment element and two tissue operating elements.
Figure 10 illustrates the tissue processing system for including inflatable treatment element of the embodiment according to present inventive concept The side view and end-view of distal portion, the inflatable treatment element include more blastomere capsules.
Figure 11 illustrates the tissue processing system for including inflatable treatment element of the embodiment according to present inventive concept The side view of distal portion, the inflatable treatment element include multi-electrode cage.
Figure 12 illustrates the side view of the tissue processing system of the embodiment according to present inventive concept, the tissue treatment System includes two tissue treatment elements, the net abrading apparatus that sacculus is supported and the sacculus for being configured to accommodate hot fluid.
Figure 13 A and 13B illustrate the sectional view of the target tissue extension fixture according to the embodiment of present inventive concept.
Figure 14 illustrates the flow chart for the operating procedure for being used for treating diabetes according to the embodiment of present inventive concept.
Figure 15 illustrates the flow chart for the operating procedure for being used for treating diabetes according to the embodiment of present inventive concept.
Figure 16 illustrates the flow chart for the operating procedure for being used for treating diabetes according to the embodiment of present inventive concept.
Figure 17 illustrates the flow chart for the operating procedure for being used for treating diabetes according to the embodiment of present inventive concept.
Figure 18 illustrates the protective cap of the ampulla hepatopancreatica of the embodiment according to present inventive concept.
Accompanying drawing is described in detail
With detailed reference to the embodiment of present inventive concept, the example is shown in the accompanying drawings.In all possible situation Under, same or similar part can be referred to using identical reference in all of the figs.
The purpose of terms used herein is to describe specific embodiment, and is not intended to limit idea of the invention.Such as It is used herein, singulative "one", " one kind " and " described " be intended to include plural form simultaneously, unless civilization up and down Really there is opposite expression.It should also be understood that term "comprising" and/or " comprising " are as used herein, institute is specified Features set forth, integer, step, operation, the presence of element and/or component, but do not allot presence or addition it is one or more/mono- Or other multiple features, integer, step, operation, element, component and/or their group.
It should be appreciated that while may have been used term first, second, third, etc. herein describe different restrictions, element, Component, region, layer and/or part, but these restrictions, element, component, region, layer and/or part should not be restricted by these terms Limitation.These terms are only used for a kind of restriction, element, component, region, layer or part and another restriction, element, group Part, region, layer or part distinguish.In this way, the first restriction discussed below, element, component, region, layer or part can also It is referred to as the second restriction, element, component, region, layer or part, but without departing from teachings of the present application.
It will also be understood that element be mentioned as another element " on " or " connection " or " coupling " in another element when, it can Be directly over or on, or be connected or coupled to another element, or there may be the element of centre.Relative, Element is mentioned as " directly on another element " or " being directly connected to " or " direct-coupling " when another element, in the absence of centre Element.Other terms for describing relation between element should understand in a similar way (for example, " between " relative to " directly in-between ", " adjacent " is relative to " direct neighbor " etc.).It is mentioned as herein in another element " it in element During upper (over) ", it can be on or below another element, and be coupled directly to another element, or there may be centre Element, or the element can pass through space or spaced apart.
Implemented by the system of present inventive concept, device and treatment element and in cell or tissue (such as mucous layer) Processing under linguistic context, which can refer to, causes cell death, apoptosis, Transient cell death, the denaturation of meronecrosis, cell；The shifting of cell Remove, and/or so that other changes for the cell that secretion (such as hormone secretion), absorption or other functions of cell are changed or organized Change, and/or the cell being processed is substituted by the neoblast for having different secretions or other functions compared with before processing cell.This The modification to target tissue cell may quickly occur (when applying, such as within the period less than 24 hours) or may a bit Through when occur (such as subsequently to cause the irreversible damage of cell death, it generally occurs within the period more than 24 hours, such as In period more than one week).The context that the other application of term " processing " passes through specification should be clear.It can go Except the cell being processed, such as by abrasion device or by using laser vaporization.The cell being processed can still have But it is changed into non-functional.The cell being processed, the cell such as handled by heating ablation, damaged because of high temperature or low temperature exposure Wound.The removal of these damaged cells is mediated by inflammatory response, and it identifies damaged cell and removed it.Bacterium, in enteron aisle Existing bacterium, damaged cell can also be decomposed and thus removed it.Be subject to processing cell can also simply under intestinal wall is sloughed off, Then discharged by body.
System, the method and apparatus of present inventive concept can build and arrange for treating different disease and illness, wrap Include diabetes.The research to the diabetes origin cause of formation and the mechanism of control discloses the origin cause of formation of diabetes in the recent period and processing may be with stomach and intestine (GI) road and particularly small intestine is closely related.Live through gastric bypass operation patient show diabetes B symptom reduction or Disease is disintegrated completely.Therefore bypass that some recent study propose duodenum and/or jejunum is probably a kind for the treatment of The method of diabetes B in patient.A kind of theory is based on such a concept, i.e. the upper enteron aisle of diabetic is probably to produce The region of abnormal hormone signal conduction, causes or facilitates the formation of diabetes.Diabetes B may come from duodenum and sky The excessive secretion of intestines moderate resistance secretin, thus reduce insulin secretion and block insulin action.Secretin is gastrointestinal hormone, its Flowing in response to nutrients produces and increases insulin and produces.The secretion and effect of the secretion increase insulin of secretin. However, anti-secretin suppresses the secretion and effect of insulin.Diabetes B may be due in duodenum and jejunum what is assumed The excessive secretion of anti-secretin, thus reduce insulin secretion and block the effect of insulin.In the case of this hypothesis, need The correct balance of secretin and anti-secretin is wanted to keep the normal glucose levels in blood.Become to be known as pancreas islet in cell During resistance (situation for causing a kind of " insulin resistance "), and enough insulin can not be produced to handle body institute in pancreas During the glucose load being subjected to, diabetes are just produced.It was found that gastrointestinal bypass operation technique seems by the way that upper part of small intestine (is wrapped Include duodenum and close jejunum) discharge outside nutrients transport and improve the clinic of the patient with diabetes B Symptom.This bypass changes the amount from the hormone of the hormone-producing cells release in GI roads (by increasing the generation of secretin simultaneously The potential generation for reducing anti-secretin), thus cause the improvement to diabetes B.
Ren GI roads related to inventive concept disclosed herein are partially shown in Fig. 1.The GI organs shown include liver 102, courage Capsule 104, choledochus 108, pancreas 110, ductus pancreaticus 112, duodenum 114, ampulla hepatopancreatica 118, oddi's sphincter 120 and stomach 122.Duodenum 114 is generally about 25cm.It originates in the pylorus on right side in the C-shaped process of head of pancreas 110, And left side duodenojejunalis junction is terminated at, it is incorporated to jejunum there.Junction form generally at an acute angle, duodenum Jejunum campylobacter is supported by ligament of Treitz (not shown).Claiming from liver and the conduit 112,108 of pancreas delivering bile and pancreatic juice The transfer point for making ampulla hepatopancreatica 118 converges and injected close to duodenum 114, ampulla hepatopancreatica 118 by duodenofiberscope Duodenum 114.Ampulla hepatopancreatica 118 with ductus pancreaticus 112 and choledochus 108 with reference to and formed.Ampulla hepatopancreatica 118 is located at Along at about half of the Part II of duodenum 114.Oddi's sphincter 120 is that control digestive juice passes through ampulla hepatopancreatica 118 Into the valve of the flowing of the Part II of duodenum 114.
Fig. 2 illustrates the cross section of small intestine 200.As shown in fig. 1, duodenum 114 is present in most vertebrate Including in people, and form the Part I of small intestine 200.The (not shown) before jejunum of duodenum 114, its formation are small The Part II of intestines 200.Duodenum 114 also includes duodenal mucosa 201, and it forms the innermost layer of duodenum 114, also Including mucous membrane under duodenum 203, it is made up of the connective tissue layer of support duodenal mucosa.Similar to duodenal mucosa With lower mucous membrane, mucous membrane (not shown) under jejunal mucous membrane and jejunum be present along jejunum.
As shown in Fig. 2 small intestine 200 includes intestinal villus 202.Intestinal villus 202 is that tiny finger sample protrudes, and it is from small intestine 200 wall extends.Intestinal villus 202 has the extra protrusion (not shown) for being referred to as microvillus.Nutrients through digestion, bag Glucose is included, is absorbed into vivo by the cell of intestinal villus 202, is then taken away by circulating lymphatic system and blood.Intestines glue Film is made up of several layers of layers anatomically with different configuration, function and form.In the region of small intestine 200, intestinal mucosa with Lamina propria basalis is interlaced.Intestinal mucosa is by three kinds of neurohyophysis (enteroendocrine, cup-shaped and paneth's cell) and one kind Cell type (enterocyte) is absorbed to form.Nutrients, which is transported and absorbed, to be occurred in enterocyte, and sophisticated signal conducts Between various kinds of cell type of the generation in mucous membrane.Specifically, presence or scarce of the enteroendocrine cell in response to local signal Lose and releasing hormone, it is generally triggered by the presence and component of intracavitary nutrients.The bases of intestinal mucosa crypts (crypt) Stem cell produces this all four kinds of cell type, and the habit of these cells is defined on science of heredity and on apparent and science of heredity Property and characteristic.When stem cell division, they can either produce sub- stem cell or can produce the " of short duration of intestinal mucosa cells Expand (transit amplifying) " colony.Transit amplifying cells divide rapidly, and begin to differentiate into above-mentioned four kinds of cells Type.Enteroendocrine cell, enterocyte and goblet cell migrate towards enteric cavity, and paneth's cell migrates back the base of crypts Bottom, there they build a Stem Cell Niches (stem cell niche), stem cell occupy wherein.These cells are towards chamber Migration, and finally as they are released by the cell for appearing in the new division below them and are absorbed in intracavitary.Due to single crypts- Whole cells of fluff structures are produced from the stem cell of crypt base, this importance to rejuvenate with regenerative process It is that the phenotype, habit and feature of crypt-villus architecture are limited by the stem cell properties of the crypt base.By this way, The performance in the intestinal villus area (as being mucous membrane relative to intestinal mucosa) with different structure and phenotype is different (major part), and reason is point Not in the different differentiation characteristics of the stem cell of gastric mucosa and intestinal mucosa substrate.Circumferentially, the mucous membrane in any region of small intestine is big It is identical in cause.However, in the axial direction, greatest differences be present, such as pass through the difference in Stomach duodenum, jejunum mucous membrane characteristic Observed.
Term " target tissue " should include needing the system by present inventive concept, the tissue of method and apparatus processing.Suffer from The tissue of person, include the target tissue of patient, it may include the tissue volume of a variety of geometries.Tissue is reported to be managed including one or more layers Shape structure, such as one or more layers tubular portion of intestines and stomach.Target tissue can be limited by length, width and depth, Huo Zheqi It can be limited by other three-dimensional definition parameters.Target tissue length can include tissue surface length, such as tubular tissue conduit Length, such as duodenum or the length of the part of other stomach intestinal tissues.Target tissue width may include the width of tissue surface, such as The width of circumferential section including tubular tissue conduit, such as circumferential part of one or more layers tubular tissue layer between 1 ° to 360 ° Point.Part-circular periphery target tissue should refer to the target tissue or target tissue part less than 360 °.Circle target tissue should refer to covering all circles The target tissue in week or target tissue part (such as intestines and stomach is one or more complete or part layer 360 °).Target tissue depth can Protruded including the tissue depth under tissue surface, such as the depth of the tissue protruded from the inwall of tubular tissue conduit, such as extremely Include the depth of duodenal intact mucosal layer less.Organized layer may include whole layers or part layer or the group anatomically classified Tissue layer, such as the mucous membrane and submucosa of intestines and stomach.Whole layers may include two or more part layers, such as duodenal mucous membrane Lower floor, it includes the layering of the first penetralia and the layering of the second most external.All or part of layer can have constant depth (such as thick Degree) or with target tissue length and width change depth.
According to the embodiment of present inventive concept, (such as removal) duodenal mucosa can be handled, while keep 12 (that is, being complete relative to GI roads) that duodenum 12 114 is anatomically connected to.Duodenal one or more can be handled Longitudinal component, typically duodenal whole length or its substantive longitudinal component.The one of Duodenal Tissues can be handled Layer or multilayer, generally include the full circumferences (such as 360 °) along surface and the extension of intact mucosal thickness degree.In an implementation In scheme, the substantial portions of the full depth of target tissue including mucous membrane, including long fine hair, mucous membrane substrate layer, And transit amplifying cells.This target tissue includes the substantially whole circumference of tubular tissue and axially consecutive part, and it is along intestines Target treated length extends.Select target volume (being limited by target tissue length, depth and circumferential section) desired to realize Therapeutic effect.Processing to the full-thickness (layer for being included in mucous membrane substrate) of duodenal mucosa prevents the office of mucous membrane Portion's regrowth and the modification for causing intestinal mucosa cells habit in processing region.Processing to mucous membrane area can change in intestines given area The function and habit of both absorption cell and the region endocrine cell.The processing of modification target tissue habit can be configured to change The region for becoming intestines absorbs the ability of the nutrients from dietary intake.The processing also can be configured to change direction and come from The autocrine of enteroendocrine cell and paracrine signal transduction and/or secretion in the target region.In one embodiment, for The given area of intestines, configuration are handled to change the autocrine and paracrine signal transduction between secretion and absorption and secretory cell Communication.In another embodiment, handled for the given area of intestines, configuration to change the absorbent properties of cell.In this Shen Various other target tissue sites should be considered within spirit and scope please, and can be retouched in detail according to below with reference to Fig. 3 A The mode stated selects.
Fig. 3 is illustrated according to the system for being used to handle tissue among the embodiment of present inventive concept, insertion body cavity The sectional view of distal portion.System 300 builds and arranged to be included below with reference to one or more of groups of Fig. 3 A for handling Knit the target tissue 10 of part.System 300 includes elongated devices 301, and the elongated devices 301 have been inserted into the body cavity of patient, should Body cavity is such as the duodenum or other parts of patient's gastrointestinal tract.Elongated devices 301 include axle 311, and the axle 311 has distal end 312.Axle 311 be usually flexible shaft, and can be configured by such as endoscope, laparoscopic port, through stomach enter device or The patient bodies such as blood vessel guide enter device and inserted.Axle 311 can be configured to front loaded or rear end and be encased in such as interior peep Mirror etc. enters among device.When axle 311 includes radial compression or can not being in addition not suitable for the service aisle of endoscope During interior one or more distal components, rear end can be used to load.Device 301 also includes one or more tissue treatment elements, Such as element 320 and element 321, each of which are installed to the distal portion of axle 311, and are each configured to as this specification is complete Target tissue is handled like that described in text configurations numerous everywhere.Axle 311 has advanced into, rotates and/or otherwise positioned, and makes Obtain treatment element 320 and/or 321 and be positioned proximate to tissue to be dealt with, i.e. target tissue 10.In one embodiment, Treatment element 320 and 321 is installed to two different axles --- and the second axle is not shown, but is normally slidably engaged in axle 111 It is and co-axial --- so that treatment element 320 and treatment element 321 independently can be promoted and retracted.Body cavity can be for example by making Pressurizeed with one or more standard injection techniques and/or below with reference to the technology described in Fig. 5, Fig. 8 A and Fig. 8 B.Note Entering fluid can be introduced by one or more chambers of axle 311, and the chamber is not shown, but is proximally advanced and be connected to injection liquid Body or gas source.Device 301 can be inserted by the endoscope for being not shown but being described in detail below with reference to Fig. 4, and pass through endoscope Chamber deliver injection fluid.
Device 301 may include one or more functions element, all function element 315 for being installed to axle 311 as shown in FIG.. Typical function element includes but is not limited to：Sensor；Transducer；Vacuum port；Visualize element or device, such as ultrasonic crystal Or optics assembly；And combinations thereof.In one embodiment, vacuum port is configured to remove and is ablated to or the tissue of debridement. Alternatively or additionally, vacuum port is configurable to make axle 311, treatment element 320 and/or treatment element 321 with tissue connect Touch.In another embodiment, function element is visualization device, such as：Visible Light Camera；Ultrasonic imaging device；And/or optics Coherence tomography visualization device.
Treatment element 320 and 321 is configurable to perform similar or different tissue treatment.Treatment element 320 and/or The 321 multiple independent processing with being configurable to order of delivery or simultaneously carried out, such as abrasion or another form of Energy delivery.Multiple independent tissue treatments can be carried out（For example, treatment）, to improve treatment results and/or limitation adverse events.
Treatment element 320 and/or 321 can be such as by including being configured to be in contact so as to for example with handled tissue Expanded during being contacted with the tissue to the expansible cage of tissue delivery energy, sacculus and/or one or more extendable arms. Treatment element 320 and/or 321 can include conformal configuration or non-conformal structure, such as conformal sacculus or non-conformal sacculus.Conformal place Reason element can build and be arranged to the different-shape for meeting target tissue and the tissue close to target tissue.Treatment element 321 and/or 321 are configurable to expand or shrink, for example expand or receive when promoting or retracting in the larger or smaller diameter portion in chamber Contracting.For gastrointestinal applications, treatment element 320 and/or 321 is typically configured to diametrically expanding at least 1cm, more generally exists Diametrically expand at least 2cm.The expansion for the treatment of element 320 and/or 321 has generally left such as interior peep in the distal portion of axle 311 The body such as mirror or laparoscopic port is carried out after entering device.Treatment element 320 and/or 321 can be via the hand in addition to expansion Section contacted with tissue, such as when axle 311 distal portion can for example by the activation of deflecting element 318 and radial deflection when situation Like that.Deflecting element 318 is generally comprised by tensioning（Such as lever or other controls on the near-end by activating device 301）With Make the bracing wire that axle deflects, or be inserted into the bending mandrel among axle 311（For example, Nitinol or other shapes memory are closed Golden axle, it is configured to bend when transitting to body temperature from room temperature）.
Treatment element 320 and/or 321, which is configurable to such as utilize, passes through such as treatment element 320 and/or 321 and target The laser energy or ultrasound energy organized the gaps such as the liquid between 10 or gas and delivered, pass through certain intervals distance（For example, processing The distance between element 320 and/or 321 and target tissue 10）To deliver energy.
Can continuously and/or in different forms and/or level delivers energy, so as to realize it is different and/or Desired treatment results.Energy delivery can be such as by using pulsewidth modulation and/or time division multiplexing（TDM）And carry in a pulsed fashion For.During single energy is applied, such as when below with reference to the energy delivery elements described in Fig. 8 A rotationally and/or translationally, Energy delivery can change.
Energy delivery can be described in detail below with reference to Fig. 7, be provided in a closed loop manner.Energy delivery amount and duration can Based on one or more sensors from system 300（Such as, function element 315）Feedback.Sensor is configurable to monitor One or more systematic parameters or patient parameter, these parameters include but is not limited to：Energy delivery amount；Cumlative energy delivering amount； Energy penetrating depths；The depth of caused processing；Tissue temperature；Organize physical characteristic, such as color；And combinations thereof.
Treatment element 320 and/or 321 is configurable to deliver the energy of one or more forms.The typical energy delivered Amount includes but is not limited to：Electromagnetic energy, such as radio frequency（RF）Energy and microwave energy；Plasma energy, such as it is used for the argon plasma energy solidified；Sound Can, such as ultrasonic energy；Luminous energy, such as laser energy, infrared energy and visible luminous energy；Chemical energy；Heat energy, such as heat energy or cold energy；Mechanical energy, such as The mechanical energy delivered by one or more cuttings and/or abrasive element；And combinations thereof.Treatment element 320 and/or 321 can match somebody with somebody Put for carrying out iontophoresis, such as irreversible iontophoresis.Treatment element 320 and/or 321 is configurable to carry out ultrasonic rush Ooze, such as irreversible phonophoresis.Treatment element 320 and/or 321 may include multiple energy delivery elements, such as multiple electrodes（Example Such as, RF electrodes）, multiple crystal（For example, ultrasonic crystal）, multiple cutting surfaces etc..The multiple energy delivery elements can be Array format, such as correspondingly below with reference to expansible the hot-bulb capsule and RF electrod-arrays described in Figure 10 and Figure 11.
Electromagnetic energy --- such as radio frequency（RF）Energy and microwave energy etc. --- can be by one or more treatment elements 320 and 321 To deliver.Electromagnetic energy can such as to be hereafter described in detail with reference to figure 4 monopolar mode or double pole mode, pass through one or more electrodes To deliver.Bipolar energy can be used for delivering to need confined energy, for example to avoid damaging non-target tissue.Bipolar skill The use of art can be reduced carries out the possibility of tissue heating in unwanted areas, or in addition prevents electric current in unexpected area Flowing in domain.Multiple energy applications can be carried out, for example handle deeper and deeper organized layer.The application of first energy, the second energy Amount application（And there may be follow-up energy application）Can have different duration or power level.First application can relate to compared with High-energy is for deeper penetrating.Second application can relate to compared with low energy, and can allow higher energy delivery spatial discrimination Rate.One of described application or all the two applications may include monopolar delivery, bipolar delivery, or the combination of both.Non-electrical It is probably preferable from radiation, but ionising radiation also can be used.
Electromagnetism transmissibility can use in microwave frequency range.When it is expected to avoid thermal conductivity so as to ablation tissue, can wrap Include the use to microwave energy.The quick of tissue and orientation can be heated to realize using microwave energy.
Ablation of tissue can be carried out using electromagnetism transmissibility（That is, tissue removes）, tissue tighten and hemostasis, the electromagnetism Transmissible scope can form tissue heating condition from the non-plasma of low-voltage（For example, cause tissue coagulation）To being capable of companion The high-voltage plasma formation condition of fly-cutting or resection organization with the minimum necrosis of non-target tissue.Can be close to target The part delivering salt solution of tissue 10, for example to cool down one or more electrodes and/or the energization by bigger electrical conductivity Delivering（For example, improve heating）.RF transmissibilities are typically to be delivered with the frequency between 100kHz to 500kHz.Non-plasma Set and occur in low voltage, generally about below 65V rms to 125V rms.
The use of plasma generation technology may include in single or one group of active electrode on radio-frequency unit tip With refurn electrode（For example, closer to end the electrode that positions or below with reference to the skin pricktest described in Fig. 4 on same device Pole）Between produce electric field.In this configuration, electric current generally flows through implantation in salt solution in place of target tissue site etc. Conducting solution.Apply usually 150V to 350V voltage between one or more point electrodes and refurn electrode.The electric field With the fluid of lower section（For example, salt solution）Interaction is createed with the molecule in exciting electrode and fluid and is referred to as plasma The high density energy field of body.Argon-arc plasma field includes high energy particle, and there is these high energy particles enough energy to break soft tissue Molecular link, so as to produce the condition that tissue is effectively dissolved under relatively lower temp.The formation of gas blanket is to cause plasma The significant process of formation condition.Gas at electrode forms the result for the electrochemical process for being electrode surface.With vapor film Formation（And there is steam layer impedance higher compared with salt solution）, the electric field across the region increased dramatically, so as to ionizing and Hydrone in broken vapor film, and form argon-arc plasma field.This processing can be applied to come with relatively low energy process to larger Tissue surface area handled.Plasma energy can be delivered by one or more treatment elements 320 and 321.
Acoustic energy --- such as ultrasound energy or secondary acoustic energy（subsonic energy）--- can be by one or more treatment elements 320 and 321 deliver.Some Vltrasonic devices（For example, ultrasound knife）Delivering available for processing.Ultrasonic component is configurable to make The heating for producing cavitation of tissue, water in pairs, to make cell expand rapidly so as to finally burst.Piezoelectric element, crystal Or other infrasonic sounds and/or ultrasonic transducer can be positioned in place of the region that need to be processed, and allow accurate energy delivery With the minimum fire damage to non-target tissue.Treatment element 320 and/or 321 can include high intensity focused ultrasound（HIFU）Delivering member Part.In such embodiment, two or more ultrasonic beams can intersect to produce converging for energy, so as to for example handle Target tissue under surface.
Luminous energy --- such as laser energy, infrared energy and/or visible luminous energy --- can be by one or more Hes for the treatment of element 320 321 deliver.Can to target tissue application reagent, and can to processing tissue delivery luminous energy.In one embodiment, reagent bag Containing the exogenous chromophore for being applied topically to target tissue.
Laser be able to can be delivered by one or more treatment elements 320 and 321.Any EM spectrums laser can be used as energy source Use.A kind of Exemplary laser is CO2Laser.CO2Laser can ensure that high water absorbing capacity, for example not expecting tissue Fire damage minimize.CO2The use of laser also can ensure that limited hemostasis, so as to avoid some submucosas from keeping not by shadow Ring and cause new mucous membrane quickly to reassemble（repopulate）.In very vascular tissue can use can be by The 532 or KTP laser that blood level absorbs（Nd:Yag laser）532NM wavelength.The short pulse of laser energy can be using blood vessel as mesh Mark, without influenceing surrounding tissue.Laser is configurable to locate by removing or otherwise influenceing the blood supply of tissue Manage tissue.Erbium can also be used:YAG or erbium:YSGG laser etc.（Optical maser wavelength is close to 2.94 microns）.These laser can provide Higher water absorption rate, and can be used with the target tissue part comprising thin or shallow section, such as several for that ought remove every time The situation in tissue resurfacing during the cell of thin layer is such.The laser of these types can also cause minimum hemostasis.Can be with Use the pulse Bladder stone of such as 2 mum lasers etc.These laser provide high water absorbing capacity.The pulse of these laser may need Substantial amounts of input energy.About 2 microns of continuous wave laser also can be used.In one embodiment, selection it is close but In water absworption peak（water peak）Optical maser wavelength, for example to provide increased thermal necrosis and increased hemostasis.
In general, it can select with the peak value in water absorption curve（It is peak value at such as 1.96 microns, 2.94 micro- Rice at peak value and 10.6 microns at peak value）Or the laser of the wavelength close to its peak value.Based on requiring, it is also possible to it is expected Ablation and necrosis（Fire damage）Combination.Can use 800nm, 980nm and between 1300nm and 2000nm it is each its He carrys out solidified structure by the diode laser of wavelength.1064nm Nd also can be used:Yag laser carrys out solidified structure.Penetration depth can Depending on selected optical maser wavelength.PRK（PRK and Lasic）, chlorination xenon and argon fluoride can be used for molecular dissociation.This A little laser can ensure that point-device tissue treatment（For example, ablation）Area to non-target tissue without causing fire damage, so as to realize Accurate cutting.These laser can help to remove endothelial layer or other organized layers, for example to promote target tissue layer from adjacent Region（For example, the adjacent area with different qualities）Rapid regeneration length.The laser of numerous types can be used, including but not It is limited to：Rear-earth-doped crystal laser；Gas laser, such as argon laser or Krypton laser；Liquid laser, such as dye laser；And its Combination.
Infrared to be delivered by treatment element 320 and/or 321, this is infrared can such as provide at desired tissue Reason, wavelength is between 700nm between 2000nm or light that these wavelength are combined.About 530nm visible ray also can be used.Such as Fruiting period hopes narrow-band, then may include non-laser source, such as generally include the xenon lamp of filter.
Reagent（Such as chemicals）And/or chemical energy can be delivered by treatment element 320 and/or 321.In structure of the present invention In some embodiments thought, chemicals can be used to remove or melt target tissue, such as duodenal mucosa or it is dry thin Born of the same parents.Such as acid, phenols and phenol/crotons（crotons）Can for example it be passed through by treatment element 320 and/or 321 Deng Chemical peeling agent The drug delivery elements such as nozzle, outlet or film deliver.Photodynamic therapy can be used（Using exposed to light and causing Learn reaction）To activate one or more reagents.Chemical reagent can be delivered to support or improve energy delivery.In an embodiment party In case, reagent includes tissue modification agent, such as puts on target tissue surface or the dyestuff being injected into target tissue or other reagents. The particular agent can be configured to be activated during energy delivery program, for example to carry out the precision ablation to tissue.For example, Chemicals can be used（For example, methylene blue）Target tissue is dyed, and then used by the energy of the chemical dye preferential absorption Source.In the present embodiment, heating is restricted, and therefore processing region can be quilt that is accurate and being limited to narrowing depth Stained tissue.Can use can be as light power or the chromophore of ultrasonic wave target.
Warm energy（Such as heat energy）Can by the sacculus filled with hydrothermal solution, cage, heated cutter can be heated（For example, surgery hand Art knife）Or heated line etc. delivers.In one embodiment, treatment element 320 and/or 321 is included and is filled with and/or can Fill the sacculus of the hot gas such as hot fluid or steam such as hot water, hot salt brine or hot glycerine.The sacculus can be configured to It is easy to meet target tissue surface.The swelling properties of sacculus allows little profile device（For example, the dress to be inserted by the chamber of endoscope Put）And among being suitable for being expanded to big chamber or other regions of such as duodenal lumen etc simultaneously.Can be by heated and/or warp Cooling fluid is incorporated into treatment element 320 and/or 321, for example to create for the addition of the change of target tissue and cold But handle.The precision of tissue treatment can be realized by Temp change method, for example include when system 300 to tissue temperature, processing What the temperature of element 320 and/or 321 and/or the temperature of the fluid delivered to treatment element 320 and/or 321 were monitored In the case of during one or more temperature sensors like that.Processing may include multiple applying heat steps, such as in similar or not equality of temperature The lower multiple steps carried out of degree.
In one embodiment, on target tissue or it is placed around magnetic-particle, and heated particle is carried out using magnetic field So as to ablation tissue.The particle can be configured to nanoparticles solution, and may include what is only expressed in Duodenal Tissues Acceptor.These particles can be selectively heated using the device for producing MRI or other magnetic fields, and thereby selectively heated Duodenum 114.Can also for example by using the MRI absorbing particles for being attached to targeting moiety, preferentially being combined with molecular target, Carried out in duodenum 14 molecular targeted.After being delivered in target tissue region or other body areas, these Grain is combined with target, and can apply MRI or other magnetic fields to heat target and peripheral cell.
Heat energy（Such as cold energy）It can be delivered by one or more treatment elements 320 and 321.In these embodiments, Using such as CO2The cold temperature sources such as source, argon source, nitrous oxide source, liquid nitrogen source handle target tissue.
Mechanical energy can be by Cutting balloon or cage；Expansible element with abrasive coating, surface treatment and/or covering （For example, with hereinafter with reference to the sacculus that net covering is denuded described in Figure 12）Etc. delivering.In one embodiment, locate Manage element 320 and/or 321 and include the polyethylene terephthalate with embedded abrasive material（PET）Sacculus.Abrasive element or mill Erosion surface can include micro- abrasive element or micro- abrasive surfaces.
It may include numerous abrasion devices and element in treatment element 320 and/or 321（For example, attrition element）.These Abrasive element can be applied to the surface of target tissue（For example, it is placed near intestinal wall）, and handled when applying rotation or translational motion Target tissue.In this application, abrasion includes the rough surface that friction is placed near intestinal wall, or scrapes blade or half along intestinal wall Pointed member.It can cut off or otherwise remove for example by ablation or previous abrasion program and through elder generation using cutting The tissue of pre-treatment.
In another embodiment, treatment element 320 and/or 321 can include high-speed fluid ejection nozzle, and such as configuration is used In delivering water, air, CO2And/or steam pulse vectored injection and be configured to handle target tissue for example to cause target Histocyte loses the nozzle of function.In this embodiment, fluid injection can physically by target tissue layer and cell from they Home position remove.
Fig. 3 system 300 does not include implanted component or device, and the body removed at the end of being only included in clinical procedure is inserted Enter device, such as in insertion 8 hours, insert in 24 hours and/or insert the device removed in one week.In alternative embodiment In, implant can be included.Implant includes but is not limited to：Support；Sleeve pipe；Drug delivery device, such as coat support, apply sheathing Pipe and/or implanted pump；And combinations thereof.
The device of present inventive concept includes structure and arranges one or more treatment elements for handling target tissue, such as Fig. 3 treatment element 320 and 321.The target tissue of selected processing may depend on one kind or more including the patient to be treated A number of factors including kind disease or illness.Patient anatomical's situation or physiological status also can to the target tissue of selection processing and/or The particular organization that should not be handled（Non-target tissue）Have an impact.The typical disease and/or illness to be treated includes but is not limited to： Diabetes, including type 1 diabetes and diabetes B；Hypercholesterolemia；Metabolic syndrome；Disease；Chylous diarrhea；It is fat；Cancer Disease, such as bronchovesicular cancer；Cystitis；And combinations thereof.Such patient anatomical's situation or physiological status include but is not limited to：High blood Sugared hyperosmotic state（It is formerly referred to as hyperosmotic nonketonic coma）；Diabetic ketoacidosis；Insulin resistance；Before diabetes Phase；Hypertriglyceridemia；And combinations thereof.
Fig. 3 A schematically illustrate the longitudinal region for the intestines and stomach that may be selected as the target tissue for processing.Can additionally or Other body parts are alternatively selected to treat one or more diseases or illness.Other body parts can be as stomach, 12 The hollow body organ of duodenum 12 and jejunum etc, and may include relatively flat（That is, non-tubular shape）Tissue surface.In a reality Apply in scheme, target tissue includes one or more sections of intestines and stomach, one or more in the following such as to treat： Diabetes；Hypercholesterolemia；Metabolic syndrome and/or disease；It is fat；And combinations thereof.Target tissue may include duodenal At least partially, for example to treat the patient with type 1 diabetes and/or diabetes B.The feature of diabetes B is to work as The insulin generative capacity function of patient it is normal or close to it is normal when insulin resistance.Blood glucose is because of the exception of duodenal mucosa Hormone generation responds like that rather than it in non-diabetic patients body.The glucose of intake can pass through alimentary canal with it And cause absorption and the signal transduction pattern of complexity in the regional of intestines.By the one or more parts for handling intestines and stomach In target tissue, it is possible to achieve be intended to reduce blood glucose and treat diabetes B treatment.Target tissue processing can change glucose Absorb and/or change the mucous membrane signal in response to glucose signals from intestinal mucosa cells and/or between intestinal mucosa cells Conduction.The processing of duodenal mucosa can reduce the insulin resistance of diabetes B patient, and improve glycemic control.
Target tissue may include terminal ileum and extend among ileum near-end and/or colon.Cholesterol and bile salt pass through The cholesterol receptors and bile acceptor being predominantly located in terminal ileum, are absorbed among body from alimentary canal.The place of terminal ileum Reason can be changed in a manner of notable from all downstream signals of the cholesterol and bile acid adsorbent in this region of intestines and change Conduction.Glucose homeostasis and cholesterol levels can be influenceed because the known cholesterol in terminal ileum and bile salt absorb, because This can be handled in the treatment to diabetes B and hypercholesterolemia using terminal ileum.Target tissue may include from generation stomach The gastric mucosa of the region of somatotropin and/or the hormone of other modulation of appetite extension, for example to treat fat and/or appetite barrier Hinder.In yet another embodiment, target tissue may include the bladder wall tissue, for example to treat interstitial cystitis, carcinoma of urinary bladder, wing Guang polyp or bladder precancerous lesion.Target tissue may include larger or flat polyp of colon or the postoperative side of polypectomy Edge tissue, for example to eliminate residual cancer cells and to improve the possibility of sufficient enough and to spare in cancer resection.Target tissue may include one The liner of individual or multiple air flues, for example to treat bronchovesicular cancer, other lung cancer or precancerous lesion.In processed air flue Lining can be substituted by the neoblast layer without pathologic lesion.Target tissue may include to suffer from such as Crohn's disease or ulcerative colitis The enteron aisle section of the inflammatory bowel diseases such as inflammation.Target tissue may include oral cavity section, to treat the precancerous lesion of carcinoma of mouth or oral cavity.Target Tissue may include pharynx nasalis, to treat nasal polyp.
Target tissue can be selected for example to treat chylous diarrhea.In chylous diarrhea, intestinal mucosa is with the fine hair being passivated and reduction Nutrient absorption ability be characterized.The processing of mucous membrane recovers the absorption function of intestines.Chylous diarrhea is also using intestinal barrier function failure as spy Sign, so as to cause intestinal wall penetrating and macromolecular is passed through space between cells, so as to trigger autoimmune response（Fasano2005）.Intestines The processing of mucous membrane improves intestinal barrier function.
As shown in Fig. 3 A embodiment, target tissue region A may include the distal portions across stomach until duodenum Proximal part longitudinal tissue part, target tissue region A includes pylorus.Target tissue region B is included across duodenal The longitudinal component of section.Target tissue region C includes the longitudinal component across duodenal distal portions.The reality of present inventive concept Applying the one side of scheme includes the selection of target tissue.The selection of target tissue is related to the gross anatomical to tissue to be dealt with And/or the consideration of functional boundary, such as consider the dissection between duodenum and adjacent intestines and stomach other components and work( Border between energy border, or 4 parts of duodenum itself.In one embodiment, selected target tissue is extremely Include duodenal whole length less.It may also include the distal portions of stomach and/or the proximal part of jejunum.In an embodiment party In case, pylorus and ligament of Treitz are handled（Duodenum-jejunum junction surface）Between tissue.
In addition to the lengthwise position of tissue to be dealt with, it is necessary to select width or the part of its circumference.In target tissue In the typical embodiments of a part including duodenum and/or jejunum, circle is carried out（For example, 360 °）Processing.Standby Select in embodiment, at least a portion receiving portion circumference of the length of target tissue（For example, less than 360 °）Processing.In a reality Apply in scheme, target tissue includes duodenal most of length, and the depth of target tissue is included along the complete of target length 360°.In another embodiment, handle close to the part-circular periphery part of ampulla hepatopancreatica, to prevent or reduce to the dissection Any damage of position.In yet another embodiment, it is adjacent or otherwise close to pancreas duodenal wall part Middle progress part-circular periphery processing, to prevent the risk of superheated and increase pancreatitis to pancreas.
Except the length of target tissue（For example, longitudinal component）And width（For example, circumferential section）Outside, it is necessary to select along length The depth of degree and width position.Depth selected by one or more is in size（For example, the millimeter of depth）On can be relatively equal Even or selected depth can be with different.Selected depth can be relevant to organization type rather than actual range, than Such as full mucous layer or submucosa or part mucous layer or submucosa organized layer thickness are such as represented without considering these The depth of holostrome or part layer actual (real) thickness.Include the typical embodiment party of a part for duodenum and/or jejunum in target tissue In case, the multiple layers or multiple layers of some of tissue are selected.In one embodiment, target tissue includes duodenum Most of length, and complete 360 ° of circumference processing comprise at least along target length all mucous layers, this include be located at crypts Including the stem cell of base portion and/or transit amplifying cells. In case, full mucous layer and submucosa（Layer 203 as shown in Figure 2）At least a portion be target tissue, such as submucosa At least 1%, at least 10%, at least 25% or at least the 50% of 203.
Selection to target tissue site, length, width and/or depth makes a choice to realize desired processing variation （Generally in tissue regions to be dealt with）.In one embodiment, processing tissue to substitute tissue with different from original The mode of beginning target tissue plays a role.Target region can be handled so that in follow-up agglutination new tissue mitigate and/or Eliminate one or more patient diseases or illness, such as the intestines and stomach in duodenum and/or duodenum proximally and distally Mitigate in partial processing and/or eliminate diabetes.Promote or realize that the regrowth of duodenal new mucosal tissue is this hair Therapeutic purpose in some embodiments of bright design.The regrowth of duodenal mucosa can cause " more healthy " or " more normal " Mucous membrane return on its original position.In other such embodiments, the regrowth of processing region can be included on side From gastric mucosa and the migration of the new mucous membrane from jejunal mucous membrane on another side（For example, due to forming from either end The stem cell of mucous membrane can retain its primary physiological status and substantially with one of gastric mucosa and jejunal mucous membrane or its mixing To substitute duodenal mucosa）.Correspondingly, in such embodiment, targeted procedures, which are related to selection, includes duodenal mucosa And until and/or adjoin region beyond duodenum junction surface and into jejunum section so as to include the region of jejunal mucous membrane To handle.The target processing region will promote the regrowth of jejunum type mucous membrane to substitute removed duodenal mucosa.Alternatively Ground, the regrowth of processing region can include the migration of the new mucous membrane of near-end and/or distal portions from duodenal mucosa（Example Such as, have due to forming the stem cell of the duodenal mucosa in these near-ends and/or distal portions than 12 handled fingers The preferred function of intestinal mucosa）.The system and method processing target tissue of present inventive concept so that the tissue that the tissue is corrected Substituted, for example to treat patient disease or illness.
For some applications, the amendment to the enteroendocrine property of tissue it is expected.Although new tissue can be such as institute above The mucosal tissue stated, but it can be alternatively fibr tissue or cicatricial tissue, or some of mucomembranous cell and other cells Heterozygote, or some other organization types as caused by agglutination.Treatment for diabetes and/or obesity, substitute Tissue with by the different types of enteroendocrine cell in new mucosal tissue amount and secretion determined, different from before processing The hormone function of tissue.Alternatively or additionally, the treatment of diabetes and/or obesity includes the replacement with different absorbent properties Tissue.Treatment for hypercholesterolemia, the tissue that substitutes in terminal ileum have by new terminal ileum mucosal tissue Absorption cell amount and type determined, absorbent properties different from before processing tissue（For example, different cholesterol absorption Rate）.
In other such embodiments, targeted procedures are related to selection and include duodenal mucosa and until and/or surpass Go out and adjoin region with the pylorus of the boundary of stomach so as to which the region including gastric mucosa is handled.Gastric pattern can be promoted by targetting the region The regrowth of mucous membrane is to substitute removed duodenal mucosa.
In other such embodiments, it may be desirable to promote the duodenal mucosa from a duodenal part Growth to substitute（In another part）Duodenal mucosa through processing.Therefore in such embodiment, targeted procedures relate to And selection include duodenal mucosa and up to and/or between duodenum each several part region is adjoined so as to wrap in border The region of the duodenal mucosa from duodenum different piece is included to handle.Any of above target-seeking situation can also be carried out Combination.
Handled target tissue may include the continuous part of tissue or the interruption part of tissue, including tissue continuous or The length of interruption, width（For example, circumferential section）Or depth（For example, layer）.Target tissue may include multiple length, multiple cross-sections Point and/or multiple depth.Target tissue can be handled in multiple steps.First treated length of handled tissue, width and/ Or depth can be overlapped in second processing length, width and/or the depth of handled tissue.First processing can be similar to or be different from Second processing, the difference being such as selected from the group：Handled target tissue region；Handled target tissue depth；Handled target Organize circumferential section；Energy delivery type；Energy delivery rate and/or amount；And combinations thereof.
In addition to handling target tissue, the treatment element or other assemblies of the system of present inventive concept can also build and arrange For avoiding handling or otherwise negatively affecting non-target tissue.Processing for intestines, non-target tissue generally include intestines Outer layer, i.e. serous coat.The non-target tissue of intestines processing generally also includes ampulla hepatopancreatica and pancreas.Non-target tissue may include muscle layer and/ Or the outermost layer of submucosa 203.The other positions of non-target tissue may include but be not limited to：Bile duct；Pylorus；One or more devices Official；And combinations thereof.
Target tissue may include that suffered processing causes the tissue for it is expected treatment benefit, unfavorable plus not having comprising processing Influence or have the safe enough and to spare of the minimum adjacent tissue adversely affected.For example, in the treatment to diabetes, duodenum （Or duodenal section）All mucous layers removal can reach desired treatment benefit without remove submucosa. However, because the processing of submucosa is with minimum adverse effect, therefore target tissue may include all or partial mucous membranes Lower floor.The layering of the penetralia of submucosa is at least used as safe enough and to spare, and is included among target tissue and ensures that entirely Mucous layer is handled.Therefore, processing accuracy required in safe enough and to spare is reduced, so as to simplify such as energy delivery The function of the treatment elements such as treatment element.In this embodiment, processing tissue deep packet includes all mucous layers plus under mucous membrane At least a portion of layer, and the length for determining（For example, at least duodenal total length）With the width of determination（For example, Along complete 360 ° of determination length）To handle the tissue of the depth.
The layer beyond submucosa such as muscle layer and serous coat can be defined as non-target tissue, because in these regions In processing can have undesirable effect（For example, enterobrosis）.Length of the selection for the target tissue of processing（For example, selected stomach The length of enteron aisle）It can be similar to the processing depth selected as described above.It is duodenal complete again for the treatment of diabetes Whole length can reach tissue of the desired treatment benefit without removing duodenum near-end or far-end.However, target tissue can Include the part of duodenum proximal tissue（That is, all or partial pyloruses）, and the part of distal duodenum tissue （That is, a part for jejunum）, for example to ensure that duodenal whole length is handled.At such complete duodenum Reason can ensure that duodenal mucosa regrowth only includes the tissue migrated from jejunum and stomach or pylorus（That is, it is not from any The tissue of untreated duodenal mucosa）.The processing parameters such as energy delivery parameters can leading along tissue to be dealt with The length adjustment of pipe, for example to adapt to different organization types and density, different wall thickness, etc..For example, distal end 12 Duodenum 12 generally has the wall thinner than near-end duodenal wall.Processing in distal duodenum can be nearer than duodenal Carried out under processing lower temperature, lower energy level in the part of end, and/or continue the shorter time.
Fig. 4 illustrates the schematic diagram for the system for being used for handling tissue according to the embodiment of present inventive concept.The quilt of system 300 Build and arrange for handling target tissue 10, including one or more tissue parts as described in reference chart 3A above.System 300 Including multifibres elongated devices 301, the device 301 includes axle 311a and 311b.Axle 311a has distal end 312.Axle 311a and 311b It is sized and is arranged so that axle 311a is slidably received by axle 311b.Axle 311a and 311b pass through endoscope 350 Service aisle（For example, 6mm service aisles）Inner chamber 351 is inserted.Axle 311a and 311b can be by all as illustrated as stretching distal end 312 Seal wire 371 and insert.Device 301 also includes two expansible tissue treatment elements：Expansible abrasive element 322a and it can expand Energy delivery elements 322b is opened, they are mounted respectively to axle 311a and 311b.Axle 311a and 311b may include one passed through Individual or multiple inner chambers, and the wire or optical fiber for being used for transmitting data and/or energy can be included.
Endoscope 350 can be standard endoscope, such as standard gastrointestinal endoscope；Either customization endoscope, is such as wrapped Include the endoscope for the sensor 353 for being configured to provide for the information related to the tissue treatment of present inventive concept.The He of sensor 353 The other sensors of system 300 can be the sensor being selected from the group：Heat sensor, such as thermocouple；Impedance transducer, such as organize Impedance transducer；Pressure sensor；Blood sensor；Optical sensor, such as optical sensor；Sonic transducer, such as supersonic sensing Device；Electromagnetic sensor, such as emf sensor；And combinations thereof.Sensor 353 is configurable to one or more to system 300 Individual component provides information, for example to monitor the processing of target tissue 10 and/or processing target tissue 10 in a closed loop manner.Endoscope 350 may include camera 352, such as by 300 operator such as endoscope 350 and/or axle 311a and 311b insertion or shifting Except before processing of the period to target tissue 10, among or visible ray, ultrasonic wave and/or other visualization devices for using afterwards. Camera 352 can provide the direct visualizztion to the internal space such as intestines and stomach internal or tissue.Endoscope 350 can couple To or otherwise include seal wire, for example to allow insertion of the endoscope 350 into jejunum.
System 300 is configurable to perform the injection to body cavity.Body cavity can be noted for example by using one or more standards Enter technology and/or pressurizeed below with reference to the technology described in Fig. 5, Fig. 8 A and Fig. 8 B.Injection fluid can pass through endoscope 350 inner chamber 354 introduces.Inner chamber 354 is proximally advanced and is connected to injection liquid or gas source, the source are not shown, but generally For air-source, CO2Source and/or water source.Alternatively or additionally, inject fluid can such as by axle 311a and/or 311b, or By the port in treatment element 322a and/or 322b, or by being not shown but being fluidly attached to also unshowned injection liquid The port of body or gas source, delivered by device 301.Alternatively or additionally, endoscope 350 is configured to insert or determine Specific installation positioned at the side of endoscope 350 can have the inner chamber that one or more is configured to delivering injection fluid.System 300 May include one or more blocking elements or device, such as expansible treatment element 322a or be not shown but be configured to radially Expansion so as to another distensible devices of for example completely or partially inaccessible body cavity, so as to reaching over time and/or Keep injection pressure（For example, reduce or prevent undesirable injection fluid migration）.One or more of blocking elements or dress Put the near-end that can be positioned on the chamber section to be injected and/or distal end.
The treatment element --- such as Fig. 4 treatment element 322a and/or 322b --- of present inventive concept, which can have, to be fixed Diameter, or they can be distensible.Expansible element can include balloon-expandable, expansible cage, can radial development Arm etc..Treatment element may include energy delivery elements or element arrays, such as be attached to the electrod-array of expandable cage.Energy is passed Element is sent to be configurable to deliver such as the various forms of energy of one or more described in reference diagram 3 above.Energy can be with constant Or the amount of change or other energy levels deliver.Energy can be continuous or pulse, and can be with closed loop Delivering.Energy delivery can change from the first tissue position to minor microstructure position, such as when second processing position is than the first processing Reduced when position is thinner from the first processing position to the energy of second processing position.Alternatively or additionally, energy delivery can be such as It is described in detail like that below with reference to Fig. 8 A and Fig. 8 B, such as by adjusting the amount of delivered energy, or is passed by mobile energy A part for element is sent, and is changed during to the single application of single organization position.
Treatment element 322a and/or 322b are configurable to cause the complete or partial destruction of target tissue, and such as 12 refer to The complete or partial destruction of intestinal mucosa.Treatment element 322a and/or 322b are configurable to remove previously processed and/or not located The tissue of reason.It can set and/or change the pressure kept in treatment element 322a and/or 322b ongoing to adjust Processing, so as to for example：Adjust the depth of processing；Adjust the power applied by abrasion device；Regulation is in the RF energy delivery phases Between the amount of energy that is applied（For example, contacted by changing tissue impedance or electrode）；And combinations thereof.
Treatment element 322a and 322b can include sensor 316a and 316b respectively.Sensor 316a and 316b can be respectively One or more sensors as described above.Sensor 316a can be configured to provide for being carried out with abrasive element 322a The related information of tissue treatment sensor, be such as attached to abrasive element 322a visible sensor, the visualization passes Sensor is configured to distinguish the organization type close to abrasive element 322a, for example to distinguish mucosal tissue and submucous tissue. Sensor 316b can be the biography for being configured to provide for the information related to the tissue treatment that energy delivery elements 322b is carried out Sensor, such as it is attached to energy delivery elements 322b and is configured to monitor energy delivery elements 322b and/or close to energy The temperature sensor of the temperature of delivery elements 322b tissue.
Energy delivery unit（EDU）330 are configurable to deliver such as the energy of one or more forms described in reference diagram 3 above Amount.In one embodiment, EDU330 is configured at least deliver radio frequency（EF）Can, and system 300 includes ground mat 332, the ground mat 332 is configured to be attached to patient（For example, it is attached on the back of patient）So that RF energy can be with list Pole modes of delivery is delivered.Alternatively or additionally, EDU330 is configurable to bipolar RF pattern delivery energy, such as Element 322b is arranged to deliver RF energy and/or system 300 including being not shown but generally including one or more electricity Situation during the second energy delivery elements of pole or conductive surface is such.
System 300 may include controller 360, and the controller 360 generally includes graphic user interface, the graphic user interface It is not shown but is configured to one or more operators execution one or more functions of permission system 300, such as one or more The typing of individual system input parameter and the visualization of one or more system output parameters and/or record.Typical system is defeated Enter parameter to include but is not limited to：The type for the energy that will be delivered, such as radio frequency energy, heat energy and/or mechanical energy；The energy that will be delivered The amount of amount, the accumulation joule number for the energy that will such as deliver or the peak volume for the energy that will be delivered；The energy bins that will be delivered The type and level of conjunction；The energy delivery duration；The pulsewidth modulation percentage of the energy delivered；Abrasion device crosses past Number is moved again；The temperature for the treatment of element, such as target temperature or maximum temperature；Inject pressure；Inject the duration；And combinations thereof. System input parameter may include the information based on patient anatomy or situation, the preoperative or peri-operation period ginseng being such as selected from the group Number：Mucous membrane density and/or thickness；The mucous membrane " carrying " of submucosa after submucosal injections from（lift off）；Target tissue Lengthwise position in intestines and stomach；And combinations thereof.Typical system output parameter includes but is not limited to：Temperature information, such as organize And/or treatment element temperature information；Pressure information, such as balloon pressure information or injection pressure information；The information of power, as applied to The horizontal information of structural power；Patient information, such as by one or more sensor records patient physiologic information；And its group Close.
One or more other assemblies of controller 360 and/or system 300 may include electronic module, such as include processor, Electronic module including memory, software etc..Controller 360 is generally configured to allow each group by system 300 of operator Part --- such as passing through controller energy delivery unit 330 --- starts, changes and stopped the processing to tissue.Controller 360 are configurable to adjust the pressure in expansible treatment element 322a and/or 322b, and target is applied to for example to change respectively The abrasive force and/or energy of tissue.Controller 360 is configurable to start to inject and/or adjust injection pressure.Controller 360 It is configurable at for example by the modification of signal one or more tissue based on one or more sensors from system 300 Parameter is managed, and delivers energy in a closed loop manner（For example, deliver energy from EDU330）Or other tissue treatments.Controller 360 can To be programmable, set for example to allow operator to store reservation system for using in the future.
Controller 360 and EDU330 are configurable to configure with constant, change, continuous and interruption energy delivery To deliver energy.Pulsewidth modulation and/or time division multiplexing can be incorporated to（TDM）To realize the precision of energy delivery, so as to for example true Protect the ablation to target tissue while keeping non-target tissue intact.
System 300 may include to be configured to the mechanism for applying motion to treatment element 322a and/or 322b, and such as motion is transmitted Element 355.Motion transfer element 335 be configurable to rotation and/or axially translation shaft 311a and/or 311b to make processing Element 322a and/or 322b are correspondingly by rotationally and/or translationally.Motion transfer element 355 is configurable to independently or unanimously Ground rotation processing element 322a and 322b.Motion transfer element 335 may include one or more rotations or linear drives assembly, Axle 311a and/or 311b driving group is operably coupled to including rotation motor, magnetic and other linear actuators etc. Piece installing.Axle 311a and/or 311b are built into enough fracture strengths and/or moment of torsion hereditary property, fully to exist Correspondingly rotationally and/or translationally treatment element 322a and/or 322b during the tissue treatment of association.Motion transfer element 335 can Communicate with controller 360, for example to activate, adjust and/or otherwise control motion transfer element 335, and thereby control Abrasive element 322a and/or energy delivery elements 322b processed motion.Motion transfer element 335 can manual drive and/or automatic （For example, motor）Driving.
In one embodiment, after the remote location that abrasive element 322a is positioned in intestines, with constant rate of speed It is simultaneously retracted fixed range by rotation abrasive element 322a with constant rate of speed, includes substantially uniform amount of tissue so as to be formed The helical trajectory denuded from intestinal wall.Alternatively, abrasive element 322a is rotatably, longitudinally or the two is in combination solid Shaken on set a distance so that abrasive element 322a is in the fixing process cycle（For example, time, pressure etc.）In denude intestinal wall repeatedly Characterizing portion.In another embodiment, controller 360 includes simple handle, and the handle is repeatedly moved back by user Move to influence the abrasion back and forth to cavity wall.Controller 360 can be included manually and motorization feature simultaneously, so as to allow user's energy Enough some parts to intestines apply motorization process cycle（For example, with set time and/or pressure）And other intestines regions are applied Add the manual handle cycle.Controller 360 can be programmable, so as to for example to realize that circumference is ground in some parts of intestines Erosion, and a part for circumference is only denuded in the other parts of the intestines such as ampulla hepatopancreatica.
Controller 360 is configurable to control energy delivery, such as energy delivery to energy delivery elements 322b.Citing For, if abrasive element 322b is RF electrod-arrays, and energy delivery unit 330 includes RF makers, then can be to control Device 360 is programmed to limit the RF energy that specified quantitative is provided in the period.In another example, if energy delivery elements 322b is to add The salt solution sacculus of heat, then controller 360 can be arranged to such as by unshowned energy transfer tube, with desired temperature and The salt solution of heating is provided and withdrawn to energy delivery elements 22b within the desired period.Controller 369 is configurable to control manually System, so that operator is first begin to energy delivery, then allow energy delivery elements 322b ablation tissues within certain period, Operator terminates energy delivery after this.
System 300 may also include one or more imaging devices, such as imaging device 370.Imaging device 370 can be configured to slotting Enter to patient's body, and be such as integrated into, be attached to, be included in and/or can include during close to axle 311a and/or 311b Visible Light Camera；Ultrasonic imaging device；Optical coherence domain reflectometry measurement（OCDR）Imager；And/or optical coherence tomography （OCT）Imager.Imaging device 370 can pass through the passage that works independently of endoscope 350（Inner chamber is not shown）Insertion.In a reality Apply in scheme, imaging device 370 is the ultrasonic transducer for being connected to axle, and it is not shown but is surrounded and generally revolved by axle 311a Turn and/or translate to create the multidimensional image in the region for surrounding imaging device 370.Alternatively or additionally, imaging device 370 It can be at outside patient body, such as the imaging device to be selected from the group：X-ray；Fluorescope；Ultrasonoscopy；MRI；PET is swept Retouch instrument；And combinations thereof.
System 300 may also include protective cap 380, and the protective cap 380 is configured to be positioned adjacent in place of tissue to prevent Damage during energy delivery or other tissue treatment events to some tissues.It is described in detail below with reference to Figure 18, protective cap 380 It is suitably adapted for endoscope 350 or another elongated devices so that cap 380 can be placed thereon and then be positioned to protect liver pancreas Pipe ampulla.In a typical implementation, such as by being removed during the program after target tissue is handled, and placing 24 hours Interior removal protective cap 380.
System 300 may also include the tissue distention device 390 for being configured to expand target tissue region, figure as will be detailed later 13 tissue distention device 390.Due to the size increase of target（Such as depth increase）It will not cause notable bad thing with processing The associated safety area of part（For example, the submucosa of mucous layer ablation）, tissue expander can greatly reduce to processing accuracy if The needs of amount delivering precision.
System 300 may also include one or more medicines or other reagents 500, be such as configured to entire patient and/or The medicament of local delivery.These medicaments can in the preoperative, all average of operation periods and/or postoperative delivering.Medicament may be configured to improve Healing, the medicament being such as selected from the group：Antibiotic, steroids, mucomembranous cell protective agent such as ulcerlmin, proton pump inhibitor or other Sour blocking agent；And combinations thereof.As the replacement of these medicaments or in addition to these medicaments, can use preoperative and/or postoperative Diet.Preoperative diet may include the food intake of low-carb and/or low-calorie.Postoperative may include comprising total stream The food intake of matter diet or low-calorie and/or low carbohydrate diet.
In a typical embodiment, system 300 does not include the component or device being chronically implanted, only in clinical journey At the end of sequence or thereafter the device in insertion body removed soon, such as in insertion 8 hours, in insertion 24 hours and/or insert The device removed in one week.In an alternative embodiment, implant 510 can be included.Implant 510 can include following It is one or more：Support；Sleeve pipe；Drug delivery device, such as coat support, coating sleeve pipe and/or implanted pump.
Each component of system 300 can be detachably attached to another component, and particularly controller 360, energy is passed Send unit 330, motion transfer element 335, ground mat 332 and endoscope 350 and elongated devices 301.
Fig. 5 illustrates the embodiment according to present inventive concept, the flow chart of the method for handling tissue.Step 410 A kind of processing target tissue such as Duodenal Tissues or other tissues are described to 413 to treat the disease of patient or illness such as glycosuria The method of disease.In the specific embodiment, target tissue includes multiple tissue parts.The multiple tissue part can include more Individual adjacent tissue regions, such as multiple circumferential sectors adjoined of duodenum or other gastrointestinal cavities.To first group of tissue part Apply the first processing, apply second processing then to second group of tissue part.First group of tissue part generally includes second group of group Knit all or part of part.First and/or second processing can handle one or more tissue regions to overlap each other（Example Such as, the border overlay of tissue part is to prevent there is undressed tissue location between the region through processing）.
In step 410, for example, the device by being previously inserted into inner chamber, such as by the inner chamber of endoscope, by elongated dress Put and be inserted into patient's body.Elongated devices are may be inserted into, for example to handle Duodenal Tissues, such as pass through stomach using through esophagus Entrance；Pass through jejunum；Pass through stomach via celioscopy instrument；Operation passes through side intestinal wall；In identical or different program Simultaneously or sequentially pass through stomach and jejunum from every one end；And combinations thereof.Elongated devices can be endoscope；It can be inserted through endoscope Enter；Laparoscopic port can be passed through to insert；Stomach port or pipe can be passed through to insert；And combinations thereof.
In step 411, target tissue and/or close to target tissue tissue, as target tissue either side on tissue, such as By the elongated devices placed in step 410, it can position, tensioning or otherwise receive operation.Operation is included but not It is limited to：Axially aligning, such as duodenum or the aligning of other intestinal tissues；Tensioning, such as axially and/or radially tensioning；Thickness is expanded, The fluid entered as noted（Such as the liquid or gas injected）Expansion to the submucosa of intestines；Apply axial force to tissue； Apply axially opposite power to tissue；Apply radial load to tissue；Urging tissue, such as oppress duodenal fine hair；Induction office Sex-limited oedema or angioedema；Radial dilatation duodenum, for example to reduce the projection of valvulae conniventes and to prevent or reduce To the undertreatment of these pleats caused by treatment element folds pleat；And combinations thereof.Tissue can be operated, To cause following one or more generations：The aligning of the length of tubular tissue；The compression of organized layer；Chamber of the projection to tubular tissue Interior compression（Such as compression of the fine hair to enteral）；The tensioning of tissue；The expansion of one or more organized layers；Increase the whole of intestinal wall Body thickness；Mucus and intestinal contents are removed from tissue wall；And combinations thereof.
Tissue operation can be completed in a variety of ways.As reference picture 8A and 8B are described in detail, tissue tensioning can pass through Applying power on contact device such as one or more expansible elements is organized in one or more and is realized.In an embodiment In, apply relative power to two tissue manipulators being positioned in body cavity in such as duodenum or other gastrointestinal cavities.Tissue behaviour Work can be carried out by injection, such as when distal expanding element closes body cavity, and pressure is injected to close to expansion member Tissue apply aligning and other operating physical forces.Injection fluid can be introduced by one or more devices, be included but is not limited to The tissue treatment apparatus and endoscope of present inventive concept.In one embodiment, apply extremely using to duodenum inner chamber Few 0.5cm H2O pressure.In another embodiment, apply to duodenal inner chamber and be less than 15.0cm H2O pressure. It is described in detail referring below to Figure 13, tissue operation can be such as placed in submucous tissue by introducing fluid into tissue through pin Fluid carry out.
The inner chamber of intestines and stomach is expanded using injection, for example more easily to be visualized to mucous membrane, is easy to such as The propulsion of the devices such as the processing unit of endoscope and present inventive concept and/or retraction, and more easily operation and/or treatment group Knit.Injection can be used as fluid such as air, CO2And/or water delivers, and it can introduce, remove and be re-introduced into, such as again After positioning one or more devices.Pleat and other tissue plications in gastrointestinal cavity be present, this may make one or more processing Placement of the element to target tissue complicates.Injection method for example can reduce or eliminate these tissue pleats by the expansion of mucosal lining The major part of wrinkle.Injection method may also be used for extending and/or stretch a part for body cavity, such as duodenum.
In step 412, the first processing is applied to multiple tissue parts order.First processing can be by drawing in step 410 The elongated devices that enter or the device of another insertion apply.First processing can include one or more processing, such as such as radio frequency Can, the application of the energy of heat energy, or another tissue treatment.
In step 413, to multiple tissue parts, typically the identical tissue part in step 412 processing, sequentially apply Add second processing.Second processing can by using come in step 411 to tissue operated device, step 412 first Processing unit or another processing unit apply.Second processing can be similar or different to the first processing.Difference is included but not It is limited to：For providing the device of processing；The type of the energy delivered；The amount or level of the energy delivered, as power level, The duration that temperature levels, energy apply；The type and level of the combination of the energy delivered；And combinations thereof.In step 413 Before or during, it can carry out minor microstructure operating procedure, such as the different tissues operations in same tissue regions, or Similar or different tissue operation in different tissue regions.In some embodiments, ground using ablation of tissue and tissue The combination of erosion.Abrasion can be closelyed follow in ablation, for example, for carrying out debridement to the tissue of ablation.Can be surplus after fine hair abrasion The ablation of remaining mucous membrane.Can in one or more tissue parts using abrasion and/or ablation be applied multiple times, until to whole The processing of target region is completed.
After step 413 end, tissue treatment can be completed, or can carry out extra tissue treatment.It can repeat Step 412 and/or 413 tissue treatment are carried out, or different tissue treatments can be carried out.In any extra tissue treatment Before step and/or period, another tissue handling steps 411 can be carried out.
One or more extra clinical procedures can be included in the method for present inventive concept.Typical auxiliary and/or Supportive program includes but is not limited to：Mucosa transplantation；Natural hole operation on mouth；Mucous membrane cicatrization program；Antibiotherapy；Configuration For preventing or promoting the medicinal treatment of mucosal tissue regrowth；Implant, such as it is configured to cause cicatrization or limitation logical Cross the physical barriers of the absorption of mucosal tissue；Treat the therapy of obesity and/or diabetes；Diet；Take exercise；And combinations thereof.
Step 412 and 413 is such as carried out generally in single clinical procedure during single sterile procedure.Alternatively Or additionally, it can be reprocessed after a couple of days, several weeks or several months.In one embodiment, handled target tissue Include the stem cell of duodenal mucosa Crypt base.In this embodiment, mucous membrane will not the elongated segment of regrowth one time, And can repeat that the secondary program of these stem cells is similarly processed according to necessary frequency, for example to provide diabetic Lasting effect.
Fig. 6 illustrates the embodiment according to present inventive concept, the flow chart of the method for handling tissue.Step 410 A kind of processing target tissue such as Duodenal Tissues or other tissues are described to 424 to treat the disease of patient or illness such as glycosuria The method of disease.Target tissue includes multiple tissue parts, and these tissue parts are handled each via first, then carried out Second processing, duodenal first section is such as handled, then handle duodenal second section.Multiple tissue parts can be with Include multiple adjacent tissue regions, such as duodenal multiple circumferential sectors adjoined.First and/or second processing can locate The one or more tissue regions to overlap each other of reason（For example, the border overlay of tissue part is to prevent between the region through processing There is undressed tissue location）.The processing in multiple regions can be such as heavy by repositioning one or more treatment elements New definition one or more delivers the expansible structure such as sacculus of energy and realized.Alternatively or additionally, can position to expand Device and axial translation treatment element are so as to continuously or piecewise handles multiple regions.First and second processing may include pair The processing of two full circumferences sections of conduit.Or first and second processing may include Part I circumferential sectors（For example, Conduit section is less than 360 °）, followed by Part II circumferential sectors, such as the remaining circumferential section of conduit.
In step 410, for example, the device by being previously inserted into inner chamber, such as by the inner chamber of endoscope, by elongated dress Put and be inserted into patient's body.
In step 411, as reference picture 5 is to described by step 411 above, target tissue and/or close to target tissue Tissue, as target tissue either side on tissue, operation can be received.
In step 421, apply the first processing to the first tissue part.First processing can be by introducing in step 410 Elongated devices or the device of another insertion apply.First processing can include one or more processing, such as such as radio frequency energy The application of energy, or another processing described herein.
In step 422, second processing is applied to the first tissue part.Second processing can be by using coming in step 411 Device, the first processing unit of step 421 or another processing unit organizing to be operated are applied.Second processing can be with class It is similar to or different from the first processing.Difference includes but is not limited to：For providing the device of processing；The type of the energy delivered； The value of energy delivery amount, such as energy level, temperature levels and the duration of application；The combination of the energy delivered；And its group Close.
In step 423, apply the first processing to minor microstructure part.The processing is generally similar to the processing of step 421, But can change, such as because the first tissue part and minor microstructure part have different tissue characteristics（Such as pending group The thickness knitted）And the energy delivery changed.
In step 424, second processing is applied to minor microstructure part.The processing is generally similar to the processing of step 422, But can change, such as because the first tissue part and minor microstructure part have different tissue characteristics（Such as pending group The thickness knitted）And the energy delivery changed.
In the case where not departing from the spirit and scope of present inventive concept, the multiple combinations of tissue treatment mode can be used With different orders.Processing mode includes but is not limited to：The type of used energy；The depth of processing；Handled tissue Surface region, include the length and/or width of tissue surface area；The duration of processing；Referring below to described in Figure 13, Such as pass through tensioning equipment or submucosal injections, the operation of the tissue to target tissue and close to target tissue；And combinations thereof.At one In embodiment, processing includes：Submucosal injections；The expansion of target tissue region near-end and/or one or more sacculus of distal end, For example to create the sealing of relative fluid seal；The abrasion of tissue；And the ablation of tissue.In another embodiment, locate Reason includes：Pass through the ablation of hot fluid sacculus；The ablation directly contacted with target tissue by hot fluid；Filled by radio frequency transmissibility The ablation put；The machinery removal of tissue, such as by denuding device.In yet another embodiment, one or more tissue operation steps Suddenly（Such as submucosal injections or the target tissue tensioning via one or more sacculus）Removed with combining mechanical tissue（Such as grind Erosion）Energy delivery（For example, the ablation using hot fluid or radio frequency energy）Combination is carried out.Energy delivery and machine can be repeated Alignment between the removal of tool tissue, vice versa.It can include in any combination and with random order at these and other tissues Manage each in step.
Before or during each in step 422,423 and 424, one or more extra tissue behaviour can be carried out Make step, such as the different tissues operations in same tissue regions, or similar in different tissue regions or not phase As organize operation.
After step 424 end, tissue treatment can be completed, or can carry out extra tissue treatment.It can repeat Step 421 and 422 tissue treatment are carried out, or different tissue treatments can be carried out.In any extra tissue treatment step Before rapid and/or period, another tissue handling steps 411 can be carried out.
Fig. 7 illustrates the embodiment according to present inventive concept, the flow chart of the method for handling tissue.Step 510 A kind of processing target tissue such as Duodenal Tissues or other tissues are described to 540 to treat the disease of patient or illness such as glycosuria The method of disease.Target tissue can include multiple tissue parts, and these tissue parts are configured to locate with one or more types The tissue treatment of reason target tissue is handled.This method includes monitoring one or more parameters and based on one or more parameters By tissue treatment adjustment within the acceptable limits, as in predetermined limit.
In step 510, the processing to a part for tissue is started.The tissue, which is generally used, includes one or more processing elements The device of part is handled.Treatment element can deliver energy（Such as RF or heat energy）, or be configurable to allow operator to deliver Energy（Such as the mechanical energy by reciprocating abrasion device transmission）.
In step 520, one or more parameters are measured with the continuation of processing, and by itself and one or more threshold values Such as one or more quantitative values are compared.
If the parameter measured within the acceptable limits, does not perform step 525, wherein the one or more processing of regulation Parameter.Adjustable processing parameter includes but is not limited to：The type for the energy that will be delivered, such as radio frequency energy, heat energy and/or machinery Energy；The amount for the energy that will be delivered, the accumulation joule number for the energy that will such as deliver or the peak volume for the energy that will be delivered；Will The type and level of the energy to be delivered combination；The energy delivery duration；The pulsewidth modulation percentage of the energy delivered；Mill The reciprocating motion number that erosion device crosses；The temperature for the treatment of element, such as target temperature or maximum temperature；Combinations thereof；And its group Close.After regulation, continue the monitoring of step 520.
If the parameter measured in acceptable restriction, performs step 530, wherein for example passing through present inventive concept The algorithm of system checks the performance of the tissue treatment of this tissue part.In one embodiment, performance inspection is Based on time or action.Time-based inspection simply can reach time limit regular time（For example, open loop） Afterwards, such as after time limit set time of one or more energy deliveries for handling target tissue, instruction is completed.Based on action Inspection can be selected from：Reach energy level；Reach power level；Energy level is delivered（For example, predetermined radio frequency energy Joule number）；The mechanical cycles of certain amount are reached, such as one group of reciprocating motion；Tissue change is had occurred and that, is such as had occurred and that Color change, quality change or other visible changes；The change of tissue impedance and/or tissue impedance has reached threshold value；Temperature And/or the change of temperature（Such as the change of temperature and/or tissue temperature）Threshold value is reached；The change of blood flow and/or blood flow Threshold value is reached；The change of hormone serum level and/or hormone serum level has reached threshold value；Blood sugar level and/or blood glucose Horizontal change has reached threshold value；Connective tissue exposes under mucous membrane（For example, pass through range estimation or chemistry and/or Biological Detection What mechanism was detected）；And combinations thereof.In step 520, such as by using one or more sensors one or more systems are measured System or patient parameter, can carry out the closed loop inspection of diversified forms.Sensor with monitoring system parameter and can provide relevant information, As discussed above concerning the sensor listed by Fig. 4.The sensor of present inventive concept can be placed on one or more positions, generally fixed Position is in patient's body.Sensor can be positioned in body cavity, as on the device placed in duodenum so that the sensor contacts ten Two duodenum 12 walls.Alternatively or additionally, after submucosal injections occur, one or more sensors can be placed on tissue wall It is interior, as under mucous membrane in gap.Alternatively or additionally, the sensor can be positioned at parenteral, such as in parenteral gap or week In closed structure.In one embodiment, sensor is positioned at or close to ampulla hepatopancreatica, for example to monitor the temperature of pancreas Degree.In another embodiment, sensor is placed to monitor blood vessel structure venacaval temperature as follows.Sensor can monitor With the information for providing the parameter being such as selected from the group on patient parameter：Temperature information, such as tissue temperature information or treatment element temperature Degree；Impedance information, such as tissue impedance's information；Pressure information；Blood flow information；Blood sugar level；Insulin level；Hyperglycemic factor water It is flat；GIP, GLP-1, GLP-2 and/or other gastrointestinal hormones are horizontal；And combinations thereof.In one embodiment, including heat and/or Impedance transducer, and utilize sensor information regulation energy delivery such as radio frequency transmissibility.
If the processing of this tissue part has been completed, step 540 is performed, wherein repositioning one or more tissues Processing unit is to handle the extra tissue part of target tissue, repeat step 510 afterwards.If whole tissue part everywhere Reason, then tissue treatment is completed, and can remove one or more devices from patient, or for performing secondary program.
In step 510 before startup processing, one or more parameters can be measured, such as one or more systems or patient Parameter.In one embodiment, organizational parameter is measured, such as with visible sensor or device as utilized ultrasonic wave, optics phase Dry domain reflectometry measurement（OCDR）And/or optical coherence tomography（OCT）Visible sensor or device measured by group Knit thickness.Based on the result of before processing parameter measurement, one or more processing can be adjusted, such as based on the particular organization position measured The energy that will be delivered is improved or reduced in the tissue thickness put.Before or during one or more follow-up tissue treatment steps, The one or more parameters measured before tissue treatment can measure again（For example, continuously or intermittently monitoring in real time）.Another In one embodiment, measurement parameter（Such as the organizational parameter measured by imaging sensor or device）To select processing side Formula.Typical processing mode includes but is not limited to：The kind of energy that will be delivered；The selection of tissue treatment parameter, with allow or Prevent the regrowth of one or more cell types.
It can carry out and monitor processing, until causing substantial amounts of mucomembranous cell or from crypts and fine hair, generation hormone Cell non-functional.Processing monitoring may include for example in radio frequency transmissibility or other ablation tissue processing procedures, at monitoring The penetration depth of reason.In the one side of present inventive concept, the cell of non-functional is irreproducible, that is, substantially eliminates idle The regrowth and regeneration of energy property cell.Being changed into the cell of non-functional may include a part for mucomembranous cell, as less than 100% Mucomembranous cell.In another embodiment, being changed into the cell of non-functional includes all mucomembranous cells（I.e. 100% mucous membrane Cell）.In this embodiment, can be directed to（Even if its non-functional）A part for cell under mucous membrane, it is all viscous to ensure Theca cell is all affected.In another embodiment, such as the tissue treatments of ablation steps can be directed to the dry of Crypt base Cell.The removal of these specific stem cells can prevent the regrowth of mucous membrane stem cell.Similar or dissimilar energy can be carried out Measure the multiple ablation of delivering.In yet another embodiment, by melting surface mucosa and intestinal villus, shaving or mechanical damage tissue To eliminate killed cell, then melting mucomembranous surface again can be extended with the stem cell for Crypt base, tissue treatment To stem cell levels.There is provided on target tissue and being described in detail in for non-target tissue above with reference to Fig. 3 A.
Monitoring to one or more systems or patient parameter such as tissue thickness and/or tissue treatment penetration depth can be used To reduce or minimize narrow formation, bleeding, cicatrization and/or perforation.In one embodiment, if detected routed Ulcer, cancer and/or parenchymal tissue positioning, then can stop or otherwise change tissue treatment.Tissue treatment penetration depth It can be monitored with one or more system sensors, such as vision sensor, as ultrasonic sensor or other eucaryotic cell structures pass Sensor；Impedance transducer, such as tissue impedance's sensor, and/or the sensor that other may be related to depth information.Penetration depth It can monitor in real time, or the delay monitoring with minimum, for example to prevent the undesirable clinical events being selected from the group：Prevent not Desired narrow or cicatrization；Perforation；Bleeding；And combinations thereof.The penetration depth information obtained with one or more sensors Can be used for automatically processing tissue or be simply supplied to clinician or other systems operator, to be explained to it and Then processing is adjusted.
Many patients and/or systematic parameter can be carried out before, during or after one or more tissue treatment steps Measurement, for example, being measured by using the sensing device of one or more sensors or the system of present inventive concept.It can make With myoelectric sensor, for example, for carrying out the electromyography of muscular layer of mucosa.Clinician can sense muscularize's mucous membrane Shrink as a kind of mode for realizing appropriate processing depth.By measuring the change of the impedance to the electric current that is delivered to tissue, Penetration depth can be controlled.When impedance from can to value changes expected from mucous membrane for can to expected from muscular layer of mucosa or submucosa value When, reduce or stop energy delivery.It may be inserted into and be configured to monitor the electricity of muscular layer of mucosa or the probe of contraction movement, so as to example Such as assess influence of the energy delivery to muscle function.Quantitative calorimetry can be utilized to monitor the change of tissue or tissue characteristics, such as Tissue characteristics are monitored before, during and/or after tissue treatment, as already mentioned above.Can configure one or Multiple sensors or sensing device, to provide serum analysis, as hormone discharges data or glucose responding data.
One or more systems or patient parameter can be measured using one or more vision sensors or device.Such as In ablation procedure, it can be detected using the vision of mucous membrane to control the depth of energy delivery.Carried out using light scattering analytical method Tissue surface is evaluated, such as determines depauperation or evaluation fine hair characteristic, such as length or color.Because fine hair is generally than mucous membrane face Color is more shallow, and the progress of processing is monitored using spectroscopic methodology（For example, the removal of fine hair）.The sign of tissue color change can determine Organize dry level（Such as redden or bleach）.Oedema, the identification of perfused tissue and/or tissue oxygenation and/or quantitatively can be with It is monitored using vision sensor or visualization device.Mucous membrane imaging can be carried out with enteroendocrine cell existing for determining Type.
The sensor and sensing device of present inventive concept can be positioned at one or more of patient body internally and/or externally Individual position.Imaging device can be used for measuring many parameters, include but is not limited to：Body temperature；The thickness and temperature of tissue；With target group Knit interior or neighbouring vascular distribution（vascularity）.In one embodiment, detected using outside imaging device in Leng Chu " ice hockey " that reason is found when being formed.A variety of imaging modes can be used, the imaging mode being such as selected from the group：X ray, it is such as glimmering X ray fluoroscopy x inspection；CT is imaged；MRI；Ultrasonic imaging；Molecular imaging；Nuclear imaging, as adjoint or being not accompanied by dextrose tolerance test Nuclear imaging；OCT；Spectrum analysis, such as trillion hertz of spectrum analyses；And combinations thereof.Imaging device can be outside, or they It can be placed in vivo, such as by via endoscope（The endoscope being such as inserted into intestines and stomach）And insert；Couple is built-in Put；Laparoscope probe；And combinations thereof.
Fig. 8 A and 8B illustrate the embodiment according to present inventive concept, before axial force is applied respectively to target tissue and Afterwards, the sectional view of the distal portion of the tissue processing system of two tissue operating elements is included.System 300 is fabricated and arranged For handling target tissue 10, including above with reference to one or more tissue parts described in Fig. 3 A.System 300 includes device 301, Device 301 is had been inserted into body cavity such as duodenum, and the body cavity includes wall W and target tissue 10, typically the 360 of intestinal tissue ° Section.Device 301 includes axle 311a, and axle 311a is slidably received by axle 311b.Be installed to axle 311a distal end is operation member Part 317a, it is typically to be configured to be operatively engaged cavity wall tissue without the balloon-expandable penetrated or expansible cage.Installation That to axle 311b distal end is operating element 317b, generally also balloon-expandable or expansible cage.In an alternative embodiment party In case, element 317a and/or 317b engagement are realized using certain tissue penetration, such as are glued via penetrating to close The projection of the depth at film-submucosa interface, for example to ensure there are enough grips when being positioned at enteral.Axle 311b can be with It is configured to slidably pass through single device, such as endoscope, operating element 317a and 317b is expanded to engage cavity wall W afterwards.
Be positioned at axle 311b interior intracavitary is treatment element 320.Treatment element 320 may be configured to by axle 311b Wall apply energy into cavity wall tissue, such as pass through apply laser or ultrasonic wave energy.In the delivering configuration of these oriented energies, place Reason element 320 can be operably coupled to energy source, such as laser or the source of ultrasonic wave energy.Treatment element 320 can include One or more energy deliveries or induction element, such as piezo-electric crystal, lens, speculum, wave filter.Alternatively or additionally, Treatment element 320 can be configured to for example by the opening in axle 311b（Opening is not shown）Radial dilatation, and contact wall W, So as to realize by processing of the contact to tissue 10, such as when treatment element 320 contains hot fluid and/or one or more During radio frequency energy delivery electrode.Alternatively or additionally, treatment element 320 may be configured to deliver by the opening in axle 311b Energy, the opening are not shown, but are typically the opening for being configured to allow for fluid to pass through injection, and fluid injection is configured to connect Touch and melt target tissue 10.
Treatment element 320 is connected to axle 329, and axle 329 can include optical fiber, fluid bearings chamber and/or one or more electricity Wire, and can be configured to rotate, for example to cause treatment element 320 to rotate, such as when energy is delivered to wall W. Alternatively or additionally, axle 329 can be configured to axially translate back and forth, for example to be moved along pending tissue regions. Rotation and/or axial translation can be realized by the motion transfer element above by reference to described in Fig. 4.Energy can be applied equably It is added on target tissue, or there may be discontinuous or otherwise uneven delivering energy.In energy can be applied to The whole circumference of chamber, such as along predetermined duodenal length.
In some applications, it is probably it is expected to carry out operation to target tissue 10 before energy or other tissue treatments are applied 's.In a typical embodiment, as shown in Figure 8 A, tissue operating element 317a and 317b expand and are positioned proximate to Target tissue 10, for example, when element 317a and 317b be positioned to by it is duodenal about 2cm to 5cm is stretched when.As shown in Figure 8 A, Wall W can include multiple folds or bent portion.In the fig. 8b, such as via one on axle 311a and/or 311b near-end or Multiple controls, axle 311a has advanced into and/or axle 311b has bounced back, and the control is not shown, but is usually incorporated into the near of device 301 In handle on end.Axle 311a propulsion and/or axle 311b retraction cause operating element 317a to target tissue 10 to institute respectively Show the page right side applying power and/or left side applying power from operating element 317b to the shown page.These power cause target tissue 10 Tensioning, for example to remove or reduce one or more of target tissue 10 fold；Stretch target tissue 10；Position target tissue 10； Support target tissue 10；And combinations thereof.Treatment element 320 can apply tensioning by operating element 317a and/or 317b（That is axle To）It is activated before, during or after power.Alternatively or additionally, can be in operating element 317a near-end（For example, element Between 317a and 317b, this forms opposing seal with cavity wall）Injection fluid is introduced, causes increasing of the cavity wall tissue due to cavity pressure Add and radial dilatation, stretch and/or otherwise operated.
The processing of target tissue 10 can include multiple tissue handling steps, such as when target tissue 10 is longer than shown in Fig. 8 A and 8B When.In these embodiments, operating element 317a and 317b can be to the first tissue section applying power, and they are radially pressed afterwards Contracting, simultaneously radial dilatation is promoted, so as to for example to minor microstructure section applying power.Tissue treatment is generally passing through operating element 317a Carry out, and multiple organizing segments can be repeated after each tensioning carried out with 317b.In certain embodiments, in axle 311a After a series of 311b propulsions, a series of retractions are carried out, also operator 317a and 317b are operated with tensioning tissue area Section simultaneously activates treatment element 320 to handle these organizing segments.
The system of present inventive concept can handle tissue in single step or multiple steps.Including tissue treatment element Device can be directed to single treatment positioning once, or multiple for repeatedly processing repositioning.Including tissue operating element Device, which can have, positions one or many one or more tissue operating elements.Tissue operation can carry out once or more It is secondary.Energy delivery or other tissue treatments can keep relative constancy in tissue treatment or in multiple processing.Or energy is passed Sending can change in tissue treatment and/or in multiple processing.
In one embodiment, Fig. 8 A and 8B tissue operating element 317a and 317b positions one in one location It is secondary, energy is applied by tissue treatment element 320 afterwards.In this embodiment, tissue treatment element 320 can not moved In the case of apply energy（For example, in primary energy delivering applies or in multiple application in same position）.Single step delivering can It can need to deliver substantial amounts of energy, such as by being configured to deliver cold energy, heat energy such as hot-fluid physical efficiency, radio frequency energy such as by more electric The tissue treatment element of the radio frequency energy of pole array delivering.Or tissue treatment element 320 can rotate and/or translate back and forth, and Also without repositioning operating element 317a and 317b（I.e. to the tissue delivery energy between element 317a and 317b）.One In individual different embodiment, tissue operating element 317a and 317b are positioned in multiple positions, and tissue treatment element 320 can To provide the energy delivery of the energy delivery of single position or multiple positions, this is completed by rotationally and/or translationally. In the motion process for the treatment of element 320, energy or other processing parameters can change or keep constant.
The motion for the treatment of element 320 is combined following one or more available for realizing with the modification of energy delivery：Change The depth of processing and/or the depth for maintaining processing；The peak energy level for delivering needs is minimized suitably to handle target group Knit；For tissue treated before the reprocessing monitoring of possible reprocessing or modification；Pending tissue is monitored to set Processing parameter such as energy level；Overlapping anatomic processing region；And combinations thereof.
Operating element 317a and/or 317b can be diversified forms, include but is not limited to：Expandable sacculus；It is expansible Cage；Extensible arm, such as can radial development arm；And combinations thereof.Tissue operating element 317a and/or 317b can configure use In occlusion or Partial occlusion inner chamber such as intestines for example in injecting program.Organize operating element 317a and/or 317b can be further It is configured to handle tissue, such as supplements or substitute tissue treatment element 320.
In one embodiment, it is sacculus or other radially distensible structures to organize operating element 317a and 317b （For example, distensible cage）, it is configured to be pressurized to the level for being enough to apply intestinal wall such as duodenal wall tractive force.Substitute Ground or additionally, operating element 317a and 317b can be configured to allow to inject cavity between element 317a and 317b Long-pending sacculus or other occlusion structures.In a typical embodiment, operating element 317a and 317b are about 2 inches to 4 The long sacculus of inch, and through operation（For example, longitudinal extension）To be configured with stratiform and/or uniform working surface to position Target tissue.
In an alternative embodiment, it can be stretched using gimlet.This stretching can relate to enteroscopy system, such as Rotate the spiral enteroscopy system into position.These systems can be used for for example when ablation or other target tissue processing units are along ten Two duodenum 12 promote or remold target tissue such as duodenum when bouncing back.
Fig. 9 illustrates the embodiment according to present inventive concept, and the sectional view of the distal portion of tissue processing system, this is System includes a distensible treatment element and two are organized operating element.System 300 builds and arranged for handling target group 10 are knitted, including as described above with one or more tissue parts described in Fig. 3 A.System 300 includes device 301, and device 301 is Through being inserted into body cavity such as duodenum or other gastrointestinal cavities, the body cavity includes wall W and target tissue 10, typically intestinal tissue 360 ° of sections.Device 301 includes axle 311a, and axle 311a is slidably received by axle 311c.Axle 311c is slidably received by axle 311b. Axle 311a and 311b include operating element 317a and 317b, and operating element 317a and 317b have the operation with Fig. 8 A and 8B respectively Construction and arrangement similar with 317b element 317a.Axle 311b can be configured to slidably by single device, such as endoscope, Operating element 317a and 317b is expanded to engage cavity wall W afterwards.Axle 311a may include inner chamber 313, and such as guidewire lumen, inner chamber 313 exists Distally axle 311 is exited at 312.
On axle 311c is ablation 322, and it includes expansible element 327, usually sacculus, as such arranged to Operationally expand to contact, oppress and/or otherwise engage cavity wall tissue W conformal or non-conformal sacculus.It is installed to In expansible element 327 is electrode 328, typically compliant conductive bar, the platinoiridita bar such as adhered in expansible element 327. Electrode 328 can be attached on energy delivery unit, and energy delivery unit is not shown, but is generally similar to Fig. 5 as described above EDU330 and configure, such as pass through one or more wires（It is not shown）.Electrode 328 may be configured to deliver monopolar radio frequency Can, such as it is delivered to ground mat electrode.Electrode 328 may be configured to deliver bipolar radio frequency energy, such as when device 301 includes list Only electrode（It is not shown）When, or when circumferential surface of the electrode 328 along expansible element 327 includes multiple segmented electrodes. System 300 can include conductive and/or thermally conductive gel, the gel and be not shown, but be configured to energy delivery and/or compensation times What heterogeneous surface, such as duodenal minute folding and intestinal villus.Or luminous energy can be delivered by expansible unit 327. In the embodiment, the gel of printing opacity can be used for improving the coupling between element 327 and target tissue.
Expansible element 327 may be configured to apply pressure to cavity wall W so that be deposited between electrode 328 and target tissue 10 In sufficient and uniform contact.The application of pressure can be carried out with " extrusion " blood, so as to reducing in pending tissue or The heat sink effect of neighbouring flowing body fluid.The pressure of application can also be attenuated（Such as oppress）Pending tissue wall so that apply The radiation transmission of the energy added is improved, and heat transfer reaches deeper organized layer.
Expansible element 327 and electrode 328 are configured so that multiple energy delivering can be carried out to handle target tissue 10. The first energy delivery is carried out afterwards and before the second energy delivery, one or more operations can be carried out, such as：Rotation electrode 328；Promote or bounce back electrode 328；Propulsion or retraction operation element 317a and/or 317b；And combinations thereof.As discussed above concerning Fig. 5, Described by 6 and/or 7, multiple energy or other tissue treatments are carried out, until target tissue 10 is fully handled.
In some applications, as being described in detail above with reference to Fig. 8 A and 8B, apply energy or other tissue treatments it It is preceding that to carry out operation to target tissue 10 be probably desired.The processing of target tissue 10 can include multiple tissue handling steps, such as When target tissue 10 is longer than shown in Fig. 9.In these embodiments, operating element 317a and 317b can apply to the first tissue section Reinforce, they are radially compressed, promote simultaneously radial dilatation afterwards, so as to for example to minor microstructure section applying power.Tissue treatment Generally carry out, and multiple organizing segments can be repeated after each tensioning carried out by operating element 317a and 317b. In some embodiments, after axle 311a and 311b a series of propulsions, carry out a series of retractions, also to operator 317a and 317b is operated with tensioning organizing segments and is activated treatment element 320 to handle these organizing segments.
Fig. 9 system 300 can be used to carry out above by reference to the energy delivery step that Fig. 8 A and 8B system 300 describe, Wherein Fig. 9 tissue operating element 317a and 317b can place one or many.Expansible element 327 and electrode 328 can be with Positioned, repositioning that is adjoint or being not accompanied by operating element 317a and 317b for single or multiple energy deliveries.Handling In any motion process of element 320, energy or other processing parameters can change or keep constant.The fortune for the treatment of element 320 It is dynamic to be combined and be used in a manner of similar to above by reference to described in Fig. 8 A and 8B with the modification of energy delivery.
Figure 10 illustrates the embodiment according to present inventive concept, and the side view of the distal portion of tissue processing system and end regard Figure, the system include the expansible treatment element comprising leafy sacculus.System 300 builds and arranged for handling target tissue, wraps Include one or more tissue parts above by reference to described in Fig. 3 A.System 300 includes device 301, and device 301 includes leafy processing Element 320.Device 301 includes axle 311, and treatment element 320 is arranged on axle 311.The blade 326 for the treatment of element 320 and axle 311 Cavity fluid connection, inner chamber is not shown, but proximally marches to the injection port being typically mounted on the handle of device 301. Axle 311 can be configured to slidably pass through single device, such as endoscope, after-treatment component 320 expand to engage target tissue, Such as cavity wall.Axle 311 may include inner chamber 313, and such as guidewire lumen, axle 311 is exited in inner chamber 313 at distal end 312.
Treatment element 320 is shown with its radial-expansion condition, and is sized to engage the wall of body cavity, such as duodenum Wall.Blade 326 builds and is arranged so that when treatment element 320 is positioned in body cavity and is expanded, single device（For example, The imaging of system 300 or processing unit）Can be through one or more blades 326.Blade 326 is typically filled with elevated The salt solution of the fluid of temperature, such as from about 65 DEG C to 90 DEG C so that target tissue can items 320 melt or otherwise locate Reason.Treatment temperature and duration can be selected so that the tissue between blade 326 is also fully handled.Or axle 311 and blade 326 can continuous energy application between rotate, so as to carry out 360 ° ablation.Treatment element 320 can be carried out Continuous spreading, with one or more positions manage target tissue.Before each tissue treatment and/or period, such as above Through description, can be operated to target tissue and/or close to the tissue of target tissue.Alternatively or additionally, blade 326 can be with Including one or more electrodes, such as it is configured to deliver the electrode of electromagnetic energy such as radio frequency energy.
Figure 11 illustrates the embodiment according to present inventive concept, a kind of side view of the distal portion of tissue processing system, The system includes the expansible treatment element comprising multi-electrode cage.System 300, which is fabricated and arranged, to be used to handle target tissue, including Above with reference to one or more tissue parts described in Fig. 3 A.System 100 includes device 301, and device 301 includes multi-electrode processing Element 320.Device 301 includes axle 311, and treatment element 320 is operably mounted on axle 311.Axle 311 is configurable to slide Ground passes through single device, such as endoscope, after-treatment component 320 expand to engage target tissue, such as cavity wall.Axle 311 may include Inner chamber 313, such as guidewire lumen, axle 311 is exited in inner chamber 313 at distal end 312.
Treatment element 320 includes cage 325, and cage 325 is shown and is sized with its radial-expansion condition to engage body cavity Wall, such as duodenal wall.Cage 325 is operably attached to one or more axiss of dilatation or cable, and the axis of dilatation or cable are not shown, But be typically configured to when by bounce back tensioning when deploy（That is radial dilatation）Cage 325, and compress when pushed（Release exhibition Open）Cage 325.Cage 325 is fabricated and is arranged so that when treatment element 320 is placed in body cavity and is expanded, single device Can be by between one or more arms of cage 325.
The electrode 324 for the treatment of element 320 is installed on cage 325, and is electrically connected to one or more wire, the wire Be not shown, but proximally advance to electrical connection, be typically mounted to the handle of device 301.Energy transmission unit（Also it is not shown, But there is similar construction with Fig. 5 EDU330）It is configured to deliver monopole and/or bipolar to one or more of electrode 324 Energy.Energy, generally radio frequency energy, electrode 324 can be delivered to so that target tissue can items 320 melt or with it He is handled mode.Energy, temperature and/or processing duration can be selected so that the tissue between electrode 324 also obtains Fully processing.It is configurable to utilize one or more energy deliveries after a positioning step to the energy delivery of electrode 324 Carry out complete circumference tissue treatment.Or axle 311 and electrode 324 can rotate between the application of continuous energy, to carry out 360 ° of ablations.The continuous spreading for the treatment of element 320 can be carried out, to manage target tissue in one or more positions.At each group Knit processing before and/or period, as described above, can operate target tissue and/or close to target tissue tissue.
Figure 12 illustrates the embodiment according to present inventive concept, a kind of side view of tissue processing system, at the tissue Reason system includes two tissue treatment elements, the netted abrading apparatus that sacculus is supported and the sacculus for being configured to accommodate hot fluid.System System 300, which builds and arranged, to be used to handle target tissue, including above with reference to one or more tissue parts described in Fig. 3 A.System 100 include device 301, and device 301 includes the first tissue treatment element 320 and minor microstructure treatment element 321.Device 301 wraps Axle 311 is included, treatment element 320 and 321 is operably mounted on axle 311.Axle 311 is configurable to slidably pass through individually Device, such as endoscope, after-treatment component 320 and 321 sequentially or simultaneously expand to engage target tissue, such as cavity wall.System 300 may include seal wire 371, and axle 311 may include inner chamber 313, and inner chamber 313 is configured to slidably receive seal wire 371, for device 301 and/or other internal insertable device such as endoscope or minor microstructure processing unit pushing away via the seal wire of system 300 Enter.
It is sized with the treatment element 320 shown in its radial-expansion condition to engage body lumen wall such as duodenal wall. Treatment element 320 includes being abraded element 322a（For example, the netted abrading apparatus with the argyle design shown in Figure 12）Surround Expansible element 327a（Such as expandable sacculus）.Abrasive element 322a may include roughened surface, and/or can be soaked with abrasion Material, such as gravel or abrasive material.Expansible element 327a is connected with the cavity fluid in axle 311, and the inner chamber is not shown, but with The inlet 303 being installed on handle 302（For example, standard Luer connectors）Fluidly connect.Such as air, CO2Or salt solution etc. Expansion fluid can be introduced by axle 311, with radial dilatation abrasive element 322a.Tissue treatment is by being connect in abrasive element 322a Touch cavity wall tissue while back and forth translation shaft 311 and/or rotary shaft 311 and complete.Can be by being applied to expansible element Radial load on 327a（Pressure i.e. in element 327a）, be applied on expansible element 327a axial force, be applied to and can expand Revolving force on element 327a and combinations thereof is opened to be adjusted to processing.
Also it is sized with the treatment element 321 shown in its radial-expansion condition to engage body lumen wall such as duodenum Wall.Treatment element 321 includes expansible element 327b（Such as expandable sacculus）, expansible element 327b is configured as filling Hot fluid 322b（For example, it is heated to about the salt solution of 65 DEG C to 90 DEG C of temperature）.Expansible element 327b and the inner chamber in axle 311 Fluidly connect, the inner chamber is not shown, but with inlet 304（For example, standard Luer connectors）Fluidly connect so that the salt of heating Water can be introduced by axle 311, so as to radial dilatation expansible element 327b and handle the target tissue close to hot fluid 322b.Group It is by being realized via heat transfers of the expansible element 327b from hot fluid 322b to tissue to knit processing.In some embodiment party In case, expansible element 327b can be moved in organization processes relative to target tissue, such as axial direction or rotary motion, so as to Heat is delivered to the tissue surface area longer than expansible element 327b.
The continuous spreading for the treatment of element 320 and 321 can be carried out, to manage target tissue in one or more positions.Every Before individual tissue treatment and/or period, as described above, target tissue and/or the tissue close to target tissue can be operated.
Figure 13 A illustrate the embodiment according to present inventive concept, the target tissue extension fixture being placed in intestines and stomach Sectional view.Endoscope 350 has been advanced to endoceliac a certain position, such as duodenum.Fluid expansion device 390 has inserted In endoscope 350, and show and therefrom exit.Extension fixture 390 includes being located adjacent to the thin of duodenal mucosa 201 Major axis 391.Display fluid 395 is exiting the inner chamber of axle 391.Axle 391 and device 390 are configured for delivering with spray mode Fluid 395, such as by using passing through nozzle, pressue device and nozzle（It is not shown）High pressure delivering.As shown in FIG. 13A, glue Film lower floor 203 has started to adjacent circumferential expansion.One or more devices of present inventive concept can be utilized, such as one or more above-mentioned dresses Put, carry out the expansion of submucosa 203, to increase the target region for handling.The target region of increase meets with preventing non-target tissue It is subject to processing（For example, ablation or abrasion）Aspect is probably favourable, the safe enough and to spare such as by expanding target tissue.
Figure 13 B illustrate the embodiment according to present inventive concept, another target tissue expansion being placed in intestines and stomach The sectional view of device.Figure 13 A device 390 ' is had been inserted into endoscope 350, and shows that it is therefrom exited.Dress 390 ' are put in form and the device 390 for being functionally similar to Figure 13 A, difference is that axle 391 ' includes the pin 392 that can be promoted. The pin 392 that can be promoted, rather than Figure 13 A water jet, it is arranged to be pierced into tissue so that fluid 395 can be delivered to Tissue is interior and expands tissue.
Figure 14 to 15 illustrates the process step 400 of the embodiment of present inventive concept, wherein handling duodenal target Region.It should be noted that the step of determining target region goes for combining each embodiment that Figure 14-16 is discussed. The program may begin at step 402.It is clear-headed such as general anesthesia or intravenously in the case where patient is in anesthetic effect in step 404 After calmness, endoscope 302 may be inserted into patient's body.Endoscope 302 can be fitted to sight glass through seal wire（scope）Existing chamber It is interior.Hereafter, in step 408, protectiveness insertion can be implemented to ampulla hepatopancreatica 118.In step 410, RF sacculus can be used 304 and Cutting balloon 308 extend and linearize duodenal mucosa.In step 412, any side can be applied in stepwise fashion The above-mentioned therapy of formula, to handle, destroy or remove tissue.In step 414, protectiveness insertion can be removed from ampulla hepatopancreatica 118. Finally, endoscope 302 can remove in step 418 from body.The program can end at step 420.According to present inventive concept An embodiment, the treatment flows of diabetes can also include the depth of monitoring processing.According to the embodiment, locator （placeholder）Endoscope 302 can be provided with.Can using can endoscopically 302 sensor that is equipped with together monitor Ablation or the depth of scraping.
According to some embodiments of present inventive concept, Sensor monitoring can also be utilized in ensuing a couple of days, several weeks Or the related physiological parameters in the several months, such as blood glucose, insulin.The above method not only can be used to treat diabetes, and available Come improve the symptom of diabetes, treatment metabolic syndrome, improve glucose tolerance, reduce patient in insulin resistance and Reduce body weight or obesity, etc..
In some embodiments of present inventive concept, method described herein attempts and realizes the hormone signal of change Conduction.Therefore, the device used according to present inventive concept embodiment can be with the hormone to being measured as effect The monitoring of signal transduction is coupled.This can be by sampling be discharged into analyze in itself to blood or lymph-space or interior chamber content Hormone in intestines and stomach is realized by some other modes.
Referring to Figure 15, an embodiment of the present inventive concept for treating diabetes B is described.The program can be with Start from step 502.In step 504, after under patient is in anesthetic effect such as general anesthesia or spinal anesthesia, endoscope 302 It may be inserted into patient's body.Hereafter, in step 508, protectiveness insertion can be implemented to ampulla hepatopancreatica 118.In step 510, RF sacculus 304 and Cutting balloon 308 can be used to extend and linearize duodenal mucosa.In step 512, can for example with by The mode of step applies energy to processing region, so as to cause the processing to duodenal mucosa.Can use can be equipped with cutting dress Duodenal mucosa of the shaving of Cutting balloon 308 through being subject to processing put.The removal of patient's duodenal mucosa can make patient 12 The remainder of duodenum 12 114 anatomically remains intact.In addition, the elimination of stem cell can be also carried out to prevent regrowth.Apply Add energy and using mechanical device come denude or cut the process of mucous membrane may include between energy and abrasion it is alternate continuous Multiple processing, or may include multiple energy steps and less abrasion, or multiple abrading steps and less energy step. Step 514, protectiveness insertion can be removed from ampulla hepatopancreatica 118.Finally, endoscope can be removed from internal in step 518 302.In step 520, the jejunal mucous membrane of patient can be promoted from the duodenal mucosa for replacing removing and existing jejunum is dry thin Intracellular growth.This promotion can be by selecting target region to realize according to the pattern C on Fig. 3 A.
It can treat diabetes using the above method and improve the symptom of diabetes, treatment metabolic syndrome, improvement Portugal Grape sugared tolerance, reduce the insulin resistance in patient and reduce body weight or obesity, etc..For appointing for any of above treatment The details of what therapeutic scheme can be with significant changes, and are still within the range of present inventive concept.
Referring to Figure 16, according to the another embodiment of present inventive concept, the treatment flow of diabetes B is described.Figure 16 The flow chart according to the 3rd embodiment is illustrated, which depict the process step 600 for the treatment of diabetes.The program can start In step 602.In step 604, the bile salt and pancreatin of the patient not contacted yet with the food that patient is taken in can be obtained. Step 608, acquired bile salt and pancreatin can be delivered to the duodenum 114 of patient.The program can end to walk Rapid 610.According to the embodiment, treatment can be based on not（With the food of intake）The bile salt and pancreatin of reaction are from ductus pancreaticus and bile duct Direct conveying to duodenum 114（routing）.Method described in the embodiment can not only be used for treating diabetes, And it can be used for improving the insulin resistance in the symptom of diabetes, treatment metabolic syndrome, improvement glucose, reduction patient And reduce body weight or obesity, etc..Various modifications can be carried out to the program, and be still within present inventive concept scope it It is interior.
Referring to Figure 17, according to the another embodiment of present inventive concept, the treatment flow of diabetes B is described.Figure 17 The flow chart according to the 4th embodiment is illustrated, which depict the process step 700 for the treatment of diabetes.The program can start In step 702.In step 704, the bile salt and pancreatin of the patient not contacted yet with the food that patient is taken in can be obtained. Step 708, bile salt and the pancreatin reaction of taken in food and patient can be prevented.This can occur in several ways, For example, the energy process and mechanical treatment of the above.In addition, other also can be used to be used for preventing the bile salt of patient and the energy of pancreatin Amount delivering or mechanical technique, and be still within the range of present inventive concept.In step 710, taken in food can be prevented The duodenal mucosa of thing and patient are reacted.This can be carried out using above-mentioned energy delivery and mechanical treatment.Alternatively, it is also possible to Using other energy deliveries or mechanical technique, and it is still within the scope of present inventive concept., can be by institute in step 712 The bile salt and pancreatin of acquisition are delivered to the jejunum of patient.The program can end at step 714.
According to the embodiment, treatment can be based on not（With the food of intake）The bile salt and pancreatin of reaction are from ductus pancreaticus and courage Direct conveying of the pipe to jejunum.Method described in the embodiment can not only be used for treating diabetes, and can be used for changing Symptom, treatment metabolic syndrome, improvement glucose tolerance, the insulin resistance in reduction patient and the reduction of kind diabetes Body weight or obesity, etc..May be different for the therapeutic scheme of each in these treatments, and it is still within present inventive concept Within the scope of.
Said procedure can provide the change of the mucous membrane of proximal small bowel in itself, leave the bottom of change, the bottom of this change Layer thus can change hormonal milieu in a manner of mitigating diabetes.Furthermore, it is possible to change stomach using therapeutic Endoscopic method Intestinal mucosa, to change hormonal balance, for treating the illness of metabolism mediation, such as diabetes.In addition, therapeutic Endoscopic method The change of gastrointestinal mucosa can be promoted, so as to change cholesterol transport and treatment hypercholesterolemia.According to various other implementations Scheme, other illnesss and factor can be treated by changing duodenal mucosa.These illnesss and factor may include that energy disappears Consumption；Body weight, appetite, insulin resistance；Absorb syndrome and malabsorption（Abdominal cavity）；Again jejunal mucous membrane is grown.
The growth of local near-end and/or distant mucosal can be allowed according to processing of the described program to duodenal mucosa, should Mucous membrane can have different and more favourable hormone features in the control of diabetes.For example, distal jejunum tissue can be entered Row processing, to allow ileum to be grown in near-end.In another embodiment, terminal ileum mucous membrane can be handled to incite somebody to action It replaces with the ileal mucous membrane and/or mucous membrane of colon closer to end, therefore prevents bile salt and cholesterol to be ingested.Therefore, this can As the treatment to hypercholesterolemia.According to an embodiment, this can by by mucous membrane/stem cell from an area of enteric cavity It is transplanted to another region and is realized to evoke the change of mucous membrane behavior due to the presence of different stem cells in domain.Processing routine is also It can include from terminal ileum explant mucosal tissue and transplant cells into the duodenum through processing to induce ileal mucous membrane to exist More proximally grown in small intestine, because some hormone cells from distal small bowel（L cells）Be considered as in response to food group and Discharge anti-diabetic hormone.
Also mucous membrane can be handled to certain depth.For example, top layer can remove, and bottom is kept intact, for example, part by Damage.The program can be carried out by using ablations such as RF, laser, low temperature such as microwaves.
Because the level in duodenal bulb occurs for many hormone signal conduction activities, therefore present treatment is preferably at this Region is carried out, without any to being caused to the ampulla hepatopancreatica 118 or oddi's sphincter 120 of enteric cavity delivering bile salt and pancreatin Damage or inflammation/narrow.This can be advantageous to improve diabetes and related syndromes, change hormone signal, protection oddi's sphincter 120th, wriggling function, protection ductus pancreaticus, etc. are kept.
With reference to the embodiment above（Figure 14-17）Can be followed by being nursed after program after the program of description.Protected after program Reason can relate to monitor narrow and perforation, monitoring malabsorption, nutriment and/or vitamin supplement, etc..
The embodiment of present inventive concept as described above can provide one kind by non-implantation and No operation operation to control The method for treating diabetes B.The advantages of embodiment of present inventive concept, may is that, pass through the diabetes of endoscope scheme Treatment may not leave implant, may not melt enough enteron aisles and make absorption of nutrient ingredients bad, possibly can not prevent Only bile salt or pancreatin enter enteron aisle, and possibly by the device of interior intracavitary or can not pass through the human dissection outside traditional inner chamber Learn device or region conveys food to avoid the interaction with mucomembranous surface again.
The embodiment of present inventive concept can improve glucose responding, and reduce insulin sensitivity.In addition, endocrine The releasable hormone of cell, the hormone can enter from duodenal mucosa in vivo and with the effect for such as influenceing insulin resistance. In addition, releasable different amounts of hormone, and cell can be with carrying out being respond differently to stimulant after present treatment program.This hair Bright design can also realize preventing for glycemic control and regrowth.
In order to change duodenal mucosa, the medicine of local delivery can be used, such as（But it is not limited to）Mitomycin C or Diluted acid.This can combine program as described herein in many ways（To prevent that mucosa regeneration is long, change topographic histology/structure, Induction cicatrization, prevent cicatrization or induction metaplasia）.It can apply or apply in many carriers or together with many carriers With these medicines.
These therapies can also be combined with oral drugs.These medicines may include（But it is not limited to）Vitamin replenisher, Sour blocking drugs, mucous membrane consolidant, bile/pancreatin replenishers, mitomycin C, diluted acid, 5-FU, cyclosporin（M-tor suppresses Agent）, sirolimus, FK506, "-Limus " medicine and any be used for bracket for eluting medicament（drug-eluting stent）Medicine Thing.Toxin can also be expelled to submucosa（Region between muscularize's mucous membrane and epithelium）.In addition, it is possible to use block The reagent of the blood flow of mucous membrane or its nutriment.Sclerotherapy can be used（Cicatrization agent is injected into tissue）It is viscous with changing Film regrowth.
The design of the present invention is also contemplated for the other technologies that can be combined with above-mentioned technology.For example, after particular procedure（Or it Before）Polymer coating can be applied to processing region.When using polymer coating, cell can be handled, for example, being allowed to no work Property, it is then coated with.Furthermore it is possible to coated or sleeve pipe on processing region.Furthermore this can be after particular procedure（Or Before）Occur.Other treatment may include to be used for causing high tropic reaction and/or evoke the support frame and/or branch of fibrosis Frame.In addition, sprayed on material, for example, Nitinol（Nitinol）, available for coating processing region.In addition, it is possible to use mucous membrane/on Skin grafting dermepenthesis thing.In this embodiment, for example, obtaining one piece of jejunum or ileal tissue（Or even esophageal tissue）, it is allowed to grow, and It is placed in duodenum to create the tissue of new type in duodenum.For example, the graft of ileal tissue can be used for The complete area of ileum is created in duodenal processing position.
In one embodiment, melted, be then implanted into sleeve pipe for a period of time, epithelial cell is grown again in the time Go out.In order to prevent improperly wound healing or infection, this is probably necessary.
In above-mentioned some embodiments, protective cap 802 is used as shown in figure 18.This is that one kind is used for protecting hepatopancreatic duct kettle The release mechanism in the region such as abdomen or oddi's sphincter.This technology includes entering broad brimmed hat to conduit interpolation.Can be by cap in the presence of many The mode inserted, be secured in position and removed.For example, cap 802 can be secured in position with spring 804, spring 804 is applied to catheter wall Add outward pressure.After the completion of whole program, the cap can be removed with snare, and remove by endoscope.When temporarily During position, it prevents bile salt from draining emptying into duodenum.Bile and pancreatin enter duodenal from oddi's sphincter and pipeline Part II.Sleeve pipe, such as gastroenteritic power device/sleeve pipe, just it is installed to the distal end of the sphincter（Therefore food and pancreatin and courage Juice salt mixes）, subsequently into sleeve.Area for treatment is restricted to duodenal Part II and farther place by this.Can be across Whole duodenum is melted.Because oddi's sphincter or bile duct can not possibly be damaged, therefore recommend to place a guarantor Protect cap of these elements from ablation.This may relate to mechanical insulated, heat insulation, is electrically insulated or is allowed to optically opaque.
The system and device of present inventive concept include one or more structures and arrange the processing elements for handling target tissue Part.Treatment element can contact with tissue, such as hot or cold（Such as low temperature）The sacculus of fluid filling or expansible cage, expansible cage It is configured to deliver the electrode of radio frequency energy including one or more.Treatment element can be distensible, and/or they can pacify It is attached in expansible element.Expansible element includes but is not limited to：Sacculus；Expandable cage；Can radial development arm；And its group Close.Expansible element is configurable to contact tissue, is engaged with tissue, and potentially urging tissue or otherwise to group Knit applying power.
The device or the treatment element of system or another component of present inventive concept may include one or more coatings, such as apply The coating being layed onto on axle, sacculus or expansible cage.The coating can be configured to for example be released in whole program, Huo Zhebao Hold intact, be such as configured to improve device or the propulsion of component or the lubricant coating of retraction.
Although the preferred embodiment of apparatus and method is described by reference to its development environment, they are only It is the illustrated examples of the principle of present inventive concept.For implementing the above-mentioned assembly of present inventive concept, other embodiments, matching somebody with somebody Put the improvement or combination with method, and the change of the aspect of obvious present inventive concept to those skilled in the art Change, it is contemplated that be included within the scope of the claims.In addition, this application lists method or program in a particular order the step of When, the order that change performs some steps is perhaps possible, or even is favourable, and as described below in some cases The specific steps of method or program claim be not necessarily to be construed as order it is specific, unless explicitly pointing out in the claims This order specificity.

Claims (70)

1. a kind of system for treating patient, it is included：
Elongated tubular comprising distal portion；
The treatment element being positioned in the distal portion of the elongated tubular；
Wherein described treatment element is fabricated and arranged for handling target tissue and reducing the adverse effect to non-target tissue, and And wherein described target tissue includes crossing over to the tissue of ligament of Treitz, and the non-target tissue from pylorus in intestines and stomach Comprising at least one in ampulla hepatopancreatica and oddi's sphincter；And
Tissue distention device, it includes more than one syringe needle, and the syringe needle is arranged and configured into submucosa tissue Delivering fluid carrys out submucosa tissue described in adjacent circumferential expansion, comes place for the treatment element to increase target processing volume Reason.
2. the system as claimed in claim 1, wherein the system does not include chronic implant.
3. the system as claimed in claim 1, wherein the system is fabricated and arranged for handling duodenal mucosa so that Substitute the handled mucosal tissue of mucous membrane and the mucous membrane of before processing differently functions.
4. system as claimed in claim 3, wherein different functions include it is different secrete, different secretory volume and/or not Same absorption characteristic.
5. the system as claimed in claim 1, wherein the target tissue includes the first target tissue part and the second target tissue part, And wherein described system is fabricated and arranged for performing the first processing to handle the first target tissue part and execution second Handle to handle the second target tissue part.
6. system as claimed in claim 5, wherein the first target tissue part partly overlaps with second target tissue.
7. system as claimed in claim 5, wherein first processing and the second processing are dissimilar.
8. the system as claimed in claim 1, wherein the processing of the target tissue includes the cell amendment being selected from the group：Change Cell function；Cell death；Apoptosis；Instant cell death；Meronecrosis；Cell degeneration；The removal of cell；And its group Close.
9. the system as claimed in claim 1, wherein the target tissue includes processing tissue, the processing tissue includes and it is handled Cause the tissue of desired treatment effect.
10. system as claimed in claim 9, wherein the target tissue further includes the safe enough and to spare of tissue, the tissue Safe enough and to spare include close to it is described processing tissue tissue, wherein the safe enough and to spare of the tissue by the tissue treatment most Small influence.
11. system as claimed in claim 10, wherein the treatment group is knitted comprising mucous layer, and the safety of wherein described tissue Enough and to spare includes at least a portion layer of submucosa.
12. the system as claimed in claim 1, wherein the target tissue includes depth, length and width, and wherein described depth Degree changes along length and/or width.
13. system as claimed in claim 12, the wherein system are fabricated and arranged in the first processing step and second Target tissue is handled in processing step.
14. system as claimed in claim 13, wherein first processing step and the second processing step include difference Energy delivery.
15. the system as claimed in claim 1, wherein the target tissue includes the first tissue part and minor microstructure part, and And wherein the system is fabricated and arranged for being sequentially processed the first tissue part and the minor microstructure part.
16. such as system of claim 15, wherein the first tissue part has different spies from the minor microstructure part Sign.
17. system as claimed in claim 16, wherein the different feature includes one or more organization types.
18. system as claimed in claim 17, wherein one or more of organization types are close including tissue channel type, tissue Degree and tissue thickness.
19. system as claimed in claim 15, wherein being different from using for the first tissue processing for handling the first tissue part Minor microstructure processing in processing minor microstructure part.
20. system as claimed in claim 19, wherein between the first tissue processing and minor microstructure processing not With including one or more differences in the tissue temperature in energy level, delivering duration and delivery process.
21. the system as claimed in claim 1, wherein the treatment element is fabricated and is arranged to radially distensible and/or can Radially extend.
22. such as system of claim 21, wherein the treatment element is fabricated and is arranged to radial dilatation and/or radially extends To at least 1cm diameter.
23. the system as claimed in claim 1, wherein the treatment element includes expandable sacculus, the sacculus includes temperature 65 DEG C to 90 DEG C of fluid.
24. the system as claimed in claim 1, further comprising second processing element.
25. system as claimed in claim 24, further comprising the second elongated tubular, wherein the second processing element is placed on On second elongated tubular.
26. the system as claimed in claim 1, wherein the treatment element is fabricated and arranged for delivering energy.
27. such as system of claim 26, wherein the treatment element is fabricated and arranged for closed loop energy delivery.
28. system as claimed in claim 27, further comprising sensor, wherein the system is fabricated and arranged for base Energy is delivered in the signal by sensor record.
29. the system as claimed in claim 1, wherein the treatment element is fabricated and arranged for delivering the energy being selected from the group Amount：Electromagnetic energy；Acoustic energy；Luminous energy；Chemical energy；Heat energy；Cold energy；Mechanical energy.
30. system as claimed in claim 29, wherein the electromagnetic energy includes radio frequency energy；The acoustic energy include ultrasound can and time Acoustic energy；The luminous energy includes laser energy, infrared energy and visible luminous energy；The heat energy includes the heat energy that hot fluid is discharged；It is described Mechanical energy includes the mechanical energy that abrasive element is provided.
31. the system as claimed in claim 1, wherein the treatment element is fabricated and arranges the energy for delivering two kinds of forms Amount.
32. system as claimed in claim 31, wherein the treatment element is fabricated and arranged for delivering the first form Energy, and the system includes second processing element, and the second processing element is fabricated and is arranged for delivering second The energy of form.
33. system as claimed in claim 31, wherein the system is fabricated and arranged for simultaneously and/or sequentially delivering The energy of described two forms.
34. the system as claimed in claim 1, it is fabricated and arranges for entering dress through body wherein the elongated tubular includes The service aisle put and be able at least a portion inserted.
35. system as claimed in claim 34, wherein the body is selected from into device：Endoscope；Laparoscopic port；Through stomach Into device；Blood vessel guide；And combinations thereof.
36. the system as claimed in claim 1, wherein the distal portion is fabricated and is arranged to deflection.
37. the system as claimed in claim 1, further comprising the second elongated tubular.
38. system as claimed in claim 37, wherein second elongated tubular is slidably received by the elongated tubular.
39. system as claimed in claim 37, further comprising the second processing element being positioned on second elongated tubular.
40. the system as claimed in claim 1, further include and build and arrange the sensor for providing signal.
41. system as claimed in claim 40, further comprising expansible element, and wherein described sensor is installed to institute State in expansible element.
42. system as claimed in claim 40, wherein the sensor includes the sensor being selected from the group：Heat sensor；Resistance Anti- sensor；Pressure sensor；Blood sensor；Optical sensor；Sonic transducer；Electromagnetic sensor；And combinations thereof.
43. system as claimed in claim 42, wherein the heat sensor includes thermocouple；The impedance transducer includes group Knit impedance transducer；The optical sensor includes optical sensor；The sonic transducer includes ultrasonic sensor；The electromagnetism Sensor includes emf sensor.
44. the system as claimed in claim 1, further comprising function element.
45. system as claimed in claim 44, wherein the function element is selected from：Sensor；Transducer；Vacuum port；Visually Change element or device；And combinations thereof.
46. system as claimed in claim 45, wherein visualization element or device include ultrasonic crystal or optics assembly.
47. system as claimed in claim 44, wherein the function element includes vacuum port.
48. system as claimed in claim 47, wherein the vacuum port is fabricated and arranged for removing tissue.
49. system as claimed in claim 47, wherein the vacuum port is fabricated and arranged for causing the system extremely A few part contacts with tissue.
50. the system as claimed in claim 1, further include and build and arrange the body cavity pressurization group for delivering pressure fluid Piece installing.
51. system as claimed in claim 50, wherein body cavity pressurization assembly includes injection fluid source.
52. system as claimed in claim 50, further include the occlusion for building and arranging for preventing pressure fluid from migrating Element.
53. system as claimed in claim 52, wherein the blocking element is installed on the elongated tubular.
54. the system as claimed in claim 1, further enter device comprising body, and wherein described elongated tubular is fabricated simultaneously Arrange for entering device through body and insert.
55. system as claimed in claim 54, wherein the body is selected from into device：Endoscope；Laparoscopic port；Through stomach Into device；Blood vessel guide；And combinations thereof.
56. the system as claimed in claim 1, further include and build and arrange for delivering energy to the treatment element Energy delivery unit.
57. system as claimed in claim 56, wherein the energy delivery unit be fabricated and arrange for deliver two kinds or The energy of more kinds of forms.
58. system as claimed in claim 56, it is used for wherein the energy delivery unit is fabricated and arranged to the processing Element provides closed loop energy delivery.
59. the system as claimed in claim 1, further comprising controller and user interface.
60. system as claimed in claim 59, wherein the controller is fabricated and arranged for allowing operator to adjust choosing From the system input parameter of the following group：The type for the energy that will be delivered；The amount for the energy that will be delivered；The energy bins that will be delivered The type and level of conjunction；The energy delivery duration；The pulsewidth modulation percentage of the energy delivered；Abrasion device crosses past Number is moved again；The temperature for the treatment of element；Inject pressure；Inject the duration；And combinations thereof.
61. system as claimed in claim 60, wherein the type of the energy that will be delivered include radio frequency energy, heat energy and/ Or mechanical energy；The accumulation joule number for the energy that the amount of the energy that will be delivered includes delivering or the energy that will be delivered Peak volume；The temperature of the treatment element includes target temperature or maximum temperature.
62. system as claimed in claim 59, wherein the user interface is fabricated and arranged for showing what is be selected from the group System output parameter：Temperature information；Pressure information；The information of power；Patient information；And combinations thereof.
63. system as claimed in claim 62, wherein the temperature information includes tissue and/or treatment element temperature information； The pressure information includes balloon pressure information or injection pressure information；The information of the power includes being applied to structural power water Flat information；The patient information is included by the physiologic information of the patient of one or more sensor records.
64. the system as claimed in claim 1, further include and build and arrange for translating and/or rotating the processing elements Assembly is transmitted in the motion of part.
65. the system as claimed in claim 1, further include and build and arrange for protecting non-target in organization processes The protective cap of tissue.
66. the system as claimed in claim 1, further comprising manipulation device.
67. the system as described in claim 66, it is selected from down wherein the manipulation device is fabricated and arranged for execution The function of group：Axially aligning；Tensioning；Thickness is expanded；Apply axial force to tissue；Apply axially opposite power to tissue；To group Knit application radial load；Urging tissue；Induce localized edema or angioedema；Radial dilatation duodenum；And combinations thereof.
68. the system as described in claim 67, wherein the axially aligning includes duodenum or the aligning of other intestinal tissues, The tensioning includes axially and/or radially tensioning；The thickness expansion includes the expansion injected fluid to the submucosa of intestines ；The urging tissue includes oppressing duodenal fine hair；The radial dilatation duodenum, to reduce the prominent of valvulae conniventes Rise and prevent or reduce caused by treatment element folds pleat to the undertreatment of these pleats.
69. system as recited in claim 68, wherein the injected fluid includes injected liquid or gas.
70. the system as claimed in claim 1, further complete algorithm comprising program.
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