KR102231179B1 - Tissue expansion devices, systems and methods - Google Patents

Abstract

A device for expanding tissue includes at least one fluid transfer tube and at least one fluid transfer element in fluid communication with the at least one fluid transfer tube. The at least one fluid transfer tube includes a proximal end, a distal end, and a lumen therebetween. The device is constructed and arranged to effect an almost total circumferential expansion of the lumen wall tissue. In addition, systems and methods are provided, including a system for expanding tissue layers and treating tissue proximate the expanded tissue layers.

Description

TISSUE EXPANSION DEVICES, SYSTEMS AND METHODS

Cross-reference of related applications

This application claims the enjoyment of U.S. Provisional Application No. 61/635,810 (Attorney Docket No. 41714-705.101), filed April 19, 2012, the entire contents of which are incorporated herein by reference; This application is also filed on January 18, 2012, PCT Application No. PCT/US2012/01739 (Attorney Docket No. 41714-703.601) and PCT Application No. PCT/US2013/28082, filed February 27, 2013 (Attorney Docket No. 41714-704.601), the contents of each of which are incorporated herein by reference in their entirety.

The embodiments disclosed herein generally relate to systems, devices and methods for expanding one or more layers of tissue, particularly gastrointestinal tissue.

The field of gastrointestinal endoscopy has, for many years, focused on diagnostic and therapeutic techniques for observing, modifying and removing tissues that will be located within the digestive tract. For example, prior to a procedure to remove or otherwise deform tissue, the method referred to in this field as “lift and cut” is to elevate and/or raise the submucosa. In an attempt to expand, injecting saline or other biocompatible solution below the mucosal tissue, thereby changing the geometry to make it suitable for treatment, e.g. tissue resection. Includes. In some cases, an infusion catheter is used to deliver fluid within the submucosal tissue layer, not easily dissipate throughout the target area, and when the target ablation area is raised and/or expanded, the tissue Can be defeated.

However, current devices, systems and methods for dilating submucosal tissue and other tissue layers are cumbersome, inaccurate, and have a limited effective tissue area. Accordingly, there is a need for improved devices, systems and methods for inflating submucosal tissue and other tissue layers that provide a simplified use, larger area of inflation, and reduced procedure time.

According to one aspect of the inventive concepts, a device for inflating tissue comprises: at least one fluid transfer tube comprising a proximal end, a distal end and a lumen therebetween; And at least one fluid transfer element in fluid communication with the at least one fluid transfer tube lumen, wherein the device expands one or more layers of tissue, such as to effect an almost overall circumferential expansion of the luminal wall tissue. It is configured to let.

In some embodiments, the device is configured to effect a near total circumferential expansion of the lumen wall tissue. Nearly circumferential expansion can be carried out in a single operator fluid delivery step, for example, wherein the at least one fluid transfer element comprises two or more fluid transfer elements and fluid transfer from two or more fluid transfer elements occurs simultaneously or sequentially. I can. Alternatively, the nearly circumferential expansion can be effected with multiple operator fluid delivery steps.

In some embodiments, the device is configured to narrow the lumen surrounded by the lumen wall tissue, for example, to 85% or less of the diameter prior to lumen wall tissue expansion, or in some cases to 75% or less. do.

In some embodiments, the device is configured to smooth the inner surface of the luminal wall tissue, for example a plicae of the gastrointestinal tract.

In some embodiments, the device is configured to deliver a pre-determined volume of fluid into the tissue. The volume of fluid delivered may range from about 0.5 ml to 4.0 ml, and such volume may be delivered 2 to 10 times. The volume of fluid delivered may be about 1.0 ml to 3.0 ml, and such volume may be delivered 2 to 10 times.

In some embodiments, the device is configured to provide pressure-controlled fluid delivery into tissue. The device can deliver fluid until the maximum pressure is reached, or the pressure is above the minimum level.

In some embodiments, the device is configured to expand the first layer of tissue while preventing expansion of the second deeper layer of tissue. Conversely, the device may be configured to expand the first layer of tissue while preventing expansion of the second, shallower layer of tissue.

In some embodiments, the device is configured to cause the at least one fluid delivery element to initially penetrate the wrinkles of the gastrointestinal tract.

One or more layers of tissue to be expanded may include lumen wall tissue. One or more layers of tissue to be expanded may include submucosal tissue, such as duodenal submucosal tissue. The device includes: mucosal layer tissue, muscle layer tissue, serosal layer tissue; It may be configured to avoid swelling of the tissue selected from the group consisting of combinations thereof. Other types of tissue that can be expanded by the device include the gastrointestinal tissue layer; Duodenal tissue layer; Esophageal tissue layer; Small intestine tissue layer; Ileal tissue layer; Colon tissue layer; Gastrointestinal (stomach) tissue layer; Bladder tissue layer; Oral tissue layer; Layer of uterine tissue; And combinations thereof.

The at least one fluid transfer element may comprise two or more fluid transfer elements, for example first and second fluid transfer elements. The first and second fluid transfer elements may be similar or different. The first fluid transfer element and the second fluid transfer element can be configured to deliver fluid simultaneously and/or sequentially. The at least one fluid transfer tube may comprise a single fluid transfer tube, the first fluid transfer element and the second fluid transfer element being fluidly connected to the single fluid transfer tube. Alternatively, the at least one fluid transfer tube may comprise at least two fluid transfer tubes, wherein the first fluid transfer element is fluidly connected to the first fluid transfer tube and the second fluid transfer element is a second Fluidly connected to the fluid transfer tube.

The at least one fluid transfer element may include three or more fluid transfer elements arranged in a relatively circumferential arrangement. In some embodiments, the device includes a support assembly, with three or more fluid transfer elements disposed on and/or within the support assembly. The support assembly includes at least one balloon; Two or more support arms; A radially deployable structure; And a support structure selected from the group consisting of combinations thereof. The support assembly may include two or more support arms, wherein the first fluid transfer element is disposed proximate the first support arm and the second fluid transfer element is disposed proximate the second support arm. At least one transfer element may comprise at least four fluid transfer elements, the support assembly comprising at least four support arms, the fluid transfer element being positioned proximate each of the four support arms. The support assembly may include a radially expandable support assembly that is expandable through a retractable shaft. The support assembly is configured to be biased in a radially expanded state, and may also include a support assembly configured to be radially compressed. The support assembly may comprise two or more tubes, each of which surrounds a fluid transfer element, for example two or more tubes slidingly engaged with the fluid transfer element. Each of the two or more tubes may include an outlet port through which the fluid delivery element may be advanced. Each of the two or more tubes may include a vacuum port, configured to apply tension to the tissue. Each of the two or more tubes may include an inlet port, configured to allow passage of tissue. The support assembly may include two or more outlet ports through which the fluid transfer element can be advanced and a vacuum can be applied to the two or more outlet ports. The support assembly can include at least one vacuum port.

The device may further comprise at least one outlet port, and the at least one fluid transfer element is configured to be advancing out of the at least one outlet port. The device can be configured to apply a vacuum to at least one outlet port. The device may further include an elongated shaft for receiving at least one fluid transfer tube in a sliding manner, wherein at least one outlet port is disposed on a side portion of the elongated shaft, and the device is outside the at least one outlet port. It may be configured to allow an operator to adjust the trajectory of at least one fluid transfer element into the furnace.

The at least one fluid transfer element may comprise an advancing fluid transfer element. For example, the fluid transfer element can be advanced by an operator. The device may include a control configured to advance at least one fluid transfer element, the control may be disposed on a handle of the device. The control unit may be configured to allow an operator to change the advancement of the at least one fluid delivery element. The device may include a guide surface configured to guide and/or maintain a predetermined trajectory for at least one fluid transfer element. The device may include a surface disposed to limit advancement of at least one fluid transfer element. The at least one fluid transfer element can be advanced a fixed distance, for example a distance set by the operator. Such distances may range from about 1 mm to 10 mm, or from about 3 mm to 7 mm. The device may comprise an elongated shaft comprising a recess portion surrounding at least one fluid transfer tube, the at least one fluid transfer element configured to advance into the recess portion. The device can include an elongated shaft having a distal end surrounding at least one fluid transfer tube, the at least one fluid transfer element configured to advance out of the shaft distal end. The at least one fluid transfer element can be resiliently deflected in a retracted state, for example via a spring element. The at least one fluid transfer element may include a first fluid transfer element and a second fluid transfer element, each of the fluid transfer elements being deflected in a retracted state.

The at least one fluid transfer element may comprise at least two fluid transfer elements, each fluid transfer element comprising advancing fluid transfer elements. For example, the first fluid transfer element can be advancing independently from the second fluid transfer element. Alternatively, the first and second fluid transfer elements can be advanced simultaneously.

The device may further include a spring loaded fluid delivery advancing assembly. Such an assembly can be configured to be activated by an operator. Such an assembly may be configured to advance a plurality of fluid transfer elements, and in some cases, a plurality of fluid transfer elements may be advanced independently of each other.

As the tissue expands, the at least one fluid transfer element can be configured to move laterally.

The at least one fluid transfer element comprises: a needle; Water jet; Iontophoretic elements; Porous elements; And at least one element selected from the group consisting of combinations thereof. In embodiments in which the at least one fluid transfer element comprises a needle, the device may comprise an elongate shaft having a recess, the needle being constructed and arranged to be held within the elongated shaft recess. The needle diameter may range from about 25 to 35 gauge, for example about 23 to 27 gauge. The needle, at least one side hole; Porous section; And a solid tip needle comprising an outlet port, selected from the group consisting of combinations thereof. The needle may include at least one side hole. The needle can be configured to penetrate through mucosal tissue and into submucosal tissue but not to muscle tissue. The needle can be configured to penetrate through mucosal tissue and into submucosal tissue but not to penetrate serous tissue. The needle may comprise an exposed length of 10 mm or less, for example an exposed length of 7 mm or less. The needle may comprise an inflatable support, such as a balloon; Cage; One or more radially extending arms; And combinations thereof.

The at least one fluid transfer element can include a sharp distal end. The at least one fluid transfer element may include a beveled distal end, for example the angle of inclination ranging from 10° to 60°, for example an angle of inclination of about 30°.

The at least one fluid delivery element can comprise a water sprayer, and the water sprayer can comprise a nozzle configured to cause a fluid to penetrate one or more tissue layers.

The device may further include a fluid configured to be delivered to tissue through at least one fluid delivery element. The fluid is a liquid; gas; And combinations thereof. For example, the fluid may be water; Saline solutions such as hypertonic saline; air; C0 ₂ ; One or more hydrogels; Epinephrine; Hypertonic glucose water; Hyaluronic acid; Glycerol solutions; And combinations thereof. The fluid can be a fluid that provides a visual image corresponding to the amount of tissue swelling, for example methylene blue; dyes; Radiopaque fluid; MR visualizable fluid; Ultrasonically visible fluid; And combinations thereof. The fluid may include a magnetic fluid. As the fluid temperature changes, the fluid can change its color. The fluid may comprise at least two fluids, for example a first fluid having a first reflective color and a second fluid having a second reflective color, wherein the device delivers the first fluid through the first fluid transfer element. And is configured to deliver a second fluid through the second fluid transfer element. Fluids include fluids that are heated prior to delivery into tissue. Fluids can include fluids that are configured to change viscosity after delivery into tissue, for example the fluid can increase or decrease viscosity after delivery into tissue. The fluid may include a fluid similar to the osmotic pressure on the tissue. The fluid may include a fluid configured as an insulator. The fluid may include glycerol and saline, such as heated glycerol and saline. The fluid may contain a bioactive function, for example a sclerosan; Anti-inflammatory; Antimicrotubule inhibitors or other mitotic inhibitors; Alkylating agents; Antimetabolite; Anthracycline; Plant alkaloids; Topoisomerase inhibitors; Anti-proliferative; And combinations thereof.

The device comprises: an organization; Fluid; Delivered fluid; And a manipulating assembly, configured to manipulate one or more of these combinations. The operating assembly can include a vacuum port. The vacuum port may comprise a width of 2.0 mm or less, and also 1.5 mm or less, or 1.0 mm or less. The vacuum port may comprise a length of 5.0 mm or less, or 4.0 mm or less, or 3.0 mm or less. The vacuum port can have a width of about 1.5 mm and a length of about 4.0 mm. The device may further include a lumen in fluid communication with the vacuum port. The device may further comprise a vacuum generator in fluid communication with the vacuum port. The vacuum port can be configured to move tissue towards the at least one fluid delivery element. The device may be configured to apply a vacuum of about 5 cmHg to 45 cmHg below atmospheric pressure to the vacuum port, for example, to apply a vacuum of about 5 cmHg to 20 cmHg below atmospheric pressure to the vacuum port. The device may be configured to allow an operator to adjust the pressure applied to the vacuum port. The manipulation assembly may be configured to prevent movement of that portion of tissue as at least one fluid transfer element penetrates into the portion of tissue. The manipulation assembly may be configured to prevent movement of that portion of tissue as at least one fluid transfer element delivers fluid into the portion of tissue. The manipulation assembly may be configured to move fluid previously delivered to the tissue, for example through vacuum and/or through the application of a translational force across the tissue. The manipulation assembly can be configured to direct a flow of fluid delivered into the tissue. The operation assembly includes: a balloon; An inflatable ring; Vacuum port; A grasper such as a pair of articulated jaws; A radially expandable cage; A radially deployable arm; And one or more components selected from the group consisting of combinations thereof.

The device may further include a lumen sealing element configured to at least partially occlude a lumen of the at least one fluid transfer tube surrounded by tissue. For example, the lumen sealing element may comprise a balloon disposed proximal or distal to the at least one fluid transfer element.

The device may further include a pressure monitoring assembly configured to monitor the pressure before, during, and/or after expansion of the tissue.

The device may further include a diagnostic assembly configured to perform an assessment of tissue swelling. For example, the diagnostic assembly may include an amount of tissue expansion; The thickness of one or more tissue layers; Penetration of at least one fluid transfer element into tissue; Combinations of these can be evaluated. The diagnostic assembly can include a visualization assembly. The visualization assembly can be configured to monitor the color intensity of fluid delivered into the tissue. The visualization assembly includes a visible light camera; Ultrasonic imaging device; OCT device; OCDR device; Confocal endomicroscopy via scanning or structured illumination; It may include a component selected from the group consisting of combinations thereof. The visualization assembly may further include a light emission source configured to monitor the depth of penetration of the at least one fluid delivery element into tissue. The diagnostic assembly may comprise a tissue analyzer, such as an ultrasonic tissue analyzer configured to provide tissue thickness information. The diagnostic assembly can include an impedance measurement element. The diagnostic assembly can be configured to deliver a heated and/or cooled fluid and to evaluate tissue expansion based on a measured temperature change.

The device may further include at least one sensor. At least one sensor may include a temperature sensor; Impedance sensor; Optical sensor; Pressure sensor; Strain gauge; Force sensor; And a sensor selected from the group consisting of combinations thereof. The sensor includes: the amount of tissue swelling; Current tissue thickness (eg, before, during and/or after expansion); Tissue layer thickness; Depth of penetration of the fluid transfer element; Color density of the delivered fluid; Tissue impedance; The temperature of the tissue, such as the temperature of the tissue that has received the heated or cooled fluid through the needle; It may be configured to perform a function selected from the group consisting of quantifying or otherwise evaluating one or more of these combinations.

The device may further comprise an expandable element. The expansion element can be configured to minimize movement of fluid delivered to the tissue. For example, the inflatable element may comprise a balloon. The inflatable element may comprise a first balloon and a second balloon, with at least one fluid transfer element positioned between the first and second balloons. The expandable element may comprise a tapered profile. The expandable element may comprise a dog-bone contour. The expandable element may comprise at least one recess. The at least one fluid transfer element can be configured to be positioned within the at least one recess and/or to advance within the at least one recess. A vacuum port can be disposed in the at least one recess.

The device may further include an elongated shaft surrounding the at least one fluid transfer tube.

The at least one fluid transfer element may include a first fluid transfer element and a second fluid transfer element, wherein the at least one fluid transfer tube comprises a first fluid transfer tube and a second fluid in fluid communication with the first fluid transfer element. And a second fluid transfer tube in fluid communication with the transfer element. The device may further include a shaft surrounding the first fluid transfer tube and the second fluid transfer tube, the first fluid transfer tube and the second fluid transfer tube disposed in a side-by-side arrangement.

The at least one fluid transfer element can include at least three fluid transfer elements. The at least one fluid transfer tube may comprise at least three fluid transfer tubes connected one by one to the at least three fluid transfer elements. Alternatively, the at least one fluid transfer tube can comprise one fluid transfer tube, and the device can connect a single fluid transfer tube to a first fluid transfer element, a second fluid transfer element, and a third fluid transfer element. It further includes a manifold configured to be.

The at least one fluid transfer element can include at least four fluid transfer elements. The at least one fluid transfer tube may comprise at least four fluid transfer tubes connected one by one to the at least four fluid transfer elements. Alternatively, the at least one fluid transfer tube may comprise one fluid transfer tube, and the device may incorporate a single fluid transfer tube into a first fluid transfer element, a second fluid transfer element, a third fluid transfer element, and a fourth. It further comprises a manifold configured to be connected to the fluid transfer element.

In some embodiments, the device is configured to be inserted through an endoscope. In some embodiments, the device is configured to be inserted through a lumen of 13 mm or less, or a lumen of 8 mm or less, or a lumen of 6 mm or less.

In some embodiments, the device comprises a workable insertion length of at least 25 cm, or at least 35 cm, or at least 100 cm, or at least 140 cm.

In some embodiments, the device is configured for over-the-wire delivery into the gastrointestinal tract. The device may comprise a lumen configured to receive the guide wire in a sliding manner. Additionally or alternatively, the device may comprise a sidecar configured to rapidly exchange transmissions across the guide wire.

The device may further comprise an elongate shaft surrounding the at least one fluid transfer tube, the at least one fluid transfer element configured to be advanced from the elongate shaft, for example the elongate shaft comprising an endoscopic shaft.

The device may further include an elongated shaft surrounding at least one fluid transfer tube and comprising a distal portion and an opening disposed in the distal portion. At least one fluid transfer element can be disposed within the distal partial opening. The at least one fluid transfer element may be configured to be advancing into the distal partial opening. The device can be configured to apply a vacuum to the distal partial opening. The distal portion opening may include a recess in the elongate shaft distal portion.

According to another aspect of the concepts of the present invention, a method comprises: at least one fluid transfer tube comprising a proximal end, a distal end, and a lumen therebetween; And at least one fluid transfer element in fluid communication with the at least one fluid transfer tube lumen; And delivering fluid through the at least one fluid transfer element into the first tissue location to expand the one or more layers of tissue.

Delivering fluid to a first tissue location through at least one fluid transfer element to expand one or more layers of tissue may include simultaneously transferring fluid through at least two fluid transfer elements.

One or more layers of tissue may be expanded to move the inner layer of tissue towards the treatment element.

The method may further include delivering a second volume of fluid. The second volume of fluid can be delivered to the first tissue location, or to a different second tissue location.

The method further includes moving the delivered fluid present in the tissue. The fluid present in the tissue may move as the fluid is delivered through the fluid delivery element.

The method may further include applying a force to the tissue prior to and/or during delivery of the fluid. The force may be applied by two inflatable elements, for example two inflatable balloons.

The method may further include manipulating the first tissue location and/or tissue adjacent the first tissue location prior to delivering the fluid to the first tissue location. Manipulating may include applying a vacuum. The at least one fluid transfer element can be advanced into the vacuum manipulated tissue, for example the at least one fluid transfer element comprises a needle. Alternatively or additionally, manipulating may include grasping the tissue with a tool.

The method may further include monitoring the swelling of the tissue. For example, monitoring may include monitoring tissue expansion for sufficiency.

The method may further include ablating tissue proximate to the expanded tissue.

Advantages of the above-described technology may be better understood, along with additional advantages, by reference to the following description taken in conjunction with the accompanying drawings. The drawings are not necessarily drawn to scale, but instead have been generally emphasized when describing the principles of technology.
1 is a side view illustrating a tissue expansion device including a plurality of fluid delivery elements in a retracted state, consistent with the concepts of the present invention.
1A is a side view illustrating the tissue inflation device of FIG. 1 with a plurality of fluid transfer elements in an advanced state, consistent with the concepts of the present invention.
2 is a flow diagram illustrating a method for tissue expansion, consistent with the concepts of the present invention.
3A, 3B and 3C are a series of side and end views showing a segment of luminal wall tissue before, during, and after, respectively, overall circumferential tissue expansion, consistent with the concepts of the present invention.
4 is a side view showing a distal portion of a tissue inflation device, including an interdeployable expandable assembly, consistent with the concepts of the present invention.
4A is a side view showing the tissue inflation device of FIG. 4 after radial expansion of the deployable assembly, consistent with the concepts of the present invention.
4B is a side view illustrating the tissue expansion device of FIGS. 4 and 4A after radial expansion of the deployable assembly and advancing of the fluid transfer elements, consistent with the concepts of the present invention.
5 is a side view and an end view showing a distal portion of a tissue expansion device, including a self-expanding assembly, consistent with the concepts of the present invention.
5A is a cross-sectional side view showing a segment of a support arm of a tissue inflation device, including a support member for a fluid transfer element, consistent with the concepts of the present invention.
5B is a plan view showing an opening in a support arm of a tissue inflation device, consistent with the concepts of the present invention.
5C is a perspective view showing an alternative opening of a support arm, consistent with the concepts of the present invention.
6 is a cross-sectional side view showing a distal portion of a fluid delivery element disposed within a body lumen and comprising a permeator and an atraumatic circumferential tube, consistent with the concepts of the present invention.
6A is a cross-sectional side view showing the fluid transfer element of FIG. 6 after the tube has been advanced over the permeator and into tissue, consistent with the concepts of the present invention.
6B is a cross-sectional side view illustrating the fluid transfer element of FIGS. 6 and 6A after fluid has been injected into a layer of tissue, consistent with the concepts of the present invention.
7 is a cross-sectional side view showing a fluid delivery element including a needle positioned within a body lumen with an inner lumen, consistent with the concepts of the present invention.
8 is a cross-sectional side view illustrating a fluid delivery element comprising a nozzle and a water jet disposed within a body lumen and comprising a nozzle and an inner lumen, consistent with the concepts of the present invention.
9 is a cross-sectional side view illustrating a fluid delivery element disposed within a body lumen and including an iontophoretic fluid delivery assembly, consistent with the concepts of the present invention.
10 is a cross-sectional side view showing a distal portion of a tissue inflation device including a side recess portion and a protected needle exit port, consistent with the concepts of the present invention.
10A is a cross-sectional side view illustrating the tissue inflation device of FIG. 10 after the device has been placed in proximity to tissue, consistent with the concepts of the present invention.
10B is a cross-sectional side view showing the tissue inflation device of FIGS. 10 and 10A after the needle has been axially advanced into the tissue, consistent with the concepts of the present invention.
11 is a cross-sectional side view showing a distal portion of a tissue inflation device including an end recess portion and a protected needle exit port, consistent with the concepts of the present invention.
12 is a cross-sectional side view showing a distal portion of a tissue inflation device positioned within a body lumen and including an endoscope and an advancing needle, consistent with the concepts of the present invention.
13 is a cross-sectional side view illustrating a distal portion of a tissue expansion device including a plurality of needles and a fluid distribution manifold, consistent with the concepts of the present invention.
13A is an enlarged side cross-sectional view of the fluid distribution manifold of FIG. 13, consistent with the concepts of the present invention.
13B is an enlarged cross-sectional view of the support arm of FIG. 13, consistent with the concepts of the present invention.
14 is a cross-sectional side view showing a distal portion of a tissue expansion device including a spring-loaded needle injector, consistent with the concepts of the present invention.
14A is a cross-sectional side view showing the distal portion of the tissue inflation device of FIG. 14 after advancement of the needle by a spring-loaded injector, consistent with the concepts of the present invention.
15 is a cross-sectional side view showing a distal portion of a tissue inflation device including a needle deflected in a retracted state, consistent with the concepts of the present invention.
15A is a cross-sectional side view showing the distal portion of the tissue inflation device of FIG. 15 after advancement of the needle, consistent with the concepts of the present invention.
16 is a cross-sectional side view showing a distal portion of a tissue expansion device including a fluid delivery element including a lumen obturator assembly and a needle, each disposed within a body lumen, consistent with the concepts of the present invention.
16A is a cross-sectional side view illustrating the fluid transfer element and lumen closure assembly of FIG. 16 after the lumen closure assembly contacts tissue, consistent with the concepts of the present invention.
16B is a cross-sectional side view illustrating the fluid transfer element and lumen occlusion assembly of FIGS. 16 and 16A after the needle has advanced into tissue, consistent with the concepts of the present invention.
16C is a cross-sectional side view illustrating the lumen occlusion assembly and fluid delivery element of FIGS. 16, 16A and 16B after fluid has advanced into tissue through an opening in the needle, consistent with the concepts of the present invention.
17 is a cross-sectional side view showing a distal portion of a tissue inflation device including a fluid delivery element having an operator adjustable needle trajectory guide consistent with the concepts of the present invention.
FIG. 17A is a diagram illustrating the tissue inflation device of FIG. 17 after the adjustable guide has been rotated so that the trajectory taken by the needle is towards the distal end of the device, consistent with the concepts of the present invention.
FIG. 17B is a diagram illustrating the tissue inflation device of FIG. 17 after the adjustable guide has been rotated so that the trajectory taken by the needle is towards the proximal end of the device, consistent with the concepts of the present invention.
18 is a cross-sectional side view illustrating a fluid transfer element comprising a needle having a side hole and arranged to penetrate the needle into a second tissue layer of a body lumen, consistent with the concepts of the present invention.
18A is a cross-sectional side view illustrating the fluid delivery element of FIG. 18 after the injected fluid expands the second layer of tissue, consistent with the concepts of the present invention.
18B is a cross-sectional side view illustrating the fluid delivery element of FIGS. 18 and 18A after introduction into the body lumen of the tissue manipulation assembly in contact with the lumen wall near the injection location, consistent with the concepts of the present invention.
18C is a cross-sectional side view showing the tissue manipulation assembly and fluid delivery element of FIG. 18B after force is applied to the lumen wall to induce a strain on tissue expansion, consistent with the concepts of the present invention.
19 is a diagram illustrating a system for tissue expansion, as well as removal or other target tissue treatment, consistent with the concepts of the present invention.

Reference will now be made specifically to the present embodiments of the concepts of the present invention, examples of such embodiments are shown in the accompanying drawings. In practical cases, the same reference numbers will be used throughout the drawings to refer to the same or similar parts.

The object of the concepts of the present invention is devices, systems for safely and effectively expanding an area of tissue, such as one or more layers of a portion of a tubular or solid tissue, such as tissue of a patient's organ or tissue of the gastrointestinal tract, And methods. Devices and systems of the concepts of the present invention include one or more fluid delivery elements, such as needles or water jets, configured to deliver one or more fluids to a tissue to be inflated. The needles may include hollow or partially hollow needles, such as needles having one or more openings at a distal end and/or at a sidewall location. One or more visualization assemblies may be included to allow an operator to visualize or otherwise evaluate a tissue expansion procedure. One or more tissue manipulation assemblies may be included to apply a force to promote or otherwise deform tissue expansion.

In some embodiments, vacuum or other negative pressure may be used to manipulate the tissue and/or to maintain proximity between the tissue and a portion of the tissue expansion device or assembly. Such vacuum or other negative pressure may include pressures below other pressures, such as those below the patient's environment, referred to hereinafter as “vacuum” or “vacuum pressure”. The vacuum may be provided by one or more vacuum sources, for example, through one or more operator adjustable vacuum sources.

In some embodiments, tissue expansion is performed prior to treatment of the tissue, such as removal of a target volume of tissue. For example, in order to prevent damage to one or more tissue layers below the expanded tissue layer, the devices and systems of the present invention may include one or more removal devices, e. It may further include removal devices configured to treat. In these embodiments, the expanded tissue layer acts as a safe volume of tissue, reducing the specificity of removal and/or protecting the underlying tissue from damage.

Turning now to FIG. 1, there is shown a side view of a device for tissue expansion, including a plurality of fluid transfer elements, consistent with the concepts of the present invention. The device 100 includes a handle 110 fixedly attached to the hollow tube, an outer sheath 109, which is typically a flexible tube made of one or more biocompatible materials. The sheath 109 surrounds the inner shaft 101 and receives it in a sliding manner, which is also a flexible tube typically made of one or more biocompatible materials. The inner shaft 101 includes a distal end 102. In some alternative embodiments, device 100 does not include sheath 109 and inner shaft 101 is fixedly attached to handle 110. An inflatable assembly 130 is attached to the distal portion of the shaft 101, which is typically inflated radially, such as an inflatable balloon, a flexible basket or cage, or a series of radially deployable arms. It is a possible and/or radially compressible assembly. In alternative embodiments, deflection with or without expansion, as described below with reference to FIGS. 6, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17 and 18 Through, forward or other manipulation, the assembly 130 may be oriented or otherwise accessed into the tissue. For example, in order to penetrate the tissue or otherwise be disposed to allow fluid to be delivered into the tissue and to induce one or more layers of tissue to expand, the inflatable assembly 130 may include one or more fluid delivery elements proximate the tissue. It is configured to allow you to do. The inflatable assembly 130 may include one or more openings 131, for example openings 131a and 131b to 131n as shown. The assembly 130 can be constructed and arranged to apply a force to the tissue. For example, the assembly 130 may be constructed and arranged to orient the fluid transfer elements 140 and/or the openings 131 in order to place the openings 131 relatively perpendicular to the lumen wall tissue. I can. The tissue may comprise one or more locations within the patient's body, for example the tissue comprises a body lumen, such as one or more portions of the gastrointestinal tract. Typical tissue locations are described in detail below with reference to FIGS. 3A, 3B and 3C.

Handle 110 may include a variable number of controls and/or groups of controls configured to advance, deploy, or otherwise activate one or more assemblies or components of device 100. Typical controls include one or more mechanical and/or electrical controls such as knobs, levers, switches, solenoids, and the like. Controls may be connected to electrical wires, for example to transfer power to an assembly or component of device 100. The controls may be connected to one or more mechanical linkages, such as advanceable and retractable shafts or linkages comprising cables, cams and pivots. The controls can be configured to activate a hydraulic or pneumatic supply.

The knob 114 is a control unit configured to be rotated to advance and/or retract the inner shaft 101 within the outer sheath 109. In FIG. 1, the inner shaft 101 is advanced so that the inflatable assembly 130 has an exited sheath 109. The expandable assembly 130 may include an assembly that is elastically deflected in the radially expanded condition shown, for example, in the shown radially inflating condition that expands as it exits the sheath 109. Includes a biased Nitinol cage. In these embodiments, the retraction of the shaft 101 is implemented so that the expandable assembly 130 can be pulled within the sheath 109, and the expandable assembly 130 is radial during insertion into the sheath 109. Is compressed. Alternatively, as when the inflatable assembly 130 comprises an array of arms that can be deployed by deflation of the shaft or a balloon that can be an inflatable or deployable cage, the inflatable assembly 130 can: After exiting the sheath 109 may be deployed in a radially expanded condition.

Handle 110 electrically and/or electrically and/or one or more components or assemblies of device 100, for example, by activating one or more fluid valves as described below with reference to FIG. 19. Alternatively, to mechanically activate, for example, to activate the flow of fluid and/or the application of vacuum, one or more control units 111, such as the control units 111a and 111b to 111n as shown, may be included. I can. The handle 110 may include an arrangement of knobs 112 and receiving slots 113, for example knobs 112a and 112b to 112n and receiving slots 113a and 113b to 113n. The knobs 112a and 112b to 112n are not shown, but one or more fluid transfer elements 140, for example, the fluid transfer elements 140a and 140b advancing through the openings 131a and 131b to 131n, respectively. To 140n), individually or collectively, are connectable to one or more linkages. Alternatively or additionally, for example, as described below, when a vacuum is applied to the opening 131 and the tissue is pulled into the opening 131, it does not exit the opening 131, but the opening 131 ) One or more fluid transfer elements 140 may be constructed and arranged to penetrate into tissue by entering into. Numerous ranges of vacuum pressure levels can be applied, such as a vacuum of 5 to 45 cmHg below atmospheric pressure, for example a vacuum of 5 to 20 cmHg below atmospheric pressure. Fluid delivery elements 140 may include, but are not limited to, a needle; A water jet including a nozzle; Iontophoretic element; Porous elements; And combinations thereof. The knobs 112 may be configured to allow axial movement through a range of distances of the fluid transfer elements 140, for example distances of 1 mm to 10 mm, or distances of 3 mm to 7 mm. have. In some embodiments, the fluid delivery extension is limited to a maximum of 10 mm or 7 mm. The fluid transfer elements 140 may be advanced axially and/or radially. In some embodiments, the fluid transfer elements 140 are axially and radially advanced, for example to advance radially in proximity to the tissue and/or to advance radially into the tissue (e.g., penetrate into). Advance. Alternatively, the fluid transfer elements 140 are, for example, after the tissue has been pulled into the recess through a vacuum, into the protective recess, for example in the following Figures 5, 5A, 5B, 5C, 10 and 11 It may be advanced into the openings 131 described with reference to.

In some embodiments, one or more adjustable mechanical stops, such as an adjustable stop 118, configured to allow an operator to limit the advancement of the knob 112 relative to the right side of the page as shown. Buoys could be included. The handle 110 may include one or more markings corresponding to the movement of the fluid transfer elements 140 through the advancement of the knobs 112, the markings not shown. The magnitude of the advancement of the fluid transfer elements 140, both for linear distance as well as for radial displacement from the central axis, will be configured to expand the first tissue layer while avoiding expansion of the second deeper tissue layer. I will be able to. For example, fluid transfer elements 140 may be constructed and arranged and disposed to expand the first tissue layer while avoiding expansion of the second, shallower tissue layer. Fluid delivery elements 140 to penetrate tissue of various properties and shapes (e.g., in the form of a needle) and/or to allow fluid to penetrate into such tissue (e.g., in the form of a water jet). ) Could be constructed. In some embodiments, the fluid delivery element 140 is configured to penetrate the folds of the gastrointestinal tract.

The fluid transfer elements 140 may be of similar or different types, such as in an embodiment where the fluid transfer element 140a is a needle and the fluid transfer element 140b is a water sprayer. A plurality of fluid delivery elements 140 may be configured to deliver fluid simultaneously and/or sequentially. A plurality of fluid transfer elements 140 may be connected to individual supplies of fluid, such as fluid transfer tubes 121a and 121b to 121n, or one or more fluid transfer elements 140 may be described with reference to FIG. It may be attached to a single supply of fluid as described below.

The fluid transfer elements 140 are a symmetrical circumferential arrangement of fluid transfer elements, e.g., an arrangement of 2, 3, 4, 5, 6, 7, 8, 9 or 10 fluid transfer elements 140 May contain a sieve. In some embodiments, the fluid transfer elements 140 are a linear or axial arrangement of fluid transfer elements, for example 2, 3, 4, 5, 6, 7, 8, 9 or 10 fluid transfers. It may include an arrangement of elements 140. In some embodiments, a plurality of fluid transfer elements 140 may exist in an asymmetrical pattern, either at variable axial positions along device 100 or along a single circumference. The fluid transfer elements 140 are on or within two or more support arms of the inflatable assembly 130, such as the support arms, which are not shown but described in more detail below with reference to FIGS. 4 and 5, It could be placed one by one. Alternatively, a plurality of fluid transfer elements may be disposed on or within a single support arm. The arrangement of the plurality of fluid transfer elements 140 may be arranged in a helical pattern, and a pre-deployment and/or post-deployment helical pattern of the fluid transfer elements 140 which may be similar or different. Can include. Spiral patterns of fluid delivery elements 140 may be arranged to allow effective compression of the inflatable assembly 130, such that it may be inserted into a small lumen of a body access device, such as an endoscope. Arrangements of a plurality of fluid delivery elements 140 may be configured to deliver fluid simultaneously or sequentially. Fluid injections are a single injection at a single location; Multiple injections at a single location (eg, multiple injections without repositioning the assembly 130); Or may include multiple injections at multiple locations. Relocating the assembly 130 between injections may include rotation as well as axially advancing or retracting.

In some embodiments, a vacuum is applied to one or more of the handles 110 through a vacuum pump or other negative pressure source fluidly attached to the openings 131, for example through a connection 341 as shown. It is applied to the openings 131 through the vacuum supply source 340 connected to the internal components. Vacuum may be applied to one or more lumens of handle 110 and/or shaft 101, such lumens being fluidly connected to one or more lumens of connections 341, although not shown, These are then lumens that move distally so as to be fluidly connected to the one or more openings 131. Vacuum applied to the openings 131 or other openings of the inflatable assembly 130 or to other components of the device 100 may be used to maintain contact with the tissue and/or to manipulate the tissue. . In some embodiments, the applied vacuum is constructed and arranged to draw tissue into the openings 131, as described below with reference to FIGS. 5 and 10. Alternatively or additionally, vacuum source 340 may apply vacuum to one or more fluid transfer elements 140, e.g., vacuum is applied intermittently with one or more needles between fluid transfer periods. do. The vacuum source 340 may provide a fixed vacuum and/or the vacuum source 340 may provide a vacuum whose pressure or other performance parameters are adjustable by the operator. In some embodiments, the one or more controllers 111 may include a controller configured to connect the vacuum supply source 340 to the one or more openings 131. In a particular embodiment, the one or more controls 111 include a hole or other opening fluidly connected to the lumen that fluidly connects the vacuum source 340 and the one or more openings 131. This opening of the control 111 prevents any significant vacuum pressure from reaching the one or more connected openings 131. However, the covering of the openings of the control unit 111, such as by the operator's finger, causes the vacuum pressure to increase in one or more associated openings 131, and thus, for example, into one or more of these openings 131. Allows the organization to retreat.

In some embodiments, the assembly 130, one or more fluid transfer elements 140, and/or other components of the device 100 include flexible and radial supports that allow bending without luminal collapse, Thus, when one or more tissue layers expand, one or more fluid transfer elements 140 may automatically translate radially (eg, towards the center of the lumen). Alternatively or additionally, the assembly 130, one or more fluid transfer elements 140, such that when one or more tissue layers expand, be manually translated and/or radially compressed to similarly translate radially. ), and/or other components of the device 100 may be configured.

In some embodiments, fluid transfer is effected during advancing and/or retraction of one or more fluid transfer elements 140. Alternatively or additionally, after one or more fluid delivery elements 140 have been placed at the target tissue location, fluid delivery is effected. The fluid transfer elements 140 may include a needle, as disclosed in FIGS. 7, 8 and 9 and other figures described below; Water sprayer; Iontophoretic element; And/or combinations thereof. The fluid transfer elements 140 are shown in a retracted state in FIG. 1. A plurality of fluid transfer elements 140 and associated openings 131 may be evenly distributed along a relatively single axial position of the shaft 101. For example, two fluid transfer elements 140 may be separated by 180°, three fluid transfer elements 140 may be separated by 120°, and four fluid transfer elements 140 ) May be separated by 90°, five fluid transfer elements 140 may be separated by 72°, and so on. In alternative embodiments, one or more fluid transfer elements 140 and associated openings 131 may be separated at different angles of separation, in a single axial position (i.e., a single circumferential path), or a plurality of Can be arranged along the axial positions of.

Handle 110 may include or be attached to one or more sources of fluid, such as reservoirs 125 comprising reservoirs 125a and 125b to 125n as shown. The reservoirs 125 may include a fluid source, such as a liquid filled chamber, or have a port, such as a luer, for attachment to a source of fluid, such as a fluid filled syringe. 125 could include this. The fluid transfer elements 140a and 140b to 140n are fluidly connected to each of the fluid transfer tubes 121a and 121b to 121n, so that the fluid is transferred from each reservoir 125 to each associated fluid. It can be delivered to each individual fluid transfer element 140 via tube 121. Although fluid transfer tubes 121a and 121b to 121n are shown exiting the side of the handle 110, for example, exiting the distal end of the handle 110 to facilitate rotation of the handle 110 Alternative exit points, including those, may be used.

One or more fluids in numerous forms may be delivered through fluid delivery elements 140 to expand tissue. The fluid may comprise a liquid, a gas, or a combination of one or more liquids or gases. In some embodiments, the fluid to be injected is water; Saline solutions such as hypertonic saline; air; C0 ₂ ; One or more hydrogels; Epinephrine; Hypertonic glucose water; Hyaluronic acid; Glycerol solutions; And combinations thereof. In some embodiments, the fluid being injected contains a colorant or is otherwise configured to be visualized during injection, such as through an endoscopic camera or other visualization device so that tissue swelling can be quantified or otherwise assessed. Typical fluids to be visualized include, but are not limited to, methylene blue; dyes; Radiopaque fluid; MR visualizable fluid; Ultrasonically visible fluid; And combinations thereof. The injected fluid is a magnetic fluid; Hydrogel; A fluid configured to increase viscosity after injection; A fluid configured to reduce viscosity after injection; A fluid heated before injection, such as a mixture of glycerol and saline that is heated prior to injection; Fluids with a similar osmotic pressure to the tissue to be injected; A fluid configured to act as a thermal or electrical insulator; And combinations thereof. Colored (eg, non-transparent) fluids or colored fluids may be injected. In some embodiments, the color of the liquid changes due to a change in the temperature of the fluid, for example to assess the presence or amount of tissue swelling. In some embodiments, a first chromatic fluid is injected during a first injection and a second chromatic fluid is injected during a second injection, for example using the same or a different fluid delivery element. In some embodiments, the injected fluid may have a bioactive function, such as a vascular sclerotic; Anti-inflammatory; Antimicrotubule inhibitors or other mitosis inhibitors; Alkylating agents; Antimetabolite; Anthracycline; Plant alkaloids; Topoisomerase inhibitors; Anti-proliferative substances; And it provides a physiologically active function selected from the group consisting of combinations thereof.

The handle 110 may comprise or be attached to a functional element, such as the functional element 119 shown, comprising a functional element or assembly, the functional element comprising a vacuum source; Water pressure source; Pneumatic source; Sources of electrical energy such as batteries or radio frequency energy generators; A rotation drive mechanism such as a drive mechanism configured to rotate an imaging element such as an ultrasonic crystal or optical fiber; And combinations thereof. Functional element 119 may be made fluidly communicative, electrically or otherwise connectable to one or more components of the device, for example fluid delivery elements 140, inflatable assembly 130, openings. It may be connectable to the s 131 and/or other components of the device 100.

In some embodiments, device 100 includes: a pressure sensor; Force sensor; Strain gauge; electrode; Impedance sensor; Visualization sensors such as ultrasonic crystals, optically visible light, OCT or OCDR fibers; Optical sensor arrangements such as CCDs; Physiological sensor; Magnetic sensor; Optical sensor; And one or more sensors 135, such as one or more sensors selected from the group consisting of combinations thereof. In some embodiments, a pressure sensor is included, for example to monitor the pressure of tissue expansion. Diagnostic assembly integrated with one or more components integral to or external to handle 110, such as, for example, one or more electronic components configured to analyze a signal received from sensor 135 and generate a diagnostic output. Within, the sensor 135 is used to perform the diagnosis. The sensor 135 can determine the amount of tissue expansion; The amount of tissue swelling; Current tissue thickness (eg, before, during and/or after expansion); Tissue layer thickness; Depth of penetration of the fluid transfer element; Color density of the delivered fluid; Tissue impedance; The temperature of the tissue, such as the temperature of the tissue receiving the heated or cooled fluid through a needle such as needle 141 of FIGS. It is used to quantify or otherwise evaluate one or more of these combinations. Alternatively or additionally, the sensor 135 may include, for example, a heat converter, a cooling converter, a light source such as an LED; And a converter selected from the group consisting of combinations thereof.

The device 100 may be configured to advance through a separate body introduction device, for example an endoscope into which the device 100 is introduced through a lumen, also known as the "working channel" of the endoscope. In such embodiments, the device 100 may not include an outer sheath 109 and the shaft 101 may be fixedly attached to the handle 110. When or after the inflatable assembly 130 exits, respectively, the distal end of the endoscope, such inflatable assembly 130 may be automatically or manually inflated. The device 100 is introduced such that the fluid transfer elements 140 are positioned proximate one or more layers of tissue to be expanded, which tissue is, for example, tissue described below with reference to FIGS. 3A, 3B and 3C. . The shaft 101 may have a diameter configured to be inserted through a lumen of a limited size, for example the shaft is otherwise configured to be inserted through a lumen having a maximum diameter or a diameter of 6 mm or less. In some embodiments, for example, when the shaft 101 has a relatively continuous diameter of about 8 mm or less, the shaft 101 is inserted into the patient's anatomy along the side of the endoscope. In other embodiments, for example, when the shaft 101 has a relatively continuous diameter of about 13 mm or less, the shaft 101 is inserted into the anatomy of a patient without an endoscope.

Shaft 101 may include an insertable or “working” length configured to provide access to one or more body locations, such as one or more gastrointestinal body locations. In some embodiments, the device 100 is configured to expand tissue within the esophagus, and the shaft 101 is configured to be inserted through the mouth and has a working length of about 25 cm or more. In some embodiments, the device 100 is configured to expand tissue in the stomach, and the shaft 101 is configured to be inserted through the mouth and has a working length of at least about 35 cm. In some embodiments, the device 100 is configured to expand tissue within the duodenum, and the shaft 101 is configured to be inserted through the mouth and has a working length of about 100 cm or more. In some embodiments, the device 100 is configured to expand tissue within a jejunum, and the shaft 101 is configured to be inserted through the mouth and has a working length of at least about 140 cm. In some embodiments, the device 100 is configured to expand tissue within the ileum, and the shaft 101 is configured to be inserted through the mouth and has a working length of at least about 300 cm. The device 100 is, for example, as described below with reference to FIG. 10 through a lumen along most of the length of the shaft 101 (for example, as described below with reference to FIG. 4 ). ), or through a sidecar lumen configured for quick change guide wire delivery, may be configured for delivery across the guide wire. Device 100 may include, but typically, radiopaque markers, not shown; Electromagnetic markers; Ultrasonically identifiable markers; And one or more markers, typically one or more markers selected from the group consisting of combinations thereof.

Referring now to FIG. 1A, knobs 112 are shown, for example, in order to induce the fluid transfer elements 140a and 140b to 140n to exit individually through each of the openings 131a and 131b to 131n. As shown, it is advanced to the right side of the ground. In alternative embodiments, one or more knobs 112 are configured to advance two or more fluid transfer elements 140. For example, in order to control the depth of penetration of the fluid transfer element 140 into the tissue, the amount of expansion of each fluid transfer element 140 is manually and/or automatically adjusted by the amount of advancement of the knob 112. It will be able to be controlled. Handle 110 may include one or more markings, not shown but described to indicate axial advancement and/or radial displacement of each fluid transfer element 140. One or more needle stops may be included to ensure precise advancement of each fluid transfer element 140, and such needle stops are not shown but are the same as those described with reference to FIG. 10 below.

In some embodiments, the sheath 109, the shaft 101, the inflatable assembly 130, and/or the device ( 100) different components are constructed and arranged. Alternatively or additionally, components of the expandable assembly 130 and/or other device 100 may be constructed and arranged to compress radially as the tissue expands.

Turning now to Figure 2, a flow diagram of a method for tissue expansion, consistent with the concepts of the present invention, is shown. In step 200, a tissue expansion device of the concepts of the present invention is inserted into a patient, for example the patient undergoing a gastrointestinal diagnosis or treatment procedure. A tissue expansion device may be inserted through the lumen of a body access device, for example an endoscope. Alternatively or additionally, the tissue inflation device may be inserted across a guide wire, for example a guide wire through the lumen of the device, or across a quick exchange segment near the distal end of the tissue inflation device. .

In step 210, one or more fluid delivery elements of the tissue expansion device are placed near the tissue to be expanded. Such an arrangement may include a visualization device, for example an imaging device integrated into or inserted through the endoscope; An imaging assembly integrated into the tissue expansion device; An imaging device outside the patient such as a fluoroscope, a CT scanner, an MR scanner, and an ultrasound imaging device; An imaging device inserted into the patient, such as, for example, a visible camera and/or an ultrasound probe or catheter; And combinations thereof.

In step 220, an optional step in which one or more fluid transfer elements of the tissue expansion device are advanced, such advancement, for example, causes the one or more fluid transfer elements to contact the tissue and/or the outer layer of tissue. It is a step forward to infiltrate In some embodiments, one or more fluid transfer elements penetrate the mucosal tissue of the gastrointestinal tract and enter the submucosal layer, for example in a segment of the duodenum. In some embodiments, an inflatable assembly comprising one or more fluid delivery elements is typically inflated prior to or during the implementation of step 220 to contact lumen wall tissue, such as, for example, the lumen wall tissue of the duodenum. It will be possible. The inflatable assembly may be elastically deflected in a radially expanded state, for example a basket or cage that is elastically deflected to support one or more fluid transfer elements and are attached to the fluid transfer tubes. Alternatively or additionally, step 220 may include a tissue manipulation step, in which the tissue is moved, for example towards fluid transfer elements and/or into an opening. In some embodiments, a vacuum is applied to the port or other opening to draw tissue into the opening, as described below with reference to FIGS. 10, 10A and 10B. Once placed within the opening, the fluid delivery element can be advanced into the captured tissue and/or the fluid can be delivered to the captured tissue. For example, in order to preferentially move one or more inner layers of tissue into the opening while preventing one or more deeper layers from migrating into the opening, a vacuum applied to the specific tissue and the opening size is configured to preferentially move into the opening and Can be arranged. In some embodiments, the mucosa and submucosal tissue layers are drawn into the opening while the muscle layer is maintained outside the opening or otherwise disposed to prevent expansion by the fluid transfer element. Manipulation of one or more other tissues (eg, to “tent” the tissue) after the application of a vacuum, for example through advancing, retracting and/or rotating the tissue inflation device and/or components of the device. They will be able to be implemented

In step 230, one or more fluids are delivered into the tissue by one or more fluid transfer elements, causing one or more layers of tissue to expand. In some embodiments, one or more fluid transfer elements are moved (eg, advanced or retracted) during fluid transfer of step 230. Fluid is delivered to one or more fluid delivery elements through one or more fluid delivery tubes of the tissue expansion device. One or more fluid delivery tubes may be attached to one or more sources of fluids, for example one or more syringes, pumping assemblies and/or reservoirs of fluids.

In step 240, an optional step of assessing tissue swelling is performed. Tissue expansion assessment can be carried out using one or more visualization devices as described above, such visualization devices having a predetermined time after fluid injection, such as, for example, 10, 20 or 30 seconds after fluid injection is initiated or stopped. It is a device used in the visualization process carried out in In some cases, the visualization process may be performed at a time just prior to the implementation of the removal procedure, for example at 15, 30 or 45 minutes after fluid injection is started or stopped. If insufficient inflation has been achieved, an optional step 245 may be performed, where one or more fluid transfer elements are retracted and one or more portions of the tissue inflation device are relocated. Step 245 includes, but is not limited to, rotating the shaft of the fluid transfer device and/or the support structure comprising one or more fluid transfer elements; Advancing one or more fluid transfer elements axially and/or radially; Axially and/or radially retracting one or more fluid transfer elements; And various relocation adjustments including combinations thereof. Step 245 may further include advancing the fluid transfer elements, such as advancing previously described with reference to step 220, when one or more fluid transfer elements have previously been retracted during step 245. I will be able to. With the retraction and/or relocation of step 245 or without the retraction and/or relocation of step 245, step 230 is subsequently repeated, and one or more fluids are injected into the tissue to cause the Causes swelling. The optional step of step 240 can subsequently be repeated and assess the sufficiency of tissue expansion.

Step 250 is performed, with or without the evaluation performed in step 240 and/or the relocation performed in step 245, after fluid injection into the tissue in step 230. In step 250, as described, for example, by returning to step 210 and repeating steps 210 to 250, the fluid delivery device may be removed, at a later time or at a new time. It can be held in place for subsequent tissue expansion relatively immediately after it has been advanced to the tissue expansion position.

The methods of tissue expansion of the concepts of the present invention may include one fluid injection step, for example from one or more fluid transfer elements. Alternatively, tissue expansion may be effected in a plurality of fluid injection steps, such as a first injection at a first location, a second injection at a subsequent second location. The tissue expansion devices and their assemblies are typically configured to rotate, for example to inject into a plurality of tissue locations along a relatively uniform periphery of the lumen wall tissue. Fluid may be injected simultaneously and/or sequentially by a plurality of fluid delivery elements.

The fluid injected to cause tissue expansion may be a pre-determined volume, for example a pre-determined volume per injection and/or the cumulative volume of multiple injections delivered to a single location ( For example, it could be the amount of fluid delivered by the nozzle of the water injector for a single location or a single injection of a needle). In some embodiments, such a pre-determined volume of fluid per injection and/or location comprises a volume of 0.5 ml to 4.0 ml, or 1.0 ml to 3.0 ml. These pre-determined volumes may be injected at different locations, for example 2 to 10 locations along the relevant periphery of the lumen wall tissue. Complete tissue expansion may include one or more axial and/or circumferential injections, performed simultaneously and/or sequentially. The injections may be effected by one or more fluid transfer elements, for example by means of two or more fluid transfer elements delivering fluid simultaneously and/or sequentially. Between injections, the tissue expansion device can be axially advanced and/or retracted and can be rotated. In some embodiments, the fluid is delivered in the first position, causing the tissue to expand in the first inflation position. The second injection can be carried out in proximity to the first inflation position, for example close to the edge of the first inflation position. For ease of injection as well as to reduce the likelihood of failure of perforation or tissue expansion, repeated injections close to previously inflated locations are used.

Referring now to FIGS. 3A, 3B and 3C, a cross-sectional side view and an end view of a segment of luminal wall tissue, respectively, before, during and after overall circumferential tissue expansion, is shown, consistent with the concepts of the present invention. . In FIG. 3A, a side view and an end cross-sectional view of a segment of luminal wall tissue, prior to any expansion by the tissue expansion device of the concepts of the present invention, comprises an inner layer (L1), an intermediate layer (L2) and an outer layer (L3). do. In Fig. 3B, tissue swelling has occurred in a single location, within the tissue layer L2, towards the upper end of the ground as shown. In FIG. 3C, tissue expansion occurred for the entire 360° segment of layer L2. In some embodiments, a total or nearly total circumferential expansion (e.g., greater than about 300° of tissue expansion, greater than about 320° of tissue expansion, greater than about 330° of tissue expansion), for example, is a plurality of From fluid transfer elements, it was carried out in a relatively single step. In other embodiments, the total or nearly total circumferential expansion is, for example, from one or more fluid transfer elements configured to inject fluid in a first stage and rotate in one or more subsequent stages, into a plurality of stages. Is carried out, followed by injection of fluid into the tissue after each said rotation.

The expansion of the tissue layer, such as layer L2 in FIGS. 3A to 3C, is a reduction of up to 85% of the cross-sectional area before expansion (e.g., reduction of a 35 mm lumen to 30 mm lumen), or It may be practiced to cause a reduction in the cross-sectional area of the lumen, such as a reduction of 75%. Some body lumens comprise a non-smooth surface, for example an inner layer comprising a lining of the duodenum or jejunum comprising one or more folds known as corrugations. In some embodiments, tissue expansion is induced to smooth and/or widen folds such as wrinkles. This modification may be useful in the subsequent treatment of the inner lining of the lumen, thereby improving the results of one or more removal procedures, for example.

Numerous types and locations of patient tissue can be expanded by the devices, systems and methods of the inventive concepts. In some embodiments, the tissue to be expanded comprises submucosal tissue, such as the submucosal tissue of the duodenum. For example, the devices, systems and methods of the inventive concepts may be constructed and arranged to avoid expanding one or more layers of tissue when the serous layer or muscle layer of the duodenum is prevented from expanding. . Applicable tissue may include lumen wall tissue or other tissue layers. Applicable tissue locations for expanding include the gastrointestinal tissue layer; Duodenal tissue layer; Esophageal tissue layer; Factory tissue layer; Ileal tissue layer; Colon tissue layer; And a luminal wall structure selected from the group consisting of combinations thereof. Alternatively or additionally, the tissue for expansion may comprise a layer of gastrointestinal tissue; Bladder tissue layer; Oral tissue layer; Layer of uterine tissue; And a tissue selected from the group consisting of combinations thereof.

Turning now to FIG. 4, there is shown a side view of a distal portion of a tissue inflation device, including a manually deployable expandable assembly, consistent with the concepts of the present invention. A tissue inflation device, such as a tissue inflation device similar to device 100 of FIG. 1, includes an expandable assembly 130 in a pre-deployment (eg, prior to radial expansion) condition. The inflatable assembly 130 is shown axially to exit the sheath 109, for example through one or more controls on a handle mounted on the proximal end of the sheath 109. In some embodiments, the sheath 109 comprises the endoscope, for example when the inflatable assembly 130 is advanced through the working channel of the endoscope. The inflatable assembly 130 includes at least two support arms, arms 132a and 132b, and a tube that is typically hollow or partially hollow, such as a metal tube or a plastic tube. The arms 132a and 132b include openings 131a and 131b, respectively. The distal ends of the arms 132a and 132b are one or more controls on the proximal and extending proximal handle, such as described with reference to the handle 110 of FIG. 1 and configured to advance or retract the cable 103. Control cables, cables 103, typically metallic or non-metallic cables that are attached to them. The cable 103 may comprise a hollow tube, for example, a cable comprising a guide wire lumen 105, configured to allow transfer across the wires of the inflatable assembly 130 and sheath 109. have.

Two fluid transfer elements, needles 141a and 141b are shown disposed within arms 132a and 132b, respectively. Needles 141a and 141b typically comprise metallic needles, such as needles having a 20 to 35 gauge, or 23 to 27 gauge. The needles 141a and/or 141b may include a beveled end, for example an end having an inclination angle of 10° to 60°, for example an end having an inclination angle of about 30°. The needles 141a and 141b are fluidly attached to one or more fluid transfer tubes, such as the fluid transfer tubes 121 described with reference to FIG. 1, so that one or more fluids are attached to the needle through the fluid transfer tubes. It may be delivered to the s 141a and 141b. Needles 141a and/or 141b have special sharpness to prevent or minimize penetration of deeper tissue layers such as muscle or serous layers, while preferably penetrating one type of tissue, e.g., submucosal tissue. Or it could include other penetration properties. The needles 141a and/or 141b may be constructed and arranged to advance to an exposure length of less than 10 mm, for example less than 7 mm. The needles 141a and 141b may be configured and arranged to be held inside each of the openings 131a and 131b, as described below with reference to FIGS. 5 and 10. For example, a vacuum may be applied to the openings 131a and 131b to draw the tissue towards the openings 131a and 131b and/or into the openings 131a and 131b. Alternatively or additionally, the needles 141a and 141b may be configured and arranged to run out of the openings 131a and 131b, as described below with reference to FIG. 4B.

Referring now to FIG. 4A, the cable 103 has been retracted so that the intermediate portions of the arms 132a and 132b extend radially from the axis of the sheath 109. The openings 131a and 131b extend radially corresponding thereto as shown. The needles 141a and 141b are held in the illustrated pre-deployment position.

4B, when the needles 141a and 141b are advanced to exit the openings 131a and 131b, and thus the inflatable assembly 130 is placed against a tissue such as lumen wall tissue, Needles 141a and 141b penetrate into one or more layers of tissue. Advancement of the needles 141a and 141b may be made in combination or independently, for example through one or more controls on the proximal handle, as described with reference to the handle 110 of FIG. 1 but not shown. will be. In alternative embodiments, the needles 141a and 141b exit the openings 131a and 131b, respectively, during advancing, as described below with reference to the tissue expansion devices of FIGS. 5 and 10, for example. Does not come out. In these embodiments, a vacuum is applied to pull the tissue into the openings 131a and 131b, and the needles 141a and 141b, when advanced, penetrate the captured tissue.

Turning now to FIG. 5, a side view and an end view of a distal portion of a tissue expansion device, including a self-expanding assembly, are shown, consistent with the concepts of the present invention. A tissue inflation device, such as a tissue inflation device similar to device 100 of FIG. 1, includes an inflatable assembly 130 in a deployed (eg, radially inflated) state. The inflatable assembly 130 is advanced axially to exit the sheath 109, for example through one or more controls on a handle mounted on the proximal end of the sheath 109, the distal of the shaft 101. Attached to the end. In some embodiments, the sheath 109 comprises the endoscope, for example when the inflatable assembly 130 is advanced through the working channel of the endoscope. The inflatable assembly 130 includes at least three support arms, e.g., three support arms including proximal segments 133a, 133b and 133c, and attached distal segments 134a, 134b and 134c, respectively. Includes. Typically, the proximal segments 133a, 133b and 133c are hollow or partially hollow, such as a metal tube or a plastic tube, to receive the fluid transfer element in a sliding manner and the openings 131a, 131b and 131c, respectively. It is configured to include. The distal segments 134a, 134b and 134c are typically resiliently deflected in the orientation shown in FIG. 5, so that when not surrounded by a compression tube such as sheath 109, the inflatable assembly 130 Is induced to become a radially expanded condition. The inflatable assembly may be composed of an elastically deflected metal, such as stainless steel and/or nitinol, that is elastically deflected in an expanded or contracted geometry. In some embodiments, assembly 130 is configured to transition to a radially compressed state when inserted into a working channel of an endoscope and/or a lumen of a tube, such as, for example, sheath 109. The distal segments 134a, 134b and 134c may comprise an elastic, biocompatible material such as nitinol or stainless steel formed in a curved orientation. The distal segments 134a, 134b and 134c may comprise a flat sheet material or a round tube. A distal end of the distal segments 134a, 134b and 134c is attached to a proximal end 139, which surrounds and maintains the location of the distal end of the segments 134a, 134b and 134c. In alternative embodiments, the distal segments 134a, 134b and 134c may be manufactured as a single sheet or otherwise manufactured such that the distal ends of the distal segments are connected, with or without the leading end 139. The tip 139 may be covered by a non-traumatic material, such as silicone or other biocompatible polymer.

Each of the proximal segments 133a, 133b and 133c comprises a single fluid transfer element, needles 141a, 141b and 141c, respectively. The needles 141a, 141b and 141c are individually attached to a single fluid transfer tube 121a, 121b and 121c, respectively. In some embodiments, each fluid delivery tube to be attached to separate supplies of fluid for injection into tissue, such as reservoirs 125a, 125b and 125c, respectively described with reference to FIG. 1. Moves closer to the handle. In other embodiments, one or more fluid transfer tubes 121a, 121b and 121c are attached in fluid communication with each other, for example, to a source of fluid, such that the fluid is attached to one or more fluid transfer tubes 121a. , 121b and 121c). In some embodiments, as described below with reference to FIGS. 5A-5C, for example through a vacuum transfer tube, around each of the needles 141a, 141b and 141c, for example one or more openings. A vacuum is applied, for example through a proximal handle port, such as a vacuum applied at 131a, 131b and 131c. A vacuum applied is applied to maintain the tissue position during penetration of the tissue by the needles 141a, 141b and/or 141c, and/or to manipulate the tissue into the openings 131a, 131b and 131c for subsequent needle progression. It will be able to be configured. In some embodiments, a second opening is provided on one or more of the support arms 133a, 133b and/or 133c, the openings not shown, so as to be fluidly attached to a source of vacuum, and one or more forces into the tissue. Is configured to apply.

Referring now to FIG. 5A, there is shown a lateral cross-sectional view of a segment of a support arm of a tissue inflation device, consistent with the concepts of the present invention. The fluid transfer element is shown in the advanced position and the support member surrounds the fluid transfer element. A segment of the support arm 133 is shown, for example the proximal support arms 133a, 133b and/or 133c of FIG. 5 are shown. The support arm 133 comprises two lumens, namely lumen 107 and lumen 108, and a metal material such as stainless steel or nitinol having a diameter of 50D to 80D, or a plastic material such as Pebax®. , Rigid or flexible materials. The lumen 108 accommodates the needle 141 in a sliding manner. The distal end of the fluid transfer tube 121 is, for example, a sealed bond and/or frictionally coupled interface (e.g., between the proximal outer diameter of the needle 141 and the distal inner diameter portion of the tube 121 ). Interface), fluidly and mechanically attached to the proximal end of the needle 141. This attachment provides a fluid seal while allowing fluid to be delivered into the needle 141 through the fluid delivery tube 121. For example, the needle 141 is configured and arranged to advance into the opening 131, a recess in the support arm 133, up to the illustrated advanced position. The needle 141 may comprise a 25 to 30 gauge needle, for example a 27 gauge stainless steel needle having an inclined tip. The fluid transfer tube 121 may comprise a flexible shaft, eg, a shaft comprising a plastic material comprising a braid, eg, a polyimide shaft comprising a stainless steel braid.

At its proximal end, a lumen 107 is fluidly attached to an operator activatable vacuum source, such as, for example, vacuum source 340 of FIG. 1, although not shown. Lumen 107 is fluidly attached at its distal end to opening 131. The opening 131 may include sloped sidewalls 231, for example to induce the tissue to be drawn into the opening 131 to have a desired shape and/or a desired arrangement of tension vectors imparted to the tissue. I can. In use, the needle 141 is in a retracted state (eg, does not enter into the opening 131 ), and a vacuum can be applied to the opening 131. After the tissue is pulled into the opening 131, the needle 141 is advanced to the position shown in FIG. The fluid is prepared to be delivered through 121.

A support and/or guiding element, ferrule 149 may be included to provide support for the needle 141 when the needle 141 penetrates the tissue. The fitting tube 149 is configured to prevent undesired rotation, bending and twisting of the needle 141, for example when the needle 141 is advanced into the tissue. The fitting tube 149 may include a round tube that is bonded or frictionally coupled to the distal portion of the needle 141. The fitting tube 149 includes, for example, the fitting tube 149 from 0.020" to 0.036" (for example, a diameter close to 0.028"), and the lumen 108 from 0.027" to 0.043" (for example, For example, when including a diameter close to 0.035"), it may include an outer diameter that is close to the inner diameter of the lumen 108. The joint pipe 149 may include a tubular construct having a length of 1.5 mm to 2.5 mm, for example, a length approaching 2.0 mm. The fitting tube 149 may include a rigid material such as a metal such as stainless steel. The fitting pipe 149 may be disposed axially on the needle 141, and accordingly, when the distal end of the needle 141 moves axially to the position shown in FIG. 5A, most of the fitting pipe 149 It remains in the lumen 108.

Referring now to FIG. 5B, a top view of an opening in a support arm of a tissue expansion device, consistent with the concepts of the present invention, is shown, with the fluid delivery element in the advanced position. A segment of the support arm 133 is shown, for example, a segment of the proximal support arms 133a, 133b and/or 133c of FIG. 5, and/or a segment of the support arm 133 of FIG. 5A. The support arm 133 accommodates the fluid transfer tube 121 and the needle 141 in a sliding manner. The needle 141 is configured and arranged to be advanced into the recess in the support arm 133, the opening 131, for example to the advanced position shown. The opening 131 may include sloped sidewalls 231, for example to induce the tissue to be drawn into the opening 131 to have a desired shape and/or a desired arrangement of tension vectors imparted to the tissue. I can. For example, when the needle 141 is advanced through the tissue pulled into the opening 131, the relatively aligned (e.g., the support arm 133 and/or the center of the opening 131) shown in FIG. The needle 141 and the support shaft 133 can be constructed and arranged to maintain a position (aligned with respect to the axis). Alignment may be achieved through a needle support and/or alignment component, for example the fitting tube 149 of FIG. 5A. In some embodiments, when the needle 141 is fully advanced, the one or more needles 141 such that the opening in the distal end of the needle 141 is centered within the opening 131, as shown in FIG. 5B. And one or more components of the tissue expansion device, such as support arm 133 are constructed and arranged. Control of this arrangement can be achieved through the use of a needle stop, as described below with reference to FIG. 10, and/or for a handle such as handle 110 and associated controls described above with reference to FIG. 1. This can be achieved through one or more control units.

In some embodiments, the opening 131 comprises an axial length of about 4 mm, such that the residual length in the opening 131 when the needle 141 is fully advanced is 3 mm and the end of the needle 141 The needle 141 is constructed and arranged such that the inner opening is centered within the opening 131 as shown. In some embodiments, opening 131 comprises an axial length of up to 5 mm. In some embodiments, opening 131 includes a width of up to 2 mm.

Referring now to Fig. 5C, a perspective view of an alternative opening of a support arm, consistent with the concepts of the present invention, is shown. A segment of the support arm 133 is shown, such as a segment of the proximal support arms 133a, 133b and/or 133c of FIG. 5. The support arm 133 includes a lumen 108 configured to receive a fluid transfer element such as a fluid transfer tube and a needle in a sliding manner, with the fluid transfer tube and fluid transfer element not shown for clarity. The support arm 133 may comprise a diameter of 0.070" to 0.100", for example a diameter close to 0.090". The support arm 133 is a metal material such as stainless steel or nitinol, or a Pebax® material. May be constructed of a rigid or flexible material, such as a plastic material. Lumen 108 may comprise a circular cross-section, as shown in Figure 5C, and may have a diameter of, for example, 0.020" to 0.040", or It may comprise a circular cross section having a diameter of about 0.035". The support arm 133 further includes a lumen 107, which lumen is in fluid communication with a supply of vacuum pressure, such as vacuum pressure supplied by an operator adjustable vacuum source, such as vacuum source 340 of FIG. It is configured to be attached as possible. For example, in order to induce tissue to be drawn into the opening 131 ′, the lumen 107 may fluidly apply a vacuum to an opening or recess in the support arm 133, such as the opening 131 ′. do. The lumen 107 may comprise a crescent-shaped cross section, as shown in FIG. 5C. The opening 131' is additionally constructed and arranged to receive a fluid transfer element such as a needle.

The opening 131 ′ is an opening 131 ′, such as protrusions configured to limit the amount of tissue drawn into the opening 131 ′ when a vacuum is applied through the lumen 107 to the opening 131 ′. Includes protrusions 232 along the sidewalls of ). In some embodiments, one or more fluids delivered by a fluid delivery element such as a needle into the tissue induce tissue expansion within the submucosal tissue layer of gastrointestinal tissue, while expansion of deeper layers such as the muscle layer or serous layer. In order to avoid a problem, the protrusions 232 are constructed and arranged to allow sufficient pull of tissue into the opening 131 ′. Additionally, the opening 131 ′ is oblique walls 231, for example, in order to induce the tissue to be drawn into the opening 131 ′ to have a desired arrangement and/or a desired shape of the tensile force vectors imparted on the tissue. ).

Turning now to FIG. 6, there is shown a lateral cross-sectional view of a fluid transfer element comprising a permeator and a non-traumatic peripheral tube, consistent with the concepts of the present invention. The fluid transfer element 141 is disposed within the lumen of the tissue, such as the lumen of the duodenum or other gastrointestinal lumen. The tissue comprises a plurality of layers such as the innermost layer (L1), the deeper layer (L2) and the deeper layer (L3). In some embodiments, L1 includes a submucosal tissue layer, L2 includes a submucosal tissue layer, and L3 includes a muscle layer with or without an overlying serous layer. The fluid transfer element 141 is a round or other, slidingly receiving a sharp tube, a permeator 143, typically a hollow or solid tube, for example a metal hypotube having a sharp distal end. And a hollow tube 144 that includes a non-traumatic distal end 145. The tube 144 includes a hole in its wall, an opening 142 disposed at a relatively proximal end 145. Although not shown, as described above with reference to FIG. 1, the fluid flows through the tube 144 and the permeator, such as through one or more fluid delivery tubes, which are fluidly connected to the supply of fluid that is proximal and capable of being injected. The size of the tube 144 and the permeator 143 is determined so that it can be transmitted within the space between the 143. Fluid into the tissue through the opening 142 and/or out of the distal end of the tube 144, for example by a small expandable layer of deep tissue, for example when the distal end of the tube 144 is occluded. Can be delivered.

The fluid transfer element 141 is configured to allow initial penetration into the tissue by the permeator 143, as described and described below with reference to FIGS. 6A and 6B, and will be advanced into the tissue after such initial penetration. I can. In Fig. 6, the permeator 143 is advanced through the tissue layer L1 and into the tissue layer L2. While the permeator 143 is also advancing (as in FIG. 6), the injection of fluid during advancing of the tube 144 may be carried out, and the fluid preferentially exits through the port 142, and the layer ( L2) causes tissue expansion.

Referring now to FIG. 6A, the tube 144 has advanced past the permeator 143, through the tissue layer L1 and into the tissue layer L2. Through advancing of the tube 144 and/or retraction of the permeator 143, the permeator 143 is disposed, whereby the distal end of the permeator 143 is received within the tube 144, for example It prevents further advancement of the fluid transfer element 141 into a deeper layer of tissue, such as into the tissue layer L3.

Referring now to FIG. 6B, the fluid between the permeator 143 and the tube 144, for example, to exit the distal end 145 of the tube 144 and/or pass through the opening 142. It is injected into the space, causing the tissue layer (L2) to expand.

Referring now to FIG. 7, there is shown a lateral cross-sectional view of a fluid transfer element comprising a needle having an inner lumen, consistent with the concepts of the present invention. The fluid delivery element 140' is located within the lumen of the tissue, such as the lumen of the duodenum or other gastrointestinal lumen. The tissue comprises a plurality of layers, for example an innermost layer (L1), a deep layer (L2), and a deeper layer (L3). The fluid transfer element 140 ′ includes a needle 141, which includes a lumen 147. The needle 141 includes a sharp distal tip 146 that typically includes an angled end, and as described above with reference to FIG. 1, for example through one or more controls on the proximal handle, the shaft 101 It may be configured to be advancing from For example, to cause the needle 141 to be rotated (e.g., to create a full or nearly full circumferential tissue expansion, e.g., to conduct a plurality of fluid delivery events around the periphery of the tissue) For example, when retracted) can be constructed and arranged. Lumen 147 is fluidly connected to one or more fluid transfer tubes, not shown, but which move proximally and are fluidly connected to a source of injectable fluid. As described above with reference to FIG. 1, fluid may be delivered to the tissue out of the distal end 146 of the needle 141, for example through one or more controls on the proximal handle or on a device connected to the proximal handle. .

Turning now to FIG. 8, there is shown a lateral cross-sectional view of a fluid transfer element comprising a water jet including a nozzle and an inner lumen, consistent with the concepts of the present invention. The fluid transfer element 140" is positioned within the lumen of the tissue, such as the lumen of the duodenum or other gastrointestinal lumen. The tissue comprises a plurality of layers, for example the innermost layer (L1), the deep layer (L2), and It comprises a deeper layer L3. The fluid transfer element 140" comprises a nozzle 148 fluidly connected to the lumen 147. Nozzle 148 is one or more tissue surfaces, for example, when a water nozzle is used in Erbejet 2 manufactured by Erbe Elektromedizin GmbH, Tubingen, Germany, for example to deliver fluid to a layer of deep tissue. It can be configured to allow high pressure delivery of fluid, i.e. the inject 150, shown as a collimated stream having sufficient pressure to penetrate them. The nozzle 148 may be configured such that it can be made advancing from the shaft 101, for example through one or more controls on the proximal handle, as described above with reference to FIG. 1. The nozzle 148 can be configured and arranged to rotate, for example to effect a plurality of fluid delivery events around the periphery of the tissue, for example to create a full or nearly full circumferential tissue expansion. Although the nozzle 148 is shown in an orientation along the axis of the shaft 101, the nozzle 148 will be oriented off-axis, such as an angle of 1° to 179°, typically 10° to 170°. I can. Although nozzle 148 is shown as a single nozzle, multiple nozzles may be employed. Lumen 147 is fluidly connected to one or more fluid transfer tubes, not shown, but fluidly connected to a supply of proximal and injectable fluid. The fluid may be delivered from the nozzle 148 to the tissue, for example through one or more controls on the proximal handle or on a device connected to the proximal handle, as described above with reference to FIG. 1.

Referring now to FIG. 9, a lateral cross-sectional view of a fluid delivery element including an iontophoretic fluid delivery system is shown, consistent with the concepts of the present invention. The fluid transfer element 140"' is positioned within the lumen of the tissue, such as the lumen of the duodenum or other gastrointestinal lumen. The tissue comprises a plurality of layers, for example the innermost layer (L1), the deep layer (L2), And a deeper layer L3. The fluid transfer element 140"' comprises an iontophoretic transfer element comprising a reservoir 151 and an electrode 152. The storage container 151 is connected to the lumen 147 in fluid communication. The storage container 151 and electrode 152 may be configured to be capable of being advanced from the shaft 101, for example through one or more control units on the proximal handle, as described above with reference to FIG. 1. Reservoir 151 can be configured and arranged to rotate, for example to effect a plurality of fluid delivery events around the periphery of the tissue, for example to create a full or nearly full circumferential tissue expansion. Lumen 147 is fluidly connected to one or more fluid transfer tubes, not shown, but fluidly connected to a supply of proximal and injectable fluid. The electrode 152 is connected to one or more wires, not shown, but moving proximally to a control unit configured to induce the electrode to apply an electric field into and/or around the storage container 151 . Although electrode 152 is shown as a single electrode, multiple electrodes could be employed. The implant 150 contains an ionic fluid that can be driven into at least the tissue layers L1 and L2 by the electric fields generated by the electrode 152, for example through iontophoretic transfer well known to those skilled in the art. Includes. Activation of electrode 152 may be accomplished through one or more controls on the proximal handle or on a device connected to the proximal handle, as described above with reference to FIG. 1.

Referring now to FIG. 10, a lateral cross-sectional view of a distal portion of a tissue inflation device comprising a side recess portion and a protected needle exit port is shown, consistent with the concepts of the present invention. The device 100 includes a shaft 101 having an integral side car 106, disposed at or near the distal end 102 of the shaft 101. The side car 106 includes a guide wire lumen 106 ′, whereby the shaft 101 can be advanced and/or exchanged for a guide wire via a quick exchange transfer, as known to those skilled in the art. have. The shaft 101 further comprises two lumens, the first lumen 108 is capable of receiving the fluid transfer element, i.e., the needle 141 in a sliding manner, and the second lumen 107 to convey the vacuum. It is composed. The shaft 101 includes a recess in its sidewall, and the recess 155 is relatively proximate to the distal end 102 of the shaft 101. The recess 155 may be disposed within a lumen of a tissue, such as a lumen of the duodenum or other gastrointestinal lumen, to expand one or more layers of tissue, such as, for example, a layer of submucosal tissue of the duodenum. The opening 158 is disposed within the lumen 107 and the recess 155, and accordingly, as described below with reference to FIGS. 10A and 10B, for example to draw the tissue into the recess 155 , The applied vacuum may be introduced into the recess 155 through the lumen 107.

The needle 141 is capable of fluid communication with one or more fluid transfer tubes, such as one or more fluid transfer tubes, not shown, in fluid communication with a supply of fluid, as described above with reference to the device 100 of FIG. 1 It includes a lumen 147 connected to each other. The needle 141 is, for example, through one or more controls on the proximal handle, as described above and with reference to FIG. 1, for example to have a distal end exit lumen 108 and an entry recess 155. , It is configured to be advancing along the axis of the shaft 101 and the lumen 108. A mechanical stop 157 is disposed within the lumen 108. The collar 156 is attached to the needle 141, and thus, when the collar 156 contacts the mechanical stop 157, the advancement of the needle 141 is limited. In some embodiments, the collar 156 and/or stop 157 may be used, for example through one or more controls disposed on the proximal handle, to adjust the permitted movement of the needle 141. The position can be adjusted. In some embodiments, in order to prevent the needle 141 from exiting the device 100 when the needle 141 begins to be detached, the needle 141 is made longer than the axial length of the recess 155. The length of the needle 141 is selected.

In some embodiments, device 100 includes an imaging component, i.e., a visualization element 165 connected to cables 166. The imaging component 165, although not shown, is configured to present an image to the operator, for example through one or more visible displays, disposed in the field of view of one or more operators of the device and connected to cables 166. The imaging component 165 includes an ultrasonic imaging device; Optical coherence domain reflectometry (OCDR) imaging device; Optically correlated tomography (OCT) imaging device; Confocal microscopy endoscopy through scanning or structured illumination; It may include an imaging element selected from the group consisting of combinations thereof. Cables 166 may include electrical wires, optical fibers and/or one or more rotating shafts, for example to provide power or otherwise enable imaging component 165 to provide an image. I will be able to. Images provided by imaging component 165 may be used to determine the sufficiency of tissue expansion caused by delivering fluid through needle 141 to one or more layers of tissue, or otherwise assess.

Referring now to FIG. 10A, the distal portion of the shaft 101 and the recess 155 have been disposed proximate to tissue, such as gastrointestinal tissue, for example a vacuum source attached to and/or within the proximal handle Through, vacuum was applied through port 158 and lumen 107 into the recess. As a vacuum is applied, tissue proximate to recess 155 is drawn into recess 155 as shown in FIG. 10A. In some embodiments, recess 155 includes a geometry and size to precisely induce tissue expansion of certain layers of the intestinal anatomy. For example, the recess 155 may not include a muscle layer, but may include a geometry and size to induce a mucosal layer (< 1 mm thick) to enter the recess 155. In these embodiments, as the tissue is drawn into the recess 155, the spongy submucosal tissue layer stretches and enlarges, thus creating a larger target for needle 141 insertion. By using minimizing the width of the recess 155, it is possible to prevent the entire thickness of the tissue from being pulled into the recess 155 by the vacuum applied through the lumen 107. In some embodiments, the recess 155 comprises a width of less than 2.0 mm, such as less than 1.5 mm or less than 1.0 mm. Using minimizing the axial length of the recess 155, for example, when the distal end of the recess 155 provides a normal force in response to tissue penetration of the needle 141, into the recess 155. Penetration of the needle 141 into the pulled tissue can be improved. In some embodiments, the recess 155 is less than 5.0 mm long, for example less than 4.0 mm or 3.0 mm long. In some embodiments, the recess 155 includes a width close to 1.5 mm and a length close to 4.0 mm. In some embodiments, lumen 107 and needle 141 are each contained within a single tube, such as a double lumen tube as described above with reference to FIG. 5C.

Referring now to FIG. 10B, as shown, the needle 141 has been advanced axially into the tissue while maintaining a vacuum within the lumen 107. Advancement of the needle 141 may be achieved by one or more controls on the proximal end of the shaft 101, such as controls integrated into the handle, as described with reference to the handle of FIG. 1. It is received in recess 155 after insertion of the needle into tissue, for example through fluid delivery tubes that move proximally to one or more sources of fluid on the proximal end of shaft 101. In some embodiments, the distal end of the needle 141 is sized and so configured to limit the travel distance between the location where the tip of the needle 141 enters the recess 155 and the location where the needle 141 first penetrates the tissue. Minimizing this distance may prevent agglomeration or stretching of the tissue or may otherwise improve the penetration of the needle 141 into the tissue trapped within the recess 155.

The shaft 101 and recess 155 of FIGS. 10, 10A and 10B can be configured and arranged to rotate. In these embodiments, in order to pull a series of tissue sections into the recess 155 through a vacuum, then a plurality of the needles 141 are advanced and fluid is delivered, e.g., full or nearly full circumferential tissue expansion. In order to create a plurality of fluid delivery events can be conducted around the periphery of the tissue.

Referring now to FIG. 11, there is shown a lateral cross-sectional view of a distal portion of a tissue inflation device comprising an end recess portion and a protected needle exit port, consistent with the concepts of the present invention. Except that the recessed portion 155' is disposed at the distal end 102 of the shaft 101', the shaft 101' and the recessed portion 155' are the shaft 101 and recessed in FIG. Similar to (155).

The shaft 101 ′ further includes a fluid transfer tube 121 and a first lumen 108 for receiving the fluid transfer element, that is, the needle 141 in a sliding manner. The shaft 101' further includes a second lumen 107 configured to convey a vacuum. Recess 155 ′ and lumen 107 to pull tissue into recess 155 ′ and to apply tension to this tissue to resist forces encountered during penetration of the tissue by needle 141. It is constructed and arranged.

The recess 155 ′ may be located within the lumen of the tissue, such as the lumen of the duodenum or other gastrointestinal lumen, to expand one or more layers of tissue, such as the submucosal tissue layer of the duodenum. The opening 158' is disposed between the lumen 107 and the recess 155', and the vacuum applied accordingly can be introduced into the recess 155' through the lumen 107, and accordingly, FIG. As described above with reference to 10a and 10b, the tissue is pulled into the recess 155'.

The needle 141 is a lumen 147 fluidly connected to a fluid delivery tube 121 to which a proximal end thereof is attached to one or more supplies of fluid, as described above with reference to the device 100 of FIG. 1. ). The needle 141 is, for example, through one or more controls on the proximal handle, for example to exit the lumen 108 and enter the recess 155 ′, as also described above with reference to FIG. 1. It is configured to be capable of advancing along the axis of the shaft 101' and the lumen 108. In typical use, the distal end 102 of the shaft 101 is placed proximal to the tissue, a vacuum is applied through the opening 158', after which the needle 141 is advanced into the capture tissue and one or more fluids are removed. It is injected into the tissue through lumen 108 and fluid transfer tube 121 to cause one or more layers of tissue to expand.

Referring now to FIG. 12, a lateral cross-sectional view of a distal portion of a tissue inflation device comprising an endoscope and an advanceable needle is shown, consistent with the concepts of the present invention. The endoscope 170 is advanced through the lumen tissue, eg, through the gastrointestinal tract, eg, to a location within the duodenum. The tissue comprises a plurality of layers, for example an innermost layer (L1), a deep layer (L2), and a deeper layer (L3). The endoscope 170, through one or more steering controls common to the endoscopic devices, has a deflected distal end, so that the needle 141 is able to avoid penetration of the layer L3, while avoiding penetration of the layers L1 and L2 of the tissue. ) Can be advanced axially to penetrate, thereby penetrating the mucosa and submucosal tissue layers of the gastrointestinal tract, avoiding penetration of deeper layers such as the serous membrane.

The needle 141 including the lumen 147 may be configured to be able to be advanced from the working channel 172 of the endoscope 170, for example through one or more control units. For example, such that the endoscope 170 is rotated (e.g., needle 141 When) is retracted) can be constructed and arranged. The needle 141 and the lumen 147 are fluidly connected to the fluid transfer tube 121 (eg, hypotube) through the bond joint 122. The lumen 147 is attached in fluid communication to the lumen 147' of the fluid transfer tube 121. In some embodiments, the lumen 147 ′ has a larger diameter than the lumen 147 as shown in FIG. 12 and thus, for example, provides the pressure required to deliver the fluid through the fluid delivery tube 121. Decrease. The fluid delivery tube 121 moves proximal and is fluidly connected to a supply of injectable fluid, such as a syringe or pumping assembly. The fluid may be delivered to the tissue out of the distal end of the needle 141, for example through one or more controls on the proximal handle or on a device connected to the proximal handle, as described above with reference to FIG. 1.

In some embodiments, the needle 141 and/or the fluid transfer tube 121 includes a flexible and radial support that allows for flexion without luminal collapse, so that the needle 141 is a tissue layer (L2). When it expands, it can translate toward the center of the lumen.

The endoscope 170 includes a camera 171 arranged to allow the operator to visualize the penetration of the needle 141 into the tissue as well as the expansion of one or more tissue layers, such as the illustrated layer L2. In some embodiments, the injected fluid includes a dye or other visualizable colorant that can be used to quantify or otherwise evaluate the amount of tissue swelling (e.g., visualize deeper color at a given location). The more it becomes, the thicker the swelling at that location). Alternatively or additionally, the endoscope 170 may include another visualization device, such as an ultrasonic imaging device; Optically correlated interferometer (OCDR) imaging device; Optically correlated tomography (OCT) imaging device; And other imaging devices, such as a device selected from the group consisting of combinations thereof. For example, in order to transmit visible light and/or infrared light, the endoscope 170 may further include a light source such as an LED 173. The endoscope 170 further includes a second working channel 174, such as a working channel sized for receiving a tissue manipulating device in a sliding manner, such as a tissue manipulating device as described below with reference to FIG. 18. Can include.

Referring now to FIG. 13, a side view of a distal portion of a tissue expansion device including a plurality of needles and a fluid distribution manifold is shown, consistent with the concepts of the present invention. The inflatable assembly 130 is shown distal to the distal end 102 of the shaft 101. The inflatable assembly 130 includes at least three support arms, for example the shown support arms 132a, 132b, 132c. The support arms 132a, 132b, 132c may be elastically deflected in the radially expanded condition shown in FIG. 13. In some embodiments, the inflatable assembly 130 is received in a sliding manner by the shaft 101, so that the retraction of the inflatable assembly 130 into the shaft 101 causes the inflatable assembly 130 to Induces it to be compressed radially. In other embodiments, for example, when the expandable assembly 130 is inserted through the endoscope in which the working channel of the endoscope radially compresses the expandable assembly, the expandable assembly 130 is fixed relative to the shaft 101. It will be possible. The tip 139 may be connected and/or enclosed to the distal ends of the support arms 132a, 132b, and 132c, and the tip 139 may be non-elastomeric or other relatively soft material. It may include traumatic covering. In an alternative embodiment, the inflatable assembly 130 includes two support arms, such as two support arms 132a and 132b disposed 180° from each other.

Each of the support arms 132a, 132b, and 132c includes openings, that is, openings 131a, 131b, and 131c that individually face radially outwardly. The fluid transfer element, for example needles 141a, 141b, and 141c, is received in a sliding manner by arms 132a, 132b, 132c, respectively. The needles 141a, 141b, and 141c are configured and arranged to be advancing to the outside of the openings 131a, 131b, 131c, respectively, as described in detail above, for example.

The needles 141a, 141b, and 141c are individually attached to the fluid transfer tube, ie to the fluid transfer tubes 121a, 121b, and 121c, respectively. Fluid delivery tubes 121a, 121b, and 121c are fluidly attached to a fluid distribution manifold, i.e., valve assembly 160, and the valve assembly is again in fluid communication with a single fluid transfer tube, i.e., lumen 108. Attached as possible. Lumen 108 moves proximally and, as specifically described above, is fluidly connected to one or more sources of injectable fluid.

Referring now to FIG. 13A, an enlarged cross-sectional view of the valve assembly 160 of FIG. 13 is shown, consistent with the concepts of the invention. The valve assembly 160 has its proximal end connected to the lumen 108. The valve assembly 160 includes three sets of solenoids and pistons, including solenoids 161a, 161b, and 161c, which advance and retract the pistons 162a, 162b, and 162c, respectively. Pistons 162a, 162b, and 162c are disposed within fluid transfer tubes 121a, 121b, and 121c, for example to induce the flow path between each tube and lumen 108 to be open or closed. . The distal ends of the cables of the wires 163 are attached to the solenoids 161a, 161b, and 161c. The wires 163 move distally, e.g., contained within the handle and allow the operator to independently guide the fluid to flow into all or any of the fluid delivery tubes 121a, 121b, and 121c. Control circuitry that is configured to allow.

Referring now to FIG. 13B, an enlarged cross-sectional view of the support arm of FIG. 13 is shown, consistent with the concepts of the present invention. The support arm 132a includes a proximal segment 133a configured to receive a fluid transfer element, i.e., a needle 141a in a sliding manner, and includes an opening 131a. Needle 141a and attached fluid delivery tube 121a, via one or more controls on the proximal handle, such as handle 110 of FIG. 1, configured to allow an operator to advance needle 141a, for example. Is advanced. In some embodiments, as the needle 141a is advanced, one or more layers of tissue, such as, for example, one or more layers of gastrointestinal tissue, with a lamp 136a disposed proximate to the opening 131a. Contact with a hard surface configured to orient the needle 141a at a pre-determined trajectory to penetrate them.

Referring now to FIG. 14, a lateral cross-sectional view of a distal portion of a tissue expansion device comprising a spring-loaded needle injector is shown, consistent with the concepts of the present invention. The shaft 101 includes a distal end 102 and surrounds a fluid transfer element, such as a needle 141. An injection assembly 190 is included to allow the operator to induce advancement of the spring-forced needle 141, for example an automated advancement of a predetermined distance and/or a pre-determined force into the tissue, and It is composed. An operative mechanical stop, ie, protrusion 197, attached to the inner wall of the shaft 101 may be included.

The injection assembly 190 includes a spring 191 attached to the needle 141 on one end and to the inner wall of the shaft 101 on the other end. The spring 191 is arranged to apply a forward force (ie, to the left of the ground as shown) onto the needle 141 when the needle 141 is in the retracted state shown in FIG. 14. The injection assembly 190 further includes a latching assembly 193 comprising a control rod 194 attached to one end of the biasing spring 192. The other end of the biasing spring 192 is attached to the inner wall of the shaft 101, thereby creating a biasing force onto the rod 194, for example towards the left side of the ground as shown. The control rod 194 moves proximally and is typically attached to the forward and retract controls on the handle on the proximal end of the shaft 101, as specifically described above with reference to FIG. 1. The control rod 194 is engageable with the pivoting latch 195, which releasably engages the radially extending portion of the needle 141, that is, the protrusion 196. When disposed as shown in FIG. 14, the pivoting latch 195 has a protrusion 196 that prevents the spring 191 from advancing the needle 141 out of the distal end 102 of the shaft 101. Force is applied to the needle 141 through.

Referring now to FIG. 14A, the control rod 194 is retracted, pivoting the pivoting latch 194 and inducing a release engagement with the protrusion 196. The force applied by the spring 191 induces the needle 141 to advance to the left side of the ground as shown. In some embodiments, a mechanical stop, ie, a protrusion 197 is included, to direct the needle 141 to advance a maximum distance, for example the target tissue layer and/or the target tissue depth. After advancing, as specifically described above, one or more fluids may be delivered to one or more tissue layers.

In some embodiments, for example, when received in a sliding manner by a slot and fixing mechanism, each not shown but configured to allow operator adjustment of the position of the protrusion 197, the protrusion 197 is the shaft 101 Can be moved along the axis of. For example, as specifically described above, by one or more controls on the proximal handle, subsequent retraction of the needle 141 causes the injection assembly 190 and the latching assembly 193 to be reset to the condition shown in FIG. 14. , Preparation for repositioning of the device, and spring-loaded advancement of the needle 141 into the tissue to support tissue expansion through fluid delivery. The injection assembly 190 may be included in one or more of the tissue expansion devices described herein, thereby allowing, for example, automated fluid delivery advancement, such as advancement of the needle 141 and/or Allows for a controlled force of tissue penetration and/or a controllable advance distance.

Turning now to FIG. 15, there is shown a lateral cross-sectional view of a distal portion of a tissue expansion device including a needle deflected in a retracted state, consistent with the concepts of the present invention. The shaft 101 includes a distal end 102 and surrounds a fluid transfer element such as a needle 141. The biasing assembly 198 includes a spring 199 having one end connected to the needle 141 and the other end connected to the inner wall of the shaft 101. The spring 199 is attached and oriented to provide a biasing force that causes the needle 141 to be in a retracted position, such as the retracted position shown in FIG. 15.

Referring now to Fig. 15A, the needle 141 has been advanced (to the left of the ground as shown), for example, through one or more controls contained within the proximal handle, as specifically described above. The spring 199 is extended to place a biasing force that tends to induce the needle 141 to be retracted. The deflection assembly 198 may be included in one or more of the tissue expansion devices described herein, such that, for example, the operator may unintentionally leave a fluid delivery element such as needle 141 in an advanced position. You will be able to prevent it.

Referring now to FIG. 16, there is shown a cross sectional view of a fluid delivery element including a lumen closure assembly and a needle, consistent with the concepts of the present invention. A fluid transfer element, i.e., the needle 141, is located within the lumen of the tissue, such as the lumen of the duodenum or other gastrointestinal lumen. The tissue comprises a plurality of layers, for example an innermost layer (L1), a deep layer (L2), and a deeper layer (L3). The side outlet port, i.e., the needle 141 comprising an opening 142 fluidly attached to the lumen 147, is, as described above with reference to FIG. 1, through one or more controls on the proximal handle, for example. , It may be configured to be advancing from the shaft 101. The shaft 101 can be configured and arranged to rotate (e.g., when the needle 141 is retracted), thereby conducting a plurality of fluid delivery events, for example around the periphery of the tissue, Thus, for example, it is possible to create a full or nearly full circumferential tissue expansion. Lumen 147 is fluidly connected to one or more fluid transfer tubes, not shown, but moving proximally and fluidly connected to a supply of injectable fluid. Fluid can be delivered to the tissue out of the distal end of needle 141, for example through one or more controls on the proximal handle or on a device connected to the proximal handle, for example as described above with reference to FIG. 1.

An assembly for completely or partially occluding the lumen, i.e., the obturator assembly 180 is disposed relatively near the needle 141, for example, one or more fluids in the lumen surrounded by the layer L1 accordingly (e.g. For example, obstructing the flow of insufflation fluids) and/or fluid in one or more tissue layers (L1, L2, and/or L3) (e.g., fluid injected by needle 141, It obstructs the flow of blood, and/or other fluids in the layers (L1, L2, and/or L3). The occlusion assembly 180 may be made inflatable, for example, through delivery of one or more fluids, such as _{air, CO 2 and/or saline, through the inflation tube 181 into the balloon 182.} ), such as. The inflation tube 181 moves proximally and is connected to an inflation port or other supply of fluids, for example on a handle as described above. In Fig. 16, the balloon 182 still has to be inflated, and the needle 141 has not yet penetrated the tissue layer L1. In alternative embodiments, the closure assembly 180 may include another inflatable element, for example an inflatable cage or basket configured to apply force to one or more layers of tissue.

Referring now to FIG. 16A, balloon 182 is inflated and contacts tissue layer L1, for example in full or partial circumferential contact. The level of swelling may be selected to compress one or more tissue layers, such as L1, L2, and/or L3, as shown.

Referring now to FIG. 16B, the needle 141 has been advanced through the tissue layer L1 and into the tissue layer L2 and the opening 142 has been placed in the tissue layer L2. Balloon 182 remains in its inflated state.

Referring now to FIG. 16C, fluid has advanced through opening 142 into tissue layer L2, and tissue layer L2 has been induced to expand as shown. Maintaining the balloon 182 in an inflated state reduces and/or prevents the movement of fluid past the location of the balloon 182, so that, for example, the expansion of the tissue, as shown in the ground of the figure. As such, the expansion of the tissue is directed in the circumferential direction and/or in the direction to the right side of the balloon 182

Although the balloon 182 is shown distal to the location of penetration of the needle 141 into the tissue, in an alternative method, the balloon 182 may be disposed proximal to the needle 141. Although the obturator assembly 180 is shown as having a single balloon 182, in alternative embodiments, a plurality of balloons or other inflatable elements may be included, for example the location of penetration of the needle 141. May be disposed distal and/or proximal to the. In embodiments of such a plurality of balloons, a fluid transfer element such as a needle 141 may be configured to deploy between the first balloon and the second balloon.

Referring now to FIG. 17, a distal portion of a tissue inflation device comprising a fluid delivery element having an operator adjustable needle trajectory guide is shown, consistent with the concepts of the present invention. The shaft 101 includes a distal end 102 and an opening 142 adjacent the distal end 102. The shaft 101 surrounds a fluid transfer element, i.e., a needle 141, configured to be advanced into one or more tissue layers to support fluid delivery to expand the one or more tissue layers. The needle 141 passes through the needle guide assembly 115. The needle guide assembly 115 comprises a needle guide 117, typically a metal or other rigid material, configured to receive the needle 141 in a sliding manner and to direct the distal portion of the needle 141 into tissue. do. The needle guide assembly 115 further includes a pivot point, i.e., a pin 116, which is received in a sliding manner by the guide portion 117 and through which the needle guide portion 1170 can pivot. The portion 117 is attached to the cable 104, which moves proximally to the control, i.e., not shown, but typically moves proximally to the operator control on the handle configured to advance and/or retract the cable 104. The cable 104 can be advanced and/or retracted to induce the needle guide 117 to pivot, and thus, for example, the trajectory at which the needle 141 exits the opening 131 of the shaft 101 In Fig. 17, the cable 104 and the needle guide 117 are arranged such that the needle 141 exits the shaft 101 at about 90°.

Referring now to FIG. 17A, the cable 104 has been retracted and the trajectory taken by the needle 141 is directed towards the distal end 102 of the shaft 101.

Now, referring to FIG. 17B, the cable 104 has been advanced, so that the trajectory taken by the needle 141 is away from the distal end 102 of the shaft 101 (e.g., the proximal of the shaft 101 To the end).

Referring now to FIG. 18, a lateral cross-sectional view of a fluid transfer element comprising a needle having a side hole is shown, consistent with the concepts of the present invention. The needle is advanced to penetrate into the second layer of the body lumen. The fluid transfer element, as shown, includes a solid tip, a lumen 147, and a needle 141 comprising a side hole, i.e., an opening 142. Lumen 147 is fluidly connected to one or more fluid transfer tubes, not shown, but moving proximally and connected to a fluid transfer assembly, such as the fluid transfer assembly 330 disclosed herein. The fluid delivery assembly 330 is configured to deliver one or more fluids, as described above. The shaft 101 includes a lumen 108 through which the needle 141 is advanced in a sliding manner. In some embodiments, the lumen 108 and/or the lumen of the other shaft 101 is fluidly attached to a source of vacuum, for example to the vacuum source 340 described above. Vacuum source 340 may be set to a pre-determined vacuum pressure and/or vacuum source 340 may be operator adjustable. In FIG. 18, for example, the needle 141 and the shaft 101, not shown but described herein with reference to other embodiments, through the working channel or other body access device of the endoscope, or across a guide wire. Was inserted into the body lumen containing layers L1, L2, and L3. The needle 141 has been advanced into the tissue layer L2. As the needle 141 is advanced into the tissue, a vacuum may be applied to the lumen 108 by a vacuum source 340.

Referring now to FIG. 18A, fluid was injected from the fluid delivery assembly, through lumen 147 and openings 142, thereby inducing expansion of tissue layer L2. During injection, a vacuum may have been applied to lumen 108 through vacuum source 340.

Now, referring to FIG. 18B, the tissue manipulation assembly 175 has been introduced into a position close to the tissue penetration position of the needle 141. The tissue manipulation assembly 175 comprises an elongated tube, i.e. a shaft 176, through which the probe 177 has been advanced, so that its distal end including the opening 178 is in contact with the tissue. . Vacuum is applied by vacuum source 340 through lumen 179 to opening 178. Vacuum may have been applied simultaneously into the lumen 108 of the shaft 101.

Now, referring to FIG. 18C, while the tissue manipulation assembly 175 is rearranged, the vacuum is maintained in an applied state through the lumen 179 and the opening 178, so that a force is applied to the contacted tissue accordingly. To induce. The applied force allows the operator to adjust the geometry of the expanded tissue and/or the fluid contained within the expanded tissue. In some embodiments, tissue manipulation is performed during the injection of fluid into the tissue through the needle 141, for example to direct the flow of fluid within the tissue. The applied force may induce the tissue to be “tented” and thus, for example, to be able to adjust the swollen tissue area and/or to create a larger target for penetration by the needle 141. I can.

In some embodiments, a visualization device integral to the endoscope or inserted through the endoscope, such as a visualization element as described above with reference to FIG. 10, is used to adjust the inflated tissue geometry. In some embodiments, fluid is continuously or intermittently injected as various forces are applied to the tissue by the tissue manipulation assembly 175. In some embodiments, a vacuum is applied to the lumen 1080 of the shaft 101 to provide a second tissue manipulation probe.

Although the tissue manipulation assembly 175 of FIGS. 18B and 18C includes a vacuum assisted device, numerous forms and configurations capable of applying force to the tissue may be considered within the spirit and scope of the concepts of the present invention. will be. In some embodiments, the tissue manipulator comprises a balloon; An inflatable ring; Vacuum port; A gripper such as a pair of articulated jaws; A radially expandable cage; A radially deployable arm; And one or more of combinations thereof.

Turning now to FIG. 19, a system for removing or otherwise treating target tissue and for expanding tissue is shown, consistent with the concepts of the present invention. System 300 is configured and arranged to treat target tissue 10, including one or more tissue portions. System 300 is described in International PCT Application No. PCT/US2012/01739, filed Jan. 18, 2012 and entitled “Devices and Methods for the Treatment of Tissue”; And one or more removal devices or removal elements as disclosed in International PCT Application No. PCT US2013/28082 filed on February 27, 2013 and entitled "Heat Ablation Systems, Devices and Methods for the Treatment of Tissue". The contents of each of the above applications are incorporated herein by reference in their entirety. In the embodiment of FIG. 19, system 300 includes a plurality of filament elongated devices 301 including shafts 311a and 311b. In some embodiments, the device 301 is configured to allow treatment of gastrointestinal tissue including the duodenum, jejunum, and/or ileum, with a diameter of less than 6 mm and a length of 100 cm or more, e.g., up to 300 cm. And a flexible portion having a length. The shaft 311 has a distal end 312. The sizes of the shafts 311a and 311b are determined and configured so that the shaft 311a is received in a sliding manner by the shaft 311b. The shafts 311a and 311b have been inserted through a working channel (eg, 6 mm working channel) of the endoscope 350, that is, a lumen 351. Shafts 311a and 311b may be inserted across a guide wire, such as the illustrated guide wire 317 exiting the distal end 312.

Device 301 includes a fluid delivery assembly 130, which may include an inflatable or other fluid delivery assembly that includes one or more fluid delivery elements, as described above. The fluid delivery assembly 130 includes at least one fluid delivery element, i.e., a needle 141, configured and arranged to deliver a fluid to inflate one or more layers of tissue. Alternatively or additionally, the fluid delivery assembly 130 may include additional or alternative fluid delivery elements, such as water injectors or other fluid delivery elements described above. In some embodiments, as described above, for example with reference to FIG. 4B, the needle 141 is configured and arranged to deliver fluid to the tissue by exiting the opening 131 and penetrating into the tissue. In other embodiments, a vacuum may be applied to the opening 131, and accordingly, as described above with reference to FIGS. 5 and 10, for example, by pulling the tissue into the opening 131 so that the needle 141 is It can be allowed to penetrate into the tissue without exiting the opening 131. System 300 may include a source of vacuum, such as a vacuum source 340 that can be fluidly attached to an opening or recess of the fluid transfer assembly 130, for example, the vacuum is a vacuum. It is applied to the opening 131 by the supply source 340.

The fluid delivery assembly 130 may include one or more support arms, such as the various support arms included in the tissue expansion device of FIGS. 4, 5 and 13 described above. The fluid delivery assembly 130 may include an elastically deflected cage or other assembly deflected in a radially expanded condition by a radially compressible to be inserted through the lumen of the endoscope, for example. Alternatively, the fluid delivery assembly 130 may be expanded from a radially compressed state to a radially expanded state. The fluid delivery assembly 130 may include an inflatable balloon, such as a balloon, used to place one or more fluid delivery elements near the tissue to be inflated.

The device 301 further comprises an inflatable tissue treatment element, ie an inflatable treatment element 322b mounted to the shaft 311b. Treatment element 322b is for treating a target tissue, such as one or more treatment element forms, such as a balloon configured to receive a hot or cold fluid, an array of electrodes configured to deliver RF energy, or other treatment modalities. It could be configured in many different forms. In one embodiment, element 322b comprises an inflatable balloon, eg, a compliant balloon; Non-conforming richness; A balloon having a pressure threshold; A balloon having compliant and non-compliant portions; A balloon having a fluid inlet port; A balloon having a fluid outlet port; And one or more of combinations thereof. In another embodiment, the treatment element 322b includes an e-transfer element configured to remove tissue; And one or more of an energy transfer element, such as an energy transfer element configured to deliver RF energy. Shafts 311a and 311b may include one or more lumens passing through, and may include wires or optical fibers for transfer of data and/or energy. One or more concentric shafts configured to deliver and/or recirculate hot fluid through treatment transfer element 322b, for example to transfer a bolus of hot fluid energy or other thermal dose. The same, one or more shafts may be included in the shaft 311b. Device 301 may include a plurality of treatment elements, such as two or more treatment elements configured to deliver similar and/or different forms of energy or other treatments. In an alternative embodiment, the fluid delivery assembly 130 is not inflatable and simply includes a fluid delivery element capable of delivering a fluid to inflate one or more layers of tissue.

The endoscope 350 may be a standard endoscope, such as a standard gastrointestinal endoscope, or a custom endoscope, such as an endoscope including a sensor 353 configured to provide information related to tissue treatment of the concepts of the present invention. Sensor 353 and other sensors of system 300 may include thermal sensors such as thermocouples; Impedance sensors such as tissue impedance sensors; Pressure sensors; Blood sensors; Optical sensors such as optical sensors; Acoustic sensors such as ultrasonic sensors; Electromagnetic sensors such as electromagnetic field sensors; And a sensor selected from the group consisting of combinations thereof. To provide information to one or more components of the system 300, for example to monitor treatment of the target tissue 10 and/or to treat the target tissue 10 in a closed loop manner, the sensor 353 It will be able to be configured. Energy transfer may be modified by one or more sensor readings. In one embodiment, the algorithm processes one or more sensor signals to change the amount of energy delivered, the power of the delivered energy, and/or the temperature of the energy delivery.

A sensor, such as a chemical detection sensor, may be included, for example, to verify proper attachment of the treatment element 322b, fluid delivery assembly 130, and/or needle 141. In such a configuration, a chemical sensor, such as a carbon dioxide sensor, may be disposed distal to the treatment element 322b and/or the fluid delivery assembly 130, and a fluid such as carbon dioxide gas may be applied to the treatment element 322b and/or the fluid delivery assembly. It is introduced close to (130). For example, to prevent improper energy transfer to the target tissue and/or to prevent improper tissue swelling, detection of the introduced fluid may include treatment element 322b, fluid delivery assembly 130 and/or needle 141. ) May indicate improper attachment.

The endoscope 350 may be performed by the operator of the system 300 prior to, during or after treatment of the target tissue 10, for example during insertion or removal of the endoscope 350 and/or shafts 311a and 311b. It may include a camera 352 such as visible light, ultrasound, and/or other visualization devices utilized by. Camera 352 may provide direct visualization of internal body spaces and tissue, such as internal organs of the gastrointestinal tract. The endoscope 350 may be coupled with a guide wire or otherwise include a guide wire, for example to allow insertion of the endoscope 350 into a factory.

The system 300 may be configured to perform ventilation of the body lumen. The body lumen may be pressurized, for example by using one or more standard ventilation techniques. Ventilation fluid may be introduced through the lumen 354 of the endoscope 350. Lumen 354 moves proximally and is connected to a venting source of liquid or gas, not shown but typically air, CO _{2, and/or water.} Alternatively or additionally, the venting fluid may be delivered by the device 301, for example through the shafts 311a and 311b or through a port in the treatment element 322a and/or 322b. The ports are not shown, but are also not shown, are fluidly attached to a source of ventilated liquid or gas. Alternatively or additionally, a separate device configured to be inserted through the endoscope 350 or configured to be disposed along the endoscope 350 may have one or more lumens configured to deliver a venting fluid. The system 300 may include one or more occlusion elements or devices, e.g., an inflatable treatment element 322b, a fluid delivery assembly 130, or, although not shown, radially, e.g., to completely or partially occlude the body lumen. And other expandable devices configured to be inflated to, so that the venting pressure may be achieved and/or maintained over time (e.g., reduce or prevent undesirable movement of the venting fluid. ). One or more occlusive elements or devices may be disposed proximal and/or distal to the ventilated lumen segment.

The treatment elements and fluid delivery assemblies of the concepts of the present invention, for example each treatment element 322b and fluid delivery assembly 130 of FIG. 19, may have a fixed diameter or they may be inflated. . The inflatable elements may include inflatable balloons, inflatable cages, radially deployable arms, and the like. The treatment elements may comprise an energy transfer element or an arrangement of elements, for example an arrangement of balloon lobes for transferring thermal energy from a hot fluid. Energy transfer elements may be configured to deliver one or more different forms of energy. Energy may be delivered in constant or varying magnitudes or at different energy levels. The energy may be continuous or pulsed, and may be delivered in a closed-loop manner. The energy transfer may vary from the first tissue location to the second tissue location, for example, when the second treatment location is thinner than the first treatment location, energy is reduced from the first treatment location to the second treatment location. Alternatively or additionally, deflecting the energy transfer element, for example by adjusting the amount of energy transferred, or by moving a portion of the energy transfer element, e.g. as specifically described above. By doing so, the energy delivery may be varied during a single application to a single tissue location.

Treatment element 322b may be configured to cause complete or partial destruction of the target tissue, for example complete or partial destruction of the duodenal mucosa. Treatment element 322b may be configured to remove previously treated and/or untreated tissue. The pressure maintained within the treatment element 322b is, for example, to adjust the depth of the treatment; To adjust the force applied by the mechanical removal device; To adjust the amount of energy applied during thermal energy transfer (eg, by changing tissue contact); And can be set and/or changed to adjust the treatment performed for these combinations.

Treatment element 322b may include one or more sensors 316b. The sensors 316b may be one or more sensors as described above. The sensors 316b may be sensors configured to provide information related to the tissue treatment performed by the treatment element 322b, for example to distinguish between tissue types proximate to the treatment element 322b, e.g., mucous membranes. And a visualization sensor mounted on the treatment element 322b configured to differentiate submucosal tissue. Alternatively or additionally, such as a temperature sensor mounted to the treatment element 322b and configured to monitor the temperature of the tissue proximate the treatment element 322b and/or the treatment element 322b, the sensor 316b It may be a sensor configured to provide information related to tissue treatment performed following 322b.

An energy delivery and fluid transport unit (EDU) 330 may be configured to deliver one or more fluids to and extract from the treatment element 322b, as well as deliver one or more forms of energy to the target tissue. I will be able to. In one embodiment, EDU 330 is configured to deliver one or more supplies of hot fluid, such as hot water or saline, to the balloon treatment element. In such embodiments, EDU 330 typically includes one or more fluid pumps, for example one or more peristaltic, displacement or other fluid pumps; And one or more heat exchangers or other fluid heating elements inside or outside the device 301. EDU 330 may be constructed and arranged to rapidly transfer and/or recover fluid to and/or from treatment element 322b using one or more fluid vehicles. The fluid vehicle may comprise a pump configured to deliver fluid at a flow rate of at least 50 ml/min, and/or a pump or vacuum source configured to remove fluid at a flow rate of at least 50 ml/min. . The pump or vacuum source may be configured to continuously exchange hot fluid and/or to perform a negative pressure priming event to remove fluid from one or more fluid paths of the device 301. EDU 330 and/or device 301 may include one or more valves in fluid delivery and/or fluid return paths in fluid communication with treatment element 322b. The valves may be configured to control the entry of fluid into the area and/or to maintain the pressure of the fluid within the area. The valves may be used for the transition from a heating fluid, such as a fluid at 90° C., held in the treatment element for about 12 seconds, to a cooling fluid, such as a fluid at 4° C. to 10° C., in the treatment element for about 30 to 60 seconds. I will be able to. Typical valves include, but are not limited to, duck-bill valves; Slit valves; Electronically activated valves; Pressure relief valves; And combinations thereof. EDU 330 may be configured to rapidly inflate/detract treatment element 322b. The EDU 330 may purify the flow paths of the device 301 with a gas, such as air, for example to remove or hold the fluid from the device 301 and/or remove gas bubbles from the device 301. It could be configured to remove.

In another embodiment, the EDU 330 is configured to deliver at least radio frequency (RF) energy, and the system 300 includes a ground pad 332 configured to be attached to the patient (e.g., on the patient's back). And, accordingly, RF energy can be delivered in a unipolar delivery mode. Alternatively or additionally, for example, when the treatment element 322b is configured to deliver RF energy and/or the system 300 is not shown but typically comprises one or more electrodes or electrically conductive surfaces. When including the second energy transfer element, the EDU 330 may be configured to deliver energy in a bipolar RF mode.

Alternatively or additionally, EDU 330 may be configured and arranged to deliver fluid to tissue, for example fluid being delivered to one or more fluid delivery elements, such as needle 141, and thus Causes the expansion of one or more tissue layers, such as one or more layers of the submucosal tissue layers of the gastrointestinal tract. Fluid can be delivered simultaneously and/or sequentially to a plurality of fluid delivery elements. The EDU may provide fluid in a controlled manner, for example at a controlled pressure or flow rate, or at a pre-determined volume, for example at a pre-determined volume per injection.

System 300, although not shown, is one or more operations of system 300 to perform one or more functions, such as entering one or more system input parameters and visualizing and/or recording one or more system output parameters. It may include a controller 360, which typically includes a graphical user interface, configured to allow them. Typical system input parameters include, but are not limited to, the temperature of the fluid to be delivered to the treatment element, such as a balloon; The temperature of the cooling fluid to be delivered; The flow rate of the high-temperature fluid to be delivered; The volume of hot fluid to be delivered; The type of energy to be transferred, such as RF energy, thermal energy and/or mechanical energy; The quantity of energy to be transferred, such as the cumulative value of the energy to be transferred or the peak quantity of the energy to be transferred; Types and levels of combinations of energies to be delivered; Duration of energy transfer; Pulse width modulation percentage of the delivered energy; The number of reciprocating movements for the removal device for traversing; Target temperature furnace temperature for the treatment element, such as the maximum temperature; Aeration pressure; Ventilation duration; Fluid flow rate for tissue expansion; Flow volume for tissue expansion; Vacuum duration for trapping into a recess, such as recess 155 of FIG. 10; A vacuum pressure level, such as a vacuum level applied to a recess, such as recess 155 of FIG. 10; And combinations thereof. System input parameters may include information based on conditions such as the patient's anatomy or pre- or peri-procedural parameters, and the pre- or intra-procedural parameters may include mucosal density and /Or thickness; Mucosal "lift" of submucosal tissue after submucosal injection; The longitudinal location of the target tissue in the GI tract; Tissue layer thickness, such as the thickness of the layer before, during, and/or after expansion of the layer by a fluid delivery element such as needle 141; And combinations thereof. Typical system output parameters include, but are not limited to, temperature information such as tissue and/or treatment element temperature information; Pressure information, such as balloon pressure information or vent pressure information; Force information, such as information on the level of force applied to the organization; Patient information, such as patient physiological information recorded by one or more sensors; And combinations thereof.

One or more other components of controller 360 and/or system 300 may include electronic modules, such as electronic modules including processors, memory, software, and the like. Controller 360 typically allows the operator to initiate and modify the treatment of tissue by the components of the various system 300, for example by energy transfer unit 330 and/or vacuum source 340. And to allow to abort. The controller 360 may be configured to adjust the temperature, flow rate and/or pressure of the fluid delivered to one or more fluid delivery elements, such as the inflatable treatment element 322b and/or the needle 141. Controller 360 may be configured to initiate venting and/or to adjust venting pressure. Controller 360 delivers energy (e.g., from EDU 330), for example by modifying one or more tissue treatment parameters based on signals from one or more sensors of system 300 Or to deliver other tissue treatments in a closed-loop manner. Controller 360 may be programmed, for example, to allow an operator to store predetermined system settings for later use. System 300, EDU 330 and/or controller 360 may include one or more measured properties of the fluid being delivered; One or more measured properties of the treatment element; One or more properties of the fluid transfer element; One or more measured properties of the tissue being treated; One or more measured properties of the tissue to be expanded; Based on a parameter selected from the group consisting of combinations thereof, configured and arranged to modify the temperature, flow rate and/or pressure of the fluid delivered to one or more treatment elements and/or one or more fluid delivery elements. I will be able to.

Controller 360 and EDU 330 may be configured to deliver energy in constant, variable, continuous and discontinuous energy transfer profiles. Pulse width modulation and/or time division multiplexing (TDM) may be included to achieve the accuracy of energy transfer, for example to ensure removal of target tissue without damaging non-target tissue.

System 300 may include a mechanism configured to apply motion to treatment element 322b and/or fluid transfer assembly 130, such as motion transfer element 335. The motion transfer element 335 may be configured to rotate the shafts 311a and 311b and/or to translate along the axial direction, and thus the treatment element 322b and/or the fluid transfer assembly 130 ) Each is rotated and/or translated. Motion transfer element 335 may be configured to independently or integrally rotate treatment element 322b and fluid transfer assembly 130. Motion transmission element 335 may include one or more rotational or linear drive assemblies, such as those including rotary motors, magnetic and other linear actuators, etc., that are connectable to shafts 311a and 311b. There will be. Shafts 311a and 311b have sufficient column strength and/or sufficient column strength to sufficiently rotate and/or translate each of treatment element 322b and/or fluid delivery assembly 130 during associated tissue treatment and/or tissue expansion. It consists of torque transmission properties. The motion transfer element 335 is a controller, for example, in order to activate, adjust and/or otherwise control the motion transfer element 335, thus the motion of the treatment element 322b and/or the fluid transfer assembly 130. You will be able to communicate with (360). The motion transmission element 335 may be driven manually and/or automatically (eg, a motor). Alternatively or additionally, the motion transfer element 335 moves the treatment element 322b and/or the fluid transfer assembly 130 from a first position to treat or expand the first portion of the target tissue. It may be used to advance or retract to a second position for treating or expanding the second portion. In such an embodiment, the repositioning of the treatment element 322b and/or the fluid delivery assembly 130 may be configured to provide overlapping treatments and/or tissue expansions.

Controller 360 may be configured to control energy transfer, such as controlling energy transfer to treatment element 322b. For example, if treatment element 322b is an RF electrode arrangement, and EDU 330 includes an RF generator, controller 360 may be programmed to provide a certain amount of RF energy for a defined period of time. I will be able to. In another example, if the treatment element 322b is based on a heated saline balloon, for example, through an energy transfer tube not shown, at the desired temperature and for a desired period of time, the controller 360 may perform the treatment element 322b. ) Can be configured to provide and recover heated saline. Controller 360 may be configured for manual control, thus allowing the operator to initiate energy transfer first and then to allow treatment element 322b to remove tissue for a period of time. , Then the operator will be able to terminate the energy transfer.

System 300 may further include one or more imaging devices, such as imaging device 370. The imaging device 370 may be configured to be inserted into the patient, and when integrated, attached, for example in the shafts 311a and 311b and/or in close proximity to the shafts 311a and 311b, When accommodated, a visible light camera; Ultrasonic imaging device; Optically correlated interferometer (OCDR) imaging device; And/or an optically correlated tomography (OCT) imaging device. The imaging device 370 may be inserted through a separate working channel of the endoscope 350, that is, a lumen, not shown. In one embodiment, the imaging device 370, not shown, is surrounded by a shaft 311a and is typically rotated and/or translated to create a multi-dimensional image of the area around the imaging device 370. It is an ultrasonic transducer connected to the shaft. Alternatively or additionally, the imaging device 370 may include an X-ray; Fluoroscopy; Ultrasound images; MRI; PET scanner; And an imaging device selected from the group consisting of combinations thereof.

The system 300 may further include a protective cap 380, configured to be placed proximate the tissue to prevent damage to a particular tissue during an energy transfer or other tissue treatment event. The protective cap 380 may be delivered with the endoscope 350 or other elongate device, so that the cap 380 may be placed over the Vater's Ampulla and may be placed to protect the Ampulla. In a typical embodiment, the protective cap 380 is removed within 24 hours of placement, for example by being removed during the procedure after treatment of the target tissue.

In addition to or as an alternative to fluid delivery assembly 130, system 300 may include one or more tissue expansion devices 100 of FIG. 1 or other tissue expansion device as described herein with reference to FIGS. And a tissue expansion device 390 configured to expand a target tissue area, such as a submucosal tissue expansion device. The tissue expansion device 390 may be inserted through and/or along the endoscope 350. Tissue expansion greatly reduces the need for precision of the treatment, such as the precision of energy transfer, which increases the size of the target tissue (e.g., increased depth) and the safety of the associated tissue that the treatment does not cause significant negative events This is due to the area (eg, the swollen submucosal tissue layer prior to removal of the mucosal tissue layer).

System 300 may further include one or more medicaments or other agents 500, such as an agent configured for systemic and/or localized delivery to a patient. These agents may be delivered before, during and/or after the procedure. Agents include mucosal cell protective agents such as sucralfate, proton pump inhibitors or other acid blocking drugs, antibiotics and steroids; And agents selected from the group consisting of combinations thereof. Alternatively or in addition to these agents, pre- and/or post-procedure diet regimens may be employed. Pre-procedure diets may include food intakes low in carbohydrates and/or low in calories. Post-procedure diets may include dietary intake including a whole liquid diet or a low calorie and/or low carbohydrate diet. In some embodiments, a diuretic or fluid reducing agent may be delivered to the patient, eg, a diuretic is delivered after completion of the tissue dilation procedure.

In a typical embodiment, the system 300 does not include components or devices that are chronically implanted, but only those implantable devices that are removed shortly after or at the end of the clinical procedure, e.g., within 8 hours of insertion. It includes only devices that are removed within 24 hours of insertion and/or removed within one week of insertion. In an alternative embodiment, an implant 510 may be included. The implant 510 includes a stent; sleeve; And drug delivery devices such as coated stents, coated sleeves, and/or implanted pumps. In embodiments including an implant, such as implant 510, tissue expansion, such as submucosal tissue expansion, may be performed, for example, to improve the fixation of the implant to the lumen wall of the gastrointestinal tract.

Each of the components of the system 300 includes other components, in particular a controller 360, an energy transfer unit 330, a vacuum source 340, a motion transfer element 335, a ground pad 332, and an endoscope 350. ) And device 301.

Although the preferred embodiments of devices and methods have been described with reference to the environment in which the embodiments were developed, such embodiments are only intended to illustrate the principles of the inventions. Variations or combinations of the above-described assemblies, other embodiments, configurations and methods for carrying out the invention, and variations of aspects of the invention that are apparent to those skilled in the art will be included within the scope of the claims. Also, if the present application has a method or process, in a specific order, with the steps listed, it may be possible to change the order in which some steps are performed, or even be convenient in certain situations, and the specificity of such order. Unless expressly stated in this claim, the particular steps of a method or process claim set forth below should not be regarded as order-specific.

Claims (28)

As a device for expanding tissue:
Elongated shaft;
At least one fluid transfer tube comprising a proximal end, a distal end and a lumen therebetween, the elongate shaft having a distal end surrounding the at least one fluid transfer tube;
At least two or more hollow fluid transfer needles in fluid communication with the lumen of the at least one fluid transfer tube; And
An inflatable support comprising a recess configured and arranged to receive the hollow fluid transfer needle in a sliding manner,
The at least two or more hollow fluid transfer needles are configured and arranged to deliver fluid to the lumen wall tissue,
Wherein the device is configured and arranged to effect a global circumferential expansion of the lumen wall tissue. The method of claim 1,
Wherein the overall circumferential expansion is effected in a single operator fluid delivery step. The method of claim 2,
Wherein the single operator fluid delivery step comprises simultaneous or sequential fluid delivery from the at least two or more hollow fluid delivery needles. The method according to any one of claims 1 to 3,
The device comprises: narrowing a lumen surrounded by lumen wall tissue; Delivering a pre-determined volume of fluid into tissue; Or a tissue expansion device configured and arranged to effect at least one of providing pressure-controlled delivery of fluid into tissue. The method according to any one of claims 1 to 3,
Wherein the lumen wall tissue comprises submucosal tissue. The method according to any one of claims 1 to 3,
Wherein the at least two or more hollow fluid transfer needles are configured to deliver fluid simultaneously or sequentially. The method according to any one of claims 1 to 3,
Wherein the at least two or more hollow fluid transfer needles comprise at least three hollow fluid transfer needles disposed in a relatively circumferential arrangement. The method according to any one of claims 1 to 3,
Wherein the at least two or more hollow fluid transfer needles comprise at least three hollow fluid transfer needles and the at least one fluid transfer tube comprises a single fluid transfer tube. The method of claim 8,
A manifold configured and arranged to connect the single fluid transfer tube to a first hollow fluid transfer needle, a second hollow fluid transfer needle, and a third hollow fluid transfer needle. device. The method according to any one of claims 1 to 3,
The tissue inflation device further comprising at least one outlet port, wherein the at least two or more hollow fluid transfer needles are configured and arranged to be advancing out of the at least one outlet port. The method according to any one of claims 1 to 3,
Wherein the at least two or more hollow fluid transfer needles comprise an advancing fluid transfer element. The method of claim 11,
And a surface disposed to limit advancement of the at least two or more hollow fluid transfer needles. The method of claim 11,
Wherein the at least two or more hollow fluid transfer needles are constructed and arranged to advance a fixed distance. The method of claim 11,
Wherein the at least two or more hollow fluid transfer needles are configured and arranged to advance into the recess. The method according to any one of claims 1 to 3,
And a spring-loaded fluid transfer element advancing assembly. The method of claim 15,
Wherein the spring-loaded fluid transfer element advancing assembly is constructed and arranged to advance the at least two or more hollow fluid transfer needles. The method according to any one of claims 1 to 3,
Wherein the at least two or more hollow fluid transfer needles are configured and arranged to move laterally as the lumen wall tissue expands. The method according to any one of claims 1 to 3,
Wherein the at least two or more hollow fluid transfer needles are constructed and arranged to be retained within the recess. The method according to any one of claims 1 to 3,
And a fluid configured and arranged to be delivered to the lumen wall tissue through the at least two or more hollow fluid transfer needles. The method of claim 19,
The fluid, a vascular sclerotic agent; Anti-inflammatory; Antimicrotubule inhibitors or other mitosis inhibitors; Alkylating agents; Antimetabolite; Anthracycline; Plant alkaloids; Topoisomerase inhibitors; Anti-proliferative substances; And a fluid constructed and arranged to provide a bioactive function selected from the group consisting of combinations thereof. The method according to any one of claims 1 to 3,
And further comprising a manipulation assembly. The method of claim 21,
The manipulation assembly includes manipulating one or more of tissue, fluid, or delivered fluid; Wherein the at least two or more hollow fluid transfer needles are configured and arranged to effect at least one of preventing movement of that portion of tissue as it penetrates into the portion of tissue. The method according to any one of claims 1 to 3,
And a pressure monitoring assembly configured and arranged to monitor pressure at at least one of before, during, and after expansion of the tissue. delete The method according to any one of claims 1 to 3,
Wherein the device has an operable insertion length of at least 100 cm. delete delete delete

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