CN102470041B - An ostomy appliance with a leakage indicator - Google Patents

An ostomy appliance with a leakage indicator Download PDF

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Publication number
CN102470041B
CN102470041B CN201080030148.XA CN201080030148A CN102470041B CN 102470041 B CN102470041 B CN 102470041B CN 201080030148 A CN201080030148 A CN 201080030148A CN 102470041 B CN102470041 B CN 102470041B
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CN
China
Prior art keywords
ostomy appliance
thin slice
surveyed area
moisture
appliance according
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Active
Application number
CN201080030148.XA
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Chinese (zh)
Other versions
CN102470041A (en
Inventor
H·爱德华森
M·汉森
D·乔克
L·F·尼尔森
K·H·尼尔森
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Coloplast AS
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Coloplast AS
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Publication of CN102470041A publication Critical patent/CN102470041A/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F5/443Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices having adhesive seals for securing to the body, e.g. of hydrocolloid type seals, e.g. gels, starches, karaya gums
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F5/4404Details or parts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00727Plasters means for wound humidity control
    • A61F2013/00731Plasters means for wound humidity control with absorbing pads

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

An ostomy device that comprises an adhesive wafer (1) for attaching to the skin around the stoma. The wafer comprises an adhesive layer (3) having a proximal adhesive surface and a distal surface. The distal surface is covered with a backing layer (2). The wafer comprises a central portion (6) and a peripheral portion (7), and it comprises at least a first and a detection zone (4), wherein the detection zone is configured to provide a tactile sensation on the distal surface of the wafer when exposed to moisture.

Description

A kind of ostomy appliance with leakage indicator
Background of invention
1. invention field
The present invention relates to a kind of ostomy appliance with leakage indicator.
For collecting the health auxiliary equipment of body fluid, usually there is leakage problem.The root of leaking can have many, for example the time of wearing of inferior properties of product, prolongation, for wrong choice or incorrect application and the use of the product of task.Leakage has caused clothes pollution, psychological uncomfortable and inconvenient, but also has the more serious problem as infection and skin disorder.
It is available being intended to for collecting many products and the adnexa of body fluid, and selects can reduce in many cases for the correct combination of individual solution the probability of leakage.
Device with electronics Leak Detection makes various advanced persons and complicated solution become possibility, yet with regard to the complexity of production cost, user interface, regulate complexity and be incorporated into regard to the environmental problem relevant with processing electronic component in disposable collecting device, they are not best solution.
2. description of Related Art
Detect to leak or indicate for changing the distinct methods of the time of gathering-device and seen existing solution.
The U.S. 5,942,186 have disclosed a kind of adhesive boards with indicator feature, and a kind of indicator used for this reason.This indicator is a kind of hydrophilic compositions, said composition contains a kind of water solublity colorant, as a kind of food coloring, a kind of dyestuff, a kind of pigment or slaine, these materials are applied to a part or on the whole or be embedded in wherein for the outer regions (away from its center) of this plate.This water solublity colorant is soluble in liquid discharges or exudate.Visible indication when its changes color and provides working life of this adhesive boards to finish.
Europe 1,991,187 has disclosed a kind of method of the disengaging for detection of dressing (being applied to a surface of the object of at least part of conduction).This dressing comprises a kind of for this dressing being attached to the binding agent on this conductive body and being arranged at least two electrodes that are spaced a distance with this conductive body.A voltage is applied on this first and second electrode, thereby set up a circuit, this circuit is included in first capacitor and second capacitor between this second electrode and this conductive body between this first electrode and this conductive body.Detection this first and the capacitance variations one of at least and between this conductive body of this second electrode, and when the variation of this electric capacity reaches a predetermined value, activate an alarm.
Yet so exist needs for indicating a kind of equipment of the leakage of ostomy appliance to appoint in a kind of simple and discontinuous mode.
Brief Description Of Drawings
Disclosed in greater detail with reference to the attached drawings the present invention, wherein
Fig. 1 has shown a top view of a preferred embodiment of the present invention, and
Fig. 2 has shown the cross section of this embodiment.
Detailed description of the invention
The present invention relates to a kind of ostomy appliance, this ostomy appliance comprises for attachment to a kind of adhesive sheet on stoma (stoma) skin around, this thin slice comprises an adhesive phase with a near-end adhesive surface and a distal surface, this distal surface covers with a backing layer, this thin slice comprises a core and an outer peripheral portion, this thin slice comprises at least one surveyed area, and wherein this surveyed area is configured on the distal surface of this thin slice, provide a sense of touch when being exposed to moisture.
For " near-end ", at this, represent to approach most the part of skin, for " far-end " presentation surface to the part of leaving skin.
By there is a region on this thin slice, to being exposed to moisture, make a response, produce thus a realizable variation, present sense of touch leakage indicator.This tactile indicators is discontinuous for user, because it can be felt by clothes and/or collecting bag, and this user can be controlled leak condition and without exposing this device.
Device of the present invention provides a kind of simple and effectively leakage indication.This device can detect and indicate the leakage below the binding agent that occurs in this thin slice.Because when application this bag time this bag usually cover this adhesive sheet, there is indicator and make us wishing, it is not only this expression observable and otherwise monitors leakage.Electronic alarm is known in the art, but is complicated and expensive for the use in disposable.The tactile indicators of device of the present invention can be easily by the finger of user or hands is felt and therefore can be checked discontinuously.This tactile indicators is the form that is at least one surveyed area in this adhesive sheet, when being exposed to moisture this indicator by reacting in the variation aspect thickness and/or flexibility, thereby on the distal surface of this thin slice, provide a kind of sense of touch.
If this surveyed area changes aspect thickness due to moisture absorption, the pattern of the distal surface of this thin slice changes, and then when this user contacts this surface, can feel this variation.
In one embodiment, when being exposed to moisture, the flexibility of this surveyed area changes.When flexibility changes, the pattern of the distal surface of this thin slice not must change.But the perception on the distal surface of this surveyed area (by being felt with contacting of finger) can be changed, for example the gel texture from a kind of hard texture to a kind of softness.For hard expression, being incompressible substantially, is compressible or gelatinous for the expression of softness.
The solution of this tactile indicators does not require the use of electronic equipment, and therefore these rules and the challenge relevant with such solution is not a problem.In addition, reduced the problem about the environment aspect of the processing of this device.
Device of the present invention provides a kind of security of increase and will reduce and leak relevant risk for this user.When be exposed to from leak moisture time, the texture of this surveyed area occurred to change and on the distal surface of this thin slice for example the form with projection and/or softening round dot a kind of sense of touch is provided, these round dots can easily be felt by touch.The simple and easy inspection of the leakage in therefore can making progress discontinuously, without disrobing or exposing this bag/device.
For sense of touch, represent a kind of variation that can be felt by touching (typically by finger or hands).This variation can be the form of the variation of the surperficial pattern aspect in this thin slice, and as projection, recessed knob or ridge, or it lacks, or for the variation of the flexibility aspect of this surveyed area.
This tactile indicators is made a response to the leakage from stoma and to excessive perspiration, causes that the surveyed area of this adhesive sheet absorbs moisture.This sense of touch that has produced the distal surface of this thin slice changes, and this indicates this user should change it.
In this embodiment, when being exposed to leakage, the thickness of this surveyed area may increase.
This surveyed area can comprise a kind of component that changes texture when being exposed to moisture.The example of such component is hydrocolloid, high water-absorption fiber, high water-absorption particle, alginic acid salt, polysaccharide, foam or their mixture.This component can be for example by swelling, subside, dissolve or harden and moisture is exposed and reacted.This reaction can be due to the physical form of this component and/or because its chemical property causes.
Binding agent for neostomy thin slice can contain hydrocolloid or other moisture absorption components.This surveyed area can comprise one or more moisture-sensitive type components, this or these components are in a kind of like this form, than the binding agent of this thin slice, for moisture, produce soon a kind of and more obviously reaction, thereby at this binding agent, be subject to monitoring this leakage before its impact.
In one embodiment, when being exposed to leakage, the thickness of this surveyed area reduces.When being exposed to moisture by contributing to this in conjunction with a kind of component of subsiding or dissolving.
When being exposed to moisture, the variation of this second area thickness should be realizable, be at least less than or greater than this second area when dry thickness 10%, 20%, 30%, 40%, 50%, 60%, 75% or 100%.
This surveyed area can be thinner than the outer peripheral portion of this adhesive sheet.When being exposed to moisture, it may be expanded to and is greater than this thickness of the thickness of thin slice around, thus the reaction that has produced a kind of easy sensation.
In one embodiment, this surveyed area be than this adhesive sheet thickness around thicker or substantially identical with it.
For phrase " core ", be illustrated in a region of the core of this thin slice.Center should be interpreted as in the mid portion of this thin slice rather than periphery, but should not be to be symmetrically located on this thin slice.Phrase " outer peripheral portion " is appreciated that the part around this core.By a collecting bag, be attached (maybe can adhere to) to the part on it by this core and this outer peripheral portion separately.In use, the core of this thin slice will be in the inside of this collecting bag, and this outer peripheral portion will be in the outside of this bag.
Can there are a plurality of surveyed areas and they can be arranged with a pattern.
This or these surveyed area can have different configurations and can be the form in one or more cohesion regions or a plurality of discontinuous regions.For example they can be the forms in one or more concentric circuit orbits, or it can be in randomly or the round dot of arranging with a pattern or the form of knob or line.These points or line can be alignd on a circuit orbit, with the center of this thin slice be concentric.These points or line can be projection or protrude.
When these surveyed areas are arranged with a pattern, it is easy detecting leakage point and progress thereof.Pattern array that example can be discontinuous round dot like this, thus promote this or these round dot being exposed to from the moisture leaking to be affected, and other round dot will can not be affected.By this way, accurately feel that what degree the point of the leakage on this thin slice and it have proceeded to is easy, and determine when thus it is the time of changing this device.These surveyed areas can be for example positioned in the position of this core or in the position of this outer peripheral portion or in both position by the round dot array in each part.
The moisture-sensitive type component of this surveyed area can be arranged to and be embedded at least in part in this adhesive sheet.In one embodiment, the component of this surveyed area can be extended the whole thickness that spreads all over this thin slice.
In order to make the sense of touch of this surveyed area more obvious, in this surveyed area, the backing layer of this thin slice can protrude.An example of this protrusion can be in order to produce depression in the distal surface of this thin slice.When the component in this region is exposed to moisture, its meeting swelling and expansion is then rotated this protrusion to produce a kind of obvious projecting point or ridge at this distal surface place " from inside to outside ".
The backing layer of this thin slice can be any applicable layer, as a kind of thin polymer film, nonwoven foam or a kind of foamed thin sheet.This backing layer can be steam and water impervious, but or it can be that water impervious steam is permeable.
This or these surveyed area can be equipped with a backing layer more pliable and tougher than the backing layer of this thin slice.This more soft and more pliable and tougher backing layer can promote the more obvious expansion of these surveyed areas.
In addition, the sense of touch of these surveyed areas can maintain or even just realize by changing the texture of the backing layer on this or these surveyed area.For example this backing layer can be equipped with a rugged surface.If this surveyed area is thinner than thin slice around before being exposed to moisture, this rugged surface can not be felt so, but when this surveyed area expands, this rugged surface will become accessible and for finger, be therefore realizable.
This ostomy appliance can further be equipped with a visual detector, and when being exposed to moisture, this indicator produces a kind of variation aspect color.This visual detector can be incorporated in this surveyed area or its part, or it can be incorporated in this adhesive sheet partially or completely.For ease of visual, approach, this visual detector can be positioned on the outer peripheral portion of this thin slice.
This visual detector can be made a response to the existence of moisture, or it can be more specific and for example only to reacting from stoma's Excreta and for example moisture from perspiration not being reacted.By using pH specificity indicator or can realizing this difference to some enzyme or the special indicator of cell component.
In one embodiment, when being exposed to moisture, this indicator produces a kind of variation and this variation can be felt by this user aspect temperature.
The health of a common ostomy appliance adheres to sheet segment and is collected bag and hides.For a user, this makes the vision leakage indicator of monitoring on this thin slice is difficult.In addition, the optimum position of a test point will be in distance the position from 1mm to 25mm towards the edge of this stoma's core, and this by typically in the slice part office of the inside of this bag, and be therefore difficult to visual approaching.
This visual detector can be equipped with a wicking system, wherein at one or more test points place of the central part office of this thin slice, moisture is collected, and then be transported in the color indicator of the peripheral part office of this thin slice by a wick, thereby produced a kind of visible response here.Like this, a commitment in this leakage has detected moisture and has made it visual.This wick material can be made by many kinds of absorbent materials, as adhesive-bonded fabric, filter paper, textile, binding agent or superabsorbers (as acrylic acid and analog).
The adhesive phase of this thin slice can be any applicable binding agent to skin-friendly.
This ostomy appliance can be a kind of single type device, one of them collecting bag is attached on this thin slice inseparably, or it can be a kind of two-piece devices, wherein this thin slice and this collecting bag are equipped with combination tool and can therefore adhere to mutually with separated.
Embodiment is described
Referring now to the accompanying drawing that these embodiments are shown, illustrate in greater detail the present invention.
Fig. 1 has shown a view of the distal surface of a preferred embodiment of the present invention.Fig. 2 has shown the cross section of this same embodiment.This device comprises a thin slice (1), and this thin slice comprises that a backing layer (2) and an adhesive phase (3) and one are for adapting to this stoma's centre bore (10).This thin slice (1) comprises at least one surveyed area (4), and this surveyed area (4) is the form in projection, and these projections have a ratio less thickness of adhesive sheet around.This part (5) that is used for adhering to a collecting bag (for the sake of clarity, not showing this bag in these figure) by this core (6) and this outer peripheral portion (7) separately.When be exposed to from leak moisture time, these females of this surveyed area (4) will expand, and these regions (4) will swell at least identical with this adhesive sheet around thickness and can swell to a thickness that is greater than the thickness of this thin slice, thereby on the distal surface of this thin slice (1), provide the round dot of a plurality of protuberances.Only this leakage region has been subject to impact, therefore user is felt to degree and its position of leaking are easy.Fig. 2 has shown a kind of restricted leakage, and some of them surveyed area round dot is become outstanding knob (8) by protuberance.Those surveyed area round dots (4) that are not exposed to this leakage do not swell.

Claims (10)

1. an ostomy appliance, this ostomy appliance comprises for attachment to an adhesive sheet on stoma's skin around;
-this thin slice comprises an adhesive phase, and this adhesive phase has a near-end adhesive surface and a distal surface;
-this distal surface covers with a backing layer;
-this thin slice comprises a core and an outer peripheral portion;
-this thin slice comprises at least one surveyed area;
-wherein this surveyed area is configured on the distal surface of this thin slice, provide a sense of touch when being exposed to moisture, and described sense of touch reduces to provide by the thickness of surveyed area described in when absorbing moisture.
2. ostomy appliance according to claim 1, wherein when being exposed to moisture, the thickness of this surveyed area can reduce at least 10%.
3. ostomy appliance according to claim 1, wherein this backing layer on this surveyed area protrudes.
4., wherein there are a plurality of surveyed areas in ostomy appliance according to claim 1.
5. ostomy appliance according to claim 1, wherein this surveyed area is formed a circuit orbit.
6. ostomy appliance according to claim 1, wherein this surveyed area is formed a kind of discontinuous round dot.
7. ostomy appliance according to claim 4, wherein these surveyed areas are aligned on a circuit orbit.
8. ostomy appliance according to claim 1, wherein said ostomy appliance also comprises another region, described another region comprise a kind of when absorbing moisture in the component that can change aspect flexibility.
9. ostomy appliance according to claim 1, wherein this surveyed area is positioned on the outer peripheral portion of this thin slice.
10. ostomy appliance according to claim 1, wherein this thin slice is equipped with a kind of visual detector, and when this surveyed area is exposed to moisture, this visual detector can change color.
CN201080030148.XA 2009-07-07 2010-06-22 An ostomy appliance with a leakage indicator Active CN102470041B (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
DKPA200970055 2009-07-07
DKPA200970056 2009-07-07
DKPA200970056 2009-07-07
DKPA200970055 2009-07-07
PCT/DK2010/050152 WO2011003420A1 (en) 2009-07-07 2010-06-22 An ostomy appliance with a leakage indicator

Publications (2)

Publication Number Publication Date
CN102470041A CN102470041A (en) 2012-05-23
CN102470041B true CN102470041B (en) 2014-10-08

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CN201080030148.XA Active CN102470041B (en) 2009-07-07 2010-06-22 An ostomy appliance with a leakage indicator

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US (1) US9066812B2 (en)
EP (1) EP2451413B1 (en)
CN (1) CN102470041B (en)
BR (1) BR112012000377B1 (en)
RU (1) RU2527352C2 (en)
WO (1) WO2011003420A1 (en)

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US20120143154A1 (en) 2012-06-07
RU2527352C2 (en) 2014-08-27
EP2451413B1 (en) 2013-08-14
EP2451413A1 (en) 2012-05-16
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BR112012000377A2 (en) 2016-03-29
US9066812B2 (en) 2015-06-30

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