WO2020219153A1

WO2020219153A1 - Pressure relief panel for ostomy pouch

Info

Publication number: WO2020219153A1
Application number: PCT/US2020/019205
Authority: WO
Inventors: George J. CISKO
Original assignee: Hollister Incorporated
Priority date: 2019-04-26
Filing date: 2020-02-21
Publication date: 2020-10-29

Abstract

An ostomy pouch includes a pouch wall defining a collection chamber and having a first portion and a second portion, and an inlet opening configured to receive a discharge for collection in the collection chamber. The first portion is a pressure relief panel formed from an elastomeric material and configured to elastically deform in response to a predetermined pressure in the collection chamber.

Description

TITLE

PRESSURE RELIEF PANEL FOR OSTOMY POUCH

BACKGROUND

[0001] The following description relates to an ostomy appliance, for example, an ostomy pouch having an elastically deformable pressure relief panel.

[0002] An ostomy pouch is generally formed by a wall structure defining an internal volume. For example, a known ostomy pouch construction includes a first sidewall and a second sidewall sealed to one another along their respective peripheries to define the internal volume therebetween. The sealed peripheries form a periphery of the ostomy pouch. One sidewall includes an inlet opening through which bodily waste may be received from a stoma. The bodily waste may then be collected and stored in the internal volume. A barrier element may be disposed about the inlet opening for securing the ostomy pouch to a wearer. The barrier element may be, for example, a barrier seal configured to adhere and seal between the wall structure and the skin of the wearer.

[0003] During use, ostomy pouches may be subjected to periodic spikes in internal pressure, i.e., a pressure in the internal volume, due to pouch ballooning and/or inadvertent compression of a partially-filled ostomy pouch. Such pressure spikes may occur, for example, in response to various motions of the wearer. For instance, when a wearer bends to tie their shoes, leans in a particular direction, rolls onto the pouch while sleeping, or is seated in certain positions, a force may be applied to an outer portion of the ostomy pouch reducing the internal volume, and in turn, causes a pressure increase within the internal volume. The pressure spike leads to increased stresses within the ostomy pouch, for example, along the wall structure. If the stresses are high enough, film herniation, seal failure and/or barrier or skin separation may occur.

[0004] Some known ostomy pouches are expandable to accommodate collection of a larger volume of bodily waste in the collection chamber. For example, an ostomy pouch of the type described in WO 2015/011182 includes a waste collection space defined by two opposing surfaces of two walls. The opposing surfaces are configured to separate on the introduction of waste through an inlet and in at least one of the walls there is at least one corrugation. The corrugation is deformable under the weight of waste in the pouch. Thus, the pouch may expand by deformation of the corrugation as a weight of the waste in the pouch increases.

[0005] Another ostomy pouch, of the type described in WO 2016/004959 for example, includes a cap portion and an expandable portion. The expandable portion is folded inside the cap portion with the outer surfaces facing each other. The cap portion is folded over and envelopes the expandable portion with inner surfaces facing each other. Thereby, the expandable portion will have a tendency to be folded up inside the cap portion. The ostomy pouch can be moved to an expanded configuration by unfolding the expandable portion.

[0006] However, the known expandable ostomy pouches described above are configured for expansion to accommodate collection and storage of larger volumes of bodily waste within the ostomy pouch. Such expansion is permanent and results in an enlarged, bulky, heavy and/or uncomfortable expanded ostomy pouch. Moreover, the known expandable ostomy pouches may not reliably expand when subjected to internal pressure spikes and thus, may experience the same drawbacks as non-expandable ostomy pouches during a pressure spike.

[0007] Accordingly, it is desirable to provide an ostomy pouch which may temporarily expand in response to pressure spikes and return to an unexpanded size and shape when the pressure spike has subsided.

SUMMARY

[0008] An ostomy pouch includes a pouch wall defining a collection chamber therein and having a first portion and a second portion, and an inlet opening configured to receive a discharge for collection in the collection chamber. The first portion is a pressure relief panel formed from an elastomeric material and is configured to elastically deform in response to a predetermined pressure in the collection chamber.

[0009] The pouch wall may include a first wall and a second wall joined to one another along their respective peripheries to form a sealed periphery. The first wall may be a body-facing side and the second wall may be an outer-facing side of the ostomy pouch. The pressure relief panel may be formed in the second wall.

[0010] The second portion of the pouch wall may be a film. The film may include a thermoplastic polymer material. The film may be a multilayer film. [0011] The second portion may not overlap or coextend with the first portion. The first portion may have a lower modulus of elasticity than the second portion. The first portion may be formed only from the elastomeric material.

[0012] The ostomy pouch may further include a drainage outlet configured for draining the discharge from the collection chamber.

[0013] The first portion may be rectangular, circular, or oblong in shape.

[0014] The first portion may extend from one lateral side of the pouch wall to another lateral side of the pouch wall. Alternatively, or additionally, the first portion may extend along an upper portion of the pouch wall. Alternatively, or additionally, the first portion may be formed at a lower portion of the pouch wall.

[0015] The pouch wall may include a plurality of first portions.

[0016] The first portion may be in a first condition when a pressure in the collection chamber is below the predetermined pressure and may be in an elastically deformed second condition when pressure in the collection chamber exceeds the predetermined pressure.

[0017] Other objects, features, and advantages of the disclosure will be apparent from the following description, taken in conjunction with the accompanying sheets of drawings, wherein like numerals refer to like parts, elements, components, steps, and processes.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG. l is a cross-sectional side view of an ostomy pouch having a pressure relief panel according to an embodiment;

[0019] FIG. 2 is a perspective view of an ostomy pouch having a pressure relief panel according to another embodiment;

[0020] FIG. 3 is a perspective view of an ostomy pouch having a pressure relief panel according to another embodiment;

[0021] FIG. 4 is a perspective view of an ostomy pouch having a pressure relief panel according to another embodiment;

[0022] FIG. 5 is a perspective view of an ostomy pouch having a pressure relief panel according to another embodiment;

[0023] FIG. 6 is a perspective view of an ostomy pouch having a pressure relief panel according to another embodiment; and [0024] FIG. 7 is a perspective view of an ostomy pouch having a pressure relief panel according to another embodiment.

DETAILED DESCRIPTION

[0025] While the present disclosure is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described one or more

embodiments with the understanding that the present disclosure is to be considered illustrative only and is not intended to limit the disclosure to any specific embodiment described or illustrated.

[0026] FIG. 1 is a cross-sectional side view of an ostomy pouch 100 according an embodiment. The ostomy pouch 100 may generally include a pouch wall 110 defining a collection chamber 112 therein. In one embodiment, the pouch wall 110 may be formed by a first wall 114 and a second wall 116 joined to one another along their respective peripheries to form a sealed periphery 118 of the ostomy pouch 100. The collection chamber 112 may be formed between the first wall 114 and the second wall 116. In one embodiment, the first wall 114 may be a proximal or body -facing side of the ostomy pouch 100 and the second wall 116 may be a distal or outer-facing side of the ostomy pouch 100. The first wall 114 and the second wall 116 may be joined by, for example, heat sealing, welding, one or more adhesives or other known, suitable fastening or joining techniques to form a sealed joint.

[0027] The ostomy pouch 100 further includes an inlet opening 120 formed in the pouch wall 110, for example, in the first wall 114. The inlet opening 120 is configured to receive a stoma, or be positioned adjacent to a stoma, to receive a discharge (bodily waste) 122 from the stoma. The discharge 122 may be collected and stored in the collection chamber 112. An ostomy barrier 124 may be disposed about the inlet opening 120.

[0028] The pouch wall 110 includes a first portion 126 and a second portion 128.

In one embodiment, the first portion 126 is a pressure relief panel 126 configured to elastically deform in response to a pressure increase in the collection chamber 112. To this end, the pressure relief panel 126 may be formed from an elastomeric material.

[0029] The second portion 128 may be, for example, a film 128 suitable for use in ostomy pouch applications, such as a known multilayer film. An example of such a film is described in U.S. Pat. No. 9,301,869, commonly assigned with present application and incorporated herein by reference. The film 128 may include, for example, a barrier layer, one or more tie layers, one or more inner layers, and/or one or more outer layers. One or more of the layers may be formed from a suitable polymeric material, such as a thermoplastic polymer, copolymer, and the like. Other suitable multilayer films are envisioned as well, having fewer, more and/or differently constructed layers.

[0030] In one embodiment, the pressure relief panel 126 may be formed in the second, distal wall 116 so that deformation, or expansion, of the elastomeric material in response to a pressure increase may be substantially unaffected by, and free of interference from, a portion of the wearer’s body adjacent to the proximal, first wall 114 at the body -facing side of the ostomy pouch 100. In one embodiment, the pouch wall 110 may include only one pressure relief panel 126. In another embodiment, however, the pouch wall 110 may include a plurality of pressure relief panels 126. In one embodiment, the pressure relief panel 126 has an area that is less an area of the wall (i.e., the first wall 114 or the second wall 116) of which is forms a part.

[0031] In one embodiment, the second portion 128 does not overlap or coextend with the first portion 126. In one embodiment, the second portion 128 is more resistant to deformation than the first portion 126. That is, the first portion 126 has a lower elastic modulus than the second portion 128. Accordingly, the first portion 126 may elastically deform at a lower internal pressure than the second portion 128.

[0032] In one embodiment, a thickness of the pouch wall 110 at the first portion, i.e., the pressure relief panel 126, is formed entirely by the thickness of the elastomeric material. That is, in one embodiment, the pressure relief panel 126 may comprise only the elastomeric material.

[0033] In use, according to one embodiment, the pressure relief panel 126 may be in a first condition during normal use of the ostomy pouch, i.e., when a first, or normal, internal pressure is in the collection chamber 112. The first condition may be a substantially undeformed or unstretched condition. A pressure increase within the collection chamber 112 may be caused by an externally applied force, for example, in response to the wearer bending in a particular manner or leaning or rolling onto the ostomy pouch 100.

[0034] The pressure relief panel 126 may be elastically deformed to a second condition in response to a predetermined internal pressure in the collection chamber 112 being reached or exceeded. In the second condition, the pressure relief panel 126 is stretched, or expanded, in way which reduces or maintains the internal pressure in the collection chamber 112. In one embodiment, the first portion, i.e., the pressure relief panel 126 deforms at a greater rate and/or to a larger extent than the second portion 128, i.e., the film 128.

[0035] When the internal pressure of the collection chamber 112 returns to normal levels, for example, after removal of the external force from the ostomy pouch 110, the pressure relief panel 126 is configured to return to the first condition under the intrinsic elastic return force of the elastomeric material. The pressure relief panel 126 is configured to elastically deform at an internal pressure level below which film herniation, seal failure and/or barrier or skin separation may occur and can elastically deform to an extent where the internal pressure is maintained below such levels. In addition, the pressure relief portion 126 may return to the first condition from the second condition without intervention from the wearer or a caretaker once the internal pressure is returned to a normal level. Thus, an expanded size of the ostomy pouch 100, i.e., when the pressure relief panel 126 is in the second condition, is provided only for the period of time in which the internal pressure exceeds the predetermined level. The ostomy pouch 100 may return to its original size once the pressure falls below the predetermined level and the pressure relief panel 126 returns to the first condition.

[0036] FIGS. 2-7 show ostomy pouches according to different embodiments. The ostomy pouches in the following embodiments may include one or more features that are identical or substantially the same as features described above. Accordingly, such features may be referred to using similar terminology and reference numbers, and further description may be omitted, except where features of the follow ostomy pouches differ from those described above.

[0037] Referring generally to FIGS. 2-7, a size (area), position, and shape of the pressure relief panel may be varied as desired during manufacture. Accordingly, different pressure relief properties may be provided to the ostomy pouch, for example, based on a particular construction of the ostomy pouch and resistance to various internal pressures of the ostomy pouch. That is, the pressure relief panel may be sized, shaped, and positioned so that it elastically deforms based on a predetermined internal pressure. For example, a pressure relief panel having a larger surface area may be elastically deform at a lower internal pressure than a similarly positioned pressure relief panel have a smaller surface area.

[0038] With further reference to FIG. 2, in one embodiment, the ostomy pouch

200 may be a drainable ostomy pouch having a drainage outlet 230 formed at a lower end 232. The pressure relief panel 226 may be formed generally in a rectangular shape. In one embodiment, a length of the pressure relief panel 226 extends in a direction between the lower end 232 and an upper end 234 of the ostomy pouch 200. The pressure relief panel 226 may be substantially centered in a lateral direction on one side, i.e., a body-facing side or outer side, of the pouch wall 210 and spaced from the lower end 232 and the upper end 234. A remaining portion of the pouch wall 210 may be formed by the film 228.

[0039] Referring to FIG. 3, in one embodiment, the ostomy pouch 300 may be a drainable ostomy pouch having a drainage outlet 330 formed at a lower end 332. The pressure relief panel 326 may be formed generally in an oblong shape. In one embodiment, a length of the pressure relief panel 326 extends in a direction between the lower end 332 and an upper end 334 of the ostomy pouch 300. The pressure relief panel 326 may be offset from center in a lateral direction on one side, i.e., a body-facing side or an outer-facing side, of the pouch wall 310 and spaced from the lower end 332 and the upper end 334. A remaining portion of the pouch wall 310 may be formed by the film 328.

[0040] Referring to FIG. 4, in one embodiment, the ostomy pouch 400 may be a drainable ostomy pouch having a drainage outlet 430 formed at a lower end 432. The pressure relief panel 426 may be formed generally in a circular shape. In one embodiment, the pressure relief panel 426 may be offset from center in a lateral direction on one side, i.e., a body-facing side or outer-facing side, of the pouch wall 410 and positioned closer to an upper end 434 than the lower end 432. A remaining portion of the pouch wall 410 may be formed by the film 428.

[0041] Referring to FIG. 5, in one embodiment, the ostomy pouch 500 may be a drainable ostomy pouch having a drainage outlet 530 formed at a lower end 532. The pressure relief panel 526 may be formed generally in a rectangular shape. In one embodiment, a length of the pressure relief panel 526 extends in a lateral direction across the ostomy pouch 500. In one embodiment, the pressure relief panel 526 may extend entirely across the lateral direction of the pouch wall 510 between opposite sides of the seal periphery 518. Further, in one embodiment, the pressure relief panel 526 may be disposed at the upper end 534 of the ostomy pouch 500. In one embodiment, the pressure relief panel 526 may be bound by the sealed periphery 518 at the upper end 534, opposite sides of the sealed periphery 518 at lateral edges of the ostomy pouch 500, and the film 528. In one embodiment, the pressure relief panel 526 may extend across the sealed periphery 518. That is, the sealed periphery 518 may be formed, at least in part, by joining opposed sections of elastic material in a sealed manner. In one embodiment, discrete pressure relief panels 526 may be separated by the sealed periphery 518 on opposite sides, i.e., on the first wall and the second wall, of the ostomy pouch 500. A remaining portion of the pouch wall 510 may be formed by the film 528.

[0042] Referring to FIG. 6, in one embodiment, the ostomy pouch 600 may be a drainable ostomy pouch having a drainage outlet 630 formed at a lower end 632. The pressure relief panel 626 may be formed generally in a rectangular shape. In one embodiment, a length of the pressure relief panel 626 extends in a lateral direction across the ostomy pouch 600. In one embodiment, the pressure relief panel 626 may extend entirely across the lateral direction of the ostomy pouch between opposed sides of the sealed periphery 618. The pressure relief panel 626 may be spaced from the lower end 632 and the upper end 634. In one embodiment, the pressure relief panel 626 may extend around the lateral portions of the sealed periphery 618 so that the panel 626 extends on opposite sides of the ostomy pouch 600, i.e., on the first wall and the second wall. In another embodiment, discrete pressure relief panels 626 may be formed on opposite sides of the ostomy pouch 600 separated by the sealed periphery 618. In one

embodiment, a portion of the sealed periphery 618 may be formed by joining opposing sections of the elastomeric material together in a seal manner. In one embodiment, the pressure relief panel 626 may be positioned closer to the upper end 634 than the lower end 632. A remaining portion of the pouch wall 610 may be formed by the film 628.

[0043] Referring to FIG. 7, in one embodiment, the ostomy pouch 700 may be a drainable ostomy pouch having a drainage outlet 730 formed at a lower end 732. The pressure relief panel 726 may be formed generally in a trapezoidal shape, or similar shape that substantially matches a peripheral contour of the lower end 732. For example, such a pressure relief panel 726 may vary in width along a direction extending between the lower end 732 and the upper end 734. The pressure relief panel 726 may positioned closer to the lower end 732 than the upper end 734. The pressure relief panel 726 may be substantially centered in a lateral direction on one or both sides, i.e., a body-facing side and/or an outer-facing side, of the pouch wall 710. A remaining portion of the pouch wall 710 may be formed by the film 728.

[0044] The present disclosure is not limited to the specific examples above. For example, it is envisioned that differently sized, shaped, or positioned pressure relief panels could be implemented in the embodiments above. Further, it is envisioned that an ostomy pouch may include a plurality of pressure relief panels. It is also envisioned that one or more pressure relief panels could be included on both the first wall and the second wall. The pressure relief panels of the first wall may be sized, shaped and positioned in a mirrored relationship with the one or more relief panels of the second wall. Alternatively, one of the first wall and the second wall may include differently sized, shaped, and/or positioned pressure relief panels, or a different number of pressure relief panels than the other of the first wall and the second wall. In some

embodiments, it is envisioned that the pressure relief panels may be positioned at locations of the pouch wall where stress concentrations are expected in response to increased pressure within the ostomy pouch.

[0045] It is understood that the relative directions described above, e.g,“upward,”

“downward,”“upper,”“lower,”“above,”“below,” are used for illustrative purposes only and may change depending on an orientation of the ostomy pouch and/or the patient. Accordingly, this terminology is non-limiting in nature. In addition, it is understood that one or more various features of an embodiment above may be used in, combined with, or replace other features of a different embodiment described herein.

[0046] All patents referred to herein, are hereby incorporated herein in their entirety, by reference, whether or not specifically indicated as such within the text of this disclosure.

[0047] In the present disclosure, the words“a” or“an” are to be taken to include both the singular and the plural. Conversely, any reference to plural items shall, where appropriate, include the singular.

[0048] From the foregoing it will be observed that numerous modifications and variations can be effectuated without departing from the true spirit and scope of the novel concepts of the present invention. It is to be understood that no limitation with respect to the specific embodiments illustrated is intended or should be inferred. The disclosure is intended to cover by the appended claims all such modifications as fall within the scope of the claims.

Claims

1. An ostomy pouch comprising:

a pouch wall defining a collection chamber therein, the pouch wall having a first portion and a second portion;

an inlet opening configured to receive a discharge for collection in the collection chamber; and

wherein the first portion is a pressure relief panel formed from an elastomeric material and configured to elastically deform in response to a predetermined pressure in the collection chamber.

2. The ostomy pouch of claim 1, wherein the pouch wall comprises a first wall and a second wall joined to one another along their respective peripheries to form a sealed periphery.

3. The ostomy pouch of claim 2, wherein the first wall is a body -facing side and the second wall is an outer-facing side, and the pressure relief panel is formed in the second wall.

4. The ostomy pouch of any of claims 1-3, wherein the second portion is a film.

5. The ostomy pouch of claim 4, wherein the film comprises a thermoplastic polymer material.

6. The ostomy pouch of any of claims 4 and 5, wherein the film is a multilayer film.

7. The ostomy pouch of any of claims 1 through 6, wherein the second portion does not overlap or coextend with the first portion.

8. The ostomy pouch of any of claims 1 through 7, wherein the first portion has a lower modulus of elasticity than the second portion.

9. The ostomy pouch of any of claims 1 through 8, wherein the first portion is formed only from the elastomeric material.

10. The ostomy pouch of any of claims 1 through 9, further comprising a drainage outlet configured for draining the discharge from the collection chamber.

11. The ostomy pouch of any of claims 1 through 10, wherein the first portion is rectangular in shape.

12. The ostomy pouch of any of claims 1 through 10, wherein the first portion is circular in shape.

13. The ostomy pouch of any of claims 1 through 10, wherein the first portion is oblong in shape.

14. The ostomy pouch of any of claims 1-10, wherein the first portion is substantially trapezoidal in shape.

15. The ostomy pouch of any of claims 1 through 14, wherein the first portion extends from one lateral side of the pouch wall to another lateral side of the pouch wall.

16. The ostomy pouch of any of claims 1 through 14, wherein the first portion extends along an upper portion of the pouch wall.

17. The ostomy pouch of any of claims 1 through 14, wherein the first portion is formed at a lower portion of the pouch wall.

18. The ostomy pouch of any of claims 1 through 17, wherein the pouch wall comprises a plurality of first portions.

19. The ostomy pouch of any of claims 1 through 18, wherein the first portion is in a first condition when a pressure in the collection chamber is below the predetermined pressure is in a second condition when elastically deformed in response to the pressure in the collection chamber exceeding the predetermined pressure.