Ostomy Pouch Closure System

Abstract

A closure member for a drainable stoma appliance, the stoma appliance comprising a bodyside wall and a non-bodyside wall sealed together along a portion of their respective peripheries to define a collection cavity, and a neck terminating at a drainage opening. The closure member comprises a first portion on the bodyside wall, the bodyside wall comprising first and second closure members, the first and second closure members having a gap between each other, a second portion on the non-bodyside wall, the non-bodyside wall comprising third and fourth closure members. In an open state, the neck is unfolded, and in a closed state, the first closure member is folded over the third closure member with loose folds, and the first, second and third closure members are folded over the fourth closure member, the first closure member being proximal to the fourth closure member and forming a seal between the third and fourth closure members with tight folds.

Description

Technical Field

[0001] The following description generally relates to systems for stoma pouch closures, and more particularly to drainable stoma pouch closure systems.

Background Art

[0002] Ostomy pouches for collecting bodily excretions are used by patients who have undergone surgeries such as colostomy, ileostomy, or urostomy. The pouch typically includes flat, opposing sidewalls that are secured to each other along their peripheral edges to define a collection cavity. An opening for receiving the stoma is formed in one of the sidewalls, and the pouch is provided with securing means or a system such as an adhesive barrier to secure the pouch to the user so that bodily excretions discharged through the stoma are received within the cavity.

[0003] Some stoma pouches may be single-use designed closed-end pouches, in which case the entire peripheral edge is sealed to each other and the pouch is discarded after being substantially filled with excrement. Other stoma-type pouches are drainable pouches that include a discharge opening at the lower end that can be closed during collection of excrement and may be opened to discharge bodily excrement from the pouch after the period of use. Such drainable pouches are disclosed, for example, in U.S. Patent No. 3,523,534, Nolan and U.S. Patent No. 4,411,659, Jensen et al. The disclosures of which are hereby incorporated herein by reference in their entirety

[0004] The outlet of a drainable pouch is typically formed at the end. The end of the neck portion has closing means (or a closing system) for maintaining the outlet in a sealed state until excrement is discharged from the pouch. Some closing systems include clamps such as those of the aforementioned Nolan patent, or devices such as conventional wire ties or wraps for securing the neck portion in a wound-up state.

[0005] The pouches to be discharged should be such that there is no risk of soiling people, clothes or the surroundings and the discharge is easy. The pouch should also be easy to close firmly after discharge and should be washable so that it can be closed again after discharge. This substantially reduces the risk of unpleasant odors. Most importantly, the closure system should provide a secure seal to minimize the risk of leakage when closed.

[0006] A number of different closure system solutions are known that facilitate closure, washing and discharge. For example, systems including an upwardly foldable portion of the neck having a number of integral spring-like biasing members include U.S. Patent No. 8,672,907, Villefrance et al. U.S. Patent No. 7,879,015 Friske et al. These are assigned to the applicant together with this application and are hereby incorporated by reference in their entirety.

[0007] Other dischargeable pouches having an integral closure system include U.S. Patent No. 9,011,395 Friske etal. The patent includes four closure members and a two-piece fixing system. One closure member is provided at the body-side pouch outlet and three closure members are provided at the distal-side pouch outlet. The patent is assigned to the applicant and is hereby incorporated by reference in its entirety. SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION

[0008] All of these systems function well, but there are significant tolerances regarding the positioning of stiffening ribs that must be met for the closure system to function properly.

[0009] Accordingly, it is desirable to provide a stoma appliance, such as a stoma pouch with a closure system that uses stiffening ribs to effect proper closure. Desirably, such a system provides secure closure with less dependence on the positioning of the stiffening ribs relative to each other on the pouch film. **Means for Solving the Problem**

[0010] According to one embodiment, a drainable stoma appliance includes side walls of a flexible sheet material, which are sealed to each other along a part of the periphery of each side wall to define a collection cavity. The side walls are a body-side wall and a non-body-side wall. An inlet is formed in the body-side wall.

[0011] The side walls define a neck portion that extends downward and terminates at a discharge opening. At the discharge opening, the side walls are not sealed to each other. The discharge opening is closed by folding the neck portion upward and opened by expanding the neck portion downward to discharge the contents from the cavity.

[0012] The closure system includes a first part and a second part. The first part is on the body-side wall and the second part is on the non-body-side wall. The first part includes a first closure member and a second closure member. The first closure member is proximal to the discharge opening and the second closure member is distal to the discharge opening. The first and second closure members define a gap therebetween. The second part of the closure system is on the non-body-side wall and includes a third closure member and a fourth closure member.

[0013] In the open state, the neck portion is deployed. In the closed state, the first closure member is folded onto the third closure member with a loose fold, the first, second and third closure members are folded onto the fourth closure member, the first closure member is proximal to the fourth closure member with a tight fold, and a seal is formed between the third closure member and the fourth closure member. The neck portion may be fixed in the closed state using a fastening system.

[0014] In an embodiment, the first, second, third, and fourth closure members are formed from a material such as a stiff and flexible spring. The material may be a polymeric material. Suitable polymeric materials include polyethylene (PE) and ethylene vinyl acetate (EVA).

[0015] In an embodiment, the first, second, third, and fourth closure members include priority fold lines formed therein. In one embodiment, the priority fold lines are slits or predefined grooves formed in a portion of the first, second, third, and fourth closure members. In the open state, the priority fold lines in the first and second closure members are aligned, the priority fold lines in the second and third closure members are aligned, and the priority fold lines in the third and fourth closure members are aligned. In an embodiment, the priority fold lines are predetermined grooves of the closure members.

[0016] In an embodiment, the first and third closure members partially overlap each other on opposite sides of the discharge port.

[0017] In an embodiment, the first and second closure members are attached to the side wall on the body side such that a part of each of the first and second closure members is adhered to the side wall on the body side, and another part of each of the first and second closure members is not adhered to the side wall on the body side. The third and fourth closure members can be attached to the side wall on the non-body side such that a part of each of the third and fourth closure members is adhered to the side wall on the non-body side, and another part of each of the third and fourth closure members is not adhered to the side wall on the non-body side.

[0018] The parts of the first and second closure members that are not adhered to the side wall on the body side are proximal to each other, and the parts of the third and fourth closure members that are not adhered to the side wall on the non-body side are proximal to each other.

[0019] Other objects, features, and advantages of the disclosure will become apparent in conjunction with the following description and the accompanying drawings. Like numbers refer to like parts, elements, components, steps, and processes.

Brief Description of the Drawings

[0020]

Figure 1

Figure 2

Figure 3

Figure 4A

Figure 4B

Figure 4C

Figure 5

Figure 6

DETAILED DESCRIPTION OF THE INVENTION

[0021] The present disclosure is susceptible to various embodiments, is shown in the drawings, and describes one or more embodiments. However, in the following, the present disclosure should be regarded as merely exemplary and is not intended to be limited to the specific embodiments described or illustrated.

[0022] Figure 1 shows a drainable stoma appliance or pouch 10 according to one embodiment, showing a body-facing side 12 and a stoma pouch closure system 14. The drainable pouch includes an outer wall (or non-body side wall) 16 and a body-side wall 12, which are joined along their peripheries 18 to define a collection cavity 20 for collecting stoma effluent. The pouch 10 includes an opening 22 for receiving the stoma and member 24, and the member 24 secures the pouch to the user, with the member 24 surrounding the opening 22. The member 24 can be, for example, a one-piece barrier or a two-piece barrier including a snap-fit ring (not shown). One-piece and two-piece barriers will be understood by those skilled in the art.

[0023] The drainable pouch 10 also has a downwardly extending neck portion 26, terminating in a discharge opening or outlet 28 for discharging the contents collected within the cavity 20 after the period of use. The outlet 28 is closed by bending the neck portion 26 upwardly during use and securing it in the upwardly bent position.

[0024] The side walls 12, 16 can be a single layer or multi-layer film, such as a suitable flexible sheet material, e.g., a polymer film. Each of the side walls 12, 16 can be formed from one continuous flexible film to define the entire pouch 10 including the neck portion 26. Alternatively, the walls 12, 16 of the neck portion 26 can be formed from a flexible film different from the walls 12, 16 of the pouch 10 body. That is, the walls of the neck portion 26 can be formed from a polymer film different from the walls of the pouch body.

[0025] Referring to Figure 2, a bottom body-side side view of the pouch 10 is shown. The peripheral edges 18 of the walls 12, 16 are sealed along their respective sides, but not sealed at the bottom as indicated by reference numeral 32, and this unsealed area defines the outlet 28 through which stoma effluent can be emptied from the pouch 10.

[0026] The closure system 14 includes a first portion 34 of the body-side sidewall 12 (as shown in FIG. 3) and a second portion 36 of the non-body-side sidewall 16. The first and second closure members 38, 40 on the body side are positioned on the body-side sidewall 12, with the first closure member 38 proximal to the discharge port 28 and the second closure member 40 distal from the discharge port 28. The first and second closure members 38, 40 on the body side are spaced apart from each other, defining a gap 42 therebetween. The first and second body-side closure members 38, 40 have a structure (a film thinner than a thin film) such that a user can hold and control the pouch neck portion 26 to open the discharge port 28. In some embodiments, the first portion 34 can include only one body-side closure member 38. In one embodiment, the second body-side closure member 40 may be sized to fit inside the peripheral seal 18 such that the pouch neck portion 26 can open fully without making a sharp angle.

[0027] Referring to FIG. 3, a view of the non-body-side sidewall 16 of the lower portion 30 of the pouch 10 is shown. Similar to the body-side sidewall 12, the non-body-side sidewall 16 includes closure members (44), (46) referred to as the third and fourth closure members, with the non-body-side third closure member 44 proximal to the discharge port 28 and the fourth closure member 46 distal from the discharge port 28. In one embodiment, the third and fourth (non-body-side) closure members 44, 46 abut each other.

[0028] In embodiments, the closure members 38, 40, 44, 46 are formed from a rigid or flexible springy polymeric material. The members 38, 40, 44, 46 are flat and arranged in a straight parallel relationship with each other. The material is somewhat rigid but can be bent or flexed to open the discharge port 28. That is, in the relaxed state, the closure members 38, 40, 44, 46 maintain the opening 28 in a relatively closed state. However, when the ends 48 of the members 38, 40, 44, 46 are both crushed together (the center line A of the discharge port 28 28When pressed towards it), members 38, 40, 44, 46 bend or curve outward to open the discharge port 28. Suitable materials for the closing members 38, 40, 44, 46 include polyethylene (PE), ethylene vinyl acetate (EVA), and the like.

[0029] In an embodiment, to facilitate bending or curving outward, the closing members 38, 40, 44, 46 can include preferential fold lines 50 within the members 38, 40, 44, 46. The preferential fold lines 50 can be formed as grooves or partial slits predefined in the members 38, 40, 44, 46, and the grooves or slits 50 are partial in that they do not completely penetrate the members 38, 40, 44, 46. In an embodiment, the preferential fold lines 50 can be formed as predetermined grooves formed in the members 38, 40, 44, 46. As shown in FIGS. 2 and 3, the fold lines 50 within the body-side members 38, 40 are closer to each other than the fold lines 50 within the non-body-side members 44, 46, and the fold lines within the first and third members 38, 44 are closer to each other than the fold lines 50 within the second and fourth members 40, 46. In an embodiment where the second member 40 overlaps a portion of the third member 44, the fold line 50 within the second member 40 and the fold line 50 within the third member 44 can overlap each other. In this way, when the ends 48 of the members 38, 40, 44, 46 are squeezed towards each other to open the discharge port 28, the fold lines 50 are aligned with each other as a whole to form a funnel-shaped discharge portion for the pouch 10.

[0030] Next, with reference to FIGS. 4A - 4C, the folding of the pouch neck portion 26 closing the discharge port 28 will be described. FIG. 4A shows the pouch 10 with the neck portion 26 deployed. As described above, the body-side closing members 38, 40 are separated from each other by the gap 42. The non-body-side closing members 44, 46 may be in an abutting relationship.

[0031] Referring to FIG. 4B, as the first fold (shown at 52) is made, the closure member 38 is folded onto the third closure member 44. The space or gap 42 between the first and second members 38, 40 allows for a loose fold that depends on the size of the gap 42 between the members 38, 40.

[0032] Next, referring to FIG. 4C, as the second fold (shown at 54) is made, the first, second members 38, 40 and the third member 44 are folded onto the fourth member 46. The tight fold and stretching of the pouch material at the fold 54 between the third and fourth members 44, 46 establishes the seal of the pouch 10. The relationship between the thickness of the members, e.g., members 40, 44, and the size of, e.g., the gap 42, generates the tension required to establish the closure seal without high placement tolerances for the members 38, 40, 44, 46.

[0033] In embodiments, the closure members 38, 40, 44, 46 are adhered to the pouch 10, for example, by an adhesive 60, heat sealing, etc. In embodiments, the members 38, 40, 44, 46 need not be completely adhered to the pouch 10. As seen in FIG. 5, along the length direction of the pouch, i.e., the center line A 28 of the discharge port 28, it is not necessary for the entire closure members 38, 40, 44, 46 to be completely adhered to the pouch 10. The portions indicated by reference numeral 56 of the first member 38 and the second member 40 that are close to each other may not be fixed to the pouch 10, or the members 38, 40 may be completely adhered to the pouch 10. The portions indicated by reference numeral 58 of the third and fourth members 44, 46 that are close to each other may not be adhered to the pouch 10. This allows for elastic deformation, e.g., stretching, of the film of the pouch 10 between the third and fourth members 44, 46 (as seen in FIG. 4C) when folding (such as at the fold line 54).

[0034] Unlike known closure systems, it will be appreciated that closure system 14 does not rely at all on positional tolerances between the first and second (body-side) 38, 40 and the third and fourth (not body-side) 44, 46 closure members. That is, the alignment of the body-side closure members 38, 40 and the non-body-side closure members 44, 46 is not as important as in conventional known closure systems. The closure system 14 of the present invention uses loose folds 52 in the first and second (body-side) members 38, 40 and tight folds 54 between the third and fourth (non-body-side) members 44, 46, so it does not depend on the exact position of the first and second members 38, 40 relative to the third and fourth members 44, 46 and does not require exact or tight tolerances. Also, the alignment of the first and second members 38, 40 relative to the third and fourth members 44, 46 is not important.

[0035] As is well known, although not shown in FIGS. 1-5, in the art, the stoma pouch closure system 14 may also include, for example, a fastening system for fixing the pouch neck portion 26 in a raised and closed position after the second fold, as shown in FIG. 4C. In some embodiments, the stoma pouch closure system 14 can include a two-piece fastening system with first and second fastener strips such as hook and loop fasteners. In one embodiment, the closure system 14 can include a flap 70 attached to the non-body-side sidewall 16 adjacent to the fourth closure member 46, the flap including a first fastener strip, and the second closure member 40 including a second fastener strip configured to engage the first fastener strip and secure the folded neck portion in a closed position as shown in FIG. 6. Alternatively, the second closure member 40 may be replaced with a second fastening strip. In another embodiment, the second fastener strip may be attached to the body-side sidewall 12 adjacent to the second closure member 40, where the pouch neck portion 26 is folded three times (the third fold after the second fold shown in FIG. 4C) and configured to be fixed in a closed position by engaging the first fastener strip provided on the flap 70 with the second fastener strip.

[0036] All patents referred to in this specification are hereby incorporated by reference into this specification, whether or not specifically shown in the text of this disclosure. In this disclosure, the words "a" or "an" shall be taken to include both the singular and the plural. Conversely, references to a plurality of items shall, where appropriate, include the singular. Additionally, the various features described with respect to any of the above embodiments can be used, incorporated, or replaced with features in any of the other above embodiments.

[0037] From the foregoing, numerous changes and modifications can be made without departing from the true spirit and scope of the novel concepts of the present invention. It is to be understood that the specific embodiments shown are not intended, or should not be presumed, to be limiting. This disclosure is intended that all such changes be covered by the claims and be covered by the claims.

Claims

1. A stoma appliance capable of drainage, comprising: Side walls of a flexible sheet material that are sealed to each other along a part of their respective peripheral edges to define a collection cavity, said side walls being a body-side wall and a non-body-side wall, said side walls extending downward and defining a neck portion that terminates at a discharge port, said side walls not being sealed to each other at the discharge port, said discharge port being closed by folding the neck portion upward, and the discharge port being opened by unfolding the neck portion downward to discharge contents from the cavity; and An inlet of the body-side wall; A closure system, said closure system comprising: A first part of the closure system of the body-side wall, a second part of the closure system of the non-body-side wall, and a fastening system; The first part of the closure system includes a first closure member and a second closure member, the first closure member being disposed adjacent to the discharge port, the second closure member being disposed away from the discharge port, the first closure member and the second closure member defining a gap therebetween; The second part of the closure system of the non-body-side wall includes a third closure member and a fourth closure member; In an open state, the neck portion is unfolded, and in a closed state, the first closure member is folded onto the third closure member with the gap as a fold line, the first, second, and third closure members are folded onto the fourth closure member, the first closure member is positioned directly above the fourth closure member, the non-body-side side walls of the third closure member and the fourth closure member elastically deform to form a seal between them, and the neck portion is fixed in the closed state using the fastening system. A stoma appliance.

2. The stoma appliance according to claim 1, wherein the first, second, third, and fourth closure members are formed of a flexible spring-like material.

3. The stoma appliance according to claim 2, wherein the material is a polymer material.

4. The stoma appliance according to claim 3, wherein the polymer material is polyethylene (PE) or ethylene vinyl acetate (EVA).

5. The stoma appliance according to claim 1, wherein the first, second, third, and fourth closure members have preferential fold line formed therein.

6. The stoma appliance according to claim 1, wherein the preferential fold line is a predetermined groove formed in a part of the first, second, third, and fourth closure members.

7. The stoma appliance according to claim 1, wherein the priority fold line is a slit formed in a part of the first, second, third, and fourth closing members.

8. The stoma appliance according to claim 5, wherein when in the open state, the priority fold lines in the first and second closing members are aligned, the priority fold lines in the second and third closing members are aligned, and the priority fold lines in the third and fourth closing members are aligned.

9. The stoma appliance according to claim 1, wherein when in the open state, the second and third closing members are located on the side opposite to the discharge port and partially overlap each other.

10. The stoma appliance according to claim 1, wherein the first and second closing members are attached to the side wall on the body side, a part of each of the first and second closing members is adhered to the side wall on the body side, and another part of each of the first and second closing members is not adhered to the side wall on the body side.

11. The stoma appliance according to claim 1, wherein the third and fourth closing members are attached to the side wall on the non-body side, a part of each of the third and fourth closing members is adhered to the side wall on the non-body side, and another part of each of the third and fourth closing members is not adhered to the side wall on the non-body side.

12. The stoma appliance according to claim 10, wherein the third and fourth closing members are attached to the side wall on the non-body side, a part of each of the third and fourth closing members is adhered to the side wall on the non-body side, and another part of each of the third and fourth closing members is not adhered to the side wall on the non-body side.

13. The stoma appliance according to claim 10, wherein the parts of the first and second closing members that are not adhered to the side wall on the body side are proximal to each other.

14. The stoma appliance according to claim 11, wherein each of the parts of the third and fourth closing members that are not adhered to the side wall on the non-body side is proximal to each other.

15. The stoma appliance according to claim 1, further comprising a two-piece connecting device for fixing to the user's body.

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