Stoma discharge receiving apparatus

Abstract

The apparatus includes a head member 2 having a flange portion which is sealably securable to skin surrounding a stoma. A connector 3 releasably connects the head member to a flexible conduit 4 leading to a collection bag 5 which is removably supported in a holder 6 attached to the wearer. The connector 3 incorporates a non-return valve to prevent backflow into the stoma. Material discharged through the stoma travels along a closed path from the head member into the collection bag via the connector and flexible conduit. The apparatus reduces the risk of leaks developing as the collection bag fills.

Description

[0001] STOMA DISCHARGE RECEIVING APPARATUS

[0002] TECHNICAL FIELD OF THE INVENTION

[0003] This invention relates to receiving apparatus for collecting material discharged from a stoma.

[0004] BACKGROUND

[0005] A stoma is an opening in the abdominal wall to which the digestive tract has been surgically attached. An external bag can then be attached to the abdomen to collect material discharged from the stoma. People may require a stoma for a variety of reasons. In Crohn's disease for example, the diseased colon (large intestine) may be surgically bypassed in a procedure known as a colostomy. The collection bag is then referred to as a colostomy bag. More infrequently, in treatment of ulcerative colitis for example, the ileum (small intestine) may be connected to a stoma so that digestive matter does not need to pass through the colon. In this case the procedure is called an ileostomy and the collection bag is referred to as an ileostomy bag. Two types of collection bag are in general use. In one type the bag is provided with an opening which is adhesively attached to the skin surrounding the stoma. The bag is then detached and disposed of at regular intervals. Another type of bag comprises an annular flange which is adhered to the skin for a longer period, usually one or two days, and a detachable pouch used to catch the digestive waste can be replaced at shorter intervals. Detachable bags are normally single use, but drainable bags which can be emptied through a bottom opening and reused are also available.

[0006] In such known collection systems the bag hangs from the skin and users find that the weight of the contents often causes the adhesive to fail as the bag fills up, resulting in frequent leaks. Active users also find that the position of the bag on the abdomen is inconvenient when engaged in sports or manual work for example.

[0007] CN215192800-U and CN215131278-U both describe stoma discharge collecting devices which include a head member which is sealably securable to the skin surrounding a stoma, a flexible conduit releasably connected to the head member, and a collection bag joined to the flexible conduit. Material discharged through the stoma travels along a closed path from the head member into the collection bag via the flexible conduit.

[0008] In CN215192800-U the head member has an outlet which incorporates a releasable connector and a shut-off valve which can be manually operated to close the opening during disconnection of the flexible conduit. This known device still requires a considerable amount of manual intervention to reduce leaks and spillages. An exhaust plug is provided to allow gases to be released from the head member, and the collection bag is intended to be periodically emptied through a discharge pipe while the bag remains attached to the user's leg. The user must also ensure that the shut-off valve is fully closed before disconnecting the flexible conduit if it is desired to replace a filled drainage bag.

[0009] SUMMARY OF THE INVENTION

[0010] When viewed from one aspect the present invention proposes stoma discharge collection apparatus which includes a head member including an outlet, a flexible conduit, a connector to releasably connect the flexible conduit to the outlet, and a collection bag joined to the flexible conduit. The outlet includes a non-return valve to prevent back-flow of material discharged from the stoma.

[0011] A preferred form of non-return valve includes flexible impervious wall members which are disposed face-to-face and resiliently urged into a normal state such that there is little or no through passage between them. Means are provided holding the wall members spaced from one another to define an inlet for ingress of fluid to the interface of those members. In-flowing fluid forces the members apart to permit flow between them whereas fluid flow in the opposite direction is prevented by mutual surface contact between the members.

[0012] In an embodiment the discharge collection apparatus includes a holder which is attachable to a wearer to removably receive the collection bag.

[0013] The holder supports the weight of the bag as it gradually fills with discharged material, so that the head member is relieved of stresses caused by the weight of the discharge. Material discharged through the stoma travels along a closed path from the head member into the collection bag via the connector and flexible conduit. The risk of leakage is substantially reduced with greater comfort for users.

[0014] BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The following description and the accompanying drawings referred to therein are included by way of non-limiting example in order to illustrate how the invention may be put into practice. In the drawings:

[0016] Figure 1 is an outline of a person wearing stoma discharge collection apparatus; Figure 2 is a front view of the head member of the collection apparatus;

[0017] Figure 3 is a side view of the head member;

[0018] Figure 4 is another front view of the head member but showing some of the internal configuration in dashed outline;

[0019] Figure 5 is the longitudinal section A-A at the position indicated in Fig. 4

[0020] Figure 6 is a similar sectional view to Fig. 5, but showing a modified head member of the collection apparatus;

[0021] Figure 7 is a longitudinal section B-B through part of the head member at the position indicated in Fig. 6.

[0022] DETAILED DESCRIPTION OF THE DRAWINGS

[0023] Referring firstly to Fig. 1, the drawing depicts a person P with a stoma. The person is wearing stoma discharge collection apparatus 1 which includes a head member 2, a two-part connector 3, a flexible conduit 4, and a collection bag 5 which is removably supported on the wearer's thigh by a holder 6. Referring to Fig.s 2 and 3, the head member 2 comprises a one-piece moulding 21 formed of a soft, flexible material approved for medical use such as silicone rubber. The moulding includes a shallow cup-shaped antechamber 22 with an annular flange 23 surrounding an inlet opening 24. An integral outlet 25 projects from one side of the antechamber 22. A flexible fixing disc 26 is bonded to the flange 23 for securing the head member to the skin surrounding a stoma. The fixing disc incorporates a non-allergenic adhesive which is suitable for firmly attaching the head member to the skin of the user and which may be protected by a peelable backing prior to use. The outlet 25 is of shallow generally rectangular cross section and carries a hand grip 27 which may be integral with or bonded to the outlet. The hand grip is also of shallow generally rectangular cross-section, the shorter opposite sides of which are formed with a series of ridges 28 to facilitate gripping of the head member.

[0024] As will be explained shortly, the end portion of the outlet 25 beyond the hand grip 27 forms one part of the connector 3 which provides a quick and secure way of connecting the head member 2 with the flexible conduit 4. The conduit 4 is also of generally rectangular cross-section and is preferably formed of a highly flexible, preferably transparent, low friction plastic. Examples of suitable materials include PTFE or similar fluoroplastics, super hydrophobic non-wettable plastics, and LiquiGlide trade mark) low friction plastic.

[0025] Referring to Fig.s 4 and 5, the end portion of the outlet 25 includes a non-return valve in the form of a flap 29 (shown in its open position) which is pivoted to the shorter opposite sides of the outlet. The valve prevents backflow of discharged material into the stoma in the event of pressure due, for example, to compression of the conduit 4 or bag 5 in use. The end portion of the outlet 25 is formed with an encompassing ridge 30 which is followed by grooves 31 and a chamfered end 32, dimensioned to allow the end of the conduit 4 to be slid onto the outlet, whilst holding the hand grip 27 , until the conduit abuts the ridge 30. This end is then secured by a tubular second part 33 of connector 3 which is slid over the conduit 4 prior to connection to the head member. This second connector part 33 is also of generally rectangular cross-section and has a trailing end 34 which is dimensioned such that the conduit 4 is tightly gripped between the end 34 and the outlet 25. An enlarged leading end 35 facilitates pushing the connector part 33 over the ridge 30 until an inwardly directed chamfered rib 36 engages behind the ridge 30 to securely hold the conduit on the outlet 25.

[0026] The conduit 4 is preferably integrally formed with the collection bag 5, which is of a conventional flattened configuration, again being of a highly flexible low friction material. The collection bag 5 is slid into the holder 6, which may be of the kind used for holding urine collection bags, with an open upper end and secured around the wearer's leg using straps secured by buckles or hook-and-loop fastenings for example. Liquid material discharged from the stoma thus travels along a closed path from the head member 2 into the collection bag 5 via the connector 3 and flexible conduit 4, with little or no risk of leakage. The holder 6 supports the weight of the bag as it gradually fills with discharged material, so that the head member is relieved of stresses caused by the weight of the discharge.

[0027] When the bag fills to between one third and one half of its capacity the flexible conduit 4 can be disconnected from the head member 2 by holding the hand grip 27 and pulling the tubular part 33 off the outlet 25 to release the conduit 4. The bag can then be emptied and easily refitted or replaced with an new bag as required.

[0028] The non-return valve 29 could take other forms, such as valves formed from opposing flexible webs which meet at an angle, ball valves etc. Fig.s 6 and 7 show a modified form of the head member 2 which incorporates a preferred form of non-return valve 40. The structure of the head member is otherwise as described above. The valve 40 comprises a one-piece thinwalled impervious elastomeric tube, e.g. medical grade silicone rubber, and is located inside the tubular outlet 25. The tube 40 comprises two opposing flat wall members 41 and 42 which are connected to each other along opposite edges 43 and 44 extending along the length of the tube. The tube is manufactured in such a way that, in its normal relaxed state, the flat walls 41 and 42 are disposed close to each other and, under light pressure, lie in mutual face-to-face contact due to the resilience of the elastomeric material, forming a single slit opening 50. Towards the upper end of the tube 40, the walls 41 and 42 diverge and thicken to define an inlet region 45 with a generally rectangular inlet opening 46. In this embodiment the inlet region is sealably held to the inside of the outlet 25 abutting an annular flange 47, e.g. by use of a suitable adhesive or other fixing means.

[0029] Liquid material which is discharged from the stoma into the outlet 25 enters the tube 40 through the inlet opening 46 and forces the flat walls 41 and 42 to move apart permitting unimpeded flow into the flexible conduit 4 and collection bag 5. However, fluid flow in the opposite direction is prevented by the close surface contact between the walls 41 and 42. Such backflow exerts increasing pressure on the external surfaces of the two walls 41, 42 and urges them towards each other preventing flow of material back towards the stoma.

[0030] The opening and closing pressure of the non-return valve may be varied by changing the thickness of the opposing edges of the two walls along the slit opening 50. If, for example, the said edges are bounded by opposing ribs 48 and 49 as shown, the opening pressure will be greater than if the ribs are omitted but the chances of the valve being forced open by high backpressure may be lessened.

[0031] In preferred embodiments at least part of the closed flow path from the head member 2 to the collection bag 5, especially the non-return valves 29 and 40, have an internal hydrophobic coating. A preferred coating has a static contact angle to water of at least 120°. Most preferably a superhydrophobic coating is used which has a static contact angle to water of at least 150°. Such coatings are highly effective for repelling the discharge from a stoma and significantly reduce the chance of back-flow and leakages.

[0032] It is also noted that the walls 41, 42 of the non-return valve 40 could be arranged to provide more than one slit, for example with an X-shaped opening. Furthermore, although the area of face-to-face contact provides good resistance to back-flow with a low forward opening pressure the area of contact between the opposed walls 41 and 42 could be substantially reduced so that the slit opening 50 leads directly into the divergent portion.

[0033] Whilst the above description places emphasis on the areas which are believed to be new and addresses specific problems which have been identified, it is intended that the features disclosed herein may be used in any combination which is capable of providing a new and useful advance in the art.

Claims

AMENDED CLAIMS received by the International Bureau on 15 August 2025 (15.08.2025)1. Stoma discharge collection apparatus:- a head member (2) having a flange portion (23) which is sealably securable to the skin surrounding a stoma, said head member including an outlet (25);- a flexible conduit (4);- a connector (3) to releasably connect the flexible conduit to the outlet (25);- a collection bag (5) joined to the flexible conduit; whereby material discharged through the stoma travels along a closed path from the head member into the collection bag via the connector and flexible conduit; wherein the outlet (25) includes a non-return valve (29, 40) which is opened by pressure of material discharged from the stoma to permit said material to flow into the flexible conduit (4) and is closed by pressure of material flowing in the opposite direction thereby preventing back-flow of material towards the stoma.

2. The stoma discharge collection apparatus of claim 1 wherein the non-return valve (40) comprises flexible wall members (41, 42) which define a slit opening (50) which is resiliently urged into a normally-closed state,3. The stoma discharge collection apparatus of claim 2 wherein the flexible wall members (41, 42) comprise flatportions adjacent to the slit opening (50) which are disposed in face-to-face contact.

4. The stoma discharge collection apparatus of claim 2 wherein the flexible wall members (41, 42) diverge away from the slit opening (50).

5. The stoma discharge collection apparatus of claim 2 wherein the non-return valve (40) comprises an inlet portion (45) which is sealably held to the inside of the outlet (25).

6. The stoma discharge collection apparatus of claim 1 wherein the connector (3) has a first part which comprises an end portion of the outlet (25) and a tubular second part (33) which is slidably received over the first part (25).

7. The stoma discharge collection apparatus of claim 6 wherein the first part (25) of the connector (3) is dimensioned to receive an end portion of the flexible conduit (4) on said first part and is formed with an external ridge (30) to abut an end of the flexible conduit (4).

8. The stoma discharge collection apparatus of claim 7 wherein the tubular second part (33) has a trailing end (34) which is dimensioned such that the conduit (4) is gripped between the first part (25) and the trailing end (34).

9. The stoma discharge collection apparatus of claim 7wherein the tubular second part (33) has an inwardly directed locking rib (36) which engages behind the external ridge (30).

10. The stoma discharge collection apparatus of claim 6 wherein the outlet (25) carries a hand grip (27).

11. The stoma discharge collection apparatus of claim 1 wherein the conduit (4) is of generally rectangular cross-section.

12. The stoma discharge collection apparatus of claim 1 wherein the conduit (4) is integrally formed with the collection bag (5).

13. The stoma discharge collection apparatus of claim 1 wherein at least part of said closed path from the head member to the collection bag has a hydrophobic coating with a static contact angle to water of at least 120°.

14. The stoma discharge collection apparatus of claim 1 wherein at least part of said closed path from the head member to the collection bag has a superhydrophobic coating with a static contact angle to water of at least 150°.

15. The stoma discharge collection apparatus of claim 1 which includes a holder (6) which is attachable to a wearer to removably receive the collection bag.

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