Stoma appliance with gate valve

Abstract

Stoma appliances with gate valves, anchoring-sealing stem balloons and waste collection bag systems and methods of use are disclosed.

Description

STOMA APPLIANCE WITH GATE VALVERELATED APPLICATION DATA

[0001] This application claims the benefit of priority of U.S. Provisional Patent Application Serial No. 63 / 541,054, filed September 28, 2023, and titled “Stoma Appliance with Gate Valve”, which is incorporated by reference herein in its entirety.FIELD OF THE DISCLOSURE

[0002] The present disclosure generally relates to the field of osteotomy appliances. In particular, the present disclosure is directed to a stoma appliance with gate valve.BACKGROUND

[0003] Surgical procedures often require post-operative access to a patient’s body cavity to drain fluids or waste that may cause infection. A “stoma” is an example of one such type of surgically created access. In one common application a stoma is an opening to allow waste from the patient’s intestines to exit the body following colostomy or ileostomy surgery. When a stoma is surgically formed for a patient, the patient’s intestine is passed through an opening that is created in the abdominal wall. The opening goes through several layers of tissue that help to hold the stoma in place. These layers include skin, fat, fascia, and muscle. The skin and fat layers are relatively compliant and the fascia and muscle layers relatively stiff.

[0004] Waste exiting through the stoma is collected in a device, like a bag or pouch, that attaches around the stoma or connects to the stoma via a drain tube. This conventional arrangement, while effective to allow drainage, typically affords the patient little control of waste as it drains involuntarily into a collection device attached to the drain tube. Patients may elect to occlude the drain passage with, for example, a plug (in the stoma) or clamp (on the drain tube), however, discomfort may result because the stoma is not meant to tolerate occlusion for long periods of time. Damage to the drain tube may also allow waste to leak before the collection device.

[0005] The present Applicant has previously disclosed improvements to conventional stoma appliances, for example in U.S. Patent No. 11771585 and PCT Publication No. WO2023 / 069659.

[0006] The present disclosure describes further improvements to such stoma appliances.SUMMARY

[0007] In one implementation, the present disclosure is directed to a stoma valve appliance that includes a base having an outer side and an inner skin-facing side configured to be secured to a patient over a stoma, the base defining a flow path through the base between having an inner opening on the inner side of the base and an outer opening on the outer side of the base; a gate valve disposed in the base slidable between an open position and a closed position to control flow through the flow path; a stem with an inlet at a distal end and an outlet at a proximal end projecting inwardly from the base configured to be received in the patient stoma, the stem proximal end communicating with the inner opening of the base to continue the flow path through the stem; a balloon formed around the stem; a balloon inflation port disposed on the outer side of the base; and a balloon inflation lumen extending from the balloon inflation port through the base and along the stem opening in the balloon.

[0008] In another implementation, the present disclosure is directed to a stoma closure system, that includes a base having an outer side and an inner skin-facing side configured to be secured to a patient over a stoma, the base defining a flow path through the base between having an inner opening on the inner side of the base and an outer opening on the outer side of the base and plural attachment tabs disposed around the outer opening; a gate valve disposed in the base slidable between an open position and a closed position to control flow through the flow path; a stem with an inlet at a distal end and an outlet at a proximal end projecting inwardly from the base configured to be received in the patient stoma, the stem proximal end communicating with the inner opening of the base to continue the flow path through the stem; a balloon formed around the stem positioned on the stem and configured to secure the valve appliance in and seal the stoma; a balloon inflation port disposed on the outer side of the base; and a balloon inflation lumen extending from the balloon inflation port through the base and along the stem opening in the balloon; an adhesive wafer removably securable to the inner side of the base, the adhesive wafer having a central opening sized to allow a protruding portion of the stoma to extend therethrough; a waste bag plate defining bag plate opening configured with a sealing surface to provide a removable sealed connection with the outer opening of the base, the waste bag plate further comprising: plural bag clips arranged around the bag plate opening configured to engagebehind the attachment tabs on the outer surface of the base, and oppositely extending arms configured for holding and manipulating the bag plate, whereby rotation of the bag plate when placed in contact with the base removably attaches the bag plate to the base, the bag clips and corresponding attachment tabs being spaced apart to allow operation of the gate valve; and a waste pouch attached to the bag plate around the bag plate opening on an opposite side of the bag plate from the sealing surface.

[0009] In yet another implementation, the present disclosure is directed to a method of attaching a waste bag to a stoma valve appliance and evacuating waste from the stoma. The method includes placing an inlet opening of the waste bag in sealing engagement with an outlet of the stoma valve appliance; positioning the waste bag with waste bag attachment clips adjacent to attachment tabs on the stoma valve appliance; and rotating the waste bag to engage the attachment clips behind the attachment tabs.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] For the purpose of illustrating the disclosure, the drawings show aspects of one or more embodiments of the disclosure. However, it should be understood that the present disclosure is not limited to the precise arrangements and instrumentalities shown in the drawings, wherein:FIG. 1A depicts a top view of an exemplary embodiment of a valve appliance in a closed position;FIG. IB depicts a cross-section of the valve appliance shown in FIG. 1 A through line A-A with a patient attachment wafer;FIG. 2A depicts a top view of the valve appliance shown in FIG. 1 A with the gate valve in an open configuration;FIG. 2B depicts a side view of the valve appliance shown in FIG. 2A.FIG. 3 depicts a perspective view of the valve appliance shown in FIG. 2A combined with an effluent capture device;FIG. 4 depicts a perspective view of an effluent capture device for use with the valve appliance;FIG. 5 A depicts a front view of a bag plate from the effluent capture device shown in FIG. 4;FIG. 5B depicts a cross-section of the bag plate shown in FIG. 5A through Line B-B; andFIG. 6 depicts a perspective view of an embodiment of a valve appliance with the gate valve in an open configuration.

[0011] Where applicable, like-reference characters designate identical or corresponding components and units throughout the several views (which are not to scale unless otherwise indicated). The embodiments disclosed herein may include elements that appear in one or more of the several views or in combinations of the several views. Methods are exemplary only and may be modified by, for example, reordering, adding, removing, and / or altering the individual stages.DETAILED DESCRIPTION

[0012] The discussion that follows describes medical appliances that can engage with surgically-formed stoma on a patient. These appliances allow patients to periodically discharge waste from their bodies into a bag, tube, other container, or directly into a toilet for proper disposal . The designs proposed allow the patient to control flow in a convenient manner while remaining properly engaged with the stoma to minimize leaks or other inadvertent discharge of waste.

[0013] FIGS. 1A and IB illustrate an exemplary embodiment of a valve appliance 500 configured to interface with a patient’s stoma to allow patient-controlled elimination of waste through the stoma. The valve appliance 500 is comprised of a base 502 that is configured in some embodiments to be attached to an adhesive wafer 100 with an adhesive material on skin facing surface 102 by a deformable base clip 503 that engages with a deformable wafer clip 104 that allows for ease of changing the adhesive wafer by a snap-fit type connection. Adhesive wafer 100 has an opening 106 to allow the stem of the base portion to pass therethrough. The opening may be centrally located in adhesive wafer 100 to provide an annular wafer configuration that allows the stoma or portion of the stoma to protrude through the central opening of the adhesive wafer. Base 502 is shaped to provide a domed cavity 508. The opening 106 and domed cavity 508 are configured to cover the patient’s stoma that often protrudes from the surface of the patient’s skin without compressing or otherwise impacting or irritating the stoma. It will be noted by persons of skill in the art that the snap-fit connection clip configuration shown in FIG. IB is not the onlypossible configuration for conveniently and removably connecting the base and adhesive wafer. Other suitable attachment configurations include interlocking threads allowing the base 502 and adhesive wafer 100 to be screwed together and screwed apart. In a further alternative, a detent, latch, compression washer, or other restraining device could be used alone or in combination with a threaded connection to prevent the threads from separating unless intended.

[0014] The base 502 engages a gate valve 504 positioned at the front of the base 502. The gate valve 504 has valve handle tabs 505a and 505b on one end to enable the patient to open and close the gate valve 504 as will be described later herein. The gate valve 504 is constrained within a slot 506 (see FIG. 2A) in the top of the base 502 by a valve cover 507. The valve cover 507 and base 502 constrain the gate valve 504 but allow the gate valve 504 to slide open and closed as will be described further herein. The valve cover 507 has one or more bag clip engagement tabs 517a, 517b, 517c, and 517d. The bag clip engagement tabs 517a, 517b, 517c, and 517d are configured to hold a bag clip as further described hereinbelow. The valve cover 507 includes an exit nozzle 526 that guides effluent away from the valve appliance 500. The exit nozzle 526 can be covered by a nozzle cap (not shown) when the patient is not operating the valve appliance 500 to remove effluent. The base 502 includes a fill port 570 that includes a luer attachment 571. The fill port 570 and luer attachment 571 are configured to engage a syringe (not shown) that is used to fill an anchor balloon 590 (shown on FIG. IB) as will be described further herein.

[0015] FIG. IB shows fill port 570 that forms a fill lumen 572 that is connected to the balloon lumen 573. The balloon lumen 573 connects to the inside of a balloon 590. The balloon 590 is located around a stem 516 near the entry port 530. By connecting a syringe filled with either a gas or liquid to the fill port 570, the gas or liquid can be directed through the fill lumen 572 and the balloon lumen 573 into the balloon 590 to increase the diameter of the balloon 590 as shown in FIG. 2B. In this manner the balloon 590 can be used after the valve appliance 500 has been placed inside the patient’s stoma to seal against the inside of the patient’s stoma to ensure that effluent is directed into the entry port 530 and through the drain passage 528 past the open gate valve 504 and out the exit port 532, and the inflated balloon 590 prevents effluent from leaking around the stem 516 when the valve appliance 500 is positioned in the patient’s stoma. The gas and / or liquid can be contained in the balloon 590 by including a pinching valve (not shown) inside the balloon lumen 573 that is held open by connecting the syringe to the luer attachment 571 (shown on FIG.1 A) and which closes when the syringe is removed. Any other method of containing the air or liquid in the balloon can also be employed including but not limited to the inclusion of a stop cock valve, ball valve, and any other type of valve in the balloon lumen 573. In addition to sealing against the inside of the patient’s stoma, if the stem 516 of the valve appliance 500 is inserted to a sufficient depth into the patient’s stoma, the balloon 590 can also anchor the valve appliance 500 to the inside surface of the fascia and / or the muscle layers of the patient’s abdomen. In this manner the balloon 590 can provide both a mechanical anchor against the inside wall of the fascia and a sealing function against the inside diameter of the stoma (intestine, ileal / colonic conduit, etc.) for the valve appliance 500. The balloon 590 pressing on the inside surface of the fascia and / or muscle layers can provide an additional sealing function.

[0016] FIG. IB also shows a top o-ring 521 positioned between the gate valve 504 and the valve cover 507 and a bottom o-ring 522 positioned between the gate valve 504 and the base 502. The top o-ring 521 and the bottom o-ring 522 ensure that effluent does not leak from the inside of the stem 516 around the gate valve 504 when the gate valve is closed. The top o-ring 521 and the bottom o-ring 522 also ensure that the effluent passes through the gate valve 504 and out the exit port 532 when the gate valve 504 is opened and ensure that the effluent does not pass between the base 502 and the gate valve 504 nor between the gate valve 504 and the valve cover 507. Alternative seal designs in addition to a standard o-ring shape can also be used to ensure the proper functioning of the valve appliance 500.

[0017] To open the valve appliance 500, the patient grasps the valve handles 505a and 505b, pinches them towards each other, and pulls the gate valve 504 to the open position as shown in FIG. 2A. The gate valve 504 is configured with a gate opening that aligns with the drain passage 528 in the stem 516 and the exit port 532 when the gate valve 504 is in the open position to allow effluent to drain. As shown in FIG. 2A, the gate valve 504 is also configured with one or more stop ledges 561 that engage with one or more complementarily shaped stop pocket 510 formed in the side of the receiving slot 506 to hold the gate valve 504 in the closed position. Pinching the valve handles 505a and 505b towards each other will disengage the stop ledge 561 from the stop pocket and allow the gate valve 504 to be slid into the open position. Flex slot 512 is provided between handles 505a and 505b to facilitate movement of stop ledge 561 into and out of stop pocket 510. While a single stop ledge / stop pocket combination is shown in FIG. 2A, it will beappreciated by those skilled in the art that one or more such combinations may be added, for example one on each side of the gate valve.

[0018] One method of removing effluent with the valve appliance 500 is by attaching an effluent capture device 580 (also referred to as a waste bag) as shown in FIG. 3. Note that in the illustrated embodiment, pouch 582 of effluent capture device 580 is made from a transparent material and thus does not obscure components of the valve appliance 500 or bag plate 584. In other embodiments, non-transparent materials may be selected. The pouch 582 may be secured to bag plate 584 by conventional means such as adhesives or plastic welds. To attach the effluent capture device 580 to base 502, one or more bag clips 586a, 586b, 586c, and 586d on the bag plate 584 of the effluent capture device 580 are engaged with the one or more bag clip attachment tabs 517a, 517b, 517c, and 517d (shown on FIG. 1A) on the base 502 of the valve appliance 500. The one or more bag clips 586a, 586b, 586c, and 586d can be engaged with the one or more bag clip attachment tabs 517a, 517b, 517c, and 517d by screwing together, snapping together or by any other commonly used actuation method. The patient can use one or more bag plate arms 588a and 588b to hold the bag 580 to engage with the valve appliance 500. The bag plate arms 588a and 588b are configured with one or more tactile elements 589 that provide better gripping for the patient to engage the bag 580 with the valve appliance 500. The one or more tactile elements 589 can be an opening in the bag plate arms 588a and 588b as shown in FIG. 3. Alternatively, the one or more tactile elements can be impressions, projections, or any combination of openings, impressions, or projections that create a better gripping surface. After the effluent capture device 580 is attached to the valve appliance 500, the patient can open the valve gate 504 to allow effluent to empty into a pouch 582 of the effluent capture device 580. After the effluent has been emptied, the gate valve 504 can be closed and the effluent capture device 580 can be disengaged from the valve appliance 500.

[0019] As shown in FIGS. 4, 5A and 5B, the bag plate 584 includes an opening 583 that allows effluent to flow from the exit port 532 of the valve appliance 500 into the effluent capture device 580. The opening 583 is defined on the outside by a sealing surface 585. This sealing surface 585 creates a seal with the exit port 532 to ensure the effluent flows from the valve appliance 500 into the effluent capture device 580 without leaking. The sealing surface 585 can be made from any of a number of soft compliant materials such as but not limited to silicone, latex,natural rubber, butyl rubber, Nitrile, Neoprene, and the like. Alternatively, the sealing surface 585 can be made from a rigid plastic and the exit port 532 surface can be made of a soft compliant surface to also achieve a seal between the exit port 532 and the sealing surface 585.

[0020] As shown in FIG. 5B, the bag plate 584 includes a projecting surface 587 opposite the sealing surface 585. The projecting surface 587 faces the inside of waste pouch 582 to ensure that the effluent has a clear path into the pouch 582 of the effluent capture device 580. The projecting surface 587 reduces the likelihood of the pouch 582 being closed or obstructed by forcing one inside surface of the pouch 582 away from the other inside surface of the pouch 582.

[0021] An alternative embodiment of the valve appliance 600 with distal balloon 690 and proximal balloon 692 on the stem 616 is shown in FIG. 6. Valve appliance 600 includes base 602, gate valve 604, valve handles 605a and 605b, bag clip attachment tabs 617a-d and exit port 632. Having a distal balloon 690 and proximal balloon 692 can provide additional sealing between the stem 616 and the inside of the stoma. It also can provide additional anchoring of the valve appliance 600 to the patient. For example, the distal balloon 690 can anchor against the inside surface of the fascia and / or muscle layer while the proximal balloon 692 anchors against the outside layer of the fascia and / or muscle layer. This anchoring around the inside and outside layer of the fascia and / or muscle layer by the distal balloon 690 and proximal balloon 692 also provide additional sealing to ensure that effluent does not leak around the valve appliance 600. In some embodiments, the distal balloon may be larger in diameter than the proximal balloon to provide further anchoring and sealing security. The distal balloon 690 and proximal balloon 692 can be fdled with either a gas or liquid by using the fill port 670. They can be filled simultaneously or alternatively; a three-way valve can be included with the fill port 670 such that one balloon can first be filled with the three-way valve in a first position, then the three-way valve actuated to a second position to fill the second balloon and then the three-way valve can be actuated again to the third position to confine the air and / or liquid in both balloons. After the desired use of the valve appliance 500 or 600, the syringe can be reattached to the luer attachment 571 or 671 to remove the gas or liquid from the balloons 590, 690, 692 so that the valve appliance 500, 600 can be easily removed from the stoma.

[0022] The foregoing has been a detailed description of illustrative embodiments of the disclosure. It is noted that in the present specification and claims appended hereto, conjunctive language such as is used in the phrases “at least one of X, Y and Z” and “one or more of X, Y, and Z,” unless specifically stated or indicated otherwise, shall be taken to mean that each item in the conjunctive list can be present in any number exclusive of every other item in the list or in any number in combination with any or all other item(s) in the conjunctive list, each of which may also be present in any number. Applying this general rule, the conjunctive phrases in the foregoing examples in which the conjunctive list consists of X, Y, and Z shall each encompass: one or more of X; one or more of Y; one or more of Z; one or more of X and one or more of Y; one or more of Y and one or more of Z; one or more of X and one or more of Z; and one or more of X, one or more of Y and one or more of Z.

[0023] Various modifications and additions can be made without departing from the spirit and scope of this disclosure. Features of each of the various embodiments described above may be combined with features of other described embodiments as appropriate in order to provide a multiplicity of feature combinations in associated new embodiments. Furthermore, while the foregoing describes a number of separate embodiments, what has been described herein is merely illustrative of the application of the principles of the present disclosure. Additionally, although particular methods herein may be illustrated and / or described as being performed in a specific order, the ordering is highly variable within ordinary skill to achieve aspects of the present disclosure. Accordingly, this description is meant to be taken only by way of example, and not to otherwise limit the scope of this disclosure.

[0024] Exemplary embodiments have been disclosed above and illustrated in the accompanying drawings. It will be understood by those skilled in the art that various changes, omissions and additions may be made to that which is specifically disclosed herein without departing from the spirit and scope of the present disclosure.

Claims

What is claimed is:

1. A stoma valve appliance, comprising: a base having an outer side and an inner skin-facing side configured to be secured to a patient over a stoma, the base defining a flow path between having an inner opening on the inner side of the base and an outer opening on the outer side of the base; a gate valve slidable between an open position and a closed position to control flow through said flow path; a stem with an inlet at a distal end and an outlet at a proximal end projecting inwardly from the base configured to be received in the patient stoma, the stem proximal end communicating with the inner opening of the base to continue said flow path through the stem; a balloon disposed around the stem; a balloon inflation port disposed on the outer side of the base; and a balloon inflation lumen extending from the balloon inflation port through the base and along the stem opening in the balloon.

2. The stoma valve appliance of claim 1, wherein the balloon is configured to secure the valve appliance in and seal the stoma.

3. The stoma valve appliance of claim 1 or claim 2, wherein the balloon is disposed at the distal end of the stem.

4. The stoma valve appliance of claim 3, further comprising a second balloon disposed around the stem between the distal and proximal ends of the stem.

5. The stoma valve appliance of claim 4, wherein a first balloon at the stem distal end is configured primarily for anchoring the valve appliance in the stoma and the second balloon between the distal and proximal ends is configured primarily for sealing the stoma against leaks.

6. The stoma valve appliance of claim 4 or claim 5, wherein said inflation port and inflation lumen communicate with the first and second balloons.

7. The stoma valve appliance of claim 4 or claim 5, wherein said inflation port and said inflation lumen communicate with said first balloon and said valve appliance further comprises a second inflation port and a second inflation lumen communicating with the second balloon.

8. The stoma valve appliance of any preceding claim further comprising a valve disposed in the inflation port for sealing the inflation port and inflation lumen.

9. The stoma valve appliance of any preceding claim, wherein the gate valve slides in a slot formed in the base.

10. The stoma valve appliance of claim 9, wherein the gate valve has a deflectable side protrusion configured to be received in a pocket in a side of said slot to secure the gate valve in a closed position.

11. The stoma valve appliance of claim 10, wherein the gate valve has a handle portion with at least one resilient arm configured to bias the side protrusion into said pocket.

12. The stoma valve appliance of claim 11, wherein the at least one resilient arm of the handle portion includes at least one user manipulable tab to permit disengagement of the side protrusion from said pocket.

13. The stoma valve appliance of any of claims 9-12, further comprising a valve cover on the base over said slot to retain the gate valve in the slot.

14. The stoma valve appliance of any preceding claim, further comprising a patient attachment wafer removably securable to the inner side of the base.

15. The stoma valve appliance of claim 14, wherein the patient attachment wafer has a central opening sized to allow a protruding portion of the stoma to extend therethrough.

16. The stoma valve appliance of claim 14 or claim 15, wherein the patient attachment wafer is secured to the base by mating clips on the base and said wafer, at least one said clip being deformable to provide a snap-fit connection between the base and patent attachment wafer.

17. The stoma valve appliance of any of claims 14-16, wherein the stem has a length sufficient to extend through the patient attachment wafer to position the distal end of the stem within the stoma when the base is secured to the patient attachment wafer and attached to the patient.

18. The stoma valve appliance of any of claims 14-17, wherein the patient attachment has a skin facing surface comprising an adhesive material selected for attachment of the stoma valve appliance to the patient over the stoma.

19. The stoma valve appliance of any preceding claim, further comprising an effluent capture device configured to attach to the base, the effluent capture device comprising a pouch attached to a bag plate, wherein the bag plate defines an opening configured with a sealing surface to provide a sealed connection with the outer opening of the base.

20. The stoma valve appliance of claim 19, wherein the bag plate comprises: plural bag clips arranged around the bag plate opening configured to engage behind corresponding attachment tabs on the outer surface of the base whereby rotation of the bag plate when placed in contact with the base removably attaches the effluent capture device to the base, said bag clips and corresponding attachment tabs being spaced apart to allow operation of the gate valve; and oppositely extending arms configured for holding and manipulating the effluent capture device.

21. The stoma valve appliance of claim 20, wherein each said arm of the bag plate includes one or more tactile elements to facilitate patient manipulation of the effluent capture device.

22. The stoma valve appliance of any of claims 19-21, wherein the bag plate further comprises a projection around an upper portion of the bag plate opening projecting into the waste pouch to prevent obstruction of the bag plate opening by material of the waste pouch.

23. The stoma valve appliance of any preceding claim, wherein balloon inflation port comprises a luer-lock fitting.

24. A stoma closure system, comprising: a base having an outer side and an inner skin-facing side configured to be secured to a patient over a stoma, the base defining a flow path through the base between having an inner opening on the inner side of the base and an outer opening on the outer side of the base and plural attachment tabs disposed around said outer opening; a gate valve slidable between an open position and a closed position to control flow through said flow path; a stem with an inlet at a distal end and an outlet at a proximal end projecting inwardly from the base configured to be received in the patient stoma, the stem proximal end communicating with the inner opening of the base to continue said flow path through the stem;a balloon disposed around the stem configured to secure the valve appliance in and seal the stoma; a balloon inflation port disposed on the outer side of the base; and a balloon inflation lumen extending from the balloon inflation port through the base and along the stem opening in the balloon; an adhesive wafer removably securable to the inner side of the base, the adhesive wafer having a central opening sized to allow a protruding portion of the stoma to extend therethrough; a waste bag plate defining bag plate opening configured with a sealing surface to provide a removable sealed connection with the outer opening of the base, the waste bag plate further comprising: plural bag clips arranged around the bag plate opening configured to engage behind said attachment tabs on the outer surface of the base, and oppositely extending arms configured for holding and manipulating the bag plate, whereby rotation of the bag plate when placed in contact with the base removably attaches the bag plate to the base, said bag clips and corresponding attachment tabs being spaced apart to allow operation of the gate valve; and a waste pouch attached to the bag plate around the bag plate opening on an opposite side of the bag plate from the sealing surface.

25. The stoma closure system of claim 24, wherein said balloon comprises a first balloon and a second balloon.

26. The stoma closure system of claim 25, wherein: the first balloon is disposed at the stem distal end and configured primarily for anchoring the valve appliance in the stoma; and the second balloon is disposed between the distal and proximal ends and configured primarily for sealing the stoma against leaks.

27. The stoma closure system of any of claims 24-26, further comprising a valve disposed in the inflation port for sealing the inflation port and inflation lumen.

28. The stoma closure system of any of claims 24-27, wherein: the gate valve slides in a slot formed in the base;the gate valve has a deflectable side protrusion configured to be received in a pocket in a side of said slot to secure the gate valve in a closed position; and the gate valve has a handle portion with at least one resilient arm configured to bias the side protrusion into said pocket.

29. The stoma closure system of claim 28, wherein the at least one resilient arm of the handle portion of the gate valve includes at least one user manipulable tab to permit disengagement of the side protrusion from said pocket.

30. The stoma closure system of any of claims 24-29, wherein the oppositely extending arms of the bag plate each include one or more tactile elements to facilitate patient manipulation of the waste bag plate.

31. A method of attaching an effluent capture device to a stoma valve appliance, comprising: placing an inlet opening of the effluent capture device in sealing engagement with an outlet of the stoma valve appliance; positioning the effluent capture device with waste bag attachment clips adjacent to attachment tabs on the stoma valve appliance; and rotating the effluent capture device to engage the attachment clips behind the attachment tabs.

32. The method of claim 31 , further comprising opening a valve on the stoma valve appliance after attaching the effluent capture device and while the effluent capture device remains attached to the stoma valve appliance.

33. The method of claim 32, further comprising closing the valve while the effluent capture device remains attached to the stoma valve appliance.

34. The method of claim 33, further comprising, after closing the valve, rotating the effluent capture device to disengage the effluent capture device from the stoma valve appliance.

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