Stoma plug and stoma cover systems

Abstract

Stoma cover or stoma plug systems for covering and / or plugging stoma are provided according to various embodiments. The stoma cover systems and stoma plug systems can be used by ostomates as a temporary means to stop or contain stoma effluent, for example, when changing ostomy pouch systems or showering.

Description

STOMA PLUG AND STOMA COVER SYSTEMSBACKGROUND

[0001] The present subject matter relates to devices and systems for covering or plugging stoma.

[0002] Ostomy pouching systems can include an adhesive barrier and a waste collection bag that attach to the person’s abdomen to enclose the stoma. The ostomy pouching systems can be used to manage stoma discharge, allowing an ostomate to live a life of quality and dignity. However, there are times when managing discharge can be challenging, for example, when the stoma discharge is active while a user needs to change or remove the ostomy pouching system. In such instances, it can be difficult to properly clean the peristomal skin and oftentimes users are forced to rush through the cleaning and changing process to reduce the risk of accidents. Improper cleaning and / or prolonged exposure to dejecta (also referred to herein as “stoma discharge”) can result in peristomal skin complications and damaged skin barriers.

[0003] Further, it is desirable to provide means to enable individuals with stomas to shower comfortably without the constraint of an ostomy bag. It is also desirable to provide systems and devices that a user can use while cleaning the peristomal skin in a sanitary and satisfactory manner. The present disclosure provides systems for covering and / or plugging stoma that can be used by users during changing ostomy pouching systems or showering or when users need a temporary means to stop stoma effluent according to various embodiments.SUMMARY

[0004] Systems for covering and / or plugging stoma are provided according to various embodiments.

[0005] In one aspect, a stoma plug appliance may include a cap assembly and an absorbent rod. The cap assembly may include a cap and a clip, and the absorbent rod may be attached to the cap assembly via the clip. The absorbent rod may be configured for insertion into a stoma. The cap assembly may be configured for secure attachment of the absorbent rod during use and easy detachment of the absorbent rod after use. The cap may be formed from a silicone material.The absorbent rod may be provided as a disposable component that can be discarded after use and replaced with a new absorbent rod.

[0006] In an embodiment, the clip may be attached to an inner surface of the cap, such that the handle portions of the clip define protruding top portions of the cap assembly. In such an embodiment, the stoma plug appliance may be configured to attach the absorbent rod to the cap assembly by a user squeezing the protruding top portions to open the clip and grabbing the absorbent rod and detach the absorbent rod by squeezing the protruding top portions to open the clip to release the absorbent rod.

[0007] In an embodiment, the cap assembly may be configured such that the clip is arranged within an inner space of the cap and a lower periphery of the clip is arranged spaced away from a lower periphery of the cap. In some embodiments, the cap may include a gas outlet and a filter attached to a surface of the cap to cover the gas outlet to allow gas collected in the cap assembly to egress.

[0008] In an embodiment, the absorbent rod may include a rod and an absorbent material. The absorbent rod may be formed by wrapping the absorbent material around the rod. The absorbent material may be formed from an absorbent polyurethane foam or a super absorbent hydrophilic foam. The rod may be formed from polylactic acid. In some embodiments, the absorbent rod may include a water-soluble outer layer configured to facilitate smooth insertion of the absorbent rod into the stoma.

[0009] In an embodiment, the rod may include a head configured to engage with the clip to secure the absorbent rod to the cap assembly. In such an embodiment, the stoma plug appliance may be configured to attach the absorbent rod to the cap assembly by the clip grabbing the head of the rod.

[0010] In another aspect, a stoma appliance may comprise a stomal seal, an inner shell, an outer shell and a cap including an attachment disk. The stoma seal may be configured to seal against a stoma and include a flow path defined therein. The stoma seal may be formed from a silicone material. The inner shell may include a cavity defined therein and may be configured to be in a fluid communication with the stoma seal and removably attached to the stoma seal. The inner shell may be filled with loose sodium polyacrylate configured to thicken stoma effluent.The outer shell may be configured to connect the inner shell to the cap. The outer shell may include a lower opening configured to receive the inner shell and threads in an upper portion configured to engage with thread provided in the cap. The stoma appliance may be configured to attach to a user’s skin via the attachment disk.

[0011] In an embodiment, the inner shell may be provided as a disposable component and configured to be detached from the rest of the stoma appliance and replaced with a new inner shell after use. In some embodiments, the inner shell may include a plurality of indents configured to facilitate grip of the inner shell by a user for easy removal of the inner shell from the outer shell.

[0012] In an embodiment, the cap may include a leg integrally formed with the cap and extending from a periphery of the cap. The leg may include a coupling member configured to engage and secure the attachment disk to the leg. The leg may be configured such that the attachment disk can be attached to user’s skin at a distance away from the stoma to avoid a peristomal skin area immediately surrounding the stoma. In some embodiments, the attachment disk may be formed from a silicone material and include an adhesive for attachment to the user’s skin.

[0013] In one aspect, a stoma cover system may comprise a base including a first magnetic ring and a cover including a second magnetic ring. The base may be configured to attach to user’s peristomal skin and include a flange formed from a silicone material. The flange may include a stoma sleeve configured to grip the stoma. The stoma cover system may be configured to hold the cover in place by the magnetic force between the first and second magnetic rings.

[0014] In another aspect, a stoma cover system may comprise a cover including an aperture lens and a belt. The cover may be configured to cover the stoma, and the aperture lens may be configured to open and close by a rotating motion. The belt may be configured to secure the cover to a user, wherein the cover is attached to the belt.

[0015] In yet another aspect, a stoma cover system may comprise a tube configured to cover a stoma and contain stoma effluent and a plurality of legs extending from the tube. The plurality of legs may be configured to attach to a user’s skin to secure the tube to the user.

[0016] In an embodiment, the plurality of legs may be configured to reach out past a peristomal skin area immediately surrounding the stoma. Each of the plurality of legs may be provided with an adhesive on a body-side surface for attachment to the user’s skin.

[0017] In one aspect, a stoma cover may be formed from a silicone material and configured to cover a stoma and create a vacuum around the stoma.

[0018] In another aspect, a stoma cover may be formed from a shrink wrap material and configured to shrink and mold over a stoma upon exposure to heat to cover and seal the stoma.

[0019] In yet another aspect, a stoma cover system may comprise a cover configured to cover a stoma and an attachment bandage for attaching the cover to a user. The attachment bandage may comprise an adhesive layer, a backing layer and an absorbent layer. The attachment bandage may be configured to wrap around a perimeter of the stoma with the absorbent layer facing toward the stoma and attach to itself via the adhesive layer.

[0020] In one aspect, a stoma cover system may comprise an internal plug configured for insertion into a stoma and create a seal.

[0021] In another aspect, a stoma cover system may comprise a base and an internal plug attached to the base. The internal plug may be formed from a rubber sleeve and configured to be inserted into a stoma and become inflated in the stoma to create a seal.

[0022] In yet another embodiment, a stoma dejecta capturing device may comprise a catch box and a belt attached to the catch box. The belt may be configured to be worn by a user such that the catch box is arranged under user’s stoma to capture stoma dejecta.

[0023] In one aspect, a stoma device may comprise an elastic ring and a chute extending from the elastic ring and arranged to cup a bottom portion of user’s stoma to direct stoma effluent. The chute may include a curved lip extending past the stoma.

[0024] Other aspects and advantages will become apparent upon consideration of the following detailed description and the attached drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0025] FIG. 1 is a perspective view of a stoma plug comprising a cap, a clip and an absorbent rod according to an embodiment;

[0026] FIG. 1A is a side view of the cap with the clip of FIG. 1 shown without the absorbent rod;

[0027] FIG. IB is a top view of the cap of FIG. 1A;

[0028] FIG. 1C is a perspective view of the clip of FIG. 1;

[0029] FIG. ID is a perspective view of a rod component of the absorbent rod of FIG. 1 ;

[0030] FIG. IE is a perspective view of the absorbent rod of FIG. 1;

[0031] FIG. 2 is a perspective view of the stoma plug of FIG. 1 attached to a user;

[0032] FIG. 3 is a side view of a stoma appliance according to an embodiment;

[0033] FIG. 4 is a cross-sectional view of the stoma appliance of FIG. 3 taken along the lineA-A;

[0034] FIG. 5 is a top view of the stoma appliance of FIG. 3; and

[0035] FIG. 6 is an exploded view of the stoma appliance of FIG. 3;

[0036] FIG. 7A is a perspective view of a stoma cover system including a base and a cover according to an embodiment;

[0037] FIG. 7B is a perspective view of the stoma cover system of FIG. 7A, wherein the cover is engaged with the base;

[0038] FIG. 7C is a cross-sectional view of the stoma cover system of FIG. 7B;

[0039] FIG. 7D is a top view of the base of the stoma cover system of FIG. 7A;

[0040] FIG. 7E is a cross-sectional view of the base of FIG. 7D;

[0041] FIG. 7F is a bottom view of the cover of the stoma cover system of FIG. 7A;

[0042] FIG. 7G is a cross-sectional view of the cover of FIG. 7F;

[0043] FIG. 8A is a perspective view of a stoma cover system including a belt and an aperture lens according to an embodiment;

[0044] FIG. 8B is a perspective view of the stoma cover system of FIG. 8A with the aperture lens closed;

[0045] FIG. 8C is a perspective view of the stoma cover system of FIG. 8 A with the aperture lens open;

[0046] FIG. 9 is a perspective view of a belt for a stoma cover and / or a stoma effluent capturing device according to an embodiment;

[0047] FIGS. 10A and 10B are illustrations of a one-piece silicone stoma cap according to an embodiment;

[0048] FIG. 11 A is a perspective view of a silicone stoma cap according to an embodiment;

[0049] FIG. 1 IB is a cross-sectional view of the silicone stoma cap of FIG. 11A;

[0050] FIG. 11C is a bottom view of the silicone stoma cap of FIG. 11 A;

[0051] FIGS. 12A and 12B are illustrations of a stoma cover system including a stoma tube and attachment points according to an embodiment;

[0052] FIG. 13 is a cross-sectional view of a stoma cover system including a suction cup attachment according to an embodiment;

[0053] FIG. 14 is an illustration of a shrink wrap like stoma cover according to an embodiment;

[0054] FIG. 15 is a perspective view of a zip tie device for attachment of a stoma cover according to an embodiment;

[0055] FIG. 16A is a cross-sectional view of an attachment bandage for attachment of a stoma cover according to an embodiment;

[0056] FIG. 16B is a perspective view of the attachment bandage of FIG. 16A attached around the stoma according to an embodiment;

[0057] FIG. 17 is a perspective view of a stoma cover system including an internal plug according to an embodiment;

[0058] FIG. 18A is a perspective view of a stoma cover system including an internal balloon according to an embodiment;

[0059] FIG. 18B is a perspective view of the stoma cover system of FIG. 18A with the internal balloon inflated according to an embodiment;

[0060] FIG. 19 is an illustration of a stoma dejecta capturing device including a catch box according to an embodiment;

[0061] FIG. 20 is an illustration of a stoma device including a chute according to an embodiment;

[0062] FIG. 21 is an illustration of a stoma dejecta capturing device including a balloon according to an embodiment; and

[0063] FIG. 22 is an illustration of a stoma dejecta capturing device including a tube according to an embodiment.DETAILED DESCRIPTION

[0064] Stoma plug and / or stoma cover systems are provided according to various embodiments.

[0065] Stoma Plug Appliance

[0066] Referring to FIGS. 1-2, a stoma plug appliance 10 comprising a cap 12, a clip 14 and an absorbent rod 16 is shown according to an embodiment. The stoma plug appliance 10 may be configured to temporarily occlude a stoma and prevent leakage during short-term activities where conventional ostomy pouches may be unsuitable. The stoma plug appliance 10 may generally comprise two main components: a cap assembly 11 (Fig. 1 A) and the absorbent rod 16 (FIG. IE).

[0067] The cap assembly 1 1 may comprise the cap 12 and the clip 14. As shown in FIGS. 1 and 1A, the clip 14 may be attached to an inner surface of the cap 12, such that handle portions 24 of the clip 14 may define protruding portions 15 of the cap assembly 11. The cap assembly 11 may be configured such that the clip is arranged within an inner space of the cap 12 and a lower periphery 26 of the clip 14 is arranged a spaced apart from a lower periphery 28 of the cap12 (FIG. 1 A). In an embodiment, the cap 12 may be formed from a silicone material, such as a medical-grade silicone. In some embodiments, the cap assembly 11 may include a gas outlet formed in the cap 12 and a fdter, such as a charcoal filter, attached to an inner surface of the cap 12 covering to the gas outlet to allow gases collected in the cap assembly 11 to egress.

[0068] The cap assembly 11 may be configured for secure attachment of the absorbent rod 16 during use and for easy detachment of the absorbent rod 16 after use. When the absorbent rod 16 is attached to the cap assembly 11 via the clip 14, the cap assembly 11 may facilitate insertion and removal of the absorbent rod 16 into and from the stoma, while reducing the risk of contamination. In the embodiment of FIGS. 1-2, a user may attach the absorbent rod 16 to the cap assembly 11 by squeezing the protruding top portions 15 to open the clip 14 and grabbing the absorbent rod 16. After use, the user may dispose the used absorbent rod 16 by squeezing the protruding top portions 15 to open the clip 14 without directly contacting the used absorbent rod 16.

[0069] The absorbent rod 16 may comprise a rod 18 (FIG. ID) and an absorbent material 20. In an embodiment, the absorbent rod 16 may be constructed by wrapping a sheet of the absorbent material 20 around the rod 18. The rod 18 may be relatively rigid to support the structural integrity of the absorbent rod 16 during use. In an embodiment, the rod 18 may be formed from polylactic acid (PLA). The rod 18 may include a head 22 configured to engage with the clip 14 to secure the absorbent rod 16 to the cap assembly 11. As shown in FIG. 1 , the absorbent rod 16 may be attached to the cap assembly 11 via the clip 14 grabbing the head 22 of the rod 18.Suitable materials for the absorbent material 20 may include absorbent foams, such as absorbent polyurethane foams (e.g. absorbent polyurethane foam marketed under the tradename CuraFoam™ dressing and available from Dynarex) and super absorbent hydrophilic foam. In some embodiments, the absorbent rod 16 may include a water-soluble outer layer. For example, the absorbent rod 16 may be coated with a thin, water-soluble polyethylene glycol (PEG) layer configured to facilitate smooth insertion of the absorbent rod 16 into the stoma.

[0070] The absorbent rod 16 may be configured as a disposable component that can be discarded after use and replaced with a new absorbent rod 16. In such embodiments, the absorbent rod 16 may be releasably connected to the cap assembly 11 for easy attachment and detachment from the cap assembly 11. The absorbent rod 16 may be configured for insertioninto the stoma, while the cap 12 covers the stoma externally. The absorbent rod 16 may be removed and discarded after use, and the cap assembly 11 may be reused with a new absorbent rod 16.

[0071] In an embodiment, the absorbent rod 16 may be configured to have a length L of about 40 mm to about 80 mm, preferably about 60 mm, and a thickness T of about 10 mm to about 20 mm, preferably about 15 mm. In such an embodiment, the rod 18 may be configured to have a length Lrof about 40 mm to about 80 mm, preferably about 60 mm. In some embodiments, the absorbent rod 16 may have a greater thickness T (wider) at the top (proximate the head 22) to prevent the absorbent rod 16 from slipping into the stoma. The rod 18 may include the head 22 having a generally square shape with each side S measuring about 5 mm to about 9 mm, preferably about 7 mm, and a thickness t of about 0.7 mm to about 1.3 mm, preferably about 1 mm. The clip 14 may comprise a plurality of teeth 30 configured to securely grab the head 22, wherein each of the plurality of teeth 30 may be spaced apart from an adjacent tooth by a gap G of about 0.7 mm to about 1.3 mm, preferably about 1 mm such that the head 22 may fit between the adjacent teeth 30. The cap 12 may be configured to have a diameter D of about 40 mm to about 80 mm, preferably about 60 mm, and a height H of about 20 mm to about 60 mm, preferably about 40 mm. The cap 12 may be formed from silicone and configured to provide a sealed interface over the stoma without the use of adhesives.

[0072] The stoma plug appliance 10 may be configured to have a low-profile and lightweight. In an embodiment, the stoma plug appliance 10 may be configured to have a weight of about 30 grams (g) to about 50 g, preferably about 38 g, which can provide an 86% reduction in weight compared to conventional ostomy pouches. In some embodiments, the cap 12 may be provided in various colors to match different skin tones and / or further customized for user preference. The stoma plug appliance 10 can offer a discreet, skin-friendly alternative for ostomy patients during activities such as exercise or intimacy, where minimal interference, improved comfort, and aesthetic considerations are desired.

[0073] Superabsorbent Foam Plug

[0074] In an embodiment a superabsorbent stomal plug is provided. The superabsorbent stoma plug may be configured to be breathable and lightweight and to provide ostomates’ peristomal skin a break from an adhesive. The stoma plug may be configured to be easy toremove from the stoma after use and to minimize contact with the ostomate’s skin. The stoma plug may comprise a super absorbable hydrophilic foam core encased in a water-soluble liner and may include a silicone cap and a filter, such as a charcoal filter. The stoma plug may be configured to have a shape similar to a tampon with the silicone cap attached to a flat top portion (the top portion opposite a lower portion that is inserted into the stoma). The stoma plug may be configured such that the top portion protrudes out from the stoma after the stoma plug is inserted into the stoma. The water-soluble liner may be configured to hold the foam core in the original shape and allow for easy insertion into the stoma. The stoma plug may be configured to expand after being inserted into the stoma and reduce the risk of the stoma plug slipping all the way into the stoma. The stoma plug may include a filter attached to the hollow side (inner surface) of the silicone cap to allow gases that are trapped in the foam core or the stoma plug to pass therethrough to reduce the accumulation of interstomal pressure. The stoma plug may include a string, such as a cotton string, stitched into the foam core that can serve as a means for removing the stoma plug from the stoma. The stoma plug can be provided as a completely disposable device.

[0075] Absorbent Stoma Cap

[0076] In an embodiment, an absorbent stoma cap may be configured for attachment to user’s peristomal skin via an adhesive and to cover the stoma. In this embodiment, the stoma cap may be configured as a fully external absorption device free of a plug that is inserted into the stoma, which may be preferable to some ostomates. The absorbent stoma cap may be configured to have a cylindrical shape having a diameter of about 65 mm and rounded top edges. The absorbent stoma cap may have an area carved out in the middle.

[0077] Two Piece Stoma Cap with Locking Mechanism

[0078] In an embodiment, a two-piece stoma cap system may generally comprise a cap for covering the stoma and a baseplate including a locking mechanism. The stoma cap system may be configured as a lightweight device that can provide discretion. The stoma cap system may be worn when an ostomate expects to have a low effluent output such as after irrigation. The cap may be configured as a generally circular patch that covers the stoma. The baseplate may be formed from a polymeric material(s), such as polyethylene and polypropylene that can provide areliable seal and secure connection in the locking mechanism to a cap attachment. The locking mechanism may be configured to provide easy placement and removal of the cap.

[0079] Wicking Stoma Plug

[0080] In an embodiment, a temporary stoma plug that can last for a brief time (about 30-45 minutes) is provided. The stoma plug may be configured to function as a pump to transfer effluent from the stoma to an absorbent portion of the stoma plug. The stoma plug may be configured to operate based on the pressure difference between a higher pressure in the inner stoma environment and a lower pressure in an empty tube leading to the absorbent portion. In some embodiments, the stoma plug may have a rounded mushroom head shape. The stoma plug may be configured to manage an active stoma while having intimate moments, while minimizing uncomfortable friction due to the rounded mushroom head shape design.

[0081] Stoma Appliance

[0082] Referring to FIGS. 3-6, a stoma appliance 100 according to an embodiment is shown. The stoma appliance 100 may generally comprise a stoma seal 102, an inner shell 104, an outer shell 106, a cap 108 and an attachment disk 110.

[0083] The stoma seal 102 may be configured to seal against the stoma and prevent leakage between the stoma and the inner shell 104. The stoma seal 102 may include a flow path 103 defined therein to allow stoma effluent (also referred to herein as stoma dejecta) to flow through the stoma seal 102 and into the inner shell 104. The stoma seal 102 may be formed from a soft silicone material.

[0084] The inner shell 104 may be configured to be in a fluid communication with the stoma seal 102 and include a cavity 105 defined therein for receiving stoma effluent. The inner shell 104 may contain absorbent material and / or materials configured to thicken stoma effluent. In an embodiment, the inner shell 104 may be filled with loose sodium polyacrylate configured to thicken the stoma effluent to minimize the risk of leakage. The inner shell 104 may be provided as a disposable component that can be detached from the rest of the stoma appliance 100 and replaced with a new inner shell 104. In some embodiments, the inner shell 104 may include indents 112 configured to facilitate grip of the inner shell 104 by a user for easy removal fromthe outer shell 106. In the embodiment of FIGS. 3-6, the inner shell 104 may include two indents 112.

[0085] The outer shell 106 may be configured to connect the inner shell 104 to the cap 108. In an embodiment, the outer shell 106 may include a lower opening 114 configured to receive the inner shell 104 and threads 116 in an upper portion.

[0086] The cap 108 may include threads 118 configured to engage with the outer shell threads 116 to allow the cap 108 to screw on and off from the outer shell 106. The cap 108 may be configured to anchor the stoma appliance 100 to user’s skin via the attachment disk 110. The cap 108 may include a leg 120 which may be integrally formed with the cap 108 and extending from a periphery of the cap 108. The leg 120 may include a coupling member 122 configured to engage and secure the attachment disk 110. The attachment disk 110 may be formed from a silicone material and include an adhesive for attachment to user’s skin. In an embodiment, the attachment disk 110 may be coated with a silicone adhesive on a body-side surface.

[0087] In an embodiment, the leg 120 may be configured such that the attachment disk 110 can be attached to user’s skin a distance away from the stoma to avoid the area of user’s peristomal skin that is typically exposed to skin barrier adhesives for using ostomy pouch systems. For example, the attachment disk 110 may be attached to user’s skin above the stoma beyond the user’s peristomal skin that has been exposed to the skin barrier adhesives. In an embodiment, the leg 120 may be configured to extend beyond a 5 inches x 5 inches peristomal skin area surrounding the stoma to minimize further irritation or damage of the peristomal skin from using the attachment disk 110. For example, the leg 120 may have a length of about 5 inches to about 10 inches. In some embodiments, the cap 108 may include belt tabs 124 for further support and attachment of the stoma appliance 100 using a belt (not shown).

[0088] Stoma Cover System with Magnetic Rings

[0089] Referring to FIGS. 7A-7G, a stoma cover system 200 according to an embodiment is shown. The stoma cover system 200 may generally comprise a base 202 including a first magnetic ring 204 and a cover 206 including a second magnetic ring 208. The base 202 may comprise a flange 210 formed from a silicone material and including a stoma sleeve configured to grip the stoma 201 through friction and slight suction. The stoma cover system 200 may beconfigured to hold the cover 206 in place by the magnetic force between the first and second magnet rings 204, 208, while allowing easy removal. The base 202 formed from a silicone material and including the magnetic ring 204 may be configured to provide liquid tight seal against user’s peristomal skin and provide water-resistant stoma cover system when engaged with the cover 206. In case of waste (stoma effluent) output, a user can simply remove the cover 206 and free the stoma. The base 202 formed from a silicone material may be configured to provide the elastic properties sufficient to fit over various size stomas while protecting the tissue from circulation cutoff. In some embodiments, the stoma cover system 200 may be configured such that the base 202 may be used with different covers including a magnetic ring to provide users flexibility to select a cover according to various situations. The stoma cover system 200 may be configured to be reused and easily cleaned.

[0090] Stoma Cover System with Aperture Lens Cover

[0091] Referring to FIGS. 8A-8C, a stoma cover system 300 is shown according to an embodiment. The stoma cover system 300 may generally comprise a cover 302 attached to a belt 304. The cover 302 may include an aperture lens 306 that is configured to operate similar to the camera lens aperture technology. The cover 302 may be configured such that the cover 302 may open and close by a rotating motion. In the embodiment of FIGS. 8A-8C, the cover 302 may be configured to open by rotating the cover in a counterclockwise direction CC and close by rotating in a clockwise direction C. The cover 302 may be configured to allow a user to wash the stoma during shower while providing a quick means to cover the stoma by closing the aperture lens 306 in case the stoma suddenly becomes active during the shower. The closing and opening of the cover 302 may be configured to be purely mechanical for safe to operation in the shower.

[0092] The cover 302 may be attached to user’s body via the belt 304. The belt 304 may be an adjustable belt that can wrap around the user. In such an embodiment, the stoma cover system 300 may be an adhesive-free system that does not require an adhesive to attach a stoma cover to a user. The belt 304 may be made of a soft and water-resistant material that can be comfortable to wear. The belt 304 may be configured to provide adjustability that can fit a wide range of users. The belt 304 may be configured to allow user’s peristomal skin to breathe without adhesive and can be moved slightly during the shower to wash underneath it.

[0093] FIG. 9 shows a waterproof belt 304’ according to an embodiment. The belt 304’ may be configured to attach around a user’s waist. The belt 304’ may include a ring 310 configured for attachment on user’s peristomal skin around the stoma. The ring 310 may be configured such that a stoma effluent capturing device or a stoma cover may be attached to the user via the ring 310.

[0094] Silicone Stoma Cap

[0095] Referring to FIGS. 10A and 10B, a stoma cap 400 according to an embodiment is shown. The stoma cap 400 may be formed from a silicone material and configured to cover the stoma 402 and stick to the surrounding peristomal skin through friction and body heat. The silicone stoma cap 400 may be configured to stick to user’s skin and stay on in water, making the device suitable for showering. The silicone stoma cap 400 may be configured as single-piece device that fits snugly over the stoma and temporarily contains stomal effluent. The silicone stoma cap 400 may be easily washed and reused. The stoma cap 400 may be configured to fit a wide range of stomas and bodies.

[0096] FIGS. 11 A-C show a silicone stoma cap 500 according to another embodiment. In an embodiment, the silicone stoma cap 500 may be configured to have a height H of about 0.5 inches to about 1 inch and an inner diameter ID of about 0.75 inches to about 1.5 inches. For example, the silicone stoma cap 500 may have a height H of about 0.75 inches and an inner diameter ID of about 1.1 inches.

[0097] Stoma Cover System including Tube with Attachment Points

[0098] Referring to FIGS. 12A and 12B, a stoma cover system 600 according to an embodiment is shown. The stoma cover system 600 may generally comprise a tube 602 and a plurality of legs 604. The tube 602 may be configured to cover the stoma 601 and contain stoma effluent for a short period. The plurality of legs 604 may extend from the tube and configured for attachment to various areas of user’s skin around the stoma. The stoma cover system 600 may be configured to allow for hands-free use and to work effectively in various occasions, such as in shower. The stoma cover system 600 may be configured such that the plurality of legs can reach out past the peristomal skin area immediately surrounding the stoma. As such, traditional skin adhesive methods may be used to attach the legs to user’s skin without further irritating ordamaging the peristomal skin. In some embodiments, each of the plurality of legs 604 may be include a skin adhesive arranged on a body-side surface 606 for attachment to user’s skin. For example, the plurality of legs 604 may be provided with a simple, waterproof skin adhesive. The location of the attachment sites may be alternated to minimize the risk of the skin getting irritated from frequent use of the stoma cover system.

[0099] Devices and methods for anchoring stoma cover to user’s abdomen

[0100] Devices and methods to anchor a stoma cover or stoma cap to user’s abdomen are provided according to various embodiments. The attachment devices and methods may be configured to attach a stoma cover or stoma cap to user’s body while minimizing pressure applied to the stoma.

[0101] In an embodiment, a stoma cover may be attached to user’s skin via a suction cup like attachment method. FIG. 13 is a cross-sectional view of a stoma cover 700 configured for a suction cup like attachment. The stoma cover 700 may be configured to create a vacuum around the stoma 701 by gripping on the peristomal skin 702. In the embodiment of FIG. 13, the stoma cover 700 may include a suction cupping section 704, a first inner space 706 defined therein configured to surround the stoma 701, and a second inner space 708 defined therein configured as a reservoir for stoma effluent. The stoma cover 700 may be formed from medical grade silicone for skin-friendly application and to create a secure, leak proof grip around the stoma without adhesives.

[0102] In another embodiment, a stoma cover may be attached to a user’s skin via a shrink wrap like attachment method. FIG. 14 is an illustration of a stoma cover 800 configured for a shrink wrap like attachment. The stoma cover 800 may be formed from a shrink wrap material and configured to provide a water-tight seal. The stoma cover 800 may be configured to thermoform over the stoma with the application of heat. As illustrated in FIG. 14, the stoma cover 800 may be configured to shrink and mold around the stoma 801 to create a secure seal. In an embodiment, the stoma cover 800 may be configured to be activated and shrink when heat is applied using, for example, a blow dryer 803 at low temperatures for ease of use.

[0103] In an embodiment, a stoma cover may be attached to user’s skin via a hook and loop fastener (e.g. Velcro). In such an embodiment, a stoma cover system may include a stoma capand a base plate, which may be configured for easy attachment and detachment from each other. The stoma cover system may not require adhesives.

[0104] In another embodiment, a stoma cover or a stoma cap may be attached to a user via a zip tie. FIG. 15 shows a zip tie attachment device 900 according to an embodiment. The zip tie attachment device may feature a flexible, toothed strap that is threated through a locking head. Inside the head, a one-way ratchet mechanism may engage with the teeth of the strap, ensuring a secure hold as the strap tightens. A spring loaded release button 902 may be provided to allow the ratchet mechanism to disengage.

[0105] In an embodiment, a stoma cover or a stoma cap may be attached to a user via an attachment bandage. FIG. 16A shows a cross-sectional view of an attachment bandage 1000 according to an embodiment. The attachment bandage 1000 may generally comprise an adhesive layer 1002, a backing layer 1004, and an absorbent layer 1006. The attachment bandage 1000 may be configured to wrap around the perimeter of the stoma 1001 with the absorbent layer 1006 facing toward the stoma 1001 as shown in FIG. 16B. The attachment bandage 1000 may be configured to attach to itself via the adhesive layer 1002 and may be flexible to minimize pressure on the stoma.

[0106] Referring to FIG. 17, a stoma cover system 1100 include an internal plug 1102 is shown according to an embodiment. The stoma cover system 1100 may include a malleable plug 1102 that can be placed inside the stoma to create a secure seal (similar to a pacifier). The tip of the plug 1102 may be enlarged to anchor the plug 1102 in place during use. The compression of the stoma on the plug 1102 may hold the plug 1102 in place during use.

[0107] Referring to FIGS 18A and 18B, a stoma cover system 1200 including an internal balloon 1202 is shown according to an embodiment. In this embodiment, the internal balloon 1202 may be formed from a rubber sleeve and attached to base of the stoma cover system 1200. The internal balloon 1202 may be inserted into the stoma 1201 and can be inflated to create a seal internal to the stoma as shown in FIG. 18B. The internal balloon 1202 can be inflated with a balloon pump.

[0108] Referring to FIG. 19, a stoma dejecta capturing device 1300 comprising a catch box 1302 according to an embodiment is shown. The catch box 1302 may be attached to a belt 1304that is positioned under the stoma 1301 to collect effluent drainage of the stoma 1301 . The catch box 1302 may be supported by the belt 1304 and can be adjusted utilizing the belt loops.

[0109] Referring to FIG. 20, a stoma device 1400 comprising a chute or funnel 1402 according to an embodiment is shown. The stoma device 1400 may include an elastic ring 1404 with a molded silicone chute 1402 at the base. The stoma device 1400 may be configured to attach to user’s peristomal skin, such that the chute 1402 may cup the bottom of the stoma 1402 to direct stoma effluent off peristomal skin as it drains. The chute 1402 may be curved with a lip 1406 that extends past the base of the stoma to collect drainage and reduce contact of the stoma with peristomal skin.

[0110] In some embodiments, the stoma dejecta capturing device may include an external balloon as shown in FIGS. 21 and 22. In the embodiment of FIG. 21, a stoma dejecta capturing device 1500 may include a flexible rubber balloon 1502 and configured to attach around the stoma 1501. The balloon 1502 may be inflated and filled with gas and stoma effluent draining from the stoma 1501.

[0111] In the embodiment of FIG. 22, a stoma dejecta capturing device 1600 may include a tube 1602. The tube 1602 may stretch and utilize gravity to move the stoma effluent away from the user’s stoma 1601. The distal end 1604 of the tube 1602 may be attached to a capturing box or a bag to drain larger volumes of stoma effluent.

[0112] While particular embodiments of the present invention have been illustrated and described, it would be apparent to those skilled in the art that various other changes and modifications can be made and are intended to fall within the spirit and scope of the present disclosure. Furthermore, although the present disclosure has been described herein in the context of a particular implementation in a particular environment for a particular purpose, those of ordinary skill in the art will recognize that its usefulness is not limited thereto and that the present disclosure may be beneficially implemented in any number of environments for any number of purposes. Accordingly, the claims set forth below should be construed in view of the full breadth and spirit of the present disclosure as described herein.

[0113] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

[0114] The use of the terms “a” and “an” and “the” and similar references in the context of describing the embodiments disclosed herein (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate the disclosure, and does not pose a limitation on the scope of the disclosure unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the disclosure.

[0115] Numerous modifications to the present disclosure will be apparent to those skilled in the art in view of the foregoing description. It should be understood that the illustrated embodiments are exemplary only and should not be taken as limiting the scope of the disclosure.

Claims

I / WE CLAIM:

1. A stoma plug appliance, comprising: a cap assembly including a cap and a clip; an absorbent rod configured for insertion into a stoma; and wherein the absorbent rod is attached to the cap assembly via the clip.

2. The stoma plug appliance of claim 1, wherein the clip is attached to an inner surface of the cap, such that the handle portions of the clip define protruding top portions of the cap assembly.

3. The stoma plug appliance of claim 1 or 2, wherein the cap assembly is configured for secure attachment of the absorbent rod during use and easy detachment of the absorbent rod after use.

4. The stoma plug appliance of claim 2, wherein the stoma plug appliance is configured to attach the absorbent rod to the cap assembly by a user squeezing the protruding top portions to open the clip and grabbing the absorbent rod, and detach the absorbent rod by squeezing the protruding top portions to open the clip to release the absorbent rod.

5. The stoma plug appliance of any one of claims 1-4, wherein the cap assembly is configured such that the clip is arranged within an inner space of the cap and a lower periphery of the clip is arranged spaced away from a lower periphery of the cap.

6. The stoma plug appliance of any one of claims 1-5, wherein the cap includes a gas outlet and a filter attached to a surface of the cap to cover the gas outlet to allow gas collected in the cap assembly to egress.

7. The stoma plug appliance of any one of claims 1-6, wherein the absorbent rod includes a rod and an absorbent material, wherein the absorbent rod is formed by wrapping the absorbent material around the rod.

8. The stoma plug appliance of claim 1, wherein the rod includes a head configured to engage with the clip to secure the absorbent rod to the cap assembly.

9. The stoma plug appliance of claim 8, wherein the stoma plug appliance is configured to attach the absorbent rod to the cap assembly by the clip grabbing the head of the rod.

10. The stoma plug appliance of any one of claims 7-9, wherein the rod is formed from polylactic acid.

11. The stoma plug appliance of any one of claims 7-10, wherein the absorbent material is formed from an absorbent polyurethane foam or a super absorbent hydrophilic foam.

12. The stoma plug appliance of any one of claims 1-11, wherein the absorbent rod includes a water-soluble outer layer configured to facilitate smooth insertion of the absorbent rod into the stoma.

13. The stoma plug appliance of any one of claims 1-12, wherein the cap is formed from a silicone material.

14. The stoma plug appliance of any one of claims 1-13, wherein the absorbent rod is provided as a disposable component that is discarded after use and replaced with a new absorbent rod.

15. A stoma appliance, comprising: a stoma seal configured to seal against a stoma including a flow path defined therein; an inner shell removably attached to the stoma seal and in a fluid communication with the stoma seal, the inner shell including a cavity defined therein; a cap including an attachment disk; and an outer shell configured to connect the inner shell to the cap; wherein the stoma appliance is configured to attach to a user’s skin via the attachment disk.

16. The stoma appliance of claim 15, wherein the inner shell is filled with loose sodium polyacrylate configured to thicken stoma effluent.

17. The stoma appliance of any one of claims 15-16, wherein the inner shell is provided as a disposable component, wherein the inner shell is configured to be detached from the rest of the stoma appliance and replaced with a new inner shell after use.

18. The stoma appliance of any one of claims 15-17, wherein the inner shell includes a plurality of indents configured to facilitate grip of the inner shell by a user for easy removal of the inner shell from the outer shell.

19. The stoma appliance of any one of claims 15-18, wherein the outer shell includes a lower opening configured to receive the inner shell and threads in an upper portion configured to engage with thread provided in the cap.

20. The stoma appliance of any one of claims 15-19, wherein the cap include a leg integrally formed with the cap and extending from a periphery of the cap, wherein the leg includes a coupling member configured to engage and secure the attachment disk to the leg.

21. The stoma appliance of claim 20, wherein the leg is configured such that the attachment disk can be attached to the user’s skin a distance away from the stoma to avoid a peristomal skin area immediately surrounding the stoma.

22. The stoma appliance of any one of claims 15-21, wherein the attachment disk is formed from a silicone material and includes an adhesive for attachment to the user’s skin.

23. The stoma appliance of any one of claims 15-22, wherein the stoma seal is formed from a silicone material.

24. A stoma cover system, comprising;a base configured to attach to user’s peristomal skin, the base including a flange formed from a silicone material and a first magnetic ring, wherein the flange includes a stoma sleeve configured to grip a stoma; and a cover including a second magnetic ring; wherein the stoma cover system is configured to hold the cover in place by magnetic force between the first and second magnetic rings.

25. A stoma cover system, comprising; a cover configured to cover a stoma and including an aperture lens, wherein the aperture lens is configured to open and close by a rotating motion; and a belt configured to secure the cover to a user, wherein the cover is attached to the belt.

26. A stoma cover system, comprising; a tube configured to cover a stoma and contain stoma effluent; and a plurality of legs extending from the tube and configured to attach to a user’s skin to secure the tube to the user.

27. The stoma cover system of claim 26, wherein the plurality of legs are configured to reach out past a peristomal skin area immediately surrounding the stoma.

28. The stoma cover system of claim 26 or 27, wherein each of the plurality of legs is provided with an adhesive on a body-side surface for attachment to the user’s skin.

29. A stoma cover formed from a silicone material and configured to cover a stoma, wherein the stoma cover is configured to create a vacuum around the stoma.

30. A stoma cover formed from a shrink wrap material, wherein the stoma cover is configured to shrink and mold over a stoma upon exposure to heat to cover and seal the stoma.

31. A stoma cover system, comprising; a cover configured to cover a stoma; and- l-an attachment bandage for attaching the cover to a user, the attachment bandage comprising: an adhesive layer; a backing layer; and an absorbent layer; wherein the attachment bandage is configured to wrap around a perimeter of the stoma with the absorbent layer facing toward the stoma and attach to itself via the adhesive layer.

32. A stoma cover system comprising an internal plug, wherein the internal plug is configured for insertion into a stoma and create a seal.

33. A stoma cover system, comprising; a base; and an internal plug attached to the base and formed from a rubber sleeve; wherein the internal plug is configured for insertion into a stoma, wherein the internal plug is configured to be inflated in the stoma to create a seal.

34. A stoma dejecta capturing device, comprising; a catch box; and a belt attached to the catch box; wherein the belt is configured to be worn by a user such that the catch box is arranged under user’s stoma to capture stoma dejecta.

35. A stoma device, comprising; an elastic ring; and a chute extending from the elastic ring and arranged to cup a bottom portion of user’s stoma to direct stoma effluent, wherein the chute includes a curved lip extending past the stoma.

36. A stoma dejecta capturing device comprising an external balloon configured to cover user’s stoma, wherein the external balloon is configured to contain stoma effluent and inflate.

37. A stoma dejecta capturing device, comprising; a tube configured to cover user’s stoma and include a flow path defined therein; and a catch box, wherein a distal end of the tube is connected to the catch box, wherein the tube is configured to direct stoma effluent from the stoma to the catch box.

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