DEVICES, SYSTEMS AND METHODS FOR CONTROLLING FLOW FROM A STOMAS IN A PATIENT - Patent application

Abstract

The medical device is composed of a material that forms a fluid barrier with the inner wall of the patient's stoma. These configurations can include an annular disk with a stem on one side that is inserted into the stoma. The material may be present on the stem, for example in the form of a replaceable hollow tube that covers at least a portion of the stem. On the other hand, a rotatable spigot is inserted into the notch. The rotatable spigot has a first position that forms a flow path through the stem and the annular disk to allow waste to exit the stoma. In one embodiment, the rotatable spigot can be coupled to a collector that receives the waste. The patient can return the rotatable spigot to a second position to block the flow of waste.

Description

[Technical field]

[0001] Related Application Data This application claims priority to U.S. Provisional Patent Application No. 63 / 270,808, entitled "Devices, Systems and Methods for Controlling Flow From a Stoma in a Patient," filed on October 22, 2021. This application also claims priority to U.S. Nonprovisional Patent Application No. 17 / 846,863, filed on June 22, 2022. These two co-pending patent applications are incorporated by reference in their entireties herein.

[0002] The present disclosure relates generally to the field of osteotomy instruments. In particular, the present disclosure relates to devices, systems and methods for controlling flow from a stoma in a patient. [Background technology]

[0003] After surgery, patients often require access to their body cavity to drain fluids or waste that may cause infection. A "stoma" is one example of one such type of surgically created access. In one common application, a stoma is an opening that allows waste from a patient's intestine to exit the body after a colostomy or ileostomy. The waste collects in a return passage or pouch-like device that is attached around the stoma or connected to the stoma via an excretory tube. This conventional configuration is effective in allowing drainage, but the patient has little control over the waste, as it typically drains involuntarily into a collector that is attached to the excretory tube. Patients may choose to block the drainage passage with, for example, a plug (in the stoma) or a clamp (on the excretory tube), but this can cause discomfort because stomas are not intended to tolerate blockage for long periods of time. Also, damage to the excretory tube can allow waste to leak out in front of the collector. Summary of the Invention [Means for solving the problem]

[0004] In one embodiment, the present disclosure is directed to a stoma valve device. The stoma valve device includes an annular support member, a base member, a valve, a stem, and a gas permeable filter seal. The annular support member is configured to surround a stoma of a patient and has an interior side, a skin facing side, and an exterior side. The base member is removably attachable to a center of the annular support member. The base member defines a first solid-liquid flow path and a second gas vent flow path through the base member. Each flow path has at least one opening on the interior side of the base member. The valve is disposed on the base member. The base member is configured to control flow in the first flow path. The valve has an open position that allows flow and a closed position that blocks flow. The valve is operable by the patient between the open and closed positions. The stem has an inlet and an outlet that protrude inwardly from a body member that is configured to be received in the stoma of the patient. The stem has a length sufficient to extend through the center of the annular support member to position the inlet within the stoma when the base member is mounted on the annular support member and the outlet at the opposite end communicates with the opening of the first flow path in the base member. A gas permeable filter seal seals around the stem covering the opening of at least one second gas vent flow path, thereby allowing gas from the stoma to be vented through the second flow path while preventing liquids and solids from entering the second flow path.

[0005] In another embodiment, the present disclosure is directed to a patient-controllable method for evacuating waste from a stoma, the method including placing a venting valve device at the stoma having a closed position that prevents waste from evacuating from the stoma and an open position that allows waste to evacuate from the stoma, the patient selectively moving the valve device between the open and closed positions to evacuate waste from the stoma or to retain waste within the stoma for later evacuation, and continuously venting gas from the stoma through the valve device in both the open and closed positions.

[0006] In yet another embodiment, the present disclosure is directed to a stoma valve device. The stoma valve device includes an annular support member, a skin adhesive layer, a base member, a valve, and an outlet nozzle. The annular support member is configured to surround a patient's stoma. The annular support member has an inner side, a skin-facing side, and an outer side. The skin adhesive layer is disposed on the inner, skin-facing side of the annular support member. The base member is removably attachable to a center of the annular support member. The base member defines a flow path through the base member. The flow path has an opening on the inner side of the base member. The valve is disposed on the base member configured to control flow through the flow path. The valve has an open position that allows flow and a closed position that blocks flow. The valve is operable by the patient between the open and closed positions. The outlet nozzle terminates a first pathway through the base member opposite the inner opening that accepts flow through the valve in the open position. [Brief description of the drawings]

[0007] For the purpose of illustrating the present disclosure, the drawings show aspects of one or more embodiments of the present disclosure, it being understood, however, that the present disclosure is not limited to the precise arrangements and instrumentalities shown in the drawings.

[0008] [Figure 1] 1 is a schematic diagram of an exemplary embodiment of a valve device in place on a patient. [Figure 2A] FIG. 1 is a perspective view of an embodiment of a valve device. [Figure 2B] FIG. 2B is a front view of the embodiment of the valve device shown in FIG. 2A. [Figure 2C] FIG. 2C is a cross-sectional view of the embodiment of the valve device shown in FIG. 2B taken along line AA. [Figure 3A] FIG. 2B is an exploded perspective view of the embodiment of the valve device shown in FIG. 2A. [Figure 3B] 3B is an exploded cross-sectional view taken along line AA (shown in FIG. 2B) of the embodiment of the valve device shown in FIG. 3A. [Figure 4A] FIG. 2B is a front view of some of the components of the embodiment of the valve device shown in FIG. 2A in a closed configuration. [Figure 4B]2B is a front view of some of the components of the embodiment of the valve device shown in FIG. 2A in an open configuration. [Diagram 5] 4B is a cross-sectional view of some of the components of the embodiment of the valve device of FIG. 2A in the open configuration, FIG. 4B. [Figure 6A] 2B is a front perspective view of a waste capture device for use with the embodiment of the valve device shown in FIG. 2A. [Figure 6B] FIG. 6B is a rear perspective view of the waste capture device shown in FIG. 6A. [Figure 7] 6B is a perspective view of the waste capture device shown in FIG. 6A combined with the valve device embodiment shown in FIG. 2A. [Figure 8] 6B is a perspective view of some of the components of the waste capture device shown in FIG. 6A combined with some of the components of the valve apparatus embodiment shown in FIG. 2A. [Figure 9A] FIG. 13 is a perspective view of another embodiment of a valve device. [Figure 9B] FIG. 9B is a front view of the embodiment of the valve device shown in FIG. 9A. [Figure 9C] FIG. 9C is a cross-sectional view of the embodiment of the valve device shown in FIG. 9B. [Figure 9D] FIG. 9C is a cross-sectional view of a valve device as shown in FIGS. 9A and 9B having an alternative filter seal configuration. [Figure 9E] FIG. 9B is a cross-sectional view of an alternative valve device similar to the embodiment shown in FIG. 9A, but without a stem or gas vent passage. [Figure 10A] FIG. 9B is a front view of some of the components of the embodiment of the valve device shown in FIG. 9A in a closed configuration. [Figure 10B] FIG. 9B is a front view of some of the components of the embodiment of the valve device shown in FIG. 9A in an open configuration. [Figure 11A] FIG. 13 is a rear view of an alternative waste capture device clip. [Figure 11B] FIG. 11B is a side view of the alternative waste capture device clip shown in FIG. [Figure 12]FIG. 11A is a perspective view of the valve device shown in FIG. 9A combined with the alternative waste capture device clip shown in FIGS. 11A-B. [Figure 13A] FIG. 13 is a perspective view of yet another embodiment of a valve device. [Figure 13B] FIG. 13B is a front view of the embodiment of the valve device shown in FIG. 13A. [Figure 13C] FIG. 13C is a cross-sectional view of the embodiment of the valve device shown in FIG. 13B. [Figure 13D] FIG. 13C is a DD cross-sectional view of the embodiment of the valve device shown in FIG. 13B. [Figure 13E] FIG. 13C is a cross-sectional view of the embodiment of the valve device shown in FIG. 13B taken along an E-E line. [Figure 14A] FIG. 13B is a perspective view of the embodiment of the valve device shown in FIG. 13A in an open configuration. [Figure 14B] FIG. 14B is a front view of the embodiment of the valve device shown in FIG. 14A. [Figure 14C] FIG. 14C is a cross-sectional view of the embodiment of the valve device shown in FIG. 14B.

[0009] Where applicable, like reference numerals designate identical or corresponding components and units throughout the several figures (not to scale unless otherwise indicated). Embodiments disclosed herein may include elements that appear in one or more of the several figures or in combinations of the several figures. The methods are exemplary only and may be modified, for example, by reordering, adding, removing, and / or modifying individual steps. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] The following discussion describes medical devices that can be engaged with a patient's surgically formed stoma. These devices allow the patient to periodically discharge waste from the body into a bag or container for proper disposal. The proposed designs allow the patient to remain properly engaged with the stoma while controlling the flow in a convenient manner to minimize leaks or other inadvertent discharge of waste.

[0011] 1 shows a schematic diagram of an exemplary embodiment of a valve device 100. This embodiment is shown at a location on the patient P where access to a body cavity is required, typically following a surgical procedure. This location may have a stoma or port. The stoma or port allows waste material to exit the patient P and enter a collection device such as a bag or pouch (not shown). The device 100 may include a support unit 102 that receives a spigot 104. A sealing unit 106 may be present in a portion of the support unit 102 to engage the interior of the stoma.

[0012] 2A and 2B show an alternative embodiment of a valve device 200. The valve device 200 is configured to interface with a patient's stoma to allow patient-controlled removal of waste through the stoma. The valve device 200 is comprised of a substrate 202 that is attached to an adhesive wafer 206. The adhesive wafer 206 may be formed as a relatively thin, flexible annular disk. The adhesive wafer 206 is configured to have an adhesive on a back surface 212 to secure the valve device 200 to the patient's skin. For example, an adhesive surface 258 (FIG. 3B) on the adhesive wafer 206 bonds the adhesive wafer 206 to the skin. The adhesive surface 258 may be comprised of any type of skin-compatible adhesive, such as a colloidal hydrogel adhesive. The adhesive wafer 206 may also include a removal tab 219 that is used to assist the patient when the patient desires to remove the adhesive backed wafer from their skin, and a flex joint 203 that allows the adhesive wafer 206 to closely conform to the irregular contours of the patient's skin. The substrate 202 has one or more bag clip engagement slots 213a and 213b and one or more bag clip engagement tabs 217a and 217b. The bag clip engagement slots 213a and 213b and the bag clip engagement tabs 217a and 217b are configured to retain a bag clip, as described further herein. The substrate 202 engages a gate valve 204 located on a front surface of the substrate 202. The gate valve 204 has a valve handle 205 at one end, as described further herein, allowing the patient to open and close the gate valve 204. The gate valve 204 is constrained to the substrate 202 by a valve cover 207. The valve cover 207 and substrate 202 constrain the gate valve 204 but allow the gate valve 204 to slide open and closed, as described further herein. The valve cover 207 includes an outlet nozzle 226 that directs waste away from the valve device 200. When the patient is not manipulating the valve device 200 to remove waste, the outlet nozzle 226 may be covered by a nozzle cap 208. The nozzle cap 208 is connected to the substrate 202 by a tether 211. The tether 211 keeps the nozzle cap 208 connected to the valve device 200 when the patient removes the nozzle cap 208 from the outlet nozzle 226.

[0013] FIG. 2C shows how the substrate 202 is engaged with the adhesive wafer 206 by the substrate clip 241 which engages with the wafer clip 243. The substrate clip 241 of the substrate 202 and the wafer clip 243 of the adhesive wafer 206 allow the two parts to be connected and separated as needed. For example, the patient may want the substrate 202 to be attached to a smaller diameter adhesive wafer 206 that will conform to the skin better than a standard diameter adhesive wafer 206. Similarly, the patient may want the substrate 202 to be attached to an adhesive wafer 206 that has a different type of adhesive that is more compatible with the patient's skin. The compatibility of the adhesive to the patient's skin is a very important characteristic of the valve device 200 because the patient will leave the valve device 200 attached to their skin for more than one day before removing the valve device 200 to replace it with a new one. Additionally, the adhesive wafer 206 includes an annular opening 218 and the substrate 202 includes a dome-shaped cavity 214. The annular opening 218 and domed cavity 214 are configured to cover the patient's stoma, which often protrudes above the surface of the patient's skin, without compressing or otherwise affecting the stoma. By providing a cavity consisting of the annular opening 218 and the domed cavity 214, it is important to accommodate the stoma without irritating the stoma. A patient's stoma can change size and shape over time. Thus, the patient is allowed to exchange the adhesive wafer 206 for different sizes and / or adhesive types. Alternatively, in some embodiments, the adhesive wafer 206 may be configured to allow the patient to trim the annular opening to accommodate the patient's particular stoma size and shape. Similarly, the substrate 202 may be exchanged with other substrates to form a domed cavity 214 that best fits the shape and dimensions of the stoma. Thus, the two-piece configuration disclosed herein provides an additional advantage in patient comfort based on the patient having the ability to control and change the shape and adhesive type over time without having to replace the entire appliance.

[0014] The substrate clips 241 and wafer clips 243 are not the only possible configurations for removably connecting the substrate 202 and adhesive wafer 206. In one alternative, the substrate clips 241 and wafer clips 243 may be replaced with interlocking threads that allow the substrate 202 and adhesive wafer 206 to be screwed together and unscrewed. If threads are used rather than the substrate clips 241 and wafer clips 243, detents, latches, compression washers, or other restraints may be required in addition to the threads to prevent the threads from separating unless intended. An arrangement of interlocking ribs and grooves may also be used, as shown in FIG. 13D and described below. Other removable connectors such as hook-and-loop fasteners and other snap-on or interference fittings may also be used.

[0015] The valve cover 207 is configured with an annular notch 223 configured to hold an annular seal 221. The annular seal 221 is compressed against the valve cover 207 and the valve gate 204 to ensure that waste does not leak between the valve cover 207 and the valve gate 204. The annular seal 221 may be an O-ring type seal. The annular seal 221 may be any other type of seal commonly used to prevent fluid leakage between two components. The annular seal 221 may be glued or otherwise joined to the valve cover 207 rather than compressed against the valve cover 207. The annular seal 221 may also be molded onto the valve cover 207.

[0016] At the rear of the valve device 200 is a stem 216 covered by a gas permeable filter 238. The rear end of the stem 216 has an inlet port 230 that allows waste to enter the exhaust passageway 228. As shown in Figure 2C, the valve 204 is in a closed position, blocking the exhaust passageway 228 and preventing waste that enters the exhaust passageway 228 from exiting the patient's stoma. The gas permeable filter 238 is configured to compress against the inner diameter of the stoma and prevent waste from leaking between the outer surface of the gas permeable filter 238 and the stoma.

[0017] The front of the stem 216 consists of a slot 270 and a protrusion 274, as shown in FIG. 3B. The slot 270 is configured to mate with a shelf 272 of the substrate 202 to connect the stem 216 to the substrate 202. The connection between the slot 270 and the shelf 272 can be a simple overlap connection. The connection can also include an adhesive or similar bond between the slot 270 and the shelf 272. The stem 216 can also be molded into the substrate 202. The protrusion 274 is configured to seal against the back side of the gate valve 204 to prevent waste in the waste passage 228 from leaking around the gate valve 204.

[0018] 3A, the valve cover 207 is shown with a tether slot 253 configured to receive and restrain a tether tab 251 on the end of the tether 211 opposite the nozzle cap 208. The tether slot 253 is shown as part of the valve cover 207, but may be configured as part of the substrate 202. The tether slot 253 and tether tab 251 are just one possible way to restrain the nozzle cap 208 and tether 211 to the remainder of the valve apparatus 200. The tether 211 may be glued or otherwise joined to the valve cover 207 or substrate 202. Also, the tether 211 may be molded into the valve cover 207 or substrate 202.

[0019] The substrate 202 is shown with a substrate opening 231 aligned with the waste passage 228. The substrate opening 231 is also aligned with a valve cover opening 232 present at the forward end of the outlet nozzle 226 of the valve cover 207. The gate valve 204 also has a gate opening 209. The inlet port 230, the waste passage 228, the substrate opening 231 and the valve cover opening 232 are all aligned to allow waste to exit through the valve apparatus 100. However, in the configuration shown in Figures 2A-2 and 3A-3B, the gate opening 209 is not aligned with the inlet port 230, the waste passage 228, the substrate opening 231 and the valve cover opening 232, and the valve apparatus 200 is closed by the gate valve 204.

[0020] Valve cover 207 and nozzle cap 208 have been removed from FIGS. 4A and 4B to facilitate illustration of the operation of opening and closing valve fixture 200. In FIG. 4A, gate valve 204 is in a closed position and substantially aligned with substrate 202. The gate valve is shown with cantilever arms 263a and 263b formed by arm slots 265a and 265b. The ends of cantilever arms 263a and 263b have detents 261a and 261b. Detents 261a and 261b are captured within occlusion pockets 267a and 267b formed in substrate 202. Detents 261a and 261b and occlusion pockets 267a and 267b are configured to constrain gate valve 204 against substrate 202 and prevent gate valve 204 from unintentionally sliding, keeping valve fixture 200 closed. When the patient wishes to open the valve device 200, the patient pulls the valve handle 205 in the direction indicated by the arrow "O" in FIG. 4B. If the pulling force of the detents 261a and 261b against the occlusion pockets 267a and 267b is sufficient, the cantilever arms 263a and 263b will bend into the arm slots 255a and 265b and the detents 261a and 261b will be released from the occlusion pockets 267a and 267b. The gate valve 204 will then slide until the detents 261a and 261b engage the open pockets 269a and 269b formed in the substrate 202. The cantilever arms 263a and 263b will then spring back to hold the detents 261a and 261b in the open pockets 269a and 269b. In this open configuration, the gate opening 209 of the gate valve 204 is aligned with the inlet port 230, the waste passage 228, the substrate opening 231 and the valve cover opening 232. As a result, a complete valve passage 278 exists, as seen in FIG. 5. In this configuration, the valve device 200 is open to allow waste to exit the patient's body. When the patient has finished removing waste, the patient applies force to the valve handle 205 in the direction opposite arrow "O" to slide the gate valve 204 back to the closed position. In this manner, the patient controls the timing of waste being expelled from the body.

[0021] As the waste material exits the valve cover opening 232, it is preferably collected in a waste material bag 280, for example as shown in Figures 6A and 6B. The waste material bag 280 is comprised of a pouch 282 for holding the waste material and a clip 284 for connecting the waste material bag 280 to a valve device, such as the valve device 200. The clip 284 is comprised of one or more hooks 286a and 286b and one or more tabs 287a and 287b, which are configured to hold the waste material bag 280 to the valve device 200. The clip 284 also includes an opening 290 configured to engage with the outlet nozzle 226 to ensure that waste material exiting the outlet nozzle 226 does not leak or spill into the pouch 282. The clip also includes a bag cap 288 connected to the clip by a flexible tether 289. The bladder cap 288 may be used to seal the opening 290 after the waste bag 280 has collected the waste from the valve device 200 and the waste bag 280 has been separated from the valve device 200. The opening 290 may be configured with a seal to seal against the outlet nozzle 226 or against the bladder cap 288 to ensure that waste does not leak at this connection.

[0022] FIG. 7 shows the waste bag 280 attached to the valve device 200. The valve device 200 is now in an open configuration for emptying waste from the patient through the valve device 200 and into the waste bag 280. In FIG. 8, the pouch 282 has been removed from the clip 284 to show details of how the waste bag 280 is connected to the valve device 200. One or more tabs 287a and 287b of the clip 284 are inserted into one or more bag clip engagement slots 213a and 213b of the substrate 202, and one or more hooks 286a and 286b of the clip 284 are snapped onto one or more bag clip engagement tabs 217a and 217b. This secures the clip 284 and waste bag 280 to the valve device 200, and engages the opening 290 of the waste bag 280 with the outlet nozzle 226. In use, the patient first attaches the waste bag 280 to the valve device 200 before opening the gate valve 204 by pulling the valve handle 205. Waste then flows through the open valve device 200 into the waste bag 280. After all waste has been removed through the patient's stoma, the patient presses the valve handle 205 to close the gate valve 204. After the valve device 200 is closed, the patient removes the waste bag 280 from the valve device 200 by removing the clip 284. A bag cap 288 can then be placed on the waste bag opening 290 to prevent waste from leaking. A nozzle cap 208 can also be placed on the outlet nozzle 226 of the valve device 200.

[0023] The substrate 202, gate valve 204, valve cover 207, and bag clip 284 can all be made from a rigid plastic resin. Rigid plastic resins include, but are not limited to, polypropylene, ABS, polycarbonate, and any blends of such materials. These parts can also be made from metals such as aluminum or stainless steel. The substrate portion of the adhesive wafer 206 can be made from a flexible material. Flexible materials include, but are not limited to, silicone, polyurethane foam or film, TPE (thermoplastic elastomer), polyethylene foam or film, PVC foam, nitrile rubber, and any blends of such materials. The adhesive portion of the adhesive wafer 206 can be formed from either an acrylic or synthetic rubber hydrocolloid adhesive, or other adhesive that is skin compatible. The stem 216 can be made from a flexible material, including but not limited to, silicone, polyurethane, TPU, TPE, polyethylene. The stem 216 can be made from a rigid or semi-rigid plastic resin. Rigid or semi-rigid plastic resins include, but are not limited to, polypropylene, ABS, polycarbonate, and any blends of such materials. The gas permeable filter 238 can be made from materials such as, but are not limited to, polyester, rayon, acrylic, polyethylene, polypropylene, cotton, and mixtures thereof. These materials can be hydrophobic or can be treated with a coating such as, but are not limited to, difunctional polysiloxane to achieve hydrophobic performance. The annular seal 216 can be made from flexible or semi-rigid materials. Flexible or semi-rigid materials include, but are not limited to, silicone, polyurethane, TPU, TPE, or other elastic materials. The waste bag 280 can be made from flexible materials such as, but are not limited to, polyethylene, LDPE, HDPE, and other resin films.

[0024] In yet another embodiment, instead of the pouch 282, the flexible excretion tube may be provided with a clip 284 as described above, allowing the patient to direct waste directly into the toilet. In another alternative, the flexible excretion tube may have an outer diameter at one end sized for a slight interference fit with the inner diameter of the outlet nozzle 226. This may allow the excretion tube to be securely inserted into the outlet nozzle 226 when required. Alternatively, the inner diameter of one end of the excretion tube may be sized for a slight interference fit with the outer diameter of the outlet nozzle 226, securing the excretion tube to the outlet nozzle 226 and directing waste into the toilet. This type of flexible excretion tube may be more conveniently carried by the patient in situations where the patient has access to suitable waste disposal facilities.

[0025] The above description of the valve device 200 is not intended to encompass all possible variations of the valve device 200 covered by this disclosure. Referring now to Figures 9A, 9B and 9C, an alternative embodiment of the valve device 300 is shown. The valve device 300 is comprised of a substrate 302, a valve gate 304, a valve cover 307, a seal 321, a stem 316 and a filter plate 340. The substrate 302 includes one or more bag clip engagement tabs 317a and 317b, one or more bag clip pockets 313 and one or more bag clip guides 315a and 315b for engaging waste bag clips 384 as further described herein. The substrate 302 also includes a plurality of vent passages 329 for venting gases through the valve device 300 as further described herein. The valve cover 307 includes an exit port 332 that allows waste to exit the valve device 300. A seal 321 is disposed between the gate valve 304 and the valve cover 307 to ensure that waste does not leak between the gate valve 304 and the valve cover 307 (see FIG. 9C). The stem 316 has an inlet port 330 that allows waste to enter a waste passage 328 that passes through the center of the stem 316. The stem 316 can also seal against the gate valve 304 to ensure that waste does not leak between the stem 316 and the gate valve 304.

[0026] The stem 316 is surrounded by a primary gas permeable filter 338 configured to compress against the inner diameter of the stoma to prevent waste from leaking between the outer surface of the primary gas permeable filter 338 and the stoma. The stem 316 may be surrounded by a secondary gas permeable filter 339 sandwiched between the stem 316 and the primary gas permeable filter 338. The secondary gas permeable filter 339 may be configured to filter more finely than the primary gas permeable filter 338. By providing two or more permeable filters, the valve device 300 can block solid materials and more viscous liquid materials with the primary gas permeable filter 338 and allow gas to pass while blocking all remaining liquids with the secondary gas permeable filter 339. The valve device 300 is not limited to two layers of filters. Any number of filter layers of various filtering capabilities are possible. Having multiple layers of filtration capacity allows liquids and solids to be blocked and gases to pass through without the liquids and solids clogging the first layer of the filter.

[0027] It is important that the valve device 300 allows the passage of gas so that gas does not build up in the patient's digestive tract and cause uncomfortable pressure and sensations. The ability of the valve device 300 to continuously release gas while retaining liquids and solids until the patient chooses to remove their waste helps to reduce the frequency with which the patient must operate the valve device to remove waste. Gas passing through the primary gas permeable filter 338 and the secondary gas permeable filter 339 is directed through one or more inlet ports 342a-b of the filtration plate 340. The filtration plate 340 is secured to the back side of the substrate 302 to form a filtration cavity 344 between the substrate 302 and the filtration plate 340. The filtration plate 340 can be secured to the substrate 302 by adhesive bonding or any other type of bonding, such as ultrasonic welding. The filtration cavity 344 can be filled with an odor absorbing material. The odor absorbing material includes, but is not limited to, activated carbon. The activated carbon absorbs odors from the gas passing through the filtering cavity before the gas exits the valve device 300 through the multiple outlet ports 329. In this manner, the valve device 300 can continuously emit filtered gas that is free of unpleasant odors, while the patient can choose when to open and close the valve device 300 to remove liquid and solid waste.

[0028] In addition to providing a seal and filter for gas between the stem 316 and the patient's stoma, the gas permeable filter 338 also provides a soft interface between the stoma and the valve device 300. A soft interface is important to ensure that the valve device 300, which can be worn in place for several days before being removed and replaced, does not irritate the stoma. In addition to covering the stem 316, the secondary gas permeable filter 339, and the inlet port(s) 342a-b, the gas permeable filter 338 can also cover the exterior surface of the filtration plate 340. In this way, the gas permeable filter 338 can provide a soft interface between all surfaces of the valve device 300 that come into contact with the patient's stoma. Instead of the gas permeable filter 338, an alternative soft material, such as a gauze dressing typically used for wounds, can also be used to cover the exterior surface of the filtration plate 340 to provide a soft interface between the valve device 300 and the patient's stoma. In yet another embodiment shown in FIG. 9D, the primary gas permeable filter / seal 338 is configured as an annular disk filter / seal that is mounted around the stem 316. When configured as an annular disk filter / seal, the primary filter / seal 338 may be a multi-layer structure where each layer is designed to filter a particular particle size. For example, the first inner layer 338a may have a filter pore size in the range of about 0.2-1.0 millimeters to remove macroscopic solids (exemplary materials include polyurethane foam, metal mesh, vinyl mesh), the second middle layer 338b may have a filter pore size in the range of about 10-50 microns to capture microscopic solids (exemplary materials include polypropylene or rayon), and the third outer layer 338c may have a filter pore size in the range of about 0.2-0.5 microns to prevent liquid from entering the inlet ports 342a,b (exemplary materials include PTFE). In this manner, clogging of the filter can be reduced and gas can be allowed to pass while still sealing against liquid leakage into the filtering cavity 344 .

[0029] As discussed above, the valve device 300 may be attached to the patient using an annular disk attachment member, such as an adhesive wafer 206. To this end, the substrate 302 may include an annular substrate clip 341 configured to engage with a wafer clip 243, as shown, for example, in FIG. 2C (which alternatively engages with the substrate clip 241 of the substrate 202). Alternative means of patient attachment, as discussed above, may also be used. The substrate 302 is also preferably formed with an internal dome shape to accommodate the patient's stoma, which may protrude from the surrounding skin surface, as shown, for example, in FIG. 9C.

[0030] Valve cover 307 and seal 321 have been removed from Figures 10A and 10B to show operation of valve device 300. Valve gate 304 is comprised of a body 360, gate guides 351a and 351b on either side of body 360, cantilever arms 363a and 363b at one end of body 360, and valve handles 305a and 305b at the ends of cantilever arms 363a and 363b. Valve gate 304 is restrained and held in a closed position relative to substrate 302 by lateral stops 361a and 361b protruding from cantilever arms 363a and 363b that abut stop shelves 367a and 367b on substrate 302. To open gate valve 304, the patient squeezes valve handles 305a and 305b toward each other and pulls gate valve 304 in the direction of "arrow O." Squeezing the valve handles 305a and 305b towards each other deflects the cantilever arms 363a and 363b. This displaces the lateral stops 361a and 361b so that they are free from the stop shelves 367a and 367b. The gate guides 351a and 351b slide against the sides 353a and 353b of the substrate slot 350, continuing to move the gate valve in the direction of arrow O' until the gate guides 351a and 351b abut against the slot shelves 355a and 355b. When the gate guides 351a and 351b abut against the slot shelves 355a and 355b, the gate opening 309 through the gate valve 304 is aligned with the waste passageway 328 and waste can exit the patient. The patient can press the valve handles 305a and 305b in the direction opposite to the arrow O' to close the gate valve 304. Although the valve device 300 shown in Figures 9A-10B has only one set of side catches 361a, 361b and stop ledges 367a, 367b that hold the gate valve 304 in a locked state until the patient wishes to open the valve device 300 to remove waste material, the valve device 304 may be configured with another set of catches and ledges that hold the gate valve 300 open until the patient wishes to close the valve device 300. For example, the closed pockets 267a-b and open pockets 269a-b that engage the detents 261a-b of the valve device 200 are shown to lock the gate valve 200 in both the closed and open positions.

[0031] In a further alternative, a valve device according to the present disclosure may be configured without a stem or a gas passageway, as shown in Figure 9E. As one such example, alternative valve device 300A is configured substantially similarly to valve device 300, but without stem 316, nor the ports, filters, and passageways associated with a gas vent path.

[0032] 11A and 11B show an alternative embodiment of the waste bag clip 384 in which the pouch 282 that would be connected to the waste bag clip 384 is not shown in order to highlight the features of the waste bag clip 384. The waste bag clip 384 is comprised of one or more hooks 386a and 386b configured to hold the waste bag clip 384 to the valve apparatus 300 and one or more tabs 387. The waste bag clip 384 also has an opening 390 configured to engage with the outlet port 332 of the valve apparatus 300 to ensure that waste exiting the outlet port 332 enters the pouch 282 and does not leak or spill out. The one or more tabs 387 have one or more guide surfaces 389a and 389b configured to align the one or more tabs 387 with the clip pocket 313 of the substrate 302 of the valve apparatus 300 (see FIGS. 9A-9C and 12). To attach the waste bag clip 384 to the substrate 302, the one or more tabs 387 of the waste bag clip 384 are placed within the clip pocket 313 of the substrate 302. The guide surfaces 389a and 389b of the one or more tabs 387 mate with the sides 315a and 315b of the clip pocket 313 to facilitate placement of the one or more tabs 387 within the clip pocket 313. The waste bag clip 384 is then pressed against the substrate 302 until the one or more hooks 386a and 386b of the waste bag clip 384 capture the one or more bag clip engagement tabs 317a and 317b of the substrate 302. Once the waste bag clip 384 and therewith the waste bag 28 are securely attached to the valve apparatus 300, the patient may open the valve gate 304 and remove waste from the body. Although the valve device 300 or 200 may be used without the waste bag clip to remove waste from the body into a toilet like receptacle, the use of the waste bag 280 allows for easier and cleaner disposal for the patient.

[0033] The substrate 302, gate valve 304, valve cover 307, and bag clip 384, as well as the filtration plate 340, may all be manufactured from materials similar to those described herein for the substrate 202, gate valve 204, valve cover 207, and bag clip 284. Similarly, the stem 316 may be manufactured from materials similar to those described herein for the stem 216. Also, while in this example the stem 316 is shown shorter than the stems of other embodiments, such as stem 216, it should be noted that stems of various lengths or no stems may be utilized with any of the disclosed embodiments. If a stem is included, it may vary in length from having an inner end that is approximately flush with the inner surface of the substrate to a longer stem as shown in the various embodiments. One factor influencing the length of the stem is patient comfort. Also, certain vent designs may require longer or shorter stems.

[0034] 13A-E show another alternative embodiment of a valve device 400. The valve device 400 comprises a substrate 402, an adhesive wafer 406, a ball valve 434, a valve lock 401, and a stem 416. The substrate 402 is configured to have a ball cavity 420 and a tube cavity 422 on the front side. The ball cavity 420 is configured with two side slots 433a-b. The ball cavity is configured to receive a ball valve 434, and the side slots 433a-b are configured to receive a ball axle 435a-b. The ball valve 434 pivots relative to the substrate 402 about an axis formed by the ball axles 435a-b. The substrate also includes one or more filter cavities 453a-b. The one or more filter cavities 453a-b are covered by one or more filter cavity covers 452a-b. The one or more filter cavity covers 452a-b include an odor absorbing material within the one or more filter cavities 453a-b. The one or more filter cavity covers 452a-b can be attached to the substrate 402 by adhesive bonding or any other type of bonding including ultrasonic welding, solvent bonding, insert molding, etc. The one or more filter cavity covers 452a-b include a plurality of openings 454 that allow gas to pass through the odor absorbing material in the one or more filter cavities 453a-b and out of the valve apparatus 400. The substrate 402 is configured with one or more ribs 494 on a backside thereof that interface with one or more grooves 492 in the adhesive wafer 406 to securely attach the substrate 402 to the adhesive wafer 406. The ribs 494 and grooves 492 can be attached by adhesive bonding or any other type of bonding including ultrasonic welding, solvent bonding, insert molding, etc.

[0035] The adhesive wafer 406 comprises one or more grooves 427. The one or more grooves 427 may be on either the front or back of the adhesive wafer 406 to provide a more flexible adhesive wafer 406 and optimize the conformance and adhesion of the adhesive wafer 406 to the patient's skin. The back side of the adhesive wafer 405 comprises a skin compatible adhesive to ensure that the valve device 400 is adhered to the patient's skin for several days and keeps the valve device 400 in place without irritating the patient's skin.

[0036] The ball valve 434 also includes an outlet nozzle 404 and ends with an outlet port 415. The ball valve 434 also has a bottom port 418 which communicates with an outlet port 516 by a nozzle passage 417 (see FIG. 14C).

[0037] The valve lock 401 comprises an elongated rod 403 having an end face 413 at one end and a lock handle 405 at the other end. The valve lock 401 also has a wiping end 425 adjacent the end face 413. The elongated rod 403 fits into a nozzle passage 417 of a ball valve 434, with the wiping end 425 extending beyond the outlet nozzle 404. The outer diameter of the wiping end 425 is larger than the inner diameter of the nozzle passage 417 to hold the valve lock 401 inside the ball valve 434. The valve lock 401 prevents the ball valve 434 from rotating, locking the ball valve 434 and keeping the valve device 400 closed. The valve lock 401 also has a guide channel 410 with a guide stop 414 adjacent the end face 413. The guide channel is configured to slide over a stop boss 412 on the substrate 402. As described further herein, when the valve lock 401 is actuated, the stop boss 412 prevents the valve lock 401 from rotating and the guide stop 414 prevents the valve lock 401 from being separated from the valve device 400.

[0038] The stem 416 is attached to the substrate 402 and is covered by a gas permeable filter 438. The rear end of the stem 416 has an inlet port 430 that allows waste material to enter the waste passageway 428. The front end of the stem 416 is compressed against a ball valve 434 to prevent waste material from escaping the stem when the valve device 400 is in the locked position. The gas permeable filter 438 is comprised of one or more cores 439 that pass through slots 440 in the substrate 402 into one or more filter cavities 453a-b.

[0039] 14A, 14B, and 14C show the valve device 400 in an open position. To open the valve device 400, the patient first holds the lock handle 405 and slides the valve lock 401 in the direction of the arrow O'. This action retracts the wiping end 425 into the outlet port 415 and through the nozzle passage 417 of the ball valve 434. When the valve lock 401 is fully withdrawn from the ball valve 434, the guide stop 414 contacts the stop boss 412 of the substrate 402, preventing further translation of the valve lock 401. The patient then holds the outlet nozzle 404 of the ball valve 434 and pivots the ball valve 434 about the axis formed by the ball shafts 435a-b. This moves the ball valve 434 from the horizontal locked position to the vertical open position. In this open position, a continuous opening is formed starting at the inlet port 430 at the end of the stem 416, through the waste passage 428 in the stem 416, to the bottom port 418 of the ball valve 434, through the nozzle passage 417 in the outlet nozzle 404, and ending at the outlet port 415. In this manner, waste material can enter the valve device 400 through the inlet port 430 and exit through the outlet port 415, allowing the patient to remove the waste material from their body.

[0040] After the patient has removed all waste, he or she can rotate the ball valve 434 back to the horizontal position to close the valve device 400. The patient can then slide the valve lock 401 back into the ball valve 434. The wiping tip 425 is forced through the nozzle passage 417 of the outlet nozzle 404, into the bottom port 418, and out the outlet port 415. This action of the valve lock 401 with the wiping tip 425 adjacent the end face 413 sweeps out any waste that may still be present in the nozzle passage 417. As a result, the ball valve 434 is clean until the next time the patient wants to activate the valve device 400 to open it.

[0041] Substrate 402, ball valve 404, cavity covers 452a-b, and valve lock 401 may all be fabricated from materials similar to those described herein for substrate 202, gate valve 204, and valve cover 207. Similarly, wafer 406, stem 416, gas permeable filter 438, and wiping tip 425 may be fabricated from materials similar to those described herein for wafer 206 and stem 216, gas permeable filter 238, and annular seal 221, respectively.

[0042] In further alternative embodiments, the valve device may be configured substantially as described above, but without the gas venting path. In some cases, the need for gas venting may be correlated with the patient's personal habits, such as bowel movement frequency and diet. Thus, patients who do not require gas venting may prefer the greater control that may be afforded by a valve device without venting functionality. Furthermore, in some embodiments, it may be preferable not to include a stem component, otherwise constituting an embodiment of a valve device according to embodiments described herein. Removing the stem component for some patients may improve the comfort of the device. Furthermore, since one purpose of the stem in some embodiments is to form functionally separate pathways for the excretion of gaseous waste versus liquid / solid waste, it may be desirable to omit the stem component in embodiments without venting functionality.

[0043] In view of the above, the improvements discussed herein can facilitate the evacuation of waste from the stoma. In embodiments, a material is employed that self-seals with surfaces within the patient's body. This feature eliminates the need for the patient to interact with an appliance to properly secure the device in place, so as to avoid leaks or other potential mistakes that may allow waste to inadvertently be evacuated from the stoma.

[0044] The above is a detailed description of an exemplary embodiment of the present disclosure. It should be noted that in this specification and the appended claims, conjunctive language such as used in the phrases "at least one of X, Y, and Z" and "one or more of X, Y, and Z" shall be interpreted to mean that each item of the conjunctive list can be present in any number except all other items of the list, or in any number in combination with any or all other items of the conjunctive list, each of which can be present in any number, unless otherwise stated or indicated. Applying this general rule, the conjunctive phrase in the above example where the conjunctive list is composed of X, Y, and Z shall respectively include one or more X, one or more Y, one or more Z, one or more X and one or more Y, one or more Y and one or more Z, and one or more X, one or more Y, and one or more Z.

[0045] Various modifications and additions can be made without departing from the spirit and scope of the present disclosure. Each feature of the various embodiments described above may be combined with features of other described embodiments, as appropriate, to provide multiple feature combinations in related new embodiments. Moreover, while the above describes several separate embodiments, what is described herein is merely illustrative of the application of the principles of the present disclosure. Furthermore, although certain methods herein may be illustrated and / or described as being performed in a particular order, the ordering is highly variable within the scope of one of ordinary skill in the art to achieve aspects of the present disclosure. Thus, this description is intended to be taken only as an example, and is not intended to limit the scope of the present disclosure.

[0046] Exemplary embodiments have been disclosed above and shown in the accompanying drawings. It will be understood by those skilled in the art that various modifications, omissions and additions may be made to what is specifically disclosed herein without departing from the spirit and scope of the present disclosure.

Claims

1. a support member configured to surround a stoma of a patient, the support member having an inner side, a skin-facing side, and an outer side; a base member removably attachable to the center of said support member and defining a first solid-liquid flow path and a second gas vent flow path therethrough and therein, each having at least one opening; a valve disposed on the base member and configured to control flow in the first flow path, the valve having an open position to allow flow and a closed position to block flow, the valve being operable by the patient to move between the open and closed positions; a stem projecting inwardly from the body member and having an inlet and an outlet configured to be received in a stoma of the patient; a gas-permeable filter seal surrounding the stem and covering the opening of at least one second gas vent passage; Equipped with the stem has a length sufficient to extend through a center of the support member to position the inlet at the stoma when the base member is attached to the support member and the outlet at an opposite end thereof communicates with an opening of the first flow channel in the base member; Gas from the stoma can be vented through the second flow path while liquids and solids are prevented from entering the second flow path. Stoma valve device.

2. 10. The stoma valve appliance of claim 1, wherein the base member has an inwardly facing concave surface shaped to accommodate a patient's stoma protruding through the center of the support member.

3. 3. The stoma valve appliance of claim 2, further comprising means for securing the support member to the patient's skin on an inner, skin-facing side of the support member.

4. The stoma valve appliance of claim 3 , wherein the means for securing comprises an adhesive substance.

5. 10. The stoma valve appliance of claim 1, wherein the gas permeable filter seal comprises multiple filter layers having different pore sizes.

6. 6. The stoma valve appliance of claim 5, wherein the gas permeable filter seal comprises a sleeve at least partially surrounding the stem configured to extend into the stoma between the stem and the patient.

7. 6. The stoma valve appliance of claim 5, wherein the gas permeable filter seal comprises a disc filter member through which the stem extends.

8. 8. The stoma valve appliance of claim 1, wherein the gas vent flow path of the base member terminates in at least one evacuation port on an opposite side of the interior of the base member, and the base member defines at least one filtering cavity within the gas vent flow path between the at least one interior opening and the at least one evacuation port.

9. 9. The stoma valve appliance of claim 8, wherein at least one filtering cavity comprises an odor absorbing material.

10. 8. A stoma valve appliance according to any preceding claim, wherein the support member and base member are attached by being pressed together.

11. 11. The stoma valve appliance of claim 10, wherein the support member and base member each have opposing engaging surfaces that engage and secure the members together when pressed together.

12. 12. The stoma valve appliance of claim 11, wherein the opposing engagement surfaces are resilient hook-shaped.

13. The stoma valve appliance of claim 11 , wherein the opposing engagement surfaces comprise interlocking ribs and grooves.

14. 8. A stoma valve appliance according to any preceding claim, wherein the support member and base member are attachable by a threaded connection.

15. 8. A stoma valve appliance according to any preceding claim, further comprising an outlet nozzle terminating the first flow path through the base member opposite the internal opening.

16. Further comprising a waste collection bag; The waste collection bag comprises: Pouch and a connector sealed to the pouch having an opening configured to mate with the outlet nozzle to receive solids and liquids from the outlet nozzle; a first engagement means disposed on the connector; second engaging means disposed on the base member and configured to engage with the first engaging means to secure the waste collection bag to the base member with the outlet nozzle engaged with the connector opening; 16. The stoma valve appliance of claim 15, further comprising:

17. 17. The stoma valve appliance of claim 16, wherein the valve is a gate valve.

18. 18. The stoma valve appliance of claim 17, wherein the gate valve comprises a valve gate slidably mounted to the base member.

19. 20. The stoma valve appliance of claim 18, wherein the valve gate includes a detent locking mechanism engageable with the base member to lock the valve gate in the closed position.

20. 20. The stoma valve appliance of claim 19, wherein the detent locking mechanism forms a user-operable handle on the valve gate.

21. 17. The stoma valve appliance of claim 16, wherein the valve is a ball valve.

22. 22. The stoma valve appliance of claim 21, wherein the ball valve comprises a ball member and a nozzle member, the ball member being rotatably received within a spherical notch in the base member such that the ball member rotates from a closed position in which the nozzle is positioned relative to the base member to an open position in which the nozzle extends outward from the base member.

23. 23. The stoma valve appliance of claim 22, wherein the ball valve further comprises a locking plunger configured to slide along the base member into the ball valve nozzle when in the closed position to prevent rotation of the ball valve to the open position and force waste out of the nozzle.

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