CN118019513A - Devices, systems and methods for regulating the discharge of a patient's stoma - Google Patents

Abstract

A medical device is provided with a material that forms a liquid barrier with the inner wall of a patient's stoma. These arrangements may comprise an annular disc with a valve stem inserted into the stoma on one side. For example, the material may be present on the valve stem in the form of a replaceable hollow tube that covers at least a portion of the valve stem. On the other side, a rotatable plug is inserted into the recess. The first position of the rotatable plug forms a passageway through the valve stem and the annular disc for the discharge of faeces from the stoma. In one embodiment, the rotatable plug may be connected to a collection device that receives fecal matter. The patient may pull the rotatable plug back to the second position to prevent fecal matter from escaping.

Description

Devices, systems and methods for regulating the discharge of a patient's stoma

Data of related applications

The present application claims priority from U.S. provisional patent application 63/270,808 entitled "Devices, SYSTEMS AND Methods for Regulating Flow From a Stoma on a Patient," filed on 10/22 of 2021. The present application also claims priority from U.S. non-provisional patent application 17/846,863 filed on day 22 of 6.2022. The entire disclosures of these two co-pending patent applications are incorporated herein by reference.

Technical Field

The present disclosure relates generally to the field of osteotomy instruments. In particular, the present disclosure relates to devices, systems and methods for regulating the discharge of a patient stoma.

Background

Surgical procedures often require post-operative access to a patient's body cavity to expel fluids or excretions that may cause infection. A "stoma" is an example of the creation of a passageway by surgery. In one common application, an ostomy is an opening that allows fecal matter in the patient's intestinal tract to exit the body after a colostomy or ileostomy. The faeces are collected in a device, such as a bag or a pouch, which may be fixed around the stoma or connected to the stoma by means of a drainage tube. While this conventional arrangement is effective in draining, the patient is generally unable to control fecal matter because the fecal matter can drain uncontrollably into a collection device attached to the drain. The patient may choose to occlude the drainage channel using, for example, a plug (in the stoma) or a clip (on the drain tube), but this may cause discomfort because the stoma cannot withstand prolonged occlusion. Damage to the drain tube may also cause faeces to leak before reaching the collecting device.

Disclosure of Invention

In one embodiment, the present disclosure relates to an ostomy valve device comprising an annular support member configured to encircle a patient's stoma and having an inner side and an outer side facing the skin; a base member detachably mounted on a center of the annular support member, the base member defining first solid and liquid flow paths and second gas discharge flow paths through the base member, each flow path having at least one opening on an inner side of the base member; a valve disposed in the base member, the valve configured to control outflow through the first flow path, the valve having an open position allowing outflow and a closed position preventing outflow, and the valve being operable by the patient between the open position and the closed position; a valve stem having an inlet and an outlet, the valve stem projecting inwardly from the body member and configured to be received within a patient's stoma, the valve stem having a length sufficient to extend through a center of the annular support member such that when the base member is mounted on the annular support member, the inlet is positioned in the stoma and the outlet is located at an opposite end in communication with the opening of the first flow path in the base member; and a gas permeable filter seal surrounding the valve stem, the gas permeable filter seal covering the opening of the at least one second gas discharge flow path so that gas can be discharged from the stoma through the second flow path while preventing liquids and solids from entering the second flow path.

In another embodiment, the present disclosure relates to a patient-controlled method of discharging fecal matter from a stoma. The method comprises placing an outlet valve device in the stoma, the outlet valve device having a closed position preventing faeces from exiting the stoma and an open position allowing faeces to exit the stoma; the patient selectively moves the valve means between an open position and a closed position to expel fecal matter from the stoma or to retain fecal matter within the stoma for later expulsion; and continuously exhausting gas from the stoma through the valve arrangement in the open and closed positions.

In another embodiment, the present disclosure relates to an ostomy valve device comprising an annular support member configured to encircle a patient's stoma and having an inner side facing the skin and an outer side; a skin adhesion layer provided on the inner side of the annular supporting member facing the skin; a base member detachably connected to a center of the annular support member, the base member defining a flow path through the base member, the flow path having an opening on an inner side of the base member; a valve disposed in the base member, the valve configured to control the discharge of the flow path, the valve having an open position allowing outflow and a closed position preventing outflow, and the valve being operable by the patient between the open position and the closed position; and an outlet nozzle terminating a first path through the base member and opposite the inboard opening that receives outflow through the valve in the open position.

Drawings

For the purpose of illustrating the disclosure, the drawings show aspects of one or more embodiments of the disclosure. However, it should be understood that this disclosure is not limited to the particular arrangements and instrumentality shown in the drawings, wherein:

FIG. 1 depicts a schematic view of an exemplary embodiment of a valve device mounted in place on a patient.

Fig. 2A is a perspective view of an embodiment of a valve device.

Fig. 2B is a front view of the embodiment of the valve device shown in fig. 2A.

Fig. 2C is a cross-sectional view through line A-A of the embodiment of the valve device shown in fig. 2B.

Fig. 3A is an exploded perspective view of the embodiment of the valve device shown in fig. 2A.

FIG. 3B is an exploded cross-sectional view of the embodiment of the valve assembly shown in FIG. 3A through line A-A (as shown in FIG. 2B).

Fig. 4A is a front view of a portion of the assembly of the embodiment of the valve device shown in fig. 2A in a closed configuration.

Fig. 4B is a front view of a portion of the assembly of the embodiment of the valve device shown in fig. 2A in an open configuration.

Fig. 5 is a cross-sectional view through line a '-a' of a portion of the assembly of the embodiment of the valve device of fig. 2A in the open configuration of fig. 4B.

Fig. 6A is a front perspective view of an effluent collection device for use with the embodiment of the valve device shown in fig. 2A.

Fig. 6B is a rear perspective view of the effluent collection device shown in fig. 6A.

Fig. 7 is a perspective view of the effluent collection device of fig. 6A in combination with the embodiment of the valve device of fig. 2A.

Fig. 8 is a perspective view of a portion of the assembly of the effluent collection device of fig. 6A in combination with a portion of the assembly of the valve device of fig. 2A.

Fig. 9A is a perspective view of another embodiment of a valve device.

Fig. 9B is a front view of the embodiment of the valve device shown in fig. 9A.

Fig. 9C is a cross-sectional view through line B-B of the embodiment of the valve device shown in fig. 9B.

Fig. 9D is a cross-sectional view of the valve device shown in fig. 9A and 9B with an alternative filter seal arrangement.

Fig. 9E is a cross-sectional view of another valve device similar to fig. 9A, but without a valve stem or exhaust port.

Fig. 10A is a front view of a portion of the assembly of the embodiment of the valve device shown in fig. 9A in a closed configuration.

Fig. 10B is a front view of a portion of the assembly of the embodiment of the valve device shown in fig. 9A in an open configuration.

Fig. 11A is a rear view of an alternative effluent collection device clip.

Fig. 11B is a side view of the alternative effluent collection device clip shown in fig. 11A.

Fig. 12 is a perspective view of the valve assembly of fig. 9A in combination with an alternative effluent collection device clip of fig. 11A-B.

Fig. 13A is a perspective view of another embodiment of a valve device.

Fig. 13B is a front view of the embodiment of the valve device shown in fig. 13A.

Fig. 13C is a cross-sectional view through line C-C of the embodiment of the valve device shown in fig. 13B.

Fig. 13D is a cross-sectional view through line D-D of the embodiment of the valve device shown in fig. 13B.

Fig. 13E is a cross-sectional view through line E-E of the embodiment of the valve device shown in fig. 13B.

Fig. 14A is an exploded perspective view of the embodiment of the valve device shown in fig. 13A in an open configuration.

Fig. 14B is a front view of the embodiment of the valve device shown in fig. 14A.

Fig. 14C is a cross-sectional view through line F-F of the embodiment of the valve device shown in fig. 14B.

Wherever applicable, like reference numerals refer to the same or corresponding components and units throughout the several views (not to scale unless otherwise indicated). Embodiments disclosed herein may include elements that appear in one or more views, or elements that appear in a combination of multiple views. The method is merely exemplary and modifications may be made by reordering, adding, deleting, and/or altering the various phases, etc.

Detailed Description

A medical device that can be engaged with a surgically created stoma of a patient will be described below. These devices allow the patient to periodically drain the body waste into a bag or container for proper disposal. The proposed design allows the patient to control the discharge in a convenient manner while maintaining proper engagement with the stoma to minimize leakage of faeces or other unintended discharge.

Fig. 1 depicts a schematic diagram of an exemplary embodiment of a valve apparatus 100. The present embodiment is shown on patient P, typically at a location on patient P where post-operative access to the body cavity is desired. This location may have a stoma or opening that allows faeces to be discharged from the patient P to a collecting device, such as a bag or pouch (not shown). The device 100 may include a support unit 102, the support unit 102 housing a plug 104. The sealing unit 106 may be located on a portion of the support unit 102 to engage with the stoma interior.

Fig. 2A and 2B depict another embodiment of a valve device 200, the valve device 200 being configured to be coupled to a patient's stoma to allow the patient to control the discharge of fecal matter through the stoma. The valve device 200 includes a base 202, the base 202 being connected to an adhesive wafer 206, the adhesive wafer 206 being a relatively thin flexible annular disc. The back surface 212 of the adhesive wafer 206 is provided with an adhesive for securing the valve device 200 to the patient's skin. For example, the adhesive surface 258 (fig. 3B) on the adhesive wafer 206 may adhere the adhesive wafer 206 to the skin. The adhesive surface 258 may be comprised of any type of skin compatible adhesive, such as a gel hydrogel adhesive. The adhesive wafer 206 may also include a removal tab 219 for providing assistance to the patient when the patient wants to remove the adhesive coated wafer from the skin, and a curved engagement 203, the curved engagement 203 enabling the adhesive wafer 206 to closely follow the irregular contours of the patient's skin. The base 202 has one or more pocket clip engagement slots 213a and 213b, and one or more pocket clip engagement tabs 217a and 217b. The pouch clip engagement slots 213a and 213b and the pouch clip engagement tabs 217a and 217b are configured to secure a pouch clip, as will be described later. The base 202 engages a gate valve 204 located in front of the base 202. One end of the gate valve 204 has a valve handle 205 to enable a patient to open and close the gate valve 204, as will be described below. Gate valve 204 is secured to base 202 by valve cover 207. The bonnet 207 and the base 202 limit the gate valve 204 but allow the gate valve 204 to slide open and closed as will be further described below. The valve cover 207 includes an outlet nozzle 226 for directing effluent away from the valve assembly 200. The outlet nozzle 226 may be covered by the nozzle cover 208 when the patient is not operating the valve apparatus 200 to discharge effluent. The nozzle cover 208 is connected to the base portion 202 by a constraint 211. The restraint 211 will maintain the nozzle cover 208 in connection with the valve assembly 200 when the patient removes the nozzle cover 208 from the outlet nozzle 226.

Fig. 2C depicts an embodiment in which base portion 202 is engaged with adhesive wafer 206 by base clip 241, wherein base clip 241 is engaged with wafer clip 243. The base portion and adhesive wafer can be joined and separated as needed using base clip 241 on base portion 202 and wafer clip 243 on adhesive wafer 206. For example, a patient may wish to secure the base 202 to a smaller diameter adhesive wafer 206 that conforms better to the skin than a standard diameter adhesive wafer 206. Also, the patient may wish to attach the base portion 202 to an adhesive wafer 206 having different types of adhesives that are more compatible with the patient's skin. Compatibility of the adhesive with the patient's skin is a very important feature of the valve device 200 because the patient will adhere the valve device 200 to the skin for 2 days or more and then remove the valve device 200 to replace a new valve device. The adhesive wafer 206 also includes an annular opening 218 and the base 202 includes a dome-shaped cavity 214. The annular opening 218 and dome-shaped cavity 214 are configured to cover a patient's stoma without stressing or affecting the stoma, which typically protrudes from the skin surface of the patient. By providing a cavity consisting of an annular opening 218 and a dome-shaped cavity 214, it is important to accommodate the stoma without irritating the stoma. The size and shape of the stoma of a patient may change over time, so that the patient may change adhesive wafer 206 of a different size and/or with a different adhesive type. Or in some embodiments, the adhesive wafer 206 may be configured to allow the patient to trim the annular opening to accommodate the particular size and shape of the patient's stoma. Likewise, the base 202 may be interchanged with other bases to provide a dome-shaped cavity 214 that best matches the shape and size of the stoma. Thus, the two-piece configuration disclosed herein has a further advantage in terms of patient comfort, based on the patient's ability to control and change shape and adhesion type over time without the need to replace the entire device.

Base clip 241 and wafer clip 243 are not the only possible configurations for detachably connecting base 202 and adhesive wafer 206. In an alternative embodiment, base clip 241 and wafer clip 243 may be replaced with interlocking threads so that base 202 and adhesive wafer 206 may be screwed together or unscrewed. If threads are used instead of base clip 241 and tab clip 243, a stop, latch, compression washer, or other limiting device may be required in addition to the threads to prevent the threads from disengaging in unintended situations. An interlocking rib and groove arrangement may also be used, as shown in fig. 13D and described below. Other removable attachment means may be used, such as hook and loop fastening means and other snap or interference fit means.

The valve cover 207 is provided with an annular recess 223 for receiving the annular seal 221. An annular seal 221 is positioned against the valve cover 207 and the valve gate 204 to ensure that no effluent seeps between the valve cover 207 and the valve gate 204. The annular seal 221 may be an O-ring seal. The annular seal 221 may also be any other type of seal that is commonly used to prevent leakage of liquid between two components. The annular seal 221 may also be adhesively or otherwise bonded to the valve cover 207 rather than being pressed against the valve cover 207. The annular seal 221 may also be molded onto the valve cover 207.

A valve stem 216 is provided on the back of the valve assembly 200, the valve stem 216 being covered by a breather filter 238. The rear end of the valve stem 216 has an inlet port 230 that allows the exhaust to enter the drain channel 228. As shown in fig. 2C, the valve 204 is in a closed position, thus blocking the drainage channel 228 and preventing outflow from the patient's stoma into the drainage channel 228. The air permeable filter 238 is configured to abut against the stoma inner diameter, preventing leakage of effluent between the outer surface of the air permeable filter 238 and the stoma.

As shown in fig. 3B, the front end of the valve stem 216 is comprised of a slot 270 and a protrusion 274. The groove 270 is configured to contact a boss 272 on the base 202 to connect the valve stem 216 with the base 202. The connection between the slot 270 and the boss 272 may be a simple overlapping connection. The connection may also include an adhesive or similar bond between the slot 270 and the boss 272. The annular seal 216 may also be molded onto the valve cover 202. The protrusions 274 are configured to seal against the back of the gate valve 204 to prevent leakage of effluent from the drain channel 228 around the gate valve 204.

Referring to fig. 3A, the valve cover 207 has a constraint groove 253 thereon for receiving and constraining the constraint tab 251 on the end of the constraint 211 opposite the nozzle cover 208. While the restraint slot 253 is shown as part of the bonnet 207, it may also be configured as part of the base 202. The restraint slots 253 and restraint tabs 251 are just one possible method of securing the nozzle cover 208 and restraint 211 together with the remainder of the valve assembly 200. The restraint 211 may be glued or otherwise bonded to the bonnet 207 or the base 202. The restraint 211 may also be coupled to the bonnet 207 or the base 202.

The base 202 has a base opening 231 aligned with the drainage channel 228. The base opening 231 is also aligned with a bonnet opening 232 in the bonnet 207 at the forward end of the outlet nozzle 226. Gate valve 204 also has a gate opening 209. The inlet port 230, the drain channel 228, the base opening 231, and the bonnet opening 232 are all aligned to allow effluent to flow out through the valve apparatus 100. However, in the configuration shown in fig. 2A-C and 3A-B, the gate opening 209 is not aligned with the inlet port 230, drain channel 228, base opening 231, and valve cover opening 232, and the valve device 200 is closed by the gate valve 204.

The valve cover 207 and nozzle cover 208 of fig. 4A and 4B have been removed to facilitate the description of the operation of opening and closing the valve assembly 200. In fig. 4A, gate valve 204 is in a closed position, substantially aligned with base 202. The gate valve is shown with cantilevers 263a and 263b, the cantilevers 263a and 263b being constituted by arm slots 265a and 265 b. The ends of the cantilevers 263a and 263b have stoppers 261a and 261b. The stops 261a and 261b are secured in closed pockets 267a and 267b formed on the base 202. Stops 261a and 261b, and closure pockets 267a and 267b are configured to constrain gate valve 204 relative to base 202, preventing gate valve 204 from inadvertently sliding, thereby maintaining valve apparatus 200 closed. When a patient wants to open valve device 200, they will pull valve handle 205 in the direction indicated by arrow "O" in FIG. 4B. When the pulling force of the stoppers 261a and 261b against the closed pockets 267a and 267b is sufficiently large, the cantilevers 263a and 263b will bend into the arm grooves 255a and 265b, and the stoppers 261a and 261b will be released from the closed pockets 267a and 267 b. Gate valve 204 will then slide until stops 261a and 261b engage open pockets 269a and 269b formed in base 202. Then, the cantilevers 263a and 263b will spring back to secure the stoppers 261a and 261b in the open recesses 269a and 269 b. In this open configuration, the gate opening 209 of the gate valve 204 is aligned with the inlet port 230, drain passage 228, base opening 231, and valve cover opening 232, thereby forming a complete valve passage 278, as shown in fig. 5. In this configuration, the valve device 200 is in an open state and effluent may flow out of the patient's body. When the patient has cleared the effluent, the valve handle 205 is forcibly pressed in a direction opposite to arrow "O" to slide the gate valve 204 back to the closed position. In this way, the patient can control the time that the effluent flows out of the body.

As the effluent flows out of the valve cover opening 232, the effluent is preferably collected into a fecal bag 280, such as shown in fig. 6A and 6B. The faeces bag 280 is comprised of a bag 282 for holding faeces and a clip 284 for connecting the faeces bag 280 to a valve device, such as the valve device 200. Clip 284 is comprised of one or more hooks 286a and 286b and one or more tabs 287a and 287b for securing fecal bag 280 to valve device 200. Clip 284 also includes an opening 290 for engagement with outlet nozzle 226 to ensure that effluent flowing from outlet nozzle 226 enters bag 282 without leaking or spilling. The clip may also include a flap (plug) 288 that is connected to the clip by flexible tie 289. After the fecal bag 280 has collected the effluent from the valve device 200 and separated the fecal bag 280 from the valve device 200, the flap 288 can be used to seal the opening 290. The opening 290 may be configured with a seal to seal the outlet nozzle 226 or the flap 288 to ensure that the effluent does not leak at this connection.

In fig. 7 there is shown an faecal bag 280 connected to the valve device 200, the valve device 200 being in an open state, the patient's effluent being discharged through the valve device 200 into the faecal bag 280. In fig. 8, the bag 282 has been removed from the clip 284 to show details regarding how the fecal bag 280 is connected to the valve assembly 200. One or more tabs 287a and 287b of clip 284 are inserted into one or more pocket clip engagement slots 213a and 213b on base 202, and one or more hooks 286a and 286b on clip 284 snap into one or more pocket clip engagement tabs 217a and 217 b. This secures clip 284 and fecal bag 280 to valve assembly 200 and engages opening 290 of fecal bag 280 with outlet nozzle 226. In use, the patient first fits the fecal bag 280 over the valve assembly 200 and then pulls the valve handle 205 to open the gate valve 204. The effluent will then flow through the open valve device 200 and into the fecal bag 280. After all of the effluent has been expelled through the patient's stoma, the patient will push valve handle 205 to close gate valve 204. After the valve device 200 is closed, the patient will release the clip 284 and remove the fecal bag 280 from the valve device 200. The flap 288 can then be placed over the opening 290 of the fecal bag to prevent leakage of exudates. The nozzle cover 208 may also cover the outlet nozzle 226 of the valve apparatus 200.

The base 202, gate valve 204, valve cover 207, and pouch clip 284 may all be made of a rigid plastic resin such as, but not limited to, polypropylene, ABS, polycarbonate, and mixtures of any of these materials. These components may also be made of metal such as aluminum or stainless steel. The base portion of the adhesive wafer 206 may be made of a flexible material such as, but not limited to, silicone, polyurethane foam or film, TPE (thermoplastic elastomer), polyethylene foam or film, polyvinyl chloride foam, nitrile rubber, and mixtures of any of these materials. The adhesive portion of the adhesive wafer 206 may be made of an acrylic or elastomeric hydrocolloid adhesive or other skin compatible adhesive. The valve stem 216 may be made of a flexible material such as, but not limited to, silicone, polyurethane, TPU, TPE, polyethylene. The valve stem 216 may be made of a rigid or semi-rigid plastic resin such as, but not limited to, polypropylene, ABS, polycarbonate, and mixtures of any of these materials. The gas permeable filter 238 may be made of materials such as polyester, rayon, acrylic, polyethylene, polypropylene, cotton, and mixtures of these materials. These materials may have natural hydrophobic properties or may be treated with a coating (such as, but not limited to, difunctional polysiloxanes) to achieve hydrophobic properties. The annular seal 216 may be made of a flexible or semi-rigid material such as, but not limited to, silicone, polyurethane, TPU, TPE, and other elastomeric materials. The fecal bag 280 may be made of a flexible material such as, but not limited to, polyethylene, low density polyethylene, high density polyethylene, and other resin films.

In another alternative embodiment, the clip 284 described above may be mounted on a flexible drain tube (rather than the pouch 282) so that the patient directs the waste directly into the toilet. In another alternative, the outer diameter of one end of the flexible drain tube may be sized to have a slight interference fit with the inner diameter of the outlet nozzle 226, thereby firmly inserting the drain tube into the outlet nozzle 226 when desired. Or the inner diameter of one end of the drain tube is sized to have a slight interference fit with the outer diameter of the outlet nozzle 226 to secure the drain tube to the outlet nozzle 226 for introducing waste into the toilet. It may be more convenient for a patient to carry such a flexible drain tube in the event that the patient may use an appropriate faecal management device.

The above description of the valve device 200 is not intended to cover all possible variations of the valve device 200 to which the present disclosure relates. Turning now to fig. 9A, 9B and 9C, another embodiment of a valve assembly 300 is shown. The valve assembly 300 includes a base 302, a valve gate 304, a bonnet 307, a seal 321, a valve stem 316, and a filter plate 340. The base 302 includes one or more pouch clip engagement tabs 317a and 317b, one or more pouch clip recesses 313, and one or more pouch clip guides 315a and 315b for engaging a fecal pouch clip 384 (described further below). The base 302 also includes a plurality of vents 329 for venting gases through the valve assembly 300 as will be further described below. The valve cover 307 includes an outlet port 332 to allow effluent to exit the valve apparatus 300. A seal 321 is located between the gate valve 304 and the valve cover 307 to ensure that effluent does not leak between the gate valve 304 and the valve cover 307 (see fig. 9C). The valve stem 316 has an inlet 330, the inlet 330 allowing the effluent to enter the drain passage 328, the drain passage 328 passing through the center of the valve stem 316. The valve stem 316 may also seal the gate valve 304 to ensure that effluent does not leak between the valve stem 316 and the gate valve 304.

The valve stem 316 is surrounded by a primary air permeable filter 338, the primary air permeable filter 338 being configured to abut against the stoma inner diameter to prevent leakage of effluent between the outer surface of the primary air permeable filter 338 and the stoma. The valve stem 316 may also be surrounded by a secondary breather filter 339, the secondary breather filter 339 being sandwiched between the valve stem 316 and the primary breather filter 338. The secondary air permeable filter 339 may have a higher filtering accuracy than the primary air permeable filter 338. Providing more than one gas permeable filter allows valve device 300 to block solid matter and more viscous liquid matter with primary gas permeable filter 338 and to block all remaining liquid with secondary gas permeable filter 339 while allowing gas to pass. The valve device 300 is not limited to only two layers of filters. Any number of filter layers with different filtering capabilities are possible. The multi-layer filtration function can block liquid and solid matter and allow gas to pass through without the liquid and solid matter clogging the first layer filter.

The valve device 300 must allow the passage of gas so that the gas does not accumulate in the patient's digestive tract, resulting in uncomfortable pressure and feel. The valve device 300 is capable of sustained release of gas while maintaining liquids and solids until the patient chooses to remove the effluent, which helps reduce the frequency with which the patient operates the valve device to remove the effluent. The gas passing through the primary and secondary gas permeable filters 338, 339 is directed into one or more inlet ports 342a-b in the filter panel 340. The filter plate 340 is secured to the back of the base 302 to form a filter cavity 344 between the base 302 and the filter plate 340. The filter plate 340 may be secured to the base 302 by any other bonding means, such as adhesive or ultrasonic welding. The filter cavity 344 may be filled with odor absorbing material including, but not limited to, activated carbon. The activated carbon absorbs odors from the gas passing through the filter chamber before the gas exits the valve assembly 300 through the plurality of exhaust ports 329. In this manner, the valve device 300 can continuously release filtered gas without unpleasant odors while allowing the patient to select when to open and close the valve device 300 to clear liquid and solid effluents.

In addition to providing a seal between the valve stem 316 and the patient's stoma, the breather filter 338 also provides a soft interface between the stoma and the valve arrangement 300. The soft interface is important in ensuring that the valve device 300 does not irritate the stoma, wherein the valve device 300 may be worn for several days before being removed and replaced. In addition to covering the valve stem 316, the secondary breather filter 339, and one or more of the inlet ports 342a-b, the breather filter 338 may also cover the outer surface of the filter plate 340. In this manner, the breather filter 338 can provide a soft interface between all surfaces of the valve device 300 that contact the patient's stoma. Instead of the air permeable filter 338, another soft material (such as a gauze dressing commonly used for wounds) may be used to cover the outer surface of the filter plate 340, thereby providing a soft interface between the valve device 300 and the patient's stoma. In another alternative embodiment shown in fig. 9D, the primary breather filter/seal 338 is configured as an annular disc filter/seal mounted around the valve stem 316. When configured as an annular disc filter/seal, the primary filter/seal 338 may be a multi-layer structure, with each layer designed to filter a particular particle size. For example, the first inner layer 338a has a filter pore size in the range of about 0.2-1.0 millimeters (exemplary materials include polyurethane foam, metal mesh, vinyl mesh) to remove macroscopic solids; the second intermediate layer 338b has a filter pore size in the range of about 10-50 microns (exemplary materials include polypropylene or rayon) to capture small solids; the third outer layer 338c has a filter pore size in the range of about 0.2-0.5 microns (an exemplary material includes polytetrafluoroethylene) to prevent liquid from flowing into the inlet ports 342a, 342b. In this manner, clogging of the filter may be reduced, allowing gas to escape while continuing to seal, preventing liquid from escaping into the filter cavity 344.

The valve device 300 may be attached to the patient using an annular disc attachment member, such as the adhesive wafer 206 described above. To this end, the base 302 may be provided with an annular base clip 341 for engaging the sheet clip 243, such as shown in fig. 2C (where the sheet clip 243 is alternately engaged with the base clip 241 of the base 202). Other patient fixation means as described above may also be used. The base 302 preferably also forms an internal dome shape as shown in fig. 9C to accommodate a patient stoma that may protrude from the surrounding skin surface.

The valve cover 307 and nozzle cover 321 in fig. 10A and 10B have been removed to facilitate description of the operation of the valve assembly 300. The valve gate 304 includes a main body 360, valve guides 351a and 351b located at each side of the main body 360, cantilevers 363a and 363b located at one end of the main body 360, and valve handles 305a and 305b located at the ends of the cantilevers 363a and 363 b. The valve gate 304 is maintained in a closed position relative to the base 302 by lateral stops 361a and 361b, which extend from the cantilevers 363a and 363b and abut against stop ledges 367a and 367b on the base 302. To open the gate valve 304, the patient squeezes the valve handles 305a and 305b toward each other and pulls the gate valve 304 in the direction of arrow "O". Pressing the valve stems 305a and 305b toward each other deflects the cantilevers 363a and 363b, which in turn displaces the lateral stops 361a and 361b such that the lateral stops disengage the stop ledges 367a and 367b. The gate guides 351a and 351b slide against the sides 353a and 353b of the base slot 350 to hold the gate valve in the direction of arrow "O" until the gate guides 351a and 351b bear against the slot bosses 355a and 355b. When gate guides 351a and 351b are in abutment with slot bosses 355a and 355b, gate opening 309 is aligned with drain passage 328 via gate valve 304 and effluent may flow out of the patient. The patient may push valve handles 305a and 305b in the opposite direction of arrow "O" to close gate valve 304. While the valve device 300 shown in fig. 9A-10B has only one set of lateral stops 361a and 361B and stop bosses 367a and 367B for holding the locking gate valve 304 until the patient wants to open the valve device 300 to remove effluent, the valve device 300 may also include another set of stops and bosses for holding the gate valve 304 in an open state until the patient wants to close the valve device 300. For example, the closed pockets 267a-b and open pockets 269a-b engage with stops 261a-b in the valve apparatus 200, which means that the gate valve 200 can be locked in both the closed and open positions.

In another alternative embodiment, as shown in fig. 9E, the valve device of the present disclosure may not be configured with a valve stem or exhaust port. For example, the alternative valve device 300A is substantially identical in construction to the valve device 300, but without the valve stem 316 and without ports, filters, and passages associated with the exhaust ports.

Fig. 11A and 11B illustrate another embodiment of a fecal bag clip 384, wherein the bag 282 connected to the fecal bag clip 384 is not shown in order to highlight the features of the fecal bag clip 384. The fecal bag clip 384 includes one or more hooks 386a and 386b and one or more tabs 387 for securing the fecal bag clip 384 to the valve assembly 300. The fecal bag clip 384 also has an opening 390 configured to engage the discharge port 332 of the valve device 300 to ensure that the discharge exiting the discharge port 332 enters the fecal bag 282 without leaking or spilling. 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 pouch clip groove 313 on the base 302 of the valve device 300 (see fig. 9A-C and 12). To secure the fecal bag clip 384 to the base 302, one or more tabs 387 of the fecal bag clip 384 may be placed into the bag clip groove 313 on the base 302. Guide surfaces 389a and 389b on one or more tabs 387 interface with sides 315a and 315b of pouch clip groove 313 to place one or more tabs 387 into pouch clip groove 313. The fecal bag clip 384 is then pushed onto the base 302 until the one or more hooks 386a and 386b of the fecal bag clip 384 hook over the one or more fecal bag clip engagement tabs 317a and 317b on the base 302. Once the fecal bag clip 384 and fecal bag 28 are securely attached to the valve device 300, the patient can open the valve gate 304 to expel the effluent out of the body. The valve device 300 or 200 can drain exudates from the body into a toilet or similar container without the use of a fecal bag clip, but the use of the fecal bag 280 can allow for easier and cleaner drainage by the patient.

The base 302, gate valve 304, valve cover 307, and pocket clip 384, as well as the filter plate 340, may all be fabricated from materials similar to the base 202, gate valve 204, valve cover 207, and pocket clip 284 described herein. Likewise, the valve stem 316 may also be fabricated from materials similar to the valve stem 216 described herein. It should also be noted that while the valve stem 316 in this example is shorter than the valve stems (e.g., the valve stem 216) in other embodiments, in any of the embodiments disclosed, a valve stem of a different length may be used, or no valve stem may be used. The length of the valve stem, if any, may extend from its inner end substantially coplanar with the base inner surface to the longer valve stem shown in the various embodiments. One factor affecting the length of the valve stem is patient comfort. A longer or shorter valve stem may also be required for a particular vent design.

Fig. 13A-E illustrate another alternative embodiment of a valve device 400. The valve assembly 400 includes a base 402, an adhesive wafer 406, a ball valve 434, a valve lock 401, and a valve stem 416. The front face of the base 402 is configured with a ball cavity 420 and a lumen 422. Ball cavity 420 is configured with two side grooves 433a-b. The ball cavity is configured to receive a ball valve 434 and the side grooves 433a-b are configured to receive ball shafts 435a-b. Ball valve 434 is rotatable relative to base 402 about an axis defined by ball axes 435a-b. The base also includes one or more filter cavities 453a-b. One or more filter cavities 453a-b are covered by one or more filter cavity covers 452 a-b. One or more filter cavity covers 452a-b house odor absorbing material within one or more filter cavities 453a-b. One or more filter cavity covers 452a-b may be attached to base 402 with adhesive or any other type of bonding, including ultrasonic welding, solvent bonding, insert molding, etc. The one or more filter chamber covers 452a-b include a plurality of openings 454 for allowing gas to pass through the odor absorbing material in the one or more filter chambers 453a-b and out of the valve assembly 400. The back of the base 402 is provided with one or more ribs 494 which engage with one or more grooves 492 in the adhesive wafer to firmly secure the base 402 to the adhesive wafer 406. The ribs 494 and grooves 492 may be adhesively bonded or any other type of bonding, including ultrasonic welding, solvent bonding, insert molding, and the like.

The adhesive wafer 406 includes one or more grooves 427. One or more grooves 427 may be located on the front or back surface of the adhesive wafer 406 to make the adhesive wafer 406 more flexible, thereby optimizing the compliance and adhesion of the adhesive wafer 406 to the patient's skin. The back side of the adhesive wafer 405 includes a skin compatible adhesive to ensure that the valve device 400 can be adhered to the patient's skin for days to maintain the position of the valve device 400 without irritating the patient's skin.

Ball valve 434 also includes an outlet nozzle 404, with outlet nozzle 404 terminating in an outlet port 415. Ball valve 434 also has a bottom port 418 that communicates with outlet port 516 through nozzle passage 417 (see fig. 14C).

The valve lock 401 comprises an elongated rod 403 with an end face 413 at one end and a locking handle 405 at the other end. The valve lock 401 also has a wiping edge 425 adjacent the end face 413. The elongated stem 403 mates with the nozzle channel 417 of the ball valve 434, with the wiper edge 425 extending across the outlet nozzle 404. The wiper edge 425 has an outer diameter greater than the inner diameter of the nozzle passage 417, thereby securing the valve lock 401 within the ball valve 434 and the valve lock 401 prevents the ball valve 434 from rotating, thereby locking the ball valve 434 and maintaining the valve device 400 closed. The valve lock 401 also has a guide channel 410 with a guide stop 414 near an end face 413. The guide channel is configured to extend to a stop boss 412 on the base 402. When the valve lock 401 is actuated as will be further described herein, the stop boss 412 prevents the valve lock 401 from rotating, while the guide stop 414 prevents the valve lock 401 from being separated from the valve device 400.

The valve stem 416 is attached to the base 402, covered by a breather filter 438. The rear end of the valve stem 416 has an access port 430 that allows the exhaust to enter the drain passage 428. When the valve assembly 400 is in the locked position, the forward end of the valve stem 416 is pressed against the ball valve 434 to prevent leakage of effluent from the valve stem. The breather filter 438 includes one or more draft tubes (wicks) 439 that extend through slots 440 in the base 402 to one or more filter cavities 453a-b.

Fig. 14A, 14B and 14C show the valve device 400 in an open position. To open valve assembly 400, the patient first grasps locking handle 405 and then slides valve lock 401 in the direction of arrow "O". This action pulls the wiper edge 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 base 402, preventing further translation of the valve lock 401. The patient then holds the outlet nozzle 404 of the ball valve 434 and rotates the ball valve 434 about the axis formed by the ball shafts 435 a-b. Thus, the ball valve 434 is moved from the horizontal locking position to the vertical open position. In this open position, a continuous opening is formed from the inlet port 430 at the end of the valve stem 416, through the drain passage 428 in the valve stem 416, to the bottom port 418 on the ball valve 434, through the nozzle passage 417 in the outlet nozzle 404, and finally to the outlet port 415. In this manner, effluent may enter valve assembly 400 through inlet port 430 and be discharged through outlet port 415, allowing the patient to discharge the effluent from the body.

After all of the effluent is expelled, the patient may rotate ball valve 434 back to the flat position to close valve device 400. The patient may then slide the valve lock 401 back to the ball valve 434. The wiper edge 425 is pushed into the bottom port 418, through the nozzle channel 417 in the outlet nozzle 404, and out of the outlet port 415. Actuating the wiping edge 425 of the valve lock 401 proximate the end face 413 may clear any effluent that may still be present in the nozzle passage 417, thereby keeping the ball valve 434 clean until the next time the patient wants to actuate and open the valve device 400.

The base 402, ball valve 404, chamber covers 452a-b, and valve lock 401 may all be fabricated from materials similar to the base 202, gate valve 204, and valve cover 207 described herein. Likewise, the sheet 406, valve stem 416, breather filter 438, and wiping edge 425 may also be fabricated from similar materials as the sheet 206, valve stem 216, breather filter 238, and annular seal 221 described herein.

In further alternative embodiments, the valve arrangement may be configured substantially as described above, but without an exhaust port. Whether or not venting is required in some cases may be related to the personal habits of the patient, such as venting frequency and diet. Thus, patients who do not require a vent may prefer the greater control capability provided by a non-vented device. Furthermore, in certain embodiments, it is preferred that the valve stem component not be included, while the remainder of the valve apparatus embodiments are configured in accordance with the embodiments described herein. For some patients, removal of the valve stem component may increase the comfort of the device. Furthermore, since in some embodiments one purpose of the valve stem is to create a functionally independent channel for evacuation of gas and evacuation of liquid/solid waste, it may be desirable to omit the valve stem assembly in a non-venting embodiment.

In view of the above, the improvements discussed herein may facilitate the discharge of fecal matter from the stoma. The materials used in the embodiments may be self-sealing with surfaces within the patient. This function allows the patient to secure the device in place correctly without having to interact with the device, thereby avoiding leakage or other potential errors, and preventing the accidental discharge of faeces from the stoma.

The foregoing is a detailed description of illustrative embodiments of the present disclosure. It is noted that in this specification and the claims appended hereto, the terms "at least one of X, Y and Z" and "one or more of X, Y and Z" and the like should be taken to mean that each item in the connection list may be present in any number (excluding every other item in the list) or in any number in combination with any or all other items in the connection list, where each item may also be present in any number, unless specifically indicated or indicated otherwise. According to this general rule, the phrases in the connection list consisting of X, Y and Z in the above example should all 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; one or more X and one or more Z; and one or more X, one or more Y and one or more Z.

Various modifications and additions may be made without departing from the spirit and scope of the disclosure. The features of each of the embodiments described above may be combined with the features of the other described embodiments as appropriate to provide various combinations of features in the relevant new embodiments. Moreover, while the above describes many independent embodiments, what is described herein is merely illustrative of the application of the principles of the disclosure. Moreover, although particular methods herein may be illustrated and/or described as being performed in a particular order, the order in which aspects of the disclosure are implemented may be highly variable within the scope of conventional techniques. Accordingly, the description is merely illustrative and does not limit the scope of the disclosure.

Exemplary embodiments have been disclosed above and illustrated in the accompanying drawings. Those of skill in the art will appreciate that various modifications, omissions, and additions may be made to the specific disclosure herein without departing from the spirit and scope of the disclosure.

Claims (30)

1. An ostomy valve device, comprising:

An annular support member configured to encircle a stoma of a patient and having an inner side facing the skin and an outer side;

A base member removably mounted in the center of the annular support member, the base member defining first solid and liquid flow paths through the base and second gas discharge flow paths, each flow path having at least one opening on an inner side of the base member;

A valve disposed in the base member, the valve configured to control outflow through the first flow path, the valve having an open position to allow outflow and a closed position to prevent outflow and being operable by a patient between the open position and the closed position;

a valve stem having an inlet and an outlet projecting inwardly from the body member, the valve stem being configured to be received in a stoma of a patient, the valve stem having a length sufficient to extend through a center of the annular support member to position the inlet in the stoma when the base member is mounted to the annular support member, and the outlet being at an opposite end in communication with an opening of the first flow path in the base member; and

A gas permeable filter seal surrounding the valve stem, said gas permeable filter seal covering the opening of the at least one second gas discharge flow path, such that gas can be discharged from the stoma through the second flow path while preventing liquids and solids from entering said second flow path.

2. The ostomy valve device of claim 1, wherein the base member has an inwardly facing concave surface shaped to accommodate a stoma of a patient protruding through a centre of the annular support member.

3. The ostomy valve device according to claim 1 or 2, further comprising means for attaching the annular support member to the skin of the patient, said means being arranged on the skin facing inner side of the annular support member.

4. A stoma valve arrangement according to claim 3, wherein the means for attaching comprises an adhesive material.

5. The ostomy valve device according to any of claims 1-4, wherein the gas permeable filter seal comprises a plurality of filter layers having different pore sizes.

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

7. The ostomy valve device of claim 5, wherein the gas permeable filter seal comprises an annular disc-shaped filter member through which the valve stem passes.

8. The ostomy valve device of any one of claims 1-7, wherein the gas discharge flow path of the base member terminates in at least one gas outlet port opposite the base member interior side, and the base member defines at least one filter chamber in the gas discharge flow path between the at least one interior side opening and the at least one gas outlet port.

9. The ostomy valve device of claim 8, wherein at least one filter chamber comprises an odor absorbing material.

10. An ostomy valve device according to any of claims 1-9, wherein the annular support member and the base member are connected together by means of a press fit.

11. The ostomy valve device of claim 10, wherein the annular support member and the base member each have a face-to-face engagement surface that engages and secures the annular support member and the base member together when pressed together.

12. The ostomy valve device of claim 11, wherein said face-to-face engagement surface is in the shape of a resilient hook.

13. The ostomy valve device of claim 11, wherein said face-to-face engagement surfaces comprise interlocking ribs and grooves.

14. An ostomy valve device according to any of claims 1-9 wherein the annular support member and the base member are engageable by a threaded connection.

15. The ostomy valve device of any one of claims 1-14, further comprising an outlet nozzle terminating a first flow path through the base member and opposite the medial opening.

16. The ostomy valve device of claim 15, further comprising:

a fecal collection bag, wherein the fecal collection bag comprises

A bag;

A coupling sealed to the bag, the coupling having an opening configured to engage the outlet nozzle to receive solids and liquids from the outlet nozzle; and

A first engagement means provided on the connection means; and

A second engagement means provided on the base, the second engagement means being configured to engage with the first engagement means to secure the faeces collection bag to the base member and to engage the outlet nozzle with the opening of the connection means.

17. The ostomy valve device according to any one of claims 1-16, wherein the valve is a gate valve.

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

19. The ostomy valve device of claim 18, wherein the valve comprises a stop locking mechanism engageable with the base member for locking the valve gate in the closed position.

20. The ostomy valve device of claim 19, wherein said detent locking mechanism forms a user operable handle on the valve gate.

21. The ostomy valve device according to claims 1-16, wherein said valve is a ball valve.

22. The ostomy valve device of claim 21, wherein the ball valve comprises a ball member rotatably mounted in a ball recess in the base member for rotation between a closed position in which the nozzle is against the base member and an open position in which the nozzle extends outwardly from the base member.

23. The ostomy valve device of claim 22, wherein the ball valve further comprises a locking plunger configured to slide along the base member and into the ball valve nozzle when in the closed position, thereby preventing rotation of the ball valve to the open position and forcing fecal matter out of the nozzle.

24. A method of patient-controlled discharge of fecal matter from a stoma, comprising:

placing an exhaust valve device in the stoma, the exhaust valve device preventing faeces from exiting the stoma when in a closed position and allowing faeces to exit the stoma when in an open position;

The patient selectively moves the valve means between an open position and a closed position to either expel fecal matter from the stoma or to retain fecal matter within the stoma for later expulsion; and

In both the open and closed position, gas is continuously expelled from the stoma through the valve arrangement.

25. The method of claim 24, further comprising installing or removing the fecal collection container from the valve device when the valve device is in the closed position.

26. The method of claim 25, further comprising opening the valve means after mounting the fecal collection container to the valve means.

27. An ostomy valve device, comprising:

an annular support member configured to encircle a stoma of a patient and having an inner side and an outer side, the inner side facing the skin;

a skin adhesive layer provided on the inner side of the annular support member facing the skin;

a base member detachably mounted on a center of the annular support member, the base member defining a flow passage therethrough, the flow passage having an opening on an inner side of the base member;

A valve disposed in the base member, the valve configured to control outflow through the flow path, the valve having an open position to allow outflow and a closed position to prevent outflow and being operable by a patient between the open position and the closed position;

An outlet nozzle terminating a first path through the base member and disposed opposite the inboard opening that receives outflow through the valve in the open position.

28. The ostomy valve device of claim 27, further comprising:

A fecal collection bag;

A coupling sealed to the bag, the coupling having an opening configured to engage the outlet nozzle to receive solids and liquids from the outlet nozzle;

a first engagement means provided on the connection means; and

A second engagement means provided on the base, the second engagement means being configured to engage with the first engagement means to secure the faeces collection bag to the base member and to engage the outlet nozzle with the opening of the connection means.

29. The ostomy valve device according to claim 27 or 28, wherein the valve is a gate valve comprising a valve gate slidable by the patient between an open position and a closed position.

30. An ostomy valve device according to claim 27 or 28 wherein the valve is a ball valve comprising a ball member and a nozzle member, the ball member being rotatably mounted in a ball recess in the base member for rotation between a closed position in which the nozzle is against the base member and an open position in which the nozzle extends outwardly from the base member.