Inflatable stoma device

Abstract

An ostomy device (100) includes an inflatable member (102) and a tubing (104). The inflatable member defines a bore (106) extending therethrough. The inflatable member is configured to extend around a portion of the intestine (10) proximate a stoma (18). In an operative configuration, the inflatable member is movable between a deflated configuration, in which the stoma is maintained in an open position, and an inflated configuration, in which the inflatable member expands to reduce the size of the aperture itself and close the stoma. The tubing extends from a first end (108) connected to the inflatable member to a second end (110). A passage (112) of the tubing communicates with an interior of the inflatable member such that an inflation fluid is configured to flow through the tubing to move the inflatable member between the deflated configuration and the inflated configuration.

Description

Inventors: Serena SCOTT, Siavash Sam PARKHIDEH, Tracy ANDREOTTI, JenniferLEWITZKY, Paul CARNE, Daniel KEENAN and Brian LUIS Priority Statement

[0001] This invention claims priority to U.S. Provisional Patent Application Serial No. 63 / 597,202, filed November 8, 2023, the disclosure of which is incorporated herein by reference. Technical Field

[0002] The present invention relates to stoma devices, and more particularly to stoma devices comprising an inflatable member of an artificial sphincter configured for stoma management. Background Technology

[0003] Comstomy procedures (e.g., colostomy, ileostomy) are performed on a variety of patients with diseased or damaged intestines, including, for example, colorectal cancer and diverticulosis. Existing commissure procedures involve diverting a portion of the colon (or small intestine) to the abdominal wall for external drainage, where the edges of the colon are sutured to the skin to form an opening called a stoma. Feces are then able to drain from the stoma into a bag or pouch attached to the abdomen. However, commissure procedures often result in postoperative complications and / or patient discomfort, including, for example, leakage, odor, skin irritation due to the attachment of the commissure bag, and social anxiety. Summary of the Invention

[0004] This invention relates to a stoma device comprising an inflatable member defining an orifice extending therethrough, the inflatable member being configured to extend around a portion of the intestine immediately adjacent to the stoma. In an operational configuration, the inflatable member is movable between a deflation configuration and an inflation configuration. In the deflation configuration, the stoma is maintained in an open position, and in the inflation configuration, the inflatable member expands to reduce the size of the orifice and close the stoma. The stoma device also includes tubing extending from a first end connected to the inflatable member to a second end, the tubing having a channel communicating with the interior of the inflatable member such that inflation fluid is configured to flow through the tubing to move the inflatable member between the deflation and inflation configurations.

[0005] In one embodiment, the orifice of the inflatable member is configured to receive a portion of the intestine adjacent to the stoma, such that in an inflatable configuration, the inflatable member expands to apply radially inward pressure around the portion of the inflatable member received therein to close the stoma.

[0006] In one embodiment, the device further includes a bag configured to attach to the abdominal wall around the stoma, such that tubing extends into its interior.

[0007] In one embodiment, the device further includes a valve having a first port extending into the interior of the bag to be coupled to a second end of a piping, and a second port extending along the exterior of the bag to be coupled to an inflation device for supplying inflation fluid to the inflation member; the valve being movable between an open and a closed configuration, wherein in the open configuration a path between the first and second ports is open to allow flow therebetween and to inflate the inflation member, and in the closed configuration a path between the first and second ports is closed.

[0008] In one embodiment, the second end of the piping includes a Luer connector that extends to the outside of the bag and is configured to connect to an inflation device.

[0009] In one embodiment, the device further includes a clamp configured to clamp over the bag and piping to maintain the inflatable member toward its inflatable form.

[0010] In one embodiment, the inflatable member forms a partial ring that extends from a first end to a second end.

[0011] In one embodiment, the inflatable member is configured to be inserted through the stoma and received within a portion of the intestine adjacent to the stoma, such that the orifice of the inflatable member is aligned with the path through the intestine. The device also includes a tubular element extending from a connection end connected to the orifice of the inflatable member to an outlet end to guide the contents of the intestine through the orifice of the inflatable member out of the stoma via the outlet end.

[0012] In one embodiment, the device further includes a secondary control element housed within the tube element and movable between a closed configuration and an open configuration. In the closed configuration, the secondary control element extends across the passage of the tube element to block the flow of intestinal contents therethrough, and in the open configuration, the secondary control element releases the obstruction of the passage of the tube element to allow the intestinal contents to pass through.

[0013] In one embodiment, the secondary control element is configured as a balloon.

[0014] In one embodiment, the device further includes a panel coupled to the outlet end of the tube element; and an expandable spacer configured to extend between the outer surfaces of the panel and the web, wherein, in an operating configuration, the length of the spacer is configured to be adjustable along the length of the tube element to obtain a desired distance between the outer surfaces of the panel and the web.

[0015] In one embodiment, the panel includes a plurality of ports, each of which is configured to be connected to one or more of a plurality of fluid sources to control the inflation of an inflatable member, the movement of a secondary control element between an open and closed configuration, and the adjustment of the length of an expandable spacer.

[0016] Additionally, the present invention relates to a system for draining intestinal contents via a stoma. The system includes a plurality of inflatable members, each configured to be positioned around a portion of the intestine, adjacent to the inner surface of the abdominal wall, within which the stoma is formed. The inflatable members are configured to move from a deflated state to an inflated state, in which the inflatable members expand radially inward to compress the portion of the intestine received therein. The plurality of inflatable members are configured to move sequentially from the deflated state to the inflated state in order from the inflatable member furthest from the stoma to the inflatable member closest to the stoma, such that intestinal contents are pushed toward the stoma through the intestine.

[0017] In one embodiment, the system further includes piping extending from a first end connected to the inflatable member furthest from the stoma to a second end, the piping having a channel communicating with the interior of the inflatable member furthest from the stoma such that inflation fluid is configured to flow through the piping to the inflatable member furthest from the stoma; and a channel connecting a plurality of inflatable members such that, when the inflatable member furthest from the stoma is inflated, inflation fluid is allowed to flow into the next adjacent inflatable member to sequentially inflate the plurality of inflatable members in order from the inflatable member furthest from the stoma to the inflatable member closest to the stoma.

[0018] In one embodiment, the system further includes an artificial sphincter having a generally annular shape to define an opening extending therethrough, the opening being configured to receive a portion of the intestine immediately adjacent to the stoma. In an operational configuration, an inflatable member is movable between a deflation configuration and an inflatable configuration, in which the stoma is maintained in an open position, and in an inflatable configuration, the inflatable member expands to reduce the size of the opening, thereby applying radially inward pressure to the portion of the intestine received therein to close the stoma.

[0019] Additionally, the present invention relates to a method for performing a stoma procedure. The method includes making an incision through the abdominal wall and pulling the distal end of the colon through the incision; pulling the distal end of the colon through the incision and positioning an inflatable member along the outer surface of the abdominal wall and around a portion of the colon; suturing the edge of the colon to the outer surface of the abdominal wall to form a stoma, such that the inflatable member is fixed between the outer surface of the abdominal wall and the distal end of the colon; and moving the inflatable member between a deflated state and an inflated state to open and close the stoma as needed.

[0020] In one embodiment, moving the inflatable member between a deflated state and an inflated state includes supplying inflatable fluid to and from the inflatable member via piping extending therefrom.

[0021] In one embodiment, the method further includes attaching an ostomy bag to the outer surface of the abdominal wall such that when the stoma is opened, the contents of the intestine flow from the stoma into the ostomy bag.

[0022] In one embodiment, attaching the ostomy bag includes connecting a first port of a valve of the ostomy bag to an inflatable member and a second port of a valve to an inflation device to provide inflation fluid to the inflatable member. The valve is movable between an open configuration and a closed configuration, in which flow between the inflatable member and the inflation device is permitted, and in a closed configuration, flow between the inflatable member and the inflation device is impeded.

[0023] In one embodiment, the inflatable member is positioned along the outer surface of the skin by inserting the base into an opening in the abdominal wall formed by an incision, and the inflatable member is housed within a head that is releasably coupled to the base. Attached Figure Description

[0024] Figure 1 A perspective view of an ostomy system according to an exemplary embodiment of the present invention is shown.

[0025] Figure 2 It shows that according to Figure 1 A three-dimensional cross-sectional view of the stoma system.

[0026] Figure 3 It shows that according to Figure 1 A plan view of the stoma system, in which its inflatable components are in a deflated state to open the stoma.

[0027] Figure 4 It shows that according to Figure 1 A plan view of the stoma system, in which the inflatable component is in an inflatable state to close the stoma.

[0028] Figure 5 It shows Figure 1 A plan view of the stoma system, which includes a syringe.

[0029] Figure 6 It shows Figure 1 A floor plan of the stoma system, which includes a manual pump.

[0030] Figure 7 A plan view of an ostomy system according to another exemplary embodiment is shown, which includes a clamp.

[0031] Figure 8 A plan view of an ostomy system according to yet another exemplary embodiment of the present invention is shown.

[0032] Figure 9A plan view of a stoma device configured to be compatible with loop stoma surgery is shown according to another exemplary embodiment, wherein the stoma device is in a deflation configuration to open the stoma.

[0033] Figure 10 It shows Figure 8 A plan view of the stoma device, which is in an inflated state to close the stoma.

[0034] Figure 11 A side view of an ostomy system including an ostomy device is shown according to another exemplary embodiment of the present invention.

[0035] Figure 12 It shows that according to Figure 10 A cross-sectional side view of the ostomy device.

[0036] Figure 13 It shows that according to Figure 10 A three-dimensional view of the base of the ostomy device.

[0037] Figure 14 It shows that according to Figure 10 A side view of the base of the stoma device.

[0038] Figure 15 It shows that according to Figure 10 A side view of the head of the stoma device.

[0039] Figure 16 It shows that according to Figure 10 A top view of the head of the stoma device.

[0040] Figure 17 It shows that according to Figure 10 A three-dimensional view of the head and irrigation system of the stoma device.

[0041] Figure 18 It shows that according to Figure 10 An exploded view of the irrigation system of the stoma device.

[0042] Figure 19 A side view of an ostomy system according to another exemplary embodiment of the present invention is shown.

[0043] Figure 20 It shows that according to Figure 18 A cross-sectional view of the stoma device of the system, in the venting state with the stoma open.

[0044] Figure 21 It shows that according to Figure 19 A cross-sectional view of the stoma device in its inflated state during stoma closure.

[0045] Figure 22A plan view of an ostomy apparatus according to an alternative embodiment of the invention is shown, wherein the inflatable member includes a plurality of leaflets in a deflated state, thereby opening the ostomy.

[0046] Figure 23 It shows that according to Figure 21 The plan view of the stoma device in the embodiment shows the leaflets in an inflated state, causing the stoma to close.

[0047] Figure 24 A cross-sectional side view of an ostomy system according to another exemplary embodiment of the present invention is shown.

[0048] Figure 25 An example of another exemplary embodiment is shown. Figure 23 A cross-sectional side view of the stoma system.

[0049] Figure 26 It shows that according to Figure 24 A plan view of the panel of the stoma system.

[0050] Figure 27 An illustration is shown according to another embodiment Figure 24 A side view of the stoma system.

[0051] Figure 28 An example according to yet another embodiment is shown. Figure 24 A side view of the stoma system.

[0052] Figure 29 A side view of an ostomy system according to another exemplary embodiment of the present invention is shown.

[0053] Figure 30 A cross-sectional side view of an ostomy system according to yet another exemplary embodiment of the present invention is shown. Detailed Implementation

[0054] The invention can be further understood with reference to the following description and accompanying drawings, wherein like elements are designated by like reference numerals. The present invention relates to an ostomy system, and more particularly to an ostomy device comprising an inflatable member configured to act as an artificial sphincter to control the flow of feces from the colon through the stoma and out of the patient's body.

[0055] Exemplary embodiments of the present invention include a stoma device comprising an inflatable member implantable adjacent to a stoma (e.g., an opening in the abdominal wall connected to the end of an organ, such as the small intestine or colon) to act as an artificial sphincter. Specifically, the inflatable member is movable between a deflated mode and an inflated mode, in which the stoma is open to allow passage of waste, and in an inflated mode, the stoma is closed to prevent passage of waste. Although exemplary embodiments may specifically describe colostomy in which the end of the colon is attached to the abdominal wall, those skilled in the art will understand that the systems and methods of the present invention can be used for any stoma procedure, including ileostomy, in which the end of the small intestine is diverted to the abdominal wall.

[0056] like Figures 1 to 4 As shown, the stoma system 100 according to an exemplary embodiment of the present invention includes an inflatable member 102 configured to be positioned around the intestine 10 (e.g., colon) along the exterior of the abdominal wall 12 during surgical formation of the stoma 18. According to an exemplary embodiment, as... Figures 1 to 2 As shown, the distal end 14 of the intestine 10 passes through an opening in the abdominal wall 12 and is secured (e.g., sutured) to the skin 16 of the abdominal wall 12 on the inflatable member 102, such that the inflatable member 102 is securely implanted between the intestinal wall and the outer surface of the skin 16. The system 100 includes a conduit 104 extending from the inflatable member 102, which can be deployed via the conduit 104 in a deflated configuration with the stoma open. Figure 3 (as shown) and the filling pattern of the closed stoma ( Figure 4 The intestines move between the two sides (as shown) to act as artificial sphincters to control the flow of excrement (e.g., feces and gas) from the intestines.

[0057] In one exemplary embodiment, the inflatable member 102 has a generally annular shape, wherein the ends of the tubular elements are connected to each other to form a generally hollow circular ring, which allows the inflatable member 102 to be positioned around the intestinal wall, immediately adjacent to its ends, as discussed above. Specifically, the inflatable member 102 of the exemplary embodiment is generally annular or donut-shaped, thereby defining an opening 106 extending therethrough. In one exemplary embodiment, the opening 106 is aligned with an opening through the abdominal wall to which the end of the intestine is connected. The inflatable member 102 can be formed from a variety of biocompatible polymers that expand and / or enlarge upon filling, for example, with an inflatable fluid (e.g., gas or liquid). For example, the inflatable member 102 can be formed from a silicone elastomer or any other suitable material, as will be understood by those skilled in the art.

[0058] In such Figure 3 In the venting configuration shown, the orifice 106 substantially corresponds to the cross-sectional area of ​​the intestine, allowing feces to pass through it when the stoma is opened. Figure 4In the shown expansion configuration, the diameter of the donut-shaped circular pipe forming the inflatable member 102 is increased, thereby reducing the diameter of the orifice 106.

[0059] As the inflatable member 102 moves toward the inflatable position, it compresses the intestinal wall and extends radially inward around the intestinal wall, thereby closing the stoma and preventing excrement from flowing through it. Thus, the inflatable member 102 acts as an artificial sphincter to open and close the stoma as needed. Although exemplary embodiments show and describe a tubular element that forms the hollow tubular annulus of the inflatable member 102 with a generally circular cross-section, the tubular element of the inflatable member 102 can have any of a variety of shapes, as long as the inflatable member 102 is configured to move between a deflated and inflated position to open and close the stoma as needed.

[0060] Tubing 104 extends longitudinally from a first end 108 connected to the inflatable member 102 to a second end 110 connectable to a means for providing inflatable fluid to the inflatable member 102, such as a syringe. Tubing 104 includes a channel 112 extending therethrough, wherein channel 112 communicates with the interior of the inflatable member 102, such that inflatable fluid is provided to the interior of the inflatable member 102 via tubing 104. In an operational configuration in which the inflatable member 102 is implanted between the intestinal wall and the outer surface of the skin, tubing 104 extends along the exterior of the skin from the stoma. In an exemplary embodiment, tubing 104 may be flexible, allowing it to be connected to a syringe or other inflatable device as needed.

[0061] like Figure 5 The system 100 of the illustrated embodiment also includes an ostomy bag 114 configured to attach to a stoma (e.g., to a patient's skin) such that feces passing through the stoma are received and collected within the bag 114. In one exemplary embodiment, the bag 114 includes a valve 116 connected to the bag 114. In one exemplary embodiment, the valve 116 includes a knob 122 extending from the outside of the bag 114, and a first port 118 extending into the inside of the bag 114 and a second port 120 extending from the outside of the bag 114.

[0062] Knob 122 is configured to open and close the communication between the first port 118 and the second port 120. In one exemplary embodiment, the first port 118 is configured to be connected to a second end 110 of tubing 104 via, for example, a Luer connector. The second port 120 is configured to be connected to an inflation device 124, such as, for example, a syringe 126. Figure 6As shown. The second port 120 can be connected to the syringe 126 via, for example, a Luer connector. Although the first port 118 and the second port 120 are described as being connectable to the tubing 104 and the syringe 126 respectively, those skilled in the art will understand that the first and second ports 118, 120 can include any of a variety of connection mechanisms, including, for example, a friction fit. In one exemplary embodiment, the valve 116 can be permanently connected to the bag 114, but can also be easily connected to and disconnected from the inflation device 124 and the tubing 104.

[0063] In one exemplary embodiment, valve 116 is movable between an open and a closed state when inflation fluid is supplied to inflatable member 102 via syringe 126, in which fluid is prevented from passing between syringe 126 and tubing 104. To move inflatable member 102 from a deflated state to an inflated state, knob 122 is rotated to move valve 116 from a closed state to an open state. Subsequently, syringe 126 connected to second port 120 can be pressed to inflate inflatable member 102.

[0064] Once the inflatable member 102 has been inflated as needed, valve 116 can move from an open position to a closed position to seal the inflation fluid (e.g., air or water) therein. Those skilled in the art will understand that syringe 126 is configured to supply and remove inflation fluid from the inflatable member 102 as needed. For example, syringe 126 can supply inflation fluid to the inflatable member 102 to inflate it and close the stoma. When it is necessary to open the stoma, valve 116 moves to an open position and the syringe is operated to remove the inflation fluid from the inflatable member 102, moving the inflatable member 102 from an inflated position to a deflated position.

[0065] In one exemplary embodiment, syringe 126 is a locking syringe that includes a locking mechanism configured to lock syringe 126 in any of a variety of positions to hold system 100 in a desired pressurized configuration until valve 116 moves to a closed configuration. In an alternative embodiment, system 100 includes an insertion tubing 104 and a check valve at, for example, a Luer connector located at a second end 110 of tubing 104. As those skilled in the art will understand, the check valve helps control sudden pressure changes when syringe 126 is connected to and / or disconnected from the second port 120. The check valve also reduces and / or prevents any unintended backflow due to internal body pressure, which could cause unintended deflation of the inflatable member 102 during normal use.

[0066] In another embodiment, such as Figure 6 As shown, the inflation device 124 includes a manual pump 128, which includes a pressure gauge 130. The manual pump 128 can be connected to the valve 116 of the bag 114 in a manner substantially similar to the connection of the syringe 126 described above. In one exemplary embodiment, the manual pump 128 includes a ball 132 configured to squeeze to provide fluid to the inflatable member 102 to move the inflatable member 102 from a deflated state to an inflated state; and a knob 134 configured to operate to release air when the inflatable member 102 is moved from an inflated state to a deflated state.

[0067] Additionally, pressure gauge 130 can be configured to automatically release pressure at a threshold pressure (e.g., the maximum pressure considered safe for the stoma or any component of system 100, or a pressure set by the user). The pressure gauge may include markings indicating a target inflation pressure for achieving a tight seal of the stoma without over-inflating the inflatable member 102. According to one exemplary embodiment, in some cases, the patient can open valve 116 to open the stoma when the contents of the intestine (i.e., feces) are needed. This can be done several minutes before the patient prepares to empty bag 114, allowing sufficient time for feces to flow into bag 114.

[0068] Although exemplary embodiments of system 100 are shown to include a bag 114, those skilled in the art will understand that system 100 can be used alone as needed, without the bag 114. When used alone, tubing 104 can be directly connected to an inflation device 124 (e.g., a syringe, a manual pump) to deflate / inflate the inflatable member 102 as needed. In one exemplary embodiment, the inflatable member 102 can be maintained in an inflated state to close the stoma until the patient is ready to use the toilet.

[0069] The inflatable member 102 can then be moved toward a deflated configuration to open the stoma, allowing feces to drain directly from the stoma into a toilet or other disposal system. The bag 114 can be used as a backup to reduce the chance of leakage. Those skilled in the art will also understand that although system 100 has been specifically described with respect to syringe 126 and / or manual pump 128, the inflation device 124, which can be connected to piping 104 to supply inflation fluid to and / or from the inflatable member 102, may include any of a variety of devices capable of inflating and deflating the inflatable member 102 as needed.

[0070] According to an exemplary method utilizing system 100, a portion of a target organ (e.g., colon or ileum) is passed through an incision in the abdominal wall. An inflatable member 102 is positioned around that portion of the target organ (e.g., colon) along the outer surface of the skin of the abdominal wall. The edge of the portion of the target organ can then be sutured to the skin to secure the inflatable member 102 between the wall of the target organ and the skin to form a stoma through which excrement can pass. The edge of the target organ can be sutured to the skin such that a tubing 104 extends out of the stoma, making it accessible to a user of system 100 (e.g., a patient). As described above, system 100 can be used alone or in combination with bag 114 as a backup to prevent leakage.

[0071] When system 100 is not used with bag 114, tubing 104 can be connected to an inflation device, such as, for example, a syringe or a manual pump. Valve 116 can be directly connected to tubing 104 to maintain system inflation. The syringe can be connected to tubing 104 or valve 116, for example, via a Luer connector. As described above, the inflation device can be used to move the inflatable member 102 between a deflation mode and an inflation mode to open and close the stoma, respectively. The inflation device supplies fluid (e.g., air or water) to the inflatable member 102 to expand the inflatable member 102, thereby reducing the size of the orifice 106 defined thereby.

[0072] When the inflatable member 102 moves from the deflated state to the inflated state, it expands and presses against a portion of the target organ, extending radially inward around that portion to close the stoma. The inflatable member 102 moves from the inflated state to the deflated state by extracting air from itself, thereby releasing radially inward pressure around the end of the target organ to allow the stoma to open.

[0073] The bag 114 can be positioned on the stoma in a manner substantially similar to a conventional ostomy bag. However, as described above, the bag 114 includes a valve 116. In one exemplary embodiment, a first port 118 of the valve 116, extending along the interior of the bag 114, can be connected to a second end 110 of the piping 104, while a second port 120 of the valve 116, extending from the exterior of the bag 114, is connected to an inflation device 124 (e.g., a syringe 126 or a manual pump 128). The valve 116 can be opened using a knob 122, thereby allowing fluid to pass between the inflation device 124 and the inflatable member 102.

[0074] When valve 116 is in the open position, inflation device 124 supplies fluid to inflatable member 102 to move it into an inflatable state. Inflatable member 102 can be maintained in the inflatable state, thereby closing the stoma by closing valve 116. When it is necessary to allow excrement to pass through the stoma, valve 116 moves to the open position, and inflation device 124 removes fluid from inflatable member 102, thereby opening the stoma to allow feces to flow through and be collected in bag 114. Those skilled in the art will understand that, if necessary, inflation device 124 can be disconnected from valve 116 when valve 116 is in the closed position.

[0075] When the user does not wish to use bag 114, the stoma can remain in the closed position (inflatable member 102 in the inflatable state) until the patient has access to the toilet and / or when it is necessary to empty excrement from the target organ. Inflatable member 102 can then be moved to the deflated state to open the stoma. Feces can then be released directly into, for example, a toilet or other container.

[0076] Except for the differences described below, according to another exemplary embodiment, system 100A, such as Figure 7 As shown, it is substantially similar to system 100. System 100A includes an inflatable member 102A configured to move between a deflation mode and an inflatable mode to open and close the stoma via a tubing 104A configured to connect to an inflatable device (e.g., a syringe). Similar to system 100, system 100A may also include a stoma bag 114A. However, bag 114A does not include a valve. When bag 114A is in the operational position on the stoma, a first end 108A of tubing 104A is contained within bag 114A. A second end 110A of tubing 104A is configured to extend to the outside of bag 114A such that its Luer connector 111A can be connected to an inflatable device. When the inflatable member 102A is in the inflatable mode, clamp 116A can be used to clamp both bag 114A and closing tubing 104A to keep the stoma closed until the contents of the colon need to be emptied.

[0077] Except for the differences described below, according to yet another exemplary embodiment, system 200, such as Figure 8As shown, it is substantially similar to systems 100 and 100A. Similar to system 100, system 200 includes an inflatable member 202 configured to be positioned around the intestine along the outer surface of the abdominal wall (e.g., skin 26), such that moving the inflatable member 202 between a deflated and an inflated configuration can open and close the stoma 28, respectively. However, the inflatable member 202 forms an incomplete and / or partial ring extending from a first end 223 to a second end 225, rather than forming a full ring, as described with respect to inflatable member 102. In other words, the inflatable member 202 may be substantially C-shaped, with its size set to extend around the periphery of the intestine. System 200 includes a pair of tubes 204A, 204B, instead of a single tube, each of which extends from a corresponding one of the first and second ends 223, 225 to the outside of stoma 28, allowing an inflatable fluid (e.g., gas or liquid) to be supplied to the inflatable member 202 via one or more of the tubes 204A, 204B. In one embodiment, the pair of tubes 204A, 204B may be connected to each other via a connector 227 that also extends to the outside of stoma 28. Those skilled in the art will understand that system 200 allows for simple, non-invasive removal if necessary. In particular, one or both of the tubes 204A, 204B may be cut along a cut line 229, allowing the inflatable member 202 to be pulled out or withdrawn from stoma 28.

[0078] Except for the differences described below, according to yet another exemplary embodiment, system 300, such as Figures 9 to 10 As shown, it is substantially similar to systems 100 and 200. Unlike the single inflatable member included in systems 100 and 200, system 300 includes a stoma device 301 comprising a pair of inflatable members 302A and 302B, making system 300 compatible with loop stoma surgery, in which a loop of the colon (or other organ) is pulled through an incision formed in the abdominal wall. The loop is opened and its edges are sutured to the skin to form a stoma with two openings. Each of the inflatable members 302A and 302B is substantially similar to the inflatable member 102 as described above and can be implanted into the skin while the edges of the target organ are sutured to the skin, and fixed in a suitable position around the corresponding opening of the stoma.

[0079] Inflatable components 302A and 302B can be connected to each other via connecting portion 303, so that both inflatable components 302A and 302B can be vented via a single piping element 304 (see [link]). Figure 9 ) and swelling (see Figure 10However, in alternative embodiments, inflatable components 302A and 302B may be separable from each other and supplied by separate piping elements, as will be understood by those skilled in the art. It will also be understood by those skilled in the art that, similar to the systems described above, system 300 may be used with an ostomy bag in a manner substantially similar to that of system 100 described above, if desired.

[0080] like Figures 11 to 17 As shown, except for the differences described below, system 400 according to another exemplary embodiment is substantially similar to system 100 described above. System 400 includes an inflatable member 402 (e.g., an annular member) configured to open and close the stoma as needed. However, as Figures 11 to 12 As shown, an inflatable member 402 is housed within a head 436, which is releasably coupled to a base 438 configured to be implanted within an opening in the abdominal wall surrounding a portion of the target organ. When the system 400 is in an operational configuration, the base is implanted within the abdominal opening, and the head 436 extends along the outer surface of the skin.

[0081] In this embodiment, an inflatable member 402 is housed within a head 436, which, in an operational configuration, extends along the exterior of the abdominal wall surrounding a portion of the target organ extending from a base 438. Thus, when the edge of the distal end of the target organ is sutured to the skin to form a stoma, the inflatable member 402 within the head 436 is secured between the skin and the exterior of the target organ. The inflatable member 402 is movable between a deflation configuration and an inflation configuration to open and close the stoma as needed to empty the intestine. In an exemplary embodiment, the head 436 is connected to an injection system 440 (e.g., an irrigation system) that communicates with the inflatable member 402 to allow the inflatable member 402 to move between a deflation configuration and an inflation configuration.

[0082] Those skilled in the art will understand that the base 438 can be implanted within the abdominal wall to provide support to the target organ and the abdominal wall, thereby reducing the risk of hernia. The head 436 remains outside the abdominal wall, allowing the head 436 to be detached from the base 438 in case of, for example, injection system failure, leakage or rupture of the inflatable member 402, or other failures that inevitably occur with prolonged use of the inflatable member 402, so that the head 436 and / or the inflatable member 402 can be replaced.

[0083] like Figures 13 to 14As shown, the base 438 includes a tubular body 442 extending from a first end 444 to a second end 446. In this embodiment, the tubular body 442 is formed of a biocompatible material (e.g., titanium) having a mesh-like morphology. The first end 444 includes a first flange 448, while the second end 446 includes a second flange 450. The length L of the tubular body 442 is configured to correspond to the length of the opening, which extends from its inner surface through the abdominal wall to its outer surface (e.g., skin).

[0084] In other words, the length L of the tubular body 442 corresponds to the width of the abdominal wall, that is, the distance between the inner and outer surfaces of the abdominal wall. A first flange 448 engages the inner surface of the abdominal wall, while a second flange 450 engages the outer surface, thereby securing the tubular body 442 of the base 438 within the opening. In this embodiment, the diameter D of one of the first flange 448 and the second flange 450 corresponds to the desired size of the stoma, depending on, for example, the anatomical structures involved in the stoma surgery. For example, the diameter of the tubular body 442 may substantially correspond to the diameter of the target portion of the intestine (e.g., colon, ileum) in the stoma surgery.

[0085] In one exemplary embodiment, the first flange 448 and the second flange 450 have the same size and shape. However, those skilled in the art will understand that each of the first flange 448 and the second flange 450 may have any of a variety of sizes and shapes, as long as the first flange 448 and the second flange 450 are sized and shaped to engage the inner and outer surfaces of the abdominal wall, respectively, to secure the tubular body 442 within the opening extending through it.

[0086] like Figure 15 As shown, the head 436 includes a housing 452 configured to receive an inflatable member 402 and a plate 454 connected to the housing 452 via a reduced-diameter portion to form a stepped groove 456 around the exterior of the head 436. The housing 452 is formed via an outer wall 458, a first surface 460 located at a first end 462 of the outer wall 458, and a second surface 464 located at a second end 466 of the outer wall 458. The first surface 460 may include features facilitating releasable engagement with the base 438.

[0087] For example, in this embodiment, the first surface 460 and the base 438, and the second flange 450, include corresponding engagement features. The outer wall 458, the first surface 460, and the second surface 464 define a cavity 468 in which the inflatable member 402 is received. In an exemplary embodiment, the size and shape of the first surface 460 and the second surface 464 substantially correspond to the second flange 450, including holes 461, 465 extending therethrough, such that a portion of a target organ (e.g., colon, ileum, etc.) passing through the tubular body 442 can also pass through the holes 461, 465 of the first surface 460 and the second surface 464 of the housing 452 and the hole 406 of the inflatable member 402 received therein.

[0088] like Figure 16 The plate 454 shown includes a hole 455 extending through it, which aligns with holes 461, 465 of the housing 452 to allow a portion of a target organ to pass through it. An exemplary embodiment of the plate 454 also includes a plurality of suture holes 470 along its periphery, configured to allow the end of the target organ and / or skin to be sutured thereto. Those skilled in the art will understand that a stepped groove 456 immediately adjacent to the plate 454 is configured to allow, for example, surgical manipulation of the head 436 and / or placement of an ostomy bag (not shown) or other accessories that can be used in conjunction with ostomy procedures. The height H of the stepped groove, for example, the distance between the plate 454 and the second surface 464, can be selected to, for example, facilitate attachment to an ostomy bag or other accessories.

[0089] like Figures 17 to 18 As shown, the injection system 440 functions substantially similarly to a syringe and includes a hollow tube 472 (e.g., circular) connected to a head 436, which communicates with an inflatable member 402 housed therein via a plurality of hollow legs 474 welded to a housing 452. A first portion 472A of the hollow tube 472 is filled with a liquid (e.g., water) that can be pressurized into the inflatable member 402, while a second portion 472B of the hollow circular tube contains a plunger 476 that can slide through the hollow tube 472 to pressurize the inflatable member 402.

[0090] In one exemplary embodiment, a first portion 472A of the hollow tube 472 is connected to a leg 474 of the head 436 and is also sealed within the inflatable member 402, such that when the plunger 476 moves from the open position toward the closed position, the plunger 476 pushes fluid through the leg 474 to pressurize the inflatable member 402. The second portion 472B may include a guide rail 478 along which a handle 480 configured to move the plunger 476 between the open and closed positions can slide.

[0091] Similar to inflatable member 102, inflatable member 402 expands upon inflation, thereby reducing the size of orifice 406 to radially inward push the portion of the target organ received therein to close the stoma. When it is necessary to open the stoma, plunger 476 can move toward the closed position, which depressurizes inflatable member 402, thereby releasing the radially inward pressure on the target organ and allowing the stoma to open.

[0092] The head 436 and / or injection system 440 can be formed of any suitable material, such as metal (e.g., stainless steel), configured to support the expected pressure and increase service life. Similar to system 100, the inflatable member 402 can be formed of an elastomeric material, such as, for example, a silicone elastomer.

[0093] According to an exemplary method of using system 400 for a stoma procedure, an incision is made in the abdominal wall to form an opening between an inner and outer surface of the abdominal wall. A base 438 is positioned within the opening in the abdominal wall such that a first flange 448 engages the inner surface of the abdominal wall, and a second flange 450 engages the outer surface of the abdominal wall (i.e., the skin), such that the base 438 is secured within the opening, and a head 436 extends along the outer surface of the skin. The distal end of a target organ (e.g., the colon) is then pulled through the tubular body 442 of the base 438, through the head 436, and through a hole 406 in an inflatable member 402 housed therein. The edges of the colon and skin are sutured to suture holes 470 in the plate 454 of the head 436 to form a stoma.

[0094] The inflatable member 402 can be moved from a deflated state to an inflatable state to close the stoma until bowel emptying is required. To inflate the inflatable member 402, the handle 480 of the injection system 440 slides along the hollow tube 472 from an open position to a closed position, causing the plunger 476 to move within it in a first direction. The movement of the plunger within the hollow tube 472 pressurizes the fluid within the first portion 472A on the inflatable member 402, causing it to expand and exert radially inward pressure on a portion of the colon around which the inflatable member 402 extends, thereby closing the stoma.

[0095] When bowel emptying is required, the handle 480 moves from the closed position to the open position, causing the plunger to slide within the hollow tube 472 in a second direction opposite to the first direction to depressurize the inflatable member 402. When the inflatable member 402 deflates, radially inward pressure on the colon is released, thereby opening the stoma. Those skilled in the art will understand that the system 400 can be used with or without an ostomy bag. When used with an ostomy bag, the bag is connected to the head 436 by, for example, engaging a portion of the bag with a stepped groove 456, so that feces from the intestine are collected in the bag. Those skilled in the art will understand that the inflatable member 402 can be moved between a deflated and inflated state via the injection system 440 to open and close the stoma as needed.

[0096] like Figures 19 to 21 As shown, except for the differences described below, system 500 according to another exemplary embodiment of the present invention is substantially similar to system 400 described above. System 500 includes a stoma device 501, which includes a base 538 and an inflatable member 502. The base 538 is configured to be implanted within an opening extending through the patient's abdominal wall during stoma formation, and the inflatable member 502 is configured to be positioned adjacent to the stoma to open and close the stoma as needed. However, in this embodiment, the inflatable member 502 is received within the base 538 such that the inflatable member 502 is received within the patient to form an artificial sphincter for the stoma. In other words, as described in more detail below, in this embodiment, the inflatable member 502 does not extend around the outer wall of the target organ, but is received within and / or in the anterior portion of the distal end 50 of the target organ (e.g., the colon).

[0097] The base 538 may be substantially similar to the base 438 of system 400, including a tubular body 542 extending from a first end 544 to a second end 546. However, the base 538 may be formed of a soft polymer that is easily sutured or otherwise adhered to the skin 56 and the tissue of the target organ to form a bridging member between the end 50 of the target organ and the skin 56 surrounding the opening in the abdominal wall. In one exemplary embodiment, the base 538 is formed of a biocompatible mesh or bioadhesive that enables inward growth and fusion of tissue.

[0098] Similar to base 438, in one exemplary embodiment, base 538 includes a flange 550 at a second end of tubular body 542. The flange 550 is configured to attach to and / or suture to skin 56 after the stoma device 501 is inserted into an opening in the abdominal wall. In one exemplary embodiment, the distal end 50 of the target organ may be attached to a portion of tubular body 542, such that attaching or suturing base 538 to skin 56 forms a stoma. In another embodiment, a portion of the target organ is pulled through tubular body 542, such that the edge of the target organ wall may be sutured together with flange 550 or otherwise attached to skin 56.

[0099] As discussed above, the inflatable member 502 is received within the tubular body 542 and can be in a deflated state ( Figure 20 (as shown) and inflation pattern ( Figure 21 The inflatable member 502 moves between the two configurations (shown in the diagram). In the deflation configuration, the stoma opens, and in the inflation configuration, the inflatable member 502 inflates, thereby expanding and closing the stoma. Similar to the inflatable members 102 to 402 described above, the inflatable member 502 in this embodiment is substantially annular, defining an orifice 506 through which feces are allowed to pass from the target organ through the orifice 506 and the stoma when the inflatable member 502 is in the deflation configuration. In the deflation configuration, the inflatable member 502 expands, thereby reducing the size of the orifice 506 and preventing feces and other excrement from passing through it. In an exemplary embodiment, the outermost edge of the inflatable member 502 is fixed to the interior 543 of the tubular body 542, such that the inflatable member 502 maintains its desired position adjacent to the stoma when implanted in the body.

[0100] Similar to the system described above, the inflatable member 502 can move between a deflated and inflated configuration via a conduit 504 extending from it to the patient's body. The conduit 504 extends from a first end 508 connected to the inflatable member 502 to a second end 510 extending outside the patient's body to a position accessible to the patient. In this embodiment, the second end 510 includes a control valve 516 that controls the flow to and / or from an inflating device (e.g., a syringe) configured to supply inflating fluid (e.g., gas or liquid) to the inflatable member 502 as needed.

[0101] In one exemplary embodiment, the stoma device 501 further includes a cylindrical disk 536 extending around a portion of the base 538, in which an inflatable member 502 is received to provide radially inward pressure to the inflatable member 502 such that when the inflatable member 502 moves from a deflated state to an inflated state, the inflatable member 502 expands radially inward, thereby reducing the size of the orifice 506 extending through it to move the stoma to a closed position.

[0102] Although the exemplary embodiments show and describe inflatable members 102 to 502 as generally annular, those skilled in the art will understand that inflatable members 102, 502 can take various shapes and / or forms, as long as movement between a deflation configuration and an inflation configuration allows for opening and closing of the stoma. For example, in one exemplary embodiment, such as Figures 22 to 23 As shown, the stoma device 601 can be substantially similar to the stoma device 501 described above, including an inflatable member 602 received within the base 638. However, the inflatable member 602 can be composed of a plurality of leaflets 603 instead of being annular, each of the plurality of leaflets 603 being attached to the interior 643 of the base 538 and movable between a deflation mode and an inflation mode, in which an orifice 606 is defined between the leaflets 603 to open the stoma, and in the inflation mode, the leaflets 603 inflate to expand, thereby reducing the size of the orifice 606 to close the stoma.

[0103] like Figure 24 As shown, except for the differences described below, system 700 according to another exemplary embodiment is substantially similar to system 500 described above. System 700 includes a stoma device 701, which includes an inflatable member 702 configured to open and close a stoma 78 as needed. However, during stoma formation, stoma device 701 is configured to be inserted through stoma 78 and into the interior of a target organ 70 (e.g., colon), such that the inflatable member 702 is positioned near an abdominal wall 72 through which the stoma 78 is formed; and a tubular element 782 extending from a through-hole 706 (e.g., channel) of the inflatable member 702 extends out of the stoma to the outside. Thus, when the stoma 78 is open, feces can be discharged from the target organ 70 through the through-hole 706 and the tubular element 782.

[0104] In one exemplary embodiment, the inflatable member 702 may be substantially similar to the inflatable members 102 to 602 described above, and the inflatable member 702 is movable between a deflation mode and an inflation mode. In the deflation mode, the stoma is in an open position, allowing feces to pass through the through-hole 706 from the target organ and exit the stoma for direct drainage, for example, into a toilet or collected in a bag or other container. In the inflation mode, an inflation fluid (e.g., gas, liquid) is received within the inflatable member 702, causing the inflatable member to expand to reduce the size of the through-hole 706 toward the closed position of the stoma. Therefore, in this inflation mode, feces are prevented from passing through the through-hole 706.

[0105] In one exemplary embodiment, the through-hole 706 tapers from a first end 744 toward a second end 746, such that feces are directed toward a tubular element 782 extending from the second end 746. The tubular element 782 extends from the second end 746 of the through-hole 706 of the inflatable member 702 to an outlet end 784, which, in an operational configuration where the inflatable member is implanted in the colon, extends externally as described above.

[0106] According to another exemplary embodiment, such as Figures 25 to 26 As shown, the stoma device 701 also includes a generally planar panel 754 extending around the outlet end 784 of the tubular element 782, such that a through-hole 755 of the panel 754 is aligned with the outlet end 784 of the tubular element 782. A spacer 752 extends from a surface 756 of the panel 754 facing the stoma 78, such that in an operational configuration, the spacer 752 abuts against the external skin 76 of the abdominal wall 72 and extends between the skin 76 and the panel 754 to maintain a distance between the panel 754 and the skin 76. In an exemplary embodiment, the spacer 752 may expand along the length of the tubular element 782, allowing the distance between the panel 754 and the skin to be adjusted as needed. The length of the spacer 752 can be increased by supplying it with inflatable fluid and decreased by releasing it from inflatable fluid. Those skilled in the art will understand that the spacer 752 also helps to maintain the inflatable member 702 in a desired position along the target organ, thereby preventing the inflatable member 702 from migrating along it.

[0107] In one exemplary embodiment, the stoma device 701 includes a secondary drainage control element 786 that extends across its channel into the tube element 782 to provide additional leakage protection. The secondary control element 786 is movable between a closed configuration and an open configuration. In the closed configuration, the secondary control element 786 extends across and blocks the channel of the tube element 782 to prevent leakage of excrement from the tube element 782. In the open configuration, the secondary control element 786 releases the obstruction of the channel of the tube element 782, allowing feces received within the channel of the tube element 782 to drain through it toward its outlet end 784 and out of the body. The secondary control element 786 may be particularly useful when feces have been expelled from the stoma but remain within the tube element 782. The secondary control element 786 prevents feces from leaking out of the tube element 782.

[0108] Those skilled in the art will understand that the secondary control element 786 can have any of a variety of forms, as long as it is movable between an open and a closed form, as discussed above. In one example, the secondary control element 786 can be a balloon that expands to fill the channel of the tubular element 782 when it moves from an open to a closed form. In another example, the secondary control element 786 can be configured as a flap that is movably connected to the interior of the tubular element 782.

[0109] In one exemplary embodiment, the stoma device 701 further includes an irrigation channel 788 that extends along the interior of the tubular element 782 and into a through-hole 706 of the inflatable member 702 to provide irrigation to the through-hole 706 and the portion of the colon in which the inflatable member 702 is received.

[0110] In this embodiment, panel 754 includes a plurality of ports 790, each of which is configured to be connected to one or more of a plurality of fluid (e.g., air or water) sources and / or pump devices, actuators, or other control devices for controlling, for example, movement of the inflatable member 702 between a deflation and inflation configuration, movement of a secondary control element 786 between an open and closed configuration, adjustment of the spacer 752, and irrigation via the irrigation channel 788. In an exemplary embodiment, the fluid source / pump device may include a syringe or a manual pump. For example, a first port 790A may be in communication with the inflatable member 702 and may be connected to, for example, a syringe or a manual pump, such that the inflatable member 702 may be moved between a deflation and inflation configuration to open and close the stoma as needed.

[0111] The second port 790B is connected to the secondary control element 786 to allow the secondary control element 786 to move between an open and closed state, as described above. For example, when the secondary control element 786 is configured as a balloon, the second port 790B can also be connected to a pump device, such as a syringe. The third port 790C can be connected to the spacer 752 and can be connected to the pump device to extend and shorten the spacer 752 along the tubular element 782 as needed.

[0112] The fourth port 790D communicates with the flushing channel 788 and can be connected to a fluid source. Those skilled in the art will understand that although each of ports 790A to 790D is described as being connectable to a separate pump and / or fluid (i.e., gas / liquid) source, ports 790A to 790D can also be connected to one or more pumps and / or fluid (i.e., gas / liquid) sources. Each of ports 790A to 790D may include a valve that can be opened and closed as needed to allow gas or liquid flow through it.

[0113] In another exemplary embodiment, such as Figure 27 As shown, instead of or as a supplement to the secondary control element 786, a clamp 787 prevents leakage of residual discharge remaining in the tubular element 782. This clamp 787 can be clamped onto the tubular element 782 after drainage. In this embodiment, the tubular element 782 is configured such that the outlet end 784 extends beyond the panel 754 to facilitate clamping. In an alternative embodiment, as... Figure 28 As shown, the tube or ostomy bag 714 can be directly connected to the panel 754, rather than having a tube extending from the through-hole 706 of the inflatable member 702. Although not shown, but similar to the stepped groove described with respect to the head of system 400, the panel 754 may include a stepped groove in which a portion of the bag 714 can be received to engage the bag 714 during fecal collection.

[0114] According to another exemplary embodiment, such as Figure 29 As shown, system 800 can be substantially similar to system 700 described above, including an inflatable member 802 configured for insertion into a stoma. However, the inflatable member 802 does not include a through-hole, but is instead configured as a removable balloon. In an operational configuration, the inflatable member 802 is configured to be inserted into the stoma in a deflated state. After insertion through the stoma and into the colon, the inflatable member 802 can then be moved to an inflatable state, in which the inflatable member 802 expands, allowing the contents of the colon to be cleared via the expanded inflatable member 802. In other words, the expanded inflatable member 802 is pulled along the colon and out of the stoma to remove waste from it.

[0115] System 800 also includes a shaft or conduit 804 extending from a first end 808 connected to the inflatable member 802 to a second end 810 extending out of the stoma in the operating position. The conduit 804 should be sufficiently rigid to allow the inflatable member 802 to be inserted through the stoma and guided into the intestine via the conduit 804. In one exemplary embodiment, system 800 also includes a stop 850 immediately adjacent to the second end 810 of the conduit 804. The stop 850 may be formed of a rigid or semi-rigid material extending around a portion of the conduit 804, and is sized and shaped such that when the inflatable member 802 is inserted through the stoma and reaches a threshold distance into the target organ, the stop 850 abuts against the skin of the abdominal wall to prevent further movement of the inflatable member 802 into the target organ. Therefore, the stop 850 prevents the inflatable member 802 from migrating or dislodging during use of system 800.

[0116] To allow the inflatable member 802 to move between a deflated and inflated state, the system 800 includes a connector 811 (e.g., a Luer connector) located at a second end 810 of the piping 804. The connector 811 is configured to connect the piping 804 to, for example, a syringe 826, to inflate the inflatable member 802. In an alternative embodiment, the syringe 826 may be permanently connected to the piping 804 at the second end 810 via a three-way valve. As will be understood by those skilled in the art, the plunger of the syringe 826 can be moved to supply air to the inflatable member 802 as needed to expand / inflate the inflatable member 802 or to pull air out of the inflatable member 802 to deflate the inflatable member 802.

[0117] like Figure 30 As shown, a system 900 according to another exemplary embodiment can be substantially similar to the system described above. However, the system 900 includes a plurality of inflatable members 902A, 902B, 902C, 902D, each having a substantially annular shape, such that the inflatable members 902A, 902B, 902C, 902D can be positioned around different portions of a target organ 90 (e.g., colon) attached to an opening to the abdominal wall 92 to form a stoma 98.

[0118] In one exemplary embodiment, inflatable member 902A may be substantially similar to inflatable member 102, positioned around target organ 90 along the external skin 96 of the abdominal wall such that when the edge of target organ 90 is sutured to skin 96, inflatable member 902A is secured between the skin and the exterior of target organ to form an artificial sphincter of stoma 98. Inflatable member 902A is movable between a deflated and an inflated configuration to open and close the stoma as needed. The remaining inflatable members 902B, 902C, and 902D are positioned internally, adjacent to the inner surface 97 of abdominal wall 92, around target organ 90 and along different portions of its length to form an artificial rectum. Specifically, when the inflatable member 902A moves from the inflatable state to the deflated state to open the stoma 98, each of the inflatable members 902B, 902C, and 902D can move sequentially from the deflated state to the inflatable state, starting with the inflatable member 902B furthest from the stoma 98, to apply radially inward pressure to the target organ 90 to push the excrement toward the stoma 98 and out of the body.

[0119] Once feces have been expelled from stoma 98 as needed, inflatable members 902B, 902C, and 902D can move again toward the deflation position, and stoma 78 can close, thereby inflating inflatable member 902A. Although system 900 is shown and described as including inflatable member 902A to form an artificial sphincter, those skilled in the art will understand that the system can be used without inflatable member 902A to form an artificial sphincter, and that only inflatable members 902B, 902C, and 902D can be used to form an artificial rectum.

[0120] As described above, substantially similar to inflatable member 102, inflatable member 902A is movable between a deflation mode and an inflation mode. Specifically, system 900 may include tubing (not shown) extending from inflatable member 902A, through which inflation fluid (e.g., gas or liquid) may be supplied to and from inflatable member 902A. Similarly, system 900 also includes tubing 990 for supplying inflation fluid (e.g., gas or liquid) to inflatable members 902B, 902C, 902D via, for example, a syringe connected thereto. In one exemplary embodiment, tubing 990 may be connected to and in communication with inflatable member 902B, which, in the operational mode, is furthest from stoma 98.

[0121] Inflatable members 902B, 902C, and 902D can be connected and communicated with each other via a narrow channel 992, such that when the farthest inflatable member 902B is inflated, inflatable fluid supplied via piping 990 flows through the narrow channel 992 to the next farthest inflatable member 902C, and when the next farthest inflatable member 902C is inflated, inflatable fluid flows into the last of the inflatable members 902D, causing inflatable members 902B, 902C, and 902D to inflate sequentially, thereby pushing excrement toward the stoma 98 through the target organ 90. In another embodiment, a valve may be present between the inflatable members, requiring a certain pressure before fluid can pass through it. For example, a valve may be present between inflatable member 902B and the next farthest inflatable member 902C in channel 992, such that inflatable member 902B is fully inflated before the next farthest inflatable member 902C is inflated. Although system 900 shows and describes three of the inflatable members 902B, 902C, 902D that form an artificial rectum, those skilled in the art will understand that an artificial rectum can be formed via any number of inflatable members positioned internally along the target organ 90.

[0122] It will be apparent to those skilled in the art that various modifications can be made to this invention without departing from its scope. Furthermore, those skilled in the art should understand that features of any of the various embodiments can be combined in any manner inconsistent with the description and / or functionality of the embodiments.

Claims

1. An ostomy device comprising: an inflatable member defining a bore extending therethrough, the inflatable member configured to extend around a portion of an intestine proximate to a stoma, the inflatable member movable between a deflated configuration in which the stoma is maintained in an open position and an inflated configuration in which the inflatable member expands to reduce a size of the bore and to close the stoma; and a tube extending from a first end connected to the inflatable member to a second end, a passageway of the tube in communication with an interior of the inflatable member such that inflation fluid is configured to flow through the tube to move the inflatable member between the deflated and inflated configurations.

2. The device of claim 1, wherein the bore of the inflatable member is configured to receive the portion of the intestine proximate to the stoma therein such that in the inflated configuration the inflatable member expands to exert a radially inward pressure around the portion of the inflatable member received therein to close the stoma.

3. The device of any of claims 1-2, further comprising: a bag configured to be attached to an abdominal wall around the stoma such that the tube extends to an interior thereof.

4. The device of claim 3, further comprising: a valve including a first port extending to the interior of the bag to couple to the second end of the tube and a second port extending along an exterior of the bag to couple to an inflation device to provide inflation fluid to the inflatable member, the valve movable between an open configuration in which a path between the first and second ports is open to permit flow therebetween and to inflate the inflatable member and a closed configuration in which the path between the first and second ports is closed.

5. The device of claim 3, wherein the second end of the tube includes a luer connector extending to an exterior of the bag and configured to connect to an inflation device.

6. The device of any of claims 1-5, further comprising: a clamp configured to clamp over the bag and the tube to maintain the inflatable member toward the inflated configuration.

7. The device of claim 2, wherein the inflatable member forms a partial ring extending from a first end to a second end.

8. The device of any of claims 1-7, wherein the inflatable member is configured to be inserted through the stoma and received within the portion of the intestine proximate to the stoma such that the bore of the inflatable member is aligned with a path through the intestine, the device further comprising a tube element extending from a connection end connected to the bore of the inflatable member to an outlet end to draw contents of the intestine passing through the bore of the inflatable member out of the stoma via the outlet end.

9. The apparatus of claim 8, further comprising: a secondary control element housed within the tube element and movable between a closed configuration in which the secondary control element extends across a passage of the tube element to block passage of contents of the intestine therethrough and an open configuration in which the secondary control element unblocks the passage of the tube element to allow passage of contents of the intestine therethrough.

10. The apparatus of claim 9, wherein the secondary control element is configured as a balloon.

11. The apparatus of claim 9, further comprising: a faceplate coupled to the outlet end of the tube element; and an expandable spacer configured to extend between the faceplate and an outer surface of the abdominal wall, a length of the spacer configured to be adjustable along a length of the tube element to achieve a desired distance between the faceplate and the outer surface of the abdominal wall in the operative configuration.

12. The apparatus of claim 11, wherein the faceplate comprises a plurality of ports, each of the plurality of ports configured to be connected to one or more of a plurality of fluid sources to control inflation of the inflatable member, movement of the secondary control element between the open and closed configurations, and adjustment of the length of the expandable spacer.

13. A system for draining contents of an intestine via a stoma, comprising: a plurality of inflatable members, each of the plurality of inflatable members configured to be positioned around a portion of an intestine proximate to an inner surface of an abdominal wall in which the stoma is formed, the inflatable members configured to move from a deflated configuration in which the inflatable members expand radially inward to press against the portion of the intestine received therein toward an inflated configuration, the plurality of inflatable members configured to move from the deflated configuration toward the inflated configuration sequentially from an inflatable member farthest from the stoma to an inflatable member closest to the stoma such that contents of the intestine are urged toward the stoma through the intestine.

14. The system of claim 13, further comprising: a tubing extending from a first end connected to the inflatable member farthest from the stoma to a second end, a passage of the tubing in communication with an interior of the inflatable member farthest from the stoma such that inflation fluid is configured to flow through the tubing to the inflatable member farthest from the stoma; and a passage connecting the plurality of inflatable members such that upon inflation of the inflatable member farthest from the stoma, inflation fluid is allowed to flow into a next adjacent inflatable member to inflate the plurality of inflatable members sequentially from the inflatable member farthest from the stoma to the inflatable member closest to the stoma.

15. The system of any one of claims 13-14, further comprising: An artificial sphincter having a generally annular shape to define a bore extending therethrough, the bore being configured to receive a portion of the intestine immediately proximal to the stoma therethrough, the inflatable member being movable between a deflated configuration in which the stoma is maintained in an open position and an inflated configuration in which the inflatable member expands to reduce the size of the bore such that radial inward pressure is applied to the portion of the intestine received therein to close the stoma.

Images