EP-4739260-A1 - INFLATABLE OSTOMY DEVICE

EP4739260A1EP 4739260 A1EP4739260 A1EP 4739260A1EP-4739260-A1

Abstract

An ostomy device (100) includes an inflatable member (102) and a tubing (104). The inflatable member defines a hole (106) extending therethrough. The inflatable member is configured to extend about a portion of an intestine (10) proximate a stoma (18). In an operative configuration, 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 decrease a size of the hole such and close the stoma. The tubing extends from a first end (108) connected to the inflatable member to a second end (110). A channel (112) of the tubing is in communication with an interior of the inflatable member such that inflation fluid is configured to flow through the tubing to move the inflatable member between the deflated and inflated configurations.

Inventors

SCOTT, Serena
PARKHIDEH, Siavash Sam
ANDREOTTI, Tracy
LEWITZKY, Jennifer
CARNE, Paul
KEENAN, DANIEL
LUIS, Brian

Assignees

Boston Scientific Scimed, Inc.

Dates

Publication Date: 20260513
Application Date: 20241030

Claims (15)

1. An ostomy device, comprising: an inflatable member defining a hole extending therethrough, the inflatable member configured to extend about a portion of an intestine proximate a stoma, in an operative configuration, 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 decrease a size of the hole such and close the stoma; and a tubing extending from a first end connected to the inflatable member to a second end, a channel of the tubing in communication with an interior of the inflatable member such that inflation fluid is configured to flow through the tubing to move the inflatable member between the deflated and inflated configurations.
2. The device of claim 1, wherein the hole of the inflatable member is configured to receive the portion of the intestine proximate the stoma therein so that, in the inflated configuration, the inflatable member expands to apply a radially inward pressure about the portion of the inflatable member received therein to close the stoma.
3. The device of any one of claims 1-2, further comprising: a bag configured to be attached to an abdominal wall about the stoma such that the tubing extends into an interior thereof.
4. The device of claim 3, further comprising: a valve including a first port extending into the interior of the bag to be coupled to the second end of the tubing and a second port extending along an exterior of the bag to be coupled to an inflation device for providing inflation fluid to the inflatable member, the valve movable between an open configuration, in which a pathway between the first and second ports is open to allow a flow therebetween and inflate the inflatable member, and a closed configuration, in which the pathway between the first and second ports is closed.
5. The device of claim 3, wherein the second end of the tubing includes a luer connector which extends to an exterior of the bag and is configured to be connected to an inflation device.
6. The device of any one of claims 1-5, further comprising: a clamp configured to be clamped over the bag and the tubing 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 one of claims 1-7, wherein the inflatable member is configured be inserted through the stoma and received within the portion of the intestine proximate the stoma so that the hole of the inflatable member is aligned with a pathway through the intestine, the device further comprising a tube element extending from a connecting end connected to the hole of the inflatable member to an outlet end to direct intestinal contents passing through the hole of the inflatable member out of the stoma via the outlet end.
9. The device 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 channel of the tube element to block flow of intestinal contents therethrough, and an open configuration, in which the secondary control element unlocks the channel of the tube element to permit a passage of intestinal contents therethrough.
10. The device of claim 9, wherein the secondary control element is configured as a balloon.
11. The device 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 exterior surface of an abdominal wall, in the operative configuration, a length of the spacer configured to be adjustable along a length of the tube element to attain a desired distance between the faceplate and the exterior surface of the abdominal wall.
12. The device of claim 11, wherein the faceplate includes a plurality of ports, each of which is configured to be connected to one or more of a plurality of fluid sources for controlling an inflation of the inflatable member, a 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 intestinal contents via a stoma, comprising: a plurality of inflatable members, each of which is configured to be positioned about a portion of an intestine, proximate an interior surface of an abdominal wall within which the stoma is formed, the inflatable members configured to be moved from a deflated configuration toward an inflated configuration, in which the inflatable members are expanded radially inward to squeeze a portion of the intestine received therein, the plurality of inflatable members configured to be moved 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, so that intestinal contents are pushed through the intestine toward the stoma.
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 channel 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 channel connecting the plurality of inflatable members so that upon inflation of the inflatable member farthest from the stoma, inflation fluid is permitted to flow into a next adjacent inflatable member to sequentially inflate the plurality of inflatable members 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 substantially toroid shape to define a hole extending therethrough, the hole configured to receive a portion of the intestine proximate the stoma therethrough, in an operative configuration, the inflatable member movable between the deflated configuration, in which the stoma is maintained in an open position, and the inflated configuration, in which the inflatable member expands to decrease a size of the hole such that a radial inward pressure is applied to a portion of the intestine received therein to close the stoma.

Description

Inflatable Ostomy Device Inventors: Serena SCOTT, Siavash Sam PARKHIDEH, Tracy ANDREOTTI, Jennifer LEWITZKY, Paul CARNE, Daniel KEENAN, and Brian LUIS Priority Claim [0001] The present disclosure claims priority to U.S. Provisional Patent Application Serial No. 63/597,202 filed November 8, 2023; the disclosure of which is incorporated herewith by reference. Field [0002] The present disclosure relates to ostomy devices and, in particular, relates to ostomy devices including an inflatable member configured as an artificial sphincter for ostomy management. Background [0003] Ostomy procedures (e.g., colostomy, ileostomy) are performed for various patients with diseased or damaged bowels including, for example, colorectal cancer and diverticular disease. Current ostomy procedures include re-routing a part of the colon (or small intestine) to drain outside of the body by bringing an end of the colon to the abdominal wall, where edges of the colon are stitched to the skin to form an opening called a stoma. Stool is then able to drain from the stoma into a bag or pouch attached to the abdomen. Ostomy procedures, however, often result in post-operative complications and/or patient discomfort including, for example, leakage, odor, skin irritation from attachment of the ostomy bag, and social anxiety. Summary [0004] The present disclosure relates to an ostomy device which includes an inflatable member defining a hole extending therethrough, the inflatable member configured to extend about a portion of an intestine proximate a stoma, in an operative configuration, 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 decrease a size of the hole such and close the stoma. The ostomy device also includes a tubing extending from a first end connected to the inflatable member to a second end, a channel of the tubing in communication with an interior of the inflatable member such that inflation fluid is configured to flow through the tubing to move the inflatable member between the deflated and inflated configurations. [0005] In an embodiment, the hole of the inflatable member is configured to receive the portion of the intestine proximate the stoma therein so that, in the inflated configuration, the inflatable member expands to apply a radially inward pressure about the portion of the inflatable member received therein to close the stoma. [0006] In an embodiment, the device further includes a bag configured to be attached to an abdominal wall about the stoma such that the tubing extends into an interior thereof. [0007] In an embodiment, the device further includes a valve including a first port extending into the interior of the bag to be coupled to the second end of the tubing and a second port extending along an exterior of the bag to be coupled to an inflation device for providing inflation fluid to the inflatable member, the valve movable between an open configuration, in which a pathway between the first and second ports is open to allow a flow therebetween and inflate the inflatable member, and a closed configuration, in which the pathway between the first and second ports is closed. [0008] In an embodiment, the second end of the tubing includes a luer connector which extends to an exterior of the bag and is configured to be connected to an inflation device. [0009] In an embodiment, the device further includes a clamp configured to be clamped over the bag and the tubing to maintain the inflatable member toward the inflated configuration. [0010] In an embodiment, the inflatable member forms a partial ring, extending from a first end to a second end. [0011] In an embodiment, the inflatable member is configured be inserted through the stoma and received within the portion of the intestine proximate the stoma so that the hole of the inflatable member is aligned with a pathway through the intestine, the device further comprising a tube element extending from a connecting end connected to the hole of the inflatable member to an outlet end to direct intestinal contents passing through the hole of the inflatable member out of the stoma via the outlet end. [0012] In an embodiment, the device further includes a secondary control element housed within the tube element and movable between a closed configuration, in which the secondary control element extends across a channel of the tube element to block flow of intestinal contents therethrough, and an open configuration, in which the secondary control element unlocks the channel of the tube element to permit a passage of intestinal contents therethrough. [0013] In an embodiment, the secondary control element is configured as a balloon. [0014] In an embodiment, the device further includes a faceplate coupled to the outlet end of the tube element; and an expandable spacer configured to extend between the faceplate and an exterior surface of an