CONTINENT OSTOMY VALVE AND METHOD OF USE

• US 20160287428A1
• Filed: 03/24/2016
• Published: 10/06/2016
• Est. Priority Date: 04/02/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation), Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation), Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Inventors: Eggert, Joel T., Pennington, Douglas, Rohl, James P., Pagoria, Douglas D., Faubion, William A., Dozois, Eric J., Fettig, Jonathan P.
• Granted Patent: US 10,441,455 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 5/4405 Valves or valve arrangements specially adapted therefor A61F5/441 takes precedence; Fluid inlets or outlets A61F5/4407 takes precedence
• CPC Class Codes: A61F 5/445 Colostomy, ileostomy or urethrostomy devices A61F5/441, A61F5/442, A61F5/443 take precedence

Abstract

Methods and materials related to ostomy devices, and particularly to valves for use with continent ostomies (e.g., ileostomies) are provided herein.

Claims

1. An ostomy valve comprising:

a hollow tubular member having a first end, a second end, an outer surface, an inner surface, and a lumen extending axially through the tubular member between the first and second ends;

a sealing element contained within the lumen; and

an anchoring element at or adjacent to the second end;

wherein the ostomy valve is reversibly adjustable between a radially expanded configuration for retention in a stoma, and a non-radially expanded configuration for insertion into or removal from the stoma.

2. The ostomy valve of claim 1, further comprising a housing connected to the first end, wherein the housing defines an opening that is continuous with the lumen of the hollow tubular member.

3. The ostomy valve of claim 2, wherein the sealing element is contained within the opening of the housing.

4. The ostomy valve of claim 1, wherein the hollow tubular member comprises high elongation tubing.

5. The ostomy valve of claim 1, wherein the sealing element comprises silicone or isoprene.

6. The ostomy valve of claim 1, wherein the sealing element is configured to allow passage of a tube or catheter through the sealing element, and to effectively seal the valve after the tube or catheter is removed from the sealing element.

7. The ostomy valve of claim 1, wherein the anchoring element is defined by a widening of the hollow tubular member, such that a cross-sectional diameter of the hollow tubular member through the anchoring element is greater than a cross-sectional diameter of the hollow tubular member through the first end.

8. The ostomy valve of claim 7, wherein the widening comprises one or more fins defined by the outer surface of the hollow tubular member.

9. The ostomy valve of claim 7, wherein the widening comprises a portion of the outer surface of the hollow tubular member that is at an obtuse angle with respect to the outer surface at the first end of the hollow tubular member.

10. The ostomy valve of claim 1, further comprising one or more protrusions extending from the outer surface of the hollow tubular member, wherein the one or more protrusions are configured to reduce the likelihood that mucous, waste, or other bodily fluids will leak from a stoma when the ostomy valve is seated in the stoma.

11. The ostomy valve of claim 10, wherein the one or more protrusions extend circumferentially around the outer surface of the hollow tubular member.

12. The ostomy valve of claim 1, wherein the valve has a length from the first end to the second end of about 1 cm to about 10 cm, and an external diameter of about 0.5 cm to about 2 cm, exclusive of the anchoring element.

13. A device for use with an ostomy valve comprising:

a hollow outer tube having a first end and a second end, wherein the first end is attached to a first handle;

an inner shaft positioned axially and slidably within the hollow outer tube, wherein the inner shaft has a first end and a second end, wherein the first end is attached to a second handle, and wherein a portion of the inner shaft proximate to its first end passes through an opening in the first handle;

an inflatable balloon positioned on an outer surface of the hollow outer tube distal to the first handle; and

an inflation port in fluid communication with the inflatable balloon, wherein the inflation port extends from the inflatable balloon toward the first handle.

14. The device of claim 13, wherein force exerted on the first and second handles to bring them closer together causes the second end of the inner shaft to extend beyond the second end of the hollow outer tube.

15. The device of claim 13, wherein the second end of the inner shaft defines a protrusion configured to engage a complementary feature on the inner surface of an ostomy valve that comprises:

a hollow tubular member having a first end, a second end, an outer surface, an inner surface, and a lumen extending axially through the tubular member between the first and second ends;

a sealing element contained within the lumen; and

an anchoring element at or adjacent to the second end,

wherein the ostomy valve is reversibly adjustable between a radially expanded configuration for retention in a stoma, and a non-radially expanded configuration for insertion into or removal from the stoma.

16. The device of claim 15, wherein when the protrusion is engaged with the complementary feature, force exerted on the first and second handles to bring them closer together causes the second end of the inner shaft to extend beyond the second end of the hollow outer tube, such that the ostomy valve is elongated into a non-radially expanded configuration.

17. A system comprising one or more ostomy valves and a packaging material, wherein each valve comprises:

a hollow tubular member having a first end, a second end, an outer surface, an inner surface, and a lumen extending axially through the tubular member between the first and second ends;

a sealing element contained within the lumen; and

an anchoring element at or adjacent to the second end,

wherein each ostomy valve is reversibly adjustable between a radially expanded configuration for retention in a stoma, and a non-radially expanded configuration for insertion into or removal from the stoma.

18. The system of claim 17, wherein each ostomy valve has a length from the first end to the second end of about 1 cm to about 10 cm, and an external diameter of about 0.5 cm to about 2 cm, exclusive of the anchoring element.

19. The system of claim 17, further comprising a device that includes:

a hollow outer tube having a first end and a second end, wherein the first end is attached to a first handle;

an inner shaft positioned axially and slidably within the hollow outer tube, wherein the inner shaft has a first end and a second end, wherein the first end is attached to a second handle, and wherein a portion of the inner shaft proximate to its first end passes through an opening in the first handle;

an inflatable balloon positioned on an outer surface of the hollow outer tube distal to the first handle; and

an inflation port in fluid communication with the inflatable balloon, wherein the inflation port extends from the inflatable balloon toward the first handle.

20. The system of claim 19, wherein the second end of the inner shaft of the device defines a protrusion configured to engage a complementary feature on the inner surface of the one or more ostomy valves.