Continent ostomy valve and method of use

• US 10,441,455 B2
• Filed: 03/24/2016
• Issued: 10/15/2019
• 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: 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.
• Primary Examiner(s): Zimbouski, Ariana
• Assistant Examiner(s): Townsend, Guy K
• Application Number:
  US15/079,397
• Publication Number:
  US 20160287428A1
• Time in Patent Office: 1,300 Days
• 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 housing connected to the first end, wherein the housing defines an opening that is continuous with the lumen of the hollow tubular member;

a sealing element contained within the lumen;

an anchoring element at or adjacent to the second end; and

one or more protrusions extending from the outer surface of the hollow tubular member, wherein the one or more protrusions are positioned between the housing and the anchoring element;

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, wherein the anchoring element and the hollow tubular member telescope relative to one another to cause extension and retraction of the ostomy valve.

3. The ostomy valve of claim 1, 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, 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 1, 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. The ostomy valve of claim 8, wherein the one or more fins increase in diameter from a proximal most fin to a distal most fin.