Ostomy barrier seal

• US 8,449,513 B2
• Filed: 12/24/2011
• Issued: 05/28/2013
• Est. Priority Date: 12/27/2010
• Status: Active Grant

• Current Assignee: Seal-X Tech LLC
• Original Assignee: Benson Turtleneck Barrier LLC
• Inventors: Abrams, Gilbert L.
• Primary Examiner(s): Deak, Leslie
• Assistant Examiner(s): Townsend, Guy K
• Application Number:
  US13/337,077
• Publication Number:
  US 20120165767A1
• Time in Patent Office: 521 Days
• Field of Search: 604/342, 604/343
• US Class Current: 604/342
• CPC Class Codes: A61F 5/445 Colostomy, ileostomy or urethrostomy devices A61F5/441, A61F5/442, A61F5/443 take precedence
• CPC Class Codes: A61F 5/449 Body securing means, e.g. belts, garments

Abstract

An ostomy barrier seal comprising an open-ended conical base 1; and a flange portion 2 extending radially from the base; wherein the conical base 1 has a top opening 3 and a bottom opening 5 for receiving a stoma of a user and the top opening diameter 9 is smaller than the bottom opening diameter 11; such that the stoma of the user fits through the bottom opening and the top opening expands to snuggly fit around and seal along the stoma wall; a related ostomy appliance incorporating the barrier seal; and a related method using the barrier seal to reduce the incidence of waste leakage in an ostomy patients.

Claims

1. An ostomy barrier seal comprising:

an open-ended conical base (1), wherein the conical base (1) from said top opening (3) to said bottom opening (5) is a uniform thickness; and

a flange portion (2) extending radially from said base;

wherein said conical base and said flange portion consists essentially of a thermoplastic elastomer that is strong and elastic and has a tensile strength (break 73°

F./23°

C.) range from 220 psi to 550 psi and a tensile elongation (break 73°

F./23°

C.) range from 650% to 1110%;

wherein said conical base (1) has a top opening (3) and a bottom opening (5) for receiving a stoma of a user, wherein the top opening diameter (9) is between 20 to 80% smaller than the bottom opening diameter (11) and the interior angle between said conical base and said flange is between 20to 40 degrees;

such that the stoma of the user fits through said bottom opening and said top opening expands and constricts to snuggly fit around and seals along the stoma wall without the use of adhesives or glues.

2. The barrier seal according to claim 1, wherein said thermoplastic elastomer is a styrene block copolymer.

3. The barrier seal according to claim 1, wherein said thermoplastic elastomer is a styrene-butadiene-styrene block copolymer.

4. The barrier seal according to claim 1, wherein the barrier seal is flexible, self-aligning and has continuous sealing ability to accommodate stoma movement.

5. The barrier seal according to claim 1, wherein said bottom opening diameter (11) has a range between 1/4 ″

to 3″

.

6. The barrier seal according to claim 1, wherein conical base (1) has a height that is dependent on the diameter of said top opening diameter, such that the smaller said top opening diameter the higher said conical base.

7. The barrier seal according to claim 1) wherein conical base (1) has a height that is dependent on the diameter of said top opening diameter, such that the larger said top opening diameter the shorter said conical base.

8. The barrier seal according to claim 1, wherein said flange portion (2) further comprises a locking mechanism (8) on the underside surface.

9. The barrier seal according to claim 8, wherein said locking mechanism (8) attaches to an ostomy barrier.

10. The barrier seal according to claim 1, further comprising at least one bellow (12) between said base (7) and said flange portion (2).

11. The barrier seal according to claim 1, wherein the underside of said flange has an adhesive surface (4).

12. The barrier seal according to claim 11, wherein said adhesive surface (4) attaches to the users skin.

13. The barrier seal according to claim 11, wherein said adhesive surface (4) attaches to an ostomy barrier.

14. The barrier seal according to claim 11, wherein said adhesive surface (4) attaches to an ostomy pouching device.

15. An ostomy barrier seal comprising:

an open-ended base (1) having a top edge (6) which forms a top opening (3) and a bottom edge (7) which forms a bottom opening (5) for receiving a stoma of a user, wherein the bottom opening diameter is smaller than the top opening diameter;

wherein the open-ended base (1) from said top edge (6) to said bottom edge (7) is a uniform thickness;

at least one bellow portion (12) extending radially from said bottom edge, wherein the outside angle between the bottom opening and the bellow is between 20 to 40 degrees; and

a flange portion extending radially from said bellow;

wherein said open-ended base consisting essentially of a thermoplastic elastomer that is strong and elastic and has a tensile strength (break 73°

F./23°

C.) range from 220 psi to 550 psi and a tensile elongation (break 73°

F./23°

C.) range from 650% to 1110%;

such that the stoma of the user fits through said top opening and said bottom opening wherein said bottom opening expands and constricts to snuggly fit around and seal along the stoma wall without the use of adhesives or glues.

16. An ostomy appliance comprised of:

a barrier seal including an open-ended base (1) having a first opening (21) and a second opening (22) at opposite ends of the base for receiving the stoma of a user,

wherein said first opening and said second opening are different diameters;

a flange portion (2) extending radially from said second opening; and

a barrier;

wherein said open-ended base (1) from the first opening (21) to the second opening (22) is a uniform thickness, and consists essentially of a thermoplastic elastomer that is strong and elastic and has a tensile strength (break 73°

F./23°

C.) in the range from 220 psi to 550 psi and a tensile elongation (break 73°

F./23°

C.) in the range from 650% to 1110%;

such that the stoma of the user fits through said first and second openings and expands and constricts to snuggly fit around and seal along the stoma wall.

17. The ostomy appliance according to claim 16, wherein the first opening diameter is smaller than the second opening diameter, such that the stoma of the user fits through said second opening;

and said first opening expands to snuggly fit around and seal along the stoma wall.

18. The ostomy appliance according to claim 16, wherein said second opening diameter is smaller than said first opening diameter, such that the stoma of the user fits through said first opening and said second opening expands and constricts to snuggly fit around and seal along the stoma wall.

19. The ostomy appliance according to claim 16, further comprising an ostomy pouch;

wherein said ostomy pouch is attached to said barrier.

20. A method to reduce the incidence of waste leakage in an ostomy patient comprising the steps of:

providing an ostomy barrier seal comprising an open-ended conical base having a top opening and a bottom opening of different diameters at opposite ends of the base for receiving the stoma of a user, wherein the conical base from the top opening to the bottom opening is a uniform thickness; and

a flange portion extending radially from said base;

wherein said open-ended base consists essentially of a thermoplastic elastomer having a tensile strength (break 73°

F./23°

C.) range from 220 psi to 550 psi and a tensile elongation (break 73°

F./23°

C.) range from 650% to 1110%;

attaching said barrier seal to a barrier;

applying said barrier over the stoma of a patient such that said barrier seal expands and constricts to fit snuggly over the stoma and without glue or adhesive forms a fluid tight seal along the stoma wall; and

attaching an ostomy pouch to said barrier;

wherein said barrier seal reduces and prevents waste leakage.

21. The method according to claim 20, wherein the top opening diameter is smaller than the bottom opening diameter;

such that the stoma of the user fits through said bottom opening and said top opening expands to snuggly fit around and seal along the stoma wall.

22. The method according to claim 20, wherein the bottom opening diameter is smaller than the top opening diameter.

23. The method according to claim 22, wherein said barrier seal further comprises at least one bellows portion between said bottom opening and said flange portion;

such that the stoma of the user fits through said top opening and said bottom opening expands and constricts to snuggly fit around and seal along the stoma wall.

24. The barrier seal according to claim 20, wherein the barrier seal is flexible, self-aligning and has continuous sealing ability to accommodate stoma movement.