Closing system for a natural or artificial anus

• US 20110306823A1
• Filed: 02/14/2011
• Published: 12/15/2011
• Est. Priority Date: 07/23/2003
• Status: Active Grant

• Current Assignee: Göbel, Fred, Göbel, Lothar
• Original Assignee: Göbel, Fred, Göbel, Lothar
• Inventors: Göbel, Fred, Göbel, Lothar
• Granted Patent: US 9,186,233 B2
• Time in Patent Office: Days
• US Class Current: 600/32
• CPC Class Codes: A61F 2/0013 inflatable
• CPC Class Codes: A61F 5/445 Colostomy, ileostomy or urethrostomy devices A61F5/441, A61F5/442, A61F5/443 take precedence

Abstract

The invention relates to a closing system for a natural or an artificial anus, comprising an inflatable balloon having an approximately toroidal structure, composed of a plane tubular section folded in on itself, the ends of which (13, 14) extend coaxially within each other and are linked to a sleeve.

Claims

1. A closing system for a natural or an artificial intestinal outlet, with an inflatable balloon (12) having an approximately toroidal structure, characterized in that the balloon (12) is

a) made from a pre-shaped thin-walled soft-foil of a polymer of low compliance, preferably of a polymer with a compliance like polyvinyl chloride or lower, and

b) formed of a hose segment with a two-dimensional surface, which hose is inverted into itself, whereby its two ends (13,14) extend roughly coaxially with each other and are (each) connected to a respective sleeve.

2. The closing system as recited in claim 1, characterized in that said balloon (12) is preshaped by fabrication to the maximum inside diameter of the organ space or body cavity, in which the inverted balloon structure is placed.

3. The closing system as recited in claim 1, characterized in that said balloon (12) is preshaped by fabrication to a diameter, which is exceeding the maximum inside diameter of the organ space or body cavity, which the inverted balloon structure is placed in, by 10 to 50%, preferably 20 to 40%.

4. The closing system as recited in one of the preceding claims, characterized in that said balloon (12) is made of a thin-walled soft-foil polymer, whereby the wall-thickness of the toroidal balloon portion is ranging from 10 to 50 micrometers, preferably 15 to 25 micrometers.

5. The closing system as recited in one of the preceding claims, characterized in that said polymer is a polyurethane, a polyurethane/polyvinyl chloride blend or a comparable polyurethane-based material.

6. The closing system as recited in one of the preceding claims, characterized in that said polymer is a polyurethane in a Shore hardness range of 70A to 60D, preferably 90A to 55D.

7. The closing system as recited in one of the preceding claims, characterized in that said balloon (12) is sealing the intestine against fecal material and intestinal secretions at a filling pressure of the balloon of 10 to 30 mbar, preferably 15 to 25 mbar.

8. The closing system as recited in one of the preceding claims, characterized in that said connection port (14) is having a thicker wall than the other segments of the balloon structure (12).

9. The closing system as recited in claim 8, characterized in that said connection port (14) is having a wall thickness of 25 to 100 μ

m, preferably 30 to 50 μ

m.

10. The closing system as recited in one of the preceding claims, characterized in that said connection port (14) in the inverted assembled and pressurized balloon collapses to flat structure, shaping channel like bowel gas releasing eyelets (36) within its lateral portions.

11. The closing system as recited in claim 10, characterized in that said bowel gas releasing eyelets (36), at a balloon filling pressure of 20 mbar have a smallest inner diameter of 0.3 to 2.0 mm, preferably 0.5 to 1.5 mM.

12. The closing system as recited in one of the preceding claims, characterized in that said connection port (14) is reinforced by a fixed supporting tube-foil element (102) or an additional material layer (102).

13. The closing system as recited in one of the preceding claims, characterized in that said connection port (14) is reinforced by an inserted and from the outside removable supporting tube-foil element (102).

14. The closing system as recited in claim 12 or 13, characterized in that said connection port (14) in the collapsed state shapes said bowel gas releasing eyelets (36), at a balloon filling pressure of 20 mbar having a smallest inner diameter of 0.5 to 2.3 mm, preferably 0.75 to 1.5 mm.

15. The closing system as recited in one of the preceding claims, characterized in that said connection ports (13, 14) or ends of said balloon (12) are preformed such that each or both of the end regions (13, 14) of the inverted hose segment have a roughly constant cross section, i.e., one having a constant cross-sectional length.

16. The closing system as recited in one of the preceding claims, characterized in that the inverted hose is preformed such that its front end, which is distal relative to the mutually coaxially ends, assumes in the inflated state a gently curved contour with no edge regions.

17. The closing system as recited in one of the preceding claims, characterized in that said balloon is preformed such that it has in the inflated state a diameter D that exceeds the diameter d of the bowel segment.

18. The closing system as recited in one of the preceding claims, characterized in that the collapsed balloon (12) is housed in a cavity (11), which is provided in a plug (2) and is directed toward the interior of the bowel.

19. The closing system as recited in one of the preceding claims, characterized in that the collapsed balloon (12) is housed in a sheathing piece of thin-walled and pliable foil tubing (100) and is directed toward the interior of the bowel.

20. The closing system as recited in one of the preceding claims, characterized in that two connection ports (13, 14) of said balloon (12) are each connected by their mouths to said plug (2).

21. The closing system as recited in one of the preceding claims, characterized in that said plug (2) is composed of two sleeves (3, 4) that is can be fitted one inside the other and in that the mouth (15, 16) of each connection port (13, 14) is connected to a respective one of said sleeves (3, 4).

22. The closing system as recited in one of the preceding claims, characterized in that the mouth (15) than can be connected to the outer sleeve (3) has a diameter adapted to said outer sleeve (3), and the moth (16) that can be connected to the inner sleeve (4) has a diameter adapted to said inner sleeve (4).

23. The closing system as recited in one of the preceding claims, characterized in that said balloon (12) can be pulled through a sleeve, preferably said outer sleeve (3).

24. The closing system as recited in one of the preceding claims, characterized in that a filter (21) is or can be disposed inside a sleeve, preferably said inner sleeve (4).

25. The closing system as recited in one of the preceding claims, characterized in that said plug (2) and/or one or more sleeves is/are connectable to a sealing cap (10).

26. The closing system as recited in claim 25, characterized in that said sealing cap (10) is connected in adjacent contact to said plug (2).

27. The closing system as recited in claim 25 or 26, characterized in that

said sealing cap has a folded structure.

28. The closing system as recited in one of claims 28 to 27, characterized in that said sealing cap (10) and/or said plug (2) is connectable to a collection bag (23).

29. The closing system as recited in one of the preceding claims, characterized in that said the connecting outer port (13) is having in free inflation outside the body an outer diameter of 5 to 15 mm, preferably 7 to 12 mm

30. The closing system as recited in one of the preceding claims, characterized in that said the connecting outer port (13) is having in free inflation outside the body that is about equal to the diameter of the distal toroidal portion.

31. The closing system as recited in the prior claim, characterized in that said the connecting outer port (13) is having in free inflation outside the body within its trans-anal segment, a preformed shape with a taper or waist of 2-5 cm in diameter.

32. The closing system as recited in one of the preceding claims 28 to 31, characterized in that the collection receptacle (23) is connectable to said sealing cap (10) and to said inner sleeve (4).

33. The closing system as recited in one of the preceding claims, characterized in that the ends of the hose segment, which is inverted to form the balloon (12), are not in direct contact with each other.