DEVICE FOR SEALING AND DRAINAGE OF A NATURAL OR ARTIFICIAL INTESTINAL OUTLET

• US 20140163312A1
• Filed: 08/23/2013
• Published: 06/12/2014
• Est. Priority Date: 07/23/2004
• Status: Active Grant

• Current Assignee: Advanced Medical Balloons GmbH
• Original Assignee: Fred Gobel
• Inventors: Gbel, Fred
• Granted Patent: US 9,119,697 B2
• Time in Patent Office: Days
• US Class Current: 600/32
• CPC Class Codes: A61F 2/0013 inflatable
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1065 having a balloon which is inversely attached to the shaft at the distal or proximal end
• CPC Class Codes: A61M 2210/1067 Anus
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/10185 Valves
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202

Abstract

The invention relates to a device for sealing and draining an intestinal outlet, the device comprising an inflatable balloon of a generally toroidal structure, whose two ends extend one inside the other, creating a sealed-off volume inside the balloon, whereby the filling of the volume can be adjusted from outside and a draining lumen radially inside the inner layer of the balloon, the outer layer of the tube comprising a radially expanded intra-rectal device which is placed inside the rectum or the intestine of a patient during use, and comprising a trans-anal device which extends through the anus of the patient or his abdominal wall, and a stiffening sleeve element positioned inside the draining lumen of the device, keeping the lumen open and facilitating the uptake and passage of feces through the intra-rectal segment of the draining lumen.

Claims

1. A device for sealing and draining a natural or artificial intestinal outlet, the device comprising an inflatable balloon with a generally toroidal structure, and formed of a flat, everted tube segment whose two ends extend generally coaxially one inside the other and are each connected with their ends to a sleeve, creating a sealed-off volume inside said balloon, whereby the filling of the volume can be adjusted from outside of the body, and creating a draining lumen radially inside an inner layer of said everted balloon, an outer layer of the everted tube segment comprising a radially expanded intra-rectal device portion which is adapted to extend inside the rectum or the intestine of a patient during use, and comprising a trans-anal device portion narrowed with respect thereto, which is adapted to extend through the anus of the patient or his abdominal wall during use, whereby a stiffening sleeve element is positioned inside the draining lumen of said intra-rectal device portion, keeping the lumen open and facilitating the uptake and passage of feces through the intra-rectal segment of the draining lumen, while the two concentric tube layers of said trans-anal device portion, depending on the filling status of the sealed-off volume, can either be collapsed inside the anal channel to a small diameter, thereby forming a non-dilating structure, but allowing for free spontaneous passage of feces, or can unfold and erect inside the anal channel, thereby forming a trans-anally sealing structure with occluded drainage lumen, wherein the stiffening sleeve element extends only inside the intra-rectal device portion and does not extend into said trans-anal device portion, and wherein said balloon is preshaped from thin-walled material with soft foil characteristics, exhibiting only limited compliance, allowing for tissue friendly non-irritating long-term placement and shape consistency under exertion of force, and wherein the material comprises a polyurethane having a shore hardness within a range of 80A to 60D, or a polymer with a similar hardness range.

2. The device according to claim 1, wherein both ends of the tube segment are adapted to be disposed outside the rectum, and outside the anus, and outside the abdominal wall.

3. The device according to claim 1, wherein said balloon is preshaped to, or beyond, working state dimensions thereof, as determined from intestine diameter.

4. The device according to claim 1, wherein the volume inside said balloon is selected such that a wall of said balloon, when being placed and used inside the intestine and anus, is not stretched or distended by a filling volume equal or larger than the volume of the balloon when being freely unfolded outside of the body to its full size, and therefore has a flaccid consistency.

5. The device according to claim 1, wherein pressure inside the sealed-off volume of said balloon, when being placed and used inside the intestine and anus, is adapted to be equal to pressure radially outside of said balloon, due to the unstretched state of said balloon.

6. The device according to claim 1, wherein pressure inside the sealed-off volume of said balloon, when being placed and used inside the intestine and anus, is adapted to be equal to the intrarectal pressure or equal to the intra-abdominal pressure of the patient.

8. The device according to claim 1, wherein said intra-rectal device portion of said outer layer of said everted balloon is provided with a thickness of 40 μ

m or less.

9. The device according to claim 1, wherein said intra-rectal device portion of said outer layer of said everted balloon is provided with a thickness of 15 μ

m or more.

10. The device according to claim 1, wherein the segment of said trans-anal device portion is provided with a thickness of 120 μ

m or less.

11. The device according to claim 1, wherein the tube segment of said trans-anal device portion is provided with a thickness of 30 μ

m or more.

12. The device according to claim 1, wherein the tube segment forming said trans-anal device portion is provided with a Shore hardness of greater than 80A.

13. The device according to claim 12, wherein the stiffening sleeve element has a Shore hardness equal to, or smaller than, the Shore hardness of the tube segment forming said trans-anal device portion.

15. The device according to claim 1, wherein the stiffening, lumen opening sleeve element is not connected to either end of the tube segment forming said balloon.

16. The device according to claim 1, wherein the stiffening, lumen opening sleeve element is integrated into the draining lumen of said intra-rectal device portion of said balloon, and is integrated into a radial expansion of the draining lumen.

17. The device according to claim 1, wherein the stiffening, lumen opening sleeve element is positioned inside an intra-rectal portion of the balloon volume on an outer side of the inner layer of said intra-rectal device portion of said balloon.

18. The device according to claim 1, wherein the stiffening, lumen-opening sleeve element is of a soft polyurethane foam.

19. The device according to claim 1, wherein coaxially arranged tube segments, in said trans-anal device portion, are inter-connected.

20. The device according to claim 1, wherein the opening diameter of the drainage lumen is regulated independently from outside by adjusting the filling status of the volume of said balloon, in said trans-anal device portion, or of a separate lumen occluding and opening balloon element positioned inside the stiffening sleeve element.

21. The device according to claim 20, wherein the lumen occluding balloon element is seated inside the stiffening, lumen opening sleeve element or inside a further proximal portion of the drainage lumen, and in said trans-anal device portion.

22. The device according to claim 21, wherein the lumen occluding balloon is formed from a thin-walled, preshaped material.

23. The device according to claim 22, wherein the lumen occluding balloon is formed as a fully elastically restorable compartment radially inside said balloon, and inside the drainage lumen.

24. The device according to claim 1, wherein a flushing, or irrigation, channel extends from a proximal portion of the device to a distal opening inside the rectum.

25. The device according to claim 1, wherein provided at the stiffening sleeve element, in the region of a distal rim thereof, is a flushing opening connected to a conduit that extends along the trans-anal device portion inside a drainage channel, and is adapted to introduce a flushing fluid.

26. The device according to claim 1, wherein the outer layer of said balloon comprises an outwardly oriented expansion of annular or disk-shaped geometry.

27. The device according to claim 1, wherein the outer layer of said balloon comprises an outwardly oriented expansion comprising two fingers that diverge diametrically from each other.

28. The device according to claim 1, wherein said trans-anal device portion is coated at a radially outer face with a gel.

29. The device according to claim 1, wherein said trans-anal device portion is enclosed by a discrete continuous tube-like foil layer of a thinner material than the balloon material.

30. The device according to claim 1, wherein a medium filled into the volume, is a liquid.

31. The device according to claim 26, wherein the medium filled into the volume allows for drainage of bowel contents or a change of volume occluding the drainage lumen, or facilitates flushing and free trans-anal passage of feces out of the patient.

7. (canceled)

14. (canceled)