Bowel management system and waste collection bag therefor

• US 7,722,583 B2
• Filed: 04/28/2006
• Issued: 05/25/2010
• Est. Priority Date: 08/21/2002
• Status: Expired due to Fees

• Current Assignee: Hollister Incorporated
• Original Assignee: Hollister Incorporated
• Inventors: Minasi, John S., von Dyck, Peter M., Kim, Jae H., Schneider, James G., Martino, Nick
• Primary Examiner(s): Zalukaeva; Tatyana
• Assistant Examiner(s): Treyger; Ilya Y
• Application Number:
  US11/413,388
• Publication Number:
  US 20060189951A1
• Time in Patent Office: 1,488 Days
• Field of Search: 604/239, 604/317, 604/329
• US Class Current: 604/317
• CPC Class Codes: A61M 2202/068 Faeces; Excretions
• CPC Class Codes: A61M 2210/1067 Anus
• CPC Class Codes: A61M 3/0241 the liquid being supplied by gravity
• CPC Class Codes: A61M 3/0262 manually, e.g. by squeezing a bulb
• CPC Class Codes: A61M 3/027 Devices for holding the cannula in position, e.g. belts cannula details A61M3/0279
• CPC Class Codes: A61M 3/0295 with inflatable balloon

Abstract

A bowel management system includes a waste collection catheter having at least two distinct sections. The first section is patient proximal when disposed in the patient'"'"'s rectum and has durometer hardness in the range of about 50 A to about 90 A. The second catheter section is connected to the first section and has durometer hardness in the range of about 5 A to about 49 A. A selectively collapsible, substantially spherical retention balloon is attached coaxially and exterior of the first catheter section such that the proximal-most end of the retention balloon is coincident to the proximal-most end of the first section of the waste collection catheter, the substantially spherical retention balloon having an inflated size so as to be sufficiently large enough to retain the patient proximal end of the catheter in the patient'"'"'s rectum without being so large as to trigger a defecatory response in the patient.

Claims

1. A bowel management system comprising:

a rectally inserted catheter having a first catheter section having a patient proximal opening that, when in position for normal use, is in a patient'"'"'s rectum to receive bowel waste, and a second catheter section located distal to the first section that, when in position for normal use, can be collapsed by a patient'"'"'s anal sphincter muscles;

the first catheter section being sufficiently pliable to permit folding for insertion into a patient'"'"'s rectum but following insertion permits flow of bowel waste through the patient proximal opening;

the second catheter section permitting passage of bowel waste from the patient and being sufficiently soft to permit retention within a patient'"'"'s anal canal for extended periods of time; and

a balloon coaxial with, and extending radially outward relative to, the patient proximal opening of the first catheter section for retaining the patient proximal opening in a position for normal use where it opens into the rectum of the patient, and the balloon having a proximal-most end coincident to a proximal-most first end of the first catheter section, the balloon having an inflated size sufficiently large so as to prevent migration of the first catheter section out of the patient'"'"'s rectum through the patient'"'"'s anal canal without being so large as to trigger a defecatory response in the patient.

2. The bowel management system of claim 1 further including a lumened member substantially smaller in diameter than the first catheter section and having a first end in communication with the balloon and a second end connectable to a port for introduction or removal of a fluid to or from the balloon.

3. The bowel management system of claim 2 including a second lumened member substantially smaller in diameter than the first catheter section and having a first end in communication with a patient'"'"'s rectum and a second end connected to an irrigation port for administering substances.

4. The bowel management system of claim 3 wherein the administered substances include at least one of a medication or an enema solution.

5. The bowel management system of claim 1 further comprising a third catheter section positioned distal to the second catheter section and coated internally with a substance to facilitate passage of bowel waste.

6. The bowel management system of claim 1 wherein at least one of the first catheter section and the second catheter section includes silicone.

7. The bowel management system of claim 1 further comprising a third catheter section positioned distal to the second catheter section and coated externally with a substance to facilitate milking.

8. The bowel management system of claim 1 further comprising a strap provided on a faceplate, the faceplate being mounted to an exterior of a third catheter section positioned distal to the second catheter section.

9. The bowel management system of claim 1 and further comprising an intralumenal balloon mounted to an interior of the first catheter section.

10. The bowel management system of claim 1, wherein the first catheter section has a durometer hardness in the range of about 50A to about 90A.

11. The bowel management system of claim 1, wherein the second catheter section has a durometer hardness in the range of about 5A to about 49A.

12. The bowel management system of claim 1, wherein the first catheter section has a durometer hardness in the range of about 50A to about 90A and the second catheter section has a durometer hardness in the range of about 5A to about 49A.

13. A bowel management system for use in a patient comprising:

a waste collection catheter having a first catheter section which is patient proximal and which is disposed in the patient'"'"'s rectum in a normal use position;

the waste collection catheter also having a second catheter section which is positioned patient distal in normal use, the second catheter section being coated at least one of internally with a substance to facilitate flow-through of waste matter from the patient or externally with a substance to facilitate milking of the waste collection catheter by a caretaker for the patient; and

a selectively collapsible retention balloon attached coaxially and exterior of the patient proximal first section, the balloon having a proximal-most end coincident to a proximal-most first end of the first catheter section.

14. The system of claim 13, further comprising a lumened member including a first lumen which has a first end and a second end, the first end of the lumened member being in fluid communication with the selectively collapsible retention balloon, and wherein the second end of the lumened member is connectable to a port for introduction or removal of fluid from the retention balloon, for selective inflation and deflation of the retention balloon as necessary for insertion, retention or removal of the patient proximal first catheter section to, in or from the patient'"'"'s rectum.

15. The system of claim 13, further comprising an intralumenal balloon mounted to the patient proximal first catheter section of the waste collection catheter.

16. The system of claim 15, wherein the intralumenal balloon is in fluid communication with a second lumen to thereby permit selective inflation and deflation of the intralumenal balloon.

17. The system of claim 16, further comprising a lumened member including a first lumen which has a first end and a second end, the first end of the lumened member being in fluid communication with the selectively collapsible retention balloon, and wherein the second end of the lumened member is connectable to a port for introduction or removal of fluid from the retention balloon, for selective inflation and deflation of the retention balloon as necessary for insertion, retention or removal of the patient proximal first catheter section to, in or from the patient'"'"'s rectum;

and wherein the second lumen is included in the lumened member.

18. The system of claim 15, further comprising a lumened member including a first lumen which has a first end and a second end, the first end of the first lumen being in fluid communication with the intralumenal balloon, and wherein the second end of the first lumen is connectable to a port for introduction or removal of fluid from the intralumenal balloon, for selective inflation and deflation of the intralumenal balloon.

19. The system of claim 18, further comprising a second lumen permitting introduction of substances to the patient'"'"'s rectum.

20. The system of claim 19, wherein the second lumen is included in the lumened member.

21. The system of claim 13, further comprising a lumen in fluid communication with the patient proximal first section and permitting introduction of substances to the patient'"'"'s rectum.

22. The system of claim 13, further comprising an intralumenal balloon mounted to the patient proximal first catheter section of the waste collection catheter, a first lumen, a second lumen and a third lumen, the first lumen being in fluid communication with the selectively collapsible retention balloon to thereby permit selective inflation and deflation of the retention balloon as necessary for insertion, retention or removal of the patient proximal first catheter section to, in or from the patient'"'"'s rectum, the second lumen permitting introduction of substances to the patient'"'"'s rectum, and the third lumen being in fluid communication with the intralumenal balloon.

23. The system of claim 22, wherein at least two of the first, second, and third lumens are included in a multi-lumen member.

24. The system of claim 13, wherein at least one of the first catheter section and the second catheter section of the waste collection catheter includes silicone.

25. The system of claim 13, wherein the first catheter section has a durometer hardness in the range of about 50A to about 90A.

26. The system of claim 13, further including a third catheter section disposed between the first catheter section and the second catheter section, wherein the third catheter section has a durometer hardness in the range of about 5A to about 49A.

27. The system of claim 13, further including a third catheter section disposed between the first catheter section and the second catheter section, wherein the first catheter section has a durometer hardness in the range of about 50A to about 90A and the third catheter section has a durometer hardness in the range of about 5A to about 49A.