Bowel management system

• US 7,147,627 B2
• Filed: 08/21/2002
• Issued: 12/12/2006
• 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): WILLIAMS, CATHERINE SERKE
• Application Number:
  US10/225,820
• Publication Number:
  US 20040039348A1
• Time in Patent Office: 1,574 Days
• Field of Search: 604/19, 604/27, 604/28, 604/30, 604/34, 604/500, 604514-517, 604/93.01, 604/96.01, 604/99.04, 604/104, 604/275, 604/276, 604/277, 604/278, 604/523, 604/525, 604/317, 604/323, 604/327, 604/328, 604/335
• US Class Current: 604/327
• 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 50A to about 90A. The second catheter section is connected to the first section and has durometer hardness in the range of about 5A to about 49A. 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 for use in a patient comprising:

a waste collection catheter having at least two distinct sections of varying durometer hardness including;

a first section which is patient proximal and which is disposed in the patient'"'"'s rectum in normal use position, having a first end and a second end, and a durometer hardness in the range of about 50A to about 90A, so that the catheter patient proximal section is stiff enough to automatically maintain an open position for free flow of bowel waste when in normal use position with a retention balloon inflated, yet is soft and pliable enough to permit folding longitudinally for ease of insertion into the rectum of the patient;

a second section having a first end connected to the second end of the patient proximal section, and a second end, and a durometer hardness in the range of about 5A to about 49A, so that the second section can be positioned and retained in the anal canal of the patient for extended periods without distending the sphincters or causing discomfort; and

a selectively collapsible, substantially spherical retention balloon attached coaxially and exterior of the patient proximal first catheter section such that the proximal-most end of the retention balloon is coincident to the proximal-most first end of the patient proximal 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.

2. The system of claim 1, and further comprising a lumened member which is substantially smaller in diameter than the waste collection catheter and which has a first end and a second end, the first end of the lumened member being connected to the patient proximal first section of the waste collection catheter and 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 rectal catheter patient proximal segment to or from the patient'"'"'s rectum.

3. The system of claim 2, wherein the lumened member has at least two independent lumens, each of the lumens being connectable at the second end of the lumened member to a port for introduction or removal of fluid from the system, one of the two lumens being in fluid communication with the first end of the patient proximal segment of the waste collection catheter, to thereby permit introduction of treatment substances to the patient'"'"'s rectum.

4. The system of claim 1, wherein the retention balloon has an inflated length-to-diameter ratio in the range of about 0.75 to about 0.61, with a volume of about 44 cc to about 69 cc.

5. The system of claim 4, wherein the retention balloon has a length of 1.35 inches and a diameter of 1.8 inches.

6. The system of claim 4, wherein the retention balloon has a length of 1.35 inches and a diameter of 2.32 inches.

7. The system of claim 1, and further comprising an intralumenal balloon mounted to an interior of the patient proximal first segment of the waste collection catheter.

8. The system of claim 7, wherein the intralumenal balloon is in fluid communication with a lumen of the lumened member to thereby permit selective inflation and deflation of the intralumenal balloon and to function as an anti-reflux device.

9. The system of claim 3, and further comprising an intralumenal balloon mounted to the patient proximal end of the waste collection catheter, wherein the lumened member has 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 collapse the retention balloon as necessary for insertion, retention or removal of the rectal catheter patient proximal first segment to or from the patient'"'"'s rectum, the second lumen being in fluid communication with the inside of the patient proximal first segment of the waste collection catheter, to thereby permit introduction of substances to the patient'"'"'s rectum, and the third lumen being in fluid communication with the intralumenal balloon.

10. The system of claim 1, and further comprising a third section of the waste collection catheter, which is positioned patient distal in normal use.

11. The system of claim 10, wherein the third section of the waste collection catheter is coated internally with a substance to facilitate flow-through of waste matter from the patient.

12. The system of claim 10, wherein the patient distal third section of the waste collection catheter is coated externally with a substance to facilitate “

milking”

of the waste collection catheter by a caretaker for the patient.

13. The system of claim 10, wherein the patient distal third section of the collection catheter is coated internally with a substance to facilitate flow-through of waste matter from the patient and coated externally with a substance to facilitate “

milking”

of the waste collection catheter by a caretaker for the patient.

15. The system of claim 10, wherein the patient distal third segment is formed of a non-latex material to ensure against allergic reactions by the patient and the caregiver.

16. The system of claim 10, and further comprising a selectively openable and closeable access port in the patient distal third segment of the waste collection catheter to thereby permit access to the internal catheter for sampling and insertion of medication and fluids.

17. The system of claim 1, and further comprising a connector for permitting facile, releasable attachment of the system to the patient.

18. The system of claim 1, and further comprising at least one flexible strip connected adjacent to the second end of the second section of the waste collection catheter, to thereby provide optional means by which to releasably attach the waste collection catheter to the non-ambulatory patient to stabilize and secure the system in use position.

19. The system of claim 1, and further comprising a face plate of soft, pliable material, the faceplate being disposed adjacent to the second end of the second section of the waste collection catheter to thereby provide stability to the system in use position.

20. The system of claim 10, and further comprising a closure member connectable to the second end of the patient distal third segment of the waste collection catheter.

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

a waste collection catheter having at least two distinct sections of varying durometer hardness including;

a first section which is patient proximal and which is disposed in the patient'"'"'s rectum in normal use position, having a first end and a second end, and a durometer hardness in the range of about 50A to about 90A, so that the catheter patient proximal section is stiff enough to automatically maintain an open position for free flow of bowel waste when in normal use position with a retention balloon inflated, yet is soft and pliable enough to permit folding longitudinally for ease of insertion into the rectum of the patient;

a second section having a first end connected to the second end of the patient proximal section, and a second end, and a durometer hardness in the range of about 5A to about 49A, so that the second section can be positioned and retained in the anal canal of the patient for extended periods without distending the sphincters or causing discomfort; and

a third section of the waste collection catheter, which is positioned patient distal in normal use, wherein the third section of the catheter has a flush port to thereby permit the infusion of sufficiently large volumes of fluid into the system to permit irrigation of the patient'"'"'s bowel.

21. A method for inserting a bowel management system into a patient, the method comprising:

(a) providing a bowel management system, the system having;

a waste collection catheter having at least two distinct sections of varying durometer hardness including;

a first section which is patient proximal and which is disposed in the patient'"'"'s rectum in normal use position, having a first end and a second end, and a durometer hardness in the range of about 50A to about 90A, so that the catheter patient proximal section is stiff enough to automatically maintain an open position for free flow of bowel waste when in normal use position with retention balloon inflated, yet is soft and pliable enough to permit folding longitudinally for ease of insertion into the rectum of a patient;

a second section having a first end connected to the second end of the patient proximal section, and a second end, and a durometer hardness in the range of about 5A to about 49A, so that the second section can be positioned and retained in the anal canal of the patient for extended periods without distending the sphincters or causing discomfort; and

a selectively collapsible, substantially spherical retention balloon attached coaxially and exterior of the patient proximal first catheter section such that the proximal-most end of the retention balloon is coincident to the proximal-most first end of the patient proximal 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;

(b) folding the patient proximal first end of the waste collection catheter longitudinally;

(c) inserting the folded patient proximal first end of the waste collection catheter into the patient'"'"'s rectum sufficiently far that the selectively collapsible, substantially spherical retention balloon is entirely within the patient'"'"'s rectum; and

d) securing the waste collection catheter in the position to which it has been inserted so that the catheter does not become separated from the patient during an extended period of time, in the range of hours, while the patient'"'"'s body waste is permitted to drain out of the patient'"'"'s body through the waste collection catheter.

23. The method of claim 21, wherein securing the waste collection catheter in the position to which it has been inserted includes the step of inflating the substantially spherical retention balloon so that the ratio of balloon length-to-diameter is in the range of about 0.75 to about 0.61.

22. A method for inserting a bowel management system into a patient, the method comprising:

(a) providing a bowel management system, the system having;

a waste collection catheter having at least two distinct sections of varying durometer hardness including;

a first section which is patient proximal and which is disposed in the patient'"'"'s rectum in normal use position, having a first end and a second end, and a durometer hardness in the range of about 50A to about 90A, so that the catheter patient proximal section is stiff enough to automatically maintain an open position for free flow of bowel waste when in normal use position with retention balloon inflated, yet is soft and pliable enough to permit folding longitudinally for ease of insertion into the rectum of a patient;

a second section having a first end connected to the second end of the patient proximal section, and a second end, and a durometer hardness in the range of about 5A to about 49A, so that the second section can be positioned and retained in the anal canal of the patient for extended periods without distending the sphincters or causing discomfort; and

a selectively collapsible, substantially spherical retention balloon attached coaxially and exterior of the patient proximal first catheter section such that the proximal-most end of the retention balloon is coincident to the proximal-most first end of the patient proximal 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;

b) inflating an intralumenal balloon in the patient proximal end of the waste collection catheter to the extent that the intralumenal balloon extends slightly beyond the proximal-most end of the catheter, to thereby provide a curved tip for ease of introduction of the catheter into the patient'"'"'s rectum (c) inserting the patient proximal first end of the waste collection catheter into the patient'"'"'s rectum sufficiently far that the selectively collapsible, substantially spherical retention balloon is entirely within the patient'"'"'s rectum; and

(d) securing the waste collection catheter in the position to which it has been inserted so that the catheter does not become separated from the patient during an extended period of time, in the range of hours, while the patient'"'"'s body waste is permitted to drain out of the patient'"'"'s body through the waste collection catheter; and

(e) deflating the intralumenal balloon in the patient proximal end of the waste collection catheter to permit free flow of body wastes from the patient.

24. The method of claim 22, wherein securing the waste collection catheter in the position to which it has been inserted includes the step of inflating the substantially spherical retention balloon so that the ratio of balloon length-to-diameter is in the range of about 0.75 to about 0.61.

25. A method for managing an incontinent patient'"'"'s bowel, the method comprising:

(a) providing a bowel management system, the system having;

a waste collection catheter having at least two distinct sections of varying durometer hardness including;

a first section which is patient proximal and which is disposed in the patient'"'"'s rectum in range of about 50A to about 90A, so that the catheter patient proximal section is stiff normal use position, having a first end and a second end, and a durometer hardness in the enough to automatically maintain an open position for free flow of bowel waste when in normal use position with retention balloon inflated, yet is soft and pliable enough to permit folding longitudinally for ease of insertion into the rectum of a patient;

a second section having a first end connected to the second end of the patient proximal section, and a second end, and a durometer hardness in the range of about 5A to about 49A, so that the second section can be positioned and retained in the anal canal of the patient for extended periods without distending the sphincters or causing discomfort; and

a selectively collapsible, substantially spherical retention balloon attached coaxially and exterior of the patient proximal first catheter section such that the proximal-most end of the retention balloon is coincident to the proximal-most first end of the patient proximal 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;

(b) inserting the first section of the waste collection catheter into the patient'"'"'s rectum;

(c) connecting an end opposite the first section of the waste collection catheter to a waste collection vessel;

(d) confirming patentcy of the waste collection catheter;

(e) permitting body wastes to flow through the waste collection catheter into the waste collection container;

(f) emptying the waste collection container from time to time as necessary when the waste collection container becomes filled.

26. The method of claim 25, and further comprising, securing the first section of the waste collection catheter in position by attaching the waste collection catheter to the patient with one or more connection devices.

27. The method of claim 26, wherein the first section of the waste collection catheter is secured in position by attaching the catheter to the patient with strips of tape.

28. The method of claim 25, wherein the first section of the waste collection catheter is secured in position internally of the patient by inflating the inflatable substantially spherical balloon that is attached around the patient proximal first end of the waste collection catheter to the point where the balloon length-to-diameter ratio is in the range of about 0.75 to about 0.61.

29. The method of claim 25, and further comprising irrigating the patient'"'"'s bowel by providing an intralumenal balloon mounted to the patient proximal end of the waste collection catheter and a lumened member, wherein the lumened member has 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 collapse the retention balloon as necessary for insertion, retention or removal of the rectal catheter patient proximal first segment to or from the patient'"'"'s rectum, the second lumen being in fluid communication with the inside of the patient proximal first segment of the waste collection catheter, to thereby permit introduction of substances to the patient'"'"'s rectum, and the third lumen being in fluid communication with the intralumenal balloon;

providing a further section to the waste collection catheter, the further section having a port therein;

infusing sufficiently large volumes of fluid into the system to permit irrigation of the patient'"'"'s bowel and rinsing of the catheter from time to time, as necessary;

inflating the intralumenal balloon to retain the fluid within the patient'"'"'s bowel, and after a predetermined interval;

releasing the irrigation fluid by deflating the intralumenal balloon and permitting the fluid to flow through the waste collection catheter into a waste collection vessel.

30. The method of claim 25, and further permitting the patient'"'"'s body wastes to flow into a waste collection vessel having a size of at least approximately three liters.

31. The method of claim 25, and further comprising providing the system with a lumened member which is substantially smaller in diameter than the waste collection catheter and which has a first end and a second end, the first end of the lumened member being connected to the patient proximal first section of the waste collection catheter and 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 rectal catheter patient proximal segment to or from the patient'"'"'s rectum, wherein the lumened member has at least two independent lumens, each of the lumens being connectable at the second end of the lumened member to a port for introduction or removal of fluid from the system, one of the two lumens being in fluid communication with the first end of the patient proximal segment of the waste collection catheter, to thereby permit introduction of fluid treatment substances to the patient'"'"'s rectum;

and introducing fluid treatment substances to the patient'"'"'s bowel via the lumened member.

32. The method of claim 31, and further comprising retaining the introduced treatment substances in the patient'"'"'s bowel for a selected period of time by, providing an intralumenal balloon mounted to the patient proximal end of the waste collection catheter and, after introducing the treatment substances;

inflating the intralumenal balloon to block the interior of the catheter; and

then, after the selected period of time, deflating the intralumenal balloon to permit passage of fluids from the patient'"'"'s bowel.

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

a waste collection catheter having at least two distinct sections of varying durometer hardness including;

a first section which is patient proximal and which is disposed in the patient'"'"'s rectum in normal use position, having a first end and a second end, and a durometer hardness in the range of about 50A to about 90A, so that the catheter patient proximal section is stiff enough to automatically maintain an open position for free flow of bowel waste when in normal use position with a retention balloon inflated, yet is soft and pliable enough to permit folding longitudinally for ease of insertion into the rectum of the patient;

a second section having a first end connected to the second end of the patient proximal section, and a second end, and a durometer hardness in the range of about 5A to about 49A, so that the second section can be positioned and retained in the anal canal of the patient for extended periods without distending the sphincters or causing discomfort; and

a selectively collapsible, substantially spherical retention balloon attached coaxially and exterior of the patient proximal first catheter section such that the proximal-most end of the retention balloon is coincident to the proximal-most first end of the patient proximal 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, and further comprising a lumened member which is substantially smaller in diameter than the waste collection catheter and which has a first end and a second end, the first end of the lumened member being connected to the patient proximal first section of the waste collection catheter and 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 rectal catheter patient proximal segment to or from the patient'"'"'s rectum.

34. The system of claim 33, wherein the lumened member has at least two independent lumens, each of the lumens being connectable at the second end of the lumened member to a port for introduction or removal of fluid from the system, one of the two lumens being in fluid communication with the first end of the patient proximal segment of the waste collection catheter, to thereby permit introduction of treatment substances to the patient'"'"'s rectum.

35. The system of claim 33, wherein the retention balloon has an inflated length-to-diameter ratio in the range of about 0.75 to about 0.61, with a volume of about 44 cc to about 69 cc.

36. The system of claim 35, wherein the retention balloon has a length of 1.35 inches and a diameter of 1.8 inches.

37. The system of claim 35, wherein the retention balloon has a length of 1.35 inches and a diameter of 2.32 inches.

38. The system of claim 33, and further comprising an intralumenal balloon mounted to an interior of the patient proximal first segment of the waste collection catheter.

39. The system of claim 38, wherein the intralumenal balloon is in fluid communication with a lumen of the lumened member to thereby permit selective inflation and deflation of the intralumenal balloon and to function as an anti-reflux device.

40. The system of claim 34, and further comprising an intralumenal balloon mounted to the patient proximal end of the waste collection catheter, wherein the lumened member has 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 collapse the retention balloon as necessary for insertion, retention or removal of the rectal catheter patient proximal first segment to or from the patient'"'"'s rectum, the second lumen being in fluid communication with the inside of the patient proximal first segment of the waste collection catheter, to thereby permit introduction of substances to the patient'"'"'s rectum, and the third lumen being in fluid communication with the intralumenal balloon.

41. The system of claim 33, and further comprising a third section of the waste collection catheter, which is positioned patient distal in normal use.

42. The system of claim 41, wherein the third section of the waste collection catheter is coated internally with a substance to facilitate flow-through of waste matter from the patient.

43. The system of claim 41, wherein the patient distal third section of the waste collection catheter is coated externally with a substance to facilitate “

milking”

of the waste collection catheter by a caretaker for the patient.

44. The system of claim 41, wherein the patient distal third section of the collection catheter is coated internally with a substance to facilitate flow-through of waste matter from the patient and coated externally with a substance to facilitate “

milking”

of the waste collection catheter by a caretaker for the patient.