Fecal management appliance and method and apparatus for introducing same

• US 20050054996A1
• Filed: 08/28/2004
• Published: 03/10/2005
• Est. Priority Date: 09/09/2003
• Status: Active Grant

• Current Assignee: Convatec Technologies, Inc. (ConvaTec Group Plc)
• Original Assignee: Convatec Technologies, Inc. (ConvaTec Group Plc)
• Inventors: Gregory, Christopher C.
• Granted Patent: US 8,016,816 B2
• Time in Patent Office: Days
• US Class Current: 604/317
• CPC Class Codes: A61F 5/442 having irrigation ports or means irrigators A61M3/02
• CPC Class Codes: A61F 5/445 Colostomy, ileostomy or urethrostomy devices A61F5/441, A61F5/442, A61F5/443 take precedence
• CPC Class Codes: A61M 2210/1064 Large intestine
• CPC Class Codes: A61M 25/0119 Eversible catheters
• CPC Class Codes: A61M 3/0283 with at least two inner passageways, a first one for irrigating and a second for evacuating suction-irrigation systems A61M1/77; aspiration tips with fluid supply means A61M1/85; for negative pressure wound therapy A61M1/92
• CPC Class Codes: A61M 3/0295 with inflatable balloon
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

The end of the elongated tubular element of the appliance that is designed to be inserted into a body cavity or vessel is formed entirely of soft, compliant material. That end carries an inflatable balloon formed in its fully inflated shape. The balloon is inflated to a predetermined low pressure level to prevent pressure necrosis in the adjacent tissue. A method and apparatus for introducing the soft end of the appliance into the body cavity are also provided. The introducer apparatus includes rigid core surrounded by a soft, compliant sleeve. The sleeve extends beyond the rigid core to form an invertable section. The soft end of the appliance is situated adjacent the apparatus, the balloon is wrapped around the apparatus, and the sleeve section is inverted over the appliance, compressing the balloon and forming a soft, rounded insertion tip. The unit is then introduced into the body cavity. After the appliance is separated from the apparatus, the apparatus is withdrawn.

Claims

1. A waste management appliance for the rectum or stoma comprising an elongated tubular element having a distal end and a proximal end;

an inflatable balloon surrounding said distal element end;

an externally accessible inflation lumen operably connected to said balloon;

a waste collection receptacle; and

means for detachably mounting said receptacle to said proximal element end, wherein said distal element end is formed entirely of soft, compliant material.

2. The appliance of claim 1 wherein said material is silicone.

3. The appliance of claim 1 further comprising means for inflating said balloon to a predetermined maximum pressure.

4. The appliance of claim 1 wherein said balloon is formed entirely of soft, compliant material.

5. The appliance of claim 1 wherein said balloon is formed in its fully inflated shape.

6. The appliance is claim 1 wherein said balloon is formed of silicone.

7. The appliance of claim 1 wherein said tubular element comprises a wall and wherein at least a portion of said inflation lumen is attached to said wall.

8. The appliance of claim 1 wherein said tubular element comprises a wall with an interior surface and wherein at least a portion of said inflation lumen is integral with said interior wall surface.

9. The appliance of claim 1 wherein said tubular element comprises a wall with an opening through which said inflation lumen extends.

10. The appliance of claim 1 further comprising an externally accessible irrigation lumen having an end proximate said distal element end.

11. The appliance of claim 10 wherein said element comprises a wall and wherein at least a portion of said irrigation lumen is attached to said wall.

12. The appliance of claim 10 wherein said element comprises a wall with an interior surface and wherein at least a portion of said irrigation lumen is integral with interior wall surface.

13. The appliance of claim 10 wherein said tubular element comprises a wall with an opening through which said irrigation lumen extends.

14. The appliance of claim 1 wherein said inflation lumen extends substantially the entire length of said element.

15. The appliance of claim 10 wherein said irrigation lumen extends substantially the entire length of said element.

16. The appliance of claim 1 wherein said element has a wall and wherein said inflation lumen is attached to said wall along substantially the entire length thereof.

17. The appliance of claim 1 wherein said element has a wall with an interior surface and wherein said inflation lumen is attached to said interior wall surface along substantially the entire length of said element.

18. The appliance of claim 1 further comprising means for supplying inflation fluid to said inflation lumen.

19. The appliance of claim 18 wherein said inflation supply means comprises a syringe.

20. The appliance of claim 19 wherein said syringe comprises a plunger and a spring or spring mechanism.

21. The appliance of claim 1 wherein said inflation lumen has a section situated within said element and a section external to said element.

22. The appliance of claim 10 wherein said irrigation lumen has a section situated within said element and a section external to said element.

23. The appliance of claim 3 wherein such inflating means comprises a pressure gauge.

24. The appliance of claim 10 further comprising means for supplying irrigation fluid to said irrigation lumen.

25. The appliance of claim 1 wherein said receptacle mounting means comprises a plate with an opening and means for attaching said proximal end of said element to said plate, in alignment with said plate opening.

26. The appliance of claim 25 wherein said attaching means comprises means for permitting rotation of said proximal element end relative to said plate.

27. The appliance of claim 26 wherein said rotation permitting means comprises a first part adapted to receive said proximal element end and a second part mounted on said plate, said first part being rotatably mounted to said second part.

28. The appliance of claim 25 wherein said plate further comprises means for retaining said inflation lumen.

29. The appliance of claim 10 wherein said receptacle mounting means comprises a plate with an opening and means for attaching said proximal end of said element to said plate in alignment with said plate opening.

30. The appliance of claim 29 wherein said plate further comprises means for retaining said irrigation lumen.

31. The appliance of claim 25 for use with a stationary member, further comprising means for attaching said plate to said stationary member.

32. The appliance of claim 25 wherein said receptacle mounting means comprises first and second inter-engagable coupling parts.

33. The appliance of claim 32 wherein said first coupling part is fixed to said plate surrounding said plate opening.

34. The appliance of claim 32 wherein said receptacle comprises a wall with an opening and wherein said second coupling part is fixed to said receptacle wall surrounding said wall opening.

35. The appliance of claim 33 wherein said receptacle comprises a wall with an opening and wherein said second coupling part is fixed to said receptacle wall surrounding said wall opening.

36. The appliance of claim 1 wherein such distal end of said element adapted to be introduced into a body cavity, further comprising introducer apparatus separate from said appliance.

37. The appliance of claim 36 wherein said introducer apparatus comprises a substantially rigid elongated core having a distal end and a proximal end, and a sleeve having a distal end and a proximal end, said core being received some distance within said sleeve, with a section of said distal end of said sleeve extending beyond said distal end of said core, said sleeve section being invertable to engage said appliance.

38. The appliance of claim 37 wherein said sleeve is attached to said core.

40. The appliance of claim 37 wherein said section of said sleeve is formed of soft, compliant material.

41. The appliance of claim 1 further comprising a coating of friction-reducing material.

42. The appliance of claim 1 further comprising a coating of gas and odor barrier material.

43. The appliance of claim 41 wherein said coating is a few microns thick.

44. The appliance of claim 42 wherein said coating is a few microns thick.

39. The appliance of 37 wherein said section of said sleeve has a substantially bulbous shape.

45. Apparatus for introducing the soft end of a medical appliance into a body cavity, the apparatus comprising a substantially rigid elongated core having a distal end and a proximal end, and a sleeve having a distal end and a proximal end, said core being received within said sleeve, with a section of said distal end of said sleeve extending beyond said distal end of said core, said sleeve section being invertable to engage the soft end of the appliance.

46. The appliance of claim 45 wherein said sleeve is attached to said core.

48. The appliance of claim 45 wherein said section of said sleeve is formed of soft, complaint material.

47. The appliance of 45 wherein said section of said sleeve has a substantially bulbous shape

49. A method for introducing the distal end of a medical appliance into a body cavity utilizing introducer apparatus with a substantially rigid core and a sleeve section extending beyond the core, the method comprising the steps of placing the distal end of the medical appliance adjacent the apparatus, proximate the sleeve section, inverting the sleeve section over the distal end of the medical appliance to engage same, introducing the end of the apparatus with the inverted sleeve section and engaged end of the medical appliance into the body cavity, separating the appliance from the apparatus and withdrawing the apparatus.

50. The method of claim 49 further comprising the step of wrapping the distal end of the medical appliance around the apparatus before inverting the sleeve section.

51. The method of claim 49 wherein the distal end of the medical appliance includes a balloon, further comprising the step of wrapping the balloon around the apparatus before inverting the sleeve section.

52. The method of claim 49 wherein the introducer apparatus comprises a sleeve of which the sleeve section forms a part, further comprising the steps of inserting the rigid core into the sleeve and affixing said core to said sleeve

53. The method of claim 49 wherein the medical appliance includes an inflatable balloon at the distal end, further comprising the step of inflating the balloon, after the end of the apparatus with the inverted sleeve section and engaged end of the medical appliance is introduced into the body cavity, to cause the sleeve section to return to its non-inverted position, separating the appliance from the apparatus.

54. The method of claim 49 further comprising the step of coating the surface of the appliance with a friction-reducing material.

55. The method of claim 49 further comprising the step of coating the surface of the appliance with gas and odor barrier material.

56. The method of claim 54 wherein the step of coating comprises vacuum depositing.

57. The method of claim 55 wherein the step of coating comprises vacuum depositing.