Implantable digestive tract organ

• US 7,141,071 B2
• Filed: 12/23/2002
• Issued: 11/28/2006
• Est. Priority Date: 12/23/2002
• Status: Active Grant

• Current Assignee: Python Medical, Inc.
• Original Assignee: Python Medical, Inc.
• Inventors: Imran, Mir A.
• Primary Examiner(s): Stewart, Alvin J.
• Application Number:
  US10/328,446
• Publication Number:
  US 20040122527A1
• Time in Patent Office: 1,436 Days
• Field of Search: 623 2364- 237, 623/11.11, 606191-192, 606/151, 606/157, 600/37
• US Class Current: 623/23.64
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/482 Electrical means
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2250/008 Alarm means
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers

Abstract

An implantable digestive organ is provided for the transport of materials through the digestive tract and in one particular application to an artificial large bowel for replacing all or part of a colon or large bowel. The prosthetic organ of one embodiment includes an outer support structure, an expandable member or members located within the outer support structure, and a flexible inner member forming a conduit for the passage of material. The flexible inner member is located within the outer member and the expandable member or members are located between the inner member and the outer support structure. The expandable members are expanded and contracted, or inflated and deflated to provide a pumping action that pumps the material through the organ. The prosthesis may also include valves or sphincters at the entrance and/or exit points of the organ where material moves into and out of the prosthesis. An implantable pump unit may be included for inflating and deflating the expandable members according to a desired sequence.

Claims

1. An implantable prosthetic digestive organ adapted for moving materials through a portion of a patient'"'"'s digestive tract comprising:

an outer support structure;

at least one expandable member located within the outer support structure; and

a flexible inner member forming a conduit for the movement of material therethrough, the flexible inner member located within the outer member, wherein the least one expandable member is located between the inner member and the outer support structure wherein the outer support member has a length, and wherein the at least one expandable member comprises a plurality of expandable members located along the length of the outer support member, and

wherein the plurality of expandable members comprise a plurality of opposing inflatable member pairs located along the length of the outer support member.

2. The implantable prosthetic organ of claim 1 wherein the plurality of expandable members comprise a plurality of opposing expandable members wherein each of the plurality of opposing members are staggered a distance along the length of the prosthesis from the other of the plurality of opposing member pairs.

3. The implantable prosthetic organ of claim 1 wherein the plurality of expandable members are arranged in a spiraling relationship along the length of the prosthesis.

4. The implantable prosthetic organ of claim 1 wherein the at least one expandable member comprises a U-shaped member.

5. An implantable prosthetic digestive organ comprising a device adaptedfor moving materials through a portion of a patient'"'"'s digestive tract comprising:

an outer support structure;

at least one expandable member located within the outer support structure; and

a flexible inner member forming a conduit for the movement of material therethrough, the flexible inner member located within the outer member, wherein the least one expandable member is located between the inner member and the outer support structure wherein the outer support member has a length, and wherein the at least one expandable member comprises a plurality of expandable members located along the length of the outer support member, and

wherein the plurality of expandable members are arranged to be expanded in a controlled sequence after the implantation of the digestive organ.

6. An implantable prosthetic digestive organ adapted for moving materials through a portion of a patient'"'"'s digestive tract comprising:

an outer support structure;

at least one expandable member located within the outer support structure; and

a flexible inner member forming a conduit for the movement of material therethrough, the flexible inner member located within the outer member, wherein the least one expandable member is located between the inner member and the outer support structure wherein the outer support member has a length, and wherein the at least one expandable member comprises a plurality of expandable members located along the length of the outer support member, and

a controller configured to control the expansion of the plurality of expandable members according to a sequence.

7. The implantable prosthetic organ of claim 6 wherein the prosthetic organ comprises a plurality of sections of expandable members and wherein the controller is configured to control the expansion of the expandable members of the sections according to a sequence of sections.

8. An implantable prosthetic digestive organ adapted for moving materials through a portion of a patient'"'"'s digestive tract comprising:

an outer support structure;

at least one expandable member located within the outer support structure;

a flexible inner member forming a conduit for movement of material therethrough, the flexible inner member located within the outer member, wherein the least one expandable member is located between the inner member and the outer support structure; and

a valve comprising at least one valve member configured to control the movement of the material through the organ.

9. The implantable prosthetic organ of claim 8 wherein the at least one valve member is located between the inner member and the outer support structure.

10. The implantable prosthetic organ of claim 9 further comprising an external control device arranged to communicate via telemetry with the controller, wherein the implantable prosthetic organ has an orad end and an aborad end, the implantable prosthetic organ farther comprising an aborad sphincter valve located at the aborad end, the aborad sphincter valve controllable by the controller to open and close the valve, and wherein the external control device is configured to receive the alarm signal and to generate a user perceivable alarm in response to the alarm signal, wherein the external control device farther comprises a user activated release actuable to communicate with the controller to instruct the controller to at least partially open the aborad sphincter valve.

11. The implantable prosthetic organ of claim 8 wherein the prosthesis comprises an orad end portion and wherein the valve is located at the orad end portion and is configured to control the movement of material into the organ.

12. The implantable prosthetic organ of claim 11 wherein the valve is a prosthetic ileocecal valve.

13. The implantable prosthetic organ of claim 8 wherein the prosthesis comprises an aborad end portion and wherein the valve is located at the aborad end portion and is configured to control the movement of material out of the organ.

14. The implantable prosthetic organ of claim 13 wherein the valve is a prosthetic rectal sphincter.

15. An implantable prosthetic digestive organ adapted for moving materials through a portion of a digestive tract of a patient comprising:

an outer support structure;

at least one expandable member located within the outer support structure; and

a flexible inner member forming a conduit for the movement of material therethrough, the flexible inner member located within the outer member, wherein the least one expandable member is located between the inner member and the outer support structure,

wherein the prosthetic organ comprises an implantable bowel adapted for replacing a portion of the patient'"'"'s large bowel, and

wherein the outer support structure comprises an outer support tube having a length.

16. An implantable prosthetic digestive organ adapted for moving materials through a portion of a patient'"'"'s digestive tract comprising:

an outer support structure;

a flexible inner member forming a conduit for the movement of material therethrough, the flexible inner member located within the outer support structure; and

a valve comprising at least one expandable member located between the inner member and the outer support structure, wherein expansion of the at least one expandable member moves the valve toward a closed position.

17. The implantable prosthetic organ of claim 16 wherein the valve comprises expandable members configured to close the inner member in an S-shaped configuration.

18. The implantable prosthetic organ of claim 17 wherein the valve comprises a one way valve that is configured to open to permit substance to move in a first direction to enter into the inner member of the prosthesis while resisting movement of substance in an opposite direction out of the inner member.

19. The implantable prosthetic organ of claim 18 wherein the valve comprises a low pressure valve that permits passage of material therethrough when a threshold relatively pressure has been applied at a location where substance moves in the first direction to enter the inner member.

20. The implantable prosthetic organ of claim 16 wherein the valve comprises a plurality of inflated members inflated to a threshold pressure to be met to permit movement of substance through the valve into the inner member.

21. The implantable prosthetic organ of claim 16 wherein the organ has an orad end and an aborad end, wherein the valve is located at the orad end and comprises a plurality of members coupled to the outer member and extending in an aborad direction from its coupling to the outer member.

22. The implantable prosthetic organ of claim 16 wherein the valve comprises a two stage valve wherein a first stage comprises a first valve that permits passage of material therethrough when a threshold pressure has been applied to open the valve, and wherein a second stage comprises a high pressure valve preventing passage of material therethrough when the high pressure valve is actuated.

23. The implantable prosthetic organ of claim 16 wherein the prosthetic organ is an implantable bowel having an orad end and an aborad end, the implantable bowel further comprising a rectal sphincter valve located at the aborad end.

24. The implantable prosthetic organ of claim 16 wherein the prosthetic organ is an implantable bowel having an orad end and an aborad end, the implantable bowel further comprising a orad valve located at the orad end.

25. The implantable prosthetic organ of claim 24 wherein the orad valve comprises a plurality of inflated members inflated to a threshold pressure to be met to permit movement of substance through the orad valve into the inner member.

26. An implantable prosthetic digestive organ adapted for moving materials through a portion of a patient'"'"'s digestive tract comprising:

an outer support member;

at least one expanding member located within the outer support member; and

a flexible inner member forming a conduit for the movement of material therethrough, the flexible inner member located within the outer member, wherein the least one expanding member is located between the inner member and the outer support structure,

wherein the expanding member is configured to expand so as to push material through a portion of the implantable digestive organ.

27. The implantable prosthetic organ of claim 26 wherein the outer support member has a length, and wherein the at least one expanding member comprises a plurality of expanding members located along the length of the outer support member.

28. The implantable prosthetic organ of claim 27 wherein the plurality of expanding members comprise a plurality of opposing inflatable member pairs located long the length of the outer support member.

29. The implantable prosthetic organ of claim 27 wherein the plurality of expanding members are arranged to be expanded in a sequence.

30. The implantable prosthetic organ of claim 27 further comprising a controller configured to control the expansion of the plurality of expanding members according to a sequence.

31. The implantable prosthetic organ of claim 30 wherein the prosthetic organ comprises a plurality of sections of expanding members and wherein the controller is configured to control the expansion of the expanding members of the sections according to a sequence of sections.

32. The implantable prosthetic organ of claim 26 further comprising an implantable pump wherein at least one expanding members further comprises an input port coupled to the pump, and wherein the implantable pump is configured to pump an inflation medium into the at least one expanding members through a corresponding input port to expand the at least one expanding member.

33. The implantable prosthetic organ of claim 32 wherein the outer support member has a length, and wherein the at least one expanding member comprises a plurality of expanding members located along the length of the outer support member, and wherein the implantable pump further comprises a controller configured to control delivery of inflation medium individually to and from each of the plurality of expanding members in a sequence.

34. The implantable prosthetic organ of claim 26 further comprising an external control device arranged to communicate via telemetry with the prosthetic and wherein the external control device further comprises a user activated release actuable to communicate with the prosthetic organ to actuate the prosthetic organ to inflate the at least one expanding member.

35. The implantable prosthetic organ of claim 26 wherein the implantable prosthetic further comprises a pressure sensor arranged to sense a pressure corresponding to a pressure within the inner member.

36. The implantable prosthetic organ of claim 35 wherein the pressure sensor is coupled to the controller, wherein the controller further comprises a telemetry coil arranged to communicate a telemetric signal with an external device, and wherein the controller is configured to communicate an alarm signal to the external device when a pressure sensed by the pressure sensor exceeds a threshold pressure.

37. The implantable prosthetic organ of claim 36 further comprising an external control device arranged to communicate via telemetry with the controller, and wherein the external control device is configured to receive the alarm signal and to generate a user perceivable alarm in response to the alarm signal, wherein the external control device further comprises a user activated release actuable to communicate with the controller to instinct the controller to actuate the prosthetic organ.

38. An implantable prosthetic digestive organ adapted for moving materials through a portion of a patient'"'"'s digestive tract comprising:

an outer support member;

at least one expanding member located within the outer support member; and

a flexible inner member forming a conduit for the movement of material therethrough, the flexible inner member located within the outer member, wherein the least one expanding member is located between the inner member and the outer support structure,

wherein the expanding member is configured to expand to thereby move material through a portion of the implantable digestive organ,

wherein the prosthetic organ comprises an implantable bowel for replacing a portion of the large bowel,

wherein the outer support member comprises an outer support tube having a length.

39. An implantable prosthetic digestive organ adapted for moving materials through a portion of a patient'"'"'s digestive tract comprising:

an outer support structure;

a flexible inner member forming a conduit for the movement of material therethrough, the flexible inner member located within the outer support structure; and

a valve comprising at least one expandable member located between the inner member and the outer support structure, wherein the valve comprises a plurality of inflated members inflated to a threshold pressure to be met to permit movement of substance through the valve into the inner member.

40. An implantable prosthetic digestive organ adapted for moving materials through a portion of a patient'"'"'s digestive tract comprising:

an outer support structure;

a flexible inner member forming a conduit for the movement of material therethrough, the flexible inner member located within the outer support structure; and

a valve comprising at least one expandable member located between the inner member and the outer support structure,

wherein the prosthetic organ is an implantable bowel having an orad end and an aborad end, the implantable bowel further comprising a orad valve located at the orad end.

41. The implantable prosthetic organ of claim 40 wherein the orad valve comprises a plurality of inflated members inflated to a threshold pressure to be met to permit movement of substance through the orad valve into the inner member.

42. An implantable prosthetic digestive organ adapted for moving material through a portion of a patient'"'"'s digestive tract comprising:

an outer support member;

at least one expanding member located within the outer support member; and

a flexible inner member forming a conduit for the movement of material therethrough, the flexible inner member located within the outer member, wherein the least one expanding member is located between the inner member and the outer support structure,

wherein the expanding member is configured to expand to thereby move material through a portion of the implantable digestive organ; and

a valve comprising at least one valve member configured to cause movement of material through the organ.

43. The implantable prosthetic organ of claim 42 wherein the at least one valve member is located between the inner member and the outer support member.

44. The implantable prosthetic organ of claim 42 wherein the prosthesis comprises an orad end portion and wherein the valve is located at the orad end portion and is configured to control the movement of material into the organ.

45. The implantable prosthetic organ of claim 44 wherein the valve is a prosthetic ileocecal valve.

46. The implantable prosthetic organ of claim 42 wherein the prosthesis comprises an aborad end portion and wherein the valve is located at the aborad end portion and is configured to control the movement of material out of the organ.

47. The implantable prosthetic organ of claim 46 wherein the valve is a prosthetic rectal sphincter.