Apparatus and methods for occluding an access tube anastomosed to sidewall of an anatomical vessel

• US 7,131,959 B2
• Filed: 01/23/2003
• Issued: 11/07/2006
• Est. Priority Date: 01/23/2003
• Status: Expired due to Fees

• Current Assignee: DF Vital Holdings, LLC
• Original Assignee: Integrated Vascular Interventional Technologies LC (Integrated Vascular Interventional Technologies)
• Inventors: Barrus, Michael C., Blatter, Duane D., Orr, Troy J.
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): Deak, Leslie R.
• Application Number:
  US10/351,172
• Publication Number:
  US 20040147866A1
• Time in Patent Office: 1,384 Days
• Field of Search: 604/4.01, 604/5.01, 604/6.05, 604/6.06, 604/6.1, 604/6.16, 604 7- 10, 604/27, 604/28, 604/43, 604/175, 604506-509, 604/5.04, 604/21, 604 32- 34, 604/96.01, 604/101.04, 604/103.07, 604/288.1, 604/891.1, 604/103.01, 604/30, 604/93.01, 604/264, 606/153, 606/157, 606/139, 623/1.13, 623/1.36, 623/1.25, 623/1.24, 623/1.42, 210/600, 210/645, 210/646
• US Class Current: 604/6.16
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 1/3661 for haemodialysis

Abstract

The invention provides vascular access methods, systems and devices facilitating long-term, repeated, percutaneous access to a patient'"'"'s blood stream. This is provided by an access tube apparatus adapted for anastomosis to the sidewall of a target anatomical vessel. The access tube has a replaceable occluder that fits within the conduit of the access tube in between blood treatments or when vascular access is otherwise not needed. When such access is desired, the percutaneously accessible occluder is simply removed from the access tube.

Claims

1. A method for percutaneously and repeatedly accessing a body fluid such as blood in an anatomical vessel, comprising:

obtaining an access tube having an access end and an anastomosis end with a conduit extending from the access end to the anastomosis end;

anastomosing the anastomosis end of the access tube to the sidewall of an anatomical vessel, wherein the access tube has sufficient length so that the access tube extends percutaneously with the access end being extracorporeally positioned;

occluding the conduit of the access tube with an occluder at the anastomosis end;

removing the occluder to provide fluid communication between the lumen of the anatomical vessel and the conduit of the access tube;

re-occluding the conduit of the access tube; and

flushing the conduit with a flushing fluid after the conduit of the access tube has been re-occluded.

2. The method of claim 1, wherein the occluder has an exposed portion that is exposed to the lumen and in contact with body fluid in the lumen once the occluder is positioned in the conduit;

and wherein the anastomosing and occluding steps are achieved with configurations that result in minimal contact between the body fluid and materials other than the native vessel walls once the conduit is occluded as only the exposed portion of the occluder is in significant contact with the fluid during occlusion.

3. The method of claim 2, wherein the occluder abuts the vessel wall when the occluder is in its occluding position such that the exposed portion of the occluder extends all the way to the end of the access tube conduit and is approximately flush with the vessel wall.

4. The method of claim 1, wherein the occluder has an exposed portion that is exposed to the lumen and in contact with body fluid in the lumen once the occluder is positioned in the conduit;

and wherein the surface area of the exposed portion is primarily determined by the circumference of the conduit.

5. The method of claim 1, wherein the anastomosing is done by suturing.

6. The method of claim 1, wherein reoccluding the conduit comprises replacing the occluder with another occluder.

7. The method of claim 1, further comprising providing fluid communication between the conduit of the access tube and a blood treatment device.

8. The method of claim 7, further comprising providing fluid communication between the blood treatment device and a second access tube anastomosed to a second vessel to re-introduce the treated blood.

9. The method of claim 7, further comprising providing fluid communication between the blood treatment device and a second access tube anastomosed to the vessel at another location to re-introduce the treated blood.

10. The method of claim 7, further comprising re-introducing the treated blood back through the conduit of the access tube.

11. The method of claim 1, further comprising replacing a portion of the occluder with a new portion, wherein at least a portion of the replaced portion is exposed to flow in the vessel.

12. The method of claim 1, further comprising flushing out the portion of the access tube conduit between the occluder and the interior conduit wall with a flushing fluid while the occluder is positioned in the conduit.

13. The method of claim 12, wherein the flushing fluid is an antibacterial solution.

14. The method of claim 1, wherein the occluder has an exposed portion that is exposed to the lumen and in contact with body fluid in the lumen once the occluder is positioned in the conduit;

and wherein the exposed portion of the occluder is coated with a pharmacological substance.

15. The method of claim 14, wherein the pharmacological substance elutes a pharmacological agent at the exposed portion of the occluder.

16. The method of claim 14, wherein the pharmacological substance comprises at least one of an anticoagulant agent, an antimicrobial agent, an antiproliferative agents.

17. A method for percutaneously and repeatedly accessing a body fluid such as blood in an anatomical vessel, comprising:

obtaining an access tube having an access end and an anastomosis end with a conduit extending from the access end to the anastomosis end;

anastomosing the anastomosis end of the access tube to the sidewall of an anatomical vessel, wherein the access tube has sufficient length so that the access tube extends percutaneously with the access end being extracorporeally positioned;

occluding the conduit of the access tube at the anastomosis end with an occluder after the anastomosis end of the access tube has been anastomosed to the sidewall of the anatomical vessel;

removing the occluder to provide fluid communication between the lumen of the anatomical vessel and the conduit of the access tube;

providing fluid communication between the access end of the access tube and a device to enable a fluid to flow from the conduit of the access tube to the device;

re-occluding the conduit of the access tube; and

flushing the conduit with a flushing fluid after the conduit of the access tube has been re-occluded.

18. The apparatus of claim 17, wherein the occluder has an occlusion end having an exposed portion that is exposed to the lumen of the vessel and in contact with body fluid in the lumen once the occluder is positioned in the conduit, and wherein the surface area of the exposed portion is primarily determined by the circumference of the conduit.

19. An apparatus for facilitating repeated percutaneous access to a body fluid such as blood in an anatomical vessel, comprising:

an access tube having an access end and an anastomosis end with a conduit extending from the access end to the anastomosis end, wherein the anastomosis end is configured to be attached to the sidewall of a vessel at an anastomosis opening, and wherein the access end is configured to extend percutaneously and be extracorporeally accessible; and

an occluder configured to fit within the access tube conduit to control fluid flow between the anatomical vessel and the access tube, wherein the occluder is removable from the conduit while the access tube remains attached to the vessel;

wherein the apparatus is configured to enable a flushing fluid to be delivered into the access tube after the access tube has been re-occluded by the occluder.

20. The apparatus of claim 19, wherein the occluder has an exposed portion at its occlusion end that is in contact with body fluid in the lumen once the occluder is positioned in the conduit.

21. The apparatus of claim 20, wherein the occluder is configured such that there is minimal contact between the body fluid and materials other than the native vessel walls once the conduit is occluded as only the exposed portion of the occluder is in significant contact with the body fluid during occlusion.

22. The apparatus of claim 19, wherein the access tube further comprises a component of an anastomosis device at the anastomosis end of the access tube.

23. The apparatus of claim 22, wherein the component is an anastomosis ring.

24. The apparatus of claim 19, wherein the occluder has a stemmed portion such that the occluder has a larger diameter at its occlusion end than at the stemmed portion of the occluder.

25. The apparatus of claim 19, wherein occluder is uniformly-shaped.

26. The apparatus of claim 19, wherein the conduit has a tapered diameter that is slightly smaller at the anastomosis end than at the access end such that a tighter seal is maintained between the conduit and the occluder at the anastomosis end than at the access end.

27. The apparatus of claim 19, wherein the occluder has a sealing lip extending circumferentially around at least a portion of the occluder, and wherein the sealing lip has a diameter greater than the diameter of other portions of the occluder fitting inside the conduit.

28. The apparatus of claim 27, wherein the conduit is flexible such that its diameter can be stretched beyond a resting diameter, wherein the resting diameter of the conduit is the diameter at times during which the conduit is not subjected to stretching forces.

29. The apparatus of claim 28, wherein the sealing lip has a diameter larger than the resting diameter of the conduit such that the sealing lip forms a bulge around the conduit when the occluder is inside the conduit.

30. The apparatus of claim 19, wherein the access end of the access tube is connectable to a control end of the occluder.

31. The apparatus of claim 19, wherein the occluder has a channel contained therein, wherein the channel has a first opening and a second opening, and wherein the channel is configured to enable the flushing fluid to be introduced through the first opening and to flow out of the second opening to flush out the portion of the conduit between the occluder and an interior conduit wall.

32. The apparatus of claim 19, wherein the occluder is configured to avoid extending significantly into the vessel lumen.

33. The apparatus of claim 20, wherein the occluder is configured to abut the vessel wall when the occluder is in its occluding position such that the exposed portion of the occlusion end is approximately flush with the surrounding vessel wall.

34. The apparatus of claim 19, further comprising a pharmacological coating on the occluder.

35. The apparatus of claim 34, wherein the pharmacological coating includes an antiproliferative agent.

36. The apparatus of claim 19, further comprising a pharmacological coating on one or more surfaces inside the conduit of the access tube.

37. An apparatus for facilitating repeated percutaneous access to a body fluid such as blood in an anatomical vessel, comprising:

access tube means for accessing an anastomosed vessel, wherein the access tube means has an access end and an anastomosis end with a conduit extending from the access end to the anastomosis end, wherein the anastomosis end is configured to be attached to the sidewall of a vessel, and wherein the access end is configured to extend percutaneously and be extracorporeally accessible; and

occluding means for blocking fluid communication between the vessel and the access tube, wherein the occluding means can be selectively removed from the access tube means to allow for fluid communication between the vessel and the access tube means;

wherein the apparatus is configured to enable a flushing fluid to be delivered into the access tube means after the access tube means has been re-occluded by the occluding means.

38. The apparatus of claim 37, wherein the occluding means is configured to allow for minimal contact between the body fluid and materials other than the native vessel walls once the conduit is occluded as only an exposed portion of the occluding means is in significant contact with the body fluid during occlusion.

39. The apparatus of claim 38, wherein the exposed portion of the occluding means is replaceable.

40. The apparatus of claim 37, further comprising at least one means for facilitating anastomosis of the access tube means to an anatomical vessel.

41. The apparatus of claim 40, wherein the at least one means for facilitating anastomosis of the access tube means to an anatomical vessel is an anastomosis ring.

42. The apparatus of claim 37, wherein the occluding means has a sealing portion having a diameter greater than the diameter of other portions of the occluding means.

43. The apparatus of claim 37, wherein the access end of the access tube means is connectable to the occluding means.

44. The apparatus of claim 37, wherein the occluding means has a channel contained therein, wherein the channel has a first opening and a second opening and wherein the channel is configured to enable the flushing fluid to be introduced through the first opening and to flow out of the second opening to flush out the portion of the conduit between the occluding means and an interior conduit wall.

45. The apparatus of claim 37, further comprising means for preventing infection in the access tube means.

46. The apparatus of claim 37, further comprising means for preventing complications at the anastomosis site.

47. The apparatus of claim 46, wherein the means for preventing complications comprises a pharmacological coating on the occluding means.