Hemodialysis system and method

• US 7,144,381 B2
• Filed: 06/20/2002
• Issued: 12/05/2006
• Est. Priority Date: 06/20/2001
• Status: Expired due to Fees

• Current Assignee: Michael Gertner
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Gertner, Michael
• Primary Examiner(s): Bianco, Patricia
• Application Number:
  US10/177,721
• Publication Number:
  US 20030014003A1
• Time in Patent Office: 1,629 Days
• Field of Search: 604/4.01, 604/6.08, 604 501- 504, 604/6.16, 604/7, 604/8, 604 19- 22, 604/27, 604/890.1, 604/891.1, 210645-647, 210/696, 210/739, 210/745, 210/746, 210/748, 210/194, 2101951-1952, 210/252, 210/257.1, 210/257.2, 210/321.6, 210/321.71, 210/321.72, 600437-439, 600/454, 600458- 9, 600461- 2, 600/464, 600466-470, 600/11, 600/15, 606/1, 606/8, 606/10, 606 32- 34, 606/108, 606/127, 606/128, 606/195, 606/110, 607 1- 3, 607/44, 607/60, 607/61, 607/80, 607/88, 607/90, 607/94, 607 96-101, 607104-106
• US Class Current: 604/5.01
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/36 Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
• 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
• CPC Class Codes: A61M 1/3672 Means preventing coagulation
• CPC Class Codes: A61M 1/3673 Anticoagulant coating, e.g. Heparin coating

Abstract

A treatment assembly is positioned along an AV-fistula and couples therapeutic energy to an adjacent area due to a material response to an applied energy field from a remotely located energy source. The treatment assembly may be delivered into the fistula through a hemodialysis needle, or may be secured to the fistula graft itself and implanted therewith within a patient. A cover provides a shield between an anastomosis area and blood flow. Another AV-fistula includes a valved reservoir that receives a fluid agent from a hemodialysis needle while moving the needle into or from the fistula; the agent leaks from the reservoir into the fistula lumen. Another valved fistula is adjustable between an open condition and closed conditions during and between hemodialysis treatments, respectively. Another AV-fistula has a bladder reservoir coupled to a second refillable fluid reservoir and is adapted to locally deliver a therapeutic agent into the fistula lumen.

Claims

1. An AV-fistula treatment system, comprising:

a hemodialysis needle;

at least one treatment assembly comprising an adjustable member that is deliverable in a first configuration with a first outer diameter through the hemodialysis needle and into an AV-fistula, and the adjustable member in the first configuration also being positionable at a location along the AV-fistula;

wherein the adjustable member at the location is adjustable from the first configuration to a second configuration with a second outer diameter that is greater than the first outer diameter;

wherein the adjustable member in the second configuration at the location is actuatable so as to couple energy between the adjustable member and an area adjacent to adjustable member at the location; and

wherein the coupled energy is sufficient to provide a therapeutic affect at least in the area.

2. The system of claim 1, wherein the adjustable member is positionable at the location along one of two opposite end portions of the AV-fistula that is anastomosed to the artery or vein.

3. The system of claim 2, wherein the adjustable member is positionable at the location along the end portion that is anastomosed to the vein.

4. The system of claim 3, wherein the adjustable member is positionable at either of two locations along each of the two opposite end portions, respectively, that are anastomosed to the vein and artery, also respectively.

5. The system of claim 1, wherein the at least one treatment assembly further comprises:

first and second treatment assemblies with first and second adjustable members, respectively, that are positionable in respective first configurations with respective first outer diameters at first and second locations, respectively, along each of two opposite end portions of the AV-fistula, respectively, that are anastomosed to the vein and artery, also respectively;

wherein the first and second adjustable members are adjustable at the first and second locations to respective second configurations with respective second outer diameters that are greater than the respective first outer diameters; and

wherein the first and second adjustable members in the respective second configurations at the first and second locations, respectively, couple therapeutic energy to first and second areas, also respectively, adjacent to the first and second locations, also respectively.

6. The system of claim 1, further comprising:

a delivery member with an elongate body having a proximal end portion and a distal end portion;

wherein the treatment assembly is located along the distal end portion of the elongate body; and

wherein the treatment assembly located along the distal end portion is deliverable by the delivery member to the location through the hemodialysis needle.

7. The system of claim 6, wherein the adjustable member of the treatment assembly further comprises:

an expandable member that is expandable between a radially collapsed condition and a radially expandable condition corresponding with the first and second configurations, respectively, of the adjustable member;

wherein in the radially collapsed condition the expandable member has a first outer diameter that is adapted to be delivered to the location within a lumen of an AV-fistula graft through the hemodialysis needle;

wherein in the radially expanded condition the expandable member has a second outer diameter larger than the first outer diameter; and

wherein the treatment assembly couples energy between the expandable member in the radially expanded condition and the area adjacent the expandable member in the radially expanded condition.

8. The system of claim 7, wherein the treatment assembly couples energy between the expandable member in the radially expanded condition and a circumferential area surrounding the expandable member in the radially expanded condition.

9. The system of claim 8, wherein the expandable member comprises an inflatable balloon.

10. The system of claim 9, wherein the inflatable balloon comprises a substantially elastomeric material.

11. The system of claim 10, wherein the material is chosen from the group consisting of polyurethane, silicone, latex rubber, or combinations or blends thereof.

12. The system of claim 9, wherein the material comprises a relatively non-compliant material such that the balloon is folded in the radially collapsed condition.

13. The system of claim 9, wherein the inflatable balloon comprises a balloon wall and a material associated with the balloon wall that is responsive to an applied energy field to couple the energy to the area.

14. The system of claim 9, further comprising an inflation medium within the inflatable balloon that is responsive to an applied energy field to couple the energy to the area.

15. The system of claim 6, wherein at least the distal end portion of the delivery member is trackable over a guide wire to the location within the AV-fistula.

16. The system of claim 15, further comprising:

a guidewire with an elongate body having a proximal end portion and a distal end portion;

wherein the distal end portion of the guidewire comprises a shaped or shapeable tip;

wherein the guidewire is substantially torquable such that the tip is steerable in-vivo by manipulating the proximal end portion externally from the patient'"'"'s body; and

wherein the delivery member is slidably engagable and trackable over the guidewire to the location.

17. The system of claim 6, wherein:

the delivery member further comprises a deflection member extending from the proximal end portion of the delivery member and the distal end portion; and

wherein the distal end portion has a deflectable shape by manipulating the deflection member along the proximal end portion of the elongate body of the delivery member.

18. The system of claim 1, wherein the treatment assembly is adapted to be implanted at the location along the AV-fistula.

19. The system of claim 18:

wherein the AV-fistula comprises an AV-fistula graft with a tubular graft body;

wherein the treatment assembly is permanently secured to the graft body at the location.

20. The system of claim 19, wherein:

the tubular graft body comprises first and second opposite end portions; and

the treatment assembly comprises at least one member that is configured to extend beyond one of the two opposite end portions of the tubular graft body.

21. The system of claim 20, wherein:

the at least one member comprises a plurality of adjacent elongate members positioned around a circumference; and

wherein the at least one member is configured to extend longitudinally beyond the tubular graft body end.

22. The system of claim 21, wherein the elongate members are adapted to be positioned to cover an anastomosis between the tubular graft body end and a respective artery or vein with respect to blood flow.

23. The system of claim 22, wherein the elongate members are positioned along only a portion of the circumference.

24. The system of claim 23, wherein the portion is positioned at a location that is adapted to be on a downstream side of an anastomosis between the graft and a corresponding blood vessel.

25. The system of claim 22, wherein the elongate members are substantially pliable and deflectable under pressure of blood flow in order to cover the anastomosis region.

26. The system of claim 20, wherein the member comprises a tubular member that is configured to be implanted along the tubular graft body and extending beyond the end portion.

27. The system of claim 19, wherein the AV-fistula graft is further adapted to locally deliver a fluid agent into a region adjacent to the AV-fistula graft.

28. The system of claim 27, further comprising a reservoir coupled to the tubular graft body and that is adapted to house the fluid agent for delivery into the region.

29. The system of claim 28, wherein the reservoir is refillable.

30. The system of claim 27, wherein the AV-fistula graft is adapted to deliver the fluid agent preferentially along the end portion corresponding to the location.

31. The system of claim 27, wherein the region of localized agent delivery from the AV-fistula graft corresponds to the area of energy coupling with the treatment assembly.

32. The system of claim 19, wherein the tubular graft body has a curved shape.

33. The system of claim 19:

wherein the hemodialysis needle is adapted to penetrate the tubular wall of the AV-fistula graft; and

wherein the hemodialysis needle is adapted to allow for fluid communication between the lumen and a hemodialysis pump system.

34. The system of claim 1, wherein the treatment assembly comprises a material that exhibits a material response to an applied energy field from a remotely located energy source such that the treatment assembly is activated to couple the energy to the area.

35. The system of claim 34, wherein the material exhibits the material response to applied light energy from a remotely located light energy source.

36. The system of claim 35, wherein the material exhibits the material response to applied ultraviolet light energy from a remotely located ultraviolet light energy source.

37. The system of claim 35, wherein the material exhibits the material response to applied infrared light energy from a remotely located infrared light energy source.

38. The system of claim 34, wherein the material exhibits the material response to an applied electrical current field from a remotely located electrical current source.

39. The system of claim 34, wherein the treatment assembly is actuatable by an applied energy field applied across a skin layer of the patient from a remote energy source located externally of the patient when the treatment assembly is positioned at the location along the AV fistula extending between vein and artery anastomoses within the patient'"'"'s body.

40. The system of claim 34, wherein:

the material heats in response to energy received from the remotely located energy source; and

the treatment assembly thermally couples energy to the area as a result of the heat response of the material.

41. The system of claim 34, wherein the material exhibits the material response to an applied ultrasonic energy field from a remote ultrasound energy source.

42. The system of claim 34, wherein the material comprises a ferromagnetic material and exhibits the material response to an applied magnetic field from a remotely located inductive energy source.

43. The system of claim 1, wherein the treatment assembly is actuatable so as to couple a sufficient amount of energy between the treatment assembly and the area to substantially inhibit formation of a stenosis associated with the AV-fistula.

44. The system of claim 1, wherein the treatment assembly is actuatable to couple a sufficient amount of energy between the treatment assembly and the area to substantially remove at least a portion of a stenosis associated with the AV-fistula.

45. The system of claim 1, wherein the treatment assembly is actuatable to couple sufficient energy between the treatment assembly and the area to substantially prevent neo-intimal hyperplasia in the area.

46. The system of claim 1, wherein the treatment assembly is actuatable to couple sufficient energy between the treatment assembly and the area to substantially prevent thrombogenesis or thrombus adhesion in the area.

47. The system of claim 1, wherein the treatment assembly couples the energy between the treatment assembly and a substantially circumferential area adjacent to the treatment assembly.

48. The system of claim 47, wherein the substantially circumferential area coincides with a circumferential region of an AV-fistula circumscribing an internal lumen of the AV-fistula.

49. The system of claim 1, wherein:

the adjustable member adjustable between a first shape and a second shape corresponding with the first and second configurations, respectively.

50. The system of claim 49, wherein the adjustable member comprises a radially expandable member that is adjustable between a radially collapsed condition that characterizes the first shape and a radially expanded condition that characterizes the second shape.

51. The system of claim 50, wherein the radially expandable member comprises a radially expandable tubular member.

52. The system of claim 51, wherein the radially expandable tubular member comprises an inflatable balloon.

53. The system of claim 52, wherein the inflatable balloon comprises a substantially compliant material.

54. The system of claim 53, wherein the substantially compliant material exhibits at least 500% elongation between the radially collapsed and expanded conditions.

55. The system of claim 53, wherein the substantially compliant material is selected from the group consisting of polyurethane, latex, silicone, and derivatives, combinations, and blends thereof.

56. The system of claim 49, wherein the second outer diameter is sufficient to couple the energy between the adjustable member and a substantially circumferential area that coincides with a circumferential region of an AV-fistula wall.

57. The system of claim 1, wherein the treatment assembly couples to a remotely located energy source and is actuatable by an applied energy field from the energy source to thereby couple the energy between the treatment assembly and the area adjacent to the treatment assembly.

58. The system of claim 1, further comprising:

an energy source that is positionable at a location remote from the treatment assembly and that is configured to actuate the adjustable member of the treatment assembly; and

wherein the adjustable member of the treatment assembly is actuatable so as to couple the energy between the adjustable member and the area in response to the actuation.

59. The system of claim 58, further comprising a hemodialysis pump system that is adapted to couple to the hemodialysis needle.

60. The system of claim 1, wherein the treatment assembly is adapted to actively cool the area.

61. An AV-fistula graft treatment system, comprising:

a treatment device with a delivery member having an elongate body with a first end portion and a second end portion, and also having a treatment assembly positioned along the first end portion;

wherein the treatment assembly is positionable with the first end portion at a location within a lumen of an AV-fistula graft through a hemodialysis needle; and

wherein the treatment assembly is actuatable so as to actively cool an area adjacent to the treatment assembly sufficient to cause a therapeutic affect at the location when the AV-fistula graft is implanted within a patient and extending between first and second anastomoses between the first and second end portions, respectively, and first and second blood vessels, also respectively.

62. The system of claim 61, wherein the treatment assembly is adapted to actively cool the area sufficiently so as to substantially prevent neo-intimal hyperplasia in the area.

63. A system for treating a condition associated with an AV-fistula graft implanted within a patient and extending between first and second anastomoses between the AV-fistula graft and first and second blood vessels, respectively, wherein the system includes a treatment assembly that is positionable at a location within a lumen of the AV-fistula graft and is actuatable so as to couple energy between the treatment assembly and an area corresponding to the AV-fistula graft and adjacent to the treatment assembly that is sufficient to cause a therapeutic affect to the patient, and wherein:

the system further comprises a hemodialysis needle;

the treatment assembly comprises an adjustable member that is adjustable between a first configuration with a first outer diameter and a second configuration with a second larger outer diameter;

the treatment assembly with the adjustable member in the first configuration is deliverable into the lumen of the fistula and to the location through the hemodialysis needle; and

the adjustable member is adjustable to the second configuration with the second larger outer diameter in the lumen of the fistula.

64. The system of claim 63, wherein the treatment assembly is adapted to actively cool the area.

65. The system of claim 64, wherein the treatment assembly is adapted to actively cool the area sufficient to substantially prevent neointimal hyperplasia in the area.

66. The system of claim 63, wherein the adjustable member comprises an inflatable balloon.