HEMODIALYSIS ACCESS WITH ON-OFF FUNCTIONALITY

• US 20060224100A1
• Filed: 06/19/2006
• Published: 10/05/2006
• Est. Priority Date: 06/20/2001
• Status: Active Grant

• Current Assignee: Michael Gertner
• Original Assignee: Michael Gertner
• Inventors: Gertner, Michael
• Granted Patent: US 7,762,980 B2
• Time in Patent Office: Days
• US Class Current: 604/7
• 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 graft, comprising:

a tubular graft body having a tubular wall extending between two opposite end portions and a lumen within the tubular wall extending along a longitudinal axis between the two opposite end portions; and

a valve system coupled to the lumen and that is adjustable between an open condition and a closed condition with respect to the lumen;

wherein in the open condition the tubular graft body is substantially adapted to allow substantial fluid communication through the tubular graft body; and

wherein in the closed condition the fluid communication through the tubular graft body is substantially occluded.

2. The graft of claim 1, wherein the valve system comprises:

at least one valve with an expandable member coupled to the AV-fistula lumen and that is adjustable between a radially collapsed condition and a radially expanded condition;

wherein the radially collapsed condition characterizes at least in part the open condition for the valve system and allows for fluid communication between anastomoses associated with the two opposite end portions; and

wherein the radially expanded condition characterizes at least in part the closed condition for the valve system and substantially occludes the fistula lumen.

3. The graft of claim 2, wherein the expandable member comprises an inflatable balloon.

4. The graft of claim 3, wherein the valve system further comprises:

an inflation chamber that is adapted to allow the inflatable balloon to be inflated with pressurized fluid from a needle positioned within the inflation chamber.

5. The graft of claim 4, wherein the inflation chamber is positioned to allow the needle to inflate the balloon during advancement or withdrawal of the needle either before or after performing a hemodialysis procedure with the needle.

6. The graft of claim 2, wherein the valve is located along one of the two opposite end portions of the AV-graft fistula.

7. The graft of claim 2, wherein the valve is located along an intermediate region of the fistula graft between the two end portions.

8. The graft of claim 2, further comprising:

two said valves positioned along two opposite ends, respectively, of the AV-fistula graft.

9. The graft of claim 8, wherein the two valves are adapted to be independently adjusted between the respective open and closed conditions.

10. The graft of claim 8, wherein the two valves are adapted to be adjusted together with a common actuator.

11. A hemodialysis method, comprising:

providing a bladder reservoir that is adapted to couple to an AV-fistula graft;

coupling the bladder reservoir to the AV-fistula graft;

implanting the AV-fistula graft within a body of a patient and extending between a first and a second anastomosis with a vein and an artery of the patient, respectively;

filling the bladder reservoir with a fluid agent; and

eluting the fluid agent from the bladder reservoir and into an area adjacent to the AV-fistula graft within the patient'"'"'s body.

12. The method of claim 11, further comprising:

eluting the fluid agent to a substantially circumferential area circumscribing a lumen of the AV-fistula graft.

13. The method of claim 11, further comprising:

substantially inhibiting formation of a stenosis associated with an AV-fistula implant along the location with the fluid eluting from the bladder reservoir.

14. The method of claim 11, further comprising:

removing at least a portion of a stenosis associated with the AV-fistula implant with the fluid agent eluting from the bladder reservoir.

15. The method of claim 11, further comprising:

at least in part preventing neo-intimal hyperplasia in the area with the fluid agent eluting from the bladder reservoir.

16. The method of claim 11, further comprising inhibiting at least one of thrombogenesis or thrombus adhesion in the area with the fluid eluting from the bladder reservoir.

17. The method of claim 11, further comprising:

securing the bladder reservoir to a tubular graft body of the AV-fistula graft;

fluidly coupling a second reservoir to the bladder reservoir and secured to the bladder reservoir;

storing a volume of the fluid agent within the second reservoir;

delivering the volume of the fluid agent from the second reservoir to the bladder reservoir; and

allowing the volume of fluid agent to elude from the bladder reservoir and into the area.

18. The method of claim 17, further comprising:

refilling the second reservoir with a second volume of the fluid agent.

19. A hemodialysis method, comprising:

adjusting an AV-fistula graft, implanted within a patient and extending between an arterial and a venous anastomosis, between an open condition and a closed condition;

wherein in the open condition, the AV-fistula graft substantially allows fluid communication between the arterial anastomosis and the venous anastomosis; and

wherein in the closed condition the AV-fistula graft substantially prevents fluid communication between the arterial anastamosis and the venous anastomosis.

20. The method of claim 19 further comprising:

filling a balloon within the A-V fistula graft to prevent flow through the AV-fistula graft.

21. The method of claim 19 further comprising:

removing blood from the A-V fistula graft after the A-V fistula graft is adjusted to the closed condition and placing a fluid inside the A-V fistula graft when the AV-fistula graft is in the closed condition.

22. The method of claim 19 wherein an actuator is actuated to adjust the A-V fistula graft from the open condition to the closed condition.