Dialysis valve and method

• US 7,811,264 B2
• Filed: 04/28/2009
• Issued: 10/12/2010
• Est. Priority Date: 04/23/2003
• Status: Active Grant

• Current Assignee: Interrad Medical, Inc.
• Original Assignee: Interrad Medical, Inc.
• Inventors: Rosenberg, Michael S., Claude, Timothy J., Hunter, David W., Barlow, Edward A.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US12/431,101
• Publication Number:
  US 20090209921A1
• Time in Patent Office: 532 Days
• Field of Search: 604/4.01, 604/6.1, 604/246, 604/250, 623/1.24, 623/1.36, 623/1.44, 606/158, 251/4, 251/5, 251/7, 251/8, 251/129.06
• US Class Current: 604/246
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61M 39/228 with a tubular diaphragm constrictable by radial fluid force

Abstract

A dialysis valve includes a tube attached between an artery and a vein which, when elongated, simultaneously narrows in diameter at least one location. The narrowed portion of the tube decreases the volume and velocity between the arterial and venous side of the patient to prevent damage or intimal hyperplasia on the venous side between dialysis treatments. When the valve is opened for dialysis, an unrestricted blood flow exists between the arterial and venous side, permitting a controlled, open blood flow during dialysis.

Claims

1. A method of controlling blood flow between and during dialysis treatments, comprising:

implanting a dialysis valve device in a bodily limb between an artery and a vein;

attaching an arterial fistula graft of the dialysis valve device to the artery in the bodily limb;

attaching a venous fistula graft of the dialysis valve device to the vein in the bodily limb;

causing an adjustable tube of the dialysis valve device to convey blood from the arterial fistula graft to the venous fistula graft, the tube extending for a longitudinal length and defining an inner surface that is substantially smooth;

controlling an actuator of the dialysis valve device to selectively adjust from a first length to a second length in response to fluid or electric control, the actuator being coupled with the tube so that when the actuator adjusts from the first length to the second length, the tube contemporaneously increases in longitudinal length and decreases in diameter at a narrowed portion.

2. The method of claim 1, the step of controlling the actuator causes the tube to decrease in diameter at the narrowed portion while not fully closing the tube to blood flow so that the tube constricts and provides blood flow therethrough at an increased velocity to hinder the formation of thrombus or clotting.

3. The method of claim 2, wherein the tube decreases in diameter at a narrowest portion while not fully closing to provide a blood flow rate through the tube of less than about 300 cc per minute when the tube is implanted between an artery and a vein.

4. The method of claim 2, further comprising controlling the actuator of the dialysis valve device to selectively adjust from the second length to the first length so that the tube contemporaneously decreases in longitudinal length and increases in diameter at a narrowed portion.

5. The method of claim 1, wherein the adjustable tube of the dialysis valve device comprises a braided nitinol structure having a flexible coating such that the inner surface of the tube is substantially smooth and coated with an anti-thrombogenic material.

6. The method of claim 1, wherein the step of implanting the dialysis valve device in the bodily limb comprises implanting the dialysis valve device in an arm.

7. The method of claim 1, wherein the step of controlling the actuator of the dialysis valve device comprises adjusting a fluid controlled bellows from the first length to the second length, the bellows being in fluid communication with an actuation port that receives fluid through a self-sealing membrane for adjustment of the longitudinal length of the tube.

8. The method of claim 7, wherein when the fluid is urged into an inner space defined by the bellows, the bellows increases in length and thereby actuates the tube to contemporaneously increase in longitudinal length and decrease in diameter at the narrowed portion.

9. The method of claim 7, wherein the step of implanting the dialysis valve device in the bodily limb comprises arranging the self-sealing adjacent to skin of the bodily limb.

10. The method of claim 1, wherein the step of controlling the actuator of the dialysis valve device comprises adjusting an inflatable balloon to a selected degree of inflation, the balloon acting upon the tube so that, when the balloon is inflated, the tube contemporaneously increases in longitudinal length and decreases in diameter at the narrowed portion.

11. The method of claim 1, rein the step of controlling the actuator of the dialysis valve device comprises adjusting a shape-memory spring attached to the tube such that, when the spring is controlled to shift from the first length to the second length, the tube contemporaneously increases in longitudinal length and decreases in diameter at the narrowed portion.

12. The method of claim 1, wherein the inner surface of the adjustable tube comprises an anti-thrombogenic coating or a pro-endothelialization coating.

13. The method of claim 1, wherein the adjustable tube of the dialysis valve device comprises an flexible material selected from the group of urethane, ePTFE (expanded Polytetrafluoroethylene), and silicone.

14. The method of claim 1, wherein the adjustable tube of the dialysis valve device comprises a first end that is attached to a floating connector in a housing of the dialysis valve device proximate to one of the arterial fistula graft and the venous fistula graft.

15. The method of claim 14, wherein the adjustable tube of the dialysis valve device comprises a second end that is attached to a fixed connector in the housing dialysis valve device proximate to the other of the arterial fistula graft and the venous fistula graft.