Dialysis valve and method

• US 8,012,134 B2
• Filed: 09/08/2010
• Issued: 09/06/2011
• 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): Stigell; Theodore
• Assistant Examiner(s): Schmidt; Emily
• Application Number:
  US12/877,806
• Publication Number:
  US 20100331757A1
• Time in Patent Office: 363 Days
• Field of Search: 604/4.01, 604/6.1, 604/246, 604/250, 251/4, 251/5, 623 124- 144
• 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 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. An implantable dialysis valve for fluid connection between an artery and a vein, comprising:

an implantable housing sized to fit between an artery and a vein;

an arterial fistula graft connected with the housing to attach with the artery when the housing is implanted;

a venous fistula graft connected with the housing to attach with the vein when the housing is implanted;

a flexible tube movable relative to the implantable housing and extending through the implantable housing 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 having a substantially smooth coating;

a controllable spring member coupled to the tube to selectively adjust from a first length to a second length in response to electric control, the controllable spring member being coupled with the tube so that when the controllable spring member 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 dialysis valve of claim 1, wherein the tube decreases in diameter at the narrowed portion while not fully closing the tube.

3. The dialysis valve of claim 2, wherein the tube comprises a braided nitinol structure having an elastomeric coating.

4. The dialysis valve of claim 3, wherein the inner surface of the tube is coated with an anti-thrombogenic material.

5. The dialysis valve of claim 3, wherein the controllable spring member comprises a nitinol spring that adjusts from the first length to the second length in response to the electric control.

6. The dialysis valve of claim 2, wherein the tube decreases in diameter at the narrowed portion while not fully closing the tube to blood flow so that the tube operable to constrict and provide blood flow therethrough at an increased velocity to hinder the formation of thrombus or clotting.

7. The dialysis valve of claim 6, 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.

8. The dialysis valve of claim 1, wherein the controllable spring member comprises a shape memory spring structure attached to the tube such that, when the shape memory spring structure 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.

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

implanting a dialysis valve comprising a tube between a patient'"'"'s vein and an artery and a controllable spring member coupled to the tube, the tube operable to convey fluids and defining a longitudinal dimension, a diameter and an inner surface, wherein the tube is repeatably adjustable in longitudinal dimension and in diameter while the inner surface is configured to maintain fluid containing capability;

narrowing the diameter of the tube in an adjustable manner between dialysis treatments at a location along the longitudinal dimension of the tube, wherein the diameter of the tube is narrowed while not fully closing the diameter to thereby provide blood flow through the tube between dialysis treatments;

and opening the diameter of the tube at the narrowed location by shifting the controllable spring member from a first position to a second position to thereby adjust the longitudinal dimension of the tube to conduct a dialysis treatment, wherein the diameter of the tube is opened to provide increased blood flow through the tube during the dialysis treatment,

wherein the dialysis valve comprises;

an implantable housing enclosing the tube and the controllable spring member, an arterial fistula graft connected with the housing to attach with the artery when the housing is implanted, and a venous fistula graft connected with the housing to attach with the vein when the housing is implanted.

10. The method of claim 9, wherein the inner surface of the tube at the narrowed location is in a substantially circular configuration.

11. The method of claim 9, wherein the inner surface of the tube is substantially smooth and comprises an anti-thrombogenic coating.

12. The method of claim 9, wherein the diameter of the tube is narrowed to provide blood flow through the tube between dialysis treatments at a blood flow rate of less than about 300 cc per minute.

13. The method of claim 9, wherein the tube comprises a braided nitinol structure coated with an elastomer allowing the tube to be repeatedly altered in longitudinal dimension and in diameter and still maintain fluid containing capability.

14. The method of claim 9, wherein the controllable spring member comprises a shape memory spring structure attached to the tube such that, when the shape memory spring structure 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.

15. The method of claim 9, wherein the implantable housing is sized to fit proximate to the patient'"'"'s vein and artery inside the patient'"'"'s body.