Dialysis valve and method

• US 9,295,774 B2
• Filed: 01/13/2014
• Issued: 03/29/2016
• Est. Priority Date: 04/23/2003
• Status: Active Grant

• Current Assignee: Interrad Medical, Inc.
• Original Assignee: Interrad Medical, Inc.
• Inventors: Claude, Timothy J., Barlow, Edward A., Hunter, David W., Rosenberg, Michael S.
• Primary Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US14/153,563
• Publication Number:
  US 20140128794A1
• Time in Patent Office: 806 Days
• US Class Current: 1/1
• 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 device, comprising:

an implantable valve actuation device sized to fit in a body limb;

a blood input tube portion connected with the implantable valve actuation device to attach with a blood vessel for receiving blood when the implantable valve actuation device is implanted;

a blood output tube portion connected with the implantable valve actuation device to attach with a blood vessel for outputting blood when the implantable valve actuation device is implanted;

a flexible implantable tube portion coupled to the implantable valve actuation device and configured to convey blood received from the blood input tube portion, the flexible implantable tube portion comprising a flexible polymer material; and

the implantable valve actuation device comprising;

a self-sealing membrane configured to be repeatedly punctured when the self-sealing membrane is implanted adjacent to an underside of a skin region, a hydraulic port proximate to the self-sealing membrane such that the self-sealing membrane is positioned between the hydraulic port and the skin region when the self-sealing membrane is implanted adjacent to the underside of the skin region, a controllable valve actuation member in fluid communication with the hydraulic port, wherein the controllable valve actuation member is movable, in response to pressurized injection of a hydraulic fluid through the self-sealing membrane and the hydraulic port to act upon the controllable valve actuation member, to alter the flexible implantable tube portion from an open configuration in which blood flows into the flexible implantable tube portion for a dialysis treatment to a second configuration,

wherein the flexible implantable tube portion extends through the controllable valve actuation member.

2. The device of claim 1, wherein the implantable valve actuation device comprises a housing structure.

3. The device of claim 2, wherein the flexible implantable tube portion extends through the housing structure component of the implantable valve actuation device.

4. The device of claim 3, wherein the controllable valve actuation member is positioned in the housing structure component of the implantable valve actuation device.

5. The device of claim 1, wherein the flexible implantable tube portion is movable relative to the self-sealing membrane and the hydraulic port.

6. The device of claim 1, wherein the flexible implantable tube portion comprises a braided structure.

7. The device of claim 6, wherein the flexible polymer material includes an elastomeric coating along the braided nitinol structure.

8. The device of claim 1, wherein the flexible implantable tube portion comprises a nitinol structure.

9. The device of claim 1, wherein the flexible polymer material of the flexible implantable tube portion defines a substantially smooth inner surface, the inner surface of the flexible implantable tube portion being coated with an anti-thrombogenic material.

10. The device of claim 1, wherein the controllable valve actuation member comprises an adjustable structure selected from the group consisting of:

an adjustable bellows structure, and an inflatable balloon structure.

11. The device of claim 1, wherein the controllable valve actuation member is movable, in response to withdrawal of the hydraulic fluid through the self-sealing membrane, to alter the flexible implantable tube portion from the second configuration to the open configuration, wherein the flexible implantable tube portion in the second configuration has a decreased diameter at a narrowed portion while not fully closing the flexible implantable tube portion.

12. The device of claim 11, wherein the flexible implantable tube portion, when in the second configuration, has the decreased diameter at a narrowest portion while not fully closing to provide a blood flow rate through the flexible implantable tube portion of less than about 300 cc per minute when the flexible implantable tube portion receives blood from the blood input tube portion.

13. The device of claim 1, further comprising an infusion needle configured to penetrate through the skin region and the self-sealing membrane to provide the pressurized injection of the hydraulic fluid.

14. The device of claim 1, wherein the controllable valve actuation member is movable, in response to withdrawal of the hydraulic fluid through the self-sealing membrane, to shift the flexible implantable tube portion from the second configuration to the open configuration, wherein the flexible implantable tube portion in the second configuration is closed to prevent blood flow through the flexible implantable tube portion.

15. A method of controlling blood flow for dialysis treatments, comprising:

implanting an implantable dialysis valve device in a body limb proximate to a vein, wherein said implanting comprises;

inserting a self-sealing membrane of an implantable valve actuation device of the implantable dialysis valve adjacent to an underside of a skin region such that the self-sealing membrane is configured to be repeatedly punctured, the self-sealing membrane being positioned between a hydraulic port of the implantable valve actuation device and the skin region;

attaching a blood input tube portion connected with the implantable valve actuation device to a blood vessel for receiving blood into the blood input tube portion, the blood input tube portion being in fluid communication with a flexible implantable tube portion of the implantable dialysis valve so that the flexible implantable tube portion is configured to convey blood received by the blood input tube portion, the flexible implantable tube portion comprising a flexible polymer material; and

attaching a blood output tube portion connected with the implantable valve actuation device to another blood vessel for outputting blood into an internal blood stream after a dialysis treatment; and

after implanting the implantable dialysis valve device in the body limb, penetrating the self-sealing membrane of the implantable valve actuation device to deliver a pressurized injection of a hydraulic fluid through the self-sealing membrane and the hydraulic port of the implantable valve actuation device;

in response to the pressurized injection of the hydraulic fluid through the self-sealing membrane and the hydraulic port of the implantable valve actuation device, adjusting a controllable valve actuation member to alter the flexible implantable tube portion from an open configuration in which blood flows into the flexible implantable tube portion for a dialysis treatment to a second configuration,

wherein the flexible implantable tube portion extends through the controllable valve actuation member.

16. The method of claim 15, further comprising withdrawing the hydraulic fluid from the hydraulic port using an instrument that is penetrated through the self-sealing membrane.

17. The method of claim 16, further comprising, in response to said withdrawing of the hydraulic fluid from the hydraulic port, adjusting the controllable valve actuation member so as to alter the flexible implantable tube portion from the second configuration to the open configuration, wherein the flexible implantable tube portion in the second configuration has a decreased diameter at a narrowed portion while not fully closing the flexible implantable tube portion.

18. The method of claim 15, wherein the hydraulic fluid comprises saline.

19. The method of claim 15, wherein the implantable valve actuation device comprises a housing structure that is implantable in the body limb.

20. The method of claim 19, wherein the flexible implantable tube portion extends through the housing structure component of the implantable valve actuation device, and the controllable valve actuation member is positioned in the housing structure component of the implantable valve actuation device.

21. The method of claim 16, further comprising:

withdrawing the hydraulic fluid from the hydraulic port using an instrument that is penetrated through the self-sealing membrane; and

adjusting the controllable valve actuation member so as to alter the flexible implantable tube portion from the second configuration to the open configuration, wherein the flexible implantable tube portion in the second configuration is closed to prevent blood flow through the flexible implantable tube portion.

22. The method of claim 15, wherein the flexible implantable tube portion comprises a braided structure.