Dialysis valve and method

• US 10,046,103 B2
• Filed: 02/17/2016
• Issued: 08/14/2018
• 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:
  US15/046,070
• Publication Number:
  US 20160158432A1
• Time in Patent Office: 909 Days
• 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 apparatus sized to fit in a body limb;

a flexible implantable tube portion coupled to the implantable valve actuation apparatus and configured to convey blood, the flexible implantable tube portion comprising a flexible polymer material and a nitinol structure;

a blood input graft portion in fluid communication with the flexible implantable tube portion and being configured to attach with a blood vessel for receiving blood;

a blood output graft portion in fluid communication with the flexible implantable tube portion and being configured to attach with another blood vessel for outputting blood; and

the implantable valve actuation apparatus 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 apparatus comprises a housing structure.

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

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

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 nitinol structure of 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 structure.

8. The device of claim 1, wherein the flexible polymer material of the flexible implantable tube portion defines a substantially smooth inner surface that conceals the nitinol structure.

9. 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.

10. 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.

11. The device of claim 10, 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.

12. 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.

13. 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.

14. The device of claim 1, wherein the implantable valve actuation apparatus comprises a housing structure, and the hydraulic port and the controllable valve actuation member are housed together in the housing structure.

15. An implantable dialysis valve device, comprising:

a flexible implantable tube that extends a longitudinal length, has a substantially smooth inner surface, and is operable to receive blood from a first blood vessel and output the blood to second blood vessel when implanted, the flexible implantable tube comprising a nitinol structure;

a blood input graft portion in fluid communication with the flexible implantable tube portion and being configured to attach with a blood vessel for receiving blood;

a blood output graft portion in fluid communication with the flexible implantable tube portion and being configured to attach with another blood vessel for outputting blood; and

an implantable valve actuation apparatus sized to fit in a body limb proximate to the first and second blood vessels that is coupled to the flexible implantable tube, further comprising;

a self-sealing membrane configured to be repeatedly punctured by an infusion needle when the self-sealing membrane is implanted adjacent to an underside of a skin region, and

a controllable valve actuation member in fluid communication with the self-sealing membrane, wherein the flexible implantable tube extends through the controllable valve actuation member, and the controllable valve actuation member is configured to, in response to pressurized injection of a hydraulic fluid through the self-sealing membrane and into the controllable valve actuation member, alter the flexible implantable tube from an open configuration in which blood flows into the flexible implantable tube for a dialysis treatment to a second configuration.

16. The device of claim 15, wherein the implantable valve actuation apparatus comprises a housing structure, wherein the flexible implantable tube portion extends through the housing structure of the implantable valve actuation apparatus.

17. The device of claim 15, 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 from the second configuration to the open configuration, wherein the flexible implantable tube in the second configuration is closed to prevent blood flow through the flexible implantable tube.

18. The device of claim 15, wherein the implantable valve actuation apparatus comprises a housing structure to which the self-sealing membrane is directly mounted, and the controllable valve actuation member is housed within the housing structure.

19. The device of claim 15, 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 from the second configuration to the open configuration, wherein the flexible implantable tube in the second configuration has a decreased diameter at a narrowed portion while not fully closing the flexible implantable tube.

20. The device of claim 19, wherein the flexible implantable tube, 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 of less than about 300 cc per minute when the flexible implantable tube receives blood from the first blood vessel.