FATIGUE-RESISTANT FLOW REGULATING DEVICE AND MANUFACTURING METHODS

• US 20130123908A1
• Filed: 03/09/2011
• Published: 05/16/2013
• Est. Priority Date: 03/17/2010
• Status: Active Grant

• Current Assignee: Deep Vein Medical, Inc.
• Original Assignee: Deep Vein Medical, Inc.
• Inventors: Hinchliffe, Peter W.J., Kalmann, Menno, Lehman, Adam I., Laksin, Olga
• Granted Patent: US 9,801,737 B2
• Time in Patent Office: Days
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 27/047 Other specific metals or alloys not covered by A61L27/042 - A61L27/045 or A61L27/06
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: Y10T 156/1051 by folding

Abstract

The artificial valves and methods described herein and shown in the drawings, provide for artificial valves with superior properties including fatigue resistance, biocompatibility, and ease of manufacture.

Claims

1. An implantable device for regulating blood flow through a blood vessel, comprising:

a) an elongated support dimensioned and configured to be implanted in a blood vessel, the support including axially spaced apart first and second substantially annular support portions, and a linking member linking the axially spaced apart portions to one another; and

b) a valve membrane extending between the axially spaced apart support portions, the valve membrane including a first region, a second region, and a flap adjacent the first region, the flap folded over the linking member for attachment to the first region for attachment of the valve membrane to the linking member and the second region being adjacent the first region and unattached to the linking member, the second region movable between a first position to enable blood flow and a second position to inhibit blood flow, wherein at least one of the flap and the first region includes an impregnation material therein, and wherein the flap is joined to the first region of the valve membrane at a substantially seamless, heat shaped adhesion region that includes the impregnation material.

2. An implantable device as recited in claim 1, wherein the linking member includes two curved members intersecting one another to form an x-shape.

3. An implantable device as recited in claim 1, wherein the support is formed at least in part from a one piece Nitinol construct.

4. An implantable device as recited in claim 1, wherein the valve membrane is formed at least in part from ePTFE.

5. An implantable device as recited in claim 1, wherein the impregnation material includes a biocompatible polycarbonate polyurethane material.

6. A method of making an implantable device for regulating blood flow through a blood vessel, comprising:

a) forming an elongated support dimensioned and configured to be implanted in a blood vessel, the support including axially spaced apart first and second substantially annular support portions, and a linking member linking the axially spaced apart portions to one another;

b) forming a valve membrane configured for extending between the axially spaced apart support portions, the valve membrane including a first region, a second region, and a flap adjacent the first region, and the second region being adjacent the first region and configured to be unattached to the linking member and movable between a first position to enable blood flow and a second position to inhibit blood flow;

c) folding the flap over the linking member for attachment to the first region of the valve membrane for attachment of the valve membrane to the linking member;

d) impregnating at least one of the flap and the first region of the valve membrane with an impregnation material; and

e) joining the flap substantially seamlessly to the first region of the valve membrane by heat shaping at least one of the flap and the first region to form an adhesion region joining the flap and the first region together, wherein the adhesion region includes the impregnation material.

7. A method as recited in claim 6, wherein the linking member includes two curved members intersecting one another to form an x-shape.

8. A method as recited in claim 6, wherein the support is formed at least in part from a one piece Nitinol construct.

9. A method as recited in claim 6, wherein the valve membrane is formed at least in part from ePTFE.

10. A method as recited in claim 6, wherein the impregnation material includes a biocompatible polycarbonate polyurethane material.

11. A method as recited in claim 6, further comprising spraying the support with silicone lubricant, to prevent adherence of the valve membrane to the support during the joining step.

12. A method as recited in claim 6, wherein the folding and joining steps include wrapping the flap around the support and welding of the valve membrane material to itself at the flap and first region, and forming a continuous flexible seam around the support, without the valve membrane being adhered to the support.

13. A method as recited in claim 6, further comprising using a pre-shaped bi-axially stress relieved and annealed ePTFE material for the valve membrane with the porosity range selected between 15 and 25 microns.

14. A method as recited in claim 6, wherein the step of forming the valve membrane includes forming the valve membrane from a thermally-fitted and fully annealed polymer sheet for reducing the risk of folds and creases in the valve membrane that could otherwise harbor cellular adherence.

15. A method as recited in claim 6, wherein the step of joining includes melting the impregnation material to smooth out the adhesion region making the adhesion region substantially seamless, reducing potential for blood or cellular adherence thereto.

16. A method as recited in claim 6, wherein the step of forming the valve membrane includes using a pre-programmed laser cutting apparatus to cut out openings in the valve membrane for allowing blood flow though the implantable device.