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US 10,864,094 B2Granted
Fatigue-resistant flow regulating device and manufacturing methods
AssigneeDeep Vein Medical, Inc.
InventorsPeter W. J. Hinchliffe, Menno Kalmann, Adam I. Lehman, Olga Laksin
Life of this patent
Estimating the term…
Abstract
The subject invention is directed to devices and methods for producing devices for regulating blood flow in the venous system. In particular, the invention provides for artificial valves designed to regulate the flow of blood in human vessels, wherein such artificial valves include superior properties including fatigue resistance, biocompatibility, and ease of manufacture.
Claims7
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;
- 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;
- and
- f) spraying the support with silicone lubricant, to prevent adherence of the valve membrane to the support during the joining step.
4 more elements
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 using a pre-shaped bi-axially stress relieved and annealed ePTFE material with the porosity range selected between 15 and 25 microns and 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, wherein the valve member comprises
- 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;
- 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.
2 more elements
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, 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;
- 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;
- 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.
2 more elements
Dependencies are inferred from the claim text.