Device for regulating blood

• US 9,155,618 B2
• Filed: 01/06/2012
• Issued: 10/13/2015
• Est. Priority Date: 05/25/2006
• Status: Active Grant

• Current Assignee: Deep Vein Medical, Inc.
• Original Assignee: Deep Vein Medical, Inc.
• Inventors: Kalmann, Menno, Hinchliffe, Peter W. J., Lehman, Adam I.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US13/344,928
• Publication Number:
  US 20120101568A1
• Time in Patent Office: 1,376 Days
• Field of Search: 623 21- 219, 623/1.24
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

An implantable device for regulating blood flow through a blood vessel comprising an elongated support dimensioned and configured to be implanted in a blood vessel. The support includes a linking member linking axially spaced apart portions to one another. A valve membrane extends between the axially spaced apart support portions and includes first region folded over the first linking member and attached thereto and a second region adjacent the first region and unattached to the first linking member. The second region is movable between a first position to enable blood flow and a second position to inhibit blood flow.

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 ring portions and a first linking member, the annular ring portions circumscribing a longitudinal axis of the elongated support, the first linking member coupled to the first annular ring portion at a first end and coupled to the second annular ring portion at a second end, the first and second ends are substantially opposing each other such that the first linking member traverses the longitudinal axis of the elongated support; and

b) a valve membrane extending between the axially spaced-apart annular ring portions and having an upper portion, a lower portion and an intermediate portion, the valve membrane including a first region and a second lower region, the first region folded over the first linking member for attachment and the second region being adjacent the first region and unattached to the first linking member, the second region movable between a first position to enable blood flow and a second position to inhibit blood flow.

2. The device of claim 1, further comprising a third region folded over for attachment to the first linking member, the second region positioned between the first and third region.

3. The implantable device as recited in claim 1, wherein the first linking member is curved.

4. The implantable device as recited in claim 1, wherein the support is formed at least in part from a shape memory alloy material.

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

6. The implantable device as recited in claim 1, wherein the valve membrane is coated at least in part with an anti-clotting agent.

7. The implantable device as recited in claim 1, further comprising a second linking member, the valve membrane having a fourth region folded over the second linking member for attachment.

8. The implantable device as recited in claim 1, wherein the upper portion of the valve membrane is attached to a bottom region of the first annular ring portion and the lower portion of the membrane is attached to a top region of the second annular ring portion.

9. The implantable device of claim 8, wherein a section of the lower portion of the membrane is wrapped around a section of the top region of the second annular ring portion.

10. The implantable device as recited in claim 1, wherein the support is integrally formed from a laser cut tube.

11. 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 ring members and a first linking member, the ring members circumscribing a longitudinal axis of the elongated support, the first linking member coupled to the first ring member at a first end and coupled to the second ring member at a second end, the first and second ends are substantially opposing each other such that the first linking member traverses the longitudinal axis of the elongated support; and

b) a valve membrane supported by the support and including first, second and third portions, the first portion attached at a first region of the support, the third portion attached at a second region of the support, and the second portion positioned between the first and third portions and unattached to the support, the second portion movable with respect to the support between a first position to enable blood flow and a second position closer to the support to inhibit blood flow.

12. The implantable device of claim 11, wherein the first and third portions of the valve membrane form a flap wrapped around a portion of the support, and the second portion forms a flap movable with respect to the first and third portions to create an opening for antegrade blood flow.

13. The implantable device of claim 12, wherein the second portion of the valve membrane is closer to a top region than a bottom region of the valve membrane.

14. The implantable device of claim 11, wherein the valve membrane further comprises a fourth portion separate from the second portion and unattached to the support, the fourth portion movable with respect to the support between a first position to enable blood flow and a second position to inhibit blood flow.

15. The implantable device of claim 14, wherein the support includes a second linking traversing the longitudinal axis of the elongated support, wherein the second portion of the membrane forms a first flap adjacent the first linking member and the fourth portion forms a second flap adjacent the second linking member, the flaps each creating a space between the flap and the respective linking member during antegrade blood flow to enable blood flow through the space and the flap closing the space during retrograde blood flow.

16. The 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 and engagable with a blood vessel wall, the support including axially spaced-apart first and second ring portions and a first linking member, the ring portions circumscribe a longitudinal axis of the elongated support, the first linking member coupled to the first ring portion at a first end and coupled to the second ring portion at a second end, the first and second ends are substantially opposing each other such that the first linking member traverses the longitudinal axis of the elongated support; and

b) a valve membrane attached to the first linking member, the valve membrane having an upper portion attached to a first section of the support and a lower portion attached to a second section of the support, the valve membrane having an enabling condition to enable blood flow when blood flows in one direction and an inhibiting condition to inhibit blood flow when blood flows in an opposite direction, the upper attached portion of the membrane and the lower attached portion of the membrane remaining substantially fixed in position in both the enabling condition and the inhibiting condition and the lower and upper attached portions remaining adjacent opposing regions of the vessel wall in both conditions.

17. The implantable device of claim 16, wherein the valve membrane includes an intermediate portion between the upper and lower attached portions, and further includes a first flap in the intermediate portion, the first flap unattached to the support and movable for creating the flow inhibiting and flow enabling conditions while the upper and lower attached portions remain substantially fixed in position.

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

an elongated support dimensioned and configured to be implanted in a blood vessel, the elongated support comprising axially spaced-apart first and second ring members that circumscribe a longitudinal axis of the elongated support; and

a valve membrane supported by the support and having a first condition to enable blood flow and a second condition to inhibit blood flow, the valve membrane positioned within the elongated support at a first angle extending from the first ring member at a first position to the second ring member at a second position, which opposes the first position, such that the valve membrane traverses the longitudinal axis of the elongated support, the valve membrane remaining substantially at the first angle in the first and second conditions.

19. The implantable device of claim 18, wherein the valve membrane has a first region unattached to the support, the first unattached region formed by at least one cut in the membrane, the first unattached region creating an opening adjacent the support during antegrade blood flow.

20. The implantable device of claim 19, wherein the first unattached region moves adjacent the support to close the opening during retrograde blood flow.

21. The implantable device of claim 18, wherein the valve membrane has a second region unattached to the support and spaced from the first region, the second unattached region formed by at least one cut in the membrane, the second unattached region creating an opening adjacent the support during antegrade blood flow, wherein the second unattached region moves adjacent the support to close the opening adjacent the support during retrograde blood flow.

22. The implantable device of claim 21, wherein the first and second openings create a cross sectional shape ranging from about 15% to about 30% of the diameter of the vessel.

23. The implantable device of claim 21, wherein the valve membrane has an upper region and a lower region, and the first unattached region is closer to the top region than the bottom region.

24. The implantable device of claim 23, wherein the second unattached region is closer to the top region than the bottom region.