Device for regulating the flow of blood through the blood system

• US 6,605,112 B1
• Filed: 08/01/2000
• Issued: 08/12/2003
• Est. Priority Date: 12/18/1996
• Status: Expired due to Fees

• Current Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Original Assignee: VenPro Corporation (Medtronic Plc)
• Inventors: Moll, Franciscus Laurens, Kalmann, Menno
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): Blanco, Javier G.
• Application Number:
  US09/630,403
• Time in Patent Office: 1,106 Days
• Field of Search: 623/1.24, 623/1.26, 623/2-2-, 623/900
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

A valve prosthesis is disclosed which is implantable within a vein or other blood vessel of a patient using a minimally-invasive surgical procedure. The prosthesis includes a tubular wire frame which presses radially outward against the inner walls of the blood vessel following implantation to hold the prosthesis in position. Multiple flow-resistive pockets that open and close in response to changes in blood flow direction are attached to the frame to impede the flow of blood in the reverse direction. The prosthesis is implanted using an introducer catheter which holds the prosthesis in a radially-compressed state as the prosthesis is inserted into and positioned within the blood vessel.

Claims

1. An implantable prosthesis device for regulating the flow of blood in a blood vessel of a patient, the device comprising:

a support frame made of a memory material configured to be positioned against an inner surface of the blood vessel, the support frame having a lumen extending between a proximal end and a distal end of the support frame, wherein the support frame is compressible to a first configuration adapted for delivery of the device into the blood vessel and is expandable to a second configuration adapted for implantation of said device within the blood vessel; and

at least one valve element attached to the support frame, the valve element comprising at least one wall within the lumen of the support frame that is displaceable by the flow of blood through the blood vessel such that when blood flows through the blood vessel in a forward direction, the at least one wall moves toward the inner surface of the blood vessel into a collapsed, generally flattened configuration, the at least one wall being moveable away from the inner surface of the blood vessel into an open configuration when blood flows through the blood vessel in a reverse direction;

wherein the wall in its open configuration forms at least in part a flow restriction pocket defined between the wall and the inner surface of the blood vessel.

2. The prosthesis device of claim 1, wherein the at least one wall when collapsed assumes a substantially flat, arcuate configuration which generally conforms to the inner surface of the blood vessel.

3. The prosthesis device of claim 1, wherein the support frame comprises at least one wire.

4. The prosthesis device of claim 3, wherein the support frame is made from a single wire.

5. The prosthesis device of claim 3, wherein the valve element is supported on a portion of the frame having at least three interconnected wire portions.

6. The prosthesis device of claim 5, wherein the valve element is supported on a substantially triangular frame section.

7. The prosthesis device of claim 1, wherein the support frame is made of a memory metal.

8. The prosthesis device of claim 1, wherein the support frame has a generally tubular configuration and is adapted to be compressed radially to a diameter which is less than an inner diameter of the blood vessel during an implantation procedure, and wherein the frame automatically expands radially when the prosthesis is deployed within the blood vessel.

9. The prosthesis device of claim 1, wherein the support frame is cylindrically shaped.

10. The prosthesis device of claim 1, wherein the at least one wall has a proximal end and a distal end that are attached to proximal and distal sections of the support frame, respectively.

11. The prosthesis device of claim 10, wherein the flow restriction pocket comprises a flareable proximal end attached to a proximal portion of the support frame and defining an opening in the proximal portion of the support frame, and terminates in a distal end attached to a distal portion of the support frame.

12. The prosthesis device of claim 11, wherein the at least one wall forms a generally cone-shaped flow restriction pocket.

13. The prosthesis device of claim 1, wherein the at least one wall within the lumen of the support frame is an inner wall, and further comprising an outer wall covering at least a portion of the support frame.

14. The prosthesis device of claim 13, wherein the outer wall is positioned adjacent the inner wall such that when blood flows through the blood vessel in a forward direction, the inner wall moves toward the outer wall into its collapsed configuration, the inner wall and outer wall forming the flow restriction pocket when the inner wall is in its open configuration.

15. The prosthesis device of claim 1, wherein the at least one wall is displaceable within a vein of a human in response to blood flow at venous-level pressures.

16. The prosthesis device of claim 1, comprising three walls within the lumen of the support frame, each of said walls being displaceable by the flow of blood through the blood vessel such that when blood flows through the blood vessel in a forward direction, each of the walls moves toward the inner surface of the blood vessel into a collapsed, generally flattened configuration, each wall being moveable away from the inner surface of the blood vessel into an open configuration when blood flows through the blood vessel in a reverse direction.

17. An implantable prosthesis device for regulating the flow of blood in a blood vessel of a patient, the device comprising:

a support frame made of a memory material configured to be positioned against an inner surface of the blood vessel, the support frame having a lumen extending between a proximal end and a distal end of the support frame, wherein the support frame is compressible to a first configuration adapted for delivery of the device into the blood vessel and is expandable to a second configuration adapted for implantation of said device within the blood vessel; and

at least one flow restriction pocket supported within the lumen, the pocket comprising at least one wall supported within the lumen in both a proximal portion and a distal portion of the support frame, the at least one wall having a proximal lip configured to define an opening of the pocket in the proximal portion of the support frame between the wall and the inner surface of the blood vessel, the at least one wall being displaceable by the flow of blood through the blood vessel such that the wall is moveable toward a collapsed configuration which generally decreases the size of the opening when blood flows through the blood vessel in a forward direction, and is moveable toward an open configuration which generally increases the size of the opening when blood flows through the blood vessel in a reverse direction.

18. The prosthesis device of claim 17, wherein the at least one wall in its collapsed configuration generally conforms to the shape of the inner surface of the blood vessel.

19. The prosthesis device of claim 17, wherein the at least one wall having a proximal lip is an inner wall, and further comprising an outer wall attached to an inner surface of the frame.

20. The prosthesis device of claim 19, wherein the outer wall is positioned adjacent the inner wall such that when blood flows through the blood vessel in a forward direction, the inner wall moves toward the outer wall into its collapsed configuration, and wherein the flow restriction pocket is defined between the inner wall and the outer wall.

21. The prosthesis device of claim 17, wherein the proximal lip of the at least one wall is attached at the proximal end of the support frame, and a distal end of the at least one wall is attached at the distal end of the support frame.

22. The prosthesis device of claim 17, wherein a distal end of the at least one terminates in a pointed end section.

23. The prosthesis device of claim 17, wherein the support frame is a wire frame.

24. The prosthesis device of claim 23, wherein the wire frame is made of a memory metal.

25. The prosthesis device of claim 23, wherein the wire frame is substantially cylindrically shaped.

26. The prosthesis device of claim 17, comprising a plurality of walls supported within the lumen in both a proximal portion and a distal portion of the support frame, each wall having a proximal lip defining an opening of the pocket in the proximal portion of the support frame between the wall and the inner surface of the blood vessel, each wall being displaceable by the flow of blood through the blood vessel such that the wall is moveable toward a collapsed configuration which generally decreases the size of the opening when blood flows through the blood vessel in a forward direction, and is moveable toward an open configuration which generally increases the size of the opening when blood flows through the blood vessel in a reverse direction.