Device for regulating the flow of blood through the blood system

• US 6,287,334 B1
• Filed: 12/17/1997
• Issued: 09/11/2001
• Est. Priority Date: 12/18/1996
• Status: Expired due to Term

• Current Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Original Assignee: VenPro Corporation (Medtronic Plc)
• Inventors: Moll, Franciscus Laurens, Kalmann, Menno
• Primary Examiner(s): Nguyen, Dinh X.
• Application Number:
  US08/992,350
• Time in Patent Office: 1,364 Days
• Field of Search: 623/2, 623/1, 623/11, 623/66, 623/12, 623/900, 623/1.1, 623/1.11, 623/1.24, 623/1.26, 623/2.1, 623/23.64, 623/23.68, 623/23.7, 128/898, 251/358
• 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 venous valve prosthesis device for regulating the flow of blood in a blood vessel of a patient, the device comprising:

a support frame which is configured to be positioned within a vein, wherein the support frame is configured to press outward against inner walls of the vein to hold the prosthesis device in place following implantation; and

at least one collapsible flow restriction pocket attached to the support frame, the flow restriction pocket comprising an inner wall and an outer wall, the inner wall being displaceable by the flow of blood through the vein such that the collapsible flow restriction pocket assumes a collapsed configuration wherein the inner wall is forced against the outer wall when blood flows through the vein in a forward direction, and assumes an open configuration wherein the inner wall is forced away from the outer wall when blood flows through the vein in a reverse direction;

wherein the flow restriction pocket impedes the flow of blood in the reverse direction when the flow restriction pocket is in the open configuration.

2. The valve prosthesis device as in claim 1, wherein the collapsible flow restriction pocket is configured to open and close within a vein of a human in response to blood flow at venous-level pressures.

3. The valve prosthesis device as in claim 1, wherein the collapsible flow restriction pocket has a generally conical shape when the flow restriction pocket is in the open configuration.

4. The valve prosthesis device as in claim 1, wherein the collapsible flow restriction pocket assumes a substantially flat, arcuate configuration which conforms to an inner surface of the vein when the flow restriction pocket is in the collapsed configuration.

5. The valve prosthesis device as in 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 vein during an implantation procedure, and wherein the frame automatically expands radially when the prosthesis device is deployed within the vein.

6. The valve prosthesis device as in claim 5, wherein the support frame comprises a generally flat wire frame which is rolled upon itself to assume the generally tubular configuration.

7. The valve prosthesis device as in claim 6, wherein the support frame comprises a resilient wire and is biased toward an unrolled configuration.

8. The valve prosthesis device as in claim 6, wherein the wire frame comprises a memory metal, and is preprogrammed to assume an expanded configuration within the vein at a predetermined temperature.

9. The valve prosthesis device as in claim 5, in combination with an introducer for implanting the valve prosthesis device within the vein using a minimally-invasive implantation procedure, the introducer comprising a hollow distal portion which is configured to receive the valve prosthesis device in a compressed form, the tubular distal portion configured to be advanced into the vein through an opening in the vein to position the valve prosthesis device within the vein.

10. The valve prosthesis device as in claim 9, wherein the introducer comprises an elongated sliding member which is advanceable by a physician to forcibly displace the valve prosthesis device from the hollow distal portion into the vein.

11. The valve prosthesis device as in claim 1, wherein a plurality of the collapsible flow restriction pockets are attached to the support frame.

12. A venous valve prosthesis which is adapted to restore venous valvular function within the vein of a human, the prosthesis comprising:

a generally tubular support member configured to be inserted within a vein, wherein the support member comprises a wire frame which is rolled upon itself to form the generally tubular configuration; and

at least one flow stoppage member attached to the support member and defining a temporary blood storage area within the support member, the temporary blood storage area having inner and outer walls adapted to open and close in response to changes in a direction of blood flow through the vein.

13. The venous valve prosthesis as in claim 12, wherein the wire frame comprises a memory metal.

14. A venous valve prosthesis system which is adapted to restore venous valvular function within the vein of a human, the prosthesis comprising:

a generally tubular support member configured to be inserted within a vein;

at least one flow stoppage member attached to the support member and defining a temporary blood storage area within the support member, the temporary blood storage area having inner and outer walls adapted to open and close in response to changes in a direction of blood flow through the vein; and

an introducer for implanting the prosthesis within the vein using a minimally-invasive implantation procedure, the introducer comprising a hollow distal portion which is configured to receive the valve prosthesis in the radially-compressed state, the tubular distal portion configured to be advanced through an opening in the vein to position the prosthesis within the vein.

15. The venous valve prosthesis system as in claim 14, wherein the introducer comprises an elongated sliding member which is advanceable by a physician to forcibly displace the prosthesis from the hollow distal portion into the vein.