Methods for regulating the flow of blood through the blood system

• US 20040015230A1
• Filed: 07/15/2003
• Published: 01/22/2004
• Est. Priority Date: 12/18/1996
• Status: Active Grant

• Current Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Original Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Inventors: Moll, Franciscus Laurens, Kalmann, Menno
• Granted Patent: US 6,979,350 B2
• Time in Patent Office: Days
• 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. A minimally-invasive method of implanting a valve prosthesis device within an existing vein of a human to restore venous valvular function within the vein, the valve prosthesis device adapted to press outward against the inner walls of the vein to hold the valve prosthesis device in position within the vein following implantation, the method comprising the steps of:

positioning the valve prosthesis device within a hollow distal portion of an introducer with the valve prosthesis device in a compressed state;

advancing the hollow distal portion of the introducer, with the valve prosthesis device positioned therein, into the vein of the human through an opening in a wall of the vein; and

expelling the valve prosthesis device from the distal portion into the vein to cause the device to expand to an operational state in which the valve prosthesis device is maintained in position within the vein by pressing outward against the inner walls of the vein.

2. The method of claim 1, wherein the step of expelling comprises slidably advancing an expulsion member distally to forcibly displace the valve prosthesis device from the distal portion of the introducer.

3. The method of claim 1, wherein the valve prosthesis device comprises a generally flat, resilient frame which is rollable upon itself to place the frame in a tubular configuration, and wherein the step of positioning comprises rolling the frame against a biasing force to place the valve prosthesis device in a radially-compressed configuration that corresponds to an inner diameter of the hollow distal portion of the introducer.

4. A method for regulating the flow of blood in a blood vessel through an implantable venous valve prosthesis device having a proximal end and a distal end, the method comprising:

directing a pulse of blood through the distal end of the prosthesis device and out the proximal end;

opening a temporary blood storage area having inner and outer walls within the prosthesis device to prevent the pulse of blood from flowing back through the distal end of the device; and

storing any back-flowing blood within the temporary blood storage area between the inner and outer walls.

5. The method of claim 4, further comprising closing the temporary blood storage area and forcing the blood stored therein out of the storage area and out of the proximal end of the device upon the passage of a subsequent pulse of blood through the distal end of the prosthesis device and out the proximal end.

6. The method of claim 4, wherein the temporary blood storage area comprises at least one pocket having an opening adjacent the proximal end of the device.

7. The method of claim 6, wherein the temporary blood storage area comprises three pockets arranged substantially circumferentially within the device.

8. The method of claim 7, wherein directing the pulse of blood through the device comprises directing the pulse of blood between the pockets.