Percutaneous aortic valve

• US 9,138,313 B2
• Filed: 04/18/2012
• Issued: 09/22/2015
• Est. Priority Date: 11/21/2000
• Status: Expired due to Term

• Current Assignee: REX Medical LP
• Original Assignee: REX Medical LP
• Inventors: McGuckin, James F. Jr., Hinchliffe, Peter W. J.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US13/449,618
• Publication Number:
  US 20120203333A1
• Time in Patent Office: 1,252 Days
• Field of Search: 623 21- 238
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 2/2421 with non-pivoting rigid closure members
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A method of minimally invasively replacing a cardiac valve of a patient including inserting a delivery catheter intraluminally, inserting a valve resecting instrument intraluminally through the delivery catheter to a position adjacent the cardiac valve of a patient, manipulating the valve resecting instrument to resect the cardiac valve, removing the resected valve through the delivery catheter, and providing a delivery instrument having a replacement valve contained therein. The delivery instrument is advanced into the delivery catheter and intraluminally so that a distal end portion of the instrument is adjacent an annulus of a patient, and a first portion of the valve is exposed from the delivery instrument to position it on a first side of the annulus, and thereafter a second portion of the valve is exposed to position it on a second side of the annulus.

Claims

1. A method of minimally invasively replacing a cardiac valve of a patient comprising:

inserting a delivery catheter intraluminally, the delivery catheter having a longitudinal axis;

inserting a valve resecting instrument intraluminally through the delivery catheter to a position adjacent the cardiac valve of a patient;

manipulating the valve resecting instrument from outside the body to resect the cardiac valve;

removing the resected valve through the delivery catheter;

providing a delivery instrument having a replacement valve contained therein in an elongated reduced profile insertion configuration extending along the longitudinal axis of the delivery catheter;

advancing the delivery instrument into the delivery catheter and intraluminally so that a distal end portion of the instrument is adjacent an annulus of a patient;

exposing a first portion of the valve from the delivery instrument to position it on a first side of the annulus, the first portion moving to a second larger profile configuration for placement on the first side of the annulus; and

thereafter exposing a second portion of the valve to position it on a second side of the annulus, the second portion moving to a second larger profile configuration on the second side of the annulus, the first and second portions providing a clamping force on the annulus.

2. The method of claim 1, wherein the first and second portions are biased towards each other so upon ejection of the second portion the first and second portions automatically move toward each other to clamp respective sides of the annulus.

3. The method of claim 1, further comprising the step of moving at least one of the first and second portions toward the other to clamp on respective sides of the annulus.

4. The method of claim 1, wherein the second portion includes a plurality of leaflets extending therefrom, the leaflets folded to a reduced profile in the insertion configuration of the valve.

5. The method of claim 4, further comprising the step of advancing a pusher to eject the replacement valve from the delivery instrument.

6. The method of claim 1, wherein the valve includes a tightening member and further comprising the step of tensioning the tightening member to place the first and second portions in closer proximity.

7. The method of claim 6, wherein the step of tensioning the tightening member comprises tensioning a suture connected to at least one of the first and second portions.

8. The method of claim 1, wherein the valve has a movable flow restricting portion attached to the second portion.

9. The method of claim 1, wherein the resecting instrument includes a pair of movable jaws extending from the flexible outer tube.

10. The method of claim 1, wherein the resecting instrument includes an end plate and a cutter, the valve resected by interaction of the cutter and plate.

11. The method of claim 1, wherein the delivery catheter, resecting instrument and delivery instrument are inserted through the femoral artery.

12. The method of claim 1, further comprising the step of suctioning the resected valve through the delivery catheter.

13. The method of claim 1, further comprising the step of suctioning the resected valve through the resecting instrument.

14. The method of claim 1, wherein the step of removing the resected valve removes the aortic valve.

15. The method of claim 1, wherein the step of removing the resected valve removes the mitral valve.

16. The method of claim 1, wherein the delivery catheter is inserted over a guidewire.

17. The method of claim 1, wherein the first and second portions are composed of shape memory material so that upon ejection from the delivery catheter, the respective first and second portions move to the shape memorized position.

18. The method of claim 17, wherein the step of ejecting the first and second portions allows the first and second portions to move to a substantially annular position.

19. The method of claim 1, wherein the first portion of the replacement valve includes a distal ring and the second portion includes a proximal ring, and in the insertion configuration the proximal ring is positioned proximal of the distal ring.

20. The method of claim 1, wherein the delivery catheter has a slit valve at the proximal and distal ends.