Methods and apparatuses for deploying minimally-invasive heart valves

• US 20030050694A1
• Filed: 09/13/2001
• Published: 03/13/2003
• Est. Priority Date: 09/13/2001
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Walsh, Brandon G., Yang, Jibin, Pease, Matthew Lane, Heneveld, Scott Hyler Sr.
• Granted Patent: US 7,556,646 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion

Abstract

A system for delivering and deploying a self-expandable heart valve to a site of implantation such as the aortic annulus includes a deployment mechanism that engages the valve and regulates the rate of expansion of both the proximal and distal ends thereof. The heart valve may be a rolled-type valve and the deployment mechanism may include a plurality of distal fingers and a plurality of proximal fingers that engage the outer layer of the heart valve. Controlled radial movement of the fingers regulates the unwinding of the rolled heart valve. The fingers may be removed prior to inflation of a balloon to fully expand the valve, or the fingers may be repositioned to the inside of the valve for this purpose. The deployment mechanism may include an umbrella structure that forces the rolled valve outward into its fully expanded configuration. Alternatively, a gear shaft that engages one or more gear tracks on the valve may be utilized to regulate expansion of the valve. A stabilization balloon may be used to axially and radially locate the deployment mechanism relative to the site of implantation. Methods of operation of the delivery and deployment mechanism include regulating the rate of self-expansion of the valve and forcing the valve outward into its fully expanded configuration utilizing the same or different means.

Claims

1. A system for delivering and deploying an expandable prosthetic heart valve, comprising:

a catheter shaft having a proximal end and a distal end and a lumen therethrough extending along an axis;

a heart valve deployment mechanism extending axially from the distal end of the catheter shaft, the deployment mechanism including spaced apart proximal and distal deployment members; and

an actuating shaft extending through the lumen of the catheter shaft operable to actuate at least one of the proximal and distal deployment members.

2. The system of claim 1, wherein the deployment members are radially movable and comprise fingers each pivoted at one end thereof to the deployment mechanism.

3. The system of claim 2, wherein there are at least two proximal deployment fingers and at least two distal deployment fingers, and wherein the deployment fingers are axially movable.

4. The system of claim 1, wherein the deployment members are radially movable and there are two of the actuating shafts, a first actuating shaft being operable to radially displace the proximal deployment members and a second actuating shaft being operable to radially displace the distal deployment members, and wherein the first and second actuating shafts are concentrically disposed to slide with respect one another.

5. The system of claim 1, wherein the deployment mechanism comprises a proximal collet with respect to which the proximal deployment members pivot, and a distal collet with respect to which the distal deployment members pivot, and wherein the proximal collet and distal collet are relatively axially movable.

6. The system of claim 5, further including a first actuating shaft extending within a cavity in the proximal collet and a first driver attached thereto that acts upon the proximal deployment members to pivot them with respect to the proximal collet, and a second actuating shaft extending through the first actuating shaft and into a cavity in the distal collet and having a second driver attached thereto that acts upon the distal deployment members to pivot them with respect to the distal collet.

7. The system of claim 6, wherein each deployment member pivots about a point that is fixed with respect to the associate collet and includes structure that engages cooperating structure on the associated driver, and wherein axial movement of the driver rotates the structure about the pivot point, thus rotating the deployment member.

8. The system of claim 6, wherein each deployment member has a pin fixed with respect thereto that is received within a corresponding slot in the associated driver, and each collet includes a plurality of pins fixed with respect thereto that are received within corresponding slots in the associated deployment members, and wherein axial movement of the driver displaces the pins fixed with respect to the deployment members and causes the deployment members to pivot outward due to a camming action of the deployment member slots over the collet pins.

9. The system of claim 1, wherein each deployment member comprises a pad that is coupled to a respective proximal and distal end cap disposed along the catheter shaft, the pads being radially displaceable with respect to the associated end cap, and wherein the proximal and distal end caps are axially movable with respect to each other.

10. The system of claim 9, wherein there are two of the actuating shafts, each shaft controlling a plurality of flexible tongs having column strength that extend between one of the end caps and attach to the associated pads, wherein axial movement of each shaft shortens or lengthens the radial extent of the flexible tongs controlled thereby so as to radially displace the attached pads.

11. The system of claim 1, wherein each deployment member comprises a gear that engages a gear track on the heart valve.

12. The system of claim 1, further including a stabilization balloon provided on the catheter shaft proximal to the deployment mechanism and sized to expand and contact a surrounding vessel adjacent the site of implantation.

13. The system of claim 12, wherein the stabilization balloon is shaped so as to permit blood flow past it in its expanded configuration.

14. The system of claim 13, wherein the stabilization balloon includes multiple outwardly extending lobes.

15. The system of claim 1, wherein the heart valve deployment mechanism is a modular unit coupled to the distal ends of the catheter shaft and actuating shaft.

16. A system for delivering and deploying a self-expandable prosthetic heart valve to a site of implantation, comprising:

a catheter for advancing the heart valve in a contracted configuration to the site of implantation;

means on the catheter for permitting the heart valve to self-expand from its contracted configuration to an initial expanded configuration in contact with the surrounding site of implantation; and

means for regulating the rate of self-expansion of the heart valve.

17. The system of claim 16, further including:

means for expanding the heart valve from its initial expanded configuration to a final expanded configuration.

18. The system of claim 17, wherein the means for expanding the heart valve from its initial expanded configuration to a final expanded configuration comprises a balloon.

19. The system of claim 17, wherein the means for expanding the heart valve from its initial expanded configuration to a final expanded configuration is the same as the means for regulating the rate of self-expansion of the heart valve.

20. The system of claim 19, wherein the means for expanding the heart valve from its initial expanded configuration to its final expanded configuration and the means for regulating the rate of self-expansion of the heart valve comprise a plurality of radially movable fingers, wherein there is a plurality of distal radially movable fingers spaced from a plurality of proximal radially movable fingers, and wherein radial movement of the distal and proximal fingers is separately controlled.

21. The system of claim 20, wherein the means for expanding the heart valve from its initial expanded configuration to its final expanded configuration comprises a distal collet about which the distal radially movable fingers pivot and a proximal collet about which the proximal radially movable fingers pivot, wherein the distal and proximal collets are axially movable with respect to each other.

22. The system of claim 21, wherein each of the fingers pivots about a point fixed with respect to the associated collet.

23. The system of claim 20, wherein each of the fingers has a flexible claw that engages the heart valve, and wherein the means for expanding the heart valve from its initial expanded configuration to its final expanded configuration comprises structure for maintaining the axial positions of flexible claws upon radial movement of the fingers.

24. The system of claim 16, wherein the means for expanding the heart valve from its initial expanded configuration to its final expanded configuration and the means for regulating the rate of self-expansion of the heart valve comprises a gear mechanism that engages both the distal and proximal ends of the heart valve.

25. The system of claim 24, wherein the heart valve is of the rolled type having multiple wound layers and the gear mechanism includes a gear shaft that engages an inner layer of the spirally wound heart valve and a retaining bar that engages an outer layer of the spirally wound heart valve, wherein the distance between the gear shaft and retaining bar is adjustable.

26. The system of claim 16, further including a stabilization device provided on the catheter proximal to the means on the catheter for permitting the heart valve to self-expand, the device being sized to expand and contact a surrounding vessel adjacent the site of implantation.

27. The system of claim 26, wherein the stabilization device is a balloon shaped so as to permit blood flow past it in its expanded configuration.

28. A system for delivering and deploying an expandable prosthetic heart valve to a site of implantation, comprising:

a catheter for advancing the heart valve in a contracted configuration to the site of implantation;

a stabilization device provided on the catheter sized to expand and contact a surrounding vessel adjacent the site of implantation; and

means on the catheter distal to the stabilization device for expanding the heart valve from its contracted configuration to an initial expanded configuration in contact with the surrounding site of implantation.

29. The system of claim 28, wherein the stabilization device is a balloon shaped so as to permit blood flow past it in its expanded configuration.

30. The system of claim 29, wherein the stabilization balloon includes multiple outwardly extending lobes.

31. The system of claim 28, further including means for regulating the rate of self-expansion of the heart valve.

32. The system of claim 31, further including:

means for expanding the heart valve from its initial expanded configuration to a final expanded configuration.

33. The system of claim 32, wherein the means for expanding the heart valve from its initial expanded configuration to a final expanded configuration comprises a balloon.

34. The system of claim 32, wherein the means for expanding the heart valve from its initial expanded configuration to a final expanded configuration is the same as the means for regulating the rate of self-expansion of the heart valve.

35. A method for delivering and deploying a self-expandable prosthetic heart valve to a site of implantation, comprising:

advancing the heart valve in a contracted configuration to the site of implantation;

permitting the heart valve to self-expand from its contracted configuration to an initial expanded configuration in contact with the surrounding site of implantation; and

regulating the rate of self-expansion of the heart valve.

36. The method of claim 35, wherein the step of advancing the heart valve in a contracted configuration to the site of implantation comprises providing a heart valve deployment mechanism that in one operating mode maintains the heart valve in the contracted configuration, and in another operating mode regulates the rate of self-expansion of the heart valve.

37. The method of claim 36, wherein the heart valve deployment mechanism includes a plurality of proximal deployment members that engage a proximal end of the valve, and a plurality of distal deployment members that engage a distal end of the valve, and wherein coordinated radial movement of the proximal and distal deployment members regulates the rate of self-expansion of the heart valve.

38. The method of claim 37, wherein the deployment members comprise fingers that pivot, and wherein the method includes regulating the rate of pivot of the deployment members to regulate the rate of self-expansion of the heart valve.

39. The method of claim 38, wherein the heart valve deployment mechanism includes a proximal collet about which the proximal fingers pivot and a distal collet about which the distal fingers pivot, and wherein the method includes displacing the proximal and distal collets axially during pivoting of the proximal and distal fingers.

40. The method of claim 35, wherein the heart valve deployment mechanism includes a gear shaft having a plurality of gear teeth that engage a gear track provided on the heart valve, wherein the rate of self-expansion of the heart valve is regulated by regulating the rotational speed of the gear shaft.

41. The method of claim 35, further including:

expanding the heart valve from its initial expanded configuration to a final expanded configuration.

42. The method of claim 41, further including providing a catheter-based valve deployment mechanism having deployment members that both regulate the rate of self-expansion of the heart valve and expand the heart valve from its initial expanded configuration to its final expanded configuration.

43. The method of claim 41, further including providing a catheter-based valve deployment mechanism having deployment members that regulate the rate of self-expansion of the heart valve and an inflation balloon that expands the heart valve from its initial expanded configuration to its final expanded configuration.

44. The method of claim 43, wherein the valve inflation balloon is separate from the deployment mechanism and is introduced into the valve after at least a partial expansion thereof.

45. The method of claim 35, further including:

stabilizing the heart valve in its contracted configuration adjacent the site of implantation prior to permitting the heart valve to self-expand.

46. The method of claim 45, wherein the step of stabilizing the heart valve comprises inflating a stabilization balloon.

47. The method of claim 46, further including permitting blood flow past the inflated stabilization balloon.

48. The method of claim 35, further including converting the heart valve from its initial expanded configuration to a smaller size.