Methods and apparatuses for deploying minimally-invasive heart valves

• US 7,556,646 B2
• Filed: 09/13/2001
• Issued: 07/07/2009
• Est. Priority Date: 09/13/2001
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Pease, Matthew Lane, Heneveld, Scott Hyler Sr., Walsh, Brandon G., Yang, Jibin
• Primary Examiner(s): McDermott; Corrine M
• Assistant Examiner(s): Prone; Christopher D
• Application Number:
  US09/951,701
• Publication Number:
  US 20030050694A1
• Time in Patent Office: 2,854 Days
• Field of Search: 623/211, 606191-195, 606/198, 606/108, 294/94, 294/96, 294/100, 604106-109
• 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 includes a deployment mechanism that engages the valve and regulates the rate of expansion of both the proximal and distal ends thereof. The deployment mechanism may include a plurality of distal fingers and a plurality of proximal fingers that engage the end portions of the heart valve. Controlled radial movement of the fingers regulates the expansion of the heart valve such that the proximal and distal ends radially expand at the same rate. 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:

an expandable prosthetic heart valve including a stent body having a plurality of biological tissue leaflets incorporated therein;

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 for regulating self-expansion of the prosthetic heart valve, the proximal deployment member configured to apply a radially inward force along a proximal end portion of the stent body while the proximal deployment member engages an outer surface of the proximal end portion, and the distal deployment member configured to apply a radially inward force along a distal end portion of the stent body while the distal deployment member engages an outer surface of the distal end portion; and

an actuating shaft extending though 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 associated 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 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.

9. 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.

10. The system of claim 1, wherein:

the distal deployment member comprises distal fingers extending proximally toward a distal region of engagement with the stent body; and

the proximal deployment member comprises proximal fingers extending distally toward a proximal region of engagement with the stent body;

wherein the proximal and distal fingers are configured to engage and limit expansion of the stent body.

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

a self-expandable prosthetic heart valve including;

a self-expandable valve body having a plurality of biological tissue leaflets incorporated therein;

a catheter for advancing the self expandable prosthetic 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 applying an inward radial force along the valve body while engaging an outer surface of the valve body, for regulating the rate of self-expansion of the heart valve such that proximal and distal ends of the valve body are expanded together, thereby allowing the valve body to maintain a generally tubular shape during self-expansion.

12. The system of claim 11, further including:

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

13. The system of claim 12, wherein the means for expanding the heart valve from its initial expanded configuration to a final expanded configuration comprises a balloon.

14. The system of claim 11, 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.

15. The system of claim 11, wherein the means for applying the inward radial force comprises:

distal fingers extending proximally from a distal portion of the means for permitting; and

proximal fingers extending distally from a proximal portion of the means for permitting;

wherein the proximal and distal fingers are configured to engage and limit expansion of the heart valve.

16. 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 by applying an inward radial force against outer surfaces of proximal and distal ends of the heart valve such that the expansion rates of the proximal and distal ends of the heart valve are equilibrated.

17. The method of claim 16, 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.

18. The method of claim 17, 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.

19. The method of claim 18, 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.

20. The method of claim 19, 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.

21. The method of claim 16, further including:

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

22. The method of claim 21, 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.

23. The method of claim 22, wherein the valve inflation balloon is separate from the deployment mechanism and is introduced into the valve after at least a partial expansion thereof.

24. The method of claim 16, further including:

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

25. The method of claim 24, wherein the step of stabilizing the heart valve comprises inflating a stabilization balloon.

26. The method of claim 16, wherein the regulating further comprises applying the inward radial force with a plurality of projections that extend axially toward each other from axially spaced locations along an axis of the heart valve.

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

an expandable prosthetic heart valve;

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 configured to move radially and engage outer surfaces of the heart valve while limiting self expansion of the prosthetic heart valve;

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

wherein the heart valve deployment mechanism is a modular unit stored with the prosthetic heart valve and coupled to the distal ends of the catheter shaft and actuating shaft at the time of delivery.

28. The system of claim 27, wherein the deployment members comprise fingers each having a first end and a second end, wherein the first end is pivotally coupled to the deployment mechanism and the second end is configured to engage the prosthetic heart valve for selectively limiting self-expansion.

29. The system of claim 27, 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.

30. The system of claim 27, wherein:

the distal deployment member extends proximally toward a region of engagement with the heart valve; and

the proximal deployment member extends distally toward a region of engagement with the heart valve.