Method of implanting a self-expandable prosthetic heart valve

• US 9,320,598 B2
• Filed: 10/09/2012
• Issued: 04/26/2016
• Est. Priority Date: 03/18/2003
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Iobbi, Mario
• Primary Examiner(s): Prebilic, Paul
• Application Number:
  US13/648,119
• Publication Number:
  US 20130096671A1
• Time in Patent Office: 1,295 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A method of implanting a collapsible prosthetic heart valve is disclosed. The prosthetic heart valve includes three biological leaflets mounted within a self-expanding tubular leaflet frame formed of nitinol. The method comprises loading a collapsed prosthetic heart valve into a distal end of a delivery tube. The distal end of the delivery tube is inserted into a vasculature of a patient and positioned proximal to an aortic valve. The prosthetic heart valve is expelled into an annulus of the aortic valve and allowed to self-expand to a first diameter. A balloon is then inflated within the prosthetic heart valve for expanding the prosthetic heart valve to a second diameter, wherein the second diameter is larger than the first diameter, thereby securely implanting the prosthetic heart valve within the annulus of the aortic valve.

Claims

1. A method of implanting a collapsible prosthetic heart valve, comprising:

loading a collapsed prosthetic heart valve into a distal end of a delivery tube, the prosthetic heart valve comprising a self-expanding tubular leaflet frame formed of nitinol, the prosthetic heart valve further comprising three biological leaflets, each leaflet having a free edge and an outer edge, the free edges arranged to coapt within the prosthetic heart valve to provide a one-way occlusion and each outer edge attached to the leaflet frame;

inserting the distal end of the delivery tube into a vasculature of a patient;

positioning the distal end of the delivery tube proximal to an aortic valve;

expelling the prosthetic heart valve into an annulus of the aortic valve;

allowing the prosthetic heart valve to self-expand to a first diameter and into contact with the annulus of the aortic valve, wherein the tubular leaflet frame includes three cusp positioners that spring outward into the three valve sinuses and help rotationally orient the valve during the step of allowing the prosthetic heart valve to self-expand to a first diameter; and

inflating a balloon within the prosthetic heart valve for expanding the prosthetic heart valve to a second diameter, the second diameter larger than the first diameter, thereby securely implanting the prosthetic heart valve within the annulus of the aortic valve.

2. The method of claim 1, wherein the leaflet frame further comprises three U-shaped cusp regions and three commissure regions, the three U-shaped cusp regions alternating with the three commissure regions and wherein the outer edges of the leaflets are secured along the cusp regions.

3. The method of claim 2, wherein the leaflet frame further comprises three U-shaped cusp positioners, each cusp positioner rigidly fixed with respect to the leaflet frame and extending radially farther outward than the commissure regions.

4. The method of claim 3, further comprising positioning the cusp positioners in sinuses of the aortic valve for rotationally orienting the prosthetic heart valve.

5. The method of claim 4, wherein the three biological leaflets are made of bovine pericardium.

6. The method of claim 5, wherein the distal end of the delivery tube is inserted through a femoral artery, a subclavian artery, or an axillary artery.

7. The method of claim 1, wherein the prosthetic heart valve is expelled into an annulus of the aortic valve at a location inferior of a final implant position and wherein the prosthetic heart valve is further displaced in a superior direction to the final implant position.

8. The method of claim 1, further comprising re-collapsing the prosthetic heart valve after allowing the prosthetic heart valve to self-expand.

9. The method of claim 1, further comprising loading the collapsed prosthetic heart valve on the balloon.

16. The method of claim 1, wherein the tubular leaflet frame further comprises three U-shaped cusp regions and three commissure regions, the three U-shaped cusp regions alternating with the three commissure regions and wherein the outer edges of the leaflets are secured along the cusp regions, and wherein each cusp positioner is rigidly fixed with respect to the leaflet frame and extending radially farther outward than the commissure regions.

17. The method of claim 16, wherein the three cusp positioners are U-shaped.

10. A method of implanting a collapsible prosthetic heart valve, comprising:

permitting a prosthetic heart valve to self-expand to a first diameter and into contact with a surrounding heart valve annulus, the self-expanding prosthetic heart valve comprising a frame displaying hysteresis in the elastic or superelastic region; and

physically expanding the prosthetic heart valve to a second diameter, the second diameter larger than the first diameter, wherein the heart valve annulus is the aortic valve annulus and there are three valve sinuses adjacent thereto, and the prosthetic heart valve has a self-expanding tubular leaflet frame including three cusp positioners that spring outward into the three valve sinuses and help rotationally orient the valve during the step of permitting the prosthetic heart valve to self-expand to the first diameter.

11. The method of claim 10, wherein the frame of the prosthetic heart valve is a collapsible shape-memory-alloy leaflet frame having an austenitic transition temperature less than body temperature, the method further including collapsing the prosthetic heart valve at a temperature at or below a martensitic transition temperature of the leaflet frame.

12. The method of claim 11, wherein collapsing the prosthetic heart valve comprises immersing the prosthetic heart valve in an ice bath to a temperature less than or equal to the martensitic transition temperature of the leaflet frame.

13. The method of claim 10, wherein physically expanding the prosthetic heart valve comprises inflating a balloon within the prosthetic heart valve.

14. The method of claim 10, wherein the tubular leaflet frame is formed of nitinol and further comprises three U-shaped cusp regions and three commissure regions, the three U-shaped cusp regions alternating with the three commissure regions and wherein the outer edges of the leaflets are secured along the cusp regions, and wherein each cusp positioner is rigidly fixed with respect to the leaflet frame and extending radially farther outward than the commissure regions.

15. The method of claim 14, wherein the three cusp positioners are U-shaped.

18. A method of implanting a collapsible prosthetic heart valve, comprising:

the prosthetic heart valve comprising a frame displaying hysteresis in the elastic or superelastic region, wherein the frame of the prosthetic heart valve is a collapsible leaflet frame including three cusp regions on an inflow end of the prosthetic heart valve intermediate three commissure regions on an outflow end of the prosthetic heart valve, the prosthetic heart valve further including three cusp positioners on the outflow end and intermediate the three commissure regions;

connecting a holder having flexible members to the commissure regions of the prosthetic heart valve;

collapsing the prosthetic heart valve within a delivery tube;

advancing the prosthetic heart valve within the delivery tube to an aortic valve annulus;

expelling the prosthetic heart valve from the delivery tube by relative movement therebetween;

permitting the prosthetic heart valve to self-expand to a first diameter and into contact with a surrounding heart valve annulus;

positioning the prosthetic heart valve utilizing the flexible members of the holder such that the cusp positioners contact the two coronary and one non-coronary sinuses of the ascending aorta without blocking the coronary ostia; and

physically expanding the prosthetic heart valve to a second diameter, the second diameter larger than the first diameter.

19. The method of claim 18, further including:

connecting flexible members of the holder to the cusp positioners and utilizing the flexible members to position the prosthetic heart valve.

20. The method of claim 18, further including using the flexible members to rotate the prosthetic heart valve while positioning the prosthetic heart valve.

21. The method of claim 20, further including using the flexible members to re-collapse the prosthetic heart valve after permitting the prosthetic heart valve to self-expand.

22. The method of claim 18, wherein the three cusp regions are U-shaped and the outer edges of the leaflets are secured along the U-shaped cusp regions.

23. The method of claim 22, wherein the three cusp positioners are U-shaped, and each cusp positioner is rigidly fixed with respect to the leaflet frame and extends radially farther outward than the commissure regions.

24. The method of claim 18, wherein the frame of the prosthetic heart valve is a collapsible shape-memory-alloy leaflet frame having an austenitic transition temperature less than body temperature, the method further including collapsing the prosthetic heart valve at a temperature at or below a martensitic transition temperature of the leaflet frame.