METHODS OF RAPIDLY DEPLOYABLE SURGICAL HEART VALVES

• US 20170224484A1
• Filed: 11/23/2016
• Published: 08/10/2017
• Est. Priority Date: 09/10/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Chien, Thomas H., Farhat, Lawrence J., Kalam, Faisal, Scott, Michael J., Phung, Andrew, Brunnett, William C., Cristea, Carey L., Walls, Sara M., Zheng, Kevin W., Chen, Harvey H., Pintor, Rafael, Yambao, August R., Zeng, Qinggang
• Granted Patent: US 10,039,641 B2
• Time in Patent Office: Days
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0083 using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/006 modular

Abstract

A quick-connect heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The heart valve includes a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable frame, thereby enabling attachment to the annulus without sutures. A small number of guide sutures may be provided for aortic valve orientation. The prosthetic valve may be a commercially available valve with a sewing ring with the frame attached thereto. The frame may expand from a conical deployment shape to a conical expanded shape, and may include web-like struts connected between axially-extending posts. A system and method for deployment includes an integrated handle shaft and balloon catheter. A valve holder is stored with the heart valve and the handle shaft easily attaches thereto to improve valve preparation steps.

Claims

1. A method of delivery and implant of a prosthetic heart valve system, comprising:

providing a heart valve including a prosthetic valve having an expandable frame, the frame having a contracted state for delivery to an implant position and an expanded state configured for outward connection to the annulus and defining a flow channel therethrough, the heart valve having a plurality of flexible leaflets peripherally supported by the frame and extending inward into the flow channel to provide occluding surfaces, the heart valve being mounted on a holder having a proximal hub and a lumen therethrough;

connecting a distal end of a handle shaft to the proximal hub, the handle shaft having a lumen therethrough and a balloon catheter with a balloon therein, the distal end of the handle shaft and the proximal hub have complementary mating structure;

advancing the handle shaft with the heart valve on the distal end thereof and the frame in its contracted state until the heart valve is located at an implant position adjacent the annulus;

advancing the balloon catheter through the lumens of the handle shaft and the holder to a location within the frame; and

inflating the balloon to expand the frame.

2. The method of claim 1, further including packaging the heart valve mounted on the holder separately from the handle shaft and the balloon catheter.

3. The method of claim 1, wherein the prosthetic valve has a non-expandable, non-collapsible support structure defining an inflow end to which the expandable frame secures and projects in an inflow direction, and wherein the contracted state of the frame is conical with a larger end secured to the valve member.

4. The method of claim 3, wherein the balloon on the balloon catheter has a midline positioned near the distal end of the frame prior to inflation.

5. The method of claim 1, further including a safety member engaged between the balloon catheter and the handle shaft that prevents the step of advancing the balloon catheter until the safety member is disengaged.

6. The method of claim 5, wherein the safety member also prevents the step of inflating the balloon catheter until the safety member is disengaged.

7. The method of claim 1, wherein the step of inflating comprises inflating the balloon to a predetermined pressure calibrated to a particular valve size of the heart valve.

8. The method of claim 1, wherein the step of advancing the handle shaft includes bending the handle shaft.

9. The method of claim 1, wherein the complementary mating structure on the distal end of the handle shaft and the proximal hub comprises an internal shaped bore on the proximal hub which is sized and patterned to be keyed to an external shaped rim provided on the distal end of the handle shaft.

10. The method of claim 1, wherein the complementary mating structure on the distal end of the handle shaft and the proximal hub is unique to a valve size of the heart valve to ensure an inflated size of the balloon is calibrated to convert the frame to its expanded state, and wherein the handle shaft is a second handle shaft with a second balloon catheter having a second balloon, and prior to the step of connecting a distal end of the second handle shaft, the method includes:

connecting a distal end of a first handle shaft to the proximal hub, the first handle shaft having a lumen therethrough and a first balloon catheter with a first balloon therein, wherein the distal end of the first handle shaft and the proximal hub have mating structure unique to a valve size of the heart valve to ensure an inflated size of the first balloon is calibrated to convert the frame to its expanded state;

advancing the first handle shaft with the heart valve on the distal end thereof and the frame in its contracted state until the heart valve is located at an implant position adjacent the annulus;

advancing the first balloon catheter through the lumens of the first handle shaft and the holder to within the heart valve;

attempting to inflate the first balloon to expand the frame;

deflating the first balloon and retracting the first balloon catheter from within the heart valve; and

performing the step of connecting a distal end of the second handle shaft.

11. The method of claim 1, wherein the complementary mating structure on the distal end of the handle shaft and the proximal hub is unique to a valve size of the heart valve to ensure an inflated size of the balloon is calibrated to convert the frame to its expanded state, and wherein the balloon catheter is a second balloon catheter having a second balloon, and prior to the step of advancing the second balloon catheter, the method includes:

advancing the first handle shaft with the heart valve on the distal end thereof and the frame in its contracted state until the heart valve is located at an implant position adjacent the annulus;

advancing the first balloon catheter through the lumens of the first handle shaft and the holder to within the heart valve;

attempting to inflate the first balloon to expand the frame;

deflating the first balloon and retracting the first balloon catheter from within the heart valve;

removing the first balloon catheter from the handle shaft; and

inserting the second balloon catheter into the handle shaft and performing the step of advancing the second balloon catheter.

12. A method of delivery and implant of a prosthetic heart valve system, comprising:

providing a heart valve including a prosthetic valve having an expandable frame, the frame having a contracted state for delivery to an implant position and an expanded state configured for outward connection to the annulus and defining a flow channel therethrough, the heart valve having a plurality of flexible leaflets peripherally supported by the frame and extending inwardly into the flow channel and angled toward an outflow end of the heart valve to provide a one-way fluid occluding surfaces that permits flow only in the outflow direction, the heart valve being mounted on a holder having a proximal hub and a lumen therethrough;

connecting a balloon introducer sleeve to the holder from an inflow end of the heart valve so that it extends through and parts the flexible leaflets;

fixing and coaxially aligning a distal end of a handle shaft with respect to the holder, the handle shaft having a lumen therethrough and a balloon catheter with a balloon therein;

advancing the handle shaft with the heart valve on the distal end thereof and the frame in its contracted state until the heart valve is located at an implant position adjacent the annulus;

advancing the balloon catheter through the lumen of the handle shaft and through the balloon introducer sleeve to a location within the frame; and

inflating the balloon to expand the frame.

13. The method of claim 12, further including packaging the heart valve mounted on the holder separately from the handle shaft and the balloon catheter.

14. The method of claim 12, wherein the prosthetic valve has a non-expandable, non-collapsible support structure defining an inflow end to which the expandable frame secures and projects in an inflow direction, and wherein the contracted state of the frame is conical with a larger end secured to the valve member.

15. The method of claim 14, wherein the balloon on the balloon catheter has a midline positioned near the distal end of the frame prior to inflation.

16. The method of claim 12, further including a safety member engaged between the balloon catheter and the handle shaft that prevents the step of advancing the balloon catheter until the safety member is disengaged.

17. The method of claim 16, wherein the safety member also prevents the step of inflating the balloon catheter until the safety member is disengaged.

18. The method of claim 12, wherein the step of inflating comprises inflating the balloon to a predetermined pressure calibrated to a particular valve size of the heart valve.

19. The method of claim 12, wherein the step of advancing the handle shaft includes bending the handle shaft.

20. The method of claim 12, wherein the balloon introducer sleeve firmly connects to the lumen of the holder and has a length sufficient to extend proximally from the valve holder, and wherein the distal end of the handle shaft is configured to mate with a proximal end of the balloon introducer sleeve.