Methods for rapidly deployable surgical heart valves

Patent metadata

Field	Value
Publication number	US-12053377-B2
Application number	US-202218046475-A
Country	US
Kind code	B2
Filing date	Oct 13, 2022
Priority date	Sep 10, 2010
Publication date	Aug 6, 2024
Grant date	Aug 6, 2024

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.

First claim

What is claimed is:

1. A method of delivery and implant of a prosthetic heart valve system to a native heart valve annulus, comprising:
providing a prosthetic heart 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 frame in the expanded state being sized to match a particular size of native heart valve annulus, the heart valve having a plurality of flexible leaflets extending inward into the flow channel to provide occluding surfaces;
providing a delivery system including a balloon catheter with a balloon thereon, the balloon being longitudinally folded in an uninflated configuration and being calibrated to have an inflated configuration diameter when inflated to a predetermined fill pressure that expands the frame to the expanded state, and wherein the balloon is configured to axially foreshorten when inflated;
advancing the delivery system with the heart valve on a distal end thereof and the frame in its contracted state until the heart valve is located at an implant position adjacent the annulus;
inflating the balloon to expand the frame; and
deflating the balloon to permit elongation thereof.

2. The method of claim 1 , wherein the heart valve is mounted on a holder having a proximal hub and a lumen therethrough, and the delivery system includes a handle shaft having a shaft lumen for sliding passage of the balloon catheter and a distal end configured to mate with a proximal end of the valve holder, the method including advancing the balloon catheter through the lumens of the handle shaft and the holder to a location within the frame prior to inflating the balloon.

3. The method of claim 2 , wherein the distal end of the handle shaft and a proximal end of the valve holder have keyed structures that are unique for different sizes of valves such that a handle shaft for one valve size cannot mate with a valve holder of a different valve size.

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

5. The method of claim 2 , wherein the balloon on the balloon catheter has a midline, and the step of advancing the balloon catheter includes positioning the midline relative to the frame prior to inflation.

6. The method of claim 2 , wherein the step of advancing the delivery system includes bending the handle shaft.

7. The method of claim 1 , wherein the prosthetic valve has a non- expandable, non-collapsible support structure defining an inflow end to which a proximal end of the expandable frame secures, and wherein the contracted state of the frame is conical with a distal end smaller than the proximal end projecting in an inflow direction, wherein the step of inflating the balloon expands the distal end of the frame.

8. The method of claim 1 , wherein the balloon catheter has a balloon extension wire that extends from a proximal housing distally through the balloon catheter and is attached to a distal tip of the balloon, and when the balloon is inflated and axially foreshortens the balloon extension wire is simultaneously displaced proximally to compress a balloon extension spring in the proximal housing thus placing the balloon extension wire in compression.

9. The method of claim 1 , wherein the step of deflating the balloon further includes applying a vacuum to the balloon.

10. A method of delivery and implant of a prosthetic heart valve system to a native heart valve annulus, comprising:
providing a prosthetic heart 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 frame in the expanded state being sized to match a particular size of native heart valve annulus, the heart valve having a plurality of flexible leaflets extending inward into the flow channel to provide occluding surfaces;
providing a delivery system including a balloon catheter with a balloon thereon, the balloon being folded in an uninflated configuration having a length and a diameter, the balloon catheter having a balloon extension wire that extends from a proximal housing distally through the balloon catheter and is attached to a distal tip of the balloon, wherein the balloon is configured to axially foreshorten when inflated and the balloon extension wire is simultaneously displaced proximally to compress a balloon extension spring in the proximal housing thus placing the balloon extension wire in compression;
advancing the delivery system with the heart valve on a distal end thereof and the frame in its contracted state until the heart valve is located at an implant position adjacent the annulus;
inflating the balloon to expand the frame; and
deflating the balloon such that the balloon extension wire extends to displace the balloon extension wire distally and elongate the balloon.

11. The method of claim 10 , wherein a distal tip of the balloon extension wire has an enlargement embedded within the balloon wire tip that is heat bonded to the distal end of the balloon.

12. The method of claim 11 , wherein the distal tip of the balloon extension wire and balloon are formed of the same material selected from the group consisting of nylon and a high durometer thermoplastic elastomer.

13. The method of claim 10 , wherein the balloon extension wire is formed of nitinol, and further including a hypotube closely surrounding the balloon extension wire so as to stiffen the balloon extension wire, the hypotube extending within the balloon and terminating at or a short distance proximally beyond the proximal end of the balloon to avoid adding stiffness along a majority of the balloon extension wire and balloon catheter.

14. The method of claim 10 , wherein the balloon extension spring is configured to undergo complete compression to a solid length when the balloon inflates so as to provide a positive stop on proximal movement of the balloon extension wire and attached balloon distal tip.

15. The method of claim 10 , wherein the balloon is pleated, and wherein the spring force of the balloon extension spring is calibrated so as to elongate the pleated balloon to the length of the uninflated configuration.

16. The method of claim 10 , wherein the proximal housing has a luer fitting for connection of a source of inflation fluid, and wherein the balloon extension wire extends proximally out of the luer fitting for manual manipulation, the method including manually manipulating the balloon extension wire to facilitate elongation of the balloon.

17. The method of claim 10 , wherein the heart valve is mounted on a holder having a proximal hub and a lumen therethrough, and the delivery system includes a handle shaft having a shaft lumen for sliding passage of the balloon catheter and a distal end configured to mate with a proximal end of the valve holder, the method including advancing the balloon catheter through the lumens of the handle shaft and the holder to a location within the frame prior to inflating the balloon.

18. The method of claim 17 , further including packaging the heart valve mounted on the holder separately from the handle shaft and the balloon catheter.

19. The method of claim 10 , wherein the prosthetic valve has a non- expandable, non-collapsible support structure defining an inflow end to which a proximal end of the expandable frame secur

Assignees

• Edwards Lifesciences Corp

Inventors

• Pintor Rafael
• Scott Michael J
• Chien Thomas
• Chen Harvey H
• Yambao August R
• Farhat Lawrence J
• Phung Andrew
• Brunnett William C
• Cristea Carey L
• Walls Sara M
• Zheng Kevin W
• Kalam Faisal
• Zeng Qinggang

Classifications

• A61F2/2409

  Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442) · CPC title

• A61F2220/0083

  using hook and loop-type fasteners · CPC title

• A61F2220/0075

  sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable · CPC title

• A61F2220/005

  using adhesives · CPC title

• A61F2220/0025

  Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements · CPC title