Systems for rapidly deployable surgical heart valves

• US 10,722,358 B2
• Filed: 08/06/2018
• Issued: 07/28/2020
• Est. Priority Date: 09/10/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Pintor, Rafael, Scott, Michael J., Chien, Thomas H., 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
• Primary Examiner(s): Prebilic, Paul B
• Application Number:
  US16/056,252
• Publication Number:
  US 20180338828A1
• Time in Patent Office: 722 Days
• Field of Search: 623 211
• 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 system for delivering a prosthetic heart valve, comprising:

a heart valve including a prosthetic valve and an expandable frame having a contracted state for delivery to an implant position and an expanded state;

a valve holder attached to the heart valve and having a through passage; and

a delivery assembly packaged separately from the heart valve and valve holder, comprising;

a balloon catheter having a balloon; and

a handle shaft having a lumen for passage of the balloon catheter and a distal end configured to mate with a proximal end of the valve holder such that the balloon can be advanced distally through the handle shaft, through the valve holder and within the heart valve, and 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 delivery assembly for one valve size cannot mate with a valve holder of a different valve size.

2. The system of claim 1, wherein the prosthetic valve has an inner frame assembly defining a non-expandable, non-collapsible orifice, and the expandable frame extends from an inflow end thereof.

3. The system of claim 1, wherein the heart valve includes a plurality of flexible leaflets that provide fluid occluding surfaces across the orifice, the system further including a balloon introducer sleeve coupled to the valve holder that extends through the flexible leaflets and prevents contact between the balloon catheter and the flexible leaflets when the balloon catheter advances within the heart valve.

4. The system of claim 1, wherein the keyed structures comprise an internal star-shaped bore on the valve holder and an external star-shaped rim on the distal end of the handle shaft, wherein different star-shaped patterns of the mating bore and rim are provided for different sizes of valves.

5. The system of claim 1, wherein the keyed structures engage at a plurality of rotational orientations which require rotation of the distal end of the handle shaft no more than 30°

relative to the proximal end of the valve holder.

6. The system of claim 1, wherein the distal end of the handle shaft has a tubular holder adapter including an external shape on a distal end that forms one of the keyed structures and the valve holder has a bore shaped to mate with the external shape of the holder adapter, wherein different shapes of the mating holder adapter and bore are provided for different sizes of valves.

7. The system of claim 5, wherein the heart valve includes a plurality of flexible leaflets that provide fluid occluding surfaces across the orifice, the system further including a balloon introducer sleeve defining a throughbore and coupled to the valve holder that extends through the flexible leaflets and prevents contact between the balloon catheter and the flexible leaflets when the balloon catheter advances within the heart valve, the balloon introducer sleeve having a length sufficient to extend proximally from the valve holder and defining a proximal end to which the holder adapter may be secured.

8. The system of claim 1, wherein the handle shaft is malleable and can be bent and retain its bent shape.

9. The system of claim 8, wherein the malleable handle shaft is made of aluminum.

10. The system of claim 8, wherein the balloon catheter has an inflation tube that extends through the lumen of the handle shaft and an OD of the inflation tube is sized more than 90% the ID of the handle shaft lumen.

11. A system for delivering a prosthetic heart valve, comprising:

a heart valve including a prosthetic valve and an expandable frame having a contracted state for delivery to an implant position and an expanded state;

a valve holder assembly attached to the heart valve and having a through passage, the valve holder assembly defining a proximal end; and

a delivery assembly packaged separately from the heart valve and valve holder assembly, comprising;

a balloon catheter having a balloon; and

a handle shaft having a lumen for passage of the balloon catheter and a distal end configured to mate with the proximal end of the valve holder assembly such that the balloon can be advanced distally through the handle shaft, through the valve holder assembly and within the heart valve, and wherein the distal end of the handle shaft has a tubular holder adapter that fits over the proximal end of the valve holder assembly, the holder adapter and proximal end of the valve holder assembly having an interfering structure thereon, the handle shaft also having a locking sleeve that slides longitudinally over the holder adapter and prevents disengagement of the interfering structure.

12. The system of claim 11, wherein the heart valve includes a plurality of flexible leaflets that provide fluid occluding surfaces across the orifice, the valve holder assembly including a valve holder sutured to the heart valve and a balloon introducer sleeve defining the through passage and coupled to the valve holder that extends through the flexible leaflets and prevents contact between the balloon catheter and the flexible leaflets when the balloon advances within the heart valve, the balloon introducer sleeve having a length sufficient to extend proximally from the valve holder so as to define the proximal end to which the holder adapter is secured.

13. The system of claim 12, wherein the proximal end of the balloon introducer sleeve has a circular groove and the holder adapter has internal bumps that engage the circular groove, the circular groove and internal bumps forming the interfering structure.

14. The system of claim 12, wherein the balloon introducer sleeve has an enlarged first end with an internal bore defining a star-shaped profile configured to attach to a handling rod having a corresponding outer profile and permit positive rotational engagement therebetween, and the balloon introducer sleeve has external threads that mate with internal threads on a throughbore of the valve holder.

15. The system of claim 11, wherein the proximal end of the valve holder assembly has a circular groove and the holder adapter has internal bumps that engage the circular groove, the circular groove and internal bumps forming the interfering structure.

16. The system of claim 11, wherein the holder adapter includes a plurality of longitudinally-extending cantilevered fingers terminating at distal ends, wherein each of the fingers has one of the internal bumps thereon.

17. The system of claim 11, wherein a distal end of the handle shaft and the proximal end of the valve holder assembly further include mating keyed elements that are unique for each different size of valve such that a delivery assembly for one valve size cannot mate with a valve holder assembly of a different valve size.

18. The system of claim 11, wherein the expandable frame extends from an inflow end of the prosthetic valve, and wherein the balloon of the balloon catheter is positioned within the expandable frame when the balloon catheter is fully advanced within the handle shaft.

19. The system of claim 18, wherein the balloon has a visible midline, that in an advanced position of the balloon, is located within 1-2 mm of the distalmost end of the expandable frame of the heart valve.

20. The system of claim 19, wherein the handle shaft is malleable and can be bent and retain its bent shape, and wherein the balloon catheter has an inflation tube that extends through the lumen of the handle shaft and an OD of the inflation tube is sized more than 90% the ID of the handle shaft lumen.