Systems for rapidly deploying surgical heart valves

• US 8,641,757 B2
• Filed: 06/23/2011
• Issued: 02/04/2014
• 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, Chen, Harvey H., Yambao, August R., Farhat, Lawrence J., Phung, Andrew, Brunnett, William C., Cristea, Carey L., Kalam, Faisal, Zeng, Qinggang, Walls, Sara M., Zheng, Kevin W.
• Primary Examiner(s): EREZO, DARWIN P
• Application Number:
  US13/167,639
• Publication Number:
  US 20120065729A1
• Time in Patent Office: 957 Days
• Field of Search: 623/2.1, 623/2.11, 623/2.14, 623/2.17, 623/2.18
• 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 2/2418 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 having an inner frame assembly defining a non-expandable, non-collapsible orifice, the heart valve further including an expandable frame extending from an inflow end thereof, the frame having a contracted state for delivery to an implant position and an expanded state;

a valve holder attached to the heart valve;

a balloon catheter having a balloon; and

a malleable handle shaft that can be bent and retain its bent shape configured to mate with a proximal end of the valve holder and having a lumen for passage of the balloon catheter, the balloon extending distally through the handle shaft, past the valve holder and through the heart valve.

2. The system of claim 1, wherein the heart valve attached to the valve holder is packaged separately from the handle shaft and the balloon catheter.

3. The system of claim 1, wherein the malleable handle shaft is made of aluminum.

4. The system of claim 1, 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 close to an ID of the handle shaft lumen.

5. 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 extends through the heart valve.

6. The system of claim 1, wherein a distal end of the handle shaft and proximal end of the valve holder have keyed structures that are unique for each different size of valve such that a handle shaft and balloon catheter assembly for one valve size cannot mate with a valve holder of a different valve size.

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

a valve holder having a through passage;

a heart valve including a prosthetic valve having an inner frame assembly defining a non-expandable, non-collapsible orifice and a plurality of flexible leaflets that provide fluid occluding surfaces across the orifice, the leaflets coapting together in an outflow direction, the heart valve being attached to the valve holder;

a balloon introducer sleeve that engages the through passage of and extends through the valve holder, and has a length sufficient to extend within the flexible leaflets and such that a proximal end thereof projects beyond an outflow end of the leaflets and proximally from the valve holder, the balloon introducer sleeve defining a throughbore;

a balloon catheter having a balloon; and

a handle shaft configured to mate with the proximal end of the balloon introducer sleeve and having a lumen for passage of the balloon catheter such that the balloon may pass distally through the handle shaft lumen and through the balloon introducer sleeve throughbore and at least a portion beyond the heart valve inner frame assembly without contacting the flexible leaflets.

8. The system of claim 7, wherein a distal end of the handle shaft is also configured to mate with a proximal end of the valve holder with keyed elements that are unique for each different size of valve such that a handle shaft and balloon catheter assembly for one valve size cannot mate with a valve holder of a different valve size.

9. The system of claim 8, wherein the keyed elements 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.

10. The system of claim 7, wherein a distal end of the handle shaft includes an adapter having a bore sized to closely receive the proximal end of the balloon introducer sleeve and the adapter and balloon introducer sleeve have cooperating features that interfere axially to prevent their decoupling.

11. The system of claim 10, further including a locking sleeve that surrounds and frictionally engages the adapter to maintain engagement of the cooperating features between the adapter and balloon introducer sleeve.

12. The system of claim 7, wherein the heart valve further includes an expandable frame extending from an inflow end thereof, the expandable frame having a contracted state for delivery to an implant position and an expanded state, 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.

13. The system of claim 7, wherein the balloon introducer sleeve has an enlarged first end with an internal bore defining a non-circular 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 the through passage of the valve holder.

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

a heart valve including a prosthetic valve having an inner frame assembly defining a non-expandable, non-collapsible orifice, the heart valve further including an expandable frame extending from an inflow end thereof, the 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, the valve holder being primarily on an outflow/proximal side of the heart valve; and

an integrated assembly of a handle shaft and balloon catheter, including;

a handle shaft having a handpiece on a proximal end and a distal adapter configured to mate with a proximal end of the valve holder, wherein relative axial positions of the handpiece and adapter are fixed, the handle shaft and handpiece defining a handle lumen;

a balloon catheter having a balloon received within the handle lumen and the balloon catheter having a proximal balloon displacer for manually displacing the balloon catheter relative to the handle lumen and a proximal luer adapter for attaching a fluid fill tube to inflate the balloon, wherein the balloon catheter has two primary positions relative to the handpiece comprising a retracted position wherein the balloon displacer is spaced from the handpiece and the balloon resides partly within the adapter of the handle shaft and an advanced position where the balloon displacer engages the handpiece and the balloon extends distally from the handle shaft adapter and is positioned within the expandable frame.

15. The system of claim 14, wherein the balloon displacer has a pair of small detents that engage similar cutouts on a proximal end of the handpiece to lock the balloon catheter in its advanced position.

16. The system of claim 14, further including a balloon extension wire that extends from a proximal end cap through an inflation tube and balloon and terminates in a molded balloon wire tip affixed to a distal end of the balloon, and a proximal end of the balloon affixes to the inflation tube, a proximal end of the balloon extension wire being spring-biased in a distal direction such that the balloon extension wire tends to elongate the balloon and facilitate deflation thereof.

17. The system of claim 14, wherein the balloon has a visible midline, that in a advanced position of the balloon, is located within 1-2 mm of the distalmost end of the expandable frame of the heart valve.

18. The system of claim 17, wherein the visible midline is formed by a small step molded in the balloon wall.

19. The system of claim 14, wherein the handle shaft is formed to be malleable so that it can be bent and retain its bent shape.

20. The system of claim 19, 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 close to an ID of the handle shaft lumen.

21. The system of claim 14, wherein the adapter of the handle shaft and proximal end of the valve holder have keyed structures that are unique for each different size of valve and integrated assembly such that a balloon catheter for one valve size cannot mate with a valve holder of a different valve size.

22. The system of claim 14, further including a locking clip that snaps onto the handpiece and a proximal end of the balloon catheter, the locking clip covering the luer adapter and preventing relative balloon catheter handpiece movement prior to removal.