PROSTHETIC HEART VALVE DELIVERY APPARATUS

• US 20150305867A1
• Filed: 07/08/2015
• Published: 10/29/2015
• Est. Priority Date: 02/25/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Liu, Jun, Metchik, Asher L.
• Granted Patent: US 10,561,494 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61M 25/0051 made from fenestrated or weakened tubing layer

Abstract

Certain embodiments of the present disclosure provide a prosthetic valve (e.g., prosthetic heart valve) and a valve delivery apparatus for delivery of the prosthetic valve to a native valve site via the human vasculature. The delivery apparatus is particularly suited for advancing a prosthetic heart valve through the aorta (i.e., in a retrograde approach) for replacing a diseased native aortic valve. The delivery apparatus in particular embodiments is configured to deploy a prosthetic valve from a delivery sheath in a precise and controlled manner at the target location within the body.

Claims

1. An assembly comprising:

a radially compressible and expandable prosthetic valve;

a storage tube containing the prosthetic valve; and

a delivery apparatus for the prosthetic valve, the delivery apparatus comprising a delivery sheath;

wherein the prosthetic valve is releasably secured to the delivery apparatus, the prosthetic valve being housed within the storage tube at a location distal to a distal end of the delivery sheath, the storage tube sized to retain the prosthetic valve in a partially compressed state, the delivery sheath configured to receive the partially compressed prosthetic valve from the storage tube and retain the prosthetic valve in a fully compressed state for delivery into a patient.

2. The assembly of claim 1, wherein the distal end of the delivery sheath extends into a proximal end portion of the storage tube.

3. The assembly of claim 1, further comprising a sterile package containing the prosthetic valve, the storage tube, and the delivery apparatus.

4. The assembly of claim 3, wherein the prosthetic valve comprises a frame and one or more leaflets supported by the frame, and the sterile package is free of any hydrating fluid for the leaflets.

5. The assembly of claim 1, wherein the delivery sheath has an inner diameter that is smaller than an inner diameter of the storage tube and the delivery sheath is configured to move distally relative to the prosthetic valve, wherein movement of the delivery sheath is effective to transfer the prosthetic valve from the storage tube into the delivery sheath and compresses the prosthetic valve from the partially compressed state to the fully compressed state.

6. The assembly of claim 5, wherein the storage tube comprises a storage section housing the prosthetic valve and a tapered section that has an inner diameter that decreases extending in a direction from the storage section toward the delivery sheath.

7. The assembly of claim 5, wherein the storage tube has an inner surface formed with an annular lip, and movement of the delivery sheath causes the distal end of the delivery sheath to bear against the annular lip, causing the prosthetic valve to be transferred from the storage tube into the delivery sheath.

8. The assembly of claim 5, wherein the delivery apparatus comprises a rotatable torque shaft, wherein rotation of the torque shaft is effective to produce movement of the delivery sheath relative to the prosthetic valve to transfer from the prosthetic valve from the storage tube into the delivery sheath.

9. The assembly of claim 1, wherein the delivery apparatus comprises a valve-retaining mechanism, and the prosthetic valve comprises a frame, the frame comprising a plurality of retaining arms releasably secured to the valve-retaining mechanism.

10. An assembly comprising:

a radially compressible and expandable prosthetic valve;

a storage tube containing the prosthetic valve; and

a delivery apparatus for the prosthetic valve, the delivery apparatus comprising a delivery sheath;

wherein the prosthetic valve is releasably secured to the delivery apparatus, the prosthetic valve being housed within the storage tube at a location distal to a distal end of the delivery sheath, the delivery sheath configured to receive the prosthetic valve from the storage tube and retain the prosthetic valve in a fully compressed state for delivery into a patient;

wherein the storage tube has an inner surface formed with an annular lip, the delivery sheath extends into the storage tube such that the distal end of the delivery sheath abuts the annular lip, and movement of the delivery sheath causes the distal end of the delivery sheath to bear against the annular lip, causing the prosthetic valve to be transferred from the storage tube into the delivery sheath.

11. The assembly of claim 10, further comprising a sterile package containing the prosthetic valve, the storage tube, and the delivery apparatus.

12. The assembly of claim 11, wherein the prosthetic valve is contained within the sterile package in a substantially dry state.

13. The assembly claim 11, wherein the prosthetic valve comprises a frame and one or more leaflets supported by the frame, and the sterile package is free of any hydrating fluid for the leaflets.

14. The assembly of claim 10, wherein the prosthetic valve is contained within the storage tube in a partially compressed state.

15. A method of loading a prosthetic valve into a delivery sheath of a delivery apparatus, the method comprising:

receiving a prosthetic valve pre-assembled within a storage tube in a sterile package, the storage tube retaining the prosthetic valve in a partially compressed state and the prosthetic valve being releasably secured to the delivery apparatus;

removing the storage tube and the prosthetic valve from the sterile package; and

transferring the prosthetic valve from the storage tube into the delivery sheath, wherein transferring the prosthetic valve into the delivery sheath radially compresses the prosthetic valve from the partially compressed state to a fully radially compressed state for transcatheter delivery into a patient.

16. The method of claim 15, wherein transferring the prosthetic valve from the storage tube into the delivery sheath comprises moving the delivery sheath distally over the prosthetic valve.

17. The method of claim 16, wherein movement of the delivery sheath is produced by rotating a torque shaft of the delivery apparatus.

18. The method of claim 17, wherein movement of the delivery sheath is produced by actuating a motor of the delivery apparatus, which rotates the torque shaft.

19. The method of claim 16, wherein moving the delivery sheath distally causes a distal end of the delivery sheath to bear against a lip of the storage tube to produce movement of the delivery sheath relative to the prosthetic valve to transfer from the prosthetic valve from the storage tube into the delivery sheath.