Prosthetic heart valve delivery apparatus
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.
1. An assembly comprising:
a radially compressible and expandable prosthetic valve, the prosthetic valve comprising a frame and one or more leaflets, the frame being self-expandable from a radially collapsed state to a radially expanded state;
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 retaining the prosthetic valve in a partially compressed state between the radially collapsed state and the radially expanded state along the entire length of the prosthetic valve thereby preventing the prosthetic valve from self-expanding to the radially expanded 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 assembly is free of any hydrating fluid in contact with the one or more 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 a proximal end and an inner surface formed with an annular lip spaced distally from the proximal end, and movement of the delivery sheath causes the distal end of the delivery sheath to move into the storage tube and 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 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. The assembly of claim 1 , wherein the prosthetic valve comprises a stent having a first end and a second end, opposite the first end, and a plurality of struts arranged in rows and connected to each other so as to form a plurality of first apexes pointing toward the first end of the stent and a plurality of second apexes pointing toward the second end of the stent, wherein each of the first apexes are fixed apexes formed by two adjacent struts in the same row of struts and at least one additional strut in an adjacent row of struts, and wherein the stent comprises fewer first apexes than second apexes.
11. 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 having a distal end portion comprising a terminal distal-most end;
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 portion 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 a proximal end and an inner surface formed with an annular lip spaced distally from the proximal end, the delivery sheath extends into the storage tube such that the terminal distal-most end of the delivery sheath abuts the annular lip, and movement of the delivery sheath causes the terminal distal-most 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.
12. The assembly of claim 11 , further comprising a sterile package containing the prosthetic valve, the storage tube, and the delivery apparatus.
13. The assembly of claim 12 , wherein all of the prosthetic valve is contained within the sterile package and wherein the assembly does not include a hydrating fluid in contact with leaflets of the prosthetic valve.
14. The assembly claim 12 , wherein the prosthetic valve comprises a frame and one or more leaflets supported by the frame, and the prosthetic valve is stored within the sterile package without any hydrating fluid in contact with the leaflets.
15. The assembly of claim 11 , wherein the prosthetic valve is contained within the storage tube in a partially compressed state.
16. A method of loading a prosthetic valve into a delivery sheath of a delivery apparatus, the method comprising:
obtaining a sterile package that encloses a storage tube retaining an annular frame and leaflets of a prosthetic valve in a partially compressed state and the prosthetic valve being releasably secured to the delivery apparatus; 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, and wherein transferring the prosthetic valve into the delivery sheath comprises moving the delivery sheath distally into the storage tube such that a distal end of the delivery sheath bears against an annular lip formed on an inner surface of the storage tube to produce movement of the delivery sheath relative to the prosthetic valve to transfer the prosthetic valve from the storage tube into the delivery sheath.
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 17 , wherein movement of the delivery shaft is produced by manually turning a rotatable component coupled to the torque shaft.
20. The method of claim 19 , wherein the rotatable component is coupled to the torque shaft with one or more gears.