PROSTHETIC HEART VALVE DELIVERY APPARATUS

• US 20140343670A1
• Filed: 05/20/2014
• Published: 11/20/2014
• Est. Priority Date: 05/20/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Bakis, George, Nguyen, Thanh V., Phan, Ly T.
• Granted Patent: US 9,867,700 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments

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. A prosthetic valve delivery assembly, comprising:

a prosthetic valve comprising a self-expandable stent having a plurality of apices spaced circumferentially around a first end portion of the stent, wherein each apex has an aperture;

an elongate shaft located proximal to the prosthetic valve;

a suture-retention member located distal to the shaft, the suture-retention member comprising a proximal portion and a distal portion spaced from the proximal portion, the proximal portion being coupled to the shaft;

at least one slidable release member extending through the proximal portion and the distal portion of the suture-retention member;

a plurality of suture loops extending from the proximal portion of the suture-retention member, through the apertures in the apices of the stent, and around the release member at a location between the proximal and distal portions of suture-retention member, wherein at least one of the suture loops extends through the aperture of every apex; and

an outer sheath which can be advanced over the prosthetic valve to retain the prosthetic valve in a radially compressed state and retracted relative to the prosthetic valve to permit radial expansion of the prosthetic valve, while the stent remains connected to the suture-retention member via the suture loops;

wherein after the entirety of the prosthetic valve is deployed from the sheath, the sheath can be advanced distally back over the prosthetic valve to cause the prosthetic valve to radially collapse as it is recaptured by the sheath.

2. The assembly of claim 1, wherein the suture loops are formed from a single length of suture material.

3. The assembly of claim 1, wherein the shaft comprises a first shaft and the assembly further comprises a second shaft extending at least partially through the first shaft, wherein the outer sheath can be advanced or retracted relative to the prosthetic valve by rotating the second shaft relative to the first shaft.

4. The assembly of claim 1, wherein the at least one release member is slidable relative to the suture-retention member, and when the release member is retracted proximally such that a distal end of the release member is proximal to the distal portion of the suture-retention member, the suture loops can slide off the distal end of the release member, thereby releasing the prosthetic valve from the suture-retention member.

5. The assembly of claim 1, wherein at least a portion of the outer sheath comprises a slotted metal tube.

6. The assembly of claim 5, wherein a distal end portion of the outer sheath comprises a delivery capsule connected to a distal end of the slotted metal tube, the delivery capsule configured to extend over and retain the prosthetic valve in the radially compressed state.

7. The assembly of claim 6, wherein the delivery capsule comprises a polymer sleeve.

8. The assembly of claim 1, wherein the sheath is at least about 5 cm is length and no greater than about 40 cm in length.

9. The assembly of claim 1, wherein at least one of the suture loops has a greater thickness than others of the suture loops.

10. A delivery apparatus for implanting a prosthetic valve, comprising:

a first elongated shaft having a proximal end portion and a distal end portion;

a second elongated shaft extending through the first shaft and having a proximal end portion and a distal end portion, the second shaft being rotatable relative to the first shaft but fixed against axial movement relative to the first shaft; and

a delivery sheath having a distal end portion configured to receive and retain a prosthetic valve in a compressed delivery state, and a proximal end portion connected to the distal end portion of the second elongated shaft, wherein the proximal end portion is more flexible than the distal end portion, wherein the delivery sheath is at least about 5 cm in length and no greater than about 40 cm in length;

wherein the second shaft is configured to be rotatable relative to the first shaft such that rotation of the second shaft causes the delivery sheath to move axially relative to the first and second shafts.

11. The apparatus of claim 10, further comprising a screw connected to a distal end of the second shaft, and a nut mounted on the screw and connected to the delivery sheath such that rotation of the second shaft and the screw causes axial movement of the nut relative to the screw, thereby producing axial movement of the delivery sheath.

12. The apparatus of claim 10, wherein the proximal end portion of the delivery sheath is between about 2 cm and about 35 cm in length.

13. The apparatus of claim 10, wherein the distal end portion of the first shaft extends through the delivery sheath and comprises a slotted metal tube.

14. The apparatus of claim 10, further comprising:

a suture-retention member connected to the distal end portion of the first shaft;

a plurality of suture loops extending from the suture-retention member and configured to extend through openings in a frame of the prosthetic valve; and

at least one slidable release member configured to extend through the suture-retention member and the suture loops to releasably secure the prosthetic valve to the suture-retention member.

15. The apparatus of claim 14, wherein:

the suture-retention member comprises a proximal portion and a distal portion spaced axially apart from the first portion;

the release member is slidable relative to the suture-retention member between a first position extending through the proximal and distal portions of the suture-retention member and a second position in which the release member is retracted to a location proximal of the distal portion of the suture-retention member;

wherein when the release member is in the first position and the suture loops extend through the openings of the frame and around the release member at a location between the proximal and distal portions, the prosthetic valve is secured to the suture-retention member;

wherein when the release member is in the second position, the suture loops can slide off a distal end of the release member to release the prosthetic valve from the suture-retention member.

16. The apparatus of claim 14, wherein the at least one release member comprises a plurality of release members extending through the suture-retention member.

17. The apparatus of claim 10, wherein the proximal end portion of the outer sheath comprises a slotted metal tube.

18. The apparatus of claim 17, wherein the distal end portion of the outer sheath comprises a delivery capsule connected to a distal end of the slotted metal tube, the delivery capsule configured to extend over and retain the prosthetic valve in the compressed delivery state.

19. The apparatus of claim 18, wherein the delivery capsule comprises a polymer sleeve.

20. A method for delivering a prosthetic valve to the aortic annulus of the heart, the method comprising:

inserting an elongated delivery apparatus into a femoral artery of a patient, the delivery apparatus comprising a delivery sheath containing the prosthetic valve in a radially compressed state;

advancing the delivery apparatus through the aorta until the prosthetic valve is at an implantation location within the aortic annulus, wherein when the prosthetic valve is at the implantation location, the delivery sheath extends through the ascending aorta and the aortic arch and a proximal end of the delivery sheath is within the descending aorta; and

retracting the delivery sheath relative to the prosthetic valve to deploy the prosthetic valve from a distal end of the delivery sheath.

21. The method of claim 20, wherein the delivery sheath is between about 5 cm and about 40 cm in length.

22. The method of claim 20, wherein the delivery sheath comprises a distal end portion and a proximal end portion that is more flexible than the distal end portion, the distal end portion extending over and retaining the prosthetic valve in the radially compressed state during the acts of the inserting and advancing the delivery apparatus, the proximal end portion extending through the ascending aorta, the aortic arch and into the descending aorta when the prosthetic valve is at the implantation location.

23. The method of claim 20, wherein the prosthetic valve is releasably secured to the delivery apparatus via a plural of suture loops.

24. The method of claim 23, wherein the act of retracting the delivery sheath comprises deploying the entire prosthetic valve from the delivery sheath, allowing the prosthetic valve to radially expand while still secured to the delivery apparatus via the suture loops.

25. The method of claim 24, wherein after deploying the entire prosthetic valve from the delivery sheath, recapturing the prosthetic valve by advancing the delivery sheath distally back over the prosthetic valve.

26. A method for delivering a prosthetic valve to a native valve annulus of the heart, the method comprising:

inserting an elongated delivery apparatus into the vasculature of a patient, the delivery apparatus comprising a delivery sheath containing the prosthetic valve in a radially compressed state, wherein the prosthetic valve is releasably secured to the delivery apparatus via a plural of suture loops;

retracting the delivery sheath relative to the prosthetic valve to deploy the entire prosthetic valve from the delivery sheath, allowing the prosthetic valve to radially expand while still secured to the delivery apparatus via the suture loops; and

wherein after deploying the entire prosthetic valve from the delivery sheath, recapturing the prosthetic valve by advancing the delivery sheath distally back over the prosthetic valve.