Prosthetic heart valve delivery apparatus

• US 9,867,700 B2
• Filed: 05/20/2014
• Issued: 01/16/2018
• 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., Metchik, Asher L.
• Primary Examiner(s): Rodjom, Katherine
• Application Number:
  US14/283,056
• Publication Number:
  US 20140343670A1
• Time in Patent Office: 1,337 Days
• 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;

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, a distal portion spaced from the proximal portion, and an intermediate shaft portion extending between and fixedly connected to the proximal portion and to the distal portion, the proximal portion being fixedly 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, around the apices of the stent or through apertures in the apices of the stent, and around the at least one release member at a location between the proximal and distal portions of the suture-retention member, wherein at least one suture loops extends around every apex or through an 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 outer sheath, the outer sheath can be advanced distally back over the prosthetic valve to cause the prosthetic valve to radially collapse as it is recaptured by the outer 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 at least one release member is retracted proximally such that a distal end of the at least one release member is proximal to the distal portion of the suture-retention member, the suture loops can slide off the distal end of the at least one 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 outer sheath is at least about 5 cm in length and no greater than about 40 cm in length.

9. The assembly of claim 1, wherein after the entirety of the prosthetic valve is deployed from the sheath, distal advancement of the outer sheath creates tension in each of the suture loops, thereby causing each of the apices to collapse radially inward toward the shaft.

10. The assembly of claim 1, wherein each of the apices bears against a distal surface of the distal portion when the outer sheath is retracted proximally relative to the suture-retention member.

11. The assembly of claim 1, wherein the plurality of suture loops are threaded sequentially around each apex or through the aperture of each apex in a circumferential direction around the stent.

12. The assembly of claim 1, wherein the plurality of suture loops are threaded non-sequentially around each apex or through the aperture of each apex in a circumferential direction around the stent multiple times.

13. The assembly of claim 1, wherein the shaft comprises a first shaft and the assembly further comprises a second shaft extending co-axially through the first shaft and the suture-retention member, and a nose cone is mounted on a distal end portion of the second shaft distal to the suture-retention member.

14. The assembly of claim 13, wherein the outer sheath comprises a reinforced distal tip portion or a metal cylinder having a polymeric soft tip portion fixedly coupled to a distal end portion of the cylinder.

15. 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, the second shaft being rotatable relative to the first shaft but fixed against axial movement relative to the first shaft;

wherein the outer sheath has a distal end portion configured to receive and retain the prosthetic valve in the radially compressed state, and a proximal end portion connected to a distal end portion of the second shaft;

wherein the proximal end portion of the outer sheath is more flexible than the distal end portion of the outer sheath, wherein the outer sheath is at least about 5 cm in length and no greater than about 40 cm in length;

wherein the rotation of the second shaft causes the outer sheath to move axially relative to the first and second shafts.

16. The assembly of claim 15 further comprising a screw connected to a distal end of the second shaft, and a nut mounted on the screw and connected to the outer 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 outer sheath.

17. The assembly of claim 16 is sized such that when the assembly is advanced through the aorta and the prosthetic valve is positioned at the native aortic valve of a patient, the distal end portion of the outer sheath is positioned in the ascending aorta, the screw is positioned in the descending aorta, and the proximal portion of the outer sheath extends through the aortic arch from the distal end portion of the outer sheath to the nut.

18. The assembly of claim 1, wherein a distal end portion of the outer sheath comprises a radially projecting, annular bump.

19. 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;

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, around the apices of the stent or through apertures in the apices of the stent, and around the at least one release member at a location between the proximal and distal portions of the suture-retention member, wherein at least one suture loop extends around every apex or through an 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 outer sheath, the outer sheath can be advanced distally back over the prosthetic valve to cause the prosthetic valve to radially collapse as it is recaptured by the outer sheath;

wherein at least one of the suture loops has a greater thickness than others of the suture loops.

20. 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;

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

a second 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;

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 shaft, wherein the proximal end portion of the delivery sheath is more flexible than the distal end portion of the delivery sheath, 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;

a suture-retention member having a proximal portion, a distal portion spaced from the proximal portion, and an intermediate shaft portion extending between and fixedly connected to the proximal portion and to the distal portion, the proximal portion being fixedly coupled to the distal end portion of the first shaft;

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

a plurality of suture loops extending from the proximal portion of the suture-retention member, around the apices of the stent or through apertures in the apices of the stent, and around the release member at a location along the intermediate shaft portion, wherein at least one suture loop extends around every apex or through an aperture of every apex.

21. The assembly of claim 20, 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.

22. The assembly of claim 20, wherein the proximal end portion of the delivery sheath is between about 2 cm and about 35 cm in length.

23. The assembly of claim 20, wherein the distal end portion of the first shaft extends through the delivery sheath and comprises a slotted metal tube.

24. The assembly of claim 20, wherein:

the at least one 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 at least one release member is retracted to a location proximal of the distal portion of the suture-retention member;

wherein when the at least one release member is in the first position and the suture loops extend around the apices or through the apertures of the stent and around the at least one release member at a location between the proximal and distal portions, the prosthetic valve is secured to the suture-retention member;

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

25. The assembly of claim 20, wherein the at least one release member comprises a plurality of release members extending through the suture-retention member.

26. The assembly of claim 20, wherein the proximal end portion of the delivery sheath comprises a slotted metal tube.

27. The assembly of claim 26, wherein the distal end portion of the delivery 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.

28. The assembly of claim 27, wherein the delivery capsule comprises a polymer sleeve.