Prosthetic heart valve delivery apparatus

Patent metadata

Field	Value
Publication number	US-10695176-B2
Application number	US-201815868741-A
Country	US
Kind code	B2
Filing date	Jan 11, 2018
Priority date	May 20, 2013
Publication date	Jun 30, 2020
Grant date	Jun 30, 2020

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.

First claim

We claim:

1. 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 coupled to the distal end portion of the second elongated shaft;
wherein the second shaft is configured to be rotatable relative to the first shaft without moving axially 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; and
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.

2. The apparatus of claim 1 , 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.

3. The apparatus of claim 2 , sized such that when the apparatus 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 delivery sheath is positioned in the ascending aorta, the screw is positioned in the descending aorta, and the proximal end portion of the delivery sheath extends through the aortic arch from the distal end portion of the delivery sheath to the nut.

4. The apparatus of claim 1 , wherein the proximal end portion of the delivery sheath is between about 2 cm and about 35 cm in length.

5. The apparatus of claim 1 , wherein the distal end portion of the first shaft extends through the delivery sheath and comprises a slotted metal tube.

6. The apparatus of claim 1 , 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.

7. The apparatus of claim 6 , 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.

8. The apparatus of claim 6 , wherein the at least one release member comprises a plurality of release members extending through the suture-retention member.

9. The apparatus of claim 6 , wherein the suture loops are formed from a single length of suture material.

10. The apparatus of claim 6 , wherein at least one of the suture loops has a greater thickness than others of the suture loops.

11. The apparatus of claim 1 , wherein the proximal end portion of the delivery sheath comprises a slotted metal tube.

12. The apparatus of claim 11 , 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.

13. The apparatus of claim 12 , wherein the delivery capsule comprises a polymer sleeve.

14. A medical assembly, comprising:
a delivery apparatus and a prosthetic valve;

wherein the delivery apparatus comprises:
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 coupled to the distal end portion of the second elongated shaft;
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;
wherein the prosthetic valve is located distal to the first shaft and comprises 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;
wherein:
the suture-retention member comprises a proximal portion and a distal portion spaced from the proximal portion, the proximal portion being coupled to the first shaft;
the at least one slidable release member extends through the proximal portion and the distal portion of the suture-retention member;
the plurality of suture loops extend 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 the suture-retention member, wherein at least one of the suture loops extends through the aperture of every apex; and
the delivery sheath can be advanced over the prosthetic valve to retain the prosthetic valve in the 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 delivery sheath, the delivery sheath can be advanced distally back over the prosthetic valve to cause the prosthetic valve to radially collapse as it is recaptured by the delivery sheath.

15. The apparatus medical assembly of claim 14 , 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 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.

Assignees

• Edwards Lifesciences Corp

Inventors

• Bakis George
• Nguyen Thanh V
• Phan Ly Th
• Metchik Asher L

Classifications

• A61F2/2439

  Expansion controlled by filaments · CPC title

• A61F2/2418

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2/2436 Primary

  Deployment by retracting a sheath · CPC title