Prosthetic heart valve and delivery apparatus

• US 10,238,487 B2
• Filed: 06/13/2016
• Issued: 03/26/2019
• Est. Priority Date: 08/22/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Alon, David, Benichou, Netanel, Meiri, Oded
• Primary Examiner(s): McEvoy, Thomas M
• Application Number:
  US15/181,243
• Publication Number:
  US 20160287386A1
• Time in Patent Office: 1,016 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
• 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 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/005 using adhesives
• 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 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

Embodiments of the present disclosure provide a prosthetic heart valve and a heart valve delivery apparatus for delivery of the prosthetic heart valve to a native valve site via the human vasculature. The delivery apparatus is particularly suited for advancing a prosthetic valve through the aorta (i.e., in a retrograde approach) for replacing a diseased native aortic valve. In one embodiment, a self-expanding valve comprises an expandable stent that is shaped to maintain the valve in the aortic annulus against axial without anchors or retaining devices that engage the surrounding tissue. A delivery apparatus for delivering s self-expanding prosthetic valve can be configured to allow controlled and precise deployment of the valve from a valve sheath so as to minimize or prevent jumping of the valve from the valve sheath.

Claims

1. A system for replacing a native heart valve, comprising:

a collapsible and expandable prosthetic heart valve comprising a frame and a valve member having a plurality of flexible leaflets configured for allowing blood flow in only one direction, wherein the valve member is mounted within the frame; and

a delivery apparatus comprising;

a handle portion;

a sheath sized to extend over and retain the prosthetic heart valve in a compressed state;

a shaft having a proximal end portion and a distal end portion, wherein the proximal end portion of the shaft is coupled to the handle portion;

a tube positioned radially outside the shaft and radially inside the sheath, when the sheath is over the prosthetic heart valve;

at least one suture member secured to and extending from the tube and forming a loop; and

a release wire radially outside of the shaft that extends through and is movable axially within a lumen of the tube;

wherein the at least one suture member extends through an end portion of the frame of the prosthetic heart valve, and wherein, as viewed in a proximal to distal direction, a portion of the release wire extends from the tube, through the loop of the at least one suture member, and then through a spacer positioned radially outside the shaft with the portion of the release wire extending through the loop of the at least one suture member at a location axially between the tube and the spacer, to releasably secure the suture member relative to the prosthetic heart valve, and wherein the release wire is axially movable to remove the portion of the release wire from the spacer and the loop to thereby release the suture member from the prosthetic heart valve.

2. The system of claim 1, wherein the distal end portion of the shaft includes a nose piece secured thereto, wherein the nose piece includes a first outer diameter large enough to close the distal opening of the sheath and gradually tapers in a distal direction from the first outer diameter to a second outer diameter smaller than the first outer diameter.

3. The system of claim 1, wherein the at least one suture member extends in a distal direction from the tube and through a proximal end portion of the frame of the prosthetic heart valve.

4. The system of claim 1, wherein the delivery apparatus further comprises an adjustment control that is operable to cause bending or flexing at a distal end of the delivery apparatus.

5. The system of claim 4, wherein the adjustment control comprises a knob rotatable by a user to cause a pull wire to move and thereby increase or decrease the bending or flexing at the distal end of the delivery apparatus.

6. The system of claim 1, wherein the release wire removably extends through a lumen of the spacer to maintain the release wire in a parallel alignment with the shaft when the suture member is secured relative to the prosthetic heart valve.

7. The system of claim 1, wherein the release wire is axially movable from a first position to a second position, wherein the release wire extends through the lumen of the tube, extends through the loop of the at least one suture member, and extends through the spacer when the second shaft is in the first position, and wherein the release wire is withdrawn from the spacer and the loop of the suture member when the release wire is in the second position.

8. The system of claim 7, wherein the release wire extends through the loop of the suture member at a location distal to where the at least one suture is secured to the tube and proximal to the spacer.

9. The system of claim 1, wherein the delivery apparatus is configured such that, when the suture member is secured relative to the prosthetic heart valve and the sheath is retracted from over the prosthetic heart valve, a position of the prosthetic heart valve within the native heart valve can be adjusted by moving the handle portion.

10. The system of claim 1, wherein the frame of the prosthetic heart valve comprises an aperture formed in the end portion, and the at least one suture member extends through the aperture of the frame.

11. The system of claim 1, wherein the frame of the prosthetic heart valve comprises a plurality of apertures formed in the end portion, and the suture member comprises a plurality of suture members, and wherein the suture members extend through respective apertures of the frame.

12. The system of claim 1, wherein the delivery apparatus further comprises a plurality of flexible flaps configured to extend over and radially collapse the end portion of the prosthetic heart valve from an expanded configuration to a compressed configuration such that the prosthetic heart valve is retractable into the sheath of the delivery apparatus.

13. The system of claim 1, wherein the prosthetic heart valve is self-expandable.

14. A delivery apparatus, comprising:

an expandable prosthetic heart valve comprising a frame and a valve member having a plurality of flexible leaflets;

a handle portion;

a sheath configured to extend over and retain a self-expandable prosthetic heart valve in a compressed state;

a shaft having a proximal end portion and a distal end portion, wherein the proximal end portion of the shaft is coupled to the handle portion;

a tubular member positioned radially outside the shaft;

at least one suture member secured to and extending from the tubular member proximate the distal end portion of the shaft and forming a loop; and

a release wire radially outside of the shaft that extends through and is movable axially within a lumen of the tubular member;

wherein the at least one suture member can extend through a portion of the prosthetic heart valve, wherein a spacer is positioned radially outside the shaft, and wherein a portion of the release wire is axially movable from a first position to a second position, wherein as viewed in a proximal to distal direction, the portion of the release wire extending from the tubular member, through the loop of the at least one suture member, and then through the spacer in the first position to releasably secure the suture member relative to the prosthetic heart valve, and the portion of the release wire withdrawn from the spacer and the loop of the at least one suture member in the second position, thereby releasing the suture member from the prosthetic heart valve.

15. The apparatus of claim 14, wherein the at least one suture member extends in a distal direction from the tubular member and through a proximal end portion of the prosthetic heart valve.

16. The apparatus of claim 14, wherein the delivery apparatus further comprises an adjustment control that is operable to cause a pull wire to move and thereby increase or decrease the bending or flexing at the distal end of the delivery apparatus.

17. The apparatus of claim 14, wherein the release wire removably extends through a lumen of the spacer to maintain the release wire in a parallel alignment with the shaft when the suture member is secured relative to the prosthetic heart valve.

18. The apparatus of claim 17, wherein the release wire extends through the loop of the suture member at a location distal to where the at least one suture is secured to the tube and proximal to the spacer.

19. A system for replacing a native heart valve, comprising:

a prosthetic heart valve self-expandable from a low-profile collapsed configuration to an expanded configuration, wherein the prosthetic heart valve comprises a frame and a valve member having a plurality of flexible leaflets configured for allowing blood flow in only one direction, wherein the valve member is mounted to the frame; and

a delivery apparatus comprising;

a handle portion;

a sheath sized to extend over and retain the prosthetic heart valve in a compressed state;

a shaft having a proximal end portion and a distal end portion, wherein the proximal end portion of the shaft is coupled to the handle portion and the distal end portion is coupled to a nose piece that includes a gradual taper from a larger diameter to a smaller diameter;

a tube positioned radially outside the shaft proximate the distal end portion of the shaft;

at least one suture member secured to and extending from the tube and comprising a loop; and

a release wire radially outside of the shaft that extends through and is movable axially within a lumen of the tube;

wherein the release wire is axially movable from a first position to a second position, wherein, in the first position, the release wire extends through the lumen of the tube, then extends through the loop of the at least one suture member, as viewed in a proximal to distal direction, the at least one suture member extending through a proximal end portion of the frame of the prosthetic heart valve, and then extends through a spacer, and wherein, in the second position, the release wire is withdrawn from the spacer and the loop of the at least one suture member, thereby releasing the suture member from the prosthetic heart valve.