Prosthetic heart valve and delivery apparatus

Patent metadata

Field	Value
Publication number	US-11730597-B2
Application number	US-202318102024-A
Country	US
Kind code	B2
Filing date	Jan 26, 2023
Priority date	Aug 22, 2008
Publication date	Aug 22, 2023
Grant date	Aug 22, 2023

Abstract

An assembly for replacement of a native aortic heart valve includes a radially collapsible prosthetic heart valve and a delivery apparatus. The prosthetic heart valve includes an annular frame with attachment posts, wherein each of the posts has an axial post portion and a transverse post portion having a greater circumferential dimension than the axial post portion. The delivery apparatus includes an inner shaft with a valve connection portion for releasably coupling to the attachment posts and an outer shaft having a sheath for maintaining the prosthetic heart valve in a radially compressed state. Rotation of a control knob on a handle causes the sheath to retract for uncovering a portion of the prosthetic heart valve. Further rotation of the control knob allows the posts to decouple from the delivery apparatus such that the prosthetic heart valve self-expands to a fully expanded state.

First claim

The invention claimed is:

1. An assembly for transvascular replacement of a native aortic heart valve, the assembly comprising:
a radially collapsible and self-expandable prosthetic heart valve comprising:
an annular frame made of a shape-memory material, the frame comprising a plurality of posts extending from a proximal end portion of the frame, wherein each of the posts comprises an axial post portion extending from the proximal end portion of the frame and a terminal post portion at the proximal end of the axial post portion, wherein the terminal post portion has a greater circumferential dimension than the axial post portion; and
a valve structure disposed within an interior of the frame; and

a delivery apparatus comprising:
an inner shaft comprising a valve connection portion that is releasably coupled to the posts of the prosthetic heart valve, wherein the valve connection portion comprises a plurality of discrete radially facing recesses, wherein each of the posts is positioned in a respective one of the recesses, wherein each of the recesses comprises an axial recess portion that receives the axial post portion of the respective post and an enlarged recess portion that receives the terminal post portion of the respective post, wherein each of the enlarged recess portions is defined by a curved wall formed in the valve connection portion, the curved wall extending partially around the corresponding terminal post portion, wherein for each of the recesses the enlarged recess portion has a circumferential dimension that is greater than the axial recess portion, and wherein the circumferential dimension of the terminal post portions is greater than the axial recess portions such that the posts cannot move axially out of the recesses;
an outer shaft positioned around the inner shaft, the outer shaft comprising a valve sheath at a distal end, the valve sheath being positioned around the prosthetic heart valve and the valve connection portion of the inner shaft, wherein the valve sheath maintains the prosthetic heart valve in a radially compressed state and maintains the posts within the recesses for delivery to a native aortic heart valve region; and
a handle comprising a housing, a screw shaft, a control knob that is rotatable relative to the housing and the screw shaft, and a screw engagement latch that is adjustable between an engaged position and a disengaged position, wherein in the engaged position the latch couples the control knob to the screw shaft such that rotation of the control knob relative to the housing causes the outer shaft to move axially relative to the housing, and in the disengaged position the latch decouples the control knob from the screw shaft such that the outer shaft can move axially relative to the housing without rotation of the control knob;

wherein when the latch is in the engaged position, rotation of the control knob in a first direction relative to the housing causes the valve sheath to move proximally relative to the prosthetic heart valve;
wherein rotation of the control knob in the first direction to a first position causes the valve sheath to uncover a distal majority of the prosthetic heart valve, while still covering the posts and maintaining the posts within the recesses, which allows the prosthetic heart valve to radially self-expand from the radially compressed state to a partially radially expanded state where the posts remain connected to the valve connection portion of the inner shaft; and
wherein further rotation of the control knob in the first direction from the first position to a second position causes the valve sheath to uncover the posts, which allows the prosthetic heart valve to radially self-expand from the partially radially expanded state to a fully radially expanded state, such that expansion of the prosthetic heart valve moves the posts radially out of the recesses, which releases the prosthetic heart valve from the delivery apparatus.

2. The assembly of claim 1 , wherein when the control knob is in the first position, a distal end of the valve sheath is positioned axially even with the proximal end portion of the frame.

3. The assembly of claim 1 , wherein rotation of the control knob from the first position in a second direction opposite the first direction causes the valve sheath to recover the distal portion of the prosthetic heart valve while maintaining the posts within the recesses, which causes the distal portion of the prosthetic heart valve to radially compress from the partially radially expanded state back to the radially compressed state.

4. The assembly of claim 1 , wherein the engaged position of the latch allows for micro control of axial motion of the valve sheath and the disengaged position of the latch allows for macro control of axial motion of the valve sheath.

5. The assembly of claim 1 , wherein the screw shaft comprises first threads and the screw engagement latch comprises at least one flange that engages with the first threads when the latch is in the engaged positioned such that rotating the control knob relative to the housing causes helical motion of the at least one latch flange relative to the first threads, which causes relative axial motion between the control knob and the screw shaft.

6. The assembly of claim 1 , wherein the handle further comprises a spring coupled to the latch, wherein the spring biases the latch toward the engaged position, wherein moving the latch to the disengaged position includes compressing the spring, and wherein moving the latch to the engaged position includes allowing the spring to expand.

7. The assembly of claim 1 , wherein the terminal post portions have an oval shape.

8. The assembly of claim 1 , wherein the terminal post portions are circumferentially curved and have a concave radially facing inner surface and a convex radially facing outer surface.

9. The assembly of claim 1 , wherein the terminal post portions each comprise an opening.

10. The assembly of claim 1 , wherein the plurality of posts consists of two posts and the plurality of discrete radially facing recesses consists of two discrete radially facing recesses.

11. An assembly for transvascular replacement of a native aortic heart valve, the assembly comprising:
a radially collapsible and self-expandable prosthetic heart valve comprising:
an annular frame made of a shape-memory material, the frame comprising a plurality of posts extending from a proximal end portion of the frame, wherein each of the posts comprises an axial post portion extending from the proximal end portion of the frame and a transverse post portion extending circumferentially from a proximal end of the axial post portion, wherein the transverse post portion has a greater circumferential dimension than the axial post portion, and wherein the transverse post portion is circumferentially curved and has a concave radially facing inner surface and a convex radially facing outer surface; and
a valve structure disposed within an interior of the frame; and

a delivery apparatus comprising:
an inner shaft comprising a valve connection portion that is releasably coupled to the posts of the prosthetic heart valve, wherein the valve connection portion comprises a plurality of radially facing recesses that receive the posts, wherein the recesses comprise circumferentially spaced apart axial recess portions that receive the axial post portions, wherein the circumferential dimension of the transverse post portions is greater than a circumferential dimension of the axial recess portions such that the posts cannot move axially out of the recesses;
an outer shaft positioned around the inner shaft, the outer shaft comprising a valve sheath at a distal end,

Assignees

• Edwards Lifesciences Corp

Inventors

• Alon David
• Benichou Netanel
• Meiri Oded

Classifications

• A61F2/2433

  using balloon catheter · CPC title

• A61F2/2436 Primary

  Deployment by retracting a sheath · CPC title

• A61F2/2418

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

• A61F2/2439

  Expansion controlled by filaments · CPC title

• A61F2/9517

  handle assemblies therefor · CPC title