US-12616571-B2 - Implantable frame and frame retaining mechanism

Abstract

Embodiments of an implantable frame are disclosed. The frame can have a plurality of struts interconnected to each other to form a mesh structure that is radially expandable and compressible. The frame can have a connecting post extending from an end of the frame. The connecting post can have a body portion and a head portion affixed to an end of the body portion. The head portion can have a first edge extending outwardly of the body portion. The first edge can have a substantially flat portion that is substantially perpendicular to the body portion.

Inventors

• Eran Goldberg

Assignees

• EDWARDS LIFESCIENCES CORPORATION

Dates

Publication Date

20260505

Application Date

20230217

Claims (20)

1. 1 . An implantable frame comprising: a plurality of struts interconnected to each other to form a mesh structure, the mesh structure being radially expandable and compressible; and a connecting post extending from an end of the mesh structure, the connecting post comprising a body portion and a head portion affixed to an end of the body portion; wherein the head portion has a first edge extending outwardly of the body portion, wherein the first edge comprises a substantially flat portion that is substantially perpendicular to the body portion, wherein the first edge of the head portion has a recessed portion connecting between the substantially flat portion of the first edge and the end of the body portion, wherein the recessed portion of the first edge extends inwardly into the head portion.
2. 2 . The frame of claim 1 , wherein the plurality of struts comprises a self-expandable material.
3. 3 . The frame of claim 1 , wherein the head portion has a wedge shape which tapers from the first edge to a second edge of the head portion, the second edge being farther away from the body portion relative to the first edge.
4. 4 . The frame of claim 3 , wherein the head portion of the connecting post has a curved side connecting the first edge and the second edge, the curved side bulging outwardly relative to the first and second edges.
5. 5 . The frame of claim 1 , wherein the first edge is divided by the body portion into two halves.
6. 6 . The frame of claim 5 , wherein both the two halves of the first edge are symmetric about the body portion.
7. 7 . The frame of claim 1 , wherein the head portion of the connecting post has a first surface configured to interface with a floor of a recess located on a retainer, wherein the first surface and the floor are substantially flat.
8. 8 . The frame of claim 7 , wherein the head portion of the connecting post has a second surface opposite the first surface, the second surface being substantially flat, wherein the first and second surfaces define a thickness of the head portion of the connecting post, the thickness being equal to or smaller than a depth of the recess.
9. 9 . The frame of claim 1 , wherein a length of the substantially flat portion of the first edge is a predefined percentage of a width of the head portion.
10. 10 . The frame of claim 9 , wherein a length of the substantially flat portion of the first edge and a width of the body portion has a predefined ratio.
11. 11 . The frame of claim 1 , wherein the connecting post is one of a plurality of connecting posts that are circumferentially disposed at the end of the frame.
12. 12 . The frame of claim 11 , wherein the plurality of connecting posts are spaced apart from each other uniformly at the end of the frame.
13. 13 . The frame of claim 1 , wherein the end of the frame is a proximal end of the frame.
14. 14 . An assembly comprising: a radially expandable and compressible frame comprising a plurality of struts interconnected to each other to form a mesh structure and a connecting post extending from an end of the mesh structure; and a delivery device comprising a retainer configured to be releasably connected to the connecting post; wherein the connecting post comprises a body portion and a head portion affixed to an end of the body portion; wherein the head portion has a first edge extending outwardly of the body portion, wherein the first edge comprises a substantially flat portion that is substantially perpendicular to the body portion, wherein the retainer comprises a post connector region, wherein the post connector region comprises a recess configured to receive the head portion of the connecting post, wherein the recess comprises a first end wall, a second wall, and a floor having two side edges extending axially from the first end wall to the second end wall, wherein the head portion has a maximum width measured in a direction perpendicular to a length of the connecting post and the floor has a width extending from one side edge of the floor to the other side edge of the floor, wherein the width of the floor is greater than the maximum width of the head portion, and the head portion is spaced from the side edges of the floor along an axis that is perpendicular to the length of the connecting post when the head portion is disposed in the recess.
15. 15 . The assembly of claim 14 , wherein the post connector region further comprises a slot connected to the recess, wherein the slot is configured to receive at least an end portion of the body portion of the connecting post.
16. 16 . The assembly of claim 14 , wherein the retainer comprises a central lumen.
17. 17 . The assembly of claim 14 , wherein the connecting post is one of a plurality of connecting posts that are circumferentially disposed at the end of the frame, wherein the plurality of connecting posts are configured to be releasably connected to respective post connector regions of the retainer.
18. 18 . The assembly of claim 14 , wherein the delivery device comprises an outer sheath configured to retain the frame in a compressed state inside a lumen of the outer sheath, wherein the connecting post of the frame is connected to the retainer that is retained inside the lumen.
19. 19 . An assembly comprising: a radially expandable and compressible frame comprising a plurality of struts interconnected to each other to form a mesh structure and a connecting post coupled to the frame; and a delivery catheter configured to deliver the frame to a target implantation site, the delivery catheter comprising a retainer configured to be releasably connected to the connecting post; wherein the connecting post and the retainer are configured to form a contacting interface that is substantially perpendicular to an axial axis of the delivery catheter when the connecting post is connected to the retainer, wherein the retainer comprises a recess configured to receive a head portion of the connecting post, wherein the recess comprises a rectangular, flat floor having two axially extending side edges that intersect a cylindrical outer surface of the retainer.
20. 20 . The assembly of claim 14 , wherein the floor is flat and the side edges of the floor of the recess intersect a cylindrical outer surface of the retainer.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of PCT Patent Application No. PCT/US2021/046204, filed Aug. 17, 2021, which claims the benefit of both U.S. Provisional Application No. 63/066,688, filed Aug. 17, 2020, and U.S. Provisional Application No. 63/194,131, filed May 27, 2021, each of which is incorporated herein by reference. FIELD The present disclosure concerns embodiments of a frame for implantation into body ducts and related frame retaining mechanism for facilitating implantation of the frame, as well as embodiments of a delivery apparatus for transcatheter valve implantation. BACKGROUND Prosthetic heart valves can be used to treat cardiac valvular disorders. The native heart valves (the aortic, pulmonary, tricuspid and mitral valves) function to prevent backward flow or regurgitation, while allowing forward flow. These heart valves can be rendered less effective by congenital, inflammatory, infectious conditions, etc. Such conditions can eventually lead to serious cardiovascular compromise or death. For many years, the doctors attempted to treat such disorders with surgical repair or replacement of the valve during open heart surgery. A transcatheter technique for introducing and implanting a prosthetic heart valve using a catheter in a manner that is less invasive than open heart surgery can reduce complications associated with open heart surgery. In this technique, a prosthetic valve can be mounted in a compressed state on the end portion of a catheter and advanced through a blood vessel of the patient until the valve reaches the implantation site. The valve at the catheter tip can then be expanded to its functional size at the site of the defective native valve, such as by inflating a balloon on which the valve is mounted or, for example, the valve can have a resilient, self-expanding stent or frame that expands the valve to its functional size when it is advanced from a delivery sheath at the distal end of the catheter. Optionally, the valve can have a balloon-expandable, self-expanding, mechanically expandable frame, and/or a frame expandable in multiple or a combination of ways. Transcatheter heart valves (THVs) may be appropriately sized to be placed inside many native aortic valves. However, with larger native valves, blood vessels (e.g., an enlarged aorta), grafts, etc., aortic transcatheter valves might be too small to secure into the larger implantation or deployment site. In this case, the transcatheter valve may not be large enough to sufficiently expand inside the native valve or other implantation or deployment site. Also, the implantation or deployment site may not provide a good seat for the THV to be secured in place. As one example, aortic insufficiency can be associated with difficulty securely implanting a THV in the aorta and/or aortic valve. Accordingly, improvements to the THVs and the associated transcatheter delivery apparatus are desirable. SUMMARY This summary is meant to provide examples and is not intended to limit the scope of the invention in any way. Generally, the present disclosure is directed toward methods and apparatuses relating to implanting a stent frame into a target implantation site via a patient's vasculature. As described more fully below, the stent frame can be a part of a prosthetic valve, a part of a docking station or docking device configured to receive a prosthetic valve, part of stent graft or other implantable devices. Certain embodiments of the disclosure concern an implantable frame. The frame can include a plurality of struts interconnected to each other to form a mesh structure. The mesh structure can be radially expandable and compressible. The frame can also include a connecting post extending from an end of the mesh structure. The connecting post can include a body portion and a head portion affixed to an end of the body portion. The head portion can have a first edge extending outwardly of the body portion. The first edge can include a substantially flat portion that is substantially perpendicular to the body portion. Certain embodiments of the disclosure also concern an assembly. The assembly can include a radially expandable and compressible frame having a plurality of struts interconnected to each other to form a mesh structure and a connecting post extending from an end of the mesh structure. The assembly can also include a delivery device having a retainer configured to be releasably connected to the connecting post. The connecting post can include body portion and a head portion affixed to an end of the body portion. The head portion can have a first edge extending outwardly of the body portion. The first edge can include a substantially flat portion that is substantially perpendicular to the body portion. Certain embodiments of the disclosure also concern an assembly including a radially expandable and compressible frame and a delivery catheter configured to deliver the frame to a target implantati