Crimping accessory device for a prosthetic valve

Patent metadata

Field	Value
Publication number	US-2021228343-A1
Application number	US-202117228446-A
Country	US
Kind code	A1
Filing date	Apr 12, 2021
Priority date	Nov 17, 2016
Publication date	Jul 29, 2021
Grant date	—

Abstract

Embodiments are provided of an assembly having a prosthetic valve, the prosthetic valve having a radially expandable and compressible annular frame, and a crimping accessory device, and methods for using the assembly in compressing the prosthetic valve. The frame includes an outer surface and an inner surface. A leaflet assembly is supported inside the annular frame. The leaflet assembly includes a plurality of leaflets, each having an inner surface and an outer surface. The crimping accessory device has a plurality of axially-extending fingers. At least a first finger of the plurality of fingers is disposed between the outer surface of a first leaflet of the plurality of leaflets, and at least a second finger of the plurality of fingers is disposed radially-inwardly of the inner surface of the first leaflet.

First claim

We claim:

1 . An assembly comprising:
a prosthetic valve comprising a radially expandable and compressible annular frame, the annual frame having an outer surface and an inner surface, and a leaflet assembly supported inside the annular frame, the leaflet assembly comprising a plurality of leaflets, each leaflet of the plurality of leaflets having an inner surface and an outer surface; and a crimping accessory device comprising a shaft and at least one axially-extending finger fixedly secured to an end of the shaft and disposed between the inner surface of the frame and an outer surface of a first leaflet of the plurality of leaflets, the at least one axially-extending finger comprising a hook formed on an outer surface of the axially-extending finger at a location spaced apart proximally from a distal end of the axially-extending finger, at least a portion of the hook extending about the outer surface of the frame.

2 . The assembly of claim 1 , wherein the hook engages a portion of the annular frame.

3 . The assembly of claim 2 , wherein the portion of the annular frame is received by an aperture defined by a radially-inner surface of a portion of the hook spaced apart from an outer radial surface of the shaft.

4 . The assembly of claim 3 , the portion of the hook extending longitudinally, distally, and parallel to, an outer surface of the shaft.

5 . The assembly of claim 3 , wherein the aperture is not accessible from a proximal, longitudinal side of the hook.

6 . The assembly of claim 1 , wherein the crimping accessory device comprises a plurality of axially-extending fingers fixedly secured to the end of the shaft, the plurality of axially-extending fingers comprising the at least one axially-extending finger, which is a first finger of the plurality of axially-extending fingers, wherein a second leaflet of the plurality of leaflets is disposed between an outer surface of a second finger of the plurality of axially-extending fingers and an inner surface of the frame.

7 . The assembly of claim 6 , wherein the second finger is formed from a resilient material, and the second finger is deflected radially-inwardly and exerts a radially-outwardly directed force against the inner surface of the second leaflet.

8 . The assembly of claim 6 , the plurality of leaflets defining a plurality of leaflet commissures connected to the annular frame, wherein the plurality of leaflets are joined at respective commissures and a finger of the plurality of axially-extending fingers is disposed proximate each side of the respective commissure.

9 . An assembly comprising:
a prosthetic valve comprising a radially expandable and compressible annular frame, the annular frame having an outer surface, an inner surface, and struts defining a plurality of frame windows, the prosthetic valve further comprising a leaflet assembly supported inside the annular frame, the leaflet assembly comprising a plurality of leaflets, each leaflet having an inner surface and an outer surface; and a crimping accessory device comprising an elongate shaft and at least one axially-extending finger having a proximal portion disposed between a proximal portion of the inner surface of the annular frame and a proximal portion of the outer surface of a leaflet of the plurality of leaflets, the at least one axially-extending finger having a distal portion extending outwardly through, and radially outwardly from, a frame window.

10 . The assembly of claim 9 , wherein the at least one axially-extending finger is formed from the elongate shaft and extends from the elongate shaft in a cantilevered manner.

11 . The assembly of claim 9 , wherein the at least one axially-extending finger extends from the elongate shaft in a cantilevered manner.

12 . The assembly of claim 9 , wherein the elongate shaft extends through proximal and distal ends of the prosthetic valve.

13 . The assembly of claim 9 , wherein the crimping accessory device comprises a plurality of sets of fingers of the plurality of axially-extending figures, each set of the plurality of sets including at least two fingers of the plurality of axially-extending fingers, each set corresponding to a leaflet of the prosthetic valve, each set comprising at least one finger of the plurality of axially-extending fingers disposed between the outer surface of a leaflet of the plurality of leaflets and the inner surface of the frame, and at least another finger of the plurality of axially-extending fingers disposed inwardly of the inner surface of the respective leaflet.

14 . A method for compressing a prosthetic valve, the prosthetic valve comprising a radially expandable and compressible annular frame and a leaflet assembly mounted inside of the annular frame, in cooperation with a crimping accessory device, the method comprising:
inserting each of a first group of one or more fingers of a plurality of fingers of the crimping accessory device between an inner surface of the annular frame and an outer surface of a respective leaflet; placing each of a second group of one or more fingers of the plurality of fingers against an inner surface of a respective leaflet; placing the prosthetic valve in a crimping aperture formed by a plurality of circumferentially-arranged jaws; at least partially crimping the prosthetic valve; and removing the crimping accessory device from the prosthetic valve after at least partially crimping the prosthetic valve.

15 . The method of claim 14 , wherein the crimping accessory device comprises a plurality of sets of fingers, each set comprising at least one finger of the first group and at least one finger of the second group, each set corresponding to a leaflet of the prosthetic valve.

16 . The method of claim 14 , wherein at least one finger of the first group and at least one finger of the second group are circumferentially spaced apart from one another in a first set, and at least another finger of the first group and at least another finger of the second group are circumferentially spaced apart from one another in a second set, the first and second sets being spaced circumferentially further apart from one another than the spacing between the fingers within the first and second sets.

17 . The method of claim 14 , wherein at least one finger of the plurality of fingers comprises a hook formed on an outer surface of the at least one finger.

18 . The method of claim 14 , wherein fingers of the second group are formed from a resilient material, and the fingers of the second group are deflected radially-inwardly and exert a radially-outwardly directed force against the inner surface of a respective leaflet.

19 . The method of claim 14 , further comprising:
securing the crimping accessory device to the prosthetic valve prior to crimping or radially compressing the prosthetic valve; and releasing the crimping accessory device from the prosthetic valve after crimping or radially compressing the prosthetic valve.

20 . The method of claim 19 , wherein securing the crimping accessory device to the prosthetic valve comprises coupling the crimping accessory device to the prosthetic valve using one or more lines of suture.

Assignees

• Edwards Lifesciences Corp

Inventors

• Scheinblum Taylor Jacob
• Black Mindy Lee Ann
• Levi Tamir S
• Schwartz Evan T
• Chu Waina Michelle
• Thai Linda
• Cohen-Tzemach Hanoch
• Bukin Michael

Classifications

• A61F2/95

  Instruments specially adapted for placement or removal of stents or stent-grafts · CPC title

• B25B27/02

  for connecting objects by press fit or detaching same {(B25D1/16 takes precedence)} · CPC title

• A61F2/2412 Primary

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title

• A61F2230/005

  Rosette-shaped, e.g. star-shaped · CPC title

• A61F2/2418

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