Crimping accessory device for a prosthetic valve

Patent metadata

Field	Value
Publication number	US-12138155-B2
Application number	US-202117228446-A
Country	US
Kind code	B2
Filing date	Apr 12, 2021
Priority date	Nov 17, 2016
Publication date	Nov 12, 2024
Grant date	Nov 12, 2024

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 annular 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, respective leaflets of the plurality of leaflets having an inner surface and an outer surface; and
a crimping accessory device comprising a shaft and a plurality of axially-extending fingers fixedly secured to an end of the shaft and interposed between the inner surface of the frame and an outer surface of a first leaflet of the plurality of leaflets such that:
(1) along a defined radial distance from an axis extending through the shaft of the crimping accessory device, an inner surface of a first axially-extending finger of the plurality of axially-extending figures is adjacent the outer surface of the first leaflet and an opposing outer surface of the first axially-extending finger is adjacent the inner surface of the frame; and
(2) a second leaflet of the plurality of leaflets is interposed between an outer surface of a second finger of the plurality of axially-extending fingers and an inner surface of the frame, such that, along a defined radial distance from the axis extending through the shaft of the crimping accessory device, the second leaflet is adjacent to an outer surface of a second finger of the plurality of axially-extending fingers and is adjacent to an inner surface of the frame, 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.

2. The assembly of claim 1 , further comprising:
a hook formed on an outer surface of the first axially-extending finger at a location spaced apart proximally from a distal end of the first axially-extending finger, at least a portion of the hook extending about the outer surface of the frame.

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

4. The assembly of claim 3 , 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.

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

6. The assembly of claim 4 , wherein the aperture is not accessible from a proximal, longitudinal side of the hook.

7. The assembly of claim 1 , the plurality of leaflets defining a plurality of leaflet commissures connected to the annular frame, wherein the plurality of leaflets are joined at respective leaflet commissures and a finger of the plurality of axially-extending fingers is disposed proximate each side of the respective leaflet commissure.

8. 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, respective leaflets of the plurality of leaflets having an inner surface and an outer surface; and
a crimping accessory device comprising an elongate shaft and a plurality of axially-extending fingers, at least a first axially-extending finger of the plurality of axially-extending fingers having a proximal portion interposed 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 a first axially-extending finger having a distal portion extending outwardly through, and radially outwardly from, a frame window of the plurality of frame windows such that, along a defined radial distance from an axis extending through the elongate shaft of the crimping accessory device, an inner surface of the at least a first axially-extending finger is adjacent the outer surface of the first leaflet and an opposing outer surface of the at least a first axially-extending finger is adjacent the inner surface of the frame; and
a plurality of sets of axially-extending fingers formed from at least a portion of the plurality of axially-extending fingers, the at least a first axially extending finger being part of a set of the plurality of sets, given sets of the plurality of sets including at least two fingers of the plurality of axially-extending fingers, given sets corresponding to a leaflet of the prosthetic valve, given sets comprising at least one finger of the plurality of axially-extending fingers interposed between, and adjacent to, 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 interposed inwardly of the inner surface of the respective leaflet.

9. The assembly of claim 8 , wherein the at least a first axially-extending finger is formed from the elongate shaft and extends from the elongate shaft in a cantilevered manner.

10. The assembly of claim 8 , wherein the at least a first axially-extending finger extends from the elongate shaft in a cantilevered manner.

11. The assembly of claim 8 , wherein the elongate shaft extends through proximal and distal ends of the prosthetic valve.

12. 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 such that, along a defined radial distance from an axis extending through a shaft of the crimping accessory device, an inner surface of at least one finger of the first group of one or more fingers is adjacent the outer surface of its respective first leaflet and an opposing outer surface of the at least one finger of the first group of one or more fingers is adjacent the inner surface of the frame;
placing respective fingers of a second group of one or more fingers of the plurality of fingers against an inner surface of a respective leaflet, 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;
placing the prosthetic valve with the inserted crimping accessory device in a crimping aperture of a crimping device formed by a plurality of circumferentially-arranged jaws of the crimping device;
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 using the crimping device.

13. The method of claim 12 , wherein the crimping accessory device comprises a plurality of sets of fingers, respective sets of the plurality of sets of fingers 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.

14. The method of claim 12 , 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,

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

• B25B27/02

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

• A61F2/95

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

• A61F2/2454

  Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses · CPC title

• A61F2/2433

  using balloon catheter · CPC title

• A61F2/2403

  with pivoting rigid closure members (check valves with hinged closure members in general F16K15/03) · CPC title