Wide clip with nondeformable wings

Patent metadata

Field	Value
Publication number	US-11660189-B2
Application number	US-202016928599-A
Country	US
Kind code	B2
Filing date	Jul 14, 2020
Priority date	Jul 15, 2019
Publication date	May 30, 2023
Grant date	May 30, 2023

Abstract

Fixation device for fixation of leaflets of a heart valve includes a central assembly and at least one arm moveably coupled to the central assembly. The at least one arm includes a body portion having a first end and a second end and a longitudinal axis defined therebetween, the second end being moveable between a closed position and an open position, the body portion having opposing body lateral sides, each body lateral side extending between the first end and the second end, the body portion having a body portion width defined between the opposing body lateral sides. The at least one arm further includes first and second nondeformable wing extensions, each wing extension extending laterally from a respective lateral side, each wing extension having a lateral outer edge, wherein a maximum arm width is defined between the outer lateral edge of the first wing extension and the outer lateral edge of the second wing extension. The fixation device further includes at least one gripping element moveable relative to the at least one arm to capture a native leaflet therebetween.

First claim

The invention claimed is:

1. A fixation device for fixation of leaflets of a heart valve comprising:
a central assembly;
at least one arm moveably coupled to the central assembly, the at least one arm comprising:
a body portion having a first end and a second end and a longitudinal axis defined therebetween, the second end being moveable between a closed position and an open position, the body portion having opposing body lateral sides, each body lateral side extending between the first end and the second end, the body portion having a body portion width defined between the opposing body lateral sides,
first and second nondeformable wing extensions, each wing extension extending laterally from a respective lateral side, each wing extension having a lateral outer edge, wherein a maximum arm width is defined between the outer lateral edge of the first wing extension and the outer lateral edge of the second wing extension;
wherein the first and second wing extensions each have a first end edge and a second end edge, wherein the first end edge extends between the respective body lateral side and the outer lateral edge and is located proximate the first end of the body portion, and the second end edge extends between the respective body lateral side and the outer lateral edge and is located proximate the second end of the body portion, and
wherein the first end edge has a first end fillet at an intersection with the respective body lateral side, wherein the first end fillet has a radius of curvature between one and eleven times a thickness of the arm; and

at least one gripping element moveable relative to the at least one arm to capture a native leaflet therebetween.

2. The device of claim 1 , wherein the maximum arm width is between about 1.40 and 1.60 times the body portion width.

3. The device of claim 1 , wherein the maximum arm width is about 1.50 times the body portion width.

4. The device of claim 1 , wherein the first end edge extends from the body lateral side at a first end angle defined between the first end edge and the longitudinal axis, wherein the first end angle is between 30 and 60 degrees.

5. The device of claim 4 , wherein the first end angle is 45 degrees.

6. The device of claim 4 , wherein a first end lead dimension is defined along the body portion by a distance between the first end of the body portion and an intersection of the first end edge and the respective body lateral side, wherein the first end lead dimension is between about 0.15 inch and 0.25 inch.

7. The device of claim 6 , wherein the first end lead dimension is 0.19 inch.

8. The device of claim 4 , wherein a second end lead dimension is defined along the body portion by a distance between the second end of the body portion and an intersection of the second end edge and the respective body lateral side, wherein the second end lead dimension is between about 0.05 inch and 0.15 inch.

9. The device of claim 8 , wherein the second end lead dimension is 0.09 inch.

10. The device of claim 4 , wherein a first end lead dimension is defined along the body portion by a distance between the first end of the body portion and an intersection of the first end edge and the respective body lateral side, and a second end lead dimension is defined along the body portion by a distance between the second end of the body portion and an intersection of the second end edge and the respective body lateral side, and the second end lead dimension is less than one third of the first end lead dimension.

11. The device of claim 1 , wherein the second end edge extends from the respective body lateral side at a second end angle defined between the second end edge and the longitudinal axis, wherein the second end angle is between 30 and 60 degrees.

12. The device of claim 11 , wherein the second end angle is 45 degrees.

13. The device of claim 1 , wherein the arm has a thickness of about 0.015 inch.

14. The device of claim 1 , wherein the first end fillet has a radius of curvature between about 0.02 inch and 0.165 inch.

15. The device of claim 1 , wherein the first end fillet has a radius of curvature of 0.12 inch.

16. The device of claim 1 , wherein the first end fillet has a radius of curvature eight times the thickness of the arm.

17. The device of claim 1 , wherein a second end edge extends from the second end of the body portion at a second end angle defined between the second end edge and the longitudinal axis, wherein the second end angle is between 30 and 60 degrees.

18. The device of claim 1 , wherein the first end edge, lateral outer edge, and second end edge form a continuous complex curve.

19. The device of claim 1 , wherein the at least one arm further has a recessed trough along the longitudinal axis, the trough having a trough width sized greater than a width of the at least one gripping element.

20. The device of claim 19 , wherein the trough width increases from the first end of the body portion to the second end of the body portion.

21. The device of claim 1 , wherein the first and second wing extensions and the body portion are a single piece.

22. The device of claim 1 , wherein each first and second wing extension in end cross-section extends laterally from the respective body lateral side and then extends perpendicularly to the outer lateral edge.

23. The device of claim 22 , wherein the fixation device comprises a second arm moveably coupled to the central assembly, the second arm comprising a body portion having a first end and a second end, the second end being moveable between a closed position and an open position, wherein in the closed position, the at least one arm is sized to surround the second arm on at least three sides of the at least one arm.

24. The device of claim 1 , wherein each first and second wing extension in end cross-section extends at a wing extension angle defined between the wing extension and a reference axis extending through the opposing body lateral sides of each respective first and second wing extension, wherein the wing extension angle is between 125 and 145 degrees.

25. The device of claim 1 , wherein the wing extension angle is about 135 degrees.

26. The device of claim 1 , wherein the at least one gripping element has at least one friction element along a length thereof.

27. The device of claim 26 , wherein the at least one gripping element has a plurality of friction elements along the length thereof, wherein when the at least one gripping element is located proximate the at least one arm the plurality of friction elements are disposed along a length defined between the intersection of the first end edge and the respective body lateral side, and the intersection of the second end edge and the respective body lateral side.

28. The device of claim 1 , wherein the fixation device further comprises:
a second arm moveably coupled to the central assembly, the second arm comprising a second body portion having a first end and a second end, the second end being moveable between a closed position and an open position; and
a second gripping element moveable relative to the second arm to capture a native leaflet therebetween.

29. A fixation device for fixation of leaflets of a heart valve comprising:
a central assembly;
at least one arm moveably coupled to the central assembly, the at least one arm comprising:
a body portion having a first

Assignees

• Evalve Inc

Inventors

• Abunassar Chad
• Garcia Jessie
• Gonzales Gabriel
• Jain Samir
• Barbarino Casey
• Prabhu Santosh

Classifications

• A61F2250/0037

  differing in height or in length · CPC title

• A61F2250/0036

  differing in thickness · CPC title

• A61F2/246 Primary

  Devices for obstructing a leak through a native valve in a closed condition · CPC title

• A61F2/2475

  Venous valves · CPC title

• A61F2230/0093

  Umbrella-shaped, e.g. mushroom-shaped · CPC title