IP Library › Granted Patent US 11,278,409
Granted Patent B2
US 11,278,409 · App. 16/290,572 · Granted Mar 22, 2022

Heart valve sealing devices and delivery devices therefor

Inventors: Alex Philip McCann (Lake Forest, CA); Grant Matthew Stearns (Tustin, CA); Eric Robert Dixon (Villa Park, CA); Yoon Hee Kwon (Mission Viejo, CA)
Assignee: Edwards Lifesciences Corporation
A61F2/2466A61B17/00234A61B17/0469A61B17/3468A61F2/246A61F2/2448A61F2/2463A61B17/0401A61B2017/00243A61B2017/00557A61B2017/00783A61B2017/00867A61B2017/0464A61F2/2445A61F2210/0014A61F2220/0016A61F2220/0041A61F2220/0091A61F2230/0093A61F2240/001A61F2250/0003
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Quick Facts
Patent No.
US 11,278,409
App. No.
16/290,572
Granted
Mar 22, 2022
Kind
B2
Abstract

A method of manufacturing a valve repair device for repairing a native valve of a patient includes: folding a strip of material formed from shape-memory alloy around a jig to form a coaption element and a pair of paddles connected to the coaption element, wherein the paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient; and heat treating the strip of material to shape-set the strip of material in the shape of the coaption element and paddles.

Claims (68)

1. A method of manufacturing a valve repair device for repairing a native valve of a patient, the method comprising:

folding a strip of material formed from shape-memory alloy around a jig to form a coaption element and a pair of paddles connected to the coaption element, wherein the paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient; and

heat-treating the strip of material to shape-set the strip of material in the shape of the coaption element and paddles.

2. The method of claim 1 , wherein the jig further comprises plurality of jig portions.

3. The method of claim 2 , wherein the strip of material is folded around each of the plurality of jig portions.

4. The method of claim 2 , wherein the strip of material is folded more than once around one of the plurality of jig portions.

5. The method of claim 1 , wherein the jig further comprises first, second, third, and fourth jig portions.

6. The method of claim 5 , wherein folding the strip of material around the jig comprises:

folding the strip of material around the first jig portion;

folding the strip of material around the second jig portion;

folding the strip of material around the first jig portion a second time;

folding the strip of material around the third jig portion; and

folding the strip of material around the fourth jig portion.

7. The method of claim 5 , wherein the first jig portion is larger than the second, third, and fourth jig portions.

8. The method of claim 5 , wherein the jig portions are cylindrical, and the first jig portion has a larger diameter than a diameter of the second, third, and fourth jig portions.

9. The method of claim 5 , wherein the second jig portion is closer to a proximal end of the valve repair device than the first, third, and fourth jig portions.

10. The method of claim 5 , wherein the fourth jig portion is closer to a distal end of the valve repair device than the first, second, and third jig portions.

11. The method of claim 5 , wherein the first and third jig portions are arranged closer to a proximal end of the valve repair device than the fourth jig portion.

12. The method of claim 5 , wherein:

the second jig portion is the closest jig portion to a proximal end of the valve repair device;

the fourth jig portion is the closest jig portion to a distal end of the valve repair device; and

the first and third jig portions are arranged between the second and fourth jig portions.

13. The method of claim 12 , wherein the first jig portion is arranged between the fourth jig portion and the third jig portion.

14. The method of claim 5 , wherein each jig portion comprises a pair of jig portions.

15. The method of claim 14 , wherein folding the strip of material around the jig comprises:

folding the strip of material around one of the first jig portions;

folding the strip of material around one of the second jig portions;

folding the strip of material around one of the first jig portions a second time;

folding the strip of material around one of the third jig portions;

folding the strip of material around one of the fourth jig portions;

folding the strip of material around the other of the fourth jig portions;

folding the strip of material around the other of the third jig portions;

folding the strip of material around the other of the first jig portions;

folding the strip of material around the other of the second jig portions; and

folding the strip of material around the other of the first jig portions a second time.

16. The method of claim 5 , wherein a proximal end of the coaption element is formed by folding the strip of material around the second jig portion.

17. The method of claim 5 , wherein a distal end of the paddles is formed by folding the strip of material around the fourth jig portion.

18. The method of claim 5 , wherein the paddles comprise an inner paddle portion and an outer paddle portion and a hinge between the inner and outer paddle portions is formed by folding the strip of material around the third jig portion.

19. The method of claim 5 , wherein the first jig portion is cylindrical and has a diameter of about 1.0 mm.

20. The method of claim 5 , wherein the second jig portion is cylindrical and has a diameter of about 0.4 mm.

21. The method of claim 5 , wherein the third jig portion is cylindrical and has a diameter of about 0.35 mm.

22. The method of claim 5 , wherein the fourth jig portion is cylindrical and has a diameter of about 0.6 mm.

23. A valve repair device for repairing a native valve of a patient, the valve repair device comprising:

a strip of material formed from a shape-memory alloy;

a coaption element formed from the strip of material; and

a pair of paddles formed from the strip of material and connected to the coaption element, wherein the paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient; and wherein the strip of material is folded around a jig and heat treated to shape-set the strip of material in the shape of the coaption element and paddles.

24. The valve repair device of claim 23 , wherein the jig further comprises plurality of jig portions.

25. The valve repair device of claim 24 , wherein the strip of material is folded around each of the plurality of jig portions.

26. The valve repair device of claim 24 , wherein the strip of material is folded more than once around one of the plurality of jig portions.

27. The valve repair device of claim 23 , wherein the jig further comprises first, second, third, and fourth jig portions.

28. The valve repair device of claim 27 , wherein the first jig portion is larger than the second, third, and fourth jig portions.

29. The valve repair device of claim 27 , wherein the jig portions are cylindrical, and the first jig portion has a larger diameter than a diameter of the second, third, and fourth jig portions.

30. The valve repair device of claim 27 , wherein the second jig portion is closer to a proximal end of the valve repair device than the first, third, and fourth jig portions.

31. The valve repair device of claim 27 , wherein the fourth jig portion is closer to a distal end of the valve repair device than the first, second, and third jig portions.

32. The valve repair device of claim 27 , wherein the first and third jig portions are arranged closer to a proximal end of the valve repair device than the fourth jig portion.

33. The valve repair device of claim 27 , wherein:

the second jig portion is the closest jig portion to a proximal end of the valve repair device;

the fourth jig portion is the closest jig portion to a distal end of the valve repair device; and

the first and third jig portions are arranged between the second and fourth jig portions.

34. The valve repair device of claim 33 , wherein the first jig portion is arranged between the fourth jig portion and the third jig portion.

35. The valve repair device of claim 27 , wherein each jig portion comprises a pair of jig portions.

36. The valve repair device of claim 27 , wherein a proximal end of the coaption element is formed by folding the strip of material around the second jig portion.

37. The valve repair device of claim 27 , wherein a distal end of the paddles is formed by folding the strip of material around the fourth jig portion.

38. The valve repair device of claim 27 , wherein the paddles comprise an inner paddle portion and an outer paddle portion and a hinge between the inner and outer paddle portions is formed by folding the strip of material around the third jig portion.

39. The valve repair device of claim 27 , wherein the first jig portion is cylindrical and has a diameter of about 1.0 mm.

40. The valve repair device of claim 27 , wherein the second jig portion is cylindrical and has a diameter of about 0.4 mm.

41. The valve repair device of claim 27 , wherein the third jig portion is cylindrical and has a diameter of about 0.35 mm.

42. The valve repair device of claim 27 , wherein the fourth jig portion is cylindrical and has a diameter of about 0.6 mm.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 11, 2019
From: MCCANN, ALEX PHILIP; STEARNS, GRANT MATTHEW; DIXON, ERIC ROBERT; KWON, YOON HEE
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 048863/0243 →
Continuity (2)
Provisional Application 62744031 · Oct 10, 2018
Related Publication 20200113694A1 · Apr 16, 2020
Cited By (4)
US 12,290,439 US 12,370,048 US 12,396,855 US 12,433,749