IP Library › Granted Patent US 11,660,190

Granted Patent B2

US 11,660,190 · App. 16/268,592 · Granted May 30, 2023

Tissue anchors, systems and methods, and devices

Inventors: Paul A. Spence (Louisville, KY); Donald S. Baim (Westwood, MA); Edward I. McNamara (Chelmsford, MA); Hiroatsu Sugimoto (Cambridge, MA); Joseph P. Lane (Methuen, MA); Jason H. Robinson (Windham, NH); Aaron M. Call (Mesa, AZ); Steven D. Cahalane (Pelham, NH); Mark Maguire (Hillsborough, CA); Kate E. Cutuli (Salem, NH)

Assignee: EDWARDS LIFESCIENCES CORPORATION

A61F2/2466 A61B17/0057 A61B17/00234 A61B17/0401 A61B17/0469 A61B17/0487 A61B17/06166 A61F2/2427 A61F2/2442 A61F2/2445 A61B17/0467 A61B90/39 A61B2017/00243 A61B2017/00637 A61B2017/00659 A61B2017/048 A61B2017/0411 A61B2017/0417 A61B2017/0419 A61B2017/0464 A61B2017/0488 A61B2017/0496 A61B2017/0619 A61B2090/0811 A61B2090/3966 A61F2250/0007 A61F2250/0098

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Quick Facts

Patent No.: US 11,660,190
App. No.: 16/268,592
Granted: May 30, 2023
Kind: B2

External Links

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Abstract

Systems, devices and methods for securing tissue including the annulus of a mitral valve. The systems, devices and methods may employ catheter based techniques and devices to plicate tissue and perform an annuloplasty.

Claims (102)

1. A method of cutting a flexible tensile member located within a heart of a patient, the method comprising:

introducing, into the patient, a blade that defines an aperture therethrough, an inner perimeter of the blade:

enclosing the aperture, and

having a distal region and a proximal region, the distal region defining a proximally-facing cutting edge;

with the flexible tensile member threaded through the aperture, transluminally advancing the blade distally to the heart by sliding the aperture over and along the flexible tensile member with the cutting edge facing the flexible tensile member; and

subsequently, cutting the flexible tensile member by pulling the blade proximally, such that the cutting edge moves proximally through the flexible tensile member.

2. The method of claim 1 , wherein transluminally advancing the blade distally to the heart comprises advancing the blade through a catheter.

3. The method of claim 1 , wherein cutting the flexible tensile member comprises cutting the flexible tensile member against an anvil.

4. The method according to claim 1 , wherein the blade is a component of a suture cutter that includes a housing, and wherein introducing the blade into the patient comprises introducing the blade into the patient while the blade is disposed within the housing.

5. The method according to claim 4 , wherein cutting the flexible tensile member by pulling the blade proximally comprises cutting the flexible tensile member by pulling the blade proximally with respect to the housing.

6. The method according to claim 4 , wherein the housing defines an internal slot, and wherein transluminally advancing the blade distally to the heart by sliding the aperture over and along the flexible tensile member comprises transluminally advancing the blade distally to the heart by sliding the aperture over and along the flexible tensile member while the cutting edge is concealed within the internal slot.

7. The method according to claim 6 , wherein cutting the flexible tensile member by pulling the blade proximally comprises cutting the flexible tensile member by pulling the blade proximally such that the cutting edge moves proximally within the internal slot towards the flexible tensile member.

8. The method according to claim 7 , wherein the housing defines a blade-restraining floor at a proximal end of the internal slot, configured to limit proximal movement of the blade within the internal slot, and wherein cutting the flexible tensile member by pulling the blade proximally comprises cutting the flexible tensile member by pulling the blade proximally until at least a part of the blade abuts the blade-restraining floor.

9. The method according to claim 4 , wherein:

the housing defines a longitudinal axis,

the blade is flat, thereby defining a blade plane,

the blade extends, within the housing, along the longitudinal axis, and

cutting the flexible tensile member by pulling the blade proximally comprises cutting the flexible tensile member by pulling the blade proximally such that the blade moves axially within the housing.

10. The method according to claim 9 , wherein the cutting edge is (i) on the blade plane, and (ii) oblique with respect to the longitudinal axis, and wherein cutting the flexible tensile member by pulling the blade proximally comprises cutting the flexible tensile member by pulling the blade proximally such that the blade moves axially within the blade plane.

11. The method according to claim 9 , wherein:

the housing defines a distal suture port at a first side of the blade plane, and a proximal suture port at a second side of the blade plane, the second side being opposite to the first side,

the aperture is disposed on the blade plane, and

transluminally advancing the blade distally to the heart by sliding the aperture over and along the flexible tensile member comprises transluminally advancing the blade distally to the heart by sliding the aperture over and along the flexible tensile member with the flexible tensile member disposed through (i) the distal suture port, (ii) the aperture of the blade, and (iii) the proximal suture port.

12. The method according to claim 11 , wherein cutting the flexible tensile member comprises cutting the flexible tensile member in the blade plane.

13. The method according to claim 11 , wherein:

the distal suture port is disposed at a distal end of the housing, facing distally,

the proximal suture port is disposed at a lateral wall of the housing, and

transluminally advancing the blade distally to the heart by sliding the aperture over and along the flexible tensile member, with the flexible tensile member disposed through the aperture comprises transluminally advancing the blade distally to the heart by sliding the aperture over and along the flexible tensile member such that a portion of the flexible tensile member extends:

into the distal suture port, substantially parallel to the blade plane,

within the suture cutter, oblique to the blade plane, through the aperture and toward the proximal suture port, and

out of the proximal suture port, and proximally alongside the suture cutter.

14. The method according to claim 1 , wherein the flexible tensile member is a first flexible tensile member of multiple flexible tensile members, and wherein:

cutting the flexible tensile member by pulling the blade proximally comprises cutting the multiple flexible tensile members by pulling the blade proximally, such that the cutting edge moves proximally through the multiple flexible tensile members.

15. The method according to claim 1 , wherein the blade is planar, and wherein introducing the blade into the patient comprises introducing, into the patient, the blade that is planar.

16. The method according to claim 1 , wherein the blade is a guillotine-style blade, and wherein introducing the blade into the patient comprises introducing the guillotine-style blade into the patient.

17. The method according to claim 1 , wherein the blade is coupled to an actuating element, and wherein cutting the flexible tensile member by pulling the blade proximally comprises actuating the actuating element to pull the blade proximally, thereby cutting the flexible tensile member.

18. A method of cutting a flexible tensile member located within a patient, the method comprising:

introducing, into the patient, a blade that:

defines an aperture therethrough, an inner perimeter of the blade delineating the aperture and defining a proximally-facing cutting edge, and

is disposed within a housing that defines (i) an internal slot, and (ii) a blade-restraining floor at a proximal end of the internal slot, configured to limit proximal movement of the blade within the internal slot;

while the cutting edge is concealed within the internal slot, transluminally advancing the blade over and along the flexible tensile member, with the flexible tensile member disposed through the aperture; and

cutting the flexible tensile member by pulling the blade proximally such that the cutting edge moves proximally within the internal slot towards and through the flexible tensile member, until at least a part of the blade abuts the blade-restraining floor.

19. The method according to claim 18 , wherein the inner perimeter has a distal region and a proximal region, the distal region defining the cutting edge, and wherein transluminally advancing the blade comprises transluminally advancing the blade over and along the flexible tensile member with the cutting edge facing the flexible tensile member.

20. The method according to claim 18 , wherein the flexible tensile member is a first flexible tensile member of multiple flexible tensile members, and wherein:

transluminally advancing the blade over and along the flexible tensile member comprises transluminally advancing the blade over and along the multiple flexible tensile members, and

21. The method according to claim 18 , wherein the blade is planar, and wherein introducing the blade into the patient comprises introducing, into the patient, the blade that is planar.

22. The method according to claim 18 , wherein the blade is a guillotine-style blade, and wherein introducing the blade into the patient comprises introducing the guillotine-style blade into the patient.

23. The method according to claim 18 , wherein:

the housing defines a longitudinal axis,

the blade is flat, thereby defining a blade plane,

the blade extends, within the housing, along the longitudinal axis, and

cutting the flexible tensile member by pulling the blade proximally comprises cutting the flexible tensile member by pulling the blade proximally such that the blade moves axially within the housing.

24. The method according to claim 23 , wherein the cutting edge is (i) on the blade plane, and (ii) oblique with respect to the longitudinal axis, and wherein cutting the flexible tensile member by pulling the blade proximally comprises cutting the flexible tensile member by pulling the blade proximally such that the blade moves axially within the blade plane.

25. The method according to claim 23 , wherein:

the housing defines a distal suture port at a first side of the blade plane, and a proximal suture port at a second side of the blade plane, the second side being opposite to the first side,

the aperture is disposed on the blade plane, and

transluminally advancing the blade over and along the flexible tensile member comprises transluminally advancing the blade over and along the flexible tensile member with the flexible tensile member disposed through (i) the distal suture port, (ii) the aperture of the blade, and (iii) the proximal suture port.

26. The method according to claim 25 , wherein cutting the flexible tensile member comprises cutting the flexible tensile member in the blade plane.

27. The method according to claim 25 , wherein:

the distal suture port is disposed at a distal end of the housing, facing distally,

the proximal suture port is disposed at a lateral wall of the housing, and

transluminally advancing the blade over and along the flexible tensile member, with the flexible tensile member disposed through the aperture comprises transluminally advancing the blade over and along the flexible tensile member such that a portion of the flexible tensile member extends:

into the distal suture port, substantially parallel to the blade plane,

within the suture cutter, oblique to the blade plane, through the aperture and toward the proximal suture port, and

out of the proximal suture port, and proximally alongside the suture cutter.

28. The method according to claim 18 , wherein the blade is coupled to an actuating element, and wherein cutting the flexible tensile member by pulling the blade proximally comprises actuating the actuating element to pull the blade proximally, thereby cutting the flexible tensile member.

29. A method of cutting a flexible tensile member located within a heart of a patient, the method comprising:

introducing, into the patient, a planar blade that defines an aperture therethrough, an inner perimeter of the planar blade enclosing the aperture and defining a proximally-facing cutting edge;

with the flexible tensile member threaded through the aperture, transluminally advancing the planar blade distally to the heart by sliding the aperture over and along the flexible tensile member; and

subsequently, cutting the flexible tensile member by pulling the planar blade proximally, such that the cutting edge moves proximally through the flexible tensile member.

30. The method of claim 29 , wherein transluminally advancing the planar blade distally to the heart comprises advancing the planar blade through a catheter.

31. The method of claim 29 , wherein cutting the flexible tensile member comprises cutting the flexible tensile member against an anvil.

32. The method according to claim 29 , wherein the inner perimeter has a distal region and a proximal region, the distal region defining the cutting edge, and wherein transluminally advancing the planar blade comprises transluminally advancing the planar blade over and along the flexible tensile member with the cutting edge facing the flexible tensile member.

33. The method according to claim 29 , wherein the planar blade is a component of a suture cutter that includes a housing, and wherein introducing the planar blade into the patient comprises introducing the planar blade into the patient while the planar blade is disposed within the housing.

34. The method according to claim 33 , wherein cutting the flexible tensile member by pulling the planar blade proximally comprises cutting the flexible tensile member by pulling the planar blade proximally with respect to the housing.

35. The method according to claim 33 , wherein the housing defines an internal slot, and wherein transluminally advancing the planar blade distally to the heart by sliding the aperture over and along the flexible tensile member comprises transluminally advancing the planar blade distally to the heart by sliding the aperture over and along the flexible tensile member while the cutting edge is concealed within the internal slot.

36. The method according to claim 35 , wherein cutting the flexible tensile member by pulling the planar blade proximally comprises cutting the flexible tensile member by pulling the planar blade proximally such that the cutting edge moves proximally within the internal slot towards the flexible tensile member.

37. The method according to claim 36 , wherein the housing defines a blade-restraining floor at a proximal end of the internal slot, configured to limit proximal movement of the planar blade within the internal slot, and wherein cutting the flexible tensile member by pulling the planar blade proximally comprises cutting the flexible tensile member by pulling the planar blade proximally until at least a part of the planar blade abuts the planar blade-restraining floor.

38. The method according to claim 29 , wherein the flexible tensile member is a first flexible tensile member of multiple flexible tensile members, and wherein:

transluminally advancing the planar blade distally to the heart by sliding the aperture over and along the flexible tensile member comprises transluminally advancing the planar blade distally to the heart by sliding the aperture over and along the multiple flexible tensile members, and

cutting the flexible tensile member by pulling the planar blade proximally comprises cutting the multiple flexible tensile members by pulling the planar blade proximally, such that the cutting edge moves proximally through the multiple flexible tensile members.

39. The method according to claim 29 , wherein the planar blade is a guillotine-style blade, and wherein introducing the planar blade into the patient comprises introducing the guillotine-style blade into the patient.

40. The method according to claim 29 , wherein the planar blade is coupled to an actuating element, and wherein cutting the flexible tensile member by pulling the planar blade proximally comprises actuating the actuating element to pull the planar blade proximally, thereby cutting the flexible tensile member.

41. A method of cutting a flexible tensile member located within a heart of a patient, the method comprising:

introducing, into the patient, a suture cutter that includes a housing that defines a longitudinal axis and that houses a flat blade that (i) defines a blade plane, the blade extending, within the housing, along the longitudinal axis, and (ii) defines an aperture therethrough, an inner perimeter of the blade enclosing the aperture and defining a proximally-facing cutting edge;

with the flexible tensile member threaded through the aperture, transluminally advancing the blade distally to the heart by sliding the aperture over and along the flexible tensile member; and

subsequently, cutting the flexible tensile member by pulling the blade proximally such that the blade moves axially within the housing and the cutting edge moves proximally through the flexible tensile member.

42. The method according to claim 41 , wherein the cutting edge is (i) on the blade plane, and (ii) oblique with respect to the longitudinal axis, and wherein cutting the flexible tensile member by pulling the blade proximally comprises cutting the flexible tensile member by pulling the blade proximally such that the blade moves axially within the blade plane.

43. The method according to claim 41 , wherein:

the housing defines a distal suture port at a first side of the blade plane, and a proximal suture port at a second side of the blade plane, the second side being opposite to the first side,

the aperture is disposed on the blade plane, and

44. The method according to claim 43 , wherein cutting the flexible tensile member comprises cutting the flexible tensile member in the blade plane.

45. The method according to claim 43 , wherein:

the distal suture port is disposed at a distal end of the housing, facing distally,

the proximal suture port is disposed at a lateral wall of the housing, and

into the distal suture port, substantially parallel to the blade plane,

within the suture cutter, oblique to the blade plane, through the aperture and toward the proximal suture port, and

out of the proximal suture port, and proximally alongside the suture cutter.

Assignments (2)

ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 22, 2019

From: MITRALIGN, INC.

To: EDWARDS LIFESCIENCES CORPORATION

Reel/Frame 049259/0001 →

ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 6, 2019

From: SPENCE, PAUL A.; BAIM, DONALD S.; MCNAMARA, EDWARD I.; SUGIMOTO, HIROATSU; LANE, JOSEPH P.; ROBINSON, JASON H.; CALL, AARON M.; CAHALANE, STEVEN D.; MAGUIRE, MARK; TRAYNOR, KATE E.

To: MITRALIGN, INC.

Reel/Frame 048247/0150 →