Mitral valve treatment techniques

• US 10,561,498 B2
• Filed: 11/23/2016
• Issued: 02/18/2020
• Est. Priority Date: 03/17/2005
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Gross, Amir, Gross, Yossi
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US15/360,224
• Publication Number:
  US 20170135815A1
• Time in Patent Office: 1,182 Days
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/0007 for adjusting length
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers

Abstract

A method for treating a heart valve of a patient includes inserting into a heart and in contact with a valve surface, an implant including an elongate element and a locking mechanism coupled to the elongate element. The locking mechanism has a resting position that provides a locked state preventing movement of the elongate element with respect to the locking mechanism. The heart valve is treated by facilitating movement of the elongate element with respect to the locking mechanism by maintaining application of a force to the locking mechanism using a tool, and thereby maintaining the locking mechanism in an unlocked state during the facilitating of the movement of the elongate element with respect to the locking mechanism. Subsequently, the locking mechanism is transitioned to the resting position by decoupling the tool from the locking mechanism.

Claims

1. A method for treating a heart valve of a patient, the method comprising:

inserting into a heart of the patient and in contact with a valve surface of the heart valve, an implant including an elongate element and a locking mechanism coupled to the elongate element, the locking mechanism having a resting position that provides a locked state in which movement of the elongate element with respect to the locking mechanism is prevented;

subsequently to the inserting, performing annuloplasty on the heart valve of the patient by increasing tension of the elongate element by maintaining application of a force to the locking mechanism using a tool, and thereby maintaining the locking mechanism in an unlocked state during the increasing of the tension of the elongate element; and

subsequently to the performing of the annuloplasty on the heart valve and subsequently to coupling proximal and distal ends of the implant to tissue at the heart valve, transitioning the locking mechanism to the resting position by decoupling the tool from the locking mechanism.

2. The method according to claim 1, wherein inserting comprises positioning the implant in contact with a ventricular surface of the heart valve.

3. The method according to claim 1, wherein increasing the tension of the elongate element comprises facilitating sliding of the locking mechanism along the elongate element.

4. The method according to claim 1, wherein the locking mechanism includes a clip, and wherein transitioning the locking mechanism to the resting position comprises facilitating changing a shape of the clip.

5. The method according to claim 1, wherein:

the locking mechanism is shaped so as to define one or more release sites,

the tool includes one or more force application elements, and

maintaining application of the force to the locking mechanism using the tool comprises maintaining application of the force to the one or more release sites of the locking mechanism by a respective one of the one or more force application elements of the tool.

6. The method according to claim 1, wherein performing of the annuloplasty on the heart valve comprises tightening an annulus of the valve.

7. The method according to claim 1, wherein inserting the implant comprises inserting the elongate element and the locking mechanism at the same time.

8. The method according to claim 1, wherein inserting the implant comprises inserting the elongate element and the locking mechanism while the elongate element is coupled to the locking mechanism.

9. The method according to claim 1, wherein coupling the proximal and distal ends of the implant comprises:

coupling a proximal coupling element at the proximal end of the implant to a first portion of chordae tendineae; and

coupling a distal coupling element at the distal end of the implant to a second portion of chordae tendineae.

10. The method according to claim 1, wherein maintaining the locking mechanism in the unlocked state comprises, using the tool, changing a shape of the locking mechanism and maintaining a changed shape of the locking mechanism during the performing of the annuloplasty.

11. The method according to claim 10, wherein changing the shape of the locking mechanism comprises applying a force to a portion of the locking mechanism in order to facilitate the changing of the shape.

12. The method according to claim 1, wherein inserting comprises transcatheterally inserting.

13. The method according to claim 1, wherein increasing the tension comprises adjusting the tension of the elongate element based on feedback.

14. A method for treating a heart valve of a patient, the method comprising:

inserting into a heart of the patient and in contact with a valve surface of the heart valve an implant including an elongate element and only one locking mechanism coupled to the elongate element, the locking mechanism having a resting position that provides a locked state in which movement of the elongate element with respect to the locking mechanism is prevented; and

while a tool is engaged with the locking mechanism, performing annuloplasty on the heart valve of the patient by, using the tool;

applying a force to the locking mechanism and thereby transitioning the locking mechanism out of the resting position into an unlocked state; and

increasing a tension of the elongate element; and

subsequently to the performing of the annuloplasty on the heart valve, transitioning the locking mechanism to the resting position by decoupling the tool from the locking mechanism.

15. The method according to claim 14, wherein inserting comprises positioning the implant in contact with a ventricular surface of the heart valve.

16. The method according to claim 14, wherein increasing the tension of the elongate element comprises facilitating sliding of the locking mechanism along the elongate element.

17. The method according to claim 14, wherein the locking mechanism includes a clip wherein transitioning the locking mechanism out of the resting position comprises facilitating changing a shape of the clip.

18. The method according to claim 14, wherein:

the locking mechanism is shaped so as to define one or more release sites,

the tool includes one or more force application elements, and

applying the force to the locking mechanism comprises applying the force to the one or more release sites of the locking mechanism by a respective one of the one or more force application elements of the tool.

19. The method according to claim 14, wherein performing the annuloplasty on the heart valve comprises tightening an annulus of the valve.

20. The method according to claim 14, wherein inserting the implant comprises inserting the elongate element and the locking mechanism at the same time.

21. The method according to claim 14, wherein inserting the implant comprises inserting the elongate element and the locking mechanism while the elongate element is coupled to the locking mechanism.

22. The method according to claim 14, further comprising coupling proximal and distal ends of the elongate element to respective portions of heart tissue.

23. The method according to claim 22, wherein coupling the proximal and distal ends of the elongate element comprises:

coupling a proximal coupling element at the proximal end of the elongate element to a first portion of chordae tendineae; and

coupling a distal coupling element at the distal end of the elongate element to a second portion of chordae tendineae.

24. The method according to claim 14, wherein applying the force to the locking mechanism comprises, using the tool, changing a shape of the locking mechanism and maintaining a changed shape of the locking mechanism during the performing of the annuloplasty.

25. The method according to claim 14, wherein inserting comprises transcatheterally inserting.

26. The method according to claim 14, wherein increasing the tension comprises adjusting the tension of the elongate element based on feedback.