Adjustable annuloplasty devices and adjustment mechanisms therefor

• US 9,713,530 B2
• Filed: 12/11/2014
• Issued: 07/25/2017
• Est. Priority Date: 12/22/2008
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Kutzik, Meir, Zipory, Yuval, Cabiri, Oz, Gross, Amir, Sheps, Tal
• Primary Examiner(s): Matthews, Howie
• Application Number:
  US14/567,472
• Publication Number:
  US 20150105855A1
• Time in Patent Office: 957 Days
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/12095 Threaded connection
• 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 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

Apparatus is provided including an annuloplasty ring structure configured to be implanted in a body of a patient. The annuloplasty ring structure includes a flexible body portion and an adjusting mechanism configured to adjust a size of the body portion of the annuloplasty ring structure. The adjusting mechanism includes a housing. A coupling is attached to the housing and to the body portion and is configured to couple the housing to the body portion in a manner in which the housing is moveable with respect to the body portion. Other embodiments are also described.

Claims

1. A method, comprising:

delivering into a heart of a patient an annuloplasty ring structure configured to be implanted in a body of the patient, the annuloplasty ring structure including;

a flexible body portion;

a contracting member;

a housing;

an adjusting mechanism coupled to the contracting member and configured to adjust a size of the body portion of the annuloplasty ring structure by applying a pulling force to the contracting member, the adjusting mechanism disposed entirely within the housing; and

a coupling attached to the housing and to the body portion, the coupling being configured to couple the housing to the body portion in a manner in which the housing is moveable with respect to the body portion; and

following the delivering, moving the housing with respect to the body portion.

2. The method according to claim 1, wherein moving the housing with respect to the body portion comprises moving the housing with respect to the body portion while the body portion remains stationary.

3. The method according to claim 1, further comprising removably coupling the adjusting mechanism of the annuloplasty ring structure to a tool, and wherein the method further comprises adjusting a dimension of annuloplasty ring structure by actuating the adjusting mechanism using the tool.

4. The method according to claim 1, wherein moving the housing comprises swiveling the housing.

5. The method according to claim 1, wherein delivering the annuloplasty ring structure comprises transcatheterally advancing the annuloplasty ring structure into an atrium of the heart.

6. The method according to claim 1, wherein the annuloplasty ring structure includes a full annuloplasty ring structure.

7. The method according to claim 1, wherein the annuloplasty ring structure includes a partial annuloplasty ring structure.

8. The method according to claim 1, wherein the adjusting mechanism is coupled to one or more guide wires.

9. The method according to claim 1, wherein the contracting member extends along the body portion.

10. The method according to claim 9, wherein:

the body portion of the annuloplasty ring structure is compressible along a longitudinal axis of the annuloplasty ring structure,

the annuloplasty ring structure comprises a coiled structure having a lumen,

the contracting member is disposed within the lumen of the coiled structure, and

the method further comprises, using the adjusting mechanism, contracting the annuloplasty ring structure along the longitudinal axis by advancing portions of the contracting member toward the housing.

11. The method according to claim 1, further comprising coupling the annuloplasty ring structure to tissue of an annulus of the heart of the patient, and following the coupling, adjusting a dimension of the annulus by adjusting a dimension of the annuloplasty ring structure using the adjusting mechanism.

12. The method according to claim 11, wherein adjusting the dimension of the annuloplasty ring structure comprises bidirectionally rotating a rotatable structure of the adjusting mechanism.

25. The method according to claim 1, further comprising changing a shape of the annuloplasty ring structure from a linear state to a ring shape.

13. Apparatus, comprising an annuloplasty ring structure configured to be implanted in a heart of a patient, the annuloplasty ring structure comprising:

a flexible body portion;

a contracting member;

a housing;

an adjusting mechanism coupled to the contracting member and configured to adjust a size of the body portion of the annuloplasty ring structure by applying a pulling force to the contracting member, the adjusting mechanism disposed entirely within the housing; and

a coupling attached to the housing and to the body portion, the coupling being configured to couple the housing to the body portion in a manner in which the housing is moveable with respect to the body portion.

14. The apparatus according to claim 13, wherein the coupling is configured to couple the housing to the body portion in a manner in which the housing is moveable with respect to the body portion while the body portion remains stationary.

15. The apparatus according to claim 13, wherein the contracting member extends along the body portion.

16. The apparatus according to claim 13, wherein the adjusting mechanism comprises a rotatable structure.

17. The apparatus according to claim 13, wherein the coupling comprises a swivel coupling, and wherein the swivel coupling is configured to couple the housing to the body portion in a manner in which the housing swivels with respect to the body portion.

18. The apparatus according to claim 17, wherein the housing comprises at least one coupling member, and wherein the swivel coupling comprises at least one swivel snap which is coupled to the at least one coupling member of the housing to couple a first portion of the body portion to the housing.

19. The apparatus according to claim 13, wherein the annuloplasty ring structure comprises a full annuloplasty ring structure.

20. The apparatus according to claim 13, wherein the annuloplasty ring structure comprises a partial annuloplasty ring structure.

21. The apparatus according to claim 13, further comprising one or more guide wires, and wherein the adjusting mechanism is coupled to the one or more guide wires.

22. The apparatus according to claim 13, further comprising a tool removably couplable to the adjusting mechanism of the annuloplasty ring structure, wherein the tool is configured to adjust a dimension of the annuloplasty ring structure by actuating the adjusting mechanism.

23. The apparatus according to claim 13, wherein the annuloplasty ring structure is shapable to assume a linear state and to be subsequently formed into a ring-shaped structure.

24. The apparatus according to claim 15, wherein:

the body portion of the annuloplasty ring structure is compressible along a longitudinal axis of the annuloplasty ring structure,

the annuloplasty ring structure comprises a coiled structure having a lumen, and

the contracting member is disposed within the lumen of the coiled structure.