Implantation of repair devices in the heart

• US 10,357,366 B2
• Filed: 05/18/2018
• Issued: 07/23/2019
• Est. Priority Date: 12/05/2006
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Gross, Amir, Beinart, Iftah, Miller, Eran, Cabiri, Oz, Eliachar, Eliahu, Lilach, Nir, Grossfeld, Ram, Golom, Dmitry, Meyer-Brodnitz, Gideon, Mosaiuf, Arnon
• Primary Examiner(s): Schall, Matthew W
• Application Number:
  US15/983,569
• Publication Number:
  US 20180263777A1
• Time in Patent Office: 431 Days
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 2017/00407 Ratchet means
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• 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 2/2466 Delivery devices therefor

Abstract

Apparatuses and devices usable for annuloplasty are provided. These can include a plurality of helical tissue anchors and an annuloplasty structure for placement on a heart valve annulus. The annuloplasty structure can include a plurality of compressible or adjustable subunits, and a plurality of anchor mounts alternately disposed with respect to the plurality of compressible/adjustable subunits. The anchor mounts are coupleable to the helical anchors and can define a path for passage therethrough of a respective helical tissue anchor. The apparatuses and devices can be independently adjustable and can be adjustable for treating various sizes of patient annuli. Other embodiments are also described.

Claims

1. A method, comprising:

obtaining;

a plurality of helical tissue anchors; and

an annuloplasty structure for placement on an annulus of a heart valve, the annuloplasty structure comprising;

a plurality of compressible subunits, and

a plurality of anchor mounts alternately disposed with respect to the plurality of compressible subunits, each anchor mount defining a path for passage of a respective one of the plurality of helical tissue anchors; and

anchoring the annuloplasty structure to a native annulus of a native heart valve with the plurality of helical tissue anchors each passing through a respective path of the plurality of anchor mounts; and

transitioning the annuloplasty structure from a first configuration having a first diameter to a second configuration having a second diameter different from the first diameter.

2. The method according to claim 1, wherein anchoring further comprises advancing each of the plurality of helical tissue anchors to a point where they are restricted from continued advancement into tissue of the annulus.

3. The method according to claim 1, further comprising contracting the annuloplasty structure by pulling a portion of a contracting wire coupled to the annuloplasty structure.

4. The method according to claim 1, further comprising maintaining a perimeter of the annuloplasty structure following the contracting, using a ratchet coupled to the annuloplasty structure.

5. The method according to claim 1, wherein the anchor mount comprises first and second openings, and wherein anchoring the annuloplasty structure to the native annulus of the native heart valve comprises moving the respective one of the plurality of helical tissue anchors through the first and second openings and into tissue of the annulus.

6. The method according to claim 5, wherein moving the respective one of the plurality of helical tissue anchors through the first and second openings comprises corkscrewing the distal portion of the respective one of the plurality of helical tissue anchors around a structural element before moving the distal portion through the second opening.

7. The method according to claim 6, wherein the structural element comprises a bar that is disposed in parallel with a plane of the annuloplasty structure, the plane including a portion of each of the plurality of anchor mounts.

8. The method according to claim 1, wherein the annuloplasty structure is coupled to a first ring and a second ring, and wherein the method further comprises:

rotating the first ring about its axis of rotation to contract the annuloplasty structure while the second ring remains rotationally stationary about its axis of rotation; and

rotating the second ring about its axis of rotation to contract the annuloplasty structure while the first ring remains rotationally stationary about its axis of rotation.

9. The method according to claim 1, wherein the path of a first anchor mount of the plurality of anchor mounts is non-parallel relative to the path of a second anchor mount of the plurality of anchor mounts.

10. The method according to claim 1, wherein transitioning the annuloplasty structure comprises rotating a ring coupled to the annuloplasty structure to contract the annuloplasty structure.

11. The method according to claim 10, further comprising using a lock ring to lock the rotatable ring.

12. The method according to claim 1, wherein the second diameter is smaller than the first diameter.

13. The method according to claim 1, wherein the plurality of compressible subunits comprise struts.

14. The method according to claim 1, further comprising using a ratchet coupled to the annuloplasty structure to maintain a perimeter of the annuloplasty structure after transitioning the annuloplasty structure from the first configuration to the second configuration.

15. A method comprising:

obtaining an annuloplasty system comprising;

a plurality of helical tissue anchors; and

an annuloplasty structure for placement on an annulus of a heart valve, the annuloplasty structure comprising;

a plurality of compressible subunits comprising struts, and

a plurality of anchor mounts alternately disposed with respect to the plurality of compressible subunits, each anchor mount defining a path for passage of a respective helical tissue anchor of the plurality of helical tissue anchors; and

anchoring the annuloplasty structure to a native annulus of a native heart valve with the plurality of helical tissue anchors each passing along a respective path of the plurality of anchor mounts; and

transitioning the annuloplasty structure from a larger configuration to a smaller configuration to reduce a size of the native annulus of the native heart valve.

16. The method according to claim 15, wherein each of the plurality of compressible subunits is independently adjustable from an expanded configuration to a contracted configuration, and wherein transitioning the annuloplasty structure from a larger configuration to a smaller configuration comprises adjusting at least one of the plurality of compressible subunits from the expanded configuration to the contracted configuration.

17. A method for reducing a size dimension of a native annulus of a native heart valve, comprising:

obtaining an annuloplasty system comprising;

an annuloplasty structure comprising a plurality of adjustable subunits and a plurality of anchor mounts alternately disposed with respect to the plurality of adjustable subunits;

a first ring rotatable about an axis of rotation of the first ring; and

a second ring rotatable about an axis of rotation of the second ring;

attaching the annuloplasty structure to the native annulus of the native heart valve;

rotating the first ring about the axis of rotation of the first ring to contract at least a portion of the annuloplasty structure while the second ring remains rotationally stationary about the axis of rotation of the second ring; and

rotating the second ring about the axis of rotation of the second ring to contract at least a portion of the annuloplasty structure while the first ring remains rotationally stationary about the axis of rotation of the first ring.

18. The method according to claim 17, wherein attaching the annuloplasty device to the native annulus of the native heart valve comprises using a respective helical tissue anchor in each of respective ones of the plurality of anchor mounts to attach the plurality of anchor mounts to tissue of the native annulus.

19. A method for reshaping a native annulus of a native heart valve, comprising:

obtaining an annuloplasty device having a plurality of adjustable segments and a plurality of anchor mounts alternately disposed with respect to the plurality of adjustable segments, wherein the annuloplasty device is adjustable such that it can be used to treat a variety of different sizes of annuli of different patients, and wherein a first segment of the annuloplasty device is adjustable independently of a second segment of the annuloplasty device;

anchoring the annuloplasty device to the native annulus of the native heart valve with a plurality of tissue anchors coupled to the plurality of anchor mounts and inserted into tissue of the native annulus; and

adjusting the first segment of the annuloplasty device independently of the second segment of the annuloplasty device.

20. The method according to claim 19, further comprising adjusting the second segment of the annuloplasty device independently of the first segment of the annuloplasty device.