Apparatus and method for guide-wire based advancement of an adjustable implant

• US 9,180,007 B2
• Filed: 12/06/2012
• Issued: 11/10/2015
• Est. Priority Date: 10/29/2009
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Reich, Tal, Miller, Eran, Sheps, Tal
• Primary Examiner(s): Shi, Katherine M
• Application Number:
  US13/707,013
• Publication Number:
  US 20130096672A1
• Time in Patent Office: 1,069 Days
• Field of Search: 623/2.1, 623/2.11, 623/2.36, 623/2.37
• US Class Current: 1/1
• 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 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0448 Additional elements on or within the anchor
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2250/0007 for adjusting length

Abstract

Apparatus is provided, comprising (1) a guide member, (2) a tissue-adjustment mechanism having (a) an upper surface and a lower surface, (b) at least one first opening at the upper surface, (c) at least one second opening at the lower surface, and (4) a channel extending between the first and second openings, the channel facilitating advancement of the tissue-adjustment mechanism along the guide member; and (3) at least one repair chord coupled at a first portion thereof to the tissue-adjustment mechanism and having at least a first end that is configured to be coupled to a portion of tissue of a patient, the repair chord being configured to adjust a distance between the portion of tissue and the tissue-adjustment mechanism, in response to adjustment of the repair chord by the tissue-adjustment mechanism. Other embodiments are also described.

Claims

1. Apparatus for use with tissue of a heart of a subject, the apparatus comprising:

at least one docking assembly, having;

a distal portion comprising a tissue anchor that is configured to engage a portion of the tissue,

a proximal portion, fixedly coupled to the distal portion, and comprising at least one docking station that comprises a first coupling;

at least one guide member, reversibly coupled to the at least one docking station; and

an annuloplasty ring selected from the group consisting of;

a partial annuloplasty ring and a full annuloplasty ring, the selected annuloplasty ring;

comprising a second coupling,

being slidable along the guide member toward the docking station, and

configured to be locked to the docking station by the second coupling being locked to the first coupling.

2. The apparatus according to claim 1, wherein the second coupling is lockable to the first coupling by being pushed against the first coupling.

3. The apparatus according to claim 1, wherein the annuloplasty ring is configured to be locked to the docking station sutureles sly.

4. The apparatus according to claim 1, wherein the docking assembly is percutaneously deliverable to the heart of the subject, and the annuloplasty ring is percutaneously lockable to the docking station.

5. The apparatus according to claim 1, wherein:

the at least one docking assembly comprises a plurality of docking assemblies,

the at least one guide member comprises a respective plurality of guide members, each of the guide members being reversibly coupled to a respective docking station of a respective docking assembly,

the selected annuloplasty ring comprises a respective plurality of second couplings, and is slidable along the plurality of guide members toward the plurality of docking assemblies, and

each of the second couplings is lockable to a respective first coupling of a respective docking station.

6. The apparatus according to claim 1, wherein the selected annuloplasty ring comprises an adjustable annuloplasty ring, comprising a rotatable structure that is:

bidirectionally rotatable to adjust the selected annuloplasty ring,

shaped to define a channel between an upper surface thereof and a lower surface thereof, the guide member being disposable in the channel, and

shaped to define the second coupling, and

wherein the selected annuloplasty ring is slidable along the guide member by the rotatable structure being slidable along the guide member.

7. The apparatus according to claim 6, wherein:

the selected annuloplasty ring comprises;

a sleeve, having a longitudinal length from a first end thereof to a second end thereof, and defining lumen therebetween; and

a flexible longitudinal member, at least part of which is disposed in at least part of the lumen, and

the rotatable structure is;

coupled to a first end portion of the flexible longitudinal member, and

bidirectionally rotatable to adjust the longitudinal length of the sleeve by adjusting a degree of tension of the flexible longitudinal member.

8. The apparatus according to claim 7, further comprising a rotatable structure locking mechanism displaceable with respect to the rotatable structure, so as to release the rotatable structure during rotation of the rotatable structure, and lock in place the rotatable structure following rotation of the rotatable structure.

9. The apparatus according to claim 8, further comprising a release rod:

shaped to define a lumen therethrough, the guide member being disposable within the lumen of the release rod, and

configured to unlock the rotatable structure locking mechanism by being slid over the guide member.

10. The apparatus according to claim 1, wherein the at least one docking station is configured to be coupled to the selected annuloplasty ring such that the at least one docking station is disposed between the selected annuloplasty ring and the tissue anchor.

11. Apparatus for use with tissue of a body of a subject, the apparatus comprising:

a docking assembly, having;

a distal portion comprising a tissue anchor that is configured to engage a portion of the tissue,

a proximal portion, fixedly coupled to the distal portion, and comprising at least one docking station shaped to define a first coupling;

at least one guide member, reversibly coupled to the at least one docking station; and

an adjustable implant comprising an adjustment mechanism, the adjustment mechanism being;

advanceable into the body separately from the docking assembly,

actuatable to adjust a dimension of the implant while the implant is disposed within the body,

shaped to define a second coupling,

shaped to define a channel through which the guide member is slidable, such that the adjustment mechanism is slidable over the guide member toward the docking station, and

intracorporeally lockable to the docking station by the second coupling being locked to the first coupling.

12. The apparatus according to claim 11, wherein the adjustable implant comprises an adjustable annuloplasty ring selected from the group consisting of:

a partial annuloplasty ring and a full annuloplasty ring.

13. The apparatus according to claim 12, wherein the adjustment mechanism is intracorporeally lockable to the docking station such that the docking station is disposed between the adjustable implant and the tissue anchor.

14. Apparatus for use with tissue of a heart of a subject, the apparatus comprising:

at least one docking assembly, having;

a distal portion comprising a tissue anchor that is configured to engage a portion of the tissue,

a proximal portion, fixedly coupled to the distal portion, and comprising at least one docking station that comprises a first coupling;

at least one guide member, reversibly attached to the at least one docking station; and

an annuloplasty ring selected from the group consisting of;

a partial annuloplasty ring and a full annuloplasty ring, the selected annuloplasty ring being;

shaped to define a second coupling,

slidable along the guide member toward the docking station, and

configured to be locked to the docking station by the second coupling being locked to the first coupling.

15. The apparatus according to claim 14, wherein the second coupling is lockable to the first coupling by being pushed against the first coupling.

16. The apparatus according to claim 14, wherein the annuloplasty ring is configured to be locked to the docking station sutureles sly.

17. The apparatus according to claim 14, wherein the docking assembly is percutaneously deliverable to the heart of the subject, and the annuloplasty ring is percutaneously lockable to the docking station.

18. The apparatus according to claim 14, wherein:

the at least one docking assembly comprises a plurality of docking assemblies,

the at least one guide member comprises a respective plurality of guide members, each of the guide members being reversibly attached to a respective docking station of a respective docking assembly,

the selected annuloplasty ring is shaped to define a respective plurality of second couplings, and is slidable along the plurality of guide members toward the plurality of docking assemblies, and

each of the second couplings is lockable to a respective first coupling of a respective docking station.

19. The apparatus according to claim 14, wherein the selected annuloplasty ring comprises an adjustable annuloplasty ring, comprising a rotatable structure that is:

bidirectionally rotatable to adjust the selected annuloplasty ring,

shaped to define a channel between an upper surface thereof and a lower surface thereof, the guide member being disposable in the channel, and

shaped to define the second coupling, and

wherein the selected annuloplasty ring is slidable along the guide member by the rotatable structure being slidable along the guide member.

20. The apparatus according to claim 14, wherein the at least one docking station is configured to be coupled to the selected annuloplasty ring such that the at least one docking station is disposed between the selected annuloplasty ring and the tissue anchor.