Medical kit for constricting tissue or a bodily orifice, for example, a mitral valve

• US 9,072,511 B2
• Filed: 03/15/2012
• Issued: 07/07/2015
• Est. Priority Date: 03/25/2011
• Status: Active Grant

• Current Assignee: Kardium Inc.
• Original Assignee: Kardium Inc.
• Inventors: Tegzes, Aleksandar
• Primary Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US13/421,677
• Publication Number:
  US 20120245604A1
• Time in Patent Office: 1,209 Days
• Field of Search: 623 236- 239, 403/73, 403/104, 403/105, 403/107
• 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 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• 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 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

A device, kit and method may include or employ an implantable device (e.g., annuloplasty implant) and a plurality of tissue anchors. The implantable device is positionable in a cavity of a bodily organ (e.g., a heart) and operable to constrict a bodily orifice (e.g., a mitral valve). Each of the tissue anchors may be guided into precise position by an intravascularly or percutaneously techniques. Constriction of the orifice may be accomplished via a variety of structures, for example an articulated annuloplasty ring, the ring attached to the tissue anchors. The annuloplasty ring may be delivered in an unanchored, generally elongated configuration, and implanted in an anchored generally arched, arcuate or annular configuration. Such may approximate the septal and lateral (clinically referred to as anterior and posterior) annulus of the mitral valve, to move the posterior leaflet anteriorly and the anterior leaflet posteriorly, thereby improving leaflet coaptation to reduce mitral regurgitation.

Claims

1. An implant, comprising:

an implant member reconfigurable between a delivery configuration in which the implant member is manipulable to a size and dimension to be delivered percutaneously to the tissue within the body, and a deployed configuration in which the implant member forms a structure sufficiently rigid to affect a shape of an orifice in the tissue, the implant member comprising;

a plurality of segments;

a pivot joint comprising a pivot axis, the pivot joint arranged to pivotally couple two segments of the plurality of segments together; and

a holder activatable between a free configuration in which the two segments are arranged to pivot towards and away from each other about the pivot axis, and a fixed configuration in which the two segments are impeded from pivoting towards and away from each other about the pivot axis with a greater resistance than when the holder is in the free configuration, the holder comprising a plurality of interlockable elements positioned in interlocked engagement when the holder is in the fixed configuration, wherein a first one of the two segments is impeded with a first resistance from pivoting about the pivot axis along a first rotational direction towards a second one of the two segments when the holder is in the fixed configuration, and the first one of the two segments is impeded with a second resistance from pivoting about the pivot axis along a second rotational direction away from the second one of the two segments when the holder is in the fixed configuration, wherein the second rotational direction is opposite to the first rotational direction, each of the first resistance and the second resistance is provided at least in part by the holder, and a magnitude of the second resistance is less than a magnitude of the first resistance.

2. The implant of claim 1 wherein the plurality of interlockable elements comprise a first set of the interlockable elements having a plurality of projections and a plurality of recesses, and a second set of the interlockable elements having a plurality of projections and a plurality of recesses, each of the projections in each of the first and the second sets of the interlockable elements sized and dimensioned to be received by a respective one of the recesses in the other of the first and the second sets of the interlockable elements when the first set of the interlockable elements is moved relatively closer to the second set of the interlockable elements along a direction having a directional component parallel to a direction that the pivot axis extends along.

3. The implant of claim 2 wherein each of the projections and recesses in the first set of the interlockable elements and the first one of the two segments are provided in a first unitary structure, and wherein each of the projections and recesses in the second set of the interlockable elements and the second one of the two segments are provided in a second unitary structure.

4. The implant of claim 1 wherein the plurality of interlockable elements comprise a first set of the interlockable elements having a plurality of projections and a plurality of recesses and a second set of the interlockable elements having a plurality of projections and a plurality of recesses, each of the projections in each of the first and the second sets of the interlockable elements sized and dimensioned to be received by a respective one of the recesses in the other of the first and the second sets of the interlockable elements when the plurality of interlockable elements are moved into interlocked engagement, each of the projections and recesses in each of the first and the second sets of the interlockable elements radially arranged about the pivot axis.

5. The implant of claim 4 wherein the plurality of interlockable elements are moved into interlocked engagement when a portion of the first one of the two segments is moved relatively with respect to a portion of the second one of two segments along an axis that is substantially parallel to the pivot axis.

6. The implant of claim 4, wherein the pivot joint comprises a pivot member, and the plurality of interlockable elements are moved into interlocked engagement when at least one of the two segments is moved axially along the pivot member to reduce a distance between the two segments.

7. The implant of claim 6 wherein the first one of the two segments is axially positioned along the pivot member relatively closer to the second one of the two segments on the pivot member when the implant member is in the deployed configuration, and the first one of the two segments is axially positioned along the pivot member relatively farther from the second one of two segments when the implant member is in the delivery configuration.

8. The implant of claim 7, further comprising a biasing device arranged to apply a force to bias the two segments together when the implant member is in the deployed configuration, the force applied along a direction having a directional component parallel to a direction that the pivot axis extends along.

9. The implant of claim 8, further comprising a plurality of tissue anchors, each of the plurality of tissue anchors at least partially embeddable in tissue at a respective location about an orifice within a body during an implant procedure.

10. The implant of claim 9 wherein the implant member comprises a tissue anchor receiver configured to receive a portion of a first one of the plurality of tissue anchors.

11. The implant of claim 8, further comprising a coupler arranged to secure the first one of the plurality of tissue anchors to the implant member, at least the coupler and the biasing device provided in a unitary structure.

12. The implant of claim 1 wherein the plurality of interlockable elements comprise a first set of the interlockable elements having a plurality of projections and a plurality of recesses, and a second set of the interlockable elements having a plurality of projections and a plurality of recesses, each of the projections in each of the first and the second sets of the interlockable elements receivable by a respective one of the recesses in the other of the first and the second sets of the interlockable elements, at least some of the projections in at least one of the first and the second sets of the interlockable elements shaped and sized for wedged engagement with at least some of the recesses in the other of the first and the second sets of the interlockable elements when the at least one of the first and the second sets of the interlockable elements is moved relatively closer to the other of the first and the second sets of the interlockable elements along a direction having a first directional component parallel to a direction that the pivot axis extends along.

13. The implant of claim 12 wherein at least one projection in the at least one of the first and the second sets of the interlockable elements comprises a respective pair of non-parallel opposing surfaces positioned to be wedged between two opposing surfaces of a respective one of the recesses in the other of the first and the second sets of the interlockable elements when the at least one of the first and the second sets of the interlockable elements is moved relatively closer to the other of the first and the second sets of the interlockable elements along the direction having the first directional component, a first surface of the respective pair of non-parallel opposing surfaces oriented with respect to the first directional component by a greater angular amount than a second surface of the respective pair of non-parallel opposing surfaces.

14. The implant of claim 13 wherein the second surface of the respective pair of non-parallel opposing surfaces is oriented substantially parallel to the first directional component.

15. The implant of claim 13 wherein the plurality of interlockable elements are brought into wedged engagement when a portion of the first one of the two segments is moved relatively closer to a portion of the second one of two segments along an axis that is substantially parallel to the pivot axis.

16. The implant of claim 15 wherein the portion of the first one of the two segments is positioned relatively closer to the portion of the second one of the two segments along the axis that is substantially parallel to the pivot axis when the implant member is in the deployed configuration than when the implant member is in the delivery configuration.

17. The implant of claim 12 wherein the plurality of interlockable elements are arranged within the holder to interlock with one another when the implant member is moved into the deployed configuration.

18. The implant of claim 12 wherein at least one recess in the at least one of the first and the second sets of the interlockable elements comprises a respective pair of non-parallel opposing surfaces positioned to be wedged against two opposing surfaces of a respective one of the projections in the other of the first and the second sets of the interlockable elements when the at least one of the first and the second sets of the interlockable elements is moved relatively closer to the other of the first and the second sets of the interlockable elements along the direction having the first directional component, a first surface of the respective pair of non-parallel opposing surfaces oriented with respect to the first directional component by a greater angular amount than a second surface of the respective pair of non-parallel opposing surfaces.

19. The implant of claim 1 wherein, in the free configuration, a height of the two segments at the pivot joint exceeds a height of the two segments at the pivot joint in the fixed configuration.

20. The implant of claim 1 wherein, at the pivot joint, in the free configuration, a first portion of the first one of the two segments is spaced apart from a second portion of the second one of the two segments, and, in the fixed configuration, the first portion of the first one of the two segments contacts the second portion of the second one of the two segments.

21. The implant of claim 1 wherein, at the pivot joint, an axial separation between the two segments in the free configuration is less than the axial separation between the two segments in the fixed configuration.

22. The implant of claim 21 wherein the axial separation is along a direction substantially perpendicular to a length-wise direction of the implant member.

23. The implant of claim 1 wherein the plurality of interlockable elements comprise a first set of the interlockable elements having a plurality of projections and a plurality of recesses, and a second set of the interlockable elements having a plurality of projections and a plurality of recesses, at least one projection in at least one of the first and the second sets of the interlockable elements comprises a respective pair of non-parallel opposing surfaces connected together by a third surface that is non-parallel to the respective pair of non-parallel opposing surfaces.

24. The implant of claim 1, further comprising:

a biasing device; and

a tissue anchor coupled to the biasing device, the tissue anchor extending through the pivot joint.

25. The implant of claim 24 wherein the tissue anchor is directly coupled to the biasing device with an end portion of the tissue anchor penetrating the biasing device.

26. The implant of claim 24 wherein the holder is disposed between the biasing device and a portion of the tissue anchor configured to be embedded in tissue when the implant member is in the deployed configuration.