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

• US 10,058,318 B2
• Filed: 04/27/2015
• Issued: 08/28/2018
• 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:
  US14/696,853
• Publication Number:
  US 20150223802A1
• Time in Patent Office: 1,219 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 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 for applying suture clamps, clips or locks A61B2017/0488
• 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 lateral eyelet for attaching suture to needle A61B2017/06019
• 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 hollow suture needles A61B2017/061
• 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 kit, comprising:

a plurality of tissue anchors configured to be at least partially embedded into tissue at respective locations about an orifice within a body during an implant procedure; and

an implant member reconfigurable between a delivery configuration in which the implant member is manipulable to a size and dimension to be deliverable 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 the orifice in the tissue, the implant member comprising;

a plurality of segments;

a number of pivot joints, each pivot joint comprising a respective pivot pin and a respective pivot axis, the pivot pin of each pivot joint arranged to pivotally couple each of the segments together in a respective one of a number of sets of two or more of the segments, at least one segment in each respective one of the number of sets of two or more of the segments pivoting about the respective pivot axis of the pivot joint when the implant member is moved between the delivery configuration and the deployed configuration; and

a plurality of tissue anchor receivers, each tissue anchor receiver comprising at least one alignment surface arranged to contact a portion of a respective one of the plurality of tissue anchors and align the portion of the respective one of the plurality of tissue anchors with respect to an alignment axis of the tissue anchor receiver when the respective one of the plurality of tissue anchors is secured to the implant member, the portion of the respective one of the plurality of tissue anchors impeded from moving along the alignment axis of the tissue anchor receiver to break contact with the at least one alignment surface of the tissue anchor receiver when the respective one of the plurality of tissue anchors is secured to the implant member, wherein the respective alignment axis of at least a first one of the plurality of tissue anchor receivers is non-parallel with the respective pivot axis of at least one of the number of pivot joints, and wherein the respective alignment axis of at least a second one of the plurality of tissue anchor receivers is substantially parallel to the respective pivot axis of the at least one of the number of pivot joints.

2. The implant kit of claim 1 wherein the respective at least one alignment surface of each tissue anchor receiver is arranged to impede the portion of the respective one of the plurality of tissue anchors from moving along a direction having a directional component perpendicular to the respective alignment axis of the tissue anchor receiver when the respective one of the plurality of tissue anchors is secured to the implant member.

3. The implant kit of claim 1 wherein at least one of the plurality of tissue anchors is configured to be embedded in the tissue when the respective portion of the at least one of the plurality of tissue anchors is aligned by the at least one alignment surface of a respective one of the plurality of tissue anchor receivers.

4. The implant kit of claim 1 wherein at least one of the plurality of tissue anchors is configured to be embedded in the tissue when the at least one of the plurality of tissue anchors is secured to the implant member.

5. The implant kit of claim 4, further comprising a number of implant guide lines, each of the number of implant guide lines physically coupled to the at least one of the plurality of tissue anchors when the at least one of the plurality of tissue anchors is configured to be embedded in the tissue to provide a physical path for the implant member to the at least one of the plurality of tissue anchors, the implant member moveable along the physical path to a position where the implant member is secured to the at least one of the plurality of tissue anchors.

6. The implant kit of claim 1 wherein the number of pivot joints comprises a plurality of pivot joints arranged such that the respective pivot axes of at least two of the plurality of pivot joints are parallel with respect to one another.

7. The implant kit of claim 1, further comprising a plurality of biasing devices, each of the biasing devices biasing the segments together in a respective one of the number of sets of two or more of the segments when the plurality of tissue anchors are secured to the implant member.

8. The implant kit of claim 1, further comprising a plurality of couplers, each coupler configured to engage a respective first portion of a respective one of the plurality of tissue anchors to capture a portion of the implant member between the coupler and a respective second portion of the respective one of the plurality of tissue anchors when the respective one of the plurality of tissue anchors is secured to the implant member, the respective second portion of each of the plurality of tissue anchors embeddable into the tissue.

9. The implant kit of claim 1, further comprising a number of holders, each holder activatable between a free configuration in which each segment in a respective one of the number of sets of two or more of the segments is arranged to pivot towards and away from another one of the segments in the respective one of the number of sets of two or more of the segments, and a fixed configuration in which the segment in the respective one of the number of sets of two or more of the segments is impeded from pivoting towards and away from the another one of the segments in the respective one of the number of sets of two or more of the segments with a greater resistance than when the holder is in the free configuration.

10. The implant kit of claim 9 wherein each holder comprises a respective plurality of interlockable elements which are brought into interlocked engagement when the implant member is moved into the deployed configuration.

11. The implant kit of claim 10 wherein each of the plurality of interlockable elements comprises a trapezoidal shaped projection or a trapezoidal shaped recess.

12. The implant kit of claim 1 wherein the respective alignment axis of at least the second one of the plurality of tissue anchor receivers is collinear with the respective pivot axis of the at least one of the number of pivot joints.

13. The implant kit of claim 1 wherein the respective at least one alignment surface of each tissue anchor receiver is arranged to impede the portion of the respective one of the plurality of tissue anchors from moving relative to the tissue anchor receiver along a direction having a directional component perpendicular to the respective alignment axis of the tissue anchor receiver when the respective one of the plurality of tissue anchors is secured to the implant member.

14. An implant kit, comprising:

a plurality of tissue anchors, each of the plurality of tissue anchors at least partially embeddable into tissue at a respective location about an orifice within a body during an implant procedure; and

an implant member reconfigurable between a delivery configuration in which the implant member is manipulable to a size and dimension to be deliverable 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 the orifice in the tissue, the implant member comprising;

a plurality of segments;

a plurality of tissue anchor receivers, each tissue anchor receiver comprising at least one alignment surface arranged to contact a portion of a respective one of the plurality of tissue anchors and position the portion of the respective one of the plurality of tissue anchors at a location where the one of the plurality of tissue anchors is securable to the implant member; and

at least a first pivot joint comprising a first pivot member, the first pivot joint arranged to pivotally couple a first set of two or more of the segments together, at least some of the segments in the first set of two or more of the segments arranged to turn about the first pivot member when the implant member is moved between the delivery configuration and the deployed configuration, the first pivot member and a first one of the tissue anchor receivers provided in a unitary structure to which the first set of two or more of the segments is coupled.

15. The implant kit of claim 14 wherein the first pivot member is fixedly coupled to one of the segments in the first set of two or more of the segments.

16. The implant kit of claim 14 wherein at least one segment in the first set of two or more of the segments is slidably and pivotably coupled to the first pivot member, the at least one segment in the first set of two or more of the segments arranged to translate along, and turn about, the first pivot member when the implant member is moved between the delivery configuration and the deployed configuration.

17. The implant kit of claim 16 wherein the first pivot member comprises at least one obstruction positioned to capture the at least one segment in the first set of two or more of the segments on the first pivot member.

18. The implant kit of claim 14 wherein the respective at least one alignment surface of the first one of the tissue anchor receivers is radially spaced apart from a pivot axis of the first pivot joint by a different radial distance than a surface of the first pivot member contacted by the at least some of the segments in the first set of two or more of the segments.

19. The implant kit of claim 18 wherein the respective at least one alignment surface of the first one of the tissue anchor receivers comprises a tapered surface portion.

20. The implant kit of claim 14 wherein the implant member comprises a plurality of interlockable elements arranged about a pivot axis of the first pivot joint, a first set of the interlockable elements arranged to interlock with a second set of interlockable elements when the implant member is in the deployed configuration.

21. An implant kit, comprising:

a plurality of tissue anchors, each of the plurality of tissue anchors at least partially embeddable into tissue at a respective location about an orifice within a body during an implant procedure; and

an implant member reconfigurable between a delivery configuration in which the implant member is manipulable to a size and dimension to be deliverable 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 the orifice in the tissue, the implant member comprising;

a plurality of rigid portions;

at least one bendable portion arranged to pivotally couple at least one of the rigid portions with at least another of the rigid portions; and

a plurality of tissue anchor receivers, each tissue anchor receiver comprising at least one alignment surface arranged to contact a portion of a respective one of the plurality of tissue anchors and position the portion of the respective one of the plurality of tissue anchors at a location where the one of the plurality of tissue anchors is securable to the implant member, at least a first one of the plurality of tissue anchor receivers located in one of the plurality of rigid portions and at least a second one of the plurality of tissue anchor receivers located in the at least one bendable portion.

22. The implant kit of claim 21 wherein the respective at least one alignment surface of each tissue anchor receiver is arranged to align the portion of the respective one of the plurality of tissue anchors with respect to an alignment axis of the tissue anchor receiver when the respective one of the plurality of tissue anchors is secured to the implant member, the portion of the respective one of the plurality of tissue anchors impeded from moving along the alignment axis of the tissue anchor receiver to break contact with the at least one alignment surface of the tissue anchor receiver when the respective one of the plurality of tissue anchors is secured to the implant member.

23. The implant kit of claim 22 wherein the at least one bendable portion is arranged to pivotally couple the at least one of the rigid portions with the at least another of the rigid portions about a pivot axis when the implant member is moved between the delivery configuration and the deployed configuration, wherein the respective alignment axis of at least the first one of the plurality of tissue anchor receivers located in the one of the plurality of rigid portions is non-parallel with the pivot axis, and wherein the respective alignment axis of at least the second one of the plurality of tissue anchor receivers located in the at least one bendable portion is substantially parallel to the pivot axis.

24. The implant kit of claim 23

wherein the pivot axis is a first pivot axis,

wherein at least the first one of the plurality of tissue anchor receivers is located in the one of the rigid portions and at least the second one of the plurality of tissue anchor receivers is located in the at least one bendable portion,

wherein the implant kit further comprises at least a second bendable portion arranged to pivotally couple at least the another of the rigid portions with at least a third rigid portion of the plurality of rigid portions about a second pivot axis when the implant member is moved between the delivery configuration and the deployed configuration, and

wherein the first pivot axis is parallel to the second pivot axis.

25. The implant kit of claim 23 wherein the respective alignment axis of at least the second one of the plurality of tissue anchor receivers is collinear with the respective pivot axis.

26. The implant kit of claim 22 wherein the respective at least one alignment surface of each tissue anchor receiver is arranged to impede the portion of the respective one of the plurality of tissue anchors from moving along a direction having a directional component perpendicular to the respective alignment axis of the tissue anchor receiver when the respective one of the plurality of tissue anchors is secured to the implant member.

27. The implant kit of claim 22 wherein the respective at least one alignment surface of each tissue anchor receiver is arranged to impede the portion of the respective one of the plurality of tissue anchors from moving relative to the respective one of the plurality of tissue anchors along a direction having a directional component perpendicular to the respective alignment axis of the tissue anchor receiver when the respective one of the plurality of tissue anchors is secured to the implant member.

28. The implant kit of claim 21 wherein at least one of the plurality of tissue anchors is configured to be embedded in the tissue when the respective portion of the at least one of the plurality of tissue anchors is aligned by the at least one alignment surface of a respective one of the plurality of tissue anchor receivers.

29. The implant kit of claim 21 wherein at least one of the plurality of tissue anchors is configured to be embedded in the tissue when the at least one of the plurality of tissue anchors is secured to the implant member.

30. The implant kit of claim 29, further comprising a number of implant guide lines, each of the number of implant guide lines physically coupled to the at least one of the plurality of tissue anchors when the at least one of the plurality of tissue anchors is configured to be embedded in the tissue to provide a physical path for the implant member to the at least one of the plurality of tissue anchors, the implant member moveable along the physical path to a position where the implant member is secured to the at least one of the plurality of tissue anchors.

31. The implant kit of claim 21, further comprising a plurality of biasing devices, each of the biasing devices biasing the rigid portions together in a respective one of a number of sets of two or more of the rigid portions of the plurality of rigid portions when the plurality of tissue anchors are secured to the implant member.

32. The implant kit of claim 21, further comprising a plurality of couplers, each coupler configured to engage a respective first portion of a respective one of the plurality of tissue anchors to capture a portion of the implant member between the coupler and a respective second portion of the respective one of the plurality of tissue anchors when the respective one of the plurality of tissue anchors is secured to the implant member, the respective second portion of each of the plurality of tissue anchors embeddable into the tissue.

33. The implant kit of claim 21, further comprising a number of holders, each holder activatable between a free configuration in which each rigid portion in a respective one of a number of sets of two or more of the rigid portions of the plurality of rigid portions is arranged to pivot towards and away from a second one of the rigid portions in the respective one of the number of sets of two or more of the rigid portions, and a fixed configuration in which the rigid portion in the respective one of the number of sets of two or more of the rigid portions is impeded from pivoting towards and away from the second one of the rigid portions in the respective one of the number of sets of two or more of the rigid portions with a greater resistance than when the holder is in the free configuration.

34. The implant kit of claim 33 wherein each holder comprises a respective plurality of interlockable elements which are brought into interlocked engagement when the implant member is moved into the deployed configuration.

35. The implant kit of claim 34 wherein each of the plurality of interlockable elements comprises a trapezoidal shaped projection or a trapezoidal shaped recess.

36. An implant kit, comprising:

a plurality of tissue anchors, each of the plurality of tissue anchors at least partially embeddable into tissue at a respective location about an orifice within a body during an implant procedure; and

an implant member reconfigurable between a delivery configuration in which the implant member is manipulable to a size and dimension to be deliverable 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 the orifice in the tissue, the implant member comprising;

a plurality of segments;

a plurality of tissue anchor receivers, each tissue anchor receiver comprising at least one alignment surface arranged to contact a portion of a respective one of the plurality of tissue anchors and position the portion of the respective one of the plurality of tissue anchors at a location where the one of the plurality of tissue anchors is securable to the implant member; and

at least a first pivot joint comprising a first pivot member, the first pivot joint arranged to pivotally couple a first set of two or more of the segments together, at least some of the segments in the first set of two or more of the segments arranged to turn about the first pivot member when the implant member is moved between the delivery configuration and the deployed configuration, the first pivot member and a first one of the tissue anchor receivers provided in a unitary structure,

wherein at least one segment in the first set of two or more of the segments is slidably and pivotably coupled to the first pivot member, the at least one segment in the first set of two or more of the segments arranged to translate along, and turn about, the first pivot member when the implant member is moved between the delivery configuration and the deployed configuration.