MEDICAL DEVICE, KIT AND METHOD FOR CONSTRICTING TISSUE OR A BODILY ORIFICE, FOR EXAMPLE, A MITRAL VALVE

• US 20110082538A1
• Filed: 09/30/2010
• Published: 04/07/2011
• Est. Priority Date: 10/01/2009
• Status: Abandoned Application

• Current Assignee: Kardium Inc.
• Original Assignee: Kardium Inc.
• Inventors: Dahlgren, Jonathan, Watkinson, Kelly, Goertzen, Douglas, To, Derrick, Gelbart, Daniel
• Application Number:
  US12/894,912
• Publication Number:
  US 20110082538A1
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00411 actuated by application of energy from an energy source outside the body
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/045 snug fit within the anchor
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/22038 with a guide wire
• 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 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

A device, kit and method may include or employ an implantable device (e.g., annuloplasty implant) and a tool operable to implant such. 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). The tissue anchors may be guided into precise position by an intravascularly or percutaneously deployed anchor guide frame of the tool and embedded in an annulus of the orifice. Constriction of the orifice may be accomplished via a variety of structures, for example by cinching a flexible cable or via a anchored annuloplasty ring, the cable or ring attached to the tissue anchors. The annuloplasty ring may be delivered in an unanchored, generally elongated configuration, and implanted in an anchored generally arch, 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 eliminate mitral regurgitation.

Claims

1. An implant kit comprising:

a plurality of tissue anchors comprising at least a first tissue anchor, a second tissue anchor and a third tissue anchor;

a percutaneous delivery system operable to at least partially embed each of the tissue anchors into a respective location about a periphery of an orifice in a tissue within a body during an implant procedure in which a location of the embedded third tissue anchor is laterally offset by a first distance from a first axis, the first axis extending between a location of the embedded first tissue anchor and a location of the embedded second tissue anchor;

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 an implantable configuration in which the implantable member forms a structure sufficiently rigid to affect a shape of the orifice in the tissue, the implant member further comprising a plurality of tissue anchor receivers, each of the tissue anchor receivers positioned to physically couple with a respective one of the embedded tissue anchors, the plurality of tissue anchor receivers comprising at least a first tissue anchor receiver corresponding to the first tissue anchor, a second tissue anchor receiver corresponding to the second tissue anchor, and a third tissue anchor receiver corresponding to the third tissue anchor, wherein a location of the third tissue anchor receiver on the implant member in the implantable configuration is laterally offset by a second distance from a second axis, the second axis extending between a location of the first tissue anchor receiver on the implant member and a location of the second tissue anchor receiver on the implant member, wherein the second distance is smaller than the first distance; and

a plurality of implant guide lines that in use during the implant procedure provide a physical path for the implant member to the embedded tissue anchors.

2. The implant kit of claim 1 wherein the implant member comprises a plurality of segments physically coupled to one another, the segments being articuable with respect to one another as the implant member is moved between the deliverable configuration and the implantable configuration.

3. The implant kit of claim 2 wherein the implant member comprises a number of hinges that physically couple each of the segments to at least one other of the segments.

4. The implant kit of the claim 3 wherein the implant member comprises a number of stops configured to increase a torsional stiffness of each of the hinges when each of the segments pivots by a defined amount with respect to another of the segments.

5. The implant kit of claim 2 wherein the implant member comprises a number of flexure joints that physically couple each of the segments to at least one other of the segments.

6. The implant kit of claim 5 wherein the implant member comprises a number of stops configured to increase a bending stiffness of each of the flexure joints when each of the segments flexes by a defined amount with respect to another of the segments.

7. The implant kit of claim 2 wherein the implant member comprises a number of stops configured to restrain articulation between the coupled segments.

8. The implant kit of claim 1 wherein each of the tissue anchors comprises at least one barb.

9. The implant kit of claim 1 wherein each of the tissue anchors is a helical tissue anchor.

10. The implant kit of claim 1 wherein each of the tissue anchors is a grapple tissue anchor, each grapple tissue anchor comprising at least two prongs pivotally coupled to each other, and each of the two prongs having a tip shaped to pierce the tissue.

11. The implant kit of claim 1 wherein the implant member has at least three guide line receivers that each ride on respective ones of the guide lines, wherein a circumference defined by a circle passing through at least three locations of the at least three guide line receivers on the implant member in the implantable configuration is smaller than a circumference defined by a circle passing through the respective locations of the embedded first, second and third tissue anchors prior to a physical coupling between each of the embedded first, second and third tissue anchors and respective ones of the first, second and third tissue anchor receivers.

12. An implant kit, comprising:

an implant member configured to affect a shape of an orifice in tissue within a body during an implant procedure, a portion of the implant member having a variable bending stiffness in at least one dimensional plane, the implant member comprising a first end, a second end and a plurality of guide line receivers positioned between the first end and the second end along the implant member, the implant member configured to be bendable between a first configuration in which implant member has an elongated shape and a second configuration in which the implant has an arcuate shape, the first end being spaced apart from the second end by a greater distance when the implant member is in the first configuration than when the implant member is in the second configuration, and the portion of the implant member having a reduced bending stiffness in the at least one dimensional plane when the implant member is in first configuration and an increased bending stiffness in the at least one dimensional plane when the implant member is in the second configuration;

a plurality of tissue anchors configured to be at least partially embedded into tissue at respective locations about the orifice in the tissue within the body; and

a plurality of guide lines, each of the guide lines sized to be received by a respective one of the guide line receivers and a respective one of the tissue anchors, each of at least one of the guide lines being configured to receive a tensile force sufficient to move a portion of the tissue into which a respective tissue anchor is embedded towards the implant member in the second configuration.

13. The implant kit of claim 12, the implant member comprising a plurality of tissue anchor receivers positioned along the implant member between the first end and the second end, each of the tissue anchor receivers configured to physically receive a respective one of the tissue anchors, and wherein each of the at least one of the guide lines is configured to receive a tensile force sufficient to move the portion of the tissue to a position where the respective tissue anchor embedded into the portion of the tissue is physically received by a respective tissue anchor receiver when the implant member in the second configuration.

14. The implant kit of claim 13 wherein the implant member comprises a plurality of segments physically coupled to one another, the segments being articuable with respect to one another to provide the reduced bending stiffness in the at least one dimensional plane when the implant member is in the first configuration.

15. The implant kit of claim 14 wherein the implant member comprises a number of hinges that physically couple each of the segments to at least one other of the segments.

16. The implant kit of the claim 15 wherein the implant member comprises a number of stops configured to increase a torsional stiffness of each of the hinges when each of the segments pivots by a defined amount with respect to another of the segments to provide the increased bending stiffness in the at least one dimensional plane when the implant member is in the second configuration.

17. The implant kit of claim 14 wherein the implant member comprises a number of flexure joints that physically couple each of the segments to at least one other of the segments.

18. The implant kit of claim 17 wherein the implant member comprises a number of stops configured to provide the increased bending stiffness in the at least one dimensional plane when the implant member is in the second configuration.

19. The implant kit of claim 14 wherein the implant member comprises a number of stops configured to restrain articulation between the coupled segments to provide the increased bending stiffness in the at least one dimensional plane when the implant member is in the second configuration.

20. The implant kit of claim 19 wherein the embedded tissue anchors apply tension to implant member in the second configuration when each of the tissue anchor receivers is coupled with a respective one of the embedded tissue anchors.

21. The implant kit of claim 20 wherein the applied tension is sufficient to restrain disengagement of each of the coupled segments with an associated one of the stops.

22. The implant kit of claim 20 wherein the applied tension is sufficient to flex at least one of segments while each of the at least one of the segments is engaged with an associated one of the stops.

23. The implant kit of claim 13 wherein each of the tissue anchors comprises at least one piercing element configured for piercing the tissue.

24. The implant kit of claim 13 wherein each of the tissue anchors is a helical tissue anchor.

25. The implant kit of claim 13 wherein each of the tissue anchors is a grapple tissue anchor, each grapple tissue anchor comprising at least two prongs pivotally coupled to each other, and each of the two prongs having a tip shaped to pierce the tissue.

26. The implant kit of claim 13 wherein the plurality of guide line receivers comprise at least three guide line receivers, a circumference defined by a circle passing through at least three locations of the at least three guide line receivers on the implant member in the second configuration being smaller than a circumference defined by a circle passing through at least three locations of their respective embedded tissue anchors about the orifice in the tissue prior to a physical coupling between any of the tissue anchor receivers and their respective embedded tissue anchors.

27. The implant kit of claim 13 wherein the implant member in the first configuration is manipulable to a size and dimension to be deliverable via a catheter.

28. The implant kit of claim 13, wherein the portion of the implant member has a substantially equal bending stiffness in each of a plurality of directions in the at least one dimensional plane when the implant member is in the first configuration and the portion of the implant member has a substantially unequally bending stiffness in each of the plurality of directions in the at least one dimensional plane when the implant member is in the second configuration.

29. An implant kit, comprising:

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

an implant member having a plurality of segments physically coupled to one another, in a delivery configuration the segments being articulable with respect to one another by a respective articulation joint such that the implant member is manipulable to a size and dimension to be deliverable via a catheter and in an deployed configuration the segments form a structure sufficiently rigid to affect a shape of the orifice in the tissue when the implant member is positioned to physically couple with the embedded tissue anchors; and

a plurality of implant guide lines that in use during the implant procedure provide a physical path for the implant member to respective ones of the embedded tissue anchors, the implant member moveable along the physical path to a position where the implant member is secured to the tissue under tension in the deployed configuration.

30. The implant kit of claim 29 wherein the tissue anchors and respective ones of the guide lines are integral structures comprised of at least one of a metal wire.

31. The implant kit of claim 29 wherein the tissue anchors and respective ones of the guide lines are unitary structures, each of the tissue anchors comprising at least one piercing element at a distal end of a respective one of the guide lines, wherein the at least one piercing element is configured to pierce the tissue.

32. The implant kit of claim 29 wherein the structure formed by the segments of the implant member has a C-shape profile.

33. The implant kit of claim 29, further comprising:

an implant cross connector attachable across an open portion of the implant member such that when attached, the implant cross connector and the structure formed by the segments of the implant member have a D-shape profile.

34. The implant kit of claim 29 wherein the implant member has a number of guide line receivers that ride on respective ones of the guide lines.

35. The implant kit of claim 29 wherein the implant member has at least three guide line receivers, at least a first guide line receiver proximate a first end of the implant member, a second guide line receiver proximate a second end of the implant member, and a third guide line receiver positioned along the structure formed by the segments between the first and the second guide line receivers.

36. The implant kit of claim 29 wherein the respective articulation joint of the implant member comprises a number of hinges that physically couple each of the segments of the implant member to at least one other of the segments of the implant member.

37. The implant kit of claim 36 wherein the implant member comprises a number of stops configured to limit a travel of each of the segments of the implant member with respect to another of the segments of the implant member.

38. The implant kit of claim 36 wherein the implant member comprises a number of stops configured to increase a torsional stiffness of each of the hinges when each of the segments of the implant member pivots by a defined amount with respect to another of the segments of the implant member.

39. The implant kit of claim 29 wherein the respective articulation joint of the implant member comprises a number of flexure joints that physically couple each of the segments of the implant member to at least one other of the segments of the implant member.

40. The implant kit of claim 39 wherein the implant member comprises a number of stops configured to limit a travel of each of the segments of the implant member with respect to another of the segments of the implant member.

41. The implant kit of claim 39 wherein the implant member comprises a number of stops configured to increase a bending stiffness of each of the flexure joints when each of the segments of the implant member flexes by a defined amount with respect to another of the segments of the implant member.

42. The implant kit of claim 29, further comprising:

an anchor guide frame having at least three anchor guide arms, wherein each of the tissue anchors is configured to be physically releasably guided by a respective one of the anchor guide arms of the anchor guide frame to a respective location on an annulus about the orifice in the tissue and embedded in the annulus at least proximate the respective locations.

43. The implant kit of claim 42 wherein the anchor guide arms each comprise an outer tube having at least a first outer tube lumen, and an inner tube having an inner tube lumen, the inner tube received in the first outer tube lumen of the outer tube for translational movement between a retracted position in which a distal end of the inner tube does not extend beyond a distal end of the first outer tube lumen and an extended position in which the distal end of the inner tube extends beyond the distal end of the first outer tube lumen, the inner tube lumen of the inner tube receiving a respective one of the guide lines for translation with respect thereto.

44. The implant kit of claim 43 wherein the distal end of the inner tube is in butting engagement with a portion of a respective one of the tissue anchors until the inner tube is withdrawn from the tissue anchor after the tissue anchor has been embedded in the tissue.

45. The implant kit of claim 43 wherein the tissue anchors each comprise at least one resilient barb, the at least one resilient barb protectively retained in the inner tube lumen of the inner tube until the inner tube is withdrawn from the tissue anchor after the tissue anchor has been embedded in the tissue.

46. The implant kit of claim 43 wherein the outer tube of each of the anchor guide arms further has a second outer tube lumen;

and the anchor guide frame further comprises a plurality of arms, each of the arms received in the second outer tube lumen of a respective one of the anchor guide arms.

47. The implant kit of claim 29 wherein the implant member has at least three guide line receivers that each ride on respective ones of the guide lines, wherein a circumference defined by a circle passing through at least three locations of the at least three guide line receivers on the implant member in the deployed configuration is smaller than a circumference defined by a circle passing through at least three locations of the embedded tissue anchors in the tissue prior to a physical coupling between the implant member and the embedded tissue anchors.

48. The implant kit of claim 29 wherein the implant member has at least three guide line receivers that each ride on respective ones of the guide lines, wherein a circumference defined by a circle passing through at least three locations of the at least three guide line receivers on the implant member in the deployed configuration is smaller than a circumference of an annulus of the orifice in the tissue prior to a physical coupling between the implant member and the embedded tissue anchors.

49. The implant kit of claim 29 wherein the implant member has at least three tissue anchor receivers, each of the tissue anchor receivers positioned to physically couple with a respective one of the plurality of tissue anchors, wherein a circumference defined by a circle passing through at least three locations of the at least three tissue anchor receivers on the implant member in the deployed configuration is smaller than a circumference defined by a circle passing through at least three locations of the embedded tissue anchors in the tissue prior to a physical coupling between the implant member and the embedded tissue anchors.

50. The implant kit of claim 29 wherein at least one of the tissue anchors comprises a helical tissue anchor.

51. The implant kit of claim 29 wherein the at least one of the tissue anchors comprises a grapple tissue anchor that includes at least two prongs pivotally coupled to each other, each of the two prongs having a tip shaped to pierce the tissue.

52. The implant kit of claim 29, further comprising a plurality of fasteners, each fastener movable along a respective one of the guide lines to a position where at least some of the fasteners secure the implant member to the tissue under tension in the deployed configuration.

53. The implant kit of claim 52 wherein each of the fasteners comprises a unidirectional clutch that in use allows the fastener to advance along a respective one of the guide lines toward a respective one of the embedded tissue anchors and prevents the fastener from retreating along the guide line away from the respective embedded tissue anchor.

54. The implant kit of claim 52 wherein the plurality of fasteners and the implant member are provided in a unitary structure.

55. The implant kit of claim 52 wherein the at least some of the fasteners are each fastenable to a respective one of the guide lines to secure the implant member to the tissue under tension in the deployed configuration.

56. The implant kit of claim 52 wherein the at least some of the fasteners are each fastenable to a respective one of the embedded tissue anchors to secure the implant member to the tissue under tension in the deployed configuration.

57. The implant kit of claim 29 wherein the implant member includes a plurality of receivers, each of the receivers having at least one of the guidelines passing therethrough, where all of the guidelines passing through a respective one of the receivers extend to a single respective one of the tissue anchors embedded in the tissue.

58. A method of operating a medical device system to constrict an orifice in tissue, the method comprising:

positioning a tool having a guide frame with a plurality of guide members such that distal ends of the guide members are at least proximate respective locations about a periphery of an orifice in a tissue internally within a body;

actuating the guide members to embed a plurality of tissue anchors in the tissue at least proximate respective ones of the respective locations about the periphery of the orifice in the tissue;

advancing an annuloplasty implant member to the tissue along a plurality of guide lines that extend from the embedded tissue anchors; and

securing the annuloplasty implant member to the embedded tissue anchors via a plurality of fasteners, the annuloplasty implant secured in an anchored configuration.

59. The method of claim 58, further comprising:

percutaneously delivering the guide frame into the body in a compressed configuration;

expanding the guide frame into an uncompressed configuration before positioning the tool such that the distal ends of the guide members are at least proximate their respective locations about the periphery of the orifice;

compressing the guide frame after actuating the guide members to embed the plurality of tissue anchors; and

percutaneously removing the guide frame from the body after compressing the guide frame.

60. The method of claim 59, further comprising:

percutaneously delivering the annuloplasty implant member into the body in an unanchored configuration after percutaneously removing the guide frame from the body.

61. The method of claim 60 wherein securing the annuloplasty implant member to the embedded tissue anchors via a plurality of fasteners, the annuloplasty implant secured in an anchored configuration comprises securing the annuloplasty implant member in an arch shape anchored proximate each of two ends, and proximate a location between the two ends, and percutaneously delivering the annuloplasty implant member into the body in an unanchored configuration comprises percutaneously delivering the annuloplasty implant member in an elongated scallop shape.

62. The method of claim 60, further comprising passing the guide lines through respective ones of a number of guide line receivers of the annuloplasty implant member before percutaneously delivering the annuloplasty implant member into the body in an unanchored configuration.

63. The method of claim 62 wherein actuating the guide members to embed a plurality of tissue anchors in the tissue at least proximate respective ones of the respective locations about the periphery of the orifice in the tissue comprises embedding the tissue anchors such that a circumference defined by a circle passing through at least three locations of respective ones of the tissue anchors embedded about the periphery of the orifice in the tissue is greater than a circumference defined by a circle passing through at least three locations of the guide line receivers on the annuloplasty member in the anchored configuration.

64. The method of claim 58 wherein actuating the guide members to embed a plurality of tissue anchors in the tissue comprises actuating the guide members to embed the plurality of tissue anchors having respective ones of the guide lines extending therefrom in the tissue.

65. The method of claim 58 wherein securing the annuloplasty implant member to the embedded tissue anchors via a plurality of fasteners, the annuloplasty implant secured in an anchored configuration comprises advancing each fastener along a respective one of the guide lines into contact with a respective portion of the annuloplasty implant member.

66. The method of claim 58 wherein securing the annuloplasty implant member to the embedded tissue anchors via a plurality of fasteners, the annuloplasty implant secured in an anchored configuration comprises advancing each fastener having a unidirectional clutch along a respective one of the guide lines.

67. The method of claim 58 wherein actuating the guide members to embed a plurality of tissue anchors in the tissue at least proximate respective ones of the respective locations about the periphery of the orifice in the tissue comprises extending a respective inner tube of each of the guide members from a lumen of a respective outer tube of each of the guide members, the inner tube advancing a respective one of the tissue anchors into the tissue.

68. The method of claim 67, further comprising withdrawing the inner tube of each of the guide members away from a respective one of the tissue anchors embedded in the tissue to expose at least one barb of the tissue anchor to the tissue.

69. The method of claim 67, further comprising retracting the inner tube of each of the guide members into the lumen of the outer tube of the respective one of the guide members while at least maintaining a position of the guide wire extending from a respective one of the tissue anchors with respect to the tissue.