Delivery devices and methods for heart valve repair

• US 20050107811A1
• Filed: 07/27/2004
• Published: 05/19/2005
• Est. Priority Date: 06/13/2002
• Status: Abandoned Application

• Current Assignee: Guided Delivery Systems, Inc.
• Original Assignee: Guided Delivery Systems, Inc.
• Inventors: Starksen, Niel F., To, John, Morales, Rodolfo A., Fabro, Mariel, Wei, Michael F.
• Application Number:
  US10/900,980
• Publication Number:
  US 20050107811A1
• Time in Patent Office: Days
• US Class Current: 606/143
• 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 17/0401 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/2905 flexible
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 : Delivery devices therefor

Abstract

Devices, systems and methods facilitate positioning of a cardiac valve annulus treatment device, thus enhancing treatment of the annulus. Methods generally involve advancing an anchor delivery device through vasculature of the patient to a location in the heart for treating the valve annulus, contacting the anchor delivery device with a length of the valve annulus, delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus, and drawing the anchors together to circumferentially tighten the valve annulus. Devices generally include an elongate catheter having at least one tensioning member and at least one tensioning actuator for deforming a distal portion of the catheter to help it conform to a valve annulus. The catheter device may be used to navigate a subannular space below a mitral valve to facilitate positioning of an anchor delivery device.

Claims

1. An anchor assembly for use along a length of target tissue within a patient comprising:

a housing constructed to be passable through a blood vessel and into a heart;

the housing comprising a longitudinal axis and anchor delivery positions corresponding to anchor engagement locations along the length of the target tissue;

a series of tissue-engageable anchors removably carried by the housing, the anchors comprising a distal anchor and a proximal anchor;

the anchors being positioned at the anchor delivery positions for delivery from the housing to the length of target tissue; and

a tether coupling the anchors to one another.

2. The assembly according to claim 1 wherein at least a portion of the housing is flexible.

3. The assembly according to claim 2 further comprising means for urging the flexible portion of the housing from a first configuration to a second, radially outwardly expanded, curved configuration.

4. The assembly according to claim 2 wherein the housing is steerable.

5. The assembly according to claim 1 wherein the distal anchor is fixed to the tether and the proximal anchor is slidably coupled to the tether.

6. The assembly according to claim 1 wherein the tether is located substantially external of the catheter-type housing.

7. The assembly according to claim 1 wherein the anchors are self-forming and self-securing anchors.

8. The assembly according to claim 1 wherein at least one of the anchors comprises a bioactive agent.

9. The assembly according to claim 1 wherein at least one of the anchors comprises an electrode.

10. The assembly according to claim 9 wherein the electrode senses at least one of impedance, temperature, and electrical signals.

11. The assembly according to claim 9 wherein the electrode comprises an energy-application electrode to supply energy to tissue at least one of ablation and sub-ablation amounts.

13. The assembly according to claim 1 wherein

the anchors have a first part and a second part, the second part having a tissue-piercing tip;

the anchors are placeable in a relatively straight, undeployed state generally parallel to the longitudinal axis when carried by the housing; and

the anchors naturally assume a curved, tissue-engaging deployed state after being deployed from the housing.

14. The assembly according to claim 1 wherein:

the housing has openings at the anchor delivery positions sized for passage of the anchors therethrough when the anchors are deployed from the housing.

17. The device according to claim 13 wherein the anchors comprise said first part and at least two of said second parts extending from the first part.

18. The device according to claim 17 wherein the second parts extend in directions generally opposite one another when in the deployed state.

19. The device according to claim 18 wherein the second parts of said anchor have generally circular or semicircular shapes when in the deployed state.

20. The device according to claim 13 wherein the anchors are oriented generally perpendicular to the longitudinal axis when in the deployed state.

21. The device according to claim 13 wherein the second parts of the anchors have generally circular or semicircular shapes when in the deployed state.

23. The device according to claim 13 wherein the housing has the diametrical dimension d and the anchors in the deployed state have ha diametrical dimension D, and wherein the ratio of D to d is at least 3.5.

24. The device according to claim 13 wherein the housing has the diametrical dimension d and the anchors in the deployed state have a diametrical dimension D, and wherein the ratio of D to d is at least 4.4.

25. The device according to claim 13 wherein the housing has the diametrical dimension d and the anchors in the deployed state have a diametrical dimension D, and wherein the ratio of D to d is at least 7.

26. The device according to claim 13 wherein the housing has the diametrical dimension d and the anchors in the deployed state have a diametrical dimension D, and wherein the ratio of D to d is at least 8.8.

27. The assembly according to claim 13 wherein the anchor comprises a bioactive agent.

31. The assembly according to claim 13 wherein

the anchors comprise means for causing the tissue-piercing tips passing into tissue to secure the anchors to the tissue as the second parts move to the curved, deploy state without any further force applied to the anchor.

34. The assembly according to claim 13 wherein at least some of the anchors comprise first and second of the second parts.

35. The assembly according to claim 34 wherein at least one of the second parts comprises a hook.

36. The assembly according to claim 34 wherein both of the second parts comprises a hook.

37. The assembly according to claim 36 wherein the hooks extend in directions generally opposite one another when in the unrestrained state.

42. The assembly according to claim 1 wherein the housing is a tubular housing.

87. The assembly according to claim 1 wherein the housing is a catheter-type housing having an open interior and the anchors are removably housed within the housing interior.

12. An anchor assembly for use alone a length of target tissue within a patient comprising:

a catheter-type housing, having an open interior, constructed to be passable through a blood vessel and into a heart, at least a portion of the housing being flexible;

means for urging the flexible portion of the housing from a first configuration to a second, radially outwardly expanded, curved configuration;

a series of tissue-engageable anchors removably housed within the open interior of the housing, the anchors located at positions along the housing corresponding to anchor engagement locations along the target tissue;

the anchors being self-forming and self-securing anchors; and

a tether serially coupling the anchors to one another.

15-16. -16. (canceled)

22. (canceled)

28-30. -30. (canceled)

32-33. -33. (canceled)

38-41. -41. (canceled)

43-50. -50. (canceled)

51. A tissue anchor assembly for use along a length of target tissue within a patient comprising:

a plurality of anchors, each anchor comprising a base and first and second self-forming, tissue-engaging portions extending from the base, the tissue-engaging portions each comprising a tissue-piercing tip;

a housing;

the anchors located at positions along the housing corresponding to anchor engaging locations along the length of taroet tissue;

the tissue-engaging portions each movable between a curved, unrestrained state and a straightened, restrained state;

the tissue-engaging portions each having a generally circular or semicircular shape when in the unrestrained state;

a tether coupled to the bases of the anchors;

at least one said anchor being slidably coupled to the tether and another of said anchors being fastened to the tether; and

the anchors and tether being releasably mounted to the housing with the tissue-engaging portions in the restrained state, the tissue-engaging portions transferable from the restrained state to the unrestrained state when the anchors and tether are released from the housing so that the tissue-piercing tips passing into tissue secures the anchor to the tissue as the tissue-engaging portion moves to the curved, unrestrained state without any further force applied to the anchor.

52. A tissue anchor assembly comprising:

an anchor comprising a base and a resilient, self-forming, tissue-engaging portion extending from the base, the tissue-engaging portion comprising a tissue-piercing tip;

the tissue-engaging portion movable between a curved, unrestrained state and a restrained state;

a coupling element coupled to the anchor;

a housing having a centerline and a distal end;

the anchor releasably mounted to the housing with the tissue-engaging portion in the restrained state oriented generally parallel to the centerline, the tissue-engaging portion transformable from the restrained state to the unrestrained state when the anchor is released from the housing in a direction transverse to the centerline; and

the tissue-engaging portion comprising means for pulling the anchor into the tissue as the tissue-piercing tip passes into tissue and the tissue-engaging portion moves to the curved, unrestrained state.

53. The assembly according to claim 52 wherein the tissue-engaging portion has a generally circular or semicircular shape when in the unrestrained state.

54. The assembly according to claim 52 wherein the tissue-engaging portion is straightened when in the restrained state.

55. The assembly according to claim 52 wherein the anchor comprises first and second of the tissue-engaging portions.

56. The assembly according to claim 55 wherein the first tissue-engaging portion comprises a hook.

57. The assembly according to claim 55 wherein each of the first and second tissue-engaging portions comprises a hook.

58. The assembly according to claim 57 wherein the hooks extend in directions generally opposite one another when in the unrestrained state.

59. The assembly according to claim 55 wherein the tissue-engaging portions extend in directions generally opposite one another when in the unrestrained state.

60. The assembly according to claim 52 wherein the coupling element comprises a tether coupled to the base of the anchor.

61. The assembly according to claim 60 wherein the tether is slidably coupled to the base of the anchor.

62. The assembly according to claim 52 wherein the coupling element comprises a flexible string-like element.

63. The assembly according to claim 60 wherein the housing is a tubular housing.

64. The assembly according to claim 60 wherein the anchor is releasably mounted within the tubular housing.

65. The assembly according to claim 52 wherein the hook is generally straight when in the restrained state.

66. The assembly according to claim 52 further comprising a plurality of said anchors with the coupling element coupled to each said anchor.

67. The assembly according to claim 66 wherein at least one said anchor is slidably coupled to the coupling element and another of said anchors is fastened to the coupling element.

68. The assembly according to claim 52 wherein the anchor pulling means comprises means for storing potential energy when in the restrained state.

69. The assembly according to claim 52 wherein the anchor comprises a bioactive agent.

70. The assembly according to claim 52 wherein the anchor comprises an electrode.

71. The assembly according to claim 70 wherein the electrode senses at least one of impedance, temperature, and electrical signals.

72. The assembly according to claim 70 wherein the electrode comprises an energy-application electrode to supply energy to tissue at least one of ablation and sub-ablation amounts.

73. A tissue anchor assembly for use along a length of target tissue within a patient comprising:

a plurality of anchors, each anchor comprising a base and a first and second resilient, self-forming, tissue-engaging portions extending from the base, the tissue-engaging portions each comprising a tissue-piercing tip;

the tissue-engaging portions each movable between a curved, unrestrained state and a restrained state;

the tissue-engaging portions each having a generally circular or semicircular shape when in the unrestrained state;

a coupling element coupled to each of the anchors;

a tubular housing having a centerline;

the anchors releasably mounted within the housing at positions corresponding to anchor in engaging locations along a length of target tissue with the tissue-engaging portions in the restrained state, the tissue-engaging portions transformable from the restrained state to the unrestrained state when the anchors are released from the housing;

the tissue-engaging portions comprising means for pulling the anchors into the tissue as the tissue-piercing tips pass into tissue and the tissue-engaging portions move to the curved, unrestrained states; and

the anchor pulling means comprising means for storing potential energy when in the restrained state.

74. A method for securing an anchor to a length of target tissue of a patient comprising:

directing an anchor assembly, comprising an anchor carried by an anchor carrier, to a target tissue site, the anchor carrier comprising a distal end; and

releasing the anchor from the anchor carrier at a position spaced apart from the distal end, the releasing step comprising;

placing a tissue-piercing tip of the anchor into engagement with the tissue at the target tissue site; and

the anchor pulling itself into the tissue as the anchor moves from a restrained state to an unrestrained state.

75. The method according to claim 74 wherein the anchor assembly directing step is carried out with a tubular anchor carrier releasably housing the anchor.

76. The method according to claim 74 wherein the anchor assembly directing step is carried out with the anchor having a first part and a second part, the second part naturally assuming a curved shape when the anchor is in the unrestrained state.

77. The method according to claim 74 wherein the anchor assembly directing step is carried out with the anchor having a first part and a second part, the second part naturally assuming a curved, generally circular or semicircular shape when the anchor is in the unrestrained state.

78. The method according to claim 74 wherein the anchor assembly directing step is carried out with the anchor having a first part and at least two second parts, each second part naturally assuming a curved, generally circular or semicircular shape when the anchor is in the unrestrained state.

79. The method according to claim 78 wherein the anchor pulling step comprises bracing said two second parts against one another through the first part whereby problems associated with tissue deflection are at least substantially reduced.

80. The method according to claim 74 wherein the anchor assembly directing step is carried out with a plurality of the anchors coupled to one another by a tether, each anchor having a first part and a second part, the second part naturally assuming a curved, generally circular or semicircular shape when the anchor is in the unrestrained state.

81. The method according to claim 74 wherein the anchor assembly directing step is carried out with a plurality of the anchors coupled to one another by a tether, each anchor having a first part and at least two second parts, each second part naturally assuming a curved, generally circular or semicircular shape when the anchor is in the unrestrained state.

82. The method according to claim 74 wherein the directing step is carried out with an anchor comprising a bioactive agent.

83. The method according to claim 74 wherein the directing step is carried out with an anchor comprising an electrode.

84. The method according to claim 83 further comprising sensing, through the electrode, at least one of impedance, temperature, and electrical signals.

85. The method according to claim 83 further comprising supplying the electrode energy in at least one of ablation and sub-ablation amounts.

86. The method according to claim 74 wherein the anchor assembly directing step is carried out with a plurality of the anchors coupled to one another by a tether, and further comprising simultaneously positioning the anchors at positions along the length of target tissue prior to the releasing step.