GRIPPER PUSHER MECHANISM FOR TISSUE APPOSITION SYSTEMS

• US 20130066342A1
• Filed: 09/13/2011
• Published: 03/14/2013
• Est. Priority Date: 09/13/2011
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Dell, Kent, Tyler, Steven, Ketai, Theodore, Mishra, Tanmay, Jones, Stephanie, Greenberg, Jacob, Hong, Michael, Hale, Daniel, Valencia, Francisco
• Granted Patent: US 8,945,177 B2
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 2017/00243 cardiac
• 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

The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.

Claims

1. A system for fixing tissue, said system comprising:

an implantable tissue fixation device comprising a pair of fixation elements each having a first end, a free end opposite the first end, and an engagement surface therebetween for engaging the tissue, the fixation device further comprising a pair of gripping elements, each gripping element moveable with respect to one of the fixation elements and being disposed in opposition to one of the engagement surfaces so as to capture tissue therebetween; and

a gripper pusher releasably coupled to the implantable fixation device adjacent the pair of gripping elements, the gripper pusher having an expanded configuration and a collapsed configuration, wherein in the expanded configuration the gripper pusher engages the pair of gripping elements and advances the pair of gripping elements toward the engagement surfaces of the fixation elements, and wherein in the collapsed configuration the gripper pusher has a reduced radial profile relative to the gripper pusher radial profile in the expanded configuration thereby allowing the pair of gripping elements to move away from the engagement surfaces of the fixation elements.

2. The system of claim 1, wherein the first ends are movably coupled together such that the fixation elements are moveable between a closed position wherein the engagement surfaces face each other to an inverted position wherein the engagement surfaces face away from each other.

3. The system of claim 1, wherein each fixation element is at least partially concave such that each gripping element is separated from an opposing engagement surface in an undeployed configuration, and each gripping element is at least partially recessed within the fixation element in a deployed configuration.

4. The system of claim 2, wherein the fixation elements are further moveable to an open position between the closed position and the inverted position.

5. The system of claim 1, wherein the gripping elements are movable independently of the fixation elements.

6. The system of claim 1, wherein the gripping elements are biased toward the engagement surfaces.

7. The system of claim 1, wherein the gripping elements are approximately parallel to each other in an undeployed configuration.

8. The system of claim 1, wherein the gripper pusher comprises a spring element that moves from the collapsed configuration to the expanded configuration when a compressive force is applied thereto.

9. The system of claim 8, wherein the spring element comprises a longitudinal axis, and the compressive force is applied in a direction substantially parallel thereto.

10. The system of claim 8, wherein the spring element is resiliently biased to return to the collapsed configuration when the compressive force is released.

11. The system of claim 8, wherein the gripper pusher comprises two spring elements.

12. The system of claim 1, wherein the gripper pusher comprises an elongate deflectable arm.

13. The system of claim 12, wherein the deflectable arm is biased to return to the expanded configuration.

14. The system of claim 13, wherein proximal retraction of the proximal elements collapses the deflectable arm from the expanded configuration to the collapsed configuration.

15. The system of claim 12, wherein the arm comprises a plurality of peaks.

16. The system of claim 1, wherein the gripper pusher comprises an attachment mechanism for releasably attaching a distal portion of the gripper pusher to the implantable fixation device.

17. The system of claim 16, wherein the attachment mechanism comprises a notched region on the distal portion of the gripper pusher, and a boss adjacent a proximal end of the implantable fixation device, wherein the notched region is sized to accept the boss.

18. The system of claim 1, further comprising an elongate delivery shaft having a proximal portion and a distal portion, wherein the distal portion of the elongate delivery shaft is releasably coupled to a proximal portion of the gripper pusher.

19. The system of claim 18, wherein the gripper pusher comprises an attachment ring coupled to the proximal portion thereof, the attachment ring slidably disposed over the delivery shaft.

20. The system of claim 2, further comprising an actuation mechanism coupled to the fixation elements adapted to move the fixation elements between the closed position and the inverted position.

21. The system of claim 1, further comprising a coupling member for detachably coupling the fixation device to an elongate delivery shaft.

22. The system of claim 1, further comprising a covering on the fixation elements adapted for promoting tissue growth.

23. The system of claim 1, further comprising a coating on the fixation elements adapted for delivering a therapeutic agent.

24. A system for fixing tissue, said system comprising:

an implantable tissue fixation device comprising a pair of fixation elements, the pair of fixation elements comprising a first fixation element and a second fixation element, each fixation element having a first end, a free end opposite the first end, and an engagement surface therebetween for engaging the tissue, the fixation device further comprising a pair of gripping elements, the pair of gripping elements comprising a first gripping element and a second gripping element, the first gripping element moveable with respect to the first fixation element and being disposed in opposition to the engagement surface of the first fixation element so as to capture tissue therebetween, and the second gripping element moveable with respect to the second fixation element and being disposed in opposition to the engagement surface of the second fixation element so as to capture tissue therebetween; and

a first gripper actuator releaseably coupled to the implantable fixation device adjacent to the first gripping element, the first gripper actuator having a first configuration and a second configuration, wherein actuating the first gripper actuator between the first configuration and the second configuration moves the first gripping element with respect to the first fixation element.

25. The system of claim 24, further comprising a second gripper actuator releaseably coupled to the implantable fixation device adjacent to the second gripping element, the second gripper actuator having a first configuration and a second configuration, wherein acutating the second gripper actuator between the first configuration and the second configuration moves the second gripping element with respect to the second fixation element.

26. The system of claim 25, wherein the first gripper actuator and the second gripper actuator are actuatable between the first configurations and the second configurations independently of each other.

27. The system of claim 24, wherein the first ends are movably coupled together such that the fixation elements are moveable between a closed position wherein the engagement surfaces face each other and an inverted position wherein the engagement surfaces face away from each other.

28. The system of claim 27, further comprising an actuation mechanism coupled to the fixation elements adapted to move the fixation elements between the closed position and the inverted position.

29. The system of claim 24, wherein each fixation element is at least partially concave such that each gripping element is separated from an opposing engagement surface in an undeployed configuration, and each gripping element is at least partially recessed within the fixation element in a deployed configuration.

30. The system of claim 29, wherein the fixation elements are further moveable to an open position between the closed position and the inverted position.

31. The system of claim 24, wherein the gripping elements are movable independently of the fixation elements.

32. The system of claim 24, wherein the gripping elements are biased toward the engagement surfaces.

33. The system of claim 24, wherein the gripping elements are substantially parallel to each other in an undeployed configuration.

34. The system of claim 24, further comprising a gripper pusher releasably coupled to the implantable fixation device adjacent the pair of gripping elements, the gripper pusher having an expanded configuration and a collapsed configuration, wherein in the expanded configuration the gripper pusher engages one or more of the pair of gripping elements and advances one or more of the pair of gripping elements toward the engagement surfaces of the fixation elements, and wherein in the collapsed configuration the gripper pusher has a reduced radial profile relative to the gripper pusher radial profile in the expanded configuration thereby allowing the pair of gripping elements to move away from the engagement surfaces of the fixation elements.

35. The system of claim 26, wherein the first gripper actuator comprises a first wire and second gripper actuator comprises a second wire.

36. The system of claim 35, wherein the first wire and the second wire are substantially flat.

37. The system of claim 36, wherein a substantially flat side of the first wire is positioned to engage the first gripping element and a substantially flat side of the second wire is positioned to engage the second gripping element.

38. The system of claim 37, wherein the first wire is biased to bend along the substantially flat side of the first wire and wherein the second wire is biased to bend along the substantially flat side of the second wire.

39. The system of claim 26, wherein at least one of a distal end of the first gripper actuator or a distal end of the second gripper actuator is releaseably coupled to the implantation fixation device by a suture knot.

40. The system of claim 26, further comprising an elongate delivery shaft having a proximal portion and a distal portion, wherein the distal portion of the elongate delivery shaft is releasably coupled to a proximal portion of the fixation device.

41. The system of claim 40, wherein the first gripper actuator comprises a distal portion and the second gripper actuator comprises a distal portion, wherein the distal portions of the first gripper actuator and second gripper actuator are releasably coupled to at least one of the distal portion of the elongate delivery shaft or the proximal portion of the fixation device.

42. The system of claim 41, wherein the distal portions of the first gripper actuator and second gripper actuator each comprise a closed loop.

43. The system of claim 41, wherein the distal portions of the first gripper actuator and second gripper actuator each comprise a closed loop a coiled distal end.

44. The system of claim 40, wherein the proximal portion of the fixation device comprises a channel having a pair of notches, wherein the distal portion of the elongate delivery shaft comprises a pair of L-shaped ends resiliently biased to fit into the pair of notches, and wherein the distal portion of the elongate delivery shaft is releasably coupled to the proximal portion of the fixation device by placing the pair of L-shaped ends into channel of the fixation device and locking the pair of notches in the channel.

45. The system of claim 44, wherein the first gripper actuator and the second gripper actuator each comprise distal ends, and wherein placing the distal ends of the first gripper actuator and the second gripper actuator and coupling the distal portion of the elongate delivery shaft to the proximal portion of the fixation device locks the distal ends of the first gripper actuator and the second gripper actuator in place.

46. The system of claim 44, wherein the first gripper actuator and the second gripper actuator each comprise T-shaped distal ends.

47. The system of claim 46, further comprising a covering assembly coupled to and disposed over the distal portion of the elongate delivery shaft, the covering assembly comprising an outer slideable section and an inner section having a pair of T-shaped openings,

wherein the first gripper actuator and second gripper actuator are releaseably coupled to the fixation device by sliding the T-shaped distal ends of the first gripper actuator and second gripper actuator into the pair of the T-shaped opening of the inner section of the covering assembly and sliding the outer slideable section to cover the T-shaped openings.

48. The system of claim 26, wherein the first gripper actuator is releaseably coupled to the first gripping element and the second gripper actuator is releaseable coupled to the second gripping element.

49. The system of claim 48, wherein the first gripping element and the second gripping element each comprise portions extending radially outward.

50. The system of claim 49, further comprising a first holding element and a second holding element, wherein the first holding element is coupled to the first gripper actuator and releaseably coupled to the first gripping element at the portion extending radially outward of the first gripping element, and wherein the second holding element is coupled to the second gripper actuator and releaseably coupled to the second gripping element at the portion extending radially outward of the second gripping element.

51. The system of claim 50, wherein the first holding element comprises a first ring disposed over the portion extending radially outward of the first gripping element, and the second holding element comprises a second ring disposed over the portion extending radially outward of the second gripping element.

52. The system of claim 50, wherein the first holding element comprises a first clip releaseably attached to the portion extending radially outward of the first gripping element, and wherein the second holding element comprises a second clip releaseably attached to the portion extending radially outward of the second gripping element.

53. The system of claim 52, wherein the first clip comprises a pair of first clip legs disposed over length of the first gripping element, and the second clip comprises a pair of second clip legs disposed over length of the second gripping element.

54. The system of claim 49, wherein the portions extending radially outward of the first gripping element and the second gripping element each have apertures, wherein the first gripper actuator is threaded through the aperture of the portion extending radially outward of the first gripping element, and wherein the second gripper actuator is threaded through the aperture of the portion extending radially outward of the second gripping element.

55. The system of claim 54, wherein the first gripper actuator and the second gripper actuator each comprise an enlarged portion, wherein a diameter of the enlarged portions of the first gripper actuator may be greater than the diameter of the aperture of the portion extending radially outward of the first gripping element to facilitate moving the first gripping element, and wherein a diameter of the enlarged portions of the second gripper actuator may be greater than the diameter of the aperture of the portion extending radially outward of the second gripping element to facilitate moving the second gripping element.

56. The system of claim 55, wherein the enlarged portion of the first gripper actuator comprises a sleeve disposed over the first gripper mover and the englarged portion of the second gripper actuator comprises a sleeve disposed over the second gripper mover.

57. The system of claim 26, wherein the first gripper actuator and the second gripper actuator each comprise an actuation line and a release line.

58. The system of claim 57, wherein the actuation line of the first gripper actuator comprises a loop and the release line of the first gripper actuator comprises a single release cable threaded through the loop of the actuation line when the first gripper actuator is coupled to the first gripping element, and wherein the actuation line of the second gripper actuator comprises a loop and the release line of the second gripper actuator consists essentially of a single release cable threaded through the loop of the actuation line when the second gripper actuator is coupled to the second gripping element.

59. The system of claim 58, wherein pulling the single release cable of the first gripper actuator out through the loop of the actuation line of the first gripper actuator allows the first gripper actuator to be released from the first gripping element, and wherein pulling the single release cable of the second gripper actuator out through the loop of the actuation line of the second gripper actuator allows the first gripper actuator to be released from the second gripping element.

60. The system of claim 24, further comprising a coupling member for detachably coupling the fixation device to an elongate delivery shaft.

61. The system of claim 24, further comprising a covering on the fixation elements adapted for promoting tissue growth.

62. The system of claim 24, further comprising a coating on the fixation elements adapted for delivering a therapeutic agent.

63. A method for fixing tissue, said method comprising:

providing an implantable tissue fixation device comprising a pair of fixation elements each having a first end, a free end opposite the first end, and an engagement surface therebetween for engaging the tissue, the fixation device further comprising a pair of gripping elements, each gripping element moveable with respect to one of the fixation elements and being disposed in opposition to one of the engagement surfaces so as to capture tissue therebetween;

positioning the fixation element relative to tissue so that the tissue is disposed between the pair of gripping elements and the engagement surfaces of the pair of fixation element;

actuating a gripper actuation element to engage and displace one or more of the gripping elements; and

advancing the pair of gripping elements toward the engagement surfaces of the fixation elements.

64. The method of claim 63, further comprising:

providing a gripper pusher releasably coupled to the implantable fixation device adjacent the pair of gripping elements; and

wherein advancing the pair of gripping elements toward the engagement surfaces of the fixation elements comprises engaging the pair of gripping elements with the gripper pusher.

65. The method of claim 64, wherein engaging the pair of gripping elements with the gripper pusher comprises placing the gripper pusher into an expanded configuration from a collapsed configuration.

66. The method of claim 65, wherein the gripper pusher comprises a spring element having a longitudinal axis, and wherein engaging the pair of gripping elements with the gripper pusher comprises applying a compressive force to the spring element in a direction substantially parallel to the longitudinal axis to move the gripper pusher to the expanded configuration.

67. The method of claim 65, further comprising placing the gripper pusher into the collapsed configuration from the expanded configuration to reduce the radial profile of the gripper pusher relative to the gripper pusher radial profile in the expanded configuration to allow the pair of gripping elements to move away from the engagement surfaces of the fixation elements.

68. The method of claim 63, further comprising moving the first ends of the pair of the fixation elements between a closed position wherein the engagement surface face each other to an inverted position wherein the engagement surfaces face away from each other.

69. The method of claim 68, further comprising moving fixation elements to an open position between the closed position and the inverted position.

70. A method of fixing tissue, said method comprising:

providing an implantable tissue fixation device, the fixation device comprising a pair of fixation elements, the pair of fixation elements comprising a first fixation element and a second fixation element, each fixation element having a first end, a free end opposite the first end, and an engagement surface therebetween for engaging the tissue, the fixation device further comprising a pair of gripping elements, the pair of gripping elements comprising a first gripping element and a second gripping element, the first gripping element being disposed in opposition to the engagement surface of the first fixation element and the second gripping element being disposed in opposition to the engagement surface of the second fixation element;

positioning the fixation element relative to tissue so that the tissue is disposed between the first gripping element and the engagement surface of the first fixation element;

capturing the tissue between the first gripping element and the engagement surface of the first fixation element by moving the first gripping element with respect to the first fixation element, and

maintaining the position of the second gripping element with respect to the second fixation element while the first gripping element is moved with respect to the first fixation element.

71. The method of claim 70, further comprising providing a first gripping element actuator coupled to the first gripping element and providing a second gripping element actuator coupled to the second gripping element, wherein

capturing the tissue between the first gripping element and the engagement surface of the first fixation element comprises moving the first gripping element actuator to move the first gripping element;

and

maintaining the position of the second gripping element with respect to the second fixation element comprises holding the second gripping element actuator stationary relative to the second gripping element.

72. The method of claim 70, further comprising releasing the captured tissue between the first gripping element and the engagement surface of the first fixation element by moving the first gripping element away from the first fixation element.

73. The method of claim 72, further comprising repositioning the fixation element relative to the tissue.

74. The method of claim 70, further comprising positioning the fixation element relative to tissue so that the tissue is disposed between the second gripping element and the engagement surface of the second fixation element;

and

capturing the tissue between the second gripping element and the engagement surface of the second fixation element by moving the second gripping element with respect to the second fixation element.

75. The method of claim 74, further comprising releasing the captured tissue between the first gripping element and the engagement surface of the first fixation element by moving the first gripping element away from the first fixation element;

and

releasing the captured tissue between the second gripping element and the engagement surface of the second fixation element by moving the second gripping element away from the second fixation element.

76. The method of claim 75, further comprising repositioning the fixation element relative to the tissue.

77. A system for fixing tissue, said system comprising:

an implantable tissue fixation device comprising a pair of fixation elements, the pair of fixation elements comprising a first fixation element and a second fixation element, each fixation element having a first end, a free end opposite the first end, and an engagement surface therebetween for engaging the tissue, the fixation device further comprising a pair of gripping elements, the pair of gripping elements comprising a first gripping element and a second gripping element, the first gripping element moveable with respect to the first fixation element and being disposed in opposition to the engagement surface of the first fixation element so as to capture tissue therebetween, and the second gripping element moveable with respect to the second fixation element and being disposed in opposition to the engagement surface of the second fixation element so as to capture tissue therebetween;

a first gripper actuator releaseably coupled to the implantable fixation device adjacent to the first gripping element, the first gripper actuator having a first configuration and a second configuration, wherein actuating the first gripper actuator between the first configuration and the second configuration moves the first gripping element with respect to the first fixation element;

a gripper pusher releasably coupled to the implantable fixation device adjacent the pair of gripping elements, the gripper pusher having an expanded configuration and a collapsed configuration, wherein in the expanded configuration the gripper pusher engages one or more of the pair of gripping elements and advances one or more of the pair of gripping elements toward the engagement surfaces of the fixation elements, and wherein in the collapsed configuration the gripper pusher has a reduced radial profile relative to the gripper pusher radial profile in the expanded configuration thereby allowing the pair of gripping elements to move away from the engagement surfaces of the fixation elements;

a delivery catheter for delivering the implantable fixation device; and

a handle configured to actuate the pair of fixation elements, the first gripper actuator and the gripper pusher simultaneously.

78. The system according to claim 77, wherein the handle comprises an actuator rod actuator for actuating the pair of fixation elements;

a first gripper actuator handle for actuating the first gripper actuator;

a pusher attachment connected to the first gripper actuator handle to actuate the gripper pusher; and

a gripper pusher retraction wire configured to couple a retraction of the first gripper actuator and the pusher attachment with the actuating of the pair of fixation elements.

79. The system according to claim 78, wherein the handle is further configured to retract the first gripper actuator and the first gripper actuator handle when the actuator rod actuator is actuated to reduce the angle between the pair of fixation elements.

80. The system according to claim 79, wherein the pusher attachment is connected to the first gripper actuator handle using a spring to enable a different amount of displacement between the gripper pusher and the first gripping element.