INDEPENDENT GRIPPER

• US 20130066341A1
• 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: Hong, Michael, KETAI, Theodore, GREENBERG, Jacob, HALE, Daniel, MISHRA, Tanmay, GONZALES, Gabriel, BASUDE, Raghuveer
• Granted Patent: US 9,011,468 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 17/10 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 2/246 Devices for obstructing a leak through a native valve in a closed condition
• 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 fixation system for engaging tissue comprising:

an implantable 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 first ends being movably coupled together such that the fixation elements are moveable between a closed position wherein the engagement surfaces face each other to a first open position wherein the engagement surfaces are positioned away from each other;

an actuation mechanism coupled to the fixation elements adapted to move the fixation elements between the closed position and the first open position; and

a pair of gripping elements comprising a first gripping element and a second gripping element, each of the gripping elements moveable with respect to one of the fixation elements and configured to be moved in opposition to one of the engagement surfaces so as to capture tissue therebetween; and

a first gripper actuator releasably coupled to the implantable fixation device and configured to individually actuate the gripping elements.

2. The fixation system according to claim 1, wherein the free ends are moveably coupled to move between a closed position where the engagement surfaces face each other and a closed position where the engagement surfaces face away from one another.

3. The fixation system according to claim 1, wherein the fixation elements each have a concave portion for receiving a corresponding one of the pair of gripping elements when the gripping elements are moved into opposition to one of the engagement surfaces.

4. The fixation system according to claim 1, wherein the first gripping actuator is releasably coupled to the implantation fixation device and being actuatable between a first configuration and a second configuration that moves the first gripping element toward a first fixation element of the pair of fixation elements.

5. The fixation system according to claim 4, wherein the first gripper actuator is actuatable between the second configuration and a third configuration that moves the second gripping element toward a second fixation element of the pair of fixation elements independently of the movement of the first gripping element.

6. The fixation system according to claim 1, further comprising an elongate delivery shaft having a proximal portion and a distal portion, wherein the distal portion is releasably coupled to the proximal portion of the implantable fixation device.

7. The fixation system according to claim 6, wherein the gripper actuator comprises a proximal end and a distal end, the distal end being releasably coupled to at least one of the proximal end of the implantable fixation device or the distal end of the elongate delivery shaft.

8. The fixation system according to claim 6, wherein the gripper actuator comprises a gripper line that extends from the proximal end of the delivery shaft and is coupled to each of the first gripping element and the second gripping element at portions of the gripper line between the proximal end of the delivery shaft and releasably coupled to at least one of the proximal end of the implantable fixation device or the distal end of the elongate delivery shaft.

9. The fixation system according to claim 6, wherein the gripper line is actuated by tension on the gripper line and is configured to apply a different resultant force the each of the first gripping element and the second gripping element to induce the individual activation of the gripping elements at different levels of tension.

10. The fixation system according to claim 6, wherein the gripper actuator is released from the implantable fixation device when the elongate delivery shaft is decoupled from the implantable fixation device.

11. The fixation system according to claim 8, wherein the gripper line is releasably fixed to the implantation fixation device.

12. The fixation system according to claim 8, wherein the gripper actuator is released from the implantable fixation device when the elongate delivery shaft is decoupled from the implantable fixation device.

21. The fixation system according to claim 1, 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 the pair of gripping elements and advances the pair of gripping elements toward the engagement surfaces of the fixation elements.

22. The fixation system according to claim 21, 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.

23. The fixation system according to claim 21, wherein the first gripping actuator is releasably coupled to the implantation fixation device and being actuatable between a first configuration and a second configuration that moves the first gripping element toward a first fixation element of the pair of fixation elements.

24. The fixation system according to claim 23, wherein the first gripper actuator is actuatable between the second configuration and a third configuration that moves the second gripping element toward a second fixation element of the pair of fixation elements independently of the movement of the first gripping element.

25. The fixation system according to claim 21, further comprising an elongate delivery shaft having a proximal portion and a distal portion, wherein the distal portion is releasably coupled to the proximal portion of the implantable fixation device.

26. The fixation system according to claim 25, wherein the gripper actuator comprises a proximal end and a distal end, the distal end being releasably coupled to at least one of the proximal end of the implantable fixation device or the distal end of the elongate delivery shaft.

32. The fixation system according to claim 25, wherein a distal portion of the gripper pusher is releasably attached to the implantable fixation device.

33. The fixation system according to claim 32, wherein the gripper pusher comprises a pair of elongate flexible arms and a shaft of the implantable fixation device includes apertures for releasably engaging a distal end of each of the pair of elongate flexible arms.

36. The fixation system according to claim 33, wherein a proximal portion of the implantable fixation device comprises a pair of apertures, wherein the distal portion of the elongate delivery shaft comprises a pair of L-shaped ends resiliently biased to fit into the pair of apertures, wherein the distal ends of the pair of elongate flexible arms are releasably coupled to the implantable fixation device by being fitted into the apertures and with the pair of L-shaped ends.

38. The fixation system according to claim 36, further comprising an actuation rod configured to extend through the elongate delivery shaft and into the implantable fixation device to actuate the pair of fixation elements, wherein the fixation system is configured such that withdrawal of the actuation rod from the implantable fixation device releases the L-shaped ends and the distal ends of the pair of elongate flexible arms from the implantable fixation device.

40. The fixation system according to claim 6, wherein the first gripper actuator comprises a distal end, and wherein placing the distal end of the first gripper actuator adjacent a distal end of the elongate delivery shaft and coupling the distal portion of the elongate delivery shaft to the proximal portion of the fixation device locks the distal end of the first gripper actuator in position.

42. The fixation system according to claim 40, wherein the distal end of the first gripper actuator comprises a narrow portion and a wide portion, and wherein the elongate delivery shaft and the fixation device are shaped to form a hollow portion that when coupled together that holds the wide portion of the first gripper actuator in position.

44. The fixation system according to claim 40, wherein the distal end of the first gripper actuator comprises a narrow portion and a wide portion, wherein the elongate delivery shaft includes an open slot having a width narrower than the wide portion of the first gripper actuator and the fixation device closes the open slot when coupled to the elongate delivery shaft to hold the first gripper actuator in position.

46. The fixation system according to claim 40, 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 T-shaped opening,

wherein the first gripper actuator is releasably coupled to the fixation device by sliding a T-shaped distal end of the first gripper actuator into 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 fixation system according to claim 6, further comprising an actuator rod that extends through the delivery shaft and into the implantable fixation device to actuate the pair of fixation elements, wherein the delivery shaft comprises an opening portion and a liner disposed inside of the delivery shaft configured to occlude the opening portion, and wherein the first gripper actuator is disposed in the opening portion and fixed by the liner when the actuator rod is extended into the implantable fixation device and released by the liner when the actuator rod is withdraw from the implantable fixation device.

50. The fixation system according to claim 48, wherein the liner is hingedly attached to the delivery shaft.

52. The fixation system according to claim 6, further comprising an actuator rod that extends through the delivery shaft and into the implantable fixation device to actuate the pair of fixation elements, wherein the delivery shaft comprises opening portions and spring members disposed on the exterior of the delivery shaft having bent portions that extend into the opening portions, each spring member having a notched end, wherein the notched ends of the spring members abut to form an opening sized to releasably engage the first gripper actuator.

53. The fixation system according to claim 52, wherein the actuator rod has a taper shape configured to press the bent portions when the actuator rod is withdrawn from the implantable fixation device to release the first gripper actuator by causing the notched ends to separate.

55. The fixation system according to claim 52, wherein the actuator rod has a taper shape configured to press the bent portions when the actuator rod is withdrawn from the implantable fixation device to release the first gripper actuator and the second gripper actuator by causing the notched ends to separate.

13. A fixation system for engaging tissue comprising:

an implantable fixation device comprising a pair of fixation elements comprising a first fixation element and a second fixation element, each having a first end, a free end opposite the first end, and an engagement surface therebetween for engaging the tissue, the first ends being movably coupled together such that the fixation elements are moveable between a closed position wherein the engagement surfaces face each other to a first open position wherein the engagement surfaces are positioned away from each other;

an actuation mechanism coupled to the fixation elements adapted to move the fixation elements between the closed position and the first open position; and

a pair of gripping elements comprising a first gripping element and a second gripping element, each of the gripping elements moveable with respect to one of the fixation elements and configured to be moved in opposition to one of the engagement surfaces so as to capture tissue therebetween;

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

14. The fixation system according to claim 13, wherein the first gripper actuator and the second gripper actuator are actuatable between the first configuration and the second configuration independently of each other.

15. The fixation system according to claim 14, wherein the first gripper actuator comprises a first gripper line having a proximal end and a distal end, and the second gripper actuator comprises a second gripper line having a proximal end and a distal end,

wherein the distal portions of the first gripper line and the second gripper line are releasably coupled to the implantable fixation device.

16. The fixation device according to claim 14, 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.

17. The fixation system according to claim 16, wherein the first gripper actuator comprises a first gripper line having a proximal end and a distal end, and the second gripper actuator comprises a second gripper line having a proximal end and a distal end,

wherein the distal portions of the first gripper line and the second gripper line are releasably coupled to at least one of the proximal end of the implantable fixation device or the distal end of the elongate delivery shaft.

18. The fixation system according to claim 13, wherein the first gripper actuator and the second gripper actuator are releasably fixed to the implantation fixation device.

19. The fixation system according to claim 16, wherein the first gripper actuator and the second gripper actuator are releasably fixed to the implantation fixation device.

20. The fixation system according to claim 16, wherein the first gripper actuator and the second gripper actuator are released from the at least one of the proximal end of the implantable fixation device or the distal end of the elongate delivery shaft, when the elongate delivery shaft is decoupled from the implantable fixation device.

27. The fixation system according to claim 13, 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 the pair of gripping elements and advances the pair of gripping elements toward the engagement surfaces of the fixation elements.

28. The fixation system according to claim 27, wherein the first gripper actuator and the second gripper actuator are actuatable between the first configuration and the second configuration independently of each other.

29. The fixation system according to claim 27, 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.

30. The fixation system according to claim 28, wherein the first gripper actuator comprises a first gripper line having a proximal end and a distal end, and the second gripper actuator comprises a second gripper line having a proximal end and a distal end,

wherein the distal portions of the first gripper line and the second gripper line are releasably coupled to the implantable fixation device.

31. The fixation system according to claim 28, 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.

34. The fixation system according to claim 27, wherein a distal portion of the gripper pusher is releasably attached to the implantable fixation device.

35. The fixation system according to claim 34, wherein the gripper pusher comprises a pair of elongate flexible arms and a shaft of the implantable fixation device includes apertures for releasably engaging a distal end of each of the pair of elongate flexible arms.

37. The fixation system according to claim 35, wherein a proximal portion of the implantable fixation device comprises a pair of apertures, wherein the distal portion of the elongate delivery shaft comprises a pair of L-shaped ends resiliently biased to fit into the pair of apertures, wherein the distal ends of the pair of elongate flexible arms are releasably coupled to the implantable fixation device by being fitted into the apertures and with the pair of L-shaped ends.

39. The fixation system according to claim 37, further comprising an actuation rod configured to extend through the elongate delivery shaft and into the implantable fixation device to actuate the pair of fixation elements, wherein the fixation system is configured such that withdrawal of the actuation rod from the implantable fixation device releases the L-shaped ends and the distal ends of the pair of elongate flexible arms from the implantable fixation device.

41. The fixation system according to claim 16, 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 adjacent the distal portion of the elongate deliver shaft 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 position.

43. The fixation system according to claim 41, wherein the distal ends of the first gripper actuator and the second gripper actuator comprises a narrow portion and a wide portion, and wherein the elongate delivery shaft and the fixation device are shaped to form hollow portions when coupled together that hold the wide portion of the first gripper actuator and the second gripper actuator in position.

45. The fixation system according to claim 41, wherein the distal ends of the first gripper actuator and the second gripper actuator include a narrow portion and a wide portion, wherein the elongate delivery shaft includes open slots having a width narrower than the wide portion of the first and second gripper actuators and the fixation device closes the open slots when coupled to the elongate delivery shaft to hold the first gripper actuator and the second gripper actuator in position.

47. The fixation system according to claim 41, 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 releasably 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.

49. The fixation system according to claim 16, further comprising an actuator rod that extends through the delivery shaft and into the implantable fixation device to actuate the pair of fixation elements, wherein the delivery shaft comprises opening portions and liners disposed inside of the delivery shaft configured to occlude the opening portions, and wherein the pair of gripper actuators are disposed in a corresponding one of the opening portions and fixed by the liners when the actuator rod is extended into the implantable fixation device and released by the liners when the actuator rod is withdraw from the implantable fixation device.

51. The fixation system according to claim 49, wherein the liners are hingedly attached to the delivery shaft.

54. The fixation system according to claim 16, further comprising an actuator rod that extends through the delivery shaft and into the implantable fixation device to actuate the pair of fixation elements, wherein the delivery shaft comprises opening portions and spring members disposed on the exterior of the delivery shaft having bent portions that extend into the opening portions, each spring member having a notched end, wherein the notched ends of the spring members abut to form an opening sized to releasably engage the first gripper actuator and the second gripper actuator.

56. A method for fixing tissue, said method comprising;

providing an implantable 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 first ends being movably coupled together such that the fixation elements are moveable between a closed position wherein the engagement surfaces face each other to a first open position wherein the engagement surfaces are positioned away from each other;

an actuation mechanism coupled to the fixation elements adapted to move the fixation elements between the closed position and the first open position; and

a pair of gripping elements comprising a first gripping element and a second gripping element, each of the gripping elements moveable with respect to one of the fixation elements and configured to be moved in opposition to one of the engagement surfaces so as to capture tissue therebetween;

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

activating a first gripper actuator to individually actuate the first gripping elements to grasp tissue between the first gripping element and one of the fixation elements.

57. The method according to claim 56, further comprising activating the first gripper actuator to actuate the second gripping element to grasp tissue between the second gripping element and the other of the fixation elements while the first gripping element is engaged with tissue.

58. The method according to claim 56, providing a gripper pusher releasably coupled to the implantable fixation device adjacent the pair of gripping elements;

and

wherein individually actuating the first gripper element comprises engaging the pair of gripping elements with the gripper pusher.

59. The method according to claim 56, wherein the first gripper actuator comprises a proximal end and a distal end, the distal end being releasable coupled to the implantable fixation device.

60. The method according to claim 56, further comprising removing an actuator rod for actuating the actuation mechanism that causes an elongated delivery shaft to decouple from the implantable fixation device and causes the first gripper actuator to be released from the implantable fixation device.