Fixation device and methods for engaging tissue

• US 20040049207A1
• Filed: 05/19/2003
• Published: 03/11/2004
• Est. Priority Date: 04/09/1999
• Status: Active Grant

• Current Assignee: Evalve, Inc. (Abbott Laboratories)
• Original Assignee: Evalve, Inc. (Abbott Laboratories)
• Inventors: Sarabia, Jaime E., Komtebedde, Jan, Dell, Kent D., Goldfarb, Eric A., Powell, Ferolyn T., Wen Chin Fan, Sylvia, Raschdorf, Alfred H. Jr.
• Granted Patent: US 7,563,267 B2
• Time in Patent Office: Days
• US Class Current: 606/139
• 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 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• 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 17/0469 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 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• 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 17/07207 the staples being applied sequentially
• 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 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/20 : using laser
• CPC Class Codes: A61B 2017/00243 : cardiac
• CPC Class Codes: A61B 2017/00575 : for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 : Barbed implements
• CPC Class Codes: A61B 2017/00588 : Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• CPC Class Codes: A61B 2017/00592 : Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 : Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00615 : Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00619 : Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 : Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00783 : Valvuloplasty
• CPC Class Codes: A61B 2017/00867 : shape memory effect
• CPC Class Codes: A61B 2017/0406 : Pledgets
• CPC Class Codes: A61B 2017/0409 : Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0417 : T-fasteners
• CPC Class Codes: A61B 2017/0419 : H-fasteners
• CPC Class Codes: A61B 2017/0429 : the barbs being expanded by a mechanical mechanism which also locks them in the expanded state
• CPC Class Codes: A61B 2017/0435 : the barbs being separate elements mechanically linked to the anchor, e.g. by pivots
• CPC Class Codes: A61B 2017/0458 : Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/047 : having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body
• CPC Class Codes: A61B 2017/0472 : Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0474 : Knot pushers
• CPC Class Codes: A61B 2017/0488 : Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06052 : Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2017/06057 : Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/06076 : helically or spirally coiled
• CPC Class Codes: A61B 2017/061 : hollow or tubular
• CPC Class Codes: A61B 2017/06171 : helically or spirally coiled
• CPC Class Codes: A61B 2017/0641 : having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/088 : Sliding fasteners
• CPC Class Codes: A61B 2017/2908 : Multiple segments connected by articulations
• CPC Class Codes: A61B 2017/2926 : Details of heads or jaws
• CPC Class Codes: A61B 50/30 : Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 8/10 : Eye inspection
• CPC Class Codes: A61F 2/24 : Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2/246 : Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2463 : Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 : Delivery devices therefor
• CPC Class Codes: A61M 2025/0161 : wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 25/0136 : Handles therefor
• CPC Class Codes: A61M 25/0138 : having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

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 device for engaging tissue 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 an inverted position wherein the engagement surfaces face away from each other; and

an actuation mechanism coupled to the fixation elements adapted to move the fixation elements between the closed position and the inverted position.

2. A fixation device as in claim 1, wherein the fixation elements are further moveable to an open position between the closed position and the inverted position.

3. A fixation device as in claim 2, wherein in the open position the engagement surface of one fixation element forms an angle of more than about 5°

and less than about 90°

with the engagement surface of the other fixation element.

4. A fixation device as in claim 2 wherein in the open position the engagement surface of one fixation element forms an angle of more than about 90°

and less than about 180°

with the engagement surface of the other fixation element.

5. A fixation device as in claim 1 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.

6. A fixation device as in claim 5, wherein the gripping elements have frictional features configured to enhance grip on tissue engaged thereby.

7. A fixation device as in claim 5 wherein the gripping elements are movable independently of the fixation elements.

8. A fixation device as in claim 5 wherein the gripping elements are biased toward the engagement surfaces.

9. A fixation device as in claim 5 wherein the gripping elements are movable from an undeployed configuration in which each gripping element is separated from an opposing engagement surface, to a deployed configuration in which the gripping element is adjacent to the opposing engagement surface.

10. A fixation device as in claim 9 wherein each fixation element is at least partially concave and each gripping element is at least partially recessed within the fixation element in the deployed configuration.

11. A fixation device as in claim 9 wherein the gripping elements are approximately parallel to each other in the undeployed configuration.

12. A fixation device as in claim 1 wherein the actuation mechanism comprises a pair of link members coupled to the first and second fixation elements whereby moving the link members moves the first and second fixation elements.

13. A fixation device as in claim 12 wherein the actuation mechanism further comprises a coupling member and a stud slidably coupled to the coupling member, the first ends being coupled to one of either the coupling member or the stud, and the link members being coupled to the other of either the coupling member or the stud.

14. A fixation device as in claim 13 wherein the link members are connected to one of either the coupling member or the stud by a hinge.

15. A fixation device as in claim 13 wherein the link members are connected to the fixation elements by a hinge.

16. A fixation device as in claim 1, further comprising a locking mechanism adapted to lock the fixation elements in a desired position.

17. A fixation device as in claim 16 wherein the actuation mechanism comprises a movable stud coupled to the fixation elements, the locking mechanism being configured to frictionally engage the stud to prevent movement thereof.

18. A fixation device as in claim 17 wherein the locking mechanism comprises a wedging element for frictionally engaging the stud.

19. A fixation device as in claim 18 further comprising a coupling member having a pair of sidewalls, at least one of the sidewalls sloping toward the other sidewall, the stud being slideable between the sidewalls, the wedging element being movably disposed between the stud and at least one sidewall.

20. A fixation device as in claim 19 wherein the wedging element comprises a rolling element configured to roll along the at least one sidewall in engagement with the stud.

21. The fixation device of claim 20 wherein the rolling element comprises a barbell having a pair of generally cylindrical caps and a shaft therebetween, the shaft being configured to engage the stud between the caps.

22. The fixation device of claim 16 further comprising an unlocking mechanism adapted to unlock the fixation elements so as to be movable from the desired position.

23. The fixation device of claim 16 further comprising an unlocking mechanism adapted to unlock the fixation elements so as to be movable from the desired position, the unlocking mechanism comprising a harness coupled to the wedging element, the harness adapted to move the wedging element to reduce frictional engagement of the stud.

24. The fixation device of claim 1 further comprising a coupling member for detachably coupling the fixation device to a delivery device.

25. The fixation device of claim 24 wherein the coupling member comprises an outer member having an axial channel, the outer member being coupled to one of either the fixation elements or the actuation mechanism, and an inner member extending slidably through the axial channel and coupled to the other of either the fixation elements or the actuation mechanism.

26. The fixation device of claim 25 wherein outer member has a mating surface for engagement with the delivery device, the mating surface having a sigmoid shape.

27. The fixation device of claim 1 further comprising a covering on the fixation elements adapted for promoting tissue growth.

28. The fixation device of claim 1 further comprising a coating on the fixation elements adapted for delivering a therapeutic agent.

29. A fixation device as in claim 1 wherein the fixation elements have longitudinal edges between the first end and the free end, the longitudinal edges being curved about a longitudinal axis away from the engagement surfaces.

30. A fixation device as in claim 1 wherein the free ends of the fixation elements curve away from the engagement surfaces about a transverse axis generally parallel to the engagement surface.

31. A fixation device as in claim 30 wherein the free ends of the fixation elements are curved about a second access not parallel to the transverse axis.

32. A fixation device for engaging tissue 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 an open position wherein the free ends are spaced apart and a closed position wherein the free ends are closer together with the engagement surfaces generally facing each other;

a locking mechanism coupled to the fixation elements for locking the engagement elements in the closed position; and

an unlocking mechanism for disengaging the locking mechanism so the fixation elements are movable to the open position.

33. A fixation device as in claim 32 further comprising a movable stud coupled to the fixation elements, the locking mechanism being configured to frictionally engage the stud to prevent movement thereof.

34. A fixation device as in claim 32 wherein the locking mechanism comprises a wedging element for frictionally engaging the stud.

35. A fixation device as in claim 34 further comprising a coupling member having a pair of sidewalls, at least one of the sidewalls sloping toward the other sidewall, the stud being slideable between the sidewalls, the wedging element being movably disposed between the stud and the at least one sidewall.

36. A fixation device as in claim 35 wherein the wedging element comprises a rolling element configured to roll along the at least one sidewall in engagement with the stud.

37. The fixation device of claim 36 wherein the rolling element comprises a barbell having a pair of generally cylindrical caps and a shaft therebetween, the shaft being configured to engage the stud between the caps.

38. The fixation device of claim 34 wherein the unlocking mechanism comprising a harness coupled to the wedging element, the harness adapted to move the wedging element to reduce frictional engagement of the stud.

39. The fixation device of claim 32 further comprising an actuation mechanism coupled to the fixation elements for moving the fixation elements from the open position to the closed position.

40. The fixation device of claim 39 wherein the locking mechanism engages the actuation mechanism to lock the fixation elements.

41. The fixation device of claim 40 wherein the actuation mechanism comprises a coupling member and a stud slidably coupled the coupling member, the first ends being coupled to one of either the coupling member or the stud, the locking mechanism being configured to frictionally engage the stud.

42. The fixation device of claim 41 wherein the unlocking mechanism is movably coupled to the coupling member and configured to disengage the locking mechanism from the stud.

43. The fixation device of claim 32 wherein the fixation elements are further movable to an inverted position in which the engagement surfaces are facing generally away from each other.

44. The fixation device of claim 32 further comprising a pair of gripping elements movably coupled to the fixation elements, each gripping element being movable toward and away from the engagement surface of a fixation element.

45. A fixation device for engaging tissue 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 an open position wherein the free ends are spaced apart and a closed position wherein are the free ends are closer together and the engagement surfaces are generally facing each other;

a pair of gripping elements coupled to the fixation elements, each gripping element being movable toward and away from the engagement surface of a fixation element; and

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

46. The fixation device of claim 45 wherein the gripping elements are movable independently of the fixation elements.

47. The fixation device of claim 45 wherein each gripping element is biased toward the engagement surface of a fixation element.

48. The fixation device of claim 45 wherein the gripping elements are flexible so as to be deflectable toward and away from the engagement surfaces.

49. The fixation device of claim 45 wherein the gripping elements are movable from an undeployed position in which each gripping element is separated from an opposing engagement surface, to a deployed position in which the gripping element is adjacent to the opposing engagement surface.

50. The fixation device of claim 49 further comprising a deployment member for moving the gripping elements between the deployed and undeployed positions.

51. The fixation device of claim 45 wherein the gripping elements are movable independently of each other.

52. The fixation device of claim 45 wherein each gripping element has a contact surface for contacting tissue, the contact surface comprising grip-enhancing elements configured to engage the tissue.

53. The fixation device of claim 52 wherein the grip-enhancing elements are selected from prongs, windings, bands, barbs, grooves, channels, bumps, surface roughening, sintering, pads, coverings, and coatings.

54. The fixation device of claim 45 further comprising a cover over at least part of the gripping elements, the cover being adapted to promote tissue growth.

55. The fixation device of claim 45 further comprising a cover over at least part of the fixation elements, the cover being adapted to promote tissue growth.

56. A fixation device as in claim 45 wherein the actuation mechanism comprises a pair of link members coupled to the first and second fixation elements whereby moving the link members moves the first and second fixation elements.

57. A fixation device as in claim 56 wherein the actuation mechanism further comprises a coupling member and a stud slidably coupled the coupling member, the first ends being coupled to one of either the coupling member or the stud, and the link members being coupled to the other of either the coupling member or the stud.

58. A method of performing a therapeutic intervention at a tissue site comprising:

advancing an interventional tool having a proximal end, a distal end and a fixation device near the distal end to a location within a body, wherein the fixation device includes a pair of fixation elements each having a free end and an engagement surface;

moving the fixation elements to an open position wherein the free ends are separated and the engagement surfaces face generally proximally;

positioning the fixation elements such that the engagement surfaces engage tissue at the tissue site; and

inverting the fixation elements to an inverted position wherein the engagement surfaces face generally away from each other.

59. The method of claim 58 further comprising, after the step of positioning, moving the fixation elements toward each other so that the free ends are closer together and engagement surfaces are generally facing each other so as to engage the tissue with the engagement surface.

60. The method of claim 59, wherein the tissue comprises first and second leaflets, the step of moving the fixation elements comprising coapting the leaflets.

61. The method of claim 58 further comprising deploying a gripping element on the fixation device toward each engagement surface so as to capture tissue therebetween.

62. The method of claim 61 further comprising retracting the gripping element from the engagement surface before the step of inverting.

63. The method of claim 58 wherein the step of advancing comprises inserting the fixation device through a valve annulus and the tissue comprises a valve leaflet.

64. The method of claim 63, further comprising withdrawing the fixation device through the valve annulus with the fixation elements in the inverted position.

65. The method of claim 63, wherein the advancing step comprises passing the fixation device from an atrium of the heart into a ventricle of the heart.

66. The method of claim 63 wherein the advancing step comprises passing the fixation device through a ventricle of the heart into an atrium of the heart.

67. The method of claim 58, further comprising after the step of positioning, locking the fixation elements in a desired position.

68. The method of claim 58, further comprising after the step of positioning, releasing the fixation device from the interventional tool.

69. A fixation device for engaging tissue comprising:

a coupling member configured for coupling with a catheter; and

a pair of distal elements connected to the coupling member each distal element having an engagement surface for engaging the tissue, wherein the distal elements are moveable between an open position wherein the distal elements extend radially outwardly facing the engagement surfaces toward a first direction, and an inverted position wherein the distal elements have rotated away from the first direction facing the engagement surfaces radially outwardly.

70. A fixation device as in claim 69, wherein these distal elements are moveable to a closed position wherein the distal elements have rotated toward the first direction facing the engagement surfaces toward each other so that the distal elements are parallel to each other.

71. A fixation device as in claim 70, further comprising an actuation mechanism rotatably connected to the distal elements, wherein movement of the actuation mechanism moves the distal elements between the positions.

72. A fixation device as in claim 71, wherein the actuation mechanism comprises a spring.

73. A fixation device as in claim 72, wherein the spring holds the engagement surfaces in engagement with the tissue.

74. A fixation device as in claim 72, wherein the spring holds the distal elements in the inverted position.

75. A fixation device as in claim 71, wherein the actuation mechanism and distal elements are comprised of one molded part.

76. A fixation device as in claim 71, wherein the actuation mechanism is adapted for attachment to an actuator rod so that movement of the actuator rod and the attached actuation mechanism away from the first direction moves the distal elements toward to the inverted position.

77. A fixation device as in claim 76, wherein movement of the actuator rod and attached actuation mechanism toward the first direction moves the distal elements toward the closed position.

78. A fixation device as in claim 71, wherein the actuation mechanism comprises a pair of legs, each leg rotatably attached to a distal element.

79. A fixation device as in claim 69, further comprising a locking mechanism which locks the distal elements in place.

80. A fixation device as in claim 79, wherein the locking mechanism prevents movement of the actuation mechanism.

81. A fixation device as in claim 80, further comprising a stud fixedly attached to the actuation mechanism and disposed between the distal elements.

82. A fixation device as in claim 81, wherein the locking mechanism includes a release harness wherein applying tension to the release harness unlocks the locking mechanism.

83. A fixation device as in claim 82, wherein the locking mechanism further comprises at least one barbell, wherein applying tension to the release harness unwedges the at least one barbell from against the stud.

84. A fixation device as in claim 83, wherein the locking mechanism further comprises a spring, wherein the spring wedges the at least one barbell against the stud upon releasing tension from the release harness thereby locking the locking mechanism.

85. A fixation device as in claim 81, wherein the locking mechanism includes a folded leaf structure having a hole through which the stud passes, wherein tilting the folded leaf structure creates friction between the hole and the stud locking the locking mechanism.

86. A fixation device as in claim 69, further comprising proximal elements connected to the coupling member configured for engaging the tissue between the proximal and distal elements.

87. A fixation device as in claim 86, wherein the proximal elements have frictional accessories selected from the group consisting of prongs, windings, bands, barbs, or a combination of these.

88. A fixation device as in claim 86, wherein the proximal elements and distal elements include magnets which assist in holding the tissue therebetween by magnetic force.

89. A fixation device as in claim 86, wherein each distal element has a cupped shape and each proximal element is positionable to be at least partially recessed within the cupped distal element.

90. A fixation device as in claim 89, wherein each proximal element is angled to increase recession within the cupped distal element along the length of the distal element.

91. A fixation device as in claim 69, wherein the engagement surface includes prongs, barbs, serrations, magnets or a combination of these.

92. A fixation device as in claim 91, wherein each distal element further includes a bumper extending over the engagement surface.

93. A fixation device as in claim 69, wherein the fixation device is sized for passage through a catheter.

94. A fixation device as in claim 93, wherein the fixation device is sized for passage through a catheter in the inverted position.

95. A fixation device as in claim 69, further comprising a covering which covers at least a portion of the distal elements, wherein the covering has a fabric, mesh, weave, felt, looped or porous structure.

96. A fixation device as in claim 95, wherein the covering further includes drugs, antibiotics, anti-thrombosis agents, anti-platelet agents or a combination of these.

97. A fixation device for engaging tissue, said device comprising:

a coupling member configured for coupling with a catheter;

a pair of opposed distal elements, each distal element having an engagement surface facing the opposed distal element, wherein the distal elements are rotatably connected to the coupling member to the tissue; and

a locking mechanism capable of locking the distal elements in place and then unlocking the distal elements to allow rotation of the distal elements about the coupling member.

98. A fixation device as in claim 97, wherein the distal elements comprise elongate arms, each arm having a proximal end rotatably connected to the coupling member and a free end.

99. A fixation device as in claim 98, wherein the engagement surfaces are disposed on the free ends.

100. A fixation device as in claim 99, wherein the distal elements are rotatable so that the engagement surfaces are positioned up to approximately 180 degrees apart relative to the coupling member.

101. A fixation device as in claim 98, further comprising a pair of extension arms, each extension arm rotatably connecting the proximal end of the each distal element to the coupling member, and wherein the extension arms are capable of translating the proximal ends of the arms away from the coupling member.

102. A fixation device as in claim 101, wherein the extension arms are capable of independently translating the proximal ends of the distal elements away from the coupling member.

103. A fixation device as in claim 101, wherein the extension arms are capable of holding the distal elements in parallel with each other while providing a gap between the distal elements and the coupling member.

104. A fixation device as in claim 97, wherein the locking mechanism comprises an actuation mechanism, rotatably connected to the distal elements, wherein the actuation mechanism comprises a spring which holds the distal elements in engagement with the tissue.

105. A fixation device as in claim 97, wherein at least one engagement surface comprises a sawtooth surface.

106. A fixation device as in claim 97, wherein at least one engagement surface comprises a least one barb.

107. A fixation device as in claim 106, wherein each distal element further comprises a bumper facing the opposed distal element, the bumpers configured to hold the portion of the tissue so that the at least one barb is contactable with the tissue through the bumpers.

108. A fixation device as in claim 97, further comprising a pair of proximal elements connected to the coupling member configured to allow positioning of tissue between a proximal element and a distal element.

109. A fixation device as in claim 108, wherein the proximal elements are retractable.

110. A fixation device as in claim 108, wherein the proximal elements have a loop shape.

111. A method comprising:

advancing a catheter having a proximal end, a distal end and a fixation device near the distal end to a location within a body, wherein the fixation device includes a pair of distal elements each having an engagement surface;

moving the distal elements to an open position wherein the distal elements extend radially outwardly facing the engagement surfaces toward a direction other than radially outwardly; and

moving the distal elements to an inverted position wherein the engagement surfaces face radially outwardly.

112. The method of claim 111, wherein the distal elements are in a closed position wherein the engagement surfaces face each other while the catheter is advanced to the location.

113. The method of claim 112, further comprising engaging the engagement surfaces of the fixation device in the open position against at least one tissue.

114. The method of claim 113, wherein the at least one tissue comprises two tissues to be approximated and further comprising transitioning the fixation device from the open position toward the closed position grasping the tissues between the engagement surfaces thereby approximating the tissues.

115. The method of claim 114, wherein the fixation device is coupled to the catheter by a coupling member, and further comprising decoupling the fixation device from the catheter.

116. A method as in claim 115, wherein the catheter includes a tether attaching the fixation device to the catheter and further comprising retrieving the decoupled fixation device with the use of the tether.

117. The method of claim 113, wherein the direction is toward the proximal end of the catheter and wherein the fixation device comprises proximal elements disposed proximally of the distal elements, and further comprising grasping the at least one tissue between the proximal and distal elements.

118. The method of claim 111, further comprising advancing an introducer to a location near the at least one tissue and wherein advancing the catheter comprises advancing the catheter through the introducer.

119. The method of claim 118, wherein the at least one tissue comprises two valve leaflets of a valve and wherein the location resides within a heart.

120. The method of claim 119, wherein the direction is toward the proximal end of the catheter and wherein advancing the catheter comprises passing the fixation device through an atrium and the valve having the two valve leaflets and engaging comprises engaging the engagement surfaces against ventricular surfaces of the leaflets.

121. A method as in claim 119, wherein the direction is toward the distal end of the catheter and wherein advancing the catheter comprises passing the fixation device through a ventricle and engaging the engagement surfaces against ventricular surfaces of the two valve leaflets.

122. The method of claim 120 or 121, wherein engaging the leaflets comprises holding the leaflets in a coapted arrangement.

123. A method as in claim 122, further comprising evaluating regurgitation of blood flow through the valve.

124. A method as in claim 123, further comprising unlocking the distal elements to allow movement of the distal elements.

125. A method for fixing tissues together comprising:

advancing a catheter having a proximal end, a distal end and a fixation device disposed near the distal end to a location near the tissues, wherein the fixation device includes a pair of distal elements each having a removable implant pledget;

moving the distal elements so that each implant pledget engages one of the tissues;

penetrating each tissue and engaged implant pledget and passing a tie therethrough;

fastening the ties to fix the tissues together; and

removing the fixation device leaving the implant pledget in place.

126. The method of claim 125, wherein the catheter includes at least one fixation tool which penetrates each tissue.

127. The method of claim 125, further comprising deploying an anchor attached to the tie so that the anchor rests against the implant pledget while the tie passes through the implant pledget.

128. The method of claim 125, wherein moving the distal elements so that each implant pledget engages one of the tissues comprises moving the distal elements to an open position where the distal elements project radially outwardly.

129. The method of claim 128, wherein the fixation device comprises an actuator rod wherein axial movement of the actuator rod transitions the distal ends between the open position and an inverted position wherein the distal elements are directed distally.

130. The method of claim 129, wherein the fixation device further comprises deployment arms attached to the actuator so that retraction of the actuator rod pushes the deployment arms against the distal elements to move the distal elements from the inverted position to the open position.

131. A system comprising:

a catheter having a proximal end and a distal end, the catheter configured to pass from remote vasculature of a patient to a location within the patient'"'"'s body near a tissue;

a fixation device removably coupleable to the distal end and having a pair of distal elements, each distal element having an engagement surface for engaging the tissue, wherein the distal elements are moveable between an open position wherein the distal elements extend radially outwardly facing the engagement surfaces toward a first direction, and an inverted position wherein the distal elements have rotated away from the first direction facing the engagement surfaces radially outwardly.

132. A system as in claim 131, wherein the fixation device further comprises proximal elements configured for engaging the tissue between the proximal and distal elements.

133. A system as in claim 132, wherein each distal element has a cupped shape and each proximal element is positionable to be at least partially recessed within the cupped distal element.

134. A system as in claim 131, wherein the distal elements are moveable between a closed position wherein the engagement surfaces face one another and the open position.

135. A system as in claim 131, further comprising an introducer configured to pass from the remote vasculature of the patient to the location within the patient'"'"'s body wherein the catheter and fixation device are configured for passage through the introducer.

136. A fixation device as in claim 131, wherein the device further comprises a covering which covers at least a portion of the distal elements, wherein the covering has a fabric, mesh, weave, felt, looped or porous structure.

137. A catheter for engaging tissues comprising:

a catheter shaft having a distal end; and

a fixation device disposed near the distal end of the catheter shaft comprising

a shaft having a proximal end and a distal end, and

a pair of fixation elements each movably coupled to the distal end of the shaft and positionable in an open position where the fixation elements project generally radially outward from the shaft, each fixation element having an implant pledget removably attached thereto.

138. An interventional catheter as in claim 137, wherein the fixation elements are positionable in an inverted position where the fixation elements are directed generally distally.

139. An interventional catheter as in claim 138, further comprising an actuator rod slidably coupled to the shaft, wherein axial movement of the actuator rod transitions the fixation elements between the open and inverted positions.

140. A catheter as in claim 138, wherein the fixation device further comprises deployment arms attached to the actuator rod and the fixation elements so that axial movement of the rod moves the fixation elements between the inverted position and the open position.

141. A catheter as in claim 137 comprising a pair of fixation tools each extendable from the catheter toward one of the fixation elements so as to penetrate through tissue and the implant pledget.

142. A catheter as in claim 141, wherein each fixation tool is adapted for passing a suture through the penetrated implant pledget for suturing the implant pledgets together.

143. A catheter as in claim 142, wherein the fixation tool is adapted for passing an anchor through the penetrated implant pledget and deploying the anchor.

144. A system comprising:

a catheter having an elongated shaft, a proximal end and a distal end, the catheter configured to pass from remote vasculature of a patient to a location within the patient'"'"'s body near a tissue; and

a fixation device removably coupled to the distal end and having a pair of fixation elements, each fixation element having a free end and an engagement surface for engaging the tissue, wherein the fixation elements are moveable between an open position wherein the free ends are spaced apart and the engagement surfaces face generally proximally, and an inverted position wherein the engagement surfaces face generally away from each other.

145. A system as in claim 144, wherein the fixation device further comprises gripping elements movable relative to the fixation elements for capturing tissue therebetween.

146. A system as in claim 145, wherein each fixation element is at least partially concave and each gripping element is positionable to be at least partially recessed within the concave fixation element.

147. A system as in claim 144, wherein the fixation elements are further moveable to a closed position wherein the free ends are closer together and the engagement surfaces generally face one another.

148. A system as in claim 144, further comprising an introducer configured to pass from the remote vasculature of the patient to the location within the patient'"'"'s body wherein the catheter and fixation device are configured for passage through the introducer.

149. A system as in claim 144, wherein the device further comprises a covering which covers at least a portion of the fixation elements, the covering being configured to promote tissue growth.

150. An interventional system comprising:

a tubular guide having a proximal end, a distal end and a channel therebetween, the distal end of the tubular guide being deflectable about a first axis;

a delivery catheter positionable through the channel, the delivery catheter having a flexible shaft with a proximal end, a distal end, a lumen therebetween, and an actuation element movably disposed in the lumen; and

a fixation device having a coupling member releasably coupled to the distal end of the shaft, a first fixation element movably coupled to the coupling member, and a first gripping element movable relative to the fixation element, the first fixation element being releasable coupled to the actuation element and movable therewith, the first fixation element and the first gripping element being adapted to engage tissue therebetween.

151. The interventional system of claim 150 wherein the fixation device comprises a second fixation element movably coupled to the coupling member and a second gripping element movable relative to the second fixation element.

152. The interventional system of claim 151 wherein the first and second fixation elements are movable toward and away from each other.

153. The interventional system of claim 150 further comprising a gripper line movably disposed in the lumen of the shaft, the gripping element being releasably coupled to the gripper line and being movable therewith.

154. The interventional system of claim 150 wherein the fixation device further comprises a locking mechanism adapted to lock the fixation element in position relative to the coupling member.

155. The interventional system of claim 154 wherein the fixation device further comprises an unlocking mechanism for releasing the locking mechanism, and wherein a lock line is movably disposed in the lumen in the shaft, the unlocking mechanism being releasably coupled to the lock line and movable therewith.

157. The interventional system of claim 150 wherein the fixation element has an engagement surface for engaging tissue, the fixation element being movable from a first position wherein the fixation element is disposed less than about 90 degrees relative to a longitudinal axis of the shaft, to a second position wherein the fixation element is disposed more than 90 degrees relative to the longitudinal axis of the shaft.

158. The interventional system of claim 157 wherein the first and second positions are at least about 90 degrees apart.

159. The interventional system of claim 158 wherein the first position is about parallel to the longitudinal axis of the shaft.

160. The interventional system of claim 150 wherein the fixation element and the gripping element are configured to a traumatically engage tissue therebetween.

161. The interventional system of claim 150 wherein the tubular guide, the delivery catheter and the fixation device are endovascularly positionable through a blood vessel.

162. The interventional system of claim 150 wherein the fixation element is positionable in a patient'"'"'s heart, the fixation element and the gripping element being configured to engage a valve leaflet.

156. The interventional system of claim 156 wherein the tubular guide is deflectable about a second axis generally perpendicular to the first axis.

163. A fixation device for fixing a pair of tissue flaps each having an upper surface and a lower surface, the fixation device comprising:

a coupling member adapted for being held by a delivery device;

first and second fixation elements movably coupled to the coupling member, the fixation elements having engagement surfaces for engaging the downstream surfaces of the tissue flaps,

first and second gripping elements movable relative to the fixation elements and each having tissue gripping surfaces in opposition to an engagement surface of the fixation elements for engaging an upstream surface of a tissue flap so as to hold the tissue flap between the gripping element and the fixation element; and

an actuation mechanism for moving the first and second fixation elements from an open position in which the first and second fixation elements are disposed apart toward a closed position wherein the upstream surfaces of the tissue flaps generally face each other.

164. The fixation device of claim 163 wherein the fixation elements are generally rigid.

165. The fixation device of claim 163 wherein the gripping elements are flexible.

166. The fixation device of claim 163 wherein the fixation elements are rotatably coupled to the coupling member and the actuation mechanism is configured to rotate the fixation elements about the coupling member.

167. The fixation device of claim 166 wherein the engagement surfaces of the first and second fixation elements are disposed at an angle of about 90 to 180 degrees relative to each other in the open position.

168. A method of fixing a pair of tissue flaps each having an upstream surface and a downstream surface, the method comprising:

engaging a first downstream surface of a first tissue flap with an engagement surface of a first fixation element;

engaging a second downstream surface of a second tissue flap with an engagement surface of a second fixation element;

gripping a first upstream surface of the first tissue flap with a gripping surface of a first gripping element to hold the first tissue flap between the first fixation element and the first gripping element;

gripping a second upstream surface of the second tissue flap with a gripping surface of a second gripping element to hold the second tissue flap between the second fixation element and the second gripping element;

moving the first fixation element toward the second fixation element so that the first tissue flap is positioned closer to the second tissue flap and the upstream surfaces are generally facing each other; and

locking the first and second fixation elements in a position.

169. The method of claim 168 wherein the upstream surfaces are engaging each other in the position.

170. The method of claim 168 wherein the gripping elements are engaging each other in the position.

171. The method of claim 168 wherein the engagement surfaces of the first and second fixation elements are facing each other in the position.

172. The method of claim 168 wherein the tissue flaps comprise leaflets of a heart valve.

173. The method of claim 172 further comprising positioning the first and second fixation elements and first and second gripping elements through a blood vessel into the heart.

174. The method of claim 172 wherein blood flows through the heart valve in a flow direction, the upstream surfaces of the leaflets being generally parallel to the flow direction in the position.

175. The method of claim 168 wherein the first and second tissue flaps are located in a body cavity, the method further comprising permanently implanting the first and second fixation elements and the first and second gripping elements in the body cavity.