Left atrial appendage devices and methods

• US 20050149069A1
• Filed: 11/12/2004
• Published: 07/07/2005
• Est. Priority Date: 12/04/2001
• Status: Abandoned Application

• Current Assignee: Atricure, Inc.
• Original Assignee: Atricure, Inc.
• Inventors: Geyster, Steve, Bertolero, Arthur A., Ibrahim, Tamer
• Application Number:
  US10/988,003
• Publication Number:
  US 20050149069A1
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61B 1/12 with cooling or rinsing arrangements
• 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 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof

Abstract

Devices and methods for clamping tissue and/or moving two tissue structures together by moving two plates or arm together. The pressure or force applied to the tissue may be used to bring the tissue together, to seal an opening or to cut through and remove a portion of the tissue. In one procedure disclosed, a clip applier may be used to apply one or more clips to the left atrial appendage of the heart to prevent clots from the left atrial appendage from embolizing and causing harm to the patient, such as a stroke.

Claims

1. A tissue clamping device for altering the configuration of tissue, the tissue clamping device comprising:

a first elongated plate having a first end and a second end,

a second elongated plate having a first end and a second end,

a first connector connecting said first end of said first elongated plate to said first end of said second elongated plate,

wherein said tissue clamping device has a first position and a second position,

and a locking mechanism for locking said tissue clamping device in said second position.

2. The tissue clamping device of claim 1, further comprising a second connector connecting said second end of said first elongated plate to said second end of said second elongated plate and an inflatable balloon attached to said first elongated plate.

3. The tissue clamping device of claim 2, wherein said balloon is filled with a material that changes phase to a solid.

4. The tissue clamping device of claim 2, wherein said balloon is filled with epoxy.

5. The tissue clamping device of claim 2, further comprising a fill tube extending from an end of said inflatable balloon.

6. The tissue clamping device of claim 2, further comprising a row of teeth extending from said second elongated plate along a longitudinal edge thereof, such that said row of teeth is located to extend beside a longitudinal edge of said inflatable balloon.

7. The tissue clamping device of claim 6, further comprising a second row of teeth extending from a second longitudinal edge of said second elongated plate, such that said second row of teeth is located to extend beside a second longitudinal edge of said inflatable balloon.

8. The tissue clamping device of claim 1, further comprising an arm extending from said second end of said second elongated plate, and wherein said locking mechanism includes a locking recess located in a post extending from said first elongated plate wherein a portion of said arm is sized and configured to fit within said locking recess, thereby holding said tissue clamping device in said second position.

9. The tissue clamping device of claim 1, wherein said second end of said second elongated plate is formed by a first arm and a second arm, said first and second arms being movable.

10. The tissue clamping device of claim 9, wherein said locking mechanism includes a first locking recess located in a first post extending from said first elongated plate and a second locking recess located in a second post extending from said first elongated plate and wherein a portion of said first arm is sized and configured to fit within said first locking recess and a portion of said second arm is sized and configured to fit within said second locking recess, thereby holding said tissue clamping device in said second position.

11. The tissue clamping device of claim 10, further comprising a first detent in said first arm and a second detent in said second arm, said first detent sized to engage a top portion of said first post and said second detent sized to engage a top portion of said second post.

12. The tissue clamping device of claim 9, wherein said first and second arms each having a hole proximate an end thereof.

13. An applier for applying the tissue clamping device of claim 12, comprising:

a movable arm having a first projection and a second projection sized and configured to engage the holes in the tissue clamping device of claim 12,

a clamp for releasably engaging a second end of said first elongated plate,

a first actuator for moving said movable arm,

and a second actuator for releasing said clamp from engagement with said second end of said first elongated plate.

14. The tissue clamping device of claim 1, wherein said first connector is a cable extending from said first elongated plate, through a first cable opening in said first end of said second elongated plate, through a second cable opening in said second end of said second elongated plate, and through a third cable opening in said second end of said first elongated plate.

15. The tissue clamping device of claim 14, wherein a first side of said cable has a plurality of cable teeth extending therefrom and said third cable opening has at least one locking tooth extending therefrom.

16. The tissue clamping device of claim 14, further comprising a tension limiter to limit a maximum tension on said cable.

17. An applier for applying the tissue clamping device of claim 14, comprising:

a first clamp for releasably gripping an end of said cable of the tissue clamping device of claim 14,

a second clamp for releasably engaging a second end of said first elongated plate

a first actuator for moving said first clamp, thereby moving said end of said cable,

and a second actuator for releasing said second clamp.

18. The tissue clamping device of claim 1, wherein said first elongated plate and said second elongated plate are curved and have similar curvatures.

19. The tissue clamping device of claim 1, wherein said first elongated plate and said second elongated plate are curved and have different curvatures.

20. The tissue clamping device of claim 1, wherein, when said tissue clamping device is in said second position, the first and second plates form an elongated opening tapering towards said first ends of said first and second elongated plates and towards said second ends of said first and second elongated plates.

21. The tissue clamping device of claim 1, wherein said first and second elongated plates have curvatures and said curvatures are selected to conform to a shape of the tissue.

22. The tissue clamping device of claim 1, wherein said first and second elongated plates have curvatures, wherein said first and second curvatures are selected such that, when said tissue clamping device is in said second position, said first ends of said first and second elongated plates touch, said second ends of said first and second elongated plates touch and a gap remains between a middle portion of said first elongated plate and a middle portion of said second elongated plate.

23. The tissue clamping device of claim 22, wherein said gap is oval, ovoid or oval-like.

24. The tissue clamping device of claim 1, wherein said tissue clamping device is configured to simultaneously move a first tissue structure and a second tissue structure together.

25. The tissue clamping device of claim 24, wherein said tissue clamping is further configured to apply sufficient compression to the two tissue structures such that contact between the first and second tissue structures is maintained under normal anatomical circulatory pressures of a patient.

26. The tissue clamping device of claim 1 used in combination with a tissue clamp applier having an applier shaft, wherein said first and second elongated plates are both moveable with respect to said applier shaft, wherein the motion of said first and second elongated plates is at a hinge.

27. The tissue clamping device of claim 26, wherein said hinge is a living hinge.

28. The tissue clamping device of claim 26, wherein said hinge is a pin hinge.

29. The tissue clamping device of claim 26, wherein the motion of said first and second elongated plates is created by a worm gear driven by said applier.

30. The tissue clamping device of claim 29, wherein said worm gear has a straight track.

31. The tissue clamping device of claim 29, wherein said worm gear has two inclined tracks.

32. The tissue clamping device of claim 26, wherein the motion of said first and second elongated plates is driven by mechanical advantage.

33. The tissue clamping device of claim 26, wherein the motion of said first and second elongated plates is driven by CO₂ pressure.

34. The tissue clamping device of claim 26, wherein the motion of said first and second elongated plates is driven by a vacuum pump.

35. The tissue clamping device of claim 26, wherein the motion of said first and second elongated plates is driven by AC or DC power.

36. The tissue clamping device of claim 1, wherein, when said tissue clamping device is in said first position, said first and second elongated plates are configured to enclosed a distal end of the tissue.

37. The tissue clamping device of claim 1, wherein, when said tissue clamping device is in said second position, said first and second elongated plates are configured to apply approximately evenly distributed forces along a longitudinal axis of the tissue clamping device.

38. The tissue clamping device of claim 1, further comprising a tissue fastener extending from one of said first and second elongated plates.

39. The tissue clamping device of claim 1, further comprising a plurality of tissue engaging projections extending from one of said first and second elongated plates.

40. The tissue clamping device of claim 1, further comprising a plurality of staples extending from one of said first and second elongated plates.

41. The tissue clamping device of claim 1, further comprising a suture extending from at least one of said first and second elongated plates.

42. The tissue clamping device of claim 1, further comprising at least one rivet.

43. The tissue clamping device of claim 1, further comprising at least one superelastic clip, said superelastic clip preformed to engage a selected portion of tissue.

44. The tissue clamping device of claim 1, further comprising a tissue cutter adjacent one of said first and second elongated plates.

45. The tissue clamping device of claim 1, wherein said tissue clamping device is formed of a resilient material, thereby continuing to apply direct pressure while in said second position.

46. The tissue clamping device of claim 1, further comprising a third position, wherein in said second position, said tissue clamping device is applying force to the tissue, and wherein said third is intermediate said first and second positions, such that said tissue clamping device is proximate the tissue, but is not applying force thereto.

47. The tissue clamping device of claim 1, further comprising a vacuum source connected to at least one of said first and second elongated plates.

48. The tissue clamping device of claim 1, further comprising an adhesive located on at least one of said first and second elongated plates.

49. The tissue clamping device of claim 1, further comprising an RF energy source connected to at least one of said first and second elongated plates, thereby allowing ablation of tissue.

50. The tissue clamping device of claim 1, further comprising an laser energy source connected to at least one of said first and second elongated plates, thereby allowing ablation of tissue.

51. The tissue clamping device of claim 1, further comprising a stabilizing arm extending from one of said first and second elongated plates.

52. The tissue clamping device of claim 1, further comprising a cartridge connectable with at least one of said first and second elongated plates, said cartridge holding a plurality of tissue fasteners.

53. The tissue clamping device of claim 52, wherein said plurality of tissue fasteners are staples.

54. The tissue clamping device of claim 1, further comprising a needle extending from one of said first and second elongated plates.

55. The tissue clamping device of claim 54, wherein said needle is connected to a suction source, said needle sized and configured to a clot to enter a distal tip of said needle and be withdrawn from a patient by said suction source.

56. A clip applier for applying at least one clip to a left atrial appendage of a heart of a patient, the device comprising:

an elongate shaft defining a proximal end and a distal end;

clip applying means coupled with the shaft at or near the distal end; and

an actuator coupled with the shaft at or near the distal end and also coupled with the clip applying means so as to actuate the applying means to apply the at least one clip to the left atrial appendage.

57. A clip applier as in claim 56, wherein the device is introducible through a lumen of a visualization device.

58. A clip applier as in claim 56, further including at least one clip coupled with the device in a position to allow the clip applying means to apply the clip to the atrial appendage.

59. A clip applier as in claim 58, wherein the at least one clip does not sever the atrial appendage when applied to the appendage by the clip applying means.

60. A tissue clamping device for altering the configuration of tissue, the tissue clamping device comprising:

a first elongated plate having a first end and a second end,

a second elongated plate having a first end and a second end, said first end of said second plate being connected with said first end of said first plate, and said second end of said second plate being connected with said second end of said second plate,

an inflatable membrane connected to said first plate,

wherein has a first, deflated position and a second, inflated position,

and a fill opening in fluid communication with an interior of said inflatable membrane.

61. The tissue clamping device of claim 60, further comprising a plurality of teeth extending from said second elongated plate.

62. The tissue clamping device of claim 61, wherein said plurality of teeth form a row along a longitudinal edge of said second elongated plate.

63. The tissue clamping device of claim 62, wherein said row of teeth is located to extend beside a longitudinal edge of said inflatable membrane.

64. The tissue clamping device of claim 61, wherein said plurality of teeth form a first row and a second row, said first row of teeth located along a first longitudinal edge of said second plate and said second row of teeth located along a second longitudinal edge of said second plate.

65. The tissue clamping device of claim 64, wherein said first row of teeth is located to extend beside a first longitudinal edge of said inflatable membrane and said second row of teeth is located to extend beside a second longitudinal edge of said inflatable membrane.

66. The tissue clamping device of claim 60, wherein said balloon is filled with a phase change material.

67. The tissue clamping device of claim 60, wherein said balloon is filled with epoxy.

68. The tissue clamping device of claim 60, further comprising a fill tube extending from said fill opening.

69. The tissue clamping device of claim 60, further comprising an RF energy source connected to at least one of said first and second elongated plates, thereby allowing ablation of tissue.

70. The tissue clamping device of claim 60, further comprising an laser energy source connected to at least one of said first and second elongated plates, thereby allowing ablation of tissue.

71. An applier for applying the tissue clamping device of claim 60, comprising:

a grip configured to engage an end of the tissue clamping device of claim 60,

an inflation solution source in fluid communication with said fill opening,

and a cutter for disconnecting said inflation solution source from said fill opening.

72. The applier of claim 71, wherein said cutter further comprises a crimper.

73. A tissue clamping device for altering the configuration of tissue, the tissue clamping device comprising:

a first elongated arm having a first end and a second end,

a second elongated arm having a first end and a second end, said first end of said second arm being connected with said first end of said first arm,

and a locking arm extending from said first elongated arm, said locking arm configured to engage an engagement portion of said second elongated arm,

said tissue clamping device having a first position and a second position, wherein, in said first position, said locking arm is separated from said second elongated arm, and in said second position, said locking arm engages said engagement portion of said second elongated arm.

74. The tissue clamping device of claim 73, wherein said second end of said second elongated plate is formed by a flexible arm, said first and second arms being movable and wherein said engagement portion is located on said flexible arm.

75. The tissue clamping device of claim 74, wherein said locking arm includes locking recess on a side thereof, and wherein a top surface of said locking recess engages said engagement portion of said flexible arm.

76. The tissue clamping device of claim 75, further comprising a first detent in said flexible arm and a second detent in said second arm, said first detent sized to engage said top portion of said locking recess.

77. The tissue clamping device of claim 75, further comprising a second locking arm extending from said first elongated arm, said second locking arm configured to engage a second engagement portion of said second elongated arm, said second locking arm including a second locking recess on a side thereof, and wherein said second end of said second elongated plate includes a second flexible arm extending generally parallel to the first flexible arm, and wherein a top surface of said second locking recess engages an engagement portion of said second flexible arm.

78. The tissue clamping device of claim 77, wherein said first and second arms each having a hole proximate an end thereof.

79. An applier for applying the tissue clamping device of claim 78, comprising:

a movable arm having a first projection and a second projection sized and configured to engage the holes in the tissue clamping device of claim 78,

a clamp for releasably engaging a second end of said first elongated plate,

a first actuator for moving said movable arm,

and a second actuator for releasing said clamp from engagement with said second end of said first elongated plate.

82. The tissue clamping device of claim 73, further comprising an RF energy source connected to at least one of said first and second elongated plates, thereby allowing ablation of tissue.

83. The tissue clamping device of claim 73, further comprising an laser energy source connected to at least one of said first and second elongated plates, thereby allowing ablation of tissue.

84. A tissue clamping device for altering the configuration of tissue, the tissue clamping device comprising:

a first elongated plate having a first end and a second end,

a second elongated plate having a first end and a second end,

a cable extending from said first elongated plate, through a first cable opening in said first end of said second elongated plate, through a second cable opening in said second end of said second elongated plate, and through a third cable opening in said second end of said first elongated plate,

wherein said tissue clamping device has a first position and a second position, and wherein said tissue clamping device is moved from said first position to said second position by pulling an end of said cable.

80. The tissue clamping device of claim 84, further comprising a plurality of projections extending from said first elongated plate.

81. The tissue clamping device of claim 80, wherein said projections have pointed tips.

85. The tissue clamping device of claim 84, wherein a first side of said cable has a plurality of cable teeth extending therefrom and said third cable opening has at least one locking tooth extending therefrom.

86. The tissue clamping device of claim 85, wherein said cable teeth and said locking tooth are sized and configured to allow the cable to move in a single direction through said third cable opening.

87. The tissue clamping device of claim 84, further comprising a plurality of projections extending from said first elongated plate.

88. The tissue clamping device of claim 87, wherein said projections are spikes.

89. The tissue clamping device of claim 84, further comprising a plurality of projections extending from said first elongated plate and said second elongated plate.

90. The tissue clamping device of claim 84, further comprising a tension limiter to limit a maximum tension on said cable.

91. The tissue clamping device of claim 84, further comprising an RF energy source connected to at least one of said first and second elongated plates, thereby allowing ablation of tissue.

92. The tissue clamping device of claim 84, further comprising an laser energy source connected to at least one of said first and second elongated plates, thereby allowing ablation of tissue.

93. An applier for applying the tissue clamping device of claim 84, comprising:

a first gripper for releasably gripping an end of said cable of said tissue clamping device of claim 84,

a second gripper for releasably engaging a second end of said first elongated plate

a first actuator for moving said first gripper, thereby moving said end of said cable,

and a second actuator for releasing said second gripper.

94. The applier of claim 93, wherein said second actuator also releases said first gripper.

95. The applier of claim 93, further comprising a third actuator for releasing said first gripper.

96. The applier of claim 93, wherein said first actuator is also used to release said first gripper.

97. A method of altering the natural proximity of two tissue structures, the method comprising the steps of:

(a) displacing a first and second tissue structure with a tissue clamping device;

(b) bringing the first tissue structure into contact with the second tissue structure;

(c) and applying sufficient pressure with the tissue clamping device to the first and second tissue structures such that intimate contact between the first and second tissue structures is maintained under normal anatomical circulatory pressures of the cardiovascular system.

98. The method of claim 97, wherein the tissue clamping device is left in place after surgery to continue to apply the sufficient pressure of step (c).

99. The method of claim 97, wherein the tissue clamping device is applied under direct visualization of the tissue structure.

100. The method of claim 97, wherein the tissue clamping device is applied to the left atrial appendage.

101. The method of claim 100, wherein the tissue clamping device is applied via a direct intercostal approach between ribs of a patient.

102. The method of claim 100, wherein the tissue clamping device is applied via a direct intercostal approach between the 4^th thru 6^th intercostals space.

103. The method of claim 97, wherein a tissue region adjacent to the tissue clamping device is dissected distal to the tissue clamping device.

104. The method of claim 97, further comprising the step of:

(d) manipulating at least one of the tissue structures prior to step (a).

105. The method of claim 104, wherein the manipulation of step (d) is performed by suction.

106. The method of claim 97, wherein step (a) is performed with the use of suction applied to a portion of the tissue clamping device.

107. The method of claim 97, wherein step (a) is performed with the use of a separate suction device.

108. The method of claim 97, wherein step (a) is performed by direct physical contact applying pressure on said first and second tissue structures.

109. The method of claim 108, wherein the direct pressure is provided by residual stress in a material used to create at least a portion of the tissue clamping device.

110. The method of claim 109, wherein the residual stress is caused by preforming the tissue clamping device into a shape prior performing steps (a) through (c).

111. The method claim of 109, further comprising the step of forming the tissue clamping device of a superelastic material.

112. The method of claim 108, further comprising the step of:

(d) locking the tissue clamping device in a closed position.

113. The method of claim 97, further comprising the step of:

(d) applying at least one staple to maintain the pressure of step (c).

114. The method of claim 97, further comprising the step of:

(d) applying at least one rivet to maintain the pressure of step (c).

115. The method of claim 97, further comprising the step of:

(d) applying at least one preformed clip formed of a superelastic material to maintain the pressure of step (c).

116. The method of claim 97, further comprising the step of:

(d) applying at least one suture to maintain the pressure of step (c).

117. The method of claim 97, further comprising the step of:

(d) applying RF energy to the tissue to maintain the contact between the first and second tissue structures of step (c).

118. The method of claim 97, further comprising the step of:

(d) applying an adhesive to maintain the pressure of step (c).

119. The method of claim 118, wherein the adhesive of step (d) is located on at least one elongated plate of the tissue clamping device.

120. The method of claim 97, further comprising the step of:

(d) applying laser energy to the tissue to maintain the contact between the first and second tissue structures of step (c).

121. The method of claim 97, wherein a device applicator is used to control the tissue clamping device.

122. The method of claim 121, wherein the tissue clamping device is decoupled from the device applicator once the tissue clamping device is fastened to at least one of the tissue structures in order to avoid transmitting large forces from the device applicator to the tissue structure, thereby avoiding causing damage to the tissue structure.

123. The method of claim 121, wherein the tissue clamping device is decouple from the device applicator prior to fastening the tissue clamping device to the tissue structures, thereby minimizing trauma to the tissue structures.

124. The method of claim 97, wherein the tissue structures are displaced simultaneously.

125. The method of claim 97, wherein the tissue structures are displaced sequentially.