Apparatus and methods for manipulating and securing tissue

• US 20050251162A1
• Filed: 09/29/2004
• Published: 11/10/2005
• Est. Priority Date: 05/07/2004
• Status: Active Grant

• Current Assignee: USGI Medical, Inc.
• Original Assignee: USGI Medical, Inc.
• Inventors: Saadat, Vahid, Ewers, Richard C., Lam, Cang C., Michlitsch, Kenneth J., Rothe, Chris
• Granted Patent: US 7,347,863 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• CPC Class Codes: A61B 1/0014 Fastening element for attaching accessories to the outside of an endoscope, e.g. clips, clamps or bands
• 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 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/295 combined with cutting implements
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/00876 magnetic
• 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 2017/0496 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 2017/06076 helically or spirally coiled
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter

Abstract

Apparatus and methods for manipulating and securing tissue are described herein. In creating tissue folds within the body of a patient, a tissue manipulation assembly may generally have an elongate tubular member, an engagement member slidably disposed through the tubular member and a distal end adapted to engage tissue via a helical member, tissue stabilizing members positioned at the tubular member distal end which are adapted to stabilize tissue therebetween, and a delivery tube pivotable about the tissue stabilizer. The stabilizing members can be adapted to become angled relative to a longitudinal axis of the elongate tubular member. Moreover, one or all the articulation controls and functions can be integrated into a singular handle assembly connectable to the tissue manipulation assembly via a rigid or flexible tubular body.

Claims

1. An apparatus for forming a tissue fold, comprising:

an elongate tubular member having a proximal end, a distal end, and a length therebetween;

an engagement member having a distal end adapted to engage tissue;

a first stabilizing member and a second stabilizing member positioned at the tubular member distal end and adapted to stabilize tissue therebetween, wherein the first and second stabilizing members are further adapted to be angled relative to a longitudinal axis of the elongate tubular member; and

a delivery tube adapted to pivot about the first stabilizing member.

2. The apparatus of claim 1 further comprising a needle assembly slidably disposed within the delivery tube.

3. The apparatus of claim 2 further comprising an elongate hollow member connected to the needle assembly and disposed within the delivery tube.

4. The apparatus of claim 3 further comprising an elongate pusher slidably disposed within the elongate hollow member.

5. The apparatus of claim 2 further comprising at least one expandable anchor slidably disposed within the needle assembly for securement against the tissue fold.

6. The apparatus of claim 5 further comprising a length of suture attached to the anchor for securement through the tissue fold.

7. The apparatus of claim 2 wherein the needle assembly is adapted to be advanced from the delivery tube perpendicular to the first or second stabilizing member.

8. The apparatus of claim 2 wherein the needle assembly is adapted to be advanced from the delivery tube at an angle relative to the first or second stabilizing member.

9. The apparatus of claim 2 wherein the needle assembly comprises a cross-section which is keyed to a corresponding cross-section of the delivery tube.

10. The apparatus of claim 2 wherein the cross-section of the needle assembly is selected from the group consisting of circles, ellipses, rectangles, hexagons, heptagons, and octagons.

11. The apparatus of claim 2 wherein a portion of the needle assembly is keyed to the delivery tube for maintaining an orientation of the needle assembly relative to the delivery tube.

12. The apparatus of claim 2 wherein the needle assembly comprises a needle body having a sharpened distal end.

13. The apparatus of claim 12 wherein the needle body is hollow.

14. The apparatus of claim 12 wherein the needle body is curved.

15. The apparatus of claim 13 wherein the needle body is comprised of a shape memory alloy.

16. The apparatus of claim 12 wherein the needle body is adapted to vibrate while piercing into or through tissue.

17. The apparatus of claim 16 further comprises a piezoelectric transducer adapted to vibrate the needle body.

18. The apparatus of claim 12 wherein the needle body is adapted to be torqued via a proximal end of the needle body.

19. The apparatus of claim 18 wherein the needle body is threaded over an outer surface.

20. The apparatus of claim 12 wherein the needle body defines a plurality of dimples over an outer surface.

21. The apparatus of claim 2 wherein the needle assembly further comprises a lubricious layer or coating disposed over an inner and/or outer surface of the needle assembly.

22. The apparatus of claim 2 wherein the needle assembly further comprises a lubricious layer or coating disposed over an inner surface of the needle assembly.

23. The apparatus of claim 2 wherein the needle assembly defines an opening along an outer surface proximally of a distal end of the needle assembly through which at least one expandable anchor is slidably disposed for securement against the tissue fold.

24. The apparatus of claim 2 wherein the needle assembly comprises a piercing wire extending distally from a tapered needle body configured to dilate tissue.

25. The apparatus of claim 2 wherein the needle assembly is colored with a color selected from the group consisting of red, orange, yellow, green, blue, indigo, violet, silver, black, and combinations thereof.

26. The apparatus of claim 2 further comprising an anvil positioned adjacent to the needle assembly and adapted to direct a needle being advanced from the delivery tube into a curved or angled path.

27. The apparatus of claim 2 wherein the needle assembly comprises a fiber optic member having a sharpened distal tip.

28. The apparatus of claim 27 further comprising a processor for processing visual data received from the fiber optic tissue piercing member.

29. The apparatus of claim 28 further comprising a visual display in electrical or optical communication with the fiber optic member.

30. The apparatus of claim 2 wherein the needle assembly comprises a needle body having a piercing tip and a grasping arm positioned proximally of the tip, the grasping arm being adapted to project from the needle body and releasably retain a length of suture.

31. The apparatus of claim 1 wherein the elongate tubular member comprises a flexible length.

32. The apparatus of claim 31 wherein the flexible length is adapted to be advanced through an endoscopic device.

33. The apparatus of claim 32 wherein the endoscopic device comprises a shape-lockable endoscopic body.

34. The apparatus of claim 32 wherein the endoscopic device is steerable.

35. The apparatus of claim 1 wherein the elongate tubular member comprises a rigid length.

36. The apparatus of claim 1 wherein the distal end of the engagement member comprises a helically-wound member configured to pierce the tissue when rotated about its longitudinal axis.

37. The apparatus of claim 36 wherein the helically-wound member defines a uniform pitch.

38. The apparatus of claim 36 wherein the helically-wound member defines a non-uniform pitch.

39. The apparatus of claim 36 wherein the helically-wound member comprises a second helically-wound member.

40. The apparatus of claim 36 wherein the helically-wound member defines a tapered outer diameter.

41. The apparatus of claim 36 wherein the distal end of the engagement member further comprises a needle extending distally through the helically-wound member.

42. The apparatus of claim 36 further comprising a pair of opposable grasping jaws positioned about the helically-wound member.

43. The apparatus of claim 36 further comprising at least one tissue anchor disposed within the helically-wound member.

44. The apparatus of claim 1 wherein the engagement member is slidably disposed through the tubular member.

45. The apparatus of claim 1 further comprising a sheath for receiving the engagement member therewithin.

46. The apparatus of claim 45 wherein the sheath is longitudinally slidable relative to the engagement member.

47. The apparatus of claim 1 further comprising an atraumatic insert configured to be advanced within the engagement member.

48. The apparatus of claim 1 wherein the distal end of the engagement member is adapted to be electrically charged.

49. The apparatus of claim 48 further comprising a power generator in electrical communication with the distal end of the engagement member.

50. The apparatus of claim 1 further comprising a linear bearing slidably connected to the stabilizing member.

51. The apparatus of claim 50 wherein the linear bearing is slidably connected to the engagement member.

52. The apparatus of claim 51 wherein the linear bearing is adapted to slide along the first stabilizing member when the engagement member is advanced distally or proximally relative to the first stabilizing member.

53. The apparatus of claim 1 wherein the stabilizing member defines an opening or channel.

54. The apparatus of claim 1 wherein the first and the second stabilizing members are positioned adjacent to one another such that a tissue receiving channel is defined therebetween.

55. The apparatus of claim 1 wherein the second stabilizing member is pivotable relative to the first stabilizing member.

56. The apparatus of claim 1 wherein the second stabilizing member is adapted to pivot into a closed configuration relative to the first stabilizing member upon a linear bearing being advanced proximally over the first stabilizing member.

57. The apparatus of claim 1 wherein the first or second stabilizing member is biased towards one another.

58. The apparatus of claim 57 wherein the first or second stabilizing member is urged into an open configuration relative to one another upon a linear bearing being advanced distally over the first stabilizing member.

59. The apparatus of claim 1 wherein the first and second stabilizing members are articulatable relative to one another via a linkage assembly.

60. The apparatus of claim 1 wherein the first or second stabilizing member is adapted to be urged away from one another.

61. The apparatus of claim 1 wherein the first stabilizing member is adapted to be urged towards the second stabilizing member upon the delivery tube being pivoted about the first stabilizing member.

62. The apparatus of claim 1 wherein a length of the second stabilizing member is greater than a length of the first stabilizing member.

63. The apparatus of claim 1 wherein the first and second stabilizing members each comprise an atraumatic distal end.

64. The apparatus of claim 1 wherein the second stabilizing member defines a split opening therethrough.

65. The apparatus of claim 64 wherein the split opening is defined via two articulatable arms.

66. The apparatus of claim 1 wherein the first or second stabilizing member is adapted to be electrically charged.

67. The apparatus of claim 66 further comprising a power generator in electrical communication with the first or second stabilizing member.

68. The apparatus of claim 1 wherein the delivery tube is colored with a color selected from the group consisting of red, orange, yellow, green, blue, indigo, violet, silver, black, and combinations thereof.

69. An apparatus for forming a tissue fold, comprising:

an elongate tubular member having a proximal end, a distal end, and a flexible length therebetween;

a helically-wound engagement member adapted to engage tissue and slidably disposed through the tubular member;

a first stabilizing member and a second stabilizing member positioned at the tubular member distal end and adapted to stabilize tissue therebetween, wherein the first and second stabilizing members are further adapted to be angled relative to a longitudinal axis of the elongate tubular member;

a delivery tube adapted to pivot about the first stabilizing member; and

a needle assembly having a needle body slidably disposed within the delivery tube.

70. The apparatus of claim 69 further comprising an elongate hollow member connected to the needle assembly and disposed within the delivery tube.

71. The apparatus of claim 70 further comprising an elongate pusher slidably disposed within the elongate hollow member.

72. The apparatus of claim 69 further comprising at least one expandable anchor slidably disposed within the needle assembly for securement against the tissue fold.

73. The apparatus of claim 72 further comprising a length of suture attached to the anchor for securement through the tissue fold.

74. The apparatus of claim 69 wherein the needle body comprises a cross-section which is keyed to a corresponding cross-section of the delivery tube.

75. The apparatus of claim 69 wherein the needle body is hollow.

76. The apparatus of claim 69 wherein the needle body is curved.

77. The apparatus of claim 69 wherein the needle body is adapted to vibrate while piercing into or through tissue.

78. The apparatus of claim 77 further comprises a piezoelectric transducer adapted to vibrate the needle body.

79. The apparatus of claim 69 further comprising an endoscopic device through which the elongate tubular member is adapted to be advanced.

80. The apparatus of claim 79 wherein the endoscopic device comprises a shape-lockable endoscopic body.

81. The apparatus of claim 79 wherein the endoscopic device is steerable.

82. The apparatus of claim 69 wherein the helically-wound member defines a uniform pitch.

83. The apparatus of claim 69 wherein the helically-wound member defines a non-uniform pitch.

84. The apparatus of claim 69 wherein the helically-wound member comprises a second helically-wound member.

85. The apparatus of claim 69 wherein the helically-wound member defines a tapered outer diameter.

86. The apparatus of claim 69 wherein the distal end of the engagement member further comprises a needle extending distally through the helically-wound member.

87. The apparatus of claim 69 further comprising a pair of opposable grasping jaws positioned about the helically-wound member.

88. The apparatus of claim 69 further comprising a sheath for receiving the engagement member therewithin.

89. The apparatus of claim 88 wherein the sheath is longitudinally slidable relative to the engagement member.

90. The apparatus of claim 69 further comprising an atraumatic insert configured to be advanced within the engagement member.

91. The apparatus of claim 69 further comprising a power generator in electrical communication with the distal end of the engagement member.

92. The apparatus of claim 69 further comprising a linear bearing slidably connected to the stabilizing member.

93. The apparatus of claim 92 wherein the linear bearing is slidably connected to the engagement member.

94. The apparatus of claim 93 wherein the linear bearing is adapted to slide along the first stabilizing member when the engagement member is advanced distally or proximally relative to the first stabilizing member.

95. The apparatus of claim 69 wherein the stabilizing member defines an opening or channel.

96. The apparatus of claim 69 wherein the first and the second stabilizing members are positioned adjacent to one another such that a tissue receiving channel is defined therebetween.

97. The apparatus of claim 69 wherein the second stabilizing member is pivotable relative to the first stabilizing member.

98. The apparatus of claim 69 wherein the second stabilizing member is adapted to pivot into a closed configuration relative to the first stabilizing member upon a linear bearing being advanced proximally over the first stabilizing member.

99. The apparatus of claim 69 wherein the first or second stabilizing member is biased towards one another.

100. The apparatus of claim 99 wherein the first or second stabilizing member is urged into an open configuration relative to one another upon a linear bearing being advanced distally over the first stabilizing member.

101. The apparatus of claim 69 further comprising a power generator in electrical communication with the first or second stabilizing member.

102. A method for forming a tissue fold, comprising:

positioning an elongate tubular member adjacent to a region of tissue to be plicated;

advancing an engagement member slidably disposed through the tubular member and having a distal end adapted to engage the region of tissue thereto;

engaging the region of tissue with the engagement member distal end; and

proximally withdrawing engaged tissue between a first stabilizing member and a second stabilizing member at an angle relative to a longitudinal axis of the tubular member; and

securing the engaged tissue.

103. The method of claim 102 wherein positioning an elongate tubular member comprises advancing the tubular member transorally.

104. The method of claim 102 wherein positioning an elongate tubular member comprises advancing the tubular member percutaneously.

105. The method of claim 102 wherein positioning an elongate tubular member comprises advancing the tubular member through an endoscopic device.

106. The method of claim 105 further comprising shape-locking the endoscopic device prior to or after advancing the tubular member therethrough.

107. The method of claim 105 further comprising steering the endoscopic device.

108. The method of claim 102 wherein positioning an elongate tubular member comprises advancing a rigid tubular member to the region of tissue.

109. The method of claim 102 wherein advancing an engagement member comprises pushing a proximal end of the engagement member to advance the engagement member through the tubular member.

110. The method of claim 102 further comprising angling the first and second stabilizing members relative to the longitudinal axis of the tubular member prior to securing the engaged tissue.

111. The method of claim 102 wherein engaging the region of tissue comprises rotating a helically-wound member about its longitudinal axis such that the tissue is engaged to the helically-wound member.

112. The method of claim 111 further comprising advancing a sheath over the helically-wound member.

113. The method of claim 111 further comprising advancing an atraumatic insert within the helically-wound member.

114. The method of claim 102 further comprising pivoting the first and/or second stabilizing members relative to one another.

115. The method of claim 114 further comprising proximally advancing a linear bearing over the first stabilizing member such that the second stabilizing member is pivoted into a closed configuration relative to the first stabilizing member.

116. The method of claim 102 further comprising biasing the first and/or second stabilizing members towards one another prior to securing the engaged tissue.

117. The method of claim 114 further comprising actuating a linkage assembly such that the first and/or second stabilizing members pivot relative to one another.

118. The method of claim 102 further comprising pivoting a distal portion of a delivery tubular member relative to the elongate tubular member prior to securing the engaged tissue.

119. The method of claim 118 wherein the distal portion of the delivery tubular member is pivoted perpendicularly relative to the elongate tubular member.

120. The method of claim 118 further comprising advancing a needle body through the delivery tubular member such that the needle body passes through the engaged tissue.

121. The method of claim 120 further comprising deploying at least one anchor from the needle body for securement against the tissue.

122. The method of claim 121 wherein securing the engaged tissue comprises securely drawing the at least one anchor against the tissue.

123. The method of claim 120 wherein advancing a needle body through the delivery tubular member comprises vibrating the needle body while piercing into or through the tissue.

124. The method of claim 120 wherein advancing a needle body through the delivery tubular member comprises directing the needle body into a curved or angled path relative to the delivery tubular member.

125. The method of claim 102 further comprising electrically charging the first and/or second stabilizing member prior to securing the engaged tissue.

126. The method of claim 102 further comprising electrically charging the first and/or second stabilizing member after securing the engaged tissue.