Apparatus and methods for positioning and securing anchors

• US 20050251157A1
• Filed: 05/07/2004
• Published: 11/10/2005
• Est. Priority Date: 05/07/2004
• Status: Active Grant

• Current Assignee: USGI Medical, Inc., USGI Medical Incorporated
• Original Assignee: USGI Medical, Inc.
• Inventors: Elmers, Marvin C., Saadat, Vahid, Ewers, Richard C., Maahs, Tracy D., Flores, Jesus, Lam, Cang C., Peh, Ruey-Feng, Khairkhahan, Alex
• Granted Patent: US 8,308,765 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• 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 17/0401 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 17/0487 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 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• 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 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0446 Means for attaching and blocking the suture in the suture anchor
• CPC Class Codes: A61B 2017/045 snug fit within the anchor
• CPC Class Codes: A61B 2017/0451 Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0456 : Surface features on the anchor, e.g. ribs increasing friction between the suture and the anchor
• CPC Class Codes: A61B 2017/0458 : Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0459 : Multiple holes in the anchor through which the suture extends and locking the suture when tension is applied
• CPC Class Codes: A61B 2017/0461 : with features cooperating with special features on the suture, e.g. protrusions on the suture
• CPC Class Codes: A61B 2017/0462 : One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/0475 : using sutures having a slip knot
• CPC Class Codes: A61B 2017/0477 : with pre-tied sutures
• CPC Class Codes: A61B 2017/0488 : Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06028 : by means of a cylindrical longitudinal blind bore machined at the suture-receiving end of the needle, e.g. opposite to needle tip
• 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 hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/06176 : with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/081 : Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 2017/3488 : Fixation to inner organ or inner body tissue
• CPC Class Codes: Y10T 24/39 : Cord and rope holders
• CPC Class Codes: Y10T 24/3936 : Pivoted part
• CPC Class Codes: Y10T 24/3969 : Sliding part or wedge

Abstract

Apparatus and methods for positioning and securing anchors are disclosed herein. The anchors are adapted to be delivered and implanted into or upon tissue, particularly tissue within the gastrointestinal system of a patient. The anchor is adapted to slide uni-directionally over suture such that a tissue plication may be cinched between anchors. A locking mechanism either within the anchor itself of positioned proximally of the anchor may allow for the uni-directional translation while enabling the anchor to be locked onto the suture if the anchor is pulled, pushed, or otherwise urged in the opposite direction along the suture. This unidirectional anchor locking mechanism facilitates the cinching of the tissue plication between the anchors and it may be utilized in one or several anchors in cinching a tissue fold.

Claims

1. An anchor for implantation in a body, comprising:

an anchor body adapted to be delivered through a hollow member for placement against a tissue surface; and

a locking mechanism adapted to pass the anchor body in a first direction relative to a flexible member upon application of a cinching force, wherein the locking mechanism is further adapted to impart a locking force upon the flexible member when the anchor body is urged in a second direction opposite to the first direction, and wherein the locking force is greater than the cinching force.

2. The anchor of claim 1 wherein the anchor body comprises a T-anchor.

3. The anchor of claim 2 wherein the T-anchor has a cross-sectional shape selected from the group consisting of circles, rectangles, and squares.

4. The anchor of claim 1 wherein the anchor body comprises a basket anchor.

5. The anchor of claim 4 wherein the basket anchor is reconfigurable from a delivery configuration within the hollow member to an expanded configuration outside the hollow member.

6. The anchor of claim 1 wherein the hollow member is selected from the group consisting of tubular members, catheters, needles, and trocars.

7. The anchor of claim 1 wherein the flexible member comprises a length of suture.

8. The anchor of claim 7 wherein the suture comprises a plurality of knots or protrusions along the length of the suture.

9. The anchor of claim 8 wherein the knots or protrusions are formed at regular intervals along the length.

10. The anchor of claim 8 wherein the knots or protrusions are formed intermittently along the length.

11. The anchor of claim 7 wherein the length of suture comprises a monofilament, multifilament, elastic, or elastomeric material.

12. The anchor of claim 7 wherein the length of suture comprises a metallic material.

13. The anchor of claim 12 wherein the metallic material is selected from the group consisting of Nitinol, stainless steel, and Titanium.

14. The anchor of claim 7 wherein at least a portion of the length of suture is surrounded by a material having a frictional coefficient higher than the suture.

15. The anchor of claim 14 wherein the material comprises a metal coating or sleeve.

16. The anchor of claim 1 wherein the locking mechanism comprises a locking block slidably disposed within the anchor body and adapted to be urged against the flexible member.

17. The anchor of claim 16 wherein the locking block is urged via a spring against the flexible member.

18. The anchor of claim 16 wherein the locking mechanism comprises a second locking block slidably disposed within the anchor body and adapted to be urged in a direction opposite to the locking block.

19. The anchor of claim 16 wherein the locking block defines a groove for contacting the flexible member.

20. The anchor of claim 1 wherein the anchor body defines a tapered opening for passage of the flexible member therethrough.

21. The anchor of claim 1 wherein the locking mechanism comprises at least one biased lever adjacent to an opening defined in the anchor body.

22. The anchor of claim 1 wherein the locking mechanism is contained within the anchor body.

23. The anchor of claim 1 wherein the locking mechanism is in-line with the flexible member.

24. The anchor of claim 1 wherein the locking mechanism is adapted to automatically impart the locking force upon the flexible member.

25. The anchor of claim 1 wherein the locking mechanism comprises a knot adapted to slide distally along the flexible member.

26. The anchor of claim 25 wherein the knot is located proximally of the anchor body.

27. The anchor of claim 25 wherein the knot is looped about the anchor body.

28. The anchor of claim 1 wherein the locking mechanism comprises a collet defining a lumen for passage of the flexible member therethrough and having a plurality of locking arms at a distal end of the collet, the collet being sized for advancement into a proximal portion of the anchor body.

29. The anchor of claim 28 wherein the locking arms are adapted to be cinched upon the flexible member when the collet is advanced into the anchor body.

30. The anchor of claim 1 wherein the locking mechanism comprises at least one pin adapted to be advanced into a proximal portion of the anchor body such that the pin wedges against the flexible member.

31. The anchor of claim 30 wherein the pin is tapered.

32. The anchor of claim 30 wherein the locking mechanism further comprises at least one retractable arm pivotally attached to the pin for withdrawing the pin from the anchor body.

33. The anchor of claim 30 wherein the pin defines a contact surface adapted to cinch upon the flexible member.

34. The anchor of claim 1 wherein the locking mechanism comprises at least one tab biased to cinch against a portion of the flexible member passed through the anchor body.

35. The anchor of claim 34 wherein the locking mechanism further comprises a tapered member defining a lumen for passage of the flexible member therethrough, the tapered member being adapted to be advanced into the anchor body for releasing the flexible member when the tapered member is positioned against the tab.

36. The anchor of claim 1 wherein the locking mechanism comprises at least one arm biased to project into a lumen defined through the anchor body and to cinch the flexible member against a surface of the lumen.

37. The anchor of claim 36 wherein the arm is further adapted to release the flexible member when the anchor body is advanced distally.

38. The anchor of claim 1 wherein the locking mechanism comprises at least one arm biased to project at an angle proximally of the anchor body.

39. The anchor of claim 38 wherein the arm defines a tapered opening through which the flexible member is passed.

40. The anchor of claim 38 wherein the arm is integral with the anchor body.

41. The anchor of claim 1 wherein the locking mechanism comprises a second flexible member looped about the flexible member within the anchor body such that insertion of the looped second flexible member in a proximal portion of the anchor body imparts the locking force.

42. The anchor of claim 1 wherein the locking mechanism comprises a sleeve which defines a tortuous passageway for passage of the flexible member therethrough.

43. The anchor of claim 42 wherein the sleeve is located proximally of the anchor body.

44. The anchor of claim 42 wherein the sleeve is integral with the anchor body.

45. The anchor of claim 42 wherein the tortuous passageway is defined by at least one obstruction integral with the sleeve such that the obstruction protrudes into a lumen of the sleeve.

46. The anchor of claim 45 wherein the at least one obstruction comprises a lever adapted to protrude partially into the lumen.

47. The anchor of claim 1 wherein the locking mechanism comprises a sleeve adapted to reconfigure into a crimped configuration.

48. The anchor of claim 1 wherein the anchor further comprises a protective sleeve disposed between the flexible member and the anchor body, the sleeve defining a lumen through which the flexible member is passed.

49. The anchor of claim 1 wherein a proximal collar of the anchor body defines a plurality of openings over a surface of the collar for placement against a portion of the flexible member.

50. The anchor of claim 1 wherein the locking mechanism comprises an electrically conductive inner sleeve and a deformable outer sleeve, the inner sleeve defining a plurality of openings over its surface and a lumen through which the flexible member is passed.

80. The anchor of claim 1 wherein the locking mechanism comprises at least one arm biased to project at an angle proximally of the second anchor body.

81. The anchor of claim 80 wherein the arm defines a tapered opening through which the flexible member is passed.

82. The anchor of claim 80 wherein the arm is integral with the second anchor body.

51. An anchor system for implantation in a body, comprising:

a first anchor body adapted to be delivered through a hollow member for placement against a first region of tissue surface;

a second anchor body adapted to be delivered through the hollow member for placement against a second region of tissue surface;

a flexible member extending between the first anchor body and the second anchor body, wherein the second anchor body comprises a locking mechanism adapted to allow the second anchor body to pass in a distal direction relative to the suture upon application of a cinching force on the second anchor body, and wherein the locking mechanism is adapted to impart a locking force upon the flexible member when the second anchor body is urged in a proximal direction.

52. The anchor of claim 51 wherein the first anchor body and second anchor body are selected from the group consisting of T-anchors, basket anchors, and combinations thereof.

53. The anchor of claim 51 wherein the hollow member is selected from the group consisting of tubular members, catheters, needles, and trocars.

54. The anchor of claim 51 wherein the flexible member comprises a length of suture.

55. The anchor of claim 54 wherein the suture comprises a plurality of knots or protrusions along the length of the suture.

56. The anchor of claim 55 wherein the knots or protrusions are formed at regular intervals along the length.

57. The anchor of claim 55 wherein the knots or protrusions are formed intermittently along the length.

58. The anchor of claim 54 wherein the length of suture comprises a monofilament, multifilament, elastic, or elastomeric material.

59. The anchor of claim 54 wherein the length of suture comprises a metallic material.

60. The anchor of claim 59 wherein the metallic material is selected from the group consisting of Nitinol, stainless steel, and Titanium.

61. The anchor of claim 54 wherein at least a portion of the length of suture is surrounded by a material having a frictional coefficient higher than the suture.

62. The anchor of claim 61 wherein the material comprises a metal coating or sleeve.

63. The anchor of claim 51 wherein the locking mechanism comprises at least one biased lever adjacent to an opening defined in the second anchor body.

64. The anchor of claim 51 wherein the locking mechanism is contained within the second anchor body.

65. The anchor of claim 51 wherein the locking mechanism is in-line with the flexible member.

66. The anchor of claim 51 wherein the locking mechanism is adapted to automatically impart the locking force upon the flexible member.

67. The anchor of claim 51 wherein the locking mechanism comprises a knot adapted to slide distally along the flexible member.

68. The anchor of claim 67 wherein the knot is located proximally of the second anchor body.

69. The anchor of claim 67 wherein the knot is looped about the second anchor body.

70. The anchor of claim 51 wherein the locking mechanism comprises a collet defining a lumen for passage of the flexible member therethrough and having a plurality of locking arms at a distal end of the collet, the collet being sized for advancement into a proximal portion of the second anchor body.

71. The anchor of claim 70 wherein the locking arms are adapted to be cinched upon the flexible member when the collet is advanced into the second anchor body.

72. The anchor of claim 51 wherein the locking mechanism comprises at least one pin adapted to be advanced into a proximal portion of the second anchor body such that the pin wedges against the flexible member.

73. The anchor of claim 72 wherein the pin is tapered.

74. The anchor of claim 72 wherein the locking mechanism further comprises at least one retractable arm pivotally attached to the pin for withdrawing the pin from the second anchor body.

75. The anchor of claim 72 wherein the pin defines a contact surface adapted to cinch upon the flexible member.

76. The anchor of claim 51 wherein the locking mechanism comprises at least one tab biased to cinch against a portion of the flexible member passed through the second anchor body.

77. The anchor of claim 76 wherein the locking mechanism further comprises a tapered member defining a lumen for passage of the flexible member therethrough, the tapered member being adapted to be advanced into the second anchor body for releasing the flexible member when the tapered member is positioned against the tab.

78. The anchor of claim 51 wherein the locking mechanism comprises at least one arm biased to project into a lumen defined through the second anchor body and to cinch the flexible member against a surface of the lumen.

79. The anchor of claim 78 wherein the arm is further adapted to release the flexible member when the second anchor body is advanced distally.

83. The anchor of claim 51 wherein the locking mechanism comprises a sleeve which defines a tortuous passageway for passage of the flexible member therethrough.

84. The anchor of claim 83 wherein the sleeve is located proximally of the second anchor body.

85. The anchor of claim 83 wherein the sleeve is integral with the second anchor body.

86. The anchor of claim 83 wherein the tortuous passageway is defined by at least one obstruction integral with the sleeve such that the obstruction protrudes into a lumen of the sleeve.

87. The anchor of claim 86 wherein the at least one obstruction comprises a lever adapted to protrude partially into the lumen.

88. A tissue cinching system, comprising:

an elongate member having at least a portion which is hollow;

at least one anchor body adapted to be delivered through the hollow portion of the elongate member and placed against a surface of tissue;

a locking mechanism adapted to allow the anchor body to pass in a distal direction relative to the suture upon application of a cinching force on the anchor body; and

a flexible member for passage through the anchor body.

89. The anchor of claim 88 wherein the anchor body are selected from the group consisting of T-anchors, basket anchors, and combinations thereof.

90. The anchor of claim 88 wherein the elongate member is selected from the group consisting of tubular members, catheters, needles, and trocars.

91. The anchor of claim 88 wherein the flexible member comprises a length of suture.

92. The anchor of claim 91 wherein the suture comprises a plurality of knots or protrusions along the length of the suture.

93. The anchor of claim 92 wherein the knots or protrusions are formed at regular intervals along the length.

94. The anchor of claim 92 wherein the knots or protrusions are formed intermittently along the length.

95. The anchor of claim 91 wherein the length of suture comprises a monofilament, multifilament, elastic, or elastomeric material.

96. The anchor of claim 91 wherein the length of suture comprises a monofilament, multifilament, elastic, or elastomeric material.

97. The anchor of claim 96 wherein the metallic material is selected from the group consisting of Nitinol, stainless steel, and Titanium.

98. The anchor of claim 91 wherein at least a portion of the length of suture is surrounded by a material having a frictional coefficient higher than the suture.

99. The anchor of claim 91 wherein the material comprises a metal coating or sleeve.

100. The anchor of claim 88 wherein the locking mechanism comprises at least one biased lever adjacent to an opening defined in the anchor body.

101. The anchor of claim 88 wherein the locking mechanism is contained within the anchor body.

102. The anchor of claim 88 wherein the locking mechanism is in-line with the flexible member.

103. The anchor of claim 88 wherein the locking mechanism is adapted to automatically impart the locking force upon the flexible member.

104. A method for cinching an anchor relative to tissue, comprising:

ejecting an anchor body from a hollow member in proximity to the tissue;

urging the anchor body distally along a flexible member into contact against a surface of the tissue to be cinched; and

locking the anchor body with a self-locking mechanism adapted to allow the anchor body to pass distally over the suture while preventing the anchor body from moving proximally over the flexible member.

105. The method of claim 104 wherein ejecting an anchor body comprises urging the anchor body from an opening defined at a distal end of the hollow member.

106. The method of claim 104 wherein urging the anchor body distally comprises pushing the anchor body via the hollow member.

107. The method of claim 104 wherein urging the anchor body distally comprises pushing the anchor body via an elongate push rod.

108. The method of claim 104 wherein urging the anchor body distally comprises urging the anchor body along a length of suture.

109. The method of claim 104 wherein locking the anchor body with a self-locking mechanism comprises inhibiting proximal movement of the anchor body over the flexible member via a locking block disposed within the anchor body.

110. The method of claim 104 wherein locking the anchor body with a self-locking mechanism comprises inhibiting proximal movement of the anchor body over the flexible member via at least one biased lever adjacent to an opening defined in the anchor body.

111. The method of claim 104 wherein locking the anchor body with a self-locking mechanism comprises sliding a knot with the anchor body distally along the flexible member.

112. The method of claim 104 wherein locking the anchor body with a self-locking mechanism comprises advancing a collet into the anchor body to cinch a plurality of locking arms at a distal end of the collet onto the flexible member.

113. The method of claim 104 wherein locking the anchor body with a self-locking mechanism comprises advancing a pin into the anchor body to cinch the flexible member against a portion of the anchor body.

114. The method of claim 113 further comprising withdrawing the pin from the anchor body to release the flexible member via at least one retractable arm pivotally attached to the pin.

115. The method of claim 104 wherein locking the anchor body with a self-locking mechanism comprises cinching the flexible member against a portion of the anchor body via at least one biased tab.

116. The method of claim 104 wherein locking the anchor body with a self-locking mechanism comprises cinching the flexible member within an opening defined through at least one biased arm.

117. The method of claim 104 wherein locking the anchor body with a self-locking mechanism comprises cinching the flexible member within an opening defined through at least one arm biased to project at an angle proximally of the anchor body.

118. The method of claim 104 wherein locking the anchor body with a self-locking mechanism comprises drawing a looped portion of a second flexible member within an opening of the anchor body to impart the locking force against the flexible member.

119. The method of claim 104 wherein locking the anchor body with a self-locking mechanism comprises passing the flexible member through a tortuous passageway proximally of the anchor body.

120. A method for delivering a cinching anchor to a region of tissue to be cinched, comprising:

ejecting an anchor body in proximity to a tissue surface to be cinched from a hollow member such that the anchor body reconfigures from a delivery configuration to a deployed configuration;

urging the anchor body distally along a flexible member into contact against the tissue surface; and

locking the anchor body with a locking mechanism adapted to allow the anchor body to pass distally over the flexible member while preventing the anchor body from moving proximally over the flexible member.

121. The method of claim 120 wherein ejecting an anchor body comprises urging the anchor body from an opening defined at a distal end of the hollow member.

122. The method of claim 120 wherein urging the anchor body distally comprises pushing the anchor body via the hollow member.

123. The method of claim 120 wherein urging the anchor body distally comprises pushing the anchor body via an elongate push rod.

124. The method of claim 120 wherein urging the anchor body distally comprises urging the anchor body along a length of suture.

125. The method of claim 120 wherein locking the anchor body with a self-locking mechanism comprises inhibiting proximal movement of the anchor body over the flexible member via a locking block disposed within the anchor body.

126. The method of claim 120 wherein locking the anchor body with a self-locking mechanism comprises inhibiting proximal movement of the anchor body over the flexible member via at least one biased lever adjacent to an opening defined in the anchor body.

127. The method of claim 120 wherein locking the anchor body with a locking mechanism comprises sliding a knot with the anchor body distally along the flexible member.

128. The method of claim 120 wherein locking the anchor body with a locking mechanism comprises advancing a collet into the anchor body to cinch a plurality of locking arms at a distal end of the collet onto the flexible member.

129. The method of claim 120 wherein locking the anchor body with a locking mechanism comprises advancing a pin into the anchor body to cinch the flexible member against a portion of the anchor body.

130. The method of claim 129 further comprising withdrawing the pin from the anchor body to release the flexible member via at least one retractable arm pivotally attached to the pin.

131. The method of claim 120 wherein locking the anchor body with a locking mechanism comprises cinching the flexible member against a portion of the anchor body via at least one biased tab.

132. The method of claim 120 wherein locking the anchor body with a locking mechanism comprises cinching the flexible member within an opening defined through at least one biased arm.

133. The method of claim 120 wherein locking the anchor body with a locking mechanism comprises cinching the flexible member within an opening defined through at least one arm biased to project at an angle proximally of the anchor body.

134. The method of claim 120 wherein locking the anchor body with a locking mechanism comprises drawing a looped portion of a second flexible member within an opening of the anchor body to impart the locking force against the flexible member.

135. The method of claim 120 wherein locking the anchor body with a locking mechanism comprises passing the flexible member through a tortuous passageway proximally of the anchor body.