Surgical suturing instrument and method of use

• US 7,131,979 B2
• Filed: 05/19/2003
• Issued: 11/07/2006
• Est. Priority Date: 05/17/2002
• Status: Active Grant

• Current Assignee: DVL Acquisition Sub, Inc. (Becton, Dickinson & Co)
• Original Assignee: DVL Acquisition Sub, Inc. (Becton, Dickinson & Co)
• Inventors: Sancoff, Gregory E., DiCarlo, Joseph A., Fogg, Douglas A., Field, Frederic P.
• Primary Examiner(s): ANDERSEN, MICHAEL T
• Application Number:
  US10/440,805
• Publication Number:
  US 20040254592A1
• Time in Patent Office: 1,268 Days
• Field of Search: 606/139, 606/144, 606/148
• US Class Current: 606/144
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• 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 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• 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 17/2909 Handles
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/06171 helically or spirally coiled for needles A61B2017/06076
• CPC Class Codes: A61B 2017/0646 for insertion into cartillege, e.g. meniscus
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/2929 with a head rotatable about the longitudinal axis of the shaft
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes

Abstract

A device is disclosed for introducing a flexible elongated element through at least two portions of a subject. The device includes an advancement unit for advancing the flexible elongated element toward the end of the device such that the elongated element may exit from the device with sufficient force to pass through the subject. The device also includes a curved die for imparting a looping configuration to portions of the flexible elongated element exiting the device, and a curved guide for receiving the looped flexible elongated element as it returns to the end of the device. A cutting mechanism is provided to permit the looped flexible elongated element to be separated from the remainder of the flexible elongated element. The cutting mechanism is adapted to deform the trailing end of the looped flexible elongated element so that the trailing end is forced distally, toward the subject being sutured.

Claims

1. A suturing instrument comprising:

a handle;

a shaft extending from the handle and having a proximal end and a distal end including an opening;

a first channel adapted to guide a suture wire in movement toward the opening;

a second channel extending from the first channel and shaped to impart a curvature to the suture wire as the suture wire moves in the second channel;

a cutter adapted to cut the suture wire; and

a wire drive located near the distal end of the shaft that is adapted to engage with and move the suture wire in the second channel;

wherein the suture wire forms a wire loop suture when moved out of the opening.

2. The instrument of claim 1, wherein the wire drive is adapted to engage with a side of the suture wire to move the suture wire in the second channel.

3. The instrument of claim 1, wherein the wire drive includes a cam and cam follower adapted to cooperate to engage the suture wire.

4. The instrument of claim 3, wherein the cam includes a body having a sloped surface and the cam follower includes a disc that is movable along the sloped surface to engage with the suture wire.

5. The instrument of claim 1, wherein the wire drive is located within the shaft.

6. The instrument of claim 1, wherein the wire drive includes an element adapted to engage with the suture wire to resist proximal movement of the suture wire.

7. The instrument of claim 6, wherein the element is adapted to engage with the suture wire to resist proximal movement of the suture wire when a portion of the wire drive moves proximally so as to re-engage the suture wire at a proximal position.

8. The instrument of claim 7, wherein the element is adapted to disengage from the suture wire when the portion of the wire drive re-engages with the suture wire to move the suture wire distally.

9. The instrument of claim 1, wherein the cutter includes a drive tube that extends along a portion of the shaft, and wherein the wire drive is at least partially located within the drive tube.

10. The instrument of claim 1, wherein the second channel and the opening are arranged so that the suture wire extends in a generally distal direction upon exiting the opening.

11. The instrument of claim 1, wherein when the wire drive moves the suture wire in the second channel, a free end of the suture wire moves from the opening and follows a curved path so that the free end moves back toward the instrument.

12. The instrument of claim 1, wherein the wire drive is adapted to move the suture wire from the opening with force sufficient so that a free end of the suture wire can penetrate tissue.

13. The instrument of claim 1, adapted to form an approximately circular wire loop suture by suture wire that is driven out of the opening in the distal end.

14. The instrument of claim 13, adapted to form the wire loop suture at an extreme axial end of the shaft.

15. The instrument of claim 1, wherein the cutter is adapted to cut the suture wire so as to form a sharp point on the suture wire.

16. The instrument of claim 15, wherein the cutter is adapted to cut the suture wire to free a length of the suture wire from the instrument after at least a portion of the length of suture wire has passed through the second channel.

17. The instrument of claim 1, wherein the cutter is adapted to cooperate with a portion of the second channel to cut the suture wire.

18. The instrument of claim 1, wherein the cutter includes a cutting surface adapted to move distally along the shaft to cut the suture wire.

19. The instrument of claim 1, wherein the cutter includes a cutting bar adapted to move distally to cut the suture wire.

20. The instrument of claim 1, wherein the cutter is adapted to cut the suture wire so that a formed wire loop suture is freed from suture wire remaining attached to the instrument.

21. The instrument of claim 1, wherein the wire drive is adapted to move the suture wire in an axial direction within the shaft.

22. The instrument of claim 1, wherein the second channel includes an “

S”

shaped portion with a convex portion and a concave portion.

23. The instrument of claim 22, wherein the cutter is adapted to cut the suture wire at a location between the convex portion and the concave portion.

24. The instrument of claim 1, further comprising:

a continuous length of suture wire, wherein the instrument is adapted to form a plurality of wire loop sutures from the continuous length of suture wire.

25. The instrument of claim 1, adapted for use in a minimally invasive surgical procedure.

26. The instrument of claim 1, wherein the distal end includes an angled end face.

27. The instrument of claim 26, arranged to form a wire loop suture in tissue by positioning the angled end face adjacent the tissue and driving the suture wire through the second channel such that a free end of the suture wire penetrates the tissue and follows a loop-like trajectory.

28. The instrument of claim 1, further comprising:

a recessed portion at the distal end, the recessed portion adapted to receive tissue or material to be sutured.

29. The instrument of claim 28, wherein the recessed portion includes a curved slot adapted to closely fit a portion of the suture wire that forms the wire loop suture.

30. The instrument of claim 29, wherein the curved slot includes a scalloped surface adapted to guide a free end of suture wire into the curved slot.

31. The instrument of claim 28, wherein the recessed portion includes a central slot and a pair of side recesses on opposite lateral sides of the central slot, and wherein the central slot is adapted to receive suture wire that is driven out of the opening to form the wire loop suture, and the pair of side recesses are adapted to receive portions of a pliable surface against which the distal end is placed.

32. The instrument of claim 1, adapted to form, with the suture wire that moves out of the opening, the wire loop suture in a spiral shape having a leading end that is adjacent to a trailing portion of the suture wire.

33. The instrument of claim 1, wherein the cutter is adapted to cut a trailing end of suture wire that forms the wire loop suture and to bend a portion of the trailing end inwardly toward a center of the loop.

34. A suturing instrument comprising:

a handle;

a shaft extending from the handle and having a proximal end and a distal end including an opening;

a first channel adapted to guide a suture wire in movement toward the opening;

a second channel extending from the first channel and shaped to impart a curvature to the suture wire as the suture wire moves in the second channel;

a cutter adapted to cut the suture wire; and

a wire drive including a cam and a cam follower arranged to cooperate to engage the suture wire, to move in a first direction to move the suture wire in the second channel, and to move in a second direction opposite the first direction, a portion of the wire drive biased toward engagement with the suture wire during movement in the second direction;

wherein the suture wire, when moved out of the opening, forms a wire loop suture.

35. The instrument of claim 34, wherein the wire drive is adapted to engage with a side of the suture wire to move the suture wire in the second channel.

36. The instrument of claim 34, wherein the cam follower is adapted to engage the suture wire.

37. The instrument of claim 36, wherein the cam includes a body having a sloped surface and the cam follower includes a disc that is movable along the sloped surface to engage with the suture wire.

38. The instrument of claim 34, wherein the cam and cam follower are located within the shaft.

39. The instrument of claim 34, wherein the wire drive includes an element adapted to engage with the suture wire to resist proximal movement of the suture wire.

40. The instrument of claim 39, wherein the element is adapted to engage with the suture wire to resist proximal movement of the suture wire when a portion of the wire drive moves proximally so as to re-engage the suture wire at a proximal position.

41. The instrument of claim 40, wherein the element is adapted to disengage from the suture wire when the portion of the wire drive re-engages with the suture wire to move the suture wire distally.

42. The instrument of claim 34, wherein the cutter includes a drive tube that extends along a portion of the shaft, and wherein the wire drive is at least partially located within the drive tube.

43. The instrument of claim 39, wherein the element is biased toward engagement with the suture wire during movement in the second direction.

44. The instrument of claim 34, wherein the second channel and the opening are arranged so that the suture wire extends in a generally distal direction upon exiting the opening.

45. The instrument of claim 34, wherein when the wire drives moves the suture wire in the second channel, a free end of the suture wire moves from the opening and follows a curved path so that the free end moves back toward the instrument.

46. The instrument of claim 34, wherein the wire drive is adapted to move the suture wire from the opening with force sufficient so that a free end of the suture wire can penetrate tissue.

47. The instrument of claim 34, adapted to form an approximately circular wire loop suture by suture wire that is driven out of the opening in the distal end.

48. The instrument of claim 47, adapted to form the wire loop suture at an extreme axial end of the shaft.

49. The instrument of claim 34, wherein the cutter is adapted to cut the suture wire so as to form a sharp point on the suture wire.

50. The instrument of claim 49, wherein the cutter is adapted to cut the suture wire to free a length of the suture wire from the instrument after at least a portion of the length of suture wire is passed through the second channel.

51. The instrument of claim 34, wherein the cutter is adapted to cooperate with a portion of the second channel to cut the suture wire.

52. The instrument of claim 34, wherein the cutter includes a cutting surface adapted to move distally along the shaft to cut the suture wire.

53. The instrument of claim 34, wherein the cutter includes a cutting bar adapted to move distally to cut the suture wire.

54. The instrument of claim 34, wherein the cutter is adapted to cut the suture wire so that a formed wire loop suture is freed from suture wire remaining attached to the instrument.

55. The instrument of claim 34, wherein the wire drive is adapted to move the suture wire in an axial direction within the shaft.

56. The instrument of claim 34, wherein the second channel includes an “

S”

shaped portion with a convex portion and a concave portion.

57. The instrument of claim 56, wherein the cutter is adapted to cut the suture wire at a location between the convex portion and the concave portion.

58. The instrument of claim 34, further comprising:

a continuous length of suture wire, wherein the instrument is adapted to form a plurality of wire loop sutures from the continuous length of suture wire.

59. The instrument of claim 34, adapted for use in a minimally invasive surgical procedure.

60. The instrument of claim 34, wherein the distal end includes an angled end face.

61. The instrument of claim 60, arranged to form a wire loop suture in tissue by positioning the angled end face adjacent the tissue and driving the suture wire through the second channel such that a free end of the suture wire penetrates the tissue and follows a loop-like trajectory.

62. The instrument of claim 34, further comprising:

a recessed portion at the distal end, the recessed portion adapted to receive tissue or material to be sutured.

63. The instrument of claim 62, wherein the recessed portion includes a curved slot adapted to closely fit a portion of the suture wire that forms the wire loop suture.

64. The instrument of claim 63, wherein the curved slot includes a scalloped surface adapted to guide a free end of suture wire into the curved slot.

65. The instrument of claim 62, wherein the recessed portion includes a central slot and a pair of side recesses on opposite lateral sides of the central slot, and wherein the central slot is adapted to receive suture wire that is driven out of the opening to form the wire loop suture, and the pair of side recesses are adapted to receive portions of a pliable surface against which the distal end is placed.

66. The instrument of claim 34, adapted to form, with the suture wire moved out of the opening, the wire loop suture in a spiral shape having a leading end that is adjacent to a trailing portion of the suture wire.

67. The instrument of claim 34, wherein the cutter is adapted to cut the trailing end of suture wire that forms the wire loop suture and to bend a portion of the trailing end inwardly toward a center of the loop.

68. The instrument of claim 34, wherein the cam follower of the wire drive is biased toward engagement with the suture wire during movement in the second direction.

69. The instrument of claim 68, wherein the wire drive includes a spring that biases the cam follower toward engagement with the suture wire.

70. A suturing instrument comprising:

a handle;

a lever movably mounted to the handle;

a shaft extending from the handle and having a proximal end and a distal end including an opening;

a first channel adapted to guide a suture wire in movement toward the opening;

a second channel extending from the first channel and shaped to impart a curvature to the suture wire as the suture wire moves in the second channel;

a cutter adapted to cut the suture wire; and

a wire drive adapted to move the suture wire in the second channel;

wherein suture wire, when moved out of the opening, forms a wire loop suture, wherein movement of the lever in a first direction actuates the wire drive to move the suture wire in the second channel, and wherein the lever is linked to the wire drive so that the lever is also movable in the first direction without actuating the wire drive to move the suture wire.

71. The instrument of claim 70, wherein movement of the lever in a first range of motion in the first direction actuates the wire drive to move the suture wire, and movement of the lever in a second range of motion in the first direction does not actuate the wire drive to move the suture wire.

72. The instrument of claim 71, wherein movement of the lever in the second range of motion in the first direction actuates the cutter to cut the suture wire.

73. The instrument of claim 70, wherein the lever is linked to the wire drive by a compliant member.

74. The instrument of claim 73, wherein the compliant member includes a spring.

75. The instrument of claim 74, wherein the handle includes a stop that when contacted by a portion of the wire drive prevents further actuation of the wire drive.

76. The instrument of claim 70, wherein the wire drive is adapted to engage with a side of the suture wire to move the suture wire in the second channel.

77. The instrument of claim 70, wherein the cutter includes a drive tube that extends along a portion of the shaft, and wherein the wire drive is at least partially located within the drive tube.

78. The instrument of claim 70, wherein the second channel and the opening are arranged so that the suture wire extends in a generally distal direction upon exiting the opening.

79. The instrument of claim 70, wherein when the wire drive moves the suture wire in the second channel, a free end of the suture wire moves from the opening and follows a curved path so that the free end moves back toward the instrument.

80. The instrument of claim 70, wherein the wire drive is adapted to move the suture wire from the opening with force sufficient so that a free end of the suture wire can penetrate tissue.

81. The instrument of claim 70, adapted to form an approximately circular wire loop suture by suture wire that is driven out of the opening in the distal end.

82. The instrument of claim 81, adapted to form the wire loop suture at an extreme axial end of the shaft.

83. The instrument of claim 70, wherein the cutter is adapted to cut the suture wire so as to form a sharp point on the suture wire.

84. The instrument of claim 70, wherein the cutter is adapted to cut the suture wire to free a length of the suture wire from the instrument after the length of suture wire is passed through the second channel.

85. The instrument of claim 70, wherein the cutter is adapted to cooperate with a portion of the second channel to cut the suture wire.

86. The instrument of claim 70, wherein the cutter includes a cutting surface adapted to move distally along the shaft to cut the suture wire.

87. The instrument of claim 70, wherein the cutter includes a cutting bar adapted to move distally to cut the suture wire.

88. The instrument of claim 70, wherein the cutter is adapted to cut the suture wire so that a formed wire loop suture is freed from suture wire remaining attached to the instrument.

89. The instrument of claim 70, wherein the wire drive is adapted to move the suture wire in an axial direction within the shaft.

90. The instrument of claim 70, wherein the second channel includes an “

S”

shaped portion with a convex portion and a concave portion.

91. The instrument of claim 90, wherein the cutter is adapted to cut the suture wire at a location between the convex portion and the concave portion.

92. The instrument of claim 70, further comprising:

a continuous length of suture wire, wherein the instrument is adapted to form a plurality of wire loop sutures from the continuous length of suture wire.

93. The instrument of claim 70, adapted for use in a minimally invasive surgical procedure.

94. The instrument of claim 70, wherein the distal end includes an angled end face.

95. The instrument of claim 94, wherein the instrument is arranged to form a wire loop suture in tissue by positioning the angled end face adjacent the tissue and driving the suture wire through the second channel such that a free end of the suture wire penetrates the tissue and follows a loop-like trajectory.

96. The instrument of claim 70, further comprising:

a recessed portion at the distal end, the recessed portion adapted to receive tissue or material to be sutured.

97. The instrument of claim 96, wherein the recessed portion includes a curved slot adapted to closely fit the portion of the suture wire when received in the curved slot.

98. The instrument of claim 97, wherein the curved slot includes a scalloped surface adapted to guide a free end of suture wire into the curved slot.

99. The instrument of claim 96, wherein the recessed portion includes a central slot and a pair of side recesses on opposite lateral sides of the central slot, and wherein the central slot is adapted to receive suture wire that is driven out of the opening to form the wire loop suture, and the pair of side recesses are adapted to receive portions of a pliable surface against which the distal end is placed.

100. The instrument of claim 70, adapted to form, with the suture wire moved out of the opening, the wire loop suture in a spiral shape having a leading end that is adjacent to a trailing portion of the suture wire.

101. The instrument of claim 70, wherein the cutter is adapted to both cut the trailing end of suture wire forming the wire loop suture and bend a portion of the trailing end inwardly toward a center of the wire loop suture.

102. A suturing instrument comprising:

a handle;

a lever movably mounted to the handle;

a shaft extending from the handle and having a proximal end and a distal end including an opening;

a first channel adapted to guide a suture wire in movement toward the opening;

a second channel extending from the first channel and shaped to impart a curvature to the suture wire as the suture wire moves in the second channel;

a cutter adapted to cut the suture wire; and

a wire drive adapted to move the suture wire in the second channel;

wherein suture wire moved out of the opening forms a wire loop suture, and wherein movement of the lever through a range of motion in a first direction actuates the wire drive to move the suture wire in the second channel and actuates the cutter to cut the suture wire such that one complete wire loop suture is formed and cut from suture wire remaining attached to the instrument.

103. The instrument of claim 102, wherein movement of the lever in the first direction within a first portion of the range of motion actuates the wire drive to move the suture wire, and movement of the lever in the first direction within a second portion of the range of motion does not actuate the wire drive to move the suture wire.

104. The instrument of claim 103, wherein movement of the lever in the second portion of the range of motion actuates the cutter to cut the suture wire.

105. The instrument of claim 102, wherein the lever is linked to the wire drive by a compliant member.

106. The instrument of claim 105, wherein the compliant member includes a spring.

107. The instrument of claim 106, wherein the handle includes a stop that when contacted by a portion of the wire drive prevents further actuation of the wire drive.

108. The instrument of claim 102, wherein the wire drive is adapted to engage with a side of the suture wire to move the suture wire in the second channel.

109. The instrument of claim 102, wherein the cutter includes a drive tube that extends along a portion of the shaft, and wherein the wire drive is partially located within the drive tube.

110. The instrument of claim 102, wherein the second channel and the opening are arranged so that the suture wire extends in a generally distal direction upon exiting the opening.

111. The instrument of claim 102, wherein when the wire drive moves the suture wire in the second channel, a free end of the suture wire moves from the opening and follows a curved path so that the free end moves back toward the instrument.

112. The instrument of claim 102, wherein the wire drive is adapted to move the suture wire from the opening with force sufficient so that a free end of the suture wire can penetrate tissue.

113. The instrument of claim 102, adapted to form an approximately circular wire loop suture by suture wire that is driven out of the opening in the distal end.

114. The instrument of claim 113, adapted to form the wire loop suture at an extreme axial end of the shaft.

115. The instrument of claim 102, wherein the cutter is adapted to cut the suture wire so as to form a sharp point on the suture wire.

116. The instrument of claim 102, wherein the cutter is adapted to cut the suture wire to free a length of suture wire from the instrument after the length of suture wire is passed through the second channel.

117. The instrument of claim 102, wherein the cutter is adapted to cooperate with a portion of the second channel to cut the suture wire.

118. The instrument of claim 102, wherein the cutter includes a cutting surface adapted to move distally along shaft to cut the suture wire.

119. The instrument of claim 102, wherein the cutter includes a cutting bar adapted to move distally to cut the suture wire.

120. The instrument of claim 102, wherein the cutter is adapted to cut the suture wire so that the formed wire loop suture is freed from suture wire remaining attached to the instrument.

121. The instrument of claim 102, wherein the wire drive is adapted to move the suture wire in an axial direction within shaft.

122. The instrument of claim 102, wherein the second channel includes an “

S”

shaped portion with a convex portion and a concave portion.

123. The instrument of claim 122, wherein the cutter is adapted to cut the suture wire at a location between the convex portion and the concave portion.

124. The instrument of claim 102, further comprising:

a continuous length of suture wire, wherein the instrument is adapted to form a plurality of wire loops sutures from the continuous length of suture wire.

125. The instrument of claim 102, adapted for use in a minimally invasive surgical procedure.

126. The instrument of claim 102, wherein the distal end includes an angled end face.

127. The instrument of claim 126, arranged to form the wire loop suture in tissue by positioning the angled end face adjacent the tissue and driving the suture wire through the second channel such that a free end of the suture wire penetrates the tissue and follows a loop-like trajectory.

128. The instrument of claim 102, further comprising:

a recessed portion at the distal end, the recessed portion adapted to receive tissue or material to be sutured.

129. The instrument of claim 128, wherein the recessed portion includes a curved slot adapted to closely fit the portion of the suture wire when received in the curved slot.

130. The instrument of claim 129, wherein the curved slot includes a scalloped surface adapted to guide a free end of suture wire into the curved slot.

131. The instrument of claim 128, wherein the recessed portion includes a central slot and a pair of side recesses on opposite lateral sides of the central slot, and wherein the central slot is adapted to receive suture wire that is driven out of the opening, and the pair of side recesses are adapted to receive portions of a pliable surface against which the distal end is placed.

132. The instrument of claim 102, adapted to form the wire loop suture in a spiral shape having a leading end that is adjacent to a trailing portion of the suture wire.

133. The instrument of claim 102, wherein the cutter is adapted to both cut the trailing end of suture wire forming the wire loop suture and bend a portion of the trailing end inwardly toward a center of the wire loop suture.