System for wound closure

• US 6,641,592 B1
• Filed: 11/15/2000
• Issued: 11/04/2003
• Est. Priority Date: 11/19/1999
• Status: Expired due to Term

• Current Assignee: Cardiva Medical, Inc. (Haemonetics Corporation)
• Original Assignee: LSI Solutions, Inc.
• Inventors: Sauer, Jude S., Hammond, John F.
• Primary Examiner(s): VANATTA, AMY B
• Application Number:
  US09/713,558
• Time in Patent Office: 1,084 Days
• Field of Search: 606/139, 606/144, 606/145, 606/147, 606/148, 606/149, 606/222, 606/223, 606/232
• US Class Current: 606/144
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06004 Means for attaching suture to needle tipping A61B17/06195; connecting wire to other metallic objects B21F15/00
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• 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 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end

Abstract

A system is provided for closure of a wound in a patient, such as a puncture hole in a blood vessel, with a suture having a first apparatus for applying a suture capable of closing the wound and a second apparatus for securing a sleeve member over the suture to secure the wound closed. The first apparatus includes a housing, a shaft having first and second ends in which the first end is coupled to the housing, a tissue engaging section coupled to the second end of the shaft, and first and second needles which extend from the housing through the shaft into the tissue engaging section. The tissue engaging section is directed through the wound, and has first and second gaps in which each gap has opposing surfaces into which different sides of the wound can be received. The first needle is extendable into a holder through the first gap to capture one of the two ends of a suture material or thread, and is retractable with the captured suture. The second needle is extendable into another holder through the second gap to capture the opposite end of the suture material, and is retractable with the captured suture. A selecting mechanism enables the selection of the first or second needles. The user operates an actuator member to drive and retract each of the selected needles to retrieve each end of the suture material through the tissue about the wound. After removal of the first apparatus, the suture material is left across the wound, and the second apparatus secures a sleeve member over the two ends of the suture material in proximity of the wound to maintain the wound closed and then cuts the suture material exiting the sleeve member.

Claims

1. A tissue suturing apparatus comprising:

a tissue engaging section having a distal end and a proximal end, a first tissue receiving gap within the tissue engaging section and a second tissue receiving gap, separate from the first tissue receiving gap, within the tissue engaging section, the first and second tissue receiving gaps facing in different directions from the tissue engaging section.

2. The tissue suturing apparatus of claim 1 wherein the first and second tissue receiving gaps are located on opposite sides of the tissue engaging section.

3. The tissue suturing apparatus of claim 2 wherein the first and second tissue receiving gaps are located on opposite perimetrical sides of the tissue engaging section.

4. The tissue suturing apparatus of claim 1 further comprising a shaft connected to a handle, the shaft attached to the proximal end of the tissue engaging section, and a guide tube attached to the distal end of the tissue engaging section.

5. The tissue suturing apparatus of claim 1 wherein the distal end of the tissue engaging section is offset angularly from the proximal end of the tissue engaging section.

6. The tissue suturing apparatus of claim 1 wherein the first and second tissue receiving gaps are displaced from each other longitudinally along the tissue engaging section.

7. The tissue suturing apparatus of claim 6 wherein the first tissue receiving gap is closer to the proximal end of the tissue engaging section than the second tissue receiving gap.

8. The tissue suturing apparatus of claim 1 wherein the first tissue receiving gap comprises a first stop surface located on a distal face of the first tissue receiving gap and the second tissue receiving gap comprises a second stop surface located on a proximal face of the second tissue receiving gap.

9. The tissue suturing apparatus of claim 8 wherein the first stop surface is angled less than 15 degrees from a perpendicular cross-section of the tissue engaging section adjacent the distal end and wherein the second stop surface is angled less than 15 degrees from a perpendicular cross-section of the tissue engaging section adjacent the proximal end.

10. The tissue suturing apparatus of claim 1 wherein a proximal face of the first tissue receiving gap and a proximal face of the second tissue receiving gap each comprise an opening leading to a channel for a needle.

11. The tissue suturing apparatus of claim 10 wherein the opening on the proximal face of the first tissue receiving gap is closer to the proximal end of the tissue engaging section than the opening on the proximal face of the second tissue receiving gap.

12. The tissue suturing apparatus of claim 1 wherein a distal face of the first tissue receiving gap and a distal face of the second tissue receiving gap each comprise an opening leading to a suture holder.

13. The tissue suturing apparatus of claim 12 wherein the suture holder is also a ferrule holder.

14. The tissue suturing apparatus of claim 13 further comprising an additional channel for holding suture material adjacent each ferrule holder.

15. The tissue suturing apparatus of claim 1 further comprising a first needle channel, a second needle channel, and a channel for suture material within the proximal end of the tissue engaging section.

16. The tissue suturing apparatus of claim 1 wherein the tissue engaging section has a substantially oval-shaped cross-section.

17. The tissue suturing apparatus of claim 1 wherein the first tissue receiving gap extends a depth greater than half a width of the tissue engaging section and wherein the second tissue receiving gap extends a depth greater than half the width of the tissue engaging section.

18. The tissue suturing apparatus of claim 1 wherein a cross section taken at the first tissue receiving gap also includes a needle channel for holding a needle adapted to pass through the second tissue receiving gap.

19. The tissue suturing apparatus of claim 1 wherein a cross section taken at the second tissue receiving gap also includes a ferrule holder for holding a ferrule adapted to be captured by a needle passing through the first tissue receiving gap.

20. A tissue suturing apparatus comprising:

a tissue engaging section having a distal end and a proximal end, a first tissue receiving gap within the tissue engaging section and a second tissue receiving gap, separate from the first tissue receiving gap, within the tissue engaging section, wherein the first and second tissue receiving gaps are displaced from each other longitudinally along the tissue engaging section.

21. The tissue suturing apparatus of claim 20 wherein the first and second tissue receiving gaps are facing in different directions from the tissue engaging section.

22. The tissue suturing apparatus of claim 20 wherein the distal end of the tissue engaging section is offset angularly from the proximal end of the tissue engaging section.

23. The tissue suturing apparatus of claim 20 wherein the first tissue receiving gap is closer to the proximal end of the tissue engaging section than the second tissue receiving gap.

24. The tissue suturing apparatus of claim 20 wherein a proximal face of the first tissue receiving gap and a proximal face of the second tissue receiving gap each comprise an opening leading to a channel for a needle.

25. The tissue suturing apparatus of claim 24 wherein the opening on the proximal face of the first tissue receiving gap is closer to the proximal end of the tissue engaging section than the opening on the proximal face of the second tissue receiving gap.

26. The tissue suturing apparatus of claim 24 wherein a distal face of the first tissue receiving gap and a distal face of the second tissue receiving gap each comprise an opening leading to a suture holder.

27. The tissue suturing apparatus of claim 26 wherein the suture holder is also a ferrule holder.

28. The tissue suturing apparatus of claim 27 further comprising an additional channel for holding suture material adjacent each ferrule holder.

29. The tissue suturing apparatus of claim 20 further comprising a first needle channel, a second needle channel, and a channel for suture material within the proximal end of the tissue engaging section.

30. The tissue suturing apparatus of claim 20 wherein the first tissue receiving gap extends a depth greater than half a width of the tissue engaging section and wherein the second tissue receiving gap extends a depth greater than half the width of the tissue engaging section.

31. The tissue suturing apparatus of claim 20 wherein a cross section taken at the first tissue receiving gap also includes a needle channel for holding a needle adapted to pass through the second tissue receiving gap.

32. The tissue suturing apparatus of claim 20 wherein a cross section taken at the second tissue receiving gap also includes a ferrule holder for holding a ferrule adapted to be captured by a needle passing through the first tissue receiving gap.

33. The tissue suturing apparatus of claim 20 wherein the first and second tissue receiving gaps are located on opposite perimetrical sides of the tissue engaging section.

34. The tissue suturing apparatus of claim 24 further comprising a needle within the channel for a needle, the needle including:

a shaft having a diameter;

a tip including a point tapering to a distal end of the needle; and

,

a groove between the shaft and the tip.

35. The tissue suturing apparatus of claim 34 wherein a diameter at a proximal end of the point defines a maximum diameter of the tip, a region of the tip tapering proximally towards the shaft, wherein the region has a proximal end diameter less than the diameter of the shaft.

36. The tissue suturing apparatus of claim 35 further comprising a section between the shaft and the tip, the section tapering distally from the diameter of the shaft to the proximal end diameter of the region of the tip, the section and the region defining the groove.

37. The tissue suturing apparatus of claim 34 wherein the shaft has a substantially circular cross-section.

38. The tissue suturing apparatus of claim 34 wherein the shaft of the needle is a length adapted for receipt in the channel of the tissue suturing apparatus.

39. The tissue suturing apparatus of claim 34 wherein the shaft of the needle has a distal end adjacent the tip and a proximal end having a spherical member for receipt within a handle member of the tissue suturing apparatus.

40. The tissue suturing apparatus of claim 34 wherein the point of the needle is conically shaped.

41. A tissue suturing apparatus comprising:

a tissue engaging section having a distal end and a proximal end, a first ferrule holder and a second ferrule holder, wherein the first ferrule holder is closer to the proximal end of the tissue engaging section than the second ferrule holder.

42. The tissue suturing apparatus of claim 41 wherein the distal end of the tissue engaging section is angularly offset from the proximal end of the tissue engaging section, and wherein the first ferrule holder and the second ferrule holder are parallel to a longitudinal axis extending through the distal end of the tissue engaging section.

43. The tissue suturing apparatus of claim 41 wherein the first ferrule holder and the second ferrule holder each include an adjacent channel for holding suture material.

44. The tissue suturing apparatus of claim 41 wherein the first ferrule holder includes a first opening for accepting a first ferrule and the second ferrule holder includes a second opening for accepting a second ferrule, wherein the first opening lies in a plane substantially perpendicular to a longitudinal axis extending through the distal end of the tissue engaging section, and wherein the second opening lies in a plane askew to the longitudinal axis extending through the distal end of the tissue engaging section.

45. A tissue suturing apparatus comprising:

a suture tube having a single common passageway; and

,

a splitter attached to the suture tube, the splitter having a connector tube open to and sharing the common passageway, the connector tube attached to the suture tube the splitter further having a first tube and a second tube extending from the connector tube, each of the first tube and the second tube having an end open to the common passageway in the connector tube.

46. The tissue suturing apparatus of claim 45 wherein the splitter comprises a Y-shaped extension member.

47. The tissue suturing apparatus of claim 45 further comprising a loop of suture material exiting the suture tube, wherein the loop of suture material is divided into a first loop exiting the first tube and a second loop exiting the second tube, wherein movement of either side of the loop of suture material in the suture tube is detectable by viewing movement of the first loop and second loop.

48. A tissue suturing apparatus comprising:

a suture tube;

a splitter attached to the suture tube, the splitter having a connector tube attached to the suture tube and having a first tube and a second tube each in communication with the connector tube; and

,

a first hollow transparent member attached to the first tube and a second hollow transparent member attached to the second tube.

49. The tissue suturing apparatus of claim 48 wherein a connecting portion of the first and second hollow transparent members for connecting the first and second hollow transparent members to the first and second tubes, respectively, has a first width, and wherein the first and second hollow transparent members flare outwardly from each connecting portion to a second width greater than the first width.

50. A tissue suturing apparatus comprising:

a suture tube; and

,

a splitter attached to the suture tube, the splitter having a connector tube attached to the suture tube and having a first tube and a second tube each in communication with the connector tube; and

,

a handle member, wherein the suture tube extends through the handle member and exits an opening in the handle member, the first and second tubes of the splitter positioned exteriorly of the handle member.

51. A kit for suturing a wound, the kit comprising:

a tissue suturing apparatus including a first needle, a first ferrule for holding a first end of suture material, a second needle, and a second ferrule for holding a second end of suture material; and

,

a suture securing instrument including a sleeve member compartment, a rod having a hammer shaped section for crimping a sleeve member, and a knife for cutting suture material.

52. The kit of claim 51 further comprising a sheath for accepting either the tissue suturing apparatus or the suture securing instrument.

53. The kit of claim 52 further comprising a guide wire.

54. The kit of claim 51 further comprising a dilator assembly.

55. The kit of claim 51 further comprising an attachment for placement over a distal end of the suture securing instrument, the attachment having a funnel shaped opening for guiding suture material into the sleeve member compartment.

56. The kit of claim 51 wherein the tissue suturing apparatus further comprises a suture tube for holding suture material and a Y-shaped tubular extension member attached to a proximal end of the suture tube.

57. A method of approximating tissue sections, the method comprising:

inserting a tissue suturing apparatus through the wound;

positioning a tissue engaging section of the tissue suturing apparatus adjacent the wound;

receiving a first edge of the wound within a first gap of the tissue engaging section;

driving a first needle through the first gap and the first edge of the wound;

capturing a first ferrule with the first needle, the first ferrule having an attached strand of suture material;

drawing the first needle and captured ferrule back through the first gap and the first edge of the wound;

receiving a second edge of the wound within a second gap, located on a longitudinally displaced portion of the tissue engaging section, of the tissue suturing apparatus;

driving a second needle through the second gap and the second edge of the wound;

capturing a second ferrule with the second needle, the second ferrule having an attached strand of suture material; and

, drawing the second needle and captured ferrule back through the second gap and the second edge of the wound.

58. The method of claim 57 further comprising pulling an actuator member to drive the first needle and the second needle.

59. The method of claim 57 further comprising selecting the second needle with a needle selection mechanism.

60. The method of claim 57 wherein receiving a second edge of the wound within a second gap comprises lifting up the tissue suturing apparatus and pushing forward the tissue suturing apparatus.

61. The method of claim 57 wherein the suture material passes through a suture tube, the method further comprising attaching a splitter to the suture tube, the splitter having a first tube and a second tube each in communication with a connector tube, the method further comprising viewing movement of the suture material adjacent the first tube as the first ferrule is drawn through the first gap and the first edge of the wound, and viewing movement of the suture material adjacent the second tube as the second ferrule is drawn through the second gap and the second edge of the wound.

62. The method of claim 57 further comprising removing the tissue suturing apparatus from the wound.

63. The method of claim 62 further comprising angularly rotating the tissue suturing apparatus to remove the tissue engaging section, which has a distal end angled from a proximal end, from the wound.

64. The method of claim 62 further comprising cutting the suture material and freeing the tissue suturing apparatus.

65. The method of claim 64 further comprising threading the suture material into a sleeve member loaded into a suture securing instrument.

66. The method of claim 65 wherein threading the suture material into a sleeve member comprises placing an attachment over a distal end of the suture securing instrument, threading the suture material through an opening of the attachment, and removing the attachment.

67. The method of claim 65 further comprising positioning a distal end of the suture securing instrument adjacent the wound, crimping the sleeve member, and cutting the suture material.

68. The method of claim 67 wherein crimping the sleeve member comprises drawing a hammer shaped section of a rod within the suture securing instrument in a proximal direction.

69. The method of claim 68 wherein cutting the suture material comprises drawing the hammer shaped section of the rod in a proximal direction, abutting a pivotal knife with the hammer shaped section, and pivoting the knife past suture material exiting a proximal end of the sleeve member.

70. The method of claim 57 wherein inserting a tissue suturing apparatus through the wound comprises placing the apparatus at an angle approximately 30 to 45 degrees relative to the wound.

71. The method of claim 57 wherein receiving a first edge of the wound within a first gap of the tissue suturing apparatus comprises inserting the tissue engaging section within the wound, angling the tissue suturing apparatus towards the first gap, and pulling the tissue suturing apparatus in a proximal direction until a stop surface along a distal side of the first gap abuts against the first edge of the wound.

72. The method of claim 71 wherein receiving a second edge of the wound within a second gap of the tissue suturing apparatus comprises angling the tissue suturing apparatus towards the second gap and pushing the tissue suturing apparatus in a distal direction until a stop surface along a proximal side of the second gap abuts against a second edge of the wound.

73. The method of claim 57 wherein the tissue suturing apparatus includes a longitudinal axis and wherein receiving a first edge of the wound within a first gap and a second edge of the wound within a second gap includes limiting rotation of the tissue suturing apparatus about its longitudinal axis.

74. A tissue suturing apparatus comprising:

a shaft;

a first needle having a proximal end and a pointed distal end;

a second needle having a proximal end and a pointed distal end;

an actuator for driving either the first needle or the second needle through the shaft; and

,

a needle selection mechanism positioned adjacent the proximal end of the first needle and the proximal end of the second needle, the needle selection mechanism arranged for selecting which needle will be driven by the actuator through the shaft.

75. The tissue suturing apparatus of claim 74 wherein the needle selection mechanism includes a movable selector lever.

76. The tissue suturing apparatus of claim 75 wherein the needle selection mechanism includes a cam member through which the first needle and the second needle extend, the cam member rotatable upon movement of the selector lever.

77. The tissue suturing apparatus of claim 76 further comprising a retainer member, wherein a proximal end of the first needle or second needle is capturable within the retainer member.

78. The tissue suturing apparatus of claim 77 wherein movement of the selector lever in one direction positions the proximal end of the first needle in the retainer member, and movement of the selector lever in an opposite direction positions the proximal end of the second needle in the retainer member.

79. The tissue suturing apparatus of claim 78 wherein the actuator includes notches for receiving whichever needle is not retained within the retainer member, the needle held within a notch of the actuator being drivable through the shaft of the tissue suturing apparatus.

80. The tissue suturing apparatus of claim 74 wherein the proximal end of the first needle includes a spherical member and the proximal end of the second needle includes a spherical member.

81. The tissue suturing apparatus of claim 74 wherein the actuator includes a pair of notches, wherein the needle selection mechanism forces one of the first needle or the second needle into one of the notches, the needle within a notch being drivable through the shaft upon movement of the actuator.

82. The tissue suturing apparatus of claim 81 wherein the spherical member abuts a proximal side of the notch for maintaining movement of the needle with the actuator.

83. A suture securing instrument comprising:

a handle member;

a hollow tube attached at its proximal end to the handle member, a distal end of the hollow tube having a tip opening allowing access to a securing sleeve member compartment and an upper wall opening allowing passage of suture material;

a knife pivotally held within the distal end of the hollow tube; and

, a rod movable through the hollow tube by actuation of the handle member, the rod having a contoured distal end including a hammer shaped section;

wherein proximal movement of hammer shaped section of the rod within the hollow tube first moves the hammer shaped section past the securing sleeve member compartment and then abuts the hammer shaped section with a lower surface of the knife, pivoting an upper cutting surface of the knife towards the upper wall opening.

84. The suture securing instrument of claim 83 further comprising a securing sleeve member within the securing sleeve member compartment, wherein the securing sleeve member is crimped upon proximal movement of the hammer shaped section of the rod past the securing sleeve member compartment.

85. The suture securing instrument of claim 84 further comprising suture material threaded through the tip opening, the securing sleeve member, and out the upper wall opening, wherein the suture material is cut by the knife upon proximal movement of the hammer shaped section of the rod past the lower surface of the knife.

86. The suture securing instrument of claim 83 wherein the contoured distal end of the rod includes a step proximal to the hammer shaped section, a back portion of the knife lying upon the step to prevent the knife from pivoting towards the upper wall opening prior to proximal movement of the rod.

87. The suture securing instrument of claim 83 further comprising an attachment securable to the distal end of the hollow tube, the attachment comprising a funnel shaped opening for assisting in threading suture material into the securing sleeve member compartment.

88. The suture securing instrument of claim 83 further comprising a pin passing through opposite sides of the distal end of the hollow tube, the pin arranged for pivotally supporting the knife within the distal end of the hollow tube.

89. The suture securing instrument of claim 88 wherein the knife includes a U-shaped opening through which the pin passes.

90. A system for closure of a wound in a patient with a suture material having two ends comprising:

a first apparatus comprising a housing, a shaft having a first end and a second end in which said first end is coupled to the housing, a tissue engaging section coupled to said second end of said shaft, and a first needle and a second needle in which said first and second needles extend from the housing through the shaft into said tissue engaging section;

said tissue engaging section having a first opening and a second opening for said first and second needles, respectively, a first needle receiving portion and second needle receiving portion for said first and second needles, respectively, capable of retaining one of the ends of the suture material, and a first gap having two opposing surfaces into which one side of said wound is received in which said first opening extends through one of said opposing surfaces of said first gap and said first needle receiving portion is provided through the other of said opposing surfaces of said first gap facing said first opening, and a second gap having two opposing surfaces into which the another side of said wound is received in which said second opening extends through one of said opposing surfaces of said second gap and said second needle receiving portion is provided through the other of said opposing surfaces of said second gap facing said second opening;

means for selecting one of said first and second needles;

means in said housing for driving said selected one of said needles in which when said first needle is selected, said first needle is extendable into said first gap through said first opening to capture said first needle receiving portion and retractable into said tissue engaging section to locate a first location in said tissue through which said first end of said suture thread extends, and when said second needle is selected, said second needle is extendable into said second gap through said second opening to capture said second needle receiving portion and retractable into said tissue engaging section to locate a second location in said tissue through which said second end of said suture material extends; and

a second apparatus having means for securing a sleeve member over the two ends of the suture material to maintain said wound closed at said first and second locations in said tissue.