Suture Device

• US 20100145364A1
• Filed: 01/20/2005
• Published: 06/10/2010
• Est. Priority Date: 05/21/2004
• Status: Active Grant

• Current Assignee: NeatStitch Ltd.
• Original Assignee: NeatStitch Ltd.
• Inventors: Lore, Rami, Keren, Dvir
• Granted Patent: US 8,034,060 B2
• Time in Patent Office: Days
• 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 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments

Abstract

A suture insertion device (120) includes a shaft (124), which is adapted to be inserted into a body cavity (154). First and second needles (160) hold respective first and second ends of a suture thread (122). First and second needle guides (130) are attached to the shaft and respectively hold the first and second needles. The needle guides have a first operative configuration in which the needle guides are held parallel to the axis of the shaft for insertion of the shaft into the body cavity and a second operative configuration in which the needle guides are deployed outward from the shaft within the body cavity so as to point the needles in a proximal direction. An ejector (164) is operative to eject the needles from the needle guides in the second operative configuration so as to cause the needles to penetrate tissue (156) adjoining the body cavity.

Claims

1. A suture insertion device, comprising:

a shaft, having a longitudinal axis and a distal end, which is adapted to be inserted into a body cavity;

first and second needles, which are configured to hold respective first and second ends of a suture thread;

first and second needle guides, which are attached to the shaft and respectively hold the first and second needles, the needle guides having a first operative configuration in which the needle guides are held parallel to the axis for insertion of the shaft into the body cavity and a second operative configuration in which the needle guides are deployed outward from the shaft within the body cavity so as to point the needles in a proximal direction; and

an ejector, which is operative to eject the needles from the needle guides in the second operative configuration so as to cause the needles to penetrate tissue adjoining the body cavity.

2. The device according to claim 1, wherein the needles have respective points, and wherein the needle guides contain the needles so that the points do not contact the tissue while the needles are held by the needle guides.

3. The device according to claim 2, wherein the needle guides have respective outer ends, and are deployed outward from the shaft in the second operative configuration so as to permit an operator of the device to bring the outer ends of the needle guides into engagement with the tissue before ejecting the needles.

4. The device according to claim 1, wherein in the second operative configuration, the needle guides curve out of the shaft so as to point in the proximal direction.

5. The device according to claim 4, wherein in the second operative configuration, the needle guides are deployed from the distal end of the shaft and curve back in the proximal direction.

6. The device according to claim 4, wherein the needle guides comprise a superelastic material, which is formed prior to assembly of the device so as to have a curved shape.

7. The device according to claim 6, wherein the needle guides comprise superelastic tubes having lumens that contain the needles.

8. The device according to claim 6, wherein the needle guides comprise plates of the superelastic material, and wherein the needles are held against the plates until the needles are ejected.

9. The device according to claim 8, wherein the needle guides comprise covers for holding the needles against the plates, and wherein the covers are attached to the plates so as to shift longitudinally along the plates when the needle guides are deployed from the first operative configuration to the second operative configuration.

10. The device according to claim 4, wherein the needles comprise an elastic material, which is formed so that the needles assume a straight shape upon being ejected from the needle guides.

11. The device according to claim 4, and comprising one or more stabilizers, which are contained within the shaft while the needle guides are in the first operative configuration, and which are coupled to be deployed together with the needle guides so as to stabilize the needle guides in the second operative configuration.

12. The device according to claim 11, wherein the needle guides have outer ends from which the needles are ejected, and wherein the stabilizers comprise cords, which couple the outer ends of the needle guides to the shaft.

13. The device according to claim 12, wherein the stabilizers comprise wings, which extend outward from the distal end of the shaft in a direction transverse to a plane defined by the needle guides, and wherein the cords couple the needle guides to the wings.

14. The device according to claim 12, wherein the stabilizers comprise couplers, which are attached to the outer ends of the needle guides so as to fix the cords to the needle guides.

15. The device according to claim 11, wherein the stabilizers comprise struts, which open outward from the shaft in order to hold the needle guides.

16. The device according to claim 1, wherein the first and second needle guides are non-symmetrical in the second operative configuration.

17. The device according to claim 16, wherein the needle guides have respective outer ends, and are formed so that in the second operative configuration, the outer ends of the first and second needle guides may be brought into simultaneous engagement with the tissue while the shaft is angled obliquely relative to the tissue.

18. The device according to claim 1, wherein the suture thread held by the first and second needles is a first thread, and comprising third and fourth needle guides and third and fourth needles, which are respectively held by the third and fourth needle guides and are configured to hold a second suture thread, wherein the ejector is operative to eject the first, second, third and fourth needles, thereby passing the ends of both the first and second suture threads through the tissue.

19. The device according to claim 18, wherein the first, second, third and fourth needles and the first and second suture threads are configured so as to produce two parallel stitches through the tissue.

20. The device according to claim 18, wherein the first, second, third and fourth needles and the first and second suture threads are configured so as to produce two crossed stitches through the tissue.

21. The device according to claim 1, wherein the needles are formed from a plate of a flat material.

22. The device according to claim 21, wherein each of the needles comprises an eye, and wherein each of the first and second ends of the suture thread is respectively inserted through and fastened within the eye of one of the first and second needles.

23. The device according to claim 1, wherein each of the needles comprises a tube.

24. The device according to claim 23, wherein each of the first and second ends of the suture thread is respectively inserted into and fastened within the tube of one of the first and second needles.

26. The device according to claim 1, wherein in the second operative configuration, the needle guides are configured to point the needles toward the shaft, so that the needles strike the shaft after passing through the tissue.

27. The device according to claim 26, wherein the shaft comprises a needle trap, for capturing and holding the needles when the needles strike the shaft.

28. The device according to claim 27, wherein the needle trap comprises a cavity in an outer surface of the shaft.

29. The device according to claim 28, wherein the needles comprise a protrusion, which engages the needle trap so as to prevent release of the needles from the needle trap.

30. The device according to claim 27, wherein the needle trap comprises an elastomeric material, which is penetrated by the needles when the needles strike the shaft.

31. The device according to claim 1, wherein the ejector comprises first and second ejector ends and is configured to drive the first and second ejector ends into the first and second needle guides, respectively, in order to eject the needles.

33. The device according to claim 1, and comprising a needle guide holder, which is coupled to advance the needle guides from the first operative configuration to the second operative configuration and is adapted to return the needle guides to the first operative configuration after ejection of the needles.

34. The device according to claim 33, wherein the ejector comprises an actuator, which is coupled to the needle guide holder so as to be operable to eject the needles only when the needle guides are in the second operative configuration.

35. The device according to claim 33, wherein the ejector is coupled to the needle guide holder so that actuation of the ejector by an operator of the device causes the needle guide holder to return the needle guides to the first operative configuration automatically, without further action by the operator.

36. The device according to claim 35, and comprising first and second springs, wherein the needle guide holder is coupled to cock the first spring when the needle guides are advanced to the first operative configuration, and wherein the second spring is coupled to actuate the ejector, such that actuation of the second spring causes the first spring to be released, thereby causing the needle guide holder to return the needle guides to the first operative configuration.

37. The device according to claim 33, and comprising a handle coupled to the shaft, wherein the needle guide holder is contained in the handle.

38. The device according to claim 37, and comprising a release actuator, which is operable to release the shaft from the handle, so as to permit replacement of the shaft.

39. The device according to claim 1, wherein the needle guides are contained inside the shaft in the first operative configuration.

40. The device according to claim 39, wherein the needle guides are adapted to withdraw automatically into the shaft after ejection of the needles.

41. The device according to claim 1, wherein ejection of the needles causes the ends of the suture thread to pass through the tissue, so that upon withdrawal of the device from the body cavity following the ejection of the needles, the suture thread tightens through the tissue while the ends of the suture thread are accessible outside the body cavity.

42. The device according to claim 1, and comprising a cannula, which is adapted to pass from a body surface through a puncture into the body cavity, the cannula having a lumen, wherein the shaft is adapted to pass through the lumen so as to access the body cavity.

43. The device according to claim 42, wherein the cannula has a distal end and comprises a pliable material at the distal end, and wherein after penetrating the tissue, the needles penetrate and are captured in the pliable material.

44. The device according to claim 1, wherein the shaft contains a lumen, which is shaped to receive a guide wire so as to permit the device to be inserted into the body cavity over the guide wire.

45. The device according to claim 1, wherein the shaft contains first and second lumens having respective first and second ports disposed along the shaft at different, respective longitudinal positions, such that flow of a body fluid from the cavity through the first and second lumens is indicative of a depth of insertion of the shaft inside the body cavity.

25. (canceled)

32. (canceled)

46-50. -50. (canceled)

51. A method for suturing tissue adjoining a body cavity in a body of a patient, the method comprising:

providing a shaft having a longitudinal axis and a distal end and having first and second needle guides attached thereto in a first operative configuration in which the needle guides are parallel to the axis, the needle guides holding first and second needles, to which respective first and second ends of a suture thread are attached;

inserting the distal end of the shaft into the body cavity while the needle guides are in the first operative configuration;

deploying the needle guides outward from the distal end of the shaft into the body cavity so that the needle guides assume a second operative configuration in which the needles held by the needle guides point in a proximal direction; and

ejecting the needles from the needle guides in the second operative configuration so as to cause the needles to penetrate the tissue adjoining the body cavity.

52. The method according to claim 51, wherein the needles have respective points, and wherein the needle guides contain the needles so that the points do not contact the tissue while the needles are held by the needle guides.

53. The method according to claim 52, wherein the needle guides have respective outer ends, and comprising bringing the outer ends of the needle guides in the second operative configuration into engagement with the tissue before ejecting the needles.

54. The method according to claim 53, wherein bringing the outer ends of the needle guides into engagement with the tissue comprises pulling the shaft in the proximal direction so as to create tension in the tissue by pressure of the outer ends of the needle guides against the tissue before ejecting the needles.

55. The method according to claim 51, and comprising, after ejecting the needles through the tissue, pulling the shaft together with the needles and the needle guides in the proximal direction so as to remove the shaft, the needles, the needle guides and the ends of the suture thread from the body while the suture thread tightens through the tissue.

56. The method according to claim 55, wherein inserting the distal end of the shaft comprises introducing the distal end of the shaft through a puncture in the tissue, and comprising tying the suture thread after pulling the shaft together with the needles and the needle guides in the proximal direction so as to close the puncture.

57. The method according to claim 56, wherein introducing the distal end comprises inserting the distal end of the shaft through a laparoscopic puncture port, and wherein tying the suture thread comprises closing the laparoscopic puncture port.

58. The method according to claim 56, wherein introducing the distal end comprises inserting the distal end of the shaft into a blood vessel, and wherein tying the suture thread comprises closing the puncture in a blood vessel wall.

59. The method according to claim 58, wherein inserting the distal end of the shaft into the blood vessel comprises passing the distal end of the shaft through the puncture at an oblique angle relative to the blood vessel wall, and wherein ejecting the needles comprises passing the first and second needles through the blood vessel wall at respective first and second locations that are longitudinally spaced along a length of the blood vessel, so that the suture thread, when tied, is parallel to a longitudinal axis of the blood vessel.

60. The method according to claim 51, wherein deploying the needle guides causes the needle guides to curve out of the shaft so as to point in the proximal direction.

61. The method according to claim 60, wherein deploying the needle guides comprises pushing the needle guides out through the distal end of the shaft, whereupon the needle guides curve back in the proximal direction.

62. The method according to claim 60, wherein the needle guides comprise a superelastic material, which is formed so as to have a curved shape when deployed from the shaft.

63. The method according to claim 60 wherein the needles comprise an elastic material, which is formed so that the needles assume a straight shape upon being ejected from the needle guides.

64. The method according to claim 60, wherein deploying the needle guides comprises deploying one or more stabilizers, which are contained within the shaft while the needle guides are in the first operative configuration, so as to stabilize the needle guides in the second operative configuration.

65. The method according to claim 51, wherein the first and second needle guides are non-symmetrical in the second operative configuration.

66. The method according to claim 65, wherein the needle guides have respective outer ends, and comprising, after deploying the needle guides, bringing the outer ends of the first and second needle guides into simultaneous engagement with the tissue while the shaft is angled obliquely relative to the tissue, wherein ejecting the needles comprises ejecting the needles while the first and second needle guides are in the simultaneous engagement with the tissue and the shaft is angled obliquely.

67. The method according to claim 51, wherein the suture thread held by the first and second needles is a first thread, and wherein providing the shaft comprises providing third and fourth needle guides attached to the shaft and providing third and fourth needles, which are respectively held by the third and fourth needle guides and hold a second suture thread, and wherein the ejecting the needles comprises ejecting the first, second, third and fourth needles, thereby passing the ends of both the first and second suture threads through the tissue.

68. The method according to claim 67, wherein ejecting the first, second, third and fourth needles comprises making two parallel stitches through the tissue.

69. The method according to claim 67, wherein ejecting the first, second, third and fourth needles comprises making two crossed stitches through the tissue.

70. The method according to claim 51, wherein the needles are formed from a plate of a flat material.

71. The method according to claim 51, wherein each of the needles comprises a tube.

72. The method according to claim 51, wherein ejecting the needles comprises aiming the needles toward the shaft, and comprising capturing and holding the needles against the shaft after the needles have penetrated the tissue.

73. The method according to claim 72, wherein deploying the needle guides comprises configuring the needle guides to point the needles toward the shaft, so that the needles strike the shaft after passing through the tissue.

74. The method according to claim 51, wherein ejecting the needles comprises actuating an ejector so as to drive first and second ejector ends into the first and second needle guides, respectively, in order to eject the needles.

75. The method according to claim 74, wherein actuating the ejector comprises coupling the ejector to the needle guides so that the ejector cannot be actuated when the needle guides are in the second operative configuration.

76. The method according to claim 51, and comprising returning the needle guides to the first operative configuration after ejection of the needles, and withdrawing the shaft from the body while the needle guides are in the first operative configuration.

77. The method according to claim 76, wherein ejecting the needles comprises actuating an ejector, and wherein returning the needle guides comprises coupling the ejector to the needle guides so that actuation of the ejector causes the needle guides to return to the first operative configuration automatically.

78. The method according to claim 51, wherein providing the shaft comprises coupling a handle to the shaft, the handle comprising controls for use by an operator, and comprising, after ejecting the needles and removing the shaft from the body, releasing the shaft from the handle and replacing the shaft.

79. The method according to claim 51, wherein providing the shaft comprises holding the needle guides inside the shaft in the first operative configuration.

80. The method according to claim 79, wherein ejecting the needles comprises withdrawing the needle guides automatically into the shaft after ejection of the needles.

81. The method according to claim 51, wherein inserting the distal end comprises passing a cannula from a body surface through a puncture into the body cavity, and inserting the shaft through a lumen of the cannula.

82. The method according to claim 51, wherein the shaft contains a lumen, and wherein inserting the distal end comprises passing the shaft into the body cavity over the guide wire.

83. The method according to claim 51, wherein the shaft contains first and second lumens having respective first and second ports disposed along the shaft at different, respective longitudinal positions, and wherein inserting the shaft comprises observing a flow of a body fluid from the cavity through the first and second lumens in order to adjust a depth of insertion of the shaft inside the body cavity.

84-87. -87. (canceled)