Suturing device and method

• US 20020045908A1
• Filed: 06/14/2001
• Published: 04/18/2002
• Est. Priority Date: 08/24/1995
• Status: Active Grant

• Current Assignee: Scarab Technology Services, LLC
• Original Assignee: Sutura Incorporated
• Inventors: Decker, Steven E., Nobles, Anthony A., Brosch, Benjamin G.
• Granted Patent: US 6,562,052 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 17/0491 Sewing machines for surgery
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/2911 rings

Abstract

A suturing device and method allows a physician to remotely suture biological tissue. The device includes an elongate body, first and second arms operably connected to the elongated body, whereby each arm mounts an end portion of a suture, and first and second needles, each needle having a distal end and being mounted such that the distal end of the needle is movable to engage respective end portions of said suture. The suturing apparatus further includes an actuator which drives the needles to engage the suture non-simultaneously.

Claims

1. A suturing apparatus, comprising:

an elongate body;

first and second arms, each of said arms having a suture mounting portion which mounts an end portion of a suture, said arms being mounted on the elongate body such that said suture mounting portions are movable away from said body to a first position and towards said body to a second position;

first and second needles, each of said needles having a distal end, and being mounted such that the distal end of the needle is movable (i) in a proximal to distal direction from a position adjacent said elongate body to a position spaced outwardly from said body and (ii) towards the suture mounting portion of one of the arms when in said first position, wherein the respective distal ends of the first and second needles engage respective end portions of said suture; and

an actuator which drives the needles in said proximal to distal direction such that the engagement of the respective end portions of the suture is non-simultaneous.

2. The apparatus of claim 1, wherein said actuator comprises a pair of independently movable needle drivers coupled to independently advance said needles, respectively, in said proximal to distal direction.

3. The apparatus of claim 2, wherein said needle drivers are slidably coupled to one another.

4. A suturing apparatus, comprising:

an elongate body;

first and second arms, each of said arms having a suture mounting portion which mounts an end portion of a suture, said arms being operably connected to the elongate body such that said suture mounting portions are movable away from said body to a first position and towards said body to a second position;

first and second needles, each of said needles having a distal end, and being mounted such that the distal end of the needle is movable (i) in a proximal to distal direction from a position adjacent said elongate body to a position spaced outwardly from said body and (ii) towards the suture mounting portion of one of the arms when in said first position; and

an actuator comprising first and second needle drivers connected to drive the first and second needles, respectively, in said proximal to distal direction, said needle drivers being independently actuable such that the first needle is movable independent of the second needle.

5. A device for suturing biological tissue, comprising:

an elongated body;

an arm operably connected to the elongated body to move to an extended position away from the elongated body and to a retracted position toward the elongated body, the arm having a mounting portion which mounts a portion of a suture, and having a tissue contacting surface which faces proximally when the arm is in the extended position, said tissue contacting surface having a projecting portion configured to provide intimate contact with said tissue and to thereby inhibit lateral movement of said arm when said tissue contacting surface is pressed against tissue; and

a needle having a distal end which is movable distally from a position adjacent the elongated body towards said mounting portion of said arm when the arm is in the extended position, such that said distal end engages said portion of the suture mounted by said mounting portion.

6. The device of claim 5, wherein the projecting portion is defined by a curvature in the tissue contacting surface of the arm.

7. The device of claim 5, wherein the projecting portion is at an end of the arm.

8. The device of claim 5, wherein the projecting portion is small compared to the area of the tissue contacting surface of the arm.

9. The device of claim 5, wherein the projecting portion is in proximity to the mounting portion of the arm.

10. The device of claim 5, wherein the distal end of the needle follows a path which diverges from a central axis of the elongated body.

11. The device of claim 5, further comprising:

a second arm operably connected to the elongated body to move to an extended position away from the elongated body and to a retracted position toward the elongated body, the second arm having a mounting portion which mounts a second portion of said suture, and having a tissue contacting surface which faces proximally when the second arm is in the extended position; and

a second needle having a distal end which is movable from a position adjacent the elongated body towards the mounting portion of the second arm when the second arm is in the extended position, such that the distal end engages the second portion of the suture mounted by the mounting portion of the second arm.

12. The device of claim 11, wherein the second tissue contacting surface has a projecting portion configured to provide intimate contact with said tissue and to thereby inhibit lateral movement of said second arm.

13. The device of claim 12, wherein the projecting portion of the second tissue contacting surface is at an end of the second arm.

14. The device of claim 12, wherein the projecting portion of the second tissue contacting surface is small compared to the area of the second tissue contacting surface.

15. The device of claim 12, wherein the projecting portion of the second tissue contacting surface is in proximity to the mounting portion of the second arm.

16. The device of claim 11, wherein the first needle and second needle are configured to move simultaneously.

17. The device of claim 11, wherein the first needle and second needle are configured to move at different times.

18. The device of claim 11, wherein the first needle engages the first portion of the suture before the second needle engages the second portion of the suture.

19. The device of claim 11, wherein the first needle engages the first portion of the suture before the second needle moves towards the mounting portion of the second arm.

20. The device of claim 11, wherein the first arm and second arm are configured to move at different times.

21. The device of claim 5, further comprising:

second, third, and fourth arms operably connected to the elongated body to move to an extended position away from the elongated body and to a retracted position toward the elongated body, the second arm having a mounting portion which mounts a second portion of said suture, the third and fourth arms each having a mounting portion which respectively mounts a first and second portion of a second suture, and the second, third, and fourth arms each having a tissue contacting surface which faces proximally when the respective arm is in the extended position; and

second, third and fourth needles each having a distal end which is movable from a position adjacent the elongated body towards the mounting portions of the second, third, and fourth arms, respectively, when the respective arm is in the extended position, such that the distal end of each needle engages the portion of the sutures mounted by the mounting portion of the respective arm and to thereby inhibit lateral movement of the respective arm when the tissue contacting surface is pressed against the tissue.

22. The device of claim 21, wherein the tissue contacting surface of each arm has a projecting portion configured to provide intimate contact with said tissue and to thereby inhibit lateral movement of the respective arm.

24. The suturing apparatus of claim 23, wherein the patch is stored within the elongated body for deployment from a distal end portion of the elongated body.

25. The suturing apparatus of claim 23, wherein the patch comprises a flexible piece of synthetic material or natural tissue.

27. The method of claim 26, further comprising moving the first arm away from the elongate body, and moving the second arm away from the elogate body.

28. The method of claim 27, wherein the first arm is moved away from the elongate body before the second arm is moved away from the elongate body.

29. The method of claim 26, wherein the first needle drives towards the first arm before the second needle engages the second portion of the suture.

30. The method of claim 26, wherein the first needle drives towards the first arm before the second needle drives towards the second arm.

31. The method of claim 26, wherein engaging the first portion of the suture with the first needle comprises penetrating a tissue structure with the first needle.

32. The method of claim 31, wherein engaging the second portion of the suture with the second needle comprises penetrating a second tissue structure with the second needle.

33. The method of claim 31, wherein engaging the second portion of the suture with the second needle comprises extending the second needle along a side of a second tissue structure, such that the second arm, second needle, and elongate body encircle the second tissue structure.

34. The method of claim 31, wherein engaging the second portion of the suture with the second needle comprises extending the second needle along a side of an implantable material, such that the second arm, second needle, and elongate body encircle the implantable material.

35. The method of claim 34, wherein the implantable material comprises synthetic material.

36. The method of claim 34, wherein the implantable material comprises natural tissue.

37. The method of claim 26, wherein engaging the second portion of the suture with the second needle comprises penetrating a tissue structure with the second needle.

38. The method of claim 37, wherein engaging the first portion of the suture with the first needle comprises extending the first needle along a side of a second tissue structure, such that the first arm, first needle, and elongate body encircle the second tissue structure.

39. The method of claim 37, wherein engaging the first portion of the suture with the first needle comprises extending the first needle along a side of an implantable material, such that the first arm, first needle, and elongate body encircle the implantable material.

40. The method of claim 39, wherein the implantable material comprises synthetic material.

41. The method of claim 39, wherein the implantable material comprises natural tissue.

42. The method of claim 26, wherein engaging the first portion of the suture with the first needle comprises extending the first needle along a side of a first tissue structure, such that the first arm, first needle, and elongate body encircle the first tissue structure and engaging the second portion of the suture with the second needle comprises extending the second needle along a side of a second tissue structure, such that the second arm, second needle, and elongate body encircle the second tissue structure.

43. The method of claim 26, wherein engaging the first portion of the suture with the first needle comprises extending the first needle along a side of a first tissue structure, such that the first arm, first needle, and elongate body encircle the first tissue structure and engaging the second portion of the suture with the second needle comprises extending the second needle along a side of an implantable material, such that the second arm, second needle, and elongate body encircle the implantable material.

23. A suturing apparatus comprising:

an elongated body;

an arm operably connected to the elongated body and movable relative to the elongated body to an extended position away from the elongated body and to a retracted position towards the elongated body, the arm having a mounting portion which mounts a portion of a suture;

a needle movable relative to the elongated body, the needle having a distal end movable from a position adjacent the elongated body towards the mounting portion of the arm when the arm is in the extended position, such that the distal end engages the portion of the suture mounted by the mounting portion of the arm; and

a patch which is tethered by the suture.

26. A method of suturing comprising:

providing an elongate body having first and second arms which mount first and second portions, respectively, of a suture;

engaging the first and second portions of the suture with first and second needles, respectively, by driving the first and second needles towards the first and second arms, respectively, in a proximal to distal direction, the engaging comprising engaging the first portion of suture with the first needle prior to engaging the second portion of the suture with the second needle.

44. A method of occluding a septal defect, the method comprising:

inserting a distal end portion of an elongated body into an opening in a living being;

positioning the distal end portion in a first location adjacent a first tissue portion in proximity to the septal defect;

deploying a first needle within the elongated body so as to draw a first end of a suture through the first tissue portion;

moving the distal end portion to a second location displaced from the first location and positioning the distal end portion adjacent a second tissue portion in proximity to the septal defect;

deploying a second needle within the elongated body so as to draw a second end of the suture through the second tissue portion; and

using the suture to secure a patch across the septal defect.

45. The method of claim 44, wherein securing the patch comprises pulling the ends of the suture to draw the patch against the first and second tissue portions.

46. The method of claim 44, wherein the septal defect is a congenital heart defect.

47. The method of claim 44, wherein using the suture to secure the patch across the septal defect comprises:

deploying the patch from the distal end of the elongated body, the patch being preloaded and threaded onto the suture; and

pulling the suture and sliding a knot or clip toward the septal defect to securely hold the patch in place.

48. The method of claim 44, wherein using the suture to secure the patch across the septal defect comprises:

passing the first and second ends of the suture through the patch;

pushing the patch distally along the suture toward the septal defect; and

pulling the suture and sliding a knot or clip toward the septal defect to securely hold the patch in place.

50. The method of claim 49, wherein using the suture to secure a patch to the first and second tissue portions comprises pulling the suture through the patch prior to inserting the distal end portion of the elongated body into the opening in the living being.

51. The method of claim 49, wherein the method further comprises:

pushing the patch distally along the suture to be in proximity to the first and second tissue portions; and

occluding a space between the first and second tissue portions by sliding a knot or clip toward the patch to securely hold the patch in place.

49. A method of suturing, comprising:

inserting a distal end portion of an elongated body into an opening in a living being;

positioning the distal end portion in a first location adjacent a first tissue portion;

deploying a first needle within the elongated body so as to draw a first end of a suture through the first tissue portion;

moving the distal end portion to a second location displaced from the first location and positioning the distal end portion adjacent a second tissue portion;

deploying a second needle within the elongated body so as to draw a second end of the suture through the second tissue portion; and

using the suture to secure a patch to the first and second tissue portions.

52. A method of suspending a biological structure, comprising:

positioning a distal portion of an elongated body adjacent the biological structure to be suspended;

positioning a first arm operably connected to the elongated body on one side of the biological structure, the first arm releasably holding a first end portion of a suture;

extending a first needle toward the first end portion of the suture in the first arm, the first needle moving on an opposite side of the biological structure such that when the first needle engages the first end portion of the suture, the biological structure is encircled by the first arm, the first needle, and the elongated body;

positioning a second arm operably connected to the elongated body adjacent a tissue portion, the second arm releasably holding a second end portion of the suture;

extending a second needle through the tissue portion to engage the second end portion of the suture in the second arm;

drawing the first end portion and second end portion of the suture toward the elongated body; and

tying the first end portion and second end portion of the suture to suspend the biological structure to the tissue portion.

53. A method of placing a suture around the exterior of a biological structure, the method comprising:

advancing an elongate suturing device having an elongate body distally towards the biological structure;

positioning a first suture portion mounted on the elongate device so that the first suture portion is proximate the biological structure;

advancing a suture retrieving member of the elongate device past the biological structure without piercing the biological structure, said advancing comprising moving the suture retrieving member with the biological structure between the suture retrieving member and the elongate body, said advancing further comprising coupling the suture retrieving member to the first suture portion;

drawing the first suture portion away from the biological structure by moving the suture retrieving member in a direction away from the biological structure; and

drawing a second suture portion away from the biological structure by moving at least a portion of the elongate device from the biological structure, whereby the suture extends in a loop around the biological structure.

54. The method of claim 53, wherein advancing the suture retrieving member past the biological structure comprises moving the suture retrieving member in a distal to proximal direction, and drawing the first suture portion away from the biological structure comprises moving the suture retrieving member in a proximal direction.

55. The method of claim 53, wherein advancing the suturing device distally towards the biological structure comprises advancing the suturing device into a body cavity of a living being.

56. The method of claim 55, wherein the biological structure comprises a synthetic material.

57. The method of claim 53, wherein the first and second suture portions are mounted on respective arms extending from the elongate body.

58. The method of claim 53, wherein the biological structure comprises an elongate structure.

59. The method of claim 58, wherein the elongate structure comprises a ligament.

60. The method of claim 53, further comprising tying the first and second suture portions together to form a knot.

61. The method of claim 53, wherein the suture retrieving member comprises a needle.