Device and method for suturing internal structures puncture wounds

• US 20060142784A1
• Filed: 03/30/2005
• Published: 06/29/2006
• Est. Priority Date: 12/28/2004
• Status: Abandoned Application

• Current Assignee: Stavros Kontos
• Original Assignee: Stavros Kontos
• Inventors: Kontos, Stavros
• Application Number:
  US11/092,856
• Publication Number:
  US 20060142784A1
• Time in Patent Office: Days
• US Class Current: 606/139
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0057 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0417 T-fasteners
• 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 2017/0475 using sutures having a slip knot
• CPC Class Codes: A61B 2017/0477 with pre-tied sutures
• CPC Class Codes: A61B 2017/0496 for tensioning sutures

Abstract

A device for remotely suturing an internal structure of a body and a method of performing said suturing procedure. The device includes one or more anchors and means, operable from outside the body, for forcing said anchors out of said device. The anchors are located in or on said device so that they can be positioned adjacent said internal structure and when forced out of said device, enter and pass through said structure. The anchors are further provided with sutures that can be tightened from outside of the body to secure the anchors in place. In one aspect of the invention, tightening the suture or sutures pulls the anchors toward one another, thereby closing a wound in said internal structure. In another aspect of the invention, tightening of the sutures secures a prosthetic device in place.

Claims

1. A device for remotely suturing an internal structure of a body comprising an insertion device having a proximal end and a distal end, one or more anchors slidably held in recesses in said device, each of said anchor recesses being associated with an anchor ejection opening, at least one suture connected to said anchors, said at least one suture being sufficiently long as to reach from said internal structure to the outside of said body, and means for ejecting said anchors from said recesses through said anchor ejection openings, said anchor ejecting means being operable from outside said body, said anchor ejection means being adapted to puncture said internal structure and means to permit securing said anchors in place against said internal structure when the operator pulls said at least one of said sutures.

2. The device of claim 1 wherein said anchor rejection recesses are comprised of hollow needles and wherein said hollow needles also comprise said means for puncturing said internal structure.

3. The device of claim 1 further comprising a slide mechanism on said suture to permit said operator to pull the same tight.

4. The device of claim 3 further comprising means for locking said suture in position after it has been pulled tight.

5. The device of claim 3 wherein said slide mechanism is comprised of a slip knot.

6. The device of claim 3 wherein said slide mechanism is comprised of a crimp ferrule.

7. The device of claim 1 wherein said device is provided with a guidewire lumen adapted to slide over a guidewire.

8. The device of claim 1 wherein said ejecting means are comprised of one movement rod associated with each anchor, said device further comprising pushrod retaining means, said movement rods being slidably retained in said movement rod retaining means and further comprising operating means for enabling an operator, from outside said body, to cause said movement rods to move in said retaining means.

9. The device of claim 8 wherein each of said movement rod retaining means are comprised of a lumen in said device, each of said lumens communicating with one of said recesses.

10. The device of claim 1 wherein said anchors are provided with means for preventing retraction thereof after said anchors have passed through said structure.

11. The device of claim 10 wherein said retraction prevention means are comprised of barbs on said anchors.

12. The device of claim 11 wherein said barbs protrude from the peripheries of said anchors.

13. The device of claim 1 further comprising locator means for enabling the operator to determine, from outside said body, when said device is properly located with respect to said structure.

14. The device of claim 13 wherein said locator means comprises an indicator lumen having distal and proximal openings, said distal opening of said indicator lumen located distally of said anchor ejection openings and said proximal opening of said indicator lumen located outside said body whereby the operator can see fluid emerging therefrom when said distal end is inside the structure.

15. The device of claim 13 wherein said locator means comprises an indicator lumen having distal and proximal openings, said distal opening of said indicator lumen located proximally of said anchor ejection openings and said proximal opening of said indicator lumen located outside said body whereby the operator can see fluid emerging therefrom when said distal end is inside the structure.

16. The device of claim 13 wherein said locator means comprises a barb operable from outside said body to move said locating barb from a retracted position to a deployed position, wherein when in its retracted position said barb is housed within said device and when in its deployed position said locator barb protrudes and splays outwardly from the body of said insertion device, whereby said locator barb, when in its deployed position, engages the wall of said internal organ when said device is properly located in said body whereby the operator can feel said wall engagement of said locator barb, thereby knowing said insertion device is properly located.

17. The device of claim 2 further comprising needle movement means for causing said needles to puncture said internal structure and anchor movement means for causing said anchors to exit said needles after said needles have punctured said structure.

18. The device of claim 17 wherein said needle movement means are comprised of one movement rod associated with each needle, said device further comprising needle movement rod retaining means, wherein said needle movement rods are slidably retained in said needle rod retaining means and further comprising needle operating means for enabling an operator, from outside said body, to cause said needle movement rods to move in said needle movement rod retaining means.

19. The device of claim 18 wherein said anchor movement means are comprised of one anchor movement rod associated with each of said anchors, said device further comprising anchor movement rod retaining means, wherein said anchor movement rods are slidably retained in said anchor movement rod retaining means, and further comprising anchor operating means for enabling an operator, from outside said body, to cause said anchor movement rods to move in said anchor movement rod retaining means.

20. The device of claim 1 having two or more anchors wherein said anchor ejection openings are spaced approximately equidistant around the periphery of said device.

21. The device of claim 17 further comprising locator means for enabling the operator to determine, from outside said body, when said device is properly located with respect to said structure.

22. The device of claim 1 having two anchors.

23. The device of claim 22 wherein said anchor ejection openings are spaced approximately 180°

apart around the periphery of said device.

24. The device of claim 1 having three anchors.

25. The device of claim 24 wherein said anchor ejecting openings are spaced approximately 120°

apart around the periphery of said device.

26. The device of claim 1 having four anchors.

27. The device of claim 26 wherein said anchor ejecting openings are space approximately 90°

apart around the periphery of said device.

28. The device of claim 1 further comprising an expansion section on which said anchor recesses are housed, said expansion section being expandable from a collapsed position to an expanded position.

29. The device of claim 28 wherein said expansion section is comprised of an inflatable balloon.

30. The device of claim 28 wherein said expansion section is self expanding from said collapsed position to said expanded position.

31. The device of claim 28 wherein said expansion section is comprised of a scaffold having multiple struts.

32. The device of claim 8 wherein said operating means causes all of said pushrods to move substantially simultaneously.

33. The device of claim 8 wherein said operating means enables said pushrods to be moved independently.

34. The device of claim 1 comprising at least two anchors wherein said device is rotatable from a first position to a second position while inside said body, said device adapted to have one of said anchors ejected from an anchor ejection opening when said device is in said first position and to have another of said anchors ejected from an ejection opening when said device is in said second position.

35. The device of claim 34 wherein there is only one anchor ejection opening and wherein said anchors are stored in said device for seriatim discharge through said ejection opening, further comprising means for ejecting one anchor when said device is in said first position, means for readying a second anchor for ejection after said first anchor has been ejected.

36. The device of claim 34 comprising two or more suture anchors slidably held in recesses in said device, at least one of said anchor recesses communicating with an anchor ejection opening, a suture connecting said anchors, means for ejecting said suture anchors from said recesses through at least one of said anchor ejection openings, said suture anchors being adapted to puncture said internal structure, a stabilizer resident in a lumen of said device, said stabilizer comprising an operating handle adapted to move said stabilizer from a retracted position to a deployed position and from said deployed position to said retracted position and further comprising a stabilizing anchor adapted, when said device is in said first position, to stabilize a first section of said internal structure when said stabilizer is moved from said retracted position to said deployed position and to hold said first section of said structure relatively stable while said stabilizer is in said deployed position, said ejecting means adapted to eject at least one of said suture anchors through one of said ejection openings and into and through said first section of said internal structure while said stabilizing anchor is stabilizing said first section, said stabilizing anchor adapted to release said first section of said internal structure when said stabilizer is moved to said retracted position, said stabilizing anchor adapted to stabilize a second section of said internal structure when said device has been rotated to said second position and said stabilizer has been moved to said deployed position, means for ejecting at least a second suture anchor through an ejection opening and causing said second suture anchor to puncture said second section, said stabilizing anchor adapted to release said second section of said internal structure when said stabilizer is moved to said retracted position, a slide mechanism on said suture to permit pulling said anchors toward one another when tension is applied to one or both ends of said suture.

37. The device of claim 36 wherein said stabilizing anchor is adapted to stabilize said internal structure by piercing the same and holding it impaled on said stabilizing anchor.

38. The device of claim 36 wherein said stabilizing anchor is adapted to stabilize said internal structure by having suction applied through said stabilizing anchor to said structure to hold same against said stabilizing anchor.

39. The device of claim 36 wherein said slide mechanism is comprised of a slip knot on said suture.

40. The device of claim 36 wherein said slide mechanism is comprised of a crimp ferrule.

41. The device of claim 1 wherein said anchors are slidably mounted on a common suture.

42. The device of claim 1 wherein each of said anchors is mounted on its own suture.

43. The device of claim 1 further comprising a stabilizing anchor operable from outside said body to move said stabilizing anchor from a retracted position to a deployed position.

44. The device of claim 43 wherein when said stabilizing anchor is in its retracted position, it is housed within a lumen of said device.

45. The device of claim 43 wherein said stabilizing anchor is operable from outside said body to move said stabilizing anchor from said deployed position to said retracted position.

46. The device of claim 43 further comprising an lumen communicating from outside said body through said stabilizer and said stabilizing anchor and opening at the end of said stabilizing anchor wherein said lumen can be used to apply suction to said structure when the same is in contact with said stabilizing anchor whereby said structure is stabilized.

47. The device of claim 43 further comprising a guidewire lumen.

48. The device of claim 1 wherein said device is designed to close an opening in said internal structure.

49. The device of claim 48 wherein said device is comprised of at least two anchors, wherein all of said anchors are mounted on a common suture and wherein when the operator pulls said suture tight said anchors are pulled toward one another, thereby closing said opening.

50. The device of claim 1 further comprising a prosthetic device mounted on said at least one suture, wherein when said operator pulls on said suture, said prosthetic device is secured in place on said internal structure.

51. The device of claim 50 wherein said device is comprised of at least two anchors, wherein all of said anchors are mounted on a common suture and wherein when said operator pulls said suture tight said anchors are secured to said structure, thereby securing said prosthesis in place.

52. The device of claim 50 wherein said device is comprised of at least two anchors, wherein each of said anchors is mounted on its own suture and wherein when said operator pulls said sutures tight said anchors are secured to said structure, thereby securing said prosthesis in place.

53. The device of claim 1 wherein said device is designed to reinforce a weakened portion of said internal structure by suturing a sheet material to said internal structure over said weakened portion, thereby to reinforce said portion.

54. The device of claim 53 wherein said device is comprised of at least two anchors, wherein all of said anchors are mounted on a common suture and wherein when said operator pulls said suture tight said anchors are secured to said structure, thereby securing said sheet material in place.

55. The device of claim 53 wherein said device is comprised of at least two anchors, wherein each said anchors is mounted on its own suture and wherein when said operator pulls said sutures tight said anchors are secured to said structure, thereby securing said sheet material in place.

56. The device of claim 53 further comprising locator means for enabling the operator to determine, from outside said body, when said device is properly located with respect to said structure.

57. The device of claim 56 wherein said locator means comprises an indicator lumen having distal and proximal openings, said distal opening of said indicator lumen located distally of said anchor ejection openings and said proximal opening of said indicator lumen located outside said body whereby the operator can see fluid emerging therefrom when said distal end is inside the structure.

58. The device of claim 56 wherein said locator means comprises an indicator lumen having distal and proximal openings, said distal opening of said indicator lumen located proximally of said anchor ejection openings and said proximal opening of said indicator lumen located outside said body whereby the operator can see fluid emerging therefrom when said distal end is inside the structure.

59. The device of claim 56 wherein said locator means comprises wherein said locator means comprises a barb operable from outside said body to move said locator barb from a retracted position to a deployed position, wherein when in its retracted position said barb is housed within said device and when in its deployed position said locator barb protrudes and splays outwardly from the body of said insertion device, whereby said locator barb, when in its deployed position, engages the wall of said internal organ when said device is properly located in said body whereby the operator can feel said wall engagement of said locator barb, thereby knowing said insertion device is properly located.

74. The device of claim 1 wherein said device is designed to have said anchor ejection openings located on the outside of said structure when said anchors are ejected.

75. The device of claim 74 wherein said device is adapted to have said anchors puncture said structure from the outside thereof to the inside thereof and wherein said anchors remain inside said structure when said operator pulls said at least one said suture.

76. The device of claim 1 wherein said device is designed to have said anchor ejection openings pass into said internal structure before said anchors are ejected therefrom.

77. The device of claim 76 wherein said anchor ejection means are adapted to puncture said structure from the inside thereof to the outside thereof and wherein said anchors remain outside said structure when said operator pulls said at least one said suture.

60. A method for remotely suturing, from outside a body, an internal structure in said body, comprising the steps of:

a. from outside of said body, inserting into said body a device comprising at least one anchor, at least one suture, at least one anchor recess and at least one anchor ejection opening,

b. positioning said device so that at least one of said anchor ejection openings is adjacent said structure,

c. puncturing a hole in said anatomical structure;

d. causing an anchor to exit at least one of said anchor ejection openings and pass through one of said puncture holes in said anatomical structure, each of said anchors being mounted on a suture,

e. withdrawing said device from said body, leaving at least one of said anchors mounted on said at least one suture adjacent said structure, and

f. from outside of the said body, tightening said at least one suture to secure said anchors in place.

61. The method of claim 60 wherein said anchors are slidably mounted on a common suture having two ends and wherein the ends of said suture are slidably connected outside of said structure, applying tension to one end of said at least one suture to secure said anchors in place.

62. The method of claim 60 wherein there are at least two anchors, further comprising the steps of positioning said ejection openings adjacent a wound in said structure, causing non-adjacent puncture holes to be made in said structure, tightening up on said suture to draw said anchors toward one another, thereby repairing said wound.

63. The method of claim 62 wherein there are three anchors, further comprising the step of causing said anchors to pass through their respective puncture holes in said structure spaced approximately 120°

from one another.

64. The method of claim 62 wherein there are four anchors further comprising the step of causing said anchors to pass through their respective puncture holes in said structure spaced approximately 90°

from one another.

65. The method of claim 62 wherein said anchors are caused to exit said anchor ejection openings approximately simultaneously.

66. The method of claim 62 wherein said anchors are caused to exit said ejection openings independently.

67. The method of claim 60 further comprising the step of inserting said device into said body until locator means indicate that said device is properly located adjacent said structure.

68. The method of claim 62 further comprising the step of exerting, from outside said body, distal force on at least one movement member to cause said anchors to exit said anchor ejection openings.

69. The method of claim 68 wherein said force is applied to said movement members by moving a common operating handle to which all movement members are attached.

70. The method of claim 60 further comprising the steps of, before ejecting said anchors, enlarging an expansion section of said device and centering said expansion section in an opening in said structure.

71. The method of claim 70 wherein said expansion section is comprised of a balloon and further comprising the step of expanding said section by inflating said balloon.

72. The method of claim 70 wherein said expansion section is comprised of a multi-strut scaffold and further comprising the steps of applying force to collapse said section before inserting said device into said body and expanding said scaffold when said device is properly located in said body.

73. The method of claim 72 wherein said scaffold is self-expanding and wherein the step of expanding said scaffold is accomplished by releasing said force.

78. The method of claim 60 wherein said structure has a wall, wherein said positioning step places said at least one ejection opening outside of said wall of said structure, wherein said puncture step is accomplished by having said at least one said anchor, when it exits said at least one ejection opening, make its own hole in said wall of said structure from the outside thereof to the inside thereof, and wherein said withdrawing step leaves said at least one anchor inside said wall of said structure.

79. The method of claim 60 wherein said structure has a wall, wherein said positioning step places said at least one ejection opening inside of said wall of said structure, wherein when said at least one said anchor exits said at least one ejection opening it makes its own hole in said wall of said structure from the inside thereof to the outside thereof, and wherein said withdrawing step leaves said at least one anchor outside said wall of said structure.

80. The method of claim 60 wherein said structure has a wall defining the perimeter thereof, wherein said positioning step places said at least one said ejection opening outside of said wall of said structure, wherein said puncturing step is accomplished by forcing at least one needle through said wall from the outside thereof to the inside thereof, thereby making a puncture hole for at least one of said anchors, and wherein said withdrawing step leaves said at lease one anchor inside said structure.

81. The method of claim 60 wherein said structure has a wall defining the perimeter thereof, wherein said positioning step places said at least one said ejection opening inside of said wall of said structure, wherein said puncturing step is accomplished by forcing at least one needle through said wall from the inside thereof to the outside thereof, thereby making a puncture hole for at least one of said anchors, and wherein said withdrawing step leaves said at lease one anchor outside said structure.