CA2509720A1 - Puncture closure system with pin and pull technique - Google Patents

Puncture closure system with pin and pull technique Download PDF

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Publication number
CA2509720A1
CA2509720A1 CA002509720A CA2509720A CA2509720A1 CA 2509720 A1 CA2509720 A1 CA 2509720A1 CA 002509720 A CA002509720 A CA 002509720A CA 2509720 A CA2509720 A CA 2509720A CA 2509720 A1 CA2509720 A1 CA 2509720A1
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Canada
Prior art keywords
distance
cannula
pledget
pusher
bleed back
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CA002509720A
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French (fr)
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CA2509720C (en
Inventor
Mark Ashby
Eduardo Chi Sing
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Sub Q Inc
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Individual
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—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
    • A61B2017/00637—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 for sealing trocar wounds through abdominal wall
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—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
    • A61B2017/00646—Type of implements
    • A61B2017/00654—Type of implements entirely comprised between the two sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—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
    • A61B2017/00672—Locating means therefor, e.g. bleed back lumen

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

The present invention provides for a method and apparatus (100) to facilitate hemostasis at a blood vessel puncture site having a cannula (102) with a distal end (106), a proximal end (104), an inner diameter, and a lumen (110) extending between said distal end (106) and said proximal end (104); a bleed back port (112) located near the distal end (106); a pusher (116) having a top (118), a bottom (120), and a lumen (122) extending between the top (118) and bottom (120), the bottom (120) is slidably received into the cannula lumen (102); a bleed back exit port (126) located near the top (118); and a pledget (130) having a first end (132) and a second end (133), the first end (132) positioned at the distal end (106) within the cannula lumen (102), and the second end (133) positioned below the bleed back port (112).

Claims (81)

1. An apparatus to facilitate hemostasis at a blood vessel puncture site, comprising:
a cannula having a distal end, a proximal end, an inner diameter, and a lumen extending between said distal end and said proximal end;
a bleed back port located near said distal end;
a pusher having a top, a bottom, and a lumen extending between said top and said bottom, said bottom to be slidably received into said cannula lumen;
a bleed back exit port located near said top;
a pledget having a first end and a second end, said first end positioned at said distal end within said cannula lumen, said second end positioned below said bleed back port.
2. The apparatus of claim 1 further comprising a guidewire slidably received into said pusher lumen, said cannula lumen, said pledget, and said blood vessel puncture site.
3. The apparatus of claim 1 wherein said pusher bottom has a diameter substantially equal to or less than the inner diameter of said cannula.
4. The apparatus of claim 1 further comprising:
a first distance between said proximal end and said top;
a second distance between said bleed back port and said bottom;
a third distance between said distal end and said bleed back port; and a fourth distance between said first end and said second end.
5. The apparatus of claim 4 wherein said third distance is greater than or equal to said fourth distance and said first distance is greater or equal to a combination of said second and third distance.
6. The apparatus of claim 5 wherein said fourth distance is greater than said second distance such that when said pusher is in a fixed position and said cannula proximal end is pulled adjacent to said pusher top, said pledget first end is positioned within a wall of said blood vessel.
7. The apparatus of claim 5 wherein said fourth distance is less than said second distance such that when said pusher is in a fixed position and said cannula proximal end is pulled adjacent said pusher top, said pledget first end is positioned within a lumen of said blood vessel.
8. The apparatus of claim 5 wherein said fourth distance is equal to said second distance such that when said pusher is in a fixed position and said cannula proximal end is pulled adjacent to said pusher top, said pledget first end is positioned adjacent said blood vessel puncture site.
9. The apparatus of claim 1 wherein said pledget first end has a diameter substantially equal to the inner diameter of said cannula.
10. The apparatus of claim 1 wherein said pledget further comprises a hemostatic agent to chemically activate a clotting cascade.
11. The apparatus of claim 1 wherein said pledget further comprises a wetting agent.
12. The apparatus of claim 1 wherein said pledget further comprises a securing mechanism.
13. The apparatus of claim 12 wherein said securing mechanism is a bioadhesive agent.
14. The apparatus of claim 12 wherein said securing mechanism is coupled to said pledget first end.
15. The apparatus of claim 12 wherein said securing mechanism is coupled to said pledget second end.
16. The apparatus of claim 12 wherein said securing mechanism comprises at least one expandable prong.
17. The apparatus of claim 12 wherein said securing mechanism comprises at least one lateral projection.
18. The apparatus of claim 12 wherein said securing mechanism is expandable.
19. The apparatus of claim 12 wherein said securing mechanism is absorbable.
20. An apparatus to facilitate hemostasis at a blood vessel puncture site, comprising:
a cannula having a distal end, a proximal end, an inner diameter, and a lumen extending between said distal end and said proximal end;
a bleed back port located near said distal end;
a bleed back exit port located near said proximal end;
a pusher having a top and a bottom, said bottom to be slidably received into said cannula lumen;
a pledget having a first end and a second end, said first end positioned at said distalend within said cannula lumen, said second end positioned below said bleed back port.
21. The apparatus of claim 20 wherein said pusher bottom has a diameter equal to or less than the inner diameter of said cannula.
22. The apparatus of claim 20 further comprising:
a first distance between said proximal end and said top;
a second distance between said bleed back port and said bottom;
a third distance between said distal end and said bleed back port; and a fourth distance between said first end and said second end.
23. The apparatus of claim 22 wherein said third distance is greater than or equal to said fourth distance and said first distance is greater than or equal to a combination of said second and third distance.
24. The apparatus of claim 23 wherein said fourth distance is greater than said second distance such that when said pusher is in a fixed position and said cannula proximal end is pulled adjacent to said pusher top, said pledget first end is positioned within a wall of said blood vessel.
25. The apparatus of claim 23 wherein said fourth distance is less than said second distance such that when said pusher is in a fixed position and said cannula proximal end is pulled adjacent said pusher top, said pledget first end is positioned within a lumen of said blood vessel.
26. The apparatus of claim 23 wherein said fourth distance is equal to said second distance such that when said pusher is in a fixed position and said cannula proximal end is pulled adjacent to said pusher top, said pledget first end is positioned adjacent said blood vessel puncture site.
27 27. The apparatus of claim 20 wherein said pledget first end has a diameter substantially equal to the inner diameter of said cannula.
28. The apparatus of claim 20 wherein said pledget further comprises a wetting agent.
29. The apparatus of claim 20 wherein said pledget further comprises a securing mechanism.
30. The apparatus of claim 29 wherein said securing mechanism is a bioadhesive agent.
31. The apparatus of claim 29 wherein said securing mechanism is coupled to said pledget first end.
32. The apparatus of claim 29 wherein said securing mechanism is coupled to said pledget second end.
33. The apparatus of claim 29 wherein said securing mechanism comprises at least one expandable prong.
34. The apparatus of claim 29 wherein said securing mechanism comprises at least one lateral projection.
35. The apparatus of claim 20 wherein said pledget further comprises a hemostatic agent to chemically activate a clotting cascade.
36. The apparatus of claim 20 wherein said pusher bottom is initially positioned below said bleed back port and adjacent to said second end of said pledget.
37. The apparatus of claim 20 wherein said pusher bottom has a diameter less than or equal to said cannula inner diameter.
38. The apparatus of claim 20 wherein said pusher further comprises an extension between said top and said bottom wherein said extension has a small diameter to maximize space within said cannula lumen to maximize a flow of blood out of said bleed back exit port.
39. The apparatus of claim 20 wherein said pusher bottom is initially positioned above said bleed back port to maximize space within said cannula lumen to maximize a flow of blood out of said bleed back exit port.
40. A method for facilitating hemostasis at a blood vessel puncture site, comprising:
advancing a cannula into a blood vessel lumen, said cannula having a bleed back port at a distal end, a pledget having a first end and a second end, said pledget second end positioned below said bleed back port, and a pusher having a top and a bottom, said pusher bottom slidably received in a cannula lumen at a cannula proximal end;
withdrawing said cannula, said pledget, said bleed back port, and said pusher simultaneously until a blood flow no longer exists a bleed back exit port;
holding said pusher at a fixed position;
pulling said cannula proximal end toward said top of said pusher; and withdrawing said cannula and said pusher out of a tissue tract.
41. The method of claim 40 wherein said advancing further comprises inserting said cannula through a procedural sheath.
42. The method of claim 40 wherein said advancing further comprises inserting said cannula over a guidewire.
43. The method of claim 40 wherein said pusher further comprises a lumen extending between said top and said bottom.
44. The method of claim 43 wherein said bleed back exit port is located near said top.
45. The method of claim 40 wherein said pusher bottom has a diameter equal to or less than an inner diameter of said cannula.
46. The method of claim 40 wherein said bleed back port is located at said cannula proximal end.
47. The method of claim 40 further comprising:
measuring a first distance between said proximal end and said top;
measuring a second distance between said bleed back port and said bottom;
measuring a third distance between said distal end and said bleed back port;
and measuring a fourth distance between said first end and said second end.
48. The method of claim 47 wherein said third distance is greater than or equal to said fourth distance and said first distance is greater than or equal to a combination of said second and said third distance.
49. The method of claim 48 wherein said fourth distance is greater than said second distance such that when said pusher is in a fixed position and said cannula proximal end is pulled adjacent to said pusher top, said pledget first end is positioned within a wall of said blood vessel.
50. The method of claim 48 wherein said fourth distance is less than said second distance such that when said pusher is in a fixed position and said cannula proximal end is pulled adjacent said pusher top, said pledget first end is positioned within a lumen of said blood vessel.
51. The method of claim 48 wherein said fourth distance is equal to said second distance such that when said pusher is in a fixed position and said cannula proximal end is pulled adjacent to said pusher top, said pledget first end is positioned adjacent said blood vessel puncture site.
52. The method of claim 40 wherein said advancing further comprising positioning said bottom above said bleed back exit port.
53. The method of claim 52 wherein said holding further comprises repositioning said bottom at said second distance.
54. The method of claim 40 wherein said pusher further comprises an extension between said top and said bottom wherein said extension has a small diameter to maximize space within said lumen of said cannula to maximize said blood flow out of said bleed back exit port.
55. The method of claim 54 wherein said advancing further comprises positioning said bottom of said pusher below said bleed back port.
56. The method of claim 55 wherein said holding further comprises repositioning said bottom at said second distance.
57. The method of claim 40 wherein said pledget first end has a diameter substantially equal to the inner diameter of said cannula.
58. The method of claim 40 wherein said pledget further comprises a hemostatic agent to chemically active a clotting cascade.
59. The apparatus of claim 40 wherein said pledget further comprises a securing mechanism.
60. The apparatus of claim 59 wherein said securing mechanism is a bioadhesive agent.
61. The apparatus of claim 59 wherein said securing mechanism is coupled to said pledget first end.
62. The apparatus of claim 59 wherein said securing mechanism is coupled to said pledget second end.
63. The apparatus of claim 59 wherein said securing mechanism comprises at least one expandable prong.
64. The apparatus of claim 59 wherein said securing mechanism comprises at least one lateral projection.
65. The apparatus of claim 59 wherein said securing mechanism is expandable.
66. The apparatus of claim 59 wherein said securing mechanism is absorbable.
67. A method for facilitating hemostasis at a arteriotomy of a blood vessel further comprising:
positioning a first end of a pledget at a distal end of a cannula below a bleed back port, said bleed back port located adjacent said distal end of said cannula, wherein the distance between said first end of the pledget and said bleed back port is greater than a length of said pledget;
inserting a pusher into a lumen of said cannula, said pusher having a bottom and a top;
positioning said bottom above said bleed back port a distance P, wherein said distance P is equal to the distance of said length of said pledget;
advancing said cannula, said pledget, said bleed back port, and said pusher simultaneously into a lumen of said blood vessel;

withdrawing said cannula, said pledget, said bleed back port, and said pusher simultaneously until a blood flow no longer exists a bleed back exit port;
holding said pusher at a fixed position; and pulling a proximal end of said cannula adjacent said top of said pusher.
68. The method of claim 67 wherein said pulling further comprises retracting said cannula a distance greater than the combination of the distance P and the distance between the first end of the pledget and said bleed back port.
69. A method for facilitating hemostasis within the lumen of a blood vessel further comprising:
positioning a first end of a pledget at a distal end of a cannula below a bleed back port, said bleed back port located adjacent said distal end of said cannula, wherein the distance between said first end of the pledget and said bleed back port is greater than a length of said pledget;
inserting a pusher into a lumen of said cannula, said pusher having a bottom and a top;
positioning said bottom above said bleed back port a distance P, wherein said distance P is less than said length of said pledget;
advancing said cannula, said pledget, said bleed back port, and said pusher simultaneously into a lumen of said blood vessel;
withdrawing said cannula, said pledget, said bleed back port, and said pusher simultaneously until a blood flow no longer exists a bleed back exit port;
holding said pusher at a fixed position; and pulling a proximal end of said cannula adjacent said top of said pusher.
70. The method of claim 69 wherein said pulling further comprises retracting said cannula a distance greater than or equal to the combination of the distance P
and the distance between the first end of the pledget and said bleed back port.
71. A method for positioning a pledget adjacent a blood vessel puncture site further comprising:
positioning a first end of a pledget at a distal end of a cannula below a bleed back port, said bleed back port located adjacent said distal end of said cannula, wherein the distance between said first end of the pledget and said bleed back port is greater than a length of said pledget;
inserting a pusher into a lumen of said cannula, said pusher having a bottom and a top;
positioning said bottom above said bleed back port a distance P, wherein said distance P is greater than said length of the pledget;
advancing said cannula, said pledget, said bleed back port, and said pusher simultaneously into a lumen of said blood vessel;
withdrawing said cannula, said pledget, said bleed back port, and said pusher simultaneously until a blood flow no longer exists a bleed back exit port;
holding said pusher at a fixed position; and pulling a proximal end of said cannula adjacent said top of said pusher.
72. The method of claim 71 wherein said pulling further comprises retracting said cannula a distance greater than or equal to the combination of the distance P
and the distance between the first end of the pledget and said bleed back port.
73. A method for locating a hemostatic pledget at a blood vessel puncture site, comprising:
advancing a cannula into a tissue tract and into lumen of a blood vessel, said cannula having a bleed back port at a distal end, a pledget having a. first end and a second end, said pledget second end positioned below said bleed back port, and a pusher having a top and a bottom, said pusher bottom slidably received in a lumen of said cannula at a distal end;
withdrawing said cannula, said pledget, said bleed back port, and said pusher simultaneously until a blood flow no longer exists a bleed back exit port;
advancing said pusher a distance R; and withdrawing said cannula and said pusher simultaneously out of said tissue tract.
74. The method of claim 73 further comprises securing said pledget within said lumen of said blood vessel.
75. The apparatus of claim 74 wherein said securing further comprises a bioadhesive agent.
76. The apparatus of claim 74 wherein said securing further comprises at least one expandable prong.
77. The method of claim 76 wherein said distance R is equal to or greater than a length of said at least one expandable prong.
78. The method of claim 76 wherein said at least one expandable prong is absorbable.
79. The method of claim 74 wherein said securing comprises at least one lateral projection.
80. The method of claim 79 wherein said distance R is a length of said at least one lateral projection
81. The method of claim 79 wherein said at least one lateral projection is absorbable.
CA2509720A 2003-04-22 2004-04-19 Puncture closure system with pin and pull technique Expired - Fee Related CA2509720C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US42168003A 2003-04-22 2003-04-22
US10/421,680 2003-04-22
PCT/US2004/012065 WO2004093649A2 (en) 2003-04-22 2004-04-19 Puncture closure systeme with pin and pull technique

Publications (2)

Publication Number Publication Date
CA2509720A1 true CA2509720A1 (en) 2004-11-04
CA2509720C CA2509720C (en) 2012-10-16

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CA2509720A Expired - Fee Related CA2509720C (en) 2003-04-22 2004-04-19 Puncture closure system with pin and pull technique

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EP (1) EP1615540A4 (en)
JP (1) JP4653083B2 (en)
CA (1) CA2509720C (en)
WO (1) WO2004093649A2 (en)

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US9131932B2 (en) * 2013-02-01 2015-09-15 St. Jude Medical Puerto Rico Llc Dual lumen carrier tube with retractable sleeve and methods
KR102045030B1 (en) * 2013-02-08 2019-11-15 재단법인 아산사회복지재단 Vascular sheath having hemostatic component

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Also Published As

Publication number Publication date
WO2004093649A2 (en) 2004-11-04
CA2509720C (en) 2012-10-16
WO2004093649A3 (en) 2005-03-17
JP2006524111A (en) 2006-10-26
EP1615540A2 (en) 2006-01-18
JP4653083B2 (en) 2011-03-16
EP1615540A4 (en) 2011-07-20

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