Method and device for providing hemostasis at vascular penetration sites

• US 6,117,145 A
• Filed: 10/16/1997
• Issued: 09/12/2000
• Est. Priority Date: 06/01/1994
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Perclose Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wood, Timothy J., Andreas, Bernard H.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): KING, ANTHONY S
• Application Number:
  US08/951,985
• Time in Patent Office: 1,062 Days
• Field of Search: 606/148, 606/139, 606/144, 606/145, 606/113
• US Class Current: 606/148
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00641 for closing fistulae, e.g. anorectal fistulae
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/0474 Knot pushers
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61L 24/106 Fibrin; Fibrinogen

Abstract

A device for providing or enhancing hemostasis at a vascular puncture site disposed at the distal end of a tissue tract comprises a shaft having a non-compliant surface at its distal end. The non-compliant surface is oriented at an angle which allows it to lie flat over tissue puncture when the tissue tract is oriented obliquely, e.g., as the result of the Seldinger catheter introduction technique. The device may be used by itself or in combination with suturing of the vascular puncture, where the device enhances hemostasis and prevents blood leakage through the primary suture closure.

Claims

1. A blood vessel puncture occlusion device for occluding a puncture of a blood vessel having a vessel wall with an adventitial surface, said device comprising:

a shaft having a proximal end, a distal end, and a distally oriented surface at its distal end, wherein the surface is generally circular or elliptical, has an area in the range from 6 mm² to 30 mm², and is oriented at an angle from 30°

to 60°

relative to the axis of the shaft, the surface having an opening and engaging the adventitial surface about the puncture with a hemostasis-inducing pressure; and

a suture passing through the vessel wall adjacent to and outside the puncture, the suture having two free ends movable relative to the shaft so as to tension the suture proximally from the vessel wall through the opening an along the shaft; and

proximal anchor means disposed near the proximal end of the shaft, the anchor means comprising means for receiving the ends of the suture after the ends move and the suture is tensioned, and means for ane the tensioned suture relative to the shaft so that the tensioned suture urges the adventitial surface proximally against the surface of the shaft.

2. A device as in claim 1, wherein the shaft is a cylinder and the surface is a planar section through the cylinder at said angle.

3. A device as in claim 1, wherein the surface is annular, having the opening at its center for receiving the suture.

4. A device as in claim 1, having a pair of circumferentially spaced-apart apertures on the surface or at a proximal end for receiving free suture ends.

5. A device as in claim 1, wherein the shaft has a length in the range from 7 cm to 12 cm.

6. A device as in claim 1, wherein at least the distal end of the shaft is composed of a soft material.

7. A blood vessel puncture occlusion device for applying pressure directly to the adventitial surface of a blood vessel, said puncture being disposed within a tissue tract, said device comprising:

a removable rigid shaft having a proximal end, a distal end, and a surface at its distal end, the surface having a size and shape suitable for engaging and applying hemostasis inducing pressure distally against an adventitial surface of the blood vessel, wherein the surface defines au opening for receiving a suture or a guidewire, has au area in the range from 6 mm² to 30 mm², and is oriented distally at an angle from 30°

to 60°

relative to the axis of the shaft, and wherein the shaft has a length between the proximal and distal ends sufficient for manually grasping the shaft from proximally of the tissue tract while the surface engages the blood vessel so as to remove the shaft proximally from the tissue tract; and

pressure maintaining means for holding the distal surface against the adventitial surface of the blood vessel, the pressure maintaining means disposed near the proximal end of the shaft and affixing the suture or guidewire near the proximal end of the shaft after movement of the suture or guidewire relative to the shaft so that pressure is transferred along the shaft and the suture or guidewire.

8. A system for occluding a puncture of a blood vessel, the blood vessel having an adventitial surface, said system comprising:

a removable shaft having a proximal end, a distal end, and a surface at the distal end with an opening, the surface adapted for applying pressure directly to the adventitial surface of the blood vessel, the surface engaged against the adventitial surface about the puncture;

an anchor disposed near the proximal end of the removable shaft; and

a guidewire extending proximally from the puncture and through the opening, the guidewire releasably secured to the anchor so that the guidewire holds the surface of the shaft against the adventitial surface of the blood vessel.

9. The system of claim 8, wherein the guidewire is in tension between the puncture and the proximal end of the shaft so as to transmit a force in the range from 5 g to 50 g to the surface, the surface having an area in the range from about 6 mm² to 30 mm².

10. The system of claim 8, wherein the surface is flat and annular.

11. The system of claim 8, wherein the surface is elliptical and convex, having a center raised in the range from 0.1 mm to 1.0 mm relative to an edge.

12. A system for occluding a puncture of a blood vessel, the system comprising:

a removable shaft having a proximal end, a distal end, and a surface at its distal end, the surae having a size and shape suitable for applying sufficient pressure to the adventitial surface of the blood vessel over the puncture to substantially inhibit blood flow through the puncture;

means for applying pressure to the adventitial surface of the blood vessel, the pressure applying means comprising a tensionable member selected from the group consisting of a suture and a guidewire, wherein tensionable member extends from the blood vessel along the shaft to the proximal end; and

means for anchoring the distal surface against the adventitial surface, the anchoring means disposed near the proximal end of the shaft receiving the tensionable member variably along a length of the tensionable member and affixing the received tensionable member near the proximal end of the shaft so that pressure is transferred along the shaft and the tensionable member to the adventitial surface from outside the tissue tract.

13. The system of claim 12, wherein the surface defines an opening through which a suture extends, the suture forming a suture loop that passes through the adventitial surface to attach the suture loop to the blood vessel, wherein the suture is free of attachment to a fastener within a lumen of the blood vessel.

14. The system of claim 13, wherein the surface contacts the adventitial surface surrounding the suture loop, and wherein the shaft and the surface form an angle which is substantially equal to an angle of the tissue tract relative to the adventitial surface so that the surface lies substantially flat over the adventitial surface while pressure is being applied.

15. The system of claim 12, wherein a force in the range from 5 g to 50 g is applied over an area in the range from about 6 mm² to 30 mm² for a time in the range from about 10 minutes to 24 hours.

16. The system of claim 12, wherein the surface comprises a convex surface having a center raised in the range from 0.1 mm to 1 mm relative to an edge.

17. A system for applying pressure directly to a puncture of a blood vessel having an adventitial surface, the system comprising:

a shaft having a proximal end, a distal end, and a surface at the distal end of the shaft which is oriented at an angle from 30°

to 60°

relative to the axis of the shaft, the surface having an aperture which receives the suture knot so that the suture knot slides along the shaft;

a suture having a knot and two free ends, the puncture being ligated with the suture; and

an anchor near the proximal end of the shaft which affixes the free ends of the suture to the proximal end of the shaft so that the tensioned suture urges the surface of the shaft against the adventitial surface, the anchor comprising an open channel laterally receiving the suture.

18. The system of claim 17 ether comprising a channel disposed along an outer surface of the shaft, the channel extending from the distal end toward the proximal end, wherein the channel directs the free ends of the suture toward the proximal end of the shaft.

19. The system of claim 17 wherein the distal end comprises an opening which connects the aperture to the channel, wherein the opening is adapted to receive the free ends of the suture to direct the free ends of the suture to the channel.

20. The system of claim 17 comprising a pair of slots disposed on opposite sides of the surface to direct the free ends toward the channel.

21. The system of claim 17 wherein the anchor is an O-ring.

22. The system of claim 17 wherein the proximal end comprises a second surface which is oriented at an angle from 30°

to 60°

relative to the axis of the shaft, the surface having a pair of slots disposed on opposite sides of the second surface which are adapted to receive the free ends of the suture to facilitate the advancement of a knot.

23. A system for applying pressure directly to a puncture of a blood vessel having an adventitial surface, the system comprising:

a shaft having a proximal end, a distal end, and a surface at the distal end of the shaft which is oriented at an angle from 30°

to 60°

relative to the axis of the shaft;

a knotted suture having two free ends relative to the shaft, the suture for ligating the puncture;

a pair of slots disposed on opposite sides of the surface, the slots facilitate the tightening of the suture knot and direct the free ends of the suture toward the proximal end of the shaft; and

means for anchoring the free ends of the suture to the proximal end of the shaft after the suture has been knotted, wherein the anchoring means tension the suture to urge the surface of the shaft against the adventitial surface.

24. The system of claim 23 wherein the system comprises a channel extending from the proximal end toward the distal end to direct the free ends of the suture toward the anchoring means.