Sheath-mounted arterial plug delivery device

• US 20040158287A1
• Filed: 01/09/2004
• Published: 08/12/2004
• Est. Priority Date: 07/14/2000
• Status: Active Grant

• Current Assignee: Allen Family Trust, Andrew H. Cragg, Boston Scientific Scimed (Boston Scientific Corporation), Bruce Feuchter, FirstMark II LP (FirstMark Capital, LLC), Geoffrey O. Hartzler, George Wallace, Pacific Venture Group II, L.P., PVG Associates II, L.P., Kingsbury Capital Partners, L.P. III (Timothy J. Wollaeger, MBA), Kingsbury Capital Partners, L.P. IV (Timothy J. Wollaeger, MBA)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Ashby, Mark, Cragg, Andrew H.
• Granted Patent: US 7,621,936 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• 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 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2090/062 penetration depth

Abstract

A method of facilitating hemostasis of a blood vessel puncture. The method includes the steps of inserting a tubular device into a puncture in a blood vessel to establish access to the blood vessel, providing a vessel closure system around the tubular device, introducing a hemostatic material into a space between the tubular device and vessel closure system, and delivering the hemostatic material adjacent to the puncture to facilitate hemostasis of the puncture.

Claims

1. A method of facilitating hemostasis of a blood vessel puncture, the method comprising:

inserting a tubular device into a puncture in a blood vessel to establish access to the blood vessel;

providing a vessel closure system around the tubular device;

introducing a hemostasis promoting material into a space between the tubular device and vessel closure system; and

delivering the hemostatic material adjacent to the puncture to facilitate hemostasis of the puncture.

2. The method of claim 1, further comprising a step of withdrawing the tubular device prior to delivery of the hemostatic material.

3. The method of claim 1, further comprising a step of hydrating an absorbable sponge material in a staging chamber portion of the vessel closure system.

4. The method of claim 3, further comprising a step of advancing the absorbable sponge material into a delivery position.

5. The method of claim 1, further comprising a step of locating the puncture by using a bleed-back hole in the vessel closure system.

6. The method of claim 1, further comprising a step of the locating the puncture by using tactile feedback.

7. The method of claim 1, further comprising a step of hydrating the hemostatic material with a syringe.

8. The method of claim 1, further comprising a step of positioning the hemostatic material within the system using a distal stop or vent.

9. The method of claim 1, further comprising a step of placing the tubular device and vessel closure system over a guidewire.

10. The method of claim 1, further comprising a step of facilitating bleed-back by providing a dilator within the tubular device.

11. The method of claim 1, further comprising a step of removing a proximal stop from the vessel closure system.

12. The method of claim 1, further comprising a step of advancing the hemostatic material with a pusher and delivering the hemostatic material by moving the vessel closure system proximally with respect to the pusher.

13. The method of claim 12, further comprising a step of holding the pusher stationary while the vessel closure system is withdrawn.

14. The method of claim 12, further comprising a step of advancing the pusher while the vessel closure system is held stationary.

15. The method of claim 9, further comprising a step of removing the guidewire after the hemostatic material is delivered.

16. The method of claim 1, further comprising a step of removing the vessel closure system after the hemostatic material is delivered.

17. The method of claim 11, further comprising a step of removing the tubular device while the vessel closure system and proximal stop remain stationary.

18. The method of claim 1, further comprising a step of advancing a pusher into the proximal stop and moving the vessel closure system proximally with respect to the pusher and the proximal stop.

19. The method of claim 1, further comprising a step of withdrawing the vessel closure device while holding the pusher and proximal stop stationary.

20. The method of claim 1, further comprising a step of withdrawing the vessel closure system and moving the vessel closure system proximal with respect to the proximal stop.

21. The method of claim 1, further comprising a step of placing the hemostatic material within the vessel closure system and then passing the tubular device through the vessel closure system.

22. The method of claim 1, further comprising a step of placing a hydrated sponge within the vessel closure system and withdrawing the tubular device prior to delivery of the hydrated sponge.

23. The method of claim 21, further comprising a step of advancing a stylet or obturator into the tubular device.

24. A method of facilitating hemostasis of a blood vessel puncture, the method comprising:

inserting a procedural access sheath through a tissue tract and into a puncture in a blood vessel;

providing a vessel closure system around the access sheath and at least partially in the tissue tract; and

performing a vascular procedure with the vessel closure system in the tissue tract.

25. A system for facilitating hemostasis of a blood vessel puncture, the system comprising:

a delivery cannula configured to be received around an access sheath;

a hemostatic promoting material within the delivery cannula for facilitating hemostasis of a blood vessel puncture when delivered adjacent to the puncture;

a proximal stop for preventing proximal motion of the hemostatic promoting material within the delivery cannula when the access sheath is withdrawn proximally from the delivery cannula; and

a pusher for delivering the sponge material from the delivery cannula.

26. The system of claim 25, wherein the delivery cannula is received coaxially around the access sheath.

27. The system of claim 25, wherein the delivery cannula is received asymmetrically around the access sheath.

28. The system of claim 25, wherein the hemostatic promoting material is an absorbable sponge.

29. The system of claim 25, wherein the hemostatic promoting material is a hydrated and compressed sponge.

30. The system of claim 25, wherein the delivery cannula has a staging chamber.

31. The system of claim 25, further comprising a distal stop or vent.

32. The system of claim 31, wherein the distal stop or vent is soluable.

33. The system of claim 31, wherein the distal stop or vent is absorbable.

34. The system of claim 31, wherein the distal stop or vent is removable.

35. The system of claim 25, wherein the access sheath has a bleed-back hole.

36. The system of claim 25, further comprising a dilator.

37. The system of claim 36, wherein the dilator fits over a guidewire.

38. The system of claim 25, further comprising an introduction port.

39. The system of claim 25, further comprising a stop cock.

40. The system of claim 25, wherein the delivery cannula has detent features.

41. The system of claim 40, wherein the detent is at least one bump.

42. The system of claim 40, wherein the detent is at least one ratchet.

43. The system of claim 40, wherein the detent is on an inside of the delivery cannula.

44. The system of claim 40, wherein the detent is on an outside diameter of the vessel closure system.

45. The system of claim 25, wherein the proximal stop has a proximal flange to facilitate proper placement within the delivery cannula.

46. The system of claim 25, wherein the hydration of the hemostatic material is performed with a syringe.