Claims
- 1. A device for facilitating hemostasis of a puncture in the wall of a blood vessel, the device comprising:
an introducer for compressing a sponge pledget for delivery into a patient to seal the puncture, the introducer including a staging chamber with a first diameter configured to receive the sponge pledget, a delivery chamber with a second diameter smaller than the first diameter, and a tapered section between the staging chamber and the delivery chamber for compressing the pledget; and a pusher insertable into the introducer for ejection of the pledget from the delivery chamber into a patient to seal the puncture in the blood vessel wall.
- 2. The device according to claim 1, wherein the introducer is a two part system including separate staging and delivery chambers, and wherein a distal end of the staging chamber is connectable to a proximal end of the delivery chamber.
- 3. The device according to claim 2, wherein the staging chamber and the delivery chamber are connectable by a luer fitting.
- 4. The device according to claim 3, wherein the staging chamber has a length shorter than a length of the delivery chamber.
- 5. The device according to claim 1, further comprising a template for cutting a piece of a sponge sheet for formation of the pledget.
- 6. The device according to claim 2, further comprising a template attached to the staging chamber for cutting a piece of a sponge sheet for formation of the pledget.
- 7. The device according to claim 1, further comprising a depth indicating member positioned on an exterior of the introducer and movable longitudinally with respect to the introducer.
- 8. The device according to claim 1, further comprising a vent cap configured to be received on a distal end of the introducer for axially locating the pledget with respect to the introducer, the vent cap having a vent hole sized to allow fluid to pass through the vent hole without allowing the pledget to pass through the vent hole.
- 9. The device according to claim 8, wherein the vent cap includes a dome shaped interior for positioning the pledget distally of the distal end of the introducer.
- 10. The device according to claim 2, further comprising vent cap configured to be received on a distal end of the staging chamber for use during hydration of the pledget within the staging chamber, the vent cap having a vent hole sized to allow fluid to pass through the vent hole without allowing the pledget to pass through the vent hole.
- 11. The device according to claim 10, wherein the vent cap includes a vent finger configured to extend into the distal end of the staging chamber to block passage of the pledget to the distal end of the staging chamber.
- 12. The device according to claim 1, wherein the pusher includes a lumen for insertion of a guidewire and a distal end of the pusher lumen has a funnel shape.
- 13. The device according to claim 1, wherein the pusher includes a proximal stop for limiting proximal motion of the pusher.
- 14. The device according to claim 13, wherein the pusher includes a sliding fitting for connection to a proximal end of the introducer and the proximal stop limits proximal motion of the pusher once the fitting has been connected to the proximal end of the introducer.
- 15. The device according to claim 14, wherein the plunger includes a fixed luer fitting at a proximal end which is connectable to the sliding fitting after the pledget has been delivered allowing the introducer and plunger to be used together to apply local compression to the delivered pledget.
- 16. The device according to claim 13, wherein the proximal stop is adjustable.
- 17. The device according to claim 16, wherein the proximal stop includes ratchet teeth and a ratchet tab.
- 18. The device according to claims 13, wherein the proximal stop includes a detent and corresponding members.
- 19. A method for facilitating hemostasis of a puncture in the wall of a blood vessel, the method comprising:
establishing a depth of a blood vessel puncture of a patient; loading an introducer with a sponge pledget by hydrating and compressing the pledget; loading the introducer over a guidewire positioned in the blood vessel by inserting the guidewire through the hydrated and compressed pledget; and ejecting at least a portion of the pledget adjacent the blood vessel puncture to facilitate hemostasis.
- 20. The method for facilitating hemostasis of a puncture in the wall of a blood vessel according to claim 19, wherein the step of establishing a depth of a blood vessel is performed by introducing the introducer into a tissue tract until a distal end of the introducer abuts an exterior of the blood vessel wall and marking the depth of the blood vessel with a depth indicator on the introducer.
- 21. The method for facilitating hemostasis of a puncture in the wall of a blood vessel according to claim 19, wherein the pledget is hydrated in a staging chamber of the introducer, and the staging chamber of the introducer is connected to a delivery chamber of the introducer for delivery of the pledget to the delivery chamber.
- 22. The method for facilitating hemostasis of a puncture in the wall of a blood vessel according to claim 19, wherein the introducer is advanced over the guidewire to an exterior of the blood vessel through a sheath.
- 23. The method for facilitating hemostasis of a puncture in the wall of a blood vessel according to claim 22, wherein the step of establishing a depth of the blood vessel puncture is performed by inserting the sheath with a removable dilator inside the sheath.
- 24. A device for facilitating hemostasis of a puncture in the wall of a blood vessel, the device comprising:
a staging chamber for hydrating a sponge pledget in preparation for delivery of the pledget into a patient to seal the puncture, a distal end of the staging chamber having a tapered lumen; a delivery chamber for delivering the hydrated sponge pledget to the puncture, a proximal end of the delivery chamber connectable to the distal end of the staging chamber for delivery of the pledget from the staging chamber to the delivery chamber; and a pusher insertable into the delivery chamber for ejection of the pledget from the delivery chamber into a patient to seal the puncture in the blood vessel wall.
- 25. The device of claim 24, wherein the staging chamber has a lumen with a first diameter and the delivery chamber has a lumen with a second diameter which is smaller than the first diameter.
- 26. The device of claim 24, further comprising a first vent cap configured to be connected to a distal end of the staging chamber and a second vent cap configured to be connected to a distal end of the delivery chamber.
- 27. A device for facilitating hemostasis comprising:
an elongated member of absorbable sponge configured to facilitate hemostasis of a blood vessel puncture when positioned adjacent an exterior of the puncture; and a tip extending from the sponge and configured to extend into the blood vessel through the blood vessel puncture to locate the sponge.
- 28. The device according to claim 27, wherein the tip is a dissolvable tip.
- 29. The device according to claim 28, wherein the dissolvable tip dissolves within 72 hours of placement in the blood vessel.
- 30. The device according to claim 27, wherein the tip is connected to a removable member, and wherein when the elongated member is positioned adjacent the puncture the removable member extends to a skin surface to allow removal of the tip after a predetermined period of time.
- 31. The device according to claim 27, wherein the elongated member is a substantially cylindrical member having a first diameter and the tip has a second diameter which is less than one half the first diameter.
- 32. The device according to claim 27, wherein the elongated member is wrapped around at least a portion of the material which forms the tip.
- 33. The device according to claim 27, wherein the tip is solid.
- 34. The device according to claim 27, wherein the tip is hollow to allow passage of a guidewire through the tip.
- 35. A method of super hydrating an absorbable sponge material for delivery to a body for facilitating hemostasis, the method comprising:
placing a dry piece of absorbable sponge in a delivery device; and subjecting the absorbable sponge to a high pressure fluid to rapidly and completely hydrate the absorbable sponge.
- 36. The method according to claim 35, wherein the fluid is at about 5 psi or greater.
- 37. The method according to claim 36, wherein the fluid is injected into the delivery device.
- 38. The method according to claims 36, wherein the delivery device is placed in a pressurized container of fluid.
- 39. A method for facilitating hemostasis of a puncture in the wall of a blood vessel, the method comprising:
positioning a sheath into a blood vessel puncture of a patient; loading a sponge pledget into the sheath until a distal end of the pledget is positioned at a location corresponding to an outside wall of the blood vessel puncture; and withdrawing the sheath to deposit the pledget adjacent the blood vessel puncture to facilitate hemostasis.
- 40. The method according to claim 39, wherein the pledget is inserted directly into the sheath and is held in place by a plunger.
- 41. The method according to claim 39, wherein the pledget is loaded into the sheath by inserting an introducer containing the pledget into the sheath.
- 42. The method according to claim 39, wherein the positioning of the sheath is confirmed by imaging a marker on the sheath.
Parent Case Info
[0001] This application is a continuation-in-part of U.S. Ser. No. 09/071,284 filed May 1, 1998, which is incorporated herein by reference in its entirety.
Continuations (1)
|
Number |
Date |
Country |
Parent |
09022784 |
Feb 1998 |
US |
Child |
10319260 |
Dec 2002 |
US |