Drug eluting vascular closure devices and methods
Drug eluting vascular closure devices and methods for closing a blood vessel puncture site disposed at a distal end of a tissue tract are described. The devices and methods rely on a combination of the body's own natural mechanism to achieve hemostasis with bio-chemical agents to accelerate the hemostatic process. One method includes the steps of introducing a closure device through the tissue tract and deploying an expansible member at a distal end of the device within the blood vessel to occlude the puncture site. A bio-chemical sealing member disposed proximal the expansible member is then displaced so as to expose a bio-chemical region or release region of the device. At least one bio-chemical agent is thereafter released from the device and into the tissue tract to accelerate the occlusion process in the tract.
1. A method for closing a blood vessel puncture site disposed at a distal end of a tissue tract, the method comprising:
introducing a closure device through the tissue tract, wherein a bio-chemical agent region of the closure device is coated with at least one bio-chemical agent prior to being introduced through the tissue tract;
deploying an expansible member at a distal end of the device within the blood vessel after the closure device, including the bio-chemical agent region, has been introduced through the tissue tract; and
displacing a bio-chemical region sealing member disposed proximal the expansible member so as to both expose the bio-chemical agent coated on the bio-chemical agent region of the device and apply tension to the expansible member through a tensioning element of the closure device to seat the expansible member against a puncture site; and
wherein the at least one bio-chemical agent hydrates into surrounding fluids to form a coagulum in the tissue tract,
wherein the tensioning element is disposed proximal the expansible member and is disposed coaxially over and surrounding an inner shaft of the closure device so that the expansible member is seated against a puncture site.
2. The method of claim 1 , wherein the sealing member is displaced a distance in a range from about 0.1 cm to about 10 cm.
3. The method of claim 1 , wherein deploying the tensioning element and displacing the sealing member is carried out simultaneously or sequentially.
4. The method of claim 1 , further comprising limiting elongation of the tensioning element.
5. The method of claim 1 , further comprising locating and closing the puncture site in the blood vessel wall with the expansible member.
6. The method of claim 5 , further comprising positioning the region at a predetermined distance proximal to the expansible member and blood vessel wall.
7. The method of claim 1 , wherein the bio-chemical agent comprises a clot promoting or vaso-constricting agent.
8. The method of claim 7 , wherein the bio-chemical agent is released for a time period in the range from about 0.1 minute to about 15 minutes.
9. The method of claim 1 , wherein the bio-chemical agent consists essentially of thrombin or fibrinogen.
10. The method of claim 1 , wherein the bio-chemical agent is released over a time from 0.1 minute to 15 minutes.
11. The method of claim 1 , further comprising withdrawing the closure device, including the bio-chemical agent region, from the tissue tract to leave in the tissue tract the at least one bio-chemical agent that has hydrated into surrounding fluids and coagulum generated from the at least one bio-chemical agent reconstituted with fluids in the tissue tract.
12. The method of claim 1 , wherein the inner shaft of the closure device comprises a distal end coupled to the expansible member.
13. The method of claim 1 , wherein the tensioning element comprises a coil spring.
14. The method of claim 1 , wherein the tensioning element is disposed under the sealing member and proximal the expansible member.
15. The method of claim 1 , wherein the tensioning element comprises a proximal end attached to a proximal end of the sealing member.
16. A method for closing a blood vessel puncture site disposed at a distal end of a tissue tract, the method comprising:
introducing a closure device through the tissue tract, wherein a bio-chemical agent region of the closure device is coated with at least one bio-chemical agent prior to being introduced through the tissue tract;
deploying an expansible member at a distal end of the device within the blood vessel after the closure device, including the bio-chemical agent region, has been introduced through the tissue tract; and
displacing a bio-chemical region sealing member disposed proximal the expansible member so as to both expose the bio-chemical agent coated on the bio-chemical agent region of the device and apply tension to the expansible member through a tensioning element of the closure device to seat the expansible member against a puncture site; and
wherein the at least one bio-chemical agent hydrates into surrounding fluids to form a coagulum in the tissue tract, and
wherein the tensioning element comprises a coil spring.