Vascular closure devices and methods providing hemostatic enhancement
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 chemical and/or biological 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 chemical and/or biological sealing member disposed proximal the expansible member is then displaced so as to expose a chemical and/or biological region or release region of the device. At least one chemical and/or biological 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 the closure device comprises an insoluble chemical and/or biological agent immobilized on a region of the closure device and a sealing member disposed over the region, wherein the insoluble chemical and/or biological agent, the region of the closure device the insoluble chemical and/or biological agent is immobilized on, and the sealing member are concurrently introduced through the tissue tract;
deploying an expansible member on a distal end of the closure device within the blood vessel, wherein the region of the closure device the insoluble chemical and/or biological agent is immobilized on is proximal of the expansible member;
deploying a coil spring disposed proximal the expansible member into the tissue tract;
tensioning the coil spring to apply a tension to the expansible member so that the expansible member is seated against the puncture site;
retracting the sealing member relative to the region of the closure device the insoluble chemical and/or biological agent is immobilized on to expose blood in the tissue tract to the insoluble chemical and/or biological agent, wherein said insoluble chemical and/or biological agent promotes hemostasis in the tissue tract and remains immobilized on the device after exposure to the blood; and
collapsing the expansible member and removing the closure device so that the region of the closure device the insoluble chemical and/or biological agent is immobilized on is removed from the tissue tract,
wherein the insoluble chemical and/or biological agent has a negative electrical charge which promotes coagulation.
2. A method as in claim 1 , wherein the insoluble chemical and/or biological agent is selected from the group consisting of kaolin and silica.
3. A method as in claim 1 , wherein the region of the closure device the insoluble chemical and/or biological agent is immobilized on extends from 0.1 cm to 10 cm proximally of the expansible member.
4. A method as in claim 1 , wherein deploying the coil spring and retracting the sealing member are carried out simultaneously or sequentially.
5. A method as in claim 1 , further comprising limiting elongation of the coil spring.
6. A method as in claim 1 , wherein the insoluble chemical and/or biological agent is exposed for a time period of at least about 0.1 minute.
7. A method as in claim 1 , further comprising allowing a predetermined amount of blood to come in contact with the insoluble chemical and/or biological agent for preconditioning prior to exposure to the tissue tract.
8. A method as in claim 7 , wherein the preconditioning lasts for a time from 0.1 to 15 minutes.
9. A method as in claim 7 , wherein the amount of blood to be preconditioned is determined by a gap between the sealing member and the insoluble chemical and/or biological agent.