Device and method for sealing blood vessels
The present invention provides devices, systems, and methods for percutaneously sealing a puncture site in tissue tracts and vessels in human or animal bodies. One system includes a locating assembly that is used to locate the puncture site and can also provide temporary hemostasis when the system is used for closing a vessel puncture. The system also includes a compression assembly comprising a tubular member with a balloon on a distal end thereof. This balloon is at a fixed distance from the locator tip which locates the balloon outside the vessel wall at a predetermined distance. Inflation of this balloon causes forward elongation of the balloon which compresses subcutaneous tissue between the distal tip of the balloon and the vessel wall. This tissue compression against the puncture site is the mechanism that provides hemostasis.
1. A method for hemostasis of a puncture site in a wall of a blood vessel at an end of a tissue tract having a sheath therein, the method comprising:
providing a locating member having a proximal end, a distal end, and an expansible member disposed on the distal end thereof,
inserting the locating member through the sheath in the tissue tract so that the expansible member on the locating member enters a lumen of the blood vessel;
expanding the expansible member on the inserted locating member and drawing the inserted locating member proximally so that the expanded expansible member covers the puncture site in the vessel wall;
removing the sheath from the tissue tract while the inserted locating member remains in place;
providing a tubular compression member having a proximal end, a distal end, a central passage between said proximal end and said distal end, and an expansible tissue compression element disposed over the distal portion thereof, and
advancing the tubular compression member over the inserted locating member after the sheath has been removed from the tissue tract so that the locating member is received in the central passage of the tubular compression member and a distal end of the expansible tissue compression element is located within the tissue tract at a predetermined distance proximal from the wall of the blood vessel to define a tissue compression region; and
expanding the expansible tissue compression element within the tissue tract above the blood vessel wall to apply pressure against subcutaneous tissue and to compress said tissue over the puncture site in the blood vessel wall to promote hemostasis, wherein the compression element is not in direct contact with the vessel wall, and wherein the expansible tissue compression element on the compression member is left in place until hemostasis has been achieved.
2. The method of claim 1 , wherein the predetermined distance is in a range from about 0.05 inch to about 0.5 inch.
3. The method of claim 2 , wherein the predetermined distance is in a range from about 0.2 inch to about 0.3 inch.
4. The method of claim 1 , wherein the expansible tissue compression element on the compression member comprises a balloon.
5. The method of claim 4 , wherein expanding comprises inflating a superior aspect of the balloon greater than an inferior aspect of the balloon.
6. The method of claim 4 , wherein expanding comprises inflating a distal face of the balloon at an angle to the compression member similar to an angle formed between the compression member and the blood vessel.
7. The method of claim 4 , wherein expanding comprises inflating the balloon to a deployed configuration comprising a conical shape.
8. The method of claim 4 , wherein expanding comprises unfolding concentric folds of the balloon.
9. The method of claim 4 , wherein expanding comprises inflating the balloon to a deployed configuration having a concave distal end.
10. The method of claim 1 , wherein the expansible member on the locating member is expanded to an expanded configuration within the blood vessel having a diameter in a range from about 0.05 inch to about 0.5 inch.
11. The method of claim 1 , further comprising contracting and withdrawing the locating member while the compression member remains in place.
12. The method of claim 1 , further comprising imaging the expansible element during positioning.
13. The method of claim 1 , further comprising delivering radio frequency energy, ultrasound energy, or microwave energy to the puncture site.
14. The method of claim 1 , further comprising delivering a clot promoting agent or anti-infection agent to the puncture site.