Vascular access closure system
View Patent ↗A sealing device for sealing punctures in blood vessel walls including a flange connected to a flexible stem having an expansion portion in it. The flexible stem is adapted to be accommodated inside a delivery tube. The delivery tube further includes a hand-hold for ease of handling. The sealing device may further include a loader and a cutter. The flange and flexible stem are preferably constructed of a biodegradable material that has a tensile strength, rigidity, memory and other physical qualities similar to medical grade silicone. The resilient transverse expansion portion expands when deployed beyond the delivery tube in the tissue tract to create a frictional interface with the interior surface of the tissue tract to resist displacement of the flexible stem from a desired location in the tissue tract. The flexible stem also includes a flange at the distal end of the flexible stem to seal the puncture when the flexible stem is deployed.
1. A method for percutaneously sealing a puncture in a blood vessel wall, the puncture being at the termination of a tissue tract that passes through intervening tissues between the vessel wall puncture and a corresponding puncture through the skin, the method comprising:
inserting a flexible stem into a delivery tube;
in the process of inserting the flexible stem into the delivery tube, tensioning the flexible stem so that the flexible stem alters from a transversely expanded state to a generally linear state within the delivery tube;
inserting the delivery tube including the joined flexible stem into an introducer already placed in the tissue tract, the flexible stem having a flange at a distal end thereof;
pushing the delivery tube through the introducer until the distal end of the flexible stem is within a lumen of the blood vessel;
withdrawing the delivery tube from the introducer;
withdrawing the flexible stem until the flange is flush against the blood vessel wall;
withdrawing the introducer from the tissue tract; and
maintaining tension on a portion of the flexible stem by contact between part of the flexible stem and the tissue tract as the flexible stem returns to a transversely expanded state and wherein the flexible stem terminates beneath the skin when the method is completed.
2. The method as claimed in claim 1 , further comprising severing the flexible stem at a desired location.
3. The method as claimed in claim 1 , further comprising advancing a cutter over the flexible stem to sever the flexible stem.
4. The method as claimed in claim 1 , further comprising engaging a loader to the introducer to facilitate the insertion of the delivery tube and the flexible stem into the introducer.
5. The method as claimed in claim 1 , further comprising asymmetrically folding the flange while inserting it into the introducer.
6. The method as claimed in claim 1 , further comprising utilizing a flexible stem made from a biodegradable material.