Self-expanding hemostatic devices and methods for fascia and vessel passages
Self-expanding plug embodiments may be used in conjunction with vascular closure device embodiments to promote hemostasis at surgical sites or any other suitable location. In some cases, vascular closure device embodiments may include self-expanding plug embodiments in order to promote hemostasis at a surgical site during a vascular closure procedure.
1 . A method for vascular closure, comprising:
advancing an elongate shaft of an inner hemostatic assembly of a vascular closure device over a guidewire and through a passage in a tissue layer which is disposed adjacent an access hole in a wall of a patient's blood vessel until a distal end of the elongate shaft is disposed within the patient's vessel and a self-expanding plug disposed on a distal section of the elongate shaft is disposed within the access hole in an expanded state and is reducing leakage of blood from the access hole;
positioning a distal end of an outer housing of the vascular closure device adjacent the passage in the tissue layer;
deploying a plurality of anchor deployers from a distal section of the outer housing of the vascular closure device and engaging the tissue layer in positions disposed about the passage in the tissue layer with respective anchors of the plurality of anchor deployers;
securing the anchors to the tissue layer in the positions disposed about the passage in the tissue layer;
drawing the anchors closer together with filaments secured to each of the anchors so as to draw the anchors and respective portions of the tissue layer secured to each of the anchors together thereby reducing the passage in the tissue layer;
proximally withdrawing the inner hemostatic assembly from the patient's vessel and into the inner lumen of the outer housing until the elongate shaft is no longer disposed within the access hole of the vessel or passage of the tissue layer; and
deploying a tissue grip to secure the portions of the tissue layer which have been drawn together thereby closing the passage in the tissue layer and achieving vascular closure of the access hole in the blood vessel,
wherein the vascular closure device further comprises a lateral surface configured to extend radially from a distal section of the elongate shaft distal of the self-expanding plug and further comprising radially extending the lateral surface from the elongate shaft while the lateral surface is disposed within the blood vessel to provide a reference point between relative axial positions of the wall of the blood vessel and the self-expanding plug.
2 . The method of claim 1 wherein the inner hemostatic assembly is proximally retracted simultaneously with drawing the anchors closer together with the filaments.
3 . The method of claim 1 further comprising proximally retracting the guidewire from the access hole and passage.
4 . The method of claim 1 wherein the self-expanding plug is disposed within the inner lumen of the outer housing in a compressed state as the elongate shaft of the inner hemostatic assembly is being advanced and further comprising distally extending the self-expanding plug from the inner lumen and allowing the self-expanding plug to self-expand to the expanded state within the access hole.
5 . The method of claim 1 wherein the self-expanding plug is sealed against the access hole in the patient's blood vessel.
6 . The method of claim 1 wherein each of the plurality of anchors is deployed in a distal and radially outward direction from the distal section of the outer housing.
7 . The method of claim 1 wherein deploying the tissue grip comprises deploying a tissue adhesive onto the portions of the tissue layer that have been drawn together by the anchors.
8 . The method of claim 1 wherein applying a tissue adhesive to the portions of the tissue layer that have been drawn together by the anchors comprises applying cyanoacrylate adhesive to the portions of the tissue layer that have been drawn together by the anchors.
9 . The method of claim 1 wherein deploying the tissue grip comprises deploying a lock ring onto the filaments.
10 . The method of claim 9 wherein deploying the lock ring comprises sliding a self-contracting lock ring in an expanded state from a distal end of the housing over the filaments and allowing the self-contracting lock ring to contract to a relaxed state over the filaments.
11 . The method of claim 1 wherein the elongate shaft of the inner hemostatic assembly is advanced with the self-expanding plug in a constrained state until the self-expanding plug is disposed within the access hole and further comprising releasing the self-expanding plug from the constrained state into the expanded state by releasing a constraint sock disposed over the self-expanding plug from a constrained state to an unconstrained state thereby reducing leakage of blood from the access hole.
12 . The method of claim 11 wherein releasing the self-expanding plug from the constrained state comprises severing a thread which secures the constraint sock in the constrained state.
13 . The method of claim 1 wherein the lateral surface comprises a hinged foot with an inner end pivotally secured to the elongate shaft and radially extending the hinged foot comprises activating a foot actuator which is operatively coupled to the hinged foot.