Apparatus and methods for sealing a vascular puncture

#The present invention relates generally to apparatus and methods for sealing punctures in a body, and more particularly, to apparatus and methods for sealing a vascular puncture extending through tissue into a blood vessel, and to apparatus and methods for delivering a plug into a percutaneous puncture extending from a patient's skin to a blood vessel or other body lumen to seal the puncture.

#Apparatus and methods are known for accessing a patient's vasculature percutaneously, e.g., to perform a procedure within the vasculature, and for sealing the puncture that results after completing the procedure. For example, a hollow needle may be inserted through a patient's skin and overlying tissue into a blood vessel. A guide wire may be passed through the needle lumen into the blood vessel, whereupon the needle may be removed. An introducer sheath may then be advanced over the guide wire into the vessel, e.g., in conjunction with or subsequent to one or more dilators.

#A catheter or other device may be advanced through the introducer sheath and over the guide wire into a position for performing a medical procedure. Thus, the introducer sheath may facilitate accessing and/or introducing various devices into the vessel, while minimizing trauma to the vessel wall and/or minimizing blood loss. Upon completing the procedure, the device(s) and introducer sheath may be removed, leaving a puncture extending between the skin and the vessel wall.

#FIG. 1 is an exploded side view of an apparatus for delivering a plug into a puncture through tissue.

#FIGS. 2A and 2B are cross-sectional views of the apparatus of FIG. 1, with a cartridge carrying a plug and anchor in proximal and distal positions, respectively.

#FIG. 3A is a perspective view of an exemplary embodiment of a plug that may be delivered using the apparatus of FIG. 1.

#Turning to the drawings, FIGS. 1, 2A, and 2B show an exemplary embodiment of an apparatus 101 for sealing a puncture through tissue. Generally, the apparatus 101 includes a cartridge or other tubular member 120 and a plunger, cincher, or other pusher member 130. The cartridge 120 generally carries a plug 2 and an anchoring element 102, such as those described further below. In addition, the apparatus 101 may include a positioning member 140, a delivery, access, or introducer sheath 20, and/or other components, e.g., a needle and/or guidewire for creating a puncture (not shown), and/or a source of sealing compound (also not shown).

#The introducer sheath 20 may be a substantially rigid, semi-rigid, and/or flexible tubular body, including a proximal end 22, a distal end 24 sized for insertion into a puncture through tissue, and a lumen 26 extending between the proximal and distal ends 22, 24. The distal end 24 may be tapered and/or may include a substantially atraumatic distal tip 25 for facilitating advancement through a puncture. The introducer sheath 20 may include a handle or hub 23 on the proximal end 22, and/or one or more seals on the proximal end 22, e.g., a hemostatic seal (not shown) that prevents proximal flow of blood or other fluids, yet accommodates inserting one or more instruments (also not shown) into the lumen 26 of the introducer sheath 20.

#The cartridge 120 may be an elongate tubular body including a proximal end 122, a distal end 124, and a lumen 126 extending between the proximal and distal ends 122, 124. The cartridge 120 may include a tapered distal tip 125 and/or an enlarged handle or hub 123 on the proximal end 122. The cartridge 120 may be substantially rigid, semi-rigid, or flexible, e.g., such that the cartridge 120 may be advanced through the introducer sheath 20 or otherwise into a puncture through tissue.