Access and closure device and method

Abstract

Devices and methods for accessing and closing vascular sites are disclosed. Self-sealing closure devices and methods are disclosed. A device that can make both steeply sloping and flat access paths into a vascular lumen is disclosed. The device can also form arteriotomies with sections cleaved between a vessel's intima and adventitia. Methods for using the device are also disclosed.

1 - 25 . (canceled) 
   
   
       26 . A device for forming a tract through tissue comprising:
 a delivery guide;   an anchor coupled to the delivery guide and extending distally therefrom, the anchor comprising first, second, and third elongated portions, a first curved portion between the first and second elongated portions, and a second curved portion between the second and third elongated portions; and   an introduction device slidably housed within the delivery guide and deployable from the delivery guide through an opening in the delivery guide.   
   
   
       27 . The device of  claim 26 , wherein the anchor is fixedly coupled to the delivery guide. 
   
   
       28 . The device of  claim 27 , further comprising a retainer deployable from the anchor. 
   
   
       29 . The device of  claim 28 , wherein the introduction device comprises a needle. 
   
   
       30 . The device of  claim 29 , wherein the needle is hollow. 
   
   
       31 . The device of  claim 26 , wherein the anchor is integral with the delivery guide. 
   
   
       32 . The device of  claim 26 , wherein the first curved portion has a radius of curvature of about 0.1 millimeter to about 2.0 millimeters. 
   
   
       33 . The device of  claim 32 , wherein the second curved portion has a radius of curvature of about 0.1 millimeter to about 2.0 millimeters. 
   
   
       34 . The device of  claim 26 , wherein the first and second elongated portions have an anchoring angle therebetween of about 90° to about 160°. 
   
   
       35 . The device of  claim 34 , wherein the anchoring angle is from about 120° to about 150°. 
   
   
       36 . The device of  claim 35 , wherein the anchoring angle is about 135°. 
   
   
       37 . The device of  claim 34 , wherein the second and third elongated portions have an anchoring angle therebetween of about 900 to about 160°. 
   
   
       38 . The device of  claim 37 , wherein the anchoring angle is from about 1200 to about 150°. 
   
   
       39 . The device of  claim 38 , wherein the anchoring angle is about 1350. 
   
   
       40 . The device of  claim 26 , wherein the anchor has a cross-sectional diameter of about 0.38 millimeter to about 1.0 millimeter. 
   
   
       41 . The device of  claim 26 , wherein the anchor is flexible. 
   
   
       42 . The device of  claim 26 , wherein the anchor further comprises a guide eye sheath. 
   
   
       43 . The device of  claim 26 , wherein the anchor further comprises an attachable guidewire. 
   
   
       44 . The device of  claim 26 , wherein the introduction device comprises a needle. 
   
   
       45 . The device of  claim 44 , wherein the needle is hollow. 
   
   
       46 . The device of  claim 26 , wherein the opening in the delivery guide is located proximal to a distal end of the anchor. 
   
   
       47 . The device of  claim 26 , further comprising a delivery guide extension that is integral with the delivery guide. 
   
   
       48 . The device of  claim 47 , wherein the delivery guide extension is flexible. 
   
   
       49 . The device of  claim 26 , further comprising a retainer deployable from the anchor. 
   
   
       50 . A method for forming a tract in a tissue wall having an interior surface and an exterior surface, the method comprising:
 advancing an anchor through the tissue wall, the anchor comprising first, second, and third elongated portions, a first curved portion between the first and second elongated portions, and a second curved portion between the second and third elongated portions;   contacting the anchor with the interior surface of the tissue wall; and   advancing an introduction device into the tissue wall while the anchor is in contact with the interior surface of the tissue wall, to form a tract in the tissue wall.   
   
   
       51 . The method of  claim 50 , wherein the tissue comprises a vessel and the method comprises advancing the anchor into a lumen of the vessel. 
   
   
       52 . The method of  claim 51 , wherein the vessel comprises an artery. 
   
   
       53 . The method of  claim 50 , wherein the anchor has an anchor longitudinal axis and the introduction device has an introduction longitudinal axis that forms an introduction angle with the anchor longitudinal axis. 
   
   
       54 . The method of  claim 53 , further comprising advancing the introduction device into a lumen defined by the tissue wall. 
   
   
       55 . The method of  claim 54 , wherein when the introduction device enters the lumen, the introduction angle is from about 0° to about 30°. 
   
   
       56 . The method of  claim 55 , wherein when the introduction device enters the lumen, the introduction angle is from about 0° to about 19°. 
   
   
       57 . The method of  claim 56 , wherein when the introduction device enters the lumen, the introduction angle is from about 0° to about 15°. 
   
   
       58 . The method of  claim 57 , wherein when the introduction device enters the lumen, the introduction angle is from about 5° to about 10°. 
   
   
       59 . The method of  claim 58 , wherein when the introduction device enters the lumen, the introduction angle is about 10°. 
   
   
       60 . The method of  claim 50 , wherein the tract is self-sealing. 
   
   
       61 . The method of  claim 50 , further comprising advancing a tool through the introduction device. 
   
   
       62 . The method of  claim 61 , wherein the tool comprises a guidewire. 
   
   
       63 . The method of  claim 62 , further comprising advancing an introducer sheath over the guidewire.