ACCESS AND CLOSURE DEVICE AND METHOD
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.