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 a steep and controlled access path into a vascular lumen is disclosed. Methods for using the device are also disclosed.
1. A method for forming a self-sealing arteriotomy using a device comprising first and second introducers, the method comprising:
a. advancing the first introducer, the first introducer having a distal portion coupled to an anchor, through a first arteriotomy that has a first angle with respect for the vessel wall to place the anchor into a lumen of the artery;
b. applying a force to the first introducer to position an adjacent portion of the artery wall in a desired contact configuration relative to the anchor;
c. while maintaining the lumen portion in the desired contact configuration with the anchor, advancing the second introducer through a portion of the first introducer and through the artery wall to form a tract within the artery wall that has a substantially lateral portion, as well as a distal portion that defines a second angle with respect to the vessel wall and wherein the first angle is larger than the second angle, and wherein the tract is defined between overlapping tissue portions of the artery wall;
d. advancing the second introducer into the lumen of the artery; and
e. expanding the tract with a sheath so that a procedure may be performed therethrough, wherein after the procedure has been performed and the device and sheath have been withdrawn from the tract, blood pressure acting on the artery causes the overlapping tissue portions to collapse and self-seal.
2. The method of claim 1 , wherein the tract includes at least one sloped region.
3. The method of claim 1 , wherein the second introducer has a preformed bend.
4. The method of claim 1 , wherein the second introducer comprises a needle.
5. The method of claim 4 , wherein the needle is hollow.
6. The method of claim 1 , further comprising rotating the second introducer toward the lumen of the artery.
7. The method of claim 1 , wherein expanding the tract with the sheath comprises further comprising inserting the an introducer sheath over the second introducer.
8. The method of claim 1 , wherein the tract has a diameter of about 1.0 mm to about 10.2 mm.
9. The method of claim 1 , wherein the first angle and the second angle define an introduction angle relative to each other.
10. The method of claim 9 , wherein when the second introducer enters the lumen, the introduction angle is less than or equal to about 19°.
11. The method of claim 9 , wherein when the second introducer enters the lumen, the introduction angle is less than or equal to about 15°.
12. The method of claim 9 , wherein when the second introducer enters the lumen, the introduction angle is from about 5° to about 10°.
13. The method of claim 1 , wherein the force is a proximal force configured to urge the anchor into contact against the vessel wall.
14. The method of claim 13 , wherein desired contact configuration comprises one in which a portion of the anchor is aligned to be substantially parallel with a wall surface of the lumen of the artery.