Percutaneous catheter directed intravascular occlusion devices
The present invention provides an improved vascular occlusion device having improved flexibility and retention of the type fabricated from braided tubular metal fabric having an expanded preset configuration and an elongated collapsed reduced diameter configuration for delivery through a catheter to a treatment site and shaped to create an occlusion of an abnormal opening in a body organ or vessel, the woven metal fabric having a memory property whereby the medical device tends to return to said expanded preset configuration when unconstrained. The device further including at least one disk portion adjacent a body cylindrical portion formed from the fabric and having a transition diameter between the disk and cylindrical portion, significantly smaller than the diameter of the disk and the diameter of the cylindrical portion.
1. A method of occluding a cavity of a patient with an occluder, the method comprising:
advancing a delivery catheter through vasculature of the patient until a distal end of the delivery catheter is positioned proximate to the cavity or within the cavity;
when the distal end of the delivery catheter is positioned proximate to the cavity or within the cavity, advancing a distal lobe of the occluder relative to the delivery catheter to allow the distal lobe to transition from a collapsed condition within the delivery catheter to an expanded condition outside of the delivery catheter;
positioning the distal lobe of the occluder within the cavity;
deploying a proximal flange of the occluder from the delivery catheter; and
positioning the proximal flange against tissue of a wall forming an opening that leads into the cavity, such that (i) the distal lobe is positioned within the cavity and a radially outer surface of the distal lobe frictionally engages tissue of a lumen wall that forms the cavity and which is positioned adjacent to the opening, (ii) the proximal flange is positioned outside the cavity, and (iii) a waist of the occluder extends through the opening and connects the distal lobe to the proximal flange, the waist having a diameter that is smaller than a diameter of the distal lobe and smaller than a diameter of the proximal flange,
wherein after the distal lobe transitions to the expanded condition and after the proximal flange is deployed, the distal lobe has a first length in a proximal-to-distal direction, the proximal flange has a second length in the proximal-to-distal direction, the first length being larger than the second length.
2. The method of claim 1 , wherein while the proximal flange contacts the tissue of the wall that forms the opening, the waist is at least partially surrounded by the distal lobe.
3. The method of claim 2 , wherein while the proximal flange contacts the tissue of the wall that forms the opening, the waist maintains tension between the distal lobe and the proximal flange.
4. The method of claim 1 , wherein the proximal flange of the occluder is deployed from the delivery catheter while the distal lobe is positioned within the cavity.
5. The method of claim 4 , wherein deploying the proximal flange of the occluder from the delivery catheter includes allowing the proximal flange to transition from a smaller diameter delivery configuration within the delivery catheter to a larger diameter deployed condition outside of the delivery catheter.
6. The method of claim 1 , wherein positioning the distal lobe of the occluder within the cavity includes engaging protrusions extending radially outwardly from the distal lobe into frictional engagement with tissue that defines the cavity.
7. The method of claim 6 , wherein the protrusions are hooks.
8. The method of claim 7 , wherein the hooks lack barbs.
9. The method of claim 8 , wherein the lack of barbs on the hooks is configured to allow for reversible engagement of the hooks with the tissue by moving the distal lobe in a direction opposite to open ends of the hooks.
10. The method of claim 9 , wherein when deployed, the open ends of the hooks are oriented toward the proximal flange.
11. The method of claim 1 , wherein when deployed, the proximal flange has a diameter between 6 mm and 35 mm.
12. The method of claim 1 , wherein when deployed, the distal lobe has a diameter between 2 mm and 28 mm.
13. The method of claim 1 , wherein the waist, when deployed, has a diameter between 1 mm and 8 mm.
14. The method of claim 1 , wherein the occluder is formed of a shape memory alloy.
15. The method of claim 14 , wherein the shape memory alloy is Nitinol.
16. The method of claim 1 , wherein while positioning the distal lobe of the occluder within the cavity, a shaft within the delivery catheter is reversibly coupled to a proximal hub of the proximal flange.
17. The method of claim 16 , further comprising rotating the shaft within the delivery catheter after the distal lobe of the occluder is positioned within the cavity.
18. The method of claim 1 , wherein an occlusion material is coupled to the distal lobe.
19. The method of claim 18 , wherein the occlusion material includes polyester fiber.
20. The method of claim 1 , wherein allowing the distal lobe to transition from the collapsed condition to the expanded condition includes allowing the distal lobe to self-expand.