Devices and methods for occlusion of vascular system abnormalities

A delivery system for deploying a medical device to a target site, the delivery system comprising:

• a medical device comprising:
• a proximal and a distal end, wherein the proximal end comprises a disc and the distal end comprises at least one lobe, wherein the disc and the lobe are connected by a connecting member, wherein the at least one lobe comprises a proximal portion, a distal portion and a middle portion, wherein the proximal portion transitions into the middle portion in curved transitions and the middle portion transitions into the distal portion in curved transitions, wherein the at least one lobe has an expanded configuration when deployed at the target site and a reduced configuration for delivery to the target site, and a plurality of stabilizing wires coupled to the at least one lobe at the middle portion, each stabilizing wire comprising an hook portion extending radially outward from the at least one lobe;
• and
• a delivery device comprising:
• a delivery catheter;
• a delivery cable within the delivery catheter and translatable with respect to the delivery catheter;
• and
• a coupling member configured to couple the medical device to the delivery cable for facilitating at least one deployment of the medical device at the target site.

A method for occluding a Left Atrial Appendage (LAA), the method comprising:

• providing a medical device comprising a proximal and a distal end, wherein the proximal end comprises a disc and the distal end comprises at least one lobe, wherein the disc and the lobe are connected by a connecting member wherein the at least one lobe comprises a proximal portion, a distal portion and a middle portion, wherein the proximal portion transitions into the middle portion in curved transitions and the middle portion transitions into the distal portion in curved transitions, wherein the at least one lobe has an expanded configuration when deployed at the LAA and a reduced configuration for delivery to the LAA, and a plurality of stabilizing wires coupled to the at least one lobe at the middle portion, each stabilizing wire comprising an hook portion extending radially outward from the at least one lobe;
• advancing the medical device to the LAA using a delivery system including a catheter and a delivery cable;
• positioning the medical device relative to the LAA to occlude blood flow;
• and
• de-coupling the medical device from the delivery cable to deploy the medical device.

A method for fabricating a medical device, the method comprising:

• providing a shape-memory material,
• positioning the shape-memory material on a mandrel having a desired shape, size, and radius of curvature for a first transition between a proximal portion of a lobe of the medical and a middle portion of the lobe and a radius of curvature for a second transition between a distal portion of the lobe and the middle portion of the lobe,
• heat setting the shape-memory material to define an expanded preset configuration having the radius of curvature for the first transition and the radius of curvature for the second transition,
• removing the shape-memory material from the mandrel to obtain the medical device in the expanded preset configuration.