Occluder including external skirt
The present disclosure is directed to embodiments and methods of reducing or eliminating erosion resulting from the use of an occluder, as well as reducing or eliminating other interference with cardiac tissue by an occluder, including reducing pressure on cardiac tissue, minimizing micro-perforations, and/or minimizing residual leak by improving sealing around the occluder. In particular, the present disclosure is directed to providing an external skirt on an occluder that improves sealing of the occluder while reducing interference with the cardiac tissue by the occluder.
1 . A medical device for treating a target site, the medical device comprising:
a tubular member comprising a proximal disc portion at a proximal end, a distal disc portion at a distal end, and a waist member extending between the proximal disc portion and the distal disc portion, wherein the tubular member comprises at least one braided layer of a first material and has an expanded configuration when deployed at the target site and a reduced configuration for delivery to the target site; and
a skirt coupled to an external surface of the tubular member, the skirt comprising at least one layer of a second material softer than the first material, the skirt being attached circumferentially at one end thereof to an external surface of the distal disc portion and loosely draped over the waist member and attached at an opposing end thereof to an external surface of the waist member,
wherein, when the medical device is deployed and the tubular member is in the expanded configuration, the skirt is configured to expand beyond a circumferential profile of the tubular member and radially away from the waist member into a space defined circumferentially around the waist member; and wherein the medical device is an occluding device.
2 . The medical device of claim 1 , wherein the skirt is coupled to the external surface of the distal disc portion by one or more sutures.
3 . The medical device of claim 1 , wherein the skirt is coupled to the external surface of the distal disc portion by thermal bonding.
4 . The medical device of claim 1 , wherein the skirt is formed from one of a synthetic material, preserved tissue, or a fine nitinol braid.
5 . The medical device of claim 1 , wherein a diameter of the skirt is significantly larger than a diameter of the waist member.
6 . The medical device of claim 1 , wherein a diameter of the skirt is significantly larger than a diameter of the waist member and at least one of the proximal disc portion or the distal disc portion.
7 . The medical device of claim 1 , wherein the skirt has a diameter such that the skirt fills a space between the external surface of the waist member and a surface of adjacent tissue, when the medical device is deployed at the target site.
8 . The medical device of claim 1 , wherein the skirt has a diameter such that the skirt extends beyond a circumference of at least one of the proximal disc portion or the distal disc portion and seals against adjacent tissue, when the medical device is deployed at the target site.
9 . The medical device of claim 1 , wherein the skirt includes a plurality of pleats.
10 . A method comprising:
providing a medical device according to claim 1 ;
constraining the medical device from a preset expanded configuration to a reduced configuration;
delivering the medical device; and
deploying the medical device such that the tubular member returns to the preset expanded configuration and the skirt engages a cardiac tissue surrounding one or more of the waist member, the proximal disc portion, or the distal disc portion.
11 . The method of claim 10 , wherein providing the medical device comprises:
determining a diameter of a structure of the cardiac tissue being occluded; and
selecting the medical device with a diameter of the waist member smaller than the diameter of the structure.
12 . The method of claim 11 , further comprising coupling the skirt to the waist member, wherein a diameter of the skirt is significantly larger than the diameter of the waist member.
13 . The method of claim 10 , further comprising coupling the skirt to the distal disc portion, wherein a diameter of the skirt is significantly larger than the diameter of at least one of the waist member, the proximal disc portion, or the distal disc portion.
14 . The method of claim 10 , further comprising coupling the skirt to the distal disc portion using a plurality of sutures.
15 . A medical device for treating a target site, the medical device comprising:
a tubular member comprising a disc portion at a first end, a lobe at a second end, and a waist member extending between the disc portion and the lobe, wherein the tubular member comprises at least one braided layer of a first material and has an expanded configuration when deployed at the target site and a reduced configuration for delivery to the target site; and
a skirt coupled to an external surface of the tubular member, the skirt being attached circumferentially at one end thereof to an external surface of the lobe and loosely draped over the waist member and attached at an opposing end thereof to an external surface of the waist member, the skirt comprising at least one layer of a second material softer than the first material,
wherein, when the medical device is deployed and the tubular member is in the expanded configuration, the skirt is configured to expand beyond a circumferential profile of the tubular member and radially away from the waist member into a space defined circumferentially around the waist member; and wherein the medical device is an occluding device.
16 . The medical device of claim 15 , wherein the skirt is coupled to the external surface of the lobe by one or more sutures.
17 . The medical device of claim 15 , wherein a diameter of the skirt is significantly larger than a diameter of the waist member and at least one of the disc portion or the lobe.
18 . The medical device of claim 15 , wherein the skirt includes a plurality of pleats.