Medical devices for shunts, occluders, fenestrations and related systems and methods
An implantable medical device comprising a first frame portion, a second frame portion arranged within the first frame portion and a plurality of diverging elements connecting the first frame portion to the second frame portion.
1 . An implantable medical device, comprising:
a first frame portion having at least three lobes;
a second frame portion arranged within the first frame portion, wherein the first frame portion and the second frame portion are coplanar with one another within a plane when the device is in an unconstrained configuration, wherein the plane is orthogonal to a longitudinal axis of the implantable medical device, and wherein at least a portion of the first and second frame portions are nonplanar with one another when the device is in a delivery configuration; and
a plurality of diverging elements arranged between the first frame portion and the second frame portion, the plurality of diverging elements diverge from the first frame portion and the second frame portion to form a central frame with at least six diverging points in a deployed configuration.
2 . The device of claim 1 , wherein the first frame portion and the second frame are contiguous with one another.
3 . The device of claim 1 , wherein the central frame defines an opening that is hexagonal in shape when the device is in a deployed configuration.
4 . The device of claim 1 , wherein the first frame portion is located on a first side of a septum, the second frame portion is located on a second side of the septum, and the plurality of diverging elements form a fluid flow path therethrough.
5 . The device of claim 4 , wherein the first and second frame portions are sufficiently flexible to conform to an anatomy of the septum.
6 . The device of claim 1 , wherein the second frame portion includes at least three lobes.
7 . The device of claim 1 , wherein the first frame portion has a first geometry and the second frame portion has a second geometry that is different from the first geometry.
8 . The device of claim 1 , wherein the first frame portion includes six lobes.
9 . The device of claim 1 , wherein each of the lobes of the second frame portion comprises an eyelet configured to aid in delivery of the device.
10 . The device of claim 1 , further comprising a covering material arranged on at least a portion of the device.
11 . The device of claim 10 , wherein the first frame portion includes the covering material and the second frame portion is free of the covering material.
12 . The device of claim 11 , wherein the covering material includes expanded polytetrafluoroethylene (ePTFE).
13 . The device of claim 1 , wherein the first frame portion and the second frame portion are unitary such that the device is formed of a single wire.
14 . The device of claim 1 , further comprising at least one of a coating of heparin to facilitate thromboresistance and patency of the device and a coating of paclitaxel to modulate tissue/cellular response.
15 . The device of claim 1 , wherein the longitudinal axis extends through a center of a lumen defined by the implantable medical device and the plane extends through a portion of the lumen.
16 . The device of claim 1 , wherein the at least three lobes extend perpendicularly to the longitudinal axis in the unconstrained configuration.