Occlusive material for medical device, system, and method thereof
Medical devices, systems and methods for forming an occlusive material for occluding a left atrial appendage of a heart are provided. In one embodiment, the occlusive material includes a foam portion that extends as a single piece, seamless monolithic structure that is sized to couple to an external side of a framework of a medical device. In another embodiment, the occlusive material may include a polymeric laminate. Such polymeric laminate may be adhered to an outer side of the foam portion. Further, various embodiments for forming a polymer laminate are provided.
1 . A medical device for occluding a left atrial appendage of a heart, comprising:
a framework including occluder frame segments coupled to a hub defining an axis, the occluder frame segments of the framework extending radially outward and distally relative to the axis from the hub to a distal end such that the occluder frame segments extend to define an internal surface and an external surface of the occluder frame segments; and
an occluder member including:
a foam portion of the occluder member extending entirely with a single piece, seamless monolithic structure having a cup-like shape defining an internal side foam surface and an external side foam surface extending between a proximal foam end and a distal foam end, the foam portion sized and configured to correspond with the external surface of the occluder frame segments of the framework, the internal side foam surface of the foam portion being positionable against the external surface of the occluder frame segments of the framework such that the proximal foam end is positionable adjacent the hub and the distal foam end is positionable adjacent the distal end of the occluder frame segments; and
a polymeric laminate directly attached to the external side foam surface of the foam portion between the proximal foam end and the distal foam end, the polymeric laminate having an outer surface extending to define a stepped profile, the stepped profile including at least a first outer surface, a second outer surface, and a third outer surface;
wherein each of the first outer surface, the second outer surface and the third outer surface corresponds with a respective first layer, a second layer, and a third layer.
2 . The medical device of claim 1 , wherein the foam portion extends to define an opening therein such that the proximal foam end defines the opening of the foam portion.
3 . The medical device of claim 1 , wherein the foam portion extends with a substantially consistent thickness.
4 . The medical device of claim 1 , wherein the foam portion is configured to be stitched to portions of the framework.
5 . The medical device of claim 1 , wherein the polymeric laminate is adhesively attached to the external side foam surface of the foam portion.
6 . The medical device of claim 1 , wherein the foam portion comprises a biodegradable material extending with a scaffold structure, the scaffold structure sized and configured to induce tissue in-growth therein.
7 . The medical device of claim 1 , wherein the single piece, seamless monolithic structure is a molded structure.
8 . The medical device of claim 1 , wherein the framework comprises anchor frame segments coupled to the occluder frame segments.
9 . The medical device of claim 1 , wherein the framework comprise tines coupled thereto.
10 . The medical device of claim 1 , wherein the framework comprises anchor frame segments coupled to the occluder frame segments with hinges such that a hood portion of the polymeric laminate extends over the hinges.
11 . The medical device of claim 1 , wherein the framework comprises anchor frame segments, the anchor frame segments pivotably coupled to the occluder frame segments such that anchor frame segments include an anchor hub, the anchor hub moveable along the axis defined by the hub.
12 . The medical device of claim 1 , the polymeric laminate positioned to extend beyond the distal foam end of the foam portion so as to define a hood portion of the polymeric laminate, the hood portion extending over a portion of the framework.
13 . The medical device of claim 1 , wherein the stepped profile of the polymeric laminate defines at least a first thickness, a second thickness, and a third thickness.
14 . A medical device for occluding a left atrial appendage of a heart, comprising:
a framework including occluder frame segments coupled to a hub defining an axis, the occluder frame segments of the framework extending radially outward and distally relative to the axis from the hub to a distal end such that the occluder frame segments extend to define an internal surface and an external surface of the occluder frame segments; and
an occluder member including:
a foam portion of the occluder member extending entirely with a single piece, seamless monolithic structure having a cup-like shape defining an internal side foam surface and an external side foam surface extending between a proximal foam end and a distal foam end, the foam portion sized and configured to correspond with the external surface of the occluder frame segments of the framework, the internal side foam surface of the foam portion being positionable against the external surface of the occluder frame segments of the framework such that the proximal foam end is positionable adjacent the hub and the distal foam end is positionable adjacent the distal end of the occluder frame segments; and
a polymeric laminate directly attached to the external side foam surface of the foam portion between the proximal foam end and the distal foam end, the polymeric laminate having an outer surface extending to define a stepped profile, the stepped profile including at least a first outer surface, a second outer surface, and a third outer surface;
wherein the stepped profile of the polymeric laminate defines at least a first thickness, a second thickness, and a third thickness.
15 . The medical device of claim 14 , wherein the foam portion extends to define an opening therein such that the proximal foam end defines the opening of the foam portion.
16 . The medical device of claim 14 , wherein the foam portion extends with a substantially consistent thickness.
17 . The medical device of claim 14 , wherein the polymeric laminate is adhesively attached to the external side foam surface of the foam portion.
18 . The medical device of claim 14 , wherein the foam portion comprises a biodegradable material extending with a scaffold structure, the scaffold structure sized and configured to induce tissue in-growth therein.
19 . The medical device of claim 14 , wherein the single piece, seamless monolithic structure is a molded structure.
20 . The medical device of claim 14 , wherein each of the first outer surface, the second outer surface and the third outer surface corresponds with a respective first layer, a second layer and a third layer.