Multi-layered medical device for treating a target site and associated method
Embodiments of the present invention provide medical devices and methods for treating a target site within the body, such as for treating vascular abnormalities. For example, one embodiment provides an occlusion device including an occlusive material having proximal and distal ends and a central axis extending therebetween. The occlusive material has a preset, overlapping configuration including at least three inverted overlapping layers folded over one another, wherein the at least three inverted overlapping layers are aligned with the central axis within about 45 degrees or less and are configured to be separated and disposed within a catheter in a non-overlapping configuration and return to the preset, overlapping configuration when deployed from the catheter.
1. An occlusion device for occluding a target site, the device comprising:
an occlusive material comprising a tubular fabric having proximal and distal ends and a central axis extending therebetween, each of the proximal and distal ends being secured at a point along the central axis such that the tubular fabric is configured to at least partially inhibit blood flow between the proximal and distal ends, the occlusive material having a preset, overlapping configuration comprising at least three overlapping layers folded over each other by inversion such that the at least three overlapping layers overlap one another along the central axis and such that substantially an entire length of an innermost layer of the at least three overlapping layers and substantially an entire length of an outermost layer of the at least three overlapping layers are spaced apart from one another along a radial axis that is perpendicular to the central axis, wherein the at least three overlapping layers are aligned with the central axis within about 45 degrees or less and are configured to be separated and disposed within a catheter in a non-overlapping configuration and to at least partially return to the preset, overlapping configuration when deployed from the catheter and wherein at least one pair of the at least three overlapping layers that are directly next to each other are folded greater than 180 degrees with respect to one another in the preset, overlapping configuration, one of the at least three overlapping layers having a free end secured at the proximal or distal end such that a remaining unsecured portion of the layer extending from the free end defines an outer surface configured to be exposed to blood flow at the target site.
2. The occlusion device of claim 1 , wherein the occlusive material comprises a plurality of strands braided into a continuous layer of tubular fabric.
3. The occlusion device of claim 2 , wherein the tubular fabric comprises braided strands of a shape memory alloy, each metal strand having a pair of free ends.
4. The occlusion device of claim 3 , further comprising at least one clamp configured to secure a free end of each of the braided metal strands.
5. The occlusion device of claim 4 , wherein the device has a proximal end and a distal end and the at least one clamp is located distally with respect to the proximal end of the device or proximally with respect to the distal end of the device in the preset, overlapping configuration.
6. The occlusion device of claim 4 , wherein the at least one clamp further comprises a pair of clamps, each clamp configured to secure respective free ends of the braided metal strands.
7. The occlusion device of claim 6 , wherein at least a portion of each overlapping layer is located exteriorly of each of the pair of clamps.
8. The occlusion device of claim 4 , wherein at least a portion of each overlapping layer is located exteriorly of the at least one clamp.
9. The occlusion device of claim 1 , wherein the occlusive material further comprises a plurality of layers extending perpendicularly to the central axis in the preset, overlapping configuration.
10. The occlusion device of claim 1 , wherein the occlusive material is configured to be axially elongated to separate the at least three overlapping layers into the non-overlapping configuration.
11. The occlusion device of claim 1 , wherein the occlusive material comprises an inner surface and an outer surface in the non-overlapping configuration, and wherein at least a portion of the occlusive material is configured to fold over itself such that a portion of the outer surface overlies another portion of the outer surface.
12. The occlusion device of claim 1 , wherein at least one overlapping layer overlaps at least 50% of another overlapping layer.
13. The occlusion device of claim 1 , wherein at least a pair of the at least three overlapping layers include surface portions that are configured to be substantially parallel to one another and the central axis in the preset, overlapping configuration.
14. The occlusion device of claim 1 , wherein the occlusive material is configured to be constrained to an outer diameter of less than about 11 French for delivery within a catheter in the non-overlapping configuration.
15. The occlusion device of claim 1 , wherein a portion of at least one of the three overlapping layers of the occlusive material comprises a cylindrical outer surface extending parallel to the central axis in the preset, overlapping configuration.
16. The occlusion device of claim 15 , wherein a portion of one of the at least three overlapping layers comprises a surface extending obliquely with respect to the central axis and within the cylindrical outer surface.
17. The occlusion device of claim 16 , wherein a portion of the oblique surface is curved.
18. The occlusion device of claim 16 , wherein a portion of the oblique surface is configured to abut the cylindrical outer surface.
19. The occlusion device of claim 1 , wherein a cross-section of the occlusive material is symmetrical about an axis extending perpendicular to the central axis in the preset, overlapping configuration.
20. The occlusion device of claim 1 , wherein a cross-section of the occlusive material is symmetrical about an axis extending perpendicular to the central axis in the preset, overlapping configuration.