1. A nuclear prosthesis for percutaneous implantation into a de-nucleated inter-vertebral disc space of a human, said nuclear prosthesis comprising:
an annular enclosing layer substantially discoid in shape and defining an annular enclosure;
an annular reinforcement band adjacent an outer margin of said annular enclosing layer and defining an outer layer of said nuclear prosthesis; said annular reinforcement band comprises a plurality of at least partially interwoven layers of biocompatible fibers, thereby comprising a three dimensional structure of said annular reinforcement band, the three dimensional structure comprising;
a warp knitted outer layer for enhancing in-growth of soft tissue to said nuclear prosthesis;
at least one intermediate layer formed of a plurality of substantially helical loops of said biocompatible fibers;
an inner layer formed of thin biocompatible fibers; and
wherein said outer layer and said at least one intermediate layer are adjacent and partially interwoven, and said at least one intermediate layer and said inner layer are adjacent and partially interwoven;
a nuclear enclosing layer adjacent an inner margin of said annular enclosing layer, said nuclear enclosing layer enclosing and defining a nuclear enclosure;
a sealing valve assembly comprising a sealing valve core disposed within said annular enclosure and bonded to said annular enclosing layer, an indwelling catheter partially enclosed within said nuclear enclosure and extending outward through said nuclear enclosing layer, said inner margin of said annular enclosing layer and into said sealing valve core such that the remaining portion of said indwelling catheter is enclosed within said sealing valve core, and a sealing plug insertable within said indwelling catheter; and
wherein said sealing valve assembly conducts compressible fluid into said nuclear enclosure and deformable fluid into said annular enclosure and said sealing valve assembly further comprises:
an inlet port disposed within said sealing valve core and lateral to said indwelling catheter, said inlet port opening into said annular enclosure for said conduction of said fluid into said annular enclosure; and
wherein said indwelling catheter has a pore for conduction of said fluid into said nuclear enclosure; and
wherein said sealing valve core further comprises an outlet port substantially opposite said inlet port and lateral to said indwelling catheter, said outlet port having an opening into said annular enclosure for receiving a return of said fluid that is conducted into said annular enclosure.
2. The nuclear prosthesis as recited in claim 1 wherein said indwelling catheter further comprises a connection terminal for detachably receiving a central tube of an inflation stylus to conduct said fluid into said nuclear enclosure.
3. The nuclear prosthesis as recited in claim 2 further comprising:
a nuclear mounting region having a predefined nuclear slot along a side of said sealing valve core adjacent said inner margin of said annular enclosing layer, said nuclear slot receiving said indwelling catheter and a connector terminal of said nuclear enclosing layer;
wherein said connector terminal comprises a neck portion of said nuclear enclosing layer and a retaining collar encompassing said neck portion of said nuclear enclosing layer, said connector terminal receiving and bonding to said indwelling catheter snugly to create a fluid-tight bond.
4. The nuclear prosthesis as recited in claim 1 further comprising:
a nuclear mounting region having a predefined nuclear slot along a side of said sealing valve core adjacent said inner margin of said annular enclosing layer, said nuclear slot receiving said indwelling catheter and a connector terminal of said nuclear enclosing layer;
wherein said connector terminal comprises a neck portion of said nuclear enclosing layer and a retaining collar encompassing said neck portion of said nuclear enclosing layer, said connector terminal receiving and bonding to said indwelling catheter snugly to create a fluid-tight bond.
5. The nuclear prosthesis as recited in claim 1 wherein said inlet port, said outlet port and said indwelling catheter have corresponding pathways terminating with bores for receiving and creating detachable, but fluid tight connections with corresponding tubes of said inflation stylus.
6. The nuclear prosthesis as recited in claim 5 wherein said sealing valve core has: an outer diameter slightly smaller than the diameter of the annular enclosing layer;
an annular mounting region comprising an annular slot adjacent said outer margin of said annular enclosing layer for receiving a portion of said outer margin, said annular slot extending around a radial circumference of said sealing valve core; and
wherein said nuclear mounting region of said sealing valve core further comprising said annular slot for receiving said a portion of said inner margin of said annular enclosing layer.
7. The nuclear prosthesis as recited in claim 6 wherein said sealing valve core is bonded to said annular enclosing layer by a retaining ring surrounding said sealing valve core, said retaining ring receiving and crimping to said annular slot m said nuclear mounting region and said annular mounting region.
8. The nuclear prosthesis as recited in claim 1 wherein said fluid conducted into said nuclear enclosure is a liquid and said fluid conducted into said annular enclosure is a curable rubber.
9. The nuclear prosthesis as recited in claim 1 wherein said fluid conducted into said nuclear enclosure is a gas and said fluid conducted into said annular enclosure is a curable rubber.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
1. A medical device comprising:
an elongate shaft having a proximal end, a distal end portion including a distal end, and a balloon disposed at least partially within the distal end portion;
wherein the distal end portion is configured to selectively expand from a collapsed delivery configuration to a distally-opening expanded filtering configuration;
wherein the distal end has a first outer diameter in the collapsed delivery configuration and a second outer diameter in the expanded filtering configuration.
2. The medical device of claim 1, wherein the distal end portion is configured to selectively expand in response to inflation of the balloon.
3. The medical device of claim 2, wherein the balloon expands the distal end to the second outer diameter.
4. The medical device of claim 2, wherein the balloon is configured to at least partially expand the distal end to at least an intermediate outer diameter, wherein at an outer diameter larger than the intermediate outer diameter, the distal end is self-biased toward the second outer diameter.
5. The medical device of claim 4, wherein the distal end portion includes a bistable structure.
6. The medical device of claim 5, wherein at an outer diameter less than the intermediate outer diameter, the distal end is self-biased toward the first outer diameter.
7. The medical device of claim 5, wherein the bistable structure includes a circumferentially-oriented support hoop formed from the elongate shaft.
8. The medical device of claim 5, wherein the bistable structure includes an expandable mesh formed from the elongate shaft.
9. The medical device of claim 5, wherein the bistable structure includes a plurality of longitudinally-oriented struts formed from the elongate shaft.
10. The medical device of claim 9, wherein the bistable structure includes a filter membrane disposed within the plurality of longitudinally-oriented struts.
11. The medical device of claim 1, wherein the distal end portion forms a distal protection filter in the expanded filtering configuration.
12. The medical device of claim 11, wherein an inner diameter of the elongate shaft at the distal end in the expanded filtering configuration is greater than an outermost extent of the balloon.
13. The medical device of claim 12, wherein the distal end of the elongate shaft is radially spaced apart from the balloon in the expanded filtering configuration.
14. The medical device of claim 1, wherein the distal end portion is formed from a shape memory material configured to self-expand to the expanded filtering configuration.
15. The medical device of claim 1, wherein the balloon is configured for placement at least partially within an aortic valve such that the distal end of the elongate shaft is disposed downstream of the aortic valve.
16. The medical device of claim 1, wherein the medical device further includes a transcatheter aortic valve implantation device disposed on the balloon.
17. A method of deploying a medical device at a treatment site, comprising:
obtaining an elongate shaft having a proximal end, a distal end portion including a distal end, and a balloon disposed at least partially within the distal end portion and extending distally therefrom, wherein the distal end portion is configured to selectively expand from a collapsed delivery configuration to a distally-opening expanded filtering configuration;
advancing the elongate shaft through a vessel in a retrograde direction to the treatment site;
disposing at least a portion of the balloon within the treatment site such that the distal end of the elongate shaft is positioned adjacent the treatment site;
at least partially inflating the balloon, thereby expanding the distal end of the elongate shaft to the expanded filtering configuration, wherein the distal end substantially conforms to an inner surface of the vessel adjacent to the treatment site; and
deflating the balloon and subsequently performing a valvectomy, valvuloplasty, or transcatheter aortic valve implantation procedure with the distal end of the elongate shaft positioned within the vessel adjacent to the treatment site in the expanded filtering configuration.
18. The method of claim 17, wherein at least partially inflating the balloon transitions the distal end portion from an inwardly-biased state to an outwardly-biased state.
19. The method of claim 18, wherein the distal end portion includes a bistable structure.
20. The method of claim 17, wherein in the expanded filtering configuration, the distal end of the elongate shaft is radially spaced apart from the balloon.