Method and system for treating valve stenosis
A valvuloplasty catheter comprises a balloon or other expansible shell which carries a plurality of scoring elements, typically formed in an elastic, self-closing metal cage. The expansible shell and scoring elements are positioned inside an aortic or other cardiac valve, and the shell expanded to engage the scoring elements against stenotic material which covers the valve leaflets and valve annulus. The scoring elements uniformly distributed force to break up the stenotic material, and the cage further contributes to rapid balloon deflation allowing shortening of the treatment time.
1. A device for treating cardiac valve stenoses, the device comprising:
a shaft comprising a distal region and a longitudinal axis;
a non-distensible inflatable balloon disposed on the distal region of the shaft, wherein the non-distensible inflatable balloon comprises a proximal end and a distal end; and
a scoring element comprising:
a plurality of axial struts, wherein the axial struts are circumferentially disposed over the non-distensible inflatable balloon, wherein each axial strut comprises a proximal end and distal end;
a proximal zig-zag ring coupled to the proximal ends of the axial struts, wherein. the proximal zig-zag ring is disposed over the non -distensible inflatable balloon;
a distal zig-zag ring coupled to the distal ends of the axial struts, wherein the distal zig-zag ring is disposed over the non-distensible inflatable balloon, wherein the plurality of axial struts, the proximal zig -zag ring, and the distal zig-zag ring form a plurality of elongated hexagonal cells, wherein the plurality of elongated hexagonal cells are entirely disposed over the non-distensible inflatable balloon and parallel to the longitudinal axis when the non-distensible inflatable balloon is in an inflated state, wherein the non-distensible inflatable balloon comprises a diameter that fully occupies an adult human cardiac valve annulus in the inflated state;
at least one proximal connecting link extending proximally of the proximal zig-zag ring and coupling the proximal zig-zag ring to the shaft;
at least one distal connecting link extending distally of the distal zigzag ring and coupling the distal zig-tag ring to the shaft; and
a tube comprising a proximal and a distal end, wherein the distal end of the tube is coupled to the at least one proximal connecting link and the proximal end of the tube is coupled to the shaft to permit elongation of the tube along the longitudinal axis when the non-distensible inflatable balloon is in the inflated state.
2. A device according to claim 1 , wherein the at least one proximal connecting link comprises a plurality of proximal connecting links.
3. A device according to claim 2 , wherein the at least one distal connecting link comprises a plurality of distal connecting links.
4. A device according to claim 2 , wherein the plurality of proximal connector links and the proximal zig-zag ring define a plurality of kite -shaped cells when the non-distensible inflatable balloon is in the inflated state.
5. A device according to claim 1 , wherein the at least one distal connecting link comprises a plurality of distal connecting links.
6. A device according to claim 5 , wherein the least one proximal connecting link comprises a plurality of proximal connecting links.
7. A device according to claim 5 , wherein the plurality of distal connector links and the distal ring define a plurality of kite-shaped cells disposed when the non-distensible inflatable balloon is in the inflated state.
8. A device according to claim 1 , wherein the axial struts have a rectangular cross-section with a height in the radial direction in the range from 0.1 mm 04 mm and a width in the circumferential direction in the range from 0.25 mm to 0.5 mm.
9. A device according to claim 1 , wherein the scoring element is capable of contracting to a diameter in the range of from 3 mm to 7 mm.
10. A device according to claim 1 , wherein the axial struts are evenly spaced.
11. A device according to claim 1 , wherein the scoring element comprises at least six axial struts.
12. A device according to claim 1 , wherein the axial struts are evenly spaced.
13. A device according to claim 1 , wherein the scoring element comprises between six and twenty axial struts.
14. A device according to claim 13 , wherein the scoring element comprises between eight and sixteen axial struts.
15. A device according to claim 13 , wherein the scoring element is capable of expanding to a diameter between twenty millimeters and thirty millimeters.
16. A device according to claim 1 wherein the tube is rotatably coupled to the shaft to permit rotation of the non-distensible rotatable balloon relative to the shaft.
17. A device according to claim 1 wherein the tube is unattached to the shaft except for an attachment point at the proximal end of the tube.