Tissue modification devices
View Patent ↗Described herein are elongate devices for modifying tissue having a plurality of flexibly connected rungs or links, and methods of using them, including methods of using them to decompress stenotic spinal tissue. These devices may be included as part of a system for modifying tissue. In general, these devices include a plurality of blades positioned on (or formed from) rungs that are flexibly connected. The rungs are typically rigid, somewhat flat and wider than they are long (e.g., rectangular). The rungs may be arranged, ladder like, and may be connected by a flexible connector substrate or between two or more cables. Different sized rungs may be used. The blades (on the rungs) may be arranged in a staggered arrangement. A tissue-collection or tissue capture element may be used to collect the cut or modified tissue.
1. A flexible tissue-modification device for removing tissue from a patient, the device comprising:
a flexible elongate body having an axial length, a width and a thickness, wherein the axial length is greater than the width, and the width is greater than the thickness;
wherein the flexible elongate body includes a plurality of rungs that are flexibly connected between a first length of cable extending proximally and distally and a second length of cable extending proximally and distally, wherein each rung extends between the first and second lengths of cable and at least partially across the width of the flexible elongate body;
a guidewire coupler secured to the distal end of the first and second lengths of cable, wherein the guidewire coupler has an opening to receive a guidewire;
a tissue collection region in communication adjacent to the plurality of rungs, wherein the tissue collection region is movable with respect to the rungs so that it may move distally or proximally as the tissue-modification device bends; and
at least one cutting edge on two or more of the plurality of rungs.
2. The device of claim 1 , further wherein the rungs of the plurality of rungs are sufficiently rigid that they do not deflect when tension is applied along the length from the ends of the flexible elongate body.
3. The device of claim 1 , wherein the axial length of the rungs of the plurality of rungs is less than the width of the rungs of the plurality of rungs.
4. The device of claim 1 , wherein the the first and second lengths of cable comprise a flexible material.
5. The device of claim 1 , wherein the first and second lengths of cable comprises a single cable.
6. The device of claim 1 , wherein the flexible elongate body is ribbon-shape, having a width that is greater than the thickness.
7. The device of claim 1 , further comprising a handle or a handle attachment region at a proximal end of the device.
8. The device of claim 1 , further comprising at least one protective side guard extending along the axial length of the flexible elongate body.
9. The device of claim 1 , further comprising at least one spacer between adjacent rungs of the plurality of rungs.
10. The device of claim 1 , wherein the at least one cutting edge projects from the surface of each rung of the plurality of rungs.
11. The device of claim 1 , wherein the cutting edges on adjacent rungs of the plurality of rungs are axially offset from each other.
12. A flexible elongate tissue-modification device, comprising:
a flexible elongate body extending distally to proximally and having a length and a width, the flexible elongate body extending distally and proximally along the length, wherein the length is greater than the width;
a plurality of rungs that are flexibly connected between a first length of cable extending proximally and distally and a second length of cable extending proximally and distally, wherein each rung extends between the first and second lengths of cable and across the width of the flexible elongate body;
at least one cutting edge on two or more of the rungs of the plurality of rungs;
a guidewire coupler secured to the distal end of the first and second lengths of cable, wherein the guidewire coupler has an opening to receive a guidewire; and
a tissue collection region adjacent to each rung of the plurality of rungs, wherein the tissue collection region has a minimum open space defined by the space between the rungs of the plurality of rungs and a tissue collection substrate that extends at least partially proximally and distally, wherein the tissue collection substrate is movable with respect to the rungs so that it may move distally or proximally as the tissue-modification device bends.
13. The device of claim 12 , wherein the tissue collection region comprises a plurality of connectors connecting the tissue collection substrate with the rungs.
14. The device of claim 12 , wherein the tissue collection substrate is extendable in the proximal/distal direction.
15. The device of claim 14 , wherein the tissue collection substrate comprises an accordion region configured to expand or contract the tissue collection substrate in the proximal/distal direction.
16. The device of claim 14 , wherein the tissue collection substrate is connected to the flexible elongate body by an expandable connector that allows the tissue collection substrate to extend or contract proximally and distally as the tissue-modification device is bent.
17. The device of claim 12 , wherein the tissue collection substrate comprises an expandable material that allows the tissue collection substrate to expand as the tissue collection region is filled.
18. The device of claim 12 , further comprising a handle or handle attachment region in communication with the proximal end of the flexible elongate body.
19. A flexible tissue-modification device for removing tissue from a patient, the device comprising:
a flexible elongate body having a length, a width and a thickness, wherein the length is greater than the width, and the width is greater than the thickness;
a plurality of rungs that are flexibly connected between a first length of cable extending proximally and distally and a second length of cable extending proximally and distally, wherein each rung extends between the first and second lengths of cable and across the width of the flexible elongate body and forms an anterior surface;
at least one cutting edge on two or more of the rungs;
wherein the flexible tissue-modification device is convertible from a first configuration, in which the anterior surface has a first proximal to distal shape, and a second configuration, in which the anterior surface has a second proximal to distal shape;
a guidewire coupler secured to the distal end of the first and second lengths of cable, wherein the guidewire coupler has an opening to receive a guidewire; and
a lock for locking the proximal to distal shape of the anterior surface of the tissue-modification device.
20. The device of claim 19 , further comprising a pull wire extending proximally and distally in the device and configured to change the shape of the proximal to distal shape of the anterior surface by applying tension to the pull wire.
21. The device of claim 19 , wherein the first proximal to distal shape of the anterior surface is linear.
22. The device of claim 19 , wherein the second proximal to distal shape of the anterior surface is curved.
23. The device of claim 19 , wherein the second proximal to distal shape is C-shaped.
24. The device of claim 19 , wherein the second proximal to distal shape is S-shaped.
25. The device of claim 19 , further comprising a handle or handle attachment region in communication with the proximal end of the flexible elongate body.
26. The device of claim 19 , further comprising a tissue collection region.