Tissue modification devices

• US 8,845,639 B2
• Filed: 01/14/2011
• Issued: 09/30/2014
• Est. Priority Date: 07/14/2008
• Status: Active Grant

• Current Assignee: Spinal Elements, Inc.
• Original Assignee: Baxano Surgical, Inc.
• Inventors: Wallace, Michael P., Garabedian, Robert, Schmitz, Gregory P., Bleich, Jeffery L., Cantorna, Nestor C., Leguidleguid, Ronald, Leguidleguid, Roy, Sheinberg, Michael
• Primary Examiner(s): BATES, DAVID W
• Application Number:
  US13/007,381
• Publication Number:
  US 20110112539A1
• Time in Patent Office: 1,355 Days
• Field of Search: 29/811, 29/811.7, 606/82, 606/85
• US Class Current: 606/85
• CPC Class Codes: A61B 17/149 Chain, wire or band saws
• CPC Class Codes: A61B 17/1659 Surgical rasps, files, planes, or scrapers
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320008 Scrapers
• CPC Class Codes: A61B 2017/32006 with a cutting strip, band or chain, e.g. like a chainsaw
• CPC Class Codes: A61B 2017/32008 preventing clogging of suction channel
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image

Abstract

Described herein are elongate devices for modifying tissue having a plurality of flexibly connected and 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 for formed from) rungs that are flexibly connected and may be separated by one or more spacers. The rungs are typically 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, or rungs with different cutting properties. In some variations the tissue modification devices may have a non-linear axial shape, or may be converted from a first axial shape to a second axial shape.

Claims

1. A flexible tissue-modification device for removing tissue from a patient, the device having an elongate body with 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, the device comprising:

a flexible connector extending longitudinally along the axial length of the elongate body;

a plurality of rigid tissue-cutting rungs that are flexibly connected by the connector, wherein each rung in the plurality of tissue-cutting rungs extends at least partially across the width of the elongate body;

at least one cutting edge on each of the tissue-cutting rungs;

a plurality of spacers, wherein each rung in the plurality of tissue-cutting rungs is separated from an adjacent rung by a spacer, wherein the spacer forms an opening though the device between adjacent rungs that extends across the width of the elongate body; and

a guidewire coupler attached to the connector at a distal end of the device, wherein the guidewire coupler includes a tapered distal end region that is configured to fit an enlarged proximal end of a guidewire so that the guidewire engages with the guidewire coupler when pulled distally.

2. The device of claim 1, wherein the plurality of tissue-cutting rungs comprises rungs having different configurations or sizes.

3. The device of claim 1, wherein the connector comprises at least one cable.

4. The device of claim 1, further comprising at least one protective side guard extending along the axial length of the elongate body.

5. The device of claim 1, wherein the cutting edge projects from a surface of the rung.

6. The device of claim 1, further comprising a tissue collection region in communication with the rung.

7. The device of claim 1, wherein the opening through the device is configured to provide a passage between adjacent rungs.

8. The device of claim 1, wherein the spacer is a ferrule.

9. The device of claim 1, wherein the plurality of rigid tissue-cutting rungs and the plurality of spacers are threaded on the connector.

14. The device of claim 1, further comprising a proximal handle attached to the connector.

15. The device of claim 1, wherein the connector comprises at least two flexible elongate cables, wherein the cables extend substantially adjacent to each other from a proximal end region of the device to a distal end region of the device.

16. The device of claim 1, wherein the plurality of rigid, tissue-cutting rungs are I-shaped such that the spacer is integral with the rung.

10. A flexible tissue-modification device for removing tissue from a patient, the device having an elongate body with 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, the device having an anterior, tissue-facing surface, the device comprising:

a proximal handle;

a flexible connector extending longitudinally along the axial length of the device from the handle;

a first set of rigid tissue-cutting rungs that are flexibly connected to the connector, wherein the first set of tissue-cutting rungs include at least one first cutting edge projecting from the anterior surface of and positioned between lateral edges of each rung of the first set of rigid tissue-cutting rungs and each first cutting edge extends substantially perpendicular to the axial length;

a second set of rigid tissue-cutting rungs that are flexibly connected to the connector, wherein the second set of tissue-cutting rungs include at least one second cutting edge projecting from the anterior surface of and extending along the axial length of a lateral edge of each rung of the second set of rigid tissue-cutting rungs, each second cutting edge extending substantially along the axial length; and

a guidewire coupler attached to the connector at a distal end of the device.

11. The device of claim 10, wherein each second cutting edge is sized and configured to cut a strip of soft tissue.

12. The device of claim 11, wherein each second cutting edge includes a tombstone shaped edge.

13. The device of claim 11, wherein the soft tissue is ligamentum flavum.

17. A flexible tissue-modification device for removing tissue from a patient, the device having an elongate body with 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, the device comprising:

a flexible connector comprising two lengths of cable extending adjacently along the axial length of the device;

a plurality of rigid, tissue-cutting rungs that are connected to the lengths of cable, wherein each rung extends at least partially across the width of the body between the two lengths of cable and is separated from adjacent rungs by a spacer forming an opening though the device between adjacent rungs;

a cutting edge on each of the tissue-cutting rungs; and

a guidewire coupler attached to the connector at a distal end of the device, wherein the guidewire coupler includes a tapered distal end region that is configured to fit an enlarged proximal end of a guidewire so that the guidewire engages with the guidewire coupler when pulled distally.

18. The device of claim 17, wherein the spacer is integral with the rung.

19. The device of claim 17, wherein the spacer is separate from the rung and positioned between adjacent rungs.