DEVICES AND METHODS FOR MEASURING THE SPACE AROUND A NERVE ROOT

• US 20080312660A1
• Filed: 06/16/2008
• Published: 12/18/2008
• Est. Priority Date: 06/15/2007
• Status: Abandoned Application

• Current Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Original Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Inventors: Bleich, Jeffery L., Wallace, Michael P., Yurchenco, James, Schmitz, Gregory P., Bleam, Jefferey, Miller, Eric C., Villalta, Michael
• Application Number:
  US12/140,201
• Publication Number:
  US 20080312660A1
• Time in Patent Office: Days
• US Class Current: 606/102
• 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 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/320008 Scrapers
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/063 for measuring volume
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/4504 Bones A61B5/4547 takes precedence
• CPC Class Codes: A61B 5/4533 Ligaments
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for

Abstract

Described herein are method, systems and devices for measuring the region adjacent to or around a nerve root, such as the space within an intervertebral foramen before, during and/or after a spinal decompression procedure. Measurement devices may be advanced by pulling on them using a guidewire passing through the intervertebral foramen and out of the subject. The measurement device may include sounds for determining one or more dimensions of the space around a nerve root within an intervertebral space, lateral recess or central canal. Various embodiments of sounds, including calibrated, inflatable, expandable, moldable, and tapered sounds (or combinations of these) are described.

Claims

1. A method of measuring the size of a compliant region adjacent to a patient'"'"'s nerve root, the method comprising:

advancing a guidewire from a first position outside of the patient'"'"'s body, through an intervertebral foramen, and out of the patient'"'"'s body at a second position;

advancing a measurement device adjacent to a portion of the nerve root, wherein the measurement device is coupled to the guidewire; and

estimating a size of the compliant region adjacent to the nerve root, based on the advancement of the measurement device.

2. The method of claim 1, wherein advancing the measurement device comprises pulling it into the intervertebral foramen and/or the lateral recess behind the guidewire, wherein the measurement device is coupled to the proximal end of the guidewire.

3. The method of claim 1, wherein multiple measurement devices are provided, each of a different diameter, and wherein estimating the size of the compliant region adjacent to the nerve root comprises determining a largest of the devices that can pass adjacent to the nerve root.

4. The method of claim 1, further comprising expanding an expandable region of the measurement device.

5. The method of claim 4, further comprising

passing fluid into the expandable region of the measurement device to expand the region;

and

estimating the size based on an amount of fluid that can be passed into the expandable portion.

6. The method of claim 1, wherein estimating the size comprises estimating a cross sectional area of the intervertebral foramen.

7. The method of claim 1, wherein estimating the size comprises estimating a volume of the intervertebral foramen.

8. The method of claim 1, further comprising applying neural stimulation from the measurement device and monitoring for EMG signals.

9. The method of claim 1, further comprising molding a moldable region of the measurement device within the compliant region adjacent to the nerve root and withdrawing the molded region.

10. The method of claim 1, wherein guidewire is percutaneously advanced.

11. A method of measuring the size of a compliant region adjacent to a patient'"'"'s nerve root as part of a spinal decompression procedure, the method comprising:

advancing a guidewire from a first position outside of the patient'"'"'s body, through an intervertebral foramen, and out of the patient'"'"'s body at a second position;

pulling the measurement device at least partially into the intervertebral foramen,

wherein the measurement device is coupled to the proximal portion of the guidewire;

expanding a portion of the measurement device; and

estimating a size of the compliant region adjacent to the nerve root, based on the expansion of the measurement device.

12. The method of claim 11, wherein the step of expanding a portion of the measurement device comprises expanding a portion of the measurement device within the intervertebral foramen.

13. The method of claim 11, wherein expanding the portion of the measurement device comprises passing a fluid into the portion.

14. The method of claim 13, wherein the fluid is passed into an expandable balloon of the measurement device.

15. The method of claim 13, wherein the fluid is passed into the portion until it reaches a predetermined pressure.

16. The method of claim 13, wherein the fluid is radiopaque, the method further comprising taking a radiographic image of the expanded portion using a radiographic device.

17. The method of claim 11, further comprising activating a transducer to estimate the size of the expanded portion.

18. The method of claim 11, wherein expanding the portion of the measurement device comprises passing an expansion member into an expandable portion of the device.

19. A measurement device for measuring the size of a compliant region adjacent to a patient'"'"'s nerve root as part of a spinal decompression procedure, the device comprising:

a proximal end configured to be gripped;

a guidewire coupling region at the distal end, the guidewire coupling region configured to mate with the proximal end of a guidewire; and

a sound region near the distal end,

wherein the sound region is configured to be flexibly pulled at least partially through the intervertebral foramen and provide indication of the dimension of the intervertebral foramen.

20. The device of claim 19, wherein the sound region of the measurement device comprises a plurality of calibrated sounds of increasing dimension extending proximally from the distal region.

21. The device of claim 19, wherein the sound region of the measurement device comprises a calibrated tapered region.

22. The device of claim 19, wherein the sound region comprises a plurality of bipolar pairs configured to produce a bipole filed sufficient to activate an adjacent nerve.

23. The device of claim 19, wherein the sound region comprises an expandable region configured to be expanded within the intervertebral foramen.

24. The device of claim 23, wherein the expandable region is an inflatable balloon.

25. The device of claim 23, wherein the measurement device further comprises an expansion member configured to be advanced distally and expand the expandable region.

26. The device of claim 19, wherein the measurement device comprises a moldable region.

27. A system for measuring the size of a compliant region adjacent to a patient'"'"'s nerve root as part of a spinal decompression procedure, the system comprising:

a guidewire having a distal end and a proximal end, and configured to pass from a first position outside of a patient'"'"'s body, through an intervertebral foramen, and out of the patient'"'"'s body at a second position; and

a measurement device including a sound region near the distal end, and a guidewire coupling region at the distal end, the guidewire coupling region configured to mate with the proximal end of the guidewire;

wherein the sound region is configured to be flexibly advanced at least partially through the intervertebral foramen and provide indication of the dimension of the intervertebral foramen.

28. The system of claim 27, wherein the sound region of the measurement device comprises a plurality of calibrated sounds of increasing dimension extending proximally from the distal region.

29. The system of claim 27, wherein the sound region comprises a plurality of bipolar pairs configured to produce a bipole filed sufficient to activate an adjacent nerve.

30. The system of claim 27, wherein the sound region comprises an expandable region configured to be expanded within the intervertebral foramen.

31. The system of claim 30, wherein the expandable region is an inflatable balloon.

32. The system of claim 30, wherein the measurement device further comprises an expansion member configured to be advanced distally and expand the expandable region.

33. The system of claim 27, wherein the measurement device comprises a moldable region.

34. The system of claim 27, wherein the guidewire comprises a shaped proximal end for coupling with the first and second flexible wires.

35. A device for measuring an intervertebral foramen as part of a spinal decompression procedure, the device comprising:

a flexible wire passable through an intervertebral foramen and including a distal tip coupler for coupling with a guidewire; and

a distal tapered sound region fixedly coupled with the flexible wire for passing into the intervertebral foramen;

wherein the tapered sound comprises a moldable material configured to hold the shape of at least a portion of the intervertebral foramen when withdrawn from the intervertebral foramen.

36. A device for measuring an intervertebral foramen as part of a spinal decompression procedure, the device comprising:

a flexible catheter passable into an intervertebral foramen and having proximal and distal ends;

an inflatable balloon disposed along the catheter at or near its distal end; and

a coupler disposed along the catheter at or near its distal end for coupling the catheter with a guidewire.

37. The device of claim 36, further comprising a transducer suspended on a wire passing through the inflatable balloon for measuring the inner dimensions of the balloon.

38. A device as in claim 36, further comprising a second balloon coupled with the catheter at or near its proximal end, wherein the second balloon forms a negative image of the inflatable balloon when the latter is inflated in the intervertebral foramen.

39. A device for percutaneously measuring an intervertebral foramen as part of a spinal decompression procedure, the device comprising:

a flexible catheter configured to pass through an intervertebral foramen, the catheter having proximal and distal portions, and an expansion region;

a plurality of long, flexible expansion members configured to pass into the expansion region, wherein the expansion region is configured to expand as the expansion members are passed therein; and

a guidewire coupling region configured to couple the catheter with a guidewire that can advance the catheter into the foramen.

40. A device as in claim 39, wherein the guidewire coupling region comprises a guidewire coupler at or near the distal end of the catheter for allowing the catheter to be pulled into the foramen behind the guidewire.

41. A device as in claim 39, wherein the guidewire coupling region comprises a guidewire lumen for allowing the catheter to be passed into the foramen over a guidewire.

42. A method of measuring the size of a compliant region adjacent to a patient'"'"'s nerve root, the method comprising:

advancing a guidewire from a first position outside of the patient'"'"'s body, through an intervertebral foramen, and out of the patient'"'"'s body at a second position;

applying an electrical current between a pair of tight bipolar electrodes on a measurement device;

advancing the measurement device until the patient'"'"'s nerve root is stimulated by the applied electrical current, wherein the measurement device is coupled to the guidewire; and

estimating a size of the region adjacent to the nerve root, based on the advancement of the measurement device.