Spinal access and neural localization

• US 7,578,819 B2
• Filed: 07/13/2006
• Issued: 08/25/2009
• Est. Priority Date: 05/16/2005
• Status: Active Grant

• Current Assignee: Spinal Elements, Inc.
• Original Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Inventors: Bleich, Jeffery L., Bleam, Jefferey, Leguidleguid, Ron
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Pani; John
• Application Number:
  US11/457,416
• Publication Number:
  US 20060258951A1
• Time in Patent Office: 1,139 Days
• Field of Search: 600/546, 600/554, 600/547, 600/548, 606/117, 607/48, 607115-117
• US Class Current: 606/53
• CPC Class Codes: A61B 17/1626 Control means; Display units
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/8861 Apparatus for manipulating flexible wires or straps devices for inserting Kirschner wires A61B17/1697
• CPC Class Codes: A61B 17/8897 Guide wires or guide pins

Abstract

A method in which a probe is advanced between a neural tissue structure and a non-neural tissue structure such as the intervertebral foramen. The probe includes electrodes on opposite surfaces. Threshold currents required to stimulate action potentials for each electrode are determined. A ratio of the threshold currents are calculated. Tissue is removed from the non-neural tissue structure when the ratio is greater than a predetermined threshold.

Claims

1. A method for locating neural tissue in a patient'"'"'s intervertebral foramen, so that the neural tissue can be avoided when decompressing the intervertebral foramen, the method comprising:

advancing a probe along a path within an intervertebral foramen, the probe having a first surface oriented anteriorly and towards neural tissue within the intervertebral foramen and a second surface oriented posteriorly and away from the neural tissue;

delivering a first electrical current to a first electrode along the first surface of the probe;

delivering a second electrical current to a second electrode along the second surface of the probe;

verifying that the neural tissue is anterior to the probe in the intervertebral foramen by monitoring neural response to the first and second electrical currents;

determining a first threshold amount of electrical current required to stimulate measurable action potentials in the neural tissue via the first electrode;

determining a second threshold amount of electrical current required to stimulate measurable action potentials in the neural tissue via the second electrode;

comparing the first and second threshold amounts of current to determine which of the first and second surfaces is closest to the neural tissue;

calculating a ratio of the threshold amount of current applied to the electrode farthest from the neural tissue compared to the threshold amount of current applied to the electrode closest to the neural tissue; and

removing tissue from the intervertebral foramen posterior to the path of the probe with a tissue modification device, to reduce impingement of the neural tissue when the ratio is greater than or equal to 2.

2. A method as in claim 1, wherein the probe comprises an elongate flattened body having an axis and a distal end, the first and second surfaces comprising opposed major surfaces of the elongate body.

3. A method as in claim 1, wherein advancing the probe comprises advancing a distal portion of the probe along an interface between a bone or ligament surface and a soft tissue surface.

4. A method as in claim 1, further comprising advancing a curved, shape-memory guide member having at least one lumen out of a distal opening on the probe device.

5. A method as in claim 1, further wherein the step of removing tissue from the intervertebral foramina comprises removing the tissue when the threshold amount of current applied to the electrode closest to the neural tissue is less than about 1 milliamp, and wherein the amount of threshold current applied to the electrode farthest from the neural tissue is greater than about 2 milliamps.

6. A method as in claim 1, wherein monitoring the neural response to the first and second currents comprises monitoring at least one of somatosensory evoked potentials (SSEP), motor evoked potentials (MEP), electromyography (EMG), visible muscle twitch and tactile muscle twitch.

7. The method of claim 1, further comprising shielding the neural tissue from the tissue modification device.

8. The method of claim 1, further wherein removing tissue from the intervertebral foramen comprises abrasively removing tissue.

16. The method of claim 1, wherein the step of advancing the probe comprises advancing the probe over a wire.

17. The method of claim 1, wherein the step of advancing the probe comprises pulling the probe within the intervertebral foramen with a wire.

9. A method for locating neural tissue in a patient'"'"'s intervertebral foramen, so that the neural tissue can be avoided when decompressing the intervertebral foramen, the method comprising:

advancing a probe along a path within an intervertebral foramen, the probe having a first surface oriented anteriorly and toward neural tissue within the intervertebral foramen and a second surface oriented posteriorly and away from the neural tissue;

delivering a first electrical current to a first electrode along the first surface of the probe;

delivering a second electrical current to a second electrode along the second surface of the probe;

maintaining orientation of the probe as it is advanced so that the first surface of the advanced probe remains oriented anteriorly and towards the neural tissue and the second surface remains oriented posteriorly and away from the neural tissue by monitoring neural response to the first and second electrical currents;

determining a first threshold amount of electrical current required to stimulate measurable action potentials in the neural tissue via the first electrode;

determining a second threshold amount of electrical current required to stimulate measurable action potentials in the neural tissue via the second electrode;

comparing the first and second threshold amounts of current to determine which of the first and second surfaces is closest to the neural tissue;

calculating a ratio of the threshold amount of current applied to the electrode farthest from the neural tissue compared to the threshold amount of current applied to the electrode closest to the neural tissue; and

cutting tissue from the intervertebral foramen posterior to the path of the probe with a tissue modification device to reduce impingement of the neural tissue in the intervertebral foramen when the ratio is greater than or equal to 2.

10. The method of claim 9, wherein the probe comprises an elongate flattened body having an axis and a distal end, the first and second surfaces comprising opposed major surfaces of the elongate body.

11. A method as in claim 9, wherein the probe is advanced along a tissue interface between two adjacent tissue planes, and advancing the probe causes the probe'"'"'s distal end to dissect the neural tissue from the other tissue along the tissue interface, the other tissue comprising an impinging tissue and being harder than the neural tissue.

12. A method for locating neural tissue in a patient'"'"'s intervertebral foramen, so that the neural tissue can be avoided when decompressing the intervertebral foramen, the method comprising:

advancing a probe along a path within an intervertebral foramen, the probe having a first surface oriented anteriorly and toward neural tissue within the intervertebral foramen and a second surface oriented posteriorly and away from the neural tissue;

delivering a first electrical current to a first electrode along the first surface of the probe;

delivering a second electrical current to a second electrode along the second surface of the probe;

maintaining orientation of the probe as it advances, so that the first surface of the advanced probe remains oriented anteriorly and towards the neural tissue and the second surface remains oriented posteriorly and away from the neural tissue, by monitoring neural response to the first and second electrical currents;

determining a first threshold amount of electrical current required to stimulate measurable action potentials in the neural tissue via the first electrode;

determining a second threshold amount of electrical current required to stimulate measurable action potentials in the neural tissue via the second electrode;

comparing the first and second threshold amounts of current to determine which of the first and second surfaces is closest to the neural tissue;

calculating a ratio of the threshold amount of current applied to the electrode farthest from the neural tissue compared to the threshold amount of current applied to the electrode closest to the neural tissue; and

abrasively removing tissue from the intervertebral foramen posterior to the path of the probe with a tissue modification device to reduce impingement of the neural tissue when the ratio is greater than or equal to 2.

13. The method of claim 12, further comprising shielding the neural tissue.

14. A method for locating neural tissue in a patient'"'"'s intervertebral foramen, so that the neural tissue can be avoided when decompressing the intervertebral foramen, the method comprising:

advancing a probe along a path within an intervertebral foramen, the probe having a first surface oriented anteriorly and towards neural tissue within the intervertebral foramen and a second surface oriented posteriorly and away from the neural tissue;

delivering a first electrical current to a first electrode along the first surface of the probe;

delivering a second electrical current to a second electrode along the second surface of the probe;

verifying that the neural tissue is anterior to the probe in the intervertebral foramen by monitoring neural response to the first and second electrical currents;

determining a first threshold amount of electrical current required to stimulate measurable action potentials in the neural tissue via the first electrode;

determining a second threshold amount of electrical current required to stimulate measurable action potentials in the neural tissue via the second electrode;

comparing the first and second threshold amounts of current, to determine which of the first and second surfaces is closest to the neural tissue;

calculating a ratio of the threshold amount of current applied to the electrode farthest from the neural tissue compared to the threshold amount of current applied to the electrode closest to the neural tissue, and

removing tissue from the intervertebral foramen posterior to the path of the probe with a tissue modification device to reduce impingement of the neural tissue when the ratio is greater than or equal to about 2.

15. A method for locating neural tissue in a patient'"'"'s intervertebral foramen, so that the neural tissue can be avoided when decompressing the intervertebral foramen, the method comprising:

advancing a probe along a path within an intervertebral foramen, the probe having a first surface oriented towards neural tissue within the intervertebral foramen and a second surface oriented away from the neural tissue;

delivering a first electrical current to a first electrode along the first surface of the probe;

delivering a second electrical current to a second electrode along the second surface of the probe;

determining a first threshold amount of electrical current required to stimulate measurable action potentials in the neural tissue via the first electrode;

determining a second threshold amount of electrical current required to stimulate measurable action potentials in the neural tissue via the second electrode;

comparing the first and second threshold amounts of current, to determine which of the first and second surfaces is closest to the neural tissue;

calculating a ratio of the threshold amount of current applied to the electrode farthest from the neural tissue compared to the threshold amount of current applied to the electrode closest to the neural tissue, and

removing tissue from the intervertebral foramen adjacent to the path of the second surface of the probe when the ratio is greater than or equal to about 2.