Flexible neural localization devices and methods

• US 8,801,626 B2
• Filed: 12/29/2011
• Issued: 08/12/2014
• Est. Priority Date: 10/15/2004
• Status: Active Grant

• Current Assignee: Mis Ip Holdings LLC, Spinal Elements, Inc.
• Original Assignee: Baxano Surgical, Inc.
• Inventors: Sun, Benjamin Kao-Shing, Wallace, Michael P., Summa, Christopher D., Bleich, Jeffery L.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Pani, John
• Application Number:
  US13/340,363
• Publication Number:
  US 20120123294A1
• Time in Patent Office: 957 Days
• Field of Search: 600544-547, 600/554, 607115-118
• US Class Current: 600/554
• CPC Class Codes: A61B 17/149 Chain, wire or band saws
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/7092 for checking pedicle hole has correct depth or has an intact wall pedicle drill depth limiters A61B17/1626
• CPC Class Codes: A61B 17/8897 Guide wires or guide pins
• CPC Class Codes: A61B 2562/0261 Strain gauges
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4519 Muscles A61B5/389, A61B5/224 take precedence
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6855 with a distal curved tip
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy

Abstract

Methods for determining if a nerve is nearby a device. The neural stimulation tools described herein are configured to be flexible and low-profile, so that they can be used within body regions that may be tortuous or difficult to reach, such as within a compressed or partially occluded neural foramen. In most cases, these tools described herein are ribbon-shaped and adapted to be manipulated bimanually, applying force to the ends of the devices from separate locations outside of the patient'"'"'s body. Thus, the distal end region of the device may be configured to couple to the proximal end of a guidewire. One or more surfaces of the devices may include an electrode or multi-polar network of electrodes configured to stimulate only nerves within a predetermined distance of a particular face of the device. Methods of using these devices are described.

Claims

1. A method of positioning a neural localization device to determine if a nerve is nearby, the method comprising:

passing a neural localization device along a first pathway, the neural localization device having a flexible ribbon-shaped body having a first set of electrodes on one face of the ribbon-shaped body and a second set of electrodes on an opposite face of the ribbon-shaped body;

energizing a first stimulation region of the neural localization device to emit a stimulation field in a first stimulation direction from the neural localization device;

determining a threshold stimulation location along the pathway, wherein the threshold stimulation location corresponds to a position along the pathway having the lowest stimulation level emitted in the first stimulation direction that evokes a response from a target neural tissue;

positioning the neural localization device at the threshold stimulation location;

determining a threshold stimulation level in a second stimulation direction from the neural localization device while the neural localization device is at the threshold stimulation location; and

comparing the stimulation level emitted in the first stimulation direction at the threshold stimulation location to the threshold stimulation level in the second stimulation direction to determine if the target neural tissue is in the first stimulation direction or in the second stimulation direction.

2. The method of claim 1, further comprising coupling the neural localization device to a guidewire.

3. The method of claim 1, wherein passing the neural localization device along the first pathway comprises passing a guidewire along the first pathway before passing the neural localization device.

4. The method of claim 1, wherein energizing the first stimulation region comprises applying stimulation by ramping a current from 0 mA to less than 100 mA.

5. The method of claim 1, wherein energizing the first stimulation region comprises repeatedly ramping a current between 0 mA and less than 100 mA.

6. The method of claim 1, wherein determining a threshold stimulation location along the pathway comprises moving the neural localization device forward and backward along the pathway while emitting the stimulation field in the first stimulation direction.

7. The method of claim 1, wherein determining a threshold stimulation location along the pathway comprises determining the minimum stimulation emitted in the first stimulation direction that evokes a response from a target neural tissue.

8. The method of claim 1, wherein determining the threshold stimulation level in the second stimulation direction from the neural localization device comprises increasing the current applied from the second stimulation direction until a response is detected.

9. The method of claim 1, wherein comparing the stimulation level emitted in the first stimulation direction to the threshold stimulation level in the second stimulation direction comprises comparing the minimum stimulation level required to evoke a response that is emitted in the first stimulation direction at the threshold stimulation direction to the threshold stimulation level emitted in the second stimulation direction.

10. A method of positioning a neural localization device to determine a location of a nerve relative to a device, the method comprising:

passing a distal end of a neural localization device in a first direction;

energizing a first stimulation region of the neural localization device to emit a stimulation field in a first stimulation direction from the neural localization device and evoking a response from a target neural tissue, wherein emitting the stimulation field includes ramping a current between a plurality of stimulation levels;

determining, at a first location, a minimum stimulation level that evokes the response from the target neural tissue from the first stimulation region;

energizing a second stimulation region of the neural localization device to emit a stimulation field in a second stimulation direction from the neural localization device while the neural localization device is in the first location;

determining, at the first location, a minimum stimulation level that evokes a response from the target neural tissue from the second stimulation region;

comparing the minimum stimulation level from the first stimulation region to the minimum stimulation level from the second stimulation region to determine if the target neural tissue is in the first stimulation direction or in the second stimulation direction;

moving the first stimulation region and the second stimulation region in the first stimulation direction to a second location;

energizing the first stimulation region at the second location to determine a second minimum stimulation level that evokes a response from the target neural tissue from the first stimulation region;

energizing the second stimulation region at the second location to determine a second minimum stimulation level that evokes a response from the target neural tissue from the second stimulation region; and

comparing the second minimum stimulation level from the first stimulation region to the second minimum stimulation level from the second stimulation region to determine if the target neural tissue is in the first stimulation direction or in the second stimulation direction.

11. The method of claim 10, wherein the first stimulation region and the second stimulation region are moved in the first stimulation direction to a second location when a ratio of the minimum stimulation level from the first stimulation region to the minimum stimulation level from the second stimulation region is within a predetermined range.

12. The method of claim 10, wherein the first stimulation region and the second stimulation region are moved in the first stimulation direction to a second location when the step of comparing the minimum stimulation level from the first stimulation region to the minimum stimulation level from the second stimulation region to determine if the target neural tissue is in the first stimulation direction or in the second stimulation direction is inconclusive.