FLEXIBLE NEURAL LOCALIZATION DEVICES AND METHODS
First Claim
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;
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 while passing the neural localization device;
determining a threshold stimulation location along the pathway, wherein the threshold stimulation location corresponds to the 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.
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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.
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Citations
26 Claims
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1. A method of positioning a neural localization device to determine if a nerve is nearby, the method comprising:
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passing a neural localization device along a first pathway; 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 while passing the neural localization device; determining a threshold stimulation location along the pathway, wherein the threshold stimulation location corresponds to the 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. - View Dependent Claims (2, 3, 5, 6, 7, 8, 9, 11, 13, 15)
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4. (canceled)
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10. (canceled)
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12. (canceled)
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14. (canceled)
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16. (canceled)
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17. A method of positioning a neural localization device, the method comprising:
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passing a distal tip of a guidewire into a patient, around a target tissue adjacent to a neural tissue, and out of the patient so that proximal and distal ends of the guidewire extend from the patient; coupling the distal end of a neural localization device to the proximal end region of the guidewire; pulling the neural localization device into the patient using the guidewire to pass the neural tissue; emitting a stimulation field in a first direction from the neural localization device while passing the neural localization device near the neural tissue; determining, at a plurality of locations, a minimum stimulation level that evokes a response from the neural tissue when emitting a stimulation field in the first direction while passing the neural localization device near the neural tissue; and positioning the neural localization device at a location where a lowest minimum stimulation level was determined. - View Dependent Claims (18, 19, 20, 21, 23, 24, 25)
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22. (canceled)
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26. A method of positioning a neural localization device to determine a location of a nerve relative to a device, the method comprising:
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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 while passing the neural localization device in the first direction, wherein the stimulation field includes a plurality of stimulation levels; determining, at a plurality of locations, a minimum stimulation level that evokes a response from the target neural tissue while passing the neural localization device in the first direction; positioning the neural localization device in the location where the lowest minimum stimulation level was determined; 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 location where the lowest minimum stimulation level was determined; determining a minimum stimulation level that evokes a response from the target neural tissue from the second stimulation region; and comparing the lowest 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.
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Specification