Method, system and apparatus for neural localization

• US 8,303,516 B2
• Filed: 04/20/2011
• Issued: 11/06/2012
• Est. Priority Date: 09/06/2007
• Status: Active Grant

• Current Assignee: Spinal Elements, Inc.
• Original Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Inventors: Schmitz, Gregory P., Wallace, Michael P., Bleich, Jeffery L., Miller, Eric C.
• Primary Examiner(s): TOWA, RENE T
• Application Number:
  US13/090,944
• Publication Number:
  US 20110196257A1
• Time in Patent Office: 566 Days
• Field of Search: 600/372, 600/377, 600/393, 600/547, 600/554, 600/587, 607/46, 607/48, 607115-118, 607/148
• US Class Current: 600/554
• 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 5/1104 induced by stimuli or drugs; A61B5/1102 takes precedence; investigating medicinal preparations G01N33/15
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/4504 Bones A61B5/4547 takes precedence
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/6855 with a distal curved tip

Abstract

Described herein are devices, systems and methods for determining if a nerve is nearby a device or a region of a device. In general, a device for determining if a nerve is nearby a device includes an elongate body having an outer surface with one or more bipole pairs arranged on the outer surface. Bipole pairs may also be referred to as tight bipoles. The bipole pairs may be arranged as a bipole network, and may include a cathode and an anode that are spaced relatively close together to form a limited broadcast field. In general, the broadcast filed is a controlled or “tight” broadcast field that extends from the bipole pair(s). Methods of using these devices and system are also described.

Claims

1. A method of detecting if a nerve is above or below a region of a device in a tissue, the method comprising:

positioning a device within the tissue, wherein the device comprises a flexible elongate body having an upper region that is opposite from a lower region, and a first plurality of anodes and cathodes on the upper region and a second plurality of anodes and cathodes on the lower region;

determining a threshold amount of energy required to stimulate a response in the patient from the upper region by applying increasing levels of energy to form a substantially continuous broadcast field in the upper region to determine the first stimulation level at which the nerve responds;

determining a threshold amount of energy required to stimulate a response in the patient from the lower region by applying increasing levels of energy to form a substantially continuous broadcast field in the lower region to determine the first stimulation level at which the nerve responds;

determining if the nerve is above the device or below the device, wherein the nerve is above the device when the nerve is closer to the upper region, by comparing the threshold amounts; and

positioning a guidewire within the tissue based on the thresholds determined from the upper and lower regions.

2. A method of detecting if a nerve is above or below a region of a device in a tissue, the method comprising:

positioning a device within the tissue, wherein the device comprises a flexible elongate body having an upper region and a lower region, wherein the upper region faces the dorsal side of a patient and the lower region faces the ventral side of the patient;

determining a threshold amount of energy required to stimulate a response in the patient from the upper region by applying increasing levels of energy from the upper region to determine the first stimulation level at which the nerve responds;

determining a threshold amount of energy required to stimulate a response in the patient from the lower region by applying increasing levels of energy from lower region to determine the first stimulation level at which the nerve responds;

confirming that the nerve is ventral to the device, wherein the nerve is closer to the lower region, by comparing the threshold amounts.

3. The method of claim 2, further comprising positioning a guidewire after confirming that the nerve is ventral to the device.

4. The method of claim 3, further comprising removing the device from the patient with the guidewire in position.

5. The method of claim 4, further comprising using the guidewire to position a surgical device.

6. The method of claim 2, wherein the determining step comprises applying increasing levels of energy from at least one electrode on the elongate body.

7. The method of claim 6, further comprising the step of rotating the at least one electrode on the elongate body from the upper region of the device to the lower region of the device.

8. The method of claim 2, wherein the determining step comprises applying increasing levels of energy from at least one anode and cathode pair on the upper region of the elongate body.

9. The method of claim 8, wherein the second determining step comprises applying increasing levels of energy from at least one anode and cathode pair on the lower region of the elongate body.

10. A method of detecting if a nerve is above or below a region of a device in a tissue, the method comprising:

positioning a device within the tissue, wherein the device comprises a flexible elongate body having an upper region that is opposite from a lower region, and a first plurality of anodes and cathodes on the upper region and a second plurality of anodes and cathodes on the lower region;

determining a threshold amount of energy required to stimulate a response in the patient from the upper region by applying increasing levels of energy to form a substantially continuous broadcast field in the upper region to determine the first stimulation level at which the nerve responds;

determining a threshold amount of energy required to stimulate a response in the patient from the lower region by applying increasing levels of energy to form a substantially continuous broadcast field in the lower region to determine the first stimulation level at which the nerve responds; and

determining if the nerve is above the device or below the device, wherein the nerve is above the device when the nerve is closer to the upper region, by comparing the threshold amounts.

11. The method of claim 10, further comprising positioning a guidewire after confirming that the nerve is ventral to the device.

12. The method of claim 11, further comprising removing the device from the patient with the guidewire in position.

13. The method of claim 12, further comprising using the guidewire to position a surgical device.