Neurophysiologic monitoring system

• US 9,295,396 B2
• Filed: 08/28/2012
• Issued: 03/29/2016
• Est. Priority Date: 04/03/2007
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Gharib, James, Farquhar, Allen, Layman, Doug, Scholl, Thomas, Kim, Albert, Pothier, Albert, Miles, Patrick, Gorek, Josef, Peterson, Mark
• Primary Examiner(s): DOUGHERTY, SEAN PATRICK
• Application Number:
  US13/597,160
• Publication Number:
  US 20130090568A1
• Time in Patent Office: 1,309 Days
• Field of Search: 600/372, 600/373, 600/546, 600/547, 600/554, 606/116, 606/117
• US Class Current: 1/1
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• 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 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/407 Evaluating the spinal cord A61B5/4896 takes precedence
• CPC Class Codes: A61B 5/4566 Evaluating the spine A61B5/4561 takes precedence
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/7271 Specific aspects of physiological measurement analysis A61B5/316, A61B5/349 and A61B5/374 take precedence
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

The present invention relates to a system and methods generally aimed at surgery. More particularly, the present invention is directed at a system and related methods for performing surgical procedures and assessments involving the use of neurophysiology.

Claims

1. A system for avoiding harm to neural tissue during surgery, comprising:

an instrument capable of advancement to a surgical target site and configured to deliver a stimulation signal at least one of while advancing to said target site and after reaching said target site; and

a processing system in communication with said instrument and programmed to perform a plurality of neurophysiologic testing functions including at least two of static pedicle integrity testing, dynamic pedicle integrity testing, nerve proximity detection, neuromuscular pathway assessment, manual motor evoked potential monitoring, automatic motor evoked potential monitoring, somatosensory evoked potential monitoring, non-evoked monitoring, and surgical navigation;

said processing system programmed with a plurality of pre-established testing profiles corresponding to one or more of a specific surgical procedure and a specific spinal region being operated upon;

wherein selection of a pre-established profile dictates which of the neurophysiologic testing functions are available for selection and sets specific test parameters associated with the available neurophysiologic testing functions so as to facilitate the initiation of said at least one neurophysiologic testing function;

said processing system further programmed with a set of at least three threshold ranges and configured to direct a first stimulation signal to said instrument at a first magnitude corresponding to a boundary between a pair of said ranges, direct a second stimulation signal at a second magnitude corresponding to a boundary between a different pair of said ranges, and to measure at least one response of nerves depolarized stimulation signals by said stimulation signals to indicate at least one of nerve proximity and pedicle integrity.

2. The system of claim 1, wherein said pre-established profile is at least one of pre-programmed by a manufacturer of said system and saved by a user after creating said profile.

3. The system of claim 1, wherein said specific surgical procedures are comprised of ACDF, XLIF, and decompression surgical procedures.

4. The system of claim 1, wherein said specific spinal regions are comprised of cervical, thoracolumbar, and lumbar.

5. The system of claim 1, wherein said specific test parameters are comprised of electrode placement, myotomes monitored, and stimulation signal parameters.

6. The system of claim 5, wherein the at least one evoked response is measured by monitoring neuromuscular waveforms of myotomes associated with said depolarized nerves.

7. The system of claim 1, wherein the at least one evoked response is an EMG response.

8. The system of claim 1, wherein said system includes a display for communicating said at least one of nerve proximity and pedicle integrity.

9. The system of claim 8, wherein said system indicates at least one of nerve proximity and pedicle integrity by displaying at least one of the colors red, yellow, and green.

10. The system of claim 9, wherein said processing system automatically determines a stimulation threshold after displaying said one of red, yellow, and green.

11. The system of claim 10, wherein said processing system augments the display of said one of red, yellow, and green with a numerical value after determining said threshold.

12. The system of claim 1, wherein said instrument is a device for forming a hole in a pedicle.

13. The system of claim 1, wherein said instrument is part of a system for establishing an operative corridor to a surgical target site.

14. The system of claim 13, wherein said operative corridor is a lateral approach to a spinal target site.

15. The system of claim 1, comprising a plurality of sensors for measuring said nerve responses.

16. The system of claim 15, wherein said plurality of sensors comprises at least one of an anode and a common electrode.

17. The system of claim 16, wherein said plurality of sensors connect to said processing system through a single connector.

18. The system of claim 17, wherein said single connector comprises an identifier that is recognized by said processing unit.

19. The system of claim 18, wherein the identification of said connector alters system parameters employed by said processing system.