Neurophysiologic monitoring system

Patent metadata

Field	Value
Publication number	US-9295396-B2
Application number	US-201213597160-A
Country	US
Kind code	B2
Filing date	Aug 28, 2012
Priority date	Apr 3, 2007
Publication date	Mar 29, 2016
Grant date	Mar 29, 2016

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.

First claim

The invention claimed is:

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.

Assignees

• Gharib James
• Farquhar Allen
• Layman Doug
• Scholl Thomas
• Kim Albert
• Pothier Albert
• Miles Patrick
• Gorek Josef
• Peterson Mark
• Nuvasive Inc

Inventors

• Gharib James
• Farquhar Allen
• Layman Doug
• Scholl Thomas
• Kim Albert
• Pothier Albert
• Miles Patrick
• Gorek Josef
• Peterson Mark

Classifications

• A61B2017/00026

  Conductivity or impedance, e.g. of tissue · CPC title

• A61B17/1626

  Control means; Display units · CPC title

• A61B17/1671 Primary

  for the spine · CPC title

• A61B5/7271

  Specific aspects of physiological measurement analysis (specific diagnostics methods using bioelectric or biomagnetic signals A61B5/316) · CPC title

• A61B5/05

  Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves (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 title