System and methods for assessing the neuromuscular pathway prior to nerve testing

• US 8,538,539 B2
• Filed: 10/07/2005
• Issued: 09/17/2013
• Est. Priority Date: 10/07/2004
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: NU Vasive Incorporated
• Inventors: Gharib, James, Farquhar, Allen, Howell, Kelli, Layman, Doug, Pothier, Albert
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): EDWARDS, PHILIP CHARLES
• Application Number:
  US11/665,038
• Publication Number:
  US 20090018610A1
• Time in Patent Office: 2,902 Days
• Field of Search: 607/48
• US Class Current: 607/48
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/17 Guides or aligning means for drills , mills, pins or wires
• CPC Class Codes: A61B 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/1106 to assess neuromuscular blockade, e.g. to estimate depth of anaesthesia
• 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 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]

Abstract

The present invention involves a system and methods for assessing the state of the neuromuscular pathway to ensure further nerve tests aimed at detecting at least one of a breach in a pedicle wall, nerve proximity, nerve direction, and nerve pathology, are not conducted when neuromuscular blockade levels may decrease the reliability of the results.

Claims

1. A surgeon-directed surgical system, comprising:

an accessory configured to transmit a stimulation signal to a nerve forming part of a neuromuscular pathway including a muscle myotome associated with the nerve;

a sensor configured to detect evoked responses from the muscle myotome; and

a control unit coupled to the accessory and the sensor, the control unit being operable to (a) control under the direction of a surgeon the accessory to transmit stimulation signals, (b) monitor the evoked responses from the sensor, and (c) assess the neuromuscular pathway by identifying a relationship between at least two evoked responses, wherein the relationship provides an indication as to a level of neuromuscular blockade within a patient'"'"'s body.

2. The surgical system of claim 1, wherein the relationship identified is the ratio between the magnitude of a first evoked response and a second evoked response.

3. The surgical system of claim 1, wherein the relationship identified is at least one of the presence and absence of the second evoked response.

4. The surgical system of claim 2, wherein the sensor is configured to detect an EMG voltage output of the muscle myotome and the control unit determines the magnitude of said EMG voltage output to characterize the evoked response.

5. The surgical system of claim 4, wherein the magnitude of the voltage output is characterized by a peak-to-peak amplitude.

6. The surgical system of claim 4, wherein the relationship identified is the ratio of the amplitude of the second evoked response versus the amplitude of the first evoked response.

7. The surgical system of claim 4, wherein the stimulation signal comprises four electric current pulses of equal magnitude and the relationship is the amplitude ratio of a fourth evoked response versus the amplitude of a first response.

8. The surgical system of claim 1, wherein the system assesses the neuromuscular pathway prior to a nerve testing during at least one of cervical, thoracic and lumbar spine surgery.

9. The surgical system of claim 8, wherein the nerve testing includes at least one of pedicle integrity testing, nerve detection during surgical access, and nerve root retraction.

10. The surgical system of claim 9, wherein the pedicle integrity testing includes at least one of static pedicle integrity testing and dynamic pedicle integrity testing.

11. The system of claim 10, wherein said accessory includes at least one of a probe, a K-wire, a tap, and an awl.

12. The surgical system of claim 10, wherein the control unit is further configured to display at least one of a numerical value and a color representing the integrity of the pedicle as the result of pedicle integrity testing.

13. The surgical system of claim 10, wherein the control unit is further configured to emit an audible sound representing the integrity of the pedicle as the result of the pedicle integrity testing.

14. The surgical system of claim 10, wherein the control unit is further configured to display electromyographic waveforms of at least one of spontaneous responses of the muscle myotome and the evoked responses of the muscle myotome.

15. The surgical system of claim 14, wherein the control unit is configured to display the electromyographic waveforms of at least one of the spontaneous responses of the muscle myotome and the evoked response of the muscle myotome in addition to at least one of a numerical value and a color representing the integrity of the pedicle as the result of pedicle integrity testing.

16. The surgical system of claim 9, wherein the control unit is configured to display a menu of options including at least one of neuromuscular pathway testing, pedicle integrity testing, nerve detection during surgical access, and nerve retraction.

17. The surgical system of claim 16, wherein the menu of options is operated via a touch-screen display in communication with and under the direction of the control unit.

18. The surgical system of claim 17, wherein each of the neuromuscular pathway testing, pedicle integrity testing, nerve detection during surgical access, and nerve root retraction option on the menu of options are selectable to additionally display the electromyographic waveforms of at least one of spontaneous responses of the muscle myotome and the evoked responses of the muscle myotome.

19. The surgical system of claim 1, wherein the control unit is configured to display a set up screen capable of being operated to adjust at least one of system volume, the volume associated with spontaneous muscle myotome response, the scale of the evoked response, and the level of the stimulation signal.

20. The surgical system of claim 1, wherein the control unit is configured to perform an impedance test prior to at least one of the neuromuscular pathway testing and nerve testing, wherein the nerve testing includes at least one of pedicle integrity testing, nerve detection during surgical access, and nerve root retraction.

21. The surgical system of claim 1, wherein the system assesses the neuromuscular pathway by applying the stimulation signal at least one of on or near the nerve.

22. The surgical system of claim 1, wherein the system assesses the neuromuscular pathway by applying the stimulation signal to electrodes adapted to be placed over a peripheral nerve.

23. The surgical system of claim 22, wherein the peripheral nerve is the peroneal nerve.

24. The surgical system of claim 1, wherein the stimulation signal includes at least two current pulses, each having a pulse duration and a delivery frequency.

25. The surgical system of claim 24, wherein the pulse duration is the range from 100 to 500 microseconds.

26. The surgical system of claim 24, wherein the pulse duration is approximately 200 microseconds.

27. The surgical system of claim 24, wherein the delivery frequency of each pulse is in the range from 0.5 Hz to 5 Hz.

28. The surgical system of claim 24, wherein the amplitude of the current pulses is determined by assessing the threshold current required to obtain an evoked response.

29. The surgical system of claim 1, wherein the system assesses the neuromuscular pathway via an assessment that includes establishing a baseline current prior to the administration of a neuromuscular blocking agent.

30. The surgical system of claim 24, wherein the stimulation signal includes four current pulses.

31. The surgical system of claim 1, wherein the stimulation signal may be applied at least one of automatically and manually.

32. The surgical system of claim 31, wherein the control unit is configured to display a selection such that the surgeon may choose between at least one of automatic stimulation signal selection and manual stimulation signal selection.

33. The surgical system of claim 1, wherein the control unit is further configured to display at least one of alpha-numeric or graphical information regarding at least one of the stimulation signal, the neuromuscular responses, and the status of the neuromuscular pathway.

34. The surgical system of claim 1, wherein the sensor is configured to detect changes in pressure and the magnitude of the evoke responses is characterized by the measured pressure change.

35. The surgical system of claim 1, wherein the stimulation signal comprises four electrical current pulses of equal amplitude resulting in four corresponding evoked responses and the relationship identified is the ratio of the peak-to-peak amplitude of the fourth evoked response relative to the peak-to-peak amplitude of the first evoked response.

36. The surgical system of claim 1, wherein the stimulation signal comprises one electrical current pulse and the control unit calculates the ratio of the peak-to-peak amplitude of a first evoked response relative peak-to-peak amplitude of a predetermined baseline response.

37. The surgical system of claim 35, wherein the control unit is further configured to display at least one of a numerical value representing the amplitude ratio and a bar graph representing the relative amplitude for all four evoked responses.

38. The surgical system of claim 10, wherein the pedicle integrity testing is performed by increasing the stimulation signal until a lowest evoked response is detected by the sensor, at which time the stimulation signal is stopped.

39. The surgical system of claim 10, wherein the pedicle integrity testing is performed by increasing the stimulation signal until a highest evoked response is detected by the sensor, at which time the stimulation signal is stopped.

40. The surgical system of claim 1, wherein the control is configured to allow a surgeon to create and annotate a record of events of a surgical procedure, including capturing at least one of the time the stimulation signal was applied, the location where the stimulation signal was applied, and the type of nerve testing performed by the application of the stimulation signal.

41. The surgical system of claim 40, wherein the control unit creates a record of the errors detected by the control unit during operation.

42. The surgical system of claim 1, wherein the control unit is configured to create a report capturing information regarding a surgical procedure, including at least one of surgeon name, patient identification, surgical level in the spine, number of nerves tested, duration of intraoperative neurophysiology testing, the parameters and results of neuromuscular pathway testing, the parameters and results of spontaneous electromyographic muscle responses, the parameters and results of evoked responses during nerve detection during surgical access, the parameters and results of evoked responses during pedicle integrity testing, the parameters and results of evoked responses during nerve pathology assessment.

43. The surgical system of claim 42, wherein the report is at least one of a full report and a summary report, wherein the full report sets forth in chronological order the parameters and results gathered for each testing occurrence during the surgical procedure, and wherein the summary report sets forth in grouping each type of event along with the results and parameters of that grouping of events.

44. The surgical system of claim 9, wherein the nerve detection during surgical access may be performed during at least one of the steps of distraction and retraction to establish an operative corridor.

45. The surgical system of claim 44, wherein the accessory includes at least one of a K-wire, an initial dilator, and a multi-blade retractor.

46. The surgical system of claim 44, wherein the control unit is further configured to display at least one of a numerical value and a color representing parameters of the nerve detection during surgical access.

47. The surgical system of claim 44, wherein the control unit is further configured to emit an audible sound in response to the nerve detection during surgical access.

48. The surgical system of claim 44, wherein the control unit is further configured to display electromyographic waveforms of at least one of spontaneous responses of the muscle myotome and the evoked responses of the muscle myotome.

49. The surgical system of claim 48, wherein the control unit is configured to display the electromyographic waveforms of at least one of the spontaneous responses of the muscle myotome and the evoked responses of the muscle myotome in addition to at least one of a numerical value and a color representing parameters of the nerve detection during surgical access.

50. The surgical system of claim 9, wherein the nerve root retraction may be performed at least one of before, during, and after a spinal surgical procedure.

51. The surgical system of claim 50, wherein said accessory includes a nerve root retractor having at least one electrode for delivering the stimulation signal to the nerve.

52. The surgical system of claim 50, wherein the control unit is further configured to display at least one of a numerical value and a color representing parameters of the nerve root retraction.

53. The surgical system of claim 50, wherein the control unit is further configured to emit an audible sound in response to the nerve root retraction.

54. The surgical system of claim 50, wherein the control unit is further configured to display electromyographic waveforms of at least one of spontaneous responses of the muscle myotome and the evoked responses of the muscle myotome.

55. The surgical system of claim 54, wherein the control unit is configured to display the electromyographic waveforms of at least one of the spontaneous responses of the muscle myotome and the evoked responses of the muscle myotome in addition to at least one of a numerical value and a color representing parameters of the nerve root retraction.