System and methods for performing surgical procedures and assessments

• US 8,027,716 B2
• Filed: 04/20/2009
• Issued: 09/27/2011
• Est. Priority Date: 09/25/2001
• Status: Expired due to Term

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Martinelli, Scot, Finley, Eric, Elbanna, Jamil, Blewett, Jeffrey, Kaula, Norbert, Gharib, James, Farquhar, Allen
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Foreman; Jonathan M
• Application Number:
  US12/426,792
• Publication Number:
  US 20090204016A1
• Time in Patent Office: 890 Days
• Field of Search: 600/546, 600/554, 606/32, 606/53, 606/191, 607/117
• US Class Current: 600/546
• CPC Class Codes: A61B 1/32 Devices for opening or enlarging the visual field, e.g. of a tube of the body dilators A61M29/00
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/0262 with a provision for protecting nerves
• CPC Class Codes: A61B 2034/2053 Tracking an applied voltage gradient
• CPC Class Codes: A61B 2034/2072 Reference field transducer attached to an instrument or patient
• 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 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/388 Nerve conduction study, e.g. detecting action potential of peripheral nerves
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/6828 Leg
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: A61B 90/36 Image-producing devices or illumination devices not otherwise provided for
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/4611 : of spinal prostheses
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61N 1/0551 : Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 : Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/36142 : for improving safety
• CPC Class Codes: A61N 1/37247 : User interfaces, e.g. input or presentation means

Abstract

The present invention involves systems and related methods for performing surgical procedures and assessments, including the use of neurophysiology-based monitoring to: (a) determine nerve proximity and nerve direction to surgical instruments employed in accessing a surgical target site; (b) assess the pathology (health or status) of a nerve or nerve root before, during, or after a surgical procedure; and/or (c) assess pedicle integrity before, during or after pedicle screw placement, all in an automated, easy to use, and easy to interpret fashion so as to provide a surgeon-driven system.

Claims

1. A surgical system for neural monitoring while forming an operative corridor in a trans-psoas approach to a spine, comprising:

a control unit configured to receive user input regarding delivery of a stimulation signal to a stimulation electrode and to display on a color display device neuromuscular response data detected in response to the stimulation signal;

a connector module that provides a plurality of EMG response channels and an electrical connection for at least one surgical access instrument, the connector module having a wire connection to the control unit so that the connector module is positionable apart from the control unit;

a plurality of EMG electrodes connectable to the plurality of EMG response channels of the connector module, the EMG electrodes mountable relative to selected muscles;

a sequential dilation access system comprising a plurality of dilating cannulas to form a trans-psoas corridor between a skin surface and a targeted spine site, at least one of the dilating cannulas fitting over another of the dilating cannulas when advanced in a trans-psoas path toward the targeted spine site; and

a stimulation element electrically connectable to the connector module to deliver the stimulation signal proximate to a distal end of at least one of the dilating cannulas when advanced in the trans-psoas path toward the targeted spine site.

2. The surgical system of claim 1, wherein the sequential dilation access system comprises at least a first dilating cannula, a second dilating cannula that is slidable over the first dilating cannula.

3. The surgical system of claim 2, further comprising a working corridor instrument that is slidable over the second dilating instrument to form a trans-psaos operative corridor to the targeted spine site.

4. The surgical system of claim 3, wherein the stimulation element is an electrode arranged on the distal end of at least one of the dilating cannulas.

5. The surgical system of claim 4, wherein the stimulation electrode is positioned on one of the dilating cannulas to deliver the stimulation signal proximate to the distal end of the dilating cannula when advanced in the trans-psoas path, the stimulation electrode being arranged in a fixed position relative to a longitudinal axis of the dilating cannula such that the stimulation electrode rotates with the dilating cannula when the dilating cannula is rotated about the longitudinal axis while maintained in a fixed axial position.

6. The surgical system of claim 4, wherein each of the dilating cannulas in the sequential dilation access system comprises a corresponding stimulation electrode arranged on a distal end the dilating cannula.

7. The system of claim 1, wherein the color display device of the control unit comprises a touchscreen device to receive the user input regarding delivery of a stimulation signal.

8. A surgical system for neural monitoring while forming an operative corridor in a trans-psoas approach to a spine, comprising:

a control unit configured to receive user input regarding delivery of a stimulation signal to a stimulation electrode and to display on a color display device neuromuscular response data detected in response to the stimulation signal;

a sequential dilation access system comprising a plurality of dilating cannulas to form a trans-psoas corridor between a skin surface and a targeted spine site, at least one of the dilating cannulas fitting over another of the dilating cannulas when advanced in a trans-psoas path toward the targeted spine site,

wherein the stimulation electrode is positioned on one of the dilating cannulas to deliver the stimulation signal proximate to a distal end of the dilating cannula when advanced in the trans-psoas path, the stimulation electrode being arranged in a fixed position relative to a longitudinal axis of the dilating cannula such that the stimulation electrode rotates with the dilating cannula when the dilating cannula is rotated about the longitudinal axis.

9. The surgical system of claim 8, wherein the sequential dilation access system comprises at least a first dilating cannula, a second dilating cannula that is slidable over the first dilating cannula.

10. The surgical system of claim 9, further comprising a working corridor instrument that is slidable over the second dilating instrument to form a trans-psaos operative corridor to the targeted spine site.

11. The surgical system of claim 10, wherein the trans-psoas operative corridor to the spine is formed after the first and second dilating cannulas are removed from the working corridor instrument.

12. The surgical system of claim 8, further comprising:

a connector module that provides EMG response channels and an electrical connection for at least one surgical access instrument, the connector module having a wire connection to the control unit; and

a plurality of EMG electrodes connectable to the EMG response channels of the connector module, the EMG electrodes mountable relative to selected muscles.

13. The system of claim 8, wherein the color display device of the control unit comprises a touchscreen device to receive the user input regarding delivery of a stimulation signal.

14. The system of claim 8, wherein the stimulation signal delivered by the stimulation electrode is positioned on one of the dilating cannulas comprises stimulation current pulses, and the neuromuscular response data displayed by the control unit comprises a numeric stimulation threshold current level that indicates an amplitude of the stimulation current pulses required to evoke an EMG response having an amplitude value greater than a predetermined voltage value.

15. The method of claim 14, wherein the stimulation current pulses of the signal delivered by the stimulation electrode is positioned on one of the dilating cannulas comprises rectangular monophasic current pulses output from the stimulation electrode during formation of the trans-psoas corridor between the skin surface and the targeted spine site.