System and methods for performing surgical procedures and assessments

• US 20050075578A1
• Filed: 03/25/2004
• Published: 04/07/2005
• Est. Priority Date: 09/25/2001
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Martinelli, Scot, Finley, Eric, Elbanna, Jamil, Kaula, Norbert, Gharib, James, Blewett, Jeffrey J., Farquhar, Allen, Medeiros, Goretti
• Granted Patent: US 7,522,953 B2
• Time in Patent Office: Days
• 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 5/24 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 5/4893 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 system for performing surgical procedures and assessments, comprising:

a surgical accessory having at least one stimulation electrode; and

a processing system having at least one of computer programming software, firmware and hardware capable of stimulating said at least one stimulation electrode on a surgical accessory, measuring the response of nerves depolarized by said stimulation, determining a relationship between the surgical accessory and the nerve based upon the response measured, and communicating said relationship to a user, wherein said relationship may be used to determine at least one of nerve proximity, nerve direction, pedicle integrity, and neural pathology.

2. The system set forth in claim 1 and further, wherein the response of said depolarized nerves is measured by monitoring the EMG waveforms of myotomes associated with said depolarized nerves.

3. The system set forth in claim 2 and further, wherein said surgical accessory comprises a system for establishing an operative corridor to a surgical target site.

4. The system set forth in claim 3 and further, wherein said system for establishing an operative corridor to a surgical target site includes a series of sequential dilator cannulae, each having at least one stimulation electrode near a distal end.

5. The system set forth in claim 3 and further, wherein said surgical target site is a spinal target site.

6. The system set forth in claim 5 and further, wherein said operative corridor may be established via a lateral, trans-psoas approach.

7. The system set forth in claim 1 and further, wherein said surgical accessory comprises a pedicle testing device including a handle and a pedicle probe.

8. The system set forth in claim 7 and further, wherein said pedicle testing device is capable of testing at least one of the interior of a hole formed in a pedicle and a pedicle screw after insertion into said hole.

9. The system set forth in claim 8 and further, wherein said handle includes at least one button for initiating the transmission of said stimulation signal from said processing system to said pedicle probe.

10. The system set forth in claim 1 and further, wherein said surgical accessory comprises a nerve root retractor capable of retracting a nerve and monitoring nerve function at least one of before, during, and after surgery.

12. The system set forth in claim 10 and further, wherein said nerve root retractor includes a handle and a detachable nerve root retractor blade.

11. The system set forth in claim 11 and further, wherein said nerve root retractor monitors nerve function through at least one of monopolar and bipolar stimulation of said retracted nerve.