Systems and methods for performing surgical procedures and assessments

• US 8,977,352 B2
• Filed: 05/15/2014
• Issued: 03/10/2015
• Est. Priority Date: 09/25/2001
• Status: Expired due to Term

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Farquhar, Allen, Blewett, Jeffrey J., Gharib, James E., Kaula, Norbert F., Finley, Eric, Martinelli, Scot
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Foreman, Jonathan M
• Application Number:
  US14/278,862
• Publication Number:
  US 20140249446A1
• Time in Patent Office: 299 Days
• Field of Search: 600/546, 600/554, 606/32, 606/41, 607115-117, 623/17.11
• 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 inserting a spinal implant through a trans-psoas operative corridor to an intervertebral disc, comprising:

an elongate inner instrument to advance in a trans-psoas path through bodily tissue toward a lateral aspect of the targeted intervertebral disc of the lumbar spine, the elongate inner instrument being configured to engage an annulus of the targeted intervertebral disc;

a set of trans-psoas dilators to dilate the trans-psoas path through the bodily tissue toward the lateral aspect of the targeted intervertebral disc of the lumbar spine, the set of trans-psoas dilators comprising at least a first dilator to slidably engage with an exterior of the elongate inner instrument and having a first length;

wherein at least one instrument of the group consisting of the elongate inner instrument and a dilator of the set of trans-psoas dilators comprises a stimulation electrode exposed along a distal tip portion of said at least one instrument to emit an electrical stimulation signal to the bodily tissue for nerve monitoring when said at least one instrument is positioned in the trans-psoas path through the bodily tissue, wherein said at least one of instrument is electrically insulated along an entire length thereof with the exception of;

at least one exposed electrical contact positioned at a proximal end region of said at least one of instrument, and said stimulation electrode positioned on the distal tip region of said at least one of instrument; and

a working corridor instrument slidable over an outermost dilator of the set of trans-psoas dilators along the trans-psoas path through the bodily tissue to the lateral aspect of the targeted intervertebral disc of the lumbar spine, the working corridor instrument being configured to enlarge the trans-psoas path through the bodily tissue and maintain a trans-psoas operative corridor that is dimensioned so as to pass a spinal implant through the trans-psoas operative corridor to the lumbar spine.

2. The system of claim 1, wherein the working corridor instrument has an insertion length configured to extend through the bodily tissue to the lateral aspect of the targeted intervertebral disc, the insertion length of the working corridor instrument being less than a length of the outmost dilator of the set of trans-psoas dilators.

3. The system of claim 2, wherein the working corridor instrument is configured to maintain the trans-psoas operative corridor that is dimensioned to have a corridor width extending generally perpendicular to the trans-psoas path, and wherein the working corridor instrument comprises an external proximal portion that is configured to reside external to a patient and that has a maximum width that is generally perpendicular to the trans-psoas path and greater than the corridor width.

4. The system of claim 1, further comprising a nerve monitoring system is configured to deliver the electrical stimulation signal to the stimulation electrode of said at least one instrument, to monitor leg muscle activity detected by a set of sensor electrodes in leg muscle myotomes associated with nerves in the vicinity of the lumbar spine, and to display onscreen a numeric stimulation threshold that changes in response to the leg muscle activity detected in at least one of said leg muscle myotomes.

5. The system of claim 4, wherein the monitoring system comprises a control unit having a video display device, a patient module configured to connect to the control unit via a data cable, an EMG sensor harness having the set of sensor electrodes configured to connect to the patient module.

6. The system of claim 5, wherein the control unit is configured to receive signals from the patient module and process EMG responses output from the sensor electrodes to extract characteristic information for each of said leg muscle myotomes.

7. The system of claim 4, wherein the monitoring system is configured to display onscreen said numeric stimulation threshold in the form of a numeric value of an electrical current in units of milliAmps.

8. The system of claim 7, wherein a color display screen of the nerve monitoring system is configured to display a color code corresponding to the numeric stimulation threshold.

9. The system of claim 1, wherein the set of trans-psoas dilators and the elongate inner instrument are removable from the working corridor instrument so as to establish the trans-psoas operative corridor to the lateral aspect of the targeted spinal disc.

10. The system of claim 1, wherein the working corridor instrument is shaped to define a generally cylindrical operative corridor.

11. The system of claim 1, wherein the elongate inner instrument is configured to advance together with the first dilator in the trans-psoas path through the bodily tissue toward the lateral aspect of the targeted intervertebral disc of the lumbar spine.

12. The system of claim 1, wherein the elongate inner instrument comprises a K-wire.

13. The system of claim 1, wherein the working corridor instrument comprises a cannula or a retractor system.

14. The system of claim 1, further including a stimulation connector with a first end releasably attachable to said proximal end region of said at least one of instrument and a cable for establishing electrical communication between said stimulation connector and a nerve monitoring system, said first end being configured to provide electrical communication between said at least one exposed electrical contact positioned at the proximal end region of said at least one of instrument when said stimulation connector is attached to said proximal end region.

15. The system of claim 14, wherein said stimulation connector comprises a clamp device.

16. The system of claim 1, wherein the set of trans-psoas dilators further comprises a second dilator configured to slide over the first dilator and a third dilator configured to slide over the second dilator, and wherein:

the second dilator further comprises;

a proximal connector region configured to releasably mate with an electrical cable of a nerve monitoring system, and a respective stimulation electrode exposed along a tapered distal tip region of the second dilator to emit the electrical stimulation signal to the bodily tissue for nerve monitoring when the second dilator is positioned in the trans-psoas path; and

the third dilator further comprises;

a proximal connector region configured to releasably mate with the electrical cable of the nerve monitoring system, and a respective stimulation electrode exposed along a tapered distal tip region of the third dilator to emit the electrical stimulation signal to the bodily tissue for nerve monitoring when the third dilator is positioned in the trans-psoas path.

17. The system of claim 16, further comprising an electrical cable for a nerve monitoring system, wherein a distal end of the electrical cable includes a connector device that is shaped to releasably receive the proximal connector region of the second dilator and to releasably receive the proximal connector region of the third dilator.