IP Library Granted Patent US 8,244,343
Granted Patent B2
US 8,244,343 · App. 13/215,791 · Granted Aug 14, 2012

System and methods for performing surgical procedures and assessments

Assignee: NuVasive, Inc.
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Quick Facts
Patent No.
US 8,244,343
App. No.
13/215,791
Granted
Aug 14, 2012
Kind
B2
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 (19)

1. A system for inserting a spinal implant through a trans-psoas operative corridor to an intervertebral disc, comprising:

an elongate stimulation 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 stimulation instrument comprising: an elongate body, a distal tip portion configured to engage an annulus of the targeted intervertebral disc, and a stimulation electrode exposed along the distal tip portion to emit an electrical stimulation signal to the bodily tissue for nerve monitoring while the elongate stimulation instrument is positioned in the trans-psoas path through the bodily tissue;

a plurality of trans-psoas dilators of increasing diameters to dilate the trans-psoas path through the bodily tissue toward the lateral aspect of the targeted intervertebral disc of the lumbar spine, the plurality of dilators comprising:

an first dilator to slidably engage with an exterior of the elongate stimulation instrument and having a first length,

a second dilator to slidably engage with an exterior of the initial dilator and having a second length less than the first length of the initial dilator, wherein the second dilator comprises: a proximal connector region configured to releasably mate with an electrical cable of a nerve monitoring system, and a stimulation electrode exposed along a tapered distal tip region of the second dilator to emit an electrical stimulation signal to the bodily tissue for nerve monitoring while the second dilator is positioned in the trans-psoas path, and

a third dilator to slidably engage with an exterior of the second dilator and having a third length less than the second length of the second dilator, wherein the third dilator comprises: a proximal connector region configured to releasably mate with the electrical cable of a nerve monitoring system, and a stimulation electrode exposed along a tapered distal tip region of the third dilator to emit an electrical stimulation signal to the bodily tissue for nerve monitoring while the third dilator is positioned in the trans-psoas path;

a working corridor instrument slidable over an outermost of the plurality 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 define a trans-psoas operative corridor along the trans-psoas path through the bodily tissue toward the lateral aspect of the targeted intervertebral disc of the lumbar spine, wherein the trans-psoas operative corridor defined by the working corridor instrument is dimensioned so as to pass a spinal fusion implant through the trans-psoas operative corridor to the targeted intervertebral disc of 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 the third length of the third dilator.

3. The system of claim 2 , wherein the working corridor instrument comprises an external proximal portion that has a maximum width greater than a maximum lateral width of the trans-psoas operative corridor to be defined by the working corridor instrument.

4. The system of claim 1 , further comprising a nerve monitoring system that delivers the electrical stimulation signal to the stimulation electrode of the elongate stimulation instrument, monitors electromyographic activity detected by a set of sensor electrodes in leg muscle myotomes associated with nerves in the vicinity of the lumbar spine, and displays a numeric stimulation threshold required to obtain the electromyographic activity 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 connected to the control unit via a data cable, an EMG sensor harness having the set of sensor electrodes connected to the patient module.

6. The system of claim 5 , wherein the control unit receives signals from the patient module and processes 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 displays said numeric stimulation threshold in the form of a numeric value of an electrical current.

8. The system of claim 1 , wherein the plurality of trans-psoas dilators and the elongate stimulation instrument are removable from the working corridor instrument after the working corridor instrument advances to the lateral aspect of the targeted intervertebral disc of the lumbar spine to establishing the trans-psoas operative corridor to the intervertebral disc of the spine.

9. The system of claim 1 , 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.

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 stimulation instrument is configured to advance together with the initial 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 stimulation instrument comprises a K-wire.

13. The system of claim 1 , wherein the working corridor instrument comprises a working cannula that defines a lumen.

Assignments (4)
SECURITY INTEREST Recorded Feb 28, 2020
From: NUVASIVE, INC.; NUVASIVE CLINICAL SERVICES MONITORING, INC.; NUVASIVE CLINICAL SERVICES, INC.; NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 052918/0595 →
NOTICE OF GRANT OF SECURITY INTEREST IN PATENTS Recorded May 17, 2017
From: NUVASIVE, INC.; BIOTRONIC NATIONAL, LLC; NUVASIVE CLINICAL SERVICES MONITORING, INC.; NUVASIVE CLINICAL SERVICES, INC.; NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 042490/0236 →
NOTICE OF GRANT OF SECURITY INTEREST IN PATENTS Recorded Nov 16, 2016
From: NUVASIVE, INC.; IMPULSE MONITORING, INC.
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 040634/0404 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 3, 2012
From: GHARIB, JAMES; FARQUHAR, ALLEN; KAULA, NORBERT F.; BLEWETT, JEFFREY J.; FINLEY, ERIC; MARTINELLI, SCOT
To: NUVASIVE, INC.
Reel/Frame 027976/0554 →
Continuity (5)
Continuation 12423559 · Apr 14, 2009
Continuation 10809280 · Mar 25, 2004
Continuation PCTUS0230617 · Sep 25, 2002
Provisional Application 60325424 · Sep 25, 2001
Related Publication 20110313530A1 · Dec 22, 2011