IP Library Granted Patent US 8,641,638
Granted Patent B2
US 8,641,638 · App. 11/981,889 · Granted Feb 4, 2014

Electromyography system

Inventors: Brian S. Kelleher (Ramona, CA); James F. Marino (La Jolla, CA); Corbett W. Stone (San Diego, CA); Robin H. Vaughn (Escondido, CA); Jeffrey H. Owens (Monkton, MD)
Assignee: NuVasive, Inc.
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Quick Facts
Patent No.
US 8,641,638
App. No.
11/981,889
Granted
Feb 4, 2014
Kind
B2
Abstract

Methods for determining structural integrity of a bone within the spine of a patient, the bone having a first aspect and a second aspect, wherein the second aspect separated from the first aspect by a width and located adjacent to a spinal nerve. The methods involve (a) applying an electrical stimulus to the first aspect of the bone; (b) electrically monitoring a muscle myotome associated with the spinal nerve to detect if an onset neuro-muscular response occurs in response to the application of the electrical stimulus to the first aspect of the bone; (c) automatically increasing the magnitude of the electrical stimulus to until the onset neuro-muscular response is detected; and (d) communicating to a user via at least one of visual and audible means information representing the magnitude of the electrical stimulus which caused the onset neuro-muscular response.

Claims (35)

1. A method for testing the structural integrity of a spinal pedicle of a patient through a minimally invasive operative corridor to detect a defect in the structural integrity of a pedicle wall surrounding a pedicle screw path formed through the pedicle, said method comprising:

(a) advancing an elongate element to said pedicle via a minimally invasive approach through said patient;

(b) advancing a stimulation element through said elongate element to said pedicle, said stimulation element communicatively linked to a controller that directs application of an electrical stimulus;

(c) applying an electrical stimulus to said pedicle via said stimulation element;

(d) electrically monitoring with a sensor communicatively linked to said controller a muscle myotome associated with a spinal nerve lying adjacent to said pedicle to detect if an onset neuro-muscular response occurs in response to the application of said electrical stimulus;

(e) said controller automatically adjusting the magnitude of the electrical stimulus until said onset neuro-muscular response is detected, said controller determining the electrical stimulus magnitude that caused said onset neuro-muscular response;

(f) said controller interpreting the electrical stimulus magnitude which caused said onset neuro-muscular response and outputting an indicator indicative of the structural integrity of the pedicle; and

(g) redirecting the pedicle screw path when a defect in the structural integrity of the pedicle wall is indicated.

2. The method of claim 1 , wherein said stimulation element comprises at least one of a probe and a surgical tool, and step (c) involves applying said electrical stimulus from an electrode disposed on the distal end of said at least one of a probe and surgical tool.

3. The method of claim 1 , wherein said pedicle is disposed within one of the cervical, thoracic, and lumbar region of the patient's spine.

4. The method of claim 1 , wherein said onset neuro-muscular response is an electromyography response from a muscle coupled to said spinal nerve.

5. The method of claim 1 , wherein the sensor of step (d) is an EMG electrode electrically coupled to said muscle myotome.

6. The method of claim 1 , wherein the indicator of step (f) is a visual indicator.

7. The method of claim 1 and further, wherein the indicator of step (f) is an audible indicator.

8. The method of claim 1 , wherein step (c) involves applying said electrical stimulus to a proximal end of a pedicle screw inserted into said pedicle along said pedicle screw path.

9. The method of claim 1 , wherein said elongate element comprises a cannula.

10. The method of claim 1 , wherein the electrical stimulus comprises a plurality of current pulses.

11. The method of claim 10 , wherein the plurality of current pulses are automatically increased in constant increments over time until said onset neuromuscular response is determined.

12. The method of claim 10 , wherein the plurality of electrical stimulus pulses are increased incrementally within a range including a minimum stimulation current level and a maximum stimulation current intensity.

13. A method for performing pedicle integrity assessments with minimal tissue disruption to detect a defect in the structural integrity of a pedicle wall surrounding a pedicle screw path formed through the pedicle, said method comprising:

(a) advancing a minimally invasive cannula via a minimally invasive approach to a pedicle target site within a patient;

(b) delivering a stimulation signal to said pedicle target site via a stimulation element disposed through said cannula, said stimulation element communicatively linked to a controller that directs application of the electrical stimulus; and

(c) electrically monitoring with a sensor communicatively linked to said controller a muscle myotome innervated by a nerve adjacent to said pedicle to detect when an onset neuro-muscular response occurs in a muscle myotome innervated by said nerve in response to the delivery of said stimulation signal and determine the intensity level of the electrical stimulus that causes said onset neuro-muscular response;

(d) said controller interpreting the determined intensity level of the electrical stimulus that caused said onset neuro-muscular response and outputting at least one of visual and audible indicia indicative of the structural integrity of the pedicle; and

(e) redirecting the pedicle screw path when a defect in the structural integrity of the pedicle wall is indicated.

14. The method of claim 13 , wherein step (b) comprises automatically increasing the intensity level of the stimulation signal until said onset neuro-muscular response is detected.

15. The method of claim 14 , wherein step (b) further comprises delivering said stimulation signal as a plurality of electrical stimulus pulses that increase over time.

16. The method of claim 15 , wherein the plurality of electrical stimulus pulses comprises current pulses varied incrementally within a range including a minimum stimulation current intensity and a maximum stimulation current intensity.

17. The method of claim 13 , wherein said onset neuro-muscular response is an electromyography response from a muscle coupled to said nerves.

18. The method of claim 17 , wherein said sensor is an EMG electrode electrically coupled to said muscle myotome.

19. The method of claim 13 , wherein said pedicle target site is a proximal end of a pedicle screw implanted in said pedicle along said pedicle screw path.

20. The method of claim 13 , wherein said pedicle is within one of the cervical, thoracic, and lumbar regions of the patient's spine.

21. The method of claim 13 , wherein said stimulation element comprises at least one of a probe and a surgical tool, and step (b) involves delivering said stimulation signal from an electrode disposed on the distal end of said at least one of a probe and surgical tool.

22. The method of claim 13 , wherein step (d) involves visually indicating an intensity level of the stimulus that evoked the onset neuro-muscular response for said nerve and illuminating lights which correspond to predetermined warnings.

23. The method of claim 13 , wherein step (d) involves sounding an alarm if said determined intensity level is less than a predetermined intensity level.

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 Sep 17, 2012
From: KELLEHER, BRIAN S.; MARINO, JAMES F.; STONE, CORBETT W.; VAUGHN, ROBIN H.; OWENS, JEFFREY H.
To: NUVASIVE, INC.
Reel/Frame 028972/0453 →
Continuity (4)
Continuation 10830189 · Apr 21, 2004
Division 09722070 · Nov 24, 2000
Provisional Application 60167416 · Nov 24, 1999
Related Publication 20080064976A1 · Mar 13, 2008