System and methods for monitoring during anterior surgery

• US 8,568,331 B2
• Filed: 02/02/2006
• Issued: 10/29/2013
• Est. Priority Date: 02/02/2005
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Bertagnoli, Rudolph, Gharib, James, Cornwall, G. Bryan, Schermerhorn, Rory
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US11/883,710
• Publication Number:
  US 20090105604A1
• Time in Patent Office: 2,826 Days
• Field of Search: 600/546, 600/554, 600/587, 600/210, 607/2, 607/48, 606/32, 606/170, 606/207, 606/83, 606/84, 606/90, 606/86
• US Class Current: 600/554
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 90/36 Image-producing devices or illumination devices not otherwise provided for

Abstract

The present invention involves a system and methods for nerve testing during anterior surgery, including but not limited to anterior total disc replacement surgery, nucleus replacement, and interbody fusion.

Claims

1. A surgical system for assessing disc space preparation during spine surgery, the disc space preparation including excising disc material from an interior of the disc space to make a cavity for receipt of an implant and leaving a layer of annulus tissue to insulate the prepared disc space from neural structures adjacent the annulus tissue, comprising:

a probe insertable into the cavity of the prepared disc space and configured to transmit a stimulation signal within said disc space to said annulus tissue, wherein said probe includes a handle and a probe member having at least two conductive pins aligned in a nonconductive housing, said conductive pins extending through the nonconductive housing and protruding for a portion from a distal end of the nonconductive housing, the probe member being configured such that the nonconductive pins contact an interior face of the annulus layer when the probe is inserted into the prepared disc space.

2. The surgical system of claim 1, further comprising:

a sensor configured to detect neuromuscular responses from muscle myotomes associated with said neural structures adjacent the annulus layer; and

a control unit coupled to said probe and said sensor, said control unit configured to (a) command transmission of said stimulation signal from said probe, (b) receive neuromuscular response data from said sensor, and (c) analyze the neuromuscular response data in relation to the stimulation signal to determine the degree of communication between said probe and said neural structures to assess the disc space preparation.

3. The surgical system of claim 2, wherein said sensor is configured to detect an EMG voltage output of said neuromuscular response and determine a peak-to-peak voltage of said voltage output to characterize said neuromuscular response.

4. The surgical system of claim 3, wherein said control unit determines a threshold stimulation current level necessary to evoke a neuromuscular response characterized by a predetermined peak-to-peak voltage to determine the degree of communication between said probe and said neural structures.

5. The surgical system of claim 2, wherein said control unit is further configured to direct stimulation signals and determine threshold current levels through all of the at least two pins, in sequence.

6. The surgical system of claim 2, further comprising a screen display for displaying at least one of alpha-numeric and graphical information regarding the degree of electrical communication between said probe and said neural structures.

7. The surgical system of claim 6, wherein said alpha-numerical and graphical information includes at least one of a bar graph illustrating threshold stimulation current level determinations, an image of a disc space including threshold stimulation current level determinations arrayed within the disc space image, and a numeral representing a threshold stimulation current level determination.

8. The surgical system of claim 2, further comprising a position tracking system operatively linked to said control unit and a tracking element fixed in a known position on said probe, said position tracking system being configured to register spatial coordinates of reference markers positioned at least one of on and near said annulus tissue, with coordinates of an image representing the disc space and shown on a display, said position tracking system being further configured to continuously determine the coordinate position of said probe relative to said reference markers, said control unit being further configured to display the position of said probe within said image of said disc space together with the results of said stimulation analysis.

9. The surgical system of claim 2, wherein said control unit is further configured to obtain visual images of said annulus tissue and display said images to a user.

10. The surgical system of claim 9, wherein said visual images are ultrasound images.

11. The surgical system of claim 9, wherein said probe includes at least one ultrasound transducer fixed near a distal end of said probe.

12. The surgical system of claim 1, further comprising at least one of an additional stimulation element for manually touching to a portion of one of said at least two pins extending from the proximal end of said probe member and emitting said stimulation signal through said pin, and an electrical connector including socket holes for mating with proximal ends of said at least two pins to automatically apply said stimulation signals to each of said at least two pins in sequence.

13. The surgical system of claim 1, wherein said at least two pins are individually compressible in a proximal direction.

14. The surgical system of claim 1, wherein said probe member is dimensioned such that if may contact a substantial portion of a posterior aspect of said annulus tissue.

15. The surgical system of claim 1, wherein said probe member is dimensioned such that the probe member may contact only a portion of at least one of a posterior, posteriolateral, and lateral aspect of said annulus tissue.

16. The surgical system of claim 1, wherein said probe member has one of a curved, rounded, half-rounded, and sloped distal end for matching different surface contours of said annulus tissue.

17. The surgical system of claim 1, wherein said nonconductive housing comprises at least two modular sections that may be added and removed to adjust the size and shape of said probe member.