System and methods for performing percutaneous pedicle integrity assessments

Abstract

The present invention involves systems and related methods for performing percutaneous pedicle integrity assessments involving the use of neurophysiology.

What is claimed is: 
     
         1 . A system for performing percutaneous pedicle integrity assessments during spine surgery, comprising:
 a stimulation element comprising a tubular insulation member with a longitudinal lumen therethrough, which is configured for percutaneous introduction to a pedicle target site within a patient and a K-wire which is disposed through the lumen of the tubular insulation member, wherein the K-wire comprises a stimulation region at a distal end which extends from a distal end of the tubular insulation member and which is configured for contacting at least one of a pilot hole formed in the pedicle target site and a screw implanted in the pedicle target site; and   a control unit in electrical communication with the K-wire, the control unit configured for selectively applying a stimulation signal to the K-wire, and monitoring to assess whether nerves adjacent the pedicle target site are innervating as a result of applying the stimulation signal to the K-wire.   
     
     
         2 . The system of  claim 1 , further comprising an electromyography monitoring system, wherein the electromyography monitoring system is in electrical communication with the control unit, wherein monitoring to assess whether nerves adjacent the pedicle target site are innervating further comprises detecting a voltage response from muscles innervated by the nerves via the electromyography monitoring system. 
     
     
         3 . The system of  claim 2 , wherein the electromyography monitoring system is in electrical communication with the K-wire and configured to direct the application of the stimulation signal. 
     
     
         4 . The system of  claim 3 , wherein the control unit is further configured to determine a relationship between the stimulation signal and the voltage response to indicate a measurement of integrity at the pedicle target site. 
     
     
         5 . The system of  claim 4 , wherein the relationship is a threshold stimulation current level required to evoke a predetermined voltage response value. 
     
     
         6 . The system of  claim 4 , wherein the electromyography monitoring system is further configured to communicate the relationship to a user. 
     
     
         7 . A system for performing percutaneous pedicle integrity assessments during spine surgery, comprising:
 a stimulation element comprising a tubular insulation element which is configured for percutaneous introduction to a pedicle target site within a patient, wherein the tubular insulation element is configured to receive a tap member and a K-wire, wherein the tap member comprises a longitudinal lumen for receiving and passing the K-wire for contacting a pilot hole formed in the pedicle target site; and   a control unit in electrical communication with the K-wire, the control unit configured for selectively applying a stimulation signal to the K-wire, and monitoring to assess whether nerves adjacent the pedicle target site are innervating as a result of applying the stimulation signal to the K-wire.   
     
     
         8 . The system of  claim 7 , further comprising an electromyography monitoring system, wherein the electromyography monitoring system is in electrical communication with the control unit, wherein monitoring to assess whether nerves adjacent the pedicle target site are innervating further comprises detecting a voltage response from muscles innervated by the nerves via the electromyography monitoring system. 
     
     
         9 . The system of  claim 8 , wherein the electromyography monitoring system is in electrical communication with the K-wire and configured to direct the application of the stimulation signal. 
     
     
         10 . The system of  claim 9 , wherein the control unit is further configured to determine a relationship between the stimulation signal and the voltage response to indicate a measurement of integrity at the pedicle target site. 
     
     
         11 . The system of  claim 10 , wherein the relationship is a threshold stimulation current level required to evoke a predetermined voltage response value. 
     
     
         12 . The system of  claim 10 , wherein the electromyography monitoring system is further configured to communicate the relationship to a user. 
     
     
         13 . The system of  claim 7 , wherein the stimulation element is an electric coupling device, wherein the electric coupling device engages a proximal end of the tap member. 
     
     
         14 . A system for performing percutaneous pedicle integrity assessments during spine surgery, comprising:
 a stimulation element comprising a tubular insulation element which is configured for percutaneous introduction to a pedicle target site within a patient, wherein the tubular insulation element is configured to receive a tap member, wherein the tap member is configured for contacting the pedicle target site; and   a control unit in electrical communication with the tap member, the control unit configured for selectively applying a stimulation signal to the tap member, and monitoring to assess whether nerves adjacent the pedicle target site are innervating as a result of applying the stimulation signal to the tap member.   
     
     
         15 . The system of  claim 14 , further comprising an electromyography monitoring system, wherein the electromyography monitoring system is in electrical communication with the control unit, wherein monitoring to assess whether nerves adjacent the pedicle target site are innervating further comprises detecting a voltage response from muscles innervated by the nerves via the electromyography monitoring system. 
     
     
         16 . The system of  claim 15 , wherein the electromyography monitoring system is in electrical communication with the tap member and configured to direct the application of the stimulation signal. 
     
     
         17 . The system of  claim 16 , wherein the control unit is further configured to determine a relationship between the stimulation signal and the voltage response to indicate a measurement of integrity at the pedicle target site. 
     
     
         18 . The system of  claim 17 , wherein the relationship is a threshold stimulation current level required to evoke a predetermined voltage response value. 
     
     
         19 . The system of  claim 17 , wherein the electromyography monitoring system is further configured to communicate the relationship to a user. 
     
     
         20 . The system of  claim 14 , wherein the stimulation element is an electric coupling device, wherein the electric coupling device engages a proximal end of the tap member.