Methods and Systems for Implanting a Neuromodulation System at a Surgically Open Spinal Treatment Site

Abstract

The present invention provides a single surgical method, procedure and/or system that creates open direct visual and/or physical access to an identified spinal treatment site that initially comprises spinal levels to be treated, wherein the spinal levels include at least one dorsal root ganglion. A spinal treatment procedure is performed generally in combination with implantation of a neuromodulation system that may comprise placement of electrical lead(s) on the at least one dorsal root ganglion, wherein each lead is in operative connection with a pulse generator that may also be implanted during the surgical method. Electrical stimulation may be generated with the low-profile pulse generator through the electrical leads to the at least one dorsal root ganglion during and/or after the closure of the identified spinal treatment site.

1 . A neuromodulation system adapted for implantation into a surgical site proximate a patient's spinal column following vertebral stabilization comprising bilaterally spaced fixation rods, each comprising a shape, across two or more targeted vertebral levels, the neuromodulation system including an implantable pulse generator comprising:
 a top side;   a bottom side;   connecting sides extending between the top side and the bottom side,   wherein the bottom side comprises a rod fixation element formed therein and adapted to connect and affix to one of the bilaterally spaced fixation rods.   
     
     
         2 . The neuromodulation system of  claim 1 , wherein the rod fixation element defines a curved receptacle extending along a length of the bottom side. 
     
     
         3 . The neuromodulation system of  claim 1 , wherein a portion of a length of one fixation rod is received within the curved receptacle defined by the rod fixation element. 
     
     
         4 . The neuromodulation system of  claim 3 , wherein a portion of the fixation rod received within the curved receptacle extends outwardly away from the connecting sides of the implantable pulse generator. 
     
     
         5 . The neuromodulation system of  claim 3 , wherein no portion of the fixation rod received within the curved receptacle extends outwardly away from the connecting sides of the implantable pulse generator. 
     
     
         6 . The neuromodulation system of  claim 2 , wherein the curved receptacle defined by the rod fixation element comprises a shape that is complementary to the shape of the fixation rod to which the rod fixation element is connected and affixed. 
     
     
         7 . The neuromodulation system of  claim 6 , wherein the shape of the curved receptacle defined by the rod fixation element is selected from the group consisting of circular, elliptical, and curvilinear. 
     
     
         8 . The neuromodulation system of  claim 1 , wherein the rod fixation element is adapted to connect to, and maintain placement and position of, the implantable pulse generator after implantation of the implantable pulse generator. 
     
     
         9 . The neuromodulation system of  claim 1 , further comprising:
 at least one electrical lead in operative electrical communication with the implantable pulse generator and that is routed from the implantable pulse generator to at least one dorsal root ganglion located within the surgical site; and   at least one electrode disposed at a distal end of the at least one electrical lead,   wherein the at least one electrode is configured to be placed in therapeutic proximity with at least one dorsal root ganglion within the surgical site.   
     
     
         10 . The neuromodulation system of  claim 9 , wherein the at least one electrical lead is configured to be routed using direct visual access created by an open access into the surgical site. 
     
     
         11 . The neuromodulation system of  claim 9 , wherein the at least one electrode is configured to be placed using direct visual access created by an open access into the surgical site. 
     
     
         12 . The neuromodulation system of  claim 1 , wherein the implantable pulse generator is configured to connect and affix to one of the bilaterally spaced fixation rods using direct visual access created by an open access into the surgical site. 
     
     
         13 . The neuromodulation system of  claim 10 , wherein at least routed one electrical lead is adapted to be routed beneath at least one of the bilaterally spaced fixation rods. 
     
     
         14 . The neuromodulation system of  claim 10 , wherein the at least one electrical lead is adapted to be routed above at least one of the bilaterally spaced fixation rods. 
     
     
         15 . The neuromodulation system of  claim 10 , wherein the at least one electrical lead is adapted to be routed to cross a midline of the patient's spinal column. 
     
     
         16 . The neuromodulation system of  claim 10 , wherein the at least one electrical lead is adapted to be routed without crossing the midline of the patient's spinal column without crossing the midline of the patient's spinal column 
     
     
         17 . The neuromodulation system of  claim 9 , wherein the implantable pulse generator is adapted to be connect and affix to one of the bilaterally spaced fixation rods at a location that is anatomically inferior to at least one of the at least one electrodes placed in therapeutic proximity with each of the at least one targeted dorsal root ganglion. 
     
     
         18 . The neuromodulation system of  claim 1 , wherein the implantable pulse generator is adapted to connect and affix to one of the bilaterally spaced fixation rods at a location that is on one side of the midline of the spinal column. 
     
     
         19 . The neuromodulation system of  claim 9 , wherein the implantable pulse generator is adapted to connect and affix to one of the bilaterally spaced fixation rods at a location that is below at least one of the at least one electrodes placed in therapeutic proximity with the at least one dorsal root ganglion.