Methods and systems for implanting a neuromodulation system and a spinal fixation system at a surgically open spinal treatment site

Abstract

The present invention provides a single surgical method, procedure and/or system that creates open visual and physical access to an identified spinal treatment site that comprises both targeted vertebral and spinal levels to be treated, wherein the spinal levels comprise 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 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 vertebral stabilization and neuromodulation system comprising:
 a vertebral stabilization system comprising:
 two fixation rods; and 
 two or more pedicle screws, 
 wherein the fixation rods are adapted to be secured to vertebral bone by the pedicle screws and configured to be bilaterally spaced apart when the fixation rods are secured to vertebral bone; and 
   a neuromodulation system comprising:
 an implantable pulse generator; 
 at least one electrical lead in operative electrical communication with the implantable pulse generator; and 
 at least one electrode disposed at a distal end of the at least one electrical lead, 
   wherein the implantable pulse generator is adapted to be secured to at least one of the fixation rods,   wherein the implantable pulse generator comprises one or more rod fixation extension arms, each rod fixation extension arm extending from a corner of a top or a bottom side of the implantable pulse generator, wherein each of the one or more rod fixation arms are configured to be affixed to one of the fixation rods.   
     
     
         2 . The vertebral stabilization and neuromodulation system of  claim 1 , wherein the implantable pulse generator comprises four corners and wherein a rod fixation arm extends from each corner. 
     
     
         3 . The system of  claim 1 , further comprising a spanning rod adapted to be fixed between the two fixation rods. 
     
     
         4 . A vertebral stabilization and neuromodulation system comprising:
 a vertebral stabilization system comprising:
 two fixation rods; 
 two or more pedicle screws; 
   wherein the fixation rods are configured to be secured to vertebral bone by the pedicle screws and configured to be bilaterally spaced apart when the fixation rods are secured to vertebral bone; and   a neuromodulation system comprising:
 an implantable pulse generator; 
   at least one electrical lead in operative electrical communication with the implantable pulse generator; and   at least one electrode disposed at a distal end of the at least one electrical lead,   wherein the implantable pulse generator comprises a top surface and a bottom surface, the bottom surface comprising a rod fixation element configured to affix the implantable pulse generator to one of the fixation rods.   
     
     
         5 . The system of  claim 4 , wherein the two fixation rods comprise a shape and wherein the rod fixation element comprises a shape that is complementary to the shape of the fixation rods. 
     
     
         6 . The system of  claim 5 , wherein one of the fixation rods engages and fits within the rod fixation element. 
     
     
         7 . The system of  claim 5 , wherein the rod fixation element comprises a curved receptacle surface. 
     
     
         8 . The system of  claim 7 , wherein the curved receptacle surface is configured to engage a corresponding curved surface of one of the fixation rods. 
     
     
         9 . An implantable pulse generator, comprising:
 a top surface;   a bottom surface;   connecting sides extending between the rectangular top and bottom surfaces; and   a rod fixation element defined within the bottom surface, wherein the rod fixation element comprises a curved receptacle surface along a length of the bottom surface.   
     
     
         10 . An implantable pulse generator, comprising:
 A four-cornered rectangular body comprising:
 a rectangular top surface with four corners; 
 a rectangular bottom surface with four corners; 
 connecting sides extending between the rectangular top and bottom surfaces; and 
   One or more rod fixation extension arms extending away from the implantable pulse generator.   
     
     
         11 . The implantable pulse generator of  claim 10 , wherein each one of the one or more rod fixation extension arms extends away from one of the four corners of the rectangular body. 
     
     
         12 . The implantable pulse generator of  claim 10 , further comprising four rod fixation arms, each one of the four rod fixation elements extending away from one of the four corners of the rectangular body. 
     
     
         13 . The implantable pulse generator of  claim 12 , wherein the four rod fixation elements extend away from the rectangular body in a generally X-shaped configuration.