Systems, devices and methods for implantable neuromodulation stimulation

Abstract

The present invention comprises implantable neuromodulation systems and methods comprising a protective pouch that at least partially encases an implantable pulse generator prior to implanting in a patient and is adapted to be secured within the surgical site. The pouch may be secured to a pedicle screw and/or a fixation rod, or to a vertebral body.

1 . A pouch for at least partially encasing an implantable pulse generator (“IPG”) for implantation within a surgical site, the pouch comprising:
 opposing first and second major surface walls; 
 
       wherein the opposing first and second major surface walls define an interior plenum that is configured to receive and at least partially enclose the IPG therein, wherein the pouch is adapted to be secured within the surgical site;
 one or more apertures or discontinuities in the pouch sized and adapted to allow at least one electrical lead operatively connected to the IPG to pass through the pouch; and 
 an attachment surface extending from the pouch, the attachment surface adapted for attaching the pouch to a pedical screw disposed within the surgical site. 
 
     
     
         2 . The pouch of  claim 2 , wherein the pedicle screw comprises a pedicle screw head defining at least one receiving wall, and wherein the attachment surface comprises at least one side wall adapted to engage a corresponding receiving wall of the pedicle screw head. 
     
     
         3 . The pouch of  claim 2 , wherein the IPG is at least partially encased within the pouch and wherein the attachment surface is adapted to maintain the IPG and the pouch in a fixed relationship with respect to the pedicle screw. 
     
     
         4 . The pouch of  claim 3 , further comprising a connecting element configured to engage a portion of a fixation rod. 
     
     
         5 . The pouch of  claim 4 , wherein the portion of the connecting element that engages a portion of the fixation rod further comprises a contoured end wall. 
     
     
         6 . The pouch of  claim 1 , further comprising at least one additional wall disposed between the first and second major surface walls. 
     
     
         7 . The pouch of  claim 1 , wherein the pouch is coated or impregnated with at least one material having one or more of the properties of the group consisting of antimicrobial, antifungal, antibiotic, anti-infection, analgesic properties, drug-eluting, tissue growth inhibiting, and tissue growth enhancing. 
     
     
         8 . A pouch for at least partially encasing an implantable pulse generator (“IPG”) for implantation within a surgical site, the pouch comprising:
 opposing first and second major surface walls; 
 
       wherein the opposing first and second major surface walls define an interior plenum that is configured to receive and at least partially enclose the IPG therein, wherein the pouch is adapted to be secured within the surgical site;
 one or more apertures or discontinuities in the pouch sized and adapted to allow at least one electrical lead operatively connected to the IPG to pass through the pouch; and 
 an attachment member extending from a portion of the pouch adapted to engage a fixation rod. 
 
     
     
         9 . The pouch of  claim 8 , further comprising an outwardly extending connecting element adapted to engage the fixation rod. 
     
     
         10 . The pouch of  claim 9 , wherein the outwardly extending connecting element comprises a contoured engagement surface for engaging the outer surface of the fixation rod. 
     
     
         11 . The pouch of  claim 10 , wherein the contoured engagement surface comprises a complementary shape with respect to the outer surface of the fixation rod. 
     
     
         12 . The pouch of  claim 8 , wherein the attachment member is adapted to maintain the pouch in a fixed relationship with the fixation rod. 
     
     
         13 . The pouch of  claim 8 , wherein the pouch is coated or impregnated with at least one material having one or more of the properties of the group consisting of antimicrobial, antifungal, antibiotic, anti-infection, analgesic properties, drug-eluting, tissue growth inhibiting, and tissue growth enhancing. 
     
     
         14 . A method for treating pain generated by a patient's spinal column in a combined procedure using vertebral stabilization and neuromodulation stimulation, comprising:
 identifying two or more targeted vertebral levels for vertebral stabilization;   identifying one or more targeted spinal levels for neuromodulation stimulation, including at least one targeted dorsal root ganglion;   creating an open access into the resulting spinal treatment site to provide direct visual access to the identified targeted vertebral levels and the at least one identified targeted spinal level and the at least one targeted dorsal root ganglion;   stabilizing the identified vertebral levels; and   placing a neuromodulation system comprising:
 an implantable pulse generator, wherein the implantable pulse generator is at least partially enclosed within a biocompatible pouch, wherein the biocompatible pouch is secured within the spinal treatment site, 
 at least one electrical lead in operative electrical communication with the implantable pulse generator, wherein the at least one electrical lead is routed from the implantable pulse generator through at least one aperture in the biocompatible pouch to a location within therapeutic proximity of the at least one targeted dorsal root ganglion at each of the one or more target spinal levels, and 
 at least one electrode disposed at a distal end of the at least one electrical lead, wherein the at least one electrode is placed in therapeutic proximity with each of the at least one targeted dorsal root ganglion at each of the one or more target spinal levels; and 
   closing the open access.   
     
     
         15 . The method of  claim 13 , wherein the stabilizing of the identified vertebral levels comprises securing the identified vertebral levels with two bilaterally spaced apart fixation rods, wherein each fixation rod is secured to vertebral bone with two or more pedicle screws; and
 securing the biocompatible pouch to at least one of the group consisting of: a pedicle screw, a fixation rod, and a vertebral body.   
     
     
         16 . A method for treating pain generated by a patient's spinal column in a combined procedure using neuromodulation stimulation, comprising:
 identifying one or more targeted spinal levels for neuromodulation stimulation, including at least one targeted dorsal root ganglion;   creating an open access into the resulting spinal treatment site to provide direct visual access to the at least one identified targeted spinal level and the at least one targeted dorsal root ganglion;   placing a neuromodulation system comprising:
 an implantable pulse generator, wherein the implantable pulse generator is at least partially enclosed within a biocompatible pouch, wherein the biocompatible pouch is secured within the spinal treatment site, 
 at least one electrical lead in operative electrical communication with the implantable pulse generator, wherein the at least one electrical lead is routed from the implantable pulse generator through at least one aperture in the biocompatible pouch to a location within therapeutic proximity of the at least one targeted dorsal root ganglion at each of the one or more target spinal levels, and 
 at least one electrode disposed at a distal end of the at least one electrical lead, wherein the at least one electrode is placed in therapeutic proximity with each of the at least one targeted dorsal root ganglion at each of the one or more target spinal levels; and 
   closing the open access.