System, devices, and methods combining spinal stabilization and neuromodulation

Abstract

A pain management system includes a spinal stabilization device and a neuromodulation device. The spinal stabilization device includes a rod, a plurality of pedicle screws each having a screw-head defining a screw-head cavity configured to receive a portion of the rod, and a corresponding plurality of inserts configured to engage with the inner wall of the cavity to secure the rod in place in the cavity. The neuromodulation device includes a therapy module comprising electronics packaged within a housing. The housing has a form factor having at least one feature configured to mate with a corresponding feature of the screw-head of one of the plurality of pedicle screws. The respective features mate in a manner that enables the therapy module to mechanically couple to and subsequently decouple from the screw-head of the pedicle screw.

What is claimed is: 
     
         1 . An implantable medical lead comprising:
 a ribbon structure having a first side and a second side opposite the first side;   a plurality of first electrodes associated with the first side and arranged in a first pattern; and   a plurality of second electrodes associated with the second side and arranged in a second pattern;   wherein the ribbon structure is configured to transition from a planar state to a non-planar state upon the application of a force and to remain in the non-planar state upon removal of the force.   
     
     
         2 . The lead of  claim 1 , wherein the non-planar state corresponds to an undulating state during which the ribbon structure bends in at least one, or in a series of successive curves in alternating directions, along a longitudinal axis extending down the center of the ribbon structure. 
     
     
         3 . The lead of  claim 2 , wherein the undulating state comprises at least one curve having a radius of curvature in the range of 1 mm and 3 mm. 
     
     
         4 . The lead of  claim 1 , wherein the non-planar state corresponds to a twisted state during which the edges of the ribbon structure along the length of the ribbon structure curve about a longitudinal axis extending down the center of the ribbon structure. 
     
     
         5 . The lead of  claim 1 , wherein the first pattern is a two-dimensional array and the plurality of first electrodes are separated by electrically insulative material associated with the first side of the ribbon structure. 
     
     
         6 . The lead of  claim 1 , wherein the second pattern is a two-dimensional array and the plurality of second electrodes are separated by electrically insulative material associated with the second side of the ribbon structure. 
     
     
         7 . The lead of  claim 1 , wherein the first electrodes and the second electrodes have a length in range of 2 mm to 4 mm and a width in the range of 0.25 mm and 2 mm. 
     
     
         8 . The lead of  claim 1 , wherein the spacing between adjacent first electrodes or adjacent second electrodes along the length of the ribbon structure is no more than two times the length of the first electrodes or the second electrodes. 
     
     
         9 . The lead of  claim 1 , wherein the spacing between adjacent first electrodes or adjacent second electrodes across the width of the ribbon structure  506  is no more than two times the width of the first electrodes or the second electrodes. 
     
     
         10 . The lead of  claim 1 , wherein the ribbon structure is characterized by a length in the range of 3 cm to 8 cm and a width in the range of 2 mm to 5 mm. 
     
     
         11 . The lead of  claim 1 , wherein the ribbon structure is characterized by a thickness in the range of 0.25 mm to 1 mm. 
     
     
         12 . The lead of  claim 1 , wherein the first pattern and the second pattern arrange the plurality of first electrodes and the plurality of second electrodes relative to each other so that no first electrode aligns with a second electrode along an axis extending perpendicular through either a first electrode or a second electrode and through the ribbon structure. 
     
     
         13 . The lead of  claim 1 , wherein the first pattern and the second pattern arrange the plurality of first electrodes and the plurality of second electrodes relative to each other so that a first electrode aligns with a second electrode along an axis extending perpendicular through either a first electrode or a second electrode and through the ribbon structure. 
     
     
         14 . The lead of  claim 1 , further comprising a proximal-end region having a lead interface structure configured to mechanically couple to and subsequently decouple from an interface structure of a therapy module. 
     
     
         15 . The lead of  claim 14 , wherein the lead interface structure comprises a plurality of electrical contacts, each electrically coupled to one of the first or second electrodes. 
     
     
         16 . The lead of  claim 1 , wherein the plurality of first electrodes and the plurality of second electrodes are separately formed and integrated into the ribbon structure. 
     
     
         17 . The lead of  claim 1 , wherein the plurality of first electrodes and the plurality of second electrodes are formed on the ribbon structure by thin film deposition. 
     
     
         18 . The lead of  claim 1 , further comprising at least one sensor associated with the ribbon structure. 
     
     
         19 . The lead of  claim 18 , wherein the at least one sensor comprises at least one of at least one temperature sensor arranged within the first side of the ribbon structure and at least one temperature sensor arranged within the second side of the ribbon structure. 
     
     
         20 . The lead of  claim 1 , wherein the ribbon structure further comprises a layer of insulative material sandwiched between the plurality of first electrodes on the first side of the ribbon structure, and the plurality of second electrodes on the second side of the ribbon structure.