Systems and devices for neural stimulation and controlled drug delivery

Abstract

Medical devices and methods are provided for electrical stimulation of neural tissue and controlled drug delivery to a patient. The device includes an implantable drug delivery module which comprises a plurality of reservoirs, a release system comprising at least one drug contained in each of the reservoirs, and control means for selectively releasing a pharmaceutically effective amount of drug from each reservoir; a neural electrical stimulator which comprises a signal generator connected to at least one stimulation electrode for operable engagement with a neural tissue of the patient; and at least one microcontroller for controlling operational interaction of the drug delivery module and the neural electrical stimulator. The microcontroller may control the signal generator and the control means of the drug delivery module. The device may further include a sensor operable to deliver a signal to the microcontroller, for example to indicate when to deliver electrical stimulation, drug, or both.

1 . A system for electrical stimulation of neural tissue in a patient and controlled drug delivery to the patient, comprising:
 a drug delivery module suitable for implantation in the patient at a first site, the module comprising
 a plurality of reservoirs containing at least one drug, each reservoir having at least one opening for release of the drug, 
 electrically conductive reservoir caps closing off the openings of the reservoirs, and 
 a power source and control circuitry for disintegrating the reservoir caps; 
   a stimulator module suitable for implantation in the patient at a second site, the stimulator comprising
 an electrical signal generator, and 
 at least one stimulation electrode for operable engagement with a neural tissue of the patient, wherein the stimulation electrode is operably connected to the electrical signal generator; and 
   at least one microcontroller for controlling the drug delivery module and the stimulator module.   
   
   
       2 . The system of  claim 1 , wherein the stimulation electrode comprises a peripheral nerve stimulation lead. 
   
   
       3 . The system of  claim 1 , wherein the stimulation electrode comprises a deep brain catheter lead/electrode for treating movement disorders or tremors. 
   
   
       4 . The system of  claim 1 , wherein a drug delivery device is configured for subcutaneous implantation. 
   
   
       5 . The system of  claim 1 , wherein the drug delivery module comprises a flexible catheter which comprises the drug-containing reservoirs. 
   
   
       6 . The system of  claim 1 , wherein the at least one microcontroller controls both the signal generator and the disintegration of the reservoir caps. 
   
   
       7 . The system of  claim 1 , wherein the at least one microcontroller controls the drug delivery module by a telemetry signal. 
   
   
       8 . The system of  claim 1 , wherein the at least one microcontroller controls the drug delivery module by a hard-wired signal. 
   
   
       9 . The system of  claim 1 , wherein the at least one microcontroller is located in the drug delivery module. 
   
   
       10 . The system of  claim 1 , wherein the at least one microcontroller is located in the stimulation module. 
   
   
       11 . The system of  claim 1 , comprising two microcontrollers, one of which controls the stimulator module and the other which controls the drug delivery module. 
   
   
       12 . The system of  claim 11 , wherein the first and second microcontroller are operably connected to each other. 
   
   
       13 . The system of  claim 1 , wherein the drug delivery module comprises a pump for subcutaneous implantation and a catheter having a proximal end in fluid connection to the pump and a distal end for insertion into an intrathecal space, the drug-containing reservoirs being provided in the catheter in a configuration to release the drug into an infusion fluid pumped through the catheter. 
   
   
       14 . The system of  claim 13 , wherein the power source and control circuitry are housed with the pump at a proximal end of the catheter and electrical traces are built into the catheter and operably connected to the reservoir caps covering reservoir openings at the distal end of the catheter. 
   
   
       15 . The system of  claim 1 , wherein each of the reservoir caps is connected to an electrical input lead and to an electrical output lead. 
   
   
       16 . A method for treating a patient, comprising:
 implanting a drug delivery module in the patient, the drug delivery module being configured to provide controlled release of a drug to a first site in the patient;   implanting a neural stimulation module in the patient, the neural stimulation module being configures to stimulate a neural tissue at a second site in the patient; and   controlling with at least one microcontroller the controlled release of the drug and the stimulation of the neural tissue.   
   
   
       17 . The method of  claim 16 , wherein the drug delivery module comprises a plurality of discrete reservoirs containing the drug, and a plurality of reservoir caps closing off openings in the reservoirs, and wherein release of the drug from the drug delivery module comprising disintegrating the reservoir caps. 
   
   
       18 . The method of  claim 16 , wherein the stimulator module comprises an electrical signal generator and an electrical lead extending through a stimulation catheter and connecting to a stimulation electrode. 
   
   
       19 . The method of  claim 18 , wherein the second site is selected from cutaneous nerves, somatic nerves, peripheral nerves, median nerves, peroneal nerves, ulnar nerves, ansalenticularis nerves, vagus nerves, carotid sinus, and the brain.