Device and method to selectively and reversibly modulate a nervous system structure to inhibit pain

Abstract

The present disclosure is directed to a system and method for selectively and reversibly modulating targeted neural and non-neural tissue of a nervous system for the treatment of pain. An electrical stimulation is delivered to the treatment site that selectively and reversibly modulates the targeted neural- and non-neural tissue of the nervous structure, inhibiting pain while preserving other sensory and motor function, and proprioception.

What is claimed: 
     
         1 . A method for selectively and reversibly modulating targeted neural- and non-neural tissue of a nervous system structure with electrical stimulation to treat a medical condition of a patient, the method comprising:
 identifying a targeted nervous system structure;   positioning an electrical stimulation device at a treatment site proximate the targeted neural- and non-neural tissue of the nervous system structure, the electrical stimulation device comprising an electrode that provides an electrical stimulation to the treatment site, the electrode having an elongated body with a proximal and distal electrical contacts positioned thereon, the distal electrical contact sized and configured to interface with the targeted neural and non-neural tissue of the nervous system structure, the proximal contact sized and configured to be positioned in subcutaneous tissue;   delivering an electrical stimulation to the treatment site via the electrode;   wherein the application of the electrical stimulation to the treatment site selectively modulates the targeted neural- and non-neural tissue of the nervous system structure inhibiting pain and preserving other sensory and motor function, and proprioception;   wherein the application of the electrical stimulation to the treatment site selectively modulates the targeted neural- and non-neural tissue and results in subsequent inhibition of pain.   
     
     
         2 . The method of  claim 1 , wherein the nervous system structure comprises at least one of a peripheral nerve, a cranial nerve, a ganglia, an autonomic nerve, or autonomic ganglia. 
     
     
         3 . The method of  claim 1 , wherein the application of the electrical stimulation to the treatment site selectively modulates the targeted neural- and non-neural tissue inhibiting nerve signal transmission through nerve fibers that are responsible for the transmission of pain,
 wherein nerve signal transmission through nerve fibers responsible for other sensory and motor function, and proprioception is preserved,   wherein other sensory function includes at least one of touch, vision, audition, gustation, olfaction, or balance.   
     
     
         4 . The method of  claim 1 , wherein the pain comprises at least one of acute pain, surgical pain, post-surgical pain, trauma pain, neuropathic pain, chronic pain, or head-and-face pain. 
     
     
         5 . The method of  claim 1 , wherein the pain is acute pain,
 wherein the electrical stimulation is applied at least one of immediately prior to a surgical procedure, intraoperatively, and/or immediately following a surgical procedure or trauma.   
     
     
         6 . The method of  claim 1 , wherein the electrical stimulation is delivered to the treatment site more than 24 hours prior to a surgical procedure. 
     
     
         7 . The method of  claim 1 , wherein when the pain is post-surgical acute pain following a knee arthroplasty procedure, the electrical stimulation is applied to the femoral nerve, the sciatic nerve, the obturator nerve, or the lateral cutaneous nerve and nerve branches, or a combination thereof,
 wherein when the pain is shoulder pain, the electrical stimulation is applied to the brachial plexus, the axillary nerve, the suprascapular nerve or lateral pectoral nerve, or a combination thereof,   wherein when the pain is associated with a medical procedure and/or trauma to the arm and/or hand, the electrical stimulation is applied to the medial, ulnar and radial nerves individually or the brachial plexus, or a combination thereof,   wherein when the pain is associated with a medical procedure and/or trauma to the ankle and/or foot, the electrical stimulation is applied to the tibial, peroneal/sural or saphenous nerves, or a combination thereof,   wherein when the pain is associated with a hip arthroplasty, the electrical stimulation is applied to the femoral, sciatic, or obturator nerves or plexus, or a combination thereof,   wherein when the pain is associated with repair of the anterior cruciate ligament (ACL), the electrical stimulation is applied to the femoral or sciatic nerve, or a combination thereof.   
     
     
         8 . The method of  claim 1 , wherein the pain is neuropathic pain or chronic pain, the electrical stimulation is used to provide an on-demand bolus of therapeutic treatment. 
     
     
         9 . The method of  claim 1 , wherein the step of positioning the electrical stimulation device proximate the treatment site comprises:
 positioning the electrode percutaneously through an opening in the patient's skin such that the distal electrical contact is adjacent the nervous system structure; or   delivering an initial electrical stimulation to the treatment site via the electrode;   measuring at least one of a voltage or a current at the electrode; and   adjusting a position of the electrode at the treatment site until the measured voltage and current correspond to a threshold voltage and a threshold current, respectively.   
     
     
         10 . The method of  claim 1 , wherein the step of positioning the electrical stimulation device proximate the treatment site further comprises:
 delivering an initial electrical stimulation to the treatment site via the electrode;   measuring at least one of a voltage or a current at the electrode; and   adjusting a position of the electrode at the treatment site until the measured voltage and current corresponding to a threshold voltage and a threshold current, respectively.   
     
     
         11 . The method of  claim 1 , further comprising:
 adjusting at least one parameter of the electrical stimulation to selectively inhibit nerve signal transmission through the targeted neural- and non-neural tissue, wherein the at least one parameter is selected from the group consisting of a waveform shape, a waveform frequency, a waveform amplitude, waveform envelope duration, an electrical field strength generated at the electrode, a waveform DC offset, a waveform duty cycle, a tissue temperature, a cooling mechanism parameter, and a treatment duration.   
     
     
         12 . The method of  claim 1 , further comprising:
 modulating the duty cycle and/or waveform envelope duration of the electrical stimulation in real-time to maximize voltage delivered to the treatment site while not exceeding a target tissue temperature at the treatment site.   
     
     
         13 . The method of  claim 1 , further comprising:
 modulating the duty cycle and/or waveform envelope duration of the electrical stimulation in real-time to maximize current delivered to the treatment site while not exceeding a target tissue temperature at the treatment site.   
     
     
         14 . The method of  claim 1 , further comprising: slowly ramping a stimulation amplitude of the electrical stimulation to an amplitude plateau. 
     
     
         15 . The method of  claim 1 , further comprising:
 adjusting the controller to vary the electrical stimulation based on a measured feedback selected from the group consisting of: measured inhibition of nerve signal transmission, measured temperature, input from the patient, a feedback corresponding to at least one of the adjustable parameters, a treatment setting associated with a time-course of recovery, electrode contact impedance, electric field generated in the tissue, patient physiological response, and a combination thereof.   
     
     
         16 . The method of  claim 1 , wherein the electrode comprises a first and second electrode that operate independently,
 wherein delivering an electrical stimulation to the treatment site via the electrode further comprises delivering a first electrical simulation via the first electrode and delivering a second electrical stimulation via the second electrode, where the first and second electrical stimulations are intermittently outputted, where the first electrical stimulation is interleaved with respect to the second electrical stimulation such that an on cycle of the first electrical stimulation occurs during an off cycle of the second electrical stimulation and an on cycle of the second electrical stimulation occurs during an off cycle of the first electrical stimulation.   
     
     
         17 . The method of  claim 1 , further comprising:
 measuring, at a temperature sensor, a temperature of at least one of a contact surface of the stimulation device or the patient's tissue adjacent the contact surface, during delivery of the electrical stimulation, wherein the temperature sensor provides thermal feedback information regarding a measured temperature to the stimulation device, and   adjusting the electrical stimulation in response to the thermal feedback information received from the temperature sensor to create a cooling effect at least one of the contact surface of the stimulation device or the patient's tissue adjacent the contact surface.   
     
     
         18 . The method of  claim 1 , further comprising:
 measuring, at a temperature sensor, a temperature of at least one of a contact surface of the stimulation device or the patient's tissue adjacent the contact surface, during delivery of the electrical stimulation, wherein the temperature sensor provides thermal feedback information regarding a measured temperature to the stimulation device,   adjusting the electrical stimulation in response to the thermal feedback information received from the temperature sensor to adjust the temperature of the at least one of the contact surface of the stimulation device or the patient's tissue adjacent the contact surface to maintain the temperature of the patient's tissue below a destructive tissue temperature.   
     
     
         19 . The method of  claim 1 , further comprising:
 measuring, at a temperature sensor, a temperature of at least one of a contact surface of the stimulation device or the patient's tissue adjacent the contact surface, during delivery of the electrical stimulation, wherein the temperature sensor provides thermal feedback information regarding the measured temperature to the stimulation device;   activating a cooling mechanism to cool the contact surface of the stimulation device in response to the thermal feedback information received from the temperature sensor, where cooling the contact surface prevents damage to the patient's tissue when the electrical stimulation is delivered by preserving temperatures of the patient's tissue below a destructive tissue temperature; and   activating the cooling mechanism to maintain the temperature of the contact surface of the stimulation device below the destructive tissue temperature in response to thermal feedback information regarding the measured temperature received from the temperature sensor.   
     
     
         20 . The method of  claim 1 , wherein the distal electrical contact is adjacent a distal end of the elongated body of the electrode and the proximal electrical contact is located along the elongated body at a location between the distal electrical contact and a proximal end of the electrode,
 wherein the distal end of the elongated body includes a bend such that a distal tip portion of the elongated body extends at a predefined non-zero degree angle with respect to a longitudinal axis of the elongated body,   wherein the distal electrical contact is provided along the elongated body between the distal tip portion and the proximal end of the electrode.