Article and method for treating diabetic peripheral neuropathy

Abstract

A system for percutaneously applying electrical stimulation to target nerve tissue to treat a patient having peripheral neuropathy includes a percutaneous electrode assembly, a power supply, and a pulse generator electrically coupled to the percutaneous electrode assembly and the power supply, the pulse generator configured to deliver electrical stimulation to the target nerve tissue via the percutaneous electrode assembly at a level that initiates vasodilation of vasculature within or adjacent the target nerve tissue, where the vasculature is responsible for perfusing the target nerve tissue and the electrical stimulation is delivered with a carrier frequency in the range of 25 kHz to 500 kHz.

What is claimed is: 
     
         1 . A system for percutaneously applying electrical stimulation to target nerve tissue to treat a patient having peripheral neuropathy, the system comprising:
 a percutaneous electrode assembly;   a power supply; and   a pulse generator electrically coupled to the percutaneous electrode assembly and the power supply, the pulse generator configured to deliver electrical stimulation to the target nerve tissue via the percutaneous electrode assembly at a level that initiates vasodilation of vasculature within or adjacent the target nerve tissue, wherein the vasculature is responsible for perfusing the target nerve tissue, wherein the electrical stimulation is delivered with a carrier frequency in the range of 25 kHz to 500 kHz.   
     
     
         2 . The system of  claim 1 , wherein the percutaneous electrode assembly comprises one or more implantable electrodes having a diameter ranging from 0.25 mm to 10 mm. 
     
     
         3 . The system of  claim 2 , wherein the one or more implantable electrodes comprise at least two electrodes having varying impedances. 
     
     
         4 . The system of  claim 2 , wherein each of the one or more implantable electrodes comprise an internal lumen for delivering a fluid therethrough. 
     
     
         5 . The system of  claim 4 , wherein each of the one or more implantable electrodes comprise one or more openings that extend from the internal lumen to an outer surface of a corresponding one of the one or more implantable electrodes such that the fluid can be dispelled from the corresponding one of the one or more implantable electrodes through the one or more openings. 
     
     
         6 . The system of  claim 1 , wherein the pulse generator and the power supply are implantable. 
     
     
         7 . The system of  claim 1 , wherein the peripheral neuropathy is diabetic peripheral neuropathy. 
     
     
         8 . The system of  claim 1 , wherein the target nerve tissue is located within or adjacent a peripheral nerve. 
     
     
         9 . The system of  claim 1 , wherein the target nerve tissue is located within a foot, a hand, a distal phalanx of a toe, a distal phalanx of a finger, or a combination thereof. 
     
     
         10 . The system of  claim 1 , wherein the system is configured to initiate vasodilation of resistance-sized blood vessels having a lumen diameter of less than 400 micrometers. 
     
     
         11 . The system of  claim 1 , wherein the system relieves pain caused by the peripheral neuropathy or facilitates recovery of a loss of sensation resulting from the peripheral neuropathy. 
     
     
         12 . The system of  claim 1 , wherein the pulse generator is configured to deliver the electrical stimulation at a frequency ranging from about 0.1 Hertz to about 200 Hertz. 
     
     
         13 . The system of  claim 1 , wherein the pulse generator is configured to deliver the electrical stimulation at a current ranging from about 0.1 milliamps to about 60 milliamps or at a voltage ranging from 0.1 volts to about 200 volts. 
     
     
         14 . The system of  claim 1 , wherein the pulse generator is configured to deliver the electrical stimulation as a series of pulses each having a pulse width ranging from about 0.1 milliseconds to about 250 milliseconds. 
     
     
         15 . A method for percutaneously applying electrical stimulation to target nerve tissue to treat a patient having peripheral neuropathy, the method comprising:
 positioning an electrode assembly on, or adjacent to, the target nerve tissue; and   delivering electrical stimulation to the target nerve tissue via the electrode assembly, wherein:
 the electrical stimulation is delivered at a level sufficient to initiate vasodilation of vasculature within or adjacent the target nerve tissue, 
 the vasculature is responsible for perfusing the target nerve tissue, and 
 the electrical stimulation is delivered with a carrier frequency in the range of 25 kHz to 500 kHz. 
   
     
     
         16 . The method of  claim 15 , wherein the electrode assembly comprises one or more implantable electrodes having a diameter ranging from 0.25 mm to 10 mm. 
     
     
         17 . The method of  claim 15 , wherein the one or more electrode assembly comprise at least two percutaneous electrodes having varying impedances. 
     
     
         18 . The method of  claim 15 , wherein the electrical stimulation is delivered at a frequency ranging from about 0.1 Hertz to about 200 Hertz. 
     
     
         19 . The method of  claim 15 , wherein the electrical stimulation is delivered at a current ranging from about 0.1 milliamps to about 60 milliamps or at a voltage ranging from 0.1 volts to about 200 volts. 
     
     
         20 . The method of  claim 15 , wherein the electrical stimulation is delivered as a series of pulses each having a pulse width ranging from about 0.1 milliseconds to about 250 milliseconds.