Method and apparatus for noninvasive inhibition of deep vein thrombosis

Abstract

System, device and method for providing neuromuscular electrical stimulation (NMES) to muscles of foot. The device includes an electrical signal generator for producing a wave pattern of variable frequency, duration, intensity, ramp time and on-off cycle. The device further includes surface electrodes for being positioned over the foot muscles or around ankles and attached to the signal generator. The device includes a wearable device for positioning a first electrode adjacent a heel of the wearer's foot and a second electrode adjacent an arch of the foot. The signal generator is programmed to stimulate the foot muscles and nerves. Location of the electrodes and the programming are adjusted to reduce pooling of the blood in the soleal veins of the calf and enhance venous blood flow to prevent deep vein thrombosis (DVT); to enhance venous blood flow for the post-thrombotic syndrome patient; to expedite wound healing; to reduce neuropathic pain of the foot and ankle, chronic musculoskeletal pain of the ankle and foot, and acute post-operative foot and ankle pain; and to prevent muscular atrophy of the foot muscles.

What is claimed is: 
     
         1 . A device for delivering electrical stimulation to muscles of a foot of a patient, the device comprising:
 a signal generator for generating a stimulation waveform configured to cause the muscles of the foot to contract, the signal generator comprising a first power source for generating the stimulation waveform; and   two electrodes comprising a ground electrode and a positive electrode, the two electrodes configured for delivery of an electrical current to the foot according to the stimulation waveform generated by the signal generator, at least one of the two electrodes comprising a second power source for generating the electrical current, the at least one electrode being in wireless communication with the signal generator for receiving the stimulation waveform from the signal generator,   wherein the two electrodes are joined by an electrical connector extending between the two electrodes for creating a closed circuit with the body and configured to locate the two electrodes adjacent to one another on a sole of the foot or on an ankle of the patient.   
     
     
         2 . The device of  claim 1 , further comprising:
 an input and output interface for receiving input parameters for programming the device and echoing current parameters to a user;   a processor for controlling the electrical current generated by the signal generator according to the input parameters; and   a storage medium in communication with the processor and the input and output interface for storing the input parameters.   
     
     
         3 . The device of  claim 2 , wherein the input parameters are received from the user, from a monitoring device for monitoring the patient, from the patient or from any combination. 
     
     
         4 . The device of  claim 2 , wherein the input parameters are adjusted to enhance venous blood flow to prevent deep vein thrombosis, enhance venous blood flow for the post-thrombotic syndrome patients, and prevent muscular atrophy of the foot muscles. 
     
     
         5 . The device of  claim 1 , wherein the signal generator is a single channel sequential neuromuscular electrical stimulation (NMES) device. 
     
     
         6 . The device of  claim 1 ,
 wherein the electrical current delivered is in the form of a biphasic symmetrical square wave,   wherein the square wave has a frequency of substantially equal to 50 pulses per second, and   wherein the electrical current delivered has an intensity of up to 20 milliamperes.   
     
     
         7 . The device of  claim 1 , wherein the electrical current is in the form of a pulse with a ramp up time of substantially equal to 2 seconds and a ramp down time of substantially equal to 2 seconds. 
     
     
         8 . The device of  claim 1 , further comprising:
 an accelerometer in communication with the signal generator,   wherein the signal generator ceases to generate the stimulation waveform if the accelerometer communicates movement of the patient and restarts to generate electrical current after a pre-programmed period of inactivity by the patient is communicated by the accelerometer.   
     
     
         9 . A method for enhancing venous blood flow to prevent deep vein thrombosis, enhancing venous blood flow for post-thrombotic syndrome patients, and preventing muscular atrophy of foot muscles, the method comprising:
 applying two electrodes comprising a positive electrode and a ground electrode to a foot of a patient or an ankle of the patient, the two electrodes configured for delivery of an electrical current to the foot, at least one of the two electrodes comprising a first power source for generating the electrical current, the at least one electrode being in wireless communication with a signal generator comprising a second power source, wherein the two electrodes are joined by an electrical connector extending between the two electrodes for creating a closed circuit with the body;   generating with the signal generator a stimulation waveform of a programmable intensity, frequency, and duration, the waveform configured to cause the muscles of the foot to contract;   wirelessly transmitting the stimulation waveform from the signal generator to the at least one electrode in wireless communication with the signal generator; and   applying an electrical current according to the wirelessly transmitted stimulation waveform to the foot muscles through the two electrodes, the two electrodes forming a closed circuit with the body of the patient.   
     
     
         10 . The method of  claim 9 , wherein the electrical current is adjusted responsive to condition of the patient. 
     
     
         11 . The device of  claim 1 , wherein the two electrodes are adapted to be located on a heel of the foot and on an arch of the foot. 
     
     
         12 . The device of  claim 1 , wherein the two electrodes are adapted to be located on two or more of the medial ankle at a location of the posterior tibial nerve, the lateral ankle at a location of the sural nerve, and the anterior ankle at a location of the anterior tibial nerve. 
     
     
         13 . The device of  claim 1 , wherein the signal generator is configured to be remotely programmed by a physician. 
     
     
         14 . The method of  claim 9 , wherein applying the two electrodes comprises applying the two electrodes to a sole of the foot. 
     
     
         15 . The method of  claim 13 , wherein applying the two electrodes comprises applying the positive electrode to an arch of the foot and applying the ground electrode to a heel of the foot. 
     
     
         16 . A device for delivering electrical stimulation to muscles of a foot of a patient, the device comprising:
 a footwear item configured to be worn over the foot of the patient;   one or more power sources;   a signal generator for generating electrical current; and   at least two electrodes carried by the footwear item and in communication with the signal generator for delivery of the electrical current to the foot,   wherein the electrical current is configured for causing the muscles of the foot to contract, and   wherein the at least two electrodes are adapted to be located by the footwear item on a heel of the foot and on an arch of the foot.   
     
     
         17 . The device of  claim 16 , further comprising:
 an input and output interface for receiving input parameters for programming the device and echoing current parameters to a user;   a processor for controlling the electrical current generated by the signal generator according to the input parameters; and   a storage medium in communication with the processor and the input and output interface for storing the input parameters.   
     
     
         18 . The device of  claim 17 , wherein the input parameters are received from the user, from a monitoring device for monitoring the patient, from the patient or from any combination. 
     
     
         19 . The device of  claim 17 , wherein the input parameters are adjusted to enhance venous blood flow to prevent deep vein thrombosis, enhance venous blood flow for the post-thrombotic syndrome patients, and prevent muscular atrophy of the foot muscles. 
     
     
         20 . The device of  claim 16 , wherein the one or more power sources are proximal to the signal generator, the device further comprising:
 conductors coupled between the electrodes and the signal generator for delivering the electrical current from the signal generator to the electrodes.   
     
     
         21 . The device of  claim 16 , wherein the signal generator is a single channel sequential neuromuscular electrical stimulation (NMES) device. 
     
     
         22 . The device of  claim 16 ,
 wherein the electrical current delivered is in the form of a biphasic symmetrical square wave,   wherein the square wave has a frequency of substantially equal to 50 pulses per second, and   wherein the electrical current delivered has an intensity of up to 20 milliamperes.   
     
     
         23 . The device of  claim 16 , wherein the electrical current is in the form of a pulse with a ramp up time of substantially equal to 2 seconds and a ramp down time of substantially equal to 2 seconds. 
     
     
         24 . The device of  claim 16 , further comprising:
 an accelerometer in communication with the signal generator,   wherein the signal generator ceases to generate the electrical current if the accelerometer communicates movement of the patient and restarts to generate electrical current after a pre-programmed period of inactivity by the patient is communicated by the accelerometer.   
     
     
         25 . A method for enhancing venous blood flow to prevent deep vein thrombosis, enhancing venous blood flow for post-thrombotic syndrome patients, and preventing muscular atrophy of foot muscles, the method comprising:
 connecting electrodes to a foot of the patient, and   applying electrical current of a programmable waveform, intensity, frequency and duration to the foot muscles through the electrodes,   wherein connecting electrodes to the foot of the patient comprises connecting a ground electrode to a heel of the foot and connecting a positive electrode to an arch of the foot.   
     
     
         26 . The method of  claim 25 , wherein the electrical current is adjusted responsive to condition of the patient.