Peripheral sensory and supersensory replacement system

Abstract

A sensor-based quantification and analysis system includes an input device including a plurality of sensors that generate an input based on a force. The input device also includes a transmission device that transmits force information based on the input. The system also includes an output device that receives the force information. A processing unit selects, for each of the plurality of sensors, one of a plurality of levels of a likelihood of tissue damage based on the force and a predetermined time period. Further, the output device includes a display that presents or logs the one of the plurality of levels of the likelihood of tissue damage for each of the plurality of sensors.

We claim: 
     
         1 . A sensory substitution insole for management of peripheral neuropathy, comprising:
 an insole bulk having a set of functional unit areas;   a pressure sensing array embedded in the insole bulk and comprising a plurality of pressure sensors that are configured to measure pressure over a plantar surface of a user's foot and generate pressure measurements, wherein each of the functional unit areas has at least one of the pressure sensors located therein;   a processing unit embedded in the insole bulk and in communication with the pressure sensors for receiving the pressure measurements from the pressure sensors, wherein the processing unit is configured to compare the pressure measurements to a pressure threshold and generate a pressure alert signal for each functional unit area based on the comparison; and   a wireless transmission node embedded in the insole bulk and in communication with the processing unit for transmitting the pressure alert signals out of the insole to alert the user of a risk of tissue damage in each of the functional unit areas.   
     
     
         2 . The sensory substitution insole of  claim 1 , wherein for each functional unit area, the processing unit is configured to determine a percentage of the pressure measurements that exceed the pressure threshold within a predetermined time period, and wherein the pressure alert signal is selected based on the percentage. 
     
     
         3 . The sensory substitution insole of  claim 1 , wherein the insole bulk comprises an upper surface layer and a lower cushion layer, and the plurality of pressure sensors is laminated between the upper surface layer and the lower cushion layer. 
     
     
         4 . The sensory substitution insole of  claim 1 , wherein the functional unit areas comprise at least at least one of a heel area, a toe area, a lateral side area, and an MTP joint area. 
     
     
         5 . The sensory substitution insole of  claim 1 , wherein the functional unit areas comprise at least a heel area, a toe area, and an MTP joint area. 
     
     
         6 . The sensory substitution insole of  claim 1 , wherein each of the pressure sensors generates pressure measurements at a measurement frequency of at least 4 Hz. 
     
     
         7 . The sensory substitution insole of  claim 1 , further comprising at least one temperature sensor embedded in the insole bulk for generating temperature measurements, wherein the processing unit is in communication with the temperature sensor for receiving the temperature measurements and is configured to generate a temperature alert signal based on the temperature measurements. 
     
     
         8 . The sensory substitution insole of  claim 7 , wherein the wireless transmission node is configured to transmit the temperature alert signal out of the insole to alert the user of impending tissue ulceration. 
     
     
         9 . The sensory substitution insole of  claim 1 , wherein the processing unit is further configured to count the user's steps. 
     
     
         10 . The sensory substitution insole of  claim 1 , wherein the processing unit is further configured to monitor a duration of the user's use of the sensory substitution insole. 
     
     
         11 . The sensory substitution insole of  claim 1 , wherein the processing unit is further configured to monitor a duration of pressure measurements above the pressure threshold during use. 
     
     
         12 . The sensory substitution insole of  claim 1 , wherein the processing unit is further configured to monitor a duration of pressure measurements below the pressure threshold during use. 
     
     
         13 . A method for fabricating a sensory substitution insole, comprising
 a. based on an analysis of a user's foot, custom fashioning an insole bulk to support the user's foot;   b. embedding a pressure sensing array in the insole bulk, wherein the pressure sensing array comprises a plurality of pressure sensors that are configured to measure pressure over a plantar surface of the user's foot and generate pressure measurements;   c. embedding a processing unit in the insole bulk, wherein the processing unit is in communication with the pressure sensors for receiving the pressure measurements from the pressure sensors and generating pressure alert signals;   d. embedding a wireless transmission node embedded in the insole bulk, wherein the wireless transmission node is in communication with the processing unit for transmitting the pressure alert signals out of the insole.   
     
     
         14 . The method of  claim 13 , wherein step a. comprises custom fashioning an upper surface layer. 
     
     
         15 . The method of  claim 14 , wherein step b. comprises laminating the pressure sensing array between the upper surface layer and a lower cushion layer. 
     
     
         16 . The method of  claim 13 , wherein
 step a. comprises fashioning the insole bulk to have a set of functional unit areas; and   step b. comprises embedding at least one of the pressure sensors in each of the functional unit areas.   
     
     
         17 . The method of  claim 13 , further comprising embedding at least one temperature sensor in the insole bulk, wherein the at least one temperature sensor is in communication with the processing unit. 
     
     
         18 . The method of  claim 13 , further comprising configuring the processing unit to determine a percentage of the pressure measurements that exceed a pressure threshold within a predetermined time period, and to select the pressure alert signals based on the percentage. 
     
     
         19 . The method of  claim 13 , further comprising configuring the processing unit to count the user's steps. 
     
     
         20 . The method of  claim 13 , further comprising configuring the pressure sensors to generate pressure measurements at a measurement frequency of at least 4 Hz.