Hyperspectral technology for assessing and treating diabetic foot and tissue disease

Abstract

This invention relates generally to an index map comprising both pressure and perfusion information from a diabetic patient foot for the purpose of treatment. The index map may also be a map of perfusion and/or metabolism of the tissue (reflecting oxygen delivery and oxygen extraction, obtained by thermal imaging, hyperspectral imaging, or duplex ultrasound, MRA, CT or laser Doppler imaging. This information aids treatment in prevention of diabetic foot ulceration and amputation and in treatment of tissue compromise to prevent tissue loss in other body regions.

1 - 57 . (canceled) 
     
     
         58 . A method for designing a prosthetic or orthotic device for treatment of a tissue of a subject, the method comprising:
 (A) obtaining a gradient map of the tissue of the subject, wherein the gradient map comprises information about tissue oxygenation, tissue oxygen extraction, tissue metabolism, or tissue perfusion of the tissue;   (B) determining a pressure or stress applied to the tissue;   (C) identifying one or more areas of the tissue that are at risk for disease formation or disease progression based on the gradient map, or the pressure or stress applied to the tissue; and   (D) designing the prosthetic or orthotic device to redistribute the pressure or stress across the tissue, wherein the redistribution of the pressure or stress across the tissue reduces the pressure or the stress applied to the one or more identified areas of the tissue that are at risk for disease formation or disease progression.   
     
     
         59 . The method of  claim 58 , wherein the gradient map of the tissue of the subject is a hyperspectral image. 
     
     
         60 . The method of  claim 58 , wherein the gradient map of the tissue of the subject is paired with a spatial map of the pressure or stress applied to the tissue to form a composite image, wherein the identifying of the one or more areas of the tissue that are at risk for disease formation or disease progression is based on the composite image. 
     
     
         61 . The method of  claim 58 , wherein the pressure or stress applied to the tissue comprises pressure or stress exerted by the prosthetic or orthotic device. 
     
     
         62 . The method of  claim 58 , wherein an area in the one or more areas of the tissue at risk for disease formation or disease progression is an area of the tissue at risk for ulceration. 
     
     
         63 . The method of  claim 58 , wherein the one or more identified areas of the tissue that are at risk for disease formation or disease progression are areas with low tissue oxygenation or oxygen saturation, or areas with high pressure. 
     
     
         64 . The method of  claim 58 , wherein the tissue is located on a toe, a foot, a leg, a finger, a hand, or an arm of the subject. 
     
     
         65 . The method of  claim 58 , wherein the redistribution of the pressure or stress across the tissue minimizes the pressure to the one or more identified areas of the tissue that are at risk for disease formation or disease progression. 
     
     
         66 . The method of  claim 58 , wherein the redistribution of the pressure or stress across the tissue reduces the pressure or the stress applied to the one or more identified areas of the tissue that are at risk for disease formation or disease progression to substantially zero. 
     
     
         67 . The method of  claim 58 , wherein the redistribution of the pressure or stress across the tissue reduces the pressure or the stress applied to the one or more identified areas of the tissue that are at risk for disease formation or disease progression to less than zero. 
     
     
         68 . The method of  claim 58 , wherein the designing of the prosthetic or orthotic device comprises:
 modifying the prosthetic or orthotic device to maximize tissue oxygenation, tissue metabolism or tissue perfusion of the tissue.   
     
     
         69 . The method of  claim 58 , wherein the designing of the prosthetic or orthotic device comprises:
 creating a prosthetic, orthotic or cushioned surface to protect the one or more identified areas of the tissue that are at risk for disease formation or disease progression.   
     
     
         70 . The method of  claim 58 , wherein the tissue is located on a foot of the subject, wherein the designing of the prosthetic or orthotic device comprises:
 optimizing a footwear to reduce the pressure or stress applied to the one or more identified areas of the tissue that are at risk for disease formation or disease progression.   
     
     
         71 . The method of  claim 58 , wherein the tissue is located on a foot of the subject, wherein the designing of the prosthetic or orthotic device comprises:
 creating an insole made of a higher density plastic or rubber material with a lower density foam or polymer at one or more sites corresponding to the one or more identified areas of the tissue that are at risk for disease formation or disease progression.   
     
     
         72 . The method of  claim 71 , wherein the insole further comprises one or more silicone gel or fluidic pockets at the one or more sites corresponding to the one or more identified areas of the tissue that are at risk for disease formation or disease progression. 
     
     
         73 . The method of  claim 58 , wherein the gradient map of the tissue of the subject and the pressure or stress applied to the tissue are obtained without the prosthetic or orthotic device placed on the tissue of the subject. 
     
     
         74 . The method of  claim 73 , further comprising:
 (E) repeating (A), (B) and (C) with the prosthetic or orthotic device placed on the tissue of the subject; and   (F) modifying the prosthetic or orthotic device to optimize the distribution of the pressure or stress across the tissue, or to maximize tissue oxygenation, tissue metabolism or tissue perfusion of the tissue.   
     
     
         75 . The method of  claim 74 , wherein the modification of the prosthetic or orthotic device comprises altering a structure of the prosthetic device. 
     
     
         76 . The method of  claim 74 , wherein the modification of the prosthetic or orthotic device comprises adding or removing cushioning material.