Abstract:
A device monitors circumferences of the leg, and estimates volume of a section of the leg, to detect edema, which can be indicative of CHF, and gauge the effectiveness of medication. The device sends the calculations to a database via BLUETOOTH™ for the patient&#39;s treating medical personnel to see.

Description:
RELATED APPLICATIONS 
       [0001]    The present application is related to and claims priority to U.S. Provisional Patent Application Ser. No. 62/025,636, filed on Jul. 17, 2014. The subject matter disclosed in that provisional application is hereby expressly incorporated into the present application in its entirety. 
     
    
     FIELD 
       [0002]    The present invention is in the field of electronic measurement of anatomical areas. More particularly, the present invention is in the field of measuring monitoring edema. 
       BACKGROUND 
       [0003]    Congestive Heart Failure (CHF) is a condition in which the heart does not sufficiently pump blood to and from the organs of the body. The American Heart Association estimates that there are approximately five million Americans living with CHF, and there are approximately 53,000 deaths due to CHF each year, making it one of the most significant public health burdens in the United States. As blood is pumped progressively less effectively due to CHF, fluid can aggregate in the peripherally, in the extremities, causing edema, also known as swelling. As peripheral edema increases, so does the volume of the leg. To treat the symptoms of swelling, medications that cause the body to excrete more fluid, and thus reduce the buildup of fluid and subsequent swelling, can be administered. The effectiveness of the medication can be gauged, and its dosages adjusted, by regular monitoring of the volume of the leg. 
         [0004]    Monitoring for the presence of CHF and quantification of fluid retention in the peripheral extremities is currently accomplished by cumbersome methods. One such method involves wrapping a tape measure around the same part of the leg one or more times per day and measuring the circumference, noting any changes, and reporting the results to the patient&#39;s treating doctor. As the volume of a section of the leg increases, there is a proportional increase in the area and circumference of a circle circumscribed around it. Because circumference is linearly proportional to length, the change in length is linearly proportional to the change in circumference. Thus, the change in volume can be estimated by monitoring the change in length of circumscription around a particular location of the leg. Compliance with this method can be low, and obtained results can be inaccurate. Another method of monitoring leg volume is accomplished by filling a bucket with water, and having the patient place his leg in the bucket. The volume of water displaced is equal to the volume of the leg. This volume is measured, and the results are reported to the patient&#39;s treating doctor. Again, the cumbersome nature of this method can cause low patient compliance in monitoring leg volume, and can also lead to inaccurate results. Thus, there exists deficiency in the current monitoring methods. 
       SUMMARY 
       [0005]    Thus, conventional equipment is cumbersome, can be challenging to comply with, and are conducive to inaccurate measurements. Further, there exists no device or system for the automated calculation of circumference of the leg, and estimation of leg volume. The above problems, as well as other problems which include patient compliance, may be solved by various aspects of the disclosed embodiment of a device for detecting presence and severity of edema. 
         [0006]    Disclosed embodiments may implement an electronic method of calculating circumference the foot and part of the leg, and estimating volume of the foot and part of the leg. When the device, which fits around the leg like a sock, may be worn by the patient, it automatically measures the circumference reading at multiple points. The results may be sent via BLUETOOTH™ to a device that can relay the transmission to a database for the patient&#39;s treating doctor to monitor. In another version of this device and implementation, the circumferences obtained may be used to generate a three-dimensional model of the foot and leg, and in conjunction with parameters based on basic patient information, an estimate for the volume may be generated. 
         [0007]    Additional features of the present disclosure will become apparent to those skilled in the art upon consideration of illustrative embodiments exemplifying the best mode of carrying out the disclosure as presently perceived. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]      FIG. 1A  is a front view of the brace that may be worn around the leg. 
           [0009]      FIG. 1B  is a side view of the brace that may be worn around the leg. 
           [0010]      FIG. 2  is a block diagram of the signal acquisition and transmission hardware in combination with a mobile computing unit for displaying the circumferences calculated. 
           [0011]      FIG. 3  is a diagram of the process to calculate circumference. 
           [0012]      FIG. 4  is a flowchart of a process of determining a volume of a foot. 
       
    
    
     DETAILED DESCRIPTION 
       [0013]      FIG. 1A  and  FIG. 1B  show one embodiment of the disclosed invention wherein a stretchable material may be worn like a brace  100  and include a foot portion  101  and an leg portion that may be worn on a user&#39;s leg. The brace foot portion  101  and the brace leg portion  103  may be connected by a common piece of fabric  105  that may be positioned on the back of the user&#39;s leg. In some embodiments, the brace  100  may be a sock worn on the foot. 
         [0014]    There may be three or more stretchable wires whose electrical resistance increases in linear proportion with length  104 ,  114 ,  115  that form circumferences around the brace leg portion  103 , and may be sewn into it. Connective wires  106 ,  107  may be connected to each end of the top stretchable wire  104 , and both connective wires  106 ,  107  may be connected to two poles of one of a voltmeter (not shown) included in the microcontroller  302  (as illustrated in  FIG. 1B ). Connective wires  108 ,  109  may be connected to each end of the middle stretchable wire  114 ; both connective wires  108 ,  109  may be connected to two poles of the voltmeter (not shown) in the microcontroller  302 . Connective wires  110 ,  111  may be connected to each end of the bottom stretchable wire  115 ; both connective wires  110 ,  111  may be connected to two poles of the voltmeter (not shown) in the microcontroller  302 . Similarly, in the foot brace  101 , stretchable wire whose electrical resistance changes in linear proportion to length  102  may be sewn into the brace, forming a figure eight, e.g., wherein two circumferences around the foot brace. The wire  102  crosses over itself at the top of the foot brace. 
         [0015]    As illustrated in  FIG. 2 , signal and transmission hardware  301  may include a coin cell battery  303  coupled to other components illustrated therein to provide power to the signal acquisition and transmission hardware  301 . A push button  304  on the signal acquisition and transmission hardware  301  may be depressed to power components included in the brace  100 . Microcontroller  302  may be in communication with the push button  304 , battery  303 , an analog to digital converter  306 , and a radio transmission device  305 . 
         [0016]    Further, microcontroller  302  may be connected to the coin cell battery  303  or another power source (not shown) to provide a current fed through the wires  102 ,  104 ,  114 ,  115  to determine a resistance indicative of lengths of wire in the brace (as explained in detail below). Thus, it should be understood that the current fed through the wires  102 ,  104 ,  114 ,  115  may be injected on a limited basis when the brace  100  is operable to determine the resistance indicative of those lengths. Thus, when the microcontroller  302  receives a signal from the pushbutton  304  to acquire signals across the stretchable wires,  102 ,  104 ,  114 ,  115 , an electrical current of known value may be passed through each of the stretchable wires  102 ,  104 ,  114 ,  115 . 
         [0017]    As a result, a voltage exists in each stretchable wires  102 ,  104 ,  114 ,  115  because of the current being passed through the stretchable wires. The resulting analog voltage value may be optionally stored and also converted by an analog-to-digital converter  306  and then may be input to the microcontroller  302 . The voltage of each of the wires  102 ,  104 ,  114 ,  115  may be one or more voltmeters in the microcontroller  302  (e.g., an implementation including a single voltmeter may measure the voltages sequentially, whereas an implementation with a plurality of voltmeters may measure the voltages simultaneously). 
         [0018]    In some embodiments, microcontroller  302  may include a processor and memory with instructions, that when executed cause the processor to calculate circumferences for the stretchable wires and corresponding volumes as described with respect to  FIGS. 4-5  below. 
         [0019]    As seen in  FIG. 2 , the brace foot portion  103  of  FIGS. 1A-1B  may be in wireless communications with a mobile computing unit  401  for displaying and transmitting data received from the microcontroller. All calculated circumference and volume values may be transmitted via a BLUETOOTH™ radio  305  connection to a mobile computing unit  401 , which can be a smartphone or a dedicated device. The mobile computing unit can transmit the results via internet connection to the treating medical personnel. 
         [0020]    As seen in  FIG. 3 , the device can be configured to execute a process that is based on Ohm&#39;s Law. Thus, the process being at  301  and control proceeds to  303  at which a voltage is detected for one or more of the wires  102 ,  104 ,  114 ,  115 . Control then proceeds to  305 , at which the resistance appearing on the respective wire is determined since the injected current and detected voltage are known. Ohm&#39;s Law dictates that Voltage, V, is equal to current, i, multiplied by resistance, R, i.e., V=iR. 
         [0021]    Furthermore, it is known that the resistance of a wire increases in linear proportion to the increase in length of the wire. Thus, for example, with reference to wires  102 ,  104 ,  114 ,  115 , each wire&#39;s resistance may be 350 Mega Ohms per inch. Thus, theoretically, if the length of one of these wire increases by one inch, the total resistance of that wire will increase by 350 Mega Ohms as well (which may be referred to as a “stretch constant.” 
         [0022]    Likewise, if the length of that wire increases by two inches, the total resistance of the wire will increase by 700 Mega Ohms. Accordingly, if a change in voltage increases by 350 Mega Ohms, the resistance determined will be indicative of a baseline resistance output (corresponding to an unstretched circumference of the wiring) plus one inch. 
         [0023]    Accordingly, at  307 , the total length of the stretchable wire(s) is determined and used to determine the total volume of the leg on which the brace  100  is attached. This data may be output from the microcontroller, e.g., transmitted via to a mobile computing unit for subsequent display and use. 
         [0024]    In other words, because a wire has an intrinsic property of resistance per length, R 1 /l, the microcontroller and disclosed inventive process can use resistance R of one of the stretchable wires,  102 ,  104 ,  114 ,  115 , and equate it to resistance per length, R 1 /l, a known value, multiplied by total length of the wire. Thus, resistance per length multiplied by total length of the wire may be used to represent the total resistance in Ohm&#39;s Law. The only unknown variable may be total length of the wire, which represents the circumference. This variable can be isolated and solved for. The device computes this value from each of the wires  102 ,  104 ,  114 ,  115 . 
         [0025]      FIG. 4  shows one implementation of a process to approximate the volume for user&#39;s leg under direction of a microcontroller. First, analog to digital conversion of voltage measured across a plurality of stretchable wires is performed at  402 . Control then proceeds to  404 , at which the circumferential length of the stretchable wire is calculated for each wire as described in detail in relation to  FIG. 3 . Control then proceeds to  406 , at which a volume of the leg may be calculated using the calculated circumferences. As mentioned above, the volume of the leg may include the lower leg portion and/or ankle portion of the leg. 
         [0026]    Control then proceeds to  408  at which the calculated volume can be transmitted to a user and/or a remote caregiver and communicated to the user via visual and/or audible communications (e.g., on a user&#39;s mobile computing unit). 
         [0027]    In further detail, the approximate volume of the leg may be calculated by approximating the upper leg is as a cylinder. Thus, the distance (e.g., height) between each the wires for which circumference has been calculated may be constant and known. For example, the distance between the bottom wire  115  and the middle wire  114  (illustrated in  FIGS. 1A and 1B ) may be denoted “A.” The distance between the middle wire  114  and the top wire  104  (illustrated in  FIGS. 1A and 1B ) may be denoted as “B.” The distance between the top wire  104  and the top of the brace  103  on the upper leg  103  is also known. This distance is called “C.” 
         [0028]    In this example, the volume of the section of the leg covered by the brace on the upper leg may be approximated as the sum of three cylinders. It is the sum of the cylinder contained between the lowest wire  115  and the middle wire  114 ; the cylinder contained between the middle wire  114  and the upper wire  104 ; and the cylinder contained between the upper wire  114  and the top of the brace  103 . The circumference attained by the bottom wire  115  is called “D.” The circumference attained by the middle wire  114  is called “E.” The circumference attained by the top wire  104  is called “F.” Mathematically, the volume approximation is represented as 
         [0000]    
       
         
           
             Volume 
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                 A 
               
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                     E 
                     2 
                   
                   
                     4 
                      
                     π 
                   
                 
                  
                 B 
               
               + 
               
                 
                   
                     F 
                     2 
                   
                   
                     4 
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                   C 
                   . 
                 
               
             
           
         
       
     
         [0029]    The ankle volume can also be calculated along with the leg volume using the ankle&#39;s circumference (for example, circumference of the “figure eight” shape of wire in  FIG. 1B ). A conversion factor to convert from figure eight circumference to volume can be provided. This conversion factor can be established before regular use of the device by comparing the figure eight circumference with ankle volume obtained with a water displacement method. The relationship between the circumference and the square root of the volume is linear. This factor can be multiplied the circumference of the figure eight obtained with regular use, to obtain volume of the ankle. 
         [0030]    This brace  100  may be utilized, for example, by a heart failure patient who is discharged from the hospital. Heart failure patients are most frequently discharged from the hospital when diuresis has been performed on them, and they have been ridden of all the extraneous fluid that usually causes peripheral edema. Thus, when a patient uses the device immediately after their edema has been eliminated, those values attained represent the baseline, or ideal volume. The results from use of the device each day can be transmitted to a remote server, where they can be compared to the baseline and trended. A trend towards an increase from the baseline is indicative of fluid retention and edema in the legs. This data can be used to guide remote titration of oral diuretics—that is, to enable care providers to suggest that patients increase the dosage of diuretics they take on a given day, to return leg volume to baseline. 
         [0031]    This sock can be used in conjunction with daily weight measurement to increase sensitivity of fluid retention monitoring. If a patient has gained 1 kilogram of weight, and the results of the device show a gain of 1 liter of volume (combined in both feet), it can be confirmed that all weight that has been gained is due exclusively to fluid retention, and not other causes of weight gain. Conversely, if a patient has gained weight, but shows no increase in volume of the legs, or shows a decrease in volume of the legs, it can be concluded that the patient&#39;s weight gain is not due to fluid retention or edema. 
         [0032]    It should further be understood that there may utility in a user wearing only a single brace on a leg to provide a representational detection and determination of bilateral edema (e.g., in both legs). Alternatively, a brace may be worn on each leg to be able to detect unilateral, sudden onset edema that may be indicative of a blood clot in the leg (i.e., a deep vein thrombosis or DVT). It should further be understood that calculations and processing described may take place at the microcontroller on the brace and/or at a remote server or remote processing device in communications with the transmission hardware on the brace. 
         [0033]    Disclosed embodiments solve a technical problem in the conventional art in that there is no conventional device that is able to measure the volume of a body part, e.g., a human leg, in a user friendly manner so as to provide up to date monitoring data indicative of edema in the user. 
         [0034]    The presently disclosed embodiment does this in an unobtrusive compact way that enables the user to maneuver and go about daily activity while still wearing the device. Thus, it should be understood that, in at least one embodiment the user may wear footwear while wearing the brace. In this way, the disclosed embodiments improve the likelihood that a user will adhere to and favorably respond to such monitoring. 
         [0035]    Thus, it should be understood that the disclosed invention contemplates a wearable device measuring changes in a body part volume, wherein the wearable device comprises a plurality of sensors that each output a signal, a source configured to generate and send a voltage to each of the plurality of sensors, a microprocessor that receives signals from each of the sensors, calculates the circumference and volume of the body part, and communicates with a remote processing unit to identify and store trends in the body part over time. In that wearable device, the plurality of sensors may comprise a plurality of stretchable wires having electrical resistances that increase in linear proportion with length. In the wearable device, the output received from each of the sensors indicates a resistance across each sensor. In that wearable device, a push button may power the system on and a Bluetooth connection to transmit the output from each of the sensors. In that wearable device, the wearable device may be a brace configured to be worn on a human leg and foot. In that wearable device, the brace may be configured to measure the volume of a lower segment of the human leg and wherein the microprocessor comprises a microcontroller configured to calculate the leg volume based on the circumference measured at each sensor and a predefined leg model. 
         [0036]    The plurality of sensors may comprise three stretchable wires attachable to a lower leg portion of a sock and forming an annular ring around a circumference of the lower leg portion of a sock. The wearable device may be a brace and may further include a wire that intersects itself configured for placement at an upper foot surface. 
         [0037]    A system for measuring changes in volume of a body part of a user may comprise a wearable device as discussed above; a transmitter configured to transmit signals generated by the plurality of sensors; and a remote processing unit configured to receive the output from the microprocessor, and identify and store trends in the human leg volume over time. 
         [0038]    A system for measuring changes in volume of a body part of a user, the system may comprise a wearable device as disclosed above, a transmitter configured to transmit signals generated by the plurality of sensors; and a processor configured to receive the signals, process the signals to determine a circumference at each of the plurality of sensors, calculate a volume of the body part based on the determined circumferences, and compare the determined volume of the body part with at least a previously determined volume to identify a change in volume of the body part. The system may further include a memory coupled to the processor, wherein the processor is configured store the determined volume and changes in volume over time in the memory. The processor may be configured to compare the determined volume with previously determined volumes and identify presence or severity of edema in the body part. The processor may also be configured to identify presence or severity of edema by comparing the identified change in volumes with a predetermined diagnostic edema baseline. The processor may further be configured to determine the efficacy of a therapy or treatment based on the identified change in volumes. 
         [0039]    The plurality of sensors included in the system may include three sensors mounted on a brace positionable such that the three sensors surround a circumference of a lower human leg; and a sensor mounted on the brace positioned such that the sensor is configured to be in contact with a top surface of a human foot. The three sensors may measure the volume of a lower segment of the human leg and the intersecting sensor on a top surface of the human foot may measure the volume at an ankle of the human leg. 
         [0040]    A method for measuring changes in volume of a body part of a user may comprise providing a wearable device comprising a plurality of sensors and a microprocessor for the user to wear on the body part receiving signals generated by the plurality of sensors; and processing the received signals by a processor to determine a circumference at each of the plurality of sensors, calculate a volume of the body part based on the determined circumferences, and compare the determined volume of the body part with at least a previously determined volume to identify a change in volume of the body part. In the method, the wearable device may be configured to be worn on a human leg and foot, in particular the method comprising measuring the volume of a lower segment of the human leg. The plurality of sensors may comprise a plurality stretchable of resistor wires. 
         [0041]    The method may further include measuring a resistance across each sensor, wherein the signal generated by each of the sensors indicates said resistance. The method may further include storing the determined volume and changes in volume over time in a memory coupled to the processor. 
         [0042]    The plurality of sensors used in the method may include three sensors mounted on a brace positioned such that the three sensors surround a circumference of a lower human leg; and a sensor mounted on the brace positioned such that the sensor is configured to be in contact with a top surface of a human foot. The three sensors may measure the volume of a lower segment of the human leg and an intersecting sensor may measure the volume at an ankle of the human leg. The wearable device may be configured to transmit the determined volume to a remote processor to compare the determined volume with previously determined volumes. 
         [0043]    Although certain embodiments have been described and illustrated in exemplary forms with a certain degree of particularity, it is noted that the description and illustrations have been made by way of example only. Numerous changes in the details of construction, combination, and arrangement of parts and operations may be made. Accordingly, such changes are intended to be included within the scope of the disclosure, the protected scope of which is defined by the claims.