Abstract:
A non-transitory computer-readable storage medium storing a set of instructions executable by a processor. The set of instructions is operable to receive a set of data relating to a current symptom of a patient; determine one of a current level of breathlessness and a current level of edema for the patient based on the received data; and provide an alert to one of the patient and a medical professional, if the determined one of the current level of breathlessness and the current level of edema is greater than an acceptable level.

Description:
CROSS-REFERENCE TO PRIOR APPLICATIONS 
       [0001]    This application is a U.S. Divisional application of the U.S. patent application Ser. No. 14/005,352, filed on Sep. 16, 2013, under 35 U.S.C. §371 of International Application No. PCT/IB2012/051121, filed on Mar. 9, 2012, which claims the benefit of U.S. Provisional Patent Application No. 61/453,153, filed on Mar. 16, 2011. These applications are hereby incorporated by reference herein. 
     
    
     BACKGROUND 
       [0002]    Patients suffering from chronic conditions may perform in-home monitoring of their symptoms in order to evaluate whether their condition is improving or deteriorating. Self-monitoring may enable patents&#39; condition to be monitored at a cost significantly less than that of in-home care or inpatient treatment. However, self-monitoring also suffers from deficiencies due to subjective assessment and lack of detailed objective information provided by the patient. 
       SUMMARY OF THE INVENTION 
       [0003]    A non-transitory computer-readable storage medium stores a set of instructions executable by a processor. The set of instructions is operable to receive a set of data relating to a current symptom of a patient. The set of instructions is further operable to determine one of a current level of breathlessness and a current level of edema for the patient based on the received data. The set of instructions is further operable to provide an alert to one of the patient and a medical professional, if the determined one of the current level of breathlessness and the current level of edema is greater than an acceptable level. 
         [0004]    A system includes a voice recording apparatus, a speech recognition unit, and a processor. The voice recording apparatus records an audio recording of a patient during a time interval. The speech recognition unit receives the audio recording and determines, from the audio recording, a number of pauses during the time interval and a length of each of the pauses. The processor determines, based on the number of pauses and the length of each of the pauses, a breathlessness score for the patient corresponding to the time interval. 
         [0005]    A system includes a pressure management apparatus and a processor. The pressure management apparatus includes a plurality of pressure-sensing regions. Each of the pressure-sensing regions corresponds to a body portion of the patient. The pressure measurement apparatus is adapted such that a tactile compression response of each of the pressure-sensing regions is substantially similar to a tactile compression response of the corresponding body portion. The processor receives pressure measurements from the pressure measurement apparatus. Each of the pressure measurements corresponds to a congestion in a body region of a patient. The processor determines a level of edema based on the pressure measurements and generates an alert if the level of edema is greater than a predetermined value. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0006]      FIG. 1  shows an exemplary embodiment of a system for the objective assessment of patient symptoms. 
           [0007]      FIG. 2  shows an exemplary embodiment of an ankle measurement device. 
           [0008]      FIG. 3  shows an exemplary embodiment of a method for the objective assessment of patient symptoms. 
           [0009]      FIG. 4  shows an exemplary method for a first implementation of the exemplary method of claim  3 . 
           [0010]      FIG. 5  shows an exemplary method for a second implementation of the exemplary method of claim  3 . 
       
    
    
     DETAILED DESCRIPTION 
       [0011]    The exemplary embodiments of the present invention may be further understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals. The exemplary embodiments describe systems and methods by which patient symptoms may be monitored and evaluated objectively in order to determine whether a patient&#39;s condition has improved or deteriorated. 
         [0012]    The periodic assessment of the symptoms affecting patients is crucial for the monitoring of patients suffering from chronic conditions. This is especially important for patients suffering from heart failure, but also true for patients suffering from other chronic conditions, such as chronic obstructive pulmonary disease (“COPD”), kidney failure, etc. Such monitoring is required to determine whether a patient&#39;s treatment needs to be modified (e.g., whether medication is required, whether dosing of existing medication should be changed, whether hospitalization is required, whether closer monitoring by medical professionals is required, etc.). 
         [0013]    However, existing methods for making such decisions are typically based on information provided by patients in response to self-administered questionnaires, which prompt a patient to answer a series of questions, rate his own symptoms, etc. One type of questionnaire may ask a patient to report loss of breath during various activities (e.g., sitting, standing, walking, etc.). Another type of questionnaire may ask a patient to report on swelling of various parts of the body (e.g., ankles, legs etc.) at various times of the day (e.g., morning, midday, evening, etc.). Another type of questionnaire may ask a patient to report on general well-being (e.g., happy, neutral, unhappy). Another type of questionnaire may ask a patient to report on weight gain or weight loss. In each of these cases, patients are asked questions relating to the above conditions on a regular basis, either face-to-face or by a telemonitoring system, and the patient reports on his own conditions. 
         [0014]    In one example, the accumulation of fluids in bodily tissues, known as edema, may be a sign of worsening heart failure, kidney damage, or COPD. Edema may be observed by observing swelling in a patient&#39;s body, typically in the ankles and legs but also in the abdomen or the hands. Thus, by observing such swelling, treatment may be administered before hospitalization is required. Patients may self-assess edema symptoms by monitoring their weight and/or swollen body parts daily. 
         [0015]    This method of gathering information may suffer from various deficiencies. First, surveys that require patients to answer a variety of questions at periodic intervals may be difficult, cumbersome, or tedious to complete. In such cases, a patient may fail to answer questions or provide inaccurate information. Second, the information requested is subjective, and the reliability of the resulting data may therefore be suspect. For example, a patient who is self-assessing edema may not be capable of distinguishing between different levels of congestion. Third, the surveys do not necessarily result in information that is detailed enough to deduct the cause of a particular symptom, resulting in the need for medical personnel to spend time ascertaining further information (e.g., type of activity during which reported shortness of breath occurred, potential causes for reported weight gain, etc.). 
         [0016]    The exemplary embodiments aid in the assessment of patient symptoms by providing simplified and objective assessment of symptoms that may be assessed subjectively by prior methods. An exemplary system  100 , illustrated in  FIG. 1 , objectively measures the symptoms of a patient  10 , as will be described below, in order to make determinations about the patient&#39;s condition. Feedback about these determinations may be provided to the patient  110 , to medical professionals  115  (e.g., doctors, nurses, etc.), or both. 
         [0017]    Patient symptoms are measured by one or more mechanisms, including a position detection element  120 , a mode detection element  121 , an elevation detection element  122 , a video recording apparatus  123 , a voice recording apparatus  124 , an ankle measurement device  125 , and a weight measurement device  126 . The operation of each of these mechanisms will be described in further detail below. 
         [0018]    The position detection element  120  detects a position of the patient  110  (e.g., laying, sitting, standing, etc.). The position may affect the significance of any breathlessness being experienced by the patient  110 . For example, loss of breath experienced by a patient who is laying down may be a more significant indication of a worsening condition than loss of breath experienced by a patient who is standing. For a patient who is being monitored at home, the position detection element  120  may be a gyroscope (e.g., part of an activity monitoring device) configured to determine the patient&#39;s position using methods that are known in the art. For a patient who is being monitored in the hospital, the position detection element  120  may be a sensor mounted on the patient&#39;s hospital bed. 
         [0019]    The mode detection element  121  detects an activity mode of the patient  110  (e.g., stationary, walking, running, etc.). As was the case for the patient&#39;s position, the mode may affect the significance of any breathlessness being experienced by the patient  110 . For example, loss of breath experienced by a patient who is stationary may be a more significant indication of a worsening condition than loss of breath experienced by a patient who is moving. The mode detection element  121  may be an accelerometer (e.g., part of an activity monitoring device) configured to determine the patient&#39;s mode using methods that are known in the art. This may be, for example, as part of a laptop computer or mobile phone used by the patient. For a patient who is hospitalized, the mode detection element  121  may be a bed-mounted sensor that detects if the bed is occupied (e.g., the patient is stationary) or empty (e.g., the patient is moving), or, alternately, may be a piece of exercise equipment (e.g., a treadmill) used in physical therapy that detects the same information. 
         [0020]    The elevation detection element  122  detects changes in the elevation of the patient  110  (e.g., if the patient  110  is climbing stairs, etc.). As above, this may affect the significance of any loss of breath experienced by the patient  110 . For example, loss of breath while climbing stairs may be less significant than loss of breath experienced while the elevation of the patient is constant. The elevation detection element  122  may be a barometer configured to detect changes in the patient&#39;s mode using methods that are known in the art. As above, this may be an element of a laptop computer or mobile telephone used by the patient. 
         [0021]    The video recording apparatus  123  records video data of the facial expression of the patient  110  in order to ascertain the well-being (e.g., mood) of the patient, as will be described in further detail below. In one embodiment, the video recording apparatus  123  is a video camera or a group of video cameras, which are disposed in the home of the patient  110 , a hospital room housing the patient  110 , etc. 
         [0022]    The voice recording apparatus  124  records speech of the patient  110  in order to determine whether the patient  110  is out of breath, as will be described in further detail below. In one embodiment, the voice recording apparatus  124  is a microphone, which may be mounted on a hospital bed, on the patient&#39;s clothing, etc. In another embodiment, the voice recording apparatus  124  is a built-in microphone or home camera that is part of a mobile telephone used by the patient, an in-home patient monitoring system including microphones and/or video cameras, etc. 
         [0023]      FIG. 2  illustrates an exemplary ankle measurement device  125 . The ankle measurement device  125  includes a plurality of regions  210 ,  211  and  212  that correspond to regions of a leg of the patient  110 ; those of skill in the art will understand that the presence of three regions is only exemplary and that other numbers of regions may be possible in other embodiments. In this exemplary embodiment, the first region  210  corresponds to the patient&#39;s ankle, the second region  211  corresponds to a portion of the patient&#39;s leg below the knee, and the third region  212  corresponds to a portion of the patient&#39;s leg above the knee. The ankle measurement device  125  is constructed in a manner that the patient  110  may press on the various regions  210 ,  211  and  212  in a manner to simulate pressing on swelling in the corresponding portion of the leg. In one embodiment, an exterior portion  220  of the ankle measurement device  125  is comprised of rubber or a similar elastic material, and the exterior portion  220  encloses a plurality of pressure sensors  230 ,  231  and  232  (e.g., one pressure sensor corresponding to each of the regions  210 ,  211  and  212 ) that respond in a manner that will be described below when the patient  110  presses on the corresponding region. Those of skill in the art will understand that the pressure sensors  230 ,  231  and  232  are internal to the ankle measurement device  125 , and are thus not shown in  FIG. 2 . The ankle measurement device  125  also includes an indicator  240  (e.g., an LED or other light source) that may light up in varying manners to provide feedback to the patient  110 , as will be described in further detail below. Those of skill in the art will understand that while the exemplary system  100  includes an ankle measurement device  125 , other exemplary systems may include devices adapted to measure pressure in other parts of the body where swelling may indicate edema, such as the abdomen or the hands. 
         [0024]    The weight measurement device  126  periodically measures the weight of the patient  110  in order to determine whether weight gain is at a level that may be indicative of a worsening condition, as will be described in further below. The weight measurement device  126  is typically a scale that the patient  100  is instructed to use to weigh himself or herself periodically (e.g., daily, every other day, etc.); in another embodiment, the weight measurement device  126  is embedded into a hospital bed of a patient who is hospitalized. 
         [0025]    The system  1  also includes further elements for analyzing the data collected by the elements described above. This may include a mode recognition unit  130 , a facial expression recognition unit  131 , and a speech recognition unit  132 . The mode recognition unit  130  communicates with the position detection element  120 , the mode detection element  121 , and the elevation detection element  122 , as illustrated in  FIG. 1 , and may be, for example, a combination of hardware and software. The mode recognition unit  130  receives data from the above-mentioned elements, and uses the received data to determine a mode of activity for the patient  110 . The mode may be, for example, laying, walking, running, climbing stairs, etc. 
         [0026]    The facial expression recognition unit  131  may also be a combination of hardware and software, and receives data from the video recording apparatus  123 . The facial expression recognition unit  131  monitors the facial expression of the patient  110 , and outputs a classification. The classification may be, for example, happy, neutral, unhappy, etc. 
         [0027]    The speech recognition unit  132  may also be a combination of hardware and software, and receives data from the voice recording apparatus  124 . The speech recognition unit  132  performs sequencing of the recorded speech of the patient  110 , and outputs data identifying pauses in speech, length of the pauses, and frequency of the pauses. 
         [0028]    The edema evaluation unit  133  may also be a combination of hardware and software, and receives data from the ankle measurement device  125  and the weight measurement device  126 . The edema evaluation unit  133  monitors changes in ankle swelling, as measured by the ankle measurement unit  125 , and the weight of the patient  110 , as measured by the weight measurement unit  126 , to determine whether the patient  110  is experiencing edema. As described above, edema may be a sign of worsening heart failure, kidney damage, or COPD. 
         [0029]    The system  1  also includes a processing unit  140  receiving data from the mode recognition unit  130 , the facial expression recognition unit  131 , and the speech recognition unit  132 . The data so received is used to make determinations regarding the patient&#39;s overall status, as will be described in further detail below. In some embodiments, the processing unit  140  compares the patient&#39;s current condition to relevant data that is stored in data storage  150 , and the current information about the patient  110  is further stored in the data storage  150  for subsequent use or retrieval. In situations where the patient&#39;s symptoms indicate a worsening condition, feedback is provided either to medical professionals  160  (e.g., a doctor, a nurse, etc.), directly to the patient  110 , or both as appropriate. 
         [0030]      FIG. 3  illustrates a generalized exemplary method  300  for collecting and using patient data, which may be implemented using system elements such as those described above with reference to  FIG. 1 . In step  310 , objective data regarding symptoms experienced by a patient (e.g., patient  110 ) is collected. This includes any of the types of data described with reference to the elements of the system  100  of  FIG. 1 , such as data relating to patient position, patient activity, patient elevation, patient facial expression, patient speech, patient weight, patient swelling, etc. In step  320 , the data collected in step  310  is analyzed. The analysis step may entail various specific tasks, depending on the nature of patient data that has been collected.  FIGS. 4 and 5 , to be discussed below, will illustrate exemplary methods  400  and  500 , respectively, detailing specific methods of analyzing specific types of patient data. In step  330 , data is archived, such as in data storage  150  of system  100 . Data to be archived may include raw data collected in step  310 , analyzed data produced in step  320 , or both. Last, in step  340 , feedback is provided to the patient, to medical professionals, or both. 
         [0031]      FIG. 4  illustrates a method  400  that is a version of the method  300  that is specific to data collected by the ankle measurement device  125  and the weight measurement device  126  of  FIG. 1 . In step  410 , the patient (e.g., patient  110 ) squeezes his or her leg at various points, each point corresponding to a measurement point on the ankle measurement device  125 , to gauge for swelling at various points. As described above, this includes a point at the ankle, a point below the knee, and a point above the knee, although this may vary among differing implementations. 
         [0032]    In step  420 , the patient squeezes the points on the ankle measurement device  125  corresponding to the points on the leg discussed above (e.g., first region  210  corresponding to a point at the ankle, second region  211  corresponding to a point below the knee, and third region  212  corresponding to a point above the knee, etc.). The ankle measurement device  125  detects and records the pressure exerted by the patient in this step, which corresponds directly to congestion at the point in the leg corresponding to the measurement point in the ankle measurement device  125 . Those of skill in the art will understand that the above steps may vary, and that in some embodiments the patient  110  may be instructed to measure at certain points at specified times of the day, at all points each time the device is used, etc., depending on the preferences of the patient&#39;s doctor. 
         [0033]    In some embodiments, in step  430  the patient&#39;s weight is recorded using weight measurement device  126 . Thus, it will be apparent to those of skill in the art that steps  410 ,  420  and  430  are analogous to the data collection step  310  of method  300 . 
         [0034]    In step  440 , the measured data is evaluated, such as by edema evaluation unit  133  of system  100 . In one exemplary embodiment, a currently-measured congestion level (e.g., a measurement at a single point on the device, a composite of measurements at several points on the device, etc.) is compared to a baseline congestion level (e.g., the congestion level when the patient  100  was most recently discharged from inpatient care, etc.). A threshold value (e.g., as defined by a doctor) may also be used in this comparison. 
         [0035]    In step  450 , the currently-measured congestion level or levels are stored, e.g., in data storage  150  of system  100 . In step  460 , feedback is generated as appropriate. For example, if the current congestion level is acceptable, the indicator  240  on the ankle measurement device  126  is illuminated green to indicate to the patient  100  that the congestion level is acceptable, and no feedback is provided to medical professionals  115 . An acceptable level may be defined as a value that is less than the sum of the baseline value and the threshold value. Conversely, if the current congestion level is unacceptable (e.g., indicative of worsening condition), then the indicator  240  on the ankle measurement device  126  is illuminated red to indicate to the patient  100  that the condition may be worsening, and corresponding feedback is provided to medical professionals  115 . 
         [0036]    In embodiments where weight is measured in step  430 , this is also included in the evaluation as described above. In one embodiment, the patient&#39;s doctor may determine an acceptable weight range for the patient (e.g., plus or minus two kilograms), and if the patient&#39;s weight gain or loss has exceeded the thresholds set by the doctor, that information is considered along with congestion in determining whether the patient  110  is suffering from edema. For example, a weight gain of greater than two kilograms in two days itself trigger an alert as described above. Alternately, the information about the weight gain may be aggregated with the measured congestion, and the aggregated amount is compared to a single threshold value in determining whether to trigger an alert. 
         [0037]      FIG. 5  illustrates a method  500  that is a version of the method  300  that is specific to data collected by the position detection element  120 , the mode detection element  121 , the elevation detection element  122 , the video recording apparatus  123 , and the voice recording apparatus  124  of  FIG. 1 . In step  510 , data regarding the patient is collected. This involves collecting data at discrete intervals, aggregating data over a period of time, or continuous collection; those of skill in the art will understand that the method described herein may apply to each of the above methods of collection, and to evaluation on corresponding time scales, without departure from the broader principles described. As will be apparent to those of skill in the art, this includes data recorded by the position detection element  120 , the mode detection element  121 , the elevation detection element  122 , the video recording apparatus  123 , and the voice recording apparatus  124  of  FIG. 1 . 
         [0038]    In step  520 , an activity mode of the patient  110  is determined by the mode recognition unit  130 . This may be accomplished using known methods and based on data received from the position detection element  120 , the mode detection element  121 , and the elevation detection element  122 . As described above, the activity mode may be, for example, walking, running, laying, sitting, climbing stairs, standing, etc. Further, the activity mode may be determined continuously, periodically, at discrete intervals, etc., as described above. 
         [0039]    In step  530 , a facial expression category of the patient  110  is determined by the facial expression recognition unit  131 . This may be accomplished using known methods, and may be based on data received from the video recording apparatus  123 . In one embodiment, the facial expression may be categorized as “happy”, “neutral”, or “unhappy”. The facial expression is calculated at intervals corresponding to those for which the patient mode is detected in step  520 . 
         [0040]    In step  540 , the speech recognition unit  132  performs speech sequencing on the data provided by the voice recording apparatus  124 . This may be accomplished using known methods, and may result in identification of pauses in the speech of the patient  110 , the length of the pauses, and their frequency within a given time period. The time period concerned may be a time period corresponding to a time period during which the patient&#39;s mode was calculated during step  520 , and during which the patient&#39;s facial expression was classified during step  530 . 
         [0041]    In step  550 , the processing unit  140  calculates a breathlessness score for the patient  100 , based on the results of steps  520 ,  530  and  540 . Each activity mode M may have a corresponding priority rate PW(M), indicating the significance of breathlessness during a particular mode. Activity modes during which the patient is less active may have higher priority rates, indicating that breathlessness during such activity modes is a more serious indication of worsening condition. For example, a mode “laying” has a priority weight  5 , a mode “sitting” has a priority weight  4 , a mode “walking” has a priority weight  3 , a mode “running” has a priority weight  2 , and a mode “climbing stairs” has a priority weight  1 ; those of skill in the art will understand that these priority weights are only exemplary and that the weighting may vary among differing embodiments. 
         [0042]    Breathlessness score may be calculated periodically, e.g., once per hour, twice per day, once per day; this may vary among differing embodiments, may be user-configurable (such as by the patient&#39;s doctor), etc. During the given interval, the breathlessness score is determined as the sum, over all modes occurring during the time period, of the priority weight of the mode, multiplied by the number of pauses multiplied by the total duration of the pauses during the mode, divided by the duration of the mode. This is expressed as: 
         [0000]    
       
         
           
             
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                 PW 
                  
                 
                   ( 
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               × 
               
                 
                   # 
                    
                   
                       
                   
                    
                   Pauses 
                   × 
                   PausesDuration 
                 
                 ModeDuration 
               
             
           
         
       
     
         [0043]    In other embodiments, the patient facial expression data may also be evaluated as part of the breathlessness score. For example, if breathlessness has been detected and the facial expression also indicates that the patient is unwell, the severity of the breahlessness indication may be increased as a result. 
         [0044]    Those of skill in the art will understand that steps  520 ,  530 ,  540  and  550  correspond to the analysis step  320  of the method  300  of  FIG. 3 . In step  560 , data is stored in the data storage  150 . Data to be scored includes raw data, analyzed data (e.g., the breathlessness score) or both. Finally, in step  570 , feedback is generated if appropriate. As described above, feedback is provided directly to the patient  110 , to medical professionals  115 , or both. Feedback may be appropriate, for example, where the current breathlessness score is worse than the score for the previous time interval (e.g., the previous day&#39;s breathlessness score), where the breathlessness score is worse than a level specified by a doctor, or based on other criteria that may be appropriate. 
         [0045]    The exemplary embodiments thus use objectively recorded data to replace subjective observations or opinions in methods for determining whether the condition of a patient suffering from a chronic illness has worsened. This may provide results that are more reliable, are obtained regularly without subjecting a patient to questionnaires that may yield untrustworthy or missing data, and more accurately predicts the worsening of a patient&#39;s condition so that treatment can be sought and administered before an emergency exists. 
         [0046]    Those skilled in the art will understand that the above-described exemplary embodiments may be implemented in any number of manners, including, as a separate software module, as a combination of hardware and software, etc. For example, the mode recognition unit  130  may be a program containing lines of code that, when compiled, may be executed on a processor. 
         [0047]    It is noted that the claims may include reference signs/numerals in accordance with PCT Rule 6.2(b). However, the present claims should not be considered to be limited to the exemplary embodiments corresponding to the reference signs/numerals. 
         [0048]    It will be apparent to those skilled in the art that various modifications may be made in the present invention, without departing from the spirit or the scope of the invention. Thus, it is intended that the present invention cover modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.