This invention relates to systems for determining health conditions.
Every method of measuring physiological functions has inherent limitations. Medical devices and laboratory assays may provide inaccurate results for various reasons including user error, damaged components, or attempts to use the device or assay under conditions for which it was not designed. There are also circumstances under which the medical device or laboratory assay provides data that may not be properly interpreted without knowing specific information about the patient which puts the data in proper context. Furthermore, calculated health indices, for example, Body Mass Index (BMI), are not meaningful for all body types. Additionally, health care providers sometimes simultaneously use multiple clinical measurements, each associated with a different degree of accuracy and relevance to a particular patient, to create a complex assessment of an individual's health or to select a single diagnosis out of a lengthy differential diagnosis. Each measurement may have a different shortcoming that must be taken into account when interpreting the data generated by the measurement. Included in the shortcomings are that the healthcare provider must be aware of inherent instrumental error, interpret the results based on the patient's physical status including body type, medical diagnosis, and current medications, and be aware of the instrumental error associated with a particular measurement event. The latter error may be related to the user's physical status and is particularly difficult for a healthcare provider to estimate when viewing measurement results. This is, at least in part, because the healthcare provider that conducted the measurement may not be the same healthcare provider that analyzes the results. Consequently, the healthcare provider analyzing the results may be unaware of difficulties that occurred during the measurement process. For example, with the growing use of telemedicine, a specialist may consult on a patient he or she has never met. A way to determine the level of accuracy of health-related data, select measurements that are relevant to the particular patient, and to put the data in proper context based on the user's physical status is needed.
We disclose a medical toilet that collects measurements pertaining to a user's health status and which includes a system for identifying the level of validity of the measurements. The system is customized to each user based on physical and demographical information and medical history. The system includes a controller which receives information about a user's physical, demographical, and medical status. The medical toilet may conduct a first measurement which is relevant to the user's health and a second measurement which is an indicator of the validity of the first measurement. The controller may select the type or measurement techniques, the anatomical location from which the measurements are taken, and it may modify the parameters of the instruments taking the measurements all based on the information stored about the user in the controller. The first and second measurements may be analyzed according to at least one set of rules which assign a weight value to the first measurement.
The first and second sets of rules may also vary depending on the user's physical, demographical, and medical status information stored in the controller, including, but not limited to body type, gender, skeletal structure (fine or heavy), medical diagnosis, and current medications. The information may determine which of a plurality of sets of rules are applied to the measurements. New physical status information about the user may be periodically entered into the controller to trigger an alternative set of rules. The system may trigger the collection of a follow-up measurement, which may confirm or contradict the first measurement. Furthermore, the controller may select the follow-up measurement based on the user's physical, demographical, and medical status information.
Some embodiments of the medical toilet may transmit the measurements and calculations to a network database. A healthcare provider may download the data to a user's medical file. Changes to the user's physical status may be transmitted to the medical toilet from a controller located at a remote location so that the medical toilet continues to select the proper measurements, parameters, and rules to apply to collected data.
In addition to interpreting measurements based on a user's physical characteristics, this system adjusts the measurements themselves, including how they are taken with relation to the user's anatomy, the parameters of the instrumentation, as well as assessing the validity of the measurement to provide a customized set of measurements. Initial measurements are adjusted based on input about a user's physical, demographic, and medical status, their validity assessed, then more measurements may be taken with further adjustment. Both the validity of the measurement and the relevance to the user is thereby optimized.
Toilet, as used herein, means a device that collects biological waste products of a mammal, including urine and feces.
Medical toilet, as used herein, means a toilet that conducts one or more measurements relevant to a user's health status. This may include, but is not limited to, quantification of analytes in urine or feces, cardiovascular parameters, bioimpedance measurements, and body weight.
Health status, as used herein, means the current physiological state of a mammal, particularly with regard to disease status or injury. In general, this term refers to the overall health of the mammal. However, individual parameters relating to a specific body part or biological system may be measured for the purpose of diagnosing disease states or identifying physiological characteristics or functions that are outside of the normal range. Such individual physiological characteristics or functions may be used to define the health status of the mammal with regard to a specific physiological system.
User, as used herein, means any mammal, human or animal, for which the medical toilet disclosed herein is used to measure physiological functions which may be used to assess the mammal's health status.
Healthcare provider, as used herein, means any individual who performs a task, mental or physical, in relation to health-related services provided to a user. In addition to clinicians who practice medicine directly on a user, the term healthcare provider includes any person that enters data into a computer, when the data entry is used in analysis of a user's health status or to improve a user's health.
While this invention is susceptible of embodiment in many different forms, there are shown in the drawings, which will herein be described in detail, several specific embodiments with the understanding that the present disclosure is to be considered as an exemplification of the principals of the invention and is not intended to limit the invention to the illustrated embodiments.
Disclosed herein is a method and apparatus for using a medical toilet to conduct customized measurements that provide information about a user's health status. Importantly, the toilet includes a system for customizing the measurements for each user, validating the accuracy of the measurements, and both selecting and performing follow-up measurements that may be needed. The system uses physical, demographical, and medical status information about the user, not just to interpret the measurements, but to make adjustments within the medical toilet and instruments therein to optimally perform the measurements for each user. The physical, demographic, and medical status information may include a body type, including, but not limited to, endurance athlete, weight bearing athlete, non-athlete, male, female, under a defined age, over a defined age, fine skeletal structure, and heavy skeletal structure. The medical status information may also comprise a medical diagnosis and the user's current medications, each of which, may impact reasonable interpretation of the measurements, alter which measurement is most useful for the specific user, and the parameters under which the measurement is taken.
Medical devices are typically designed to be used in the same way for each user. However, in some instances, the optimal parameters to conduct a measurement with a particular medical device vary from user to user. Examples of parameters that may be adjusted based on physical, demographic, and medical status information include, but are not limited to, power level, wavelength of a light source in a spectroscopy instrument, frequency of alternative current electric field, instrument sensitivity, instrument dynamic range, length of measurement time, applied voltage, anatomical location at which the first or second measurement is taken, sample rate, sample volume, and data filter bandwidth. A controller within or connected to the medical toilet may use the physical, demographical, and medical status information to predict the optimal parameters to use with each instrument when collecting measurements for a particular user.
In addition to the parameters used to perform a measurement, often, the type of measurement that is optimal for a user varies according to physical, demographic, or medical status. For example, reliable bioimpedance measurements taken from the thigh may be difficult to obtain from obese users. Therefore, measuring bioimpedance from a different anatomical site on an obese user or conducting a measurement other than bioimpedance may yield more a more useful measurement. In other example, a measurement that requires a user to remain still for a length of time may be suboptimal for young children. In still another example, a user whose disease status or medications cause the user to have a faint pulse. This user may need to have a heart rate measured through the carotid artery, which typically gives a strong signal as compared to the wrist, to acquire a meaningful heart rate measurement.
According to an embodiment of the invention, the validity of a first measurement is assessed by conducting a second measurement. A general explanation of the method to determine the validity of the first measurement is provided in Applicant's U.S. patent application Ser. Nos. 15/270,674 and 15/279,734 which are hereby incorporated by reference in their entirety. A first set of rules may be applied to the first and second measurements which results in a weight value. The weight value is assigned to the first measurement and may be a function of the second measurement. A second set of rules may be applied to the first measurement and the weight value to calculate an indicator value. The indicator value assigns an estimate of validity to the first measurement and, consequently, informs its relevance to a user's health status. The second set of rules may define a threshold value for the weight value and may signal the controller to flag the first measurement as invalid or to be excluded from multi-variable calculations that provide an assessment of the user's health status. A clinician may choose to interpret a first measurement that has a mid-range indicator value in combination with more reliable measurements to bolster the validity of a general trend shown by the first measurement. Thus, the first measurement may provide some value but is not assigned more relevance than it merits. The rule sets may vary for each user as a function of the physical, demographical, and medical information stored in the controller for that user. This is at least because a measurement that may seem suspect for one user may be expected for another user depending on physical, demographical, or medical differences between the two users. Thus, the estimate of validity may be dependent on the physical, demographical, and medical information provided for the user.
Referring now to the figures,
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Medical toilet 205 may conduct a plurality of measurements including, but not limited to, body temperature, body weight, body composition (i.e. percent body fat, intracellular and/or extracellular water), heart rate, pedal pulse rate, blood pressure, blood oxygen saturation, electrocardiogram measurement, urine constituents and parameters including urine color, glucose, urea, creatinine, specific gravity, urine protein, electrolytes, urine pH, osmolality, human chorionic gonadotropin (for detecting pregnancy), hemoglobin, white blood cells, red blood cells, ketone bodies, bilirubin, urobilinogen, free catecholamines, free cortisol, phenylalanine, and urine volume. The measurements may also include fecal analysis including fecal weight and volume, calprotectin, lactoferrin, hemoglobin, stress test, blood pressure, hematocrit, serum insulin level, hemoglobin A1c, breathing rate, blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, serum bilirubin, serum total protein, serum albumin, serum gamma-glutamyl transpeptidase, prothrombin time, Holter monitoring, serum levels of a pharmaceutical product, and serum levels of a metabolite of a pharmaceutical product. Additionally, sensors that measure flow, volume, or weight may determine periods of excretion activity to measure, for instance, urination or defecation exertions, or selectively record measurements that were collected during periods of low exertion. These measurements are useful because certain other measurements are best performed after complete voiding of the bowel and bladder for maximum accuracy.
While specific embodiments have been illustrated and described above, it is to be understood that the disclosure provided is not limited to the precise configuration, steps, and components disclosed. Various modifications, changes, and variations apparent to those of skill in the art may be made in the arrangement, operation, and details of the methods and systems disclosed, with the aid of the present disclosure.
Without further elaboration, it is believed that one skilled in the art can use the preceding description to utilize the present disclosure to its fullest extent. The examples and embodiments disclosed herein are to be construed as merely illustrative and exemplary and not a limitation of the scope of the present disclosure in any way. It will be apparent to those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the disclosure herein.
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Number | Date | Country | |
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20180140284 A1 | May 2018 | US |