“System And Method To Detect Changes In Health Parameters And Activate Lifesaving Measures” in Patent Application Approval Process (USPTO 20220401035): Sherlock Solutions LLC
2023 JAN 10 (NewsRx) -- By a
This patent application is assigned to
The following quote was obtained by the news editors from the background information supplied by the inventors: “
“Certain exemplary embodiments provide apparatuses, methods, processes, and/or systems related to detecting significant detrimental changes in health parameters, and facilitating help for the user. Systems, methods, processes and apparatuses, will most likely benefit people through the use of preferred embodiments that have widespread popular appeal, and thus can make the most substantial public health impact.
“Certain exemplary embodiments address a question, “how can a patient, or a bystander, know when to activate the emergency response?” Those skilled in the art will recognize that it is common practice to use a resource rich device, such as a 12-lead, a 5-lead electrocardiogram (ECG, or also known as an EKG), or another device unrelated to the heart, which uses a significant amount of information to make a diagnosis. In the hands of a healthcare professional such as a doctor, or an EMT, a specific diagnosis can be made that pinpoints the problem. It can be extremely difficult to make a specific medical diagnosis without such analytical devices. However, a specific diagnosis is not necessary to acknowledge tempestuous changes in health that should cause alarm.
“For the first time in history, multi-sensor capable devices (smart devices) are being popularized on millions of wrists (and other body parts) making implementation of lifesaving technology “fashionable,” even if detecting a heart attack, or another health problem, is far from the primary reason someone may wear the device.
“Embodiments that utilize watch form factor or another wearable biometric device, suffer from the reality that it takes a tremendous amount of computational ability and energy to make use of most sensors. Also, it is a problem that current inventions in the field do not fully conceptualize a system to deal with the difficulty of acquiring a resource poor signal that is so noisy; where the noise is often higher than the signal.
“In addition, wearing such a device that integrates with a system may justify a change (increase/decrease) in insurance premiums, such as with life insurance, health insurance, or other insurances, based on the availability of more health parameters. In another example, insurance premiums may also justifiably be lowered as this apparatus and system lowers the probability of a catastrophic event from happening, and thereby will lower the cost to insurers.”
In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventor’s summary information for this patent application: “Certain exemplary embodiments address certain disadvantages mentioned above and consider additional aspects that have utility for the aforementioned application in the form of apparatuses, methods, processes, and systems.
“Certain exemplary embodiments can utilize any wearable biometric device that a person could wear in a non-invasive fashion, preferably but not limited to the form of a commonly worn object. A biometric device can generally be considered any apparatus that gathers measurable inputs pertaining to an organism. Some examples of commonly worn objects are watches, eyeglasses, earphones, headphones, armbands, wristbands, ankle bands, jewelry (such as earrings, bracelets, necklaces, or rings), and/or other commercialized items. Ideally some people might not consider the apparatus to have any burden on their lives. The intent of such a device is to so seamlessly fit into the fabric of everyday lives, that this device could possibly be an add-on to another device and need not necessarily be a device independently designed for detecting health related parameters.
“Certain exemplary embodiments can be adapted to detect and alert individuals of significant detrimental changes to any health related parameters while minimally impacting a user’s daily life. A preferred embodiment of the apparatus detects significant detrimental changes in cardiac and/or neurologic activity, as well as but not limited to changes in heartbeat, blood pressure, heart rate, cardiac electrical signature, neurologic electrical signature, pulse transit time or any other signal generated directly or indirectly by the user’s heart or brain, and/or other biometric outputs; in order to give a patient and/or surrounding people advanced warning of a health related issue; and/or to activate the emergency medical system (EMS); and thereby efficiently transfer himself or herself to the appropriate healthcare professional. Alternatively, the apparatus can also warn a healthcare professional directly, such as but not limited to a physician, a government service, or non-government service, that can notify the user of the significant detrimental changes in their cardiac and/or neurological activity, and encourage the user to seek medical attention. Such an apparatus can also seek the help of a healthcare professional if the patient is unable to do so.
“An exemplary biometric apparatus can use any means of detection such as, but not limited to, electric, magnetic, optical, acoustic, pneumatic, thermal, nuclear, mechanical, hydraulic, and/or vacuum, etc. Certain exemplary embodiments can detect a myocardial infarction (Ml), also known as a heart attack, but could also relate to other presentations, conditions, and diseases such as sudden cardiac death (SCD), stroke, seizure, hypertension, hypotension, arrhythmia, vascular aneurysm, congestive heart failure, valvular heart disease, cardiac muscle disease, tumors, Alzheimer’s disease, dementia, psychosis, sleep disorders, attention-deficit/hyperactivity disorder (ADHD), coma, head injuries, infections, and/or death, and many others not explicitly specified. Certain exemplary embodiments are not limited to emergency situations, but can also be used in non-emergent situations, such as routine check-ups and yearly physicals, as well as in other situations. Those skilled in the art will understand that changes in cardiac and/or neurologic activity can be indicative of other medical problems not directly stemming from the heart or brain, and can be used as a valuable diagnostic indicator for many reasons.
“Electrocardiography (ECG) and electroencephalography (EEG) are considered by some to be the gold standard techniques to monitor a heart and brain respectively, but there are also other useful technologies that make use of pulse oximetry, laser Doppler flowmetry (LDF), ultrasound, piezoelectricity, capacitance, temperature, radioactivity, and/or other non-invasive diagnostic technologies. ECG and EEG sensors have substantial utility in a wearable biometric device for the purpose of assessing changes in a heart or brain due to the quantifiable nature of electric properties. However, the pairing of an ECG sensor, or an alternate sensor, with another non-invasive sensor can be useful, but is not required, for a variety of reasons. One reason is to rule out conditions such as pulse-less electrical activity (PEA), where it is possible to have an unremarkable ECG, but to have a heart that does not mechanically function-obviously a life threatening issue to a patient. Another reason is that it is possible to greatly enhance the accuracy of the preferred embodiment by synergistically incorporating data from two or more sensors. To detect a user’s changes in heartbeat, blood pressure, heart rate, cardiac electrical signature, neuronal electrical signature, pulse transit time, or any other signal generated directly or indirectly by the user’s heart or brain, or other biometric outputs, the biometric apparatus can include one or more embedded sensors; for example, an ECG sensor and/or a laser Doppler flowmeter.
“The ECG and/or EEG sensor(s) of an exemplary apparatus can comprise at least two electrodes, as both modalities operate on the principle of voltage difference. To maximize voltage difference for an ECG on the wrist, one electrode could be placed within the case back of the watch, and another could be placed on the band on the substantially opposite side. To maximize voltage difference for an EEG contained within eyeglasses, one electrode could be placed on each side of a user’s head by the ear. Those skilled in the art will recognize that there are a variety of placements that the electrodes can be located to achieve similar results, especially when considering the ideal proximity of a complementary sensor that can be similarly placed within the case back of the watch or band, the frame of eyeglasses, or other locations. It should be noted that relatively close placement of electrodes, such as points around one wrist, can result in noise and difficulty in obtaining a signal.
“Therefore, it is advantageous, but not required, to incorporate multiple types of sensors in order to assist a lifesaving algorithm by creating more data points, thus mitigating ECG data noise from the wrist or another distant point from the heart. By taking an ECG in this manner, many times it has been found that the noise is more pronounced than the true signal, thus creating a significant obstacle. The same concepts can be applied to a noisy EEG with only two electrodes providing data. In one embodiment where an ECG and a laser Doppler flowmeter are used, the laser Doppler flowmeter can detect the beats of the heart, and create tight ranges for signal processing to search for the heart’s normally periodic electrical signals within the repository of collected ECG signals from the user. For example, it is much easier to look for a P wave, QRS complex, or T wave, when it exists within certain finite ranges. Moreover, it is far easier to find one of the most pronounced signals-the QRS complex-if a determination can be made of the limits of the ECG signal (the voltage difference and time), and determine where the periodicity of the ECG data lies so signal processing knows how and where to search. Having a repository of collected signals from the user can be useful in cleaning up signals, as it can provide more data and improve the algorithmic capability for detecting significant detrimental cardiac and/or neurological changes in a person.
“It can also be advantageous, but not required, to create a redundant number of sensors because biometric devices disguised as commercialized accessories, such as watches, are worn in a variety of ways. An example of an immediate issue is the fact that people wear their watches on different wrists depending on their preference, or their handedness. In some cases, it may be necessary to reverse the directionality of the data from the sensor to capture the correct signal, or to use different sensors to capture the correct data if one is not adequately contacting the individual. In the embodiment of a watch, it may be important for the watch’s interface to ask the user what wrist they are wearing the device on, or for the watch to make this determination automatically. Even preferences such as the tightness of the watch can affect performance, but that issue can be mitigated by having sensors at a variety of high probability contact points, such as the case back of the watch, the left and right interior edges of the watch band, the clasp, the part of the band directly opposite the watch’s case back, and other components of the watch. Those skilled in the art can envision how the idea of redundancy broadly applies exemplary embodiments.
“A key issue can be the clarity of the ECG signal that can be achieved when electrodes are placed in such close proximity to each other, especially when they are distant from the heart. In such embodiments, the use of highly conductive sensors, high fidelity analogue to digital (A/D) converters, signal processing, algorithmic analysis, and primary processors and power supplies make the detection of a noisy ECG possible. Other embodiments can further clarify the signal or provide other useful information, which can include wearable devices in two or more places on the body in wireless or wired communication with each other; for example, a watch with eyeglasses, or a watch with a wristband on the other arm.”
There is additional summary information. Please visit full patent to read further.”
The claims supplied by the inventors are:
“1. A method comprising: detecting a biometric data of a user during a calibration period, the biometric data detected via a device having at least one sensor secured to the user; calibrating the device based on the biometric data to yield a calibration profile of the user; detecting new biometric data of the user via the sensor; comparing the new biometric data with the calibration profile to determine whether the user has experienced a change; and generating an alert when the user has experienced at least a detrimental change.
“2. The method of claim 1, wherein the calibrating of the device based on the biometric data includes comparing the biometric data to a population norm for the biometric data detected.
“3. The method of claim 1, wherein the calibrating of the device based on the biometric data includes determining an average of the biometric data.
“4. The method of claim 1, wherein the calibrating of the device includes comparing the biometric data of the user to a past medical history of the user, the past medical history input into the device via a user interface.
“5. The method of claim 1, further comprising: instructing the user not to move for a baseline portion of the calibration period; instructing the user to perform a physical activity for an active portion of the calibration period; determining whether the user is performing the physical activity; and wherein the calibrating of the device is based on the biometric data detected during the active portion of the calibration period when it is determined that the user is performing the physical activity.
“6. The method of claim 5, wherein the determining of whether the user is performing the physical activity is determined via a motion sensor.
“7. The method of claim 5, wherein the determining of whether the user is performing the physical activity is determined via user input into the device via a user interface.
“8. The method of claim 1, wherein the alert includes at least one of an audible alarm, a visual queue, a vibration, a text message, or a phone call.
“9. The method of claim 1, wherein the generating of the alert includes initiating a communication between the device and a third party.
“10. The method of claim 9, wherein the communication to the third party includes two-way audio communication with the third party.
“11. The method of claim 9, further comprising: canceling the alert by making a selection on a display of the device to cancel the communication to the third party.
“12. The method of claim 9, wherein the communication to the third party includes a one-way transmission to initiate emergency medical services.
“13. The method of claim 1, wherein the device is (i) an electrocardiogram sensor, and (ii) operable to couple to the user in at least two locations.
“14. The method of claim 1, wherein the device is configured to monitor a heart rate of the user.
“15. The method of claim 1, wherein the device is configured to monitor blood pressure of the user.
“16. The method of claim 1, wherein determining whether a change is detrimental includes (i) determining a confidence level associated with the new biometric data, and (ii) determining a deviation of the new biometric data from the calibration profile based upon the confidence level.
“16. The method of claim 1, wherein the device is configured to (i) detect data from a plurality of sensors to account for disturbances or to boost data certainty, (ii) render the new biometric data from the sensor over a determined time period, and (ii) render a deviation of the new biometric data from a baseline value.
“17. The method of claim 1, further comprising: processing the new biometric data, via a processor, to generate one or more processed signals; determining a confidence level based on the processed signals; and determining whether the user has experienced the detrimental change based on the confidence level.
“18. The method of claim 1, wherein, the at least one sensor includes a plurality of sensors; and the device is configured to use data received from the sensors to account for disturbances and to boost data certainty.”
URL and more information on this patent application, see: Sampson, Robert. System And Method To Detect Changes In Health Parameters And Activate Lifesaving Measures.
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