12-lead electrocardiogram using a 3-electrode device

Abstract

The apparatus includes an electrocardiogram device having a first electrode assembly, a second electrode assembly, and a third electrode assembly with a first electrode, a second electrode, and a third electrode adapted to measure a first electrical signal, a second electrical signal, and a third electrical signal, respectively, of an individual. The apparatus further includes a processing device for determining Lead I from the first electrical signal and the second electrical signal, determining Lead II from the second electrical signal and the third electrical signal, generating Lead III using (Lead III = Lead II - Lead I), generating Lead III trained using the measured 12-lead ECG data, determining Leads aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 based on Lead I, Lead II, and Lead III using a machine learning model trained using the measured 12-lead ECG data, and providing the following leads for display on the client device: Lead I, Lead II, Lead III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 62 / 946,331, filed December 10, 2019, and U.S. Nonprovisional Application No. 17 / 116,905, filed December 9, 2020, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates to consumer and medical devices, systems, and methods. In particular, the present disclosure relates to devices and associated systems and methods for monitoring a human's physiological condition, and more particularly to such devices, systems, and methods for electrocardiogram (ECG), heart rate, and arrhythmia monitoring utilizing computing devices, such as personal computers, laptop computers, tablet computers, smartphones, wearable computing devices, and the like. [Background technology]

[0003] Cardiovascular disease is the leading cause of death in the world. Thirty percent of deaths worldwide in 2008 can be attributed to cardiovascular disease. It is also estimated that by 2030, more than 23 million people will die from cardiovascular disease annually. Cardiovascular disease is equally prevalent in people in high-income and low-income countries.

[0004] Arrhythmia is a cardiac condition in which the heart's electrical activity is irregular, or faster (tachycardia) or slower (bradycardia) than normal. While many arrhythmias are not life-threatening, some can cause cardiac arrest and even sudden cardiac death. In fact, arrhythmias are one of the most common causes of death during transport to the hospital. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent No. 4,221,223 [Patent Document 2] U.S. Patent No. 4,295,472 [Patent Document 3] U.S. Patent No. 4,230,127 [Patent Document 4] U.S. Patent No. 4,938,228 [Patent Document 5] U.S. Patent No. 5,351,695 [Patent Document 6] U.S. Patent No. 5,333,616 [Patent Document 7] U.S. Patent No. 5,317,269 [Patent Document 8] U.S. Patent No. 5,289,824 [Patent Document 9] U.S. Patent No. 5,735,285 [Patent Document 10] U.S. Patent No. 6,264,614 [Patent Document 11] U.S. Patent No. 6,685,633 [Patent Document 12] U.S. Patent No. 6,790,178 [Patent Document 13] U.S. Patent No. 8,301,232 [Patent Document 14] U.S. Patent No. 8,509,882 [Patent Document 15] U.S. Patent No. 8,615,290 [Patent Document 16] US Patent Application Publication No. 2011 / 0015496 [Patent Document 17] U.S. Patent Application Serial No. 12 / 796,188 [Patent Document 18] U.S. Patent Application Serial No. 13 / 108,738 [Patent Document 19] US Patent Application Publication No. 2011 / 0301439-A1 [Patent Document 20] US Patent Application Publication No. 2011 / 0301435 [Patent Document 21] US Patent Application Publication No. 2011 / 0301439 [Patent Document 22] International Application Publication No. 2013 / 023370 [Patent Document 23] U.S. Provisional Patent Application No. 61 / 845,254 [Patent Document 24] U.S. Provisional Patent Application No. 61 / 872,555 [Patent Document 25] U.S. Patent No. 5,481,255 [Patent Document 26] U.S. Patent No. 5,452,356 Summary of the Invention [Means for solving the problem]

[0006] The novel features of the present disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of such embodiments. [Brief description of the drawings]

[0007] [Figure 1] FIG. 1 is a schematic diagram of a system for measuring and monitoring biometric or physiological parameters, according to many embodiments. [Figure 2A] FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system comprising a smartphone and a smartphone protective case, according to many embodiments. [Figure 2B] FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system comprising a smartphone and a smartphone protective case, according to many embodiments. [Figure 2C] FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system comprising a smartphone and a smartphone protective case, according to many embodiments. [Figure 2D]FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system comprising a smartphone and a smartphone protective case, according to many embodiments. [Figure 2E] FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system comprising a smartphone and a smartphone protective case, according to many embodiments. [Figure 2F] FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system comprising a smartphone and a smartphone protective case, according to many embodiments. [Figure 2G] FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system comprising a smartphone and a smartphone protective case, according to many embodiments. [Figure 2H] FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system comprising a smartphone and a smartphone protective case, according to many embodiments. [Figure 2I] FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system comprising a smartphone and a smartphone protective case, according to many embodiments. [Figure 2J] FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system comprising a smartphone and a smartphone protective case, according to many embodiments. [Figure 2K] FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system comprising a smartphone and a smartphone protective case, according to many embodiments. [Figure 3A] FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system including a tablet computer and a tablet computer protective case, according to many embodiments. [Figure 3B]FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system including a tablet computer and a tablet computer protective case, according to many embodiments. [Figure 3C] FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system including a tablet computer and a tablet computer protective case, according to many embodiments. [Figure 3D] FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system including a tablet computer and a tablet computer protective case, according to many embodiments. [Figure 3E] FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system including a tablet computer and a tablet computer protective case, according to many embodiments. [Figure 3F] FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system including a tablet computer and a tablet computer protective case, according to many embodiments. [Figure 4A] FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system that includes a keyboard and keyboard accessory of a computing device, according to many embodiments. [Figure 4B] FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system that includes a keyboard and keyboard accessory of a computing device, according to many embodiments. [Figure 4C] FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system that includes a keyboard and keyboard accessory of a computing device, according to many embodiments. [Figure 5A] FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system comprising a laptop or palmtop computer and a sensor accessory, according to many embodiments. [Figure 5B] FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system comprising a laptop or palmtop computer and a sensor accessory, according to many embodiments. [Figure 5C] FIG. 1 illustrates a biometric or physiological parameter measurement and monitoring system comprising a laptop or palmtop computer and a sensor accessory, according to many embodiments. [Figure 6] FIG. 1 illustrates a method for biometric or physiological parameter measurement and observation, according to many embodiments. [Figure 7] FIG. 1 is a pictorial representation of the body showing examples of electrode placement for taking a standard 12-lead ECG. [Figure 8] FIG. 1 is a pictorial representation of the chest showing example electrode placement on the chest for taking a 12-lead ECG (showing positioning for V6-V12). [Figure 9A] FIG. 1 is a front view of one variation of an apparatus as described herein (in this example, a wireless mobile telecommunications device is shown being inserted into the apparatus configured as a case). [Figure 9B] FIG. 9B is a left side view of the device of FIG. 9A. [Figure 9C] FIG. 9B is a rear view of the device of FIG. 9A. [Figure 9D] FIG. 9B is a right side view of the device of FIG. 9A. [Figure 10A] FIG. 1 is a front view of another variation of an apparatus as described herein, shown empty but configured as a case adapted to hold a mobile telecommunications device. [Figure 10B] FIG. 4B is a left side view of the device of FIG. 4A (in this example, the leg (first) electrode is on the left side of the case); [Figure 10C] FIG. 4B is a rear view of the device of FIG. 4A. [Figure 10D] FIG. 4B is a right side view of the device of FIG. 4A. [Figure 11A]FIG. 1 shows another variation of a device as described herein from a left side view (in this example, the leg (first) electrode is on the edge between the rear and left side of the case). [Figure 11B] FIG. 13 illustrates another variation of a device as described herein from a rear view. [Figure 11C] FIG. 13 illustrates another variation of a device as described herein from a right side view. [Figure 12A] FIG. 2 illustrates another variation of a device as described herein from a left side view (in this example, the leg (first) electrode is on the back and adjacent to the left side). [Figure 12B] FIG. 13 illustrates another variation of a device as described herein from a rear view. [Figure 12C] FIG. 13 illustrates another variation of a device as described herein from a right side view. [Figure 13A] FIG. 1 shows another variation of a device as described herein from a left side view (in this example, the leg (first) electrode is on the edge between the rear and left side of the case). [Figure 13B] FIG. 13 illustrates another variation of a device as described herein from a rear view. [Figure 13C] FIG. 13 shows another variation of a device as described herein from a right side view. [Figure 14A] FIG. 2 shows another variation of a device as described herein from a left side view (in this example, the leg (first) electrode is on the left side of the case, and the second and third electrodes are part of an electrode unit held by the case on the back). [Figure 14B] FIG. 13 illustrates another variation of a device as described herein from a rear view. [Figure 14C] FIG. 13 illustrates another variation of a device as described herein from a right side view. [Figure 15A]FIG. 1 shows another variation of a device as described herein from a left side view (in this example, the leg (first) electrode is on the back between the second and third electrodes). [Figure 15B] FIG. 13 illustrates another variation of a device as described herein from a rear view. [Figure 15C] FIG. 13 illustrates another variation of a device as described herein from a right side view. [Figure 16A] FIG. 1 shows another variation of a device as described herein from a front view (in this example, the leg (first) electrode is on a cord extendable from the body of the device for attachment to the leg). [Figure 16B] FIG. 13 illustrates another variation of a device as described herein from a rear view. [Figure 17] FIG. 13 illustrates the application of one variation of the device for detecting ECG described herein, in which the leg electrodes are held against the patient's legs so that they contact the legs while the patient's hands are in contact with the left and right electrodes, respectively, on the back of the device. [Figure 18] A pictorial representation of human hearing range and thresholds from http: / / en.labs.wikimedia.org / wiki / Acoustics. [Figure 19] Pictorial representation of age-related hearing loss from www.neuroreille.com / promenade / english / audiometry / audiometry.htm. [Figure 20] Audiogram showing common sound intensities and frequencies from www.hearinglossky.org / hlasurvivall.html. [Figure 21A] FIG. 1 is a schematic representation of a system configured to ultrasonically transmit digital data encoding one or more biological parameters to a remote communication device, such as a smartphone. [Figure 21B]FIG. 1 is a schematic representation of a system including a medical sensing device configured to ultrasonically transmit data encoding one or more biological parameters to a remote communication device, such as a smartphone. [Figure 21C] FIG. 1 is a schematic representation of a system including a medical sensing device configured to ultrasonically transmit and receive data encoding one or more biological parameters (e.g., ECG data) to a remote communication device such as a smartphone. [Figure 22] FIG. 1 shows one variation of a digital signal encoded using frequency shift keying in the ultrasonic range as described. [Diagram 23] 1 is an exemplary flow chart illustrating one method of transmitting encoded data as an ultrasound signal. [Figure 24A] 1 is an example flow chart of a method for transmitting a signal as an ultrasound signal (eg, packet transmission). [Figure 24B] 1 is an example flow chart of a method for transmitting a signal as an ultrasound signal (eg, packet transmission). [Figure 24C] 1 is an example flow chart of a method for transmitting a signal as an ultrasound signal (eg, packet transmission). [Figure 24D] 1 is an example flow chart of a method for transmitting a signal as an ultrasound signal (eg, packet transmission). [Figure 24E] 1 is an example flow chart of a method for transmitting a signal as an ultrasound signal (eg, packet transmission). [Diagram 25] FIG. 2 illustrates an example of a flowchart of a demodulator and packet decoder for a receiver configured to receive and decode data transmitted by ultrasound as discussed herein. [Figure 26A] FIG. 1 illustrates one exemplary format of a hybrid digital and analog ultrasound data format. [Figure 26B]FIG. 1 illustrates another exemplary format of a hybrid digital and analog ultrasound data format. [Figure 27] A schematic diagram of a system for secure ultrasonic transmission of data including an ultrasonic communication device with an ultrasonic transducer, an encryption key located on the ultrasonic communication device, and decryption logic executable on a remote communication device, the remote communication device having a receiver for receiving ultrasonic signals from the ultrasonic communication device. [Figure 28A] FIG. 1 illustrates one variation of a wristlet device for sensing one or more biological parameters and wirelessly transmitting it to a mobile communication / computing device at extremely low power (showing an outside view of the wristlet). [Figure 28B] FIG. 1 illustrates one variation of a wristlet device for sensing one or more biological parameters and transmitting it wirelessly at very low power to a mobile communication / computing device (showing a schematic diagram of the inner area containing various modules for sensing power and transmission of ultrasound signals, many of these elements are optional). [Figure 29] FIG. 1 illustrates one variation of a wristlet configured as a watch for detecting ECG signals. [Diagram 30] FIG. 30 shows the wristlet of FIG. 29 in communication (via ultrasound) with a mobile telecommunications device to transmit ECG information. [Diagram 31] 1 is a flow diagram of a method for performing a 12-lead ECG using a three-electrode device, according to some embodiments of the present disclosure. [Diagram 32] 1 is a flow diagram of a method for machine learning training of 12-lead ECG with a three-electrode device, according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] SUMMARY OF THE DISCLOSURE Devices, systems and methods for measuring and monitoring biometric or physiological parameters are disclosed that are user friendly and convenient.

[0009] It is to be understood that the disclosure is not limited in application to the details of construction, experiments, example data, and / or component arrangements set forth in the following description. The disclosed invention is capable of other embodiments or of being practiced or carried out in various ways. It is also to be understood that the terminology employed herein is for the purpose of description and should not be regarded as limiting.

[0010] In the following detailed description of the embodiments of the present disclosure, numerous specific details are set forth in order to provide a more complete understanding of the present disclosure. However, it will be apparent to those skilled in the art that the concepts within the present disclosure may be practiced without these specific details. In other instances, well-known features have not been described in detail in order to avoid unnecessarily complicating the description.

[0011] Atrial fibrillation (A-fib) is the most common arrhythmia. In A-fib, electrical conduction through the ventricles is irregular and disrupted. A-fib may not cause symptoms, but is often associated with palpitations, shortness of breath, fainting, chest pain, or congestive heart failure, and also increases the risk of stroke. A-fib is usually diagnosed by taking an electrocardiogram (ECG) of the subject. To treat A-fib, patients may take medicines to slow the heart rate or regulate the heart's rhythm. Patients may also take blood thinners to prevent strokes, or undergo surgical procedures, including heart resection, to treat A-fib.

[0012] Often, patients with arrhythmia or A-fib are monitored for extended periods of time to manage the disease. For example, patients may be provided with a Holter monitor or other ambulatory electrocardiogram recording device to continuously monitor the electrical activity of their cardiovascular system for at least 24 hours.

[0013] Electrocardiography is used to study the electrical activity of the heart and can be used for both diagnosis and treatment. An electrocardiogram (ECG) can be recorded, or taken, using electrodes placed at multiple locations on the patient's skin. The electrical signals recorded between electrode pairs are called leads. A variable number of leads can be used to take an ECG, and different combinations of electrodes can be used to form various leads. Examples of leads used to take an ECG are one, three, five, and twelve leads. In a 12-lead ECG, ten electrodes may be used: six on the patient's chest and one on each of the arms and legs.

[0014] There are various "standard" configurations of electrode placement that may be used to attach electrodes to a patient. For example, the arm and leg electrodes may be placed closer to the chest or closer to the end of the arm / leg. Various placements of the electrodes on the arms and legs may affect the ECG and make standard ECGs more difficult to compare.

[0015] A standard or conventional 12-lead ECG configuration uses ten electrodes. FIG. 1 shows a pictorial representation of the ten electrodes, six electrodes on the patient's chest and one electrode on each of the patient's arms and legs. The electrode placed on the right arm may be referred to as RA. The electrode placed on the left arm may be referred to as LA. The RA and LA electrodes are placed in the same location for the left and right arms, preferably near the wrist. The leg electrodes may be referred to as RL for the right leg and LL for the left leg. The RL and LL electrodes are placed in the same location for the left and right legs, preferably near the ankle.

[0016] In another embodiment, the 12-lead ECG may be generated using three electrodes (e.g., by a device including three electrodes). For example, in one embodiment, a device with three electrodes as described herein may be used to determine lead I (e.g., the voltage between the left arm and the right arm) simultaneously with lead II (e.g., the voltage between the left leg and the right arm) and to determine lead I simultaneously with another one of the chest leads, such as lead V2 or V5. In other embodiments, any other combination of leads is possible. The processing logic may then time-align the two sets of recordings using lead I or another lead common in the measurements, allowing the two sets of measurements to be compared over the same simulated time period.

[0017] The processing logic may further transform the two sets of leads to generate a complete 12-lead ECG. In one embodiment, the processing logic may perform such transformation using a machine learning model (e.g., neural network, deep learning techniques, etc.). The machine learning model may be trained using 12-lead ECG data corresponding to a population of individuals. The data may be pre-processed to filter the data in a manner appropriate for the application before being input to the machine learning model. For example, the data may be classified according to height, sex, weight, nationality, etc. before being used to train one or more machine learning models, so that the resulting model or models are fine-tuned for the particular type of individual. In a further embodiment, the machine learning model may be further trained based on a user's unique ECG data to fine-tune and personalize the model and further reduce any residual synthesis errors.

[0018] In one embodiment, using the machine learning techniques described herein, a complete 12-lead ECG can be generated using only three electrodes in a single form factor. As described herein, the three electrodes may be arranged on the device in any suitable manner, including two electrodes on the front and one on the back of the device.

[0019] 7 and 8 show the placement of six electrodes on the chest, labeled V1, V2, V3, V4, V5, and V6. V1 is placed, for example, in the fourth intercostal space between ribs 4 and 5, immediately to the right of the sternum. V2 is placed, for example, in the fourth intercostal space between ribs 4 and 5, immediately to the left of the sternum. V3 is placed between electrodes V2 and V4. V4 is placed in the fifth intercostal space between ribs 5 and 6 on the midclavicular line. V5 is placed at the same height as V4 on the left axillary line. V6 is placed at the same height as V4 and V5 on the midclavicular line.

[0020] Lead I is usually the voltage between the left arm (LA) and the right arm (RA), e.g., I=LA-RA. Lead II is usually the voltage between the left leg (LL) and the right arm (RA), e.g., II=LL-RA. Lead III is usually the voltage between the left leg (LL) and the left arm (LA), e.g., III=LL-LA. Wilson's center electrode (WCT or VW) can be calculated by (RA+LA+LL) / 3. Given that both leads I and II are recorded relative to RA so that the voltage at RA can be considered 0, WCT (VW) can be calculated as lead I+lead II / 3.

[0021] Augmented limb leads can also be determined from RA, RL, LL, and LA. The augmented vector right (aVR) is equal to RA-(LA+LL) / 2 or -(I+II) / 2. The augmented vector left (aVL) is equal to LA-(RA+LL) / 2 or I-II / 2. The augmented vector foot (aVF) is equal to LL-(RA+LA) / 2 or II-I / 2.

[0022] I, II, III, aVR, aVL, and aVF can all be represented in a 6-axis system. Misplacement or misalignment of the electrodes can change ECG results in a 6-axis system.

[0023] However, current ambulatory electrocardiogram recording devices, such as Holter monitors, are typically bulky and difficult for a subject to attach without the assistance of a medical professional. For example, use of a Holter monitor requires the patient to wear a large device on their chest and precise placement of multiple electrodes in precise locations on the chest. These requirements may interfere with the subject's activities, including natural movement, bathing, and showering. Once a full-disclosure ECG is generated, the ECG is transmitted to the patient's physician, who then analyzes the ECG and makes a diagnosis and other recommendations. Currently, this process often must be performed through hospital administrators and health care organizations, and many patients do not receive feedback in a convenient manner.

[0024] Several handheld ECG measurement devices are known, including devices that can adapt existing mobile telecommunications devices (e.g., smartphones) so that they can be used to record ECGs. However, such devices either require the use of external (e.g., plug-in) electrodes or contain electrodes within the housing that are difficult to properly hold and attach to the body.

[0025] Wearable monitors for detecting one or more biometric parameters (including subject movement, heart rate, temperature, ECG, etc.) must typically communicate wirelessly to an observation, analysis, or recording station ("observation station"). Typically, the transmission of information is performed by short wavelength radio transmission (e.g., "Bluetooth"). In particular, although some of the embodiments are described with respect to ultrasonic communication, it is believed that Bluetooth communication is at least equally applicable to the described technology, and ultrasonic is only proposed as a non-limiting example of any number of other suitable communication technologies. It is believed that one skilled in the art would so recognize.

[0026] In some situations where it is desirable for the device to be lightweight so that it can be worn comfortably during normal daily activities or exercise, many manufacturers choose to record the data rather than transmit it, and periodically download the data via a direct connection to an observation station. It would be advantageous to provide an observation device that can be worn by the subject on the wrist (e.g., a wristlet), or other body area that allows for reliable low energy wireless transmission of data.

[0027] For example, cardiac monitoring devices such as those described in U.S. Pat. Nos. 4,221,223, 4,295,472, and 4,230,127 describe wristwatch-sized wearable monitors that can detect ECG signals from a patient wearing the device. These signals may be displayed on the device. These signals are not transmitted. Another similar device is described in U.S. Pat. No. 4,938,228. U.S. Pat. Nos. 5,351,695, 5,333,616, 5,317,269, and 5,289,824 (all to Mills) describe improvements to this device, which include an integrated hearing aid-type speaker to transmit the ECG signal over the telephone line using audible tones (e.g., between 1 kHz and 3 kHz) and sound over the telephone's voice channel. The ECG signal is typically digitized and frequency modulated (e.g., as a frequency shift keyed signal). Unfortunately, such devices are literally noisy, require large amounts of power to generate and transmit an audible signal, and do not allow two-way communication, especially with mobile telecommunications devices.

[0028] The following patent documents may also be relevant: U.S. Patent Nos. 5,735,285, 6,264,614, 6,685,633, 6,790,178, 8,301,232, 8,509,882, and 8,615,290, and U.S. Patent Application Publication No. 2011 / 0015496.

[0029] Although ultrasonic transmission shares many similarities with electrical transmission, there are also significant differences, including differences previously considered to be disadvantages. Furthermore, while techniques such as frequency shift keying for digitizing information are known, implementing such techniques on timescales that would make them practical for use in medical (e.g., ECG) monitoring has been difficult and impractical. In particular, transmission of ultrasound data has, to date, been somewhat limited in information content. For example, digital encoding of information by ultrasound has been limited in the amount and content of information transmitted. There are also no standards yet for the transmission or encoding of ultrasonic transmissions. Furthermore, such ultrasonic signals are not routinely encrypted.

[0030] It would therefore be advantageous to provide systems, devices, and methods for encoding or organizing information transmitted by ultrasonic transmissions. In particular, it would be advantageous to encode the information in a manner that avoids the limitations of ultrasonic (as opposed to electromagnetic or audible) transmissions. In addition, it would be useful to provide methods, devices, and systems for securely transmitting (e.g., encrypting and / or decrypting) ultrasonic transmissions. For example, it would be useful to dynamically pair a device (e.g., a wristlet) that transmits ECG information ultrasonically with one or more receiving devices.

[0031] Described herein are methods, devices, and systems for using (or adapting for use with) one or more widely available telecommunications devices (including mobile telecommunications devices), such as smartphones, tablet computers, portable computers, or desktop computers, to receive and transmit information (including, but not limited to, digital health information) that is encoded by an application device into an ultrasound signal that can be heard by the telecommunications device, and then stored, transmitted, and / or analyzed by the telecommunications device. In particular, described herein are methods, devices, and systems for encoding information such that only a telecommunications device that has been provided with a key can interpret this information. The systems, devices, and methods (including executable logic) may include techniques for easily providing the key using a modality other than ultrasound transmission (e.g., optical).

[0032] U.S. Patent Application No. 12 / 796,188, entitled "HEART MONITORING SYSTEM USABLE WITH A SMART PHONE OR COMPUTER," filed June 8, 2010, now U.S. Patent No. 8,509,882, and U.S. Patent Application No. 13 / 108,738, entitled "WIRELESS, ULTRASONIC PERSONAL HEALTH MONITORING SYSTEM," filed May 16, 2011, now U.S. Patent Application Publication No. US / 2011 / 0301439-A1, describe an ECG monitor that converts ECG data into an ultrasound signal that can be received by a remote communication device, such as a smartphone, and then stored, analyzed, and / or displayed. The present application extends and adapts this teaching and may be used with any of the systems, methods, and devices described herein.

[0033] Therefore, there is a need for improved cardiac disease and / or cardiac rhythm management and monitoring devices, systems, and methods that address one or more of the above problems.

[0034] Disclosed are devices, systems, and methods for measuring and observing biometric or physiological parameters in a user-friendly and convenient manner. In particular, a user's relevant physiological parameters may be measured while the user is normally operating a computing device or other manual or handheld device. For example, the disclosed system may enable a user's one or more physiological parameters to be measured while the user is normally operating a computing device such as a laptop, tablet computer, or smartphone. The one or more physiological parameters may be measured using a computing device accessory such as a laptop case, tablet computer case, smartphone case, etc. Normal use of a computing device may include web browsing, reading and writing emails or text messages, playing games, or otherwise using other common applications such as books or text readers. The disclosed physiological parameter observation and measurement application may run in the background while the computing device is normally used.

[0035] Aspects of the present disclosure provide a system for measuring a cardiac parameter of a user. The system may include an apparatus configured to couple to a computing device and a first application loaded onto the computing device. The apparatus may include a sensor for measuring the cardiac parameter. The first application may be configured to receive the measured cardiac parameter from the sensor. The sensor may measure the cardiac parameter and the first application may receive the measured cardiac parameter at the same time that a second application is loaded onto the computing device and operated by a user.

[0036] The cardiac parameters may comprise one or more of heart rate, heart rate variability, blood pressure, blood pressure variability, arrhythmia, oscilloscope cardiogram (SCG), SCG parameters, electrocardiogram (ECG), or ECG parameters. In many embodiments, the cardiac parameters comprise electrocardiogram (ECG) or ECG parameters.

[0037] The computing device may comprise one or more of a personal computer, a laptop computer, a tablet computer, a personal digital assistant (PDA), a smartphone, or a wearable computing device. In many embodiments, the computing device comprises a tablet computer or a smartphone. The apparatus may be configured to removably couple to the computing device and may comprise a cover for covering the computing device, such as a tablet computer case or a smartphone case or cover.

[0038] The sensor for measuring the cardiac parameter may comprise a first and a second electrode configured to generate a signal comprising the cardiac parameter upon contact with a user. For example, the first electrode may be configured to contact the right arm of a user and the second electrode may be configured to contact the left arm of a user to generate a lead I ECG. Alternatively or in combination, the first electrode may be configured to contact the right arm of a user and the second electrode may be configured to contact the left leg of a user to generate a lead II ECG. Alternatively or in combination, the first electrode may be configured to contact the left arm of a user and the second electrode may be configured to contact the left leg of a user to generate a lead III ECG. The sensor may further comprise a third electrode for contact configured to generate a signal comprising the cardiac parameter upon contact with a user. The first, second and third electrodes may be used simultaneously to generate, for example, one or more of a lead I, lead II or lead III ECG. The first electrode may be configured to contact the user's right arm, the second electrode may be configured to contact the user's left arm, and the third electrode may be configured to contact the user's left leg.

[0039] The first application may be further configured to display the measured cardiac parameters, for example, on a display of the computing device. The cardiac parameters may be displayed in real time. The first application may be further configured for storing the measured cardiac parameters in a memory of the computing device. The first application may be further configured for transmitting the measured cardiac parameters to a remote computing device, such as a remote server. The remote computing device may store cardiac or other physiological parameter data and enable access to such data by medical professionals and other skilled persons for analysis, interpretation, and / or diagnosis of the data. The analysis and diagnosis may be returned to the user through the remote computing device and the user's computing device, or through other channels such as email, text messaging, or other electronic alerts. Alternatively, or in combination, one or more of the first application loaded on the computing device, another application loaded on the remote server, or another application used by the medical professional or skilled person may automatically generate an analysis, interpretation, and / or diagnosis of such data.

[0040] Operating the second application may include one or more of typing on the keyboard of the second application, scrolling on the second application, zooming in or out on the second application, inputting data otherwise into the second application, etc. By allowing the user to operate a second application loaded on the computing device while the first application measures and observes the user's cardiac and other health parameters, embodiments of the present disclosure enable user-friendly, convenient, less invasive and less intrusive measurement and observation of cardiac and other health parameters. For example, the user can hold and operate the computing device normally to check email, browse the web, or operate a mobile application, while the first application and the computing device cover measures and / or observes the user's ECG or other cardiac and physiological parameters in the background.

[0041] Aspects of the present disclosure also provide a method for measuring a cardiac parameter of a user. An apparatus with a sensor for the cardiac parameter may be coupled to a computing device. The cardiac parameter of the user may be measured using the sensor. The measured cardiac parameter may be transmitted using the apparatus to a first application loaded on the computing device. At the same time that the user operates a second application loaded on the computing device, the cardiac parameter may be measured and the first application may receive the transmitted measured cardiac parameter.

[0042] The cardiac parameters may comprise one or more of heart rate, heart rate variability, blood pressure, blood pressure variability, arrhythmia, oscilloscope cardiogram (SCG), SCG parameters, electrocardiogram (ECG), or ECG parameters. In many embodiments, the cardiac parameters comprise electrocardiogram (ECG) or ECG parameters.

[0043] The computing device may comprise one or more of a personal computer, a laptop computer, a tablet computer, a personal digital assistant (PDA), a smartphone, or a wearable computing device. In many embodiments, the computing device comprises a tablet computer or a smartphone. The apparatus may be coupled to the computing device by removably attaching the apparatus to the computing device. For example, the apparatus may comprise a cover for covering the computing device, such as a tablet computer case or a smartphone cover. The method may also comprise at least partially enclosing the computing device, such as a tablet computer or smartphone, with a case or cover.

[0044] The cardiac parameter may be measured with the sensor by measuring the cardiac parameter with a first and a second electrode of the sensor. The first and second electrodes may be configured to generate a signal comprising the cardiac parameter upon contacting the user. For example, the first electrode may be configured to contact the right arm of the user and the second electrode may be configured to contact the left arm of the user to generate a Lead I ECG. Alternatively or in combination, the first electrode may be configured to contact the right arm of the user and the second electrode may be configured to contact the left leg of the user to generate a Lead II ECG. Alternatively or in combination, the first electrode may be configured to contact the left arm of the user and the second electrode may be configured to contact the left leg of the user to generate a Lead III ECG. The cardiac parameter may also be measured with a third electrode of the sensor, the third electrode configured to generate a signal comprising the cardiac parameter upon contacting the user. The first, second, and third electrodes may be used simultaneously to generate one or more of, for example, a Lead I, a Lead II, or a Lead III ECG. The first electrode may be configured to contact the user's right arm, the second electrode may be configured to contact the user's left arm, and the third electrode may be configured to contact the user's left leg.

[0045] Further, the received measured cardiac parameters may be displayed on a display of the computing device. The cardiac parameters may be displayed in real time. The measured cardiac parameters may also be stored in a memory of the computing device. The measured cardiac parameters may also be transmitted to a remote computing device, such as a remote server. The remote computing device may store the cardiac parameter data or other physiological parameter data and allow access to such data by medical professionals and other skilled persons for analysis, interpretation, and / or diagnosis of the data. The analysis and diagnosis may be returned to the user through the remote computing device and the user's computing device, or through other channels such as email, text messaging, or other electronic alerts. Alternatively, or in combination, one or more of the first application loaded on the computing device, another application loaded on the remote server, or another application used by the medical professional or skilled person may automatically generate an analysis, interpretation, and / or diagnosis of such data.

[0046] The operation of the second application may include one or more of typing on the keyboard of the second application, scrolling on the second application, zooming in or out on the second application, inputting data otherwise into the second application, etc. By allowing the user to operate the second application loaded on the computing device while the first application measures and observes the user's cardiac and other health parameters, the embodiments of the present disclosure enable user-friendly, convenient, less invasive and less intrusive measurement and observation of cardiac and other health parameters. For example, the user may hold and operate the computing device normally to check email, browse the web, or operate mobile applications, while the first application and the cover of the computing device measures and / or observes the user's ECG or other cardiac and physiological parameters in the background. In some embodiments, the first application may cause the computing device to warn the user (i.e., a pop-up may appear in the second application) if the health parameter sensor is misplaced and therefore cannot or should not be able to make a proper measurement.

[0047] Aspects of the present disclosure also provide a system for measuring a cardiac parameter of a user. The system may include a cover configured to be removably attached to a portable computing device. The portable computing device may include a front side, a back side, and an edge between the front side and the back side. The cover may include a plurality of sensor electrodes configured to measure the cardiac parameter and disposed on the edge of the portable computing device when the cover is attached to the portable computing device. In many embodiments, the plurality of sensor electrodes are disposed only on the edge of the portable computing device. The portable computing device may include a laptop computer, a tablet computer, a personal digital assistant (PDA), or a smartphone.

[0048] The cardiac parameters may comprise one or more of heart rate, heart rate variability, blood pressure, blood pressure variability, arrhythmia, oscilloscope cardiogram (SCG), SCG parameters, electrocardiogram (ECG), or ECG parameters. In many embodiments, the cardiac parameters comprise electrocardiogram (ECG) or ECG parameters.

[0049] The plurality of sensor electrodes may include a first sensor electrode and a second sensor electrode. The first sensor electrode and the second sensor electrode may be configured to generate a signal comprising a cardiac parameter when contacting a first limb and a second limb of a user, respectively. For example, the first electrode may be configured to contact a right arm of a user, and the second electrode may be configured to contact a left arm of a user to generate a lead I ECG. Alternatively, or in combination, the first electrode may be configured to contact a right arm of a user, and the second electrode may be configured to contact a left leg of a user to generate a lead II ECG. Alternatively, or in combination, the first electrode may be configured to contact a left arm of a user, and the second electrode may be configured to contact a left leg of a user to generate a lead III ECG. The plurality of sensor electrodes may further include a third sensor electrode configured to generate a signal comprising a cardiac parameter when contacting a third limb of a user. The cardiac parameter may also be measured using a third electrode of the sensor, the third electrode being configured to generate a signal comprising the cardiac parameter upon contact with a user. The first, second, and third electrodes may be used simultaneously to generate, for example, one or more of a Lead I, Lead II, or Lead III ECG.

[0050] The system may further comprise a first application loaded onto the portable computing device. The first application may be configured to receive the measured cardiac parameters from the multiple sensor electrodes. The first application may receive the measured cardiac parameters at the same time that the second application is loaded onto the portable computing device and operated by the user. Operating the second application may include one or more of typing on the keyboard of the second application, scrolling on the second application, zooming in or out on the second application, inputting data otherwise into the second application, and the like. By allowing the user to operate the second application loaded onto the computing device while the first application measures and observes the user's cardiac and other health parameters, embodiments of the present disclosure enable user-friendly, convenient, less invasive and intrusive measurement and observation of cardiac and other health parameters. For example, the user may hold and operate the computing device normally to check email, browse the web, or operate a mobile application while the first application and the cover of the computing device measure and / or observe the user's ECG or other cardiac and physiological parameters in the background.

[0051] The first application may be configured to display the received cardiac parameters on a display of the portable computing device. The received cardiac parameters may be displayed in real time. The first application may be further configured to store the measured cardiac parameters in a memory of the portable computing device. The first application may be further configured to transmit the measured cardiac parameters to a remote computing device, such as a remote server. The remote computing device may store the cardiac parameter data or other physiological parameter data and enable access to such data by medical professionals and other skilled persons for analysis, interpretation, and / or diagnosis of the data. The analysis and diagnosis may be returned to the user through the remote computing device and the user's computing device, or through other channels such as email, text messaging, or other electronic alerts. Alternatively, or in combination, one or more of the first application loaded on the computing device, another application loaded on the remote server, or another application used by the medical professional or skilled person may automatically generate an analysis, interpretation, and / or diagnosis of such data.

[0052] Aspects of the present disclosure also provide a method for measuring a cardiac parameter of a user. A cover may be removably attached to a portable computing device. The portable computing device may include a front surface, a back surface, and an edge between the front surface and the back surface. A first and a second electrode of the cover may contact a first and a second extremity of the user, respectively, to generate a signal comprising the cardiac parameter. The first and the second electrodes of the cover may be disposed on an edge of the portable computing device. In many embodiments, the plurality of sensor electrodes may be disposed only on an edge of the portable computing device. The portable computing device may include a laptop computer, a tablet computer, a personal digital assistant (PDA), or a smartphone.

[0053] The cardiac parameters may comprise one or more of heart rate, heart rate variability, blood pressure, blood pressure variability, arrhythmia, oscilloscope cardiogram (SCG), SCG parameters, electrocardiogram (ECG), or ECG parameters. In many embodiments, the cardiac parameters comprise electrocardiogram (ECG) or ECG parameters.

[0054] A third electrode may contact a third limb of the user to generate a signal comprising a cardiac parameter. The first limb may comprise the right arm, the second limb may comprise the left arm, and the third limb may comprise the left leg. These three limbs may be simultaneously contacted with the first, second, and third electrodes, respectively, to simultaneously generate a Lead I ECG, a Lead II ECG, and a Lead III ECG. Alternatively, the first and second electrodes may be used to generate a Lead I ECG, a Lead II ECG, and a Lead III ECG. For example, the first electrode may be configured to contact the user's right arm and the second electrode may be configured to contact the user's left arm to generate a Lead I ECG. Alternatively, or in combination, the first electrode may be configured to contact the user's right arm and the second electrode may be configured to contact the user's left leg to generate a Lead II ECG. Alternatively, or in combination, the first electrode may be configured to contact the user's left arm and the second electrode may be configured to contact the user's left leg to generate a Lead III ECG.

[0055] The first application may be loaded onto a tablet computer or smartphone. The first application may be configured to receive cardiac parameters measured from the multiple sensor electrodes. The first application may receive the measured cardiac parameters at the same time that the second application is loaded onto the computing device and operated by the user. Operating the second application may include one or more of typing on the keyboard of the second application, scrolling on the second application, zooming in or out on the second application, inputting data otherwise into the second application, and the like. By allowing the user to operate the second application loaded onto the computing device while the first application measures and observes the user's cardiac and other health parameters, embodiments of the present disclosure enable user-friendly, convenient, less invasive and less intrusive measurement and observation of cardiac and other health parameters. For example, the user may hold and operate the computing device normally to check email, browse the web, or operate a mobile application while the first application and the cover of the computing device measure and / or observe the user's ECG or other cardiac and physiological parameters in the background.

[0056] The received cardiac parameters may be displayed using the first application on a display of the tablet computer or smartphone. The received cardiac parameters may be displayed in real time. The measured cardiac parameters may be stored in a memory of the computing device. The measured cardiac parameters may be transmitted to a remote computing device, such as a remote server. The remote computing device may store cardiac or other physiological parameter data and allow access to such data by medical professionals and other skilled persons for analysis, interpretation, and / or diagnosis of the data. The analysis and diagnosis may be returned to the user through the remote computing device and the user's computing device, or through other channels such as email, text messaging, or other electronic alerts. Alternatively, or in combination, one or more of the first application loaded on the computing device, another application loaded on the remote server, or another application used by the medical professional or skilled person may automatically generate an analysis, interpretation, and / or diagnosis of such data.

[0057] Aspects of the present disclosure also provide a system for measuring a user's cardiac parameters. The system may include a sensor device and an application. The device may be configured to couple to a keyboard of a computing device, a steering wheel of a motorized vehicle, or a handlebar of an exercise machine such as a bicycle, a motorbike, a treadmill or elliptical machine, or a weightlifting machine, a seat, a chair, glasses, clothing, or the like. The device may include a sensor for measuring the cardiac parameters. The device may be configured to receive the measured cardiac parameters from the sensor when the keyboard of the computing device, the steering wheel of the motorized vehicle, the handlebar of the bicycle, the motorbike, or the exercise machine is touched, held, or manipulated. Additional methods and systems are also contemplated for conveniently, non-invasively, and non-intrusively measuring and observing cardiac and other physiological parameters while the user normally operates a computing device or other device in contact with the user's body.

[0058] The present disclosure also describes apparatus, including systems, software, and devices for taking electrocardiogram (ECG) information from a subject using an interface compatible with a mobile telecommunications device having three electrodes, as well as methods, including methods for using these apparatus. Described herein is an apparatus for detecting ECG that can address problems, including but not limited to those identified above, with currently available ECG sensing systems.

[0059] In general, the apparatus (including devices and systems) and methods described herein are for use in detecting biological signals, such as an electrocardiogram (ECG). In particular, apparatuses are described herein for use with a mobile telecommunications device, such that the mobile telecommunications device may receive biological signals measured directly from a patient. The apparatus typically includes three or more electrodes (or just three electrodes) for receiving signals, such as voltage or current, from the patient's body. The apparatus may also include a housing. The housing, such as a "case," may be configured to hold or directly connect to the mobile telecommunications device. One or more electrodes may be disposed directly on an exterior surface of the housing. The apparatus may also include one or more transmitters for a sensed communication signal, including a modified / processed version of the sensed signal, from the electrodes to the mobile telecommunications device. The mobile telecommunications device may be connected to the housing, e.g., in or near a case formed by the housing. In some variations, the apparatus may include one or more processing devices for processing signals detected at the electrodes.

[0060] Any suitable transmitter may be used, including a wireless transmitter. In some variations, the wireless transmitter is an ultrasonic transmitter that may use inaudible ultrasonic waves (e.g., >10 kHz, >12 kHz, 15> kHz, >18 kHz, >19 kHz) that may be received by a microphone of a mobile telecommunications device, transmitted, and / or further processed by the mobile telecommunications device. Examples of such systems are described in U.S. Pat. No. 8,301,232, U.S. Patent Application Publication Nos. 2011 / 0301435 and 2011 / 0301439, and by WO 2013 / 023370, each of which is incorporated herein by reference in its entirety.

[0061] The device described herein may be configured to be held by a patient against a leg (e.g., left or right leg) using both hands to measure six of the "leads" from the patient (Leads I-III, and amplified leads aVR, aVL, aVF). In some variations, the device may be configured to allow the patient to hold the device (encircling the mobile telecommunications device) against a leg (right or left) with both hands and simply view the screen of the mobile telecommunications device while recording independent signals from each of the right arm, left arm, and right or left leg. This allows the patient to receive immediate visual feedback from the device, including providing guidance (using the screen or audio output of the mobile telecommunications device) to adjust or correct electrode contact or placement and / or display one or more ECG signals as measurements are made. Thus, the device may be configured as described herein to allow the device to be easily held to enable electrically separate measurements from each arm (right, left) and leg (left or right) and still allow the subject holding the device to observe the screen of the mobile telecommunications device coupled to the device.

[0062] In general, a patient (as used herein) may be a human patient or a non-human patient, including, but not limited to, animals (dogs, cats, horses, etc.) Thus, any of the devices or methods described herein may be used for veterinary applications or configured as veterinary products.

[0063] In general, a mobile telecommunications device may include any mobile telecommunications device, such as a mobile (e.g., cellular) phone or equivalent, including, but not limited to, an iPhone, Droid, etc. A mobile telecommunications device may include a processing device or other computing module / device, which may encompass software, hardware, etc., including machine-readable code configured to operate the device to receive and / or transmit information from the apparatus described herein. Such code may be provided with or separately from the apparatus described. A mobile telecommunications device may be referred to as (and includes) a cell phone or cellular phone, a mobile phone or mobile telephone, a smartphone, a handheld computer, a tablet, a wearable computer, etc. The code may be referred to as software, or application software ("app" or "application"), and may be downloaded from a remote location to the mobile telecommunications device.

[0064] For example, an electrocardiogram (ECG) detection apparatus for use with a wireless telecommunications device is described herein. In some variations, the apparatus includes a case configured to fit over a telecommunications device, the case having an outer back surface, at least two outer sides perpendicular to the back surface, and a front area through which a screen of a telecommunications device held in the case can be viewed; a first electrode on or adjacent to one of the at least two outer sides; a second electrode on the outer back surface, the second electrode having an outer contact surface; and a third electrode on the outer back surface, the third electrode having an outer contact surface, the outer contact surfaces of the second and third electrodes being recessed relative to at least a portion of the outer back surface such that the outer contact surfaces of the second and third electrodes do not contact the table surface when the case is placed on a table surface with the outer back surface facing the table surface; and further, the second and third electrodes are arranged such that a patient can touch the outer contact surface of the second electrode with only his left hand and the outer contact surface of the third electrode with only his right hand and can view the screen of a telecommunications device held in the case while holding the first electrode against his leg.

[0065] When the device is configured as a case, the case may be configured to hold the mobile telecommunications device within a cavity or to be otherwise applied over the mobile telecommunications device. Thus, the case may include an interior surface or a surface for holding the mobile telecommunications device and may have a front area through which the screen and / or any controls of the mobile telecommunications device can be viewed and / or operated. For example, the case may include a cut-out area or a transparent cover through which the mobile telecommunications device can be viewed. The electrodes may be mounted on the case. The case may also include one or more other openings for accessing the controls, inputs, outputs, or connection areas (e.g., jacks, plug-in receptacles, etc.) of the mobile telecommunications device. In general, the electrodes are arranged on the case such that (1) the electrodes are protected from contacting surfaces, particularly metal surfaces, when the device is not in use, and (2) a patient holding the device against a leg to record from both arms (via the hand) and legs simultaneously can contact the electrodes while easily viewing the screen. The case may also house additional components, such as a transmitter as mentioned above, a power source (e.g., a battery, solar cell, etc.), and / or a processing device or other circuitry for conditioning, amplifying, filtering, or otherwise modifying signals received by the electrodes. In some variations, the device may be configured such that one of the electrodes (e.g., the second or third electrode) may serve as a reference electrode for the other two (or possibly more) electrodes.

[0066] In variations such that the case may include one or more mounting areas for one or more of the electrodes. For example, the may include an opening on the back for interfacing with an electrode unit that may be used with cases having various configurations (e.g., to fit mobile telecommunications devices of various sizes). All three electrodes may be part of the same electrode unit, or multiple electrode units may be used. The electrode unit may include additional hardware such as the processing device mentioned, and may also include a power source or other electronic components.

[0067] The second and third electrodes are typically configured so that each can be easily contacted by the patient's hand. For example, the second electrode can be positioned and sized so that the patient can touch the second electrode with the left hand while also touching a third electrode of appropriate shape and size with the right hand. For example, in some variations, the second and third electrodes are entirely on the outer back surface. The second electrode can be in the top / left half of the back of the case (relative to the mobile telecommunications device), while the third electrode is located in the bottom / right half of the back of the case. The second and third electrodes can be separated by a gap sized and / or shaped to prevent overlapping contact with the left hand and contact with the right hand. Generally, the patient should only touch each electrode with one hand.

[0068] The second and third electrodes may be formed of any suitable conductive material (including metals, alloys, etc.) and may be sized so that they may be easily contacted by one or more fingers (or the palm) of a patient holding the device. In some variations, the second and third electrodes are symmetrically positioned relative to one another from the center of the outer dorsal surface.

[0069] The first electrode may be configured such that the first electrode can be easily held against the patient's leg while holding the case and touching the second and third electrodes with the left and right hands, respectively. Thus, in some variations, the first electrode is entirely located on the side of the case (e.g., on one of the at least two outer sides). Alternatively, the first electrode may be on the back of the case but extending along the edge, such that the first electrode can be held against the leg when the edge of the case is held against the leg. Thus, the first electrode may be on the back but abutting or immediately adjacent to a side (one of the at least two outer sides). In some variations, the first electrode curves from the back of the case to the side over the edge of the case, for example along the edge of the case. Thus, the first electrode may extend over the edge between the outer back and one of the outer sides. Any of these configurations may allow the case of the mobile telecommunications device to be held at an angle to the patient's leg so that the patient can hold the case with both hands, touch the second and third electrodes, and make good contact with the leg while looking at the screen of the mobile telecommunications device.

[0070] Thus, in general, the first electrode may extend over the entire or a portion (e.g., more than half) of the length of one side of the case. If the first electrode is on or near the edge of the case and extends over all or a substantial portion (e.g., between about 100% and about 50%, between about 90% and about 60%, about 75%) of the edge of the case, it may be easier to hold and contact the case against the leg as described and shown herein. For example, the outer side of the case may be generally rectangular. The first electrode may be centered between two short sides of one of the outer sides and have a long axis extending in the direction of the long side of one of the outer sides. As mentioned, the first electrode may extend over or near the outer side for more than half the length of the outer side.

[0071] In some variations, the device has only three electrodes (eg, a first, second, and third electrode) on the outer surface of the case.

[0072] In general, the device may be configured such that when the device is placed on a table with the electrodes (first and / or second and third) facing the table, the electrodes do not contact the table surface. This allows the device to be placed on a metal surface, as is common in hospitals or other medical environments, without creating a conductive path between the electrodes and therefore without the possibility of discharge (and / or draining power from the device). In some variations, the electrodes are recessed relative to the outer back surface. For example, the electrodes may be embedded within the material forming the case. Alternatively, or in addition, the case may include one or more protrusions that may support the case when placed on its back, preventing the one or more electrodes from contacting the surface. For example, the outer back surface of the case may include one or more spacers configured to extend a portion of the outer back surface relative to the outer contact surfaces of the first and second surfaces such that the outer contact surfaces are recessed relative to the outer surfaces of the one or more "spacers." In general, a spacer may refer to a protrusion from the back surface that has a height greater than the height of the electrodes, relative to the back surface of the device. For example, the spacers may be bumps, islands, bars, pieces, tabs, etc., extending from the back surface, and in some variations surrounding the electrodes (eg, all or partly surrounding the electrodes).

[0073] In general, the electrodes may have sufficient surface area to easily and reliably contact the patient's hand and / or leg. The first (leg) electrode may be a different shape or size than the second and third electrodes. In some variations, the surface area of ​​the three electrodes is approximately the same. In some variations, the surface area of ​​the second or third (reference) electrode is larger than the other electrodes.

[0074] As mentioned, any of the devices described herein may include a transmitter for communicating with a wireless telecommunication device. The transmitter may be generally wireless, or the transmitter may be directly connected (plugged) to the wireless telecommunication device. Electromagnetic transmitters (including short-range transmitters, radio frequency (RF) transmissions, etc.), optical transmitters, or any other transmission type may be used. In particular, ultrasonic transmitters are described herein that may be integrated into the device.

[0075] For example, described herein is an electromagnetic (ECG) detection apparatus for use with a wireless telecommunications device, the apparatus comprising: a case configured to fit over the telecommunications device, the case having an outer back surface, at least two outer sides perpendicular to the back surface, and a front area through which a screen of a telecommunications device held in the case can be viewed; a first electrode on or adjacent to one of the at least two outer sides; a second electrode on the outer back surface, the second electrode having an outer contact surface; a third electrode on the outer back surface, the third electrode having an outer contact surface; and an ultrasonic transmitter configured to ultrasonically transmit signals sensed from the first, second, and third electrodes to the wireless telecommunications device, the outer contact surfaces of the second and third electrodes being recessed relative to at least a portion of the outer back surface such that the outer contact surfaces of the second and third electrodes do not contact the table surface when the case is placed on a table surface with the outer back surface facing the table surface.

[0076] Methods of using any of the described devices are also described herein. For example, a method of generating an electrocardiogram (ECG) from a patient using a handheld wireless telecommunications device case having three electrodes on an outer surface of the case is described herein, the method comprising the steps of instructing the patient to hold a first electrode extending along the side of the case against the leg while simultaneously touching a second electrode at the back of the case with the right hand and a third electrode at the back of the case with the left hand such that the patient does not touch more than three electrodes on the case, detecting a first lead signal (Lead I) of the ECG between the third electrode and the second electrode, detecting a second lead signal (Lead II) of the ECG between the second electrode and the first electrode, and detecting a third lead signal (Lead III) of the ECG between the first electrode and the third electrode.

[0077] Also described herein is a method of generating an electrocardiogram (ECG) from a patient using a handheld wireless telecommunications device case having three electrodes on an outer surface of the case, the method comprising the steps of instructing the patient to hold a first electrode of the case against a leg while simultaneously touching a second electrode with the right hand and a third electrode with the left hand such that the patient does not touch more than three electrodes on the case, detecting a first lead signal of the ECG (Lead I) between the third electrode and the second electrode, detecting a second lead signal of the ECG (Lead II) between the second electrode and the first electrode, detecting a third lead signal of the ECG (Lead III) between the first electrode and the third electrode, and ultrasonically transmitting the lead signals from the case to the telecommunications device.

[0078] An embodiment of the present disclosure also provides an electrocardiogram (ECG) detection apparatus for use with a wireless telecommunication device. The apparatus may include a case configured to fit over the telecommunication device. The case may have an outer back surface, at least two outer sides perpendicular to the back surface, and a front area through which a screen of a telecommunication device held in the case can be viewed. The apparatus may further include a first electrode on or adjacent one of the at least two outer sides, a second electrode on the outer back surface and having an outer contact surface, and a third electrode on the outer back surface and having an outer contact surface. The outer contact surfaces of the second and third electrodes may be recessed relative to at least a portion of the outer back surface such that the outer contact surfaces of the second and third electrodes do not contact the table surface when the case is placed on a table surface with the outer back surface facing the table surface. Furthermore, the second and third electrodes may be arranged such that the patient can touch the outer contact surface of the second electrode with only the left hand and the outer contact surface of the third electrode with only the right hand, and can also view the screen of a telecommunications device held within the case while holding the first electrode against the leg.

[0079] The second and third electrodes may be entirely on the outer back surface. The first electrode may be entirely disposed on one of the at least two outer sides. The first electrode may be on the outer back surface immediately adjacent one of the at least two outer sides. The first electrode may extend over an edge between the outer back surface and one of the outer sides. The outer sides may each be rectangular, and the first electrode may be centered between two short sides of one of the outer sides and have a long axis extending in the direction of a long side of one of the outer sides. The first electrode may extend on or near the outer side surface for more than half the length of the outer side. The second and third electrodes may be symmetrically disposed relative to each other from the center of the outer back surface. The second and third electrodes may be part of an electrode unit that fits into an opening in the outer back surface of the case. The first electrode may have a surface area approximately the same as a surface area of ​​the second or third electrode.

[0080] The device may include only three electrodes on the outer surface of the case. The outer back surface of the case may include one or more spacers configured to extend a portion of the outer back surface relative to the outer contact surfaces of the first and second surfaces such that the outer contact surfaces are recessed relative to the outer surfaces of the one or more spacers.

[0081] The apparatus may further include an ultrasound transmitter configured to ultrasonically transmit signals sensed from the first, second, and third electrodes to a wireless telecommunications device.

[0082] Aspects of the present disclosure also provide an electrocardiogram (ECG) detection apparatus for use with a wireless telecommunications device. The apparatus may include a case configured to fit over the telecommunications device. The case may have an outer back surface, at least two outer sides perpendicular to the back surface, and a front area through which a screen of a telecommunications device held in the case can be viewed. The apparatus may further include a first electrode on or adjacent to one of the at least two outer sides, a second electrode on the outer back surface and having an outer contact surface, a third electrode on the outer back surface and having an outer contact surface, and an ultrasonic transmitter configured to wirelessly (e.g., ultrasonically) transmit signals sensed from the first, second, and third electrodes to the wireless telecommunications device. The outer contact surfaces of the second and third electrodes may be recessed relative to at least a portion of the outer back surface such that the outer contact surfaces of the second and third electrodes do not contact the table surface when the case is placed on a table surface with the outer back surface facing the table surface.

[0083] An embodiment of the present disclosure also provides a method of generating an electrocardiogram (ECG) from a patient using a handheld wireless telecommunications device case having three electrodes on an outer surface of the case. The patient may be instructed to hold a first electrode extending along the side of the case against a leg while simultaneously touching a second electrode on the back of the case with the right hand and a third electrode on the back of the case with the left hand so as not to touch more than three electrodes on the case. Between the third electrode and the second electrode, a first lead signal of the ECG (Lead I) may be detected. Between the second electrode and the first electrode, a second lead signal of the ECG (Lead II) may be detected. Between the first electrode and the third electrode, a third lead signal of the ECG (Lead III) may be detected.

[0084] Aspects of the present disclosure also provide a method of generating an electrocardiogram (ECG) from a patient using a handheld wireless telecommunications device case having three electrodes on an exterior surface of the case. The patient may be instructed to hold a first electrode of the case against a leg while simultaneously touching a second electrode with the right hand and a third electrode with the left hand so as not to touch more than three electrodes on the case. Between the third electrode and the second electrode, a first lead signal of the ECG (Lead I) may be detected. Between the second electrode and the first electrode, a second lead signal of the ECG (Lead II) may be detected. Between the first electrode and the third electrode, a third lead signal of the ECG (Lead III) may be detected. The lead signals may be transmitted wirelessly (e.g., by ultrasound) from the case to the telecommunications device.

[0085] Also described herein is a wearable wristlet device that can reliably and conveniently transmit recorded information (e.g., ECG information) from a user using ultrasound. Also described is a viewing station that includes control logic for configuring and operating a mobile computing / telecommunications device as a viewing station capable of securely and reliably receiving this ultrasound data.

[0086] In general, devices, systems, and methods are described herein for ultrasonically transmitting digital and / or analog data from (and possibly to) a wearable (e.g., wristlet) device having one or more sensors, a microprocessor, and a transducer capable of delivering ultrasonic frequencies (i.e., a piezoelectric speaker). The digitally transmitted data may be received by a receiving device having a microphone, such as a telecommunications device (e.g., a personal telecommunications device, a phone such as an iPhone®, DROID, or other smartphone, an iPad® or other personal computer, a PDA, etc.), which is capable of receiving audio in the ultrasonic frequency range (e.g., greater than 17 kHz, greater than 18 kHz, between about 16 kHz and about 22 kHz, between about 17 kHz and about 30 kHz, between about 18 kHz and 32 kHz, between about 17 kHz and 42 kHz, etc.). The transmitted digital information may be encoded and / or encrypted, as described in more detail below. In addition, the information may be compressed (data compressed) before encryption.

[0087] Both one-way (e.g., wristlet to device) and two-way communication are contemplated, including various methods for performing simple two-way communication between the wearable device and an observation station (e.g., smartphone).

[0088] Also described herein are ultrasound digital modems and digital modem protocols and logic for securely transmitting digital information by ultrasound from a wearable device, such as a wristlet, to a remote communication device configured as a receiver.

[0089] Described herein is a wristlet device including one or more sensors for sensing activity and / or health information about a wearer, including a microcontroller configured as an ultrasonic modem. In some variations, the microcontroller includes logic (e.g., hardware, software, firmware, or some combination thereof) that enables the device to drive ultrasonic transmission of data from a speaker (e.g., a piezoelectric speaker element). Methods of configuring or adapting the microcontroller to operate as an ultrasonic modem are also described. For example, in some variations, the microcontroller may be programmed to operate as an ultrasonic modem. The ultrasonic modem may be configured to format information to be transmitted as a hybrid digital and analog format. In some variations, the ultrasonic modem may be an ultrasonic modem component that encrypts information using an encryption key.

[0090] Also described herein is a receiver configured to receive ultrasound digital data acoustically transmitted by an ultrasound digital modem. In general, a remote communication device (e.g., a smartphone) may be configured to operate as a receiver for receiving ultrasound digital data. Thus, the remote communication device may include hardware, software, and / or firmware configured to receive, decode, interpret, display, analyze, store, and / or transmit data transmitted by ultrasound transmission from a digital ultrasound modem. In some variations, logic (e.g., client software and / or firmware, applications, etc.) may be executed on the remote communication device such that the remote communication device may operate as a receiver for digital ultrasound data. Thus, a device including executable logic for receiving and interpreting (e.g., decoding) data transmitted by a digital ultrasound modem, and executable logic for receiving and interpreting (e.g., decoding) data transmitted by a digital ultrasound modem executable logic is described herein.

[0091] Specific devices and systems configured to include a digital ultrasound modem are further described herein. Any of these devices may include a source of digital information (e.g., a device such as a medical sensor or device (e.g., a thermometer, a pulse oximeter, etc.), an audio transducer (e.g., a speaker capable of emitting an ultrasonic signal), and a controller (e.g., a microcontroller) configured to encode the digital information from the source of digital information as an ultrasonic signal to be transmitted by the audio transducer). In some variations, the audio transducer is configured to emit both audible (e.g., lower than ultrasonic) sounds (e.g., to buzz or beep within the hearing range of a normal person) as well as ultrasonic frequencies (e.g., greater than 17 kHz).

[0092] In one example, a Texas Instrument AFE4110 digital thermometer is described herein as being modified as described to encode and transmit body temperature data by ultrasound to a telecommunications device (e.g., a smartphone) located at a distance from the thermometer. The device's microcontroller (a Texas Instruments MSP430 type controller) is configured to include an ultrasonic modem for transmitting ultrasonic digital data by encoding (via a microprocessor) a data signal for transmission on a connected piezoelectric speaker. The speaker may be the same speaker built into the thermometer and may be used to audibly inform the user that the body temperature is stable (e.g., in the normal human hearing range). Thus, the thermometer can be modified to include a digital ultrasonic modem at very low cost by executing control logic in the microcontroller to process data from the thermometer and transmit the encoded signal on the piezoelectric speaker in the ultrasonic frequency range (e.g., >17 kHz). The thermometer may include a security key (e.g., a barcode, QR code, etc.) printed on the outside of the device that can be read by a receiving telecommunications device (e.g., a smartphone).

[0093] For example, in some variations, systems are described herein that include a medical sensing device and a device that uses ultrasound to digitally transmit biological parameters received by the medical sensing device to one or more telecommunication devices (e.g., smartphones) where further processing and / or transmission of the information can occur. Executable logic may also be referred to as an adapter for adapting the medical sensing device so that the medical sensing device can transmit biological parameter information ultrasonically to the telecommunication device for further processing. Systems and / or subsystems are also described for use with the telecommunication device so that the telecommunication device can receive and convert health metrics information signals encoded in ultrasound. These subsystems may include client software (e.g., applications) to be executed on the telecommunication device (e.g., phone) to convert ultrasound health information (or biological parameter) signals into digital signals that can be uploaded, stored, and / or analyzed by the telecommunication device.

[0094] A medical sensing device may be any device for receiving biological parameters, such as a patient's vitals. The biological parameters may also be referred to as biometric data. For example, a medical sensing device may be a thermometer, a blood pressure transducer, a glucose monitor, a pulse oximeter, a heart rate monitor, a pedometer, an activity monitor, a hydration monitor, and the like. The medical sensing devices or systems referred to herein are typically digital systems because they can display a numerical (e.g., digital) representation of the biological parameters. For example, the device may convert an analog biological parameter (e.g., body temperature, blood glucose, blood pressure, or any other health metric information) into a digital signal that can be displayed or otherwise presented to a user. For example, a medical sensing system may include a digital thermometer for taking a subject's temperature, a cuff for presenting the patient's blood pressure, a blood glucose (glucose) monitor, a pulse oximeter, and the like, including combinations of these devices. Of particular interest are home medical sensing systems or devices, especially those that have sensors that observe or collect biological parameters from a patient and present the information on a display.

[0095] As described in more detail below, in some variations, devices and systems format and / or encode information such that it includes a hybrid of both digital (e.g., abstracted and / or alphanumeric) and analog (e.g., graphical) information. As used herein, the term "analog" refers to information that can be sequenced and displayed graphically to show changes or trends. Analog information can refer to a variable physical level that is quantified (e.g., a variable that changes over time). Although the actual information may be digital (e.g., by converting from continuous to discrete values), it may still be referred to as "analog" herein because it represents a change in one or more parameters over time, distance, or some other variation.

[0096] Any of the information transmitted as an ultrasound signal (e.g., analog, digital, hybrid digital / analog, etc.) may be encrypted. For example, the information may be encrypted using an encryption key. The encryption key may be displayed on the device transmitting the ultrasound signal or otherwise made available on or by the device. Generally, the encryption key may be entered into a telecommunications device such that that particular device may then pair with a device that includes an ultrasound modem and receive and decrypt the information. Data encryption may allow for protection of patient sensitive information. Encryption may also reduce noise in the system since it may limit the signals received to those that are properly encoded.

[0097] As used herein, biological parameters or information may include any patient information, particularly digitally encoded biological parameters, that is processed, sensed, and / or calculated by a medical sensing system. For example, biological parameters may include body temperature, blood pressure, blood glucose level, pH, oxygen saturation, heart rate, respiratory rate, or any other biological measurement, particularly those relevant to cases including diagnosis and health monitoring.

[0098] As used herein, a remote communication device includes a smartphone (e.g., iPhone®, Droid®, or other personal communication device), a tablet computer (e.g., iPad®, tablet PC, etc.), and / or a desktop computer that includes (or may be adapted to include) a microphone capable of receiving ultrasonic sound. The remote communication device may include logic for converting digital signals encoded by the ultrasonic sound into digital signals that may be displayed, uploaded / transmitted, stored, and / or analyzed.

[0099] Thus, in some variations, a medical sensing device for transmitting a digital biological parameter by ultrasound is described herein. In some variations, the device may include a sensor for detecting the biological parameter from a patient, a processing device for encoding a digital representation of the biological parameter as an ultrasound audio signal, and an ultrasound transducer for transmitting the ultrasound audio signal from the processing device.

[0100] For example, the sensor may be a transducer (such as a temperature sensor, a pressure sensor, etc.) for converting a biological parameter. The device may also include a controller (e.g., a microcontroller) for processing a signal from the sensor. The processing device may include a signal generator that generates a signal from the sensed and / or processed patient biological parameter information, and the signal may be encoded for transmission. The signal may be encoded as a digital packet (e.g., a word, a byte, etc.). For example, the signal may include a start bit, a stop bit, information bits (e.g., a packet identifier) ​​that identify a type or source of the biological parameter, a digital representation of the biological parameter, and in some variations, a cyclic redundancy check (CRC) portion. In some variations, the signal (including the biometric measurement or data portion) may have a time stamp and / or a date stamp.

[0101] As mentioned, in some variations, the system may be configured to encrypt the information and transmit only the encrypted information. The remote communication device may be configured to receive the encryption key directly (e.g., by capturing and / or analyzing numbers that describe the encryption key).

[0102] In some variations, the system or device may be configured such that a measurement is taken at time x, stored on the device (e.g., thermometer, glucose meter, etc.), and later transmitted by ultrasound to a remote communication device (e.g., smartphone or tablet) and eventually uploaded (e.g., to the cloud). In some variations, several time-stamped / date-stamped measurements may be recorded on the device and transmitted together in bursts to the remote communication device. As explained in more detail below, the device may in some variations be primarily one-way (e.g., transmitting data from the biometric device to the remote communication device), and the device may be configured to receive at least a confirmation signal and / or indicator that it is in the vicinity of the remote communication device. In some variations, the ultrasound transducer may also be configured to receive a confirmation signal from the remote communication device. The confirmation may indicate that the remote communication device has received the transmitted message (data), or that the remote communication device is ready to receive the transmitted data, or both.

[0103] The ultrasonic transducer may be any suitable transducer, including a piezoelectric crystal transducer.

[0104] In some variations, a system for transmitting a digital biological parameter by ultrasound includes a medical sensing device having a sensor for detecting the biological parameter, a processing device for encoding a digital representation of the biological parameter as an ultrasound audio signal, and an ultrasound transducer for transmitting the ultrasound audio signal, and client control logic executed by the remote communication device and configured to receive the ultrasound audio signal and convert it back into a digital representation of the biological parameter.

[0105] The processing device may convert part or all of the digital biological parameter signal (which is typically a numerical value) into an ultrasound signal through the use of any suitable signal processing technique, including but not limited to frequency shift keying.

[0106] The client control logic may be referred to as software (although it may be software, hardware, firmware, etc.) or a client application. The client control logic may execute on the remote communication device. The client control logic may also include components for passing the digital representation of the biological parameter to other devices, e.g., for uploading it, e.g., to a website or server. In some variations, the client control logic may be configured to display or otherwise present information locally on the remote communication device.

[0107] Also described herein is a system for transmitting digital health parameters, the system comprising an ultrasound transducer capable of transmitting signals in an outdoor environment at frequencies greater than about 17 kHz (e.g., centered around 19 kHz or 20 kHz) and a signal generator configured to generate an ultrasound signal corresponding to a digital representation of the biological parameter, wherein an identifier is associated with at least one frequency greater than about 17 kHz (e.g., centered around 19 kHz or 20 kHz).

[0108] As an example, a digital thermometer for ultrasonically transmitting digital temperature information to a remote communication device for further processing and transmission is described herein. The digital thermometer may include a temperature sensor for detecting a patient's temperature, a signal generator for generating a signal corresponding to a digital representation of the patient's temperature, and an ultrasonic transducer for transmitting the digital representation of the patient's temperature as an ultrasonic signal having one or more frequencies higher than 19 kHz. The thermometer may include a cryptographic key on the outside of the thermometer that can be photographed and / or viewed by a user and / or a remote communication device configured to receive the ultrasonic signal.

[0109] In general, a digital ultrasonic modem device for securely transmitting digital data by ultrasonic waves is described herein. Such a device may include a microprocessor, an ultrasonic transducer, an encryption key located on the device, and ultrasonic transmission logic that configures the digital data for acoustic transmission by the ultrasonic transducer at a frequency of 17 kHz or greater, the ultrasonic transmission logic further configured to encrypt the digital data according to the encryption key.

[0110] Any suitable ultrasonic transducer may be used. For example, the ultrasonic transducer may be a piezoelectric speaker. As mentioned, the encryption key may be visibly inscribed on the device and may be configured as an alphanumeric code, symbols, etc. For example, the encryption key may be configured as a barcode, QR code, etc.

[0111] Any of the systems described herein may be configured as a system for secure ultrasonic transmission of data, and may include an ultrasonic communication device having an ultrasonic transducer, an encryption key located on the ultrasonic communication device, and ultrasonic transmission logic configuring digital data for acoustic transmission by the ultrasonic transducer at a frequency of 17 kHz or greater, the ultrasonic transmission logic further configured to encrypt the digital data in accordance with the encryption key, and decryption logic executable on a remote communication device, the remote communication device having a receiver for receiving ultrasonic signals from the ultrasonic communication device, and the decryption logic configured to receive the encryption key and apply the encryption key to decrypt the ultrasonic signals.

[0112] Generally, the encryption key may be visible on the ultrasonic communication device, the device's packaging, or the like.

[0113] In any of these variations described herein, the remote communications device may include an input for entering an encryption key, which may provide information to the decryption logic. For example, the input may be a camera for taking an image of the encryption key (e.g., a barcode, QR code, etc.) and determining the encryption key from the image. In some variations, the input comprises a manual input (e.g., a keypad, touch screen, etc.) for manually entering the encryption key.

[0114] Methods for securely transmitting information using ultrasound are also described herein. For example, in some variations, the method includes receiving an encryption key present on an exterior surface of an ultrasonic communication device, receiving an encrypted ultrasonic signal from the ultrasonic communication device, and decrypting the ultrasonic signal with the encryption key.

[0115] In some variations, receiving the encryption key comprises obtaining the encryption key from an exterior surface of the ultrasonic communication device. Decoding the ultrasonic signal may include decoding the ultrasonic signal at the remote communication device. As mentioned, receiving the encryption key may comprise photographing the encryption key using a camera of the remote communication device.

[0116] In general, any of the systems described herein may use hybrid digital and analog encoding. For example, a device for transmission of both digital and analog ultrasound data (hybrid digital and analog data) may include a microprocessor, an ultrasound transducer, and hybrid transmission logic configured to generate a signal comprising digital data that is added to the analog data for acoustic transmission by the ultrasound transducer at frequencies of 17 kHz or greater.

[0117] As mentioned above, information may be encoded using frequency shift keying (FSK). The FSK digital data may be added to analog data that is not encoded by FSK, but is frequency modulated to form a hybrid digital / analog signal.

[0118] In any of these variations, the device may include a sensor for detecting a biological parameter from the patient and / or a microprocessor configured to extract digital data from the analog data. In some variations, the digital data comprises calibration data for the analog data (e.g., minimum values, maximum values, variable intervals (e.g., time intervals), scales, etc.). The analog data may comprise any suitable signal typically measured from a device sensor, such as EEG, a subject's temperature over time, a subject's glucose level over time, a subject's blood pressure over time, a subject's oxygen level over time, or a subject's physical activity over time.

[0119] Also described herein is a method of transmitting a hybrid digital and analog signal using ultrasound. For example, the method may include generating an ultrasound signal comprising digital data encoded with frequency shift keying (FSK) added to an analog signal comprising a frequency modulated signal modulated at a frequency greater than 17 kHz, and acoustically transmitting the signal using an ultrasound transducer.

[0120] The method may also include detecting a biological parameter from the patient, the analog signal comprising the biological parameter. The method may also include extracting digital data from the analog signal. The analog signal may comprise an EEG, a subject's temperature over time, a subject's glucose level over time, a subject's blood pressure over time, a subject's oxygen level over time, or a subject's physical activity over time.

[0121] In some variations, the method also includes receiving an ultrasonic signal on a telecommunications device having an ultrasonic audio pickup.

[0122] In any of the variations described herein, the ultrasonic signal may be stored prior to transmission. Any of the variations described herein may be encoded with an error correction code. The method may also include a step of retransmitting the ultrasonic signal, where the signal may be retransmitted a fixed number of times, or the signal may be retransmitted continuously. In some variations, bidirectional communication may be used between the ultrasonic communication device and a remote communication device that includes executable logic for receiving and / or decoding the ultrasonic signal. Thus, in some variations, the remote communication device may be configured to return a signal to the ultrasonic communication device. The ultrasonic communication device may include a receiver or may be adapted to receive the signal at a transmitter (e.g., a piezoelectric element).

[0123] Also described herein is an ECG sensing wristlet configured to transmit ECG information to a mobile telecommunications device or devices.

[0124] For example, described herein is a wireless wearable wristlet device for obtaining electrocardiogram (ECG) signals from a subject wearing such a device and transmitting this information by ultrasound to a mobile telecommunications device. The wristlet device may include a wristlet body configured to fit on a wrist, two or more electrodes for detecting ECG signals from the subject, an ultrasound transducer, and a processing device coupled to the ultrasound transducer and configured to receive the ECG signals from the two or more electrodes and encode the signals to be transmitted as ultrasound signals for transmission by the ultrasound transducer at frequencies greater than about 17 kHz.

[0125] The wristlet body may be configured as a strap (e.g., any type of watch strap), band, bracelet, etc. In some variations, the wristlet includes a "front" region that may be worn on the subject's wrist in an upright position. The wristlet may include a pair of electrodes (or more than two electrodes). For example, in some variations, the wristlet includes an inner electrode that faces the wearer's wrist when the wristlet is worn, so that the inner electrode may reliably contact the wearer's skin when worn. A second electrode may be located on the front or side of the wristlet. This second electrode may be configured to allow the wearer to touch the wristlet with the opposite hand / arm. In some variations, a third electrode may be located on the wristlet. For example, the third electrode may be on the side of the wristlet and may be configured to allow the subject to touch the third electrode to another part of the body (e.g., chest, leg, etc.).

[0126] The processing device may be configured to encode a signal to be transmitted as an ultrasonic signal for transmission by an ultrasonic transducer at a frequency between about 17 kHz and about 30 kHz (or any of the other ranges defined herein, including greater than 16 kHz, greater than 17 kHz, greater than 18 kHz, etc.) In general, the processing device may be configured to encode a signal to be transmitted as a hybrid signal comprising digital information added to an analog signal.

[0127] The device may also be configured to receive signals, including ultrasonic signals (e.g., ultrasound signals), from the mobile telecommunications device. In some variations, the device further comprises an ultrasonic receiver configured to receive ultrasonic signals from the mobile telecommunications device. This may also create pairing of information between the devices (e.g., for synchronization, confirmation of transmission of information, etc.). Separate receiving ultrasonic transducers may be used, or the same ultrasonic transducer may be configured to both transmit and receive. For example, the ultrasonic transducer may be configured to transmit signals from the processing device as ultrasonic signals and receive ultrasonic signals (e.g., from the mobile telecommunications device).

[0128] In some variations, the devices described herein (wristlets) can be configured to operate at extremely low power. As mentioned above, the devices can include batteries having a voltage of less than 1.8V.

[0129] In general, the devices described herein may be configured to operate in real time. In particular, ECG information may be received and transmitted in real time. A mobile telecommunications device may display (and / or retransmit) in real time. For example, a processing device may be configured to transmit an encoded ECG signal in real time.

[0130] In general, any of the wristlet devices may be configured without a display or output, or with only an audible output (e.g., a beep, tone), or with only an LED (e.g., a simple indicator light). Instead, the device may rely on communication with a base station, such as a mobile telecommunications device, to display and possibly analyze the signal. For example, the device may include an indicator that shows when it is communicating with a mobile telecommunications device. Thus, a wristlet device that does not include a display for displaying ECG information may make the device smaller, lighter, and less expensive to manufacture and operate.

[0131] Additionally, in some variations, the device may be configured to store most of the data, e.g., ECG data, and transmit it when a receiver, such as a cell phone, is ready to receive it. Thus, any of these variations may add additional information, such as timestamps / datestamps, user-entered data, etc. Thus, in some variations, the device further comprises a memory coupled to the processing device and configured to store the encoded signal for later transmission.

[0132] In some variations, as discussed above, the processing device is configured to encode the signal to be transmitted as a digital signal.

[0133] In general, a device (eg, a processing device) may also be configured to determine when a mobile telecommunications device has received an encoded signal from the device.

[0134] The wristlet devices described herein may also be configured as watches, may include watch faces, and the like.

[0135] Also described herein is a wireless wearable wristlet device for detecting electrocardiogram (ECG) signals from a subject wearing the device and transmitting this information by ultrasound to a mobile telecommunications device, the wristlet device comprising: a wristlet body configured to fit on a wrist, two or more electrodes for detecting ECG signals from the subject, an ultrasound transducer, and a processing device coupled to the ultrasound transducer and configured to receive the ECG signals from the two or more electrodes and encode the signal to be transmitted as a hybrid ultrasound signal comprising digital information that is added to an analog representation of the ECG signal for transmission by the ultrasound transducer at frequencies greater than about 17 kHz.

[0136] As described herein, a hybrid ultrasound signal may be configured to encode digital information using frequency shift keying (FSK) and add the FSK digital signal to an analog signal that is not FSK encoded but is frequency modulated. For example, the processing device may be configured to extract digital information from an ECG signal. In some variations, the digital information comprises calibration data for the analog signal. The processing device may be configured to encode a signal to be transmitted as an ultrasound signal for transmission by an ultrasound transducer at any suitable ultrasound frequency (e.g., a frequency above the normal hearing range), such as those described herein, e.g., a frequency between about 17 kHz and about 30 kHz.

[0137] In any of these device variations, the device may be configured to both transmit and receive ultrasound signals. For example, the device may include an ultrasound receiver configured to receive ultrasound signals from a mobile telecommunications device. In some variations, the same transducer used to transmit ultrasound signals (e.g., ECG signals) may also be configured to receive ultrasound signals (e.g., ready to receive requests to transmit, confirmation of transmission, requests to retransmit, etc.). The ultrasound transducer may be configured to transmit signals from the processing device as ultrasound signals and to receive ultrasound signals from the mobile telecommunications device.

[0138] Also described herein is a wireless wearable wristlet device for detecting electrocardiogram (ECG) signals from a subject wearing the device and transmitting this information by ultrasound to a mobile telecommunications device, the wristlet device comprising a wristlet body configured to fit on a wrist, two or more electrodes for detecting ECG signals from the subject, an ultrasound transducer configured to transmit and receive ultrasound signals, and a processing device coupled to the ultrasound transducer and configured to receive the ECG signals from the two or more electrodes and encode the signals to be transmitted as ultrasound signals for transmission by the ultrasound transducer at frequencies greater than about 17 kHz, and further configured to receive the ultrasound signals from the mobile telecommunications device.

[0139] Aspects of the present disclosure also provide a wireless wearable wristlet device for detecting electrocardiogram (ECG) signals from a subject wearing the device and transmitting this information wirelessly (e.g., by ultrasound) to a mobile telecommunications device. The wristlet device may include a wristlet body configured to fit on a wrist, two or more electrodes for detecting ECG signals from the subject, a wireless (e.g., ultrasound) transducer, and a processing device. The processing device may be coupled to the wireless transducer and configured to receive the ECG signals from the two or more electrodes and encode the signals to be transmitted as wireless signals (e.g., ultrasound signals for transmission by an ultrasound transducer at frequencies greater than about 17 kHz).

[0140] The processing device may be configured to encode the signal to be transmitted as an ultrasonic signal for transmission by the ultrasonic transducer at a frequency between about 17 kHz and about 30 kHz. The processing device may be configured to encode the signal to be transmitted as a hybrid signal comprising digital information added to an analog signal. The device may further comprise an ultrasonic receiver configured to receive the ultrasonic signal from the mobile telecommunications device. The ultrasonic transducer may be configured to transmit the signal from the processing device as an ultrasonic signal and to receive the ultrasonic signal from the mobile telecommunications device.

[0141] The device may further comprise a battery having a voltage of less than 1.8. The processing device may be configured to transmit the encoded ECG signal in real time. The device may further comprise a memory coupled to the processing device and configured to store the encoded signal for later transmission. The processing device may be configured to encode the signal to be transmitted as a digital signal. The device may further comprise an indicator indicating when the device is in communication with the mobile telecommunications device. The processing device may be further configured to determine when the mobile telecommunications device has received the encoded signal from the device. The device may be configured as a clock.

[0142] Aspects of the present disclosure also provide a wireless wearable wristlet device for detecting electrocardiogram (ECG) signals from a subject wearing the device and transmitting this information wirelessly (e.g., ultrasonically) to a mobile telecommunications device. The wristlet device comprises a wristlet body configured to fit on a wrist, two or more electrodes for detecting ECG signals from the subject, a wireless (ultrasound) transducer, and a processing device. The processing device may be coupled to the wireless (e.g., ultrasound) transducer and configured to receive the ECG signals from the two or more electrodes and encode the signals to be transmitted as hybrid wireless (e.g., ultrasound) signals comprising digital information that is added to an analog representation of the ECG signal for transmission. The ultrasound transducer may transmit signals at frequencies greater than about 17 kHz.

[0143] The hybrid ultrasound signal may be configured to encode digital information using frequency shift keying (FSK) and add the FSK digital signal to an analog signal that is not encoded by FSK but is frequency modulated. The processing device may be configured to extract digital information from the ECG signal. The digital information may comprise calibration data for the analog signal. The processing device may be configured to encode a signal to be transmitted as an ultrasound signal for transmission by the ultrasound transducer at a frequency between about 17 kHz and about 30 kHz. The ultrasound receiver may be configured to receive an ultrasound signal from a mobile telecommunications device. The ultrasound transducer may be configured to transmit a signal from the processing device as an ultrasound signal and to receive an ultrasound signal from the mobile telecommunications device.

[0144] The device may further comprise a battery having a voltage less than 1.8V. The processing device may be configured to transmit the encoded signal in real time. The device may further comprise a memory coupled to the processing device and configured to store the encoded signal for later transmission. The processing device may be configured to encode the signal to be transmitted as a digital signal. The device may further comprise an indicator indicating when the device is in communication with the mobile telecommunications device. The processing device may be further configured to determine when the mobile telecommunications device has received the encoded signal from the device. The device may be configured as a clock.

[0145] Aspects of the present disclosure also provide a wireless wearable wristlet device for detecting electrocardiogram (ECG) signals from a subject wearing the device and transmitting this information wirelessly (e.g., by ultrasound) to a mobile telecommunications device. The wristlet device may include a wristlet body configured to fit on a wrist, two or more electrodes for detecting ECG signals from the subject, a wireless (e.g., ultrasound) transducer configured to transmit and receive ultrasound signals, and a processing device coupled to the wireless (e.g., ultrasound) transducer and configured to receive the ECG signals from the two or more electrodes and configured to encode the signals to be transmitted as wireless (e.g., ultrasound) signals for wireless (e.g., ultrasound) transmission. The ultrasound transducer may transmit signals at a frequency greater than about 17 kHz. The processing device may be configured to receive the ultrasound signals from the mobile telecommunications device.

[0146] The wearable computing device may also be in the form of a wristlet or armband. Aspects of the present disclosure also provide an external housing or cover for a computing device worn on the wrist or arm. The external housing or cover may include two or more electrodes for detecting ECG signals from a subject and a wireless transmitter for transmitting the ECG signals to the computing device worn on the wrist or arm.

[0147] FIG. 1 shows a schematic diagram of a system 1000 for measuring and observing one or more biometric or physiological parameters of a user US. The system 1000 may comprise a computing device 1100 and an external sensor device 1200 for coupling to or removably attached to the computing device 1100. The computing device 1100 may comprise one or more of a personal computer, a laptop computer, a tablet computer (such as Apple iPad®, Apple iPod®, Google Nexus tablet, Samsung Galaxy tablet, Microsoft Surface, etc.), a personal digital assistant (PDA), a smartphone (such as Apple iPhone®, Google Nexus phone, Samsung Galaxy smartphone, etc.), or a wearable computing device (such as Google Glass, Samsung Galaxy Gear Smart Watch, etc.). In many embodiments, the computing device comprises a tablet computer or a smartphone. The external sensor device 1200 may be configured to removably couple to the computing device 1100 and may comprise a cover for covering the computing device, such as a tablet computer case or a smartphone case or cover. In this manner, the user US may not need to replace the external sensor device 1200 when he or she replaces or upgrades his or her computing device 1100. That is, the user can use the same external sensor device 1200 for the various computing devices 1100 that the user may have.

[0148] The computing device 1100 may comprise a processing device 1110, a memory unit 1120 such as a RAM module, a data storage unit 1130 (e.g., a flash memory module, a hard drive, a ROM, etc.), a network interface 1140 configured to connect with a cellular data network (e.g., using GSM, GSM plus EDGE, CDMA, quadband, or other cellular protocols) or a WiFi (e.g., 802.11 protocol) network, such as a local interface 1150, an operating system 1160 that may be stored in the data storage unit 1130, loaded into the memory unit 1120, and implemented by the processing device 1110, a first application 1170 such as a first mobile software application ("mobile app") downloaded from an online application distribution platform, a second application 1180 such as a second mobile software application ("mobile app") downloaded from the online application distribution platform, and a user interface 1190. For example, the online application distribution platform may be the Apple App Store, Google Play, Windows Phone Store, BlackBerry App World, etc. The operating system 1160 may comprise instructions for operating the computing device 1100. The user interface 1190 may comprise a display 1195 for displaying one or more components of the operating system 1160, the first application 1170, or the second application 1180. For example, the display 1195 may be a touch screen display for operating and controlling the operating system 1160, the first application 1170, or the second application 1180. One or more of these elements may be combined or omitted.The computing device 1100 may further include other components, such as a motion detection component, one or more cameras, additional displays, a power supply, a fan, various I / O ports, and the like.

[0149] The external device 1200 may comprise a sensor 1210, a processing device 1220, and a local interface 1230. The sensor 1210 is configured to couple with a user US through a connection 1215, a physical contact, for example, to sense or detect one or more physiological parameters of the user US. In general, the one or more physiological parameters comprise cardiac parameters, such as the user's heart rate, heart rate variability, blood pressure, blood pressure variability, arrhythmia, oscilloscope cardiogram (SCG), SCG parameters, electrocardiogram (ECG), or ECG parameters. Other physiological parameters are also contemplated. For example, the sensor 1210 may comprise an activity sensor, a blood glucose sensor, a blood oxygen level sensor, a thermometer, a respiration sensor, a metabolic sensor, an odor detector, etc. The processing device 1220 may receive the detected physiological parameter and process it into a signal for the local interface 1230 to transmit to the local interface 1150 of the computing device 1100 through a connection 1235. The connection 1235 may comprise a wired connection, such as a USB connection, a Firewire connection, a Lightning connection, etc. Alternatively, or in combination, the connection 1235 may comprise a wireless connection, such as a WiFi connection, a Bluetooth connection, a low-power Bluetooth connection, an NFC (near field communication) connection, a near field ultrasonic communication connection, etc., as described, for example, in U.S. Patent Nos. 8,301,232 and 8,509,882.

[0150] The first application 1170 may be stored in the storage 1130 of the computing device 1100, loaded into the memory 1120 of the computing device 1100, and executed using the processing device 1110 and the operating system 1160. The processing device 1110 may be coupled to the local interface 1150 of the computing device 1100 to receive the detected physiological parameters under instructions from the first application 1170. Furthermore, the processing device 1110 may store the received physiological parameters in one or more of the memory 1120 or storage 1130 of the computing device under instructions from the first application 1170. The stored physiological parameters may be time-stamped and tagged with user identification information for later access and analysis. The processing device 1100 may also cause the physiological parameters to be displayed on the display 1195 of the user interface under instructions from the first application 1170. For example, the physiological parameters may be displayed in real time as they are measured. The first application 1170 may also comprise algorithms executed by the processing device 1100 to analyze the physiological data and may present an interpretation and analysis to the user US. For example, if an arrhythmia is detected, the processing device 1100 may, under instruction from the first application 1170, alert the user US or also to a remote healthcare provider such as a doctor, nurse, or hospital through the network interface 1140. Furthermore, the processing device may be configured, under instruction from the first application 1170, to automatically transmit the physiological data through the network interface 1140 to a remote computing device, a remote server, or a remote healthcare provider such as a doctor, nurse, or hospital.

[0151] In some embodiments, the processing device 1110, under instructions from the first application 1170 or other applications, may use the measured physiological parameters to identify or authenticate a user and perform actions based on the user's identity. For example, a user may be authenticated based on characteristics of the user's heartbeat. The time length of a particular portion of the user's heart rhythm, the relative size of peaks in the user's electrocardiogram (ECG), or other related amplitudes or amplitude ratios may be processed and compared to stored profiles to authenticate the user. The processing device 1100, under instructions from the first application 1170 or other applications, may be used to generate a baseline profile. In some embodiments, the processing device 1100, under instructions from the first application 1170 or other applications, may use the measured physiological parameters to determine the user's mood and provide related data.

[0152] For example, the electrical activity of the user's US heart may be detected and analyzed. A typical heartbeat may include several variations in electrical potentials that may be classified into waves and complexes, including P waves, QRS complexes, T waves, and possibly U waves, as known in the art. The shape and duration of the P waves may be related to the size of the user's atrium (e.g., indicative of atrial enlargement) and may be the first source of information on the user's specific heartbeat characteristics.

[0153] The QRS complex may correspond to the depolarization of the ventricles and can be divided into three separate waves: the Q wave, the R wave, and the S wave. Because the ventricles contain more muscle than the atria, the QRS complex is larger than the P wave. Also, the His / Purkinje system of the heart, which can increase the conduction velocity and coordinate the depolarization of the ventricles, may cause the QRS complex to appear "spiky" rather than rounded. The duration of the QRS complex in a healthy heart may range from 60 ms to 100 ms, but may vary due to conduction abnormalities. The duration of the QRS complex may serve as another source of information about the user's unique heartbeat characteristics.

[0154] The duration, amplitude, and morphology of each of the Q, R, and S waves may vary from person to person, and in particular may vary significantly in users with cardiac disease or abnormalities. For example, a Q wave that is greater than 1 / 3 the height of an R wave, or a Q wave that is greater than 40 ms in duration, may be indicative of a myocardial infarction and may provide a unique characteristic of the user's heart. Similarly, other healthy ratios of Q and R waves may be used to distinguish the heartbeats of different users.

[0155] The cardiac electrical activity of the user US may also include one or more characteristic time lengths or intervals that can be used to distinguish different users. For example, the cardiac electrical activity may include the PR interval and the ST segment as known in the art. The PR interval may be measured from the beginning of the P wave to the beginning of the QRS complex. The PR interval may typically last from 120 ms to 200 ms. PR intervals with different time lengths may indicate one or more cardiac defects of the heart, such as first degree atrial block (e.g., PR interval lasts longer than 200 ms), pre-excitation syndrome via accessory pathway leading to premature activation of the ventricles (e.g., PR interval lasts less than 120 ms), or another type of atrial block (e.g., variable PR interval). The ST segment may be measured from the QRS complex to the T wave, for example, starting at the intersection of the QRS complex and the ST segment and ending at the beginning of the T wave. The ST segment may typically last from 80 ms to 120 ms and is usually slightly convex downward. The combination of ST segment length and ST segment depression or elevation may also be used to generate characteristic information specific to each user's heart beat.

[0156] The T wave may represent the repolarization or recovery of the ventricles. The interval from the beginning of the QRS complex to the apex of the T wave may be referred to as the absolute refractory period. The last half of the T wave may be referred to as the relative refractory period or vulnerable period. The amplitude of the T wave, the duration of the absolute refractory period and the relative refractory period may also be used to define the characteristics of the user's heart rate.

[0157] A QT interval may be measured, which may represent the total time required for the ventricles to depolarize and repolarize, from the beginning of the QRS complex to the end of the T wave. The QT interval may typically last from 300 ms to 450 ms and may vary based on the user's heart rate condition. Several correction factors have been developed to correct the QT interval 222 of the heart rate. Both the measured and corrected QT interval values ​​may be used to define the unique characteristics of the user's heart rate.

[0158] Because the heartbeat or heart rate of the user US may vary slightly based on the activity or mood of the user US, each authorized user US may initially provide a baseline or standard heart rate, heart beat, or electrical activity to the device before first use. The first application 1170 may be executed by the processing device 1110 to record this baseline measurement. For example, the external device or sensor 1200 may sample several heart beats or electrical activity at several different times to detect variations in the cardiac electrical activity of the user US. This data may be transmitted to the computing device 1100. The processing device 1110 may then process the detected signals under instructions from the first application 1170 to determine several unique characteristics of the cardiac activity of the user US and identify appropriate ranges of characteristic values ​​for each of the processed characteristics. Based on the characteristic values ​​and associated ranges, the processing device 1110 may select one, all, or a subset of the characteristics to define a unique cardiac activity profile of the authorized user US. The particular combination of characteristics and associated ranges may be selected to minimize overlap with other authorized users, or may be based on characteristic values ​​and ranges that are not within certain average values ​​and average ranges (e.g., without using characteristic values ​​and ranges that an average user of the device would have).

[0159] The system 1000 may be used to authenticate a user US based on the measured electrical activity of the user US's heart when compared to the generated profile. If the measured electrical activity matches the generated profile, the processing device 1110 may authenticate the user US under instructions from the operating system 1160, the first application 1170, or other applications. The processing device 1110 may also be instructed to perform any appropriate action in response to identifying and authenticating the user US. In some embodiments, the processing device 1110 may be instructed to provide access to restricted applications, e.g., applications that only a particular user has a license for, or applications that only a particular user has purchased. In some embodiments, the processing device 1110 may be instructed to provide access to certain data or application settings associated with an approved user US. For example, the processing device 1110 may be instructed to provide access to the identified user US's contact list, or the identified user US's email account, or call history. As another example, the processing device 1110 may be instructed to enable the user US to access a private banking application or to use the electronic device to perform a financial transaction (e.g., transfer funds to a different account or purchase an item). In some embodiments, the computing device 1100 may load settings and profiles of the user US to provide a customized display to the user. For example, the computing device 1100 may display icons or options in a manner set by the user, or may display using color schemes, fonts, or other customizable display attributes associated with an identified user.

[0160] In some embodiments, the system 1000 can use the detected heart rate or heart rate characteristics to determine the mood of the user US. Specifically, since the acceptable determined characteristics associated with each user US may include a range of values, the processing device 1110 can be instructed to determine a distribution of the detected characteristics in the acceptable characteristic range. Using the determined distribution, the processing device 1110 can establish the user's mood and provide an action or data (e.g., media) to the electronic device that is associated with the estimated mood.

[0161] In some embodiments, the computing device 1100 can perform media playback based on the detected mood or cardiac signal of the user US. For example, the computing device 1100 can identify media having a beats per minute or other characteristic that is associated with or related to the cardiac signal or heart rate of the user US, and play the identified media. As another example, the provided media may have a beats per minute rate that is faster or slower than the user's current heart rate to prompt the user to work harder (e.g., during exercise) or to instruct the user to cool down or take it easy (e.g., at the end of a workout).

[0162] Aspects of the present disclosure may also include a process for performing computing device operations based on a cardiac signal of a user US. In a first step, the system 1000 may detect a cardiac signal of a user US. For example, a heart rate or heartbeat of the user US may be detected using the sensor 1210 of the external device 1200. The external device 1200 may transmit the detected signal to the computing device 1100 through the connection 1235. The computing device 1100 may process the received signal using any suitable technique, including determining an inherent characteristic of the signal. Such characteristics may include, for example, a time length between peaks of the EKG signal, a peak value or a peak-to-peak ratio of the EKG signal, or any other suitable characteristic as described herein. In a further step, the computing device 1100 may determine whether the previously detected user US is an authorized user. For example, the computing device 1100 may compare the determined characteristic of the detected cardiac signal with a library of signals associated with known authorized users. If the computing device 1100 determines that the user US is unauthorized (e.g., the detected cardiac signal characteristics do not match the cardiac signal characteristics stored in memory), the computing device 1100 can prevent access to restricted electronic device operations in a further step. For example, the computing device 1100 can prevent the user from accessing personal or private information associated with other users. As another example, the computing device 1100 can prevent the user US from accessing applications or operations associated with a particular user (e.g., applications purchased by a particular user). As yet another example, the computing device 1100 can prevent the user US from accessing all electronic device operations (e.g., operations other than emergency calling).

[0163] Alternatively, if the computing device determines that the user US is authorized, the process may proceed to a fourth step, where the computing device 1100 determines the restricted operations associated with the user US. For example, the computing device 1100 may determine certain private data associated with the authorized user (e.g., email accounts, contact lists, and banking information). As another example, the computing device 1100 may determine certain operations or applications associated with the authorized user US (e.g., applications purchased by the user US using an application store, or system control operations associated with an administrator account). In a fifth step, the computing device 1100 may provide access to the determined restricted operations of the user US. For example, the computing device 1100 may load the determined data. As another example, the computing device 1100 may provide a link to launch the determined personal or private application.

[0164] The first application 1170 may also run in the background of the operating system 1160 and perform one or more of receiving, storing, and analyzing physiological data while the second application 1180 is in front of the display 1195 and is being actively operated by the user US. For example, the second application 1180 may comprise an email application, a web browser, a music player, or a game that is operated by the user US while the first application 1170 and the external sensor device 1200 are measuring the user's physiological parameters in the background.

[0165] The external sensor device 1200 may have many form factors, depending, for example, on the form of the computing device 1100 and the convenience of the user US.

[0166] 2A-2K show a biometric or physiological parameter measurement and observation system 2000 including a smartphone 2100 and a smartphone protective case 2200. FIG. 2A shows a perspective view of the system 2200 in which the smartphone 2100 and the smartphone protective case 2200 are separated. The protective case 2200 has a recess 2200C for receiving the smartphone 2100. FIG. 2B and FIG. 2C show rear views of the system 2000. FIG. 2D shows a perspective view of the system 2000 in which the smartphone 2100 and the smartphone protective case 2200 are coupled or removably attached to each other. The smartphone 2100 may include, for example, an Apple iPhone, a Google Android smartphone, a Google Nexus, a Samsung Galaxy phone, an HTC smartphone, a Nokia Windows smartphone, a Blackberry smartphone, and the like.

[0167] The smartphone 2100 may include a front surface 2110, an edge 2120, a back surface 2130, and a display 2140 on the front surface 2110. The smartphone protective case 2200 may include a plurality of electrodes for detecting physiological parameters such as an electrocardiogram (ECG). The plurality of electrodes may include a first electrode 2210 and a second electrode 2220. The smartphone 2100 and the protective case 2200 are joined together, and at least some of the plurality of electrodes are disposed over the edge 2120 of the smartphone 2100. In this manner, the thin and narrow profile of the smartphone 2100 can be maintained, for example, for the convenience of the user. As shown in FIG. 2B, the first electrode 2210 and the second electrode 2220 may be disposed opposite each other on the upper and lower edges (i.e., short sides) of the protective case 2200, respectively. As shown in FIG. 2C, the first electrode 2210 and the second electrode 2200 may be disposed opposite each other on the left and right edges (i.e., long sides) of the protective case 2200, respectively. FIGS. 2B and 2C show the back side 2200B of the protective case 2200. The electrodes are generally electrically insulated from each other to prevent shorting or interference. The electrodes also generally protrude slightly from the body of the protective case 2200. For example, the electrodes may be polished, roughened, or otherwise finished to match the exterior surface of the protective case 2200.

[0168] The sensor electrodes described herein may be constructed from any suitable material. The electrodes may be constructed from a particular material selected for particular conductive properties that enable more effective transmission of electrical signals reflecting the activity of the user's heart, for example. The electrodes may be constructed from a silver-based compound, which can provide superior electrical conductivity compared to other metal compounds (e.g., steel or aluminum). The size and location of the electrodes may also be selected to ensure that sufficient contact occurs between the user (e.g., the user's hand or finger) and the electrode. For example, each electrode may include a pad or extended area that is disposed on the outer surface of the body of the external sensor device 1200.

[0169] In use, a user may hold the system 200 in his / her hand and touch the first electrode 2210 on the user's right arm RA and the second electrode 2220 on the user's left arm LA to measure one or more physiological parameters, such as heart rate or ECG, as shown in FIG. 2E and FIG. 2F. As shown in FIG. 2E, a first application 1170 may be active on the system 2000 and displaying measured parameters in real time. As shown in FIG. 2F, a second application 1180, e.g., an email application, may be active on the system 2000 and operated by the user US while the first application 1170 receives physiological parameter data in the background. By touching multiple electrodes on the right arm RA and left arm LA, a lead I ECG may be measured. The user US may also touch the first electrode 2210 on the right arm RA and left leg LL to measure a lead II ECG. The user US may also touch the first electrode 2210 on the right arm RA and left leg LL to measure a lead III ECG.

[0170] Other arrangements of the electrodes are also contemplated. As shown in FIG. 2G, the first electrode 2210 and the second electrode 2220 may be disposed at corners of the protective case 2200. Additionally, the electrodes may include a third electrode 2230. As shown in FIG. 2H, the first electrode 2210 and the second electrode 2220 may be disposed at top and bottom edges (i.e., short sides) of the protective case 2200, while the third electrode 2230 may be at a side edge or long side of the protective case 2220. As shown in FIG. 2I, the first electrode 2210 and the second electrode 2220 may be disposed at opposite corners of the protective case 2220, while the third electrode 2230 may be at a side edge or long side of the protective case 2200. 2J, the first electrode 2210 and the second electrode 2220 may be disposed on the left and right edges (i.e., long sides), while the third electrode 2230 may be on a lateral edge or long side of the protective case 2200. In some embodiments, the first electrode 2210 and the second electrode 2220 may be disposed on the edges of the protective case 2200, and the third electrode 2230 may be disposed on the back surface 2200B of the protective case 2200.

[0171] In use, a user may hold the system 2000 in hand and touch the first electrode 2210 on the user's right arm RA, the second electrode 2220 on the user's left arm, and the third electrode 2230 on the user's left leg LL to measure one or more physiological parameters, such as heart rate or ECG, as shown in FIG. 2K. As shown in FIG. 2K, a second application 1180, e.g., an email application, may be active on the system 2000 and may be operated by the user US while the first application 1170 receives physiological parameter data in the background. By touching multiple electrodes on the right arm RA, left arm LA, and left leg LL, a lead I ECG, a lead II ECG, and a lead III ECG may be measured. A lead I ECG, a lead II ECG, and a lead III ECG may also be measured simultaneously. Three-electrode wireless ECG devices are further described in commonly owned U.S. Provisional Patent Application No. 61 / 845,254, filed July 11, 2013, entitled "Three-Electrode Wireless ECG Apparatus," the contents of which are incorporated herein by reference.

[0172] 3A-3F show a biometric or physiological parameter measurement and monitoring system 3300 comprising a tablet computer 3100 and a tablet computer protective case 3200. System 3000 may be similar in many respects to system 2000. System 2000 is adapted for use with a smartphone 2100, while system 3000 is adapted for use with a tablet computer 3100. Tablet computer 3100 may comprise an Apple iPad®, a Google Nexus tablet computer, a Samsung Galaxy tablet computer, a Microsoft Surface tablet computer, or the like.

[0173] Figure 3A shows a perspective view of system 3000 in which protective case 3200 has a recess 3200C for receiving tablet computer 3100. Tablet computer 3100 has a front surface 3110, a rim 3120, a back surface 3130, and a display 3140. Figure 3B shows tablet computer 3100 coupled or removably attached to protective case 3200.

[0174] FIG. 3B also shows that the tablet computer protective case 3200 may include a plurality of sensor electrodes, including a first electrode 3210 and a second electrode 3220. As shown in FIG. 3B and FIG. 3C, the first electrode 3210 and the second electrode 3220 may be disposed facing each other over the edge 3120 of the tablet computer 3100. Other alternative arrangements are also contemplated. For example, FIG. 3D shows the first electrode 3210 and the second electrode 3220 disposed on the back surface 3130 of the protective case 3200. Also, the plurality of electrodes may further include a third electrode 3230 disposed on the back surface 3130 of the protective case 3200 as shown by FIG. 3E.

[0175] The system 3000 may be used in a manner similar to the system 2000 described above to measure physiological signals. For example, multiple electrodes of the system 3000 may be in contact with a user US to measure one or more of a lead I ECG, a lead II ECG, or a lead III ECG. As shown in FIG. 3F, the user US may operate the system 3000 and the tablet computer 3100 normally while the first electrode 3210 is in contact with the user's right arm RA, the second electrode 3220 is in contact with the user's left arm LA, and the third electrode 3230 (not shown) is in contact with the user's left leg. Although FIG. 3F shows that the first application 1170 for managing the detected physiological parameters is active on the tablet computer 3100, it is contemplated that instead the second application 1180 is active and operated by the user US while the first application 1170 and the protective case 3200 sense and detect physiological parameters.

[0176] Other computing device accessories are also contemplated for simultaneously measuring various physiological parameters of the user US while the computing device is in normal use.

[0177] 4A-4C show a biometric or physiological parameter measurement and monitoring system 4000 comprising a keyboard 4100 of a computing device 1100 and a keyboard accessory 4200, which may comprise a keyboard wrist rest. The keyboard 4100 may be removably coupled to the keyboard accessory 4200 (compare FIG. 4A and FIG. 4B). The keyboard accessory 4200 comprises a physiological parameter sensor, such as a plurality of electrodes, such as a first electrode 4210 and a second electrode 4220. As shown in FIG. 4C, the first electrode 4210 may be in contact with the user's right arm RA and the second electrode 4220 may be in contact with the user's left arm LA to detect a lead I ECG while the user US normally operates the computing device 1100 through the keyboard 4100.

[0178] 5A-5C show a biometric or physiological parameter measurement and monitoring system 5000 comprising a laptop or palmtop computer 5100 and a sensor accessory 5200. The computer 5100 may be removably coupled to the sensor accessory 5100 (compare FIG. 5A to FIG. 5B). The sensor accessory 5200 comprises a physiological parameter sensor, such as a plurality of electrodes, such as a first electrode 5210 and a second electrode 5220. As shown in FIG. 5C, the first electrode 5210 may be in contact with the user's right arm RA and the second electrode 5220 may be in contact with the user's left arm LA to detect a Lead I ECG while the user US is normally operating the computer 5100.

[0179] Additional sensor accessories for coupling with daily use devices are also contemplated. For example, embodiments of the present disclosure may provide sensor accessories for handlebars, seats, chairs, glasses, clothing, etc. of exercise machines such as bicycles, bikes, treadmills or elliptical machines or weightlifting machines. As another example, the sensor systems described herein may be in the form of watches, wristlets, wristbands, or accessories for such devices. ECG sensing watches and wristlets are described in commonly owned U.S. Provisional Patent Application No. 61 / 872,555, entitled "Ultrasonic Transmission of Signals from an ECG Sensing Wristlet," filed August 30, 2013. The sensor accessory may detect and measure one or more physiological parameters and communicate the measurements to a computing device associated with the daily use device or to another computing device.

[0180] FIG. 6 shows a method 6000 for biometric or physiological parameter measurement and observation. In step 6050, a computing device such as the computing device 1100 described herein may be provided. In step 6100, an external device or a shell of a computing device such as the external device 1200 described herein may be provided. In step 6150, the external device or shell may be coupled to the computing device. See, for example, the system 2000 described herein (FIGS. 2A-2D), the system 3000 described herein (FIGS. 3A-3B), the system 4000 described herein (FIGS. 4A-4C), and the system 5000 described herein (FIGS. 5A-5C). In step 6200, a physiological signal or parameter measurement and observation application may be downloaded to the computing device. The application may comprise the first application 1170 described above or may be downloaded from an application distribution platform over the internet as described herein. In step 6250, the application may be executed on the computing device. In step 6300, an external device or shell coupled to the computing device may contact a user to measure a physiological parameter. In step 6350, a physiological signal or parameter may be measured. In step 6400, the physiological signal or parameter may be stored, displayed, or otherwise processed. In step 6450, a physiological signal or parameter measurement and observation application may be placed in the background of the computing device. In step 6500, a second application may be executed on the computing device while the physiological signal or parameter measurement and observation application is performing operations in the background.

[0181] The above steps illustrate the method 6000 of biometric or physiological parameter measurement and observation, although one of ordinary skill in the art will recognize many variations based on the teachings described herein. Steps may be completed in different orders. Steps may be added or omitted. Some of the steps may comprise sub-steps. Many of the steps may be repeated as often as is beneficial.

[0182] One or more of the steps of method 6000 may be performed in conjunction with circuitry as described herein, such as a processing device or logic circuitry of a computing device, or one or more of their accessories. The processing device or logic circuitry may be programmed to provide one or more of the steps of method 6000, and the program may comprise program instructions stored in a computer-readable memory or programmed steps of the logic circuitry.

[0183] Generally, devices and methods for generating an electrocardiogram (ECG) from a patient are described herein, including a handheld wireless telecommunications device case having three electrodes on the outer surface of the case, and methods of using the same. These devices and methods may allow a user to take up to six leads (e.g., Lead I, Lead II, Lead III, aVR, aVL, and aVF) using a single handheld device, which are easily held by the patient against the patient's leg while simultaneously observing the device's display. Specifically, the device may be used in conjunction with a mobile telecommunications device (e.g., a smartphone). In another embodiment, the device may operate as a standalone device, with appropriate circuitry to function independently or in communication with a separate telecommunications device.

[0184] In general, the apparatus (including devices and systems) described herein may include three electrodes and are configured for use with a wireless telecommunications device. The wireless telecommunications device may be any suitable telecommunications device, including a smartphone (e.g., iPhone®, Android™, etc.), a tablet (e.g., iPad®, etc.), a laptop, a PDA, etc. The apparatus may be configured as a case and / or attachment to a mobile telecommunications device. The apparatus may wirelessly communicate information to the mobile telecommunications device. In some variations, the systems described herein transmit information to a mobile telecommunications device configured to receive and analyze information from the apparatus (e.g., by operating a program, application ("app"), etc.).

[0185] Thus, in general, the devices described herein may include a housing configured as a case or otherwise. The housing generally includes an outer surface on which the three (or possibly more) electrodes are arranged. In a variation in which the housing is configured as a case for holding a mobile telecommunications device, the case may have an outer back surface, at least two outer sides perpendicular to the back surface, and a front area through which the screen of the telecommunications device held in the case can be viewed.

[0186] For example, Figures 9A-9D show one variation of a housing configured as a case for a smartphone. In this example, case 300 is shown with a mobile telecommunications device (smartphone) 301 housed within the case. Case 300 includes a back (shown in Figure 9C) and a side (shown in Figures 9B and 9D). The front of case 300 in this example has an opening 301 through which the front of the smartphone (including the screen) can be seen and / or touched. The case may also include an opening on the side (e.g., 9B) for the phone's operating means.

[0187] Typically, the housing also includes at least (and in some variations exactly) three electrodes, one each for contacting the subject's right hand, left hand, and leg. For example, the first electrode may be configured to be held against the patient's leg. The second and third electrodes may also be configured and arranged on the housing such that the patient can touch the second electrode with his / her right hand and the third electrode with his / her left hand while holding the first electrode against his / her leg. The arrangement, shape, and / or size of the electrodes may be configured such that when measuring an ECG, the patient's hand does not contact more than one electrode, and the patient's leg also does not contact more than one electrode of the housing. For example, the first electrode may be located on the side or on the side edge (the back side edge) or both of the housing, while the second and third electrodes are located on the back, with all electrodes spaced far enough apart from each other to avoid the leg or hand contacting more than one electrode. Thus, the left hand can contact a single electrode, the right hand can contact another electrode, and the leg can contact the first (leg) electrode, all on the same housing.

[0188] 9A, the electrodes are arranged so that the first electrode 309 is on one of the outer sides of the case. Placing the first electrode on the side of the case may allow the first electrode to be easily held against the subject's leg while the patient is holding the case, such that the patient's first hand (e.g., left hand) contacts the second electrode and the other hand (e.g., right hand) contacts the second electrode.

[0189] In general, in any of the devices described herein, the electrodes may be on the outer surface of the housing. In some variations, the housing may be configured (or may include additional elements) to protect one or more electrodes from touching a surface, such as a table, when the device is placed on the surface. When the device is placed on a conductive surface (e.g., a metal table), the housing or additional features may prevent the outer surface of the electrodes from touching the surface. For example, the electrodes on the outer surface of the housing may be recessed relative to at least a portion of the outer back surface such that the outer contact surfaces of the first, second, and / or third electrodes do not contact the table surface when the case is placed on the table surface with the outer back surface facing the table surface.

[0190] As mentioned previously, placing the first electrode on the side may make it possible to use the device to take measurements from the leg while looking at the surface (e.g., a screen) of a remote communication device within the case.

[0191] In Figures 9A-9D, the case includes only three electrodes 309, 311, and 313, with the first (leg) electrode located on the outer side of the housing. The lateral (first) electrode is configured to extend along most of the lateral length of the housing. The second electrode 311 and the third electrode 313 are located closer to the center of the outer back surface of the housing. As is evident in the side views of Figures 9B and 9D, the housing protects the second and third electrodes because the height of the electrodes is lower than the remaining outer surface of the case.

[0192] Figures 10A-10D show another variation of the case having three electrodes. However, in this example, the first (leg) electrode 413 does not have an outer surface lower than the outer surface of the case, instead, as shown in Figure 10D, a third electrode protrudes from the outer surface. The case shown is otherwise similar to the variation shown in Figures 9A-9D, but these figures are shown without a mobile telecommunications device (e.g., a smartphone) within the case.

[0193] In some variations, as shown in Figures 11A-11C, a leg electrode (electrode 1) 509 extends laterally onto the back where the other electrodes 511, 513 are located.

[0194] Alternatively, in some variations, the leg electrodes are placed near an edge of the case (e.g., near a side edge), as shown in FIG. 12C. In general, the leg electrodes may be adjacent to one of the sides. The electrodes may be immediately adjacent to the side or may be in contact with the edge. FIGS. 12A-12C show a case configured such that the first electrode 613 is adjacent to a side of the case, and such that the second electrode 609 and the third electrode 611 may be offset from the first electrode and from the leg electrodes (or other electrodes) to prevent inadvertent contact by the subject's hand.

[0195] 7A-7C show another variation of the case with a first electrode 709 that extends from the back side through the side edge to the side as shown. In this example, the second and third electrodes are recessed into the outer surface of the back of the case, while the first electrode extends from the outer surface. This may make it easier to contact the legs and hold the case at an angle.

[0196] In some variations, the housing may be configured to hold an electrode unit that fits into an opening on the outer back of the case, the electrode unit including the second and third (and possibly the first) electrodes, and may also include circuitry for controlling / receiving ECG recordings. For example, Figures 14A-14C show a device configured as a case that holds an electrode unit 805, including second and third electrodes 811 and 813 to be touched by the patient's right and left hands, and a separate first electrode 809 on the side of the case. The electrode unit may protrude from the case and may include an outer (non-electrode) surface that extends further from the outer surface of the case than the second and third electrodes, preventing the second and third electrodes from touching the table surface when the device is placed on a table.

[0197] 15A-15C show another variation of the three-electrode housing in which all three electrodes (first electrode 909, second electrode 911, and third electrode 913) are lined up on the back of the case, as shown in FIG.

[0198] While many of the variations described herein have all three electrodes integrated into the outer surface of the case, in some variations one or more of the electrodes may be configured to extend from the surface of the case. For example, in Figs. 16A and 16B an example of a device is shown having a first electrode 1009 that may extend from the housing on a wire. When not in use, the wire may be stored in the case and the electrode 1009 may be coupled to the case, and when in use, the electrode may be pulled out of the case and may contact the patient's leg so that the case and smartphone can be held and viewed by the patient. In any of these variations, the smartphone may provide visual feedback to the patient before or during recording, for example indicating that good electrical contact is being made and / or showing the ECG trajectory taken by the system.

[0199] For example, FIG. 17 shows a method of operating the device 400 with electrodes on both hands (right hand, left hand) and on the legs. In this example, the subject SU sits on a chair CH and holds the device 400 configured as a smartphone case that holds a smartphone with both hands, so that each hand touches only one electrode on the back of the case. The case is held against the subject's legs such that the leg electrodes are pressed against the legs. The case and smartphone may then be used to record lead I, lead II, and lead III, from which at least three additional leads may be determined as discussed above. Specifically, augmented leads aVR, aVL, and aVF may be determined.

[0200] As described herein, a 12-lead ECG may be generated (e.g., by any of the devices described herein) using three electrodes. For example, in one embodiment, a device with three electrodes as described herein may be used to determine Lead I (e.g., the voltage between the left arm and the right arm) simultaneously with Lead II (e.g., the voltage between the left leg and the right arm) and Lead I simultaneously with Lead V2. In other embodiments, any other combination of leads is possible. Processing logic may then time align the two sets of recordings so that the two sets of measurements can be compared over the same simulated time period.

[0201] The processing logic may further transform the two sets of leads to generate a complete 12-lead ECG. In one embodiment, the processing logic may perform such transformation using a machine learning model (e.g., neural networks, deep learning techniques, etc.). The machine learning model may be trained using 12-lead ECG data corresponding to a population of individuals. The data may be pre-processed to filter the data in a manner appropriate for the application before being input to the machine learning model. For example, the data may be classified according to height, sex, weight, nationality, etc. before being used to train one or more machine learning models, such that the resulting model or models are fine-tuned for a particular type of individual. In a further embodiment, the machine learning model may be further trained based on a user's unique ECG data to even further fine-tune the model.

[0202] In one embodiment, using the machine learning techniques described herein, a complete 12-lead ECG can be generated using only three electrodes of a single device. As described herein, the three electrodes can be positioned on the device in any suitable manner, including two on the front and one on the back of the device.

[0203] Also described herein in general are devices and systems for ultrasonically transmitting information (e.g., biological parameter information) from a wearable (e.g., wristlet) sensing device by an ultrasonic transmission device to a remote communication device that can then process and / or transmit the biological parameter information. Specifically, the biological parameters may include an ECG signal. Wearable devices typically include an ultrasonic transducer, which may be part of an ultrasonic modem module / subsystem for encoding and transmitting information as acoustic ultrasonic signals. In many of the variations described herein, these devices are configured as a wristlet worn by the subject.

[0204] As described in more detail below, in some variations, the ultrasound signal (e.g., encoding the ECG) may be securely transmitted using an encryption key. Also described herein are systems, methods, and devices for easily pairing an ultrasound transmitting device to a remote communication device using an encryption key. For example, in some variations, the remote communication device may read (e.g., take an image of) an encryption key displayed on the ultrasound transmitting device. This technique may be readily performed by taking an image with the remote communication device of a mark (e.g., a barcode, a QR code, etc.) that includes the encryption key and determining the encryption key based on the image. Executable logic (e.g., decryption logic) executing on the remote communication device may be configured to interpret and apply this encryption key.

[0205] For example, a system capable of transmitting digital biological parameter information by ultrasound may include a sensor for sensing the biological parameter (e.g., vital signs), a processing device for constructing a representation of the biological parameter as a "digital" ultrasound signal, an analog signal, or a hybrid digital / analog signal, and a transducer for converting the ultrasound signal so that it can be transmitted in open space to a telecommunications-enabled device. The processing device may be part of, controlled by, or in communication with a controller (e.g., a microcontroller). The telecommunications-enabled device (telecommunications device) may include a receiver capable of receiving audio signals in the ultrasound range (audio receiver) and a processing device for converting the ultrasound signal back into an electronic signal for further processing or transmission.

[0206] Although the human hearing range is often stated to be 20 Hz to 20 kHz, under ideal laboratory conditions, a child's maximum hearing range actually extends to around 12 Hz and rarely remains at around 20 kHz. Furthermore, as shown in Figure 18, the threshold frequency, i.e., the lowest detectable intensity, rises rapidly to the pain threshold between 10 kHz and 20 kHz. Thus, sounds above about 16 kHz must be of considerable intensity to be heard. Almost immediately after birth, the threshold sound levels for these higher frequencies rise. As shown in Figure 19, the average 20-year-old has lost about 10 dB in the 8 kHz range, and at age 90, the average person has lost over 100 dB in this frequency range.

[0207] An exemplary product that uses very high frequency sounds is the Mosquito Alarm, a controversial device that is used to intentionally emit an annoying 17.4 kHz alarm to keep young people from wandering around. Due to adults' hearing loss at this frequency, this sound is usually only audible to people under the age of 25. Similarly, students exploit the hearing loss of adults by using a 15-17 kHz "mosquito" cell phone ringtone at school. The students hear the "mosquito" ringtone, but the adult teachers do not. The term "ultrasonic" usually means beyond the range perceived by humans. However, as indicated, the upper limit of audible frequencies generally varies by individual and age. Due to this difference in upper limit, the term "ultrasonic" as defined in this specification and the appended claims may refer to sound frequencies above 16 kHz (e.g., above about 17 kHz, above 18 kHz, etc.).

[0208] Interestingly, however, there is very little environmental sound or noise above about 10 kHz. Referring to Figure 20, most everyday sounds occur at frequencies below about 4 kHz. Thus, the use of signals in the ultrasonic range is not only quiet for bystanders, but also provides a very desirable signal-to-noise ratio (SNR).

[0209] Sound engineers may safely assume that frequencies above about 20 kHz have no effect on the perceived sound, and filter out all sounds above this range. Sounds below 20 kHz but in the ultrasonic range are of little concern, and standard sampling procedures have been established accordingly. It is generally understood that sampling an analog signal, whether it be a radio signal or an audible voice signal, requires a sampling frequency fs such that fs / 2>f, where f is the frequency of the sine wave. For this reason, sound systems are designed to sample sound at the now-standard sample rate of 44.1 kHz, set somewhat higher than the calculated Nyquist-Shannon sampling rate of 40 kHz for a sound upper limit of 20 kHz. Actual demodulation of FM narrowband signals in the ultrasonic range, using existing demodulation procedures, computers, telephones, mobile phones, stereo sound systems, etc., reproduces the original signal very poorly. This is unfortunate, because, as discussed above, carrier signals in the ultrasonic range have a very low signal-to-noise ratio due to the fact that there is very little natural "noise" at these high frequencies.

[0210] Devices, methods, and systems for measuring physiological signals (e.g., biological parameters) and wirelessly and silently transmitting digital information about those measurements use ultrasound signals that have a much improved signal-to-noise ratio compared to traditional telephone transmission methods. Methods and algorithms are also provided for receiving and demodulating ultrasound signals with great accuracy using existing computer and smartphone technology.

[0211] FIG. 21A shows a schematic diagram of the system including a data input 0433 (e.g., providing any type of information, including digital and / or analog information) and a microcontroller 0405. In some variations, the microcontroller includes or is coupled to a processing device for encoding a digital representation of the biological parameter, and this encoded signal may be converted into an ultrasound signal as described in more detail below. For example, the encoded signal may be transmitted in ultrasound by an ultrasound transducer 0407. In some variations, the microprocessor and transducer may be coupled together or formed as part of the same component 0405', or alternatively, the microprocessor may include a piezoelectric / speaker element. This ultrasound signal 0420 may then be received by a remote communication device 0425, including an audio pickup (receiver) 0429. The remote communication device 0425 may execute client control logic 0427 that receives the ultrasound signal and converts it so that it can be processed, e.g., prepares the remote communication device to convert it back to an electronic signal and interprets what type of signal it is (e.g., heart rate, body temperature, etc.).

[0212] FIG. 21B shows a schematic diagram of a system including a medical sensing device 0401 (e.g., a thermometer, blood glucose monitor, etc.) having a sensor 0403 for detecting a biological parameter from a patient (e.g., body temperature, heart rate, blood glucose, etc.) and a microcontroller 0405. The microcontroller may include or be coupled to a processing device for encoding a digital representation of the biological parameter, and this encoded signal may be converted to an ultrasonic signal as described in more detail below. For example, the encoded signal may be transmitted in ultrasound by an ultrasonic transducer 0407. This ultrasonic signal 0420 may then be received by a remote communication device 0425, which includes an audio pickup (receiver) 0429. The remote communication device 0425 may execute client control logic 0427 that receives the ultrasonic signal and converts it so that it can be processed, e.g., prepares the remote communication device to convert it back to an electronic signal, and interprets what type of signal it is (e.g., heart rate, body temperature, etc.).

[0213] Thus, the medical sensing device 0401 of this example includes a sensor (or sensor assembly) configured to sense one or more physiological signals, such as body temperature, heart rate, pressure (e.g., blood pressure), etc. The sensor can produce an electrical signal representative of the sensed physiological signal, which can be converted to one or more digital signals for input to a microcontroller or other associated components. This digital signal can typically be displayed on the device (not shown) or can be electrically encoded as part of a digital signal that can then be ultrasonically encoded (e.g., by techniques such as frequency shift keying) into ultrasonic sound and emitted from the device. The encoding of the signal can be performed by any suitable circuitry, including, for example, a microcontroller such as an MSP430 (e.g., AFE4110 from Texas Instruments).

[0214] The center frequency may be selected from any suitable ultrasonic frequency, including (but not limited to) 20 kHz. In some variations, the medical sensing devices described herein are configured to transmit only, so that data is transmitted to (but not received from) a remote communication device. In some variations, the medical sensing device is configured to both transmit and receive ultrasonic (sound) frequency information (see, e.g., FIG. 21C and FIG. 27). Additionally, in some variations, multiple channels (frequency channels) may be used.

[0215] In FIG. 21C, a schematic diagram of a medical sensing device (e.g., a wristlet configured as an “ECG watch” to detect ECG signals and transmit them to a telecommunications device) is shown. In this example, the device (e.g., wristlet) includes a sensor 0403. In some variations, the sensor may include two or more electrodes for detecting ECG signals. An ultrasound transducer may be configured as both an ultrasound transmitter and an ultrasound receiver. In some variations, the same transducer element (e.g., a piezoelectric element) may be used for both. The telecommunications device 0425 may be configured to both receive (via audio pickup 0429) and transmit (via ultrasound receiver 0433) ultrasound, such as the ultrasound transmitted by the medical sensing device 0401.

[0216] In one embodiment, the ultrasonic signal has a center frequency in the range of about 17 kHz to about 32 kHz, hi another embodiment, the frequency modulated ultrasonic signal has a center frequency in the range of about 18 kHz to about 24 kHz, or in the range of about 20 kHz to about 24 kHz.

[0217] 22 shows one variation of a digital signal encoded using shift keying. In this variation, the ultrasound signal is modulated at two different frequencies, one to indicate high ("1") and one to indicate low ("0"). For example, the frequencies for 0 and 1 may be selected centered around 20 kHz (e.g., 19.5 kHz and 20.5 kHz).

[0218] In some variations, as mentioned above, the sensor encodes an ECG signal, but in general, the sensor may include any suitable sensor operable to detect a physiological signal that the user wishes to observe. Multiple sensors may be included. Non-limiting examples of such physiological signals include, but are not limited to, respiration, heartbeat, heart rate, pulse oximetry, photoplethysmogram (PPG), body temperature, and the like. A respiration detector may be used. Heartbeat and heart rate may also be detected. For example, a person's hemoglobin oxygenation may be observed non-invasively and indirectly using a pulse oximetry sensor, rather than measuring directly from a blood sample. The sensor is placed on a thin part of the person's body, such as a fingertip or earlobe, and light containing both red and infrared wavelengths is passed from one side to the other. The change in absorbance of each of the two wavelengths is measured, and the difference is used to estimate the oxygen saturation of the person's blood and the change in blood volume at the skin. A photoplethysmogram (PPG) may then be obtained using a pulse oximeter sensor, or with an optical sensor using a single light source. The PPG can be used to measure blood flow and heart rate. A digital representation of this data can then be used and passed on as described herein. In some variations (described below with reference to Figures 26A and 26B), analog information can also be encoded and / or added to the digital information to form a hybrid of analog and digital information transmitted by the ultrasound transmitting device.

[0219] In some variations, the transducer assembly converts an electrical (e.g., digital, analog, etc.) encoding of the biological parameter into an ultrasonic signal that can be transmitted. In the embodiment shown in Figure 21A, the transducer assembly 0405' includes an ultrasonic transducer 0407 for outputting an ultrasonic signal. Non-limiting examples of suitable ultrasonic transmitters (including transducers) include, but are not limited to, miniature speakers, piezoelectric buzzers, and the like.

[0220] Within the remote communication device 0425, the ultrasound signal may be received by a microphone 0429 of a device such as, for example, a smartphone, a personal digital assistant (PDA), a tablet personal computer, a pocket personal computer, a notebook computer, a desktop computer, a server computer, or the like.

[0221] The volume of the signal may remain low to conserve power, but can also be louder because it is inaudible. For example, at ultrasonic frequencies, the signal can be made louder without worrying about the presence of a "listener" because it is inaudible. Additionally, the signal can be encoded to prevent other devices (not paired with the ultrasonic transmitting device) from receiving and understanding the signal.

[0222] As mentioned above, the remote communication device may include a processing device configured with client logic (e.g., software) for receiving and processing the ultrasound signal. For example, software on a smartphone may decode the ultrasound signal. Processing of the data may provide additional information relevant to the user, including the type of information (e.g., the nature of the biological parameter). For example, the signal may be coded to include (after a start identifier) ​​8 pulses indicating ECG data, 10 pulses indicating a thermometer reading (e.g., 4 digits with the last digit after the decimal point), 12 pulses indicating a blood pressure reading (e.g., 3 digits systolic blood pressure, 3 digits diastolic blood pressure, and 3 digits heart rate), 14 pulses indicating pulse oximeter data (e.g., 3 digits oxygen saturation and 3 digits heart rate), 16 pulses indicating glucometer data (e.g., 3 digits blood glucose level), etc. There may be a "break" between the digits and the EOM (end of message) indicator. In practice, the signal may be transmitted several times so that a comparison between the received data can be performed for verification.

[0223] In one variation, the signal may be encoded as follows (assuming 8-bit bytes and start and stop bits): some number of AA or 55 to allow synchronization, a byte indicating a version number, the remainder of the packet 1 byte long, a 1-byte packet identifier (0x01 for blood pressure, 0x02 for pulse oximetry, 0x03 for glucose, etc.), the data, and an 8-bit CRC.

[0224] In some variations, the signal may also include a spread of analog data (e.g., signal over time, signal over distance) for transmission along with digital information, including information for formatting the analog data or extracted from the analog data (e.g., scaling the analog data). For example, a signal for transmission by ultrasound from an ultrasound transmitting device may include one or more digital portions and one or more analog portions. The digital portions may include information extracted from the analog signal, such as scaling (e.g., maximum and / or minimum values), time lengths, averages, etc. Analog, digital, and analog and digital (hybrid) signals may be encoded, including cryptographically encoded, and / or may include error correction codes.

[0225] As mentioned, the signal may have a timestamp and / or date stamp. In some variations, the device or system may be configured to take multiple measurements and transmit them as a batch or burst to a telecommunications device. For example, measurements may be taken at times ti, t2, etc., stored in the device (e.g., thermometer, glucose meter, etc.), and later (tn) transmitted by ultrasound to a telecommunications device (e.g., smartphone, tablet, etc.). The data may be processed by the telecommunications device and / or uploaded to an external server or the like (e.g., the cloud).

[0226] The baud rate of the transmitted ultrasound data can be selected to allow for fast transmission. For example, if a baud rate of about 300 baud is used, the transmission can take less than one second, even for batched signals. In some variations, the baud rate is around 400.

[0227] As mentioned, the raw signals and derived information from the sensors may be displayed and stored locally on the smartphone as well as transmitted to a web server via an internet connection. Software on the web server may provide a web browser interface for real-time or historical display of signals and information received from the smartphone, including further analysis and reporting.

[0228] Ultrasound signaling as used herein generally refers to the use of ultrasound signals to transmit information such as the magnitude of a biological parameter along with the origin of the biological parameter measurement. As mentioned, these ultrasound signals may be coded to enable transmission and processing. The coded signals may then be converted to the ultrasound range by any suitable method. For example, one or more frequencies corresponding to different signal values ​​may be used, such as DTMF or DTMF frequency shifted to ultrasound frequencies. Another example of converting a signal is to use amplitude shift keying. Another example is to use frequency shift keying. Another example is to use phase shift keying. In some embodiments, multi-frequency signaling may be used, such as spread spectrum communication or multi-frequency carrier signaling. An example of multi-frequency carrier signaling is to specify a predetermined set of frequencies (e.g., between 20 kHz and 22 kHz, or between 20 kHz and 24 kHz, or generally between a lower limit of between 19 kHz and 20 kHz and an upper limit equal to or slightly lower than the Nyquist frequency of the intended receiver sampling rate) spaced apart by an interval, such as an interval between 40 Hz and 100 Hz, such as about 65 Hz, and for each such frequency, to code a bit "1" as indicating the presence of a carrier signal, such as a sine wave, at that frequency and a bit "0" as indicating the absence of such a signal. A receiver of such a multi-frequency signal may then perform a fast Fourier transform or related techniques known in the art to determine whether a carrier is available at each associated frequency, and thereby infer a set of bits that encode a number. In some embodiments of multi-frequency carrier signaling, for example when the signal is not well defined, multiple samples may be taken and averaged over time, and the average signal may be processed as described above. In some embodiments of multi-frequency carrier signaling, for example if the frequencies are close enough to cause interference, a Viterbi decoder may be used to decode the bit patterns. In general, techniques known to those skilled in the art of communications, particularly with respect to modulation and demodulation (e.g., modems), may be utilized.Examples of such techniques include the various modem standards designated as Vx (where x is an integer) promulgated by the International Telecommunications Union T Sector, which are incorporated herein by reference in their entirety for all purposes.

[0229] In some embodiments, a server may perform signal analysis to determine the encoded data rather than (or in addition to) on the remote communication device. In some embodiments, the signals may be stored on the server and provided to personnel for improvement of transmission and / or reception techniques.

[0230] As mentioned above, the signaling may be performed by a transmitter. The transmitter may include a hardware system incorporating a signal generator, such as a processing device, a microprocessor, a microcontroller, or a digital signal processor connected to a memory (e.g., DRAM or SRAM, which may be integrated with the processing device in some embodiments) containing program instructions executable by the processing device and / or data used by the program. The transmitter may also incorporate a persistent memory, such as a flash memory, coupled to the processing device and / or incorporated in the processing device. The signal generator may generate the ultrasonic signal to be transmitted as described above. In some embodiments, the waveform for transmission may be stored in persistent memory. In some embodiments, the transmitter includes a power source and / or battery, or uses a power source used to power other components of the medical sensing device. As mentioned, the transmitter may include a transducer, for example, a piezoelectric transducer that converts electrical impulses into ultrasonic vibrations. The transmitter may include an amplifier coupled to a processing device (e.g., an amplifier coupled directly or indirectly, e.g., via an audio digital-to-analog converter (DAC), which may be integrated with the processing device in some embodiments), through its output, which provides electrical impulses to the transducer. In some embodiments, the transmitter may include a receiver for receiving a real-time clock and / or a broadcast time signal. In some embodiments, the transmitter may include an encryption device, which may be, e.g., program instructions executed on the processing device or may be a separate integrated circuit. In some embodiments, the transmitter may include an error correction code generator and / or an error detection code generator, which may be, e.g., software instructions executed on the processing device or may be a separate integrated circuit. The techniques described herein with respect to transmitting and receiving acoustic wave signaling may be implemented in the transmitter described herein in a manner that would be readily understood by one of ordinary skill in the art.

[0231] In some variations, the transmission from the medical sensing device to the remote communication device is one-way, typically resulting in simplicity of design, lower cost, less power consumption, etc. These advantages are particularly useful when compared to systems in which the medical sensing device includes an additional receiver (including a microphone for receiving sonic signals, or an antenna). However, in some configurations, the medical sensing device may be adapted to receive a simple indicator signal from the remote communication device without adding a receiver such as an antenna or microphone. For example, in some variations, a return acknowledgement (ACK) may be implemented using an ultrasonic transducer (e.g., a piezoelectric speaker) as a 20 kHz sensor. For example, the remote communication device (e.g., a phone) may produce a short 20 kHz burst after receiving, decoding, and verifying the CRC to signal the sensor that it received the CRC correctly and that no retransmission is necessary. In other variations, a signal from the remote communication device may indicate that it is ready to receive a transmission from the biometric device. A time-separated signal / acknowledgement pair or pairs may also be used.

[0232] In one example, the device or system is configured such that the data transmitted by ultrasound includes forward error correction (FEC), allowing the receiver to correct N bit errors. This may be particularly useful when the system is configured such that the biometric device (medical sensing device) is transmit-only (e.g., one-way). The FEC may help ensure that the data is received correctly.

[0233] In some embodiments, data transmitted by ultrasound signaling may be processed to include error correction codes such as BCH codes, constant weight codes, convolutional codes, group codes, Golay codes such as Binary Golay codes, Goppa codes, Hadamard codes, Hagelbarger codes, Hamming codes, Latin Square-based codes, Lexicographic codes, sparse graph codes such as low-density parity check codes, LT or "Fountain" codes, Online codes, Raptor codes, Reed-Solomon codes, Reed-Muller codes, Repeat-accumulate codes, triple redundancy codes, Tornado codes, Turbo codes, or other error correction codes known to those skilled in the art. In various embodiments, such codes may be applied in a single dimension or multiple dimensions, may be combined, and may be combined with error detection codes such as parity and cyclic redundancy checks. The error correction codes may be decoded and applied to correct transmission and / or reception errors at the receiver or at a server receiving communication from the receiver according to respective techniques.

[0234] Example 1: Digital thermometer In one example, a digital thermometer may be configured to include a digital ultrasonic modem. In this example, a digital thermometer based on a Texas Instrument MSP430 digital thermometer is adapted to include firmware so that it can transmit a temperature reading (digital data) by ultrasound to a mobile telecommunications device (e.g., an iPhone®). While this example is specific to an APE 4110 microprocessor (a variation of Texas Instruments' MSP 430 microprocessor), other microprocessors may be used and similarly adapted with firmware, software, and / or hardware to function.

[0235] In general, the device may take data (e.g., temperature readings from a thermometer) and encode them for ultrasound transmission. The encoded signals may include error checking (e.g., CRC encoding, Hamming code, etc.) and may be encrypted. For example, the data may be data encrypted using, for example, the Advanced Encryption Standard (AES). U.S. Patent Nos. 5,481,255 and 5,452,356 both describe data encryption methods and techniques that may be used with the data described herein.

[0236] For example, data received from a thermometer may be coded and / or encrypted into one or more data packets for transmission. The microprocessor may code the data and then transmit the packets by driving a piezoelectric speaker. As mentioned above, frequency shift keying (FSK) may be used, in which two distinct ultrasonic frequencies (e.g., 18817 Hz and 19672 Hz) are used to transmit Boolean 0s and 1s, respectively. The control logic (data ultrasound modem logic) may both compose, code, and encrypt the data, and control the driving of the transmission of the prepared packets of coded / encrypted data by the speaker (e.g., a piezoelectric transducer). The control logic may also control the timing of the delivery so that there is an appropriate interval between each data bit. In addition, the control logic may also repeat the transmission and time the start of the transmission.

[0237] For example, in one variation, a thermometer normally measures body temperature, and when the temperature settles to a certain value, the thermometer emits an audible beep to inform the user that the value can be read. This thermometer (in its original unmodified configuration) includes a microcontroller (e.g., AFE4110) and a piezoelectric speaker, and the microcontroller drives the speaker to emit the beep. By modifying / configuring the microcontroller described herein to include control logic for a digital ultrasonic modem, the thermometer can be adapted to transmit the thermometer data "wirelessly" (via ultrasound) to a device configured to receive and decode / decrypt the signal, such as a smartphone running digital ultrasonic modem receiver logic.

[0238] In this example, the microprocessor may include the following (example) code to enable the functionality described above: Figures 23 and 24A-E show flow charts illustrating methods for transmitting data. These examples are not limited to digital thermometers and may be used with any of the devices described herein, including ECG transmission.

[0239] Although the above steps illustrate the methods of Figures 23 and 24A-24E for transmitting data, one of ordinary skill in the art will recognize many variations based on the teachings described herein. Steps may be completed in different orders. Steps may be added or omitted. Some of the steps may comprise sub-steps. Many of the steps may be repeated as often as is beneficial.

[0240] 23 and 24A-24E may be performed in conjunction with a circuit as described herein, such as a processing device or logic circuit of a computing device, or one or more of their accessories. The processing device or logic circuit may be programmed to provide one or more of the method steps, and the program may comprise program instructions stored in a computer-readable memory, or programmed steps of a logic circuit.

[0241] In any of the systems, devices, or methods described herein, data (including digital data, analog data, and / or hybrid digital / analog data) may be compressed before being encrypted. Any suitable data compression technique may be used. For example, data compression may be performed using lossy and / or lossless techniques. Known types of lossy and lossless data compression may be used. For example, Lempel-Ziv (LZ) compression and other statistical redundancy techniques may be used for lossless compression. Similarly, lossy data compression techniques may also be applied. A receiver executing the control logic may decompress the data.

[0242] As mentioned above, a receiver (digital ultrasound modem receiver) may be used to receive the transmitted ultrasound signal. The receiver may be a dedicated device that includes a microphone capable of receiving the ultrasound signal and a processing device (e.g., a microprocessor) capable of analyzing the signal, or may be a device having a microprocessor and a microphone adapted to receive the ultrasound signal when executing control logic (e.g., digital ultrasound modem receiver logic).

[0243] For example, FIG. 25 shows one variation of a flow diagram illustrating a method for receiving, demodulating, and detecting a digital ultrasound signal. In this example, an application (receiving control logic) receives binary FSK encoded data via a microphone input. For example, the input may be from a smartphone microphone. As discussed above, binary FSK encoding uses a "mark" frequency Fr to represent a binary value of 1, and a "space" frequency Fr to represent a binary value of 0. s In this implementation, no carrier wave is used.

[0244] The application consists of two largely independent components: a demodulator that extracts the mark and space frequency components from the raw audio data, and a packet decoder that observes the demodulated signal for packet transmission and decodes them. These are shown in Figure 25. The demodulator is a decoder that performs the demodulation for S>2*max(F m9 The system receives audio samples from the microphone hardware at a sample rate S such that G=S / abs(F8). The audio samples are processed by two frequency detectors that calculate the strength of the mark and space frequency components (respectively) of the received signal. The Goertzel algorithm is used for frequency detection in this implementation. To achieve sufficient frequency resolution between the mark and space frequencies, the Goertzel algorithm is applied to a sliding window of G samples, such that G=S / abs(F m -F).

[0245] The outputs of the Goertzel algorithm for the mark and space frequencies are passed through independent low pass filters with a passband equal to the baud rate. The filtered output of the space frequency signal is then subtracted from the filtered output of the mark frequency signal. This produces a waveform that is near zero when no transmission is taking place, goes up to a positive value when the "mark" frequency is active, and goes down to a negative value when the "space" frequency is active.

[0246] This demodulated waveform is then passed to a packet decoder. For each raw audio sample received from the microphone hardware, the demodulator produces a single demodulated sample of the demodulated waveform. The packet decoder receives the demodulated samples from the demodulator. The decoder maintains a buffer of the last N samples received, where N is equal to the length of the synchronization sequence. For each new sample, the decoder evaluates the past N samples in the buffer to determine whether they contain the synchronization sequence. A two-stage test is used: first a computationally simple evaluation that removes most false positives due to random noise, and then a more computationally expensive evaluation that removes the rest.

[0247] Once a valid synchronization sequence is received, the decoder stores the characteristics of the received signal (e.g., maximum mark / space amplitude, etc.). These equalization parameters are used to calibrate the decoder thresholds used to read the remainder of the packet. The decoder in this example then reads each encoded byte. The decoder uses the stored equalization parameters to determine the minimum amplitude threshold for the start bit of each byte. Once a valid start bit is received for a given byte, subsequent bits are evaluated based on the sign of the demodulated waveform, with no minimum threshold for decoding.

[0248] If a valid start bit is not received, the decoder stops reading packets and waits for silence, or some fixed amount of time, before resuming listening for a new packet. Each logical byte in a packet is actually transmitted as two coded bytes, the first containing the Hamming coded low nibble of the logical byte, and the second containing the Hamming coded high nibble.

[0249] The first logical byte read is the packet version, which is checked against the supported version numbers. Next the packet length is read, which specifies the number of data bytes that follow. If the packet length exceeds the maximum length for the specified packet version, the packet is rejected. Then each logical data byte is read.

[0250] After the data bytes are read, the two logical checksum bytes are read and the received checksum value is compared with the value calculated for the received data bytes. If these two checksum values ​​match, the packet is considered valid and is made available to the rest of the application. If they do not match, the packet is rejected. The two logical checksum bytes represent the end of the packet. After receiving the packet, the decoder resumes listening for a new packet.

[0251] Once the data is received (and in some variations decoded), it may be processed and / or stored and / or displayed and / or transmitted using any of the communications capabilities of the telecommunications device. For example, the data may be displayed on a smart phone and / or uploaded to a medical database for storage and / or later review.

[0252] Although the above steps illustrate the method of FIG. 25 for transmitting data, one of ordinary skill in the art will recognize many variations based on the teachings described herein. Steps may be completed in different orders. Steps may be added or omitted. Some of the steps may comprise sub-steps. Many of the steps may be repeated as often as is beneficial.

[0253] One or more of the steps of the method of Figure 25 may be performed in conjunction with circuitry as described herein, such as a processing device or logic circuitry of a computing device, or one or more of their accessories. The processing device or logic circuitry may be programmed to provide one or more of the steps of the method, and the program may comprise program instructions stored in a computer-readable memory or programmed steps of the logic circuitry.

[0254] While the above examples describe systems configured to transmit digital information, the techniques, devices, and systems described herein may also be configured to transmit analog signals and / or hybrid analog and digital signals. In general, the techniques described include the use of a timer (e.g., in a microcontroller) that transmits to a piezoelectric element to generate an ultrasonic signal. Alternatively, in some variations, the system uses a D / A converter to drive a speaker for a non-digital output. Additionally, in some variations of the system, the output is not a piezoelectric element, but a more conventional speaker (albeit in the ultrasonic range). Additional digital-to-analog (D / A) conversion may be performed during transmission.

[0255] For example, Figures 26A and 26B show one variation of a hybrid digital / analog format that may be used with an ultrasound transmitter. In general, the signal may include a digital component that is modulated or configured for ultrasound modem transmission. For example, the digital signal may be encoded as an FSK signal, and the data (e.g., analog data such as biometric data like ECG, blood oxygen / pulse oximetry, etc.) may be encoded as a frequency modulated waveform that is added to the digital information.

[0256] For example, in some variations, the ultrasound transmission device is configured as a pulse oximetry measurement / observation device. In this example, information obtained from the pulse oximetry may be scrutinized to extract information such as minimum values, maximum values, time length of the analog signal, and may be digitally encoded and stored (using one or more encryption and / or error correction codes) in a buffer and / or transmitted by ultrasound. The analog signal may be sent to a transmitting element and combined with a digital signal (or extracted signal) that may be received by a remote communication device. In an example of a device configured as a pulse oximetry device (e.g., a plethysmograph), the pulse oximetry device prepares a hybrid data / analog signal by determining the peaks, minimum values, time length, time intervals, etc. of the analog signal from the analog signal (e.g., a time-varying pulse oximetry signal). Thus, the hybrid signal may include extracted or tagged digital information as well as a waveform (or multiple waveforms) obtained from the device.

[0257] In some variations, the signal may be ECG data. The ECG header information may include digital information about the analog waveform that is added to the digital information such as time length, heart rate, and information about the ECG waveform such as interval data (if previously analyzed).

[0258] The signal may be encrypted and transmitted with a device or user specific identification code. In general, any of the devices described herein can encode data and an encryption key may be provided so that the receiving remote communication device (e.g., phone, tablet, pad, etc.) can read and understand the data.

[0259] There are many potential advantages to transmitting a hybrid analog / digital signal that can be read and understood by a remote communication device. For example, where the hybrid signal contains a series of values ​​(e.g., min / max values) and waveforms (e.g., ECG, heart rate, etc.). This type of hybrid digital / analog system may allow for more efficient communication than FSK value data alone.

[0260] For example, variations of ultrasound transmitting devices may include pedometers, activity monitors, heart rate monitors, etc. In some variations, the signal is formatted such that there is a finite number of points in the analog portion. The ultrasound transmitting device may then transmit a series of data points (including any data points, including calibration points). In one example, a heart rate graph may include 1000 points over 2 seconds (transmission time), representing a graph of biometric data over time. The signal may include digital values ​​(e.g., encoded as FSK) and analog (e.g., graphic) data. Such a hybrid signal may include the best characteristics of both digital-only and analog-only signals.

[0261] In one example, as previously mentioned above, the ultrasound transmission device is a thermometer including the ultrasound modem element described above. The ultrasound thermometer device is configured to include a temperature range of approximately 95°F to 106.7°F for the practical range of use. Thus, the body temperature may be transmitted, usually with a resolution of 0.1 (e.g., 8 bits may be all that is needed, since there are 120 values). In a device configured to encode byte metric data in a hybrid signal, the digital component of the signal may be added first, and may include information about the analog signal after a digital-only signal, but the analog signal may be added or embedded in the remainder of the signal, and the digital information may be extracted from the digital signal to be included therewith. An example of a hybrid signal may include a thermometer device as mentioned above, which displays the body temperature as a function of time, measured value, and / or recorded value, transmits maximum / minimum body temperature, time measured, etc., and finally, the signal may also include a body temperature waveform showing changes over time. Other devices and / or signals (hybrid signals) may include a glucose monitor signal (e.g., configuring the ultrasound transmitting device as a glucose meter, etc.), which may transmit a blood glucose signal (a digital signal including maximum, minimum, etc.) and one or more graphs showing the waveform of blood glucose levels over time, etc.

[0262] Preparing and transmitting a signal to include both analog and digital information may also allow the system to transmit more data in a compressed form as a waveform, which may be very efficient. For example, a prototype ultrasound transmitting device applies a particular sampling rate (e.g., 300 or 500 samples / second, each value being a 16-bit binary value). More data may be efficiently transmitted in a compressed form as a waveform. Including extracted information in the digital portion of the signal (such as the minimum and maximum values ​​of the analog signal) may allow for axis calibration to be performed on the analog portion of the signal, e.g., for display.

[0263] As mentioned, FIG. 26A shows one variation of a hybrid digital / analog format that may be used as described herein. In this example, the signal includes an initial digital component 0901 that is encoded for ultrasound transmission using a technique such as FSK (or any of the other techniques known in the art). The digital information may be broken down into bits, bytes, words, etc. as appropriate. The size and arrangement of the digital information may be predetermined. Error correction codes (e.g., Hamming code, etc.) may be included. In FIG. 26A, the signal includes a start bit or byte 0905, a sequence of calibration data 0907 extracted from the analog signal (e.g., maximum / minimum values), additional data 0909 about the analog signal (e.g., type, timing, date stamp / time stamp, etc.). Any other digital information may be included. The signal may then include an analog component 0903. In FIG. 26A, the analog signal is somewhat free and may last for a fixed or non-fixed length of time. In some variations, the entire signal may be repeated for reception by a remote communication device. 26B shows a similar variation of a hybrid signal format, where a digital component 0901 is added to an analog component 0903, and an additional digital component 0911 (an "end" signal) may be added at the end. In some variations, multiple analog components may be combined with multiple analog components. As described below, the entire signal may be encrypted before transmission.

[0264] In some variations, a hybrid digital / analog format may be used to encode stored data held by a device (ultrasound transmitting device) for a length of time. For example, stored data such as an hour's worth of data, a day's worth of data, or a week's worth of data (e.g., biometric data such as pedometer data) may be prepared as an analog signal (graph over time) that is described / calibrated by a digital data component and transmitted to a remote communication device.

[0265] In any of the devices, systems, and methods described herein, the ultrasound signals transmitted by the devices may be encrypted. Any suitable encryption method may be used, including key-based encryption methods such as Data Encryption Standard (DES), Advanced Encryption Standard (AES), etc.

[0266] In general, the encryption key for a particular device (e.g., an ultrasound transmitting device) may be presented on the device (or on the device's associated packaging, housing, etc.) so that it is readily available to a user of a receiving remote communication device. The encryption key may be prepared as a barcode or other machine-readable format (e.g., a QR code), particularly as a readable format that can be read using a receiving remote communication device of a modality different from ultrasound transmission. As used herein, references to presenting or displaying the encryption key on an ultrasound transmitting device are intended to encompass displaying a prepared representation (and particularly a machine-readable representation) on the ultrasound transmitting device, its packaging or associated structure (e.g., a housing, etc.). In some variations, the encryption key is prepared as a barcode or QR code and printed on the outside of the ultrasound transmitting device so that it can be photographed or scanned by the remote communication device. Machine-executable logic (e.g., client logic, software, firmware, etc.) on the remote communication device may then determine the encryption key and apply it to decrypt the ultrasound signal received from the ultrasound communication device.

[0267] In this way, an ultrasound transmitting device may be uniquely paired with a secret encryption key that can only be read by the remote communication device that owns and applies the encryption key. The encryption key is easily displayed and easily determined by the remote communication device. Thus, in some variations, each ultrasound transmitting device may have a unique ID printed on the device, providing a code that must match the remote communication device. Scanning the printed encryption key allows the remote communication device to decrypt the data.

[0268] Figure 27 shows generally one variation of a system including an ultrasound transmitting device ("source device" 01031) with a cryptographic key 01051 visible on the body of the device that can be read and applied by the remote communication device 01025 to decrypt the transmitted ultrasound transmission. Figure 27 also shows one variation of the device and system in which the ultrasound transmitting device ("source device" 01031) is in bidirectional (or limited bidirectional) communication with the remote communication device.

[0269] As mentioned above, it may be useful to have communication between a remote communication device (e.g., a smartphone or computer) and an ultrasonic transmitting device, such as a health / fitness sensing device, a home automation and security device (front door and window sensors, remote light switches, etc.), a potted water level detector, etc. For example, it may be useful to implement a half-duplex protocol so that the remote communication device (e.g., a smartphone / computer) can provide an acknowledgment (ACK) to the sensing device (source device or ultrasonic transmitting device) that it has successfully received the data (with a correct CRC) and stop retransmitting that data. Another use of this half-duplex protocol is to configure the remote device by sending parameters or information, such as calibration data, personal information, etc., from the remote communication device.

[0270] For simple acknowledgement, the piezoelectric element / speaker used by the device (ultrasound transmitting device) to transmit data can be used as a frequency tuned sensor. In general, the piezoelectric element for transmitting audio can also be configured as a receiver. Using a piezoelectric element as a receiving sensor requires a relatively "loud" signal (even if it is inaudible), so the signal must be at the resonant frequency of the piezoelectric element where the sensitivity of the piezoelectric element is highest. The time length and encoding of such a "frequency burst" can be configured to be easily recognized by the low power electronics of the health / fitness sensing device. For example, the acknowledgement pulse can be filtered and detected as the mere presence of a certain ultrasonic frequency for a predetermined length of time.

[0271] In some variations, symmetric two-way communication can be achieved using well-established telephone modem techniques by simply changing the carrier frequency into the ultrasonic range. For example, telephone modem modulation techniques based on FSK (Frequency Shift Keying), QAM (Quadrature Amplitude Modulation), and PSK (Frequency Shift Keying). These telephone modem techniques assume that only two devices are attempting to communicate. Radio frequency protocols can be used to enhance the modem protocols to allow multiple devices to communicate simultaneously without error.

[0272] Implementations of such two-way communication techniques may include sufficient additional processing power in the device to perform the signal processing necessary to demodulate and decode the received audio. This processing power may require additional battery power as well as physical space in the device. A partial list of existing modem communication standards that may be adapted for ultrasonic communication may include ITU V.21 (300 bps, FSK) and ITU V.22 (1200 bps, PSK (Phase Shift Keying)). For example, ftp: / / kermit.columbia.edu / kermit / cu / protocol.html, http: / / www.LSU.edu / OCS / its / unix / tutorial / Modem Tutorial / ModemTutorial.html, http: / / www.dtic.mil / cgi-bin / GetTRDoc?AD-ADA499556, http: / / alumni.media.mit.edu / ~wiz / ultracom.html, http: / / nesl.ee.ucla.edu / fw / torres / home / Dropbx / good_paper_mico_controller.pdf, http: / / edocs.nps.edu / npspubs / scholarly / theses / 2010 / Sep / 10Sep Please refer to web pages such as _Jenkinds.pdf.

[0273] 27, the source device may include an additional transducer / microphone for receiving ultrasonic signals from the remote communications device and for supporting processing (e.g., microprocessor / microcontroller logic) for controlling it, interpreting the communications (which may be coded and / or encrypted) and performing any instruction functions. Similarly, the remote communications device may include a speaker (piezoelectric element) configured to emit ultrasonic signals.

[0274] From the above description, it is apparent that the inventive concepts disclosed and claimed herein are well adapted to carry out the objects and obtain the advantages as set forth herein and as inherent in the inventive concepts disclosed and claimed herein. While the embodiments presented have been described for purposes of this disclosure, it will be understood that numerous modifications can be made that will be readily apparent to those skilled in the art and that will be accomplished within the spirit of the inventive concepts disclosed and claimed herein.

[0275] Example 2: Heart Rate Monitor Using Audio Tones to Transmit Heart Rate Any of the devices, systems, and methods described herein may be configured as a wireless (ultrasound) heart rate monitor adapted for use with a mobile telecommunications (computing) device such as a smartphone. See also Example 3 below, which describes a wearable ECG monitor that may also provide heart rate information (e.g., by extracting heart rate from a detected ECG signal). A wearable component (e.g., a wearable monitor) for sensing heart rate may be configured as a wristlet, anklet, armband, chest strap, belt (collectively "strap"), etc., and may wirelessly transmit information via any of the ultrasound methods described above, including the use of receiver control logic (e.g., software, hardware, etc.) to receive, store, and / or analyze the sensed (biometric) information.

[0276] Most heart rate monitors consist of a chest strap that incorporates an ECG amplifier, an R-wave detector, and circuitry to output a 5 kHz electromagnetic pulse, typically 50 ms wide, when an R-wave is detected. This electromagnetic pulse is detected by a watch or other receiver, which then measures the interval between the pulses and calculates and displays the heart rate. This configuration requires a special receiver that may not be present in a cell phone or computer, so without the additional equipment they cannot receive the heart rate information. The configuration is also limited in range to about one meter, as it typically uses short-range electromagnetic transmission.

[0277] In one variation of the devices and systems described herein, a heart rate monitor may include a strap (e.g., chest strap, wristlet, etc.) incorporating an ECG amplifier, an R-wave detector, and circuitry for outputting an audio period (signal) typically 5 ms wide (e.g., in the ultrasound frequency range of about 17 kHz to 30 kHz) when an R-wave is detected. This audio tone may be detected by a device such as a smartphone or other mobile computing device using the smartphone device's built-in microphone, which can then measure the interval between the tones and calculate and display the heart rate. The mobile computing device (e.g., a phone) may include software, firmware, or hardware (but is typically software, including applications or "apps" that may be downloaded from a remote server) for controlling the mobile device to receive and analyze the audio (e.g., ultrasound) tones, calculate the heart rate, and store, upload, and / or display the heart rate.

[0278] One advantage of this system is that since microphone circuitry is already present in the smartphone or other mobile computing device, no additional equipment is required to receive the heart rate information, and the range can be longer, up to 5m or more if desired depending on the loudness of the audio tone.

[0279] When audio tones in the range 16kHz-32kHz are used (e.g., ultrasound, 17kHz-30kHz, 17kHz-22kHz, etc.), they are inaudible to most people, do not interfere with music or speech, and are less susceptible to audio interference.

[0280] In some variations, the devices, methods and systems may be configured to allow multiple heart rate monitors to be used in close proximity, or for one receiving device to receive heart rate information from multiple users simultaneously, and it may be desirable for the heart rate information from each heart rate monitor to be uniquely identifiable so as not to interfere with each other.

[0281] For example, audio tones from each cardiac monitor may be uniquely coded for each monitor by using a range of tone durations, multiple tones of the same frequency with specific time separations, different audio frequencies, or a combination of these.

[0282] A first embodiment is one in which each heart monitor uses a different audio frequency that is sufficiently far apart to allow for Doppler shifts when the heart rate monitor is moving rapidly relative to the receiver, and to allow for frequency discrimination with a high signal-to-noise ratio.

[0283] Thus, each cardiac monitor does not have to be set to a specific tone frequency, but rather the frequency may be determined by a pseudo-random sequence the first time the cardiac monitor detects an R-wave heart rate signal after it is first attached, and the audio tone remains fixed until the cardiac monitor is removed, thus avoiding the need to uniquely code each monitor.

[0284] If the heart rate monitor emits audio tones in the range of 18kHz to 22kHz, a separation of 500Hz may be used, resulting in 9 audio operating frequencies available for each monitor.

[0285] Pseudo-random allocation of the frequency to be used may be achieved by providing a counter that increments with time from when the cardiac monitor is first attached to the body, so that the counter value when the first R wave is detected determines the audio frequency to be used. The audio frequency may be changed by removing the monitor from the body and reattaching it.

[0286] In the above example, in the unlikely event that two cardiac monitors are using the same frequency and are in close proximity, and therefore may have some potential for interference, the frequency of one monitor can be changed by removing and reinstalling it. The receiving device can also detect such interference and advise the user to remove and reinstall the monitor if necessary.

[0287] The receiving device can determine the audio tone frequency of a particular ultrasound transmitting device (in this example, a cardiac monitor) by performing a spectral analysis of the received audio. Once the audio tone frequency is known, a narrow audio filter is used to separate the tones from each cardiac monitor. The audio tones can then be detected and the heart rate calculated by measuring the intervals between the audio tones. Since the time length of each audio tone is fixed, this information can be used to filter out interference from other audio sources in the frequency band.

[0288] A second embodiment is one in which multiple devices (e.g., heart rate monitors) use audio tones with the same frequency but different durations. The duration of each tone can be measured by the receiving device. Only tones of a particular duration are used to calculate the heart rate for a particular heart rate monitor. If two heart rate monitors are nearby, such that the receiving device picks up audio tones from both monitors at the same time, the receiving device can distinguish between them based on the tone duration. Since the tone duration is short compared to the interval between tones (the interval between heart beats), it is unlikely that the audio tones will arrive at the same time, but if they do arrive at the same time, the receiving device can recognize this and adjust the heart rate calculation to compensate.

[0289] In some variations, the audio signal emitted when a heartbeat is detected may be digitally encoded (e.g., comprising a burst of multiple pulses at high frequency), and the encoding (burst pattern) may be unique as mentioned above or pre-selected (may be random) and may be reset by the user (e.g., by removing and reattaching the device).

[0290] Any of the examples discussed above may be included as part of a method, device, or system (including software). Thus, a system for measuring heart rate may include a monitor (e.g., a heart rate sensor, etc.) that includes a transducer for creating an audio signal (e.g., one or more pulses) timed to the patient's heart rate. Thus, the monitor operates as an audio repeater. The audio signal may be in the ultrasound range. The system may also include control logic for controlling a mobile device, such as a smartphone or tablet, to receive and analyze the audio signal timed to the user's heart rate. In some cases, a dedicated receiver may be used instead of or in addition to a smartphone that executes the control logic.

[0291] In one particular example, the system may include an application for use on a mobile device, such as a smartphone, that controls the smartphone to receive an audio signal emitted by the sensor using an internal audio pickup (microphone) and calculate the heart rate from this audio (e.g., ultrasonic) pulse signal.

[0292] Example 3: Wristlet for detecting movement and / or ECG signals 28A and 28B show another variation of a wearable device that may detect health parameters and transmit the health parameters ultrasonically to an observation station (e.g., a smartphone) that is controlled by control logic to receive and / or cause reception of information ultrasonically from the wearable device.

[0293] FIG. 28A shows an external view of one variation of the device, configured as a wristlet. The device may include one or more sensors for detecting biological parameters, such as motion / vibration sensors, and one or more electrodes. In FIG. 28A, the outer surface of the device is shown diagrammatically. A first conductive (e.g., metal) window 01151 is visible at the outer surface of the wristlet, and a second conductive (e.g., metal) window 01153 is visible at the inner surface of the wristlet. These electrodes may allow the user to press down on the electrode and wristlet to make electrical contact with the skin. The inner electrode may be in contact constantly or periodically during normal use. The conductive window may also be thermally conductive and may also be connected to a body temperature sensing module.

[0294] The wristlet may be flexible so that it can be wrapped around and secured to the wearer's wrist. The wristlet may be bendable so that it remains in place when bent around the wearer's wrist. In some variations, the wristlet is open. In some variations, the wristlet may be closed (forming a closed loop around the subject's wrist). The outer surface of the wristlet may be sealed from the inner surface to prevent damage and to make the wristlet sweat-proof and waterproof while worn.

[0295] As indicated above for the conductive window region, the outer portion of the wristlet may be adapted to transmit energy from the module within the wristlet through the outer protective housing. For example, the conductive window region indicated above. The region of the wristlet covering the ultrasound transducer 01184 may also be adapted to allow the passage of ultrasound signals. In some variations, the ends of the wristlet are adapted to allow the passage of ultrasound signals by including relatively rigid end caps that can readily transduce ultrasound energy. In some variations, the outer (e.g., polymeric) covering is made of a material known in the art to be relatively transparent to ultrasound. In some variations, the end region (or the opposite end region) may also be adapted to allow recharging of the device's battery.

[0296] FIG. 28B shows an exemplary internal schematic of a wristlet showing the internal modules (structures). As mentioned, any suitable sensors may be included, including any of those mentioned above. In this example, the wristlet includes a motion sensor 01186, which may be a high-precision motion sensor for tracking body movements. Other sensors in this example include a first electrode 01191 and a second electrode 01192 that may be electrically connected to conductive windows 01151, 01153 on the outer surface. In some variations, the outer surface is an electrode. In other variations, a conductive surface extends around the length of the inner surface of the wristlet (e.g., toward the lower electrode) so that it is likely to come into contact with at least a portion of bare skin on the wrist whenever the device is worn. Similarly, the outer conductive surface of the upper electrode may extend entirely around the outer (outward-facing) surface of the wristlet. Additional sensors may be included or omitted. For example, in one variation, the wristlet includes only a motion sensor and no electrodes.

[0297] In some variations, the wristlet also includes a haptic feedback element, a vibration motor 01194. The vibration motor may produce an oscillating frequency to provide feedback from the device to the user. In some variations, the wristlet may also include a button or contact area that allows the user to manually initiate one or more functions of the wristlet and / or the observation station, such as transmitting data via ultrasound. The button may be pressed or activated through an outer covering that protects the wristlet, and the outer covering may indicate by pattern, color, etc. where the button can be pressed.

[0298] The wristlet may also include one or more sensors, as well as a processing device 01183 for receiving and / or encoding information from an ultrasonic transducer 01184. As discussed above, the transducer may receive encoded / encrypted information from the processing device for transmission via ultrasound. When multiple sensors are included, information may be encoded to indicate which data is included.

[0299] One or more memory modules (not shown) may also be included for storing the recorded information. The memory may be integrated with the processing device. In some variations, a separate ultrasonic detector 01194 may also be used, or the ultrasonic transducer 01184 may be capable of both transmitting and receiving ultrasonic signals. Thus, two-way communication by ultrasonic waves may be possible between the device and an observation station (e.g., a smartphone running the control logic).

[0300] The wristlet may also include a power management system, including a battery 01182, which is typically rechargeable. The battery may be relatively low power (e.g., low voltage such as 1.5V) and sufficient to power the electronics and ultrasound transducer. The processing device may manage the power, including charging the battery. The system may indicate (e.g., by vibrating in an alert vibration pattern) that the battery is low and needs charging.

[0301] In operation, the wristlet may be worn and used to monitor the subject (e.g., physical activity) and may record and / or wirelessly transmit sensed values ​​of the subject. For example, motion sensor data may be detected and transmitted by ultrasound to a mobile computing device (e.g., a smartphone 01130). As discussed above, the sensed data may be coded and encrypted (e.g., as both analog and digital information), which may prevent interference between other devices (e.g., allowing for specific modulation between devices) and may also allow for error correction.

[0302] For example, a wristlet device (e.g., an activity monitor) may be worn by the subject. Once worn, the device may record the wearer's movements (activity). The device may also include additional sensors, such as a pair of electrodes. These electrodes may be used to measure an ECG across the patient (e.g., between the patient's arms) when the subject presses on the outer surface of electrode 1. In some variations, the pressing may cause the device to record electrical potentials during this period. The recorded electrical signals may include information about the heart rate and ECG, which may be passed on directly or may first be analyzed by a processing device and then passed on (including passing on any analyzed information).

[0303] The device may be configured to transmit data continuously (e.g., broadcast via ultrasound) and / or repeatedly, or may be configured to handshake with a smartphone (or other receiving station). For example, a wristlet device may be configured to standby until an ultrasound trigger ("ready") is received by the ultrasound transducer / detector (01184 / 01194). The wristlet may then communicate with the receiving station to transmit the collected data via coded / encrypted ultrasound as described above. The system may be configured to transmit periodically, or to attempt to transmit once sufficient data has been collected.

[0304] In general, any of the techniques, components, and / or subsystems described above may be used or combined with any of the other examples. For example, any of the ECG wristlet devices described herein may include any of the features mentioned above.

[0305] Example 3: ECG detection watch Another variation of an ECG measurement device configured to detect ECG signals and transmit ultrasound signals encoding ECG data is shown in Figs. 29 and 30. In this example, a watch is modified to include two electrodes. A first electrode (not visible in Figs. 29 and 30) is placed on the back of the watch (the "wristlet") and contacts the wrist of the person wearing the device. A second electrode 01203 is placed on the "front" of the watch 01201 as shown in Fig. 29. Thus, the watch can operate as a one-lead ECG sensor, recording lead I (left arm / right arm). In some variations, the watch may include an additional electrode 01207, for example next to the watch or strap area, which can be held against the subject's leg (right leg or left leg) to produce additional / alternate leads (e.g., lead II, lead III, etc.).

[0306] The watch may also include one or more controls and / or indicators. For example, the watch may be configured as a clock (to show time, etc.). The watch may include buttons, dials, etc. for selecting functions (e.g., turning ECG measurements on / off, beginning transmission of ECG information, etc.).

[0307] FIG. 30 shows a variation of the ECG device 01203 shown in FIG. 29, transmitting to a mobile telecommunications device 01205. In this example, the mobile telecommunications device is a smartphone (iPhone®) configured to act as a receiving station for the ECG watch and receive ultrasound transmissions of ECG information. The smartphone is thus running application software such that a processing device of the smartphone "listens" to the ultrasound signal to an audio receiver (microphone) that senses the ultrasound. The receiving device (smartphone) may then process the signal and display it in real time as the ECG signal is recorded, as shown in FIG. 30. In this example, the smartphone is continuously receiving, displaying, and recording the signal.

[0308] As mentioned, the signal may be processed before being displayed and / or stored and / or transmitted. For example, the signal may be filtered to remove artifacts and / or to smooth. The signal may also be analyzed to automatically detect cardiac events (e.g., arrhythmias). Processing may be performed by the watch prior to ultrasound transmission, by the receiving device (e.g., a smartphone) after transmission to the receiving device, or may be split between them.

[0309] In some variations, the watch may determine / verify that a receiving device (e.g., a smartphone) is ready to receive information, as discussed above. In some variations, half-duplex or full-duplex may be used. The watch may continuously broadcast the ECG data, or may transmit only when a receiver indicates it is ready to receive. In such variations, the device may store the detected ECG data for later transmission.

[0310] In the examples shown in Figures 29 and 30, the system also determines the heart rate from the ECG information. Additional information may also be extracted from the signal. As mentioned above, the signal may be transmitted by the device (e.g., a wristlet) as a digital ultrasound signal, an analog ultrasound signal, or a hybrid digital / analog ultrasound signal. Additionally, the signal may be encoded. In some variations, as discussed above, the device includes a key that can be scanned by the smartphone to provide decoding / pairing between the smartphone (receiver) and the device.

[0311] While many of the exemplary devices described herein are wearable devices (e.g., wristlets, chest bands, pendants, jewelry, etc.), the principles, modules, subsystems, and elements described herein may be used for other devices, particularly biological sensor devices. For example, a case or holder for a mobile telecommunications device (e.g., a smartphone) may incorporate any of these aspects, such as encoding the ultrasound signal, encoding as a hybrid digital / analog ultrasound signal, etc. Thus, in addition to wearable medical sensors, any standalone medical sensor may also include any of these features.

[0312] When a feature or element is referred to herein as "in contact with" another feature or element, it may be directly in contact with the other feature or element, or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as "directly in contact with" another feature or element, there are no intervening features or elements. It will also be understood that when a feature or element is referred to as "connected," "attached," or "coupled" to another feature or element, it may be directly connected, attached, or coupled to the other feature or element, or intervening features or elements may be present. In contrast, when a feature or element is referred to as "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated may also apply to other embodiments. It will also be understood by those skilled in the art that a reference to a structure or feature being disposed "adjacent" another feature may have an overlapping portion with, or an underlying portion of, the adjacent feature.

[0313] The terms used herein are intended to describe only certain embodiments and are not intended to limit the present invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising" as used herein specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0314] Spatially relative terms such as "under," "below," "lower," "over," "upper," and the like may be used herein for ease of description to describe the relationship of an element or feature to another element or feature shown in the figures. It will be understood that the spatially relative terms are intended to encompass various orientations of the device in use or operation in addition to the orientation shown in the figures. For example, if the device in the figures is inverted, an element described as being "under" or "beneath" the other element or feature would be oriented "directly above" the other element or feature. Thus, the exemplary term "directly below" can encompass both an orientation directly above and directly below. The device may be oriented differently (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, terms such as "upwardly," "downwardly," "vertical," "horizontal," and the like are used herein for descriptive purposes only, unless expressly indicated otherwise.

[0315] Although the terms "first" and "second" may be used herein to describe various features / elements, these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element discussed below may be referred to as a second feature / element, and similarly, a second feature / element discussed below may be referred to as a first feature / element, without departing from the teachings of the present invention.

[0316] When used in this specification and claims, including when used in the examples, unless expressly specified otherwise, all numbers may be read as if preceded by the words "about" or "approximately", even if these words are not expressly present. The phrases "about" or "approximately" may be used when describing a size and / or location to indicate that the described value and / or location is within a range of reasonably expected values ​​and / or locations. For example, a numerical value may have a value of + / -0.1% of the stated value (or range of values), + / -1% of the stated value (or range of values), + / -2% of the stated value (or range of values), + / -5% of the stated value (or range of values), + / -10% of the stated value (or range of values), etc. Any numerical range described herein is intended to include all subranges subsumed therein.

[0317] While preferred embodiments of the present disclosure have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It is understood that various alternatives to the embodiments of the invention described herein may be utilized in practicing the invention. The following claims define the scope of the invention, and it is intended that methods and structures within the scope of these claims and their equivalents be covered thereby.

[0318] FIG. 31 is a flow diagram of a method 3101 for performing a 12-lead ECG with a three-electrode device according to some embodiments of the present disclosure. The method 3101 may be performed by processing logic comprising hardware (e.g., circuitry, dedicated logic, programmable logic, microcode, etc.), software (e.g., instructions executed on a processing device to perform a hardware simulation), or a combination thereof. In one embodiment, processing logic corresponding to one or more components or methods of FIGS. 1-30 may perform one or more of the following operations. For example, in one embodiment, the processing logic of the processing device 1110 performs the following operations with respect to the individual components of FIGS. 1-30. In another embodiment, any other suitable processing device may perform the described operations.

[0319] Referring to FIG. 31 , in block 3103, the processing logic may determine a Lead I (value) from the first electrical signal of the first electrode and the second electrical signal of the second electrode. Lead I may be calculated according to any of the methods described herein. For example, Lead I may be calculated based on electrical signals from a first electrode contacting a first upper limb of the user and a second electrode contacting a second upper limb of the user. In block 3105, the processing logic may determine a Lead II from the second electrical signal and a third electrical signal from a third electrode. In one embodiment, Lead II may be calculated according to any of the methods described herein. For example, Lead II may be calculated based on electrical signals from a second electrode contacting a second upper limb of the user and a third electrode contacting a first lower limb of the user. In one embodiment, Lead I and Lead II are measured in sequence (e.g., the user first places electrodes for Lead I and obtains measurements, then places electrodes for Lead II and obtains corresponding measurements). In such a case, the processing logic may further align Lead I and Lead II in time. In another embodiment, Lead I and Lead II are measured simultaneously (e.g., a user places electrodes for Lead I and Lead II and obtains both measurements contemporaneously, concurrently, or substantially simultaneously).

[0320] In block 3107, the processing logic may generate Lead III (e.g., using (Lead III=Lead II-Lead I)). In another embodiment, Lead III may be generated directly from the electrical signals of the electrodes contacting the user. In block 3109, the processing logic may determine Leads aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 based on Lead I, Lead II, and Lead III by the processing device using a machine learning model trained using the measured 12-lead ECG data. In one embodiment, only data for Leads I, II, and III is provided to the machine learning model, which provides a 12-lead output using only data for Leads I, II, and III. In another embodiment, additional data may be used by the model, as described below with respect to FIG. 32.

[0321] In another embodiment, the processing logic may determine leads aVR, aVL, and aVF from leads I and II using a non-machine learning based technique. In yet another embodiment, the processing logic may further determine the V lead from the fourth electrical signal. For example, the processing logic may determine V2 or V5 or any other V lead based on the fourth electrical signal. The processing logic may then determine the lead and the remaining V lead based on leads I, II, III, and V leads by the processing device using a machine learning model trained using the measured 12-lead ECG data.

[0322] At block 3111, the processing logic may provide the following leads for display on the client device: Lead I, Lead II, Lead III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6. In another embodiment, a subset of the 12 leads (or none of them) may be provided.

[0323] In one embodiment, the machine learning model is built based on a deep convolutional structure. The input layer treats the multi-lead ECG as a spatial image with one dimension for the time axis and another dimension for the channels. The ECG channels may have the usual order of leads I, II, III, AVR, AVL, V1-V6. Alternatively, the ECG channels may have a more physiologically meaningful order called "Cabrera format", where the anterior leads are in the order of leads aVL, I, -aVR, II, aVF, III, V1-V6. In another input format, only the limb leads and the actually measured precordial leads in the Cabrera format are used to form the input ECG image.

[0324] A 2D convolutional layer may be used to process the input ECG images instead of a 1D convolutional model as used by most other ECG training models. The training model may include 4x10 blocks of convolutional / residual layers followed by a 2x4 fully connected layer. The output layer is a multi-classification layer where more than one class may be identified, such as "myocardial infarction" and "left atrial hypertrophy", or "right bundle branch block" and "inferior ischemia".

[0325] In one embodiment, the model is trained using a large labeled training set with many epochs. Random connection pruning and batch normalization can be used to prevent overfitting and increase generality. The data is split into a training set, a validation set, and a test set. The validation set is used to prevent overfitting and training during the training process. The test set is used for final performance validation. The dataset is first formed using an existing 12-lead diagnostic ECG database. Then, a second dataset is formed using actual sampled ECGs from the target device described herein. Transfer learning can be used to train only a few layers of the deep learning model for the second dataset.

[0326] FIG. 32 is a flow diagram of a method 3201 for machine learning training of a 12-lead ECG with a three-electrode device, according to some embodiments of the present disclosure. The method 3201 may be performed by processing logic comprising hardware (e.g., circuitry, dedicated logic, programmable logic, microcode, etc.), software (e.g., instructions executed on a processing device to perform a hardware simulation), or a combination thereof. In one embodiment, processing logic corresponding to one or more components or methods of FIGS. 1-30 may perform one or more of the following operations. For example, in one embodiment, the processing logic of the processing device 1110 performs the following operations with respect to the individual components of FIGS. 1-30. In another embodiment, any other suitable processing device may perform the operations described.

[0327] 32, at block 3207, the processing logic may train a machine learning model using the 12-lead ECG data corresponding to a population of individuals. In another embodiment, the model may be trained using data from a single individual (e.g., a user from whom an ECG is to be determined). In one example, the machine learning model may be trained to correlate measured data from leads I, II, and III with the measured 12-lead data. Once trained, the machine learning model may accurately predict each lead of the 12-lead ECG using only data from leads I, II, and III.

[0328] Optionally, at block 3203, the processing logic may pre-process the 12-lead ECG data to classify the data based on at least one of height, sex, weight, or nationality before it is used to train the machine learning model. By pre-processing in this manner, the model may be trained more efficiently and provide more accurate results specific to the user for whom the 12-lead ECG is to be determined. For example, the processing logic may classify the 12-lead ECG data based on the characteristics of the individual (3205). In one embodiment, if an individual is identified as male, the 12-lead ECG data may be pre-processed to include only data corresponding to male subjects. In another embodiment, if an individual is identified as having a particular nationality, the data may be pre-processed to include only that particular nationality. Training the model using such pre-processed data may enable faster training of the model and providing more accurate results than was previously possible without such pre-processing.

[0329] In one embodiment, features of the 12-lead data may be selected, extracted, and labeled for predicting the 12-lead ECG from three leads in real time, for example, by performing one or more machine learning operations. Such operations may be selected from among feature ranking, feature classification, feature labeling, feature predicting, and feature clustering operations. Alternatively, or in combination, the extracted features may be labeled and stored for offline training of a machine learning algorithm or a set of machine learning operations. For example, the operations may be selected from any of the above operations. Any number of machine learning algorithms or methods may be trained to predict the 12-lead ECG from three leads. These may include the use of decision tree learning, such as random forests, association rule learning, artificial neural networks, inductive logic programming, support vector machines, clustering, Bayesian networks, reinforcement learning, representation learning, similarity and distance learning, sparse dictionary learning, etc.

[0330] Machine learning based algorithms or operations for predicting 12-lead ECG from 3 leads may be provided as a service from a remote server that may interact or communicate with a client program, e.g., a mobile app, provided on a user's computing device. The interaction or communication may be through an application program interface (API). The API may provide access to machine learning operations, for example, for ranking, clustering, classifying, and predicting 12-lead ECG from 3 leads.

[0331] Machine learning based algorithms or operations provided through a remote server and / or on a local application on a local computing device may operate on, learn from, and make analytical predictions from the 12-lead data and / or the 3-lead data, for example, from a population of users.

[0332] The comparison and analysis described herein can be used to draw conclusions and insights about the patient's health status, including health problems the patient may experience at the time of measurement or in the future. The conclusions and decisions can be predictive of future health conditions or diagnostic of conditions the patient already has. The conclusions and decisions can also include insights about the effectiveness or risks associated with drugs or therapeutics that the patient may be taking, may have taken, or may be considering taking in the future. In addition, the comparison and analysis can be used to determine actions and activities that may reduce or increase the risk of an adverse event. Based on the comparison and analysis described herein, the ECG data can be classified according to the level of risk that an adverse event exists. For example, the ECG data can be classified as normal, low risk, medium risk, high risk, and / or abnormal. The designation of normal and abnormal may require evaluation, diagnosis, and / or confirmation by a health care professional.

[0333] Diagnoses and determinations of abnormalities, adverse events, or disease states by physicians and other health care professionals may be transmitted to the server and database and tagged with and associated with the corresponding ECG data. The diagnoses and determinations may be based on analysis of the ECG data or may be determined using other testing or investigation procedures. The professional diagnoses and determinations may be extracted from the patient's electronic health record, entered into the system by the patient, or entered into the system by the medical professional. The system's conclusions and determinations may be compared to the actual diagnoses and determinations by the medical professional to validate and / or improve the machine learning algorithms used by the system. The time and length of time that the abnormality, adverse event, or disease state occurred may also be included in the database, so that the ECG data corresponding to the occurrence and / or the ECG data before and / or after the abnormality, adverse event, or disease state can be associated and analyzed together. The length of time before or after the abnormality may be predetermined and may be up to 1 day to 30 days, or may be longer than 1 month to 12 months. Analysis of the time prior to the abnormality, adverse event, or disease state may enable the system to identify patterns or correlations of various ECG features that precede the occurrence of the abnormality, adverse event, or disease state, thereby detecting or warning of the abnormality, adverse event, or disease state in advance. Analysis of the time after the abnormality, adverse event, or disease state may provide information regarding the effectiveness of treatment and / or provide the patient or physician with information regarding the progression of the disease, such as whether the patient's condition is improving, worsening, or remaining the same. The diagnosis and decision may also be used for indexing purposes, for example, by including it in the metadata associated with the corresponding ECG data.

[0334] As described herein, various parameters may be included in the database along with the ECG data. These may include the patient's age, sex, weight, blood pressure, medications, behavior, habits, activities, food consumption, beverage consumption, medications, medical history, and other factors that may affect the patient's ECG signal. The additional parameters may or may not be used in comparing changes in the ECG signal over time and circumstances.

[0335] Conclusions, decisions, and / or insights about the patient's health generated by the system may be communicated to the patient directly or via the patient's caregiver (physician or other health care professional). For example, the patient may be sent an email or text message that is automatically generated by the system. The email or text message may be a notification instructing the patient to log on to a secure site to retrieve the full conclusion, decision, or insight, or the email or text message may include the conclusion, decision, or insight. Alternatively or additionally, the email or text message may be sent to the patient's caregiver. Notifications may also be provided via an application on a smart phone, tablet, laptop, desktop, or other computing device.

[0336] As described herein, the system can identify behaviors, habits, activities, foods, beverages, medications, drugs, etc. that are associated with the patient's abnormal ECG readings. In addition to informing the patient of these associations, the system can provide instructions or recommendations to the patient to avoid those behaviors, habits, activities, foods, beverages, medications, drugs, etc. that are associated with the patient's abnormal ECG readings. Similarly, the system can identify behaviors, habits, activities, foods, beverages, medications, drugs, etc. that are associated with normal or improving ECG readings and can instruct or recommend the patient to perform those behaviors, habits, and activities and / or consume those foods, beverages, medications, and drugs. The patient can avoid future health problems by changing behaviors, habits, or adopting any activity guidelines, including but not limited to taking medications, medications, or following dietary or exercise programs, as instructed or recommended by the system, which may be predetermined activity guidelines recommended by the system independent of any analysis of the ECG data and / or may be derived from insights learned through the system and methods as described herein. Additionally, the system's insights may relate to general fitness and / or mental well-being.

[0337] The ECG data and associated metadata and other related data as described herein may be stored in a central database, a cloud database, or a combination of the two. The data may be indexed, searched, and / or categorized according to any of the characteristics, parameters, or criteria described herein. The system may analyze ECG data of a single patient, or the system may also analyze ECG data of a group of patients, where the group of patients may be selected according to any of the characteristics, parameters, or criteria described herein. When analyzing data from a single patient, it may be desirable to reduce and / or correct for intra-individual variability in the ECG data such that a comparison of one set of ECG data taken at a particular time with another set of ECG data taken at another time reveals differences due to changes in health conditions, rather than changes in the type of ECG recording device used, changes in lead and electrode placement, changes in skin condition (i.e., dry, sweaty, with or without conductive gel), etc. As described above, consistent lead and electrode placement can help reduce variability in ECG measurements. The system can also retrieve the patient's ECG data taken under similar circumstances and analyze this subset of the ECG data. [Explanation of symbols]

[0338] 300 cases 301 Mobile telecommunications devices 309 Electrode 311 Electrode 313 Electrode 400 equipment 509 Electrode 511 Electrode 513 Electrode 609 Electrode 611 Electrode 613 Electrode 709 Electrode 805 Electrode Unit 809 Electrode 811 Electrode 813 Electrode 909 Electrode 911 Electrode 913 Electrode 0401 Medical sensing devices 0403 Sensor 0405 Microcontroller 0407 Ultrasonic transducer 0420 Ultrasonic Signal 0425 Telecommunications Devices 0427 Client Control Logic 0429 Audio Pickup 0431 Source Device 0433 Data Entry 01005 Microcontroller 01007 Ultrasonic transducer 01025 Telecommunications Devices 01027 Client Control Logic 01029 Audio Pickup 01031 Source Device 01033 Input 01033 Ultrasonic transducer 01051 Encryption key 01053 Encryption key input 01130 Smartphone 01165 User button 01182 Battery 01183 Processor 01184 Ultrasonic transducer 01186 Sensor 01190 Vibration motor 01192 Electrode 01194 Ultrasonic detector 01201 Watch 01203 Electrode 01205 Mobile telecommunications devices 01207 Electrode 1009 Electrode 1100 Computing Devices 1110 Processor 1120 Memory 1130 Storage 1140 Network Interface 1150 Local Interface 1160 Operating Systems 1170 Application 1 1180 Application 2 1190 User Interface 1195 Display 1200 External Devices 1210 Sensor 1215 Connection 1220 Processor 1230 Local Interface 1235 Connection 2100 Smartphone 2110 Front 2120 Edge 2130 Back 2140 Display 2200 Smartphone Protective Case 2210 Electrode 2220 Electrode 2230 Electrode 3100 Tablet Computer 3110 Front 3120 Edge 3130 Back 3140 Display 3200 Tablet Computer Protective Case 3210 Electrode 3220 electrode 4100 Keyboard 4200 Keyboard Accessories 4210 Electrode 4220 Electrode 5100 Laptop Computer 5200 Sensor Accessories 5210 Electrode 5220 Electrode

Claims

1. an electrocardiogram device having a first electrode assembly, a second electrode assembly, and a third electrode assembly with a first electrode, a second electrode, and a third electrode adapted to measure a first electrical signal, a second electrical signal, and a third electrical signal, respectively, of an individual, the first electrode, the second electrode, and the third electrode being disposed on an outer anterior surface and an outer posterior surface of the electrocardiogram device; determining a lead I from the first electrical signal and the second electrical signal; determining a lead II from the second electrical signal and the third electrical signal; Generate lead III using (lead III = lead II - lead I), determining leads aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 based on lead I, lead II, and lead III using a machine learning model that is trained using the measured 12-lead ECG data; Provides leads named Lead I, Lead II, Lead III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 for display on the client device and a processing device for: The apparatus, wherein Lead I and Lead II are determined in sequence, and the processing device further aligns Lead I and Lead II in time to compare two sets of measurement results over the same simulated time period.

2. 2. The apparatus of claim 1, wherein the processing device is further for training the machine learning model using the 12-lead ECG data corresponding to a population of individuals.

3. 3. The apparatus of claim 2, wherein the processing device is further for pre-processing the 12-lead ECG data to classify the 12-lead ECG data based on at least one of height, sex, weight, or nationality before the data is used to train the machine learning model.

4. The apparatus of claim 3 , wherein the processing device is further for characterizing the 12-lead ECG data based on characteristics of the individual.

5. 2. The apparatus of claim 1, wherein the processing device is further for training the machine learning model using only the 12-lead ECG data corresponding to the individual.

6. 1. A method for generating a 12-lead electrocardiogram, comprising: determining, by a processing device, a lead I from the first electrical signal of the first electrode and the second electrical signal of the second electrode; the processing device determining Lead II from the second electrical signal and a third electrical signal from a third electrode, the first electrode, the second electrode, and the third electrode being disposed on an outer anterior surface and an outer posterior surface of an electrocardiogram device; generating a Read III using the processing device (Read III=Read II-Read I); said processing device determining leads aVR, aVL, and aVF from leads I and II; determining leads V1, V2, V3, V4, V5, and V6 by the processing device based on Lead I, Lead II, and Lead III using a machine learning model trained using the measured 12-lead ECG data; and wherein the processing device provides the following leads for display on a client device: Lead I, Lead II, Lead III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6; The method, wherein Lead I and Lead II are determined in sequence, the method further comprising the processing device aligning Lead I and Lead II in time to compare two sets of measurement results over the same simulated period of time.

7. The method of claim 6, further comprising a step in which the processing device trains the machine learning model using the 12-lead ECG data corresponding to a population of individuals.

8. The method of claim 7, further comprising a step in which the processing device pre-processes the 12-lead ECG data to classify the 12-lead ECG data based on at least one of height, gender, weight, or nationality before the data is used to train the machine learning model.

9. The method of claim 8, further comprising a step in which the processing device classifies the 12-lead ECG data based on characteristics of the individual.

10. The method of claim 6, further comprising a step in which the processing device trains the machine learning model using only the 12-lead ECG data corresponding to an individual.

11. A non-transitory computer-readable storage medium storing instructions that, when executed by a processing device, cause the processing device to: determining a lead I from the first electrical signal of the first electrode and the second electrical signal of the second electrode; determining Lead II from the second electrical signal and a third electrical signal from a third electrode, the first electrode, the second electrode, and the third electrode being disposed on an outer anterior surface and an outer posterior surface of an electrocardiogram device; Determine leads aVR, aVL, and aVF from leads I and II; (Lead III = Lead II - Lead I) was used to generate Lead III, causing the processing device to determine leads V1, V2, V3, V4, V5, and V6 based on leads I, II, and III using a machine learning model trained using the measured 12-lead ECG data; providing leads named Lead I, Lead II, Lead III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 for display on a client device; The non-transitory computer-readable storage medium, wherein the Lead I and the Lead II are determined in sequence, and the instructions further cause the processing device to time-align the Lead I and the Lead II to compare two sets of measurement results over the same simulated time period.

12. 12. The non-transitory computer-readable storage medium of claim 11, wherein the processing device is further for training the machine learning model using the 12-lead ECG data corresponding to a population of individuals.

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