12-lead electrocardiogram using a 3-electrode device

Abstract

To provide a twelve-lead electrocardiogram using a three-electrode device.SOLUTION: There is provided an apparatus includes an electrocardiograph device comprising a first electrode, a second electrode, and a third electrode which are adapted to measure first, second, and third electrical signals, respectively. The apparatus further includes a processing device configured to: determine a lead I from the first and second electric signals (S3103); determine a lead II from the second and third electric signals (S3105); generate a lead III using (lead III=lead II-lead I) (S3107); determine leads aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6, using a machine learning model trained using measured twelve-lead ECG data, on the basis of the lead I, lead II and lead III, (S3109); and provide these leads, for displaying the same on a client device (S3111).SELECTED DRAWING: Figure 31

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 62 / 946,331, filed on December 10, 2019, and U.S. Non - Provisional Application No. 17 / 116,905, filed on December 9, 2020, the entire contents of which are incorporated herein by reference.

[0002] This disclosure relates to consumer and medical devices, systems, and methods. Specifically, this disclosure relates to devices and related systems and methods for observing a person's physiological state, and more specifically, to such devices, systems, and methods for using computing devices such as personal computers, laptop computers, tablet computers, smartphones, wearable computing devices, etc. to observe electrocardiograms (ECGs), heart rates, and arrhythmias.

Background Art

[0003] Cardiovascular diseases are a major cause of death worldwide. It can be said that 30% of the world's deaths in 2008 were due to cardiovascular diseases. It is also estimated that by 2030, more than 23 million people will die annually due to cardiovascular diseases. Cardiovascular diseases are equally observed in people in high - income countries and people in low - income countries.

[0004] An arrhythmia is a condition of the heart where the electrical activity of the heart is irregular, or faster (tachycardia) or slower (bradycardia) than normal. Many arrhythmias are not life - threatening, but some can cause cardiac arrest and even sudden cardiac death. In fact, arrhythmia is one of the most common causes of death during transportation to the hospital.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

[0006] The novel features of the present disclosure are particularly set forth in the appended claims. A further understanding of the features and advantages of the present disclosure can be obtained by reference to the following detailed description of embodiments that explain the principles of the present invention and the accompanying drawings of the embodiments. [Brief Description of the Drawings]

[0007] [Figure 1] It is a schematic diagram of a system for measuring and observing biometric parameters or physiological parameters according to many embodiments. [Figure 2A] It is a diagram showing a biometric or physiological parameter measurement and observation system including a smartphone and a smartphone protective case according to many embodiments. [Figure 2B] It is a diagram showing a biometric or physiological parameter measurement and observation system including a smartphone and a smartphone protective case according to many embodiments. [Figure 2C] It is a diagram showing a biometric or physiological parameter measurement and observation system including a smartphone and a smartphone protective case according to many embodiments. [Figure 2D]This figure shows a bitometric or physiological parameter measurement and observation system comprising a smartphone and a smartphone protective case, according to various embodiments. [Figure 2E] This figure shows a bitometric or physiological parameter measurement and observation system comprising a smartphone and a smartphone protective case, according to various embodiments. [Figure 2F] This figure shows a bitometric or physiological parameter measurement and observation system comprising a smartphone and a smartphone protective case, according to various embodiments. [Figure 2G] This figure shows a bitometric or physiological parameter measurement and observation system comprising a smartphone and a smartphone protective case, according to various embodiments. [Figure 2H] This figure shows a bitometric or physiological parameter measurement and observation system comprising a smartphone and a smartphone protective case, according to various embodiments. [Figure 2I] This figure shows a bitometric or physiological parameter measurement and observation system comprising a smartphone and a smartphone protective case, according to various embodiments. [Figure 2J] This figure shows a bitometric or physiological parameter measurement and observation system comprising a smartphone and a smartphone protective case, according to various embodiments. [Figure 2K] This figure shows a bitometric or physiological parameter measurement and observation system comprising a smartphone and a smartphone protective case, according to various embodiments. [Figure 3A] This figure shows a bytemetric or physiological parameter measurement and observation system comprising a tablet computer and a tablet computer protective case, according to various embodiments. [Figure 3B]This figure shows a bytemetric or physiological parameter measurement and observation system comprising a tablet computer and a tablet computer protective case, according to various embodiments. [Figure 3C] This figure shows a bytemetric or physiological parameter measurement and observation system comprising a tablet computer and a tablet computer protective case, according to various embodiments. [Figure 3D] This figure shows a bytemetric or physiological parameter measurement and observation system comprising a tablet computer and a tablet computer protective case, according to various embodiments. [Figure 3E] This figure shows a bytemetric or physiological parameter measurement and observation system comprising a tablet computer and a tablet computer protective case, according to various embodiments. [Figure 3F] This figure shows a bytemetric or physiological parameter measurement and observation system comprising a tablet computer and a tablet computer protective case, according to various embodiments. [Figure 4A] This figure shows a bytemetric or physiological parameter measurement and observation system comprising a keyboard and keyboard accessories for a computing device, according to various embodiments. [Figure 4B] This figure shows a bytemetric or physiological parameter measurement and observation system comprising a keyboard and keyboard accessories for a computing device, according to various embodiments. [Figure 4C] This figure shows a bytemetric or physiological parameter measurement and observation system comprising a keyboard and keyboard accessories for a computing device, according to various embodiments. [Figure 5A] This figure shows a bytemetric or physiological parameter measurement and observation system comprising a laptop or palmtop computer and sensor accessories, according to many embodiments. [Figure 5B] This figure shows a bytemetric or physiological parameter measurement and observation system comprising a laptop or palmtop computer and sensor accessories, according to many embodiments. [Figure 5C] This figure shows a bytemetric or physiological parameter measurement and observation system comprising a laptop or palmtop computer and sensor accessories, according to many embodiments. [Figure 6] This figure shows methods for measuring and observing bytemetric or physiological parameters according to various embodiments. [Figure 7] This is a diagram illustrating a standard electrode placement for taking a 12-lead ECG. [Figure 8] This diagram shows an example of electrode placement on the chest for taking a 12-lead ECG (indicating positioning for V6-V12). [Figure 9A] This is a front view of one variation of the apparatus described herein (in this example, a wireless mobile telecommunications device is shown as being inserted into the apparatus, which is configured as a case). [Figure 9B] Figure 9A is a left side view of the apparatus. [Figure 9C] Figure 9A is a rear view of the device. [Figure 9D] Figure 9A is a right side view of the apparatus. [Figure 10A] This is a front view of another variation of the apparatus described herein, which is shown as empty but is configured as a case adapted to hold a mobile telecommunications device. [Figure 10B] Figure 4A is a left side view of the apparatus (in this example, the (first) electrode of the leg is on the left side of the case). [Figure 10C] Figure 4A is a rear view of the device. [Figure 10D] Figure 4A is a right side view of the apparatus. [Figure 11A]This figure shows another variation of the apparatus as described herein, from a left side view (in this example, the (first) electrode of the leg is located on the edge between the rear and left side of the case). [Figure 11B] This figure shows another variation of the apparatus as described herein, viewed from the rear. [Figure 11C] This figure shows another variation of the apparatus as described herein, from a right side view. [Figure 12A] This figure shows another variation of the apparatus as described herein, from a left side view (in this example, the (first) electrode of the leg is on the rear and adjacent to the left side). [Figure 12B] This figure shows another variation of the apparatus as described herein, viewed from the rear. [Figure 12C] This figure shows another variation of the apparatus as described herein, from a right side view. [Figure 13A] This figure shows another variation of the apparatus as described herein, from a left side view (in this example, the (first) electrode of the leg is located on the edge between the rear and left side of the case). [Figure 13B] This figure shows another variation of the apparatus as described herein, viewed from the rear. [Figure 13C] This figure shows another variation of the apparatus as described herein, from a right side view. [Figure 14A] This figure shows another variation of the apparatus as described herein, from a left side view (in this example, the (first) electrode of the leg 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 rear). [Figure 14B] This figure shows another variation of the apparatus as described herein, viewed from the rear. [Figure 14C] This figure shows another variation of the apparatus as described herein, from a right side view. [Figure 15A]This figure shows another variation of the apparatus as described herein, from a left side view (in this example, the (first) electrode of the leg is located on the rear surface between the second and third electrodes). [Figure 15B] This figure shows another variation of the apparatus as described herein, viewed from the rear. [Figure 15C] This figure shows another variation of the apparatus as described herein, from a right side view. [Figure 16A] This figure shows another variation of the apparatus as described herein, from a front view (in this example, the (first) electrodes of the legs are on a cord that can be extended from the body of the device for attachment to the legs). [Figure 16B] This figure shows another variation of the apparatus as described herein, viewed from the rear. [Figure 17] This figure shows an application of one variation of the apparatus for detecting an ECG described herein, in which the patient's legs are held against the patient's legs so that the leg electrodes are in contact with the legs while the patient's hands are in contact with the left and right electrodes, respectively, at the back of the device. [Figure 18] This is a diagram illustrating the range and threshold of human hearing, from http: / / en.labs.wikimedia.org / wiki / Acoustics. [Figure 19] This is an illustration of age-related hearing loss from www.neuroreille.com / promenade / english / audiometry / audiometry.htm. [Figure 20] This is a general audiogram showing sound intensity and frequency, from www.hearinglossky.org / hlasurvivall.html. [Figure 21A] This is a schematic diagram of a system configured to transmit digital data encoding one or more biological parameters to a telecommunications device such as a smartphone using ultrasound. [Figure 21B]This is a schematic diagram of a system including a medical sensing device configured to transmit data encoding one or more biological parameters to a telecommunications device such as a smartphone using ultrasound. [Figure 21C] This is a schematic diagram of a system including a medical sensing device configured to transmit and receive data encoding one or more biological parameters (e.g., ECG data) to and from a telecommunications device such as a smartphone using ultrasound. [Figure 22] This figure shows one variation of a digital signal encoded using frequency shift modulation in the ultrasonic range, as described. [Figure 23] This is an illustrative flowchart showing one method of transmitting encoded data as an ultrasonic signal. [Figure 24A] This is an illustrative flowchart of a method for transmitting a signal as an ultrasonic signal (e.g., packet transmission). [Figure 24B] This is an illustrative flowchart of a method for transmitting a signal as an ultrasonic signal (e.g., packet transmission). [Figure 24C] This is an illustrative flowchart of a method for transmitting a signal as an ultrasonic signal (e.g., packet transmission). [Figure 24D] This is an illustrative flowchart of a method for transmitting a signal as an ultrasonic signal (e.g., packet transmission). [Figure 24E] This is an illustrative flowchart of a method for transmitting a signal as an ultrasonic signal (e.g., packet transmission). [Figure 25] This figure shows an example flowchart of a demodulator and packet decoder for a receiver configured to receive and decode data transmitted by ultrasound, as discussed herein. [Figure 26A] This figure shows one exemplary format of a hybrid digital and analog ultrasound data format. [Figure 26B]This figure shows another exemplary format of hybrid digital and analog ultrasound data formats. [Figure 27] This is a schematic diagram of a system for secure ultrasonic transmission of data, including an ultrasonic communication device with an ultrasonic transducer, an encryption key placed on the ultrasonic communication device, and decryption logic executable on a telecommunication device, the telecommunication device comprising a receiver for receiving ultrasonic signals from the ultrasonic communication device. [Figure 28A] This figure shows one variation of a wristret device for detecting one or more biological parameters and wirelessly transmitting them to a mobile communication / computing device at extremely low power (showing the outside of the wristret). [Figure 28B] This figure shows one variation of a wristret device for detecting one or more biological parameters and wirelessly transmitting them to a mobile communications / computing device at extremely low power (a schematic diagram of the inner region including various modules for sensing the power and transmission of ultrasonic signals is shown, many of which are optional). [Figure 29] This figure shows one variation of a wristlet configured as a watch for detecting ECG signals. [Figure 30] Figure 29 shows a listlet communicating (via ultrasound) with a mobile telecommunications device to transmit ECG information. [Figure 31] This is a flowchart of a method for performing a 12-lead ECG using a 3-electrode device according to some embodiments of the present disclosure. [Figure 32] This is a flowchart of a method for machine learning training of a 12-lead ECG using a 3-electrode device, according to some embodiments of the present disclosure. [Modes for carrying out the invention]

[0008] A device, system, and method for measuring and observing biometric or physiological parameters in a user-friendly and convenient manner are disclosed.

[0009] This disclosure is not limited to the configurations, experiments, illustrative data, and / or component arrangement details described below. Other embodiments of the inventions in this disclosure are possible, and they can be practiced or executed in various ways. Furthermore, terms used herein are for illustrative purposes only and should not be considered limiting.

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

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

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

[0013] Electrocardiogram (ECG) recording is used to examine 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 pairs of electrodes 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 1, 3, 5, and 12 leads. In a 12-lead ECG, 10 electrodes may be used: 6 on the patient's chest and one each on the arms and legs.

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

[0015] A standard or conventional 12-lead ECG configuration uses 10 electrodes. Figure 1 shows a pictorial representation of the 10 electrodes, with 6 electrodes on the patient's chest and one electrode on each of the patient's arms and legs. The electrode located on the right arm may be called the RA. The electrode located on the left arm may be called the LA. The RA and LA electrodes are positioned in the same location on the left and right arms, preferably near the wrist. The electrodes on the legs may be called the RL for the right leg and the LL for the left leg. The RL and LL electrodes are positioned in the same location on the left and right legs, preferably near the ankle.

[0016] In another embodiment, a 12-lead ECG may be generated using three electrodes (for example, by a device including three electrodes). For example, in one embodiment, a device having three electrodes as described herein may be used to simultaneously determine lead I (e.g., the voltage between the left and right arms) and lead II (e.g., the voltage between the left leg and right arm), and to simultaneously determine lead I with another 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 temporally align two sets of records using lead I or another lead common in the measurement, so that two sets of measurement results can be compared over the same simulated period.

[0017] The processing logic may further transform two sets of reads to generate a complete 12-lead ECG. In one embodiment, the processing logic may perform such a transformation using a machine learning model (e.g., a neural network, deep learning technique, etc.). The machine learning model may be trained using 12-lead ECG data corresponding to a population of individuals. The data may be preprocessed to filter the data in an application-appropriate manner 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 one or more models are fine-tuned according to a particular type of individual. In a further embodiment, the machine learning model may be further trained on the user's unique ECG data to fine-tune and personalize the model and further reduce any residual synthesis error.

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

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

[0020] Lead I is typically the voltage between the left arm (LA) and the right arm (RA), for example, I = LA - RA. Lead II is typically the voltage between the left leg (LL) and the right arm (RA), for example, II = LL - RA. Lead III is typically the voltage between the left leg (LL) and the left arm (LA), for example, III = LL - LA. Wilson's central electrode (WCT or VW) can be calculated as (RA + LA + LL) / 3. If both leads I and II are recorded relative to RA so that the voltage at RA can be considered 0, then 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. Errors or misalignments in electrode placement can alter the results of ECG in a 6-axis system.

[0023] However, current walkable electrocardiogram recording devices, such as Holter monitors, are typically bulky and difficult for subjects to attach without the assistance of a medical professional. For example, using a Holter monitor requires the patient to wear a large device on their chest and precisely position multiple electrodes in the correct location on the chest. These requirements can interfere with the subject's activities, including natural movement, bathing, and showering. Once a fully disclosed ECG is generated, it is sent to the patient's physician, who then analyzes the ECG and makes a diagnosis and other recommendations. Currently, this process often has to be carried out through hospital administrators and healthcare 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 telecommunication devices (e.g., smartphones) for use in recording ECGs. However, such devices either require the use of external (e.g., plug-in) electrodes or contain electrodes within a 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, body temperature, ECG, etc.) typically need to communicate wirelessly to an observation, analysis, or recording station ("observation station"). Typically, the transmission of information is carried out by short-wavelength wireless transmission (e.g., "Bluetooth"). While some embodiments are described in particular with respect to ultrasonic communication, it is considered that Bluetooth communication is at least equally applicable to the described techniques, and ultrasound is proposed merely as an unrestricted example of any number of other suitable communication techniques. Those skilled in the art would likely recognize this.

[0026] In some situations where it is desirable for the device to be lightweight so that it can be comfortably worn during normal daily activities or exercise, many manufacturers are choosing to record data rather than transmit it, and to periodically download the data by connecting directly 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 an observation device that can be worn on other areas of the body where reliable low-energy wireless transmission of data is possible.

[0027] For example, cardiac observation devices such as those described in U.S. Patents 4,221,223, 4,295,472, and 4,230,127 describe a wristwatch-sized wearable monitor that can detect ECG signals from a patient wearing the device. These signals may be displayed on the device; these signals are not transmitted. Other similar devices are described in U.S. Patent 4,938,228. U.S. Patents 5,351,695, 5,333,616, 5,317,269, and 5,289,824 (all Mils) describe improvements to this device, which include an integrated hearing-aid type speaker for transmitting ECG signals over a telephone line using sound on a telephone voice channel, using audible sound (e.g., between 1 kHz and 3 kHz). ECG signals are typically digitized and frequency-modulated (e.g., as a frequency-shift-modulated signal). Unfortunately, such devices are literally very noisy, require a lot of power to produce, generate, and transmit audible signals, and are not capable of two-way communication, especially with mobile telecommunications devices.

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

[0029] Ultrasonic transmission shares many similarities with electrical transmission, but also has considerable differences, including those previously considered disadvantages. Furthermore, while techniques such as frequency shift modulation are known for digitizing information, implementing such techniques on a timescale that makes them practical for use in medical (e.g., ECG) monitoring has been difficult and impractical. In particular, the transmission of ultrasound data has, to date, been somewhat limited in terms of the amount and content of information transmitted. For example, digital encoding of information via ultrasound has been limited in terms of the amount and content of information transmitted. There are also no standards yet for the transmission or encoding of ultrasound signals. Moreover, such ultrasound signals are not typically encrypted.

[0030] Therefore, it would be advantageous to provide systems, devices, and methods for encoding or organizing information transmitted by ultrasonic transmission. In particular, it would be advantageous to encode the information in a manner that avoids the limitations of ultrasonic transmission (rather than electromagnetic or audible transmission). 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 that transmits ECG information ultrasonically (e.g., a wristlet) with one or more receiving devices.

[0031] Methods, devices, and systems described herein are for receiving and transmitting information (including, but not limited to, digital health information) that is encoded by an application device into an ultrasonic signal that can be heard by a telecommunications device, and then stored, transmitted, and / or analyzed by a telecommunications device, using (or adapted for use) one or more widely available telecommunications devices (including mobile telecommunications devices), such as smartphones, tablet computers, portable computers, or desktop computers. In particular, methods, devices, and systems described herein are for encoding information so that only a telecommunications device provided with a key can interpret this information. Systems, devices, and methods (including executable logic) may include techniques for readily providing keys using a mode other than ultrasonic transmission (e.g., optical).

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

[0033] Therefore, improved devices, systems, and methods for managing and observing cardiac disease and / or rhythm are needed to address one or more of the above challenges.

[0034] Devices, systems, and methods are disclosed 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 system of this disclosure may enable the measurement of one or more of a user's physiological parameters while the user is normally operating a computing device such as a laptop, tablet computer, or smartphone. One or more physiological parameters may be measured using accessories for the computing device, such as a laptop case, tablet computer case, or smartphone case. Normal use of a computing device may include web browsing, reading and writing email or text messages, playing games, or using other common applications such as books or text readers. The physiological parameter observation and measurement application of this disclosure may operate in the background while the computing device is being normally used.

[0035] Aspects of this disclosure provide a system for measuring a user's cardiac parameters. The system may comprise a device configured to be coupled to a computing device and a first application loaded onto the computing device. The device may comprise a sensor for measuring cardiac parameters. The first application may be configured to receive cardiac parameters measured from the sensor. The sensor may measure cardiac parameters, and the first application may receive the measured cardiac parameters simultaneously with a second application being loaded onto the computing device and operated by the user.

[0036] Cardiac parameters may include one or more of the following: heart rate, heart rate variability, blood pressure, blood pressure variability, arrhythmia, oscillatory cardiomyogram (SCG), SCG parameters, electrocardiogram (ECG), or ECG parameters. In many embodiments, cardiac parameters include an electrocardiogram (ECG) or ECG parameters.

[0037] A computing device may comprise one or more of the following: 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 device may be configured to be detachably coupled to the computing device and may include a cover for enclosing the computing device, such as a tablet computer case or a smartphone case or cover.

[0038] A sensor for measuring cardiac parameters may comprise first and second electrodes configured to generate a signal containing cardiac parameters upon contact with a user. 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. The sensor may further comprise a third electrode for contact configured to generate a signal containing cardiac parameters upon contact with a user. The first, second, and third electrodes may be used simultaneously to generate one or more of the lead I, lead II, or lead III ECGs, for example. 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 further be configured to display the measured cardiac parameters, for example, on the display of a computing device. The cardiac parameters may be displayed in real time. The first application may further be configured to store the measured cardiac parameters in the memory of the computing device. The first application may further be configured to transmit 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 allow access to such data by medical professionals and other experts 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 a medical professional or expert may automatically generate the analysis, interpretation, and / or diagnosis of such data.

[0040] Operation of the second application may include one or more of the following: typing on the keyboard of the second application, scrolling on the second application, zooming in or out on the second application, or entering data into the second application in a different way. By enabling 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, embodiments of the present disclosure enable user-friendly, convenient, less invasive and less cumbersome measurement and observation of cardiac and other health parameters. For example, while the first application and the computing device cover measure and / or observe the user's ECG or other cardiac and physiological parameters in the background, the user can hold the computing device and operate it normally, check email, browse the web, or operate a mobile application.

[0041] Aspects of this disclosure also provide a method for measuring a user's cardiac parameters. An apparatus comprising sensors for cardiac parameters may be coupled to a computing device. The user's cardiac parameters may be measured using the sensors. The measured cardiac parameters may be transmitted using the apparatus to a first application loaded onto the computing device. The cardiac parameters may be measured simultaneously with the user's operation of a second application loaded onto the computing device, and the first application may receive the transmitted measured cardiac parameters.

[0042] Cardiac parameters may include one or more of the following: heart rate, heart rate variability, blood pressure, blood pressure variability, arrhythmia, oscillatory cardiac graph (SCG), SCG parameters, electrocardiogram (ECG), or ECG parameters. In many embodiments, cardiac parameters include an electrocardiogram (ECG) or ECG parameters.

[0043] A computing device may comprise one or more of the following: 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. An apparatus may be coupled to a computing device by detachably attaching the apparatus to the computing device. For example, the apparatus may comprise a cover for enclosing the computing device, such as a tablet computer case or a smartphone cover. Alternatively, the method may comprise enclosing a computing device, such as a tablet computer or a smartphone, at least partially with a case or cover.

[0044] Cardiac parameters can be measured using a sensor by measuring cardiac parameters at first and second electrodes of the sensor. The first and second electrodes may be configured to generate a signal containing cardiac parameters when in contact with the user. 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. Cardiac parameters may also be measured using a third electrode of the sensor, which is configured to generate a signal containing cardiac parameters when in contact with the user. The first, second, and third electrodes may be used simultaneously to generate one or more of the lead I, lead II, or lead III ECGs, for example. 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] Furthermore, the received measured cardiac parameters may be displayed on the computing device's display. The cardiac parameters may be displayed in real time. The measured cardiac parameters may also be stored in the computing device's memory. 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 medical professionals and other experts to access such data for analysis, interpretation, and / or diagnosis. 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 following may be used: a first application loaded on the computing device, another application loaded on the remote server, or another application used by a medical professional or expert, which may automatically generate the analysis, interpretation, and / or diagnosis of such data.

[0046] Operation of the second application may include one or more of the following: typing on the keyboard of the second application, scrolling on the second application, zooming in or out on the second application, or inputting data into the second application in a different way. By enabling 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, embodiments of the present disclosure enable user-friendly, convenient, less invasive and less cumbersome measurement and observation of cardiac and other health parameters. For example, while the first application and the computing device cover measure and / or observe the user's ECG or other cardiac and physiological parameters in the background, the user can hold the computing device and operate it normally to check email, browse the web, or operate a mobile application. In some embodiments, the first application may cause the computing device to alert the user (i.e., a pop-up may appear in the second application) if the health parameter sensor is mispositioned and therefore cannot, or should not be able to, perform a proper measurement.

[0047] Aspects of this disclosure also provide a system for measuring a user's cardiac parameters. The system may include a cover configured to be detachably attached to a portable computing device. The portable computing device may have a front, a back, and a rim between the front and back. The cover may include a plurality of sensor electrodes configured for measuring cardiac parameters and disposed on the rim 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 rim 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] Cardiac parameters may include one or more of the following: heart rate, heart rate variability, blood pressure, blood pressure variability, arrhythmia, oscillatory cardiac graph (SCG), SCG parameters, electrocardiogram (ECG), or ECG parameters. In many embodiments, cardiac parameters include an electrocardiogram (ECG) or ECG parameters.

[0049] The multiple sensor electrodes may comprise a first sensor electrode and a second sensor electrode. The first and second sensor electrodes may be configured to generate a signal containing cardiac parameters when in contact with a first and second limb of the user, respectively. 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 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 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 lead III ECG. The multiple sensor electrodes may further comprise a third sensor electrode configured to generate a signal containing cardiac parameters when in contact with a third limb of the user. Cardiac parameters may also be measured using a third electrode of the sensor, which is configured to generate a signal containing cardiac parameters when in contact with the user. The first, second, and third electrodes may be used simultaneously to generate one or more of the following ECGs, for example, lead I, lead II, or lead III.

[0050] The system may further include a first application loaded onto a portable computing device. The first application may be configured to receive cardiac parameters measured from multiple sensor electrodes. The first application may receive the measured cardiac parameters simultaneously with a second application loaded onto the portable computing device and operated by the user. Operation of the second application may include one or more of the following: typing on the keyboard of the second application, scrolling on the second application, zooming in or out on the second application, or inputting data into the second application in a different way. By enabling the user to operate the second application loaded onto the computing device while the first application measures and observes the user's cardiac parameters and other health parameters, embodiments of the present disclosure enable user-friendly, convenient, less invasive and less cumbersome measurement and observation of cardiac parameters and other health parameters. For example, while the first application and the computing device cover measure and / or observe the user's ECG or other cardiac and physiological parameters in the background, the user can hold the computing device and operate it normally, check email, browse the web, or operate a mobile application.

[0051] The first application may be configured to display received cardiac parameters on the display of a portable computing device. The received cardiac parameters may be displayed in real time. The first application may further be configured to store the measured cardiac parameters in the memory of the portable computing device. The first application may further be 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 allow access to such data by medical professionals and other experts 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 a medical professional or expert may automatically generate the analysis, interpretation, and / or diagnosis of such data.

[0052] Aspects of this disclosure also provide a method for measuring a user's cardiac parameters. A cover may be detachably attached to a portable computing device. The portable computing device may have a front, a back, and a rim between the front and back. First and second electrodes of the cover may contact the user's first and second limbs to generate signals comprising cardiac parameters, respectively. The first and second electrodes of the cover may be arranged on the rim of the portable computing device. In many embodiments, multiple sensor electrodes may be arranged only on the rim 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] Cardiac parameters may include one or more of the following: heart rate, heart rate variability, blood pressure, blood pressure variability, arrhythmia, oscillatory cardiac graph (SCG), SCG parameters, electrocardiogram (ECG), or ECG parameters. In many embodiments, cardiac parameters include an electrocardiogram (ECG) or ECG parameters.

[0054] A third electrode may contact the user's third limb to generate a signal containing cardiac parameters. The first limb may be the right arm, the second limb may be the left arm, and the third limb may be the left leg. These three limbs may contact the first, second, and third electrodes simultaneously to generate lead I ECG, lead II ECG, and lead III ECG, respectively. Alternatively, the first and second electrodes may be used to generate lead I ECG, lead II ECG, and 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 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 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. Alternatively, or in combination,

[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 multiple sensor electrodes. The first application may receive the measured cardiac parameters simultaneously with the second application being loaded onto a computing device and operated by the user. Operation of the second application may include one or more of the following: typing on the keyboard of the second application, scrolling on the second application, zooming in or out on the second application, or inputting data into the second application in a different way. By enabling the user to operate the second application loaded onto the computing device while the first application measures and observes the user's cardiac parameters and other health parameters, embodiments of the present disclosure enable user-friendly, convenient, less invasive and less cumbersome measurement and observation of cardiac parameters and other health parameters. For example, while the first application and the computing device cover measure and / or observe the user's ECG or other cardiac and physiological parameters in the background, the user can hold the computing device and operate it normally, checking email, browsing the web, or operating a mobile application.

[0056] The received cardiac parameters may be displayed on the display of a tablet computer or smartphone using a first application. The received cardiac parameters may be displayed in real time. The measured cardiac parameters may be stored in the 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 experts for analysis, interpretation, and / or diagnosis. 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 a medical professional or expert may automatically generate the analysis, interpretation, and / or diagnosis of such data.

[0057] Aspects of this disclosure also provide a system for measuring a user's cardiac parameters. The system may comprise a sensor device and an application. The device may be configured to be attached to the keyboard of a computing device, the steering wheel of a motor-driven vehicle, or the handlebars of an exercise machine such as a bicycle, bike, treadmill or elliptical machine or weightlifting machine, as well as a seat, chair, glasses, clothing, etc. The device may comprise a sensor for measuring cardiac parameters. The device may be configured to receive cardiac parameters measured from the sensor when the keyboard of a computing device, the steering wheel of a motor-driven vehicle, or the handlebars of a bicycle, bike, or exercise machine is touched, held, or operated. Further methods and systems are also conceived for convenient, non-invasive, and unobtrusive measurement and observation of cardiac parameters and other physiological parameters while the user is normally operating a computing device or other device that is in contact with the user's body.

[0058] This disclosure also describes apparatus and methods (including methods for using these apparatus) for obtaining electrocardiogram (ECG) information from a subject using a mobile telecommunications device having three electrodes and an interface compatible with it. Apparatus for detecting ECGs that can address, but are not limited to, the problems identified above, using currently available ECG detection systems, are described herein.

[0059] In general, the apparatus (including devices and systems) and methods described herein are for use in detecting biological signals such as electrocardiograms (ECGs). In particular, apparatus for use with mobile telecommunications devices is described herein so that the mobile telecommunications device can 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 the mobile telecommunications device or to connect directly to the mobile telecommunications device. One or more electrodes may be positioned directly on the outer surface of the housing. The apparatus may also include one or more transmitters for the detected communication signal, including a modified / processed version of the detected signal, from the electrodes to the mobile telecommunications device. The mobile telecommunications device may be connected to the housing and, for example, located inside or near the case formed by the housing. In some variations, the apparatus may include one or more processing devices for processing the signals detected by the electrodes.

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

[0061] The apparatus described herein may be configured to be held by the patient with both hands against the patient's leg (e.g., left or right leg) to measure six of the patient's “leads” (leads I–III, and amplified leads aVR, aVL, aVF). In some variations, the apparatus may be configured so that the patient can easily view the screen of the mobile telecommunications device while holding the apparatus (surrounding the mobile telecommunications device) with both hands against the leg (right or left) and 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 apparatus, including guidance (using the screen or audio output of the mobile telecommunications device) to adjust or correct electrode contact or placement and / or to display one or more ECG signals as measurements are taken. Thus, the apparatus may be easily held to allow electrically separate measurements from each arm (right, left) and leg (left or right), and still be configured as described herein so that the subject holding the device can observe the screen of a mobile telecommunications device coupled to the device.

[0062] In general, the patient (as used herein) may be a human patient or, but is not limited to, a non-human patient including animals (such as dogs, cats, or horses). Accordingly, any apparatus or method described herein may be used for veterinary applications or may be configured as a veterinary product.

[0063] Generally, mobile telecommunications devices may include any mobile telecommunications device, such as a mobile (e.g., cellular) phone or equivalent, including, but not limited to, iPhone®, Droid®, etc. Mobile telecommunications devices may include processing devices or other computing modules / devices that may surround software, hardware, etc., including machine-readable code configured to operate the device to receive and / or transmit information from the device described herein. Such code may be provided with or separately from the device described. Mobile telecommunications devices may be (and include) referred to as cell phones or cellular phones or cell telephones or cellular telephones, mobile phones or mobile telephones, smartphones, handheld computers, tablets, wearable computers, etc. Code may be referred to as software or application software ("apps" or "applications") and may be downloaded to a mobile telecommunications device from a remote location.

[0064] For example, an electrocardiogram (ECG) detection device for use with a wireless telecommunications device is described herein. In some variations, the device includes a case configured to cover and fit a telecommunications device, having an outer back, at least two outer sides perpendicular to the back, and a front region through which the screen of the telecommunications device held inside 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 having an outer contact surface; and a third electrode on the outer back having an outer contact surface, wherein the outer contact surfaces of the second and third electrodes are recessed with respect to at least a portion of the outer back so that when the case is placed on a table surface with the outer back facing the table surface, the outer contact surfaces of the second and third electrodes do not come into contact with the table surface; and further, the second and third electrodes are arranged so that the 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 also view the screen of the telecommunications device held inside 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 a mobile telecommunications device within a cavity, or otherwise to cover and cover the mobile telecommunications device. Thus, the case may include an inner 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 cutout area or a transparent cover through which the mobile telecommunications device can be viewed. Electrodes may be mounted on the case. The case may also include one or more other openings for accessing control, input, output, or connection areas of the mobile telecommunications device (e.g., jacks, plug-in receptacles, etc.). Generally, electrodes are arranged on the case so that (1) the electrodes are protected from contact with surfaces, especially metal surfaces, when the device is not in use, and (2) a patient holding the device against their leg to record simultaneously from both arms (via hands) and legs can easily access the electrodes while viewing the screen. The case may also house additional components such as the transmitter mentioned above, a power supply (e.g., a battery, solar cell, etc.), and / or processing devices or other circuits for adjusting, amplifying, filtering, or otherwise modifying the signals received by the electrodes. In some variations, the device may be configured such that one of the electrodes (e.g., a second or third electrode) can act as a reference electrode to the other two (or possibly more) electrodes.

[0066] In a variation in which the case may include one or more mounting areas for one or more electrodes, for example, it may include an opening on the back for interface with electrode units that can 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 supply or other electronic components.

[0067] The second and third electrodes are typically configured to be easily accessible to each of the patient's hands. For example, the position and size of the second electrode may be determined so that the patient can touch the second electrode with their left hand while also touching the third electrode, which is of appropriate shape and size, with their right hand. For example, in some variations, the second and third electrodes are located entirely on the outer back. The second electrode may be on the upper / left half of the back of the case (relative to the mobile telecommunications device), while the third electrode is located on the lower / right half of the back of the case. The second and third electrodes may be separated by a gap of size and / or shape that prevents overlapping contact with the left and right hands. In general, the patient should only touch each electrode with one hand.

[0068] The second and third electrodes may be formed from any suitable conductive material (including metals, alloys, etc.) and may be sized to be easily accessible by one or more fingers (or palm) of a patient holding the device. In some variations, the second and third electrodes are positioned symmetrically with respect to each other from the center of the outer back surface.

[0069] The first electrode may be configured so that it 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 positioned entirely to the side of the case (for example, on one of at least two outer sides). Alternatively, the first electrode may be located on the back of the case, but extending along the edge, so 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 located on the back, but in contact with or immediately adjacent to a side (at least one of two outer sides). In some variations, the first electrode curves along the edge of the case, for example, from the back to the side, covering the edge of the case. Thus, the first electrode may extend covering 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 a certain angle relative to the patient's leg, so that the patient can hold the case with both hands, touch the second and third electrodes, and maintain good contact with the leg while viewing the screen of the mobile telecommunications device.

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

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

[0072] Generally, the device may be configured such that the electrodes (first and / or second and third) do not come into contact with the table surface when the device is placed on a table with the electrodes facing the table. 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 power leakage from the device). In some variations, the electrodes are recessed to the outer back surface. For example, the electrodes may be embedded within the material forming the case. Alternatively, or additionally, the case may include one or more protrusions that can support the case when placed with its back facing down, preventing one or more electrodes from coming into contact with 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 to the outer surfaces of one or more “spacers”. Generally, 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, spacers can be bumps, islands, bars, pieces, tabs, etc., extending from the back, or in some variations surrounding the electrodes (e.g., all or part of them encircling the electrodes).

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

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

[0075] For example, an electromagnetic (ECG) detection device for use with a wireless telecommunications device is described herein, the device comprising: a case configured to cover and fit a telecommunications device, having an outer rear, at least two outer sides perpendicular to the rear, and a front area through which the screen of a telecommunications device held inside 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 rear having an outer contact surface; a third electrode on the outer rear having an outer contact surface; and an ultrasonic transmitter configured to ultrasonically transmit signals detected from the first, second, and third electrodes to a wireless telecommunications device, wherein the outer contact surfaces of the second and third electrodes are recessed with respect to at least a portion of the outer rear so that the outer contact surfaces of the second and third electrodes do not come into contact with the table surface when the case is placed on a table surface with the outer rear 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 the 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 his leg, while simultaneously touching a second electrode at the rear of the case with his right hand and a third electrode at the rear of the case with his left hand, so that the patient does not come into contact with 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] A method for generating an electrocardiogram (ECG) from a patient using a handheld wireless telecommunications device case having three electrodes on the outer surface of the case is also described herein, the method comprising the steps of: instructing the patient to hold the first electrode of the case against their leg, while simultaneously touching the second electrode with their right hand and the third electrode with their left hand, so as not to 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; detecting a third lead signal (lead III) of the ECG between the first electrode and the third electrode; and transmitting the lead signals from the case to a telecommunications device using ultrasound.

[0078] Aspects of the present disclosure also provide an electrocardiogram (ECG) detection device for use with a wireless telecommunications device. The device may comprise a case configured to cover and fit the telecommunications device. The case may have an outer rear, at least two outer sides perpendicular to the rear, and a front region through which the screen of the telecommunications device held inside the case can be viewed. The device may further comprise a first electrode located on or adjacent to one of the at least two outer sides, a second electrode located on the outer rear and having an outer contact surface, and a third electrode located on the outer rear and having an outer contact surface. The outer contact surfaces of the second and third electrodes may be recessed with respect to at least a portion of the outer rear so that the outer contact surfaces of the second and third electrodes do not come into contact with the table surface when the case is placed on a table surface with the outer rear facing the table surface. Furthermore, the second and third electrodes can be arranged so that the patient can touch the outer contact surface of the second electrode with only their left hand and the outer contact surface of the third electrode with only their right hand, and can also view the screen of a telecommunications device held in a case while holding the first electrode against their leg.

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

[0080] The device may have as few as three electrodes on the outer surface of the case. The outer rear surface of the case may have one or more spacers configured to extend a portion of the outer rear 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 one or more spacers.

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

[0082] Aspects of the present disclosure also provide an electrocardiogram (ECG) detection device for use with a wireless telecommunications device. The device may comprise a case configured to cover and fit the telecommunications device. The case may have an outer rear, at least two outer sides perpendicular to the rear, and a front region through which the screen of the telecommunications device held inside the case can be viewed. The device may further comprise a first electrode on or adjacent to one of the at least two outer sides, a second electrode on the outer rear having an outer contact surface, a third electrode on the outer rear having an outer contact surface, and an ultrasonic transmitter configured to wirelessly (e.g., by ultrasound) transmit signals detected by the first, second, and third electrodes to a wireless telecommunications device. The outer contact surfaces of the second and third electrodes may be recessed with respect to at least a portion of the outer rear so that the outer contact surfaces of the second and third electrodes do not come into contact with the table surface when the case is placed on a table surface with the outer rear facing the table surface.

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

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

[0085] A wearable wristlet device capable of reliably and conveniently transmitting information recorded from a user (e.g., ECG information) using ultrasound is also described herein. An observation station is also described, including control logic for configuring and operating a mobile computing / telecommunications device as an observation station capable of securely and reliably receiving this ultrasound data.

[0086] Devices, systems, and methods for transmitting digital and / or analog data ultrasonically from (and possibly to) a wearable (e.g., wristlet) device having one or more sensors, a microprocessor, and a transducer (i.e., a piezoelectric speaker) capable of delivering ultrasonic frequencies. 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.), the microphone having the capability to receive audio in the ultrasonic frequency range (e.g., above 17 kHz, above 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 will be described in more detail below. In addition, the information may be compressed (data compression) before encryption.

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

[0088] The protocols and logic of ultrasonic digital modems and digital modems for securely transmitting digital information ultrasonically from wearable devices such as wristlets to remote communication devices configured as receivers are also described herein.

[0089] This specification describes a wristlet device that includes one or more sensors for detecting 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 any combination thereof) that enables the device to drive ultrasonic transmission of data from a speaker (e.g., a piezoelectric speaker element). Methods for configuring or adapting a microcontroller to operate as an ultrasonic modem are also described. For example, in some variations, a microcontroller can be programmed to operate as an ultrasonic modem. The ultrasonic modem can be configured to format the information to be transmitted as a hybrid digital and analog format. In some variations, the ultrasonic modem can be an ultrasonic modem component that encrypts the information using an encryption key.

[0090] Receivers configured to receive ultrasonic digital data acoustically transmitted by an ultrasonic digital modem are also described herein. In general, telecommunications devices (e.g., smartphones) may be configured to operate as receivers for receiving ultrasonic digital data. Thus, telecommunications devices may include hardware, software, and / or firmware configured to receive, decode, interpret, display, analyze, store, and / or transmit data transmitted by ultrasonic transmission from a digital ultrasonic modem. In some variations, logic (e.g., client software and / or firmware, applications, etc.) may be executed on the telecommunications device so that the telecommunications device can operate as a receiver for digital ultrasonic data. Thus, devices including executable logic for receiving and interpreting (e.g., decode) data transmitted by a digital ultrasonic modem, and executable logic for receiving and interpreting (e.g., decode) data transmitted by the digital ultrasonic modem executable logic are described herein.

[0091] Specific devices and systems configured to include a digital ultrasonic modem are described further herein. Any of these devices may include a source of digital information (e.g., a medical sensor or device (e.g., a thermometer, 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., for emitting a buzzer or beep, etc., within the normal hearing range of a person) and ultrasonic frequencies (e.g., higher than 17 kHz).

[0092] In one example, as described herein, a Texas Instruments AFE4110 digital thermometer is modified to encode body temperature data and transmit it ultrasonically to a telecommunications device (e.g., a smartphone) located at a distance from the thermometer. The device's microcontroller (Texas Instruments' MSP430 type controller) is configured to include an ultrasonic modem for transmitting ultrasonic digital data by encoding a data signal (via a microprocessor) for transmission over a connected piezoelectric speaker. The speaker may be the same speaker built into the thermometer and may be used to inform the user (e.g., within the normal range of human hearing) that the body temperature is stable. Thus, the thermometer can be modified to include a digital ultrasonic modem at very low cost by executing control logic within the microcontroller to process data from the thermometer and transmit the encoded signal over 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 the 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 telecommunications devices (e.g., smartphones) where further processing and / or transmission of information can take place. Executable logic, also called an adapter, adapts the medical sensing device so that it can transmit biological parameter information ultrasoundly to the telecommunications device for further processing. Systems and / or subsystems for use with telecommunications devices are also described so that the telecommunications device can receive and convert health metrics information signals encoded ultrasoundly. These subsystems may include client software (e.g., an application) that will run on the telecommunications device (e.g., a telephone) to convert the ultrasound health information (or biological parameter) signals into digital signals that can be uploaded, stored, and / or analyzed by the telecommunications device.

[0094] A medical sensing device can be any device for receiving biological parameters such as a patient's vital signs. Biological parameters can also be called biometric data. For example, medical sensing devices may include thermometers, blood pressure transducers, glucose monitors, pulse oximeters, heart rate monitors, pedometers, activity monitors, and hydration monitors. The medical sensing devices or systems referred to herein are typically digital systems, as they can display a numerical (e.g., digital) representation of biological parameters. For example, a device can convert analog biological parameters (e.g., body temperature, blood glucose, blood pressure, or any other health metric information) into digital signals that can be displayed to or otherwise presented to a user. For example, a medical sensing system may include a digital thermometer for measuring a subject's body temperature, a cuff for displaying a patient's blood pressure, a blood glucose monitor, a pulse oximeter, and combinations of these devices. Of particular interest are home-use medical sensing systems or devices, in particular those having sensors to observe or collect biological parameters from a patient and presenting the information on a display.

[0095] As will be explained in more detail below, in some variations, devices and systems format and / or encode information so that the information contains a hybrid of both digital (e.g., extracted and / or alphanumeric) and analog (e.g., graphical) information. As used herein, the term “analog” refers to information that can be displayed graphically to show change or trend in sequence. Analog information can refer to a variable physical level that is quantifiable (e.g., a variable that changes over time). Actual information can be digital (e.g., by converting from continuous to discrete values), but may still be referred to herein as “analog” because it represents a change, distance, or some other variation of one or more parameters over time.

[0096] Any information transmitted as an ultrasound signal (e.g., analog, digital, hybrid digital / analog, etc.) can be encrypted. For example, information can be encrypted using an encryption key. The encryption key may be displayed on the device transmitting the ultrasound signal, or otherwise made available on the device, or made available by the device. Generally, the encryption key may be entered into a telecommunications device, which may then pair with a device including an ultrasound modem to receive and decrypt the information. Data encryption can enable the protection of information that requires careful handling by patients. Encryption can also reduce system noise by limiting the received signal to what is appropriately encoded.

[0097] As used herein, biological parameters or information may include any patient information processed, detected, and / or calculated by a medical sensing system, in particular digitally encoded biological parameters. For example, biological parameters may include body temperature, blood pressure, blood glucose levels, pH, oxygen saturation, heart rate, respiratory rate, or any other biological measurement results, in particular those related to a case, including diagnosis and health monitoring.

[0098] As used herein, a telecommunications 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 including (or which may be adapted to include) a microphone capable of receiving ultrasonic sound. A telecommunications device may include logic for converting digital signals encoded by ultrasonic sound into digital signals that can be displayed, uploaded / transmitted, stored, and / or analyzed.

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

[0100] For example, a sensor could be a transducer for converting biological parameters (e.g., a body temperature sensor, a pressure sensor). The device may also include a controller (e.g., a microcontroller) for processing signals from the sensor. The processing device may include a signal generator that produces a signal from the biological parameter information of the detected and / or processed patient, 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, an information bit that identifies the type or source of the biological parameter (e.g., a packet identifier), 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 timestamp and / or datestamp.

[0101] As mentioned, in some variations, the system may be configured to encrypt information and transmit only encrypted information. The telecommunications device may be configured to receive the encryption key directly (for example, by capturing and / or analyzing the numbers describing the encryption key).

[0102] In some variations, the system or device may be configured such that a measurement is taken at time x, stored in the device (e.g., a thermometer, blood glucose meter, etc.), and later transmitted ultrasonically to a telecommunications device (e.g., a smartphone or tablet), and finally uploaded (e.g., to the cloud). In some variations, several timestamped / datestamped measurement results may be recorded in the device and transmitted together in bursts to the telecommunications device. As will be explained in more detail below, the device may be primarily unidirectional in some variations (e.g., transmitting data from a biometric device to a telecommunications device), and the device may be configured to receive at least an acknowledgment signal and / or indicator that it is near the telecommunications device. In some variations, the ultrasonic transducer may also be configured to receive an acknowledgment signal from the telecommunications device. The acknowledgment may indicate that the telecommunications device has received the transmitted message (data), or that the telecommunications device is ready to receive the transmitted data, or both.

[0103] An ultrasonic transducer can be any suitable transducer, including a piezoelectric quartz transducer.

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

[0105] Processing devices can convert part or all of a digital biological parameter signal (typically numerical) into an ultrasonic signal using any suitable signal processing technique, including, but not limited to, frequency shift modulation.

[0106] Client control logic can be software or a client application (it may be software, hardware, firmware, etc.). Client control logic can run on a telecommunications device. Client control logic may also include components for passing digital representations of biological parameters to other devices, for example, for uploading them to a website or server. In some variations, client control logic may be configured to display or otherwise present information locally on the telecommunications device.

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

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

[0109] Generally, digital ultrasonic modem devices for securely transmitting digital data by ultrasound are described herein. Such devices may include a microprocessor, an ultrasonic transducer, an encryption key located on the device, and ultrasonic transmission logic that constitutes the digital data for acoustic transmission by the ultrasonic transducer at a frequency of 17 kHz or higher, wherein the ultrasonic transmission logic is further configured to encrypt the digital data according to the encryption key.

[0110] Any suitable ultrasonic transducer may be used. For example, an ultrasonic transducer could be a piezoelectric speaker. As mentioned, the encryption key may be inscribed on the device and may consist of alphanumeric codes, symbols, etc. For example, the encryption key may consist of a barcode, a QR code (registered trademark), 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 comprising an ultrasonic transducer, an encryption key located on the ultrasonic communication device, and an ultrasonic transmission logic comprising an ultrasonic transmission logic comprising an ultrasonic communication device comprising an ultrasonic transducer, an encryption key located on the ultrasonic communication device, and an ultrasonic transmission logic comprising an ultrasonic transmission logic comprising an ultrasonic transmission logic comprising an ultrasonic transmission logic comprising an ultrasonic transmission logic comprising an ultrasonic transmission logic comprising an ultrasonic transmission logic comprising an ultrasonic transmission logic comprising an ultrasonic transmission logic comprising an ultrasonic transmission logic comprising an ultrasonic transmission logic comprising a receiver for receiving ultrasonic signals from the ultrasonic communication device, and the decryption logic comprising receiving an encryption key and decrypting ultrasonic signals by applying the encryption key.

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

[0113] In any of the variations described herein, the telecommunication device may include an input for inputting 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 the encryption key may be determined from the image. In some variations, the input includes a manual input (e.g., a keypad, touchscreen, 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 the steps of receiving an encryption key present on the outer 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, the step of receiving the encryption key may include the step of obtaining the encryption key from the outer surface of the ultrasonic communication device. The step of decrypting the ultrasonic signal may include the step of decrypting the ultrasonic signal in the telecommunication device. As mentioned, the step of receiving the encryption key may include the step of photographing the encryption key using the camera of the telecommunication device.

[0116] In general, any of the systems described herein may use hybrid digital and analog coding. For example, a device for transmitting both digital and analog ultrasonic data (hybrid digital and analog data) may include a microprocessor, an ultrasonic transducer, and hybrid transmission logic configured to generate a signal having digital data appended to analog data for acoustic transmission by the ultrasonic transducer at frequencies of 17 kHz or higher.

[0117] As mentioned above, information can be encoded using frequency-shifted modulation (FSK). FSK digital data can 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 sensors for detecting biological parameters from the patient and / or a microprocessor configured to extract digital data from analog data. In some variations, the digital data includes calibration data for the analog data (e.g., minimum, maximum, variable intervals (e.g., time intervals), scale, etc.). The analog data may include any suitable signals typically measured from the device sensors, such as EEG, subject body temperature over time, subject glucose levels over time, subject blood pressure over time, subject oxygen levels over time, or subject physical activity over time.

[0119] Methods for transmitting hybrid digital and analog signals using ultrasound are also described herein. For example, a method may include the steps of generating an ultrasonic signal comprising digital data encoded using frequency-shifted modulation (FSK) to be added to an analog signal comprising a frequency-modulated signal modulated at a frequency higher than 17 kHz, and transmitting the signal acoustically using an ultrasonic transducer.

[0120] The method may also include a step of detecting biological parameters from the patient, and the analog signal may comprise these biological parameters. The method may also include a step of extracting digital data from the analog signal. The analog signal may comprise an EEG, the subject's body temperature over time, the subject's glucose levels over time, the subject's blood pressure over time, the subject's oxygen levels over time, or the subject's physical activity over time.

[0121] In some variations, the method also includes the step of 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 before transmission. Any of the variations described herein may be encoded using error correction codes. The method may also include a step of retransmitting the ultrasonic signal, 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 telecommunications device containing executable logic for receiving and / or decoding the ultrasonic signal. Thus, in some variations, the telecommunications device may be configured to return the signal to the ultrasonic communication device. The ultrasonic communication device may include a receiver, or it may be adapted to receive the signal with a transmitter (e.g., a piezoelectric element).

[0123] ECG detection listlets configured to transmit ECG information to a mobile telecommunications device or multiple devices are also described herein.

[0124] For example, a wireless wearable wristlet device for acquiring an electrocardiogram (ECG) signal from a subject wearing such a device and transmitting this information ultrasonically to a mobile telecommunications device is described herein. The wristlet device may include a wristlet body configured to fit the wrist, two or more electrodes for detecting an ECG signal from a subject, an ultrasonic transducer, and a processing device coupled to the ultrasonic transducer and configured to receive ECG signals from the two or more electrodes and encode the signals so that they are transmitted as ultrasonic signals for transmission by the ultrasonic transducer at a frequency higher than approximately 17 kHz.

[0125] The wristlet itself can be configured as a strap (e.g., the strap of any type of watch), a band, a bracelet, etc. In some variations, the wristlet includes a “front” area that can be worn on the subject’s wrist facing upwards. The wristlet may include a pair (or more than two electrodes). For example, in some variations, the wristlet includes an internal electrode that faces the wearer’s wrist when the wristlet is worn, so that the internal electrode can be sure to make contact with the wearer’s skin when worn. A second electrode may be positioned on the front or side of the wristlet. This second electrode may be configured to allow the wearer to touch the wristlet with their opposite hand / arm. In some variations, a third electrode may be positioned 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 their 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 frequencies between approximately 17 kHz and approximately 30 kHz (or any other range as defined herein, including higher than 16 kHz, higher than 17 kHz, higher than 18 kHz, etc.). Generally, the processing device may be configured to encode a signal to be transmitted as a hybrid signal, comprising digital information to be added to an analog signal.

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

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

[0129] In general, the devices described herein may be configured to operate in real time. Specifically, ECG information may be received and transmitted in real time. Mobile telecommunications devices 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 wristret device can be configured without a display or output, with only an audible output (e.g., a beep, a tone), or with only an LED (e.g., a simple indicator light). Alternatively, the device may rely on communication with a base station, such as a mobile telecommunications device, to display and, in some cases, analyze signals. For example, the device may include an indicator showing when it is communicating with a mobile telecommunications device. Thus, a wristret device without a display for showing ECG information can be smaller, lighter, and cheaper to manufacture and operate.

[0131] Furthermore, in some variations, the device may be configured to store most of the data, such as ECG data, and transmit it when a receiver, such as a mobile phone, is ready to receive it. Thus, any of these variations may include additional information, such as timestamps / datestamps and user input data. Thus, in some variations, the device further includes memory, which is coupled to a processing device and configured to store encoded signals 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 (for example, a processing device) may also be configured to determine when a mobile telecommunications device received an encoded signal from the device.

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

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

[0136] As described herein, hybrid ultrasonic signals may be configured to encode digital information using frequency-shifted modulation (FSK) and to append the FSK digital signal to an analog signal that is frequency-modulated but not encoded by FSK. For example, a processing device may be configured to extract digital information from an ECG signal. In some variations, the digital information includes calibration data for the analog signal. The processing device may be configured to encode a signal to be transmitted as an ultrasonic signal for transmission by an ultrasonic transducer at any suitable ultrasonic frequency (e.g., a frequency beyond the normal audible range), such as frequencies between approximately 17 kHz and approximately 30 kHz, as described herein.

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

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

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

[0140] The processing device may be configured to encode a signal to be transmitted as an ultrasonic signal for transmission by an ultrasonic transducer at frequencies between approximately 17 kHz and approximately 30 kHz. The processing device may be configured to encode a signal to be transmitted as a hybrid signal, which includes digital information to be added to an analog signal. The device may further include an ultrasonic receiver configured to receive ultrasonic signals from a mobile telecommunications device. The ultrasonic transducer may be configured to transmit a signal from the processing device as an ultrasonic signal and to receive ultrasonic signals from the mobile telecommunications device.

[0141] The device may further include a battery with 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 include 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 a signal to be transmitted as a digital signal. The device may further include an indicator showing when the device is communicating with a mobile telecommunications device. The processing device may further be 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 this disclosure also provide a wireless wearable wristlet device for detecting an electrocardiogram (ECG) signal from a subject wearing the device and wirelessly transmitting this information (e.g., by ultrasound) to a mobile telecommunications device. The wristlet device comprises a wristlet body configured to fit the wrist, two or more electrodes for detecting an ECG signal from a subject, a wireless (ultrasonic) transducer, and a processing device. The processing device may be coupled to the wireless (e.g., ultrasonic) transducer and configured to receive ECG signals from the two or more electrodes and encode the signal to be transmitted as a hybrid wireless (e.g., ultrasonic) signal, which includes digital information to be added to the analog representation of the ECG signal for transmission. The ultrasonic transducer may transmit signals at frequencies above about 17 kHz.

[0143] A hybrid ultrasonic signal may be configured to encode digital information using frequency-shifted modulation (FSK) and to append the FSK digital signal to an analog signal that is frequency-modulated but not encoded by FSK. A processing device may be configured to extract digital information from the ECG signal. The digital information may include calibration data for the analog signal. The processing device may be configured to encode the signal to be transmitted as an ultrasonic signal for transmission by an ultrasonic transducer at frequencies between approximately 17 kHz and approximately 30 kHz. An ultrasonic receiver may be configured to receive the ultrasonic signal from a mobile telecommunications device. An ultrasonic transducer may be configured to transmit a signal from the processing device as an ultrasonic signal and to receive the ultrasonic signal from a mobile telecommunications device.

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

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

[0146] Wearable computing devices may also take the form of a wristlet or armband. Aspects of the disclosure also provide an external housing or cover for a computing device worn on the wrist or arm. The external housing or cover may comprise two or more electrodes for detecting an ECG signal from a subject and a wireless transmitter for transmitting the ECG signal to a computing device worn on the wrist or arm.

[0147] Figure 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 that is coupled to or detachably attached to the computing device 1100. The computing device 1100 may comprise one or more of the following: a personal computer, a laptop computer, a tablet computer (such as Apple iPad®, Apple iPod®, Google Nexus tablet, Samsung Galaxy tablet, or Microsoft Surface), a personal digital assistant (PDA), a smartphone (such as Apple iPhone®, Google Nexus phone, or Samsung Galaxy smartphone), or a wearable computing device (such as Google Glass or Samsung Galaxy Gear Smart Watch). In many embodiments, the computing device comprises a tablet computer or a smartphone. The external sensor device 1200 may be configured to be detachably coupled to the computing device 1100 and may comprise a cover for enclosing the computing device, such as a tablet computer case or a smartphone case or cover. In this system, when a user US replaces or upgrades their computing device 1100, they may not need to replace the external sensor device 1200. In other words, the user can use the same external sensor device 1200 with 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, ROM, etc.), a network interface 1140 configured to connect to 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, for example, a local interface 1150, an operating system 1160 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 an online application distribution platform, and a user interface 1190. For example, the online application distribution platform could be the Apple App Store, Google Play, Windows Phone Store, BlackBerry App World, etc. The operating system 1160 may include instructions for operating the computing device 1100. The user interface 1190 may include 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 touchscreen 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 also include other components such as motion detection components, one or more cameras, additional displays, power supplies, fans, and various I / O ports.

[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 connect to the user US via a connection 1215, a physical contact, for example, to detect or identify one or more physiological parameters of the user US. Generally, one or more physiological parameters include cardiac parameters such as the user's heart rate, heart rate variability, blood pressure, blood pressure variability, arrhythmia, oscillatory cardiac graph (SCG), SCG parameters, electrocardiogram (ECG), or ECG parameters. Other physiological parameters are also conceivable. For example, the sensor 1210 may comprise an activity sensor, a blood glucose sensor, a blood oxygen saturation sensor, a thermometer, a respiratory sensor, a metabolic sensor, an odor detector, and the like. The processing device 1220 may receive the detected physiological parameters and process them into signals for the local interface 1230 to be transmitted to the local interface 1150 of the computing device 1100 via connection 1235. Connection 1235 may include wired connections such as USB, Firewire, or Lightning. Alternatively, or in combination, Connection 1235 may include wireless connections such as Wi-Fi, Bluetooth, Low Power Bluetooth, NFC (Near Field Communication), or Near Field Ultrasonic Communication, as described in U.S. Patents 8,301,232 and 8,509,882, among others.

[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 detected physiological parameters under instructions from the first application 1170. Furthermore, the processing device 1110 may, under instructions from the first application 1170, store the received physiological parameters in one or more of the computing device's memory 1120 or storage 1130. 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, under instructions from the first application 1170, cause the physiological parameters to be displayed on the user interface display 1195. For example, the physiological parameters may be displayed in real time as they are measured. The first application 1170 may also include algorithms executed by the processing device 1100 to analyze physiological data and present interpretations and analyses to the user US. For example, if an arrhythmia is detected, the processing device 1100 may, under instructions from the first application 1170, alert the user US, or a remote healthcare provider such as a physician, nurse, or hospital, via the network interface 1140. Furthermore, the processing device may be configured to automatically transmit physiological data via the network interface 1140 to a remote computing device, remote server, or a remote healthcare provider such as a physician, nurse, or hospital, under instructions from the first application 1170.

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

[0152] For example, the electrical activity of a user's heart can be detected and analyzed. A typical heartbeat may include several potential fluctuations that can be classified into waves and complex waves, including P waves, QRS complexes, T waves, and possibly U waves, as known in the art. The shape and duration of the P wave may be related to the size of the user's atria (e.g., showing atrial dilation) and may be the primary source of user-specific heartbeat characteristics.

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

[0154] The duration, amplitude, and morphology of the Q, R, and S waves can vary from person to person, and can differ significantly in users with heart disease or cardiac abnormalities. For example, a Q wave greater than one-third the height of the R wave, or a Q wave longer than 40 ms, may indicate a myocardial infarction and can provide unique characteristics of a user's heart. Similarly, other healthy ratios of Q and R waves may be used to distinguish between the heartbeats of different users.

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

[0156] The T wave can represent ventricular repolarization or recovery. The interval from the beginning of the QRS complex to the peak of the T wave can be called the absolute refractory period. The last half of the T wave can be called the relative refractory period or susceptible period. The amplitude of the T wave, the duration of the absolute refractory period, and the relative refractory period can also be used to define the characteristics of the user's heart rate.

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

[0158] Since a user's heart rate or heart rate may vary slightly based on the user's activity or mood, each approved user may initially provide the device with a basic or standard heart rate, heart rate, or electrical activity before first use. A first application 1170 may be performed by the processing device 1110 to record this standard measurement. For example, an external device or sensor 1200 may sample several heart rates or electrical activity at several different times to detect fluctuations in the electrical activity of the user's heart. 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 user's heart activity 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 the approved user's unique heart activity profile. Certain combinations of characteristics and associated ranges may be selected to minimize overlap with other approved users, or they may be based on characteristic values ​​and ranges that do not fall within a certain average value and average range (for example, not using characteristic values ​​and ranges that an average user of the device would have).

[0159] System 1000 may be used to authenticate user US based on the measured electrical activity of user US's heart, when compared to a generated profile. If the measured electrical activity matches the generated profile, processing device 1110 may authenticate user US under instructions from operating system 1160, first application 1170, or other applications. Processing device 1110 may also be instructed to perform any appropriate action in response to identifying and authenticating user US. In some embodiments, processing device 1110 may be instructed to provide access to restricted applications, such as applications licensed only to certain users or applications purchased only by certain users. In some embodiments, processing device 1110 may be instructed to provide access to specific data or application settings associated with the authorized user US. For example, 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 perform financial transactions using an electronic device (for example, transferring funds to different accounts or purchasing goods). In some embodiments, the computing device 1100 may load user US settings and profiles to provide the user with customized markings. For example, the computing device 1100 may display icons or options in a manner set by the user, or it may use a color scheme, font, or other customizable display attribute associated with the identified user.

[0160] In some embodiments, the system 1000 can determine the mood of a user US using detected heart rate or heart rate characteristics. 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 the distribution of detected characteristics within the acceptable characteristic range. Using the determined distribution, the processing device 1110 can establish the user's mood and provide the electronic device with behavior or data (e.g., media) associated with the estimated mood.

[0161] In some embodiments, the computing device 1100 can play media based on the detected mood or heart signal of the user US. For example, the computing device 1100 can identify media having a beat rate per minute or other characteristics associated with or related to the user US's heart signal or heart rate, and play the identified media. As another example, the provided media may have a beat rate per minute faster or slower than the user's current heart rate to instruct the user to move more vigorously (e.g., during exercise) or to cool down or calm down (e.g., at the end of exercise).

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

[0163] Alternatively, if the computing device determines that user US is authorized, the process may proceed to a fourth step, where the computing device 1100 determines restricted actions associated with 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 actions or applications associated with the authorized user US (e.g., applications purchased by user US using an application store, or system control actions associated with an administrator account). In the fifth step, the computing device 1100 may provide user US with access to the determined restricted actions. 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] While the second application 1180 is located in front of the display 1195 and is being actively operated by the user US, the first application 1170 may also run in the background of the operating system 1160, performing one or more of the following: receiving, storing, and analyzing physiological data. For example, the second application 1180 may include an email application, a web browser, a music player, or a game, which the user US operates 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 on the form of the computing device 1100 and the convenience of the user US.

[0166] Figures 2A to 2K show a biometric or physiological parameter measurement and observation system 2000 comprising a smartphone 2100 and a smartphone protective case 2200. Figure 2A shows a perspective view of the system 2200 with the smartphone 2100 and smartphone protective case 2200 separated. The protective case 2200 has a recess 2200C for housing the smartphone 2100. Figures 2B and 2C show a rear view of the system 2000. Figure 2D shows a perspective view of the system 2000 with the smartphone 2100 and smartphone protective case 2200 coupled to each other or detachably attached. 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, etc.

[0167] The smartphone 2100 may comprise a front 2110, a bezel 2120, a back 2130, and a display 2140 on the front 2110. The smartphone protective case 2200 may comprise multiple electrodes for detecting physiological parameters such as an electrocardiogram (ECG). The multiple electrodes may comprise a first electrode 2210 and a second electrode 2220. The smartphone 2100 and the protective case 2200 are coupled together, and at least some of the multiple electrodes are arranged to cover the bezel 2120 of the smartphone 2100. In this way, the thin, narrow contour of the smartphone 2100 can be maintained, for example, for user convenience. As shown in Figure 2B, the first electrode 2210 and the second electrode 2220 may be arranged facing each other on the upper and lower edges (i.e., the short side) of the protective case 2200, respectively. As shown in Figure 2C, the first electrode 2210 and the second electrode 2200 may be arranged facing each other on the left and right edges (i.e., the long sides) of the protective case 2200, respectively. Figures 2B and 2C show the back side 2200B of the protective case 2200. Each electrode is generally electrically insulated from each other to prevent short circuits or interference. Each electrode also generally protrudes slightly from the body of the protective case 2200. For example, each electrode may be polished, roughened, or otherwise finished to match the outer surface of the protective case 2200.

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

[0169] During use, the user may measure one or more physiological parameters, such as heart rate or ECG, as shown in Figures 2E and 2F, by holding the system 200 in their hand, touching the first electrode 2210 on their right arm RA, and the second electrode 2220 on their left arm LA. As shown in Figure 2E, the first application 1170 may be active on the system 2000 and display the measured parameters in real time. As shown in Figure 2F, the second application 1180, such as an email application, may also 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 and left arm LA, lead I ECG may be measured. The user US may also measure lead II ECG by touching the first electrode 2210 on the right arm RA and left leg LL. The user US may also measure lead III ECG by touching the first electrode 2210 on the right arm RA and left leg LL.

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

[0171] During use, the user can measure one or more physiological parameters, such as heart rate or ECG, as shown in Figure 2K, by holding the system 2000 in their hand and touching the first electrode 2210 on their right arm RA, the second electrode 2220 on their left arm, and the third electrode 2230 on their left leg LL. As shown in Figure 2K, a second application 1180, such as 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, left arm LA, and left leg LL, lead I ECG, lead II ECG, and lead III ECG can be measured. Lead I ECG, lead II ECG, and lead III ECG can also be measured simultaneously. A wireless ECG apparatus having three electrodes is further described in the jointly owned U.S. Provisional Patent Application No. 61 / 845,254, filed on 11 July 2013, entitled "Three-Electrode Wireless ECG Apparatus," the contents of which are incorporated herein by reference.

[0172] Figures 3A to 3F show a biometric or physiological parameter measurement and observation system 3300, comprising a tablet computer 3100 and a tablet computer protective case 3200. System 3000 may be similar in many ways 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. The tablet computer 3100 may include Apple iPad®, Google Nexus tablet computer, Samsung Galaxy tablet computer, Microsoft Surface tablet computer, etc.

[0173] Figure 3A shows a perspective view of the system 3000 such that the protective case 3200 has a recess 3200C for housing the tablet computer 3100. The tablet computer 3100 has a front 3110, bezel 3120, rear 3130, and display 3140. Figure 3B shows the tablet computer 3100 coupled to or detachably mounted in the protective case 3200.

[0174] Figure 3B also shows that the tablet computer protective case 3200 may be equipped with multiple sensor electrodes, including a first electrode 3210 and a second electrode 3220. As shown in Figures 3B and 3C, the first electrode 3210 and the second electrode 3220 may be arranged facing each other, covering the edge 3120 of the tablet computer 3100. Other alternative arrangements are also conceivable. For example, Figure 3D shows the first electrode 3210 and the second electrode 3220 arranged on the back surface 3130 of the protective case 3200. The multiple electrodes may further include a third electrode 3230 arranged on the back surface 3130 of the protective case 3200, as shown in Figure 3E.

[0175] System 3000 can be used in a similar manner to System 2000 described above to measure physiological signals. For example, multiple electrodes of System 3000 may come into contact with the user US to measure one or more of the Lead I ECG, Lead II ECG, or Lead III ECG. As shown in Figure 3F, the user US can operate 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. Figure 3F shows a first application 1170 for managing detected physiological parameters active on the tablet computer 3100, but it is also intended that a second application 1180 be active and operated by the user US while the first application 1170 and protective case 3200 detect and monitor physiological parameters.

[0176] Other computing device accessories are also envisioned for simultaneously measuring various physiological parameters of the user (US) while the computing device is being used normally.

[0177] Figures 4A to 4C show a biometric or physiological parameter measurement and observation system 4000 comprising a keyboard 4100 of a computing device 1100 and a keyboard accessory 4200 which may include a keyboard wrist rest. The keyboard 4100 may be detachably coupled to the keyboard accessory 4100 (compare Figures 4A and 4B). The keyboard accessory 4200 includes a physiological parameter sensor, such as multiple electrodes, including a first electrode 4210 and a second electrode 4220. As shown in Figure 4C, to detect lead I ECG while the user US is normally operating the computing device 1100 through the keyboard 4100, 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.

[0178] Figures 5A–5C show a biometric or physiological parameter measurement and observation system 5000 comprising a laptop or palmtop computer 5100 and a sensor accessory 5200. The computer 5100 can be detachably coupled to the sensor accessory 5100 (compare Figure 5A with Figure 5B). The sensor accessory 5200 comprises a physiological parameter sensor, such as multiple electrodes including a first electrode 5210 and a second electrode 5220. As shown in Figure 5C, to detect lead I ECG while the user US is operating the computer 5100 normally, 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.

[0179] Further sensor accessories for integration with devices used in daily life are also envisioned. For example, embodiments of the present disclosure may provide sensor accessories for handlebars, seats, chairs, eyeglasses, 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 take the form of watches, wristlets, wristbands, or accessories for such devices. ECG sensing watches and wristlets are described in co-owned U.S. Provisional Patent Application No. 61 / 872,555, filed August 30, 2013, entitled "Ultrasonic Transmission of Signals from an ECG Sensing Wristlet." Sensor accessories may detect and measure one or more physiological parameters and communicate the measurement results to a computing device associated with a device used in daily life or to another computing device.

[0180] Figure 6 shows a method 6000 for measuring and observing biometric or physiological parameters. 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 for 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, system 2000 (Figures 2A-2D), system 3000 (Figures 3A-3B), system 4000 (Figures 4A-4C), and system 5000 (Figures 5A-5C) described herein. In step 6200, a physiological signal or parameter measurement and observation application may be downloaded to the computing device. The application may include the first application 1170 described above, or it may be downloaded from an application distribution platform via the Internet as described herein. In step 6250, the application may be run on the computing device. In step 6300, an external device or shell coupled to the computing device may come into contact with the user to measure physiological parameters. 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 run on the computing device while the physiological signal or parameter measurement and observation application is performing its operations in the background.

[0181] The steps above illustrate a method 6000 for measuring and observing biometric or physiological parameters, but those skilled in the art will recognize many variations based on the teachings described herein. The steps may be completed in different orders. Steps may be added or omitted. Some steps may consist of partial steps. Many of the steps may be repeated to a useful degree.

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

[0183] Generally, apparatuses and methods for generating an electrocardiogram (ECG) from a patient are described herein, including handheld wireless telecommunications device cases having three electrodes on the outer surface of the case, and methods for using them. These apparatuses and methods may allow a user to hold up to six leads (e.g., lead I, lead II, lead III, aVR, aVL, and aVF) using a single handheld device, and these leads are more easily held by the patient against the patient's legs 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 for independent operation, 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 can be any suitable telecommunications device, including smartphones (e.g., iPhone®, Android®, etc.), tablets (e.g., iPad®, etc.), laptops, PDAs, etc. The apparatus may be configured as a case and / or attachment to a mobile telecommunications device. The apparatus may wirelessly transmit information to the mobile telecommunications device. In some variations, the system described herein transmits 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] Therefore, generally, the apparatus described herein may include a case or a housing configured otherwise. The housing generally includes an outer surface on which 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 rear, at least two outer sides perpendicular to the rear, and a front region through which the screen of the telecommunications device held inside the case can be seen.

[0186] For example, Figures 9A to 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 means of operating the phone.

[0187] Generally, the housing also includes at least (and in some variations strictly) three electrodes, one of each of which is intended to contact 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 so that the patient can touch the second electrode with their right hand and the third electrode with their left hand while holding the first electrode against their leg. The arrangement, shape, and / or size of the electrodes may be configured so that when measuring the ECG, the patient's hand does not come into contact with more than one electrode, and the patient's leg does not come into contact with more than one electrode on the housing. For example, the first electrode may be located on the side or side edge (back side edge) of the housing or both, while the second and third electrodes are located on the back, and all electrodes are spaced far enough apart from each other to avoid the leg or hand coming into contact with more than one electrode. Therefore, the left hand can contact one electrode, the right hand can contact another electrode, and the leg can contact the first (leg's) electrode, and all these electrodes are located on the same housing.

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

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

[0190] As previously mentioned, by placing the first electrode on the side, it may be possible to use the device to take measurements from the legs while viewing the surface (e.g., screen) of the telecommunications device inside the case.

[0191] In Figures 9A to 9D, the case contains only three electrodes 309, 311, and 313, with the first (leg) electrode positioned 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 positioned closer to the center of the outer rear 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 rest of the outer surface of the case.

[0192] Figures 10A–10D show another variation of the case with 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, and instead, the third electrode protrudes from the outer surface, as shown in Figure 10D. The case shown is otherwise similar to the variation shown in Figures 9A–9D, except that these figures are shown without a mobile telecommunications device (e.g., a smartphone) inside the case.

[0193] In some variations, as shown in Figures 11A to 11C, the leg electrode (electrode 1) 509 extends from the side to the back where the other electrodes 511 and 513 are located.

[0194] Alternatively, in some variations, the leg electrodes are positioned near the edge of the case (for example, near the side edge), as shown in Figure 12C. Generally, the leg electrodes may be adjacent to one of the sides. The electrodes may be right next to the side or in contact with the edge. Figures 12A–12C show a case configured such that the first electrode 613 is adjacent to the side of the case, and the second electrode 609 and 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] Figures 7A–7C show another variation of the case having a first electrode 709 extending from the back through the lateral 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 hold the case at a certain angle by contacting the legs.

[0196] In some variations, the housing may be configured to hold an electrode unit that fits into an opening on the outer rear of the case, and the electrode unit may include second and third (and possibly first) electrodes and circuitry for controlling / receiving ECG recordings. For example, Figures 14A–14C show a device configured as a case holding an electrode unit 805, which includes second electrodes 811 and third electrodes 813 to be touched by the patient's right and left hands, and a separate first electrode 809 located on the side of the case. The electrode unit may protrude from the case and may include an outer (non-electrode) surface that extends longer 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] Figures 15A to 15C show another variation of the three-electrode housing, where all three electrodes (the first electrode 909, the second electrode 911, and the third electrode 913) are arranged on the back of the case, as shown in Figure 15.

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

[0199] For example, Figure 17 shows how to operate a device 400 having electrodes for both hands (right hand, left hand) and electrodes for the legs. In this example, subject SU is seated in a chair CH and holds the device 400, which is configured as a smartphone case for holding a smartphone, in 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 so that the leg electrodes are pressed against the legs. The case and smartphone may then be used to record leads 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 using three electrodes (for example, by any of the devices described herein). For example, in one embodiment, as described herein, a device having three electrodes may be used to simultaneously determine lead I (e.g., the voltage between the left arm and the right arm) and lead II (e.g., the voltage between the left leg and the right arm), and lead I simultaneously determine lead V2. In other embodiments, any other combination of leads is possible. Processing logic may then synchronize the timing of two sets of records so that two sets of measurements can be compared over the same simulated period.

[0201] The processing logic may further transform two sets of reads to generate a complete 12-lead ECG. In one embodiment, the processing logic may use a machine learning model (e.g., a neural network, deep learning technique, etc.) to perform such a transformation. The machine learning model may be trained using 12-lead ECG data corresponding to a population of individuals. The data may be preprocessed to filter the data in a manner suitable 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 one or more models are fine-tuned for a particular type of individual. In a further embodiment, the machine learning model may be further trained on user-specific ECG data to fine-tune the model even further.

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

[0203] In general, devices and systems for ultrasonically transmitting information (e.g., biological parameter information) from a wearable (e.g., wristlet) sensing device to a telecommunications device capable of subsequently processing and / or transmitting the biological parameter information, via an ultrasonic transmitting device, are also described herein. Specifically, the biological parameters may include ECG signals. The wearable device typically includes 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 wristlets worn by a subject.

[0204] As will be explained in detail below, in some variations, ultrasonic signals (e.g., encoding an ECG) can be securely transmitted using an encryption key. Systems, methods, and devices for easily pairing an ultrasonic transmitting device with a telecommunications device using an encryption key are also described herein. For example, in some variations, a telecommunications device can read (e.g., take an image of) the encryption key displayed on the ultrasonic transmitting device. This technique can be easily performed by taking an image of a mark containing the encryption key (e.g., a barcode, QR code®, etc.) with the telecommunications device and determining the encryption key based on the image. Executable logic (e.g., decryption logic) running on the telecommunications 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 sensors for detecting biological parameters (e.g., vital signs), a processing device for structuring a representation of the biological parameters 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 a controller (e.g., a microcontroller), be controlled by it, or communicate with it. The telecommunications-enabled device (telecommunications device) may include a receiver (audio receiver) capable of receiving audio signals in the ultrasound range, and a processing device for converting the ultrasound signal back into an electronic signal for further processing or transmission.

[0206] While the human hearing range is often said to be from 20 Hz to 20 kHz, under ideal laboratory conditions, a child's maximum hearing range actually extends to around 12 Hz, rarely remaining 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. Therefore, sounds above approximately 16 kHz must be of considerable intensity to be heard. From almost immediately after birth, the threshold sound levels for these higher frequencies begin to rise. As shown in Figure 19, the average 20-year-old loses about 10 dB in the 8 kHz range, and by age 90, the average person loses more than 100 dB at this frequency.

[0207] An exemplary product that uses very high-frequency sound is the mosquito alarm, a controversial device used to deter young people from loitering by deliberately emitting an unpleasant 17.4 kHz alarm. Due to adults losing hearing at this frequency, this sound is typically only audible to people under 25 years of age. Similarly, students exploit adult hearing loss by using 15-17 kHz “mosquito” cell phone ringtones at school. Students can hear the “mosquito” ringtones, but adult teachers cannot. The term “ultrasound” usually means beyond the range perceptible to humans. However, as shown, the upper limit of the audible frequency range generally varies by individual and age. Due to this difference in the upper limit, the term “ultrasound” as defined herein and in the appended claims may refer to sound frequencies above 16 kHz (e.g., higher than about 17 kHz, higher than 18 kHz, etc.).

[0208] However, interestingly, ambient noise or sounds above approximately 10 kHz are very rare. Referring to Figure 20, most everyday sounds occur at frequencies below approximately 4 kHz. Therefore, using signals in the ultrasonic range not only provides quietness to those nearby, but also a very desirable signal-to-noise ratio (SNR).

[0209] Acoustic engineers can confidently assume that frequencies above approximately 20 kHz do not affect perceived sound and can filter out all sounds above this range. Sounds below 20 kHz but within the ultrasonic range are rarely problematic, and standard sampling procedures have been established accordingly. It is generally understood that sampling an analog signal, whether it is a radio signal or an audible speech signal, requires a sampling frequency fs such that fs / 2 > f, where f is the frequency of the sine wave. For this reason, acoustic systems are designed to sample sound at 44.1 kHz, which is now a standard sample rate, set somewhat higher than the calculated Nyquist-Shannon sampling rate of 40 kHz for the upper limit of sound at 20 kHz. Actual demodulation of FM narrowband signals in the ultrasonic range using existing demodulation procedures, such as computers, telephones, mobile phones, and stereo sound systems, reproduces the original signal very poorly. This is unfortunate, as it is 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 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 utilize ultrasonic signals, which have a significantly improved signal-to-noise ratio compared to conventional telephone transmission methods. Methods and algorithms for receiving and demodulating ultrasonic signals with remarkable accuracy using existing computer and smartphone technologies are also provided.

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

[0212] Figure 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 biological parameters from a patient (e.g., body temperature, heart rate, blood glucose, etc.) and a microcontroller 0405. The microcontroller may include, or be coupled with, a processing device for encoding a digital representation of the biological parameters, and this encoded signal may be converted into an ultrasonic signal, as will be described in more detail below. For example, the encoded signal may be transmitted ultrasonically by an ultrasonic transducer 0407. This ultrasonic signal 0420 may then be received by a telecommunications device 0425, which includes an audio pickup (receiver) 0429. The telecommunications device 0425 may receive the ultrasonic signal and convert it so that it can be processed, for example, by preparing the telecommunications device to convert it back into an electronic signal and interpret what type of signal it is (e.g., heart rate, body temperature, etc.), and perform client control logic 0427.

[0213] Therefore, the medical sensing device 0401 in this example includes a sensor (or sensor assembly) configured to detect one or more physiological signals, such as body temperature, heart rate, and pressure (e.g., blood pressure). The sensor can generate electrical signals representing the detected physiological signals, and these signals can be converted into one or more digital signals to be input to a microcontroller or other related component. These digital signals may typically be displayed on the device (not shown), and may also be electrically encoded as part of the digital signals that can then be ultrasonically encoded (e.g., by techniques such as frequency shift modulation) into ultrasonic sound and emitted from the device. The encoding of the signals can be performed by any suitable circuit, including a microcontroller such as an MSP430 (e.g., Texas Instruments' AFE4110).

[0214] The center frequency can be selected from any suitable ultrasonic frequency, including (but not limited to) 20 kHz. In some variations, the medical sensing device described herein is configured to transmit only, so that data is sent to (but not received from) a telecommunications device. In some variations, the medical sensing device is configured to both transmit and receive ultrasonic (sound) frequency information (see, for example, Figures 21C and 27). Furthermore, in some variations, multiple channels (frequency channels) may be used.

[0215] Figure 21C shows a schematic diagram of a medical sensing device (for example, a wristlet configured as an "ECG watch" to detect an ECG signal and transmit it to a telecommunications device). In this example, the device (e.g., the wristlet) includes a sensor 0403. In some variations, the sensor may include two or more electrodes for detecting an ECG signal. An ultrasonic transducer may be configured as both an ultrasonic transmitter and an ultrasonic receiver. In some variations, the same transducer element (e.g., a piezoelectric element) may be used for both. A telecommunications device 0425 may be configured to both receive (via an audio pickup 0429) and transmit (via an ultrasonic receiver 0433) ultrasonic waves, such as the ultrasonic waves transmitted by the medical sensing device 0401.

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

[0217] Figure 22 shows one variation of a digital signal encoded using shift modulation. In this variation, the ultrasonic signal is modulated at two different frequencies, one representing high ("1") and the other representing low ("0"). For example, the frequencies for 0 and 1 can be selected around approximately 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 generally, the sensor can include any suitable sensor capable of operating to detect physiological signals 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, heart rate, pulse oximetry, photoplethysmogram (PPG), and body temperature. A respiration detector may be used. Heart rate and heart rate may also be detected. For example, the oxygenation of a person's hemoglobin can be observed non-invasively and indirectly using a pulse oximetry sensor rather than directly measuring it 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. Changes in the absorption rate of each of the two wavelengths are measured, and the difference is used to estimate changes in the oxygen saturation of the person's blood and the volume of blood in the skin. A photoplethysmogram (PPG) can then be obtained using a pulse oximeter sensor or an optical sensor using a single light source. PPG can be used to measure blood flow and heart rate. A digital representation of this data can then be transmitted, as described herein. In some variations (described below with reference to Figures 26A and 26B), analog information can also be encoded and / or appended to digital information to form a hybrid of analog and digital information transmitted by the ultrasonic transmitting device.

[0219] In some variations, the transducer assembly converts electrically encoded biological parameters (e.g., digital, analog, etc.) into a transmittable ultrasonic signal. In the embodiment shown in Figure 21A, the transducer assembly 0405' includes an ultrasonic transducer 0407 for outputting the 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 telecommunications device 0425, ultrasonic signals can be received by a microphone 0429 of a device such as a smartphone, personal digital assistant (PDA), tablet personal computer, pocket personal computer, notebook computer, desktop computer, or server computer.

[0221] To conserve power, the signal volume may remain low, but since it is inaudible, higher volumes are also possible. For example, at ultrasonic frequencies, the signal volume can be increased further without worrying about the presence of a "listener" because it is inaudible. Furthermore, the signal can be encoded to prevent other devices (not paired with the ultrasonic transmitting device) from receiving and understanding it.

[0222] As mentioned above, a telecommunications device may include a processing device consisting of client logic (e.g., software) for receiving and processing ultrasonic signals. For example, software on a smartphone can decode ultrasonic signals. Data processing may provide additional user-relevant information, including the type of information (e.g., the nature of biological parameters). For example, a signal may be encoded to include (after the start identifier) ​​eight pulses indicating ECG data, ten pulses indicating a thermometer reading (e.g., four digits with the last digit after the decimal point), twelve pulses indicating a blood pressure reading (e.g., three digits for systolic blood pressure, three digits for diastolic blood pressure, and three digits for heart rate), fourteen pulses indicating pulse oximeter data (e.g., three digits for oxygen saturation and three digits for heart rate), sixteen pulses indicating blood glucose meter data (e.g., three digits for blood glucose level), etc. There may be a "separator" between the digits and the EOM (End of Message) indicator. In practice, the signal may be transmitted several times so that comparisons between the received data can be performed for verification.

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

[0224] In some variations, the signal may also include analog data having a spread (e.g., a signal over time, a signal over distance) for transmission together with digital information that formats or is extracted from the analog data (e.g., scaling the analog data). For example, a signal for ultrasonic transmission from an ultrasonic transmission device may include one or more digital portions and one or more analog portions. The digital portion may include information extracted from the analog signal such as scaling (e.g., maximum and / or minimum values), time duration, average, etc. The analog signal, digital signal, and analog - and - digital (hybrid) signals may be encoded, including being encrypted, and / or may include error - correcting codes.

[0225] As mentioned, the signal may have a timestamp and / or a 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 remote communication device. For example, the measurements may be taken at times t1, t2, etc., stored in a device (e.g., a thermometer, a blood - glucose meter, etc.), and later (at tn) transmitted via ultrasound to a remote communication device (e.g., a smartphone, a tablet, etc.). The data may be processed by the remote communication device and / or uploaded to an external server (e.g., the cloud).

[0226] The baud rate of the transmitted ultrasonic data may be selected to enable fast transmission. For example, if a baud rate of about 300 baud is used, transmission may take less than 1 second even for batch - processed signals. In some variations, the baud rate is around 400.

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

[0228] Ultrasonic signaling as used herein generally refers to transmitting information such as the magnitude of biological parameters along with the origin of the results of biological parameter measurements using ultrasonic signals. As mentioned, these ultrasonic signals may be encoded to enable transmission and processing. The encoded signals may then be converted to an ultrasonic range by any suitable method. For example, one or more frequencies corresponding to various signal values, such as DTMF or frequency-shifted DTMF to ultrasonic frequencies, may be used. Another example of converting the signal is using amplitude shift modulation. Another example is using frequency shift modulation. Another example is using phase shift modulation. In some embodiments, multi-frequency signaling, such as spread spectrum communication or multi-frequency carrier signaling, may be used. An example of multi-frequency carrier signaling involves specifying a predetermined set of frequencies spaced apart by intervals such as between 40 Hz and 100 Hz, such as approximately 65 Hz (e.g., between 20 kHz and 22 kHz, or between 20 kHz and 24 kHz, or generally between 19 kHz and 20 kHz, with an upper limit equal to or slightly lower than the Nyquist frequency of the intended receiver's sampling rate), and for each such frequency, encoding a bit "1" to indicate the presence of a carrier signal, such as a sine wave, at that frequency, and a bit "0" to indicate the absence of such a signal. A receiver of such a multi-frequency signal can then perform a Fast Fourier Transform or related techniques known in the art to determine whether a carrier is available at each relevant frequency, thereby inferring a set of bits to encode a certain number. In some embodiments of multi-frequency carrier signaling, for example, when the clarity of the signal is insufficient, multiple samples can be taken over time and averaged, and the averaged signal can be processed as described above. In some embodiments of multi-frequency carrier signaling, a Viterbi decoder can be used to decode the bit pattern, for example, if the frequencies are close enough to cause interference. Generally, techniques known to those skilled in the field of communications, particularly with respect to modulation and demodulation (e.g., modems), can be used.Examples of such techniques include the various modem standards designated as Vx (where x is an integer) published by the International Telecommunication Union T Section, which are incorporated herein by reference in their entirety for all purposes.

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

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

[0231] In some variations, transmission from a medical sensing device to a telecommunications device is unidirectional, typically resulting in design simplicity, lower cost, and lower power consumption. These advantages are particularly useful when comparing a system in which the medical sensing device includes an additional receiver (including a microphone or antenna for receiving sound waves). However, in some configurations, the medical sensing device can be adapted to receive a simple indicator signal from a telecommunications device without the need for an additional receiver such as an antenna or microphone. For example, in some variations, an ultrasonic transducer (e.g., a piezoelectric speaker) can be used as a 20kHz sensor to implement a reply acknowledgment (ACK). For example, a telecommunications device (e.g., a telephone) could produce a short 20kHz burst after receiving, decoding, and verifying a CRC to signal the sensor that it has received the CRC correctly and that retransmission is not necessary. In other variations, the signal from the telecommunications device could indicate that it is ready to receive a transmission from the biometric device. Time-separated signal / acknowledgment pairs or more may also be used.

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

[0233] In some embodiments, data transmitted by ultrasonic 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, sparse graph codes such as Goppa codes, Hadamard codes, Hagelbarger codes, Hamming codes, Latin Square-based codes, Lexicographic codes, 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, in combination, or in combination with error detection codes such as parity and cyclic redundancy checks. Error correction codes may be decoded and applied according to their respective techniques to correct transmission and / or reception errors at the receiver or at a server receiving communications from the receiver.

[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 the Texas Instruments MSP430 digital thermometer is adapted to include firmware that allows it to ultrasonically transmit body temperature measurements (digital data) to a mobile telecommunications device (e.g., iPhone®). While this example is specific to the APE 4110 microprocessor (one variation of Texas Instruments' MSP 430 microprocessor), other microprocessors may be used and adapted as well as the firmware, software, and / or hardware to function.

[0235] Generally, a device may take data (e.g., body temperature readings from a thermometer) and encode it for ultrasonic transmission. The encoded signal may include error checking (e.g., CRC coding, Hamming coding, etc.) and may be encrypted. For example, the data may be encrypted using, for example, the Advanced Encryption Standard (AES). U.S. Patents 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 encoded and / or encrypted into one or more data packets for transmission. A microprocessor may encode the data and then transmit the packets by driving a piezoelectric speaker. As mentioned above, frequency-shifted modulation (FSK) may be used, in which two separate ultrasonic frequencies (e.g., 18817 Hz and 19672 Hz) are used to transmit Boolean 0 and 1, respectively. Control logic (data ultrasonic modem logic) may both compose, encode, and encrypt the data and control the driving of the speaker (e.g., piezoelectric transducer) to transmit the prepared packets of encoded / encrypted data. 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 determine the start time of the transmission.

[0237] For example, in one modification, the thermometer normally measures body temperature, and when the temperature settles at a certain value, the thermometer emits an audible beep to inform the user that the value can be read. This thermometer (in its initial unmodified configuration) includes a microcontroller (e.g., AFE4110) and a piezoelectric speaker, the microcontroller driving the speaker to emit the beep. By modifying / configuring the microcontroller as 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 signals, such as a smartphone, which executes digital ultrasonic modem receiver logic.

[0238] In this example, the microprocessor may include the following (exemplary) symbols to enable the functions described above. Figures 23 and 24A–24E show flowcharts 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] The steps above illustrate the method of transmitting data as shown in Figures 23 and 24A–24E, but those skilled in the art will recognize many variations based on the teachings described herein. The steps may be completed in a different order. Steps may be added or omitted. Some steps may consist of substeps. Many of the steps may be repeated to a useful degree.

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

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

[0243] For example, Figure 25 shows one variation of a flowchart illustrating a method for receiving, demodulating, and detecting a digital ultrasonic signal. In this example, the application (receive control logic) receives binary FSK encoded data via a microphone input. For example, the input could be from a smartphone's microphone. As discussed above, binary FSK encoding uses a "mark" frequency Fr to represent the binary value 1 and a "space" frequency F to represent the binary value 0. s These two frequencies are used. In this implementation, a carrier wave is not used.

[0244] The application consists of two largely independent components: a demodulator that extracts mark frequency and space frequency components from 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 has a frequency of S>2*max(F m9 Audio samples are received from the microphone hardware at a sample rate S such that F8). The audio samples are processed by two frequency detectors that calculate the intensity of the mark frequency component and the space frequency component of the received signal (respectively). The Goertzel algorithm is used for frequency detection in this implementation. To achieve sufficient frequency resolution between the mark frequency and the space frequency, the Goertzel algorithm is applied to a sliding window of G samples, where G = S / abs(F8). m -F)

[0245] The outputs of the Goertzel algorithm for the mark frequency and space frequency 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 approximately zero when no transmission is taking place, rises to a positive value when the "mark" frequency is active, and falls 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: a computationally simple evaluation to remove most false positives due to random noise, followed by a more computationally expensive evaluation to remove the remainder.

[0247] When 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 rest of the packet. And now, in this example, the decoder reads each encoded byte. The decoder uses the stored equalization parameters to determine the minimum amplitude threshold for the start bit of each byte. When a valid start bit is received for a given byte, the subsequent bits are evaluated based on the sign of the demodulated waveform without a minimum threshold for decoding.

[0248] If a valid start bit is not received, the decoder aborts reading the packet and waits for silence or until a fixed length of time has elapsed before resuming listening for a new packet. Each logical byte in the packet is actually transmitted as two encoded bytes: a first encoded byte containing the Hamming-encoded lower nibble of the logical byte and a second encoded byte containing the Hamming-encoded upper 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. Subsequently, each logical data byte is read.

[0250] After the data bytes are read, two logical checksum bytes are read, and the received checksum value is compared to the value calculated for the received data bytes. If these two checksum values ​​match, the packet is considered valid and 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 a packet, the decoder resumes listening for new packets.

[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 communication capabilities of a telecommunication device. For example, the data may be displayed on a smartphone, and / or uploaded to a medical database for storage and / or for later review.

[0252] The steps above illustrate the method of transmitting data as shown in Figure 25, but those skilled in the art will recognize many variations based on the teachings described herein. The steps may be completed in a different order. Steps may be added or omitted. Some steps may consist of substeps. Many of the steps may be repeated to a useful degree.

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

[0254] The above example describes a system configured to transmit digital information, but the techniques, devices, and systems described herein may also be configured to transmit analog signals, and / or analog-digital hybrid signals. Generally, the techniques described involve the use of a timer (e.g., in a microcontroller) transmitted 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. Furthermore, in some variations of the system, the output is a more conventional speaker (albeit in the ultrasonic range) rather than a piezoelectric element. Additional digital-to-analog (D / A) conversion may occur during transmission.

[0255] For example, Figures 26A and 26B show one variation of a hybrid digital / analog format that may be used with an ultrasonic transmitter. Generally, the signal may include digital components that are modulated or configured for ultrasonic modem transmission. For example, the digital signal may be encoded as an FSK signal, and the data (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 ultrasonic transmitting device is configured as a pulse oximetry measurement / observation device. In this example, the information obtained from pulse oximetry may be scrutinized to extract information such as minimum values, maximum values, and duration of the analog signal, and may be digitally encoded and stored in a buffer (using one or more encryption and / or error correction codes) and / or transmitted by ultrasound. The analog signal may be combined with a digital signal (or extracted signal) that is transmitted to a transmitting element and can be received by a telecommunications 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 peak, minimum value, duration, time interval, etc. of the analog signal from the analog signal (e.g., a time-varying pulse oximetry signal). Thus, the hybrid signal may include extracted digital information or tagged digital information, as well as waveforms (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, such as duration and heart rate, as well as information about the ECG waveform (if previously analyzed), such as interval data.

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

[0259] There are many potential advantages to transmitting hybrid analog / digital signals that can be read and understood by telecommunication devices. For example, if the hybrid signal includes a series of values ​​(e.g., minimum / maximum values) and waveforms (e.g., ECG, heart rate, etc.), this type of hybrid digital / analog system can enable more efficient communication than FSK value data alone.

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

[0261] In one example, as previously mentioned above, an ultrasonic transmitting device is a thermometer containing the ultrasonic modem element described above. An ultrasonic thermometer device is configured to cover a temperature range of approximately 95°F to 106.7°F for its actual range of use. Thus, body temperature can be transmitted with a resolution of typically 0.1 (for example, there are 120 values, so 8 bits may be all that is needed). In a device configured to encode byte-metric data with a hybrid signal, the digital component of the signal may be appended first, or the signal may contain information about the analog signal after the digital-only signal, although the analog signal may be appended to or embedded in the rest of the signal, and the digital information may be extracted from the digital signal to be included with it. An example of a hybrid signal may include a thermometer device like the one mentioned above, which displays body temperature as a function of time, measured value, and / or recorded value, transmitting maximum / minimum 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 (for example, configuring an ultrasonic transmitting device as a glucose meter), which may transmit a blood glucose signal (a digital signal including maximum, minimum values, etc.) and one or more graphs showing waveforms of blood glucose levels over time.

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

[0263] As mentioned, Figure 26A shows one variation of the hybrid digital / analog format that may be used as described herein. In this example, the signal includes an initial digital component 0901, which is encoded for ultrasonic transmission using a technique such as FSK (or any other technique known in the art). The digital information may be decomposed as appropriate into bits, bytes, words, etc. The size and arrangement of the digital information may be predetermined. Error correction codes (e.g., Hamming codes) may be included. In Figure 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), and additional data 0909 about the analog signal (e.g., type, timing, datestamp / timestamp). Any other digital information may be included. The signal then may include an analog component 0903. In Figure 26A, the analog signal is somewhat free and may continue for a fixed or unfixed time length. In some variations, the entire signal may be repeated for reception by a telecommunications device. Figure 26B shows a similar variation of the hybrid signal format, where a digital component 0901 is appended to an analog component 0903, and an additional digital component 0911 ("end" signal) may be appended at the end. In some variations, multiple analog components may be combined with multiple other analog components. The entire signal may be encrypted before transmission, as described below.

[0264] In some variations, a hybrid digital / analog format may be used to encode stored data held by a device (ultrasonic transmitting device) for a certain period 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 (a graph over time) described / calibrated by a digital data component and transmitted to a telecommunications device.

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

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

[0267] In this way, an ultrasonic transmitting device can be uniquely paired with a secret encryption key that can only be read by a telecommunications device that possesses and applies the encryption key. The encryption key is easily displayed and easily determined by the telecommunications device. Thus, in some variations, each ultrasonic transmitting device may have a unique ID printed on the device, providing a code that must match the telecommunications device. By scanning the printed encryption key, the telecommunications device becomes able to decrypt the data.

[0268] Figure 27 schematically illustrates one variation of a system including an ultrasonic transmitting device ("source device" 01031) with a visible cryptographic key 01051 on the body of the device, which can be read and applied by the telecommunications device 01025 to decrypt the transmitted ultrasonic transmission. Figure 27 also illustrates one variation of the device and system in which the ultrasonic transmitting device ("source device" 01031) communicates bidirectionally (or to a limited extent bidirectionally) with the telecommunications device.

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

[0270] For simple acknowledgments, a piezoelectric element / speaker used by a device (an ultrasonic transmitting device) to transmit data can be used as a frequency-tuned sensor. Generally, a piezoelectric element for transmitting sound 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 piezoelectric element's resonant frequency where the piezoelectric element is most sensitive. The duration and coding of such a "frequency burst" can be configured to be easily recognized by the low-power electronics of a health management / fitness sensing device. For example, an acknowledgment pulse can be filtered and detected as simply the presence of a certain ultrasonic frequency for a predetermined duration.

[0271] In some variations, symmetrical bidirectional communication can be achieved using well-established telephone modem techniques simply by changing the carrier frequency to the ultrasonic range. Examples include telephone modem modulation techniques based on FSK (Frequency Shift Modulation), QAM (Quaternary Amplitude Modulation), and PSK (Frequency Shift Modulation). These telephone modem techniques assume that only two devices are attempting to communicate. Radio frequency protocols can be used to enhance the modem protocol to allow multiple devices to communicate simultaneously without errors.

[0272] Implementations of such bidirectional communication techniques may include additional processing power in the device sufficient to perform the signal processing necessary to demodulate and decode the received audio. This processing power may require additional battery power and physical space in the device. A partial list of existing modem communication standards that could 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] With respect to Figure 27, the source device may include additional transducers / microphones for receiving ultrasonic signals from the telecommunications device, and for controlling them and supporting processing (e.g., microprocessor / microcontroller logic) for interpreting communications (which may be encoded and / or encrypted) and executing any instruction functions. Similarly, the telecommunications device may include a speaker (piezoelectric element) configured to emit ultrasonic signals.

[0274] From the above description, it is clear that the invention concepts disclosed and claimed herein are well adapted to perform and benefit from the purposes referred to herein and inherent in the invention concepts disclosed and claimed herein. The embodiments presented are described for the purposes of this disclosure, but it will be understood that numerous modifications can be made, which will be readily apparent to those skilled in the art and will be achieved within the spirit of the invention concepts disclosed and claimed herein.

[0275] Example 2: Heart rate monitor using audio tones for heart rate transmission Any of the devices, systems, and methods described herein may be configured as wireless (ultrasonic) heart rate monitors adapted for use with mobile telecommunications (computing) devices such as smartphones. See also Example 3 below, which describes a wearable ECG monitor that may also provide heart rate information (for example, by extracting the heart rate from the detected ECG signal). A wearable component for detecting heart rate (e.g., a wearable monitor) may be configured as a wristlet, anklet, armband, chest strap, belt (collectively, a “strap”), and may transmit information wirelessly via any of the ultrasonic methods described above, including the use of receiver-side control logic (e.g., software, hardware, etc.) for receiving, storing, and / or analyzing the detected (biometric) information.

[0276] Most heart rate monitors consist of a chest strap incorporating an ECG amplifier, an R-wave detector, and a circuit that outputs a 5kHz electromagnetic pulse, typically 50ms wide, when an R-wave is detected. This electromagnetic pulse is detected by a watch or other receiver, which then measures the interval between pulses to calculate and display the heart rate. This configuration requires a special receiver, which may not be present in a mobile phone or computer, so without additional equipment, they cannot receive heart rate information. Because the configuration usually uses short-range electromagnetic transmission, the range is also limited to about 1 meter.

[0277] In one variation of the devices and systems described herein, a heart rate monitor may include a strap (e.g., a chest strap, wristlet, etc.) incorporating a circuit for an ECG amplifier, an R-wave detector, and a circuit for outputting an audio tone (signal) typically 5 ms wide (e.g., within the ultrasonic frequency range of approximately 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 built-in microphone of a smartphone device, which can then measure the interval between tones and calculate and display the heart rate. The mobile computing device (e.g., a phone) may include software, firmware, or hardware (but typically software including an application or “app” that can be downloaded from a remote server) for controlling the mobile device to receive and analyze the audio (e.g., ultrasonic) tone, calculate the heart rate, store the heart rate, upload it, and / or display it.

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

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

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

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

[0282] The first embodiment is one in which each heart monitor uses different audio frequencies that are sufficiently separated to allow Doppler shift when the heart rate monitor is moving rapidly relative to the receiver, and to allow frequency distinction with a high signal-to-noise ratio.

[0283] Therefore, each cardiac monitor does not need to be set to a specific tone frequency; the frequency may be determined by a pseudo-random sequence when the R-wave heart signal is first detected after the cardiac monitor is initially attached. The audio tone is then fixed until the cardiac monitor is removed. Thus, each monitor does not need to be coded independently.

[0284] If the heart rate monitor emits audio tones in the 18kHz to 22kHz range, a 500Hz interval may be used. This makes nine audio operating frequencies available for each monitor.

[0285] The pseudo-random allocation of the frequencies to be used can be achieved by providing a counter that increments over time from the moment 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 can be changed by removing and reattaching the monitor to the body.

[0286] In the example above, since the two cardiac monitors are using the same frequency and are close together, in rare situations where some degree of interference is possible, the frequency of one monitor can be changed by removing and reattaching it. The receiving device can also detect such interference and advise the user to remove and reattach the monitor if necessary.

[0287] The receiving device can determine the audio tone frequencies of a specific ultrasound transmitting device (in this example, a cardiac monitor) by performing spectral analysis of the received audio. Once the audio tone frequencies are 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 is calculated by measuring the intervals between the audio tones. Since the duration 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 of the same frequency but different durations. The duration of each tone can be measured by the receiving device. Only tones of a specific duration are used to calculate the heart rate for a particular heart rate monitor. If two heart rate monitors are close together, and the receiving device picks up audio tones from both monitors simultaneously, the receiving device can distinguish them based on the tone durations. Since the tone duration is short compared to the interval between tones (the interval between heartbeats), it is unlikely that audio tones will arrive simultaneously, but if they do, 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., including bursts of multiple pulses at high frequencies), 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). Therefore, a system for measuring heart rate may include a monitor (e.g., a heart rate sensor) containing a transducer for creating an audio signal (e.g., one or more pulses) that is timed to the patient's heart rate. Thus, the monitor acts 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, the smartphone performing the control logic.

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

[0292] Example 3: Listret for detecting motion and / or ECG signals Figures 28A and 28B illustrate another variation of a wearable device that can detect health parameters and transmit them ultrasonically to an observation station (e.g., a smartphone) controlled by control logic to receive and / or trigger the information from the wearable device via ultrasound.

[0293] Figure 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 Figure 28A, the outer surface of the device is schematically shown. A first conductive (e.g., metallic) window 01151 is visible on the outer surface of the wristlet, and a second conductive (e.g., metallic) window 01153 is visible on the inner surface of the wristlet. These electrodes may allow the user to press the electrodes and wristlet downwards to make electrical contact with the skin. The inner electrodes may be in contact continuously or periodically during normal use. The conductive windows may also be thermally conductive and may be connected to a body temperature sensing module.

[0294] A wristlet may be flexible so that it can be wrapped around the wearer's wrist and secured. A wristlet may be flexible so that it remains in position once 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 sweatproof and waterproof while worn.

[0295] As shown above for the conductive window region, the outer portion of the ristret can be adapted to transmit energy from the module within the ristret through the outer protective housing. For example, the conductive window region shown above. The region of the ristret covering the ultrasonic transducer 01184 can also be adapted to allow the passage of ultrasonic signals. In some variations, the ends of the ristret are adapted to allow the passage of ultrasonic signals by including a relatively rigid end cap that can readily convert ultrasonic energy. In some variations, the outer (e.g., polymer) covering consists of a material known in the art to be relatively permeable to ultrasound. In some variations, the end region (or the opposite end region) can also be adapted to allow the device's battery to be recharged.

[0296] Figure 28B shows an exemplary internal schematic of a wristlet, illustrating its internal module (structure). As mentioned, it may include any suitable sensors, 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, which may be electrically connected to conductive windows 01151, 01153 on the outer surface. In some variations, the outer surface is the electrode. In other variations, the conductive surface extends around the length of the inner surface of the wristlet (for example, toward the lower electrode) so that it is likely to come into contact with at least a portion of the bare skin of the wrist whenever the device is worn. Similarly, the conductive surface outside the upper electrode may extend entirely around the outer (outward-facing) surface of the wristlet. Additional sensors may or may not be included. For example, in one variation, the wristlet includes only a motion sensor and no electrodes.

[0297] In some variations, the wristret also includes a tactile feedback element, a vibration motor 01194. This vibration motor may generate an oscillation frequency to provide feedback from the device to the user. In some variations, the wristret may also include a button or contact area that allows the user to manually trigger one or more functions of the wristret and / or observation station, such as ultrasonic data transmission. The button may be pressed or activated through an outer cover protecting the wristret, and the outer cover may indicate where the button can be pressed by pattern, color, etc.

[0298] The listret may also include one or more sensors, as well as a processing device 01183 for receiving and / or encoding information from the 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, the information may be encoded to indicate which data is included.

[0299] The system may also include one or more memory modules (not shown) 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 have the ability to both transmit and receive ultrasonic signals. Thus, bidirectional ultrasonic communication may be possible between the device and an observation station (e.g., a smartphone running control logic).

[0300] The ristretto may also include a power management system, typically comprising a rechargeable battery 01182. The battery may be relatively low power (e.g., low voltage such as 1.5V) and sufficient to power the electronic device and ultrasonic transducer. The processing device may manage the power, including charging the battery. The system may indicate when the battery is low and requires charging (e.g., by vibration of a warning vibration pattern).

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

[0302] For example, a wristlet device (e.g., an activity monitor) may be worn by a subject. Once worn, the device may record the wearer's movements (activity). The device may also include additional sensors, such as pairs 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 the outer surface of electrode 1. In some variations, pressing may cause the device to record electrical potentials for the duration of this period. The recorded electrical signals may contain information about the heart rate and ECG, which may be transmitted directly or first analyzed by a processing device before being transmitted (including transmitting any analyzed information).

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

[0304] In general, any of the techniques, components, and / or subsystems described above may be used with or in combination 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-detecting wristwatch Another variation of the ECG measurement device, configured to detect an ECG signal and transmit an ultrasonic signal that encodes ECG data, is shown in Figures 29 and 30. In this example, the watch is modified to include two electrodes. The first electrode (not visible in Figures 29 and 30) is located on the back of the watch ("wristlet") and contacts the wrist of the person wearing the device. The second electrode 01203 is located on the "front" of the watch 01201, as shown in Figure 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 on the side of the watch or strap area, for example, which may be held against the subject's leg (right leg or left leg) to produce additional / alternative leads (e.g., lead II, lead III, etc.).

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

[0307] Figure 30 shows a variation of the ECG device 01203 shown in Figure 29, which transmits 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 ECG watching and to receive ultrasonic transmissions of ECG information. Thus, the smartphone runs application software so that the smartphone's processing device "hears" the ultrasonic signal to an audio receiver (microphone) that senses ultrasound. The receiving device (smartphone) then processes the signal and may display it in real time as the ECG signal is recorded, as shown in Figure 30. In this example, the smartphone continuously receives, displays, and records the signal.

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

[0309] In some variations, as discussed above, the watch may determine / confirm that the receiving device (e.g., a smartphone) is ready to receive the information. In some variations, half-duplex or full-duplex may be used. The watch may broadcast ECG data continuously or transmit only when it indicates that the receiver 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. Furthermore, the signal may be encoded. In some variations, as discussed above, the device includes a key that can be scanned by the smartphone (receiver) to provide decoding / pairing between the device and the smartphone.

[0311] Many of the exemplary devices described herein are wearable devices (e.g., wristlets, chestbands, pendants, jewelry, etc.), but 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 embodiments, such as encoding ultrasonic signals or encoding as a hybrid digital / analog ultrasonic signal. 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 also be directly in contact with the other feature or element, or there may be intervening features and / or elements. 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. When a feature or element is referred to as "connected," "attached," or "joined" to another feature or element, it will also be understood that it may be directly connected to, attached to, or joined to the other feature or element, or there may be intervening features or elements. In contrast, when a feature or element is referred to as "directly connected," "directly attached," or "directly joined" to another feature or element, there are no intervening features or elements. Features and elements described or shown in reference to one embodiment may also apply to other embodiments. It will also be understood by those skilled in the art that references to structures or features positioned "adjacent" to other features may have overlapping portions with, or underlying portions of, the adjacent features.

[0313] The terms used herein are intended to describe only specific embodiments and are not intended to limit the invention. For example, when used herein, the singular forms “a,” “an,” and “the” are intended to include the plural form unless the context otherwise explicitly indicates. When used herein, the terms “equipped with” and / or “equipped with” specify the presence of the described feature, step, action, element, and / or component, but it will be further understood that this does not exclude the presence or addition of one or more other features, step, action, element, component, and / or group thereof. When used herein, the terms “and / or” include all combinations of one or more of the related enumerated items and may be abbreviated as “ / ”.

[0314] To describe the relationship between one element or feature and another element or feature shown in a diagram, spatially relative terms such as “under,” “below,” “lower,” “over,” and “upper” may be used herein for the sake of clarity. It will be understood that spatially relative terms are intended to encompass various orientations of a device in use or operation, in addition to the orientation shown in the diagram. For example, if the device in the diagram is reversed, an element described as being “under” or “beneath” another element or feature will be oriented “over” the other element or feature. Thus, the exemplary term “under” may encompass both over and under orientations. The device may be oriented differently (rotated 90 degrees, or in other orientations), and the spatially relative descriptors used herein will be interpreted accordingly. Similarly, terms such as “upwardly,” “downwardly,” “vertical,” and “horizontal” are used herein solely for illustrative purposes unless otherwise explicitly stated.

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

[0316] When used in this specification and in the claims, including when used in the examples, all numbers may be read as if preceded by the words “about” or “approximately,” even if those words are not explicitly present, unless otherwise expressly specified. The words “about” or “approximately” may be used when describing magnitude and / or location to indicate that the value and / or location described falls within a reasonably expected range of values ​​and / or locations. For example, a number may have values ​​such as + / -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 that are encompassed 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 given merely as examples. Without departing from the present invention, those skilled in the art will now recall numerous variations, modifications, and substitutions. It should be understood that various alternative forms of the embodiments of the present invention described herein may be used in practicing the invention. The following claims define the scope of the present invention, and methods and structures within the scope of these claims and their equivalents are intended to be encompassed by the claims.

[0318] Figure 31 is a flowchart of Method 3101 for performing a 12-inductance ECG with a 3-electrode device, according to some embodiments of the present disclosure. Method 3101 may be performed by processing logic comprising hardware (e.g., circuits, 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 in Figures 1 to 30 may perform one or more of the following operations. For example, in one embodiment, the processing logic of processing device 1110 performs the following operations with respect to the individual components in Figures 1 to 30. In another embodiment, any other suitable processing device may perform the operations described.

[0319] Referring to Figure 31, in block 3103, the processing logic may determine lead I (value) from a first electrical signal from a first electrode and a second electrical signal from a 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 in contact with the user's first upper limb and a second electrode in contact with the user's second upper limb. In block 3105, the processing logic may determine lead II from a 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 in contact with the user's second upper limb and a third electrode in contact with the user's first lower limb. In one embodiment, lead I and lead II are measured sequentially (for example, the user first places the electrode for lead I and obtains the measurement result, then places the electrode for lead II and obtains the corresponding measurement result). In such cases, the processing logic may further align lead I and lead II in time. In another embodiment, lead I and lead II are measured simultaneously (for example, the user places electrodes for lead I and lead II and obtains both measurement results contemporaneously, concurrently, or substantially simultaneously).

[0320] In block 3107, the processing logic may generate lead III (for example, using (lead III = lead II - lead I)). In another embodiment, lead III may be generated directly from the electrical signal of the electrode in contact with the user. In block 3109, the processing logic may determine leads aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 based on leads I, lead II, and lead III by the processing device using a machine learning model trained with measured 12-lead ECG data. In one embodiment, only data for leads I, II, and III are provided to the machine learning model, and the machine learning model uses only the data for leads I, II, and III to provide a 12-lead output. In another embodiment, additional data may be used by the model, as described below with respect to Figure 32.

[0321] In another embodiment, the processing logic may determine leads aVR, aVL, and aVF from leads I and II using non-machine learning-based techniques. In yet another embodiment, the processing logic may further determine the V leads from a 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 be used by the processing device to determine the leads and the remaining V leads based on leads I, leads II, leads III, and V leads using a machine learning model trained with measured 12-lead ECG data.

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

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

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

[0325] In one embodiment, the model is trained using a large, labeled training set with many epochs. To prevent overfitting and increase generality, random connection exclusion and batch normalization may be used. 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 verification. The dataset is first formed using an existing 12-lead diagnostic ECG database. Then, a second dataset is formed using ECGs actually sampled from the target device described here. Transfer learning can be used to tune only a few layers of the deep learning model for the second dataset.

[0326] Figure 32 is a flowchart of Method 3201 for machine learning training of a 12-lead ECG with a 3-electrode device, according to some embodiments of the present disclosure. Method 3201 may be executed by processing logic comprising hardware (e.g., circuits, 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, the processing logic corresponding to one or more components or methods in Figures 1 to 30 may perform one or more of the following operations. For example, in one embodiment, the processing logic of processing device 1110 performs the following operations with respect to the individual components in Figures 1 to 30. In another embodiment, any other suitable processing device may perform the operations described.

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

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

[0329] In one embodiment, for example, by performing one or more machine learning operations, features of 12-lead data may be selected, extracted, and labeled to predict a 12-lead ECG from three reads in real time. Such operations may be selected from those of ranking features, classifying features, labeling features, predicting features, and grouping features. 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, an operation may be selected from any of the operations described above. Any number of machine learning algorithms or methods may be trained to predict a 12-lead ECG from three reads. These may include the use of decision tree learning, such as random forests, correlation rule learning, artificial neural networks, inductive logic programming, support vector machines, clustering, Bayesian networks, reinforcement learning, representation learning, similarity and distance learning, and sparse dictionary learning.

[0330] A machine learning-based algorithm or operation for predicting a 12-lead ECG from three reads may be provided as a service from a remote server that can interact with or communicate with a client program, such as a mobile app, delivered on the user's computing device. This interaction or communication may occur through an Application Programming Interface (API). The API may provide access to machine learning operations, for example, for ranking, grouping, classifying, and predicting 12-lead ECGs from three reads.

[0331] Machine learning-based algorithms or operations, delivered via a remote server and / or on a local application on a local computing device, can, for example, operate on 12-lead and / or 3-lead data from a group of users, learn from them, and make analytical predictions from them.

[0332] The comparisons and analyses described herein can be used to derive conclusions and insights about a patient's health status, including health problems the patient may experience at the time of measurement or in the future. Conclusions and decisions may predict future health conditions or diagnose conditions the patient already has. Conclusions and decisions may also include insights into the effectiveness or risks associated with drugs or treatments the patient may be taking, may have taken, or may be considering taking. In addition, comparisons and analyses may be used to determine actions and activities that may reduce or increase the risk of adverse events. Based on the comparisons and analyses described herein, ECG data may be classified according to the level of risk at which adverse events are present. For example, ECG data may be classified as normal, low-risk, medium-risk, high-risk, and / or abnormal. The designation of normal and abnormal may require assessment, diagnosis, and / or confirmation by a healthcare professional.

[0333] Diagnoses and decisions of abnormalities, adverse events, or disease states made by physicians and other healthcare professionals may be transmitted to servers and databases, tagged with corresponding ECG data, and associated with it. Diagnoses and decisions may be made based on analysis of ECG data or using other testing or investigation procedures. Professional diagnoses and decisions may be extracted from the patient's electronic health record, entered into the system by the patient, or entered into the system by the healthcare professional. System conclusions and decisions may be compared to actual diagnoses and decisions made by healthcare professionals to validate and / or improve the machine learning algorithms used by the system. The time and duration of the occurrence of the abnormality, adverse event, or disease state may also be included in the database so that the ECG data corresponding to its occurrence, as well as ECG data before and / or after the abnormality, adverse event, or disease state, can be correlated and analyzed together. The length of time before or after the abnormality may be predetermined, ranging from a maximum of 1 to 30 days, or from 1 to 12 months or longer. Analysis of data prior to an abnormality, adverse event, or disease state may allow the system to identify patterns or correlations of various ECG features preceding the onset of the abnormality, adverse event, or disease state, thereby enabling the early detection or warning of the abnormality, adverse event, or disease state. Analysis of data after an abnormality, adverse event, or disease state may provide information regarding the effectiveness of treatment and / or information regarding the progression of the disease, such as whether the patient's condition is improving, worsening, or remaining the same. Diagnosis and decision-making may also be used for indexing, for example, by including it in 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, activity, food consumption, beverage consumption, drugs, medical history, and other factors that may affect the patient's ECG signal. Additional parameters may or may not be used in comparisons of changes in the ECG signal over time and under different circumstances.

[0335] Conclusions, decisions, and / or insights about a patient's health generated by the system may be communicated to the patient directly or through the patient's caregiver (a physician or other healthcare professional). For example, the patient may receive an email or text message automatically generated by the system. The email or text message may be a notification instructing the patient to log in to a secure site to retrieve the full conclusions, decisions, or insights, or it may contain the conclusions, decisions, or insights. Alternatively or additionally, the email or text message may be sent to the patient's caregiver. Notifications may also be delivered via an application on a smartphone, tablet, laptop, desktop, or other computing device.

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

[0337] 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, retrieved, and / or classified according to any of the features, parameters, or criteria described herein. The system may analyze ECG data from a single patient, or it may analyze ECG data from a group of patients, and the group of patients may be selected according to any of the features, 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 ECG data so that a comparison of one set of ECG data taken at a particular time with another set of ECG data taken at a different time reveals differences due to changes in health status, rather than changes in the type of ECG recording device used, changes in lead and electrode placement, or changes in skin condition (i.e., dry, sweaty, with or without conductive gel). As described above, consistent lead and electrode placement can help reduce variability in ECG measurements. The system can also retrieve ECG data from patients taken under similar circumstances and analyze this subset of 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 Remote communication device 0427 Client Control Logic 0429 Audio Pickup 0431 Source Device 0433 Data Entry 01005 Microcontroller 01007 Ultrasonic Transducer 01025 Remote communication device 01027 Client Control Logic 01029 Audio Pickup 01031 Source Device 01033 Input 01033 Ultrasonic Transducer 01051 encryption key 01053 Enter encryption key 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 Remote Communication Device 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 processors 1230 Local Interface 1235 Connection 2100 Smartphone 2110 Front 2120 yen 2130 Back 2140 displays 2200 Smartphone Protective Case 2210 Electrode 2220 Electrode 2230 Electrode 3100 Tablet Computer 3110 Front 3120 yen 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. A set of electrodes configured to measure a first electrical signal, a second electrical signal, a third electrical signal, and a fourth electrical signal of a user, wherein the set of electrodes consists of three electrodes, and each of the first, second, third, and fourth electrical signals is measured by selectively using an electrode from the set of electrodes; Based on the first electrical signal and the second electrical signal, the lead I is determined. Lead II is determined based on the second and third electrical signals. Based on the aforementioned lead II and lead I, lead III is generated. A first V lead is generated from a set of V leads based at least partially on the fourth electrical signal, Using a machine learning model trained with measured 12-lead ECG data, the remaining V leads in the set of leads aVR, aVL, aVF, and V leads are determined based on leads I, II, and III. The set of reads I, II, III, aVR, aVL, aVF, and V are provided for display on a client device. A processing device configured as follows: An apparatus in which the lead I and the lead II are determined in sequence, and the processing device further aligns the lead I and the lead II in time.

2. The apparatus according to claim 1, wherein the processing device is further configured to train the machine learning model using the measured 12-lead ECG data.

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

4. The apparatus according to claim 3, wherein the processing device is further configured to preprocess the measured 12-lead ECG data based on the user's characteristics.

5. The apparatus according to claim 1, wherein the processing device is further configured to train the machine learning model using only a portion of the measured 12-lead ECG data corresponding to the user.

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