12-lead electrocardiogram using a three-electrode setup

Abstract

An electrocardiogram (ECG) device includes a first electrode assembly, a second electrode assembly, and a third electrode assembly, each having a first electrode, a second electrode, and a third electrode, respectively, adapted to measure a first electrical signal, a second electrical signal, and a third electrical signal of an individual. The device also includes a processing device configured to: determine Lead I based on the first electrical signal and the second electrical signal; determine Lead II based on the second electrical signal and the third electrical signal; generate Lead III using (Lead III = Lead II - Lead I); determine Leads aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 based on Lead I, Lead II, and Lead III using a machine learning model trained using measured 12-lead ECG data; and provide the Leads, namely, Lead I, Lead II, Lead III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6, for display on a client device.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 946,331, filed December 10, 2019, and U.S. Non-Provisional Application No. 17 / 116,905, filed December 9, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates to consumer and medical devices, systems, and methods. In particular, the present invention relates to personal physiological monitoring devices and related systems and methods, and more particularly to such devices, systems, and methods for providing electrocardiogram (ECG), heart rate, and arrhythmia monitoring using a computing device such as a personal computer, laptop computer, tablet computer, smartphone, or wearable computing device. Background Art

[0004] Cardiovascular disease is the leading cause of death worldwide. In 2008, 30% of all global deaths were attributable to cardiovascular disease. It is estimated that by 2030, more than 23 million people will die annually from cardiovascular disease. Cardiovascular disease is prevalent in both high-income and low-income countries.

[0005] Arrhythmias are heart conditions in which the heart's electrical activity is irregular, either faster (tachycardia) or slower (bradycardia) than normal. While many arrhythmias are not life-threatening, some can lead to cardiac arrest or even sudden cardiac death. In fact, arrhythmias are one of the most common causes of death in hospital admissions. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] The novel features of the present invention are particularly set forth in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description of illustrative embodiments that illustrate the principles of the present invention and the accompanying drawings, in which:

[0007] Figure 1 A schematic diagram illustrating a system for measuring and monitoring a biometric or physiological parameter, according to many embodiments;

[0008] Figures 2A to 2K shows a biometric or physiological parameter measurement and monitoring system including a smartphone and a protective smartphone case in accordance with many embodiments;

[0009] Figures 3A to 3F shows a biometric or physiological parameter measurement and monitoring system including a tablet computer and a protective tablet computer housing according to many embodiments;

[0010] Figures 4A to 4Cshows a biometric or physiological parameter measurement and monitoring system including a keyboard and keyboard accessories for a computing device, according to many embodiments;

[0011] Figures 5A to 5C shows a biometric or physiological parameter measurement and monitoring system including a laptop or palmtop computer and a sensor assembly according to many embodiments;

[0012] Figure 6 Methods for biometric or physiological parameter measurement and monitoring according to many embodiments are shown;

[0013] Figure 7 is a diagram of the body showing examples of electrode placement for performing a standard 12-lead ECG;

[0014] Figure 8 is a diagram of a chest showing an example of electrode placement on the chest for performing a 12-lead ECG (illustrating the positioning of V6-V12);

[0015] Figure 9A a front view showing one variation of an apparatus as described herein (wherein, in this example, a wireless mobile telecommunications device is shown inserted into an apparatus configured as a housing);

[0016] Figure 9B 、 Figure 9C and Figure 9D Shown separately Figure 9A Left side view, rear view and right side view of the device;

[0017] Figure 10A is a front view of another variation of the apparatus as described herein, configured as a housing shown empty but adapted to hold a mobile telecommunications device;

[0018] FIG. 10B to FIG. 10D Shown separately Figure 4A Left side view, back view and right side view of the device (in this example, the leg (first) electrode is on the left side of the housing);

[0019] Figures 11A to 11C illustrates another variation of a device as described herein (in this example, the leg (first) electrodes are on the edge between the rear and left sides of the housing) from left, rear, and right side views, respectively;

[0020] 12A to 12C illustrates another variation of a device as described herein from left, rear, and right side views, respectively (in this example, the leg (first) electrode is on the rear surface, adjacent to the left side);

[0021] 13A to 13Cillustrates another variation of a device as described herein (in this example, the leg (first) electrodes are on the edge between the rear and left sides of the housing) from left, rear, and right side views, respectively;

[0022] 14A to 14C illustrating another variation of a device as described herein from left, rear, and right side views, respectively (in this example, the left (first) electrode is on the left side of the housing, and the second and third electrodes are part of an electrode unit held by the housing on the rear surface);

[0023] Figures 15A to 15C illustrates another variation of a device as described herein (in this example, the leg (first) electrode is located between the second and third electrodes on the rear surface) from left, rear, and right side views, respectively;

[0024] 16A to 16B illustrates another variation of an apparatus as described herein (in this example, the leg (first) electrode is on a cord extendable from the body of the device for attachment to the leg) from left, rear, and right side views, respectively;

[0025] Figure 17 Illustrating the use of one variation of the device described herein for detecting an ECG, which is held against a patient's leg so that the leg electrodes contact the leg while the patient's hand contacts the left and right electrodes, respectively, on the back of the device;

[0026] Figure 18 This is a diagram of the human hearing range and threshold from http: / / en.labs.wikimedia.org / wiki / Acoustics;

[0027] Figure 19 This graphic depicts hearing loss with age, taken from www.neuroreille.com / promenade / english / audiometry / audiometry.htm;

[0028] Figure 20 is an audiogram showing the intensity and frequency of common sounds from www.hearinglossky.org / hlasurvivall.html;

[0029] Figure 21A is a schematic diagram of a system configured to ultrasonically transmit digital data encoding one or more biometric parameters to a telecommunications device such as a smartphone;

[0030] Figure 21Bis a schematic diagram of a system including a medical sensing device configured to ultrasonically transmit data encoding one or more biological parameters to a telecommunication device such as a smartphone;

[0031] Figure 21C 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) using ultrasound to a telecommunication device such as a smartphone;

[0032] Figure 22 shows a variation of a digital signal that has been encoded using frequency shift keying in the ultrasound range as described;

[0033] Figure 23 is an exemplary flow chart illustrating one method of transmitting encoded data as an ultrasound signal;

[0034] Figures 24A to 24E is an exemplary flow chart of a method for transmitting a signal (e.g., packet transmission) as an ultrasound signal;

[0035] Figure 25 An example of a flow diagram illustrating a demodulator and packet decoder for use in a receiver configured to receive and decode data transmitted using ultrasound as discussed herein;

[0036] Figure 26A An exemplary format of mixed digital and analog ultrasound data format is shown;

[0037] Figure 26B Another exemplary format showing a mixed digital and analog ultrasound data format;

[0038] Figure 27 is a schematic diagram of a system for secure ultrasonic transmission of data, the system comprising an ultrasonic communication device having an ultrasonic transducer, and an encryption key located on the ultrasonic communication device and decrypting logic executable on a telecommunications device, wherein the telecommunications device includes a receiver for receiving ultrasonic signals from the ultrasonic communication device;

[0039] Figure 28A and Figure 28B Illustrate a variation of a wristband device for sensing one or more bio-parameters and for wirelessly transmitting the one or more bio-parameters to a mobile communication / computing device at very low power ( Figure 28A The appearance of the wristband is shown in FIG. Figure 28B A schematic diagram illustrating the internal area including various modules for sensing, powering, and transmitting ultrasound signals, and many of these elements are optional);

[0040] Figure 29 A variation of a wristband showing a watch configured to detect ECG signals;

[0041] Figure 30 Show Figure 29 The wristband communicates (via ultrasound) with a mobile telecommunications device to transmit ECG information;

[0042] Figure 31 is a flow chart of a method for performing a 12-lead ECG using a three-electrode arrangement according to some embodiments of the present invention;

[0043] Figure 32 is a flow chart of a method for machine learning training of 12-lead ECG using a three-electrode setup according to some embodiments of the present invention. DETAILED DESCRIPTION

[0044] Disclosed are devices, systems, and methods for measuring and monitoring biometric or physiological parameters in a user-friendly and convenient manner.

[0045] It should be understood that the present invention is not limited in its application to the details of the configuration, experiments, exemplary data and / or arrangement of components set forth in the following description. The invention of the present invention is capable of other embodiments or can be practiced or carried out in various ways. In addition, it should be understood that the terminology employed herein is for descriptive purposes only and should not be considered as limiting.

[0046] In the following detailed description of embodiments of the present invention, numerous specific details are set forth to provide a more thorough understanding of the present invention. However, it will be apparent to one of ordinary skill in the art that the concepts within the present invention may be practiced without these specific details. In other instances, well-known features have not been described in detail to avoid unnecessarily complicating the description.

[0047] Atrial fibrillation (A-fib) is the most common heart rhythm disorder. In A-fib, electrical conduction through the heart's ventricles is irregular and chaotic. Although A-fib may not cause symptoms, A-fib is often associated with palpitations, shortness of breath, fainting, chest pain or congestive heart failure, and also increases the risk of stroke. A-fib is usually diagnosed by capturing an electrocardiogram (ECG) of the subject. To treat A-fib, patients can take medication to slow their heart rate or change the heart's rhythm. Patients can also take anticoagulants to prevent stroke, or can even undergo surgical intervention including cardiac ablation to treat A-fib.

[0048] Typically, patients with arrhythmias or A-fib are monitored for extended periods of time to manage the disease. For example, patients may be given a Holter monitor or other dynamic electrocardiography device to continuously monitor the electrical activity of the cardiovascular system for at least 24 hours.

[0049] Electrocardiography is used to study the electrical activity of the heart and can be used for both diagnosis and treatment. Electrodes placed at multiple locations on the patient's skin can be used to record or capture an electrocardiogram (ECG). The electrical signals recorded between the electrode pairs are called leads. Different numbers of leads can be used to capture an ECG, and different combinations of electrodes can be used to form various leads. Examples of leads used to capture an ECG are 1, 3, 5, and 12 leads. For a 12-lead ECG, 10 electrodes can be used, with six electrodes on the chest and one electrode on each of the patient's arms and legs.

[0050] There are different "standard" configurations for electrode placement that can be used to place electrodes on a patient. For example, arm and leg electrodes can be placed closer to the chest or closer to the ends of the arms / legs. Variations in electrode placement on the arms and legs can affect the ECG and make comparisons with standard ECGs more difficult.

[0051] The standard or conventional 12-lead ECG configuration uses 10 electrodes. Figure 1 A diagram illustrating 10 electrodes, six of which are on the patient's chest, and one electrode each on the patient's arm and leg. The electrode placed on the right arm can be referred to as RA. The electrode placed on the left arm can be referred to as LA. The RA and LA electrodes are placed in the same location on the left and right arms (preferably near the wrist). The leg electrode can be referred to as RL for the right leg and LL for the left leg. The RL and LL electrodes are placed in the same location on the left and right legs (preferably near the ankle).

[0052] In another embodiment, a 12-lead ECG can be generated using three electrodes (e.g., using a device including three electrodes). For example, in one embodiment, a device with three electrodes as described herein can be used to determine Lead I (e.g., the voltage between the left and right arms) simultaneously with Lead II (e.g., the voltage between the left leg and the right arm), and Lead I simultaneously with Lead V2 or another of the chest leads (such as V5, etc.). In other embodiments, any other combination of leads is possible. Processing logic can then time-align the two sets of recordings using Lead I or another lead that is common to the measurements so that the two sets of measurements can be compared over the same simulated time period.

[0053] The processing logic may further transform the two sets of leads to generate a complete 12-lead ECG. In one embodiment, the processing logic may use a machine learning model (e.g., a neural network, deep learning techniques, etc.) to perform this transformation. The machine learning model may be trained using 12-lead ECG data corresponding to a population of individuals. The data may be pre-processed before being input into the machine learning model to filter the data in a manner suitable for the application. For example, the data may be classified according to height, gender, weight, nationality, etc. before being used to train one or more machine learning models, so that the one or more models thus obtained are fine-tuned for a particular type of individual. In another embodiment, the machine learning model may be further trained based on the user's own ECG data to further fine-tune and personalize the model to reduce any residual integrated errors.

[0054] In one embodiment, using the machine learning techniques described herein, a full 12-lead ECG can be generated using only three electrodes in a single form factor. As described herein, the three electrodes can be positioned on the device in any suitable manner, including two electrodes on the front of the device and one electrode on the back.

[0055] Figure 7 and Figure 8 The placement of six electrodes on the chest (labeled V1, V2, V3, V4, V5, and V6) is illustrated. V1 is placed in the fourth intercostal space, for example, between ribs 4 and 5, just to the right of the sternum. V2 is placed in the fourth intercostal space, for example, 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 in the midclavicular line. V5 is placed horizontally in the left anterior axillary line, flush with V4. V6 is placed horizontally in the mid-axillary line, flush with V4 and V5.

[0056] Lead I is typically the voltage between the left arm (LA) and the right arm (RA), e.g., I = LA - RA. Lead II is typically the voltage between the left leg (LL) and the right arm (RA), e.g., II = LL - RA. Lead III is typically the voltage between the left leg (LL) and the left arm (LA), e.g., III = LL - LA. The Wilson Center Terminal (WCT or VW) can be calculated as (RA + LA + LL) / 3. Considering that both Leads I and II are recorded with reference to RA, so that the voltage of RA can be considered to be zero, WCT (VW) can be calculated as Lead I + Lead II / 3.

[0057] The augmented limb leads can also be determined based on 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.

[0058] I, II, III, aVR, aVL and aVF can all be represented on a six-axis system.Incorrect or offset electrode placement can offset the ECG results on a six-axis system.

[0059] However, current dynamic electrocardiography devices such as Holter monitors are typically bulky and difficult for the subject to use without the help of a medical professional. For example, the use of a Holter monitor requires the patient to wear a bulky device on their chest and to precisely place multiple electrodes at precise locations on their chest. These requirements may hinder the subject's activities, including their natural movement, bathing, and showering. Once a fully disclosed ECG is generated, the ECG is sent to the patient's doctor, who then analyzes the ECG and provides a diagnosis and other recommendations. Currently, this process typically must be carried out through hospital administrators and health management organizations, and many patients do not have convenient access to feedback.

[0060] Many handheld ECG measurement devices are known, including devices that can be adapted to existing mobile telecommunications devices (e.g., smartphones) so that these devices can be used to record ECGs. However, such devices require the use of external (e.g., plug-in) electrodes or include electrodes in a housing that is difficult to properly hold and apply to the body.

[0061] Wearable monitors for detecting one or more biometric parameters (including subject motion, heart rate, temperature, ECG, etc.) typically must communicate wirelessly with a monitoring, analyzing, or recording station ("monitoring station"). Typically, the transmission of information has been performed via short wavelength radio transmission (e.g., "Bluetooth"). It is worth noting that while some embodiments have been described with respect to ultrasonic communication, it is contemplated that Bluetooth communication is equally (if not more) applicable to the described technology, and that ultrasonic waves are presented merely as a non-limiting example of any number of other suitable communication technologies. It is expected that persons having reasonable skill in the art will recognize this.

[0062] In some cases 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 have chosen to record data rather than transmit it, and download the data periodically by connecting directly to a monitoring station. It would be advantageous to provide a monitoring device that can be worn by the subject on the wrist (e.g., a wristband) or other body area that can transmit data wirelessly reliably and with low energy.

[0063] For example, cardiac monitoring devices such as those described in U.S. Patent No. 4,221,223, U.S. Patent No. 4,295,472, and U.S. Patent No. 4,230,127 describe wristwatch-sized wearable monitors that can detect ECG signals from patients wearing the device; these signals can be displayed on the device. These signals are not transmitted. Other similar devices are described in U.S. Patent No. 4,938,228. U.S. Patent No. 5,351,695, U.S. Patent No. 5,333,616, U.S. Patent No. 5,317,269, and U.S. Patent No. 5,289,824 (all to Mils) describe improvements to the device that include an integrated hearing-aid type speaker for transmitting ECG signals over a telephone line using audible sound (e.g., between 1kHz and 3kHz) using sound on the voice channel of the phone. ECG signals are typically digitized and frequency modulated (e.g., as a frequency shift keyed signal). Unfortunately, such devices do generate noisy audible signals, require significant power to generate and transmit, and are incapable of two-way communication, particularly with mobile telecommunications devices.

[0064] The following patent references may also be relevant: US Patent No. 5,735,285, US Patent No. 6,264,614, US Patent No. 6,685,633, US Patent No. 6,790,178, US Patent No. 8,301,232, US Patent No. 8,509,882, and US Patent No. 8,615,290 and US Publication No. 2011 / 0015496.

[0065] Ultrasonic transmission has many similarities to electrical transmission, but there are also substantial differences, including differences that were previously considered disadvantages. In addition, although techniques such as frequency shift keying for digitizing information are known, it is difficult and impractical to implement such techniques on a time scale that would make them practical for medical (e.g., ECG) monitoring. In particular, the transmission of ultrasonic data has heretofore been somewhat limited in terms of information content. For example, digitally encoding information via ultrasound is limited in terms of the amount and content of the information transmitted. There are no standards for the transmission or encoding of ultrasonic transmissions. Furthermore, such ultrasonic signals are not routinely encrypted.

[0066] Therefore, it would be advantageous to provide systems, devices, and methods for encoding or arranging information sent via ultrasonic transmission. In particular, it would be advantageous to encode information in a manner that circumvents the limitations of ultrasonic (as opposed to electromagnetic or audible) transmission. Additionally, it would be helpful to provide methods, devices, and systems for securely transmitting (e.g., encrypting and / or decrypting) ultrasonic transmissions. For example, it would be helpful to dynamically pair a device (e.g., a wristband) that transmits ECG information ultrasonically with one or more receiving devices.

[0067] Described herein are methods, devices, and systems for using (or being adapted for use with) one or more widely available telecommunication devices (including mobile telecommunication devices) (such as smartphones, tablet computers, portable computers, or desktop computers, etc.) to receive and transmit information (including, but not limited to, digital health information) that has been encoded by an application device into an ultrasonic signal that can be heard by the telecommunication device and then stored, transmitted, and / or analyzed by the telecommunication device. In particular, described herein are methods, devices, and systems for encoding the information so that the information can only be deciphered by a telecommunication device that has been provided with a key. The systems, devices, and methods (including executable logic) may include techniques for easily providing keys using a modality different from ultrasonic transmission (e.g., optical).

[0068] U.S. Patent Application No. 12 / 796,188, filed June 8, 2010 (now U.S. Patent No. 8,509,882), entitled “HEART MONITORING SYSTEM USABLE WITH A SMARTPHONE OR COMPUTER,” and U.S. Patent Application No. 13 / 108,738, filed May 16, 2011 (now U.S. Patent Application Publication No. US / 2011 / 0301439-A1), entitled “WIRELESS, ULTRASONIC PERSONAL HEALTH MONITORING SYSTEM,” describe ECG monitors that convert ECG data into ultrasound signals that can be received by a telecommunications device, such as a smartphone, and then stored, analyzed, and / or displayed. The present application expands and adapts this teaching and can be used with any of the systems, methods, and devices described herein.

[0069]

[0006] Therefore, there is a need for improved cardiac disease and / or rhythm management and monitoring devices, systems, and methods that address one or more of the aforementioned challenges.

[0070] Disclosed are devices, systems, and methods for measuring and monitoring biometric or physiological parameters in a user-friendly and convenient manner. In particular, relevant physiological parameters of a user can be measured while the user is normally operating a computing device or other manually operated or handheld device. For example, the system of the present invention can enable one or more physiological parameters of a user to be measured while the user is normally operating a computing device such as a laptop computer, tablet computer, or smart phone. One or more physiological parameters can be measured using accessories of the computing device (such as a laptop computer case, tablet computer case, or smart phone case, etc.). Normal use of the computing device can include web browsing, reading and writing emails or text messages, playing games, or otherwise using other common applications (such as books or text readers, etc.). The physiological parameter monitoring and measurement application of the present invention can operate in the background during normal use of the computing device.

[0071] Aspects of the present invention provide a system for measuring a cardiac parameter of a user. The system may include a device configured to be coupled to a computing device and a first application loaded onto the computing device. The device may include a sensor for measuring the cardiac parameter. The first application may be configured to receive the measured cardiac parameter from the sensor. The sensor may measure the cardiac parameter, and the first application may receive the measured cardiac parameter while a second application is loaded onto the computing device and operated by the user.

[0072] The cardiac parameters may include one or more of heart rate, heart rate variability, blood pressure, blood pressure variability, arrhythmia, seismocardiogram (SCG), SCG parameters, electrocardiogram (ECG), and ECG parameters. In many embodiments, the cardiac parameters include an electrocardiogram (ECG) or ECG parameters.

[0073] The computing device may include one or more of a personal computer, a laptop computer, a tablet computer, a personal digital assistant (PDA), a smartphone, and a wearable computing device. In many embodiments, the computing device includes a tablet computer or a smartphone. The apparatus may be configured to be removably coupled to the computing device and may include a cover for covering the computing device, such as a tablet computer housing or a smartphone housing or cover.

[0074] A sensor for measuring a cardiac parameter may include a first electrode and a second electrode configured to generate a signal including the cardiac parameter when in 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 also include a third electrode configured to contact the user, configured to generate a signal including the cardiac parameter when in contact with the user. For example, the first, second, and third electrodes may be simultaneously used to generate one or more of Lead I, Lead II, and Lead III ECGs. 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.

[0075] The first application can also be configured to display the measured cardiac parameters, for example, on a display of the computing device. The cardiac parameters can be displayed in real time. The first application can also be configured to store the measured cardiac parameters in a memory of the computing device. The first application can also be configured to transmit the measured cardiac parameters to a remote computing device, such as a remote server. The remote computing device can store cardiac or other physiological parameter data and allow medical professionals and other professionals to access this data for data analysis, interpretation, and / or diagnosis. The analysis and diagnosis can be sent back to the user via the remote computing device and the user's computing device, or via 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, and another application used by the medical professional or professional can automatically generate such data analysis, interpretation, and / or diagnosis.

[0076] Manipulating the second application may include one or more of typing on the second application's keyboard, scrolling on the second application, zooming in or out in the second application, and otherwise inputting data into the second application. By allowing a user to manipulate the second application loaded on the computing device while the first application is measuring and monitoring the user's cardiac and other health parameters, embodiments of the present invention allow for user-friendly, convenient, and less invasive and disruptive measurement and monitoring of cardiac and other health parameters. For example, a user may hold and operate the computing device normally to check email, browse the web, or operate a mobile application while the first application and computing device cover are measuring and / or monitoring the user's ECG or other cardiac and physiological parameters in the background.

[0077] Aspects of the present invention also provide a method for measuring a cardiac parameter of a user. A device including a sensor for a cardiac parameter may be coupled to a computing device. The sensor may be used to measure the cardiac parameter of the user. The device may be used to transmit the measured cardiac parameter to a first application loaded on the computing device. The cardiac parameter may be measured, and the first application may receive the transmitted measured cardiac parameter while the user is operating a second application loaded on the computing device.

[0078] The cardiac parameters may include one or more of heart rate, heart rate variability, blood pressure, blood pressure variability, arrhythmia, seismocardiogram (SCG), SCG parameters, electrocardiogram (ECG), and ECG parameters. In many embodiments, the cardiac parameters include an electrocardiogram (ECG) or ECG parameters.

[0079] The computing device may include one or more of a personal computer, a laptop computer, a tablet computer, a personal digital assistant (PDA), a smartphone, and a wearable computing device. In many embodiments, the computing device includes a tablet computer or a smartphone. The device may be coupled to the computing device by removably attaching the device to the computing device. For example, the device may include a cover for covering the computing device, such as a tablet computer housing or a smartphone housing or cover. Furthermore, the method may include at least partially surrounding the computing device, such as a tablet computer or smartphone, with the housing or cover.

[0080] The sensor can be used to measure cardiac parameters by using first and second electrodes of the sensor. The first and second electrodes can be configured to generate a signal including the cardiac parameter when in contact with the user. For example, the first electrode can be configured to contact the user's right arm, and the second electrode can be configured to contact the user's left arm to generate a Lead I ECG. Alternatively, or in combination, the first electrode can be configured to contact the user's right arm, and the second electrode can be configured to contact the user's left leg to generate a Lead II ECG. Alternatively, or in combination, the first electrode can be configured to contact the user's left arm, and the second electrode can be configured to contact the user's left leg to generate a Lead III ECG. Cardiac parameters can also be measured using a third electrode of the sensor, which is configured to generate a signal including the cardiac parameter when in contact with the user. For example, the first, second, and third electrodes can be used simultaneously to generate one or more of Lead I ECG, Lead II ECG, and Lead III ECG. The first electrode can be configured to contact the user's right arm, the second electrode can be configured to contact the user's left arm, and the third electrode can be configured to contact the user's left leg.

[0081] Furthermore, the received measured cardiac parameters can be displayed on / using a display of the computing device. The cardiac parameters can be displayed in real time. Furthermore, the measured cardiac parameters can be stored in a memory of the computing device. The measured cardiac parameters can also be transmitted to a remote computing device, such as a remote server. The remote computing device can store cardiac or other physiological parameter data and allow medical professionals and other professionals to access this data for data analysis, interpretation, and / or diagnosis. The analysis and diagnosis can be sent back to the user via the remote computing device and the user's computing device, or via other channels such as email, text messaging, or other electronic alerts. Alternatively, or in combination, one or more of a first application loaded on the computing device, another application loaded on the remote server, and another application used by the medical professional or professional can automatically generate such data analysis, interpretation, and / or diagnosis.

[0082] Manipulation of the second application may include one or more of typing on the second application's keyboard, scrolling on the second application, zooming in or out in the second application, and otherwise entering data into the second application, among others. By allowing the user to manipulate the second application loaded on the computing device while the first application measures and monitors the user's (one or more) cardiac and other health parameters, embodiments of the present invention allow for user-friendly, convenient, and less invasive and disruptive measurement and monitoring of cardiac and other health parameters. For example, a user may hold and operate the computing device normally to check email, a web browser, or operate a mobile application while the first application and computing device cover measure and / or monitor the user's ECG or other cardiac and physiological parameters in the background. In some embodiments, if the health parameter sensor is incorrectly positioned such that a correct measurement is not possible or incapable, the first application may cause the computing device to alert the user (i.e., a pop-up window may be displayed in the second application).

[0083] Aspects of the present invention also provide a system for measuring a cardiac parameter of a user. The system may include a cover configured to be removably attached to a portable computing device. The portable computing device may include a front face, a back face, and an edge therebetween. The cover may include a plurality of sensor electrodes configured to measure cardiac parameters and arranged on the edge of the portable computing device when the cover is attached to the portable computing device. In many embodiments, the plurality of sensor electrodes are arranged only on the edge of the portable computing device. The portable computing device may include a laptop computer, a tablet computer, a personal digital assistant (PDA), or a smartphone.

[0084] The cardiac parameters may include one or more of heart rate, heart rate variability, blood pressure, blood pressure variability, arrhythmia, seismocardiogram (SCG), SCG parameters, electrocardiogram (ECG), and ECG parameters. In many embodiments, the cardiac parameters include an electrocardiogram (ECG) or ECG parameters.

[0085] The plurality of sensor electrodes may include a first sensor electrode and a second sensor electrode. The first sensor electrode and the second sensor electrode may be configured to generate a signal including a cardiac parameter when in contact with a first limb and a second limb of a 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 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 plurality of sensor electrodes may also include a third sensor electrode configured to generate a signal including a cardiac parameter when in contact with a third limb of the user. Cardiac parameters may also be measured using the third sensor electrode, which is configured to generate a signal including a cardiac parameter when in contact with the user. For example, the first, second, and third electrodes may be used simultaneously to generate one or more of Lead I, Lead II, and Lead III ECGs.

[0086] The system may also include a first application loaded onto the portable computing device. The first application may be configured to receive measured cardiac parameters from a plurality of sensor electrodes. The first application may receive the measured cardiac parameters while a second application is loaded onto the portable computing device and manipulated by a user. Manipulation of the second application may include one or more of typing on a keyboard of the second application, scrolling on the second application, zooming in or out in the second application, and otherwise entering data into the second application. By allowing a user to manipulate the second application loaded on the computing device while the first application measures and monitors the user's cardiac and other health parameters, embodiments of the present invention allow for user-friendly, convenient, and less invasive and disruptive measurement and monitoring of cardiac and other health parameters. For example, a user may hold and operate the computing device normally to check email, a web browser, or operate a mobile application while the first application and computing device cover measure and / or monitor the user's ECG or other cardiac and physiological parameters in the background.

[0087] The first application can be configured to display the received cardiac parameters on a display of the portable computing device. The received cardiac parameters can be displayed in real time. The first application can also be configured to store the measured cardiac parameters in a memory of the portable computing device. The first application can also be configured to transmit the measured cardiac parameters to a remote computing device, such as a remote server. The remote computing device can store cardiac or other physiological parameter data and allow medical professionals and other professionals to access this data for data analysis, interpretation, and / or diagnosis. The analysis and diagnosis can be transmitted back to the user via the remote computing device and the user's computing device, or via 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, and another application used by the medical professional or professional can automatically generate such data analysis, interpretation, and / or diagnosis.

[0088] Aspects of the present invention also provide a method for measuring a cardiac parameter of a user. A mask can be removably attached to a portable computing device. The portable computing device can include a front face, a back face, and an edge therebetween. First and second electrodes of the mask can contact a first limb and a second limb of the user, respectively, to generate a signal including the cardiac parameter. The first and second electrodes of the mask can be arranged on an edge of the portable computing device. In many embodiments, the plurality of sensor electrodes can be arranged only on an edge of the portable computing device. The portable computing device can include a laptop computer, a tablet computer, a personal digital assistant (PDA), or a smartphone.

[0089] The cardiac parameters may include one or more of heart rate, heart rate variability, blood pressure, blood pressure variability, arrhythmia, seismocardiogram (SCG), SCG parameters, electrocardiogram (ECG), and ECG parameters. In many embodiments, the cardiac parameters include an electrocardiogram (ECG) or ECG parameters.

[0090] The third electrode may contact a third limb of the user to generate a signal including cardiac parameters. The first limb may include the right arm, the second limb may include the left arm, and the third limb may include the left leg. These three limbs may be simultaneously contacted with the first electrode, the second electrode, and the third electrode, respectively, to simultaneously generate Lead I ECG, Lead II ECG, and Lead III ECG. Alternatively, the first electrode and the second electrode 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 Lead III ECG.

[0091] Alternatively or in combination, the first application can be loaded onto a tablet computer or smartphone. The first application can be configured to receive measured cardiac parameters from a plurality of sensor electrodes. The first application can receive the measured cardiac parameters while a second application is loaded onto the computing device and manipulated by the user. Manipulation of the second application can include one or more of typing on a keyboard of the second application, scrolling on the second application, zooming in or out in the second application, and otherwise entering data into the second application. By allowing a user to manipulate the second application loaded on the computing device while the first application measures and monitors the user's cardiac and other health parameters, embodiments of the present invention allow for user-friendly, convenient, and less invasive and disruptive measurement and monitoring of cardiac and other health parameters. For example, a user can hold and operate the computing device normally to check email, browse a web browser, or operate a mobile application while the first application and computing device cover are measuring and / or monitoring the user's ECG or other cardiac and physiological parameters in the background.

[0092] The received cardiac parameters can be displayed on a display of a tablet computer or smartphone using a first application. The received cardiac parameters can be displayed in real time. The measured cardiac parameters can be stored in a memory of a computing device. The measured cardiac parameters can be transmitted to a remote computing device, such as a remote server. The remote computing device can store cardiac or other physiological parameter data and allow medical professionals and other professionals to access this data for data analysis, interpretation, and / or diagnosis. The analysis and diagnosis can be sent back to the user via the remote computing device and the user's computing device, or via 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, and another application used by the medical professional or professional can automatically generate such data analysis, interpretation, and / or diagnosis.

[0093] Aspects of the present invention also provide a system for measuring cardiac parameters of a user. The system may include a sensor device and an application. The device may be configured to couple to a keyboard of a computing device, a steering wheel of a motor vehicle, or a handlebar of a bicycle, motorcycle, or exercise equipment such as a treadmill, elliptical trainer, or weightlifter, a seat, a chair, a pair of glasses, clothing, or the like. The device may include a sensor for measuring cardiac parameters. The device may be configured to receive measured cardiac parameters from the sensor when contacting, holding, or manipulating the keyboard of a computing device, the steering wheel of a motor vehicle, the handlebar of a bicycle, motorcycle, or exercise equipment. Other methods and systems for conveniently, non-invasively, and non-destructively measuring and monitoring cardiac and other physiological parameters while the user is normally operating a computing or other device that is in contact with the user's body are also contemplated.

[0094] The present invention also describes apparatus (including systems, software, and devices) and methods (including methods for using these apparatuses) for capturing electrocardiogram (ECG) information from a subject using an interface compatible with a mobile telecommunications device having three electrodes. Apparatus for detecting ECG is described herein that can address problems with currently available ECG sensing systems (including, but not limited to, those described above).

[0095] Generally, the devices (including apparatus and systems) and methods described herein are used to detect biological signals such as an electrocardiogram (ECG). In particular, the present invention describes a device for use with a mobile telecommunications device so that the mobile telecommunications device can receive biological signals measured directly from a patient. The device typically includes three or more electrodes (or exactly three electrodes) for receiving signals such as voltage or current from the patient's body. The device may also include a housing. The housing may be configured to hold or be directly connected to the mobile telecommunications device, such as a "housing". One or more electrodes may be positioned directly on the outer surface of the housing. The device may also include one or more transmitters for communicating sensing signals (including modified / processed versions of sensing signals) from the electrodes to the mobile telecommunications device. The mobile telecommunications device may be connected to the housing, for example, within or near a housing formed by the housing. In some variations, the device may include one or more processing devices for processing signals detected on the electrodes.

[0096] Any suitable transmitter (including wireless transmitters) may be used. In some variations, the wireless transmitter is an ultrasonic transmitter that may use inaudible ultrasound (e.g., >10 kHz, >12 kHz, >15 kHz, >18 kHz, >19 kHz) that may be received by a microphone on a mobile telecommunication device and transmitted and / or further processed by the mobile telecommunication device. Examples of such systems are described in U.S. Patent No. 8,301,232 and U.S. Patent Application Publication Nos. US / 2011 / 0301435 and US / 2011 / 0301439, and by PCT Application Publication No. PCT / US2013 / 023370 (each of which is incorporated herein by reference in its entirety).

[0097] The devices described herein can be configured so that they can be held by the patient using both hands against the patient's legs (e.g., left or right leg) to measure six "leads" (leads I-III and compression leads aVR, aVL, aVF) from the patient. In some variations, the device can be configured so that the patient can easily see the screen of the mobile telecommunication device while holding the device (enclosing the mobile telecommunication device) with both hands against the leg (right or left) to record isolated signals from the right arm, left arm, and right or left leg respectively. This will allow the patient to receive immediate visual feedback from the device while taking measurements, including providing guidance (using the mobile telecommunication device screen or audio output) to adjust or correct the contact or position of the electrodes, and / or displaying one or more ECG signals. Therefore, the device can be configured as described herein so that it can be easily held to allow different electronic readings from each arm (right, left) and leg (left or right), while still allowing the subject holding the device to observe the screen of the mobile telecommunication device coupled to the device.

[0098] Generally, a patient (as used herein) can be a human or non-human patient, including but not limited to animals (dogs, cats, horses, etc.). Thus, any device or method described herein can be used for veterinary purposes or be configured as a veterinary product.

[0099] Generally, a mobile telecommunications device may include any mobile telecommunications device, such as, but not limited to, a mobile (e.g., cellular) telephone or equivalent (including an iPhone™ or Droid™, etc.). A mobile telecommunications device may generally include a processing device or other computing module / device that can run software or hardware, etc., which includes machine-readable code configured to operate the device to receive and / or send information from the devices described herein. Such code may be provided with the described devices or separately from the described devices. A mobile telecommunications device may refer to (and include) a telephone or cellular telephone, a mobile phone, a smartphone, a handheld computer, a tablet computer, or a wearable computer, etc. The code may be referred to as software or application software ("app" or "application") and may be downloaded to the mobile telecommunications device from a remote location.

[0100] For example, an electrocardiogram (ECG) detection device for use with a wireless telecommunications device is described herein. In some variations, a device includes: a housing configured to be mounted on the telecommunications device, the housing having an outer rear surface, at least two outer side surfaces perpendicular to the rear surface, and a front area through which a display of the telecommunications device held in the housing is visible; a first electrode on or adjacent to one of the at least two outer side surfaces; a second electrode on the outer rear surface, the second electrode having an outer contact surface; and a third electrode on the outer rear surface, the third electrode having an outer contact surface, wherein the outer contact surfaces of the second and third electrodes are recessed relative to at least a portion of the outer rear surface such that when the housing is placed on a work surface with the outer rear surface facing the work surface, the outer contact surfaces of the second and third electrodes do not contact the work surface, and further wherein the second and third electrodes are arranged such that a 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 while holding the first electrode against their leg and can view the display of the telecommunications device held in the housing.

[0101] When the device is configured as a housing, the housing can be configured to hold the mobile telecommunications device within a cavity, or otherwise be applied to the mobile telecommunications device. Thus, the housing may include one or more inner surfaces 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 manipulated. For example, the housing may include a cut-out area or a transparent cover through which the mobile telecommunications device can be viewed. The electrodes may be mounted on the housing. The housing may also include one or more other openings for accessing controls, inputs, outputs or connection areas (e.g., jacks, plug-in sockets, etc.) of the mobile telecommunications device. Typically, the electrodes are arranged on the housing so that: (1) these electrodes are protected from contact with surfaces (particularly metal surfaces) when the device is not in use; and (2) these electrodes can be easily accessed by a patient holding the device against a leg to record from both arms (via the hand) and the leg simultaneously, while still easily viewing the screen. The housing may also house additional components, such as a transmitter as described above, a power source (e.g., a battery, solar power source, etc.), and / or processing means, or other circuitry for conditioning, amplifying, filtering, or otherwise modifying the signal(s) received by the electrodes, etc. In some variations, the device may be configured such that one of the electrodes (e.g., the second electrode or the third electrode) may serve as a reference electrode for the other two (or in some cases, more) electrodes.

[0102] In a variation, the housing may include one or more attachment areas for one or more electrodes. For example, the housing may include an opening on the back for connecting to an electrode unit that can be used with housings having different configurations (e.g., for assembling mobile telecommunications devices of different 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.

[0103] The second electrode and the third electrode are typically configured so that they can each be easily contacted by the patient's hand. For example, the second electrode can be positioned and sized so that the patient can touch the second electrode with his / her left hand when the patient is also touching the third electrode of appropriate shape and size with his / her right hand. For example, in some variations, the second electrode and the third electrode are entirely on the outer rear surface. The second electrode can be on the upper / left half of the back side of the housing (relative to the mobile telecommunications device), while the third electrode is located on the lower / right half of the back side of the housing. The second electrode and the third electrode can be separated by a gap that is sized and / or shaped to prevent overlap between contact with the left and right hands. Typically, the patient should only touch each electrode with one hand.

[0104] The second electrode and the third electrode can be formed of any suitable conductive material (including metals, alloys, etc.) and can be sized so that they can be easily contacted by one or more fingers (or palms) of a patient holding the device. In some variations, the second electrode and the third electrode are positioned symmetrically relative to each other relative to the center of the outer rear surface.

[0105] The first electrode can be configured so that while holding the housing and touching the second and third electrodes with the left and right hands, respectively, the first electrode can be easily held against the patient's leg. Therefore, in some variations, the first electrode is completely located on the side of the housing (e.g., on one of the at least two outer surfaces). Alternatively, the first electrode can be located on the rear surface of the housing, but extends along the edge so that when the edge of the housing is held against the leg, the first electrode can be held against the leg. Therefore, the first electrode can be on the rear surface, but adjacent to or in close proximity to the side surface (one of the at least two outer surfaces). In some variations, the first electrode bends from the rear surface of the housing to the side over the edge of the housing (e.g., along the edge of the housing). Therefore, the first electrode can extend over the edge between one of the outer surfaces and the outer rear surface. Any of these configurations can allow the housing of the mobile telecommunications device to be held at a certain angle relative to the patient's leg, so that the patient can make good contact with the leg while still holding the housing with both hands, contacting the second and third electrodes, and viewing the screen of the mobile telecommunications device.

[0106] Thus, typically, the first electrode can extend along all or a portion (e.g., > half) of the length of one side of the housing. If the first electrode is on or near an edge of the housing and extends along all or a majority (e.g., between about 100% and about 50%, between about 90% and about 60%, about 75%) of the edge of the housing, then the housing can be easily held against the leg and in contact as described and shown herein. For example, the outer side surfaces of the housing can be generally rectangular; the first electrode can be centered between the two short edges of one of the outer side surfaces and extend longitudinally in the direction of the long edge of one of the outer side surfaces. As described above, the first electrode can extend on or adjacent to the outer side surface for more than half the length of the outer side surface.

[0107] In some variations, the device has only three electrodes (eg, a first electrode, a second electrode, and a third electrode) on the outer surface of the housing.

[0108] Typically, the device can be configured so that when the device is placed downwardly on a work surface with the electrodes (the first electrode and / or the second electrode and the third electrode) facing the work surface, the electrodes do not contact the work surface. This allows the device to be placed downwardly on a metal surface, as is often found in hospitals or other medical environments, without creating a conductive path between the electrodes and thereby potentially causing discharge (and / or consuming power from the device). In some variations, the electrodes are recessed relative to the outer rear surface. For example, the electrodes can be recessed within the material forming the housing. Alternatively or additionally, the housing can include one or more protrusions that the housing can rest against when the rear surface is placed downwardly, thereby preventing one or more electrodes from contacting the surface. For example, the outer rear surface of the housing can include one or more "spacers" that are 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 the one or more spacers. Typically, a spacer can refer to a protrusion whose height from the rear surface relative to the rear surface of the device is greater than the height of the (one or more) electrodes. For example, the spacer may be a bump, island, strip, sheet, tab, etc., extending from the back surface (in some variations around (eg, fully or partially surrounding) the electrode).

[0109] Typically, the electrodes can have sufficient surface area to easily and reliably contact the patient's hand and / or leg. The first (leg) electrode can have a different shape or size than 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 the other electrodes.

[0110] As described above, any device described herein may include a transmitter for communicating with a wireless telecommunications device. The transmitter may generally be wireless, or the transmitter may be directly connected (plugged into) the wireless telecommunications device. Electromagnetic transmitters (including near-field transmitters, radio (RF) transmission, etc.), optical transmitters, or any other type of transmission may be used. In particular, ultrasonic transmitters are described herein that may be integrated into the device.

[0111] For example, the present invention describes an electrocardiogram (ECG) detection device for use with a wireless telecommunications device, the device comprising: a housing configured to be mounted on the telecommunications device, the housing having an outer rear surface, at least two outer side surfaces perpendicular to the rear surface, and a front area through which a screen of the telecommunications device held in the housing can be seen; a first electrode on or adjacent to one of the at least two outer side surfaces; a second electrode on the outer rear surface, the second electrode having an outer contact surface; a third electrode on the outer rear surface, the third electrode having an outer contact surface; and an ultrasonic transmitter configured to transmit signals sensed from the first electrode, the second electrode, and the third electrode to the wireless telecommunications device using ultrasound, wherein the outer contact surfaces of the second electrode and the third electrode are recessed relative to at least a portion of the outer rear surface so that when the housing is placed on a workbench surface with the outer rear surface facing the workbench surface, the outer contact surfaces of the second electrode and the third electrode do not contact the workbench surface.

[0112] Also described herein are methods of using any of the described devices. For example, described herein is a method of generating an electrocardiogram (ECG) from a patient using a handheld wireless telecommunication device housing having three electrodes on an outer surface of the housing, the method comprising: instructing the patient to hold a first electrode extending along a side of the housing against a leg while touching a second electrode on the back of the housing with a right hand and a third electrode on the back of the housing with a left hand, such that the patient contacts no more than three electrodes on the housing; 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.

[0113] The present invention also describes a method for generating an electrocardiogram (ECG) from a patient using a handheld wireless telecommunication device housing having three electrodes on an outer surface of the housing, the method comprising: instructing the patient to hold a first electrode of the housing against a leg while touching a second electrode with the right hand and a third electrode with the left hand, such that the patient contacts no more than three electrodes on the housing; 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 housing to the telecommunication device using ultrasound.

[0114] Aspects of the present invention also provide an electrocardiogram (ECG) detection device for use with a wireless telecommunications device. The device may include a housing configured to be mounted on the telecommunications device. The housing may have an outer rear surface, at least two outer side surfaces perpendicular to the rear surface, and a front area through which a display of the telecommunications device held in the housing can be viewed. The device may also include a first electrode on or adjacent to one of the at least two outer side surfaces, a second electrode on the outer rear surface and having an outer contact surface, and a third electrode on the outer rear surface and having an outer contact surface. The outer contact surfaces of the second and third electrodes may be recessed relative to at least a portion of the outer rear surface so that when the housing is placed on a work surface with the outer rear surface facing the work surface, the outer contact surfaces of the second and third electrodes do not contact the work surface. In addition, the second and third electrodes may be arranged so that the patient can touch the outer contact surface of the second electrode with only the left hand and the outer contact surface of the third electrode with only the right hand while holding the first electrode against the leg, and can view the display of the telecommunications device held in the housing.

[0115] The second electrode and the third electrode may be entirely on the outer rear surface. The first electrode may be entirely on one of the at least two outer surfaces. The first electrode may be located on the outer rear surface in close proximity to one of the at least two outer surfaces. The first electrode may extend on an edge between one of the outer surfaces and the outer rear surface. The outer surfaces may each be rectangular, and the first electrode may be centered between the two short edges of one of the outer surfaces and may extend longitudinally in the direction of the long edge of one of the outer surfaces. The first electrode may extend on the outer surface or adjacent to the outer surface for more than half the length of the outer surface. The second electrode and the third electrode may be positioned symmetrically relative to each other relative to the center of the outer rear surface. The second electrode and the third electrode may be portions of the electrode unit that are assembled within an opening in the outer rear surface of the housing. The first electrode may have a surface area that is approximately the same as the surface area of the second electrode or the third electrode.

[0116] The device may include only three electrodes on an outer surface of the housing. The outer rear surface of the housing may include one or more spacers, the one or more spacers being 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 surface of the one or more spacers.

[0117] The apparatus may further include an ultrasonic transmitter configured to ultrasonically transmit signals sensed from the first electrode, the second electrode, and the third electrode to the wireless telecommunication device.

[0118] Aspects of the present invention also provide an electrocardiogram (ECG) detection device for use with a wireless telecommunications device. The device may include a housing configured to be mounted on a telecommunications device. The housing may have an outer rear surface, at least two outer side surfaces perpendicular to the rear surface, and a front area through which a screen of the telecommunications device held in the housing can be seen. The device may also include: a first electrode on or adjacent to one of the at least two outer side surfaces; a second electrode on the outer rear surface and having an outer contact surface; a third electrode on the outer rear surface and having an outer contact surface; and an ultrasonic transmitter configured to wirelessly (e.g., using ultrasound) transmit signals sensed from the first electrode, the second electrode, and the third electrode to the wireless telecommunications device. The outer contact surfaces of the second and third electrodes may be recessed relative to at least a portion of the outer rear surface so that when the housing is placed on a work surface with the outer rear surface facing the work surface, the outer contact surfaces of the second and third electrodes do not contact the work surface.

[0119] Aspects of the present invention also provide a method for generating an electrocardiogram (ECG) from a patient using a handheld wireless telecommunication device housing having three electrodes on an outer surface of the housing. The patient can be instructed to hold a first electrode extending along the side of the housing against a leg while touching a second electrode on the back of the housing with the right hand and a third electrode on the back of the housing with the left hand, such that the patient contacts no more than three electrodes on the housing. A first lead signal (Lead I) of the ECG can be detected between the third electrode and the second electrode. A second lead signal (Lead II) of the ECG can be detected between the second electrode and the first electrode. A third lead signal (Lead III) of the ECG can be detected between the first electrode and the third electrode.

[0120] Aspects of the present invention also provide a method for generating an electrocardiogram (ECG) from a patient using a handheld wireless telecommunication device housing having three electrodes on an outer surface of the housing. The patient can be instructed to hold a first electrode of the housing against a leg while touching a second electrode with the right hand and a third electrode with the left hand, such that the patient contacts no more than three electrodes on the housing. A first lead signal (Lead I) of the ECG can be detected between the third electrode and the second electrode. A second lead signal (Lead II) of the ECG can be detected between the second electrode and the first electrode. A third lead signal (Lead III) of the ECG can be detected between the first electrode and the third electrode. The lead signals can be transmitted wirelessly (e.g., using ultrasound) from the housing to the telecommunication device.

[0121] Also described herein is a wearable wristband device that can reliably and conveniently transmit information recorded from a user (e.g., ECG information) using ultrasound. Also described is a monitoring station that includes control logic for configuring and operating a mobile computing / telecommunications device as a monitoring station capable of securely and reliably receiving the ultrasound data.

[0122] Generally, devices, systems, and methods are described herein for ultrasonically transmitting digital and / or analog data from (and in some cases, to) a wearable (e.g., wristband) device having one or more sensors, a microprocessor, and a transducer (i.e., a piezoelectric speaker) capable of transmitting ultrasonic frequencies. The digitally transmitted data can be received by a receiving device (e.g., a telecommunications device (e.g., a personal telecommunications device, such as an iPhone, DROID, or other smartphone, an iPad or other personal computer, or a PDA)) having a microphone capable of receiving audio in the ultrasonic frequency range (e.g., greater than 17 kHz, greater than 18 kHz, between about 16 kHz and about 22 kHz, between about 17 kHz and about 30 kHz, between about 18 kHz and 32 kHz, between about 17 kHz and 42 kHz, etc.). As described in more detail below, the transmitted digital information can be encoded and / or encrypted. Additionally, the information can be compressed (data compression) prior to encryption.

[0123] Both one-way (eg, from a wristband to a device) and two-way communication are contemplated, including various methods for simple two-way communication between a wearable device and a monitoring station (eg, a smartphone).

[0124] Also described herein is an ultrasonic digital modem and digital modem protocols and logic for securely transmitting digital signals using ultrasound from a wearable device, such as a wristband, to a telecommunications device configured as a receiver.

[0125] A wristband device is described herein that includes one or more sensors for sensing activity and / or health information related to a wearer, the one or more sensors including a microcontroller configured as an ultrasonic modem. In some variations, the microcontroller includes logic (e.g., hardware, software, firmware, or some combination thereof) that permits the device to drive ultrasonic transmission of data from a speaker (e.g., a piezoelectric speaker element). Methods of configuring or adapting the microcontroller to operate as an ultrasonic modem are also described. For example, in some variations, the microcontroller can be programmed to operate as an ultrasonic modem. The ultrasonic modem can be configured to format the information to be transmitted into a mixed digital and analog format. In some variations, the ultrasonic modem can be an ultrasonic modem component that encrypts the information using an encryption key.

[0126] This document also describes a receiver configured to receive ultrasonic digital data acoustically transmitted by an ultrasonic digital modem. Typically, a telecommunications device (e.g., a smartphone) can be configured to act as a receiver to receive ultrasonic digital data. Therefore, the telecommunications device may include hardware, software, and / or firmware configured to receive, decode, interpret, display, analyze, store, and / or transmit data transmitted from a digital ultrasonic modem via ultrasonic transmission. In some variations, logic (e.g., client software and / or firmware, applications, etc.) can be executed on the telecommunications device so that the logic can act as a receiver for digital ultrasonic data. Therefore, this document describes executable logic for receiving and interpreting (e.g., decoding) data transmitted by a digital ultrasonic modem, and a device comprising executable logic for receiving and interpreting (e.g., decoding) data transmitted by the digital ultrasonic modem executable logic.

[0127] Further described herein are specific devices and systems configured to include digital ultrasonic modems. Any of these devices may include a digital information source (e.g., a device such as a medical sensor or device (e.g., a thermometer, a pulse oximeter, etc.), an acoustic transducer (e.g., a speaker capable of transmitting an ultrasonic signal), and a controller (e.g., a microcontroller) configured to encode the digital information from the digital information source into an ultrasonic signal to be transmitted by the acoustic transducer. In some variations, the acoustic transducer is configured to transmit audible (e.g., sub-ultrasonic) sounds (e.g., beeps and bleeps within the normal human hearing range) and transmit at ultrasonic frequencies (e.g., greater than 17 kHz).

[0128] In the example described herein, a Texas Instruments AFE4110 digital thermometer was modified as described to encode and ultrasonically transmit temperature data to a telecommunications device (e.g., a smartphone) located at a distance from the thermometer. The device's microcontroller (an MSP430-type controller from Texas Instruments) was configured to include an ultrasonic modem for transmitting ultrasonic digital data by encoding (via a microprocessor) a data signal for transmission over a connected piezoelectric speaker. The speaker can be the same speaker that is pre-installed in the thermometer and used to audibly (e.g., using the normal human hearing range) notify the user that the temperature has stabilized. Thus, a thermometer can be retrofitted to include a digital ultrasonic modem at very low cost by executing control logic in the microcontroller to process data from the thermometer and transmit an encoded signal over the piezoelectric speaker in the ultrasonic frequency range (e.g., >17 kHz). The thermometer can also include a security key (e.g., a barcode, QR code, etc.) printed on the exterior of the device that can be read by a receiving telecommunications device (e.g., a smartphone).

[0129] For example, in some variations, medical sensing devices and systems including such devices are described herein that use ultrasound to digitally transmit bio-parameters received by the medical sensing device to one or more telecommunication devices (e.g., smartphones), where the information can be further processed on the telecommunication devices and / or the information can be transmitted on the telecommunication devices. The executable logic may also be referred to as an adapter for adapting the medical sensing device so that the medical sensing device can transmit bio-parameter information using ultrasound to the telecommunication device for further processing. Systems and / or subsystems for use with the telecommunication device are also described so that the telecommunication device can receive and translate health metric information signals encoded using ultrasound. These subsystems may include client software (e.g., an application) to be run on the telecommunication device (e.g., a phone) to translate the ultrasonic health information (or bio-parameter) signals into digital signals that can be uploaded, stored, and / or analyzed by the telecommunication device.

[0130] A medical sensing device can be any device for receiving biological parameters (such as a patient's vital signs). Biological parameters can also be referred to as biometric data. For example, a medical sensing device can be a thermometer, a blood pressure transducer, a glucose monitor, a pulse oximeter, a pulse rate meter, a pedometer, an activity monitor, a hydration monitor, etc. The medical sensing devices or systems referred to herein are generally digital systems because they can display numerical (e.g., digital) representations of biological parameters. For example, these devices can convert analog biological parameters (e.g., temperature, blood sugar, blood pressure, or any other health metric information) into digital signals that can be displayed or otherwise presented to a user. For example, a medical sensing system can include a digital thermometer for capturing a subject's temperature, a blood cuff for presenting a patient's blood pressure, a blood sugar (glucose) monitor, or a pulse oximeter, etc. (including combinations of these devices). Medical sensing systems or devices for home use are of particular interest, and in particular those that have sensors that monitor or collect biological parameters from a patient and present the information on a display.

[0131] As described in more detail below, in some variations, devices and systems format and / or encode information so that the information includes a mix of digital (e.g., extracted and / or alphanumeric) information and analog (e.g., graphical) information. As used herein, the phrase "analog" refers to information that is sequentially ordered and can be displayed graphically to show changes or trends. Analog information can refer to quantified variable physical levels (e.g., variables that change over time). Actual information can be digital (e.g., by converting from continuous to discrete), but can still be referred to as "analog" herein because it represents changes in one or more parameters over time, distance, or some other change.

[0132] Any information transmitted as an ultrasound signal (e.g., analog, digital, hybrid digital / analog, etc.) can be encrypted. For example, an encryption key can be used to encrypt the information. The encryption key can be displayed on the device transmitting the ultrasound signal or can be utilized by the device in other ways. Typically, the encryption key can be entered into a telecommunications device, so that the specific device is then paired with a device including an ultrasound modem and can receive and decrypt the information. Encryption of the data can allow for the protection of sensitive patient information. Encryption can also reduce noise in the system because it can limit the received signals to those that are properly encrypted.

[0133] As used herein, biological parameters or information may include any patient information processed, sensed, and / or calculated by a medical sensing system, particularly digitally encoded biological parameters. For example, biological parameters may include temperature, blood pressure, blood sugar level, pH, oxygenation, pulse rate, respiratory rate, or any other biological measurement, particularly those parameters relevant to medical conditions, including diagnosis and health monitoring.

[0134] As used herein, a telecommunications device includes a smartphone (e.g., iPhone™, Android™, or other personal communication device), a tablet computer (e.g., iPad or tablet PC, etc.), and / or a desktop computer that includes (or can be adapted to include) a microphone capable of receiving ultrasonic sounds. The telecommunications device may include logic for translating digital signals encoded by ultrasonic sounds into digital signals that can be displayed, uploaded / transmitted, stored, and / or analyzed.

[0135] Thus, in some variations, a medical sensing device for transmitting digital bio-parameters using ultrasound is described herein. In some variations, the device may include: a sensor for detecting a bio-parameter from a patient; a processing device for encoding a digital representation of the bio-parameter into an ultrasonic sound signal; and an ultrasonic transducer for transmitting the ultrasonic sound signal from the processing device.

[0136] For example, the sensor may be a transducer for converting a bioparameter (e.g., a temperature sensor, a pressure sensor, etc.). The device may further include a controller (e.g., a microcontroller) for processing the signal from the sensor(s). The processing device may include a signal generator that generates a signal from the sensed and / or processed patient bioparameter information; 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, one or more information bits (e.g., a packet identifier) that identify the type or source of the bioparameter, a digital representation of the bioparameter, and, in some variations, a cyclic redundancy check (CRC) portion. In some variations, the signal (including the biometric measurement or data portion) may have a time and / or date stamp.

[0137] As described above, 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 (eg, by capturing and / or analyzing a graph describing the encryption key).

[0138] In some variations, the system or device can be configured so that a measurement is taken at time x and stored on the device (e.g., a thermometer, a blood glucose meter, etc.), and is ultrasonically transmitted to a telecommunication device (e.g., a smartphone or tablet) at a slightly later time, and ultimately uploaded (e.g., to the cloud). In some variations, several time / date stamped measurements can be stored on the device and can be transmitted together in a burst to the telecommunication device. As described in more detail below, although in some variations the device can be primarily unidirectional (e.g., sending data from a biometric measurement device to a telecommunication device), the device can be configured to at least receive a confirmation signal and / or an indicator of the proximity of the telecommunication device. In some variations, the ultrasonic transducer can also be configured to receive a confirmation signal from the telecommunication device. The confirmation can indicate that the telecommunication device has received the sent message (data) or that the telecommunication device is ready to receive the sent data, or both.

[0139] The ultrasonic transducer may be any suitable transducer (including a piezoelectric crystal transducer).

[0140] In some variations, a system for transmitting digital bio-parameters using ultrasound includes: a medical sensing device having a sensor for detecting the bio-parameter, a processing device for encoding a digital representation of the bio-parameter into an ultrasound sound signal, and an ultrasound transducer for transmitting the ultrasound sound signal; and client control logic configured to be executed by a telecommunications device and to receive the ultrasound sound signal and convert it back into a digital representation of the bio-parameter.

[0141] The processing device may convert some or all of the digital bio-parameter signals (which are typically numerical values) into ultrasonic signals by using any suitable signal processing technique, including but not limited to frequency shift keying.

[0142] The client control logic may also be referred to as software (although it may be software, hardware, firmware, etc.) or a client application. The client control logic may be executed on the telecommunications device. The client control logic may also include, for example, a component for transmitting the digital representation of the biometric parameter to another device (e.g., uploading it to a website or server). In some variations, the client control logic may be configured to display or otherwise present information locally on the telecommunications device.

[0143] Also described herein is a system for transmitting digital health parameters, the system comprising: an ultrasonic transducer capable of transmitting signals at a frequency greater than approximately 17 kHz (e.g., 19 kHz, or centered around 20 kHz) in an open air environment; and a signal generator configured to generate an ultrasonic signal corresponding to a digital representation of a biological parameter, wherein an identifier is associated with at least one frequency greater than approximately 17 kHz (e.g., 19 kHz, or centered around 20 kHz).

[0144] 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 sensing patient temperature; a signal generator for generating a signal corresponding to a digital representation of the patient's temperature; and an ultrasonic transducer for transmitting the digital representation of the patient's temperature as an ultrasonic signal comprising one or more frequencies greater than 19 kHz. The thermometer may include an encryption key external to the thermometer that can be imaged and / or viewed by a user and / or a telecommunications device configured to receive the ultrasonic signal.

[0145] Generally, a digital ultrasonic modem device for securely transmitting digital data using ultrasound is described herein. Such a device may include: a microprocessor; an ultrasonic transducer; an encryption key located on the device; and ultrasonic transmission logic that configures the digital data for acoustic transmission by the ultrasonic transducer at a frequency of 17 kHz or greater, the ultrasonic transmission logic being further configured to encrypt the digital data according to the encryption key.

[0146] Any suitable ultrasonic transducer may be used. For example, the ultrasonic transducer may be a piezoelectric speaker. As described above, the encryption key may be visually marked on the device and may be configured as an alphanumeric code or symbol, etc. For example, the encryption key may be configured as a barcode, QR code, etc.

[0147] 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 ultrasonic transmission logic that configures digital data for acoustic transmission by the ultrasonic transducer at a frequency of 17 kHz or greater, the ultrasonic transmission logic further configured to encrypt the digital data based on the encryption key; and decryption logic executable on a telecommunications device, wherein the telecommunications device includes a receiver for receiving ultrasonic signals from the ultrasonic communication device, and wherein the decryption logic is configured to receive the encryption key and apply the encryption key to decrypt the ultrasonic signals.

[0148] Typically, the encryption key may be visible on the ultrasonic communication device or the packaging of the device, etc.

[0149] In any of the variations described herein, the telecommunications 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 capturing an image of the encryption key (e.g., a barcode, QR code, etc.) and determining the encryption key based on the image. In some variations, the input includes a manual input (e.g., a keyboard, a touch screen, etc.) for manually inputting the encryption key.

[0150] Also described herein are methods for securely transmitting information using ultrasound. For example, in some variations, the method includes: receiving an encryption key present on an outer surface of an ultrasonic communication device; receiving an encrypted ultrasonic signal from the ultrasonic communication device; and decrypting the ultrasonic signal using the encryption key.

[0151] In some variations, receiving the encryption key includes capturing the encryption key from an external surface of the ultrasonic communication device. Decrypting the ultrasonic signal may include decrypting the ultrasonic signal in the telecommunications device. As described above, receiving the encryption key may include imaging the encryption key using a camera on the telecommunications device.

[0152] In general, any of the systems described herein may use hybrid digital and analog encoding. For example, an apparatus for transmitting 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 comprising digital data appended to the analog data for acoustic transmission by the ultrasonic transducer at a frequency of 17 kHz or greater.

[0153] As mentioned above, information may be encoded using frequency shift keying (FSK); FSK digital data may be appended to analog data that was not FSK encoded but has been frequency modulated to form a hybrid digital / analog signal.

[0154] 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 values, maximum values, variable intervals (e.g., time intervals), ratios, etc.). The analog data may include any suitable signal typically measured from a device sensor, such as an EEG, a subject's temperature over time, a subject's glucose level over time, a subject's blood pressure over time, a subject's oxygen level over time, or a subject's physical activity over time.

[0155] Also described herein are methods for transmitting mixed digital and analog signals using ultrasound. For example, a method may include generating an ultrasound signal comprising digital data encoded using frequency shift keying (FSK) appended to an analog signal comprising a frequency modulated signal modulated at a frequency greater than 17 kHz, and acoustically transmitting the signal using an ultrasonic transducer.

[0156] The method may further include detecting a biological parameter from the patient, wherein the analog signal includes the biological parameter. The method may further include extracting digital data from the analog signal. The analog signal may include an EEG, a temperature of the subject over time, a glucose level of the subject over time, a blood pressure of the subject over time, an oxygen level of the subject over time, or a physical activity of the subject over time.

[0157] In some variations, the method further includes the step of receiving the ultrasonic signal at a telecommunications device having an ultrasonic audio pickup.

[0158] In any of the variations described herein, the ultrasonic signal may be stored prior to transmission. Any of the variations described herein may be encoded with an error correction code. The method may also include retransmitting the ultrasonic signal; the signal may be retransmitted a fixed number of times, or may be retransmitted continuously. In some variations, bidirectional communication may be used between the ultrasonic communication device and a telecommunications device that includes executable logic for receiving and / or decrypting the ultrasonic signal. Thus, in some variations, the telecommunications device may be configured to transmit the signal back to the ultrasonic communication device. The ultrasonic communication device may include a receiver, or it may be adapted to receive the signal on a transmitter (e.g., a piezoelectric element).

[0159] Also described herein is an ECG sensing wristband configured to transmit ECG information to a mobile telecommunication device or devices.

[0160] For example, this document describes a wireless wearable wristband device for receiving electrocardiogram (ECG) signals from a subject wearing the device and transmitting the information to a mobile telecommunication device using ultrasound. The wristband device may include: a wristband body configured to be mounted around a wrist; two or more electrodes for detecting ECG signals from the subject; an ultrasonic transducer; and a processing device coupled to the ultrasonic transducer and configured to receive the ECG signals from the two or more electrodes and encode the ECG signals to be transmitted into ultrasonic signals for transmission by the ultrasonic transducer at a frequency greater than approximately 17 kHz.

[0161] The wristband body can be configured as a band (e.g., any type of watchband), a hoop, a bracelet, etc. In some variations, the wristband includes a "face" area that can be worn facing up on the top of the subject's wrist. The wristband can include a pair of electrodes (or more than two electrodes). For example, in some variations, the wristband includes an inner electrode that faces the wearer's wrist when the wristband is worn, so that the wristband can make reliable contact with the wearer's skin when worn. The second electrode can be located on the face or side of the wristband; the second electrode can be configured to allow the wearer to touch the wristband with the other hand / arm. In some variations, a third electrode can be located on the wristband. For example, the third electrode can be present on the side of the wristband and be configured so that the subject can touch the third electrode to another part of the body (e.g., chest, leg, etc.).

[0162] The processing device can be configured to encode the signal to be transmitted as an ultrasonic signal for transmission by the ultrasonic transducer at a frequency between about 17 kHz and about 30 kHz (or any other range specified herein, including greater than 16 kHz, greater than 17 kHz, greater than 18 kHz, etc.). Generally, the processing device can be configured to encode the signal to be transmitted as a mixed signal including digital information appended to an analog signal.

[0163] The device may also be configured to receive signals (e.g., ultrasonic signals) (including ultrasonic signals from a mobile telecommunications device). In some variations, the device further includes an ultrasonic receiver configured to receive ultrasonic signals from the mobile telecommunications device. This may also enable pairing of information between the devices (e.g., for synchronization, confirmation of transmission of information, etc.). A separate receiving ultrasonic transducer may be used, or the same ultrasonic transducer may be configured to both transmit and receive. For example, the ultrasonic transducer may be configured to transmit signals from the processing device as ultrasonic signals and to receive ultrasonic signals (e.g., from a mobile telecommunications device).

[0164] In some variations, the device (wristband) described herein can be configured to operate with very low power. As described above, the device can include a battery having a voltage of less than 1.8V.

[0165] Typically, the devices described herein can be configured to operate in real time. In particular, ECG information can be received and transmitted in real time; the mobile telecommunications device can display (and / or retransmit) in real time. For example, the processing device can be configured to transmit the encoded ECG signal in real time.

[0166] In general, any wristband device can be configured to have no display or output, or to have only an audible output (e.g., a beep, tone) or an LED (e.g., a simple indicator light). Instead, the device can 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 can include an indicator that indicates when the device is in communication with a mobile telecommunications device. Thus, a wristband device that does not include a display for displaying ECG information can make the device smaller, lighter, and cheaper to manufacture and operate.

[0167] Furthermore, in some variations, these devices may be configured to store a substantial portion of the data (e.g., ECG data) and transmit the data once a receiver, such as a mobile phone, is ready to receive the data. Thus, any of these variations may append additional information, such as a time / date stamp, user input data, etc. Thus, in some variations, the device further comprises a memory coupled to the processing device and configured to store the encoded signal for later transmission.

[0168] In some variations, as described above, the processing device is configured to encode the signal to be transmitted into a digital signal.

[0169] Typically, the apparatus (eg, processing apparatus) may also be configured to determine when the mobile telecommunications apparatus receives a coded signal from the apparatus.

[0170] The wristband device described herein may also be configured as a timepiece and may include a dial and the like.

[0171] This document also describes a wireless wearable wristband device for detecting electrocardiogram (ECG) signals from a subject wearing the device and transmitting the information ultrasonically to a mobile telecommunications device, the wristband device comprising: a wristband body configured to be fitted around a wrist; two or more electrodes for detecting ECG signals from the subject; an ultrasonic transducer; and a processing device coupled to the ultrasonic transducer and configured to receive the ECG signals from the two or more electrodes and encode the signals to be transmitted into a mixed ultrasonic signal for transmission by the ultrasonic transducer at a frequency greater than about 17 kHz, the mixed ultrasonic signal comprising digital information appended to an analog representation of the ECG signal.

[0172] As described herein, the mixed ultrasonic signal can be configured to encode digital information using frequency shift keying (FSK) and append the FSK digital signal to an analog signal that has not been FSK encoded but has been frequency modulated. For example, the processing device can be configured to extract digital information from the ECG signal. In some variations, the digital information includes calibration data for the analog signal. The processing device can be configured to encode the signal to be transmitted into an ultrasonic signal for transmission by an ultrasonic transducer at any appropriate ultrasonic frequency (e.g., a frequency above the normal audible range) such as the frequencies described herein (e.g., at a frequency between about 17 kHz and about 30 kHz).

[0173] In any of these device variations, the device can be configured to send and receive ultrasonic signals. For example, the device can 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) can also be configured to receive ultrasonic signals (e.g., prepare to receive, request to transmit, confirm transmission, request retransmission, etc.). The ultrasonic transducer can be configured to transmit signals from the processing device as ultrasonic signals and receive ultrasonic signals from the mobile telecommunications device.

[0174] This document also describes a wireless wearable wristband device for detecting electrocardiogram (ECG) signals from a subject wearing the device and transmitting the information to a mobile telecommunication device using ultrasound. The wristband device includes: a wristband body configured to be mounted around the wrist; two or more electrodes for detecting ECG signals from the subject; an ultrasonic transducer configured to transmit and receive ultrasonic signals; and a processing device coupled to the ultrasonic transducer and configured to receive the ECG signals from the two or more electrodes and encode the signals to be transmitted into ultrasonic signals for transmission by the ultrasonic transducer at a frequency greater than about 17 kHz. Further, the processing device is configured to receive the ultrasonic signals from the mobile telecommunication device.

[0175] Aspects of the present invention also provide a wireless wearable wristband device to detect electrocardiogram (ECG) signals from a subject wearing the device and transmit the information wirelessly (e.g., using ultrasound) to a mobile telecommunications device. The wristband device may include a wristband body configured to be mounted around a wrist, two or more electrodes for detecting ECG signals from the subject, a wireless (e.g., ultrasound) transducer, and a processing device. The processing device may be coupled to the wireless transducer and may be configured to receive ECG signals from the two or more electrodes and encode the signals to be transmitted into a wireless signal (e.g., an ultrasound signal for transmission by an ultrasound transducer at a frequency greater than about 17 kHz).

[0176] The processing device may be configured to encode the signal to be transmitted as an ultrasonic signal for transmission by the ultrasonic transducer at a frequency between about 17 kHz and about 30 kHz. The processing device may be configured to encode the signal to be transmitted as a mixed signal comprising digital information appended to an analog signal. The device may also include an ultrasonic receiver configured to receive the ultrasonic signal from the mobile telecommunications device. The ultrasonic transducer may be configured to transmit the signal from the processing device as an ultrasonic signal and to receive the ultrasonic signal from the mobile telecommunications device.

[0177] The device may further include a battery having a voltage of less than 1.8. The processing device may be configured to transmit the encoded ECG signal in real time. The device may further 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 the signal to be transmitted into a digital signal. The device may further include an indicator indicating when the device is communicating with a mobile telecommunications device. The processing device may also be configured to determine when the mobile telecommunications device receives the encoded signal from the device. The device may be configured as a clock.

[0178] Aspects of the present invention also provide a wireless wearable wristband device to detect electrocardiogram (ECG) signals from a subject wearing the device and transmit the information wirelessly (e.g., using ultrasound) to a mobile telecommunications device. The wristband device includes a wristband body configured to be mounted around the wrist, two or more electrodes for detecting ECG signals from the subject, a wireless (e.g., ultrasound) transducer, and a processing device. The processing device can be coupled to the wireless (e.g., ultrasound) transducer and configured to receive ECG signals from the two or more electrodes and encode the signals to be transmitted into a hybrid wireless (e.g., ultrasound) signal for transmission, the hybrid wireless signal including digital information appended to an analog representation of the ECG signal. The ultrasound transducer can transmit signals at a frequency greater than about 17kHz.

[0179] The mixed ultrasonic signal can be configured to encode digital information using frequency shift keying (FSK) and append the FSK digital signal to an analog signal that has not been FSK encoded but has been frequency modulated. The processing device can be configured to extract digital information from the ECG signal. The digital information may include calibration data for the analog signal. The processing device can be configured to encode the signal to be transmitted into an ultrasonic signal for transmission by the ultrasonic transducer at a frequency between about 17 kHz and about 30 kHz. The ultrasonic receiver can be configured to receive the ultrasonic signal from a mobile telecommunications device. The ultrasonic transducer can be configured to transmit the signal from the processing device as an ultrasonic signal and receive the ultrasonic signal from the mobile telecommunications device.

[0180] The device may further include a battery having a voltage less than 1.8V. The processing device may be configured to transmit the coded signal in real time. The device may further include a memory coupled to the processing device and configured to store the coded signal for later transmission. The processing device may be configured to encode the signal to be transmitted into a digital signal. The device may further include an indicator indicating when the device is communicating with the mobile telecommunications device. The processing device may also be configured to determine when the mobile telecommunications device receives the coded signal from the device. The device may be configured as a clock.

[0181] Aspects of the present invention also provide a wireless wearable wristband device to detect electrocardiogram (ECG) signals from a subject wearing the device and transmit the information wirelessly (e.g., using ultrasound) to a mobile telecommunications device. The wristband device may include a wristband body configured to be mounted around the wrist, two or more electrodes for detecting ECG signals from the subject, a wireless (e.g., ultrasonic) transducer configured to transmit and receive ultrasonic signals, and a processing device coupled to the wireless (e.g., ultrasonic) transducer and configured to receive ECG signals from the two or more electrodes and encode the signals to be transmitted into wireless (e.g., ultrasonic) signals for transmission via wireless (e.g., ultrasound). The ultrasonic transducer can transmit signals at a frequency greater than about 17 kHz. The processing device can be configured to receive ultrasonic signals from a mobile telecommunications device.

[0182] The wearable computing device may also take the form of a wristband or armband. Aspects of the present invention also provide an external housing or cover for a wrist- or arm-worn computing device. The external housing or cover may include two or more electrodes for detecting ECG signals from a subject and a wireless transmitter for transmitting the ECG signals to the wrist- or arm-worn computing device.

[0183] Figure 1A schematic diagram of a system 1000 for measuring and monitoring one or more biometric or physiological parameters of a user (US) is shown. System 1000 may include a computing device 1100 and an external sensor device 1200 for coupling or removably attaching to computing device 1100. Computing device 1100 may include one or more of the following: a personal computer, a laptop computer, a tablet computer (such as an Apple iPad, an Apple iPod, a Google Nexus tablet, a Samsung Galaxy tablet, a Microsoft Surface, etc.), a personal digital assistant (PDA), a smartphone (such as an Apple iPhone, a Google Nexus phone, a Samsung Galaxy smartphone, etc.), and a wearable computing device (such as Google Glass, a Samsung Galaxy Gear Smart Watch, etc.). In many embodiments, the computing device includes a tablet computer or a smartphone. External sensor device 1200 may be configured to be removably coupled to computing device 1100 and may include a cover for covering the computing device, such as a tablet computer case or smartphone case or cover. In this way, when the user US replaces or upgrades his or her computing device 1100, there may be no need to replace the external sensor device 1200. That is, the same external sensor device 1200 can be used by the user for different computing devices 1100 that the user may have.

[0184] The computing device 1100 may include a processing device 1110, a memory unit 1120 such as a RAM module, a data storage unit 1130 (e.g., a flash memory module, a hard drive, a ROM, etc.), a network interface 1140 configured to connect to a network such as a cellular data network (e.g., using GSM, GSM plus EDGE, CDMA, quad-band, or other cellular protocols) or WiFi (e.g., 802.11 protocol), a local interface 1150, an operating system 1160 (which may be stored on the data storage unit 1130, loaded onto the memory unit 1120, and implemented by the processing device 1110), a first application 1170 (e.g., a first mobile software application ("mobile app") downloaded from an online application distribution platform), a second application 1180 (e.g., 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 may be the Apple App Store, Google Play, the Windows Phone Store, or the BlackBerry App World. 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 touch screen display for navigating 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 a motion detection component, one or more cameras, an additional display, a power supply, a fan, various I / O ports, and the like.

[0185] The external device 1200 may include a sensor 1210, a processing device 1220, and a local interface 1230. The sensor 1210 is configured to couple to the user US via a connection 1215 (e.g., physical contact) to sense or detect one or more physiological parameters of the user US. Typically, the one or more physiological parameters include cardiac parameters of the user, such as heart rate, heart rate variability, blood pressure, blood pressure variability, arrhythmia, seismocardiogram (SCG), SCG parameters, electrocardiogram (ECG), or ECG parameters. Other physiological parameters are also contemplated. For example, the sensor 1210 may include an activity sensor, a blood glucose sensor, a blood oxygen sensor, a thermometer, a respiratory sensor, a metabolic sensor, or an odor detector. The processing device 1220 may receive the detected physiological parameters and process them into signals for the local interface 1230 to send via a connection 1235 to the local interface 1150 of the computing device 1100. The connection 1235 may include a wired connection, such as a USB connection, a FireWire connection, or a Lightning connection. Alternatively or in combination, connection 1235 may include a wireless connection, such as a WiFi connection, a Bluetooth connection, a low-power Bluetooth connection, an NFC (near field communication) connection, or a near-field ultrasonic communication connection as described in U.S. Patent No. 8,301,232 and U.S. Patent No. 8,509,882.

[0186] The first application 1170 can be stored in the storage 1130 of the computing device 1100, loaded onto the memory 1120 of the computing device 1100, and can be executed using the processing device 1110 and the operating system 1160. Under instructions from the first application 1170, the processing device 1110 can couple to the local interface 1150 of the computing device 1100 to receive the detected physiological parameter(s). Furthermore, under instructions from the first application 1170, the processing device 1110 can store the received physiological parameter(s) in one or more of the memory 1120 and the storage 1130 of the computing device. The stored physiological parameter(s) can be time-stamped and tagged with user identification information for later access and analysis. Under instructions from the first application 1170, the processing device 1100 can also cause the physiological parameter(s) to be displayed on the display 1195 of the user interface. For example, the physiological parameter(s) can 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 the physiological data, and may present the interpretation and analysis to the user US. For example, if an arrhythmia is detected, the processing device 1100, under instructions from the first application 1170, may alert the user US or even a remote healthcare provider (such as a doctor, nurse, or hospital) via the network interface 1140. Furthermore, under instructions from the first application 1170, the processing device may be configured to automatically send the physiological data to a remote computing device, a remote server, or a remote healthcare provider (such as a doctor, nurse, or hospital) via the network interface 1140.

[0187] In some embodiments, the processing device 1110, under instructions from the first application 1170 or other applications, can use the measured (one or more) physiological parameters to identify or authenticate the user and perform operations based on the user's identity. For example, the user can be authenticated based on the attributes of the user's heartbeat. The duration of a specific part of the user's heart rhythm, the relative size of the peak of the user's electrocardiogram (ECG), or other relevant amplitudes or amplitude ratios can be processed and compared with a stored profile to authenticate the user. The processing device 1100, under instructions from the first application 1170 or other applications, can be used to generate a baseline profile. In some embodiments, the processing device 1100, under instructions from the first application 1170 or other applications, can use the measured (one or more) physiological parameters to determine the user's mood and provide relevant data.

[0188] For example, the electrical activity of the heart of the user US can be detected and analyzed. A typical heartbeat may include several changes in electrical potential, which can be classified into waves and wave complexes (including P waves, QRS complexes, T waves, and sometimes U waves, as known in the art). The shape and duration of the P wave can be related to the size of the user's atria (e.g., indicating atrial enlargement) and can be the first source of user-specific heartbeat characteristics.

[0189] The QRS complex may correspond to the depolarization of the ventricles and may be divided into three distinct waves: the Q wave, the R wave, and the S wave. Since the ventricles contain more muscle mass than the atria, the QRS complex is larger than the P wave. Additionally, the heart's His / Purkinje system, which may increase conduction velocity to coordinate the depolarization of the ventricles, may cause the QRS complex to appear "spiked" rather than rounded. The duration of a QRS complex in a healthy heart may be in the range of 60 to 100 ms, but may vary due to conduction abnormalities. The duration of the QRS complex may be used as another source of user-specific heartbeat characteristics.

[0190] The duration, amplitude, and morphology of each of the Q wave, R wave, and S wave can vary between individuals and can vary significantly, particularly for users with heart disease or abnormal heart rhythms. For example, a Q wave greater than 1 / 3 the height of an R wave or a duration greater than 40 ms can indicate a myocardial infarction and provide a unique characteristic of a user's heart. Similarly, other healthy ratios of Q and R waves can be used to distinguish between different users' heartbeats.

[0191] The electrical activity of the heart of the user US may also include one or more characteristic durations or intervals that can be used to distinguish different users. For example, the electrical activity of the heart may include a PR interval and an ST segment as known in the art. The PR interval can be measured from the start of the P wave to the start of the QRS complex. The PR interval can typically last from 120 to 200 ms. PR intervals of varying durations may indicate one or more defects in the heart, such as first-degree heart block (e.g., a PR interval lasting more than 200 ms), preexcitation syndrome via an accessory pathway that causes premature ventricular activation (e.g., a PR interval lasting less than 120 ms), or another type of heart block (e.g., a variable PR interval). The ST segment can be measured from the QRS complex to the T wave (e.g., starting at the junction between the QRS complex and the ST segment and ending at the start of the T wave). The ST segment can typically last from 80 to 120 ms and typically has a slightly upward concavity. A combination of the length of the ST segment and the concavity or height of the ST segment can also be used to generate characteristic information unique to each user's heartbeat.

[0192] The T wave can represent the repolarization or recovery of the ventricles. The interval from the beginning of the QRS complex to the apex 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 fragile 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.

[0193] The QT interval, which can represent the total time required for ventricular depolarization and repolarization, can be measured from the beginning of the QRS complex to the end of the T wave. The QT interval can typically last between 300ms and 450ms and can vary based on the user's heart rate. Several correction factors have been developed to correct the QT interval for the heart rate 222. Both the measured QT interval value and the corrected QT interval value can be used to define the unique characteristics of the user's heartbeat.

[0194] Because the heartbeat or heart rate of a user US can vary slightly based on the user's US activity or mood, each authorized user US can first provide the device with a baseline or standard heart rate, heartbeat, or electrical activity before first use. A first application 1170 can be run by the processing device 1110 to record this baseline reading. For example, an external device or sensor 1200 can sample several heartbeats or electrical activity at several different times to detect changes in the user US's cardiac electrical activity. This data can be sent to the computing device 1100. Under instructions from the first application 1170, the processing device 1110 can then process the detected signals to determine several unique characteristics of the user US's cardiac activity and identify appropriate ranges of characteristic values for each processed characteristic. Based on the characteristic values and associated ranges, the processing device 1110 can select one, all, or a subset of these characteristics to define a unique cardiac activity profile for the authorized user US. The specific combination of characteristics and associated ranges can be selected to minimize overlap with other authorized users or based on characteristic values and ranges that do not fall within the range of averages and ranges (e.g., characteristic values and ranges that a typical user who does not use the device would have).

[0195] The system 1000 can be used to authenticate the user US based on the measured electrical activity of the heart of the user US compared to the generated profile. If the measured electrical activity matches the generated profile, the processing device 1110 can authenticate the user US under instructions from the operating system 1160, the first application 1170 or other applications. The processing device 1110 can also be instructed to perform any suitable operation in response to identifying and authenticating the user US. In some embodiments, the processing device 1110 can be instructed to provide access to restricted applications (for example, applications that only a specific user has a license for or that only a specific user has purchased). In some embodiments, the processing device 1110 can be instructed to provide access to specific data or application settings associated with the authorized user US. For example, the processing device 1110 can be instructed to provide a contact list of the identified user US.

[0196] or access to the email account or phone history of the identified user US.

[0197] In one example, the processing device 1110 may be instructed to allow the user US to use the electronic device to access a private banking application or conduct financial transactions (e.g., transfer funds to a different account or purchase merchandise). In some embodiments, the computing device 1100 may load the user US settings and profile to provide a customized display to the user. For example, the computing device 1100 may display icons or options in a manner set by the user, or provide a display using a color scheme, font, or other customizable display attributes associated with the identified user.

[0198] In some embodiments, the system 1000 can use the detected heart rate or heartbeat characteristics to determine the emotion of the user US. In particular, since the permissible determined characteristics associated with each user US can include a range of values, the processing device 1110 can be instructed to determine the distribution of the detected characteristics within the permissible characteristic range. Using the determined distribution, the processing device 1110 can establish the user's emotion and provide electronic device operations or data (e.g., media) associated with the extrapolated emotion.

[0199] In some embodiments, the computing device 1100 may provide media playback based on the user US's detected emotions or heart signal. For example, the computing device 1100 may identify media with beats per minute or other characteristics that are associated or correlated with the user US's heart signal or heart rate and play back the identified media. As another example, the provided media may have a beats per minute that is faster or slower than the user's current heart rate to encourage the user to exercise harder (e.g., during a workout) or to cool down or calm the user (e.g., at the end of a workout).

[0200] Aspects of the present invention may also include processing for performing computing device operations based on a cardiac signal of a user US. In a first step, system 1000 may detect a cardiac signal of the user US. For example, sensor 1210 of external device 1200 may be used to detect the heart rate or heartbeat of the user US. External device 1200 may transmit the detected signal to computing device 1100 via connection 1235. Computing device 1100 may process the received signal using any suitable method (including determining unique characteristics of the signal). Such characteristics may include, for example, the duration between peaks in the EKG signal, the peak value or distribution between peaks in the EKG signal, or any other suitable characteristics as described herein. In a further step, computing device 1100 may determine whether the previously detected user US is an authorized user. For example, computing device 1100 may compare the determined characteristics of the detected cardiac signal with a library of signals associated with known authorized users. If computing device 1100 determines that user US is unauthorized (e.g., the characteristics of the detected cardiac signal do not match the characteristics of cardiac signals stored in memory), computing device 1100 may, in a further step, prevent access to restricted electronic device operations. For example, computing device 1100 may prevent user US from accessing personal or private information associated with other users. As another example, computing device 1100 may prevent user US from accessing applications or operations associated with a specific user (e.g., applications purchased by a specific user). As yet another example, computing device 1100 may prevent user US from accessing any electronic device operations (e.g., no operations except emergency calls).

[0201] If the computing device instead determines that the user US is authorized, the process may proceed to a fourth step in which the computing device 1100 determines the restricted operations associated with the user US. For example, the computing device 1100 may determine specific 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 specific operations or applications associated with the authorized user US (e.g., applications purchased by the user US using an app store, or a system that controls operations associated with a management account). In the fifth step, the computing device 1100 may provide access to the determined restricted operations of the user US. For example, the computing device 1100 may load the determined data. As another example, the computing device 1100 may provide a link for launching a determined personal or private application.

[0202] When the second application 1180 is in the foreground of the display 1195 and is being actively manipulated by the user US, the first application 1170 may also be running in the background of the operating system 1160 to perform one or more of 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 in which the user US operates as the first application 1170 and the external sensor device 1200 measures the user's physiological parameter(s) in the background.

[0203] For example, the external sensor device 1200 may include many form factors, depending on the form of the computing device 1100 and the convenience to the user US.

[0204] Figures 2A to 2K A biometric or physiological parameter measurement and monitoring system 2000 is shown including a smartphone 2100 and a protective smartphone case 2200 . Figure 2A A perspective view of the system 2000 is shown with the smartphone 2100 and the protective smartphone case 2200 separated. The protective case 2200 has a cavity 2200C for receiving the smartphone 2100. Figure 2B and Figure 2C A rear view of system 2000 is shown. Figure 2D A perspective view of system 2000 is shown in which a smartphone 2100 and a protective smartphone case 2200 are coupled or removably attached to each other. 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, or a Blackberry smartphone.

[0205] The smartphone 2100 may include a front face 2110, an edge 2120, a back face 2130, and a display 2140 on the front face 2110. The protective smartphone case 2200 may include a plurality of electrodes for detecting physiological parameters such as an electrocardiogram (ECG). The plurality of electrodes may include a first electrode 2210 and a second electrode 2220. When the smartphone 2100 and the protective case 2200 are coupled together, at least some of the plurality of electrodes will be disposed on the edge 2120 of the smartphone 2100. In this manner, the thinness and low profile of the smartphone 2100 may be maintained, for example, for the convenience of the user. Figure 2B As shown, the first electrode 2210 and the second electrode 2220 may be arranged on the top edge and the bottom edge (ie, the shorter edge) of the protective housing 2200, respectively, opposite to each other. Figure 2CAs shown, the first electrode 2210 and the second electrode 2220 may be respectively arranged on the left and right edges (ie, the longer edges) of the protective housing 2200 opposite to each other. Figure 2B and 2C The back side 2200B of the protective housing 2200 is shown. The electrodes will typically be electrically isolated from each other to avoid short circuits or interference. The electrodes will also typically protrude minimally from the body of the protective housing 2200. For example, the electrodes may be polished, roughened, or otherwise finished to match the outer surface of the protective housing 2200.

[0206] The sensor electrodes described herein can be made of any suitable material. For example, the electrodes can be made of a particular material selected for its specific conductive properties that allow for more efficient transmission of electrical signals reflecting the user's cardiac activity. The electrodes can be made of a silver-based compound, which can provide superior conductivity relative to other metal compounds (e.g., steel or aluminum). The size and position of the electrodes can also be selected to ensure sufficient contact between the user (e.g., the user's hand or finger) and the electrodes. For example, each electrode can include a pad or extended area placed on the outer surface of the body of the external sensor device 1200.

[0207] In use, such as Figure 2E and Figure 2F As shown, the user can hold the system 2000 with their hands so that the first electrode 2210 is in contact with the user's right arm RA and the second electrode 2220 is in contact with the user's left arm LA to measure one or more physiological parameters such as heart rate or ECG. Figure 2E As shown, the first application 1170 may be active on the system 2000 and is displaying the measured parameters in real time. Figure 2F As shown, a second application 1180 (e.g., an email application) can be active on the system 2000 and can be manipulated by the user US while the first application 1170 receives physiological parameter data in the background. By bringing multiple electrodes into contact with the right arm RA and the left arm LA, a lead I ECG can be measured. The user US can also bring the first electrode 2210 into contact with the right arm RA and the left leg LL to measure a lead II ECG. The user US can also bring the first electrode 2210 into contact with the right arm RA and the left leg LL to measure a lead III ECG.

[0208] Other placements of multiple electrodes are also contemplated. Figure 2G As shown, the first electrode 2210 and the second electrode 2220 may be arranged on the corners of the protective housing 2200. In addition, the plurality of electrodes may include a third electrode 2230. Figure 2HAs shown, the first electrode 2210 and the second electrode 2220 may be arranged on the top and bottom edges (i.e., the shorter edges) of the protective housing 2200, while the third electrode 2230 may be present on the side or longer edges of the protective housing 2200. Figure 2I As shown, the first electrode 2210 and the second electrode 2220 may be arranged on opposite corners of the protective housing 2200, while the third electrode 2230 may be present on the side or longer edge of the protective housing 2200. Figure 2J As shown, the first electrode 2210 and the second electrode 2220 may be arranged on the left and right edges (i.e., the longer edges), and the third electrode 2230 may be present on the side or longer edge of the protective housing 2200. In some embodiments, the first electrode 2210 and the second electrode 2220 may be arranged on the edges of the protective housing 2200, and the third electrode 2230 may be arranged on the back surface 2200B of the protective housing 2200.

[0209] In use, such as Figure 2K As shown, the user can hold the system 2000 with their hands to contact the first electrode 2210 with the user's right arm RA, the second electrode 2220 with the user's left arm, and the third electrode 2230 with the user's left leg LL to measure one or more physiological parameters such as heart rate or ECG. Figure 2K As shown, a second application 1180 (e.g., an email application) can be active on the system 2000 and can be manipulated by the user US while the first application 1170 is receiving physiological parameter data in the background. By bringing multiple electrodes into contact with the right arm RA, the left arm LA, and the 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 even be measured simultaneously. A wireless ECG device with three electrodes is further described in commonly owned U.S. Provisional Patent Application No. 61 / 845,254, entitled “Three-Electrode Wireless ECG Apparatus,” filed on July 11, 2013 (the contents of which are incorporated herein by reference).

[0210] Figures 3A to 3FA biometric or physiological parameter measurement and monitoring system 3000 is shown that includes a tablet computer 3100 and a protective tablet computer housing 3200. System 3000 can be similar in many respects to system 2000. However, whereas system 2000 is adapted for use with a smartphone 2100, system 3000 is adapted for use with a tablet computer 3100. Tablet computer 3100 can include an Apple iPad, a Google Nexus tablet, a Samsung Galaxy tablet, or a Microsoft Surface tablet, among others.

[0211] Figure 3A A perspective view of system 3000 is shown in which protective housing 3200 has a cavity 3200C for receiving tablet computer 3100. Tablet computer 3100 has a front face 3110, edges 3120, a back face 3130, and a display 3140. Figure 3B Tablet computer 3100 is shown coupled or removably attached to protective housing 3200 .

[0212] Figure 3B Also shown is a tablet computer protective housing 3200 that may include a plurality of sensor electrodes including a first electrode 3210 and a second electrode 3220. Figure 3B and Figure 3C As shown, the first electrode 3210 and the second electrode 3220 can be arranged opposite each other on the edge 3120 of the tablet computer 3100. Other alternative placements are also contemplated. For example, Figure 3D The first electrode 3210 and the second electrode 3220 are shown disposed on the back surface 3130 of the protective housing 3200. Figure 3E As shown, the plurality of electrodes may further include a third electrode 3230 disposed on the back surface 3130 of the protective housing 3200 .

[0213] System 3000 can be used to measure physiological signals in a similar manner as system 2000 described above. For example, multiple electrodes of system 3000 can be in contact with the user US to measure one or more of Lead I ECG, Lead II ECG, and Lead III ECG. Figure 3F As shown, the user US can operate the system 3000 and the tablet computer 3100 normally, while the first electrode 3210 contacts the user's right arm RA, the second electrode 3220 contacts the user's left arm LA, and the third electrode 3230 (not shown) contacts the user's left leg. Figure 3FA first application 1170 for managing the detected (one or more) physiological parameters is shown to be active on the tablet computer 3100, but it is also conceivable that during the sensing and detection of (one or more) physiological parameters by the first application 1170 and the protective housing 3200, a second application 1180 is instead active and manipulated by the user US.

[0214] Other computing device accessories for simultaneously measuring various physiological parameter(s) of a user US during normal use of the computing device are also contemplated.

[0215] Figures 4A to 4C A biometric or physiological parameter measurement and monitoring system 4000 is shown, which includes a keyboard 4100 of a computing device 1100 and a keyboard accessory 4200 that may include a keyboard wrist rest. The keyboard 4100 may be removably coupled to the keyboard accessory 4100 (removably coupled to the keyboard accessory 4200). Figure 4A and Figure 4B For comparison). The keyboard accessory 4200 includes a physiological parameter sensor such as a plurality of electrodes (such as a first electrode 4210 and a second electrode 4220). Figure 4C As shown, during normal operation of the computing device 1100 by the user US through the keyboard 4100, the first electrode 4210 may contact the user's right arm RA and the second electrode 4220 may contact the user's left arm LA to detect the lead I ECG.

[0216] Figures 5A to 5C A biometric or physiological parameter measurement and monitoring system 5000 is shown including a laptop or palmtop computer 5100 and a sensor assembly 5200. The computer 5100 may be removably coupled to the sensor assembly 5100 (compare Figure 5A and Figure 5B ). The sensor accessory 5200 includes a physiological parameter sensor such as a plurality of electrodes (such as a first electrode 5210 and a second electrode 5220). Figure 5C As shown, during normal operation of the computer 5100 by the user US, the first electrode 5210 may contact the user's right arm RA, and the second electrode 5220 may contact the user's left arm LA to detect the lead I ECG.

[0217] Additional sensor accessories for coupling with everyday use devices are also contemplated. For example, embodiments of the present invention may provide a sensor accessory for a handlebar of a bicycle, a motorcycle, an exercise machine such as a treadmill or elliptical machine or weight machine, a seat, a chair, a pair of glasses, a piece of clothing, and the like. As another example, the sensor system described herein may be in the form of a watch, a wristband, a wristband, or an accessory for these devices. ECG sensing watches and wristbands are described in commonly owned U.S. Provisional Patent Application No. 61 / 872,555, filed on August 30, 2013, entitled “Ultrasonic Transmission of Signals from an ECG Sensing Wristlet.” The sensor accessory may detect and measure one or more physiological parameters and communicate the measurements to a computing device associated with the everyday use device or to another computing device.

[0218] Figure 6 A method 6000 for biometric or physiological parameter measurement and monitoring is shown. In step 6050, a computing device such as the computing device 1100 described herein may be provided. In step 6100, an external device or housing for the computing device such as the external device 1200 described herein may be provided. In step 6150, the external device or housing may be coupled to the computing device. For example, see system 2000 ( Figures 2A to 2D ), the system 3000 described herein ( Figures 3A to 3B ), the system 4000 described herein ( Figures 4A to 4C ) and the system 5000 described herein ( Figures 5A to 5C ). In step 6200, a physiological signal or parameter measurement and monitoring application may be downloaded to the computing device. The application may include the first application 1170 described above and 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 be brought into contact with a user to measure (one or more) physiological parameters. In step 6350, (one or more) physiological signals or (one or more) parameters may be measured. In step 6400, (one or more) physiological signals or (one or more) parameters may be stored, displayed, or otherwise processed. In step 6450, the physiological signal or parameter measurement and monitoring application may be placed in the background of the computing device. In step 6500, a second application may be run on the computing device while the physiological signal or parameter measurement and monitoring application is performing its operations in the background.

[0219] While the above steps illustrate a method 6000 for measuring and monitoring a biometric or physiological parameter, those skilled in the art will recognize numerous variations based on the teachings described herein. These steps may be performed in a different order. Steps may be added or omitted. Some of these steps may include substeps. As many of these steps as are beneficial may be repeated.

[0220] One or more of the steps of method 6000 can be performed using circuitry as described herein (e.g., one or more processing devices or logic circuits of a computing device or its accessories). The processing device or logic circuit can be programmed to provide one or more of the steps of method 6000, and the program can include program instructions stored on a computer-readable memory or programmed steps of the logic circuit.

[0221] Generally, described herein are apparatus and methods for generating an electrocardiogram (ECG) from a patient comprising a handheld wireless telecommunication device housing having three electrodes on an outer surface of the housing, and methods of using the same. These apparatus and methods can permit a user to acquire up to six leads (e.g., Lead I, Lead II, Lead III, aVR, aVL, and aVF) using a single handheld device that is easily held by the patient against his or her legs while observing the device's display. In particular, the apparatus can be used in conjunction with a mobile telecommunication device (e.g., a smartphone). In another embodiment, the apparatus is capable of operating as a standalone device, having appropriate circuitry to function independently or communicate with a separate telecommunication device.

[0222] Typically, the apparatus described herein (including devices and systems) may include three electrodes and be configured for use with a wireless telecommunication device. The wireless telecommunication device may be any suitable telecommunication device including a smartphone (e.g., iPhone™, Android™, etc.), a tablet computer (iPad™, etc.), a laptop computer, a PDA, etc. The apparatus may be configured as a housing and / or accessory for a mobile telecommunication device. The apparatus may communicate information wirelessly to the mobile telecommunication device. In some variations, the system described herein sends information to a mobile telecommunication device that has been configured to receive and analyze information from the apparatus (e.g., via an operating program or application ("app"), etc.).

[0223] Thus, generally, the devices described herein may include a housing configured as a case or the like. The housing typically includes an outer surface having three (or in some cases, more) electrodes arranged thereon. In variations where the housing is configured as a housing for holding a mobile telecommunications device, the housing may have an outer rear surface and at least two outer side surfaces perpendicular to the rear surface, and a front area through which a screen of the telecommunications device held in the housing can be viewed.

[0224] For example, 9A to 9D One variation of a housing configured as a housing for a smartphone is illustrated. In this example, a housing 300 is shown having a mobile telecommunications device (smartphone) 301 housed within the housing. The housing 300 includes ( Figure 9C shown) back and ( Figure 9B and Figure 9D The front of the housing 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 housing may also include openings on the sides for phone controls (e.g., Figure 9B ).

[0225] Typically, the housing also includes at least (and in some variations, exactly) three electrodes, each for contacting the right hand, left hand, and leg of the subject. For example, the first electrode can be configured to remain against the patient's leg. The second and third electrodes can also be configured and arranged on the housing so that the patient can touch the second electrode with his right hand and the third electrode with his left hand while holding the first electrode against their leg. The position, shape, and / or size of the electrodes can be configured so that when measuring ECG, the patient's hand does not contact more than one electrode on the housing, and the patient's leg does not contact more than one electrode on the housing. For example, the first electrode can be located on the side or side edge (rear edge) of the housing, or both, while the second and third electrodes are located on the back, and all electrodes are separated far enough from each other to avoid contact between the leg or hand and more than one electrode. Therefore, the left hand can contact a single electrode, the right hand can contact another electrode, and the leg can contact the first (leg) electrode all on the same housing.

[0226] exist Figure 9A In the embodiment of the present invention, the electrodes are arranged so that the first electrode 309 is on one of the outside surfaces of the housing. Placing the first electrode on the side of the housing can allow the first electrode to be easily held against the subject's leg while the patient holds the housing so that their first (e.g., left) hand contacts the second electrode and their other (e.g., right) hand contacts the second electrode.

[0227] In general, in any of the devices described herein, the electrodes can be on an outer surface of the housing; in some variations, the housing can be configured (or can include additional features) to protect one or more electrodes from contacting a surface, such as a work surface, when the device is placed on the work surface. In the case where the device is placed on a conductive surface (e.g., a metal work surface), the housing or additional features can prevent the outer surfaces of the electrodes from contacting the surface. For example, the electrodes on the outer surface of the housing can be recessed relative to at least a portion of the outer rear surface, such that when the housing is placed on the work surface with the outer rear surface facing the work surface, the outer contact surfaces of the first electrode, the second electrode, and / or the third electrode do not contact the work surface.

[0228] As described above, placing the first electrode on the side surface may allow the device to be used to take measurements from the leg while viewing the surface (eg the screen) of the telecommunication device within the housing.

[0229] exist 9A to 9D In FIG, the housing includes only three electrodes 309, 311, and 313, and the first (leg) electrode is located on the side outer surface of the housing. The side (first) electrode is configured to extend along most of the length of the side of the housing. The second electrode 311 and the third electrode 313 are positioned closer to the center of the rear outer surface of the housing. As in FIG Figure 9B and Figure 9D As is apparent from the side profile view of FIG, the housing protects the second and third electrodes because the height of the electrodes is lower than the outer surface of the rest of the housing.

[0230] 10A to 10D Another variation of a housing with three electrodes is illustrated. However, in this example, the first (leg) electrode 413 does not have an outer surface that is lower than the outer surface of the housing, but rather Figure 10D As shown, the third electrode protrudes from the outer surface. The housing shown is otherwise similar to 9A to 9D Although these figures are shown without a mobile telecommunications device (e.g., a smartphone) within the housing.

[0231] In some variations, such as Figures 11A to 11C As shown, the leg electrode (electrode 1) 509 extends from the side surface to the back surface where the other electrodes 511, 513 are located.

[0232] Alternatively, in some variations, such as Figure 12C As shown, the leg electrodes are located near an edge of the housing (e.g., near a side edge). Typically, the leg electrodes can be adjacent to one of the side surfaces. The electrodes can be adjacent to the side and can contact the edge. 12A to 12CThe housing is illustrated as being configured so that the first electrode 613 is adjacent to a side of the housing; the second electrode 609 and the third electrode 611 may be offset away from the first electrode to prevent inadvertent contact of the subject's hand and leg electrodes (or another electrode).

[0233] 13A to 13C Another variation of the housing is illustrated, as shown in the figure, with a first electrode 709 extending from the rear surface and around the side edge to the side surface. In this example, the second and third electrodes are recessed relative to the outer surface of the rear surface of the housing, while the first electrode extends from the outer surface. This can make it easier to access the legs and hold the housing at a certain angle.

[0234] In some variations, the housing can be configured to hold an electrode unit that fits within an opening in the outer rear surface of the housing; the electrode unit includes the second electrode and the third electrode (and in some variations, the first electrode), and may also include circuitry for controlling / receiving ECG recordings. For example, 14A to 14C The device is illustrated as a housing that holds an electrode unit 805 including a second electrode 811 and a third electrode 813 to be touched by the patient's right and left hands, and a separate first electrode 809 on the side of the housing. The electrode unit can extend from the housing and can include an outer (non-electrode) surface that extends further from the outer surface of the housing than the second and third electrodes, thereby preventing the second and third electrodes from touching the surface of the table when the device is placed on the table.

[0235] Figures 15A to 15C Another variation of a three-electrode housing is illustrated, where all three electrodes (first electrode 909, second electrode 911, and third electrode 913) are disposed on the rear surface of the housing as shown.

[0236] While many of the variations described herein have all three electrodes integrated on the outer surface of the housing, in some variations, one or more of these electrodes may be configured to extend from the surface of the housing. Figure 16A and Figure 16B , an example of a device having a first electrode 1009 that can extend from the housing on a lead is shown. When not in use, the lead can be retracted into the housing and the electrode 1009 can be coupled to the housing. In use, the electrode can be pulled out of the housing and can contact the patient's leg so that the housing and smartphone can be held and viewed by the patient. In any of these variations, the smartphone can provide visual feedback to the patient before or during recording. For example, indicating that good electrical contact is being made and / or showing the ECG trace captured by the system.

[0237] For example, Figure 17A method of operating an apparatus 400 having two hand (right hand, left hand) electrodes and a leg electrode is illustrated. In this example, a subject SU is sitting in a chair CH and holding a device 400 configured to hold a smartphone housing with both hands, such that each hand contacts only one electrode on the back of the housing. The housing is held against the subject's legs so that the leg electrodes are pressed against the legs. Then, as described above, the housing and smartphone can be used to record Lead I, Lead II, and Lead III, from which at least three additional leads can be determined. Specifically, pressurized leads (aVR, aVL, and aVF) can be determined.

[0238] As described herein, a 12-lead ECG can be generated using three electrodes (e.g., by any of the devices described herein). For example, in one embodiment, a device with three electrodes as described herein can be used to determine Lead I (e.g., the voltage between the left and right arms) simultaneously with Lead II (e.g., the voltage between the left leg and the right arm), and Lead I simultaneously with Lead V2. In other embodiments, any other combination of leads is possible. Processing logic can then time-align the two sets of recordings so that the two sets of measurements can be compared over the same simulated time period.

[0239] The processing logic can further transform the two sets of leads to generate a complete 12-lead ECG. In one embodiment, the processing logic can use a machine learning model (e.g., a neural network, deep learning technology, etc.) to perform this transformation. The machine learning model can be trained using 12-lead ECG data corresponding to a population of individuals. Before being input into the machine learning model, the data can be pre-processed to filter the data in a manner suitable for the application. For example, before being used to train one or more machine learning models, the data can be classified according to height, gender, weight, nationality, etc., so that the one or more models thus obtained are fine-tuned for a specific type of individual. In another embodiment, the machine learning model can be further trained based on the user's own ECG data to further fine-tune the model.

[0240] In one embodiment, using the machine learning techniques described herein, a complete 12-lead ECG can be generated using only three electrodes in a single device. As described herein, the three electrodes can be positioned on the device in any suitable manner, including two on the front of the device and one on the back.

[0241] Generally, the present invention also describes devices and systems for ultrasonically transmitting information (e.g., bio-parameter information) from a wearable (e.g., wristband) sensing device to a telecommunications device using an ultrasonic transmission device, which can then process and / or transmit the bio-parameter information. In particular, the bio-parameters can include ECG signals. The wearable device typically includes an ultrasonic transducer, which can be part of an ultrasonic modem module / subsystem for encoding and transmitting information as an acoustic ultrasonic signal. In many of the variations described herein, the devices are configured as a wristband to be worn by the subject.

[0242] As will be described in detail below, in some variations, an encryption key can be used to securely transmit an ultrasound signal (e.g., an encoded ECG). Also described herein are systems, methods, and apparatus for easily pairing an ultrasound transmission device with a telecommunications device using an encryption key. For example, in some variations, the telecommunications device can read an encryption key displayed on the ultrasound transmission device (e.g., by capturing an image thereof). This technique can be readily performed by using the telecommunications device to capture an image of a marking (e.g., a barcode, QR code, etc.) containing the encryption key and determining the encryption key based on the image. Executable logic (e.g., decryption logic) running on the telecommunications device can be configured to interpret and apply the encryption key.

[0243] For example, a system capable of transmitting digital bio-parameter information using ultrasound may include a sensor for sensing a bio-parameter (e.g., a vital sign), a processing device for configuring a representation of the bio-parameter as a "digital" ultrasonic signal, an analog signal, or a mixed digital / analog signal, and a transducer for converting the ultrasonic signal so that it can be transmitted over the air to a device with telecommunications capabilities. The processing device may be part of a controller (e.g., a microcontroller), controlled by the controller (e.g., a microcontroller), or in communication with the controller (e.g., a microcontroller). The device with telecommunications capabilities (telecommunications device) may include a receiver (audio receiver) capable of receiving audio signals in the ultrasonic range, and a processing device for converting the ultrasonic signal back into an electronic signal for further processing or transmission.

[0244] The human hearing range is often stated to be 20Hz to 20kHz, however, under ideal laboratory conditions, children's maximum hearing range is actually as low as 12Hz, and in rare cases as high as 20kHz. Figure 18 As shown in Figure 1, the threshold frequency (i.e., the minimum intensity that can be detected) rises rapidly to the pain threshold between 10kHz and 20kHz. Therefore, sounds above about 16kHz must be quite intense to be heard. Almost from birth, the threshold sound level for these higher frequencies increases. Figure 19As shown, the average 20-year-old loses about 10dB in the 8kHz range, while at age 90, the average person loses over 100dB in this frequency range.

[0245] An example product using very high frequency sounds is the mosquito alarm, a controversial device that emits an intentionally annoying 17.4kHz alarm and is used to discourage young people from loitering. Due to adult hearing loss at this frequency, it is typically only heard by people less than 25 years old. Similarly, students take advantage of adult hearing loss by using a 15-17kHz "mosquito" ringtone on their phones during school. The students can hear the mosquito ringtone, but their adult teachers cannot. The term "ultrasonic" generally refers to a range above human perception. However, as shown in the figure, the upper limit of hearing frequency varies with individuality and age. Due to the difference in this upper limit, the term "ultrasonic" defined herein and in the appended claims can refer to a sound frequency of 16kHz or greater (e.g., greater than about 17kHz, greater than 18kHz, etc.).

[0246] Interestingly, however, there is almost no ambient sound or noise above about 10kHz. Figure 20 , most everyday sounds occur at frequencies below about 4kHz. Therefore, the use of signals in the ultrasonic range is not only silent to the surroundings, but also provides a very desirable signal-to-noise ratio (SNR).

[0247] Acoustic engineers safely assumed that any frequency above about 20kHz would have no effect on perceived sound, and that everything above that range could be filtered out. Sounds below 20kHz, but still within the ultrasonic range, were of little concern, and standard sampling procedures were established accordingly. It is generally understood that sampling an analog signal (whether a radio signal or an audible sound signal) requires a sampling frequency fs such that fs / 2>f, where f is the sinusoidal frequency. For this reason, sound systems were designed to sample sound at the now-standard sampling rate of 44.1kHz, which is set slightly above the Nyquist-Shannon sampling rate of 40kHz calculated for the 20kHz sound upper limit. Using existing demodulation procedures, computers, telephones, cell phones, stereo systems, etc., actually demodulating FM narrowband signals in the ultrasonic range would result in a very poor reproduction of the original signal. This is unfortunate because, as mentioned above, carrier signals in the ultrasonic range will also have a very low signal-to-noise ratio due to the fact that there is very little natural "noise" at these higher frequencies.

[0248] Apparatus, methods, and systems for measuring physiological signals (e.g., bioparameters) and wirelessly and silently transmitting digital information related to these measurements use ultrasonic signals having a greatly improved signal-to-noise ratio compared to conventional telephone transmission methods. Methods and algorithms for receiving and demodulating ultrasonic signals with excellent accuracy using existing computer and smartphone technology are also provided.

[0249] Figure 21A A schematic overview of a system including a data input 0433 (e.g., providing any type of information, including digital and / or analog information) and a microcontroller 0405 is shown. In some variations, the microcontroller includes or is coupled to a processing device for encoding a digital representation of a biological parameter, and as described in more detail below, this encoded signal can be converted into an ultrasonic signal. For example, the encoded signal can be ultrasonically transmitted by an ultrasonic transducer 0407. In some variations, the microprocessor and transducer can be coupled together or formed as part of the same component 0405'; alternatively, the microprocessor can include a piezoelectric / speaker element. This ultrasonic signal 0420 can then be received by a telecommunications device 0425 including an audio pickup (receiver) 0429. The telecommunications device 0425 can run client control logic 0427, which prepares the telecommunications device to receive and interpret the ultrasonic signal so that it can be processed, for example, by converting the ultrasonic signal back into an electronic signal and interpreting what type of signal it is (e.g., pulse rate, temperature, etc.).

[0250] Figure 21B A schematic diagram of a system is shown that includes a medical sensing device 0401 (e.g., a thermometer or blood glucose monitor) having a microcontroller 0405 and a sensor 0403 for detecting a biological parameter (e.g., body temperature, pulse rate, blood glucose, etc.) from a patient. The microcontroller may include or be coupled to a processing device for encoding a digital representation of the biological parameter, and as described in more detail below, the encoded signal may be converted into an ultrasound signal. For example, the encoded signal may be transmitted ultrasonically by an ultrasound transducer 0407. The ultrasound signal 0420 may then be received by a telecommunications device 0425 that includes an audio pickup (receiver) 0429. The telecommunications device 0425 may execute client control logic 0427 that prepares the telecommunications device to receive and interpret the ultrasound signal so that it can be processed, for example, by converting the ultrasound signal back into an electronic signal and interpreting what type of signal it is (e.g., pulse rate, temperature, etc.).

[0251] Thus, the medical sensing device 0401 in this example includes a sensor (or sensor assembly) configured to sense one or more physiological signals such as temperature, pulse, or pressure (e.g., blood pressure). The sensor can generate electrical signals representing the sensed physiological signals, and these signals can be converted into one or more digital signals that are input to a microcontroller or other associated components. The digital signal can typically be displayed on the device (not shown) and can also be electrically encoded as part of a digital signal, which can then be ultrasonically encoded into ultrasonic sound (e.g., by techniques such as frequency shift keying) and transmitted from the device. The encoding of the signal can be performed by any suitable circuit (e.g., including a microcontroller such as an MSP430 (e.g., an AFE4110 from Texas Instruments)).

[0252] The center frequency may be selected from any suitable ultrasonic frequency (including but not limited to 20 kHz). In some variations, the medical sensing devices described herein are configured to transmit only, such that data is transmitted to (but not received from) the telecommunications device. In some variations, the medical sensing devices are configured to send and receive ultrasonic (sound) frequency information (e.g., see Figure 21C and Figure 27 ). In addition, in some variations, multiple channels (frequency channels) can be used.

[0253] exist Figure 21C , a schematic diagram of a medical sensing device (e.g., a wristband configured as an "ECG watch" to detect ECG signals and transmit the ECG signals to a telecommunications device) is shown. In this example, the device (e.g., wristband) includes a sensor 0403. In some variations, the sensor may include two or more electrodes to detect ECG signals. The 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. The telecommunications device 0425 may be configured to receive (via an audio pickup 0429) and transmit (via an ultrasonic transmitter 0433) ultrasound (such as ultrasound sent by the medical sensing device 0401).

[0254] In one embodiment, the center frequency of the ultrasonic signal is in the range of about 17 kHz to about 32 kHz. In another embodiment, the center frequency of the frequency modulated ultrasonic signal is in the range of about 18 kHz to about 24 kHz, or about 20 kHz to about 24 kHz.

[0255] Figure 22A variation of a digital signal that has been encoded using key shifting is shown. In this variation, the ultrasound signal is modulated with two different frequencies, one representing a high ("1") and one representing a low ("0"). For example, the frequencies of 0 and 1 can be selected to be centered around 20 kHz (e.g., 19.5 kHz and 20.5 kHz).

[0256] In some variations, as described above, the sensor encodes an ECG signal, however, in general the sensor may include any suitable sensor operable to detect a physiological signal that the user desires to monitor. Multiple sensors may be included. Non-limiting examples of such physiological signals include, but are not limited to, respiration, heartbeat, heart rate, pulse oximetry, photoplethysmography (PPG), temperature, and the like. A respiratory detector may be used. Heartbeat and heart rate may also be detected. For example, a pulse oximetry sensor may be used to indirectly monitor the oxygenation of a person's hemoglobin in a non-invasive manner, rather than measuring directly from a blood sample. The sensor is placed on a thin part of the human body (such as a fingertip or earlobe), and light containing red and infrared wavelengths is passed from one side to the other. The change in absorbance of each of the two wavelengths is measured, and the difference is used to estimate the oxygen saturation of the person's blood and the change in blood volume in the skin. A photoplethysmogram (PPG) may 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 may then be used and transmitted as described herein. In (reference below) Figure 26A and Figure 26B In some variations of the foregoing, analog information may also be encoded and / or appended to digital information to form a mixture of analog and digital information transmitted by the ultrasonic transmission device.

[0257] In some variations, the transducer assembly converts an electrical (eg, digital, analog, etc.) encoding of a biological parameter into an ultrasound signal that can be transmitted. Figure 21A In the illustrated embodiment, the converter assembly 0405' includes an ultrasonic transducer 0407 for outputting an ultrasonic signal. Non-limiting examples of suitable ultrasonic transmitters (including transducers) include, but are not limited to, micro speakers and piezoelectric buzzers, among others.

[0258] Within the telecommunication device 0425 , the ultrasonic signal may be received by, for example, a microphone 0429 in a device such as a smartphone, a personal digital assistant (PDA), a tablet personal computer, a pocket personal computer, a notebook computer, a desktop computer, and a server computer.

[0259] The volume of the signal can be kept low to conserve power, although higher volumes are possible because the sound is inaudible. For example, the volume of the signal can be increased further at ultrasonic frequencies without worrying about the presence of an "auditor" because the audience cannot hear the signal. In addition, the signal can be encoded to prevent other devices (not paired with the ultrasonic transmitting device) from receiving and understanding the signal.

[0260] As described above, the telecommunications device may include a processing device configured by client logic (e.g., software) for receiving and processing ultrasound signals. For example, software on a smartphone may decode the ultrasound signal. Processing of the data may provide additional information related to the user (including the type of information (e.g., the nature of a biological parameter)). For example, the signal may be encoded such that the signal (after a start identifier) contains: 8 pulses representing ECG data; 10 pulses representing that the signal is a thermometer reading (e.g., with the last 4 digits after the decimal point); 12 pulses representing that the signal is a blood pressure reading (e.g., 3 digits for systolic pressure, 3 digits for diastolic pressure, and 3 digits for pulse rate); 14 pulses representing that the signal is pulse oximeter data (e.g., 3 digits for 02sat and 3 digits for pulse rate); 16 pulses representing that the signal is blood glucose meter data (e.g., 3 digits for blood glucose level); and so on. A "delimiter" may exist between the digits and the EOM (end of message) indicator. In practice, the signal may be sent several times so that comparisons can be made between the received data for verification.

[0261] In one variation, the signal can be encoded such that (assuming 8-bit bytes plus start and stop bits): a certain number of AAs or 55s to allow synchronization; a byte representing a version number; a one-byte length for the remainder of the packet; a one-byte packet identifier (0x01 for BP, 0x02 for pulse ox, 0x03 for glucose, etc.); the data; and an 8-bit CRC.

[0262] In some variations, a signal may also include a segment of analog data (e.g., a signal over time, a signal over distance, etc.) for transmission along with the digital information, including information for formatting the analog data or extracting (e.g., scaling) the analog data. For example, a signal for transmission via ultrasound 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), duration, average value, etc. Analog, digital, and analog and digital (mixed) signals may be encoded (including encrypted encoding) and / or may include error correction codes.

[0263] As described above, the signal may have a time and / or date stamp. In some variations, the device or system may be configured to take multiple measurements and send them in batches or bursts to the telecommunications device. For example, measurements may be taken at times ti, t2, etc., and the measurement results stored on the device (e.g., a thermometer, a blood glucose meter, etc.), and transmitted to the telecommunications device (e.g., a smartphone, a tablet, etc.) using ultrasound at a later time (tn). The data may be processed by the telecommunications device and / or uploaded to an external server, etc. (e.g., a cloud).

[0264] The baud rate of the transmitted ultrasonic data can be selected to allow for fast transmission. For example, if a baud rate of about 300 baud is used, transmission may take less than one second even for batch signals. In some variations, the baud rate is about 400.

[0265] As described above, the raw signals from the sensors and the derived information can be displayed and stored locally on the smartphone, as well as transmitted to a web server via an Internet connection. The software on the web server can provide a web browser interface for real-time or retrospective display of the signals and information received from the smartphone, and also include further analysis and reporting.

[0266] Ultrasonic signaling as used herein generally refers to the use of ultrasonic signals to transmit information (such as the amplitude of a biological parameter and the origin of the biological parameter measurement results). As described above, these ultrasonic signals can be encoded to allow transmission and processing. The encoded signal can then be converted into the ultrasonic range by any appropriate method. For example, one or more frequencies corresponding to various signal values can be used, such as DTMF or DTMF frequency-shifted to the ultrasonic frequency. Another example of converting the signal is to use amplitude shift keying. Another example is to use frequency shift keying. Another example is to use phase shift keying. In some embodiments, multi-frequency signaling such as spread spectrum communication or multi-frequency carrier signaling can be used. An example of multi-frequency carrier signaling is to specify a predetermined set of frequencies (e.g., between 20 kHz and 22 kHz, or between 20 kHz and 24 kHz, or generally between a lower limit of 19 kHz and 20 kHz and an upper limit of the Nyquist frequency that is equal to or slightly below the sampling rate of the intended receiver) separated by intervals (e.g., intervals between 40 Hz and 100 Hz, or approximately 65 Hz, etc.), and for each such frequency, encode a "1" bit as the presence of a carrier signal (such as a sine wave at that frequency) and a "0" bit as 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 identify whether a carrier is available at each relevant frequency and, from this, infer the set of bits that encode the number. In some embodiments of multi-frequency carrier signaling, for example, when the signal is not sufficiently well-defined, multiple samples can be acquired over time and averaged, and the averaged signal can then be processed as described above. In some embodiments of multi-frequency carrier signaling, for example, when the frequencies are close enough to cause interference, a Viterbi decoder can be used to decode the bit pattern. Generally, techniques known to those skilled in the art of communications, particularly techniques for modulation and demodulation (e.g., modems), may be employed. Examples of such techniques include the various modem standards designated Vx (where x is an integer) promulgated by Sector T of the International Telecommunication Union, the entire contents of which are incorporated herein by reference for all purposes.

[0267] In some embodiments, instead of (or in addition to) the telecommunications device, a server may perform signal analysis to determine the coded data. In some embodiments, the signal may be stored at the server and provided to personnel for refinement of the transmission and / or reception technique.

[0268] As described above, signaling can be performed by a transmitter. The transmitter can include a hardware system including a signal generator, such as a processing device, such as a microprocessor, microcontroller, or digital signal processor connected to a memory (e.g., DRAM or SRAM, which in some embodiments may be integrated with the processing device) containing program instructions executable by the processing device and / or data used by the program. The transmitter can also include persistent storage, such as flash memory, coupled to and / or incorporated into the processing device. The signal generator can generate the ultrasonic signal for transmission as described above. In some embodiments, the waveform used for transmission can be stored in the persistent storage. In some embodiments, the transmitter includes a power supply and / or battery, or uses the power supply used to power other components of the medical sensing device. As described above, the transmitter can include a transducer, such as a piezoelectric transducer, that converts electrical pulses into ultrasonic vibrations. The transmitter can include an amplifier coupled to the processing device (directly or indirectly, such as via an audio digital-to-analog converter (DAC), which in some embodiments may be integrated with the processing device), which provides the electrical pulses to the transducer via its output. In some embodiments, the transmitter may include a real-time clock and / or a receiver for receiving a broadcast time signal. In some embodiments, the transmitter may include an encryptor, which may be, for example, program instructions executed on a processing device, or a separate integrated circuit. In some embodiments, the transmitter may include an error correction code generator and / or an error detection code generator, which may be, for example, software instructions executed on a processing device, or a separate integrated circuit. The techniques described herein for transmitting and receiving acoustic signaling may be performed at a transmitter as described herein in a manner that will be readily understood by those skilled in the art.

[0269] In some variations, the transmission from the medical sensing device to the telecommunication device is unidirectional, generally offering advantages such as design simplicity, lower cost, and lower power consumption. These advantages are particularly useful when compared to systems where the medical sensing device includes an additional receiver (including a microphone or antenna for receiving acoustic signals). However, in some configurations, the medical sensing device may be adapted to receive a simple indicator signal from the telecommunication 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) may be used as a 20 kHz sensor to implement a return acknowledgement (ACK). For example, after receiving, decoding, and verifying the CRC, the telecommunication device (e.g., a phone) may generate a short 20 kHz burst to signal to the sensor that the telecommunication device received it correctly, indicating that retransmission is not necessary. In other variations, the signal from the telecommunication device may indicate that the telecommunication device is ready to receive transmissions from the biometric measurement device. Paired or multiple timing signals / acknowledgements may also be used.

[0270] In one example, the device or system is configured so that the data transmitted using ultrasound includes forward error correction (FEC), thereby allowing the receiver to correct N bit errors. This can be particularly useful if the system is configured so that the biometric measurement device (medical sensing device) is a one-way transmission (e.g., unidirectional). FEC can help ensure that the data is received correctly.

[0271] In some embodiments, the data transmitted by ultrasonic signaling may be processed to include error correction codes such as BCH codes, fixed-weight codes, convolutional codes, group codes, Golay codes such as binary Golay codes, Goppa codes, Hadamard codes, Hagelbarger codes, Hamming codes, Latin square-based codes, dictionary codes, sparse graph codes such as low-density parity-check codes, LT or "fountain" codes, online codes, Raptor codes, Reed-Solomon codes, Reed-Muller codes, repeat-accumulate codes, repetition codes such as triple modular redundancy codes, Tornado codes, Turbo codes, or other error correction codes known to those skilled in the art. In various embodiments, such codes may be applied in a single dimension or multiple dimensions, may be combined, and may be combined with error detection codes such as parity checks and cyclic redundancy checks. The error correction codes, depending on their respective techniques, may be decoded and applied to correct transmission and / or reception errors at the receiver or at a server receiving communications from the receiver.

[0272] Example 1: Digital Thermometer

[0273] In one example, a digital thermometer can be configured to include a digital ultrasonic modem. In this example, a digital thermometer based on a Texas Instrument MSP430 digital thermometer has been adapted to include firmware that enables the firmware to ultrasonically transmit temperature readings (digital data) to a mobile telecommunications device (e.g., an iPhone). Although this example is specific to an APE 4110 microprocessor (a variation of the MSP 430 microprocessor from Texas Instrument), other microprocessors can be used and similarly adapted with firmware, software, and / or hardware to function.

[0274] Typically, the device can capture data (e.g., a thermometer temperature reading) and encode the data for ultrasonic transmission. The encoded signal can include error checking (e.g., CRC encoding, Hamming code, etc.) and can be encrypted. For example, the data can be encrypted using, for example, the Advanced Encryption Standard (AES). U.S. Patent No. 5,481,255 and U.S. Patent No. 5,452,356 both describe data encryption methods and techniques that can be used with the data described herein.

[0275] For example, data received from a thermometer can be encoded and / or encrypted into one or more data packets for transmission. The microprocessor can encode the data and then transmit the packet by driving a piezoelectric speaker. As described above, frequency shift keying (FSK) can be used, where two separate ultrasonic frequencies (e.g., 18817 Hz and 19672 Hz) are used to transmit Boolean 0 and 1, respectively. The control logic (data ultrasonic modem logic) can configure, encode, and encrypt the data, and can also control the transmission of the prepared packet of encoded / encrypted data driven by the speaker (e.g., piezoelectric transducer). The control logic can also control the timing of the transmission so that there is sufficient spacing between each data bit. In addition, the control logic can also repeat the transmission and time the start of the transmission.

[0276] For example, in one variation, a thermometer typically measures temperature and, once the temperature has stabilized at a certain value, emits an audible beep to alert the user that the value can be read. The thermometer (in its initial, unmodified configuration) includes a microcontroller (e.g., AFE4110) and a piezoelectric speaker; the microcontroller drives the speaker to produce 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 the signal, such as a smartphone running the digital ultrasonic modem receiver logic.

[0277] In this example, the microprocessor may include the following (exemplary) code to implement the above functions. Figure 23 and Figures 24A to 24E A flow chart describing a method for transmitting data is shown. These examples are not limited to digital thermometers, but can be used with any of the devices described herein, including ECG transmission.

[0278] Although the above steps show Figure 23 and Figures 24A to 24E Although the present invention provides a method for transmitting data, those skilled in the art will recognize many variations based on the teachings described herein. These steps can be performed in a different order. Steps can be added or omitted. Some of these steps can include sub-steps. Many of these steps can be repeated as much as is beneficial.

[0279] Figure 23 and Figures 24A to 24E One or more of the steps of the method may be performed using circuitry as described herein (e.g., one or more processing devices or logic circuits of a computing device or its accessories). The processing device or logic circuit may be programmed to provide one or more of the steps of the method, and the program may include program instructions stored on a computer-readable memory or programmed steps of the logic circuit.

[0280] In any system, device, or method described herein, data (including digital, analog, and / or mixed digital / analog data) may be compressed before being encrypted. Any suitable data compression technique may be used. For example, lossy and / or lossless techniques may be used for data compression. Known types of lossy and lossless data compression may be used. For example, Lempel-Ziv (LZ) compression and other statistical redundancy techniques may be used for lossless compression. Similarly, lossy data compression techniques may also be applied. A receiver executing control logic may decompress the data.

[0281] As described above, a receiver (digital ultrasound modem receiver) can be used to receive the transmitted ultrasound signal. The receiver can be a dedicated device that includes a microphone assembly that receives the ultrasound signal and a processing device (e.g., a microprocessor) capable of analyzing the signal, or the receiver can be a device that includes a microprocessor and a microphone that is adapted to receive the ultrasound signal while executing control logic (e.g., digital ultrasound modem receiver logic).

[0282] For example, Figure 25 The example illustrates a variation of a flow chart for a method for receiving, demodulating, and detecting a digital ultrasound signal. In this example, the application (receive control logic) receives binary FSK encoded data via a microphone input. For example, the input can come from a microphone on a smartphone. As described above, binary FSK encoding uses a "mark" frequency Fr representing a binary 1 and a "space" frequency Fr representing a binary 0. s These two frequencies. In this implementation, no carrier wave is used.

[0283] The application consists of two largely independent components: a demodulator, which extracts the mark and space frequency components from the raw audio data; and a packet decoder, which monitors the demodulated signals for packet transmissions and decodes them. Figure 25 The demodulator receives audio samples from the microphone hardware at a sampling rate S, such that S>2*max(F m9 F8). The audio samples are processed by two frequency detectors that calculate the strength of the mark and space frequency components of the received signal (respectively). In this implementation, the Goertzel algorithm is used for frequency detection. In order to achieve sufficient frequency resolution between mark and space frequencies, the Goertzel algorithm is applied to a sliding window of G samples, where G = S / abs(F m -F).

[0284] The Goertzel algorithm's outputs for the mark and space frequencies are passed through separate low-pass filters with passbands 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 occurring, rises to a positive value when the "mark" frequency is active, and falls to a negative value when the "space" frequency is active.

[0285] This demodulated waveform is then passed to the 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 equals the length of the synchronization sequence. For each new sample, the decoder evaluates the past N samples in the buffer to determine whether they contain the synchronization sequence. A two-stage test is used: first, a computationally simple evaluation that eliminates most false positives due to random noise, followed by a computationally more expensive evaluation that eliminates the remainder.

[0286] Once a valid synchronization sequence is received, the decoder stores the properties of the received signal (e.g., maximum mark / space amplitude, etc.). These equalization parameters are used to calibrate the decoder thresholds used to read the remainder of the packet. The decoder in this example then reads each encoded byte in turn. The decoder uses the stored equalization parameters to determine the minimum amplitude threshold for the start bit of each byte. Once a valid start bit is received for a given byte, subsequent bits are evaluated based on the sign of the demodulated waveform in the absence of a minimum threshold for decoding.

[0287] If a valid start bit is not received, the decoder stops reading the packet and waits for silence, or until a fixed amount of time has passed, before continuing to listen for new packets. Each logical byte in a packet is actually transmitted as two encoded bytes: the first byte contains the lower nibble of the Hamming encoding of the logical byte, and the second byte contains the upper nibble of the Hamming encoding.

[0288] The first logical byte read is the packet version, which is checked against 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.

[0289] After reading the data bytes, two logical checksum bytes are read and the received checksum value is compared with the value calculated for the received data bytes. If the two checksum values match, the packet is considered valid and can be used for the rest of the application. If the two checksum values do not match, the packet is rejected. The two logical checksum bytes indicate the end of the packet. After receiving the packet, the decoder resumes listening for new packets.

[0290] Once the data is received (and, in some variations, decrypted), it can be further processed and / or stored and / or displayed and / or transmitted using any communication capabilities of the telecommunications device. For example, the data can be displayed on a smartphone and / or uploaded to a medical database for storage and / or later viewing.

[0291] Although the above steps show Figure 25 Although the present invention provides a method for transmitting data, those skilled in the art will recognize many variations based on the teachings described herein. These steps can be performed in a different order. Steps can be added or omitted. Some of these steps can include sub-steps. Many of these steps can be repeated as much as is beneficial.

[0292] Figure 25 One or more of the steps of the method may be performed using circuitry as described herein (e.g., one or more processing devices or logic circuits of a computing device or its accessories). The processing device or logic circuit may be programmed to provide one or more of the steps of the method, and the program may include program instructions stored on a computer-readable memory or programmed steps of the logic circuit.

[0293] Although the above examples describe systems configured to transmit digital information, the techniques, devices, and systems described herein may also be configured to transmit analog signals and / or mixed analog and digital signals. Typically, the techniques described include using a timer (e.g., in a microcontroller) to transmit 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 non-digital output. Furthermore, in some variations, the output system is not a piezoelectric element, but a more traditional speaker (although within the ultrasonic range). Additional digital-to-analog (D / A) conversion may occur during transmission.

[0294] For example, Figure 26A and Figure 26B One variation of a hybrid digital / analog format that can be used with an ultrasound transmitter is illustrated. Generally, a signal can include a digital component that is modulated or configured for transmission by an ultrasound modem. For example, the digital signal can be encoded as an FSK signal, and data (e.g., analog data such as biometric data such as ECG, blood oxygen / pulse oximetry, etc.) can be encoded as a frequency modulated waveform appended to the digital information.

[0295] For example, in some variations, the ultrasonic transmission device is configured as a pulse oximetry / monitoring device. In this example, information obtained from the pulse oximetry can be examined to extract information such as minimum values, maximum values, duration of the analog signal, etc., and can be digitally encoded (using one or more encryption and / or error correction codes) and placed in a buffer and / or transmitted via ultrasound. The analog signal can be combined with a digital signal (or extracted signal) that can be sent to a transmission element and received by a telecommunications device. In the example of a device configured as a pulse oximetry device (e.g., a plethysmograph), the pulse oximetry device prepares a mixed data / analog signal by determining the peak values, minimum values, duration, time intervals, etc. of the analog signal from the analog signal (e.g., a time-varying pulse oximetry signal). Thus, the mixed signal can include the extracted or labeled digital information and the waveform (or multiple waveforms) obtained from the device.

[0296] In some variations, the signal may be ECG data. The ECG header information may include digital information related to the analog waveform appended to the digital information, such as duration, pulse rate, and information related to the ECG waveform (if previously analyzed) such as interval data.

[0297] The signal may be sent encrypted with a device or user-specific identification code. Generally, any device described herein may encode data and provide an encryption key so that it can be read and understood by a receiving telecommunications device (e.g., a phone, tablet, pad, etc.).

[0298] There are many potential benefits to transmitting a hybrid analog / digital signal that can be read and understood by telecommunications devices. For example, if the hybrid signal includes a range of values (e.g., min / max) and a waveform (e.g., ECG, heart rate, etc.), such a hybrid digital / analog system can allow for more efficient communication than FSK value data alone.

[0299] For example, variations of the ultrasonic transmitter may include pedometers, activity monitors, heart rate monitors, and the like. In some variations, the signal is formatted so that there are a limited number of points in the analog portion. The ultrasonic transmitter may then transmit a series of data points (including any calibration points). In one example, a graph of heart rate may include 1000 points over 2 seconds (the transmission time) representing a graph of biometric data over time. The signal may include digital values (e.g., encoded as FSK) and analog (e.g., graphical) data. Such a hybrid signal may include the best characteristics of both a digital-only signal and an analog-only signal.

[0300] In one example, as previously mentioned, the ultrasonic transmission device is a thermometer that includes the ultrasonic modem element described above. The ultrasonic thermometer device can be configured to include a temperature range of approximately 95°F and 106.7°C for practical use. Therefore, the temperature can typically be transmitted with a resolution of 0.1 (e.g., 120 values, so 8 bits may be all that is needed). In a device configured to encode biometric data in a mixed signal, the digital component of the signal can be appended first, and the digital component can include information related to the analog signal that follows the digital signal alone, while the analog signal can be appended or embedded in the rest of the signal, and the digital information can be extracted from the digital signal that also includes the digital information. An example of a mixed signal can include a thermometer device as described above that displays temperature as a function of time and measures and / or records and transmits the maximum / minimum temperature, the time measured, etc. The final signal can also include a temperature waveform showing the time course. Other devices and / or signals (mixed signals) may include blood glucose monitoring signals (for example, configuring the ultrasonic transmission device as a blood glucose meter, etc.), which can send blood glucose signals (including digital signals of maximum value, minimum value, etc.) and one or more graphs showing the waveform of blood glucose over time, etc.

[0301] Preparing and transmitting the signal to include both analog and digital information can also allow the system to send more data in a compressed form as a waveform, which can be very efficient. For example, the prototype ultrasonic transmitter uses 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 sent in a compressed form as a waveform. Including extracted information (such as the minimum and maximum values of the analog signal) in the digital portion of the signal can provide axis calibration for the analog portion of the signal for display, for example.

[0302] As mentioned, Figure 26A One variation of a hybrid digital / analog format that may be used as described herein is shown. In this example, the signal includes an initial digital component 0901 that is encoded for ultrasonic transmission using a technique such as FSK (or any other technique known in the art). The digital information may be appropriately divided into bits, bytes, words, etc. The size and location of the digital information may be predetermined. Error correction codes (e.g., Hamming codes, etc.) may be included. Figure 26A In the example, the signal includes a start bit or byte 0905, a calibration data sequence 0907 extracted from the analog signal (e.g., maximum / minimum values), and additional data 0909 on the analog signal (e.g., type, timing, data stamp / time stamp, etc.). Any other digital information may be included. Afterwards, the signal may include an analog component 0903. Figure 26AIn [1], the analog signal is slightly open-ended and may last for a fixed or variable duration; in some variations, the entire signal may be repeated for reception by a telecommunications device. Figure 26B A similar variation of the mixed signal format is shown, where digital component 0901 is appended to analog component 0903, and an additional digital component 0911 ("end" signal) can be appended at the end. In some variations, multiple analog components can be combined with multiple analog components. As described below, the entire signal can be encrypted before transmission.

[0303] In some variations, a hybrid digital / analog format can be used to encode stored data that has been maintained by a device (ultrasonic transmission device) for a period of time. For example, stored data such as hourly, daily, or weekly data (e.g., biometric data such as pedometer data) can be prepared as an analog signal (a graph over time) described / calibrated by a digital data component and transmitted to a telecommunications device.

[0304] In any of the devices, systems, and methods described herein, the ultrasonic signal transmitted by the device can be encrypted. Any suitable encryption method can be used, including encryption methods using keys, such as the Data Encryption Standard (DES) and the Advanced Encryption Standard (AES).

[0305] Typically, an encryption key for a particular device (e.g., an ultrasonic transmission device) can be presented on the device (or on the device's associated packaging, housing, etc.) such that the encryption key can be easily accessed by a user of the receiving telecommunications device. The encryption key can be prepared as a barcode or other machine-readable format (e.g., a QR code), and in particular, a readable format that can be read using the receiving telecommunications device in a modality other than ultrasonic transmission. As used herein, reference to presenting or displaying the encryption key on the ultrasonic transmission device is intended to include displaying the prepared representation (particularly a machine-readable representation) on the ultrasonic transmission 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 exterior of the ultrasonic transmission device such that the encryption key can be photographed or scanned by the telecommunications device. Machine-executable logic (e.g., client logic, software, firmware, etc.) on the telecommunications device can then determine the encryption key and apply the encryption key to decrypt ultrasonic signals received from the ultrasonic communication device.

[0306] In this manner, an ultrasonic transmission device can be uniquely paired with a private encryption key that can only be read by the telecommunications device that possesses and applies the encryption key. The encryption key is easily displayed and determined by the telecommunications device. Thus, in some variations, each ultrasonic transmission device may have a unique ID printed on the device, thereby providing a code that must be matched to the telecommunications device. Scanning the printed encryption key allows the telecommunications device to decrypt the data.

[0307] Figure 27 The schematic illustrates a variation of a system comprising an ultrasonic transmission device ("source device" 01031) having an encryption key 01051 visible on the body of the device, which can be read and applied by telecommunication device 01025 to decrypt the transmitted ultrasonic transmission. Figure 27 Also illustrated is a variation of the device and system in which an ultrasonic transmission device ("source device" 01031) is in two-way (or limited two-way) communication with a telecommunication device.

[0308] As described above, it may be useful to communicate between a telecommunication device (e.g., a smartphone or computer) and an ultrasonic transmission device (such as a healthcare / fitness sensing device, a home automation and security device (door and window sensors, remote light switches, etc.), a factory water level detector, etc.). For example, it would be helpful to implement a half-duplex protocol so that the telecommunication device (e.g., smartphone / computer) can provide an acknowledgment (ACK) of successful receipt of data (with a correct CRC) to the sensing device (source device or ultrasonic transmission device) and stop retransmitting the data. Another use of this half-duplex protocol would be to configure a remote device by sending parameters or information (such as calibration data, personal information, etc.) from the telecommunication device.

[0309] For simple confirmation, the piezoelectric / speaker used by the device (ultrasonic transmitter) to transmit data can be used as a frequency-tuned sensor. Typically, the piezoelectric element used to transmit sound can also be configured as a receiver. Using a piezoelectric element as a receiving sensor requires a relatively "loud" signal (even if the signal is inaudible), so the signal should be at the resonant frequency of the most sensitive piezoelectric element. The duration or encoding of this "frequency burst" can be configured so that it can be easily recognized by the low-power electronics of the healthcare / fitness sensing device. For example, the confirmation pulse can be filtered and detected as only the presence of a specific ultrasonic frequency for a predetermined duration.

[0310] In some variations, symmetrical two-way communication can be achieved using established telephone modem technology, whereby only the carrier frequency is changed to within the ultrasonic range. For example, telephone modem modulation techniques are based on FSK (Frequency Shift Keying), QAM (Quadrature Amplitude Modulation), and PSK (Frequency Shift Keying). These telephone modem techniques assume that only two devices are attempting to communicate. Radio frequency protocols can be used to enhance the modem protocol to allow multiple devices to communicate simultaneously without errors.

[0311] Implementations of this two-way communication technology may include additional processing power in the device sufficient to perform the signal processing required 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 may be suitable for ultrasonic communication may include ITU V.21 (300 bps, FSK) and ITU V.22 (1200 bps, PSK (Phase Shift Keying)). For example, see reference web pages such as the following:

[0312] ftp: / / kermit.columbia.edu / kermit / cu / protocol.html,

[0313] http: / / www.LSU.edu / OCS / its / unix / tutorial / ModemTutorial / ModemTutorial.html,

[0314] http: / / www.dtic.mil / cgi-bin / GetTRDoc?AD-ADA499556,

[0315] http: / / alumni.media.mit.edu / ~wiz / ultracom.html,

[0316] http: / / nesl.ee.ucla.edu / fw / torres / home / Dropbx / good_paper_mico_controller.pdf,

[0317] http: / / edocs.nps.edu / npspubs / scholarly / theses / 2010 / Sep / 10Sep_Jenkinds.pdf.

[0318] about Figure 27The source device may include an additional transducer / microphone for receiving ultrasonic signals from the telecommunications device and supporting processing (e.g., microprocessor / microcontroller logic) for controlling the ultrasonic signals, interpreting the communications (which may be encoded and / or encrypted), and executing any command functions. Similarly, the telecommunications device may include a speaker (piezoelectric element) configured to transmit ultrasonic signals.

[0319] From the foregoing description, it is clear that the presently disclosed and claimed inventive concept(s) are well adapted to achieve the objectives and obtain the advantages mentioned herein, as well as the advantages inherent in the presently disclosed and claimed inventive concept(s). Although the presented embodiments have been described for the purposes of the present invention, it will be appreciated that many changes may be made that will readily suggest themselves to those skilled in the art and that are accomplished within the spirit of the presently disclosed and claimed inventive concept(s).

[0320] Example 2: Heart Rate Monitor Using Audio Tones for Heart Rate Transmission

[0321] Any of the devices, systems, and methods described herein can be configured as a wireless (ultrasonic) heart rate monitor for use with a mobile telecommunications (computing) device, such as a smartphone, etc. See also Example 3 below, which describes a wearable ECG monitor that can also provide heart rate information (e.g., by extracting heart rate from a detected ECG signal). The wearable component for sensing heart rate (e.g., a wearable monitor) can be configured as a wristband, anklet, armband, chest strap, waistband, etc. (collectively, a "strap") and can transmit information wirelessly via any of the ultrasonic methods described above, including using receiving control logic (e.g., software, hardware, etc.) to receive, store, and / or analyze the sensed (biometric) information.

[0322] Most heart rate monitors consist of a chest strap that incorporates an ECG amplifier, an R-wave detector, and circuitry for outputting 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 intervals between pulses and calculates and displays the heart rate. This configuration requires a special receiver that may not be present in a mobile phone or computer, so the mobile phone or computer cannot receive heart rate information without additional equipment. The range is also limited to approximately 1 meter because near-field electromagnetic transmission is typically used.

[0323] In one variation of the devices and systems described herein, a heart rate monitor may include a strap (e.g., a chest strap, a wristband, etc.) incorporating an ECG amplifier, an R-wave detector, and circuitry for outputting a typically 5 ms wide audio frequency (signal) when an R-wave is detected (e.g., in the ultrasonic frequency region of approximately 17 kHz to 30 kHz). The audio tones may be detected by a device such as a smartphone or other mobile computing device using a built-in microphone on the smartphone device, and the intervals between the tones may be measured and the heart rate calculated and displayed. The mobile computing device (e.g., a phone) may include software, firmware, or hardware (although typically software, including applications or "apps" that may be downloaded from a remote server) for controlling the mobile device to receive and analyze the audio (e.g., ultrasonic) tones, calculate the heart rate, and store, upload, and / or display the heart rate.

[0324] An advantage of this system is that no additional equipment is required to receive the heart rate information since the microphone circuitry is already present in the smartphone or other mobile computing device, and the range can be longer, 5m or more if desired, depending on the loudness of the audio tone.

[0325] When audio tones within the range of 16kHz to 32kHz are used (e.g., ultrasound, 17kHz to 30kHz, 17kHz to 22kHz, etc.), these audio tones are inaudible to most people, do not interfere with music or speech, and are less susceptible to audio interference.

[0326] In some variations, the devices, methods, and systems may be configured so that multiple heart rate monitors can be used in close proximity, or a single receiving device can receive heart rate information from multiple users simultaneously. It may be desirable for the heart rate information from each heart rate monitor to be uniquely identifiable so that the heart rate information does not interfere with each other.

[0327] For example, the audio tones from each cardiac monitor may be uniquely encoded for each monitor by using a series of tone durations, multiple tones of the same frequency with specific time intervals, different audio frequencies, or a combination of these.

[0328] The first embodiment is one in which each heart monitor uses a different audio frequency that is sufficiently spaced apart to allow for Doppler shifts when the heart rate monitor moves rapidly relative to the receiver, and to allow for frequency discrimination with a high signal-to-noise ratio.

[0329] Therefore, each heart monitor does not need to be set to a specific tone frequency. When the heart monitor first detects an R-wave heartbeat signal after being worn for the first time, the frequency can be determined by a pseudo-random sequence. The audio tone is then fixed until the heart monitor is removed. Therefore, each monitor does not need to be uniquely coded.

[0330] In the case where the audio tones emitted by the heart rate monitor are in the range of 18kHz to 22kHz, a separation of 500Hz can be used. This allows for 9 possible audio operating frequencies for each monitor.

[0331] Pseudo-random assignment of the frequency to use can be achieved by having a counter that increments over time from when the cardiac monitor is first attached to the body, so that the counter value when the first R-wave is detected determines the audio frequency to use. The audio frequency can be changed by detaching and reattaching the monitor from the body.

[0332] In the above example, in the rare case where two heart monitors are using the same frequency and are in close proximity so there is some possibility of interference, the frequency of one monitor can be changed by removing and reattaching it. The receiving device can also detect this interference and, if necessary, advise the user to remove and reattach the monitor.

[0333] The receiving device can determine the audio tone frequency of a specific ultrasonic transmitting device (in this example, a heart monitor) by performing a spectral analysis of the received audio. Once the audio tone frequency is known, a narrow audio filter is used to separate the tones from each heart monitor. The audio tones can then be detected, and the heart rate can be calculated by measuring the intervals between the audio tones. Since the duration of each audio tone is fixed, this information can be used to suppress interference from other audio sources in the frequency band.

[0334] A second embodiment is one in which multiple devices (e.g., heart rate monitors) use audio tones of the same frequency but with 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 of a particular heart rate monitor. In the event that two heart rate monitors are in close proximity, such that the receiving device picks up audio tones from both monitors simultaneously, it is possible to distinguish between the two based on the tone duration. It is unlikely that the audio tones will arrive at the same time because the tone duration is short compared to the interval between the tones (the heart rate interval), but if the audio tones do arrive at the same time, this can be recognized by the receiving device, and the heart rate calculation can be adjusted to compensate.

[0335] In some embodiments, the audio signal emitted when a heartbeat is detected may be digitally encoded (e.g., comprising a burst of multiple pulses at a high frequency), and as described above, the encoding (burst pattern) may be unique or pre-selected (random) and reset by the user (e.g., by removing the device and reapplying it).

[0336] Any of the examples discussed above may be included as part of a method, apparatus, or system (including software). Thus, a system for measuring heart rate may include a monitor (e.g., a heart rate sensor, etc.) that includes a transducer for generating an audio signal (e.g., one or more pulses) timed with the patient's heart rate. Thus, the monitor acts as an audio repeater. The audio signal may be within the ultrasonic range. The system may also include control logic to control a mobile device, such as a smartphone or tablet, to receive and analyze the audio signal timed with the user's pulse rate. In some cases, a dedicated receiver may be used instead of or in addition to a smartphone running the control logic.

[0337] In a particular example, the system may include an application for use on a mobile device such as a smartphone that controls the smartphone to use an internal audio pickup (microphone) to receive audio signals emitted by a sensor and calculate heart rate based on the audio (e.g., ultrasonic) pulse signals.

[0338] Example 3: Wristband for detecting motion and / or ECG signals

[0339] Figure 28A and Figure 28B Another variation of an exemplary wearable device can detect health parameters and transmit the health parameters ultrasonically to a monitoring station (e.g., a smartphone) controlled by control logic, such that the monitoring station receives information and / or causes receipt of information from the wearable device ultrasonically.

[0340] Figure 28A A diagram showing a variation of a device configured as a wristband. The device may include one or more sensors for detecting biological parameters, such as motion / vibration sensors, and one or more electrodes. Figure 28A , the outer surface of the device is schematically shown. A first conductive (e.g., metal) window 01151 is visible on the outer surface of the wristband, and a second conductive (e.g., metal) window 01153 is visible on the inner surface of the wristband. These electrodes can allow the user to press down on the electrodes and wristband to make electrical contact with the skin. The inner electrodes can make constant or periodic contact during normal use. The conductive windows can also be thermally conductive and can also be connected to the temperature sensing module.

[0341] The wristband can be flexible so that it can be extended over and secured to the wearer's wrist. The wristband can be bendable so that once bent around the wearer's wrist, it remains in place. In some variations, the wristband is open; in some variations, the wristband can be closed (forming a closed loop around the subject's wrist). The outer surface of the wristband can be sealed to the inner surface to prevent damage and to make the wristband sweat-proof and waterproof when worn.

[0342] As shown above for the conductive window area, the outer portion of the wristband can be adapted to transmit energy from the module within the wristband through the outer protective shell. For example, the conductive window area is shown above. The area of the wristband covering the ultrasonic transducer 01184 can also be adapted to allow the passage of ultrasonic signals. In some variations, the ends of the wristband are adapted to allow the passage of ultrasonic signals by including relatively rigid end caps that can easily convert ultrasonic energy. In some variations, the outer (e.g., polymer) covering is made of a relatively ultrasonically transparent material known in the art. In some variations, the end region (or relative end regions) can also be adapted to allow the battery of the device to be recharged.

[0343] Figure 28B An exemplary internal schematic diagram of a wristband illustrating an internal module (structure). As described above, any suitable sensor(s) may be included, including any of the sensors described above. In this example, the wristband includes a motion sensor 01186, which may be a high-precision motion sensor for tracking body movement. Other sensors in this example include a first electrode 01191 and a second electrode 01192 that may be electrically connected to conductive windows 01151, 01153 on the outer surface. In some variations, the outer surface is an electrode(s). In other variations, the conductive surface (e.g., for the lower electrode) extends around the length of the inner surface of the wristband so that it may contact at least a portion of the exposed skin of the wrist whenever the device is worn. Similarly, the outer conductive surface of the upper electrode may extend completely around the outer (outward-facing) surface of the wristband. Additional sensors may be included or omitted. For example, in one variation, the wristband includes only a motion sensor but no electrodes.

[0344] In some variations, the wristband further includes a tactile feedback element, namely a vibration motor 01194. The vibration motor can generate an oscillating frequency to provide feedback from the device to the user. In some variations, the wristband can also include buttons or contact areas that allow the user to manually trigger one or more functions of the wristband and / or monitoring station (such as transmitting data via ultrasound, etc.). The buttons can be pressed or activated through the protective outer covering of the wristband, and the outer covering can indicate where the button can be pressed by using patterns or colors, etc.

[0345] The wristband may also include a processing device 01183 for receiving and / or encoding information from one or more sensors, and an ultrasonic transducer 01184. As discussed above, the transducer may receive encoded / encrypted information from the processing device for transmission via ultrasound. When multiple sensors are included, the information may be encoded to indicate what data is included.

[0346] One or more memory modules (not shown) may also be included to store recorded information. The memory may be integrated with the processing device. In some variations, a separate ultrasonic detector 01194 may also be used, or the ultrasonic transducer 01184 may be a component capable of transmitting and receiving ultrasonic signals. Thus, two-way communication via ultrasound may be possible between the device and a monitoring station (e.g., a smartphone running the control logic).

[0347] The wristband may also include a power management system including a typically rechargeable battery 01182. The battery may be relatively low power (e.g., a low voltage such as 1.5V) sufficient to power the electronics and ultrasound transducer. The processing device may manage power (including charging the battery). The system may indicate (e.g., by vibrating in a vibrating warning pattern) that the battery is low and needs to be recharged.

[0348] In operation, the wristband can be worn and used to monitor the subject (e.g., physical activity), and can record and / or wirelessly transmit the subject's sensed values. For example, motion sensor data can be detected by ultrasound and transmitted to a mobile computing device (e.g., a smartphone 01130). As discussed above, the sensed data can be encoded (e.g., as analog and digital information) and encrypted, which can prevent interference between other devices (e.g., allowing specific keying between devices) and also allow error correction.

[0349] For example, a wristband device (e.g., an activity monitor) can be worn by the subject. When the wristband device is worn, the device can record the wearer's movements (activities). The device can also include additional sensors such as a pair of electrodes. When the subject presses down on the outer surface of electrode 1, these electrodes can be used to measure the ECG on the patient (e.g., between the patient's arms). In some variations, pressing can also trigger the device to record the potential within that time period. The recorded electrical signals can include information related to the pulse and ECG, which can be directly transmitted on the processing device, or initially analyzed by the processing device and then transmitted on the processing device (including transmitting any analyzed information).

[0350] The device can be configured to transmit data continuously (e.g., via ultrasound broadcast) and / or repeatedly, or it can be configured to handshake with a smartphone (or other receiving station). For example, the wristband device can be configured to standby until the ultrasound transducer / detector (01184 / 01194) receives an ultrasound trigger ('ready'). The wristband can then communicate with the receiving station to transmit the collected data via encoded / encrypted ultrasound as described above. The system can be configured to transmit periodically, or to attempt to transmit when sufficient data has been collected.

[0351] In general, any of the techniques, components, and / or subsystems described above can be used or combined with any of the other examples. For example, any ECG wristband device described herein can include any of the features described above.

[0352] Example 3: ECG monitoring watch

[0353] exist Figure 29 and Figure 30 Another variation of an ECG measurement device configured to detect ECG signals and transmit an ultrasonic signal encoding the ECG data is shown in FIG. In this example, the watch has been modified to include two electrodes. The first electrode (at Figure 29 and 30 (not visible in the figure) is located on the back of the watch ("wristband") and contacts the wrist of the person wearing the device. Figure 29 As shown, the second electrode 01203 is located on the "front" of the watch 01201. Thus, the watch can be used as a single-lead ECG sensor, recording Lead I (left arm / right arm). In some variations, the watch can also include an additional electrode 01207, for example on the side of the watch or band area, which can be held against the subject's leg (right leg or left leg) to produce (one or more than one) additional / alternative lead (e.g., Lead II, Lead III, etc.).

[0354] The watch may also include one or more controls and / or indicators. For example, the watch may also be configured as a clock (showing the time, etc.). The watch may include buttons, dials, etc. to select functions (e.g., turning on / off ECG reading, starting to transmit ECG information, etc.).

[0355] Figure 30 Show Figure 29 01205 . In this example, the mobile telecommunications device is a smartphone (iPhone™) configured to act as a receiving station for the ECG watch and receive ultrasonic transmissions of ECG information. Thus, the smartphone is running application software that causes the smartphone's processing device to cause an ultrasound-sensitive audio receiver (microphone) to "listen" to the ultrasound signal. The receiving device (smartphone) can then process the signal and, as the ECG signal is being recorded, Figure 30 These ECG signals are shown in real time. In this example, the smart phone is continuously receiving, displaying and recording the signals.

[0356] As described above, the signal can be processed before being displayed and / or stored and / or transmitted. For example, the signal can be filtered to remove artifacts and / or smoothed. The signal can also be analyzed to automatically detect cardiac events (e.g., arrhythmias). The processing can be performed before the ultrasound transmission using the watch, after transmission to the receiving device (e.g., a smartphone), or distributed between the two.

[0357] In some variations, as described above, the watch can determine / confirm that the receiving device (e.g., a smartphone) is ready to receive information. In some variations, half-duplex or full-duplex communication can be used. The watch can continuously broadcast ECG data, or it can transmit only when the receiver indicates it is ready to receive; in such variations, the device can store the detected ECG data for later transmission.

[0358] exist Figure 29 and Figure 30 In the example shown, the system also determines heart rate based on ECG information. Additional information can also be extracted from the signal. As described above, the signal can be transmitted by the device (e.g., a wristband) as a digital, analog, or hybrid digital / analog ultrasound signal. In addition, the signal can be encoded; in some variations, as described above, the device includes a key that can be scanned by a smartphone to provide a decryption / pairing key between the smartphone (receiver) and the device.

[0359] Although many of the exemplary devices described herein are wearable devices (e.g., wristbands, chest straps, pendants, jewelry, etc.), the principles, modules, subsystems, and components described herein can be used in other devices, particularly biosensor devices. For example, a housing or holder for a mobile telecommunications device (e.g., a smartphone) can incorporate any of these aspects, such as encoding of ultrasonic signals or encoding into a hybrid digital / analog ultrasonic signal. Thus, in addition to wearable medical sensors, any stand-alone medical sensor can also include any of these features.

[0360] When a feature or element is referred to as being "on" another feature or element in this article, the feature or element can be directly on the other feature or element, or there can be intermediate features and / or elements. On the contrary, when a feature or element is referred to as being "directly on" another feature or element, there are no intermediate features or elements. It should also be understood that when a feature or element is referred to as being "connected," "attached" or "coupled" to another feature or element, the feature or element can be directly connected, attached or coupled to the other feature or element, or there can be intermediate features or elements. On the contrary, when a feature or element is referred to as being "directly connected," "directly attached" or "directly coupled" to another feature or element, there are no intermediate features or elements. Although described or shown with respect to one embodiment, the features and elements described or shown in this manner can be applied to other embodiments. Those skilled in the art will also understand that a reference to a structure or feature that is "adjacent" to another feature can have a portion that overlaps with an adjacent feature or is located under an adjacent feature.

[0361] The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit the present invention. For example, as used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising" when used in this specification specify the presence of the features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more than one of the associated listed items and may be abbreviated as " / ".

[0362] Spatially relative terms such as "below," "lower," "above," and "upper" may be used herein to facilitate description of the relationship between an element or feature as shown in the figures and (one or more than one) another element or feature. It should be understood that, in addition to the orientation shown in the figures, spatially relative terms are intended to cover different orientations of the device in use or operation. For example, if the device in the figure is inverted, elements described as "below" or "below" other elements or features will be oriented as "above" other elements or features. Thus, the exemplary term "below" can cover both upper and lower orientations. The device can be oriented in other ways (rotated 90 degrees or in other orientations), and the spatially relative descriptors used herein are interpreted accordingly. Similarly, unless otherwise specifically stated, the terms "upward," "downward," "vertical," and "horizontal" are used herein for explanation purposes only.

[0363] Although the terms "first" and "second" may be used herein to describe various features / elements, these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element discussed above could be referred to as a second feature / element, and similarly, a second feature / element discussed above could be referred to as a first feature / element, without departing from the teachings of the present invention.

[0364] As used herein in the specification and claims (including as used in the examples, and unless otherwise expressly stated), all numbers can be interpreted as beginning with the word "about" or "approximately", even if the term does not explicitly appear. The phrase "about" or "approximately" can be used when describing size and / or position to indicate that the value and / or position described are within the reasonable expected range of value and / or position. For example, a numerical value can have a value of + / - 0.1% of the value (or value range), + / - 1% of the value (or value range), + / - 2% of the value (or value range), + / - 5% of the value (or value range), + / - 10% of the value (or value range), etc. Any numerical range described herein is intended to include all subranges included therein.

[0365] Although preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that these embodiments are provided by way of example only. Many variations, changes, and substitutions will now occur to those skilled in the art without departing from the present invention. It should be understood that various alternatives to the embodiments of the present invention described herein may be used to implement the present invention. The appended claims are intended to define the scope of the present invention and are intended to encompass methods and structures within the scope of these claims and their equivalents.

[0366] Figure 31 is a flow chart of a method 3101 for performing a 12-lead ECG using a three-electrode device according to some embodiments of the present invention. The method 3101 may be performed by processing logic including hardware (e.g., circuitry, dedicated logic, programmable logic, microcode, etc.), software (e.g., instructions running on a processing device to perform hardware simulation), or a combination thereof. In one embodiment, the method 3101 is performed by processing logic including hardware (e.g., circuitry, dedicated logic, programmable logic, microcode, etc.), software (e.g., instructions running on a processing device to perform hardware simulation), or a combination thereof. Figures 1 to 30 The processing logic corresponding to one or more components or methods of the present invention may perform one or more of the following operations. For example, in one embodiment, the processing logic of the processing device 1110 may be related to Figures 1 to 30 The components and operations of the present invention perform the following operations. In another embodiment, any other suitable processing device can perform the described operations.

[0367] refer to Figure 31At block 3103, processing logic may determine Lead I (value) based on the first electrical signal from the first electrode and the second electrical signal from the second electrode. Lead I may be calculated according to any of the methods described herein. For example, Lead I may be calculated based on the electrical signal from the first electrode contacting the user's first upper limb and the second electrode contacting the user's second upper limb. At block 3105, processing logic may determine Lead II based on the second electrical signal and the third electrical signal from the 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 the electrical signal from the second electrode contacting the user's second upper limb and the third electrode contacting the user's first lower limb. In one embodiment, Lead I and Lead II are measured sequentially (e.g., the user first places the electrode for Lead I, obtains a measurement, then places the electrode for Lead II and obtains a corresponding measurement). In this case, processing logic may further time-align Lead I and Lead II. In another embodiment, Lead I and Lead II are measured simultaneously (e.g., the user places the electrodes for Lead I and Lead II, and obtains both measurements simultaneously, concurrently, or substantially simultaneously).

[0368] At box 3107, processing logic may generate Lead III (e.g., using Lead III = Lead II - Lead I). In another embodiment, Lead III may be generated directly from the electrical signals of the electrodes contacting the user. At box 3109, processing logic may be performed by a processing device to determine Leads aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 based on Lead I, Lead II, and Lead III using a machine learning model trained using the measured 12-lead ECG data. In one embodiment, only Lead I, II, and III data are provided to the machine learning model, which uses only Lead I, II, and III data to provide a 12-lead output. In another embodiment, as described below with respect to Figure 32 As mentioned, the model can use additional data.

[0369] In another embodiment, the processing logic may use non-machine learning-based techniques to determine leads aVR, aVL, and aVF from leads I and II. In yet another embodiment, the processing logic may also determine lead V based on the fourth electrical signal. For example, the processing logic may determine lead V2, V5, or any other V lead based on the fourth electrical signal. The processing logic may then use a machine learning model trained using the measured 12-lead ECG data by the processing device to determine lead V and the remaining V leads based on leads I, II, III, and V.

[0370] At block 3111, processing logic may provide the leads, namely, Lead I, Lead II, Lead III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6, for display on the client device. In another embodiment, a subset of the twelve leads (or none of the twelve leads) may be provided.

[0371] In one embodiment, a machine learning model is constructed based on a deep convolutional structure. The input layer processes the multi-lead ECG into a spatial image, where one dimension is used for the time axis and the other dimension is used for multiple channels. The ECG channels can have a regular order of leads I, II, III, aVR, aVL, aVF, V1-V6. Alternatively, the ECG channels can have a more physiologically meaningful order called the "Cabrera format", where the order of the frontal plane leads is leads aVL, I, -aVR, II, aVF, III, V1-V6. In another input format, only the Cabrera format limb leads and one actual measured precordial lead are used to form the input ECG image.

[0372] Instead of a 1D convolutional model as used by most other ECG training models, a 2D convolutional layer can be used to process the input ECG image. The training model can include 4 to 10 convolutional / residual layer blocks, followed by 2 to 4 fully connected layers. The output layer is a multi-classification layer that recognizes more than one class (such as "myocardial infarction" and "left ventricular hypertrophy" or "right bundle branch block" and "inferior wall ischemia").

[0373] In one embodiment, a large labeled training set with many epochs is used to train the model. To prevent overfitting and improve generalization, random connection dropout and batch normalization can be used. The data is divided 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 a final performance check. First, a dataset is formed using an existing 12-lead diagnostic ECG database. A second dataset will be formed from actual sampled ECGs from the target device described herein. Transfer learning can be used to adjust only a few layers of the deep learning model for the second dataset.

[0374] Figure 32 is a flow chart of a method 3201 for performing machine learning training on a 12-lead ECG using a three-electrode device according to some embodiments of the present invention. The method 3201 may be performed by processing logic including hardware (e.g., circuitry, dedicated logic, programmable logic, microcode, etc.), software (e.g., instructions running on a processing device to perform hardware simulation), or a combination thereof. In one embodiment, the method 3201 is performed by a processing logic including hardware (e.g., circuitry, dedicated logic, programmable logic, microcode, etc.), software (e.g., instructions running on a processing device to perform hardware simulation), or a combination thereof. Figures 1 to 30The processing logic corresponding to one or more components or methods of the present invention may perform one or more of the following operations. For example, in one embodiment, the processing logic of the processing device 1110 may be related to Figures 1 to 30 The components and operations of the present invention perform the following operations. In another embodiment, any other suitable processing device can perform the described operations.

[0375] refer to Figure 32 At block 3207, processing logic may train a machine learning model using 12-lead ECG data corresponding to a population of individuals. In another embodiment, the model may be trained using data from a single individual (e.g., the user whose ECG is to be determined). In one example, the machine learning model may be trained to correlate measurement data from leads I, II, and III with the measured 12-lead data. Once trained, the machine learning model may accurately predict each lead of a 12-lead ECG using only data from leads I, II, and III.

[0376] Optionally, at box 3203, processing logic can pre-process the 12-lead ECG data before using it to train the machine learning model to classify the data based on at least one of height, gender, weight, and nationality. By pre-processing in this manner, the model can be trained more efficiently to provide more accurate results specific to the user for whom the 12-lead ECG is to be determined. For example, processing logic can classify the 12-lead ECG data based on individual characteristics (3205). In one embodiment, if the individual is identified as a male, the 12-lead ECG data can be pre-processed to include only data corresponding to male subjects. In another embodiment, if the individual is identified as having a specific nationality, the data can be pre-processed to include only that specific nationality. Using such pre-processed data to train the model can allow the model to be trained faster and provide more accurate results than previously possible results without such pre-processing.

[0377] In one embodiment, features of the 12-lead data can be selected, extracted, and labeled to predict a 12-lead ECG from three leads in real time, for example, by performing one or more machine learning operations. Such operations can be selected from the operations of ranking (one or more) features, classifying (one or more) features, labeling (one or more) features, predicting (one or more) features, and clustering (one or more) features. Alternatively or in combination, the extracted features can be labeled and saved for offline training of a machine learning algorithm or a set of machine learning operations. For example, an operation can be selected from any of the above operations. Any number of machine learning algorithms or methods can be trained to predict a 12-lead ECG from three leads. These can include using decision tree learning, association rule learning, artificial neural networks, inductive logic programming, support vector machines, clustering, Bayesian networks, reinforcement learning, representation learning, similarity and metric learning, or sparse dictionary learning, etc., such as using random forests.

[0378] The machine learning-based algorithms or operations for predicting a 12-lead ECG from three leads can be provided as a service from a remote server that can interact or communicate with a client program (e.g., as a mobile app) installed on a user's computing device. The interaction or communication can be through an application programming interface (API). For example, the API can provide access to machine learning operations for ranking, clustering, classifying, and predicting a 12-lead ECG from three leads.

[0379] Machine learning-based algorithms or operations provided by a remote server and / or a local application on a local computing device can operate, learn, and perform analytical predictions on, for example, 12-lead and / or three-lead data from a user population.

[0380] Comparison and analysis as described herein can be used to draw conclusions and insights into the patient's health status, which include potential health problems that the patient may experience when measuring or in the future. Conclusions and determinations can predict future health conditions or diagnose conditions that the patient has suffered from. Conclusions and determinations can also include insights into the effectiveness or risk associated with a medicine or drug that the patient may be taking, has taken, or may consider taking in the future. In addition, comparison and analysis can be used to determine the behavior and activities that may reduce or increase the risk of an adverse event. Based on comparison and analysis as described herein, ECG data can be classified according to the risk level of an adverse event. For example, ECG data can be classified as normal, low risk, medium risk, high risk, and / or abnormal. Normal and abnormal designations may require a healthcare professional to assess, diagnose, and / or confirm.

[0381] Diagnoses and determinations of abnormalities, adverse events, or disease states by doctors and other healthcare professionals can be transmitted to a server and database to be tagged with and associated with the corresponding ECG data. Diagnoses and determinations can be based on analysis of ECG data or determined using other tests or examination procedures. Professional diagnoses and determinations can be extracted from the patient's electronic health record, entered into the system by the patient, or entered into the system by a healthcare professional. The system's conclusions and determinations can be compared with actual diagnoses and determinations from healthcare professionals to validate and / or refine the machine learning algorithms used by the system. The time and duration of the abnormality, adverse event, or disease state can also be included in the database, so that ECG data corresponding to the occurrence and / or ECG data before and / or after the abnormality, adverse event, or disease state can be associated and analyzed. The length of time before or after the abnormality can be predetermined and can be as long as 1 to 30 days, or greater than 1 to 12 months. Analysis of the time before the abnormality, adverse event, or disease state can allow the system to identify patterns or correlations in various ECG features before the abnormality, adverse event, or disease state occurs, thereby providing early detection or warning of the abnormality, adverse event, or disease state. Analysis of the time following an abnormality, adverse event, or disease state can provide information regarding the efficacy of a treatment and / or provide the patient or physician with information regarding disease progression, such as whether the patient's condition is improving, worsening, or remaining the same, etc. Diagnoses and determinations can also be used for indexing by, for example, including them in metadata associated with the corresponding ECG data.

[0382] As described herein, various parameters may be included in the database along with the ECG data. These parameters may include the patient's age, sex, weight, blood pressure, medications, behavior, habits, activities, food consumption, beverage consumption, medications, medical history, and other factors that may affect the patient's ECG signal. Additional parameters may or may not be used to compare ECG signals over time and in context.

[0383] The conclusions, determinations, and / or insights about the patient's health generated by the system can be communicated to the patient directly or via the patient's caregiver (doctor or other healthcare professional). For example, an email or text message automatically generated by the system can be sent to the patient. The email or text message can be a notification directing the patient to log in to a secure site to retrieve the complete conclusion, determination, or insight, or the email or text message can include the conclusion, determination, or insight. Alternatively or in addition, the email or text message can be sent to the patient's caregiver. Notifications can also be provided via an application on a smartphone, tablet, laptop, desktop, or other computing device.

[0384] As described herein, the system can identify behaviors, habits, activities, food, beverages, medications and medicines associated with abnormal ECG readings of patients. In addition to notifying the patient of these associations, the system can also provide instructions or suggestions to the patient to avoid these behaviors, habits, activities, food, beverages, medications and medicines associated with abnormal ECG readings of patients. Similarly, the system can identify behaviors, habits, activities, food, beverages, medications and medicines associated with normal or improved ECG readings, and can instruct or recommend the patient to perform these behaviors, habits and activities and / or consume these food, beverages, medications and medicines. The patient can avoid future health care problems according to the system instructions or recommendations by modifying their behaviors, habits or by taking any course of action, including but not limited to taking medications, medicines or complying with a diet or exercise plan, which can be a predetermined course of action recommended by the system independent of any analysis of ECG data and / or can also be generated from the insights learned by the system and method as described herein. In addition, the insights of the system can relate to general health and / or mental health.

[0385] ECG data and associated metadata and other relevant data as described herein can be stored in a central database, a cloud database, or a combination of the two. The data can be indexed, searched, and / or sorted according to any of the features, parameters, or criteria described herein. The system can analyze ECG data for a single patient, and the system can also analyze ECG data for a group of patients that can be selected based on 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 the intra-individual variability of the ECG data so that a comparison of a set of ECG data acquired at a particular time with another set of ECG data acquired at another time reveals differences caused by changes in health status rather than changes in the type of ECG recording device used, changes in lead and electrode placement, and changes in skin condition (i.e., dryness, sweating, applied or unapplied conductive gel), etc. As described above, consistent lead and electrode placement can help reduce the variability of ECG readings. The system can also retrieve ECG data for patients acquired under similar circumstances and can analyze this subset of ECG data.

Claims

1. A device for generating a 12-lead electrocardiogram, comprising: an electrocardiogram device having a first electrode assembly, a second electrode assembly, and a third electrode assembly, wherein the first electrode assembly, the second electrode assembly, and the third electrode assembly respectively have first electrodes, second electrodes, and third electrodes adapted to measure a first electrical signal, a second electrical signal, and a third electrical signal of an individual; as well as Processing device for: Determine lead I according to the first electrical signal and the second electrical signal, determining Lead II according to the second electrical signal and the third electrical signal, Use Lead III = Lead II - Lead I to generate Lead III, pre-processing the measured 12-lead ECG data corresponding to a group of individuals to classify the measured 12-lead ECG data based on characteristics of the group of individuals, Using the preprocessed measured 12-lead ECG data to train a machine learning model, using the machine learning model, determining leads aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 based on the lead I, the lead II, and the lead III, and The lead I, the lead II, the lead III, and the leads aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 are provided for display on a client device.

2. The device according to claim 1, wherein Lead II and Lead I are determined sequentially.

3. The device according to claim 2, wherein The processing device is further configured to time-align Lead I and Lead II.

4. The apparatus according to claim 1, wherein Lead II is determined simultaneously with Lead I.

5. The apparatus according to claim 1, wherein The characteristic of the group of individuals is at least one of height, gender, weight and nationality.

6. The apparatus of claim 1 , wherein the processing device is further configured to train the machine learning model using only 12-lead ECG data corresponding to the individual.

7. A method for generating a 12-lead electrocardiogram, the method comprising: determining a lead I according to a first electrical signal of the first electrode and a second electrical signal of the second electrode; determining Lead II based on the second electrical signal and a third electrical signal from a third electrode; Use Lead III = Lead II - Lead I to generate Lead III; Determine leads aVR, aVL, and aVF based on leads I and II; preprocessing the measured 12-lead ECG data corresponding to the individual population to classify the measured 12-lead ECG data based on characteristics of the individual population; Using the preprocessed measured 12-lead ECG data to train a machine learning model; determining, by a processing device, Leads V1, V2, V3, V4, V5, and V6 based on Lead I, Lead II, and Lead III using the machine learning model; and Lead I, Lead II, Lead III, and Leads aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 are provided for display on a client device.

8. The method according to claim 7, wherein: Lead II and Lead I are determined sequentially.

9. The method according to claim 8, further comprising: Time align Lead I and Lead II.

10. The method according to claim 7, wherein: Lead II is determined simultaneously with Lead I.

11. The method according to claim 7, wherein: The characteristic of the group of individuals is at least one of height, gender, weight and nationality.

12. The method according to claim 7, wherein: Only the 12-lead ECG data corresponding to the individual was used to train the machine learning model.

13. A non-transitory computer-readable storage medium storing instructions that, when executed by a processing device, cause the processing device to: determining a lead I according to a first electrical signal of the first electrode and a second electrical signal of the second electrode; determining Lead II based on the second electrical signal and a third electrical signal from a third electrode; determining the V lead based on the fourth electrical signal; Determine leads aVR, aVL, and aVF based on leads I and II; Use Lead III = Lead II - Lead I to generate Lead III; preprocessing the measured 12-lead ECG data corresponding to the individual population to classify the measured 12-lead ECG data based on characteristics of the individual population; Using the preprocessed measured 12-lead ECG data to train a machine learning model; determining, by the processing device, the remaining V leads based on Lead I, Lead II, Lead III, and Lead V using the machine learning model; and Lead I, Lead II, Lead III, and Leads aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 are provided for display on a client device.

14. The non-transitory computer-readable storage medium of claim 13, wherein: Lead II is determined simultaneously with Lead I.

15. The non-transitory computer-readable storage medium of claim 13, wherein: The V lead is at least one of lead V2 and lead V5.

16. A computer program product comprising instructions which, when executed by a processing device, cause the processing device to perform the method according to any one of claims 7 to 12.

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