12-lead electrocardiogram using three-electrode device

Abstract

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

Description

[0001] (This application is a divisional application of the application with the application date of December 10, 2020, the application number of 2020800959356, and the invention title of “12-lead electrocardiogram using a three-electrode device.”) TECHNICAL FIELD

[0002] 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 with a computing device such as a personal computer, laptop computer, tablet computer, smart phone, or wearable computing device. BACKGROUND

[0003] Cardiovascular disease is the leading cause of death in the world. 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 each year from cardiovascular disease. Cardiovascular disease is prevalent among populations in both high- and low-income countries.

[0004] Arrhythmia is a heart condition in which the electrical activity of the heart is irregular or faster (tachycardia) or slower (bradycardia) than normal. While many arrhythmias are not life-threatening, some can lead to cardiac arrest and even sudden cardiac death. In fact, arrhythmia is one of the most common causes of death when people go to the hospital. SUMMARY

[0005] The present invention relates to an apparatus comprising: an electrocardiogram device having a first electrode assembly, a second electrode assembly, and a third electrode assembly, the first electrode assembly, the second electrode assembly, and the third electrode assembly 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; and a processing device for: determining a lead I from the first electrical signal and the second electrical signal, determining a lead II from the second electrical signal and the third electrical signal, generating a lead III using (lead III = lead II - lead I), determining leads aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 based on lead I, lead II, and lead III using a machine learning model trained with measured 12-lead ECG data, and providing the leads, i.e., lead I, lead II, lead III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6, for display on a client device. BRIEF DESCRIPTION OF DRAWINGS

[0006] The novel features of the application are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present application will be obtained by reference to the following detailed description that sets forth illustrative

[0007] Figure 1 shows a schematic view of 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 smart phone and a protective smart phone case according to 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 case according to many embodiments;

[0010] Figures 4A to 4C shows a biometric or physiological parameter measurement and monitoring system including a keyboard of a computing device and a keyboard accessory 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 accessory according to many embodiments;

[0012] Figure 6 shows a method for biometric or physiological parameter measurement and monitoring according to many embodiments;

[0013] Figure 7 is a diagram of a body showing an example 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 (showing positioning of V6-V12);

[0015] Figure 9A shows a front view of one variation of the apparatus as described herein (where in this example a wireless mobile telecommunications device is shown inserted into the apparatus configured as a case);

[0016] Figure 9B , Figure 9C and Figure 9D show left side, rear and right side views, respectively, of the apparatus of Figure 9A ;

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

[0018] Figures 10B to 10D left, rear and right side views of the device of Figure 4A

[0019] Figures 11A to 11C another variation of the device as described herein is illustrated from left, rear and right side views (in this example, the leg (first) electrode is on the edge between the rear surface and the left side of the housing);

[0020] Figures 12A to 12C another variation of the device as described herein is illustrated from left, rear and right side views (in this example, the leg (first) electrode is on the edge between the rear surface and the left side of the housing);

[0021] Figures 13A to 13C another variation of the device as described herein is illustrated from left, rear and right side views (in this example, the leg (first) electrode is on the edge between the rear surface and the left side of the housing);

[0022] Figures 14A to 14C another variation of the device as described herein is illustrated from left, rear and right side views (in this example, the leg (first) electrode is on the edge between the rear surface and the left side of the housing);

[0023] Figures 15A to 15C another variation of the device as described herein is illustrated from left, rear and right side views (in this example, the leg (first) electrode is on the edge between the rear surface and the left side of the housing);

[0024] Figures 16A to 16B another variation of the device as described herein is illustrated from left, rear and right side views (in this example, the leg (first) electrode is on the edge between the rear surface and the left side of the housing);

[0025] Figure 17 application of one variation of the device for detecting ECGs as described herein is illustrated, held against the leg of a patient so that the leg electrode contacts the leg while the patient's hands are in contact with the left and right electrodes on the back of the device, respectively;

[0026] Figure 18 is an illustration of the human hearing range and thresholds from http: / / en.labs.wikimedia.org / wiki / Acoustics;

[0027] Figure 19 ​is a graph of hearing loss with age 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 of a system configured to ultrasonically transmit digital data encoding one or more biological parameters to a telecommunication device such as a smart phone;

[0030] Figure 21B is a schematic 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 smart phone;

[0031] Figure 21C is a schematic of a system including a medical sensing device configured to ultrasonically transmit and receive data encoding one or more biological parameters (e.g., ECG data) to a telecommunication device such as a smart phone;

[0032] Figure 22 shows one variation of a digital signal that has been frequency key shift encoded 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 shows one example of a flow chart of a demodulator and packet decoder used by a receiver configured to receive and decode data transmitted ultrasonically as discussed herein;

[0036] Figure 26A shows one exemplary format of a hybrid digital and analog ultrasound data format;

[0037] Figure 26B shows another exemplary format of a hybrid digital and analog ultrasound data format;

[0038] Figure 27This is a schematic diagram of a system for secure ultrasonic transmission of data. The system includes an ultrasonic communication device with an ultrasonic transducer and an encryption key located on the ultrasonic communication device for 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 An example of a variation of a wristband device for sensing one or more biometric parameters and for wirelessly transmitting those biometric parameters to a mobile communication / computing device at extremely low power is given. Figure 28A The image shows the appearance of the wristband, while Figure 28B The illustration includes a schematic diagram of the internal areas of various modules used for sensing, powering, and transmitting ultrasonic signals, and many of these components are optional.

[0040] Figure 29 A variation of a wristband for a watch configured to detect ECG signals is shown.

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

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

[0043] Figure 32 This is a flowchart of a method for machine learning training of a 12-lead ECG using a three-electrode device, according to some embodiments of the present invention. Detailed Implementation

[0044] Apparatus, systems, and methods for measuring and monitoring biometrics or physiological parameters in a user-friendly and convenient manner are disclosed.

[0045] It should be understood that the invention is not limited in its application to the details of the construction, experiments, exemplary data, and / or arrangement of components set forth in the following description. The invention can have other embodiments or can be practiced or performed in various ways. Furthermore, it should be understood that the terminology used herein is for descriptive purposes and should not be considered limiting.

[0046] In the following detailed description of embodiments of the invention, numerous specific details are set forth to provide a more thorough understanding of the invention. However, it will be apparent to those skilled in the art that the concepts within the invention can 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 cardiac arrhythmia. In A-fib, electrical conduction through the heart's ventricles is irregular and disorganized. Although A-fib can not cause symptoms, A-fib is often associated with palpitations, shortness of breath, syncope, chest pain, or congestive heart failure, and also increases the risk of stroke. A-fib is typically diagnosed by capturing an electrocardiogram (ECG) of a subject. To treat A-fib, a patient can take medication to slow the heart rate or change the rhythm of the heart. A patient can also take an anticoagulant to prevent stroke, or can even undergo surgical intervention including cardiac ablation to treat A-fib.

[0048] Generally, patients with cardiac arrhythmias or A-fib are monitored for long periods of time to manage the disease. For example, a patient can be provided with a Holter monitor or other ambulatory 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. An electrocardiogram (ECG) can be recorded or captured using electrodes placed on the patient's skin at multiple locations. The electrical signals recorded between pairs of electrodes are referred to as 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 lead sets 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, the arm and leg electrodes can be placed closer to the chest or closer to the end of the arm / leg. Variations in placement of the electrodes on the arms and legs can affect the ECG and make it more difficult to compare to a standard ECG.

[0051] A standard or conventional 12-lead ECG configuration uses 10 electrodes. Figure 1 An illustration of the 10 electrodes is shown, with six electrodes on the patient's chest and one electrode on each of the patient's arms and legs. The electrode placed on the right arm 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 electrodes 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, three electrodes can be used (e.g., with a device including three electrodes) to generate a 12-lead ECG. For example, in one embodiment, a device as described herein having three electrodes can be used to determine lead I (e.g., voltage between the left arm and the right arm) simultaneously with lead II (e.g., 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. In other embodiments, any other combination of leads is possible. The processing logic can then use lead I or another lead common to both sets of recordings to time align the two sets of recordings so that the two sets of measurements can be compared over the same analog time period.

[0053] The processing logic can further transform the two sets of leads to generate a full 12-lead ECG. In one embodiment, the processing logic can use a machine learning model (e.g., neural network, deep learning techniques, etc.) to make this transformation. The machine learning model can be trained using 12-lead ECG data corresponding to a population of individuals. This data can 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 can be categorized according to height, gender, weight, nationality, etc. before being used to train one or more machine learning models, such that the one or more models so derived are fine-tuned for a particular 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 and individualize the model to reduce any residual aggregate error.

[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 An example placement of six electrodes on the chest (labeled VI, V2, V3, V4, V5, and V6) is shown. VI 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, level with V4. V6 is placed horizontally in the midaxillary line, level 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 Central Terminal (WCT or VW) can be calculated as (RA + LA + LL) / 3. Given that leads I and II are both recorded with respect to RA, such that the voltage of RA can be considered to be zero, WCT (VW) can be calculated as lead I + lead II / 3.

[0057] A pressor limb lead can also be determined from RA, RL, LL, and LA. Pressor vector right (aVR) is equal to RA - (LA + LL) / 2 or -(I + II) / 2. Pressor vector left (aVL) is equal to LA - (RA + LL) / 2 or I - II / 2. Pressor 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. Improper or offset electrode placement can offset the results of an ECG on the six-axis system.

[0059] However, current ambulatory electrocardiography devices, such as Holter monitors, are typically bulky and difficult for a subject to apply without the assistance of a medical professional. For example, the use of a Holter monitor requires a patient to wear a bulky device on their chest and precisely place multiple electrodes on precise locations on their chest. These requirements can impede the activities of the subject, including their natural movements, bathing, and showering. Once a fully disclosed ECG is generated, it is sent to the patient's physician, who then analyzes the ECG and provides a diagnosis and other recommendations. Currently, this process must typically be administered through a hospital administrator and health management organization, and many patients do not have convenient access to feedback.

[0060] Many handheld ECG measurement devices are known, including devices that can adapt existing mobile telecommunication 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 the housing that are 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., often must communicate wirelessly with a monitoring, analysis or recording station ("monitoring station"). Typically, the transfer of information has been by short wavelength radio transfer (e.g., "Bluetooth"). Notably, while some embodiments are described with respect to ultrasonic communication, it is contemplated that Bluetooth communication is equally, if not more, suitable for the described technology, and ultrasonic is presented only as a non-limiting example of any number of other suitable communication technologies. It is expected that one of reasonable skill in the art will recognize this.

[0062] In some situations where it is desirable for the device to be light in weight so that it can be comfortably worn during normal daily activities or exercise, many producers have opted to record data rather than transfer data, and to download the data periodically by direct connection to a monitoring station. It would be advantageous to provide a monitoring device that can be worn on the wrist (e.g., a wristband) or other body area by a subject that is capable of reliably and low-energy wireless transfer of data.

[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 a wristwatch-sized wearable monitor that can detect ECG signals from a patient wearing the device; these signals can be displayed on the device. The signals are not transferred. Other similar devices are described in U.S. Patent No. 4,938,228. US 5,351,695, US 5,333,616, US 5,317,269, and US 5,289,824 (all to Mils) describe improvements to the device that include an integral hearing-aid-type speaker for transferring ECG signals over a telephone line using the voice channel of the telephone using audible sounds (e.g., between 1 kHz and 3 kHz). The ECG signals are typically digitized and frequency modulated (e.g., as a frequency-shift keying signal). Unfortunately, such devices do produce audible signals that are noisy, require substantial power to generate and transfer, and cannot conduct two-way communication, particularly with mobile telecommunication devices.

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

[0065] Ultrasonic transmission has many similarities to electrical transmission, but also substantial differences, including differences that were previously considered to be disadvantages. Moreover, while techniques such as frequency shift keying for digitizing information are known, implementing such techniques on the time scale of making such techniques practical for medical (e.g., ECG) monitoring is difficult and impractical. In particular, transmission of ultrasonic data has been limited to some degree in terms of information content. For example, digital encoding of information by ultrasound is limited in terms of the amount and content of information transmitted. There are no standards for transmission or encoding for ultrasonic transmission. Moreover, such ultrasonic signals are not conventionally encrypted.

[0066] Accordingly, it would be advantageous to provide systems, devices, and methods for encoding or arranging information transmitted by 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 with one or more receiving devices using ultrasonic transmission.

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

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

[0069] Accordingly, there is a need for improved cardiac disease and / or rhythm management and monitoring devices, systems, and methods to address one or more of the above challenges.

[0070] Devices, systems, and methods for measuring and monitoring a biometric or physiological parameter in a user-friendly and convenient manner are disclosed. In particular, a relevant physiological parameter of a user can be measured while the user is normally operating a computing device or other manually operated or handheld device. For example, a 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, a tablet computer, or a smartphone. The one or more physiological parameters can be measured using an accessory for the computing device, such as a laptop shell, a tablet shell, or a smartphone shell. 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 a book or text reader. The physiological parameter monitoring and measurement applications 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 can include a device configured to be coupled to a computing device and a first application loaded onto the computing device. The device can include a sensor for measuring a cardiac parameter. The first application can be configured to receive the measured cardiac parameter from the sensor. The sensor can measure the cardiac parameter and the first application can receive the measured cardiac parameter while a second application is loaded onto the computing device and manipulated by the user.

[0072] The cardiac parameters can 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 can include one or more of a personal computer, a laptop computer, a tablet computer, a personal digital assistant (PDA), a smart phone, and a wearable computing device. In many embodiments, the computing device includes a tablet computer or a smart phone. The apparatus can be configured to be removably coupled to the computing device, and can include a cover for covering the computing device, such as a tablet cover or a smart phone cover or case, etc.

[0074] The sensor for measuring the cardiac parameters can include a first electrode and a second electrode configured to generate a signal including the cardiac parameters when in contact with the user. For example, the first electrode can be configured to contact the right arm of the user, and the second electrode can be configured to contact the left arm of the user to generate a Lead I ECG. Alternatively or in combination, the first electrode can be configured to contact the right arm of the user, and the second electrode can be configured to contact the left leg of the user to generate a Lead II ECG. Alternatively or in combination, the first electrode can be configured to contact the left arm of the user, and the second electrode can be configured to contact the left leg of the user to generate a Lead III ECG. The sensor can further include a third electrode for contact configured to generate a signal including the cardiac parameters when in contact with the user. The first electrode, the second electrode, and the third electrode may, for example, be used simultaneously to generate one or more of a Lead I ECG, a Lead II ECG, and a Lead III ECG. The first electrode can be configured to contact the right arm of the user, the second electrode can be configured to contact the left arm of the user, and the third electrode can be configured to contact the left leg of the user.

[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 the cardiac or other physiological parameter data and allow medical specialists and other professionals to access the data for data analysis, interpretation, and / or diagnosis. The analysis and diagnosis can be transmitted back to the user through the remote computing device and the user's computing device or through other channels, such as email, text message, or other electronic alerts. Alternatively or in combination, one or more of the first application loaded onto the computing device, another application loaded onto the remote server, and another application used by a medical specialist or professional can automatically generate such data analysis, interpretation, and / or diagnosis.

[0076] 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 inputting data into the second application, etc. By allowing the 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, the user can hold and normally operate the computing device to check email, web browse, or operate a mobile application while the first application and the computing device case measure and / or monitor the user's ECG or other cardiac and physiological parameters in the background.

[0077] Aspects of the present invention also provide a method of measuring a cardiac parameter of a user. A device including a sensor for a cardiac parameter can be coupled to a computing device. The cardiac parameter of the user can be measured with the sensor. The measured cardiac parameter can be transmitted to a first application loaded on the computing device with the device. The cardiac parameter can be measured and the first application can receive the transmitted measured cardiac parameter while the user manipulates a second application loaded on the computing device.

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

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

[0080] The cardiac parameter can be measured with the sensor by measuring the cardiac parameter with a first electrode and a second electrode of the sensor. The first electrode and the second electrode 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 right arm of the user and the second electrode can be configured to contact the left arm of the user to generate a lead I ECG. Alternatively or in combination, the first electrode can be configured to contact the right arm of the user and the second electrode can be configured to contact the left leg of the user to generate a lead II ECG. Alternatively or in combination, the first electrode can be configured to contact the left arm of the user and the second electrode can be configured to contact the left leg of the user to generate a lead III ECG. The cardiac parameter can also be measured with a third electrode of the sensor configured to generate a signal including the cardiac parameter when in contact with the user. The first electrode, the second electrode, and the third electrode can be used to generate one or more of a lead I ECG, a lead II ECG, and a lead III ECG, for example, simultaneously. The first electrode can be configured to contact the right arm of the user, the second electrode can be configured to contact the left arm of the user, and the third electrode can be configured to contact the left leg of the user.

[0081] Further, the received measured cardiac parameter can be displayed on / with a display of the computing device. The cardiac parameter can be displayed in real-time. Further, the measured cardiac parameter can be stored in a memory of the computing device. The measured cardiac parameter 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 specialists and other professionals to access the data for data analysis, interpretation, and / or diagnosis. The analysis and diagnosis can be transmitted back to the user through the remote computing device and the user's computing device or through other channels such as email, text messaging, or other electronic alerts. Alternatively or in combination, one or more of a first application loaded onto the computing device, another application loaded onto the remote server, and another application used by a medical specialist or professional can automatically generate such data analysis, interpretation, and / or diagnosis.

[0082] 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 inputting data into the second application, among others. By allowing a user to manipulate a second application loaded on a computing device while the first application measures and monitors the user's heart and other health parameter(s), embodiments of the present invention allow for user-friendly, convenient, and less invasive and disruptive measurement and monitoring of heart and other health parameters. For example, a user can hold and normally operate a computing device to check email, a web browser, or operate a mobile application while the first application and health parameter sensors are measuring and / or monitoring the user's ECG or other heart and physiological parameters in the background. In some embodiments, the first application can cause the computing device to alert the user (i.e., a pop-up window can be shown in the second application) if the health parameter sensors are positioned incorrectly such that proper measurements cannot be made.

[0083] Aspects of the present invention also provide a system for measuring a heart parameter of a user. The system can include a case configured to be removably attached to a portable computing device. The portable computing device can include a front side, a back side, and an edge between the two. The case can include a plurality of sensor electrodes configured for measuring a heart parameter and arranged on the edge of the portable computing device when the case 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 can include a laptop computer, a tablet computer, a personal digital assistant (PDA), or a smart phone.

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

[0085] The plurality of sensor electrodes can include a first sensor electrode and a second sensor electrode. The first and second sensor electrodes can be configured to generate signals including cardiac parameters when in contact with a first and second limb of the user, respectively. For example, the first electrode can be configured to contact the right arm of the user and the second electrode can be configured to contact the left arm of the user to generate a Lead I ECG. Alternatively or in combination, the first electrode can be configured to contact the right arm of the user and the second electrode can be configured to contact the left leg of the user to generate a Lead II ECG. Alternatively or in combination, the first electrode can be configured to contact the left arm of the user and the second electrode can be configured to contact the left leg of the user to generate a Lead III ECG. The plurality of sensor electrodes can also include a third sensor electrode configured to generate signals including cardiac parameters when in contact with a third limb of the user. The third electrode of the sensor can also be utilized to measure cardiac parameters, the third electrode configured to generate signals including cardiac parameters when in contact with the user. The first, second, and third electrodes may, for example, be utilized simultaneously to generate one or more of a Lead I ECG, a Lead II ECG, and a Lead III ECG.

[0086] The system can also include a first application loaded onto the portable computing device. The first application can be configured to receive measured cardiac parameters from the plurality of sensor electrodes. The first application can receive measured cardiac parameters while the second application is loaded onto the portable 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 inputting data into the second application, among others. By allowing a user to manipulate a second application loaded on a computing device while the first application measures and monitors cardiac and other health parameters of the user, 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 normally operate a computing device to check email, a web browser, or operate a mobile application while the first application and computing device measures and / or monitors ECG or other cardiac and physiological parameters of the user 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 the cardiac or other physiological parameter data and allow medical specialists and other professionals to access the data for data analysis, interpretation, and / or diagnosis. The analysis and diagnosis can be transmitted back to the user through the remote computing device and the user's computing device or through other channels such as email, text messaging, or other electronic alerts. Alternatively or in combination, one or more of the first application loaded onto the computing device, another application loaded onto the remote server, and another application used by a medical specialist or professional can automatically generate such data analysis, interpretation, and / or diagnosis.

[0088] Aspects of the present disclosure also provide a method for measuring a cardiac parameter of a user. A cover can be removably attached to a portable computing device. The portable computing device can include a front side, a back side, and an edge between the two. First and second electrodes of the cover can contact first and second limbs of the user, respectively, to generate a signal including the cardiac parameter. The first and second electrodes of the cover can be disposed on the edge of the portable computing device. In many embodiments, a plurality of sensor electrodes can be disposed only on the 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 smart phone.

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

[0090] The third electrode can contact a third limb of the user to generate a signal comprising a cardiac parameter. The first limb can comprise a right arm, the second limb can comprise a left arm, and the third limb can comprise a left leg. The three limbs can be simultaneously contacted by 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 can be used to generate lead I ECG, lead II ECG, lead III ECG. For example, the first electrode can be configured to contact a right arm of the user, and the second electrode can be configured to contact a left arm of the user to generate lead I ECG. Alternatively or in combination, the first electrode can be configured to contact a right arm of the user, and the second electrode can be configured to contact a left leg of the user to generate lead II ECG. Alternatively or in combination, the first electrode can be configured to contact a left arm of the user, and the second electrode can be configured to contact a left leg of the user to generate lead III ECG.

[0091] Alternatively or in combination, the first application can be loaded onto a tablet computer or a smartphone. The first application can be configured to receive measured cardiac parameters from the plurality of sensor electrodes. The first application can receive measured cardiac parameters while the second application is loaded onto the computing device and manipulated by the user. Manipulation of the second application can comprise 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 inputting data into the second application, etc. By allowing a user to manipulate a second application loaded on a 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 normally operate a computing device to check email, a web browser, or operate a mobile application while the first application and computing device measure and / or monitor 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 the first application. The received cardiac parameters can be displayed in real time. The measured cardiac parameters can be stored in a memory of the 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 the cardiac or other physiological parameter data and allow medical specialists and other professionals to access the data for data analysis, interpretation, and / or diagnosis. The analysis and diagnosis can be transmitted back to the user through the remote computing device and the user's computing device or through other channels such as email, text messaging, or other electronic alerts. Alternatively or in combination, one or more of the first application loaded onto the computing device, another application loaded onto the remote server, and another application used by a medical specialist or professional can automatically generate such data analysis, interpretation, and / or diagnosis.

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

[0094] The invention also describes devices (including systems, software, and apparatuses) and methods (including methods for using the devices) for capturing electrocardiogram (ECG) information from a subject using an interface compatible with a mobile telecommunications device having three electrodes. Devices for detecting ECGs are 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 apparatuses and systems) and methods described herein are used to detect biological signals such as electrocardiograms (ECGs). In particular, devices are described herein for use with a mobile telecommunications device so that the mobile telecommunications device can receive biological signals measured directly from a patient. The devices generally include three or more electrodes (or exactly three electrodes) for receiving signals such as voltage or current from the patient's body. The devices can also include a housing. The housing can be configured to hold or be directly connected to a mobile telecommunications device such as a "jacket" or the like. One or more electrodes can be positioned directly on an outer surface of the housing. The devices can also include one or more transmitters for communicating sensed signals (including modified / processed versions of the sensed signals) from the electrodes to the mobile telecommunications device. The mobile telecommunications device can be connected to the housing, e.g., within or near a jacket formed by the housing. In some variations, the devices can include one or more processing devices for processing signals detected on the electrodes.

[0096] Any appropriate transmitter (including a wireless transmitter) can be used. In some variations, the wireless transmitter is an ultrasonic transmitter that can use inaudible ultrasound (e.g., >10 kHz, >12 kHz, >15 kHz, >18 kHz, >19 kHz) that can be received by a microphone on the mobile telecommunications device and transmitted and / or further processed by the mobile telecommunications 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 by reference herein in its entirety).

[0097] The devices described herein can be configured so that they can be held by a patient with both hands against a leg (e.g., left leg or right leg) of the patient to measure six "leads" (leads I-III and augmented leads aVR, aVL, aVF) from the patient. In some variations, the devices can be configured so that the patient can easily see the screen of the mobile telecommunications device while holding the device (enclosing the mobile telecommunications device) against a leg (right or left) with both hands to record isolated signals from each of the right arm, left arm, and right or left leg. This would allow the patient to receive immediate visual feedback from the device while taking the measurement, including providing guidance (using the mobile telecommunications device screen or audio output) to adjust or correct the contact or position of the electrodes, and / or displaying one or more ECG signals. Thus, the devices can be configured as described herein so that they 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 view the screen of the mobile telecommunications device coupled to the device.

[0098] Generally, a patient (as used herein) can be a human or non-human patient, which includes but is not limited to an animal (dog, cat, horse, etc.). Thus, any device or method described herein can be used for veterinary purposes or configured as a veterinary product.

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

[0100] For example, electrocardiogram (ECG) monitoring devices for use with a wireless telecommunications device are described herein. In some variations, a device includes a housing configured to fit over a telecommunications device, the housing having an outer back surface, at least two outer side surfaces perpendicular to the back surface, and a front region through which a picture of the telecommunications device held in the housing can be viewed; a first electrode on or adjacent to one of the at least two outer side surfaces; a second electrode on the outer back surface, the second electrode having an outer contact surface; and a third electrode on the outer back surface, the third electrode having an outer contact surface, wherein the outer contact surfaces of the second and third electrodes are recessed relative to at least a portion of the outer back surface such that the outer contact surfaces of the second and third electrodes do not contact a work surface when the housing is placed on the work surface with the outer back surface facing 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 the left hand and the outer contact surface of the third electrode with only the right hand while holding the first electrode against a leg, and can view the picture of the telecommunications device held in the housing.

[0101] When the device is configured as a case, the case can be configured to hold a mobile telecommunication device within a cavity, or otherwise apply over a mobile telecommunication device. Thus, the case can include one or more interior surfaces for holding a mobile telecommunication device, and can have a front region through which a picture and / or any controls of the mobile telecommunication device can be seen and / or manipulated. For example, the case can include a cut-out region or a transparent cover through which the mobile telecommunication device can be seen. The electrodes can be mounted on the case. The case can also include one or more other openings for access to controls, inputs, outputs, or connection regions (e.g., jacks, plug-in sockets, etc.) of the mobile telecommunication device. Typically, the electrodes are arranged on the case so that: (1) when the device is not in use, the electrodes are protected from contact with surfaces, particularly metal surfaces; and (2) the electrodes can be easily contacted by a patient holding the device against a leg, to simultaneously record from both arms (via hands) and a leg, while still easily viewing a picture. The case can also house additional components, such as a transmitter as described above, a power source (e.g., a battery, a solar power source, etc.), and / or a processing device or other circuitry for conditioning, amplifying, filtering, or otherwise modifying a signal(s) received by the electrodes, etc. In some variations, the device can be configured so that one of the electrodes (e.g., the second electrode or the third electrode) can act as a reference electrode for the other two (or, in some cases, more) electrodes.

[0102] In variations, the case can include one or more attachment regions for one or more electrodes. For example, the case can include an opening on the back for connection with an electrode unit that can be used with cases having different configurations (e.g., for fitting different sized mobile telecommunication devices). All three electrodes can be part of the same electrode unit, or multiple electrode units can be used. The electrode unit can include additional hardware such as the processing device mentioned, and can also include a power source or other electronic components.

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

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

[0105] The first electrode can be configured so that it is easily held against the leg of the patient while holding the housing and touching the second and third electrodes with the left and right hands, respectively. Thus, in some variations, the first electrode is entirely on a side surface of the housing (e.g., on one of the at least two outer side surfaces). Optionally, the first electrode can be on a rear surface of the housing, but extend along the edge so that it can be held against the leg when the edge of the housing is held against the leg. Thus, the first electrode can be on the rear surface but abut or immediately adjacent to a side surface (one of the at least two outer side surfaces). In some variations, the first electrode curves from the rear surface of the housing over the edge of the housing (e.g., along the edge of the housing) toward the side surface. Thus, the first electrode can extend over the edge between one of the outer side surfaces and the outer rear surface. Any of these configurations can allow the housing of the mobile telecommunication device to be held at an angle relative to the leg of the patient so that the patient can have good contact with the leg while still holding the housing in both hands, contacting the second and third electrodes, and viewing the screen of the mobile telecommunication device.

[0106] Thus, generally, the first electrode can extend along all or a portion (e.g., > half) of the length of a side of the housing. If the first electrode extends on or near the edge of the housing, and along all or a substantial portion (e.g., between about 100% and about 50%, between about 90% and about 60%, about 75%) of the edge of the housing, the housing can be easily held against the leg and contacted as described and illustrated 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 more than half the length of the outer side surface.

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

[0108] Generally, the device can be configured such that when the device is placed down on a work surface with the electrodes (first and / or second and third electrodes) facing the work surface, the electrodes do not contact the surface of the work surface. This permits the device to be placed down on a metal surface without creating a conductive path between the electrodes and thereby potentially discharging (and / or depleting power from the device), as is often found in hospital or other medical environments. In some variations, the electrodes are recessed relative to the outer back 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 on when the back surface is placed down, thereby preventing the one or more electrodes from contacting the surface. For example, the outer back surface of the housing can include one or more“spacers” configured to extend a portion of the outer back surface relative to the outer contact surface of the first and second surfaces, such that the outer contact surface is recessed relative to the outer surface of the one or more spacers. Generally, a spacer can refer to a protrusion from the back surface of the device that is taller than the height of the electrode(s) relative to the back surface. For example, the spacer can be a bump, island, strip, tab, pull tab, etc. that extends from the back surface (in some variations, around the electrode (e.g., entirely or partially encasing the electrode)).

[0109] Generally, the electrodes can have sufficient surface area to readily and reliably contact a 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 area of the three electrodes is approximately the same. In some variations, the surface area of the second or third (reference) electrode is larger than the other electrodes.

[0110] As noted above, any of the devices described herein can include a transmitter for communicating with a wireless telecommunication device. The transmitter can generally be wireless, or the transmitter can be directly connected (plugged into) the wireless telecommunication device. An electromagnetic transmitter (including a near-field transmitter, a radio frequency (RF) transmitter, etc.), an optical transmitter, or any other type of transmitter can be used. In particular, an ultrasonic transmitter that can be integrated into the device is described herein.

[0111] For example, described herein is an electrocardiogram (ECG) detection device for use with a wireless telecommunication device, the device comprising: a housing configured to fit over the telecommunication device, the housing having an outer back surface, at least two outer side surfaces perpendicular to the back surface, and a front region through which a picture of the telecommunication 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 back surface, the second electrode having an outer contact surface; a third electrode on the outer back surface, the third electrode having an outer contact surface; and an ultrasonic transmitter configured to transmit signals sensed from the first electrode, the second electrode, and the third electrode to the wireless telecommunication device using ultrasonic waves, wherein the outer contact surfaces of the second electrode and the third electrode are recessed relative to at least a portion of the outer back surface such that when the housing is placed on a table surface with the outer back surface facing the table surface, the outer contact surfaces of the second electrode and the third electrode do not contact the table 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 a 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 of the ECG (Lead I) between the third electrode and the second electrode; detecting a second lead signal of the ECG (Lead II) between the second electrode and the first electrode; and detecting a third lead signal of the ECG (Lead III) between the first electrode and the third electrode.

[0113] Also described herein are methods 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 a 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 of the ECG (Lead I) between the third electrode and the second electrode; detecting a second lead signal of the ECG (Lead II) between the second electrode and the first electrode; and detecting a third lead signal of the ECG (Lead III) between the first electrode and the third electrode.

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

[0115] The second and third electrodes can be entirely on the outer back surface. The first electrode can be entirely located on one of the at least two outer side surfaces. The first electrode can be located on the outer back surface proximate to one of the at least two outer side surfaces. The first electrode can extend on an edge between one of the outer side surfaces and the outer back surface. The outer side surfaces can each be rectangular, and the first electrode can be centered between two short edges of one of the outer side surfaces and can extend longitudinally in a direction of a long edge of one of the outer side surfaces. The first electrode can extend on or adjacent to one of the outer side surfaces more than half the length of the outer side surface. The second and third electrodes can be positioned symmetrically relative to each other relative to a center of the outer back surface. The second and third electrodes can be portions of electrode units that fit within openings in the outer back surface of the housing. The first electrode can have a surface area that is approximately the same as a surface area of the second or third electrode.

[0116] The device can include only three electrodes on an outer surface of the housing. The outer back surface of the housing can include one or more spacers configured to extend a portion of the outer back surface relative to the outer contact surfaces of the first and second surfaces such that the outer contact surfaces are recessed relative to an outer surface of the one or more spacers.

[0117] The device can further include an ultrasonic transmitter configured to transmit signals sensed from the first, second, and third electrodes to the wireless telecommunication device using ultrasonic waves.

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

[0119] Aspects of the invention also provide 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 patient can be instructed to hold a first electrode extending along a side of the housing against a leg while touching a second electrode on a 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. 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 invention also provide 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 patient can be instructed to hold a first electrode extending along a side of the housing against a leg while touching a second electrode on a 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. 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 wirelessly (e.g., with ultrasound) transmitted from the housing to the telecommunication device.

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

[0122] Generally, described herein are devices, systems, and methods for transmitting digital and / or analog data from (and in some cases to) a wearable (e.g., wristband) device with one or more sensors, a microprocessor, and a transducer capable of delivering ultrasound frequencies (i.e., a piezoelectric speaker). The digitally transmitted data can be received by a receiving device (such as a telecommunications device (e.g., a phone such as an iPhone, DROID, or other smart phone, an iPad or other personal computer, or a PDA, etc.) with a microphone capable of receiving audio in the ultrasound 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 greater 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 (e.g., from wristband to device) and two-way communication are contemplated, including various methods for simple two-way communication between a wearable device and a monitoring station (e.g., a smart phone).

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

[0125] Described herein are wristband devices that include 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 ultrasound modem. In some variations, the microcontroller includes logic (e.g., hardware, software, firmware, or some combination thereof) that licenses the device to drive ultrasound transmission of data from a speaker (e.g., a piezoelectric speaker element). Also described are methods of configuring or adapting a microcontroller to operate as an ultrasound modem. For example, in some variations, the microcontroller can be programmed to operate as an ultrasound modem. The ultrasound modem can be configured to format information to be transmitted in a hybrid digital and analog format. In some variations, the ultrasound modem can be an ultrasound modem component that encrypts information using an encryption key.

[0126] Also described herein are receivers configured to receive ultrasonic digital data acoustically transmitted by an ultrasonic digital modem. Generally, a telecommunications device (e.g., a smartphone) can be configured to act as a receiver to receive ultrasonic digital data. Accordingly, the telecommunications device can include hardware, software, and / or firmware configured to receive, decode, interpret, display, analyze, store, and / or transmit data transmitted from a digital ultrasonic modem over ultrasound. In some variations, logic (e.g., client software and / or firmware, applications, etc.) can be executed on the telecommunications device such that the logic can act as a receiver of digital ultrasonic data. Accordingly, described herein are executable logic for receiving and interpreting (e.g., decoding) data transmitted by a digital ultrasonic modem, as well as devices including executable logic for receiving and interpreting (e.g., decoding) data transmitted by a digital ultrasonic modem.

[0127] Further described herein are particular devices and systems configured to include a digital ultrasonic modem. Any of these devices can 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 loudspeaker capable of emitting ultrasonic signals), and a controller (e.g., a microcontroller) configured to encode digital information from the digital information source into ultrasonic signals to be transmitted by the acoustic transducer. In some variations, the acoustic transducer is configured to emit audible (e.g., sub-ultrasonic) sounds (buzzer and beeping sounds in the normal human audible range, etc.) as well as at ultrasonic frequencies (e.g., greater than 17 kHz).

[0128] In examples described herein, a Texas Instrument AFE4110 digital thermometer has been modified as described to encode temperature data and transmit over ultrasound to a telecommunications device (e.g., a smartphone) located a distance from the thermometer. The microcontroller of the device (a MSP430-type controller from Texas Instrument) has been configured to include an ultrasonic modem for transmitting ultrasonic digital data by encoding a data signal (via the microprocessor) for transmission on a connected piezoelectric loudspeaker. The loudspeaker can be the same loudspeaker that is pre-set in the thermometer and used to audibly (e.g., with the normal human audible range) notify a user of a stable temperature. Accordingly, the 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 on the piezoelectric loudspeaker in the ultrasonic frequency range (e.g., > 17 kHz). The thermometer can include a security key (e.g., a barcode, a QR code, etc.) printed on the outside 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 biological parameter information received by the medical sensing devices to one or more telecommunication devices (e.g., a smart phone), where the information can be further processed on the telecommunication device and / or can be transmitted on the telecommunication device. The executable logic can also be referred to as an adapter for adapting the medical sensing device so that the medical sensing device can transmit biological parameter information to the telecommunication device using ultrasound 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 ultrasound encoded health metric information signals. These subsystems can include client software (e.g., an application) to be run on the telecommunication device (e.g., a phone) to translate the ultrasound health information (or biological parameter) signals into digital signals that can be uploaded, stored, and / or analyzed by the telecommunication device.

[0130] The medical sensing device can be any device for receiving a biological parameter, such as a patient vital sign, etc. The biological parameter can also be referred to as biometric data. For example, the 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 in that they can display a numerical (e.g., digital) representation of the biological parameter. For example, these devices can convert an analog biological parameter (e.g., temperature, blood sugar, blood pressure, or any other health metric information) into a digital signal that can be displayed or otherwise presented to a user. For example, the medical sensing system can include a digital thermometer for capturing a temperature of a subject, 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 especially those with sensors that monitor or collect biological parameters from a patient and present information on a display.

[0131] As described in more detail below, in some variations, the devices and systems format and / or encode information so that the information includes a mix of both 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 a change or trend. Analog information can refer to a variable physical level that is quantified (e.g., a variable that changes over time). The 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 a change in one or more parameters over time, distance, or some other change.

[0132] Any information that is transmitted as an ultrasonic signal (e.g., analog, digital, hybrid digital / analog, etc.) can be encrypted. For example, the information can be encrypted using an encryption key. The encryption key can be displayed on or can otherwise be utilized by the device that transmits the ultrasonic signal. Typically, the encryption key can be entered into a telecommunications device such that that particular device is then paired with the device that includes the ultrasonic modem, and can receive and decrypt the information. Encryption of the data can allow for protection of patient sensitive information. Encryption can also reduce noise in the system as it can limit the received signal to only correctly encrypted signals.

[0133] As used herein, biological parameters or information can include any patient information processed, sensed, and / or calculated by the medical sensing system, particularly digitally encoded biological parameters. For example, biological parameters can include temperature, blood pressure, blood glucose level, pH, oxygenation, pulse rate, respiration rate, or any other biological measurement, particularly those parameters related to medical situations including diagnosis and health monitoring.

[0134] As used herein, a telecommunications device includes a smart phone (e.g., iPhone™, droid™ 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 sound. The telecommunications device can include logic for translating the digital signal encoded by the ultrasonic sound into a digital signal that can be displayed, uploaded / transmitted, stored, and / or analyzed.

[0135] Thus, in some variations, described herein are medical sensing devices for transmitting digital biological parameters with ultrasonic sound. In some variations, the device can include a sensor for detecting a biological parameter from a patient, a processing device for encoding a digital representation of the biological parameter as an ultrasonic sound signal, and an ultrasonic transducer for transmitting the ultrasonic sound signal from the processing device.

[0136] For example, the sensor can be a transducer for converting a biological parameter (temperature sensor, pressure sensor, etc.). The device can also include a controller (e.g., microcontroller) for processing signals from the sensor(s). The processing device can include a signal generator that generates a signal from the sensed and / or processed patient biological parameter information; the signal can be encoded for transmission. The signal can be encoded as a digital packet (e.g., word, byte, etc.). For example, the signal can include a start bit, a stop bit, an information bit(s) identifying the type or source of the biological parameter (e.g., packet identifier), a digital representation of the biological parameter, and in some variations, a cyclic redundancy check (CRC) portion. In some variations, the signal (including the biometric measurement or data portion) can have a time and / or date stamp.

[0137] As noted above, in some variations, the system can be configured to encrypt the information and transmit only the encrypted information; the telecommunication device can be configured to receive the encryption key directly (e.g., by capturing and / or analyzing a graph describing the encryption key).

[0138] In some variations, the system or device can be configured such that a measurement is taken at time x and stored on the device (e.g., thermometer, blood glucose meter, etc.) and transmitted to the telecommunication device (e.g., smart phone or tablet) with ultrasound at a 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 transmitted together to the telecommunication device in a burst. As described in more detail below, although in some variations the device can be primarily unidirectional (e.g., sending data from the biometric measurement device to the telecommunication device), the device can be configured to receive at least an acknowledgement signal and / or an indicator of the proximity of the telecommunication device. In some variations, the ultrasound transducer can also be configured to receive an acknowledgement signal from the telecommunication device. The acknowledgement can signify that the telecommunication device received the transmitted message (data) or that the telecommunication device is ready to receive the transmitted data, or both.

[0139] The ultrasound transducer can be any appropriate transducer (including a piezoelectric crystal transducer).

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

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

[0142] The client control logic can also be referred to as software (although it can be software, hardware, firmware, etc.) or a client application. The client control logic can be executed on the telecommunication device. The client control logic can also include components for communicating the digital representation of the bio-parameter to other devices, for example, uploading it to a website or server, for example. In some variations, the client control logic can be configured to display or otherwise present information locally on the telecommunication device.

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

[0144] As an example, described herein is a digital thermometer for communicating digital temperature information as ultrasound to a telecommunication device for further processing and communication. The digital thermometer can comprise: a temperature sensor for sensing a patient temperature; a signal generator for generating a signal corresponding to a digital representation of the patient temperature; and an ultrasound transducer for communicating the digital representation of the patient temperature as an ultrasound signal comprising one or more frequencies higher than 19 kHz. The thermometer can comprise an encryption key external to the thermometer, which can be imaged and / or observed by a user and / or the telecommunication device configured to receive the ultrasound signal.

[0145] In general, described herein is a digital ultrasound modem device for securely communicating digital data as ultrasound. Such a device can comprise: a microprocessor; an ultrasound transducer; an encryption key located on the device; and ultrasound communication logic configured to encrypt the digital data according to the encryption key, the ultrasound communication logic further configured to configure the digital data for acoustic communication by the ultrasound transducer at frequencies of 17 kHz or higher.

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

[0147] Any of the systems described herein can be configured as a system for secure ultrasonic transfer of data, and can include: an ultrasonic communication device including an ultrasonic transducer, an encryption key located on the ultrasonic communication device, and ultrasonic transfer logic configured to encrypt digital data according to the encryption key and to configure the digital data for acoustic transfer by the ultrasonic transducer at a frequency of 17 kHz or higher; and decryption logic executable on a telecommunication device, wherein the telecommunication 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 can be visible on the ultrasonic communication device or packaging of the device, etc.

[0149] In any of the variations described herein, the telecommunication device can include an input for inputting the encryption key, which can provide information to the decryption logic. For example, the input can be a camera for capturing an image of the encryption key (e.g., a barcode, QR code, etc.) and determining the encryption key from the image. In some variations, the input includes a manual input (e.g., a keyboard, touch screen, etc.) for manually inputting the encryption key.

[0150] Methods for securely transferring information using ultrasound are also described herein. 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 with the encryption key.

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

[0152] Typically, any of the systems described herein can use hybrid digital and analog encoding. For example, a device for transferring digital and analog ultrasonic data (hybrid digital and analog data) can include: a microprocessor; an ultrasonic transducer; and hybrid transfer logic configured to generate a signal including digital data appended to analog data for acoustic transfer by the ultrasonic transducer at a frequency of 17 kHz or higher.

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

[0154] In any of these variations, the device can include a sensor for detecting a biological parameter from the patient, and / or a microprocessor configured to extract digital data from the analog data. In some variations, the digital data includes calibration data (e.g., minimum, maximum, variable interval (e.g., time interval), scale, etc.) of the analog data. The analog data can include any appropriate signal typically measured from a device sensor, such as an EEG, temperature of the subject over time, glucose level of the subject over time, blood pressure of the subject over time, oxygen level of the subject over time, or physical activity of the subject over time, etc.

[0155] Methods of transmitting mixed digital and analog signals using ultrasound are also described herein. For example, a method can include generating an ultrasound signal including digitally encoded data encoded using frequency shift keying (FSK) appended to an analog signal including a frequency modulated signal modulated at a frequency above 17 kHz, and acoustically transmitting the signal using an ultrasonic transducer.

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

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

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

[0159] ECG sensing wristbands configured to transmit ECG information to a mobile telecommunication device or devices are also described herein.

[0160] For example, described herein are wireless wearable cuff devices for receiving electrocardiogram (ECG) signals from a subject wearing such a device and transmitting that information to a mobile telecommunications device using ultrasound. The cuff device can include a cuff body configured to fit around a wrist, two or more electrodes for detecting ECG signals from the subject, an ultrasound transducer, and a processing device coupled to the ultrasound transducer and configured to receive ECG signals from the two or more electrodes and encode those signals to be transmitted to a signal for transmission by the ultrasound transducer at a frequency above about 17 kHz.

[0161] The cuff body can be configured as a band (e.g., any type of watch band), a bracelet, or a bracelet, etc. In some variations, the cuff includes a “face” area that can be worn facing upwards on top of the subject’s wrist. The cuff can include a pair of electrodes (or more than two electrodes). For example, in some variations, the cuff includes an inner electrode that faces the wearer’s wrist when the cuff is worn, such that the cuff can be in reliable contact with the wearer’s skin when worn. A second electrode can be located on the face or side of the cuff; this second electrode can be configured to allow the wearer to touch the cuff with the other hand / arm. In some variations, a third electrode can be located on the cuff. For example, the third electrode can be present on the side of the cuff and configured such 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 to an ultrasound signal for transmission by the ultrasound 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 to a hybrid signal that includes digital information appended to an analog signal.

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

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

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

[0166] Generally, any wrist-worn device can be configured without a display or output, or with only an audible output (e.g., beeps, tones) or with an LED (e.g., simple indicator light). Instead, the device can rely on communication with a base station, such as a mobile telecommunication device, to display and in some cases analyze the signal. For example, the device can include an indicator that indicates when the device is in communication with a mobile telecommunication device. Thus, a wrist-worn device that does not include a display for displaying ECG information can make the device smaller, lighter, and cheaper to manufacture and operate.

[0167] Further, in some variations, the devices can 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 the variations in some variations can attach additional information, such as a time / date stamp, user input data, etc. Thus, in some variations, the device further includes 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 as a digital signal.

[0169] Generally, the device (e.g., the processing device) can also be configured to determine when a mobile telecommunication device receives the encoded signal from the device.

[0170] The wrist-worn devices described herein can also be configured as a timepiece and can include a watch face, etc.

[0171] Also described herein are wireless wearable wrist-worn devices to detect an electrocardiogram (ECG) signal from a subject wearing the device and transmit that information to a mobile telecommunication device using ultrasound, the wrist-worn device comprising: a wrist-worn body configured to fit around a wrist; two or more electrodes to detect an ECG signal from the subject; an ultrasound transducer; and a processing device coupled to the ultrasound transducer and configured to receive the ECG signal from the two or more electrodes and encode a signal to be transmitted as a hybrid ultrasound signal for transmission by the ultrasound transducer at a frequency higher than about 17 kHz, the hybrid ultrasound signal comprising digital information appended to an analog representation of the ECG signal.

[0172] As described herein, the mixed ultrasound signal can be configured to encode digital information with frequency shift keying (FSK) and to append the FSK digital signal to an analog signal that has not been encoded with FSK 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 as an ultrasound signal for transmission by the ultrasound transducer at any appropriate ultrasound 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 ultrasound signals. For example, the device can include an ultrasound receiver configured to receive ultrasound signals from the mobile telecommunication device. In some variations, the same transducer used to transmit ultrasound signals (e.g., ECG signals) can also be configured to receive ultrasound signals (e.g., ready to receive, request to transmit, confirmation of transmission, request to retransmit, etc.). The ultrasound transducer can be configured to transmit signals from the processing device as ultrasound signals and to receive ultrasound signals from the mobile telecommunication device.

[0174] Also described herein are wireless wearable cuff devices to detect electrocardiogram (ECG) signals from a subject wearing the device and transmit that information to a mobile telecommunication device using ultrasound waves. The cuff devices can include a cuff body configured to fit around a wrist, two or more electrodes to detect ECG signals from the subject, an ultrasound transducer configured to transmit and receive ultrasound signals, and a processing device coupled to the ultrasound transducer and configured to receive ECG signals from the two or more electrodes and encode a signal to be transmitted as an ultrasound signal for transmission by the ultrasound transducer at a frequency above about 17 kHz. Further, the processing device can be configured to receive ultrasound signals from the mobile telecommunication device.

[0175] Aspects of the present disclosure also provide a wireless wearable cuff device to detect electrocardiogram (ECG) signals from a subject wearing the device and transmit that information wirelessly (e.g., using ultrasound waves) to a mobile telecommunication device. The cuff device can include a cuff body configured to fit around a wrist, two or more electrodes to detect ECG signals from the subject, a wireless (e.g., ultrasound) transducer, and a processing device. The processing device can be coupled to the wireless transducer and can be configured to receive ECG signals from the two or more electrodes and encode a signal to be transmitted as a wireless signal (e.g., an ultrasound signal for transmission by the ultrasound transducer at a frequency above about 17 kHz).

[0176] 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. The processing device can be configured to encode the signal to be transmitted as a hybrid signal comprising digital information appended to an analog signal. The device can also include an ultrasonic receiver configured to receive ultrasonic signals from the mobile telecommunication device. The ultrasonic transducer can be configured to transmit signals from the processing device as ultrasonic signals and receive ultrasonic signals from the mobile telecommunication device.

[0177] The device can also include a battery having a voltage less than 1.8. The processing device can be configured to transmit the encoded ECG signal in real time. The device can also include a memory coupled to the processing device and configured to store the encoded signal for later transmission. The processing device can be configured to encode the signal to be transmitted as a digital signal. The device can also include an indicator that indicates when the device is in communication with the mobile telecommunication device. The processing device can also be configured to determine when the mobile telecommunication device receives the encoded signal from the device. The device can be configured as a timepiece.

[0178] Aspects of the present invention also provide a wireless wearable cuff device to detect electrocardiogram (ECG) signals from a subject wearing the device and transmit that information wirelessly (e.g., with ultrasound) to a mobile telecommunication device. The cuff device includes a cuff body configured to fit around a wrist, two or more electrodes to detect ECG signals from the subject, a wireless (e.g., ultrasonic) transducer, and a processing device. The processing device can be coupled to the wireless (e.g., ultrasonic) transducer and configured to receive ECG signals from the two or more electrodes and encode the signal to be transmitted as a hybrid wireless (e.g., ultrasonic) signal for transmission, the hybrid wireless signal comprising digital information appended to an analog representation of the ECG signal. The ultrasonic transducer can transmit the signal at a frequency higher than about 17 kHz.

[0179] The hybrid ultrasonic signal can be configured to encode the digital information with frequency shift keying (FSK) and append the FSK digital signal to an analog signal that has not been encoded with FSK but has been frequency modulated. The processing device can be configured to extract the digital information from the ECG signal. The digital information can include calibration data for the analog signal. 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. The ultrasonic receiver can be configured to receive ultrasonic signals from the mobile telecommunication device. The ultrasonic transducer can be configured to transmit signals from the processing device as ultrasonic signals and receive ultrasonic signals from the mobile telecommunication device.

[0180] The apparatus can also include a battery having a voltage less than 1.8V. The processing apparatus can be configured to transmit the encoded signal in real time. The apparatus can also include a memory coupled to the processing apparatus and configured to store the encoded signal for later transmission. The processing apparatus can be configured to encode the signal to be transmitted as a digital signal. The apparatus can also include an indicator that indicates when the apparatus is in communication with a mobile telecommunication device. The processing apparatus can also be configured to determine when the mobile telecommunication device receives the encoded signal from the apparatus. The apparatus can be configured as a timepiece.

[0181] Aspects of the application also provide a wireless wearable wristband apparatus to detect electrocardiogram (ECG) signals from a subject wearing the apparatus and to transmit that information wirelessly (e.g., with ultrasound) to a mobile telecommunication device. The wristband apparatus can include a wristband body configured to fit around a wrist, two or more electrodes to detect ECG signals from the subject, a wireless (e.g., ultrasonic) transducer configured to transmit and receive ultrasonic signals, and a processing apparatus coupled to the wireless (e.g., ultrasonic) transducer and configured to receive ECG signals from the two or more electrodes and encode a signal to be transmitted as a wireless (e.g., ultrasonic) signal for transmission by wireless (e.g., ultrasonic) transmission. The ultrasonic transducer can transmit signals at a frequency higher than about 17 kHz. The processing apparatus can be configured to receive ultrasonic signals from a mobile telecommunication device.

[0182] The wearable computing apparatus can also take the form of a wristband or armband. Aspects of the application also provide an external housing or cover for a wrist- or arm-worn computing apparatus. The external housing or cover can include two or more electrodes to detect ECG signals from a subject and a wireless transmitter to transmit the ECG signals to the wrist- or arm-worn computing apparatus.

[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. The system 1000 can include a computing device 1100 and an external sensor device 1200 for coupling or removably attaching to the computing device 1100. The computing device 1100 can include one or more of the following: a personal computer, a laptop computer, a tablet computer (such as an Apple iPad, Apple iPod, Google Nexus tablet, Samsung Galaxy tablet, Microsoft Surface, etc.), a personal digital assistant (PDA), a smart phone (such as an Apple iPhone, Google Nexus phone, Samsung Galaxy smart phone, etc.), and a wearable computing device (such as Google Glass, Samsung Galaxy Gear Smart Watch, etc.). In many embodiments, the computing device includes a tablet computer or a smart phone. The external sensor device 1200 can be configured to removably couple to the computing device 1100 and can include a cover for covering the computing device, such as a tablet computer housing or a smart phone housing or cover, etc. In this way, when the user US replaces or upgrades his or her computing device 1100, it can not be necessary 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 can have.

[0184] The computing device 1100 can 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 with, for example, a cellular data network (e.g., using GSM, GSM plus EDGE, CDMA, quad-band, or other cellular protocols) or a WiFi (e.g., 802.11 protocol) network, a local interface 1150, an operating system 1160 (which can 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 such as a first mobile software application ("mobile app") downloaded from an online application distribution platform, a second application 1180 such as a second mobile software application ("mobile app") downloaded from an online application distribution platform, and a user interface 1190. For example, the online application distribution platform can be the Apple App Store, Google Play, Windows Phone Store, or BlackBerry App World, among others. The operating system 1160 can include instructions for operating the computing device 1100. The user interface 1190 can 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 can be a touchscreen display for manipulating and controlling the operating system 1160, the first application 1170, or the second application 1180. One or more of these elements can be combined or omitted. The computing device 1100 can also include other components such as a motion detection component, one or more cameras, additional displays, a power supply, a fan, various I / O ports, etc.

[0185] The external device 1200 can include a sensor 1210, a processing device 1220, and a local interface 1230. The sensor 1210 is configured to couple with the user US through 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 a cardiac parameter of the user, such as a heart rate, a heart rate variability, a blood pressure, a blood pressure variability, an arrhythmia, a seismocardiogram (SCG), an SCG parameter, an electrocardiogram (ECG), or an ECG parameter, etc. Other physiological parameters are also contemplated. For example, the sensor 1210 can include an activity sensor, a blood glucose sensor, a blood oxygen sensor, a thermometer, a respiration sensor, a metabolic sensor, or an odor detector, etc. The processing device 1220 can receive and process the detected physiological parameters into signals for the local interface 1230 to send to the local interface 1150 of the computing device 1100 through a connection 1235. The connection 1235 can include a wired connection, such as a USB connection, a firewire connection, or a lightning connection, etc. Alternatively or in combination, the connection 1235 can include a wireless connection, such as a WiFi connection, a Bluetooth connection, a Bluetooth Low Energy 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, etc.

[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 executed using the processing device 1110 and the operating system 1160. The processing device 1110, under instructions from the first application 1170, can be coupled to the local interface 1150 of the computing device 1100 to receive the detected physiological parameter(s). In addition, the processing device 1110, under instructions from the first application 1170, 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. The processing device 1100, under instructions from the first application 1170, can also cause the physiological parameter to be displayed on the display 1195 of the user interface. For example, the physiological parameter can be displayed in real-time as it is measured. The first application 1170 can also include algorithms executed by the processing device 1110 to analyze the physiological data and can present the interpretation and analysis to the user US. For example, if an arrhythmia is detected, the processing device 1110, under instructions from the first application 1170, can alert the user US or even a remote healthcare provider (such as a doctor, nurse, or hospital, etc.) through the network interface 1140. In addition, the processing device, under instructions from the first application 1170, can 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, etc.) through 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 physiological parameter(s) to identify or authenticate the user and perform operations based on the identity of the user. For example, the user can be authenticated based on attributes of the user’s heartbeat. The duration of a particular portion of the user’s heart rhythm, the relative size of peaks of the user’s electrocardiogram (ECG), or other related amplitudes or amplitude ratios can be processed and compared to a stored profile to authenticate the user. The processing device 1110, under instructions from the first application 1170 or other applications, can be used to generate the baseline profile. In some embodiments, the processing device 1110, under instructions from the first application 1170 or other applications, can use the measured physiological parameter(s) to determine the mood of the user and provide related data.

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

[0189] The QRS-wave group can correspond to the depolarization of the ventricles, and can 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-wave group is larger than the P-wave. In addition, the Purkinje system of the heart (which can increase the conduction velocity to coordinate the depolarization of the ventricles) can cause the QRS-wave group to appear "spiky" rather than rounded. The duration of the QRS-wave group of a healthy heart can be in the range of 60 to 100 ms, but can vary due to conduction abnormalities. The duration of the QRS-wave group can be used as another source of heartbeat characteristics that are unique to the user.

[0190] The duration, amplitude, and morphology of each of the Q-wave, the R-wave, and the S-wave can vary among different individuals, and can vary significantly for users with heart disease or heart rate abnormalities. For example, a Q-wave that is greater than 1 / 3 the height of the R-wave or greater than 40 ms in duration can indicate a myocardial infarction and provide a unique characteristic of the user's heart. Similarly, other healthy ratios of the Q-wave and the R-wave can be used to distinguish the heartbeat of different users.

[0191] The electrical activity of the heart of the user US can 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 can include the PR interval and the 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-wave group. The PR interval can typically last 120 to 200 ms. PR intervals with different durations can indicate one or more defects in the heart, such as a first degree heart block (e.g., a PR interval that lasts more than 200 ms), a Wolff-Parkinson-White syndrome via an accessory pathway that causes early activation of the ventricles (e.g., a PR interval that lasts 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-wave group to the T-wave (e.g., starting at the junction between the QRS-wave group and the ST segment and ending at the start of the T-wave). The ST segment can typically last from 80 ms to 120 ms, and typically has a slight concave indentation. The 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 that is unique to the heartbeat of each user.

[0192] The T-wave can represent the repolarization or recovery of the ventricles. The interval from the beginning of the QRS complex to the peak of the T-wave can be referred to as the absolute refractory period. The last half of the T-wave can be referred to as the relative refractory period or vulnerable period. The amplitude of the T-wave, the duration of the absolute refractory period, and the relative refractory period can also be used to define 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 300 ms and 450 ms, and can vary based on the condition of the user's heart rate. Several correction factors have been developed to correct the QT interval 222 for heart rate. Both the measured QT interval value and the corrected QT interval value can be used to define unique characteristics of the user's heartbeat.

[0194] Since the heartbeat or heart rate of the user US can vary slightly based on the activity or emotion of the user US, each authorized user US can first provide a baseline or standard heart rate, heartbeat, or electrical activity to the device prior to first use. The first application 1170 can be run by the processing device 1110 to record this baseline reading. For example, the external device or sensor 1200 can sample several heartbeats or electrical activities at several different times to detect changes in the electrical activity of the heart of the user US. This data can be sent to the computing device 1100. The processing device 1110, under instructions from the first application 1170, can then process the detected signals to determine several unique characteristics of the heart activity of the user US, and identify ranges of suitable characteristic values for each of the processed characteristics. 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 heart activity profile for the authorized user US. The particular combination of characteristics and associated ranges can be selected to minimize overlap with other authorized users, or based on characteristic values and ranges that would not fall within the average values and ranges of a typical user of the device (e.g., a user who does not use the device).

[0195] The system 1000 can be used to authenticate a user US based on measured electrical activity of the user's US heart compared to a 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 operations 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 (e.g., applications for which only certain users have a license or which only certain users have purchased). In some embodiments, the processing device 1110 can be instructed to provide access to certain data or application settings associated with the authorized user US. For example, the processing device 1110 can be instructed to provide access to a contact list of the identified user US, or to an email account or phone history of the identified user US. As another example, the processing device 1110 can be instructed to allow the user US to access a private banking application or conduct a financial transaction (e.g., transfer funds to a different account or purchase an item) using the electronic device. In some embodiments, the computing device 1100 can load user US settings and profiles to provide a customized display to the user. For example, the computing device 1100 can 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.

[0196] In some embodiments, the system 1000 can use a detected heart rate or heartbeat characteristic to determine a mood of the user US. In particular, since the allowable determined characteristics associated with each user US can include a range of values, the processing device 1110 can be instructed to determine a distribution of the detected characteristic in the allowable characteristic range. Using the determined distribution, the processing device 1110 can establish a mood of the user and provide electronic device operations or data (e.g., media) associated with the extrapolated mood.

[0197] In some embodiments, the computing device 1100 can provide media playback based on a detected mood or heart signal of the user US. For example, the computing device 1100 can identify media having a beats-per-minute or other characteristic associated with or related to the heart signal or heart rate of the user US and playback the identified media. As another example, the provided media can have a beats-per-minute that is faster or slower than the current heart rate of the user to encourage the user to exercise more vigorously (e.g., during a workout) or to cool down or relax the user (e.g., at the end of a workout).

[0198] Aspects of the application can also include a process for computing device operation based on a user's US cardiac signal. In a first step, the system 1000 can detect a user's US cardiac signal. For example, a user's US heart rate or heartbeat can be detected using the sensors 1210 of the external device 1200. The external device 1200 can transmit the detected signal to the computing device 1100 through the connection 1235. The computing device 1100 can process the received signal using any suitable method, including determining unique characteristics of the signal. Such characteristics can include, for example, the duration between peaks in an EKG signal, the peak or distribution between peaks in an EKG signal, or any other suitable characteristic as described herein. In a further step, the computing device 1100 can determine whether the previously detected user US is an authorized user. For example, the computing device 1100 can compare the determined characteristics of the detected cardiac signal to a library of signals associated with known authorized users. If the computing device 1100 determines that the user US is not authorized (e.g., the characteristics of the detected cardiac signal do not match the characteristics of a stored cardiac signal in memory), the computing device 1100 can prevent access to restricted electronic device operations in a further step. For example, the computing device 1100 can prevent the user from accessing personal or private information associated with other users. As another example, the computing device 1100 can prevent the user US from accessing applications or operations associated with a particular user (e.g., an application purchased by the particular user). As yet another example, the computing device 1100 can prevent the user US from accessing any electronic device operations (e.g., no operations except for emergency calls).

[0199] If the computing device instead determines that the user US is authorized, the process can proceed to a fourth step in which the computing device 1100 determines restricted operations associated with the user US. For example, the computing device 1100 can determine particular private data associated with the authorized user (e.g., an email account, a contact list, and banking information). As another example, the computing device 1100 can determine particular operations or applications associated with the authorized user US (e.g., an application purchased by the user US using an application store, or a system that controls and manages operations associated with a management account). In a fifth step, the computing device 1100 can provide access to the determined restricted operations of the user US. For example, the computing device 1100 can load the determined data. As another example, the computing device 1100 can provide a link for launching the determined personal or private application.

[0200] The first application 1170 can also run in the background of the operating system 1160 to perform one or more of receiving, storing, and analyzing physiological data when the second application 1180 is in the foreground of the display 1195 and being actively manipulated by the user US. For example, the second application 1180 can comprise an email application, a web browser, a music player, or a game in which the user US is operating the first application 1170 and the external sensor device 1200 is measuring the user's physiological parameter(s) in the background.

[0201] For example, the external sensor device 1200 can comprise a number of form factors depending on the form of the computing device 1100 and convenience to the user US.

[0202] Figures 2A to 2K A biometric or physiological parameter measurement and monitoring system 2000 is shown comprising a smart phone 2100 and a protective smart phone case 2200. Figure 2A A perspective view of the system 2000 is shown in which the smart phone 2100 and the protective smart phone case 2200 are separate. The protective case 2200 has a cavity 2200C for housing the smart phone 2100. Figure 2B And Figure 2C A back view of the system 2000 is shown. Figure 2D A perspective view of the system 2000 is shown in which the smart phone 2100 and the protective smart phone case 2200 are coupled or removably attached to each other. The smart phone 2100 can comprise, for example, an Apple iPhone, a Google Android smart phone, a Google Nexus, a Samsung Galaxy phone, an HTC smart phone, a Nokia Windows smart phone, or a Blackberry smart phone, among others.

[0203] The smart phone 2100 can comprise a front face 2110, an edge 2120, a back face 2130, and a display 2140 on the front face 2110. The protective smart phone case 2200 can comprise a plurality of electrodes for detecting physiological parameters such as electrocardiograms (ECGs). The plurality of electrodes can comprise a first electrode 2210 and a second electrode 2220. When the smart phone 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 smart phone 2100. In this way, for example, for the convenience of the user, a thin profile and low profile of the smart phone 2100 can be maintained. As shown, the first electrode 2210 and the second electrode 2220 can be disposed on the top edge and the bottom edge (i.e., the shorter edges) of the protective case 2200 opposite each other, respectively. As shown, the first electrode 2210 and the second electrode 2220 can be disposed on the top edge and the bottom edge of the protective case 2200 opposite each other, respectively. Figure 2B Figure 2C the first electrode 2210 and the second electrode 2220 can be disposed on the top edge and the bottom edge of the protective case 2200 opposite each other, respectively.​2 0 can be disposed on the left and right edges (i.e., the longer edges) of the protective housing 2200, respectively, opposite each other. Figure 2B and 2C The back 2200B of the protective housing 2200 is shown. The electrodes will typically be electrically isolated from each other to avoid shorting or interference. The electrodes will also typically protrude minimally from the body of the protective housing 2200. For example, the electrodes can be polished, roughened, or otherwise finished to match the outer surface of the protective housing 2200.

[0204] The sensor electrodes described herein can be constructed of any suitable material. For example, the electrodes can be constructed of a particular material selected for particular conductive properties that permit more effective transmission of electrical signals reflecting the user's heart activity. The electrodes can be constructed of silver-based compounds, 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 adequate contact between the user (e.g., the user's hand or fingers) and the electrodes. For example, the electrodes can include pads or extended areas placed on the outer surface of the body of the external sensor device 1200.

[0205] In use, as shown in Figure 2E and Figure 2F The user can hold the system 2000 with their hands to bring the first electrode 2210 into contact with the user's right arm RA and the second electrode 2220 into contact with the user's left arm LA to measure one or more physiological parameters such as heart rate or ECG, as shown in Figure 2E The first application 1170 can be active on the system 2000 and displaying the measured parameters in real time, as shown in Figure 2F The 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, as shown in By bringing the 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.

[0206] Other placements of the multiple electrodes are also contemplated. As shown in Figure 2G The first electrode 2210 and the second electrode 2220 can be disposed on the corners of the protective housing 2200. In addition, the multiple electrodes can include a third electrode 2230. As shown in Figure 2HAs shown, the first and second electrodes 2210 and 2220 can be disposed on the top and bottom edges (i.e., the shorter edges) of the protective housing 2200, while the third electrode 2230 can be present on the sides or longer edges of the protective housing 2200. As shown, Figure 2I As shown, the first and second electrodes 2210 and 2220 can be disposed on opposite corners of the protective housing 2200, while the third electrode 2230 can be present on the sides or longer edges of the protective housing 2200. As shown, Figure 2J As shown, the first and second electrodes 2210 and 2220 can be disposed on the left and right edges (i.e., the longer edges), while the third electrode 2230 can be present on the back 2200B of the protective housing 2200. In some embodiments, the first and second electrodes 2210 and 2220 can be disposed on the edges of the protective housing 2200, and the third electrode 2230 can be disposed on the back 2200B of the protective housing 2200.

[0207] In use, as shown, Figure 2K A user can hold the system 2000 in their hand to bring the first electrode 2210 into contact with the user's right arm RA, the second electrode 2220 into contact with the user's left arm LA, and the third electrode 2230 into contact with the user's left leg LL to measure one or more physiological parameters such as heart rate or ECG, as shown, Figure 2K As shown, the 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 the multiple electrodes into contact with the right arm RA, left arm LA, and left leg LL, lead I ECG, lead II ECG, and lead III ECG can be measured. Even lead I ECG, lead II ECG, and lead III ECG can be measured simultaneously. Wireless ECG devices with three electrodes are further described in commonly owned U.S. Provisional Patent Application No. 61 / 845,254, filed July 11, 2013, entitled "Three-Electrode Wireless ECG Apparatus," the contents of which are incorporated by reference herein.

[0208] Figures 3A to 3FA biometric or physiologic parameter measurement and monitoring system 3000 is shown that includes a tablet computer 3100 and a protective tablet computer case 3200. The system 3000 can be similar in many respects to the system 2000. Whereas the system 2000 is adapted for use with the smartphone 2100, the system 3000 is adapted for use with the tablet computer 3100. The tablet computer 3100 can include an Apple iPad, a Google Nexus tablet, a Samsung Galaxy tablet, or a Microsoft Surface tablet, among others.

[0209] Figure 3A A perspective view of the system 3000 is shown, with the protective case 3200 having a cavity 3200C for housing the tablet computer 3100. The tablet computer 3100 has a front face 3110, an edge 3120, a back face 3130, and a display 3140. Figure 3B The tablet computer 3100 is shown coupled or removably attached to the protective case 3200.

[0210] Figure 3B It is also shown that the tablet computer protective case 3200 can include a plurality of sensor electrodes including a first electrode 3210 and a second electrode 3220. As Figure 3B and Figure 3C shown, the first electrode 3210 and the second electrode 3220 can be disposed opposite one another 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 face 3130 of the protective case 3200. In addition, as Figure 3E shown, the plurality of electrodes can also include a third electrode 3230 disposed on the back face 3130 of the protective case 3200.

[0211] The system 3000 can be used to measure physiologic signals in a similar manner as the system 2000 as described above. For example, the plurality of electrodes of the system 3000 can be in contact with the user US to measure one or more of the lead IECG, the lead II ECG, and the lead III ECG. As Figure 3F shown, the user US can operate the system 3000 and the tablet computer 3100 normally, with the first electrode 3210 contacting the right arm RA of the user, the second electrode 3220 contacting the left arm LA of the user, and the third electrode 3230 (not shown) contacting the left leg of the user. Although Figure 3FThe first application 1170 for managing the detected physiological parameter(s) is shown active on the tablet computer 3100, but it is also contemplated that a second application 1180 is instead active and manipulated by the user US during the first application 1170 and protective enclosure 3200 sensing and detecting the physiological parameter(s).

[0212] Other computing device accessories for simultaneously measuring various physiological parameter(s) of the user US during normal use of the computing device are also contemplated.

[0213] Figures 4A to 4C A biometric or physiological parameter measurement and monitoring system 4000 is shown that includes a keyboard 4100 of a computing device 1100 and a keyboard accessory 4200 that can include a keyboard wrist rest. The keyboard 4100 can be removably coupled to the keyboard accessory 4100 (compare Figure 4A to Figure 4B ). The keyboard accessory 4200 includes physiological parameter sensors such as a plurality of electrodes such as a first electrode 4210 and a second electrode 4220. As Figure 4C shown, the first electrode 4210 can contact the right arm RA of the user and the second electrode 4220 can contact the left arm LA of the user to detect a lead IECG during normal operation of the computing device 1100 by the user US.

[0214] Figures 5A to 5C A biometric or physiological parameter measurement and monitoring system 5000 is shown that includes a laptop or palmtop computer 5100 and a sensor accessory 5200. The computer 5100 can be removably coupled to the sensor accessory 5100 (compare Figure 5A to Figure 5B ). The sensor accessory 5200 includes physiological parameter sensors such as a plurality of electrodes such as a first electrode 5210 and a second electrode 5220. As Figure 5C shown, the first electrode 5210 can contact the right arm RA of the user and the second electrode 5220 can contact the left arm LA of the user to detect a lead IECG during normal operation of the computer 5100 by the user US.

[0215] Additional sensor accessories for coupling with everyday use devices are also contemplated. For example, embodiments of the present application can provide sensor accessories for bicycles, motorcycles, handles of exercise equipment such as treadmills or elliptical machines or weight machines, seats, chairs, a pair of glasses, clothing, etc. As another example, the sensor systems described herein can be in the form of a watch, wristlet, wristband, or accessory to these devices. ECG sensing watches and wristlets are described in commonly owned U.S. Provisional Patent Application No. 61 / 872,555, filed August 30, 2013, entitled "Ultrasonic Transmission of Signals from an ECG Sensing Wristlet." The sensor accessories can detect and measure one or more physiological parameters and communicate the measurements to a computing device associated with the everyday use device or another computing device.

[0216] Figure 6 A method 6000 for biometric or physiological parameter measurement and monitoring is shown. In step 6050, a computing device such as computing device 1100 described herein can be provided. In step 6100, an external device or case for the computing device such as external device 1200 described herein can be provided. In step 6150, the external device or case can be coupled to the computing device. See, for example, system 2000 Figures 2A to 2D ), system 3000 Figures 3A to 3B ), system 4000 Figures 4A to 4C ), and system 5000 Figures 5A to 5C ) described herein. In step 6200, a physiological signal or parameter measurement and monitoring application can be downloaded onto the computing device. The application can include first application 1170 described above and can be downloaded from an application distribution platform over the Internet as described herein. In step 6250, the application can be run on the computing device. In step 6300, the external device or case coupled to the computing device can be brought into contact with a user to measure a physiological parameter(s). In step 6350, a physiological signal(s) or parameter(s) can be measured. In step 6400, the physiological signal(s) or parameter(s) can be stored, displayed, or otherwise processed. In step 6450, the physiological signal or parameter measurement and monitoring application can be placed in the background of the computing device. In step 6500, a second application can be run on the computing device while the physiological signal or parameter measurement and monitoring application is doing its work in the background.

[0217] While the above steps illustrate a method 6000 of biometric or physiological parameter measurement and monitoring, those of ordinary skill in the art will recognize many variations based on the teachings described herein. The steps can be completed in different orders. Steps can be added or omitted. Some of the steps can include sub-steps. Many of the steps can be repeated as often as is beneficial.

[0218] One or more of the steps of the method 6000 can be performed with circuitry as described herein (e.g., one or more of a processing device or logic circuit of a computing device or accessory thereof). The processing device or logic circuit can be programmed to provide one or more of the steps of the method 6000, and the program can include program instructions stored on a computer-readable memory or programming steps of a logic circuit.

[0219] Generally, described herein are devices and methods for generating an electrocardiogram (ECG) from a patient including a handheld wireless telecommunication device case having three electrodes on an outer surface of the case, and methods of use thereof. These devices and methods can permit a user to acquire up to six leads (e.g., leads I, II, III, aVR, aVL, and aVF) using a single handheld device that is easily held against his or her leg while viewing a display of the device. In particular, the device can be used in conjunction with a mobile telecommunication device (e.g., a smartphone). In another embodiment, the device is capable of operating as a standalone device, with appropriate circuitry to function independently or communicate with a separate telecommunication device.

[0220] Generally, the devices (including apparatuses and systems) described herein can include three electrodes and be configured for use with a wireless telecommunication device. The wireless telecommunication device can be any appropriate telecommunication device including a smartphone (e.g., iPhone™, Android™, etc.), tablet (iPad™, etc.), laptop, PDA, etc. The device can be configured as a case and / or accessory for a mobile telecommunication device. The device can communicate information wirelessly to the mobile telecommunication device. In some variations, the systems described herein send information to a mobile telecommunication device that has been configured to receive and analyze information from the device (e.g., through an operating program or application ("app"), etc.).

[0221] Thus, generally, the devices described herein can include a housing configured as a case or the like. The housing generally includes an outer surface on which three (or, in some cases, more) electrodes are arranged. In variations in which the housing is configured as a case to hold a mobile telecommunication device, the case can have an outer back surface and at least two outer side surfaces perpendicular to the back surface, and a front region through which a picture of the telecommunication device held in the case can be viewed.

[0222] For example, Figures 9A to 9D One variation of a case configured as a housing for a smartphone is illustrated. In this example, a housing 300 is shown with a mobile telecommunications device (smartphone) 301 housed within the housing. The housing 300 includes a back face (shown) and a side face (shown). Figure 9C The front face of the housing 300 in this example has an opening 301 through which the front face (including the screen) of the smartphone can be seen and / or touched. The housing can also include openings on the side face for phone controls (e.g., volume, power, etc.). Figure 9B And Figure 9D The side face of the housing 300 in this example has an opening 302 through which the side face of the smartphone can be seen and / or touched. The housing can also include openings on the back face for phone controls (e.g., volume, power, etc.). Figure 9B

[0223] Generally, the case also includes at least (and in some variations, exactly) three electrodes, each for contacting a subject’s right hand, left hand, and leg. For example, a first electrode can be configured to be held against a patient’s leg. A second electrode and a third electrode can also be configured and arranged on the case so that a patient can touch the second electrode with their right hand and the third electrode with their left hand while holding the first electrode against their leg. The position, shape, and / or size of the electrodes can be configured so that when measuring an ECG, a patient’s hands do not contact more than one electrode on the case, and a patient’s leg does not contact more than one electrode on the case. For example, the first electrode can be located on a side face or side edge (rear side edge) or both of the case, while the second electrode and the third electrode are located on the back face, and all of the electrodes are separated far enough from each other to avoid leg or hand contact with more than one electrode. Thus, a left hand can contact a single electrode, a right hand can contact another electrode, and a leg can contact the first (leg) electrode all on the same case.

[0224] In Figure 9A , the electrodes are arranged so that the first electrode 309 is on one of the outer side surfaces of the housing. Placing the first electrode on a side face of the housing can allow the first electrode to be easily held against a subject’s leg while the patient is holding 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.

[0225] ​Generally, 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 elements) to protect the one or more electrodes from contact with a surface, such as a workbench or the like, when the device is disposed on the surface. In the case of placing the device onto a conductive surface (e.g., a metal workbench), the housing or additional features can prevent the outer surface 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 outer housing with the rear surface facing the workbench surface is placed on the workbench surface, the outer contact surfaces of the first, second, and / or third electrodes do not contact the workbench surface.

[0226] As noted above, placing the first electrode on the side surface can allow the device to be used to take measurements from the leg while viewing a surface (e.g., a screen) of a telecommunications device within the housing.

[0227] In Figures 9A to 9D , the housing includes only three electrodes 309, 311, and 313, and the first (leg) electrode is on a side outer surface of the housing. The side (first) electrode is configured to extend along a majority 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 Figure 9B and Figure 9D , the housing protects the second and third electrodes, as the electrodes are lower in height than the outer surface of the rest of the housing.

[0228] Figures 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, as shown in Figure 10D , the third electrode protrudes from the outer surface. The housing shown is otherwise similar to the variation shown in Figures 9A to 9D , although these figures are shown without a mobile telecommunications device (e.g., a smartphone) within the housing.

[0229] In some variations, as shown in Figures 11A to 11C , the leg electrode (electrode 1) 509 extends from the side surface to the rear surface where the other electrodes 511, 513 are located.

[0230] Alternatively, in some variations, as shown in Figure 12C , the leg electrode is located near an edge of the housing (e.g., near a side edge). Generally, the leg electrode can be adjacent to one of the side surfaces. The electrode can be immediately adjacent to the side surface and can contact the edge. Figures 12A to 12CAn example housing configured such that the first electrode 613 is adjacent to the side of the housing; the second and third electrodes 609, 611 can be offset away from the first electrode to prevent inadvertent contact by the subject's hands and leg electrodes (or another electrode).

[0231] Figures 13A to 13C Another variation of the housing is illustrated, as shown, having a first electrode 709 extending from the back 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 back of the housing, while the first electrode extends from the outer surface. This can make it easier to contact the leg and hold the housing at an angle.

[0232] In some variations, the housing can be configured to hold an electrode unit that fits within an opening in the outer back surface of the housing; the electrode unit includes the second and third electrodes (and in some variations, the first electrode), and can also include circuitry for controlling / receiving ECG recordings. For example, Figures 14A to 14C An example device configured as a housing that holds an electrode unit 805 including second and third electrodes 811, 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 worktable surface when the device is set on the worktable.

[0233] Figures 15A to 15C Another variation of a three-electrode housing is illustrated, as shown, where all three electrodes (first 909, second 911, and third 913) are arranged on the back surface of the housing.

[0234] 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 can be configured to extend from the surface of the housing. For example, in Figure 16A and Figure 16B In some variations, the first electrode can be configured to extend from the housing on a wire. For example, in

[0235] For example, Figure 17A method of operating the device 400 with two hand (right hand, left hand) electrodes and a leg electrode is illustrated. In this example, the subject SU is sitting in a chair CH and holding the device 400 configured to hold a smart phone case holding a smart phone with both hands such that each hand only contacts one electrode on the back of the case. The case is held against the subject's leg such that the leg electrode is pressed against the leg. Then, as described above, the case and smart phone can be used to record leads I, II, and III from which at least three additional leads can be determined. Specifically, augmented leads (aVR, aVL, and aVF) can be determined.

[0236] 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., voltage between left arm and right arm) simultaneously with lead II (e.g., voltage between left leg and right arm), and lead I simultaneously with lead V2. In other embodiments, any other combination of leads is possible. The processing logic can then align the two sets of recording times so that the two sets of measurements can be compared over the same analog time period.

[0237] 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., neural network, deep learning techniques, etc.) to make this transformation. The machine learning model can be trained using 12-lead ECG data corresponding to a population of individuals. The data can be pre-processed before being input into the machine learning model in order to filter the data in a manner suitable for the application. For example, the data can be categorized according to height, gender, weight, nationality, etc. before being used to train one or more machine learning models, such that the one or more models so derived are fine-tuned for a particular 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.

[0238] In one embodiment, using the machine learning techniques described herein, a complete 12-lead ECG can be generated in a single device using only three electrodes. As described herein, the three electrodes can be positioned on the device in any suitable manner, including two on the front face of the device and one on the back face.

[0239] Generally, described herein are also devices and systems for transmitting information (e.g., biometric parameter information) from a wearable (e.g., wristband) sensing device to a telecommunication device using ultrasonic waves, which telecommunication device can then process and / or transmit the biometric parameter information. In particular, the biometric parameter can include an ECG signal. The wearable device generally 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 variations described herein, these devices are configured as wristbands to be worn by a subject.

[0240] As will be described in detail below, in some variations, the ultrasonic signals (e.g., encoding ECGs) can be securely transmitted using an encryption key. Described herein are also systems, methods, and devices for easily pairing an ultrasonic transmitting device with a telecommunication device using an encryption key. For example, in some variations, the telecommunication device can read an encryption key displayed on the ultrasonic transmitting device (e.g., take an image thereof). This technique can be easily performed by taking an image of a marker (e.g., barcode, QR code, etc.) containing the encryption key with the telecommunication device and determining the encryption key based on the image. Executable logic (e.g., decryption logic) running on the telecommunication device can be configured to interpret and apply the encryption key.

[0241] For example, a system capable of transmitting digital biometric parameter information using ultrasonic waves can include a sensor for sensing a biometric parameter (e.g., a vital sign), a processing device for configuring a representation of the biometric parameter as a “digital” ultrasonic signal, an analog signal, or a hybrid digital / analogue signal, and a transducer for converting the ultrasonic signal so that it can be transmitted in the open air to a telecommunication-capable device. The processing device can be part of, controlled by, or in communication with a controller (e.g., microcontroller). The telecommunication-capable device (telecommunication device) can include a receiver (audio receiver) capable of receiving audio signals in the ultrasonic range, and a processing device for converting the ultrasonic signal back to an electronic signal for further processing or transmission.

[0242] The human hearing range is often referred to as 20 Hz to 20 kHz, however, in ideal laboratory conditions, the maximum hearing range of children is actually as low as 12 Hz, and in rare cases as high as 20 kHz. Furthermore, as shown in Figure 18 the threshold frequency (i.e., the minimum intensity that can be detected) rises rapidly to a pain threshold between 10 kHz and 20 kHz. Thus, sounds above about 16 kHz must be fairly intense to be heard. This threshold sound level for these higher frequencies increases almost from birth. As shown in Figure 19As shown, the average 20 year old has lost about 10 dB in the 8 kHz range, while at 90 years of age, the average person has lost over 100 dB at that frequency.

[0243] An example product that uses very high frequency sound is the mosquito alarm, a controversial device that emits an intentionally annoying 17.4 kHz alarm and is used to deter young people from loitering. Since adult hearing is lost 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 15-17 kHz "mosquito" ring tones on their phones during school hours. Students can hear the mosquito ring tone while their adult teachers cannot. The term "ultrasonic" generally means above the range of human perception. However, as shown, the upper limit of the hearing frequency generally varies with the individual and age. Due to this difference in upper limit, the term "ultrasonic" as defined herein and in the appended claims can refer to a sound frequency of 16 kHz or greater (e.g., greater than about 17 kHz, greater than 18 kHz, etc.).

[0244] Interestingly, however, there are almost no environmental sounds or noises above about 10 kHz. Referring to Figure 20 , most everyday sounds occur at frequencies below about 4 kHz. Thus, the use of signals in the ultrasonic range not only is silent to the surroundings, but also provides a very desirable signal-to-noise ratio (SNR).

[0245] Acoustic engineers safely assume that any frequencies above about 20 kHz will have no impact on perceived sound, and all content above this range can be filtered. Sound in the ultrasonic range below 20 kHz is almost unattended and the standard sampling process is 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 that satisfies fs / 2 > f, where f is the sinusoidal frequency. Because of this, sound systems are designed to sample sound at the now standard sampling rate of 44.1 kHz, which is set slightly above the Nyquist-Shannon sampling rate of 40 kHz calculated for a 20 kHz sound upper limit. Actual demodulation of FM narrowband signals in the ultrasonic range using existing demodulation processes, computers, telephones, cell phones, stereo systems, etc. will result in a very poor reproduction of the original signal. This is unfortunate because, as noted above, a carrier signal 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.

[0246] Apparatuses, methods, and systems for measuring physiological signals (e.g., biological parameters) and wirelessly and silently transmitting digital information related to these measurements use ultrasonic signals that have greatly improved signal-to-noise ratios compared to traditional telecommunication methods. Methods and algorithms are also provided for receiving and demodulating ultrasonic signals with superior accuracy using existing computer and smartphone technology.

[0247] Figure 21A An illustrative overview of a system including data input 0433 (e.g., providing any kind of information, including digital and / or analog information) and microcontroller 0405 is shown. In some variations, the microcontroller includes or is coupled with processing means for encoding a digital representation of a biological parameter, and as described in greater detail below, this encoded signal can be converted to an ultrasonic signal. For example, the encoded signal can be transmitted with ultrasonic waves by 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 telecommunication device 0425 including an audio pickup (receiver) 0429. The telecommunication device 0425 can run client control logic 0427 that prepares the telecommunication device to receive and interpret the ultrasonic signal so that it can be processed, e.g., converting the ultrasonic signal back to an electronic signal and interpreting what kind of signal the ultrasonic signal is (e.g., pulse rate, temperature, etc.).

[0248] Figure 21B An illustrative overview of a system including a medical sensing device 0401 (e.g., a thermometer or blood glucose monitor, etc.) 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 is shown. The microcontroller can include or be coupled with processing means for encoding a digital representation of a biological parameter, and as described in greater detail below, this encoded signal can be converted to an ultrasonic signal. For example, the encoded signal can be transmitted with ultrasonic waves by ultrasonic transducer 0407. This ultrasonic signal 0420 can then be received by a telecommunication device 0425 including an audio pickup (receiver) 0429. The telecommunication device 0425 can run client control logic 0427 that prepares the telecommunication device to receive and interpret the ultrasonic signal so that it can be processed, e.g., converting the ultrasonic signal back to an electronic signal and interpreting what kind of signal the ultrasonic signal is (e.g., pulse rate, temperature, etc.).

[0249] Accordingly, 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 produce electrical signals representative of the sensed physiological signals, and these signals can be converted to one or more digital signals that are input to a microcontroller or other associated components. This digital signal can be displayed on a device (not shown) and can also be electrically encoded as part of a digital signal that can then be encoded with ultrasound (e.g., by techniques such as frequency shift keying) into ultrasound sound and emitted from the device. The encoding of the signal can be performed by any appropriate circuitry, for example including a microcontroller such as an MSP430 (e.g., AFE4110 from Texas Instrument).

[0250] The center frequency can be selected from any appropriate ultrasound 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, a telecommunication device. In some variations, the medical sensing devices are configured to send and receive ultrasound (sound) frequency information (see, for example, Figure 21C and Figure 27 ). Further, in some variations, multiple channels (frequency channels) can be used.

[0251] In Figure 21C , a schematic 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 telecommunication device) is shown. In this example, the device (e.g., wristband) includes a sensor 0403. In some variations, the sensor can include two or more electrodes to detect ECG signals. The ultrasound transducer can be configured as both an ultrasound transmitter and an ultrasound receiver. In some variations, the same transducer element (e.g., piezoelectric element) can be used for both. The telecommunication device 0425 can be configured to receive (via audio pick-up 0429) and transmit (via ultrasound transmitter 0433) ultrasound such as ultrasound transmitted by the medical sensing device 0401.

[0252] In one embodiment, the center frequency of the ultrasound wave signal is in a range from about 17 kHz to about 32 kHz. In another embodiment, the center frequency of the frequency modulated ultrasound wave signal is in a range from about 18 kHz to about 24 kHz, or from about 20 kHz to about 24 kHz.

[0253] Figure 22One variation of a digital signal that has been encoded using key-shift coding is shown. In this variation, the ultrasound signal is modulated at two different frequencies, one representing high ("1") and one representing low ("0"). For example, the frequencies of 0 and 1 can be chosen to be centered at 20 kHz (e.g., 19.5 kHz and 20.5 kHz).

[0254] In some variations, as described above, the sensor encodes an ECG signal, however in general the sensor can comprise any suitable sensor operable to detect a physiological signal that the user desires to monitor. Multiple sensors can be included. Non-limiting examples of such physiological signals include, but are not limited to, respiration, heartbeat, heart rate, pulse oximetry, photoplethysmogram (PPG), temperature, etc. A respiration detector can be used. Heartbeat and heart rate can also be detected. For example, a pulse oximetry sensor can 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 a person's body, such as a fingertip or earlobe, and light containing red and infrared wavelengths is passed from one side to the other. Changes in absorbance of each of the two wavelengths are measured, and this difference is used to estimate the oxygen saturation of the person's blood and changes in the amount of blood in the skin. A photoplethysmogram (PPG) can then be obtained using a pulse oximeter sensor or with an optical sensor using a single light source. The PPG can be used to measure blood flow and heart rate. The digital representation of this data can then be used and communicated as described herein. In some variations (referenced below Figure 26A and Figure 26B In some variations (described below), analog information can also be encoded and / or appended to the digital information to form a mix of analog and digital information that is transmitted by the ultrasound wave transmitting device.

[0255] In some variations, the transducer assembly converts the electrical (e.g., digital, analog, etc.) encoding of the biological parameter into an ultrasound signal that can be transmitted. In the embodiment shown, Figure 21A In the embodiment shown, the transducer assembly 0405' includes an ultrasonic transducer 0407 for outputting an ultrasonic wave signal. Non-limiting examples of suitable ultrasonic wave transmitters (including transducers) include, but are not limited to, a micro-speaker and a piezoelectric buzzer, etc.

[0256] Within the telecommunication device 0425, the ultrasonic wave signal can be received, for example, by a microphone 0429 in a device such as a smart phone, a personal digital assistant (PDA), a tablet personal computer, a pocket personal computer, a notebook computer, a desktop computer, and a server computer, etc.

[0257] The volume of the signal can be kept low to conserve power, although higher volumes are possible as the sound is inaudible. For example, the volume of the signal can be further increased at ultrasonic frequencies without concern that there is an "audience" that can hear the signal. Moreover, the signal can be encoded to prevent other devices (that are not paired with the ultrasonic transmitting device) from receiving and understanding the signal.

[0258] As noted above, the telecommunication device can include processing means configured by client logic (e.g., software) to receive and process the ultrasonic signal. For example, software on a smart phone can decode the ultrasonic signal. The processing of the data can provide additional information related to the user (including the type of information (e.g., nature of the biological parameter)). For example, the signal can 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., last 4 digits after the decimal point); 12 pulses representing that the signal is a blood pressure reading (e.g., 3 digits for systolic, 3 digits for diastolic, and 3 digits for pulse rate); 14 pulses representing that the signal is pulse oximeter data (e.g., 3 digits for 02 sat and 3 digits for pulse rate); 16 pulses representing that the signal is a blood glucose meter data (e.g., 3 digits for blood glucose level); and so on. There can be a "delimiter" between the digits and an EOM (end of message) indicator. In practice, the signal can be sent several times so that comparisons can be made between the received data for verification.

[0259] In one variation, the signal can be encoded such that (assuming 8-bit bytes plus start and stop bits): a certain number of AA or 55 are allowed for synchronization; a byte representing a version number; a one-byte length of the remainder of the packet; a one-byte packet identifier (0x01 for BP, 0x02 for pulse ox, 0x03 for glucose, etc.); data; and an 8-bit CRC.

[0260] In some variations, the signal can also include a segment of analog data (e.g., signal over time, signal over distance, etc.) for transmission with the digital information, including formatted analog data or information extracted (e.g., scaled) from the analog data. For example, a signal for transmission from an ultrasonic transmitting device by ultrasound can include one or more digital portions and one or more analog portions. The digital portions can include information extracted from the analog signal, such as scaling (e.g., maximum and / or minimum), duration, average, etc. The analog, digital, and analog and digital (hybrid) signals can be encoded (including encrypted) and / or can include error correction codes.

[0261] As noted above, the signals can have a time and / or date stamp. In some variations, the device or system can be configured to take multiple measurements and send them in batches or bursts to the telecommunication device. For example, measurements can be taken at times ti, t2, etc., and the measurements stored on the device (e.g., thermometer, blood glucose meter, etc.) and transmitted to the telecommunication device (e.g., smart phone, tablet, etc.) at a later time (tn) using ultrasound. The data can be processed by the telecommunication device and / or uploaded to an external server, etc. (e.g., cloud).

[0262] The baud rate of the transmitted ultrasound data can be selected to allow for fast transmission. For example, if a baud rate of about 300 baud is used, then even for batched signals, the transmission can take less than a second. In some variations, the baud rate is about 400.

[0263] As noted above, the raw signals from the sensors, as well as derived information, can be displayed and stored locally on the smart phone, as well as transmitted to a web server over an internet connection. 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 smart phone, and also include further analysis and reporting.

[0264] Ultrasonic signaling as used herein generally refers to the use of ultrasonic signals to convey information, such as the amplitude of a biological parameter and the origin of a biological parameter measurement, etc. As noted above, these ultrasonic signals can be encoded to allow for transmission and processing. The encoded signals can then be converted to 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 shifted to ultrasonic frequencies. Another example of converting signals 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, multiple frequency signaling, or multiple frequency carrier signaling, such as spread spectrum communication, can be used. An example of multiple frequency carrier signaling is to specify a predetermined set of frequencies separated by intervals, such as intervals between 40 Hz and 100 Hz, such as approximately 65 Hz, etc., for example between 20 kHz and 22 kHz, or between 20 kHz and 24 kHz, or generally between a lower limit of 19 kHz and an upper limit equal to or slightly below the Nyquist frequency of the intended receiver's sampling rate, and for each such frequency, to encode a "1" bit as the presence of a carrier signal, such as a sine wave at that frequency, and to encode a "0" bit as the absence of such a signal. A receiver of such a multiple frequency signal can then take a fast Fourier transform or correlation techniques known in the art to identify whether a carrier is available at each relevant frequency, and from that to deduce the set of bits encoding a number. In some embodiments of multiple frequency carrier signaling, multiple samples can be taken over time and averaged, and the averaged signal can then be processed as described above, for example when the signal is not sufficiently clear. In some embodiments of multiple frequency carrier signaling, a Viterbi decoder can be used to decode the bit pattern, for example in cases where the frequencies are sufficiently close to cause interference. In general, techniques known to those skilled in the art of communications, particularly with respect to modulation and demodulation (e.g., modems), can be employed. Examples of such techniques include various modem standards promulgated by the International Telecommunications Union T Sector, designated as V.x, where x is an integer, which are incorporated by reference herein in their entirety for all purposes.

[0265] In some embodiments, rather than on the telecommunication device (or in addition to the telecommunication device), a server can perform signal analysis to determine encoded data. In some embodiments, signals can be stored at the server and provided to personnel for refinement of transmission and / or reception techniques.

[0266] As noted 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 memory (e.g., DRAM or SRAM, which in some embodiments can 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 memory such as flash memory coupled to and / or incorporated in the processing device. The signal generator can generate ultrasonic signals transmitted as described above. In some embodiments, waveforms for transmission can be stored in persistent memory. In some embodiments, the transmitter includes a power source and / or battery, or uses a power source used to power other components on the medical sensing device. As noted above, the transmitter can include a transducer, such as a piezoelectric transducer that converts electrical pulses to ultrasonic vibrations. The transmitter can include an amplifier coupled to the processing device (directly or indirectly, e.g., via an audio digital-to-analog converter (DAC), which in some embodiments can be integrated with the processing device) that provides electrical pulses to the transducer through its output. In some embodiments, the transmitter can include a real-time clock and / or a receiver for receiving a broadcast time signal. In some embodiments, the transmitter can include an encrypter, which can be, e.g., program instructions executed on the processing device, or can be a separate integrated circuit. In some embodiments, the transmitter can include an error correction code generator and / or a check sum code generator, which can be, e.g., software instructions executed on the processing device, or can be a separate integrated circuit. Techniques described herein with respect to transmission and reception of acoustic wave signaling can be performed at a transmitter as described herein in a manner that will be readily understood by those skilled in the art.

[0267] In some variations, transmission from the medical sensing device to the telecommunication device is unidirectional, generally providing simplicity of design, lower cost, and lower power consumption, among other advantages. These advantages are particularly useful when compared to systems in which the medical sensing device includes an additional receiver, including a microphone or antenna for receiving acoustic wave signals. However, in some configurations, the medical sensing device can be adapted to receive a simple indicator signal from the telecommunication device without the addition of a receiver such as an antenna or microphone. For example, in some variations, an ultrasonic transducer (e.g., a piezoelectric speaker) can be used as a 20 kHz sensor to implement a return acknowledgement (ACK). For example, a telecommunication device (e.g., a telephone) can produce a short 20 kHz burst after receiving, decoding, and verifying a CRC to signal to the sensor that the telecommunication device received it correctly, indicating that no retransmission is needed. In other variations, a signal from the telecommunication device can indicate that the telecommunication device is ready to receive a transmission from the biometric measurement device. Pairs or multiple timing signals / acknowledgements can also be used.

[0268] In one example, the device or system is configured such that data transmitted with ultrasound includes forward error correction (FEC), allowing a receiver to correct for N bit errors. This can be particularly useful if the system is configured such that the biometric measurement device (medical sensing device) is a one-way transmission (e.g., unidirectional). FEC can help ensure that data is received correctly.

[0269] In some embodiments, data signaled by ultrasound can be processed to include error correction codes, such as BCH codes, 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 "spray and wait" codes, online codes, Raptor codes, Reed-Solomon codes, Reed-Muller codes, repetition-accumulation 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 can be applied in a single dimension or multiple dimensions, can be combined, and can be combined with error detection codes such as parity checks and cyclic redundancy checks. Error correction codes, depending on their respective techniques, can be decoded and applied to correct transmission and / or reception errors at a receiver or at a server receiving communications from a receiver.

[0270] Example 1: Digital thermometer

[0271] In one example, a digital thermometer can be configured to include a digital ultrasound modem. In this example, a Texas Instrument MSP430-based digital thermometer has been adapted to include firmware such that the firmware can transmit temperature readings (digital data) with ultrasound to a mobile telecommunications device (e.g., an iPhone). Although this example is specific to an APE 4110 microprocessor (a variant of the MSP 430 microprocessor from Texas Instrument), other microprocessors can be used and similarly adapted with firmware, software, and / or hardware to function.

[0272] Generally, a device can capture data (e.g., thermometer temperature readings) and encode the data for ultrasound transmission. The encoded signal can include error checking (e.g., CRC encoding, Hamming codes, 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.

[0273] For example, data received from a thermometer can be encoded and / or encrypted into one or more data packets for transmission. A microprocessor can encode the data, which can then be transmitted 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. Control logic (data ultrasonic modem logic) can configure, encode, and encrypt the data, and can also control the transmission of prepared packets of encoded / encrypted data driven by a speaker (e.g., a piezoelectric transducer). The control logic can also control the timing of the transmission, ensuring sufficient intervals between data bits. Additionally, the control logic can repeat the transmission and time the start of the transmission.

[0274] For example, in one variation, the thermometer typically measures temperature and, once the temperature has stabilized at a certain value, emits an audible beep to alert the user to the value. This thermometer (in its initial, unmodified configuration) includes a microcontroller (e.g., AFE4110) and a piezoelectric speaker; the microcontroller drives the speaker to emit the beep. By modifying / configuring the microcontroller as described herein to include control logic for a digital ultrasound modem, the thermometer can be adapted to transmit thermometer data “wirelessly” (via ultrasound) to a device configured to receive and decode / decrypt signals, such as a smartphone running digital ultrasound modem receiver logic.

[0275] In this example, the microprocessor may include the following (exemplary) code to achieve the above functionality. Figure 23 and Figures 24A to 24E A flowchart illustrating a method for transmitting data is shown. These examples are not limited to digital thermometers but can be used with any device described herein, including ECG transmitters.

[0276] Although the above steps show Figure 23 and Figures 24A to 24E This document describes a method for transmitting data, but those skilled in the art will recognize many variations based on the teachings described herein. These steps may be performed in different orders. Steps may be added or omitted. Some of these steps may include sub-steps. Many of these steps may be repeated as beneficially as possible.

[0277] Figure 23 and Figures 24A to 24E One or more 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 steps of the method, and the program may include program instructions or programming steps of the logic circuit stored on a computer-readable storage medium.

[0278] In any of the systems, devices, or methods described herein, data (including digital, analog, and / or mixed digital / analog data) can be compressed prior to being encrypted. Any appropriate data compression technique can be used. For example, lossy and / or lossless techniques can be used for data compression. Known types of lossy and lossless data compression can be used. For example, Lempel-Ziv (LZ) compression and other statistical redundancy techniques can be used for lossless compression. Similarly, lossy data compression techniques can also be applied. A receiver that executes control logic can decompress the data.

[0279] As described above, a receiver (digital ultrasonic modem receiver) can be used to receive a transmitted ultrasonic signal. The receiver can be a dedicated device that includes a microphone assembly that receives the ultrasonic signal and a processing device (e.g., a microprocessor) that is capable of analyzing the signal, or the receiver can be a device that has a microprocessor and a microphone that is adapted to receive the ultrasonic signal when executing control logic (e.g., digital ultrasonic modem receiver logic).

[0280] For example, Figure 25 An example illustrates one variant of a flowchart of a method for receiving, demodulating, and detecting a digital ultrasonic signal. In this example, an application (receive control logic) receives binary FSK encoded data via a microphone input. For example, the input can be from a microphone on a smartphone. As described above, binary FSK encoding uses a "mark" frequency Fr that represents a binary 1 and a "space" frequency F s These two frequencies. In this implementation, no carrier is used.

[0281] The application consists of two largely independent components: a demodulator that extracts the mark and space frequency components from the raw audio data, and a packet decoder that monitors the demodulated signal for packet transmissions and decodes these. These are illustrated in Figure 25 The demodulator receives audio samples from the microphone hardware at a sample rate S, such that S > 2*max(F m9 F8). The audio samples are processed by two frequency detectors that (respectively) compute the strength of the mark and space frequency components of the received signal. In this implementation, the Goertzel algorithm is used for frequency detection. In order to achieve sufficient frequency resolution between the mark and space frequencies, the Goertzel algorithm is applied to a sliding window of G samples, where G = S / abs(F m -F).

[0282] The Goertzel algorithm outputs for the mark and space frequencies are passed to separate low-pass filters with passbands equal to the baud rate. The filtered output of the mark frequency signal is then subtracted from the filtered output of the space frequency signal. This produces a waveform that is approximately zero when no transmission is occurring, rises to positive values when the "mark" frequency is active, and falls to negative values when the "space" frequency is active.

[0283] The demodulated waveform is then passed to a packet decoder. For each raw audio sample received from the microphone hardware, the demodulator produces a single demodulated sample of the demodulated waveform. The packet decoder receives the demodulated samples from the demodulator. The decoder maintains a buffer of the last N samples received, where N is equal to the length of the synchronization sequence. For each new sample, the decoder evaluates the past N samples in the buffer to determine whether the samples contain the synchronization sequence. A two-stage test is used: first a computationally simple evaluation that eliminates most false positives due to random noise, and then a computationally more expensive evaluation that eliminates the remainder.

[0284] Once a valid synchronization sequence is received, the decoder stores 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 a minimum amplitude threshold for the start bit of each byte. Once a valid start bit is received for a given byte, the subsequent bits are evaluated based on the sign of the demodulated waveform in the absence of a minimum threshold for decoding.

[0285] If no valid start bit is received, the decoder either aborts reading the packet and waits for silence, or until a fixed amount of time has elapsed, before continuing to listen for a new packet. Each logical byte in the 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.

[0286] The first logical byte read is the packet version, which is checked against the supported version number. 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.

[0287] After the data bytes are read, two logical checksum bytes are read, and the received checksum value is compared to the value computed for the received data bytes. If the two checksum values match, the packet is considered valid and can be used for the remainder 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 a packet is received, the decoder resumes listening for a new packet.

[0288] Once the data is received (and decrypted in some variations), any communication capabilities of the telecommunication device can be used to further process and / or store and / or display and / or transmit the data. For example, the data can be displayed on a smart phone and / or uploaded into a medical database for storage and / or later review.

[0289] While the above steps illustrate a method of transmitting data by Figure 25 the person of ordinary skill in the art will recognize many variations based on the teachings described herein. The steps can be completed in different orders. Steps can be added or omitted. Some of the steps can include sub-steps. Many of the steps can be repeated as many times as is beneficial.

[0290] Figure 25 One or more of the steps of the method can be performed with circuitry as described herein (e.g., one or more of the processing devices or logic circuitry of the computing device or its accessories). The processing device or logic circuitry can be programmed to provide one or more of the steps of the method, and the program can include program instructions stored on a computer-readable memory or programming steps of the logic circuitry.

[0291] While the above examples describe systems configured to transmit digital information, the techniques, devices, and systems described herein can also be configured to transmit analog signals and / or analog and digital hybrid signals. Generally, the described techniques 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. Further, in some variations, the output system is not a piezoelectric element, but rather a more traditional speaker (albeit in the ultrasonic range). Additional digital-to-analog (D / A) conversion can occur during transmission.

[0292] For example, Figure 26A and Figure 26B This example illustrates one variation of a hybrid digital / analog format that can be used with an ultrasonic transmitter. Generally, the signal can include a digital component that is modulated or configured for ultrasonic modem transmission. 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 that is appended to the digital information.

[0293] For example, in some variations, the ultrasonic transmitting 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 minima, maxima, analog signal duration, 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 the digital signal (or extracted signal) that can be transmitted to the transmitting element and received by the telecommunication device. In the example of a device configured as a pulse oximetry device (e.g., a plethysmograph), the pulse oximetry device prepares a hybrid data / analog signal by determining the peak, minima, duration, time intervals, etc. of the analog signal (e.g., a time-varying pulse oximetry signal) from the analog signal. Thus, the hybrid signal can include extracted or tagged digital information as well as a waveform (or waveforms) obtained from the device.

[0294] In some variations, the signal can be ECG data. The ECG header information can include digital information related to the analog waveform attached to the digital information, such as duration, pulse rate, information related to the ECG waveform such as interval data, etc. (in the case of pre-analysis).

[0295] The signal can be sent encrypted by a device or user-specific identification code. In general, any of the devices described herein can encode data and can provide an encryption key so that it can be read and understood by a receiving telecommunication device (e.g., a phone, tablet, pad, etc.).

[0296] There are many potential benefits to transmitting a hybrid analog / digital signal that can be read and understood by a telecommunication device. For example, if the hybrid signal includes a series of values (e.g., minima / maxima) 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.

[0297] For example, variations of the ultrasonic transmitting device can include a pedometer, activity monitor, heart rate monitor, etc. In some variations, the signal is formatted so that there is a limited number of points in the analog portion. The ultrasonic transmitting device can then transmit a series of data points (including any calibration points). In one example, a graph of heart rate can include 1000 points within 2 seconds (transmission time) representing a graph of biometric data over time. The signal can include digital values (e.g., encoded as FSK) and analog (e.g., graphical) data. Such a hybrid signal can include the best features of both a digital signal signal and an analog signal alone.

[0298] In one example, as mentioned previously, the ultrasonic transmitting device is a thermometer including the above-described ultrasonic modem element. The ultrasonic thermometer device can be configured to include a temperature range of about 95 °F and 106.7 °C for practical use range. Thus, the temperature can generally be transmitted as having 0.1 resolution (e.g., 120 values, thus 8 bits can be all that is needed). In a device configured to encode biometric data in a hybrid signal, the digital component of the signal can be first appended, and can include information about the analog signal that follows the digital signal only, 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 includes the digital information together. An example of a hybrid signal can include a thermometer device as described above that displays the temperature as a function of time, and measures and / or records and transmits the maximum / minimum temperature, time of measurement, etc., and the signal can also include a temperature waveform showing the time course. Other devices and / or signals (hybrid signals) can include a blood glucose monitoring signal (e.g., ultrasonic transmitting device configured as a blood glucose meter, etc.), which can send a blood glucose signal (including a digital signal of maximum, minimum, etc.) and one or more graphs showing the waveform of blood glucose over time, etc.

[0299] Preparing and transmitting a signal to include both analog and digital information can also allow the system to send more data as a waveform in compressed form, which can be very efficient. For example, a prototype ultrasonic transmitting device applies a particular sampling rate (e.g., 300 or 500 samples / second, where each value is a 16-bit binary value). More data can be efficiently sent as a waveform in compressed form. Including extracted information, such as 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.

[0300] As mentioned, Figure 26A One variation showing a hybrid digital / analogue format that can be used as described herein. In this example, the signal includes an initial digital component 0901 encoded for ultrasonic transmission using a technique such as FSK (or any other technique known in the art). The digital information can be suitably divided into bits, bytes, words, etc. The size and location of the digital information can be predetermined. Error correction codes (e.g., Hamming codes, etc.) can be included. In Figure 26A In this 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), additional data 0909 on the analog signal (e.g., type, timing, data stamp / timestamp, etc.). Any other digital information can be included. After this, the signal can include an analog component 0903. In Figure 26AIn some variations, the analog signal is slightly open, and can persist for a fixed or non-fixed duration; in some variations, the entire signal can be repeated for receipt by the telecommunication device. Figure 26B A similar variation is shown for a mixed signal format, where a digital component 0901 is appended to an analog component 0903, and an appended digital component 0911 (an "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 prior to transmission.

[0301] In some variations, a mixed digital / analogue format can be used to encode stored data that has been held by the device (ultrasound transmitting device) for a period of time. For example, stored data such as hours, days, or weeks of data (e.g., biometric data such as pedometer data) can be prepared as an analog signal (a plot over time) described / calibrated by a digital data component, and transmitted to the telecommunication device.

[0302] In any of the devices, systems, and methods described herein, the ultrasound signals transmitted by the device can be encrypted. Any appropriate encryption method can be used, including encryption methods that use a key, such as Data Encryption Standard (DES) and Advanced Encryption Standard (AES).

[0303] In general, the encryption key for a particular device (e.g., ultrasound transmitting device) can be presented on the device (or on an associated packaging, housing, etc. of the device), so that the encryption key can be easily accessed by a user of the receiving telecommunication device. The encryption key can be prepared as a barcode or other machine-readable format (e.g., QR code), and in particular can use a readable format that is read using a different modality than the ultrasound transmission using the receiving telecommunication device. As used herein, a reference to presenting or displaying an encryption key on an ultrasound transmitting device is intended to include displaying a prepared representation (in particular, a machine-readable representation) on the ultrasound transmitting device, its packaging or associated structure (e.g., housing, etc.). In some variations, the encryption key is prepared as a barcode or QR code and printed on the outside of the ultrasound transmitting device, so that it can be photographed or scanned by the telecommunication device. Machine-executable logic (e.g., client logic, software, firmware, etc.) on the telecommunication device can then determine the encryption key and apply it to decrypt the ultrasound signals received from the ultrasound communication device.

[0304] In this way, the ultrasonic transmission device can be uniquely paired with a private encryption key that can only be read by a telecommunications device that possesses and applies the encryption key. The encryption key is easily displayed and determined by the telecommunications device. Thus, in some variations, each ultrasonic transmission device can have a unique ID printed on the device, providing a code that must be matched with the telecommunications device. Scanning the printed encryption key allows the telecommunications device to decrypt the data.

[0305] Figure 27 An illustrative example includes a variation of a system of ultrasonic transmission devices ("source devices" 01031) having an encryption key 01051 visible on the body of the device that can be read by a telecommunications device 01025 and applied to decrypt the transmitted ultrasonic transmissions. Figure 27 An example of a device and system is also illustrated in which the ultrasonic transmission device ("source device" 01031) is in bidirectional (or limited bidirectional) communication with the telecommunications device.

[0306] As noted above, it can be useful to communicate between a telecommunications device (e.g., a smart phone 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 telecommunications device (e.g., smart phone / computer) can provide an acknowledgement (ACK) of successful receipt of data (with 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 the remote device by sending parameters or information from the telecommunications device (such as calibration data, personal information, etc.).

[0307] For simplicity of acknowledgement, the piezoelectric / speaker used by the device (ultrasonic transmission device) 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 the piezoelectric element as a receiving sensor requires a relatively "loud" signal (even though the signal is inaudible), so the signal should be at the resonant frequency of the most sensitive piezoelectric element. The duration or coding of this "frequency burst" can be configured so as to be easily recognized by the low-power electronics of the healthcare / fitness sensing device. For example, the acknowledgement pulse can be filtered and detected as the presence of only a specific ultrasonic frequency for a predetermined duration.

[0308] In some variations, symmetric two-way communication can be implemented using well-established telephone modem technology, changing only the carrier frequency to the ultrasonic range. For example, telephone modem modulation techniques are based on FSK (frequency shift keying), QAM (quadrature amplitude modulation), and PSK (phase shift keying). These telephone modem techniques assume only two devices are trying to communicate. Radio frequency protocols can be used to augment the modem protocol to allow multiple devices to communicate simultaneously without error.

[0309] Implementation of such two-way communication technology can include additional processing capability in the device sufficient to perform the signal processing required to demodulate and decode received audio. Such processing capability can require additional battery power as well as physical space in the device. A partial list of existing modem communication standards that can be adapted for ultrasonic communication can include ITU V.21 (300 bps, FSK) and ITU V.22 (1200 bps, PSK (phase shift keying)). See, for example, reference web pages such as:

[0310] ftp: / / kermit.columbia.edu / kermit / cu / protocol.html,

[0311] http: / / www.LSU.edu / OCS / its / unix / tutorial / ModemTutorial / ModemTutorial.html,

[0312] http: / / www.dtic.mil / cgi-bin / GetTRDoc?AD-ADA499556,

[0313] http: / / alumni.media.mit.edu / ~wiz / ultracom.html,

[0314] http: / / nesl.ee.ucla.edu / fw / torres / home / Dropbx / good_paper_mico_controller.pdf,

[0315] http: / / edocs.nps.edu / npspubs / scholarly / theses / 2010 / Sep / 10Sep_Jenkinds.pdf.

[0316] Regarding Figure 27, the source device can include additional transducers / microphones for receiving the ultrasonic signals from the telecommunication device and supporting processing (e.g., microprocessor / microcontroller logic) to control the ultrasonic signals, interpret the communication (which can be encoded and / or encrypted), and perform any command functions. Similarly, the telecommunication device can include a speaker (piezoelectric element) configured to emit ultrasonic signals.

[0317] From the above description, it is clear that the presently disclosed and claimed (one or more) inventive concepts are well adapted to attain the ends and advantages mentioned hereinabove, as well as those inherent in the presently disclosed and claimed (one or more) inventive concepts. Although presently presented embodiments have been described for the purposes of the present disclosure, it will be understood that many changes can be made which will readily suggest themselves to those skilled in the art, and which will be

[0318] Example 2: Heart rate monitor using audio tones for heart rate transmission

[0319] Any of the devices, systems, and methods described herein can be configured as a wireless (ultrasonic) heart rate monitor for use in conjunction with a mobile telecommunication (computing) device, such as a smart phone, 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 (e.g., wearable monitor) for sensing heart rate can be configured as a wristband, ankle bracelet, arm band, chest band, waistband, etc. (collectively, “bands”), and can wirelessly communicate information via any of the ultrasonic methods described above, including using receiving control logic (e.g., software, hardware, etc.) to receive, store, and / or analyze sensed (biometric) information.

[0320] Most heart rate monitors consist of a chest band that incorporates an ECG amplifier, R-wave detector, and circuitry for outputting a 5 kHz electromagnetic pulse that is typically 50 ms wide when an R-wave is detected. The electromagnetic pulse is detected by a watch or other receiver that then measures the interval between pulses and calculates and displays the heart rate. This configuration requires a special receiver that can 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, as near-field electromagnetic transfer is typically used.

[0321] In one variation of the devices and systems described herein, the heart rate monitor can comprise a band (e.g., chest band, wrist cuff, etc.) that incorporates an ECG amplifier, R-wave detector, and circuitry for outputting an audio tone (signal) typically 5 ms wide when an R-wave is detected (e.g., in the ultrasound frequency region of approximately 17 kHz to 30 kHz). The audio tone can be detected by a device such as a smartphone or other mobile computing device using the built-in microphone on the smartphone device, and then the interval between tones can be measured and the heart rate calculated and displayed. The mobile computing device (e.g., phone) can include software, firmware, or hardware (although typically software, including an application or "app" that can be downloaded from a remote server) for controlling the mobile device to receive and analyze the audio (e.g., ultrasound) tones, calculate the heart rate, and store, upload, and / or display the heart rate.

[0322] One advantage of this system is that no additional equipment is needed to receive the heart rate information, as the microphone circuitry is already present in the smartphone or other mobile computing device, and the range can be longer, 5 m or more, if desired, depending on the loudness of the audio tone.

[0323] When using audio tones in the range 16 kHz to 32 kHz (e.g., ultrasound, 17 kHz to 30 kHz, 17 kHz to 22 kHz, etc.), these audio tones are inaudible to most people, do not interfere with music or speech, and are also less susceptible to audio interference.

[0324] In some variations, the devices, methods, and systems can be configured so that multiple heart rate monitors can be used in close proximity, or one receiving device receives heart rate information from multiple users simultaneously. It can be desirable that the heart rate information from each heart rate monitor be uniquely identifiable, so that the heart rate information does not interfere with each other.

[0325] For example, the audio tones from each heart monitor can 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.

[0326] A first embodiment is one in which each heart monitor uses a different audio frequency that is spaced sufficiently apart to allow for Doppler shift when the heart rate monitor is moved rapidly relative to the receiver, and to allow frequency discrimination with a high signal-to-noise ratio.

[0327] Thus, each heart monitor does not have to be set to a particular tone frequency, the frequency can be determined by a pseudo-random sequence when the heart monitor first detects an R-wave heartbeat signal after it is first put on. The audio tone is then fixed until the heart monitor is removed. Thus, each monitor does not have to be uniquely encoded.

[0328] In the case where the audio tones emitted by the heart rate monitors are in the range 18 kHz to 22 kHz, a separation of 500 Hz can be used. This allows for 9 possible audio operating frequencies for each monitor.

[0329] A pseudo-random allocation of frequencies to use can be achieved by having a counter that increments with time from the first attachment of the heart monitor to the body, such 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 re-attaching the monitor from the body.

[0330] In the rare case where two heart monitors are using the same frequency and are in close proximity such that there is some possibility of interference, the frequency of one of the monitors can be changed by removing and re-attaching the monitor. The receiving device can also detect such interference and, if necessary, advise the user to remove and re-attach the monitor.

[0331] The receiving device can determine the audio tone frequency of a particular ultrasound 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 calculated by measuring the interval 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.

[0332] A second embodiment is one in which multiple devices (e.g. heart rate monitors) use the same frequency but have audio tones of different durations. The duration of each tone can be measured by the receiving device. Only tones of a particular duration are used to calculate the heart rate of a particular heart rate monitor. In the case where two heart rate monitors are in close proximity such that the receiving device picks up audio tones from both monitors simultaneously, a distinction between the two can be made based on the tone duration. The audio tones are unlikely to arrive simultaneously because the tone duration is shorter than the interval between tones (the heart rate interval), but if they do arrive simultaneously, this can be identified by the receiving device and the heart rate calculation can be adjusted to compensate.

[0333] In some variations, the audio signal emitted when a heartbeat is detected can be digitally encoded (e.g. a burst of multiple pulses including high frequencies), and as described above, the encoding (burst pattern) can be unique or pre-selected (random) and reset by the user (e.g. by removing the device and reapplying it).

[0334] Any of the examples discussed above can be included as part of a method, apparatus, or system (including software). Thus, a system for measuring heart rate can include a monitor (e.g., a heart rate sensor, etc.) that includes a transducer for producing an audio signal (e.g., one or more pulses) timed with the patient's heart rate. Thus, the monitor acts as an audio relay. The audio signal can be in the ultrasound range. The system can 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 can be used instead of or in addition to a smartphone running the control logic.

[0335] In a particular example, the system can 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 the audio signal emitted by the sensor and to calculate a heart rate from the audio (e.g., ultrasound) pulse signal.

[0336] Example 3: Wristband for detecting motion and / or ECG signals

[0337] Figure 28A and Figure 28B Another variation of an example wearable device is illustrated that can detect a health parameter and transmit the health parameter to a monitoring station (e.g., a smartphone) controlled by control logic using ultrasound such that the monitoring station receives the information from the wearable device using ultrasound and / or causes the reception of the information.

[0338] Figure 28A An illustration of an appearance of one variation of a device configured as a wristband is shown. The device can include one or more sensors for detecting biological parameters, such as a motion / vibration sensor, and one or more electrodes, etc. In Figure 28A In a particular example, the outer surface of the device is shown schematically. A first conductive (e.g., metallic) window 01151 is visible on the outer surface of the wristband, and a second conductive (e.g., metallic) 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 electrode can make constant or periodic contact during normal use. The conductive windows can also be thermally conductive and can also be connected to a temperature sensing module.

[0339] The wristband can be flexible such that the wristband can extend over and secure to the wearer's wrist. The wristband can be bendable such that once bent around the wearer's wrist, the wristband remains in place. In some variations, the wristband is open; in some variations, the wristband can be closed (forming a closed loop over the wrist of the subject). The outer surface of the wristband can be sealed from the inner surface to prevent damage and to make the wristband sweat- and water-resistant when worn.

[0340] As noted above with respect to the conductive window regions, the exterior 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 regions are shown above. The regions of the wristband that cover the ultrasound transducers 01184 can also be adapted to permit ultrasound signals to pass through. In some variations, the end portions of the wristband are adapted to permit ultrasound signals to pass through by including relatively rigid end caps that can readily convert ultrasound energy. In some variations, the outer (e.g., polymeric) covering is made of a material that is relatively transparent to ultrasound as known in the art. In some variations, the end regions (or the relative end regions) can also be adapted to allow recharging of the device’s battery.

[0341] Figure 28B An example internal schematic of a wristband that illustrates the internal module (structure) is shown. As noted above, any appropriate sensor(s) can be included, including any of those described above. In this example, the wristband includes a motion sensor 01186, which can be a high-precision motion sensor for tracking body movements. Other sensors in this example include a first electrode 01191 and a second electrode 01192 that can be electrically connected to conductive windows 01151, 01153 on the outer surface. In some variations, the outer surface is the 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 can be in contact with 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 can extend completely around the outer (outward-facing) surface of the wristband. Additional sensors can be included or omitted. For example, in one variation, the wristband includes only a motion sensor, but not electrodes.

[0342] In some variations, the wristband also includes a haptic feedback element, a vibrating motor 01194. This vibrating motor can produce an oscillating frequency to provide feedback from the device to the user. In some variations, the wristband can also include a button or contact area that allows the user to manually trigger one or more functions of the wristband and / or the monitoring station, such as transmitting data by ultrasound, etc. The button 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 a pattern or color, etc.

[0343] The wristband can also include a processing device 01183 for receiving and / or encoding information from one or more sensors, as well as an ultrasound transducer 01184. As discussed above, the transducer can receive encoded / encrypted information from the processing device to transmit via ultrasound. When multiple sensors are included, the information can be encoded to indicate what data is included.

[0344] One or more memory modules (not shown) can also be included to store recorded information. The memory can be integrated with the processing device. In some variations, a separate ultrasound detector 01194 can also be used, or the ultrasound transducer 01184 can be a component capable of both sending and receiving ultrasound signals. Thus, bidirectional communication can be conducted between the device and a monitoring station (e.g., a smart phone running control logic) through ultrasound.

[0345] The wristband can also include a power management system that includes a generally rechargeable battery 01182. The battery can be of relatively low power (e.g., low voltage such as 1.5V) sufficient to power the electronics and the ultrasound transducer. The processing device can manage power (including charging of the battery). The system can indicate that the battery is low and needs recharging (e.g., through a vibration of the warning mode of vibration).

[0346] In operation, the wristband can be worn and used to monitor a subject (e.g., physical activity), and can record and / or wirelessly communicate sensed values of the subject. For example, motion sensor data can be detected through ultrasound and communicated to a mobile computing device (e.g., a smart phone 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 for error correction.

[0347] For example, a wristband device (e.g., an activity monitor) can be worn by a subject. When the wristband device is worn, the device can record the wearer's motion (activity). 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, the electrodes can be used to measure the ECG on the patient (e.g., between the patient's arms). In some variations, the pressing down can also trigger the device to record the electrical potential for that time period. The recorded electrical signals can include information related to the pulse and ECG, which can be communicated directly on the processing device, or initially analyzed by the processing device and then communicated on the processing device (including communicating any analyzed information).

[0348] The device can be configured to continuously (e.g., via ultrasound broadcast) and / or repeatedly communicate data, or it can be configured to handshake with a smart phone (or other receiving station). For example, the wristband device can be configured to stand by until an ultrasound trigger is received by the ultrasound transducer / detector (01184 / 01194) ('ready'). The wristband can then communicate with the receiving station to communicate the collected data through encoded / encrypted ultrasound as described above. The system can be configured to communicate periodically, or to attempt communication when sufficient data has been collected.

[0349] Generally, any of the technologies, components, and / or subsystems described above can be used or combined with any of the examples in the other examples. For instance, any ECG wristband device described herein may include any of the features described above.

[0350] Example 3: ECG detection wristwatch

[0351] exist Figure 29 and Figure 30 The image shows another variation of an ECG measuring device configured to detect ECG signals and transmit ultrasound signals encoding ECG data. In this example, the watch has been modified to include two electrodes. The first electrode (in...) Figure 29 and 30 (Not visible in the center) Located on the back of the watch (“wristband”) and in contact with the wrist of the person wearing the device. For example... Figure 29 As shown, the second electrode 01203 is located on the "front" of the watch 01201. Therefore, the watch can be used as a single-lead ECG sensor to record lead I (left arm / right arm). In some variations, the watch may also include, for example, an additional electrode 01207 on one side of the watch or strap area, which can be held against the subject's leg (right or left leg) to generate (one or more) additional / alternate leads (e.g., lead II, lead III, etc.).

[0352] A watch may also include one or more controls and / or indicators. For example, a watch may also be configured as a clock (displaying the time, etc.). A watch may include buttons, dials, etc., to select functions (e.g., turning ECG reading on / off, starting ECG information transmission, etc.).

[0353] Figure 30 Show Figure 29 The ECG device 01203 shown transmits a variant to the mobile telecommunications device 01205. In this example, the mobile telecommunications device is a smartphone (iPhone™) configured to act as a receiving station for an ECG watch and receive ultrasonic transmissions of ECG information. Therefore, the smartphone is running application software that causes its processing unit to enable an ultrasound-sensitive audio receiver (microphone) to "listen" to the ultrasonic signal. The receiving unit (smartphone) can then process the signal and, while recording the ECG signal, as... Figure 30 The image shows these ECG signals displayed in real time. In this example, the smartphone is continuously receiving, displaying, and recording signals.

[0354] As described above, the signal can be processed before it is 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, after, or between the transmission via ultrasound from the watch and the receiver (e.g., a smartphone).

[0355] 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 broadcast ECG data continuously, or it can transmit only when the receiver indicates that it is ready to receive; in such variations, the device can store the detected ECG data for later transmission.

[0356] exist Figure 29 and Figure 30 In the example shown, the system also determines the heart rate based on ECG information. Additional information can also be extracted from the signal. As mentioned above, the signal can be transmitted by the device (e.g., a wristband) as a digital, analog, or mixed digital / analog ultrasound signal. Furthermore, 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 decryption / pairing between the smartphone (receiver) and the device.

[0357] While 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 retainer for a mobile telecommunications device (e.g., a smartphone) can incorporate any of these aspects, such as the encoding of ultrasonic signals or encoding them as a hybrid digital / analog ultrasonic signal. Therefore, any standalone medical sensor, in addition to wearable medical sensors, can also include any of these features.

[0358] When a feature or element is referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and / or elements can also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected,” “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element, or intervening features or elements can be present. In contrast, 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 intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature can have portions that overlap or underlie the adjacent feature.

[0359] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the present application. 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 stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items and can be abbreviated as “ / ”.

[0360] Spatially relative terms such as “under,” “below,” “lower,” “over,” “upper” and the like can be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device is inverted in the figures, elements described as “under” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of above and below. The device can be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly,” “downwardly,” “vertical,” “horizontal,” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0361] Although the terms "first" and "second" can be used herein to describe various features / elements, these features / elements should not be limited by these terms. These terms can be used to distinguish one feature / element from another feature / element. Thus, a first feature / element discussed above could be termed a second feature / element and, similarly, a second feature / element discussed above could be termed a first feature / element without departing from the teachings of the present application.

[0362] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers can be read as if prefaced by the word "about” or "approximately,” even if the term does not expressly appear. The phrase "about” or "approximately” can be used in describing magnitude and / or position to indicate that the value and / or location described is within a reasonable expected range of values and / or locations. For example, a numeric value can have a value that is + / -0.1% of the stated value, + / - 1% of the stated value, + / - 2% of the stated value, + / - 5% of the stated value, + / - 10% of the stated value, etc. Any numerical range recited herein is intended to include all sub-ranges of the same numerical precision, e.g. 1 to 10 includes 1 to 3, 4 to 6, 5.5 to 10, etc.

[0363] While preferred embodiments of the application have been shown and described herein, it will be apparent to those skilled in the art that many changes, modifications, and substitutions can be made thereto without departing from the application. It is to be understood that various alternatives to the embodiments of the application described herein can be employed in practicing the application. It is the intent of the appended claims to cover all such alternatives and modifications as fall within the true spirit and scope of the application. The claims should be accorded a breadth of interpretation in line with the principles of patent law.

[0364] Figure 31 is a flowchart of a method 3101 for 12-lead ECG using a three-electrode setup in accordance with some embodiments of the application. The method 3101 can be performed by processing logic that comprises hardware (e.g., circuitry, dedicated logic, programmable logic, microcode, etc.), software (e.g., instructions run on a processing device to simulate hardware), or a combination thereof. In one embodiment, the processing logic corresponding to one or more components or methods of Figures 1 to 30 The processing logic corresponding to one or more components or methods of Figures 1 to 30 In another embodiment, any other suitable processing device can perform the described operations.

[0365] Reference is made to Figure 31At block 3103, the processing logic can determine lead I (values) from the first electrical signals of the first electrode and the second electrical signals of the second electrode. Lead I can be computed according to any of the methods described herein. For example, lead I can be computed based on electrical signals 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, the processing logic can determine lead II from the second electrical signals and third electrical signals from the third electrode. In one embodiment, lead II can be computed according to any of the methods described herein. For example, lead II can be computed based on electrical signals 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 places the electrodes for lead I, obtains a measurement, then places the electrodes for lead II and obtains a corresponding measurement). In this case, the processing logic can 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).

[0366] At block 3107, the processing logic can generate lead III (e.g., using lead III = lead II - lead I). In another embodiment, lead III can be generated directly from electrical signals of electrodes contacting the user. At block 3109, the processing logic can determine, by the processing device, leads aVR, aVL, aVF, VI, V2, V3, V4, V5, and V6 based on lead I, lead II, and lead III using a machine learning model trained with 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 the 12-lead output. In another embodiment, as described below with respect to Figure 32 the model can use additional data.

[0367] In another embodiment, the processing logic can determine leads aVR, aVL, and aVF from lead I and lead II using non-machine learning based techniques. In yet another embodiment, the processing logic can also determine V leads from a fourth electrical signal. For example, the processing logic can determine V2 or V5 or any other V lead based on the fourth electrical signal. The processing logic can then determine, by the processing device, leads and the remaining V leads based on lead I, lead II, lead III, and the V lead using a machine learning model trained with measured 12-lead ECG data.

[0368] At block 3111, processing logic can provide leads, i.e., lead I, lead II, lead III, aVR, aVL, aVF, VI, V2, V3, V4, V5, and V6, for display on a client device. In another embodiment, a subset of the twelve leads (or none of the twelve leads) can be provided.

[0369] In one embodiment, a machine learning model is constructed based on a deep convolutional architecture. The input layer processes the multi-lead ECG into a spatial image, with one dimension for the time axis and another dimension for the multiple channels. The ECG channels can have a regular order of leads I, II, III, aVR, aVL, aVF, VI-V6. Alternatively, the ECG channels can have a more physiologically meaningful order called the "Cabrera format," in which the order of frontal plane leads is lead aVL, I, -aVR, II, aVF, III, VI-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.

[0370] Instead of a ID 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 identifies possibly more than one class, such as "myocardial infarction" and "left ventricular hypertrophy" or "right bundle branch block" and "inferior wall ischemia."

[0371] In one embodiment, the model is trained with a large labeled training set with many epochs. 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 train during the training process. The test set is used for final performance checking. The data set is first formed with an existing 12-lead diagnostic ECG database. And a second data set will be formed from actual sampled ECGs from the target device described here. Transfer learning can be used to adjust only a few layers of the deep learning model for the second data set.

[0372] Figure 32 is a flowchart of a method 3201 for machine learning training of a 12-lead ECG with a three-electrode device in accordance with some embodiments of the present application. The method 3201 can be performed by processing logic that comprises hardware (e.g., circuitry, dedicated logic, programmable logic, microcode, etc.), software (e.g., instructions run on a processing device to simulate hardware), or a combination thereof. In one embodiment, the processing logic is implemented in a target device, such as the target device 1000 of FIG. 10. Figures 1 to 30The processing logic corresponding to one or more components or methods can perform one or more of the following operations. For example, in one embodiment, the processing logic of the processing device 1110 performs the following operations with respect to Figures 1 to 30 the various components and operations thereof. In another embodiment, any other suitable processing device can perform the described operations.

[0373] Referring to Figure 32 , at block 3207, the processing logic can train a machine learning model using 12-lead ECG data corresponding to a population of individuals. In another embodiment, the model can be trained using data from a single individual (e.g., the user for whom the ECG is to be determined). In one example, the machine learning model can be trained to correlate measured data from leads I, II, and III with measured 12-lead data. Once trained, the machine learning model can accurately predict the leads of a 12-lead ECG using only data from leads I, II, and III.

[0374] Optionally, at block 3203, the processing logic can pre-process the 12-lead ECG data prior to using the 12-lead ECG data to train the machine learning model to categorize the data based on at least one of height, gender, weight, and nationality. By pre-processing in this manner, the model can be more efficiently trained to provide more accurate results specific to the user for whom the 12-lead ECG is to be determined. For example, the processing logic can categorize the 12-lead ECG data based on characteristics of the individual (3205). In one embodiment, if the individual is identified as 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 particular nationality, the data can be pre-processed to include only that particular nationality. Training the model using such pre-processed data can allow the model to be trained more quickly and provide more accurate results than would be possible without such pre-processing.

[0375] In one embodiment, features of the 12-lead data can be selected, extracted, and labeled 12 to predict 12-lead ECGs from three leads in real-time, for example, by performing one or more machine learning operations. Such operations can be selected from operations that rank the feature(s), classify the feature(s), label the feature(s), predict the feature(s), and cluster the feature(s). Alternatively or in combination, the extracted features can be labeled and saved for offline training of a machine learning algorithm or set of machine learning operations. For example, the operations can be selected from any of the above operations. Any number of machine learning algorithms or methods can be trained to predict 12-lead ECGs from three leads. These can include decision tree learning, such as with random forests, 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, among others.

[0376] Machine learning-based algorithms or operations for predicting 12-lead ECGs 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) set up on a user’s computing device. The interaction or communication can be through an application program interface (API). For example, the API can provide access to machine learning operations for ranking, clustering, classifying, and predicting 12-lead ECGs from three leads.

[0377] Machine learning-based algorithms or operations provided through a remote server and / or on a local application on a local computing device can operate on, learn from, and make analytical predictions on 12-lead and / or three-lead data, for example, from a population of users.

[0378] The comparisons and analyses described herein can be used to draw conclusions and insights about a patient’s health status, including potential health problems that the patient can experience at the time of measurement or at a future time. The conclusions and determinations can predict future health conditions or diagnose conditions that the patient already has. The conclusions and determinations can also include insights about the effectiveness or risks associated with medications or drugs that the patient can be taking, has taken, or can consider taking in the future. Additionally, the comparisons and analyses can be used to determine behaviors and activities that can reduce or increase the risk of adverse events. Based on the comparisons and analyses described herein, the ECG data can be classified according to a risk level of adverse events. For example, the ECG data can be classified as normal, low risk, moderate risk, high risk, and / or abnormal. Normal and abnormal designate that a healthcare professional can need to evaluate, diagnose, and / or confirm.

[0379] Diagnoses and determinations of abnormalities, adverse events, or disease states by physicians and other healthcare professionals can be communicated to the server and database for tagging and association with corresponding ECG data. Diagnoses and determinations can be based on analysis of ECG data, or can be determined using other testing or examination procedures. Professional diagnoses and determinations can be extracted from a patient’s electronic health record, can be input into the system by the patient, or can be input into the system by a medical professional. The conclusions and determinations of the system can be compared to actual diagnoses and determinations from medical professionals to validate and / or refine machine learning algorithms used by the system. The time of occurrence and duration of an abnormality, adverse event, or disease state can also be included in the database, such that ECG data corresponding to the occurrence and / or ECG data before and / or after the abnormality, adverse event, or disease state can be linked together and analyzed. The length of time before or after an abnormality can be pre-determined, and can be up to 1 to 30 days, or greater than 1 to 12 months. Analysis of the time before an abnormality can allow the system to identify patterns or correlations of various ECG features before the occurrence of an abnormality, adverse event, or disease state, thereby providing early detection or warning of the abnormality, adverse event, or disease state. Analysis of the time after an abnormality can provide information related to treatment efficacy and / or provide information to the patient or physician related to disease progression, such as whether the patient’s condition has improved, worsened, or remained the same. Diagnoses and determinations can also be used for indexing by, for example, including them in metadata associated with corresponding ECG data.

[0380] As described herein, various parameters can be included in the database with the ECG data. These parameters can include the patient’s age, sex, weight, blood pressure, medications, behaviors, habits, activities, food consumption, beverage consumption, medications, medical history, and other factors that can affect the patient’s ECG signal. Additional parameters can or can not be used for comparison of ECG signals over time and environment.

[0381] Conclusions, determinations, and / or insights of the patient’s health generated by the system can be communicated to the patient directly or via the patient’s caregiver (physician or other healthcare professional). For example, an email or text message generated automatically by the system can be sent to the patient. The email or text message can be a notification instructing the patient to log into a secure site to retrieve the full conclusion, determination, or insight, or the email or text message can include the conclusion, determination, or insight. Alternatively or additionally, the email or text message can be sent to the patient’s caregiver. The notification can also be provided via an application on a smartphone, tablet, laptop, desktop, or other computing device.

[0382] As described herein, the system can identify behaviors, habits, activities, foods, beverages, medications, and pharmaceuticals, etc. that are associated with abnormal ECG readings for a patient. In addition to notifying the patient of these associations, the system can also provide the patient with indications or recommendations to avoid these behaviors, habits, activities, foods, beverages, medications, and pharmaceuticals, etc. that are associated with abnormal ECG readings for the patient. Similarly, the system can identify behaviors, habits, activities, foods, beverages, medications, and pharmaceuticals, etc. that are associated with normal or improved ECG readings, and can indicate or recommend that the patient engage in these behaviors, habits, and activities and / or consume these foods, beverages, medications, and pharmaceuticals. The patient can avoid future healthcare issues by modifying their behaviors, habits, or by taking any course of action, including but not limited to taking medication, pharmaceuticals, or adhering to a diet or exercise plan, that the system indicates or recommends, which can be a predetermined course of action independent of any analysis of ECG data that is recommended by the system and / or can also be a course of action that arises from insights learned by the system and methods as described herein. Additionally, the insights of the system can relate to general health and / or mental health.

[0383] 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 ordered 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, which can be selected according to any of the features, parameters, or criteria described herein. When analyzing data from a single patient, it can be desirable to reduce and / or correct for intra-individual variability of the ECG data, such that a comparison of one set of ECG data taken at one particular time to another set of ECG data taken 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 conditions (i.e., dry, sweaty, conductive gel applied or not applied), etc. As described above, consistent lead and electrode placement can help reduce variability in ECG readings. The system can also retrieve ECG data for a patient taken under similar circumstances, and can analyze this subset of ECG data.

[0384] Cross Reference to Related Applications

[0385] 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.

Claims

1. An apparatus comprising: an electrocardiogram device having a first electrode assembly, a second electrode assembly, and a third electrode assembly, the first, second, and third electrode assemblies having a first, second, and third electrode, respectively, adapted to measure a first, second, and third electrical signal of an individual; and a processing device to: determine lead I from the first and second electrical signals, determine lead II from the second and third electrical signals, generate lead III using (lead III = lead II - lead I), determine leads aVR, aVL, aVF, VI, V2, V3, V4, V5, and V6 based on leads I, II, and III using a machine learning model trained with measured 12-lead ECG data, and provide the leads, i.e., leads I, II, III, aVR, aVL, aVF, VI, V2, V3, V4, V5, and V6, for display on a client device. The lead II is determined sequentially with the lead I.

2. The apparatus of claim 1, wherein, The processing device is further to time align the lead I and the lead II.

3. The apparatus of claim 2, wherein, The lead II is determined simultaneously with the lead I.

4. The apparatus of claim 1, wherein, 5. The apparatus of claim 1, the processing device is further to train the machine learning model using 12-lead ECG data corresponding to a population of individuals.

6. The apparatus of claim 5, the processing device is further to preprocess the 12-lead ECG data to classify the 12-lead ECG data based on at least one of height, gender, weight, and nationality, prior to using the 12-lead ECG data to train the machine learning model.

7. The apparatus of claim 6, the processing device is further to characterize the 12-lead ECG data based on characteristics of the individual.

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

9. A method for generating a 12-lead electrocardiogram, the method comprising: determining lead I from a first electrical signal of a first electrode and a second electrical signal of a second electrode; determining lead II from the second electrical signal and a third electrical signal from a third electrode; generating lead III using (lead III = lead II - lead I); determining leads aVR, aVL, and aVF from leads I and II; determining leads VI, V2, V3, V4, V5, and V6 based on leads I, II, and III using a machine learning model trained with measured 12-lead ECG data by a processing device; and providing the leads, i.e., leads I, II, III, aVR, aVL, aVF, VI, V2, V3, V4, V5, and V6, for display on a client device. The lead II is determined sequentially with the lead I.

10. The method of claim 9, wherein, The lead I and the lead II are time aligned.

11. The method of claim 10, further comprising: The lead II is determined simultaneously with the lead I.

12. The method of claim 9, wherein, ​ 13. The method of claim 9, further comprising: training the machine learning model using 12-lead ECG data corresponding to a population of individuals.

14. The method of claim 13, further comprising: pre-processing the 12-lead ECG data prior to using the 12-lead ECG data for training the machine learning model to classify the 12-lead ECG data based on at least one of height, gender, weight, and nationality.

15. The method of claim 14, further comprising: classifying the 12-lead ECG data based on characteristics of the individual.

16. The method of claim 9, further comprising: training the machine learning model using only 12-lead ECG data corresponding to an individual.

17. A non-transitory computer-readable storage medium storing instructions that, when executed by a processing device, cause the processing device to: determine lead I from a first electrical signal of a first electrode and a second electrical signal of a second electrode; determine lead II from the second electrical signal and a third electrical signal from a third electrode; determine V lead from a fourth electrical signal; determine leads aVR, aVL, and aVF from leads I and II; generate lead III using (lead III = lead II - lead I); determine leads and remaining V leads based on lead I, lead II, lead III, and V lead using, by the processing device, a machine learning model trained using measured 12-lead ECG data; and provide leads, namely lead I, lead II, lead III, aVR, aVL, aVF, VI, V2, V3, V4, V5, and V6, for display on a client device.

18. The non-transitory computer-readable storage medium of claim 17, wherein, lead II is determined simultaneously with lead I.

19. The non-transitory computer-readable storage medium of claim 17, the processing device is further to train the machine learning model using 12-lead ECG data corresponding to a population of individuals.

20. The non-transitory computer-readable storage medium of claim 19, wherein, the V lead is at least one of lead V2 and lead V5.

Images