Twelve-lead electrocardiogram using a 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

(19) State Intellectual Property Office (12) Invention Patent Application (10) Application Publication Number (43) Application Publication Date (21) Application Number 202511063209.7 (22) Application Date 2020.12.10 (30) Priority Data 62 / 946,331 2019.12.10 US 17 / 116,905 2020.12.09 US (62) Divisional Application Data 202080095935.6 2020.12.10 (71) Applicant Allifk Company Address USA (72) Inventors David E. Albert B. Sachs Wilming Jim Norman Barnett J.Q. Xue (74) Patent Agency Beijing Linda Liu Intellectual Property Agency (General Partnership) 11277 Patent Attorneys Wang Xiaoxiang Song Xiaowen (51) Int.Cl. A61B 5 / 327(2021.01) A61B 5 / 28(2021.01) (54) Invention Title: 12-Lead Electrocardiogram Using a Three-Electrode Device (57) Abstract: An electrocardiogram device comprising 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. The device also includes a processing unit for: determining lead I based on a first electrical signal and a second electrical signal; determining lead II based on a second electrical signal and a third electrical signal; generating lead III using (lead III = lead II - lead I); determining leads aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 based on leads I, lead II, and lead III using a machine learning model trained using measured 12-lead ECG data; and providing leads I, lead II, lead III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 for display on a client device. Claims (2 pages), Description (51 pages), Drawings (39 pages), CN 120899266 A, 2025.11.07, CN 1 20 89 92 66 A 1. An apparatus comprising: an electrocardiogram (ECG) 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 each having a first electrode, a second electrode, and a third electrode adapted to measure a first electrical signal, a second electrical signal, and a third electrical signal of an individual; and a processing device for: determining lead I based on the first electrical signal and the second electrical signal, and determining lead II based on the second electrical signal and the third electrical signal.Lead III is generated using (Lead III = Lead II - Lead I). A machine learning model trained using measured 12-lead ECG data is used to determine leads aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 based on Lead I, Lead II, and Lead III, and leads I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 are provided for display on a client device. 2. The device of claim 1, wherein Lead II and Lead I are determined sequentially. 3. The device of claim 2, wherein the processing means is further configured to time-align Lead I and Lead II. 4. The device of claim 1, wherein Lead II and Lead I are determined simultaneously. 5. The device of claim 1, wherein the processing means is further configured to train the machine learning model using 12-lead ECG data corresponding to an individual population. 6. The device of claim 5, wherein the processing apparatus is further configured to preprocess the 12-lead ECG data to classify the 12-lead ECG data based on at least one of height, sex, weight, and nationality before using the 12-lead ECG data to train the machine learning model. 7. The device of claim 6, wherein the processing apparatus is further configured to characterize the 12-lead ECG data based on the characteristics of the individual. 8. The device of claim 1, wherein the processing apparatus is further configured to train the machine learning model using only the 12-lead ECG data corresponding to the individual. 9. A method for generating a 12-lead electrocardiogram, the method comprising: determining lead I based on a first electrical signal from a first electrode and a second electrical signal from a second electrode; determining lead II based on 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 based on leads I and II; determining leads V1, V2, V3, V4, V5, and V6 based on leads I, lead II, and lead III using a machine learning model trained on measured 12-lead ECG data via a processing device; and providing leads I, lead II, lead III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 for display on a client device. 10. The method of claim 9, wherein lead II and lead I are determined sequentially. 11. The method of claim 10, further comprising: timing lead I and lead II. 12. The method of claim 9, wherein lead II and lead I are determined simultaneously. 13. The method of claim 9, further comprising: training using 12-lead ECG data corresponding to an individual population.Training the machine learning model. Claims 1 / 2 Page 2 CN 120899266 A 14. The method of claim 13, further comprising: preprocessing the 12-lead ECG data to classify the 12-lead ECG data based on at least one of height, sex, weight, and nationality before using the 12-lead ECG data to train the machine learning model. 15. The method of claim 14, further comprising: classifying the 12-lead ECG data based on the characteristics of the individual. 16. The method of claim 9, further comprising: training the machine learning model using only the 12-lead ECG data corresponding to the 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 based on a first electrical signal from a first electrode and a second electrical signal from a second electrode; determine lead II based on the second electrical signal and a third electrical signal from a third electrode; determine lead V based on a fourth electrical signal; determine leads aVR, aVL, and aVF based on leads I and II; generate lead III using (lead III = lead II - lead I); determine leads and the remaining leads V based on leads I, II, III, and leads V using a machine learning model trained with measured 12-lead ECG data; and provide leads I, II, III, aVR, aVL, aVF, V1, 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 and lead I are determined simultaneously. 19. The non-transitory computer-readable storage medium of claim 17, wherein the processing apparatus is further configured to train the machine learning model using 12-lead ECG data corresponding to an individual group. 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. Claims 2 / 2 Page 3 CN 120899266 A 12-lead electrocardiogram using a three-electrode device

[0001] (This application is a divisional application of the application filed on December 10, 2020, with application number 2020800959356 and entitled "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 devices for utilizing personal computers, laptop computers, tablet computers, etc.Such devices, systems, and methods utilize computing devices such as computers, smartphones, or wearable computing devices to provide electrocardiogram (ECG), heart rate, and arrhythmia monitoring. Background Art

[0003] Cardiovascular disease is a leading cause of death worldwide. In 2008, 30% of all global deaths were attributable to cardiovascular disease. It is also estimated that by 2030, more than 23 million people will die from cardiovascular disease each year. Cardiovascular disease is prevalent in both high- and low-income populations.

[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 or even sudden cardiac death. In fact, arrhythmias are one of the most common causes of death when going to the hospital.

[0005] The present invention relates to a device comprising: an electrocardiogram (ECG) apparatus 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 respectively having a first electrode, a second electrode, and a third electrode suitable for measuring a first electrical signal, a second electrical signal, and a third electrical signal of an individual; and a processing device for: determining lead I based on the first electrical signal and the second electrical signal; determining lead II based on the second electrical signal and the third electrical signal; generating lead III using (lead III = lead II - lead I); determining leads aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 based on leads I, lead II, and lead III using a machine learning model trained using measured 12-lead ECG data; and providing leads I, lead II, and lead III. Leads III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 are provided for display on a client device. Brief Description of the Drawings

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

[0007] FIG1 shows a schematic diagram of a system for measuring and monitoring biometrics or physiological parameters according to many embodiments;

[0008] FIGS. 2A to 2K show a biometrics or physiological parameter measurement and monitoring system including a smartphone and a protective smartphone casing according to many embodiments;

[0009] FIGS. 3A to 3F show a biometrics or physiological parameter measurement and monitoring system including a tablet computer and a protective tablet computer casing according to many embodiments;

[0010] FIGS. 4A to 4C show a biometrics system including a keyboard and keyboard accessories for a computing device according to many embodiments.Or physiological parameter measurement and monitoring system;

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

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

[0013] Figure 7 is an illustration of the body, showing an example of electrode placement for performing a standard 12-lead ECG;

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

[0015] Figure 9A shows a modified front view of the device as described herein (wherein, in this example, a wireless mobile telecommunications device is shown inserted into a device configured as a housing);

[0016] Figures 9B, 9C, and 9D show a left side view, a rear view, and a right side view of the device of Figure 9A, respectively;

[0017] Figure 10A is another modified front view of the device as described herein, configured as shown as an empty housing. However, it is suitable for maintaining a mobile telecommunications device;

[0018] Figures 10B to 10D respectively show a left side view, a rear view, and a right side view of the device of Figure 4A (in this example, the leg (first) electrode is on the left side of the housing);

[0019] Figures 11A to 11C respectively illustrate another variation of the device as described herein from a left side view, a rear view, and a right side view (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 respectively illustrate another variation of the device as described herein from a left side view, a rear view, and a right side view (in this example, the leg (first) electrode is on the rear surface, adjacent to the left side);

[0021] Figures 13A to 13C respectively illustrate another variation of the device as described herein from a left side view, a rear view, and a right side view (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 illustrate another variation of the device as described herein from left, rear, and right views, respectively (in this example, the left (first) electrode is on the left side of the housing, and the second and third electrodes are part of an electrode unit held on the rear surface by the housing);

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

[0024] Figures 16A to 16B illustrate another variation of the device as described herein from left, rear, and right views, respectively (in this example, the leg (first) electrode is on a cord that can extend from the body of the device to attach to the leg);

[0025] Figure 17 illustrates a modified application of the device described herein for detecting ECG, held against a patient's leg such 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 a diagram of human hearing range and thresholds from http: / / en.labs.wikimedia.org / wiki / Acoustics;

[0027] Figure 19 is a diagram of age-related hearing loss from www.neuroreille.com / promenade / english / audiometry / audiometry.htm;

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

[0029] Figure 21A is a schematic diagram of a system configured to transmit digital data encoded with one or more biological parameters ultrasonically to a telecommunications device such as a smartphone; Specification 2 / 51 pages 5 CN 120899266 A

[0030] Figure 21B is a schematic diagram of a system including a medical sensing device configured to transmit data encoded with one or more bio-parameters using ultrasound to a telecommunications device such as a smartphone;

[0031] Figure 21C is a schematic diagram of a system including a medical sensing device configured to transmit and receive data encoded with one or more bio-parameters (e.g., ECG data) using ultrasound to a telecommunications device such as a smartphone;

[0032] Figure 22 illustrates a variation of a digital signal that has been frequency-key-shift encoded in the ultrasound range as described;

[0033] Figure 23 is an exemplary flowchart illustrating a method of transmitting encoded data as an ultrasound signal;

[0034] Figures 24A to 24E are exemplary flowcharts of a method for transmitting signals (e.g., packet transmission) as ultrasound signals;

[0035] Figure 25 shows an example flowchart of a demodulator and packet decoder used by a receiver configured to receive and decode data transmitted using ultrasound as discussed herein;

[0036] Figure 26A illustrates an exemplary format of a hybrid digital and analog ultrasonic data format;

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

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

[0039] Figures 28A and 28B illustrate a variation of a wristband device for sensing one or more bioparameters and for wirelessly transmitting one or more bioparameters to a mobile communication / computing device at very low power (Figure 28A shows an external view of the wristband, while Figure 28B illustrates a schematic diagram of the internal area including various modules for sensing, powering, and transmitting ultrasonic signals, and many of these elements are optional);

[0040] Figure 29 shows a variation of a wristband of a watch configured for detecting ECG signals;

[0041] Figure 30 shows the wristband of Figure 29 communicating (via ultrasound) with a mobile telecommunications device to transmit ECG information;

[0042] Figure 31 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 is a flowchart of a method for machine learning training of 12-lead ECG using a three-electrode device according to some embodiments of the present invention. Detailed Description

[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 arrhythmia. In A-fib, electrical conduction through the ventricles of the heart is irregular and disordered. Although A-fib may not cause symptoms, it is commonly associated with palpitations, shortness of breath, syncope, chest pain, or congestive heart failure, and also increases the risk of stroke. A-fib is usually diagnosed by capturing an electrocardiogram (ECG) of the subject. To treat A-fib, patients may take medications to slow their heart rate or alter their heart rhythm. Patients may also take anticoagulants to prevent stroke, or may even undergo surgical interventions including cardiac ablation to treat A-fib.

[0048] Typically, long-term monitoring of patients with arrhythmias or A-fib is necessary to manage the condition. For example, patients may be advised to…Holter monitors or other dynamic electrocardiogram (ECG) devices are provided 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 the diagnosis and treatment of both. An electrocardiogram (ECG) can be recorded or captured using electrodes placed at multiple locations on a patient's skin. The electrical signals recorded between pairs of electrodes are called leads. Different numbers of leads can be used to capture an ECG, and various combinations of electrodes can be used to form a variety of leads. Examples of leads used to capture an ECG are 1, 3, 5, and 12 leads. For a 12-lead ECG, 10 electrodes can be used, with six electrodes on the chest and one each on the patient's arms and legs.

[0050] Different “standard” configurations exist for electrode placement that can be used to place electrodes on a patient. For example, arm and leg electrodes may be placed closer to the chest or closer to the end of the arm / leg. Variations in electrode placement on the arms and legs can affect the ECG and make it more difficult to compare with a standard ECG.

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

[0052] In another embodiment, three electrodes (e.g., utilizing a device comprising three electrodes) may be used to generate a 12-lead ECG. For example, in one embodiment, a device with three electrodes as described herein may be used to simultaneously determine lead I (e.g., the voltage between the left leg and right arm) with lead II (e.g., the voltage between the left leg and right arm) and simultaneously determine lead I with lead V2 or another of the chest leads (such as V5, etc.). In other embodiments, any other combination of leads is permissible. The processing logic can then time-align the two sets of records using lead 1 or another lead shared by the measurements, allowing comparison of the two sets of measurements within the same simulated time period.

[0053] 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 networks, deep learning techniques, etc.) to perform this transformation. The machine learning model can be trained using 12-lead ECG data corresponding to an individual population. This data can be preprocessed to filter the data in a way suitable for the application before being input into the machine learning model. For example, the data is preprocessed before being input into the machine learning model.Before training one or more machine learning models, the models can be categorized based on height, sex, weight, nationality, etc., allowing for fine-tuning of the resulting models for specific types of individuals. In another embodiment, the machine learning model can be further trained based on the user's own ECG data to further fine-tune and personalize the model to reduce any residual synthesis error.

[0054] In one embodiment, using the machine learning techniques described herein, a complete 12-lead ECG can be generated using only three electrodes with a single shape 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] Figures 7 and 8 illustrate the placement of six electrodes on the chest (labeled V1, V2, V3, V4, V5, and V6). V1 is placed in the fourth intercostal space, for example, between ribs 4 and 5, just to the right of the sternum. V2 is placed in the fourth intercostal space, for example, between ribs 4 and 5, just to the left of the sternum. V3 is placed between electrodes V2 and V4. V4 is placed in the fifth intercostal space between ribs 5 and 6 in the midclavicular line. V5 is placed horizontally in the left anterior axillary line, flush with V4. V6 is placed horizontally in the midaxillary line, flush with V4 and V5.

[0056] Lead I is typically the voltage between the left arm (LA) and the right arm (RA), for example, I = LA - RA. Lead II is typically the voltage between the left leg (LL) and the right arm (RA), for example, II = LL - RA. Lead III is typically the voltage between the left leg (LL) and the left arm (LA), for example, III = LL - LA. The Wilson central terminal (WCT or VW) can be calculated by (RA + LA + LL) / 3. Considering that both leads I and II are recorded with reference to RA, such that the voltage of RA can be considered zero, WCT (VW) can be calculated as lead I + lead II / 3.

[0057] The compression limb leads can also be determined based on RA, RL, LL, and LA. The compression vector right (aVR) equals RA - (LA + LL) / 2 or - (I + II) / 2. The compression vector left (aVL) equals LA - (RA + LL) / 2 or I - II / 2. The compression vector left (aVF) equals LL - (RA + LA) / 2 or II - I / 2.

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

[0059] However, current dynamic electrocardiogram devices such as Holter monitors are often bulky and difficult for subjects to administer without the assistance of a medical professional. For example, the use of a Holter monitor requires...Patients wear bulky devices on their chests with multiple electrodes precisely placed at precise locations on their chests. These requirements can hinder the subject's activities, including their natural movement, bathing, and showering. Once a fully exposed ECG is generated, it is sent to the patient's doctor, who then analyzes the ECG and provides a diagnosis and other recommendations. Currently, this process typically must be conducted through hospital administrators and health management organizations, and many patients do not have convenient access to feedback.

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

[0061] Wearable monitors used to detect one or more biometric parameters (including subject movement, heart rate, temperature, ECG, etc.) typically must communicate wirelessly with a monitoring, analysis, or recording station (“monitoring station”). Typically, the transmission of information has been done via short-wavelength radio transmission (e.g., “Bluetooth”). It is worth noting that although some embodiments of ultrasonic communication have been described, it is conceivable that Bluetooth communication is equally (if not more) applicable to the described techniques, and that ultrasonic is presented only as a non-limiting example of any number of other suitable communication technologies. It is expected that those skilled in the art will recognize this.

[0062] In some cases where it is desirable for the device to be lightweight so that it can be comfortably worn during normal daily activities or exercise, many manufacturers have chosen to record data rather than transmit it, and to periodically download data by directly connecting to a monitoring station. It would be advantageous to provide a monitoring device that can be worn by the subject on the wrist (e.g., a wristband) or on other body areas capable of reliably and low-energy wireless transmission of data.

[0063] For example, cardiac monitoring devices such as those described in U.S. Patent Nos. 4,221,223, 4,295,472, and 4,230,127 describe a wristwatch-sized wearable monitor from which ECG signals can be detected from a patient wearing the device; these signals can be displayed on the device. These signals are not transmitted. Other similar devices are described in U.S. Patent No. 4,938,228. Improvements to the device are described in U.S. Patents 5,351,695, 5,333,616, 5,317,269, and 5,289,824 (all belonging to Mils), which include an integrated hearing aid speaker for using audible sounds (e.g., between 1 kHz and 3 kHz) on the voice channel of a telephone.ECG signals are transmitted over telephone lines. ECG signals are typically digitized and frequency modulated (e.g., as frequency shift keying signals). Unfortunately, as described on page 5 / 51 of the specification 8 CN 120899266 A, such a device does generate audible signals with noise, requires a large amount of power to generate and transmit, and cannot perform bidirectional communication, particularly not with mobile telecommunications devices.

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

[0065] Ultrasonic transmission has many similarities to electrical transmission, but there are also substantial differences, including those previously considered disadvantages. Furthermore, although techniques such as frequency shift keying for digitized information are known, it is difficult and impractical to implement such techniques on a timescale for medical (e.g., ECG) monitoring. In particular, the transmission of ultrasound data has been limited to some extent in terms of information content. For example, digital encoding of information via ultrasound is limited in terms of the amount and content of the transmitted information. There are no standards for the transmission or encoding of ultrasound. In addition, such ultrasound signals are not conventionally encrypted.

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

[0067] This document describes methods, apparatuses, and systems for receiving and transmitting information (including, but not limited to, digital health information) encoded into ultrasonic signals by an application device using (or adapted to use) one or more widely available telecommunications devices (including mobile telecommunications devices such as smartphones, tablets, laptops, or desktop computers), which can be heard by the telecommunications device and then stored, transmitted, and / or analyzed by the telecommunications device. In particular, this document describes methods, apparatuses, and systems for encoding such information such that it can be deciphered only by a telecommunications device provided with a key. Systems, apparatuses, and methods (including executable logic) may include techniques for easily providing keys using a modality different from ultrasonic transmission (e.g., optical).

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

[0069] Therefore, 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 challenges described above.

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

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

[0072] Cardiac parameters may include heart rate, heart rate variability, blood pressure, blood pressure variability, arrhythmia, and electrocardiogram (SCG).One or more of SCG parameters, electrocardiogram (ECG), and ECG parameters. In many embodiments, cardiac parameters include electrocardiogram (ECG) or ECG parameters.

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

[0074] The sensor for measuring cardiac parameters may include a first electrode and a second electrode configured to generate a signal including cardiac parameters when in contact with a user. For example, the first electrode may be configured to contact the user's right arm, and the second electrode may be configured to contact the user's left arm to generate lead I ECG. Alternatively or in combination, the first electrode may be configured to contact the user's right arm, and the second electrode may be configured to contact the user's left leg to generate lead II ECG. Alternatively or in combination, the first electrode may be configured to contact the user's left arm, and the second electrode may be configured to contact the user's left leg to generate a lead IIIECG. The sensor may also include a third electrode for contact, configured to generate a signal including cardiac parameters upon contact with the user. The first, second, and third electrodes may, for example, be used simultaneously to generate one or more of a lead IECG, a lead IIECG, and a lead IIIECG. The first electrode may be configured to contact the user's right arm, the second electrode may be configured to contact the user's left arm, and the third electrode may be configured to contact the user's left leg.

[0075] The first application may also be configured to display the measured cardiac parameters, for example, on a display of a computing device. The cardiac parameters may be displayed in real time. The first application may also be configured to store the measured cardiac parameters in the memory of the computing device. The first application may also be configured to send the measured cardiac parameters to a remote computing device, such as a remote server. The remote computing device may store cardiac or other physiological parameter data and allow medical experts and other professionals to access this data for data analysis, interpretation, and / or diagnosis. Analysis and diagnosis can be sent back to the user via a remote computing device and the user's computing device, or via other channels such as email, text message, or other electronic alerts. Alternatively or in combination, one or more of a first application loaded onto the computing device, another application loaded onto a remote server, and another application used by a medical expert or professional can automatically generate such data analysis, interpretation, and / or diagnosis.

[0076] Manipulation of the second application can include typing on the keyboard of the second application, scrolling on the second application, and...One or more of the following applies: magnification or reduction in one application, or inputting data into another application in a different manner. By allowing a user to manipulate a second application loaded on a computing device while a first application measures and monitors the user's heart and other health parameters, embodiments of the 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 the computing device to check emails, browse the web, or operate a mobile application while the first application and the computing device are in the background measuring and / or monitoring the user's ECG or other heart and physiological parameters. Specification 7 / 51 pages 10 CN 120899266 A

[0077] An aspect of the invention also provides a method for measuring a user's heart parameters. A device including sensors for heart parameters can be coupled to a computing device. The user's heart parameters can be measured using the sensors. The measured heart parameters can be sent using the device to a first application loaded on the computing device. Heart parameters can be measured, and the first application can receive the sent measured heart parameters while the user manipulates the second application loaded on the computing device.

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

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

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

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

[0082] Manipulation of the second application may include one or more of typing on the 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. By allowing users to manipulate a second application loaded onto the computing device while the first application measures and monitors (one or more) of the user's cardiac and other health parameters, embodiments of the invention allow for user-friendly, convenient, and less invasive and destructive measurement and monitoring of cardiac and other health parameters. For example, a user can hold and normally operate the computing device to check emails, browse a web browser, or operate a mobile application while the first application and the computing device are in the background measuring and / or monitoring the user's ECG or other cardiac and physiological parameters. In some embodiments, if the health parameter sensor is incorrectly positioned, making it impossible or unusable to perform a correct measurement, the first application may cause the computing device to warn the user (i.e., a pop-up window may be shown in the second application, as described on page 8 / 51 of the specification, CN 120899266 A).

[0083] An aspect of the invention also provides a system for measuring a user's cardiac parameters. The system may include a cover configured to be removably attached to a portable computing device. The portable computing device may include a front, a back, and an edge between them. The cover may include a plurality of sensor electrodes configured to measure cardiac parameters.And when the cover is attached to a portable computing device, it is arranged on the edge of the portable computing device. In many embodiments, multiple sensor electrodes are arranged only on the edge of the portable computing device. The portable computing device may include a laptop computer, tablet computer, personal digital assistant (PDA), or smartphone.

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

[0085] Multiple sensor electrodes may include a first sensor electrode and a second sensor electrode. The first sensor electrode and the second sensor electrode may be configured to generate signals including cardiac parameters when in contact with a user's first limb and second limb, respectively. For example, the first electrode may be configured to contact the user's right arm, and the second electrode may be configured to contact the user's left arm to generate a lead I ECG. Alternatively or in combination, the first electrode may be configured to contact the user's right arm, and the second electrode may be configured to contact the user's left leg to generate a lead I IECG. Alternatively or in combination, the first electrode may be configured to contact the user's left arm, and the second electrode may be configured to contact the user's left leg to generate a lead III ECG. The plurality of sensor electrodes may also include a third sensor electrode configured to generate a signal including cardiac parameters upon contact with the user's third limb. Cardiac parameters may also be measured using the third electrode of the sensor, which is configured to generate a signal including cardiac parameters upon contact with the user. The first, second, and third electrodes may, for example, be used simultaneously to generate one or more of lead I, lead II, and lead III ECGs.

[0086] The system may also include a first application loaded onto a portable computing device. The first application may be configured to receive measured cardiac parameters from the plurality of sensor electrodes. The first application may receive the measured cardiac parameters while a second application is loaded onto the portable computing device and manipulated by the user. Manipulation of the second application may include one or more of typing on the keyboard of the second application, scrolling on the second application, zooming in or out in the second application, and otherwise inputting data into the second application. By allowing users to manipulate a second application loaded on a computing device while a first application measures and monitors a user's heart and other health parameters, 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 the computing device to check emails, browse a web browser, or operate a mobile application while the first application and the computing device are measuring and / or monitoring the user's ECG or other heart and physiological parameters in the background.

[0087] The first application can be configured to display the received cardiac parameters on the display of a 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 the memory of the portable computing device. The first application can also be configured to send the measured cardiac parameters to a remote computing device such as a remote server. The remote computing device can store cardiac or other physiological parameter data and allow medical experts and other professionals to access this data for data analysis, interpretation and / or diagnosis. The analysis and diagnosis can be sent back to the user via the remote computing device and the user's computing device or via other channels such as email, text message or other electronic alerts. Alternatively or in combination, one or more of the first application loaded on the computing device, another application loaded on the remote server and another application used by medical experts or professionals can automatically generate such data analysis, interpretation and / or diagnosis. Specification 9 / 51 pages 12 CN 120899266 A

[0088] An aspect of the invention also provides a method for measuring a user's cardiac parameters. A cover can be removably attached to a portable computing device. The portable computing device can include a front, a back, and an edge between them. The first and second electrodes of the cover can contact the user's first and second limbs, respectively, to generate signals including cardiac parameters. The first and second electrodes of the cover can be arranged on the edge of the portable computing device. In many embodiments, multiple sensor electrodes can be arranged only on the edge of the portable computing device. The portable computing device can include a laptop computer, tablet computer, personal digital assistant (PDA), or smartphone.

[0089] Cardiac parameters can include one or more of heart rate, heart rate variability, blood pressure, blood pressure variability, arrhythmia, electrocardiogram (SCG), SCG parameters, electrocardiogram (ECG), and ECG parameters. In many embodiments, cardiac parameters include electrocardiogram (ECG) or ECG parameters.

[0090] The third electrode can contact the user's third limb to generate signals including cardiac parameters. The first limb can include the right arm, the second limb can include the left arm, and the third limb can include the left leg. These three limbs can contact the first, second, and third electrodes simultaneously to simultaneously generate lead I ECG, lead II ECG, and lead III ECG. Alternatively, the first and second electrodes can be used to generate lead I ECG, lead II ECG, and lead III ECG. For example, the first electrode can be configured to contact the user's right arm, and the second electrode can be configured to contact the user's left arm to generate lead IECG. Alternatively or in combination, the first electrode can be configured to contact the user's right arm, and the second electrode can be configured to contact the user's left leg to generate lead II ECG.ECG. Alternatively or in combination, the first electrode may be configured to contact the user's left arm, and the second electrode may be configured to contact the user's left leg to generate a lead IIIECG.

[0091] Alternatively or in combination, the first application may be loaded onto a tablet computer or smartphone. The first application may be configured to receive measured cardiac parameters from multiple sensor electrodes. The first application may receive the measured cardiac parameters while the second application is loaded onto the computing device and manipulated by the user. Manipulation of the second application may include one or more of the following: typing on the keyboard of the second application, scrolling on the second application, zooming in or out in the second application, and otherwise inputting data into the second application. By allowing the user to manipulate the second application loaded onto 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 destructive measurement and monitoring of cardiac and other health parameters. For example, a user may hold and normally operate the computing device to check emails, browse a web browser, or operate a mobile application while the first application and the computing device are in the background measuring and / or monitoring the user's ECG or other cardiac and physiological parameters.

[0092] The received cardiac parameters can be displayed on the screen of a tablet computer or smartphone using a first application. The received cardiac parameters can be displayed in real time. The measured cardiac parameters can be stored in the memory of the computing device. The measured cardiac parameters can be sent 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 experts and other professionals to access this data for data analysis, interpretation, and / or diagnosis. The analysis and diagnosis can be sent back to the user via the remote computing device and the user's computing device or via other channels such as email, text message, or other electronic alerts. Alternatively or in combination, one or more of the first application loaded on the computing device, another application loaded on the remote server, and another application used by medical experts or professionals can automatically generate such data analysis, interpretation, and / or diagnosis.

[0093] An aspect of the invention also provides a system for measuring a user's cardiac parameters. The system may include sensor devices and applications. This device can be configured for coupling to a keyboard of a computing device, a steering wheel of a motor vehicle, or handlebars, seats, chairs, glasses, clothing, etc., of a bicycle, motorcycle, exercise equipment such as a treadmill, elliptical trainer, or weightlifting machine. The device may include sensors for measuring cardiac parameters. The device can be configured to sense cardiac parameters when the user touches, holds, or manipulates the keyboard of a computing device, the steering wheel of a motor vehicle, the handlebars of a bicycle, motorcycle, or exercise equipment. (See page 10 / 51, CN 120899266 A)The device receives measured cardiac parameters. Other methods and systems are also envisioned for convenient, non-invasive, and non-destructive measurement and monitoring of cardiac and other physiological parameters while the user is normally operating a computing or other device in contact with the user's body.

[0094] The invention also describes devices (including systems, software, and apparatuses) and methods (including methods for using these 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 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 for use with mobile telecommunications devices are described herein, enabling the mobile telecommunications device to receive biological signals measured directly from the patient. The device typically includes three or more electrodes (or exactly three electrodes) for receiving signals such as voltage or current from the patient's body. The device may also include a housing. The housing may be configured to hold or be directly connected to the mobile telecommunications device, such as a "shell". One or more electrodes may be directly positioned on the outer surface of the housing. The device may also include one or more transmitters for communicating sensing signals (including modified / processed versions of the sensing signals) from the electrodes to a mobile telecommunications device. The mobile telecommunications device may be connected to the housing, for example, within or near a casing formed by the housing. In some variations, the device may include one or more processing means for processing signals detected on the electrodes.

[0096] Any suitable transmitter (including wireless transmitters) may be used. In some variations, the wireless transmitter is an ultrasonic transmitter that can use inaudible ultrasound (e.g., >10kHz, >12kHz, >15kHz, >18kHz, >19kHz) 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 Publications US / 2011 / 0301435 and US / 2011 / 0301439, and by PCT Application Publication PCT / US2013 / 023370 (each of which is incorporated herein by reference in its entirety).

[0097] The devices described herein can be configured such that they can be held by a patient using both hands against the patient's legs (e.g., left or right leg) to measure six “leads” (leads I-III and compression leads aVR, aVL, aVF) from the patient. In some variations, the device can be configured such that the patient holds (encircles) the mobile telecommunications device with both hands.While the device is held against the leg (right or left) to record isolated signals from the right arm, left arm, and right or left leg, the view of the mobile telecommunications device can be easily viewed. This allows the patient to receive immediate visual feedback from the device during measurement, including (using the mobile telecommunications device screen or audio output) guidance to adjust or correct electrode contact or position, and / or display of one or more ECG signals. Therefore, the device can be configured as described herein to allow easy holding of the device 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 view of the mobile telecommunications device coupled to the device.

[0098] Typically, the patient (as used herein) can be human or non-human, including but not limited to animals (dogs, cats, horses, etc.). Therefore, 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 iPhone™ or Droid™, etc.). A mobile telecommunications device can generally include a processing device or other computing module / device capable of running software or hardware, etc., including machine-readable code configured to operate the device to receive and / or send information from the device described herein. Such code may be provided with the described device or separately from the described device. A mobile telecommunications device can refer to (and include) a telephone or cellular phone, a mobile phone, a smartphone, a handheld computer, a tablet computer, or a wearable computer, etc. The code may be referred to as software specification 11 / 51 pages 14 CN 120899266 A or application software (“app” or “application”) and may be downloaded to the mobile telecommunications device from a remote location.

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

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

[0102] In variations, the housing may include one or more attachment areas for one or more electrodes. For example, the housing may include an opening on the back for connection to an electrode unit that can be used with housings of different configurations (e.g., for mounting mobile telecommunications devices of different sizes). All three electrodes may be part of the same electrode unit, or multiple electrode units may be used. The electrode unit may include additional hardware such as the processing device mentioned above, and may also include a power supply or other electronic components.

[0103] The second and third electrodes are typically configured such that they can each be easily accessed by the patient's hand. For example, the second electrode may be positioned and sized such that the patient can touch the second electrode with his / her left hand while the patient is also touching the third electrode of appropriate shape and size with his / her right hand. For example, in some variations, the second and third electrodes are entirely on the outer rear surface. The second electrode may (relative to a mobile telecommunications device) be on the upper / left half of the back of the housing, while the third electrode is located on the lower / right half of the back of the housing. The second and third electrodes may be separated by a largeSmall and / or shaped gaps are determined 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 conductive material (including metals, alloys, etc.) and can be sized such that they can be easily contacted by one or more fingers (or palms) of the patient holding the device. In some variations, the second and third electrodes are positioned symmetrically relative to each other with respect to the center of the outer rear surface. Specification 12 / 51 pages 15 CN 120899266 A

[0105] The first electrode can be configured such that the first electrode can be easily held against the patient's leg 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 located entirely on the side of the housing (e.g., on one of at least two outer surfaces). Alternatively, the first electrode can be located on the rear surface of the housing but extends along the edge such that the first electrode can be held against the leg when the edge of the housing is held against the leg. Therefore, the first electrode may be on the rear surface, but adjacent to or immediately adjacent to the side surfaces (at least one of the two outer surfaces). In some variations, the first electrode bends laterally from the rear surface of the housing across the edge of the housing (e.g., along the edge of the housing). Thus, the first electrode may extend across the edge between one of the outer surfaces and the outer rear surface. Any of these configurations allows the housing of the mobile telecommunications device to be held at an angle relative to the patient's leg, allowing the patient to maintain good contact with the leg while still holding the housing with both hands, contacting the second and third electrodes, and viewing the image of the mobile telecommunications device.

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

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

[0108] Typically, the device may be configured such that when the device is placed downwards on a worktable with the electrodes (first electrode and / or second and third electrodes) facing the worktable, the electrodes do not contact the worktable surface. This allows for the absence of electrical contact.The device is placed face down on a metal surface where a conductive path is created between the electrodes, potentially resulting in discharge (and / or power consumption from the device), as is often found in hospitals or other medical settings. In some variations, the electrodes are recessed relative to the outer rear surface. For example, the electrodes may be recessed within the material forming the housing. Alternatively or additionally, the housing may include one or more protrusions that the housing can rest against when the rear surface is face down, thereby preventing one or more electrodes from contacting the surface. For example, the outer rear surface of the housing may include one or more "spacers" configured such that a portion of the outer rear surface extends relative to the outer contact surfaces of the first and second surfaces, such that the outer contact surfaces are recessed relative to the outer surface of one or more spacers. Typically, a spacer may refer to a protrusion whose height from the rear surface relative to the rear surface of the device is greater than the height of (one or more) electrodes. For example, a spacer may be a bump, island, strip, sheet, pull tab, etc., extending from the rear surface (in some variations, around the electrodes (e.g., completely or partially surrounding the electrodes)).

[0109] Typically, the electrodes can have sufficient surface area to easily and reliably contact the patient's hand and / or leg. The first (leg) electrode can have a different shape or size than the second and third electrodes. In some variations, the surface areas of the three electrodes are approximately the same. In some variations, the surface area of ​​the second or third (reference) electrode is larger than that of the other electrodes.

[0110] As described above, any device described herein can include a transmitter for communicating with a wireless telecommunications device. The transmitter can typically be wireless, or the transmitter can be directly connected (inserted) to a wireless telecommunications device. Electromagnetic transmitters (including near-field transmitters, radio (RF) transmitters, etc.), optical transmitters, or any other type of transmission can be used. In particular, an ultrasound transmitter that can be integrated into a device is described herein.

[0111] For example, this document describes an electrocardiogram (ECG) detection device for use with a wireless telecommunications device, comprising, as described on pages 13 / 51 of CN 120899266 A: a housing configured to be mounted on a telecommunications device, the housing having an outer rear surface, at least two outer surfaces perpendicular to the rear surface, and a front region through which an image of the telecommunications device held within the housing can be viewed; a first electrode on or adjacent to one of the at least two outer surfaces; a second electrode on the outer rear surface having an outer contact surface; a third electrode on the outer rear surface having an outer contact surface; and an ultrasonic transmitter configured to transmit signals sensed from the first, second, and third electrodes to the wireless telecommunications device using ultrasonic waves, wherein the outer contact surfaces of the second and third electrodes are recessed relative to at least a portion of the outer rear surface, such that...When the device is placed on a workbench surface with its outer rear surface facing the workbench surface, the outer contact surfaces of the second and third electrodes do not contact the workbench surface.

[0112] This document also describes methods of using any of the described devices. For example, this document describes a method of generating an electrocardiogram (ECG) from a patient using a handheld wireless telecommunications device housing having three electrodes on its outer surface, the method comprising: instructing the patient to hold a first electrode extending along the side of the housing against their leg while touching a second electrode on the back of the housing with their right hand and a third electrode on the back of the housing with their left hand, such that the patient contacts no more than three electrodes on the housing; detecting a first lead signal (lead I) of the ECG between the third electrode and the second electrode; detecting a second lead signal (lead II) of the ECG between the second electrode and the first electrode; and detecting a third lead signal (lead III) of the ECG between the first electrode and the third electrode.

[0113] This document also describes a method for generating an electrocardiogram (ECG) from a patient using a handheld wireless telecommunications device housing having three electrodes on its outer surface. The method includes: instructing the patient to hold a first electrode of the housing against their leg while touching a second electrode with their right hand and a third electrode with their left hand, such that the patient contacts no more than three electrodes on the housing; detecting a first lead signal (lead I) of the ECG between the third electrode and the second electrode; detecting a second lead signal (lead II) of the ECG between the second electrode and the first electrode; detecting a third lead signal (lead III) of the ECG between the first electrode and the third electrode; and transmitting the lead signals from the housing to the telecommunications device using ultrasound.

[0114] An aspect of the invention also provides an electrocardiogram (ECG) detection device for use with a wireless telecommunications device. The device may include a housing configured to be mounted on a telecommunications device. The housing may have an outer rear surface, at least two outer surfaces perpendicular to the rear surface, and a front region through which the image of the telecommunications device held in the housing can be viewed. The device may further include a first electrode on or adjacent to at least one of two outer surfaces, a second electrode on the outer rear surface and having an outer contact surface, and a third electrode on the outer rear surface and having an outer contact surface. The outer contact surfaces of the second and third electrodes may be recessed relative to at least a portion of the outer rear surface, such that when the housing is placed on a workbench surface with the outer rear surface facing the workbench surface, the outer contact surfaces of the second and third electrodes do not contact the workbench surface. Furthermore, the second and third electrodes may be arranged such that the patient can touch the outer contact surface of the second electrode with only their left hand and the outer contact surface of the third electrode with only their right hand while holding the first electrode against their leg, and can view the screen of the telecommunications device held within the housing.

[0115] The second and third electrodes may be entirely on the outer rear surface. The first electrode may be entirely on one of at least two outer surfaces. The first electrode may be located on the outer rear surface adjacent to one of at least two outer surfaces. The first electrode may extend along the edge between one of the outer surfaces and the outer rear surface. Each of the outer surfaces may be rectangular, and the first electrode may be centered between two short edges of one of the outer surfaces and may extend longitudinally in the direction of the long edge of one of the outer surfaces. The first electrode may extend on or adjacent to the outer surface for more than half the length of the outer surface. The second and third electrodes may be positioned symmetrically relative to each other with respect to the center of the outer rear surface. The second and third electrodes may be portions of the electrode unit fitted within an opening in the outer rear surface of the housing. The first electrode may have a surface area approximately the same as the surface area of ​​the second or third electrode. Specification 14 / 51 pages 17 CN 120899266 A

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

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

[0118] An aspect of the invention also provides an electrocardiogram (ECG) detection device for use with a wireless telecommunications device. The device may include a housing configured to be mounted on a telecommunications device. The housing may have an outer rear surface, at least two outer surfaces perpendicular to the rear surface, and a front region through which an image of the telecommunications device held within the housing can be viewed. The device may further include: a first electrode on or adjacent to at least two outer surfaces; a second electrode on an outer rear surface and having an outer contact surface; a third electrode on an outer rear 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 a wireless telecommunications device. The outer contact surfaces of the second and third electrodes may be recessed relative to at least a portion of the outer rear surface, such that when the housing is placed on a workbench surface with the outer rear surface facing the workbench surface, the outer contact surfaces of the second and third electrodes do not contact the workbench surface.

[0119] An aspect of the invention also provides a method for generating an electrocardiogram (ECG) from a patient using a handheld wireless telecommunications device housing having three electrodes on the outer surface of the housing. The patient can be instructed to follow alongThe first electrode extending from the side of the housing is held against the leg, while the patient touches the second electrode on the back of the housing with the right hand and the third electrode on the back of the housing with the left hand, such that the patient contacts no more than three electrodes on the housing. A first lead signal (lead I) of the ECG can be detected between the third electrode and the second electrode. A second lead signal (lead II) of the ECG can be detected between the second electrode and the first electrode. A third lead signal (lead III) of the ECG can be detected between the first electrode and the third electrode.

[0120] An aspect of the invention also provides a method for generating an electrocardiogram (ECG) from a patient using a handheld wireless telecommunications device housing having three electrodes on its outer surface. The patient can be instructed to hold the first electrode of the housing against their leg, while touching the second electrode with their right hand and the third electrode with their 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. Lead signals can be wirelessly transmitted (e.g., using ultrasound) from the housing to a telecommunications device.

[0121] This document also describes a wearable wristband device that can reliably and conveniently transmit information recorded by a user (e.g., ECG information) using ultrasound. A monitoring station is also described, which includes control logic for configuring and operating a mobile computing / telecommunications device to securely and reliably receive the ultrasound data.

[0122] Generally, this document describes apparatus, systems, and methods for transmitting digital and / or analog data from (and in some cases to) wearable (e.g., wristband) devices using ultrasound, the wearable device having one or more sensors, a microprocessor, and a transducer (i.e., a piezoelectric speaker) capable of transmitting ultrasonic frequencies. The digitally transmitted data can be received by a receiving device with a microphone (such as a telecommunications device (e.g., a personal telecommunications device, such as a telephone, iPad, or other smartphone, or PDA, etc.)), wherein the microphone is capable of receiving audio in the ultrasonic frequency range (e.g., greater than 17 kHz, greater than 18 kHz, between about 16 kHz and about 22 kHz, between about 17 kHz and about 30 kHz, between about 18 kHz and 32 kHz, between about 17 kHz and 42 kHz, etc.). As described in more detail below, the transmitted digital information can be encoded and / or encrypted using the specification (page 15 / 51, CN 120899266 A). Additionally, the information can be compressed (data compression) before encryption.

[0123] Both one-way (e.g., from wristband to device) and two-way communication are envisioned, including various methods for simple two-way communication between wearable devices and monitoring stations (e.g., smartphones).

[0124] This document also describes ultrasonic digital modems for securely transmitting digital signals using ultrasound from wearable devices such as wristbands to telecommunications devices configured as receivers, as well as digital modem protocols and logic.

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

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

[0127] This document further describes specific means and systems configured to include a digital ultrasonic modem. Any of these devices may include a digital information source (e.g., a device such as a medical sensor or device (e.g., a thermometer, 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., below ultrasound) sound (within normal human hearing).

[0128] In the example described herein, a Texas Instruments AFE4110 digital thermometer was modified as described to encode temperature data and transmit it ultrasonically to a telecommunications device (e.g., a smartphone) located at a distance from the thermometer. The microcontroller of the device (an MSP430 controller from Texas Instruments) has been configured to include an ultrasonic modem for transmitting ultrasonic digital data by encoding a data signal to be transmitted on a connected piezoelectric speaker (via a microprocessor). The speaker may be the same speaker preset in the thermometer and used to audibly (e.g., within the normal range of human hearing) notify the user that the temperature has stabilized. Thus, the thermometer can be modified to include a digital ultrasonic modem at very low cost by processing the data from the thermometer and transmitting the encoded signal on the piezoelectric speaker in the ultrasonic frequency range (e.g., >17 kHz). The thermometer may include a security key (e.g., barcode, QR code, etc.) printed on the exterior of the device and readable by a receiving telecommunications device (e.g., a smartphone).

[0129] For example, in some variations, this document describes a medical sensing device and a system including such a device, the instruction manual of which, on page 16 / 51 of 19 CN 120899266 A, describes an ultrasound device that transmits digital bio-parameters received by the medical sensing device to one or more telecommunications devices (e.g., a smartphone), where the information can be further processed and / or transmitted on the telecommunications device. Executable logic may also be referred to as an adapter for adapting the medical sensing device so that the medical sensing device can transmit bio-parameter information using ultrasound to the telecommunications device for further processing. Systems and / or subsystems for use with telecommunications devices are also described, enabling the telecommunications device to receive and translate health measurement information signals encoded in ultrasound. These subsystems may include client software (e.g., an application) to run on the telecommunications device (e.g., a phone) to translate ultrasound health information (or bio-parameter) signals into digital signals that can be uploaded, stored, and / or analyzed by the telecommunications device.

[0130] Medical sensing devices can be any device used to receive biological parameters (such as a patient's vital signs). Biological parameters can also be referred to as biometric data. For example, medical sensing devices can be thermometers, blood pressure transducers, glucose monitors, pulse oximeters, pulse rate meters, pedometers, activity monitors, hydration monitors, etc. The medical sensing devices or systems discussed herein are generally digital systems because they can display numerical (e.g., digital) representations of biological parameters. ExampleFor example, these devices can convert analog biological parameters (e.g., temperature, blood glucose, blood pressure, or any other health measurement information) into digital signals that can be displayed to a user or otherwise presented. For example, medical sensing systems may include digital thermometers for capturing a subject's temperature, blood cuffs for presenting a patient's blood pressure, blood glucose (glucose) monitors, or pulse oximeters, 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 the information on a display.

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

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

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

[0134] As used herein, telecommunications devices include smartphones (e.g., iPhone™, droid™, or other personal communication devices), tablet computers (e.g., iPads or tablet PCs, etc.), and / or desktop computers that include (or may be adapted to include) microphones capable of receiving ultrasonic sound. Telecommunications devices may include logic for translating digital signals encoded by ultrasonic sound into digital signals that can be displayed, uploaded / transmitted, stored, and / or analyzed.

[0135] Therefore, in some variations, this document describes a medical sensing device for transmitting digital bioparameters using ultrasound. In some variations, the device may include: a sensor for detecting bioparameters from a patient; a processing device for encoding a digital representation of the bioparameters into an ultrasound sound signal, as described on pages 17 / 51 of the specification (20 CN 120899266 A); and an ultrasound transducer for transmitting the ultrasound sound signal from the processing device.

[0136] For example, the sensor may be a transducer (temperature sensor, pressure sensor, etc.) for converting bioparameters. The device may also include a controller (e.g., a microcontroller) for processing signals from (one or more) sensors. The processing device may include a signal generator that generates a signal from the sensed and / or processed patient bioparameter information; the signal may be encoded for transmission. The signal may be encoded into digital packets (e.g., words, bytes, etc.). For example, the signal may include a start bit, a stop bit, one or more information bits (e.g., a packet identifier) ​​identifying the type or source of the bioparameter, a digital representation of the bioparameter, and, in some variations, a cyclic redundancy check (CRC) portion. In some variations, the signal (including biometric measurements or data portions) may have a time and / or date stamp.

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

[0138] In some variations, the system or device may be configured such that a measurement is performed at time x and stored on the device (e.g., a thermometer, blood glucose meter, etc.), and then transmitted ultrasonically to a telecommunications device (e.g., a smartphone or tablet) at a short time, and finally uploaded (e.g., to the cloud). In some variations, several time / date stamped measurements may be stored on the device and may be transmitted together to the telecommunications device in bursts. As described in more detail below, although in some variations the device may be primarily unidirectional (e.g., sending data from a biometric measurement device to a telecommunications device), the device may be configured to at least receive an acknowledgment signal and / or an indication of the proximity of the telecommunications device. In some variations, the ultrasonic transducer may also be configured to receive an acknowledgment signal from the telecommunications device. Confirmation can indicate that the telecommunications device has received the transmitted message (data) or that the telecommunications device is ready to receive the transmitted data, or both.

[0139] The ultrasonic transducer can be any suitable transducer (including piezoelectric crystal transducers).

[0140] In some variations, a system for transmitting digital bioparameters using ultrasound includes: a medical sensing device having a sensor for detecting the bioparameters, and a processor for encoding a digital representation of the bioparameters into an ultrasonic sound signal.The device includes a processing apparatus and an ultrasonic transducer for transmitting ultrasonic sound signals; and client control logic configured to be executed by the telecommunications device and to receive the ultrasonic sound signals and convert them back into a digital representation of the bioparameters.

[0141] The processing apparatus can convert some or all of the digital bioparameter signals (which are typically numerical) into ultrasonic signals using any suitable 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 telecommunications device. The client control logic may also include, for example, components for transmitting the digital representation of the bioparameters to other devices (e.g., uploading it to a website or server). In some variations, the client control logic can be configured to display or otherwise present information locally on the telecommunications device.

[0143] This document also describes a system for transmitting digital health parameters, the system comprising: an ultrasonic transducer capable of transmitting signals at frequencies above about 17 kHz (e.g., 19 kHz, or centered at 20 kHz) in an open-air environment; and a signal generator configured to generate ultrasonic signals corresponding to digital representations of biological parameters, wherein an identifier is associated with at least one frequency above about 17 kHz (e.g., 19 kHz, or centered at 20 kHz).

[0144] As an example, this document describes a digital thermometer for transmitting digital temperature information ultrasonically to a telecommunications device for further processing and transmission. The digital thermometer may include: a temperature sensor for sensing a patient's temperature; a signal generator for generating a signal corresponding to a digital representation of the patient's temperature; and an ultrasonic transducer for transmitting the digital representation of the patient's temperature as an ultrasonic signal including one or more frequencies above 19 kHz. The thermometer may include an external encryption key that can be imaged and / or observed by a user and / or an electrical device configured to receive ultrasonic signals.

[0145] Generally, this document describes a digital ultrasonic modem device for securely transmitting digital data using ultrasonic waves. Such a device may include: a microprocessor; an ultrasonic transducer; an encryption key located on the device; and ultrasonic transmission logic configured for acoustic transmission by the ultrasonic transducer at a frequency of 17 kHz or higher, the ultrasonic transmission logic also being configured to encrypt the digital data according to the encryption key.

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

[0147] Any system described herein can be configured as a system for secure ultrasonic transmission of data and may include: an ultrasonic communication device including an ultrasonic transducer, an encryption key located on the ultrasonic communication device, and ultrasonic transmission logic configuring digital data for acoustic transmission by the ultrasonic transducer at a frequency of 17 kHz or higher, the ultrasonic transmission logic being further configured to encrypt the digital data according to the encryption key; and decryption logic executable on a telecommunications device, wherein the telecommunications device includes a receiver for receiving ultrasonic signals from the ultrasonic communication device, and wherein the decryption logic is configured to receive the encryption key and apply the encryption key to decrypt the ultrasonic signals.

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

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

[0150] This document also describes a method for securely transmitting information using ultrasound. For example, in some variations, the method includes: receiving an encryption key present on the outer surface of an ultrasonic communication device; receiving an encrypted ultrasonic signal from the ultrasonic communication device; and decrypting the ultrasonic signal with the encryption key.

[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 may include: decrypting the ultrasonic signal in a telecommunications device. As described above, receiving the encryption key may include: imaging the encryption key using a camera on the telecommunications device.

[0152] Generally, any system described herein may use a hybrid digital and analog encoding. For example, an apparatus for transmitting digital and analog ultrasonic data (hybrid digital and analog data) may include: a microprocessor; an ultrasonic transducer; and hybrid transmission logic configured to generate a signal including digital data appended to the analog data for acoustic transmission by the ultrasonic transducer at a frequency of 17 kHz or higher.

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

[0154] In any of these variations, the device may include sensors for detecting biometric parameters from a patient, and / or a microprocessor configured to extract digital data from analog data. In some variations, digital data packets...This includes calibration data for analog data (e.g., minimum, maximum, variable intervals (e.g., time intervals), scale, etc.). Analog data may include any suitable signal typically measured from device sensors, such as EEG, subject temperature over time, subject glucose level over time, subject blood pressure over time, subject oxygen level over time, or subject physical activity over time, etc.

[0155] This document also describes a method for using ultrasound to transmit mixed digital and analog signals. For example, one method may include: generating an ultrasound signal that includes digital data encoded using frequency shift keying (FSK) appended to an analog signal, the analog signal including a frequency-modulated signal modulated at a frequency higher than 17 kHz; and acoustically transmitting the signal using an ultrasound transducer.

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

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

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

[0159] An ECG sensing wristband configured to transmit ECG information to a mobile telecommunications device or multiple devices is also described herein.

[0160] For example, this document describes a wireless wearable wristband device for receiving electrocardiogram (ECG) signals from a subject wearing such a device and transmitting that information to a mobile telecommunications device using ultrasound. The wristband device may include: a wristband body configured to be fitted around the 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 these signals to be transmitted as ultrasound signals for transmission by the ultrasound transducer at a frequency higher than about 17 kHz.

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

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

[0163] The device can also be configured to receive signals (e.g., ultrasonic signals) (including ultrasonic signals from mobile telecommunications devices). In some variations, the device also includes an ultrasonic receiver configured to receive ultrasonic signals from a mobile telecommunications device. This can also create pairing of information between devices (e.g., for synchronization, acknowledgment of transmission of information, etc.). A separate receiving ultrasonic transducer can be used, or the same ultrasonic transducer can be configured to both transmit and receive. For example, the ultrasonic transducer can be configured to transmit signals from the processing device as ultrasonic signals and (e.g., from a mobile telecommunications device) receive ultrasonic signals. Specification 20 / 51 pages 23 CN 120899266 A

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

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

[0166] Typically, any wristband device can be configured without a display or output, or only with audible output (e.g., beeping, tone) or with LEDs (e.g., simple indicator lights). Alternatively, the device can rely on communication with a base station such as a mobile telecommunications device to display and, in some cases, analyze the signal. For example, the device may includeAn indicator indicating when the device communicates with a mobile telecommunications device. Therefore, a wristband device excluding a display for showing ECG information can make the device smaller, lighter, and cheaper to manufacture and operate.

[0167] Furthermore, in some variations, these devices can be configured to store most of the data (e.g., ECG data) and transmit the data once a receiver, such as a mobile phone, is ready to receive it. Therefore, any of these variations can include additional information such as time / date stamps, user input data, etc. Therefore, in some variations, the device also includes a memory coupled to a processing device and configured to store encoded signals 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] Typically, the device (e.g., the processing device) can also be configured to determine when the mobile telecommunications device receives the encoded signal from the device.

[0170] The wristband device described herein can also be configured as a clock and can include a dial, etc.

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

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

[0173] In any of these device variations, the device can be configured to transmit and receive ultrasonic signals. For example, the device may include an ultrasonic receiver configured to receive ultrasonic signals from a mobile telecommunications device. In some variations, the same transducer used for transmitting ultrasonic signals (e.g., ECG signals) may also be configured to receive ultrasonic signals (e.g., quasi-ultrasound signals).(e.g., receiving, requesting transmission, confirming transmission, requesting retransmission). An ultrasonic transducer can be configured to transmit signals from a processing device as ultrasonic signals and receive ultrasonic signals from a mobile telecommunications device.

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

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

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

[0177] The device may also include a battery having a voltage of less than 1.8 ohms. The processing device can be configured to transmit encoded ECG signals in real time. The device may also include a memory coupled to the processing device and configured to store encoded signals for later transmission. The processing device can be configured to encode signals to be transmitted as digital signals. The device may also include an indicator indicating when the device is communicating with a mobile telecommunications device. The processing device may also be configured to determine when the mobile telecommunications device receives encoded signals from the device. The device may be configured as a clock.

[0178] Another aspect of the invention provides a wireless wearable wristband device for detecting electrocardiogram (ECG) signals from a subject wearing the device and wirelessly (e.g., using ultrasound) transmitting this information to a mobile telecommunications device. The wristband device includes a wristband body configured to fit around the wrist, two or more electrodes for detecting ECG signals from the subject, a wireless (e.g., ultrasound) transducer, and a processing device. The processing device may be coupled to the wireless (e.g., ultrasound) transducer and is configured to receive ECG signals from the two or more electrodes and encode the signals to be transmitted into a hybrid wireless (e.g., ultrasound) signal for transmission, the hybrid wireless signal including digital information appended to an analog representation of the ECG signal. The ultrasound transducer may transmit the signal at a frequency higher than about 17 kHz.

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

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

[0181] Another aspect of the invention provides a wireless wearable wristband device for detecting electrocardiogram (ECG) signals from a subject wearing the device and wirelessly (e.g., using ultrasound) transmitting this information to a mobile telecommunications device. The wristband device may include a wristband body configured to be fitted around the wrist, two or more electrodes for detecting ECG signals from the subject, a wireless (e.g., ultrasound) transducer configured to transmit and receive ultrasound signals, and a processing device coupled to the wireless (e.g., ultrasound) transducer and configured to receive ECG signals from the two or more electrodes and encode the signals to be transmitted into wireless (e.g., ultrasound) signals for wireless (e.g., ultrasound) transmission. Ultrasonic transducerThe device can transmit signals at frequencies higher than about 17 kHz. The processing unit can be configured to receive ultrasound signals from a mobile telecommunications device.

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

[0183] FIG1 shows a schematic diagram of a system 1000 for measuring and monitoring one or more biometrics or physiological parameters of a user US. The system 1000 may include a computing device 1100 and an external sensor device 1200 for coupling or removably attaching to the computing device 1100. Computing device 1100 may include one or more of the following: personal computer, laptop computer, tablet computer (such as Apple iPad, Apple iPod, Google Nexus tablet, Samsung Galaxy tablet, Microsoft Surface, etc.), personal digital assistant (PDA), smartphone (such as Apple iPhone, Google Nexus phone, Samsung Galaxy smartphone, etc.), and 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 smartphone. External sensor device 1200 may be configured to be removably coupled to computing device 1100 and may include a cover for covering the computing device, such as a tablet computer casing or a smartphone casing or cover. In this way, when the user replaces or upgrades his or her computing device 1100, it may 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 may have.

[0184] The computing device 1100 may include a processing device 1110, a memory unit 1120 such as a RAM module, a data storage unit 1130 (e.g., a flash memory module, a hard disk drive, ROM, etc.), a network interface 1140 configured to connect to, for example, a cellular data network (e.g., using GSM, GSM plus EDGE, CDMA, quad-band or other cellular protocols) or a WiFi network (e.g., 802.11 protocol), a local interface 1150, an operating system 1160 (which may be stored on the data storage unit 1130, loaded onto the memory unit 1120, and implemented by the processing device 1110), and a first application 1170 (e.g., distributed from an online application).The computing device 1100 includes a first mobile software application (“mobile app”) downloaded from a platform, a second application 1180 (such as a second mobile software application (“mobile app”) downloaded from an online application distribution platform), and a user interface 1190. For example, the online application distribution platform could be the Apple App Store, Google Play, Windows Phone Store, or BlackBerry App World. The operating system 1160 may include instructions for operating the computing device 1100. The user interface 1190 may include a display 1195 for displaying one or more components of the operating system 1160, the first application 1170, or the second application 1180. For example, the display 1195 may be a touchscreen display for manipulating and controlling the operating system 1160, the first application 1170, or the second application 1180. One or more of these components may be combined or omitted. The computing device 1100 may also include other components such as a motion detection component, one or more cameras, an additional display, a power supply, a fan, various I / O ports, etc.

[0185] The external device 1200 may include a sensor 1210, a processing device 1220, and a local interface 1230. The sensor 1210 is configured to be coupled to a user US via a connection 1215 (e.g., physical contact) to sense or detect one or more physiological parameters of the user US. Typically, one or more physiological parameters include the user's cardiac parameters, such as heart rate, heart rate variability, blood pressure, blood pressure variability, arrhythmia, electrocardiogram (SCG), SCG parameters, electrocardiogram (ECG), or ECG parameters, etc. Other physiological parameters are also considered. For example, the sensor 1210 may include an activity sensor, a blood glucose sensor, a blood oxygen sensor, a temperature meter, a respiration sensor, a metabolic sensor, or an odor detector, etc. The processing device 1220 may receive the detected physiological parameters and process them into signals for use by the local interface 1230 to transmit via connection 1235 to the local interface 1150 of the computing device 1100. Connection 1235 may include a wired connection, such as a USB connection, a FireWire connection, or a Lightning connection. Alternatively or in combination, connection 1235 may include a wireless connection, such as a WiFi connection, a Bluetooth connection, a Bluetooth Low Energy connection, an NFC (Near Field Communication) connection, or a near-field ultrasonic communication connection as described in U.S. Patent Nos. 8,301,232 and 8,509,882.

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

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

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

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

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

[0191] The electrical activity of the heart of user US may also include one or more characteristic durations or intervals that can be used to distinguish different users. For example, the electrical activity of the heart may include PR intervals and ST segments as known in the art. The PR interval can be measured from the beginning of the P wave to the beginning of the QRS complex. The PR interval can typically last from 120 to 200 ms. PR intervals with different durations may indicate one or more defects in the heart, such as first-degree heart conduction block (e.g., PR intervals lasting longer than 200 ms), pre-excitation syndrome via an auxiliary pathway leading to early ventricular activation (e.g., PR intervals lasting less than 120 ms), or another type of heart conduction block (e.g., variable PR intervals). The ST segment can be measured from the QRS complex to the T wave (e.g., starting at the junction between the QRS complex and the ST segment and ending at the beginning of the T wave). The ST segment can typically last from 80 ms to 120 ms and typically has a slightly upward concavity. The combination of ST segment length and ST segment concavity or height can also be used to generate heart rate-specific characteristic information for each user.

[0192] The T wave can represent ventricular repolarization or recovery. The interval from the beginning of the QRS complex to the apex of the T wave can be called the absolute refractory period. The last half of the T wave can be called the relative refractory period or 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 the characteristics of a 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 user's heart rate status. Several correction factors have been developed to correct the QT interval of the heart rate. 222 Measured QT interval values ​​and corrected QT interval values ​​are compared.Interval values ​​can be used to define unique characteristics of a user's heartbeat.

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

[0195] System 1000 can be used to authenticate user US based on a comparison of measured electrical activity of user US’s heart with a generated profile. If the measured electrical activity matches the generated profile, processing device 1110 can authenticate user US under instructions from operating system 1160, first application 1170, or other applications. Processing device 1110 can also be instructed to perform any appropriate actions in response to identifying and authenticating user US. In some embodiments, processing device 1110 can be instructed to provide access to restricted applications (e.g., applications that only specific users have licenses for or that only specific users have purchased). In some embodiments, processing device 1110 can be instructed to provide access to specific data or application settings associated with authorized user US. For example, processing device 1110 can be instructed to provide access to the contact list of the identified user US, or access to the email account or telephone history of the identified user US. As another example, the processing device 1110 may instruct the user US to access a private banking application or conduct financial transactions (e.g., transfer funds to different accounts or purchase goods) using an electronic device. In some embodiments, the computing device 1100 may load user US settings and profiles to provide a customized display to the user. For example, the computing device 1100 may display icons or options in a manner set by the user, or provide a display using a color scheme, font, or other customizable display attributes associated with the identified user.

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

[0197] In some embodiments, the computing device 1100 may provide media playback based on the detected mood or heart signal of the user US. For example, the computing device 1100 may identify media having a heart rate or other characteristics associated with or related to the heart signal or heart rate of the user US and play back the identified media. As another example, the provided media may have a heart rate that is faster or slower than the user's current heart rate to encourage the user to exercise harder (e.g., during a workout) or to cool or calm the user (e.g., at the end of a workout).

[0198] Aspects of the invention may also include processing for operating the computing device based on cardiac signals from a user (US). In a first step, system 1000 may detect cardiac signals from the user (US). For example, a sensor 1210 of an external device 1200 may be used to detect the user's heart rate or heartbeat. The external device 1200 may transmit the detected signal to the computing device 1100 via connection 1235. The computing device 1100 may process the received signal using any suitable method (including determining unique characteristics of the signal). Such characteristics may include, for example, the duration between peaks in an EKG signal, the peak value or distribution between peaks in an EKG signal, or any other suitable characteristics as described herein. In a further step, the computing device 1100 may determine whether the previously detected user (US) is an authorized user. For example, the computing device 1100 may compare the determined characteristics of the detected cardiac signal with a signal library 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 cardiac signal stored in memory), the computing device 1100 may prevent access to restricted electronic device operation in a further step. For example, the computing device 1100 may prevent the user from accessing personal or private information associated with other users. As another example, the computing device 1100 may prevent the user US from accessing applications or operations associated with a specific user (e.g., applications purchased by a specific user). As yet another example, the computing device 1100 may prevent the user US from accessing any electronic device operation (e.g., no operation except for emergency calls).

[0199] If the computing device alternatively determines that the user US is authorized, the process may proceed to a fourth step, in which...In this step, computing device 1100 determines restricted operations associated with user US. For example, computing device 1100 may determine specific private data associated with an authorized user (e.g., email accounts, contact lists, and banking information). As another example, computing device 1100 may determine specific operations or applications associated with authorized user US (e.g., applications purchased by user US using an app store, or systems that control operations associated with managing accounts). In the fifth step, computing device 1100 may provide access to the determined restricted operations of user US. For example, computing device 1100 may load the determined data. As another example, computing device 1100 may provide a link for launching the determined personal or private application.

[0200] While the second application 1180 is in the foreground of display 1195 and is being actively manipulated by user US, the first application 1170 may also run in the background of operating system 1160 to receive, store, and analyze one or more physiological data. For example, the second application 1180 may include an email application, web browser, music player, or game in which the user US operates as the first application 1170 and the external sensor device 1200 measures one or more of the user's physiological parameters in the background.

[0201] For example, the external sensor device 1200 may include a variety of form factors depending on the form of the computing device 1100 and its convenience to the user US.

[0202] Figures 2A to 2K illustrate a biometric or physiological parameter measurement and monitoring system 2000 including a smartphone 2100 and a protective smartphone housing 2200. Figure 2A shows a perspective view of the system 2000, wherein the smartphone 2100 and the protective smartphone housing 2200 are separate. The protective housing 2200 has a cavity 2200C for accommodating the smartphone 2100. Figure 2B and specification page 26 / 51 29 CN 120899266 A Figure 2C shows a rear view of the system 2000. Figure 2D shows a perspective view of system 2000, wherein a smartphone 2100 and a protective smartphone housing 2200 are coupled to or removably attached to each other. The smartphone 2100 may include, for example, an Apple iPhone, a Google Android smartphone, a Google Nexus, a Samsung Galaxy phone, an HTC smartphone, a Nokia Windows smartphone, or a Blackberry smartphone, etc.

[0203] The smartphone 2100 may include a front panel 2110, an edge 2120, a rear panel 2130, and a display 2140 on the front panel 2110. The protective smartphone housing 2200 may include multiple [unclear - possibly related to sensors or devices] for detecting physiological parameters such as an electrocardiogram (ECG).Electrodes. Multiple electrodes may include a first electrode 2210 and a second electrode 2220. When the smartphone 2100 and the protective housing 2200 are coupled together, at least some of the electrodes will be arranged on the edge 2120 of the smartphone 2100. In this way, for example, for user convenience, the smartphone 2100 can maintain a thin profile and low profile. As shown in FIG2B, the first electrode 2210 and the second electrode 2220 may be arranged opposite each other on the top and bottom edges (i.e., the shorter edges) of the protective housing 2200, respectively. As shown in FIG2C, the first electrode 2210 and the second electrode 2220 may be arranged opposite each other on the left and right edges (i.e., the longer edges) of the protective housing 2200, respectively. FIG2B and 2C show the back surface 2200B of the protective housing 2200. The electrodes will generally be electrically isolated from each other to avoid short circuits or interference. The electrodes will also generally protrude from the body of the protective housing 2200 to a minimum. For example, the electrodes may be polished, roughened, or otherwise finished to match the outer surface of the protective housing 2200.

[0204] The sensor electrodes described herein may be made of any suitable material. For example, the electrodes may be made of a specific material selected for specific conductivity properties that allow for more efficient transmission of electrical signals reflecting the user's cardiac activity. The electrodes may be made of silver-based compounds, which can provide excellent conductivity relative to other metallic compounds (e.g., steel or aluminum). The size and position of the electrodes may also be selected to ensure adequate contact between the user (e.g., the user's hand or fingers) and the electrodes. For example, each electrode may include a pad or extended area placed on the outer surface of the body of the external sensor device 1200.

[0205] In use, as shown in Figures 2E and 2F, a user may hold the system 2000 with their hand so that the first electrode 2210 contacts the user's right arm RA and the second electrode 2220 contacts 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 is 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. Lead I ECG can be measured by contacting multiple electrodes with the right arm RA and left arm LA. The user US can also contact the first electrode 2210 with the right arm RA and left leg LL to measure lead II ECG. The user US can also contact the first electrode 2210 with the right arm RA and left leg LL to measure lead III ECG.

[0206] Other placements of the multiple electrodes are also envisioned. As shown in Figure 2G, the first electrode 2210 and the second electrode 2220 canThe electrodes are arranged at the corners of the protective housing 2200. Furthermore, the plurality of electrodes may include a third electrode 2230. As shown in FIG2H, the first electrode 2210 and the second electrode 2220 may be arranged on the top and bottom edges (i.e., the shorter edges) of the protective housing 2200, while the third electrode 2230 may be present on the side or longer edge of the protective housing 2200. As shown in FIG2I, the first electrode 2210 and the second electrode 2220 may be arranged at opposite corners of the protective housing 2200, while the third electrode 2230 may be present on the side or longer edge of the protective housing 2200. As shown in FIG2J, the first electrode 2210 and the second electrode 2220 may be arranged on the left and right edges (i.e., the longer edges), while the third electrode 2230 may be present on the side or longer edge of the protective housing 2200. In some embodiments, the first electrode 2210 and the second electrode 2220 may be arranged on the edge of the protective housing 2200, and the third electrode 2230 may be arranged on the back surface 2200B of the protective housing 2200.

[0207] In use, as shown in FIG2K, a user can hold the system 2000 with their hands so that the first electrode 2210 is in contact with the user's right arm RA, the second electrode 2220 is in contact with the user's left arm, and the third electrode 2230 is in contact with the user's left leg LL to measure one or more physiological parameters such as heart rate or ECG. As shown in FIG2K, a second application 1180 (e.g., an email application) may be active on the system 2000 and may be operated by the user US while the first application 1170 receives physiological parameter data in the background. By contacting multiple electrodes 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. It is even possible to simultaneously measure lead I ECG, lead II ECG, and lead III ECG. A wireless ECG device with three electrodes is further described in co-owned U.S. Provisional Patent Application No. 61 / 845,254, filed July 11, 2013, entitled “Three-Electrode Wireless ECG Apparatus” (the contents of which are incorporated herein by reference).

[0208] Figures 3A through 3F illustrate a biometric or physiological parameter measurement and monitoring system 3000 including a tablet computer 3100 and a protective tablet computer housing 3200. System 3000 may be similar to system 2000 in many respects. However, system 2000 is adapted for use with a smartphone 2100, and system 3000 is adapted for use with a tablet computer 3100. Tablet computer 3100 may include Apple iPad, Google…Nexus tablet computers, Samsung Galaxy tablet computers, or Microsoft Surface tablet computers, etc.

[0209] FIG3A shows a perspective view of system 3000, wherein a protective housing 3200 has a cavity 3200C for accommodating a tablet computer 3100. The tablet computer 3100 has a front 3110, an edge 3120, a back 3130, and a display 3140. FIG3B shows a tablet computer 3100 coupled or removably attached to the protective housing 3200.

[0210] FIG3B also shows that the tablet computer protective housing 3200 may include a plurality of sensor electrodes including a first electrode 3210 and a second electrode 3220. As shown in FIG3B and FIG3C, the first electrode 3210 and the second electrode 3220 may be arranged opposite each other on the edge 3120 of the tablet computer 3100. Other alternative placements are also contemplated. For example, FIG3D shows the first electrode 3210 and the second electrode 3220 arranged on the back 3130 of the protective housing 3200. Furthermore, as shown in FIG3E, the plurality of electrodes may also include a third electrode 3230 disposed on the back surface 3130 of the protective housing 3200.

[0211] The system 3000 may be used to measure physiological signals in a manner similar to that of the system 2000 described above. For example, the plurality of electrodes of the system 3000 may be in contact with the user US to measure one or more of leads IECG, lead IIECG, and lead III ECG. As shown in FIG3F, the user US may normally operate the system 3000 and the tablet computer 3100, while the first electrode 3210 contacts the user's right arm RA, the second electrode 3220 contacts the user's left arm LA, and the third electrode 3230 (not shown) contacts the user's left leg. Although FIG3F shows that the first application 1170 for managing the detected (one or more) physiological parameters is active on the tablet computer 3100, it is also conceivable that during the sensing and detection of (one or more) physiological parameters by the first application 1170 and the protective housing 3200, the second application 1180 is instead active and manipulated by the user US.

[0212] Other computing device accessories are also envisioned for simultaneously measuring (one or more) various physiological parameters of the user US during normal use of the computing device.

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

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

[0215] Additional sensor accessories for coupling with everyday devices are also envisioned. For example, embodiments of the invention may provide sensor accessories for handlebars, seats, chairs, glasses, clothing, etc., of exercise equipment such as bicycles, motorcycles, treadmills or elliptical trainers or weightlifting machines. As another example, the sensor system described herein may take the form of a watch, wristband, wrist strap, or accessory of these devices. ECG sensing watches and wristbands are described in co-owned U.S. Provisional Patent Application No. 61 / 872,555, filed August 30, 2013, entitled “Ultrasonic Transmission of Signals from an ECG Sensing Wristlet.” Sensor accessories can detect and measure one or more physiological parameters and communicate the measurement results to a computing device or another computing device associated with an everyday device.

[0216] Figure 6 illustrates a method 6000 for measuring and monitoring biometrics or physiological parameters. In step 6050, a computing device such as computing device 1100 described herein may be provided. In step 6100, an external device or housing for the computing device, such as external device 1200 as described herein, may be provided. In step 6150, the external device or housing may be coupled to the computing device. For example, see system 2000 (Figures 2A-2D), system 3000 (Figures 3A-3B), system 4000 (Figures 4A-4C), and system 5000 (Figures 5A-5C) as described herein. In step 6200, a physiological signal or parameter measurement and monitoring application may be downloaded to the computing device. The application may include the first application 1170 described above and may be downloaded from an application distribution platform via the Internet as described herein. In step 6250, [the application may be downloaded].An application runs on the computing device. In step 6300, an external device or housing coupled to the computing device may be brought into contact with the user to measure (one or more) physiological parameters. In step 6350, (one or more) physiological signals or (one or more) parameters may be measured. In step 6400, (one or more) physiological signals or (one or more) parameters may be stored, displayed, or otherwise processed. In step 6450, the physiological signal or parameter measurement and monitoring application may be placed in the background of the computing device. In step 6500, while the physiological signal or parameter measurement and monitoring application is performing its work in the background, a second application may run on the computing device.

[0217] Although the above steps illustrate a method 6000 for measuring and monitoring biometrics or physiological parameters, 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 advantageously as possible.

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

[0219] Generally, this document describes devices and methods for generating electrocardiograms (ECGs) from a patient comprising a handheld wireless telecommunications device housing having three electrodes on the outer surface of the housing. These devices and methods may allow a user to obtain up to six leads (e.g., lead I, lead II, lead III, aVR, aVL, and aVF) using a single handheld device that is easily held by the patient against his or her leg while observing the device's display. In particular, the device may be used in conjunction with a mobile telecommunications device (e.g., a smartphone). In another embodiment, the device is capable of operating as a standalone device, having appropriate circuitry to function independently or communicate with a separate telecommunications device.

[0220] Typically, the devices (including apparatus and systems) described herein may include three electrodes and are configured for use with wireless telecommunications devices. Wireless telecommunications devices may be any suitable telecommunications device, including smartphones (e.g., iPhone™, Android™, etc.), tablet computers (iPad™, etc.), laptops, PDAs, etc. The device may be configured as a housing and / or accessory for a mobile telecommunications device. The device can wirelessly communicate information to the mobile telecommunications device. In some variations...In this document, the system described herein sends information to (e.g., via an operating program or application (“app”), etc.) a mobile telecommunications device configured to receive and analyze information from the device.

[0221] Therefore, generally, the device described herein may include a housing configured as a casing, etc. The casing typically includes an outer surface with three (or more in some cases) electrodes arranged. In a variant where the casing is configured to hold a mobile telecommunications device, the casing may have an outer rear surface and at least two outer surfaces perpendicular to the rear surface, and a front region through which the screen of the telecommunications device held in the casing can be seen.

[0222] For example, Figures 9A to 9D illustrate a variant of a casing configured as a smartphone casing. In this example, casing 300 is shown as having a mobile telecommunications device (smartphone) 301 housed within the casing. Casing 300 includes a back (shown in Figure 9C) and sides (shown in Figures 9B and 9D). The front of casing 300 in this example has an opening 301 through which the front of the smartphone (including the screen) can be seen and / or touched. The housing may also include openings on the sides for telephone control (e.g., Figure 9B).

[0223] Typically, the housing also includes at least (and in some variations, exactly) three electrodes, each for contacting the subject's right hand, left hand, and leg. For example, the first electrode may be configured to be held against the patient's leg. The second and third electrodes may also be configured and arranged on the housing such that the patient can touch the second electrode with 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 may be configured such that when measuring ECG, the patient's hand does not contact more than one electrode on the housing, and the patient's leg does not contact more than one electrode on the housing. For example, the first electrode may be located on the side or side edge (rear edge) of the housing or both, while the second and third electrodes are located on the back, and all electrodes are spaced far enough apart from each other to avoid the leg or hand contacting more than one electrode. Thus, the left hand can contact a single electrode, the right hand can contact another electrode, and the leg can contact the first (leg) electrode, which is entirely on the same housing.

[0224] In FIG. 9A, the electrodes are arranged such that the first electrode 309 is on one of the outer surfaces of the housing. Placing the first electrode on the side of the housing allows the first electrode to be easily held against the subject's leg while the patient holds the housing, so that their first (e.g., left) hand contacts the second electrode and their other (e.g., right) hand contacts the second electrode.

[0225] Typically, in any device described herein, the electrodes can be on the outer surface of the housing; in some variations, the housing can be configured (or may include additional elements) to protect a [device] when the device is set on a surface such as a workbench.Or more than one electrode is exempt from contact with the surface. When the device is placed on a conductive surface (e.g., a metal workbench), the housing or additional features can prevent the outer surfaces of the electrodes from contacting the surface. For example, the electrodes on the outer surface of the housing can be recessed relative to at least a portion of the outer rear surface, such that when the housing is placed on the workbench surface with the outer rear surface facing it, the outer contact surfaces of the first, second, and / or third electrodes do not contact the workbench surface.

[0226] As described above, placing the first electrode on the side surface allows the device to be used for measurements from the leg while viewing the surface of the telecommunications device (e.g., a screen) inside the housing.

[0227] In Figures 9A to 9D, the housing includes only three electrodes 309, 311, and 313, and the first (leg) electrode is located on the side outer surface of the housing. The side (first) electrode is configured to extend along most of the length of the side of the housing. The second electrode 311 and the third electrode 313 are positioned closer to the center of the rear outer surface of the housing. As is evident in the side profile views of Figures 9B and 9D, the housing protects the second and third electrodes because the height of the electrodes is lower than the outer surface of the rest of the housing. Specification 30 / 51 pages 33 CN 120899266 A

[0228] Figures 10A to 10D illustrate another variation of the housing with three electrodes. However, in this example, the first (leg) electrode 413 does not have an outer surface lower than the outer surface of the 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 as if there is no mobile telecommunications device (e.g., a smartphone) inside 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 the edge of the housing (e.g., close to the side edge). Typically, the leg electrode can be adjacent to one of the side surfaces. The electrode can be close to the side and can contact the edge. Figures 12A to 12C illustrate a housing configured such that the first electrode 613 is adjacent to the side of the housing; the second electrode 609 and the third electrode 611 can be offset away from the first electrode to prevent unintentional contact between the subject's hand and the leg electrode (or another electrode).

[0231] Figures 13A to 13C illustrate another variation of the housing, as shown, which has a first electrode 709 extending from the rear surface and around the side edge of 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 makes it easier to access the leg and hold the housing at an angle.

[0232] In some variations, the housing can be configured to hold electrodes fitted within an opening in the outer rear surface of the housing.The electrode unit includes a second electrode and a third electrode (and in some variations a first electrode), and may also include circuitry for controlling / receiving ECG recordings. For example, Figures 14A to 14C illustrate a device configured with a housing that holds an electrode unit 805 including a second electrode 811 and a third electrode 813 to be touched by the patient’s right and left hands, and a separate first electrode 809 on the side of the housing. The electrode unit may extend from the housing and may 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 a worktable.

[0233] Figures 15A to 15C illustrate another variation of the three-electrode housing, wherein, as shown, all three electrodes (first electrode 909, second electrode 911, and third electrode 913) are arranged on the rear surface of the housing.

[0234] Although many of the variations described herein have all three electrodes integrated on the outer surface of the housing, in some variations one or more of these electrodes may be configured to extend from the surface of the housing. For example, Figures 16A and 16B illustrate an example of a device having a first electrode 1009 that can extend from the housing on a lead wire. When not in use, the lead wire can be retracted into the housing, and the electrode 1009 can be coupled to the housing. In use, the electrode can be pulled out from the housing and can contact the patient's leg, so that the housing and the smartphone can be held and viewed by the patient. In any of these variations, the smartphone can provide visual feedback to the patient before or during recording. For example, indicating that good electrical contact is being made, and / or showing the trace of ECG captured by the system.

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

[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 simultaneously identify lead I (e.g., the voltage between the left leg and right arm) with lead II (e.g., the voltage between the left leg and right arm) and simultaneously identify lead I with lead V2. In other embodiments, any other combination of leads is possible. The processing logic can then enable twoThe recording time is aligned so that the two sets of measurements can be compared within the same simulated 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 networks, deep learning techniques, etc.) to perform this transformation. The machine learning model can be trained using 12-lead ECG data corresponding to an individual group. The data can be preprocessed to filter the data in a way suitable for the application before being input into the machine learning model. For example, the data can be categorized according to height, sex, weight, nationality, etc., before being used to train one or more machine learning models, allowing fine-tuning of one or more models thus obtained for specific types of individuals. 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 using only three electrodes in a single device. As described herein, the three electrodes can be positioned on the device in any suitable manner (including two on the front of the device and one on the back).

[0239] Generally, this document also describes apparatus and systems for transmitting information (e.g., biometric information) from a wearable (e.g., wristband) sensing device to a telecommunications device using an ultrasonic transmission device, which can then process and / or transmit the biometric information. In particular, biometrics may include ECG signals. Wearable devices typically include ultrasonic transducers, which may be part of an ultrasonic modem module / subsystem for encoding and transmitting information as acoustic ultrasonic signals. 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, ultrasonic signals (e.g., encoded ECGs) can be securely transmitted using an encryption key. This document also describes systems, methods, and apparatus for easily pairing an ultrasonic transmission device with a telecommunications device using an encryption key. For example, in some variations, the telecommunications device can read an encryption key displayed on the ultrasonic transmission device (e.g., capture its image). This technique can be easily performed by using a telecommunications device to capture an image of a marker (e.g., a barcode, QR code, etc.) containing an encryption key and determining the encryption key based on the image. Executable logic (e.g., decryption logic) running on the telecommunications device can be configured to interpret and apply the encryption key.

[0241] For example, a system capable of transmitting digital bioparameter information using ultrasound may include sensors for sensing bioparameters (e.g., vital signs), and a configuration for representing the bioparameters as “digital” ultrasound signals, analog signals, or...A processing device for mixing digital / analog signals, and a transducer for converting ultrasonic signals so that they can be transmitted in the open to a telecommunications-capable device. The processing device may be part of a controller (e.g., a microcontroller), controlled by the controller (e.g., a microcontroller), or communicating with the controller (e.g., a microcontroller). The telecommunications-capable device (telecommunications device) may include a receiver (audio receiver) capable of receiving audio signals within the ultrasonic range, and a processing device for converting the ultrasonic signals back into electronic signals for further processing or transmission.

[0242] The range of human hearing is generally referred to as 20 Hz to 20 kHz; however, under ideal laboratory conditions, the maximum hearing range of children is actually as low as 12 Hz, and in a few cases as high as 20 kHz. Furthermore, as shown in Figure 18, the threshold frequency (i.e., the minimum detectable intensity) rises rapidly to the pain threshold between 10 kHz and 20 kHz. Therefore, sounds above approximately 16 kHz must be quite strong to be heard. The threshold sound levels of these higher frequencies increase almost from birth. As shown in Figure 19, the average 20-year-old loses about 10 dB in the 8 kHz range, while the average person loses more than 100 dB at this frequency by age 90.

[0243] An example product using very high-frequency sounds 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. Due to adult hearing loss at this frequency, it is typically only heard by people under 25 years old. Similarly, students exploit adult hearing loss by using a 15-17 kHz “mosquito” ringtone on their phones during school hours. The students can hear the mosquito ringtone, but their adult teachers cannot. The term “ultrasound” generally refers to a range above human perception. However, as shown in the figure, the upper limit of hearing frequency generally varies with the individual and age. Due to this difference in the upper limit, the term “ultrasound” as defined herein and in the appended claims may refer to sound frequencies of 16 kHz or higher (e.g., greater than about 17 kHz, greater than 18 kHz, etc.).

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

[0245] Acoustic engineers safely assume that any frequency above about 20 kHz will have no effect on perceived sound and that everything above that range can be filtered out. Sounds below 20 kHz but still within the ultrasonic range are almost ignored, and standard sampling procedures have been established accordingly. It is generally understood that for analog signals (whether radio signals or audible sounds)...Sampling a signal requires a sampling frequency fs that satisfies fs / 2>f, where f is a sinusoidal frequency. For this reason, sound systems are designed to sample sound at the current standard sampling rate of 44.1 kHz, which is set slightly higher than the Nyquist-Shannon sampling rate of 40 kHz calculated for a sound upper limit of 20 kHz. Demodulating FM narrowband signals in the ultrasonic range using existing demodulation processes, computers, telephones, cellular phones, stereo systems, etc., will result in very poor reproduction of the original signal. This is unfortunate because, as mentioned above, carrier signals in the ultrasonic range will also have a very low signal-to-noise ratio due to the fact that there is very little natural “noise” at these higher frequencies.

[0246] Apparatus, 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 with a significantly improved signal-to-noise ratio compared to conventional telephone transmission methods. Methods and algorithms for receiving and demodulating ultrasonic signals with excellent accuracy using existing computer and smartphone technologies are also provided.

[0247] Figure 21A shows a schematic overview of a system including a data input 0433 (e.g., providing any kind of information, including digital and / or analog information) and a microcontroller 0405. In some variations, the microcontroller includes or is coupled to a processing device for encoding a digital representation of biological parameters, and the encoded signal can be converted into an ultrasonic signal, as described in more detail below. For example, the encoded signal can be transmitted using ultrasound by an ultrasonic transducer 0407. In some variations, the microprocessor and the transducer can be coupled together or formed as part of the same component 0405'; alternatively, the microprocessor may include a piezoelectric / speaker element. The ultrasonic signal 0420 can then be received by a telecommunications device 0425 including an audio pickup (receiver) 0429. Telecommunication device 0425 can run client control logic 0427, which prepares the telecommunication device to receive and translate ultrasonic signals so that the ultrasonic signals can be processed, for example, converting the ultrasonic signals back into electronic signals and interpreting what type of signal the ultrasonic signals are (e.g., pulse rate, temperature, etc.).

[0248] FIG21B shows a schematic diagram of a system including a medical sensing device 0401 (e.g., a thermometer or blood glucose monitor, etc.), which has a microcontroller 0405 and a sensor 0403 for detecting biological parameters (e.g., body temperature, pulse rate, blood glucose, etc.) from a patient. The microcontroller may include or be coupled to a processing device for encoding a digital representation of the biological parameters, and the encoded signal may be converted into an ultrasonic signal, as described in more detail below. For example, the encoded signal may be transmitted with ultrasound by an ultrasonic transducer 0407. The ultrasonic signal is then...0420 can be received by a telecommunications device 0425 including an audio pickup (receiver) 0429. The telecommunications device 0425 can run client control logic 0427, which prepares the telecommunications device to receive and translate ultrasound signals so that the ultrasound signals can be processed, for example, to convert the ultrasound signals back into electronic signals and to interpret what type of signal the ultrasound signals are (e.g., pulse rate, temperature, etc.).

[0249] Thus, the medical sensing device 0401 in this example includes a sensor (or sensor assembly) configured to sense one or more physiological signals such as temperature, pulse, or pressure (e.g., blood pressure). The sensor can generate electrical signals representing the sensed physiological signals as described on page 33 / 51 of the specification 36 CN 120899266 A, and these signals can be converted into one or more digital signals input to a microcontroller or other associated components. The digital signal can typically be displayed on a device (not shown) and can also be electrically encoded as part of a digital signal, which can then be (e.g., via techniques such as frequency shift keying) encoded into ultrasonic sound and transmitted from the device. The encoding of the signal can be performed by any suitable circuitry (e.g., a microcontroller including an MSP430 (e.g., an AFE4110 from Texas Instruments) etc.).

[0250] The center frequency can be selected from any suitable ultrasonic frequency (including (but not limited to) 20 kHz). In some variations, the medical sensing device described herein is configured to transmit only, such that data is transmitted to a telecommunications device (but not received from a telecommunications device). In some variations, the medical sensing device is configured to transmit and receive ultrasonic (sound) frequency information (e.g., see Figures 21C and 27). Furthermore, in some variations, multiple channels (frequency channels) can be used.

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

[0252] In one embodiment, the center frequency of the ultrasonic signal is in the range of about 17 kHz to about 32 kHz. In anotherIn the embodiments, the center frequency of the frequency-modulated ultrasound signal is in the range of about 18 kHz to about 24 kHz, or about 20 kHz to about 24 kHz.

[0253] Figure 22 shows a variation of the digital signal using key-shift encoding. 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 selected 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 the ECG signal; however, the sensor can generally include any suitable sensor operable to detect physiological signals that the user wishes 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, photoplethysmography (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 hemoglobin in a non-invasive manner, rather than measuring it directly from a blood sample. The sensor is placed on a thin part of the human body (such as a fingertip or earlobe), and light containing red and infrared wavelengths is transmitted from one side to the other. The change in absorbance of each wavelength in the two wavelengths is measured, and the difference is used to estimate the change in blood oxygen saturation and blood volume in the skin. A photoplethysmography (PPG) can then be obtained using a pulse oximeter sensor or 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 transmitted as described herein. In some variations (described below with reference to Figures 26A and 26B), analog information can also be encoded and / or appended to digital information to form a mixture of analog and digital information transmitted by the ultrasonic transmitting device.

[0255] In some variations, the converter assembly encodes the electrical (e.g., digital, analog, etc.) information of biological parameters into an ultrasonic signal that can be transmitted. In the embodiment shown in Figure 21A, the converter assembly 0405' includes an ultrasonic transducer 0407 for outputting an ultrasonic signal. Non-limiting examples of suitable ultrasonic transmitters (including transducers) include, but are not limited to, miniature loudspeakers and piezoelectric buzzers.

[0256] Within the telecommunications device 0425, the ultrasonic signal may, for example, be received by the microphone 0429 of the device described on pages 34 / 51 of CN 120899266 A, such as a smartphone, personal digital assistant (PDA), tablet PC, pocket PC, notebook PC, desktop PC, and server PC.

[0257] The signal volume may be kept low to conserve power, although higher volumes are also possible because sound is...Inaudible. For example, the volume of the signal can be further increased at ultrasonic frequencies without worrying about the existence of an "audience," since the audience cannot hear the signal. Furthermore, the signal can be encoded to prevent other devices (not paired with the ultrasonic transmitting device) from receiving and understanding the signal.

[0258] As described above, a telecommunications device may include processing means configured by client logic (e.g., software) for receiving and processing ultrasonic signals. For example, software on a smartphone can decode ultrasonic signals. Data processing can provide additional information relevant to the user (including the type of information (e.g., the nature of biological parameters)). For example, a signal can be encoded such that (after the start identifier) ​​it contains: 8 pulses representing ECG data; 10 pulses representing a thermometer reading (e.g., the last 4 digits after the decimal point); 12 pulses representing a blood pressure reading (e.g., 3 digits of systolic pressure, 3 digits of diastolic pressure, and 3 digits of pulse rate); 14 pulses representing pulse oximeter data (e.g., 3 digits of O2sat and 3 digits of pulse rate); 16 pulses representing a blood glucose meter reading (e.g., 3 digits of blood glucose level); and so on. A "separator" can exist between the numbers and the EOM (End of Message) indicator. In practice, the signal can be sent multiple times, allowing for comparison and verification between received data.

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

[0260] In some variations, the signal may also include a segment of analog data (e.g., a time-varying signal, a distance-varying signal, etc.) for transmission along with digital information, which includes formatted analog data or information extracted from analog data (e.g., scaling). For example, a signal for transmission from an ultrasonic transmitter via ultrasound may include one or more digital portions and one or more analog portions. The digital portion may include information extracted from the analog signal, such as scaling (e.g., maximum and / or minimum values), duration, average, etc. Analog, digital, and analog and digital (mixed) signals may be encoded (including encryption encoding) and / or may include error correction codes.

[0261] As described above, the signal may have a time and / or date stamp. In some variations, the device or system may be configured to perform multiple measurements and transmit them in batches or bursts to a telecommunications device. For example, measurements may be taken at times t1, t2, etc., and the measurement results may be stored on a device (e.g., a thermometer, a blood glucose meter, etc.) and transmitted at a later time (tn) using ultrasound.The waves are transmitted to a telecommunications device (e.g., a smartphone, tablet, etc.). The data can be processed by the telecommunications device and / or uploaded to an external server, etc. (e.g., the cloud).

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

[0263] As described above, the raw signals from the sensor and the derived information can be displayed and stored locally on the smartphone, and transmitted to a web server via an Internet connection. The software on the web server can provide a web browser interface for real-time or retrospective display of signals and information received from the smartphone, and also includes further analysis and reporting.

[0264] As used herein, ultrasonic signaling generally refers to the transmission of information (such as the amplitude of biological parameters and the origin of biological parameter measurements, etc.) using ultrasonic signals. As described above, these ultrasonic signals can be encoded to allow transmission and processing. The encoded signals can then be converted into ultrasonic range by any suitable method. For example, one or more frequencies corresponding to various signal values ​​can be used, such as DTMF or DTMF frequency shifted to ultrasonic frequencies. Another example of signal conversion is the use of amplitude shift keying. Another example is the use of frequency shift keying. Another example is the use of phase shift keying. In some embodiments, such as CN 120899266 A on pages 35 / 51 of the specification, multi-frequency signaling, such as spread spectrum communication, or multi-frequency carrier signaling, can be used. An example of multi-frequency carrier signaling is specifying a predetermined set of frequencies separated by intervals (such as intervals between 40 Hz and 100 Hz, or intervals such as approximately 65 Hz, etc.) (e.g., between 20 kHz and 22 kHz, or between 20 kHz and 24 kHz, or generally between a lower limit of 19 kHz and 20 kHz and an upper limit of the Nyquist frequency equal to or slightly below the expected sampling rate of the receiver), and for each such frequency, a "1" bit is encoded as the presence of a carrier signal (such as a sine wave at that frequency), and a "0" bit is encoded as the absence of such a signal. The receiver of this multi-frequency signal can then perform a Fast Fourier Transform or other correlation techniques known in the art to identify whether the carrier is available at each relevant frequency and thereby infer a set of bits to encode the digital signal. In some embodiments of multi-frequency carrier signaling, for example when the signal is not sufficiently defined, multiple samples can be acquired over time and averaged, and the averaged signal can then be processed as described above. In some embodiments of multi-frequency carrier signaling, for example when the frequencies are sufficiently close to cause interference, a Viterbi decoder can be used to decode the bit pattern. Typically, techniques known to those skilled in the art of communications, particularly those concerning modulation and demodulation (e.g., modems), can be employed.Examples include various modem standards designated as Vx (where x is an integer) issued by the International Telecommunication Union (ITU) T Sector, the entire contents of which are incorporated herein by reference for all purposes.

[0265] In some embodiments, not on a telecommunications device (or outside of a telecommunications device), the server may perform signal analysis to determine coded data. In some embodiments, the signal may be stored at the server and made available to personnel for refinement of transmission and / or reception techniques.

[0266] As described above, signaling may be performed by a transmitter. The transmitter may include a hardware system containing a signal generator, such as a processing device, which is a digital signal processor connected to a memory (e.g., DRAM or SRAM, which may be integrated with the processing device in some embodiments), containing program instructions executable by the processing device and / or data used by the program. The transmitter may also include persistent memory such as flash memory coupled to and / or incorporated into the processing device. The signal generator may generate an ultrasonic signal to be transmitted as described above. In some embodiments, the waveform for transmission may be stored in persistent memory. In some embodiments, the transmitter includes a power source and / or a battery, or uses a power source for powering other components on the medical sensing device. As described above, the transmitter may include a transducer, such as a piezoelectric transducer that converts electrical pulses into ultrasonic vibrations. The transmitter may include an amplifier (directly or indirectly, such as via an audio digital-to-analog converter (DAC), which in some embodiments may be integrated with the processing device) coupled to the processing device, which provides electrical pulses to the transducer through its output. In some embodiments, the transmitter may include a real-time clock and / or a receiver for receiving broadcast time signals. In some embodiments, the transmitter may include an encryptor, which may be, for example, program instructions that execute on the processing device, or may be a separate integrated circuit. In some embodiments, the transmitter may include an error correction code generator and / or an error detection code generator, which may be, for example, software instructions that execute on the processing device, or may be a separate integrated circuit. The techniques described herein for transmitting and receiving acoustic signaling can be performed at the transmitter as described herein in a manner readily understood by those skilled in the art.

[0267] In some variations, the transmission from the medical sensing device to the telecommunications device is unidirectional, generally providing simplicity of design, lower cost, and lower power consumption, etc. These advantages are particularly useful when compared to systems where medical sensing devices include additional receivers (including microphones or antennas for receiving acoustic signals). However, in some configurations, medical sensing devices can be adapted to receive simple indicator signals from telecommunications devices without the need for additional receivers such as antennas or microphones. For example, in some variations, an ultrasonic transducer (e.g., a piezoelectric speaker) can be used as...A 20kHz sensor is used to implement a return acknowledgment (ACK). For example, a telecommunications device (e.g., a telephone) can generate a short 20kHz burst after receiving, decoding, and verifying the CRC to signal to the sensor that the telecommunications device has correctly received it, indicating that retransmission is not required. In other variations, the signal from the telecommunications device can indicate that the telecommunications device is ready to receive a transmission from the biometric measurement device. Paired or multiple timing signals / acknowledgments 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), thereby allowing the receiver to correct 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 transmitter (e.g., unidirectional). FEC can help ensure that data is received correctly.

[0269] In some embodiments, the data transmitted by ultrasonic signaling can be processed to include error correction codes, such as BCH codes, weighted codes, convolutional codes, group codes, Golay codes such as binary Golay codes, Goppa codes, Hadamard codes, Hagelbarger codes, Hamming codes, Latin matrix-based codes, dictionary codes, sparse graph codes such as low-density parity-check codes, LT or “fountain” codes, online codes, Raptor codes, Reed-Solomon codes, Reed-Muller codes, repeating cumulative codes, repeating codes such as trimodal 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 the receiver or at a server receiving communications from the receiver.

[0270] Example 1: Digital Thermometer

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

[0272] Typically, the device can capture data (e.g., thermometer temperature readings) and encode the data for use in ultrasound.Wave transmission. The encoded signal may include error checking (e.g., CRC encoding, Hamming code, etc.) and may be encrypted. For example, the data may be encrypted using, for example, the Advanced Encryption Standard (AES). U.S. Patent Nos. 5,481,255 and 5,452,356 both describe data encryption methods and techniques that can be used with the data described herein.

[0273] For example, data received from a thermometer may be encoded and / or encrypted into one or more data packets for transmission. A microprocessor may encode the data, which can then be transmitted by driving a piezoelectric speaker. As described above, frequency shift keying (FSK) may 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) may configure, encode, and encrypt the data, and may also control the transmission of prepared packets of encoded / encrypted data driven by a speaker (e.g., a piezoelectric transducer). The control logic may also control the timing of the transmission, such that there is sufficient interval between the data bits. Additionally, the control logic can repeat the transmission and time the start of the transmission.

[0274] For example, in one variation, a thermometer typically measures temperature, and once the temperature has stabilized at a certain value, the thermometer emits an audible beep to alert the user to read the value. The 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 ultrasonic 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 ultrasonic modem receiver logic.

[0275] In this example, the microprocessor may include the following (exemplary) code to implement the above-described functionality. Figures 23 and 24A through 24E illustrate flowcharts describing methods for transmitting data. These examples are not limited to digital thermometers but can be used with any device described herein (including ECG transmission).

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

[0277] One or more of the steps of the methods in Figures 23 and 24A through 24E may utilize the methods described herein.The process may be performed by a circuit (e.g., one or more of a processing device or logic circuit 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 memory.

[0278] In any system, apparatus or method described herein, data (including digital, analog and / or mixed digital / analog data) may be compressed before encryption. Any suitable data compression technique may be used. For example, lossy and / or lossless techniques may be used for data compression. Lossy and lossless data compression of known types may be used. For example, Lempel-Ziv (LZ) compression and other statistical redundancy techniques may be used for lossless compression. Similarly, lossy data compression techniques may also be applied. A receiver that performs control logic may decompress the data.

[0279] As described above, the receiver (digital ultrasound modem receiver) may be used to receive transmitted ultrasound signals. The receiver can be a dedicated device that includes a microphone assembly for receiving ultrasonic signals and a processing device (e.g., a microprocessor) capable of analyzing the signals, or the receiver can be a device with a microprocessor and a microphone adapted to receive ultrasonic signals while executing control logic (e.g., digital ultrasonic modem receiver logic).

[0280] For example, Figure 25 illustrates a variation of a flowchart for receiving, demodulating, and detecting digital ultrasonic signals. In this example, the application (receive control logic) receives binary FSK encoded data via a microphone input. For example, the input can come from a microphone on a smartphone. As mentioned above, binary FSK encoding uses two frequencies: the “signal” frequency Fr, representing binary 1, and the “space” frequency Fs, representing binary 0. In this implementation, no carrier wave is used.

[0281] The application consists of two largely independent components: a demodulator that extracts the sign and space frequency components from the raw audio data; and a packet decoder that monitors the demodulated signals used for packet transmission and decodes these demodulated signals. These are shown in Figure 25. The demodulator receives audio samples from the microphone hardware at a sampling rate S, such that S > 2*max (Fm9F8). The audio samples are processed by two frequency detectors that calculate the strength of the signal and space frequency components of the received signal (respectively). In this implementation, the Goertzel algorithm is used for frequency detection. To achieve sufficient frequency resolution between the signal and space frequencies, the Goertzel algorithm is applied to a sliding window of G samples, where G = S / abs(Fm-F).

[0282] The outputs of the Goertzel algorithm for the signal and space frequencies are passed to independent low-pass filters with a passband equal to the baud rate. The filtered output of the space frequency signal is then subtracted from the filtered output of the signal frequency signal. This produces a signal that is not...A waveform that is approximately 0 when transmission occurs rises to a positive value when the “signal” frequency is valid and falls to a negative value when the “blank” frequency is valid.

[0283] The demodulated waveform is then passed to the packet decoder. For each raw audio sample received from the microphone hardware, the demodulator generates a single demodulated sample of the demodulated waveform. The packet decoder receives the demodulated sample 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 these samples contain the synchronization sequence. A two-stage test is used: first, a computationally simple evaluation to eliminate most false alarms due to random noise, and then a more computationally expensive evaluation to eliminate the rest.

[0284] Once a valid synchronization sequence is received, the decoder stores the properties of the received signal (e.g., maximum sign / blank amplitude, etc.). These equalization parameters are used to calibrate the decoder thresholds used to read the remainder of the packet. The decoder, as described on pages 38 / 51 of this specification, CN 120899266 A, then reads each encoded byte sequentially. The decoder uses stored equalization parameters to determine the minimum amplitude threshold for the start bit of each byte. Once a valid start bit is received for a given byte, subsequent bits are evaluated based on the sign of the demodulated waveform if no minimum threshold for decoding is available.

[0285] If no valid start bit is received, the decoder stops reading packets and waits silent, or until a fixed amount of time has elapsed, before continuing to listen for new packets. Each logical byte in a packet is actually transmitted as two encoded bytes: the first byte contains the lower half-byte of the Hamming encoding of the logical byte, and the second byte contains the higher half-byte of the Hamming encoding.

[0286] The first logical byte read is the packet version checked against a supported version number. Next, the packet length, which specifies the number of subsequent data bytes, is read. If the packet length exceeds the maximum length of the specified packet version, the packet is rejected. Subsequently, each logical data byte is read.

[0287] After reading the data bytes, two logical checksum bytes are read, and the received checksum value is compared with the value calculated for the received data bytes. If the two checksum values ​​match, the packet is considered valid and can be used for the rest of the application. If the two checksum values ​​do not match, the packet is rejected. The two logical checksum bytes indicate the end of the packet. After receiving a packet, the decoder resumes listening for new packets.

[0288] Once the data is received (and decrypted in some variations), any communication capability of the telecommunications 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 smartphone and / or uploaded to a medical database for storage and / or later viewing.

[0289] Although the steps described above illustrate the method of transmitting data as shown in FIG25, 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.

[0290] One or more steps of the method of FIG25 may be performed using circuitry as described herein (e.g., one or more processing means or logic circuits of a computing device or its accessories). The processing means or logic circuits may be programmed to provide one or more steps of the method, and the program may include program instructions stored on a computer-readable memory or programming steps of the logic circuitry.

[0291] Although the examples above describe systems configured to transmit digital information, the techniques, apparatuses, and systems described herein may also be configured to transmit analog signals and / or mixed analog and digital signals. Typically, the described techniques include using a timer (e.g., in a microcontroller) to transmit signals to a piezoelectric element to generate ultrasonic signals. Alternatively, in some variations, the system uses a D / A converter to drive a speaker for non-digital output. Furthermore, in some variations, the output system is not a piezoelectric element, but a more conventional loudspeaker (although within the ultrasonic range). Additional digital-to-analog (D / A) conversion may occur during transmission.

[0292] For example, Figures 26A and 26B illustrate a variation of a hybrid digital / analog format that can be used with an ultrasonic transmitter. Typically, the signal may include digital components that are modulated or configured for transmission by an ultrasonic modem. For example, the digital signal may be encoded as an FSK signal, and the data (e.g., analog data such as biometric data like ECG, blood oxygen / pulse oxygenation, etc.) may be encoded as a frequency-modulated waveform appended to the digital information.

[0293] For example, in some variations, the ultrasonic transmitter is configured as a pulse oxygenation measurement / monitoring device. In this example, information obtained from pulse oxygenation can be examined to extract information such as minimum values, maximum values, analog signal duration, etc., and can be digitally encoded and placed in a buffer and / or transmitted ultrasonically (using one or more encryption and / or error correction codes). The analog signal may be combined with a digital signal (or extracted signal) that can be sent to the transmitting element and received by a telecommunications device. In an example of a device configured as a pulse oximetry device (e.g., a plethysmometer), the pulse oximetry device prepares a mixed data / analog signal by determining the peak value, minimum value, duration, time interval, etc., of the analog signal from an analog signal (e.g., a time-varying pulse oximetry signal). Therefore, the mixed signal may include extracted or labeled digital information as well as waveforms (or multiple waveforms) acquired from the device.

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

[0295] The signal may be transmitted encrypted via a device-specific or user-specific identification code. Generally, any device described herein may encode the data and may provide an encryption key so that it can be read and understood by a receiving telecommunications device (e.g., telephone, tablet, pad, etc.).

[0296] Transmitting a hybrid analog / digital signal that can be read and understood by a telecommunications device has many potential benefits. For example, if the hybrid signal comprises a series of values ​​(e.g., minimum / maximum values) and waveforms (e.g., ECG, heart rate, etc.), such a hybrid digital / analog system may allow for more efficient communication than just FSK value data.

[0297] For example, variations of ultrasound transmission devices may include pedometers, activity monitors, heart rate monitors, etc. In some variations, the signal is formatted such that a finite number of points exist in the analog portion. The ultrasonic transmitter can then send a series of data points (including any calibration points). In one example, a graph of heart rate could include 1,000 points over 2 seconds (transmission time) representing a graph of biometric data over time. The signal could include digital values ​​(e.g., encoded as FSK) and analog (e.g., graphical) data. This mixed signal could include the best characteristics of both digital-only and analog-only signals.

[0298] In one example, as mentioned above, the ultrasonic transmitter is a thermometer that includes the ultrasonic modem element described above. The ultrasonic thermometer device can be configured to include a temperature range of approximately 95°F and 106.7°C for practical use. Therefore, the temperature can typically be transmitted with a resolution of 0.1 (e.g., 120 values, so 8 bits may be all that is needed). In a device configured to encode biometric data in a mixed signal, a digital component of the signal can be appended first, and this digital component can include information relating to the analog signal following the digital-only signal, while the analog signal can be appended or embedded in the remainder of the signal, and the digital information can be extracted from the digital signal that includes digital information together. Examples of mixed signals may include a thermometer device as described above, which displays temperature as a function of time and measures and / or records and transmits maximum / minimum temperatures, measured times, etc., and the signal may also include a temperature waveform showing the time process. Other devices and / or signals (mixed signals) may include blood glucose monitoring signals (e.g., configuring an ultrasonic transmitter as a blood glucose meter, etc.), which may transmit blood glucose signals (including digital signals of maximum, minimum, etc.) and one or more graphs showing the waveform of blood glucose over time, etc.

[0299] Preparing and transmitting signals 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 transmitter applies a specific sampling rate (e.g., 300 or 500 samples / second, where each value is a 16-bit binary value). More data can be sent efficiently as a waveform in compressed form. Including extracted information (such as the minimum and maximum values ​​of the analog signal) in the digital portion of the signal can provide axis calibration for the analog portion of the signal for, for example, display.

[0300] As mentioned, Figure 26A illustrates a variation of a hybrid digital / analog 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 appropriately 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, the signal includes a start bit or byte 0905, a calibration data sequence 0907 extracted from the analog signal (e.g., maximum / minimum value), and additional data 0909 on the analog signal (e.g., type, timing, data stamp / time stamp, etc.). Any other digital information may be included. Later, the signal may include an analog component 0903. In Figure 26A, the analog signal is slightly open and can be sustained for a fixed or variable duration; in some variations, the entire signal can be repeated to allow reception by a telecommunications device. Figure 26B shows a similar variation of the mixed signal format, where a digital component 0901 is appended to the analog component 0903, and an additional digital component 0911 (“end” signal) can be appended at the end. In some variations, multiple analog components can be combined with multiple analog components. As described below, the entire signal can be encrypted before transmission.

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

[0302] In any device, system, and method described herein, the ultrasonic signals transmitted by the device can be encrypted. Any suitable encryption method can be used, including encryption methods using keys, such as Data Encryption Standard (DES) and Advanced Encryption Standard (AES), etc.

[0303] Typically, the encryption key for a particular device (e.g., ultrasonic transmitting device) can be presented on the device (or...)The encryption key is displayed on the associated packaging, housing, etc. of the device, so that the encryption key can be easily accessed by the user of the receiving telecommunications device. The encryption key can be prepared as a barcode or other machine-readable format (e.g., QR code), and in particular, a readable format that can be read by the receiving telecommunications device in a different modality than ultrasonic transmission. As used herein, reference to presenting or displaying the encryption key on an ultrasonic transmission device is intended to include displaying the prepared representation (in particular a machine-readable representation) on the ultrasonic transmission device, its packaging or associated structure (e.g., housing, etc.). In some variations, the encryption key is prepared as a barcode or QR code and printed on the exterior of the ultrasonic transmission device, so that the encryption key can be photographed or scanned by the telecommunications device. The machine-executable logic on the telecommunications device (e.g., client logic, software, firmware, etc.) can then determine the encryption key and apply the encryption key to decrypt the ultrasonic signals received from the ultrasonic 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. Therefore, in some variations, each ultrasonic transmitting device may have a unique ID printed on the device, thus 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 schematically illustrates a variation of a system including an ultrasonic transmitting device (“source device” 01031) having an encryption key 01051 visible on the body of the device, which can be read and applied by the telecommunications device 01025 to decrypt the transmitted ultrasonic waves. Figure 27 also illustrates a variation of the device and system in which the ultrasonic transmitting device (“source device” 01031) communicates bidirectionally (or partially bidirectionally) with the telecommunications device.

[0306] As described above, communication between a telecommunications device (e.g., a smartphone or computer) and an ultrasonic transmitting device (such as a healthcare / fitness sensing device, home automation and security device (door and window sensors, remote light switches, etc.), factory water level detector, etc.) can be useful. For example, implementing a half-duplex protocol would be helpful, allowing a telecommunications device (e.g., a smartphone / computer) to provide an acknowledgment (ACK) to a sensing device (source device or ultrasonic transmitter) that data has been successfully received (with a correct CRC) and to stop retransmitting the data. Another use of this half-duplex protocol would be to configure a remote device by sending parameters or information (such as calibration data, personal information, etc.) from the telecommunications device.

[0307] For simple verification, a piezoelectric / speaker used by the device (ultrasonic transmitter) to transmit data can be used as a frequency tuning sensor. Typically, a piezoelectric element used to transmit sound can also be configured as a receiver. Using a piezoelectric element asTo receive the sensor, a relatively “loud” signal is required (even if the signal is inaudible), so the signal should be at the resonant frequency of the most sensitive piezoelectric element. The duration or encoding of this “frequency burst” can be configured so that it can be easily identified by the low-power electronics of the body sensing device. For example, a confirmation pulse can be filtered and detected as the presence of only a specific ultrasonic frequency for a predetermined duration.

[0308] In some variations, symmetrical bidirectional communication can be achieved using established telephone modem technology, thereby 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 (Frequency Shift Keying). These telephone modem technologies assume that only two devices are attempting to communicate. Radio frequency protocols can be used to enhance the modem protocol to allow multiple devices to communicate simultaneously without errors.

[0309] Implementation of such bidirectional communication technology can include additional processing capabilities in the device sufficient for signal processing required to demodulate and decode the received audio. Such processing capabilities may require additional battery power and physical space in the device. A partial list of existing modem communication standards suitable for ultrasonic communication may include ITU V.21 (300bps, FSK) and ITU V.22 (1200bps, PSK (Phase Shift Keying)). For example, see 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_Jinkinds.pdf.

[0316] Regarding Figure 27, the source device may include an additional transducer / microphone for receiving ultrasonic signals from a telecommunications device.The signal and support processing (e.g., microprocessor / microcontroller logic) for controlling ultrasonic signals, interpreting communications (which may be coded and / or encrypted), and performing any command functions. Similarly, telecommunications devices may include a loudspeaker (piezoelectric element) configured to emit ultrasonic signals.

[0317] Based on the above description, it is clear that the currently disclosed and claimed (one or more) inventive concepts are well suited to achieving the purposes mentioned herein and obtaining the advantages mentioned herein, as well as the advantages inherent in the currently disclosed and claimed (one or more) inventive concepts. Although the presented embodiments have been described for the purposes of the invention, it should be understood that many changes can be made, which will be readily apparent to those skilled in the art and done within the spirit of the currently disclosed and claimed (one or more) inventive concepts.

[0318] Example 2: Heart Rate Monitor Using Audio Tone for Heart Rate Transmission

[0319] Any apparatus, system, and method described herein can be configured as a wireless (ultrasonic) heart rate monitor compatible with mobile telecommunications (computing) devices (such as smartphones). 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 detected ECG signals). Wearable components for sensing heart rate (e.g., wearable monitors) can be configured as wristbands, anklets, armbands, chest straps, waist belts, etc. (collectively, “bands”) and can wirelessly transmit information via any of the above-described ultrasonic methods (including using receive control logic (e.g., software, hardware, etc.) to receive, store, and / or analyze the sensed (biometric) information).

[0320] Most heart rate monitors consist of a chest strap that incorporates an ECG amplifier, an R-wave detector, and circuitry for outputting a typically 50 ms wide 5 kHz electromagnetic pulse when an R-wave is detected. This electromagnetic pulse is detected by a watch or other receiver, which then measures the interval between the pulses and calculates and displays the heart rate. This configuration requires a special receiver that may not be present in a mobile phone or computer, so without additional equipment, the mobile phone or computer cannot receive heart rate information. This range is also limited to approximately 1 meter because near-field electromagnetic transmission is typically used.

[0321] In one variation of the apparatus and system described herein, the heart rate monitor may include a band (e.g., a chest strap, wristband, etc.) incorporating an ECG amplifier, an R-wave detector, and circuitry for outputting an audio duration (signal) typically 5 ms wide when an R-wave is detected (e.g., in the ultrasound frequency range of approximately 17 kHz to 30 kHz). This audio tone can be detected by a device such as a smartphone or other mobile computing device using a built-in microphone on the smartphone device, and then...The intervals between tones are measured and the heart rate is calculated and displayed. Mobile computing devices (e.g., telephones) may include software, firmware, or hardware (though typically software, including applications or "apps" downloadable from remote servers) for controlling the mobile device to receive and analyze audio (e.g., ultrasound) tones, calculate heart rate, and store, upload, and / or display heart rate.

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

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

[0324] In some variations, the apparatus, method, and system can be configured such that multiple heart rate monitors can be used in close proximity, or a single receiving device can simultaneously receive heart rate information from multiple users. It may be desirable that the heart rate information from each heart rate monitor is uniquely identifiable, and therefore does not interfere with each other.

[0325] For example, the audio tone 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 combinations thereof.

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

[0327] Therefore, each heart monitor need not be set to a specific tone frequency; the frequency can be determined by a pseudo-random sequence when the heart monitor first detects an R-wave heartbeat signal after being first worn. The audio tone is then fixed until the heart monitor is removed. Therefore, each monitor does not need to be uniquely coded.

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

[0329] The pseudo-random allocation of the frequency to be used can be achieved by having a counter that increments over time from when the heart monitor is first attached to the body, such that the counter value when the first R wave is detected determines the audio frequency to be used. The audio frequency can be changed by removing and reattaching the monitor to the body.

[0330] In the example above, it is possible that two heart monitors are using the same frequency and are very close to each other.In rare cases where interference is possible, the frequency of a monitor can be changed by removing and reattaching it. The receiving device can also detect such interference and, if necessary, advise the user to remove and reattach the monitor.

[0331] The receiving device can determine the audio pitch frequency of a particular ultrasound transmitting device (in this example, a heart monitor) by performing spectral analysis of the received audio. Once the audio pitch frequency is known, a narrow audio filter is used to separate the pitches from each heart monitor. The audio pitches can then be detected, and the heart rate can be calculated by measuring the intervals between the audio pitches. Since the duration of each audio pitch is fixed, this information can be used to suppress interference from other audio sources in the frequency band. Specification 43 / 51 pages 46 CN 120899266 A

[0332] A second embodiment is an embodiment in which multiple devices (e.g., heart rate monitors) use audio pitches of the same frequency but with different durations. The duration of each pitch can be measured by the receiving device. Only pitches of a specific duration are used to calculate the heart rate of a particular heart rate monitor. In cases where two heart rate monitors are close enough that the receiving device picks up audio tones from both monitors simultaneously, differentiation can be made between them based on the duration of the tones. Audio tones are unlikely to arrive simultaneously because the duration of the tones is relatively short compared to the interval between the tones (heart rate interval), but if the audio tones do arrive simultaneously, this can be identified by the receiving device, and the heart rate calculation can be adjusted to compensate for it.

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

[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 generating an audio signal (e.g., one or more pulses) timed with the patient's heart rate. Therefore, the monitor acts as an audio repeater. The audio signal can be within the ultrasonic range. The system may also include control logic to control a mobile device, such as a smartphone or tablet, to receive and analyze audio signals timed with the user's pulse rate. In some cases, a dedicated receiver may be used instead of a smartphone running the control logic, or in addition to a smartphone running the control logic.

[0335] In a particular example, the system may include an application for use on a mobile device, such as a smartphone, which controls the smartphone to use an internal audio pickup (microphone) to receive audio signals emitted by sensors and calculate heart rate based on the audio (e.g., ultrasound) pulse signals.

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

[0337] Figures 28A and 28B illustrate another variation of a wearable device that can detect health parameters and transmit them ultrasonically to a monitoring station (e.g., a smartphone) controlled by control logic, such that the monitoring station receives information from the wearable device and / or induces the reception of information using ultrasonic waves.

[0338] Figure 28A shows an external view of a variation of the device configured as a wristband. The device may include one or more sensors for detecting bio-parameters, such as motion / vibration sensors, and one or more electrodes, etc. In Figure 28A, the outer surface of the device is schematically shown. A first conductive (e.g., metallic) window 01151 is visible on the outer surface of the wristband, and a second conductive (e.g., metallic) window 01153 is visible on the inner surface of the wristband. These electrodes allow a user to press down on the electrodes and the wristband to make skin-electric contact. The inner electrode can be in constant or periodic contact during normal use. The conductive windows may also be thermally conductive and may also be connected to a temperature sensing module.

[0339] The wristband may be flexible, allowing it to extend and be secured to the wearer's wrist. The wristband may be bendable, holding in place once bent around the wearer's wrist. In some variations, the wristband is open; in others, it may be closed (forming a closed loop on the subject's wrist). The outer surface of the wristband may be sealed to the inner surface to prevent damage and to make the wristband sweat- and water-resistant when worn.

[0340] As shown above with respect to the conductive window area, the outer portion of the wristband may be adapted to transmit energy from the module within the wristband through an outer protective housing. For example, the conductive window area is shown above. The area of ​​the wristband covering the ultrasonic transducer 01184 may also be adapted to allow ultrasonic signals to pass through. In some variations, the ends of the wristband are adapted to allow ultrasonic signals to pass through by including relatively rigid end caps that can readily convert ultrasonic energy. In some variations, the outer (e.g., polymer) covering is made of a relatively ultrasonically permeable material known in the art. In some variations, the end regions (or opposite end regions) may also be adapted to allow recharging of the device's battery.

[0341] FIG28B illustrates an exemplary internal schematic diagram of a wristband showing an internal module (structure). As described above, any suitable sensor (one or more) may be included, including any of the sensors described above. In this example, the wristband includes a motion sensor 01186, which may be a high-precision motion sensor for tracking body movement. Other sensors in this example include a first electrode 01191 and a second electrode that may be electrically connected to conductive windows 01151, 01153 on the outer surface.01192. In some variations, the outer surface is (one or more) an electrode. In other variations, the conductive surface (e.g., for the lower electrode) extends along the length of the inner surface of the wristband, such that it may come into 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 may extend entirely around the outer (outward-facing) surface of the wristband. Additional sensors may be included or omitted. For example, in one variation, the wristband includes only a motion sensor but not electrodes.

[0342] In some variations, the wristband also includes a haptic feedback element, namely a vibration motor 01194. The vibration motor may generate an oscillation frequency to provide feedback from the device to the user. In some variations, the wristband may also include a button or contact area that allows the user to manually trigger one or more functions of the wristband and / or monitoring station (such as transmitting data via ultrasound). The button may be pressed or activated by a protective outer cover of the wristband, and the outer cover may indicate where the button can be pressed by a pattern or color, etc.

[0343] The wristband may also include a processing device 01183 for receiving and / or encoding information from one or more sensors, and an ultrasonic transducer 01184. As discussed above, the transducer can receive encoded / encrypted information from the processing device for transmission 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) may also be included to store recorded information. The memory may be integrated with the processing device. In some variations, a separate ultrasonic detector 01194 may also be used, or the ultrasonic transducer 01184 may be a component capable of transmitting and receiving ultrasonic signals. Thus, bidirectional communication via ultrasound is possible between the device and a monitoring station (e.g., a smartphone running control logic).

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

[0346] In operation, the wristband can be worn and used to monitor the subject (e.g., body activity) and can record and / or wirelessly transmit the subject's sensed values. For example, motion sensor data can be detected by ultrasound and transmitted to a mobile computing device (e.g., a smartphone 01130). As discussed above, the sensed data can be encoded (e.g., as analog and digital information) and encrypted, which can prevent interference between other devices (e.g., allow specific keying between devices) and also allow error correction.

[0347] For example, a wristband device (e.g., an activity monitor) can be worn by the subject. When the wristband device is worn, the device can record the wearer's movement (activity). The device may also include additional sensors such as a pair of electrodes. When the subject presses down on the outer surface of electrode 1, these electrodes can be used to measure ECG on the patient (e.g., between the patient's arms). In some variations, pressing may also trigger the device to record potentials during that time period. The recorded electrical signals may include information related to the pulse and ECG, which may be transmitted directly on the processing device or initially analyzed by the processing device and then transmitted on the processing device (including transmitting any analyzed information).

[0348] The device may be configured to transmit data continuously (e.g., via ultrasound broadcast) and / or repeatedly, or it may be configured to shake hands with a smartphone (or other receiving station). For example, the wristband device may be configured to standby until the ultrasound transducer / detector (01184 / 01194) receives an ultrasound trigger ('ready'). The wristband can then communicate with the receiving station instruction manual, pages 45 / 51, 48 CN 120899266 A, to transmit the collected data via ultrasound encoded / encrypted as described above. The system can be configured to transmit periodically or attempt to transmit when sufficient data has been collected.

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

[0350] Example 3: ECG Detection Wristwatch

[0351] Figures 29 and 30 show another variation of an ECG measuring device configured to detect ECG signals and transmit ultrasound signals that encode ECG data. In this example, the watch has been modified to include two electrodes. The first electrode (not visible in Figures 29 and 30) is located on the back of the watch (“wristband”) and contacts the wrist of the person wearing the device. As shown in Figure 29, the second electrode 01203 is located on the “front” of the watch 01201. Therefore, a 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] The watch may also include one or more controls and / or indicators. For example, the watch may also be configured as a clock (showing time, etc.). The watch may include buttons, dials, etc., to select functions (e.g., turning ECG reading on / off, starting ECG information transmission, etc.).

[0353] Figure 30 shows a variation of the ECG device 01203 shown in Figure 29 transmitting to a mobile telecommunications device 01205. In this example, the mobile telecommunications device is a smartphone (iPhone™) configured to act as a receiving station for 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 ultrasound signal. The receiving device (smartphone) can then process the signal and display it in real time as shown in Figure 30 while ECG signals are being recorded. In this example, the smartphone is continuously receiving, displaying, and recording signals.

[0354] As described above, the signal can be processed before being displayed and / or stored and / or transmitted. For example, the signal can be filtered to remove artifacts and / or smoothed. The signal can also be analyzed to automatically detect cardiac events (e.g., arrhythmias). Processing can be performed before, after, or between the ultrasonic transmission from the watch and the receiving device (e.g., the 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 may be used. The watch may broadcast ECG data continuously, or the watch may transmit only when the receiver indicates that it is ready to receive; in such variations, the device may store the detected ECG data for later transmission.

[0356] In the examples shown in Figures 29 and 30, the system also determines the heart rate based on the ECG information. Additional information may also be extracted from the signal. As described above, the signal may be transmitted by the device (e.g., a wristband) as a digital, analog, or mixed digital / analog ultrasound signal. Furthermore, the signal may 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] Although many of the exemplary devices described herein are wearable devices (e.g., wristbands, chest straps, pendants, jewelry, etc.), the principles, modules, subsystems, and elements 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 encoding of ultrasonic signals or encoding 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 herein as being “on” another feature or element, that feature or element can be directly on the other feature or element, or there may be intermediate features and / or elements present. Conversely, when a feature or element is referred to as “on”...When a feature or element is attached to another feature or element, there is no intermediate feature or element. It should also be understood that when a feature or element is referred to as “connected,” “attached,” or “coupled” to another feature or element, the feature or element may be directly connected, attached, or coupled to the other feature or element, or there may be intermediate features or elements. Conversely, when a feature or element is referred to as “directly connected,” “directly attached,” or “directly coupled” to another feature or element, there is no intermediate feature or element. Although one embodiment has been described or illustrated, the features and elements so described or illustrated may be applied to other embodiments. Those skilled in the art will also understand that references to structures or features arranged “adjacent” to another feature may have portions that overlap with or are below the adjacent feature.

[0359] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the invention. For example, as used herein, unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” are intended to also include the plural forms. It will be further understood that the terms “comprises” and / or “comprising”, when used in this specification, specify the presence of the stated feature, step, operation, element, and / or component, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items and may be abbreviated to “ / ”.

[0360] Spatially relative terms such as “below,” “below,” “lower,” “above,” and “upper” may be used herein to facilitate the description of the relationship between one element or feature as shown in the figures and (one or more) another element or feature. It should be understood that, in addition to the orientation shown in the figures, spatially relative terms are intended to cover different orientations of the device in use or operation. For example, if the device in the figures is inverted, it is described as being “below” other elements or features. Or, an element “below” will be oriented “above” other elements or features. Thus, the exemplary term “below” can encompass both upward and downward orientations. Devices can be oriented in other ways (rotated 90 degrees or in other orientations), and the spatial relative descriptors used herein will be interpreted accordingly. Similarly, unless otherwise specifically stated, the terms “up,” “down,” “vertical,” and “horizontal,” etc., are used herein for illustrative purposes only.

[0361] Although the terms “first” and “second” may be used herein to describe various features / elements, these features / elements should not be limited by these terms unless the context otherwise indicates. These terms can be used to distinguish one feature / element from another. Therefore, without departing from the teachings of the invention, the first feature / element discussed above is considered...The element may be referred to as a second feature / element, and similarly, the second feature / element discussed above may be referred to as a first feature / element.

[0362] As used herein in the specification and claims (including as used in the examples, and unless otherwise expressly stated), all numbers may be interpreted as beginning with the words “about” or “approximately”, even if the term is not explicitly stated. The phrase “about” or “approximately” may be used when describing size and / or location to indicate that the described value and / or location is within a reasonably expected range of value and / or location. For example, a numerical value may have values ​​of + / - 0.1% of the value (or value range), + / - 1% of the value (or value range), + / - 2% of the value (or value range), + / - 5% of the value (or value range), + / - 10% of the value (or value range), etc. Any numerical range described herein is intended to include all subranges included therein.

[0363] Although preferred embodiments of the invention have been shown and described herein, it will be apparent to those skilled in the art that these embodiments are provided by way of example only. Many variations, alterations, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein can be used to practice the invention. The appended claims are intended to define the scope of the invention and thereby cover the methods and structures within the scope of these claims and their equivalents.

[0364] FIG31 is a flowchart of a method for performing a 12-lead ECG using a three-electrode device according to some embodiments of the invention. Pages 47 / 51 50 CN 120899266 A 3101. Method 3101 may be performed by processing logic including hardware (e.g., circuitry, dedicated logic, programmable logic, microcode, etc.), software (e.g., instructions running on a processing device to perform hardware emulation), or combinations thereof. In one embodiment, the processing logic corresponding to one or more components or methods of FIG1 to FIG30 may perform one or more of the following operations. For example, in one embodiment, the processing logic of processing device 1110 performs the following operations with respect to the various components and operations of FIG1 to FIG30. In another embodiment, any other suitable processing device may perform the described operations.

[0365] Referring to FIG. 31, at block 3103, the processing logic can determine lead I (value) based on a first electrical signal from the first electrode and a second electrical signal from the second electrode. Lead I can be calculated according to any method described herein. For example, lead I can be calculated based on electrical signals from a first electrode of a first upper limb contacting the user and a second electrode of a second upper limb contacting the user. At block 3105, the processing logic can determine the lead based on the second electrical signal and a third electrical signal from a third electrode.II. In one embodiment, lead II can be calculated according to any of the methods described herein. For example, lead II can be calculated based on electrical signals from a second electrode contacting the user's second upper limb and a third electrode contacting the user's first lower limb. In one embodiment, lead I and lead II are measured sequentially (e.g., the user first places the electrode of lead I, obtains a measurement result, and then places the electrode of lead II and obtains the corresponding measurement result). 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 of lead I and lead II, and obtains the two 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 the electrical signals of the electrodes contacting the user. At block 3109, the processing logic may be used by the processing device to determine leads aVR, aVL, aVF, V1, 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. 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 FIG32, the model may use additional data.

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

[0368] At block 3111, the processing logic can provide leads, namely leads I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6, for display on the client device. In another embodiment, a subset of twelve leads may be provided (or no twelve leads may be provided).

[0369] In one embodiment, the machine learning model is built based on a deep convolutional structure. The input layer processes the multi-lead ECG as a spatial image, with one dimension for the time axis and another dimension for multiple channels. The ECG channels may have a regular order of leads I, II, III, aVR, aVL, aVF, V1-V6. Alternatively, the ECG channels may have a grid called "Cabrera".A more physiologically meaningful sequence of “formula”, in which the order of the frontal plane leads is leads aVL, I, -aVR, II, aVF, III, V1-V6. In another input format, only Cabrera format limb leads and one actual measured precordial lead are used to form the input ECG image.

[0370] Instead of the 1D convolutional model used by most other ECG training models, 2D convolutional layers can be used to process the input ECG image. The training model may include 4 to 10 convolutional / residual layer blocks, followed by 2 to 4 fully connected layers. The output layer is a multi-class layer that may identify 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 using a large labeled training set with many periods. 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 overtraining during the training process. The test set is used for final performance checking. A dataset is first formed using an existing 12-lead diagnostic ECG database. And a second dataset will be formed from actual sampled ECGs from the target device described herein. Transfer learning can be used to adjust only a few layers of the deep learning model on the second dataset.

[0372] Figure 32 is a flowchart of a method 3201 for machine learning training of a 12-lead ECG using a three-electrode device according to some embodiments of the present invention. Method 3201 may be performed by processing logic including hardware (e.g., circuitry, dedicated logic, programmable logic, microcode, etc.), software (e.g., instructions running on a processing device to perform hardware simulation), or a combination thereof. In one embodiment, the processing logic corresponding to one or more components or methods of Figures 1 to 30 may perform one or more of the following operations. For example, in one embodiment, the processing logic of processing device 1110 performs the following operations with respect to the various components and operations of Figures 1 to 30. In another embodiment, any other suitable processing device may perform the described operations.

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

[0374] Optionally, at block 3203, the processing logic may preprocess the 12-lead ECG data before using it to train a machine learning model to classify the data based on at least one of height, sex, weight, and nationality. By preprocessing in this way, the model can be trained more efficiently to provide more accurate results specific to the user whose 12-lead ECG is being determined. For example, the processing logic may classify the 12-lead ECG data based on individual characteristics (3205). In one embodiment, if the individual is identified as male, the 12-lead ECG data may be preprocessed to include only the data corresponding to male subjects. In another embodiment, if the individual is identified as having a specific nationality, the data may be preprocessed to include only that specific nationality. Using such preprocessed data to train the model can allow for faster model training and provide more accurate results than previously possible without such preprocessing.

[0375] In one embodiment, features of the 12-lead data may be selected, extracted, and labeled, for example, by performing one or more machine learning operations, to predict the 12-lead ECG from three leads in real time. Such operations can be selected from operations such as ranking (one or more) features, classifying (one or more) features, labeling (one or more) features, predicting (one or more) features, and clustering (one or more) features. Alternatively or in combination, the extracted features can be labeled and saved for offline training of machine learning algorithms or sets of machine learning operations. For example, 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 ECG from three leads. These can include decision tree learning using methods such as random forests, association rule learning, artificial neural networks, inductive logic programming, support vector machines, clustering, Bayesian networks, reinforcement learning, representation learning, similarity and metric learning, or sparse dictionary learning, etc.

[0376] Machine learning-based algorithms or operations for predicting 12-lead ECG from three leads can be provided as a service from a remote server that can interact or communicate with a client program (e.g., as a mobile app) set on a user's computing device. The interaction or communication can be through an application programming interface (API). For example, an API can provide access to machine learning operations for ranking, clustering, classifying, and predicting 12-lead ECGs from three leads. (Specification 49 / 51, page 52, CN 120899266 A)

[0377] Machine learning-based algorithms or operations provided on remote servers and / or local applications on local computing devices can be manipulated, learned, and analyzed for prediction, for example, 12-lead and / or three-lead data from a user population.

[0378] The comparisons and analyses described herein can be used to draw conclusions and insights into a patient’s health status, including potential health problems the patient may experience at the time of measurement or in the future. Conclusions and determinations can predict future health conditions or diagnose conditions the patient already has. Conclusions and determinations can also include insights into the effectiveness or risk associated with medications or drugs that the patient may be taking, has taken, or may consider taking in the future. Additionally, comparisons and analyses can be used to identify behaviors and activities that may reduce or increase the risk of adverse events. Based on the comparisons and analyses described herein, ECG data can be categorized according to the risk level of adverse events. For example, ECG data can be categorized as normal, low risk, intermediate risk, high risk, and / or abnormal. Normal and abnormal designations may require evaluation, diagnosis, and / or confirmation by healthcare professionals.

[0379] Diagnoses and determinations of abnormalities, adverse events, or disease states by physicians and other healthcare professionals can be transmitted to servers and databases to be tagged with and associated with the 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 the patient's electronic health record, entered into the system by the patient, or entered into the system by a healthcare professional. The system's conclusions and determinations can be compared with actual diagnoses and determinations from healthcare professionals to validate and / or refine the machine learning algorithms used by the system. The occurrence time and duration of abnormalities, adverse events, or disease states can also be included in the database, allowing ECG data corresponding to their occurrence and / or ECG data before and / or after the abnormality, adverse event, or disease state to be correlated and analyzed. The length of time before or after the abnormality can be predetermined and can range from 1 to 30 days or more than 1 to 12 months. Analysis of the time prior to the abnormality, adverse event, or disease state allows the system to identify patterns or correlations of various ECG characteristics prior to the occurrence of the 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 the abnormality, adverse event, or disease state can provide information related to treatment efficacy and / or provide patients or physicians with information related to disease progression, such as whether the patient's condition has improved, worsened, or remained unchanged. Diagnosis and determination can also be used for indexing, for example, by including it in metadata associated with the corresponding ECG data.

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

[0381] Conclusions, determinations, and / or insights about a 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 automatically generated by the system can be sent to the patient. The email or text message may be a notification instructing the patient to log in to a secure site to retrieve the full conclusion, determination, or insight, or the email or text message may include the conclusion, determination, or insight. Alternatively or additionally, the email or text message may be sent to the patient's caregiver. Notifications may also be provided via applications on smartphones, tablets, laptops, desktop computers, or other computing devices.

[0382] As described herein, the system can identify behaviors, habits, activities, foods, beverages, medications, and drugs associated with a patient's abnormal ECG readings. In addition to notifying the patient of these associations, the system may also provide the patient with instructions or suggestions to avoid these behaviors, habits, activities, foods, beverages, medications, and drugs associated with the patient's abnormal ECG readings. Similarly, the system can identify behaviors, habits, activities, foods, beverages, medications, and drugs associated with normal or improved ECG readings, and can instruct or recommend patients to perform these behaviors, habits, and activities and / or consume these foods, beverages, medications, and drugs. Patients can avoid future healthcare problems by modifying their behaviors, habits, or by taking any action process as instructed or recommended by the system, including but not limited to taking medications, drugs, or adhering to a diet or exercise plan. This action process can be a predetermined action process recommended by the system, independent of any analysis of ECG data, and / or it can be generated from insights learned through the system and methods described herein. In addition, the system's insights can relate to general health and / or mental health.

[0383] The ECG data and associated metadata, as described herein, and other relevant data can be stored in a central database, a cloud database, or a combination of both. The data can be indexed, searched, and / or sorted according to any of the characteristics, parameters, or criteria described herein. The system can analyze ECG data from a single patient, and it can also analyze ECG data from a group of patients selected based on any of the characteristics, parameters, or criteria described herein. When analyzing data from a single patient, it may be desirable to reduce and / or correct for intra-individual variability in ECG data, such that a comparison of one set of ECG data acquired at one time with another set acquired at another time reveals differences caused by variations in health status rather than the type of ECG recording device used, variations in lead and electrode placement, and variations in skin condition (i.e., dryness, sweating, application or absence of conductive gel), etc. As mentioned above, consistent leads and...Electrode placement can help reduce variability in ECG readings. The system can also retrieve ECG data from patients acquired in similar circumstances and can analyze that 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. Instruction Manual Page 51 / 51 54 CN 120899266 A Figure 1 Instruction Manual Appendix 1 / 39 Page 55 CN 120899266 A Figure 2A Figure 2B Figure 2C Instruction Manual Appendix 2 / 39 Page 56 CN 120899266 A Figure 2D Figure 2E Figure 2F Instruction Manual Appendix 3 / 39 Page 57 CN 120899266 A Figure 2G Figure 2H Figure 2I Instruction Manual Appendix 4 / 39 Page 58 CN 120899266 A Figure 2J Figure 2K Figure 3A Instruction Manual Appendix 5 / 39 Page 59 CN 120899266 A Figure 3B Figure 3C Figure 3D Instruction Manual Appendix 6 / 39 Page 60 CN 120899266 A Figure 3E Figure 3F Figure 4A Instruction Manual Appendix 7 / 39 Page 61 CN 120899266 A Figure 4B Figure 4C Figure 5A The following are figures from the instruction manual: Figure 8 / 39, page 62, CN 120899266 A, Figure 5B, Figure 5C; Figure 9 / 39, page 63, CN 120899266 A, Figure 6; Figure 10 / 39, page 64, CN 120899266 A, Figure 7; Figure 11 / 39, page 65, CN 120899266 A, Figure 8, Figure 9A; Figure 12 / 39, page 66, CN 120899266 A, Figure 9B, Figure 9C, Figure 9D, Figure 10A; Figure 13 / 39, page 67, CN 120899266 A, Figure 10B, Figure 10C, Figure 10D, Figure 11A; Figure 14 / 39, page 68, CN 120899266 A, Figure 12A; Figure 15 / 39, page 69, CN 120899266 A, Figure 12B, Figure 12C, Figure 13A. Instruction manual drawings, page 16 / 39, 70 CN 120899266 A, Figure 14A; Instruction manual drawings, page 17 / 39, 71 CN 120899266 A, Figure 15A; Instruction manual drawings.Page 18 / 39, 72 CN 120899266 A, Figure 15B, Figure 15C, Instruction Manual Drawings; Page 19 / 39, 73 CN 120899266 A, Instruction Manual Drawings; Page 20 / 39, 74 CN 120899266 A, Figure 17, Instruction Manual Drawings; Page 21 / 39, 75 CN 120899266 A, Figure 18, Figure 19, Instruction Manual Drawings; Page 22 / 39, 76 CN 120899266 A, Figure 20, Instruction Manual Drawings; Page 23 / 39, 77 CN 120899266 A, Figure 21A, Instruction Manual Drawings; Page 24 / 39, 78 CN 120899266 A, Figure 21B, Instruction Manual Drawings; Page 25 / 39, 79 CN 120899266 A, Figure 21C, Instruction Manual Drawings; Page 26 / 39, 80 CN 120899266 A, Figure 22. Instruction manual illustrations, pages 27 / 39, 81 CN 120899266 A, Figure 23; Instruction manual illustrations, pages 28 / 39, 82 CN 120899266 A, Figure 24A; Instruction manual illustrations, pages 29 / 39, 83 CN 120899266 A, Figure 24B, Figure 24C; Instruction manual illustrations, pages 30 / 39, 84 CN 120899266 A, Figure 24D, Figure 24E; Instruction manual illustrations, pages 31 / 39, 85 CN 120899266 A, Figure 25; Instruction manual illustrations, pages 32 / 39, 86 CN 120899266 A, Figure 26A, Figure 26B; Instruction manual illustrations, pages 33 / 39, 87 CN 120899266 A, Figure 27; Instruction manual illustrations, pages 34 / 39, 88 CN 120899266 A, Figure 28A, Figure 28B; Instruction manual illustrations, pages 35 / 39, 89 CN. 120899266 A Figure 29 Instruction Manual Appendix Page 36 / 39 90 CN 120899266 A Figure 30 Instruction Manual Appendix Page 37 / 39 91 CN 120899266 A Figure 31 Instruction Manual Appendix Page 38 / 39 92 CN 120899266 A Figure 32 Instruction Manual Appendix Page 39 / 39 93 CN 120899266 A Abstract Abdominal ultrasound examination method, system and device ELECTRODE DEVICE Abstract: Anapparatus includes an electrocardiograph device having a first electrode assembly, a second electrode assembly, and a third electrode assembly, and the first electrode assembly, the second electrode assembly, and the third electrode assembly have a first electrode, a second electrode, and a third electrode adapted to measure a first electrical signal, a second electrical signal, and a third electrical signal of an individual, respectively. The apparatus further includes 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, using a machine learning model trained using measured twelve-lead ECG data, Leads aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 based on Lead I, Lead II, and Lead III; and providing Leads, namely Lead I, Lead II, Lead III, aVR, aVL, aVF, V1, V2, V3, V4,V5, and V6 for display on a client device.

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.

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