A device that generates an electrocardiogram

Abstract

A removable wrist-worn device that can be used as a chest cardiac device may include two chest electrodes on the inside surface of the strap (or strap portion) and two or more finger electrodes on the opposite side of the device. The device may be removed from the wrist and placed on the patient's chest with the two electrodes spaced at least 5 cm apart, in contact with the chest, and held in place by two or more fingers to capture orthogonal cardiac signals that can be combined into a conventional 12-lead cardiac signal.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This patent application claims priority as a continuation of U.S. patent application Ser. No. 17 / 726,497, filed April 21, 2022, now U.S. Patent No. 11,529,085, issued December 20, 2022, entitled "APPARATUS FOR GENERATING AN ELECTROCARDIOGRAM," which claims priority to U.S. patent application Ser. No. 18 / 068,481, filed December 19, 2022, entitled "APPARATUS FOR GENERATING AN ELECTROCARDIOGRAM," each of which is incorporated herein by reference in its entirety.

[0002] Literature citations All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. [Background technology]

[0003] Handheld electrocardiogram (ECG) devices can be used by patients (or medical personnel) to capture and record ECG data. Unfortunately, despite the potential benefits of such handheld devices, they have not seen widespread use, in part due to their size, weight, and ease of use, as well as the requirement to carry and apply the device throughout the day, which can be inconvenient and very tedious. Continuously wearable devices capable of tracking ECG have also been proposed, but these devices may be uncomfortable to use and / or may be less accurate, especially for devices that measure in areas other than the chest.

[0004] Therefore, there is a need for a compact ECG device that can capture cardiac signals from the chest, which is easy to use, convenient, and highly accurate. Summary of the Invention [Problem to be solved by the invention]

[0005] The present invention has been made to solve the problems in the conventional techniques described above. [Means for solving the problem]

[0006] The methods and apparatus (eg, systems, devices, etc.) described herein may relate generally to electrocardiography.

[0007] Generally described herein is a method and apparatus for recording and analyzing cardiac signals from a patient using a wrist-worn ECG "wristwatch" device (or, more generally, a wrist-worn device) that can be removed from the wrist and held by the subject against the subject's chest. Once removed from the subject's wrist, the device may assume a form that can be easily and accurately positioned and held by the subject against the chest to output three orthogonal leads that may be used to generate a composite 12-lead ECG signal that is compatible with a conventional 12-lead ECG signal and may be easily read by personnel skilled in standard electrocardiograms. The device is so configured.

[0008] These devices may typically include a strap (in some instances having multiple strap portions) and a housing (containing a display). The device may be a wrist-worn device that can display time and / or other information (e.g., heart rate / pulse, blood oxygenation, steps / movement, etc.) when not being used to record an ECG signal on the subject's chest. In some instances, the device may be configured as a smart watch (e.g., phone, etc.) or any other wrist-worn device. The device may include a first form configured as a wrist-worn strap that may be secured to the subject's wrist. At least two electrodes may be on an inner surface (of the strap and / or housing) and at least two electrodes may be located on an outer surface (e.g., on the strap and / or housing). The inner electrodes are configured such that when the device is removed from the wrist and transitions to a straight configuration, the inner electrodes may be separated from each other by a predetermined distance, e.g., greater than 5 cm (e.g., greater than 6 cm, greater than 7 cm, greater than 8 cm, greater than 9 cm, greater than 10 cm, greater than 11 cm, etc.), e.g., 6-14 cm (e.g., 6-13 cm, 6-12 cm, 6-11 cm, 8-10 cm, etc.). The inner (chest) electrodes may output cardiac lead signals in combination with the outer (hand / finger) electrodes to output a set of orthogonal 3-lead cardiac signals.

[0009] As used herein, cardiac signals may refer to voltages generated by a human heart sensed between selected points on the surface of a subject's body, and may also be referred to as cardiac electrical signals (e.g., electrical cardiac signals). These cardiac signals may include electrocardiogram (ECG) signals. It will be appreciated that while the term ECG is commonly used to refer to a conventional 12-lead ECG signal, the cardiac signals (cardiac electrical signals) described herein are not limited to such a conventional 12-lead ECG signal.

[0010] Described herein is a mobile, handheld device for capturing cardiac signals. The device may include a first electrode on an inner surface of a first wristband portion and a second electrode on an inner surface of a second wristband portion (or housing in some examples). The second wristband portion may be on a separate wristband or may be a second portion of the same wristband as the first wristband portion. The third and fourth electrodes are configured to be contacted by the fingers of a first and second hand, respectively, when the device is held by a subject against the subject's chest. In some cases, the subject (which may be a patient or a user) may remove the device from the wrist and hold the unclamped / unclasped device in a straight configuration against the subject's chest.

[0011] In some examples, the device is configured such that a first wristband portion that is part of a first wristband is removably coupled to a second wristband portion that is part of a second wristband. The device may also include a housing coupled to the first wristband and the second wristband, the first wristband, the second wristband, and the housing configured to form a continuous loop worn on a wrist. The housing may include electrical circuitry configured to receive electrical signals from the first, second, third, and fourth electrodes and determine a set of three-lead cardiac signals from the electrical signals, the set of three-lead cardiac signals including sufficient information to synthesize (e.g., determine, derive) conventional 12-lead electrocardiogram (ECG) information. The housing may also include a processor and / or other circuitry as described herein for recording and / or analyzing the ECG signals. The housing may also include circuitry for a clock / watch that can be displayed on a display. The same processor and circuitry may be used and / or may be integrated with circuitry for measuring, analyzing, storing, and transmitting ECG signals as described herein (including the three orthogonal leads).

[0012] Any of the devices may include a first electrode and a second electrode configured to contact the patient's chest. Further, in any of the devices described herein, the first electrode and the second electrode may be configured to be separated by a distance of at least 5 cm when the first electrode and the second electrode are receiving electrical signals from the patient's heart.

[0013] In any of the devices described herein, the third electrode may be configured to be placed in contact with a finger from a first hand and the fourth electrode may be configured to be placed in contact with a finger from a second hand, the second hand being different from the first hand. Additionally, in any of the devices described herein, the electrical circuitry may be further configured to record one or more sets of three-lead cardiac signals.

[0014] In the devices described herein, the device may further include electrical circuitry, optionally within the housing, configured to generate conventional 12-lead ECG information from at least one set of three-lead cardiac signals. Alternatively, in some examples, the device may be configured to generate conventional 12-lead ECG information from recorded signals (e.g., forming three orthogonal leads) using an external or remote processor. Additionally, in the devices described herein (e.g., wrist-worn devices and / or devices, systems, etc., including watches), the device may include a housing further including a display, the display configured to display instructions for the device to capture one or more sets of three-lead cardiac signals. The display may be configured to display time or other information while the device is worn around the wrist and operating as a watch. In some examples, the housing may include a display, the display configured to display instructions for the device to capture one or more sets of three-lead cardiac signals. In some examples, the housing may additionally or alternatively include a speaker, the speaker configured to output audible instructions for the device to capture one or more sets of three-lead cardiac signals.

[0015] In any of the apparatus described herein, the device may include a transmitter configured to transmit one or more sets of three-lead cardiac signals to a second device. Additionally, the first wristband may include conductors that electrically couple the first electrode and the second electrode to an electrical circuit, and the second wristband may include conductors that electrically couple the third electrode and the fourth electrode to an electrical circuit.

[0016] In some examples, a wearable cardiac diagnostic device is described. The wearable cardiac diagnostic device may include a first wristband portion including a first electrode, a second wristband portion including a second electrode, and third and fourth electrodes on an outer surface of the device, the device configured to removably couple the first and second wristband portions to form a continuous band worn on a subject's wrist. The device may include a housing coupleable with the first and second wristband portions, and may include a display and (in some examples) an electrical circuit configured to operate in a first mode to display time information on the display and in a second mode to receive electrical signals from the first, second, third, and fourth electrodes and determine a set of three-lead cardiac signals from the electrical signals.

[0017] In any of the wearable devices described herein, the set of three-lead cardiac signals may include sufficient information to synthesize conventional twelve-lead electrocardiogram (ECG) information. In some examples, the first electrode and the second electrode may be configured to be separated by at least 5 cm and to contact the patient's chest simultaneously. In some examples, the third electrode may be configured to receive a first cardiac signal from a finger of a first hand, and the fourth electrode may be configured to receive a second cardiac signal from a finger of a second hand different from the first hand.

[0018] In any of the wearable devices described herein, the housing may further enclose a wireless transmitter configured to transmit the three-lead cardiac data when the wearable cardiac diagnostic device is operating in the second mode. In some examples, the device may be configured to display instructions to capture one or more sets of three-lead cardiac signals when the wearable cardiac diagnostic device is operating in the second mode.

[0019] In any of the apparatus described herein, the apparatus may be configured to display information regarding electrode placement when the wearable device is operating in the second mode. The housing may further enclose a speaker configured to provide audible indication of capturing one or more sets of three-lead cardiac signals when the wearable cardiac diagnostic device is operating in the second mode.

[0020] This patent application may be related to U.S. patent application Ser. No. 17 / 092,152, filed on November 6, 2020, entitled "MOBILE THREE-LEAD CARDIAC MONITORING DEVICE AND METHOD FOR AUTOMATED DIAGNOSTICS," and U.S. patent application Ser. No. 17 / 443,456, filed on July 26, 2021, entitled "ELECTROCARDIOGRAM PATCH DEVICES AND METHODS," and U.S. patent application Ser. No. 17 / 570,368, filed on January 6, 2022, entitled "ELECTROCARDIOGRAM PATCH DEVICES AND METHODS," each of which is incorporated by reference in its entirety herein.

[0021] For example, the present specification describes a wrist-worn device configured to measure a 12-lead ECG signal, the device including a first wristband portion including a first electrode on an inside of the first wristband portion and a third electrode on an opposite side of the first wristband portion, and a second wristband portion including a second electrode on an inside of the second wristband portion and a fourth electrode on an opposite side of the second wristband portion, the first wristband portion and the second wristband portion configured to form a continuous loop worn on a subject's wrist, and further configured such that the first electrode and the second electrode are at least 6-14 cm apart to measure bioelectrical signals from the subject's chest. a second wristband portion configured to be spread apart and positioned on the subject's chest as shown in FIG. 1, wherein the third electrode is configured to measure bioelectrical signals from the subject's right hand and the fourth electrode is configured to measure bioelectrical signals from the subject's left hand; a resistive network spanning between the third and fourth electrodes and forming a center point in a sagittal plane through the subject's chest when the first and second wristband portions are held against the subject's chest, wherein three orthogonal cardiac leads are formed from the first, second, third, and fourth electrodes and the center point; and a processor configured to process the three orthogonal cardiac leads obtained from the first, second, third, and fourth electrodes.

[0022] The third electrode may be configured to be placed in contact with a finger from a first hand of the subject, and the fourth electrode may be configured to be placed in contact with a finger from a second hand of the subject, the second hand of the subject being different from the first hand of the subject.

[0023] The processor may be configured to record and transmit three orthogonal cardiac leads. The processor may be configured to synthesize conventional 12-lead electrocardiogram (ECG) information from the three orthogonal leads. The processor may be contained in a housing located between the first wristband portion and the second wristband portion.

[0024] As previously mentioned, any of these devices may include a housing enclosing the resistive network and the processor, the housing being located between the first and second wristband portions.

[0025] Any of these devices may include a display configured to show a time output when the first and second wristband portions form a continuous loop worn on the subject's wrist. The display may be configured to show an orientation of the device when the device is held against the subject's chest. Any of these devices may include a clasp configured to secure the first wristband portion to the second wristband portion around the subject's wrist.

[0026] The device may include a wireless transmitter configured to transmit data from the three orthogonal cardiac leads.

[0027] The processor may be configured to output instructions to capture one or more sets of three-lead cardiac signals when the first wristband portion and the second wristband portion are spread apart.

[0028] For example, a wrist-worn device configured to measure a 12-lead ECG signal may include a first wristband portion including a first electrode on an inside of the first wristband portion and a third electrode on an opposite side of the first wristband portion, and a second wristband portion including a second electrode on an inside of the second wristband portion and a fourth electrode on an opposite side of the second wristband portion, the first wristband portion and the second wristband portion configured to form a continuous loop worn on a wrist of a subject and further configured to be spread apart and positioned on the subject's chest such that the first electrode and the second electrode are at least 6-14 cm apart to measure bioelectrical signals from the subject's chest, and the third electrode is configured to measure bioelectrical signals from the subject's right hand. the fourth electrode configured to measure bioelectrical signals from the subject's left hand; a housing coupled between the first and second wristband portions and including a display surface; a resistive network having the housing and spanning between the third and fourth electrodes and forming a center point in a sagittal plane through the subject's chest when the first and second wristband portions are held against the subject's chest, where three orthogonal cardiac leads are formed from the first, second, third, and fourth electrodes and the center point; and a processor configured to process the three orthogonal cardiac leads obtained from the first, second, third, and fourth electrodes and to synthesize conventional 12-lead electrocardiogram (ECG) information from the three orthogonal cardiac leads.

[0029] Also described herein is a method of detecting cardiac signals from a subject, the method including the steps of removing a wrist-worn device from the subject's wrist; and placing a first wristband portion of the wrist-worn device against the subject's chest such that a first electrode on an inner surface of the first wristband portion is in contact with the subject's chest and a second electrode on an inner surface of the second wristband portion is in contact with the subject's chest, the first electrode being spaced about 6-12 cm from the second electrode; and placing fingers of a first hand against a third electrode on an outer surface of the wrist-worn device and fingers of a second hand against the wrist. the step of placing the wristband portion against a fourth electrode of the wearable device; measuring three orthogonal leads using a resistive network that spans between the third and fourth electrodes and forms a center point in a sagittal plane through the subject's chest when the first and second wristband portions are held against the subject's chest, wherein the three orthogonal cardiac leads are formed from the first, second, third, and fourth electrodes and the center point; processing the three orthogonal cardiac leads to synthesize conventional 12-lead electrocardiogram (ECG) information; and outputting the conventional 12-lead ECG information.

[0030] Any of these methods may include removing the wrist-worn device from the subject's wrist by uncoupling a latch on the wrist-worn device Any of these methods may include transmitting the three orthogonal cardiac leads from the wrist-worn device to a remote processor for processing the three orthogonal cardiac leads.

[0031] The step of placing the fingers of the first hand against the third electrode may include placing the fingers of the first hand against the third electrode on an outer surface of the first wristband portion, and the step of placing the fingers of the second hand against the fourth electrode includes placing the fingers of the second hand against the fourth electrode on an outer surface of the second wristband portion. In some examples, the step of placing the fingers of the first hand against the third electrode includes placing the fingers of the first hand against a housing including a display, the housing being between the first wristband portion and the second wristband portion.

[0032] Processing the three orthogonal leads may include processing using a processor contained in a housing located between the first wristband portion and the second wristband portion. Any of these methods may include displaying the time output on a display of the wrist-worn device when the wrist-worn device is worn on the subject's wrist.

[0033] The methods described herein may include the step of instructing a subject via output from the wrist-worn device how to hold the wrist-worn device against the subject's chest.

[0034] Any of the methods and devices described herein may be configured to monitor a patient's cardiac activity while the device is worn on the wrist, and may alert the wearer (or a caregiver) to take a chest recording with the device if the device detects activity above a monitoring threshold. For example, any of the devices may include one or more sensors (e.g., electrodes, optical sensors (e.g., photoplethysmography (PPG) sensors), etc.) and may include software, hardware, or firmware (e.g., as part of a controller) to monitor the sensor output periodically (e.g., about every x minutes (where x is 0.1, 0.2, 0.25, 0.3, 0.5, 1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, etc.)) or continuously to determine whether a detected signal falls within the range of a cardiac problem or has a pattern characteristic of a cardiac problem. The device may provide an alert on the wrist-worn device, which may be done by one or more of displaying a message (text, graphic, etc.), flashing a light, making a sound, etc. In some examples, the device may send a message (e.g., SMS message / text message, email, etc.) to the wearer and / or caregiver. In some examples, the message may include advice or instructions such as "Chest recording recommended." Thus, any of these devices may include a monitoring mode when worn on the wrist. The device may be configured to enter the monitoring mode manually or automatically, such as when it detects that the device is worn on the wrist by the user.

[0035] All of the methods and apparatus described herein, in any combination, are contemplated herein and may be used to achieve the benefits described herein.

[0036] A better understanding of the features and advantages of the methods and apparatus described herein will be obtained by reference to the following detailed description, which sets forth illustrative and illustrative examples, and the accompanying drawings, in which: [Brief description of the drawings]

[0037] [Figure 1A] 1 illustrates an example of a system for detecting and / or diagnosing a cardiac signal. [Figure 1B] 1 shows a diagram of another example of a system for cardiac signal detection. [Figure 2A] ~ [Figure 2C] 1A-1C show front, rear and axonometric views, respectively, of an example handheld device. [Figure 2D] FIG. 1 shows a front view of the device placed against a patient's body in a recording position. [Figure 3A] An example of a simple electrical scheme to acquire a central point (CP) signal is shown by connecting electrodes on both hands through a simple resistive network consisting of two resistors. [Figure 3B] An electrical scheme for obtaining the CP signal by buffering and averaging with an operational amplifier is shown. [Figure 4A] 1 shows a front view of an example of a wrist-worn device as described herein. [Figure 4B] FIG. 4B shows a rear view of the wrist-worn device of FIG. 4A. [Figure 5A] FIG. 2 shows a left side view of an example of a wrist-worn device. [Figure 5B] FIG. 5B shows a right side view of the wrist-worn device of FIG. [Figure 6] 1 shows a schematic diagram depicting the placement of a wrist-worn device. [Figure 7] 1 shows a flowchart of an exemplary operation for receiving and capturing cardiac signals by a wrist-worn device described herein. [Figure 8] FIG. 1 illustrates a block diagram of a wrist-worn device that may be included in any suitable wrist-worn device described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0038] Described herein are apparatus (including devices and systems) and methods for collecting, observing, and / or monitoring cardiac information. For example, the apparatus described herein is configured to be worn on a subject's wrist as a watch, smart watch, etc. in a first configuration and converted to a second configuration in which the apparatus is held by the subject against the subject's chest to acquire and record three cardiac lead signals. These cardiac lead signals may be orthogonal and contain sufficient information to synthesize, derive, or determine conventional 12-lead cardiac data. These handheld devices may also perform one or more auxiliary functions (e.g., timekeeping or monitoring functions). The implementation of auxiliary functions allows patients to easily wear or carry cardiac monitoring devices, thereby enabling cardiac monitoring in a variety of locations, many outside of clinical settings.

[0039] In some examples, cardiac data associated with the three cardiac lead signals may be transmitted to a separate device for monitoring or analysis. For example, the three lead signal data may be transmitted to a remote unit (server, processor, computer, tablet computer, etc.) for processing, combination (to conventional 12 lead data), and / or display to a clinician. In another example, a handheld device may include a processor capable of performing the processing and combination, and may include a display to provide information to a user.

[0040] FIG. 1A illustrates an example of a system 100 for cardiac signal detection and / or diagnosis. The wrist-worn devices described herein may perform any or all of the functions shown and described with respect to FIGS. 1A-1B, 2A-2D, and 3A-3B, but may be configured as described herein. The system 100 may include a device 2, which includes one or more electrodes mounted, disposed, or coupled to the device 2 (e.g., a housing 3). In FIG. 1A, a user (e.g., a subject, patient, or clinician) may acquire and / or record cardiac signals (possibly acquiring and recording at two or more different time points), and the handheld device 2 may process three orthogonal cardiac leads to compare the different time points (e.g., comparing a baseline to an assay time point). A processor (not shown) of the handheld device 2 may further determine whether the resulting differential cardiac lead signals (the difference over two or more time points at which the cardiac signals were recorded or "acquired") indicate a possible cardiac problem and may alert the user. FIG. 1B shows a diagram of another example of a system 100 that includes a handheld device 2 incorporating built-in electrodes for acquiring cardiac signals mounted directly on a housing 3 of the handheld device 2, and a remote processor (e.g., a personal computer (PC)) 4 connected to the handheld device 2 by an electrical communication link.

[0041] Device 2 may further incorporate cardiac signal recording circuitry, including one or more amplifiers for amplifying cardiac signals detected by the electrodes, and an analog-to-digital converter (ADC), as well as data storage (e.g., memory) for storing cardiac signal data. Device 2 may also include communications circuitry operating on GSM, WWAN, Wi-Fi, or any other feasible telecommunications standard for communication with remote processor 4. In this manner, device 2 may transmit recorded or acquired cardiac signals or cardiac lead information to one or more remote devices, such as remote processor 4. Device 2 may include video and / or audio circuitry or devices (e.g., a display, monitor, speaker, etc.) for communicating diagnostic information to a user.

[0042] The device 2 may communicate with the remote processor 4 via an integrated communication circuit. The remote processor 4 may in turn communicate with the handheld device 2 via an integrated communication module. The remote processor 4 may be equipped with diagnostic software for processing the received cardiac signals, generating diagnostic information, and transmitting the diagnostic information back to the device 2 and communicating the diagnostic information to the user, either by a speaker generating a characteristic sound or audio message, or in the form of graphical information by a video and / or audio circuit or device integrated in the device 2. As a result, the system 100 may be able to perform automatic detection of cardiac conditions based on the three-lead system, without the need for expert interpretation of the diagnostic information. Alternatively, the device 2 may incorporate a microprocessor in the housing 3, which replaces the remote processor 4, for processing acquired or recorded cardiac lead signals to generate diagnostic information.

[0043] 2A, 2B, and 2C show front, rear, and axonometric views, respectively, of an example of device 200. Device 200 may be an example of device 2 of FIGS. 1A and 1B. FIG. 2A shows a front view of device 200 in a recording position held by a patient. Device 200 may include a housing 3 and electrodes C, D, and G disposed on the front surface 6. FIG. 2B shows a rear view of device 200. As shown, electrodes A and B may be disposed on the rear surface 5 of housing 3. FIG. 2C shows an axonometric view of device 200. This view shows electrodes C, D, and G disposed on the front surface 6 of housing 3 and electrodes A and B disposed on the rear surface 5 of housing 3. In some examples, electrode G may be referred to as a ground electrode. Device 200 may also include an additional electrode in contact with the patient, hidden in this view.

[0044] The housing 3 of the handheld device 200 may incorporate electrodes A, B, C, D, and G arranged in an array that allows recording of three electrocardiogram (ECG) lead signals. For example, electrodes A and B mounted on the back surface 5 of the device 200 may contact the patient's chest when the device 200 is in a recording position. Electrodes A and B (which may be referred to as chest electrodes) are preferably arranged to cover a distance (e.g., a distance separated by) at least more than 5 cm, preferably more than about 10 cm. One reason for having such a spatial arrangement is to achieve a distance greater than the approximate diameter of the myocardium that would be required to achieve and / or improve possible lead orthogonality.

[0045] In addition to the two chest electrodes A and B, the handheld device in this example may include two other electrodes C and D, mounted generally parallel on the front surface 6 opposite the back surface 5. These electrodes C and D may be used to capture or record cardiac signals from the patient's hands by pressing with the fingers of the left and right hands, respectively. A fifth electrode G may act as a ground electrode and is mounted on the front surface 6 for pressing with the fingers of the left hand.

[0046] Referring again to FIG. 2A, a diagram of one example of the device in a recording position is shown. To operate, the patient may place their left hand with their index and middle fingers in contact with electrodes C and G, respectively. The patient may then position and press the handheld device 200 against their chest, with chest electrodes A and B in contact with the chest and in intimate contact with the device, as shown in FIG. 2D. This provides sufficient pressure to hold the device against the chest. At the same time, the fingers of the right hand (or any other part of the right hand) may press against electrode D, which is mounted on the front surface 6 of the housing 3.

[0047] 2D, there is shown a front view of device 200 applied to a patient's body in a recording position according to one example of the present invention. In an optimal recording position, the center of device 200 may be positioned near the top of the center of the heart, with chest electrodes A and B approximately above the midclavicular line (a vertical line passing through the midpoint of the clavicle), and lower chest electrode B approximately at the same level as the lower end of the sternum.

[0048] The example of FIG. 3A shows a simple electrical scheme for obtaining a central point (CP) signal by connecting electrodes on both hands through a simple resistive network of two resistors. Similarly, FIG. 3B shows an electrical scheme for obtaining a CP signal by buffering and averaging with an operational amplifier. The CP signal may be used to provide an optional reference (e.g., a reference voltage) that may be used in combination with signals from electrodes A, B, C, D, E, and G to generate three orthogonal cardiac lead signals. In some examples, the three orthogonal cardiac lead signals may be used to generate a conventional 12-lead ECG signal. One method for converting the three orthogonal cardiac signals is described at least in U.S. Patent Application Serial No. 17 / 494,806, which is incorporated herein by reference.

[0049] As described herein, the apparatus (e.g., device, system, etc.) 200 may be implemented as a wristwatch. The wristwatch may then be worn by a subject and used whenever convenient to capture, record, and / or transmit cardiac signals or cardiac data. In this manner, the wristwatch 200 may be a wearable cardiac diagnostic device. One such implementation is described with reference to FIGS. 4-6.

[0050] In general, the use of resistive circuitry is optional. Any of the devices described herein may be used without resistive circuitry or may not include resistive circuitry as described. For example, the devices may be configured to record two (or more) channels and store and / or transmit the recorded channels for direct analysis by a physician and / or software or for further processing.

[0051] FIG. 4A shows a front view of a wrist-worn device 400. As shown in FIG. 4A, the wrist-worn device 400 may be implemented as a wrist watch. The wrist-worn device 400 may include a first wristband portion 410, a housing 420, and a second wristband portion 430. The first wristband portion 410 may be removably coupled to the second wristband portion 430 with a clasp, latch, or the like, allowing the patient to wear the wrist-worn device 400 on the wrist. The wrist-worn device may be configured to be slightly biased in the wrist-worn configuration (as shown in FIGS. 5A-5B) or may be relatively flat in a straight (unlatched) configuration. The biased, slightly concave configuration shown in FIGS. 5A-5B may help the device to remain against the patient's chest.

[0052] The housing 420 may include a display 421 that may be used to provide information to the patient. For example, the display 421 may provide information associated with a traditional wristwatch (e.g., time, date, and other clock information) when operating in a first mode. In some examples, the device may be configured to provide instructions related to recording ECG signals using the wrist-worn device. For example, the wrist-worn device may be configured to record ECG signals when operating in a second mode, and the display 421 may provide information related to the ECG information, including instructions on how to position and use the device when recording ECG information. For example, the display 421 may display an image related to the placement of the wrist-worn device 400 on the patient's body. In another example, the display 421 may display instructions and / or information related to the acquisition and analysis of the patient's cardiac lead signals. In some examples, the housing 420 may enclose a speaker (not shown) that may provide audio information to the patient. For example, the speaker may provide audible instructions regarding the use or placement of the wrist-worn device 400. In another example, a speaker may emit a sound associated with the acquisition of a cardiac lead signal.

[0053] In some examples, the housing 420 may enclose a transceiver 422 that may be configured to communicate with any other suitable device. For example, the housing 420 may enclose a Bluetooth transceiver that may be used to communicate cardiac signal data to any suitable Bluetooth enabled device (e.g., a smartphone, etc.). In another example, the housing 420 may enclose a Wi-Fi transceiver that may be used to communicate cardiac signal data to any suitable Wi-Fi enabled device (including a computer (laptop computer, desktop computer, tablet computer, etc.), a Wi-Fi access point, a smartphone, etc.). In yet another example, the housing 420 may enclose a cellular transceiver that may be used to communicate cardiac signal information over any suitable cellular network.

[0054] In some examples, cardiac data (e.g., acquired cardiac lead signals) may be analyzed in a remote processor (e.g., remote processor 4 of FIG. 1B). For example, cardiac data may be transmitted directly or indirectly to remote processor 4 using a transceiver 422 built into the housing 420. In other examples, the housing 420 may enclose a processor 423. The processor 423 may analyze any acquired and / or recorded cardiac lead signals. For example, any operation that may be performed by remote processor 4 may be performed by processor 423. In any of the devices described herein, the circuitry and / or processor may be embedded in the strap rather than or in addition to the housing.

[0055] The first wristband portion 410 may include a first electrode 411 and a second electrode (shown in FIG. 4B) disposed on an inner surface of the first wristband portion 410 and the second wristband portion 430. The inner surface may refer to a surface configured to be worn against the wrist in the first wrist-worn configuration, and the surface may be configured to be held against the chest in the ECG acquisition configuration. The second electrode may be on the second wristband portion 430 or on the housing 420 (not shown). The third electrode 431 and the fourth electrode 432 may be disposed on opposite sides of the device (e.g., on opposite (outward facing) sides of the first wristband portion 410 and the second wristband portion 420 and / or may be disposed on the housing. In some examples, a portion of the patient's body may contact the first electrode 411 and the second electrode 431 for the processor 423 to identify three orthogonal cardiac lead signals. For example, a right finger may be placed in contact with the third electrode 412 and a left finger may be placed in contact with the fourth electrode 432.

[0056] FIG. 4B shows a rear view of the wrist-worn device 400. As mentioned above, the third electrode 412 may be disposed on the first wristband portion 410 opposite the first electrode 411. Similarly, the fourth electrode 432 may be disposed on the second wristband portion 430 opposite the third electrode 431. In some uses, the wrist-worn device 400 may be placed against the patient's chest, such that the second electrode 412 and the fourth electrode 432 are placed in contact with the chest. In some examples, the first electrode 411 may be separated from the second electrode 431 by a distance of at least 5 cm. In some cases, this separation distance may be at least 10 cm, such that the second electrode 412 and the fourth electrode 432 may span a distance longer than a typical heart muscle. Thus, the first electrode 411 and the second electrode 431 are capable of receiving electrical signals from the patient's heart.

[0057] The patient may be guided by the wrist-worn device 400 to properly place the wrist-worn device 400 in an optimal position on the chest so that the first electrode 411 and the second electrode 431 can capture and / or detect cardiac signals from the patient's heart. For example, the wrist-worn device 400 may display one or more images on the display 421 and / or provide audible instructions through the speaker 425 to guide placement of the wrist-worn device 400 on the patient. In some examples, the rear of the housing 420 may act as an additional or alternative electrode. For example, the rear of the housing 420 may perform the function associated with a ground electrode.

[0058] The housing 420 may enclose circuitry 424 for acquiring and / or recording cardiac lead signals from one or more of the first electrode 411, the second electrode 431, the third electrode 412, and the fourth electrode 432. In some examples, the circuitry 424 may acquire and / or record cardiac lead signals from a ground electrode (e.g., the back of the housing 420, or any of the described electrodes performing the function of a ground electrode). Thus, the first electrode 411, the second electrode 431, the third electrode 412, and the fourth electrode 43 (as well as the housing 420, in some cases) may be coupled to the circuitry 424 for acquiring and / or recording cardiac lead signals. In some examples, the circuitry 424 may include any number of suitable filters, amplifiers, analog-to-digital converters, memory, etc. for acquiring and / or recording cardiac signals.

[0059] In some examples, the processor 423, in combination with the circuitry 424, may receive data from one or more coupled electrodes to identify one or more sets of orthogonal three-lead cardiac signals. In some examples, the processor 423 may record sensor data from one or more electrodes, three-lead cardiac data, or synthesized (e.g., derived) twelve-lead cardiac data (e.g., twelve-lead electrocardiogram (ECG) information). The processor 423, in combination with the transceiver 422, may transmit cardiac data (including the orthogonal three-lead cardiac signal data) to another device for further processing or analysis. In some examples, the processor 423 or a separate device may process acquired or recorded cardiac data to synthesize conventional twelve-lead cardiac data. That is, the three-lead cardiac signal data may include all information sufficient to synthesize conventional twelve-lead cardiac data.

[0060] In some examples, the processor 423 can process cardiac signal data collected through the electrodes and circuitry 424 to determine if the wrist-worn device 400 is placed incorrectly. The processor 423 can also instruct the user to properly place the wrist-worn device 400 and / or to properly place their fingers over any appropriate electrodes. For example, the processor 423 can provide instructions to the user through the speaker 425 and / or a display.

[0061] 5A shows a left side view of a wrist-worn device 500. The wrist-worn device 500 may include a first wristband portion 510, a housing 520, and a second wristband portion 530. The wrist-worn device 500 may be an example of the wrist-worn device 400 of FIGS. 4A and 4B. Thus, the first wristband portion 510 may be an example of the first wristband 410, the housing 520 may be an example of the housing 420, and the second wristband portion 530 may be an example of the second wristband 430.

[0062] As shown, the first wristband portion 510 may include a first electrode 511 and a third electrode 512. The second wristband portion 530 may include a second electrode 531 and a fourth electrode 532. Figure 5B shows a right side view of the wrist-worn device 500. The wrist-worn device 500 includes a first wristband portion 510, a housing 520, and a second wristband portion 530. In some examples, the back of the housing 520 may act as a fifth electrode.

[0063] The first electrode 511, the second electrode 531, the third electrode 512, and the fourth electrode 532 may be electrically coupled to a circuit or the like within the housing 520 by one or more conductors (wires, etc.) surrounded (or embedded) in the first wristband 510 and the second wristband 530.

[0064] In some examples, the wrist-worn device 500 may operate in a first mode as a watch or any other similar or suitable timekeeping device (e.g., a watch). In some cases, the first wristband portion 510 may be removably coupled to the second wristband portion 530 to form a continuous loop with the housing 520. When so coupled, the wrist-worn device 500 may be easily and comfortably worn on the wrist of a user or patient. Although the strap ("wristband") shown in FIGS. 4A-4B and 5A-5B includes two portions, each connected to a housing, in some examples, a single strap or band may be included and coupled to the housing, or the housing may be integral with the strap or band. In examples having a single strap or band, the device may have both the first and second portions on the same band or strap.

[0065] In a second mode, the wrist-worn device 500 may operate to capture one or more cardiac signals through one or more electrodes. In the second mode, the wrist bands may be decoupled from each other and the wrist-worn device may be placed on the patient's chest. Thus, the second electrode 531 and the first electrode 511 (and optionally the housing 520) may be placed in contact with the patient's chest. In some examples, the second electrode 531 may be separated from the first electrode 511 by a distance of at least 5 cm, and in some cases by a distance of at least 10 cm (e.g., 5-14 cm, 6-12 cm, 8-12 cm, etc.) (particularly when the wrist-worn device 500 is placed on the patient's chest).

[0066] In a second mode, a processor (embedded in the housing 520) may capture, record, and possibly analyze cardiac signals. For example, the processor may synthesize conventional 12-lead ECG information from cardiac signals received by one or more electrodes of the wrist-worn device 500. Alternatively or additionally, the wrist-worn device 500 may transmit data associated with the captured cardiac signals to another device to enable remote monitoring and / or analysis of the patient's cardiac health. In some examples, the device receiving the data may synthesize conventional 12-lead ECG information.

[0067] FIG. 5B shows a right side view of the wrist-worn device 500. The wrist-worn device 500 includes a first wristband portion 510, a housing 520, and a second wristband portion 530. The first wristband portion 510 includes a first electrode 511 and a second electrode 512. In this example, the second wristband portion 530 includes a second electrode 531 and a fourth electrode 532. Although FIGS. 4A-4B and 5A-5B show multiple adjacent electrodes on the inner surface 529 and the outer surface 540, in some examples, only one electrode each is used. Alternatively or additionally, multiple electrodes may be used and the entire system may be filtered.

[0068] Figure 6 shows a schematic diagram 600 depicting the placement of the wrist-worn device 610 shown in Figures 4A-4B and 5A-5B. The wrist-worn device 610 may be placed (on) the left chest of a patient 620 such that the electrodes in contact with the chest approximately straddle the patient's heart. Fingers from the patient's hand may be placed in contact with the electrodes. For example, a finger from the patient's left hand 630 may be placed in contact with one electrode on a wrist band and another finger from the patient's right hand 640 may be placed in contact with another electrode on another wrist band.

[0069] In some examples, the wrist-worn device 610 may guide the patient 620 to optimize the placement of the wrist-worn device on the patient 620. For example, a processor within the wrist-worn device 610 may receive one or more cardiac signals, particularly from electrodes in contact with the patient's chest. The wrist-worn device 610 may analyze these signals and determine if the placement of the wrist-worn device 610 is incorrect. If so, the wrist-worn device 610 may display placement instructions or, in some cases, issue audible instructions to guide the patient to correct the placement of the wrist-worn device 610.

[0070] The device configurations shown in Figures 4A-4B, 5A-5B, and 6 are merely examples of wrist-worn devices. In some examples, the wrist-worn device does not include a watch body having a watch face, but is a simple continuous strap. The strap may include a first portion and a second portion as described herein. In some examples, a body may be included, but may not be configured as a watch body.

[0071] FIG. 7 illustrates a flow chart 700 of an exemplary operation for receiving and capturing a cardiac signal by a wrist-worn device. The wrist-worn device may be the wrist-worn device 400 of FIGS. 4A and 4B, the wrist-worn device 500 of FIGS. 5A and 5B, the wrist-worn device 610 of FIG. 6, or any other suitable wrist-worn device. The operation of FIG. 7 begins with the wrist-worn device detecting a cardiac signal in block 702. For example, the wrist-worn device may detect a cardiac signal for a set of three-lead cardiac signals through built-in electrodes. The cardiac signal may be detected through one or more electrodes. If a cardiac signal is not detected, the operation may continue to periodically (or continuously) check whether a cardiac signal is detected. On the other hand, if a cardiac signal is detected, the wrist-worn device may read and / or process an ECG (cardiac) signal in block 704. In some examples, once a cardiac signal is detected, the wrist-worn device may transition from a first mode (e.g., a timekeeping mode operating as a watch) to a second mode capturing a cardiac signal. Alternatively or additionally, the user may select a control or input to indicate that the mode is switching from timekeeping, etc., to detecting an ECG signal. The wrist-worn device may conserve power by operating in a low power monitoring mode rather than a relatively high power mode in which it captures and / or processes a cardiac signal by waiting until a cardiac signal is detected.

[0072] At block 704, the wrist-worn device may capture an ECG (cardiac) signal. For example, the wrist-worn device may capture the cardiac signal through one or more built-in electrodes. The wrist-worn device may then perform signal processing on the captured cardiac signal at block 706. For example, the cardiac signal may be buffered, amplified, digitized (e.g., by one or more analog-to-digital converters), etc. The processed cardiac signal may be stored in memory at block 708.

[0073] Next, in block 710, 12-lead ECG information may be synthesized from the processed cardiac signal data. This operation may be optional, as indicated by the dashed lines in FIG. 7. Thus, the wrist-worn device may include a processor capable of synthesizing (deriving, determining) 12-lead ECG information from the processed cardiac signal data (including processed cardiac signal data that may include 3-lead cardiac signal data). In block 712, the wrist-worn device may display the 12-lead ECG information data on a display. In some examples, the display may be separate from the wrist-worn device.

[0074] Returning to block 708, the wrist-worn device may wirelessly transmit the processed cardiac signal data in block 714. For example, the wrist-worn device may transmit the captured 3-lead cardiac signal data directly or indirectly to one or more remote devices. In block 716, the remote device may synthesize 12-lead ECG information. The 12-lead ECG information may be analyzed or monitored by a clinician to ascertain the patient's cardiac health.

[0075] 8 shows a block diagram of an exemplary wrist-worn device 800. The wrist-worn device 800 may include electrodes 810, processing circuitry 815, a wireless transceiver 820, a processor 330, memory 840, an input / output device 850, and a time management circuit 860.

[0076] The electrodes 810 may be built into the wrist-worn device 800 or may be external to the wrist-worn device 800, for example, disposed on one or more wrist bands (not shown). The electrodes 810 may be coupled to a processing circuit 815. The processing circuit may include buffers, amplifiers, analog-to-digital converters, etc., to capture and / or digitize the cardiac signals received by the electrodes 810. The processing circuit 815 may be coupled to a processor 830.

[0077] The wireless transceiver 820 may include circuitry and / or devices for wireless communication with any other suitable devices and is coupled to the processor 830. In some examples, the wireless transceiver 820 may include Bluetooth, Wi-Fi, cellular, or any other suitable wireless communication circuitry. In some examples, the processor 830 may transmit the captured cardiac signal data via the wireless transceiver 820 to another device, which may synthesize conventional 12-lead ECG information data therefrom.

[0078] The input / output devices 850 are coupled to the processor 830 and may include video and / or audio devices for displaying or audibly presenting feedback or information to the patient or clinician. A timekeeping circuit 860 is also coupled to the processor 830 and may be used to provide time information that may be displayed on a display (e.g., a display integrated into the input / output devices 850).

[0079] Processor 830 is also coupled to memory 840 and may be any suitable processor or processors capable of executing scripts or instructions of one or more software programs stored within wrist-worn device 800 (e.g., in memory 840).

[0080] The memory 840 may include a data storage area 842 that may be used to locally store cardiac signal data collected from the electrodes 810. For example, the electrodes 810 may receive cardiac signals that are processed by the processing circuitry 815 and then stored in the data storage area 842.

[0081] The memory 840 may also include a non-transitory computer readable storage medium (e.g., one or more non-volatile memory elements, e.g., EPROM, EEPROM, flash memory, hard drive, etc.) that may store the following software modules: a cardiac signal synthesis module 844 for synthesizing 12-lead ECG information. Each software module includes program instructions that, when executed by the processor 830, can cause the wrist-worn device 800 to perform a corresponding function. Thus, the non-transitory computer readable storage medium of the memory 840 may include instructions to perform all or a portion of the operations described herein.

[0082] The processor 830 may execute a cardiac signal synthesis module 844 to generate or synthesize conventional 12-lead ECG information from cardiac signal data that may be stored in the data storage area 842. For example, orthogonal three-lead cardiac signal data may be captured through the electrodes 810 and then stored in the data storage area 842. Execution of the cardiac signal synthesis module 844 may cause the processor 830 to retrieve some or all of the cardiac signal data stored in the data storage area 842 and generate 12-lead ECG information based thereon. One method for converting the three orthogonal cardiac signals into 12-lead ECG information is described at least in U.S. patent application Ser. No. 17 / 494,806, which is incorporated herein by reference.

[0083] Optionally, any of these devices may include the ability to detect cardiac events when the device is worn on the wrist, to trigger an alert to have the user or a caregiver (e.g., doctor, nurse, technician, family member, etc.) use the device to obtain a reading as described above. For example, as shown in FIG. 8, any of these devices may include wrist-worn monitoring functionality using one or more sensors. In some examples, the sensors may be electrodes 810 used for measurements from the chest, while in other device examples, a separate dedicated sensor 846 may be used. For example, one or more photoplethysmography (PPG) sensors on the device (e.g., on the strap and / or housing) may be used. The processing circuitry 815 may be configured to process signals when the device is worn on the patient's wrist, and may periodically or continuously monitor the patient based on the detected signals. In some examples, the signals may be detected from sensors on various parts of the inner surface of the strap and / or housing (e.g., watch housing), which may identify which sensor is detecting the presence of the patient and cardiac signals. For example, if PPG is used, the PPG signal may detect the heartbeat and the regularity of the heartbeat may be determined.

[0084] If either the electrical signal (e.g., electrode signal) or the PPG signal is present, a time domain analysis of the signal may be performed to extract features that may be indicative of a cardiac problem. The device may use the extracted features to determine whether the patient is in a state of cardiac distress or is likely to become in a state of cardiac distress. The determination of a diseased or healthy state may be made by the processing circuitry 815 and / or the processor 830 (e.g., based on decision trees, discriminant analysis, logistic regression, etc.).

[0085] In some examples, the device may perform continuous (or periodic) monitoring and recording as described above, may perform signal denoising, and / or may pre-process (e.g., filter) the signal or use the raw signal to determine heart rate variability (HRV), and if the HRV exceeds a threshold (which may be tailored specifically for the patient or may be generic), the device may trigger an alert.

[0086] It will be appreciated that all combinations of the above concepts, and further concepts detailed below (unless there is a contradiction between such concepts), are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.

[0087] The process parameters and sequences of steps described and / or illustrated herein are provided by way of example only and may be modified as desired. For example, although the steps illustrated and / or described herein may be illustrated or described in a particular order, the steps need not necessarily be performed in the order illustrated or described. Various exemplary methods described and / or illustrated herein may omit one or more of the steps described and / or illustrated herein or may include additional steps in addition to those disclosed.

[0088] Any of the methods described herein (including user interfaces) may be implemented as software, hardware, or firmware and may be described as a non-transitory computer-readable storage medium storing a set of instructions executable by a processor (e.g., computer, tablet, smartphone, etc.) that, when executed by the processor, cause the processor to control the execution of any of the steps including, but not limited to, displaying, communicating with a user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, etc. For example, any of the methods described herein may be performed, at least in part, by an apparatus that includes one or more processors having a memory that stores a non-transitory computer-readable storage medium that stores a set of instructions for the process of the method.

[0089] Although various embodiments have been described and / or illustrated herein in the context of a fully functional computing system, one or more of these exemplary embodiments may be distributed as a program product in various forms, regardless of the specific type of computer-readable medium used to actually effect the distribution. The embodiments disclosed herein may also be implemented using software modules that perform specific tasks. These software modules may include scripts, batch, or other executable files that may be stored on a computer-readable storage medium or on a computing system. In some embodiments, these software modules may configure a computing system to implement one or more of the exemplary embodiments disclosed herein.

[0090] As described herein, the computing devices and systems described and / or illustrated herein broadly represent any type or form of computing device or system capable of executing computer-readable instructions, such as those stored in the modules described herein. In their most basic configurations, these computing devices may each include at least one memory device and at least one physical processor.

[0091] As used herein, the term "memory" or "memory device" broadly refers to any type or form of volatile or non-volatile storage device or storage medium capable of storing data and / or computer-readable instructions. In one example, a memory device may store, load, and / or retain one or more of the modules described herein. Examples of memory devices include, but are not limited to, random access memory (RAM), read-only memory (ROM), flash memory, hard disk drive (HDD), solid-state drive (SSD), optical display drive, cache, variations or combinations of one or more of these, or any other suitable storage memory.

[0092] Furthermore, the term "processor" or "physical processor" as used herein broadly refers to any type or form of hardware-implemented processing unit capable of interpreting and / or executing computer-readable instructions. In one example, a physical processor may access and / or modify one or more modules stored in the memory device described above. Examples of physical processors include, but are not limited to, a microprocessor, a microcontroller, a central processing unit (CPU), a field programmable gate array (FPGA) implementing a soft-core processor, an application specific integrated circuit (ASIC), portions of one or more of these, variations or combinations of one or more of these, or any other suitable physical processor.

[0093] Each method step described and / or illustrated herein may represent part of a single application, even though shown as separate elements. Further, in some embodiments, one or more of these steps may represent or correspond to one or more software applications or programs that, when executed by a computing device, can cause the computing device to perform one or more tasks, such as method steps.

[0094] Further, one or more of the devices described herein may transform data, physical devices, and / or representations of physical devices from one form to another. Additionally or alternatively, one or more of the modules described herein may transform a processor, volatile memory, non-volatile memory, and / or any other portion of a physical computing device from one form of computing device to another form of computing device, which may be done by executing on the computing device, storing data on the computing device, and / or interacting with other computing devices.

[0095] As used herein, the term "computer-readable medium" broadly refers to any form of device, carrier, or medium capable of storing or carrying computer-readable instructions. Examples of computer-readable media include, but are not limited to, transmission-type media (e.g., carrier waves) and non-transitory-type media (e.g., magnetic storage media (e.g., hard disk drives, tape drives, and floppy disks), optical storage media (e.g., compact discs (CDs), digital video discs (DVDs), and BLU-RAY discs), electronic storage media (e.g., solid-state drives and flash media), and other distribution systems).

[0096] As will be appreciated by those skilled in the art, any process or method disclosed herein may be modified in various ways. The process parameters and sequences of steps described and / or illustrated herein are given by way of example only and may be modified as necessary. For example, although the steps illustrated and / or described herein may be illustrated or described in a particular order, these steps do not necessarily have to be performed in the order illustrated or described.

[0097] The various exemplary methods described and / or illustrated herein may omit one or more of the steps described and / or illustrated herein or may include additional steps in addition to those disclosed. Furthermore, one step of any method disclosed herein may be combined with any one or more steps of any other method disclosed herein.

[0098] The processors described herein may be configured to perform one or more steps of any of the methods disclosed herein. Alternatively, or in combination, the processors may be configured to combine one or more steps of one or more of the methods disclosed herein.

[0099] In this specification, when a feature or element is referred to as being "on" another feature or element, the feature or element may be directly adjacent to the other feature or element, or there may be intervening features and / or elements. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features and / or elements. It should also be understood that when a feature or element is referred to as being "connected," "attached," or "coupled" to another feature or element, the feature or element may be directly connected, attached, or coupled to the other feature or element, or there may be intervening features or elements. In contrast, when a feature or element is referred to as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements. Features and elements so described or illustrated may be described or illustrated with respect to one embodiment, but may also apply to other embodiments. Also, as will be understood by those skilled in the art, when a structure or feature is referred to as being "adjacent" to another feature, the reference may include portions that overlap or underlie the adjacent feature.

[0100] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. For example, the singular forms "a," "an," and "the" as used herein are intended to include the plural forms as well, unless the context clearly contradicts otherwise. It is further understood that the terms "comprises" and / or "comprising," as used herein, specify the presence of stated features, steps, operations, elements, and / or components, and 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 combination of one or more of the associated listed items and may be abbreviated as " / ."

[0101] Spatially relative terms such as "under," "below," "lower," "over," "upper," and the like may be used herein for ease of description when describing the relationship of one element or feature to another element or feature as depicted in the figures. It should be understood that the spatially relative terms are intended to encompass other orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures were inverted, an element described as being "under" or "beneath" another element or feature would be oriented "over" that other element or feature. Thus, for example, the term "under" can encompass both an orientation of "over" and "under." The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, terms such as "upwardly," "downwardly," "vertical," "horizontal," etc. are used herein for descriptive purposes only, unless otherwise specified.

[0102] The terms "first" and "second" may be used herein to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element may be referred to as a second feature / element below, and similarly, a second feature / element may be referred to as a first feature / element below, without departing from the teachings of the present invention.

[0103] Throughout the following claims, unless otherwise stated, the word "comprise" and its variations, such as "comprises," "comprising," etc., mean that various components may be used in conjunction with one another in methods and articles (e.g., devices and compositions and apparatuses that include methods). For example, the word "comprising" should be understood to imply the inclusion of all stated elements or steps, but not the exclusion of any other elements or steps.

[0104] In general, any apparatus and methods described herein should be understood to be inclusive, although all or some of the components and / or steps may alternatively be exclusive, and may be expressed as "consisting of" or alternatively "consisting essentially of" various components, steps, sub-components, or sub-steps.

[0105] As used in the present specification and claims, including in the examples, and unless otherwise specified, any numerical value may be read as being preceded by the term "about" or "approximately", even if the term is not explicitly present. The term "about" or "approximately", when describing a size and / or location, may be used to indicate that the stated value and / or location falls within a reasonable expected range of values ​​and / or locations. For example, a numerical value may be ±0.1% of the stated value (or range of values), ±1% of the stated value (or range of values), ±2% of the stated value (or range of values), ±5% of the stated value (or range of values), ±10% of the stated value (or range of values), or other such values. Any numerical value given herein should be understood to encompass the approximate values ​​before and after that value, unless the context contradicts. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical range described herein is intended to encompass all subranges encompassed therein. It should also be understood that when a value is disclosed, values ​​"less than" that value, values ​​"greater than" that value, and possible ranges therebetween, as would be properly understood by one of ordinary skill in the art. For example, when a value "X" is disclosed, values ​​"less than" X and values ​​"greater than or equal to X" (e.g., where X is a number) are also disclosed. It should also be understood that throughout this application, data is provided in several different formats, and that this data represents endpoints and starting points, with ranges covering any combination of these data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, values ​​between 10 and 15 are considered to be disclosed, as well as values ​​greater than, equal to, less than, less than, and equal to 10 and 15. It is also understood that each number between the two specific numbers is also disclosed.For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0106] Although various exemplary embodiments have been described above, any of a number of modifications may be made to the various embodiments without departing from the scope of the invention as set forth in the claims. For example, the order in which the various method steps described are performed may often be changed in alternative embodiments, and in some alternative embodiments, one or more method steps may be skipped altogether. Optional features of the various embodiments of the devices and systems may be included in some embodiments and not in other embodiments. Thus, the above description is primarily for illustrative purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0107] The examples and specific examples contained herein are illustrative, not limiting, of specific embodiments in which the subject matter may be practiced. As noted, other embodiments may be utilized or derived, and structural or logical substitutions or changes may be made without departing from the scope of the present disclosure. Such embodiments of the subject matter may be referred to individually herein or collectively under the term "the present invention," which is merely for convenience and is not intended to spontaneously limit the scope of the present application to any one invention or inventive concept, even if more than one is actually disclosed. Thus, although specific embodiments have been shown and described herein, the specific embodiments shown may be substituted with any configuration designed to achieve the same purpose. The present disclosure is intended to encompass any adaptations or variations of the various embodiments. Combinations of the above-described embodiments, as well as other embodiments not specifically described herein, will become apparent to those skilled in the art upon review of the above description.

Claims

1. A wrist-worn device configured to measure a 12-lead ECG signal, A first wristband portion comprising a first electrode located on the inside of the first wristband portion and a third electrode located on the opposite side of the first wristband portion, A second wristband portion comprising a second electrode located inside the second wristband portion and a fourth electrode located on the opposite side of the second wristband portion, wherein the first wristband portion and the second wristband portion are configured to form a continuous loop worn on the subject's wrist, and further, The second wristband portion is configured such that the first electrode and the second electrode are in contact with the subject's chest and are separated and spread out on the subject's chest so as to be 6 to 14 cm apart from each other in order to measure bioelectrical signals from the subject's chest, the third electrode is configured to measure bioelectrical signals from the subject's right hand, and the fourth electrode is configured to measure bioelectrical signals from the subject's left hand, The system includes a processor configured to process three orthogonal cardiac leads obtained from the first, second, third, and fourth electrodes, The wrist-worn device is configured to operate in a first mode to be worn on the subject's wrist when the first wristband portion is coupled with the second wristband portion, and is configured to operate in a second mode to capture the bioelectrical signal when the first wristband portion is detached from the second wristband portion and the wristband portion is positioned on the subject's chest. Device.

2. The apparatus according to claim 1, further comprising a resistive network that spans between the third electrode and the fourth electrode and forms a center point in the sagittal plane passing through the chest of the subject when the first wristband portion and the second wristband portion are placed against and held against the chest of the subject, wherein the three orthogonal cardiac leads are formed from the first, second, third, and fourth electrodes and the center point.

3. The apparatus according to claim 1, wherein the third electrode is configured to be positioned in contact with the fingers of the subject's first hand, and the fourth electrode is configured to be positioned in contact with the fingers of the subject's second hand, the subject's second hand being different from the subject's first hand.

4. The apparatus according to claim 1, wherein the processor is configured to record and transmit the three orthogonal cardiac leads.

5. The apparatus according to claim 1, wherein the processor is configured to synthesize conventional 12-lead electrocardiogram (ECG) information from the three orthogonal leads.

6. The apparatus according to claim 5, wherein the processor is housed in a housing located between the first wristband portion and the second wristband portion.

7. The apparatus according to claim 2, further comprising a housing surrounding the resistor network and the processor, wherein the housing is located between the first wristband portion and the second wristband portion.

8. The apparatus according to claim 1, further comprising a display configured to display a time output when the first wristband portion and the second wristband portion form a continuous loop worn on the wrist of a subject.

9. The apparatus according to claim 8, wherein the display is configured to indicate the orientation of the apparatus when the apparatus is held against the chest of the subject.

10. The apparatus according to claim 1, further comprising a clasp configured to secure the first wristband portion to the second wristband portion around the wrist of the subject.

11. The apparatus according to claim 1, further comprising a wireless transmitter configured to transmit data from the three orthogonal cardiac leads.

12. The apparatus according to claim 1, wherein the processor is configured to output a command to capture one or more sets of three-lead cardiac signals when the first wristband portion and the second wristband portion are separated.

13. The apparatus according to claim 1, wherein the processor is further configured to monitor the subject's heart signal while the wrist-worn device is worn on the wrist, and to issue an alert if the subject's heart signal exceeds a threshold.

14. The apparatus according to claim 1, which operates as a wristwatch in the first mode.

15. A wrist-worn device configured to measure ECG signals, A first wristband portion including a first electrode and a second electrode, A second wristband portion including a third electrode and a fourth electrode, A processor configured to process three orthogonal cardiac leads obtained from the first, second, third, and fourth electrodes, Includes, The device is configured to operate in a first mode to be worn on the subject's wrist when the first wristband portion is coupled with the second wristband portion to form a continuous loop worn on the subject's wrist, and is further configured to operate in a second mode to capture bioelectric signals when the first electrode is separated from the third electrode by a distance longer than the approximate diameter of the subject's heart, the first wristband portion is detached from the second wristband portion, and the first and second wristband portions are positioned on the subject's chest. Device.

16. The apparatus according to claim 15, wherein the first electrode and the third electrode are configured to contact the chest of the subject when the apparatus is operating in the second mode.

17. The apparatus according to claim 15, further comprising a display configured to display the time when the apparatus is operating in the first mode.

18. The apparatus according to claim 15, wherein the display is configured to indicate the orientation of the apparatus on the chest of the subject when the apparatus is operating in the second mode.

19. The apparatus according to claim 15, wherein, when the apparatus is operating in the second mode, the second electrode is configured to be positioned in contact with the fingers of the subject's first hand, and the fourth electrode is configured to be positioned in contact with the fingers of the subject's second hand, the subject's second hand being different from the subject's first hand.

20. The apparatus according to claim 15, wherein the first electrode is located on the inner surface of the first wristband portion, and the third electrode is located on the inner surface of the second wristband portion.

21. The apparatus according to claim 15, wherein the second electrode is located on the outer surface of the first wristband portion, and the fourth electrode is located on the outer surface of the second wristband portion.

22. The apparatus according to claim 15, wherein the apparatus is configured to receive bioelectric signals from the chest of the subject when operating in the second mode.

23. The apparatus according to claim 15, wherein the apparatus is configured to receive bioelectrical signals from the subject's finger when operating in the second mode.

Images