Classifications

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Definitions

• Handheld electrocardiogram (ECG) devices may be used by a patient (or a medical professional) to capture and record ECG data.
• ECG electrocardiogram
• devices that may be worn continuously that may track ECG have also been proposed, these devices may be uncomfortable and/or may have a low accuracy, particularly if measuring device from regions other than the chest.
• the methods and apparatuses may relate generally to electrocardiography.
• a wrist worn ECG ‘watch’ device or more generally, a w wrist- worn device
• the apparatus is configured so that, when removed from the subject’s wrist, it may assume a configuration that may be easily and accurately placed against the chest and held by the subject to provide three orthogonal leads that may be used to generate a synthetic 12 lead ECG signal that comports with traditional 12-lead ECG signals and may be easily read by those trained in standard electrocardiograms.
• These apparatuses may typically include a strap (which in some examples has multiple strap regions) that and a housing (including a display).
• the apparatus may be a wrist- worn device that may display the time and/or other information (e.g., heart rate/pulse, blood oxygenation, steps/movement, etc.).
• the apparatus may be configured as a smartwatch (e.g., phone, etc.) or any other wrist-worn device.
• the apparatus may include a first configuration that is configured as a wrist- worn strap that may be secured to the subject’s wrist.
• At least two electrodes may be on the inner surface (of the strap and/or housing) and at least two electrodes may be positioned on an outer surface (e.g., on the strap and/or housing).
• the inner electrodes are configured so that when the apparatus is removed from the wrist, and transitioned to a linear configuration the inner electrodes may be separated from each other by a predefined distance, e.g., of greater than 5 cm (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., between 6 and 14 cm (e.g., between 6 and 13 cm, between 6 and 12 cm, between 6 and 11 cm, between 8 and 10 cm, etc.).
• the inner (chest) electrodes may provide cardiac lead signals in combination with the outer (hand/finger) electrodes and may provide a set of orthogonal three-lead cardiac signals.
• a cardiac signal may refer to a voltage produced by a human heart as sensed between selected points on the surface of a subject's body and may also be referred to as cardiac electrical signals (e.g., electrocardiac signals). These cardiac signals may include electrocardiogram (ECG) signals.
• ECG electrocardiogram
• ECG electrocardiogram
• the device may include a first electrode on an inner surface of a first wrist band region, and a second electrode on an inner surface of a second wrist band region (or in some examples a housing).
• the second wrist band region may be on a separate wrist band, or it may be a second region of the same wrist band as the first wrist band region.
• the third and fourth electrodes are configured to be contacted by a finger of a first and second hand, respectively, when the apparatus is held by the subject against the subject’s chest.
• the subject which may be a patient or user, may hold the unbuckled/unfastened apparatus after removing it from the wrist, in a linear configuration against the subject’s chest.
• the apparatus includes a first wrist band region that is part of a first wrist band that is configured to removably couple to a second wrist band region that is part of a second wrist band.
• the device may also include a housing coupled to the first wrist band and the second wrist band, where the first wrist band, the second wrist band, and the housing are configured to form a continuous loop to be worn on a wrist.
• the housing may include electrical circuits 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, wherein the set of three-lead cardiac signals include sufficient information to synthesize (e.g., determine, derive) conventional 12-lead electrocardiogram (ECG) information.
• ECG electrocardiogram
• the housing may also include a processor and/or other circuitry as described herein for recording and/or analyzing an ECG signal.
• the housing may also include circuitry for a clock/watch that may be shown on a display.
• the same processor and circuitry may be used and/or integrated with the circuitry for measuring, analyzing, storing and transmitting the ECG signals as described herein (including the 3 orthogonal leads).
• any of the devices may include a first electrode and a second electrode configured to contact a patient’s chest. Furthermore, 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 five centimeters when the first electrode and the second electrode are receiving electrical signals from a patient’s heart.
• a 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 than the first hand.
• the electrical circuits may be further configured to record one or more sets of three-lead cardiac signals.
• the apparatus including in some cases the electrical circuits within the housing, may be further configured to generate conventional 12-lead ECG information from at least one set of three-lead cardiac signals.
• the apparatus may be configured so that an external or remote processor is used to generate conventional 12-lead ECG information from the recorded signals (e.g., forming 3 orthogonal leads).
• the apparatus may include a housing further comprises a display configured to display instructions to capture one or more sets of three-lead cardiac signals with the device.
• the display may be configured to display the time or other information during operation of the apparatus as a watch when worn encircling the wrist.
• the housing may include a display configured to display instructions to capture one or more sets of three-lead cardiac signals with the device.
• the housing may additionally or alternatively include a speaker configured to provide audible instructions to capture one or more sets of three-lead cardiac signals with the device.
• the device may include a transmitter configured to transmit one or more sets of three-lead cardiac signals to a second device.
• the first wrist band may include conductors to electrically couple the first electrode and the second electrode to the electrical circuits and the second wrist band may include conductors to electrical couple the third electrode and the fourth electrode to the electrical circuits.
• a wearable cardiac diagnosis device may comprise a first wrist band region including a first electrode, a second wrist band region including a second electrode, and a third and a fourth electrode on an outer surface of the apparatus, and the apparatus is configured to removably couple to the first wrist band region to the second wrist band region and to form a continuous band to be worn on a subject’s wrist.
• the apparatus may include a housing may that be coupled to the first wrist band region and the second wrist band region and may include a display, and in some examples electrical circuits configured to operate in a first mode to display time of day information on the display and operate 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.
• the set of three-lead cardiac signals may include sufficient information to synthesize conventional 12-lead electrocardiogram (ECG) information.
• ECG electrocardiogram
• the first electrode and the second electrode may be configured to be separated by at least 5 centimeters and simultaneously contact a chest of a patient.
• 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.
• the housing may further enclose a wireless transmitter configured to transmit three-lead cardiac data when the wearable cardiac diagnosis device is operating in the second mode.
• the apparatuses may be configured to display instructions to capture one or more sets of three-lead cardiac signals when the wearable cardiac diagnosis device is operating in the second mode.
• 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 instructions to capture one or more sets of three-lead cardiac signals when the wearable cardiac diagnosis device is operating in the second mode.
• This patent application may be related to U.S. patent application no. 17/092,152, titled “MOBILE THREE-LEAD CARDIAC MONITORING DEVICE AND METHOD FOR AUTOMATED DIAGNOSTICS,” filed on November 06, 2020, and U.S. patent application no. 17/443,456, titled “ELECTROCARDIOGRAM PATCH DEVICES AND METHODS,” filed on July 26, 2021, and U.S. patent application no. 17/570,368, titled “ELECTROCARDIOGRAM PATCH DEVICES AND METHODS,” filed on January 06, 2022, each of which is herein incorporated by reference in its entirety.
• wrist-worn apparatuses configured to measure 12- lead ECG signals
• apparatus comprising: a first wrist band portion including a first electrode on an inner side of the first wrist band portion and a third electrode on an opposite side of the first wrist band portion; a second wrist band portion including a second electrode on an inner side of the second wrist band portion and a fourth electrode on an opposite side of the second wrist band portion, wherein the first wrist band portion and second wrist band are configured to form a continuous loop worn on a subject’s wrist, and are further configured to be spread apart and positioned on the subject’s chest so that the first electrode and the second electrode are separate by between 6 and 14 cm to measure bioelectric signals from the subject's chest, wherein the third electrode is configured to measure bioelectric signals from the subject's right hand and the fourth electrode is configured to measure bioelectric signals from the subject's left hand; a resistive network forming a central point in a sagittal plane through the subject's chest passing between the third and fourth electrodes when the first wrist band portion
• the third electrode may be configured to be placed in contact with a finger from the subject’s first hand and the fourth electrode is configured to be placed in contact with a finger from the subject’s second hand, the subject’s second hand being different than the subject’s first hand.
• the processor may be configured to record and transmit the three orthogonal cardiac leads.
• the processor may be configured to synthesize conventional 12-lead electrocardiogram (ECG) information from the three orthogonal leads.
• ECG electrocardiogram
• the processor may be housed within a housing positioned between the first wrist band portion and the second wrist band portion.
• any of these apparatuses may include a housing enclosing the resistive network and processor, wherein the housing is positioned between the first wrist band portion and the second wrist band portion.
• Any of these apparatuses may include a display configured to display a time output when the first wrist band portion and the second wrist band form a continuous loop worn on a subject’s wrist.
• the display may be configured to indicate an orientation of the apparatus when held against the subject’s chest.
• Any of these apparatuses may include a clasp configured to secure the first wrist band portion to the second wrist band portion around the subject’s wrist.
• the apparatus may include a wireless transmitter configured to transmit data from the three orthogonal cardiac leads.
• the processor may be configured to output instructions to capture one or more sets of three-lead cardiac signals when the first wrist band portion and second wrist band are spread apart.
• a wrist-worn apparatus configured to measure 12-lead ECG signals may include: a first wrist band portion including a first electrode on an inner side of the first wrist band portion and a third electrode on an opposite side of the first wrist band portion; a second wrist band portion including a second electrode on an inner side of the second wrist band portion and a fourth electrode on an opposite side of the second wrist band portion, wherein the first wrist band portion and second wrist band are configured to form a continuous loop worn on a subject’s wrist, and are further configured to be spread apart and positioned on the subject’s chest so that the first electrode and the second electrode are separate by between 6 and 14 cm to measure bioelectric signals from the subject's chest, wherein the third electrode is configured to measure bioelectric signals from the subject's right hand and the fourth electrode is configured to measure bioelectric signals from the subject's left hand; a housing coupled between the first wrist band portion and the second wrist band portion comprising a display face; a resistive network with the housing and forming a central point in a s
• Also described herein are methods of detecting a cardiac signal from a subject comprising: removing a wrist- worn apparatus from the subject’s wrist; placing a first wrist band portion of the wrist- worn apparatus against the subject’s chest so that a first electrode on an inner surface of the first wrist band portion is in contact with the subject’s chest and a second electrode on an inner surface of a second wrist band portion against is in contact with the subject’s chest, wherein the first electrode is separated from the second electrode by between about 6 cm and 12 cm; placing a finger of a first hand against a third electrode on an outer surface of the wrist-worn apparatus and an finger of a second hand against a fourth electrode of the wrist-worn apparatus; and measuring three orthogonal leads using a resistive network forming a central point in a sagittal plane through the subject's chest passing between the third and fourth electrodes when the first wrist band portion and the second wrist band portion are held against the subject's chest, wherein three orthogonal cardiac leads are formed from the first, second,
• Any of these methods may include removing the wrist- worn apparatus from the subject’s wrist by uncoupling a latch on the wrist-worn apparatus. Any of these methods may include transmitting the three orthogonal cardiac leads from the wrist-worn apparatus to a remote processor to process the three orthogonal leads.
• Placing the finger of the first hand against the third electrode may comprise placing the finger of the first hand against the third electrode on an outer surface of the first wrist band portion and placing the finger of the second hand against the fourth electrode comprises placing the finger of the second hand against the fourth electrode on an outer surface of the second wrist band portion.
• placing the finger of the first hand against the third electrode comprises placing the finger of the first hand against a housing comprising a display, wherein the housing is between the first wrist band portion and the second wrist band portion.
• Processing the three orthogonal leads may comprise processing the using a processor housed within a housing positioned between the first wrist band portion and the second wrist band portion. Any of these methods may include display a time output on a display of the wrist- worn apparatus when the wrist- worn apparatus is worn on the subject’s wrist.
• the methods described herein may include instructing the subject, via an output from the wrist- worn apparatus, how to hold the wrist- worn apparatus against the subject’s chest.
• Any of the methods and apparatuses described herein may be configured to monitor the patient’s cardiac activity while wearing the apparatus on the wrist, and may alert the wearer (or a caregiver) to take a chest recording with the apparatus if the apparatus detects activity that exceeds a monitoring threshold.
• any of these apparatuses may include one or more sensor, e.g., electrodes, optical sensors (e.g., Photoplethysmography or PPG sensors), etc., and may include software, hardware or firmware, e.g., as part of a controller, to monitor the output of the sensor 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 if the sensed signal falls within a range or has a pattern characteristic of a cardiac problem.
• sensor e.g., electrodes, optical sensors (e.g., Photoplethysmography or PPG sensors), etc.
• software, hardware or firmware e.g., as part of a controller, to monitor the output of the sensor 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,
• the apparatus may make an alert on the wrist-worn apparatus, by one or more of; displaying a message (text, graphic, etc.), flashing a light, emitting a tone, etc.
• the apparatus may send a message (e.g., SMS message/text message, email, etc.) to the wearer and/or caregiver.
• the message may include a recommendation or instructions that a “chest recording is advised”.
• any of these apparatuses may include a monitoring mode when the apparatus is worn on the wrist.
• the apparatus may be configured to enter the monitoring mode manually or automatically, such as when the apparatus senses that the device is being worn on the wrist by a user.
• FIG. 1 A illustrates one example of a system for cardiac signal detection and/or diagnosis.
• FIG. IB shows a view of another example of a system for cardiac signal detection.
• FIGS. 2A, 2B and 2C show front, back and axonometric views, respectively, of an example of a handheld device.
• FIG. 2D shows a front view of a device placed against the patient’s body in a recording position.
• FIG. 3 A shows a simple electrical scheme for obtaining a central point (CP) signal by connecting the electrodes of both hands via a simple resistive network consisting of two resistors.
• FIG. 3B shows an electrical scheme for obtaining the CP signal using buffering and averaging via operational amplifiers.
• FIG. 4A shows a front view of an example of a wrist-worn apparatus as described herein.
• FIG. 4B shows a rear view of the wrist- worn apparatus of FIG. 4A.
• FIG. 5A shows a left side view of an example of a wrist-worn apparatus.
• FIG. 5B shows a right side view of the wrist- worn apparatus of FIG. 5 A.
• FIG. 6 shows a schematic diagram depicting placement of a wrist-worn apparatus.
• FIG. 7 shows a flowchart of an example operation for receiving and capturing cardiac signals using a wrist-worn apparatus as described herein.
• FIG. 8 shows a block diagram of a wrist-worn apparatus that may be included with any feasible wrist-worn apparatus described herein.
• Described herein are apparatuses (including devices and systems) and methods for collection, observation, and/or monitoring of cardiac information.
• apparatuses that are configured to be worn on a subject’s wrist as a wristwatch, smartwatch, 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 capture and/or 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, such as a timekeeping or watch function. By performing an auxiliary function, a patient may easily wear or carry the cardiac monitoring device, thereby enabling cardiac monitoring at a variety of locations, many beyond clinical settings.
• cardiac data associated with the three cardiac lead signals may be transmitted to a separate device for monitoring or analysis.
• the three lead cardiac data may be transmitted to a remote unit (server, processor, computer, tablet computer, or the like) for processing, synthesis (to conventional 12-lead data), and/or display to a clinician.
• the handheld device may include a processor that can perform the processing and synthesis and include a display to provide information to a user.
• FIG. 1A illustrates one example of a system 100 for cardiac signal detection and/or diagnosis.
• the wrist-worn apparatuses described herein may perform any or all of the functions illustrated and described with respect to FIGS. 1 A-1B, 2A-2D, and 3A-3B, but may be configured as described herein.
• the system 100 may include a device 2 that includes one or more electrodes mounted, disposed, or coupled to the device (e.g., a housing 3).
• a user e.g., subject, patient or clinician
• the handheld device 2 may process three orthogonal cardiac leads to compare the different times (e.g., baseline vs. assay time).
• a processor (not shown) of the handheld device 2 may further determine if the resulting differential cardiac lead signals (differential with respect to the two or more times the cardiac signals are recorded or “captured”) indicates that a possible cardiac problem is present and can alert the user.
• FIG. IB shows a view of another example of the system 100 including the handheld device 2 incorporating built in electrodes for cardiac signal acquisition, mounted directly on a housing 3 of the handheld device 2 and a remote processor (e.g., a personal computer (PC)) 4 connected via a telecommunication link to the handheld device 2.
• a remote processor e.g., a personal computer (PC)
• the device 2 may further incorporate cardiac signal recording circuitry including one or more amplifiers, analog to digital converters (ADCs) for amplifying the cardiac signals detected by the electrodes, and data storage (e.g., memory) for storing cardiac signal data.
• the device 2 may also include communication circuitry operating on GSM, WWAN, Wi-Fi or any other feasible telecommunication standard for communication with a remote processor 4. In this manner, the device 2 may transmit recorded or captured cardiac signals or cardiac lead information to one or more remote devices such as the remote processor 4.
• the device 2 may include visual and/or audio circuits or devices (e.g., display, monitor, speaker, etc.) for communicating diagnostic information to the user.
• the device 2 may communicate with the remote processor 4 via integrated communication circuitry.
• 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, producing diagnostic information and for transmitting the diagnostic information back to the device 2 for communicating the diagnostic information to the user via a speaker producing characteristic sounds or voice messages or in the form of graphical information via the visual and/or audio circuits or devices included with the device 2.
• the system 100 may be capable of performing automated detection of a cardiac condition on the basis of a 3 -lead system and may not require interpretation of the diagnostic information by a specialist.
• FIGS. 2A, 2B and 2C show front, back and axonometric views, respectively, of an example of a device 200.
• the device 200 may be an example of the device 2 of FIGS. 1A and IB.
• FIG. 2A shows the front view of the device 200 in a recording position as held by a patient.
• the device 200 may include the housing 3, and electrodes C, D, and G disposed on a front surface 6.
• FIG. 2B shows the back view of the device 200. As shown, electrodes A and B may be disposed on a back surface 5 of the housing 3.
• FIG. 2C shows the axonometric view of the device 200.
• This view shows the electrodes C, D, and G disposed on the front surface 6 of the housing 3 and electrodes A and B disposed on the back surface 5 of the housing 3.
• the G electrode may be referred to as a ground electrode.
• the device 200 may also include additional electrodes to contact the patient hidden in this view.
• the housing 3 of the handheld device 200 may incorporate the electrodes A, B, C, D, and G arranged in such an arrangement that enables recording of three electrocardiogram (ECG) lead signals.
• ECG electrocardiogram
• the electrodes, A and B are preferably arranged to cover a distance (e.g., be separated by) greater than at least 5 centimeters (cm), and preferably greater than about 10 cm.
• a distance e.g., be separated by
• cm centimeters
• One reason for having such a spatial arrangement is to achieve a distance greater than an approximate diameter of the heart muscle which is needed to provide and/or improve possible lead orthogonality.
• the handheld device in this example may include two other electrodes C and D, mounted on the front surface 6 substantially parallel and opposite to 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 fingers of the left and right hands respectively.
• the fifth electrode G may serve as a grounding electrode and is mounted on the front surface 6 for pressing with a left-hand finger.
• FIG. 2A there is shown a view of one example of the device in a recording position.
• the patient may place his left hand so that patient’s index and middle finger contact electrodes C and G respectively.
• the patient may position and press the handheld device 200 against his chest so that the chest electrodes A and B contact his chest in the manner shown in FIG. 2D for producing tight contact between chest and the device. This may produce enough pressure for holding the device against the chest.
• a finger of the right hand (or any other part of the right hand) may press the electrode D mounted on the front surface 6 of the housing 3.
• FIG. 2D there is shown a front view of the device 200 placed against the patient’s body in a recording position according to one example of the invention.
• the center of the device 200 may be placed closely above the center of the heart so that the chest electrodes A and B are approximately on the midclavicular line (the vertical line passing through the midpoint of the clavicle bone), and the lower chest electrode B is at about the level of the lower end of the sternum.
• FIG. 3 A shows a simple electrical scheme for obtaining a central point (CP) signal by connecting the electrodes of both hands via a simple resistive network consisting of two resistors.
• FIG. 3B shows an electrical scheme for obtaining the CP signal using buffering and averaging via operational amplifiers.
• the CP signal may be used to provide an arbitrary reference (e.g., a reference voltage) that may be used in conjunction with signals from the electrodes A, B, C, D, E, and G to generate three orthogonal cardiac lead signals.
• the three orthogonal cardiac lead signals may be used to generate a conventional 12-lead ECG signals.
• One method to transform the three orthogonal cardiac signals is described at least in U.S.
• the apparatus 200 may be implemented as a watch.
• the watch may be worn by the subject and may be used whenever convenient to capture, record, and/or transmit cardiac signals or data.
• the apparatus 200 may be a wearable cardiac diagnosis device.
• FIGS. 4-6 One such implementation is described with respect to FIGS. 4-6.
• the use of a resistive network is optional. Any of the apparatuses described herein may be used without a resistive network or may not include a resistive network as described.
• the apparatus 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.
• FIG. 4A shows a front view of a wrist-worn apparatus 400.
• the wrist-worn apparatus 400 may be implemented as a wrist-worn watch.
• the wrist-worn apparatus 400 may include a first wrist band portion 410, a housing 420, and a second wrist band portion 430.
• the first wrist band portion 410 may be removably coupled to the second wrist band portion 430 by a clasp, latch, etc., thereby enabling the patient to wear the wrist-worn apparatus 400 on the subject’s wrist.
• the wrist- worn apparatus may be configured to be slightly biased (as shown in FIGS. 5A-5B) in the wrist-worn configuration or may be relatively flat in the linear (unlatched) configuration.
• the biased, slightly concave configuration shown in FIGS. 5A-5B may help maintain contact with the apparatus against the patient’s chest.
• the housing 420 may include a display 421 that may be used to provide information to the patient.
• the display 421 may provide conventional watch related information such as time of day, date, and other chronometer information.
• the apparatus may be configured to provide instructions on using the wrist-worn apparatus to record ECG signals.
• the wrist-worn apparatus may be configured to operate in a second mode to record ECG signals, and the display 421 may provide information related to ECG information, including instructions on how to position and use the apparatus to record ECG information.
• the display 421 may show images regarding the placement of the wrist-worn apparatus 400 on the patient’s body.
• the display 421 may show usage instructions and/or information regarding the capture and analysis of a patient’s cardiac lead signals.
• the housing 420 may enclose a speaker (not shown) that may provide acoustic information to the patient.
• the speaker may provide audible directions regarding the usage or placement of the wrist-worn apparatus 400.
• the speaker may provide tones associated with capturing cardiac lead signals.
• the housing 420 may enclose a transceiver 422 that may be configured to communicate with any other feasible device.
• the housing 420 may enclose a Bluetooth transceiver that may be used to communicate cardiac signal data with any feasible Bluetooth enabled device, such as a smart phone, or the like.
• the housing 420 may enclose a Wi-Fi transceiver that may be used to communicate cardiac signal data with any feasible Wi-Fi enable device including computers (laptop computers, desktop computers, tablet computers, or the like), Wi-Fi access points , smart phones, etc.
• the housing 420 may enclose a cellular transceiver that may be used to communicate cardiac signal information via any feasible cellular network.
• the cardiac data may be analyzed on a remote processor (such as the remote processor 4 of FIG. IB).
• the cardiac data may directly or indirectly be transmitted to the remote processor 4 using the transceiver 422 included within the housing 420.
• the housing 420 may enclose a processor 423.
• the processor 423 may analyze any captured and/or recorded cardiac lead signals.
• any operations that may be performed by the remote processor 4 may be performed by the processor 423.
• the circuitry and/or processor may be integrated into the strap(s), rather than, or in addition to, a housing.
• the first wrist band region 410 may include a first electrode 411 and a second electrode disposed (shown in FIG. 4B) on the inside surface of the first wrist band portion 410 and the second wrist band portion 430.
• the inside surface may refer to the surface configured to be worn against the wrist when in the first, wrist-worn configuration, which may also be configured to be held against the chest in the ECG collection configuration.
• the second electrode may be on the second wrist band region 430 or it may be on the housing 420 (not shown).
• the third electrode 431 and a fourth electrode 432 may be disposed on the opposite side of the apparatus, such as the opposite (outward-facing) sides of the first wrist band region 410 and the second wrist-band region, and/or on the housing.
• portions of the patient’s body may contact the first electrode 411 and the second electrode 431 in order for the processor 423 to determine three orthogonal cardiac lead signals.
• 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.
• FIG. 4B shows a rear view of the wrist-worn apparatus 400.
• the third electrode 412 may be disposed on the first wrist band region 410 opposite the first electrode 411.
• the fourth electrode 432 may be disposed on the second wrist band region 430 opposite the third electrode 431.
• the wrist-worn apparatus 400 may be placed on the chest of the patient thereby placing the second electrode 412 and the fourth electrode 432 in contact with the chest.
• first electrode 411 may be separated from the second electrode 431 by a distance of at least 5 centimeters (cm). In some cases, the separation distance may be at least 10 cm so that the second electrode 412 and the fourth electrode 432 may span a distance larger than a typical heart muscle.
• the first electrode 411 and the second electrode 431 may receive electrical signals from the patient’s heart.
• the patient may be guided by the wrist-worn apparatus 400 to correctly place the wrist- worn apparatus 400 on an optimal position on the chest so that the first electrode 411 and the second electrode 431 may capture and/or detect cardiac signals from the patient’s heart.
• the wrist- worn apparatus 400 may provide one or more images on the display 421 and/or provide audible instructions through a speaker 425 to guide placement of the wrist-worn apparatus 400 on the patient.
• a back of the housing 420 may act as an additional or alternative electrode.
• the back of the housing 420 may perform the functions associated with a ground electrode.
• the housing 420 may enclose circuitry 424 to capture and/or record cardiac lead signals from one or more of the first, second, third, and fourth electrodes 411, 431, 412, and 432 respectively.
• the circuitry 424 may capture and/or record cardiac lead signals from a ground electrode (such as the back of the housing 420, or any of the described electrodes performing the function of the ground electrode.
• the first electrode 411, the second electrode 431, the third electrode 412, and the fourth electrode 432 (and in some cases the housing 420) may be coupled to circuitry 424 to capture and/or record cardiac lead signals.
• the circuitry 424 may include any number of feasible filters, amplifiers, analog- to-digital converters, memory, and the like to capture and/or record cardiac signals.
• the processor 423 in conjunction with the circuitry 424, may receive data from one or more coupled electrode and determine one or more sets of orthogonal three-lead cardiac signals.
• the processor 423 can record sensor data from one or more electrodes, three-lead cardiac data, or synthesized (e.g., derived) 12-lead cardiac data (e.g., 12-lead electrocardiogram (ECG) information).
• the processor 423 in conjunction with the transceiver 422 may transmit cardiac data (including orthogonal three-lead cardiac signal data) to another device for further processing or analysis.
• the processor 423 or a separate device may process captured or recorded cardiac data to synthesize conventional 12- lead cardiac data.
• the three-lead cardiac signal data may include all the information sufficient to synthesize conventional 12-lead cardiac data.
• the processor 423 can process cardiac signal data collected through electrodes and the circuitry 424 and determine that placement of the wrist-worn apparatus 400 is incorrect. The processor 423 may also instruct the user to correct placement of the wrist-worn apparatus 400 and/or correct placement of fingers on any feasible electrode. For example, the processor 423 can provide the instructions to the user through the speaker 425 and/or a display.
• FIG. 5A shows a left side view of a wrist-worn apparatus 500.
• the wrist-worn apparatus 500 may include a first wrist band region 510, a housing 520, and a second wrist band region 530.
• the wrist-worn apparatus 500 may be an example of the wrist-worn apparatus 400 of FIG. 4A and 4B.
• the first wrist band region 510 may be an example of the first wrist band 410
• the housing 520 may be an example of the housing 420
• the second wrist band region 530 may be an example of the second wrist band 430.
• the first wrist band region 510 may include a first electrode 511 and a third electrode 512.
• the second wrist band region 530 may include a second electrode 531 and a fourth electrode 532.
• FIG. 5B shows a right side view of the wrist-worn apparatus 500.
• the wrist- worn apparatus 500 includes the first wrist band region 510, the housing 520, and the second wrist band region 530.
• the back of the housing 520 may perform as a fifth electrode.
• the first, second, third, and fourth electrodes 511, 531, 512, and 532 may be electrically coupled to circuits or the like within the housing 520 by one or more conductors (wires, or the like) included with, or embedded within the first wrist band 510 and the second wrist band 530.
• the wrist-worn apparatus 500 may operate in a first mode as a watch or any other similar or feasible time keeping device (e.g., a chronometer).
• the first wrist band region 510 may be removably coupled to the second wrist band region 530 to form a continuous loop with the housing 520.
• the wrist-worn apparatus 500 may be easily and comfortably worn on a user’s or patient’s wrist.
• the strap (“wrist band”) shown in FIGS 4A-4B and 5 A-5B includes two parts, each connected to the housing, in some examples a single strap or band is included and may be coupled to a housing or the housing may be integrated into the strop or band.
• the apparatus may include a first region and a second region that are both on the same band or strap.
• the wrist- worn apparatus 500 may operate in a second mode to capture one or more cardiac signals through one or more electrodes.
• the wrist bands may be uncoupled from each other and the wrist- worn apparatus may be placed on the patient’s chest.
• the second electrode 531 and the first electrode 511 (and optionally the housing 520) may be placed in contact with the chest of the patient.
• 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., between 5 cm and 14 cm, between 6 cm and 12 cm, between 8 cm and 12 cm, etc.), particularly when the wrist-worn apparatus 500 is placed on the patient’s chest.
• a processor may capture, record, and in some cases analyze the cardiac signals.
• the processor may synthesize conventional 12-lead ECG information from cardiac signals received by one or more electrodes of the wrist-worn apparatus 500.
• the wrist-worn apparatus 500 can transmit data associated with the captured cardiac signals to another device thereby enabling remote monitoring and/or analysis of the patient’s cardiac health.
• the device receiving the data may synthesize the conventional 12-lead ECG information.
• FIG. 5B shows a right side view of the wrist-worn apparatus 500.
• the wrist-worn apparatus 500 includes the first wrist band region 510, the housing 520, and the second wrist band region 530.
• the first wrist band region 510 includes the first electrode 511 and the second electrode 512.
• the second wrist band region 530 includes the second electrode 531 and the fourth electrode 532.
• FIGS. 4A-4B and 5A-5B multiple adjacent electrodes are shown on the inner surface 529 and outer surface 540, though in some examples on single electrodes are used. Alternatively or additionally, multiple electrodes may be used and the overall system may be filtered
• FIG. 6 shows a schematic diagram 600 depicting placement of a wrist-worn apparatus 610 as described in FIGS. 4A-4B and 5A-5B.
• the wrist-worn apparatus 610 may be placed on (over) the patient’s 620 left chest such that the electrodes contacting the chest are approximately straddling the patient’s heart.
• Fingers from the patient’s hands may be placed in contact with electrodes.
• 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 a different wrist band.
• the wrist-worn apparatus 610 may guide the patient in optimizing the placement of the wrist-worn apparatus on the patient 620.
• a processor within the wrist- worn apparatus 610 may receive one or more cardiac signals, particularly from electrodes in contact with the patient’s chest. The wrist- worn apparatus 610 may analyze these signals and determine that the placement of the wrist-worn apparatus 610 is incorrect. In response, the wrist-worn apparatus 610 may display placement instructions or, in some cases, may provide audible instructions to guide the patient to correct the placement of the wrist-worn apparatus 610.
• the form of the apparatus shown in FIGS. 4A-4B, 5A-5B and 6 is just one example of a wrist-worn apparatus.
• the wrist-worn apparatus does not include a watch body having a watch face but is a single continuous strap. The strap may include the first portion and second portion as described herein. In some examples a body may be included but may not be configured as a watch body.
• FIG. 7 shows a flowchart 700 of an example operation for receiving and capturing cardiac signals using a wrist-worn apparatus.
• the wrist-worn apparatus may be the wrist-worn apparatus 400 of FIGS. 4A and 4B, the wrist-worn apparatus 500 of FIGS. 5 A and 5B., the wrist- worn apparatus 610 of FIG. 6, or any other feasible wrist- worn apparatus.
• the operation begins as wrist-worn apparatus detects cardiac signals in block 702.
• the wrist-worn apparatus may detect cardiac signals for a set of three-lead cardiac signals through included electrodes.
• the cardiac signals may be detected through one or more electrodes. If no cardiac signals are detected, then the operation may continue to periodically (or continuously) check to see if any cardiac signals are detected.
• the wrist-worn apparatus may read and/or process the ECG (cardiac) signals.
• the detection of cardiac signals may cause the wrist-worn apparatus to transition from a first mode (e.g., a time keeping mode operating as a watch, for example) to a second mode to capture cardiac signals.
• a first mode e.g., a time keeping mode operating as a watch, for example
• 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 apparatus may save power by operating in a low-power watch mode instead of a relatively higher power mode to capture and/or process cardiac signals.
• the wrist-worn apparatus can read (capture) ECG (cardiac) signals.
• ECG cardiac
• the wrist-worn apparatus can capture cardiac signals through one or more included electrodes.
• the wrist-worn apparatus can provide signal processing to the captured cardiac signals.
• the cardiac signals may be buffered, amplified, digitized (through one or more analog-to-digital converters, for example), or the like.
• the processed cardiac signals may be stored in a memory.
• a 12-lead ECG information may be synthesized from the processed cardiac signal data. This operation may be optional, as denoted by dashed lines in FIG. 7.
• the wrist-worn apparatus may include a processor that may synthesize (derive, determine) 12-lead ECG information from processed cardiac signal data, including processed cardiac signal data that may include three-lead cardiac signal data.
• the wrist-worn apparatus may display 12-lead ECG information data on a display. In some examples, the display may be separate from the wrist-worn apparatus.
• the wrist-worn apparatus may wirelessly transmit the processed cardiac signal data in block 714.
• the wrist-worn apparatus may transmit captured three-lead cardiac signal data directly or indirectly to one or more remote devices.
• the remote devices can synthesize a 12-lead ECG information.
• the 12-lead ECG information may be analyzed or monitored by a clinician to ascertain the cardiac health of the patient.
• FIG. 8 shows a block diagram of an example wrist-worn apparatus 800.
• the wrist- worn apparatus 800 may include electrodes 810, processing circuits 815, a wireless transceiver 820, a processor 330, a memory 840, input/output devices 850, and time keeping circuits 860.
• the electrodes 810 may be included within the wrist- worn apparatus 800, or external to the wrist-worn apparatus 800, such as disposed on one or more wrist bands (not shown).
• the electrodes 810 may be coupled to processing circuits 815.
• the processing circuits may include buffers, amplifiers, analog-to-digital converters, or the like to capture and/or digitize cardiac signals received by the electrodes 810.
• the processing circuits 815 may be coupled to the processor 830.
• the wireless transceiver 820 which may include circuits and/or device to provide wireless communications with any other feasible device, is coupled to the processor 830.
• the wireless transceiver 820 may include Bluetooth, Wi-Fi, cellular, or any other feasible wireless communication circuits.
• the processor 830 may transmit captured cardiac signal data through the wireless transceiver 820 to other devices that may, in turn, synthesize conventional 12-lead ECG information data therefrom.
• the input/output devices 850 which is coupled to the processor 830, may include visual and/or audio devices to display or provide audible feedback or information to a patient or clinician.
• the time keeping circuits 860 which are also coupled to the processor 830, may be used to provide time of day information that may be displayed on a display, such as one included within the input/output devices 850.
• the processor 830 which is also coupled to the memory 840, may be any one or more suitable processors capable of executing scripts or instructions of one or more software programs stored in the wrist-worn apparatus 800 (such as within memory 840).
• the memory 840 may include a data storage region 842 that may be used to locally store cardiac signal data collected from the electrodes 810.
• the electrodes 810 may receive cardiac signals that are processed by the processing circuits 815 and then stored in the data storage region 842.
• the memory 840 may also include a non-transitory computer-readable storage medium (e.g., one or more nonvolatile memory elements, such as EPROM, EEPROM, Flash memory, a hard drive, etc.) that may store the following software modules: a Cardiac signal synthesis module 844 to synthesize 12-lead ECG information.
• a Cardiac signal synthesis module 844 to synthesize 12-lead ECG information.
• Each software module includes program instructions that, when executed by the processor 830, may cause the wrist-worn apparatus 800 to perform the corresponding function(s).
• the non-transitory computer- readable storage medium of memory 840 may include instructions for performing all or a portion of the operations described herein.
• the processor 830 may execute the 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 region 842.
• 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 region 842 and generate 12-lead ECG information based thereon.
• One method to transform the three orthogonal cardiac signals into 12- lead ECG information is described at least in U.S. Patent Application 17/494,806 and incorporated by reference herein.
• any of these apparatuses may include sensing for cardiac events when the device is worn on the wrist, in order to trigger an alert to the user or a caregiver (e.g., doctor, nurse, technician, family member, etc.) to use the device to take readings as described above.
• a caregiver e.g., doctor, nurse, technician, family member, etc.
• any of these apparatuses may include wrist-worn monitoring using one or more sensors.
• the sensors may be the electrode(s) 810 used for measuring from the chest, while in other apparatus examples separate, dedicated sensors 846 may be used.
• one or more Photoplethysmography (PPG) sensors on the apparatus, such as on the strap and/or housing may be used.
• PPG Photoplethysmography
• the processing circuits 815 may be configured to process signals when the device is worn on the wrist of the patient and may periodically or continuously monitor the patient based on the signal(s) sensed.
• the signals may be detected from sensors on different portions of the inner surface of the strap and/or housing (e.g., watch housing) to determine which sensor(s) are detecting the presence of the patient and a cardiac signal. For example, if PPG is used, the PPG signal may detect the heartbeat and the regularity of the heartbeat may be determined.
• a time-domain analysis of the signal(s) may be done to extract features that may indicate cardiac problems.
• the apparatus may use extracted features to determine if the patient is in or is likely to be in, cardiac distress. Determination of diseased vs. healthy states may be performed by the processing circuits 815 and/or processor 830, based on e.g., decision trees, discriminant analysis, logistic regression, etc.
• the apparatus may provide continuous (or periodic) monitoring and recording as described above and may denoise the signal and/or may preprocess (e.g., filter) the signal or use the raw signal to determine heart rate variability (HRV). If the HRV exceed a threshold, which may be adjusted for the patient specifically or may be generic, the apparatus may trigger the alert.
• HRV heart rate variability
• any of the methods (including user interfaces) described herein 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 capable of being executed by a processor (e.g., computer, tablet, smartphone, etc.), that when executed by the processor causes the processor to control perform any of the steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, or the like.
• any of the methods described herein may be performed, at least in part, by an apparatus including one or more processors having a memory storing a non-transitory computer-readable storage medium storing a set of instructions for the processes(s) of the method.
• 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 contained within the modules described herein.
• these computing device(s) may each comprise at least one memory device and at least one physical processor.
• memory or “memory device,” as used herein, generally represents any type or form of volatile or non-volatile storage device or medium capable of storing data and/or computer-readable instructions.
• a memory device may store, load, and/or maintain one or more of the modules described herein.
• Examples of memory devices comprise, without limitation, Random Access Memory (RAM), Read Only Memory (ROM), flash memory, Hard Disk Drives (HDDs), Solid-State Drives (SSDs), optical disk drives, caches, variations or combinations of one or more of the same, or any other suitable storage memory.
• processor or “physical processor,” as used herein, generally refers to any type or form of hardware-implemented processing unit capable of interpreting and/or executing computer-readable instructions.
• a physical processor may access and/or modify one or more modules stored in the above-described memory device.
• Examples of physical processors comprise, without limitation, microprocessors, microcontrollers, Central Processing Units (CPUs), Field-Programmable Gate Arrays (FPGAs) that implement softcore processors, Application-Specific Integrated Circuits (ASICs), portions of one or more of the same, variations or combinations of one or more of the same, or any other suitable physical processor.
• the method steps described and/or illustrated herein may represent portions of a single application.
• 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, may cause the computing device to perform one or more tasks, such as the method step.
• 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 recited 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 by executing on the computing device, storing data on the computing device, and/or otherwise interacting with the computing device.
• computer-readable medium generally refers to any form of device, carrier, or medium capable of storing or carrying computer-readable instructions.
• Examples of computer-readable media comprise, without limitation, transmission-type media, such as carrier waves, and non-transitory-type media, such as magnetic-storage media (e.g., hard disk drives, tape drives, and floppy disks), optical -storage media (e.g., Compact Disks (CDs), Digital Video Disks (DVDs), and BLU-RAY disks), electronic-storage media (e.g., solid-state drives and flash media), and other distribution systems.
• transmission-type media such as carrier waves
• non-transitory-type media such as magnetic-storage media (e.g., hard disk drives, tape drives, and floppy disks), optical -storage media (e.g., Compact Disks (CDs), Digital Video Disks (DVDs), and BLU-RAY disks), electronic-storage media (e.g., solid-state drives and flash
• the processor as described herein can be configured to perform one or more steps of any method disclosed herein. Alternatively or in combination, the processor can be configured to combine one or more steps of one or more methods as disclosed herein.
• the device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
• the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
• first and second may be used herein to describe various features/elements (including steps), 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 feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
• any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and/or steps may alternatively be exclusive, and may be expressed as “consisting of’ or alternatively “consisting essentially of’ the various components, steps, sub-components or sub-steps.
• a numeric value may have a value that is +/- 0.1% of the stated value (or range of values), +/- 1% of the stated value (or range of values), +/- 2% of the stated value (or range of values), +/- 5% of the stated value (or range of values), +/- 10% of the stated value (or range of values), etc.
• Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value " 10" is disclosed, then “about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein.

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• 2022
  • 2022-04-21 US US17/726,497 patent/US11529085B1/en active Active
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