Systems, devices, and methods for determining physiological information, including handheld and implantable devices

Abstract

Described herein are systems, devices, and methods for capturing and analyzing physiological information of a user. In some embodiments, systems, devices, and methods described herein include an external device and / or an implantable device. The external device and / or implantable device can include one or more sensors configured to measure signals of one or more physiological parameters of a user. The physiological parameters can be used to assess cardiopulmonary parameters of the user.

Description

Attorney Docket No.: CRDS-006 / 01WO 348698-2033 SYSTEMS, DEVICES, AND METHODS FOR DETERMINING PHYSIOLOGICAL INFORMATION, INCLUDING HANDHELD AND IMPLANTABLE DEVICES CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and benefit of U.S. Provisional Patent Application No. 63 / 690,243, titled, “SYSTEMS, DEVICES, AND METHODS FOR DETERMINING PHYSIOLOGICAL INFORMATION, INCLUDING WEARABLE AND IMPLANTABLE DEVICES,” filed September 3, 2024, the disclosure of which is incorporated herein by reference. TECHNICAL FIELD

[0002] Devices, systems, and methods disclosed herein relate to health systems and methods, including a wearable system and method for assessing heart health. BACKGROUND

[0003] Heart failure (HF) is a debilitating disorder contributing each year in the U.S. to nearly 300,000 deaths and more than 800,000 hospitalizations. The cost associated with HF exceeds $30 billion per year with an expected increase to $70 billion by 2030. One of the driving factors of the cost and mortality of HF is high rate of rehospitalization of the patients following initial hospitalization. As a result, improved approaches are needed for optimally managing the patients at home to reduce rehospitalizations and thereby improve HF care while reducing costs.

[0004] The clinical strategy that has demonstrated the best outcomes in managing patients with HF at home involves the measurement of pulmonary artery (PA) pressures using an implantable device, and titrating therapies according to the presence of elevated PA pressures (indicating congestion or imminent decompensation). While the approach to detecting hemodynamic congestion with PA pressure is sound and validated in large randomized clinical trials, the cost and complications associated with the surgical procedure render the approach only suitable to a small fraction of patients with HF.

[0005] Therefore, what is needed is technology enabling the detection of elevated PA pressures or equivalent, such as pulmonary capillary wedge pressures (PCWP), allowing patients with HF to be monitored and therapies to be personalized for effective care and improved outcomes such as reduced number of hospitalizations and better quality of life. 1323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033

[0006] Wearable devices may provide a convenient way to capture physiological signals or characteristics of a user. Signals from sensors used to measure physiological characteristics, such as photoplethysmography (PPG) sensors, electrocardiogram (ECG) sensors, and / or seismocardiogram (SCG) sensors, can often include noise associated with the sensor (e.g., high frequency noise, noise from movement, noise due to improperly positioned sensors, etc.). Because of the noise, physicians, when using sensor measurements to support decisions, often are not confident in the measurements from the sensors.

[0007] Current methods for providing decision support using wearable technology provide limited information and may be unreliable. Current methods may also be difficult to generate across multiple types of data and / or sensors because small differences in data collection approach, dataset demographic differences, and ground truth collection methods can impact the datasets and therefore outputs or inferences derived from the datasets.

[0008] Thus, there is a need for devices and methods that can process and analyze physiological information, provide insights into reliability of such information or analysis, and / or present more robust or comprehensive information associated with such information or analysis. SUMMARY

[0009] Described herein are systems, devices, and methods for capturing and analyzing physiological information of a user.

[0010] In some embodiments, a system includes: an implantable device configured to be implanted in a chest of a user, the implantable device including a first set of one or more sensors configured to measure a first set of one or more physiological parameters of the user; an external device configured to be positioned against the chest of the user near the implantable device such that the implantable device is configured to transmit signals of the first set of physiological parameters to the external device, the external device including a second set of one or more sensors configured to measure a second set of one or more physiological parameters of the user; and a processor operatively coupled to the first set of sensors and the second set of sensors, the processor configured to: receive, from at least one sensor of the first set of sensors or the second set of sensors, a signal indicative of the implantable device and the external device being within a predetermined distance from one another; in response to receiving the signal, obtain the signals of the first set of physiological parameters and signals of the second set of physiological parameters; and process the signals of the first set of 2323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 physiological parameters and the signals of the second set of physiological parameters to determine one or more cardiopulmonary parameters of the user.

[0011] In some embodiments, a system includes: a sensing device configured to be gripped by a hand of the user, the sensing device including: a housing including a grip and a surface configured to contact a chest of the user; a first sensor disposed on a surface of the housing near the grip such that a portion of the hand of the user contacts the first sensor when the hand is gripping the sensing device; and a second sensor disposed on the surface configured to contact the chest of the user such that the second sensor contacts the chest of the user when the user places the sensing device against the chest of the user; and a processor operatively coupled to the sensing device, the processor configured to: receive, from the sensing device, signals of one or more physiological parameters of the user; and process the signals of the one or more physiological parameters of the user to determine one or more cardiopulmonary parameters of the user. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] FIG. 1 is a block diagram of a network of device for capturing and / or analyzing physiological data of a subject, according to an embodiment.

[0013] FIG. 2 depicts an example of a handheld device, according to embodiments.

[0014] FIG. 3 depicts various positions of an implanted sensing device, according to embodiments.

[0015] FIG. 4 depicts an implanted device interacting with a chest device, according to embodiments.

[0016] FIG. 5 depicts a handheld sensing device, according to embodiments.

[0017] FIG. 6 is a flow chart illustrating a method of capturing and / or analyzing physiological data using a handheld sensing device, according to embodiments.

[0018] FIG. 7 is a flow chart illustrating a method of capturing and / or analyzing physiological data using an implantable sensing device, according to embodiments.

[0019] FIG. 8 is a block diagram of an implantable sensing device and an external device for capturing and / or analyzing physiological data of a subject, according to embodiments.

[0020] FIG. 9 is a block diagram of a handheld sensing device for capturing and / or analyzing physiological data of a subject, according to embodiments. 3323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 DETAILED DESCRIPTION

[0021] Systems, apparatuses, and methods described herein relate to health systems and monitoring. In some embodiments, systems, devices and methods are configured to assess heart health of a user. In some embodiments, systems and devices include a wearable device configured to measure one or more of an electrocardiogram (ECG) signal, a seismocardiogram (SCG) signal, a photoplethysmogram (PPG) signal, or other physiological information of a user. In some embodiments, systems and devices include an implantable device, such as one that is implanted in the subcutaneous space such that the implantation procedure is simple and minimally invasive, configured to measure one or more of an ECG signal, a SCG signal, a PPG signal, or other physiological information of a user. In some embodiments, systems and devices include one or more sensing device(s) (e.g., implantable, wearable, and / or handheld sensing device) that is configured to interface with a secondary device (e.g., a second sensing device, a user device, an external device, etc.) to measure one or more of a ECG signal, a SCG signal, a PPG signal, or other physiological information of a user.

[0022] In some embodiments, multiple devices (e.g., two devices) can be used to transform physiological data obtained from one internal or external device (i.e., ECG, SCG, PPG data) to the data obtained by another internal or external device. For example, simultaneous data can be captured using multiple devices during an initial calibration period to learn a multi- directional relationship for future data transformations between devices. The relationship can be used as a translation medium or adapter between devices when data from one device is absent to enable algorithms and / or machine learning models trained on data from a single device to be interoperable. Systems and Devices

[0023] FIG. 1 is a block diagram of a network of devices, including systems and devices for measuring physiological information of a user, according to an embodiment. Such systems and devices can be configured to measure physiological information of a user (e.g., a ECG signal, a SCG signal, or a PPG signal) and / or to determine a health status of the user (e.g., a heart health of the user).

[0024] The system and devices for measuring physiological information of a user can include a sensing device 110. In some embodiments, the sensing device 110 can include a processor, memory, and one or more sensors, and optionally a communications interface. The memory can be, for example, a random-access memory (RAM), a memory buffer, a hard drive, a flash memory, a read-only memory (ROM), an erasable programmable read-only memory 4323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 (EPROM), and / or the like. The processor can be, for example, a hardware based integrated circuit (IC), or any other suitable processing device configured to run and / or execute a set of instructions or code. The memory can store, for example, one or more software programs and / or code that can include instructions to cause the processor to perform one or more processes, functions, and / or the like. In some embodiments, the sensing device 110, via the one or more sensors, can be configured to measure or acquire signals associated with one or more of blood volume, volume changes, electrical activity, cardiac vibrations, ECG, heart rate, pulse rate, PPG, blood pressure, blood flow, SCG, muscle electrical potential, nerve electrical potential, temperature, brain waves, motion, measures of activity, number of steps taken, location, acceleration, pace, distance, altitude, direction, velocity, speed, time elapsed, time left, and / or the like. In some embodiments, the sensing device 110 can be configured to collect data of the user at predetermined times and / or time intervals. In some embodiments, the sensing device 110 can be configured to collect data of the user during predetermined activities (e.g., during rest and / or sleep, or other times when a user may be less likely to be moving). The physiological signal(s) acquired by the sensing device 110 can be inputted into a processor (e.g., processor of sensing device 110, and / or processor of any of the other devices depicted in FIG. 1) for outputting estimates of filling pressures (e.g., PCWP), other hemodynamic parameters (e.g., cardiac output), and / or other parameters associated with a patient’s cardiovascular and / or respiratory systems (e.g., cardiopulmonary parameters). The sensing device 110 can be configured to send physiological signal(s), information regarding one or more cardiopulmonary parameters, and / or other information to one or more other devices (e.g., secondary device 120, compute device 140, server 150, database(s) 160, etc.). In some embodiments, the sensing device 110 can have a communications interface that can be configured to receive information and / or send information to compute device 140 and / or other devices depicted in FIG. 1. The communications interface can be a wired or wireless communications interface. The communications interface can, for example, be configured to send physiological signal(s)captured by the sensor(s) to the compute device 140, such that the compute device 140 can be configured to further process and / or analyze the physiological signal(s). In some embodiments, the communications interface can receive data, signals, and / or instructions from the compute device 140. Wearable Sensing Devices

[0025] In some embodiments, the sensing device 110 can be configured to be a wearable device, e.g., where the device is coupled to (e.g., adhered to or attached to) a portion of a subject. For example, the sensing device 110 can be attached to a chest wall of the subject, such 5323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 as with electrodes (e.g., dry electrodes), adhesives, a strap, a belt, an article of clothing (e.g., a shirt, a band, etc.), or other attachment mechanisms. Suitable examples of a wearable device that is attached to the chest wall are described in U.S. Patent Application Publication No. 2023 / 0293082, titled “Systems and methods for measuring hemodynamic parameters with wearable cardiovascular sensing,” filed May 22, 2023, and U.S. Patent Application Publication No. 2025 / 0082211, titled “Multi-wavelength photoplethysmogram system and method with motion artifact detection,” filed December 20, 2022, the disclosures of each of which are incorporated herein by reference. In some embodiments, the sensing device 110 can be coupled to another portion of a subject, such as, for example, a wrist, an arm, a neck, a head, etc. For example, the sensing device 110 can be a watch or wristband that the user can press against the chest, with electrodes (e.g., dry electrodes) configured to sense one or more physiological signals. Handheld Sensing Devices

[0026] In some embodiments, the sensing device 110 can be configured to be a handheld device that a user can hold and / or press against the chest, e.g., to measure one or more physiological signal(s). The sensing of multiple cardiovascular signals from the chest can be accomplished with the handheld device. When the device is placed directly onto the subject’s chest, the device can be configured to record a plurality of signals from the user in parallel. In some embodiments, the device may be shaped in an ergonomic manner such that the user can hold the device in a still manner (e.g., with little or no movement present) in his or her hand while pressing the device against his or her chest.

[0027] The handheld device can include electrodes (e.g., dry electrodes), optical sensors (e.g., PPG sensors), and / or other types of sensors configured to sense one or more physiological signals. In some embodiments, the handheld device can have a unique shape and / or structure that is adapted to facilitate measurements of one or more physiological signal(s). For example, the handheld device can have one or more sensors that are disposed on an exterior of a housing, whereby the housing is shaped to be gripped or held by a user such that the one or more sensors are placed in engagement with skin of the user at predefined locations (e.g., along a palm or one or more fingers of the user, etc.). The handheld device can include shaped or angled surfaces, non-slip surfaces, cushioned surfaces, and / or other features that provide an ergonomic shape for a user to hold the handheld device. In some embodiments, the handheld device can be configured to have a shape or configuration that dictates a particular way of holding the handheld device, e.g., limits the handheld device to being held by a left hand vs. a right hand of a user, limits the handheld device to being held with at least two fingers including a thumb 6323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 of a user (e.g., a thumb and an index finger), etc. In some embodiments, the handheld device may include silicone or other high friction, elastomeric materials that allow for good adhesion to the surface of the skin on the chest while the handheld device is being held in place. In some embodiments, the handheld device may have a mass associated with it that is sufficiently high such that the device can hold firmly in place for the measurement, but low enough such that the user can easily lift and move the device into place. In some embodiments, the handheld device can be a user mobile device. For example, the sensing device 110 can be a phone, a phone case, card, tablet, cap, badge, etc., which can include sensors (e.g., dry electrodes, optical sensors, etc.) configured to sense one or more physiological signals.

[0028] FIG.9 provides a more detailed view of a handheld sensing device for capturing and / or analyzing physiological information of a user, according to an embodiment. The handheld sensing device 910 (e.g., structurally and / or functionally similar to the sensing device 110 and / or other sensing devices described herein) can include a processor 912, a memory 914, sensor(s) 916, an input / output (I / O) device 918, a communications interface 919, and / or optionally a vibration / acoustic signal generator 917. Optionally, the handheld sensing device 910 can communicate with other compute devices (e.g., via network(s) 102, short-range communication, and / or other wireless or wired communication paths).

[0029] The memory 914 can be and / or can include one or more of a random access memory (RAM), static RAM (SRAM), dynamic RAM (DRAM), a memory buffer, an erasable programmable read-only memory (EPROM), an electrically erasable read-only memory (EEPROM), a read-only memory (ROM), flash memory, volatile memory, non-volatile memory, combinations thereof, and the like. In some embodiments, the memory 914 can store instructions to cause the processor 912 to execute modules, processes, and / or functions associated with the handheld devices, such as those associated with processing and / or analyzing physiological signal(s) captured by the sensor(s) 916. In some embodiments, the memory 914 may also be configured to at least temporarily store data (e.g., identification information of a patient, historical health data, physiological data, etc.) until the data is transmitted to another device (e.g., compute device 140, 940; server 150; database(s) 160; etc.).

[0030] The processor 912 can be any suitable processing device(s) configured to run and / or execute a set of instructions or code. For example, the processor 912 can be and / or can include one or more data processors, image processors, graphics processing units (GPU), physics processing units, digital signal processors (DSP), analog signal processors, mixed-signal processors, machine learning processors, deep learning processors, finite state machines (FSM), compression processors (e.g., data compression to reduce data rate and / or memory 7323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 requirements), encryption processors (e.g., for secure wireless data and / or power transfer), and / or the like. The processor 912 can be, for example, a general-purpose processor, central processing unit (CPU), microprocessor, microcontroller, Field Programmable Gate Array (FPGA), an Application Specific Integrated Circuit (ASIC), a processor board, a virtual processor, and / or the like. The processor 912 can be configured to run and / or execute application processes and / or other modules, processes and / or functions associated with the handheld device. The underlying device technologies may be provided in a variety of component types, for example, metal-oxide semiconductor field-effect transistor (MOSFET) technologies like complementary metal-oxide semiconductor (CMOS), bipolar technologies like generative adversarial network (GAN), polymer technologies (e.g., silicon-conjugated polymer and metal-conjugated polymer-metal structures), mixed analog and digital, and / or the like. In some embodiments, the processor 912 can be configured to receive data from one or more sensor(s) 916 and to process that data, e.g., to extract features from the data, to determine a filling pressure or other cardiopulmonary parameter of a patient, etc. Alternatively or additionally, the processor 912 can be configured to send the data from the one or more sensors 916 to one or more remote devices (e.g., via a network 102) for further processing and / or analysis.

[0031] The communications interface 919 can include any suitable device(s) and / or interface(s) that can communicate with the compute device(s) 940, a network (e.g., a local area network (LAN), a wide area network (WAN), or the cloud), or any other external device (e.g., a user device such as cell phone, tablet, a laptop, or a desktop computer, etc.). Moreover, the communications interface 919 can include one or more wired and / or wireless interfaces, such as, for example, Ethernet interfaces, optical carrier (OC) interfaces, and / or asynchronous transfer mode (ATM) interfaces. In some embodiments, the communications interface 919 can be, for example, a network interface card and / or the like that can include at least an Ethernet port and / or a wireless radio (e.g., a WI-FI® radio, a BLUETOOTH® radio, cellular such as 3G, 4G, 5G, etc., 802.11X Zigbee, near-field communication, etc.). In some embodiments, the communications interface 919 can include one or more satellite, WI-FI, BLUETOOTH, near- field communication, or cellular antenna. In some embodiments, the communications interface 919 can be communicably coupled to an external device (e.g., an external processor) that includes one or more satellite, WI-FI, BLUETOOTH, near-field communication, or cellular antenna.

[0032] The I / O device(s) 918 may include any suitable device to receive input from a user or communicate an output to the patient or user. In some embodiments, the I / O device(s) 918 may 8323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 include an activation mechanism or otherwise, a user actuated element (e.g., a touch button, a push button, a switch, a touchpad, etc.) to turn on or otherwise activate the handheld sensing device 910, or to allow the user to enter information, request information, or set various parameters of the handheld sensing device 910 (e.g., sensor capture rate, light intensity, etc.). In some embodiments, the I / O device(s) 918 may include a visual indicator (e.g., LED lights, a display, etc.) to display information to the patient or the user. Such information may include, but is not limited to the patient’s physiological signal(s) or parameters such as PPG, SCG, patient blood oxygen, heart rate, blood pressure, temperature, etc., time of day, communications interface(s) status (e.g., connectivity status), power level, or any other suitable information or a combination thereof. In some embodiments, the I / O device 918 can be used to provide alerts to a user, e.g., to indicate to a user that there is too much movement for sensor data capture, to indicate to the user a possible issue with the sensor (e.g., sensor placement due to a wearable being worn too loosely, or sensor defect), etc. In some embodiments, the I / O device 918 can instruct a user to perform certain activities (e.g., to lay down or to minimize movement), e.g., to facilitate cleaner data capture by sensor(s) 916. In some embodiments, the I / O device 918 can display information received from the compute device 940. This information can include, for example, physiological information derived using a model or algorithm, as further described herein.

[0033] The sensor(s) 916 can include one or more sensor(s) configured to measure an observable or measurable characteristic of a user (e.g., ECG, PPG, SCG, electrodermal activity (EDA), blood pressure, heart rate, skin temperature, etc.). The sensor(s) 916 can send a signal indicative of the measured characteristic to the processor 912, memory 914, and / or other components of the sensing device 910. For example, the sensor(s) 916 can measure and output one or more of a SCG waveform, a PPG waveform, an ECG waveform, etc. In some embodiments, the data from the sensor(s) 916 is stored in the memory 914. In some embodiments, the processor 912 can be configured to control the operation of the sensor(s) 916. For example, the processor 912 can be configured to activate the sensor(s) 916 and / or change one or more operational parameters (e.g., light wavelengths, length intensity, sampling frequency, etc.) of the sensor(s) 916. The sensor(s) 916 can be configured to operate continuously, sporadically, and / or periodically.

[0034] In some embodiments, the sensor(s) 916 can include one or more electrodes placed on or against the body of the user. For example, the sensor(s) 916 can include one or more electrodes that can be placed on or against the body of the user. For example, the one or more electrodes can be stuck to the skin of the user. In some embodiments, the one or more electrodes 9323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 being stuck to the skin of the user can further affix the sensing device 110 to the user. Alternatively, or additionally, the sensor(s) 916 can include dry electrodes that can be placed against skin of the user. In some embodiments, the sensor(s) 116 can include one or more sensors configured to measure environmental parameters. For example, the sensor(s) 116 can be configured to measure one or more of temperature, humidity, altitude, and the like, or any combination thereof. In some embodiments, the sensor(s) 116 can be configured to measure a PPG signal of the user. The sensor(s) 116 can be configured to measure cardiogenic vibrations of the user. For example, the sensor(s) 116 can be configured to measure a SCG signal of the user. The sensor(s) 116 can be configured to measure tri-axial SCG signals. For example, tri- axial SCG signals can include the DV, Lat, and / or HtoF axis. In some embodiments, the sensor(s) 116 can be configured to measure a gyrocardiogram signal of the user.

[0035] As noted above, the handheld sensing device 910 can optionally communicate with one or more compute device(s) 940. The compute device(s) 940 can be configured to process and / or analyze sensor data, e.g., received from the sensing device 910, and / or other data, e.g., received from a user, a database, or other source (e.g., such as other devices depicted in FIG. 1). For example, the compute device 940 can be configured to filter, rectify, differentiate, integrate, enhance, pre-process, and / or combine the sensor data. In some embodiments, the compute device 940 can be configured to receive sensor data from more than one sensing device (e.g., handheld sensing 910, an implanted sensing device, or other sensing devices). In some embodiments, the compute device 940 can be nearby the sensing device 910, such as, for example, a local computer, laptop, mobile device, tablet, etc. In some embodiments, the compute device 940 can be a server that is remote from the sensing device 910 but can communicate with the sensing device 910, e.g., via a network (as depicted in FIG. 1). In some embodiments, the sensing device 910 can be configured to transmit sensor data to a nearby device (e.g., a user device such as a mobile device) via a wireless network (e.g., Wi-Fi, Bluetooth, etc.), and then that device can be configured to transmit the sensor data to the compute device 940 for further processing and / or analysis. In some embodiments, the compute device 940 is implemented as or includes a user device.

[0036] The compute device 940 can include a processor 922, a memory 924, an I / O device 928, and a communications interface 929 (or a multiplicity of such components). The memory 924 can be, for example, a random access memory (RAM), a memory buffer, a hard drive, a flash memory, a database, an erasable programmable read-only memory (EPROM), an electrically erasable read-only memory (EEPROM), a read-only memory (ROM), and / or so forth. In some embodiments, the memory 924 stores instructions that cause processor 922 to 10323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 execute modules, processes, and / or functions associated with processing and / or analyzing sensor data from sensing device 910. In some instances, the memory 924 can be operatively coupled to other compute devices (e.g., as depicted in FIG. 1). In some embodiments, the memory 924 stores information associated with more than one user. For example, compute device 940 can be a household account, a medical provider account, and / or the like, and the memory 924 can be configured to store information associated with one or more users associated with that account. The administrator account can be utilized to allow one or more users (e.g., healthcare professionals, caretakers, etc.) to access information during operation.

[0037] The processor 922 of compute device 940 can be any suitable processing device configured to run and / or execute functions associated with processing and / or analyzing sensor data from the sensing device 910. The processor 922 can be a general purpose processor, microcontroller, a Field Programmable Gate Array (FPGA), an Application Specific Integrated Circuit (ASIC), a Digital Signal Processor (DSP), and / or the like. In some embodiments where the sensing device 910 and the compute device 940 are implemented as one device, the processor 922 and the processor 912 can be the same processor.

[0038] In some embodiments, the compute device 940 can be configured to process a signal from the sensor(s) 916 and / or other sensed information, e.g., to determine physiological information (e.g., cardiopulmonary-related parameter(s) of the patient and / or a predictive clinical status of a heart disease or condition). The sensed information can include, for example, one or more of raw sensor signal information, processed sensor signal information, timestamp information, time window information, contextual information, and / or the like. In some embodiments, the sensed information can indicate a time period during which the sensed information was obtained and / or collected. In some embodiments, the compute device 940 can be configured to send instructions to the sensing device 910 to cause the sensing device 910 to operate according to one or more parameters. For example, the processor 922 can be configured to send instructions to the sensing device 910 to take measurements at predetermined times and / or intervals.

[0039] FIG. 2 provides an example of a handheld device 210 being held against a chest of a subject at a target location 212, according to embodiments. The handheld device 210 is structurally and / or functionally similar to other sensing devices described herein, including, for example, the sensing device 110 and / or the handheld sensing device 910. In some embodiments, the handheld device 210 can be a phone, a phone case, card, tablet, cap, badge, etc. As depicted, the sensing device 210 can be held by one or more hands of the subject (or other user), and placed at a predefined position or orientation near the target location 212, e.g., 11323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 to capture one or more physiological signal(s) of the subject. In some embodiments, the user can be laying supine when positioning the device against the target location 212. In some embodiments, the target location 212 can be proximate to (e.g., immediately below) the suprasternal notch of the subject.

[0040] FIG.5 provides another example of a handheld device 510, according to embodiments. Similar to the handheld device 210, the handheld device 510 can be held against a chest of a subject at a target location (e.g., target location 212). The handheld device 510 can be structurally and / or functionally similar to other sensing devices or handheld devices described herein (e.g., sensing device 110, handheld device 210, etc.). For example, the handheld device 510 can include an ergonomic housing 502 and multiple sensors 516a, 516b, 516c, 516d. The ergonomic housing 502 can include shaped or angled surfaces, non-slip surfaces, cushioned surfaces, and / or other features that provide an ergonomic shape for a user to hold the handheld device. For example, the device 510 may include silicone or other soft materials that allow for temporary adhesion or grip to the surface of the skin on the chest while it is being held in place, and may have a predetermined mass that enables the device to be held firmly in place for measuring one or more physiological signals while allowing the device to be lifted by a user to move the device into place. In some embodiments, the device may have a mass between about 0.5 lbs and about 3 lbs, inclusive of all values and sub-ranges therebetween.

[0041] As depicted, the ergonomic housing 502 of the handheld device 510 can have a shape that dictates a predefined way of holding the handheld device 510. For example, the housing 502 can have a base region 502a (e.g., with a dome-like shape) with an extension or protrusion 502b that can form a grip for a user to grip the device using at least two fingers. The protrusion 502b can be shaped or angled such that a user is inclined to grip the device with his left hand (however, one can appreciate that a handheld device can be designed with the protrusion 502b angled in an opposite direction to facilitate gripping using the right hand). For example, the protrusion 502b can be angled toward the thumb and / or have a curved or concave surface that is configured to receive the thumb of the left hand of the user. When the handheld device 510 is gripped or held by the user in the predefined way, the sensor(s) of the device 510 desirably contact one or more regions of the user, e.g., to measure one or more physiological signal(s) of the user, as described below.

[0042] The sensors can include a first sensor 516a that is an electrode (e.g., a dry electrode) that is configured to contact skin of a palm of the user when the user grips the handheld device 510. The sensor 516a can be disposed on an exterior surface (or have a region that is exposed on an exterior surface) of the device 510. The sensor 516a can be an ECG electrode that is 12323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 configured to facilitate measurement of an ECG signal. As described above, the housing 502 of the sensing device 510 can be designed to be gripped by a left hand of a user. As such, the sensor 516a can be configured to act as a left arm or left hand lead for measuring an ECG signal. Alternatively, the housing 502 can be designed to be gripped by a left hand of a user, and the sensor 516a can be configured to act as a left arm or left hand lead for measuring an ECG signal.

[0043] The sensors can include a second sensor 516b that is a PPG sensor. The PPG sensor can be configured to contact skin of a finger of the user (e.g., skin at the fingertip) when the user grips the handheld device 510. The sensor 516b can be disposed on an exterior surface (or have be exposed on an exterior surface) of the device 510. The sensor 516b can include an optical sensor module, including one or more light emitting diodes (LEDs) and one or more photodiodes (PDs) that contact the hand holding the device, such that the PPG signal can be measured from the hand that holds the device in place. In some embodiments, in the region of the PPG sensor, there can be a visual indicator (e.g., a visual marking, light, etc.) that can inform a user of where to place the finger of the user. For example, the region of the PPG sensor can include a marking that the user is instructed to cover with his or her index finger. In some embodiments, the region of the PPG sensor can include an indentation, a dip, surface texture, or other structure that can provide haptic feedback to a user to guide the user to place his or her finder in the appropriate location. For example, the region of the PPG sensor can include one or more bumps or ridges that guide a user’s finger into engagement with the PPG sensor. In some embodiments, either in tandem with the sensor 516b, or in place of sensor 516b, the device can also include an optical sensor module positioned on the surface that contacts the chest of the user when the device is placed against the chest of the user. This optical sensor module can be configured to measure the PPG signal from the blood vessels on the chest of the subject. The PPG signal measured from the blood vessels on the chest of the subject can provide complementary or redundant (e.g., for noise rejection purposes) information to the PPG derived from the finger. Therefore, in some embodiments, both the chest and the finger PPG signal can be measured together with the same device.

[0044] The sensors can include a third sensor 516c that is an accelerometer (e.g., a tri-axial accelerometer). The accelerometer can be disposed within an interior of the housing 502. The accelerometer can be configured to measure tri-axial SCG signals. For example, tri-axial SCG signals can include the DV, Lat, and / or HtoF axis. In an embodiment, the accelerometer can be a micro-electro-mechanical system (MEMS) accelerometer. The accelerometer can have sufficiently low noise and / or high sensitivity (e.g., spot noise less than about 30 μg / sqrt(Hz), 13323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 inclusive of any values and sub-ranges therein) such that the SCG signal can be detected from the chest of the user. When the accelerometer is a tri-axial accelerometer, the accelerometer can simultaneously record three axes of SCG signals. The accelerometer can have sufficiently low noise and wide bandwidth (e.g., greater than about 1000 Hz) such that the accelerometer is configured to detect heart sounds. For example, the user can be instructed, such as with an application on a smartphone, tablet, laptop, or other user device to move the handheld device around to different locations on the chest for purposes of detecting heart sound information (e.g., auscultation). For SCG measurements, the handheld device may need to be positioned against the chest at a location proximate to the sternum. For auscultation measurements, the handheld device may need to be positioned closer to the heart and between the ribs of the user. In these locations, auscultation information regarding potential murmurs, S3 or third heart sounds, etc. can be detected. In some embodiments, the handheld device 510 can include multiple accelerometers, e.g., accelerometers configured to measure SCG signals and / or accelerometers configured to measure auscultation signals. In such embodiments, when the handheld device 510 is positioned on the chest in its predefined location, the accelerometer for measuring SCG can be positioned proximate to the sternum while the accelerometers for measuring auscultation signals can be positioned clear to the heart and / or between ribs of the user. The SCG measurements and / or auscultation sounds can be processed and / or analyzed, e.g., to assess a heart health of a user or determine a predictive clinical status of heart disease (e.g., heart failure).

[0045] The sensors can include a fourth sensor 516d that is configured to contact skin of a chest of the user when the user places the handheld device 510 against the chest (e.g., at the target location). The sensor 516d can be disposed on an exterior surface (or have a region that is exposed on an exterior surface) of the device 510. The sensor 516d can be an ECG electrode that is configured to facilitate measurement of an ECG signal. In some embodiments, the sensor 516d can be a stainless steel “dry” electrode or an electrode with a hydrogel configured to allow lower skin-electrode resistance when placed on the chest. The sensor 516d, together with the sensor 516a that is configured to contact the hand of the user, can measure an ECG signal across the heart of the user.

[0046] While the handheld device 510 is described with reference to four sensors (516a, 516b, 516c, 516d), it can be appreciated that the device can include less than four sensors or more than four sensors. For example, in some embodiments, the handheld device 510 may not include a PPG sensor, one or more ECG sensors, or a SCG sensor. In some embodiments, the handheld device 510 can include additional sensors, such as, for example, a temperature sensor 14323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 (e.g., a contact temperature sensor such as a surface thermocouple, or infrared temperature sensor), an impedance sensor (e.g., one or more electrodes for sensing tissue surface impedance and / or conductance, or impedance across a region of the body), a force sensor, etc. In such embodiments, these sensors can be placed at desirable locations for capturing physiological signal(s) of the user. For example, sensors that require contact with the user’s skin can be placed at locations where there would be contact between the device and skin. In some embodiments, the handheld device 510 includes one or more contact force measurement sensor(s) on the surface configured to contact the chest, e.g., to measure forces, which can be used to ensure sufficient contact has been made against the chest for the measurements of one or more physiological signals to initiate. Alternatively, or additionally, the contact between the handheld device and the chest of the user can be constantly monitored, and the signals measured by the sensors of the handheld device can be discarded during period(s) whether there is not sufficient contact between the handheld device and the chest of the user. In some embodiments, the handheld device 510 can include one or more output devices, such as one or more of a haptic, light, and / or sound output device that can provide feedback to the user, e.g., to indicate to the user when the device has been engaged properly and / or improperly with the skin of the user, to indicate to the user when the device is in the right orientation and / or the user is in the right posture or orientation for capturing physiological signals, and / or to provide other feedback to the user. In some embodiments, the handheld device 510 includes four or more electrodes, two contacting the chest and two contacting the hand, e.g., to measure bioimpedance, such as for measuring the fluid levels in the chest cavity and / or measuring the changes in impedance of the chest associated with the heartbeat (e.g., impedance cardiography / plethysmography) or with respiration (e.g., impedance pneumography). In some embodiments, the handheld device 510 can include a signal generator configured to generate and provide an acoustic or vibration input to the body, such that active auscultation (e.g., percussion) based assessments can be made of fluid, as well as biomechanical properties of the skin and musculoskeletal system. Implanted Sensing Devices

[0047] In some embodiments, the sensing device 110 can include a subcutaneously implanted device. For example, the sensing device 110 can be a loop device or loop recorder, which can include sensing hardware configured to capture or acquire one or more physiological signals from a subject. For example, the implanted sensing device 110 can include a housing that supports one or more electrodes or other sensors configured to measure one or more physiological signals (e.g., ECG, SCG, and / or PPG). The sensing device 110 can be implanted 15323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 near a heart of a patient, e.g., for measuring information such as ECG, SCG, and / or blood volume pulse signals. In some embodiments, the sensing device 110 can be implanted and positioned in the subcutaneous space at the sternum. In some embodiments the sensing device 110 can be implanted and positioned near the clavicle. In some embodiments, the sensing device 110 can be attached or coupled to specific patient anatomy via adhesive backed electrodes and / or the like.

[0048] FIG. 3 depicts various locations of where a sensing device 110 can be implanted. For example, the first position 310a corresponds to a position near the clavicle, a second position 310b corresponds to a position under the pectoral, and a third position 310c corresponds to a position under the sternum. In some embodiments, the sensing device 110 can be implanted in a different location than shown in FIG. 3. Secondary Devices

[0049] In some embodiments, the sensing device 110 can optionally be used with a secondary device 120. The sensing device 110 can be operatively coupled to the secondary device 120, e.g., via near-field communication, a wireless connection (e.g., Wi-Fi, Bluetooth, etc.), magnetic coupling, and / or a wired connection. In some embodiments, the sensing device 110 can be operatively coupled to the network(s) 102, and through the network(s) 102, be coupled to the secondary device 120, the compute devices140,the server 150, the database(s) 160, and / or other device(s) 190. The sensing device 110 can be operatively coupled to such devices such that the sensing device 110 can send information (e.g., sensor signals) to and / or receive information (e.g., instructions for monitoring a patient or subject, parameters for operation, etc.) from one or more such devices. In some embodiments, a synchronization trigger may be used to achieve precise (e.g., sub-millisecond) temporal synchronization between the clocks of the implanted sensing device 110 and the secondary external sensing device 120.

[0050] In some embodiments, the sensing device 110 can be an implanted or implantable device, as described above, and it can be used together with a secondary device 120 to measure one or more physiological signals of a subject. The secondary device 120 can be a second implanted device or an external device. For example, the secondary device 120 can be an external device that a user can press against his or her skin from outside (e.g., a wearable device such as a watch, or a phone, phone case, or other handheld or standalone device). In some embodiments, the secondary device 120 can be a sensing device, such as a wearable sensing device and / or a handheld sensing device (e.g., handheld device 210, 510), as described above. The secondary device 120 can be configured to read information measured or acquired by the implanted device, and to combine the information that can be sensed by the implanted device 16323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 together with information sensed by the secondary device 120 and / or other sensing devices. Communication between the implanted device and the external device can occur continuously throughout use and / or sporadically at time points that are determined to be advantageous. For example, the time points can be configured such that overall power consumption is reduced. Communication can occur when the patient is still, for example, as determined by accelerometer or inertial measurement unit signals measured either with the implantable device or the external device or both. Other Devices

[0051] The sensing device 110 and / or the secondary device 120 can be operatively coupled to one or more other compute devices, including, for example, a compute device 140, a server 150, a database 160, and / or optionally, one or more other device(s) 190, via one or more network(s) 102. The network 102 can be any type of network implemented as a wired network and / or wireless network and used to operatively couple the sensing device 110, the secondary device 120, the compute device 140, the server 150, the database 160, and / or other device(s) 190 to one another. The communication may or may not be encrypted. A wireless network may refer to any type of digital network that is not connected by cables of any kind. Examples of wireless communication in a wireless network include, but are not limited to cellular, near- field communication, radio, satellite, and microwave communication. However, a wireless network may connect to a wired network in order to interface with the Internet, other carrier voice and data networks, business networks, and personal networks. A wired network is typically carried over copper twisted pair, coaxial cable and / or fiber optic cables. There are many different types of wired networks including wide area networks (WAN), metropolitan area networks (MAN), local area networks (LAN), Internet area networks (IAN), campus area networks (CAN), global area networks (GAN), like the Internet, and virtual private networks (VPN).

[0052] The server 150 can be any device configured to process signals and / or data received from the sensing device 110, the secondary device 120, the compute device 140, and / or other devices connected to network 102. The database 160 can be any device configured to store data, e.g., received from other devices. For example, the database 160 can include instructions for storing signal data (e.g., signals captured by sensor(s) of the sensing device 110 and / or secondary device 120), processed signal data, signal repositories, and / or the like. In some embodiments, the database 160 can store the final outputs from processing the signals, such as, for example, clinically relevant physiological data waveforms and / or health information (e.g., heart health information). In some embodiments, the database 160 can be configured to store 17323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 other patient information, e.g., historical physiological characteristic information, patient demographic information, patient health history, etc. The device(s) 190 can include, for example, additional sensing device(s) (e.g., functionally and / or structurally similar to the sensing device 110) and / or additional compute device(s) (e.g., including a processor, memory, input / output devices, etc.). In some embodiments, the other device(s) 190 can include compute devices that are associated with one or more third parties, such as, for example, an administrator, a physician or healthcare provider, a hospital, a caretaker, etc. Systems including Implanted and External Devices

[0053] As described above, in some embodiments, systems described herein can include a sensing device such as an implantable sensing device and one or more external devices. In such embodiments, the sensing device and the external device can operate together to provide information regarding a user or subject.

[0054] FIG. 8 provides a detailed view of an implantable sensing device 810 configured to operate with an external device 820, according to embodiments. The implantable sensing device 810 (e.g., structurally and / or functionally similar to the sensing device 110 and / or other sensing devices described herein) can include a processor 812, a memory 814, sensor(s) 816, an input / output (I / O) device 818, and a communications interface 819. The implantable sensing device 810 can be operatively couplable to the external device 820, which can be structurally and / or functionally similar to other external devices described herein (e.g., secondary device 120). In some embodiments, the external device 820 can also function as a sensing device, and therefore can include components that are structurally and / or functionally similar to other sensing devices described herein (e.g., sensing device 110, 210, 510, etc.). The external device 820 can include a processor 822, a memory 824, and a communications interface 819, and optionally can include one or more sensor(s) 826, an input / output (I / O) device 818, and / or a vibration / acoustic signal generator 817.

[0055] The memory 814 of the implantable sensing device 810 and / or the memory 824 of the external device 820 can be structurally and / or functionally similar to other memories or memory devices described herein. For example, the memory 814 of the implantable sensing device 810 and / or the memory 824 of the external device 820 can be and / or can include one or more of a random access memory (RAM), static RAM (SRAM), dynamic RAM (DRAM), a memory buffer, an erasable programmable read-only memory (EPROM), an electrically erasable read-only memory (EEPROM), a read-only memory (ROM), flash memory, volatile memory, non-volatile memory, combinations thereof, and the like. In some embodiments, the memory 814 onboard the implantable sensing device 810 can be smaller than the memory 824 18323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 of the external device 820, e.g., due to size constraints and / or to balance power efficiency with the implantable device. Therefore, the memory 814 may store more limited information than the memory 824, including, for example, code or instructions for operation of the implantable sensing device 810, more critical patient information, and / or physiological signal(s) measured by the implantable sensing device 810 within recent windows of time. In some embodiments, the memory 814 may be configured to at least temporarily store data (e.g., physiological data measured by one or more onboard sensor(s)) until the data is transmitted to another device (e.g., external device 820, compute device 840, and / or other devices such as those described in FIG. 1). The memory 824 of the external device 820 can be configured to store code or instructions for operation of the external device 820, patient information, and / or physiological signal(s) measured by the implantable sensing device 810 (and transmitted to the external device 820) and / or sensor(s) onboard the external device 820.

[0056] The processor 812 of the implantable device 810 and / or the processor 822 of the external device 820 can be structurally and / or functionally similar to other processors described herein. For example, the processor 812 of the implantable device 810 and / or the processor 822 of the external device 820 can be any suitable processing device(s) configured to run and / or execute a set of instructions or code. For example, the processor 812 and / or the processor 822 can be, for example, a general-purpose processor, central processing unit (CPU), microprocessor, microcontroller, Field Programmable Gate Array (FPGA), an Application Specific Integrated Circuit (ASIC), a processor board, a virtual processor, and / or the like. In some embodiments, the processor 812 and / or the processor 822 can be configured to receive data from one or more sensor(s) 816 and / or 826 and to process that data, e.g., to extract features from the data, to determine a filling pressure or other cardiopulmonary parameter of a patient, etc. Alternatively or additionally, the processor 812 and / or the processor 822 can be configured to send the data from the one or more sensors 816 and / or 826 to one or more remote devices (e.g., via a network 102) for further processing and / or analysis.

[0057] The communications interface 819 of the implantable device 810 and / or the communications interface 829 of the external device 820 can be structurally and / or functionally similar to other communications interfaces described herein. For example, the communications interface 819 can include any suitable device(s) and / or interface(s) that can communicate with the external device 820 and / or compute device(s) 840. In some embodiments, the communications interface 819 can be configured to communicate via short-range communication (e.g., WI-FI®, Zigbee, near field communication, etc.) with the external device 820. The communications interface 819 can be configured to send information (e.g., 19323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 physiological signal(s), detected events, error codes, etc.) to the external device 820, which can be configured to further analyze such information. The communications interface 819 can also be configured to receive information (e.g., instructions to change operation of its sensor(s)) from the external device 820. The communications interface 829 of the external device 820 can communicate with the implantable sensing device 810 and / or compute device(s) 840 (or other compute devices, such as those described with respect to FIG. 1). The communications interface 829 can be configured to receive information from the implantable device 810 and to further process and / or analyze such information. In some embodiments, the external device 820, via communications interface 829, can be configured to send information to the implantable device, e.g., to change one or more operating parameters of the implantable device. For example, if one or more sensor(s) of the external device 820 and / or other devices detect that the implantable device 810 has shifted (e.g., moved in location and / or orientation), then the external device 820 may be configured to send information to the implantable device 810 to adjust its operation based on the shift in position or orientation. In some embodiments, the implantable device 810 may include multiple sensors, and upon detection of a shift in position or orientation, or upon detection of an error in the measurements collected by one or more sensors, the external device 820 may send information to the implantable device 810 to deactivate one or more sensors (e.g., faulty sensors, or sensors capturing erroneous or noisy data) and / or activate other sensors (e.g., to capture the physiological signal(s) in a different location and / or for providing validation or redundancy in data). While not depicted, in some embodiments, systems described herein can also include more than one implantable sensing device 810. In such embodiments, each implantable sensing device 810 can send information (e.g., physiological signal(s)) to the external device 820. In some embodiments, the external device 820 can be configured to send signals to the implantable sensing devices 810 to adjust their operation, e.g., to shut off or activate one or more implantable sensing device 810, to have them collect measurements at different times and / or when the patient is in different postures, etc.

[0058] The I / O device(s) 828 may include any suitable device to receive input from a user or communicate an output to the patient or user. In some embodiments, the I / O device(s) 828 may include an activation mechanism or otherwise, a user actuated element (e.g., a touch button, a push button, a switch, a touchpad, etc.) to turn on or otherwise activate the external device 820 and / or implantable sensing device 810 (e.g., via the communications interfaces between the two devices), or to allow the user to enter information, request information, or set various parameters of the external device 820 and / or the implantable sensing device 810 (e.g., sensor 20323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 capture rate, light intensity, etc.). In some embodiments, the I / O device(s) 828 may include a visual indicator (e.g., LED lights, a display, etc.) to display information to the patient or the user. Such information may include, but is not limited to the patient’s physiological signal(s) or parameters such as PPG, SCG, patient blood oxygen, heart rate, blood pressure, temperature, etc., time of day, communications interface(s) status (e.g., connectivity status), power level, or any other suitable information or a combination thereof. In some embodiments, the I / O device 828 can be used to provide alerts to a user, e.g., to indicate to a user that there is too much movement for sensor data capture, to indicate to the user a possible issue with the sensor (e.g., sensor placement being in wrong location, sensor having an error), etc. In some embodiments, the I / O device 828 can instruct a user to perform certain activities (e.g., to lay down or to minimize movement), e.g., to facilitate cleaner data capture by sensor(s) 816 and / or 826. In some embodiments, the I / O device 828 can display information received from the compute device 840. This information can include, for example, physiological information derived using a model or algorithm, as further described herein.

[0059] The sensor(s) 816 can be configured to measure physiological signal(s) of a user, such as, for example ECG signal(s), SCG signal(s), impedance data, biochemical sensing (e.g., level of biomarkers), auscultation signals (e.g., of heart sounds), etc. In some embodiments, the sensor(s) 816 can be selected to measure signals that are more easily captured from an implanted location within the body (e.g., a subcutaneous, endoluminal, or otherwise implanted location). In some embodiments, the sensor(s) 816 can be designed to be biocompatible, e.g., for implantation into a user. In some embodiments, the external device 820 can optionally include one or more sensor(s) 826. For example, as described with reference to FIG. 9, a handheld sensing device can include one or more sensor(s) 916. The sensor(s) 826 can be structurally and / or functionally similar to the sensor(s) 916 and / or other sensors described herein that are disposed on or in external devices.

[0060] The implantable sensing device 810 and / or external device 820 can optionally communicate with one or more compute device(s) 840. The compute device(s) 840 can be structurally and / or functionally similar to other compute devices described herein, including, for example, compute device 140, 940, etc. For example, the compute device(s) 840 can be configured to process and / or analyze sensor data, e.g., received from the implantable sensing device 810, the external device 820, and / or other data, e.g., received from a user, a database, or other source (e.g., such as other devices depicted in FIG.1). The compute device(s) 840 can include a processor 842 (e.g., structurally and / or functionally similar to other processors described herein), a memory 844 (e.g., structurally and / or functionally similar to other 21323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 memories described herein), an I / O device 848 (e.g., structurally and / or functionally similar to other I / O devices described herein, and a communications interface (e.g., structurally and / or functionally similar to other communications interfaces described herein). In some embodiments, the compute device 840 can be nearby the implantable sensing device 810 and / or external device 820, such as, for example, a local computer, laptop, mobile device, tablet, etc. In some embodiments, the compute device 840 can be a server that is remote from the implantable sensing device 810 and / or external device 820 but can communicate with the implantable sensing device 810 and / or external device 820, e.g., via a network (as depicted in FIG. 1).

[0061] In an example embodiment, the implanted device (e.g., sensing device 110, implantable sensing device 810) includes ECG measurement functionality (e.g., similar to a loop recorder), and the external device (e.g., secondary device 120, external device 820) can include an accelerometer (e.g., with low noise and high sensitivity) to acquire SCG signals and / or a light source (e.g., LED) and sensor (e.g., photodiode) to acquire a PPG signal. The externally detected signals can be synchronized with the internally recorded ECG such that the three signals can be accurately and synchronously recorded by the combination of the implantable device and the external device.

[0062] In another example embodiment, the implantable device (e.g., sensing device 110, implantable sensing device 810) can have ECG measurement functionality (e.g., similar to a loop recorder), and also include an accelerometer (e.g., low noise accelerometer) on board to detect SCG signal(s). Optionally, an external device (e.g., secondary device 120, external device 820) can be used together with the implantable device, or the ECG and SCG measurement from the implantable device can be sufficient for providing information for assessing a health condition of the subject. If an external device is used, that device can be configured to measure a PPG signal. Optionally, the external device can also measure another SCG signal that can be used redundantly with the SCG measured with the implantable to reduce noise and / or correct for any distortion that occurs in the SCG signal acquired by the implantable device. This distortion can result from, for example, when the implanted device potentially moves over time under the skin, or when the implanted device becomes surrounded by scar tissue which can compromise the internally measured SCG signal quality. In some embodiments, the external device can be used to validate the data being captured or acquired by the implanted device. In some embodiments, the external device can be used to assess the data being captured or acquired by the implanted device. For example, the external device can capture data to determine whether the implanted device has migrated, and whether such 22323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 migration necessitates an adjustment to how the signals acquired by the implanted device should be processed and / or calibrated. Alternatively, or additionally, the external device can capture data to determine whether the implanted device information has been compromised, and therefore the implanted device may need to be readjusted (e.g., repositioned and / or reattached to patient anatomy), replaced, etc.

[0063] In some embodiments, the implantable device (e.g., sensing device 110, implantable sensing device 810) can include biochemical sensing capability, for example, to detect biomarkers in the interstitial fluid representative of health status. For example, tumor necrosis factor (TNF) alpha levels may be recorded by the implantable device to quantify levels of inflammation, and these can be combined with the physiological data obtained from the implantable device (e.g., including ECG and / or SCG data) and / or combined with data obtained from an external device (e.g., including or for ECG, SCG, and / or PPG data capture). Since chronic and acute stress can impact physiological measurements, such as by increasing heart rate, reducing the pre-ejection period (PEP), reducing pulse transit time (PTT), and modulating other physiological signal markers that can be relevant for estimating filling pressures, the ability to quantify the level of chronic and acute stress using a complementary stream of data, such as, e.g., TNF-alpha, could allow for better contextualization of the physiological parameters and thus more accurate assessment of filling pressures in a wide variety of physiological states. For example, if a person’s TNF-alpha is elevated compared to their baseline value, the physiological state of the person may be assumed to be stressed or otherwise inflamed, and thus the physiological data may not be trusted at that point for the filling pressure output delivered. Additionally, the combination of biochemical markers of inflammation and physiological signals can improve the accuracy of filling pressure estimation, and can be used in tandem to provide improved health status determinations to clinicians and / or the patient, e.g., to guide treatments and / or therapy. Since autonomic adaptation is a common occurrence in the hemodynamic congestion pathway that a patient with heart failure experiences following initial hemodynamic congestion, it is expected that increased sympathetic output associated with such adaptation may lead to changes in blood biomarkers such as TNF-alpha, interleukin- 6 (IL-6), brain natriuretic peptide (BNP), and others, and thus the combination of such information together with physiological data measured through the ECG, SCG, and PPG may lead to more accurate estimates of filling pressures and even prediction of impending heart failure hospitalization events.

[0064] In some embodiments, the external device (e.g., secondary device 120, external device 820) may have a vibration actuator (e.g., a transducer) on the device that can send vibration 23323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 signals through the skin to ensure that the implantable sensing device configured for SCG measurement is properly functioning and / or has not degraded in its signal quality. Vibration signals can be generated, for example, by linear resonant actuators (LRAs) at frequencies ranging from about 100 to about 500 Hz (inclusive of all values and sub-ranges therebetween) and these signals when inputted at the sternum can then lead to the vibration of the implanted device in the subcutaneous space. Other methods of generating vibration signals could include piezoelectric actuators on the skin. The vibration patterns can include swept sine where a range of frequencies pertinent to SCG measurement (e.g., including infrasonic frequencies) could be inputted all the way up to frequencies corresponding to valve closure events. The patterns could also include impulse trains such that broadband excitation could be achieved, and / or more complex patterns such as bursts. The vibrations would be generated when the external device is placed up against the user’s skin periodically (e.g., once per day or once per week) such that any changes in the mechanical mounting of the implanted sensor within the chest are detected as early as possible to either reduce the confidence in the measured signals or to correct for the changes via understanding the mechanical frequency response of the overall system. These vibrations may also allow for a determination of whether the implantable device is rigidly secured to the body to be able to accurately detect cardiogenic vibrations (e.g., via SCG) without excessive damping or other distortion which can affect signal quality. In some embodiments, the vibrations can be used to calibrate signals acquired by the implanted device, such as, for example, SCG signals.

[0065] In some embodiments, the implantable device may be positioned in an auscultation site where heart sounds can be reliably recorded, and may provide feedback via communication to the external device to help the user properly position the external device over the implantable device, e.g., for recording of heart sounds via a contact microphone or other sensor on the external device.

[0066] FIG.4 depicts an example of an implanted device used together with an external device, according to embodiments. The implanted device can be structurally and / or functionally similar to other sensing devices or implantable devices described herein (e.g., sensing device 110, implantable device 810). The external device can be structurally and / or functionally similar to other external devices described herein (e.g., secondary device 120, external device 820, handheld sensing device 910). In some embodiments, both the implanted device and the external device can be examples of sensing devices, as each can include one or more sensor(s), as described herein. The external device 420 is configured to engage the patient on the outside of the body and the implanted sensing device 410 is implanted within the body. The implanted 24323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 sensing device 410 is communicably coupled to the external device 420 via a network 402 (e.g., structurally and / or functionally similar to the network 102). The implanted sensing device 410 includes electrodes 416a configured to measure ECG and an accelerometer 416b configured to measure SCG. The external device 420 includes a LED 426a, an accelerometer 426b, and a photodiode 426c. The LED 426a and the photodiode 426c are configured to measure PPG and the accelerometer 426b is configured to measure SCG. In embodiments, the accelerometer 426b and the accelerometer 416b can be used separately on together when measuring SCG. As described above, the accelerometer 426b of the external device can be used redundantly with the SCG measured with the implantable device to reduce noise and / or correct for any distortion that occurs in the SCG signal acquired by the implantable device. This distortion can result from, for example, when the implanted device potentially moves over time under the skin, or when the implanted device becomes surrounded by scar tissue which can compromise the internally measured SCG signal quality. In some embodiments, the signals from the two accelerometers 416b, 426b can be combined into a resulting signal (e.g., a third signal) that is used as the SCG signal in further processing / analysis. In some embodiments, the signal from one of the two accelerometers 416b, 426b can be kept for further processing / analysis, while the other is discarded. Methods

[0067] Systems and devices described herein can implement one or more methods for measuring and / or analyzing physiological information of a subject.

[0068] FIG.6 is a flow chart illustrating a method 600 for capturing and / or determining one or more physiological parameter(s) and / or cardiopulmonary-related parameter(s) of a patient, according to embodiments. The method can be executed by any of the systems and devices described herein, for example, the handheld devices described with respect to FIGS. 1, 2, 5, and 9.

[0069] At 602, the method 600 includes assessing sensor contact between a handheld sensing device (e.g., handheld device 910) and a target region of a patient or user (e.g., a chest of the user). As described above, the handheld sensing device can include one or more sensors (e.g., contact force sensors, electrodes, etc.), which can be configured to measure a force, impedance, or other parameter when the device is placed into contact with a skin surface of the user. The one or more sensors can capture sensor data that indicates whether the handheld device has been properly positioned against the skin surface of the user. The processor of the handheld device (e.g., processor 912) can analyze the sensor data to assess the contact between the handheld device and the target region of the patient. For example, one or more force sensors 25323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 can be configured to measure the force between the surface of the handheld device configured to engage the chest of the user and the chest of the user, when the user has positioned the handheld device against the chest of the user. If the engagement or contact between the handheld device and the skin of the user is not sufficient (e.g., the measured forces is less than a predetermined level, or outside a predetermined range), then the device may output an alert (or communication with a user device to output an alert) to inform the user that the contact is not sufficient so that the user adjusts the positioning of the device. If the engagement or contact between the handheld device and the skin of the user is sufficient (e.g., the measured forces is equal to or greater than a predetermined level, or within a predetermined range), then the device may output an indication (e.g., visual, audio, haptic) to inform the user that the contact is sufficient. In some embodiments, the handheld device can include additional sensor(s) that detect whether a user’s finger and / or palm is in engagement with one or more portions of the handheld device (e.g., for capturing measurements from the user). In some embodiments, the handheld device may also communicate with an external device such as a user device to have the user device provide instructions to the user to properly place the device against the chest of the user and / or properly grip the handheld device.

[0070] In some embodiments, depending on whether the contact between the handheld device and the skin of the user is sufficient (e.g., whether the measured forces is equal to or greater than a predetermined level, or within a predetermined range), the handheld device may or may not initiate measurement of one or more physiological parameters of the patient, at 608. For example, the handheld device may monitor to determine when the contact between the handheld device and the skin of the user is sufficient before initiating measurement of one or more physiological parameters of the patient. In some embodiments, the handheld device may monitor the contact between the handheld device and the skin of the user and discard any sensor measurements of the physiological parameters during periods where the contact between the handheld device and the skin of the user is insufficient. In some embodiments, depending on whether the contact between a finger or a palm of the user and one or more portions of the handheld device is sufficient (e.g., whether the measured forces is equal to or greater than a predetermined level, or within a predetermined range), the handheld device may or may not initiate measurement of one or more physiological parameters of the patient, at 608. For example, the handheld device may monitor to determine when the contact between a finger or a palm of the user and one or more portions of the handheld device is sufficient before initiating measurement of one or more physiological parameters of the patient. In some embodiments, the handheld device may monitor the contact between a finger or a palm of the user and one or 26323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 more portions of the handheld device and discard any sensor measurements of the physiological parameters during periods where the contact between a finger or a palm of the user and one or more portions of the handheld device is insufficient.

[0071] While forces are provided as an example of how to assess contact between the handheld device and the user, it can be appreciated that other methods of assessing contact can be implemented. For example, contact can be assessed using other types of sensors (e.g., impedance sensors, displacement sensors, optical sensors, etc.). The handheld device can use one or more sensors to determine whether the contact between the handheld device and the user has met one or more criteria, and then base when to collect or keep measurements of the physiological parameters on that assessment.

[0072] Optionally, in some embodiments, the handheld device (e.g., via its processor 912) may also assess the posture of the patient. For example, the handheld device may assess whether the orientation of the device, when it is placed against the skin of the user, is indicative of a certain posture of the patient. It can be desirable for the patient to be in certain predetermined postures (e.g., a supine posture) when capturing physiological signal(s) of the user. Therefore, the handheld device (e.g., via one or more sensors such as one or more accelerometers or an inertial measurement unit) can determine the orientation of the device and assess a posture of the user. If the posture of the user deviates from the predetermined or expected posture for capturing physiological signal(s), then the handheld device may indicate to the user (e.g., via one or more output devices as described above) that the posture of the user may need to be adjusted. In some embodiments, the handheld device may monitor to determine when the patient is in a predetermined posture, and after determining that the user is in the predetermined posture, initial measurements of one or more physiological parameters of the patient, at 608. Alternatively, or additionally, the handheld device may monitor to determine when the patient is in a predetermined posture, and discard any sensor measurements of the physiological parameters during periods when the user is not in the predetermined posture.

[0073] Optionally, at 604, the handheld device can generate one or more acoustic and / or vibrational signals to assess one or more conditions associated with the patient and / or the handheld device. The handheld device can include a speaker and / or a vibrating device (e.g., a transducer) for generating the acoustic and / or vibrational signals. At 606, the handheld device can analyze the signals measured by one or more sensors of the handheld device in response to the acoustic and / or vibration signal(s) to assess the one or more conditions. For example, the handheld device can generate one or more acoustic signals and / or mechanical vibrations, and measure feedback from the patient in response to those signals, e.g., to perform active 27323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 auscultation (e.g., percussion) based assessments of fluid, to measure biomechanical properties of the skin and / or musculoskeletal system of the patient, and / or to perform other measurements and / or assessments. In some embodiments, the feedback measured by the one or more sensors of the handheld device can be analyzed to extract information regarding a fluid level in the lungs and / or chest cavity of the patient. Such can be further analyzed, e.g., at 612, to assess heart failure, pleural effusion, and / or other conditions or parameters of the patient.

[0074] Optionally, at 607, the method 600 can include generating feedback (e.g., visual, audio, haptic) to alert the user to deviations from predefined operating criteria of the handheld sensing device and / or to present guidance to the user to meet the predefined operating criteria. Predefined operating criteria can include a predefined posture for the patient (e.g., supine), a predetermined activity level for the patient (e.g., is the user at rest or sleeping), predefined criteria associated with proper positioning of the device against the patient, etc. The handheld device (e.g., via its processor 912) and / or another compute device (e.g., compute device 940) can be configured to generate the feedback and / or present the guidance so that the user can adjust the positioning of the handheld device, adjust his or her activity level, and / or otherwise change a condition or operation of the handheld device.

[0075] At 608, the handheld device can measure using one or more sensors (e.g., sensor(s) 916), signals of one of more physiological parameters of the patient. This can include, for example, a SCG waveform, PPG waveform, ECG waveform, heart rate, blood pressure, and / or the like.

[0076] At 610, the handheld device (e.g., via its processor 912) and / or another compute device (e.g., compute device 940) can be configured to process the signals measured by the one or more sensors to extract features from the signals and / or to remove noise and / or distortion from the signals. In some embodiments, the handheld device can be configured to send the physiological signal(s) measured by the one or more sensors to the other compute device (e.g., compute device 940), such that the compute device can processor and / or analyze the signals. In some embodiments, the handheld device can be configured to perform onboard processing of the physiological signal(s) measured by the one or more sensors. The processing of the signals of the one or more physiological parameters can include: filtering the signals to remove noise in the signals, combining and / or averaging the signals, segmenting and / or cropping the signals (e.g., to remove noise and / or outlier data), etc.

[0077] Optionally, at 612, the handheld device (e.g., via its processor 912) and / or another compute device (e.g., compute device 940) can be configured to assess one or more cardiopulmonary-related parameter(s) of the patient, such as, for example, a predictive clinical 28323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 status of heart failure or another heart conditions and / or other conditions or parameters of the patient. The handheld device and / or other compute device can be configured to implement one or more algorithms or models (e.g., a machine learning model, a language model, an encoder- decoder model, etc.) to generate one or more outputs of a cardiopulmonary-related parameter of the patient. The assessment of the cardiopulmonary-related parameters can include: changes in filling characteristics of the heart of a user (e.g., changes in hemodynamics, filling pressure, pulmonary artery (PA) pressure, pulmonary capillary wedge pressure (PCWP), and the like, or any combination thereof), changes in pulmonary characteristics of the user (e.g., pleural effusion), and / or a clinical likelihood of heart failure of the patient.

[0078] At 614, the handheld device (e.g., via I / O device 918) and / or another compute device (e.g., compute device 940) can be configured to output information associated with the one or more physiological parameters and / or cardiopulmonary-related parameters of the patient. For example, the handheld device or another compute device can include a display that is configured to present information of one or more physiological parameters and / or cardiopulmonary-related parameters of the patient.

[0079] FIG.7 is a flow chart illustrating a method 700 for capturing and / or determining one or more physiological parameter(s) and / or cardiopulmonary-related parameter(s) of a patient, according to embodiments. The method can be executed by any of the systems and devices described herein, for example, the systems including an implantable device described with respect to FIGS. 1, 3, 4, and 8. While the method 700 is more applicable to systems including an implantable device, it can be appreciated that one or more steps of method 700 can be similar to those of method 600 described above.

[0080] At 702, the method 700 can include assessing a proximity between an implanted sensing device (e.g., implantable sensing device 810) and an external device (e.g., external device 820, or a handheld device such as, for example, handheld device 910) and / or optionally assessing a posture of the patient and / or contact between the sensor(s) and the patient. Assessing the proximity between the implanted sensing device and an external device can include sensing signals between the implanted sensing device and the external device to determine a distance between the two devices. Assessing the posture of the patient can be similar to that described with respect to 602 of FIG. 6. In some embodiments, the posture of the patient can be determined by sensor(s) of the implanted sensing device. In some embodiments, the posture of the patient can be determined by sensor(s) of the external device. Assessing the sensor contact between the sensor(s) and the patient can be similar to that described with respect to 602 of FIG. 6. 29323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033

[0081] Optionally, at 704, the external device can generate one or more acoustic and / or vibrational signals to assess one or more conditions associated with the patient, the implanted device, and / or the external device. The external device can include a speaker and / or a vibrating device (e.g., a transducer) for generating the acoustic and / or vibrational signals. At 706, the external device can analyze the signals measured by one or more sensors of the external device and / or implanted device in response to the acoustic and / or vibration signal(s) to assess the one or more conditions. For example, the external device can generate one or more acoustic signals and / or mechanical vibrations, and measure feedback captured by sensor(s) in response to those signals, e.g., to assess an anatomical location of the implanted sensing device. The generated acoustic and / or mechanical vibrations can be captured by sensor(s) of the implanted sensing device. The signals captured by the sensor(s) of the implanted device can then be transmitted (e.g., via communications interface 819) to the external device, so that the external device can determine a location of the implanted sensing device. If the location of the implanted sensing device has migrated or changed, then the external device and / or implanted sensing device may adjust their operating parameters to account for the change. For example, the implanted sensing device can be configured to capture data using different or additional onboard sensor(s). The external device can be configured to generate signals (e.g., auditory and / or vibrational signals) to assess the anatomical structures around the implanted device, e.g., to use such information to adjust the physiological signal(s) captured by sensors of the implanted device. In some embodiments, information indicative of the location of the implanted sensing device can be factored into subsequent processing and / or analysis of the physiological signal(s) captured by one or more sensors of the implanted sensing device and / or external device. The location of the implanted sensing device can be used to adjust the physiological signal(s) captured by the sensor(s), e.g., for assessing one or more physiological parameters or cardiopulmonary-related parameters of the patient. For example, the physiological signal(s) captured by sensors of the implanted device may be scaled by a factor (e.g., to account for a weaker signal given migration away from a target location), the physiological signal(s) captured by sensors of the implanted device can be filtered using additional filters and / or noise reduction algorithms to remove additional noise (e.g., respiratory noise) due to migration of the implanted device, etc. In some embodiments, similar to that described with reference to 604 and 606 of FIG. 6, the external device can generate one or more acoustic signals and / or mechanical vibrations, and measure feedback from the patient in response to those signals, e.g., to perform active auscultation (e.g., percussion) based assessments of fluid, to measure biomechanical properties of the skin and / or 30323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 musculoskeletal system of the patient, and / or to perform other measurements and / or assessments.

[0082] Optionally, at 707, the method 700 can include generating feedback (e.g., visual, audio, haptic) to alert the user to deviations from predefined operating criteria of the implanted sensing device and / or the external device. Optionally, the method 700 can also include presenting guidance to the user to meet the predefined operating criteria. Predefined operating criteria can include a predefined posture for the patient (e.g., supine), a predetermined activity level for the patient (e.g., is the user at rest or sleeping), predefined criteria associated with proper positioning of the external device against the patient, predefined criteria associated with an expected location of the implanted sensing device, etc. The external device (e.g., via its processor 822) and / or another compute device (e.g., compute device 840) can be configured to generate the feedback and / or present the guidance so that the user can adjust the positioning of the external device, adjust his or her activity level, and / or otherwise change a condition or operation of the implanted device and / or external device. In some embodiments, if the position of the implanted sensing device has significantly migrated, the feedback may include alerting the patient to the migration and instructing the patient to seek guidance from a physician.

[0083] At 708a, the implanted sensing device can be configured to measure, using one or more sensors (e.g., sensors 816), signals of one or more physiological parameter(s) of the patient. As described above, this can include, for example, ECG signal(s), SCG signal(s), impedance data, biochemical sensing (e.g., level of biomarkers), auscultation signals (e.g., of heart sounds), etc. Optionally, at 708b, the exgternal device can measure using one or more sensors (e.g., sensor(s) 826), signals of one of more physiological parameters of the patient. This can include, for example, a SCG waveform, PPG waveform, ECG waveform, heart rate, blood pressure, and / or the like. At 710, the implanted sensing device can transmit, via its communications interface (e.g., communications interface 819), the signals measured by one or more sensors of the implanted sensing device to the external device.

[0084] At 712, the external device (e.g., via its processor 822) and / or another compute device (e.g., compute device 840) can be configured to process the signals measured by the one or more sensors to extract features from the signals and / or to remove noise and / or distortion from the signals. In some embodiments, the external device can be configured to send the physiological signal(s) measured by the one or more sensors to the other compute device (e.g., compute device 840), such that the compute device can processor and / or analyze the signals. In some embodiments, the external device can be configured to perform onboard processing of 31323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 the physiological signal(s) measured by the one or more sensors. The processing at 712 can be similar to that described with reference to 610 of FIG. 6.

[0085] Optionally, at 714, the external device (e.g., via its processor 822) and / or another compute device (e.g., compute device 840) can be configured to assess one or more cardiopulmonary-related parameter(s) of the patient, e.g., similar to 612 of FIG. 6.

[0086] At 716, the external device (e.g., via I / O device 828) and / or another compute device (e.g., compute device 840) can be configured to output information associated with the one or more physiological parameters and / or cardiopulmonary-related parameters of the patient. For example, the external device or another compute device can include a display that is configured to present information of one or more physiological parameters and / or cardiopulmonary- related parameters of the patient.

[0087] It should be understood that the disclosed embodiments are not intended to be exhaustive, and functional, logical, operational, organizational, structural and / or topological modifications can be made without departing from the scope of the disclosure. As such, all examples and / or embodiments are deemed to be non-limiting throughout this disclosure.

[0088] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0089] Examples of computer code include, but are not limited to, micro-code or micro- instructions, machine instructions, such as produced by a compiler, code used to produce a web service, and files containing higher-level instructions that are executed by a computer using an interpreter. For example, embodiments can be implemented using Python, Java, JavaScript, C++, and / or other programming languages and development tools. Additional examples of computer code include, but are not limited to, control signals, encrypted code, and compressed code.

[0090] The drawings primarily are for illustrative purposes and are not intended to limit the scope of the subject matter described herein. The drawings are not necessarily to scale; in some instances, various aspects of the subject matter disclosed herein can be shown exaggerated or enlarged in the drawings to facilitate an understanding of different features. In the drawings, like reference characters generally refer to like features (e.g., functionally similar and / or structurally similar elements).

[0091] The acts performed as part of a disclosed method(s) can be ordered in any suitable way. Accordingly, embodiments can be constructed in which processes or steps are executed in an order different than illustrated, which can include performing some steps or processes 32323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 simultaneously, even though shown as sequential acts in illustrative embodiments. Put differently, it is to be understood that such features can not necessarily be limited to a particular order of execution, but rather, any number of threads, processes, services, servers, and / or the like that can execute serially, asynchronously, concurrently, in parallel, simultaneously, synchronously, and / or the like in a manner consistent with the disclosure. As such, some of these features can be mutually contradictory, in that they cannot be simultaneously present in a single embodiment. Similarly, some features are applicable to one aspect of the innovations, and inapplicable to others.

[0092] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the disclosure. That the upper and lower limits of these smaller ranges can independently be included in the smaller ranges is also encompassed within the disclosure, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.

[0093] As used herein, the term “about” or “generally” or the like in the context of a given value or range (whether direct or indirect, e.g., “generally in line”, “generally aligned”, “generally parallel”, etc.) refers to a value or range that is within 10%, and preferably within 5%, of the given value or range.

[0094] The phrase “and / or,” as used herein in the specification and in the embodiments, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and / or” should be construed in the same fashion, i.e., “one or more” of the elements so conjoined. Other elements can optionally be present other than the elements specifically identified by the “and / or” clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to “A and / or B”, when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.

[0095] As used herein in the specification and in the embodiments, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when separating items in a list, “or” or “and / or” shall be interpreted as being inclusive, i.e., the inclusion of at least 33323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 one, but also including more than one of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of” or “exactly one of,” or, when used in the embodiments, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e., “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “only one of,” or “exactly one of.” “Consisting essentially of,” when used in the embodiments, shall have its ordinary meaning as used in the field of patent law.

[0096] As used herein in the specification and in the embodiments, the phrase “at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements can optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, “at least one of A and B” (or, equivalently, “at least one of A or B,” or, equivalently “at least one of A and / or B”) can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc.

[0097] In the embodiments, as well as in the specification above, all transitional phrases such as “comprising,” “including,” “carrying,” “having,” “containing,” “involving,” “holding,” “composed of,” and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases “consisting of” and “consisting essentially of” shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.

[0098] Some embodiments described herein relate to a computer storage product with a non- transitory computer-readable medium (also can be referred to as a non-transitory processor- readable medium) having instructions or computer code thereon for performing various computer-implemented operations. The computer-readable medium (or processor-readable medium) is non-transitory in the sense that it does not include transitory propagating signals 34323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 per se (e.g., a propagating electromagnetic wave carrying information on a transmission medium such as space or a cable). The media and computer code (also can be referred to as code) can be those designed and constructed for the specific purpose or purposes. Examples of non-transitory computer-readable media include, but are not limited to, magnetic storage media such as hard disks, floppy disks, and magnetic tape; optical storage media such as Compact Disc / Digital Video Discs (CD / DVDs), Compact Disc-Read Only Memories (CD-ROMs), and holographic devices; magneto-optical storage media such as optical disks; carrier wave signal processing modules; and hardware devices that are specially configured to store and execute program code, such as Application-Specific Integrated Circuits (ASICs), Programmable Logic Devices (PLDs), Read-Only Memory (ROM) and Random-Access Memory (RAM) devices. Other embodiments described herein relate to a computer program product, which can include, for example, the instructions and / or computer code discussed herein.

[0099] Some embodiments and / or methods described herein can be performed by software (executed on hardware), hardware, or a combination thereof. Hardware modules can include, for example, a processor, a field programmable gate array (FPGA), and / or an application specific integrated circuit (ASIC). Software modules (executed on hardware) can include instructions stored in a memory that is operably coupled to a processor and can be expressed in a variety of software languages (e.g., computer code), including C, C++, Java™, Ruby, Visual Basic™, and / or other object-oriented, procedural, or other programming language and development tools. Examples of computer code include, but are not limited to, micro-code or micro-instructions, machine instructions, such as produced by a compiler, code used to produce a web service, and files containing higher-level instructions that are executed by a computer using an interpreter. For example, embodiments can be implemented using imperative programming languages (e.g., C, Fortran, etc.), functional programming languages (Haskell, Erlang, etc.), logical programming languages (e.g., Prolog), object-oriented programming languages (e.g., Java, C++, etc.) or other suitable programming languages and / or development tools. Additional examples of computer code include, but are not limited to, control signals, encrypted code, and compressed code. 35323620922

Claims

Attorney Docket No.: CRDS-006 / 01WO 348698-2033 CLAIMS We claim:

1. A system, comprising: an implantable device configured to be implanted in a chest of a user, the implantable device including a first set of one or more sensors configured to measure a first set of one or more physiological parameters of the user; an external device configured to be positioned against the chest of the user near the implantable device such that the implantable device is configured to transmit signals of the first set of physiological parameters to the external device, the external device including a second set of one or more sensors configured to measure a second set of one or more physiological parameters of the user; and a processor operatively coupled to the first set of sensors and the second set of sensors, the processor configured to: receive, from at least one sensor of the first set of sensors or the second set of sensors, a signal indicative of the implantable device and the external device being within a predetermined distance from one another; in response to receiving the signal, obtain the signals of the first set of physiological parameters and signals of the second set of physiological parameters; and process the signals of the first set of physiological parameters and the signals of the second set of physiological parameters to determine one or more cardiopulmonary parameters of the user.

2. The system of claim 1, wherein the second set of sensors of the external device includes at least one contact force sensor, the contact force sensor configured to measure forces associated with a contact between the external device and the chest of the user, the processor further configured to receive the forces measured by the contact force sensor and assess the contact between the external device and the chest of the user, the processor configured to obtain the signals of the second set of physiological parameters after determining that the contact between the external device and the chest of the user meets the predetermined criterion. 36323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 3. The system of claim 1, wherein the second set of sensors of the external device includes at least one contact force sensor, the contact force sensor configured to measure forces associated with a contact between the external device and the chest of the user, the processor further configured to: receive the forces measured by the contact force sensor and assess the contact between the external device and the chest of the user; and discard portions of the signals of the second set of physiological parameters when the contact between the external device and the chest of the user does not meet a predetermined criterion.

4. The system of claim 1, wherein the implantable device is disposed in a position near the clavicle of the user, a position near the pectoral of the user, or a position under the sternum of the user.

5. The system of claim 1, wherein the first set of sensors includes one or more electrodes configured to measure an electrocardiogram of the user, and an accelerometer configured to measure a seismocardiogram of the user.

6. The system of claim 1, wherein the second set of sensors includes at least one of: one or more electrodes configured to measure an electrocardiogram of the user, an accelerometer configured to measure a seismocardiogram of the user, or an optical sensor configured to measure a photoplethysmogram of the user.

7. The system of claim 1, wherein the first set of sensors includes a first accelerometer configured to measure a seismocardiogram of the user, and the second set of sensors includes a second accelerometer configured to measure the seismocardiogram of the user, the processor configured to obtain a first signal indicative of the seismocardiogram of the user from the first accelerometer and a second signal indicative of the seismocardiogram of the user from the second accelerometer, the processor further configured to reduce noise or correct for distortion in the first signal based on the second signal.

8. The system of claim 1, wherein the first set of sensors or the second set of sensors includes a sensor configured to measure a signal indicative of a posture of the user, and 37323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 the processor is further configured to receive the signal indicative of the posture of the user and determine whether the posture of the user is a predetermined posture, the processor configured to obtain the signals of the first set of physiological parameters and the signals of the second set of physiological parameters after determining that the posture of the user is the predetermined posture.

9. The system of claim 8, wherein the processor is further configured to, in response to determining that the posture of the user is not he predetermined posture, generate an alert to indicate to the user to change the posture.

10. The system of claim 1, wherein the processor is further configured to: generate, using the external device, acoustic signals and / or vibratory signals; receive a feedback signal measured by at least one sensor of the first set of sensor or the second set of sensors; and determine whether a location of the implantable device in the chest of the user has changed, the processor configured to process the signals of the first set of physiological parameters and the signals of the second set of physiological parameters based on the location of the implantable device.

11. The system of claim 1, wherein the one or more cardiopulmonary parameters of the user includes at least one of: a filling characteristic of the heart of the user, or a fluid level in a pleural space of the user.

12. The system of claim 11, wherein the filling characteristic of the heart includes one of: a filling pressure, a pulmonary artery pressure, or a pulmonary capillary wedge pressure.

13. A system, comprising: a sensing device configured to be gripped by a hand of the user, the sensing device including: a housing including a grip and a surface configured to contact a chest of the user; 38323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 a first sensor disposed on a surface of the housing near the grip such that a portion of the hand of the user contacts the first sensor when the hand is gripping the sensing device; and a second sensor disposed on the surface configured to contact the chest of the user such that the second sensor contacts the chest of the user when the user places the sensing device against the chest of the user; and a processor operatively coupled to the sensing device, the processor configured to: receive, from the sensing device, signals of one or more physiological parameters of the user; and process the signals of the one or more physiological parameters of the user to determine one or more cardiopulmonary parameters of the user.

14. The system of claim 13, wherein the processor is disposed in the housing of the sensing device.

15. The system of claim 13, wherein the first sensor is a first electrode, and the second sensor is a second electrode, the first and second electrodes configured to measure an electrocardiogram (ECG) of the user.

16. The system of claim 15, further comprising a third sensor disposed on the surface near the grip or the surface configured to contact the chest, the third sensor being an optical sensor configured to measure a photoplethysmogram (PPG) signal of the user.

17. The system of claim 13, wherein the first sensor is a first optical sensor configured to measure a first photoplethysmogram (PPG) signal of the user, and the second sensor is a second optical sensor configured to measure a second photoplethysmogram (PPG) signal of the user, the processor being configured to process the signals of the one or more physiological parameters of the user by combining the first PPG signal and the second PPG signal, or by reducing noise in one of the first PPG signal and the second PPG signal using the other of the first PPG signal and the second PPG signal. 39323620922Attorney Docket No.: CRDS-006 / 01WO 348698-2033 18. The system of claim 13, wherein the sensing device further includes a third sensor disposed within the housing, the third sensor being an accelerometer configured to measure a seismocardiogram signal of the user.

19. The system of claim 18, wherein the sensing device further includes a fourth sensor configured to measure one or more sounds of a heart or a lung of the user.

20. The system of claim 13, wherein the housing includes portions formed of an elastomeric material to enhance the grip and engagement with the chest of the user.

21. The system of claim 13, wherein the sensing device further includes a force sensor, the force sensor configured to measure forces associated with a contact between the surface configured to contact the chest of the user and the chest of the user, the processor further configured to: receive the forces measured by the force sensor and assess the contact between the surface and the chest of the user; and in response to determining that the contact between the surface and the chest of the user does not meet a predetermined criterion, generate feedback to the user. 40323620922

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