CN221331242U

CN221331242U - Guide and apparatus and system for non-invasively detecting and monitoring medical conditions using multiple sensing modalities

Info

Publication number: CN221331242U
Application number: CN202322325510.3U
Authority: CN
Inventors: V·戈匹纳杉; T·阿克勒; J·E·D·赫维茨; A·雷诺兹; G·S·里昂; S·斯里达尔
Original assignee: Analog Devices International ULC
Current assignee: Analog Devices International ULC
Priority date: 2019-01-14
Filing date: 2020-01-14
Publication date: 2024-07-16
Anticipated expiration: 2030-01-14
Also published as: CN219680653U

Abstract

The present disclosure relates to guides and devices and systems for non-invasively detecting and monitoring medical conditions using a variety of sensing modalities. Devices, systems, and methods for non-invasively detecting and monitoring medical conditions using a plurality of sensing modalities, including: the system comprises at least two electrodes configured to be positioned on a subject, an acoustic sensor configured to be positioned on the subject, a thoracic impedance measurement module connected with the electrodes for measuring a first impedance between the electrodes, and a heart sound measurement module connected with the acoustic sensor for detecting and measuring heart sounds from the acoustic sensor.

Description

Guide and apparatus and system for non-invasively detecting and monitoring medical conditions using multiple sensing modalities

The present utility model is an utility model patent application of which the application date is 14 from 1 month in 2020, the filing date of the division is 24 from 2022, the application number is 202221599018.4, and the utility model name is "a device for capturing measurement values related to the health of a subject", and the utility model patent application 202221599018.4 is a division application of which the international application date is 14 from 01 month in 2020, the international application number is PCT/EP2020/050813, the date of entering China national stage is 2021, 08, 04, the national application number is 202090000361.5, and the utility model name is "a multi-sensor device for monitoring health".

RELATED APPLICATIONS

The present disclosure claims priority from U.S. provisional application No.62/923,214 entitled "multisensor device for health monitoring" filed on 10 month 18 of 2019 and U.S. provisional application 62/792,263 entitled "multisensor device for health monitoring" filed on 14 of 2019, the disclosures of which are incorporated by reference in their entireties.

Technical Field

The present application relates generally to systems, devices and methods for managing medical or health conditions in a human subject, and more particularly to systems, devices and methods for noninvasively detecting and monitoring medical or health conditions, such as Congestive Heart Failure (CHF), chronic Obstructive Pulmonary Disease (COPD), and other chronic diseases of a human subject employing multiple sensing modalities.

Background

Congestive Heart Failure (CHF) is a known heart disease in a human subject in which the damaged myocardium loses the ability to pump out sufficient amounts of blood to meet physical demands. In the early stages of CHF, this inability to pump sufficient blood occurs only when a human subject is in motion. However, in the more advanced stages of CHF, even if a human subject is at rest, there may be occurrences that a sufficient amount of blood cannot be pumped. CHF is one of the most frequently diagnosed heart diseases in hospitalized patients over 65 years old and is also one of the most common causes of readmission of such patients within 30 days. In recent years, the 30-day readmission cost for CHF has increased to 18 billion dollars per year, with a readmission cost of about $13,000 per readmission, and a readmission rate of 25%. Some reasons for such patient readmission may include, but are not limited to: (1) patients do not follow diet and medication, which can lead to excessive or extreme dehydration of the lungs, (2) incomplete titration of the medication dose, which typically requires modification as the patient moves back to his or her home from the hospital environment, and (3) atrial fibrillation, which can occur after the patient is discharged from the hospital.

Management of CHF in a patient after discharge has traditionally focused on monitoring fluid retention in the patient using sensors in an implantable cardiac device, such as an Implantable Cardioverter Defibrillator (ICD), cardiac resynchronization therapy-defibrillator (CRT-D), or pacemaker. Such implantable cardiac devices can detect the occurrence of pulmonary congestion in a patient by measuring the patient's thoracic fluid impedance. For example, an ICD, CRT-D, or pacemaker or like implantable cardiac device may be configured to deliver electrical current through the patient's lungs and measure the resulting intrathoracic sensitivity. As the patient's chest fluid accumulates during pulmonary congestion, the conductance across the patient's lungs increases, resulting in a corresponding decrease in impedance, indicating the level of chest fluid accumulation. Such implantable cardiac devices can also be interrogated by a hospital clinician, allowing the hospital clinician to monitor the patient's fluid status and receive early warning of changes that may be predictive of impending fluid overload. Based on the fluid status monitored by the patient, the hospital clinician can then determine whether it is appropriate to readmission the patient for further monitoring and/or treatment.

Disclosure of utility model

Systems, methods, and devices for non-invasively detecting and/or monitoring medical conditions are disclosed. Medical conditions that may be detected and/or monitored may include chronic conditions such as Congestive Heart Failure (CHF), chronic Obstructive Pulmonary Disease (COPD), other cardiac conditions, and other pulmonary conditions. According to some embodiments, an apparatus for non-invasively detecting and monitoring a medical condition using a plurality of sensing modalities includes: the system comprises at least two electrodes configured to be positioned on a subject, an acoustic sensor configured to be positioned on the subject, a thoracic impedance measurement module connected with the at least two electrodes for measuring a first impedance between the at least two electrodes, and a heart sound measurement module connected with the acoustic sensor for detecting and measuring heart sounds from the acoustic sensor. In some embodiments, the heart sound is an S3 heart sound. In other embodiments, the heart sound is an S4 heart sound. In various embodiments, the acoustic sensor is at least one of an ultrasonic sensor and a piezoelectric microphone sensor. In some embodiments, the at least two electrodes comprise two electrode pairs, and each electrode pair comprises a force electrode and a sense electrode. The force electrode is configured to apply power (e.g., current or voltage) to the subject and the sense electrode is configured to sense a change caused by the applied power. The change may include a change in voltage drop between the electrode and/or the electrode pair, a change in current between the electrode and/or the electrode pair, a change in conductance between the electrode and/or the electrode pair, or some combination thereof.

In some embodiments, the device includes a sensor for determining the orientation of the device. In one embodiment, the thoracic impedance measurement module measures a first impedance when the device is in a first orientation and measures a second impedance when the device is in a second orientation. In other examples, the first direction indicating device is approximately horizontal and the second direction indicating device is approximately vertical. In other examples, the first direction indicating device is approximately horizontal and the second direction indicating device is positioned at an angle between about 30 degrees and about 90 degrees relative to horizontal. In other examples, the first direction indicating device is approximately horizontal and the second direction indicating device is positioned at an angle greater than about 30 degrees relative to the horizontal. In one example, the second direction indicating device is in a Fowler position. In some embodiments, the thoracic impedance measurement module automatically measures the first impedance at regular intervals.

In some embodiments, the device further comprises an electrocardiogram measuring module connected to the electrodes for measuring electrical activity between the electrodes.

According to some embodiments, a system for non-invasively detecting and monitoring medical conditions using a plurality of sensing modalities, comprises: an apparatus positioned on an object, having a plurality of surface sensors and a plurality of sensing modules connected to the plurality of surface sensors, configured to collect multi-modal sensing data; and a data analyzer for performing at least one of data analysis, data trend analysis, and data reduction of the multi-modal sensed data. The multi-modal sensing data includes a first impedance between at least two surface sensors, and heart sounds from at least one of the plurality of surface sensors. In various embodiments, the surface sensor comprises at least one of an electrode, a heart sound sensor, an ultrasonic sensor, and a photoplethysmographic pulse wave sensor.

In some embodiments, the system further comprises a data decision engine configured to combine at least some of the multi-modal sensed data, wherein the combined multi-modal sensed data is indicative of a state of the medical condition of the subject. In some implementations, the system further includes a transceiver configured to transmit the combined multi-modal sensed data to the cloud over at least one wireless communication path for further processing.

In some embodiments, the device in the system further comprises a sensor for determining the direction of the device. In some embodiments, the apparatus comprises: a thoracic impedance measurement module configured to measure a first impedance when the device is in a first orientation and a second impedance between the at least two surface sensors when the device is in a second orientation. In some embodiments, the apparatus in the system further comprises an electrocardiogram measurement module connected to the plurality of surface sensors, the electrocardiogram measurement module for measuring electrical activity between at least two surface sensors.

According to some embodiments, a method for non-invasively detecting and monitoring a medical condition using a plurality of sensing modalities includes: transdermally delivering an electrical current from a first electrode positioned on a subject; receiving the current percutaneously at a second electrode located on the subject; measuring a voltage between the first and second electrodes; determining a thoracic impedance based at least on the voltage; receiving an acoustic signal from an acoustic sensor; measuring heart sounds from the acoustic sensor; and transmitting the chest impedance data and the heart sound measurements to a data analyzer configured to perform at least one of data analysis, data trend analysis, and data restoration of the chest impedance data and the heart sound measurements. In some embodiments, the method further comprises measuring electrical activity between the first electrode and the second electrode and generating an electrocardiogram.

In some embodiments, the method further comprises determining the orientation of the device. In some embodiments, the thoracic impedance is determined when the device is in a first orientation, and the method further comprises determining a second impedance measurement between the first electrode and the second electrode when the device is in a second orientation.

In accordance with the present application, systems, devices, and methods are disclosed for non-invasively detecting and monitoring medical or health conditions (e.g., chronic diseases, including CHF) in a human subject using a variety of sensing modalities, including, but not limited to, chest impedance sensing, electrocardiogram (ECG) sensing, respiratory rate sensing, tidal volume sensing, heart sound sensing, pulse oximetry sensing, blood pressure (systolic, diastolic) sensing, cardiac output sensing, and the like. The disclosed systems, devices, and methods may non-invasively collect and at least partially analyze, trend, and/or reduce data from each sensing modality and data fuse some or all of the multi-modality sensing data to obtain selected data that may be used to detect chronic episodes and/or monitor severity in a human subject. The disclosed systems, devices, and methods may also transmit such multimodal sensory data (and other information related to the onset and/or severity of chronic disease in a human subject) directly to the "cloud" over a communication network, or a smart phone or other communication device, which in turn may transmit the multimodal sensory data and/or other information to the cloud over the communication network. The multi-modal sensing data may also be analyzed, trended, reduced, and/or fused in the cloud to enhance or at least partially replace the data analysis, trended, reduced, and/or fused performed by the disclosed systems, apparatuses, and methods. The resulting curated multimodal sensing data and/or other information may then be downloaded remotely from the cloud by a hospital clinician for monitoring and/or tracking purposes. By non-invasively collecting and analyzing data from multiple sensing modalities to detect the onset and/or monitoring severity of chronic disease in a human subject, the disclosed systems, devices, and methods can increase positive detection of potentially problematic chronic disease while reducing false positives, thereby reducing unnecessary readmission times, reducing hospitalization time, and reducing hospitalization costs.

In certain embodiments, a method for non-invasively detecting and monitoring a medical or health condition (e.g., chronic disease, including Congestive Heart Failure (CHF)) in a human subject using a plurality of sensing modalities includes: the non-invasive chronic disease detection and monitoring device is positioned on the human subject such that it contacts the torso and upper chest and neck regions of the human subject or any other suitable body part or region through at least a plurality of surface electrodes and/or one or more sensors, such as heart sound sensors, ultrasound sensors, photoplethysmography (PPG) sensors, etc. Once the chronic disease detection and monitoring device is positioned in contact with the torso and upper chest and neck regions of the human subject, a plurality of multimodal sensing and measurement modules included in the chronic disease detection and monitoring device are activated to obtain multimodal sensing data from the human subject. The multi-modal sensing data may include, but is not limited to, one or more of chest impedance sensing data, electrocardiogram (ECG) sensing data, respiratory rate and tidal volume sensing data, heart rate variability/heart sound sensing data, and pulse oximetry sensing data. The multi-modal sensed data is provided to a data analyzer included in the chronic disease detection and monitoring device for at least partially analyzing, trending, and/or reducing the data. The analyzed multi-modal sensed data is then at least partially fused or combined by a data fusion/decision engine included in the chronic disease detection and monitoring device for subsequent use in making one or more inferences about the chronic disease condition state of the human subject. The at least partially fused or combined multimodal sensing data is then transmitted by a transmitter/receiver contained in the chronic disease detection and monitoring device to the cloud via one or more wireless communication paths for possible further data analysis, trend analysis, reduction and/or fusion, and subsequently downloaded remotely by a hospital clinician for monitoring and/or tracking purposes.

In certain other embodiments, an apparatus for non-invasively detecting and monitoring medical or health conditions in a human subject (e.g., chronic disease in a human subject) using a plurality of sensing modalities includes: a non-invasive chronic state detection and monitoring device is positioned on a human subject so as to contact torso and upper chest and neck regions or any other suitable body part or region of the human subject by at least a plurality of surface electrodes and/or one or more sensors, such as heart sound sensors, ultrasound sensors, photoplethysmography (PPG) sensors, etc. The slow state detection and monitoring device comprises a plurality of multi-modal sensing and measurement modules, a data analyzer, a data fusion/decision engine, and a transmitter/receiver. The plurality of multi-modal sensing and measurement modules are operable to obtain multi-modal sensed data from a human subject including, but not limited to, chest impedance sensed data, ECG sensed data, respiratory rate and tidal volume sensed data, heart rate variability/heart sound based sensed data, and pulse oximetry sensed data. The data analyzer is operable to perform at least a portion of data analysis, data trend analysis, and/or data reduction on the multimodal sensory data. The data fusion/decision engine is operable to at least partially fuse or combine the analyzed multimodal sensory data for subsequent use in making one or more inferences about the chronic condition of the human subject. The transmitter/receiver is operable to transmit at least partially fused or combined multimodal sensing data over one or more wireless communication paths to the cloud for possible further data analysis, trend analysis, reduction and/or fusion, and subsequent remote download by a hospital clinician for monitoring and/or tracking.

According to one aspect of the present disclosure, there is provided a guide for positioning a wearable device for measuring a health characteristic of a subject, and comprising: a first portion positioned around the neck of the subject, the first portion for supporting a guide around the neck of the subject when positioned around the neck of the subject; and a second portion at an end of the guide opposite the first portion for engagement with the wearable device to indicate the proper position of the wearable device on the subject.

In a preferred embodiment, wherein the first portion comprises a neck piece positioned around the neck of the subject, wherein the second portion comprises a positioning piece, wherein the neck piece comprises a first mounting portion and the positioning piece comprises a second mounting portion for adjustably mounting the positioning piece to the first mounting portion of the positioning piece, and wherein the position at which the second mounting portion is mounted to the first mounting portion can be adjusted to provide a proper position on the subject for a wearable device.

In a preferred embodiment, wherein an edge of the positioning workpiece is used to abut against a portion of the wearable device to indicate the proper position of the wearable device on the object.

In a preferred embodiment, wherein the neck workpiece comprises a first positioning element on a first side of the neck workpiece and a second positioning element on a second side of the neck workpiece, the second side being opposite the first side, wherein the first positioning element is for contacting a first portion of the neck of the subject and the second positioning element is for contacting a second portion of the neck of the subject such that the neck workpiece is intermediate around the neck of the subject.

In a preferred embodiment, wherein the first portion comprises a hook, wherein the second portion comprises a socket, wherein the socket is located towards an end of the guide opposite the hook, and wherein the socket is for engagement with a portion of the wearable device to indicate the proper position of the wearable device on the subject.

According to yet another aspect of the present disclosure, there is provided an apparatus for non-invasively detecting and monitoring medical conditions using a plurality of sensing modalities, the apparatus comprising: at least two electrodes configured to be positioned on an object; an acoustic sensor configured to be positioned on the object; a thoracic impedance measurement module connected to the at least two electrodes for measuring a first impedance between the at least two electrodes; and a heart sound measurement module connected with the acoustic sensor for detecting and measuring heart sounds from the acoustic sensor.

In a preferred embodiment, the device further comprises a sensor for determining the orientation of the device.

In a preferred embodiment, wherein the thoracic impedance measurement module measures a first impedance when the device is in a first orientation and a second impedance between the at least two electrodes when the device is in a second orientation.

In a preferred embodiment, wherein the first direction indicates that the device is approximately horizontal, and wherein the second direction indicates that the device is angled with respect to the horizontal.

In a preferred embodiment, wherein the thoracic impedance measurement module automatically measures the first impedance at regular intervals.

In a preferred embodiment, the device further comprises an electrocardiogram measuring module connected to the at least two electrodes for measuring the electrical activity between the at least two electrodes.

In a preferred embodiment, wherein the acoustic sensor is one of an ultrasonic sensor and a piezoelectric microphone.

In a preferred embodiment, wherein the at least two electrodes comprise two electrode pairs, each electrode pair comprising a force electrode configured to apply a current to the object and a sense electrode configured to sense a change caused by the applied current.

In a preferred embodiment, wherein the heart sound is an S3 heart sound.

According to yet another aspect of the present disclosure, there is provided a system for non-invasively detecting and monitoring medical conditions using a plurality of sensing modalities, the system comprising: an apparatus for positioning on an object, the apparatus comprising: a plurality of surface sensors; and a plurality of sensing modules connected to the plurality of surface sensors, configured to collect multi-modal sensing data, wherein the multi-modal sensing data includes a first impedance between at least two of the surface sensors and heart sounds from at least one of the plurality of surface sensors; and a data analyzer operable to perform at least one of data analysis, data trend analysis, and data restoration of the multimodal sensory data.

In a preferred embodiment, the system further comprises a data decision engine configured to combine at least some of the multi-modal sensed data, wherein the combined multi-modal sensed data is indicative of a state of a medical condition of the subject.

In a preferred embodiment, the system further comprises a transceiver configured to transmit the combined multi-modal sensed data to the cloud over at least one wireless communication path for further processing.

In a preferred embodiment, wherein the device further comprises a sensor for determining the orientation of the device.

In a preferred embodiment, wherein the device comprises a thoracic impedance measurement module configured to measure the first impedance when the device is in a first orientation and to measure a second impedance between at least two of the surface sensors when the device is in a second orientation.

In a preferred embodiment, wherein the apparatus further comprises an electrocardiogram measuring module connected to the plurality of surface sensors for measuring electrical activity between at least two of the surface sensors.

In a preferred embodiment, wherein the surface sensor comprises at least one of an electrode, a heart sound sensor, an ultrasonic sensor, and a photoplethysmographic pulse wave sensor.

According to another aspect of the present disclosure, there is also provided a guide for positioning a device on a subject, and comprising: a neck workpiece positioned around a neck of the subject; and positioning a workpiece having an indication portion that indicates a proper position of the device on the object when the neck workpiece is positioned around the neck of the object.

In a preferred embodiment, wherein the neck piece comprises a necklace portion having an annular shape with a hollow center, and wherein the neck of the subject is located within the hollow center of the necklace portion when the neck piece is positioned around the neck of the subject.

In a preferred embodiment, the guide further comprises: a first positioning element coupled to the necklace portion; and a second positioning element coupled to the necklace portion, wherein the first positioning element and the second positioning element extend inwardly from the necklace portion, and wherein the first positioning element and the second positioning element contact the neck of the subject when the neck piece is positioned around the neck of the subject to facilitate positioning of the necklace portion.

In a preferred embodiment, wherein the first positioning element is coupled to a first side of the necklace portion and the second positioning element is coupled to a second side of the necklace portion opposite the first side of the necklace portion.

In a preferred embodiment, wherein the positioning workpiece is adjustably coupled to the neck workpiece.

In a preferred embodiment, wherein the neck workpiece comprises a mounting portion, wherein the positioning workpiece comprises a mounting portion, and wherein the mounting portion of the neck workpiece couples the mounting portion of the positioning workpiece to couple the positioning workpiece to the neck workpiece.

In a preferred embodiment, wherein the indicating portion comprises positioning an edge of the workpiece, and wherein the indicating portion indicates that the device is positioned near the edge to obtain the proper position.

Other features, functions, and aspects of the present application will be apparent from the description that follows.

Drawings

For a more complete understanding of the present disclosure, and the features and advantages thereof, reference is now made to the following descriptions taken in conjunction with the accompanying drawings, in which like reference numbers represent like parts, and in which:

FIG. 1 is a diagram illustrating an environment including an example system for non-invasively detecting and monitoring a medical or health condition of a subject using multiple modalities in accordance with some embodiments of the present disclosure;

fig. 2 is a diagram illustrating example functional components of the system of fig. 1, according to some embodiments of the present disclosure.

FIG. 3 illustrates another example environment in which an example system for non-invasively detecting and monitoring medical or health conditions may be employed in accordance with some embodiments of the present disclosure;

4A-4C are diagrams illustrating an apparatus for detecting and monitoring a health condition of a subject, according to some embodiments of the present disclosure;

FIG. 5 is a diagram illustrating another apparatus for detecting and monitoring a health condition of a subject in accordance with some embodiments of the present disclosure;

FIG. 6 is a diagram illustrating another apparatus for detecting and monitoring a health condition of a subject in accordance with some embodiments of the present disclosure;

FIG. 7 illustrates another example apparatus for detecting and monitoring a health condition of a subject in accordance with some embodiments of the present disclosure;

FIG. 8 illustrates a back side of the example apparatus of FIG. 7, in accordance with some embodiments of the present disclosure;

FIG. 9 illustrates an example adhesive for maintaining an apparatus for detecting and monitoring a medical or health condition of a subject in accordance with some embodiments of the present disclosure;

FIG. 10 illustrates another example apparatus for detecting and monitoring a health condition of a subject in accordance with some embodiments of the present disclosure;

FIG. 11 illustrates an example system for non-invasively detecting and monitoring medical or health conditions in accordance with some embodiments of the disclosure;

FIG. 12 illustrates another example system for non-invasively detecting and monitoring medical or health conditions in accordance with some embodiments of the disclosure;

Fig. 13 illustrates another example base station in accordance with some embodiments of the present disclosure;

FIG. 14 illustrates another example apparatus for detecting and monitoring a health condition of a subject in accordance with some embodiments of the present disclosure;

FIG. 15 illustrates a back side of the example apparatus of FIG. 14, according to some embodiments of the present disclosure;

FIG. 16 illustrates another example apparatus for detecting and monitoring a health condition of a subject in accordance with some embodiments of the present disclosure;

FIG. 17 illustrates a back side of the example apparatus of FIG. 16, according to some embodiments of the present disclosure;

FIG. 18 illustrates an example control module according to some embodiments of the disclosure;

Fig. 19 illustrates another example base station in accordance with some embodiments of the present disclosure;

fig. 20 illustrates the base station of fig. 19, according to some embodiments of the present disclosure;

FIG. 21 illustrates an example guide according to some embodiments of the present disclosure;

FIG. 22 illustrates an example positioning arrangement according to some embodiments of the present disclosure;

FIG. 23 illustrates another example guide according to some embodiments of the present disclosure;

FIG. 24 is a flowchart illustrating an example method of detecting and/or monitoring the severity of a medical or health condition, according to some embodiments of the present disclosure;

FIG. 25 is a diagram illustrating another apparatus for detecting and monitoring a health condition of a subject in accordance with some embodiments of the present disclosure;

26A-26G are diagrams illustrating various examples of electrode and sensor torso placement for detecting and monitoring a subject's health condition, according to some embodiments of the present disclosure;

FIG. 27 illustrates an example user interface in accordance with some embodiments of the present disclosure;

FIG. 28 illustrates another example user interface in accordance with some embodiments of the present disclosure;

FIG. 29 illustrates another example user interface in accordance with some embodiments of the present disclosure;

FIGS. 30A and 30B are diagrams illustrating an example cardiovascular feedback loop;

Fig. 31 is a diagram illustrating medical classification of heart failure.

Detailed Description

Systems, devices, and methods for non-invasively detecting and monitoring medical or health conditions, such as Congestive Heart Failure (CHF) disease, chronic Obstructive Pulmonary Disease (COPD), and other chronic diseases, in a human subject using a variety of sensing modalities are disclosed. In particular, an apparatus for non-invasively collecting and analyzing, trending, and/or reducing data from each sensing modality is disclosed. The device may perform data fusion on some or all of the multi-modal sensing data to obtain planning data that may be used to detect the onset of and/or monitor the severity of the health condition of the human subject, and transmit such multi-modal sensing data (as well as other information regarding the occurrence and/or severity of the health condition of the human subject). The data may be transmitted directly to the "cloud" over a communications network, or to a smart phone or other communications device. The smart phone or other communication device may analyze the data locally or may transmit the multimodal sensory data and/or other information to the cloud over a communication network. Data transmitted to the cloud may be remotely analyzed, trended, reduced, and/or fused to augment or at least partially replace data analysis, trended, reduced, and/or fused performed by the disclosed systems, devices, and methods. In some examples, the hospital clinician may remotely download the resulting planned multimodal sensory data and/or other information from the cloud for monitoring and/or tracking the health status of the human subject.

The disclosed systems, devices, and methods for non-invasively detecting and monitoring chronic conditions in a human subject using multiple sensing modes may provide improvements over conventional implantable cardiac devices for managing chronic conditions in a human subject, such as Implantable Cardioverter Defibrillators (ICDs), cardiac resynchronization therapy defibrillators (CRT-D), or pacemakers. For example, such conventional implantable cardiac devices typically include one or more sensors configured to provide a single or limited number of sensing modalities, such as modalities for detecting fluid retention in a human subject. However, monitoring and/or tracking a chronic condition of a human subject based on only a single or limited number of sensing patterns often results in false positives, resulting in unnecessary readmission, and thus increasing hospital costs. Furthermore, such conventional implantable cardiac devices often fail to analyze the correlation of multi-modal sensing data to obtain positive detection of potentially problematic chronic diseases in a human subject. Furthermore, the implantable nature of such conventional cardiac devices can increase the risk of surgery and the incidence of infection. Furthermore, the implantable nature of such conventional cardiac devices limits the usability of the device for patients, as only patients who are eligible to undergo surgery to insert an implant can receive the device.

The disclosed systems, devices, and methods for non-invasively detecting and monitoring medical or health conditions (e.g., chronic diseases, including CHF, COPD, other heart diseases, and other pulmonary diseases) of a human subject can non-invasively collect data and at least partially analyze, trend, and/or reduce data from a variety of sensing modalities. In addition, the systems, devices, and methods may perform data fusion on some or all of the multimodal sensory data and obtain planning data that may be used to detect chronic episodes, as well as to monitor the severity of chronic illness in a human subject. The disclosed systems, devices, and methods thus increase positive detection of potentially problematic chronic diseases while reducing false positives, which may reduce unnecessary readmission times, reduce hospitalization time, and reduce hospitalization costs. Furthermore, the disclosed systems, devices and methods for non-invasively detecting and monitoring chronic diseases may be implemented in external devices that may be conveniently used by human subjects after discharge from a hospital, allowing the human subjects as well as hospital clinicians to monitor the chronic disease status of the subjects while reducing the risk of surgery and/or infection.

Worsening heart failure is associated with changes over time in multiple measurements that may be collected using the non-invasive systems, devices, and methods disclosed herein. In particular, worsening heart failure is associated with increased amplitude of the S3 heart sounds, faster and shallower breathing at rest, reduced relative tidal volume (lung volume representing the amount of air displaced between inspiration and expiration at rest), and reduced thoracic impedance.

Fig. 1 depicts a typical environment 100 in which an illustrative embodiment of an example system 102 may be employed for non-invasively detecting and monitoring a medical or health condition (e.g., chronic disease, including CHF) of a human subject using a variety of sensing modalities, in accordance with some embodiments of the present disclosure. As shown in fig. 1, the system 102 includes a plurality of multi-modal sensing and measurement modules 112 (see also fig. 2), and a plurality of surface electrodes/sensors 114a-114d (e.g., four (4) surface electrodes/sensors, or any other suitable number of surface electrodes/sensors). For example, one or more surface electrodes may be implemented as solid gel surface electrodes, or any other suitable surface electrode. Furthermore, the one or more sensors may be implemented as heart sound sensors, ultrasound sensors, photoplethysmography (PPG) sensors, or any other suitable sensor. The system 102 may be configured as a generally triangular device, or any other suitably shaped device, operable to contact one or more of the torso, upper chest, and neck regions of the human subject 104, or any other suitable portion or region of the body, via at least a plurality of surface electrodes/sensors 114a-114 d.

In various embodiments, the system 102 may have a configuration that allows it to be implemented within a wearable vest-like structure, as a plurality of patch-like devices, or any other suitable structure or device. Various examples of device configurations are shown in fig. 4A-4C, fig. 5-8, fig. 10, fig. 14-18, and fig. 25.

In the exemplary environment 100, the system 102 is operable to bi-directionally communicate with the smart phone 106 via a wireless communication path 116, and the smart phone 106 is in turn operable to bi-directionally communicate with a communication network 108 (e.g., the Internet) via a wireless communication path 118. The smart phone 106 also operates through the communication network 108 to bi-directionally communicate with the cloud 110 over the wireless communication path 120, and the cloud 110 may include resources, data storage, and/or other functionality for cloud computing, data processing, data analysis, data trend, data reduction, data fusion. The system 102 is also operable to bi-directionally communicate directly with the cloud 110 via the wireless communication path 122.

Fig. 2 depicts a detailed view of a system 102 for non-invasively detecting and monitoring a medical or health condition (e.g., chronic diseases, including CHF, COPD, other heart diseases, and/or other pulmonary diseases) of a human subject in accordance with some embodiments of the present disclosure. As shown in fig. 2, the system 102 includes a plurality of multi-modality sensing and measurement modules 112, a processor 202 and its associated memory 208, a data store 206 for storing multi-modality sensing data, and a transmitter/receiver 204. The transmitter/receiver 204 may be configured to perform bluetooth communications, wiFi communications, or any other suitable short-range communications to communicate with the smart phone 106 (see fig. 1) over the wireless communication path 116. The transmitter/receiver 204 may also be configured to perform cellular communications or any other suitable remote communications to communicate with the cloud 110 (see fig. 1) over the wireless communication path 122.

In some embodiments, the plurality of multi-modal sensing and measurement modules 112 may include, but are not limited to, one or more chest impedance measurement modules 212, an Electrocardiogram (ECG) measurement module 214, a respiratory rate measurement module 216, and a tidal volume measurement module 218, a heart sound based measurement module 220, a pulse oximetry module 222. In one embodiment, the system 102 may be configured to perform a reflected pulse oximetry measurement. In other embodiments, the system 102 may include a finger set device (not shown) for performing finger-based pulse oximetry measurements. The plurality of multi-modal sensing and measurement modules 112 further include electrode/sensor connection switching circuitry 224 for switchably connecting with the plurality of surface electrodes/sensors 114a-114d shown in fig. 1.

The processor 202 may include a plurality of processing modules, such as a data analyzer 226 and a data fusion/decision engine 228. The transmitter/receiver 204 may include at least one antenna 210 for transmitting/receiving wireless signals, such as bluetooth or WiFi signals, to/from the smart phone 106 via the wireless communication path 116, and the smart phone 106 may be a bluetooth or WiFi enabled smart phone or any other suitable smart phone. Antenna 210 is also used to transmit/receive wireless signals, such as cellular signals, to/from cloud 110 via wireless communication path 122.

The operation of system 102 for non-invasively detecting and monitoring medical or health conditions, such as chronic diseases (including CHF, COPD, other cardiac conditions, and/or other pulmonary conditions) in a human subject, using a variety of sensing modalities, will be further understood with reference to the following illustrative examples and fig. 1 and 2. In this illustrative example, at a fixed time of day for a predetermined number of days (e.g., twice a day) when the human subject 104 is in a supine or upright position, the human subject 104 (see fig. 1) or the human assistant positioning system 102 is configured as a generally triangular device (or any other suitably shaped device) such that it is in contact with one or more of the torso and upper chest and neck regions (or any other suitable body part or region) of the subject via the plurality of surface electrodes/sensors 114a-114 d.

Upon positioning the system 102 in contact with the torso and/or upper chest and/or neck regions of the human subject, the plurality of multi-modal sensing and measurement modules 112 may be activated to collect, sense, measure, or otherwise obtain multi-modal sensed data from the human subject 104. For example, the thoracic impedance measurement module 212 may perform thoracic impedance sensing using a plurality of vectors to obtain measurements of the thoracic fluid impedance of a human subject and to obtain trends in pulmonary fluid hyperemia localization. To this end, the thoracic impedance measurement module 212 may apply a suitable high frequency, low amplitude current between two or more surface electrodes 114a-114d via an electrode/sensor connection switching circuit 224. In one example, the current is applied between two of the electrodes 114a-114d of the neck and chest of the human subject, e.g., via the surface electrode pair 114a, 114 b. The thoracic impedance measurement module 212 obtains a thoracic impedance signal by measuring the potential difference between the two surface electrodes 114a-114d through the electrode/sensor connection switching circuit 224. In some examples, the high frequency, low amplitude current applied between surface electrodes 114a-114d has a frequency between about 50 kilohertz (kHz) and about 100kHz and has an amplitude between about 1 milliamp root mean square (mArms) and 4 mArms. In other examples, the current has a frequency below about 50kHz or above about 100 kHz. In some examples, the current has a frequency between about 20kHz and about 200kHz, or between about 20kHz and about 1 megahertz (MHz).

In some embodiments, the thoracic impedance measurement module 212 uses measurements obtained from two pairs of surface electrodes. In one embodiment, four electrodes are used for impedance measurement. The four electrodes include two force electrodes and two sense electrodes, one paired with each force electrode. Each set of four electrodes can resolve the vectors in space to locate the observed changes. Each side of the vector has two of the four electrodes. In particular, there may be one force electrode and one sense electrode on each side of the vector. The force electrodes apply (or inject) current to (or receive current injected into) the body. The sensing electrode measures the disturbance caused by the current applied by the force electrode into the body. In various embodiments, the vector sense electrode senses the current and/or voltage drop caused by the force electrode injecting current into the body by applying a voltage and/or current. Since the voltage and current are related to the impedance (v=z×i), in order to measure the impedance Z, a known current i may be applied, then the subsequent voltage drop V may be measured, and Z may be calculated using the known current i and the measured voltage V variation. According to various embodiments, the characteristics of the circuit for applying a current (force electrode) are different from the characteristics of the circuit for measuring a voltage (sense electrode). According to various embodiments, there are two different sets of electrodes (force and sense electrodes), and each electrode has a positive side and a negative side.

Using four electrodes, tissue and tissue of different depths can be scanned by adjusting the frequency of the injection waveform. The impedance is measured on a single vector without spatial resolution. In some embodiments, more than four electrodes are used, and additional pairs of electrodes add multiple vectors, which adds additional tissue scans. In some embodiments, each pair of sense and force electrodes is one side of a plurality of vectors. For example, two pairs of inductive force electrodes constitute one vector, and three pairs of inductive force electrodes constitute three vectors. In other examples, more pairs of electrodes are used and more vectors are formed. Thus, each vector monitors a selected spatial region.

In other embodiments, each electrode 114a-114d may operate as a force electrode or a sense electrode depending on the electrode/sensor connection switching circuit 224. Further, the force electrodes may be configured by the electrode/sensor connection switching circuit 224 to control the voltage or current applied by the force electrodes, and the sense electrodes may measure the current or voltage, respectively. Based on the applied voltage or current and the measured current or voltage, the system 102 may derive an impedance, which may be used to determine certain health characteristics of the subject.

The impedance measurements may be used to determine physiological information, including respiratory rate, tidal volume, and lung fluid. Impedance measurements may also be used to determine derived indicators, such as lung resistance and lung fluid location. For respiratory rate, the patient's breath causes air to enter the lungs and increase the lung volume, thereby compressing the surrounding tissue. This can result in impedance changes with the increase in some vectors (primarily those passing through the lungs) and the decrease in other vectors due to the redirection of the current. The respiration rate is determined from the change in impedance, which has the same periodicity as respiration. In addition, tidal volume may be monitored by determining the magnitude of the change in proportion to tidal volume (lung volume change). The shape of the waveform is related to the breathing pattern and can be used to monitor airway/lung resistance.

Fluid in the lungs may be detected and/or monitored by scanning a plurality of frequencies and/or a plurality of spatial vectors that are used to distinguish fluid in the lungs from other body fluids. Another method to increase the specificity of lung fluid and other body fluids separation is to measure the change in impedance with posture. The change in posture may cause the lung fluid to move with gravity. Movement in the fluid can be detected by various vector measurements and helps to separate the moving lung fluid from other body fluids. In one example, the impedance vector is measured at the bottom of the lung using a single frequency of 50 kHz. For example, the impedance vector between electrodes 114c and 114d of FIG. 1 may be measured. If the impedance vector is measured while the person is supine (horizontal position) and then again after the patient has moved to the standard Fowler position, a change in impedance of 1 ohm or more may indicate the presence of fluid in the lungs. In congestive heart failure patients, the impedance changes typically by more than 5 ohms when the patient begins to develop symptoms.

Note that in medicine, the Fowler position is a standard patient position in which the patient is sitting in a semi-upright sitting position with the patient's torso at an angle to the horizontal. In various examples, the position of the fowler includes an angle of the patient's torso between about 15 degrees and 30 degrees, an angle of the patient's torso between about 30 degrees and about 45 degrees, a torso angle of the patient between about 45 degrees and about 60 degrees, and an angle of the patient's torso between about 60 degrees and about 90 degrees. In a standard fowler position, the torso of the patient is between about 45 degrees and about 60 degrees.

In various embodiments, the device includes a sensor that can determine the position of the device, thereby indicating the horizontal position of the patient, including whether the patient is upright or supine. The device automatically measures thoracic impedance of the patient in both the upright and supine positions and uses both measurements to monitor and/or detect chronic disease.

As described above, the apparatus also includes an Electrocardiogram (ECG) measurement module 214 that may perform ECG measurements at some or all of the plurality of surface electrodes 114a-114d contacting the skin of the torso, upper chest and/or neck region of the human subject 104. In one embodiment, the pulse oximetry module 222 (or a finger-worn device for performing finger-based pulse oximetry measurements) may be used in conjunction with the ECG measurement module 214 to obtain further measurements. Because respiratory activity may result in a corresponding change in measured thoracic impedance, each of respiratory rate measurement module 216 and tidal volume measurement module 218 may operate with thoracic impedance measurement module 212 to obtain measurements of respiratory rate/respiratory rate variability and tidal volume, respectively, of a human subject.

The heart sound based measurement module 220 may include an electronic stethoscope, or any other suitable device for obtaining heart rate variability data and obtaining and converting heart sounds (e.g., S1 heart sounds, "lub"; S2 heart sounds, "dub") into sensed data that may then be algorithmically analyzed by the data analyzer 226 to obtain information about S3 heart sounds (also known as raw diastolic or ventricular galloping) (which may be heard during early diastole) and S4 heart sounds (also known as atrial galloping) (which may be heard during late diastole). In one embodiment, the heart sound based measurement module 220 measures sub-aural heart sounds (heart sounds below about 40 Hz), thereby measuring S3 and S4 heart sounds that cannot be heard by a physician or other healthcare professional using a stethoscope. The S3 and S4 heart sounds are pathological, indicating heart failure. There is Guan Ya information of auditory S3 and S4 heart sounds that can be used to detect and monitor chronic diseases. Heart sounds may be measured by sensors placed on the heart area. The sensor detects sound and/or vibration. The sensor detects different heart sounds based on the position of the sensor relative to various regions of the heart. For example, to maximize the chance of detecting the signal associated with S3, the sensor may be positioned above the apex of the heart, which is located in the fifth intercostal space. Abnormal S3 heart sounds occur when heart pumping is impaired. S3 heart sounds are early indicators of heart problems and may change before other measurable heart signals. Since the S3 heart sound has a lot of energy at low frequencies that are not audible to the human ear, the S3 heart sound is initially undetectable by the physician. The addition of an automatic algorithm to the low frequency sensitive sensing system can detect S3 heart sounds earlier. The presence of any S3 or S4 heart sounds in an adult patient is abnormal and any detection of energy determined to be S3 or S4 can be used to mark a potential problem. The markers from the different sensors may be combined by higher level logic to generate a single metric, which may be designed to be more specific and sensitive than the single metric.

In one embodiment, the pulse oximetry module 222 (or a finger-worn device for performing finger-based pulse oximetry measurements) may be used in conjunction with the heart sound-based measurement module 220 to obtain further measurements. Note that the pulse oximetry module 222 may perform a reflective or finger-based pulse oximetry. In one embodiment, the pulse oximetry module 222 may include a pulse rate sensor and an oxygen level (SpO ₂) sensor.

Chest impedance measurements, ECG measurements, respiratory rate and tidal volume measurements, heart rate variability/heart sound based measurements and pulse oximetry measurements, chest impedance measurement module 212, electrocardiogram (ECG) measurement module 214, respiratory rate and tidal volume measurement modules 216, 218, heart sound based measurement module 220 and pulse oximetry module 222 have been performed to provide corresponding multimodal sensing data to data analyzer 226 for at least part of the data analysis, data trend analysis and/or data reduction. In one embodiment, such multi-modal sensed data may also be analyzed, trended, and/or reduced "in the cloud" and made available in the cloud-based data store 110 with preset alerts for various levels of clinical intervention. For example, the data analyzer 226 may (1) analyze chest impedance measurement data to obtain information about pulmonary congestion in a human subject, (2) analyze respiratory rate and tidal volume measurement data to obtain information about respiratory distress (e.g., dyspnea, paroxysmal nocturnal dyspnea) in a human subject, (3) analyze ECG measurement data and heart rate variability data in a plurality of (e.g., 3) projections to obtain information about possible atrial fibrillation and localization in the human subject 104, and (4) analyze heart sound based measurement data to obtain information about possible increases in S3 heart sounds (which may indicate left ventricular failure due to dilated CHF conditions).

The data analyzer 226 provides at least a portion of the analyzed multi-modal sensed data to a data fusion/decision engine 228 that effectively at least partially fuses or combines the multi-modal sensed data in accordance with one or more algorithms and/or decision criteria for subsequent use in making one or more inferences about the chronicity state of the human subject 104. For example, the combined multi-modal sensed data substantially simultaneously shows an S3 heart sound increase, a rapid shallow breath increase when the human subject 104 is in a resting state, a relative tidal volume decrease, and a chest impedance decrease, which may be a strong predictor of potentially problematic chronic diseases in the human subject 104. In one embodiment, such algorithms and/or decision criteria implemented in the data fusion/decision engine 228 may be demonstrated and/or improved by one or more clinical trials to enhance inferences made by the data fusion/decision engine 228 regarding the chronicity of the human subject. The processor 202 then provides at least a portion of the combined multimodal sensing data to the transmitter/receiver 204, which transmits the combined multimodal sensing data either directly to the cloud 110 over the wireless communication path 122 or to the smartphone 106 over the wireless communication path 116. Next, the smartphone 106 may transmit the combined multimodal sensory data over the wireless communication paths 118, 120 to the cloud 110 via the communication network 108, where it may be further analyzed, trended, reduced, and/or fused. The hospital clinician may then remotely download the consolidated multimodal sensing data for monitoring and/or tracking purposes.

Fig. 3 illustrates another example environment 300 in which an example embodiment of an example system 302 for non-invasively detecting and monitoring medical or health conditions may be employed in accordance with some embodiments of the present disclosure. In particular, the system 302 in the illustrated embodiment includes a device 304 for non-invasively detecting a medical or health condition of a subject and a housing 306 for storing the device 304. The box 306 may be referred to as a base station.

In some embodiments, the device 304 may not be capable of wireless communication. In these embodiments, device 304 may rely on a wired connection with housing 306 to communicate with a remote device. For example, when device 304 is located in housing 306, device 304 may establish a wired connection with housing 306, and device 304 and housing 306 may exchange communications via the wired connection. The housing 306 may be in wireless communication with a remote device and may act as an intermediary for communications between the remote device and the device 304. Further details of the device 304 and the housing 306 are described with respect to fig. 7-11.

The environment 300 also includes a cloud 308. Cloud 308 may include one or more features of cloud 110 (fig. 1). Cloud 308 may include one or more servers, including system 302, that provide resources to remote devices. For example, the resources may include computing resources (e.g., processors), storage resources (e.g., memory devices), or some combination thereof, that may be used by the remote device. The resources may include resources for cloud computing, data processing, data analysis, data trending, data reduction, data fusion, data storage, and/or other functions. Further, cloud 308 may be used to share data between remote devices. For example, data stored on cloud 308 may be shared with a medical provider of the subject, allowing the medical provider to monitor health characteristics of the subject captured by device 304. In some embodiments, the medical provider may utilize the data to perform Electrical Imaging Tomography (EIT) and/or impedance spectroscopy to assess health characteristics of the subject.

The environment 300 also includes a communication network 310. Communication network 310 may provide a communication intermediary between system 302 and cloud 308. For example, communication network 310 may include one or more communication components that facilitate and/or manage communication transmissions between cloud 308 and system 302. In some embodiments, the communication network 310 may be further coupled to a remote device and may facilitate and/or manage communication transmissions between the system 302, the cloud 308, and the remote device.

Communication network 310 may provide a wireless connection between system 302 and cloud 308, may provide a wired connection between system 302 and cloud 308, or some combination thereof. In particular, a communication path 312 may be established between the system 302 and the communication network 310, the communication path 312 providing communication transmissions between the system 302 and the communication network 310. Another communication path 314 may be established between the communication network 310 and the cloud 308, the communication path 314 providing communication transport between the communication network 310 and the cloud 308. Communication path 312 and communication path 314 may both be wireless communication paths or may both be wired communication paths, or one may be a wireless communication path and the other may be a wired communication path. For example, in some embodiments, the communication network 310 may comprise a cellular network, and in some embodiments, the communication path 312 may be a wireless cellular communication path. In other embodiments, communication network 310 may include a local area network and housing 306 may be connected to communication network 310 via a wired connection (e.g., an ethernet connection).

In other embodiments in which the apparatus 304 is capable of wireless communication, the apparatus 304 may operate as described with respect to the environment 100 (fig. 1) and with respect to the environment 300. In particular, when device 304 is disconnected from housing 306, device 304 may operate via a wireless connection as described with respect to environment 100. When the device 304 is connected with the housing 306, the device 304 may operate the housing 306 as a middleware, as described with respect to the environment 300. Further, the device 304 may determine, based on the state of the device 304, to operate in accordance with the operations described in connection with the environment 100 or the environment 300. For example, the device 304 may determine that it is in a low power state based on the battery level of the device 304 and select to disable wireless communication of the device 304 to conserve power, thereby limiting the operations described with respect to the environment 300.

In some embodiments, environment 300 may also include a remote device 318. The remote device 318 may include a display and/or user input elements (e.g., a keyboard, a touch screen, one or more buttons, and/or other inputs) for displaying information to a user to receive input from the user. In some embodiments, remote device 318 may include a smart phone, such as smart phone 106 (fig. 1).

A communication path 316 may be established between the device 304 and a remote device 318. Communication path 316 may include a wireless communication path, such as communication via bluetooth communication, wiFi communication, or any other suitable short-range communication. Device 304 and remote device 318 may exchange communications via communications path 316. For example, the device 304 may provide information to the remote device 318 for display to a user on the remote device 318. The information provided via the device 304 may include results of the operation requested by the remote device 318 and/or an indication of an action to be taken in order to perform the operation (e.g., proper placement of the device 304 on the object). The remote device 318 may receive input from a user and utilize the input to alter content displayed on the remote device 318 and/or provide input to the device 304 to cause the device 304 to perform an operation in response to the input. In some embodiments, user authentication may be utilized to establish communication path 316 or to communicate using communication path 316. For example, user authentication may include password verification, biometric identification, and/or device identification. Failure of user authentication may result in failure to establish communication path 316 and/or prevent data from being transmitted over communication path 316.

Fig. 4A is a diagram illustrating an apparatus 400 for detecting and monitoring a health condition of a subject, according to some embodiments of the present disclosure. In particular, the device 400 non-invasively detects and monitors chronic diseases in a human subject. The device 400 comprises a first electrode pair 402a-402b, a second electrode pair 404a-404b, a third electrode 406 and a fourth electrode 408. The first electrode pair 402a-402b includes one force electrode and one sense electrode, as described above. Similarly, the second electrode pair 404a-404b includes one force electrode and one sense electrode. The third 406 and fourth 408 electrodes may be any type of electrode including, for example, one of a heart sound sensor, a force electrode, and a sense electrode. The device 400 has an elongated rectangular base 410 that includes a first electrode pair 402a-402b at a first end and a second electrode pair 404a-404b at a second end. In various examples, the length of the elongate base 410 is between about 10 centimeters (cm) and about 20cm, and between about 2cm and about 6 cm. In some examples, the thickness of the elongate base 410 is between about 1cm and about 4 cm. Along a mid-section of the length of the rectangular base 410, the curved tail 412 extends outwardly in the same plane as the rectangular base 410 and is curved toward the first electrode pair 402a-402 b. The base 410 and the curved tail 412 may comprise the frame of the device 400. The arcuate tail 412 includes a third electrode 406 and a fourth electrode 408. The third electrode 406 is located at the end of the arc-shaped tail 412 and the fourth electrode 408 is located in the middle of the arc-shaped tail 412. According to various embodiments, the apparatus 400 is placed on the torso of a subject with the electrodes 402a-402b, 404a-404b, 406, 408 in contact with the skin of the subject.

Fig. 4B shows an apparatus 400 positioned on a subject's torso. An elongate base 410 is positioned about the sixth intercostal space with a curved tail 412 extending upwardly and curved inwardly toward the torso midline. In some embodiments, the fourth electrode 408 is located in the fifth intercostal space on the left side of the torso and is optimally positioned to detect the S3 sound. In other embodiments, the curved tail 412 curves outwardly away from the midline of the torso. The electrodes are shown in phantom to indicate that the electrodes are located on the opposite side of the device 400 from where the electrodes are shown positioned relative to the skin of the subject.

Fig. 4C shows an apparatus 400 positioned on a subject's torso. An elongate base 410 is located below the shoulder and a curved tail 412 extends downwardly over the heart, curving inwardly toward the midline of the torso. In other embodiments, the curved tail 412 curves outwardly away from the midline of the torso. The electrodes are shown in phantom to indicate that the electrodes are located on the opposite side of the device 400 from where the electrodes are shown positioned relative to the skin of the subject.

Fig. 5 is a diagram illustrating an apparatus 500 for detecting and monitoring a health condition of a subject according to some embodiments of the present disclosure. In particular, the device 500 non-invasively detects and monitors chronic diseases in a human subject. The device 500 includes a first electrode pair 502a-502b, a second electrode pair 504a-504b, and a sensor 506. The first electrode pair 502a-502b includes a force electrode and a sense electrode. Similarly, the second electrode pair 504a-504b includes a force electrode and a sense electrode. In addition, one of the first electrode pairs 502a-502b and one of the second electrode pairs 504a-504b measure ECG. The sensor 506 is a heart sound sensor for detecting sound vibrations. In one embodiment, the sensor 506 is a piezoelectric microphone. The membrane of the microphone protrudes to contact the torso and detect heart sounds. The first electrode pair 502a-502b is connected to the second electrode pair 504a-504b via a first elongated element 508. The second electrode pair 504a-504b is connected to the sensor 506 via a second elongated element 510. The first and second elongated elements 508, 510 may comprise a frame of the device 500. As shown in fig. 5, in the device 500, the first and second elongated elements 508, 510 are substantially perpendicular to each other. In other embodiments, first and second elongated elements 508 and 510 may be oriented in any selected position relative to one another. The device 500 is placed on the torso of a subject with the electrodes 502a-502b and 504a-504b, and the sensor 506 in contact with the skin of the subject. In some embodiments, electrodes 502a-502b and 504a-504b are positioned along the sixth intercostal space and sensor 506 is positioned at the apex of the heart along the fifth intercostal space.

Fig. 6 is a diagram illustrating an apparatus 600 for detecting and monitoring a health condition of a subject according to some embodiments of the present disclosure. The device 600 includes three long flexible arms 608 extending from a rectangular box 610. Rectangular box 610 and flexible arm 608 may comprise a frame of device 600. At the tip of each flexible arm 608 is a pair of electrodes-a first electrode pair 602a-602b, a second electrode pair 604a-604b, and a third electrode pair 606a-606b. The electrode pairs 602a-602b, 604a-604b, 606a-606b may be moved to orient to fit the subject's body and secure in place. The device 600 is a handheld device in which the subject is placed on the body. In some examples, the subject regularly positions the device 600 on the body, for example, two or more times per day, and records the measurements. According to some embodiments, the device 600 comprises a sensor for recording heart sounds. The heart sound sensor may also be connected to the device by a long and flexible arm. The heart sound sensor may be a microphone, and in some examples, it is a piezoelectric microphone.

In other embodiments, the electrodes and/or other sensors are located subcutaneously in the subject. The subcutaneous sensor may remain in place for a long period of time and may be connected to an external device for measurement. In other embodiments, the electrodes and/or other sensors are located within a patch that is attached to the skin of the subject. The patch is connected to an external device for measurement.

Fig. 7 illustrates another example apparatus 700 for detecting and monitoring a health condition of a subject in accordance with some embodiments of the present disclosure. In particular, fig. 7 shows a front side of the device 700 that will be positioned away from the skin of the subject when worn by the subject.

The apparatus 700 may include a frame 702. The components of the device 700 may be mounted to the frame 702 to maintain the position of the components relative to each other. In some embodiments, the frame 702 may have different dimensions, where the different dimensions have different distances between components or arrangements of components to facilitate different body types and/or body sizes of the subject. In other embodiments, the mounting position of the components to the frame 702 may be adjustable to adjust the position of the components for different body types and/or body types of the subject. In some embodiments where the mounting position is adjustable, the ability to adjust the position of the assembly may be limited to a particular individual (e.g., by requiring special tools for adjustment that may not be publicly provided), which may prevent the subject from inadvertently adjusting the mounting position to an incorrect operating position.

The frame 702 may include a body 704 extending in a first direction. Further, the frame 702 may include one or more extensions 706 extending from the body 704 in one or more other directions. For example, in the illustrated embodiment, the frame 702 includes a first extension 706a and a second extension 706b that extend from the body 704. In the illustrated embodiment, the first and second extensions 706a, 706b extend substantially perpendicularly (within 5 degrees) from the main body 704, however, it should be appreciated that the angle may be different in other embodiments. Further, in the illustrated embodiment, the extension 706 is shown secured to the body 704. In other embodiments, the position of the extension 706 along the body 704 may be adjustable.

In some embodiments, the body 704 may include a rigid portion and one or more bending points between the rigid portions. For example, the body 704 includes a flex point 710 (shown in phantom), a first rigid section 712 located on a first side of the flex point 710, and a second rigid section 714 located on a second side of the flex point 710 in the illustrated embodiment. The first rigid portion 712 and the second rigid portion 714 may each comprise a rigid material (e.g., a rigid metal, a rigid plastic, or other rigid material) that retains the rigidity of the rigid portions. In some embodiments, the rigid material may be surrounded by other materials (e.g., fabric) that may more comfortably rest against the subject's skin. The bending point 710 may include a flexible material that allows the first rigid portion 712 and the second rigid portion 714 to bend around the bending point 710. In some embodiments, the flexible material may be the same material (e.g., fabric) surrounding the rigid material and the bend point 710 is characterized by the absence of the rigid material. In other embodiments, the bending point 710 may include a hinge instead of a flexible material. Furthermore, in other embodiments, the entirety of the body 704 may be flexible or rigid. The extension 706 may be rigid or flexible and may be formed of the same material as portions of the body 704 or may be formed of a different material.

The apparatus 700 may also include a reference element 708, which may also be referred to as a guide. The reference element 708 may be coupled to the frame 702 and may be used to properly position the apparatus 700 on the object. In particular, reference element 708 may identify a reference point on the object and may facilitate proper positioning of frame 702 relative to the object. In the illustrated embodiment, the reference element 708 comprises a lanyard or necklace (collectively referred to herein as "lanyards"). The lanyard may utilize the neck of the subject as a reference point for positioning frame 702. In particular, wrapping the lanyard around the neck of the subject may help the subject position frame 702 at a suitable distance from the subject's neck in order to properly position frame 702. In some embodiments, the lanyard may be adjustable or may be of different sizes to facilitate proper positioning of different body types and/or different body types. In other embodiments, reference element 708 may include other means for facilitating positioning frame 702, such as a strap or other marker that references a point on the subject (e.g., one or both arms of the subject, or the sternum of the subject) and indicates where frame 702 should be positioned relative to the point on the subject. Proper positioning of frame 702 may include one or more positioning of surface sensors described throughout this disclosure.

The apparatus 700 may also include a control module 716. Control module 716 may be mounted to frame 702. In the illustrated embodiment, the control module 716 is mounted to the second extension 706b, however, it should be appreciated that in other embodiments, the control module 716 may be mounted to other locations of the frame 702.

The control module 716 may include one or more of the multi-modality sensing and measurement module 112 (fig. 2), the processor 202 (fig. 2), the transmitter/receiver 204 (fig. 2), the data store 206 (fig. 2), the memory 208 (fig. 2), or some combination thereof. The control module 716 may further include a battery for powering the apparatus 700. The control module 716 may be coupled to one or more surface sensors of the apparatus 700, as further described with respect to fig. 8. The control module 716 can control operation of the surface sensor and can store data received from the surface sensor. In some embodiments, control module 716 may store the data and an indication of when the data was captured (e.g., time stamp the data) for future transmission of the data to the cloud (e.g., cloud 110 (fig. 1) and/or cloud 308 (fig. 3)). In other embodiments, control module 716 may also perform operations on data prior to transmitting the data to the cloud. For example, the control module 716 may analyze, trend, reduce, and/or fuse the data, or some portion thereof, prior to transmitting the data to the cloud.

In some embodiments, the control module 716 may also include a direction detection sensor. The direction detection sensor may determine the orientation of the control module 716, which may be used to determine the orientation of the object. For example, the control module 716 may determine whether the subject is standing, lying, or may determine an angle at which the subject is tilted based on the orientation measured by the direction detection sensor. In some embodiments, the direction detection sensor may include an accelerometer that may be used to determine the orientation of the control module 716.

The control module 716 may also include one or more indicators 718. The indicator 718 may indicate a status of the device 700. For example, the indicator 718 may indicate a status of an electronic device of the device 700, an orientation of an object (or indicate that an object transitions to an appropriate orientation to perform an operation of the device 700), a data transfer status, a power status, an operational status, or some combination thereof. The indicators 718 may include visual indicators, audible indicators, motion indicators (e.g., indicators that generate a physical force including vibration), or some combination thereof. In the illustrated embodiment, the indicator 718 includes a light that may illuminate to indicate the status of the device 700. In other embodiments, the indicator 718 may include a light, a display, a speaker, or some combination thereof.

In some embodiments, the indicator 718 may include three different colored lights (e.g., light Emitting Diodes (LEDs)). Depending on the color of the light that is illuminated, whether the light is blinking and/or whether the light is pulsing, different states of the device 700 may be indicated. For example, the first light when illuminated may indicate that the device 700 is connected to a communication network, when flashing the device is ready to connect to a communication network, and/or when pulsed is exchanging data with a communication network. The second light, when illuminated, may indicate that the device 700 is in a pre-read mode and/or is measuring the subject's ECG when blinking. The third light may indicate that the device 700 is fully charged when illuminated, is charging when pulsed, and/or is in a low battery state when blinking. Furthermore, if all three lights flash simultaneously, it may be indicated that one or more electrodes or sensors are not properly applied to the subject. If the three lights flash in sequence, it may indicate that the position of the subject is not suitable for capturing data. Further, the sequence of the three lights flashing in sequence may indicate how the position of the object is incorrect, e.g. indicating that the object should be tilted forward or backward from the current position.

While the shape of frame 702 and the positioning of the components mounted to frame 702 are described with respect to fig. 7, it should be understood that the shape of frame 702 and/or the positioning of the components may be different in other embodiments. In particular, the shape of the frame 702 and the positioning of the components may be any shape or position that enables surface sensor positioning according to one or more of the surface sensor positioning described throughout this disclosure, such as the positioning described with respect to fig. 26A-26G.

Fig. 8 illustrates a back side of the example apparatus 700 of fig. 7, according to some embodiments of the present disclosure. In particular, fig. 8 shows one side of the device 700 that will be positioned towards the skin of a subject when worn by the subject.

The apparatus 700 includes one or more surface sensors mounted to a frame 702. The surface sensor may include one or more features of the surface sensor described throughout this disclosure. The surface sensor may include an electrode, a heart sound sensor, an ultrasonic sensor, a photoplethysmography (PPG) sensor, or some combination thereof. The surface sensor may be arranged to contact the skin surface of the subject when the device 700 is worn by the subject.

The surface sensor may include one or more electrodes 802. For example, the device 700 includes four electrodes in the illustrated embodiment. Electrode 802 may comprise a polished stainless steel electrode, a platinum black electrode, or some combination thereof. The plurality of electrodes 802 may be positioned at a plurality of locations to measure thoracic impedance when the device 700 is worn by a subject. For example, when the device 700 is worn by a subject, the plurality of electrodes 802 may be positioned against the chest of the subject, the neck of the subject, the stomach of the subject, or some combination thereof. In some embodiments, the electrode 802 may be located as shown in FIGS. 26A-26G. In the illustrated embodiment, the device 700 includes a first electrode 802a and a second electrode 802b positioned toward a first end of the body 704, and a third electrode 802c and a fourth electrode 802d positioned toward a second end of the body 704. In other embodiments, the device 700 may have more or fewer electrodes 802, the electrodes 802 may be located in different locations, or some combination thereof.

The electrodes 802 positioned toward the same end of the body 704 may be positioned as close as possible (e.g., by adhesives such as the first adhesive 902 (fig. 9), the second adhesive 904 (fig. 9), and the third adhesive 906 (fig. 9) to make room for proper bonding of the electrodes 802) in view of manufacturing and design considerations. For example, in some embodiments, the distance between electrodes positioned toward the same end may be separated by 0.5cm. Specifically, in some embodiments, the first electrode 802a may be separated from the second electrode 802b by 0.5cm, and the third electrode 802c may be separated from the fourth electrode 802d by 0.5cm. In some embodiments, the distance between electrodes positioned toward the same end may be between 0.3cm and 5cm apart.

Electrodes 802 located at opposite ends of the body 704 may be located a distance to span the lungs of the subject. For example, in some embodiments, the first electrode 802a and the second electrode 802b may be separated from the third electrode 802c and the fourth electrode 802d by between 17cm and 20cm, where 17cm to 20cm may be approximately the width of an adult lung. In some embodiments, the first electrode 802a and the second electrode 802b may be 19cm apart from the third electrode 802c and the fourth electrode 802 d. In other embodiments, the distance between the first and second electrodes 802a, 802b and the third and fourth electrodes 802c, 802d may be adjusted to accommodate objects of different sizes.

Although the electrode 802 is illustrated as circular in the present embodiment, it should be understood that the electrode 802 may be any shape including oval, rectangular, triangular, diamond, or some combination thereof. Further, in some embodiments, the electrodes 802 may comprise segmented electrodes, wherein each electrode 802 may be formed from multiple pieces of material. For example, the illustrated electrode 802 may be split in two halves or quarters. Furthermore, the dimensions of the electrode 802 (or a segment thereof) may be any size suitable for performing measurements, for example having a combined diameter of between 0.5cm and 5 cm.

The surface sensor may also include one or more acoustic sensors. The acoustic sensor may comprise a piezoelectric sensor, an acoustic sensor, or some combination thereof. In the illustrated embodiment, the apparatus 700 includes a sound sensor 804. The sound sensor 804 is located on the first extension 706 a. In other embodiments, the sound sensor 804 may be located at other locations along the frame 702. When the device 700 is worn by a subject, the sound sensor 804 may be positioned against the chest of the subject and close to the heart of the subject. The sound sensor 804 may detect the sound of the subject's heart during operation. The sound sensor 804 may have a curved surface that will be positioned against the skin of the subject, wherein the curvature may provide a greater surface contact with the subject's skin and provide good contact with the skin. Furthermore, the edge 806 of the sound sensor 804 may protrude and the skin of the subject may deform to fill the cavity formed by the protrusion. The protrusion of the edge 806 may help prevent external sounds from affecting the capture of heart sounds captured by the sound sensor 804. In some embodiments, a gel may be applied to the surface of the sound sensor 804 that is to contact the subject's skin, wherein the gel may reduce unintended movement of the sound sensor 804, reduce sound transmission losses that may be caused by air located between the sound sensor 804 and the subject's skin, or some combination thereof.

In some embodiments, edge 806 of acoustic sensor 804 may form an O-ring. In contrast to the edge 806, the portion of the sound sensor 804 inside the edge 806 may be recessed. In some embodiments, the grooves formed in the rim 806 may be filled with gel. The gel may facilitate the transmission of heart sounds to the portion of the sound sensor 804 inside the rim 806. The gel may be implemented as part of the sound sensor 804 (e.g., a solid gel), or may be applied and/or reapplied to the sound sensor 804 prior to application of the device 700 to a subject.

The apparatus 700 may also include one or more temperature sensors. For example, the apparatus 700 includes a temperature sensor 810. The temperature sensor 810 may contact the skin of the subject and may measure the temperature of the skin of the subject. In other embodiments, the temperature sensor 810 may be located near the electrode 802 or may be embedded in the region of one or more pads of the electrode 802. Furthermore, in other embodiments, the apparatus 700 may include additional temperature sensors that measure the temperature of the environment in which the object is located.

In other embodiments, the apparatus 700 may also include additional types of sensors, including any of the types of sensors described throughout this disclosure. For example, in some embodiments, the apparatus 700 may include a pulse oximetry sensor. The pulse oximetry sensor may be located near the electrode 802, near the acoustic sensor 804, near the temperature sensor 810, or at any other location along the frame 702.

The surface sensor may be coupled to the control module 716 and operation of the surface sensor may be controlled by the control module 716. In particular, the surface sensor may be coupled to the control module 716 by an electrical conductor 808 (shown by dashed lines). The electrical conductors 808 may include wires, circuits, or some combination thereof. The electrical conductor 808, or portions thereof, may be flexible. In particular, at least a portion of the electrical conductor 808 extending across the bend point 710 may be flexible and may be designed to bend multiple times without becoming inoperable. The electrical conductors 808 may be located within the frame 702, along the frame 702, or some combination thereof. In embodiments where the bend point 710 comprises a hinge, the electrical conductor 808 may comprise a hinge portion designed to be electrically conductive.

The control module 716 can control operation of the surface sensor and receive surface-sensed data via the electrical conductors 808. For example, the control module 716 may define when the sound sensor 804 captures sound data and may receive and store sound data from the sound sensor 804. Further, the control module 716 may determine which portion of the electrode 802 to apply power (e.g., voltage and/or current) and which portion of the electrode 802 to detect changes (e.g., voltage drops or increases/decreases in current) affected by the application of power. For example, the control module 716 may cause the first electrode 802a and the second electrode 802b to apply power, while the control module 716 causes the third electrode 802c and the fourth electrode 802d to detect the change. A first vector may be formed between the first electrode 802a to which the potential is applied and the third electrode 802c to detect the change. A second vector may be formed between the second electrode 802b to which the potential is applied and the fourth electrode 802d to detect the change. When the apparatus 700 is positioned on a subject, the second vector may be lower on the subject's body than the first vector. In some embodiments, the changes detected by one of the electrodes 802 (e.g., the fourth electrode 802 d) may be used as reference data and may be used to compensate for data captured by the other electrode. In other embodiments, the device 700 may include a particular electrode that may be used as a reference electrode and capture reference data.

In some embodiments, the control module 716 may cause one or more electrodes 802 to apply alternating current as power, and may cause one or more electrodes 802 to detect changes caused by the application of alternating current. For example, the control module 716 may cause the first electrode 802a and the second electrode 802b to apply alternating current, and the control module 716 may cause the third electrode 802c and the fourth electrode 802d to detect the change. The control module 716 may determine an equipotential based on the detected change, wherein the equipotential determined from the third electrode 802c and the fourth electrode 802d may be used to perform EIT. Further, in some embodiments, the control module 716 may vary the frequency of the alternating current. In these embodiments, the detected change may include, in addition to the equipotential, an amount of capacitance and/or resistance between the electrode to which the alternating current is applied and the electrode to which the change is detected. The amount of capacitance and/or resistance may be used in an impedance spectrum to produce an impedance spectrum representation of the path between the electrode to which the alternating current is applied and the electrode to which the change is detected. In addition, when the frequency of the alternating current is changed, EIT may also be performed using equipotential.

Fig. 9 illustrates an example adhesive 900 for maintaining a device for detecting and monitoring a medical or health condition of a subject, according to some embodiments of the disclosure. In particular, the illustrated embodiment shows an adhesive 900 for a device 700 (fig. 7). For clarity, the outline of the device 700 not covered by the adhesive 900 is shown in phantom to illustrate the relationship between the device 700 and the intended location of the adhesive 900.

In the depicted embodiment, the adhesive 900 includes a first adhesive 902, a second adhesive 904, and a third adhesive 906. Adhesive 900 may be a double-sided adhesive, wherein one side of adhesive 900 is for adhering to device 700 and the other side of adhesive 900 is for adhering to the skin of a subject when device 700 is worn by the subject. In some embodiments, adhesive 900 may be disposable, consumable, and/or replaceable. In other embodiments, the adhesive 900 may be reusable.

Adhesive 900 will be positioned near the surface sensor of device 700 and maintain the surface sensor in contact with the subject's skin when the subject wears device 700. For example, the first adhesive 902 will be located near the first electrode 802a (fig. 8) and the second electrode 802b (fig. 8), the second adhesive 904 will be located near the temperature sensor 810 (fig. 8), and the third adhesive 906 will be located near the third electrode 802c (fig. 8), the fourth electrode 802d (fig. 8), and the acoustic sensor 804 (fig. 8). Furthermore, in the illustrated embodiment, adhesive 900 will surround the surface sensor. In particular, the first adhesive 902 can include a first aperture 908, a first electrode 802a extending through the aperture 908 to contact the skin of the subject, and a second aperture 910, a second electrode 802b extending through the aperture 908 to contact the skin of the subject. The second adhesive 904 may include an aperture 912 through which the temperature sensor 810 will extend to contact the skin of the subject. The third adhesive 906 may include a first aperture 914 through which the third electrode 802c extends to contact the skin of the subject, a second aperture 916 through which the fourth electrode 802d extends to contact the skin of the subject, and a third aperture 918 through which the acoustic sensor 804 extends to contact the skin of the subject. The diameter of each aperture may be slightly larger than the diameter of the element extending through the aperture, thereby facilitating easy placement of the element through the aperture. In other embodiments, adhesive 900 may include more or less adhesive than in the illustrated embodiment.

Fig. 10 illustrates another example apparatus 1000 for detecting and monitoring a health condition of a subject in accordance with some embodiments of the present disclosure. In particular, fig. 10 shows one side of the device 1000 that will be positioned towards the skin of a subject when worn by the subject. The apparatus 1000 may include one or more features of the apparatus 700 (fig. 7).

The device 1000 may include one or more electrodes 1002. For example, in the illustrated embodiment, the device 1000 includes five electrodes 1002. In particular, the device 1000 includes a first electrode 1002a, a second electrode 1002b, a third electrode 1002c, and a fourth electrode 1002d. Each of the first electrode 1002a, the second electrode 1002b, the third electrode 1002c, and the fourth electrode 1002d may include one or more features of the first electrode 802a (fig. 8), the second electrode 802b (fig. 8), the third electrode 802c (fig. 8), and the fourth electrode 802d (fig. 8), respectively.

In addition, the device 1000 may include a reference electrode 1002e (which may be referred to as a leg drive electrode). The reference electrode 1002e may be used to set the body of the subject to a certain potential, which may minimize noise detected by the other electrodes 1002. In some embodiments, reference electrode 1002e may be used to detect the potential of the body of the subject, which may be utilized when processing data captured by other electrodes 1002 to compensate for any noise.

In some embodiments, reference electrode 1002e may be smaller than another of electrodes 1002. For example, the reference electrode 1002e may have a diameter of 1cm or less, and the first electrode 1002a, the second electrode 1002b, the third electrode 1002c, and the fourth electrode 1002d may have a diameter of 2cm or more. In other embodiments, the reference electrode 1002e may be the same size as the other electrodes 1002. In addition, the distance between the reference electrode 1002e and the other electrodes 1002 may be 0.5cm or more. For example, in the illustrated embodiment, the reference electrode 1002e may be located 0.5cm or more from the second electrode 1002b.

The device 1000 may also include a sound sensor 1004. The sound sensor 1004 may include one or more features of the sound sensor 804 (fig. 8). The sound sensor 1004 may be configured to be located near the subject's heart and may be used to detect sound produced by the subject's heart. Accordingly, the acoustic sensor 1004 may be located below the first electrode 1002a, the second electrode 1002b, the third electrode 1002c, and the fourth electrode 1002d, and between the electrodes 1002. In particular, in the illustrated embodiment, the acoustic sensor 1004 may be located between 2cm and 10cm below the fourth electrode 1002d, and between 2cm and 10cm to one side of the fourth electrode 1002 d. In some embodiments, the sound sensor 1004 may be configured to be positioned between the midline of the subject and 10cm to one side from the midline of the subject. In other embodiments, the location of the sound sensor 1004 may be limited by space or manufacturability. In other embodiments, the acoustic sensor 1004 may be located in a different position relative to the electrode 1002 while still being configured to be located near the subject's heart.

Fig. 11 illustrates an example system 1100 for non-invasively detecting and monitoring medical or health conditions in accordance with some embodiments of the disclosure. System 1100 may be implemented as system 302 (fig. 3) in environment 300 (fig. 3). In particular, system 1100 can include device 1102 and housing 1104. The housing 1104 may be referred to as a base station. In the illustrated environment, apparatus 1102 is shown as apparatus 700 (fig. 7). In other embodiments, device 1102 may comprise any of the devices described herein, including device 400 (fig. 4A), device 500 (fig. 5), device 600 (fig. 6), device 700, device 1000 (fig. 10), or device 2500 (fig. 25). The device 1102 and the housing 1104 may include one or more features of the device 304 (fig. 3) and the shell 306 (fig. 3), respectively.

The housing 1104 may house the device 1102 and may be used to store the device 1102. In the illustrated embodiment, the housing 1104 may include a contoured portion 1106, and the device 1102 may be housed within the contoured portion 1106. Contoured portion 1106 may be of a similar shape to device 1102 or device 1102 when device 1102 is in a collapsed state (as shown). In other embodiments, the contoured portion 1106 may be omitted or may be formed as part of the receiving device 1102.

In the depicted embodiment, the housing 1104 is shown having a bottom member 1108 and a top member 1110 connected by a hinge 1112. Hinge 1112 may allow bottom member 1108 and top member 1110 to rotate to open and close housing 1104. For example, the housing 1104 may be closed with the device 1102 within the contoured portion 1106 of the housing 1104 to protect the device 1102 from damage when not in use. It should be understood that the housing 1104 described and illustrated is but one example of a housing that may be implemented within the system 1100. In other embodiments, the housing 1104 may include a single piece upon which the device 1102 may rest. In some embodiments, the housing 1104 may be sized to fit on a bedside table.

The housing 1104 may include electronics for transmitting and storing data from the device 1102. For example, the housing 1104 may include electronics for transmitting and storing data received from the device 1102. For example, the housing 1104 may include a transmitter/receiver (e.g., transceiver/receiver 204), a data store (e.g., data store 206), a memory device (e.g., memory 208), or some combination thereof. In particular, the transmitter/receiver may be used to transmit communications between the device 1102 and the housing 1104, between the housing 1104 and a communication network, such as the communication network 310 (fig. 3), or some combination thereof. The transmitter/receiver may provide wired communication, wireless communication, or some combination thereof. For example, the transmitter/receiver may provide bluetooth communications, wiFi communications, other suitable short-range communications, cellular communications, or other suitable long-range communications, or some combination thereof. In some embodiments, the transmitter/receiver may provide wired communication with the device 1102, and may provide wired communication or wireless communication with a communication network.

The housing 1104 may include electronics for processing data and/or communications. For example, the housing 1104 may include a processor (e.g., the processor 202 (fig. 2)). The processor may perform one or more operations of the data analyzer 226 (fig. 2) and/or the data fusion/decision engine 228 (fig. 2). For example, the processor may analyze, trend, reduce, and/or fuse data received from the device 1102 or some portion thereof. In other embodiments, the device 1102 may perform one or more operations of the data analyzer 226 and/or the data fusion/decision engine 228, both the device 1102 and the housing 1104 may perform one or more operations of the data analyzer 226 and/or the data fusion/decision engine 228, the device 1102 may perform some operations of the data analyzer 226 and/or the data fusion/decision engine 228, or neither the device 1102 nor the housing 1104 may perform operations of the data analyzer 226 and/or the data fusion/decision engine 228. In some embodiments, the processor and/or device 1102 may perform data compression in addition to or in lieu of the operation of the data analyzer 226 and/or the data fusion/decision engine 228. Further, the device 1102, the housing 1104, or both, may process and/or format data into a format that may be readily used for EIT and/or impedance spectroscopy. In embodiments where operations are performed, the operations may be performed using data received from the device 1102 before the data is transmitted to a communication network.

The housing 1104 may also include electronics for charging the device 1102. For example, the housing 1104 may be connected to a power source (e.g., mains) and may include a charging circuit capable of charging the device 1102 from the power source when the device 1102 is connected to the housing 1104.

The housing 1104 may also include a connector for connection with the device 1102. For example, in the illustrated embodiment, the housing 1104 includes a pin 1114. Pins 1114 couple with the electronics of housing 1104 and may couple device 1102 with the electronics of housing 1104 when device 1102 is connected to housing 1104. Pins 1114 may facilitate data transfer between device 1102 and housing 1104, as well as charging of device 1102, when device 1102 is connected to housing 1104. Pins 1114 may extend into profile portion 1106 such that device 1102 may be connected to pins 1114 when device 1102 is positioned within profile portion 1106 of housing 1104. In other embodiments, the connector may include a header (e.g., a USB port and/or a serial port), a cable (e.g., a USB cable or another computer cable), or some combination thereof.

The device 1102 is shown as showing the bottom of the device 1102, wherein the device 1102 is in a folded state. For example, a portion of the device 1102 may be folded about a bending point (e.g., bending point 710 (fig. 7)) to place the device 1102 within the housing 1104. The apparatus 1102 may further include a control module 1116, which may include one or more features of the control module 716 (fig. 7). The control module 1116 may include a connector that mates with a connector of the housing 1104. For example, the control module 1116 includes a socket 1118 that mates with a pin 1114 of the housing 1104. The device 1102 is connected to the housing 1104 when the connector of the control module 1116 mates with the connector of the housing 1104. When the device 1102 is connected to the housing 1104, the housing 1104 can charge the device 1102 and can exchange communications (e.g., data) between the device 1102 and the housing 1104. Once the housing 1104 receives data from the device 1102, the data can be transferred by the housing 1104 to a communication network.

Fig. 12 illustrates another example system 1200 for non-invasively detecting and monitoring medical or health conditions in accordance with some embodiments of the disclosure. System 1200 may include one or more features of system 1100 (fig. 11).

The system 1200 may include a device 1202. In the depicted environment, apparatus 1202 is shown as apparatus 700 (FIG. 7). In other embodiments, apparatus 1202 may comprise any of the apparatuses described herein, including apparatus 400 (fig. 4A), apparatus 500 (fig. 5), apparatus 600 (fig. 6), apparatus 700, apparatus 1000 (fig. 10), or apparatus 2500 (fig. 25).

The system 1200 can also include a base station 1204. Base station 1204 may include one or more features of housing 1104 (fig. 11). In particular, base station 1204 may be configured to store, charge, and/or transmit data with apparatus 1202. For example, the apparatus 1202 may be hung on the base station 1204 for storage by a reference element of the apparatus, such as reference element 708 (fig. 7). In particular embodiments, the reference element may be a lanyard or necklace that extends around a portion of base station 1204 and hangs device 1202 from base station 1204. Base station 1204 may also include one or more wires to couple to apparatus 1202 for charging and/or transmitting data with apparatus 1202, may include wireless circuitry for wirelessly charging and/or transmitting data with apparatus 1202, or some combination thereof.

Fig. 13 illustrates another example base station 1300 in accordance with some embodiments of the present disclosure. Base station 1300 may include one or more features of a housing 1104 (fig. 11). Base station 1300 may include a housing having a lower portion 1302 and an upper portion 1304. The lower portion 1302 may be similar to the bottom section 1108 of the housing 1104 (fig. 11) and may be used to store, charge, and transmit data with the device.

The upper portion 1304 can be used to renew and/or replace the adhesive of the device (e.g., the first adhesive 902 (fig. 9), the second adhesive 904 (fig. 9), and the third adhesive 906 (fig. 9)). In particular, the upper portion 1304 may include a tray having a groove 1306 for receiving a device and one or more adhesive grooves 1308 for receiving adhesive.

An adhesive groove 1308 may extend from the groove 1306 into the upper portion 1304. The adhesive groove 1308 can receive adhesive and, when the device is placed within the groove 1306, the adhesive can adhere to the device in place. In particular, a user may place adhesive in adhesive groove 1308, remove the protective cover to cover the adhesive portion, and then remove the protective cover away from upper portion 1304 to expose the adhesive portion. When a device is placed in the groove 1306, the exposed adhesive portion may contact the device and adhere the adhesive to the device in place.

In some embodiments, different adhesives may bond at different times. For example, in the illustrated embodiment, the device may be wider than the base station 1300 when the device is deployed. To facilitate proper placement of the adhesive, the first portion of adhesive may be applied at one time and the second portion of adhesive may be applied at a different time. In the illustrated embodiment, a first adhesive 902 may be placed in the first adhesive pocket 1308a and a second adhesive 904 may be placed in the second adhesive pocket 1308 b. A portion of the device can then be placed in the groove 1306 with the control module 716 positioned adjacent to the second adhesive groove 1308b, and the first electrode 802a and the second electrode 802b positioned adjacent to the first adhesive groove 1308 a. When the portion of the device is placed in the groove 1306, the first adhesive 902 and the second adhesive 904 may adhere to the device. Separately, a third adhesive 906 may be placed in the third adhesive pocket 1308 c. Another portion of the device may be placed in the groove 1306 with the third electrode 802c, the fourth electrode 802d, and the acoustic sensor 804 positioned adjacent to the third adhesive groove 1308 c. When a portion of a device is placed in the groove 1306, the third adhesive 906 may become adhered to the device.

Fig. 14 illustrates another example apparatus 1400 for detecting and monitoring a health condition of a subject in accordance with some embodiments of the present disclosure. In particular, fig. 14 shows the front side of the device 1400, which will be positioned away from the skin of the subject when worn by the subject.

The device 1400 may include a frame 1402. The components of the device 1400 may be mounted to a frame 1402 to maintain the position of the components relative to each other. In some embodiments, the frame 1402 may have different dimensions, with the different dimensions having different distances between components or arrangements of components to facilitate different body types and/or body sizes of the subject. In other embodiments, the mounting position of the components to the frame 1402 may be adjustable to adjust the position of the components for different body sizes and/or body shapes of the subject. In some embodiments where the mounting position is adjustable, the ability to adjust the position of the assembly may be limited to a particular individual (e.g., by requiring special tools for adjustment that may not be publicly provided), which may prevent the subject from inadvertently adjusting the mounting position to an incorrect operating position.

The frame 1402 may include a body 1404. The body 1404 may extend in a first direction and may be curved. In other embodiments, the body 1404 may be straight. Further, the frame 1402 may include one or more extensions 1406 that extend from the body in one or more other directions. For example, the body 1404 includes a first extension 1406a and a second extension 1406b that are coupled to the body 1404 and extend from the body 1404 in the illustrated embodiment. The first extension 1406a may be connected to the body 1404 at a first end of the body 1404 and the second extension 1406b may be connected at a second end of the body 1404 opposite the first end. In the illustrated embodiment, the first and second extensions 1406a, 1406b extend substantially perpendicularly (within 5 degrees) from the body 1404, however it should be understood that the angles may be different in other embodiments. Further, in the illustrated embodiment, the extension 1406 is shown secured to the body 1404. In other embodiments, the position of extension 1406 along body 1404 may be adjustable.

In some embodiments, the body 1404 may include a rigid portion and one or more bending points between the rigid portions. For example, body 1404 includes a flex point 1410 (shown in phantom), a first rigid section 1412 located on a first side of flex point 1410, and a second rigid section 1414 located on a second side of flex point 1410. The first and second rigid portions 1412, 1414 may each include a rigid material (e.g., rigid metal, rigid plastic, or other rigid material) that retains the rigidity of the rigid portions. In some embodiments, the rigid material may be surrounded by other materials (e.g., fabric) that may more comfortably rest against the subject's skin. The bending point 1410 may include a flexible material that allows the first rigid portion 1412 and the second rigid portion 1414 to bend around the bending point 1410. In some embodiments, the flexible material may be the same material (e.g., fabric) surrounding the rigid material and the bending points 1410 are characterized by the absence of the rigid material. In other embodiments, the bending points 1410 may include hinges instead of flexible materials. Moreover, in other embodiments, the entirety of the body 1404 may be flexible or rigid. Extension 1406 may be rigid or flexible and may be formed of the same material as portions of body 1404 or may be formed of a different material.

The apparatus 1400 may also include a control module 1416. The control module 1416 may be mounted to the frame 1402. In the illustrated embodiment, the control module 1416 is mounted to the first extension 1406a, however, it should be appreciated that the control module 1416 may be mounted to other locations of the frame 1402 in other embodiments.

The control module 1416 may include one or more of the multi-modality sensing and measurement module 112 (fig. 2), the processor 202 (fig. 2), the transmitter/receiver 204 (fig. 2), the data storage 206 (fig. 2), the memory 208 (fig. 2), or some combination thereof. The control module 1416 may also include a battery for powering the device 1400. The control module 1416 may be coupled to one or more surface sensors of the apparatus 1400, as further described with respect to fig. 15. The control module 1416 may control the operation of the surface sensors and may store data received from the surface sensors. In some embodiments, control module 1416 may store the data and an indication of when the data was captured (e.g., timestamp the data) for future transmission of the data to the cloud (e.g., cloud 110 (fig. 1) and/or cloud 308 (fig. 3)). In other embodiments, the control module 1416 may also perform operations on the data prior to transmitting the data to the cloud. For example, the control module 1416 may analyze, trend, reduce, and/or fuse the data or some portion thereof prior to transmitting the data to the cloud.

In some implementations, the control module 1416 can also include a direction detection sensor. The direction detection sensor may determine the orientation of the control module 1416, which may be used to determine the direction of the object. For example, the control module 1416 may determine that the subject is standing, lying, or may determine an angle at which the subject is tilted based on the orientation measured by the direction detection sensor. In some embodiments, the direction detection sensor may include an accelerometer that may be used to determine the orientation of the control module 1416.

The control module 1416 may also include one or more switches 1418. The switch 1418 may include a button, a slide switch, a throw switch, a toggle switch, a rotary switch, or some combination thereof. In the illustrated embodiment, the switch 1418 includes a button. Actuation of the switch 1418 may be detected by the control module 1416 and may cause a process (e.g., the method 2400 (fig. 24)) to be initiated. In some embodiments, the procedure initiated in response to actuation of switch 1418 may depend on the amount of time switch 1418 is actuated. For example, a switch 1418 actuated beyond a threshold period of time may cause the current procedure to be paused or the procedure may be restarted.

While the shape of the frame 1402 and the positioning of the components mounted to the frame 1402 are described with respect to fig. 14, it should be understood that the shape of the frame 1402 and/or the positioning of the components may be different in other embodiments. In particular, the shape of the frame 1402 and the positioning of the components may be any shape or position that enables surface sensor positioning according to one or more of the surface sensor positioning described throughout this disclosure, such as the positioning described with respect to fig. 26A-26G.

Fig. 15 illustrates a back side of the example apparatus 1400 of fig. 14, according to some embodiments of the present disclosure. In particular, fig. 15 shows a side of the device 1400 that will be positioned towards the skin of a subject when worn by the subject.

The device 1400 includes one or more surface sensors mounted to a frame 1402. The surface sensor may include one or more features of the surface sensor described throughout this disclosure. The surface sensor includes an electrode, a heart sound sensor, an ultrasonic sensor, a PPG sensor, or some combination thereof. The surface sensor may be arranged to contact the skin surface of the subject when the device 1400 is worn by the subject.

The surface sensor may include one or more electrodes 1502. For example, in the illustrated embodiment, the device 1400 includes four electrodes. The electrode 1502 may comprise a polished stainless steel electrode, a platinum black electrode, or some combination thereof. The plurality of electrodes 1502 may be positioned at a plurality of locations to measure thoracic impedance while the device 1400 is being worn by the subject. For example, when the device 1400 is worn by a subject, the plurality of electrodes 1502 may be positioned against the chest of the subject, the neck of the subject, the stomach of the subject, or some combination thereof. In some embodiments, electrode 1502 may be positioned as shown in FIGS. 26A-26G. In the illustrated embodiment, the device 1400 includes a first electrode 1502a and a second electrode 1502b positioned toward a first end of the body 1404, and a third electrode 1502c and a fourth electrode 1502d positioned toward a second end of the body 1404. In other embodiments, the device 1400 may have more or fewer electrodes, the electrodes may be located in different locations, or some combination thereof.

The electrodes 1502 positioned toward the same end of the body 1404 may be positioned as close as possible in view of manufacturing and design considerations (e.g., space to allow for proper adhesion of the electrodes by adhesive). For example, in some embodiments, the distance between electrodes 1502 positioned toward the same end may be separated by 0.5cm. In particular, the first electrode 1502a may be separated from the second electrode 1502b by 0.5cm, and the third electrode 1502c may be separated from the fourth electrode 1502d by 0.5cm. In some embodiments, the distance between electrodes positioned toward the same end may be between 0.3cm and 5cm apart.

Electrodes 1502 at opposite ends of body 1404 may be positioned a distance to span the lungs of the subject. For example, in some embodiments, the first electrode 1502a and the second electrode 1502b may be separated from the third electrode 1502c and the fourth electrode 1502d by between 17cm and 20cm, where between 17cm and 20cm may be approximately one width of an adult human lung. In some embodiments, the first electrode 1502a and the second electrode 1502b may be 19cm apart from the third electrodes 1502c and 1502 d. In other embodiments, the distance between the first and second electrodes 1502a, 1502b and the third and fourth electrodes 1502c, 1502d may be adjusted to accommodate objects of different sizes.

Although the electrode 1502 is shown as being generally elliptical in this embodiment, it should be understood that the electrode may be any shape including circular, rectangular, triangular, diamond-shaped, or some combination thereof. Further, in some embodiments, the electrodes 1502 may comprise segmented electrodes, wherein each electrode 1502 may be formed from multiple pieces of material. For example, the illustrated electrode 1502 may be split in two halves or four halves. Further, the dimensions of the electrode 1502 (or a segment thereof) may be any size suitable for performing measurements, for example having a surface area between 0.9 square centimeters (cm 2) and 19.7cm ².

The surface sensor may also include one or more acoustic sensors. The acoustic sensor may comprise a piezoelectric sensor, an acoustic sensor, or a combination thereof. In the depicted embodiment, the apparatus 1400 includes a sound sensor 1504. The sound sensor 1504 is located on the first extension 1406 a. In other embodiments, the sound sensor 1504 may be located at other locations along the frame 1402. When the device 1400 is worn by a subject, the sound sensor 1504 may be placed at the chest of the subject and close to the heart of the subject. The sound sensor 1504 may detect the sound of the subject's heart during operation. The sound sensor 1504 may have a curved surface to be positioned against the skin of the subject, wherein the curvature may provide a greater surface contact with the skin of the subject and provide good contact with the skin. Further, the edge 1506 of the sound sensor 1504 may protrude and the skin of the subject may deform to fill the cavity formed by the protrusion. The protrusion of the edge 1506 may help prevent external sounds from affecting the capture of heart sounds captured by the sound sensor 1504. In some embodiments, a gel may be applied to a surface of the sound sensor 1504 that will contact the subject's skin, wherein the gel may reduce unintended movement of the sound sensor 1504, reduce sound transmission losses that may be caused by air located between the sound sensor 1504 and the subject's skin, or some combination thereof.

The surface sensors may include combination sensors 1508. The combination sensor 1508 can include a reference electrode (e.g., reference electrode 1002e (fig. 10)) and a temperature sensor (e.g., temperature sensor 810 (fig. 8)). The reference electrode of the combination sensor 1508 can be used to set the body of the subject to a particular potential, which can minimize noise detected by the other electrodes 1502. In some embodiments, a reference electrode may be used to detect the potential of the subject's body, which may be used when processing data captured by the other electrodes 1502 to compensate for any noise.

In some embodiments, the combined sensor 1508 may be smaller than the other electrodes. For example, the combined sensor 1508 may have a surface area of 3.1416cm ², and the first, second, third, and fourth electrodes 1502a, 1502b, 1502c, 1502d may have a surface area of 12.5664cm ² or greater. In other embodiments, the combined sensor 1508 may have the same dimensions as the other electrodes 1502. Further, the distance between the combination sensor 1508 and the other electrode 1502 may be 0.5cm or more. For example, in the illustrated embodiment, the combined sensor 1508 may be located 0.5cm or greater from the third electrode 1502 c.

The temperature sensor of the combination sensor 1508 may contact the skin of the subject and may measure the temperature of the skin of the subject. In other embodiments, the temperature sensor may be located near the electrode or may be embedded in the region of one or more pads of the electrode. Furthermore, in other embodiments, the apparatus 1400 may include additional temperature sensors that measure the temperature of the environment in which the object is located.

In other embodiments, the device 1400 may also include additional types of sensors, including any of the types of sensors described throughout this disclosure. For example, in some embodiments, the device 1400 may include a pulse oximetry sensor. The pulse oximetry sensor may be located near the electrode 1502, near the combination sensor 1508, or at any other location along the frame 1402.

The surface sensor may be coupled to the control module 1416 (fig. 14) and operation of the surface sensor may be controlled by the control module 1416. In particular, the surface sensor may be coupled to the control module 1416 via an electrical conductor, such as electrical conductor 808 (fig. 8). The electrical conductors may include wires, electrical circuits, or some combination thereof. The electrical conductor or portions thereof may be flexible. In particular, at least a portion of the electrical conductor extending across the bend point 1410 (fig. 14) may be flexible and may be designed to bend multiple times without becoming inoperable. The electrical conductors may be located within the frame 1402, along the frame 1402, or some combination thereof. In embodiments where the bend point 1410 includes a hinge, the electrical conductor may include a hinge portion designed to be electrically conductive.

The control module 1416 may control the operation of the surface sensors and receive data of the surface sensors via the electrical conductors. For example, the control module 1416 may define when the sound sensor 1504 captures sound data and may receive and store sound data from the sound sensor 1504. Further, the control module 1416 can determine which portion of the electrode 1502 will apply power (e.g., voltage and/or current) and which portion of the electrode will detect changes (e.g., voltage drops or increases/decreases in current) that are affected by the applied power. For example, the control module 1416 can cause the first electrode 1502a and the second electrode 1502b to apply power, while the control module 1416 causes the third electrode 1502c and the fourth electrode 1502d to detect the change. In some embodiments, the changes detected by one of the electrodes (e.g., the reference electrode of the combination sensor 1508) can be used as reference data and can be used to compensate for data captured by the other electrode. In other embodiments, the device 1400 may include a specific electrode that can be used as a reference electrode and capture reference data.

In some embodiments, the control module 1416 may cause one or more electrodes to apply alternating current as power and may cause one or more electrodes to detect changes caused by the application of alternating current. For example, the control module 1416 can cause the first electrode 1502a and the second electrode 1502b to apply alternating current, and the control module 1416 causes the third electrode 1502c and the fourth electrode 1502d to detect the change. The control module 1416 may determine an equipotential based on the detected change, wherein the equipotential determined from the third electrode 1502c and the fourth electrode 1502d may be used to perform EIT. Further, in some embodiments, the control module 1416 may vary the frequency of the alternating current. In these embodiments, the detected change may include, in addition to the equipotential, an amount of capacitance and/or resistance between the electrode to which the alternating current is applied and the electrode to which the change is detected. The amount of capacitance and/or resistance may be used in an impedance spectrum to produce an impedance spectrum representation of the path between the electrode to which the alternating current is applied and the electrode to which the change is detected. In addition, when the frequency of the alternating current is changed, EIT may also be performed using equipotential.

Fig. 16 illustrates another example apparatus 1600 for detecting and monitoring a health condition of a subject in accordance with some embodiments of the present disclosure. The apparatus 1600 may include one or more features of the apparatus 1400 (fig. 14). Fig. 16 shows the front side of the device 1600 that will be positioned away from the skin of the subject when worn by the user.

The device 1600 may include a frame 1602. The frame 1602 may include one or more features of the frame 1402 (fig. 14). For example, components of the device 1600 may be mounted to the frame 1602 to maintain the position of the components relative to each other. The frame 1602 may include a body 1604, the body 1604 having a first extension 1606 and a second extension 1608 extending from the body 1604. In the illustrated embodiment, the body 1604 includes a bend 1610 that extends a first portion of the frame 1602 in a first direction and a second portion of the frame 1602 in a second direction. The first and second extensions 1606, 1608 may extend from the body 1604 in a third direction, where the third direction is different from the first and second directions.

The device 1600 may further include a holder 1612. The device 1600 may be flexible and/or have a bend point that allows one portion of the body 1604 to fold over another portion of the body 1604. The retainer 1612 may interact with portions of the body 1604 and retain the device 1600 in a folded arrangement. For example, the retainer 1612 may be in frictional contact with a portion of the body 1604 to hold the device 1600 in a folded arrangement.

The device 1600 may include a control module 1614 mounted to the first extension 1606. The control module 1614 may include one or more features of the control module 1416 (fig. 14). In addition, the first extension 1606 may include islands 1616. The island 1616 may be used to mount a sound sensor as further described with respect to fig. 17.

Fig. 17 illustrates a back side of the example apparatus 1600 of fig. 16, according to some embodiments of the present disclosure. In particular, fig. 17 shows a side of the device 1600 that will be positioned towards the skin of a subject when worn by the subject.

The device 1600 includes one or more surface sensors mounted to a frame, wherein the surface sensors include one or more features related to the surface sensors described in relation to fig. 15. The surface sensor may include a first electrode 1702 and a second electrode 1704 mounted to a first extension 1606, and a third electrode 1706 and a fourth electrode 1708 mounted to a second extension. The surface sensor may also include a combination sensor 1710 mounted to the first extension 1606, where the combination sensor 1710 includes one or more features of the combination sensor 1508 (fig. 15). The surface sensor may also include a sound sensor 1712 mounted to the island 1616.

Fig. 17 also depicts an adhesive applied to the device 1600. In particular, the first adhesive portion 1714 is located on the first extension 1606 and the second adhesive portion 1716 is located on the second extension 1608. The first adhesive portion 1714 and the second adhesive portion 1716 may each include an adhesive and a cover. When the cover is removed, the adhesive may be exposed and may be used to secure the device 1600 to the skin of the subject. For example, the first adhesive portion 1714 may secure the first extension 1606 to the skin of the subject, and the second adhesive portion 1716 may secure the second extension 1608 to the skin of the subject.

Fig. 18 depicts an example control module 1800, according to some embodiments of the present disclosure. The control module 1800 may include one or more features of the control modules described throughout this disclosure, such as the control module 716 (fig. 7) and/or the control module 1416 (fig. 14). In addition, the control module 1800 may be implemented in place of the control module described throughout this disclosure.

The control module 1800 may include one or more of the multi-modality sensing and measurement module 112 (fig. 2), the processor 202 (fig. 2), the transmitter/receiver 204 (fig. 2), the data storage 206 (fig. 2), the memory 208 (fig. 2), or some combination thereof. The control module 1800 may also include a battery for powering the devices implementing the control module 1800. The control module 1800 may be coupled to one or more surface sensors of the device. The control module 1800 may control the operation of the surface sensors and may store data received from the surface sensors. In some embodiments, control module 1800 may store the data and an indication of the time at which the data was captured (e.g., timestamp the data) in order to transmit the data to the cloud (e.g., cloud 110 (e.g., fig. 1) and/or cloud 308 (fig. 3)) in the future. In other embodiments, the control module 1800 may also perform operations on the data prior to transmitting the data to the cloud. For example, the control module 1800 may analyze, trend, reduce, and/or fuse the data, or some portion thereof, prior to transmitting the data to the cloud.

In some embodiments, the control module 1800 may also include a direction detection sensor. The direction detection sensor may determine the direction of the control module 1800, which may be used to determine the direction of the object. For example, the control module 1800 may determine that the subject is standing, lying, or may determine the angle at which the subject is tilted based on the orientation measured by the direction detection sensor. In some embodiments, the direction detection sensor may include an accelerometer that may be used to determine the direction of the control module 1800.

The control module 1800 may also include one or more indicators 1802. For example, the control module 1800 includes a first indicator 1802a and a second indicator 1802b in the illustrated embodiment. The indicator 1802 may indicate a status of the device. For example, the indicator 1802 may indicate a state of an electronic device of the device, an orientation of an object (or indicate that the object transitions to an appropriate orientation to perform a device operation), a data transfer state, a power state, an operational state, or some combination thereof. Indicator 1802 may include a visual indicator, an audible indicator, a motion indicator (e.g., an indicator that generates a physical force including vibration), or some combination thereof. In the illustrated embodiment, the indicators 1802 each include a light that may be illuminated to indicate a device status. In other embodiments, the indicator 1802 may include a light, a display, a speaker, or some combination thereof.

In some embodiments, each indicator 1802 may include a multi-color light (e.g., multi-color LEDs) or multiple lights of different colors (e.g., LEDs of different colors). In some embodiments, indicator 1802 may emit green, yellow, and blue light. Depending on the color of the light being lit, the sequence of light being emitted, whether the light is blinking, and/or whether the light is pulsing, different states of the device may be indicated. For example, a light of a first color may indicate that the device is connected to a communication network when illuminated, that the device is ready to connect to the communication network when flashing, and/or that data is being exchanged with the communication network when pulsing. The second color light may indicate that the device is in a pre-read mode when illuminated and/or is measuring an electrocardiogram of the subject when blinking. The third color light may indicate that the device is fully charged when illuminated, is charging when pulsed, and/or is in a low battery state when blinking. Further, in some embodiments, the sequence of emitted light may indicate that a measurement is being performed, that the direction of the device (determined by the position of the object) is appropriate or needs to be adjusted, that one or more surface sensors are not being properly applied to the object, that the measurement has been completed, or some combination thereof.

In some embodiments, the indicator 1802 may also include a speaker 1802c to emit sound. The speaker 1802c may emit sounds (e.g., beeps and/or tones) that indicate the device status and/or supplement the first indicator 1802a and the second indicator 1802b to indicate the device status. For example, the speaker 1802c may beep and/or tone to indicate that one or more surface sensors are not being properly applied to the object, that the orientation of the device requires adjustment, that measurements have been completed, or some combination thereof.

The control module 1800 may also include a switch 1804 (e.g., a button, slide switch, throw switch, toggle switch, or rotary switch). In the illustrated embodiment, the switch 1804 includes a button. Actuation of the switch 1804 may be detected by the control module 1800 and may cause a process, such as the method 2400 (fig. 24), to be initiated. In some embodiments, the process initiated in response to actuation of the switch 1804 may depend on the amount of time the switch 1804 is actuated. For example, a switch 1804 that is actuated beyond a threshold period of time may cause the current procedure to be paused or the procedure may be restarted.

The control module 1800 may also include a reset pin 1808. In the illustrated embodiment, reset pin 1808 may comprise a button. Actuation of the reset pin 1808 may be detected by the control module 1800 and may reset the control module 1800. In particular, in some embodiments, actuation of the reset pin 1808 may cause the control module 1800 to perform a hard restart.

The control module 1800 may also include a wired connection port 1806. The wired connection port 1806 in the illustrated embodiment includes a universal serial bus type C (USB-C) port. The charger and/or base station, such as base station 1204 (fig. 12) and/or base station 1300 (fig. 13), may be coupled to the wired connection port 1806 by wires for charging the battery of the control module 1800. In some embodiments, the base station and/or another computer device may be coupled to the wired connection port 1806 via wires for transferring data between the control module 1800 and the base station and/or another computer device, updating software and/or firmware of the control module 1800, or some combination thereof.

Fig. 19 illustrates another example base station 1900 in accordance with some embodiments of the disclosure. Base station 1900 may include one or more features of base station 1204 (fig. 12) and/or base station 1300 (fig. 13). Base station 1900 is illustrated as having an apparatus 1902 (which may include one or more features of apparatus 1400 (fig. 14)) mounted to base station 1900. When the device 1902 is mounted to the base station 1900, the device 1902 may be folded at a bending point 1920, where the bending point 1920 includes one or more features of the bending point 710 (fig. 7) and/or the bending point 1410 (fig. 14).

The base station 1900 may include a housing 1904. The housing 1904 may include the body of the base station 1900 and may house the electronics of the base station 1900 within the housing 1904. For example, the housing 1904 may house a processor (e.g., the processor 202 (fig. 2)), a transmitter/receiver (e.g., the transmitter/receiver 204 (fig. 2)), a data memory (e.g., the data memory 206 (fig. 2)), a memory (e.g., the memory 208 (fig. 2)), or some combination thereof.

The housing 1904 may include a wired connection port 1906. In the illustrated embodiment, wired connection ports 1906 include USB-C ports. Wires may be coupled between the wired connection port 1906 and a wired connection port of the device 1902, such as the wired connection port 1806 (fig. 18), to couple the electronics of the base station 1900 with the electronics of the device 1902. When coupled, the base station 1900 may charge the device 1902 and/or exchange data with the device 1902.

Base station 1900 may also include an arm 1908. Arms 1908 may hold device 1902 when device 1902 is mounted to base station 1900. Arms 1908 may be coupled to housing 1904 and extend across one side of housing 1904 in the illustrated embodiment. The side of the housing 1904 may be the front side 1912 of the housing 1904. When the device 1902 is mounted to the base station 1900, a portion of the device 1902 may be located between a portion of the arm 1908 and the housing 1904. Portions of arms 1908 may apply pressure to portions of device 1902 to maintain the position of device 1902 when mounted to base station 1900. The arms 1908 may extend substantially parallel (within 5 degrees) to the front side 1912 of the housing 1904 and have offset portions 1910 that extend toward the front side 1912 of the housing 1904 and apply pressure toward the front side 1912 of the housing 1904. In some embodiments, offset portion 1910 may include a curved portion that extends from a substantially parallel portion of arms 1908 toward front side 1912 of housing 1904. When the device 1902 is mounted to the housing 1904, the offset portion 1910 may apply pressure to the device 1902 to hold the device 1902 in place against the housing 1904.

The base station 1900 may include one or more indicators 1914. The indicators 1914 may include visual indicators, audible indicators, or some combination thereof. In the illustrated embodiment, the base station 1900 includes a first indicator 1914a, a second indicator 1914b, and a third indicator 1914c. In the illustrated embodiment, the indicator 1914 includes a different color light (e.g., a color LED). In particular, in the illustrated embodiment, the first indicator 1914a includes yellow light, the second indicator 1914b includes amber light, and the third indicator 1914c includes green light. In other embodiments, the indicators 1914 may be different colors than those shown, may all be the same color, or some combination thereof.

The indicator 1914 may indicate a status of the base station 1900. For example, indicator 1914 may indicate that base station 1900 is active as a state of base station 1900, whether device 1902 is coupled to base station 1900, whether the base station is connected to a network (e.g., communication network 108 (fig. 1)) or cloud (e.g., cloud 110 (fig. 1)), whether base station 1900 is exchanging data with a network or cloud, a state of charge of device 1902 when coupled to base station 1900, or some combination thereof. The indicator 1914 may indicate the status of the base station 1900 based on the color of the illuminated indicator 1914, whether the indicator 1914 is flashing or stable, or some combination thereof. Further, the indicator 1914 may be used in conjunction with an indicator of the device 1902, such as the indicator 1802 (fig. 18), to indicate a status of the base station 1900 and/or a status of the device 1902.

The base station 1900 may also include a cover 1916. The cover 1916 may be rotatably coupled to the housing 1904 and may rotate between a cover position and a bracket position. In the illustrated embodiment, the cover 1916 is rotatably coupled toward the lower end 1918 of the housing 1904. When in the stand position, the cover 1916 may rotate about the back of the housing 1904 and may contact the back of the housing 1904, with the back side of the housing 1904 opposite the front side 1912 of the housing 1904. The cover 1916 may extend substantially perpendicularly from the rear side of the housing 1904. When the cover 1916 is in the cradle position and placed on a surface, the housing 1904 can rest on the lower end 1918 and tilt rearward, where the cover 1916 contacts the surface and prevents the housing 1904 from tipping rearward. The housing 1904 may be disposed on the lower end 1918, while the cover 1916 is disposed on a surface.

Fig. 20 illustrates the base station 1900 of fig. 19 in accordance with some embodiments of the disclosure. In particular, the base station 1900 is shown with a cover 1916 in a cover position. When in the lid position, the lid 1916 is rotated to extend through the front side 1912 of the housing 1904, wherein a portion of the lid 1916 extends substantially parallel (within 5 degrees) to the front side 1912 of the housing 1904. When in the lid position, the lid 1916 may cover a portion of the device 1902 and a portion of the front side 1912 of the housing 1904. Thus, the cover 1916 may protect portions of the device 1902 and portions of the front side 1912 from damage when in the cover position.

Fig. 21 illustrates an example guide 2100, according to some embodiments of the present disclosure. In some cases, the guide 2100 may be referred to as a stethoscope guide. The guide 2100 may be used to position a system (e.g., system 102 (fig. 1) and/or system 1100 (fig. 11)) or a device (e.g., device 304 (fig. 3), device 400 (fig. 4A), device 500 (fig. 5), device 600 (fig. 6), device 700 (fig. 7), device 1000 (fig. 10), device 1400 (fig. 14), and/or device 1902 (fig. 19)) on an object. In particular, the guide 2100 may be worn by a subject and the guide may indicate where the system or device should be positioned on the subject when worn.

The guide 2100 may include a neck work piece 2102, which neck work piece 2102 is to be worn around the neck of a subject when the system or device is positioned. The neck workpiece 2102 can include a necklace portion 2104 to be placed around the neck of the subject. In some embodiments, the necklace portion 2104 may be semi-rigid allowing the necklace portion 2104 to maintain a shape without a force exceeding a threshold force while allowing some flexibility in response to application of the force exceeding the threshold to facilitate placement of the necklace portion 2104 around the neck of the subject. In other embodiments, the necklace portion 2104 may be rigid. In the illustrated embodiment, the necklace portion 2104 has a circular shape with a hollow center through which the neck of the subject is to be positioned. In other embodiments, the necklace portion 2104 may have other shapes such as oval or polygonal.

The guide 2100 may also include one or more positioning elements 2106 that couple the necklace portions 2104. For example, in the illustrated embodiment, the guide 2100 includes a first positioning element 2106a and a second positioning element 2106b. The positioning element 2106 may extend inwardly from the necklace portion 2104 and may contact the neck of the subject to provide further positioning in addition to the necklace portion 2104. In particular, the first positioning element 2106a will contact a first side of the subject's neck and the second positioning element 2106b will contact a second side of the subject's neck, the second side being opposite the first side, and apply a force to both sides of the subject's neck to center the necklace portion 2104. The positioning element 2106 can be semi-rigid, wherein the positioning element 2106 has a stiffness that is less than the stiffness of the necklace portion 2104. Thus, the necklace portion 2104 may remain in shape while the positioning member 2106 may flex and apply a force to the neck of the subject when the subject wears the neck workpiece 2102. In some embodiments, the positioning element 2106 may be omitted.

The neck workpiece 2102 can also include a mounting portion 2108. The mounting portion 2108 can be coupled to the necklace portion 2104 and can be positioned in front of the subject when the neck workpiece 2102 is worn as desired. In some embodiments, the mounting portion 2108 can be coupled to the necklace portion 2104 and extend outwardly from the necklace portion 2104. The mounting portion 2108 can include a mounting element 2110 for mounting an article to the neck workpiece 2102. In the illustrated embodiment, the mounting element 2110 comprises a hook and loop material (particularly, hook and loop material of a hook and loop fastener) to facilitate mounting of the article to the neck workpiece 2102. In other embodiments, the mounting elements 2110 may comprise other materials that facilitate mounting the article to the neck 2102, such as an adhesive, a flat surface on which suction cups may be mounted, one or more holes, fasteners may be used to mount the article, and/or one or more fasteners may be used to mount the article. The mounting element 2110 may allow an article to be mounted to the mounting portion 2108 in a number of different positions.

The guide 2100 may also include a positioning workpiece 2112. The positioning workpiece 2112 can be coupled to the neck workpiece 2102 and indicate proper positioning of the system or device when coupled to the neck workpiece 2102 and when the neck workpiece 2102 is worn by a subject. Positioning the workpiece 2112 can include extending members 2116. The extension member 2116 may comprise a rigid material and may remain in shape.

Positioning the workpiece 2112 can also include a mounting portion 2114. The mounting portion 2114 may couple with the extension member 2116 and may be positioned toward the first end 2122 of the positioning workpiece 2112. The mounting portion 2114 may include a mounting element that is coupled to the mounting element 2110 of the neck workpiece 2102 to mount the positioning workpiece 2112 to the neck workpiece 2102. The mounting elements of the mounting portion 2114 may comprise hook and loop material (particularly hook and loop material of hook and loop fasteners, wherein the hook and loop material of the mounting element of the mounting portion 2114 is the opposite material from the mounting element 2110) to facilitate mounting of the positioning workpiece 2112 to the neck workpiece 2102. In other embodiments, the mounting elements of the mounting portion 2114 may include other materials to facilitate the mounting of the positioning workpiece 2112, such as an adhesive, suction cups, one or more fasteners available for mounting holes, and/or one or more fasteners for mounting. The mounting portion 2114 can be mounted to a plurality of different positions on the mounting portion 2108, allowing the position of the positioning workpiece 2112 to be adjusted to facilitate objects of different sizes that can utilize the guide 2100.

Positioning the workpiece 2112 can also include an indicating portion 2118. The indicating portion 2118 may indicate where a portion of the system or device should be placed on the object. The indicator portion 2118 may have an edge 2120 of the indicator portion 2118 that is shaped to match an edge of a system or device. In particular, an edge of the system or device will be positioned adjacent to edge 2120 of indicator portion 2118 in order to properly position the system or device on the object. In the illustrated embodiment, the edge 2120 of the indicator portion 2118 includes two curves that match a portion of the system or device and indicate the correct positioning of the system or device adjacent to the two curves. The indicator portion 2118 may be located at a second end 2124 of the positioning workpiece 2112, the second end 2124 being opposite the first end 2122.

Although in the depicted embodiment the guide 2100 has two workpieces (i.e., a neck workpiece 2102 and a positioning workpiece 2112), it should be understood that the guide 2100 may include one or more workpieces, wherein features of the neck workpiece 2102 and the positioning workpiece 2112 may be implemented as one or more workpieces. For example, the neck workpiece 2102 and the positioning workpiece 2112 can be implemented as a single workpiece. In some embodiments, the positioning workpiece 2112 is attached to the neck workpiece 2102.

Fig. 22 illustrates an example positioning arrangement 2200 in accordance with some embodiments of the present disclosure. In particular, fig. 22 shows a portion of the positioning workpiece 2112 of fig. 21 and a portion of the apparatus 1400 of fig. 14, wherein the positioning workpiece 2112 and the apparatus 1400 are positioned to be positioned to position the apparatus 1400 on an object.

The depicted portion of the positioning workpiece 2112 includes an indicating portion 2118. Indicator portion 2118 includes edge 2120. The device 1400 is positioned near an edge 2120 of the indicator portion 2118. In particular, edge 2202 of device 1400 is located near edge 2120 of the indicator portion. In the illustrated embodiment, the edge 2202 is an edge of the first extension 1406a of the device 1400, wherein a portion of the first extension 1406a including the edge 2202 is located adjacent to the indicator portion 2118. The device 1400 may be secured to the subject (e.g., by adhesive 900 (fig. 9)) when positioned adjacent to the indicator portion 2118. The guide 2100 (fig. 21) may be removed from the subject after the device 1400 has been positioned.

Fig. 23 depicts additional example guides 2300, according to some embodiments of the disclosure. The guide 2300 may include one or more features of the neck workpiece 2102 (fig. 21). The guide 2300 may be used to position a workpiece, such as the workpiece 2112 (fig. 21), to position the device on the object.

The guide 2300 may include a hook 2302, wherein the hook 2302 has a hook shape. When positioned on a subject, the neck of the subject may be positioned within the opening formed by the hook 2302, with the hook of the hook 2302 extending along the rear of the subject neck. The guide 2300 may be supported on the subject by a hook 2302 placed around the subject's neck.

The guide 2300 may also include a socket 2304. The socket 2304 may be coupled to the hook 2302. Further, the socket 2304 may engage with a device and facilitate positioning the device on a subject. When the hook 2302 is properly positioned around the neck of the subject, the socket 2304 may indicate proper positioning of the device and may engage the device to properly position the device on the subject.

An example method of non-invasively detecting and monitoring a medical or health condition of a human subject using a variety of sensing modalities is described below with reference to fig. 24 and fig. 1-3. At block 2402, system 102 (see fig. 1-3), a device (e.g., device 304, device 400, device 500, device 600, and/or device 700) configured with a suitable shape is positioned on human subject 104 such that it contacts a suitable portion or area of the body via at least the plurality of surface electrodes/sensors 114a-114d, wherein the suitable portion or area of the body corresponds to the positioning of the device, system, and/or surface sensor (e.g., electrode) described throughout this disclosure. Once the system 102 is positioned in contact with the appropriate portion or area of the body, the plurality of multi-modal sensing and measurement modules 112 are activated to obtain multi-modal sensed data from the human subject 104, including, but not limited to, one or more of chest impedance sensed data, ECG sensed data, respiratory rate and tidal volume sensed data, heart rate variability/heart sound based sensed data, and pulse oximetry sensed data, at block 2404. At block 2406, the multimodal sensory data is provided to the data analyzer 226 for at least partial data analysis, data trend analysis, and/or data reduction. At block 2408, the analyzed multi-modal sensed data is provided to a data fusion/decision engine 228, which effectively at least partially fuses or combines the multi-modal sensed data for subsequent use in making one or more inferences 104 about the medical or health condition of the human subject. At block 2410, the combined multimodal sensing data is provided to the transmitter/receiver 204, which transmits at least a portion of the combined multimodal sensing data to the cloud 110 over the wireless communication path 122 for possible further data analysis, trend analysis, reduction, and/or fusion. The partially combined multimodal sensing data may also be transmitted over the wireless communication path 122 to the cloud 110 for remote download by a hospital clinician for monitoring and/or tracking purposes.

Fig. 25 is a diagram depicting an apparatus 2500 for detecting and monitoring a health condition of a subject, according to some embodiments of the present disclosure. In particular, device 2500 non-invasively detects and monitors a COPD condition of a human subject. The device 2500 is an elongated rectangular element 2512 and includes a first electrode 2502a, a second electrode 2502b, and a third electrode 2502c. The elongate rectangular element 2512 may comprise the frame of the device 2500. The first electrode 2502a is located at a first end of the elongated rectangular element 2512, the second electrode 2502b is located at about the center of the elongated rectangular element 2512, and the third electrode 2502c is located at a second end of the elongated rectangular element 2512. In use, the device 2500 is positioned on a subject's torso and the electrodes 2502a-2502c are positioned in contact with the skin of the subject. As described above with respect to the system 102 of fig. 1, data from the electrodes 2502a-2502c is connected to a plurality of multi-modal sensing and measurement modules (e.g., module 112 shown in fig. 2) that may be activated to collect, sense, measure, or otherwise obtain multi-modal sensed data from a subject.

For detecting and/or monitoring COPD, heart sound sensors are located higher on the torso in order to better detect lung sounds. The measurement of COPD includes impedance for determining respiration rate, ECG (if needed), impedance for determining tidal volume, lung sounds (for detecting abnormal lung trajectory), and impedance for measuring the shape of changes in lung volume. In particular, changes in the shape of impedance changes indicate lung/airway resistance, which can be used to determine the presence of COPD.

26A-26G are diagrams illustrating various examples of electrode and sensor torso placement for detecting and monitoring a health condition of a subject, according to some embodiments of the present disclosure. In fig. 26A, four elements 2602a-2602d are positioned on the torso of the subject, generally above the heart of the subject. One element 2602a is located at the apex of the heart, in the fifth intercostal space. According to some examples, the apex of the heart placing 2602a in the fifth intercostal space is generally optimal for detection of S3 and S4 heart sounds.

In fig. 26B, elements 2604a-2604d are positioned across the torso and positioned to measure impedance across both lungs. Element 2606 is a microphone for detecting heart sounds. The device including elements 2604a-2604d extends across the width of the torso. In some embodiments, it may be held in place with a strap that surrounds the torso. Elements 2604a-2604d may also be used to measure ECG.

In fig. 26C, elements 2608a-2608d are located on one side of the torso and measure impedance across one lung. Element 2606 is a microphone for detecting heart sounds. The device including elements 2608a-2608d extends across one side of the torso. In one example, an apparatus, such as apparatus 400 in fig. 4A, may include elements 2608a-2608d and 2606. Elements 2608a-2608d may also be used to measure ECG.

Fig. 26D shows elements 2608a-2608D and 2606 of fig. 26C, as well as additional elements 2610. Element 2610 may be used with any of elements 2608a-2608d to measure ECG.

Fig. 26E shows elements 2612a-2612d, 2614a-2614b, and 2606. Elements 2612a-2612d and 2614a-2614b may be used to measure impedance and to measure ECG. The configuration of the elements 2612a-2612d, 2614a-2614b and 2606 may be implemented in a device such as a vest or shirt.

Fig. 26F illustrates another example of placement of electrodes and sensors on an object. In particular, fig. 26F illustrates a diagram of a portion of a subject's body, including a subject's lungs 2616.

In this example, the first electrode arrangement 2618 and the second electrode arrangement 2620 may be located at or towards a first side of the lung 2616, and the third electrode arrangement 2622, the fourth electrode arrangement 2624 and the fifth electrode arrangement 2626 may be located at or towards a second side of the lung 2616. In some embodiments, the third electrode 1002c (fig. 10) may be positioned at the first electrode arrangement 2618 and the fourth electrode 1002d (fig. 10) may be positioned at the second electrode placement 2620 on the first side of the lung 2616. The first electrode 1002a (fig. 10) may be located at a third electrode arrangement 2622, the second electrode 1002b (fig. 10) may be arranged at a fourth electrode arrangement 2624, and the reference electrode 1002e (fig. 10) may be located at a fifth electrode arrangement 2626.

Further, a series of sound sensor arrangements 2628 are shown in fig. 26F. In particular, sound sensors, such as sound sensor 1004 (fig. 10), may be placed anywhere along the line of sound sensor arrangement 2628. The sound sensor arrangement 2628 may be positioned toward the lower portion of the lung 2616 and near to the core of the subject. In some embodiments, the sound sensor placement 2628 may extend 10cm from the midline of the subject to one side of the midline of the subject.

Fig. 26G illustrates another example of placement of electrodes and sensors on an object. In particular, fig. 26G illustrates the apparatus 1400 of fig. 14 positioned on a body 2630 of a subject. In the illustrated embodiment, the device 1400 is positioned on the chest 2632 of the subject.

The first extension 1406a of the device 1400 is positioned over the heart 2634 of the subject and on a first side of the ribs 3706 of the subject. Thus, the electrodes and/or sensors (e.g., combination sensor 1508 (fig. 15), third electrode 1502c (fig. 15), fourth electrode 1502d (fig. 15), and/or acoustic sensor 1504 (fig. 15)) located on first extension 1406a are located on a first side of rib 3706. The device 1400 extends through a rib 3706 of the subject, wherein a second extension 1406b of the device 1400 is located on a second side of the rib 3706, the second side of the rib 3706 being opposite to the first side of the rib 3706. Thus, electrodes and/or sensors (e.g., first electrode 1502a (fig. 15) and/or second electrode 1502b (fig. 15)) located on second extension 1406b are located on a second side of rib 3706.

Fig. 27 depicts an example user interface 2700, according to some embodiments of the present disclosure. The user interface 2700 may be displayed on a computer device, such as the smartphone 106 (fig. 1). In particular, user interface 2700 may be displayed on a display of a computer device.

The user interface 2700 may include a list of objects 2702. The list of objects 2702 may include one or more objects that have utilized the systems or apparatuses disclosed herein, such as system 102 (fig. 1), system 1100 (fig. 11), or apparatus 304 (fig. 3), apparatus 400 (fig. 4A), apparatus 500 (fig. 5), apparatus 600 (fig. 6), apparatus 700 (fig. 7), apparatus 1000 (fig. 10), apparatus 1400 (fig. 14), and/or apparatus 1902 (fig. 19). In the depicted embodiment, object list 2702 includes objects 1 through 7. Although objects are generally labeled in FIG. 27, it should be understood that in embodiments objects may be labeled by an identifier for each object, where the identifier may include the name of the object and/or a character associated with each object.

The user interface 2700 may also include an attention indicator 2704, wherein each object within the list of objects 2702 may have a corresponding attention indicator of the attention indicator 2704. The attention indicator 2704 may indicate whether the measurement captured by the systems or devices disclosed herein indicates that the corresponding object requires attention or viewing by a user of the user interface. In particular, the attention indicator 2704 may indicate that the subject is experiencing a medical emergency, a measurement by a system or device that is within the scope of interest for medical reasons, or some combination thereof. In the illustrated embodiment, the attention indicator 2704 includes a plurality of check boxes, wherein the check boxes may be filled to indicate that the data of the respective subject matter requires attention or viewing by the user and may be left blank to indicate that the respective object does not require attention or viewing. In some embodiments, objects in the object list 2702 may be ordered based on whether the corresponding attention indicator 2704 indicates that attention or review is required. In other embodiments, the user interface 2700 may also include a time of last reading of each object in the object list 2702, whether each object in the object list 2702 has completed a predetermined measurement, a trend of measured values for each object in the object list 2702, a vital sign trend of each object in the object list 2702, or some combination thereof. Further, the user interface 2700 may include an indication of the number of objects that have been indicated by the user for monitoring, the number of high risk objects, the number of pending actions, the number of new readings, or some combination. In response to a user interacting with an object listed in the object list, any attention indicator, or any other indication, another user interface including corresponding information may be displayed. For example, in response to a user interacting with an object (e.g., clicking a mouse, or placing a finger in an associated area on a touch screen), a user interface may be displayed that displays object data.

Fig. 28 depicts a further example user interface 2800, according to some embodiments of the present disclosure. In particular, user interface 2800 may display information for an object. User interface 2800 may be displayed in response to a user interacting with one of the objects in object list 2702 (fig. 27) on user interface 2700 (fig. 27). User interface 2800 may be displayed on a computer device, such as smart phone 106 (fig. 1). In particular, user interface 2800 may be displayed on a display of a computer device.

The user interface 2800 may include an object indication 2802 that indicates an object for which data is being displayed. The user interface 2800 may also display data 2804 for the object. Data 2804 may include a feature 2806 of the object and a value 2808 corresponding to the feature 2806. In the illustrated embodiment, features 2806 include systolic pressure, diastolic pressure, weight, and International Normalized Ratio (INR) of the subject. In other embodiments, features 2806 may include other features of the object that may be derived from the captured data.

Fig. 29 depicts an additional example user interface 2900, according to some embodiments of the disclosure. The user interface 2900 may be displayed on a computer device such as the smart phone 106 (fig. 1). The user interface 2900 may display a number of fields that allow a user to select a display action and define characteristics that indicate when the display action is performed. Displaying the actions may include displaying an indication on a display of the computer device, displaying data on a display of the computer device, displaying an indication related to the displaying action on a base station (e.g., base station 1204 (fig. 12), base station 1300 (fig. 13), and/or base station 1900 (fig. 19)), displaying an indication related to the displaying action on a device (e.g., system 102 (fig. 1), device 304 (fig. 3), device 400 (fig. 4A), device 500 (fig. 5), device 600 (fig. 6), device 700 (fig. 7), device 1000 (fig. 10), device 1102 (fig. 11), device 1400 (fig. 14), device 1902 (fig. 19), and/or device 2500 (fig. 25)), or some combination thereof. The indication may include displaying a light, sounding a sound, generating a physical force, displaying a message, or some combination thereof.

The user interface 2900 may include a display operations field 2902. The display operation field 2902 allows the user to select a display action to be performed. In the illustrated embodiment, the display action selected in display operation field 2902 is a CHF alert. The display operations field 2902 may include a drop down menu or list that displays one or more display actions that may be selected. In some embodiments, display operations field 2902 may allow a user to generate a display action and define an action to perform in response to a triggered display action, and/or edit an operation to perform in response to a previously defined trigger display operation.

The user interface 2900 may also include one or more feature fields 2904. For example, in the illustrated embodiment, the user interface 2900 includes a first feature field 2904a for diastolic pressure and a second feature field 2904b for chest impedance differences. Feature field 2904 allows the user to select a feature for determining when to trigger a display action. In some embodiments, each of the feature fields 2904 may include a drop down menu or list that displays one or more features that may be used to determine when to trigger a display action. Features included in the drop down menu or list may include any feature associated with data captured by the device, any feature or information (e.g., age, weight, and/or medical history) that may be derived from data captured by the device (e.g., system 102 (fig. 1), device 304 (fig. 3), device 400 (fig. 4A), device 500 (fig. 5), device 600 (fig. 6), device 700 (fig. 7), device 1000 (fig. 10), device 1102 (fig. 11), device 1400 (fig. 14), device 1902 (fig. 19), and/or device 2500 (fig. 25)) associated with an object that may use the device. In some embodiments, one or more display actions may have corresponding characteristics, where when a display action is selected in display operation field 2902, the corresponding characteristic is displayed in characteristics field 2904. Further, the user interface 2900 may allow a user to add or remove feature fields 2904 in some embodiments, wherein when a user adds or removes feature fields 2904, one or more feature fields 2904 may be included on the user interface 2900. In some embodiments, user interface 2900 may allow a user to define new feature fields, as well as measurements and/or inputs for determining values corresponding to the feature fields.

The user interface 2900 may also include one or more relationship fields 2906. Each feature field of feature fields 2904 may have a relationship field of corresponding relationship fields 2906. For example, in the illustrated embodiment, the first relationship field 2906a corresponds to a first feature field 2904a, and the second relationship field 2906b corresponds to a second feature field 2904b. The relationship field 2906 allows a user to define a relationship between a measured or calculated value of a characteristic and a characteristic threshold. For example, the relationship field 2906 may include entries greater than, less than, equal to, between, and/or beyond, where the entries are used to determine when a display operation should be triggered when comparing a measured or calculated value to a threshold value. For example, when an entry of the relationship field is selected to be greater than a threshold, a display action may be triggered when the measured or calculated value is greater than a threshold. Further, between entries may indicate that a display action may be triggered when a measured or calculated value is between a first threshold and a second threshold, while an outside entry may indicate that a display action may be triggered when a measured or calculated value is outside of a range defined by the first threshold and the second threshold.

The user interface 2900 may also include one or more threshold fields 2908. Each feature field of feature fields 2904 may have one or more threshold fields of corresponding threshold fields 2908. For example, in the illustrated embodiment, the first threshold field 2908a corresponds to a first feature field 2904a and the second threshold field 2908b corresponds to a second feature field 2904b. The threshold field 2908 allows a user to define a threshold for the feature of the corresponding feature field 2904. Further, each relationship field 2906 may have one or more corresponding threshold fields of threshold fields 2908. For example, a first threshold field 2908a corresponds to a first relationship field 2906a and a second threshold field 2908b corresponds to a second relationship field 2906b.

The entries of the feature field 2904, correspondence field 2906, and correspondence threshold field 2908 may define when the corresponding display action should be performed. For example, each of the feature fields 2904 may be used to define a feature for which a measured or calculated value should be obtained to determine whether a corresponding display action is to be performed. The relationship field of the relationship field 2906 and one or more threshold fields of the threshold fields 2908 corresponding to the feature field may be used to define an equation for the feature of the feature field, where the equation indicates that a display action may be performed when the measured or calculated value satisfies the equation. For example, the entry of the first feature field 2904a in the illustrated embodiment indicates that a measurement or calculated value of diastolic pressure is to be obtained for the CHF alert display action selected in the display operation field 2902. The first relationship field 2906a and the first threshold field 2908a define an equation for x, where x is a measured or calculated value, greater than 115 in the illustrated embodiment. Therefore, if the actual measurement value or the calculated value of the diastolic blood pressure is larger than 115 (so that the equation is satisfied), it indicates that the display operation should be performed.

In some embodiments, the display action may be performed in response to all defined equations satisfying the characteristic. In other embodiments, the display action may be performed in response to a portion of the defined equation for the feature being satisfied. In some embodiments, the user may define which equations to satisfy or which combinations of equations to satisfy to trigger execution of the display action. For example, the user may define that all equations are to be satisfied for the performance to be triggered, that a first portion of the equations and a second portion of the equations are to be satisfied for the performance to be triggered, i.e., that the first portion of the equations or the second portion of the equations are to be satisfied for the performance to be triggered, or some combination thereof. In some embodiments, user interface 2900 may include one or more fields that allow a user to define the relationships between each portion and which equation portions are included in operands (e.g., and operands and or operands) to trigger the presentation of a display action.

Having described illustrative embodiments of systems, devices, and methods for non-invasively detecting and monitoring medical or health conditions, such as chronic diseases (including CHF), in a human subject using a variety of sensing modalities, other alternate embodiments and/or variations may be made and/or practiced. For example, it is described herein that the chest impedance measurement module 212, the ECG measurement module 214, the respiratory rate and tidal volume measurement modules 216, 218, the heart sound based measurement module 220, and the pulse oximetry module 222 may provide corresponding multimodal sensing data to the data analyzer 226 for subsequent data analysis, data trend analysis, and/or data reduction. In alternative embodiments, one or more of the plurality of multi-modal sensing and measurement modules 112 may further obtain multi-modal sensing data, e.g., regarding noninvasive, systolic and/or diastolic pressures between the chest and fingers of a human subject based on Pressure Wave Velocity (PWV), and/or cardiac output data based on direct measurement of at least cardiac contractility, and provide these additional sensing data modalities to the data analyzer 226 for further data analysis, data trend analysis, and/or data reduction. Cardiovascular feedback loops (see FIGS. 30A and 30B)

The nervous system receives a signal that blood pressure is decreasing. To ensure survival, the brain signals the heart, kidneys and arteries, each of which plays a role in diverting blood flow to major organs and maintaining blood pressure. The heart beats faster and more forcefully in response to signals from the brain. This increases the circulating blood pressure of the body. It will then send feedback to the brain informing that a change has occurred and stopping the intervention of the nervous system. Signals from the brain stimulate the adrenal glands (a member of the endocrine system located at the top of each kidney) to secrete epinephrine (commonly referred to as epinephrine) and norepinephrine into the blood. Upon reaching the target organ, it alters their activity. Arteries respond to signals from the brain by altering arterial flow resistance to assist in vivo blood pressure. Changes in vascular tone transfer blood from muscle to viscera, as their health most directly affects survival. The artery sends feedback to the brain informing it of the change.

What is "heart failure"? (see FIG. 31)

The 2013 ACCF/AHA heart failure guide defines heart failure as "complex clinical syndrome caused by any structural or functional dysfunction of ventricular filling or blood ejection". Cardiac pump dysfunction leading to symptoms:

And (3) heart: the occurrence of any clinical heart failure must include primary or secondary involvement of the heart. If this is not obvious, either we look insufficiently careful or heart failure.

And (3) a pump: a complete description of the heart includes a variety of functions including electrical, hormonal, and structural components. However, to develop heart failure, it is necessary to have a significant impact on the ability of the heart to move blood through the circulation.

Damage: injury means a degree of dysfunction and often does not require complete replacement therapy. It may be uncovered only by movement or pressure. If a letter rating is given, the heart function of the patient will be rated as C+ instead of F. Nevertheless, a person suffering from heart failure must have some degree of reduced function.

Results: initial damage to the heart may result in directly severe or subtle impairment of cardiac pump function, but over time. Neurohormonal mechanisms may be activated and lead to this syndrome. This may include adverse structural and biochemical remodeling. Any process affecting the heart must be causally related to the individual's state leading to heart failure.

Stage: the ACC/AHA heart failure classification defines 4 phases of heart failure, starting with (1) risk factors for heart failure, (2) asymptomatic heart failure, (3) symptomatic heart failure, and (4) advanced heart failure.

Some examples of the subject matter disclosed herein are listed below. It should be understood that the embodiments do not limit the scope of the disclosure and that the scope of the disclosure includes all that is described herein.

Example 1 may include an apparatus for non-invasively detecting and monitoring a medical condition using a plurality of sensing modalities, comprising: at least two electrodes configured to be positioned on an object, an acoustic sensor configured to be positioned on the object; a thoracic impedance measurement module connected to the at least two electrodes for measuring a first impedance between the at least two electrodes; and a heart sound measurement module connected with the acoustic sensor for detecting and measuring heart sounds from the acoustic sensor.

Example 2 may include the apparatus of example 1 or some other example herein, further comprising a sensor for determining an orientation of the apparatus.

Example 3 may include the device of example 2 or some other example herein, wherein the chest impedance measurement module measures a first impedance when the device is in a first orientation and measures a second impedance between the at least two electrodes when the device is in a second orientation.

Example 4 may include the apparatus of example 3 or some other example herein, wherein the first direction indicating device is approximately horizontal and wherein the second direction indicating device is angled with respect to the horizontal.

Example 5 may include the apparatus of example 1 or some other example herein, wherein the thoracic impedance measurement module automatically measures the first impedance at regular intervals.

Example 6 may include the apparatus of example 1 or some other examples herein, further comprising an electrocardiogram measurement module connected to the at least two electrodes to measure electrical activity between the at least two electrodes.

Example 7 may include the apparatus of example 1 or some other example herein, wherein the acoustic sensor is one of an ultrasonic sensor and a piezoelectric microphone sensor.

Example 8 may include the apparatus of example 1 or some other example herein, wherein the at least two electrodes comprise at least two electrode pairs, each electrode pair comprising a force electrode configured to apply a current to the subject and a sense electrode configured to sense a change caused by the applied current.

Example 9 may include the apparatus of example 1 or some other example herein, wherein the center sound is S3 heart sound.

Example 10 may include a system for non-invasively detecting and monitoring medical conditions using a plurality of sensing modalities, including: an apparatus positioned on an object, having a plurality of surface sensors and a plurality of sensing modules connected to the plurality of surface sensors, configured to collect multi-modal sensing data; wherein the multi-modal sensing data comprises: a first impedance between at least two surface sensors; and heart sounds from at least one of the plurality of surface sensors; and a data analyzer for performing at least one of data analysis, data trend analysis, and data reduction of the multi-modal sensed data.

Example 11 may include the system of example 10 or some other example herein, further comprising a data decision engine configured to incorporate at least some of the multi-modal sensed data, wherein the combined multi-modal sensed data is indicative of a state of the medical condition of the subject.

Example 12 may include the system of example 11 or some other examples herein, further comprising a transceiver configured to transmit the combined multi-modal sensed data to the cloud over at least one wireless communication path for further processing.

Example 13 may include the system of example 10 or some other example herein, wherein the apparatus further comprises a sensor to determine an orientation of the apparatus.

Example 14 may include the system of example 13 or some other example herein, wherein the apparatus comprises: a thoracic impedance measurement module configured to measure a first impedance when the device is in a first orientation and a second impedance between the at least two surface sensors when the device is in a second orientation.

Example 15 may include the system of example 10 or some other example herein, wherein the apparatus further comprises an electrocardiogram measurement module coupled to the plurality of surface sensors for measuring electrical activity between the at least two surface sensors.

Example 16 may include the system of example 10 or some other example herein, wherein the surface sensor includes at least one of an electrode, a heart sound sensor, an ultrasonic sensor, and a photoplethysmographic pulse wave sensor.

Example 17 may include a method for non-invasively detecting and monitoring a medical condition using a plurality of sensing modalities, comprising: transmitting current percutaneously from a first electrode located on a subject, receiving current percutaneously at a second electrode located on the subject; measuring a voltage between the first and second electrodes; determining a thoracic impedance based at least on the voltage; receiving an acoustic signal from an acoustic sensor; measuring heart sounds from the acoustic sensor; and transmitting the chest impedance data and the heart sound measurements to a data analyzer configured to perform at least one of data analysis, data trend analysis, and data restoration of the chest impedance data and the heart sound measurements.

Example 18 may include the method of example 17 or some other example herein, further comprising determining an orientation of the apparatus.

Example 19 may include the method of example 18 or some other example herein, wherein the thoracic impedance is determined when the device is in a first orientation, and further comprising determining a second impedance measurement between the first electrode and the second electrode when the device is in a second orientation.

Example 20 may include the method of example 17 or some other example herein, further comprising measuring electrical activity between the first and second electrodes and generating an electrocardiogram.

Example 21 may include an apparatus for capturing measurements related to the health of a subject, comprising: a frame to be worn on the skin of the subject, the frame having a main body, a first extension coupled to a first end of the main body, and a second extension coupled to a second end of the main body, a first electrode mounted to the first extension, the first electrode applying an electric potential to the subject, a second electrode mounted to the second extension, the second electrode detecting a disturbance caused by the applied electric potential, and a sound sensor mounted to the first extension or the second extension, the sound sensor detecting heart sounds of the subject.

Example 22 may include the apparatus of example 21, further comprising a control module mounted to the frame and coupled to the second electrode and the acoustic sensor, the control module to receive first data related to interference from the second electrode, receive second data related to the heart sounds from the acoustic sensor, and fuse the first data with the second data into combined data.

Example 23 may include the apparatus of example 22, wherein the control module is further coupled to the first electrode, the control module to cause the first electrode to apply an electrical potential.

Example 24 may include the apparatus of example 22, wherein the control module includes one or more indicators, and wherein the control module causes the one or more indicators to provide an indication of the status of the apparatus.

Example 25 may include the apparatus of example 21, wherein the potential is a first potential and the perturbation is a first perturbation, and wherein the apparatus further comprises a third electrode mounted to the first extension, the third electrode applying a second potential to the object, and a fourth electrode mounted to the second extension, the fourth electrode detecting a second perturbation caused by the applied second potential.

Example 26 may include the apparatus of example 21, further comprising a reference electrode mounted to the frame, the reference electrode detecting an electrical potential of the subject's body.

Example 27 may include the apparatus of example 26, further comprising a control module mounted to the frame and coupled to the second electrode and the reference electrode, the control module to receive first data related to interference from the second electrode and to receive second data related to body potential from the reference electrode, wherein the control module is to utilize the second data to facilitate processing of the first data.

Example 28 may include the apparatus of example 21, further comprising a temperature sensor mounted to the frame, the temperature sensor to detect a temperature of the object.

Example 29 may include the apparatus of example 21, further comprising a combination sensor mounted to the frame, the combination sensor having a reference electrode for detecting an electrical potential of the subject's body and a temperature sensor for detecting a temperature of the subject.

Example 30 may include a base station coupled to a device for capturing measurements related to the health of a subject, the base station including a housing and an electronic device located within the housing, the electronic device coupled to the device and analyzing data received from the device to determine physiological information of the subject based on the data.

Example 31 may include the base station of example 30, wherein the electronic device comprises a processor, wherein the processor is to analyze the data and determine the physiological information.

Example 32 may include the base station of example 31, wherein the electronic device includes a transmitter/receiver to wirelessly communicate with and provide physiological information to the computer device.

Example 33 may include the base station of example 32, wherein the computer device comprises a smart phone or cloud.

Example 34 may include the base station of example 30, further comprising an arm coupled to the housing and holding the device when the device is mounted to the base station.

Example 35 may include the base station of example 34, wherein the arm includes an offset portion configured to contact the device when the device is mounted to the base station, and wherein the offset portion is to apply a force to the device to hold the device.

Example 36 may include the base station of example 30, further comprising a cover rotatably coupled to the housing, the cover rotatable between a cover position and a stand position, wherein the cover extends across a front side of the housing when in the cover position, and wherein the cover is positioned on a rear side of the housing when in the stand position, and contacts and at least partially supports the base station on the surface when the base station is positioned on the ground.

Example 37 may include the base station of example 30, further comprising one or more indicators, wherein the one or more indicators are to indicate a status of the base station.

Example 38 may include a system for capturing measurements related to the health of a subject, the system comprising means comprising: a frame and one or more surface sensors mounted to the frame; and a guide to facilitate positioning of the device on the subject, wherein a portion of the guide indicates a proper position of the device on the subject when the guide is worn by the subject.

Example 39 may include the system of example 38, wherein the edge of the device indicates a location on the object for a certain edge of the device to indicate a proper location of the device.

Example 40 may include the system of example 38, wherein the guide comprises: a neck workpiece worn around the subject's neck to facilitate positioning of the device; and a positioning workpiece mounted to the neck workpiece, wherein the positioning workpiece is used to indicate the proper position of the device when the positioning workpiece is mounted to the neck workpiece and the neck workpiece is worn around the subject's neck.

Example 41 may include the system of example 40, wherein a position at which the positioning workpiece is mounted to the neck workpiece is adjustable.

Example 42 may include the system of example 38, wherein the one or more surface sensors include a first electrode, a second electrode, and a sound sensor.

Example 43 may include a guide for positioning a device on an object, the guide comprising: a neck workpiece positioned around a neck of the subject; and positioning the workpiece with an indication portion indicating a proper position of the device on the object when the neck workpiece is positioned around the neck of the object.

Example 44 may include the guide of example 43, wherein the neck piece comprises a necklace portion having an annular shape (with a hollow center), and wherein the neck portion of the subject is located within the hollow center of the necklace portion when the neck piece is positioned around the neck portion of the subject.

Example 45 may include the guide of example 44, further comprising a first positioning element coupled to the necklace portion and a second positioning element coupled to the necklace portion, wherein the first positioning element and the second positioning element extend inwardly from the necklace portion, and wherein the first element positioning element and the second positioning element contact the neck of the subject when the neck piece is positioned around the neck of the subject to facilitate positioning of the necklace portion.

Example 46 may include the guide of example 45, wherein the first positioning element is coupled to a first side of the necklace portion and the second positioning element is coupled to a second side of the necklace portion opposite the first side of the necklace portion.

Example 47 may include the guide of example 43, wherein the positioning workpiece is adjustably coupled to the neck workpiece.

Example 48 may include the guide of example 47, wherein the neck workpiece includes a mounting portion that positions the workpiece including a mounting portion, and wherein the mounting portion of the neck workpiece couples the mounting portion of the positioning workpiece such that the positioning workpiece couples the neck workpiece.

Example 49 may include the guide of example 43, wherein the indicating portion includes positioning an edge of the workpiece, and wherein the indicating portion indicates that the device is positioned proximate the edge to obtain the proper position.

Example 50 may include a system for monitoring a medical or health condition of a subject, the system comprising a device worn by the subject, the system comprising a sensor for capturing data associated with the subject, a base station communicatively coupled to the device, a base station for retrieving data to the device and processing the data to produce processed data, and a computer device communicatively coupled to the base station, the computer device retrieving the processed data from the base station and displaying information based on the processed data.

Example 51 may include the system of example 50, wherein the sensor comprises an electrode, a sound sensor, or a temperature sensor, and wherein the data comprises a representation of a current, a voltage, heart sounds, a temperature of the subject.

Example 52 may include the system of example 50, wherein the base station processing the data includes fusing the data with other data captured by and retrieved from the device.

Example 53 may include the system of example 50, wherein the base station includes a housing and an arm, wherein the arm holds the device against the housing when the device is mounted to the base station.

Example 54 may include the system of example 50, wherein the information includes processed data.

Example 55 may include the system of example 50, wherein the computer device is to receive a user selection and to generate an equation associated with the display action based on the user selection, the equation including processed data, and to perform the display action when the equation is satisfied.

Example 56 may include the system of example 55, wherein displaying the action comprises displaying an indication of the base station or the device.

Example 57 may include an apparatus for capturing measurements related to the health of a subject, comprising: a frame to be worn on the skin of the subject, the frame having a main body, a first extension coupled to a first end of the main body, and a second extension coupled to a second end of the main body, a first electrode mounted to the first extension, the first electrode applying an electric potential to the subject, a second electrode mounted to the second extension, the second electrode detecting a disturbance caused by the applied electric potential, and a sound sensor mounted to the first extension or the second extension, the sound sensor detecting heart sounds of the subject.

Example 58 may include the apparatus of example 57, further comprising a control module mounted to the frame and coupled to the second electrode and the acoustic sensor, the control module to receive first data related to interference from the second electrode, receive second data related to the heart sounds from the acoustic sensor, and fuse the first data and the second data to generate fused data.

Example 59 may include the apparatus of example 58, wherein the control module is further coupled to the first electrode, the control module to cause the first electrode to apply an electrical potential.

Example 60 may include the apparatus of example 58, wherein the control module includes one or more indicators, and wherein the control module causes the one or more indicators to provide an indication of the status of the apparatus.

Example 61 may include the apparatus of example 57, wherein the potential is a first potential and the disturbance is a first disturbance, and wherein the apparatus further comprises a third electrode mounted to the first extension, the third electrode applying a second potential to the object, and a fourth electrode mounted to the second extension, the fourth electrode detecting a second disturbance caused by the applied second potential.

Example 62 may include the apparatus of example 61, wherein a first vector is formed between the first electrode and the second electrode, wherein a second vector is formed between the third electrode and the fourth electrode, wherein the second vector is located above the first vector when the apparatus is located on the subject's skin.

Example 63 may include the apparatus of example 57, further comprising a reference electrode mounted to the frame, the reference electrode detecting a potential of the subject's body.

Example 64 may include the apparatus of example 63, further comprising a control module mounted to the frame and coupled to the second electrode and the reference electrode, the control module to receive first data related to interference from the second electrode and second data related to body potential from the reference electrode, and to utilize the second data to facilitate processing of the first data.

Example 65 may include the apparatus of example 57, further comprising a temperature sensor mounted to the frame, the temperature sensor to detect a temperature of the object.

Example 66 may include the apparatus of example 57, further comprising a combination sensor mounted to the frame, the combination sensor having a reference electrode for detecting an electrical potential of the subject's body and a temperature sensor for detecting a temperature of the subject.

Example 67 may include a system for monitoring the health of a subject, comprising: a measurement device for collecting a measurement related to the health of the subject, comprising a first electrode coupled to a first extension of the device, the first extension abutting against the subject's skin on a first side of the subject's lung, the first electrode applying an electrical potential to the subject's skin, a second electrode coupled to a second extension of the device, the extension being at an opposite end of the first extension of the device, the second extension abutting against the subject's skin on a second side of the subject's lung, the second electrode detecting a disturbance caused by the applied electrical potential, and a base station coupled to the device, the base station retrieving data related to the disturbance detected from the device and uploading the data to the cloud.

Example 68 may include the system of example 67, wherein the base station comprises one or more indicators to indicate that data is to be retrieved from the device and uploaded to the cloud.

Example 69 may include the system of example 67, wherein the apparatus further comprises a sound sensor coupled to an island of the apparatus, the island coupled to one of the first extension or the second extension, wherein the island abuts against a subject's skin proximate an apex of the subject's heart, and wherein the sound sensor senses heart sounds of the subject.

Example 70 may include the system of example 69, wherein the base station is further to retrieve heart sounds sensed from the device by the sound sensor and provide the heart sounds to the cloud replay.

Example 71 may include the system of example 67, wherein the apparatus further comprises a control module having one or more indicators, the control module coupled to the first electrode and the second electrode, wherein the control module is to capture a first measurement of the disturbance detected by the second electrode when the apparatus is against the subject's skin and in a first orientation, to indicate by the one or more indicators that the subject is repositioned by the apparatus when the apparatus is against the subject's skin to be in a second orientation, and to capture a second measurement of the disturbance detected by the second electrode when the apparatus is against the subject's skin and in a second orientation.

Example 72 may include the system of example 71, wherein the control module includes an accelerometer, and wherein the accelerometer is to determine a direction of the device to determine the first direction and the second direction.

Example 73 may include the system of example 67, wherein the first vector extends between the first electrode and the second electrode, wherein the potential is a first potential, wherein the disturbance is a first disturbance, and wherein the device further comprises a third electrode coupled to the first extension of the device and closer to a bottom of the device than the first electrode, the third electrode applying a second potential to the subject skin, and a fourth electrode coupled to the second extension of the device and closer to the bottom of the device than the second electrode, the fourth electrode detecting a second disturbance caused by the applied second potential, wherein the second vector extends between the third electrode and the fourth electrode, the second vector being separate from the first vector.

Example 74 may include an apparatus for capturing measurements related to the health of a subject, comprising: one or more sensors located on the subject, and one or more measurement modules coupled to the one or more sensors, the one or more measurement modules configured to cause a first portion of the one or more sensors to detect thoracic impedance of a portion of the subject, cause a second portion of the one or more sensors to detect heart sounds of the subject, generate a representation of the detected thoracic impedance, and generate a representation of the detected heart sounds.

Example 75 may include the apparatus of example 74, wherein the one or more measurement modules are further to fuse the detected chest impedance characterization with the detected heart sound characterization to produce fused data, and to provide the fused data to a cloud system for analysis.

Example 76 may include the apparatus of example 74, wherein the one or more sensors comprise one or more electrodes and a sound sensor.

Example 77 may include the apparatus of example 74, wherein the one or more measurement modules include connection switching circuitry to selectively couple other ones of the one or more measurement modules to the one or more sensors to detect the chest impedance and detect the heart sounds.

Example 78 may include a base station for storing a device for measuring a health characteristic of a subject, comprising a housing for mounting the device for storage, and electronics within the housing for retrieving data from the device when coupled to the device, and providing the data to a cloud system for analysis.

Example 79 may include the base station of example 78, wherein the housing has a contoured portion to accommodate the device for storage.

Example 80 may include the base station of example 79, wherein the housing comprises a first workpiece and a second workpiece connected to the first workpiece by a hinge, wherein the contoured portion is located within the first workpiece, and wherein the second workpiece rotates about the hinge against the first workpiece to enclose the device within the housing.

Example 81 may include the base station of example 79, wherein the electronic device includes a connector adjacent to the contoured portion, wherein the connector couples the electronic device to the device when the device is located in the contoured portion.

Example 82 may include the base station of example 78, wherein the electronic device includes one or more indicators, wherein the one or more indicators are to indicate when the electronic device is to retrieve data from the device and when the electronic device is to provide data to the cloud system.

Example 83 may include the base station of example 78, wherein the electronic device further comprises a connection port located on a surface of the housing, wherein the connection port facilitates coupling of the electronic device to the device.

Example 84 may include the base station of example 78, wherein the base station further comprises an arm coupled to the housing, wherein the arm extends along a surface of the housing, and wherein the device is retained between the arm and the surface of the housing when the device is mounted to the housing.

Example 85 may include the base station of example 84, wherein the arm includes an offset portion, wherein the offset portion is to contact the device when the device is mounted to the housing and to apply pressure to the device to maintain a position of the device when the device is mounted to the housing.

Example 86 may include the base station of example 78, wherein the electronic device further charges the device when the device is coupled to the electronic device.

Example 87 may include the base station of example 78, further comprising a cover rotatably coupled to the housing, wherein the cover rotates between a first position and a second position, wherein the cover is part of the device when the device is mounted to the housing and the cover is in the first position, and wherein the cover is to support the housing on a surface when the housing is placed on the surface and the cover is in the second position.

Example 88 may include a positioning guide for a wearable device for measuring a health characteristic of a subject, comprising: a first portion positioned around the neck of the subject, the first portion for supporting a guide around the neck of the subject when positioned around the neck of the subject, and a second portion at an end of the guide opposite the first portion for engaging with the wearable device to indicate the proper position of the wearable device on the subject.

Example 89 may include the guide of example 88, wherein the first portion comprises a neck piece positioned about a neck of the subject, wherein the second portion comprises a positioning piece, wherein the neck piece comprises a first mounting portion and the positioning piece comprises a second mounting portion for adjustably mounting the positioning piece to the first mounting portion of the positioning piece, and wherein a position at which the second mounting portion is mounted to the first mounting portion can be adjusted to provide a proper location for a wearable device on the subject.

Example 90 may include the guide of example 89, wherein an edge of the positioning workpiece is to abut against a portion of the wearable device to indicate a proper position of the wearable device on the object.

Example 91 may include the guide of example 89, wherein the neck workpiece includes a first positioning element on a first side of the neck workpiece and a second positioning element on a second side of the neck workpiece, the second side opposite the first side, wherein the first positioning element is for contacting a first portion of the neck of the subject and the second positioning element is for contacting a second portion of the neck of the subject such that the neck workpiece is centered about the neck of the subject.

Example 92 may include the guide of example 88, wherein the first portion includes a hook, wherein the second portion includes a socket, wherein the socket is located at an end of the guide opposite the hook, and wherein the socket is for engaging a portion of the wearable device to indicate the proper location of the wearable device on the object.

Example 93 may include one or more computer-readable media having instructions stored thereon, wherein the instructions, when executed by a computer device, cause the computer device to determine one or more health features of the subject, the one or more health features being determined from measurements captured by the subject, compare the one or more health features to a threshold value corresponding to one or more health warnings, and determine whether to display an attention indicator using an indicator of a subject in a list of subjects based on the comparison of the one or more health features to the threshold value.

Example 94 may include the one or more computer-readable media of example 93, wherein determining whether to display an attention indicator comprises determining to display an attention indicator based on a comparison of the one or more health characteristics to the threshold, and wherein the instructions further cause the computer device to display the list of objects on a display of the computer device using an attention indicator through the indicators of the objects.

Example 95 may include the one or more computer-readable media of example 94, wherein the instructions, when executed by the computer device, further cause the computer device to display the attention indicator based on a determination to display the indicator of the object at a top of the list of objects.

Example 96 may include the one or more computer-readable media of example 93, wherein the measurements captured from the subject include thoracic impedance of one or more heart sounds of the subject or a portion of the subject's body.

Example 97 may include the one or more computer-readable media of example 93, wherein the instructions, when executed by the computer device, further cause the computer device to perform user authentication of a user of the computer device, wherein the list of objects comprises objects associated with a user authentication result.

Example 98 may include the one or more computer-readable media of example 93, wherein the instructions, when executed by the computer device, further cause the computer device to detect user interaction with the indicator of the subject when displayed on a display of the computer device, and display at least a portion of the one or more health features on the display of the computer device in response to the detection of the user interaction.

Example 99 may include one or more computer-readable media having instructions stored thereon that, when executed by a computer device, cause the computer device to identify a display action indicated by an input of a user of the computer device, identify one or more features of the user input, identify one or more thresholds entered by the user, each of the one or more thresholds corresponding to a corresponding feature of the one or more features, and generate one or more equations based on the one or more features and the one or more thresholds, wherein the display action is to be performed when at least a portion of the one or more equations are satisfied.

Example 100 may include the one or more computer-readable media of example 99, wherein the instructions, when executed by the computer device, further cause the computer device to identify one or more relationships entered by a user, the one or more relationships corresponding to the one or more features and defining a relationship corresponding to one or more thresholds of the one or more features, wherein the one or more equations are further based on the one or more relationships.

Example 101 may include the one or more computer-readable media of example 99, wherein the instructions, when executed by the computer device, further cause the computer device to utilize the health feature to determine whether at least a portion of the one or more equations are satisfied, and in response to the determination that at least a portion of the one or more equations are satisfied, perform a display action.

It will be appreciated by those of ordinary skill in the art that modifications and variations can be made to the above-described systems, apparatuses and methods without departing from the inventive concepts disclosed herein. Accordingly, the application should not be considered as limited to the scope and spirit of the appended summary of important aspects.

Claims

1. A guide for positioning a wearable device for measuring a health characteristic of a subject, comprising:

A first portion positioned around the neck of the subject, the first portion for supporting a guide around the neck of the subject when positioned around the neck of the subject; and

A second portion at an end of the guide opposite the first portion for engagement with the wearable device to indicate the proper position of the wearable device on the subject.

2. The guide of claim 1, wherein the first portion comprises a neck workpiece positioned about a neck of the subject, wherein the second portion comprises a positioning workpiece, wherein the neck workpiece comprises a first mounting portion and the positioning workpiece comprises a second mounting portion for adjustably mounting the positioning workpiece to the first mounting portion of the positioning workpiece, and wherein a position at which the second mounting portion is mounted to the first mounting portion can be adjusted to provide a proper position on the subject for a wearable device.

3. The guide of claim 2, wherein an edge of the positioning workpiece is configured to abut against a portion of the wearable device to indicate the proper position of the wearable device on the object.

4. The guide of claim 2, wherein the neck piece includes a first positioning element on a first side of the neck piece and a second positioning element on a second side of the neck piece, the second side opposite the first side, wherein the first positioning element is for contacting a first portion of the neck of the subject and the second positioning element is for contacting a second portion of the neck of the subject such that the neck piece is centered around the neck of the subject.

5. The guide of claim 1, wherein the first portion comprises a hook, wherein the second portion comprises a socket, wherein the socket is located toward an end of the guide opposite the hook, and wherein the socket is for engaging a portion of the wearable device to indicate the proper position of the wearable device on the subject.

6. An apparatus for non-invasively detecting and monitoring medical conditions using a plurality of sensing modalities, the apparatus comprising:

at least two electrodes configured to be positioned on an object;

an acoustic sensor configured to be positioned on the object;

A thoracic impedance measurement module connected to the at least two electrodes for measuring a first impedance between the at least two electrodes; and

And the heart sound measuring module is connected with the acoustic sensor and used for detecting and measuring heart sounds from the acoustic sensor.

7. The apparatus of claim 6, further comprising a sensor for determining the orientation of the apparatus.

8. The device of claim 7, wherein the thoracic impedance measurement module measures a first impedance when the device is in a first orientation and a second impedance between the at least two electrodes when the device is in a second orientation.

9. The apparatus of claim 8, wherein the first direction indicates that the apparatus is approximately horizontal, and wherein the second direction indicates that the apparatus is angled relative to a horizontal plane.

10. The apparatus of claim 6, wherein the thoracic impedance measurement module automatically measures the first impedance at regular intervals.

11. The apparatus of claim 6, further comprising an electrocardiogram measurement module connected to the at least two electrodes for measuring electrical activity between the at least two electrodes.

12. The apparatus of claim 6, wherein the acoustic sensor is one of an ultrasonic sensor and a piezoelectric microphone.

13. The apparatus of claim 6, wherein the at least two electrodes comprise two electrode pairs, each electrode pair comprising a force electrode configured to apply a current to the object and a sense electrode configured to sense a change caused by the applied current.

14. The apparatus of claim 6, wherein the heart sound is an S3 heart sound.

15. A system for non-invasively detecting and monitoring medical conditions using a plurality of sensing modalities, the system comprising:

an apparatus for positioning on an object, the apparatus comprising:

A plurality of surface sensors; and

A plurality of sensing modules connected to the plurality of surface sensors, configured to collect multi-modal sensing data, wherein the multi-modal sensing data includes a first impedance between at least two of the surface sensors, and heart sounds from at least one of the plurality of surface sensors; and

A data analyzer operable to perform at least one of data analysis, data trend analysis, and data restoration of the multimodal sensory data.

16. The system of claim 15, further comprising a data decision engine configured to combine at least some of the multi-modal sensed data, wherein the combined multi-modal sensed data is indicative of a state of a medical condition of the subject.

17. The system of claim 16, further comprising a transceiver configured to transmit the combined multi-modal sensed data to the cloud over at least one wireless communication path for further processing.

18. The system of claim 15, wherein the device further comprises a sensor for determining the orientation of the device.

19. The system of claim 18, wherein the device comprises a chest impedance measurement module configured to measure the first impedance when the device is in a first orientation and to measure a second impedance between at least two of the surface sensors when the device is in a second orientation.

20. The system of claim 15, wherein the apparatus further comprises an electrocardiogram measurement module connected to the plurality of surface sensors for measuring electrical activity between at least two of the surface sensors.

21. The system of claim 15, wherein the surface sensor comprises at least one of an electrode, a heart sound sensor, an ultrasonic sensor, and a photoplethysmographic sensor.

22. A guide for positioning a device on an object, comprising:

A neck workpiece positioned around a neck of the subject; and

A workpiece is positioned having an indication portion that indicates the proper position of the device on the object when the neck workpiece is positioned around the neck of the object.

23. The guide of claim 22, wherein the neck piece comprises a necklace portion having an annular shape with a hollow center, and wherein the neck of the subject is positioned within the hollow center of the necklace portion when the neck piece is positioned around the neck of the subject.

24. The guide of claim 23, further comprising:

a first positioning element coupled to the necklace portion; and

A second positioning element coupled to the necklace portion, wherein the first positioning element and the second positioning element extend inwardly from the necklace portion, and wherein the first positioning element and the second positioning element contact the neck of the subject when the neck piece is positioned around the neck of the subject to facilitate positioning of the necklace portion.

25. The guide of claim 24, wherein the first positioning element is coupled to a first side of the necklace portion and the second positioning element is coupled to a second side of the necklace portion opposite the first side of the necklace portion.

26. The guide of claim 22, wherein a positioning workpiece is adjustably coupled to the neck workpiece.

27. The guide of claim 26, wherein the neck workpiece comprises a mounting portion, wherein the positioning workpiece comprises a mounting portion, and wherein the mounting portion of the neck workpiece couples the mounting portion of the positioning workpiece to couple the positioning workpiece to the neck workpiece.

28. The guide of claim 22, wherein the indicating portion includes locating an edge of the workpiece, and wherein the indicating portion indicates that the device is positioned proximate the edge to obtain the proper position.