Electronic components of a physiological monitoring device

Abstract

This disclosure relates to an apparatus configured to adhere to the surface of a mammal to record physiological signals, and a related system / method. The apparatus may include a housing surrounding a circuit board and flexible wings extending from the housing. The apparatus may include electrodes coupled to the flexible wings and electrical traces for transmitting electrical signals between the electrodes and the circuit board. The electrical traces may have an insulator with a conductive material and resistors printed on the surface of the insulator. The trace layer may include conductive vias for transmitting signals from the bottom to the top of the trace layer. The housing may include a battery with a battery terminal connector configured to provide electrical pathways to two terminals on one side of the battery. The housing may include a floating trigger button.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 062,314, filed August 6, 2020, the entire contents of which are incorporated herein by reference. Background of the Invention

[0004] For the purposes of this disclosure, certain aspects, advantages, and novel features of various embodiments are described herein. It should be understood that not all of these advantages will necessarily be achieved according to any particular embodiment. Therefore, various embodiments may be implemented in a manner that achieves one or a set of advantages taught herein, and not necessarily other advantages that may be taught or suggested herein. Technical Field

[0005] This document discloses materials, apparatus, methods, and systems for monitoring physiological signals. For example, such physiological signals may include cardiac signals, such as electrocardiogram (ECG) signals. Background Technology

[0006] Abnormal heart rhythms or arrhythmias can cause a variety of symptoms, such as loss of consciousness, palpitations, dizziness, and even death. Arrhythmias causing these symptoms are often a sign of serious underlying heart disease. Because these problems can be successfully improved and significant symptoms and death prevented through various procedures such as pacemaker implantation or percutaneous catheter ablation, it is crucial to identify when these symptoms are caused by a heart rhythm abnormality. For example, monitors such as Holter monitors and similar devices are currently used to monitor heart rhythm. Summary of the Invention

[0007] The embodiments described herein relate to a physiological monitoring device that can be worn continuously and comfortably by human or animal subjects for at least one week or longer, and more typically two to three weeks or longer. In one embodiment, the device is specifically designed to sense and record heart rhythm (e.g., electrocardiogram, ECG) data, but in various alternative embodiments, one or more additional physiological parameters may also be sensed and recorded. Such physiological monitoring devices may include numerous features for promoting and / or improving the patient experience and for more accurate and timely diagnosis of arrhythmias.

[0008] In some embodiments, an electronic device for monitoring physiological signals of a mammal includes: at least two flexible wings extending laterally from a housing, wherein the flexible wings include a first set of materials enabling the wings to conform to the surface of a mammal and the housing includes a second set of materials; a printed circuit board assembly housed within the housing, wherein the housing is configured to prevent the printed circuit board from deforming due to movement of the mammal; at least two electrodes embedded within the flexible wings, the electrodes being configured to provide conformal contact with the surface of the mammal and detect physiological signals of the mammal; at least two electrode traces embedded within the wings and mechanically separated from the housing, the electrode traces being configured to provide conformal contact with the surface of the mammal and transmit electrical signals from the electrodes to the printed circuit board assembly; and at least one hinge connecting the wings to the housing, the hinge being configured to be freely bent in the region connected to the housing.

[0009] In some embodiments, each wing may include an adhesive. In some embodiments, the electrodes may be in the same plane as the adhesive. In some embodiments, each wing includes at least one edge, wherein the edge is thinner than the adjacent portion of each wing. The housing may further include a dimple or groove configured to allow airflow between the housing and the mammalian surface. In some embodiments, the edge is configured to prevent a portion of the wing from detaching from the mammalian surface. In some embodiments, the electronics for monitoring physiological systems may include a measuring instrument configured to detect motion signals on at least one axis. The measuring instrument may be an accelerometer, which may be configured to detect motion signals on three axes.

[0010] In some embodiments, motion signals can be collected in real time along with physiological signals. In some embodiments, motion artifacts can be identified when physiological and motion signals match. Further embodiments may require an event trigger coupled to a printed circuit board assembly. In some embodiments, the event trigger input is supported or floated on a shock absorber such as a spring or foam to prevent mechanical stress on the printed circuit board when the trigger is activated, which in turn can reduce the source of artifact in the recorded signal.

[0011] In some embodiments, the event trigger may be concave or convex and larger than a human finger for easy positioning. In other embodiments, the event trigger may be convex within a concave area. In some embodiments, the electrode traces are configured to minimize signal distortion during mammalian movement. In certain embodiments, a gasket may be used as a tool for hermetically attaching to a housing.

[0012] In some embodiments, a method for monitoring physiological signals in mammals may include: attaching an electronic device to a mammal, wherein the device includes: at least two electrodes configured to detect physiological signals from the mammal, at least one measuring instrument configured to detect secondary signals, and at least two electrode traces connected to the electrodes and a housing; and comparing the physiological signals with the secondary signals to identify artifacts.

[0013] In some embodiments, artifact identification includes a comparison between the spectrum of the physiological signal and the spectrum of the secondary signal. In embodiments, the secondary signal includes motion signals that can be used to derive the mammal's activity and position. In some embodiments, the secondary signal is collected on three axes. In some embodiments, a ternary signal may also be collected. In some embodiments, the secondary signal includes information about the connection between the electronic device and the mammal. In some embodiments, the secondary signal can be used to detect when the mammal is sleeping.

[0014] In some embodiments, a method for removing and replacing portions of a modular physiological monitoring device may include: applying the device to a mammal for more than 7 days and collecting physiological data; using the device to detect a first set of physiological signals; removing the device from the surface of the mammal; removing a first component from the device; and incorporating the first component into a second physiological monitoring device configured to detect a second set of physiological signals.

[0015] In some embodiments, the first component is electrically connected to other device components without using a permanent connection. In some embodiments, the device may further include a spring connection. In some embodiments, the first component can be stored in a housing for secondary use to prevent damage. In a particular embodiment, the first component is secured within the device by a mechanism capable of re-secured to the second component after the first component is removed.

[0016] Some embodiments may relate to systems for inferring heart rhythm information based on time-series data of heartbeat intervals obtained, for example, from consumer wearable devices or medical device products. Others relate to improvements to the system to enable more robust and / or more timely inference of heart rhythm information by using additional data sources. This additional data may include summary statistics or specific signal characteristics derived from an ECG, time-series data of user activity derived from an accelerometer, information related to user status, or information related to the date / time of recording.

[0017] In some embodiments, a system for selectively transmitting electrocardiogram (ECG) signal data from a wearable medical sensor, wherein the QRS (Quadrature Reflectance) refers to three reference points of the ECG recorded during ventricular depolarization, may include:

[0018] A wearable medical sensor that includes a QRS detector that generates a real-time estimate of the location of each R peak in an ECG;

[0019] According to a predefined schedule, the RR interval time series, along with the start timestamp, is transmitted from the sensor to a smartphone or an internet-connected gateway device.

[0020] The RR interval time series and start timestamp are transmitted from a smartphone or internet-connected gateway device to the server;

[0021] Based on the RR interval time series data, the server-side algorithm infers the most likely heart rhythm and its onset / offset time;

[0022] The list of inferred heart rhythms is filtered according to specific filtering criteria, so that only inferred heart rhythms that meet the given criteria are retained after filtering.

[0023] The start / end time of each remaining heart rhythm after filtering is transmitted from the server to a smartphone or an internet-connected gateway device.

[0024] The start / end time of each remaining heart rhythm after filtering is transmitted from a smartphone or internet-connected gateway device to the wearable sensor;

[0025] The recorded ECG portion, corresponding to each start-end time pair, is transmitted from the sensor to a smartphone or an internet-connected gateway device.

[0026] The recorded ECG portions, corresponding to each start-end time pair, are transmitted from a smartphone or internet-connected gateway device to the server.

[0027] Heart rhythm filtering criteria can be specified by a physician or other medical professional before the patient uses the wearable sensor. In other embodiments, the heart rhythm filtering criteria are dynamic and can be updated according to predefined rules during system use. In some embodiments, these predefined rules may describe adjustments to the filtering criteria based on previous findings during system use. In some embodiments, the start and end times of each inferred heart rhythm may be adjusted such that the duration of each heart rhythm is less than a given maximum permissible duration. The calculated confidence level may be input to the heart rhythm filtering criteria. In some embodiments, the system includes inferring heart rhythm information based on RR interval time series data. In some embodiments, the heart rhythm inference system is implemented as a cloud service accessible via an API.

[0028] In some embodiments, the heart rhythm estimation system is provided through a software library that can be incorporated into a standalone application. The RR interval value can be estimated based on the photoplethysmography (PPG) signal.

[0029] In some embodiments of the method for inferring heart rhythm information, the heart rhythm inference system calculates a confidence score for each type of heart rhythm, the method comprising:

[0030] Calculate the frequency and duration of each heart rhythm type inferred from a set of RR interval time series data for a given user;

[0031] Estimate the confidence statistic for each heart rhythm type based on the inferred frequency and duration of the central rhythm from a set of RR interval time series for a given user;

[0032] Evaluate whether the confidence statistic for each inferred heart rhythm exceeds a predetermined threshold;

[0033] The heart rhythm information is provided back to the recall software only for inferred heart rhythms whose confidence statistic exceeds a threshold;

[0034] In some embodiments, the heart rhythm inference system accepts additional data sources including one or more of the following:

[0035] User activity time-series data measured by accelerometers;

[0036] Specific date and time information for each RR interval time series record;

[0037] Information regarding the user's age, gender, clinical indications for monitoring, past medical history, medication information, and medical history;

[0038] ECG signal characteristics and summary statistics, such as the mean, median, standard deviation, or sum of ECG signal sample values ​​within a given time period;

[0039] The measuring device provides a confidence level for indicating, for example, the quality of heartbeat estimates for each heartbeat or a continuous period of time; and

[0040] Internal runout interval measurement.

[0041] In one embodiment, a system for monitoring cardiac signal data includes:

[0042] A wearable medical sensor configured to detect signals from the heart of a mammal and estimate the location of the R-peak within the heart signal;

[0043] The wearable medical sensor is configured to send RR interval time series and timestamps to an intermediate device, which is configured to further send the RR interval time series and timestamps to a server.

[0044] The server is configured to infer the most likely heart rhythm and its start / end time based on the RR interval time series and timestamps, and the server is configured to filter the most likely heart rhythm according to a first criterion into a filtered dataset.

[0045] The server is configured to send filtered datasets back to the wearable sensor via an intermediary device; and

[0046] The sensor sends full-resolution heart signals to the server within each enclosed time period of the filtered event.

[0047] In some embodiments, a system for monitoring cardiac signal data includes:

[0048] The server is configured to communicate with a wearable sensor that is configured to detect signals from the heart of a mammal and estimate the location of the R-peak within the heart signal.

[0049] The wearable sensor is configured to send RR interval time series and timestamps to a server;

[0050] The server is configured to infer the most probable heart rhythm and its start / end time based on the RR interval time series and timestamps. The server is also configured to filter the most probable heart rhythm according to a first criterion into a filtered dataset.

[0051] The server is configured to send aggregated filtered data.

[0052] In a particular embodiment, a server for monitoring cardiac signal data includes:

[0053] A portal is configured to communicate with a wearable sensor configured to detect cardiac signals from mammals and estimate the location of R peaks within the cardiac signals. The wearable sensor is configured to send RR interval time series and timestamps to an intermediate device, which is configured to further send the RR interval time series and timestamps to a server.

[0054] A processor, configured to infer the most probable heart rhythm and its start / end time based on the RR interval time series and timestamps, is configured to filter the most probable heart rhythm into a filtered dataset according to a first criterion; and

[0055] The server is configured to send a summary of the filtered dataset.

[0056] In one embodiment, a non-transitory storage medium storing computer-executable instructions is provided. These computer-executable instructions are readable by a computing system comprising one or more computing devices, wherein the computer-executable instructions are executable on the computing system to cause the computing system to perform the following operations: receiving physiological sensor data generated by a patient monitoring device and associated with a first patient via a communication link; analyzing the physiological sensor data to determine whether one or more points in the physiological data may indicate a set of or more predetermined conditions; and, after determining that at least one of the one or more points in the physiological data may indicate at least one of a set of or more predetermined conditions, generating an electronic data packet for transmission to the patient monitoring device, the electronic data packet including location data regarding at least one of the one or more points in the physiological sensor data, which may indicate at least one of a set of or more predetermined conditions.

[0057] In some embodiments, the physiological sensor data may include samples of interval data measured from the recorded signal data, the sample size of which is smaller than the recorded signal data.

[0058] In a particular embodiment, a system for monitoring physiological signals in mammals may include: a wearable adhesive monitor configured to detect and record heart rhythm data from the mammal, the wearable adhesive monitor being configured to extract features from the heart rhythm data; wherein the wearable adhesive monitor is configured to send the features to a processing device configured to analyze the features, identify locations of interest, and send the locations of interest back to the wearable adhesive monitor.

[0059] In some embodiments, a system for evaluating physiological sensor data from a patient monitoring device includes: a computer processor and a non-transitory computer-readable medium combined with the computer processor, the computer processor being configured to provide a program including a set of instructions stored on a first server, and further configured to execute a sensor data inference module of the program, the set of instructions being executable by the computer processor; the sensor data inference module of the program storing instructions to: receive physiological sensor data generated by the patient monitoring device, the physiological sensor data being associated with a first patient; analyze the physiological sensor data to determine whether one or more points in the physiological data may indicate a set of or more predetermined conditions; and, after determining that at least one of the one or more points in the physiological data may indicate at least one of a set of or more predetermined conditions, generate an electronic data packet for transmission to the patient monitoring device, the electronic data packet including location data regarding at least one of the one or more points in the physiological sensor data, the at least one of the one or more points possibly indicating at least one of a set of or more predetermined conditions.

[0060] In some embodiments, a computerized method may include: accessing computer-executable instructions from at least one computer-readable storage medium; and executing the computer-executable instructions to cause computer hardware including at least one computer processor to perform the following operations: receiving physiological sensor data generated by a patient monitoring device and associated with a first patient via a communication link by a server computer; analyzing the physiological sensor data by the server computer to determine whether one or more points in the physiological data may indicate a set of or more predetermined conditions; and after determining that at least one of the one or more points in the physiological data may indicate at least one of a set of or more predetermined conditions, generating an electronic data packet for transmission to the patient monitoring device, the electronic data packet including location data regarding at least one of the one or more points in the physiological sensor data, which may indicate at least one of a set of or more predetermined conditions.

[0061] These and other aspects and embodiments of the invention are described in more detail below with reference to the accompanying drawings. Attached Figure Description

[0062] Figure 1A and Figure 1B These are, respectively, a perspective view and an exploded outline view of a physiological monitoring device according to one embodiment.

[0063] Figure 2A and Figure 2B These are top and bottom perspective views of a printed circuit board assembly of a physiological monitoring device according to one embodiment.

[0064] Figure 3A , Figure 3B , Figure 3C , Figure 3D and Figure 3E These are perspective and exploded views of the flexible body and gasket of a physiological monitoring device according to one embodiment.

[0065] Figure 4 This is an exploded view of the housing of a physiological monitoring device according to one embodiment.

[0066] Figure 5A and Figure 5B A perspective view of a battery holder for a physiological monitoring device according to one embodiment is provided.

[0067] Figure 6A and Figure 6B This is a cross-sectional view of a physiological monitoring device according to one embodiment.

[0068] Figure 7 This is an exploded view of a physiological monitoring device including multiple optional items according to one embodiment.

[0069] Figure 8A and Figure 8B The image is a perspective view of two people wearing physiological monitoring devices according to one embodiment, showing how the devices bend to conform to body movement and position.

[0070] Figure 9A , Figure 9B , Figure 9C , Figure 9D , Figure 9E and Figure 9F The illustration shows the various steps for applying a physiological monitor to a patient's body according to one embodiment.

[0071] Figures 10A to 10C An alternative example of a trace layer is illustrated schematically. Figure 10A The first example of a trace layer is shown, while Figure 10B Depicting Figure 10A A close-up of illustration A. Figure 10C Another example of a trace layer is shown.

[0072] Figures 11A to 11I An example of a battery terminal connector is illustrated schematically. Figure 11A The inner surface of a battery terminal connector configured to contact battery terminals is depicted, and Figure 11B Depicting and Figure 11A The surface depicted is the outer surface of the battery terminal connector opposite to the surface shown in the image. Figure 11C The inner surface of another example of a battery terminal connector configured to contact battery terminals is depicted, and Figure 11D Depicting and Figure 11C The surface depicted is the outer surface of the battery terminal connector opposite to the surface shown in the image. Figure 11E This diagram shows the outline of the battery to which the battery terminal connector is connected. Figure 11F and Figure 11G The inner surface of another example of a battery terminal connector configured to contact battery terminals is depicted. Figure 11H and Figure 11I Depicting and Figure 11C The surface depicted is the outer surface of the battery terminal connector opposite to the surface shown in the image.

[0073] Figures 12A to 12G A multi-view diagram showing another example of the upper shell. Figure 12A A partial exploded view of the upper shell is depicted. Figure 12B A three-dimensional view of the flexible upper frame is shown. Figure 12C The outline of the flexible upper frame is shown. Figure 12D A top view of the flexible upper frame is shown. Figure 12E A three-dimensional view depicting the inner surface of the upper shell is provided. Figure 12F The outlines of the upper and lower shells are depicted. Figure 12GThe outline of the ridges at the top and bottom of the casing is depicted.

[0074] Figures 13A to 13B A multi-view diagram showing another example of the lower housing. Figure 13A A three-dimensional view of the lower shell is depicted, while Figure 13B The outline of the lower shell is depicted.

[0075] Figures 14A to 14B An orthogonal profile diagram showing an example of a wave spring.

[0076] Figures 15A to 15I Multiple views showing another example of a physiological monitoring device. Figure 15A An exploded view of the physiological monitoring device is depicted. Figure 15B An exploded view of the physiological monitoring device is depicted. Figure 15C A silhouette of the shell with the upper shell removed is depicted. Figure 15D Describing as Figure 15C The diagram shown is a silhouette of the shell with the additional flexible upper frame removed. Figure 15E Describing as Figure 15D The diagram shows the outline of the shell with the additional flexible lower frame removed. Figure 15F Describing as Figure 15E The diagram shown shows the outline of the casing with the battery and spring removed. Figure 15G Describing as Figure 15F The cross-sectional view of the housing shown is taken between the circuit board 120 and the spring contact pad 632. Figure 15H Describing as Figure 15G The diagram shows a cross-sectional view of the housing with the additional spring contact pad removed. Figure 15I Describing as Figure 15H The diagram also shows the outline of the circuit board housing.

[0077] Figures 16A to 16D Several views illustrating embodiments of the physiological monitoring device are shown. Figure 16A Showing the top 3D view, Figure 16B Showing the bottom view, Figure 16C Showing a top perspective view including the lining, Figure 16D Showing a bottom view including the lining.

[0078] Figure 17A and Figure 17B Cross-sectional views of two examples of grinders are shown schematically. Figure 17A A grinder including a compressible spring is described. Figure 17B A polisher incorporating compressible foam is described.

[0079] Figure 18 A schematic diagram illustrating an embodiment of the heart rhythm inference service.

[0080] Figure 19 This is a schematic diagram of an embodiment of a system for extracting and transmitting data features from a physiological monitor. Detailed Implementation

[0081] The following description relates to several different embodiments. However, the described embodiments can be implemented and / or varied in many different ways. For example, the described embodiments can be implemented in any suitable device, apparatus, or system to monitor any one of a plurality of physiological parameters. For example, the following discussion focuses primarily on long-term patch-type heart rhythm monitoring devices. In an alternative embodiment, the physiological monitoring device can be used, for example, for pulse oximetry and the diagnosis of obstructive sleep apnea. The method of using the physiological monitoring device may also vary. In some cases, the device may be worn for a week or less, while in others, the device may be worn for at least seven days and / or more than seven days, such as fourteen to twenty-one days or even longer.

[0082] Many other alternative embodiments and applications of the described technology may exist. Therefore, the following description is provided for illustrative purposes only. Throughout this specification, the term "conformal" may be referenced. It will be understood by those skilled in the art that, as used herein, the term "conformal" refers to a relationship between surfaces or structures in which a first surface or structure conforms to the contour of a second surface or structure.

[0083] Because abnormal heart rhythms or arrhythmias can often be caused by other, less serious reasons, a key challenge is determining when any of these symptoms is caused by an arrhythmia. Often, arrhythmias occur rarely and / or sporadically, making rapid and reliable diagnosis difficult. As mentioned above, current heart rhythm monitoring is primarily accomplished using devices with short-term (less than one day) electrodes fixed to the chest, such as Holter monitors. Wires connect the electrodes to a recording device typically worn on a belt. Electrodes need to be changed daily, and the wires are cumbersome. These devices also have limited storage capacity and recording time. Wearing the device interferes with patient activity and often prevents patients from performing certain activities, such as bathing, while being monitored.

[0084] Furthermore, Holter monitors are fixed devices with limited availability, which often leads to supply constraints and corresponding testing delays. These limitations severely hinder the diagnostic utility of the device, patient adherence to its use, and the likelihood of capturing all essential information. Lack of adherence and the limitations of the device often necessitate additional devices, follow-up monitoring, or other tests to make a correct diagnosis.

[0085] Current methods for associating symptoms with the occurrence of arrhythmias, including the use of rhythm monitoring devices such as Holter monitors and cardiac event recorders, are generally insufficient for accurate diagnosis. In fact, Holter monitors have been shown to fail to lead to a diagnosis in up to 90% of cases (DE Ward et al., 1980, in Biotelemetry Patient Monitoring, Volume 7, entitled "Assessment of the Diagnostic Value of 24-Hour Ambulatory Electrocardiographic Monitoring").

[0086] Furthermore, the actual medical process of obtaining and initiating heart rate monitoring is often quite complex. Ordering, tracking, monitoring, retrieving, and analyzing data from such devices typically involves numerous steps. In most cases, heart rate monitoring devices used today are ordered by a cardiologist or cardiac electrophysiologist (EP) rather than the patient's primary care physician (PCP). This is crucial because the PCP is usually the first doctor to see the patient and determine that the patient's symptoms may be due to an arrhythmia. After the patient sees the PCP, the PCP schedules an appointment for the patient to see a cardiologist or EP. This appointment is usually several weeks after the initial PCP visit, which in itself can lead to potential delays in diagnosis and increase the likelihood of arrhythmias occurring undiagnosed. When the patient finally sees the cardiologist or EP, a heart rate monitoring device is usually ordered. The monitoring period can last 24 to 48 hours (Holter monitor) or up to a month (cardiac event monitor or mobile telemetry device). Once monitoring is complete, the patient usually has to return the device to the clinic, which is inconvenient in itself. After the monitoring company or on-site technicians at the hospital or office process the data, the report is eventually sent to the cardiologist or EP for analysis. This complex process results in fewer patients receiving heart rhythm monitoring than ideally would.

[0087] To address some of these problems in cardiac monitoring, the assignee of this application has developed several embodiments of a small, long-term, wearable, physiological monitoring device. One embodiment of this device is... Patches. For example, various embodiments are described in U.S. Patent Nos. 8,150,502, 8,160,682, 8,244,335, 8,560,046, and 8,538,503, the entire disclosure of which is incorporated herein by reference. Generally, the physiological patch-based monitors described in the foregoing references are comfortably worn on a patient's chest and are designed to be worn for at least one week, typically two to three weeks. The monitor continuously detects and records cardiac rhythm signal data while the device is worn, and this cardiac rhythm data can then be processed and analyzed.

[0088] These smaller, long-duration, patch-based physiological monitoring devices offer many advantages over existing technologies. However, further improvements are needed. One of the most significant areas for improvement is providing more timely notification of serious arrhythmias to managing clinicians. These initial embodiments are characterized—for performance, compliance, and cost reasons—by the device recording information only during the extended wearing period and analyzing and reporting only after recording is complete. Therefore, an ideal improvement would be to add the ability to perform real-time or timely analysis of the collected cardiac rhythm information. While diagnostic monitors with this timely reporting capability exist, they require periodic charging or replacement of one or more electrical components of the system. These actions reduce patient compliance and consequently, diagnostic rates. Thus, a key area for improvement is developing a physiological monitor that can combine long-duration recording with timely reporting without requiring battery charging or replacement.

[0089] Patient compliance and device adhesion are two factors controlling the duration of ECG recordings and thus diagnostic rates. Compliance can be improved by enhancing the patient's wearing experience, which is influenced by wearing comfort, device appearance, and the degree to which the device interferes with normal daily activities. Given that longer ECG recordings provide higher diagnostic rates and value, improvements in device adhesion and patient compliance are necessary.

[0090] Signal quality is important throughout wear, but may be even more critical at the point where the patient marks and records the data, indicating areas of clinical significance for symptoms. Marking and recording is most easily achieved via a trigger located on the outer surface of the device. However, because the trigger may be part of a skin contact platform with integrated electrodes, the patient may introduce noticeable motion artifacts as they fumble for it. The ideal device improvement is a symptom trigger that can be activated with minimal motion artifacts.

[0091] Furthermore, the device is expected to be simple and cost-effective to manufacture, enabling scalability during production and higher quality due to process repeatability. Simplicity in manufacturing also allows for easy disassembly, enabling efficient recycling of the printed circuit board for reuse in quality control within another device. Effective reuse of this expensive component is crucial for reducing the cost of diagnostic monitors.

[0092] There remain clinical scenarios where longer-lasting and less-cost solutions could be a valuable addition to the portfolio of cardiac dynamic monitoring options. Inspiration for potential solutions to these needs can be found in continuous heart rate sensing capabilities, increasingly being incorporated into various consumer health and fitness products, including smartwatches and wearable fitness trackers. While continuous heart rate data can be used to provide users with information about their overall health, providing meaningful information relevant to their health and wellness is more challenging and valuable. For example, the ability to detect potential arrhythmias from continuous heart rate data would make consumer devices with heart rate sensing capabilities potential screening tools for the early detection of cardiac abnormalities. This approach could have clinical value in providing a long-term, cost-effective screening method for high-risk populations, such as heart failure patients at risk of atrial fibrillation. Alternatively, this monitoring method could aid in the long-term titration of therapeutic drug dosages to ensure efficacy while minimizing side effects, such as in the treatment of paroxysmal atrial fibrillation. Beyond arrhythmia detection, appropriate analysis of heart rate information can also provide insights into sleep and stress applications.

[0093] Long-term dynamic monitoring using physiological devices such as patches has a variety of clinical applications, particularly when it can provide timely information about the occurrence and duration of observed arrhythmias during the monitoring period. In terms of prevalence, especially driven by an aging population, effective detection of atrial fibrillation (AF) remains the most important monitoring need. This need is evident not only for symptomatic patients but also for broader, population-based monitoring of asymptomatic AF in individuals at risk due to one or more of the factors associated with this arrhythmia, such as advanced age, pre-existing chronic conditions like heart disease, or previous surgery, given the increased risk of stroke associated with this arrhythmia. For the latter group, perioperative and postoperative monitoring is clinically valuable not only for procedures aimed at arrhythmia prevention (e.g., MAZE ablation or mixed endocardial and epicardial procedures used to treat AF) but also for routine procedures involving anesthesia. For some applications, the goal of dynamic monitoring of atrial fibrillation sometimes focuses on a simple binary question: whether AF actually occurs within a given time period. For example, monitoring patients after ablation is often to confirm success, which is typically defined as the complete absence of AF. Similarly, monitoring post-stroke patients will primarily involve assessing the presence of atrial fibrillation.

[0094] However, even in those cases, if AF occurs, assessing other aspects to better characterize the occurrence may be clinically significant, such as daily burden (percentage of AF time per day) and episode duration (e.g., represented by a histogram of episode duration, or by the percentage of episodes exceeding a specified limit, such as six minutes), whether in absolute values ​​or compared to previous benchmarks (e.g., from baseline, preoperative monitoring results). In fact, measuring daily AF burden, assessing AF episode duration, reviewing AF occurrences during sleep and wakefulness, and evaluating the presence of AF based on the patient's level of physical activity are important for a variety of clinical situations, including evaluating the effectiveness of medication-based treatment for this arrhythmia.

[0095] Providing this information promptly during monitoring allows treating physicians to repeatedly titrate treatment, for example, by adjusting the dosage and frequency of novel oral anticoagulants (NOACs) until the treatment is optimized. Another example of this treatment modality is notifying patients of asymptomatic AF—directly via a device through an audible or vibrating alarm, through a notification from an app connected to the device, or via communication from the treating clinician by phone, email, or text message—to promptly apply a "pill in the pocket" for AF treatment.

[0096] The importance of timely treatment and / or intervention is evident in cases of clinically significant arrhythmias, such as asymptomatic second-degree and complete myocardial infarction, prolonged pauses, high-rate supraventricular tachycardia, prolonged ventricular tachycardia, and ventricular fibrillation. For example, the clinical situation of prolonged pauses or complete myocardial infarction leading to syncope is particularly important, where the availability of timely and reliable monitoring methods can reduce or even eliminate the need for inpatient monitoring of high-risk patients. This topic can also be extended to more subtle morphological changes, such as prolonged QT response to medications, which has been shown to have significant implications for cardiac safety. Timely recognition of such prolongation may lead to, for example, premature termination of clinical studies evaluating the safety and efficacy of the drug, or adjustment of the dosage or frequency as a means of eliminating the observed prolongation.

[0097] Physiological monitoring device

[0098] Reference Figure 1A and Figure 1B A perspective view and an exploded outline view of one embodiment of the physiological monitoring device 100 are provided. Figure 1AAs shown, the physiological monitoring device 100 may include a flexible body 110 coupled to a waterproof housing 115. As those skilled in the art will understand, the housing described herein and throughout this specification may be constructed of rigid or flexible materials, such that the housing is, for example, rigid to resist deformation, or, for example, flexible to bend and / or deform under force. The flexible body 110 (which may be referred to as a “flexible substrate” or “flexible construction”) typically includes two wings 130, 131 extending laterally from the housing 115 and two flexible electrode traces 311, 312, each of which is embedded in one of the wings 130, 131. Each electrode trace 311, 312 is coupled to a flexible electrode (on the bottom surface of the flexible body 110) with respect to the flexible electrode (on the bottom surface of the flexible body 110). Figure 1A (Not visible in the center) Connection. Electrodes are configured to sense heart rhythm signals from a patient to whom the monitoring device 100 is attached. Electrode traces 311, 312 then transmit those signals to electronics housed in the housing 115. Figure 1A (Not visible in the image). The housing 115 also typically contains a power source, such as one or more batteries.

[0099] The combination of a highly flexible body 110, including flexible electrodes and electrode traces 311, 312, and a housing 115, offers numerous advantages. A key advantage is high-fidelity signal capture. The highly conformal flexible wings 130, 131, electrodes, and traces 311, 312 restrict external energy transfer to the electrode-skin interface. For example, if the housing 115 moves, the conformally adhered system to the skin limits the extent to which that movement affects the monitoring signal. The flexible electrode traces 311, 312 can generally help provide conformal contact with the subject's skin and can help prevent electrode 350 (not visible in Figure 1, but described below) from being moved. Figure 6A The flexible body 110 is peeled or lifted off the skin (as can be seen in the image), thereby providing strong motion artifact suppression and better signal quality by minimizing the stress transmitted to the electrode 350. Furthermore, the flexible body 110 includes constructions and various features that facilitate comfortable wear of the device 100 by the patient for fourteen (14) days or longer without removal. The housing 115, which is not typically adhered to the patient in the embodiments described herein, includes features that contribute to the comfort of the device 100. Hinges 132 are relatively thinner, or even more flexible, portions of the flexible body 110. They allow the flexible body 110 to bend freely in the area where it connects to the housing 115. This flexibility enhances comfort because the housing 115 can be freely lifted off the patient's skin as the patient moves. The electrode traces 311, 312 are also very thin and flexible to allow the patient to move without causing signal distortion.

[0100] Now refer to Figure 1BThe partially exploded view of the physiological monitoring device 100 shows in more detail the constituent components that constitute and are contained within the housing 115. In this embodiment, the housing 115 includes an upper housing member 140 that is detachably coupled to a lower housing member 145. Sandwiched between the upper housing member 140 and the lower housing member 145 are an upper washer 370 and a lower washer 360 (in... Figure 1B (Not visible above but directly below the upper gasket 370). Gaskets 370 and 360 help to waterproof the housing members and / or body 115 when assembled. Multiple components of the monitoring device 100 may be accommodated between the upper housing member 140 and the lower housing member 145. For example, in one embodiment, the housing 115 may include a portion of the flexible body 110, a printed circuit board assembly (PCBA) 120, a battery holder 150, and two batteries 160. The PCBA assembly 120 is located within the housing 115 to contact electrode traces 311, 312 and the batteries 160. In various embodiments, one or more additional components may be included within or attached to the housing 115. Some of these optional components are further described below with reference to the accompanying drawings.

[0101] According to various alternative embodiments, the battery holder 150 may accommodate two batteries (as in the illustrated embodiment), one battery, or more than two batteries. In other alternative embodiments, other power sources may be used. In the illustrated embodiment, the battery holder 150 includes a plurality of retaining tabs and / or lugs 153 for accommodating the battery 160 within the battery holder 150. Furthermore, the battery holder 150 includes a plurality of legs and / or lugs 152 to properly space the battery 160 from the PCBA 120 surface and ensure proper contact with the spring contacts and / or contacts 235 and 236. In this embodiment, spring contacts 235 and 236 are used instead of soldering the battery 160 to the PCBA 120. Although soldering may be used in alternative embodiments, one advantage of the spring contacts 235 and 236 is that they allow the battery 160 to be removed from the PCBA 120 and the battery holder 150 without damaging any of those components, thus allowing for multiple reuses of both. Eliminating soldered connections also simplifies and speeds up the assembly and disassembly of the monitoring device 100.

[0102] In some embodiments, the upper housing member 140 can act as a patient event trigger. When a patient wears the physiological monitoring device 100 for heart rhythm monitoring, it is generally advantageous for the patient to be able to register (e.g., log into the device's memory) any cardiac events perceived by the patient with the device 100. For example, if a patient feels what he / she perceives as an arrhythmia, the patient can trigger the device 100 in some way and thus provide a recording of the perceived event. In some embodiments, triggering a patient-perceived event can initiate the transmission of data associated with the triggered event. In some embodiments, triggering a perceived event can simply mark consecutive recordings by the location of the triggering event. In some embodiments, both the transmission of relevant data and the marking of consecutive recordings may occur. At a later time, the symptoms recorded by the patient during the perceived event can be compared with the patient's actual heart rhythm recorded by the device 100, which may help determine whether the patient-perceived event is related to an actual cardiac event. However, one problem with patient event triggers in currently available wearable heart rhythm monitoring devices is that small triggers can be difficult to detect and / or activate, especially since the monitoring device is typically worn inside clothing. Furthermore, pressing the trigger button may affect the electronics and / or electrodes on the device, causing the heart rhythm signal recorded at that moment to be altered solely by the device's movement caused by the patient's trigger. For example, even if no arrhythmic event actually occurs, pressing the trigger may vibrate one or two electrodes, making the heart rhythm signal recorded at that moment appear as if an arrhythmia has occurred. Additionally, the trigger may be unintentionally activated, for example, while the person is asleep or lying on the monitoring device.

[0103] However, in Figure 1A and Figure 1B In the illustrated embodiment, the rigidity of the housing 115 is sufficient, while the flexibility of the flexible body 110 is sufficient, such that movement applied by the patient to the housing 115 may rarely or never cause the electrodes to detect an abnormal signal. In this embodiment, the central portion of the upper housing member 140 is slightly recessed, and when a patient wearing the device 100 presses it, this central portion is slightly depressed to trigger the trigger input on the PCBA 120. Because the entire upper surface of the housing 115 acts as a patient event trigger, combined with its slight recess, the patient can usually easily find and press the trigger even if it is under clothing. Furthermore, the concave nature of the button allows it to be recessed, thus preventing accidental activation. Therefore, this embodiment can alleviate some of the problems encountered with patient event triggers on currently available heart rate monitors. This will be described in more detail below. Figure 1A and Figure 1B These and other aspects of the features shown.

[0104] Now refer to Figure 2A and Figure 2BIn embodiments, the printed circuit board assembly 120 (or PCBA) may include a top surface 220, a bottom surface 230, a patient trigger input 210, and spring contacts 235, 236, and 237. The printed circuit board assembly 120 may be used to mechanically support and electrically connect electronic components using conductive paths, traces, or electrode traces 311, 312. Furthermore, due to the sensitive nature of the PCBA 120 and the requirement for mechanical connection to the rigid body 115, it is beneficial that the rigidity of the PCBA 120 is sufficient to prevent undesirable deviations that may introduce noise or artifacts into the ECG signal. Force is particularly likely to be transmitted to the PCBA 120 through the rigid body 115 during patient trigger activation. In some embodiments, one way to ensure PCBA rigidity is to ensure that the thickness of the PCBA is relatively higher than a certain value. For example, a thickness of at least about 0.08 cm is desirable, and more preferably, a thickness of at least about 0.17 cm is desirable. In this application, PCBA 120 may also be referred to as a printed circuit board (PCB), printed circuit board (PWB), etched circuit board, or printed circuit assembly (PCA), or alternatively thereof. In some embodiments, in addition to PCBA 120, wire-wound or point-to-point constructions may be used, or wire-wound or point-to-point constructions may be used instead of PCBA 120. PCBA 120 may include analog circuitry and digital circuitry.

[0105] The patient trigger input 210 can be configured to relay a signal from a patient trigger, such as the aforementioned upper housing member 140, to the PCBA 120. For example, the patient trigger input 210 can be a PCB switch or button that responds to pressure from the patient trigger (e.g., the upper surface of the upper housing portion 140). In various embodiments, the patient trigger input 210 can be a surface-mount switch, a tactile switch, an LED-illuminated tactile switch, etc. In some embodiments, the patient trigger input 210 can also activate an indicator, such as an LED. Some embodiments may involve a remote trigger, such as on a separate device or as a smartphone application.

[0106] When collecting cardiac rhythm signals from human or animal subjects using a small, dual-electrode physiological monitoring device such as the device 100 described herein, a significant challenge is that having only two electrodes can sometimes provide a limited perspective when attempting to distinguish between artifacts and clinically significant signals. For example, when a left-handed patient brushes their teeth while wearing the small, dual-electrode physiological monitoring device on their left chest, brushing can often introduce motion artifacts, causing the recorded signal to appear very similar to ventricular tachycardia, a serious arrhythmia. Adding additional leads (and thus vectors) is a conventional approach to mitigate this concern, but this is typically done by adding additional wires adhered to different locations on the patient's chest, such as via a Holter monitor. This approach is not suitable for small, wearable, long-term monitors such as the physiological monitoring device 100.

[0107] Another approach to addressing the aforementioned problem is to provide one or more additional data channels to aid in signal identification. In some embodiments, for example, device 100 may include data channels for detecting patch motion. In some embodiments, an accelerometer or other suitable device can provide patch motion by simply analyzing amplitude variations of a single axis measurement or a combination of all three axes. The accelerometer can record device motion at a sufficient sampling rate to allow algorithmic comparison of its spectrum with the spectrum of a recorded ECG signal. If the motion and the recorded signal match, it is clear that the device recording for that time period is not from a clinical (e.g., cardiac) source, and therefore this portion of the signal can be confidently labeled as an artifact. This technique may be particularly useful in the brushing motion example described above, where the rapid motion frequency and high-amplitude artifacts resemble the heart rate and morphology of potentially life-threatening arrhythmias such as ventricular tachycardia, respectively. Other suitable devices described in this section and elsewhere in the specification may also be used to provide motion information.

[0108] In some embodiments, using values ​​from three axes for such analysis eliminates any abrupt changes in values ​​due to positional shifts rather than changes in activity. In other embodiments, using specific measurement axes, such as along the body's longitudinal axis, to focus on specific types of artifacts introduced by upward and downward movements associated with walking or running may have some advantages. Similarly, using a gyroscope in conjunction with an accelerometer can further determine the nature of the experienced motion. While accelerometers alone can adequately analyze whole-body motion, specific movements of interest, such as rotational motion due to arm movements, are highly complex and may not be discernible using accelerometers alone.

[0109] In addition to detecting motion artifacts, accelerometers tuned to the dynamic range of human body activity can provide information about a patient's activity level during recording, which can improve the accuracy of algorithms in detecting true arrhythmias. Given the single-lead limitation of device 100, observing arrhythmias that involve less pronounced waves (e.g., P waves) in addition to rate changes such as supraventricular tachycardia presents a challenge for both computerized algorithms and trained human eyes. This particular arrhythmia also has the characteristic of sudden onset; if a sudden surge in the patient's activity level is detected alongside an increase in heart rate, it can be more confidently distinguished from non-pathological sinus tachycardia. More broadly, providing activity information to clinical professionals can help them differentiate between exercise-related and non-exercise-related arrhythmias. Similar to motion artifact detection, single-axis accelerometer measurements optimized for a specific direction can help to more specifically determine the type of activity, such as walking or running. This additional information can help to interpret symptoms more specifically, thus influencing subsequent treatment.

[0110] In some embodiments, an accelerometer with three axes can provide advantages beyond those offered by the amplitude of motion. When the subject is not moving rapidly, the 3D accelerometer readings may approximate the tilt of the PCBA120, thus indicating the body's orientation relative to its original orientation. The original body orientation can be assumed to be upright or supine, which is necessary for proper positioning and application of the device to the body. This information may help rule out certain cardiac conditions that manifest as beat-by-beat morphological changes, such as alternation of heart movements with observed periodic amplitude variations, commonly seen in cases of heart failure. Similar beat-by-beat morphological changes can be observed in healthy subjects when body position changes, due to changes in the heart's position relative to the electrode carrier, such as from upright to relaxed. By design, the single-channel device 100 lacks a backup ECG channel to easily rule out potential morphological pathological changes; however, the correlation with changes in body orientation will help interpret these normal changes and avoid unnecessary treatment due to misdiagnosis.

[0111] In other embodiments, the accelerometer can also be used as a sleep indicator based on body orientation and movement. When presenting clinical events (e.g., pauses), it is helpful for diagnosis to be able to present information in a way that clearly distinguishes events occurring during sleep from those occurring during wakefulness. Indeed, some algorithms, such as those used for ECG-derived respiratory rates, only make sense when the patient is relatively still, allowing subtle signal modulation introduced by chest movements due to breathing to be observed. Respiratory rate information is useful as an information channel needed to detect sleep apnea in certain patient populations.

[0112] In some embodiments, the accelerometer can also be used to detect free fall, such as syncope. With the accelerometer, device 100 can flag syncope and other free fall events without relying on a patient trigger. In some embodiments, such a free fall event trigger can initiate the transmission of associated data. To enable timely detection of such critical events, but considering the battery and memory limitations of small wearable devices like device 100, accelerometer readings can be acquired instantaneously, with only information of interest, such as potential free fall, written to memory at a high sampling rate. This event trigger concept is extended to use specific tapping actions on device 100 as patient triggers instead of the previously described buttons, or to combine specific tapping actions on device 100 with the previously described buttons. Using and detecting multiple types of tapping sequences allows for a more accurate understanding of the patient's exact feelings and then provides a better solution, rather than relying on the patient manually recording their symptoms and duration in a trigger log afterwards. An example of this enhanced solution is indicating the severity of symptoms by the number of consecutive taps.

[0113] Optionally, in other embodiments, an optical sensor may be used to distinguish between device movement and patient body movement. Further, in other embodiments, the device may not require a button or trigger. In many more embodiments, suitable devices described in this section or elsewhere in the specification may also be used.

[0114] Another optional data channel that can be added to the physiological monitoring device 100 is a channel for detecting the flexibility and / or curvature of the device 100. In various embodiments, for example, the device 100 may include strain gauges, piezoelectric sensors, or optical sensors for detecting motion artifacts on the device 100 itself, thereby helping to distinguish motion artifacts from heart rate data. Yet another optional data channel of the device 100 may be a channel for detecting heart rate. For example, a pulse oximeter, microphone, or stethoscope can provide heart rate information. Redundant heart rate data may help distinguish ECG signals from artifacts. This is particularly useful in cases where arrhythmias such as supraventricular tachycardia are interrupted by artifacts, and it must be determined whether the episode is actually multiple shorter episodes or a continuous episode. Another data channel may be included to detect ambient electrical noise. For example, the device 100 may include an antenna for receiving electromagnetic interference. Detection of electromagnetic interference can facilitate the distinction between electrical noise and genuine ECG signals. Any of the above data channels may be stored to support future noise discrimination or for immediate, real-time determination of clinical effectiveness.

[0115] Now refer to Figure 3A and Figure 3B The embodiment is shown in more detail, with the flexible body 110 illustrated. For example... Figure 3AAs shown, the flexible body 110 may include wings 130, 131, a thin boundary 133 (or “edge” or “side”) surrounding at least a portion of each wing 130, 131, electrode traces 311, 312, and a hinge 132 (or “shoulder”) at or near the junction of each wing 130, 131 with the housing 115. Figure 3A The upper gasket 370 is also shown, which is not considered part of the flexible body 110 in this description, but it helps to attach the flexible body 110 to the housing 115.

[0116] The hinges 132 are relatively thinner, or even more flexible, portions of the flexible body 110. They allow the flexible body 110 to bend freely in the area where it connects to the housing 115. This flexibility improves comfort because the housing 115 can be freely lifted away from the patient's skin during patient movement. The electrode traces 311, 312 are also very fine and flexible to allow the patient to move without causing signal distortion. The boundary 133 is a portion of the flexible body 110 that is thinner than the directly adjacent portion and provides a smooth transition from the flexible body 110 to the patient's skin, thereby preventing edge lifting and the penetration of dirt or debris beneath the flexible body 110.

[0117] like Figure 3BAs shown in more detail below, the flexible body 110 may include multiple layers. As previously mentioned, in some embodiments, the upper gasket 370 and lower gasket 360 are not considered part of the flexible body 110 for illustrative purposes, but are shown for the completeness of the description. However, this distinction is merely for ease of description and should not be construed as limiting the scope of the described embodiments. The flexible body 110 may include a top substrate layer 300, a bottom substrate layer 330, an adhesive layer 340, and a flexible electrode 350. The top substrate layer 300 and the bottom substrate layer 330 may be made of any suitable flexible material, such as one or more flexible polymers. Suitable flexible polymers may include, but are not limited to, polyurethane, polyethylene, polyester, polypropylene, nylon, polytetrafluoroethylene, and carbon-impregnated vinyl. The materials of the substrate layers 300 and 330 may be selected based on desired properties. For example, the materials of the substrate layers 300 and 330 may be selected based on flexibility, elasticity, durability, breathability, moisture evaporation, adhesion, etc. In one embodiment, for example, the top substrate layer 300 may be made of polyurethane, while the bottom substrate layer 330 may be made of polyethylene or polyester. In other embodiments, the base layers 300 and 330 may be made of the same material. In yet another embodiment, the base layer 330 may include multiple perforations in the area above the adhesive layer 340 to provide better breathability and moisture evaporation. In various embodiments, a patient may wear the physiological monitoring device 100 continuously for up to 14 to 21 days or longer without removal during wear and while showering, exercising, etc. Therefore, the materials used, as well as the thickness and construction of the base layers 300 and 330, affect the functionality of the physiological monitoring device 100. In some embodiments, the material of the base layers 300 and 330 acts as an electrostatic discharge (ESD) barrier to prevent arcing.

[0118] Typically, the top substrate layer 300 and the bottom substrate layer 330 are attached to each other via an adhesive placed on one or both layers 300, 330. For example, the adhesive or bonding material between the substrate layers 300, 330 may be an acrylic-based, rubber-based, or silicone-based adhesive. In other alternative embodiments, the flexible body 110 may include more than two layers of flexible material.

[0119] In addition to the choice of materials, the dimensions of the substrate layers 300 and 330, such as thickness, length, and width, can be selected based on the desired characteristics of the flexible body 110. For example, in various embodiments, the thickness of the substrate layers 300 and 330 can be selected to give the flexible body 110 a total thickness of about 0.1 mm to about 1.0 mm. According to various embodiments, the flexible body 110 may also have a length of about 7 cm to 15 cm and a width between about 3 cm and about 6 cm. Typically, the flexible body 110 will have a length sufficient to provide the necessary amount of spacing between the electrodes 350. For example, in one embodiment, the distance from the center of one electrode 350 to the center of another electrode 350 should be at least about 6.0 cm, more preferably at least about 8.5 cm. This spacing distance may vary depending on the application. In some embodiments, the substrate layers 300 and 330 may both have the same thickness. Alternatively, the two substrate layers 300 and 330 may have different thicknesses.

[0120] As described above, the hinge 132 allows the rigid body 115 to be lifted away from the patient while the flexible body 110 remains adhered to the skin. The function of the hinge 132 is crucial for allowing the device to remain adhered to the patient during various activities that may stretch and compress the skin. Furthermore, the hinge 132 allows for a significant improvement in comfort when wearing the device. Typically, the hinge 132 is wide enough to allow the rigid body 115 to be lifted sufficiently without exerting excessive peeling force on the flexible body 110. For example, in various embodiments, the width of the hinge 132 should be at least about 0.25 cm and more preferably at least about 0.75 cm.

[0121] Furthermore, the shape or coverage area of ​​the flexible body 110 can be selected based on the desired characteristics. For example... Figure 3A As shown, wings 130, 131 and boundary 133 can be circular edges that give the flexible body 110 an overall "peanut" shape. However, wings 130, 131 can be formed into any number of different shapes, such as rectangular, elliptical, ring-shaped, or strip-shaped. Figure 3A and Figure 3BIn the illustrated embodiment, the coverage area of ​​the top base layer 300 is larger than that of the bottom base layer 330, wherein the top base layer 300 extends to form a boundary 133. Therefore, the boundary 133 is made of the same polyurethane material as the top layer 300. Because they comprise only the top layer 300, the boundary 133 is thinner than the adjacent portions of each wing 130, 131. The thinner, highly malleable edge and / or boundary 133 may enhance the adhesion of the physiological monitoring device 100 to the patient, as it provides a transition from the adjacent, slightly thicker portions of the wings 130, 131 to the patient's skin, thus helping to prevent the edges of the device 100 from peeling off the skin. The boundary 133 also helps prevent dirt and other debris from accumulating beneath the flexible body 110, which can help promote adhesion to the skin and also enhance the aesthetics of the device 100. In an alternative embodiment, the coverage areas of the base layers 300, 330 may be identical, thus eliminating the need for a boundary 133.

[0122] Although Figures 1A to 3B The illustrated embodiment includes only two wings 130, 131 extending from the housing 115 in generally opposite directions (e.g., at 180-degree angles to each other), but other configurations are possible in alternative embodiments. For example, in some embodiments, the wings 130, 131 may be arranged in asymmetrical directions and / or one or more additional wings may be included. Any suitable configuration and any number of wings 130, 131 and electrode traces 311, 312 can be used, provided that sufficient electrode spacing is provided to allow physiological signal monitoring and that the wings 130, 131 are configured to provide extended adhesion to the skin. The above embodiments have proven advantageous for adhesion, patient comfort, and the accuracy of the collected cardiac rhythm data, but alternative configurations may be implemented in alternative embodiments.

[0123] The adhesive layer 340 is an adhesive applied to two portions of the bottom surface of the bottom base layer 330, each portion corresponding to one of the wings 130, 131. The adhesive layer 340 therefore does not extend along the portion of the bottom base layer 330 where the housing 115 is mounted. The adhesive layer 340 can be made of any suitable adhesive, although certain adhesives have been found to provide relatively comfortable and long-term adhesion to the patient's skin without skin irritation. For example, in one embodiment, the adhesive layer 340 is a hydrocolloid adhesive. In another embodiment, the adhesive layer 340 is composed of a hydrocolloid adhesive containing naturally derived or synthetic absorbent materials that absorb moisture from the skin during perspiration.

[0124] Now refer to Figure 3BEach of the two portions of the adhesive layer 340 includes a hole into which one of the electrodes 350 is fitted. The electrodes 350 are made of a flexible material to further provide overall conformability to the flexible body 110. In one embodiment, for example, the flexible electrode 350 may be made of a hydrogel electrode 350. The electrodes 350 typically provide conformal, non-irritating contact with the skin to provide enhanced electrical connectivity with the skin and reduce motion artifacts. In some embodiments, the hydrogel electrodes 350 may be stamped into the adhesive layer 340, thereby forming holes and filling them with the hydrogel electrodes 350. In an alternative embodiment, the electrodes 350 and adhesive 340 may be replaced with an adhesive layer made of a conductive material, such that the entire adhesive layer on the underside of each wing 130, 131 serves as an electrode. Such an adhesive layer may comprise a mixture of adhesive / conductive substances or an adhesive substance mixed with conductive elements or particles. For example, in one embodiment, such an adhesive layer may be a mixture of hydrogel and hydrocolloid adhesive. Figure 1A The housing 115 also protects the electronics and power supply contained within it, enhances the patient's ability to provide input related to sensed cardiac events, and allows for the simple manufacture and reuse of at least some of the contents of the housing 115. These and other features of the physiological monitoring device 100 are described in more detail below.

[0125] As described above, in some embodiments, the adhesive layer 340 may cover a portion of the lower side of the underlying substrate 330, such that at least a portion of the bottom side of the flexible body 110 does not include the adhesive layer 340. Figure 3A As shown, hinge 132 may be formed in the flexible body 110 as a portion of the unadhesive layer 340 applied to each wing 130, 131. Hinge 132 is typically located at or near the junction of the flexible body 110 and the housing 115, thereby providing the device 100 with flexibility to accommodate patient movement. In some embodiments, the width of hinge 132 may be less than the width of adjacent portions of the wings 130, 131, thus giving the device 100 the aforementioned “peanut” shape. As shown in FIG8, the device 100 bends as the subject moves. Device bending can be severe and may occur many times during long-term monitoring. Hinge 132 allows for dynamic fit with the subject, while the rigidity of the housing 115 allows the housing 115 to pop off the patient's skin during device bending, thereby preventing the device 100 from peeling off the skin at its edges.

[0126] The flexible body 110 further includes two electrode traces 311 and 312 sandwiched between the upper base layer 300 and the lower base layer 330. Each electrode trace 311 and 312 may include an electrode interface portion 310 and an electrocardiogram circuit interface portion 313. Figure 3C and Figure 3DAs shown in the embodiments, the ECG circuit interface 313 is in physical contact with the spring contact 237 and provides electrical communication with the PCBA 120 when the device 100 or the amplification device 101 is assembled. The electrode interface 310 contacts the hydrogel electrode 350. Therefore, the electrode traces 311, 312 transmit heart rhythm signals (and / or other physiological data in various embodiments) from the electrode 350 to the PCBA 120.

[0127] The material and thickness of electrode traces 311, 312 are important for providing the desired combination of flexibility, durability, and signal transmission. For example, in one embodiment, electrode traces 311, 312 may include a combination of silver (Ag) and silver chloride (AgCl). The silver and silver chloride may be layered. For example, one embodiment of electrode traces 311, 312 may include a top silver layer, an intermediate carbon-impregnated vinyl layer, and a bottom (patient-facing) silver chloride layer. In another embodiment, both the top and bottom layers of electrode traces 311, 312 may be made of silver chloride. In one embodiment, the top and bottom layers may be applied to the intermediate layer in the form of silver ink and silver chloride ink, respectively. In alternative embodiments, each electrode trace may include only two layers, such as a top silver layer and a bottom silver chloride layer. In various embodiments, the bottom material of each electrode trace 311, 312, such as AgCl, may be selected to match the chemistry of the hydrogel electrode 350 and form a half-cell with the subject's body.

[0128] The thickness of the electrode traces 311, 312 can be selected to optimize any one of several desired properties. For example, in some embodiments, at least one of the layers of electrode traces 311, 312 may have sufficient thickness to minimize or mitigate material loss over time due to anodic / cathode effects. Furthermore, the thickness can be selected for desired flexibility, durability, and / or signal transmission quality.

[0129] As described above, in some embodiments, the top gasket 370 and the bottom gasket 360 may be attached to the upper substrate 300 and the lower substrate 330 of the flexible body 110. Gaskets 360 and 370 may be made of any suitable material such as polyurethane, which provides a waterproof seal between the upper housing member 140 and the lower housing member 145 of the housing 115. In one embodiment, the top gasket 370 and / or the bottom gasket 360 may include an adhesive surface. Figure 3E Another embodiment is depicted, in which the top gasket 370 includes a lug 371 that protrudes from the outline of the top housing 140 while still adhering to the upper substrate 300. The lug 371 covers a portion of the electrode traces 311, 312 and provides strain relief for the traces at the point of highest stress where the flexible body meets the housing.

[0130] Now refer to Figure 4 The embodiment illustrates, in more detail, the upper housing member 140 and the lower housing member 145 of the housing 115. The upper housing member 140 and the lower housing member 145 may be configured to form waterproof attachments for housing the PCBA 120, battery holder 150, battery 160, and any other components housed within the housing 115 when joined together with gaskets 360, 370 between them. The housing members 140, 145 may be made of any suitable material, such as waterproof plastic, to protect the internal components. In one embodiment, the upper housing member 140 may include rigid sidewalls and / or hooks 440, a light tube 410 for transmitting visual information from LEDs on the PCBA through the housing member, a slightly flexible top surface 420, and an internal trigger member 430 extending inwardly from the top surface 420. The top surface 420 is configured to be pressed by a patient when he or she perceives an arrhythmia or other cardiac event. When pressed, the top surface 420 presses into and activates the internal trigger member 430 of the trigger input 210 of the PCBA 120. Furthermore, as previously mentioned, the top surface 420 can be concave (a concave surface facing the interior of the housing 115) to accommodate the shape of a finger. It is believed that the design of the upper housing member 140 isolates the activation of the trigger input 210 from the electrode 350, thereby minimizing artifacts in data recording.

[0131] Continue to refer to Figure 4 The lower housing member 145 may be configured to be detachably connected to the upper housing member 140 in such a way that housing members 140 and 145 can be easily attached and detached to reuse at least some components of the monitoring device 100. In some embodiments, the bottom surface 445 (the patient-facing surface) of the lower housing member 145 may include a plurality of recesses 450 (or “bumps”, “ears”, etc.) that will contact the patient’s skin during use. The recesses 450 may allow airflow between the bottom surface 445 and the patient’s skin, thereby preventing the formation of a seal between the bottom surface 445 and the skin. It is believed that the recesses 450 improve comfort and help prevent the following perception of currently available devices, namely, that the patient feels the monitoring device 100 appears to be detaching when the housing 115 is lifted away from the skin and breaks the seal with the skin. In yet another embodiment, the bottom surface 445 of the lower housing member 145 may include a plurality of recesses (recesses rather than ear-like protrusions) for preventing the formation of a seal.

[0132] Now refer to Figure 5A The embodiment shown in more detail illustrates the battery holder 150. The battery holder 150 may be made of plastic or other suitable material, is configured to mount to the PCBA 120 and subsequently attach to the housing 115, and is capable of accommodating two batteries 160. Figure 1BIn an alternative embodiment, the battery holder 150 may be configured to accommodate one or more batteries. Multiple lugs 152 provide a stable platform for the battery 160 at a fixed distance above the surface of the PCBA 120, thereby avoiding undesirable contact with sensitive electronic components, while providing sufficient compression of the spring contacts 235. Figure 5B Lug 153 locks battery 160 in place and resists the upward force of spring contact 235 on the battery. Battery holder 150 also properly positions battery 160 to provide sufficient compression of spring contact 236. Using battery holder 150 in conjunction with spring contacts 235 and 236 allows battery 160 to be electrically connected to PCBA 120 while still having additional electronics between battery 160 and PCBA 120 and keeping the assembly compact. Battery holder 150 may include flexible hook 510 that engages with a corresponding rigid hook 440 of upper housing member 140. Under normal assembly conditions, flexible hook 510 remains firmly engaged with rigid hook 440. For disassembly, flexible hook 510 can be pushed and bent using a suitable tool through top housing 140, thereby disengaging it from rigid hook 440, and subsequently allowing removal of top housing 140.

[0133] Now refer to Figure 6A and Figure 6B An embodiment is shown in a side cross-sectional view of the physiological monitoring device 100. For example... Figure 6A As shown, the physiological monitoring device 100 may include a flexible body 110 coupled to a housing 115. The flexible body 110 may include a top base layer 300, a bottom base layer 330, an adhesive layer 340, and electrodes 350. Electrode traces 311, 312 are generally also part of the flexible body 110 and are embedded between the top base layer 300 and the bottom base layer 330, but they are not shown in FIG. 6. The flexible body 110 forms two wings 130, 131 extending to both sides of the housing 115, and a boundary 133 surrounding at least a portion of each wing 130, 131. The housing 115 may include an upper housing member 140 coupled to a lower housing member 145 such that the housing 115 clamps a portion of the flexible body 110 in the middle and provides a waterproof, sealed compartment for the PCBA 120. The upper housing member 140 may include an internal trigger member 430, and the PCBA may include a patient trigger member 210. As previously described, the lower housing component 145 may include a plurality of recesses 450 or recesses to enhance the comfort of the monitoring device 100.

[0134] It is desirable for the PCBA 120 to have sufficient rigidity to prevent bending and the introduction of unwanted artifacts into the signal. In some embodiments, additional mechanisms can be used to reduce and prevent undesirable bending of the PCBA 120. Such mechanisms include... Figure 6BAs shown. The support rod 460 is integral with the lower housing 145 and is located directly below the patient trigger input 210. During patient symptom triggering, the upper housing member 140 is depressed, engaging with the internal trigger mechanism 430 and transmitting force to the PCBA 120 via the patient trigger input 210. The force is further transmitted through the PCBA 120 and into the support rod 460 without generating a bending moment, thus avoiding unwanted artifacts.

[0135] Reference Figure 7 In some embodiments, the physiological monitoring device 100 may include one or more additional optional features. For example, in one embodiment, the monitoring device 100 may include a removable liner 810, a top label 820, a device identifier 830, and a bottom label 840. The liner 810 may be applied to the top surface of the flexible member and / or the body 110 to aid in application of the device 100 to a subject. As described in further detail below, the liner 810 may help support the boundaries 133 and wings 130, 131 of the flexible body 110 during the removal of one or more adhesive covers (not shown) covering the adhesive surface 340 prior to use. The liner 810 may be relatively rigid and / or robust to help support the flexible body 110 during the removal of the adhesive covers. In various embodiments, for example, the liner 810 may be made of cardboard, thick paper, plastic, etc. The liner 810 typically includes an adhesive on one side to adhere to the top surface of the wings 130, 131 of the flexible body 110.

[0136] Labels 820 and 840 can be any suitable label and may include product name, manufacturer name, logo, graphic, etc. They may be removable or permanently attached to the upper housing member 140 and / or the lower housing member 145 to prevent unauthorized reuse and / or resale of the device by unregistered users, although they are typically permanently attached. Device identifier 830 may be a barcode label, computer-readable chip, RFID, etc. Device identifier 830 may be permanently or removably attached to PCBA 120, flexible body 110, etc. In some embodiments, it may be advantageous to have device identifier 830 attached to PCBA 120.

[0137] Now for reference Figure 8A and Figure 8BIn some embodiments, the physiological monitoring device 100 typically includes a hinge 132 located at or near the junction of each wing 130, 131 with the housing 115. Furthermore, each wing 130, 131 is typically adhered to the patient via an adhesive layer 340, while the rigid body 115 is not adhered to the patient and thus freely “floats” (e.g., moves up and down) on the patient's skin during patient movement and changes in posture. In other words, when the patient's chest contracts, the housing pops out or floats on the skin, thereby minimizing pressure on the device 100, increasing comfort, and reducing the tendency for the wings 130, 131 to detach from the skin. Figure 8A and Figure 8B The diagram illustrates the advantages offered by the combination of the buoyancy rigid body 115 and the adhesion wings 130, 131. Figure 8A In the middle, the patient is sleeping, while... Figure 8B In the image, the patient is playing golf. In both examples, the monitoring device 100 is pressed together by the patient's body, causing the housing 115 to float above the skin as the wings 130, 131 move closer together. The advantages of the floating, non-attached portion of the physiological monitoring device are described in more detail in U.S. Patent 8,560,046, which has been previously incorporated by reference.

[0138] Now refer to Figures 9A to 9F This describes an embodiment of a method for applying a physiological monitoring device 100 to the skin of a human subject. In this embodiment, in Figure 9A Prior to the first step shown, the patient's skin is typically prepared by trimming a small section of skin on the left chest where the device 100 will be placed, followed by sanding and / or cleaning the trimmed area. (As shown) Figure 9A As shown, once the patient's skin is prepared, the first step of applying the device 100 may include removing one or both of the two adhesive covers 600 from the adhesive layer 340 on the bottom surface of the device 100, thereby exposing the adhesive layer 340. Figure 9B As shown, the next step may be to apply the device 100 to the skin, causing the adhesive layer 340 to adhere to the skin at the desired location. In some embodiments, one adhesive cover 600 may be removed, the uncovered adhesive layer 340 may be applied to the skin, then a second adhesive cover 600 may be removed, and a second adhesive layer 340 may be applied to the skin. Optionally, both adhesive covers 600 may be removed before the device 100 is applied to the skin. While the adhesive covers 600 are being removed, the liner 810 acts as a support for the flexible body 110, providing something for the doctor or other user to grip, and preventing the flexible body 110 and its boundary 133 from folding up on their own, forming wrinkles, etc. As described above, the liner 810 may be made of a relatively rigid, strong material to provide support for the flexible body 110 during the application of the device 100 to the skin. (See reference...) Figure 9CAfter the device 100 has been applied to the skin, pressure can be applied to the flexible body 110 to press it down onto the chest to help ensure that the device 100 adheres to the skin.

[0139] In the next step, refer to Figure 9D The liner 810 is removed (e.g., peeled off) from the top surface of the flexible body 110. Figure 9E As shown, once the liner 810 is removed, pressure can be applied again to the flexible body 110 to help ensure it adheres to the skin. Finally, as Figure 9F As shown, the physiological monitoring device 100 can be activated by pressing the upper housing component 140. The described method is only one embodiment. In alternative embodiments, one or more steps may be skipped and / or one or more additional steps may be added.

[0140] In some embodiments, when the desired monitoring period has ended, such as approximately 14 to 21 days in some cases, the patient (or physician, nurse, etc.) can remove the physiological monitoring device 100 from the patient's skin, place the device 100 in a prepaid mailbag, and mail the device 100 to a data processing facility. At this facility, the device 100 can be partially or completely disassembled, the PCBA 120 can be removed, and stored physiological data, such as continuous heart rhythm information, can be downloaded from the device 100. The data can then be analyzed by any suitable method and provided to the physician in the form of a report. The physician can then discuss the report with the patient. The PCBA 120 and / or other parts of the device 100, such as the housing 115, can be reused in subsequent manufacturing of devices for the same patient or other patients. Because the device 100 is constructed as a combination of several removably connected components, various components can be reused in the same or different embodiments of the device 100. For example, the PCBA 120 can be first used in an adult heart rhythm monitor and then again used to construct a sleep apnea monitor. The same PCBA 120 can be used additionally or optionally with a flexible body 110 of a different size to construct a pediatric cardiac monitor. Therefore, at least some components of the device 100 can be interchangeable and reusable.

[0141] In a further embodiment described in more detail below, monitoring data can be transmitted wirelessly or via other communication media for analysis without the need for physical shipping equipment for analysis and reporting.

[0142] Advantageously, the physiological monitoring device 100 can provide long-term adhesion to the skin. The combination of the construction of the flexible conformal body 110, the waterproof and thin construction of the housing 115, and the interface between the two allows the device 100 to compensate for stress caused by the stretching and bending of the subject's skin. Therefore, the device 100 can be worn continuously on a patient for up to 14 to 21 days or longer without removal. In some cases, the device 100 can be worn for longer or shorter periods, but 14 to 21 days is generally likely the ideal amount of time for collecting cardiac rhythm data and / or other physiological signal data from the patient.

[0143] One or more of the various components of the physiological monitoring device 100 may be alternately configured or replaced with embodiments of components disclosed elsewhere herein. For example, in some embodiments, the electrode 350 and / or the flexible body 110 may be configured to deliver one or more therapeutic agents to a patient's skin, such as via a drug-eluting adhesive or other suitable delivery system. One or more therapeutic agents may be configured to counteract skin irritation, itching, and / or bacterial growth; may be configured to induce or block histamine release; and / or may include anesthetic properties, any of which may improve patient compliance and / or prolong the duration of wear of the physiological monitoring device 100. The therapeutic agents may also be used for alternative or additional therapeutic purposes. In some embodiments, the therapeutic agent may be directly incorporated into the adhesive layer 340. For example, the therapeutic agent may be mixed into a hydrocolloid solution during the manufacture of the adhesive layer 340. The therapeutic agent may be configured to elute from the adhesive layer 340 and come into contact with the patient's skin. The adhesive layer 340 may be configured to provide controlled drug release. For example, the adhesive layer 340 may be configured to release a drug gradually and / or at a substantially constant rate over a period of time (e.g., over approximately: 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, etc.). The adhesive layer 340 may include perforated and / or microporous structures configured to facilitate diffusion of one or more therapeutic agents through the thickness of the adhesive layer 340. In some embodiments, the therapeutic agent may be incorporated into one or more overlay support layers of the flexible body 110, such as a top base layer 300 and / or a bottom base layer 330. The support layers of the flexible body 110 may include pockets or containers configured to store one or more therapeutic agents. The pockets may be in fluid communication with the adhesive layer 340 through perforations formed in the base layer or through pores or channels formed in the base layer. In some embodiments, one or more therapeutic agents may diffuse through the adhesive layer 340 to reach the skin. In some embodiments, the perforations in the base layer may extend through the adhesive layer 340 to reach the surface of the patient's skin. In some embodiments, the electrode 350 or the flexible body 110 may be configured to include an antimicrobial agent to inhibit microbial growth. These agents may include coatings or embedded components of adhesives or electrode gel materials. These antimicrobial agents may be configured to release the drug gradually and / or at a substantially constant rate over a period of time (e.g., over approximately: 1 day, 3 days, 5 days, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 1 month, 3 months, 5 months, 1 year, 3 years, 5 years, etc.). The adhesive layer 340 may include perforated and / or microporous structures configured to facilitate the diffusion of one or more therapeutic agents through the thickness of the adhesive layer 340. Optionally, the antimicrobial properties may be an inherent characteristic of the structure of the adhesive, gel, or any substrate or support layer. In other embodiments, the electrode 350 or flexible body 110 may be configured to release deodorant or fragrance components to reduce odors that may develop due to prolonged wear.Similar to the therapeutic and antibacterial agents mentioned above, these ingredients can be configured to release over time and / or diffuse through the thickness of the adhesive or gel layer.

[0144] Figures 10A to 10C An alternative example of trace layer 609 is schematically shown. Trace layer 609 may include each electrode 350 of physiological monitoring device 100 (e.g., Figure 3B The traces 611 and 612 (shown) may be disposed (e.g., printed onto) a non-conductive insulating layer 613. In some embodiments, the insulating layer 613 may comprise a polyester, such as polyethylene terephthalate (PET), and / or another non-conductive polymer. One or more of the traces 611 and 612 may be disposed on the same insulating layer 613. The insulating layer 613 may be configured to keep traces 611 and 612 connected to different electrodes 350 separated. The traces 611 and 612 may extend from the electrodes 350 into the housing 115 to make electrical contact with the PCBA 120. In some embodiments, such as a physiological monitoring device 100, which includes two opposing wings 130 and 131 arranged substantially collinearly to each other, the traces 611 and 612 may extend substantially collinearly along a direction defining the longitudinal axis of the device. The transverse axis may be defined as substantially perpendicular to the longitudinal axis. The vertical axis and / or horizontal axis can substantially bisect the housing 115 of the physiological monitoring device 100.

[0145] Each trace 611, 612 can extend along the connection portion of the trace layer 609 from the electrode contact area configured to contact the electrode 350 to the housing area configured to be accommodated within the housing 115 (e.g., between the upper housing 140 and the lower housing 145, such as...). Figure 7 Above and Figure 12 to Figure 13B (As shown below). The shell region of trace layer 609 may have a shell-meeting region that is generally configured to match the outer edges of the upper shell 140 and the lower shell 145 (or as described below). Figures 12A to 15IThe embodiments described herein, such as 640 and 645, are relevant. For example, trace layer 609 may include a generally circular housing region. Trace layer 609 may have a plurality of holes 616 extending between an upper surface and a lower surface of trace layer 609. Holes 616 may allow mechanical elements (e.g., rods as described elsewhere herein) to pass through, such as mechanical elements that engage or mate the upper housing 140 and the lower housing 145. Holes 616 may be disposed generally along the outer edge of the housing region of trace layer 609. Holes 616 may extend only through insulating layer 613 and not through electrical traces 611, 612. At least some of the holes 616 may be sized to substantially match the size of one or more mechanically mating elements (e.g., rods), such that one or more mechanically mating elements passing through holes 616 may help stabilize the orientation of trace layer 609 and / or help secure trace layer 609 to housing 115. The housing region of trace layer 609 may include a large central aperture through which components in the upper housing 140 can directly contact components in the lower housing 145 (or as described below). Figures 12A to 15I As described in the embodiments, such as 640 and 645). The housing regions of electrical traces 611, 612 may be disposed on opposite sides of the insulating layer 613 within the housing region of trace layer 609. Trace layer 609 may extend substantially along the longitudinal axis between the electrode contact regions. The connection between the electrode contact regions and the housing regions of trace layer 609 may include a transverse width smaller than the width of the electrode contact regions and / or housing regions of trace layer 609.

[0146] Electrical traces 611, 612 may be disposed (e.g., printed and / or applied in any suitable manner) on one or both sides (top and bottom) of insulating layer 613. Electrical traces 611, 612 may include any conductive material discussed elsewhere herein. For example, in some embodiments, electrical traces 611, 612 may include a silver (Ag) layer printed on insulating layer 613. In embodiments, in addition to the silver or other conductive material layer typically used for traces 611, 612, the electrode interface portion 310 of electrical traces 611, 612 may include a silver chloride (AgCl) layer, as described elsewhere herein. In some embodiments, a silver chloride layer or other electrode interface material may be printed on top of the silver layer or other conductive layer of electrical traces 611, 612. Silver may provide a more isotropic conductivity than silver chloride, which may provide better lateral conductivity along the x and y directions but worse vertical conductivity along the z direction (transverse to the longitudinal and transverse axes). In some embodiments, the electrical traces 611, 612 may be primarily disposed on one side of the insulating layer 613 (e.g., the bottom side or the patient-facing side). For example, the portion of the traces 611, 612 connecting the electrode interface portion 310 and the trace layer 609 may be disposed on only one side, but the electrocardiogram circuit interface portion 313 of the traces 611, 612 may be located on the opposite side of the trace layer 609. Arranging the electrode interface portion 310 and the electrocardiogram circuit interface portion 313 on the opposite side of the trace layer 609 allows for easy connection of the electrical traces 611, 612 and the PCBA 120, which may be located on the opposite side of the trace layer 609 away from the patient's skin to minimize the amount of space occupied by the housing 115 between the patient and the trace layer 609. In some embodiments, the trace layer 609 may include one or more through holes 619 formed in through-holes extending through the insulating layer 613 of the trace layer 609. Through-holes can be formed by passing through conductive material traces 611, 612 and filling them with the same and / or different conductive materials to form vias 619 that conduct electrical signals from one side of trace layer 609 to the other. Through-holes 619 simplify the design and construction of trace layer 609 by avoiding the use of bends in the metal assembly. In some embodiments, conductive rivets can be used in addition to conductive vias 619. The ECG circuit interface portion 313 of traces 611, 612 may include a relatively larger surface area than traces 611, 612 along the connection portion of trace layer 609 to provide sufficient contact area for electrical contact to electrically connect traces 611, 612 to PCBA 120.

[0147] like Figure 10BAs shown, in some embodiments, one or more resistors 614 may be disposed within traces 611, 612. Resistor 614 may include a conductive material with increased resistance than a conductive material (e.g., silver and / or silver chloride) typically used to conduct electricity between electrodes 350 and PCBA 120. For example, resistor 614 may include carbon and / or an increased amount of carbon compared to traces 611, 612. In some embodiments, the resistance value of the resistor is at least about: 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100 kiloohms (kΩ). The material of resistor 614 can be selected to reduce or minimize "popcorn" noise or 1 / f noise. Figures 10A to 10C As shown, resistor 614 may intersect the conductive paths of traces 611, 612 between electrode interface portion 310 and electrocardiogram interface portion 313, such that it is arranged in a straight line with the conductive material of the traces. Resistor 614 may be disposed on the housing portion of trace layer 609 such that they are enclosed within housing 115. Resistor 614 may be disposed (e.g., printed) on substrate layer 613 in the same or different manner as the conductive material of traces 611, 612. Resistor 614 may replace resistors disposed on PCBA 120, thereby potentially providing the advantage of space saving. In some embodiments, resistor 614 may be used to reduce the current flowing along the circuit formed by the body and interface electrodes 350. Resistor 614 may serve as a safety device allowing physiological monitoring device 100 to be adapted for use with a patient.

[0148] Return to Figure 10AIn some embodiments, the electrode interface portion 310 may include a central hole 617. The central hole 617 can typically be circular or any suitable shape, such as elliptical, square, triangular, rectangular, or suitable polygonal. The central hole 617 can provide improved moisture management. For example, moisture accumulated between the electrode 350 and the patient's skin can evaporate through the electrode (e.g., a hydrogel electrode) and through the central hole 617 and / or through a breathable base layer located on the central layer. Improved moisture management can suppress delamination and increase the wearing duration of the physiological monitoring device, thereby allowing for longer use. In some embodiments, the trace layer 609 may include a plurality of central holes 617 located on the upper surface of the electrode 350. The cumulative surface area of ​​one or more central holes and / or through-holes 619 can be balanced relative to the surface area of ​​the electrode 350 to prevent the hydrogel electrode 350 from drying out and / or reduce conductivity fluctuations that may occur when the electrode delaminates from the skin, since metals are more conductive than hydrogels. In some embodiments, the trace layer 609 may be without a substrate layer, or any covering substrate layer may include a corresponding hole located above the central hole 617, such that at least a portion of the upper surface of the electrode 350 is exposed to the surrounding environment. In some embodiments, the diameter of the central hole 617 may be slightly smaller than the outer diameter of the electrode 350, such that the trace layer 609 is located above the upper surface of the electrode 350. An electrical connection may be formed between the upper surface of the electrode and the lower surface of the trace layer 609 via the electrode interface portion 310 of the electrical traces 611, 612. In some embodiments, the diameter of the central hole 617 substantially matches the outer diameter of the electrode 350, such that the electrode 350 can be accommodated within the central hole 617. In addition to interactions between other portions and surfaces, an electrical connection may also be formed between the lateral edges of the conductive traces 611, 612 and the sidewalls of the electrode 350. In some embodiments, the electrode 350 (e.g., a hydrogel electrode or any suitable electrode) may be formed in situ within the central aperture and / or expanded within the central aperture 617. Electrode 350 can be expanded to a diameter slightly larger than that of the central hole 617 so that the compressive force can make full contact between trace layer 609 and electrode 350.

[0149] Figure 10A An example of trace layer 609 is shown. Figure 10B Depicting Figure 10A A close-up of image A in the middle. (As shown) Figure 10A As shown, the connection portion of the trace layer 609 can substantially bisect the electrode interface portion 310 of the hydrogel electrode 350 and / or traces 611, 612. The traces 611, 612 can be substantially linear along the connection portion of the trace layer 609, such as... Figure 10AAs shown. In some embodiments, one or more of the electrical traces 611, 612 may include multiple bends. Multiple bends may produce a zigzag or accordion-like structure, which allows one or more of the electrical traces 611, 612 to better absorb tensile and / or compressive strain along the longitudinal axis. Figure 10C Another example of trace layer 609 is shown. (e.g.) Figure 10C As shown, the trace layer 609 may not be symmetrical about the horizontal and / or vertical axes. In some embodiments, the electrode interface portion 310 of one trace 611 may be configured to be higher on the patient's body than the electrode interface portion 310 of another trace 612. The electrode interface portion 310 may extend along the connection portion of the trace layer 609 in a lateral direction parallel to the horizontal axis, away from portions of traces 611 and 612. The electrode interface portion 310 may extend in the opposite direction, away from the connection portion. In some embodiments, the entire trace 611 may be configured to be higher on the patient's body than the opposing trace 612, such as... Figure 10C As shown. The connecting portions of trace layer 609 can be substantially parallel but can be offset along the horizontal axis so that the connecting portions are not collinear. In some embodiments, both connecting portions can be offset and the electrode interface portions 310 of different traces 611, 612 can extend in opposite directions, such as Figure 10C As shown. The lateral offset of electrode 350 along the horizontal axis can be configured as follows. Figures 9A to 9F The electrodes are positioned appropriately, while allowing the horizontal axis to remain parallel to the patient's height.

[0150] In some embodiments, one or more of the electrode interface portions 310 of traces 611, 612 may be configured as a loop of trace layer 609 extending 360 degrees to surround the central hole 617. The trace layer 609 along the loop may include a substantially uniform width, which may be the same as the width of the trace layer 609 along the connection portion. In some embodiments, the width may be non-uniform. The electrical traces 611, 612 may extend along the entire circumference of the loop or may extend only partially along the loop, such that the electrical traces 611, 612 do not form a closed loop with themselves.

[0151] In some embodiments, the physiological monitoring device 100 may include a battery terminal connector 650 configured to physically connect two opposing terminals of a battery. Figures 11A to 11E Two examples of the battery terminal connector 650 are schematically depicted. Figure 11B The inner surface of a battery terminal connector 650 configured to contact battery terminals is depicted, and Figure 11A Depicting and Figure 11B The surface depicted is the outer surface of the battery terminal connector 650. Figure 11D The inner surface of another example of a battery terminal connector 650 configured to contact battery terminals is depicted, and Figure 11CDepicting and Figure 11D The surface depicted is the outer surface of the battery terminal connector 650. Figure 11E A contour view of a battery 160 to which a battery terminal connector 650 is attached (e.g., adhered). The battery terminal connector 650 may be configured to electrically connect to each of the terminals of the battery 160 and functionally reposition to the electrical path of the battery terminals. The battery terminal connector 650 may be configured to connect to the terminals of a button cell battery or a battery having one terminal on the top side and the opposite terminal on the bottom side, including opposing front and bottom sides. In some embodiments, the battery terminal connector 650 may be configured to provide electrical path for both terminals of the battery on one side (e.g., the front) to simplify electrical connection of each terminal to the PCBA 120. Therefore, the battery terminal connector 650 may include a first portion 655 (e.g., bottom), a top 657 (e.g., top), and a connecting portion 656 connecting the first portion 655 and the second portion 657. At least the connecting portion 656 of the battery terminal connector 650 may be flexible enough that the connecting portion 656 can be bent, folded, or wrapped around the side of the battery 160 between the top and bottom surfaces of the battery 160.

[0152] The battery terminal connector 650 may include an insulating layer 651 and two conductive battery traces 652, 653. Each of the battery traces 652, 653 may be configured to contact one of the two battery terminals. The insulating layer 651 may be configured to keep the two battery traces 652, 653 separated, thereby insulating the battery traces 652, 653 from each other. The insulating layer 651 may be configured to prevent at least one of the battery traces 652, 653 from contacting the battery terminal of the other battery trace. The insulating layer 651 may be formed of a non-conductive material. For example, the insulating layer 651 may include polyethylene, such as polyethylene terephthalate (PET) or other suitable non-conductive polymers. The battery traces 652, 653 may be formed of a highly conductive material configured to electrically connect the battery terminals to the circuitry of the physiological monitoring device 100. For example, the battery traces 652, 653 may include silver or copper (e.g., tin-plated copper foil). A conductive adhesive (e.g., a conductive acrylic adhesive) can be used to adhere at least a portion of the inner surface of the battery terminal connector 650 to the battery terminals, the conductive adhesive being configured to electrically connect each of the battery terminals to one of the battery traces 652, 653.

[0153] The battery terminal connector 650 may include any suitable arrangement of battery traces 652, 653 and an insulating layer 651. In various embodiments, one of the battery traces 652 may extend from a first side (e.g., the bottom side) of the battery to a second side (e.g., the front side) of the battery. The first battery trace 652 may be exposed on the inner surface of the battery terminal connector 650 on the first side of the battery 160 and only on the outer surface of the battery terminal connector 650 on the second side of the battery 160. The second battery trace 653 may be provided only on the second side of the battery 160. The second battery trace 653 may be exposed on both the inner and outer surfaces of the battery terminal connector 650 on the second side of the battery 160. The PCBA 120 may be configured to form electrical contact with the two battery traces 652, 653 on the outer surface of the battery terminal connector 650 as described elsewhere herein. The insulating layer 651 may be provided at least on the second side of the battery 160 to separate the battery traces 652, 653 on the second side of the battery 160 and to insulate the first battery trace 652 from the battery terminals on the second side of the battery 160. In an embodiment, the insulating layer 651 may be disposed along the connection portion 656 and / or along at least a portion (e.g., the bottom) of the first side of the battery 160 on the inner surface of the battery terminal connector 650. The insulating layer 651 may also be disposed along the connection portion 656 and / or the first side (e.g., the bottom) of the battery 160 on the outer surface of the battery terminal connector 650.

[0154] Return to Figures 11A to 11B In some embodiments, the second battery trace 653 may be disposed (e.g., printed or otherwise suitable) on the outer surface of the battery terminal connector 650, but may include an extension 654 extending beyond the edge of the insulating layer 651, such that the battery terminals on the second side of the battery 160 can electrically contact the extension 654 of the second battery trace 653 and current can be transmitted to the outer surface of the battery terminal connector 650 via the extension 654. In some embodiments, such as Figures 11C to 11D As shown, a second battery trace 653 may be disposed (e.g., printed) on the inner and outer surfaces of the battery terminal connector 650. The second battery trace 653 may be sandwiched within a portion of the insulating layer 651. The battery terminal connector 650 may include a through-hole filled with a conductive material to form a through-hole electrically connecting the second battery trace 653 on the inner and outer surfaces of the battery terminal connector, allowing current to be transmitted through the battery terminal connector 650 from a second side of the battery to the outer surface of the battery terminal connector 650. In some embodiments, the through-hole may also electrically connect a first battery trace 652 between the inner and outer surfaces of the battery terminal connector 650. In addition to the conductive through-hole 619 disclosed herein, conductive rivets may also be used. Figures 11F to 11I An example of a battery terminal connector 650 configured to contact battery terminals is depicted. Figure 11F Depicting the application of a non-conductive coating and / or layer 658 (such as...) Figure 11H (As shown) the outer surface of the previous battery terminal connector 650, while Figure 11G The inner surface of the battery terminal connector 650 before the addition of adhesive 660 is depicted (e.g., Figure 11I (As shown). In some embodiments, the second non-conductive layer 658 may cover the first battery trace 652 and the connection portion 656 on the outer surface of the battery terminal connector 650. In some embodiments, the battery terminal connector 650 may have at least one protrusion 659 to positionally secure the battery terminal connector and battery assembly within the device housing. There may be one, two, three, four, or more protrusions. Those skilled in the art will understand that the protrusions may be shaped in any suitable manner, such as curved or angular shapes.

[0155] Figures 12A to 12G A multi-view diagram showing another example of the upper housing 640. Figure 12A A partial exploded view of the upper housing 640 is depicted. In some embodiments, the upper housing 640 may have a circular, oval, oblong, rectangular, square, or any other suitable profile shape in a horizontal plane. The upper housing 640 may include a flexible upper frame 642 and a rigid shell 643. Figure 12B A perspective view of the flexible upper frame 642 is shown. Figure 12C A contour diagram of the flexible upper frame 642 is shown. Figure 12D A top view of the flexible upper frame 642 is shown. The rigid shell 643 can be more rigid than the flexible upper frame 642. For example, the rigid shell 643 can be made of a hard plastic (e.g., polycarbonate, such as Makrolon). TM The flexible upper frame 642 can be formed from a softer rubber (e.g., Santoprene). TM The upper housing 640 may include a button 644 that forms at least a portion of the upper surface of the upper housing 640 and surrounds the internal components of the housing 615 from above. The button 644 may be a separate piece assembled with the flexible upper frame 642 and the rigid shell 643 to form the upper housing 640, such as... Figure 12AAs shown. Button 644 can be relatively more rigid relative to the flexible upper frame 642. In some embodiments, button 644 can be formed of the same material as the rigid shell 643. Button 644 can be securely attached to the flexible upper frame 642 by any suitable means (e.g., using an adhesive, a stopper, a slide-in fit, etc.) such that button 644 is configured as a "floating" button above the internal space of the upper shell 640. In some embodiments, the flexible upper frame 642 can be overmolded onto at least a portion of the upper and lower surfaces of button 644. Overmolding can be used to secure button 644 to the rigid shell 643. In some embodiments, button 644 can be completely encapsulated within the flexible upper frame 642.

[0156] Rigid shell 643 may form the side surface (e.g., circumferential) of upper shell 640, such as Figure 12A As shown. Figure 12A As shown, a rigid shell 643 may form an outer annular portion or outer periphery of the upper surface of the upper shell 640. A flexible upper frame 642 may be overmolded onto the rigid shell 643. The flexible upper frame 642 may connect the rigid shell 643 to the button 644 as described elsewhere herein. The flexible upper frame 642 may fill the annular gap in the upper surface of the upper shell 640 between the outer periphery formed by the rigid shell 643 and the button 644, thereby forming a flexible boundary of the button 644. The flexible upper frame 642 may be configured to bias in a manner that allows the button 644 to be pressed down relative to the rigid shell 643 to actuate the trigger 210. In some embodiments, the lower surface of the button 644 may be formed with a convex surface or other lug configured to actuate the trigger input 210. In some embodiments, the lug (e.g., a dome, a pillar, or any suitable shape) may be attached to the lower surface of the button 644. The lug may facilitate trigger actuation such that actuating the trigger input 210 requires less stress. The lug may be made of metal and / or plastic.

[0157] In some embodiments, button 644 may be configured as a cantilever button instead of a floating button, wherein the cantilever button 644 is connected to the side (e.g., inner diameter) of the rigid housing 643. The flexible upper frame 642 may conceal the cantilever, such that button 644 still appears as a floating button externally. In some embodiments, button 644 may not be a floating button, but may be integral with or directly connected to the rigid housing 643. Button 644 may be semi-rigid but contain sufficient flexibility for button 644 to elastically deform. Button 644 may include protruding and / or projecting features (e.g., dome-shaped features) when unbiased. Button 644 may be configured such that the shape of button 644 can elastically deform to actuate trigger input 210. For example, the dome may be at least partially inverted at or near the apex of the dome, such that the center of the dome button 644 extends downward within the space enclosed by the upper housing 640 to actuate trigger input 210. In some embodiments, upon reaching a threshold stress, the dome may concave or bend into an inverted configuration, in which less pressure is required to continue pressing the dome down. The bending or concave effect can be configured to provide a useful tactile indication of trigger 210 actuation. In some embodiments, upon releasing pressure, the dome may spring back to its unbiased configuration. In some embodiments, the dome button 644 may comprise a conductive material or be coated as a conductive surface, and the dome body may directly contact electrical terminals on the PCBA 120 to actuate the trigger input without requiring an additional trigger input button 210 on the PCBA. In some embodiments, the button 644 may be rigid but attached to a resiliently deformable snap dome that directly contacts electrical terminals on the PCBA 120 while providing tactile feedback to the user. In some embodiments, the semi-rigid button 644 may snap into a rigid housing 643, such as via a lip seal (the button 644 may be attached to an O-ring). In some embodiments, the button 644 may be ultrasonically welded or sealed to the rigid housing 643. In some embodiments, button 644 may be formed as a thinned portion of the upper surface of rigid shell 643. In some embodiments, button 644 may be formed of a soft material, such as a thermoplastic elastomer, configured to fold, bend, and / or spring back. Button 644 may include a hard outer surface mounted on the softer material for a user to press and / or a hard inner surface mounted on the softer material to contact trigger input 210. In some embodiments, the softer material for contacting the trigger input may include a soft conductive element (such as conductive foam pellets) that actuates the trigger input by short-circuiting a pad or trace on the PCBA, without requiring a de facto button assembly on the PCBA. In some embodiments, button 644 may be configured similarly to a computer keyboard button.For example, button 644 may be configured to be in a biased, non-contact position on one or more support members surrounding trigger input 210 and holding button 644 above trigger input 210. In some embodiments, an electrical signal indicating button press may be generated via a printed circuit board, via flexible circuitry attached to the button, or via electrical traces applied to rigid housing 643. These electrical traces may be applied via laser direct forming, electroplated onto a plated substrate used in a secondary forming process, or printed via air jet printing, inkjet printing, or screen printing with conductive materials.

[0158] The flexible upper frame 642 may include an upper edge 642a and a lower edge 642b configured to intersect with the top surface of the rigid shell 643 as described elsewhere herein. The lower edge 642b may include a larger diameter than the upper edge 642a. The upper edge 642a and / or the lower edge 642b may include an annular (e.g., ring-shaped) configuration. The lower edge 642b may be configured to intersect with the lower surface of the lateral sidewall of the rigid shell 643 (e.g., via overmolding or snap-fit). The inner diameter of the lower edge 642b may be configured to intersect with the outer diameter of the PCBA 120 (e.g., via snap-fit). The lower edge 642b may functionally connect the PCBA 120 to the rigid shell 643. In some embodiments, the lower edge 642b may have substantially the same rigidity as the upper edge 642a. In some embodiments, the lower edge 642b may be more rigid than the upper edge 642a. The upper edge 642a may be connected to the lower edge 642b by one or more vertical ribs 642c. Multiple ribs 642c may be spaced apart (e.g., substantially uniformly) around the periphery of the upper housing 640. Ribs 642c help retain the PCBA 120 within the upper housing. In some embodiments, the PCBA 120 may be configured such that a recess in the peripheral edge of the PCBA 120 at least partially accommodates one or more ribs 642c. Ribs 642c may at least partially conform to the shape of the PCBA 120. Ribs 642c help absorb vibrations that would otherwise be transmitted to the PCBA 120 and may potentially cause motion artifacts, for example. Some ribs 642c may not connect the upper edge 642a and the lower edge 642b. Figures 12B to 12D As shown, some ribs 642c may extend upward from the bottom edge 642b but are not attached to the upper edge 642a. Some ribs 642c may extend downward from the upper edge 642a but are not attached to the lower edge 642b. In some embodiments, only a single rib 642c connects the upper edge 642a and the lower edge 642b, as shown. Figures 12B to 12D As shown. In some embodiments, the upper edge may not be connected to the lower edge, or one of the two loops may be omitted entirely.

[0159] In some embodiments, one or more connecting ribs 642c may be distributed circumferentially relative to the trigger input 210. One or more connecting ribs and / or frame 642 may serve as fulcrums or pivot points around which the upper edge 642a and button 644 are pressed down. Such a fulcrum arrangement may allow deeper pressing of the button 644 on the side of PCBA 120 containing the trigger input 210. In some embodiments, one or more support rods may extend vertically upward below the button 644 (e.g., from PCBA 120). The support rods may be spaced apart around the periphery below the lower surface of the button 644. The height of the support rods may be lower than the height of the trigger input 210. If the lower surface of the button 644 contacts the support rod, the support rod can act as a fulcrum and help to bias the lower surface of the button 644 toward the trigger input 210 when the button 644 is pressed. The support rods may be particularly useful if the trigger input is off-center from the center of the button 644 (e.g., around the periphery of PCBA 120). In some embodiments, the upper edge 642a of the flexible upper frame 642 may be filled to form a continuous region, such that the upper frame 642 may include an upper surface flush with the upper surface of the rigid shell 643 and covering the central portion of the upper surface of the upper shell 640. In some embodiments, the button 644 may be formed as an integral part of the flexible upper frame 642 and may be substantially the same or less rigid than the rest of the flexible upper frame 642. In some embodiments, the button 644 (which may be flexible or rigid) may be coupled to the upper surface of the flexible upper frame 644 (e.g., below the upper surface). The button 644 may be attached to the upper surface of the upper frame 642 (which may be flexible or rigid) via snap-fit, barb engagement, adhesive, suction, etc. In some embodiments, to minimize the possibility of PCBA bending during force application to the input trigger via the button, the upper shell 640 may include a stop that limits the range of motion of the button 644 to minimize stress on the board. Such stoppers can also be implemented as components on PCBAs, for example as non-active molded components press-fitted onto the PCBA or active components, such as antennas soldered to the board but intentionally extended to limit the range of motion of buttons.

[0160] Figure 12EA perspective view depicting the inner surface of the upper housing 640 is shown. In some embodiments, the upper housing 640 may include downwardly extending posts 641 configured to secure the upper housing 640 to or assist in securing the upper housing 640 to the lower housing 645. The posts 641 may be spaced apart (e.g., substantially uniformly) around the periphery of the upper housing 640. The posts 641 may have channels configured to receive and retain rods 646 extending from the lower housing 645, as described elsewhere herein (e.g., via press fit or interference fit). The posts 641 may be formed as part of a rigid housing 643. The posts 641 may be integrally formed with the rigid housing 643. The posts 641 may be located inside the lower edge 642b of the flexible upper frame and / or housing 640. Figure 12E As shown, one or more pillars 641 can be integrated with the inner diameter of the rigid shell 643. One or more pillars 641 can be spaced inwardly from the inner radial direction of the rigid shell 643. Figure 12E As shown, column 641 can extend to a height higher than the inner diameter of upper shell 640, to a height approximately the same as the inner diameter of upper shell 640, or lower than the inner diameter of upper shell 640. Flexible upper frame 642 can extend to a height higher than the inner diameter of rigid shell 643, to a height approximately the same as the inner diameter of rigid shell 643, or lower than the inner diameter of rigid shell 643, such as... Figure 12E As shown. In some embodiments, as described above, button 644 can be bent as an integrated part of the housing and / or shell 643. In such embodiments, the upper edge 642a is no longer needed. A window can be added to button 644, which is covered with a thin layer of translucent material, to allow light transmission from the LED below.

[0161] like Figure 12F As shown, the top 714 and bottom 716 portions of the housing can be located above and below the flexible body 718. As shown in Figure 6D2, in an embodiment, a gasket 719 can be located between the upper housing 714 and the lower housing 716, which are co-molded into one or more housings. The gasket can be pressed downwards against the adhesive assembly and the ridged interface (as shown below). Figure 12G (As shown) or another gasket on the opposite housing to provide waterproofing for the internal electronic hardware. Figure 12GAs depicted, ridge 721 may be located on the upper edge of the lower housing 716, and ridge 721 is configured to be pressed into the adhesive layer and / or gasket 719. Those skilled in the art will understand that ridge 721 can be any suitable shape, such as a ridged ridge as depicted in Figure 721. In some examples, the ridge may be round, square, and / or polygonal. In some examples, the height of the ridge may be about 0.01 mm to 0.5 mm, about 0.05 mm to 0.4 mm, about 0.1 mm to 0.3 mm, about 0.1 mm to 0.2 mm, or about 0.15 mm, such as about 0.13 mm.

[0162] Figures 13A to 13B A multi-view diagram showing another example of the lower housing 645. The lower housing 645 can be configured to engage with the upper housing 640. Figure 13A A perspective view of the lower casing 645 is depicted, while Figure 13BA contour view of the lower housing 645 is depicted. In some embodiments, the lower housing 645 may include a plurality of rods 646 extending upward from the body of the lower housing 645 beyond an upper peripheral edge configured to intersect the lower peripheral edge of the upper housing 640. The rods 646 may be configured to extend into the interior space enclosed by the upper housing 640. In other embodiments, the rods 646 may not extend beyond the upper peripheral edge of the lower housing 645. In some embodiments, the rods 646 may be configured to pass through holes 616 in the trace layer 609 and may assist in securing the trace layer 609 to the lower housing 645, as described elsewhere herein. The plurality of rods 646 may be configured to be received therein and to mate with an equal number of posts 641 in the upper housing 640 opposite to the rods 646. For example, the plurality of rods 646 may be configured to form a press fit or interference fit with the plurality of posts 641, such that the rods 646 and posts 641 are configured to secure or lock the upper housing 640 and the lower housing 645 together. The engagement between lever 646 and post 641 resists the separation force between upper housing 640 and lower housing 645. This separation force can be caused by spring 665 (described elsewhere herein), the reaction force of a gasket compression between upper and lower housings 640 to form a water seal, forces transmitted from upper housing 640 to lower housing 645 during trigger 210 actuation, etc. In some embodiments, some or all of levers 646 may be arranged on upper housing 640 and some or all of posts 641 may be arranged on lower housing 645. In some embodiments, lower housing 645 may include one or more snap-on posts configured to contact the bottom surface of PCBA 120 (or a spring contact gasket as described elsewhere herein). The snap-on posts may be configured to securely contact PCBA 120 with upper housing 640, withstand PCBA 120 thickness tolerances, and / or provide additional rigidity to elicit a strong tactile response to pressure on button 644. In one embodiment, the lower housing 645 can be connected to the upper housing 645 via an alternative process such as ultrasonic welding, potentially eliminating the need for a press-fit rod.

[0163] In some embodiments, housing 115 may include spring 665, configured to provide a consistent force that biases the internal components enclosed by housing 115 into contact with each other. Spring 665 typically biases the components toward the top and / or bottom of housing 115. Spring 665 can absorb tolerance overlaps of the internal components and maintain substantially consistent bias and vertical position or spacing between components, regardless of minor variations in the dimensions of the various internal components or their mating relative to each other. Spring 665 can bias PCBA 120 into contact with a hard stop formed in the upper housing 640, enabling the PCBA to provide a reaction force against button press pressure and allow actuation of input trigger 210. In some embodiments, spring 665 may be a wave spring, although other types of springs (e.g., helical springs) may also be used. In some embodiments, spring 665 may be replaced by an elastic foam that provides damping characteristics in addition to those described above. Figures 14A to 14B An orthogonal profile diagram of an example wave spring 665 is shown. The wave spring 665 may be configured to be disposed substantially along the inner diameter of the housing 115. In some embodiments, the spring 665 may be configured to be disposed in the bottom of the lower housing 145 and to bias internal components toward the upper housing 140, as described elsewhere herein.

[0164] Figures 15A to 15I Several views are shown illustrating another example of a physiological monitoring device 600. The physiological monitoring device 600 may include one or more components described elsewhere herein. The physiological monitoring device 600 may include a housing 615 comprising an upper housing 640 and a lower housing 645 configured to mate together to clamp a flexible body 610 between the upper housing 640 and the lower housing 645. The flexible body 610 may include a trace layer 609 and one or more base layers forming wings of the physiological monitoring device 600. As described elsewhere herein, the wings may include an adhesion layer 340 and electrodes 350. The rigid body and / or housing 615 may surround a PCBA 120, a flexible upper frame 642, a battery 160, a battery terminal connector 650, a portion of the trace layer 609, a spring contact pad 632, and a spring 665.

[0165] Figure 15A A perspective view depicting an embodiment of the physiological monitoring device 600 is shown. Figure 15B An exploded view of the physiological monitoring device 600 is depicted. Figure 15C A outline view of a rigid housing 643 with the upper housing 640 and the button 644 removed is depicted. Figure 15D Describing as Figure 15C The outline of the housing 615 with the additional flexible upper frame 642 removed is shown. Figure 15E Describing as Figure 15DThe diagram shown is a profile of the housing 615 with the additional flexible lower frame 645 removed. Figure 15F Describing as Figure 15E The diagram shown is a outline of the housing 615 with the battery 160 and spring 665 removed. Figure 15G Describing as Figure 15F The cross-sectional view of the housing shown is taken between the circuit board 120 and the spring contact pad 632. Figure 15H Describing as Figure 15G The diagram shown is a cross-sectional view of the housing with the additional spring contact pad 632 removed. Figure 15I It also describes other components, such as PCBA120. Figure 15H The outline of the housing 615 is shown.

[0166] The upper housing 640 and the lower housing 645 may sandwich the flexible body 610, as described elsewhere herein. In some embodiments, the flexible body 610 may include one or more orifices 332 extending through one or more base layers to provide breathability and moisture management and / or facilitate drug delivery to the skin surface, as described elsewhere herein. An upper gasket layer 360 and / or a lower gasket layer 370 (not shown) may be disposed on opposite sides of the flexible body 610 (not shown). Gasket layers 360, 370 may be adhesive to adhere to the flexible body 610. A compressible seal may be formed above and / or below the flexible body 610. In some embodiments, the compressible seal may be formed via a flexible upper frame 642. The battery 160 may be located below the flexible body 610 including the trace layer 609. The PCBA 120 may be located above the flexible body 610 including the trace layer 609. The battery terminal connector 650 can be adhesively or otherwise coupled to the battery 160, such that the first battery trace 652 and the second battery trace 653 are exposed on the outer surface of the battery terminal connector 650 on the front side of the battery 160. For example... Figure 15H As shown, the first battery trace 652 and the second battery trace 653 can be exposed to the internal volume of the upper housing 640 through the large central opening in the housing region of the trace layer 609.

[0167] Electrical contact between PCBA120 and the first battery trace 652 and the second battery trace 653, and / or electrical contact between PCBA120 and the ECG interface 313 of electrical traces 611 and 612, can be established by spring contact 637, such as... Figures 15G to 15I As shown. Figure 15I As shown, spring contact 637 can be coupled to the bottom surface of PCBA 120. Housing 615 may include spring contact pad 632 located below PCBA 120. Figure 15I(Not shown in the image). In some embodiments, the spring contact pad 632 may be rigidly fixed (e.g., adhered) to the bottom of the PCBA 120. In embodiments, the spring contact pad may be attached to or integrated into the flexible body 610. In some embodiments, the spring contact pad may be integrated into a battery terminal connector. The spring contact pad 632 may include a flat body and a plurality of downwardly extending support posts 633. Figure 15E As shown, the support column 633 can be configured to abut against the upper surface and / or side surface of the battery 160, such that the spring contact pad 632 maintains a minimum spacing between the battery 160 and the PCBA 120 and provides sufficient space for the spring contact 637. Figure 15G As shown, the spring contact pad 632 may include one or more holes 634 through which the spring contact 637 may extend downward from the bottom surface of the PCBA 120. Figure 15E As shown, the lower housing 645 may include a spring 665, as described elsewhere herein, located below the battery 160. The spring 665 can bias the battery 160 upwards and can bias the first battery trace 652 and the second battery trace 653 into physical and electrical contact with their respective spring contacts 637. The ECG interface 313 of the traces 611, 612 may be located on the front side of the battery 160, such that the upward bias of the battery 160 also biases the ECG interface 313 of the traces 611, 612 into physical and electrical contact with their respective spring contacts 637. The substantially consistent spacing between the traces and PCBA 120 provided by the spring 665 and the spring contact pad 632 can reduce, minimize, or eliminate noise in the electrical signal caused by fluctuations in the electrical contact between the spring contacts 637 and the traces. The assembly may include at least one spring contact 637 for each of the first battery trace 652, the second battery trace 653, the first electrical trace 611, and the second electrical trace 612. The components may include more than one spring contact 637 for some or all of the traces. The spring contacts 637 may be configured under compression caused by the arrangement of various components including spring 665 to establish an electrical path between each trace and PCBA 120. Because the spring contacts 637 can extend further downwards if the spacing distance increases and the bias decreases accordingly, the compressive contact between the spring contacts 637 and the trace can be maintained even if the nominal spacing distance between the trace and PCBA 120 changes (e.g., due to movement). In some embodiments, such as Figure 15HAs shown, the first battery trace 652 and the second battery trace 653 can be configured to be located on the opposite side of the housing 615 from the first trace 611 and the second trace 612. In other embodiments, spring contacts can be configured to carry electrical signals or electrocardiogram signals from the battery by contacting traces applied to the upper housing 640 or the bottom housing 645. These traces can be applied to the housing by using laser direct forming, electroplating onto an electroplatable substrate applied in a secondary forming process, or printing via air jet printing, inkjet printing, or screen printing with conductive materials. In other embodiments, such traces can be used in the top housing 640 or the bottom housing 645 to construct RF antennas for wireless communication (such as Bluetooth).

[0168] Figures 16A to 16D Depicting something similar to Figures 10A to 15I Such as Figure 15A Several views of an embodiment of a physiological monitoring device 800 depicted herein. Here, the physiological monitoring device includes a central housing 802, which includes an upper housing 802 and a lower housing 806 sandwiched on a flexible substrate 810. Those skilled in the art will understand that the housings can be made of any suitable material disclosed herein, such as rigid polymers or soft, flexible polymers. In some embodiments, the housing may include an indicator 808, which can be of any suitable shape, such as elliptical, circular, square, or rectangular. The indicator may include an LED light source (not shown) or any suitable light source, which may be covered by a transparent or translucent observation layer abutting the inner surface of the upper housing. The observation layer may be made of thermoplastic polyurethane or any suitable material. The indicator can be used to indicate the status of the physiological monitoring device, such as the battery life of the physiological monitoring device. In some embodiments, the indicator can indicate whether the physiological monitoring device is collecting data, transmitting data, paused, encountering an error, or analyzing data. The indicator can display any suitable color, such as red, amber, or green.

[0169] Extending outward from the housing are multiple wings 812. Those skilled in the art will understand that while two wings are depicted herein, other embodiments of the physiological monitoring device 800 may include more than two wings. As described elsewhere in the specification, the wings may be formed in such a manner as to improve adhesion to the skin and retention of the physiological monitoring device on the skin. In embodiments, the wings may be asymmetrical, with a larger portion of one wing (upper lobe) 814 positioned above the longitudinal line, while a larger portion of the other wing (lower lobe) 816 is positioned below the longitudinal line, thereby allowing the physiological monitoring device to be placed diagonally above the heart so that the lower lobe is positioned below the heart when the patient is in a standing position.

[0170] Electrode traces similar to those described elsewhere in this specification, such as those relative to... Figures 10A to 10C and Figure 15A Electrode traces 818 extend outward from the housing and are contained on or within the wing. As described elsewhere in the specification, the electrode traces can be printed directly onto a flexible substrate, which may be part of a multilayer flexible assembly 820. Additional printed lines 822 may surround the electrode traces 818 to visually enhance the physiological monitoring device; however, the printed lines 822 may be printed on a different layer than the flexible substrate on which the electrode traces are printed. The printed lines may be printed such that they blend into the shape of the electrode traces. As described elsewhere in the specification, the electrode traces may surround a series of breathing holes 824 that allow air to pass through to the underlying hydrogel. In embodiments, there may be one, two, three, four, or more breathing holes. As described elsewhere in the specification, holes 826 may extend through one or more layers of the physiological monitoring device to provide breathability and moisture management. In embodiments, an adhesive boundary layer 828 may extend outward from the wing, thereby allowing for improved adhesion. Figure 16B Depicting Figure 16A The bottom surface of the physiological monitoring device 800 is depicted in the image. Here, the lower housing 806 and the electrode traces 818 and printed lines 822 extending outward from the housing are clearly visible. Figure 16C and Figure 16D Depicting Figures 16A to 16B The physiological monitoring device 800 includes an externally facing top liner 826 covering the wings and surrounding the housing 802, and a skin-facing patient release liner 828. This release liner is used to protect the physiological monitoring device 800 during storage, particularly to protect the adhesive surfaces of the physiological monitoring device. In an embodiment, the liner may be formed such that the two sides meet to form an opening through which the housing extends vertically.

[0171] In some embodiments, a dermabrasion tool may be used to abrade the patient's skin before the physiological monitoring devices 100, 600, 800 (e.g., described elsewhere in this specification) are adhered to the patient. The dermabrasion tool may be used to remove the patient's superficial skin to improve long-term adhesion of the physiological monitoring devices 100, 600 and / or the signal quality from the physiological monitoring devices 100, 600. Figure 17A and Figure 17BCross-sectional views of two examples of a dermabrasion 700 are schematically shown. The dermabrasion 700 may include a housing 702. The housing 702 may serve as a handle through which a patient or other person may grip and operate the dermabrasion 700. In some embodiments, additional elements, such as an elongated handle, may extend from or otherwise attach to the housing 702. The dermabrasion 700 may include a substantially flat abrasion surface 704 for abrading the skin. The abrasion surface 704 may include a generally large surface area. The abrasion surface 704 may include a rough surface and / or protrusions for abrading the skin. In some embodiments, the housing 702 may completely or substantially circumferentially surround the abrasion surface 704, such as... Figure 17A and Figure 17B As depicted in [the text]. During the polishing process, the housing 702 can substantially surround the polishing surface 704. The polishing surface 704 can be coupled to the housing 702 via a compressible member or biasing element 706. In some embodiments, the compressible member 706 can be as follows: Figure 17A The spring shown. In some embodiments, the compressible member 706 may be as follows: Figure 17B The compressible foam is shown. The polished surface 704 can be configured to protrude beyond the bottom surface of the housing 702 in an unbiased configuration.

[0172] The amount of abrasion can depend on the amount of pressure applied to the abrader 700. Greater pressure may cause increased friction between the abrader 700 and the patient's skin, resulting in more vigorous abrasion. Too much pressure may cause discomfort or pain to the patient during and / or after the abrasion. Too little pressure may result in insufficient abrasion. The compressible element 706 can help the user adjust the amount of pressure applied to the abrader 700. The abrader 700 can be configured such that applying pressure exceeding a desired pressure threshold will cause the compressible element 706 to be sufficiently biased to retract into the housing 702 and no longer contact the skin. In some embodiments, the abrader 700 can be finely adjusted such that when the bottom of the housing 702 is pressed down and in contact with the skin, the abrader 700 deforms the skin enclosed by the housing 702 to a degree that the abrasion surface 704 can still contact the skin. The compressible element 706 can provide an adjusted magnitude of force at this level of compression to achieve the desired degree of abrasion. In some embodiments, the desired amount of abrasion can be achieved when the abrasion surface 704 protrudes completely from the housing 702 so that the housing does not come into direct contact with the skin. In some embodiments, an indicator may be used to indicate to the user that the desired (e.g., sufficient) amount of pressure has been achieved. For example, the foam compressible member 706 may be formed of open-cell foam having an internal color and an external color different from the internal color. The foam may be configured to be visible to the user. For example, the housing may include an annular configuration surrounding the foam compressible member 706 such that the foam compressible member 706 is visible from the top during abrasion, such as... Figure 17BAs depicted in the diagram. When the compressible member 706 is in an unbiased configuration, the internal color of the foam can be visible. The compressible member 706 can be configured such that, upon reaching a threshold level of compression, the opening is sufficiently compressed or closed to make the internal color no longer visible to the user. The color change within the foam can serve as a visual indicator that sufficient pressure has been achieved. The visibility of the internal color can instruct the user that he or she should apply greater pressure.

[0173] In various alternative embodiments, the shape of a particular physiological monitoring device can vary. The shape, footprint, outer edge, or boundary of the device can be, for example, circular, elliptical, triangular, composite curve, etc. In some embodiments, the composite curve may include one or more concave curves and one or more convex curves. The convex shape may be separated by concave portions. The concave portions may be located between the convex portions on the housing and the convex portions on the electrodes. In some embodiments, the concave portions may at least partially correspond to a hinge, hinge area, or region with reduced thickness between the body and the wing.

[0174] Although described in the context of a cardiac monitor, the device improvements described herein are not limited thereto. The improvements described herein can be applied to any of a variety of physiological data monitoring, recording, and / or transmission devices. The improved adhesion design features can also be applied to devices useful in the electronically controlled and / or time-release delivery of pharmaceuticals or blood, such as glucose monitors or other blood detection devices. Thus, the description, characteristics, and functionality of the components described herein can be modified as needed to include application-specific components such as electronics, antennas, power or charging connectors, data ports or connectors for downloading or unloading information from or from the device, adding or unloading fluids from or from the device, monitoring or sensing elements (such as electrodes, probes, or sensors), or any other components required for device-specific functions. Additionally, or alternatively, the devices described herein can be used to detect, record, or transmit signals or information related to signals generated by the body, including but not limited to one or more of ECG, EEG, and / or EMG. In some embodiments, additional data channels may be included to collect additional data, such as device motion, device bending or folding, heart rate, and / or ambient electrical or acoustic noise.

[0175] The physiological monitors described above and elsewhere in the specification can be further combined with improved data processing and transmission methods and systems for collecting data from the monitors. Furthermore, the methods and systems described below can improve monitor performance by enabling timely transmission of clinical information while maintaining high patient compliance and ease of use of the aforementioned monitors. For example, the data processing and transmission methods and systems described elsewhere in this section of the specification can be used to extend the monitor's battery life, improve its accuracy, and / or provide other improvements and advantages described elsewhere in this section of the specification.

[0176] Device monitoring and clinical analysis platform

[0177] The systems and methods described below can selectively extract, transmit, and analyze electrocardiogram (ECG) signal data and other physiological data from wearable physiological monitors such as those described above. These systems and methods can improve the performance of wearable physiological monitors that simultaneously record and transmit data in multiple ways. For example, because the wearable patch does not need to transmit all recorded data, selective transmission of extracted data allows for reduced power consumption. By sending the extracted data, many analyses can be performed outside the wearable device without requiring highly power-consuming and battery-shortening onboard rhythm analyses. Furthermore, remote analysis without the inherent power limitations of wearable devices can improve the sensitivity and accuracy of data analysis. Reduced power consumption helps improve patient compliance because it extends or even eliminates the time intervals between device replacements, battery replacements, or battery charging during monitoring periods. By reducing battery consumption, longer monitoring times, such as at least one week, at least two weeks, at least three weeks, or more than three weeks, can be achieved without device replacement.

[0178] Figure 18 A general overview of an embodiment of a system 900 for inferring heart rhythm information from an RR interval time series 902 that can be generated by a continuous heart rate monitoring device 904 is depicted. The RR interval time series 902 input to the system may include a series of measurements of the time interval between consecutive heartbeats. Typically, each interval represents the time interval between two consecutive R peaks identified from the ECG signal. An R peak is part of a QRS complex, a combination of three graphical deflections commonly found on an ECG, representing the depolarization of the left and right ventricles of the mammalian heart. The R peak is typically the highest and most pronounced upward deflection on the ECG, and is therefore a suitable reference point. However, in further embodiments, any characteristic ECG reference point (such as QRS complex initiation or offset) may be used instead of the R peak to provide an estimate of the RR interval time series. As described above with respect to Figures 1 through 9 and throughout the specification, the physical characteristics of the monitoring device are constructed in a manner that enhances signal fidelity, thus allowing for high confidence in the accurate extraction of RR peak data.

[0179] The RR interval time series 902 data can be extracted or received from a dedicated heart rate monitor, such as a heart rate chest strap or heart rate watch, or from wearable health or fitness devices 906, 908 that incorporate heart rate sensing capabilities. Optionally, the RR interval time series 902 can be derived from a wearable patch 904 designed to measure ECG signals (e.g., by locating the R peak in the ECG using a QRS detection algorithm). Furthermore, the RR interval time series 902 can be estimated based on alternative physiological signals, such as signals obtained from photoplethysmography (PPG). In this case, the peak-to-peak interval time series determined from the PPG signal can be used as an accurate estimate of the RR interval time series.

[0180] On one hand, the heart rhythm inference system 910 is implemented as a cloud service or a server-based system, which exposes RR interval time series data or other signal data that can be transmitted to the system (e.g., via HTTP) and allows the generated heart rhythm information to be returned to the application programming interface (API) that calls the software. RR interval time series data 902 or other signal data can be transmitted directly from the heart rate monitoring device itself to the cloud service, or indirectly via a smartphone 912, tablet, or other networked communication device 914 that can receive data wirelessly or wiredly from the heart rate monitoring device. Alternatively, RR interval time series data 902 or other signals can be transmitted from a server 916 that stores data for multiple users.

[0181] In some embodiments, the heart rhythm inference system 910 is provided via a software library that can be incorporated into a standalone application for installation and use on a smartphone, tablet, or personal computer. This library can provide the same functionality as the inference service, but the RR interval time series data 902 or other signal data is transmitted directly via function calls, rather than through a network service API.

[0182] In some embodiments, in addition to a single RR interval time series 902, the heart rhythm inference system may also accept multiple RR interval time series 918 measured from a given user's device. In this case, the system calculates the frequency and duration of each heart rhythm type inferred from the set of time series data. These results can then be used to estimate a confidence statistic for that heart rhythm based on the frequency and duration of each heart rhythm occurring in the various time series. Additionally, the confidence statistic for the heart rhythm can be updated for each individual invocation sequence of the inference service. Furthermore, in some embodiments, the heart rhythm information inferred by the system can be provided to the recall software only if the confidence score for a given heart rhythm type exceeds a predetermined threshold.

[0183] In a particular embodiment, the heart rhythm inference system 910 can accept additional data sources, typically described as alternative sensor channels, in addition to RR interval time series data, to improve the accuracy and / or value of the inference results. One additional data source includes user activity time series data, such as data measured simultaneously by a 3-axis accelerometer along with RR interval time series measurements. Additionally, the system can accept other relevant metadata that may contribute to improving the accuracy of heart rhythm analysis, such as user age, gender, monitoring indications, past medical history, medication information, medical history, etc., and information regarding the specific date and time range submitted to the system for each time series. Furthermore, the measuring device can provide a good measurement of beat detection confidence, for example, for each R peak or for consecutive time periods. This confidence measurement will be based on the analysis of recorded signals, which in typical embodiments are not recorded due to storage space and battery power requirements. Finally, in the specific case where the RR interval time series data originates from ECG signals, the system can accept additional signal characteristics calculated based on the ECG. These features can include time series of internal bounce interval measurements (such as QT or PR intervals, or QRS duration) or time series of signal statistics such as the mean, median, standard deviation, or sum of ECG signal sample values ​​over a given time period.

[0184] The above aspects can be used individually or in combination to provide applications that monitor an individual's health, stress, sleep, fitness, and / or other qualities.

[0185] Some embodiments relate to systems for selectively transmitting electrocardiogram (ECG) signal data from wearable medical sensors. Current wearable sensors, such as the iRhythm ZioPatch™ 904, and the wearable sensors further described above with reference to Figures 1 through 9, are capable of recording single-lead ECG signals for up to two weeks on a single battery charge. However, in many cases, it is desirable for the sensor to transmit specific portions of the recorded, clinically relevant ECG signals in real-time or near real-time to a computer device, such as a smartphone 912, or a networked gateway device 914 for subsequent processing and analysis. This allows potentially valuable diagnostic ECG information to be provided to the patient or their physician while the patient is wearing the sensor.

[0186] As mentioned above, a significant challenge with this approach is managing the battery life of wearable sensors without replacement or charging, which reduces user compliance. Each time an ECG is transmitted from the sensor to a smartphone or local gateway device (e.g., using Bluetooth Low Energy), the total amount of electricity stored in the sensor's battery subsequently decreases. Some embodiments of this disclosure, particularly those of Figures 17 through 24, address this issue by using novel hardware and software combinations to selectively transmit clinically relevant portions of an ECG from a wearable sensor.

[0187] In some embodiments, the wearable sensor includes a software, hardware, or hybrid QRS detector that generates a real-time estimate of the position of each R-peak in the ECG. The R-peak position data is then used to calculate an RR interval time series, which is subsequently transmitted to a smartphone or gateway device according to a predefined schedule (e.g., once per hour). Additionally, a timestamp storing the start time of the RR interval time series relative to the start of the ECG recording is also transmitted. Because the RR interval time series for a given portion of the ECG is much smaller (in bytes) than the ECG signal itself, it can be transmitted with far less impact on battery life.

[0188] In some embodiments of the second phase of the system, the smartphone or gateway device then transmits the RR interval time series along with a start timestamp to a server. On the server, the RR interval time series is used to infer a list of the most probable heart rhythms within the time period represented by the time series data, along with their start and offset times. The inferred list of heart rhythms is then filtered according to specific criteria, such that only heart rhythms conforming to the given criteria are retained after filtering. Confidence measurements can also be used to help filter events in a way that may improve the positive predictability of the detection.

[0189] In some embodiments of the third phase of the system, for each heart rhythm in the filtered set of heart rhythms, the server transmits the start and offset times of that specific heart rhythm to a smartphone or gateway device. If the estimated duration of the heart rhythm exceeds a predefined maximum duration, the start and offset times can be adjusted so that the resulting duration is less than the maximum allowed duration. The start and offset times received by the gateway are then transmitted to a wearable sensor, which in turn transmits the portion of the recorded ECG signal between the start and offset times back to the gateway. This portion of the ECG is then transmitted to a server that can analyze it and use it to provide diagnostic information to the patient or their doctor.

[0190] In some embodiments, the system essentially allows the device to be worn for approximately 14, 21, or 30 days or longer without charging or replacement (both of which reduce patient compliance and thus diagnostic value) to provide timely notification of asymptomatic arrhythmic events. This development is driven by technological limitations: to achieve a small wearable device that provides high-precision continuous arrhythmia analysis without requiring battery replacement or charging, it is desirable to limit the complexity of onboard analysis. Similarly, without implementing greater power requirements, streaming all recorded ECG data to off-site analysis algorithms may be impractical. This has inspired a more creative “classification” approach where selected features of the recorded ECG signal, including but not limited to the RR interval, are sent with each heartbeat, allowing customized algorithms to pinpoint certain (e.g., 10) 90-second events to request full resolution from the device to support comprehensive analysis, such as clinical diagnostics.

[0191] In other embodiments, the system will provide timely detection of asymptomatic arrhythmias on wearable, adhesive devices that do not require frequent charging or replacement. This would enhance the value of some current clinical services that provide clinical insights only after the records have been completed and returned for analysis.

[0192] In some embodiments, the system will allow actionable clinical insights to be derived from data collected on low-cost, easy-to-use consumer wearable devices that otherwise focus solely on fitness and health. For example, the technology could be used to create a highly effective, low-cost screening tool capable of detecting atrial fibrillation (AF) in the general population. Using such a tool would not only make it easier to identify patients in need of treatment but also allow for earlier and more economical treatment, leading to better outcomes—namely, reducing stroke risk through faster AF identification.

[0193] In a particular embodiment, the system can provide services via a downloadable application that, upon receiving a consumer's consent for data access and payment approval, initiates access to and analysis of heartbeat data stored on the wearable device locally on the mobile device or in an online repository. This data extraction and analysis will be performed via an algorithmic API and will result in clinical findings being sent back to the application for the user. If the data is sufficient to support a "screening-oriented" finding, such as "a possible irregular heart rhythm has been detected," the application will direct them to a cardiologist who can provide more diagnostic services, such as... The service supports clinical diagnosis and treatment. In a further embodiment, as described elsewhere in the specification, the system can trigger an alarm if a specific measurement and / or analysis indicates that an alarm is required.

[0194] Further examples of other scenarios with clinical value could include combining ambulatory arrhythmia monitoring with a blood alcohol monitor to study the interaction between atrial apnea (AF) and lifestyle factors. For example, ambulatory arrhythmia monitoring could be combined with a blood glucose monitor to study the effects of hypoglycemia on arrhythmias. Optionally, ambulatory arrhythmia monitoring could be combined with a respiratory rate and / or volume monitor to study the interaction between sleep apnea and respiratory disorders. Furthermore, a high incidence of supraventricular ectopic beats (SVEs) could be assessed as a potential precursor to AF (e.g., 720 SVEs within 24 hours).

[0195] Extraction, transmission and processing systems

[0196] Figure 19 It's similar to the above about Figure 19 This is a schematic diagram of an embodiment of a system and method 1000 with a wearable medical sensor 1002 having transmission capabilities, described in the system and / or method. In some embodiments, the sensor 1002 can be any type of sensor or monitor described in this text or elsewhere in the specification, continuously sensing and recording ECG or similar biosignals 1004. In some embodiments, the sensing and / or recording steps can be performed intermittently. The collected signal 1004 can then be continuously extracted into one or more features 1006, representing example features A, B, and C. These features are not intended to be samples of different time segments of the signal; rather (as will be described in more detail below), different features may correspond to different types or segments of data, such as R-peak position or R-peak amplitude. Features of the ECG or similar biosignals are extracted to facilitate remote analysis of the signal 1004. In some embodiments, features are extracted based on a window, the window size of which varies, for example, from one hour or several hours to several seconds. In some embodiments, the window can be at most: about 0.1 seconds, about 1 second, about 2 seconds, about 3 seconds, about 5 seconds, about 10 seconds, about 30 seconds, about 1 minute, about 5 minutes, about 30 minutes, about 1 hour, about 2 hours, about 4 hours, or more than 4 hours. If the extraction window is repeated, the extraction window can be separated by different amounts of time. For example, the extraction window can be separated by at least the following time intervals: about 30 seconds, about 1 minute, about 5 minutes, about 30 minutes, about 1 hour, about 3 hours, about 6 hours, about 12 hours, about 24 hours, about 48 hours, or more than three days. In some embodiments, the window size can vary depending on the features being extracted. Feature extraction can be limited to one or more types of features, and the features selected for extraction may vary depending on the nature of the observed signal.

[0197] Many different types of ECG or similar biosignal features can be extracted. For example, the R-peak position can be extracted. In some embodiments, the R-peak position is extracted via various methods, such as the Pan-Tompkins algorithm (Pan and Tompkins, 1985) which provides a real-time QRS composite detection algorithm employing a series of digital filtering steps and adaptive thresholds, or an analog R-peak detection circuit comprising an R-peak detector consisting of a bandpass filter, comparator circuitry, and dynamic gain adjustment for locating the R-peak. The RR interval can be calculated based on the peak position and used as a primary feature for rhythm discrimination. In embodiments, an R-peak overflow flag can be extracted. If more than a certain number of R-peaks are detected within a given time window, making it impossible to transmit all data, the firmware may trigger a flag. Based on the physiological impossibility of extremely short RR intervals, this extraction can be used to eliminate noise segments from the analysis. For similar motivation, an R-peak underflow flag can be extracted to indicate unrealistically long intervals between consecutive R-peaks, provided that cardiac arrest is properly considered in this evaluation. In an alternative implementation with the same objective, the absence of an R-peak in the extended interval may be associated with a confidence measure that describes the likelihood that the interval is clinical or an artifact.

[0198] Generally, as used herein, the term "module" refers to a logic circuit implemented in hardware or firmware, or a collection of software instructions written in programming languages ​​such as Python, Java, Lua, C, and / or C++, which may have entry and exit points. Software modules can be compiled and linked to an executable program installed in a dynamic link library, or can be written in an interpreted programming language such as BASIC, Perl, or Python. It should be understood that software modules can be called from other modules or from themselves, and / or can be called in response to detected events or interrupts. Software modules configured for execution on a computing device can be located on computer-readable media, such as optical discs, digital video discs, flash drives, or any other tangible media. Such software code can be stored, in part or in whole, on a memory device of a computing device, such as a computing system 13000, for execution by the computing device. Software instructions can be embedded in firmware, such as EPROM. It will be further understood that hardware modules can consist of connected logic units such as gates and flip-flops and / or can consist of programmable units such as programmable gate arrays or processors. The block diagrams disclosed herein can be implemented as modules. The modules described in this article can be implemented as software modules, but can also be represented as hardware or firmware. Generally, the modules described in this article refer to logical modules that can be combined with other modules or divided into submodules, regardless of their physical organization or storage.

[0199] Each of the processes, methods, and algorithms described in the foregoing sections can be embodied in a code module executed by one or more computer systems or computer processors, including computer hardware, and can be fully or partially automated by the code module. The code module can be stored on any type of non-transitory computer-readable medium or computer storage device, such as hard disk drives, solid-state drives, optical disks, etc. The systems and modules can also be transmitted as generated data signals (e.g., as part of a carrier wave or other analog or digital propagation signal) on various computer-readable transmission media, including wireless and wired / cable-based media, and can take many forms (e.g., as part of a single or multiplexed analog signal, or as multiple discrete digital packets or frames). These processes and algorithms can be implemented, partially or entirely, in dedicated circuitry. The results of the disclosed processes and process steps can be persistently or temporarily stored in any type of non-transitory computer storage device, such as volatile or non-volatile storage devices.

[0200] The various features and processes described above can be used independently of each other or combined in various ways. All possible combinations and sub-combinations are intended to fall within the scope of this disclosure. Additionally, certain method or process blocks may be omitted in some embodiments. The methods and processes described herein are not limited to any particular order and can be executed in other suitable orders with respect to their associated blocks or states. For example, described blocks or states may be executed in a different order than specifically disclosed, or multiple blocks or states may be combined into a single block or state. Example blocks or states may be executed serially, in parallel, or in some other manner. Blocks or states may be added to or removed from the disclosed example embodiments. The example systems and components described herein may be configured differently from the described example systems and components. For example, elements may be added, removed, or rearranged compared to the disclosed example embodiments.

[0201] Unless otherwise specifically stated or interpreted in the context in which they are used, descriptive terms such as “can,” “able,” “may,” or “may” are generally intended to convey that certain embodiments include certain features, elements, and / or steps that are not included in other embodiments. Therefore, such descriptive terms are generally not intended to imply features, elements, and / or steps that are required by any means in one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without user input or prompting, whether such features, elements, or steps are included or will be performed in any particular embodiment. The term “comprising” means “including, but not limited to.” The term “or” means “and / or.”

[0202] Any process descriptions, elements, or blocks depicted in the flowcharts or block diagrams described herein and / or in the accompanying drawings should be understood as potentially representing modules, segments, or portions of code comprising one or more executable instructions for implementing a particular logical function or step in a process. As those skilled in the art will understand, alternative implementations are included within the scope of the embodiments described herein, wherein elements or functions may be omitted, or performed in a different order than shown or discussed, including substantially simultaneously or in reverse order, depending on the functionality involved.

[0203] All of the methods and processes described above can be embodied, at least in part, in software code modules executed by one or more computers, and can be partially or fully automated via these software code modules. For example, the methods described herein can be executed by a computing system and / or any other suitable computing device. These methods can be executed on a computing device in response to the execution of software instructions or other executable code read from a tangible computer-readable medium. A tangible computer-readable medium is a data storage device that can store data readable by a computer system. Examples of computer-readable media include read-only memory, random access memory, other volatile or non-volatile memory devices, CD-ROMs, magnetic tapes, flash drives, and optical data storage devices.

[0204] It should be emphasized that many changes and modifications can be made to the above embodiments, and their elements should be understood as existing in other acceptable examples. All such modifications and changes are intended to be included within the scope of this disclosure. The foregoing description details certain embodiments. However, it will be appreciated that the systems and methods can be implemented in various ways, regardless of how detailed the foregoing is in the text. For example, a feature of one embodiment may be used in conjunction with features from different embodiments. Also as noted above, the use of particular terms in describing certain features or aspects of the systems and methods should not be construed as implying that the terms are redefined herein as limited to any particular feature of the system and method that includes the feature or aspect of the system and method associated with that term.

[0205] This document discloses various embodiments of physiological monitoring devices, methods, and systems. These various embodiments can be used individually or in combination without departing from the scope of the invention, and various changes can be made to the various features of the embodiments. For example, the order of various method steps can be changed in some cases, and / or one or more optional features can be added to or removed from the described device. Therefore, the description of the embodiments provided above should not be construed as unduly limiting the scope of the invention as set forth in the claims.

[0206] Various modifications can be made to the embodiments described in this disclosure, and the general principles defined herein can be applied to other embodiments without departing from the spirit or scope of this disclosure. Therefore, the scope of this disclosure is not intended to be limited to the embodiments shown herein, but is consistent with the widest scope consistent with this disclosure, the principles disclosed herein, and the novel features.

[0207] In the context of different embodiments, certain features described herein may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented separately in multiple embodiments or in any suitable sub-combination. Furthermore, although the features above may be described as functioning in certain combinations, or even initially claimed to be so, one or more features from the claimed combinations may be removed from the combinations in certain circumstances, so that the claimed combinations may refer to sub-combinations or variations thereof.

[0208] Similarly, although operations are depicted in the accompanying drawings in a specific order, it is not necessary to perform these operations in the specific order or sequential sequence shown, or to perform all of the shown operations, to obtain the desired result. Furthermore, the drawings may schematically depict one or more example processes in the form of flowcharts. However, other operations not depicted are based on those incorporated into the schematically shown example processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the shown operations. Moreover, the separation of various system components in the above embodiments should not be construed as requiring such separation in all embodiments. Furthermore, other embodiments are also within the scope of the appended claims. In some cases, the actions recited in the claims may be performed in a different order, but the desired result may still be achieved.

Claims

1. An electronic device for monitoring a user's physiological signals, the device comprising: A housing that surrounds a hardware processor, the housing further comprising a rigid shell surrounding a flexible frame and forming at least a portion of the outer periphery of the housing, wherein a button is formed within an opening in the flexible frame, the button being configured to be manually pressed into the flexible frame by the user; as well as Electrodes are configured to detect the user's physiological signals when the electrodes are engaged with the user's surface.

2. The electronic device of claim 1, further comprising a flexible wing extending from the housing.

3. The electronic device of claim 2, further comprising a trace layer coupled to the flexible wing and configured to transmit electrical signals from the electrode to the hardware processor, the trace layer comprising a polymer body extending from a first contact region adjacent to the electrode to a second contact region adjacent to the hardware processor.

4. The electronic device of claim 3, wherein the trace layer comprises a conductive material disposed on a first side of the polymer body and a resistor disposed on the first side of the polymer body where the conductive material intersects with the first contact region and the second contact region, the conductive material having a first conductivity and the resistor having a second conductivity.

5. The electronic device of claim 4, wherein the first conductivity is greater than the second conductivity, such that the resistor applies resistance between the first contact region and the second contact region.

6. The electronic device of claim 4, wherein the trace layer includes one or more vias extending through the polymer body and filled with a conductive material, the one or more vias being electrically connected to the conductive material disposed on a first side of the polymer body and a conductive material disposed on a second side of the polymer body opposite to the first side.

7. The electronic device of claim 6, wherein the through-hole is located at the second contact area.

8. The electronic device of claim 4, wherein the first contact area includes a pore extending through the center of the first contact area to allow moisture to evaporate from the hydrogel through a flexible wing.

9. The electronic device of claim 4, wherein the first contact area is located above the electrode.

10. The electronic device of claim 4, wherein the first contact region includes a hole surrounding the electrode such that the electrode is concentrically arranged within the hole, the electrode being configured to be electrically connected to the periphery of the hole.

11. The electronic device of claim 4, wherein the first contact area is located on the bottom side of the trace layer and the second contact area is located on the top side of the trace layer.

12. An electronic device for monitoring a user's physiological signals, the device comprising: Housing, the housing comprising: A rigid shell, forming at least a portion of the outer periphery of the shell. A flexible frame, at least partially surrounded by the rigid shell, and A button, formed within an opening in the flexible frame, is configured to be manually pressed into the flexible frame by the user; and Electrodes are configured to detect the user's physiological signals when the electrodes are engaged with the user's surface.

13. The electronic device of claim 12, wherein the device comprises: An adhesive layer is attached to the bottom surface of the flexible wing of the electronic device to adhere the electronic device to the user. The flexible wing and / or the adhesive layer include a therapeutic agent for delivery to the user's surface, and the adhesive layer is configured to allow the therapeutic agent to be eluted to the user's surface through the adhesive layer.

14. The electronic device of claim 13, wherein the adhesive layer comprises a hydrocolloid.

15. The electronic device of claim 13, wherein the therapeutic agent is configured to reduce skin flushing, reduce itching, reduce bacterial growth, induce histamine release, and / or provide an anesthetic effect.

16. The electronic device according to any one of claims 13 to 15, wherein the therapeutic agent is dissolved in the adhesive layer.

17. The electronic device according to any one of claims 13 to 15, wherein the therapeutic agent is contained within a plurality of pouches disposed within one or more base layers of the flexible wing.

18. The electronic device of claim 17, wherein one or more base layers of the flexible wing include pores configured to facilitate delivery of the therapeutic agent through the flexible wing.

19. The electronic device according to any one of claims 13 to 15, wherein the adhesive layer includes one or more pores configured to facilitate delivery of the therapeutic agent through the adhesive layer to the user's surface.

20. An electronic device for monitoring a user's physiological signals, the device comprising: Housing, the housing comprising: A rigid shell, forming at least a portion of the outer periphery of the shell. A flexible frame is arranged within the central opening of the rigid shell, and A button, disposed on the top surface of the flexible frame, is configured to be manually pressed into the flexible frame by the user; and The sensor is configured to detect the user's physiological signals when the sensor is engaged with the user's surface.

21. The electronic device of claim 20, wherein the flexible frame is overmolded onto the rigid shell.

22. The electronic device according to any one of claims 20 to 21, wherein the button is a rigid element and the flexible frame connects the button to the rigid housing, the flexible frame forming a flexible boundary around the button such that the button is a floating button and pressing the button causes the flexible frame to bend.

23. The electronic device of any of claims 20-21, wherein the housing further comprises: The top housing connects to the bottom housing; A column extends downward from the top housing; And a rod extending upward from the bottom housing, the rod being housed in the column or the column being housed in the rod, wherein the column and the rod are press-fitted together and configured to resist internal forces within the housing that would facilitate separation of the top housing from the bottom housing.

24. The electronic device of claim 23, further comprising: A spring, located between the bottom surface of the bottom housing and the hardware processor of the electronic device, is configured to include a tolerance superposition within the housing.

25. The electronic device of claim 24, wherein the housing surrounds the battery, and the spring is further configured to bias traces electrically connected to the battery terminals and traces electrically connected to the sensor into electrical contact with the hardware processor.

26. The electronic device of claim 25, wherein the electrical contact is achieved via a plurality of spring contacts.

27. The electronic device of claim 24, wherein the spring is a wave spring.

28. The electronic device of claim 24, further comprising a spacer located between the hardware processor and the battery, the spacer being configured to hold the battery at a constant interval distance from the hardware processor.

29. The electronic device of claim 24, further comprising a foam located between the bottom surface of the housing and the hardware processor, the foam being configured to include a tolerance stack within the housing.

30. The electronic device of claim 24, wherein the hardware processor includes a trigger input configured to be manually activated by a user to indicate a trigger event, the opening being located above the trigger input, and the button being configured to be manually pressed to activate the trigger input.

Images