Adhesive physiological monitoring device

Abstract

This disclosure relates to cardiac monitoring devices, systems, and / or methods of using such systems. Preferred embodiments may include an adhesive layer having channels for moisture evaporation to facilitate long-term adhesion of the device to a subject. The adhesive layer may be surrounded by a non-adhesive liner to prevent the base layer from folding beneath the adhesive. In some embodiments, the adhesive layer may be replaceable. In some embodiments, the adhesive layer may extend beneath a base attached to a housing but not adhere to the base layer above it. The angle of the edges of the adhesive layer may be configured to minimize peel forces. The base layer above the adhesive layer may be perforated to facilitate moisture evaporation and / or provide adhesion to the base layer. Perforation may enhance anisotropic resistance to compression and / or elongation of the base layer.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 062,293, filed on August 6, 2020, which is incorporated herein by reference in its entirety. Background of the Invention

[0003] 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 more 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

[0007] 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

[0008] 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.

[0009] 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 a mammalian surface 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 mammalian movement; at least two electrodes embedded within the flexible wings, the electrodes being configured to provide conformal contact with the mammalian surface 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 mammalian surface 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.

[0010] 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.

[0011] In some embodiments, motion signals can be collected in real time along with physiological signals. In certain 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 by a housing to prevent mechanical stress on the printed circuit board when the trigger is activated, which in turn reduces artifact sources in the recorded signal. The event trigger can be concave or convex and larger than a human finger for easy positioning. In some embodiments, electrode traces are configured to minimize signal distortion during mammalian movement. In certain embodiments, a gasket can be used as a tool for hermetically attaching to the 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 sensors containing a QRS detector that generates real-time estimates of the location of each R peak in an ECG.

[0019] b. According to a predetermined schedule, transmit the RR interval time series along with the start timestamp from the sensor to a smartphone or internet-connected gateway device.

[0020] c. Transmit the RR interval time series and start timestamp from a smartphone or internet-connected gateway device to the server.

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

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

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

[0024] g. Transmit the start / end time of each remaining heart rhythm after filtering from a smartphone or internet-connected gateway device to a wearable sensor.

[0025] h. Transmit the recorded ECG portions corresponding to each start and end time pair from the sensor to a smartphone or internet-connected gateway device.

[0026] i. Transmit the recorded ECG portions corresponding to each start and end time pair 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] a. 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] b. Estimate the confidence statistic for each heart rhythm type based on the inferred frequency and duration of the central rhythm from the RR interval time series set for a given user.

[0032] c. Assess whether the confidence statistic for each inferred heart rate exceeds a predetermined threshold.

[0033] d. Provide heart rhythm information 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] e. Time-series data of user activity measured by accelerometers

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

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

[0038] h. 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] i. A confidence level provided by the measuring device to indicate, for example, the quality of heartbeat estimates for each heartbeat or a continuous period of time.

[0040] j. 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 during each surrounding 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 the 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; and

[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] Figures 4A to 4E Examples of adhesive layers including different channel arrangements are schematically depicted. Figure 4A A top view schematically showing a portion of the adhesive layer including vertical channels. Figure 4B An adhesive layer including column channels is schematically shown. Figure 4C and Figure 4D An example of an adhesion layer containing a channel lattice network is shown schematically. Figure 4E An adhesive layer comprising radially spiral channels is schematically shown.

[0066] Figures 5A to 5H Another embodiment of the physiological monitoring device is illustrated schematically. Figure 5AA schematic bottom view of the physiological monitoring device, showing the horizontal arrangement of its various constituent layers. Figure 5B The supporting layer of the main structure forming the flexible body is shown. Figure 5C Show Figure 5B A close-up of illustration A depicted in the text. Figure 5D The central portion of the support layer on the subject's skin is shown, constructed to float between the hinge lines of a flexible body. Figure 5E The illustration shows a perforated layer (e.g., a perforated PET layer) that includes pores for providing structural support to the wing while allowing moisture transport, according to some embodiments. Figure 5F Show Figure 5E A close-up view of illustration A depicted in the text. Figure 5G Two adhesion layers are depicted. Figure 5H A three-dimensional diagram of the physiological monitoring device was depicted.

[0067] Figures 6A to 6H Various views illustrating embodiments of the physiological monitoring device are shown. Figure 6A A three-dimensional drawing was depicted. Figure 6B A top view is depicted. Figure 6C A bottom view was depicted and Figure 6D1 A side view is depicted. Figure 6D2 A side view depicts the ridges at the top and bottom of the enclosure that are constructed to seal the housing. Figure 6E and Figure 6F The diagram shows bottom and top views of the physiological monitoring device, with layers shown transparently to provide visualization through the device. Figure 6G and Figure 6H An exploded view of the various components of the physiological monitoring device is shown.

[0068] Figures 7A to 7F The outline of the base layer of a flexible body with hinge lines is schematically shown. The flexible body is configured to float between the hinge lines. Figures 7B to 7D Various examples of constructions including adhesive layers designed to connect to a flexible body and extend beneath the shell are schematically shown. Figure 7E A bottom view schematically illustrates a physiological monitoring device comprising a single adhesive layer having a “headphone-like” construction and including a bridging portion. Figure 7F An embodiment of the airfoil is depicted.

[0069] Figures 8A to 8J An embodiment of a physiological monitoring device having a rigid body and traces connected to the top surface of a flexible body is schematically shown. Figures 8A to 8J The steps involved in assembling and / or replacing a physiological monitoring device, including a flexible body with an adhesive layer, are illustrated.

[0070] Figure 9 This is a top and bottom view of the housing of a physiological monitoring device according to one embodiment.

[0071] Figure 10A and Figure 10B A perspective view of a battery holder for a physiological monitoring device according to one embodiment is provided.

[0072] Figure 11A and Figure 11B This is a cross-sectional view of a physiological monitoring device according to one embodiment.

[0073] Figure 12 This is an exploded view of a physiological monitoring device including multiple optional items according to one embodiment.

[0074] Figure 13A and Figure 13B 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.

[0075] Figure 14A , Figure 14B , Figure 14C , Figure 14D , Figure 14E and Figure 14F The illustration shows the various steps for applying a physiological monitor to a patient's body according to one embodiment.

[0076] Figure 15 A schematic diagram illustrating an embodiment of the heart rhythm inference service. Detailed Implementation

[0077] 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 one 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. Many other alternative embodiments and applications of the described technology are possible. Therefore, the following description is provided for illustrative purposes only. Throughout the specification, the term “conformal” may be referenced. Those skilled in the art will understand 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.

[0078] 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 infrequently 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. 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 device use, and the possibility of capturing all important information. Lack of adherence and the limitations of the device often result in the need for additional devices, follow-up monitoring, or other tests to make a correct diagnosis.

[0079] Current methods for linking symptoms to 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., in their 1980 publication, "Assessment of the Diagnostic Value of 24-Hour Ambulatory Electrocardiographic Monitoring," Volume 7 of Biotelemetry Patient Monitoring).

[0080] 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), not 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 a potential delay in diagnosis and increase the likelihood of arrhythmias going 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.

[0081] To address some of these problems in cardiac monitoring, the assignee of this application has developed various embodiments of a small, long-term, wearable, physiological monitoring device. One embodiment of this device is the Zio® patch. Various embodiments are also described, for example, in patents Nos. 8,150,502, 8,160,682, 8,244,335, 8,560,046, 8,538,503, 9,173,670, and 9,597,004, and U.S. Patent Application Publication No. 2018 / 0289274 A1, 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 heart rhythm signal data while the device is worn, and this heart rhythm data can then be processed and analyzed.

[0082] These smaller, long-duration, patch-based physiological monitoring devices offer many advantages over existing technologies. However, further improvements are still 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.

[0083] 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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 the increased risk of stroke associated with this arrhythmia, such as advanced age, pre-existing chronic conditions like heart disease, or even previous surgery. 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.

[0088] 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.

[0089] 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.

[0090] 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.

[0091] Physiological monitoring device

[0092] 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. The electrodes are configured to sense heart rhythm signals from a patient to whom the monitoring device 100 is attached. The 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.

[0093] 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 (See image) Peeled or lifted off the skin, 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.

[0094] 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). During assembly, gaskets 370 and 360 help to waterproof the housing 115. Multiple components of the monitoring device 100 can 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 a 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.

[0095] 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 lugs 153 for accommodating the battery 160 within the battery holder 150. Furthermore, the battery holder 150 includes a plurality of legs 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. Eliminating soldered connections also simplifies and speeds up the assembly and disassembly of the monitoring device 100.

[0096] 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.

[0097] However, in Figure 1A and Figure 1B In the illustrated embodiment, the housing 115 is sufficiently rigid, while the flexible body 110 is sufficiently flexible 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.

[0098] 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 housing 115, it is beneficial for the PCBA 120 to have sufficient rigidity to prevent undesired 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 housing 115 during patient trigger activation. In some embodiments, one way to ensure PCBA rigidity is to ensure that the PCBA thickness 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.

[0099] 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 responsive to pressure from the patient trigger (e.g., the upper surface of the upper housing member 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 standalone device or as a smartphone application.

[0100] 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.

[0101] 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 changes 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.

[0102] 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.

[0103] In addition to detecting motion artifacts, accelerometers tuned to the dynamic range of human body activity can provide the patient's activity level during recording, which can also 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 simultaneously with an increase in heart rate, it can be more confidently distinguished from non-pathological sinus tachycardia. More broadly, providing activity information to clinical professionals may 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 may help to more specifically determine the type of activity, such as walking or running. This additional information may help to interpret symptoms more specifically, thus influencing subsequent treatment.

[0104] 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 PCBA 120, 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 present 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 an upright to a relaxed position. 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.

[0105] 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 in a relatively still state, allowing subtle signal modulation introduced by chest movements due to breathing to be observed. Respiratory rate information is useful as an information channel required for detecting sleep apnea in certain patient populations.

[0106] 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 through the number of consecutive taps.

[0107] 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.

[0108] 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.

[0109] 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.

[0110] 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.

[0111] 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.

[0112] 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.

[0113] In addition to the choice of materials, the dimensions of the substrate layers 300 and 330—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 the other 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.

[0114] As described above, the hinge 132 allows the rigid housing 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 housing 115 to be lifted sufficiently without exerting excessive peeling forces 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.

[0115] 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 the coverage area 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 flexible body 110 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 flexible body 110. In some embodiments, the boundary 133 may include a width of at least about 3 mm, 6 mm, 9 mm, 12 mm, or 15 mm (e.g., from the outer edge of the boundary 133 to the inner edge of the boundary 133). In an alternative embodiment, the coverage areas of the base layers 300 and 330 can be the same, so there is no boundary 133.

[0116] 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 beneficial for adhesion, patient comfort, and the accuracy of the collected cardiac rhythm data, but alternative configurations may be implemented in alternative embodiments.

[0117] 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 an aqueous colloidal adhesive. In another embodiment, the adhesive layer 340 is composed of an aqueous colloidal adhesive containing naturally derived or synthetic absorbent materials that absorb moisture from the skin during perspiration.

[0118] 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 adhesion to the flexible body 110. In one embodiment, for example, the flexible electrode 350 may be made of hydrogel. 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 through the hydrogel electrodes 350. In an alternative embodiment, the electrodes 350 and adhesive 340 may be replaced by 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 aqueous colloidal adhesive. Figure 1A The housing 115 also protects the electronics and power supply contained in the housing and / or PCBA 120, 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.

[0119] 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, the hinge 132 may be formed in the flexible body 110 as a portion of each wing 130, 131 without the applied adhesive layer 340. The 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 the 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. The 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.

[0120] 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 amplification device 101 is assembled. The electrode interface 310 contacts the hydrogel electrode 350. Therefore, electrode traces 311, 312 transmit heart rhythm signals (and / or other physiological data in various embodiments) from the electrode 350 to the PCBA 120.

[0121] 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.

[0122] 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.

[0123] 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 member 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.

[0124] Figures 4A to 4E Embodiments of adhesive layer 340 are depicted, which can be included as an adhesive layer in the embodiments of Figures 1 to 3 and below. Figures 5A to 8D This adhesive layer can be incorporated into any of the physiological monitoring device embodiments described in this section or elsewhere in the specification. In some embodiments, the adhesive layer 340 can be configured to optimize (e.g., maximize) the flow of moisture from, for example, through the wings of the device, such as 130, 131 described above. Figure 1A To Figure B, Figures 3A to 3E and Figures 5A to 8D The physiological monitoring device depicts evaporation from the patient's skin surface beneath it. The physiological monitoring device 100 promotes water evaporation (e.g., ...). Figure 3E (As shown elsewhere) the adhesion of device 100 to the patient's skin can be improved by preventing, reducing, and / or inhibiting the accumulation or pooling of moisture between the patient's skin and the bottom of adhesive layer 340. Moisture accumulation between the patient's skin and the bottom of adhesive layer 340 can prevent, inhibit, and / or interfere with the adhesion of adhesive layer 340 to the patient's skin, especially over extended periods. For example, the presence of excessive moisture can cause, promote, and / or accelerate the peeling of the edges of adhesive layer 340 from the patient's skin. Therefore, long-term adhesion can be achieved by promoting the evaporation of moisture through the device so that the moisture can be released (e.g., evaporate) into the atmosphere. Moisture management may be particularly beneficial when the patient sweats, such as during exercise or during a hot shower.

[0125] In a particular embodiment, the adhesive layer 340 may typically include an adhesive layer 330 (such as...) Figure 3B The adhesive layer 340 has a bottom surface (as shown elsewhere) or a top surface of another support layer and a bottom surface configured to adhere to the patient's skin. The top surface may typically overlap the bottom surface, and / or the top and bottom surfaces of the adhesive layer 340 may define an adhesion region or surface region extending horizontally to the peripheral edge of the adhesive layer 340. The adhesive layer 340 may have a vertical thickness extending from the bottom surface to the top surface. The thickness of the adhesion region may be relatively uniform. In some embodiments, the adhesive layer 340 may include a plurality of channels 341 connecting the bottom surface of the adhesive layer 340 to the top surface and / or peripheral edge of the adhesive layer 340. The channels 341 may be formed as voids within the adhesive layer 340. In some embodiments, the cumulative surface area of ​​the channels 341 at the junction of the channels 341 and the subject's skin may be proportional to the rate of moisture evaporation. A larger cumulative surface area of ​​the void region may increase the evaporation rate but may reduce the adhesion between the subject's skin and the adhesive layer 340. The adhesive layer 340 may or may not include a barrier separating the void body from the adhesive matrix material (e.g., an aqueous colloid).

[0126] In some embodiments, including channels 341 within the adhesive layer 340 generally allows the adhesive layer 340 to adhere more closely to the surface of the subject (e.g., skin). For example, due to the presence of multiple channels 341, the adhesive layer 340 can better absorb bending strain, which can promote or improve adhesion between the physiological monitoring device (such as those described in this section or throughout the specification) and the test site, particularly on uneven surfaces and / or parts of the body expected to undergo dynamic conformational changes. The multiple channels 341 can be arranged to facilitate the flexible body 110 (e.g., ...) in response to specific muscle extension and / or contraction. Figure 3B Custom motion or strain (as shown elsewhere).

[0127] Figures 4A to 4E An example of an adhesive layer 340 comprising different arrangements of channels 341 is further illustrated. The multiple channels 341 can typically be linear and / or non-linear. In some embodiments, the multiple channels 341 may include vertical channels 341 extending from the top surface to the bottom surface of the adhesive layer 340. Figure 4A A schematic top view of a portion of an adhesive layer including a vertical channel 341 is shown. The vertical channel 341 may extend in a direction substantially perpendicular to the top and / or bottom surfaces of the adhesive layer 340. The cross-section of the vertical channel 341 may typically be as follows: Figure 4A The shapes shown can be rhomboid, circular (e.g., cylindrical channels), elliptical, rectangular, trapezoidal, pentagonal, hexagonal, other polygonal, or any other suitable shape. In some embodiments, particularly in those where the vertical channels 341 are closely spaced, the remaining adhesive layer 340 may take the form of a mesh structure, such as... Figure 4A As shown. The shape of the vertical channels 341 can affect the mechanical properties of the lattice adhesion layer 340. Diamond-shaped channels 341 can allow preferential expansion and / or compression in an accordion-like manner. For example, Figure 4A The adhesive layer 340 shown can provide less tensile and / or compressive resistance along an axis parallel to the angles bisecting the rhomboid vertical channel 341 than along an axis parallel to the grid-like struts formed by the adhesive layer 340. Furthermore, the adhesive layer 340 can provide less tensile and / or compressive resistance along an axis parallel to the larger angles bisecting the vertical channel 341 than along an axis parallel to the smaller angles bisecting the vertical channel 341.

[0128] In some embodiments, the plurality of channels 341 may include horizontal rows or columns of channels 341 connecting the top and bottom surfaces of the adhesive layer 340. The rows or columns may be arranged at relatively uniform intervals. The rows or columns may extend from and / or reach the periphery of the adhesive layer 340. The rows or columns may extend across the adhesive layer to another point on the periphery of the adhesive layer 340 that divides the adhesive layer into strips 342. Figure 4BAn adhesive layer 340 including column channels 341 is schematically shown. In some embodiments, the adhesive layer 340 including rows or columns of channels 341 may be configured to face the subject such that the rows or columns extend parallel to the subject's height (e.g., aligned with the direction from the subject's head to the subject's feet). When the subject (e.g., a human subject) is in an upright (e.g., standing) position, aligning the channels 341 fully or partially with the subject's height can advantageously facilitate the drainage of water under gravity from beneath the adhesive layer 340. The orientation of the channels 341 may be defined by an orthogonal component, and the effect of gravity may depend on the magnitude of the component aligned with height. Aligning the channels 341 along a first direction (e.g., aligned with the subject's height) can partially mitigate tensile and / or compressive forces along a second direction orthogonal to the first direction (e.g., laterally aligned with the subject's height). In some embodiments, the channels 341 may be arranged such that the channels 341 are laterally aligned with the direction expected to experience the most significant strain (e.g., the channels 341 may be laterally aligned with the direction of muscle extension / contraction, on which the physiological monitoring device 100 is located). Channel 341 can absorb some pressure, thereby increasing the lifespan of the adhesion layer 340. The presence of channel 341, and especially the arrangement of channel 341, can mechanically increase the resistance of the adhesion layer 340 to delamination from the subject's skin, particularly along certain directions, and can facilitate the physiological monitoring device 100 (such as... Figure 3E (As shown elsewhere) Long-term adhesion.

[0129] In some embodiments, the plurality of channels 341 may include rows and columns. The rows and columns may be arranged at uniform intervals (e.g., substantially perpendicular to each other) to form a grid that divides the adhesive layer 340 into islands 343 of adhesive material. The islands 343 may have a rectangular configuration (e.g., a vertical grid), a rhomboid configuration, a trapezoidal configuration, a pentagonal configuration, a hexagonal configuration, other polygonal configurations, etc. Figure 4C and Figure 4DAn example of an adhesive layer 340 comprising a grid of channels 341 is schematically shown. In various embodiments, a maximum separation distance 344 may exist between the channels 341. In other words, each channel 341 may be spaced apart from another channel 341 or from the outer edge of the adhesive layer 340 at any point along the length of the channel 341 by no more than the maximum separation distance 344. In some embodiments, the maximum separation distance 344 may be approximately 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 20 mm, 25 mm, 30 mm, or greater than 30 mm. The actual separation distance may be equal to the maximum separation distance 344. In some preferred embodiments, the separation distance may be approximately 8 mm. The close spacing of the channels 341 (e.g., within the maximum separation distance 344) may more effectively promote the evaporation of moisture from beneath the adhesive layer 340 and / or may prevent, reduce, or minimize the amount of peeling of the adhesive layer 340 from the subject's skin.

[0130] In some embodiments, the strips 342 and / or islands 343 of the adhesive material may be interconnected by a network of thin strips 345. The strips 345 may comprise thin, flexible strands of material that bind the strips 342 and / or islands 343 together. In some embodiments, the strips 345 may comprise nylon, cotton, polyester, and / or another suitable material. In some embodiments, the strips 345 may extend through the strips 342 and / or islands 343, such as... Figure 4B As illustrated schematically. For example, in some embodiments, strips 342 and / or islands 343 may be formed around the strands constituted by the strips 345, such that the strands extend through the internal volume of the strips 342 and / or islands 343. In some embodiments, the network constituted by the strips 345 may include a network of generally perpendicular rows and columns of strands, such as... Figure 4C and Figure 4D As shown. In some embodiments, the network formed by the strips 345 can be used in conjunction with, for example... Figure 4C The rows and columns of the channel 341 shown are oriented in substantially the same manner, with the rows of strands distributed in the rows of channel 341 and the columns of strands distributed in the columns of channel 341. In some embodiments, the network formed by the strips 345 may be oriented in a manner similar to that shown. Figure 4D The difference is shown in that the rows and columns of the strip 345 are offset from the rows and columns of the channel 341 by approximately 45 degrees. The strip 345 can extend diagonally through the island 343 and the strips formed by the strip 345 can intersect each other within the channel 341.

[0131] In some embodiments, channels 341 may be arranged in a radial pattern (e.g., a linear spoke pattern). In some embodiments, channels 341 may be non-linear (e.g., a coaxial arrangement of annular channels 341). For example, as Figure 4E As schematically shown, channels 341 can be arranged radially in a helical manner in a horizontal plane. Channels 341 may meet at a center point 346. In some embodiments, the center point 346 may be a solid sheet of the adhesive layer 340. In some embodiments, the center point 346 may be a void space, such as... Figure 4E As shown. The void space can be substantially circular. In some embodiments, the void space may include at least about 5%, 10%, 15%, 20%, 25%, or 30% of the total surface area of ​​the adhesive layer 340.

[0132] In some embodiments, strips 342 and / or islands 343 of adhesive material may be attached to a thin backing layer. For example, in some embodiments, strips 342 and / or islands 343 may be formed directly on the bottom surface of the bottom substrate layer 330. In some embodiments, the adhesive layer 340 may be formed on a removable backing layer that is removed from the adhesive layer 340 after it has been transferred to the bottom substrate layer 330 of the flexible body 110. In some embodiments, the adhesive layer 340 may be formed without any backing layer (e.g., formed around strips 345). In some embodiments, channels 341 may be formed during the manufacture of the adhesive layer 340. For example, the adhesive matrix of the adhesive layer 340 may be formed around a mold that shapes the channels 341. In some embodiments, channels 341 may be formed after the manufacture of the adhesive layer 340. For example, the adhesive layer 340 may be perforated after manufacture, or vertical channels 341 may be perforated through the adhesive layer 340. In some embodiments, conduits (e.g., capillaries) may be inserted and pass through the adhesive layer 340 to form a vertical channel 341. In some embodiments, horizontal strips of the adhesive layer may be removed (e.g., by cutting), leaving strips 342 and / or islands 343 composed of adhesive material. In some embodiments, the adhesive matrix of the adhesive layer 340 may be formed on a backing layer or substrate before adhering the adhesive layer 340 to a bottom substrate layer 330 (such as...). Figure 3BThe adhesive layer 340 can optionally be removed from the adhesive layer 340 before (as shown elsewhere). In some embodiments, the adhesive layer 340 may be fabricated around strands of a woven or nonwoven strip network 345, as described elsewhere herein. In the case where the adhesive layer is fabricated around strands of a nonwoven strip, the channels may appear as random voids dispersed by the adhesive (which may have any suitable shape, such as an ellipse). Channels are formed where voids and / or pouches are joined, but their presence can improve airflow through the adhesive even where they are not directly joined. This approach can improve skin adhesion with a less rigid adhesive layer. In some embodiments, the strip network 345 may be attached to the adhesive layer 340 after the adhesive layer has been fabricated (e.g., pressed in). The strip network 345 can be used to assist in removing the adhesive layer 340 from a mold or backing layer and / or to position the adhesive layer 340 on the bottom base layer 330 of the flexible body 110. In some embodiments, the adhesive layer 340 may include channels for evaporation. Such channels may or may not have continuous walls. In some embodiments, the channel can be vertical, orthogonal, or oriented at any suitable angle.

[0133] In some embodiments, the adhesive layer 340 may include a moisture-absorbing material (e.g., a water-absorbing material) and / or may be bonded to a layer of moisture-absorbing material. The moisture-absorbing material may include a moisture-absorbing fiber matrix. The moisture-absorbing material may include wool, nylon, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), thermoplastic elastomer (TPE), and / or any other suitable water-absorbing material. In some embodiments, the moisture-absorbing material may be hydrophobic and / or hydrophilic, such that the core can retain water, move water outward / upward, and the outer sheath of the fibers can insulate the surrounding adhesive from moisture. The moisture-absorbing material may be formed as a layer above the top surface of the adhesive layer 340 (e.g., between the adhesive layer 340 and the bottom base layer 330) or used as a capillary. The moisture-absorbing material may be used to partially or completely fill or cover one or more of the plurality of channels 341. In some embodiments, the inclusion of a moisture-absorbing material can facilitate the absorption of moisture from the subject's surface through channel 341 and / or the absorption of moisture into the adhesive layer 340 and / or the upper base layer, such as through a moisture-permeable layer. In some embodiments, moisture can be moved to the uppermost surface and optionally evaporated through the moisture-permeable layer, and / or moved to the outer edge of the adhesive for evaporation. The inclusion of a moisture-absorbing material can allow moisture storage within the adhesive layer 340 away from the interface between the bottom of the adhesive layer 340 and the subject's skin, where moisture may promote delamination of the adhesive layer 340. When moisture from the subject's surface cannot evaporate as quickly as generated by the device 100, storing moisture within the adhesive layer 340 or other layers of the physiological monitoring device 100 may be advantageous in preventing or inhibiting moisture buildup between the bottom surface of the adhesive layer 340 and the skin. In some embodiments, the wicking and / or fibers present in the material can be oriented to draw moisture radially outward from the adhesive. In the outer regions of the adhesive or where perforations are present, moisture channels can be created that maximize the surface area of ​​those fibers, thereby allowing internally accumulated moisture to evaporate.

[0134] The peripheral edges of the adhesive layer 340 can promote undesirable adhesion of material to the periphery of the adhesive layer 340. Particularly in examples including boundary 133, portions of the flexible body 110 can adhere to the peripheral edges of the adhesive layer 340. For example, the bottom surface of the top base layer 300 forming boundary 133 can adhere to the peripheral edges of the adhesive layer 340. Adhesion of the base layer of the flexible body 110 to the peripheral edges of the adhesive layer 340 may cause the flexible body 110 to deform from its intended construction and / or may interfere with the proper structure and stress distribution of the entire flexible body 110, which may reduce or decrease the duration of long-term adhesion between the device 100 and the skin. Additionally or alternatively, adjacent portions of dirt, debris, or skin may adhere to the peripheral edges of the adhesive layer 340, which may also interfere with long-term adhesion. Foreign matter adhering to the peripheral edges of the adhesive layer 340 may promote or cause loss of adhesion between the subject's skin and the bottom surface of the adhesive layer 340. Delamination of the adhesive layer 340 may tend to begin from the edges of the adhesive layer 340. If the edge begins to delaminate from the skin, boundary 133 or other material adhering to the outer edge may become entangled beneath the adhesive layer 340 between the bottom surface and the skin. For example, boundary 133 may begin to fold beneath the adhesive layer 340. The material squeezed between the bottom surface of the adhesive layer 340 and the subject's skin may stress and / or deform the adhesive layer 340, potentially leading to further delamination, thus peeling may begin primarily from the outer edge. The adhesive forces between the bottom surface of the adhesive layer 340 and the external material may continue to draw material beneath the adhesive layer 340, creating an "inchworm effect," particularly when the adhesive forces of the adhesive layer 340 on the material are stronger than those on the subject's skin.

[0135] In some embodiments, adhesion to the peripheral edges of the adhesive layer 340 can be prevented or prevented by covering the peripheral edges of the adhesive layer 340 with a non-adhesive material in the form of a barrier liner. In some examples, no adhesive may be applied to the periphery, so that a barrier liner is not needed to prevent or prevent adhesion to the peripheral edges. In the absence of an adhesive on the periphery, the adhesive may be printed onto the carrier film but not onto the periphery. In some embodiments, the non-adhesive material may include silicone resin (e.g., polydimethylsiloxane (PDMS)) and / or any other suitable material. The non-adhesive liner may outline the entire periphery of the adhesive layer 340 or may outline continuous and / or discontinuous portions of the periphery. The non-adhesive liner may include a ring-shaped (e.g., annular) arrangement. The inner diameter of the non-adhesive liner may be approximately equal to the outer diameter of the adhesive layer 340. The non-adhesive liner may generally be flexible or resilient, such that it can conform to the peripheral edges of the adhesive layer 340 and / or withstand dynamic strain during subject movement without delamination from the adhesive layer 340. The non-adhesive liner may extend from the top of the peripheral edge to the bottom of the peripheral edge or may extend along a portion of the thickness (e.g., a top portion, a bottom portion, and / or a middle portion). The non-adhesive liner may include a width extending from the peripheral edge of the adhesive layer 340 to the outer edge of the liner. The width may not exceed about 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, or 5 mm. In some embodiments, the inner diameter of the non-adhesive liner may include an adhesive surface that may facilitate adhesion of the non-adhesive liner to the peripheral edge of the adhesive layer 340. In some embodiments, the bottom surface of the non-adhesive liner may be non-adhesive, thereby forming a buffer between the bottom surface of the adhesive layer 340 and the outer diameter of the non-adhesive liner. In some embodiments, the bottom surface of the non-adhesive liner may be adhesive and configured to adhere to the subject's skin. The non-adhesive liner may prevent or inhibit any portion of the flexible body 110, any other material, or adjacent portions of the skin from adhering to the peripheral edge of the adhesive layer 340 and / or may prevent or inhibit material from intercalating between the bottom surface of the adhesive layer 340 and the subject's skin. Non-adhesive linings can promote or increase the duration of long-term adhesion of the adhesive layer 340 to the subject's skin.

[0136] In some embodiments, the peripheral region of the adhesive layer 340 may include a gradually decreasing thickness. The thickness of the adhesive layer 340 may decrease radially outward from a central location toward the peripheral edge of the adhesive layer 340, and / or vice versa. In some embodiments, the central location may be a substantially central point of the adhesive layer 340 so that the width is variable over the entire radius of the adhesive layer 340. In some embodiments, the central region of the adhesive layer 340 may include a uniform thickness and the peripheral annular region may include a gradually decreasing thickness, and / or vice versa. In some embodiments, particularly in embodiments where the adhesive layer 340 includes a substantially circular surface region, the thickness of the adhesive layer 340 may be uniform in the circumferential direction or at points equidistant from the peripheral edge. In some embodiments, at least the outermost 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm of the adhesive layer 340 may include a gradually decreasing thickness. A gentler taper may provide a more advantageous structure and distribute stress more evenly through the adhesive layer 340. The thickness of the outer edge of the adhesive layer 340 may not exceed approximately 5%, 10%, 15%, 20%, 25%, 30%, 40%, or 50% of the maximum thickness of the adhesive layer 340 (e.g., at the central portion). In some embodiments, the thickness may be gradually reduced to a generally sharp edge with negligible thickness. This reduction in thickness at the outer edge can prevent or inhibit any portion of the flexible body 110, any other material, or adjacent portions of skin from adhering to the outer edge of the adhesive layer 340 and / or can prevent or inhibit material from intercalating between the bottom surface of the adhesive layer 340 and the subject's skin. The gradually decreasing outer edge can promote or increase the duration of long-term adhesion of the adhesive layer 340 to the subject's skin.

[0137] Figures 5A to 5H schematically showing something similar to Figures 1A to 1B And later in the instruction manual, such as Figures 6A to 6H Another embodiment of the physiological monitoring device 200 is depicted in the additional figure. Figure 5AA bottom view schematically illustrates a physiological monitoring device 200 comprising a horizontally arranged array of various constituent layers. The physiological monitoring device 200 may include wings 232, 231, each asymmetrical or symmetrical about a longitudinal axis extending between electrodes 350. One of wings 231, 232 may include a body disproportionately positioned above the longitudinal axis, while the other wing 231 may include a body disproportionately positioned below the longitudinal axis. Wings 231, 232 may allow a flexible body to be asymmetrical about a transverse axis, perpendicular to the longitudinal axis, and extending through a housing 215, and also include a patient trigger 216. In some embodiments, the patient trigger may comprise 10% to 30% of the total top area, such as about 20% or about 23% of the top area, such as about 22.8% of the total top area. In some embodiments, the patient trigger may comprise more than about 20%, more than about 30%, more than about 40%, more than about 50%, or more than about 75%. In some examples, the patient trigger may comprise the entire top surface of the housing. Wings 231, 232 may include the same shape, such as... Figure 5A As shown, these shapes are inverted or flipped around the longitudinal and transverse axes. The construction of the flexible body may be particularly suitable for arranging electrodes diagonally relative to the height of the subject.

[0138] In various embodiments, such as Figures 3A to 3E , Figures 5A to 5H As shown in any other embodiments described herein, one or more of the substrate or support layers supporting the adhesion layer 340 and the electrode 350 may include perforations or holes 332 of varying thicknesses through one or more layers. The holes 332 can provide permeability through one or more layers and can facilitate the evaporation of moisture from beneath the adhesion layer 340 through one or more layers including the holes 332. The shape and / or arrangement of the holes 332 can affect the mechanical properties of the lattice adhesion layer 340. The holes 332 can provide a degree of plasticity or conformability to a relatively rigid layer that provides structural support for the flexible bodies 110, 310. For example, the holes 332 can improve the flexibility of the thin layer. In some embodiments, the holes 332 may be circular, such as… Figure 5A As shown. In some embodiments, the holes can be rhomboid, similar to the vertical channel 341 shown in FIG. 4. In embodiments, the holes 332 can be rectangular, square, elliptical, trapezoidal, pentagonal, hexagonal, polygonal, or any other suitable shape. Similar to the vertical channel 341 in the adhesive layer 340, the holes 332 can form a mesh structure in at least one region of the perforated layer, particularly where the holes 332 are close together. The perforated layer can provide anisotropic resistance to tension and / or compression along the respective axes in the horizontal plane of the perforated layer in the same manner as the vertical channel 341 described elsewhere herein.

[0139] In some embodiments, wings 130, 131 may include structural reinforcement members (not shown) along the peripheral edges of wings 130, 131. The structural support members may include a fine, linear construction. The structural reinforcement members may be disposed in or between any layers of wings 130, 131, such as the top base layer 300 or the bottom base layer 330. In some embodiments, the structural reinforcement members may be disposed outside and around the boundary 133 of the adhesive layer 340. Even if the adhesive layer 340 begins to peel, deteriorate, and / or crack along its edges, the structural reinforcement members may maintain or preserve the overall shape (e.g., outer contour) of wings 130, 131. The structural support members may include relatively rigid metals or plastics. In some embodiments, the structural support members may include shape memory materials (e.g., nitinol). The shape memory properties of the shape memory structural support members can resist permanent deformation of wings 130, 131 and can help prevent, for example, wrinkles of the wings and / or boundary 133 from accumulating beneath the adhesive layer 340.

[0140] In some embodiments, the support layer may include at least two overlapping material layers (e.g., a top base layer 300 and a bottom base layer 330). In some embodiments, the bottommost base layer (e.g., bottom base layer 330) and / or the topmost base layer (e.g., top base layer 300) of the flexible body 110 may include more than one layer. Each layer may include polyethylene terephthalate (PET) and / or polyurethane (PU). In many embodiments, the PET-containing layer may provide structural support for the flexible body. PET may be the most rigid or stiff material present in the various layers of the flexible body 110. The structurally supportive layer may also provide resistance to wrinkles from adjacent, more wrinkle-prone (e.g., less rigid) layers. In many embodiments, the polyurethane-containing layer may provide a comfortable and / or breathable barrier for the flexible bodies 110, 310. Polyurethane may be the least rigid material present in the various layers of the flexible body 110, or at least not the most rigid material. Polyurethane can typically form a waterproof seal that prevents water from entering through the surrounding environment and penetrating between the adhesive layer 340 and the subject's skin. The barrier layer may be particularly advantageous for allowing the subject to shower. Providing a showerable physiological monitoring device can improve user compliance and / or promote or increase the duration of long-term wear. The polyurethane layer is typically breathable, allowing evaporation through the polyurethane layer, especially when the polyurethane layer is relatively thin. In some embodiments, a perforated PET layer may be located between the adhesive layer 340 and the polyurethane layer. In some embodiments, the polyurethane layer may be located between the adhesive layer 340 and the perforated PET layer. In some embodiments, the bottommost base layer 330 may be integrated with the adhesive layer, for example, in a spun polyurethane that allows the adhesive to form around a lattice or mesh structure provided by the base layer.

[0141] Figures 5B to 5G schematically depicted Figure 5A The illustration shows a bottom view of various constituent layers of the embodiment and includes examples of non-limiting dimensions (in millimeters) of the embodiment. All the different layers forming wings 231, 232 may include overlapping holes configured to accommodate electrodes 350 as described elsewhere herein. Figure 5B The support layer 202 (e.g., polyurethane) that forms the main structure of the flexible body is shown. Figure 5C Show Figure 5B A close-up of illustration A depicted in the text. Figure 5D The diagram shows an additional layer configured to form "butterfly wings" 203, which support the extension of the adhesive 240, as shown. Figure 5G As shown, this can be used to limit the chance of the adhesive folding back and sticking to itself during application. The butterfly wing layer 203 can extend between the hinge lines 134. Figure 5E A perforated layer 204 (e.g., a perforated PET layer) is shown, which includes pores 332 for providing structural support to wings 231, 232 while allowing moisture transport. As shown, the perforated layer 204 may extend discontinuously between wings 231, 232. Figure 5F Show Figure 5E A close-up view of illustration A depicted in the text. Figure 5G Two adhesive layers 240 are depicted. As shown in the comparison of the different layers, the perforated layer 204 may not extend along the entire length of the adhesive layer 240 along the longitudinal axis. The adhesive layer 240 may extend inward toward the housing 315 beyond the hinge line 134 to form a flap 249, which is supported on the top surface by the butterfly wing layer 203 and adheres to the subject's skin on the bottom surface but not to the overlying hinge portion of the support layer 202. In some embodiments, this feature (such as...) Figure 5B As shown), the hinge portion 1001 of the support layer 202 is fixed to the subject's skin by the proximal portion and the distal portion of the adhesive 240, which can distribute the stress applied to the adhesive during wear and minimize the peeling force that can more easily weaken the adhesion to the skin. Figure 5H A three-dimensional view of the physiological monitoring device 200 is depicted.

[0142] In various embodiments, the adhesive layer (e.g., adhesive layers 340, 240, or any other adhesive layer described herein) may be replaceable. Because a new adhesive layer 340 can replace an adhesive layer 340 that has begun or has lost its basic ability to adhere the device 100 to the subject's skin, replacing the adhesive layer 340 can extend the wearing duration of the physiological monitoring device 100. To replace the adhesive layer 340, the top surface of the adhesive layer 340 can be separated from the bottom surface of the base layer of the flexible body 110 (e.g., the bottom surface of the bottom base layer 330). The physiological monitoring device 100 can be removed from the subject's body, and then the adhesive layer 340 can be separated from the flexible body 110. The adhesive layer 340 can be removed most easily by peeling the adhesive layer 340 from the flexible body 110 starting from the inner corner of the adhesive layer 340 (e.g., the corner closest to the housing 115). Specialized removal devices can be provided to facilitate the removal of the adhesive layer 340. For example, the removal device may include a thin flat blade configured to be inserted between the adhesive layer 340 and the flexible body 110. The removal device may include a handle extending from the blade. The handle may extend from the blade at an angle such that the blade can be positioned parallel to the flexible body, the flexible body can be supported on a plane, and the handle can be positioned and held above the plane. For example, the removal tool may be used to separate the corner of the adhesive layer 340 from the flexible body 110, and then the corner of the adhesive layer 340 may be used to pull or peel off the remaining portion of the adhesive layer 340 from the flexible body 110. The removal tool, or a separate removal tool, may include means for gripping the adhesive layer 340 after it has been separated from the base layer portion of the flexible body 110, such that the removal tool can be used to pull or peel off the adhesive layer 340 from the base layer of the flexible body 110. The replacement adhesive layer 340 may be applied to the flexible body 110 in the same or similar manner as the original adhesive layer 340 was applied to the base layer of the flexible body 110 during the manufacture or assembly of the physiological monitoring device 100. For example, the adhesive layer 340 can be formed on a back layer on the bottom surface of the adhesive layer 340, and the back layer can be removed after the top surface of the adhesive layer is adhered to the flexible body 110. In some embodiments, an alternative adhesive layer can be applied to the flexible body 110 using a template or tool to achieve easy and accurate positioning relative to features on the flexible body 110.

[0143] In some embodiments, the adhesive layer 340 may consist of multiple layers. In some examples, if adhesion failure occurs or for other suitable reasons, the user may remove the physiological monitoring device 100 and the bottommost layer of 340 that is in direct contact with the skin. This removed layer may be the entire surface of 340, thereby exposing the new adhesive layer beneath, or it may be a ring-shaped area of ​​340, thereby exposing the new layer only in a portion of the adhesive, or it may be some other smaller areas smaller than the entire area. In some embodiments, the “used” adhesive layer may be in a patterned shape distributed on the surface of the adhesive 340, resulting in a mixed distribution of fresh and “used” adhesive on its surface. Similar to replacing the adhesive, renewing the adhesive by removing some or all of the layers that have recently been in contact with the skin may have the effect of extending the duration of wear. In this embodiment, the multiple layers of 340 may be constructed by a combination of adhesive and a release liner, wherein the release liner may be siliconized to be non-adhesive on the top surface but more permanently adhered to its bottom surface, and vice versa. The siliconization may be adjusted to allow for the intentional removal of layers without creating undue challenges while maintaining adhesion to the body. Furthermore, in some examples, the adhesive layer can be removed using a pull tab built into the layer. Additionally, removal can also be achieved by attaching a tool that adheres more firmly to the "used" adhesive than the release liner. In embodiments, the adhesive can be integrated within a lattice or mesh substrate, allowing it to be separated from other layers of adhesive without losing integrity. In some embodiments, the physiological monitoring device 100 can have exposed adhesive rings without needing to be removed from the user's skin. The internal shape of the adhesive on each wing can remain adhered when the rings are removed, exposing new adhesive and enabling extended wear. Adhesion failure typically begins at the outermost edge of the adhesive, so this method of only updating the rings on the outer layer can help extend wear time while minimizing interruptions to data collection and also increasing the likelihood that the user will continue wearing the device.

[0144] In some embodiments, a pull cord (not shown) may be sandwiched between the adhesive layer 340 and the bottom substrate layer 330, embedded in the adhesive layer 340, or partially embedded in the adhesive layer 340 and partially sandwiched between the adhesive layer 340 and the bottom substrate layer 330. The pull cord may have a free tail end proximal to the adhesive layer 340 extending beyond its peripheral edge. The pull cord may extend through a surface region of the adhesive layer 340 according to a specific pattern. In some embodiments, the pull cord may closely follow or be along the peripheral edge of the adhesive layer 340. In some embodiments, the pull cord may closely follow the outer diameter of the electrode 350. In some embodiments, the pull cord may form a substantially closed loop around the surface region of the adhesive layer 340. For example, the distal tail end may be immediately adjacent to the proximal free tail end. The distal tail end may extend freely beyond the peripheral edge of the adhesive layer 340 like the proximal free tail end, or it may be within the surface region of the adhesive layer 340. The pull cord may be configured to assist in removing a removable adhesive layer from the substrate layer 330 or from another layer within the adhesive layer 340. Pulling the free end of the pull cord (e.g., pulling the free end of the pull cord across the bottom surface of the adhesive layer 340) may cause the pull cord to cut through the adhesive layer 340 and / or separate the adhesive layer 340 or a portion thereof from the base layer of the flexible body 110 (e.g., lift away). In some embodiments, the pull cord may remove the peripheral boundary region (e.g., annular region) of the adhesive layer 340 from the inner central portion of the adhesive layer 340. The boundary region and / or other portions of the adhesive layer 340 may be lifted away from the bottom base layer 330 or other layers within the adhesive layer 340. Forming a boundary line between different portions of the adhesive layer 340 may facilitate the removal of these portions from the bottom base layer 330. The new cut edges created by the pull cord in the adhesive layer 340 may provide a starting point for peeling the adhesive layer 340 from the bottom base layer 330. These edges may be more easily separated from the natural or original peripheral edges of the adhesive layer 340, especially where the natural edges are flush with the edges of the bottom base layer 330. It may be easier to lift the cut edge of the adhesive layer away from a lower surface, such as the bottom substrate layer 330, than to separate the two thin edges from each other at the outer peripheral edge of the flexible body 110. In some embodiments, pulling a cord can at least partially lift the cut edge of the adhesive layer 340 away from the bottom surface of the bottom substrate layer 330, making subsequent peeling of the adhesive layer 340 easier. In some embodiments, the adhesive layer 340 may be naturally separable or separable along a path not formed by the cord. For example, the adhesive layer 340 may be made particularly brittle along a contour similar to the cord, such as by providing perforated paths in the surface area of ​​the adhesive layer 340. The cord may be used in conjunction with other removal methods and / or tools disclosed elsewhere herein.

[0145] In some embodiments, the adhesive layer 340 may extend completely to the edge or boundary of the base layer (e.g., including the top base layer 300), such that the top surface of the adhesive layer 340 adheres to the bottom surface of the boundary 133 and the bottom surface of the bottom base layer 330. In some embodiments, the flexible body 110 may not include the boundary 133 and the adhesive layer may extend to the edge of the bottom base layer 330. Embodiments including a replaceable adhesive layer 340 may be particularly suitable for an adhesive layer 340 that extends to the outer edge or boundary of the flexible body 110.

[0146] Figures 8A to 8J An embodiment of a physiological monitoring device 400 is shown. In some embodiments, the physiological monitoring device 400 may include a housing 415 connected to electrode traces 411, 412, such as Figure 8A and Figure 8B As shown. Figure 8A A side view of the housing 415 and traces 411, 412 is shown. Figure 8B A top view of the housing 415 and traces 411, 412 is shown. Traces 411, 412 may extend from the side and / or bottom of the housing 415. Traces 411, 412 may be fixedly coupled to electrodes 350 at the ends opposite to the housing 415. For assembling the physiological monitoring device 400, the housing 415 and traces 411, 412 may be coupled (e.g., adhered) to the bottom surface of the flexible body 410, such as... Figure 8C As shown. The flexible body 410 can be a single material unit with a generally continuous flat surface. The profile or shape of the flexible body 410 can be the same as other flexible bodies described herein, and can generally be as follows: Figure 8C and Figure 8D The shape can be circular, or any other suitable shape. In some embodiments, the flexible body 410 may include holes for receiving the electrode 350. In some embodiments, the electrode may be embedded in the flexible body 410 (e.g., the electrode may be disposable). The flexible body 410 may include one or more constituent layers as described elsewhere herein, including an adhesion layer and a boundary layer. The constituent layers may extend continuously across a surface region of the flexible body 410 or may extend proportionally across discrete sub-regions. The continuous flexible body 410 may be monolithic and continuous, covering the housing 415 and traces 411, 412. In some embodiments, the flexible body 410 may be cut to allow for reduced load on the housing 415 while covering traces 411 and 412. In embodiments, as shown... Figure 8CAs shown, the continuous flexible body 410 can be cut along a path surrounding the floating portion 420 or butterfly wing portion, which surrounds the rigid body and / or housing 415 and at least a portion of the length of traces 411, 412 extending from the rigid body and / or housing 415, but excluding electrodes. The flexible body 410 can be configured with a pre-cut structure before being attached to the housing 415. In some embodiments, the flexible body 410 may include perforations or other brittle features that allow the floating portion 420 to be easily separated from the rest of the flexible body 410. In some embodiments, the pre-cut region of the flexible body 410 may include a hinge that supports the trace as it is lifted off the skin. The bottom surface of the floating portion 420 may be free of adhesive, allowing the floating portion 420 to be freely lifted off the subject's skin, such as... Figure 8D As shown and elsewhere in this document. In a particular embodiment, prior to the hinge point, the bottom surface of the distal end of traces 411, 412 may be coated with an adhesive to better secure the electrodes to the skin.

[0147] In some embodiments, the housing 415 may include sensing electrodes 350, such as Figure 8E As shown in (outline view) and 8F (top view). The flexible adhesive body 410 can be placed on top of the housing 415, as... Figure 8G As shown. In some embodiments, the housing 415 may include an electrical connector 1003 on its outer surface capable of electrically connecting to traces integrated into the flexible body 410. This arrangement allows the traces and electrodes to be disposable and easily replaceable. The connection between the traces and the housing may be achieved using a conductive adhesive, conductive glue, conductive gel, or other suitable conductive material. In some embodiments, a top protective layer (not shown) may be disposed on the traces 411, 412, and optionally on the rigid body 410 after they are attached to the flexible body 410. The top protective layer may be attached (e.g., adhered) to the flexible body 410. The top protective layer may be attached to the flexible body before the upper portion of the flexible body 410 is cut, such that an overlapping cut is applied to the flexible body 410 and the top protective layer. In some embodiments, the top protective layer may be provided in a pre-cut form.

[0148] The flexible body 410 of the physiological monitoring device 400 can be replaceable. The flexible body 410 can be removed from the housing 415 and the electrode traces 411, 412, and a replacement flexible body 410 can be reused in the same manner as when assembling the flexible body 410. In some embodiments discussed herein, the flexible body 410 may include the electrode traces 411, 412, and the flexible body 410 can be removed from the housing 415 to replace it with another flexible body in the same location. This embodiment of the physiological monitoring device 400 can provide a convenient method for replacing the adhesive layer of the physiological monitoring device 400 after the adhesive layer has begun to wear and / or peel off, thereby allowing for a longer service life of the device 400.

[0149] Physiological monitoring device

[0150] Figures 6A to 6H Depicting something similar to Figures 1A to 5H An embodiment of the physiological monitoring device 700 depicted in the diagram. Figure 6A A three-dimensional diagram of the physiological monitoring device is depicted. (As shown in...) Figure 5A Similarly, the physiological monitoring device 700 may include wings 730 and 731, each asymmetrical about its longitudinal axis, extending generally between electrode interface portions 702 covering electrodes located on the underside of the wings. Electrode traces 704 extend from the housing to the electrodes to provide electrical communication between the electrodes and the central housing. As described above. Figure 5A Similarly, one of the wings 730 may include a body disproportionately distributed above the longitudinal axis, while the other wing 731 may include a body disproportionately distributed below the longitudinal axis. Thus, wings 730, 731 may allow the flexible body to be asymmetrical about the transverse axis, perpendicular to the longitudinal axis, and extending through the housing 706, which may include a patient trigger 707, similar to other patient triggers disclosed in this section or elsewhere in this specification. As described elsewhere herein, in some embodiments, the patient trigger may comprise 10% to 30% of the total top area, such as about 20% or about 23% of the top area, such as about 22.8% of the total top area. In some embodiments, the patient trigger may comprise more than about 20%, more than about 30%, more than about 40%, more than about 50%, or more than about 75%. In some examples, the patient trigger may comprise the entire top surface of the housing. Wings 730, 731 may include the same shape, such as Figures 6A to 6CAs shown, these shapes are inverted or flipped around the longitudinal and transverse axes. In some embodiments, the wings may be asymmetrical in size and shape; for example, the upper wing 730 may be larger than the lower wing 731, or vice versa. The shapes of the wings 730 and 731 may differ so that the relative shape of the upper wing 730 differs from that of the lower wing 731. In some examples, the upper wing 730 may withstand greater tension than the lower wing 731, or vice versa, so different sizes and shapes of the two wings may help to handle unique force vectors during use of the physiological monitoring device. The wing configuration may be particularly well-suited to arranging electrodes diagonally relative to the height of the subject, potentially reducing peeling due to gravity. Those skilled in the art will understand that the orientation of the wings can be changed so that the wings are mirror-image rather than disproportionately distributed above or below the longitudinal axis. Furthermore, those skilled in the art will understand that, as described herein, the shape of such wings may differ from the generally circular shape depicted in Figures 5 and 6. For example, the wings may be angular, such as squares, rectangles, triangles, pentagons, or any suitable polygons. These polygons may have rounded corners to reduce the likelihood of peeling from the corners. Liners 708, such as those described elsewhere herein, can be used to cover and protect any adhesive before the physiological monitoring device is applied to a patient or user. In an embodiment, the liner may be divided into two parts, one on each wing.

[0151] In some embodiments, the additional visual pattern 710 may extend via wings. The visual pattern 710 can be any suitable size or shape to outline the electrode traces and the shape of the wings; for example, the visual pattern 710 can be in the form of lines, such as circular lines, to reflect the outline of the electrode traces and the shape of the wings. In some embodiments, there may be one, two, three, four, or more lines. In some embodiments, because other transparent adhesive layers may become visually unacceptable to the user due to wear (e.g., if the adhesive layer becomes cloudy due to foreign matter and / or moisture absorption), the visual pattern can be formed by a pattern of dots, shapes, or other combinations to maintain the visual cleanliness of the device. In some embodiments, the visual pattern may have another functional purpose, namely, to remind the user how long they have been wearing the device, for example, by changing color or wear over time. This change in appearance can remind the user to remove the device when appropriate. Figure 6B A top view of an embodiment of the physiological device 700 is shown, while Figure 6C Showing a bottom view, and Figure 6D1 A side view is depicted. Figure 6C In the image, the flexible electrode 712 is visible. For example... Figure 6D1 As shown, the top housing 714 and bottom housing 716 portions of the housing can be located above and below the flexible body 718. Figure 6E and Figure 6FThe bottom and top sides of the physiological monitoring device 700 are shown, each layer being transparent so that all layers are visible. Each layer will be described in more detail below in an exploded view of the physiological monitoring device 700. Holes 720, similar to those depicted in the embodiment of Figure 5 above, can be located in the base layer above the adhesive layer. As described in more detail above, such pores can provide permeability through one or more layers and can promote the evaporation of moisture from below the adhesive layer through the one or more layers including the pores. Figure 6D2 As shown, in an embodiment, the gasket 719 may be located between an upper housing cover 714 and a lower housing 716 co-molded into one or more housings. The gasket may be pressed down against the adhesive assembly and the ridged interface (as shown below). Figure 6D2 (As shown) or another gasket on the opposite housing to provide waterproofing for the internal electronic hardware. Figure 6D2 As 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 719. Those skilled in the art will understand that ridge 721 can be any suitable shape, such as... Figure 6D2 The depicted ridge. 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.

[0152] Figure 6G An exploded view depicts an embodiment of the flexible body 701 of the physiological monitoring device 700 described in this section and elsewhere in the specification. The housing 706 is not shown. As those skilled in the art will understand, Figure 6G The image in the image is upside down relative to its position on the skin. According to... Figure 6GNumber #7 in the diagram depicts an anti-adhesive liner that protects the adhesive layers 240 / 340 and the hydrogel electrode 350. Directly above the adhesive layers are a perforated layer 204 (containing pores as described herein) and a wing layer 203. In some embodiments, the perforated layer and the wing layer can be made of any suitable material, such as polyethylene terephthalate (PET) and / or polyurethane. Directly above the perforated layer may be a lower substrate layer #1, which may be made of polyurethane. In embodiments, the lower substrate layer may have at least one textured side that can be positioned such that the textured side faces the wing layer #3. In embodiments, the wing layer #3 may also include at least one textured side. This textured side can be configured to face the lower substrate layer #1. Conductive electrode traces can be printed on a separate, additional substrate (311, 312). Alternatively, in some embodiments, the conductive electrode traces can be printed directly on the substrate layer #1. Above the conductive electrode traces may be an upper substrate layer 300. Above the upper base layer may be an additional carrier layer #10, followed by an adhesive layer #11 and a topmost rigid liner #9. Those skilled in the art will understand that this arrangement of layers can be applied to any embodiment of the physiological monitor described herein, such as... Figure 5H , Figures 8A to 8D and Figures 6A to 6F Examples of implementations.

[0153] Figure 6HAn exploded view depicts an embodiment of a housing 706 of a physiological monitoring device 700, through which a flexible body 701 extends, as described in detail above. A top housing cover 714 may include a patient trigger 707. The top housing cover may enclose a circuit board 722. A gasket 723 located beneath the circuit board is configured to maintain a consistent spacing between a conductive contact spring on the underside of the circuit board and a battery terminal / ECG trace contact. The gasket may additionally provide electrical insulation between the circuit board and the battery. Holes may be present in the gasket to allow the conductive contact spring, which is connected to the circuit board, to pass through. A battery terminal 725 may be located beneath the flexible body 701 and the circuit board 722, thereby covering a wave spring 726. In an embodiment, the battery terminal 725 may be wound and adhered to a button cell battery 728. The battery terminal 725 may be configured as a flexible circuit with a conductive via 727 that allows the bottom positive terminal of the button cell battery 728 to approach the front negative terminal, such that both the positive and negative terminals are located on the top side of the battery to engage with the circuit board contact spring. Optionally, one or more battery contacts in the bottom housing may bring the bottom positive terminal of the coin cell close to the front negative terminal for contact with the circuit board. A vent layer 729 may abut against the lower housing portion 716, located above a vent hole 732 in the lower housing. In embodiments, the vent layer may be made of a material that blocks liquid passage while allowing gas passage, such as ePTFE or any other suitable material. The vent hole 732, combined with the vent layer, allows for pressure normalization between the inside and outside of the housing. In embodiments, the vent hole 732, combined with the vent layer, prevents the button and / or trigger 707 from being blown out or inhaled by external air pressure, for example, if the patient is at a different altitude, such as on an airplane. The vent layer may be thin and round, with the adhesive forming a ring at the bottom. The areas of the vent layer coated with the adhesive may be airtight, while the central portion may be permeable but not liquid-permeable. The central portion of the vent layer may be located above the vent hole, thereby allowing gas to enter and exit the housing while restricting liquid entry and exit. In some embodiments, the venting layer can be integrated into the bottom housing by molding it into the bottom housing, or it can be ultrasonically welded to the bottom housing, or adhered to the bottom housing by any suitable means.

[0154] like Figures 7A to 7B As shown, in some embodiments, the butterfly wing layer 203 can be located in the housing 115, 706 (on top of the shell). Figure 6A and Figure 5H Extending directly below the butterfly wing layer 203. The non-adhesive top surface of the butterfly wing layer 203 prevents the shell from adhering to the butterfly wing. In addition, the central portion of the flexible body 110 (e.g., the hinge portion 132) can be configured to float above the subject's skin and above the butterfly wing layer 203. Figure 7AThe outline of a flexible body 110 with hinge lines 134 is schematically shown, between which the flexible body 110 is configured to be lifted off the subject's skin. An adhesive layer 340 may adhere to a cover base layer (e.g., a bottom base layer 330) outside the hinge lines 134 of the flexible body 110 and to a butterfly wing layer 203 between the hinge lines 134. Figure A shows an embodiment where the width of the flexible body 110 extends beyond the diameter of the housing 115. Figures 7B to 7D Various examples of the construction of an adhesive layer 340, including a butterfly wing layer 203 designed to attach to a flexible body 110 and extend beneath a housing 115, are schematically shown. The shape (e.g., outer contour) of the adhesive layer 340 can be configured to mechanically distribute forces across the adhesive layer 340 in a manner that prevents or inhibits peeling of the adhesive layer 340 from the subject's skin, thereby promoting longer wear time. The outer edge of the adhesive layer 340 may typically include a steep angle, particularly where the outer edge of the adhesive layer 340 intersects with the hinge line 134. The steep angle can be configured to enhance the stress distribution through the adhesive layer 340, which maximizes multiple directional vectors of stresses such as shear stress and tensile stress between the adhesive layer 340 and the subject's skin and / or minimizes peeling stress between the adhesive layer 340 and the subject's skin. Shear stress and tensile stress are less likely to cause the adhesive layer 340 to separate from the skin. By transferring stress to a non-peeling vector, long-term adhesion can be improved.

[0155] For example, Figure 7BA flexible body 110 is shown, having a generally resemblance to a protruding bowie, Papillon ears, and / or a round dumbbell. The flexible body 110 may include a longitudinal axis extending from the outer edge of one of the wings 130, 131 to the outer edge of the other wing and symmetrically bisecting the longitudinal axis of the two wings 130, 131. The flexible body 110 may have a transverse axis perpendicular to the longitudinal axis and symmetrically dividing the flexible body 110 (e.g., the bottom base layer 330) to separate the two wings 130, 131. A hinge portion 132 of the flexible body of the device 100 may extend between the hinge lines 134 of the two wings 130, 131. The hinge portion 132 may symmetrically bisect the adhesive layer 340 in the longitudinal direction. The hinge portion 132 may be narrower in the transverse direction than the two wings 130, 131. The hinge portion 132 may be narrower in the transverse direction than the underlying base layer (e.g., butterfly wing layer 203). The outer edge of the flexible body 110 can extend inward from the hinge line 134 toward both the longitudinal and transverse axes. The outer edge may have a curved shape, where it intersects the hinge line 134. In some embodiments, the outer edge may include an inflection point where it transitions from a convex arc to a concave arc. The concave arc may be closer to the transverse axis than the convex arc. The inflection point may be located on the hinge line 134, outside the hinge line 134 (opposite to the transverse axis), or inside the hinge line 134 (on the same side as the transverse axis). The curved edge of the adhesive layer 340 at the intersection with the hinge line 135 can adjust the vector away from the edge by changing the angle of the edge as the edge extends through the hinge line 134, at which point the adhesive layer 340 may be particularly easy to peel off.

[0156] Figure 7C Showing with Figure 7B Another embodiment of the generally similar flexible body 110 is shown. However, as... Figure 7C As shown, the flexible body 110 (which may have an adhesive layer laminated on it) can be configured such that the housing 115 can be at an angle to the transverse axis of the flexible body 110. This configuration allows the subject to wear the physiological monitoring device 100 at an angle while maintaining the longitudinal axis of the housing 115 aligned with the axis extending the subject's height. Any embodiment disclosed herein can be modified in the same manner to reorient the housing 115 to the intended direction in which the flexible body 110 adheres to the subject. Figure 7D Another configuration of the flexible body 110, including a hinge portion 132 configured to resist a peeling mechanism, is shown. The flexible body 110 may include an outer contour that typically has a "Z-shaped" or anti-"Z-shaped" configuration, such as... Figure 7DAs shown. The hinge portion 132 can extend between the hinge lines 134. The hinge portion 132 can extend from the lower inner corner of the flexible body 110 of one of the two wings 130, 131 to the upper inner corner of the flexible body 110 of the opposite wing. In some embodiments, the hinge portion 132 can be generally linear, having a consistent width along its length. In some embodiments, the outer edge of the flexible body 110 can be smooth or slightly rounded at the intersection between the hinge portion 132 and the housing 115 and / or between the portion of the hinge portion 132 and the portion outside the hinge lines 134 of the flexible body 110, such as... Figure 7D As shown. Therefore, there may be no sharp corners along the hinge 132. The “Z-shaped” construction can reduce the length of the edges of the flexible body 110 aligned with and / or parallel to the hinge line 134, which may be the edges of the adhesive layer 340 that are most easily peeled off. The sharp bend between the hinge 132 and the edge along the hinge line 134 increases the shear force aligned with the hinge line 134 and reduces the likelihood of peeling, especially near the intersection between the hinge 132 and the hinge line 134. This can be achieved by minimizing the connection between the hinge 132 and the central housing 115 when the subject's body is in a position that subjectes the patch to torsional forces (e.g. Figure 13B (As shown).

[0157] In some embodiments, during the intended wearing period, such as approximately the following time periods, the subject may replace the top base layer 300 to extend the wearing time and update the device appearance: 6 hours, 12 hours, 1 day, 2 days, 4 days, 1 week, or more than one week. In some embodiments, the top base layer 300 may exist as two separate pieces that do not intersect with the housing 114, such as... Figure 6G As shown, each sheet can be removed individually and replaced with a new back adhesive sheet. Removal can be achieved via a non-adhesive pull tab feature or other protrusion on the base layer 300, whether or not it adheres to the subject's skin. Replacement of the top base layer 300 with a new back adhesive sheet can be achieved in a manner similar to that used in the original application. The top base layer 300 can be supported by a rigid liner and protected by an anti-adhesive liner, wherein the anti-adhesive liner can be removed before application, while the rigid liner can be removed after application to the skin. The top base layer 300 can be a single integral component, such as... Figure 3B As shown, or it can be two or more separate components, such as Figure 6G As shown. Figure 7EAs shown, the top base layer can also be a single integral component connecting portions that do not intersect with the housing 115. The top base layer 300 may include a thin adhesive layer on its bottom surface that connects the top base layer 300 to other substrates of the flexible body 110 and to the subject's skin along boundary 133. Bridging portions 347 may connect the right and left portions of the top base layer 300 located below the two wings 130, 131. Figure 7E A bottom view schematically illustrates a physiological monitoring device 100 including a single top base layer 300 containing a bridging portion 347. In some embodiments, the bridging portion 347 may extend around (e.g., at a height above or below in the horizontal plane) the central portion of a flexible body 110 connected to a housing 115. Figure 7E A physiological monitoring device 100 is shown having bridges 347 extending around a housing 115 in opposite directions. The bridges 347 may include a generally curved or bow-shaped form. The top base layer 300 may include, for example... Figure 7E The shape shown is that of a "headphone". The bottom surface of the bridging portion 347 may be adhesive, such that the bridging portion 347 is configured to adhere to the subject's skin. In some embodiments, the bottom surface of the bridging portion 347 may be non-adhesive, such that the bridging portion 347 does not adhere to the subject's skin. Because the top surface of the bridging portion 347 is exposed when the subject wears the physiological monitoring device 100, the top surface of the bridging portion 347 may be non-adhesive.

[0158] Figure 7E The arrows in the diagram schematically indicate possible preferred directions for removing the top base layer 300 from the flexible body 110, if alternatively possible. The adhesive layer 340 can be removed first from one of the two wings 130, 131. The back adhesive top base layer 300 can be peeled from the flexible body 110 on the side opposite the bridging portion 347 (e.g., starting from the inner corner, as described elsewhere herein), and once the adhesive layer 340 has been removed from one of the wings 130, 131, the back adhesive top base layer 300 can be removed from the other wing 130, 131 by peeling the back adhesive top base layer 300 from the second wing, starting from where the bridging portion 347 intersects with the second wing (e.g., starting from the inner corner). In other embodiments, the back adhesive top base layer 300 can be removed substantially simultaneously from both wings 130, 131 by pulling the bridging portion 347 below and across the bottom surfaces of the flexible body 110 and housing 115. In some implementations, the bridging portion 347 may be cut (e.g., substantially along the center of the bridging portion 347) to create two free ends that can be used to peel off the adhesive layer 340 from each of the two wings 130, 131.

[0159] In some embodiments, the placement of the back adhesive top base layer 300 can be facilitated by applying a single, integral component without features or cutouts. This type of layer can be applied to the top of the entire device 100 for additional fixation during wear, or placed as a replacement after removal of the back adhesive top base layer 300. In other embodiments, the back adhesive top base layer for additional fixation or replacement can be a single component with specific cutouts, such as... Figure 8D As shown, this allows the housing 115 and hinge 132 to float away from the skin.

[0160] Figure 7F Depicting something similar to Figures 7A to 7E Embodiment 390 is an example of an airfoil-shaped embodiment. Here, as... Figures 5G to 5H and Figures 6A to 6H In this design, the wings are asymmetrical, with the larger portion of one wing positioned above the longitudinal line and the larger portion of the other wing positioned below it. However, the wings here include both sharp and blunt notches 394. The sharp notches allow the wings to bend more easily and rotate clockwise or counterclockwise about the z-axis, which extends directly through the center of the hole 396.

[0161] Now refer to Figure 9 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 accommodating the PCBA 120, battery holder 150, battery 160, and any other components housed within the housing 115 when engaged with gaskets 360, 370 between them. Housing members 140, 145 may be made of any suitable material to protect the internal components, such as waterproof plastic. 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 down by the patient when he or she perceives an arrhythmia or other cardiac event. When pressed, the top surface 420 presses down to contact and activate 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.

[0162] Continue to refer to Figure 9The lower housing member 145 can 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”, “protrusions”, etc.) that will contact the patient’s skin during use. The recesses 450 can 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 patient from experiencing the sensation that the monitoring device 100 is detaching when the housing 115 is lifted away from the skin and the seal with the skin is broken, as is the case in currently available devices. In yet another embodiment, the bottom surface 445 of the lower housing member 145 may include a plurality of recesses (recesses rather than protrusions, such as...) for preventing the formation of a seal. Figure 6C shown).

[0163] Now refer to Figure 10A 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 1B In an alternative embodiment, the battery holder 150 may be configured to accommodate one or more batteries. Multiple protrusions 152 provide a stable platform for the battery 160 to be positioned at a fixed distance above the PCBA 120 surface, thereby avoiding unwanted contact with sensitive electronic components, while providing sufficient compression of the spring contacts 235. Figure 10B The protrusion 153 locks the battery 160 in place and resists the upward force of the spring contact 235 on the battery. The battery holder 150 also properly positions the battery 160 to provide sufficient compression of the spring contact 236. The use of the battery holder 150 in conjunction with the spring contacts 235 and 236 allows the battery 160 to be electrically connected to the PCBA 120 while still having additional electronic components between the battery 160 and the PCBA 120 and keeping the assembly compact. The battery holder 150 may include a flexible hook 510 that engages with a corresponding rigid hook 440 of the upper housing member 140. Under normal assembly conditions, the flexible hook 510 remains firmly engaged with the rigid hook 440. For disassembly, the flexible hook 510 can be pushed and bent using a suitable tool through the top housing member 140, thereby disengaging it from the rigid hook 440, and subsequently allowing the removal of the top housing member 140.

[0164] Now refer to Figure 11A and Figure 11B An embodiment is shown in a side cross-sectional view of the physiological monitoring device 100. For example... Figure 6AAs 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 also typically 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. 11. 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.

[0165] 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 11B As shown. The support rod 460 is integral with the lower housing member 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 and / or member 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.

[0166] Reference Figure 12 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 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, the liner 810 may be made of, for example, 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.

[0167] 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.

[0168] Now for reference Figure 13A and Figure 13B In one embodiment, the physiological monitoring device 100 may include 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 housing 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 13A and Figure 13B The diagram illustrates the advantages offered by the combination of the floating rigid hull 115 and the adhesion wings 130, 131. Figure 13A In the middle, the patient is sleeping, while... Figure 13B 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.

[0169] Now refer to Figures 14A to 14F 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 14A 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 14A 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 14BAs 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 14C After 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.

[0170] In the next step, refer to Figure 14D The liner 810 is removed (e.g., peeled off) from the top surface of the flexible body 110. Figure 14E 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 14F 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.

[0171] 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 reused again to build 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.

[0172] 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.

[0173] 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 engagement 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.

[0174] 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.

[0175] 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 tests, such as glucose monitors or other blood testing 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 functionality. 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 bed position, heart rate, and / or ambient electrical or acoustic noise.

[0176] 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.

[0177] Device monitoring and clinical analysis platform

[0178] The following is a detailed description of... Figure 15The systems and methods of the embodiments can selectively extract, transmit, and analyze electrocardiogram signal data and other physiological data from wearable physiological monitors such as those described above with respect to Figures 1 through 14. The systems and methods described below can improve the performance of wearable physiological monitors that simultaneously record and transmit data in multiple ways. For example, selective transmission of extracted data allows for reduced power consumption because the wearable patch does not need to transmit all recorded data. By sending the extracted data, many analyses can be performed outside the wearable device without requiring highly power-consuming and battery-shortening full-fledged onboard rhythm analysis. 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 replacement, battery replacement, or battery charging during the monitoring period. 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.

[0179] Figure 15 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 period 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 the onset or offset of a QRS complex, can be used instead of the R peak to provide an estimate of the RR interval time series. The physical characteristics of the monitoring device are constructed in a manner that enhances signal fidelity, thus high signal fidelity allows for high confidence in the accurate extraction of RR peak data.

[0180] 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.

[0181] 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 from the heart rate monitoring device wirelessly or wiredly. Alternatively, RR interval time series data 902 or other signals can be transmitted from a server 916 that stores data for multiple users.

[0182] 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.

[0183] 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 heart rhythm confidence statistic 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.

[0184] 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.

[0185] 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.

[0186] 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 sensor further described above, 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.

[0187] As mentioned above, a significant challenge with this approach is managing the battery life of wearable sensors without replacement or charging, as replacement and charging reduce 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 address this issue by using novel hardware and software combinations to selectively transmit clinically relevant portions of the ECG from the wearable sensor.

[0188] 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.

[0189] 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.

[0190] 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.

[0191] 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 locate certain (e.g., 10) 90-second events to request full resolution from the device to support comprehensive analysis, such as clinical diagnostics.

[0192] 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.

[0193] 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.

[0194] 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 detected," the application will direct the user to a cardiologist who can provide more diagnostic services, such as the ZIO® service, to support clinical diagnosis and treatment. In a further embodiment, as described elsewhere in the specification, the system can trigger an alarm if specific measurements and / or analyses indicate the need for an alert.

[0195] 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).

[0196] 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 storage, optical discs, 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.

[0197] 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.

[0198] 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.”

[0199] 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.

[0200] 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.

[0201] 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.

[0202] 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.

[0203] 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.

[0204] 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.

[0205] 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. A monitoring device configured to be attached to a user, the monitoring device comprising: The casing, including the processor; Wings, extending from the housing and configured to conform to the user's surface, the wings comprising: Electrodes are configured to detect the user's physiological signals, and the electrodes are electrically connected to the processor; An adhesive layer, attached to the bottom surface of the wing, is configured to adhere the wearable device to the user; and A non-adhesive liner or coating is located on the outer edge of the adhesive layer, the non-adhesive liner or coating being configured to prevent the outer edge from adhering to the bottom surface of the wing, and The wing comprises a first layer made of a first material and a second layer made of a second material, the first layer including perforations through the thickness of the first layer, and the second layer being configured to form a fluid seal to prevent fluid from the surrounding environment from reaching the adhesive layer.

2. The monitoring device according to claim 1, wherein the adhesive layer comprises a plurality of channels.

3. The monitoring device according to claim 2, wherein the channels form a grid.

4. The monitoring device according to any one of the preceding claims, wherein the adhesive layer comprises a moisture-absorbing material.

5. The monitoring device according to claim 4, wherein the moisture-absorbing material is located in the channel.

6. The monitoring device according to claim 1, wherein the second material comprises polyurethane.

7. The monitoring device according to claim 1, wherein the perforation is configured to transport moisture.

8. The monitoring device of claim 1, wherein the perforation through the first layer is configured to provide anisotropic properties to the wing in a plane parallel to the bottom surface of the wing.

9. The monitoring device according to claim 1, wherein the wing includes a structural reinforcement member.

10. The monitoring device according to claim 9, wherein the structural reinforcement member is disposed along the outer periphery of the wing.

11. The monitoring device according to claim 1, wherein the first layer comprises polyethylene terephthalate.

12. The monitoring device according to claim 1, wherein the adhesive layer includes a central void.

13. A monitoring device configured to be attached to a user, the device comprising: The casing, including the processor; A wing, extending from the housing and configured to conform to the user's surface, includes electrodes configured to detect the user's physiological signals and is electrically connected to the processor. An adhesive layer, attached to the bottom surface of the wing, is configured to adhere the wearable device to the user. The adhesive layer includes a plurality of channels extending from the bottom surface of the adhesive layer to the top surface of the adhesive layer, the channels being configured to deliver moisture from the user's surface. as well as A non-adhesive liner or coating is located on the outer edge of the adhesive layer, the non-adhesive liner or coating being configured to prevent the outer edge from adhering to the bottom surface of the wing.

14. The monitoring device of claim 13, wherein each channel extends in a direction perpendicular to the bottom surface and the top surface.

15. The monitoring device according to any one of claims 13-14, wherein the channels are arranged in an array.

16. The monitoring device according to claim 13, further comprising a gap located at the central portion of the adhesive layer.

17. The monitoring device according to claim 13, wherein the channels are arranged in a grid.

18. The monitoring device of claim 17, wherein the adhesive layer comprises adhesive islands separated by channels, the adhesive islands being connected by strips.

19. The monitoring device according to claim 13, wherein the channels are arranged in a radial pattern.

20. The monitoring device according to claim 13, wherein the adhesive layer further comprises a moisture-absorbing material.

21. A wearable device configured to attach to a user, the device comprising: The casing surrounds the processor; A first wing and a second wing, each wing extending from the housing and configured to conform to the user's surface, each wing having a bottom surface, a top surface and a thickness between the bottom surface and the top surface, the first wing being located relative to the housing along a longitudinal axis opposite to the second wing; A first electrode is connected to the first wing, the first electrode is electrically connected to the processor and is configured to conformally contact the user's surface to detect physiological signals; A second electrode is connected to the second wing, the second electrode is electrically connected to the processor and is configured to conformally contact the user's surface to detect the physiological signal; An adhesive layer is attached to the bottom surface of the first wing and the bottom surface of the second wing to adhere the wearable device to the user, the adhesive layer having a lower surface, an upper surface that engages with the bottom surface of the first wing and the bottom surface of the second wing, and a thickness between the lower surface and the upper surface; as well as A non-adhesive liner or coating is located on the outer periphery of the adhesive layer, the non-adhesive liner or coating being configured to prevent the outer periphery from adhering to the bottom surfaces of the first wing and the second wing, and Each wing includes a first layer made of a first material and a second layer made of a second material, the first layer having perforations through its thickness, and the second layer being configured to form a fluid seal to prevent water from the surrounding environment from reaching the adhesive layer.

22. The wearable device of claim 21, wherein each channel extends in a direction perpendicular to the bottom surface and the top surface.

23. The wearable device of claim 22, wherein the channels are arranged in an array.

24. The wearable device according to any one of claims 21-23, further comprising a gap located at the central portion of the adhesive layer.

25. The wearable device of claim 21, further comprising a bridging portion connecting the first wing to the second wing, the bridging portion being narrower than the adhesive layer in a direction transverse to the longitudinal axis.

26. The wearable device of claim 25, wherein the bridging portion extends around the housing.

27. An electronic device for monitoring physiological signals, the device comprising: The casing, which surrounds the hardware processor; A wing, extending from the housing and configured to conform to the user's surface, the wing having a bottom surface, a top surface, and a thickness between the bottom surface and the top surface; An electrode is connected to the wing, and the electrode is electrically connected to the hardware processor; An adhesive layer, attached to the bottom surface of the wing, is configured to adhere the wing to the user; and A non-adhesive liner or coating is located on the outer edge of the adhesive layer, the non-adhesive liner or coating being configured to prevent the outer edge from adhering to the bottom surface of the wing.

28. The electronic device of claim 27, wherein the adhesive layer comprises an aqueous colloid.

29. The electronic device according to any one of claims 27-28, wherein the wing is configured to allow moisture to evaporate from the bottom surface to the top surface through the thickness of the wing.

30. The electronic device of claim 27, wherein the wing and / or the adhesive layer comprises a second material different from the first material forming the adhesive matrix, the second material comprising a fibrous matrix configured to absorb moisture from the user's surface.

31. The electronic device of claim 30, wherein the second material is configured as a layer above the adhesive layer.

32. The electronic device according to any one of claims 30-31, wherein the second material comprises wool, nylon, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), or thermoplastic elastomer (TPE).

33. The electronic device of claim 27, wherein the wing extends laterally beyond the peripheral edge of the adhesive layer to form a boundary surrounding at least a portion of the periphery of the adhesive layer.

34. The electronic device of claim 33, wherein the boundary extends laterally from the peripheral edge of the adhesive layer by at least about 9 mm.

35. The electronic device of claim 27, wherein the non-adhesive liner or coating comprises silicone.

36. The electronic device of claim 27, wherein the adhesive layer is a replaceable adhesive layer, and the peripheral edge of the adhesive layer extends completely to the peripheral edge of the wing at the end of the wing opposite to the housing.

37. The electronic device of claim 36, wherein a pull cord is disposed between the replaceable adhesive layer and the wing and / or embedded within the adhesive layer, the tail end of the pull cord extending beyond the peripheral edge of the wing, wherein the pull cord extends a length over a surface area of ​​the adhesive layer, and wherein pulling the tail end of the pull cord is configured to cut through the adhesive layer and / or lift the adhesive layer away from the wing along the length of the pull cord, the pull cord extending to facilitate removal of at least a portion of the adhesive layer from the electronic device.

38. The electronic device of claim 37, wherein the pull cord extends a certain length near the peripheral edge of the adhesive layer, the pull cord being configured to facilitate removal of at least one boundary portion of the adhesive layer.

39. The electronic device of claim 38, further comprising a tool configured to be inserted between the replaceable adhesive layer and the wing to assist in removing the replaceable adhesive layer from the electronic device.

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