External Cardiac Monitoring Systems

Abstract

A medical device system including: a wearable component configured to surround a portion of a patient's torso, the wearable component defining a plurality of electrically active areas configured to contact the patient's skin and sense electrocardiogram (ECG) signals of the patient's heart; and one or more strain gauges. The system further includes a computing module connected to the wearable component and configured to: sense the ECG signals via the plurality of electrically active areas to measure voltage values ​​from the one or more strain gauges over time; determine a respiratory signal of the patient and a noise signal within the respiratory signal based on the voltage values; determine whether the noise signal within the respiratory signal satisfies a threshold condition; and discontinue sensing of the ECG signal based on a determination that the noise signal satisfies the threshold condition.

Description

[Technical Field]

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 485,086, filed February 15, 2023, entitled "EXTERNAL CARDIAC MONITORING SYSTEM," the entire contents of which are incorporated herein by reference.

[0002] FIELD OF THE INVENTION FIELD OF THE DISCLOSURE The present disclosure relates to medical devices, and more particularly to external medical devices configured to detect signals from a patient. [Background technology]

[0003] In some examples, the cardiac monitoring device may be completely external to the patient's body. An external cardiac monitoring device may be connected to the patient's skin, for example, on the patient's torso, and may sense electrical signals from the patient's heart without piercing the patient's skin. The sensed electrical signals may be used to determine whether the patient is experiencing one or more cardiac symptoms and / or other medical conditions. Summary of the Invention

[0004] The present disclosure describes a medical device system including an external cardiac monitoring (ECM) system configured to be worn by a patient to sense electrical signals (e.g., electrocardiogram (ECG) signals) from the patient's heart without piercing the patient's skin. The ECM system may include a wearable component configured to be worn around the patient's body and a computing device secured to the wearable component and electrically connected to one or more sensors on the wearable component. The computing device of the ECM system may sense electrical signals from the patient's tissue via the one or more sensors on the wearable component and determine, for example, whether the patient is experiencing a cardiac symptom (e.g., arrhythmia, tachycardia, etc.) based on the sensed electrical signals.

[0005] In some examples, the present disclosure describes an exemplary method for determining whether a patient is properly wearing an exemplary medical device system. A computing device may determine a noise signal in one or more signals (e.g., an ECG signal, a respiratory signal from the patient) sensed from the patient by the medical device system and compare the determined noise signal with threshold conditions. If the computing device determines that the determined noise signal meets one or more of the threshold conditions, the computing device may interrupt and temporarily cease sensing electrical signals from the patient's heart.

[0006] The exemplary devices, systems, or methods described herein have several advantages over other external cardiac monitoring devices and / or systems. In some examples, the wearable components may enable the medical device system to continuously monitor and / or sense electrical signals from a patient without losing connection between the patient and sensors of the wearable components. In some examples, the medical device system may enable the wearable components and / or computing devices of the medical device system to be reused with a patient and / or with multiple patients. In some examples, an exemplary method of determining whether the medical device system is detecting a threshold amount of noise signals from the patient (e.g., in the sensed electrical signal and / or one or more other sensed signals) and ceasing sensing of the electrical signal if the medical device system detects the threshold amount of noise signals may prevent the medical device system from storing erroneous and / or inaccurate electrical signals, improving the accuracy of determining whether the patient is experiencing a cardiac symptom.

[0007] In some examples, the present disclosure describes a medical device system, the medical device system describing a wearable component configured to surround a portion of a patient's torso, the wearable component defining a longitudinal axis and comprising: an electrically conductive fabric; a plurality of electrically active regions defined by the electrically conductive fabric and disposed along the longitudinal axis of the electrically conductive fabric, each of the plurality of electrically active regions configured to contact the patient's skin and sense an electrocardiogram (ECG) signal of the patient's heart; one or more strain gauges disposed along the longitudinal axis within the electrically conductive fabric; and a recess; and a computing device disposed within the recess. a computing module comprising: a sensing circuit electrically connected to the plurality of electrically active areas and one or more strain gauges; and a processing circuit configured to: cause the sensing circuit to sense ECG signals via the plurality of electrically active areas and measure voltage values ​​from the one or more strain gauges over time; determine a respiratory signal of the patient and a noise signal in the respiratory signal based on the voltage values; determine whether the noise signal in the respiratory signal satisfies a threshold condition; and cause the sensing circuit to discontinue sensing of the ECG signal based on a determination that the noise signal satisfies the threshold condition.

[0008] In some examples, the present disclosure describes a medical device system comprising: a wearable component configured to surround a portion of a patient's torso, the wearable component defining a longitudinal axis and comprising: an electrically conductive fabric; a plurality of electrically active areas defined by the electrically conductive fabric and arranged along the longitudinal axis of the electrically conductive fabric, each of the plurality of electrically active areas configured to contact the patient's skin and sense electrocardiogram (ECG) signals of the patient's heart; and a recess; and a computing module disposed within the recess, the computing module comprising: a sensing circuit electrically connected to the plurality of electrically active areas; and a processing circuit configured to cause the sensing circuit to sense ECG signals via the plurality of electrically active areas; determine a noise signal in the sensed ECG signals; determine whether the noise signal satisfies a threshold condition; and cause the sensing circuit to discontinue sensing the ECG signals based on a determination that the noise signal satisfies the threshold condition.

[0009] In some examples, the present disclosure describes a computing device configured to sense electrocardiogram (ECG) signals from a patient, the computing device comprising: a sensing circuit including one or more sense amplifiers; a processing circuit configured to sense signals from one or more sensors on a wearable component that contacts the patient's skin via the sensing circuit; determine a noise signal within the sensed signals; determine whether the noise signal meets a threshold condition; determine that the patient is improperly wearing the wearable strap based on a determination that the noise signal meets the threshold condition; and cause the sensing circuit to discontinue sensing of the ECG signals based on a determination that the patient is improperly wearing the wearable component; and a securing mechanism configured to electrically connect the computing device and the one or more sensors.

[0010] In some examples, the present disclosure describes a method, the method including: sensing, by a sensing circuit of a computing module, an electrocardiogram (ECG) signal of a patient's heart via a plurality of electrically active areas disposed on a wearable component configured to be worn by the patient and to contact the patient's skin, the wearable component configured to surround a portion of the patient's torso, the wearable component comprising an electrically conductive fabric defining a plurality of electrically active areas along a longitudinal axis of the wearable component and a recess configured to hold the computing module; determining, by a processing circuit of the computing module, a noise signal in the ECG signal based on the ECG signal; determining, by the processing circuit, whether the noise signal satisfies a threshold condition; determining, by the processing circuit, that the patient is improperly wearing the wearable component based on a determination that the noise signal satisfies the threshold condition; and causing the sensing circuit to discontinue sensing of the ECG signal based on a determination that the patient is improperly wearing the wearable component.

[0011] The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims. [Brief explanation of the drawings]

[0012] [Figure 1] FIG. 1 is a conceptual diagram illustrating an exemplary medical device system including an external cardiac monitoring system.

[0013] [Figure 2A] FIG. 2 is a conceptual diagram illustrating a front view of the external cardiac monitoring system of FIG. 1.

[0014] [Figure 2B] FIG. 2 is a conceptual diagram illustrating a rear view of the external cardiac monitoring system of FIG. 1.

[0015] [Figure 2C]FIG. 2 is a conceptual diagram illustrating a top view of the external cardiac monitoring system of FIG. 1.

[0016] [Figure 2D] FIG. 2 is a conceptual diagram illustrating a front view of the external cardiac monitoring system of FIG. 1 without the computing device of the external cardiac monitoring system.

[0017] [Figure 3A] 2 is a conceptual diagram illustrating the exterior of the front housing of the computing device of FIG. 1.

[0018] [Figure 3B] 2 is a conceptual diagram illustrating the interior surface of the front housing of the computing device of FIG. 1.

[0019] [Figure 3C] 2 is a conceptual diagram illustrating the exterior of the rear housing of the computing device of FIG. 1.

[0020] [Figure 3D] 2 is a conceptual diagram illustrating the interior surface of the rear housing of the computing device of FIG. 1.

[0021] [Figure 4A] FIG. 2 is a conceptual diagram illustrating a front view of the external cardiac monitoring system of FIG. 1 having multiple expandable members.

[0022] [Figure 4B] FIG. 4B is a conceptual diagram illustrating a top view of the external cardiac monitoring system of FIG. 4A.

[0023] [Figure 5] FIG. 2 is a functional block diagram illustrating an example configuration of the computing device of FIG. 1.

[0024] [Figure 6] FIG. 2 is a conceptual diagram illustrating an example medical device system including the example cardiac monitoring system of FIG. 1 and one or more external monitoring devices.

[0025] [Figure 7A] FIG. 1 is a flow diagram illustrating an exemplary method for sensing a signal from a patient using an exemplary medical device system.

[0026] [Figure 7B] FIG. 1 is a flow diagram illustrating an exemplary method for expanding an expandable member of an exemplary medical device system.

[0027] [Figure 8] FIG. 10 is a flow diagram illustrating another exemplary method for sensing electrical signals from a patient using an exemplary medical device system. DETAILED DESCRIPTION OF THE INVENTION

[0028] This disclosure describes external cardiac monitoring (ECM) systems, components of ECM systems, medical device systems including ECM systems, and related technology that uses and forms ECM systems. An exemplary ECM system may include a wearable component (e.g., a wearable strap, a wearable vest, etc.) including one or more sensors (e.g., electrodes, electrically active areas defining the electrodes) placed in contact with a patient's skin, and a computing device secured to the wearable component. The computing device may sense electrical signals of the patient's heart through the patient's skin via the one or more sensors and store, transmit, and / or analyze the sensed electrical signals (e.g., to determine whether the patient is experiencing a cardiac symptom). The computing device may determine whether the patient is using the ECM system appropriately based on the sensed electrical signals and / or one or more other sensed signals from the patient (e.g., the patient's respiratory signal) and may discontinue sensing of the electrical signals to prevent recording and / or use of inaccurate sensed electrical signals.

[0029] A medical device system may include an exemplary ECM system that may be used to monitor a patient's heart and sense electrical signals (e.g., in the form of electrocardiogram (ECG) signals) from the patient's heart. Use of an external monitoring system, such as the ECM systems described herein, may allow a patient to attach and / or remove components of the ECM system (e.g., wearable components, one or more sensors) from the patient's body. Use of an external monitoring system may also reduce the monetary cost of the medical device system and reduce and / or eliminate the need for implanting a medical device within the patient's body. While the sensed electrical signals are described primarily with reference to ECG signals, other electrical signals corresponding to cardiac activity of the patient's heart may also be sensed by the exemplary ECM system and used to make one or more of the exemplary determinations made by the ECM system described herein. For example, any of the exemplary determinations made by the ECM system described herein may be made using impedance, sounds from the heart, acceleration detected by a multi-axis accelerometer (e.g., a three-axis accelerometer), respiratory activity (e.g., detected by a strain gauge), and / or pulse oximetry (e.g., detected by an optical system).

[0030] Other external monitoring systems may use adhesives (e.g., adhesive patches) to secure one or more sensors of the external monitoring system to the patient's body. The use of adhesives may limit the amount of time a patient may wear the external monitoring system, cause discomfort to the patient, and / or limit the reusability of components of the external monitoring system. For example, the adhesive and one or more sensors of the external monitoring system may not be reusable and may need to be replaced upon subsequent use of the external monitoring system.

[0031] In some examples, one or more sensors of an external monitoring system may move around the patient's body and / or lose contact with the patient's skin. Movement or loss of contact of one or more sensors may cause the external monitoring system to fail to sense a cardiac ECG signal or to sense an inaccurate ECG signal (e.g., an ECG signal that is not representative of a cardiac symptom, an ECG signal that is altered and / or distorted by the position of the one or more sensors relative to the heart).

[0032] Exemplary ECM systems described herein include a wearable component that includes or defines one or more sensors. The one or more sensors may include, but are not limited to, electrodes, electrically active areas defining electrodes, strain gauges, capacitors, etc. The wearable component may be worn, hooked, wrapped, or otherwise removably secured around the patient's body (e.g., around the patient's torso). When worn on the patient, the wearable component may place one or more of the sensors (e.g., electrodes) in contact with and / or adjacent to the patient's skin at one or more predetermined locations.

[0033] An exemplary ECM system may include a computing device removably secured to the wearable component, e.g., within a recess defined by the wearable component. Once secured to the wearable component, the computing device may be electrically connected to one or more sensors of the wearable component and sense one or more signals from the patient (e.g., ECG signals, respiratory signals). The wearable component and computing device may be reused by the patient or another patient without requiring the use of new components.

[0034] In some examples, the computing device determines whether the patient is properly wearing the ECM system and / or whether one or more sensors are placed in contact with the patient's body at predetermined locations. The computing device may determine a noise signal in the sensed signal and determine that the one or more sensors are not placed at the predetermined locations based on a determination that the noise signal satisfies one or more threshold noise conditions.

[0035] If the computing device of the ECM system determines that one or more sensors are not installed in a predetermined position and / or that the wearable components are improperly worn, the computing device may suspend sensing of ECG signals from the patient, for example, to prevent storage, transmission, and / or use of inaccurate, altered, and / or distorted ECG signals. The computing device may suspend sensing of ECG signals for a predetermined period of time, such as in response to user input, until the noise signal no longer meets one or more threshold conditions. In some examples, the computing device may output a notification and / or alert to the user to inform the user of the need to adjust the wearable components. The computing device may be configured to resume sensing of ECG signals, for example, to allow the patient to re-adjust the ECM system and / or one or more sensors around the patient's body. In some examples, the computing device suspends sensing of electrical signals by saturating one or more sensing components (e.g., sense amplifiers) of the computing device, temporarily powering off the computing device, sending a notification to an external device accessible to the patient or clinician, etc.

[0036] Cessing the sensing of ECG signals in response to determining that one or more sensors are not placed in a predetermined location on the patient's body may have several advantages over other external monitoring systems. Cessing the sensing of ECG signals may improve the battery life and power efficiency of the computing device by reducing and / or preventing the sensing, transmission, and / or analysis of inaccurate or distorted ECG signals. The suspension may also improve the ECG storage capacity of the computing device by reducing and / or preventing the storage of inaccurate or distorted ECG signals in the computing device's memory. The suspension may also increase the accuracy of any determinations (e.g., of a patient experiencing a cardiac symptom) by the computing device and / or one or more other computing devices and / or systems of the exemplary medical device system by reducing and / or preventing the use of low-quality, inaccurate, and / or distorted ECG signals in the determinations.

[0037] 1 is a conceptual diagram illustrating an example medical device system 100 including an external cardiac monitoring (ECM) system 104. As shown in FIG. 1, the medical device system 100 includes an ECM system 104 that includes a wearable component 106 and a computing device 108 affixed to the wearable component 106. The computing device 108 may communicate with an external device 110, the network 112, and / or one or more computing devices 114 via a network 112.

[0038] The wearable component 106 is configured to be worn by the patient 102, for example, around the torso 103 of the patient 102. The wearable component 106 may include, but is not limited to, a wearable strap, a wearable vest, a wearable belt, wearable suspenders, or any other wearable design configured to place sensors in contact with the skin of the patient 102 and around the torso 103. The wearable component 106 includes one or more sensors configured to sense signals from the patient 103 corresponding to physiological metrics of the patient 103. Each of the one or more sensors may include one or more sensing components (e.g., electrodes). For example, the one or more sensors may sense an electrical signal (e.g., an ECG signal) corresponding to the electrical activity of the patient's 102's heart, a respiratory signal corresponding to the patient's 102's respiration rate (RR), etc. The one or more sensors may include, but are not limited to, electrodes, electrically active areas defining electrodes, strain gauge sensors, capacitors, or one or more other sensors configured to sense cardiac electrical activity and / or respiratory activity of the patient 102. The sensors described herein are primarily placed around the torso 103, although in some examples, the one or more sensors may be placed at other locations on the patient's 102 body (e.g., around the patient's 102 shoulders).

[0039] The wearable component 106 places at least some of the one or more sensors (e.g., one or more electrodes) in contact with the skin of the patient 102, for example, at predetermined locations on the torso 103 of the patient 102. The wearable component 106 places the sensors in contact with the skin without the use of adhesives or other fastening mechanisms. The wearable component 106 may be put on or removed by the patient 102 and may be reused by the patient 102 or one or more other individuals (e.g., another patient).

[0040] The computing device 108 includes computing circuitry (e.g., sensing circuitry, processing circuitry) disposed within a housing removably secured to the wearable component 106, e.g., within a recess defined by the wearable component 106. The computing device 108 may be electrically connected to one or more sensors on the wearable component 106 and configured to sense signals from the patient 102 via the one or more sensors on the wearable component 106. The computing device 108 may sense ECG signals from the heart of the patient 102 via the one or more sensors on the wearable component 106 and in a memory of the computing device 108, and / or transmit the sensed ECG signals to the external device 110, the network 112, and / or the computing device 114. In some examples, the computing device 108 determines whether the patient 102 has experienced, is experiencing, and / or will experience a cardiac symptom (e.g., arrhythmia, tachycardia, etc.) based on the sensed ECG signals. In some examples, computing device 108 may determine other cardiac symptoms based on the sensed signals, including, but not limited to, decompensated heart failure, exacerbation of chronic obstructive pulmonary disease (COPD), etc. Based on a determination that patient 102 has experienced, is experiencing, and / or will experience a cardiac symptom, computing device 108 may send a notification including the determined and / or sensed electrical signals to external device 110, network 112, and / or computing device 114.

[0041] The computing device 108 determines whether the wearable component 106 is properly worn by the patient 102 and / or whether one or more sensors of the wearable component 106 are placed on the torso 103 at predetermined locations based on sensed signals from the patient 102 (e.g., a sensed ECG signal, a sensed respiratory signal). For example, the computing device 108 may determine whether electrodes on the wearable component 106 are placed on the torso 103 at predetermined locations based on the sensed signals. In some examples, the computing device 108 determines a noise signal within the sensed signals (e.g., a noise signal within the ECG signal, a noise signal within the sensed respiratory signal). Based on whether the determined noise signal satisfies one or more threshold noise conditions, the computing device 108 determines whether the wearable component 106 is properly worn by the patient 102 and / or whether one or more sensors are incorrectly placed on the patient 102.

[0042] If the wearable component 106 is worn improperly, one or more sensors of the wearable component 106 may be incorrectly placed on the patient 102, and the computing device 108 may sense an ECG signal from the patient 102 that is inaccurate, altered, or otherwise distorted (e.g., not representative of the patient's 102's cardiac signal). Based on a determination by the computing device 108 that the wearable component 106 is worn improperly by the patient 102, the computing device 108 may discontinue sensing the ECG signal from the patient 102. The computing device 108 may discontinue sensing the ECG signal from the patient 102 to conserve power and / or storage space and to prevent the computing device 108, the external device 110, the network 112, and / or the computing device 114 from inaccurately determining the patient's 102's condition based on the sensed ECG signal. In some examples, the computing device 108 may output a signal (e.g., an auditory, tactile, or visual signal) that informs the patient 102 that the computing device 108 has stopped sensing ECG signals and / or that the wearable component 106 needs to be adjusted.

[0043] The computing device 108 may temporarily suspend sensing of ECG signals. The computing device 108 may suspend sensing of ECG signals for a predetermined time until it receives user input to resume via the external device 110, the network 112, and / or the computing device 114, until it determines that a noise signal in the sensed signals no longer meets any of the threshold noise conditions, or until it receives other information and / or input by the system 100. The computing device 108 may suspend sensing of ECG signals by temporarily powering off the computing device 108 or by suspending the sensing function of the sensing circuitry of the computing device 108 (e.g., by saturating one or more sense amplifiers of the sensing circuitry of the computing device 108). In some examples, the computing device 108 may turn off automatic detection of cardiac symptoms by the processing circuitry. The computing device 108 may perform any other action to cause the sensing circuitry of the computing device 108 to discontinue sensing ECG signals, to cause the processing circuitry of the computing device 108 to discontinue storing any sensed ECG signals in memory of the computing device 108, and / or to cause the processing circuitry of the computing device 108 to discontinue transmitting any sensed ECG signals to the external device 110, the network 112, and / or the computing device 114.

[0044] In some examples, the wearable component 106 includes one or more expandable members (not shown) disposed along the wearable component 106. The one or more expandable members may be configured to be in fluid communication with a blower disposed on the computing device 108. In response to determining that the wearable component 108 is improperly worn by the patient 102, the computing device 108 may engage the blower and expand the one or more expandable members from a collapsed configuration to an expanded configuration. In the expanded configuration, the one or more expandable members increase the force applied to the one or more sensors to increase contact between the one or more sensors and the skin of the patient 102, for example, to improve sensing of ECG signals from the patient 102. The computing device 108 may expand the one or more expandable members before, instead of, or in addition to discontinuing sensing of ECG signals.

[0045] The external device 110 may be a computing device accessible to the patient 102 and configured to communicate with the computing device 108. The computing device 114 may include one or more computing devices configured to communicate with the computing device 108 and / or the external device 110 via the network 112. The computing device 114 may not be directly accessible to the patient 102. The patient 102 may operate the computing device 108 via the external device 110. One or more other individuals (e.g., clinicians) may operate the computing device 108 via one or more computing devices 114. The external device 110 and / or the computing device 114 may include, but are not limited to, a personal computer, a laptop computer, a tablet, a smartwatch, a smartphone, or one or more other computing devices.

[0046] The network 112 may include one or more cloud computing networks or environments that communicate with the computing devices 108 of the ECM system 104, the external devices 110, and / or one or more computing devices 114. The external devices 110 and / or the computing devices 114 may communicate with the computing devices 108 directly or through the network 112.

[0047] The external device 110, the network 112, and / or the computing device 114 may receive information from the computing device 108 to the patient 102 and / or one or more other individuals (e.g., a clinician) (e.g., information corresponding to the sensed electrical signal, information corresponding to a determination made by the computing device 108). Based on the received information, the external device 110, the network 112, and / or the computing device 114 may determine whether the wearable component 106 is properly worn by the patient 102 and / or whether the patient 102 is experiencing, has experienced, or will experience a cardiac symptom.

[0048] The external device 110 and / or the computing device 114 may receive user input from the patient 102 and / or one or more other individuals and transmit the received user input to the computing device 108. The user input may include, but is not limited to, a command to the computing device 108 to pause sensing ECG signals, a command to the computing device 108 to resume sensing ECG signals, or a request to show a real-time ECG signal from the computing device 108.

[0049] The network 112 and / or the computing device 114 may receive information from the external device 110 and / or the computing device 108 (e.g., information corresponding to the sensed ECG signal, the sensed ECG signal, information corresponding to a determination made by the computing device 108 that the patient 102 has experienced, is experiencing, or will experience a cardiac symptom).

[0050] For purposes of this disclosure, a "front view," "front side," or "front housing" of any component of the medical device system 100 (e.g., wearable component 106, computing device 108) refers to the view or side of the component that faces away from the patient 102 when worn by the patient 102. For purposes of this disclosure, a "rear view," "rear side," or "rear housing" of any component of the medical device system 100 (e.g., wearable component 106, computing device 108) refers to the view or side of the component that faces towards the patient 102 when worn by the patient 102.

[0051] 2A is a conceptual diagram illustrating a front view of the ECM system 104 of FIG. 1. The ECM system 104 includes a wearable component 106 extending from a first end 201A to a second end 201B. The wearable component 106 includes one or more sensors disposed on or defined by the wearable component 106 and a fixed component 212 disposed on an end of the ECM system 104 (e.g., on the first end 201A or the second end 201B). The wearable component 106 may define a recess 202 configured to receive a computing device 108.

[0052] The wearable component 106 includes a flexible material 204 (e.g., fabric) extending from a first end 201A to a second end 201B. The flexible material 204 includes one or more sensors disposed within the flexible material 204, within recesses formed by the flexible material 204, and / or on an exterior surface of the flexible material 204. For example, the wearable component 106 includes a strain gauge 206 disposed within the flexible material 204 along a longitudinal axis 205 extending from the first end 201A toward the second end 201B. In some examples, the wearable component 106 includes one or more electrodes 210A-210F (collectively "electrodes 210") disposed along the longitudinal axis 205. In some examples, the wearable component 106 may include a Zephyr™ strap from the Zephyr™ Performance System available from Medtronic Ltd. of Dublin, Ireland.

[0053] The flexible material 204 may include a dry electrode material (e.g., a dry conductive fabric) or another electrically conductive material. The dry electrode material may include one or more electrically active regions, each defining one of the electrodes 210. The flexible material 204 may be configured to elastically stretch, compress, and / or twist, for example, in response to movement of the patient 102. The flexible material 204 may include a central portion that defines a recess 202. The recess 202 may include components configured to receive the computing device 108, secure the computing device 108 to the wearable component 106, and electrically connect the computing device 108 to one or more sensors, e.g., strain gauges 206 and / or electrodes 210, within the wearable component 106. When worn by the patient 102, the wearable component 106 may position the computing device 108 across the patient's 102 sternum (e.g., as shown in FIG. 1 ), along the side of the patient's 102 torso 103, on the patient's 102 back, and / or at any other location on the patient's 102 body. The flexible material 204 may be at least partially porous, for example, to enhance patient comfort.

[0054] 2A, the flexible material 204 may elastically deform to conform to different body shapes of the torso 103. In some examples, the wearable component 106 may include straps, zippers, and / or buckles configured to adjust the dimensions of the wearable component 106 and / or the flexible material 204 to conform to the torso 103 of the patient 102.

[0055] The electrodes 210 may be positioned along the longitudinal axis 205 such that when the wearable component 106 is worn by the patient 102, the electrodes 210 contact the skin of the patient 102 at predetermined locations around the torso 103 of the patient 102. Each of the electrodes 210 may be configured to sense ECG signals from the skin of the patient 102 and transmit the sensed ECG signals to the computing device 108 via one or more conductors and / or conductive channels within the flexible material 204. In some examples, the wearable component 106 includes two or more conductors disposed within the wearable component 106. In some examples, two of the electrodes 210 (e.g., electrode 210A, electrode 210F) may be configured to be capacitors and may generate an electric field between the two electrodes 210. The capacitance of the generated electric field may change as a result of expansion and contraction of the torso 103 in response to the patient 102's breathing. The computing device 108 may sense the capacitance of the electric field and the change in capacitance via the two electrodes 210.

[0056] The strain gauge 206 may extend from a first end 208A to a second end 208B along a longitudinal axis 205 of the flexible material 204. When the patient 102 breathes while wearing the ECM wearable component 106, the torso 103 of the patient 102 may expand and contract, applying a strain or stress to the strain gauge 206 along the longitudinal axis 205. The applied strain or stress causes the strain gauge 206 to output a voltage value that can be detected by the computing device 108.

[0057] The securing component 212 is configured to secure one end (e.g., second end 201B) of the wearable component 106 to the other end (e.g., first end 201A) of the wearable component 106. In some examples, each end of the wearable component 106 may include a securing component 212 configured to be removably secured to another securing component 212 on the other end of the wearable component 106. The securing component 212 may include, but is not limited to, a Velcro strap, a latch, a button, a zipper, a pin, a strap, a buckle, or any other securing device configured to secure multiple pieces of fabric together.

[0058] FIG. 2B is a conceptual diagram illustrating a rear view of the ECM system 104 of FIG. 1. As shown in FIG. 2B, the rear surface 214 of the wearable component 106, in some examples, does not include any protrusions and / or depressions and is configured to contact the skin of the patient 102 over at least a portion of the rear surface 214. FIG. 2C is a conceptual diagram illustrating a top view of the ECM system 104 of FIG. 1. The wearable component 106 may include a protrusion 216 that extends away from the front surface of the wearable component 106 and defines a recess 202. The recess 202 may extend into the protrusion 216 toward the rear surface 214. The recess may be a blind opening configured to receive the computing device 108. When the computing device 108 is disposed within the recess 202, the computing device 108 may partially protrude from the recess 202, for example, to facilitate insertion and / or removal of the computing device 108 from the recess 202. In some examples, the front surface of the computing device 108 may be flush with the front surface of the protrusion 216 .

[0059] 2D is a conceptual diagram illustrating a front view of the ECM system 104 of FIG. 1 without the computing device 108. As shown in FIG. 2D , the recess 202 extends from the front surface of the protrusion 216 to the inner surface 218 of the recess 202. A plurality of electrical contacts 220 are disposed on the inner surface 218 and configured to engage with one or more securing features on the computing device 108 to electrically connect the electrodes 210, the strain gauges 206, and / or one or more other sensors in the wearable component 106. In some examples, each of the electrical contacts 220 may correspond to two or more sensors in the wearable component 106. In some examples, each of the electrical contacts 220 may correspond to a single sensor in the wearable component 106 (e.g., a single electrode 210, a single strain gauge 206), or a single type of sensor (e.g., only an electrode 210, only a strain gauge 206).

[0060] FIG. 3A is a conceptual diagram illustrating an exterior surface 303 of a front housing 302 of the computing device 108 of FIG. 1. FIG. 3B is a conceptual diagram illustrating an interior surface 304 of the front housing 302 of the computing device 108 of FIG. 1. FIG. 3C is a conceptual diagram illustrating an exterior surface 312 of a back housing 313 of the computing device 108 of FIG. 1. FIG. 3D is a conceptual diagram illustrating an interior surface 318 of the back housing 313 of the computing device 108 of FIG. 1. As shown in FIGS. 3A-3D, the front housing 302 and the back housing 313 may be removably attached to one another to define a housing that houses computing circuitry and / or other components of the computing device 108, as described herein. The front housing 302 and the back housing 313 may be separate and / or integrated, for example, to provide access to computing circuitry and / or power sources within the computing device 108. In some examples, a user (e.g., patient 102, clinician) may separate the front housing 302 and the back housing 313 to replace a removable power supply located within the housing of the computing device 108.

[0061] In some examples, the exterior surface of the front housing 302 may include one or more recesses, protrusions, buttons, knobs, or any other interface and / or control, for example, to allow the patient 102 to interact with and / or send user input to the computing device 108, or to facilitate separation of the front housing 302 and the rear housing 313.

[0062] The inner surface 304 of the front housing 302 may include a power supply 306 for the computing device 108 and one or more inserts 310 extending from the inner surface 304 toward the back housing 314. The power supply 306 may include, but is not limited to, a removable power source such as a coin cell, button cell, or the like. The power supply 306 may be removably secured to the inner surface 304 by a clip 308. The clip 308 may be elastically deformed to allow removal of the power supply 306 from between the clip 308 and the inner surface 304. In some examples, as shown in FIG. 3B , the clip 308 may be electrically conductive, and the inner surface 304 may include electrically conductive contacts 305 for electrically connecting the power supply 306 to the insert 310 and / or computing circuitry and / or other components within the computing device 108.

[0063] The insert 310 may include an electrically conductive material configured to electrically connect the power source 306 and / or the contacts 305 to the computing circuitry and / or other components within the computing device 108 and / or to the inner surface 318 of the back housing 313. In some examples, the insert 310 may extend to contact and electrically connect with the wearable component 106 (e.g., with the electrical contacts 220 with the recess 202). The front housing 302 may include one or more inserts 310.

[0064] In some examples, the power supply 306 may be permanently located within the computing device 108 and may be recharged via an external port, via wireless charging (e.g., inductive charging, etc. In some examples, the power supply 306 may be located in a separate compartment and may be removed, for example, without separating the front housing 302 and the back housing 313.

[0065] The outer surface 312 of the back housing 313 may be configured to contact the inner surface 218 of the wearable component 106 when the computing device 108 is placed in the recess 202. The back housing 313 includes a securing mechanism 314 extending away from the outer surface 312. The securing mechanism 314 may engage the inner surface 218 of the recess 202 to removably secure the computing device 108 to the wearable component 106. In some examples, the securing mechanism 314 may be electrically connected to the power source 306 and computing circuitry and / or other components of the computing device 108 and may transmit electrical signals to and / or receive electrical signals from the wearable component 106. In some examples, the securing mechanism 314 is electrically connected to (e.g., contacts) the electrical contacts 220.

[0066] 3C, the securing mechanism 314 may include a spring clip. In some examples, the securing mechanism 314 may include a locking lug, a locking screw, a locking recess, and / or one or more other securing mechanisms and / or devices configured to removably secure the computing device 108 within the recess 202.

[0067] The back housing 313 may include one or more contacts 316 configured to electrically connect the computing device 108 to the wearable component 106 (e.g., to a sensor of the wearable component 106). The contacts 316 may include an electrically conductive material configured to transmit electrical signals between the computing device 108 and the wearable component 106. In some examples, the contacts 316 may include an opening in the back housing 313 configured to allow a portion of the insert 310 to extend through the back housing 313 and electrically connect to the contacts 316.

[0068] The contacts 316, securing mechanism 314, and computing circuitry of the computing device 108 may be disposed on an inner surface 318 of the back housing 313. The inner surface 318 may include electrical contacts configured to electrically connect the contacts 316, securing mechanism 314, and computing circuitry of the computing device 108. In some examples, as shown in FIG. 3D , the computing circuitry of the computing device 108 may be separated into separate computing modules (e.g., a sensing module 320 including sensors and sensing circuitry, and a processing module 322 including processing circuitry). In some examples, the computing circuitry of the computing device 108 may be disposed within a single computing module. In some examples, each of the electrodes 210 may be electrically connected to a separate sensing module 320. In some examples, the electrodes 210 may be electrically connected to a single sensing module 320.

[0069] FIG. 4A is a conceptual diagram illustrating a front view of the ECM system 104 of FIG. 1 having multiple expandable members 406. The expandable members 406 can be configured to transform between a collapsed configuration and an expanded configuration. FIG. 4B is a conceptual diagram illustrating a top view of the ECM system 104 of FIG. 4A. In such an example, each of the electrodes 210 can be disposed on the rear surface 214 and on top of one or more of the expandable members 406. As shown in FIG. 4B, when expanded, the expandable members 406 can bias the electrodes 210 toward the skin of the patient 102, for example, to increase the contact force between the electrodes 210 and the skin of the patient 102. The increased contact force can increase the sensing capability and / or sensitivity of the electrodes 210, for example, by improving contact between the electrodes 210 and the skin.

[0070] 4A , each of the expandable members 406 is in fluid communication with the recess 202 and / or the computing device 108 via a channel 404. The computing device 108 may include a blower 402 (alternatively referred to as a “fan 402,” “compressor 402,” or “pump 402”). When the computing device 108 is secured within the recess 202, one or more output channels of the blower 402 may align with and / or fluidly connect with the channel 404. In some examples, the blower 402 may be disposed on the wearable component 106 (e.g., within the recess 202). In such examples, the blower 402 may be in fluid communication with the channel 404, and insertion of the computing device 108 may electrically connect the blower 402 and the computing device 108 (e.g., via contacts 220). Once the blower 402 and the computing device 108 are electrically connected, the computing device 108 can send commands (e.g., via electrical signals) to the blower 402 to cause the blower 402 to output air to the expandable member 406 (e.g., to expand the expandable member 406 to an expanded configuration), turn off power, and / or suck air from the expandable member 406 (e.g., to collapse the expandable member 406 to a collapsed configuration).

[0071] In some examples, the blower 402 may take in air from outside the ECM system 104 (e.g., through one or more openings in the computing device 108 and / or the wearable component 106). The blower 402 may then output air into the expandable member 406 through the channel 404 to expand the expandable member 406 to the expanded configuration. The blower 402 may continue to output air into the expandable member 406 until the computing device 108 determines that the expandable member 406 is in the expanded configuration. The computing device 108 may determine that the expandable member 406 is in the expanded configuration based on information and / or signals from one or more sensors on the wearable component 106 (e.g., from the electrodes 210), based on a determination that the blower 402 has output air into the expandable member 406 for a threshold period of time, based on a determination that the blower 402 has output a threshold volume of air into the expandable member 406, etc.

[0072] Each of the expandable members 406 may include an interior volume that may be defined by the flexible material 204 and may be expanded by the introduction of air through the channel 404. In some examples, each of the expandable members 406 may be disposed between two or more layers of flexible material 204 within a region within the wearable component 106. In some examples, the expandable member 406 may be at least partially permeable or semi-permeable, and the blower 402 may continue to output air to the expandable member 406 to maintain the expandable member 406 in the expanded configuration. After the blower 402 is turned off, the expandable member 406 may automatically transform back to the collapsed configuration by the diffusion of air from the interior volume of the expandable member 406. In some examples, the blower 402 may draw air from the interior volume of the expandable member 406 through the channel 404 to transform the expandable member 406 from the expanded configuration to the collapsed configuration.

[0073] Each of the expandable members 406 may be positioned below or otherwise adjacent to one or more of the electrodes 210. In some examples, as shown in FIGS. 4A and 4B , the electrically active portion of the flexible material 204 (e.g., the electrically active portion of the flexible material 204 defining the electrode 210) may at least partially define the interior volume of the expandable member 406. In other examples, the electrode 210 may be positioned on top of the expandable member 406, on the rear surface 214 of the wearable component 106. When expanded, the expandable member 406 increases the force applied by the wearable component 106 to the patient 102 (e.g., toward the torso 103 of the patient 102), thereby increasing the contact force between the electrode 210 and the skin of the patient 102 (e.g., to improve the sensing capability of the electrode 210).

[0074] FIG. 5 is a functional block diagram illustrating an exemplary configuration of the computing device 108 of FIG. 1. In the example shown in FIG. 5, the computing device 108 includes a switching circuit 502, a sensing circuit 504, a processing circuit 506, a communication circuit 508, a blower 402, a memory 510, and a power source 306. In some examples, the computing device 108 may not include the blower 402 and / or may be electrically connected to a blower 402 disposed within the wearable component 106. The various circuits may be or include programmable or fixed-function circuits configured to perform the functions attributed to the respective circuits. The memory 510 may store computer-readable instructions that, when executed by the processing circuit 506, cause the computing device 108 to perform various functions. The memory 510 may be a storage device or other non-transitory medium. The components of the computing device 108 shown in FIG. 5 may be housed within a housing of the computing device 108 (e.g., as formed by the front housing 302 and the back housing 313).

[0075] The switching circuit 502 is coupled to the electrodes 210A-210N via conductors 503A-503N (collectively "conductors 503"). The switching circuit 502 may include one or more switch arrays, one or more multiplexers, one or more switches (e.g., a switch matrix of other collections of switches), one or more transistors, or other electrical circuits. The switching circuit 502 is configured to direct electrical signals from the electrodes 210 to the sensing circuit 504, for example, to sense electrical signals from the heart of the patient 102 via a selected combination of the electrodes 210. In some examples, the switching circuit 502 may be further coupled to additional sensors (e.g., strain gauges 206, capacitors) on the wearable component 106 via one or more of the conductors 502. The switching circuit 502 may be configured to direct sensed signals from the additional sensors to the sensing circuit 504, for example, to determine one or more physiological signals (e.g., respiratory signals) and / or physiological parameters (e.g., respiration rate) of the patient 102 via the additional sensors on the wearable component 106. The physiological signals and / or physiological parameters may include, but are not limited to, the respiratory signals of the patient 102. In some examples, one or more of the additional sensors may be defined by two or more of the electrodes 210, and the switching circuit 520 may direct sensed signals from the two or more electrodes 210 to the sensing circuit 504 to determine the physiological signals and / or physiological parameters.

[0076] The sensing circuit 504 may include filters, amplifiers (e.g., sense amplifiers), analog-to-digital converters, capacitors, or other circuitry configured to sense electrical signals and convert the sensed electrical signals into ECG signals, physiological signals, and / or physiological parameters via the electrodes 210 and / or additional sensors (e.g., strain gauges 206) on the wearable component 106. In some examples, the sensing circuit 504 may include two or more sensing modules 320 (e.g., as shown in FIG. 3D ), each configured to be coupled to one or more of the electrodes 210 and / or additional sensors. In some examples, the sensing circuit 504 may include a single sensing module 320 configured to be coupled to at least some of the electrodes 210 and / or additional sensors. The sensing circuit 504 may sense and record ECG signals from the electrodes 210 and / or sensors on the wearable component 106. In some examples, the ECG signals from the electrodes 210 represent electrical activity of the patient's 102's heart (e.g., depolarization of the heart chambers). In some examples, the electrical signals from the additional sensors and / or electrodes 210 configured to be additional sensors may correspond to physiological signals and / or physiological parameters of the patient 102. The sensing circuit 504 may store the physiological signals and / or physiological parameters in the memory 510.

[0077] The processing circuitry 506 may include any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), a discrete logic circuit, or any other processing circuitry configured to provide the functionality attributed to the processing circuitry 506 herein, and may be embodied as firmware, hardware, software, or any combination thereof.

[0078] The processing circuit 506 may determine that the patient 102 is experiencing a cardiac symptom (e.g., arrhythmia, tachycardia) based on the sensed ECG signals from the heart. The processing circuit 506 may compare one or more characteristics of the sensed ECG signals to threshold conditions and determine that the patient 102 is experiencing a cardiac symptom based on a determination that at least one of the characteristics of the sensed ECG signals satisfies the threshold condition corresponding to the cardiac symptom. The one or more characteristics of the sensed ECG signals may include, but are not limited to, the amplitude of the sensed ECG signal, the frequency of the sensed ECG signal, the morphology of the sensed ECG signal, changes in the amplitude frequency and / or morphology of the sensed ECG signal, the rate of change of the amplitude, frequency and / or morphology of the sensed ECG signal, the RR interval (heart rate) or other interval between waves of the ECG signal, the variability of such intervals, the morphology or variability of such wave morphology, or any other characteristic that can be used as an indicator for detecting and / or predicting one or more cardiac symptoms. In some examples, based on a determination that patient 102 is experiencing, has experienced, or will experience within a threshold period (e.g., days, weeks, months) a cardiac symptom (e.g., an arrhythmia or heart failure event), processing circuit 506 may cause communications circuit 508 to transmit the sensed ECG signal to one or more of external device 110, network 112, and / or computing device 114. In some examples, processing circuit 506 may detect the occurrence of other instances of arrhythmia or cardiac symptom, store ECG and / or other data corresponding to the instances, and transmit the data to one or more of external device 110, network 112, and / or computing device 114.

[0079] The processing circuit 506 may determine whether the patient 102 is properly wearing the wearable component 106 based on sensed signals from the electrodes 210 and / or additional sensors. If the patient 102 is improperly wearing the wearable component 106, one or more of the electrodes 210 may be mispositioned on the patient's 102's torso 103, which may cause the sensing circuit 504 to sense inaccurate, altered, and / or distorted ECG signals from the patient's 102's heart. In some examples, the wearable component 106 may be too loose around the torso 103, leading to improper contact between the torso 103 and one or more of the electrodes 210. The improper contact may also cause the sensing circuit 504 to sense inaccurate, altered, and / or distorted ECG signals. The processing circuit 506 may determine that the wearable component 106 is improperly worn based on noise signals in the sensed signals (e.g., sensed ECG signals, sensed respiratory signals) from the wearable component 106 and may discontinue sensing of the ECG signals from the patient 102, for example, to preserve the power duration and / or memory of the computing device 108 and / or to increase the accuracy of determining any cardiac symptoms experienced by the patient 102.

[0080] In some examples, the processing circuit 506 may determine a respiratory signal and / or an ECG signal of the patient 102 from the sensed signals and determine a noise signal in the respiratory signal and / or the ECG signal. The processing circuit 506 may then determine that the wearable component 106 is improperly worn, for example, based on a determination that one or more characteristics of the determined noise signal meet a threshold noise condition. The one or more characteristics may include, but are not limited to, the amplitude of the noise signal, the frequency of the noise signal, the amplitude of the noise signal relative to the amplitude of the respiratory signal and / or the amplitude of the ECG signal, the rate and / or slope of change of the noise signal, the number of changes in the noise signal over a period of time, the amplitude of the noise signal at a particular frequency and / or frequency range, etc. The threshold noise condition may be predetermined or may be based on previously sensed information from the patient 102 and / or previously sensed information from other patients.

[0081] The processing circuit 506 may determine a respiratory signal of the patient 102 based on the voltage output by the strain gauge 206 and / or the change in capacitance between two or more electrodes 210. The processing circuit 506 may convert the sensed voltage and / or sensed capacitance into a respiratory signal and corresponding respiratory rate of the patient 102. In some examples, other physiological signals and / or parameters may be used by the processing circuit 506 to determine the respiratory signal.

[0082] In some examples, the processing circuit 506 may determine that the wearable component 106 is improperly worn by the patient 102 based on a noise signal in one of the respiratory signal or the ECG signal. In some examples, the processing circuit 506 may determine that the wearable component 106 is improperly worn based on a noise signal in one of the respiratory signal or the ECG signal and verify the determination based on a noise signal in the other of the respiratory signal or the ECG signal.

[0083] Based on a determination that the wearable component 106 is improperly worn by the patient 102, the processing circuit 506 may cause the sensing circuit 504 to discontinue sensing ECG signals from the heart of the patient 102. The processing circuit 506 may discontinue sensing ECG signals to reduce power consumption of the computing device 108 when the wearable component 106 is improperly worn. In some examples, the processing circuit 506 may discontinue sensing ECG signals to prevent storage of inaccurate electrical signals in the memory 510.

[0084] The processing circuit 506 may temporarily or permanently suspend sensing of ECG signals. In some examples, the processing circuit 506 may cause the sensing circuit 504 to suspend sensing of ECG signals, e.g., for a threshold period of time, until the processing circuit 506 receives user input (e.g., from the external device 110, the network 112, the computing device 114), or until the processing circuit 506 determines, e.g., that the noise signal no longer meets a threshold noise condition. In some examples, the processing circuit 506 may power down and / or enter a suspension mode in response to determining that the wearable component 106 is improperly owned. The path 506 may instruct a signal generating circuit (not shown) of the computing device 108 to send an electrical signal to the sensing circuit 504 (e.g., to a sense amplifier of the sensing circuit 504) to saturate the sensing circuit 504, for example, to prevent sensing of cardiac ECG signals via the electrodes 210. In some examples, the sensing circuit 504 may cease sensing ECG signals from the heart of the patient 102 while continuing to sense signals from one or more additional sensors of the wearable component 106, for example, to determine physiological signals and / or parameters of the patient 102.

[0085] In some examples, based on a determination that the wearable component 106 is improperly worn by the patient 102, the processing circuit 506 may send a command to the blower 402 to cause the blower 402 to expand at least some of the expandable members 406, e.g., to increase contact between the electrodes 210 and the patient 102 and improve the sensing sensitivity and / or accuracy of the electrodes 210. In some examples, the processing circuit 506 may determine a position and / or orientation of the wearable component 106 relative to the patient 102 (e.g., relative to the torso 103) (e.g., based on noise signals in sensing signals from multiple sensors positioned at different positions and / or orientations within the wearable component 106). The processing circuit 506 may determine which expandable members 406 to expand based on the determined position and / or orientation of the wearable component 106, and may cause the blower 402 to selectively expand one or more of the expandable members 406 to improve the sensing sensitivity and / or accuracy of some of the electrodes 210. In some examples, the processing circuit 506 may encase the blower 402 to expand all of the expandable members 406.

[0086] In some examples, the processing circuit 506 is configured to determine one or more activity states of the patient 102 based on sensed signals (e.g., from the electrodes 210, the strain gauges 206, and / or an accelerometer disposed within the ECM system 104). The sensed signals may include, but are not limited to, a signal indicative of the heart rate of the patient 102, a signal indicative of the pulse rate of the patient 102, a respiratory signal from the patient 102, a blood oxygen saturation level of the patient 102, and / or an acceleration of one or more regions of the patient 102 (e.g., detected by an accelerometer within the ECM system 104). For each activity state, the processing circuit 506 may determine a type of activity state and / or a duration of the activity state. The processing circuit 506 may define a neuromorphic architecture. The processing circuit 506 may retrieve instructions from the memory 510 and apply a machine learning algorithm (e.g., via the neuromorphic architecture) based on the retrieved instructions to determine the one or more activity states.

[0087] The processing circuit 506 may store the determined activity state of the patient 102 in the memory 510. The processing circuit 506, the external device 110, and / or the computing device 114 may determine trends and / or changes in the activity state of the patient 102 over time based on the determined activity state.

[0088] In some examples, based on a determination that the wearable component 106 is being worn improperly by the patient 102, the processing circuit 506 sends a notification via the communication circuit 508 to the external device 110, the network 112, and / or the computing device 114 indicating that the wearable component 106 is improperly positioned and prompting the patient 102 and / or one or more other individuals to reposition the wearable component 106 on the patient 102.

[0089] The communications circuitry 508 (also referred to as “telemetry circuitry 508”) supports wireless communications between the computing device 108 and the external device 110 and / or the network 112. The processing circuitry 506 may provide collected data (e.g., sensed ECG signals, respiratory signals of the patient 102, respiratory rate of the patient 102) to the external device 110, the network 112, and / or the computing device 114 via the communications circuitry 508. The communications circuitry 508 may receive user input from the external device 110 and / or the network 112 and transmit the received user input to the processing circuitry 506. The communications circuitry 508 may achieve communications via radio frequency (RF) communications techniques, for example, via an antenna (not shown). For example, the communications circuitry 508 may include a wireless transceiver configured to communicate according to a standard or protocol such as 3G, 4G, 5G, Wi-Fi (e.g., 802.11 or 802.15 ZigBee), Bluetooth®, or Bluetooth® Low Energy (BLE).

[0090] In some examples, the components of computing device 108 may include computing components of a Reveal LINQ™ or LINQ II™ cardiac monitor available from Medtronic Ltd. of Dublin, Ireland. In such examples, computing device 108 may be capable of communicating with a network 112, such as the CareLink™ network available from Medtronic Ltd. of Dublin, Ireland, for example, to detect cardiac symptoms, store sensed signals, and transmit information about the sensed signals and / or detected cardiac symptoms across multiple computing devices.

[0091] FIG. 6 is a conceptual diagram illustrating an example medical device system 600 including an ECM system 104 and one or more external monitoring devices. As shown in FIG. 6 and described previously herein, the ECM system 104 is worn around the torso 103 of the patient 102. The one or more external monitoring devices may communicate with the computing device 108 of the ECM system 104 and may transmit information sensed by the one or more external monitoring devices to the ECM system 104. The one or more external monitoring devices may include, but are not limited to, wearable sleeves 602A-602B (collectively "wearable sleeves 602") or wrist monitors 604A-604B (collectively "wrist monitors 604"). The one or more external monitoring devices are described below primarily with reference to the wearable sleeves 602 and wrist monitors 604, although the example processes described herein may also apply to other wearable monitoring devices.

[0092] The wearable sleeves 602 can be worn around the arms of the patient 102 and can sense one or more signals from the patient 102. The wearable sleeves 602 can be formed from a flexible material (e.g., flexible material 204). In some examples, the flexible material 204 is an electrically conductive fabric defining one or more electrodes configured to sense signals from the arms of the patient 102. In some examples, each of the wearable sleeves 602 includes one or more electrodes disposed within the flexible material 204. Each of the wearable sleeves 602 can include additional sensors (e.g., strain gauges, accelerometers) configured to sense signals from the arms of the patient 102, for example, to measure bioelectrical impedance (e.g., to determine the occurrence of fluid retention (e.g., edema)), monitor the blood pressure of the patient 102, etc. The patient 102 can wear one or more wearable sleeves 602 around each arm, for example, at one or more locations along the arms.

[0093] The wrist monitors 604 may be worn around the wrist of the patient 102. Each of the wrist monitors 604 may sense one or more signals from the patient 102, including, but not limited to, the oxygen saturation of the patient 102. In some examples, the wrist monitors 604 may be wrist-worn plethysmography devices.

[0094] Each of the wearable sleeve 602 and the wrist monitor 604 may be in wired or wireless communication with the ECM system 104 (e.g., with the computing device 108). In some examples, each of the wearable sleeve 602 and the wrist monitor 604 includes a power source (e.g., a removable and / or rechargeable power source) and computing circuitry configured to sense electrical signals from the patient 102. The ECM system 104 may determine whether the patient 102 is experiencing a cardiac symptom and / or other health symptom based at least in part on the sensed signals from the wearable sleeve 602 and the wrist monitor 604.

[0095] 7A is a flow diagram illustrating an exemplary method of sensing signals from a patient using the exemplary medical device system 100. While the exemplary method shown in FIG. 7A is primarily described as sensing ECG signals from the patient 102, the system 100 may apply the exemplary methods described herein to sense other electrical signals from the heart of the patient 102. While FIG. 7A illustrates the use of voltage from a strain gauge 206 to determine a respiratory signal of the patient 102, other exemplary sensed signals from the patient 102 (e.g., a change in capacitance from two or more of the electrodes 210 configured to be a capacitor and / or two or more capacitors) may be used to determine a respiratory signal.

[0096] A computing device 108 of the ECM system 104 may sense ECG signals from one or more electrodes 210 on the wearable component 106 (702). The electrodes 210 may be disposed on a rear surface 214 of the wearable component 106 or may be defined by an electrically conductive (e.g., dry electrode) flexible material 204. The computing device 108 may be configured to be removably secured to the wearable component 106 (e.g., within a recess 202 of the wearable component 106) and electrically connected to the electrodes 210. The computing device 108 senses ECG signals from the patient 102 via the electrodes 210. The ECG signals correspond to the electrical activity of the patient's 102's heart. The computing device 108 may store the sensed ECG signals in memory 510 of the computing device 108. The computing device 108 may transmit the sensed ECG signals to an external device 110, a network 112, and / or a computing device 114 of the system 100.

[0097] In some examples, the computing device 108 determines whether the patient 102 is experiencing, has experienced, or will experience a cardiac symptom based on the sensed ECG signal. The computing device 108 may determine whether one or more characteristics (e.g., amplitude, frequency, rate of change) of the sensed ECG signal satisfy a threshold condition and determine that the patient 102 is experiencing, has experienced, or will experience a cardiac symptom based on the satisfaction of the threshold condition. In some examples, the computing device 108 may transmit the sensed ECG signal to the external device 110, the network 112, and / or the computing device 114 based on the satisfaction of the threshold condition.

[0098] The computing device 108 may sense (704) a change in voltage generated by the strain gauges 206 on the wearable component 106 when the torso 103 of the patient 102 expands and contracts in response to the patient's 102's breathing, applying strain or stress to the strain gauges 206 disposed on the wearable component 106 along the longitudinal axis 205 of the wearable component 106. The applied strain or stress causes the strain gauges 206 to elongate or compress, generating a voltage. The computing device 108 may be electrically connected to the strain gauges 206 and may sense the change in voltage generated by the strain gauges 206. The computing device 108 may obtain (706) a respiration rate (RR) and a respiration signal from the change in voltage. The computing device 108 may filter and / or convert the sensed change in voltage into a respiration signal. The computing device 108 may determine the respiration rate of the patient 102 based on the respiration signal over a set period of time. In some examples, the computing device 108 may output the determined RR and / or respiration signal to the external device 110, the network 112, and / or the computing device 114.

[0099] The computing device 108 may determine whether there is a noise signal in the respiratory signal (708). Based on a determination that there is no noise signal in the respiratory signal (the "No" branch of 708), the computing device 108 may continue to sense an ECG signal via one or more of the electrodes 210 (714).

[0100] Based on a determination that there is a noise signal in the respiratory signal ("Yes" branch of 708), the computing device 108 may determine whether the noise signal meets a threshold noise condition (710). The computing device 108 may determine whether the noise signal meets a threshold noise condition by determining whether one or more characteristics of the noise signal meet the threshold noise condition. The one or more characteristics may include, but are not limited to, the amplitude of the noise signal, the frequency of the noise signal, the amplitude of the noise signal relative to the amplitude of the respiratory signal and / or the amplitude of the ECG signal, the rate and / or slope of change of the noise signal, the number of changes in the noise signal over a period of time, the amplitude of the noise signal at a particular frequency and / or range of frequencies, etc.

[0101] Based on a determination that the noise signal does not meet the threshold noise condition (the "no" branch of 710), the computing device 108 may continue to sense ECG signals via one or more of the electrodes 210 (714). Based on a determination that the noise signal meets the threshold noise condition (the "yes" branch of 710), the computing device 108 discontinues sensing ECG signals via one or more of the electrodes 210 (712).

[0102] The computing device 108 may suspend sensing of ECG signals to, for example, reduce power consumption, prevent storage of inaccurate ECG signals, and / or increase the accuracy of determining a cardiac symptom experienced by the patient 102. The computing device 108 may suspend sensing of ECG signals by saturating one or more sense amplifiers of the computing device 108. In some examples, the computing device 108 may power down to suspend sensing of ECG signals. The computing device 108 may temporarily suspend sensing of ECG signals. In some examples, the computing device 108 may resume sensing ECG signals based on receipt of user input, after a predetermined period of time, and / or based on a determination by the computing device 108 that a noise signal in the respiratory signal no longer meets a threshold noise condition.

[0103] 7B is a flow diagram illustrating an exemplary method for expanding the expandable member 406 of the exemplary medical device system 100. The computing device 108 of the ECM system 104 may perform steps 702-710 and 714 according to the exemplary method described with respect to FIG.

[0104] 7B , based on a determination that the noise signal meets the threshold noise condition (“Yes” step of 710), the computing device 108 may expand the expandable member 406 via the blower 402 (e.g., within the computing device 108). The expandable member 406 is disposed within the wearable component 106 and / or defined by the flexible material 204 of the wearable component 106. The expansion of the expandable member 406 may increase the contact force between the electrode 210 and the skin of the patient 102, for example, increasing the sensing sensitivity and / or sensing accuracy of the electrode 210. The blower 402 may output air into the expandable member 406 through the channel 404 to expand the expandable member 406 to the expanded configuration. In some examples, the blower 402 may continue to output air into the expandable member 406 to maintain the expandable member 406 in the expanded configuration.

[0105] The computing device 108 may continue to sense the ECG signal via the one or more electrodes (714). In some examples, the computing device 108 may continue to sense the ECG signal for a set period of time and determine whether the expansion of the expandable member 406 reduces the noise signal of the respiratory signal such that the noise signal no longer meets a threshold noise condition (e.g., a characteristic of the noise signal no longer meets a threshold condition). Based on a determination that the noise signal continues to meet the threshold condition, the computing device 108 may discontinue sensing the ECG signal, for example, according to step 712 of the example method of FIG. 6A .

[0106] In some examples, the computing device 108 may expand the expandable member 406 via the blower 402 based on a determination that the noise signal meets a threshold noise condition by a threshold amount (e.g., corresponding to a minor loss of contact). In such examples, expansion of the expandable member 406 increases contact between the electrodes 210 and the skin of the patient 102 and mitigates the minor loss of contact. In some examples, the computing device 108 may determine that the noise signal exceeds the threshold noise condition by a threshold amount, for example, corresponding to a total loss of contact. In such examples, expansion of the expandable member 406 does not mitigate the total loss of contact, and the computing device 108 proceeds directly to discontinuing sensing of the ECG signal without expanding the expandable member 406.

[0107] 8 is a flow diagram illustrating another exemplary method for sensing electrical signals from a patient 102 using the exemplary medical device system 100. The system 100 may apply the exemplary method of FIG. 8 to sense electrical signals from the heart of the patient 102 and / or to determine whether the wearable component 106 of the ECM system 104 of the system 100 is properly worn by the patient 102.

[0108] The computing device 108 may acquire 802 an ECG signal of the patient 102 via one or more electrodes 210 on the wearable component 106. The electrodes 210 are placed in contact with the patient 102 and electrically connected to the computing device 108 (e.g., via an electrically conductive (e.g., dry electrode) flexible material 204). The electrodes 210 may be configured to detect signals corresponding to electrical activity of the patient's 102's heart and filter the acquired signals to determine an ECG signal. The ECG signal corresponds to the heart's electrical activity and may be used by the computing device 108 to determine whether the patient 102 is experiencing, has experienced, and / or will experience a cardiac symptom. The computing device 108 may store the sensed ECG signal and / or transmit the ECG signal to an external device 110, a network 112, and / or a computing device 114. In some examples, the computing device 108 may determine, based on the sensed ECG signal, whether the patient 102 has experienced, is experiencing, or will experience a cardiac symptom, for example, according to the exemplary methods described above.

[0109] The computing device 108 may determine whether there is a noise signal in the ECG signal (804). Based on a determination that there is no noise signal in the ECG signal (the "no" branch of 804), the computing device 108 may continue to sense the ECG signal via one or more electrodes 210 (810). Based on a determination that there is a noise signal in the ECG signal (the "yes" branch of 804), the computing device 108 determines whether the noise signal in the ECG signal meets a threshold noise condition (806).

[0110] The computing device 108 may determine whether a noise signal in the ECG signal satisfies one or more threshold noise conditions, for example, according to one or more exemplary methods such as those described above. Based on a determination that the noise signal does not satisfy the threshold noise condition (the “no” branch of 806), the computing device 108 may continue sensing the ECG signal via one or more electrodes 210 (810). Based on a determination that the noise signal satisfies the threshold noise condition (the “yes” branch of 806), the computing device 108 may discontinue sensing the ECG signal via one or more electrodes 210 (808). In some examples, based on a determination that the noise signal satisfies the threshold noise condition, the computing device 108 may expand the expandable member 406, for example, according to the exemplary method described in FIG. 6B .

[0111] In some examples, the medical device system 100 may determine whether the wearable component 106 is properly worn by the patient 102 by applying the example method shown in either Figure 7A or Figure 8. In some examples, the medical device system 100 may determine whether the wearable component 106 is properly worn by the patient 102 by applying the example method of Figures 7A and 8, and / or may apply one of the example methods of Figures 7A and 8 to verify a determination made by applying the other example method of Figures 7A and 8.

[0112] The disclosed devices, systems, and techniques offer improvements over other medical therapy delivery systems. Establishing a connection between an external device and an implanted device prior to delivery of a medical therapy ensures the availability of external assistance in the event of an unintended event, thereby reducing the severity of the impact of any such unintended event. In some examples, using contextual factors to select a medical therapy based on the aggressiveness of each medical therapy may increase the accuracy of tachyarrhythmia prediction, reduce the severity of the impact of an unintended event occurrence, and / or increase the effectiveness of medical therapy while reducing the risk of an unintended event.

[0113] The techniques of this disclosure may be implemented in a wide variety of computing devices, medical devices, or any combination thereof. Any of the described units, modules, or components may be implemented together or separately as discrete but interoperable logical devices. The depiction of different features as modules or units is intended to emphasize different functional aspects and does not necessarily imply that such modules or units must be realized by separate hardware or software components. Rather, the functionality associated with one or more modules or units may be performed by separate hardware or software components or may be integrated within a common or separate hardware or software component.

[0114] This disclosure contemplates a computer-readable storage medium comprising instructions that cause a processor to perform any of the functions and techniques described herein. The computer-readable storage medium may take the exemplary form of any volatile, non-volatile, magnetic, optical, or electrical medium, such as RAM, ROM, NVRAM, EEPROM, or flash memory that is tangible. The computer-readable storage medium may be referred to as non-transitory. A server, client computing device, or any other computing device may also include more portable, removable memory types to allow for easy data transfer or offline data analysis.

[0115] The techniques described in this disclosure, including those resulting from various modules and constituent components, may be implemented, at least in part, in hardware, software, firmware, or any combination thereof. For example, various aspects of the techniques may be implemented within one or more processors, including one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, or other processing circuitry, as well as any combination of such components, remote servers, remote client devices, or other devices. The terms "processor" or "processing circuitry" may generally refer to any of the foregoing logic circuitry, alone or in combination with other logic circuitry or any other equivalent circuitry.

[0116] Such hardware, software, and firmware may be implemented within the same device or within separate devices to support the various operations and functions described in this disclosure. Additionally, any of the described units, modules, or components may be implemented together or separately as discrete but interoperable logic devices. The depiction of different features as modules or units is intended to emphasize different functional aspects and does not necessarily imply that such modules or units must be realized by separate hardware or software components. Rather, the functionality associated with one or more modules or units may be performed by separate hardware or software components or may be integrated within common or separate hardware or software components. For example, any module described herein may include electrical circuitry configured to perform the features attributed to that particular module, such as a fixed-function processing circuit, a programmable processing circuit, or a combination thereof.

[0117] The techniques described in this disclosure may also be embodied in or coded in an article of manufacture including a computer-readable storage medium encoded with instructions. The instructions embedded or coded in the article of manufacture including the coded computer-readable storage medium may cause one or more programmable processors or other processors to perform one or more of the techniques described herein, such as when the instructions contained in or coded on the computer-readable storage medium are executed by the one or more processors. Exemplary computer-readable storage media may include random access memory (RAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electronically erasable programmable read-only memory (EEPROM), flash memory, hard disk, compact disc ROM (CD-ROM), floppy disk, cassette, magnetic medium, optical medium, or any other computer-readable storage device or tangible computer-readable medium. A computer-readable storage medium may also be referred to as a storage device.

[0118] In some examples, a computer-readable storage medium comprises a non-transitory medium. The term "non-transitory" may indicate that the storage medium is not embodied in a carrier wave or propagated signal. In particular examples, a non-transitory storage medium may store data that can change over time (e.g., in RAM or cache).

[0119] It should be noted that the medical device system 100 and the techniques described herein may not be limited to use with human patients. Alternatively, the medical device system 100 may be implemented in non-human patients, such as primates, canines, equines, porcines, felines, ursinians, pachyderms, and penguins. These other animals may undergo clinical or research treatments that would benefit from the subject matter of the present disclosure. Various examples are described herein, such as the following examples.

[0120] Example 1: A medical device system, the medical device system comprising: a wearable component configured to surround a portion of a patient's torso, the wearable component defining a longitudinal axis, the wearable component comprising: an electrically conductive fabric; a plurality of electrically active regions defined by the electrically conductive fabric and disposed along the longitudinal axis of the electrically conductive fabric, each of the plurality of electrically active regions configured to contact the patient's skin and sense an electrocardiogram (ECG) signal of the patient's heart; one or more strain gauges disposed along the longitudinal axis within the electrically conductive fabric; and a recess; and a computing module disposed within the recess; 1. A medical device system comprising: a computing module comprising: a sensing circuit electrically connected to a plurality of electrically active areas and one or more strain gauges; and a processing circuit configured to: cause the sensing circuit to sense ECG signals via the plurality of electrically active areas and measure voltage values ​​from the one or more strain gauges over time; determine a respiratory signal of the patient and a noise signal within the respiratory signal based on the voltage values; determine whether the noise signal within the respiratory signal satisfies a threshold condition; and cause the sensing circuit to discontinue sensing of the ECG signal based on a determination that the noise signal satisfies the threshold condition.

[0121] Example 2: The medical device system of Example 1, wherein the sensing circuit includes one or more sense amplifiers, and the processing circuit is configured to send a signal to the sensing circuit to saturate the one or more sense amplifiers to cause the sensing circuit to discontinue sensing the ECG signal.

[0122] Example 3: The medical device system of Example 1, wherein the processing circuitry is configured to power down the computing module in response to determining that the noise signal satisfies a threshold condition to cause the sensing circuitry to discontinue sensing the ECG signal.

[0123] Example 4: The medical device system of any of Examples 1-3, wherein the processing circuitry is configured to cause the sensing circuitry to suspend sensing of ECG signals for a predetermined period of time.

[0124] Example 5: The medical device system of any of Examples 1-4, wherein the processing circuitry is configured to cause the sensing circuitry to suspend sensing of the ECG signal until the processing circuitry determines that a noise signal in the respiratory signal no longer satisfies a threshold condition.

[0125] Example 6: The medical device system of any of Examples 1 to 5, wherein the wearable component comprises one or more expandable members in fluid communication with the recess, and the computing module further comprises a blower configured to expand the one or more expandable members, wherein when expanded, the one or more expandable members are configured to increase the contact force between the skin and at least one of the plurality of electrically active regions.

[0126] Example 7: The medical device system of Example 6, wherein the processing circuitry is further configured to cause the blower to expand the one or more expandable members based on a determination that the noise signal satisfies a threshold condition.

[0127] Example 8: The medical device system of any of Examples 1-7, wherein the computing module is removably secured within the recess.

[0128] Example 9: The medical device system of Example 8, wherein the computing module is removably secured within the recess via a securing mechanism, and the sensing circuit of the computing module is electrically connected to the electrically active area and one or more strain gauges via the securing mechanism.

[0129] Example 10: The medical device system of Example 9, wherein the fixation mechanism comprises a plurality of spring clips.

[0130] Example 11: The medical device system of any of Examples 1-10, wherein the electrically conductive fabric comprises a dry electrode material that defines a plurality of electrically active areas.

[0131] Example 12: The medical device system of any of Examples 1 to 11, wherein the computing module further comprises a removable power supply.

[0132] Example 13: The medical device system of any of Examples 1 to 12, wherein the threshold condition includes a threshold noise signal amplitude, and the processing circuitry is configured to determine that the noise signal satisfies the threshold condition based on a determination that the amplitude of the noise signal is greater than or equal to the threshold noise signal amplitude.

[0133] Example 14: The medical device system of any of Examples 1-13, wherein the noise signal satisfies the threshold condition when the wearable component is not in a predetermined position about the patient's torso.

[0134] Example 15: The medical device system of Example 14, wherein the computing module comprises a communication circuit, and the processing circuit is configured to transmit the sensed ECG signal to one or more external computing devices or computing networks via the communication circuit.

[0135] Example 16: The medical device system of Example 15, wherein the processing circuitry is configured to determine whether the patient is experiencing arrhythmia based on the sensed ECG signal, and to transmit the sensed ECG signal via the communication circuitry to one or more external computing devices or computing networks based on a determination that the patient is experiencing arrhythmia.

[0136] Example 17: A medical device system comprising: a wearable component configured to surround a portion of a patient's torso, the wearable component defining a longitudinal axis and comprising: an electrically conductive fabric; a plurality of electrically active areas defined by the electrically conductive fabric and arranged along the longitudinal axis of the electrically conductive fabric, each of the plurality of electrically active areas configured to contact the patient's skin and sense electrocardiogram (ECG) signals of the patient's heart; and a recess; and a computing module disposed within the recess, the computing module comprising: a sensing circuit electrically connected to the plurality of electrically active areas; and a processing circuit configured to: cause the sensing circuit to sense ECG signals via the plurality of electrically active areas; determine a noise signal in the sensed ECG signals; determine whether the noise signal satisfies a threshold condition; and cause the sensing circuit to discontinue sensing the ECG signals based on a determination that the noise signal satisfies the threshold condition.

[0137] Example 18: The medical device system of Example 17, wherein the sensing circuit includes one or more sense amplifiers, and the processing circuit is configured to send a signal to the sensing circuit to saturate the one or more sense amplifiers to cause the sensing circuit to discontinue sensing the ECG signal.

[0138] Example 19: The medical device system of Example 17, wherein the processing circuit is configured to power down the computing module in response to determining that the noise signal satisfies a threshold condition to cause the sensing circuit to discontinue sensing the ECG signal.

[0139] Example 20: The medical device system of any of Examples 17-19, wherein the processing circuitry is configured to cause the sensing circuitry to suspend sensing of ECG signals for a predetermined period of time.

[0140] Example 21: The medical device system of any of Examples 17-20, wherein the processing circuit is configured to cause the sensing circuit to suspend sensing of the ECG signal until the processing circuit determines that the noise signal no longer satisfies the threshold condition.

[0141] Example 22: The medical device system of any of Examples 17 to 21, wherein the wearable component comprises one or more expandable members in fluid communication with the recess, and the computing module further comprises a blower configured to expand the one or more expandable members, wherein when expanded, the one or more expandable members are configured to increase the contact force between the skin and at least one of the plurality of electrically active areas.

[0142] Example 23: The medical device system of Example 22, wherein the processing circuitry is further configured to cause the blower to expand the one or more expandable members based on a determination that the noise signal satisfies a threshold condition.

[0143] Example 24: The medical device system of any of Examples 17 to 23, wherein the computing module is fixed within the recess and is removable.

[0144] Example 25: The medical device system of Example 24, wherein the computing module is removably secured within the recess via a securing mechanism, and the sensing circuit of the computing module is electrically connected to the electrically active area via the securing mechanism.

[0145] Example 26: The medical device system of Example 25, wherein the fixation mechanism comprises a plurality of spring clips.

[0146] Example 27: The medical device system of any of Examples 17-26, wherein the electrically conductive fabric comprises a dry electrode material that defines a plurality of electrically active areas.

[0147] Example 28: The medical device system of any of Examples 17 to 27, wherein the computing module further comprises a removable power supply.

[0148] Example 29: The medical device system of any of Examples 17 to 28, wherein the threshold condition includes a threshold noise signal amplitude, and the processing circuit is configured to determine that the noise signal satisfies the threshold condition based on a determination that the amplitude of the noise signal is greater than or equal to the threshold noise signal amplitude.

[0149] Example 30: The medical device system of any of Examples 17-29, wherein the noise signal satisfies the threshold condition when the wearable component is not in a predetermined position around the patient's torso.

[0150] Example 31: The medical device system of Example 30, wherein the computing module comprises a communication circuit, and the processing circuit is configured to transmit the sensed ECG signal to one or more external computing devices or computing networks via the communication circuit.

[0151] Example 32: The medical device system of Example 31, wherein the processing circuitry is configured to determine whether the patient is experiencing arrhythmia based on the sensed ECG signal, and to transmit the sensed ECG signal via the communication circuitry to one or more external computing devices or computing networks based on a determination that the patient is experiencing arrhythmia.

[0152] Example 33: A computing device configured to sense electrocardiogram (ECG) signals from a patient, the computing device comprising: a sensing circuit having one or more sense amplifiers; a processing circuit configured to: sense signals from one or more sensors on a wearable component that contacts the patient's skin via the sensing circuit; determine a noise signal within the sensed signals; determine whether the noise signal meets a threshold condition; determine that the patient is improperly wearing the wearable strap based on a determination that the noise signal meets the threshold condition; and cause the sensing circuit to discontinue sensing of the ECG signals based on a determination that the patient is improperly wearing the wearable component; and a securing mechanism configured to electrically connect the computing device and the one or more sensors.

[0153] Example 34: The computing device of Example 33, wherein the one or more sensors comprise one or more strain gauges, the sensing circuitry is configured to measure voltage values ​​over time via the one or more strain gauges, and the processing circuitry is further configured to determine a respiratory signal of the patient based on the measured voltage values, wherein the sensed signal comprises a respiratory signal and the noise signal of the sensed signal comprises a noise signal of the respiratory signal.

[0154] Example 35: The computing device of Example 34, wherein the threshold condition includes a threshold noise signal amplitude, and to determine that the noise signal satisfies the threshold condition, the processing circuit is configured to determine that the amplitude of the noise signal of the respiratory signal is greater than or equal to the threshold noise signal amplitude.

[0155] Example 36: The computing device of any of Examples 33-35, wherein the one or more sensors comprise one or more electrically active areas arranged along the wearable component.

[0156] Example 37: The computing device of Example 36, wherein the processing circuit is configured to sense ECG signals from one or more electrically active regions via the sensing circuit, the sensed signals comprising ECG signals, and the noise signals of the sensed signals comprising noise signals of the ECG signals.

[0157] Example 38: The computing device of Example 37, wherein the threshold condition includes a threshold noise signal amplitude, and to determine that the noise signal satisfies the threshold condition, the processing circuit is configured to determine that the amplitude of the noise signal of the ECG signal is greater than or equal to the threshold noise signal amplitude.

[0158] Example 39: A computing device of any of Examples 36 to 38, wherein each of the one or more sense amplifiers is electrically connected to a corresponding electrically active area among the plurality of electrically active areas, and each sense amplifier of the one or more sense amplifiers is configured to sense an ECG signal from the patient's skin.

[0159] Example 40: The computing device of any of Examples 33 to 39, further comprising a blower configured to connect to one or more expandable members disposed on the wearable component, and the processing circuitry is further configured to engage the blower to expand the one or more expandable members to increase contact force between the one or more sensors and the patient based on a determination that the patient is wearing the wearable component improperly.

[0160] Example 41: The computing device of any of Examples 33-40, wherein the securing mechanism comprises one or more spring clips.

[0161] Example 42: The computing device of any of Examples 33 to 41, further comprising a removable power supply.

[0162] Example 43: A method includes sensing, by a sensing circuit of a computing module, an electrocardiogram (ECG) signal of a patient's heart via a plurality of electrically active areas disposed on a wearable component configured to be worn by the patient and to contact the patient's skin, the wearable component being configured to surround a portion of the patient's torso, the wearable component comprising an electrically conductive fabric defining a plurality of electrically active areas along a longitudinal axis of the wearable component, and a recess configured to hold the computing module; determining, by a processing circuit of the computing module, a noise signal in the ECG signal based on the ECG signal; determining, by the processing circuit, whether the noise signal satisfies a threshold condition; determining, by the processing circuit, that the patient is improperly wearing the wearable component based on a determination that the noise signal satisfies the threshold condition; and causing the sensing circuit to discontinue sensing of the ECG signal based on a determination that the patient is improperly wearing the wearable component.

[0163] Example 44: The method of Example 43, wherein determining that the noise signal satisfies the threshold condition includes determining, by the processing circuitry, that a characteristic of the noise signal is greater than or equal to a threshold corresponding to the characteristic.

[0164] Example 45: The method of any of Examples 43 and 44, wherein the sensing circuit includes a plurality of sense amplifiers, each sense amplifier of the plurality of sense amplifiers electrically connected to a corresponding electrically active area of ​​the plurality of electrically active areas, and causing the sensing circuit to discontinue sensing of the ECG signal includes sending a signal to the sensing circuit to saturate one or more sense amplifiers.

[0165] Example 46: The method of any of Examples 43-45, further comprising: determining, by the processing circuitry, an amount of time since the sensing circuitry ceased sensing ECG signals; and, based on a determination that the amount of time is equal to or greater than a predetermined period, causing the sensing circuitry to resume sensing ECG signals.

[0166] Example 47: The method of any of Examples 43 to 46, further comprising: determining, by the processing circuit, whether the noise signal satisfies a threshold condition after discontinuing sensing of the ECG signal; and, based on a determination that the noise signal no longer satisfies the threshold condition, causing the processing circuit to resume sensing of the ECG signal.

[0167] Example 48: The method of any of Examples 43 to 47, wherein the wearable component further comprises one or more strain gauges arranged along a longitudinal axis of the wearable component, and the method further includes: sensing, by a sensing circuit, voltage values ​​measured over time via the one or more strain gauges; determining, by a processing circuit, a respiratory signal of the patient based on the measured voltage values; determining, by the processing circuit, a noise signal of the respiratory signal; determining, by the processing circuit, whether the noise signal of the respiratory signal satisfies a noise signal threshold condition; and, based on a determination that the noise signal of the respiratory signal satisfies the noise signal threshold condition, causing the processing circuit to discontinue sensing of the ECG signal.

[0168] Example 49: The method of any of Examples 43 to 48, wherein causing the sensing circuit to discontinue sensing the signal includes powering off the computing module in response to the processing circuit determining that the noise signal satisfies a threshold condition.

[0169] Example 50: The method of any of Examples 43 to 49, wherein the wearable component comprises one or more expandable members in fluid communication with the recess, and when expanded, the one or more expandable members are configured to increase the contact force between the skin and at least one of the plurality of electrically active areas.

[0170] Example 51: The method of Example 50, further comprising, based on a determination that the noise signal satisfies a threshold condition, causing a blower disposed within the computing module to expand one or more expandable members by the processing circuit.

[0171] Example 52: The method of any of Examples 43 to 51, wherein the computing module is held in the recess by a fixing mechanism.

[0172] Example 53: The method of Example 52, wherein the securing mechanism comprises a plurality of spring clips.

[0173] Example 54: The method of any of Examples 43 to 53, further comprising, based on a determination that the patient is wearing the wearable component improperly, sending, by the processing circuitry, via the communication circuitry of the computing module, a notification that the patient is wearing the wearable component improperly to one or more external computing devices or computing networks.

[0174] Various embodiments of the present disclosure have been described. Any combination of the described systems, operations, or functions is contemplated. These and other embodiments are within the scope of the following claims.

Claims

1. 1. A medical device system, comprising: the medical device system comprising a wearable component configured to encircle a portion of a patient's torso, the wearable component defining a longitudinal axis; An electrically conductive fabric; a plurality of electrically active regions defined by the electrically conductive fabric and disposed along the longitudinal axis of the electrically conductive fabric, each of the plurality of electrically active regions configured to contact the patient's skin and sense an electrocardiogram (ECG) signal of the patient's heart; one or more strain gauges disposed within the electrically conductive fabric along the longitudinal axis; a wearable component comprising a recess; a computing module disposed within the recess, the computing module comprising: a sensing circuit electrically connected to the plurality of electrically active areas and the one or more strain gauges; a processing circuit, the processing circuit comprising: causing the sensing circuitry to sense the ECG signal through the plurality of electrically active regions and measure voltage values ​​from the one or more strain gauges over time; determining a respiratory signal of the patient and a noise signal within the respiratory signal based on the voltage values; determining whether the noise signal in the respiratory signal meets a threshold condition; and causing the sensing circuit to discontinue sensing the ECG signal based on a determination that the noise signal satisfies the threshold condition.

2. 10. The medical device system of claim 1, wherein the sensing circuit comprises one or more sense amplifiers, and the processing circuit is configured to send a signal to the sensing circuit to saturate the one or more sense amplifiers to cause the sensing circuit to cease sensing the ECG signal.

3. 10. The medical device system of claim 1, wherein the processing circuitry is configured to power down the computing module in response to the determination that the noise signal satisfies the threshold condition to cause the sensing circuitry to discontinue sensing the ECG signal.

4. The medical device system of any one of claims 1 to 3, wherein the processing circuitry is configured to cause the sensing circuitry to suspend sensing of the ECG signal for a predetermined period of time.

5. 5. The medical device system of claim 1, wherein the processing circuitry is configured to cause the sensing circuitry to cease sensing the ECG signal until the processing circuitry determines that the noise signal in the respiratory signal no longer satisfies the threshold condition.

6. The wearable component comprises one or more expandable members in fluid communication with the recess, and the computing module comprises:

6. The medical device system of claim 1, further comprising a blower configured to expand the one or more expandable members, wherein when expanded, the one or more expandable members are configured to increase a contact force between the skin and at least one of the plurality of electrically active regions.

7. The processing circuitry The medical device system of claim 6 , further configured to cause the blower to expand the one or more expandable members based on the determination that the noise signal satisfies the threshold condition.

8. 8. The medical device system of claim 1, wherein the computing module is removably secured within the recess via a securing mechanism, and the sensing circuit of the computing module is electrically connected to the electrically active area and the one or more strain gauges via the securing mechanism.

9. The medical device system of claim 8 , wherein the securing mechanism comprises a plurality of spring clips.

10. The medical device system of any one of claims 1 to 9, wherein the electrically conductive fabric comprises a dry electrode material that defines the plurality of electrically active areas.

11. The medical device system of any one of claims 1 to 10, wherein the computing module further comprises a removable power supply.

12. 12. The medical device system of claim 1, wherein the threshold condition includes a threshold noise signal amplitude, and the processing circuit is configured to determine that the noise signal satisfies the threshold condition based on a determination that the amplitude of the noise signal is greater than or equal to the threshold noise signal amplitude.

13. The medical device system of claim 1 , wherein the noise signal satisfies the threshold condition when the wearable component is not in a predetermined position about the patient's torso.

14. The computing module includes a communication circuit, and the processing circuit includes: The medical device system of claim 13 , configured to transmit the sensed ECG signals via the communication circuitry to one or more of an external computing device or a computing network.

15. The processing circuitry determining whether the patient is experiencing an arrhythmia based on the sensed ECG signal; and transmitting the sensed ECG signal via the communications circuitry to the one or more of the external computing device or the computing network based on a determination that the patient is experiencing the arrhythmia.

Images