Wearable optical physiological monitoring device adhesion

Abstract

The present invention relates to a non-invasive cardiac monitoring device that records cardiac data to infer a physiological characteristic of a person, such as arrhythmia or other vital signs. Some examples of the invention allow for long-term monitoring of physiological signals. Other examples allow for processing ECG data and PPG data to calculate pulse time of arrival. Some examples include a wearable cardiac monitoring device on the chest including ECG and PPG sensors for long term attachment to a mammal to detect cardiovascular signals for a long term.

Description

[0001] Incorporation by reference

[0002] This application claims priority to U.S. Provisional Application No. 63 / 423,756, filed on November 8, 2022, entitled "Electronic Components for Physiological Monitoring Devices", the entire disclosure of which is incorporated herein by reference for all purposes herein. Any applications and all applications identified in the Application Data Sheet filed with this application for domestic and foreign priority claims are incorporated herein by reference in accordance with 37 C.F.R. § 1.57 of Title 37 of the United States Code.

[0003] Background

[0004] For purposes of this invention, certain aspects, advantages, and novel features of various examples are described herein. It should be understood that not all such advantages may be achieved in any particular example. Thus, the various examples may be implemented in a manner that achieves one or a set of advantages taught herein, and not necessarily other advantages taught or implied herein. Technical Field

[0005] Materials, devices, methods, and systems for monitoring physiological signals are disclosed herein. For example, such physiological signals may include cardiac signals, such as electrocardiogram signals. Background Art

[0006] Cardiac arrhythmias or dysrhythmias can cause various symptoms, such as loss of consciousness, palpitations, dizziness, and even death. Arrhythmias that cause such symptoms are often signs of serious underlying heart disease. It is important to identify when such symptoms are due to arrhythmias, as treatment through various procedures, such as pacemaker implantation or percutaneous catheter ablation, can successfully improve these problems and prevent the occurrence of serious symptoms and death. For example, Holter monitors and similar devices are currently used to monitor heart rhythm. Summary of the Invention

[0007] The systems, methods, and devices of the present invention each have multiple innovative aspects, none of which alone determines all of the desired attributes disclosed herein. One or more implementation details of the subject matter described in this specification will be set forth in the following drawings and description.

[0008] In some aspects, the techniques described herein relate to an electronic device configured to monitor a user's physiological signals. The electronic device includes: a housing that at least partially encloses a circuit board configured to process the physiological signals to infer the user's physiological characteristics; a flexible wing extending from the housing and configured to be secured to the user's surface; and an optical sensor assembly located on the flexible wing and configured to acquire a photoplethysmography signal. The optical sensor assembly includes an optical emitter configured to emit light and an optical detector configured to receive light. At least a portion of the light emitted by the optical emitter is directed into the user's skin (e.g., the chest), and is received by the optical detector from the user's skin (e.g., the chest). The optical sensor assembly further includes a first directing layer between the optical emitter and the user's surface and a second directing layer between the optical detector and the user's surface. The first directing layer directs the light from the optical emitter to the user's surface, and the second directing layer directs the light from the user's surface to the optical detector.

[0009] In some aspects, the techniques described herein relate to an electronic device, wherein the first directing layer includes a first convex lens and the second directing layer includes a second convex lens.

[0010] In some aspects, the techniques described herein relate to an electronic device, wherein the first convex lens and the second convex lens are positioned to extend under the flexible wing such that when the electronic device is secured to the user's skin (e.g., the chest), the first convex lens and the second convex lens press into the user's skin.

[0011] In some aspects, the techniques described herein relate to an electronic device, wherein the optical sensor assembly further includes an opaque barrier located between the first directing layer and the second directing layer.

[0012] In some aspects, the techniques described herein relate to an electronic device, wherein the opaque barrier blocks at least a portion of the light emitted by the optical emitter from being received by the optical detector without passing through the user's skin (e.g., the chest).

[0013] In some aspects, the techniques described herein relate to an electronic device, wherein the opaque barrier is configured to direct at least a portion of the light from the user's surface to the optical detector.

[0014] In some aspects, the techniques described herein relate to an electronic device, which further includes a reflective layer located between the opaque barrier and the user's skin (e.g., the chest).

[0015] In some aspects, the techniques described herein relate to an electronic device, wherein the reflective layer reflects the light from the first directing layer.

[0016] In some aspects, the techniques described herein relate to an electronic device in which a first alignment layer and a second alignment layer protrude beyond a portion of an opaque barrier, overlap at least the portion of the opaque barrier, and increase the contact area with a user's skin (such as the chest).

[0017] In some aspects, the techniques described herein relate to an electronic device in which the first alignment layer and the second alignment layer are configured to direct or redirect the passage of light of a specific wavelength.

[0018] In some aspects, the techniques described herein relate to an electronic device in which the first alignment layer includes a first concave lens and the second alignment layer includes a second concave lens.

[0019] In some aspects, the techniques described herein relate to an electronic device in which the first concave lens and the second concave lens are formed of a high index material that is index-matched to the refractive index of the stratum corneum of the user's chest.

[0020] In some aspects, the techniques described herein relate to an electronic device in which the first alignment layer includes a first hemispherical lens and the second alignment layer includes a second hemispherical lens.

[0021] In some aspects, the techniques described herein relate to an electronic device in which both the first hemispherical lens and the second hemispherical lens include sapphire half ball lenses.

[0022] In some aspects, the techniques described herein relate to an electronic device that further includes a first adhesive layer configured to fix the first hemispherical lens to an optical emitter and a second adhesive layer configured to fix the second hemispherical lens to an optical detector.

[0023] In some aspects, the techniques described herein relate to an electronic device in which the circuit board includes a flexible circuit board.

[0024] In some aspects, the techniques described herein relate to an electronic device that further includes a backing substrate that applies pressure to the circuit board to increase the contact between the optical emitter and the user's skin (such as the chest), increase the contact between the optical detector and the user's skin (such as the chest), or increase the contact between the optical emitter and the user's skin (such as the chest) and between the optical detector and the user's skin (such as the chest).

[0025] In some aspects, the technology described herein relates to an electronic device, wherein an optical sensor assembly includes a plurality of optical transmitters including optical emitters, and when the flexible wings are fixed to a user surface, the plurality of optical transmitters pinch the user's skin (e.g., the skin on the chest), causing a portion of the skin to be located between the plurality of optical transmitters, such that the plurality of optical transmitters focus light onto the portion of the skin (e.g., the skin on the chest) located between the plurality of optical transmitters.

[0026] In some aspects, the technology described herein relates to an electronic device, wherein an optical sensor assembly includes a plurality of optical detectors including optical detectors, and when the flexible wings are fixed to a user surface, the plurality of optical detectors pinch the user's skin (e.g., the skin on the chest), causing a portion of the skin to be located between the plurality of optical detectors, such that the plurality of optical detectors receive light from the portion of the skin (e.g., the skin on the chest) located between the plurality of optical detectors.

[0027] In some aspects, the technology described herein relates to an electronic device, and when the flexible wings are fixed to a user surface, the optical emitter and the optical detector pinch the user's skin (e.g., the skin on the chest), causing a portion of the skin (e.g., the skin on the chest) to be located between the optical emitter and the optical detector to direct light from the optical emitter through the user's skin (e.g., the skin on the chest) to the optical detector.

[0028] In some aspects, the technology described herein relates to an electronic device, wherein the optical sensor assembly further includes a fiber optical cable or a light guide configured to direct light from the optical emitter to the user's skin (e.g., the chest).

[0029] In some aspects, the technology described herein relates to an electronic device, which further includes a spring configured to apply pressure to increase the contact between the optical emitter and the user's skin (e.g., the chest) and increase the contact between the optical detector and the user's skin.

[0030] In some aspects, the technology described herein relates to an electronic device configured to monitor a user's physiological signals, the electronic device including: a housing at least partially enclosing a circuit board configured to process physiological signals to infer the user's physiological characteristics; flexible wings extending from the housing and configured to conform to a user surface corresponding to the user's chest; an optical sensor assembly located on the flexible wings and configured to acquire a photoplethysmogram signal; and an adhesive layer coupled to the surface of the flexible wings and configured to adhere the electronic device to the user surface, wherein the adhesive layer includes an optically transparent adhesive layer.

[0031] In some aspects, the techniques described herein relate to an electronic device that further includes a brightening film configured to reflect or refract light generated by an optical sensor assembly to a user's skin (e.g., chest).

[0032] In some aspects, the techniques described herein relate to an electronic device, wherein the brightening film is located between an adhesive layer and the optical sensor assembly.

[0033] In some aspects, the techniques described herein relate to an electronic device, wherein the brightening film is integrated with the adhesive layer.

[0034] In some aspects, the techniques described herein relate to an electronic device, wherein the brightening film is substantially flush with the optical elements of the optical sensor assembly.

[0035] In some aspects, the techniques described herein relate to an electronic device, wherein the brightening film is elevated toward the circuit board to provide space for a user's skin (e.g., skin on the chest) to tent.

[0036] In some aspects, the techniques described herein relate to an electronic device, wherein the optical sensor assembly includes a photodiode and a light-emitting diode.

[0037] In some aspects, the techniques described herein relate to an electronic device, wherein an optically transparent adhesive layer couples the photodiode and the light-emitting diode to a user's skin (e.g., chest).

[0038] In some aspects, the techniques described herein relate to an electronic device, wherein the optically transparent adhesive layer surrounds the photodiode and the light-emitting diode without covering them.

[0039] In some aspects, the techniques described herein relate to an electronic device that further includes a wicking material configured to absorb or evaporate sweat or body secretions.

[0040] In some aspects, the techniques described herein relate to an electronic device, wherein the wicking material includes a polyester-based material.

[0041] In some aspects, the techniques described herein relate to an electronic device, wherein the wicking material is interwoven with the adhesive layer.

[0042] In some aspects, the techniques described herein relate to an electronic device, wherein the wicking material is located around the optical elements of the optical sensor assembly.

[0043] In some aspects, the technology described herein relates to an electronic device that further includes channels located around the optical elements of an optical sensor assembly and configured to allow the evaporation or escape of sweat or bodily secretions.

[0044] In some aspects, the technology described herein relates to an electronic device, wherein the channels are within an adhesive layer.

[0045] In some aspects, the technology described herein relates to an electronic device, wherein the circuit board includes a flexible printed circuit board.

[0046] In some aspects, the technology described herein relates to an electronic device, wherein the flexible printed circuit board includes a backing layer having channels that allow the evaporation or escape of sweat or bodily secretions.

[0047] In some aspects, the technology described herein relates to an electronic device, wherein an adhesive layer and the optical elements of the optical sensor assembly are secured to the backing layer.

[0048] In some aspects, the technology described herein relates to an electronic device that further includes a physical barrier between the adhesive layer and the optical elements to prevent adhesive leakage from contacting the optical elements.

[0049] In some aspects, the technology described herein relates to an electronic device, wherein the physical barrier is tilted towards the adhesive layer.

[0050] In some aspects, the technology described herein relates to an electronic device, wherein the adhesive layer includes multiple adhesives.

[0051] In some aspects, the technology described herein relates to an electronic device, wherein the multiple adhesives include a first adhesive and a second adhesive, wherein the first adhesive is closer to the optical elements of the optical sensor assembly than the second adhesive, and wherein the viscosity of the first adhesive is different from the viscosity of the second adhesive.

[0052] In some aspects, the technology described herein relates to an electronic device, wherein the first adhesive is thinner than the second adhesive.

[0053] In some aspects, the technology described herein relates to an electronic device that further includes an adhesive layer at least partially surrounding the optical sensor assembly.

[0054] In some aspects, the technology described herein relates to an electronic device, wherein the adhesive layer at least partially surrounding the optical sensor assembly is not optically transparent.

[0055] In some aspects, the technology described herein relates to an electronic device that further includes a hydrophobic or hydrophilic material at least partially surrounding the optical sensor assembly to direct sweat or bodily secretions away from the optical sensor assembly.

[0056] In some aspects, the techniques described herein relate to an electronic device that further includes perforations located around the optical elements of an optical sensor assembly and configured to allow the evaporation or escape of sweat or body secretions.

[0057] The examples described herein relate to a physiological monitoring device that can be continuously and comfortably worn by a human or animal individual for at least one week or longer, typically for two to three weeks or longer. In some embodiments, the device is specifically designed to sense and record heart rhythm (e.g., electrocardiogram, ECG) data, although in various alternative examples, one or more additional physiological parameters can be sensed and recorded. Such physiological monitoring devices can include a number of features to facilitate and / or enhance the patient experience and enable more accurate and timely diagnosis of arrhythmias.

[0058] Some examples include an electronic device for monitoring a user's physiological signals, the electronic device comprising: a housing enclosing a circuit board; a wing extending from the housing and configured to conform to the user's surface, the flexible wing having a bottom surface and a top surface; an electrode connected to the wing, the electrode being in electrical communication with the circuit board and configured to be positioned in conformal contact with the user's surface to detect physiological signals; an optical sensor; and an adhesive layer connected to the bottom surface of the wing for adhering the electronic device to the user, the adhesive layer having a lower surface, an upper surface interfacing with the bottom surface of the wing, and a thickness between the lower surface and the upper surface. The optical sensor includes a Light Emitting Diode (LED) and at least one photodiode. The wing has a thickness between the bottom surface and the top surface. The optical sensor includes at least one emitter and at least one detector. The optical sensor is connected to the wing. The optical sensor is connected to another wing. The optical sensor includes another LED configured to emit light of a different wavelength than the LED. The LED or the other LED is configured to emit green light. The LED or the other LED is configured to emit infrared light. The LED or the other LED is configured to emit red light. The optical sensor includes at least two photodiodes. The first photodiode illuminates the user's body with infrared light, and the second photodiode illuminates the user's body with red light. The distance between the LED and the at least one photodiode depends on the wavelength of the light emitted by the LED. The distance between the LED and the at least one photodiode depends on the desired penetration depth of the light into the user's skin or body. The circuit board is configured to process electrocardiogram (ECG) data from the electrode and photoplethysmogram (PPG) data from the optical sensor to calculate or infer the user's physiological characteristics. The circuit board is configured to calculate a Pulse Arrival Time (PAT) metric based on the ECG data and the PPG data. The PAT metric is calculated for each heartbeat. The PAT metric is inversely proportional to the user's blood pressure. The user's blood pressure is calculated based on the relationship between peaks and / or troughs in the PPG data and the ECG data. The electronic device is configured to compare the calculated blood pressure with a baseline blood pressure. The baseline blood pressure is received by the electronic device from a third-party blood pressure measurement device. The circuit board is configured to detect peaks and / or troughs in the ECG data and the PPG data. The circuit board is configured to determine the difference between the peaks and / or troughs in the ECG data and the PPG data to calculate the PAT metric. The circuit board is configured to calculate a regression trend for the ECG data and the PPG data. The regression trend is a linear regression trend.The regression trend correlates ECG and / or PPG and / or impedance data with hemodynamic or other characteristics of the user's blood flow or stroke volume. The electronic device according to the preceding claim or other claims herein, wherein the regression trend also tracks the change of the relevant behavior with respect to the ECG or PPG or impedance data value, blood pressure value, and / or time. The electronic device according to any of the preceding claims or other claims herein, wherein the electronic device applies the regression trend to subsequently estimate blood pressure directly based on the ECG and / or PPG and / or impedance sensor data. The circuit board is configured to calculate the wavelength difference between the light emitted from the LED and the light received by the photodiode. The circuit board is configured to determine the user's heart quality based on the calculated difference. The electrodes and optical sensors are disposed on at least one of the following: the user's chest, the user's limbs, the user's torso, the user's arm, the user's upper arm, the user's torso, the user's chest, the user's shoulder, the user's upper arm, the user's wrist, the user's finger, the user's earlobe, the user's forehead, the user's leg, the user's foot, the user's toe, or the user's blood vessel. The electrodes and optical sensors collect data from the user's blood vessel. The electrodes and optical sensors collect data from the same blood vessel. The electrodes and optical sensors collect data from different blood vessels. The electronic device further includes an impedance sensor configured to reduce noise in the collected signal based on the detected motion. The electronic device further includes an impedance sensor configured to measure hemodynamic information. The electronic device further includes an impedance sensor configured to measure impedance cardiography. When estimating blood pressure, the measured impedance cardiography can be applied to improve the accuracy of the PAT index. The electronic device further includes an impedance sensor configured to measure the impedance between the first electrode and the second electrode. The electronic device further includes an impedance sensor configured to measure the impedance between the third electrode and the fourth electrode. The first electrode and the second electrode are closer to the center of the chest compared to the third electrode and the fourth electrode. The electrodes are on the chest and aligned with the spine. The electrodes include a first electrode, a second electrode, a third electrode, and a fourth electrode. The impedance sensor senses between two electrodes or four electrodes. The device applies a current to the first electrode and the second electrode and records the resulting voltage through the third electrode and the fourth electrode. The first electrode and the second electrode are external electrodes, and the third electrode and the fourth electrode are internal electrodes. The current is a low-magnitude current. The device includes a fifth electrode and a sixth electrode, wherein the third electrode, the fourth electrode, the fifth electrode, and the sixth electrode measure the impedance of the user's chest. The first electrode, the second electrode, the third electrode, and the fourth electrode are aligned with the spine. The fifth electrode and the sixth electrode are not aligned with the spine. The first electrode, the second electrode, the third electrode, and the fourth electrode are configured to measure impedance.The fifth and sixth electrodes are configured to measure an ECG signal. The device or an external computing system is configured to determine an atrial fibrillation burden based on detection signals from the electrodes and / or optical sensors. The atrial fibrillation burden includes the amount of time the user spends in atrial fibrillation over a period of time. The atrial fibrillation burden includes the amount of time the user spends in atrial fibrillation during sleep periods and waking periods. The device or an external computing system is also configured to provide a report that includes an indication of the occurrence of an arrhythmia. The report includes a graph of the atrial fibrillation burden over time. The report includes signs of the presence of atrial fibrillation. The report includes at least a monitoring period of 3 days, 14 days, or 21 days. The electronic device is configured to transmit detection signals of the electrodes and optical sensors or derived signals thereof to an external computing device configured to determine the physiological signals of the user. The external computing system is a server or a gateway. The external computing system is a smartphone. The external computing system communicates with the transmitter through a smartphone intermediary. The electronic device further includes an accelerometer configured to measure the movement of the user. If data from the accelerometer indicates high movement of the user, the electronic device is configured to discard the recorded physiological data. The electronic device is configured to remove noise from the recorded physiological data based on the frequency of the motion data. The device or an external computing system is also configured to determine an atrial fibrillation burden that includes the amount of time the user spends in atrial fibrillation during movement. The movement of the user includes a first mobility and a second mobility. The electrodes and optical sensors are included within a chest strap. The electrodes and optical sensors are included within a chest patch. The electrodes and optical sensors are included within a watch and configured to be worn on the wrist. The electrodes and optical sensors are included within a wearable fitness band. The electronic device is configured to detect or infer an arrhythmia based on signals from the electrodes and optical sensors. The arrhythmia includes the onset of an arrhythmia. The arrhythmia includes past-occurring arrhythmias. The arrhythmia includes at least one of the following: ventricular tachycardia, supraventricular tachycardia, ectopic beats, ventricular fibrillation, or prolonged pauses. The housing is configured to be removed from the electronic device and modified when separated from the electronic device. The electronic device is also configured to track the amount of light reflected back to the detector of the PPG sensor. The amount of light reflected back to the detector of the PPG sensor is regulated by pulsating blood flowing through the user's blood vessels. The amount of reflected light corresponds to hemodynamic information. The electronic device is configured to measure the ECG p wave, the ECG R peak, measure the PPG valley and / or trough, measure the inflection point along the systolic pressure rise, and / or determine the weighted center of gravity of each pulse.The electronic device is configured to measure an ECG p-wave and infer arrhythmia based on the measured ECG p-wave. The electronic device is configured to measure an ECG p-wave and determine PAT based on the measured ECG p-wave. The electronic device is configured to measure the delay between a signal from an electrode and a signal from an optical sensor. The user's blood pressure is derived based on the measured delay between the signal from the electrode and the signal from the optical sensor. The electronic device is configured to measure a voltage potential through an electrode of a cardiac (including sinoatrial node and / or atrioventricular node) circuit. The electronic device further includes a capacitor configured to decouple noise caused by other circuits. The electronic device is configured to measure total conductivity by driving a current between electrodes and measuring the voltage between other electrodes. The electrodes are driven by the same input signal. The electrodes include a first electrode, a second electrode, a third electrode, and a fourth electrode. Impedance can be sensed between two of the four electrodes. The sensed impedance can be acquired on a vertical vector substantially parallel to the aorta. The sensed impedance can be acquired at an angle to the heart. The first electrode and the second electrode are respectively disposed above and below the heart. The third electrode and the fourth electrode are respectively disposed on the left and right sides of the heart. The first electrode and the second electrode are respectively disposed on the left and right sides of the heart.

[0059] Some examples include an electronic device for monitoring a user's physiological signals, the electronic device including: a housing enclosing a circuit board; an electrode connected to the housing, the electrode being in electrical communication with the circuit board and configured to be positioned in conformal contact with the user's surface to detect physiological signals; a light-emitting diode (LED) and a detector connected to the circuit board, the LED being configured to emit light and the detector being configured to detect light; and an adhesive layer for adhering the electronic device to the user.

[0060] Some examples include an electronic device for monitoring a user's physiological signals, the electronic device comprising: a housing enclosing a circuit board; electrodes connected to the housing, the electrodes being in electrical communication with the circuit board and the electrodes being configured to be positioned in conformal contact with the user's surface to detect physiological signals; a transmitter and a detector connected to the circuit board, the transmitter being configured to emit light and the detector being configured to detect light; and an adhesive layer for adhering the electronic device to the user. The electronic device includes a conformal coating on the LED and the detector. A conformal coating is further applied between the LED and the detector. The conformal coating between the LED and the detector is flush with the coating on the LED or the detector. The conformal coating between the LED and the detector is depressed from the coating on the LED or the detector. The thickness of the conformal coating is between 10 μm and 1000 μm. The thickness of the conformal coating is between 50 μm and 500 μm. The thickness of the conformal coating on the LED is substantially similar to the thickness of the conformal coating on the detector. The electronic device further includes a barrier between the LED and the detector, wherein the barrier is configured to reduce or eliminate crosstalk between the LED and the detector, and wherein the conformal coating is also applied on the barrier. The barrier is an opaque barrier. The opaque barrier prevents or mitigates the effect of ambient light external to the electronic device on the LED or the photodiode. The opaque barrier is at least one of the following: placed adjacent to the LED or the photodiode and domed; placed above the LED or the photodiode and annular and surrounding the LED or the photodiode, or washer-shaped and surrounding the LED or the photodiode. The electronic device further includes a reflective layer disposed adjacent to the barrier. The reflective barrier is configured to contact the patient's skin and prevent another barrier from contacting the patient's skin. The reflective barrier is configured to reflect light emitted from the user's body back to the user's body. The reflective barrier is configured to reflect light emitted from the user's body from the effective area of the detector back to the effective area of the detector. The LED is configured to indent the user's skin. The detector is configured to indent the user's skin. The electronic device further includes an additional adhesive layer configured to hold the LED and the detector firmly on the user's skin. The adhesive layer forms an outer adhesive layer and the additional adhesive layer forms an inner adhesive layer. The outer adhesive layer is thicker than the inner adhesive layer. The outer adhesive layer has greater adhesive properties than the inner adhesive layer. The outer adhesive layer includes a load bearing adhesive and the inner adhesive layer includes an optically transparent adhesive. The inner adhesive layer includes a harder material than the outer adhesive layer. The distance between the middle of the LED and the edge of the detector closer to the LED is at least between the following values: 2 μm to 3 μm, 6 μm to 8 μm, or 10 μm to 30 μm. The housing includes a first mating part and the adhesive layer includes a second mating part, wherein the housing is configured to be separated from or connected to the adhesive layer through the first mating part and the second mating part. The detector detects light emitted from the LED that passes through the user's skin.The detector detects light reflected from the user's body that is emitted by a detection LED. The electronic device further includes a first glass lens configured to direct light from the LED to the user's skin. The electronic device further includes a second glass lens configured to direct light from the user's skin to the detector. The electronic device further includes a barrier located between the first glass lens and the second glass lens, the barrier being configured to block at least a portion of the light from being transmitted directly from the LED to the detector. The first glass lens or the second glass lens includes at least one of the following: dome-shaped, spherical, meniscus-shaped, or a dome-shaped that is curved 180 degrees. The first glass lens or the second glass lens includes a dome shape that is configured to contact the skin surface and another portion that contacts the barrier. The first glass lens or the second glass lens includes a dome shape, wherein the entire curved portion is configured to contact the user's skin. The detector is configured to detect at least a portion of the light emitted from the LED that is transmitted directly through the user's skin from the first glass lens to the second glass lens. The electronic device according to any one of the preceding claims or other claims herein, wherein the detector is configured to detect at least a portion of the light emitted from the LED that is transmitted out of the first glass lens, modulated by the user's pulsating blood, and emitted from the user's body to the second glass lens. The electronic device according to any one of the preceding claims or other claims herein, wherein the electronic device is further configured to combine the transmitted light and the reflected light and combine the signals for inference. The electronic device according to any one of the preceding claims or other claims herein, wherein the first glass lens or the second glass lens is configured to press into the user's skin. The first glass lens and the second glass lens are configured to press into the user's skin. The amount of pressing-in is based on the amount of emitted light transmitted from the first glass lens to the second glass lens. The amount of pressing-in depends on whether the surface blood vessels are blocked due to the pressing-in, resulting in the inability to capture the signals of the surface blood vessels. The electronic device further includes a glass lens configured to direct light from the user's skin to the detector. The electronic device is configured to emit light to the user's chest. The electronic device is configured to detect light from the user's chest. The LED and the detector are both placed on the user's chest, rather than the back. The LED or the detector is configured to press into the user's skin. The electronic device further includes an optically transparent film or adhesive having wavelength guiding characteristics, which is configured to redirect the light to the patient's skin at one or more angles closer to the detector. The detector is configured to press into the user's skin, thereby forming a tented area of the skin, wherein the detector is configured to detect the light passing through the tented portion of the skin through the LED. The detector is placed on a first track, and the LED is placed on a second track, wherein the detector and the LED are respectively elevated from the board through the first track and the second track.The detector is configured to press on one side of the user's skin, and a second detector is configured to press on the other side of the user's skin to form a tented area of the skin, wherein the detector and the second detector are configured to detect light from an LED passing through the tented area of the skin. The LED is configured to press on the user's skin to form a tented area of the skin, wherein the detector is configured to detect light emitted by the LED to the tented area of the skin. The LED is configured to press on one side of the user's skin, and a second LED is configured to press on the other side of the user's skin to form a tented area of the skin, wherein the detector is configured to detect light emitted by the LED and the second LED to the tented area of the skin. The LED is configured to emit light directionally to the tented area of the skin. The wearable device further includes light piping configured to guide light from the LED and emit the light to the tented area of the skin. The light piping is configured to channel light in the direction of the tented area of the skin, rather than in the opposite direction of the tented skin. The light piping is configured to achieve refractive index matching among at least two of the following: the LED, air, the user's skin, or a lens. The LED is in a circular ring shape. The LED is in an incomplete circular ring shape. The electronic device includes one or more microfluidic channels configured to allow sweat or mucus to escape. The one or more microfluidic channels are adjacent to the LED or the detector. The electronic device according to any one of the preceding claims or other claims herein, wherein the electronic device further includes one or more microfluidic channels configured to evaporate sweat or mucus. The electronic device further includes a contact portion that applies pressure on a portion of the LED or the detector toward the patient's skin. The electronic device further includes a wicking material on the contact portion configured to press on the LED or the detector. The electronic device further includes a physical barrier that blocks the adhesive layer from overflowing onto the LED or the detector over time during use of the electronic device. At least a portion of the physical barrier is inclined toward the adhesive layer. The LED is configured to emit light of a first wavelength toward the tented area, and the electronic device further includes a second LED configured to emit light of a second wavelength toward the tented area. The detector is configured to detect light from the LED and the second LED, wherein the electronic device is configured to filter light from the LED and light from the second LED. The electronic device further includes filtering light received at a photodiode. The electronic device is configured to filter light of a specific wavelength or wavelength range received at the photodiode. The electronic device is configured to filter light by a physical filter placed near or adjacent to the photodiode. The electronic device is configured to filter light through signal processing. The detector is configured to detect light from the LED and the second LED simultaneously. When the LED emits light of a first wavelength, the second LED is turned off.The second LED is configured to indent the user's skin on a second side of the skin tented area, wherein the detector is configured to detect light emitted by the LED and the second LED to the skin tented area. The second LED also forms a second tented area of the skin, wherein the second detector is configured to detect light emitted by the second LED to the second tented area. The third LED is also configured to indent the user's skin to help form the second tented area of the skin, wherein the second detector is configured to detect light emitted by the second LED and the third LED to the second tented area. A plurality of LEDs including the LED and a plurality of detectors including the detector are arranged in a circular array. The tented area of the skin is within the inner area of the circular array. A plurality of LEDs including the LED are arranged in a linear array. A plurality of detectors including the detector comprising the LED are arranged in a linear array. The electronic device further includes a lens for guiding light from the LED to the skin tented area. The lens has a first surface that is not adjacent to the tented area of the skin and a second surface that is adjacent to the tented area of the skin, wherein the first surface is more transparent than the second surface such that more light passes through the first surface than through the second surface. The electronic device further includes a second adhesive layer, wherein the adhesive layer and the second adhesive layer have different adhesive properties. The adhesive layer includes one or more openings or slits. The electronic device further includes one or more wicking materials configured to evaporate sweat or goop. One or more wicking materials are intertwined with the adhesive. One or more wicking materials are placed near the adhesive. The electronic device further includes a flexible layer placed on top of the LED and the detector, wherein the flexible layer is configured to apply pressure towards the patient's skin to the LED and the detector when the user wears the electronic device. The electronic device further includes an opaque barrier disposed between the LED and the detector. The opaque barrier is closer to the LED than the detector. The electronic device further includes a first set of optical fibers connected to the LED, wherein the first set of optical fibers emits light from the LED to the user's skin. The electronic device further includes a second set of optical fibers connected to the photodiode, wherein the second set of optical fibers detects a light signal from the user's skin and transmits the signal to the photodiode. The electronic device further includes a brightness enhancement film disposed between the LED and the detector. The electronic device further includes an optically transparent adhesive layer configured to adhere the LED to the user's skin. The electronic device further includes an optically transparent adhesive layer configured to adhere the detector to the user's skin. Electrodes are placed on a body part different from the LED or the photodiode. The electrodes are fixed to the body skin by an adhesive portion different from the LED or the photodiode. The electrodes are fixed to the body skin by an adhesive different from the LED or the photodiode. The electronic device further includes a flexible board, wherein the photodiode and the LED are placed on the flexible board. The flexible board warps to form a protrusion or a depression such that when the electronic device is applied to the patient's skin, a dent or a tented area is formed on the skin. The flexible board is flexible to conform to the curvature of the skin.The electronic device further includes a rigid board, on which a photodiode and an LED are disposed. The electronic device further includes converting the light received at the photodiode into an electrical signal and transmitting the electrical signal to the housing. The electronic device further includes transmitting the light received at the photodiode to the housing, and the circuit within the housing is configured to convert the light into an electrical signal. The electronic device further includes a film configured to allow light to pass in one direction but not in the other direction. The film is configured to allow light to pass from the LED but not to shine on the LED. The film is configured to allow light to pass from the photodiode but not to shine on the photodiode. The electronic device further includes a hydrophilic material below or around the LED or the photodiode, wherein the hydrophilic material is configured to suck out fluid from the LED or the photodiode. The electronic device further includes a hydrophobic material between the LED and the photodiode, wherein the hydrophobic material is configured to keep the fluid away from both the LED and the photodiode. The electronic device further includes a hydrophobic material on the LED or the photodiode. The electrode is located on the first wing, and the LED and the photodiode are located on the second wing. The electrode is located on the same wing as the LED and the photodiode. The electronic device is configured such that while being pressed by the user, the LED emits light and the photodiode collects a PPG signal. The electronic device is configured such that while the user presses, the electrode collects an ECG signal. The electronic device is configured to determine blood pressure after the user presses the electronic device for a period of time. At least a portion of the trace for the electrode is parallel to at least a portion of the trace for the optical sensor. The electronic device further includes a second electrode and a second adhesive, wherein the first adhesive is configured to hold the electrode on the user's skin, and the second adhesive is configured to hold the second electrode and one or more optical sensors on the user's skin. The first adhesive and the second adhesive are physically separated. The optical assembly is configured to be detachable from the electronic device. The electronic device is configured to input a signal characteristic to the LED and apply a matched filter to the optical signal received by the photodiode.

[0061] Although certain embodiments and examples are disclosed herein, the subject matter of the present invention extends beyond the examples in the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as their modifications and equivalents. BRIEF DESCRIPTION OF THE DRAWINGS

[0062] Figures 1A to 1B Multiple views showing an example of a physiological monitoring device. Figure 1A A perspective view showing the physiological monitoring device. Figure 1B An exploded view showing the physiological monitoring device.

[0063] Figures 2A to 2D Multiple views showing an example of a physiological monitoring device. Figure 2A Showing a top perspective view, Figure 2B Showing a bottom view, Figure 2C Showing a top perspective view including a liner,Figure 2D Shows a bottom view including a gasket.

[0064] Figures 3A to 3H Shows various views of an example of a physiological monitoring device. Figure 3A Is a perspective view, Figure 3B Is a top view, Figure 3C Is a bottom view, Figure 3D1 Is a side view. Figure 3D2 Shows a side view of a ridge configured to seal the top and bottom of the housing. Figure 3E And Figure 3F Show the bottom view and top view of the physiological monitoring device, where the layers are shown transparently to provide visualization through the device. Figure 3G And Figure 3H Show an exploded view of the various components of the physiological monitoring device.

[0065] Figure 4 Is a schematic diagram of a sensor platform provided according to an example.

[0066] Figure 5A 、 Figure 5B And Figure 5C Provide schematic diagrams according to at least one example.

[0067] Figure 6 Is a schematic diagram of a device according to an example.

[0068] Figure 7 Is a schematic diagram of a device according to an example.

[0069] Figure 8 Is a schematic diagram of an optical sensor according to an example.

[0070] Figure 9 Is a schematic diagram of a user blood pressure reference according to an example.

[0071] Figure 10A And Figure 10B Provide schematic diagrams of user ECG data and PPG data according to an example.

[0072] Figure 11 Is a schematic diagram of the change of a user's pulse arrival time (PAT) with measurement time according to an example.

[0073] Figure 12A Is an example of an electrode for measuring thoracic conductivity according to an example.

[0074] Figure 12B Is an example of an electrode for measuring thoracic conductivity and ECG sensor conductivity according to an example.

[0075] Figure 13AIs an impedance cardiogram according to an example.

[0076] Figure 13B Is a graph determined according to an example of the pulse arrival time.

[0077] Figure 14A Shows a side view of an example of an optically transparent adhesive under a photodiode and an LED according to some examples.

[0078] Figure 14B Shows a top view of an optically transparent adhesive under a photodiode and an LED according to some examples.

[0079] Figure 15A Shows an example of pressing into a patient's skin according to some examples.

[0080] Figure 15B Shows an example of pressing into a patient's skin using two extensions of a wearable device according to some examples.

[0081] Figure 15C Shows an example of applying an optical cable to emit light into a skin depression according to some examples.

[0082] Figure 16 Shows a top view of an example of releasing sweat or other mucus from an electronic component according to some examples.

[0083] Figure 17 Shows an example having a contact portion that applies pressure to an LED and / or a photodiode for better connection to the skin according to some examples.

[0084] Figure 18A Shows an example of a physical barrier that prevents the adhesive from overflowing onto an electronic device according to some examples.

[0085] Figure 18B Shows an example of a single LED in a circular or annular shape according to some examples.

[0086] Figure 19 Shows an example of an LED emitting light of different wavelengths according to some examples.

[0087] Figure 20 Shows an example of repeating LEDs and photodiodes according to some examples.

[0088] Figure 21 Shows an example of different adhesives for a wearable device according to some examples.

[0089] Figure 22A Shows an example of a single LED and a single photodiode according to some examples.

[0090] Figure 22BAn example of an LED array and a photodiode array according to some examples is shown.

[0091] Figure 22C An example of LEDs and photodiodes distributed in a circular array according to some examples is shown.

[0092] Figure 23A An example of a protrusion having an illumination channel according to some examples is shown.

[0093] Figure 23B An example of using a ring or a light guide according to some examples is shown.

[0094] Figure 24 An example of a leaf spring pressing down on certain components of a wearable device according to some examples is shown.

[0095] Figure 25 An example of a bowl-shaped flexible circuit pressed into the skin according to some examples is shown.

[0096] Figure 26A An example of an opaque barrier between an LED and a photodiode according to some examples is shown.

[0097] Figure 26B An example of a pseudo-transmission directly from an LED to a photodiode through a raised area of the skin according to some examples is shown.

[0098] Figure 27A A cross-sectional view of an example of using a bundle of optical fibers for an LED and a photodiode according to some examples is shown.

[0099] Figure 27B A side view of an example of using a bundle of optical fibers according to some examples is shown.

[0100] Figure 28A An example of skin connection through two doming compounds according to some examples is shown.

[0101] Figure 28B Another example of skin connection through two doming compounds according to some examples is shown.

[0102] Figure 28C An example of circuit 2840 and circuit 2860 according to some examples is shown.

[0103] Figure 28D An example of skin connection using an inwardly curved crescent-shaped glass lens according to some examples is shown.

[0104] Figure 29A An example of the use of a high refractive index material according to some examples is shown.

[0105] Figure 29B A dome-shaped composite is shown protruding beneath an opaque barrier according to some examples.

[0106] Figure 29C Shown are examples of ball lenses according to some examples.

[0107] Figure 30A Examples of using waveguides on a surface are shown according to some examples.

[0108] Figure 30B An example of a waveguide flex circuit 3006 is shown according to some examples.

[0109] Figure 30C Examples of adhesives for dome-shaped glass lenses according to some examples are shown.

[0110] Figure 30D Examples of adhesives for inverted dome-shaped glass lenses according to some examples are shown.

[0111] Figure 31A An example of ray tracing of light emitted by an LED according to some examples is shown.

[0112] Figure 31B An example of ray tracing of detection light is shown according to some examples.

[0113] Figure 31C , Figure 31D , Figure 31E , Figure 31F and Figure 31G An example of applying a circular base on a flexible board under the LED / detector is shown according to some examples.

[0114] Figure 32 A mold for a sapphire hemispherical glass lens is shown according to some examples.

[0115] Figure 33A A clamp that can clamp an O-ring is shown according to some examples. Figure 33B Showing some examples Figure 33A Top view of the . Figure 33C Shown are side and cross-sectional views of an O-ring according to some examples.

[0116] Figure 34A A prototype of a skin connection example according to some examples is shown. Figure 34B and Figure 34C Examples of different amounts of optical barriers applied according to some examples are shown. Figure 34D and Figure 34E A skin connector is shown in use according to some examples. Figure 34FShows another example of a skin connector according to some examples, where multiple fingers can be placed on the LED.

[0117] Figure 35A And Figure 35B Shows an example of skin connection using a conformal coating according to some examples.

[0118] Figure 36A Shows an example of how light is emitted from a transmitter to a patient's skin according to some examples. Figure 36B And Figure 36D Shows an example of a photodiode, a detector, and an epoxy bridge between them according to some examples. Figure 36C And Figure 36E Shows a bridge thicker than the Figure 36A bridge in

[0119] Figure 37A And Figure 37C Shows a first example of a skin connection example, Figure 37B And Figure 37D Shows a second example of a skin connection example.

[0120] Figures 38A to 40B Shows an example of an adhesive portion that mates with an electronic device housing according to some examples.

[0121] Figure 41 Shows a diagram for determining ECG signals and PPG signals for PPT according to some examples.

[0122] Figure 42 Shows a diagram for calculating PPT as an integral using R-peak information according to some examples. Detailed Description

[0123] The following description pertains to multiple different embodiments. However, the described embodiments may be implemented and / or evolutionary changes may be made to the described embodiments in many different ways. For example, the described embodiments may be implemented in any suitable device, apparatus, or system to monitor any one of a variety of physiological parameters. For example, the following discussion focuses primarily on long-term, patch-based heart rhythm monitoring devices. In an alternative embodiment, the physiological monitoring device may be used, for example, for pulse oximetry and the diagnosis of obstructive sleep apnea. The methods of using the physiological monitoring device may also vary. In some cases, the device may be worn for a week or less, while in other cases, the device may be worn for at least seven days and / or more than seven days, such as between fourteen and twenty-one days, or even longer. Many other alternative embodiments and applications of the described technology are possible. Therefore, the following description is for exemplary purposes only. Throughout the specification, reference may be made to the term "conformal". Those skilled in the art will understand that the term "conformal" as used herein refers to the relationship between surfaces or structures, where the first surface or structure adapts to the contour of the second surface or structure.

[0124] Since cardiac arrhythmias or dysrhythmias are often caused by other less serious reasons, a key challenge is to determine when these symptoms are caused by an arrhythmia. Typically, arrhythmias occur rarely and / or occasionally, which makes rapid and reliable diagnosis difficult. As described above, currently, heart rhythm monitoring is mainly achieved by using devices such as Holter monitors, which use electrodes fixed to the chest for a short duration (less than 1 day). Wires connect the electrodes to a recording device that is usually worn on a belt. The electrodes need to be changed daily and the wires are cumbersome. The memory and recording time of these devices are also limited. Wearing the device interferes with the patient's movement and usually hinders certain activities, such as bathing, during monitoring. In addition, Holter monitors are fixed devices with limited availability, which usually results in supply restrictions and corresponding test delays. These limitations severely impede the diagnostic usefulness of the device, the patient compliance in using the device, and the possibility of capturing all important information. Lack of compliance and the disadvantages of the device often lead to the need for additional devices, follow-up monitoring, or other tests to make a correct diagnosis.

[0125] Current methods of linking symptoms to the occurrence of arrhythmias (including the use of cardiac rhythm monitoring devices such as Holter monitors and cardiac event recorders) are generally insufficient to make an accurate diagnosis. In fact, Holter monitors have been shown to be unable to make a diagnosis up to 90% of the time (“Assessment of the Diagnostic Value of 24-Hour Ambulatory Electrocardiographic Monitoring”, by DE Ward et al. Biotelemetry Patient Monitoring, vol. 7, published in 1980).

[0126] In addition, the medical process of actually obtaining a cardiac rhythm monitoring device and initiating monitoring is often very complex. Ordering, tracking, monitoring, retrieving, and analyzing data from such monitoring devices typically involves many steps. In most cases, currently used cardiac monitoring devices are ordered by cardiologists or cardiac electrophysiologists (EPs), rather than by the patient's primary care physician (PCP). This is important because the PCP is usually the first doctor to see the patient and determine that the patient's symptoms may be due to an arrhythmia. After the patient visits the PCP, the PCP will schedule an appointment for the patient to see a cardiologist or EP. This appointment is usually several weeks after the PCP's first visit, which itself can cause a delay in potential diagnosis, as well as an increased likelihood of arrhythmia episodes going undiagnosed. When the patient finally sees a cardiologist or EP, a cardiac rhythm monitoring device is usually ordered. The monitoring period can last from 24 to 48 hours (Holter monitor) or up to a month (cardiac event monitor or mobile telemetry device). Once the monitoring is complete, the patient usually has to return the device to the clinic, which can itself be inconvenient. After data is processed by on-site technicians at a monitoring company or hospital or office, the report will ultimately be sent to the cardiologist or EP for analysis. This complex process results in fewer patients undergoing cardiac rhythm monitoring than would be ideal.

[0127] To address some of the problems in cardiac monitoring, the assignee of the present application has developed various examples of small, long-term, wearable physiological monitoring devices. One example of the device is developed and sold by iRhythm Technologies, Inc. Patch. Various examples of cardiac monitors developed and sold by iRhythm Technologies are described in the following U.S. patents, for example: 8,160,682; 8,244,335; 8,150,502; 8,560,046; 8,538,503; 9,241,649; 10,405,799; 10,517,500; 11,141,091; 10,271,754; 10,555,683; 11,051,738; D852,965; D854,167; 9,173,670; 9,451,975; 9,597,004; 9,955,887; 10,098,559; 10,299,691; 10,667,712; 10,813,565; 11,289,197; 11,350,864; 11,350,865; 11,337,632; 11,246,523; 11,399,760; 11,246,524; 11,382,555; 11,083,371; 11,253,185; 11,253,186; 11,375,941, the entire disclosures of which are incorporated herein by reference. Generally, the physiological patch-based monitors described in the above references can be comfortably worn on a patient's chest and are designed to be worn for at least one week, typically two to three weeks. The monitor continuously detects and records heart rhythm signal data while the device is worn, and then this heart rhythm data can be processed and analyzed.

[0128] This small, long-term, patch-based physiological monitoring device has many advantages over prior art devices. At the same time, further improvements are needed. One of the most significant areas for improvement is to issue more timely notifications of serious arrhythmias to managing clinicians. These initial examples are characterized in that, for reasons of performance, compliance, and cost, the device only records information during an extended wear period and analyzes and reports after the recording is complete. Therefore, a desirable improvement is to increase the ability to perform real-time or timely analysis of the collected heart rhythm information. Although there are currently diagnostic monitors with such timely reporting capabilities, they require periodic charging or replacement of one or more electronic components of the system. These operations reduce patient compliance, which in turn reduces the diagnostic rate. Therefore, a key area for improvement is to develop a physiological monitor that can combine long-term recording with timely reporting without the need to charge or replace the battery.

[0129] Patient compliance and device adhesion performance are two factors that determine the duration of ECG recording and thus the diagnostic rate. By improving the patient's wearing experience, compliance can be increased. The wearing experience is affected by wearing comfort, device appearance, and the degree to which the device hinders normal daily activities. Given that longer ECG recordings provide a higher diagnostic rate and thus value, improving device adhesion and patient compliance is needed.

[0130] Signal quality is important throughout the wearing period, but may be even more important where the patient marks the recording, indicating areas of clinical symptomatic significance. Marking the recording is most easily achieved through a trigger located on the outer surface of the device. However, since the trigger may be part of a skin contact platform with integrated electrodes, the patient may introduce significant motion artifacts when touching the trigger. An ideal device improvement would be a symptomatic trigger that can be activated with minimal addition of motion artifacts.

[0131] In addition, it is desirable for the device to be simple and cost-effective to manufacture, enabling scalability of manufacturing and improved quality due to process repeatability. The simplicity of manufacturing can also make disassembly easy, enabling the effective recycling of printed circuit boards for quality-controlled reuse in another device. The effective reuse of such expensive components is important for reducing the cost of diagnostic monitors.

[0132] In some clinical scenarios, longer-duration and lower-cost solutions may be valuable additions to the portfolio of cardiac dynamic monitoring options. Inspiration for potential solutions to these needs can be found in continuous heart rate sensing capabilities, which are increasingly being incorporated into a variety of consumer health and fitness products, including smartwatches and wearable fitness bands. Although continuous heart rate data can be used to provide information to users about their overall health level, using this data to provide meaningful information related to their health and wellness is more challenging and valuable. For example, the ability to detect potential arrhythmias from continuous heart rate data would enable consumer devices incorporating heart rate sensing capabilities to serve as potential screening tools for early detection of cardiac arrhythmias. Such an approach may have clinical value in providing long-term, cost-effective screening methods for high-risk populations (such as heart failure patients at risk of atrial fibrillation). Alternatively, such a monitoring method can, for example, assist in the long-term titration of therapeutic drug doses in the management of paroxysmal atrial fibrillation to ensure efficacy while reducing side effects. In addition to arrhythmia detection, appropriate analysis of heart rate information can also provide insights for sleep and stress-related applications.

[0133] Long-term dynamic monitoring with physiological devices (such as adhesive patches) has many clinical applications, especially when it can provide timely information about the occurrence and duration of observed arrhythmias during monitoring. In terms of prevalence, especially driven by the aging population, effective detection of atrial fibrillation (AF) remains the most important monitoring need. This need is obvious not only for symptomatic patients, but also considering the increased stroke risk associated with this arrhythmia, and there is a need for more extensive, population-based asymptomatic AF monitoring for individuals at risk due to the presence of one or more of the following factors: advanced age, chronic diseases such as heart disease, and even undergoing surgery. For the latter group of patients, both perioperative and postoperative monitoring have clinical value, not only for surgeries aimed at preventing arrhythmias (e.g., MAZE ablation surgery or hybrid endocardial and epicardial surgeries, both used to treat AF), but also for general surgeries involving anesthesia. For some applications, the goal of dynamic monitoring for atrial fibrillation sometimes focuses on the simple binary question of whether AF occurs within a given time. For example, monitoring patients after ablation surgery usually seeks to confirm the success of the surgery, which is usually defined as the complete absence of AF. Similarly, monitoring patients after a stroke will mainly focus on assessing the presence of atrial fibrillation.

[0134] However, even in these scenarios, if AF occurs, it may also be clinically significant to evaluate other aspects to better characterize its occurrence, either in absolute terms or compared to a previous baseline (e.g., from baseline, preoperative monitoring results), such as the daily burden (percentage of time in AF per day) and episode duration (e.g., represented by a histogram of episode durations or the percentage of episodes exceeding a specified limit (e.g., six minutes)). In fact, measuring the daily AF burden, assessing the AF episode duration, reviewing the occurrence of AF during sleep and wake periods, and evaluating the presence of AF based on the degree of the patient's body movement are important in various clinical scenarios, including evaluating the effectiveness of drug-based treatments for this arrhythmia.

[0135] Providing this information in a timely manner during monitoring allows the treating physician to repeatedly and gradually adjust the treatment plan, such as by adjusting the dose and frequency of novel oral anticoagulant drugs (NOACs) until optimization of management. Another example of this management paradigm is that patients receive notifications of asymptomatic AF - which can be directly by the device via a voice reminder or vibration-based reminder, via an application connected to the device, or via a phone call, email, or text message from the treating clinician - so that the "pill in the pocket" can be applied in a timely manner for AF management.

[0136] The importance of timely management and / or intervention in the event of clinically significant arrhythmias is evident, such as asymptomatic second-degree and complete heart block, prolonged pauses, high-frequency supraventricular tachycardia, prolonged ventricular tachycardia, and ventricular fibrillation. For example, the clinical situation where a prolonged pause or complete heart block results in syncope is a particularly important case, in which the availability of timely and reliable monitoring methods can reduce or even eliminate the need for in-hospital monitoring of high-risk patients. This theme can also be extended to more subtle changes in morphology, such as drug-induced QT prolongation, which has been shown to be of great significance for cardiac safety. Timely awareness of such prolongation may lead to, for example, the early termination of clinical studies evaluating the safety and efficacy of drugs, or the adjustment of dosage or frequency as a means of eliminating the observed prolongation.

[0137] Physiological monitoring device

[0138] Figures 1A to 1B Multiple views showing non-limiting examples of the physiological monitoring device 100 are presented. Additional details of the physiological monitoring device 100 are disclosed in U.S. Patent No. 11337632, the entire content of which is incorporated herein by reference for all purposes herein. The physiological monitoring device 100 may include one or more components described in other parts of this document. The physiological monitoring device 100 may include a housing 115, which includes an upper housing 140 and a lower housing 145 that are configured to fit together and sandwich the flexible body 110 between the upper housing 140 and the lower housing 145. The flexible body 110 may include a trace layer that forms a wing of the physiological monitoring device 100 and one or more base layers. The wing may include an adhesive layer and electrodes as described in other parts of this document. The rigid body and / or the housing 115 may enclose the PCBA 120, the flexible upper housing 140, the battery 160, the battery terminal connector 150, a portion of the trace layer, the spring contact spacer 132, and the spring 165.

[0139] Figure 1A A perspective view showing an example of the physiological monitoring device 100 is presented. Figure 1B An exploded view showing the physiological monitoring device 100 is presented.

[0140] As described elsewhere in this document, the upper housing 140 and the lower housing 145 can sandwich the flexible body 110 therebetween. In some embodiments, the flexible body 110 can include one or more apertures 138 that extend through one or more layers of the base layer to provide breathability and moisture management and / or facilitate drug delivery to the surface of the skin, as described elsewhere in this document. An upper gasket layer and / or a lower gasket layer (not shown) can be disposed on opposite sides of the flexible body 110. The gasket layer can be an adhesive for adhering to the flexible body 110. A compressible seal can be formed above and / or below the flexible body 110. In some embodiments, a compression seal can be formed with the upper housing 140. The upper housing 140 can be a flexible frame. The battery 160 can be located below the flexible body 110 that includes a trace layer. The PCBA 120 can be located above the flexible body 110 that includes a trace layer. The battery terminal connector 150 can be adhered or otherwise connected to the battery 160 such that a first battery trace and a second battery trace (not shown) are exposed on the outer surface of the battery terminal connector 150 on the top side of the battery 160. The first battery trace and the second battery trace can be exposed to the internal volume of the upper housing 140 through a large central opening in the housing region of the trace layer.

[0141] The electrical contact between the PCBA 120 and the first and second battery traces and / or the electrical connection between the PCBA 120 and the electrocardiogram interface portions of the electrical traces 111, 112 can be established through spring contacts. The spring contacts can be connected to the bottom surface of the PCBA 120. The housing 115 can include a spring contact pad 132 located below the PCBA 120. In some embodiments, the spring contact pad 132 can be rigidly fixed (e.g., adhered) to the bottom of the PCBA 120. In an embodiment, the spring contact pad can be attached or integrated into the flexible body 110. In some embodiments, the spring contact pad can be integrated into the battery terminal connector. The spring contact pad 132 can include a flat body and a plurality of downwardly extending legs 133. The legs 133 can be configured to abut against the top surface and / or side surface of the battery 160 such that the spring contact pad 132 maintains a minimum spacing distance between the battery 160 and the PCBA 120 and provides sufficient space for the spring contacts. The spring contact pad 132 can include one or more holes through which the spring contacts can extend downward from the bottom surface of the PCBA 120. The lower housing 145 can include a spring 165, as described elsewhere herein, located below the battery 160. The spring 165 can bias the battery 160 upward and can bias the first and second battery traces into physical and electrical contact with the corresponding spring contacts. The electrocardiogram interface portions of the traces 111, 112 can be located on the top side of the battery 160 such that biasing the battery 160 upward also causes the electrocardiogram interface portions of the traces 111, 122 to make physical and electrical contact with the corresponding spring contacts. The substantially consistent spacing between the traces and the PCBA 120 provided by the spring 165 and the spring contact pad 132 can reduce, minimize, or eliminate noise in the electrical signals caused by variations in the degree of electrical contact between the spring contacts and the traces. The assembly can include at least one spring contact for the first battery trace, the second battery trace, the first electrical trace 111, and the second electrical trace 112, respectively. The assembly can include multiple spring contacts for some or all of the traces. The spring contacts can be configured under compression caused by the arrangement of various components including the spring 165 to establish an electrical path between each trace and the PCBA 120. The compressive contact between the spring contacts and the traces can be maintained even in the case of a nominal change in the spacing distance between the traces and the PCBA 120 (e.g., caused by movement), because if the spacing distance increases and the bias decreases accordingly, the spring contacts may extend further downward. In some embodiments, the first and second battery traces can be configured to be located on a side of the housing 115 opposite the first and second electrical traces 111, 112.In some embodiments, the spring contacts may be configured to carry electrical signals or electrocardiogram signals from the battery by contacting electrical traces applied to the upper housing 140 or the lower housing 145. These electrical traces may be applied to the housing by using direct structuring with a laser, plating onto a plastic substrate in a secondary molding process, or by aerosol jet printing, inkjet printing, or screen printing of a conductive material. In some embodiments, an RF antenna for wireless communication (e.g., Bluetooth) may be configured by using such electrical traces in the upper housing 140 or the lower housing 145.

[0142] Figures 2A to 2D Shows an example of Figures 1A to 1B Multiple views of a physiological monitoring device 200 that is similar to the physiological monitoring device shown in. Here, the physiological monitoring device includes an intermediate housing 202 that includes an upper housing 204 and a lower housing 206 sandwiched on a flexible substrate. Those skilled in the art will understand that the housing may be made of any suitable material disclosed herein, such as a rigid polymer or a soft flexible polymer. In some embodiments, the housing may include an indicator 208, which may be of any suitable shape, such as oval, circular, square, or rectangular. The indicator may include an LED light source (not shown) or any suitable light source, which may be covered by a transparent or translucent viewing layer located on the inner surface of the upper housing. The viewing layer may be made of thermoplastic polyurethane or any suitable material. The indicator may be used to indicate the status of the physiological monitoring device, such as the battery life of the physiological monitoring device. In some embodiments, the indicator may indicate whether the physiological monitoring device is collecting data, transmitting data, paused, encountering an error, or analyzing data. The indicator may display any suitable color, such as red, amber, or green.

[0143] Multiple wings 212 extend outward from the housing. Those skilled in the art will understand that although two wings are shown here, some embodiments of the physiological monitoring device 200 may include more than two wings. As described in other parts of the specification, the shape of the wings can be designed to improve adhesion to the skin and keep the physiological monitoring device on the skin. In an embodiment, the wings may be asymmetric, with most of one wing (the upper lobe) 214 above the longitudinal line and most of the other wing (the lower lobe) 216 below the longitudinal line, allowing the physiological monitoring device to be placed diagonally on the heart such that when the patient is in a standing position, the position of the lower lobe is below the heart.

[0144] Electrode traces 218 extend outward from the housing and are contained on or within the wings, similar to the electrode traces described in other parts of this specification, such as with reference to Figure 1AAs described in other parts of this specification, the electrode traces can be printed directly on the flexible substrate, which can be part of the multi-layer flexible assembly 220. The additional printed lines 222 can surround the electrode traces 218 for visual enhancement of the physiological monitoring device. However, the printed lines 222 can also be printed on a layer different from the flexible substrate on which the electrode traces are printed. The printed lines can be printed to blend with the shape of the electrode traces. As explained in other parts of this specification, the electrode traces can surround a series of breathing holes 224 that allow air to flow to the underlying hydrogel. In embodiments, there can be one, two, three, four, or more breathing holes. As explained in other parts of this specification, the holes 232 can extend through one or more layers of the physiological monitoring device to provide breathability and moisture management. In embodiments, the adhesive border layer 228 can extend outward from the wings, thereby allowing improved adhesion. Figure 2B shows Figure 2A the underside of the physiological monitoring device 200 shown in Figure 2B . Here, the lower housing 206 is clearly visible, and the electrode traces 218 and the printed lines 222 extending outward from the housing are also clearly visible. Figure 2C and Figure 2D shows Figures 2A to 2B the physiological monitoring device 200, which here includes an outer-facing top pad 226 covering the wings and surrounding the middle housing 202 and a release pad 230 facing the patient's skin. Such a release pad is used to protect the physiological monitoring device 200 during storage, especially the adhesive surface of the physiological monitoring device. In embodiments, the shape of the pad can cause the two sides to intersect to form an opening for the housing to extend vertically through the pad.

[0145] In some embodiments, before adhering the physiological monitoring device 200 (as described in other parts of this specification) to the patient, an abrader can be used to abrade the patient's skin. An abrader can be used to remove the patient's superficial skin to improve the long-term adhesion of the physiological monitoring device and / or the signal quality emitted from the physiological monitoring device.

[0146] In various alternative embodiments, the shape of a particular physiological monitoring device can vary. For example, the shape, coverage area, perimeter, or boundary of the device can be circular, oval, triangular, a compound curve, etc. In some embodiments, the compound curve can include one or more concave curves and one or more convex curves. The convex shapes can be separated by concave portions. The concave portions can be located between the convex portions on the housing and the convex portions on the electrodes. In some embodiments, the concave portions can at least partially correspond to hinges, hinge regions, or regions of reduced thickness between the body and the wings.

[0147] Although described with a heart monitor as an example, the device improvements described herein are not limited thereto. The improvements described in this application can be applied to any of a variety of physiological data monitoring, recording, and / or transmitting devices. The improved adhesion design features can also be applied to devices that can be used for electronically controlled and / or timed release delivery of pharmaceuticals or blood testing, such as glucose monitors or other blood testing devices. Accordingly, the descriptions, characteristics, and functions of the components described herein can be modified as needed to include specific components for a particular application, such as electronic devices, antennas, power sources or charging connections, data ports or connections for downloading or offloading information from the device, adding or offloading fluids from the device, monitoring or sensing elements (such as electrodes, probes, or sensors), or any other components required for the specific functions of the device. Additionally, or alternatively, the devices described herein can be used to detect, record, or transmit signals or information related to signals generated by the body, including but not limited to one or more of an ECG, EEG, and / or EMG. In certain embodiments, additional data channels can be included to collect additional data, such as device motion, device bending or bedding, heart rate, and / or ambient electrical or acoustic noise.

[0148] The physiological monitor described above and the physiological monitors described in other parts of this specification can also be combined with methods and systems for data processing and transmission to improve the data collection of the monitor. Additionally, the methods and systems described below can improve the performance of the monitor by being able to transmit clinical information in a timely manner while maintaining the high patient compliance and ease of use of the monitor described above. For example, the methods and systems for data processing and transmission described in this section of this document or other parts of this specification can be used to extend the battery life of the monitor, improve the accuracy of the monitor, and / or provide other improvements and advantages described in this section of this document or other parts of this specification.

[0149] Figures 3A to 3H An example of a physiological monitoring device 300 is shown, similar to the physiological monitoring device described in U.S. Patent No. 11,350,864, the entire content of which is incorporated herein by reference. Figure 3APerspective view of a physiological monitoring device. The physiological monitoring device 300 may include wings 330, 331, both of which are asymmetric about a longitudinal axis that extends generally between electrode interface portions 302 that cover electrodes located on the underside of the wings. Electrode traces 304 may extend from the housing to the electrodes to provide electrical communication between the electrodes and the intermediate housing. One of the wings 330 may include a body that is disproportionately distributed above the longitudinal axis, and the other wing 331 may include a body that is disproportionately distributed below the longitudinal axis. Thus, wings 330, 331 may render the flexible body asymmetric about a transverse axis that is perpendicular to the longitudinal axis and extends through the housing 306, which may include a patient trigger 307, similar to other patient triggers disclosed elsewhere in this section of this document or other parts of this specification. As described elsewhere in this document, in certain embodiments, the patient trigger may encompass from about 10% to 30% of the total top area, such as about 20% of the top area; or about 23% of the total top area, such as about 22.8% of the total top area. In certain embodiments, the patient trigger may encompass more than about 20%, more than about 30%, more than about 40%, more than about 50%, or more than about 75%. In certain embodiments, the patient trigger may encompass the entire top surface of the housing. Wings 330, 331 may include the same shape, which is reversed or flipped about the longitudinal axis and the transverse axis as Figures 3A to 3C shown. In some embodiments, the size and shape of the wings may be asymmetric, such that the upper wing 330 may be larger than the lower wing 331, and vice versa. The shapes of wings 330, 331 may be different such that the relative shape of the upper wing 330 is different from the relative shape of the lower wing 331. In certain embodiments, the upper wing 330 may experience greater tension than the lower wing 331, and vice versa, so the different sizes and shapes between the two wings may help address unique force vector issues during use of the physiological monitoring device. The configuration of the wings may be particularly suitable for arranging the electrodes in a diagonal pattern relative to the height of the individual, which may reduce peeling due to gravity. Those skilled in the art will understand that the orientation of the wings may be changed such that the wings are mirror images rather than disproportionately distributed above or below the longitudinal axis. Additionally, those skilled in the art will understand that, as described herein, such wing shapes may be different from the Figures 3A to 3H generally circular shape shown. For example, the wings may be angular, such as square, rectangular, triangular, pentagonal, or any suitable polygon. These polygonal shapes may have rounded corners to reduce the likelihood of peeling from the corners. Prior to applying the physiological monitoring device to a patient or user, a pad 308, such as shown elsewhere in this document, may be used to cover and protect any adhesives. In an embodiment, the pad may be split into two parts, one on each wing.

[0150] In some embodiments, an additional visualization pattern 310 may extend through the wing. The visualization pattern 310 may be any suitable size or shape to outline the electrode traces and the shape of the wing. For example, the visualization pattern 310 may be in the form of a line, such as a circular line, to reflect the outer shape of the electrode traces and the shape of the wing. In some embodiments, there may be one line, two lines, three lines, four lines, or more lines. In some embodiments, the visualization pattern may be formed by dots, shapes, or other combinations of patterns to maintain the visual cleanliness of the device when the originally transparent adhesive layer becomes less visually acceptable to the user during the entire wearing process (e.g., if the adhesive layer adsorbs foreign matter and / or becomes cloudy due to moisture absorption). In some embodiments, the visualization pattern may have another functional purpose, i.e., to remind the user of the time they have worn the device by changing color over time or with wear. Such an appearance change can remind the user to remove the device at the correct time. Figure 3B Top view showing an example of the physiological device 300, Figure 3C showing the bottom view, Figure 3D1 showing the side view. In Figure 3C it, the flexible electrode 312 is visible. As Figure 3D1 shown, the upper housing 314 and lower housing 316 portions of the housing can be located above and below the flexible body 318. Figure 3E And Figure 3F show the lower side and upper side of the physiological monitoring device 300, each layer being transparent such that all layers are visible. Each layer will be described in more detail in the exploded view of the physiological monitoring device 300. The holes 320 may be located in the base layer above the adhesive layer. As described in more detail above, such holes can provide breathability through one or more layers and can facilitate the evaporation of moisture from below the adhesive layer through the one or more layers including the holes. As Figure 3D2 shown, in an embodiment, the gasket 319 may be located between the upper housing 314 and the lower housing 316. The gasket 319 may be co-molded into one or more of the housings. The gasket may press down on the adhesive assembly and the ridged interface (as Figure 3D2 shown below), or may press on another gasket on the opposing housing to provide waterproofing for the internal electronic hardware. As shown in Figure 3B2, the ridge 321 may be located on the upper edge of the lower housing 316. The ridge 321 is configured to press into the adhesive layer 336. Those skilled in the art will understand that the ridge 321 may be any suitable shape, such as the edge ridge 321 as shown. In some embodiments, the ridge may be circular, square, and / or polygonal. In some embodiments, the height of the ridge may be about 0.01 mm to 0.5 mm, about 0.05 mm to 0.4 mm, about 0.1 mm to 0.3 mm, about 0.1 mm to 0.2 mm, or about 0.15 mm, such as about 0.13 mm.

[0151] Figure 3G A exploded view showing an example of the flexible body 301 of the physiological monitoring device 300 described in this section of the present text and other parts of this specification. The housing 306 is not shown. Those skilled in the art will understand that Figure 3G the image in [reference] is inverted with respect to the positioning on the skin. According to Figure 3G the numbering in [reference], #7 shows the release liner protecting the adhesive layer 340 and the hydrogel electrode 350. Directly above the adhesive layer is a perforated layer (containing holes as described herein) 344 and a flap layer 303. In some embodiments, the perforated layer and the flap layer can be made of any suitable material, such as polyethylene terephthalate (PET) and / or polyurethane. Directly above the perforated layer can be a lower base layer #1, which can be made of polyurethane. In an embodiment, the lower base layer can have at least one textured side, and this side can be positioned such that the textured side faces the flap layer #3. In an embodiment, the flap layer #3 can also at least include a textured side. This textured side can be configured to face the lower base layer #1. Conductive electrode traces can be printed on additional separate substrates (311, 312). Alternatively, in some embodiments, the conductive electrode traces can be printed directly on the base layer #1. Above the conductive electrode traces can be an upper base layer 334. Above the upper base layer can be an additional carrier layer #10, then an adhesive layer #11 and the topmost rigid liner #9. Those skilled in the art will understand that such a layer arrangement can be applicable to any embodiment of the physiological monitor described herein, such as Figures 3A to 3F the embodiment of [reference].

[0152] Figure 3HA exploded view showing an example of the housing 306 of the physiological monitoring device 300 is presented, with the flexible body 301 passing through the housing 306 as described above. The upper housing cover 314 may include a patient trigger 307. Additionally, the upper housing cover 314 may encase the circuit board 322. A gasket 323 located beneath the circuit board is configured to maintain a consistent spacing between the conductive contact springs on the lower side of the circuit board and the battery terminals / ECG trace contacts. The gasket may also additionally provide electrical insulation between the circuit board and the battery. The gasket may have holes to allow the conductive contact springs to pass through, and the contact springs are connected to the circuit board. The battery terminals 325 may be located beneath the flexible body 301 and the circuit board 322, thereby covering the wave spring 326. In an embodiment, the battery terminals 325 may wrap around and adhere to the coin cell battery 328. The battery terminals 325 may be constructed as a flexible circuit having conductive vias 327 that enable the lower side of the positive electrode of the coin cell battery 328 to be connected to the upper side of the negative electrode of the battery, such that both the negative and positive terminals are located on the upper side of the battery to meet the circuit board contact springs. Alternatively, one or more battery contacts in the bottom housing may connect the lower side of the positive electrode of the coin cell battery to the upper side of the negative electrode to contact the circuit board. The ventilation layer 329 may be placed against the lower housing 316, above the ventilation holes 332 in the lower housing. In an embodiment, the ventilation layer may be composed of a material that blocks the passage of liquid while allowing the passage of gas, such as ePTFE or any other suitable material. The ventilation holes 332, in combination with the ventilation layer, allow the air pressure between the outside and inside of the housing to normalize. In an embodiment, the ventilation holes 332, in combination with the ventilation layer, prevent the buttons and / or trigger 307 from being blown out or sucked in according to the external air pressure (e.g., if the patient is at a different altitude (e.g., on an airplane)). The ventilation layer may be thin and circular, with an annular structure adhesive at the bottom. The area of the ventilation layer coated with the adhesive may be airtight, while the central portion may be breathable but liquid-impermeable. The central portion of the ventilation layer may be located above the ventilation holes, thereby allowing gas to enter and exit the housing while restricting the entry and exit of liquid. In some embodiments, the ventilation layer may be integrally molded into the bottom housing, or may also be ultrasonically welded to the bottom housing, or adhered in any suitable manner.

[0153] Physiological monitoring device

[0154] Now refer to Figure 4Embodiments are provided. According to one embodiment, a schematic diagram of a sensor platform 1050 is provided. In some embodiments, the ECG and / or PPG sensor platform components may include the hardware 1052 and software 1054 aspects of the sensor platform. In some embodiments, the hardware aspect of the sensor platform may include an ECG and / or PPG sensor 1056 and a blood pressure reference 1058. In some embodiments, the blood pressure reference 1058 may measure the patient's data and be used as a reference for further blood pressure measurements. For example, a patient may use a blood pressure device to measure blood pressure and input the blood pressure data into a wireless application, and the sensor platform 1050 may access and compare the currently measured blood pressure as a baseline. Additionally, the software components of the sensor platform can be used to perform diagnostic analysis using the data collected from the hardware components. In some embodiments, the software components of the sensor platform may include filtering and peak detection 1060, calculation of pulse transit time (PTT) or pulse arrival time (PAT) 1062, and regression analysis 1064. In some embodiments, such calibration can be performed using a separate third-party system.

[0155] In an exemplary embodiment, filtering and peak detection 1060 may be the first step in preprocessing the data collected from the hardware of the sensor platform. For example, filtering may include software enabled filtering of data, such as a bandpass filter, a Kalman filter, or other comparable filtering processes. Peak detection may include software implemented identification of the maximum or minimum values from the ECG sensor and / or PPG sensor. The calculation of PAT 1062 may include identifying the peaks from the peak detection process and using the ECG sensor data and PPG sensor data to identify an estimated PAT for each heartbeat. Regression analysis 1064 may be a software implemented trend prediction technique to correlate the physiological signals from the sensor platform with other characteristics of hemodynamics and / or the user's blood flow or stroke volume. In some embodiments, the system may track the behavior change of this correlation with sensor values, blood pressure values, or time. The sensor platform may be configured to identify the regression analysis using regression techniques such as a linear regression model, a best fit regression model, time-based regression, multiple regression, or any other suitable regression technique. The embodiments are described in a certain order. Figure 4 However, it should be understood that different orders or configurations of software elements and hardware elements may be applied.

[0156] Now referring to Figure 5A 、 Figure 5B and Figure 5C Embodiments are provided, a schematic diagram of at least one embodiment is provided. InFigure 5A In, the schematic diagram 1100 may include an overview of a device that includes a sensor platform 1102 (such as Figure 4 the sensor platform 1050 disclosed in) to collect data and identify physical or physiological characteristics of a user wearing the device. In one embodiment, the sensor platform 1102 may be worn on the chest of the user as shown. In other embodiments, the sensor platform 1102 may be worn on other parts of the user's body. In some embodiments, the sensor platform 1102 may include at least one ECG sensor 1104 and at least one PPG sensor 1106. In some embodiments, at least one ECG sensor 1104 and / or PPG sensor 1106 may be embedded in an adhesive patch that makes physical contact with the user. In some embodiments, there are more than one ECG sensor 1104 and / or more than one PPG sensor 1106.

[0157] In Figure 5B In, the schematic diagram 1110 may include an embodiment of the reflective properties of the PPG sensor 1106 on the device. In some embodiments, the PPG sensor 1106 may include a transmitter 1106A and a detector 1106B. For example, the transmitter 1106A and the detector 1106B respectively emit wavelengths of the electromagnetic spectrum to the user's body and receive the reflected wavelengths of the electromagnetic spectrum. In some embodiments, the system may evaluate the received signal to track the amount of light reflected back to the detector modulated by the pulsatile blood flow through the user's blood vessels. The tracked amount of reflected light may correspond to hemodynamic information. In some embodiments, the difference in the wavelength spectra of the transmitted and received signals of the electromagnetic spectrum may correspond to the physical properties of the blood traveling through the user's body, which may also correspond to the user's heart mass or condition.

[0158] In Figure 5CIn [the figure], the schematic diagram 1120 may include an exemplary calculation of PAT, which may be related to the user's blood pressure. In some embodiments, PAT may be calculated based on data collected from the ECG sensor 1104 and the PPG sensor 1106. For example, the sensor platform 1102 may detect peaks from the ECG data of the ECG sensor 1104 and the PPG data of the PPG sensor 1106. The sensor platform 1102 may measure the ECG p wave, measure the PPG valley and / or trough, the inflection point along the rising systolic blood pressure, determine the weighted center of gravity of each pulse, etc. The ECG data may correspond to the electrical signal for heart pumping, and the PPG data may correspond to the mechanical pumping of the heart. The peak measurement difference between the ECG signal and the PPG signal generally corresponds to PAT. The value of PAT may correspond to the user's blood pressure. PAT may be inversely proportional to the user's blood pressure. In some embodiments, the sensor platform 1102 may measure the time between the peaks identified in the ECG data and the PPG data to calculate PAT. In some embodiments, the left axis of the figure may include the ECG values on the ECG measurement 1122, and the right axis may include the PPG values on the PPG measurement 1124. The estimated blood pressure may be calculated from the peaks detected by each sensor.

[0159] Now referring to Figure 6 the embodiment of [the figure], which provides a schematic diagram of the device 1200 according to one embodiment. This embodiment may be similar to the embodiments described above in FIGS. 1 to 5, and several aspects may be the same as those in FIGS. 1 to 5. In some embodiments, the device 1200 may include at least one photoplethysmogram sensor (PPG sensor) 1202, a flexible optical electrode trace 1204 connected to the microprocessor 1206, and at least one ECG sensor 1208. In certain embodiments, such a device may capture one or more ECG signals and one or more PPG signals to provide comprehensive health information. Similar to FIGS. 1 to 5 described above, the wing may be flexible and may provide conformal contact with the individual's skin, which may prevent at least one PPG sensor 1202 from peeling or lifting off the skin, thereby providing strong motion artifact suppression and better signal quality by minimizing the transmission of stress to at least one PPG sensor 1202. In addition, in some embodiments, the device 1200 may include a flexible body (e.g., Figure 1A the flexible body 110), which is located in a configuration with various features, which helps the patient to comfortably wear the device 1200 for fourteen (14) days or longer without removal.

[0160] In some embodiments, the PPG sensor 1202 may include at least one light-emitting diode (LED) (e.g., LED 1202A) and a photodiode (PD) (e.g., PD 1202B). Thus, the LED 1202A and the PD 1202B may be collectively referred to as the PPG sensor 1202. At least one LED 1202A may illuminate the user area where the device 1200 is located, such that the signal received by the PD provides information about the physiological characteristics of the user's body or blood flow.

[0161] In some embodiments, the system may include multiple LEDs. For example, one of the LEDs 1202A may illuminate the user's body with infrared light, and another LED (not shown) may illuminate the user's body with red light, such that the PD can sense the reflected light from the user's body, including both infrared light and red light. In some embodiments, the system may include one or more LEDs and one or more photodiodes.

[0162] In certain embodiments, the reflected light (e.g., from infrared light, green light, red light, or other light) may correspond to the user's oxygen saturation, heart rate, respiration, and / or blood pressure. By using dual-wavelength PPG, where the two wavelengths are in different parts of the hemoglobin absorption spectrum, the user's oxygen saturation can be derived. In some embodiments, compared to deoxyhemoglobin, one wavelength of light may be absorbed to a greater extent by oxyhemoglobin, while the other wavelength of light may be absorbed to a greater extent by deoxyhemoglobin rather than oxyhemoglobin. One of the wavelengths may also be absorbed to an equal extent by both oxyhemoglobin and deoxyhemoglobin. The ability to measure the user's oxygen saturation has applications in monitoring sleep apnea and other respiratory diseases. In some embodiments, the ECG sensor 1208, the microprocessor 1206, or other processors may convert the reflected light from the analog signal into a digital value. The ECG sensor 1208 may transmit the analog value or digital value to the microprocessor 1206 via the flexible optical electrode trace 1204. In some embodiments, the PPG sensor 1202 may convert the reflected light from the analog signal into a digital value. The PPG sensor 1202 may transmit the analog value or digital value to the microprocessor 1206 via the flexible optical electrode trace 1204. In another embodiment, at least one LED 1202A and / or PD 1202B may follow the power limit for long-term user wear. For example, at least one LED 1202A and / or PD 1202B may follow a power limit such that the device 1200 can be worn by the user for 14 days or longer without being removed.

[0163] In some embodiments, the PPG sensor 1202 may always maintain contact with the user while collecting data. For example, the adhesive wings connected to the patch (e.g., Figure 1AThe PPG sensor 1202 of the flexible body 110) therein can maintain sufficient contact to acquire PPG data. In some embodiments, the PPG sensor 1202 can measure data from the user's chest. The PPG sensor 1202 connected to the adhesive wing of the patch can provide sufficient optical coupling for the PPG sensor 1202. In other embodiments, the device 1200 has no specific requirements for the position placed on the user. In some embodiments, the PPG sensor 1202 can be disposed on the lower side of the housing including the microprocessor 1206. The PPG sensor 1202 in this embodiment can always maintain or not maintain contact with the user's skin. The PPG sensor 1202 and / or the device in this embodiment can include or can not include an adhesive connection component.

[0164] In some embodiments, the microprocessor 1206 may receive digital values determined at the PPG sensor 1202. In other embodiments, the microprocessor 1206 may receive an analog signal containing information about the reflected light from the user's body via the flexible optical electrode trace 1204. In some embodiments, the microprocessor 1206 may combine the values from the PPG sensor 1202 with the values from the ECG sensor 1208. In some embodiments, the ECG sensor 1208 and the PPG sensor 1202 may collect data simultaneously and transmit the data values to the microprocessor 1206 simultaneously. When the microprocessor 1206 combines these values, the result can be used to calculate the user's blood pressure. In some embodiments, the microprocessor 1206 calculates physical parameters based on the data. For example, the microprocessor 1206 may calculate blood pressure based on the relationship between the peak of the PPG digital value and the ECG digital value. The relationship between the peaks may correspond to the Pulse Arrival Time (PAT). For example, the microprocessor 1206 may detect peaks from the ECG data of the ECG sensor 1208 and the PPG data of the PPG sensor 1202. The ECG data may correspond to the electrical signal for heart pumping, and the PPG data may correspond to the mechanical pumping of the heart. The difference in peak measurements between the ECG signal and the PPG signal generally corresponds to the PAT. The value of the PAT may correspond to the user's blood pressure. The PAT may be inversely proportional to the user's blood pressure. In some embodiments, the microprocessor 1206 may measure the time between the peaks identified in the ECG data and the PPG data to calculate the PAT. In another embodiment, the microprocessor 1206 may transmit the data collected from the ECG sensor 1208 and the PPG sensor 1202 to a computer or server for further processing. In another embodiment, the data (and / or its derived signals) from the ECG sensor 1208 and the PPG sensor 1202 may be downloaded from the microprocessor 1206 and uploaded to a computer or server for further processing. For example, the microprocessor 1206 may determine the peaks, and the computer or server may determine the user's blood pressure.

[0165] In some embodiments, the processing of data from the ECG sensor 1208 and the PPG sensor 1202 may include filtering and peak detection, calculation of PAT, and regression analysis. In one embodiment, the microprocessor 1206 may filter the digital signals from the ECG sensor 1208 and the PPG sensor 1202 using a high-pass filter or another type of filtering method. In another embodiment, the microprocessor 1206 may calculate the PAT using the relationship between the data collected from the ECG sensor 1208 and the data collected from the PPG sensor 1202 or the relationships between multiple PPG sensors. In certain embodiments, the relationship between the PAT metric and blood pressure may be inversely proportional. In another embodiment, the microprocessor 1206, computer, or server may calculate the regression trend of the data collected from the ECG sensor 1208 and the PPG sensor with a physiological reference (such as blood pressure). The regression trend may be calculated based on linear regression or any other regression analysis technique. In some embodiments, the microprocessor 1206, computer, or server may use regression analysis and then directly estimate the blood pressure value from the ECG and / or PPG sensors.

[0166] Typical PAT measurements of ECG and PPG sensors use physically separated sensors on the patient's body. For example, the ECG sensor is located on the patient's chest, while the PPG sensor is located on the user's finger. The present invention presents an embodiment that allows PAT measurements from the ECG and PPG sensors to be made close to each other. For example, both the ECG and PPG sensors can be located on a device on the patient's chest. The wearable device and / or other computing device may determine the delay between the ECG and PPG. Such a delay may be related to the user's blood pressure. For example, the ECG signal may include an electrical signal indicating the heartbeat, and the PPG may include a mechanical signal of the physical pumping of blood through the blood vessels. These two signals inherently have a delay (because the electrical signal travels faster than the mechanical signal).

[0167] In some embodiments, the ECG sensor 1208 and the PPG sensor 1202 may be close to each other without placing one of the sensors on the user's limb. For example, the ECG sensor 1208 and the PPG sensor 1202 may be placed on the user's chest and provide data collection only from the chest position. In some embodiments, the ECG sensor 1208 and the PPG sensor 1202 collect data from blood vessels. The wearable device is configured to measure the voltage potential through the electrodes of the heart (including the sinoatrial node and / or atrioventricular node) circuit. In addition, the PPG sensor 1202 may collect data from arteries, veins, and / or capillaries.

[0168] Figure 7Embodiments provide a schematic diagram of a device 1300 according to one embodiment. In some embodiments, device 1300 may include a flexible patch 1302 having a PPG sensor 1304 and a flexible optical electrode cable 1306. One advantage is connecting the PPG sensor 1304 to the flexible patch 1302 to improve user comfort. Another advantage of directly integrating optics in the adhesive is to improve the connection between the optical sensor and the skin, thereby improving the PPG signal quality. In certain embodiments, connecting the PPG sensor 1304 to the flexible patch 1302 may enable a user to wear device 1300 for an extended period of time without discomfort. In some embodiments, the flexible patch 1302 may include a silicone adhesive material to allow device 1300 to be attached to a user's body.

[0169] In some embodiments, a wearable device may include an impedance sensor (not shown in the figure). The impedance sensor may include an electrical sensor. In some embodiments, the impedance sensor and the ECG sensor may use different electrodes and / or share at least a subset of the electrodes. The impedance sensor can be used to reduce noise in the acquired analog signal (e.g., if the impedance sensor is used to detect movement), which can improve the accuracy of data acquisition measurements. The impedance sensor can also or alternatively be used for impedance cardiography (ICG), such as measuring the conductivity of the torso and / or changes in the torso to derive cardiac dynamics parameters including stroke volume and / or aortic valve opening time. The time of aortic valve opening can be used to help improve the accuracy of the PAT metric when estimating blood pressure.

[0170] In some embodiments, the small size of the PPG sensor 1304 generally helps to provide conformal contact with the individual's skin and the flexible electrode cable 1306 by moving the PPG sensor away from the microcontroller and other electronic components (such as a battery, an analog front end), which can help prevent the PPG sensor 1304 from falling off or detaching from the skin, thereby providing strong motion artifact suppression and better signal quality by minimizing the transfer of stress to the PPG sensor 1304. Additionally, device 1300 may include configurations and various features that help a patient wear device 1300 comfortably for fourteen (14) days or longer without removal. The components of device 1300 also allow the flexible patch 1302 to bend freely. The flexible optical electrode cable 1306 can also be thin and flexible to allow the patient to move without signal distortion.

[0171] Now referring to Figure 8 embodiments of Figure 8Schematic diagram of an optical sensor 800 according to one embodiment is provided. In some embodiments, the optical sensor 800 may include at least one LED 1402, at least one photodiode (PD) 1404, a capacitor location 802, a flexible printed circuit (FPC) cable 804, and a cable end 806. A key advantage is that the form factor of the device (such as the device 1300 in Figure 7 ) is reduced while improving the device performance. In one embodiment, at least one LED 1402 may include a monochromatic or multi-color LED. For example, at least one LED 1402 may include a green LED with a wavelength of 525 nm. In another embodiment, the PD 1404 may include a commercial off-the-shelf PD capable of detecting visible light changes. In some embodiments, the distance between at least one LED 1402 and the PD 1404 may depend on the wavelength of at least one LED 1402. For example, the distance between at least one LED 1402 and the PD 1404 may be less than 10 mm. In some embodiments, the distance between at least one LED 1402 and the PD 1404 may depend on the desired penetration depth of light into the skin or body. In one embodiment, the optical sensor 800 may include a capacitor located at the capacitor location 802. The capacitor can be used to decouple the noise caused by other circuits (which can be picked up along the long FPC cable) from the analog signal of interest. In other embodiments, the optical sensor 800 does not have a capacitor in the capacitor location 802. In some embodiments, the flexible printed circuit cable 804 may be an optical cable, which can allow electrical signals to be transmitted from at least one LED 1402 and the PD 1404 to the FPC connector where the FPC cable end 806 is inserted.

[0172] Now referring to Figure 9 the embodiment of Figure 9 Schematic diagram of a user blood pressure reference according to one embodiment is provided. The figure may also include a blood pressure graph 902 and a heart rate graph 904. Each graph may include a first plurality of segments 906 indicating moderate impedance training. Each graph may include a second plurality of segments 908 indicating difficult impedance training. In some embodiments, the user's blood pressure measured using various measurement techniques may have a corresponding user heart rate during exercise. For example, when the user exercises with a moderate resistance band, the user's heart rate and blood pressure may correspond to a moderate activity baseline. In another embodiment, when the user exercises with a difficult resistance band, the user's heart rate and blood pressure may correspond to a difficult resistance baseline. During each exercise, the user's heart rate and blood pressure may be greater than the baseline determined when the user is at rest.

[0173] Now referring toFigure 10A and Figure 10B Example, a schematic diagram of a user's ECG data and PPG data is provided according to one example. In some examples, a user may wear a device (e.g., Figure 7 device 1300 in), the device includes a sensor platform, the sensor platform includes at least one ECG sensor and at least one PPG sensor. The sensor platform may collect data when the user performs various activities. Referring to Figure 10A example, the first figure 1000 shows the data collected from each ECG sensor and PPG sensor, which may correspond to the physical mass of the user's heart, such as the electrical signal driving the heart to pump (i.e., ECG data) and the mechanical pumping of the heart (i.e., PPG data). Referring to Figure 10B example, the second figure 1010 shows the use of ECG data and PPG data, where the device may identify the first peak of the ECG data 1012 and the second peak of the PPG data 1014 in each heartbeat data collected. Then the device may use the peaks (or in post-processing) to identify cardiac features, such as the pulse arrival time (PAT) 1016 and estimate blood pressure.

[0174] Now referring to Figure 11 example, Figure 11 A schematic diagram of the change of a user's PAT over time is provided according to one example. In some examples, a device (e.g., Figure 7 device 1300 in) may be used to measure the PAT. In some examples, the device (or in post-processing) may cross-reference the PAT with the user's heart rate to determine the accuracy of the measurement. For example, when the heart rate is at a trough, the PAT may be at a maximum, and conversely, when the heart rate is at a peak, the PAT may be at a minimum.

[0175] Now referring to Figure 12A example, Figure 12A is an example of an electrode for measuring thoracic impedance or conductivity according to one example. The device may include a non-invasive sensor for measuring the electrical signal of the chest. For example, the device may use internal electrodes 1222 / 1224 and / or external electrodes 1226 / 1228 to measure the total conductivity. The device may measure the total conductivity by driving a current between the external electrodes 1226 / 1228 and measuring the voltage between the internal electrodes 1222 / 1224. Figure 12ATwo internal electrodes 1222, 1224 and two external electrodes 1226 / 1228 are shown. However, it should be understood that the device may have only internal electrodes, only external electrodes, different numbers of electrodes, different numbers of sets of internal / external electrodes, etc. The device may measure the change of an electrical signal (such as total conductivity) over time. The device may apply these measurements to derive cardiac dynamics parameters, such as stroke volume, cardiac output, and pre-ejection period.

[0176] In some embodiments, a high-frequency, low-amplitude current (I) may be applied between electrodes on the chest (e.g., between two electrodes). The electrodes may be arranged parallel to the spine. The resulting voltage signal (V) may be recorded through the two electrodes. The impedance Z may be calculated based on the current I and the voltage V. For example, the impedance Z may be calculated by Z = V / I. The current generally seeks the path of least impedance, which may mainly include the blood-filled aorta.

[0177] Now referring to Figure 12B the embodiment of Figure 12B is an electrode embodiment for measuring the conductivity of the thoracic cavity and an ECG sensor according to an embodiment. The device may include electrodes for impedance (e.g., two internal electrodes 1222 / 1224 and two external electrodes 1226 / 1228) and electrodes for ECG (such as electrodes 1252, 1254). The device may use sensing electrodes shared with the embodiment electrodes. The sensor may be arranged at specific positions, angles, and / or minimum or maximum separations of the electrodes. The signals emitted by the electrodes may be set to specific amplitudes and / or frequencies.

[0178] In some embodiments, impedance may be used to utilize drive and sense electrodes. In a four-electrode configuration, there may be two external drive electrodes and two internal sense electrodes. In a two-electrode configuration, the signal is driven and sensed by the same set of electrodes. In either configuration, the impedance sensing electrodes may be shared with the ECG sensing electrodes. Thus, the electrode configuration may include multiple electrodes, such as two, four, or six electrodes.

[0179] In some embodiments, impedance may be acquired along a vertical vector (parallel to the up-and-down nature of the aorta). ECG may be acquired at an angle (e.g., a 45-degree angle) for measurements on the heart. Impedance electrodes may be disposed above and / or below the heart. ECG electrodes may be disposed on the left and / or right of the heart. For ECG data, the electrodes may be separated by a greater distance above the heart to produce better signal quality. For impedance, a greater separation distance may also be applied within the maximum distance where the wearable device can no longer resolve the cardiac pulsation waveform.

[0180] In some embodiments, the input signal has preferred amplitude and frequency values (e.g., the impedance drive signal is above 32 kHz and the current is about 100 μA to 1.5 mA).

[0181] Now referring to Figure 13A the embodiment of Figure 13A is an impedance cardiogram according to one embodiment. The device may derive the impedance based on a baseline component Z 0 and a time-varying component ΔZ. For example, ΔZ is expected to be about 0.5% of Z 0 . The impedance cardiogram (ICG) may be the first derivative of ΔZ. In Figure 13A , A is atrial contraction, B is aortic valve opening, C is maximum systolic flow, X is aortic valve closing, Y is pulmonary valve closing, O is mitral valve opening, and LVET is left ventricular ejection time.

[0182] Now referring to Figure 13B the embodiment of Figure 13B is a diagram determined according to one embodiment of the pulse arrival time. PAT is the pulse transit time, PEP is the pre-ejection period, and PTT is the pulse conduction time. PAT includes the time between the electrical initiation of systole and the start of left ventricular ejection (PEP). The impedance cardiogram (ICG) is important because it can estimate blood pressure using the propagation characteristics of the arteries. The ICG can be used to measure the blood pressure from the opening of the aortic valve to the arrival of the pressure pulse at the distal vessels. PEP varies with changes in blood pressure, especially after short-term exercise.

[0183] Examples related to skin connection

[0184] Figure 14A Shows a cross-sectional view of Embodiment 1440 of an optical transparent adhesive under a photodiode and an LED according to some embodiments. Figure 14BA top view 1450 of an optical transparent adhesive beneath a photodiode and an LED according to some embodiments is shown. The adhesive assembly can be used to adhere a physiological monitoring device to a patient. Embodiment 1440 can include a photodiode 1404, an LED 1402, a flexible circuit 1406 (such as a polyimide flexible circuit), a brightness enhancement film 1408A, a brightness enhancement film 1408B, a brightness enhancement film 1408C (collectively referred to herein as brightness enhancement film 1408), and an optical transparent adhesive layer 1410. The optical transparent adhesive layer 1410 can be joined and adhered to the user's skin. Since the adhesive layer 1410 is optically transparent, the optical transparent adhesive layer 1410 can be directly adhered to the LED 1402 and the photodiode 1404. Advantageously, the LED and the photodiode can be well-connected to the user's skin. In some embodiments, the brightness enhancement film 1408 can be disposed at other locations, such as within the flexible circuit 1406, or the brightness enhancement film 1408 can cover part or all of the flexible circuit 1406, extending beyond the flexible circuit 1406, etc. The brightness enhancement film 1408 can be integrated with an adhesive that is disposed above the flexible circuit 1406 and applies pressure to the flexible circuit 1406 and applies the brightness enhancement film 1406 to the patient's skin. The brightness enhancement film 1408 and / or the optical transparent adhesive layer 1410 can include any type of biocompatible and skin-friendly brightness enhancement film and / or adhesive. Additionally, the brightness enhancement film 1408 and / or the optical transparent adhesive layer 1410 can include any type of brightness enhancement film and / or adhesive that does not interfere with or enhances the transmission of optical signals. Some non-limiting examples of films or adhesives that can be used in certain embodiments described herein include 3M TM 's Vikuiti TM Brightness Enhancement Film (BEF) III, Vikuiti TM -Enhanced Specular Reflector (ESR) and Contrast Enhancement Film (CEF) 19XX series optically transparent adhesives.

[0185] In some embodiments, embodiment 1440 includes a brightness enhancement film 1408 that can refract and / or reflect light to enhance light output. Accordingly, light that would otherwise be absorbed by the device and not penetrate the skin can now be reflected from the brightness enhancement film 1408 and penetrate the skin. Additionally, light reflected from the skin that is not directed towards the photodiode can also have another chance by being reflected from the brightness enhancement film 1408 and returning to interact with the skin and be reflected back to the photodiode. Advantageously, light that would not otherwise be absorbed by the opaque barrier may have another chance to be reflected towards the skin or the photodiode. The brightness enhancement film 1408 can be disposed between optical elements, between an optical element and the skin, below the opaque layer of the flexible plate, and / or at a location where light can be reflected. The embodiments described herein include the brightness enhancement film 1408. However, it should be understood that other reflectors or materials that recycle photons can be used. For example, the brightness enhancement film 1408 can be integrated with an optically clear adhesive and / or an enhanced specular reflector, the brightness enhancement film 1408 can be placed near an optically clear adhesive and / or an enhanced specular reflector, and / or the brightness enhancement film 1408 can be replaced with an optically clear adhesive and / or an enhanced specular reflector.

[0186] In some embodiments, the brightness enhancement film 1408 is flush with the photodiode and / or the LED. In other embodiments, the brightness enhancement film 1408 is elevated towards the circuit 1406 such that the void space between the photodiode and the LED provides room for the skin to tent.

[0187] In some embodiments, an adhesive can surround one or more optical elements, such as an LED or a photodiode. The adhesive can be applied between optical elements, such as between an LED and a photodiode. The adhesive can include an optically clear adhesive. The optically clear adhesive can be applied to one or more optical elements, such as all LEDs and photodiodes.

[0188] In some embodiments, one or more wicking materials can be integrated with the adhesive, one or more wicking materials can be added to the adhesive, one or more wicking materials can be placed near the adhesive, or one or more wicking materials can replace the adhesive. The wicking materials can include a polyester type material that can help absorb and / or evaporate substances such as goop or sweat. The wicking materials can be placed around the optical elements or intertwined with the adhesive.

[0189] In some embodiments, a hydrophilic material can be placed around the optical elements to attract fluid and pull the fluid away from the optical elements. A hydrophobic material (e.g., between the LED and the PD) can also be placed to keep fluid away from the optical elements.

[0190] In some embodiments, a light-emitting component can be used to emit light, and a light-detecting component can be used to detect light. For example, the light-emitting component can include an LED or an electroluminescent panel. The light-detecting component can include a photodiode.

[0191] In some embodiments, the LED and the photodiode are located in a separate portion of the device rather than the portion that holds the electrodes. For example, the LED and the photodiode can be secured to the patient's skin with a different adhesive than the adhesive that holds down the electrodes. Figure 6 It is shown that the optical components 1202A, the optical component 1202B, and the ECG sensor 1208 are placed on different parts of the body with the same adhesive but in different parts of the same adhesive.

[0192] In some embodiments, the optical components can be secured by different parts of the same adhesive or by an adhesive different from the ECG sensor. Advantageously, since the adhesive only needs to secure a smaller-sized component (e.g., only the optical component rather than a larger rigid housing that houses the optical component and the electrodes), the optical components can have a better connection on the skin.

[0193] In some embodiments, the optical sensor and the electrodes are located on the same flexible wing. Advantageously, the device can have a smaller footprint than a device with separate flexible wings. In some embodiments, the optical sensor and the electrodes are located on separate flexible wings. Advantageously, having separate flexible wings can improve the signal quality by reducing crosstalk between the ECG signal and the PPG signal. Additionally, having separate flexible wings can provide the option to place the PPG sensor on the chest at a different and better location than the optimal location of the ECG sensor (e.g., a location with denser blood vessels).

[0194] In some embodiments, at least a portion of the traces for the electrodes is parallel to at least a portion of the traces for the optical sensor. Advantageously, by reducing the area used by the traces on the flexible wing, and thus making the occupied area on the flexible wing smaller, an electronic device (e.g., a device including the flexible wing) can have a smaller occupied area. For example, the parallel trace portions start from the housing that houses the circuit and the battery.

[0195] In some embodiments, the electronic device includes a first electrode, a second electrode, a first adhesive, and a second adhesive. The first adhesive is configured to hold the first electrode on the patient's skin. The second adhesive is configured to hold the second electrode and one or more optical sensors on the patient's skin. The first adhesive and the second adhesive are physically separated to prevent a shorted pathway of electrical conduction between the two electrodes. The first adhesive may hold a first flexible wing on the patient's skin, and the second adhesive may hold a second flexible wing on the patient's skin. In some embodiments, the electronic device may include three adhesives. The first adhesive may hold the first electrode on the skin, the second adhesive may hold the second electrode on the skin, and the third adhesive may hold one or more optical components on the skin. In some embodiments, more adhesives may be used, such as a fourth adhesive, to hold other optical components on the skin. In some embodiments, a single adhesive may hold multiple components, such as multiple electrodes.

[0196] In some embodiments, the electronic device is configured to attach and detach an optical sensor to and from the device. The optical sensor may be disposable and replaceable. The device may be used and modified to work with only the electrodes, only the optical sensors, or both simultaneously. For example, the optical sensor and the trace may be connected to the electronic device by connecting the end of the trace to a connector on the housing. The detachable optical sensor may include its own adhesive, separate from the adhesive of the electrodes.

[0197] Figure 15A Embodiment 1500 showing indentation into a patient's skin according to some embodiments is illustrated. In Embodiment 1500, the wearable device may include one or more LEDs 1504A, LED 1504B (collectively referred to herein as LEDs 1504) and a photodiode 1502. The LEDs 1504 may be indented into the user's skin 1506. In Embodiment 1500, two LEDs 1504A, LED 1504B may be indented into the skin at different points of the skin. The skin may be tented, for example, maintaining a triangular or tentlike appearance when clamped from both sides by the LEDs 1504. The LEDs 1504 may emit light into the tented area, and the photodiode 1502 may collect the emitted light from the tented area. The tented area may include a region of tissue rich in blood vessels. Advantageously, transmitting signals through the tented area may obtain higher signal quality by passing completely through the region of tissue rich in blood vessels.

[0198] Although the embodiments show certain components as LEDs, electrodes, or photodiodes, it is understood that forFigure 15A And in other figures in this document, these components can be switched, flipped, replaced, and / or exchanged with other components (e.g., switching an LED to a photodiode, and / or vice versa).

[0199] Figure 15A Example 1500 of [the device] shows a wearable device, where the wearable device extends beyond LED 1504 away from the area configured to create a depression on the skin, and the extended area is configured to be flush with the patient's skin. Thus, the wearable device can include a flush surface and / or a flat surface having the depression where the detector 1502 is located.

[0200] Figure 15B Example 1520 shows the use of two extended portions of the wearable device pressed into the patient's skin. Figure 15B Example 1520 of [the device] shows a wearable device, where the wearable device does not extend beyond LED 1504 away from the area configured to create a depression to be flush with the patient's skin, but retracts from the peak where LED 1504 is located. The wearable device can include a protrusion where LED 1504 is located and a depression where LED 1504 is not, e.g., the location where the photodiode is located, or the end of the LED farther from the central raised area.

[0201] In some embodiments, the wearable device can include multiple LEDs, such as LED 1504A, LED 1504B. Advantageously, more light can be emitted to the raised area for the photodetector to detect. More light can interact with the blood, so the photodiode can receive more blood-related information. In other embodiments, a single LED 1504A can be used. The wearable device can be pressed into the skin on one side rather than both sides by a single LED.

[0202] In some embodiments, LED 1504 can be configured to emit light directionally into the raised area of the skin. In some embodiments, the LED can be a directional LED that emits light in a specific direction. Advantageously, the LED can focus the light in a certain direction and minimize or eliminate the light that would otherwise be emitted from the raised area.

[0203] In other embodiments, LED 1504 can emit light in multiple directions, and additional materials can be used to block or redirect the light. For example, an opaque layer can block the light emitted in the opposite direction of the raised area, or a reflective layer can be used to reflect the light emitted in the opposite direction of the raised area to give it another chance to be emitted in the direction of the skin raised area. In addition, the opaque layer can block the ambient light noise from an external source from affecting the LED and / or the photodiode.

[0204] In some embodiments, a one-way film or material that allows light to be emitted in one direction can be applied. For example, the material can be placed on an LED or a photodiode, adjacent to an LED or a photodiode, or near an LED or a photodiode. The light emitted by the LED can be directed towards the material, and the material can allow the light to pass through while blocking the light from the other side of the material. Similarly, for a photodiode, the light from the body can pass through and reach the photodiode, while blocking the light from the other side of the material.

[0205] Figure 15C Embodiment 1540 showing the application of an optical cable for emitting light to a user's skin or a skin depression according to some embodiments is shown. In some embodiments, the optical cable or light guide can focus light onto the user's skin. Embodiment 1540 can include a backing layer 1510, such as a polyimide backing layer that can include a flexible or conventional PCB board. LEDs 1504 can each be connected to light conduits 1508A, light conduits 1508B (collectively referred to herein as light conduits 1508) to direct light to one side of the protrusion so as to press into the skin. The LEDs 1504 can be placed on the backing layer 1510. Advantageously, manufacturing is improved by enabling the LEDs to be placed directly on a flat plate while allowing the light to penetrate the raised area (where the raised area rises from the backing layer).

[0206] In some embodiments, the light conduit can be made of a material having a specific refractive index or the light conduit can be coated with a material having a specific refractive index, such as an optimal index matching between two of the following: LED, air, skin, lens, etc. For example, the light transmitted into the skin can be transmitted from the LED to the user's skin using light with a good refractive index match. The light conduit can achieve a high percentage of light transmission. In some embodiments, the light conduit can have a small diameter to achieve better flexibility.

[0207] In some embodiments, the light conduit 1508 can include one or more opaque layers on a portion of the light conduit. The opaque layer can prevent light from being emitted in certain portions of the light conduit 1508. The portion that emits light into the skin raised area can not include the opaque layer. In some embodiments, the opaque layer can be placed adjacent to the optical component, near the optical component, or between the optical components.

[0208] In some embodiments, a cup or dome made of or covered with an opaque layer may be placed over one or more optical components. In some embodiments, the opaque layer may be in the form of a gasket, a ring, a cylinder with a hollow center, etc. surrounding the optical sensor. Advantageously, the opaque layer may prevent ambient light or crosstalk from causing noise in the electrical signal.

[0209] In some embodiments, the backing layer may include a flexible PCB. The flexible PCB may be warped to have protrusions and / or depressions to form depressions on the skin and / or to form raised areas of the skin. Advantageously, the LEDs and / or photodiodes may be positioned closer to the raised areas while still being manufactured to be placed on the backing layer.

[0210] In some embodiments, the flexible sheet can bend during use to conform to the curvature of the user's skin. The flexible sheet can be thinner than other sheets. This flexibility can allow it to better integrate with the patient's skin.

[0211] In some embodiments, the LEDs and / or photodiodes are disposed on a rigid board. Advantageously, the assembly is more stable, making the distance between the optical components less susceptible to variations. Additionally, a rigid board can improve skin indentation.

[0212] Figure 15A , Figure 15B and Figure 15C A cross-sectional view of an electronic device is shown. In some embodiments, the LED and / or the photodiode can be rectangular in shape. In other embodiments, the LED and / or the photodiode can be circular. For example, the photodiode 1502 can be a sphere, a cylinder, an ellipsoid, etc.

[0213] In some embodiments, LED 1504A, LED 1504B may be a portion of a single LED in a donut shape or annular shape. The LED shape may include a single LED in a donut shape or annular shape and / or may include a plurality of LEDs forming a donut shape or annular shape. In some embodiments, the LED or photodiode may be an incomplete donut shape or annular shape, wherein only a certain percentage or portion of the LED is in a donut shape or annular shape. For example, the LED may be in a 120 degree, 180 degree, 220 degree, 260 degree, or 300 degree donut shape, with the remaining area not including the LED. Advantageously, the incomplete portion may alleviate some of the squeezing that may occur due to the LED pressing into the skin.

[0214] Figure 16A top view of Embodiment 1600 according to some embodiments is shown, for redirecting, minimizing, or eliminating sweat or other mucus (such as dirt, grease, bacteria, or other bodily secretions or effluents) in an electronic component. Embodiment 1600 may include a photodiode 1602, LEDs 1604A, 1604B, 1604C, 1604D, and a channel 1606. The channel 1606 may allow sweat to escape and / or evaporate. The channel 1606 may include a microfluidic channel for the escape and / or evaporation of sweat or mucus collected under a groove, depression, or raised area, or an optical sensor.

[0215] In some embodiments, the channel 1606 may be placed between the LEDs and the photodiode. The channel 1606 may be placed in the same plane as the LEDs and the photodiode. In some embodiments, the LEDs, photodiodes, and / or other components may have a coating with a divot next to the component, such that sweat or mucus can drain. In some embodiments, the adhesive for fixing the electronic device to the skin may include grooves or channels for the escape of sweat or mucus. In some embodiments, the backing layer (such as a flexible PCB) may include built-in channels for the escape of sweat or mucus. In some embodiments, the backing layer may be a wicking material and / or a breathable material to help promote the evaporation of sweat.

[0216] Figure 17 Embodiment 1700 according to some embodiments is shown, which has a contact portion for applying pressure to the LED and / or photodiode for better connection to the skin. Embodiment 1700 may include a contact portion 1704, which may include a recessed portion and a protruding portion, such as a protruding portion 1705, a backing layer 1706, and an LED or photodiode 1702. The protruding portion 1705 may contact the LED or photodiode 1702 at a certain contact point. In some embodiments, the contact portion may include an opaque barrier material. Advantageously, the contact portion may serve a dual role of applying pressure and blocking light from piercing through the contact portion.

[0217] In some embodiments, the device is configured such that the user presses on the housing and / or other parts of the device when the device is collecting measurements. For example, the user may initiate the determination of biometrics and / or the device may indicate to the user that the device is starting up or suggest that the user initiate the determination of biometrics (such as through an LED or sound, or a message on an application), and then the user will subsequently fix the device such that the sensor can better connect to the skin to measure an ECG signal and / or a PPG signal.

[0218] In some embodiments, the contact point can be a single point or area on top of an LED or photodiode 1702. Advantageously, the force applied by the contact portion 1704 to the LED or photodiode 1702 can be greater than the force of the backing layer 1706 pressing directly on the LED or photodiode 1702. The force of the contact portion 1704 applies pressure over the contact area that is more targeted than the force of the backing layer pressing down on the LED or photodiode 1702, as the backing layer is applying pressure on the contact portion and that pressure is being transmitted to the optical sensor at the contact point. The backing layer 1706 can include a semi-rigid backing layer that indirectly applies a downward pressure on the electronic components towards the skin 1708.

[0219] In some embodiments, the electronic device can include wicking material near the contact area where the contact portion presses against the LED or photodiode. Advantageously, the wicking material can prevent sweat from forming or pooling in the contact area.

[0220] Figure 18A Embodiment 1800 is shown that uses physical barriers to prevent adhesive or mucus from spilling onto an electronic device according to certain embodiments. Embodiment 1800 can include a backing layer 1802, an optical component 1804 (such as a photodiode), adhesives 1806A, 1806B (collectively referred to herein as adhesives 1806), and physical barriers 1808A, 1808B (collectively referred to herein as physical barriers 1808). After prolonged use of the wearable device, the adhesive 1806 may begin to leak from below and may leak onto other electronic components, such as the optical component 1804. This mucus (such as an adhesive or an adhesive mixed with sweat or other body excretions or effluents) may leak under the LED or photodiode, thereby blocking the emission or detection of light signals. The physical barrier 1808 can block the adhesive from spilling onto electrical components such as LEDs or photodiodes. The physical barrier can separate the sensor from the adhesive or mucus. In some embodiments, an adhesive having properties that prevent or mitigate mucus formation can be used.

[0221] In some embodiments, the physical barrier 1808 is tilted towards the adhesive, further reducing the potential amount of adhesive leaking towards the electronic components. The physical barrier 1808 also prevents the adhesive from contacting the electronic components (such as LEDs or photodiodes) before being applied to the user. The physical barrier 1808 can include a rigid structure next to the adhesive. The physical barrier 1808 can include a thin film adjacent to the adhesive. The physical barrier 1808 can include a non-sticky surface.

[0222] Figure 18BEmbodiment 1850 shows a single LED and / or multiple LEDs in an annular shape or a toroidal shape according to certain embodiments. Embodiment 1850 may include an LED 1852 in a toroidal shape or an annular shape. The LED 1852 in a toroidal shape or an annular shape may emit light towards the center of the toroid or the annulus and towards the detector 1854. In certain embodiments, the LED may illuminate an illumination conduit in a toroidal shape or an annular shape. The illumination conduit may emit light in the direction of the photodiode.

[0223] Figure 19 Embodiment 1900 shows an LED emitting light of different wavelengths according to certain embodiments. Embodiment 1900 includes an LED 1902 that may emit light of one wavelength (e.g., green light) and another LED 1904 that may emit light of another wavelength (e.g., red light). The LED 1902 and the LED 1904 may emit light of different wavelengths in a raised area, and the photodiode 1906 may detect the light from the two LEDs.

[0224] In some embodiments, the detector may simultaneously detect the light from the two LEDs, where the light is emitted at different wavelengths. In some embodiments, the LED may emit light along multiple wavelengths or along a spectrum focused near a specific wavelength. In certain such cases, the wearable device may be configured to filter the light of the first wavelength emitted from the first LED to remove the second wavelength that may correspond to the light emitted from the second LED.

[0225] In some embodiments, such filtering may be performed through signal processing, such as a frequency filter or a physical filter on the photodiode. For example, if green light is emitted from the left and red light is emitted from the right, the first photodiode may include a physical filter for the passage of green light on the left, and the second photodiode (or the same first photodiode) may include a physical filter for the passage of red light on the right.

[0226] In some embodiments, the first LED may emit light, the detector may detect the light of the first wavelength from the first LED, then the second LED may emit light and the detector may detect the light of the second wavelength from the second LED.

[0227] Figure 20 Embodiment 2000 shows a repeating LED and photodiode according to certain embodiments. The LEDs 2004A and 2004B may emit light to the left and to the right, and the photodiodes 2002A, 2002B, and 2002C may detect the emitted light. The LEDs 2004A and 2004B may emit light to the raised area between the LEDs. The LED may include a bidirectional LED that emits light in two directions, such as to the left raised area and to the right raised area or an omnidirectional LED.

[0228] Figure 21 Embodiment 2100 showing different adhesives for a wearable device according to some embodiments. Embodiment 2100 may include a photodiode 2104 and LEDs 2102A, 2102B having a variety of adhesives, such as a first adhesive or inner adhesive 2106 closer to the electronic components and a second adhesive or outer adhesive 2108 on the outside.

[0229] In some embodiments, the first adhesive and / or the second adhesive may include openings or slits that can provide flexibility with patient movement. If the slits are arranged along the vertical axis and the user movement generates tension along the horizontal axis, the adhesive can stretch more horizontally. The openings or slits can help reduce movement on the housing or components, or can isolate the sensor from user movement.

[0230] In some embodiments, the different adhesives may have different degrees of stickiness. For example, the stickiness of the first adhesive 2106 may be less than that of the second adhesive 2108, and vice versa. The outer adhesive 2108 may be a load-bearing adhesive that is thicker than the inner adhesive 2106. The thicker adhesive can conform to the body better, provide moisture, and be warmer to the skin, but may have more adhesive goop than the inner adhesive 2106.

[0231] In some embodiments, the inner adhesive 2106 may be thinner, optically clearer, less sticky, and form less mucus than the outer adhesive 2108, and the outer adhesive 2108 may be harder, etc. In some embodiments, the wearable device may have only the outer adhesive 2108 without the inner adhesive 2106, and vice versa. Advantageously, the electronic components can be protected from the mucus escaping from the adhesive.

[0232] Figure 22A Embodiment 2200 showing a single LED and a single photodiode according to some embodiments. The single LED 2202 can emit light towards the single photodiode 2204. Figure 22B Embodiment 2220 showing an LED array and a photodiode array according to some embodiments. An array of LEDs 2202A, 2202B, 2202C, 2202D (collectively referred to herein as the LED array 2202) can emit light towards an array of photodiodes 2204A, 2204B, 2204C, 2204D (collectively referred to herein as the photodiode array 2204).

[0233] Figure 22CEmbodiment 2240 showing LEDs and photodiodes distributed in a circular array according to some embodiments. The LEDs 2202 can emit light towards the center of the circular array, and the photodiodes 2204 can detect light from the center of the circular array. The structure of embodiment 2240 can be such that a skin raised area can be formed within the circle for light penetration. The LEDs and photodiodes can be alternated around the circular array. Advantageously, any photodiode can pick up the light from all the LEDs emitting towards the same raised area of the skin. A wearable device (or other computing device) can add the signals collected from the photodiodes to produce a stronger signal strength. In some embodiments, the computing device can time-align the received signals before adding the collected signals.

[0234] Figure 23A Embodiment 2300 showing a protrusion with a lighting channel according to some embodiments. Embodiment 2300 includes an LED 2302, a photodiode 2304, and lighting channels 2306A, 2306B. The lighting channel or light guide can receive the light emitted by the LED and direct the light through lighting channel 2306A. Lighting channel 2306A can cause the light to be emitted from the LED side to the photodiode side. The lighting channel 2306B on the photodiode side can capture the light emitted from the LED side and transfer the light to the photodiode 2304. In some embodiments, the LED and / or the photodiode includes a lighting channel and / or is integrated with a lighting channel. Directing the light can result in a greater proportion of the emitted light being directed from the LED 2302 to the photodiode 2304, or passing through the skin between the LED 2302 and the photodiode 2304.

[0235] Figure 23B Embodiment 2350 showing the use of a ring or light guide according to some embodiments. Embodiment 2350 includes a plurality of LEDs 2302A, 2302B, a photodiode 2304, and light guides 2306A, 2306B. Each LED can have its own light guide to direct the light from the LED to the patient's skin, such as a raised area of the skin. The photodiode 2304 can capture the light emitted from the plurality of light guides 2306A, 2306B, which can be collectively referred to as light guide 2306.

[0236] Figure 24Example 2400 is shown in which a leaf spring presses down on certain components of a wearable device. Example 2400 includes a rigid portion 2406 that applies pressure to an LED 2402 and a photodiode 2404. The conformable portion of the wearable device may include a flexible portion 2408A that may be non - sticky, a flexible portion 2408B, and adhesive layers 2410A and 2410B on both sides. The rigid portion may include a leaf spring to apply a force downward toward the LED and the photodiode. Advantageously, the rigid portion may apply a force on the LED and the photodiode to improve the connection of the LED and the photodiode to the skin. Improving the connection to the skin may include increasing the contact between the LED and / or the photodiode and the skin. Additionally, applying pressure or force on the LED and / or the photodiode toward the skin may improve the signal quality or may be adjusted to achieve better or optimal signal quality. It should be understood that the present invention is not limited to leaf springs, and other types of springs or mechanical devices may be used to apply a force downward toward the LED and / or the photodiode.

[0237] Figure 25 Example 2500 is shown of a bowl - shaped flexible circuit that is pressed into the skin. Example 2500 may include LEDs 2502A, 2502B, a photodiode 2504, adhesives 2508A and 2508B on the sides, and a backing substrate 2506. The backing substrate 2506 may be bowl - shaped or inwardly recessed to naturally apply pressure to the LEDs and the photodiode, thus providing a better connection to the skin. In some cases, the backing substrate 2506 is fixed to the flexible circuit and pressure is applied to the flexible circuit to improve the connection of LEDs 2502A, 2502B and photodiode 1504 to the patient's skin. In some embodiments, the backing substrate 2506 may include protrusions that naturally apply pressure in one direction. The user's skin or movement may apply pressure in another way, but the protrusions may withstand a certain amount of pressure without losing their protrusion shape while continuing to apply pressure to the skin.

[0238] Figure 26A Example 2600 is shown of an opaque barrier between an LED and a photodiode. Example 2600 may include LEDs 2602A, 2602B, a photodiode 2604, and opaque barriers 2606A, 2606B, collectively referred to as opaque barrier 2606. As light is emitted from the LED 2602 to the raised area 2608 of the skin, the opaque barrier 2606 may block the light from passing directly from the LED 2602 to the photodiode 2604. In some embodiments, the opaque barrier 2606 is closer to the LED than to the photodiode.

[0239] In some embodiments, the LED may include a lens to direct light to a specific area, such as a raised area of the skin. For example, the lens may have a rough surface that does not point to the raised area of the skin, while the surface pointing to the raised area of the skin may be transparent, so that the light from the LED can be emitted toward the raised area of the skin. The rough surface can create a tortuous path for light emitted in an undesired direction.

[0240] Figure 26B Embodiment 2650 showing a pseudo - transmission from an LED directly to a photodiode through a raised area of the skin according to certain embodiments. This embodiment includes an LED 2652 and a photodiode 2654 located between raised areas 2656 of the skin. The skin is tented due to the pressure exerted by the LED and the photodiode on the sides of the skin. The optical signal can be emitted from the LED 2652 and pass directly through the skin to the photodiode 2654, thus improving the signal strength compared to conventional reflected signals. Additionally, the LED and the photodiode can be placed on elevated structures 2658A, elevated structure 2658B, such as a rail, to press into the skin, thereby further forming more raised areas in the skin.

[0241] Figure 27A A cross - sectional view 2700 showing an embodiment using a bundle of optical fibers for an LED and a photodiode according to certain embodiments. Figure 27B A side view 2750 showing an embodiment using a bundle of optical fibers according to certain embodiments. A first bundle of optical fibers 2702 may be connected to one or more LEDs, and a second bundle of optical fibers 2704 may be connected to one or more photodiodes.

[0242] In some embodiments, the light emitted from the LED can be emitted through the first bundle of optical fibers 2702 and enter the user's skin 2706. The light can be reflected from the skin and received by the second bundle of optical fibers 2704 and then transmitted back to the photodiode. The electronic device presses into the user's skin 2706 to form a depression in the skin. In certain embodiments, the optical fibers slightly press into the skin. In other embodiments, the optical fibers are adhered to a flat surface that rests against the skin. In some embodiments, the optical fibers are spaced apart by a certain distance, such as 1 cm, 0.5 cm, 0.25 cm, etc.

[0243] In some embodiments, the LED and the photodetector can share the same optical fiber channel. For example, the fiber bundle can be woven into the same optical fiber channel such that a single - bundle channel can be separated at one end to be connected to the LED and the photodetector, and the other end is connected to a layer 2708 in contact with the skin. In some embodiments, the optical fiber channel can have an inner core for the LED and an outer core for the photodetector.

[0244] In some embodiments, the LED and the photodetector use the same channel. For example, when the LED emits light, the optical fiber channel is used for the LED, and when the photodetector detects light, the switch switches the optical fiber channel to the photodetector.

[0245] In some embodiments, the electronic device includes an accelerometer for taking into account the motion situation. For example, if high motion is detected, the electronic device can discard the reading. The electronic device can also remove noise caused by motion, such as if the motion has a specific frequency.

[0246] In some embodiments, a specific input pulse signal or signal feature can be transmitted to the LED. At the photodetector, the emitted light is detected, and the processor looks for the specific input pulse signal or signal feature input into the LED. Applying such a filter, such as a matched filter, can significantly improve the signal-to-noise ratio of the received signal.

[0247] In some embodiments, the ECG sensor and the PPG sensor are far apart, for example, one is on the chest and the other is on a finger or a toe. The received ECG sensor data and PPG sensor data can be received by the same circuit, which can make time synchronization easier. As further disclosed herein, the circuit can estimate the time delay for providing blood pressure information. The signal propagates fast enough such that the time delay is not greater than the pulse length.

[0248] Skin connection examples

[0249] Figure 28A Embodiments of skin connection by two dome-shaped composites are shown according to certain embodiments. For example, skin connection can be made between the device 1200 and the patient's chest. In addition, skin connection can be made between the flexible wings (such as wing 330 or wing 331) of the device (such as device 300) and the patient's chest. The skin connection embodiment 2800 can include an LED 2802, a detector 2804, two dome-shaped composites 2806A, 2806B (collectively referred to herein as dome-shaped composites 2806) and / or an opaque barrier 2812. The dome-shaped composites 2806 can be in a hemispherical shape. The dome-shaped composites 2806 can extend from the LED 2802 and the detector 2804 to the patient's skin surface 2810. The dome-shaped composites 2806 can include composites such as glass lenses to transmit optical signals. The dome-shaped composite 2806A can be in the shape of a dome or a convex lens to direct light from the LED 2802 to the skin, and / or the dome-shaped composite 2806B can be in the shape of a dome to direct light from the skin back to the detector 2804.

[0250] In some embodiments, the skin attachment embodiment 2800 includes an opaque barrier 2812. One of the potential drawbacks of positioning the LED 2802 and the detector 2804 close together is potential crosstalk of the optical signals, where at least a portion of the optical signal travels directly from the LED 2802 to the detector 2804 without passing through the skin. For the crosstalk signal, the detector 2804 does not detect a signal containing any physiological information. The opaque barrier 2812 can be included to block the signal from traveling directly from the LED 2802 to the detector 2804.

[0251] Although the skin attachment embodiment 2800 includes the opaque barrier 2812, it should be understood that other barriers that block optical signals can be used. For example, one or more barriers that absorb stray light and / or reflect such light can be applied to limit the direct propagation of light from the LED to the photodetector. One or more barriers can be configured to funnel and / or direct the angled light to the photodetector. In some embodiments, the opaque barrier 2812 can extend beyond the LED 2802 and / or the detector 2804. In other embodiments, the opaque barrier 2812 can partially extend beyond the edges of the LED 2802 and / or the detector 2804 closest to the opaque barrier. For example, a dome can include circular and / or rounded portions that curve inward away from the opaque layer, and the opaque layer can fill gaps that would not otherwise be filled by a rectangular opaque barrier. In some embodiments, the opaque barrier 2812 can have different thicknesses and / or heights. In some embodiments, the opaque barrier 2812 can have a height below the top of the dome such that the opaque barrier reaches different points on the dome.

[0252] In some embodiments, the device can block unwanted signals or unwanted frequencies through a dome-shaped composite having certain light refraction or optical beamforming properties. The dome-shaped composite can direct or redirect light away from other optical components without a physical barrier corresponding to a specific frequency.

[0253] In some embodiments, the device can use certain substances to block unwanted signals, such as a silicone doped with a black dye to form a physical barrier. The substance can include a biocompatible epoxy resin (e.g., flexible when cured), which can be opaque or made opaque through dyes or other processes.

[0254] In some embodiments, the device can block unwanted signals based on the material thickness in the z-dimension of the opaque barrier. The opaque barrier can be at least at the height of the LED and the PD, but can also extend beyond the LED and / or the PD. If a dome-shaped composite is present, the opaque barrier can be at the height of the dome (e.g., as Figure 28A(in the embodiments shown), or along the height of the dome. The opaque barrier does not need to span / bridge the space between the LED and the PD. The dome may include a wire (e.g., an electrically insulating material) laid between the LED and the PD.

[0255] In some embodiments, the skin connection embodiment may include a reflective layer. For example, the reflective layer may be located next to the opaque layer. The portion of the opaque barrier 2812 that may contact the skin may have a reflective layer therebetween.

[0256] Advantageously, the light transmitted from the dome-shaped composite 2806A can be reflected by the reflective barrier rather than absorbed by the opaque barrier 2812. As the light is transmitted from the dome-shaped composite 2806A to the dome-shaped composite 2806B, the light reflected by the reflective barrier can improve the signal quality.

[0257] Figure 28B Another embodiment of skin connection via two dome-shaped composites is shown in accordance with certain embodiments. In the skin connection embodiment 2820, the two dome-shaped composites 2806 may be placed lower such that the dome-shaped composites are further pressed into the skin surface. In some embodiments, the two dome-shaped composites 2806 may have a greater length such that the dome-shaped composites are further pressed into the skin surface. In the skin connection embodiment 2800, the dome-shaped composite 2806 may include a curved surface, such as a dome shape. The amount of indentation of the dome-shaped composite into the skin surface may depend on various factors. For example, the amount of indentation may depend on whether the indentation will block smaller blood vessels near the surface, preventing these signals from being processed. The amount of indentation may depend at least in part on the amount of light transmitted from the LED to the detector and the associated hemodynamic information through interaction with the blood vessels, which may result in a larger and / or more accurate signal.

[0258] In some embodiments, the curved surface may be curved to a certain degree, such as 180 degrees. At least a portion of the curved surface may be configured to contact the patient's skin surface 2810. For example, in the skin connection embodiment 2800, a portion of the curved surface contacts the skin surface 2810 and another portion of the curved surface contacts the opaque barrier 2812. Advantageously, sweat can be trapped between the dome-shaped composite and the opaque barrier and / or on opposite sides of the dome-shaped composite. Other substances such as sweat help couple light in and out of the skin.

[0259] In another embodiment, the skin connection embodiment 2820 includes a curved surface, wherein the entire curved surface is configured to contact the patient's skin surface. One side of the cylindrical portion of the dome-shaped composite 2806 contacts the opaque barrier 2812. In this embodiment, the cylindrical portion of the dome-shaped composite 2806 is flush with the opaque barrier 2812. Advantageously, if other substances are undesirable, such as for cleaning (e.g., for a device left on the patient for many days), or if the substances disperse the signal rather than focusing the light onto the skin, other substances such as the user's sweat can be prevented from being trapped between the dome-shaped composite 2806 and the opaque barrier 2812. Other substances such as sweat or dirt may have an impact on refractive index matching. For example, due to the refractive index mismatch between the two materials, light may be deflected when entering and / or leaving the substance. Depending on the direction of the light from the LED to the skin or from the skin to the detector, the refractive index of the substance can be desirable or undesirable. Generally, substances with a refractive index similar to that of the skin, such as sweat, will help match the interface and limit the back reflection from the skin surface due to a severe mismatch.

[0260] In the skin connection embodiment 2820, the dome-shaped composite 2806 can be pressed more into the skin than in the skin connection embodiment 2800. Advantageously, the skin connection embodiment 2820 can result in more transmission-mode PPG-type signals that can be directly transmitted from the curved surface of the dome-shaped composite 2806A for the LED 2802 to the skin surface and through the dome-shaped composite 2806B for the detector 2804. Conversely, the skin connection embodiment 2800 can capture more reflection-mode PPG-type signals that are reflected back from tissue components (such as blood vessels) within the patient's body. In the skin connection embodiment 2820, the transmission-mode PPG signals can be used to capture more signals from superficial blood vessels. However, the reflection-mode and / or transmission-mode PPG signals can be used to detect more deep blood vessels. In some embodiments, both transmission signals and reflection signals can be present and can be used to generate more precise light signals and / or light signals that provide more information about different layers of skin tissue.

[0261] In some embodiments, a skin connection embodiment may include an optically transparent film or adhesive, which may include wavelength guiding properties that help redirect light to be more effectively transmitted from an LED to a detector. The waveguide properties may include polarization lenses that may allow light to pass through in a specific direction, for example, more from the LED towards the skin surface in the direction of the detector. Advantageously, less light may be lost in the other direction of the LED away from the detector. In some embodiments, other directional emission techniques may be used, such as phased array optical elements that control the transmission of light waves, reflect light waves, or capture the phase and / or amplitude of light waves on the surface. This adjustment of the phase and / or amplitude may be used to steer the direction of a light beam to a specific direction without any moving parts. Advantageously, the light beam may be steered in the direction of the LED to improve stronger signal detection at the detector. Additionally, on the receiving side, the detector may include a phased array optical detector that may obtain a stronger signal from the LED.

[0262] Figure 28C Embodiments of circuits 2840 and 2860 are shown in accordance with certain embodiments. Circuits 2840 and 2860 may include two photodiodes 2842 and 2844. In some embodiments, the system may include multiple LEDs or receivers. The circuit includes two receivers and one transmitter. The system may subtract or reduce noise from the circuit by rejecting common baseline information present on both receivers, which may include electrical noise (such as 60Hz noise). In some embodiments, one photodiode may serve as a reference signal for the amount of light power emitted to the skin, and the other photodiode may serve as a receiver diode. If the bandwidth of the power reference photodiode operational amplifier circuit is the same as that of the receiver photodiode, the reference photodiode signal may be compared with the receiver photodiode by a technique called autobalanced detection to cancel out power fluctuations in the LED output by approximately 1 / 3 bandwidth. Autobalanced detection can be very effective in eliminating common-mode noise to a very high degree, for example, if the fluctuation pattern of the LED output affects the extraction of the detector signal. The system may also improve the signal-to-noise ratio (SNR) of the signal by adding the AC components of the signals on the two receivers, which capture hemodynamic information from light interacting with blood vessels on both sides of a single transmitter, thereby increasing the sampled skin area. By using different geometric configurations of the receivers and transmitters, different regions of the skin may be sampled. The two receivers may also be placed at different distances from the transmitter, which will allow the signal to interact with different tissue depths and provide information about superficial and deep blood vessels. The two receivers may also contain different wavelength filters to capture more complex information about how light of different wavelengths interacts with vascularized tissue.

[0263] Figure 28D Illustrates a skin connection embodiment using a glass lens with an inwardly curved or concave shape according to certain embodiments. The skin connection embodiment 2880 may include an LED 2802, a detector 2804, an opaque barrier 2812, and inwardly curved glass lenses 2882, 2884. The detector 2804 may be a photodiode or any other type of optical detector. The inwardly curved glass lenses 2882, 2884 may be intentionally configured to capture other substances, such as saline or sweat, whose refractive index may match that of the outermost stratum corneum of the skin. Advantageously, the curved shape can allow for sufficient moisture on the skin to improve the light entering the skin. Additionally, when the device (e.g., device 1200 or device 300) is fixed to the user's skin (e.g., chest), the concave lens can cause the skin to tent towards the LED 2802 and the detector 2804 (e.g., photodiode).

[0264] Figure 29A Illustrates the use of a high refractive index material according to certain embodiments (e.g., skin connection embodiment 2900). For example, the refractive index of the material may be greater than 1.5, greater than 1.6, between 1.55 and 1.75, greater than 1.75, greater than 1.8, etc. The high refractive index material 2902 may include a curved shape and may match the refractive index of the stratum corneum. For example, the high refractive index material may be selected to have the same refractive index as the stratum corneum. The high refractive index material 2902 may be disposed below the optical element 2904 and may be used, for example, to form a dome or a curved or concave lens 2882, 2884 represented by the dome-shaped composite 2806. The optical element 2904 may include optical components such as an LED or a photodiode. The high refractive index material 2902 may include Figure 28D the inwardly curved glass lenses 2882 or 2884 in

[0265] Figure 29B Illustrates a dome-shaped composite that protrudes beyond an opaque barrier 2934, which overlaps at least a portion of the opaque barrier 2934 in a lateral direction and increases the contact area with the skin. The skin connection embodiment 2930 includes a dome-shaped composite 2932 that protrudes beyond the location where the opaque barrier begins. Advantageously, sweat is not trapped between the dome-shaped composite and the opaque barrier. Additionally, the shape of such a dome-shaped composite can allow light to be emitted below the opaque barrier, increasing the amount of light that can interact with the skin and be received by the detector.

[0266] Figure 29CIllustrates a ball lens embodiment according to certain embodiments. In some embodiments, the skin connection embodiment 2960 may include a complete circle, sphere, or ball 2962. The sphere 2962 may include a sapphire ball lens, which has the advantage of good refractive index matching with the skin. An adhesive 2964 for attaching an LED or a detector to the sphere 2962 may be applied to at least a part of the curved surface of the sphere 2962.

[0267] Figure 30A Illustrates a basic template of an LED and a detector mounted on a flexible circuit according to certain embodiments, where a waveguide can be constructed on the surface. Embodiment 3000 may include an LED 3002, a detector 3004, and a flexible circuit 3006. The flexible circuit 3006 may include a surface portion that can be connected to the patient's skin.

[0268] Figure 30B Illustrates an embodiment of a waveguide flexible circuit 3620 according to certain embodiments. A waveguide 3602A can be attached to the LED 3002 such that light emitted from the LED 3002 can flow through the waveguide 3602A. The detector 3004 may include a waveguide 3602B, whereby light can be captured through various regions and / or the entire waveguide 3602B and received at the detector 3004. The waveguide can be made of an adhesive polymer that is attached to the polyimide backing of the flexible circuit that holds the LED and the detector.

[0269] In some embodiments, the flexible circuit may include a 2D extension that tracks over a wider area of the skin portion (e.g., a wider portion of the user's chest). Using these waveguides, the system can include a smaller number of LEDs and / or detectors, such as Figure 30B 1 LED and 1 detector in, but having multiple data sources, such as effectively having 3 detectors and 2 LED light sources (detector 1 - light source 1 - detector 2 - light source 2 - detector 3). Additionally, the light transmitted from light source 1 to detector 1 may have a greater signal, but may penetrate the skin less deeply than the signal transmitted from light source 1 to detector 3. Signals sent from various light sources along the LED waveguide 3602A and / or signals received from various tracks along the detector waveguide 3602B can be combined to produce a stronger detection signal, or analyzed by separation distance to obtain more detailed information related to tissue depth.

[0270] Figure 30C Illustrates an embodiment of an adhesive for a dome - shaped glass lens according to certain embodiments. Embodiment 3040 includes an adhesive 3042 that adheres to the LED / detector and the dome - shaped glass lens. Figure 30DAn embodiment of an adhesive for an inverted dome shaped glass lens according to certain embodiments is shown. Embodiment 3060 includes an adhesive 3062 adhered to an LED / detector and an inverted dome shaped glass lens. An advantage of an inverted dome shaped lens is that the contact surface is flat to limit blanching of the skin. The LED and / or detector are bonded to the glass lens by an adhesive. The adhesive can be an assembly including an optically clear film, an optically clear adhesive, or a high refractive index resin or epoxy. The opaque barrier can then be backfilled in the surrounding area.

[0271] Figure 31A An embodiment of ray tracing of light emitted by an LED is shown in accordance with certain embodiments. Figure 31B An embodiment of ray tracing of detection light according to certain embodiments is shown. In embodiments 3100, 3120, light may be absorbed by opaque barrier 3104A, opaque barrier 3104B, reflected and guided from a wall, or directly injected into the skin. In embodiment 3100, light may be emitted from LED 3102A into glass lens 3106A. Light may be absorbed by opaque barrier 3104A and / or guided by reflecting from a surface to penetrate the skin and / or directly injected into the skin.

[0272] Light emitted from an LED (e.g., LED 3102A) and emitted from a glass lens (e.g., 3106A) to the skin can be scattered, reflected, and absorbed by the patient's body. The reflected light can be received on the detector side. In embodiment 3120, the light can be received by the glass lens 3106B and absorbed by the opaque barrier 3104B, and / or guided by being bounced off the surface and / or directly incident on the detector 3102B and received by the detector 3102B. Advantageously, if the LED and detector are placed on the chest surface, the LED can transmit light to the patient's chest, and some of the light can be reflected back after interacting with a large number of surface capillaries that feed the outermost layer of the skin and / or vascularize the outermost layer of the skin, and the detector can detect these signals. These signals can be used to determine blood pressure and other hemodynamic characteristics.

[0273] Figure 31C , Figure 31D , Figure 31E , Figure 31F and Figure 31G Shown are steps for forming different types of domes on LEDs and detectors according to certain embodiments. Figure 31C An embodiment of a flexible plate 3146, a circular base 3144, and an LED / detector 3142 are shown in accordance with certain embodiments. Figure 31D According to some embodiments Figure 31CTop view. The circular base 3144 can be placed on top of the flexible plate 3146. The LED / detector 3142 can be placed on top of the circular base 3144.

[0274] Figure 31E Shows an embodiment of adding a Teflon tube 3145 or a tube of other material according to certain embodiments. The Teflon tube 3145 can absorb and / or reflect signals entering the detector and / or emitted from the LED. Figure 31F Shows an embodiment of adding or forming a lens 3148 to be mounted within the Teflon tube 3145 and on the LED / detector 3142 according to certain embodiments. The lens 3148 can be fabricated by filling a mold with a UV-curable or other optically corrective adhesive and can be formed into the desired meniscus shape. The lens 3148 can scatter and / or direct light from the LED or direct light to the detector 3142. Using this method, the lens 3148 can be made thicker or thinner, for example, according to the desired indentation on the patient's skin. Figure 31G Shows that according to certain embodiments, an opaque barrier 3150 is added to the side of the Teflon tube 3145. The opaque barrier 3150 can prevent and / or mitigate crosstalk between the LED and the detector.

[0275] Figure 32 Shows a mold for forming an opaque barrier around a sapphire hemisphere glass lens according to certain embodiments. In this embodiment 3200, the flexible optical plate 3202 can include a flexible polyimide substrate. A photodiode (such as detector 3206) can be soldered to the flexible optical plate 3202. An LED (such as LED 3208) can be soldered to the flexible optical plate 3202. The sapphire hemisphere glass lens 3212 can be glued to the detector 3206 and the LED 3208. A barrier (such as an O-ring 3204) can be placed around the flexible optical plate 3202 such that when the material for forming the opaque barrier 3210 is injected or otherwise applied around the regions of the LED, detector, and hemisphere lens, the opaque barrier 32110 simply flows out from the right side. The filling amount of the opaque barrier 3210 can depend on how many glass nodes need to be exposed and / or in contact with the patient's skin.

[0276] Figure 33A Shows a fixture 3214 for clamping the O-ring 3204 according to certain embodiments. Figure 33B Shows according to certain embodiments Figure 33A Top view. Figure 33C Shows a side view and a cross-sectional view of the O-ring 3204 according to certain embodiments.

[0277] Figure 34A andFigure 34B and Figure 34C illustrates a prototype of a skin connection embodiment according to certain embodiments. Embodiment 3400 is an embodiment of a flexible optical plate, which may include a flexible printed circuit (FPC) cable 3402, an LED 3404, and a detector 3406. Figure 34B and Figure 34C illustrates an embodiment of applying different amounts of optical barriers according to certain embodiments. Figure 34B Embodiment 3420 of Figure 34C illustrates applying a smaller amount of optical barrier compared to embodiment 3440 of Figure 34B because the thickness of the optical barrier for

[0278] Figure 34D and 34E illustrates a skin connector in use according to certain embodiments. Figure 34D illustrates the light emitted from the LED, Figure 34E illustrates a user's finger on the LED. The detector is on the same side as the LED and detects the signals emitted from the LED, which pass through the body and are reflected back to the detector.

[0279] Figure 34F illustrates another embodiment of a skin connector, where the flexible optical plate can be directly placed on the chest surface, and the housing 3464 including the optical elements is fixed to the patient's skin using an adhesive 3462.

[0280] Figure 35A and Figure 35B illustrates embodiments of skin connection using conformal coatings according to certain embodiments. Figure 35A illustrates using a conformal coating of a certain thickness, Figure 35B illustrates using a conformal coating of another thickness. However, it should be understood that other thicknesses can be coated, such as thicknesses of 10μm, 20μm, 50μm, 100μm, 200μm, 500μm, 1000μm. The LED and photodiode protrude from the flexible optical layer, so the conformal coating on the LED and photodiode parts can electrically insulate between the optical elements and the user's skin and provide mechanical protection to soften any sharp edges of the optical elements. With a thin coating, the LED and photodiode can still be pressed into the patient's skin, such as the skin on the patient's chest.

[0281] The conformal coating can include optically transparent materials, electrically insulating materials, and / or biocompatible high finish epoxy. Advantageously, the conformal coating method enables the use of thinner materials, thus achieving a thinner form factor. Advantageously, the thinner form factor can enable better attachment of the optical element to the skin, for example, by seamlessly integrating it with an adhesive assembly. The thinner form factor may also require less force to apply sufficient pressure to the optical element to achieve adequate attachment to the skin. Additionally, with a thinner conformal coating, in the micron thickness range (e.g., 100 μm to 200 μm thickness), crosstalk between the LED and the detector is significantly reduced. Compared with using a large glass lens, the conformal coating does not direct light from the LED to the detector (or significantly reduces the amount of light directed). If the conformal coating is thin enough, considering the wavelength of the light and its horizontal transmission mode, the thin conformal coating layer can prevent (or significantly reduce) the amount of crosstalk between the LED and the detector. Since the conformal coating is thin, light can be reflected more, such that more light will ultimately penetrate the skin rather than be reflected back again to directly reach the detector without physiological contact. Conversely, if the conformal coating is thicker, the likelihood of light being reflected and transmitted to the other end of the conformal coating (e.g., adjacent to the detector) is higher.

[0282] Figure 36A Example 3600 shows how light is emitted from emitter 3602 to the skin of a patient according to certain embodiments. Figure 36B and Figure 36D Example shows a photodiode (LED) 3602, a detector 3604, and an epoxy bridge 3606A therebetween according to certain embodiments. The bridge 3606A in these embodiments is thicker than Figure 36C and Figure 36E The bridge 3606B shown in. Figure 36C and Figure 36E The bridge 3606B in shows an example where more epoxy in the bridge between the LED 3602 and the detector 3604 is removed, further reducing the likelihood of crosstalk between the LED 3602 and the detector 3604.

[0283] Advantageously, the conformal coating on all components helps protect the patient by applying the conformal coating on any exposed solder or exposed electrical contact pads. Additionally, the epoxy is biocompatible and is a single-layer surface layer rather than a multi-layer (e.g., having an opaque barrier and a glass lens). Further, having the LED directly emit light onto the skin through a thinner lens can provide more concentrated light than using a thicker or dome-shaped glass lens, which may disperse the light onto the skin and reduce the amount of light that has the opportunity to interact with the tissue of interest and reflect back to the detector.

[0284] In some embodiments, a biocompatible substrate, LED, and / or detector can be used such that a conformal coating may not need to cover the entire LED, photodiode, and / or substrate surface, or such that a thinner coating of the conformal coating may be required.

[0285] In some embodiments, the conformal coating helps to make the thickness of the devices around the LED and photodiode uniform. For example, the LED and photodiode can have different thicknesses. A conformal coating can be applied such that the thickness ratio of the LED and photodiode is closer than when no conformal coating is applied. Advantageously, when the device is placed on a patient's body, having a smaller varying thickness can help eliminate or reduce the air gap formed between the LED / detector and the patient's skin.

[0286] Figure 37A and Figure 37C A first embodiment showing a skin connection embodiment Figure 37B and Figure 37D A second embodiment showing a skin connection embodiment. Figure 37A and Figure 37C can have components different from Figure 37B and Figure 37D such as different LEDs or photodiodes. Figure 37A and Figure 37C The spacing between the photodiode and the LED in Figure 37B and Figure 37D is less than the spacing in

[0287] Figures 38A to 40B For example, the spacing between the photodiode and the LED can be 1 μm, 2 μm, 5 μm, 10 μm, 20 μm, 30 μm, 40 μm, 50 μm, 100 μm, 200 μm, 500 μm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 5 mm, 10 mm, a spacing between the above distances, etc. The spacing can be from the center of the LED to the edge of the photodiode. The LED can be a red LED, a green LED, an infrared LED, etc. The LED can emit light of a specific wavelength and / or a varying wavelength. The photodiode can measure light of a specific wavelength and / or a varying wavelength. Figure 14A and Figure 14B and the parts of the wearable device adhered to the patient's skin shown and described elsewhere in this document. The bonding assembly 3802 can include mating parts such as 3804A, 3804B, 3804C, 3804D, 3804E, 3804F (collectively referred to herein as the mating parts 3804). Figure 38A A front view showing the electronic component 3806 on the bonding assembly 3802 Figure 38BShows a perspective view thereof. Figure 38C Shows a perspective view of the electronic component 3806 cooperating with the bonding component 3802.

[0288] Figures 39A to 39D Shows another embodiment of the bonding component 3902 cooperating with the electronic device housing 3904 according to certain embodiments. The bonding component 3902 may include first mating portions 3906A, 3906B. The first mating portion 3906A may be configured to mate with a second mating portion 3908A on the electronic device housing 3904. In some embodiments, there is a single mating portion on the electronic device housing 3904 and / or the bonding component 3902. In some embodiments, there are multiple first mating portions on the bonding component 3902 and / or multiple second mating portions on the electronic device housing 3904. Advantageously, the adhesive can remain in place and the electronic device housing can be replaced for various reasons, such as for ease of use, battery access, data download from patches, etc. Additionally, the adhesive can be replaced while still using the same electronic device.

[0289] Figure 40A and Figure 40B Shows an embodiment of an electronic device housing cooperating with a bonding component according to certain embodiments. For example, Figure 40A and / or Figure 40B may include Figures 39A to 39D one or more embodiments thereof with a top cover for the housing. The electronic device housing 4004 may snap onto certain specific devices of the bonding component 4002. The electronic device housing 4004 may include LEDs and / or detectors for emitting and / or detecting light on a patient's skin.

[0290] Figure 41 Shows a diagram for determining ECG signals and PPG signals for PAT according to certain embodiments. PAT can be calculated as an integral according to the following formula:

[0291]

[0292] In some embodiments, ECG R peak to PPG peak information and / or ECG R peak to PPG foot / valley information can be used to calculate PAT. In other embodiments, the integral of the PPG signal can be used to calculate PAT by weighting the amplitudes of individual new samples.

[0293] Figure 42FIG. shows a diagram of using different integration intervals for calculating PAT as integration according to certain embodiments. In some embodiments, the system may integrate for each ECG heartbeat 4202 (the time period between ECG R-peaks) or for each PPG heartbeat 4206 (using the valley as the start / stop time). Advantageously, the PAT determination is more robust to noisy PPG signals because the determination does not rely on the precise determination of PPG peaks. One advantage of using ECG heartbeats is that calculating the integration for each ECG heartbeat provides additional robustness compared to noisy PPG data with different valleys or valleys that are difficult to precisely detect.

[0294] Each process, method, and algorithm described in the foregoing section can be implemented in code modules executed by one or more computer systems or computer processors including computer hardware and be fully or partially automated thereby. The code modules can be stored on any type of non-transitory computer-readable medium or computer storage device, such as a hard disk drive, solid-state memory, optical disc, etc. The systems and modules can also be transmitted on various computer-readable transmission media as generated data signals (e.g., as part of a carrier wave or other analog signal or digital propagated signal), including wireless-based media and wire / cable-based media, and can take various forms (e.g., as part of a single or multiplexed analog signal, or as multiple discrete digital data packets or frames). These processes and algorithms can be implemented partially or fully in dedicated circuits. The results of the disclosed processes and process steps can be persistently stored or otherwise stored in any type of non-transitory computer memory, such as volatile memory or non-volatile memory.

[0295] The various features and processes described above can be used independently of each other or can be combined in various ways. All possible combinations and sub-combinations are intended to fall within the scope of the present invention. In addition, in certain implementations, certain method or process blocks may be omitted. The methods and processes described herein are also not limited to any particular order, and the associated modules or states can be in an appropriate other order. For example, the described modules or states can be in an order different from the specifically disclosed order, or multiple modules or states can be combined into a single module or state. The example modules or states can be in series, in parallel, or in some other manner. Modules or states can be added to or deleted from the disclosed embodiments. The configurations of the example systems and components described herein can be different. For example, elements can be added, deleted, or rearranged compared to the disclosed embodiments.

[0296] Conditional language, such as "can", "could", "might", or "may", unless specifically stated otherwise or understood otherwise in the context in which it is used, generally is intended to convey that some embodiments include, while other embodiments do not include, certain features, elements, and / or steps. Thus, such conditional language is generally not intended to imply that one or more embodiments require, in any way, the features, elements, and / or steps, or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether to include or perform these features, elements, or steps in any particular embodiment. The term "including" means "including but not limited to". The term "or" means "and / or".

[0297] Any process descriptions, elements, or modules in the flowcharts or block diagrams described herein and / or shown in the figures should be understood as potentially representing modules, segments, or portions of code that include one or more executable instructions for implementing specific logical functions or steps in the process. Those skilled in the art will understand that alternative implementations are included within the scope of the embodiments described herein, where elements or functions may be deleted according to the functions involved, executed in the order shown or discussed, including substantially simultaneously or in the reverse order.

[0298] All of the above methods and processes can be implemented, at least in part, in software code modules executed by one or more computers and be partially or fully automated by the software code modules. For example, the methods described herein can be executed by a computing system and / or any other suitable computing device. These methods can be executed on a computing device in response to the execution of software instructions or other executable code read from a tangible computer-readable medium. A tangible computer-readable medium is a data storage device that can store data readable by a computer system. Examples of computer-readable media include read-only memory, random access memory, other volatile or non-volatile storage devices, CD-ROMs, magnetic tapes, flash drives, and optical data storage devices.

[0299] It should be emphasized that many variations and modifications can be made to the above embodiments, and the elements of such variations and modifications should be understood to be among other acceptable embodiments. All such modifications and variations are intended to be included within the scope of the present invention. The above description details certain embodiments. However, it should be understood that, no matter how detailed the above is described in the text, these systems and methods can be practiced in many ways. For example, the features of one embodiment can be used with the features of another embodiment. As mentioned above, it should be noted that the use of specific terms in describing certain features or aspects of the systems and methods should not be construed as implying that the term is redefined herein to be limited to any specific feature including the features or aspects of the systems and methods associated with the term.

[0300] This disclosure presents various embodiments of physiological monitoring devices, methods, and systems. These various embodiments can be used alone or in combination, and various changes can be made to the individual features of the embodiments without departing from the scope of the present invention. For example, in certain cases, the order of various method steps may be changed, and / or one or more optional features may be added to or removed from the described devices. Thus, the description of the above embodiments should not be construed as unduly limiting the scope of the present invention as claimed.

[0301] Various modifications can be made to the implementations described in the present invention, and the general principles defined herein can be applied to other implementations without departing from the spirit or scope of the present invention. Therefore, the scope of the present invention is not intended to be limited to the implementations shown herein, but rather should be accorded the broadest scope consistent with the present invention, the principles disclosed herein, and the novel features.

[0302] Certain features described in the context of a single embodiment in this specification can also be implemented in combination with a single embodiment. Conversely, the various features described in the context of a single embodiment can also be implemented separately in multiple embodiments or in any suitable sub-combination. Additionally, although the above features may be described as acting in certain combinations and were even initially claimed as such, in some cases, one or more features of the claimed combination can be removed from the combination, and the claimed combination can be directed to a sub-combination or a variant of the sub-combination.

[0303] Similarly, although operations are depicted in the figures in a particular order, these operations need not be performed in the particular order or sequence shown, nor do all the shown operations need to be performed to achieve the desired result. Additionally, the figures may schematically depict another example process in the form of a flowchart. However, other operations not depicted can be incorporated into the example process shown schematically. For example, one or more additional operations can be performed before, after, simultaneously with, or between any of the shown operations. Further, the separation of the various system components in the above embodiments should not be construed as requiring such separation in all embodiments. Additionally, other embodiments are within the scope of the following claims. In some cases, the operations recited in the claims can be performed in a different order and still achieve the desired result.

Claims

1. An electronic device configured to monitor a user's physiological signals, the electronic device comprising: a housing that at least partially encapsulates a circuit board configured to process physiological signals to infer the user's physiological characteristics; a flexible wing extending from the housing and configured to be fixed to the user's surface; and an optical sensor assembly located on the flexible wing and configured to acquire a photoplethysmogram signal, wherein the optical sensor assembly includes an optical emitter configured to emit light and an optical detector configured to receive light, wherein at least a portion of the light emitted by the optical emitter is directed into the user's skin and received by the optical detector from the user's skin, wherein the optical sensor assembly further includes a first directing layer between the optical emitter and the user's surface and a second directing layer between the optical detector and the user's surface, wherein the first directing layer directs the light from the optical emitter to the user's surface, and the second directing layer directs the light from the user's surface to the optical detector.

2. The electronic device according to claim 1, wherein the first directing layer includes a first convex lens and the second directing layer includes a second convex lens.

3. The electronic device according to claim 2, wherein the first convex lens and the second convex lens are positioned to extend under the flexible wing such that when the electronic device is fixed to the user's skin, the first convex lens and the second convex lens press into the user's skin.

4. The electronic device according to any one of claims 1 to 3, wherein the optical sensor assembly further includes an opaque barrier located between the first directing layer and the second directing layer.

5. The electronic device according to claim 4, wherein the opaque barrier blocks at least a portion of the light emitted by the optical emitter from being received by the optical detector without passing through the user's skin.

6. The electronic device according to claim 4 or claim 5, wherein the opaque barrier is configured to direct at least a portion of the light from the user's surface to the optical detector.

7. The electronic device according to any one of claims 4 to 6, further comprising a reflective layer located between the opaque barrier and the user's skin.

8. The electronic device according to claim 7, wherein the reflective layer reflects the light from the first directing layer.

9. The electronic device according to any one of claims 4 to 8, wherein the first directing layer and the second directing layer protrude beyond a portion of the opaque barrier, overlap at least the portion of the opaque barrier, and increase the contact area with the user's skin.

10. The electronic device according to any one of claims 1 to 9, wherein the first directing layer and the second directing layer are configured to direct or redirect the passage of light of a specific wavelength.

11. The electronic device according to claim 1, wherein the first directing layer includes a first concave lens and the second directing layer includes a second concave lens.

12. The electronic device according to claim 11, wherein the first concave lens and the second concave lens are formed of a high refractive index material that matches the refractive index of the stratum corneum of the user's chest.

13. The electronic device according to claim 1, wherein the first alignment layer includes a first hemispherical lens, and the second alignment layer includes a second hemispherical lens.

14. The electronic device according to claim 13, wherein both the first hemispherical lens and the second hemispherical lens include sapphire hemispherical lenses.

15. The electronic device according to claim 13 or claim 14, further comprising a first adhesive layer and a second adhesive layer, the first adhesive layer being configured to fix the first hemispherical lens to the optical emitter, and the second adhesive layer being configured to fix the second hemispherical lens to the optical detector.

16. The electronic device according to any one of claims 1 to 15, wherein the circuit board includes a flexible circuit board.

17. The electronic device according to any one of claims 1 to 16, further comprising a backing substrate that applies pressure on the circuit board to increase the contact between the optical emitter and the user's skin, increase the contact between the optical detector and the user's skin, or increase the contact between the optical emitter and the user's skin and between the optical detector and the user's skin.

18. The electronic device according to any one of claims 1 to 17, wherein the optical sensor assembly includes a plurality of optical emitters including the optical emitter, and when the flexible wing is fixed to the user's surface, the plurality of optical emitters clamp the user's skin, causing a portion of the skin to be located between the plurality of optical emitters, such that the plurality of optical emitters focus light onto the skin portion located between the plurality of optical emitters.

19. The electronic device according to any one of claims 1 to 18, wherein the optical sensor assembly includes a plurality of optical detectors including the optical detector, and when the flexible wing is fixed to the user's surface, the plurality of optical detectors clamp the user's skin, causing a portion of the skin to be located between the plurality of optical detectors, such that the plurality of optical detectors receive light from the skin portion located between the plurality of optical detectors.

20. The electronic device according to any one of claims 1 to 19, wherein when the flexible wing is fixed to the user's surface, the optical emitter and the optical detector clamp the user's skin, causing a portion of the skin to be located between the optical emitter and the optical detector, to guide light from the optical emitter through the user's skin to the optical detector.

21. The electronic device according to any one of claims 1 to 20, wherein the optical sensor assembly further includes an optical cable or an optical waveguide configured to guide light from the optical emitter to the user's skin.

22. The electronic device according to any one of claims 1 to 21 further includes a spring configured to apply pressure to increase the contact between the optical emitter and the user's skin and increase the contact between the optical detector and the user's skin.

23. An electronic device configured to monitor a user's physiological signals, the electronic device comprising: a housing that at least partially encapsulates a circuit board configured to process physiological signals to infer the user's physiological characteristics; flexible wings extending from the housing and configured to conform to a user surface corresponding to the user's chest; an optical sensor assembly located on the flexible wings and configured to acquire a photoplethysmogram signal; and an adhesive layer connected to the surface of the flexible wings and configured to adhere the electronic device to the user surface, wherein the adhesive layer includes an optically transparent adhesive layer.

24. The electronic device according to claim 23 further includes a brightening film configured to reflect or refract light generated by the optical sensor assembly to the user's skin.

25. The electronic device according to claim 24, wherein the brightening film is located between the adhesive layer and the optical sensor assembly.

26. The electronic device according to claim 24, wherein the brightening film is integrated with the adhesive layer.

27. The electronic device according to claim 24, wherein the brightening film is substantially flush with the optical elements of the optical sensor assembly.

28. The electronic device according to claim 24, wherein the brightening film rises towards the circuit board to provide space for the user's skin to bulge.

29. The electronic device according to any one of claims 23 to 28, wherein the optical sensor assembly includes a photodiode and a light-emitting diode.

30. The electronic device according to claim 29, wherein the optically transparent adhesive layer connects the photodiode and the light-emitting diode to the user's skin.

31. The electronic device according to claim 29, wherein the optically transparent adhesive layer surrounds the photodiode and the light-emitting diode without covering the photodiode and the light-emitting diode.

32. The electronic device according to claim 23 further includes a wicking material configured to absorb or evaporate sweat or body secretions.

33. The electronic device according to claim 32, wherein the wicking material includes a polyester-based material.

34. The electronic device according to claim 32 or claim 33, wherein the wicking material is interwoven with the adhesive layer.

35. The electronic device according to any one of claims 32 to 34, wherein the wicking material is located around the optical elements of the optical sensor assembly.

36. The electronic device according to any one of claims 23 to 35 further includes a channel located around the optical elements of the optical sensor assembly and configured to allow sweat or body secretions to evaporate or escape.

37. The electronic device according to claim 36, wherein the channel is within the adhesive layer.

38. The electronic device according to any one of claims 23 to 37, wherein the circuit board comprises a flexible printed circuit board.

39. The electronic device according to claim 38, wherein the flexible printed circuit board comprises a backing layer having channels that allow sweat or body secretions to evaporate or escape.

40. The electronic device according to any one of claims 23 to 39, wherein the adhesive layer and the optical elements of the optical sensor assembly are fixed to the backing layer.

41. The electronic device according to claim 40, further comprising a physical barrier between the adhesive layer and the optical elements to prevent the adhesive from leaking and contacting the optical elements.

42. The electronic device according to claim 41, wherein the physical barrier is inclined towards the adhesive layer.

43. The electronic device according to any one of claims 23 to 42, wherein the adhesive layer comprises a plurality of adhesives.

44. The electronic device according to claim 43, wherein the plurality of adhesives comprises a first adhesive and a second adhesive, wherein the first adhesive is closer to the optical elements of the optical sensor assembly than the second adhesive, and wherein the viscosity of the first adhesive is different from the viscosity of the second adhesive.

45. The electronic device according to claim 44, wherein the first adhesive is thinner than the second adhesive.

46. The electronic device according to any one of claims 23 to 45, further comprising an adhesive layer at least partially surrounding the optical sensor assembly.

47. The electronic device according to claim 46, wherein the adhesive layer at least partially surrounding the optical sensor assembly is not optically transparent.

48. The electronic device according to any one of claims 23 to 47, further comprising a hydrophobic or hydrophilic material at least partially surrounding the optical sensor assembly to direct sweat or body secretions away from the optical sensor assembly.

49. The electronic device according to any one of claims 23 to 48, further comprising perforations located around the optical elements of the optical sensor assembly and configured to allow sweat or body secretions to evaporate or escape.

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