Wearable device

Abstract

The invention discloses a wearable device. In some embodiments, the wearable device comprises: a sensing module; the wearable device includes a sensing module, and a strap attached to the sensing module, the wearable device configured to be worn by a user with a lower surface of the sensing module in contact with the user, the strap extending over an upper surface of the sensing module.

Description

Technical Field

[0001] One or more aspects of embodiments according to the present disclosure relate to health monitoring, and more particularly to wearable devices for health monitoring. Background Art

[0002] In various situations, it may be advantageous to periodically or continuously monitor various aspects of a subject or patient's health status without requiring the patient to visit a clinic where specialized diagnostic equipment is available.

[0003] Aspects of the present disclosure are relevant with respect to this general technical environment. Summary of the invention

[0004] According to an embodiment of the present disclosure, a wearable device is provided, which includes: a sensing module; and a strap attached to the sensing module, the wearable device being configured to be worn by a user, wherein a lower surface of the sensing module contacts the user and the strap extends over an upper surface of the sensing module.

[0005] In some embodiments, the wearable device is configured to be worn on the wrist of a user.

[0006] In some embodiments, a portion of the strap is constructed from an elastomer.

[0007] In some embodiments, the portion of the strap is pre-shaped to conform to the upper surface of the sensing module and the sides of the sensing module.

[0008] In some embodiments, a portion of the strap is a fabric strap.

[0009] In some embodiments, a portion of the strap is an elastic fabric strap.

[0010] In some embodiments, the strap is configured to slide longitudinally relative to the sensing module.

[0011] In some embodiments: the wearable device is configured to be worn on a wrist of a user; and the wearable device is configured to accommodate a wrist circumference of 6.8 inches.

[0012] In some embodiments: the wearable device is configured to be worn on a wrist of a user; and the wearable device is configured to accommodate a wrist circumference of 6.0 inches.

[0013] In some embodiments, the sensing module includes: a first strap slot located on a first side of the sensing module; and a second strap slot located on a second side of the sensing module, the second side being opposite to the first side.

[0014] In some embodiments, the lower surface of the sensing module includes a user contact surface.

[0015] In some embodiments, the sensing module includes: a shell having a first window in a lower surface of the shell; and a partially transparent disk in the first window, wherein: the partially transparent disk protrudes below the lower surface of the shell, and the user contact surface is the lower surface of the partially transparent disk.

[0016] In some embodiments, the wearable device also includes an electrical connector, wherein: the shell further has a second window located in the lower surface of the shell; and the electrical connector is located in the second window.

[0017] In some embodiments, the partially transparent disk is a glass-metal assembly comprising: a metal disk having a first window; and a first glass window covering the first window of the metal disk.

[0018] In some embodiments: the first glass window protrudes no more than 100 microns below the lower surface of the metal disk, and the first glass window is recessed no more than 200 microns into the metal disk.

[0019] In some embodiments, a portion of the first glass window has a speckle contrast parameter less than 0.7.

[0020] In some embodiments: the glass-metal assembly further comprises a second glass window; the metal disk further comprises a second window; and the second glass window covers the second window of the metal disk.

[0021] In some embodiments: the glass-metal assembly has a first wall that is part of a partition that separates a light emitting region of the sensing module from a light detection region of the sensing module; a first window of the metal disk opens to the light emitting region; and a second window of the metal disk opens to the light detection region.

[0022] In some embodiments, the sensing module also includes a sensor printed circuit board assembly located on the partially transparent disk, the sensor printed circuit board assembly including a spectrophotometer configured to illuminate the user's skin using light transmitted through a first transparent portion of the partially transparent disk, and to detect light that returns to a photodetector of the spectrophotometer through a second transparent portion of the partially transparent disk after being transmitted through the user's tissue.

[0023] In some embodiments, the sensing module further includes: a battery bracket located on the sensor printed circuit board assembly; and a battery located on the battery bracket, wherein the battery bracket is configured to protect the battery from damage by components of the sensing module below the battery. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] These and other features and advantages of the present disclosure will be appreciated and understood with reference to the specification, claims and drawings, in which:

[0025] Figure 1A is a perspective view of a wearable device according to an embodiment of the present disclosure;

[0026] Figure 1B is an exploded perspective view of a sensing module according to an embodiment of the present disclosure;

[0027] Figure 1C is a perspective view of a binding strap according to an embodiment of the present disclosure;

[0028] Figure 1D is an exploded perspective view of a portion of a sensing module according to an embodiment of the present disclosure;

[0029] Figure 1E is an exploded perspective view of a portion of a sensing module according to an embodiment of the present disclosure;

[0030] Figure 1F is a perspective view of a portion of a sensing module according to an embodiment of the present disclosure;

[0031] Figure 1G is an exploded perspective view of a portion of a sensing module according to an embodiment of the present disclosure;

[0032] Figure 1H is a plan view of a portion of a sensing module according to an embodiment of the present disclosure;

[0033] Fig. 1I is a perspective view of a portion of a sensing module according to an embodiment of the present disclosure;

[0034] Figure 1J is an exploded perspective view of a portion of a sensing module according to an embodiment of the present disclosure;

[0035] Figure 1K is an exploded perspective view of a portion of a sensing module according to an embodiment of the present disclosure;

[0036] Figure 1L is a perspective view of a portion of a sensing module according to an embodiment of the present disclosure;

[0037] Figure 1M is a perspective view of a portion of a sensing module according to an embodiment of the present disclosure;

[0038] Figure 1N is an exploded perspective view of a portion of a sensing module according to an embodiment of the present disclosure;

[0039] Fig.1O is an exploded perspective view of a sensing module according to an embodiment of the present disclosure;

[0040] Figure 1P is a photograph of parts of a sensing module according to an embodiment of the present disclosure;

[0041] Figure 1Q is a photograph of parts for a sensing module according to an embodiment of the present disclosure;

[0042] Figure 1R is a photograph of parts for a sensing module according to an embodiment of the present disclosure;

[0043] Figure 1S is a photograph of parts for a sensing module according to an embodiment of the present disclosure;

[0044] Figure 1T is a photograph of parts for a sensing module according to an embodiment of the present disclosure;

[0045] Figure 2A is a flow chart of a method according to an embodiment of the present disclosure;

[0046] Figure 2B is a flow chart of a method according to an embodiment of the present disclosure;

[0047] Figure 2C is a flow chart of a method according to an embodiment of the present disclosure;

[0048] Figure 2D is a flow chart of a method according to an embodiment of the present disclosure;

[0049] Figure 2E is a flow chart of a method according to an embodiment of the present disclosure;

[0050] Figure 3 A system according to an embodiment of the present disclosure is shown;

[0051] Figure 4 A modified system according to an embodiment of the present disclosure is shown;

[0052] Figure 5 A wearable device according to an embodiment of the present disclosure is shown;

[0053] Figure 6 A modified wearable device according to an embodiment of the present disclosure is shown;

[0054] Fig. 7A shows a front view of an optical sensing module according to an embodiment of the present disclosure;

[0055] Figure 7B shows a rear view of an optical sensing module according to an embodiment of the present disclosure;

[0056] Figure 7C shows a cross-sectional view of an optical sensing module according to an embodiment of the present disclosure;

[0057] Figure 8 shows a reflector with an incorporated FIG. 7A to FIG. 7C Optical sensing module;

[0058] Fig. 9 Shows the operation Figure 8 Optical sensing module;

[0059] Fig.10 Schematically shows FIG. 7A to FIG. 8 a variation of an optical sensing module comprising a single transmitter / receiver PIC with an integrated photodetector; and

[0060] Fig.11 is an example of an emitter PIC with a single output aperture, which may form part of an optical sensing module. DETAILED DESCRIPTION

[0061] The detailed description given below in conjunction with the accompanying drawings is intended to describe exemplary embodiments of wearable devices provided according to the present disclosure, and is not intended to represent the only form in which the present disclosure can be constructed or utilized. The description sets forth the features of the present disclosure in conjunction with the illustrated embodiments. However, it should be understood that the same or equivalent functions and structures can be implemented by different embodiments, which are also intended to be included in the scope of the present disclosure. As shown elsewhere herein, similar element numbers are intended to indicate similar elements or features.

[0062] refer to Figure 1A In some embodiments, the wearable device includes a sensing module 105 and a strap 110. The sensing module 105 may include a light emitting diode (LED) indicator 107 and a button 108, as well as other features (discussed in further detail below). The wearable device can be configured to be worn by a user (e.g., on the user's wrist, or elsewhere on the user, such as on the user's leg or chest, with a suitably sized strap, as discussed in further detail below). The lower surface of the sensing module 105 may include a partially transparent disk (e.g., a glass-metal assembly 132 as shown), the lower surface of which may be a user contact surface that contacts the user's skin when the wearable device is worn by the user. As used herein, a "partially transparent disk" is a disk having a transparent portion and an opaque portion. In Figure 1AIn an embodiment, the partially transparent disk includes seven transparent portions, each of which can be a glass window covering a corresponding opening (or "window") in a metal disk having seven windows. As used herein, a "window" is (i) an opening; or (ii) a transparent or translucent element covering such an opening; or (iii) a transparent portion on an otherwise opaque sheet. The sensing module 105 can include one or more sensors configured to optically interact with the user's tissue through the windows, as discussed in further detail below. The lower surface of the sensing module 105 can also include an electrical connector or "charging port" 133, which can be used to charge the sensing module 105 or communicate with the sensing module 105.

[0063] refer to Figure 1B , the sensing module 105 may include a housing including an upper housing or "cover" 111 (which may be composed of a polymer, such as injection molded plastic), a lower housing or "bottom cover" 128 (which may be composed of a metal, such as stainless steel), and a partially transparent disk 132. The strap 110 may be attached to the sensing module, for example, the strap 110 may extend through a first strap slot 115 on a first side of the upper housing 111, over the upper surface of the sensing module (in a channel 120 in the top of the upper housing 111), and through a second strap slot on a second side of the upper housing 111 (opposite the first side). Within the housing, the sensing module 105 may also include an insulating sheet 126 (e.g., a Kapton sheet) on the inner lower surface of the lower housing 128, a sensor printed circuit board assembly (PCBA) 124 on the insulating sheet (fixed in place by screws 123), a host printed circuit board assembly 122 on the sensor printed circuit board assembly 124 (fixed in place by screws 123), a battery bracket 118 on the host printed circuit board assembly 122, a battery 116 (e.g., a lithium polymer (LiPo) battery) on the battery bracket 118, and an antenna 114 on the battery 116 (connected to the host printed circuit board assembly via a coaxial cable 117). The battery bracket 118 may be or include a rigid (e.g., metal) sheet to protect the battery 116 from damage by components on the host printed circuit board assembly 122 (e.g., to protect the battery 116 from being pierced by, for example, components with sharp corners). In some embodiments, the lower housing 128 is made of a dielectric material (e.g., injection molded plastic) and may be devoid of the insulating sheet 126. The upper housing 111 may be secured to the lower housing 128 by a pressure sensitive adhesive 112 (or, if the lower housing 128 is comprised of injection molded plastic, by ultrasonic welding).

[0064] refer to Figure 1C, the strap 110 may be made of an elastic body, a portion of which (e.g., the upper portion 109) may be pre-formed to conform to the upper surface of the sensing module (e.g., the upper surface of the upper housing 111). As used herein, the strap 110 being "pre-formed" to conform to the upper surface means that the strap 110 is manufactured so that when no external force is applied to the strap 110 to deform it, it assumes a shape (such as Figure 1C ), a portion 109 of the shape is the shape that the strap 110 has when it passes through the first strap slot 115, through the channel 120, and through the second strap slot. The strap 110 can have two ends and a clasp (e.g., an adjustable clasp) for securing the two ends together. In some embodiments, the strap 110 is a fabric strap that can slide longitudinally within the strap slot 115 and the channel 120 to provide a wider range of adjustability so that a wider range of wrist sizes can be accommodated. In some embodiments, the strap 110 has a loop 113 at one end, and the second end is configured to pass through the loop and fold back on itself, such as Figure 1A and Figure 1C As shown. End cap 106 can prevent the end of the strap from slipping out of loop 113, making it easier for the user to put the strap on the user's wrist with one hand using the other hand. In some embodiments, strap 110 can accommodate (e.g., fit tightly) a minimum wrist circumference between 4.5 inches and 7.0 inches. In some embodiments, strap 110 can accommodate (e.g., fit) a maximum wrist circumference between 6.0 inches and 8.5 inches. In some embodiments, strap 110 is an elastic fabric strap.

[0065] refer to Figure 1D , the lower housing 128 may include: (i) a first window 129 into which a partially transparent disk 132 may fit and may be secured to the first window and sealed with a pressure sensitive adhesive (PSA) 112; and (ii) a second window 131 into which an electrical connector 133 may fit and may be secured and sealed to the second window with a pressure sensitive adhesive 112. In some embodiments, the lower housing 128 is constructed of plastic (and may be formed by injection molding); in such embodiments, the second window 131 may be absent, and the conductors of the electrical connector 133 may be insert molded directly into the lower housing 128.

[0066] The button 108 may be sealed to the lower housing 128 with two O-rings 137. Two springs 139 may return the button 108 to its original position after being pressed, and may be prevented from extending too far from the lower housing 128 by an E-clip 141. The LED indicator 107 may include a light guide 134 that guides light from the LED 136 ( Figure 1K) through the wall of the lower housing 128. The partially transparent disk 132 (e.g., a glass-metal assembly) can have a plurality of screw bosses 127, each screw boss for receiving a corresponding screw 123. The partially transparent disk 132 can further have one or more walls 125, each wall being part of a partition separating a light emitting area of ​​the sensing module from a light detection area of ​​the sensing module. Each of these areas can be a volume in the sensing module 105 that is optically sealed except for a window. For example (as discussed in further detail below), a light-blocking epoxy can be dispensed onto the top surface of each wall 125, and an opaque cover (e.g., a printed circuit board assembly) can be placed on top of the wall 125 to seal each area. Sealing the light emitting area from the light detection area can reduce noise and sensing errors that may otherwise be associated with light leaking from the light emitting area to the light detection area. The glass-metal assembly 132 can be formed by bonding a glass window to each of the plurality of windows (openings) of the metal disk. The metal disk can be manufactured by computer numerical control (CNC) machining or metal injection molding. The glass windows can be bonded to the metal disk using epoxy or using an airtight metal-glass seal. The lower surface of each glass window can be flush with the lower surface of the metal disk, or slightly recessed within the lower surface of the metal disk, so that (i) the lower surface of the glass window can contact the user's skin (and there is no air gap between the glass and the skin), and (ii) the lower surface of the metal disk can contact the user's skin (avoiding the presence of an air gap between the metal disk and the user's skin, through which light may leak). For example, in some embodiments, the first glass window protrudes no more than 100 microns below the lower surface of the metal disk, and the first glass window is recessed no more than 200 microns within the metal disk. Figure 1E yes Figure 1D An enlarged view of a portion of.

[0067] The sensing module may include a laser light source and a plurality of light emitting diode (LED) light sources. Figure 1F Shows Figure 1A , Figure 1B and Figure 1DThe user contact surface 135 of the glass-metal assembly 132 of the housing. In some embodiments, the partially transparent disc 132 protrudes below the outer lower surface of the housing (e.g., between 1.0 mm and 4.0 mm) to provide improved contact between the user contact surface 135 and the user's skin. The laser light source that can illuminate the user's skin through the first glass window 142 can include an array of short-wave infrared (SWIR) lasers, each laser operating at a different wavelength; these lasers can be turned on one at a time. The first detector behind the second glass window 144 can receive the laser after the laser has been transmitted through the user's tissue (e.g., through the skin, or through the skin and through the tissue under the skin). The wavelength dependence of the portion of the transmitted light detected by the detector can be used to infer aspects of the chemical composition of the tissue. A device that measures the transmittance of two or more wavelengths (e.g., transmitted through the user's tissue) may be referred to herein as a "spectrophotometer." The red LED and infrared LED (which can be co-packaged) can illuminate the user's skin through the third glass window 146, and the green LED can illuminate the user's skin through the fourth glass window 148. The three detectors behind the corresponding glass windows (fifth glass window 150, sixth glass window 152, and seventh glass window 154) can each receive light from one or more of the LEDs after the light has been transmitted through the user's tissue. In some embodiments, for example, in an embodiment in which the sensing module 105 includes two independent sensing systems that do not operate simultaneously (e.g., one using a laser source and one using an LED), the light emitting area of ​​one sensing system can share an area or compartment with the light detection area of ​​another sensing system. The inner surface of either or both of the first glass window 142 and the second glass window 144 can be roughened (e.g., by laser etching or sandblasting) to have a transmittance of at least 60% (e.g., at least 85%), a scattering fraction of at least 70% (e.g., at least 95%), and a speckle contrast parameter of less than 0.7 (e.g., a speckle contrast parameter of less than 0.55). Such a surface can have a surface roughness with an average profile height deviation from the mean line (Ra) of 25 microns. Roughening of the transmit window can improve illumination uniformity and device-to-device variability, and roughening of the receive window can reduce Fresnel reflections and bring the speckle generating surface closer to the detector, thereby mitigating speckle noise.

[0068] In some embodiments, aluminum oxynitride windows can be used instead of glass windows. Such aluminum oxynitride windows can be made by loading aluminum oxynitride powder into a cavity in a metal disk and placing the metal disk in a hot isostatic press (HIP) together with a suitable mold, wherein the surface of the mold defines the surface of the aluminum oxynitride that is not in direct contact with the metal disk. Because the aluminum oxynitride windows are made from a mold, the aluminum oxynitride windows can be made into lenses, or they can be molded into a shape that is close to the desired final shape, making it easier to obtain the final desired shape. Figure 1P Here are photos of the various parts used in practice. Figure 1Q to Figure 1T is a photograph of a prototype of glass-metal assembly 132 .

[0069] Figure 2A A method is shown (corresponding to Figure 1D and Figure 1E ), which can be used to assemble the lower housing 128 with certain other components. The method includes: ultrasonic cleaning at 201; installing the light pipe assembly at 203; installing the button assembly at 205; installing the charging port using the charging port PSA 112 at 207; and installing the sensor disk (glass-metal assembly 132) using the corresponding PSA 112 at 209. Figure 2B A flow chart showing a method for mounting the sensor printed circuit board assembly 124 in the lower housing 128 (corresponding to Figure 1G , Figure 1H and Fig. 1I ). The method includes: placing the bottom cover 128 in a fixture or tray at 212; placing an insulating sheet 126 (e.g., Kapton tape) at 214; dispensing a light-blocking epoxy at 216; applying thread lock to the screw bosses 127 (at three locations) at 218; placing the sensor PCBA 124 at 220; torqueing three screws at 222; flipping the part in the fixture or tray at 224; applying thermal curing at 226; and performing optical testing and hardware (HW) built-in self-test (BIST) at 228. Figure 2B In an embodiment, the sensor PCB assembly 124 optically sealed to the top of the wall 125 of the glass-metal assembly 132 serves as an opaque cover for the glass-metal assembly 132. To increase the opacity of the sensor PCB assembly, the ground planes of the sensor PCB assembly can be filled as much as possible (e.g., each ground plane can be filled at least 30%), and a black solder mask can be used. Figure 2C A flowchart (corresponding to FIG. 1 ) showing a method for assembling a host printed circuit board assembly 122, a battery 116, and an antenna 114 Figure 1J). The method includes: pre-bending the flexible cable assembly 130 at 230; assembling the flexible cable assembly 130 to the host PCBA 122 at 232; assembling the coaxial antenna 114 to the host PCBA 122 at 234; assembling the battery connector to the host PCBA 122 at 236; and routing cables (e.g., coaxial cables of the coaxial antenna 114 and wiring for the battery) to the side of the host PCBA 122 at 238.

[0070] Figure 2D is a flow chart of the method in some embodiments (corresponding to Figure 1K , Figure 1L and Figure 1M ). The method includes assembling the flex cable 130 to the sensor PCBA 124 at 240; applying thread lock to the screw bosses 127 in 4 locations at 242; assembling the host PCBA 122 at 244; torqueing the two screws 123 at 246; assembling the battery PSA 112 to the battery bracket 118 at 248; assembling the battery bracket 118 to the host PCBA 122 at 250; torqueing the two screws 123 at 252, aligning the battery 116 to the battery bracket 118 and PSA 112 at 254; exposing the antenna PSA 112 and centering it on top of the battery 116 at 256; and performing a self-diagnostic test at 258.

[0071] Figure 2E is a flow chart of the method in some embodiments (corresponding to Figure 1N and Fig.1O ). The method includes placing the cover PSA 112 on a fixture (which may be referred to as fixture #1) at 260; removing the PSA liner (which may be referred to as liner #1) at 262; placing the cover 111 on a fixture (which may be referred to as fixture #2) at 264; assembling fixture #1 to fixture #2 at 266; clamping and applying vacuum and clamping pressure for a certain time at 268; removing fixture #1 at 270; removing the PSA liner (which may be referred to as liner #2) at 272; checking alignment at 274; aligning the cover to the bottom cover fixture at 276; clamping and applying vacuum and clamping pressure for a certain time at 278; and performing a final functional test at 280.

[0072] Capturing biometric data from a patient can be beneficial in a variety of clinical or home healthcare settings, for example, to sense levels of compounds in tissue (e.g., glucose), to measure other characteristics of tissue (e.g., temperature), or to distinguish between different types of tissue (e.g., to distinguish healthy tissue from diseased tissue).

[0073] Therefore, in a first aspect, some embodiments provide a system comprising: a first module comprising a first sensor capable of performing biometric sensing at a first location on a patient; and a second module comprising a second sensor capable of performing biometric sensing at a second location on the patient, wherein the first module comprises a transmitter for sending first sensor data, the first sensor data comprising sensing information obtained by the first sensor.

[0074] By enabling the first module and the second module to perform biometric sensing at different locations on the patient, a number of advantages can be provided. For example, redundant measurements can be made. Further, differential measurements of the same biomarker can be made to enhance the fidelity of the signal (e.g., reduce the signal-to-noise ratio), especially when calibrated with a known source. It can also provide insight into anatomical differences.

[0075] The system may have any one of the following optional features, or any combination of the following optional features to the extent they are compatible.

[0076] The first module and / or the second module can form a discrete subcomponent of a larger device or monitoring system. That is, the system can be a single device (comprising the first module and the second module), or can be a monitoring system in which the modules are provided in different devices. For example, the first module and the second module can be discrete integrated circuits (electronic, photonic or a mixture thereof) located in a patient monitoring system or device. In some examples, the first module and the second module are arranged in a separate device that can be independently positioned on the patient. For example, the first module can be located in an element worn or attached to the patient at a first position (for example, in a wristband worn by the patient), and the second module can be located in another element worn or attached to the patient at a second position different from the first position (for example, a piece of clothing, a chest strap, an earring, an ankle strap, an adhesive patch, an arm or bicep strap, or a ring).

[0077] The system may include additional modules including sensors capable of performing biometric sensing at additional locations on the patient. The system may form a distributed sensor network. Data from the sensors may be provided to a processing unit, which may be in one of the first or second modules, or may be a separate module. The processing unit may be or may be in a third or other module, such as a mobile device (e.g., a mobile phone, tablet computer, laptop computer, or other computer) that communicates unidirectionally or bidirectionally with the module containing the sensor. The processing unit may be, for example, a remote unit in a cloud computing system connected to the module via a network connection.

[0078] One of the modules can be considered the master unit or master module and can control the other modules of the system. For example, it can prompt them to turn on or off, take readings or perform calibration procedures.

[0079] The modules may each include multiple sensors, or each sensor may be configured to undertake more than one type of biometric sensing. In either case, a large amount of biometric information is available, enabling multi-dimensional analysis of multiple factors.

[0080] One or more modules may be or include an optical sensing module or an optical sensor. The or each optical sensing module or optical sensor may include a transmitter photonic integrated circuit comprising a plurality of lasers, wherein each of the plurality of lasers operates at a wavelength different from the other lasers. The optical sensing module may include an optical manipulation region, which may include one or more of an optical modulator, an optical multiplexer, and an additional optical manipulation element. The module may include one or more light outputs of light from the laser. The optical sensing module may be, for example, as disclosed in WO 2021 / 116766 A1, the disclosure of which is incorporated herein by reference in its entirety.

[0081] In some examples, one or more of the sensors may be a photoplethysmograph (PPG), spot plethysmograph (SPG), or spectrophotometer operating in one or more wavelength bands such as visible light, near infrared, or shortwave infrared.

[0082] In one example, optical sensors are disposed on the top and bottom of the wristband (i.e., on the dorsal and ulnar / radial portions of the wristband), with the electronics disposed on the band. Positioning the sensor on the ulnar / radial portion of the patient's hand can enhance the data obtained by the sensor, for example, because of increased vascularization at that location compared to, for example, the dorsal region of the patient's hand.

[0083] The system may also include a third module including a receiver configured to receive the first sensor data and combine the first sensor data with other sensor data. The third module may be the second module. The other sensor data may include sensed information obtained by the second sensor. The first module may include a receiver for receiving a signal from the second module.

[0084] The third module may be a mobile phone. The first module may include a receiver for receiving a signal from the third module. The other sensor data may include sensed information obtained by the second sensor.

[0085] The transmitter may be a wireless transmitter. The transmitter may be a Bluetooth remote therapy monitoring (RTM) transmitter or a WiFi (RTM) transmitter.

[0086] The first sensor or the second sensor is capable of performing a type of biometric sensing selected from the group consisting of: blood sugar measurement, blood glucose measurement, core body temperature measurement, hydration level measurement, blood pressure measurement, respiratory rate measurement, SpO2 measurement, heart rate measurement, heart rate variability measurement, and combinations thereof.

[0087] The first module may not include a receiver. In other words, the first module may be arranged to communicate with the second module or the third module in a unidirectional manner by sending information to the second module or the third module but not receiving information from them. In some examples, the second module does not include a receiver.

[0088] The first sensor and the second sensor may be configured to perform redundant measurements. That is, the first sensor and the second sensor may be configured to perform the same type of biometric sensing.

[0089] The first module and the second module may be located within the wearable device. In this sense, the system may be considered a wearable device. The wearable device may be or include a wristband, and the first module and the second module may be located at different circumferential positions around the wristband (i.e., at different points around the wristband, the wristband having a generally circular or oval shape or surface). The wristband may include a clasp or other fixing mechanism that may be coupled or detached to form a complete or separate band, respectively. The clasp or other fixing mechanism may be used to form an electrical connection between components within or on the wristband.

[0090] The system may also include an indicator module configured to provide feedback to the user about the position of the wearable medical device on the user. The indicator module may be, for example, a plurality of LEDs that emit light to indicate that the wearable medical device is positioned at a predetermined position on the user. The system may also include an adjustment mechanism to change the size of the medical device. The wearable medical device may be a wristband that includes or is connectable to a watch module configured to display time, the wristband being arranged so that the watch module is or will be set on the back portion of the wristband, and the first module and the second module are set on the radial or ulnar portion of the wristband. The back portion generally refers to the upper portion of the wrist on the same side as the fingernails of the hand. The radial or ulnar portion is circumferentially located around the wrist, at a lower position, for example, on the same side as the palm. The wearable device may include a flexible battery cell.

[0091] The system may also include a notification module configured to provide feedback to the user of the value of the biomarker obtained from the sensor data. For example, the notification module may provide tactile or visual feedback (e.g., via a vibrator or LED) that the value of the biomarker is outside a predetermined range or exceeds a predetermined threshold.

[0092] The watch module may include one or more transmitters for connecting and communicating with another device, such as a mobile phone.

[0093] The wristband may be formed of a flexible material such as rubber, or of multiple links of relatively inflexible material (but with the aid of movable links as a means to conform to the shape of the patient). The wristband may be, for example, about 3 mm thick and about 20 mm wide.

[0094] The first sensor and the second sensor can be configured to perform the same type of biometric sensing at different locations on the patient. One or both of the first module and the second module can be configured to obtain a biomarker value from sensor data from both the first sensor and the second sensor. In some examples, a differential measurement is performed, which may include determining the difference between a biomarker value obtained from the sensor data of the first sensor and a biomarker value obtained from the sensor data of the second sensor. For example, the system can use a first sensor to determine a first blood pressure measurement at a point close to the patient's heart, and use a second sensor to determine a second blood pressure measurement from a point away from the patient's heart. The system is therefore able to determine that the patient may have poor blood circulation or insufficient perfusion based on the difference between the first blood pressure measurement and the second blood pressure measurement.

[0095] One or both of the first module and the second module can be configured to receive sensor data from both the first sensor and the second sensor, and derive the biomarker value from the sensor data from only one of the first sensor and the second sensor. The correlation module can examine the sensor data from the first sensor and the second sensor, and select the biomarker value from the sensor data with the highest quality.

[0096] Figure 3 A system 100 is shown. The system includes a first module including a first sensor capable of performing biometric sensing at a first location on a patient. Figure 3 In the illustrated system, the first module is one of the following: a necklace; a chest strap; an earring; a device worn in the inner ear; a wristband / watch; a ring; an ankle strap; an adhesive patch located on the body; an arm or bicep strap; or a mobile device. The second module is another chest strap; an earring; a wristband / watch; a ring; an ankle strap; an adhesive patch located on the body; an arm or bicep strap; or a mobile device. For example, the first module can be a wrist strap and the second module can be a chest strap. The first module includes a transmitter for sending first sensor data, wherein the first sensor data includes sensed information obtained by the first sensor.

[0097] As described above, the sensors in the first module and the second module are configured to (and therefore are capable of) performing biometric sensing at their respective locations on the patient. The sensors may be configured to sense: blood sugar level; blood glucose level; core body temperature; hydration level; blood pressure; respiratory rate; SpO2 level; heart rate; heart rate variability and combinations thereof. The sensors may achieve this by including photonic components, such as in a small photonic integrated circuit (PIC) that is combined with an application specific integrated circuit and / or a flexible electronic substrate. For example, by combining SPG and PPG data, the PIC may include two or three lasers with different wavelengths in the infrared and near infrared ranges.

[0098] Where the mobile device forms part of a system, it may communicate unidirectionally or bidirectionally with other modules including other sensors. For example, the modules including other sensors may be configured to only send signals to the mobile device and may not be able to receive signals from the mobile device.

[0099] The mobile device can process the received sensor data to derive biometric markers (e.g., heart rate, glucose levels, etc.). Additionally or alternatively, the sensor data can be sent to a cloud computing system for cloud integration, facilitating historical data storage and more powerful analysis techniques than can be performed on a mobile device. The data can also be shared with medical professionals directly or through the use of an electronic medical record (EMR) system. This can be achieved via the cloud (as shown) or directly from the mobile device.

[0100] Figure 4 A schematic diagram of a system 200 including three modules is shown. A first module 202 includes a sensor A configured to perform biometric sensing. A second module 204 includes a sensor B also configured to perform biometric sensing. A third module 206, referred to as a master unit, communicates with the first module 202 and the second module 204 (and they also communicate with each other). The third module may contain a sensor configured to perform biometric sensing, or may not, and may serve only as a processing or communication unit. In this example, the third module 206 is connected to a cloud computing system 208 of the type previously discussed, which may perform further analysis techniques or store data obtained from the sensors.

[0101] In some examples, the sensors in each module are configured to sense different kinds of biometric data (e.g., from the list discussed above), or they can be configured to sense the same kind of biometric data, or a subset of sensors can be configured to sense the same kind of biometric data while other sensors or subsets of sensors are configured to sense different kinds of biometric data. Each module can include more than one sensor, and thus different sensors within a module can each sense different kinds of biometric data.

[0102] In examples where the sensors of the various modules are configured to sense the same biometric data, the master unit can decide which data to use between the data from the different sensors based on a quality score or other ranking. The master unit can also be configured to utilize data from both (or all) sensors when deriving a given biometric marker. This can be accomplished, for example, by using differential analysis to provide greater accuracy for a given biomarker, or to study how a biomarker varies with anatomical location.

[0103] Additionally or alternatively, the sensors may perform redundant measurements (ie, both sensors record the same kind of data in the event that one or the other fails during a given data collection run).

[0104] Figure 5 A wearable device 300 is shown. In this example, the wearable device 300 is a wristband adapted to be worn on the patient's wrist. The wristband includes a plurality of sensors, such as a breathing rate sensor 1 (BR1), a breathing rate sensor 2 (BR2), a core body temperature 1 sensor (CB1), a core body temperature 2 sensor (CB2), an oxygen saturation sensor (SpO2), and a heart rate / heart rate variability sensor (HR / HRV).

[0105] In this example, the wearable device includes a watch module configured to display time. The watch module is located on the back of the wearable device, which corresponds to the back area of ​​the wristband when the wristband is worn on the patient, and therefore corresponds to the back portion of the patient. At least some of the sensors (which may be included in their own modules) are located on the radial or ulnar portion of the wristband to enhance data collection. The watch module in this example includes a transmitter (e.g., a Bluetooth (RTM) transmitter) for sending data from the sensors.

[0106] Figure 6A variant wearable device 400 is shown. The wearable device 400 is also a wristband that is about 20 mm wide (i.e., measured in a direction aligned with the patient's arm when worn) and about 3 mm thick (measured in the radial direction of the wristband). The wristband 400 includes a clip and an adjustment mechanism so that the loop formed by the wristband can be opened or closed by using a clip or clasp, and the radius or circumference of the wristband can be changed by using the adjustment mechanism. In some examples, the clip or clasp includes an electrical connector that connects the components of the wristband when closed.

[0107] The wristband 400 in this example is formed of a flexible material such as rubber so as to conform to the shape of the patient's wrist. In other examples not shown, the wristband is formed of a plurality of relatively inflexible links or elements that are connected together so as to be pivotable individually. In this way, although the wristband is not formed of a flexible material, the wristband can still conform to the shape of the patient's wrist.

[0108] The wristband 400 in this example includes an indicator unit for notifying the user whether they have placed the wristband in the correct predetermined position on their body. For example, the wristband 400 in this example includes a module including a PPG sensor, a SWIR sensor, and an SPG sensor. The indicator unit informs the user whether these sensors have been positioned above the patient's radial artery, for example by lighting one or more red LEDs (light emitting diodes) when the unit is not positioned correctly, and lighting one or more green LEDs when the unit is positioned correctly. The wristband 400 includes a flexible battery unit and a main PCB that can provide a third module. The sensor module in this example includes a SWIR sensor, an SPG sensor, and a PPG sensor.

[0109] In some embodiments, the sensing module 105 includes a reference FIG. 7A to FIG. 8 A portion of the optical sensing subassembly 1000 discussed. The optical sensing subassembly 1000 includes a transmitter photonic integrated circuit (PIC) 4 located on a substrate 2. The PIC 4 includes multiple lasers, each of the multiple lasers operating at a wavelength different from the other lasers. The multiple lasers form part of a light source 20, which generates light in the range of 1200nm to 2400nm. The multiple lasers can also be configured for variable duty cycle operation. The interrogation laser can vary in amplitude, phase, polarization or other optical properties, or a combination of these optical properties. Pulsing of light can reduce power consumption of the device and extend battery life.

[0110] The PIC 4 also includes an optical manipulation region for manipulating light in any desired manner prior to transmission to a surface (e.g., tissue) to be analyzed via one or more light outputs 12. Optical elements such as mirrors 15 (e.g., prisms) may be present. The optical manipulation region includes one or more of: an optical modulator, an optical multiplexer (MUX); and additional optical manipulation elements such as power insets, lenses, and power splitters.

[0111] In this example, the light source 20 also includes a plurality of non-laser light sources, such as LEDs 5 (eg, visible LEDs 5a or near infrared wavelength LEDs 5b).

[0112] One or more photodetectors 1, 1' also form part of the optical sensing subassembly 1000. Here, the photodetectors are located on the substrate 2, but are not part of the PIC 4. However, it is envisaged that the photodetectors may be an integral part of the transmitter / receiver PIC 4. In this example, the plurality of photodetectors include a silicon photodiode 1' and an InGaAs photodiode 1.

[0113] The microcontroller 11 is located on the back side of the substrate 2 of the optical sensing subassembly 1000, that is, opposite to the PIC 4. The electrical connector 13 provides electrical signals to the optical sensing subassembly, and includes a protective housing 7 (such as a cover and a base) of Figure 7C ) is used to cover the PIC 4 and other components to minimize the risk of damage during use. Figure 8 In the example of FIG. 1 , the optical sensing subassembly 1000 includes a large area detector array including smaller photodetector pixels 1106, such as Fig. 9 shown.

[0114] refer to Fig. 9 The operation of the optical sensing subassembly 1000 is described. Once manipulated (e.g., multiplexed), light from multiple lasers exits the PIC 4 via one or more optical output ports 12, and thus exits the optical sensing subassembly 1000. Light can be emitted into free space from a waveguide surface ("emission facet") at or near an edge of the PIC 4. An optical element such as a mirror 15 takes the planar light from the waveguide platform and converts it into a direction more suitable for interrogating the sampled tissue (e.g., the user's skin). This direction (see transmitted / reflected beam) can be orthogonal or substantially orthogonal to the plane of the PIC 4.

[0115] Backscattered light (see reflected beam) from the surface of the skin and the volume below the surface of the skin returns to the emitting facet (or, in some embodiments, a different waveguide facet) on the PIC 4 for analysis. Specifically, the reflected light returns to the PIC 4 to illuminate the respective active areas of the photodiodes 1, 1' and / or the photodetector pixels 1106.

[0116] Fig.10 Figures 7 to 7 are schematic diagrams showing Figure 8 1 is a block diagram of a variation of an optical sensing subassembly comprising a single transmitter / receiver PIC 4 with an integrated photodetector 1, such as a photodiode 1. With respect to the transmitter function, a plurality of lasers 24 provide light of different wavelengths to an optical manipulation region 25 before being output at one or more light outputs 26. With respect to the receiver function, light is received at one or more input apertures 27, which are optically coupled to the photodiode 1.

[0117] Fig.11is an example of an emitter PIC 1901 with a single waveguide output aperture 1902, which may form part of an optical sensing subassembly 1000 for non-invasive biomarker measurement. Here, the multiple lasers take the form of multiple hybrid DBR lasers 1903, including M III-V hybrid integrated RSOA gain chips or coupons 1908 (mounted by flip chip or micro transfer printing (MTP)) covering M wavelength bands, each wavelength band having 1..N wavelengths. Each of the M RSOAs is optically coupled to N DBR waveguides, each DBR waveguide 1909 selecting a sub-band within the wavelength band of the RSOA, thereby producing N wavelengths within each of the M wavelength bands. Therefore, the total number of output wavelengths from the multiple lasers is NxM. For each laser, a high reflective mirror is located at one end of the laser cavity within the RSOA. III-V RSOA gain chips or samples can be hybrid integrated so that the optical mode edge in the RSOA waveguide is coupled to the Si or SiN PIC waveguide so that the light in the RSOA and the light in the Si or SiN PIC waveguide stay in the same plane (see AJ Zilkie et al., "Power-efficient III-V / Silicon external cavity DBR lasers", Optics Express, Vol. 20, No. 21, p. 23456 (2012); AJ Zilkie et al., "Multi-Micron Silicon Platform for Highly Manufacturable and Versatile Photonic Integrated Circuits", IEEE Selected Topics in Quantum Electronics, Vol. 25, No. 5, (2019); both papers are incorporated herein by reference). In one example, only one laser is turned on in each time window, and in that time window, the photodiode 1 detects the reflected signal from that wavelength. The laser then circulates through. Fig.11 The PIC shown has an SOI platform. The same architecture can also be applied to a SiN platform, with the choice of waveguide platform depending on the operating wavelength of the laser. It is envisioned that a single platform could include both SOI and SiN components.

[0118] As used herein, "a portion" of something means "at least some" of that thing, and may also mean less than all of that thing or all of that thing. Likewise, "a portion" of a thing includes the entire thing as a special case, i.e., an example of a portion of the thing. As used herein, the term "or" is inclusive, so that, for example, "A or B" means any of (i) A, (ii) B, and (iii) A and B.

[0119] As used herein, the term "major component" refers to a component that is present in a composition, polymer, or product in an amount greater than the amount of any other single component in the composition or product. In contrast, the term "major component" refers to a component that accounts for at least 50% by weight or more of a composition, polymer, or product. As used herein, any structure or layer described as "made of" or "consisting of" a substance should be understood to (i) include the substance as a major component in some embodiments, or (ii) include the substance as a major component in some embodiments.

[0120] It should be understood that when an element or layer is referred to as being “on,” “connected to,” “coupled to,” or “adjacent to” another element or layer, it can be directly on, connected to, coupled to, or adjacent to another element or layer, or one or more intervening elements or layers may be present. In contrast, when an element or layer is referred to as being “directly on,” “directly connected to,” “directly coupled to,” or “adjacent to” another element or layer, there are no intervening elements or layers.

[0121] Any numerical range described herein is intended to include all sub-ranges of the same numerical precision contained in the range. For example, the range of "1.0 to 10.0" or "between 1.0 and 10.0" is intended to include all sub-ranges between the minimum value 1.0 and the maximum value 10.0, that is, the minimum value is equal to or greater than 1.0, and the maximum value is equal to or less than 10.0, such as 2.4 to 7.6. Similarly, the range described as "within 35% of 10" is intended to include all sub-ranges between the minimum value 6.5 (i.e. (1-35 / 100) multiplied by 10) and the maximum value 13.5 (i.e. (1+35 / 100) multiplied by 10), that is, the minimum value is equal to or greater than 6.5 and the maximum value is equal to or less than 13.5, such as 7.4 to 10.6. Any maximum numerical limit described herein is intended to include all lower numerical limits contained therein, and any minimum numerical limit described in this specification is intended to include all higher numerical limits contained therein.

[0122] Although exemplary embodiments of wearable devices have been specifically described and illustrated herein, many modifications and variations will be apparent to those skilled in the art. Therefore, it should be understood that wearable devices constructed according to the principles of the present disclosure may be implemented in a manner different from that specifically described herein. The present invention is also defined in the following claims and their equivalents.

Claims

1. A wearable device, comprising: Sensing module; and a strap, the strap being attached to the sensing module, The wearable device is configured to be worn by a user, wherein the lower surface of the sensing module is in contact with the user, The strap extends over an upper surface of the sensing module. 2 . The wearable device according to claim 1 , wherein the wearable device is configured to be worn on a wrist of the user.

3. The wearable device according to claim 1 or claim 2, wherein part of the strap is made of an elastomer. 4 . The wearable device of claim 3 , wherein the portion of the strap is pre-formed to conform to the upper surface of the sensing module and both sides of the sensing module. The wearable device of claim 1 , wherein the portion of the strap is a fabric strap. The wearable device of claim 5 , wherein the portion of the strap is an elastic fabric strap.

7. The wearable device of claim 5, wherein the strap is configured to slide longitudinally relative to the sensing module.

8. The wearable device according to claim 7, wherein: The wearable device is configured to be worn on a wrist of the user; and The wearable device is configured to accommodate a wrist circumference of 6.8 inches.

9. The wearable device according to claim 7 or claim 8, wherein: The wearable device is configured to be worn on a wrist of the user; and The wearable device is configured to accommodate a wrist circumference of 6.0 inches.

10. The wearable device according to any one of the preceding claims, wherein the sensing module comprises: a first strap groove, the first strap groove being located on a first side of the sensing module; and A second strap groove is located on a second side of the sensing module, and the second side is opposite to the first side.

11. A wearable device according to any one of the preceding claims, wherein the lower surface of the sensing module comprises a user contact surface.

12. The wearable device according to claim 11, wherein the sensing module comprises: a housing having a first window in a lower surface of the housing; and a partially transparent disk, the partially transparent disk being in the first window, in: The partially transparent disk protrudes below the lower surface of the housing, and The user contact surface is the lower surface of the partially transparent disc.

13. The wearable device of claim 12, further comprising an electrical connector, wherein: The housing further has a second window in the lower surface of the housing; and The electrical connector is located in the second window.

14. The wearable device of claim 12 or claim 13, wherein the partially transparent disk is a glass-metal assembly comprising: a metal plate having a first window, and A first glass window covers the first window of the metal plate.

15. The wearable device according to claim 14, wherein: The first glass window protrudes no more than 100 microns below the lower surface of the metal disk, and The first glass window is recessed within the metal disk by no more than 200 microns.

16. A wearable device according to claim 14 or claim 15, wherein a portion of the first glass window has a speckle contrast parameter less than 0.

7.

17. A wearable device according to any one of claims 14 to 16, wherein: The glass-metal assembly also includes a second glass window; The metal plate further has a second window; and The second glass window covers the second window of the metal plate.

18. The wearable device according to claim 17, wherein: The glass-metal assembly has a first wall that is part of a partition that separates a light emitting region of the sensing module from a light detecting region of the sensing module; The first window of the metal disk opens to the light emitting area; and The second window of the metal disk opens to the light detection area.

19. The wearable device of claim 12, wherein the sensing module further comprises a sensor printed circuit board assembly located on the partially transparent disk, the sensor printed circuit board assembly comprising a spectrophotometer configured to illuminate the user's skin using light transmitted through a first transparent portion of the partially transparent disk, and to detect light that returns to a photodetector of the spectrophotometer through a second transparent portion of the partially transparent disk after being transmitted through the user's tissue.

20. The wearable device according to claim 19, wherein the sensing module further comprises: a battery bracket, the battery bracket being located on the sensor printed circuit board assembly; and a battery, the battery being located on the battery bracket, The battery bracket is configured to protect the battery from damage by components of the sensing module below the battery.

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