Wearable sensing devices and systems, and methods of use

Abstract

Wearable sensors adapted to sense one or more biosignals. The wearable sensors may include a plurality of electrodes. The wearable sensors may be an integrated sensor or made of multiple parts that can be coupled and uncoupled. Methods of manufacturing wearable sensors. Methods of using, placing, and wearing wearable sensors.

Description

WEARABLE SENSING DEVICES AND SYSTEMS, AND METHODS OF USECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 552,012, filed February 9, 2024, the entire disclosure of which is incorporated by reference herein in its entirety for all purposes.

[0002] This application incorporates by reference herein in their entireties the following publications: International Pub. No. WO 2024 / 182777A2; and U.S. Pub. No. US-2024- 0293066-A1.INCORPORATION BY REFERENCE

[0003] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.BACKGROUND

[0004] Wearable sensors are needed that are sized, configured and arranged to be worn on a subject, optionally on the head, and are adapted to sense one or more biosignals from the subject including but not limited to electrical biosignals.SUMMARY

[0005] The disclosure is related to wearable sensors, systems and methods of use and manufacture.

[0006] A first aspect of the disclosure is a wearable sensor that is adapted to sense at least electrical biosignals from a subject. In this aspect, the wearable sensor may include a plurality of electrodes; a flexible patch for placement on a subject; and an electronics package. The flexible patch and the electronics package may each be configured to be coupled for use and uncoupled from the other, wherein the wearable sensor is adapted to sense electrical biosignals from a subject with the plurality of electrodes when worn by the subject.

[0007] In this aspect, the flexible patch optionally includes the plurality of electrodes.

[0008] In this aspect, the electronics package optionally comprises a plurality of pins (optionally conductive, capacitive or ionic), each positioned to interface with one of a plurality of electrodes when the flexible patch and the electronics package are coupled tocreate communication between the plurality of electrodes, the pins, and electronics within the electronics package.

[0009] In this aspect, the electronics package may comprise the plurality of electrodes, the flexible patch may include a plurality of apertures each sized to receive therethrough one of the plurality of electrodes to cause the plurality of electrodes to be exposed on a skin-facing surface of the flexible patch to make contact with the skin of the subject when worn. The plurality of electrodes are optionally attached and integrated as part of the electronics package. Each of the plurality of electrodes optionally include a removable communication interface, each of the removable communication interfaces configured to fit over a pin of the electronics package to be secured to the electronics package, and to be removed from the pin and the electronics package. Removable communication interfaces may be conductively coupled, capacitively coupled, or ionically coupled with the pins.

[0010] In this aspect, the plurality of electrodes may be flexible and may comprise a conductive polymeric material.

[0011] In this aspect, the electronics package further optionally comprises an ear-facing surface that is non-planar with a skin-facing surface, and wherein at least two of the plurality of electrodes are optionally associated with the skin-facing surface and at least one of the plurality of electrodes is optionally associated with the ear-facing surface.

[0012] In this aspect, an ear-facing surface is optionally concave and at least one of the plurality of electrodes that is associated with the ear-facing surface optionally has a concave ear-facing surface.

[0013] In this aspect, the plurality of electrodes each optionally extend proud relative to a wearable sensor surface with which the corresponding electrode is associated.

[0014] In this aspect, the plurality of electrodes are optionally flush with a wearable sensor surface with which the corresponding electrode is associated.

[0015] In this aspect, the plurality of electrodes optionally have a rounded or curved skinfacing surface.

[0016] In this aspect, the flexible patch optionally comprises one or more interfacing surfaces positioned, sized and adapted to interface with one or more surfaces of the electronics package to at least one of stabilize the electronics package relative to the flexible patch or create a water resistant seal between the electronics package and the flexible patch. One or more interfacing surfaces optionally comprise a gasket. One or more interfacing surfaces optionally comprise an outer portion of the flexible patch with one or more materials adapted to be compressed and create a seal as the electronics package is coupled to the flexible patch. An outer portion optionally has a durometer that is higher than a durometer of an adjacentflexible housing portion. One or more interfacing surfaces optionally forms a protruding collar in an outer portion of the flexible patch. One or more interfacing surface optionally comprises one or more magnetic materials adapted to facilitate magnetic coupling between the flexible patch and the electronics package as the electronics package is moved toward the flexible patch.

[0017] In this aspect, the flexible patch optionally includes an adhesive material on at least a portion of a skin-facing surface of the flexible patch. The flexible patch optionally includes a removable cover disposed on the adhesive, the removable cover layer adapted to be removed to expose the adhesive and allow the flexible patch to be adhered to the subject. An optional removable cover may include first and second projections extending beyond an outer edge of the flexible patch, the projection sized to be grasped to facilitate removal of the removable cover. Projections optionally extend from first and second opposing sides of the wearable sensor, optionally wherein opposing sides are side along a length of the wearable sensor, the length greater than a width of the wearable sensor.

[0018] In this aspect, an optional cover optionally includes second buckled sections each adjacent one of first and second projections.

[0019] In this aspect, an optional removable cover optionally does not cover the plurality of electrodes.

[0020] In this aspect, the electronics package optionally includes the plurality of electrodes, a first electrode of which is optionally exposed on a scalp-facing surface of the electronics package, and a second electrode of which is optionally exposed on an ear-facing surface of the electronics package, the scalp-facing surface and the ear-facing surface in a non-planar relationship and the first and second electrodes having skin facing surfaces that are in a non- planar relationship.

[0021] In this aspect, a first of the plurality of electrodes is optionally an ear electrode that is positioned to be in contact with a posterior surface of an ear when the wearable sensor is placed behind an ear on a scalp. In this aspect, the wearable sensor is optionally configured such that an ear electrode is a ground electrode.

[0022] One aspect of the disclosure is a patch (optionally flexible) for use with a wearable sensor that is adapted to sense at least electrical biosignals from a subject.

[0023] In this aspect, the patch may include any one or more features herein, including any one or more features in any one or more of the example, figures, and claims.

[0024] In this aspect, the patch optionally includes one or more interfacing surfaces positioned, sized and adapted to interface with one or more surfaces of an electronics packageto at least one of stabilize the electronics package relative to the flexible patch or create a water resistant seal between the electronics package and the flexible patch.

[0025] In this aspect, the patch optionally comprises a plurality of electrodes, optionally monolithically formed with a patch body.

[0026] One aspect of this disclosure is an electronics package for use with a wearable sensor that is adapted to sense at least electrical biosignals from a subject.

[0027] In this aspect, the electronics package optionally comprises any of the features or aspects in any of claims 1-36, described, or shown herein.

[0028] One aspect of the disclosure is a method of manufacturing a flexible patch for use as part of a wearable sensor.

[0029] In this aspect, the method may include forming (e.g., molding) a flexible patch body that comprise a first material with a second material, the second material (optionally silicone) forming a gasket disposed at least partially around an outer edge of the first material, wherein the forming process (e.g., molding) bonds the first material to the second material and forms the patch body.

[0030] In this aspect, the method may include forming (e.g., molding) a flexible patch body that comprise a first section with a second section, the second region (optionally comprising silicone) forming a gasket disposed at least partially around an outer edge of the first section, wherein the forming (e.g., molding) process bonds the first section to the second section.

[0031] In this aspect, the method may include forming (e.g., molding) a flexible patch body that comprise a first section with a second section, the second section (optionally comprising silicone) forming a collar disposed at least partially around an outer edge of the first section, wherein the forming (e.g., molding) process bonds the first section to the second section.

[0032] In this aspect, the method may include forming any other feature of any one or more patches claimed, described or shown herein.

[0033] One aspect of the disclosure is a method of manufacturing an electronics package for use as part of a wearable sensor.

[0034] In this aspect, the method optionally includes assembling electronics that will be internal to the electronics package.

[0035] In this aspect, the method optionally includes coupling a plurality of pins to the electronics.

[0036] In this aspect, the method optionally includes placing assembled electronics and coupled pins in a mold such that the pins maintain (e.g., elevate) the electronics away from one or more surfaces of the mold.

[0037] In this aspect, the method optionally includes positioning material into the mold such that the material embeds the assembled electronics.

[0038] In this aspect, the method optionally includes causing the material to form an electronics package body.

[0039] In this aspect, the method optionally includes removing the electronics package body from the mold.

[0040] In this aspect, the method may include forming any other feature of any one or more electronics packages claimed, described or shown herein.

[0041] In this aspect, the method optionally includes assembling electronics that will be internal to the electronics package; optionally includes placing the assembled electronics in a mold such that the electronics are away from surfaces of the mold; optionally includes positioning material into the mold such that the material embeds the assembled electronics, wherein the material comprises a first material for a body of the electronics package and a second material for a plurality of electrodes; optionally includes causing the material to form a monolithic electronics package body with integrated electrodes; and optionally includes removing the electronics package body from the mold.

[0042] One aspect of this disclosure is a method of determining a preferred placement for a wearable sensor. Any of the disclosure herein related to determining a preferred placement may be included in this aspect.BRIEF DESCRIPTION OF THE FIGURES

[0011] FIG. 1 illustrates an exemplary electronics package.

[0012] FIG. 2 illustrates an exemplary patch.

[0013] FIGS. 3A and 3B illustrates an exemplary wearable sensor.

[0014] FIG. 4A illustrates an exemplary electronics package.

[0015] FIG. 4B illustrates an exemplary removable communication interface, optionally conductive, capacitive or ionic.

[0016] FIG. 5A illustrates at least a portion of an exemplary wearable sensor.

[0017] FIG. 5B illustrates an exemplary electrode patch.

[0018] FIGS. 6A and 6B illustrate exemplary electrodes.

[0019] FIGS. 7 A and 7B illustrate exemplary behind the ear locations for exemplary wearable sensors.

[0020] FIG. 8 illustrates at least a portion of an exemplary wearable sensor.

[0021] FIG. 9 illustrates at least a portion of an exemplary wearable sensor.

[0022] FIGS. 10 A, 10B and 10C illustrate at least a portion of an exemplary wearable sensor.

[0023] FIGS. 11 A, 1 IB, 11C and 1 ID illustrate at least a portion of an exemplary wearable sensor.

[0024] FIG. 12 illustrates at least a portion of an exemplary wearable sensor including a removable cover.

[0025] FIGS. 13A and 13B illustrate at least a portion of an exemplary wearable sensor including a removable cover.

[0026] FIG. 14 illustrates at least a portion of an exemplary wearable sensor including a removable cover.DETAILED DESCRIPTION

[0027] The disclosure herein, including the devices, systems and methods, is related to one or more of medical technology, wearable sensors, health and well-being, diagnostics, or therapies.

[0028] One aspect of the disclosure is related to wearable sensors, which are optionally sized, configured and arranged to be placed on one or more portions of a head of a subject. In other uses, the wearable sensors may be positioned on other parts of the body, such as the torso or the neck. Wearable sensors herein may be an integrated single device, or they may be sensors that include a plurality of parts that are intended to be coupled and / or uncoupled by a subject. The “wearable sensors” herein may also be referred to as a “wearable,” or a “sensor,” and vice versa.

[0029] Examples of wearable sensors herein are sized, configured and arranged to be worn on the subject’s head at a location behind an ear of the subject, although they may be worn on other parts of the body. A behind the ear location allows the wearable to be discretely worn and reduces the likelihood of being dislodged from the subject.

[0030] FIGS. 1, 2, 3A and 3B illustrate an exemplary wearable sensor 30 that includes patch 20 and electronics package 10. FIGS. 1 and 2 show electronics package 10 and patch 20 separated and uncoupled, while FIGS. 3 A and 3B show them coupled together, forming wearable sensor 30. Wearable sensor 30 is adapted to sense at least electrical biosignals from a subject with a plurality of electrodes 12, and in this example the plurality of electrodes 12 includes electrodes 12a, 12b, 12c and 12d, as shown. Alternative wearables may have a different number of electrodes and / or other electrode arrangements.

[0031] Wearable sensor 30 is an example of a wearable that is sized and configured for optional placement at a behind the ear location, examples of which are described in WO 2024 / 182777 A2, such as in FIG. 4 of WO 2024 / 182777 A2 (fully incorporated by reference herein), although wearable sensor 30 may be placed at other locations.

[0032] Wearable sensor 30 includes patch 20, which is preferably but optionally flexible, and may be made of one or more materials (e.g., one or more polymeric materials). Patch 20 includes a scalp-facing surface 23, although scalp-facing surface 23 is not in direct contact with the subject, such as if an adhesive or adhesive layer is disposed on surface 23 to secure the sensor to the skin. Alternatively, scalp-facing surface 23 may be considered to include an adhesive layer of the patch. As set forth herein, the scalp-facing surface may be placed on parts of the body, so the phrase “scalp-facing” is exemplary and not-limiting.

[0033] Wearable sensor 30 also includes an electronics package 10, any of which may alternatively be referred to herein as an electronics member or an electronics housing. Electronics packages herein generally includes one or more components (such as any described in WO 2024 / 182777 A2), such as, for example only, a power source (e.g., a removable and / or rechargeable battery); one or more processors; one or more control circuits; ASIC(s); operational amplifiers; A / D converter; an antenna; other electrical hardware; conductors for coupling electrodes to one or more electrical components; a blue tooth module, etc., which alone or together may be described herein as “electronics”. In examples herein, the electronics may be overmolded within body 11 of the electronics package 10.

[0034] In this example, patch 20 includes a plurality of apertures 22 (22a, 22b and 22c in this example), each sized, positioned and configured to receive therein (or therethrough) one of the plurality of electrodes 12a, 12b and 12c when electronics package 10 is coupled to patch 20. In this example, electrode 12d faces a different direction than electrodes 12a, 12b and 12c, and electrode 12d is not disposed within a patch aperture 22. Alternatively stated, patch 20, in this example, does not include an aperture to receive electrode 12d. When sensor is optionally placed behind an ear with electrodes 12a, 12b, and 12c on the skin / scalp, electrodes 12d is in a position to contact the back or posterior ear. In alternative designs, the patch may also include an ear-facing surface or wall that is non-planar with scalp-facing surface 23, wherein the ear-facing surface / wall includes an elongate aperture sized to receive electrode 12d therein / therethrough.

[0035] Patch 20 and electronics package 10 are each configured to be coupled to one another for use (as shown in FIGS. 3 A and 3B) to be secured to the user and sense electrical biosignals from a subject using the plurality of electrodes 12 when worn by the subject. Wearable sensor 30, while not specifically shown in FIGS. 1-3B, may also include other types of sensors that are adapted to sense non-electrical biosignals (e.g., optical sensors such as photodiodes (e.g., for PPG), pressure sensors, etc.), examples of which are described herein and incorporated by reference. Patch 20 may also include a collar / gasket, which is described in the example of FIGS. 5 A and 5B.

[0036] In the example in FIGS. 1-3B, electrodes 12 are integrated as part of the electronics package 10, specifically to the body or housing 11 of electronics package, and may be molded with the body 11 of package 10. As an example only, electrodes 12 may comprise a conductive flexible material (e.g., conductive rubber) that is molded as part of the body 11 of the electronics package 10.

[0037] Body or housing 11 of electronics package 10 is preferably but optionally non-rigid, with some flexibility to help conform the wearable 30 to the subject. Body 11 of the package 10 may be molded, for example, with components of the electronics package 10 molded into the body 11 such that they are contained within the outer profile (surfaces) of body 11, at least some of which are in communication with the electrodes.

[0038] In this and other examples herein, an ear-facing surface 14 of wearable sensor 30 (in this particular example, ear-facing surface 14 is part of electronics package body 11) and electrode 12d have concave configurations, as shown in FIGS. 1, 3A and 3B. The concave configuration can help electrode 12d contact a posterior region of the subject’s ear when the wearable 30 is worn behind the ear, and which is described in more detail herein. Electrode 12d is sized, positioned, and configured to make contact with a posterior region of an ear of the subject, and may be used as a passive or active “ear” electrode to sense electrical biosignals and / or deliver electrical signals to the subject. FIGS. 7A and 7B illustrate exemplary behind the ear locations for wearable sensors herein, including wearable sensor 30, and while not visible in the figures, an optional ear electrode (e.g., electrode 12d) is in contact with a posterior region of the ear (“PRE”), as shown.

[0039] Wearable sensor 30 is an example of a wearable sensor that comprises an ear-facing surface 14 that is non-planar with a scalp-facing surface 23, and wherein at least two of the plurality of electrodes 12 are associated with (optionally extending proud from) the scalpfacing surface (e.g., 12a, 12b, 12c) and at least one of the plurality of electrodes (e.g., 12d) is associated with (optionally extending proud from) the ear-facing surface 14. In this example, electronics package 10 comprises the ear-facing surface 14, and patch 20 comprises the scalpfacing surface 23. In alternative “integrated” designs (wherein a patch and electronics package are more permanently integrated, such as if they are molded together), an ear facing surface and a scalp facing surface may both be considered part of the integrated wearable sensor.

[0040] While optional, electrodes 12a, 12b, 12c and 12 of wearable sensor 30 extend proud relative to one of the surfaces of the wearable with which they are associated, as shown in FIGS. 3A and 3B. In this example, electrodes 12a, 12b, and 12c extend proud relative to scalp-facing surface 23, and also have a generally rounded outer configuration where they areexposed through apertures 22a, 22b, and 22c, while the degree of curvature may vary. Electrode 12d in this example extends proud relative to ear-facing surface 14.

[0041] Scalp-facing surface 23 may also be considered to be a bottom surface or bottom portion generally of wearable sensor 30, while a surface opposite or opposing bottom surface / portion 23 may be considered a top surface or top portion generally of wearable sensor 30. In this example, the concave surface 14 and opposing convex surface can be considered side portions or side surfaces of wearable sensor 30, each of which extend between top and bottom portions / surfaces.

[0042] FIG. 4A illustrates an exemplary electronics package 40 that may include any feature of electronics package 10 from FIGS. 1-3B unless indicated to the contrary herein. In this example, each of the plurality of electrodes 42 (42a, 42b, 42c and 42d in this example) are configured to be easily attached and removed (uncoupled) from the electronic package 40, such as for replacing, cleaning, or inspecting. Electrodes 42a, 42b and 42c in this example are considered as communicative “covers” (optionally conductive communicative covers) that, in this example, have an optional general bullet shape with an internal channel (shown as channel 48 in FIG. 4B) adapted to fit over one of the pins 49a, 49b and 49c (the pins 49a, 49b, and 49c are optionally conductive pins). Electrodes 42a, 42b and 42c also have optional rounded skin-contacting ends, as shown. Electrode 42d is also adapted to be easily coupled and uncoupled from the package 40, and which includes two pins other either end portion as shown. The electrode 42d pins are each sized and configured to fit into corresponding openings on the ear-facing surface of the electronics package, as shown, to secure electrode 42d to body 41 of package 40. Electrodes 42 may be generally flexible and comprise (or made of) one or more conductive materials, and electrodes 42a, 42b and 42c include an internal channel 48 (FIG. 4B) sized and configured to snugly fit over pins 49. This example allows the electrodes to be replaced or cleaned as / if needed, such as if the electrode(s) need cleaning and / or wear out or even on a somewhat regular basis to ensure the integrity and proper functioning of the electrodes. Electronics package 40 can be part of a wearable sensor that is adapted to be coupled to a flexible patch, such as patch 20 shown in FIGS. 2, 3A and 3B. The electrodes 42 may be made from a variety of different types of conductive material. The wearable sensor can be adapted such that any of the electrodes may be used to sense / record (e.g., passive), stimulate (e.g., active), or any combination thereof.

[0043] FIG. 5A illustrates an exemplary wearable sensor 50 that includes an electronics package 60 and flexible patch 70. Flexible patch 70, unlike patch 2 shown in FIG. 2, includes or is integrated with a plurality of electrodes 72 (72a, 72b and 72c in this example) that are integrated into patch body 73 and not designed to be removed (at least not regularly duringuse). Electronics package 60 includes a plurality of pins 69 (69a, 69b and 69c in this example) that are sized to snugly fit into an internal chamber or channel 79 of each electrode, which are illustrated in FIGS. 6 A and 6B. The electrodes 72 are conductive and may be made from a variety of materials, and when pins 69 are coupled with electrodes 72, the electrodes 72 can electrically communicate with electronics within electronics package 60.

[0044] Pins 69 and electrode channels 79 may each be sized and configured such that when the pins and the electrodes are interfaced, the interface (e.g., frictional fit, magnetic) helps couple the electronics package 60 with the patch 70 and helps maintain the coupling between the two. Additionally or alternatively, any of the patches herein (e.g., patch 70) optionally includes one or more interfacing surfaces that are positioned, sized and adapted to interface with one or more corresponding surfaces of the electronics package to at least one of stabilize the electronics package relative to the flexible patch or create a water resistant seal between the electronics package and the flexible patch. In this context, patch 70 includes a collar and / or gasket 71, which in this example is an outer portion of patch body 73, as shown. Collar 71 can include one or more materials that are adapted to be compressed when electronics package 60 is coupled to patch 70, which creates a water-resistant seal between the package 60 and patch 70. A water resistant seal allows the wearable sensor to be worn more consistently without having to be removed (e.g., for bathing, in the rain, etc.), which provides for more reliable recording of electrical biosignals. A collar / gasket 71 may optionally be a portion of the patch body 73 with a higher durometer material than a more centrally located portion of the patch body 73, and when compressed, provide for at least some mechanical stability between the two components and / or or fluid resistance between the patch and package to prevent fluid entering the electronics package. In the example shown, collar 71 extends around an outer edge of the patch, and is a raised region relative to the adjacent patch body. Collar 71 is on the side of the patch that faces the electronics package (when they are coupled) and not the scalp-facing side 73 of the patch 70.

[0045] Any one or more features from any other wearable sensor herein may be incorporated into wearable sensor 50 unless indicated to the contrary herein.

[0046] Any of wearable sensors herein may include a patch and an electronics package that are adapted to be coupled at least partially with magnetic force, which may be in addition or alternatively to any other type of coupling forces. For example, the package and the patch may include one or more components that magnetically attract one another to help stabilize the patch and package relative to one another.

[0047] In this example, the collar / package interface is an example of coupling means to at least one of stabilize the electronics package relative to the flexible patch or create a water resistant seal between the electronics package and the flexible patch.

[0048] One aspect of the disclosure is a method of making a flexible patch with a collar / gasket. Depending on the materials used for the patch body and the collar, it may be difficult to attach them together after the individual parts have been formed (e.g., cured). For example, a silicone material used as the gasket may be difficult to attach to a patch body depending on the material. Silicones are typically difficult to bond well to most materials, particularly without surface treatments. Methods of manufacturing the patches herein may include forming (e.g., curing) the main body of the patch with the collar / gasket material at the same time. For example, the collar (e.g., a silicone material) may be molded with the main body of the patch, which can enhance the bonding between the two materials. Additionally, patch electrodes (e.g., as shown in FIGS. 5A and 5B) may also be formed in the same manner (e.g., molded) at the same time the main patch body and the collar are formed time (e.g., in the same molding process in the same mold).

[0049] The electronics packages herein (e.g., packages 10, 40, 60) may be manufactured using an overmolding process with the one or more electronics molded within (embedded) within the outer profile / surfaces of the body 61. In the example shown in FIGS. 4A and 5 A, a method of manufacturing can include assembling the internal electronics and attaching conductive pins 49 and 69 to the electronics. After assembling the electronics, the electronics assembly can then be placed in a mold in which the material of the body 61 can be injected and formed around the internal electronics. The pins can act to keep the internal electronics elevated relative to a surface of the mold, allowing the injection material of body 61 to be easily injected and form the body 61 from which the pins extend, thereby forming a monolithic body 61 (single body 61 not requiring two components attached together). The body of the electronics packages herein may be made from one or more materials that have some degree of flexibility, including, for example only, silicone, santoprene (a TPV), or a thermoplastic polyurethane (PU).

[0050] FIGS. 8, 9, 10A, 10B, and 10C illustrate exemplary additional wearable sensors and features, any features of which may be incorporated into any of the other wearable sensors herein, and vice versa.

[0100] FIG. 8 illustrates an exemplary wearable sensor 80. As shown in FIG. 8, wearable sensor 80 includes patch 81 (preferably but optionally flexible) and electronics package 82 (shown uncoupled). Patch 81 may include any of the features from any of the patches described herein, and electronics package 82 may include any of the features from any of theelectronics packages herein. Patch 81 includes a plurality of electrodes 83 (83a, 83b, 83c in this example) secured to patch body 84 (similar to patch 70 in FIGS. 5A and 5B). Electronics package 82 and patch 81 are each sized, configured and adapted to be releasably coupled together to facilitate communication between the electrodes and electronics package 82. Wearable sensor 80 may include any feature that facilitates coupling and / or water resistance between the patch and the electronics package (e.g., a gasket / collar; magnetic coupling features). In this example, electronics package 82 includes a plurality of electrode wells or recessed regions 85 (only one is labeled for clarity), each sized and configured to receive at least partially therein one of the plurality of electrodes 83. Wells 85 may each include a conductive member or region 86 (only one is labeled for clarity) within the well that are electrically coupled to internal electronics (e.g., an ASIC) and are sized, positioned and configured to electrically couple to the electrodes when the patch is coupled to the electronics package and the electrodes are positioned inside the wells. As an example, conductive members 86 may be or have an annular member formed on an inner surface of wells 85, which may be flexible annular conductive member or material formed as part of the well during a molding process, for example only.

[0101] FIG. 9 illustrates an exemplary wearable sensor 90. As shown in FIG. 9, wearable sensor 90 includes patch 91 and electronics package 92. FIG. 9 shows the patch and the electronics module uncoupled. Patch 91 may include any of the features from any of the patches described herein, and electronics package 92 may include any of the features from any of the electronics packages herein. Sensor 90 is similar to sensor 80 in FIG. 8 (and parts similarly labeled (e.g., 92 / 82) are incorporated into the description of FIG. 9), and is further adapted with optical sensing functionality, such as for photoplethysmography (“PPG”). Electronics package 92 may include one or more light emitters (e.g., LEDs) and one or more light sensors (e.g., photodiodes), together labeled as optical components 99 to emit light and sense reflected light to facilitate measuring one or more biosignals of the wearer (e.g., HR, HRV, blood volume, concentration of molecule(s) in blood). In this example, electrodes 93 (e.g., 93a, 93b, 93c) may have a ring or annular configuration, as shown, with a transparent member or region within the ring electrodes to allow light to pass therethrough (both emitted and reflected light). The transparent region(s) of the electrode(s) facilitates optical sensing therethrough, and the conductive electrode material facilitates electrical sensing. One or more electrodes may have a transparent region therein, depending on the optical needs of the system, and optionally all of the plurality of the electrodes comprise a transparent internal region. Optionally, less than all of the electrodes may have an internal transparent member (e.g., one or more electrodes may not include any transparent region / member).

[0102] FIGS. 10A, 10B, and IOC illustrate additional exemplary features of exemplary wearable sensors herein, including those shown in FIGS. 8 and 9, and may incorporate any of the features of any of the wearable sensors herein, and vice versa. FIG. 10A illustrates wearable sensor 100 with electronics package 102 coupled to patch 101. Electrodes 103a, 103b, and 103c are shown integrated into patch 101, and may be placed in electrical communication to electronics package 102. As shown in FIGS. 10A and 10C, the skin facing surface of patch 101 may have a curvature formed therein (e.g., during molding), which may help the sensor and electrodes conform to tissue and help secure the wearable to the subject depending on the location, such as a behind an ear location as described herein. The curvature may optionally be optimized as desired, and may optionally be specifically formed for the particular skin geometry of a user, depending on the desired placement location. In addition or alternatively, curvature may be achieved or facilitated by varying the height of the electrodes, wherein the height of the electrode is considered the distance that the electrodes extends from the skin-facing surface of patch 101. For example, a first electrode extending further away from or out of the skin-facing surface than a second electrode has a greater height than the first electrode in this context. FIG. 10B illustrates a top view of patch 101 and FIG. 10C illustrates a side view when coupled, both of which include merely exemplary dimensions.

[0100] Wearable sensors herein may include an optional ear electrode, which is positioned to be in contact with a posterior region of the ear when the wearable sensor is worn in a behind the ear position. Wearables sensors shown in FIGS. 1, 3A, 3B, 4A, 5A and 11 A, 1 IB, 11C and 1 ID include exemplary ear electrodes, an exemplary position for placement of which is shown in FIGS. 7A and 7B and in the references incorporated by reference herein. Wearable sensor 1100 shown in FIGS. 11 A-l ID may include any of the features from any of the wearable sensors herein, and vice versa. For example, wearable sensor 1100 may be an integrated one-piece design or it may include any of the combination of patches and electronics members in FIGS. 1-10C, for example. Wearable sensor 1100 includes a body 1104, ear electrode 1102, optional sensor 1105 (e.g., a touch sensor), electrodes 1101 (three shown), adhesive layer 1103, and optional patch 1107 that may be adapted to be uncoupled from an electronics member (as described in some examples herein). Wearable sensor 1100 may be configured so any one or more of electrodes 1102 and 1101 may be a passive electrode or an active electrode. Ear electrode 1102 is positioned and configured with a concave curved surface to interface with or substantially interface with a proximal curved region of the ear. Wearable sensor 1100 may optionally be configured so that ear electrode 1102 functions as a ground electrode for the device. The ear electrode has a skin-facingsurface that is facing a different direction than skin-facing surfaces of each of electrodes 1101, wherein electrodes 1101 are positioned to interface with a surface of the scalp when the wearable is worn behind an ear of a subject with typical anatomy. In this example, electrode 1102 has a skin-facing surface that is oriented 90 degrees or about 90 degrees from the orientations of the skin-facing surfaces of electrodes 1101, as shown. In this example, ear electrode 1102 is associated with a first surface of the wearable sensor 1100 while electrodes 1101 are associated with second surface of the wearable sensor 1100, the first and second surfaces of wearable sensor facing different directions, as shown (i.e., non-planar). That may be situated at angles other than 90 degrees, depending on the desired placement location. The ear-facing surface of the body of the wearable sensor has a concave curved surface as well, as shown. The dimensions shown in FIGS. 11C and 1 ID are meant to be illustrative and nonlimiting. The wearable sensor shown in FIGS. 11 A-l ID may include any other internal electronic component of any of the wearable sensors herein (e.g., communication module, battery, memory, microcontroller, A / D converter, op-amp, antenna, etc.). In this example, the sensor length (e.g., 30 mm) is greater than the sensor width (e.g., 5 mm), and is an example of a length that is at least twice as great as a width, and is also an example of a length that is at least three time as great as the width, and is also an example of a length at least four times as great as the width, any of which may help with placement behind an ear.

[0101] In this or any other example herein, any of the electrodes may optionally be carbon printed electrodes or other conductive flexible and / or polymeric material.

[0102] Wearable 1100 includes sensor 1105 (which may be the same or similar to sensor 19 shown in FIG. 3B, and sensor 49 shown in FIG. 4A), which may also be incorporated into any other wearable sensor herein. Sensor 1105 may be a touch sensor or a proximity sensor, for example. Sensor 1105 may be adapted to respond to a user actuating sensor 1105. In some examples, actuating sensor 1105 can create an input to the device so the user can communicate a user event or input to the wearable sensor. User events in this context can refer to an event that the wearable sensor or system can track or associate with any of the sensed biosignals. For example only, a user event can be an event of consuming food (which includes liquid), a feeling of stress, taking medication, etc., the timing of which may also be tracked by the sensor or system (a time-stamp). Sensor 1105 may thus serve as an event tracker and / or time-stamp.

[0103] Sensor 1105 is in communication with one or internal electronic components of the wearable sensor to facilitate event tracking when the user interacts with or actuates sensor 1105. Sensor 1105 may be mechanical or non-mechanical. If sensor 1105 is mechanical, the wearable may include a seal associated with the sensor 1105 to maintain water resistancebetween the sensor 1105 and the rest of the wearable sensor. Sensor 1105 may be conductive (e.g., gold plated copper) such that a user touching sensor 1105 creates an electrical connection. For example only, the wearable sensor may include a continuity sensor that senses when a user touches sensor 1105, completing a circuit, which can trigger the event tracker and / or time-stamp. Sensor 1105 may be or comprise other types of sensors to allow the user to actuate the sensor to indicate an event to the device or system.

[0104] Any of the electrodes herein may optionally (not limiting) be printed carbon electrodes, which are electrodes made from carbon-based materials, and which can be created through printed electronics techniques, such as screen printing or inkjet printing, onto a substrate. The primary material used for the electrode may be carbon, which is conductive and can be tailored to meet specific requirements (e.g., conductivity, mechanical properties, chemical resistance). Carbon materials can optionally include graphite, carbon nanotubes, graphene, and carbon black. Printing methods such as screen printing, inkjet printing, or flexographic printing may be used to allow for precise control over electrode patterns and sizes. The printing process allows the creation of flexible, lightweight electrodes.

[0105] Any of the wearable sensors herein optionally has a length of 15 mm - 55 mm, optionally a width of 3 mm - 25 mm, and optionally a height of 1 mm to 8 mm, exemplary dimensions of which are shown in figures herein.

[0106] Any of the patches herein may be intended to be used so that the patch is temporarily used for some period of time (e.g., 7 days, 10 days, 20 days, etc.) and then removed and replaced with a new patch. The patch in this context may be considered a short-term or disposable patch. For example, in cases of skin sensitivities, it may be preferred to avoid relatively prolonged patch wearing, in which case the patch may be replaced periodically to minimize the likelihood of skin irritation or other skin issues that may occur when worn for longer times. Kits may include a plurality of electrode patches (similar to a bandage package).

[0107] An additional aspect of this disclosure includes devices, systems and methods that are adapted to determine, or help the user determine, a placement location for the wearable sensor that is better or more preferred than other locations on the body. One or more placement locations may be considered preferred to one or more other locations for a variety of reasons, such as one or more locations that will detect less noise or unwanted biosignals from the subject. For example only, wearable sensors herein may be used to detect certain types of brain activity signals, while depending on the location, the wearable sensor may also sense electrical signals from sources other than brain activity. The sensed signal may be, depending on placement, a composite of numerous electrical activities originating fromvarious sources, such as brain activity, muscle activity, vasculature activity, eye movements, skin conductance and sweating, and external interference. For example, electrical activity associated with muscle contraction can be recorded (electromyography (“EMG”)). When muscles of the face, scalp, or neck (e.g., those involved in blinking or clenching the jaw) contract, the associated electrical signals can be detected by scalp electrodes. This activity is often much larger in amplitude than brain activity. With respect to the vasculature, pulsing of an underlying artery may cause small movements of the scalp electrodes, which coincides with the cardiac cycle. The pulsations can cause small shifts in the relative position of the electrode, leading to potential changes that may be detected by wearable sensors herein. With respect to eye movements, electrooculography (EOG) captures the electrical activity resulting from eye movements. When the eyes move or blink, an electrical potential is generated, which can be detected by nearby scalp electrodes. With respect to skin conductance and sweating, the skin's electrical properties can change due to sweating or other factors, leading to small shifts in detected voltage. Electrical activity generated by the brain may be small compared to the overall voltage measured by wearable sensors. Brain waves, for instance, are typically in the range of microvolts. In contrast, muscle activity can produce signals that are much larger than brain activity signals.

[0003] Determining one or more wearable sensor locations that are preferred to one or more other possible locations can include initiating a placement mode, which may be performed prior to recording signals that are used to determine, measure and / or predict one or more aspects of the subject’s health (for example only, predicting a glucose state or other indicator of metabolic health).

[0103] One aspect of the disclosure is systems that are adapted to automatically determine or indicate a preferred placement of the wearable sensor. In this context, a preferred placement does not require a placement that is better than any other placement, but rather may be a placement that meets one or more thresholds or criteria. For example, a preferred placement may be, in some implementations, considered satisfactory compared with less than satisfactory sensor positions. In some implementations, the system may have a binary approach, where a placement is either preferred or non-preferred (yes or no). In some implementations, the system may have more than two categories, such as three categories, an example of which is green light (preferred placement), yellow light (acceptable placement), and red light (least preferred, or unacceptable). Any of the systems herein may optionally be configured with any number of wearable sensor placement test conditions or criteria that may be desired.

[0104] In this aspect, the wearable sensor itself or in use with a personal device (e.g. watch, smartphone, etc.) may be configured to determine a preferred location. For example, the method may occur solely with the use of a wearable sensor, or a wearable sensor may communicate with a personal device, which has stored thereon executable instructions to be at least partially involved in the preferred placement determination / testing process.

[0105] In some implementations, it may be preferred that the wearable sensor and / or the system determine a preferred location prior to the user adhering the wearable to the skin. This may be advantageous in that it can avoid having to repeatedly adhere and then remove the wearable sensor from the skin, which may cause undesired skin irritation due to an adhesive. Wearable devices herein optionally include a cover or cover layer over an adhesive or adhesive layer, wherein the cover is maintained over the adhesive during the preferred placement determination step (the cover is not yet removed). This avoids the need to adhere, remove, then re-adhere the wearable sensor in a new location each time the placement is tested as part of the preferred placement (also referred to as a preferred location) process.

[0106] In an exemplary use, the subject can initiate a placement test, either by interacting with a personal device and / or wearable sensor, positioning the wearable sensor in a first location, and moving the wearable sensor until the system and / or wearable device provides an output that indicates on preferred placement, depending on the placement categories or test cases. This may be considered a “continuous” placement mode where the system is continuously or near-continuously actively testing preferred placement based on recorded signals from the wearable sensor.

[0107] In an exemplary use, the system may be adapted such that the subject places the wearable sensor in a first location, and then initiates a preferred placement mode, which activates the mode to test the placement, and provides an output indicative of assessment of sensor placement based on recorded signals from the wearable sensor.

[0108] During the location testing, the user can keep the cover on the wearable sensor while the user holds the wearable such that the sensors (e.g., electrodes) make contact with the body of the user, allowing the electrodes to detect electrical biosignals during the location testing process. By way of example, in some implementations the location testing method can include the use of impedance spectroscopy, a technique used to measure and analyze the electrical impedance of the wearable over a range of frequencies (i.e., a frequency sweep). In general, in impedance spectroscopy, a small AC signal is applied to a system (e.g., an electrochemical cell, a biological tissue, or a material), and the resulting voltage and current are measured across a range of frequencies. By analyzing how the impedance varies with frequency, the readings provide information into various properties of the system, such as itselectrical conductivity, dielectric properties, and behavior of charge transfer. The detected electrical biosignals can vary depending on the position of the wearable sensor, which can influence the impedance measurements, such as if there is a significant amount of artifact from muscle activity (e.g., neck muscle). With some systems herein that are intended to record at least brain activity signals, certain sensor placements on the body may produce more reliable measurements than other locations where more noise / artifact (other unwanted signals) is recorded.

[0109] The user may be alerted to the results of the preferred location test in a variety of ways, which may involve an output created by a personal device (e.g., smartphone app) and / or the wearable sensor. In some implementations, the wearable sensor can initiate an audible and / or vibratory output to indicate whether the wearable sensor is in a preferred position. For example only, a wearable sensor may vibrate when in a preferred location but not vibrate when not in a preferred location. For example only, a wearable sensor may emit beeps during the process, where the beeps are more frequent when in a preferred location compared to a less or non-preferred location.

[0110] In some implementations, a personal device App may provide an output in response to the placement testing. For example, an App may include a mode that visually presents an output, such as visually displaying on a screen of the personal device a red icon for a nonpreferred location, or a green icon for a preferred location. For example only, an App may be adapted to cause the personal device to vibrate when the wearable sensor is in a preferred location but not vibrate when not in a preferred location. Any other suitable type of output may be used to indicate to the user a preferred location (versus a non-preferred location). [OHl] Once or after a location test determines that the wearable sensor is in a preferred location, the user may then maintain the wearable sensor in that location and remove the cover and adhere the wearable sensor to the skin. Advantageously, the wearable sensor cover can be configured so that it can be removed easily without the user having to move, or meaningful move, the wearable sensor from the preferred location. FIG. 12 illustrates a merely exemplary cover with one or more perforated sections S (optionally linear as in this example) along its length, and which is configured to be removed relatively easily when pulled in a first direction with one or more cover tabs “T” with a force “F” generally aligned with at least some of the perforated sections, partially due to the forces imparted on the plurality of perforated sections from the protruding electrodes and in an direction opposite or generally opposite to the removal forces applied by the user.

[0112] FIGS. 13A (side view) and 13B (bottom view) illustrates a merely exemplary cover design that is adapted to be removed without substantially moving the wearable sensor 1300from the preferred location. In this example, a cover includes first and second cover sections 1302a and 1302b, one on each side of the wearable and each on an adhesive layer as shown. Each section 1302a and 1302b includes an inner layer 1304 (only inner layer 1304a is labeled for clarity) and an outer section 1303a and 1303b that extends further beyond the periphery of the sensor body to allow the edge of sections 1303a and 1303b to be grasped and pulled by the user with a force “F”, which peels the cover sections from and exposes the adhesive layer. In this example, the cover includes cutout for the electrodes to stick through so they can make contact with the skin during preferred location testing (example electrodes 1301 shown in the bottom view of FIG. 13B). In the bottom view of FIG. 13B, outer cover sections 1303a and 1303b are shown extending further than edges 1309a and 1309b of the body of the wearable sensor (shown in dotted lines). In this example, the outer sections 1303a and 1303b are considered to have tabs or projections that allow them to be grasped and pulled by the user while the wearable sensor is held against the body of the user. The cover may have other configurations that allow it to be removed without moving (or without significantly moving) the wearable sensor from the preferred location.

[0113] FIG. 14 illustrates a merely exemplary cover design that is adapted to be removed without substantially moving the wearable sensor 1400 from the preferred location. Any one or more features of any of the wearables herein can be incorporated with wearable sensor 1400. For example, four electrodes are shown, and one is an ear electrode. In this example, the cover 1401 includes tabs or projections 1401a and 1401b on two sides of the wearable, extending beyond the outer edge of wearable 1400 to allow the user to grasp and pull on tabs 1401a and 1401b. Cover 1401 includes first and second buckled sections 1402 (only one is labeled), which straighten out (become unbuckled) when the tabs are pulled to the sides, then force is applied parallel to the adhesive surface to remove the backing / cover. Cover 1401 can include a separation region 1402 adapted to easily separate when the tabs are pulled, with each cover side being removed from one side of the wearable.

[0114] Any of the wearable sensors herein may optionally not include a removable backing or cover over the adhesive. In these examples, the adhesive may be a pressure-sensitive material. In use, slightly protruding electrodes can allow electrodes to contact the skin while preventing the adhesive from contacting the skin and prevent sticking. Additionally, the pressure sensitivity of the adhesive minimizes sticking even if some incidental contact is made. In use, the user can make contact between the electrodes and the skin and can scan for a preferred location, and once a preferred location is detected, the user can then apply pressure toward the skin to facilitate the adhesive (and the wearable) sticking to the subject.

[0115] In an exemplary use, prior to removing a backing / cover that covers the adhesive, the subject places the wearable at a location behind the ear and initiate a process that determines a relatively sufficient location (the sensor does not stick to the skin because the cover is not yet removed). The process may be initiated by the user by providing input to an App to start the process or pushing a button on the wearable sensor. Recordings can be made across a wide range of frequencies via the electrodes, and impedance can be analyzed (e.g., via the App or performed solely on the wearable sensor) to determine if the sensor is in a less than optimal (or otherwise inadequate) location, and optionally with instructions to move the sensor to a slightly different location and again record and analyze the impedance measurements. This process may be repeated a plurality of times until the system determines the sensor is in an adequate location, which may be provided to the user indicating the sensor should be placed at the preferred location. Alternatively, the system may optionally be adapted to analyze the impedance measurements from a plurality of different locations, and use all of the information to determine a preferred location. The user may then remove the covering, which exposes the adhesive, and adhere the wearable sensor to the subject at the preferred location.

[0116] Any App herein may be adapted to store in a memory one or more preferred sensor locations and can show the location on a visual representation of the body (e.g., a region including an ear and scalp) area so the user can be reminded where to put the sensor, such as if the sensor is removed for replacement, recharging, and / or cleaning. Some patient-to-patient anatomical variability may make personalized preferred wearable sensor location quite important or even critical.

[0117] In this aspect in which the optional initial sensor position is analyzed with impedance measurements, the electrodes stay exposed through electrode openings in the cover, allowing the user to move the sensor around while the system obtains measurements. An exemplary benefit to this approach is that impedance measurements can be obtained relatively quickly, and one or more preferred wearable sensor locations prior to adhesion can thus be determined relatively quickly.

[0118] Any of the adhesives herein may optionally comprise one or more silicone materials and / or may be pressure-sensitive adhesive material, described elsewhere herein.

[0119] Any of the wearable sensors (including any of the electronics packages) herein may include one or more flexible printed circuit board(s) (PCB(s)). Flex PCBs herein may comprise a thin flexible material (e.g., a polyimide or a polyester material). The flex PCBs are adapted to be flexible to allow the portion(s) that include the PCB to have at least some degree of flexibility to help the wearable sensor have some degree of flexibility to helpconform to the body of the subject. Flex PCBs herein may be single-sided, double-sided, or multi-layered, for example.

[0120] Any of the wearable sensors herein (including any of the electronics packages herein) may include a rechargeable battery (alternatively a battery may not be configured to be rechargeable). For example, any of the electronics packages may be removed or detached from a patch and placed in a recharging station adapted to recharge the battery, and which the electronics package reattached to the same or a different patch. Alternatively, Any of the wearable sensors herein that include a detachable electronics member may include a battery that is not adapted to be recharged, but may include a battery that can be removable from the body of the electronics member and replaced with a new battery to provide power to the wearable device. In these examples, the system may be considered to be a three-piece or three-component system, with a flexible patch, a detachable electronics member or electronics member, and a battery removable from the electronics package that can be replaced with a new battery.

[0121] One aspect of the disclosure is a recharging and / or cleaning station sized and configured to recharge optionally rechargeable batteries of the wearable sensors herein. For designs in which the electronics can be uncoupled from a patch, the electronics package may be positioned relative to the charging station to recharge a battery in the electronics package. For example, an electronics member may be detached from the patch and placed in a case or housing that is adapted to recharge the battery. Alternatively, the entire wearable sensor may be placed in a charging station to recharge a rechargeable battery. Recharging devices may be adapted so that one or more electrodes of the wearable sensors herein is the contact points for the charging system to recharge the battery.

[0122] One aspect of this disclosure is a cleaning station sized and configured to clean / sterilize one or more aspects of the wearable sensor, such as a patch and / or electronics package. For example, a patch may be removed from the subject and placed within a cleaning case. A cleaning station may implement UV light to sanitize and disinfect the patch, for example. A cleaning case in this aspect may be similar to cleaning cases for orthodontic aligners, and may include any known features of such cleaning cases. For example, cleaning cases herein may implement ultrasonic waves to gently remove plaque, bacteria, and other debris from patches without damaging them (including patches that may or may not have electrodes integrated into them). Cleaning stations may implement both UV light to sanitize as well as ultrasound waves to gently remove debris. Cleaning stations can optionally be used to clean or regenerate electrodes.

[0123] Any of the recharging stations herein may also be adapted with one or more diagnostic and / or calibration functions. For example, the station can be configured as a small signal generator to send a signal to the wearable and detect if one or more components of the wearable sensor are functioning correctly, or if they may need to be replaced. For example only, the station may send a particular signal to the electronics package at a particular frequency and check if it detects that signal at that frequency. Additionally, for example only, an impedance test on the wearable sensor can indicate if one or more electrodes are breaking down and may need to be replaced. The station may be configured for other types of diagnostic and / or calibration tests as well.

[0124] Any of the recharging stations herein may be integrated with any of the cleaning stations herein (as well as with any diagnostic functionality), and may be considered an integrated recharging / cleaning / diagnostic station. For example only, a case may include a recharging / diagnostics portion for recharging a rechargeable battery of the electronics member, a separate cleaning portion for cleaning a patch and / or electrodes. The two portions may be separated by a physical divider, and may be configured to interface with the configuration of the electronics member and / or patch.

[0125] One aspect of this disclosure is recharging a wearable sensor while the wearable sensor is being worn (e.g., on the head). For example only, the wearable sensor may include first and second electrodes on an outer, non-skin-facing, surface that could be electrically coupled to a recharger. Charging while wearing may be wireless of wired.

[0126] Any of the molded materials (e.g., any of the electronics packages herein) may include (e.g., blending them into a base material such as silicone) metal particles to create an electromagnetic (EM) shield that acts as a protective barrier or material that blocks or reduces the transmission of electromagnetic fields (EMF) from external sources (i.e., reduces noise). EM shielding is used to protect sensitive electronic devices, components, or environments from interference caused by electromagnetic radiation, or to safeguard individuals from potential health risks related to EMF exposure. With any of the wearable sensors herein, metal particles may optionally be blended into the electronics package body material (e.g., silicone) and not a patch.

[0127] An additional aspect of the disclosure herein includes wearable sensors (including any of those described herein) that are adapted to measure hormone levels and / or deliver agents with the wearable sensor. For example, any of the flexible patches herein may be adapted to measure hormones such as Cortisol. The presence of cortisol causes a measurable change in the electrical signals measured with electrodes (e.g., resistance, capacitance), which can be measured as an indicator of stress and / or glucose (for example).

[0128] Additionally, the patches herein may additionally or alternatively be configured to deliver one or more agents (e.g., therapeutics) to the body of the wearer. For example only, the patches herein may be coated with one or more hormones that are adapted to be released from the patch and pass through the skin over time (e.g. slow release). One or more drugs that can be pass through the skin may be coated and / or impregnated into the material of the wearable sensor for release and delivery to the subject.

[0129] Any of the electrodes herein may comprise adhesive to adhere to the skin when worn. Any of the wearable sensors herein may thus include one or more adhesive electrodes.

[0130] Any of the wearable sensors herein may be further adapted to sense electrical activity of the heart, which may be used to measure one or more features related to EKG.

[0131] Any of the wearable sensors herein may be configured to perform electrochemical analysis of perspiration (sweat) of the subject. In one implementation, the wearable can be adapted for iontophoresis; driving a current through the skin and producing sweat; and performing electrochemical analysis on the produced perspiration.

[0132] Any of the wearable sensors herein may also optionally be adapted to harvest energy from the body of the wearer. For example only, wearable sensors herein may be adapted to harvest energy and convert it to electricity to power the device, such as being thermoelectric using the body heat (see https: / / www.nature.com / articles / s41378-023-00583-3, fully incorporated by reference herein for all purposes), or harvesting kinetic energy (movement). For example only, wearable sensors may be configured to take advantage of higher skin temperature near one or more of an occipital artery, a posterior auricular artery, or a superficial temporal artery to generate electrical energy to power the device using the body heat. Generating power from the body can help reduce battery size, and thus the overall size / profile of the wearable sensor.

[0133] In some implementations, wearable sensors can be adapted such that the heat transfer pathway is through the electrodes and an adhesive layer (if there is an adhesive). Since adhesive patches are most preferably not electrically conductive (unlike the electrodes) an adhesive patch may be made of one or more materials that allow for heat transfer but have poor electrical conductivity. For example only, carbon materials such as diamond may be used but other materials may be used with similar properties. In some implementations, an adhesive layer is doped with thermoelectric harvesting materials.

[0134] Any of the wearable sensors herein may include one or more other types of sensors adapted to sense or measure one or more other biosignals. For example, any of the wearable sensors herein may also include one or more temperature sensors, a microphone to sense the voice of the wearer (e.g., to detect a diabetic voice versus a non-diabetic voice); opticalemitters and optical sensors (e.g. to measure HRV and / or HR); one or more inertial sensors (accelerometer / gyroscope / magnetometer). Any of the wearable sensors herein may be adapted to sense one or more biosignals that can be used to measure skin temp, heart rate (HR), heart rate variability (HRV), movement, blood pressure, peripheral oxygen saturation (spO2), gastric motility (EGG with abdomen sensor), and / or galvanic skin response (stress measurement).

[0135] For example only, the wearable sensors herein may include an optical sensor and may be adapted for Photoplethysmography (“PPG”), which generally includes emitting low intensity infrared light and detecting reflected light. A PPG sensor may be incorporated into any of the wearable sensors herein and may be disposed and positioned to be able to sense light reflected back from the body of the wearer. The electrical output of the optical sensor can be communicated to any of the wearable device components for storage, processing and / or communication to an external device (e.g., to an App on a smartphone). Alternative optical sensors may also be incorporated into the wearable devices herein. Any of the PPG sensors herein may optionally be used to measure blood pressure as well.

[0136] Any of the electronics packages herein may include a wireless module / chip (e.g. Bluetooth module) that facilitates wireless communication with a personal device, including both hardware (e.g., radio transceiver, processing unit, antenna) and software (e.g., Bluetooth protocol stack, controller). Wearable sensors herein may or may not have storage capabilities (e.g., memory). Wearables herein may or may not have signal processing / analyzing capabilities. Any of the wearables may include a micro-needle array, which may be adapted to sense ISF (similar to CGMs). A needle array can be positioned such that the needles extend into the skin. The wearables herein may be configured to have one or two-way communication with a user device (e.g., smartphone or watch), including an App that is stored on the user device. In some examples, the wearable is optionally adapted to continuously sense brain activity signals from the subject, for at least some continuous period or epoch of time, and continuously communicate (for at least some continuous period or epoch of time) in real or substantially real-time the raw or processed brain activity signals or information indicative thereof to an App on a user device, which is described elsewhere herein.

[0137] One aspect of this disclosure is related to wearable sensors that are adapted to sense or measure biosignals, and in some particular embodiments they are adapted to sense brain activity signals. The methods of use disclosed in WO / 2024 / 182777A2 and U.S. Pub. US20240293066 are fully incorporated by reference herein into this disclosure. For example,sensing brain activity signals may be used to provide one or more indicators of metabolic health of the wearer.

[0138] Even if not specifically indicated, one or more methods or techniques described in this disclosure (e.g. any of the computer executable methods) may be implemented, at least in part, in hardware, software, firmware or any combination thereof. For example, various aspects of the techniques or components may be implemented within one or more processors, including one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), programmable logic circuitry, or the like, either alone or in any suitable combination. The term “processor” or “processing circuitry” may generally refer to any of the foregoing circuitry, alone or in combination with other circuitry, or any other equivalent circuitry.

[0051] Such hardware, software, or firmware may be implemented within one device or within separate devices to support the various operations and functions described in this disclosure. In addition, any of the described units, modules or components may be implemented together or separately as discrete but interoperable logic devices. Depiction of different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be realized by separate hardware or software components. Rather, functionality associated with one or more modules or units may be performed by separate hardware or software components, or integrated within common or separate hardware or software components.

[0052] When implemented in software, the functionality ascribed to the systems, devices and techniques described in this disclosure may be embodied as instructions on a computer- readable medium such as random access memory (RAM), read only memory (ROM), nonvolatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), Flash memory, and the like. The instructions may be executed by a processor to support one or more aspects of the functionality described in this disclosure.

[0053] Any of the features from any of the examples or embodiments herein may be combined with any other feature unless it is expressly stated otherwise herein. For example, any of the methods herein may or may not be performed by a system or device.

Claims

CLAIMSWhat is claimed:

1. A wearable sensor adapted to sense at least electrical biosignals from a subject, comprising a plurality of electrodes; a flexible patch for placement on a subject; and an electronics package, the flexible patch and the electronics package each configured to be coupled for use and uncoupled from the other, wherein the wearable sensor is adapted to sense electrical biosignals from a subject with the plurality of electrodes when worn by the subject.

2. The wearable sensor of Claim 1, wherein the flexible patch includes the plurality of electrodes.

3. The wearable sensor of Claim 2, wherein the electronics package comprises a plurality of conductive pins, each positioned to electrically interface with one of the plurality of electrodes when the flexible patch and the electronics package are coupled to create electrical communication between the plurality of electrodes, the conductive pins, and electronics within the electronics package.

4. The wearable sensor of Claim 1, wherein the electronics package comprises the plurality of electrodes, the flexible patch including a plurality of apertures each sized to receive therethrough one of the plurality of electrodes to cause the plurality of electrodes to be exposed on a skin-facing surface of the flexible patch to make contact with the skin of the subject when worn.

5. The wearable sensor of Claim 4, wherein the plurality of electrodes are attached and integrated as part of the electronics package.

6. The wearable sensor of Claim 4, wherein each of the plurality of electrodes include a removable communication interface, each of the removable communication interfaces configured to fit over a pin of the electronics package to be secured to the electronics package, and to be removed from the pin and the electronics package.

7. The wearable sensor of Claim 6, wherein the removable communication interfaces are conductive and conductively coupled with the pins8. The wearable sensor of Claim 6, wherein the removable communication interfaces are capacitive coupled with the pins.

9. The wearable sensor of Claim 6, wherein the removable communication interfaces are ionically coupled with the pins.

10. The wearable sensor of Claim 4, wherein each of the plurality of electrodes comprises a conductive polymeric material.

11. The wearable sensor of Claim 4, wherein the electronics package further comprises an ear-facing surface that is non-planar with the skin-facing surface, and wherein at least two of the plurality of electrodes are associated with the skin-facing surface and at least one of the plurality of electrodes is associated with the ear-facing surface.

12. The wearable sensor of claim 11, wherein the ear-facing surface is concave and the at least one of the plurality of electrodes that is associated with the ear-facing surface has a concave ear-facing surface.

13. The wearable sensor of claim 4, wherein each of the plurality of electrodes extends proud relative to an electronics package surface with which the corresponding electrode is associated.

14. The wearable sensor of claim 4, wherein one or more of the plurality of electrodes is flush with an electronics package surface with which the corresponding electrode is associated.

15. The wearable sensor of claim 4, wherein more than one of the plurality of electrodes has a rounded skin-facing surface.

16. The wearable sensor of claim 1, wherein the flexible patch comprises one or more interfacing surfaces positioned, sized and adapted to interface with one or more surfaces of the electronics package to at least one of stabilize the electronics package relative to theflexible patch or create a water resistant seal between the electronics package and the flexible patch.

17. The wearable sensor of claim 16, wherein the one or more interfacing surfaces comprise a gasket.

18. The wearable sensor of claim 16, wherein the one or more interfacing surfaces comprises an outer portion of the flexible patch with one or more materials adapted to be compressed and create a seal as the electronics package is coupled to the flexible patch.

19. The wearable sensor of claim 18, wherein the outer portion has a durometer that is higher than a durometer of an adjacent flexible housing portion.

20. The wearable sensor of claim 16, wherein the one or more interfacing surfaces form a protruding collar in an outer portion of the flexible patch.

21. The wearable sensor of claim 16, wherein the one or more interfacing surface comprise one or more magnetic materials adapted to facilitate magnetic coupling between the flexible patch and the electronics package as the electronics package is moved toward the flexible patch.

22. The wearable sensor of claim 21, further comprising a portion that is adapted to be compressed to create a seal as the electronics package is coupled to the flexible patch.

23. The wearable sensor of claim 1, further comprising coupling means to at least one of stabilize the electronics package relative to the flexible patch or create a water resistant seal between the electronics package and the flexible patch.

24. The wearable sensor of claim 1, wherein the flexible patch includes an adhesive material on at least a portion of a skin-facing surface of the flexible patch.

25. The wearable sensor of claim 24 further comprising a removable cover disposed on the adhesive, the removable cover layer adapted to be removed to expose the adhesive and allow the flexible patch to be adhered to the subject.

26. The wearable sensor of claim 25, wherein the removable cover includes first and second projections extending beyond an outer edge of the flexible patch, the projection sized to be grasped to facilitate removal of the removable cover.

27. The wearable sensor of claim 26, wherein the projections extends from first and second opposing sides of the wearable sensor.

28. The wearable sensor of claim 27, wherein the opposing sides are side along a length of the wearable sensor, the length greater than a width of the wearable sensor.

29. The wearable sensor of claim 26, wherein the cover further comprises first and second buckled sections each adjacent one of the first and second projections.

30. The wearable sensor of claim 26, wherein the cover further comprises a separation region adapted to more easily separate than adjacent regions of the cover.

31. The wearable sensor of claim 30, wherein the separation region includes elongated perforated sections.

32. The wearable sensor of claim 25, wherein the removable cover does not cover the plurality of electrodes.

33. The wearable sensor of claim 32, wherein the plurality of electrodes protrude from a skin-facing surface of the wearable sensor.

34. The wearable sensor of claim 1, wherein the electronics package includes the plurality of electrodes, a first electrode of which is exposed on a skin-facing surface of the electronics package, and a second electrode of which is exposed on an ear-facing surface of the electronics package, the skin-facing surface and the ear-facing surface in a non-planar relationship and the first and second electrodes having skin facing surfaces that are in a non- planar relationship.

35. The wearable sensor of claim 1, wherein a first of the plurality of electrodes is an ear electrode that is positioned to be in contact with a posterior surface of an ear when the wearable sensor is placed behind an ear on a scalp.

36. The wearable sensor of claim 35, wherein wearable sensor is configured such that the ear electrode is a ground electrode.

37. A flexible patch for use with a wearable sensor that is adapted to sense at least electrical biosignals from a subject, the flexible patch comprising: a flexible patch body sized and configured for placement on a subject’s head, the flexible patch body including one or more interfacing surfaces positioned, sized and adapted to interface with one or more surfaces of an electronics package to at least one of stabilize the electronics package relative to the flexible patch or create a water resistant seal between the electronics package and the flexible patch.

38. The flexible patch of claim 37, further comprising a plurality of electrodes.

39. The flexible patch of claim 37, wherein the plurality of electrodes are integrated and monolithic with the flexible patch body.

40. The flexible patch of claim 39, wherein each of the plurality of electrodes comprises a conductive polymeric material.

41. The flexible patch of claim 38, wherein each of the plurality of electrodes comprises an internal channel therein.

42. The flexible patch of claim 38, wherein each of the plurality of electrodes has an annular conductive region.

43. The flexible patch of claim 42, wherein the flexible patch is transparent within the annular conductive region.

44. The flexible patch of claim 37, further comprising an adhesive layer.

45. The flexible patch of claim 44, further comprising a removable cover that includes at least one projection extending beyond an edge of the flexible patch.

46. The flexible patch of claim 37, further comprising a plurality of apertures sized to receive a plurality of electrodes of an electronics package.

47. The flexible patch of claim 37, wherein the one or more interfacing surfaces comprise a gasket.

48. The flexible patch of claim 37, wherein the one or more interfacing surfaces comprise an outer portion of the flexible patch with one or more materials adapted to be compressed and create a seal as an electronics package is coupled to the flexible patch.

49. The flexible patch of claim 48, wherein the outer portion has a durometer that is higher than a durometer of an adjacent flexible body portion.

50. The flexible patch of claim 37, wherein the one or more interfacing surfaces form a collar in an outer portion of the flexible patch.

51. The flexible patch of claim 37, wherein the one or more interfacing surfaces comprise one or more magnetic materials adapted to facilitate magnetic coupling between the flexible patch and an electronics package as an electronics package is moved toward the flexible patch.

52. An electronics package for use with a wearable sensor that is adapted to sense at least electrical biosignals from a subject, the electronics package comprising any of the features or aspects in any of claims 1-36 or described herein.

53. A method of manufacturing a flexible patch for use as part of a wearable sensor, the method comprising: molding a flexible patch body that comprise a first material with a second material, the second material (optionally silicone) forming a gasket disposed at least partially around an outer edge of the first material, wherein the molding process bonds the first material to the second material and forms the patch body.

54. A method of manufacturing a flexible patch for use as part of a wearable sensor, the method comprising:molding a flexible patch body that comprise a first section with a second section, the second region (optionally comprising silicone) forming a gasket disposed at least partially around an outer edge of the first section, wherein the molding process bonds the first section to the second section.

55. A method of manufacturing a flexible patch for use as part of a wearable sensor, the method comprising: molding a flexible patch body that comprise a first section with a second section, the second region (optionally comprising silicone) forming a collar disposed at least partially around an outer edge of the first section, wherein the molding process bonds the first section to the second section.

56. A method of manufacturing an electronics package for use as part of a wearable sensor, the method comprising: assembling electronics that will be internal to the electronics package; coupling a plurality of pins to the electronics; placing the assembled electronics and coupled pins in a mold such that the pins elevate the electronics away from a surface of the mold; positioning material into the mold such that the material embeds the assembled electronics; causing the material to form an electronics package body; and removing the electronics package body from the mold.

57. A method of manufacturing an electronics package for use as part of a wearable sensor, the method comprising: assembling electronics that will be internal to the electronics package; placing the assembled electronics in a mold such that the electronics are away from surfaces of the mold; positioning material into the mold such that the material embeds the assembled electronics, wherein the material comprises a first material for a body of the electronics package and a second material for a plurality of electrodes; causing the material to form a monolithic electronics package body with integrated electrodes; and removing the electronics package body from the mold.

58. A method of determining a preferred wearable sensor location for wearing on a subject.

59. The method of claim 58, wherein the method comprises any one or more steps described herein related to determining a preferred sensor placement on a user.

60. The method of claim 58 or claim 59, further comprising, positioning a plurality of electrodes of the wearable sensor against the user; analyzing the electrical impedance of the wearable sensor over a range of frequencies; and determining a preferred location of the wearable sensor on the skin.

61. The method of claim 60, further creating an output indicating a preferred location versus a non-preferred location.

62. The method of claim 61, wherein the output is one of audible, visual, or vibratory.

63. The method of any of claims 58-62, wherein a cover is not removed prior to determining the preferred location.

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