Created cavity biometric sensor

Abstract

Devices, systems, and related methods are disclosed for wearable devices for sensing various anatomical conditions and / or metrics of a wearer, including measuring the data and optionally transmitting the data to a computing device that analyzes the data to determine various physiological conditions inside and / or near the body of the wearer. The device includes a central body having a first sensor and a body puncture post having a second sensor, wherein the sensors measure a first physiological condition and a second physiological condition of a wearer, respectively, continuously or periodically using specific time intervals.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the U.S. Provisional Patent Application No. 63 / 389,891, filed on July 17, 2022, entitled “CREATED CAVITY BIOMETRIC SENSOR,” the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present invention relates to wearable devices and associated system components that sense, measure, transmit and present various data, including data regarding physiological conditions within and / or near the body of a wearer, including vital signs, biological data and temperature within an artificially created cavity within the wearer's body (created cavity temperature or "CCT"). Background Art

[0004] The quantified self is a movement that ideally combines technology, communication, measurement, quantification, and / or data assessment (including self-tracking data) to improve the physical, mental, and emotional health of an individual or group, as well as to gain insights into an individual's health and daily functioning through the use of self-tracking data. As the quantified self movement becomes more prevalent, consumers are increasingly seeking to leverage technology to capture additional data about various aspects of an individual's daily life, including inputs (e.g., food consumed, ambient air quality), status (e.g., blood oxygen levels, body temperature), and / or performance. This self-monitoring concept combines environmental and / or wearable sensors with computing devices to produce outputs that ideally improve daily functioning and allow users to more accurately track and optimize their health.

[0005] Increased consumer interest in personal health has resulted in a wide variety of personal health monitoring devices being offered on the market. For example, wearable electronic devices for monitoring personal health are well known in the art and include electronic measuring devices that can be worn on a finger, wrist, or any other body part. Typically, such devices include electronic components, such as flexible printed circuit boards, processors, sensors, batteries, etc., which are worn close to and / or on the surface of the skin. They detect, analyze, and transmit information about body signals such as vital signs and / or environmental data on the skin, and in some cases allow biofeedback to be provided immediately to the wearer. Also commonly referred to as wearable devices, fashion technology, smart clothing, tech clothing, streetwear technology, skin electronics, or fashion electronics, wearable devices such as activity trackers are examples of the Internet of Things because "things" such as electronics, software, sensors, and connectivity are effectors that enable objects to exchange data with manufacturers, operators, and / or other connected devices over the Internet without human intervention. Wearable devices are popular among electronics consumers, most commonly in the form of smart watches, smart rings, and implants, including FitBit monitors (available from FitBit, San Francisco, California, U.S.), Apple watches (available from Apple, Inc., Cupertino, California, U.S.), Samsung gear Fit2 wristbands (available from Samsung Electronics Co. Ltd., Suwon, South Korea), and Oura rings (available from Oura Health Ltd., Olo, Finland). Most wearable devices measure various physical conditions on a person's skin (i.e., temperature, heart rate variability, blood oxygen levels, pulse rate, respiration rate, etc.) and often perform other functions. Summary of the invention

[0006] At least one aspect of the present invention includes fulfilling the need in the art to develop a wearable device for measuring a number of physiological conditions of the wearer on a daily and / or nightly basis, including but not limited to one or more of body temperature, resting heart rate, heart rate during activity, heart rate variability, oxygen sensing, blood oxygen level, resting pulse rate, aortic pulse rate, respiratory rate, movement, sleep, blood glucose level, blood pressure and / or SpO2 sensing. In addition, there is a need to accurately and usefully monitor an individual's body temperature during daily activities or sleep, including changes in such temperature. In addition, it is desirable to have a physiological condition monitoring device that provides continuous monitoring through a convenient home device. Such a device may represent an improvement in advancing the quantified self movement by providing a controllable self-tracking method to determine various health issues and / or related conditions, such as fever, stress, seizures, physical activity levels, sleep and sleep patterns, women's health, menstrual health, general health, infection, viral exposure, pregnancy, perimenopause, menopause, infertility and / or fertility. Furthermore, the disclosed devices and associated systems may greatly benefit the field of public health by identifying health issues at an early stage, potentially reducing healthcare costs by eliminating undiagnosed or unaddressed health issues, women's health conditions, menstrual health conditions, the need for excessive doctor visits, and / or providing an alternative to chemical-based testing procedures such as fertility testing.

[0007] In one specific embodiment, the present invention provides a device for measuring useful body temperature, resting heart rate, heart rate during activity, heart rate variability, oxygen sensing, blood oxygen level, resting pulse rate, activity pulse rate, respiratory rate, exercise, sleep and / or SpO2 sensing via an artificially created cavity in the human body, meaning that the cavity in the body of the device wearer is generally not the result of natural anatomy. In the human body, there is a wide range of potential sites that can be used for temperature measurement, including the surface of the skin, the armpits or armpits, and / or the groin, as well as within existing body cavities such as the mouth, ears, nasal passages, esophagus, rectum, pulmonary arteries, urethra, or bladder. Superficial sites (skin, armpits, groin) are most commonly used to detect patient body temperature due to their accessibility, but the measurement accuracy of such sites is often affected by various variables, including sweating, ambient air circulation, humidity, blanket use, and / or peripheral vasoconstriction. Deep body parts (esophagus, bladder, rectum) generally reflect core body temperature more accurately, but access and continuous monitoring of deep body parts is much more cumbersome to use and set up, and such monitoring significantly limits the wearer's activities and daily activities. Although existing natural body cavities and / or openings can provide temperature measurements for a variety of purposes, naturally occurring body cavities are used for many other daily activities (i.e., eating, breathing, speaking, hearing), and measuring instruments typically placed in such cavities prevent or severely interfere with these other daily activities during measurement. In addition, the placement and / or presence of monitoring equipment in naturally occurring body cavities is generally neither comfortable nor aesthetically pleasing to the wearer for a long period of time. However, the creation of artificial cavities provides repeatable and / or continuous access to various tissues and / or tissue regions / planes located below the skin surface, including subcutaneous and / or subdermal anatomical regions with temperatures that more accurately reflect the wearer's core body temperature, and placing measuring equipment in artificial cavities is expected to not significantly interfere with the wearer's mobility and / or daily activities.

[0008] In various embodiments, the device may determine a sensed cavity temperature or a created cavity temperature (CCT). Depending on the location of the artificial cavity and the patient's unique anatomy, the CCT may be highly reflective of one or more of the core body temperature (CBT), basal body temperature (BBT), internal body temperature (IBT), and / or surface body temperature (SBT), although the temperature inside the created cavity does not necessarily need to be related to the CBT, BBT, IBT, and / or SBT based on the relationship. In a non-limiting example, the cavity may be a pierced ear cavity in the human earlobe (ear lobule). The human earlobe is the soft, fleshy part of the outer ear and receives a large blood supply from the posterior auricular branch of the external carotid artery, which is highly reflective of the internal body temperature. The disclosed device may be similar in size, shape, and / or weight to a pearl stud earring (or other decorative type of fashion and / or functional earring), which may be worn during sleep to monitor a woman's fertility trends, wherein the created cavity is the result of an ear piercing process that occurred many years before the currently disclosed device was obtained. In this example, the device is inserted into the created cavity through the two holes (entrance and exit) initially formed by the piercing process. In another non-limiting example, the device can be similar to a belly button stud and / or ring, a nose stud / ring, an eyebrow stud / ring, a lip stud / ring piercing, a tongue stud / ring piercing, a genital stud / ring piercing, or any other piercing on the body.

[0009] In various embodiments, the device may include at least one wearable sensor and / or biosensor or temperature sensor, which may be positioned, for example but not limited to, within and / or through the created cavity. The sensor may be operated periodically or continuously at specific time intervals, wherein the device periodically or continuously reads the temperature. A variety of temperature or other indicator sensing devices are contemplated herein, including thermocouples, resistance temperature detectors (RTDs), thermistors (including negative temperature coefficient thermistors or NTCs), semiconductor-based integrated circuits, semiconductor sensors, silicon diodes, infrared sensors, bimetallic devices, thermometers, and / or state change sensors.

[0010] According to at least one exemplary embodiment, the post of the device is sized and configured to substantially or completely occupy the created cavity and substantially close any gap between the cavity opening through which the device is inserted. If desired, the earring base and corresponding closure device can be placed against the opposing ear surface to help maintain a stable temperature measurement within the created cavity.

[0011] Various embodiments disclosed herein desirably utilize an artificially created physiological cavity, such as a puncture cavity extending between two adjacent skin surfaces of the human body. Within the artificial cavity, the device may include sensors or other devices that measure CCT and / or other physical conditions, with the CCT ideally corresponding in some way to the core body temperature or other desired temperature of the wearer. First, the created cavity does not naturally exist in the human body, but the created cavity is "added" to the wearer's body for a variety of different reasons. Of course, depending on the device design and the wearer's natural anatomy, it is conceivable that the device can accommodate some of the wearer's natural cavities or orifices.

[0012] In various embodiments, the devices disclosed herein can accurately measure the temperature within the wearer's artificially created physiological cavity as well as the external environmental temperature, such as ambient air temperature and / or water temperature (during swimming, hot tubs, bathing, etc.), which temperature readings can be periodically and / or continuously recorded and / or transmitted to a computing device such as a cell phone or computer. Providing external temperature measurements simultaneously with sensed physiological temperature measurements can significantly improve the accuracy and reliability of the present system, as external temperature fluctuations can often affect various patient temperature measurements.

[0013] Similarly, some embodiments of the disclosed device may include various additional components and / or sensors located within, inside, adjacent to, or in close proximity to the wearer's artificially created cavity to detect other wearer activities, such as accelerometers that can measure wearer motion and / or wearer activity levels, GPS sensors, LED sensors, pressure sensors, etc. Such additional measurement capabilities will hopefully further improve the accuracy and / or reliability of the system by incorporating data that may reflect wearer events or matters that may affect the accuracy and / or reliability of the sensed internal temperature measurements, including providing the system with the ability to detect, analyze, highlight, and / or ignore various data points or trends that the system may detect, including anomalous and / or unexpected readings, particularly where an artificial intelligence (AI) system may be used to analyze the wearer data generated thereby.

[0014] In various embodiments, the wearable device may further include a miniaturized transmitter / receiver with optional wireless communication components. To power these components, one or more batteries may be integrated into the wearable device, and small low-power rechargeable battery components may be used to provide power for various parts of the system.

[0015] It is expected that the system will be small, compact, and lightweight in design, for example by using various combinations of rigid and / or soft or flexible materials in the design, thereby increasing comfort and ease of wearing at home during sleep and daily activities.

[0016] It is contemplated that in operation, the system is used to measure CCT and / or other anatomical information, which information can be used to track and / or derive medically useful information and determine fertility, menstrual cycle health, blood pressure, heart health, respiratory and lung health, fever, illness, acute pain, chronic disease or constant temperature and vital signs and biodata monitoring systems for hospital use. A variety of uses and environments for the disclosed system components are contemplated herein, including use of the device for: fertility, infertility, natural family planning, COVID, infectious diseases, cancer, long-term hospital care, fever, thyroid issues, gynecological health, pregnancy, material health conditions, gut health, diabetes, obesity, asthma, PMS, PCOS, endometriosis, perimenopause, menopause, osteoporosis, menstrual disorders, urinary tract infections, heart disease, eclampsia, COPD, women's health, health management, stress, sleep, diet / calorie counting, activity / fitness, sports, government health, military, agriculture, etc. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] A complete and enabling disclosure, including the best mode thereof, for those skilled in the art is more particularly set forth in the remainder of this specification (including reference to the accompanying drawings). The accompanying drawings illustrate certain aspects of the present invention and together with the description are used to explain but not limit the principles of the present invention. The same reference numerals used therein represent the same components in several drawings.

[0018] Figure 1 An exploded perspective view depicting one exemplary embodiment of a wearable sensing device in the form and shape of a post earring;

[0019] Figure 2 Depiction Figure 1 Assembled wearable sensing devices;

[0020] FIG. 3A to FIG. 3F Depiction Figure 1 Various views of the flexible board and battery of a wearable sensing device;

[0021] Figure 4 Depiction Figure 3A and 3B An exemplary layer cross section of a flexible sheet;

[0022] Figure 5A Depiction Figure 3A and 3B a first surface of a flexible board and a component layout;

[0023] Figure 5B Depiction Figure 3A and 3B A second surface of the flexible board and a component layout;

[0024] FIG. 6A to FIG. 6E Draw from top to bottom Figure 3A and 3B The pinhole locations within each layer of the flexible board;

[0025] 7A to 7F Draw from top to bottom Figure 3A and 3B An exemplary mask layer in a flexible board;

[0026] FIG. 8A to FIG. 8C Depiction Figure 1 An exemplary circuit diagram of a wearable sensing device;

[0027] Fig. 9 Describe the Figure 1 A sensor within a spike assembly of a wearable sensing device;

[0028] FIG. 10A to FIG. 10C Depiction Figure 1 Various views of an exemplary embodiment of a charging and storage case for a wearable sensing device;

[0029] Fig. 10D and 10E depicting a view of an alternative embodiment of a charging and storage case for an earring device;

[0030] FIG. 11A to FIG. 11D Various graphical user interface displays (GUIs) depicting exemplary embodiments of an application or APP loaded on a mobile phone;

[0031] Fig.12 An exemplary flow chart showing application program application to data processing of CCT measurements or values;

[0032] Fig.13 An exemplary use of time-dependent temperature measurements for determining fertility is graphically illustrated;

[0033] Fig.14 is an alternative embodiment of a wearable sensor device that can be used as a closure, backing, or similar attachment device for multiple earrings;

[0034] Fig.15A Depicted in use Fig.14 The wearable sensor device fastens to a series of existing earrings;

[0035] Fig. 15B Depicting the advancement of wearable sensor devices on earring posts, and

[0036] Fig. 15C Depicts a wearable sensor device secured to an earring post, wherein the sensing device is positioned within a pierced cavity of a human ear. DETAILED DESCRIPTION

[0037] Reference will now be made in detail to various embodiments of the subject matter of the present disclosure, one or more examples of which are set forth below. Each embodiment is provided by way of explanation rather than limitation of the subject matter. In fact, it will be apparent to those skilled in the art that various modifications and variations may be made to the present disclosure without departing from the scope or spirit of the present disclosure. For example, a feature shown or described as a part of one embodiment may be used in another embodiment to produce yet another embodiment. Therefore, the present disclosure is intended to cover such modifications and variations within the scope of the appended claims and their equivalents.

[0038] Ranges can be expressed as from "about" one particular value and / or to "about" another particular value. When such ranges are expressed, another aspect includes from a particular value and / or to another particular value. Similarly, when values ​​are expressed as approximations, by using the antecedent "about," it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each range in the range are significant relative to and independent of the other endpoint.

[0039] As used herein, the terms "optional" or "optionally" mean that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not.

[0040] The present disclosure also incorporates the disclosure of U.S. Patent No. 10,117,643, entitled “Created Cavity Temperature Sensor”, filed on April 25, 2015, which is hereby expressly incorporated herein by reference. The components disclosed herein may be used in systems and / or methods for monitoring characteristics of humans and other animals, including those inventions and concepts disclosed and described in U.S. Patent No. 10,117,643 to Gevaer T et al.

[0041] The present disclosure generally relates to a device for measuring various physiological conditions of a wearer. Such measurements may include sensing useful body temperature and / or its changes over time, heart rate, respiratory rate, blood oxygen, pulse, motion, activity, calories, distance traveled, number of steps, blood pressure, glucose monitoring, angular velocity measurement, location (e.g., global positioning), magnetic field measurement, and ambient noise and other conditions.

[0042] More specifically, the device is capable of, among other things, measuring a created cavity temperature (CCT) within an artificially created cavity in a living tissue or wearer's body into which the device is inserted. The current device provides a wearable thermometer that measures temperature continuously or periodically, continuously tracking the wearer's temperature in a convenient and comfortable manner. Alternatively or in combination, the device may include an LED sensor for heart rate, respiratory rate, blood oxygen and / or pulse measurement. Alternatively or in combination, the device may include an accelerometer for motion, activity, calories, distance traveled and / or steps. Alternatively or in combination, the device may include an LED sensor and / or a pressure sensor for blood pressure. Alternatively or in combination, the device may include a CGM sensor for glucose monitoring. Alternatively or in combination, the device may include a gyroscope for angular velocity measurement. Alternatively or in combination, the device may include a global positioning system sensor. Alternatively or in combination, the device may include a magnetometer for magnetic measurement. Alternatively or in combination, the device may include a microphone and / or speaker for ambient environment monitoring, or for listening to music, responding to phone calls, etc.

[0043] Create body cavity

[0044] It should be understood that the disclosed devices may be used at various locations on / in the human body, although for many people, body piercing locations such as one or both earlobes may be particularly preferred (and such locations may already be pierced to receive various decorations). The various piercing locations may be suitable for biometric measurements and temperature sensing, resting heart rate, heart rate during activity, heart rate variability, heartbeat sensing, oxygen sensing, blood oxygen levels, blood pressure, resting pulse rate, activity pulse rate, perfusion, respiratory rate, exercise, sleep, SpO2 and / or glucose, bacteria measurements, white blood cell counts, proteins, lipids, salts, fats (or other fluid characteristics, including lymphatic or other fluid characteristics), and various other data, including location (via GPS), sound sensors, accelerometer data, etc. In some cases, local body conditions near specific piercing locations may be particularly suitable for measuring various physiological conditions, such as tongue piercings for tracking glucose measurements and / or blood sugar levels.

[0045] The disclosed CCT is a measurement that can be obtained from an artificially created cavity in the body of a wearer, where, as a non-limiting example, the created cavity is an artificially formed earring piercing process. In addition, two or more artificially created cavities can be used to measure CCT within one body. As a non-limiting example, two different biosensing devices or wearable sensing devices can be used in two different created cavities to simultaneously measure two CCT values ​​(or other anatomical indicators) within the separately created cavities. In addition, these different sensing devices can be used to derive a single CCT (or other anatomical indicator). It should be understood that the CCT (or other anatomical indicator) from one created cavity in the body of a wearer may be different from the CCT (or other anatomical indicator) obtained from another created cavity in the body of the same wearer, because anatomical differences may result in localized temperature changes (e.g., the CCT or other indicator of an ear piercing may be different from the CCT or other indicator of a navel or tongue piercing of the same wearer, or the CCT or other indicator of opposing ear piercings may be different due to various environmental and / or anatomical reasons).

[0046] The disclosed device may ideally measure CCT or other indicators within the created cavity to track the useful temperature of the wearer or for other purposes. Aspects of the created cavity are further described below. CCT may be the same or different from temperature measurements of core body temperature (CBT), internal body temperature (IBT), basal body temperature (BBT), body cavity temperature (BCT), and / or surface body temperature (SBT). This can be recognized by the following reasons: the temperature within the created cavity does not need to be equal to and / or related to the CBT, IBT, BBT, BCT, and / or SBT based on a relationship. In addition, it is appropriate if the CCT measurement perfectly matches, is higher, lower, or is not a 1:1 relationship with body temperature.

[0047] The disclosed device may provide a practical design that provides a means for a comfortable, convenient, and unobtrusive method for continuously or periodically tracking the wearer's body temperature or other biometrics while sleeping, resting, or active. For example, but not limited to, the device may be shaped like a small stud structure that may be worn on the body via the wearer's earlobe, the wearer's navel, tongue, nose, brow, lip, genitals, and / or other body locations. The device allows for wireless communication with an external system to track continuous or periodic measurements, which may be used for the non-limiting example of determining fertility by identifying changes in body temperature associated with the biological event of ovulation.

[0048] With the disclosed device, cavity temperature measurements and / or other measurements may be obtained from a wearer over a defined time period. In a non-limiting example, cavity temperature measurements may help assist in the determination of fertility. In this example, readings are evaluated to distinguish local minima during a given night's sleep, where a local minimum is defined by the lowest reading within a pre-established time period. The local minima may then be plotted against the timing of fertility trends. Additionally, measurements may be tracked over a 24-hour period and temperatures from different days and nights compared to determine patterns, as a non-limiting example, to identify or predict the wearer's ovulation date.

[0049] Ovulation and fertility testing

[0050] According to the Centers for Disease Control and Prevention (CDC), 12.3% of U.S. women aged 15-44 (7.5 million people) have an impaired ability to become pregnant or maintain a pregnancy. Ovulatory defects are present in 40% of these women, but are difficult to characterize because ovulation is an internal, often unmonitored clinical state that evolves rapidly over a short period of time. Identifying the rapidly changing ovulatory physiology of each affected woman requires frequent monitoring during suspected ovulatory windows. Furthermore, although the rhythm method of birth control (e.g., tracking the menstrual cycle on a calendar to predict ovulation) is more than 75% effective in preventing unintended pregnancy, less than 1% of women aged 15 to 44 currently use this highly effective form of natural birth control.

[0051] The need for frequent monitoring currently translates into a significant patient burden when predicting ovulation to achieve both pregnancy and birth control goals. The use of basal body temperature (BBT) recording is a known and safe method of monitoring ovulation and has the advantage of patient self-monitoring at home (no clinic appointments or visits required) at minimal cost and risk compared to blood tests or ultrasounds. However, the use of the BBT method is hampered by the inconvenience of measuring and recording waking body temperature at the same time every morning - patient compliance is particularly poor. Even for those who comply, the information is difficult to interpret and is often frustrating for patients.

[0052] Conventional fertility thermometers measure a woman's basal body temperature (BBT) through a natural body cavity, helping to track a woman's ovulation trends. These devices do not provide the most accurate ovulation results due to the inconvenient thermometer required to take the temperature upon waking. In contrast, the disclosed device and associated system components would ideally eliminate any need to wake up before taking a temperature measurement, and more accurately identify low temperatures within a given night's sleep, as low temperatures do not necessarily occur upon waking. This is ideally accomplished through a small wearable sensor, such as a temperature sensor located within an artificially created cavity within the body, which provides continuous or periodic CCT readings that are wirelessly transmitted and analyzed by the wearer's associated smart device.

[0053] In one exemplary embodiment, the disclosed earring technology and system utilizes an earring sensor (similar in visual appearance to the earrings that many American women wear daily) to conveniently monitor ovulation by measuring basal body temperature (BBT). Because the monitoring occurs at home, the inconvenience and cost to the patient is reduced, and care can be provided more equitably. In addition, the application of the device disclosed herein can extend far beyond the scope of infertility and can be extended to identifying ovulation / avoiding pregnancy in fertility management, assisting in health tracking, conducting infection / COVID monitoring and / or other uses, providing early pregnancy detection, assisting in natural birth control, identifying pregnancy, childbirth and menopausal onset, and / or recording the wearer's menstrual cycle and / or other health indicators. In various embodiments, the earring can include features that can alert the wearer (i.e., using sound, vibration, light and / or electrical pulses to the user) of important information, such as the proximity or non-approach of the device (i.e., phone anti-theft) or the receipt of an email, text message, information update or phone call, etc. The disclosed device and related system components also provide the ability to obtain information based on early detection of personal health problems or conditions (such as infection, COVID19, viruses, pregnancy, early childbirth, perimenopause, special conditions for women, or the need to take specific medications or vitamins). The device can also be used for other medical applications, as a non-limiting example, as seen in detecting fever and / or disease. In addition, the device can be used to derive medical tracking information and be used in hospitals where constant or regular temperature and vital and biometric monitoring are required. Additional applications contemplated herein include, but are not limited to, fertility, infertility, natural family planning, COVID infection and / or conditions, infectious disease symptoms and / or susceptibility, cancer diagnosis and treatment, long-term hospital patient monitoring, fever detection and treatment, thyroid problems, intestinal health, diabetes detection and management, obesity, asthma, heart disease, chronic obstructive pulmonary disease, women's health issues, health management, stress management, sleep monitoring and disease detection and treatment, diet and calorie counting, activity / fitness tracking, sports, government health, military, agriculture, etc.

[0054] Equipment design and dimensions

[0055] The present invention includes a plurality of separate components assembled into an earring or other piercing device, which in a non-limiting example may have an overall size of approximately 1 / 2 inch by 1 / 2 inch, preferably 3 / 4 inch by 1 / 4 inch, and most preferably 1 / 2 inch by 1 / 4 inch, although the present disclosure contemplates a variety of device sizes, shapes, weights, and / or designs. In general, the device will ideally be sized and / or shaped to comfortably fit into and / or through a created cavity, such as an ear piercing cavity (or other piercing cavity), while accommodating the surrounding anatomy of the wearer, such as the adjacent skin surface, earlobe, etc. Additionally, the weight of the device will ideally be minimized, where possible, to reduce stress and / or damage to the associated body part (such as the earlobe, etc.) in which it is positioned.

[0056] Figure 1 A simplified exploded perspective view of a body mounted sensing device depicting the form and shape of a post-type earring 100. The earring 100 includes a central body 110, a base 120, a post 130, a surface dome or cap 140, and a clasp or backing 150.

[0057] like FIG. 3A to FIG. 3D As best shown in FIG. 3 , the center body 300 may include a semi-flexible board, a flexible board, or a flexible circuit board 310 having a first rigid segment 320, a second rigid segment 330, and a flexible link 340 located therebetween and connecting the two rigid segments. The shapes of the two rigid segments are ideally circular to fit within the dome housing. Exemplary dimensions of the flexible board component may include a thickness of 825 μm (±120 μm) and a diameter of approximately 10 mm for each rigid segment, with a thickness of 133 μm (±50 μm) for a 6 mm long flexible segment with a width of 3.48 mm and a bend radius of 0.55 mm.

[0058] In the depicted embodiment, the power source or battery 350 may be positioned or sandwiched between the first and second rigid segments for sizing considerations and / or various other reasons, although a variety of component configurations and / or arrangements may be utilized by those of ordinary skill in the art of circuit design. In various embodiments, the disclosed device ideally utilizes minimal power and is capable of measuring the wearer's body temperature or other vital signs or biological data (and / or other measurements) via the earring post within the ear hole at least every 15 minutes for a minimum of eight (8) hours before requiring recharging. More preferably, the disclosed device allows for the ability to measure the wearer's temperature via the earring post within the ear hole every 15 seconds for a minimum of twenty-four (24) hours before requiring recharging. As described herein, a carrying and / or storage case for the earrings may include a battery charging feature integrated into the portable storage case.

[0059] Various types of batteries can be used for any of the components described herein, including thin film batteries, flexible batteries, rechargeable batteries, non-rechargeable batteries, electronic charging, solar charging, trickle charging, battery maintainers, etc.

[0060] Figure 3C and 3D Depicts the bending into the desired “stacked” configuration Figure 3A and 3B 310, wherein a battery 350 (e.g., a 3.7 volt 13m-A-hr lithium-ion battery commercially available from Shenzhen Grepow Battery Co., Ltd. of Shenzhen, China) is ideally located between rigid sections 320 and 330, with battery leads 360 shown extending along and / or connected to ports on the second rigid section 330. The first rigid section will ideally house the MCU, memory, and RF antenna, preferably thermally isolated to some extent from the second rigid section that generates more heat, and isolates digital signals from analog signals. The second rigid section will ideally house the power supply, analog sensors, column assembly, and battery (which can be soldered as a post-process to SMD placement). The battery leads are ideally soldered to the castellated edge connections of this section. The first rigid section may also contain castellated edge connections for a SWD debug / programming interface between the MCU and an external debugger / programmer.

[0061] In various embodiments, a micro transmitter is included on a flexible board and is used to connect wearable sensors, LED sensors, accelerometers and other sensors to a measurement tracking or control device. The transmitter can be located at one end of the device and is ideally located outside the artificially created cavity. The transmitter contains the ability to isolate, amplify, filter noise, linearize and convert input signals from data sensors and wearable sensors and send standardized output signals to a computing / control device. A common electrical output signal range is used.

[0062] like FIG. 3B to FIG. 3DAs best shown in FIG. 1 , the central post 370 desirably extends through and is secured within the opening in the second rigid section 330. In a preferred embodiment, the overall dimensions of the earring device may be an outer diameter of 12 to 13 mm, with the dome shaped and / or colored to present a pearl-like appearance or other desired color or pattern. In various alternative embodiments, the device may have a width / diameter of approximately less than 16 mm and more preferably less than 12 mm. The post may have a length of approximately 6 to 8 mm and a diameter of approximately 1 mm, although other posts having lengths of 4.5 mm, 6 mm, 8 mm, and 10 mm and diameters / post thicknesses such as 0.8 mm and 1.2 mm (and / or other sizing known in the art) are contemplated herein as having various design variations. The total weight of each earring may be less than 8 grams, and more preferably less than 5 grams, and desirably incorporates a comfortable and lightweight design and outer contour to allow the user to wear the earring during sleep.

[0063] like Figure 1 and Figure 2 As best shown in FIG. 1 , the base component 120 will desirably be partially and / or completely assembled within the cover 140 (e.g., preferably via seamless exterior and interior molding), with the lower surface of the base positioned adjacent to or against the wearer's skin surface (e.g., the ear surface of the earring embodiment) when the post is contained within the piercing channel. In various embodiments, the device components will desirably be fully sealed and capable of being fully submerged in water, including during bathing and / or showering. In some embodiments, additional waterproof protection may be provided, such as 1 meter, 3 meter, and / or 100 meter waterproof / waterproof measures.

[0064] For one non-limiting example, the cover component may include a small spherical housing, approximately 1 / 4 inch in diameter, containing all electrical components required to operate the wearable sensor and / or biosensor and / or temperature sensor and / or fluid sensor and associated components. Such a design may ideally mimic the outline, shape and / or color of a small pearl earring or similar design.

[0065] While the disclosed embodiment is a one-piece earring, it is contemplated that alternative designs may incorporate a two-piece construction, such as where the earring device includes two portions, including a proximal portion that is capable of being disconnected from a distal portion. For example, the distal portion may include a microtransmitter, other components, and / or at least one wearable sensor as well as a biosensor and a temperature sensor, while the proximal removable portion may include a microbattery. The proximal portion may be connected to the distal portion by means of a post (e.g., containing a temperature sensor and / or other biosensors and / or wearable sensors and / or a microphone and / or a speaker), the proximal portion having the ability to be detached by manually sliding off the post, similar to the back of an earring. By removing the proximal portion of the device, inserting the distal portion of the device through the created cavity, and returning the proximal portion to the device to energize its various components, CCT or other biometrics may be measured and tracked.

[0066] In various embodiments, such as Figure 1As shown in , the column 130 and / or base 120 can desirably incorporate open and / or clear / transparent portions that allow various components to approach the skin surface and / or transmit / receive information from the wearer's anatomical structures, such as LED transmitters and / or sensors for detecting and / or calculating anatomical measurements of the wearer, such as heart rate, pulse, respiratory rate, blood oxygen and / or carbon dioxide levels. A variety of sensor types can be integrated into the device, including a variety of biochemical (enzyme-based, tissue-based, immunosensors, DNA biosensors, and thermal and piezoelectric biosensors), chemical, electromechanical, optical and / or electrical sensors. For example, chemical sensors can be included to measure the concentration level of chemicals in blood, sweat or other body fluids, such as glucose monitors for diabetics and / or lactate level measurements, as well as sensors that measure proteins or hormones, fertility hormones, or other chemical components in sweat (e.g., stress hormones). Similarly, electromechanical sensors may be incorporated to track mechanical motion using electrical measurements, such as accelerometers for measuring physical activity and / or device / wearer orientation, inertial measurement units for measuring angular changes and / or linear acceleration (e.g., for rotational velocity and / or position tracking), or GPS. Optical sensors may be incorporated to detect various biosignals, such as heart rate, heart rate variability, pulse, respiratory rate, oxygen saturation, and / or blood pressure (as well as temperature, galvanic skin response, and / or pressure sensors), which typically include a light source and a photodiode sensor that measures how much light is absorbed, reflected back, and / or passes through adjacent tissue via spectral analysis. Electrical sensors (including bioelectric sensors and electrochemical sensors) may be included to detect, measure, and evaluate electrical signals in the wearer's tissue, including measuring heart rate or brain activity, including electrocardiographic information (e.g., ECG or heart rate monitor), EEG measurements (electroencephalogram), electromyographic measurements (EMG or muscle movement monitor), and / or electrode skin sensors for measuring sweat levels (e.g., sweat monitoring). Other sensors contemplated include pressure sensors, CGM sensors, gyroscopes, GPS receivers, and other wearable sensors.

[0067] In various embodiments, combinations of the following measurements and / or sensors are contemplated (including any combination thereof): temperature, pulse, resting heart rate, heart rate variability (HRV), heartbeat sensors, perfusion, oxygen levels, blood oxygen levels (SpO2), respiratory rate, blood pressure, glucose, hormones, GPS, accelerometers, motion sensors, environmental and / or cavity microphones and speakers.

[0068] When a measuring sensor or wearable sensor (for a non-limiting example a wearable sensor) is integrated into the device, this is ideally a small linear or non-linear rod-like structure located within and / or on a structure that enters or passes through the created artificial cavity, and the sensor is in electronic communication with a circuit board containing the sensor operating software. The wearable sensor can ideally sense or measure temperature or temperature changes continuously or periodically using specific or non-specific time intervals. In a non-limiting example, the sensor is used to accurately detect small temperature changes, measuring on the order of about 1 to 0.01 degrees Fahrenheit. The temperature can be a single sensor unit, or multiple sensors can be used.

[0069] exist Figure 1 In one exemplary embodiment disclosed herein, as shown in , the earring 100 desirably incorporates a plurality of wearable sensors, including at least one temperature sensor located within the post 130 (e.g., a thermistor sensor SC30F103AN commercially available from Amphen Thermometrics, Inc., St. Marys, Pennsylvania, USA), an ambient temperature sensor on the central body 110 (e.g., an NTC thermistor NCP03XH103J05RL commercially available from Murata Electronics North America, Smyrna, Georgia, USA), an accelerometer (e.g., an accelerometer MC3635 commercially available from Meixin Semiconductor Co., Ltd., Zhubei City, Hsinchu County, Taiwan, China), and an optical sensor package, wherein an optical biosensor having proximity sensor and ambient light sensing functions is incorporated (e.g., a Renesas® commercially available from Renesas Electronics Corporation, Tokyo, Japan). OB1203SD-C4). Renesas Electronics Photoplethysmography (PPG) Biosensor integrates light source and driver, analog-to-digital conversion, and I2C communication in a single optical package. Data from the OB1203 Biosensor may be used to determine heart rate (HR), oxygen saturation (SpO2), respiration rate (RR), pulse, and / or heart rate variability (HRV-pressure measurement). In various embodiments, the device may ideally measure one or more of the following: heart rate, heart rate variability, oxygen saturation, respiration rate, 3-axis accelerometer, earlobe cavity temperature, and / or ambient temperature.

[0070] Figure 4 Depiction Figure 3A and Figure 3B FIG. 3 is an exemplary layer cross section of a flexible board 310 showing the various layers within the rigid and flexible segments thereon. Figure 5A and Figure 5B Describe the upper surface of the first rigid segment ( Figure 5A ) and the lower surface of the second rigid segment ( Figure 5B ) on exemplary component positioning and placement. Figures 6A to 6EDescribe the pinhole locations within each layer of the flexible board from top to bottom, and Figures 7A to 7F Depicted from top to bottom are exemplary masking layers in a flexible board. FIG. 8A to FIG. 8C Depiction Figure 1 and Figure 2 A circuit diagram of an exemplary device.

[0071] Fig. 9 A partial perspective view of an ear post 900 having a hollow interior 910 is depicted in which an NTC thermistor 920 (or similar indicator sensing device) is secured. In order for the selected thermistor to fit within the post tube, the tube will ideally have an inner diameter of 0.8 mm and an outer tube diameter of approximately 1.1 mm to 1.15 mm, which should fit comfortably and tightly around an average earlobe piercing. If desired, a thermally conductive sealant or epoxy 930 may be placed within the tube, ideally sealing the tube ends and optionally securing the thermistor against the inner wall of the post. This arrangement ideally seals the cavity enclosed around the post and provides good heat transfer from the earlobe to the tube surface.

[0072] The post may include a variety of materials and / or coatings thereon, wherein the material ideally includes a non-allergenic metal (or other materials including polymers and / or ceramics) having sufficient mechanical rigidity to resist bending and / or collapse during normal wear, and allowing high thermal conduction of body temperature, and the ability to be soldered to wiring and / or mounted directly to a PCB. In the disclosed embodiment, the tube material is a stainless steel hypodermic tube, which may be gold plated for solderability and presents a good visual appearance. The post assembly may have an outer end or distal end (e.g., the end away from the earring assembly passing through the cavity), which is ideally closed and smooth to facilitate and comfortably insert the post into and through the earlobe, and also minimize or prevent the intrusion of any contaminants. The required component materials may include durable medical grade materials, including but not limited to nickel-free metals, plastics, and / or 3D printing resins. Various embodiments of the disclosed device are ideally durable, impact-resistant, and / or waterproof, and suitable for long-term continuous use and operation. The materials and electronic components will provide the strength and ability to be worn continuously during the normal daily activities of the wearer.

[0073] If desired, the post assembly can be attached to the ground plane of the PCB by soldering the open end of the tube to a PCB through-hole, which can act as a ground return for the earring recharging circuit.

[0074] Thermistor 920 will desirably be positioned in direct or intimate contact with the wall of the post, with the thermistor ideally being positioned within the portion of the post that extends outside of the device and will be placed within the earring cavity. As shown, the selected thermistor has a diameter of approximately 0.76 mm, with the small gauge wiring from the sensor ideally extending out of the open end of the tube for soldering to the PCB.

[0075] In many instances, it is highly desirable to integrate multiple different sensing components into a single wearable device. For example, the utility of a temperature sensing component located within a created cavity can be significantly enhanced by combining an LED light and a photosensor component in a location close to the skin surface of the wearer's ear (such as where the base of the device is in close proximity to the skin surface of the ear). Data obtained from such a combined sensing device is very useful during data analysis and / or evaluation, as conclusions obtained from one data stream may be modified and / or refuted by a second data stream and / or reinforced by a third data stream, and so on. Therefore, the present invention contemplates the use of multiple sensor types in a single device, including the use of one type of surface sensor with a more "invasive" second type of sensor - such as a device that resides in the created cavity. In various embodiments, it is desirable to integrate multiple wearable sensing components into a single earring device, including in various embodiments a temperature sensor within a column as previously discussed. Ideally, the column sensor may include an NTC thermistor type that provides a fast response time with an RT curve centered around the normal body temperature range of 95°F to 102°F, preferably with a tolerance of ±0.1°F. As Fig. 9 As best shown in FIG. 1 , the sensor can be positioned within the post assembly such that the sensor is centered and / or otherwise contained within the thickness of the earlobe cavity (eg, between first and second dermis layers relative to the cavity opening) when worn.

[0076] For normal sized adults (e.g., North American individuals), the average earlobe thickness is approximately 3 to 6 mm, so for such individuals, the length of the thermistor within the post tube is ideally approximately 3 to 4 mm within the tube (as measured from the base surface). In some embodiments, the thermistor will be positioned within the post assembly at a location just outside the dome and / or base of the earring, which ideally ensures that the sensor, when worn, will be positioned inside the earlobe piercing and not extend outside and / or behind the earlobe.

[0077] During use, the disclosed device is inserted through an artificially created cavity that provides an area for useful wearable sensor measurements and biometric measurements, such as at least one temperature measurement in CCT, heart rate, heart rate variability, blood oxygen, respiratory rate, pulse, glucose, blood pressure, hormones, and other biosensor measurements. The CCT of the created cavity can be measured by partial or complete closure of the space between the column and / or wearable sensor and / or temperature sensor in the tissue. The cavity ideally has at least one entrance hole and is also accompanied by an exit hole in most typical punctures (although the current device can be easily used in a blind cavity for a single opening puncture). The created cavity can be a linear or non-linear cavity, such as a non-limiting example of a narrow non-linear tunnel, i.e., a navel puncture. The puncture cavity is expected to create a small bounded area (non-limiting example is about 1 mm radius and 5 to 8 mm length) through the wearer's body for temperature measurement of CCT.

[0078] Charging and storage box

[0079] FIG. 10A to FIG. 10C Various views of an exemplary embodiment of a charging and storage case 1000 for an earring device 1010 (or a pair thereof) such as described herein are depicted. The case may include a variety of materials, including polycarbonate and / or polyurethane with a lacquered outer shell (similar to the soft finish clinic white used by current AirPod® devices (which are commercially available from Apple Inc. of Cupertino, California, USA). Other suitable case materials may include acrylonitrile styrene acrylate (ASA) or acrylonitrile butadiene styrene (ABS), as well as other materials known to those skilled in the art. In another preferred embodiment, the charging case resembles a jewelry box or earring case. The case will desirably include a charging port 1020 for connecting to a power source, such as a PCB USB connector Type-C. In the disclosed embodiment, the case may include a hinged or flip-top lid 1030 and a magnetically attached base 1035.

[0080] Fig. 10D and Fig. 10EA view depicting an embodiment of a charging and storage case for an earring device, the case exposing a left earring hole 1040a, a right earring hole 1050a, and one or more auxiliary holes 1060a or recesses for a clasp, backing, or other fastening device when opened. An opening 1070a is provided at the center of each of the left earring hole 1040a and the right earring hole 1050a, each opening 1070a ideally accommodating a corresponding earring post, which ideally provides fastening and charging when the earring is placed in the case. A pair of LED indicators 1080a may be provided that indicate the charge and / or charging status of each earring in the earring, and a similar charge status or other indicator 1090a may be provided on the outer surface of the case to provide the user with earring charging information without requiring the user to open the lid to obtain such information. In the disclosed embodiment, once the earring is fully charged, the LED light may be turned off or change color. In an exemplary embodiment, the battery charge percentage or battery life or battery duration is displayed on or in the charging case. In another exemplary embodiment, the percentage of battery life is transmitted and displayed on the remote software and / or application software.

[0081] In at least one exemplary embodiment, the storage case may incorporate 4 LEDs indicating the following: D1 is the charge status of the internal battery in the charging base, the D3 LED indicates whether the battery in the charging base has stored power (i.e., the earrings can be charged from the case without the charging case being plugged into the wall), and D4 / D5 are LEDs that indicate that each earring is charged. In addition, the charging case incorporates a reset button, i.e., a "power on" reset. If desired, the D4 / D5 components can alternatively be used to power on reset the earrings during an MCU suspend or system reboot. In the current embodiment, the third and fourth LEDs can be used to display individual earring charging status.

[0082] In various embodiments, it is desirable that the earring device be capable of "fast charging" to allow charging to obtain 85% to full battery power (from a completely depleted or "low battery" state) within 2 hours. More preferably, the earring device is ideally capable of "fast charging" to allow charging (from a completely depleted or "low battery" state) to obtain 85% to full battery power within twenty (20) to thirty (30) minutes or ten (10) minutes.

[0083] In an exemplary embodiment, the cartridge may incorporate one or more of the following features:

[0084] Safely charge two (2) earring devices simultaneously or charge one earring individually (e.g., if the other earring is being worn) - Ability to charge individual earrings at different rates (e.g., one earring charges quickly while the other charges slowly or maintains a charge);

[0085] The case contains an internal rechargeable backup battery that powers the charger (and charging earrings) when the case is not attached to an external power source;

[0086] Includes a USB Type C power port and charge controller circuitry for charging an internal backup battery and / or directly charging the earrings;

[0087] Includes various internal and / or externally visible LED status indicators (e.g., independent earring charging status, charging power ready, internal backup battery charging status, linked device status, etc.) or alerts including vibration, noise and / or light notifications.

[0088] Incorporating a hinged lid cover (which may optionally include a magnetically attached hinged lid); and / or

[0089] Includes space such as depressions or holes for earring closures / backings.

[0090] Wireless communication and device linking

[0091] In various embodiments, the disclosed device utilizes a wireless communication modality such as Bluetooth to transmit data (e.g., real-time and / or stored data - including two-way data transmission) between the earring device and a computing service such as a wearer's smart device, smart phone, and / or other computing device / antenna system with minimal power consumption. Such wireless communication may include Bluetooth transmission / reception capabilities (e.g., Bluetooth Low Energy or BLE) with a range of up to 50 feet, but additional wireless communication modalities are contemplated herein, including Wi-Fi and / or cellular connections. In addition, the use of an "airplane mode" and / or limited power consumption mode is contemplated herein.

[0092] An important feature of the present invention is that the earring device is able to link to one or more devices, such as a mobile phone carried by the wearer and / or a computing system accessible to the wearer. It is expected that the earring device can be combined with a low-power wireless communication device, such as a Bluetooth BLE5 communication component, which can use a mobile device application to transmit / pair / link with a mobile or fixed computing device, and provide the sensed data from the earring device to the mobile / fixed computing device. In a preferred embodiment, the mobile / fixed computing device may include a program or computing application (e.g., an APP) that can receive, store and analyze data from the earring device and provide various health indicators and / or conditions of the earring wearer to the wearer and / or other individuals. In various embodiments, the earring device may also be able to receive data via Bluetooth or other communication systems, which can change the function and / or performance of the earring to some desired degree.

[0093] In some embodiments, data logging and / or storage capabilities may be included in the earring device, particularly in situations where real-time data transfer to a computing device is not possible (i.e., the user's smart device is not within BLE range or is in airplane mode).

[0094] In various embodiments, the device will be expected to be EMF safe, and / or have the ability to enter an EMF safe mode (which may be automated or may be user controlled using an associated app). While in such a mode, the device will be expected to continue to collect and / or record data as directed by the user for eventual transmission / download to the app at some point in the future.

[0095] Application Programming

[0096] FIG. 11A to FIG. 11D Various graphical user interface displays (GUIs) are depicted illustrating exemplary embodiments of an application or APP loaded on a mobile phone (e.g., a Samsung S22+ mobile phone available from Samsung Electronics, Inc., USA). In these embodiments, data received from the wearer's sensing device has been transmitted to the wearer's mobile phone, which includes an application (APP) that receives and analyzes the data and provides a summary of the processed data to the wearer. Ideally, much of the process of collecting the underlying data can occur without active intervention by the wearer - but is automated to some important degree. In addition to presenting processed and / or raw data, the various GUIs are also expected to provide various "interpretations" of the data, such as clinical health or health conditions, such as the wearer's fertility ( Fig.11A ), core body temperature ( Fig. 11B ) and / or menstrual cycle history ( Fig. 11C and 11D ).

[0097] For example, the disclosed system components may allow a user to (1) monitor key metrics about their menstrual cycle as well as stress, activity, and sleep, (2) receive personalized insights and actionable feedback based on their unique metrics, (3) gain insight into their fertility, menstrual cycle, and overall health, (4) track their menstrual cycle phases so that the user can adjust their lifestyle accordingly, (5) find the user's monthly fertility window to take control of their reproductive health, (6) track the user's high-stress periods to build resilience amidst the challenges of everyday life, (7) discover activity data and trends to maximize the wearer's performance and results, and / or (8) identify habits and daily activities the wearer needs to achieve optimal health, wellness, and / or sleep.

[0098] A programmed application resident on a computing device expects to receive and record biodata (i.e., CCT temperature, ambient temperature, heart rate, HRV, pulse, respiratory rate, blood oxygen, 3-axis accelerometer) from the earring via Bluetooth technology. The application software code plots the temperature measurements over time for each night of sleep and evaluates whether there is a visually identifiable minimum point in the waveform that is >50% of the time, which is a measure of the relationship of this technology to known physiology. The ovulation date will be calculated using the puncture measurement and controlled based on the wearer's artificial intelligence (AI). The cosine method is used for coding and mathematical calculations. The application software can reside on a mobile phone or similar device with the ability to receive and / or monitor Bluetooth transmissions from the earring. In various embodiments, a single earring can be utilized, although two earrings may be preferred to detect and / or resolve temperature changes on the ear (i.e., such as when the wearer may be sleeping on their side, if the earring falls off, if the wearer's side is turned towards a fan, etc.).

[0099] Fig.12 A non-limiting flow chart showing the data processing of the application applied to CCT measurements or values. When the temperature is sensed, it is transmitted and then recorded wirelessly by the receiver. The receiver records the CCT, which sensing device it came from (used to distinguish different devices when more than one device is used at the same time), and the time in a format that is expected to retain the CCT value. Two or more wearable sensors and / or temperature sensors can be used with a cavity created separately in the body. When more than one wearable sensor and / or temperature sensor is used at the same time, the receiver can obtain all temperature readings. These temperatures can be compared and an algorithm can be applied to derive a temperature value for the time. For example, but not limited to, one sensing device is used in the left ear and the other sensing device is used in the right ear. In a non-limiting example, when the receiver obtains two temperature readings, the lowest temperature value is selected for additional calculations.

[0100] In an exemplary embodiment, the recorded temperature values ​​can be plotted against time and an algorithm applied to find local and global minima and maxima. In addition, the global minimum for a given time period can be plotted for consecutive time periods. For example, but not limited to, a minimum CCT is used on a given night and then implemented over multiple nights. By applying the algorithm to plot the CCT over multiple nights, a quantitative pattern can be determined and an ovulation trend can be revealed. One can then draw conclusions from the ovulation pattern to determine or predict the outcome of a physiological outcome and / or condition.

[0101] The primary algorithm is used to determine local and global minima and maxima; however, various alternative algorithms may be employed. This non-limiting example can be seen where an algorithm is used to calculate IBT or BBT by measuring CCT to help determine fertility.

[0102] Fig.13The use of time-dependent temperature measurements to determine fertility is graphically illustrated. It is known in the art that determining when ovulation occurs can be verified by tracking the rise in body temperature during a woman's reproductive cycle, where the temperature rise occurs suddenly at ovulation. This rise in body temperature is caused by the secretion of progesterone during the second half of the menstrual cycle, which raises body temperature by about half a degree Fahrenheit. In the first half of the menstrual cycle, body temperature fluctuates around 97.2 to 98.0 degrees Fahrenheit, and then over a period of 1-2 days, the body temperature experiences a sharp rise of about one-half degree Fahrenheit or more to around 98.2 to 99.0 degrees Fahrenheit. The body temperature will remain at a higher level until the next menstrual bleeding. Using this information, we can conclude that ovulation occurs on average 1-2 days before the sharp rise in temperature. This small rise in temperature illustrates the need for a temperature sensor that accurately detects small changes of 0.1 to 0.01 degrees Fahrenheit.

[0103] Artificial Intelligence (AI) Processing

[0104] In various embodiments, the measured biodata from the earring may be processed using an artificial intelligence module, which would ideally mine the temperature data (as well as other data received from the device and other information obtained by the AI ​​about the wearer's activities or daily life data). The AI ​​module would ideally correlate and compare previous CCT and other data, attempting to identify relationships and trends between data sets, such as elevated body temperatures during exercise sessions (which could result in artificially high body temperatures for a period of time, thereby simulating an increase in ovulation temperature) or similar indicators. Ideally, the AI ​​module would be able to access wearer data beyond the data sent to the module from the earring. Additionally, over weeks or months of data collection, the AI ​​may be able to identify unique indicators of the wearer's health that would not normally be noticed by a physician, which could help reduce false positives / false negatives and potentially improve the sensitivity and / or accuracy of the data presented by the application and / or early detection of an initiating condition or diagnosis.

[0105] Ideally, the disclosed device can be made to be worn in a manner as simple as wearing an earring, with data transmitted to an application resident on a cell phone that can be carried by the wearer and / or a software platform for remote patient monitoring, healthcare, and clinical monitoring and notifications. The wearable sensor adopts a small, compact design suitable for continuous wear during normal daily or nighttime activities. The size, comfort, wearer friendliness, and hands-free operation enable the wearer to not interrupt daily activities or wake up while the device reads the CCT temperature or other indicators that are useful to the wearer. In addition, the CCT information and / or other indicators can be wirelessly sent to an external processor or memory device to track the temperature and / or other indicators.

[0106] In addition to the collection, analysis, storage and presentation of user data, the application is also expected to include additional features to enable the ability to update and / or improve the performance of the earring device, such as the ability for automatic firmware updates via the data application. Likewise, it is highly desirable that the application be able to push software updates and / or incorporate improvements into the device, such as the ability to add HRV, oxygen, accelerometer and / or other health measurements to existing earring designs, either via software updates or additional components / upgrades.

[0107] Smart Closure / Backing Embodiments

[0108] Fig.14 An alternative embodiment of the disclosed wearable device is depicted that can be used as a closure, backing, or similar attachment device for multiple earrings, including earrings that a wearer may already own prior to acquiring and / or using the disclosed device. In this embodiment, the wearable sensor device 1400 includes a central body 1410 having associated electronic components (and an optional cover) similar to those previously described, but the device includes a post or sleeve 1420 having an opening 1425 formed therein that is desirably capable of engaging and securing to a standard or conventional earring post, which typically ranges in diameter from 21 to 18 gauge (or approximately 0.71 mm to 1.0 mm or 0.028 inches to 0.040 inches). If desired, the sleeve may include a rigid structure or a relatively flexible / expandable material to allow multiple earring post gauges to be accommodated and / or secured therein. Ideally, the device 1400 will include at least one sensor, biochemical sensor, electrical sensor, electrochemical sensor, electromechanical sensor, electrode, optical and / or temperature sensor or thermistor 1430 on an exposed portion of the sleeve 1420. Optionally, in one embodiment, the device 1400 will further include at least one sensor, biochemical sensor, electrical sensor, electrochemical sensor, electromechanical sensor, electrode and / or optical sensor 1450 located on an exposed portion of the base 1440. Sensors may include, but are not limited to, accelerometers, optical sensors, biochemical sensors, bioelectric sensors, electrochemical sensors, pressure sensors, CGM sensors, gyroscopes, GPS and other wearable sensors, LED sensors for heart rate, HRV, respiratory rate, blood oxygen, pulse, motion accelerometers, activity, calories, distance walked, steps, LED sensors and blood pressure pressure sensors, CGM sensors for glucose monitoring, gyroscopes for angular velocity measurement, global positioning system (GPS), magnetometers for magnetic measurement, electrochemical sensors for hormone and other bio-sensing, and speakers and / or microphones for music, phone calls.

[0109] like FIG. 15A to FIG. 15CAs best shown in FIG. 1 , the disclosed backing sensor device 1400 may be compatible with or may be used with a variety of earring shapes and / or types ( Fig.15A ). The backing sensor device can be placed on or around the earring post in a sleeved or sheathed manner (see Fig. 15B ), and the sleeve will then be expected to travel along the post, and the sleeve and sensor expected to enter the created cavity (depicted as the first skin wall 1510 and the second skin wall 1520 of the ear) from the back of the ear (the sleeve and sensor expected to be thin enough to slide between the post and the cavity wall during use - see Fig. 15C ), thereby providing accurate measurement of the created cavity temperature and other biosensor measurements as previously described. Similarly, the base of the central body base 1440 may include additional sensing components, lights, etc. as previously described (as well as open and / or transparent sections to accommodate such components) to allow measurement and assessment of various wearer characteristics as described herein.

[0110] It should be understood that this alternative embodiment can include any of the previously described components and / or capabilities, as well as associated charging case components and application software for linking to a computing device. In this way, a wearer can utilize system components with multiple earring designs that can be switched daily or more frequently without interfering with data collection and analysis as described herein.

[0111] If desired, the closure device can be configured to work with different types of earring posts, including posts, push-back pins, screw posts, hinged hoops, latches, levers, springs, huggers, French clips, and / or other clasp types known in the art.

[0112] Equivalent

[0113] Although the present subject matter has been described in detail with respect to its specific embodiments, it should be understood that those skilled in the art can easily produce changes, variations and equivalents to such embodiments after understanding the foregoing. Therefore, the scope of the present disclosure is exemplary rather than restrictive, and the present subject matter disclosure does not exclude such modifications, variations and / or additions to the present subject matter, which are obvious to a person of ordinary skill in the art.

[0114] Therefore, although exemplary embodiments of the present invention have been shown and described, it should be understood that all terms used herein are descriptive rather than limiting and that many changes, modifications and substitutions may be made by those skilled in the art without departing from the spirit and scope of the present invention.

[0115] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

[0116] The various titles and headings used herein are for the convenience of the reader and should not be construed to limit or restrict any features or disclosures thereunder to a particular embodiment or embodiments. It should be understood that various exemplary embodiments may incorporate various combinations of the various advantages and / or features described, all of which are contemplated and expressly incorporated below.

[0117] The use of the terms "one" and "an" and "the" and similar indicators in the context of describing the present invention should be interpreted as covering both the singular and the plural, unless otherwise specified or clearly contradictory herein. Unless otherwise specified, the terms "include", "have", "have" and "include" should be interpreted as open terms (i.e., meaning "including but not limited to"). Unless otherwise specified, the enumeration of numerical ranges herein is intended only to be used as a shorthand method for individually referring to each individual value falling within the range, and each individual value is incorporated into the specification as if it were individually quoted here. All methods described herein can be performed in any suitable order, unless otherwise indicated herein or otherwise clearly contradictory to the context. The use of any and all examples or exemplary language (e.g., "such as") provided herein is intended only to better illustrate the present invention, and is not intended to limit the scope of the present invention, unless otherwise claimed. Any language in the specification should not be interpreted as indicating that any unclaimed element is necessary for the practice of the present invention.

[0118] Preferred embodiments of the present invention are described herein, including the best mode known to the inventor for implementing the present invention. After reading the foregoing description, changes in those preferred embodiments will be apparent to those of ordinary skill in the art. The inventor expects that the skilled person will appropriately adopt such changes, and the inventor intends to practice the present invention in a manner different from that specifically described herein. Therefore, the present invention includes all modifications and equivalents of the subject matter recorded in the appended claims as permitted by applicable law. In addition, unless otherwise specified herein or clearly contradictory to the context, the present invention encompasses any combination of the above-mentioned elements in all possible variations thereof.

Claims

1. A device for continuously monitoring a physiological condition of a wearer having an artificially created cavity in living tissue, the artificially created cavity being defined by a first hole in the body tissue and a second hole in the body tissue opposite the first hole, the device comprising: a central body having a first sensor component positioned outside the artificially created cavity at a location adjacent to the skin surface of the wearer, the first sensor providing a first signal that is a measurement of a first physiological condition of the wearer, either continuously or periodically with specific time intervals, and a body piercing device post configured to be inserted and worn in the artificially created cavity, the body piercing device post being sized to pass through at least the first hole in the body tissue and inserted into the artificially created body tissue cavity, the body piercing device post comprising a second sensor component positioned within the artificially created body tissue cavity and providing a second signal, the second signal being a measurement of a second physiological condition of the wearer, either continuously or periodically using specific time intervals; a transmitter configured to wirelessly transmit the first and second measurements continuously or periodically to a remote receiver for recording, the transmitter being located within the central body so that, in use, it is located outside the artificially created cavity; and The device further includes at least one power source for powering the first and second sensors and the transmitter.

2. The sensing device according to claim 1, wherein: The first sensor measures the wearer's blood oxygen and the second sensor measures the wearer's temperature.

3. The sensing device according to claim 1, wherein: The first sensor measures the wearer's blood pressure and the second sensor measures the wearer's temperature.

4. The sensing device according to claim 1, wherein: The first sensor measures the wearer's blood oxygen and the second sensor measures the wearer's glucose level.

5. The sensing device according to claim 1, wherein: The sensor is removable by the wearer.

6. A device for continuously monitoring a physiological condition of a wearer having an artificially created cavity in living tissue, the artificially created cavity being defined by a first hole in the body tissue and a second hole in the body tissue opposite the first hole, the device comprising: a central body having a first sensor component positioned outside the artificially created cavity at a location adjacent to the skin surface of the wearer, the first sensor providing a first signal that is a measurement of a first physiological condition of the wearer, either continuously or periodically with specific time intervals, and a cannula for receiving a body piercing device post, the body piercing device post extending through the artificially created cavity, the cannula including an extension portion substantially surrounding the post and entering the artificially created cavity, the extension portion containing a second sensor component positioned within the artificially created body tissue cavity and providing a second signal, the second signal being a measurement of a second physiological condition of the wearer either continuously or periodically using specific time intervals; a transmitter configured to wirelessly transmit the first and second measurements continuously or periodically to a remote receiver for recording, the transmitter being located within the central body so that, in use, it is located outside the artificially created cavity; and The device further includes at least one power source for powering the first and second sensors and the transmitter.

7. The sensing device according to claim 6, wherein: The first sensor measures the wearer's blood oxygen and the second sensor measures the wearer's temperature.

8. The sensing device according to claim 6, wherein: The first sensor measures the wearer's blood pressure and the second sensor measures the wearer's temperature.

9. The sensing device according to claim 6, wherein: The first sensor measures the wearer's blood oxygen and the second sensor measures the wearer's glucose level.

10. The sensing device according to claim 6, wherein: The sensor is removable by the wearer.

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