Fabricated cavity biosensor

Abstract

Disclosed herein are wearable devices, systems, and associated methods for sensing various anatomical conditions and / or metrics of a wearer, including measuring and optionally transmitting data to a computing device that analyzes the data to determine various physiological conditions in and / or near the wearer's body. The devices include a central body with a first sensor and body piercing posts with a second sensor, the sensors continuously or periodically measuring the wearer's first and second physiological conditions, respectively, using specified time intervals.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 389,891, filed July 17, 2022, entitled "CREATED CAVITY BIOMETRIC SENSOR," the entire disclosure of which is hereby incorporated by reference into this specification.

[0002] The present invention relates to wearable devices and associated system components that sense, measure, transmit, and present various data regarding physiological conditions within and / or near the wearer, such as vital signs, biometric data, and temperature within an artificially created cavity (Created Cavity Temperature, or "CCT"). [Background technology]

[0003] The Quantified Self is a movement that incorporates technology, communication, measurement, quantification, and / or evaluation of data, including self-tracking data, to improve an individual's or group's physical, mental, and emotional health, as well as personal wellness and daily functioning through the use of self-tracking data. As the Quantified Self movement grows, consumers continually seek to leverage technology to obtain additional data about inputs (e.g., food intake, ambient air quality), conditions (e.g., blood oxygen levels, body temperature), and / or performance in their daily lives. This self-monitoring concept combines environmental and / or wearable sensors with computing devices to improve daily functioning and generate outputs that enable users to more accurately track and optimize their health.

[0004] Growing consumer interest in personal health has led to the availability of a variety of personal health monitoring devices on the market. For example, wearable electronic devices for monitoring personal health, including electronic measurement devices that can be worn on fingers, wrists, or other body parts, are widely known in the art. These devices typically contain electronic components such as flexible printed circuit boards, processors, sensors, and batteries and are worn near and / or on the skin. They can detect, analyze, and transmit information about vital signs and other body signals and environmental data, and in some cases provide immediate biofeedback to the wearer. Wearable devices, such as activity trackers, also known as wearables, fashion technology, smartwear, techtogs, streetwear tech, skin electronics, and fashion electronics, are an example of the Internet of Things (IoT). These devices are "things"—electronics, software, sensors, and connectivity—that function as effectors, capable of exchanging data with manufacturers, operators, or other connected devices and via the Internet, without the need for human intervention. Wearables are popular consumer electronics and are commonly available in form factors such as smartwatches, smart rings, and implants. Specific examples include the FitBit monitor sold by FitBit Inc. (San Francisco, California, USA), the Apple Watch sold by Apple Inc. (Cupertino, California, USA), the Samsung Gear Fit2 bracelet sold by Samsung Electronics Co., Ltd. (Suwon, South Korea), and the Oura ring sold by Oura Health Inc. (Oulu, Finland). Many wearable devices measure various bodily conditions on the human skin, such as body temperature, heart rate variability, blood oxygen level, pulse rate, and respiratory rate, and often perform other functions as well. Summary of the Invention [Means for solving the problem]

[0005] At least one aspect of the present invention addresses a need in the art for the development of a wearable device for daily and / or overnight measurement of a wearer's numerous physiological conditions, including, but not limited to, one or more of the wearer's body temperature, resting heart rate, active heart rate, heart rate variability, oximetry, blood oxygen levels, resting pulse rate, active pulse rate, respiration rate, movement, sleep, blood glucose, blood pressure, and / or SpO2 sensing. There is a need for accurate and useful monitoring, including changes in an individual's body temperature during daily activities and sleep. There is also a need for physiological condition monitoring devices that provide constant monitoring through easily accessible devices within the home. Such devices could contribute to the development of the quantified self movement by providing a controllable self-tracking approach to understanding various health issues and related conditions, such as fever, stress, seizures, physical activity levels, sleep and sleep patterns, women's health, menstrual health, general well-being, infections, viral exposure, pregnancy, perimenopause, menopause, infertility, and / or fertility. Additionally, the disclosed devices and related systems may significantly benefit the public health sector by identifying health problems at an earlier stage, potentially reducing healthcare costs by eliminating undiagnosed or unaddressed health concerns, women's health, menstrual health, the need for excessive physician visits, and / or providing an alternative to chemical-based testing procedures such as infertility determination.

[0006] In a specific embodiment, the present invention provides a device for measuring useful body temperature, resting heart rate, activity heart rate, heart rate variability, oximetry, blood oxygen concentration, resting pulse rate, activity pulse rate, respiration rate, movement, sleep, and / or SpO2 sensing via an artificially created cavity within the human body (generally meaning a body cavity within the device wearer that is not the result of natural anatomy). In humans, temperature measurements can be made at a wide range of sites, including the surface of the skin, the axilla or underarm and / or groin, and even within existing body cavities such as the mouth, ear, nasal cavity, esophagus, rectum, pulmonary artery, urethra, or bladder. While superficial sites such as the skin, axilla, and groin are often used to measure patient temperature due to their ease of access, measurement accuracy at these sites is often compromised by a variety of factors, including sweating, ambient air circulation, humidity, the use of blankets, and peripheral vasoconstriction. Deeper body sites (e.g., esophagus, bladder, rectum) typically reflect core body temperature more accurately, but accessing and continuously monitoring these sites requires significant implementation and setup effort, and such monitoring significantly restricts the wearer's movements and daily activities. While existing natural body cavities and / or orifices can provide temperature measurements for a variety of applications, naturally occurring body cavities are also used for many other daily activities (e.g., eating, breathing, speaking, hearing). As such, measurement devices placed within such cavities typically interfere with or substantially impair other daily activities during the measurement. Furthermore, placing and / or placing a monitoring device within a naturally occurring body cavity typically is uncomfortable for the wearer over long periods of time and is often aesthetically unpleasing. However, the formation of an artificial cavity allows repeated and / or continuous access to various tissues and / or tissue regions and planes located below the skin surface, including subcutaneous and / or subcutaneous anatomical regions that more accurately reflect the wearer's body temperature, and by placing the measurement device within the artificial cavity, the desired effect can be achieved without interfering with the wearer's movements or daily activities.

[0007] In various embodiments, the device can measure sensed cavity temperature or created cavity temperature (CCT). Depending on the location of the artificial cavity and the patient's unique anatomy, CCT may closely reflect one or more of core body temperature (CBT), basal body temperature (BBT), internal body temperature (IBT), and / or surface body temperature (SBT), although the temperature within the created cavity does not necessarily correlate with CBT, BBT, IBT, and / or SBT. In one non-limiting example, the cavity may be a piercing cavity in the human earlobe. The human earlobe is a fleshy, soft part of the outer ear that receives a large blood supply from the posterior auricular branch of the external carotid artery, and therefore its blood supply is highly reflective of internal temperature. The disclosed device may have a size, shape, and / or weight similar to pearl stud earrings (or other decorative fashion and / or functional ear jewelry) and can be worn during sleep to monitor a woman's ovulation trends. The created cavity may have resulted from a piercing procedure performed many years prior to the acquisition of the presently disclosed device. In this example, the device is inserted into the cavity created through two holes (entrance and exit) originally formed by the piercing procedure. In other non-limiting examples, the device may resemble a navel stud and / or ring, nose stud / ring, eyebrow stud / ring, lip stud / ring piercing, tongue stud / ring piercing, genital stud / ring piercing, or other body piercing.

[0008] 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 fabricated cavity. The sensor operates periodically or continuously at specified time intervals, and the device reads the temperature periodically or continuously. Various temperature or other indicator sensing devices are contemplated herein, such as 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.

[0009] According to at least one exemplary embodiment, the post of the device is sized and configured to nearly completely or completely occupy the created cavity, nearly completely closing the gap between the opening of the cavity into which the device is inserted. If desired, contact between the base of the earring and the corresponding clasp on the opposing ear surface helps to assist in maintaining a stable temperature measurement within the created cavity.

[0010] Various embodiments disclosed herein utilize an artificially created physiological cavity, such as a piercing cavity, preferably extending between two adjacent skin surfaces of the human body. Within this artificial cavity, the device may include sensors or other devices that measure CCT and / or other bodily conditions, which preferably address the wearer's core body temperature or other desired temperature in some way. Essentially, the created cavity is not naturally present in the human body, but rather is "added" to the wearer's body for various reasons. Of course, depending on the device design and the wearer's natural anatomy, it is contemplated that natural cavities or openings may be utilized by the device for some wearers.

[0011] In various embodiments, the devices disclosed herein are capable of accurately measuring both the temperature within the wearer's artificially created physiological cavity and the temperature of the external environment, such as the ambient air or water temperature (e.g., when swimming, tubing, or bathing). These temperature measurements can be periodically and / or continuously recorded and / or transmitted to a computing device, such as a cell phone or computer. Because external temperature fluctuations often affect various patient temperature measurements, performing external temperature measurements simultaneously with sensed physiological temperature measurements can greatly improve the accuracy and reliability of the system.

[0012] Similarly, some embodiments of the disclosed devices may include various additional components and / or sensors located within, within, adjacent to, or near the wearer's artificially created cavity. These may be used to detect other wearer activity, such as accelerometers, GPS sensors, LED sensors, pressure sensors, and other sensors that can measure the wearer's movement and activity level. Such additional measurement capabilities may desirably further improve the accuracy and / or reliability of the system by incorporating data reflecting wearer events or occurrences that may affect the accuracy and / or reliability of the internal temperature measurement. This may include providing the ability to detect, analyze, highlight, or filter out various data points or trends detected by the system (including anomalous or unexpected readings), particularly when artificial intelligence (AI) systems are used to analyze the resulting wearer data.

[0013] In various embodiments, the wearable device may further include a small transmitter / receiver with any wireless communication components. One or more batteries may be incorporated into the wearable device to power these components, and small, low-power rechargeable battery components may be used to power various parts of the system.

[0014] The system should be designed to be small, compact, and lightweight, for example, by using various combinations of rigid and / or flexible materials in the design to enhance comfort and ease of wearing while sleeping at home and during daily activities.

[0015] In operation, the system is used to measure CCT and other anatomical information, and the information is used to track and / or derive medically useful information, contemplated for use in hospitals as a vital signs and biodata monitoring system for fertility, menstrual cycle health, blood pressure, heart health, respiratory and lung health, fever, illness, acute pain, chronic disease, or continuous temperature. A wide variety of applications 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, physical fitness, gut health, diabetes, obesity, asthma, premenstrual syndrome, polycystic ovarian syndrome, endometriosis, perimenopause, menopause, osteoporosis, menstrual irregularities, urinary tract infections, heart disease, eclampsia, chronic obstructive pulmonary disease, women's health, wellness management, stress, sleep, diet / calorie counting, activity / fitness, sports, government health, military, agriculture, etc. [Brief explanation of the drawings]

[0016] A full and enabling disclosure, including the best mode thereof, to one skilled in the art, is set forth more particularly in the remainder of the specification, including reference to the accompanying drawings, in which: Figures illustrate certain aspects of the invention and, together with the description, serve to explain the principles of the invention in a non-limiting manner. Like reference characters used herein refer to like parts throughout the several views.

[0017] [Figure 1] FIG. 1 illustrates an exploded perspective view of one embodiment of a wearable sensing device in the shape and form of a post-type earring. [Figure 2] FIG. 2 is a diagram showing the wearable sensing device of FIG. 1 after assembly. [Figure 3A] 3A through 3F are various views of the flexible substrate and battery of the wearable sensing device of FIG. [Figure 3B] 3A through 3F are various views of the flexible substrate and battery of the wearable sensing device of FIG. [Figure 3C] 3A through 3F are various views of the flexible substrate and battery of the wearable sensing device of FIG. [Figure 3D] 3A through 3F are various views of the flexible substrate and battery of the wearable sensing device of FIG. [Figure 3E] 3A through 3F are various views of the flexible substrate and battery of the wearable sensing device of FIG. [Figure 3F] 3A through 3F are various views of the flexible substrate and battery of the wearable sensing device of FIG. [Figure 4] 3C illustrates an exemplary layer cross-section of the flexible substrate of FIGS. 3A and 3B. FIG. [Figure 5A] 3C illustrates a first surface of the flexible substrate of FIGS. 3A and 3B and a layout of components. FIG. [Figure 5B] 3C illustrates a second side of the flexible substrate of FIGS. 3A and 3B and a layout of components. FIG. [Figure 6A] 6A to 6E are diagrams showing the positions of pinholes in each layer of the flexible substrate of FIGS. 3A and 3B from top to bottom, respectively. [Figure 6B] 6A to 6E are diagrams showing the positions of pinholes in each layer of the flexible substrate of FIGS. 3A and 3B from top to bottom, respectively. [Figure 6C] 6A to 6E are diagrams showing the positions of pinholes in each layer of the flexible substrate of FIGS. 3A and 3B from top to bottom, respectively. [Figure 6D] 6A to 6E are diagrams showing the positions of pinholes in each layer of the flexible substrate of FIGS. 3A and 3B from top to bottom, respectively. [Figure 6E] 6A to 6E are diagrams showing the positions of pinholes in each layer of the flexible substrate of FIGS. 3A and 3B from top to bottom, respectively. [Figure 7A] 7A to 7F are diagrams showing the mask layers of the flexible substrate of FIGS. 3A and 3B from top to bottom, respectively. [Figure 7B] 7A to 7F are diagrams showing the mask layers of the flexible substrate of FIGS. 3A and 3B from top to bottom, respectively. [Figure 7C] 7A to 7F are diagrams showing the mask layers of the flexible substrate of FIGS. 3A and 3B from top to bottom, respectively. [Figure 7D] 7A to 7F are diagrams showing the mask layers of the flexible substrate of FIGS. 3A and 3B from top to bottom, respectively. [Figure 7E] 7A to 7F are diagrams showing the mask layers of the flexible substrate of FIGS. 3A and 3B from top to bottom, respectively. [Figure 7F] 7A to 7F are diagrams showing the mask layers of the flexible substrate of FIGS. 3A and 3B from top to bottom, respectively. [Figure 8A] 8A-8C are exemplary circuit diagrams of the wearable sensing device of FIG. [Figure 8B] 8A-8C are exemplary circuit diagrams of the wearable sensing device of FIG. [Figure 8C] 8A-8C are exemplary circuit diagrams of the wearable sensing device of FIG. [Figure 9] FIG. 2 illustrates a sensor disposed within a stud post assembly of the wearable sensing device of FIG. 1. [Figure 10A] 10A-10C show various views of one embodiment of a charging and storage case for the wearable sensing device of FIG. [Figure 10B]10A-10C show various views of one embodiment of a charging and storage case for the wearable sensing device of FIG. [Figure 10C] 10A-10C show various views of one embodiment of a charging and storage case for the wearable sensing device of FIG. [Figure 10D] 10A-10C illustrate alternative embodiments of a charging and storage case for an earring device. [Figure 10E] 10A-10C illustrate alternative embodiments of a charging and storage case for an earring device. [Figure 11A] 11A through 11D are diagrams illustrating various graphical user interface displays (GUIs) of an exemplary embodiment of an application program or APP loaded onto a mobile phone. [Figure 11B] 11A through 11D are diagrams illustrating various graphical user interface displays (GUIs) of an exemplary embodiment of an application program or APP loaded onto a mobile phone. [Figure 11C] 11A through 11D are diagrams illustrating various graphical user interface displays (GUIs) of an exemplary embodiment of an application program or APP loaded onto a mobile phone. [Figure 11D] 11A through 11D are diagrams illustrating various graphical user interface displays (GUIs) of an exemplary embodiment of an application program or APP loaded onto a mobile phone. [Figure 12] FIG. 10 shows an example flowchart of data processing applied by an application to a CCT measurement or measurements. [Figure 13] FIG. 10 shows a graph of an example of temperature measurement over time for determining fertility. [Figure 14] 10A-10C illustrate an alternative embodiment of a wearable sensing device used as a clasp for multiple earrings, a backing, or similar attachment device. [Figure 15A]15A-15C show a series of existing earrings before being secured with the wearable sensing device of FIG. 14. [Figure 15B] 10A-10C illustrate advancing a wearable sensing device onto an earring post. [Figure 15C] FIG. 1 illustrates a wearable sensing device secured to an earring post, with the sensor positioned within the piercing cavity of a human ear. DETAILED DESCRIPTION OF THE INVENTION

[0018] Reference will now be made in detail to various embodiments of the presently disclosed subject matter, one or more examples of which are set forth below. Each embodiment is provided to illustrate, not limit, the subject matter. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the disclosure. For instance, features illustrated or described as part of one embodiment can be used with another embodiment to yield a still further embodiment. Accordingly, the present disclosure is intended to cover modifications and variations that come within the scope of the appended claims and their equivalents.

[0019] Ranges may be expressed herein as from "about" one particular value, and / or to "about" another particular value. When such a range is expressed, another embodiment includes from the one particular value and / or to the other particular value. Similarly, when values are expressed as approximations, by use of the word "about," it will be understood that the particular value constitutes another embodiment. Further, it will be understood that the endpoints of each range are significant both in relation to the other endpoint, and independently of the other endpoint.

[0020] As used herein, "optional" or "optionally" means that the described event or circumstance may or may not occur, and the description includes both cases where the event or circumstance occurs and cases where it does not occur.

[0021] This disclosure also incorporates the disclosure of U.S. Patent No. 10,117,643, entitled "Created Cavity Temperature Sensor," filed April 25, 2015, the entire disclosure of which is hereby incorporated by reference. The components disclosed herein may be utilized in systems and / or methods for monitoring characteristics of humans and other animals, including the inventions and concepts shown and described in U.S. Patent No. 10,117,643 to Gevaert et al.

[0022] The present disclosure generally relates to devices for measuring various physiological conditions of a wearer, which may include useful measurements such as body temperature and / or its variations over time, heart rate, respiratory rate, blood oxygen level, pulse, movement, activity, calories, distance traveled, steps, blood pressure, glucose monitoring, angular velocity measurements, position (e.g., global positioning), magnetic field measurements, and sensing of ambient noise and other conditions.

[0023] More specifically, the device can measure cavity temperature (CCT) within living tissue or an artificial cavity within the wearer's body into which the device is inserted. This latest device provides a wearable thermometer that continuously or periodically measures temperature as a convenient and comfortable way to continuously track the wearer's body temperature. Alternatively or in combination, the device may include an LED sensor for measuring heart rate, respiration rate, blood oxygen level, and / or pulse. Alternatively or in combination, the device may include an accelerometer for measuring movement, activity, calories, distance traveled, and 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 blood glucose monitoring. Alternatively or in combination, the device may include a gyroscope for measuring angular velocity. 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 measurements. Alternatively or in combination, the device may include a microphone and speaker that can be used to monitor the surrounding environment, listen to music, answer phone calls, and so on.

[0024] Cavity creation

[0025] It should be understood that while the disclosed devices can be utilized in a variety of locations on the human body, for many people, body piercing locations such as one or both earlobes may be particularly favored (and such locations may already be pierced to allow for various adornments). Various piercing locations may be suitable for measuring a wide variety of data, including biometric measurements, temperature, resting heart rate, active heart rate, heart rate variability, heart rate sensing, oxygen sensing, blood oxygen level, blood pressure, resting pulse rate, active pulse rate, perfusion, respiratory rate, movement, sleep, SpO2, and / or blood glucose, bacteria, white blood cell count, protein, lipids, salts, fat (or other body fluid properties, including lymph and other body fluid properties), as well as location information (via GPS), sound sensor, and accelerometer data. In some cases, localized body conditions near a particular piercing location may be particularly suitable for measuring various physiological conditions, such as, for example, a tongue piercing for glucose measurement or blood sugar tracking.

[0026] The disclosed CCT is a measurement that can be obtained from an artificially created cavity in a wearer's body, where the created cavity is artificially formed, such as, by way of non-limiting example, a puncture procedure for an earring. Furthermore, two or more artificially created cavities may be utilized to measure the CCT in a single body. By way of non-limiting example, two different biosensing or wearable sensing devices may be used in two different created cavities to simultaneously measure two CCT values (or other anatomical metrics) in the separate created cavities. Furthermore, these various sensing devices may be used to derive a single CCT (or other anatomical metric). It should be understood that the CCT (or other anatomical indicator) may be different when obtained from other artificial cavities created in the same wearer's body. This is because anatomical differences may cause local temperature variations (e.g., the CCT or other metric of an ear piercing may be different from the CCT or other metric of a piercing in the navel or tongue in the same wearer, or the CCT or other metric of left and right ear piercings may differ from each other for environmental and / or anatomical reasons).

[0027] The disclosed devices desirably can measure CCT or other metrics within the created cavity for tracking the wearer's effective temperature or for other purposes. Aspects of the created cavity are further described below. CCT may or may not be the same temperature measurement as 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 understood because the temperature within the created cavity need not be equal to and / or correlate with CBT, IBT, BBT, BCT, and / or SBT. Furthermore, CCT measurements may be appropriate even if they are perfectly consistent, higher, lower, or do not have a 1:1 relationship with body temperature.

[0028] The disclosed device offers a practical design that provides a comfortable, convenient, and unobtrusive way for the wearer to continuously or periodically track body temperature and other biometric measurements while sleeping, resting, or active. For example, the device may resemble a small stud earring structure that can be worn on the body, including, but not limited to, through the wearer's earlobe, navel, tongue, nose, eyebrows, lips, genitals, and / or other body parts. The device allows for wireless communication to an external system for tracking the continuous or periodic measurements, and can be used, by way of non-limiting example, to determine fertility by identifying changes in body temperature associated with the biological event of ovulation.

[0029] The disclosed device obtains cavity temperature and / or other measurements from the wearer over a specified period of time. As a non-limiting example, cavity temperature measurements may aid in determining fertility. In this example, measurements are evaluated to identify local minima during a night's sleep, where a local minima is defined by the lowest measurement within a pre-set time period. The local minima can then be plotted relative to time to identify trends in fertility. Additionally, measurements can be tracked over a 24-hour period and patterns can be compared between different days and nights to identify or predict, for example, the wearer's ovulation date.

[0030] Ovulation and fertility detection

[0031] According to the Centers for Disease Control and Prevention (CDC), 12.3% (7.5 million) of American women ages 15 to 44 have a disorder affecting their ability to conceive or sustain a pregnancy. Forty percent of these women have ovulation disorders, a clinical condition in which ovulation occurs internally, is not typically monitored, and progresses rapidly over a short period, making it difficult to identify. Identifying each affected woman's rapidly changing ovulatory cycle requires frequent monitoring during the estimated ovulatory window. Furthermore, rhythm methods (e.g., tracking menstrual cycles on a calendar to predict ovulation) are more than 75% effective in preventing unwanted pregnancy, yet less than 1% of women ages 15 to 44 currently use this highly effective natural contraceptive method.

[0032] The need for frequent monitoring when predicting ovulation for pregnancy and contraception purposes currently places a significant burden on patients. Basal body temperature (BBT) recording is a known and safe method for monitoring ovulation, and compared with blood tests and ultrasound, it has the advantage of being able to be monitored by patients themselves at home without the need for adjusting clinical schedules or visiting a clinic, minimizing costs and risks. However, the application of the BBT method is limited by the inconvenience of having to measure and record body temperature immediately after waking at the same time each morning. Patient adherence is particularly low, and even for those who adhere, the difficulty in interpreting the information often leads to frustration.

[0033] Conventional ovulation thermometers help track a woman's ovulation trends by measuring her basal body temperature (BBT) through natural body cavities. However, these devices do not provide the most accurate ovulation results because they rely on temperature measurements taken with an inconvenient thermometer after waking. The disclosed device and associated system components, on the other hand, are expected to eliminate the need to wake up before taking a temperature measurement, as low temperatures do not necessarily occur upon waking, and more accurately identify low temperatures during a given night's sleep. This is achieved through a small, wearable sensor, such as a temperature sensor, placed within an artificial cavity in the body. The sensor provides continuous or periodic measurements of CCT (temperature within the artificial cavity), which are wirelessly transmitted to the wearer's associated smart device for analysis.

[0034] In one exemplary embodiment, the disclosed earring technology and system conveniently monitors ovulation by measuring basal body temperature (BBT) using an earring sensor. The sensor resembles the earrings worn daily by many American women. Home monitoring reduces patient inconvenience and expense, enabling more equitable care delivery. Furthermore, the device's uses extend far beyond fertility treatment, including reproductive management for ovulation identification and pregnancy prevention, health tracking assistance, infectious disease and COVID monitoring, early pregnancy detection, natural contraception assistance, identification of pregnancy, labor, and the onset of menopause, and tracking the wearer's menstrual cycle and other health indicators. In various embodiments, the earring may also include notifications (i.e., sound, vibration, light, or electrical pulse notifications) of important information to the wearer. This may include proximity and non-proximity notifications (i.e., smartphone theft prevention), emails, text messages, updates, or incoming phone calls. The disclosed device and associated system components provide the ability to obtain information based on early detection of health issues or conditions, such as infectious diseases, COVID-19, viruses, pregnancy, premature birth, premenopausal symptoms, women's health issues, or the need for specific medications or vitamins. The device also demonstrates other medical applications, such as fever and illness detection, as non-limiting examples. Furthermore, the device can be used to derive information for medical tracking and implemented in hospitals where continuous or periodic temperature, vital signs, and biometric monitoring are required. Additional applications contemplated herein include, but are not limited to, fertility treatment, natural family planning, COVID infection and symptoms, infectious disease signs and susceptibility, cancer diagnosis and treatment, long-term hospitalized patient monitoring, fever detection and treatment, thyroid issues, gut health, diabetes detection and management, obesity, asthma, heart disease, chronic obstructive pulmonary disease, women's health issues, wellness monitoring, stress management, sleep monitoring and disorder detection and treatment, diet and calorie counting, activity / fitness tracking, sports, government health management, military, and agriculture.

[0035] Device design and dimensions

[0036] The present invention includes multiple individual components that are assembled into an earring or other piercing device; by way of non-limiting example, the device may measure approximately ½ inch by ½ inch, preferably ¾ inch by ¼ inch, and most preferably ½ inch by ¼ inch, although a wide range of device sizes, shapes, weights, and / or designs are contemplated by the present disclosure. In general, it is desirable for the device to fit comfortably within a created cavity, such as an ear piercing (or other piercing), and to be sized and / or shaped to conform to the anatomical structures surrounding the device (e.g., adjacent skin surfaces, earlobe, etc.). It is also desirable to minimize the weight of the device whenever possible to reduce stress or injury to the body part (e.g., earlobe, etc.) on which the device is worn.

[0037] 1 is a simplified exploded perspective view of a body-worn sensing device in the form of a post-type earring 100. The earring 100 includes a central body 110, a base 120, a post 10, a surface dome or cover 140, and a clasp or backing 150.

[0038] As clearly shown in Figures 3A-3D, the central body 300 may include a semi-flexible, flexible, or flexible circuit board 310 having a first rigid section 320, a second rigid section 330, and a flexible linkage 340 disposed therebetween connecting the two rigid sections. The two rigid sections are preferably circular in shape to fit within a dome-shaped enclosure. Exemplary dimensions for the flexible board component include a thickness of 825 μm (±120 μm) for each rigid section, a diameter of approximately 10 mm, a width of 3.48 mm, and a thickness of 133 μm (±50 μm) for a 6 mm long flexible section with a 0.55 mm radius.

[0039] In the illustrated embodiment, the power source or battery 350 may be located or sandwiched between the first and second rigid sections due to size considerations and / or various other reasons, although various component configurations and / or arrangements may be utilized by one skilled in the art of circuit design. In various embodiments, the disclosed device is capable of measuring the wearer's temperature and other vital signs or biometric data (and / or other measurements) via the earring post in the ear piercing at least every 15 minutes for at least 8 hours before requiring another charge, preferably using minimal power. More preferably, the disclosed device is capable of measuring the wearer's temperature via the earring post in the ear piercing every 15 seconds for at least 24 hours before requiring another charge. As described herein, a carrying and / or storage case for the earring may incorporate battery charging capabilities integrated into the carrying and storage case.

[0040] Any of the components described herein may use various types of batteries, including film, flexible, rechargeable, non-rechargeable, electronically charged, solar-powered charged, trickle charged, and battery maintainers.

[0041] 3C and 3D show the flexible substrate 310 shown in FIGS. 3A and 3B after bending it into a desired "stack" configuration. A battery 350 (e.g., a 3.7-volt, 13 m-A-hr lithium-ion battery, available from Shenzhen Gerul Battery Co., Ltd., Shenzhen, China) is positioned at a desired location between rigid sections 320 and 330, with battery leads 360 extending along and / or connected to ports on the second rigid section 330. The first rigid section preferably houses the MCU, memory, and RF antenna, and provides some thermal isolation from the more heat-generating second rigid section, as well as separating digital signals from analog signals. The second rigid section preferably houses the power supply, analog sensors, post assembly, and battery (which can be soldered as a post-process after SMD placement). The battery leads are preferably soldered to the castellated edge connections on this section. The first rigid section may also incorporate a castellated edge connection for an SWD debug / programming interface between the MCU and an external debugger / programmer.

[0042] In various embodiments, a miniature transmitter is included on a flexible substrate for connecting wearable sensors, LED sensors, accelerometers, and other sensors to a measurement tracking or control device. The transmitter is preferably located at the edge of the device, preferably outside the artificially created cavity. The transmitter is capable of isolating, amplifying, noise-removing, linearizing, and converting input signals from data sensors and wearable sensors, and transmitting a standardized output signal to a computing / control device. A common electrical output signal range is used.

[0043] As best seen in Figures 3B-3D, the central post 370 preferably extends through an opening in the second rigid section 330 and is secured thereto. In a preferred embodiment, the overall dimensions of the earring device are 12-13 mm in outer diameter, and the dome portion may be formed with a pearlescent appearance or other desired color or style. In various alternative embodiments, the width / diameter of the device may be less than about 16 mm, more preferably less than 12 mm. While the post length is approximately 6-8 mm and the diameter is approximately 1 mm, various design modifications contemplate post lengths of 4.5 mm, 6 mm, 8 mm, and 10 mm, and diameter / post thicknesses of 0.8 mm, 1.2 mm, etc. (and other sizes known in the art). The total weight of the earrings is preferably less than 8 grams each, more preferably less than 5 grams, and they incorporate a comfortable, lightweight design and exterior profile that allows the user to wear the earrings while sleeping.

[0044] 1 and 2, the base component 120 is desirably partially and / or completely contained within the cover 140 (e.g., via preferably seamless outer and inner molding), with the underside of the base positioned adjacent to or in contact with the wearer's skin surface (e.g., the surface of the ear in earring embodiments) when the post is contained within the piercing channel. In various embodiments, the components of the device are desirably fully enclosed and able to withstand complete immersion 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 / water-resistant measures.

[0045] By way of non-limiting example, the cover component may comprise a small, spherical housing, approximately 1 / 4 inch (approximately 6.35 mm) in diameter, containing all the electrical components necessary to operate the wearable sensor and / or biosensor and / or temperature sensor and / or fluid sensor and associated components. Such a design may desirably mimic the profile, shape, and / or color of a small pearl earring or similar design.

[0046] While the disclosed embodiment is a one-piece earring, alternative designs are contemplated, such as an earring device comprised of two parts, e.g., the earring device includes a proximal portion and a distal portion, with the proximal portion having a structure that allows it to be separated from the distal portion. For example, the distal portion may include a small transmitter, other components, and / or at least one wearable sensor, biosensor, or temperature sensor, and the detachable portion of the proximal portion may include a small battery. The proximal portion may be connected to the distal portion by a post (e.g., including a temperature sensor and / or other biosensors, wearable sensors, a microphone, and a speaker), and the proximal portion may have a feature that allows it to be manually slid off the post, similar to an earring clasp. By removing the proximal portion of the device, then inserting the distal portion into the created cavity, and then replacing the proximal portion back into the device and energizing its components, CCT or other biometric measurements can be measured and tracked.

[0047] In various embodiments, as shown in FIG. 1 , the post 130 and / or base 120 may desirably incorporate open and / or transparent portions that allow various components to access the skin surface and / or transmit and receive information from the wearer's anatomy, 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 concentration, and / or CO2 levels. Various types of sensors may be incorporated into the device, including various biochemical sensors (enzyme-based, tissue-based, immunosensors, DNA biosensors, thermal and piezoelectric biosensors), chemical sensors, electromechanical sensors, optical sensors, and / or electrical sensors. For example, these may include chemical sensors for measuring concentration levels of chemicals in blood, sweat, and other bodily fluids, such as blood glucose monitors and lactate meters for diabetics, as well as sensors for measuring proteins, hormones, reproductive hormones, and other chemical constituents (e.g., stress hormones) in sweat. Similarly, electromechanical sensors can be incorporated to track mechanical motion using electrical measurements, such as accelerometers that measure physical activity and device / wearer orientation, inertial measurement units that measure angular change and linear acceleration (e.g., rotational speed and position tracking), and GPS. Optical sensors can be incorporated to detect various biological signals, such as heart rate, heart rate variability, pulse, respiratory rate, oxygen saturation, and blood pressure (as well as temperature, galvanic skin response, and stress sensors). These sensors typically include a light source and a photodiode sensor, and use spectroscopic analysis to measure the amount of light absorbed, reflected, and / or transmitted through adjacent tissue. Electrical sensors (including bioelectrical and electrochemical sensors) may be included to detect, measure, and evaluate electrical signals in the wearer's tissue, including heart rate or brain activity measurements, electrocardiogram information (e.g., ECG or heart rate monitors), EEG measurements (brain waves), electromyogram measurements (EMG or muscle movement monitors), and / or electrode skin sensors to measure sweat levels (e.g., sweat monitoring). Other sensors contemplated herein include pressure sensors, CGM sensors, gyroscopes, GPS receivers, and other wearable sensors.

[0048] In various embodiments, the following measurements and / or sensor combinations are contemplated (including any combination): temperature, pulse, resting heart rate, heart rate variability (HRV), heart rate sensors, perfusion, oxygen levels, blood oxygen levels (SpO2), respiratory rate, blood pressure, glucose, hormones, GPS, accelerometers, motion sensors, ambient and / or cavity microphones and speakers.

[0049] If a measurement or wearable sensor is incorporated into the device (a wearable sensor is a non-limiting example), it is preferably a small, linear or non-linear rod-like structure positioned within and / or on the structure that passes through the artificial cavity created, and the sensor is in electronic communication with a circuit board containing the operating software for the sensor. The wearable sensor is preferably capable of sensing or measuring temperature or temperature changes continuously or periodically, using a specified or unspecified time interval. In a non-limiting example, the sensor functions to accurately detect small temperature changes, on the order of approximately 1 to 0.01 degrees Celsius. The temperature may be measured by a single sensor unit, or multiple sensors may be used.

[0050] As an example of the present disclosure, earring 100 shown in FIG. 1 incorporates multiple wearable sensors, including a temperature sensor disposed within post 130 (e.g., Amphenol Thermometrics SC30F103AN thermistor sensor, St. Marys, Pennsylvania, USA), an ambient temperature sensor disposed within central body 110 (e.g., Murata Electronics North America NTC thermistor NCP03XH103J05RL, Smyrna, Georgia, USA), an accelerometer (e.g., Memsic Semiconductor MC3635 accelerometer, Hsinchu, Taiwan), and an optical sensor package incorporating an optical biosensor with proximity and ambient light sensor functionality (e.g., Renesas Electronics OB1203SD-C4, Tokyo, Japan). Renesas' optical plethysmography (PPG) biosensor integrates a light source and driver, analog-to-digital conversion, and I2C communication into a single optical package. Data from the OB1203 biosensor may be used to measure heart rate (HR), oxygen saturation (SpO2), respiration rate (RR), pulse, or heart rate variability (HRV—an indicator of stress). In various embodiments, the device is capable of measuring one or more of heart rate, heart rate variability, oxygen saturation, respiration rate, a 3-axis accelerometer, earlobe temperature, and / or ambient temperature.

[0051] Figure 4 is a layer-by-layer cross-sectional view of the flexible substrate 310 of Figures 3A and 3B, showing the various layers within the rigid and flexible sections. Figures 5A and 5B show component placement and example placements on the top surface of the first rigid section (Figure 5A) and the bottom surface of the second rigid section (Figure 5B). Figures 6A-6E show pinhole locations in various layers within the flexible substrate, and Figures 7A-7F show mask layers in various layers within the flexible substrate. Figures 8A-8C show circuit diagrams of the example devices of Figures 1 and 2.

[0052] FIG. 9 shows a partial perspective view of an earring post 900 having a hollow interior 910 with an NTC thermistor 920 (or similar measurement sensing device) secured within it. To accommodate the selected thermistor within the post tube, the tube preferably has an inner diameter of 0.8 mm and an outer diameter of approximately 1.1–1.15 mm. This size should provide a comfortable and secure fit within an average earlobe piercing. If desired, a thermally conductive sealant or epoxy 930 can be filled within the tube to seal the ends and optionally secure the thermistor to the interior wall of the post. This arrangement is expected to seal the cavity around the post and allow for good heat transfer from the earlobe to the tube surface.

[0053] The post can be constructed from a variety of materials and / or coatings thereon. Preferred materials include non-allergenic metals (or other materials, including polymers and ceramics) that have sufficient mechanical rigidity to resist bending or crushing during normal use, allow for high thermal conductivity at body temperature, and are suitable for soldering to wires or direct attachment to a PCB. In the disclosed embodiment, stainless steel hypodermic tubing is used as the tubing material, gold-plated for improved solderability and aesthetic appeal. The post assembly has an outer or distal end (e.g., the end that passes through the cavity away from the earring assembly), which is preferably closed and has a smooth finish to facilitate ease and comfort when inserting and passing the post through the earlobe and minimize or prevent the ingress of contaminants. Preferred components include durable, medical-grade materials, including, but not limited to, nickel-free metals, plastics, or 3D-printed resins. Various embodiments of the disclosed devices are preferably durable, impact-resistant, and / or waterproof, making them suitable for long-term use and operation. These materials and electronic components provide strength and performance for continuous use during the wearer's daily activities.

[0054] If desired, the post assembly can be attached to a PCB ground plane by soldering the open end of the tube to a PCB through-hole, which serves as the ground return path for the earring charging circuit.

[0055] The thermistor 920 is preferably located directly on or near the wall of the post, on the portion of the post that extends outside the device and is located within the earring cavity. As shown, the thermistor selected is approximately 0.76 mm in diameter, and thin gauge wires from the sensor preferably extend from the open end of the tube to the PCB for soldering.

[0056] In many cases, it is highly desirable to incorporate multiple different sensor components into a single wearable device. For example, the utility of a temperature-sensing component located within a fabricated cavity is greatly enhanced by incorporating an LED light or photo sensor component in close proximity to the wearer's ear skin surface, such as where the base of the device contacts the ear skin surface. Data obtained from such combined sensing devices is highly useful in data analysis and evaluation, where conclusions drawn from one data stream can be modified or refuted by a second data stream or strengthened by a third data stream. Thus, the present invention contemplates the use of multiple types of sensors in a single device, including the use of a surface sensor in combination with a second, more "invasive" type of sensor, such as a device located within a fabricated cavity. In various embodiments, it may be desirable to incorporate multiple wearable sensor components into individual earring devices, which may include a temperature sensor within the post, as previously described. Preferably, the post sensor is an NTC thermistor type with a fast response time and an RT curve centered in the normal body temperature range (95°F to 102°F), ideally with a tolerance of ±0.1°F. As best shown in Figure 9, the sensor is positioned within the stud-post assembly so that, when worn, the sensor is centered within the earlobe cavity or fits within the thickness of the earlobe cavity (e.g., between the first and second skin layers between the opposing openings of the cavity).

[0057] Because the average earlobe thickness for a typical adult (e.g., North American) is approximately 3-6 mm, the length of the thermistor within the post tube for such individuals is preferably approximately 3-4 mm, measured from the base surface. In some embodiments, the thermistor is preferably positioned within the post assembly just outside the dome and / or base of the earring, thereby positioning the sensor within the earlobe piercing and not protruding from the outside or back of the earlobe during wear.

[0058] During use, the disclosed device is inserted through an artificially created cavity, providing an area for useful wearable sensor and biometric measurements, such as CCT, heart rate, heart rate variability, blood oxygenation, respiratory rate, pulse, glucose, blood pressure, hormones, and at least one temperature measurement among other biosensor measurements. The CCT of the created cavity is preferably measured by partial or complete occlusion of the inter-tissue space with a post and / or wearable sensor and / or temperature sensor. This cavity preferably has an entrance hole, and most typical piercings also have an exit hole (although the device can easily be used with a single blind hole). The created cavity may be linear or non-linear. Non-limiting examples include narrow, non-linear tunnels, similar to those of a belly button piercing. The piercing cavity preferably creates a small, bordered area, approximately 1 mm in radius and 5-8 mm in length, penetrating the wearer's body for CCT and temperature measurements.

[0059] Charging and storage case

[0060] 10A-10C show various views of an example embodiment of a charging and storage case 1000 for an earring device 1010 (or a pair thereof) described herein. The case can be constructed from a variety of materials, including a polycarbonate and / or polyurethane lacquered exterior (similar to the soft-finish clinic white used in current AirPod® devices (sold by Apple Inc., 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 has a shape similar to a jewelry box or earring case. Desirably, the case includes 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-type lid 1030 and a magnetically attached base 1035.

[0061] 10D and 10E show diagrams of one embodiment of a charging and storage case for earring devices, which opens to reveal a left earring well 1040a, a right earring well 1050a, and one or more auxiliary wells 1060a or recesses for clasps, backings, or other fastening devices. The left and right earring wells 1040a and 1050a each have a central opening 1070a designed to accommodate a corresponding earring post for securing and charging the earring when placed in the case. A pair of LED indicators 1080a are provided to indicate the charging state and / or charging status of each earring. Similar charging status or other indicators 1090a are also provided on the exterior surface of the case, allowing the user to view charging information for the earrings without opening the lid. In the disclosed embodiment, the LED lights may turn off or change color when the earrings are fully charged. By way of example, the battery charge rate, life, or duration may be displayed on or within the charging case. In other examples, the percentage of battery life may also be transmitted to and displayed by remote software and / or an app.

[0062] In at least one exemplary embodiment, the storage case incorporates four LEDs, each indicating the following: D1 indicates the charging status of the charging base's internal battery; D3 indicates whether the battery in the charging base has power (i.e., the earrings can be charged without the case being plugged into a wall outlet); D4 and D5 are LEDs that indicate the charging status of each earring; and the charging case incorporates a reset button that performs a reset in the "power on" state. If desired, the D4 and D5 components can be substituted to perform a power-on reset of the earrings in the event of an MCU hang or system reboot. In the current embodiment, the third and fourth LEDs are used to individually indicate the charging status of each earring.

[0063] In various embodiments, the earring device is "fast charging" and preferably can be charged from 85% to full (from a completely dead or "low battery" state) within two hours of charging. More preferably, the earring device is "fast charging" and preferably can be charged from 85% to full (from a completely dead state) within 20 to 30 minutes, or within 10 minutes of charging.

[0064] In one embodiment, the case may incorporate one or more of the following features:

[0065] Safely charges two earring devices simultaneously or one earring individually (e.g., when the other earring is worn). Includes the ability to charge individual earrings at different rates (e.g., fast charge one earring and trickle or maintenance charge the other).

[0066] The case contains a rechargeable backup battery that powers the charger (and charges the earrings) when the case is not connected to an external power source.

[0067] It is equipped with a USB Type-C power port and charge controller circuitry for charging the internal backup battery or for directly charging the earrings.

[0068] Including various internally and / or externally visible LED status indicators (e.g., individual earring charging status, charging power ready, internal backup battery charging status, linked device status, etc.) and alerts such as vibration, sound, and / or light notifications.

[0069] A hinged cover lid is incorporated (optionally including a magnetically attached hinged cover).

[0070] This includes spaces such as recesses or holes for earring clasps and backings.

[0071] Wireless communication and device link

[0072] In various embodiments, the disclosed devices utilize wireless communication methods, such as Bluetooth®, to transmit data (e.g., real-time data and / or stored data—including two-way data transmission) with minimal power usage between the earring device and a computing service, such as the wearer's smart device, smartphone, and / or other computing device / antenna system. Such wireless communication includes Bluetooth® transmit and receive capabilities (e.g., Bluetooth Low Energy® or BLE) at distances of up to 50 feet (approximately 15.24 meters), although additional wireless communication methods, such as Wi-Fi and cellular connections, are also contemplated. Additionally, the use of "airplane mode" and / or power-restricted modes is also contemplated herein.

[0073] An important feature of the present invention is the ability of the earring device to link to one or more devices, such as a mobile phone carried by the wearer or a computing system accessible to the wearer. Preferably, the earring device incorporates a low-power wireless communication device, such as a Bluetooth® BLE 5 communication component, that can transmit / pair / link with a mobile or stationary computing device and provide data obtained from the earring device to the mobile / stationary computing device. In preferred embodiments, the mobile / stationary computing device includes a program or computing application (e.g., APP) that receives, stores, and analyzes data from the earring device and provides various health indicators and status to the wearer of the earring and / or other individuals regarding the wearer's health. In various embodiments, the earring device's ability to receive data via Bluetooth® or other communication systems allows for desired modification of the earring's functionality and performance.

[0074] In some embodiments, data logging and / or storage capabilities may be incorporated into the earring device, particularly for times when real-time data transmission to the computing device is not possible (i.e., when the user's smart device is out of BLE range or in airplane mode).

[0075] In various embodiments, the device is preferably EMF (electromagnetic field) safe or has the ability to enter an EMF safe mode (which may be automated or user controlled using an associated APP), and while in such a mode, the device preferably continues to collect and / or log data as directed by the user for future transmission / download to an application.

[0076] Application Programming

[0077] 11A through 11D illustrate various graphical user interface (GUI) displays for embodiments of an application program (APP) loaded onto a mobile phone (e.g., a Samsung S22+ mobile phone sold by Samsung Electronics Co., Ltd., Americas). In these embodiments, data received from the wearer's sensing device is transmitted to the wearer's mobile phone, where the application program (APP) receives and analyzes the data and provides a summary of the processed data to the wearer. Much of the underlying data collection is preferably performed without the wearer's active intervention, but rather is automated to a large extent. In addition to displaying processed and raw data, the various GUIs provide "interpretations" of the wearer's health and wellness status, such as the wearer's fertility ( FIG. 11A ), core body temperature ( FIG. 11B ), and / or menstrual cycle history ( FIGS. 11C and 11D ).

[0078] For example, the disclosed system components enable users to: (1) monitor key menstrual cycle metrics along with stress, activity, and sleep; (2) receive personalized insights and actionable feedback based on their unique metrics; (3) gain insights into fertility, menstrual cycle, and overall health; (4) track menstrual cycle phases and enable users to adjust their lifestyle accordingly; (5) identify monthly fertile windows to manage reproductive health; (6) track stressful periods to help users build resilience against daily life challenges; (7) discover activity data and trends to maximize wearer performance and results; and (8) identify habits and routines for optimal health, wellness, and sleep for the wearer.

[0079] The program application resides on a computing device and preferably receives and records biodata (i.e., CCT temperature, ambient temperature, heart rate, HRV, pulse, respiration rate, blood oxygen level, and triaxial accelerometer) via Bluetooth® technology through the earring. The app's coding measures how this correlates with known physiology by graphing each night's sleep temperature measurements over time and evaluating the presence of a visually discernible minimum temperature in more than 50% of the waveforms. The date of ovulation is then calculated using the in-piercing measurements and controlled against the wearer's artificial intelligence (AI). The cosinor law is used for coding and mathematical calculations. The app may reside on a mobile phone or other similar device capable of receiving and / or monitoring Bluetooth® communications from the earring. While various embodiments allow for the use of a single earring, two earrings may be preferred to detect and respond to temperature fluctuations (e.g., when the wearer sleeps on their side, when the earring falls off, when one side of the wearer is facing a fan, etc.).

[0080] FIG. 12 illustrates a non-limiting flowchart of data processing of CCT measurements or values applied by an application. Once a temperature is sensed, it is transmitted and then wirelessly recorded by the receiver. The receiver records the CCT value and records it in a format that preserves which sensor device transmitted the CCT value (used to distinguish between different devices when multiple devices are used simultaneously) and the time. Two or more wearable sensors and / or temperature sensors can be used in a single body, each with a cavity created in it. When multiple wearable sensors and / or temperature sensors are used simultaneously, the receiver can obtain all temperature measurements. These temperatures are compared, and an algorithm is applied to calculate a single temperature value at that time. For example, as a non-limiting example, one sensor can be used in the left ear and another in the right ear. In a non-limiting example, when the receiver obtains both temperature measurements, the lowest temperature value is selected and used for further calculations.

[0081] In some embodiments, recorded temperature values are plotted against time, and an algorithm is applied to determine local and global minimum and maximum values. Additionally, the global minimum for a given period can be plotted against successive time periods. For example, and without limitation, the minimum CCT for one night can be used and implemented across many nights. By applying an algorithm to plot the CCT for multiple nights, quantified patterns can be determined, revealing ovulation trends. This allows for the determination or prediction of physiological outcomes and / or conditions based on conclusions drawn from ovulation patterns.

[0082] A main algorithm is used to determine local and global minimum and maximum values, although any of a variety of algorithms may be used, including, but not limited to, algorithms for calculating IBT or BBT by measuring CCT to aid in determining fertility.

[0083] FIG. 13 visually illustrates how temperature measurements can be plotted against time to aid in determining ovulation. One method known to those skilled in the art to determine when ovulation occurs is to track the rise in body temperature during a woman's menstrual cycle, which occurs suddenly at the time of ovulation. This rise in body temperature is caused by progesterone secreted during the second half of the cycle, raising body temperature by approximately 0.5 degrees Fahrenheit (0.27-0.28 degrees Celsius). During the first half of the menstrual cycle, body temperature fluctuates between approximately 97.2°F (36.22°C) and 98.0°F (36.66°C). Over the next one to two days, the temperature rises sharply by more than 0.5°F, reaching 98.2°F (36.77°C) and 99.0°F (37.22°C). This elevated temperature is maintained until the next menstrual period. Using this information, it can be determined that ovulation occurs, on average, one to two days before the sudden rise in body temperature. This slight change in body temperature requires a temperature sensor that can accurately detect changes as small as 0.1°F to 0.01°F.

[0084] Artificial Intelligence (AI) Processing

[0085] In various embodiments, the biometric data measured from the earrings can be processed using an artificial intelligence module, which preferably mines the temperature data (as well as other data received from the device and other information acquired by the AI regarding the wearer's activities or daily life data). The AI module preferably correlates and compares previous CCTs with other data to identify relationships and trends between data sets, such as increases in body temperature during exercise (which can temporarily induce an artificial increase in body temperature that mimics the increase in body temperature during ovulation) and similar indicators. Preferably, the AI module is designed to have access to data about the wearer beyond that transmitted by the earrings. Furthermore, 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. This may reduce false positives and negatives, as well as improve the sensitivity and accuracy of the data presented by the application and facilitate early detection of early symptoms and diseases.

[0086] The disclosed device is easily worn as easily as wearing earrings, and data is preferably transmitted to an application on the wearer's mobile phone or to a software platform for remote patient monitoring, healthcare, clinical monitoring, and notifications. The wearable sensor is small and compact, designed to be worn continuously during normal daily or nighttime activities. Due to its size, comfort, ease of use, and lack of manual operation, the wearer does not need to interrupt their daily activities or wake up while the device is reading the wearer's CCT and other metrics. Furthermore, CCT information and / or other metrics can be wirelessly transmitted to an external processor or memory device for tracking temperature and / or other metrics.

[0087] In addition to collecting, analyzing, storing, and displaying user data, it is desirable for the application to include additional functionality to ensure the ability to update and / or improve the performance of the earring device, such as the ability to automatically update firmware via the data application. Similarly, it is highly desirable for the application to provide push notifications for software updates and the ability to incorporate improvements to the device, such as the ability to add HRV, oxygen, accelerometers, and other health measurements to existing earring designs, via software updates or additional components / upgrades.

[0088] Achieving smart fastenings / backings

[0089] FIG. 14 illustrates an alternative embodiment of the disclosed wearable device, which can be used as a clasp, backing, or similar attachment device for multiple earrings, including earrings that the wearer may already own prior to obtaining and / or using the disclosed device. In this embodiment, wearable sensing device 1400 is comprised of a central body 1410 with associated electronic components (and optional coverings) similar to those described above, but includes a post or sleeve 1420 with an opening 1425 formed therein. This post or sleeve is desirably capable of engaging and securing a standard or ordinary earring post, typically having a diameter of 21-18 gauge (or approximately 0.71 mm-1.0 mm, or approximately 0.028 inches-0.040 inches). If desired, the sleeve may be constructed of a rigid structure or a relatively flexible / expandable material to accommodate and / or secure multiple earring post gauges. Desirably, device 1400 includes at least one sensor, biochemical sensor, electrical sensor, electrochemical sensor, electromechanical sensor, electrode, optical sensor, and / or temperature sensor or thermistor 1430 in the exposed portion of sleeve 1420. Optionally, in one embodiment, device 1400 further includes at least one sensor, biochemical sensor, electrical sensor, electrochemical sensor, electromechanical sensor, electrode, and / or optical sensor 1450 in the exposed portion of base 1440. Sensors include, but are not limited to, accelerometers, optical sensors, biochemical sensors, bioelectrical sensors, electrochemical sensors, pressure sensors, CGM sensors, gyroscopes, GPS and other wearable sensors, LED sensors to measure heart rate, HRV, respiration rate, blood oxygenation, pulse, accelerometers to measure movement, activity, calories burned, distance traveled, and steps, LED and pressure sensors to measure blood pressure, CGM sensors for blood glucose monitoring, gyroscopes to measure angular velocity, Global Positioning System (GPS), magnetometers to measure magnetic fields, electrochemical sensors for hormone and other biosensors, speakers and / or microphones for music and phone calls.

[0090] As clearly depicted in FIGS. 15A-15C, the disclosed backing sensor device 1400 may be compatible with or utilized with various earring shapes and / or types (FIG. 15A). The backing sensor device may be placed over the earring post like a sleeve or jacket, or may surround the earring post (see FIG. 15B). The sleeve is then moved over the post, and the sleeve and sensor are inserted from the back of the ear (depicted as the first skin wall 1510 and the second skin wall 1520 of the ear) into the formed cavity (depicted as the first skin wall 1510 and the second skin wall 1520 of the ear) (preferably thin enough that the sleeve and sensor can slip between the post and the cavity wall during use) (see FIG. 15C). This allows accurate acquisition of the temperature of the formed cavity and other biosensor measurements described above. Similarly, the central body base 1440 may include additional sensor components, lights, etc. (and openings and / or transparency for accommodating such components), as previously described, to enable measurement and assessment of various wearer characteristics as described herein.

[0091] It should be understood that this alternative embodiment may include the components and functionality described above, as well as application software for interfacing with the charging case components and computing device. In this manner, a wearer may wear earrings with different designs and may switch designs daily or more frequently without interfering with the data collection and analysis described herein.

[0092] If desired, the fastening device may be configured to work with other types of earring posts, including posts, push-back studs, screw posts, hinge hoops, latch-backs, levers, springs, huggies, French clips, and / or other fastening types known to those skilled in the art.

[0093] equivalent

[0094] While the subject matter of the present invention has been described in detail with reference to specific embodiments thereof, it will be understood that those skilled in the art, upon understanding the foregoing, may readily make alterations, variations, and equivalents to such embodiments. Accordingly, the scope of the present disclosure is illustrative rather than limiting, and the present disclosure does not exclude the inclusion of modifications, variations, and / or additions to the subject matter as would be readily apparent to one skilled in the art.

[0095] Thus, while exemplary embodiments of the present invention have been shown and described, it is to be understood that all terms used herein are descriptive and not limiting, and that many changes, modifications, and substitutions are possible by those skilled in the art without departing from the spirit and scope of the invention.

[0096] All references cited herein, including publications, patent applications, and patents, are hereby incorporated by reference in their entireties to the same extent as if each reference was individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

[0097] The various headings and titles used herein are for the convenience of the reader and should not be construed as limiting or restricting the features and disclosure that follow to any particular embodiment. It is understood that various exemplary embodiments may incorporate numerous combinations of the various advantages and / or features described, all of which combinations are contemplated and expressly incorporated herein.

[0098] In the context of describing the present invention, the use of the terms "a," "an," and "the" and similar referents are intended to include both the singular and the plural, unless otherwise stated herein or clearly contradicted by context. The terms "comprising," "having," "including," and "containing" are to be construed as open-ended terms (i.e., meaning "including, but not limited to"), unless otherwise indicated. The recitation of ranges of values herein is intended to serve as a shorthand method of individually referring to each separate value falling within the range, unless otherwise stated herein, and each separate value is incorporated into the specification as if it were individually set forth herein. All methods described herein can be performed in any suitable order, unless otherwise stated herein or clearly contradicted by context. Any examples provided herein, or the use of exemplary language (e.g., "such as"), are intended only to better illustrate the invention and do not pose limitations on the scope of the invention unless specifically claimed. No non-claimed element in the description herein should be construed as essential to the practice of the invention.

[0099] Preferred embodiments of the invention are described herein, including the best mode known to the inventors for carrying out the invention. Variations of these preferred embodiments will become apparent to those skilled in the art upon reading the foregoing description. The inventors expect skilled artisans to adopt such variations as necessary, and the inventors intend the invention to be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, this invention includes any combination of all possible variations of the above-described elements unless otherwise indicated herein or clearly contradicted by context.

Claims

1. A device for continuously monitoring the physiological state of a wearer, the device having an artificially created cavity in living tissue, comprising: the cavity is defined by a first hole provided in the body tissue and a second hole provided at a position opposite the first hole; The device comprises: a central body having a first sensor component disposed outside the artificially created cavity near the surface of the wearer's skin and configured to continuously or periodically provide a first signal of a first measurement value of a first physiological condition of the wearer at specified time intervals; a body piercing device post designed for insertion into and fitted to the artificially created cavity, the body piercing device post having dimensions for insertion through at least one first hole in the biological tissue into the artificially created cavity, the body piercing device post having a second sensor component disposed within the artificially created biological tissue cavity, the second sensor component providing a second signal of a second measurement value of a second physiological condition of the wearer continuously or periodically at specified time intervals; a transmitter configured to continuously or periodically wirelessly transmit the first and second measurements for recording, the transmitter being disposed within the central body so that in use it is located outside the artificially created cavity; The device further includes at least one power source that provides power to the first sensor, the second sensor, and the transmitter.

2. The device of claim 1 , wherein the first sensor measures the wearer's blood oxygen level and the second sensor measures the wearer's body temperature.

3. The device of claim 1 , wherein the first sensor measures the wearer's blood pressure and the second sensor measures the wearer's body temperature.

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

5. The device of claim 1 , wherein the sensor is removable by the wearer.

6. A device for continuously monitoring the physiological state of a wearer, the device having an artificially created cavity in living tissue, comprising: the cavity is defined by a first hole provided in the body tissue and a second hole provided at a position opposite the first hole; The device comprises: a central body having a first sensor component disposed outside the artificially created cavity near the surface of the wearer's skin and configured to continuously or periodically provide a first signal of a first measurement value of a first physiological condition of the wearer at specified time intervals; a sleeved tube for receiving a body piercing device post extending through the artificially created cavity, the sleeved tube including an extension that substantially surrounds the body piercing device post and enters the artificially created cavity, the extension having a second sensor component disposed within the artificially created cavity of the living tissue and that provides a second signal of a second measurement of a second physiological condition of the wearer continuously or periodically at specified time intervals; a transmitter configured to continuously or periodically wirelessly transmit the first and second measurements for recording, the transmitter being disposed within the central body so that in use it is located outside the artificially created cavity; The device further includes at least one power source that provides power to the first sensor, the second sensor, and the transmitter.

7. The device of claim 6 , wherein the first sensor measures the wearer's blood oxygen level and the second sensor measures the wearer's body temperature.

8. The device of claim 6 , wherein the first sensor measures the wearer's blood pressure and the second sensor measures the wearer's body temperature.

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

10. The device of claim 6 , wherein the sensor is removable by the wearer.

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