WO2024252422A1

WO2024252422A1 - A wearable device to treat menopausal hot flashes

Info

Publication number: WO2024252422A1
Application number: PCT/IN2024/050698
Authority: WO
Inventors: Nitya DINTAKURTI; Balaji Teegala; Prashant Jha
Original assignee: Ru Medical Private Ltd
Current assignee: Ru Medical Private Ltd
Priority date: 2023-06-09
Filing date: 2024-06-07
Publication date: 2024-12-12
Anticipated expiration: 2025-12-09

Abstract

A wearable device to treat menopausal hot flashes configured to be placed in contact with a user's skin The wearable device comprises a cooling plate, a skin temperature sensor configured for measuring temperature of the user's skin, a Peltier cooling module in contact with said cooling plate, a controller functionally connected to the skin temperature sensor and the Peltier cooling module, where the controller is configured to measure a temperature of the user's skin using the skin temperature sensor, determine if the measured temperature is beyond a threshold temperature value, activate the Peltier cooling module for a specified time period if the measured temperature is beyond said threshold temperature value.

Description

A WEARABLE DEVICE TO TREAT MENOPAUSAL HOT FLASHES

TECHNICAL FIELD OF INVENTION

The present invention generally relates to wearable medical devices. More particularly, the present invention relates to a wearable device to treat menopausal hot flashes. The present invention can also be applicable for thermoregulation applications in other commercial and industrial settings.

BACKGROUND OF THE INVENTION

Menopause is signalled by 12 months since last menstruation, caused due to a decline in reproductive hormones in a female body. One of the most common symptoms of the menopause is Hot Flashes. Most women nearing menopause will have hot flashes, sudden feelings of warmth that spread over the upper body, often with flushing and sweating. These flashes can range from mild in most women to severe in others. These flashes experienced by menopausal women can significantly impact their quality of life. These flashes can interfere with daily activities, disrupt sleep, and cause anxiety and depression. They can also have a negative impact on work and social life, as women may be reluctant to participate in activities that could trigger a hot flash or be embarrassed if one occurs in public.

The Menopause is defined as a full 12 months without menstrual bleeding, in the absence of any surgery or medical condition that may cause bleeding to artificially stop. As menopause nears, the level of estrogen in the body drops. When this decrease occurs, a menopausal woman can experience a wide variety of symptoms. Hot flashes are one of the most frequent symptoms of menopause. There’s no definitive reason why they happen, but there are multiple false triggers in the thermoregulatory system of the human body causing body temperature to rise sharply to cause sudden sensations of intense heat. The body then tries to cool down by pumping blood to the periphery of the body to cool it by convection using proximity to atmospheric air causing a red, flushed face, sweating, an increase in heart rate and sometimes a chilled feeling after the heat. They are usually felt in the upper body, most intensely over the face, neck, and chest. Currently, the most common treatment for Hot Flashes is Hormone Replacement Therapy (HRT), which is not very popular amongst healthcare professionals and patients. It has been shown that prolonged use of HRT can cause increased risks of heart disease, breast cancer, stroke, etc.

The human body has a thermoregulatory system, controlled by the hypothalamus. When the body’s internal temperature changes, sensors in the central nervous system (CNS) send a message to the hypothalamus, which responds by sending signals to different organs and systems in the body. If the body needs to cool down, these signals can be sent to sweat glands to produce excess sweating. The skin plays a significant role in regulating the core temperature of the human body. The human body has certain regions that have a high density of thermoreceptors. A thermoreceptor is a non- specialized sense receptor that codes absolute and relative changes in temperature, primarily within the innocuous range. The head, neck, and face are regions of high thermosensitivity, and cooling the neck has been shown to alleviate heat strain more effectively. The neck is in closer proximity to the hypothalamus than other areas with high density of thermoreceptors. Additionally, since Hot Flashes are felt most intensely over the face and neck region, one embodiment of our device is designed for placement on the back of the neck, a highly effective location for treatment.

There are several devices available to help menopausal women manage their hot flashes. These devices are designed to help regulate body temperature and provide relief from the discomfort and disruption caused by the hot flashes. One popular device is the cooling scarf. These scarves are made from a special material that stays cool when wet. Another option is the cooling pillow. These pillows are designed to stay cool all night, providing women with relief from night sweats and hot flashes that can disrupt their sleep. There are also wearable devices such as cooling vests and wristbands. These devices are designed to be worn underneath clothing and use a combination of cooling technology and moisture-wicking fabrics to help regulate body temperature. In addition to these devices, there are also apps available that can help women track and manage their hot flashes. These apps allow women to record the frequency and intensity of their hot flashes, as well as any triggers that may be causing them. They can also provide tips and recommendations for managing hot flashes, such as breathing exercises or relaxation techniques.

One example of a prior-art device is disclosed in US20100185267A1, which describes a device that uses cold plates and a Peltier effect device that is moved back and forth across the back of the neck to stimulate cold thermoreceptors in the skin in order to provide relief. However, US20100185267A1 does not disclose any method or means to automatically detect the onset of a Hot Flash. Hot Flashes typically last anywhere between a few seconds to 5 minutes. Automatic detection would allow for a more efficient and quicker relief mechanism.

Another example of a prior-art device is disclosed in US20180064574A1, which describes a temperature regulating device, for a user's neck, that includes a housing that extends about the sides of the neck. It is bulky and very difficult to cover up due to its large size. Similarly, US20180064574A1 requires manual activation which would be too late to provide relief from hot flashes.

However, these devices do have shortcomings, and some key challenges yet to be addressed in menopausal women suffering from hot flashes to provide relief are timely intervention & effective body temperature regulation.

Therefore, there is a continued need for better technologies to accurately predict and reset a menopausal hot flash.

OBJECTIVES OF THE INVENTION:

A basic object of the present invention is to overcome the disadvantages and drawbacks of the known art.

An objective of this invention is to provide a wearable device to treat menopausal hot flashes.

Another objective of this invention is to provide a flexible wearable device with flexible components to add to the comfort of the wearer. Another objective of this invention is to trigger the thermoreceptors in an identified part of the human body to regulate body temperature in order to provide relief.

Another objective of the invention is to improve skin sensitivity at the location of cooling.

Another objective of the invention is to detect contact of device with skin across the entire surface at the location of cooling.

Another objective of the invention is the detect temperature of skin across the entire surface at the location of cooling.

Yet another object of the invention is to provide holistic support and information by means of device connectivity with mobile computing devices, showcasing clinician approved information, and a community for menopausal women.

SUMMARY OF THE INVENTION:

The following presents a simplified summary of the invention in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the present invention. It is not intended to identify the key/critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some concept of the invention in a simplified form as a prelude to a more detailed description of the invention presented later.

Aspects of the present invention relate to a wearable device to treat menopausal hot flashes configured to be placed in contact with a user’s skin, the wearable device comprises a cooling plate, a skin temperature sensor configured for measuring temperature of the user’s skin, a Peltier cooling module in contact with said cooling plate, a controller functionally connected to the skin temperature sensor and the Peltier cooling module, where the controller is configured to measure a temperature of the user’s skin using the skin temperature sensor, determine if the measured temperature is beyond a threshold temperature value, activate the Peltier cooling module for a specified time period if the measured temperature is beyond said threshold temperature value.

According to some aspects, the threshold temperature value of the measured temperature is in the range of 36.1 °C and 37.7 °C

According to some aspects, the Peltier cooling module is activated for a specified time period ranging between 10-60 seconds.

According to some aspects, the wearable device comprises an ambient temperature sensor configured for measuring an ambient temperature, wherein the controller measures the ambient temperature using the ambient temperature sensor, and determines said threshold temperature value using the ambient temperature sensor.

According to some aspects, the wearable device comprises a bioimpedance sensor in contact with said cooling plate, wherein the bioimpedance sensor is configured to measure impedance of skin tissue that is in contact with the cooling plate, wherein the controller is configured to determine that the wearable device is in contact with the user’s skin by measuring the bioimpedance of the skin tissue.

According to some aspects, the controller measures the impedance of the cooling plate to determine if the cooling plate is in contact with the user’s skin.

According to some aspects, the wearable device comprises a heart rate sensor configured to measure heart rate of the user, and wherein the controller measures the heart rate of the user using the heart rate sensor and is configured to determine the onset of a hot flash based on the measurement of the heart rate sensor.

According to some aspects, the controller comprises a machine learning module. According to some further aspects, the wearable device comprises an ambient temperature sensor, a bioimpedance sensor, and a heart rate sensor, wherein the controller uses the machine learning module to determine onset of a hot flash using data measured from the skin temperature sensor, the ambient temperature sensor, the bioimpedance sensor, and the heart rate sensor. According to some further aspects, the controller automatically activates the Peltier cooling module if it determines onset of the hot flash. According to some further aspects, the controller automatically modulates the cooling intensity of the Peltier cooling module. According to some further aspects, the controller automatically halts the operation of Peltier cooling module.

According to some aspects, the wearable device is configured to communicate with a user device using a communication module. According to some further aspects, the wearable device is configured to receive a control signal from the user device to activate the Peltier cooling module. According to some further aspects, the wearable device is configured to receive a control signal from the user device to modulate the cooling intensity of the Peltier cooling module. According to some further aspects, the wearable device is configured to receive a control signal from the user device to halt the operation of the Peltier cooling module. According to some further aspects, the wearable device is configured to receive a control signal from the user device to modulate the time period of activation of the Peltier cooling module. According to some further aspects, the wearable device is configured to receive a control signal from the user device to change the threshold temperature value of the measured temperature. According to some further aspects, the wearable device is configured to receive a control signal from the user device to change the specified time period of activation of the Peltier cooling module. According to some further aspects, the controller uses machine learning to control the time period of activation of the Peltier cooling module based on control signals received from the user device over a period of time. According to some further aspects, the controller uses machine learning to control the cooling intensity of the Peltier cooling module based on control signals received from the user device over a period of time.

According to some aspects, controller monitors the temperature measurement of the skin temperature sensor over the specified period of time to determine the activation state of the Peltier cooling module. According to some further aspects, the controller monitors the time duration of the activation state of the Peltier cooling module to determine the time period of delivery of treatment.

According to some aspects, the wearable device is configured in the shape of a neck band.

According to some aspects, the wearable device is configured in the shape of a wrist band.

According to some aspects, the wearable device is configured in the shape of a pendant.

According to some aspects, the wearable device is secured to a user’s body using an adhesive patch attached to the wearable device.

According to some aspects, the bioimpedance sensor comprises a pair of electrodes, and the electrodes of the bioimpedance sensor are configured to deliver microcurrent therapy to the user’s skin.

According to some aspects, the wearable device is a flexible wearable device.

According to some aspects, the wearable device comprises a flexible polymer body.

According to some aspects, the wearable device comprises a combination of flex electronics via a flex printed circuit board (PCB) or rigid-flex PCB.

According to some aspects, the wearable device comprises a flexible battery.

According to some aspects, the wearable device comprises a flexible heat sink.

According to some aspects, the wearable device comprises a charging module configured to charge a rechargeable battery for powering the wearable device.

According to some aspects, the wearable device comprises a button for turning the wearable device on or off. According to some aspects, the wearable device comprises an audio speaker configured to provide an auditory alert to the user.

According to some aspects, the wearable device comprises an LED light configured to provide a visible alert to the user.

According to some aspects, the cooling plate comprises a first metal plate, a second metal plate, and a metal oxide strip between the first metal plate and the second metal plate, where the metal oxide strip acts as a thermistor with known resistance values at various temperatures, and where the first metal plate and the second metal plate act as a pair of electrodes configured to provide microcurrent therapy to the user’s skin.

According to some further aspects, a first lead connects the first metal plate to the internal circuit of the wearable device, and a second lead connects the second metal plate to the internal circuit of the wearable device.

According to some aspects, the cooling plate comprises a matrix comprising a first set of miniature metal plates connected to each other, and a second set of miniature metal plates connected to each other, where the first set of miniature metal plates are electrically isolated from the second set of miniature metal plates. According to some further aspects, a first lead connects the first set of miniature metal plates to the internal circuit of the wearable device, and a second lead connects the second set of miniature metal plate to the internal circuit of the wearable device.

Some other aspects of the present invention relate to a wearable device to treat menopausal hot flashes configured to be placed in contact with a user’s skin. The wearable device comprises a cooling plate; a skin temperature sensor configured for measuring temperature of a user’s skin; a Peltier cooling module in contact with said cooling plate; a controller functionally connected to the skin temperature sensor and Peltier cooling module, wherein the controller is configured to measure a temperature of the user’s skin using the skin temperature sensor; determine if the measured temperature is beyond a threshold temperature value; activate the Peltier cooling module for a specified time period if the measured temperature is beyond said threshold temperature value, wherein the wearable device comprises a bioimpedance sensor, wherein the bioimpedance sensor comprises a pair of electrodes, and wherein the electrodes of the bioimpedance sensor are configured to deliver microcurrent therapy to the user’s skin.

Some other aspects of the present invention relate to a flexible wearable device to treat menopausal hot flashes configured to be placed in contact with a user’s skin, the wearable device comprising a cooling plate; a skin temperature sensor configured for measuring temperature of a user’s skin; a Peltier cooling module in contact with said cooling plate; a controller functionally connected to the skin temperature sensor and Peltier cooling module, wherein the controller is configured to: measure a temperature of the user’s skin using the skin temperature sensor; determine if the measured temperature is beyond a threshold temperature value; activate the Peltier cooling module for a specified time period if the measured temperature is beyond said threshold temperature value, wherein the wearable device comprises a flexible heat sink.

According to some aspects, the flexible heat sink is in the form of braided copper.

Other aspects, advantages, and salient features of the invention will become apparent to those skilled in the art from the following detailed description, which, taken in conjunction with the annexed drawings, discloses exemplary embodiments of the invention.

BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS:

Some of the objects of the invention have been set forth above. These and other objects, features, aspects and advantages of the present invention will become better understood with regard to the following description, appended claims and accompanying drawings where:

FIGS. 1A-1H are schematic illustrations of an embodiment of a wearable device of the present application, where FIGS.1A-1E illustrates the embodiment of the wearable device, and FIGS. 1F-1H illustrates different embodiments of the cooling plate that can be incorporated in the embodiment of the wearable device of FIGS. 1A- 1E.

FIG. 2 is a flow chart illustrating an exemplary method of operation of the embodiment of the wearable device of FIGS. 1A-1E.

FIG. 3 is a schematic illustration of a second embodiment of the wearable device of the present application.

FIG. 4 is a schematic illustration of a third embodiment of the wearable device of the present application.

FIG. 5 is a schematic illustration of a fourth embodiment of the wearable device of the present application.

Corresponding reference numerals indicate corresponding parts throughout the drawings.

DETAILED DESCRIPTION OF INVENTION:

The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention. Although examples of construction, dimensions, and materials are illustrated for the various elements, those skilled in the art will recognize that many of the examples provided have suitable alternatives that may be utilized.

Overview

The present invention relates to a cooling or heating therapy device that can be used on thermoregulatory hotspots of the human body. The areas of the human body that are heavily concentrated with thermoregulatory hotspots are the head, neck, chest, and back. These areas contain a high density of thermoreceptors and blood vessels that allow for efficient regulation of body temperature. These receptors allow for rapid detection of changes in external temperature and provide feedback to the hypothalamus to initiate appropriate responses to regulate body temperature. Hot flashes are a result of an error in this feedback mechanism creating sudden and intense sensations of heat. The present invention resets this feedback mechanism by providing cooling sensation when placed at any of the thermoregulatory hotspots and provides relief from the hot flash. The duration of a hot flash event in menopausal women can vary widely, but typically lasts between 30 seconds to several minutes during which time, the body temperature can rise by approximately 0.5 to 1.5 degree Celsius. The present invention detects the onset of a hot flash by monitoring the rise of body temperature of the user. The temperature sensitivity of the skin can be improved by microcurrent therapies and can increase the perception of the skin to temperature changes. The present invention provides localized micro-current therapy in order to sensitize the skin to temperature changes reducing the cooling temperature required for cooling in order to provide a higher cooling sensation and provide relief from the hot flash. Menopausal women experience hot flashes differently with variations in a) duration of hot flash event, b) body temperature profiles before, during, and after a hot flash event, and c) skin sensitivity to cooling sensation. The present invention comprises a machine learning model that builds on a baseline and improves itself as it gathers data of each hot flash event of the user to provide a more personalized cooling sensation. It is very important that the device be in contact with the surface of the skin to ensure that the cooling sensation is properly transmitted to the skin surface. The present invention comprises an impedance measurement module that can assess if the device is in contact with skin or not. This can be used to provide cooling sensation only when the device is in contact with the skin or to raise an alert to inform the user regarding improper or no contact.

Embodiments of the present invention disclose a wearable device to treat menopausal hot flashes configured to be placed in contact with a user’s skin, the wearable device comprises a cooling plate, a skin temperature sensor configured for measuring temperature of the user’s skin, a Peltier cooling module in contact with said cooling plate, a controller functionally connected to the skin temperature sensor and the Peltier cooling module, where the controller is configured to measure a temperature of the user’s skin using the skin temperature sensor, determine if the measured temperature is beyond a threshold temperature value, activate the Peltier cooling module for a specified time period if the measured temperature is beyond said threshold temperature value.

In some embodiments, the threshold temperature value of the measured temperature is in the range of 36.1 °C and 37.7 °C

In some embodiments, the Peltier cooling module is activated for a specified time period ranging between 10-60 seconds.

In some embodiments, the wearable device comprises an ambient temperature sensor configured for measuring an ambient temperature, where the controller measures the ambient temperature using the ambient temperature sensor, and determines said threshold temperature value using the ambient temperature sensor.

In some embodiments, the wearable device comprises a bioimpedance sensor in contact with said cooling plate, where the bioimpedance sensor is configured to measure impedance of skin tissue that is in contact with the cooling plate, where the controller is configured to determine that the wearable device is in contact with the user’s skin by measuring the bioimpedance of the skin tissue. In some further embodiments, the electrodes of the bioimpedance sensor are configured to deliver microcurrent therapy to the user’s skin.

In some embodiments, the controller measures the impedance of the cooling plate to determine if the cooling plate is in contact with the user’s skin.

In some embodiments, the wearable device comprises a heart rate sensor configured to measure heart rate of the user, and where the controller measures the heart rate of the user using the heart rate sensor and is configured to determine the onset of a hot flash based on the measurement of the heart rate sensor.

In some embodiments, the controller comprises a machine learning module. In some further embodiments, the wearable device comprises an ambient temperature sensor, a bioimpedance sensor, and a heart rate sensor, where the controller uses the machine learning module to determine onset of a hot flash using data measured from the skin temperature sensor, the ambient temperature sensor, the bioimpedance sensor, and the heart rate sensor. In some further embodiments, the controller automatically activates the Peltier cooling module if it determines onset of the hot flash. In some further embodiments, the controller automatically modulates the cooling intensity of the Peltier cooling module. In some further embodiments, the controller automatically halts the operation of Peltier cooling module.

In some embodiments, the wearable device is configured to communicate with a user device using a communication module. In some further embodiments, the wearable device is configured to receive a control signal from the user device to activate the Peltier cooling module. In some further embodiments, the wearable device is configured to receive a control signal from the user device to modulate the cooling intensity of the Peltier cooling module. In some further embodiments, the wearable device is configured to receive a control signal from the user device to halt the operation of the Peltier cooling module. In some further embodiments, the wearable device is configured to receive a control signal from the user device to modulate the time period of activation of the Peltier cooling module. In some further embodiments, the wearable device is configured to receive a control signal from the user device to change the threshold temperature value of the measured temperature. In some further embodiments, the wearable device is configured to receive a control signal from the user device to change the specified time period of activation of the Peltier cooling module. In some further embodiments, the controller uses machine learning to control the time period of activation of the Peltier cooling module based on control signals received from the user device over a period of time. In some further embodiments, the controller uses machine learning to control the cooling intensity of the Peltier cooling module based on control signals received from the user device over a period of time.

In some embodiments, controller monitors the temperature measurement of the skin temperature sensor over the specified period of time to determine the activation state of the Peltier cooling module. In some further embodiments, the controller monitors the time duration of the activation state of the Peltier cooling module to determine the time period of delivery of treatment.

In some embodiments, the wearable device is configured in the shape of a neck band.

In some embodiments, the wearable device is configured in the shape of a wrist band.

In some embodiments, the wearable device is configured in the shape of a pendant.

In some embodiments, the wearable device is secured to a user’s body using an adhesive patch attached to the wearable device.

In some embodiments, the wearable device is a flexible wearable device. In some further embodiments, the wearable device comprises a flexible polymer body. In some further embodiments, the wearable device comprises a combination of flex electronics via a flex printed circuit board (PCB) or rigid-flex PCB. In some further embodiments, the wearable device comprises a flexible battery. In some further embodiments, the wearable device comprises a flexible heat sink.

In some embodiments, the wearable device comprises a charging module configured to charge a rechargeable battery for powering the wearable device.

In some embodiments, the wearable device comprises a button for turning the wearable device on or off. In some embodiments, the wearable device comprises an audio speaker configured to provide an auditory alert to the user.

In some embodiments, the wearable device comprises an LED light configured to provide a visible alert to the user.

In some embodiments, the cooling plate comprises a first metal plate, a second metal plate, and a metal oxide strip between the first metal plate and the second metal plate, where the metal oxide strip acts as a thermistor with known resistance values at various temperatures, and where the first metal plate and the second metal plate act as a pair of electrodes configured to provide microcurrent therapy to the user’s skin. In some further embodiments, a first lead connects the first metal plate to the internal circuit of the wearable device, and a second lead connects the second metal plate to the internal circuit of the wearable device.

In some embodiments, the cooling plate comprises a matrix comprising a first set of miniature metal plates connected to each other, and a second set of miniature metal plates connected to each other, where the first set of miniature metal plates are electrically isolated from the second set of miniature metal plates. In some further embodiments, a first lead connects the first set of miniature metal plates to the internal circuit of the wearable device, and a second lead connects the second set of miniature metal plates to the internal circuit of the wearable device.

Some other embodiments of the present invention disclose a wearable device to treat menopausal hot flashes configured to be placed in contact with a user’s skin. The wearable device comprises a cooling plate; a skin temperature sensor configured for measuring temperature of a user’s skin; a Peltier cooling module in contact with said cooling plate; a controller functionally connected to the skin temperature sensor and Peltier cooling module, where the controller is configured to measure a temperature of the user’s skin using the skin temperature sensor; determine if the measured temperature is beyond a threshold temperature value; activate the Peltier cooling module for a specified time period if the measured temperature is beyond said threshold temperature value, where the wearable device comprises a bioimpedance sensor, and where the electrodes of the bioimpedance sensor are configured to deliver microcurrent therapy to the user’s skin.

Some other embodiments of the present invention disclose a flexible wearable device to treat menopausal hot flashes configured to be placed in contact with a user’s skin, the wearable device comprising a cooling plate; a skin temperature sensor configured for measuring temperature of a user’s skin; a Peltier cooling module in contact with said cooling plate; a controller functionally connected to the skin temperature sensor and Peltier cooling module, where the controller is configured to: measure a temperature of the user’s skin using the skin temperature sensor; determine if the measured temperature is beyond a threshold temperature value; activate the Peltier cooling module for a specified time period if the measured temperature is beyond said threshold temperature value, where the wearable device comprises a flexible heat sink.

In some embodiments, the flexible heat sink is in the form of braided copper.

Description of Embodiments

FIGS. 1A-1H are schematic illustrations of an embodiment of the wearable device 100 to treat menopausal hot flashes configured to be adhered to a user’s skin 200 via an adhesive patch 103. In some embodiments, as shown in FIG. 1A, the wearable device 100 is adhered to the skin 200 of the back of the neck of the user.

As shown in the FIGS. 1A-1E, the wearable device 100 comprises a casing 101, cooling plate 102, the adhesive patch 103, a skin temperature sensor 104 configured for measuring temperature of a user’s skin 200, a Peltier cooling module 106 in contact with said cooling plate 102, and a controller 108 functionally connected to the skin temperature sensor 104 and the Peltier cooling module 106.

In some embodiments, the casing 101 is dimensioned to be worn comfortably by the user. In some embodiments, the casing 101 has a length ranging between 20-60 mm. In some embodiments, the casing 101 has a length of 40 ± 5 mm. In some embodiments, the casing 101 has a width ranging between 20 mm to 50 mm. In some embodiments, the casing 101 has a width of 35 ± 5 mm. In some embodiments, the casing 101 has a height ranging between 10 mm to 30 mm. In some embodiments, the casing 101 has a height of 14.5mm± 5 mm.

In some embodiments, the casing 101 is made of any suitable biocompatible material. For example, in some embodiments, the casing 101 or parts of the casing 101 can be made of polymers, such as Acrylonitrile Butadiene Styrene (ABS), Polypropylene, Polycarbonate, Polyethylene, Polyvinyl Chloride (PVC). In some embodiments, the casing 101 or parts of the casing 101 can be made of metals or metal alloys, such as stainless steel, cobalt-chromium alloy, titanium and its alloys, or nitinol.

In some embodiments, the casing 101 can be made using any commonly known manufacturing process, such as Injection Molding, Vacuum Casting, CNC Machining, or Fused Filament Fabrication.

In some embodiments, the adhesive patch 103 is a flexible piece of material that is configured to conform to the shape of the user’s skin 200 and the wearable device 100. In some embodiments, the adhesive patch 103 is made of a shape conforming film material and an adhesive backing. In some embodiments, the shape conforming film material can be any biocompatible material that can be adhered to the user’s skin. Some examples of such shape conforming film material include but are not limited to paper, cloth, polymers, such as Co-polyester, Polypropylene, Polyethylene, and Polyurethane. In some embodiments, the shape conforming film material may include a pouch or section shaped to conform to the shape of the device 100 to hold the device 100 in contact with the user’s skin 200. In some embodiments the adhesive backing may include any biocompatible adhesive to attach the adhesive patch 103 to the user’s skin 200. Some examples of such biocompatible adhesive materials include but are not limited to medical-grade Acrylic, Rubber, or Silicone Gel. In some embodiments, the skin temperature sensor 104 can be any commonly used skin temperature sensor such as a thermistor, thermocouple, or an infrared sensor. Some off-the shelf skin temperature sensors that can be used in the wearable device 100 include, but are not limited to: Texas Instruments® TIDA-99824, Melexis® MLX90632, Texas Instruments® TMP1075NDRLR, etc.

In some embodiments, the Peltier cooling module 106, also known as a thermoelectric cooler, is a semiconductor based electronic component that functions as a small heat-pump. Some commercially available Peltier cooling module 106 that can be used in the wearable device 100 includes, but are not limited to TEC1-12703 30 mm x 30 mm, TEC1 12706 30 mm x 30 mm, and TEC1-07107 30 mm x 30 mm.

In some embodiments, the controller 108 is a microcontroller or a microprocessor known in the art that is configured to control the operations of the wearable device 100. Some examples of off-the-shelf microcontrollers that can be used as the controller 108 include, but are not limited to NXP Semiconductors® MC9S08PT32AVLF, Texas Instruments® LM3S8962-EQC50-A2, and NXP Semiconductors® MCF51AG128VLH.

In some embodiments, the controller 108 keeps a track of the skin temperature of the user using the measurements of the skin temperature sensor 104. In some embodiments, the controller 108 is configured to measure a temperature of the user’s skin 200 using the skin temperature sensor 104, determine if the measured temperature is beyond a threshold temperature value, activate the Peltier cooling module 106 for a specified time period if the measured temperature is beyond said threshold temperature value.

In some embodiments, the threshold temperature value of the measured temperature is in the range of 30 °C and 40 °C. In some embodiments, the threshold temperature value of the measured temperature is in the range of 36.1 °C and 37.7 °C. In some embodiments, the Peltier cooling module 106 is activated for a specified time period ranging between 5-100 seconds. In some embodiments, the Peltier cooling module 106 is activated for a specified time period ranging between 10-60 seconds.

In some embodiments, the wearable device 100 comprises an ambient temperature sensor 110 configured for measuring an ambient temperature. In some embodiments, the ambient temperature sensor 110 can be selected from any one of the shelf available temperature sensors, including, but are not limited to Texas Instruments® TMP235A4DBZR, Microchip Technology Inc® AT30TS01-MAA5M-T, Texas Instruments® TMP236A4DCKR, and Microchip Technology Inc® MCP9701T- E/LT.

In some embodiments, the controller 108 measures the ambient temperature using the ambient temperature sensor, and determines said threshold temperature value using the ambient temperature sensor 110.

In some embodiments, the wearable device 100 comprises a bioimpedance sensor 112A, 112B in contact with said cooling plate 102, where the bioimpedance sensor 112A, 112B is configured to measure impedance of skin tissue that is in contact with the cooling plate 102. In some embodiments, the bioimpedance sensor 112A, 112B can include a pair of electrodes made of highly conductive metals or metal alloys including but not limited to gold, silver, platinum, copper, graphite, titanium, or brass.

In some embodiments, the controller 108 is configured to determine that the wearable device 100 is in contact with the user’s skin 200 by measuring the bioimpedance of the skin tissue. In some alternate embodiments, the bioimpedance sensor 112 comprises only one electrode and the cooling plate 102 acts as a second electrode.

In yet some other embodiments the cooling plate 102 is divided into two parts electrically isolated from one another acting as two electrodes similar to and functioning as the electrodes 112A and 112B. In some embodiments, the electrodes of the bioimpedance sensor 112A, 112B deliver microcurrent therapy to the user’s skin 200 that improves the user’s skins ’200 sensitivity to the cooling therapy. Improved skin sensitivity sensitizes the skin to temperature changes and lesser cooling can be used to provide a higher cooling sensation.

In some embodiments, the controller 108 measures the impedance of the cooling plate 102 to determine if the cooling plate 102 is in contact with the skin 200 of a user.

In some embodiments, the wearable device 100 comprises a heart rate sensor 114 configured to measure heart rate of the user. In some embodiments, the heart rate sensor 114 can be selected from any one of the shelf available heart rate sensors, including, but are not limited to Analog Devices® MAX30102EFD+T, and Maxim Integrated® MAX30100EFD+T.

In some embodiments, the controller 108 measures the heart rate of the user using the heart rate sensor 114 and is configured to determine the onset of a hot flash based on the measurement of the heart rate sensor 114.

In some embodiments, the controller 108 comprises a machine learning module 116. In some embodiments, the machine learning module 116 is implemented as a software component on the controller 108 using machine learning models optimized for micro-controllers, for example, but not limited to TensorFlow Lite ™, and Neuton TinyML®.

In some embodiments, the controller 108 uses the machine learning module 116 to determine onset of a hot flash using data measured from the skin temperature sensor 104, the ambient temperature sensor 110, the bioimpedance sensor 112A, 112B, and the heart rate sensor 114.

In some embodiments, the controller 108 automatically activates the Peltier cooling module 106 if it determines onset of the hot flash. In some embodiments, the controller 108 automatically modulate the cooling intensity of the Peltier cooling module 106. In some embodiments, the cooling intensity of the Peltier cooling module 106 is set proportional to the strength of the hot flash.

In some embodiments, the controller 108 automatically halts the operation of Peltier cooling module 106. In some embodiments, when the controller 108 determines that the hot flash has subsided, the controller 108 automatically halts the operation of the Peltier cooling module 106.

In some embodiments, referring to FIG. IE, the wearable device 100 is configured to communicate with a user device 300 using a communication module 118.

In some embodiments, the user device 300 can be any commonly used computing device that can be used by the user to communicate with the wearable device 100, for example, but not limited to a desktop computer, a laptop computer, a tablet, a mobile phone, or any specialized device configured with a user interface to allow the user to remotely instruct the wearable device 100 and receive information from the wearable device.

In some embodiments, the communication module 118 can use any of RF modulation, Bluetooth, Zigbee, Wi-Fi or other wireless communication protocols. In some embodiments, the communication module 118 can be selected from any one of the shelf available communication modules, including, but are not limited to Nordic Semiconductor® NRF52810-QFAA-R, Espressif Inc® ESP32-MINI-1-N4, Espressif Inc® ESP32-C3, etc.

In some embodiments, the communicating module 118 is enclosed in the casing 101. In some other embodiments, the communication module 118 is an accessory to the wearable device 100, attached to the casing 101 either internally or externally.

Another embodiment of the wearable device 100 can have some or all components of the wireless communication module 118 as an entire or partial portion of a retrieving component of the casing 101.

In some embodiments, the wireless communication module 118 is configured to receive control signals from the user device 300. In some embodiments, each control signal can be in the form of a binary code that the controller 108 can match with a prestored instructions table, comprising each instruction paired with a corresponding binary code, in its memory, to determine and execute the instructions provided by the user device 300.

In some embodiments, the wearable device 100 is configured to receive a control signal from the user device 300 to activate the Peltier cooling module 106.

In some embodiments, the wearable device 100 is configured to receive a control signal from the user device 300 to modulate the cooling intensity of the Peltier cooling module 106.

In some embodiments, the wearable device 100 is configured to receive a control signal from the user device 300 to halt the operation of the Peltier cooling module 106.

In some embodiments, the wearable device 100 is configured to receive a control signal from the user device 300 to modulate the time period of activation of the Peltier cooling module 106.

In some embodiments, the wearable device 100 is configured to receive a control signal from the user device 300 to change the threshold temperature value of the measured temperature.

In some embodiments, the wearable device 100 is configured to receive a control signal from the user device 300 to change the specified time period of activation of the Peltier cooling module 106.

In some embodiments, the controller 108 uses machine learning to control the time period of activation of the Peltier cooling module 106 based on control signals received from the user device 300 over a period of time.

In some embodiments, the controller 108 uses machine learning to control the cooling intensity of the Peltier cooling module 106 based on control signals received from the user device 300 over a period of time.

In some embodiments, the controller 108 monitors the temperature measurement of the skin temperature sensor 104 over the specified period of time to determine the activation state of the Peltier cooling module 106. In some embodiments, the controller 108 monitors the time duration of the activation state of the Peltier cooling module 106 to determine the time period of delivery of treatment.

In some embodiments, the wearable device 100 comprises a charging module 120 configured to charge a rechargeable battery for powering the wearable device 100.

In some embodiments, the rechargeable battery is comprised within the casing 101. In some embodiments, the rechargeable battery can be any commercially available lithium-polymer battery, that selected from any one of the shelf available batteries, including, but are not limited to Wiliyoung® WLY902025 400 mAh 3.7V single cell Rechargeable LiPo Battery, KP-501013 KP 3.7 V 40 mAh Lithium-ion, and KP 3.7 V DC 180 mAh Lithium Polymer Rechargeable Battery, KP-352224.

In some embodiments, the charging module 120 can be any known battery charger module, readily available off-the shelf, such as, but not limited to (MPS) Monolithic Power Systems® MP2667GG-0000-P, Texas Instruments® BQ24012DRCR, Texas Instruments® BQ24010DRCR.

In some embodiments, the charging module may include one pin connector, two pin connecter, USB Type A, Mini USB, Micro-USB, or metal contact pads to connect the charging module to the battery.

In embodiments with metal contact pads, the pads can be wiped clean and require minimal and easy maintenance. The ‘metal pads’ charging interface on the device can be placed in a docking station for charging. The docking station mentioned herein is defined as a structure that enables charging and may also act as a support to the device in a particular orientation for improved usability and/or aesthetic appeal. Alternatively, the metal contact pads can be connected to a magnetic pin charging cable for charging.

Another embodiment of the wearable device 100, comprising a rechargeable battery can be charged using a wireless method. One such approach is an inductively coupled charging method.

Another variation of the wearable device 100 may utilize an energy harvesting mechanism such as a solar or faraday charging to either recharge a battery or act as a direct battery module in itself. Another embodiment may utilize optical charging. Yet another embodiment contains power source that provides power to the embodiment for a fixed time, and cannot be recharged. In yet another embodiment, a passive power system in which an input created by mechanical, electrical, acoustic, or chemical action creates an electrical flow to thereby powering the system.

In some embodiments, the wearable device 100 comprises a button 122 for turning the wearable device 100 on or off. In some embodiments, the button 122 can be any one of but not limited to a toggle switch, a push button switch, a slide switch, a capacitive button, a DIP switch, a mini or micro pushbutton. Some examples, of commercially off-the-shelf available buttons 122 that can be used include, but not limited to C&K® PTS526 SKI 5 SMTR2 LFS, CUI Devices® TS02-66-43-BK-160- LCR-D, and CUI Devices® TS09-63-25-WT-260-SMT-TR.

In some embodiments, the user can manually trigger the cooling therapy by long pressing or double pressing the button 122.

In some embodiments, the wearable device 100 comprises an audio speaker 124 configured to provide an auditory alert to the user. In some embodiments, the audio speaker 124 can be any off-the-shelf commercially available speaker that is capable of producing an audible tone or notification, for example, but not limited to Soberton Inc® SP-1605-5, OLE WOLFF Elektronik® OWS-091630LA-8B, and OLE WOLFF Elektronik® OWS-131845TA-8D.

In some embodiments, the wearable device 100 comprises an LED light 126 configured to provide a visible alert to the user. In some embodiments, the LED light 126 can be a single color or RGB LED that may provide the visible alert to the user, for example, when the wearable device 100 is out of charge, or is charging, or is fully charged. Some examples of LED lights available off-the-shelf commercially that can be used with the wearable device 100 include, but are not limited to Worldsemi Co Limited® WS2812C-2020, Inolux® IN-PI22TAT5R5G5B, and Lucky Light Electronics Co Ltd® LL-FV4818RGBWX-IC. In some embodiments, the wearable device 100 comprises an accelerometer. In some embodiments, the accelerometer is used to determine the motion of the wearable device 100 when adhered to the user’s skin 200. The accelerometer can be selected from any commercially available off-the-shelf accelerometer, such as, but not limited to STMicroelectronics® LIS2DHTR, STMicroelectronics® AIS2DW12TR, and STMicroelectronics® LIS2DU12TR.

In some embodiments, the wearable device 100 comprises a gyroscope. In some embodiments, the gyroscope is used to determine the orientation of the wearable device 100 when adhered to the user’s skin 200. The gyroscope can be selected from any commercially available off-the-shelf accelerometer, such as, but not limited to STMicroelectronics® LSM6DSV16XTR, STMicroelectronics® ASM330LHBTR, and Bosch Sensortec® BMI088.

In some embodiments, the wearable device 100 can have memory for storage of sensed data from its various sensors. In some embodiments, the memory can be the internal memory of the controller 108. In some embodiments, the memory can be an external memory chip, commercially available off-the-shelf, such as, but not limited to Microchip Technology Inc® SST25VF010A-33-4C-SAE, Infineon Technologies AG® S25FL256SAGMFI000, and Micron Technology Inc® MT25QL01GBBB8ESF- 0AAT.

In some embodiments, the data can be ported wirelessly or by means of a wired connection. Embodiments with wired data transfer may include USB drives, memory cards, or data transfer cables connected to a computing device. Alternatively, data can be stored on the external device or in the cloud.

FIGS. 1F-1H illustrates various embodiments of the cooling plate 102 that can be incorporated in the embodiment of the wearable device 100.

Referring to FIG. IF, in some embodiments, the cooling plate 102 comprises two metal plates 102a and 102b separated by a vertical metal oxide strip 102c. Also, lead wires 102d and 102e connect the cooling plate 102 to the internal circuitry of the wearable device 100.

Similarly, an alternate embodiment shown in FIG. 1G, the cooling plate 102 comprises two metal plates 102a and 102b separated by a diagonal metal oxide strip 102c. Also, lead wires 102d and 102e connect the cooling plate 102 to the internal circuitry of the wearable device 100.

In the aforementioned embodiment of FIG. 1F-1G, the metal plates 102a and 102b act as lead wires and the metal oxide strip 102c behaves as a thermistor with known resistance values at various temperatures.

In some embodiments, the cooling plate 102a is made of highly conductive metals or metal alloys including but not limited to gold, silver, platinum, copper, graphite, titanium, or brass.

In some embodiments, the cooling plate 102b is made of highly conductive metals or metal alloys including but not limited to gold, silver, platinum, copper, graphite, titanium, or brass.

In some embodiments, the metal oxide strip 102c is made of metal oxides such as, but not limited to, Manganese Oxide (MnO), Nickel Oxide (NiO), Cobalt Oxide (CoO), Copper Oxide (CuO), and Iron Oxide (Fe2O3).

In some embodiments, the features can be used for feedback to maintain accurate temperature of the cold site of the Peltier cooling module 106.

Also, in some embodiments, the same construction can be used simultaneously for bio impedance measurement. For example, a typical Bioimpedance measurement is achieved by detecting the response to electric excitation (either current or potential) which is applied to a biological tissue using two metal leads 102a and 102b.

Also, in some embodiments, the bio impedance feature can be used to raise and alert in case the cooling plate 102 loses contact with the intended surface to be cooled. Further, in some embodiments, the same construction can be used simultaneously for micro-current therapy to enhance sensitivity of the skin.

Further, in yet another alternate embodiment shown in FIG. 1H, the cooling plate 102’ comprises a grid a multitude of such metal plates 102a’ and 102b’ can be incorporated in a miniature form to form a matrix structure similar to a touch screen design and can be used to provide localized micro current therapy at various locations across a cooling plate 102’, detect adherence at various locations across the cooling plate 102’ and measure temperature at various locations across the cooling plate 102’. For example, as shown in FIG. 1H, the cooling plate 102’ is formed a matrix of a first set of miniature metal plates 102a’ connected to each other, and a second set of miniature metal plates 102b’ connected to each other, where the first set of miniature metal plates 102a’ are electrically isolated from the second set of miniature metal plates 102b’. In some further embodiments, a first lead 102d’ connects the first set of miniature metal plates 102a’ to the internal circuit of the wearable device 100, and a second lead 102e’ connects the second set of miniature metal plates 102b’ to the internal circuit of the wearable device 100.

In some embodiments, the cooling plate 102a’ is made of highly conductive metals or metal alloys including but not limited to gold, silver, platinum, copper, graphite, titanium, or brass.

In some embodiments, the cooling plate 102b’ is made of highly conductive metals or metal alloys including but not limited to gold, silver, platinum, copper, graphite, titanium, or brass.

FIG. 2 is a flow chart illustrating an exemplary method 400 of operation of the embodiment of the wearable device of FIG. 1.

In some embodiments, the method 400 comprises a first initiation/start step 402 that represents turning on of the wearable device 100. This step can be performed using the on/off button 122 provided on the casing 101 of the wearable device 100. In the next step 404, the wearable device 100 (or the controller 108 of the wearable device 100) measures various parameters representative of the proper placement of the wearable device 100 on the user’s skin 200. In some embodiments, the parameters can be measurement values of various sensors on board the wearable device 100 such as the skin temperature sensor 104, bioimpedance sensor 112 A, 112B, and the heart rate sensor 114.

In the next step 406, the measured values of data captured by these sensors can be compared to pre-recorded data to determine proper placement of the wearable device 100 on the user’s skin 200.

In the next step 408, if it is determined that the device is not properly placed, the method moves on to step 410, else the method moves to step 412.

In the step 410, the wearable device 100 alerts the user of improper placement of the wearable device 100 so that the user can correct the placement of the wearable device 100.

In some embodiments, the user device 100 can alert the user using the audio speaker 124 or the LED light 126 or both. Other embodiments can generate alerts via visual, auditory, mechanical, or electrical means to inform the user or improve user compliance. Alerts may be transmitted via the wearable device 100 or may be transmitted to an external device such as the user device 300. Alerts can be used to indicate and promote frequency and correctness of use. The information of usage can be stored and referenced at later periods of time.

In step 412, the wearable device 100 measures the sensor data, i.e., data from the skin temperature sensor 104, bioimpedance sensor 112A, 112B, and the heart rate sensor 114.

In step 414, the wearable device 100 determines the onset of a hot flash by analyzing the sensor data. In some embodiments, machine learning module 116 is used to recognize patterns in the sensor data that are indicative of the onset of a hot flash. In step 416, if it is determined that the onset of a hot flash is detected, the method moves to step 418, else the method moves back to step 404.

In step 418, the wearable device 100 provides micro-current therapy locally to the skin underneath the wearable device 100 to improve skin sensitivity at the location of cooling plate 102. The improved skin sensitivity sensitizes the skin to temperature changes and lesser cooling can be used to provide a higher cooling sensation.

In step 420, the wearable device 100 provides cooling therapy to the user.

In step 422, the wearable device 100 monitors the cooling parameters to gauge the effectiveness of the cooling therapy. In some embodiments, the cooling parameters are monitored using the measurement data from the sensors, i.e., the skin temperature sensor 104, bioimpedance sensor 112A, 112B, and the heart rate sensor 114.

In step 424, if the wearable device 100 determines that the cooling is not effective, the method moves to step 426 and then returns back to step 424, else if the cooling is effective the method moves to step 428.

In step 426, the wearable device 100 modulates the cooling therapy to make it more effective. In some embodiments, the temperature of the cooling plate 102 is reduced further to increase the cooling effect on the user’s skin 200.

In step 428, the wearable device 100 halts the cooling therapy and returns to step 404.

The operation of the wearable device 100 may include other methods as well. Such as a method of promoting compliance is through incentives. One way is to track hot flashes via a scoring system. This scoring system can be a standalone system that takes in usage data and provides a performance review to the user. Another scoring system can be linked to a community where a user performance can be compared with other using the same device. Yet another system to incentivize compliance can be through marketplace discounts, promotions, or other financial/non-financial gains/rewards.

Alternate methods of incentivizing compliance are to connect the wearable device 100 usage to a user interface via an interactive platform in the wearable device 100 or externally via the user device 300. The wearable device 100 can be used as a control interface to a feedback representation on the user device 300. The wearable device 100 can be used as an input to an external feedback platform on the user device 300 or as response to an action given to the external feedback platform on the user device 300. This feedback representation can include but not limited to color variations, game control, graph outputs, or changes in user interface outputs. The external platform on the user device 300 can include but is not limited to computer programs and mobile applications.

In some embodiments, the external platform on the user device 300 can also be utilized to train the user on the correct usage of the embodiments. User input can help drive training regime. Additionally, performance history can help create user specific training regimes to improve output.

FIG. 3 is a schematic illustration of a second embodiment of the wearable device 100-2 of the present application. As shown, in some embodiments, where the wearable device 100-2 is configured in the shape of a wrist band. In said second embodiment, the internal components and functioning of the wearable device 100-2 will remain the same as disclosed with FIGS. IE and 2, and only the outer form/casing 101 of the wearable device 100-2 changes to adapt to a wrist band. For example, in said embodiments, the casing 101 of the wearable device 100-2 is dimensioned to be easily worn on the wrist of the user. Also, in said embodiment, instead of the adhesive patch 103, a wrist band may be used, where the wrist band includes a pouch for the wearable device 100-2 along with a Velcro strip or a latch mechanism for allowing the wrist band to be firmly strapped around the user’s wrist. FIG. 4 is a schematic illustration of a third embodiment of the wearable device 100-3 of the present application. As shown, in some embodiments, where the wearable device 100-3 is configured in the shape of a pendant. In said third embodiment, the internal components and functioning of the wearable device 100-3 will remain the same as disclosed with FIGS. IE and 2, and only the outer form/ shell of the wearable device 100 changes to adapt to a pendant. For example, in said embodiments, the casing 101 of the wearable device 100-3 may be dimensioned to be easily worn as a pendant. Also, in said embodiment, instead of the adhesive patch 103, a chain or a string may be used, where the chain or string is looped through a hole in the casing 101 of the wearable device 100-3 and a chain lock or hook system is present at the opposite end to lock the chain or string around the user’s neck.

FIG. 5 is a schematic illustration of a fourth embodiment of the wearable device 100-4 of the present application. As shown, in some embodiments, where the wearable device 100-4 is configured in the shape of a flexible wearable device, such as, a neck band, securable to the user’s skin using the adhesive patch 103.

In some embodiments, the flexible wearable device 100-4 comprises a flexible polymer body. In some embodiments, the casing 101 is made of a flexible polymer, such as, but not limited to Silicone, Polyvinyl chloride (PVC), Polyethylene Terephthalate Glycol (PETG), Polytetrafluoroethylene (PTFE), Polypropylene, and Thermoplastic elastomers (TPE).

In some embodiments, the wearable device 100-4 comprises a combination of flex electronics via a flex printed circuit board PCB or rigid-flex PCB. In some embodiments, the flexible PCB or rigid flexible PCB, is selected from one of, but not limited to, Single Layer Flex PCB, Dual-channel single-sided flexible PCB, Doublesided flexible PCB, and Multi-layer flexible PCB, commercially available off-the- shelf. In some embodiments, the wearable device 100-4 comprises a flexible battery. In some embodiments, the flexible battery, can be any commercially available flexible lithium-polymer flexible battery, that selected from any one of the shelf available batteries, such as, but not limited to: HHS® HHS- 18004, JX® JP403030, Youli 153030R.

In some embodiments, the wearable device 100-4 comprises a flexible heat sink. In some embodiments, the flexible heat sink is in the form of braided copper. In some other embodiments, the flexible heat sink is made of a Thin Graphite Film. In some other embodiments, the flexible heat sink is made of composite materials including a flexible polymer base, and layers of conductive metals placed thereon, such as, but not limited to copper, aluminum, silver, etc. Other known flexible heat sink materials may also be used.

Such an embodiment can conform very easily to the shape of the body where it is placed as well as provide a soft touch to the skin where it is placed.

The term “about” is intended to include the degree of error associated with measurement of the particular quantity and/or manufacturing tolerances based upon the equipment available at the time of filing the application.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the present disclosure. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, element components, and/or groups thereof.

Those of skill in the art will appreciate that various example embodiments are shown and described herein, each having certain features in the particular embodiments, but the present disclosure is not thus limited. Rather, the present disclosure can be modified to incorporate any number of variations, alterations, substitutions, combinations, sub-combinations, or equivalent arrangements not heretofore described, but which are commensurate with the scope of the present disclosure. Additionally, while various embodiments of the present disclosure have been described, it is to be understood that aspects of the present disclosure may include only some of the described embodiments. Accordingly, the present disclosure is not to be seen as limited by the foregoing description, but is only limited by the scope of the appended claims.

ADVANTAGES:

1. The present application provides a wearable device for treatment of menopausal hot flashes that automatically arrests the onset of a hot flash episode instead of waiting for a user to manually turn it on.

2. The present application provides a wearable device for treatment of menopausal hot flashes that automatically and accurately recognizes a hot flash using machine learning.

3. The present invention provides a flexible wearable device with flexible components including a flexible heat sink to add to the comfort of the wearer.

4. The present application provides a wearable device for treatment of menopausal hot flashes that, in some embodiments, uses a heart rate sensor to accurately identify a hot flash.

5. The present application provides a wearable device for treatment of menopausal hot flashes that, in some embodiments, uses the cold plate of the Peltier module as an impedance sensing element to identify if Peltier module is in contact with skin for detection and cooling. 6. The present application provides a wearable device for treatment of menopausal hot flashes that, in some embodiments, provides microcurrent therapy locally to the skin to improve skin sensitivity at the location of cooling .

Claims

We Claim:

1. A wearable device (100) to treat menopausal hot flashes configured to be placed in contact with a user’s skin (200), the wearable device comprising: a cooling plate (102); a skin temperature sensor (104) configured for measuring temperature of a user’s skin (200); a Peltier cooling module (106) in contact with said cooling plate (102); a controller (108) functionally connected to the skin temperature sensor (104) and Peltier cooling module (106), wherein the controller (108) configured to: measure a temperature of the user’s skin (200) using the skin temperature sensor (104); determine if the measured temperature is beyond a threshold temperature value; activate the Peltier cooling module (106) for a specified time period if the measured temperature is beyond said threshold temperature value.

2. The wearable device (100) as claimed in claim 1, wherein the threshold temperature value of the measured temperature is in the range of 36.1 °C and 37.7 °C

3. The wearable device (100) as claimed in claim 1 , wherein the Peltier cooling module (106) is activated for a specified time period ranging between 10-60 seconds.

4. The wearable device (100) as claimed in claim 1, wherein the wearable device (100) comprises an ambient temperature sensor (110) configured for measuring an ambient temperature, wherein the controller (108) measures the ambient temperature using the ambient temperature sensor, and determines said threshold temperature value using the ambient temperature sensor (110).

5. The wearable device (100) as claimed in claim 1, wherein the wearable device (100) comprises a bioimpedance sensor (112A, 112B) in contact with said cooling plate (102), wherein the bioimpedance sensor (112A, 112B) is configured to measure impedance of skin tissue that is in contact with the cooling plate (102), wherein the controller (108) is configured to determine that the wearable device is in contact with the user’s skin by measuring the bioimpedance of the skin tissue.

6. The wearable device (100) as claimed in claim 1, wherein the controller (108) measures the impedance of the cooling plate (102) to determine if the cooling plate (102) is in contact with the user’s skin (200).

7. The wearable device (100) as claimed in claim 1, wherein the wearable device (100) comprises a heart rate sensor (114) configured to measure heart rate of the user, and wherein the controller (108) measures the heart rate of the user using the heart rate sensor (114) and is configured to determine the onset of a hot flash based on the measurement of the heart rate sensor (114).

8. The wearable device (100) as claimed in claim 1, wherein the controller (108) comprises a machine learning module (116).

9. The wearable device (100) as claimed in claim 8, wherein the wearable device (100) comprises an ambient temperature sensor (110), a bioimpedance sensor (112A, 112B), and a heart rate sensor (114), wherein the controller (108) uses the machine learning module (116) to determine onset of a hot flash using data measured from the skin temperature sensor (104), the ambient temperature sensor (110), the bioimpedance sensor (112A, 112B), and the heart rate sensor (114).

10. The wearable device (100) as claimed in claim 9, wherein the controller (108) automatically activates the Peltier cooling module (106) if it determines onset of the hot flash.

11. The wearable device (100) as claimed in claim 10, wherein the controller (108) automatically modulates the cooling intensity of the Peltier cooling module (106).

12. The wearable device (100) as claimed in claim 11, wherein the controller (108) automatically halts the operation of Peltier cooling module (106).

13. The wearable device (100) as claimed in claim 1, wherein the wearable device (100) is configured to communicate with a user device (300) using a communication module (118).

14. The wearable device (100) as claimed in claim 13, wherein the wearable device (100) is configured to receive a control signal from the user device (300) to activate the Peltier cooling module (106).

15. The wearable device (100) as claimed in claim 13, wherein the wearable device (100) is configured to receive a control signal from the user device (300) to modulate the cooling intensity of the Peltier cooling module (106).

16. The wearable device (100) as claimed in claim 13, wherein the wearable device (100) is configured to receive a control signal from the user device (300) to halt the operation of the Peltier cooling module (106).

17. The wearable device (100) as claimed in claim 13, wherein the wearable device (100) is configured to receive a control signal from the user device (300) to modulate the time period of activation of the Peltier cooling module (106).

18. The wearable device (100) as claimed in claim 13, wherein the wearable device (100) is configured to receive a control signal from the user device (300) to change the threshold temperature value of the measured temperature.

19. The wearable device (100) as claimed in claim 13, wherein the wearable device (100) is configured to receive a control signal from the user device (300) to change the specified time period of activation of the Peltier cooling module.

20. The wearable device (100) as claimed in claims 13, wherein the controller (108) uses machine learning to control the time period of activation of the Peltier cooling module (106) based on control signals received from the user device over a period of time.

21. The wearable device (100) as claimed in claim 13, wherein the controller (108) uses machine learning to control the cooling intensity of the Peltier cooling module based on control signals received from the user device (300) over a period of time.

22. The wearable device (100) as claimed in claim 1, wherein the controller (108) monitors the temperature measurement of the skin temperature sensor (104) over the specified period of time to determine the activation state of the Peltier cooling module (106).

23. The wearable device (100) as claimed in claim 22, wherein the controller (108) monitors the time duration of the activation state of the Peltier cooling module (106) to determine the time period of delivery of treatment.

24. The wearable device (100) as claimed in claim 1, wherein the wearable device (100) is configured in the shape of a neck band.

25. The wearable device (100) as claimed in claim 1, wherein the wearable device (100) is configured in the shape of a wrist band.

26. The wearable device (100) as claimed in claim 1, wherein the wearable device (100) is configured in the shape i pendant.

27. The wearable device (100) as claimed in claim 1, wherein the wearable device (100) is secured to the user’s skin (200) using an adhesive patch (103) attached to the wearable device (100).

28 The wearable device (100) as claimed in claim 5, wherein the bioimpedance sensor (112A, 112B) comprises a pair of electrodes, and wherein the electrodes of the bioimpedance sensor (112A, 112B) are configured to deliver microcurrent therapy to the user’s skin (200).

29. The wearable device (100) as claimed in claim 1, wherein the wearable device is a flexible wearable device.

30. The wearable device (100) as claimed in claim 29, wherein the wearable device comprises a flexible polymer body.

31. The wearable device (100) as claimed in claim 29, wherein the wearable device comprises a combination of flex electronics via a flex printed circuit board (PCB) or rigid-flex PCB.

32. The wearable device (100) as claimed in claim 29, wherein the wearable device comprises a flexible battery.

33. The wearable device (100) as claimed in claim 29, wherein the wearable device comprises a flexible heat sink.

34. The wearable device (100) as claimed in claim 1, wherein the wearable device (100) comprises a charging module (120) configured to charge a rechargeable battery for powering the wearable device (100).

35. The wearable device (100) as claimed in claim 1, wherein the wearable device (100) comprises a button (122) for turning the wearable device (100) on or off.

36. The wearable device (100) as claimed in claim 1, wherein the wearable device (100) comprises an audio speaker (124) configured to provide an auditory alert to the user.

37. The wearable device (100) as claimed in claim 1, wherein the wearable device (100) comprises an LED light (126) configured to provide a visible alert to the user.

38. The wearable device (100) as claimed in claim 1, wherein the cooling plate (102) comprises a first metal plate (102a), a second metal plate (102b), and a metal oxide strip (102c) between the first metal plate (102a) and the second metal plate (102b), wherein the metal oxide strip (102c) acts as a thermistor with known resistance values at various temperatures, and wherein the first metal plate (102a) and the second metal plate (102b) act as a pair of electrodes configured to provide microcurrent therapy to the user’s skin (200).

39. The wearable device (100) as claimed in claim 38, wherein a first lead (102d) connects the first metal plate (102a) to the internal circuit of the wearable device (100), and a second lead (102e) connects the second metal plate (102b) to the internal circuit of the wearable device (100).

40. The wearable device (100) as claimed in claim 1, wherein the cooling plate (102) comprises a matrix comprising a first set of miniature metal plates (102a) connected to each other, and a second set of miniature metal plates (102b) connected to each other, where the first set of miniature metal plates (102a) are electrically isolated from the second set of miniature metal plates (102b).

41. The wearable device (100) as claimed in claim 40, wherein a first lead (102d) connects the first set of miniature metal plates (102a) to the internal circuit of the wearable device (100), and a second lead (102e) connects the second set of miniature metal plates (102b) to the internal circuit of the wearable device (100).

42. A wearable device (100) to treat menopausal hot flashes configured to be placed in contact with a user’s skin (200), the wearable device comprising: a cooling plate (102); a skin temperature sensor (104) configured for measuring temperature of a user’s skin (200); a Peltier cooling module (106) in contact with said cooling plate (102); a controller (108) functionally connected to the skin temperature sensor (104) and Peltier cooling module (106), wherein the controller (108) is configured to: measure a temperature of the user’s skin (200) using the skin temperature sensor (104); determine if the measured temperature is beyond a threshold temperature value; activate the Peltier cooling module (106) for a specified time period if the measured temperature is beyond said threshold temperature value, wherein the wearable device (100) comprises a bioimpedance sensor (112 A, 112B), wherein the bioimpedance sensor (112 A, 112B) comprises a pair of electrodes, and wherein the electrodes of the bioimpedance sensor (112A, 112B) are configured to deliver microcurrent therapy to the user’s skin (200).

43. A flexible wearable device (100) to treat menopausal hot flashes configured to be placed in contact with a user’s skin (200), the wearable device comprising: a cooling plate (102); a skin temperature sensor (104) configured for measuring temperature of a user’s skin (200); a Peltier cooling module (106) tact with said cooling plate (102); a controller (108) functionally connected to the skin temperature sensor (104) and Peltier cooling module (106), wherein the controller (108) is configured to: measure a temperature of the user’s skin (200) using the skin temperature sensor (104); determine if the measured temperature is beyond a threshold temperature value; activate the Peltier cooling module (106) for a specified time period if the measured temperature is beyond said threshold temperature value, wherein the wearable device comprises a flexible heat sink.

44. The flexible wearable device (100) as claimed in claim 43, wherein the flexible heat sink is in the form of braided copper.