Bathing device configured to measure capacitance changes in a body tissue due to pressure or density variations, associated system and method

Abstract

A bathing device (1) configured to measure the capacitance changes of the skin (1000,1001) due to alterations in the pressure or in the density of the skin caused by an anomaly (1002) includes a sponge layer (2) and a waterproof wrap (3), which encloses at least one flexible capacitive electrode (4). The flexible capacitive electrode (4) is configured to detect capacitance changes of the skin based on variations in the thickness of the sponge layer (d1,d2) based on the compression of the sponge by the user and by the anomalies (1002). The bathing device enables early detection of anomalies in a human body tissue, in particular in the human skin, and to monitor the evolution of the anomalies in the body tissue.

Description

A bathing device configured to measure changes in the capacity of body tissue due to changes in pressure or body tissue density, associated system and method.

[0001] The present invention relates to a bathing device configured to measure changes in the capacitance of a body tissue due to changes in the pressure or density of the body tissue, more particularly a bathing device including a sponge that is configured to measure changes in the capacitance of a body tissue, more particularly human skin.

[0002] The present invention falls within the field of medical devices, referring more specifically to a palpation sponge for detecting anomalies in biological tissues through palpation examination. State of the Art Problems

[0003] Early detection of abnormal changes in biological tissues is a fundamental step for the effective diagnosis and treatment of various pathologies, including oncological diseases.

[0004] Patent document US20100162832A1 describes a device including sensor arrangements integrated into wearable textiles for measuring both pressure and shear forces on the skin. The device is suitable for monitoring pressure and shear forces on the skin, primarily for individuals at risk of developing pressure ulcers (bedsores). The wearable textile can be in the form of clothing such as sweaters, socks, underwear, pajamas, bed sheets, or diapers, ensuring continuous skin contact for consistent monitoring.

[0005] The device described in US20100162832A1 has specific applications and is not suitable for detecting abnormal changes, such as skin tumors, which may manifest as nodules, localized hardening, or changes in tissue texture, often imperceptible to the naked eye but detectable by palpation.

[0006] Breast cancer is one of the most relevant examples in this context, representing the most common malignant neoplasm among women worldwide. The World Health Organization points out that early detection strategies, such as early clinical diagnosis and systematic screening, are crucial for improving prognosis and survival rates.

[0007] Palpation, as a physical examination technique, allows for the manual assessment of biomechanical tissue properties, such as stiffness, elasticity, and the presence of abnormal masses. The palpation examination should be repeated systematically and periodically, consisting of a series of assessments performed on the same anatomical region of the patient, consistently and according to a uniform method, with the aim of identifying changes in tissue texture.

[0008] However, its effectiveness is often limited by the examiner's subjectivity, inter-observer variability, and the lack of standardization of evaluation criteria.

[0009] In response to these limitations, technological solutions have been developed that aim to reduce the subjectivity of palpation examination through the systematic measurement of parameters such as applied force and tissue deformation.

[0010] These solutions allow for the identification of areas with greater relative stiffness, often associated with the presence of benign or malignant lesions, in a more precise and reproducible manner. Such devices can be applied to different anatomical zones, such as the breast, prostate, or other organs accessible externally or internally, expanding their potential use in the context of screening, early diagnosis, and monitoring of pathologies.

[0011] However, the state of the art has limitations regarding the availability of simple devices that can be used in routine daily activities to perform regular self-examinations in order to identify skin abnormalities. This practical gap is particularly relevant for breast self-examinations, since women do not have reliable and easy-to-use devices for the early detection and monitoring of the evolution of skin abnormalities.

[0012] Thus, there is not yet in the state of the art a device and corresponding method for examining the evolution of the texture of a biological tissue of a patient's organ, for example, the breast or the testicle, that allows for systematic and reliable monitoring of the texture of that organ over time, precisely identifying the position / size and other characteristics of any changes in that texture, should they occur, and allowing for their identification at an early stage. Solution to the Limitations of the State of the Art

[0013] In one aspect, the invention consists of a sponge, designed to aid in skin cleansing, which can be commonly used during the user's bath, being in contact with and / or immersed in water. In another aspect, the sponge integrates sensors that, through capacitive measurements, allow quantifying the pressure exerted by body tissue through the compression of the sponge itself. The measurements taken are based on the compression rate of the sponge, which, through a signal processing system, is able to extract characteristics of the body tissue.

[0014] Therefore, the present invention solves the problems of the prior art by incorporating a plurality of flexible capacitive electrodes along the bathing device, wherein the electrodes detect changes in skin capacitances caused by anomalies present, for example, in the dermis. The changes in skin capacitances are detected by considering variations in the thickness of the sponge that is part of the bathing device during the user's bath. Advantageous Effects of the Invention

[0015] The bathing device of the present invention allows for the early detection of anomalies in human body tissue, particularly in human skin, and the monitoring of the evolution of anomalies in body tissue.

[0016] The bathing device according to the invention increases the likelihood of regular checkups, since the process integrates seamlessly into the user's daily routine without requiring additional effort or significant changes in habits.

[0017] For the purpose of promoting an understanding of the principles in accordance with the embodiments of the present invention, reference will be made to the embodiments illustrated in the figures and to the language used to describe them. In any case, it should be understood that there is no intention to limit the scope of the present invention to the content of the figures. Any subsequent alterations or modifications of the inventive features illustrated herein, as well as any additional applications of the principles and embodiments of the invention illustrated, which would normally occur to a person skilled in the art possessing this description, are considered within the scope of the claimed invention. Fig. 1

[0018] [Fig. 1] illustrates a first embodiment of a bathing device according to the invention to be compressed onto the skin surface; Fig. 2

[0019] [Fig. 2] illustrates a second embodiment of a bathing device according to the invention to be compressed onto the skin surface; Fig. 3

[0020] [Fig. 3] illustrates a cross-sectional view of a third embodiment of a bathing device according to the invention; Fig. 4

[0021] [Fig. 4] illustrates a cross-sectional view of a fourth embodiment of a bathing device according to the invention; Fig. 5

[0022] [Fig. 5] illustrates a cross-sectional view of a fifth embodiment of a bathing device according to the invention; Fig. 6

[0023] [Fig. 6] illustrates a longitudinal cross-sectional view of the contact interface between the sponge layer and a printed circuit board including a plurality of flexible capacitive electrodes; Fig. 7

[0024] [Fig. 7] illustrates a system configured for measuring changes in the capacitance of a body tissue according to the invention; Fig. 8

[0025] [Fig. 8] illustrates the integration between flexible capacitive electrodes and a processing unit incorporated inside the waterproof housing.

[0026] The present invention, in a first aspect and as illustrated in Figure 1, relates to a bathing device (1) configured to measure changes in the capacitance of a body tissue due to changes in the pressure or density of the body tissue comprising:

[0027] a layer of sponge (2); and

[0028] a waterproof covering (3); and

[0029] a flexible capacitive electrode (4); and

[0030] an electrical power supply unit (6); and

[0031] a first data communication unit (7); and in which

[0032] the waterproof wrapper (3) is placed over the sponge layer (2); and in which

[0033] the waterproof enclosure (3) encloses at least one flexible capacitive electrode (4), the electrical power supply unit (6) and the first data communication unit (7); and wherein

[0034] the flexible capacitive electrode (4) is electrically powered by the electrical power supply unit (6) and is configured to transmit the measured data of changes in body tissue capacitance to the first data communication unit (7); and wherein

[0035] the flexible capacitive electrode (4) is disposed on an inner lower surface of the waterproof enclosure (3) and wherein the inner lower surface of the waterproof enclosure (3) is disposed in a position adjacent to the upper surface of the sponge layer (2).

[0036]

[0037] In another embodiment, as illustrated in Figure 2, a second sponge layer (8) is placed over the waterproof wrapper (3). Even more preferably, the waterproof wrapper (3) is enclosed by a foam wrapper, which comprises the sponge layer (2), the second sponge layer (8) and at least one lateral sponge layer (9).

[0038] Preferably, as illustrated in Figure 2, the bathing device (1) comprises at least one second flexible capacitive electrode (5); wherein

[0039] the waterproof casing (3) encloses the second flexible capacitive electrode (5); and wherein

[0040] the second flexible capacitive electrode (5) is electrically powered by the electrical power supply unit (6) and is configured to transmit the measured data of changes in body tissue capacitance to the first data communication unit (7); and wherein

[0041] the second flexible capacitive electrode (5) is disposed on an inner upper surface of the waterproof enclosure (3) and wherein the inner upper surface of the waterproof enclosure (3) is disposed in a position adjacent to the lower surface of the second sponge layer (8).

[0042]

[0043] Preferably, the flexible capacitive electrodes (4) are arranged in a support layer, wherein the support layer is arranged on an inner lower surface of the waterproof enclosure (3). Similarly and preferably, the second flexible capacitive electrodes (5) are arranged in a second support layer, wherein the second support layer is arranged on an inner upper surface of the waterproof enclosure (3). Preferably, the support layer and the second support layer are selected from the group consisting of a flexible plastic film, a flexible printed circuit board, a film of an elastomer, a silicone film, a fabric, a non-woven fabric, a conductive foam film, a sheet of impregnated technical paper, a film impregnated with at least one hydrogel, an adhesive tape, their laminates, combinations and composites.The support layer and the second support layer provide electrical insulation, thermal resistance, and mechanical flexibility, and are dimensioned to meet requirements for anatomical conformity and resistance to bending fatigue.

[0044] Flexible capacitive electrodes (4) and second flexible capacitive electrodes (5) can be incorporated respectively into the support layer and the second support layer by means of various deposition methods, such as screen printing, vacuum deposition, multilayer lamination, chemical etching, laser cutting, extrusion or hydrogel spray application or dry transfer.

[0045] Screen printing or inkjet printing involves the deposition of a conductive ink based on metals, conductive polymers, or carbonaceous materials onto the support layer, followed by thermal curing in the range of 80 to 150 °C or exposure to ultraviolet light to consolidate the substrate film.

[0046] Vacuum deposition refers to the evaporation or sputtering of noble metals or oxides in a vacuum chamber, employing masking or photolithography processes for pattern definition, with a subsequent annealing step in the range of 200 to 300 °C.

[0047] Multilayer lamination refers to the sequential stacking of dielectric and conductive films, bonded together by controlled heat and pressure, forming a self-supporting structural assembly.

[0048] Chemical etching or laser cutting involves the selective removal of a conductive film on a support film to form high-resolution tracks.

[0049] Extrusion or spray application of hydrogels / foams refers to the direct application of conductive hydrogels or foams onto the substrate to obtain conformable electrodes.

[0050] Dry transfer refers to the transfer of prefabricated layers of graphene or conductive polymers to the final substrate, minimizing mechanical stress and preserving the integrity of the film.

[0051] Preferably, at least one of the group consisting of the sponge layer (2), the second sponge layer (8) and the foam wrap is impregnated with water or as an aqueous solution, the aqueous solution being a solution including at least one skin cleansing agent, such as a detergent, a soap.

[0052] In certain particularly preferred embodiments, at least one of the group consisting of the sponge layer (2), the second sponge layer (8) and the foam wrap is impregnated with silver nanoparticles, which have antibacterial action.

[0053] As illustrated in Figures 1 or 2, when the sponge layer (2) is compressed by the user against their skin during bathing, the flexible capacitive electrode (4) and, optionally, the second flexible capacitive electrode (5) detect changes in skin capacitances caused by anomalies (1002), present for example in the dermis (1001). Changes in skin capacitances are detected by considering variations in the thickness of the sponge, for example the different thicknesses d1 and d2 of the sponge layer (2). In particularly advantageous terms, considering the intrinsic properties of a sponge to absorb water or aqueous solutions, there is a particularly advantageous amplification of the capacitive sensory capacity of the flexible capacitive electrodes (4,5).

[0054] Human skin is an example of body tissue and includes the epidermis, dermis, and hypodermis. The invention is applicable in clinical and screening contexts, aiming at the early identification of structural changes associated with various pathologies, including, but not limited to, neoplasms such as breast or prostate cancer.

[0055] Capacitive sensors measure changes in capacitance between two conductive plates, which can be influenced by the distance between them and the dielectric material between the plates. Capacitance C is given by the formula:

[0056]

[0057]

[0058] Where εr is the relative permittivity (dielectric constant) of the material between the conducting plates; ε0 is the permittivity of free space; A is the area of ​​the conducting plates; ed is the distance between the conducting plates.

[0059] Capacitive sensing sensors measure changes in capacitance between capacitive electrodes. When the distance between the capacitive electrodes changes, or the dielectric properties of the material between them change, the capacitance also changes. This principle can be used to detect various forms of touch, pressure, or proximity between the capacitive electrodes.

[0060] The use of the human body as an electrode that is referenced by the flexible capacitive electrodes incorporated in the bathing device (1) introduces an interesting dynamic in the capacitive measurement setup for evaluating the compression of the bathing device (1). This setup is based on the principle that the human body can also act as a capacitor, and changes in capacitance can be detected when the human body interacts with another capacitive element, such as its detection circuit including the flexible capacitive electrodes. In this setup, the human body itself becomes part of the capacitive detection system. Contact or proximity of the skin to the bathing device (1) alters the overall capacitance measured by the flexible capacitive electrodes. The flexible capacitive electrodes incorporated in the bathing device (1) act as reference electrodes for the circuit.When pressure is applied to the sponge, for example by pressing it against the waterproof casing (3), the change in capacitance due to the altered physical and dielectric properties of the sponge layer is detected. When pressure is applied, for example when the user presses the sponge layer against the waterproof casing (3), the physical deformation of the sponge layer alters the distance and dielectric properties between the human body, which acts as an electrode, and flexible capacitive electrodes, which act as reference electrodes of the circuit.

[0061] A sponge can absorb liquids, which generally have a higher dielectric constant than air or even a dry sponge. When a sponge is wet, its effective dielectric constant increases, which increases the capacitance measured by the sensor. This absorption capacity can even be used to detect the amount of liquid inside the sponge.

[0062] When the sponge is compressed, specifically the sponge layer (2), by changing for example d1 and d2 depending on skin anomalies, the thickness d of the sponge layer (2) between the sensor plates changes, further altering the capacitance. This double modulation, i.e., compression of the sponge and its saturation with a liquid, can effectively provide a more dynamic and sensitive measurement range.

[0063] By combining the effects of liquid absorption by the sponge, which results in an increase in its dielectric constant, and the mechanical compression of the sponge, which leads to a decrease in the distance d, the range and sensitivity of the sensor can be significantly improved. This can be particularly useful in applications where it is necessary to detect fine gradations of pressure or moisture content in the sponge.

[0064] Thus, within the scope of the present invention, the flexible capacitive electrodes (4,5) detect changes in the dielectric constant of the sponge layer (2) and the second sponge layer (8) when the latter is compressed against the waterproof enclosure (3) that houses the flexible capacitive electrodes (4,5). Therefore, changes in the dielectric constant result from variations in the distance between the flexible capacitive electrodes (4,5) and the thickness of the sponge layer (2,8). Changes in the dielectric constant can also be caused by the amount of water, which has a high dielectric constant, near the flexible capacitive electrodes (4,5). These changes in physical and dielectric properties affect the capacitance between the human body and the circuit reference. As the sponge compresses, it can expel water, reducing its dielectric constant and consequently the capacitance.

[0065] Without being bound by any theory, the changes in the dielectric constant detected as the sponge layer (2,8) is compressed are influenced by the change in the sponge's structure, the reduction in its volume, and the consequent greater exposure of the flexible capacitive electrodes (4,5) to any water present in the sponge layer (2,8). This set of factors influences the dielectric properties in the vicinity of the capacitive mesh, thus altering the capacitance measured by the flexible capacitive electrodes (4,5).

[0066] The bath device (1) is pre-calibrated by establishing baseline capacitance readings without pressure and readings measured with various predefined compression levels, in order to properly interpret changes in capacitance as pressure or compression measurements.

[0067] Preferably, the bathing device (1) includes a plurality of flexible capacitive electrodes (4) arranged longitudinally on the inner lower surface of the waterproof casing (3) and parallel to the upper surface of the sponge layer (2) and / or a plurality of second flexible capacitive electrodes (5) arranged longitudinally on the inner upper surface of the waterproof casing (3) and parallel to the lower surface of the second sponge layer (8). The technical advantage of this configuration is related to the increased density of the electrode grid, thus reducing the distance between the measurement points, improving spatial resolution and sensitivity to localized changes along the contact surface between the device (1) and human skin.In this way, overall sensitivity can be increased by about 10-15%, allowing for more precise mapping of changes in body tissue density, particularly human skin.

[0068] Even more preferably, the flexible capacitive electrodes (4) and / or the second flexible capacitive electrodes (5) are arranged in an interdigitated configuration. Changing to an interdigitated electrode configuration from a simpler grid can increase sensitivity by improving the electric field interaction between the electrodes. This configuration improves sensitivity by about 20-30%, depending on the previous arrangement and spacing of the flexible capacitive electrodes (4) and / or the second flexible capacitive electrodes (5).

[0069] Even more preferably, the flexible capacitive electrodes (4) and / or the second flexible capacitive electrodes (5) have a planar shape and can be incorporated along a longitudinal surface of the bathing device (1) in order to create a mesh covering a significant area of ​​said longitudinal surface, which is parallel to the longitudinal surface of the sponge layer (2) and / or the second sponge layer (8). This arrangement allows localized capacitance measurements across the entire surface of the bathing device (1).

[0070] Preferably, the flexible capacitive electrodes (4) and / or the second flexible capacitive electrodes (5) are coated with a conductive film in order to increase the conductivity and responsiveness of the electrodes, which potentially increases the signal strength and responsiveness of the capacitive sensors by about 5-10%. Conductive films include metallic films, metallic alloy films and polymeric films. Examples of conductive metals include gold, silver and copper. Examples of conductive polymers include polyaniline, polypyrrole, polyethylene dioxythiophene, polyethylene dioxythiophene-polyestersulfonate complex, polythiopene and polyfluorene.

[0071] Even more preferably, the flexible capacitive electrodes (4) and / or the second flexible capacitive electrodes (5) can be coated with a uniform dielectric layer, which stabilizes the readings and reduces ambient noise, potentially improving the accuracy and reliability of the measurement by about 10-20%, wherein this coating can be incorporated alone or in conjunction with the coating with the conductive film.

[0072] In preferred embodiments, each flexible capacitive electrode (4,5) is formed from conductive material selected from the group consisting of graphene, carbon nanotubes, conductive polymers, metals, conductive hydrogels, conductive textiles, metallic nanowires and their composites. The conductive polymers include, without limitation, polyaniline, polypyrrole, polyethylene dioxythiophene (PEDOT), PEDOT complex with polyestersulfonate (PEDOT:PSS), polythiophene and polyfluorene. The metals comprise gold, silver, copper, platinum, aluminum foil and their alloys, coatings or nanoparticles of gold, silver, copper and aluminum.

[0073] The selection of the interface material between the waterproof housing (3) and the flexible capacitive electrodes (4,5) must balance dielectric permittivity, mechanical conformability, and long-term stability. For high resolution on regular surfaces, films such as dimethyl polysiloxane, PDMS, conformal Parylene C, or double-sided polyethylene terephthalate, PET, tapes with acrylic adhesive are preferred, as they fill microgaps without compromising sensitivity. On irregular surfaces or for noise reduction, silicone gels, hydrogels, or acrylic foam tapes are applicable, for example, which guarantee excellent conformability and damping. BaTiO₃–PDMS nanocomposites and polyurethane gel, PU, ​​combine flexibility and high permittivity, while epoxy resins with high relative permittivity provide superior rigidity and insulation at the cost of less conformability.The application can be done by spin-coating, molding, injection, or simply by positioning the tape under uniform pressure.

[0074] In an alternative embodiment, flexible capacitive electrodes (4,5) can be integrated into contact interfaces that include a protective layer of biocompatible polymer or elastomer, ensuring skin adhesion and moisture protection. In another alternative, it is understood that composites of metallic nanowires dispersed in a flexible polymer matrix are formed, or carbon nanotube networks are incorporated into polymer links, obtaining electrodes with high ductility, low surface resistivity and excellent resistance to bending fatigue. The geometric configuration of the electrodes can be defined by high-resolution printing or engraving techniques, in order to meet requirements of sensitivity, spatial resolution and uniformity of capacitive response.

[0075] In preferred embodiments of the present invention, analog-to-digital converters (22) are implemented, improving the ability to detect small changes in capacitance, contributing to an improvement in sensitivity of about 5-10%.

[0076] Preferably, the flexible capacitive electrodes (4) and / or the second flexible capacitive electrodes (5) are made from a material selected from the group including graphene, carbon nanotubes, conductive polymers, metals, conductive hydrogels, conductive textiles, metallic nanowires, and their composites. Examples of conductive polymers include polyaniline, polypyrrole, polyethylene dioxythiophene, polyethylene dioxythiophene complex with polyestersulfonate, polythiopene, and polyfluorene. Examples of metals include thin sheets or coatings of metals such as gold, silver, copper, and aluminum, or coatings including their nanoparticles.

[0077] Preferably, the sponges that can be used in sponge layers (2,8,9) are made from a material selected from the group including natural sea sponges, vegetable fiber sponges, synthetic sponges, cellulose sponges and their composites. Examples of vegetable fiber sponges include luffa and konjac. Examples of synthetic sponges include polyurethane, silicone, polyether, nylon and vinyl sponges.

[0078] Preferably, the waterproof envelope (3) is made from a material selected from the group consisting of polyethylene, polypropylene, polyvinyl chloride, ethylene-vinyl acetate, polyvinylidene fluoride, silicones, polycarbonate, acrylonitrile butadiene styrene – ABS, polyether ether ketone – PEEK, nylon, epoxy resins, glass or carbon fiber reinforced polyester, alumina or zirconia-based ceramics, acrylonitrile styrene – SAN, their composites and copolymers, such as polyphenylene-polystyrene – PPO-PS and ABS-polycarbonate.

[0079] In a preferred embodiment, the waterproof envelope (3) has a rigid configuration, being made from thermoplastics such as polycarbonate, ABS, PEEK or nylon, as well as composites of epoxy or polyester resins reinforced with glass or carbon fibers, technical ceramics based on alumina or zirconia with low dielectric loss and their mixtures or copolymers such as SAN, PPO-PS or ABS-PC, all chosen for their structural rigidity, impermeability and controlled dielectric permittivity that allows the transmission of electric fields without distortion.

[0080] Alternatively, the waterproof housing (3) may be flexible, being made of selected materials from the group consisting of polyethylene, polypropylene, polyvinyl chloride, ethylene-vinyl acetate, polyvinylidene fluoride, silicones, as well as their composites and copolymers, whose mechanical conformability and adequate dielectric constant ensure adherence to the device contour and effective transmission of the electric fields required for the operation of capacitive sensors, maintaining impermeability and environmental stability throughout the product's service life.

[0081] In particularly preferred embodiments, the flexible capacitive electrodes (4) are incorporated into a first printed circuit board (11) and / or the second flexible capacitive electrodes (5) are incorporated into a second printed circuit board (12). The first printed circuit board (11) and the second printed circuit board (12) may be rigid or flexible.

[0082] Preferably, the bathing device (1) comprises at least one supplementary sensory unit (10); wherein the supplementary sensory unit (10) is incorporated within the waterproof enclosure (3); wherein the supplementary sensory unit (10) is configured to transmit the measured data to the first data communication unit (7); and wherein the supplementary sensory unit (10) includes at least one sensor selected from the group consisting of an inertial measurement sensor, a temperature sensor, a humidity sensor, a pressure sensor, a force sensor, an optical sensor, a pH sensor, a conductivity sensor, a touch sensor and a biometric sensor to record bath water conditions, other environmental factors, as well as user-related factors.Inertial measurement sensors, such as accelerometers, gyroscopes and magnetometers, also contribute to calibrating or validating the measurements of flexible capacitive electrodes (4,5), which helps to reduce noise in the readings.

[0083] In a particularly preferred embodiment, the bathing device (1) comprises a first computational processing unit (13); wherein the first computational processing unit (13) is incorporated within the waterproof enclosure (3); wherein the first computational processing unit (13) is configured to receive capacitance data from a body tissue transmitted by the first data communication unit (7), process said data and calculate the pressure or density of the body tissue. Even more preferably, the first computational processing unit (13) is incorporated in a second printed circuit board (12) or in a third printed circuit board (14). The third printed circuit board (14) may be rigid or flexible.

[0084] In particularly preferred embodiments, the bathing device (1) may include a screen (17), which may additionally display a graphical user interface in addition to the measured data and results calculated by the first computational processing unit (13). Alternatively, the bathing device (1) may include a light indicator (16), for example an LED, or a local signal (25), such as an audible indicator, which may be configured to emit an alert when a certain result is calculated by the first computational processing unit (13). For example, visible changes in the measured density or patterns that deviate from typical basic measurements trigger alerts advising the user to seek professional advice.

[0085] The electrical power supply unit (6) may be a rechargeable, waterproof battery integrated into the bathing device (1) and enclosed by the waterproof casing (3). The flexible capacitive electrode (4) and the second flexible capacitive electrode (5) are electrically powered by the electrical power supply unit (6). Wireless charging capabilities may be added to facilitate charging of the electrical power supply unit (6), for example magnetic induction charging bases.

[0086] As illustrated in Figure 6, in the bathing device (1), the flexible capacitive electrodes (4) are electrically powered by the power supply unit (6) and are configured to transmit the measured data of changes in body tissue capacitance to the first data communication unit (7), where optionally the data may be pre-processed by a first computational processing unit (13), which is also powered by the power supply unit (6). The bathing device (1) may also include complementary sensory units (10), configured for example to measure the temperature and humidity of the device.

[0087] Figure 8 illustrates one embodiment of the integration between flexible capacitive electrodes (4,5) and a processing unit incorporated inside the waterproof enclosure (3). The flexible capacitive electrodes (4,5) connect to a first printed circuit board (11), which in turn integrates with a first integrated circuit (23), which includes a signal conditioning circuit (24) and an analog-to-digital converter (22). The digital signals obtained via flexible capacitive electrodes (4,5) and the signals obtained via an independent set of sensors, for example an inertial measurement sensor (19), a temperature sensor (20) and a humidity sensor (21) are sent to a microcontroller (15) which processes them and sends them to an I / O input / output module (18). The signals can be perceived by a user on a screen (17), on a light indicator (16), on a local indicator (25) or on a feedback module (26).The device (1) also communicates wirelessly with a computational device (101), wherein the computational device (101) performs processing of the signals collected by the sensors to identify deviations from reference parameters for body tissue pressure or density and to assign said deviations to a clinical condition. The integrated circuits (23,27) may be ASIC and SoC circuits.

[0088] Figure 6 illustrates one embodiment of the integration between the flexible capacitive electrodes (4) with an electrical power supply unit (6), a first data communication unit (7) and a complementary sensory unit (10) inside the waterproof enclosure (3). The signals detected by the flexible capacitive electrodes (4) are perceived by a user on a screen (17) and on a light indicator (16).

[0089] Figure 3 illustrates one embodiment of a bathing device (1) including a first printed circuit board (11) and a second printed circuit board (12), both boards incorporated within the waterproof enclosure (3). Flexible capacitive electrodes (4) and / or second flexible capacitive electrodes (5) are incorporated into at least one of the first printed circuit board (11) and the second printed circuit board (12). The first computational processing unit (13) is incorporated into the second printed circuit board (12).

[0090] Figure 4 illustrates another embodiment of a bathing device (1) including a first printed circuit board (11) and a second printed circuit board (12), both boards incorporated inside the waterproof enclosure (3). The flexible capacitive electrodes (4) are incorporated into the first printed circuit board (11) and the first computational processing unit (13) is incorporated into the second printed circuit board (12).

[0091] Figure 5 illustrates one embodiment of a bathing device (1) including a first printed circuit board (11), a second printed circuit board (12) and a third printed circuit board (14), wherein said boards are incorporated within the waterproof enclosure (3). Flexible capacitive electrodes (4) are incorporated into the first printed circuit board (11) and the second flexible capacitive electrodes (5) are incorporated into the third printed circuit board (14). The first computational processing unit (13) is incorporated into the second printed circuit board (12).

[0092] The present invention, in a second aspect illustrated in Figure 7, relates to a system (100) configured for measuring changes in the capacitance of a body tissue comprising the bathing device (1), as defined in the first aspect of the invention, and further comprising:

[0093] a computing device (101), which includes a second computing processing unit (102) and a second wireless data communication unit (103); and wherein

[0094] the first data communication unit (7) of the device (1) is configured to transmit the data obtained by the flexible capacitive electrode (4) and / or by the second flexible capacitive electrode (5) to the second wireless data communication unit (103); and wherein

[0095] The second computational processing unit (102) is configured to process the capacitance data of a body tissue received by the second wireless data communication unit (103) and calculate the pressure or density of the body tissue.

[0096]

[0097] In particularly preferred embodiments, the computing device (101) may be a smartphone or a tablet, which may additionally display a graphical user interface showing the measured data and the results calculated by the second computing processing unit (102). The second computing processing unit (102) may be configured to run an alerting module in the graphical interface, for example, alerts relating to visible changes in measured density or patterns that deviate from typical baseline measurements trigger alerts advising the user to seek professional advice. The graphical user interface may also display information on the proper way to use the bathing device (1).

[0098] The first data communication unit (7) preferably uses a wireless technology, for example, Bluetooth Low Energy or low-power radio frequency. In the system (100) configured for measuring changes in human skin capacitance, the first data communication unit (7) is preferably used to transmit data to a computing device (101), for example, a smartphone. The computing device (101) includes a second wireless data communication unit (103), configured to receive the data transmitted by the first data communication unit (7), and a second computing processing unit (102), which is configured to process and securely store the calculated data and results.

[0099] Preferably, the first computational processing unit (13) incorporated in the bathing device (1) and / or the second computational processing unit (102) incorporated in the system (100) incorporate a filtering module configured to improve signal quality by removing irrelevant noise and focusing on significant changes in body tissue capacitance, resulting in improved data quality and sensor accuracy of approximately 10-15%. The filtering modules may include high-pass filters and / or low-pass filters.

[0100] The properties of human skin can vary greatly due to factors such as humidity, applied pressure, and contact surface area. These variations can introduce noise or inconsistency in capacitance readings, and this undesirable effect can be avoided or mitigated by the filtering module.

[0101] Preferably, the first computational processing unit (13) incorporated in the bathing device (1) and / or the second computational processing unit (102) incorporated in the system (100) incorporate a dynamic calibration module that is configured to adjust to the individual user conditions and compensate for sensor aging, the overall reliability and accuracy of the sensor readings, which can be improved by about 10-20%.

[0102] The combined action of the filtering and dynamic calibration modules potentially improves the sensitivity and range of the capacitive electrodes of the bathing device (1) by at least 30 to 50%, depending on the initial baseline performance. These improvements not only make the bathing device (1) more effective in detecting changes in skin density, for example in the breast region, but also make the bathing device (1) easier to use and adapt to varying conditions.

[0103] Therefore, the bath device (1) is particularly suitable for measuring the difference in breast density, and can facilitate and encourage regular self-examinations. The integration of flexible capacitive electrodes into a bath sponge allows the bath device (1) to measure changes in capacitance caused by compression and density of breast tissue during normal bathing routines, detecting variations in breast density. Thus, using a bath device (1), such as a bath sponge, increases the likelihood of performing regular examinations, as the process integrates seamlessly into the user's daily routine without requiring additional effort or significant changes to habits. This practical advantage is particularly important for many women who end up not performing regular self-examinations due to forgetfulness, lack of time, or uncertainty about the correct way to perform them.A bath sponge equipped with a sensor makes this routine process simple and effortless, ensuring more consistent monitoring of a person's health. By regularly collecting data on breast density, the bath device (1) can detect subtle changes earlier than occasional self-exams, which can lead to earlier intervention and treatment. Over time, the accumulated data provides information on the normal variability of breast tissue density and helps distinguish between normal changes and those that may require further investigation. Therefore, the use of non-invasive capacitive detection technology incorporated into a daily-use device provides a safe and easy-to-use method for monitoring breast health, without exposure to radiation or other risks associated with more invasive techniques.

[0104] In particularly preferred embodiments, the thickness of the sponge layer (2) and the thickness of the second sponge layer (8) are in the range of 0.5 to 5 cm, more preferably in the range of 1 to 3 cm.

[0105] Preferably, the bathing device (1) is ergonomically sized to fit comfortably in the hand, similar to normal bath sponges, with a diameter or longitudinal length of about 12 to 15 cm.

[0106] The present invention, in a third aspect, relates to a computer-implemented method for calculating parameters related to the pressure or density of a body tissue, characterized by using the bathing device (1), as defined in the first aspect, and by further comprising the following steps:

[0107] a) Compression of a sponge layer (2) onto the outer surface of a body tissue by a user; and

[0108] b) Measurement of changes in body tissue capacitance by the flexible capacitive electrode (4) based on the change in thickness of the sponge layer (2) as the sponge layer (2) is compressed by the user onto the outer upper part of the body tissue; and

[0109] c) Processing of data related to changes in capacitance, measured by body tissue using the flexible capacitive electrode (4), by a computational processing unit, obtaining parameters related to the pressure or density of the body tissue, and in which

[0110] Step c) concerning the processing of data related to capacitance changes includes identifying deviations from reference parameters for body tissue pressure or density and attributing these deviations to a clinical condition, and in which

[0111] Step c) is performed independently of steps a) and b) and is not performed while the bathing device (1) is in contact with body tissue.

[0112]

[0113] Preferably, in the computer-implemented method according to the invention, the data processing step related to capacitance changes is performed by at least one computational processing unit selected from the group consisting of a first computational processing unit (13) and a second computational processing unit (102); wherein

[0114] the first computational processing unit (13) is incorporated inside the waterproof casing (3) of the bathing device (1); and in which

[0115] the second computational processing unit (102) is included in the system (100) configured for measuring changes in the capacitance of a body tissue.

[0116]

[0117] As used in this description, the expressions "about" and "approximately" refer to a range of values ​​of plus or minus 10% of the specified number.

[0118] As used throughout this patent application, the term “or” is used in an inclusive sense rather than an exclusive sense, unless the exclusive sense is clearly defined in a specific situation. In this context, a sentence of the type “X uses A or B” should be interpreted as including all pertinent inclusive combinations, for example “X uses A”, “X uses B”, and “X uses A and B”.

[0119] As used throughout this patent application, the indefinite articles “a” or “an” should generally be interpreted as “one or more” and “an or more,” unless the meaning of a singular modality is clearly defined in a specific situation.

[0120] As presented in this description, terms related to examples should be interpreted as illustrating an example of something and not as indicating a preference.

[0121] As used in this description, the expression "substantially" means that the actual value is within approximately 10% of the desired value, variable, or related limit, particularly within approximately 5% of the desired value, variable, or related limit, or especially within approximately 1% of the desired value, variable, or related limit.

[0122] The subject matter described above is provided as an illustration of the present invention and should not be interpreted as limiting it. The terminology used to describe specific embodiments according to the present invention should not be interpreted as limiting the invention. As used in the description, definite and indefinite articles, in their singular form, are intended to include plural forms as well, unless the context of the description explicitly indicates otherwise. It will be understood that the terms "comprise" and "include," when used in this description, specify the presence of the related features, elements, components, steps, and operations, but do not exclude the possibility of other features, elements, components, steps, and operations also being contemplated.

[0123] All modifications, provided they do not alter the essential characteristics of the following claims, shall be considered within the scope of protection of the present invention.

[0124] 1. A bathing device configured to measure changes in the capacitance of a body tissue, for example human skin.

[0125] 2. A layer of sponge

[0126] 3. A waterproof covering

[0127] 4. A flexible capacitive electrode

[0128] 5. A second flexible capacitive electrode

[0129] 6. An electrical power supply unit

[0130] 7. A first data communication unit

[0131] 8. A second layer of sponge

[0132] 9. A side layer of sponge

[0133] 10. A complementary sensory unit

[0134] 11. An early printed circuit board

[0135] 12. A second printed circuit board

[0136] 13. A first computational processing unit

[0137] 14. A third printed circuit board

[0138] 15. A microcontroller

[0139] 16. A light indicator

[0140] 17. A screen

[0141] 18. An input / output (I / O) module

[0142] 19. An inertial measurement sensor

[0143] 20. A temperature sensor

[0144] 21. A humidity sensor

[0145] 22. An analog-to-digital converter

[0146] 23. A first integrated circuit

[0147] 24. A signal conditioning circuit

[0148] 25. A local signaler

[0149] 26. A feedback module

[0150] 27. A second integrated circuit

[0151] 100. A system configured for measuring changes in the capacitance of a body tissue, for example human skin.

[0152] 101. A computing device

[0153] 102. A second computational processing unit

[0154] 103. A second wireless data communication unit

[0155] 1000. Epidermis

[0156] 1001. Dermis

[0157] 1002. An anomaly

[0158] Patent document

[0159] U.S. patent application US20100162832A1 by Andreas Brauers, published on August 28, 2008.

Claims

A bathing device (1) configured to measure changes in the capacitance of a body tissue due to changes in the pressure or density of the body tissue, characterized by comprising: a sponge layer (2); and a waterproof casing (3); and a flexible capacitive electrode (4); and an electrical power supply unit (6); and a first data communication unit (7); and wherein the waterproof casing (3) is disposed over the sponge layer (2); and wherein the waterproof casing (3) encloses at least one flexible capacitive electrode (4), the electrical power supply unit (6) and the first data communication unit (7); and wherein the flexible capacitive electrode (4) is electrically powered by the electrical power supply unit (6) and is configured to transmit the measured data of the changes in the capacitance of the body tissue to the first data communication unit (7);and wherein the flexible capacitive electrode (4) is disposed on an inner lower surface of the waterproof enclosure (3) and wherein the inner lower surface of the waterproof enclosure (3) is disposed in a position adjacent to the upper surface of the sponge layer (2).; The bathing device (1), according to the preceding claim, characterized by a second layer of sponge (8) being disposed over the waterproof casing (3). The bathing device (1), according to the preceding claim, characterized by the waterproof casing (3) being enclosed by a foam casing. The bathing device (1), according to any of the preceding claims, characterized in that at least one of the group consisting of the sponge layer (2), the second sponge layer (8) and the foam wrap being impregnated with water or as an aqueous solution. The bathing device (1), according to any of the preceding claims, characterized by comprising at least one second flexible capacitive electrode (5); and wherein the waterproof casing (3) encloses the second flexible capacitive electrode (5); and wherein the second flexible capacitive electrode (5) is electrically powered by the electrical power supply unit (6) and is configured to transmit the measured data of changes in body tissue capacitance to the first data communication unit (7); and wherein the second flexible capacitive electrode (5) is disposed on an inner upper surface of the waterproof casing (3) and wherein the inner upper surface of the waterproof casing (3) is disposed in a position adjacent to the lower surface of the second sponge layer (8). The bathing device (1), according to any of the preceding claims, characterized by a plurality of flexible capacitive electrodes (4) being arranged longitudinally on the inner lower surface of the waterproof casing (3) and parallel to the upper surface of the sponge layer (2) and / or a plurality of second flexible capacitive electrodes (5) being arranged longitudinally on the inner upper surface of the waterproof casing (3) and parallel to the lower surface of the second sponge layer (8). The bathing device (1), according to any of the preceding claims, characterized by the flexible capacitive electrodes (4) being arranged in a support layer, wherein the support layer is arranged on an inner lower surface of the waterproof enclosure (3) and / or the second flexible capacitive electrodes (5) being arranged in a second support layer, wherein the second support layer is arranged on an inner upper surface of the waterproof enclosure (3). The bathing device (1), according to the preceding claim, characterized in that the support layer and the second support layer, wherein the second support layer is disposed on an inner upper surface of the waterproof enclosure (3), are selected from the group consisting of a flexible plastic film, a flexible printed circuit board, a film of an elastomer, a silicone film, a fabric, a nonwoven fabric, a conductive foam film, a sheet of impregnated technical paper, a film impregnated with at least one hydrogel, an adhesive tape, their laminates, combinations and composites. The bathing device (1), according to any of the preceding claims, characterized by the flexible capacitive electrodes (4) and / or the second flexible capacitive electrodes (5) being arranged in an interdigitated configuration. The bathing device (1), according to any of the preceding claims, characterized by the flexible capacitive electrodes (4) being incorporated into a first printed circuit board (11) and / or the second flexible capacitive electrodes (5) being incorporated into a second printed circuit board (12). The bathing device (1), according to any of the preceding claims, characterized by comprising at least one complementary sensory unit (10); and wherein the complementary sensory unit (10) is incorporated within the waterproof enclosure (3); and wherein the complementary sensory unit (10) is configured to transmit the measured data to the first data communication unit (6); and wherein the complementary sensory unit (10) includes at least one sensor selected from the group consisting of an inertial measurement sensor, a temperature sensor, a humidity sensor, a pressure sensor, a force sensor, an optical sensor, a pH sensor, a conductivity sensor, a touch sensor and a biometric sensor. The bathing device (1), according to any of the preceding claims, characterized by comprising a first computational processing unit (13); and wherein the first computational processing unit (13) is incorporated within the waterproof enclosure (3); and wherein the first computational processing unit (13) is configured to receive capacitance data from a body tissue transmitted by the first data communication unit (7), process said data and calculate the pressure or density of the body tissue. The bathing device (1), according to the preceding claim, characterized in that at least one of the group consisting of the sponge layer (2), the second sponge layer (8) and the foam wrap being impregnated with water or as an aqueous solution. A system (100) configured for measuring changes in the capacitance of a body tissue, characterized by comprising the bathing device (1), as defined in any of the preceding claims, and by further comprising: a computational device (101), which includes a second computational processing unit (102) and a second wireless data communication unit (103); and wherein the first data communication unit (7) of the device (1) is configured to transmit the data obtained by the flexible capacitive electrode (4) and / or the second flexible capacitive electrode (5) to the second wireless data communication unit (103); and wherein the second computational processing unit (102) is configured to process the body tissue capacitance data received by the second wireless data communication unit (103) and calculate the pressure or density of the body tissue. A computer-implemented method for calculating parameters related to the pressure or density of a body tissue, characterized by using the bathing device (1), as defined in any one of claims 1 to 13, and by further comprising the following steps: Compression of a sponge layer (2) onto the outer surface of a body tissue by a user; and Measurement of changes in the capacitance of the body tissue by the flexible capacitive electrode (4) based on the change in the thickness of the sponge layer (2) as the sponge layer (2) is compressed by the user onto the outer surface of the body tissue;eProcessing of data related to capacitance changes, measured by body tissue using the flexible capacitive electrode (4), by a computational processing unit, obtaining parameters related to body tissue pressure or density, and wherein step c) relating to the processing of data related to capacitance changes includes the identification of deviations from reference parameters for body tissue pressure or density and the attribution of said deviations to a clinical condition, and wherein step c) is performed independently of steps a) and b) and is not performed while the bathing device (1) is in contact with body tissue. The computer-implemented method according to the preceding claim, characterized in that the data processing step relating to capacitance changes is performed by at least one computational processing unit selected from the group consisting of a first computational processing unit (13) and a second computational processing unit (102); and in that the first computational processing unit (13) is incorporated inside the waterproof enclosure (3) of the bathing device (1); and in that the second computational processing unit (102) is included in the system (100) configured for measuring capacitance changes in a body tissue, as defined in claim 14.

Images