EP4355285A2 - Application compliance device - Google Patents

Application compliance device

Info

Publication number
EP4355285A2
EP4355285A2 EP22735143.4A EP22735143A EP4355285A2 EP 4355285 A2 EP4355285 A2 EP 4355285A2 EP 22735143 A EP22735143 A EP 22735143A EP 4355285 A2 EP4355285 A2 EP 4355285A2
Authority
EP
European Patent Office
Prior art keywords
signal
application compliance
compliance device
unit
care product
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP22735143.4A
Other languages
German (de)
French (fr)
Inventor
Eckhart Wildi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Merz Pharma Schweiz Ag
Original Assignee
Merz Pharma Schweiz Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Merz Pharma Schweiz Ag filed Critical Merz Pharma Schweiz Ag
Publication of EP4355285A2 publication Critical patent/EP4355285A2/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M35/00Devices for applying media, e.g. remedies, on the human body
    • AHUMAN NECESSITIES
    • A45HAND OR TRAVELLING ARTICLES
    • A45DHAIRDRESSING OR SHAVING EQUIPMENT; EQUIPMENT FOR COSMETICS OR COSMETIC TREATMENTS, e.g. FOR MANICURING OR PEDICURING
    • A45D34/00Containers or accessories specially adapted for handling liquid toiletry or cosmetic substances, e.g. perfumes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0077Devices for viewing the surface of the body, e.g. camera, magnifying lens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/44Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
    • A61B5/441Skin evaluation, e.g. for skin disorder diagnosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4833Assessment of subject's compliance to treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6887Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient mounted on external non-worn devices, e.g. non-medical devices
    • A61B5/6898Portable consumer electronic devices, e.g. music players, telephones, tablet computers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/74Details of notification to user or communication with user or patient ; user input means
    • A61B5/7475User input or interface means, e.g. keyboard, pointing device, joystick
    • A61B5/748Selection of a region of interest, e.g. using a graphics tablet
    • A61B5/7485Automatic selection of region of interest
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0076Medicament distribution means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0418Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with electronic history memory
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0427Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system
    • A61J7/0436Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system resulting from removing a drug from, or opening, a container
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0481Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers working on a schedule basis
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06TIMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T7/00Image analysis
    • G06T7/0002Inspection of images, e.g. flaw detection
    • G06T7/0012Biomedical image inspection
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/13ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered from dispensers
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • AHUMAN NECESSITIES
    • A45HAND OR TRAVELLING ARTICLES
    • A45DHAIRDRESSING OR SHAVING EQUIPMENT; EQUIPMENT FOR COSMETICS OR COSMETIC TREATMENTS, e.g. FOR MANICURING OR PEDICURING
    • A45D34/00Containers or accessories specially adapted for handling liquid toiletry or cosmetic substances, e.g. perfumes
    • A45D2034/002Accessories
    • AHUMAN NECESSITIES
    • A45HAND OR TRAVELLING ARTICLES
    • A45DHAIRDRESSING OR SHAVING EQUIPMENT; EQUIPMENT FOR COSMETICS OR COSMETIC TREATMENTS, e.g. FOR MANICURING OR PEDICURING
    • A45D44/00Other cosmetic or toiletry articles, e.g. for hairdressers' rooms
    • A45D2044/007Devices for determining the condition of hair or skin or for selecting the appropriate cosmetic or hair treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2576/00Medical imaging apparatus involving image processing or analysis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/002Monitoring the patient using a local or closed circuit, e.g. in a room or building
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/44Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
    • A61B5/441Skin evaluation, e.g. for skin disorder diagnosis
    • A61B5/445Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00General characteristics or adaptations
    • A61J2200/30Compliance analysis for taking medication
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00General characteristics or adaptations
    • A61J2200/70Device provided with specific sensor or indicating means
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06TIMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T2207/00Indexing scheme for image analysis or image enhancement
    • G06T2207/10Image acquisition modality
    • G06T2207/10024Color image
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06TIMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T2207/00Indexing scheme for image analysis or image enhancement
    • G06T2207/30Subject of image; Context of image processing
    • G06T2207/30004Biomedical image processing
    • G06T2207/30088Skin; Dermal

Abstract

The present invention relates to an application compliance device (1) for monitoring a customized dosage regime of a skin care product provided in a container device (20). The device comprises a housing (2) having an inner wall (2a) and an outer wall (2b), and defining a top opening (2c) with a first diameter (D1) for receiving the container device (20) in the application compliance device (1). The device further comprises a control unit (8), a sensor unit (10) configured to sense a quantity of the skin care product administered from the container device (20), when being received in the application compliance device (1), and a signal unit (7). The sensor unit (10) and the signal unit (7) are coupled to the control unit (8). The housing (2) houses the control unit (8), the sensor unit (10) and the signal unit (7). The control unit (8) is configured to evaluate a quantity signal received from the sensor unit (10) to determine an administered dosage quantity, to control the signal unit (7) to generate a compliant signal if the administered dosage quantity is compliant with the customized dosage regime, to control the signal unit (7) to generate a partly compliant signal if the administered dosage quantity is not compliant with the dosage regime for a first time, and to control the signal unit (7) to generate a warning signal if the administered dosage quantity is not compliant with the dosage regime for a second time. The invention also relates to a method of monitoring such a customized dosage regime and to methods for determining a therapy surface on a patient's skin.

Description

DESCRIPTION
Title
APPLICATION COMPLIANCE DEVICE
Technical Field
[0001] The present invention relates to an application compliance device for monitoring a customized dosage regime of a skin care product and a method of monitoring a customized dosage regime for a skin care product provided in a container device.
Background Art
[0002] In the treatment of many skin diseases there is an existing need of providing a customized dosage regime in order to be able to carry out a consequent and efficient basic therapy. For example, in the treatment of the atopic or xerotic eczema it was found that a consequent basic therapy comprises a particularly high level of importance.
[0003] The xerotic eczema is a form of eczema that is characterized by changes that occur when skin becomes abnormally dry, red, itchy, and cracked. It tends to occur more often during the winter and in dry conditions. The lower legs tend to be especially affected; however, it can appear in the underarm area as well. The xerotic eczema is common in elderly people, although also people in their twenties may be affected. During treatment of the xerotic eczema it is usually attempted to re-hydrate the dry skin by using liquid or semi-solid humidifiers such as medical skin oils.
[0004] The atopic eczema is usually a chronic condition with itchy, dry, cracked and scored skin on small patches or widespread all over the body. Flares of inflamed and often red skin affect predominantely hands, inner elbows, backs of knew and the face.
[0005] It is a prerequisite that patients are instructed comprehensively and motivated for carrying out a basic therapy. Patients shall be aware that the basic therapy is a cornerstone of the therapy which may reduce intensity and duration of the acute phases. Yet, it is not everybody’s cup of tea to undergo an intensive skin care program. [0006] Typically, women may be convinced more easily than men. Further, with regard to elderly patients, particular emphasis has to be put on a comprehensive basic care due to the already drier skin.
[0007] An exemplary dosage regime includes for instance applying at the upper extremities two pump hubs of a medical skin oil from a dispenser per side in the morning and in the evening and at the lower extremities three pump hubs per side. It goes without saying that the dosage regime has to be discussed with a doctor in view of the affected body parts.
[0008] However, also in the application of cosmetic skin care products, a need exists for providing a customized dosage regime in order to achieve a satisfactory success in application. Respective cosmetic skin care products which are currently on market comprise e.g. all sorts of lotions, creams, sera, pastes, gels, liquids and the like. Usually, the commercially available cosmetic skin care products are marketed and provided to users without any specifications which would take into consideration the individual skin conditions of different users. Furthermore, also here, it is usually the best guarantee for an effective treatment if the application of the respective skin care product is carried out consequently, i.e. according to a pre-defined dosage regime.
[0009] A known medication adherence apparatus is shown and described in US 2020/0113787 A1. The medication adherence apparatus comprises a container element operably coupled to a cap device, wherein the cap device obtains a weight of the container element, an orientation of the cap device, a temperature of the cap device, and a time stamp including a day, time, and date. The weight of the container element is obtained by a force sensor when the container element is inserted into the cap device. Further, a connection of a top connecting portion of the container element in a threaded interior portion of the cap device is detected by the cap device. The orientation of the cap device is detected to determine if the cap device and the container element is upright generally along a vertical axis. Also, any movements along the vertical axis, a longitudinal axis, or a lateral axis are detected. The cap device receives a medication schedule and notification parameters to notify a patient by an alarm if medication is missed.
[0010] Such an electric dispenser which takes measurements at the container opening involves the risk of contaminations, especially when medical products are to be applied. [0011 ] Further, the above solution does not provide for the possibility of using containers of different sizes which may be put into the housing of the device and the primary packaging of which, being in contact with the liquid or semi solid product, remaining unaltered.
[0012] It is therefore the object of the present invention to allow an efficient monitoring of a compliant dosage regime of applying a skin care product and to provide for a variable and efficiently operable application compliance device or method.
Disclosure of the Invention
[0013] According to the invention these needs are settled by an application compliance device as it is defined by the features of independent claim 1 and a method as it is defined by the features of independent claim 19. Preferred embodiments are subject of the dependent claims.
[0014] In one aspect, the present invention is an application compliance device for monitoring a customized dosage regime of a skin care product provided in a container device. Generally, the term “skin care product” refers to all sorts of medical and cosmetic skin care products, as for example oils, liquid soaps, lotions, creams, sera, pastes, gels, liquids and so forth. The term “container device” generally refers to all sorts of containers from which may provide the skin care product. Advantageously, the container devices allow for preventing the skin care products from getting into contact with the container device or components thereof, as is the case for example with containers having a conventional top opening or with dispenser devices having a dispenser pump at the top.
[0015] The application compliance device comprises a housing having an inner wall and an outer wall, and defining a top opening configured to receive the container device in the application compliance device. The top opening of the housing can be configured to receive the container device by having an inner boundary corresponding to the outer boundary of the container device. For example, it can have an inner cross-sectional geometry fitting to an outer cross-sectional geometry of the container device. Preferably, the top opening defines a first diameter. As described in more detail below, the top opening of the housing can also be configured to receive the container device via a collar element mounted to the top opening, i.e. indirectly receiving the container device. [0016] The application compliance device further comprises a control unit, a sensor unit configured to sense a quantity of the skin care product administered from the container device when being received in the application compliance device, and a signal unit. The sensor unit and the signal unit are coupled to the control unit. The term “coupled” in this connection may relate to connection achieving the sensor and signal units being in communication with the control unit. Such coupling may be achieved by electrical connection means, as for example electric wires, electric leads, electric lines, electric cables and so forth. Also, all sorts of wireless communication are conceivable.
[0017] The housing houses the control unit, the sensor unit and the signal unit. Like this, these components can be protected in the housing and the housing may assure proper positioning of the container device relative to these components, when the container device is received in the application compliance device.
[0018] The control unit is configured to evaluate a quantity signal received from the sensor unit to determine an administered dosage quantity, to control the signal unit to generate a compliant signal if the administered dosage quantity is compliant with the customized dosage regime; to control the signal unit to generate a partly compliant signal if the administered dosage quantity is not compliant with the customized dosage regime for a first time; and to control the signal unit to generate a warning signal if the administered dosage quantity is not compliant with the customized dosage regime for a second time.
[0019] The term “signal” as generated by signal unit under control of the control unit may be any visual, acoustic or other signal conceivable by the user or patient. Advantageously, the signals are optical or visual signals such as color displayed. For example, the signal unit can be configured to generate the compliant signal by providing a green illumination, to generate the partly compliant signal by providing an orange illumination and to generate the warning signal by providing a red illumination. Thereby, the signal may be constantly provided or periodically or the like. One of the signals may also be provided by the signal unit not providing any illumination. For example, the compliant signal may be generated by not providing any illumination but only in case an at least partly non-compliance is detected an illumination is generated.
[0020] A “customized dosage regime” may be tailored to the individual needs of a specific medication or therapy. It may comprise a (pre-defined) necessary dosage quantity of the skin care product which the user or patient has to apply per single use, the number of single uses per day or at certain dates, and the respective times or time intervals of the day at which or during which compliance shall be monitored. The dosage quantity and a respective application time scheme are set depending on the nature of the specific skin disease/irritation, the size of the affected skin portions and/or the age and the gender of the user. Thus, usually, the customized dosage regime is set up by a doctor for the patient. However, the application compliance device may be preconfigured for a specific therapy of the patient may input an appropriate dosage regime in accordance with a package leaflet or the like.
[0021] For example, the customized dosage regime may comprise a first application time (or time interval) in the morning and a second application time (or time interval) in the evening, i.e. where a (pre-defined) dosage quantity has to be applied in order to be compliant. Between the first application time (or time interval) and the second application time (or time interval) there may be provided a monitoring time (or time interval) where it is monitored whether a non-administered dosage quantity (e.g. in the morning) has been administered retrospectively. Usually, the daily dosage retains this frequency. Yet, the daily dosage may be variable with regard to the dosage quantity.
[0022] The term “time” in connection with the first time and the second time may relate to a point in time such as a clock time or to a time interval such as a number of hours, minutes or the like. Also, combinations of a point in time and a time interval are possible. For example, the first time may be set as 8.00 in the morning and the second time as 19.00 in the evening. With such setting, the application compliance device can monitor if the patient applies a specific dosage quantity in the morning and in the evening. By providing two different signals, the patient can be reminded of the failed administration, e.g. in the morning, and give the opportunity to correct the administration by the evening. In this example, the control unit preferably is equipped with a clock. In another example, the first time can be set as 12 hours and the second time as 24 hours. In such embodiment, starting for the begin of the therapy, e.g. simply by positioning the container device into the application compliance device and triggering with that move a switch (preferably an integrated on/off switch) to start the timer and the treatment schedule, it can be monitored if the patient regularly or periodically applies a correct dosage quantity. This simple manual trigger-step by placing the container device into the application compliance device allows the patient to commence a treatment regime which will start every day in the morning at the same time. Overall, this will lead presumably to a much higher compliance because the patient sets the initial morning time and from that moment on has to comply every day to a strict schedule. Thereby, if the patient fails to apply the dosage quantity within the first time interval, i.e. 12 hours, he is remined by the partly compliant signal and may be allowed to correct the failed application, and if he fails to apply the dosage quantity within the second time interval as well, he is warned by the warning signal.
[0023] At the first and second time it is also monitored whether the pre-defined necessary dosage quantity has been administered. For example, if the user or patient applies the necessary dosage in the morning and in the evening, the compliant signal is generated. If the user misses the application in the morning (i.e. for a first time) or does not apply the necessary dosage quantity, the partly compliant signal is generated at the monitoring time in order that the user is reminded (e.g. at midday) to apply the necessary dosage quantity retrospectively. If the user misses the application also at midday (i.e. for a second time), a warning signal is generated at the second application time in the evening in order that the user is warned that he neglects the therapy.
[0024] Preferably, the compliant signal is in the form of a green light, the partly compliant signal is in the form of a yellow light and the warning signal is in the form of a red light. Thus, the signal unit of the inventive device may comprise a traffic light appearance. In other words, the green light indicates a correct application in accordance with the customized dosage regime, the yellow light indicates an overdue application, i.e. the application has not been carried out in accordance with the dosage regime and the red light warns that the application has been neglected.
[0025] Preferably, the customized dosage regime is input into the control unit of the inventive device, respectively.
[0026] Preferably, the device further comprises at least one collar element adapted to be inserted into the top opening of the housing. Such collar element allows for adapting the opening or its shape to the specific container device used. For example, the shape of the opening can be adapted to correspond or fit to the container device used. Like this, the application compliance device can be used with different container devices such as different sized container devices of the same skin care product. In order to selectively use the application compliance device with different specific container devices, the at least one collar element comprises a plurality of collar elements or a set of collar elements.
[0027] Preferably, the top opening of the housing has a first diameter, the at least one collar element defines a collar opening with a second diameter adapted to receive a specific container device (preferably containing a skin care product) and the at least one collar element has one or more engagement portions which interact with one or more corresponding engagement portions of the inner wall of the housing. Advantageously, collar elements with varying diameters for receiving varying containers/container sizes may be provided.
[0028] The engagements portions and corresponding engagement portions may be any structure allowing for reversibly mounting collar element to the housing. For example, the engagements portions and corresponding engagement portions can be embodied for a clamping connection, a snap-fit connection a screwing connection or the like. Preferably, the one or more engagement portions of the collar element comprise a flexible tongue. Advantageously, two or four flexible tongues are provided which engage with or snap into a correspondingly shaped curvature which forms the one or more engagement portions of the housing inner wall. The one or more corresponding engagement portions of the housing inner wall may also include edges, protrusions and the like. The engagement portions of the collar element and of the housing inner wall may also be configured to provide a purely form-fit connection.
[0029] Preferably, the second diameter of the collar opening is smaller than the first diameter of the top opening of the housing. In this manner, different sorts, sizes and shapes (e.g. round, oval, square or rectangular) of collar elements for corresponding sorts, sizes and shapes of containers/dispensers may be used in connection with one and the same housing. It is noted that the housing shapes may also vary in a corresponding manner.
[0030] Thereby, the collar element preferably comprises an inner wall element which at least partially encloses the dispenser and an outer wall element in which e.g. the flexible tongues are arranged and which provides for a stable seat of the collar element within the housing and thus improves the measuring accuracy. Further preferably, the housing may include a circumferential top inner wall portion which corresponds to the outer wall portion of the collar element. In this manner it is ensured that the container/dispenser does not jiggle within the device which contributes to precise measurements. Further, by providing a close fit for the container/dispenser in the collar element, the appropriate container/dispenser size is immediately apparent for the user.
[0031] Preferably, the collar element comprises a flange portion which limits the collar element in the upward direction. The flange portion may have a flat surface or a rounded surface. The flange portion may be flush with the housing outer wall in the assembled state or it may protrude somewhat over the outer wall of the housing such that it may be exchanged more easily.
[0032] Preferably, the variable collar elements (as well as the housing) may be formed of plastics material, e.g. by means of 3D-printing or by means of injection molding. The plastics material may be at least partially transparent.
[0033] Preferably, the device comprises a battery-operated power supply being arranged within the housing. In this manner, the device may be placed in any desired location in an autonomous manner.
[0034] The control unit may generally be any typically electronic structure allowing for configuring and controlling the application compliance device. It may include known means for being appropriately configures such as processor, a memory, a data storage or the like. Also, the control unit can be equipped with an interface structure for receiving or providing command and/or information to other components, devices and/or an operator. The control unit may be a single physical instance, a multi component construction or a distributed system.
[0035] Preferably, the control unit is programmable and comprises one or more computer programs and/or algorithms. The programmable control unit may synchronize data within the scope of a computer program and/or within the scope of one or more algorithms with pre-defined target values and which may transfer this synchronization through data signals respectively through wireless transfer to a mobile device, i.e. a smartphone, a smartwatch, a tablet computer or a lap top computer or the like.
[0036] Preferably, there is provided on the control unit a program with algorithms which allows weighing a container/dispenser during initial inserting and thus identify the latter and then to further monitor the course of the respective therapy and to recognize when the user forgets to insert again the container/dispenser or wrongly inserts the container/dispenser or if the user applies to much pressure on the device when for example pumping a skin care product from a dispenser.
[0037] Preferably, the control unit comprises a real-time clock such that it may precisely determine respectively monitors for the user the respective daytimes and/or time intervals and/or dates of a customized dosage regime and also transfer the latter in a wireless manner to a mobile device.
[0038] Further preferred, the control unit comprises a programmed standby operation which ensures that the device may be applied in an energy saving manner and therefore may be operated in an autonomous manner for the whole duration of a therapy (e.g. usually 3 to 4 weeks).
[0039] The sensor unit may include any type of sensing structure allowing to identify or measure a quantity of the skin care product administered from the container device. For example, the sensor unit may be equipped with a pressure sensor to measure a pressure inside the container device or a flow meter allowing for determination of a skin care product flow out of the container device.
[0040] Preferably, the sensor unit comprises a weighing sensor. Such weighing sensor allows for determining a weight of the container device received in the application compliance device. By comparing the weight of the container device before and after an administration or during the first or second time, the dosage quantity can be determined.
[0041] Advantageously, the weighing sensor has a sensor body and a weighing plate adapted to be mounted to the sensor body. Thereby, the weighing plate may comprise a mounting element adapted for mounting the weighing plate to the sensor body. The mounting element may for example be in the form of a screw by means of which the weighing plate is screwed into the sensor body. When inserted into the inventive device, the container/dispenser is placed with its bottom surface onto the weighing plate.
[0042] The weighing sensor may operate very precisely and may measure dosages in the milligram range. The weighing sensor may output data in an analogue or digital manner. In contrast to a pressure sensor, the weighing sensor may not be influenced by wrong measured values which may occur when the user has to exert an increased pressure on the dispenser during use since, for example, a viscous formulation in the dispenser has dried out. [0043] It is further noted that in configuration with a weighing sensor, the quantity signal is a weight signal. The control unit can then determine the administered dosage quantity by evaluating the weight before and after administration. Since the sensor unit having the weighing sensor can efficiently be embodied not to get into direct contact with the content of the container/dispenser, i.e. the skin care product, there is no risk of contamination. Also, a potential clogging of the device may be prevented in this manner.
[0044] Preferably, the application compliance device comprises a converter unit coupled to the control unit and housed by the housing. The converter unit may comprise an A/D converter adapted to amplify an analogue signal and to digitally convert the analogue signal. The use of an A/D converter contributes to a precise and efficient functioning of the inventive device.
[0045] Preferably, the signal unit comprises one or more light-emitting diodes (LED). Like this, the signal unit may efficiently provide visual or optical signals. The whole application compliance device may be highly visible as a signal transmitter with pre-programmed colors and flash sequences. For instance, the light signals produced by the light-emitting diodes may be in the kind of a traffic light, i.e. with green, red and yellow light signals and/or flash sequence. It is however also conceivable that the signal unit sends out acoustic and/or tactile signals.
[0046] Preferably, the device further comprises an integrated on/off switch. The on/off switch is preferably integrated into the housing of the device. Advantageously, the on/off switch is configured to be activated when the container device is inserted into the application compliance device. It is also conceivable that the on/off switch is configured to be deactivated when the container device is removed from the application compliance device. For example, the integrated on/off switch can be formed in such a way that the user, when inserting a container/dispenser into the device for the first time, triggers the weighing mechanism - e.g. when placed on the weighing plate - and a respective time schedule for a customized dosage regime and does not need to take any further measures subsequently. It is also conceivable that a restoring function resets the weighing mechanism respectively the weighing plate when removing the container from the application compliance device.
[0047] Preferably, the housing further includes a base plate having a receiving structure adapted to receive the control unit, the sensor unit, the converter unit, the signal unit and/or the integrated on/off switch. In this manner, a particularly compact and stable assembly may be achieved.
[0048] Preferably, the device further comprises a support plate arranged within the housing and, optionally, having through openings for receiving and/or holding the signal unit, the mounting element of the weighing plate and/or the integrated on/off switch. This further contributes to the compactness of the assembly and may also provide for a precise fit respectively holding arrangement of the light-emitting diodes and the integrated on/off switch. The support plate is arranged in the housing between the collar element and the base plate and may be provided with support structures which correspond to the receiving structures of the base plate to ensure a precise mounting.
[0049] Preferably, the housing comprises a sealing to the outside such that the device may also be placed in locations with a relatively high humidity.
[0050] Preferably, the housing outer wall comprises a punched-out cover element adapted to receive different labels indicating the skin care product to be administered. Further preferred, the punched-out cover element is releasably mounted at the outer wall of the housing. The punched-out portion(s) of the cover element may be in the form of a logo such that for example colored labels representing different skin care products of one manufacturer may be inserted into the punched-out cover element. In this manner, a clear allocation may be provided for the user preventing confusion if for instance more than one device with two different products are in parallel use.
[0051] Preferably, the customized dosage regime is defined in the control unit by setting a necessary dosage quantity and a time scheme comprising the first time and the second time.
[0052] Preferably, the control unit is configured to identify if the administered dosage quantity is compliant with the customized dosage regime by comparing the administered dosage quantity to the necessary dosage quantity.
[0053] The application compliance device may be integrated in an inventive skin therapy system. The system comprises one or more devices communicating with the application compliance device. For example, the system may comprise configuration device such as a computer or mobile device, configured to configurate the application compliance device. Thereby, the configuration device may communicate via an interface structures with the application compliance device. For example, the configuration device may allow for setting the dosage regime or parameters thereof in the application compliance device. This allows an operator to customize and the application compliance device to be appropriate for a specific therapy of a specific skin care product provided in a specific container device.
[0054] The system may also comprise a server device which can be connected to the application compliance device. Thereby, the application compliance device may be embodied to transfer data about a therapy to the server device. This may happen in real time or the application compliance device may be embodied to store the therapy data and to provide at a certain point in time to the server device.
[0055] Communication between the one or more devices of the system may be provided wirelessly or by physically connecting the devices together. Also, the communication can be embodied via the Internet or the like.
[0056] In another aspect, the invention is a method of monitoring a customized dosage regime for a skin care product provided in a container device. The method comprises obtaining an application compliance device according to the invention, positioning the container device in a housing of the application compliance device such that the container device is accessible to a senor unit of the application compliance device. Further, the senor unit of the application compliance device senses a quantity of the skin care product inside the container device. The control unit of the application compliance device evaluates a quantity signal received from the sensor unit to determine an administered dosage quantity. The method further comprises generating a signal if the administered dosage quantity is compliant with the customized dosage regime, generating a partly compliant signal if the administered dosage quantity is not compliant with the customized dosage regime for a first time, and generating a warning signal if the administered dosage quantity is not compliant with the customized dosage regime for a second time.
[0057] Preferably, the method comprises a step of defining the customized dosage regime by setting a necessary dosage quantity of the skin care product to be administered and a time scheme comprising the first and second time.
[0058] The compliant signal is preferably in the form of a green light, the partly compliant signal may be a yellow light and the warning signal may be a red light. Thus, the signal unit of the inventive device may comprise a traffic light function. In other words, the green light indicates a correct application in accordance with the dosage respectively therapy regime, the yellow light indicates an overdue application, i.e. the application has not been carried out in accordance with the dosage regime and the red light warns that the application has been neglected.
[0059] In a preferred embodiment of the method, the customized dosage regime comprises a daily time scheme with at least a first application time interval, a second application time interval and a reminder time interval between the first application time interval and the second application time interval. The preferred method comprises: verifying at the first application time interval whether the necessary dosage quantity of the skin care product has been administered and generating a compliant signal in the positive event, or generating a partly compliant signal at the reminder time interval in the negative event; (b) optionally, verifying at the reminder time interval whether a left out dosage quantity of the skin care product at the first application time interval has been administered retrospectively and generating a partly compliant signal in the positive event, or generating a warning signal at the second application time interval in the negative event; (c) verifying at the second application time interval whether the pre defined necessary dosage quantity of the skin care product has been administered and generating a compliant signal at the first application time interval of the following day in the positive event, or generating a partly compliant signal or a warning signal at the first application time interval of the following day in the negative event.
[0060] According to this method, no data has to be stored in the control unit (i.e. except from the necessary dosage quantity) and each day starts at the same time but independently, i.e. the initial signal value corresponds to the last signal value of the previous day. An exemplary dosage regime according to this method is described further below in connection with the figures.
[0061 ] In a further other aspect, the invention is a method for an interactive determination of a therapy surface on a patient’s skin and of a necessary dosage quantity of a respective skin care product for treating the therapy surface, the method comprising the steps: (a) providing a mobile device with an image grid function means, the image grid function means being adapted for activating on the display of the mobile device one or more grid fields which represent potentially affected skin portions of a patient and for calculating a value for a necessary dosage quantity of the skin care product on the basis of the activated grid field(s); (b) activating on the display of the mobile device one or more grid field(s) representing affected skin portion(s) of the patient; (c) calculating a value for a necessary dosage quantity of the skin care product based on the activated grid field(s); (d) transferring the calculated value for the necessary dosage quantity of the skin care product to a control unit of, preferably, the inventive application compliance device. In other words, the calculated value may be transferred to the inventive application compliance device, but it may also be transferred to another appropriate application compliance device.
[0062] Preferably, the mobile device is connected to the application compliance device in a wireless manner.
[0063] Preferably, the image grid function means is provided on the mobile device in the form of an App.
[0064] According to this method, the user and/or the doctor are enabled to (manually) activate the affected skin portions on the mobile device by means of the image grid such that the app may then calculate the necessary dosage quantity.
[0065] Preferably, the necessary dosage quantity is a daily necessary dosage quantity which may be divided in two or more individual applications per day.
[0066] The daily necessary dosage quantity preferably represents a number of hubs which correspond to the activated grid fields of the image grid functions means. Thereby, one grid field may represent one or more pump hubs of the skin care product.
[0067] The image grid function means may then inform the user how many hubs of the respective skin care product he has to apply to each affected skin portion per day or per individual application time and the inventive device may monitor whether the prescribed dosage quantity is administered in accordance with a pre-defined time scheme.
[0068] Advantageously, the image grid function means comprises storing the collected data and evaluating the collected data over the entire treatment period such that the course of the skin change or skin disease may be monitored continuously in connection with the treatment adherence and may, if necessary, be sent to the attending doctor.
[0069] In still another aspect, the invention is a method for an interactive determination of a therapy surface on a patient’s skin and of a necessary dosage quantity of a respective skin care product for treating the therapy surface, the method comprising the steps: (a) providing a mobile device having a camera with an image recognition function means, the image recognition function means being adapted for detecting and measuring one or more affected skin portion(s) of a patient and for calculating a value for a necessary dosage quantity of the skin care product for the affected skin portions; (b) detecting and measuring one or more affected skin portion(s) by using the camera of the mobile device; (c) calculating a value for a necessary dosage quantity of the skin care product for the affected skin portion(s); (d) transferring the calculated value for the necessary dosage quantity of the skin care product to a control unit of, preferably, the inventive application compliance device. In other words, the calculated value may be transferred to the inventive application compliance device, but it may also be transferred to another appropriate application compliance device.
[0070] The image recognition function may detect by means of the camera of the mobile device and specific image filters or algorithms (e.g. Open Broadcaster Software can be used already to extract certain colours or alpha channel information of an image which then can be analyzed) which kind of pathological skin change or disease exists on the user’s skin and may measure the size respectively surface of the affected skin portion. In other words, the image recognition function means may calculate a necessary dosage quantity for different skin care products used for different skin changes/skin diseases.
[0071 ] In particular, the image recognition function may detect affected skin portions of a patient by means of the camera of the mobile device. The validity of the quantitative measurement of the affected skin portion shell be accomplished by applying, as indicator- lotion, a contrasting component with colour, thermal and/or reflective effects or pigments on the skin beforehand, as for example to the crook of the arms. The patient or the medical doctor or the medical caregiver only have to apply such a indicator formulation once at the affected skin portions for calibration purposes. The cream may be fluorescing, thermal and/or reflecting. This calibration procedure (i.e. for the image recognition function means) shall be done before the treatment regime commences and shell be repeated preferably after a certain period of time. This calibration procedure allows unambiguously the quantitative measurement of the affected skin, avoiding any misinterpretations of skin portions which return wrong light signals due to shadowing or bright light reflections or optical colour-shiftings. [0072] The indicator lotion generally includes chemical additives with striking colors or thermal or reflection properties which a smartphone camera sensor can measure unambiguously, irrespective of the intensity and angle of the external light source (including artificial light, dim light, shadows etc.). These chemicals should be safe for short-term topical application and should be missible with oil in water emulsions or water in oil emulsions.
[0073] The affected skin portions should be monitored at least after three to four weeks, eventually also during intermediate stages.
[0074] Preferably, the mobile device is connected to the application compliance device in a wireless manner.
[0075] Preferably, the image recognition function means is provided on the mobile device in the form of an App.
[0076] Advantageously, this App may be included in the App used in connection with the previous embodiment (i.e. with the image grid function mode) and thus form a combined App respectively a system which may be provided on a mobile phone. In other words, when using the (combined) App respectively system, the user can decide whether he wants to apply the image grid function mode or the image recognition mode.
[0077] Advantageously, the image recognition function means comprises storing the collected data and evaluating the collected data over the entire treatment period such that the course of the skin change or skin disease may be monitored continuously in connection with the treatment adherence and may, if necessary, be sent to the attending doctor.
[0078] Brief Description of the Drawings
[0079] The application compliance device according to the invention as well as the inventive methods are described in more detail herein below by way of exemplary embodiments and with reference to the attached drawings, in which:
Fig. 1 shows a perspective view of the inventive application compliance device in the assembled state with introduced skin care product container;
Fig. 2 shows an exploded view of the inventive application compliance device; Fig. 3 shows a perspective view of the underside of the inventive collar element;
Fig. 4 shows a perspective view of the base plate of the inventive application compliance device with electric components;
Fig. 5 shows an exemplary schematic illustration of an inventive therapy scheme; and
Fig. 6 shows an exemplary schematic illustration of a mobile device with an inventive image grid function means.
Description of Embodiments
[0080] In the following description certain terms are used for reasons of convenience and are not intended to limit the invention. The terms “right”, “left”, “up”, “down”, “under" and “above" refer to directions in the figures. The terminology comprises the explicitly mentioned terms as well as their derivations and terms with a similar meaning. Also, spatially relative terms, such as "beneath", "below", "lower", "above", "upper", "proximal", "distal", and the like, may be used to describe one element's or feature's relationship to another element or feature as illustrated in the figures. These spatially relative terms are intended to encompass different positions and orientations of the devices in use or operation in addition to the position and orientation shown in the figures. For example, if a device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be "above" or "over" the other elements or features. Thus, the exemplary term "below" can encompass both positions and orientations of above and below. The devices may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein interpreted accordingly. Likewise, descriptions of movement along and around various axes include various special device positions and orientations.
[0081 ] To avoid repetition in the figures and the descriptions of the various aspects and illustrative embodiments, it should be understood that many features are common to many aspects and embodiments. Omission of an aspect from a description or figure does not imply that the aspect is missing from embodiments that incorporate that aspect. Instead, the aspect may have been omitted for clarity and to avoid prolix description. In this context, the following applies to the rest of this description: If, in order to clarify the drawings, a figure contains reference signs which are not explained in the directly associated part of the description, then it is referred to previous or following description sections. Further, for reason of lucidity, if in a drawing not all features of a part are provided with reference signs it is referred to other drawings showing the same part. Like numbers in two or more figures represent the same or similar elements.
[0082] Fig. 1 shows a perspective view of the inventive application compliance device 1 in the assembled state with an introduced skin care product container 20. The skin care product container 20 comprises a cap 21 and a body 22. The container 20 allows removing the skin care product without getting into contact with the device 1 or components thereof. The container 20 thus preferably comprises a cap and/or opening as used for instance in conventional lotion or sun cream containers or a pumping equipment as used e.g. for conventional liquid soap dispensers.
[0083] The inventive application compliance device 1 comprises a housing 2 with an outer wall 2b, a collar element 3 with a flange portion 3a having a width Wf and a bevel 3e which provides for a flush mounting with the housing 2. A base plate 4 forms the bottom of the device 1 respectively of the housing 2. On the outer wall 2b of housing 2 there is arranged a punched-out cover element 5 with three exemplary punched-out portions or letters 5a. The punched-out cover element 5 is adapted to receive different labels (e.g. with different colors) which shall indicate to the user which skin care product shall be administered. Further preferred, the punched-out cover element 5 is releasably mounted at the outer wall 2b of the housing 2. The punched-out portions 5a of the cover element 5 may be in the form of a firm logo such that for example colored labels representing different skin care products of one manufacturer may be inserted into the punched-out cover element 5. The outer wall 2b of housing 2 may be straight or slightly convex and the bevel 3e of the collar element 3 respectively conforms to the housing outer wall 2b.
[0084] In Fig. 2, an exploded view of the inventive application compliance device 1 is illustrated. As one can see, the collar element 3 defines a collar opening 3b with a diameter D2 which is smaller than the diameter Di of the housing top opening 2c. The difference between the two diameters (D1-D2) substantially corresponds two times the width Wf of flange portion 3a (of. Fig. 1 ). Between outer wall portions 3d of collar element 3 there are arranged flexible tongues 3c which engage with corresponding structures of the housing inner wall 2a (not shown). For example, two or four flexible tongues 3c may be provided which engage with or snap into a correspondingly shaped curvature of the housing inner wall 2a. The housing inner 2a wall may also comprise correspondingly shaped edges, protrusions and the like.
[0085] On the base plate 4 and/or on its respective receiving structure 4a, an control unit 8, a sensor unit 10, a converter unit 9, four signal units 7 with light-emitting diodes 7a and an integrated on/off switch 12 are arranged in a somewhat disassembled state wherein the control unit 8, the sensor unit 10, the converter unit 9, the four signal units 7 and the switch 12 are electrically interconnected by means of conventional electrical interconnections 11 . The electrical control unit 8 comprises a connection element 8a for external devices, as for example a smartphone or smartwatch, a tablet computer or a laptop computer or a personal computer. The electrical control unit 8 may of course also be connected with such devices in a wireless manner.
[0086] Support plate 6 is arranged within the housing 2 between the base plate 4 and the collar element 3. The support plate 6 has openings 6a which are adapted to receive and hold the light-emitting diodes 7a of the four signal units 7. Further, the support plate 6 comprises an opening 6b through which integrated on/off switch 12 shall slightly protrude in the initial state. Also, the support plate 6 has an opening through which mounting element 10b for the weighing plate 10a may protrude.
[0087] Fig. 3 shows a perspective view of the underside of an inventive collar element 3. Arranged between the outer wall portions 3d are two flexible tongues 3c which are adapted to engage with correspondingly shaped engagement structures of the housing inner wall 2a. The outer wall portions 3d provide for a stable seat of the collar element 3 within the housing 2. The two lateral apertures 3g between outer wall portions 3d shall provide for some degree of flexibility for the insertion of the collar element 3 and for supporting the latter within the housing 2. The inner wall 3f of the collar opening 3b shall preferably enclose the body 22 of the container 20 in such a way that no jiggling of the container 20 in the device 1 may occur. Both, the inner wall 3f and the outer wall portions 3d protrude beyond bevel 3e.
[0088] Fig. 4 depicts a perspective detailed view of the base plate 4 of the inventive application compliance device 1 with the electric components, namely the control unit 8, the sensor unit 10, the converter unit 9, the four signal units 7 with light-emitting diodes 7a, and the integrated on/off switch 12 in a somewhat disassembled state. In this embodiment, the control unit 8, the sensor body 10d, the converter unit 9 and the integrated on/off switch are arranged on the receiving structure(s) 4a of the base plate 4. Further, receiving structure may also be provided for batteries (not shown) such that the device 1 may be operated autonomously.
[0089] As one can see, integrated on/off switch 12 is mounted in a guide 12b of the receiving structure 4a and may be operated in a vertical manner (see arrow). Here, the switch 12 is in the pressed-down position which is achieved when a container 20 is introduced for the first time in the housing 2 of the device 1 and presses down the weighing plate 10a and the support plate 6 with the opening 6b through which the switch 12 (respectively its topside 12a) slightly protrudes in the initial state (i.e. in the assembled state with switch 12 in the upper position).
[0090] Further, sensor body 10d of sensor unit 10 comprises a bore 10c for receiving (preferably screwing in) the mounting element 10b of the weighing plate 10a.
[0091] An exemplary customized dosage regime is illustrated in the scheme in Fig. 5. The scheme prescribes that a pre-defined necessary dosage quantity shall be applied at a first application time interval between 7:00 and 8:00 a.m. (morning) and that another pre-defined necessary dosage quantity (preferably the same quantity) shall be applied between 6:00 and 7:00 p.m. (evening). The time scheme also includes a reminder time interval between 12:00 and 1 :00 p.m. (midday) where it is verified if the first necessary dosage quantity was left out.
[0092] The arrows in the scheme indicate that the pre-defined necessary dosage quantity has been administered. Further, in the scheme “co” stands for “compliant” (which indicates a correct application in accordance with the scheme, and is connected with a green light signal of the signal unit), “pco” stands for “partly compliant” (which indicates that an application is overdue respectively left out once, and is connected with a yellow light signal of the signal unit) and “w” stands for “warning” (which indicates that the application has been neglected respectively left out twice, and is connected with a red light signal of the signal unit). Thus, the inventive device comprises a traffic light function.
[0093] It is noted that according to this scheme no data is stored and every day starts at the same time (i.e. 7:00 a.m.) but independently from the previous day; i.e. the initial signal corresponds to the last signal of the previous day). [0094] On day A, the patient is compliant in the morning and in the evening (i.e. he takes the first and second necessary dosage quantity in accordance with the scheme at 7:30 a.m. and at 6:30 p.m.).
[0095] On day B, the patient is not compliant in the morning. However, he takes the first necessary dosage quantity (retrospectively) at midday (i.e. at 12:30 p.m.). In the evening, the patient is compliant (i.e. he takes the second necessary dosage quantity in accordance with the scheme at 6:30 p.m.).
[0096] On day C, the patient is not compliant in the morning. He also does not take the first necessary dosage quantity (retrospectively) at midday. In the evening however, the patient is compliant (i.e. he takes the second necessary dosage quantity in accordance with the scheme at 6:30 p.m.).
[0097] It should be noted that it is also possible to provide a scheme in which the color level of the respective light signal is increased by one step after half an hour during each application time interval (i.e. when necessary dosage is not applied). For instance, if the patient does not apply the pre-defined necessary dosage quantity until 7:30 a.m. on day A, B or C, the light signal switches from green to yellow. Likewise, if the patient does not apply the pre-defined necessary dosage quantity until 6:30 p.m. on day B, the light signal switches from yellow to red. However, if the patient does not apply the pre-defined necessary dosage quantity at 12:30 p.m. on day B or C (i.e. during the reminder time interval), the light signal does not switch to red but remains yellow. But if the pre-defined necessary dosage quantity is applied at 13:00 p.m. (i.e. at the end of the reminder time interval), the light signal switches to green at 6:00 p.m. (i.e. at the beginning of the second application time interval).
[0098] Further, it is also possible to provide that scheme notices when a pre-defined necessary dosage quantity is applied between the first application time interval and the reminder time interval (then the reminder time interval may be skipped) respectively between the reminder time interval and the second application time interval (then the second application time interval may be skipped).
[0099] Fig. 6 shows an exemplary schematic illustration of a mobile device 30 with an image grid function means (preferably an app) for an interactive determination of a therapy surface on a patient’s skin and of a necessary dosage quantity of a respective skin care product for treating the therapy surface. The image grid function means is adapted for activating on the display 31 of the mobile device 30 one or more grid fields 33 which represent potentially affected skin portions of a patient. In the present example, the grid fields 33 have been numbered from a1 to c5 in a chequered manner for better allocation. The image grid functions means is also adapted for calculating a value for a necessary dosage quantity of the skin care product on the basis of the activated grid field(s). The calculated value for the necessary dosage quantity of the skin care product is transferred to the inventive application compliance device 1 (respectively its control unit), preferably in a wireless manner.
[00100] For instance, if the patient has an eczema in the area of his left underarm and at his breast, the doctor (or the patient) will activate grid fields c3 and b4, e.g. with the finger. The image grid function means will then calculate the necessary dosage quantity of skin care product for treating the affected skin portions (e.g. in a whole number of pump hubs from the respective dispenser device wherein one hub represents a certain quantity of skin care product, as for example 5, 10, 25, 50 or 100 ml etc.). If for example the image grid function means calculates that altogether 15 ml are required - 5 ml for grid field c3 per application and 10 ml for grid field b4 per application with one pump hub representing 5 ml - the inventive application compliance device 1 will monitor whether in each application time 15 ml (i.e. three hubs for the patient) are administered.
[00101] Yet, in another aspect, the mobile device 30 may also be used with its camera 32. In this case, the mobile device 30 is provided with an image recognition function means (preferably also an app) for an interactive determination of a therapy surface on a patient’s skin and of a necessary dosage quantity of a respective skin care product for treating the therapy surface. The image recognition function means is adapted for detecting and measuring one or more affected skin portions of a patient and for calculating a value for a necessary dosage quantity of the skin care product for the affected skin portion(s). The calculated value for the necessary dosage quantity of the skin care product is then transferred to the inventive application compliance device 1 (respectively its control unit), preferably in a wireless manner.
[00102] The image recognition function means may detect by means of the camera 32 of the mobile device 30 and a skin change recognition program or algorithm which kind of pathological skin change exists on the user’s skin and may measure the size respectively surface of the affected skin portion (e.g. using the same or a further improved grid field). From these parameters, the image recognition function means may calculate a necessary dosage quantity for different skin care products used for different skin changes respectively skin diseases. As in the previous embodiment with the image grid function means, the inventive application compliance device 1 will monitor whether the correct dosage quantity is administered at the respective application time.
[00103] In particular, the image recognition function means may detect by means of the camera 32 of the mobile device 30 affected skin portions of a patient onto which (as indicator lotion) a cream with colour pigments has been applied beforehand, as for example indicated by means of the spots 34 in grid fields c3 and a3 of Fig. 6 representing exemplarily the crook of the arms. The patient only has to apply the colour pigmented cream once at the affected skin portions for allowing calibration of the system. The cream is fluorescing and reflecting. The patient or doctor may decide on either a grid field or a contrasting image application to define the affected skin area.
[00104] Advantageously, this App may be included in the App used in connection with the previous embodiment (i.e. with the image grid function mode) and thus form a combined App respectively a system which may be provided on a mobile phone. In other words, when using the (combined) app respectively system, the user can decide whether he wants to apply the image grid function mode or the image recognition mode.
[00105] This description and the accompanying drawings that illustrate aspects and embodiments of the present invention should not be taken as limiting-the claims defining the protected invention. In other words, while the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive. Various mechanical, compositional, structural, electrical, and operational changes may be made without departing from the spirit and scope of this description and the claims. In some instances, well-known circuits, structures and techniques have not been shown in detail in order not to obscure the invention. Thus, it will be understood that changes and modifications may be made by those of ordinary skill within the scope and spirit of the following claims. In particular, the present invention covers further embodiments with any combination of features from different embodiments described above and below.
[00106] The disclosure also covers all further features shown in the figures individually although they may not have been described in the afore or following description. Also, single alternatives of the embodiments described in the figures and the description and single alternatives of features thereof can be disclaimed from the subject matter of the invention or from disclosed subject matter. The disclosure comprises subject matter consisting of the features defined in the claims or the exemplary embodiments as well as subject matter comprising said features.
[00107] Furthermore, in the claims the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. A single unit or step may fulfil the functions of several features recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. The terms “essentially”, “about”, “approximately” and the like in connection with an attribute or a value particularly also define exactly the attribute or exactly the value, respectively. The term “about” in the context of a given numerate value or range refers to a value or range that is, e.g., within 20%, within 10%, within 5%, or within 2% of the given value or range. Components described as coupled or connected may be electrically or mechanically directly coupled, or they may be indirectly coupled via one or more intermediate components. Any reference signs in the claims should not be construed as limiting the scope.
List of reference numbers:
1 application compliance device 7 signal unit/LED unit
2 housing 7a light-emitting diodes
2a housing inner wall 8 control unit 2b housing outer wall 8a connection element
2c housing top opening 9 converter unit (A/D converter)
3 collar element 10 sensor unit (weighing sensor)
3a flange portion 10a weighing plate
3b collar opening 10b mounting element
3c engagement portions/flexible 10c bore for mounting element tongues
10d sensor body
3d outer wall portions
11 electrical interconnections
3e bevel
12 integrated on/off switch
3f inner wall
12a topside
3g apertures
12b guide for switch
4 base plate
20 container/dispenser
4a receiving structure base plate
21 cap
5 cover element (punched-out)
22 body
5a punched out letters
30 mobile device
6 support plate
31 display
6a openings for light-emitting diodes
32 camera
6b opening for switch
33 grid fields
D1 first diameter (top opening housing)
34 creamed portions
D2 second diameter (collar opening)
35 patient wf width flange portion

Claims

Claim 1: Application compliance device (1) for monitoring a customized dosage regime of a skin care product provided in a container device (20), comprising: a housing (2) having an inner wall (2a) and an outer wall (2b), and defining a top opening (2c) configured to receive the container device (20) in the application compliance device (1), a control unit (8), a sensor unit (10) configured to sense a quantity of the skin care product administered from the container device (20), when being received in the application compliance device (1), and a signal unit (7), wherein the sensor unit (10) and the signal unit (7) are coupled to the control unit
(8), the housing (2) houses the control unit (8), the sensor unit (10) and the signal unit (7), and characterized in that the control unit (8) is configured to evaluate a quantity signal received from the sensor unit (10) to determine an administered dosage quantity, to control the signal unit (7) to generate a compliant signal if the administered dosage quantity is compliant with the customized dosage regime, to control the signal unit (7) to generate a partly compliant signal if the administered dosage quantity is not compliant with the dosage regime for a first time, and to control the signal unit (7) to generate a warning signal if the administered dosage quantity is not compliant with the dosage regime for a second time.
Claim 2: Application compliance device (1) according to claim 1, further comprising at least one collar element (3) adapted to be inserted into the top opening (2c) of the housing (2). Claim 3: Application compliance device (1) according to claim 2, wherein the top opening (2c) of the housing (2) has a first diameter (D-i), the at least one collar element (3) defines a collar opening (3b) with a second diameter (D2) adapted to receive the container device (20) and the at least one collar element (3) has one or more engagement portions (3c) which interact with one or more corresponding engagement portions of the inner wall of the housing (2a).
Claim 4: Application compliance device (1 ) according to claim 3, wherein the one or more engagement portions (3c) of the collar element (3) comprise a flexible tongue.
Claim 5: Application compliance device (1 ) according to claim 3 or 4, wherein the second diameter (D2) of the collar opening (3b) is smaller than the first diameter (Di) of the top opening (2c) of the housing (2).
Claim 6: Application compliance device (1 ) according to any one of the preceding claims, wherein the control unit (8) is programmable and comprises one or more computer programs and/or algorithms.
Claim 7: Application compliance device (1 ) according to any one of the preceding claims, wherein the sensor unit (10) comprises a weighing sensor.
Claim 8: Application compliance device (1 ) according to claim 7, wherein the weighing sensor has a sensor body (10d) and a weighing plate (10a) adapted to be mounted to the sensor body (10).
Claim 9: Application compliance device (1) according to claim 8, wherein the weighing plate (10a) comprises a mounting element (10b) adapted for mounting the weighing plate (10a) to the sensor body (10d).
Claim 10: Application compliance device (1 ) according to any one of the preceding claims, comprising a converter unit (9) coupled to the control unit (8) and housed by the housing (2). Claim 11 : Application compliance device (1 ) of claim 10, wherein the converter unit
(9) comprises an A/D converter adapted to amplify an analogue signal and to digitally convert analogue signal.
Claim 12: Application compliance device (1) according to any one of the preceding claims, wherein the signal unit (7) comprises one or more light-emitting diodes (7a).
Claim 13: Application compliance device (1 ) according to any one of the preceding claims, wherein the device further comprises an integrated on/off switch (12), the integrated on/off switch (12) being integrated in the housing (2) and configured to be activated when the container device (20) is inserted into the application compliance device (1).
Claim 14: Application compliance device (1 ) according to any one of the preceding claims, wherein the housing (2) further includes a base plate (4) having a receiving structure (4a) adapted to receive the control unit (8), the sensor unit (10), the converter unit (9), the signal unit (7) and/or the integrated on/off switch (12).
Claim 15: Application compliance device (1 ) according to any one of the preceding claims, further comprising a support plate (6) arranged within the housing (2) and, optionally, having openings (6a, 6b) for the signal unit (7), the mounting element (10b) of the weighing plate (10a) and/or the integrated on/off switch (12).
Claim 16: Application compliance device (1 ) according to any one of the preceding claims, wherein the housing outer wall (2b) comprises a punched-out cover element (5) adapted to receive different labels indicating distinctively the skin care product to be administered.
Claim 17: Application compliance device (1) according to any one of the preceding claims, wherein the customized dosage regime is defined in the control unit by setting a necessary dosage quantity and a time scheme comprising the first time and the second time.
Claim 18: Application compliance device according to claim 17, wherein the control unit is configured to identify if the administered dosage quantity is compliant with the customized dosage regime by comparing the administered dosage quantity to the necessary dosage quantity.
Claim 19: Method of monitoring a customized dosage regime for a skin care product provided in a container device (20), comprising: obtaining an application compliance device (1) according to any one of the preceding claims, positioning the container device (20) in a housing (2) of the application compliance device (1 ) such that the container device is accessible to a senor unit of the application compliance device, the sensor unit of the application compliance device sensing a quantity of the skin care product inside the container device, the control unit (7) of the of the application compliance device (1 ) evaluating a quantity signal received from the sensor unit (10) to determine an administered dosage quantity, generating a compliant signal if the administered dosage quantity is compliant with the customized dosage regime, generating a partly compliant signal if the administered dosage quantity is not compliant with the customized dosage regime for a first time, and generating a warning signal if the administered dosage quantity is not compliant with the customized dosage regime for a second time.
Claim 20: Method of claim 19, comprising a step of defining the customized dosage regime by setting a necessary dosage quantity of the skin care product to be administered and a time scheme comprising the first time and the second time.
Claim 21 : Method for an interactive determination of a therapy surface on a patient’s skin and of a necessary dosage quantity of a respective skin care product for treating the therapy surface, comprising providing a mobile device (30) with an image grid function means, the image grid function means being adapted for activating on the display (31 ) of the mobile device (30) one or more grid fields (33) which represent potentially affected skin portions of a patient (35) and for calculating a value for a necessary dosage quantity of the skin care product on the basis of the activated grid field(s) (33); activating on the display (31 ) of the mobile device (30) one or more grid field(s) (33) representing affected skin portion(s) of the patient; calculating a value for a necessary dosage quantity of the skin care product based on the activated grid field(s) (33);
(d) transferring the calculated value for the necessary dosage quantity of the skin care product to a control unit (8) of, preferably, an inventive application compliance device (1 ).
Claim 22: Method of claim 21 , wherein the mobile device (30) is connected to the application compliance device (1 ) in a wireless manner.
Claim 23: Method of claim 21 or 22, wherein the image grid function means is provided on the mobile device (30) in the form of an App.
Claim 24: Method for an interactive determination of a therapy surface on a patient’s skin and of a necessary dosage quantity of a respective skin care product for treating the therapy surface, comprising providing a mobile device (30) having a camera (32) with an image recognition function means, the image recognition function means being adapted for detecting and measuring one or more affected skin portion(s) of a patient (35) and for calculating a value for a necessary dosage quantity of the skin care product for the affected skin portions; detecting and measuring one or more affected skin portion(s) by using the camera (32) of the mobile device (30); calculating a value for a necessary dosage quantity of the skin care product for the affected skin portion(s); transferring the calculated value for the necessary dosage quantity of the skin care product to a control unit (8) of, preferably, an inventive application compliance device (1 ).
Claim 25: Method of claim 24, wherein the mobile device (30) is connected to the application compliance device (1 ) in a wireless manner.
Claim 26: Method of claim 24 or 25, wherein the image recognition function means is provided on the mobile device (30) in the form of an App. Claim 27: Method of any one of claims 24 to 26, wherein, in an initial step, an indicator substance is applied to an affected skin portion (33) of the patient (35) for calibrating the image recognition function means.
Claim 28: Method of any one of claims 24 to 27, wherein the image recognition function means comprises a skin change recognition program or algorithm.
Claim 29: System for an interactive determination of a therapy surface on a patient’s skin and of a necessary dosage quantity of a respective skin care product for treating the therapy surface, the system being configured to provide a selection function for the user to either apply the method according to any one of claims 21 to 23 or the method according to any one of claims 24 to 28.
Claim 30: System according to claim 29, wherein the image grid function means and the image recognition function means are provided on a mobile device (30) in the form of a combined App.
EP22735143.4A 2021-06-18 2022-06-17 Application compliance device Pending EP4355285A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH7122021 2021-06-18
PCT/EP2022/066537 WO2022263622A2 (en) 2021-06-18 2022-06-17 Application compliance device

Publications (1)

Publication Number Publication Date
EP4355285A2 true EP4355285A2 (en) 2024-04-24

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ID=78371705

Family Applications (1)

Application Number Title Priority Date Filing Date
EP22735143.4A Pending EP4355285A2 (en) 2021-06-18 2022-06-17 Application compliance device

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Country Link
EP (1) EP4355285A2 (en)
WO (1) WO2022263622A2 (en)

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103917272A (en) * 2011-09-15 2014-07-09 西格玛仪器控股有限责任公司 System and method for treating skin and underlying tissues for improved health, function and/or appearance
US10219737B2 (en) * 2014-12-11 2019-03-05 Skin Depth Inc. Topical product dispensing tool
US10441214B2 (en) * 2015-01-29 2019-10-15 Kali Care, Inc. Monitoring adherence to a medication regimen using a sensor
JP7121733B2 (en) * 2016-10-07 2022-08-18 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング Systems and methods for compliance management
EP3560376B1 (en) * 2016-12-20 2021-08-18 Shiseido Company, Ltd. Application control device, application control method, program, and recording medium
EP3863590A4 (en) 2018-10-10 2022-04-13 Sensal Health, LLC Medication adherence apparatus and methods of use
KR102293668B1 (en) * 2019-04-26 2021-08-26 김병석 Skin care system and method

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WO2022263622A3 (en) 2023-02-02

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