Key information

Title
A HYBRID DEVICE AND METHOD FOR INDICATING A FIRST, A SECOND AND A THIRD STATE OF A MEDICINE
Application number
20221118
Case type
National
Status
24.11.2025 Patent meddelt (B1)
Filed
19.10.2022
Effective date
19.10.2022
Publicly available
22.04.2024
Next annual fee due
31.10.2027
Applicant
CMEYE AS (NO)
Owner
CMEYE AS (NO)
Inventor
Firouz Rezvani Dehaghani (NO) et al.
Agent
BRYN AARFLOT AS (NO)
Granted
24.11.2025
Patent number
349280
Expiry date
19.10.2042

Abstract and drawing

Disclaimer: This text has been machine-scanned and may contain errors – please refer to "Publications" for legally binding content.
The invention relates to device and method for indicating one or more conditions of a product comprising: a first indicator configured to be in a first state when the product is maintained in one or more first predetermined conditions; and change state to indicate one or more further conditions of the product; and a timer having a predetermined duration configured to be activated contemporaneously with the change of state of the first indicator; wherein the device is further configured to indicate when the predetermined duration of the timer has elapsed.

Publications

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Documents

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Date
 Date Doc. No. Process Case number In/Out Journal description To/from
 27.11.2025 15-01 Saksbehandling 20221118(349280) UT PT Registreringsbrev nasjonal patent (15) (PT20221118)
28.10.2025 14-01 Saksbehandling 20221118 UT Intention to grant BRYN AARFLOT AS
 22.05.2025 13-07 Saksbehandling 20221118 INN Response NIPO_5th June 2025 BRYN AARFLOT AS
 22.05.2025 13-06 Saksbehandling 20221118 INN 141969 Norwegian claims_BC BRYN AARFLOT AS
 22.05.2025 13-05 Saksbehandling 20221118 INN 141969 Amended Description_5th June 2025_clean BRYN AARFLOT AS
 22.05.2025 13-04 Saksbehandling 20221118 INN 141969 Amended Description_5th July 2025_tracked_141969 BRYN AARFLOT AS
 22.05.2025 13-03 Saksbehandling 20221118 INN 141969 Amended claims 5th June 2025_clean BRYN AARFLOT AS
 22.05.2025 13-02 Saksbehandling 20221118 INN 141969 Amended claims 5th June 2022_tracked_141969 BRYN AARFLOT AS
 22.05.2025 13-01 Saksbehandling 20221118 INN Korrespondanse (Hovedbrev inn) BRYN AARFLOT AS
 05.03.2025 12-01 Saksbehandling 20221118 UT Substantive Examination BRYN AARFLOT AS
 26.02.2025 11-01 Saksbehandling 20221118 UT Generelt brev uten frist ENG BRYN AARFLOT AS
 15.10.2024 10-03 Saksbehandling 20221118 INN Transmitting IPRP Cover Letter BRYN AARFLOT AS
 15.10.2024 10-02 Saksbehandling 20221118 INN IPRP for parrallel international case PCT-NO2023-060067pdf BRYN AARFLOT AS
 15.10.2024 10-01 Saksbehandling 20221118 INN Korrespondanse (Hovedbrev inn) BRYN AARFLOT AS
 04.10.2024 09-04 Saksbehandling 20221118 INN 141969NO Amended claims 4th October 2024_tracked BRYN AARFLOT AS
 04.10.2024 09-03 Saksbehandling 20221118 INN 141969NO Amended claims 4th October 2024_clean BRYN AARFLOT AS
 04.10.2024 09-02 Saksbehandling 20221118 INN 141969 Response NIPO_4th October 2024 BRYN AARFLOT AS
 04.10.2024 09-01 Saksbehandling 20221118 INN Korrespondanse (Hovedbrev inn) BRYN AARFLOT AS
 02.09.2024 08-01 Saksbehandling 20221118 UT PT Varsel om betaling av første årsavgift (3317) (PT20221118) BRYN AARFLOT AS
 04.07.2024 07-01 Saksbehandling 20221118 UT Substantive Examination BRYN AARFLOT AS
 20.11.2023 06-04 Saksbehandling 20221118 INN Response NIPO BRYN AARFLOT AS
 20.11.2023 06-03 Saksbehandling 20221118 INN 141969 amended claims_tracked BRYN AARFLOT AS
 20.11.2023 06-02 Saksbehandling 20221118 INN 141969 amended claims_clean BRYN AARFLOT AS
 20.11.2023 06-01 Saksbehandling 20221118 INN Korrespondanse (Hovedbrev inn) BRYN AARFLOT AS
 19.05.2023 05-02 Saksbehandling 20221118 UT PT report 04:28:39
19.05.2023 05-01 Saksbehandling 20221118 UT 20221118_1713143_PT 08 Eng BRYN AARFLOT AS
 08.11.2022 04-03 Saksbehandling 20221118 INN GPOA - CMeye signed BRYN AARFLOT AS
 08.11.2022 04-02 Saksbehandling 20221118 INN Declaration - signed BRYN AARFLOT AS
 08.11.2022 04-01 Saksbehandling 20221118 INN Korrespondanse (Hovedbrev inn) BRYN AARFLOT AS
 21.10.2022 03-01 Saksbehandling 20221118 UT Formal Examination 1 BRYN AARFLOT AS
 21.10.2022 02-01 Saksbehandling 20221118 UT Informasjon til oppfinner Lars Kilaas
 19.10.2022 01-05 Saksbehandling 20221118 INN Claims_FOR FILING BRYN AARFLOT AS
 19.10.2022 01-04 Saksbehandling 20221118 INN Abstract_FOR FILING BRYN AARFLOT AS
 19.10.2022 01-03 Saksbehandling 20221118 INN 141969 drawings_FOR FILING BRYN AARFLOT AS
 19.10.2022 01-02 Saksbehandling 20221118 INN 141969 Description_FOR FILING BRYN AARFLOT AS
 19.10.2022 01-01 Saksbehandling 20221118 INN Søknadsskjema Patent BRYN AARFLOT AS

Description, claims and drawings

Disclaimer: This text has been machine-scanned and may contain errors – please refer to "Publications" for legally binding content. Description
3492801A HYBRID DEVICE AND METHOD FOR INDICATING A FIRST, A SECONDAND A THIRD STATE OF A MEDICINEBackground5Perishable products may comprise fluid or granular products that may spoil when exposed to an undesirable condition. Such an undesirable condition may be a temperature outside an acceptable range, such as a temperature that is too high or a temperature that is too low. Other undesirable conditions may be: an 10 exposure to ultraviolet light or infrared light; exposure to pressures outside of an acceptable range; bacterial or fungal contamination; and exposure to radioactivity. Perishable products are utilized across a range of industries and may comprise granular materials, such as powders or particles, or fluids, such as liquids, emulsions or colloidal dispersions. Some example perishable products in the 15 medical field are: vaccines, medicines, intravenous fluids and biological samples, such as blood samples or saliva samples, to name a few non-limiting examples.Certain perishable products, in particular pharmaceutical products, are thermolabile and should be stored within a specific temperature range 20 recommended by the manufacturer. Thermolabile products that are exposed to temperatures outside of their specific temperature range may lose their chemical stability, degrade and/or lose their potency. It may also cause impurities to form which can pose deadly hazards. These impurities may not be visually detectable. 25 In some cases, particular transport and storage technology is used to safely transport the perishable product from the production location to the end-user and avoid spoiling. A particular example of said transport and storage technology is a temperature-controlled chain (cold-chain) which is often used for said thermolabile products, such as for vaccines and insulin which are temperature sensitive. In cold 30 chain technology, every environment for which the product is subjected to from the time of production, through packaging, storage and transport until they reach, and/or are administered into, an individual is retained within the product’s specific temperature range. Cold chain logistics ensure the quality and safety of 3492802thermolabile products. To ensure correct cold-chain management, every logistics step should be well documented. This should provide transparency should any potential deviation from the specific temperature range occur, for instance as a result of inadequate packaging, shipment/transport delays, and repeated opening 5 and closing the storage area (for example as a result of multiple deliveries).When a wholesaler delivers thermolabile drugs to a clinical area/pharmacy the drugs are stored according to their temperature sensitivity. The temperature sensitivity is specific to a particular drug variety and dosage and is provided by the 10 drug manufacturer. The clinical areas/pharmacy monitor the temperature of the storage units accordingly. A pharmacy refrigerator is a common piece of equipment found in clinical areas. It is used to ensure specific medicines are safely stored within a narrow temperature range in line with manufacturers' instructions; this is often between 2˚C and 8˚C. Drugs which may be stored in a pharmacy 15 refrigerator include: vaccines; insulin; chemotherapy drugs; and topical preparations, such as some types of eye drops, to name a few non-limiting examples.Some injectable drugs, for example insulin, are meant to be used once or more 20 during the day and may be administered via a medical pen. Many injectable drugs should preferably reach room temperature before being administered into a patient since injecting cold medicine may cause discomfort, pain and/or local tissue irritation. 25 Often when the injectable drug reaches room temperature it should be used during a specific period of time.For a particular injectable drug, a user may need to know if the drug has reached room temperature and, thus, must not be re-refrigerated, and should be used 30 within the time span defined by the manufacturer. The user may collect a quantity of supply of the drug for a particular time period, for example a three-month supply, from a pharmacy. The user may store the three-month supply within their home. Thus, once the drug (medicine) has left the pharmacy the temperature 3492803controlled chain is broken. The temperature of the drug (medicine) is no longer being carefully monitored and controlled. The temperature of the drug may be exposed to non-storage appropriate environments whilst in the possession of the user. For example, whilst in transit from the pharmacy to the user’s home, or whilst 5 stored in the user’s non-medical refrigerator. Whilst stored in the user’s nonmedical refrigerator there could be a power cut to the electricity supply of the refrigerator, the refrigerator door could be inadvertently left open, or there may be inconsistent refrigeration, all of which could lead to temperature variations within the drug storage environment. Home refrigerators are unlikely to have a 10 monitoring system as sophisticated as those in healthcare establishments.Another challenge a user may face with thermolabile drugs is how to know that the drug has reached the end of its shelf life at room temperature and is no longer usable. In an example wherein the drug is insulin, at room temperature insulin will 15 start to degrade and lose its potency after approximately 28 days. Insulin is used to maintain blood sugar levels in a normal range. If the user fails to keep a record of how long the drug has been outside the fridge they may use insulin in an ineffective state which may lead to serious health problems. 20 There are several perishable products, in particular perishable drugs such as insulin, that, in addition to temperature control, also require monitoring of a predefined time interval that the drug can be used after the vials, container or injection pen have been used for the first time. 25 Perishable products may unintentionally be exposed to undesirable conditions. For instance, cooling installations may malfunction, insufficient sterilization may occur, or human errors may arise during handling of the perishable product. As mentioned it is often not apparent from visual observation of the perishable product that spoiling has occurred. Failing to detect spoiling, especially for 30 perishable products in the medical field, such as vaccines or medicines, may have severe or even life-threatening consequences. Therefore, it is essential to monitor and signal whether the perishable product has been exposed to an undesirable 3492804condition during transport, storage or the drug has exceeded a predefined time interval for use.The above-described problems are common problems with temperature sensitive 5 medications. The invention described herein aim to mitigate some of these abovementioned problems with temperature sensitive drugs.EP2990792A1 discloses an elapsed timer device includes a timer element comprising a timer chamber, a timer chamber conditioning material disposed 10 within the timer chamber, and a sensor arranged to sense a timer chemical within the timer chamber. The sensor indicates elapsed time in response to a threshold level of the chemical being present within the timer chamber. The timer chamber, timer chemical adsorption/desorption characteristics of the timer chamber conditioning material, and the sensor are configured so that an amount of the timer 15 chemical within the timer chamber reaches the threshold level within a predetermined time after initialization of the timer element.US2011121023A1 discloses a packaging, locking and indication system for dispensing a material that has a limited period of utility, a device comprises a first 20 part containing the material and a second part, wherein the first and second parts have mutual engagement means and can be disengaged to allow the material to be dispensed, wherein the device includes, located within the device, control means that can be activated to initiate a time-controlled period of use and that, at the end of that period, causes the first and second parts to be permanently 25 engaged.WO03087955A1 relates to a food product freshness indicator, which is convenient specifically for the consumer in order to readily determine whether a given product is still fit for safe consumption after a certain amount of time elapsed from the day 30 first opened and /or unpacked. The said indicator accommodates a programmable controller with a dedicated power supply source and coupled with at least one display element and /or at least one sound-emitting element. There is at least one sensor and timer dedicated to the said indicator, while the said sensor is triggered 3492805off by an external impulse. This invention relates also to a packaging, specifically for food products, equipped with the said indicator.NO321426B1 discloses a recording means forming part of a packaging/seal of a 5 product where said recording means is user-activated and said user-activated means will, upon activation, emit a visible and dynamic indication of the condition of the product(s) where the indication is based on input parameter(s) that affect the effective life of said product and the parameter(s) are recorded by said recording means. Said recording means will provide a visible and audiovisual 10 notification at the "best before" date of said product.Summary of the Invention 15 According to a first aspect of the invention there is provided a hybrid device for indicating a first, a second and a third state of a medicine comprising: a single temperature-activated and manually-activated indicator for indicating one of the first, second and third state only, the indicator having a manual actuator for changing the state of the indicator manually by a user and is configured to change 20 state in response to a thermo-chemical reaction; the indicator configured to: show a first state when the medicine is: maintained in a safe-storage temperature range; and a first use of the medicine has not started; and the medicine has not been exposed to immediately intolerable conditions; and irreversibly change state to show the second state by temperature-activation when the medicine, or a 25 container that the medicine is contained in, is exposed to temperatures outside the safe-storage temperature range; and irreversibly change state to show the second state by manual-activation by a user when a first use has commenced; and a timer configured with a first predetermined duration equal to the expiry time of the medicine after exposure to non-safe-storage temperatures, and a second 30 predetermined duration equal to the shelf life of the medicine after first use;wherein the timer is configured to be irreversibly activated with the first predetermined duration contemporaneously with the temperature-activated change of state of the indicator, and irreversibly activated with the second 3492806predetermined duration contemporaneously with the manual-activated change of state of the indicator; wherein the indicator is further configured to:irreversibly change to show the third state upon elapse of the first predetermined duration or the second predetermined duration of the timer to provide the 5 indication that the first or second predetermined duration has elapsed rendering the medicine unusable; and irreversibly change to show the third state upon exposure of the medicine to immediately intolerable conditions such that the medicine is unusable. 10 The indicator may be a visual indicator.The indicator may be a chemical-based indicator and the timer may be a hybrid chemical-based and an electronic timer. 15 Wherein the medicine is insulin, the predetermined safe-storage temperature range may be 2°C to 8°C; the first predetermined duration, equal to the expiry time of the medicine after exposure to non-safe-storage temperatures, may be in the range of 4 to 6 weeks; the second predetermined duration, equal to the shelf life of the medicine after first use, may be in the range of 4 to 6 weeks; and 20 wherein intolerable conditions may comprise exposure to temperatures below freezing and/or above 30 degrees.The visual indicator may be further configured to be: a first colour when the visual indicator is in the first state; a second colour when the visual indicator is in the 25 second state; and a third colour when the visual indicator is in the third state.The indicator may comprise incremental subindicators which are configured to sequentially change from a first state to a further state upon incremental elapse of the predetermined duration.30According to a second aspect of the invention there is provided an injection button for a medical pen, wherein the device of the first aspect of the invention is incorporated as an integrated part into the injection button. 3492807According to a third aspect of the invention there is provided a medical pen comprising the device of the first aspect, wherein the device is integrated into the 5 medical pen or is attached to the medical pen.According to a fourth aspect of the invention there is provided a medical pen comprising the injection button of the second aspect. 10 According to a fifth aspect of the invention there is provided a method for indicating a first, second and third state of a medicine comprising: indicating a first state when the medicine has been: maintained in a safe-storage temperature range; and a first use of the medicine has not started; andthe medicine has not been exposed to immediately intolerable conditions; 15 indicating a second state: by temperature-activation when the medicine, or a container that the medicine is contained in, is subjected to a temperature outside of the predetermined safe-storage temperature range; and by manual-activation by a user when a first use has commenced; and the medicine has been exposed to temperatures outside the predetermined temperature range; and 20 irreversibly indicating a third state when the medicine has been exposed to nontolerable conditions which renders the medicine unsafe for use; activating a timer with a first predetermined duration contemporaneously upon the medicine, or a container that the medicine is contained in, being subjected to a temperature outside of the predetermined safe-storage temperature range and activating a 25 timer with a second predetermined duration contemporaneously upon manualactivation by a user when a first use has commenced; and indicating a third state when: the medicine has been exposed to immediately intolerable conditions such that the medicine is unusable; the first predetermined duration of the timer has elapsed; or the second predetermined duration of the timer has elapsed.30Indicating the first state, indicating the second state, and indicating the third state may comprise visual indication. 3492808The method may further comprises providing an indicator in a first colour to indicate that the medicine is in the first state; changing the indicator from the first colour to a second colour to indicate that the medicine is in a second state; changing the indicator from the second colour to a third colour, or providing a 5 second indicator, to indicate that the medicine is in the third state.The method may further comprise indicating elapse of incremental periods of the predetermined duration.10Brief Description of the DrawingsFig. 1 is a flow diagram of a method for indicating one or more conditions of a product; 15 Fig. 2 is a flowchart of a method of operation of a device concerning exposure of a product to certain temperatures;Fig. 3 is a flowchart of a method of operation of a device concerning a first use of the product;Fig. 4 is a flowchart of a method of operation of a particular example hybrid device 20 according to the invention;Fig. 5a shows a first example of how a device according to the invention can be implemented on, or integrated with, a medical pen;Fig. 5b shows a second example of how a device according to the invention can be implemented on, or integrated with, a medical pen; 25 Fig. 5c shows a third example of how a device according to the invention can be implemented on, or integrated with, a medical pen;Fig. 5d shows a fourth example of how a device according to the invention can be implemented on, or integrated with, a medical pen;Fig. 5e shows a fifth example of how a device according to the invention can be 30 implemented on, or integrated with, a medical pen;Fig. 6a shows a first example progressive indicator;Fig. 6b shows a second example progressive indicator;Fig. 6c shows a third example progressive indicator; and 3492809Fig. 6d shows a fourth example progressive indicator.Detailed Description5The invention describes a device that is suitable for pen-administrated drugs that are temperature sensitive, restricted for use over a predetermined time interval or a combination thereof. The device is preferably visual-based and provides multistep monitoring.10The invention will now be described with reference to the drawings. All the features described in any of the drawings, and throughout the description generally are combinable except where clearly incompatible. 15 Figure 1 is a flow diagram of a method 100 for indicating one or more conditions of a product.The method starts at 10, wherein it is indicated that a product has been maintained in first predetermined conditions. These first predetermined conditions 20 may be a predetermined temperature range. For example, many products need to be kept below room temperature i.e., during storage and/or transport. To achieve this the products may be stored in a refrigerator. Many products need to be maintained within the specific temperature range from manufacture through to use and, thus, require handling with cold-chain technology wherein an uninterrupted 25 series of refrigerated production, storage and distribution activities, along with associated equipment and logistics, maintain quality via a desired low-temperature range. Many medical products need to be stored in the temperature range of two to eight degrees Celsius. Insulin is an example of one of these medical products which needs to be within this temperature range before use. The table below 30 shows a number of example medical products and their associated storage temperature ranges. 34928010Drug/Product Use Storage temperature range (˚C) Abasaglar® Insulin long lasting 2 - 8Ajovy® injection pen Prophylactic against 2 - 8MigrenAranesp® injection pen Against anaemia 2 - 8Avonex injection pen MS 2 - 8Bemfola® In vitro fertilisation 2 - 8Benepali® Immunosuppressive 2 - 8Besremi® injection pen Immune stimulant 2 - 8Bydureon® dep injection Antidiabetic drug 2 - 8subsByetta® injection pen Antidiabetic drug 2 - 8Cimzia® injection pen Immunosuppressive 2 - 8Dupixent® injection pen Immunosuppressive 2 - 8Enbrel® pen Immunosuppressive 2 - 8Fiasp FlexTouch® Insulin fast acting 2 - 8injectionForsteo® injection pen Osteoporosis 2 - 8Genotropin GenPen® Growth hormone 2 - 8GONAL-f® pen In vitro fertilisation 2 - 8Humalog Kwikpen® Insulin fast acting 2 - 8Humira® injection pen Immunosuppressive 2 - 8Hyrimoz® Immunosuppressive 2 - 8Terrosa® injection pen Parathyroid hormone 2 - 8Another example first predetermined condition may be that a first use of the product has not taken place. 5 At 20, it is indicated when the first predetermined conditions have changed. For example, when the product is exposed to a temperature outside of the predetermined (safe storage) temperature range or when a first use of the product has occurred. 10 At 30, a timer is activated contemporaneously with the change of the first predetermined conditions. The timer has a predetermined duration which is dependent on the time of expiry of the product as a result of the change in the first predetermined conditions. The predetermined duration is product specific and often specified by the product manufacturer. For example, once a product has 15 been exposed to a temperature outside a predetermined associated storage temperature, it may have a predetermined number of days until the product spoils 34928011and becomes unusable. In the particular case of insulin, once exposed to temperatures outside of the storage temperature range of 2 to 8˚C, it becomes unusable after around 4 to 6 weeks. The timer may also be activated in response to a first use having occurred.5The table below shows a number of example medical products and their associated durations until expiry after a change in the predetermined conditions.Drug/Product Use DurationAbasaglar® Insulin long lasting 28 days (if kept below 30˚C) Ajovy® injection pen Prophylactic against 7 days (if kept below 30˚C) MigrenAranesp® injection Against anaemia <7 days (if kept below 25˚C) penAvonex® injection MS 7 days (if kept between 15 and pen 30˚C)Bemfola® In vitro fertilisation 90 days (if kept below 25˚C) Benepali® Immunosuppressive <4 weeks (if kept below 25˚C) Besremi® injection Immune stimulant <30 day (if kept between 2 and pen ˚C, use twice)Bydureon® dep Antidiabetic drug 28 days (if kept below 30˚C) injection subsByetta® injection pen Antidiabetic drug 28 days (if kept below 25˚C) Cimzia® injection Immunosuppressive 10 days (if kept below 25˚C) penDupixent® injection Immunosuppressive 14 days (if kept below 25˚C) penEnbrel® pen Immunosuppressive 28 days (if kept below 25˚C) Fiasp FlexTouch® Insulin fast acting 28 days (if kept below 30˚C) injectionForsteo® injection Osteoporosis <28 day (if kept between 2 and pen ˚C)Genotropin Growth hormone <28 day (if kept between 2 and GenPen® ˚C, after reconstitution) GONAL-f® pen In vitro fertilisation <90 day (if kept below 25˚C, before opening)<28 day (if kept below 25˚C, after opening)Humalog Kwikpen® Insulin fast acting 28 days (if kept below 30˚C) Humira® injection Immunosuppressive <14 days (if kept below 25˚C) penHyrimoz® Immunosuppressive <21 days (if kept below 25˚C) Terrosa® injection Parathyroid hormone <28 day (if kept between 2 and pen 8˚C) 34928012At 40, it is indicated when the predetermined duration has elapsed and the product becomes unusable. 5 The method may also indicate that the product is unusable 40 at any stage in the case of an adverse event 13 wherein the product is exposed to non-tolerable conditions which render the product immediately unusable.Mentioned herein is a device for product durability with respect to storage 10 temperatures.A device can indicate a durability of an associated product with respect to predetermined storage temperatures. The device has a first temperature dependent indicator. The first temperature dependent indicator may be a chemical 15 indicator. Alternatively, the first temperature dependent indicator may be an electronic indicator comprising at least one LED. The electronic indicator may have a single LED or an array of LEDs of different colours. In a further alternative arrangement the indicator is a combined chemical/electronic indicator. The device also comprises a timer configured with a predetermined duration substantially 20 equal to the shelf life of the product outside storage temperature conditions. The first indicator may also provide the timer.The device for durability with respect to storage temperatures is configured to perform the method of operation 200 of figure 2.25With reference to figure 2, wherein the product has been maintained in stable storage conditions 205, the device shows a first indication 210. This first indication is provided by the first temperature dependent indicator in a first state. The first state of the first indicator may be a particular colour, such as the colour green. 30 Wherein the first indicator is a chemical indicator, the colour changes upon a thermochemical reaction when exposed to different temperatures. In a particular example wherein the product is to be kept within the temperature range of between 2 and 8˚C, the thermochemical indicator may be configured to be the 34928013colour green when inside this temperature range. Wherein the first indicator is an electronic indicator comprising an LED, the LED is in a first state in the safe storage temperature range. For example, the LED is off (not illuminated). Wherein the first indicator is an electronic indicator comprising an array of coloured LEDs, a 5 first LED (for example a green LED) in the array may be on when the product is within the safe storage temperature range.At 215, the product is exposed to temperatures outside of the safe storage temperature range. In response, the device shows a change from the first 10 indication to a second indication 220. Preferably this change is irreversible. This second indication may be provided by the first temperature dependent indicator in a second state. The second state of the first indicator may be a further particular colour, such as the colour yellow. Wherein the first indicator is a chemical indicator, the first indicator changes colour (by a thermochemical reaction). In the 15 particular example wherein the product’s storage temperature is between 2 and 8˚C, the thermochemical indicator may be configured to change colour, such as to the colour yellow, when exposed to a temperature above 8˚C. Wherein the first indicator is an electronic indicator comprising a single LED, the LED may be configured to change state upon exposure to a temperature exceeding the safe 20 storage temperature, such as changing the colour, intensity, opacity, or frequencies of off/on illuminations. Wherein the first indicator is an electronic indicator comprising an array of coloured LEDs, the first (e.g., green) LED may be configured to turn off, and a second LED (e.g. yellow) may be configured to be turned on, upon exposure to a temperature exceeding the safe storage 25 temperature.After exposure to temperatures outside the first predetermined range 215, the product starts to degrade 225. In response, the device is further configured to start the timer for a predetermined time limit 230. Preferably, starting of the timer is 30 irreversible. The predetermined time limit is equal to a lifetime of the product after exposure to non-storage temperatures. This predetermined time limit may be in the order of months, weeks, days, hours, minutes or seconds depending on the 34928014particular situation/product/condition. This may be demonstrated to the user by the device in two different ways 240a, 240b.At 240a, the device indicates that the timer has commenced by continuing to show 5 the second indication. For example, the first indicator stays the colour yellow (chemical indicator/electronic indicator with LED colour array) or the LED continues to show the same second state intensity, opacity, or frequencies of off/on illumination (electronic indicator). Alternatively, a second indicator may be used to indicate the timer has commenced.10At 240b, the device indicates that the timer has commenced and additionally shows the amount of remaining time/amount of time already expired. This may be achieved by a time-dependent increasing/decreasing opacity, intensity, or activated portions of the first indicator or the separate second indicator.15At 245, the predetermined duration expires. In response, the device shows a third indication indicating that the product is unusable 250. Preferably, showing of the third indication is irreversible. The third indication may be provided by a further change of state of the first indicator. For example, the first indicator may change 20 from the colour yellow to the colour red (chemical indicator/electronic indicator with LED colour array). Alternatively, the second indicator may change state, for example colour, intensity, or opacity (electronic indicator). Yet further a third indicator may change state, for example by being activated, illuminated. 25 The device may be further configured show the third indication 250 indicating that the product is unusable immediately after exposure to intolerable conditions 213, thus bypassing all other steps in the method of operation. The triggering of the third indication 250 in response to intolerable conditions 13 may occur at any stage in the method of operation.30When the device shows the third indication 250, the user should discard the product. 34928015Mentioned herein is a device for durability after first use.A device can indicate a durability of an associated product after a first use. The device has a first manually activated indicator. Thus, the device also has a manual 5 actuator for manually activating the first indicator. The manual actuator may be a push button, pull button, or a pull-out insulation follie. The first manually activated indicator may be a chemical indicator. Alternatively, the first manually activated indicator may be an electronic indicator comprising at least one LED. The electronic indicator may have a single LED or an array of LEDs of different 10 colours. In a further alternative arrangement the indicator is a combined chemical/electronic indicator. The device also comprises a timer configured with a predetermined duration substantially equal to the shelf life of the product after first use. The first indicator may also provide the timer. 15 This device is particularly useful for products that have a specific time duration after first use after which the product expires and becomes unsafe to use. In an example wherein the product is the medical product insulin, after a first use of an insulin pen, it has a lifetime (predetermined usable duration) of around 4 to 6 weeks.20The device for durability after first use is configured to perform the method of operation 300 of figure 3.With reference to figure 3, at 305, a first use has not yet taken place. As a result, 25 the device shows a first indication 310. This first indication may be provided via the first indicator having a first colour, for example green. Alternatively, and in particular when the first indicator is an electronic indicator, the first indication may be provided by an LED in a first state, such as off. 30 Upon manual activation by a user after a first use of the product 315, the device shows a second indication 320 to indicate that said first use has occurred and that the product is in the process of degrading 325. Preferably, once the first indication has changed to the second indication, the second indication cannot be reversed 34928016back into the first indication. The second indication may be provided by a change of state of the first indicator. For example, the first indicator may change from green to yellow (chemical indicator/electronic indicator with LED colour array). In the particular example wherein the first indicator is a single LED electronic 5 indicator, the LED may change state, for example be turned on or start flashing.After manual activation by the user to indicate first use 315, the device is also configured to start the timer 330 for a predetermined time limit equal to the lifetime of the product after first use. Preferably, once the timer has started, the timer 10 continues to run until expiry of the time limit and cannot be reversed. This predetermined time limit may be in the order of months, weeks, days, hours, minutes or seconds depending on the particular situation/product. Similarly to the method of operation described in figure 2, this may be demonstrated to the user by the device in two different ways 340a, 340b.15At 340a, the device continues to show the second indication that first use has occurred until expiry of the time limit 345. At 340b, the device shows incremental elapse of the time limit up to expiry of the time limit 345. In both cases, the device demonstrates to the user that the product has entered a new phase wherein the 20 product will soon expire after a predetermined time or after elapse of its designed shelf-life.At 350, the device shows a third indication that the product is unusable. This third indication may be shown via the first indicator in a third state. Preferably, once the 25 second indication has changed to the third indication, the third indication cannot be reversed back into the second indication. The third state may be a further colour, such as red (chemical indicator/electronic indicator with LED colour array) or a further state of the single LED, such as continually on (a single LED electronic indicator). The third indication is shown by the device upon expiry of the 30 predetermined time limit or product shelf life.The device may be further configured to show the third indication 350, indicating that the product is unusable, immediately after exposure to intolerable conditions 34928017313, thus bypassing all other steps in the method of operation. The triggering of the third indication 350 in response to intolerable conditions 313 may occur at any stage in the method of operation. 5 When the device shows the third indication 350, the user should discard the product.According to the invention, there is provided a hybrid device for durability with respect to storage temperatures and after first use.10A device according to the invention is a combined device for both indicating a durability of an associated product with respect to storage temperatures and after a first use. 15 The device has a first hybrid indicator which is both temperature-activated and manually-activated. Thus, the device also has a manual actuator for manually activating the first indicator. The manual actuator may be a push button, pull button, or a pull-out insulation follie. The first hybrid indicator may be a chemical indicator. Alternatively, the first hybrid indicator may be an electronic indicator 20 comprising at least one LED. The electronic indicator may have a single LED or an array of LEDs of different colours. In a further alternative arrangement the hybrid indicator is a combined chemical/electronic indicator. The device also comprises a hybrid timer configured with a first predetermined duration substantially equal to the expiry time of the product after exposure to non-storage temperatures, and a 25 second predetermined duration substantially equal to the shelf life of the product after first use. The first hybrid indicator may also provide the timer.Figure 4 is a flowchart of a method of operation 400 of a hybrid device wherein the indicator(s) and timer are triggered by either exposure of the product to unstable 30 storage conditions or by manual activation by a user upon first use of the product.With reference to figure 4, at 405, the product has not been exposed to nonstorage conditions, neither has a first use taken place. As a result, the device 34928018shows a first indication 410. This first indication is provided via the first hybrid indicator. The first hybrid indicator may show a first colour, for example green. Alternatively, and in particular when the first indicator is an electronic indicator the first indication may be provided by an LED in a first state, such as off.5If the product is exposed to non-storage temperatures before a first use has occurred 415a, the device is configured to proceed with steps 210 to 240 of the method of operation 200 described above. The timer then has a predetermined duration equal to the time of degradation of the product after exposure to non- 10 storage temperatures. Once this duration has expired 425, the device is configured to indicate to the user that the product is unusable 450 and should be discarded irrespective of the fact that a first use may or may not have occurred.If the product undergoes first use before exposure to non-storage temperatures 15 415b, the device is configured to proceed with steps 310 to 340 of the method of operation 300 described above. The timer then has a predetermined duration equal to the time of degradation of the product after first use. Once this duration has expired 425, the device is configured to indicate to the user that the product is unusable 450 and should be discarded, irrespective of whether or not the device 20 has been exposed to non-storage temperatures.At any stage, if the product is exposed to non-tolerable conditions 413, the device is configured to immediately show the third indication 450 that the product is unusable. This can happen at any stage in the method of operation 400 of the 25 hybrid device.Once the device indicates the third indication, the user should discard the product. Preferably, showing of the third indication is irreversible. 30 The device according to the invention is configured to be incorporated into a medical apparatus, such as a medical pen. The device and its incorporation into a medical apparatus are configured such that when using the medical apparatus, the indicator state changes may be observed without the need for any additional 34928019external device such as a personal computer, smart phone, or any other electronic device. The state changes are easily visible to the user by eye. The indicator can be placed anywhere along a body of the medical apparatus but visible to the user before or during the application of the medical apparatus. Alternatively, the 5 indicator could be placed at the top or around the top push bottom (injection button) of the medical apparatus but visible to the user before or during the application of the medical apparatus. The device according to the invention may be designed and manufactured in a complementary form, shape, and size as the existing medical apparatus. It may be produced separately before it is assembled 10 into the existing assembling process for producing the medical apparatus. In order to avoid interference with the existing assembling process and equipment for the production of the medical apparatus, the device containing the indicator could be manufactured in a separate process or at a separate stage. 15 Figures 5a to 5e show examples of how the device according to the invention can be implemented on, or integrated with, a medical pen. Each of the medical pens in figures 5a to 5e have a pen body 10, a product reservoir 6 for containing a medical product 8, a dosage dial 13, and an injection button 14. The medical pens also have a needle attachment means (not shown) for attachment of a disposable 20 needle 12.The medical pens for use in combination with the device according to the invention may be disposable pens, wherein the product reservoir (cartridge) is integrated into the medical pen body. The medical pens for use in combination with the 25 device according to the invention may also be reusable pens, wherein replaceable cartridges can be attached to the pen body 10.In the example of figure 5a, the device is attached longitudinally to the body 10 of the medical pen. The device could be fixed to an outer surface of the body 10 or 30 be an integrated part of the pen body 10. 34928020In the example of figure 5b, the device is attached at least partially circumferentially to the body 10 of the medical pen. The device could be fixed to an outer surface of the body 10 or be an integrated part of the pen body 10. 5 In the example of figure 5c, the device is attached to the product retainer (cartridge) 6 of the medical pen. The device could be fixed to an outer surface of the cartridge 6 or be an integrated part of the cartridge 6.In the example of figures 5d and 5e, the device is attached to or integrated with 10 the injection button 14 of the medical pen. In the example of figure 5d the device is arranged at least partially circumferentially around the injection button 14. In figure 5e, the device is arranged on an end face of the of the injection button 14.Figure 5e further shows an end on view of two example devices arranged on the 15 end face of the injection button. A first example 1A has a circular shape concentrically within the end face of the injection button 14. A second example 1B is oblong and extends around the edges of the injection button 14. A benefit of the arrangement wherein the device is attached onto or integrated with the injection button is that the device can be easily attached and replaced onto a medical pen 20 by easy attachment of the injection button wherein the injection button is not an integrated part of the medical pen. In this way, the device can be easily retrofit to standard medical pens.In the arrangement of figure 5d or 5e, the indicator can be incorporated as an 25 integrated part into the injection button of the injection pen. The injection button containing the indicator may be designed and manufactured in a complementary form, shape, and size as the existing medical apparatus. It may be produced separately before it is assembled into the existing assembling process for producing the medical apparatus. In order to avoid interference with the existing 30 assembling process and equipment for the production of the medical apparatus the push bottom (injection button) containing the indicator could be manufactured in a separate process or at a separate stage. 34928021Figures 6a to 6d show example progressive indicators such as those suitable for implementing the method of operation steps 240b, and 340b of method of operations 200 and 300, respectively. 5 Figure 6a shows progressive indicator 610 in the form of an elongated bar having 6 progressively activated substates 610a-610f. The first substate 610a of the progressive indicator 610 demonstrates that the product has experienced non predetermined conditions, and a timer has started. In the second substate 610b the progressive indicator 610 demonstrates that one quarter of the total expiry time 10 has elapsed. This is indicated by changing state of one quarter of the first indicator. Wherein the first indicator is a chemical indicator, one quarter may be configured to change colour (e.g. to red) after a quarter of the total expiry time has elapsed. Wherein the first indicator is an electronic indicator one quarter of the first indicator is configured to be unilluminated. The third substates 610c indicates half 15 the total expiry time has elapsed (thus half the first indicator changes colour/is unilluminated), the fourth substate 610d three quarters (three quarters of the first indicator changes colour/is unilluminated) and the fifth substate 610e all of the total expiry time has elapsed (all of the first indicator changes colour/is unilluminated). The substate 610f is an end state indicating that the product is no 20 longer safe to use.Figure 6b shows progressive indicator 620 in the form of a bar having 6 progressively activated substates 620a-620f. Intermediate substates 620b, 620c, 620d and 620e are essentially the reverse of corresponding substates 610b, 610c, 25 610d, and 610e of example progressive indicator 610, i.e., in progressive indicator 620, after each quarterly expiry of the total time, a quarter of the first indicator is activated/illuminated.Figure 6c shows progressive indicator 630 in the form of a circle having 6 30 progressively activated substates 630a-630f. The first substate 630a of the progressive indicator 630 demonstrates that the product has experienced non predetermined conditions, and a timer has started. Each intermediate substate 630b, 630c, 630d, and 630e represent a passing of a quarter of the total expiry 34928022time and is visualised by a changing state of a quarter of the circle area. Similarly to the progressive indicator 610, wherein the first indicator is a chemical indicator, the increments of the total circle area may be configured to sequentially change colour (e.g. to red). Alternatively, wherein the first indicator is an electronic 5 indicator, the increments of the total circle area may be configured to sequentially be unilluminated. The substate 630f is an end state indicating that the product is no longer safe to use.Figure 6d shows a further example progressive indicator 640 also in the form of a 10 circle and also having 6 progressively activated substates 640a-640f. Intermediate substates 640b, 640c, 640d and 640e are essentially the reverse of corresponding substates 630b, 630c, 630d, and 630e of example progressive indicator 630, i.e., in progressive indicator 640, after each quarterly expiry of the total time, a quarter of the circle area is activated/illuminated.15In the example progressive indicators of 610 to 640, the time increments are quarterly. However, this is exemplary only and the time increments may be other divisions of the total expiry time, for example, as little as half the total expiry time up to one thirtieth of the total expiry time.20The invention is not restricted to only use of chemical-based indicators, only electronic-based indicators or solutions, but a combination thereof may also be used to monitor both temperature restrictions and restrictions of time intervals where the product can safely be used.25Chemical/polymer-based solutionsThe indicator may be designed and manufactured to be fully chemical/polymer based with a chemical/polymer solution where colour changes results from one or 30 more of: chemical reactions to undesired temperature, reaction time (timer) and manual activation. 34928023To monitor or visualize that an item (pen) has been exposed to an undesired temperature, the irreversible chemical-based indicator may be produced according to, but not limited to, examples 1 to 3 below. In these embodiments, the chemicals react with each other when the solvent melts at a predefined temperature, to 5 govern the chemical reaction.In the particular example of an injection pen containing insulin, the pen should not be exposed to a temperature below freezing. Pre-frozen solutions of insulin should never be injected and must be discarded. To monitor such a situation, an indicator 10 connected at any visual place to an injector pen, can be manufactured according to, but not limited to, examples 1 and 3 below.In the particular example wherein the product is a drug with other restrictions regarding temperatures, for example, the drug should not be exposed to 15 temperature below approximately -14 °C, a chemical-based indicator as described in example 2 is suitable.Example preparations of chemical-based indicators 20 The following examples 1 to 3 are non-limiting examples of a method of manufacture of chemical-based indicators that irreversibly change colour when exposed to given temperatures.Example 1: Preparation of indicator means for colour change at 0°C using 25 acid/base systems.Reagent 1: NaOH (0.1 M) and Reagent 2: Citric acid (0.033 M) Phenolphthalein, was chilled to 0 °C.1 ml of Reagent 1 was introduced into the vial. The vial was chilled to -80 °C, and the solution allowed to harden, for 30 minutes. One to two 30 layers of 1 ml of water was frozen on top of Reagent 1 in the same way. Finally, Reagent 2 was introduced and frozen. The resulting indicators were then stored at either -20 or -80 ° C until needed. On heating, the indicator turned red in a 34928024temperature interval -0,5°C - 0°C. Re-freezing of indicator showed no colour change.Example 2: Preparation of indicator means for colour change at -15°C using 5 acid/base systems.Reagent 1: NaOH (0.1 M) and Reagent 2: Citric acid (0.033 M) Phenolphthalein, were chilled to 0 °C, and 1 ml of reagent 1 was introduced into the vial. The vial was chilled to -80 °C, and the solution allowed to harden for 30 minutes. One to 10 two layers of a solution DI water:ethanol = 40:60 (each layer 1 ml) were frozen on top of reagent 1 in the same way. Finally, reagent 2 was introduced and frozen. The indicators were then stored at either -20 or -80 °C until needed. On heating, the indicator turned red in a temperature interval -15°C to -14°C. Re-freezing of indicator showed no colour change.15Example 3: Preparation of indicator means for colour change at interval 2 to 4°C using Schiff reagent systems.Reagent 1: Schiff reagent and Reagent 2: Glutaraldehyde aqueous solution (50 % 20 vol.), were chilled to 0 °C, and 1 ml of reagent 1 was introduced into the vial. The vial was chilled to -80 °C, and the solution allowed to harden for 30 minutes. 1 to 2 layers of DI water (each 1 ml) were frozen on top of reagent 1 in the same way. Finally, reagent 2 was introduced and frozen. The indicators were then stored at either -20 or -80 ° C until needed. On heating, the indicator turned purple at a 25 temperature interval 2°C to 4°C. Re-freezing of the indicator showed no colour change.Chemical-based timer indicators 30 Regarding chemical-based indicators that provide the timer of the device, an injector pen may be activated for the first time when the actuator (piston) is pressed. In some examples, the piston breaks a barrier material that keeps the chemicals apart. Thus, the chemicals are mixed, and a chemical reaction starts. 34928025Example chemical-based methods for manufacturing an indicator that acts as a clock/timer in cases where a restricted time of use applies are described below. 5 In a first example, the reaction time to induce an irreversible colour change, may be manipulated by temperature and the concentration of reagents, the degree of solubility of reagents (free in solution, reagents in a suspension), solid reagents and the chemical properties of reagents with respect to chemical functional reactive groups within the molecules. Examples of chemical functional groups 10 constituting reagents may be amines, aldehydes, ketones, carboxylic acids, isocyanates, thiols, to name a few non-limiting examples.In a second example, degradable polymers are used, wherein the degradation of a polymer starts when the piston is pressed the first time. A fluid will then be mixed 15 with the polymer and the fluid will slowly degrade the polymer over a given predefined time. The concentration of degradation products will irreversibly react with each other and generate an irreversible change in opacity or colour after a predefined time. Non-limiting examples of such polymers that may be used include: polyanhydrides, polyesters, poly(3-hydroxybutyrate-co-3-hydroxyvalerate), 20 Dextron, polylactic acid, polyamides, polyurethanes and polyurea poly(amideenamine)s. Degradation time needed to induce a final opacity or colour after a given time interval, may therefore be tailored by type of polymer, type of degradation products and temperature. 25 In a third example, initiators for radical polymerization of monomers/co-monomers are suitable. The type of initiator and monomer system will influence the speed and time for completion of the reaction leading to an irreversible change in opacity or colour. By varying the concentration and type of respective initiator and monomer composition, a gradual change in opacity or colour may be induced and 30 after a predefined time interval, the reaction is completed to induce a permanent opacity or colour.Electronic-based solutions 34928026The indicator may be designed and manufactured to be fully electronic-based for example with the application of light diodes, crystals, liquid crystals or similar. In this case opacity or colour changes are controlled by electronic solutions to detect 5 and highlight situations as items/pens are exposed to undesired temperature, on/off of light signals, timers/clocks, and manual activation.There exists a number of commercial electronic circuits that act as a thermometer and/or a timer/clock unit. These units may be coupled to light emitting diodes to 10 irreversibly emit a desired opacity or colour. A first circuit may control signals for emitting a specific light if said first circuit is exposed to a given temperature or a temperature range. The first circuit, or a second circuit, may also be activated, for example by pressing the piston of an injection pen to start a clock/timer function. The timer function starts when the piston is pressed for the first time and, after 15 reaching a predefined time (time interval), the electronic circuit irreversibly activates a power signal to the diode and a specific light will be emitted. Based on the colour being emitted, the end-user can clearly see if the injection pen is safe to use. 20 Hybrid or combined chemical/polymer based and electronic based solutions:The indicator may be designed and manufactured to be a combination of chemical/polymer-based solutions combined with electronic based solutions for example with the application of: electronic devices, switches, light diodes, crystals, 25 liquid crystals or similar.In a particular example, colour changes in response to exceeding a given temperature or a temperature range may be controlled and indicated by use of a chemical reaction, whereas a specific time interval (clock/timer) may be controlled 30 and verified by use of an electronic circuit. Alternatively, colour changes in response to exceeding a given temperature or a temperature range may be controlled and indicated by use of an electronic circuit, whereas a specific time interval (clock/timer) may be controlled and verified by a chemical reaction. 34928027In another example, a temperature range may be controlled by an electronic circuit to emit or induce a given irreversible change in opacity or colour after activation. The timer (time interval) may be activated by pressing a piston a first time. The 5 clock is started and when reaching a predefined time, an electronic circuit provides power to a unit containing liquid crystals. The type of liquid crystals can be tailored to give a defined opacity or colour.Chemical-based and electronic-based solutions will be case specific and 10 dependent on the specific product, application area, medical apparatus device or other desired properties of an application. The best combination of solutions may be chosen accordingly.The invention seeks to give the user of products, in particular medicinal drugs, an 15 easy way to monitor the status of the drug with respect to both temperature stability and how long it is safe to administer the drug after first time use. The device and method are based on visual detection of indicators that clearly show the different statuses of the product. As described above, the visual status is achieved by a change in opacity, colour or a combination thereof. As long as the 20 temperature indicator stays in a first state, for example the colour green, the user knows that the product has not been exposed to temperatures outside a given temperature range, and is safe to use. However, if the indicator has changed to a second state, for example the colour red, the product should not be used, and discarded according to guidelines. Likewise, if the time interval indicator changes 25 state, for example turns yellow after first time use of an associated administrator pen, the product is safe to use. The injection pen is hence safe to use for new injections as long as the time dependent stability interval has not been exceeded. When the time interval indicator changes state, for example to the colour red, the user easily will be aware of this. The injection pen is unsafe to use and should be 30 discarded.Having described preferred examples of the invention it will be apparent to those skilled in the art that other embodiments incorporating the invention may be used. 34928028These and other examples of the invention illustrated above are intended by way of example only and the actual scope of the invention is to be determined from the appended claims.
Claims
34928029P A T E N T C L A I M S1. A hybrid device (1A, 1B) for indicating a first, a second and a third state of a5 medicine comprising:a single temperature-activated and manually-activated indicator (610, 620, 630, 640) for indicating one of the first, second and third state only, the indicator having a manual actuator for changing the state of the indicator manually by a user and is configured to change state in response to a thermo-chemical reaction;10 the indicator configured to:show a first state when the medicine is:maintained in a safe-storage temperature range; and a first use of the medicine has not started; andthe medicine has not been exposed to immediately intolerable15 conditions; andirreversibly change state to show the second state by temperature-activation when the medicine, or a container that the medicine is contained in, is exposed to temperatures outside the safe-storage temperature range; and20 irreversibly change state to show the second state by manualactivation by a user when a first use has commenced; anda timer configured with a first predetermined duration equal to the expiry time of the medicine after exposure to non-safe-storage temperatures, and a second predetermined duration equal to the shelf life of the medicine after first25 use;wherein the timer is configured to be irreversibly activated with the first predetermined duration contemporaneously with the temperature-activated change of state of the indicator, and irreversibly activated with the second predetermined duration contemporaneously with the manual-activated change of30 state of the indicator;wherein the indicator is further configured to:irreversibly change to show the third state upon elapse of the first predetermined duration or the second predetermined duration of the timer34928030to provide the indication that the first or second predetermined duration has elapsed rendering the medicine unusable; andirreversibly change to show the third state upon exposure of the medicine to immediately intolerable conditions such that the medicine is5 unusable.2. The device of claim 1, wherein the indicator is a visual indicator.3. The device of claim 1 or 2, wherein the indicator is a chemical-based10 indicator and the timer is a hybrid chemical-based and an electronic timer.4. The device of any of claims 1 to 3, wherein the medicine is insulin and wherein:the predetermined safe-storage temperature range is 2C to 8C;15 the first predetermined duration, equal to the expiry time of the medicine after exposure to non-safe-storage temperatures, is in the range of 4 to 6 weeks;the second predetermined duration, equal to the shelf life of the medicine after first use, is in the range of 4 to 6 weeks; andwherein intolerable conditions comprise exposure to temperatures below20 freezing and/or above 30 degrees.5. The device of any of claims 2 to 4, wherein the visual indicator is further configured to be:a first colour when the visual indicator is in the first state;25 a second colour when the visual indicator is in the second state; anda third colour when the visual indicator is in the third state.6. The device of any preceding claim, wherein the indicator comprises incremental subindicators (620b-620e) which are configured to sequentially30 change from a first state to a further state upon incremental elapse of the predetermined duration.349280317. An injection button (14) for a medical pen, wherein the device of any of claims 1 to 6 is incorporated as an integrated part into the injection button.8. A medical pen (10) comprising the device according to any of claims 1 to 6,5 wherein the device is integrated into the medical pen or is attached to the medical pen.9. A medical pen (10) comprising the injection button of claim 7.10 10. A method for indicating a first, second and third state of a medicine comprising:indicating a first state (410) when the medicine has been:maintained in a safe-storage temperature range; anda first use of the medicine has not started; and15 the medicine has not been exposed to immediately intolerable conditions;indicating a second state (220, 320):by temperature-activation when the medicine, or a container that the medicine is contained in, is subjected to a temperature outside of the20 predetermined safe-storage temperature range; andby manual-activation by a user when a first use has commenced; and the medicine has been exposed to temperatures outside the predetermined temperature range; andirreversibly indicating a third state (450) when the medicine has been25 exposed to non-tolerable conditions which renders the medicine unsafe for use;activating a timer (230, 330) with a first predetermined duration contemporaneously upon the medicine, or a container that the medicine is contained in, being subjected to a temperature outside of the predetermined safestorage temperature range and activating a timer with a second predetermined30 duration contemporaneously upon manual-activation by a user when a first use has commenced; andindicating a third state (450) when:34928032the medicine has been exposed to immediately intolerable conditions (413) such that the medicine is unusable;the first predetermined duration of the timer has elapsed; or the second predetermined duration of the timer has elapsed.511. The method of claim 10, wherein indicating the first state, indicating the second state, and indicating the third state comprises visual indication.12. The method of claim 10 or 11, further comprising:10 providing an indicator in a first colour to indicate that the medicine is in the first state;changing the indicator from the first colour to a second colour to indicate that the medicine is in a second state;changing the indicator from the second colour to a third colour, or providing15 a second indicator, to indicate that the medicine is in the third state.13. The method of any of claims 10 to 12, further comprising indicating elapse of incremental periods of the predetermined duration.Patentkrav1. En hybrid enhet (1A, 1B) for å indikere en første, en andre og en tredje tilstand til en medisin omfattende:en enkelt temperaturaktivert og manuelt aktivert indikator (610, 620, 630, 640) for å indikere kun én av de første, andre og tredje tilstandene, idet indikatoren har en manuell aktuator for å endre tilstanden til indikatoren manuelt av en bruker og er konfigurert til å endre tilstand som respons på en termo-kjemisk reaksjon;indikatoren er konfigurert til å:vise en første tilstand når medisinen er:oppbevart innenfor et sikkert lagringstemperaturområde; og en første bruk av medisinen har ikke startet; og medisinen har ikke blitt utsatt for umiddelbart utålelige forhold; og irreversibelt endre tilstand for å vise den andre tilstanden ved temperaturaktivering når medisinen, eller en beholder som medisinen er inneholdt i, blir utsatt for temperaturer utenfor det sikre lagringstemperaturområdet; ogirreversibelt endre tilstand for å vise den andre tilstanden ved manuell aktivering av en bruker når en første bruk har startet; og en timer konfigurert med en første forhåndsbestemt varighet lik utløpstiden for medisinen etter eksponering for ikke-sikre lagringstemperaturer, og en andre forhåndsbestemt varighet lik holdbarheten til medisinen etter første bruk;hvori timeren er konfigurert til å bli irreversibelt aktivert med den første forhåndsbestemte varigheten samtidig med den temperaturaktiverte tilstandsforandringen til indikatoren, og irreversibelt aktivert med den andre forhåndsbestemte varigheten samtidig med den manuelt aktiverte tilstandsforandringen til indikatoren;hvori indikatoren videre er konfigurert til å:irreversibelt endre for å vise den tredje tilstanden ved utløp av den første forhåndsbestemte varigheten eller den andre forhåndsbestemte varigheten til timeren for å gi indikasjon på at den første eller andre forhåndsbestemte varigheten har utløpt, noe som gjør medisinen ubrukelig; og irreversibelt endre for å vise den tredje tilstanden ved eksponering av medisinen for umiddelbart utålelige forhold slik at medisinen er ubrukelig.342. Enheten ifølge krav 1, hvori indikatoren er en visuell indikator.3. Enheten ifølge krav 1 eller 2, hvori indikatoren er en kjemisk basert indikator og timeren er en hybrid kjemisk basert og en elektronisk timer.4. Enheten ifølge et hvilket som helst av kravene 1 til 3, hvori medisinen er insulin og hvori:det forhåndsbestemte sikre lagringstemperaturområdet er 2°C til 8°C; den første forhåndsbestemte varigheten, lik utløpstiden for medisinen etter eksponering for ikke-sikre lagringstemperaturer, er i området 4 til 6 uker;den andre forhåndsbestemte varigheten, lik holdbarheten til medisinen etter første bruk, er i området 4 til 6 uker; oghvori utålelige forhold omfatter eksponering for temperaturer under frysepunktet og/eller over 30 grader.5. Enheten ifølge et hvilket som helst av kravene 2 til 4, hvori den visuelle indikatoren videre er konfigurert til å være:en første farge når den visuelle indikatoren er i den første tilstanden;en andre farge når den visuelle indikatoren er i den andre tilstanden; og en tredje farge når den visuelle indikatoren er i den tredje tilstanden.6. Enheten ifølge et hvilket som helst av de foregående kravene, hvori indikatoren omfatter inkrementelle subindikatorer (620b-620e) som er konfigurert til å sekvensielt endre fra en første tilstand til en videre tilstand ved inkrementelt utløp av den forhåndsbestemte varigheten.7. En injeksjonsknapp (14) for en medisinsk penn, hvori enheten ifølge et hvilket som helst av kravene 1 til 6 er integrert som en del av injeksjonsknappen.8. En medisinsk penn (10) omfattende enheten i henhold til et hvilket som helst av kravene 1 til 6, hvori enheten er integrert i den medisinske pennen eller er festet til den medisinske pennen.359. En medisinsk penn (10) omfattende injeksjonsknappen ifølge krav 7.10. En fremgangsmåte for å indikere en første, andre og tredje tilstand til en medisin omfattende:indikere en første tilstand (410) når medisinen har blitt:oppbevart innenfor et sikkert lagringstemperaturområde; og en første bruk av medisinen har ikke startet; ogmedisinen har ikke blitt utsatt for umiddelbart utålelige forhold; indikere en andre tilstand (220, 320):ved temperaturaktivering når medisinen, eller en beholder som medisinen er inneholdt i, blir utsatt for en temperatur utenfor det forhåndsbestemte sikre lagringstemperaturområdet; ogved manuell aktivering av en bruker når en første bruk har startet; og medisinen har blitt utsatt for temperaturer utenfor det forhåndsbestemte temperaturområdet; ogirreversibelt indikere en tredje tilstand (450) når medisinen har blitt utsatt for ikke-tolerable forhold som gjør medisinen utrygg for bruk;aktivere en timer (230, 330) med en første forhåndsbestemt varighet samtidig som medisinen, eller en beholder som medisinen er inneholdt i, blir utsatt for en temperatur utenfor det forhåndsbestemte sikre lagringstemperaturområdet og aktivere en timer med en andre forhåndsbestemt varighet samtidig ved manuell aktivering av en bruker når en første bruk har startet; ogindikere en tredje tilstand (450) når:medisinen har blitt utsatt for umiddelbart utålelige forhold (413) slik at medisinen er ubrukelig;den første forhåndsbestemte varigheten til timeren har utløpt; eller den andre forhåndsbestemte varigheten til timeren har utløpt.11. Fremgangsmåten ifølge krav 10, hvori indikasjon av den første tilstanden, indikasjon av den andre tilstanden, og indikasjon av den tredje tilstanden omfatter visuell indikasjon.12. Fremgangsmåten ifølge krav 10 eller 11, videre omfattet:36gi en indikator i en første farge for å indikere at medisinen er i den første tilstanden;endre indikatoren fra den første fargen til en andre farge for å indikere at medisinen er i den andre tilstanden;endre indikatoren fra den andre fargen til en tredje farge, eller gi en andre indikator, for å indikere at medisinen er i den tredje tilstanden.13. Fremgangsmåten ifølge et hvilket som helst av kravene 10 til 12, videre omfattet indikasjon av utløp av inkrementelle perioder av den forhåndsbestemte varigheten.
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Patent classes

IPC classesB65D 79/02G01N 31/22G04F 1/00G04F 3/00CPC classesB65D 79/02G01N 31/229G04F 1/00G04F 3/00

Citations

EP 2990792 A1 (A1)US 2011/0121023 A1 (A1)WO 03/087955 A1 (A1)NO 321426 B1 (B1)

Applicants, owners and inventors

Owners
CMEYE AS
Uranienborg terrasse 10 0351 OSLO NO (OSLO Municipality, Oslo county)Org. number: 926356313Inventors
Firouz Rezvani Dehaghani
Niels Juels gt 47 0259 OSLO NO (OSLO Municipality, Oslo county)
Davoud Tayebi
Uranienborg terrasse 10 0351 OSLO NO (OSLO Municipality, Oslo county)
Lars Kilaas
Skansegata 17 C 7014 TRONDHEIM NO (TRONDHEIM Municipality, Trøndelag county)

Agent

BRYN AARFLOT AS
BRYN AARFLOT AS

Org. number: 979993269

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Open in The Brønnøysund Register Centre
Stortingsgata 8 0161 OSLO NO (OSLO Municipality, Oslo county)
Org. number: 979993269
Reference: 141969

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