WO2025202252A1 - Electronic vial cap for tracking vial - Google Patents

Abstract

The present disclosure relates to an electronic vial cap (1) for attachment onto the top of a vial (2), comprising: a rigid housing (11), the housing (11) comprising attachment means (12) to releasably attach the electronic vial cap (1) to the top of a vial (2); and an electronic module arranged in the housing (11) comprising: a sensor system configured to measure environmental conditions comprising a temperature sensor and/or a humidity sensor, a wireless radio communications module, and a control module, wherein the control module is configured to: transmit, to a wireless reader, a status message comprising measurement values from the sensor system.

Description

ELECTRONIC VIAL CAP FOR TRACKING VIAL

FIELD OF THE DISCLOSURE

The present disclosure relates to an electronic vial cap for attachment onto the top of a vial, the electronic vial cap configured to track the environmental conditions the vial is subject to.

BACKGROUND OF THE DISCLOSURE

Vials are typically filled with active ingredients, such as drugs or medicaments, which may be sensitive to environmental conditions, in particular temperature. When the vials containing these active ingredients are stored in hot or cold places, they can become unstable or even degrade, which may pose a risk of negative side-effects or reduced effectiveness of the drugs. As a result, it is required of many types of medication that they are monitored and experience only temperature within a particular temperature range, for example within 20 °C to 25 °C. Further, few medications remain stable in warm conditions of 34 °C or higher. Antibiotics, for example, are notoriously temperaturesensitive, with few antibiotics considered stable in warmer climates.

Depending on the type of medication, it may leave its recommended temperature range for a short duration, for example while being shipped. This is known as a permitted excursion, however may be subject to strict time-limits and temperatures.

To ensure that a vial has not been subject to adverse environmental conditions, it is therefore important to monitor the environmental conditions to which the vial is subject in a reliable and verifiable manner.

Known solutions exist, for example logging devices which are placed in a container or box which stores multiple vials. The logging devices are capable of recording the environmental conditions, in particular temperature. Prior to administration of the temperature, the logging device can be consulted or its data store read out or otherwise analyzed to determine whether the vials stored in the container along with the logging device are still permitted to be administered.

A disadvantage of such logging devices is that the temperature they measure is considered as applying to all vials in the container, which may not always be the case. Further, the logging devices do not prevent the exchange or swapping of vials in the container, meaning that just because the logging device has not recorded any adverse environmental conditions does not mean that the vials currently in the container, immediately prior to administration, are in fact those which were being logged.

Heat tags are also known, which are thin and glued onto vials in the form of a label. These heat tags change color when a specific temperature is exceeded. However, because they have no logic they cannot determine for how long a particular temperature was exceeded for, which may be relevant for medicaments which have a permitted excursion as mentioned above.

Other devices are also known in the form of labels, which are glued to the outside of the vials. These devices may include a temperature sensor and electronics for storing the temperature, however they all suffer from one or several drawbacks.

For example, so-called RFID tags often have no internal power source, requiring a nearby device to energize them such that temperature measurements can be performed and data read from the devices. Such RFID tags are not always practical because they cannot continuously log a temperature without a nearby reader. Active RFID tags are known in the form of labels, but they are often too thick, leading to unnecessarily bulky vials, which do not work with standard manufacturing, shipping or storage systems typically used for vials. SUMMARY OF THE DISCLOSURE

It is an object of the disclosure and embodiments disclosed herein to provide an electronic vial cap for attachment onto the top of a vial.

In particular, it is an object of the disclosure and embodiments disclosed herein to provide an electronic vial cap for attachment onto the top of a vial as defined by the features of the independent claim, which does not have at least some disadvantages of the prior art. Further advantageous embodiments of the disclosure are set forth in the dependent claims.

The electronic vial cap for attachment onto the top of a vial comprises a rigid housing providing an enclosure. The housing comprises attachment means to releasably attach the electronic vial cap to the top of a vial. The electronic vial cap includes an electronic module arranged in the housing. The electronic module comprises a sensor system configured to measure environmental conditions comprising a temperature sensor and/or a humidity sensor. The electronic module comprises a wireless radio communications module configured for wireless radio communication and a control module. The control module is connected to the sensor system and the communication module. The control module is configured to record, in a non-volatile memory of the control module, measurement values received from the sensor system. The control module is configured to transmit, to a wireless reader, using the wireless radio communications module, a status message comprising the measurement values.

The vial is, in an embodiment, a 10R vial (24mm x 30mm).

The vial may be a screw vial, lip vial, or crimp vial.

The vial may be made of glass or plastic, for example. A plastic vial may have another type of closure system, such as a hinge cap (flip-top vial or snap cap vial). The vial is in particular a vial for medicaments, active ingredients, biologically active materials or compounds, etc. The contents of the vial may be in liquid, powder, or tablet form, for example.

In an aspect, the electronic vial cap may be configured for attachment onto the top of a fluid container (e.g., a bottle).

In an embodiment, the housing extends in axial direction and includes a base, a cylindrical wall extending from the base axially, and a top cap arranged at a defined distance from the base, thereby forming a substantially cylindrical enclosure inside the housing.

The base and cylindrical wall of the housing are preferably integrally formed (i.e. they are one piece). For example, the base and cylindrical wall of the housing may be formed of a plastic material by injection molding. The top cap is preferably bonded to a top edge of the cylindrical wall.

In an embodiment, the electronic vial cap further comprises a skirt extending from the housing in the opposite axial direction, the skirt comprising engagement means for engagement with a vial head of the vial. Additionally or alternatively, the electronic vial cap may comprise an adhesive layer on the bottom of the housing for attachment to the top of the vial.

In an embodiment, the electronic module is arranged on a printed circuit board (PCB) arranged in the housing. In particular, the PCB may be implemented as a circular PCB, arranged plane parallel to the base. The PCB may have has a size and shape substantially corresponding to the circular cross-section of the base and/or the inner cross-sectional area defined by the cylindrical wall. Thereby, the edge of the printed circuit board may engage with the cylindrical wall. In an embodiment, the housing includes one or more supports arranged in the enclosure and configured to support the printed circuit board at a defined distance from the base.

The supports may be arranged on the inner surface of the cylindrical wall, preferably in the form of protrusions, which are distributed circumferentially around the inner surface of the cylindrical wall. Each protrusion defines a flat edge (i.e. a ledge) extending in circumferential direction, the flat edges each at the same distance from the base.

The supports may additionally or alternatively be arranged extending from the base, for example in the form of pillars, the supports each extending the same defined distance from the base.

In an embodiment, the sensor system is arranged, on an upper side of the printed circuit board facing in axial direction, at a defined location. The base comprises a sensor system support extending from the base to the bottom side of the PCB at a location corresponding to the defined location, on the upper side of the PCB, at which the sensor system is arranged.

In an embodiment, the top cap includes an opening designed to allow ambient air to come into contact with the sensor system. The top cap may define a recess within which the opening is arranged. The recess is designed such that the opening is set back from a top surface of the top cap. The recess may have an overall cylindrical shape.

In an embodiment, the opening is arranged above the sensor system and the top cap includes a tubular cylindrical extension around the opening, extending from the top cap towards the sensor system.

In an embodiment, the tubular cylindrical extension in particular extends from the top cap to the PCB and abuts against the PCB around the sensor system, such that the tubular cylindrical extension defines a sensor system cavity in air communication with the environment via the opening, while simultaneously sealing the remaining enclosure from the environment. For example, the sensor system may be implemented in a single package attached to the PCB. The cylindrical extension contacts the PCB around the sensor system.

The tubular cylindrical extension may be sealed and/or bonded to the printed circuit board.

In an embodiment, the electronic system further comprises a tamper detector configured to detect a removal of the electronic vial cap from the vial. The tamper detector may include a switch (e.g. micro-switch) and/or capacitive sensor for determining physical contact between the electronic vial cap and the vial. The tamper detector may include sensing wires arranged in the skirt, which are configured such that the sensing wires are bent, damaged and/or broken when the electronic vial cap is removed from the vial.

In an embodiment, the electronic module further comprises a fill level detector configured to determine a weight and/or a fill level of the vial.

The fill level detector may comprise, for example, an ultrasonic transducer directed downwards towards the interior of the vial. The ultrasonic transducer may be arranged on the bottom side of the PCB. The ultrasonic transducer is preferably coupled directly to the bottom of the housing to reduce the acoustic impedance between the ultrasonic transducer and the interior of the vial. The direct coupling may be by way of direct contact between the ultrasonic transducer and the housing, or by way of a coupling member arranged between the ultrasonic transducer and the housing.

In an embodiment, the electronic system further comprises an inertial measurement unit. The control module is further configured to receive, from the inertial measurement unit, motion data. The control module is configured to determine, using the motion data, whether the electronic vial cap is in motion, in particular by comparing the motion data with one or more defined motion thresholds. The control module is configured to switch, from a first mode to a second mode, if the electronic vial cap is in motion. The control module is configured to transmit the status message with a defined first periodicity in the first mode and a defined second periodicity in the second mode, which first periodicity and second periodicity are different. In particular, in the first mode, the periodicity is lower than in the second mode. Thereby, the status message is transmitted more frequently when the electronic vial cap is in motion.

In an embodiment, the electronic vial cap further comprises a battery compartment configured to receive a battery. The battery compartment is preferably arranged underneath the PCB, in particular arranged between the base and the PCB.

The battery compartment may be designed to receive a coin cell battery. In particular, the underside of the PCB may include receiving members designed to engage and electrically contact the coin cell battery.

The battery compartment may include a battery. The battery compartment may be configured to house a coin battery (e.g. a CR2032), a paper battery or any other kind of battery. The battery arranged in the battery compartment may be configured to provide the electric power to the electronic vial cap, in particular depending on the application of the electronic vial. The battery may further be at least partially made of an ecological friendly material. Further, the battery may have a battery capacity in the range from 5 mAh to 300 mAh, preferably from 8,4 mAh to 200 mAh. The battery may have a battery capacity of 8,4 mAh or 200 mAh.

In an alternative embodiment, which does not include the battery compartment, the electronic vial cap may include electrical contacts for receiving electrical energy from an external battery, in particular a battery arranged on an outside surface of the vial. In an embodiment, the wireless radio communications module and the control module are implemented in a single system in a package (Si P) , enclosed in a single chip carrier package.

In an embodiment, the SiP is arranged on the PCB, preferably on the upper side.

In an embodiment, the control module is further configured to determine, using the measurement values, a maximum and/or a minimum value of the recorded temperature and/or the recorded humidity. The control module is further configured to transmit the status message including the maximum and/or the minimum value(s).

In an embodiment, the wireless radio communications module is configured to implement a Bluetooth protocol.

In an embodiment, the control module is configured to transmit, using the wireless radio communications module, the status message in a Bluetooth Low Energy frame.

In an embodiment, the engagement means of the skirt comprise a plurality of latches arranged circumferentially around the skirt for engagement with the vial.

In an embodiment, the engagement means of the skirt comprise a screw thread for engagement with a screw thread of the vial head of the vial.

In an embodiment, the electronic vial cap further comprises a stopper arranged inside the skirt configured to engage against the vial head of the vial.

In an embodiment, the electronic vial cap further comprises a vial cap arranged inside the stopper configured to engage with the vial head of the vial for sealing the vial. In addition to the electronic vial cap, the present disclosure also relates to a vial having fitted thereon an electronic vial cap as described herein.

It is further an object of the present disclosure to provide an electronic cap for attachment to a vessel, container, or receptacle, or more generally a hollow container with an opening. The vessel may be designed to contain, for example, a fluid (e.g., a beverage). The electronic cap comprises a rigid housing providing an enclosure. The housing comprises attachment means to releasably attach the electronic cap to the top of a vessel. The electronic cap includes an electronic module arranged in the housing. The electronic module comprises a sensor system configured to measure environmental conditions comprising a temperature sensor and/or a humidity sensor. The electronic module comprises a wireless radio communications module configured for wireless radio communication and a control module. The control module is connected to the sensor system and the wireless radio communications module . The control module is configured to record, in a non-volatile memory of the control module, measurement values received from the sensor system. The control module is configured to transmit, to a wireless reader, using the wireless radio communications module , a status message comprising the measurement values.

In an embodiment, the electronic cap includes one or more further features described herein with reference to the electronic vial cap.

BRIEF DESCRIPTION OF THE DRAWINGS

The herein described disclosure will be more fully understood from the detailed description given herein below and the accompanying drawings, which should not be considered limiting to the invention described in the appended claims. The drawings in which:

Fig. 1 shows a perspective view of an electronic vial cap fitted onto a vial; Fig. 2 shows a side view of an electronic vial cap fitted onto a vial;

Fig. 3 shows a side section view of an electronic vial cap fitted onto a vial;

Fig. 4 shows a perspective view of an electronic vial cap;

Fig. 5 shows a perspective view of part of the housing of an electronic vial cap, in particular the housing without the top cap;

Fig. 6 shows a perspective view of the top side of the top cap;

Fig. 7 shows a perspective view of the bottom side of the top cap;

Fig. 8 shows a front view of the top cap;

Fig. 9 shows a bottom view of the top cap;

Fig. 10 shows a perspective view of an electronic module implemented on a PCB;

Fig. 11 shows a top view of an electronic module implemented on a PCB;

Fig. 12 shows a side view of an electronic module implemented on a PCB;

Fig. 13 shows a bottom view of the top cap;

Fig. 14 shows a block diagram schematically illustrating an electronic vial cap;

Fig. 15 shows a block diagram schematically illustrating the sensor system;

Fig. 16 shows a block diagram schematically illustrating the electronic module; and

Fig. 17 shows a flow diagram illustrating a method performed by the electronic vial cap. DESCRIPTION OF THE EMBODIMENTS

Reference will now be made in detail to certain embodiments, examples of which are illustrated in the accompanying drawings, in which some, but not all features are shown. Indeed, embodiments disclosed herein may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Whenever possible, like reference numbers will be used to refer to like components or parts.

Figure 1 shows a perspective view of an electronic vial cap 1 . The electronic vial cap 1 is a device configured to fit or attach onto the top of a vial 2.

The electronic vial cap 1 is in particular designed to fit or attach onto the vial 2 in a removable or releasable manner, such that the electronic vial cap may be fitted, attached or otherwise secured to the vial 2 and then, at a later time-point, removed. In particular, the electronic vial cap 1 is designed to fit onto the top of the vial 2, for example by clasping onto the vial head of the vial 2.

The electronic vial cap 1 is preferably designed such that it may be fitted onto the vial 2 in an automated manner, e.g., by external equipment configured to attach the electronic vial cap 1 to the vial 2. This step of attachment is performed, for example, in a manufacturing, bottling, or logistics facility in which the vial 2 is filled with its contents or otherwise prepared. To this end, the electronic vial cap 1 may include holding members such that external equipment may temporarily hold the electronic vial cap 1 for purposes of attachment to the vial 2.

The electronic vial cap 1 may in particular be configured such that it can be removed from the vial 2 manually, i.e. by hand by a person, and not require and specialized devices, tooling or equipment for removal. The electronic vial cap 1 may be designed to include a tamper evident component or tamper detecting component. The tamper evident component is a structural feature of the electronic vial cap 1 , which is permanently and visibly altered after removal of the electronic vial cap 1 from the vial 2. The visible alternation may be caused by deformation, snapping, bending or breaking of the tamper evident component, in particular through application of a force required to remove the electronic vial cap 1 from the vial 2. Thereby, it can be checked, alone by visual inspection, whether the electronic vial cap 1 has already been removed from the vial 2 (or another vial 2). This ensures that the electronic vial cap 1 cannot be used more than once. It further ensures that the electronic vial cap 1 cannot be removed, the vial 2 or its contents tampered with, and the electronic vial cap 1 re-attached to the vial 2.

The tamper evident component may be designed such that, after the electronic vial cap 1 has been removed from the vial 2, it is no longer possible to re-attach the electronic vial cap 1 to the vial 2.

The electronic vial cap 1 preferably has an overall substantially cylindrical shape, preferably with an outer diameter which closely corresponds to an outer diameter of the vial. The electronic vial cap 1 is designed to attach over and thereby cover the top of the vial 2.

The vial 2 is in particular a small tubular vessel, for example made of glass or plastic. The vial 2 has a top part, which includes, for example, a screw, lip, or crimp. These kinds of vials 2 are typically called “screw vials”, “lip vials”, and “crimp vials”, respectively. The vial 2 may be closed by a closure, such as a screw cap, a stopper, or a septum with a cap, respectively. Other closure types are also foresee, for example a hinge cap, such as in a flip-top vial or a snap cap vial. The electronic vial cap 1 may comprise the closure for the vial 2. Alternatively, the vial 2 includes the closure.

The vial 2 is in particular designed to carry a substance used for medical treatment. For example, a drug, chemical, or biologically active agent. The substance may be in a liquid, tablet, or aggregate form (e.g., powder form). The vial 2 is preferably filled with the substance prior to being closed by means of the closure.

The vial 2 as shown includes a main section 21 with a circular cylindrical shape. Towards the top of the main section 21 , the vial 2 narrows in a neck portion 22 in which the vial 2 has a smaller outer diameter than in the main section 21 . A shoulder 23 separates the main section 21 from the neck portion 22. Above the neck portion 22, the vial 2 ends in a vial head 24 (also referred to as a collar or neck finish). The vial head 24 may have an outer diameter similar to that of the main section 21. The vial 2 is closed by a closure (not shown).

The vial 2 may be implemented as a 10R vial, which has dimensions of o 24.0 x 45 x 1.00 mm. The electronic vial cap 1 designed for fitting onto the 10R vial may consequently have dimensions such that it fits on top of the 10R vial without causing the overall dimensions of the overall package (i.e., the electronic vial cap 1 fitted to the vial 2) to be significantly larger than the vial 2 itself. In particular, the electronic vial cap 1 may have an overall height (i.e. its extension along the center line) of between 10 mm to 30 mm, and an outer diameter of between 24 mm and 30 mm. Preferably, the electronic vial cap 1 extends by a height of between 5 mm and 15 mm above the top of the vial 2.

Other forms of vials 2 are known. For example, depending on the vial 2, the vial head 24 may have an outer screw thread for engagement with a complementary screw thread of a closure. The electronic vial cap 1 includes a housing 1 1 . The housing 1 1 is a cylindrical structure with a central axis D. The central axis D is also the central axis of the vial 2.

The housing 11 includes attachment means 12 designed to attach the electronic vial cap 1 to the vial 2 in a removable/releasable manner. The attachment means 12 may include a plurality of latches as shown which are designed to engage with the bottom of the vial head 24 such as to securely attach the electronic vial cap 1 to the vial 2.

The housing 1 1 may comprise a skirt 14, which is a annular or cylindrically shaped section which extends, from the base 1 11 , in the axial direction downwards. In particular, the skirt 14 is designed to at least partially encompass the vial head 24. The skirt 14 may comprise, have attached thereto, and/or have extending therefrom, the engagement means 12. For example, the engagement means may be implemented as latches 12 as shown. Alternatively or additionally, the engagement means may be implemented by way of a screw thread arranged on an inside surface of the skirt 14.

Figure 2 shows a side view of the electronic vial cap 1 attached to the vial 2. It can be seen that the overall profile of the electronic vial cap 1 does not significantly increase the size of the vial 2. This ensures that the electronic vial cap 1 does not increase packaging requirements for the vial 2.

Figure 3 shows a lateral section side view of the electronic vial cap 1 attached to the vial 2, in particular a section view through the center line D. It is shown how the attachment means 12 implemented as latches 121 achieve a releasable annular snap-fit connection utilizing hoop-strain around the neck 22 of the vial and abut against the bottom of the vial head 24.

The vial 2 includes a closure, which comprises a stopper 25 and a cap 26. The stopper 25 partially inserts into the neck of the vial 2 and is preferably made of an elastomer, thereby sealing the vial 2 and securing the contents of the vial 2. A cap 26 is fixed on top of the stopper 25. The cap 26 may be made of plastic or metal and provides extra protection to the stopper 25.

The engagement means 12 are implemented as a plurality of latches 121 in an annular arrangement. In other words, several latches 121 (preferably, between 3 and 8 latches 121 ) are circumferentially distributed extending downwards, substantially in parallel with the center line D, from the top part of the vial 2 to the neck 22 of the vial 2.

Each latch 121 includes a flexible upper arm 122 and a latch lobe 123. The latch lobe 123 is designed to have a first chamfer 124, fillet, radius, or otherwise shaped inner edge such that the latch 121 is pushed outwards when the electronic vial cap 1 is pushed down on top of the vial 2, such that the electronic vial cap 1 can be secured to the vial 2.

The latch 121 may include a second chamfer 125, fillet, radius, or otherwise shaped inner edge on an upper part of the lower latch lobe 123 such that the electronic vial cap 1 may be removed from the vial 2 when pulled, in particular by hand.

In an embodiment, the latch 121 may include a pre-determined breaking region, in particular in the flexible upper arm 122, which is designed to snap or break, separating the main part of the electronic vial cap 1 , in particular the main part of the housing 11 , from the lower latch lobe 123 when the electronic vial cap 1 is removed from the vial 2. The breaking region may be formed by cuts, slits, perforations or other means of implementing a structural weakening of the flexible upper arm 122. In particular, the latch 121 according to this embodiment does not include a second chamfer 124 of the upper part of the lower latch. Rather, the upper part of the lower latch lobe 123 is designed such that it substantially conforms to the outside surface of the vial 2, in particular in a region between the neck 22 and the vial head 24. The housing 11 is designed to form an enclosure 13. The enclosure 13 is a chamber which is substantially closed off from the outside. Specifically, the enclosure 13 is designed to be sealed from the outside, with the exception of particularly defined openings as described herein. Thereby, the enclosure 13, in particular contents or components arranged in the enclosure 13, are protected from physical damage, manipulation, or exposure to the elements.

The enclosure encloses the electronic module 3. The electronic module 3 may be include a printed circuit board (PCB) 31 and electronic components attached to the PCB 31 . The PCB 31 is preferably a circular PCB 31 may extend laterally across the enclosure 13 between the cylindrical wall 1 12. The PCB 31 preferably has a size and/or shape, which substantially corresponds to the size and/or shape of the circular cross-section of the base 11 1 and/or the inner cross-sectional area defined by the cylindrical wall 1 12. Thereby, the outer edge of the PCB 31 may engage, or touches, the cylindrical wall 1 12.

The electronic module 3 may comprise components attached, e.g., soldered or otherwise mounted, to the top side of the PCB 31 . The electronic module 3 may further comprise components attached, arranged or mounted to the bottom side of the PCB 31. In particular, a battery holder is arranged on the bottom side (underside) of the PCB 31 , in particular in a space formed between the base 111 and the PCB 31 .

The housing 11 includes a base 1 11. The base 111 extends radially from the center line D and abuts against the top of the vial 2, for example the closure (e.g., the stopper 25 or the cap 26). The base 1 11 may have a substantially circular disc shape. The engagement means 12 extend from the bottom of the base 1 11.

The housing 11 further includes a cylindrical wall 112 which extends from the base 11 1 , in particular from an outer edge of the base 11 1 , in an axial direction (i.e., upwards from the base 11 1 ). The base 1 11 and the cylindrical wall 112 thereby form an open cylindrically shaped enclosure 13.

The housing 11 comprises a top cap 1 13. The top cap 113 covers the enclosure 13, extending between the cylindrical wall 112 opposite the base 1 11. The top cap 113 may be bonded or otherwise securely attached to the housing 11. The top cap 113 is in particular arranged at a defined distance, in the direction of the center line D, from the base 11 1.

The components of the housing 11 , e.g., the attachment means 12, the base 11 1 , and the cylindrical wall 112 are, in an embodiment, integrally formed. In other words, they are manufactured as a whole, for example by injection molding. The components of the housing are preferably made of a plastic material.

The top cap 1 13 may also be made of a plastic material and formed using injection molding.

Figure 4 shows a perspective view of the electronic vial cap 1 . In particular, a recess 1 14 in the top cap 1 13 is shown. As is explained herein in more detail, the recess 1 14 includes an opening 1 17 which allows ambient air to enter the enclosure 13, or at least part thereof.

Figure 5 shows a perspective view of the electronic vial cap 1 with the top cap removed. Further, the electronic module 3 is omitted. The components of the electronic vial cap 1 shown in the figure may be e.g. obtained in a single injection molding step or in a plurality of injection molding steps.

The interior of the enclosure 13 is shown, formed by the cylindrical wall 1 12 and the base 1 1 1. The housing 11 includes one or more PCB supports 115 arranged on the edge of the cylindrical wall 1 12. The PCB supports 1 14 may extend from, or form part of, the base 11 1 and/or the cylindrical wall 1 12. The PCB supports 1 15 are members or protrusions which each protrude from the cylindrical wall 112 and/or the base 1 11 by a defined distance from the base 11 1 in the positive D direction (i.e. along the central axis D). For example, the protrusions define a flat edge parallel to the base 1 11. Thereby, the PCB supports 1 15 define a planar surface. The PCB (not shown) is arranged on top of the PCB supports 115. Thereby, the PCB achieves a plane parallel orientation to the base 11 1.

The base 11 1 as shown has beams running across it in a square grid pattern. The beams provide additional structural support for the base 11 1.

The PCB supports 114 may additionally or alternatively be arranged extending from the base 11 1 , for example in the form of pillars, the PCB supports 1 15 each extending the same defined distance from the base.

The housing 11 comprises a sensor system support 1 16. The sensor system support 1 16 is a member, for example in the form of a pillar, which extends from the base 11 1 in the axial direction (i.e. in the direction of the center line D). The sensor system support 1 16 has a defined location on the base 111 , which is designed to correspond to the position, on the PCB, of the sensor system included in the electronic module 3. Further, the sensor system support 1 16 may be arranged at a location corresponding to the location, in the top cap 113, of the opening 1 17 (in particular the opening 117 in the recess 1 14). In other words, the sensor system support 1 16 and the opening 117 (not shown) are arranged on top of each other, or line up, in the direction of the center line D.

Figure 6 shows the top cap 1 13 of the housing 11 . As described above with reference to Fig. 4, the top cap 113 has a recess 1 14 defined as groove which has a surface set back from the surface of the top cap 1 13. In the recess 114, an opening 117 is arranged, the opening extending through the top cap 113. In other words, the opening 1 17 is a through bore through the top cap 1 13, which allows for gas exchange through the top cap 1 13.

Figure 7 shows the bottom side of the top cap 1 13. In particular, the bottom side as shown has beams running across it in a square grid pattern. The beams provide additional structural support for the top cap 1 13.

The top cap 113 further has an extension 1 18 in the form of a cylindrical tube. The extension 1 18 extends, from the bottom surface of the top cap 113, in the axial direction. The tubular cylindrical extension 118 is arranged around the opening 117, in particular the opening 117 is arranged in the top cap 1 13 inside, i.e. within the bounds of the tubular cylindrical extension 1 18, specifically in an area on the top cap 1 13 circumscribed by the tubular cylindrical extension 118. In other words, the tubular cylindrical extension 1 18 forms a wall, in particular a circular wall, around the opening 1 17.

The tubular cylindrical extension 118 may extend by a defined distance from the bottom surface of the top cap 113. Specifically, the tubular cylindrical extension 1 18 has a height (i.e. extension) such that, when the top cap 113 is attached onto the cylindrical wall 112 during manufacture, the tubular cylindrical extension 1 18 abuts against the PCB 31. Thereby, the tubular cylindrical extension 1 18 and the PCB 31 define a sub-compartment inside the enclosure 13 into which ambient air can enter. The tubular cylindrical extension 1 18 and the PCB 31 separate this sub compartment from the remainder of the enclosure 13, thereby ensuring that other electronic components of the electronic module 3 protected from ambient air and the environment. As is mentioned in detail below, the electronic module 3 comprises a sensor system which is arranged (for example on the PCB 31 ), such that the sensor system is inside the tubular cylindrical extension 1 18 and thereby exposed, via the opening 117, to ambient air. The tubular cylindrical extension 118 may be sealed against or bonded with the PCB 31 to improve the seal.

Figure 8 shows a top view of the top cap 1 13. In particular, this view shows how the recess 114 extends from both the top surface of the top cap 113, as well as from the side of the top cap 1 13. In other words, the recess 114 in the form of a groove extends from the edge of the top cap 1 13. This ensures that, even if the top cap 1 13 is covered, for example by having another object, in particular another vial 2, stacked on top of it, the opening 117 is not cut off from the environment but ambient air can continue to be exchanged via the groove/channel, which extends to the edge of the top cap 113.

Figure 9shows a bottom view of the top cap 113. In particular, the tubular cylindrical extension 1 18 is visible with the opening 117 arranged within it. Further, bond lines 119 are shown. The bond lines 119 are areas where the top cap 1 13 will be bonded to the cylindrical wall 112 and the PCB 31 , thereby sealing the enclosure 13. The bond lines 1 19 may include a bonding agent.

Figure 10 shows a perspective view of the top side of the electronic module 3. The electronic module 3 is implemented on, or comprising, a PCB 31. Specifically, at least some of the components of the electronic module 3 are arranged on the PCB 31 , either on the top side of the PCB 31 or the bottom side of the PCB 31 . Further components of the electronic module 3 not arranged on the PCB 31 may be electrically connected to the PCB 31 , for example by way of wires or leads.

The components of the electronic module 3 attached to the PCB 31 may be attached via bonding and/or soldering. The PCB 31 thereby provides common electrical infrastructure, in particular for power supply and data communication between the components of the electronic module 3. In particular, the PCB 31 may provide for one or more supply voltage planes or traces, one or more ground planes or leads, as well as electric traces, which provide or enable for analogue and/or digital communication between components of the electronic module 3.

The electronic module 3 in particular comprises a sensor system 32, a control module 33, and a wireless radio communications module 34.

The control module 33 comprises a processing unit and a memory, as is described below in more detail.

The sensor system 32 may include a temperature sensor and/or a humidity sensor, preferably integrated into a single electronic component attached to the PCB 31 . As described herein, the sensor system 32 may comprise additional sensors or components arranged in other locations on the PCB 31 and/or in the electronic vial cap 1 .

The control module 33 and the wireless radio communications module 34 may be integrated into a single system in a package (SiP) 35. The SiP 35 is a single, discrete electronic module, which is attached to the PCB 31 as a single component. The SiP 35 may be implemented using an RLS10 chip from onsemi, as described herein.

The SiP 35 comprises, as described, multiple discrete electronic components, which may each be implemented as discrete chips or dies. Further, the SiP 35 comprises analog circuitry, in particular in the wireless radio communications module 34 in which the analog circuitry comprises digital to analog converters (DACs) and amplifiers. The SiP may further comprise an antenna connected to the wireless radio communications module 34. Figure 11 shows a top view of the electronic module 3 described above with reference to Fig. 10.

Figure 12 shows a bottom view of the electronic module 3 described above with reference to Fig. 11 . In particular, the PCB 31 is shown with the SiP 35 arranged on the top side, and a battery compartment 36 arranged on the bottom side. The battery compartment 36 is arranged between the base 11 1 and the PCB 31 when the electronic module 3 is manufactured.

The battery compartment 36 may be arranged, as shown, to receive a battery, for example a coin cell battery. In particular, the battery compartment 36 may include receiving members designed to engage and electrically contact the coin cell battery.

Figure 13 shows a bottom view of the electronic module 3 shown and described with reference to Figs. 10 to 12.

Figure 14 shows a block diagram illustrating schematically an electronic cap, respectively an electronic vial cap 1 , and various components thereof. The electronic cap 1 is attachable to a vessel, in particular a vial as described above with reference to Figs. 1 to 13. While reference will be made to a vial in particular instances, this is intended to be understood as a reference to all manner of vessels, in particular bottles having an opening.

Preferably, the electronic cap 1 is attachable to the vessel mechanically by engagement means, however, additionally or alternatively, the electronic cap 1 may be attached to the vial by bonding, i.e. by use of adhesives.

The electronic vial cap 1 comprises a housing 1 1. The housing is preferably rigid and provides structural support for, and encloses, an electronic module 3. The electronic module 3 comprises a sensor system 32, a control module 33, and a wireless radio communications module 34. The sensor system 32 and the wireless radio communications module 34 are connected to the control module 33 for data exchange.

The control module 33 is implemented for example, as one or more electronic chips, for example one or more integrated circuits, microcontrollers, microprocessors, application specific circuits (ASICs), or the like. The control module 33 further comprises, depending on the embodiment of the invention, analog circuitry configured to measure and/or generate analog signals. Specifically, the control module 33 comprises at least one processing unit and a memory. The control module 33 may further be integrated with the wireless radio communications module 34 in a single chip, for example a radio system on a chip (“Radio SoC”), which may be considered a system in a package SiP 35 which includes the wireless radio communications module 34 as well as a programmable microcontroller.

For example, the electronic vial cap comprises a SiP 35 in the form of an RSL10 chip from ONSEMI which integrates the control module 3 and the wireless radio communications module 34 in chip. The RSL10 further includes, for example power management units, oscillators, flash, and RAM memories, a DMA controller, and peripherals and interfaces necessary for connecting/implementing the sensor system 32 described herein.

The memory comprises volatile (non-persistent) and/or non-volatile (persistent) memory. For example, the memory, in particular the non-volatile memory, is implemented as solid state memory (e.g. flash memory, ReRAM, EEPROM, MRAM, FRAM, etc.). Additionally or alternatively, the memory may further include volatile memory backed up by battery power. The memory is configured to store program code, firmware, software applications, and/or software libraries. Additionally, the memory is configured to store data relating to the aforementioned. The memory stores a configuration file. The configuration file may be set and/or updated as required, in particular by receiving one or more configuration messages from a wireless reader device. The wireless reader device may be a fixedly arranged device, for example installed in a production or logistics facility. The wireless reader device may also be a handheld consumer device, for example a smart phone having appropriate software installed thereon, for communication with the electronic cap 1 .

The configuration file includes, for example, an identifier of the electronic cap 1 , which identifier is, for example, a unique string associated with the electronic cap 1 . The unique string may be associated, in a server, with information relating to details about the vial, its contents, the manufacturer, a date of manufacture, date of shipping, delivery address, etc.

The configuration file may further include environmental value thresholds defining permissible environmental conditions that the vial (respectively its contents) may be subject to (for example without causing the stored contents to lose efficacy). Specifically, the environmental value thresholds may include temperature thresholds (e.g., a maximum temperature and/or a minimum temperature), humidity thresholds (e.g., a maximum relative humidity, and/or a minimum relative humidity). For example, the environmental value thresholds might define a temperature range of 20 °C to 25 °C. The permitted temperature range may depend on the contents of the vial.

The environmental criteria may further define periods or durations for which the maximum and/or minimum temperature/relative humidity may be exceeded. Further, the defined periods or durations may be dependent on the temperature itself, such that a temperature which exceeds the maximum permitted temperature by a larger amount has a correspondingly lower period than a temperature which exceeds the maximum permitted temperature by a lower amount. The control module 33 is configured to carry out one or more steps and/or functions as described herein. Specifically, the memory is configured to store program code (for example, as firmware, software application(s), and/or software libraries) configured to control the processing unit of the control module 33 such that the processing unit carries out one or more of the steps and/or functions as described herein.

In particular, the control module 33 is configured to record, at a regular pre-defined frequency, the environmental measurement values and/or the tamper status indicator. The pre-defined frequency depends on the particular implementation and is configured to be, for example, every second, every 10 seconds, or every minute.

The control module 33 is further configured, for example, to aggregate the environmental measurement values and to store an average value, averaged over a pre-defined timeperiod.

In an embodiment, the control module 33 is further configured to compress or otherwise store the data in an efficient manner. As described above, averaged environmental measurement values can be stored. Additionally, or alternatively, only environmental measurement values deviating from a previously stored value by more than a particular deviation threshold are stored. Similarly, the control module 33 can be configured only to store tamper status indicators, which deviate from a previously stored tamper status indicator. In these embodiments, it is preferable to store each environmental measurement value and the tamper status indicator with an appropriate time stamp.

The control module 33 comprises, in an embodiment, a digital clock (real time clock (“RTC”)) configured to provide a time-stamp indicating a current time. The digital clock may be set upon receiving an appropriate wireless signal from an external device.

The wireless radio communications module 143 is configured for wireless radio communication according to one or more radio communications standards. The wireless radio communications module 143 is configured to provide, e.g., transmit a status message to a wireless reader device. The status message may be transmitted upon interrogation by the wireless reader device. The status message may, additionally or alternatively, be transmitted upon request by the wireless reader device, i.e. upon receiving, from the wireless reader device, a specific request message. Transmission of the status message may depend on affirmative authorization or validation of the specific request message.

The wireless radio communications module 34 may comprise a Bluetooth circuit, in particular a Bluetooth Low Energy (BLE) circuit.

The wireless radio communications module 34 may be configured to transmit data using a standardized protocol, for example BLE. The wireless radio communications module 34 may additionally or alternatively be configured to communicate using a proprietary/custom protocol, in particular designed to reduce the power consumption of the electronic module 3.

The wireless radio communications module 34 may comprise a radio-frequency identification (RFID) circuit. Depending on the embodiment, the RFID circuit includes a low frequency (LF) RFID circuit (for example as defined in the ISO 14223, and ISO/IEC 18000-2 standards), a high frequency (HF) RFID circuit (for example as defined in the ISO 15693 standard), and/or an ultra-high frequency (UHF) RFID circuit (according to the EPCGIobal Gen2 (ISO 18000-63) standard). In an embodiment, the HF RFID circuit is a near-field communication (NFC) circuit (for example, using the ECMA-340 or ISO/IEC 18092 standards).

The wireless radio communications module 34 may comprise a WiFi module and/or modules configured for other wireless communication protocols. The electronic cap further comprises a battery, for example a coin cell battery. The battery may be recharged and/or replaced after running out of power. The battery may have a circular surface area of approximately 1 cm² to 3 cm², depending on the vial type.

The electronic cap may, in addition or alternatively to a battery arranged inside the electronic cap, be electrically connected to an auxiliary battery, the auxiliary battery attached to the vial. The auxiliary battery may in particular be arranged on the outside of the vial, in particular on the outside of the main section of the vial. The auxiliary battery may be used in applications where longer battery life is beneficial. The auxiliary battery may specifically have a battery capacity larger than a battery capacity of a battery internal to the electronic cap, by virtue of the larger volume available.

The auxiliary battery may have an overall curved shape such that it substantially conforms to the outside of the vial, i.e. a cross-section of the auxiliary battery may form a circular arc. Preferably, the auxiliary battery extends halfway around the main section of the vial. The auxiliary battery may have a flexible structure and be attached to the vial by way of an adhesive. The auxiliary battery may alternatively have an at least partially rigid structure and be attached to the vial at least partly by a form fit (e.g., an interference fit, friction fit, etc.).

The auxiliary battery may have dimensions of up to 20.9 cm² or up to 10.2 cm², for example approximately 5 to 9 cm² or 12 to 18 cm². The auxiliary battery may have a thickness of up to 3 mm, for example 1 .5 - 2.5 mm.

The auxiliary battery may have an upper shoulder. The upper shoulder is narrower than a main part of the auxiliary battery. The upper shoulder is configured such that the auxiliary battery sits on a neck section of the vial. On other words, the auxiliary battery has main part with an inner surface which forms part of a circular cylinder (the circular cylinder preferably matching the outer surface of the main section of vial), and also has an upper part forming the upper shoulder which is narrower, such the auxiliary battery may be arranged on the vial by slipping it down over the vial. The auxiliary battery is electrically connected to the electronic tracking cap. The electrical connection may be formed by two wires and/or electric traces connecting the auxiliary battery to the electronic module 3.

In one embodiment, the auxiliary battery includes two exposed electric conductors providing battery connectors. The electronic cap 1 may include two counterpart exposed electric conductors providing tracking cap connectors, in particular arranged on the skirt, such as one or more of the latches (e.g., on an inner surface of the latches, such as the surface of latch lobes 123 or the first chamfer 124 facing inwards), such that when the electronic cap 1 is placed ontop of the vial, the battery connectors electrically contact the tracking cap connectors, thereby enabling the flow of electricity from the battery to the electronic cap 1 .

The electric conductors providing tracking cap conductors are connected to the electronic module by way of wires or electric traces arranged on the inner surface of the skirt, preferably in a recess on the inner surface of the skirt (which recess may be covered to avoid damage to the wires or traces). The wires or traces extend through the base of the housing and are connected to the electronic module.

The wires or traces for connecting the electronic module to the auxiliary battery may, in an embodiment, also form part of an electronic tamper detector as described herein, in particular by providing or implementing the one or more sensing wires.

The battery connectors preferably have an at least partially circular shape extending at least partially around the outside of the vial (preferably on the shoulder and/or neck of the vial), when the auxiliary battery is installed on the vial. The tracking cap connectors are preferably arranged at different axial locations, i.e. one above the other. The tracking cap connectors are configured correspondingly, for example with a first connector arranged at a first axial position on the inner surface of the latch, and a second connector arranged at a second axial position on the inner surface of the latch, different from the first axial position. This arrangement has the advantage that the electronic vial cap 1 can be placed onto the vial in any azimuthal angle and still achieve an electric connection to the battery, which makes for simpler manufacture and also means that the electronic vial cap 1 can be twisted without jeopardizing the electric connection to the auxiliary battery.

The electronic cap is configured such that the power consumption is low and the electronic cap can run for several months without recharging the battery. Specifically, the current draw of the electronic module 3 is less than 2 pA, preferably approximately 1 pA or less.

Figure 15 shows a block diagram illustrating schematically a sensor system 32. The sensor system may be distributed throughout the electronic vial cap 1 . In particular, some sensors may be arranged and/or contained entirely on the PCB 31 , while other sensors may be arranged within parts of the housing 1 1 .

The sensor system 32 is configured to perform measurements using various sensors, which form part of the sensor system 32. The sensor system 32 may perform the measurements upon request (i.e. after receiving an appropriate message or signal from the control module 33), or automatically, for example at defined time-points or time intervals, or based on conditions which may be determined by the sensor system 32 itself. In an example, the sensor system 32 is configured to perform measurements at time intervals between 10 seconds and 10 minutes, preferably every minute to every 5 minutes. The sensor system is configured to provide (e.g., transmit) the measurement values to the control module 33. The measurement values can be provided automatically by the sensor system 32 and/or polled by the control module 33.

The sensor system 32 comprises a temperature sensor 321 and/or a humidity sensor 322 configured to measure environmental conditions. The temperature sensor 321 is configured to measure an environmental, i.e. ambient temperature, in particular of the air surrounding the electronic vial cap 1. The humidity sensor 322 is configured to measure the relative humidity of the ambient air. The sensor system 32 is configured to provide (e.g., to transmit) the measured temperature and/or relative humidity to the control module 33 as part of the measurement values.

The humidity sensor 322 is preferably implemented such that it is physically connected to the environment, either by having a direct air contact to measure the humidity of the air, or being separated by a porous membrane. Specifically, the electronic vial cap 1 is configured to have an opening in the housing 1 1 such that the temperature sensor 321 and/or the humidity sensor 322 have direct contact to the ambient air. In an embodiment, the opening is covered by a porous membrane, which may allow for passage of water vapor but repel water droplets.

The sensor system 32 may further comprise additional sensors, in particular an inertial measurement unit (IMU) 323, an electronic tamper detector 324, and/or a fill level detector 325. The IMU 323 is configured to provide motion data indicative of the movement of the electronic cap 1 , the electronic tamper detector 324 is configured to provide tamper data indicative of whether the electronic cap 1 and/or the vial it is attached to has been tampered with, and the fill level detector is configured to measure a weight and/or a fill level of the vial 2 relating to a fill level or weight of the contents of the vial 2. These various measurements and data are provided, by the sensor system 32, as part of the measurement values to the control module 33. The inertial measurement unit (IMII) 323 is configured to measure a motion or movement of the electronic cap, in particular an acceleration in one or more, preferably 3 axes, as well as an angular velocity about one or more, preferably about three axes. Specifically, the IMU 323 may comprise accelerometers and/or gyroscopes. The IMU 323 is configured to provide (e.g., transmit) the motion data to the control module 33.

The electronic tamper detector 324 is configured to detect a tamper attempt. The tamper attempt can include, for example, an attempt to remove the electronic cap from the vial, a removal of the electronic cap from the vial, or an attempt to gain access to the contents of the vial. The electronic tamper detector 324 provides (e.g. transmits) tamper data comprising a tamper status indicator to the control module 33. The tamper status indicator may be implemented, for example, as a defined analog or digital signal.

In an embodiment, the electronic tamper detector 324 comprises a micro switch arranged on the bottom of a base of the housing, which micro switch is engaged when the electronic cap 1 is attached to the vial. The micro switch is arranged and/or configured such that, when the electronic cap 1 is removed from the vial, the micro switch disengages. The electronic tamper detector 324 is configured to monitor the status of the micro switch and to transmit a tamper status indicator indicative of tampering if the micro switch disengages.

In an embodiment, the electronic tamper detector 324 comprises one or more sensing wires, which extend across a defined break-point in the housing 1 1. The break-point in the housing may be implemented as a tamper evident band. The tamper evident band may be implemented in the skirt of the housing, for example along and/or across the one or more latches of the skirt. The break-point is configured such that removal of the electronic cap 1 from the vial after the electronic cap 1 has first been attached to the vial causes the sensing wires to become damaged and/or broken. The electronic tamper detector 324 is configured to perform a tamper measurement on the sensing wires and detect a tamper attempt, for example as a change in resistance and/or capacitance across the sensing wires and the transmit a tamper status indicator indicative of tampering if the tamper measurement satisfies one or more defined criteria indicative of tampering.

The fill level detector 325 may comprise an ultrasonic transducer arranged in the housing and configured to detect the fill level of the vial or vessel, in particular by a vial or vessel filled with a liquid. The ultrasonic transducer is configured to emit an ultrasonic pulse or pulses and to record a return signal, the acoustic return signal generated by reflections of the ultrasonic pulse(s). By analyzing the acoustic return signal, in the fill level detector and/or in the control module, the distance between the ultrasonic transducer and the surface of the contents of the vial or vessel, in particular a liquid surface, is determined. The distance is in particular determined by taking into account the speed of sound through the intervening medium, in particular the air or gas in the top of the vial above the contents, as well as acoustic properties of the vial and/or the electronic cap itself. The fill level may then be determined as a function of the distance, defined dimensions of the vial, and the position of the ultrasonic transducer in the electronic cap.

Figure 16 shows a block diagram illustrating schematically part of the electronic module 3 and the battery 37, in particular showing an embodiment of the electronic module 3 which includes a switch 38. The electronic module 3 in the implementation shown and described with reference to Fig. 16 provides for a very long run time by virtue of a specific configuration designed to minimize power consumption. In particular, a switch 38 is designed to switch the electronic module 3, in particular the control module 33, the wireless radio communications module 34, and/or the sensor system 32, from a relatively low power state (“inactive state”) to a relatively high power state (“active state”). In the inactive state, the power consumption of the electronic module 3 may be close to zero or actually zero, depending on the implementation.

In one embodiment, the switch 38 is arranged between the battery 37 and the control module 33 and/or the wireless radio communications module 34. The switch 38 is designed to interrupt the electrical connection between the battery 37 and the control module 33 and/or the wireless radio communications module 34. In the open state, the switch 38 places the electronic module 3 in the inactive state. In the closed state, the switch 38 places the electronic module 3 in the active state. The switch 38 may be implemented as a distinct and separate electronic component, in particular distinct and separate from the control module 33 and the wireless radio communications module 34, and separate from the battery 37. Thereby, the power consumption of the electronic module 3 in the inactive state is zero and the only power drain of the whole system (electronic vial cap including battery) is due to leakage within the battery itself).

The switch 38 may be configured to open and/or close depending on one or more conditions being met. In particular, the switch 38 may include an integrated real time clock (RTC) configured to open and close the switch according to a defined protocol. The protocol may define a duty cycle in terms of a total length of time of a cycle, an active period, and/or an inactive period. For example, the switch 38 may be configured to close at a defined time-point, remain closed for a defined short duration of between 10 and 100 ms, preferably 20 to 50 ms, and then open for the remainder of a defined duty cycle, which duty cycle may be between 10 seconds and 10 minutes. The corresponding duty factor, i.e. the ratio between the time that the switch is closed vs. the time the switch is open, may therefore be in the range of 1 x 10^-5 to 1 x 10^-3, depending on the implementation.

In an embodiment, the battery 37 may be directly connected to the SiP 35, i.e. without the switch arranged in between. The switch 38 may be an external switch 38, i.e. arranged in a separate component of the electronic module 3, or may be integrated into the control module 33/SiP 35. The switch 38 is designed to switch the control module 33/SiP 35 from an inactive state to an active state. The control module 33/SiP 35 has a significantly higher power consumption in the active state than in the inactive state, e.g., at least a factor of 100 difference, preferably at least a factor of 300. In particular ,the control module 33/SiP 35 may have a current draw of 1000 pA in the active state and less than 300 nA in the inactive state (also referred to as a sleep state).

The table below provides some specific scenarios and examples for an electronic vial cap powered at 2.2 V, with the active period having a length of 26 ms during which time the SiP 35 performs a measurement, records the measurement result in the memory, and transmits the measurement using the wireless radio communications module. The SiP 35 draws a current of approx 1000 pA while active, and 268 nA while inactive.

Figure 17 shows a flow diagram illustrating a method 100 comprising steps S100 to S104. The method 100 is performed by the electronic vial cap (respectively the electronic vial cap). In particular, the method 100 is performed by the electronic module 3, specifically the control module in conjunction with the sensor system and the wireless radio communications module. Not all of the steps are mandatory, in particular some steps may be omitted, depending on the implementation.

The method 100 may be performed upon reception, in the electronic cap, of an appropriate request message, in particular a request message from a reader device. Alternatively or additionally, the method 100 may be initiated by the electronic cap at predetermined time intervals and/or at defined time-points. In particular, the method 100 may be performed upon the electronic module being powered on, electrically connected to the battery, and/or switched from an inactive state to an active state.

In step S100, the measurements are performed using the sensor system. The sensor system, depending on the implementation, will perform one or more measurements using the sensors of the sensor system. The performing of the measurement may be contingent upon a defined criteria being met, in particular that a defined period has elapsed since the last measurement was made and recorded.

The (current) measurement values comprise, for example, a current temperature value, a current relative humidity, movement data, a tamper status indicator, and/or a fill level.

In step S101 , the measurement values are transmitted to the control module, for example in one or more digital messages.

In step S102, the control module receives the current measurement data, for example in the one or more digital messages.

In step S103, the control module records the measurement values in the memory, in particular in the non-volatile memory.

The control module may be configured to determine, using the current measurement values and further measurement values determined at time-points in the past, a maximum temperature and/or a maximum relative humidity level from among the plurality of temperature values and/or the plurality of relative humidity level values.

The (current) measurement values, i.e. those just received from the sensor system, may be stored in the memory along with a time-stamp. This allows for transmission of the measurement values at a later time-point. In other words, the control module may buffer the measurement values by storing them in the memory until they are transmitted using the wireless radio communication module. The measurement values may optionally be deleted subsequent to transmission, or they may be kept in the memory for later retrieval.

The measurement values may optionally be digitally signed to ensure authenticity and immutability of the measurement values. The measurement values may specifically be digitally signed using a cryptographic key stored securely in the control module, in particular in a hardware secure element or otherwise hardened memory with access restrictions.

In step S104, the measurement values are transmitted, by the wireless radio communication module. In particular, the measurement values are transmitted as part of a status message. The status message may include further information, in particular a serial number of the electronic vial cap 1 , an identifier of the vial, information regarding vial contents, and/or a current battery level.

The status message is received by a wireless reader device located within transmission range of the electronic vial cap. The wireless reader device may forward the status message to a server.

The transmission of the status message may be dependent upon the wireless radio communication module receiving, within a defined listening period, a request message from the wireless reader device. In particular, the control module may first being listening for a request message for a defined listening period, the defined listening period having a length of between 10 ms and 50 ms. Preferably, the defined listening period has a duration of between 2x to 3x the duration of a wake frame transmitted by the wireless reader device. The control module is configured such that it will only transmit a response message if the request message in the form of the wake frame is received within the defined listening period.

The control module may be configured to determine, in the wake frame, a serial number, an identifier, and/or some further condition. The control module may be configured to transmit the status message only if the serial number, identifier of the vial and/or the further condition matches the stored in memory serial number of the electronic vial cap, the identifier of the vial, and/or some further condition. The control module may further be configured to transmit the status message only after elapse of a pre-determined randomized period.

The transmission of the status message may enable the wireless receiver to determine a location, in particular a relative spatial location of the electronic vial cap.

The location is determined, for example, using an Angle of Arrival (AoA) of the status message. Specifically, the wireless reader includes a plurality of antenna (at least 3) and a phase difference in the signal carrying the status message is determined between the antennas. This allows for triangulation of the electronic cap to determine the location.

The location may alternatively also be determined using time of flight (ToF), specifically by determining a time-point at which the signal carrying the status message is received at a plurality of antenna, and using trilateration to determine the location.

In an embodiment, the status message is encoded in the packet data unit (PDU) of a Bluetooth Low Energy (BLE) frame. The BLE frame is a broadcast message meaning that any wireless reader device within range configured to receive BLE messages may receive the BLE without a pairing process occurring. This enables wireless reader devices to receive such BLE frames simply and without any initialization or pairing process between the wireless reader and the electronic vial cap. Further, it allows for multiple electronic vial caps to communicate with the wireless reader device simultaneously and easily.

Specifically, the status message comprises a device identifier encoded in the Device Name field of the BLE Advertising Data field, and the measurement values are encoded in the Manufacturer Specific data field of the BLE Advertising Data field.

More specifically, the Raw data sub-field of the Manufacturer Specific data may include the current temperature encoded in two bytes, particularly Bytes 5 and 6, which include the temperature LSB and MSB, respectively, such that a temperature range of -40 to +85 °C are mapped to 12 bits. The Raw data sub-field may further include the current humidity, particular in Byte 7, such that a humidity range of 0 - 100% is mapped to 8 bits. The Raw data sub-field may further include the recorded min and max temperature are encoded in Bytes 9 to 1 1 , Byte 9 encoding Temperature max LSB, Byte 10 encoding Temperature max MSB + Temperature min MSB, and Byte 11 encoding Temperature min LSB, such that the max and min temperatures within the range of -40 to +85 °C are mapped to 12 bits. The Raw data sub-field may further include the recorded humidity max and min are encoded in Bytes 12 and 13, such that the min and max humidity in the range of 0 - 100% are each mapped to 8 bits.

The battery voltage is further included in Byte 8, with VBAT 1 - 4 V mapped to 8 bits. Subsequent to performing one or more of the steps of the method 100, the control module may enter the active state, for example the switch may open, disconnecting the battery, and/or switching the SiP 35 to the inactive state.

The above-described embodiments of the disclosure are exemplary and the person skilled in the art knows that at least some of the components and/or steps described in the embodiments above may be rearranged, omitted, or introduced into other embodiments without deviating from the scope of the present disclosure.

Claims

PATENT CLAIMS

1 . An electronic vial cap (1 ) for attachment onto the top of a vial (2), comprising: a rigid housing (1 1 ) providing an enclosure, the housing (1 1 ) comprising attachment means (12) to releasably attach the electronic vial cap (1 ) to the top of a vial (2); and an electronic module (3) arranged in the housing (1 1 ) comprising: a sensor system (32) configured to measure environmental conditions comprising one or more of: a temperature sensor (321 ) or a humidity sensor (322), a wireless radio communications module (34), and a control module (33) connected to the sensor system (32) and the wireless radio communications module (34), wherein the control module (33) is configured to: record (S103), in a non-volatile memory of the control module (33), measurement values received from the sensor system (32), and transmit (S104), to a wireless reader, using the wireless radio communications module (34), a status message comprising the measurement values.

2. The electronic vial cap (1 ) according to claim 1 , wherein the housing (1 1 ) extends in axial direction (D) and includes: a base (1 11 ), a cylindrical wall (112) extending from the base (11 1 ) axially, and a top cap (123) arranged at a defined distance from the base (11 1 ), thereby forming a substantially cylindrical enclosure (13) inside the housing (1 1 ).

3. The electronic vial cap (1 ) according to one of claims 1 or 2, wherein the electronic vial cap (1 ) further comprises a skirt (14) extending from the housing (1 1 ) in the opposite axial direction, the skirt comprising engagement means (12) for engagement with a vial head (24) of the vial (2).

4. The electronic vial cap (1 ) according to one of claims 1 to 3, wherein the electronic module (3) is arranged on a printed circuit board (31 ) arranged in the housing (11 1 ).

5. The electronic vial cap (1 ) according to claim 4, wherein the housing (11 ) includes one or more supports (31 ) arranged in the enclosure (13) and configured to support the printed circuit board (31 ) at a defined distance from the base (11 1 ).

6. The electronic vial cap (1 ) according to one of claims 4 or 5, wherein the sensor system (32) is arranged, on an upper side of the printed circuit board (31 ) facing in axial direction (D), at a defined location, and the base (1 11 ) comprises a sensor system support (116) extending from the base (1 11 ) to the bottom side of the PCB (31 ) at a location corresponding to the defined location, on the upper side of the PCB (31 ), at which the sensor system (32) is arranged.

7. The electronic vial cap (1 ) according to one of claims 2 to 6, wherein the top cap (113) includes an opening (117) designed to allow ambient air to come into contact with the sensor system (32).

8. The electronic vial cap (1 ) according to claim 7, wherein the opening (1 17) is arranged above the sensor system (32) and the top cap (1 11 ) includes a tubular cylindrical extension (118) around the opening (117), extending from the top cap (11 1 ) towards the sensor system (32).

9. The electronic vial cap (1 ) according to one of claims 1 to 8, wherein the sensor system (32) further comprises a tamper detector (324) configured to detect a removal of the electronic vial cap (1 ) from the vial (2).

10. The electronic vial cap (1 ) according to one of claims 1 to 8, wherein the electronic module (3) further comprises a fill level detector (325) configured to determine a weight and/or a fill level of the vial (2).

1 1. The electronic vial cap according to one of claims 1 to 10, wherein the sensor system (32) further comprises an inertial measurement unit (323) and the control module (33) is further configured to: receive, from the inertial measurement unit (323), motion data; determine, using the motion data, whether the electronic vial cap (1 ) is in motion, in particular by comparing the motion data with one or more defined motion thresholds; and switch, from a first mode to a second mode, if the electronic vial cap (1 ) is in motion, wherein the control module (33) is configured to transmit the status message with a defined first periodicity in the first mode and a defined second periodicity in the second mode, which first periodicity and second periodicity are different.

12. The electronic vial cap (1 ) according to one of claims 1 to 11 , further comprising a battery compartment (36) configured to receive a battery.

13. The electronic vial cap (1 ) according to one of claims 1 to 12, wherein the wireless radio communications module (34) and the control module (33) are implemented in a single system in a package (35), enclosed in a single chip carrier package.

14. The electronic vial cap (1 ) according to one of claims 1 to 13, wherein the control module (33) is further configured to determine, using the measurement values, a maximum and/or a minimum value of one or more of: the recorded temperature and/or the recorded humidity, and wherein the control module (33) is further configured to transmit the status message including the maximum and/or the minimum value(s).

15. The electronic vial cap (1 ) according to one of claims 1 to 14, wherein the wireless radio communications module (34) is configured to implement a Bluetooth protocol.

16. The electronic vial cap (1 ) according to claim 15, wherein the control module (3) is configured to transmit, using the wireless radio communications module (34), the status message in a Bluetooth Low Energy frame.

17. The electronic vial cap (1 ) according to one of claims 1 to 16, wherein the engagement means (12) of the skirt (14) comprise a plurality of latches (121 ) arranged circumferentially around the skirt (14) for engagement with the vial (2).

18. The electronic vial cap (1 ) according to one of claims 1 to 17, wherein the engagement means (12) of the skirt (14) comprise a screw thread for engagement with a screw thread of the vial head (24) of the vial (2).

19. The electronic vial cap (1 ) according to one of claims 1 to 18, further comprising a stopper (25) arranged at least partially inside the skirt (14) configured to engage against the vial head (24) of the vial (2) for sealing the vial.

20. The electronic vial cap (1 ) according to claim 19, further comprising a vial cap (26) arranged inside the stopper (25) configured to engage with the vial head (24) of the vial (2).

21 . A vial (2) having fitted thereon an electronic vial cap (1 ) according to one of claims 1 to 20.