Data collection device for attachment to an injection device

A data collection device for attachment to an injection device, such as an injector pen, includes a sensor arrangement to detect movement of a movable component of the injection device relative to the data collection device during delivery of a medicament by the injection device, and a processor arrangement configured to, based on said detected movement, determine a medicament dosage administered by the injection device. The processor arrangement may monitor the time that has elapsed since the medicament dosage was administered, and control a display to show the mediacament dosage and elapsed time to provide a memory aid to the user. In an example embodiment, the sensor arrangement includes an optical encoder and the movable component includes a plurality of light barrier formations. The movable component may be a number sleeve that provides a visual indication of a dose programmed into the injection device.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is the national stage entry of International Patent Application No. PCT/EP2016/052987, filed on Feb. 12, 2016, and claims priority to Application No. EP 15155758.4, filed in on Feb. 19, 2015, the disclosures of which are expressly incorporated herein in entirety by reference thereto.

TECHNICAL FIELD

The present disclosure relates to a data collection device for attachment to an injection device and collecting medicament dosage information therefrom.

BACKGROUND

A variety of diseases exists that require regular treatment by injection of a medicament. Such injection can be performed by using injection devices, which are applied either by medical personnel or by patients themselves. As an example, type-1 and type-2 diabetes can be treated by patients themselves by injection of insulin doses, for example once or several times per day. For instance, a pre-filled disposable insulin pen can be used as an injection device. Alternatively, a re-usable pen may be used. A re-usable pen allows replacement of an empty medicament cartridge by a new one. Either pen may come with a set of one-way needles that are replaced before each use. The insulin dose to be injected can then for instance be manually selected at the insulin pen by turning a dosage knob and observing the actual dose from a dose window or display of the insulin pen. The dose is then injected by inserting the needle into a suited skin portion and pressing an injection button of the insulin pen. To be able to monitor insulin injection, for instance to prevent false handling of the insulin pen or to keep track of the doses already applied, it is desirable to measure information related to a condition and/or use of the injection device, such as for instance information on the injected insulin dose.

SUMMARY

According to one aspect, a data collection device includes a mating arrangement configured for attachment to an injection device, a sensor arrangement configured to detect movement of a movable dosage programming component of the injection device relative to the data collection device during delivery of a medicament, and a processor arrangement configured to, based on said detected movement, determine a medicament dosage administered by the injection device.

In this manner, the data collection device can collect medicament dosage information without relying on additional actions being made by a user and may improve the reliability of the recordal and logging of medicament administrations. In addition, the display of a previous dosage may act as a memory aid to the user when programming a subsequent dosage into the injector pen.

The sensor arrangement may include one or more of an optical sensor, a magnetic sensor, a capacitive sensor and a mechanical sensor. For example, the sensor arrangement may include an optical encoder unit. the processor arrangement may be configured to monitor a time period elapsed since a pulse was output by the optical encoder and to determine said medicament dosage if said time period exceeds a predetermined threshold. This may allow the end point of an injection stroke to be reliably identified. Alternatively, or additionally, the sensor arrangement may include mechanical switches and/or tracks for detecting the relative movement.

The processor arrangement may be configured to obtain time stamp information for the detected administration of the medicament dosage and to store the determined medicament dosage and said time stamp information, for example, to provide a log of administered injections. In this case, the data collection device may, optionally, include an output interface to allow the stored medicament dosage and time stamp information to be transmitted to an external device, such as a computer, through a communications link. The output interface may be configured for communications with the external device via a wired or wireless link.

Additionally, or alternatively, the processor arrangement may be configured to monitor an elapsed time after the detected administration, and to control a display to show the determined medicament dose and the elapsed time. By displaying such information, the data collection device may provide a further memory aid to the user.

In any of the above described arrangements according to this aspect, the data collection device may be attachable to a dosage programming component of the injection device, which is movable by a user to program a medicament dosage to be administered, so that the data collection device moves with the dosage programming component. In such an embodiment, the data collection device may be configured to allow the user to program the medicament dosage into the injector pen by gripping and moving the data collection device, instead of gripping and moving the dosage programming component. To facilitate such programming, the data collection device may be configured to provide a larger contact surface for the user's grip, when compared with the dosage programming component, or may include other formations that may allow a user to program the medicament dosage more easily. This may be particularly useful in instances where the user has limited dexterity.

In some embodiments, the data collection device is releasably attachable to the injection device. In other embodiments, the data collection device is permanently attachable to the injection device.

This aspect also provides a medicament administration apparatus comprising said data collection device and an injection device. An example of such a medicament administration apparatus may include an injection device comprising a movable dosage programming component, wherein the movable dosage programming component is configured to move as a medicament dosage is programmed into the injection device and a data collection device comprising an optical sensor, wherein the movable dosage programming component includes a plurality of light barriers.

The medicament administration apparatus may be configured so that the movable dosage programming component does not move relative to the data collection device during programming of a dose into the injection device. Such an arrangement may limit the relative movement to the period during delivery of a medicament so that it is not necessary for the processor arrangement to determine whether a dosage programmed into the injection device is increasing, e.g. during dosage programming, or decreasing, e.g. during dosage programming or during medicament delivery. In an embodiment where it is not necessary to discriminate between increasing and decreasing dosage levels, multiple sensors are not required. Hence, the sensor arrangement may be configured with a single sensor. This can provide a relatively simple apparatus and reduced data processing requirements when compared with sensor arrangements having multiple sensors.

The injection device and the data collection device may include formations that co-operate to attach the data collection device to the injection device. In some embodiments, one of a projection and a recess may be provided on the injection device and the other of the projection and the recess provided in the mating arrangement data collection device, for example, to provide a clip attachment or a snap-fit attachment.

In some embodiments, the injection device is a disposable injection device and the data collection device is configured to be releasably attachable to the injection device. In other embodiments, the injection device is a reusable injection device and the data collection device is permanently attached to the injection pen.

The injection device may be an injector pen.

DETAILED DESCRIPTION

In the following, embodiments of the present disclosure will be described with reference to an insulin injection device. The present disclosure is however not limited to such application and may equally well be deployed with injection devices that eject other medicaments.

FIG. 1is an exploded view of a medicament delivery device. In this example, the medicament delivery device is an injection device1, such as Sanofi's SoloSTAR® insulin injection pen.

The injection device1ofFIG. 1is a pre-filled, disposable injection pen that includes a housing10and contains an insulin container14, to which a needle15can be affixed. The needle is protected by an inner needle cap16and either an outer needle cap17other cap18. An insulin dose to be ejected from injection device1can be programmed, or ‘dialed in’ by turning a dosage knob12, and a currently programmed dose is then displayed via dosage window13, for instance in multiples of units. For example, where the injection device1is configured to administer human insulin, the dosage may be displayed in so-called International Units (IU), wherein one IU is the biological equivalent of about 45.5 micrograms of pure crystalline insulin ( 1/22 mg). Other units may be employed in injection devices for delivering analogue insulin or other medicaments. It should be noted that the selected dose may equally well be displayed differently than as shown in the dosage window13inFIG. 1.

The dosage window13may be in the form of an aperture in the housing10, which permits a user to view a limited portion of a number sleeve70that is configured to move when the dosage knob12is turned, to provide a visual indication of a currently programmed dose. The dosage knob12is rotated on a helical path with respect to the housing10when turned during programming.

In this example, the dosage knob12includes one or more formations71a,71b,71cto facilitate attachment of a data collection device to be described herein below.

The injection device1may be configured so that turning the dosage knob12causes a mechanical click sound to provide acoustical feedback to a user. The number sleeve70mechanically interacts with a piston in insulin container14. When needle15is stuck into a skin portion of a patient, and then injection button11is pushed, the insulin dose displayed in display window13will be ejected from injection device1. When the needle15of injection device1remains for a certain time in the skin portion after the injection button11is pushed, a high percentage of the dose is actually injected into the patient's body. Ejection of the insulin dose may also cause a mechanical click sound, which is however different from the sounds produced when using dosage knob12.

In this embodiment, during delivery of the insulin dose, the dosage knob12is turned to its initial position in an axial movement, that is to say without rotation, while the number sleeve70is rotated to return to its initial position, e.g. to display a dose of zero units.

Injection device1may be used for several injection processes until either the insulin container14is empty or the expiration date of the medicament in the injection device1(e.g. 28 days after the first use) is reached.

Furthermore, before using injection device1for the first time, it may be necessary to perform a so-called “prime shot” to remove air from insulin container14and needle15, for instance by selecting two units of insulin and pressing injection button11while holding injection device1with the needle15upwards. For simplicity of presentation, in the following, it will be assumed that the ejected amounts substantially correspond to the injected doses, so that, for instance the amount of medicament ejected from the injection device1is equal to the dose received by the user. Nevertheless, differences (e.g. losses) between the ejected amounts and the injected doses may need to be taken into account.

FIG. 2is a perspective view of one end of the injection device1when a data collection device20according to an example embodiment is attached. The data collection device20includes a housing21and a display22for presenting dosage information22a.

As shown inFIG. 3, the data collection device20also includes a processor arrangement23including one or more processors, such as a microprocessor, a Digital Signal Processor (DSP), Application Specific Integrated Circuit (ASIC), Field Programmable Gate Array (FPGA) or the like, together with memory units24,25, including program memory24and main memory25, which can store software for execution by the processor arrangement23.

A sensor arrangement26, comprising one or more sensors, is provided. In this particular example, the sensor arrangement26is an optical encoder, including a light source26a, such as a light emitting diode (LED) and a light detector26b, such as an optical transducer.

An output27is provided, which may be a wireless communications interface for communicating with another device via a wireless network such as wi-fi or Bluetooth®, or an interface for a wired communications link, such as a socket for receiving a Universal Series Bus (USB), mini-USB or micro-USB connector.

A power switch28is provided, together with a battery29. In one example, the power switch28is configured to respond to pressure applied to the display22by powering the data collection device20on or off.

FIG. 4shows the injection button11and dosage knob12of the injection device1in more detail. In this particular embodiment, the injection button11includes a cavity30on its upper surface, configured to receive at least a portion of the data collection device20. In this example, a sidewall of the cavity30includes an aperture31, through which a portion of the number sleeve70may be viewable.

FIG. 5depicts the number sleeve70. In this particular embodiment, castellations72are moulded onto one end of the number sleeve70. One end of the number sleeve70is provided with castellations72that may act as light barriers for light emitted by the light source26a.

In the particular example shown inFIG. 5, twelve castellations72are provided. The twelve castellations and the gaps between them have widths selected to provide24“edges”, to correspond to dose increments up to a maximum dose24units shown on the number sleeve70. The castellations72are formed using a material that has a reflectivity that differs from that of an inner surface of the injection button11.

The number sleeve70is arranged to rotate helically along one direction as a dose is programmed into the injection device1using the dosage knob12and also to rotate helically in an opposite direction during delivery of a medicament dose by the injection device1.

FIG. 6is a cross-sectional view of part of the data collection device20and the injection device1.

As shown inFIG. 6, the dosage knob12and the housing21of the data collection device20include co-operating formations71a,73a. In this particular embodiment, these formations are in the form of a projection73aprovided in the housing21of the data collection device20and a detent71aprovided in the dosage knob12. As shown inFIG. 1, the formations71a,71b,71chave only a limited extent, so that the data collection device20cannot rotate relative to the dosage knob12when attached.

Since the data collection device20and dosage knob12cannot rotate relative to one another, they move in concert as a dosage is programmed into the injection device1. This may allow provision of a more ergonomic arrangement, since the data collection device20may provide a larger surface that can be gripped and rotated by the user during dosage programming. Alternatively, the data collection device20may be provided with formations on its outer surface to facilitate rotation of the data collection device20and, therefore, the dosage knob12.

In arrangements where the data collection device20is to be releasably attachable to the injection device1, the co-operating formations71a,73amay provide a clip-type arrangement that allows for easy removal of the data collection device20. Such an arrangement may be useful where the data collection device20is to be used with disposable injection devices1, since it allows the data collection device20to be removed from an injection device1and reused, or to allow a user with greater flexibility by being about to attach and remove the data collection device20at will.

Alternatively, the co-operating formations71a,73amay be configured to attach the data collection device20to the injection device1permanently, for example, using a “snap-fit”. In other embodiments, the data collection device20maybe permanently attached in other ways, for example, through bonding. Such permanent attachments may be useful where the injection device1is reusable.

The number and/or positions of the co-operating formations71a,73amay be configured so that the data collection device20can only be attached to the injection device1in one particular position. In this particular example, the housing21of the data collection device20includes an aperture74through which light emitted by the light source26aand light detected by the light detector26bcan pass when the data collection device20is in position. The co-operating formations71a,73amay be arranged so that, when the data collection device20is attached to the injection device1, the aperture74in the housing21of the data collection device20is aligned with the aperture31in the sidewall of the cavity30in the injection button11, as shown inFIG. 6.

As shown by the arrow75inFIG. 6, light emitted by the light source26athus passes through the apertures74,31and into the injection button11. If a castellation72of the number sleeve70is viewable through the aperture31, then the light will be reflected from the castellation72, and back through the apertures31,74, where it can be detected by the light detector26b. Since the reflectivity of the castellations72differs from that of the inner surface of the injection button11, the amount of light detected by the light detector26bwill depend on how much of a castellation72can be viewed through the aperture31. In certain embodiments, the sensor arrangement26may be arranged to emit and/or detect only light with particular polarisation characteristics, in order to mitigate effects of stray light entering the aperture74.

FIG. 7is a graph showing changes in the intensity of light received by the light detector26bduring programming and delivery of a medicament dose, whileFIG. 8is a graph showing an output that may be generated by the sensor arrangement26of this embodiment.

As noted above, while a dose is being programmed into the injection device1, during time period t1inFIGS. 7 and 8, the dosage knob12and the number sleeve70rotate helically. In this particular embodiment, since the data collection device20moves in concert with the dosage knob12, the amount of light reflected back towards the light detector26bshould remain substantially constant, since there is little or no relative rotational movement between the number sleeve70and the data collection device20. The amount of reflected light should also remain substantially constant between the completion of dosage programming and the start of the injection, shown as time period t2inFIG. 7, since the number sleeve70, dosage knob12and data collection device20are not being moved by a user.

The output of the sensor arrangement26, shown inFIG. 8, is therefore substantially constant during time periods t1and t2. The actual level of the output during time periods t1and t2will depend on whether a castellation72is viewable through the aperture31and, if so, how much of the aperture is covered by the castellation72.

During the delivery of the medicament, shown as time period t3inFIGS. 7 and 8, the number sleeve70rotates helically but the dosage knob12moves only axially, without rotating. Hence, the number sleeve70is rotating relative to the data collection device20.

During time period t3, the castellations72of the number sleeve70will move across the aperture31as the number sleeve31rotates relative to the dosage knob12and data collection device20, and the intensity of light received by the light detector26bwill vary accordingly, as shown inFIG. 7. In this particular example, the number sleeve70is more reflective than the inner surface of the injection button11, and so the highest intensity levels shown inFIG. 7correspond to positions where the amount by which the castellation72covers the aperture31is at its greatest.

The output of the light detector26bduring time period t3will switch between a high and a low level, based on the received light intensity, as shown inFIG. 8. Since the edges of the castellations72correspond to increments in the medicament dosage, the processor arrangement23can determine an amount of medication delivered by the injection device based on the number of transitions between the high level and the low level in the output of the sensor arrangement26.

The length of time period t3will depend on the administered dosage and also on when the medicament delivery is deemed to be complete. When the medicament delivery is complete, the number sleeve70will cease to rotate relative to the dosage knob12and the data collection device20, and the signal from the sensor arrangement26will stay at a substantially constant level.

In some embodiments, the processor arrangement23is arranged to monitor the time period that has elapsed from the last transition or the last pulse in the output of the sensor arrangement24. When the elapsed time period reaches a predetermined threshold t4, the medicament delivery is considered to have been completed and the processor arrangement23proceeds with determining the medicament dose delivered to the user, based on the number of detected transitions in the output of the sensor arrangement during time period t3. In the particular example shown inFIGS. 7 and 8, there are eight transitions. Since the transitions correspond to the edges of the castellations which, in turn, correspond to the dosage increments in this particular embodiment, the determined medicament dose is 8 units.

The processor arrangement23then stores the determined medicament dose in main memory24. The processor arrangement23may also store time stamp information, to provide a log recording delivery of medicament to the user.

The processor arrangement23may then power down the data collection device20, in order to conserve battery power.

When the data collection device20is powered on again, by a user activating the power switch28, the processor arrangement23may control the display to show the determined medicament dose information22a, to aid the memory of the user. Optionally, the processor arrangement23may monitor an elapsed time since the determined medicament dose was delivered and control the display to show that elapsed time information too. For example, the processor arrangement23may cause the display22to switch periodically between displaying the determined medicament dosage information22aand the elapsed time.

The processor arrangement23may also transmit the determined medicament dosage and, where determined, the time stamp information to another device, such as a computer40, as shown inFIG. 9. As noted above, the output27may be configured to transmit the information using a wireless communications link. Alternatively, the data collection device20may be connected to the computer40using a wired connection41to allow the information to be uploaded to the computer40. The processor arrangement23may be configured to transmit the information to the computer40periodically.

The specific embodiments described in detail above are intended merely as examples of how the present disclosure may be implemented. Many variations in the configuration of the data collection device20and/or the injection device1may be conceived.

For example, it is not necessary that the formations provided on the number sleeve are in the form of castellations, nor is it necessary for the widths of the castellations and the gaps between them to correspond precisely to individual dosage increments, as in the above embodiment.

While the above described embodiment utilises an optical sensing arrangement26, other types of sensors may be used as well as, or instead of, optical sensors. For example, the sensing arrangement may include a magnetic sensor, such as a Hall effect sensor. In such an example, one or more magnets may be mounted on the number sleeve, so that rotation of the number sleeve relative to the data collection device results in a varying magnetic field. In another example, a capacitive sensor may be used, where elements provided on the number sleeve may affect the capacitance between two plates provided in the data collection device. In other examples, mechanical sensors, with mechanical switches and/or tracks, may be used to detect the relative movement.

While the embodiment shown inFIG. 3includes only one sensor, other embodiments may be devised in which the sensor arrangement includes multiple sensors of one or more types.

In the above described embodiments, the injection button11included a central cavity30for receiving at least part of the data collection device20. in other embodiments, the central cavity may be omitted from the injection button if the data collection device20does not require one.

While the arrangement shown inFIG. 6included co-operating formations in the form of a detent71ain the dosage knob12and a projection73ain the housing21of the data collection device20, other types of co-operating formations or attachment methods may be used.

While the embodiments above have been described in relation to collecting data from an insulin injector pen, it is noted that embodiments of the disclosure may be used for other purposes, such as monitoring of injections of other medicaments.