Data collection device for attachment to injection device

Abstract

To provide a data collection device that is attached to an injection device and collects medicament dosage information from it.SOLUTION: A data collection device for attachment to an injection device (1), such as an injector pen, comprises: a sensor arrangement to detect movement of a movable component (70) 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 medicament 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 comprises a plurality of light barrier formations.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a data collection device that is attached to an injection device and collects drug dosage information therefrom. [Background technology]

[0002] Various diseases require regular treatment by injection of medication. Such injections can be performed using an injection device and applied by a medical professional or the patient himself. As an example, type 1 and type 2 diabetes can be treated by the patient himself, for example by injection of one or several insulin doses per day. For example, a pre-filled disposable insulin pen can be used as the injection device. Alternatively, a reusable pen can be used. The reusable pen can replace the empty medication cartridge with a new one. Both pens can be equipped with a set of single-use needles that are replaced before each use. The insulin dose to be injected can then be manually selected in the insulin pen, for example by turning the dosage knob and observing the actual dose from the dose window or display of the insulin pen. The needle is then inserted into the appropriate skin area and the dose is injected by pressing the injection button of the insulin pen. It is desirable to measure information about the status and / or use of the injection device, for example information about the insulin dose already injected, so that the insulin injection can be monitored, for example to prevent mishandling of the insulin pen or to keep track of doses already applied. Summary of the Invention [Means for solving the problem]

[0003] According to one aspect, the data collection device includes a mating apparatus configured to be attached to the injection device, a sensor apparatus configured to detect movement of a movable dosage program component of the injection device relative to the data collection device during delivery of the medication, and a processor apparatus configured to determine a medication dosage administered by the injection device based on the detected movement.

[0004] In this manner, the data collection device can collect medication dosage information without relying on additional actions taken by the user, improving the reliability of recording and logging of medication administration. Additionally, displaying the previous dose can act as a memory aid for the user when programming the next dose into the injection pen.

[0005] The sensor device may include one or more of an optical sensor, a magnetic sensor, a capacitive sensor, and a mechanical sensor. For example, the sensor device may include an optical encoder device. The processor device is configured to monitor the time period that has elapsed since a pulse was output by the optical encoder and determine the drug dosage if the time period exceeds a predetermined threshold. This may allow for reliable identification of an end point of an injection stroke. Alternatively, or in addition, the sensor device may include a mechanical switch and / or track to detect relative motion.

[0006] The processor unit is configured to obtain time stamp information for the detected administration of the drug dosage and store the determined drug dosage and said time stamp information, e.g., to provide a log of administered injections. In this case, the data collection device may also optionally include an output interface that allows the stored drug dosage and time stamp information to be transmitted to an external device, such as a computer, via a communication link. The output interface may communicate with the external device via a wired or wireless link. The device is configured to communicate with the

[0007] Additionally or alternatively, the processor unit is configured to monitor the elapsed time after administration detection and control the display to display the determined drug dosage and the elapsed time. By displaying such information, the data collection device can provide an additional memory aid for the user.

[0008] In any of the apparatus according to this aspect described above, the data collection device may be attachable to a dosage program component of the injection device that is moved by the user for programming the drug dosage to be administered, so as to move with the dosage program component. In one such embodiment, the data collection device is configured such that the user can program the drug dosage into the injection pen by gripping and moving the data collection device, rather than gripping and moving the dosage program component. To facilitate such programming, the data collection device may be configured to provide a larger contact surface for the user to grip, as compared to the dosage program component, or may include other structure that can enable the user to more easily program the drug dosage. This is particularly useful where the user has limited dexterity.

[0009] In some embodiments, the data collection device is releasably attachable to the injection device, hi other embodiments, the data collection device is permanently attachable to the injection device.

[0010] This aspect further provides a drug administration apparatus comprising said data collection device and an injection device. An example of such a drug administration apparatus may include an injection device comprising a movable dosage program component configured to move when a drug dosage is programmed into the injection device, and a data collection device comprising an optical sensor, where the movable dosage program component comprises a plurality of light barriers.

[0011] The drug delivery device is configured such that the movable dosage program component does not move relative to the data collection device while programming the dose into the injection device. Such an arrangement can limit the relative motion to the delivery period of the drug, and thus eliminate the need for the processor device to determine whether the dosage programmed into the injection device is increasing, for example, during dosage programming, or decreasing, for example, during dosage programming or drug delivery. In an embodiment where it is not necessary to distinguish between increasing dosage levels and decreasing dosage levels, multiple sensors are not required. Thus, the sensor device can be configured with a single sensor, which makes the device relatively simple and reduces data processing requirements when compared to a sensor device having multiple sensors.

[0012] The injection device and the data collection device may include cooperating structures to attach the data collection device to the injection device, in some embodiments, one of a protrusion and a recess is provided on the injection device and the other of the protrusion and the recess is provided on a mating arrangement of the data collection device, for example to provide a clip or snap-fit ​​attachment.

[0013] 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, hi other embodiments, the injection device is a reusable injection device and the data collection device is permanently attached to the injection pen.

[0014] The injection device may be an injection pen.

[0015] Exemplary embodiments of the present invention will now be described with reference to the accompanying drawings. [Brief description of the drawings]

[0016] [Figure 1]FIG. 2 is an exploded view of an injection device for use with a data collection device according to an embodiment of the present invention. [Diagram 2] FIG. 2 is a diagram of a data collection device according to one embodiment attached to the injection device of FIG. 1. [Diagram 3] FIG. 3 is a block diagram of the data collection device shown in FIG. 2. [Figure 4] FIG. 2 is a partial perspective view of the injection device of FIG. 1. [Diagram 5] FIG. 2 is a perspective view of a movable dosage program component of the injection device of FIG. 1. [Figure 6] 4 is a partial cross-sectional view of the data collection device of FIG. 3 and the injection device of FIG. 1 when attached together. [Figure 7] 4 is a graph of the light intensity received by a sensor arrangement of the data collection device of FIG. 3; [Figure 8] 8 is a graph of the output of the sensor device based on received light intensity shown in FIG. 7. [Figure 9] FIG. 4 is a diagram of a system in which data from the data collection device of FIG. 3 is transmitted to other devices. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] In the following, embodiments of the invention are described with reference to an insulin injection device, however the invention is not limited to such application and can be used equally well with injection devices releasing other medicaments.

[0018] Figure 1 shows an exploded view of a drug delivery device, in this example an injection device 1 such as the Sanofi SoloSTAR® insulin injection pen.

[0019] The injection device 1 of FIG. 1 is a pre-filled, disposable injection pen, including a housing 10, containing an insulin container 14 to which a needle 15 is attached. The needle is protected by an inner needle cap 16 and an outer needle cap 17 or other cap 18. The insulin dose to be released from the injection device 1 can be programmed or "dialed" by turning the dosage knob 12. The currently programmed dose is then displayed via the dosage window 13, for example in multiples of units. For example, if the injection device 1 is configured to administer human insulin, the dosage is displayed in so-called international units (IU), where 1 IU is approximately 45.5 micrograms of biological equivalent pure crystalline insulin (1 / 22 mg). Other units may be used in injection devices that deliver insulin analogues or other drugs. It should be noted that the selected dose can be displayed well differently than that shown in the dosage window 13 of FIG. 1.

[0020] The dosage window 13 may be in the form of an aperture in the housing 10. The dosage window 13 allows the user to view a limited portion of the number sleeve 70 that is configured to move as the dosage knob 12 is turned, thus providing a visual indication of the currently programmed dose. The dosage knob 12 rotates on a helical path relative to the housing 10 as it is turned during programming.

[0021] In this example, dosage knob 12 includes one or more structures 71a, 71b, 71c that facilitate attachment of a data collection device as described herein below.

[0022] The injection device 1 is configured such that turning the dose knob 12 produces a mechanical click sound, providing acoustic feedback to the user. The number sleeve 70 mechanically interacts with a piston in the insulin container 14. Inserting the needle 15 into the patient's skin area and pressing the injection button 11 will cause the insulin dose displayed in the display window 13 to be released from the injection device 1. The majority of the dose is actually injected into the patient's body when the needle 15 of the injection device 1 remains in the skin area for a period of time after the injection button 11 is pressed. Release of the insulin dose also produces a mechanical click sound. However, the click sound is different from the sound produced when the dosage knob 12 is used.

[0023] In this embodiment, during delivery of an insulin dose, the dosage knob 12 moves back toward its initial position with an axial movement, i.e., without rotation, while the number sleeve 70 rotates back to its initial position, e.g., to display a dose of zero units.

[0024] The injection device 1 can be used for several injection treatments until the insulin container 14 is empty or the expiry date of the drug in the injection device 1 is reached (eg 28 days from first use).

[0025] Furthermore, before using the injection device 1 for the first time, it may be necessary to perform a so-called "prime shot" by selecting, for example, 2 units of insulin and removing air from the insulin container 14 and the needle 15 by pressing the injection button 11 while holding the injection device 1 with the needle 15 facing upwards. For simplicity of presentation, it is assumed below that the discharged amount substantially corresponds to the injected dose, and thus, for example, that the amount of drug discharged from the injection device 1 is equal to the dose received by the user. Nevertheless, it may also be necessary to take into account differences (e.g. losses) between the discharged amount and the injected dose.

[0026] 2 is a perspective view of one end of the injection device 1 when a data collection device 20 is attached according to an exemplary embodiment. The data collection device 20 includes a housing 21 and a display 22 that shows dosage information 22a.

[0027] As shown in FIG. 3, the data collection device 20 further includes a processor unit 23 including one or more processors such as a microprocessor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), etc., together with memory units 24, 25 including a program memory 25 and a main memory 24 capable of storing software executed by the processor unit 23.

[0028] A sensor arrangement 26 is provided that includes one or more sensors. In this particular example, the sensor arrangement 26 is an optical encoder that includes a light source 26a, such as a light emitting diode (LED), and a light detector 26b, such as an optical transducer.

[0029] An output device 27 is provided which may be a wireless communication interface for communicating with other devices via a wireless network such as wi-fi or Bluetooth, or an interface for a wired communication link such as a socket receiving a Universal Serial Bus (USB), mini USB or micro USB connector.

[0030] A power switch 28 is provided along with a battery 29. In one embodiment, the power switch 28 is configured to respond to pressure applied to the display 22 by powering the data collection device 20 on or off.

[0031] 4 shows in more detail the injection button 11 and dosage knob 12 of the injection device 1. In this particular embodiment, the injection button 11 includes a cavity 30 on its upper side that is configured to receive at least a portion of the data collection device 20. In this example, a side wall of the cavity 30 includes an aperture 31 through which a portion of the digit sleeve 70 is visible.

[0032] 5 shows a number sleeve 70. In this particular embodiment, castellations 72 are molded into one end of the number sleeve 70. One end of the number sleeve 70 is provided with castellations 72 that can act as a light barrier to the light emitted by the light source 26a.

[0033] In the particular example shown in Figure 5, there are provided twelve castellations 72. The twelve castellations and the gaps between them have widths selected to provide twenty-four "edges" to accommodate up to twenty-four dose increments, the maximum dose indicated on the numeric sleeve 70. The castellations 72 are formed using a material having a different reflectivity than the inner surface of the injection button 11.

[0034] The number sleeve 70 is arranged to rotate spirally along one direction when a dose is programmed into the injection device 1 using the dosage knob 12, and to rotate spirally in the opposite direction during delivery of a drug dose by the injection device 1.

[0035] FIG. 6 is a partial cross-sectional view of the data collection device 20 and the injection device 1.

[0036] As shown in Figure 6, the dosage knob 12 and the housing 21 of the data collection device 20 include cooperating structures 71a, 73a. In this particular embodiment, these structures are in the form of a protrusion 73a on the housing 21 of the data collection device 20 and a detent 71a on the dosage knob 12. As shown in Figure 1, the structures 71a, 71b, 71c have only a limited range, so that the data collection device 20 cannot rotate relative to the dosage knob 12 when attached thereto.

[0037] The data collection device 20 and the dosage knob 12 cannot rotate relative to each other and therefore move together when a dosage is programmed into the injection device 1. This may provide a more ergonomic device because the data collection device 20 may provide a larger surface for the user to grasp and rotate while programming the dosage. Alternatively, the data collection device 20 may be provided with structure on its outer surface that facilitates rotation of the data collection device 20, and thus the dosage knob 12.

[0038] In an arrangement in which the data collection device 20 is releasably attached to the injection device 1, the cooperating structures 71a, 73a may provide a clip-type arrangement that allows easy removal of the data collection device 20. Such an arrangement may be useful when the data collection device 20 is used with a disposable injection device 1, as it allows the data collection device 20 to be removed from the injection device 1 and reused, or allows greater flexibility for the user in attaching and removing the data collection device 20 at will.

[0039] Alternatively, the cooperating structures 71a, 73a may be configured such that the data collection device 20 is permanently attached to the injection device 1, for example using a "snap fit". In other embodiments, the data collection device 20 is permanently attached in other ways, for example by gluing. Such a permanent attachment is useful if the injection device 1 is reusable.

[0040] The number and / or location of the cooperating structures 71a, 73a are configured such that the data collection device 20 is attached to the injection device 1 only in one particular position. In this particular example, the housing 21 of the data collection device 20 includes an aperture 74 through which light emitted by the light source 26a and detected by the light detector 26b can pass when the data collection device 20 is in position. The cooperating structures 71a, 73a are positioned such that when the data collection device 20 is attached to the injection device 1, the aperture 74 in the housing 21 of the data collection device 20 is aligned with the aperture 31 in the side wall of the cavity 30 of the injection button 11, as shown in FIG. 6.

[0041] As shown by arrow 75 in FIG. 6, light emitted by light source 26a thus passes through apertures 74, 31 and into injection button 11. If castellations 72 of number sleeve 70 are visible through aperture 31, light will be reflected from castellations 72 and return through apertures 31, 74 and can be detected by photodetector 26b. Because the reflectivity of castellations 72 differs from the reflectivity of the inner surface of injection button 11, the amount of light detected by photodetector 26b will depend on how much of castellations 72 are visible through aperture 31. In some embodiments, sensor device 26 is arranged to emit and / or detect only light having specific polarization characteristics to mitigate the effects of stray light entering aperture 74.

[0042] Figure 7 is a graph showing the change in light intensity received by photodetector 26b during programming and delivery of a drug dose, and Figure 8 is a graph showing the output produced by sensor device 26 of this embodiment.

[0043] As mentioned above, during the period t1 in Figs. 7 and 8 while the dose is programmed into the injection device 1, the dosage knob 12 and the number sleeve 70 rotate in a spiral manner. In this particular embodiment, the data collection device 20 moves together with the dosage knob 12, so the amount of light reflected back to the photodetector 26b should remain substantially constant because there is little or no relative rotational movement between the number sleeve 70 and the data collection device 20. Between the completion of the dosage programming and the start of the injection, shown as period t2 in Fig. 7, the number sleeve 70, the dosage knob 12 and the data collection device 20 are not moved by the user, so the amount of light reflected should also remain substantially constant.

[0044] 8, the output of sensor device 26 is substantially constant during periods t1 and t2. The actual output level during periods t1 and t2 will depend on whether castellations 72 are visible through aperture 31 and, if so, the extent to which the aperture is covered by castellations 72.

[0045] During delivery of the medication, shown as period t3 in Figures 7 and 8, the digit sleeve 70 rotates helically while the dosage knob 12 does not rotate but only moves axially. Thus, the digit sleeve 70 rotates relative to the data collection device 20.

[0046] During time period t3, the castellations 72 of the number sleeve 70 move across the aperture 31 as the number sleeve 70 rotates relative to the dosage knob 12 and data collection device 20, causing the intensity of light received by the photodetector 26b to change accordingly, as shown in Figure 7. In this particular example, the number sleeve 70 is more reflective than the inner surface of the injection button 11, so the highest light intensity level shown in Figure 7 is due to the castellations 72 corresponds to the position where the amount of coverage of the aperture 31 is at its maximum.

[0047] The output of the photodetector 26b during time period t3 will switch between high and low levels based on the intensity of the light it receives, as shown in Figure 8. Because the edges of the castellations 72 correspond to incremental units of drug dosage, the processor unit 23 can determine the amount of drug delivered by the injection device based on the number of transitions between high and low levels in the output of the sensor unit 26.

[0048] The length of time period t3 will be based on the dosage administered and when drug delivery is considered complete. Once drug delivery is complete, the number sleeve 70 will stop rotating relative to the dosage knob 12 and data collection device 20, and the signal from the sensor arrangement 26 will remain at a substantially constant level.

[0049] In some embodiments, the processor unit 23 is arranged to monitor the time period elapsed since the last transition or pulse in the output of the sensor unit 24. When the elapsed time period reaches a predetermined threshold t4, drug delivery is deemed complete and the processor unit 23 proceeds to determine the drug dose delivered to the user based on the number of transitions detected in the output of the sensor unit during the time period t3. In the particular example shown in Figures 7 and 8, there are eight transitions. The transitions correspond to the edges of the castellations and therefore correspond to incremental units of dosage in this particular embodiment, so the determined drug dose is eight units.

[0050] The processor unit 23 then stores the determined drug dose in main memory 24. The processor unit 23 may further store time stamp information that provides the user with a log recording the delivery of the drug.

[0051] The processor unit 23 may then power down the data collection device 20 to conserve battery power.

[0052] When the data collection device 20 is powered back on by the user activating the power switch 28, the processor unit 23 may control the display to display the determined drug dosage information 22a to aid in the user's memory. Optionally, the processor unit 23 may also monitor the time elapsed since the determined drug dosage was delivered and control the display to also display the elapsed time information. For example, the processor unit 23 may periodically switch the display 22 between displaying the determined drug dosage information 22a and displaying the elapsed time.

[0053] The processor unit 23 may further transmit the determined drug dosage and, if determined, timestamp information to another device, such as a computer 40, as shown in Figure 9. As described above, the output unit 27 is configured to transmit the information using a wireless communication link. Alternatively, the data collection device 20 may be connected to the computer 40 using a wired connection 41 that allows for uploading of information to the computer 40. The processor unit 23 may be configured to transmit the information to the computer 40 periodically.

[0054] The particular embodiments detailed above are intended to be merely illustrative of ways of implementing the invention. Many variations in the structure of the data collection device 20 and / or the injection device 1 are possible.

[0055] For example, the structures provided on the number sleeves need not be in the form of castellations, but rather the width of the castellations and the gaps between them may be individual as in the embodiment described above. There is no requirement that the dosage increments correspond exactly.

[0056] While the above-described embodiment utilizes an optical sensing device 26, other types of sensors may be used in addition to or instead of an optical sensor. For example, the sensing device may include a magnetic sensor, such as a Hall effect sensor. In one such example, one or more magnets are attached to the digit sleeve, so that when the digit sleeve is rotated relative to the data collection device, a magnetic field will change. In another example, a capacitance sensor may be used, where an element provided on the digit sleeve may affect the capacitance between two plates provided on the data collection device. In another example, a mechanical sensor including a mechanical switch and / or track may be used to detect relative motion.

[0057] Although the embodiment shown in FIG. 3 includes only one sensor, other embodiments can be devised in which the sensor device includes multiple sensors of one or more types.

[0058] In the embodiment described above, the injection button 11 included a central cavity 30 for receiving at least a portion of the data collection device 20, however, in other embodiments, the central cavity can be omitted from the injection button if not required by the data collection device 20.

[0059] Although the apparatus shown in FIG. 6 included cooperating structure in the form of a detent 71a on the dosage knob 12 and a protrusion 73a on the housing 21 of the data collection device 20, other types of cooperating structure or attachment methods may be used.

[0060] It will be noted that although the above embodiments are described in relation to collecting data from insulin injection pens, embodiments of the present invention may also be used for other purposes, such as monitoring the injection of other medications.

Claims

1. 1. A data collection device comprising: A mating apparatus configured to be attached to an injection device; a sensor device configured to detect movement of a movable dosage program component of the injection device relative to the data collection device during delivery of the medication; a processor unit configured to determine a drug dosage administered by the injection device based on the detected movement; The data collection device.

2. The data collection device of claim 1 , wherein the sensor arrangement comprises one or more of an optical sensor, a magnetic sensor, a capacitive sensor, and a mechanical sensor.

3. The data collection device of claim 2 , wherein the sensor arrangement includes an optical encoder.

4. 4. The data collection device of claim 3, wherein the processor unit is configured to monitor a period of time since receiving a pulse from an optical encoder and determine the drug dosage when the period of time exceeds a predetermined threshold.

5. The data collection device of any one of claims 1 to 4, wherein the processor unit is configured to obtain time stamp information for administration of the drug dosage and to store the determined drug dosage and said time stamp information.

6. 6. The data collection device of claim 5, wherein the processor unit is configured to transmit a log of determined medication dosage and time stamp information to another device.

7. 7. A data collection device according to any preceding claim, wherein the processor unit is configured to monitor the time elapsed since administration was detected and to control the display to display the determined drug dosage and the elapsed time.

8. 1. A medication administration device comprising: a movable component configured to move when a drug dosage is programmed into the injection device; A data collection device according to any one of claims 1 to 7. The drug administration device comprising:

9. 1. A medication administration device comprising: an injection device including a movable dose programming component configured to move when a medication dose is programmed into the injection device; A data collection device according to claim 3 or 4; Including, wherein the movable dose program component comprises a plurality of light barriers; The drug administration device.

10. 10. A medication delivery device according to claim 8 or 9, wherein the movable dosage programming component is configured to be stationary relative to the data collection device during programming of a dose into the injection device.

11. 11. A medication delivery device according to any one of claims 8, 9 or 10, wherein the movable component is a number sleeve providing a visible indication of the programmed dose.

12. A medication administration apparatus according to any one of claims 8 to 11, wherein the injection device is a disposable injection device and the data collection device is configured for releasable attachment to the injection device.

13. A medication administration apparatus according to any one of claims 8 to 11, wherein the injection device is a reusable injection device and the data collection device is configured to be permanently attached to the injection device.

14. A drug administration apparatus according to any one of claims 8 to 13, wherein the injection device is an injection pen.

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