Data acquisition device attached to an 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 Art

[0002] In various diseases, regular treatment by injection of drugs is required. Such injections can be performed using an injection device and are applied by medical staff or the patient himself / herself. As an example, type 1 and type 2 diabetes can be treated by the patient himself / herself, for example, by injecting insulin doses once or several times a day. For example, a pre-filled disposable insulin pen can be used as an injection device. Alternatively, a reusable pen can also be used. The reusable pen can replace an empty drug cartridge with a new one. Both pens can be equipped with a set of disposable needles that are replaced before each use. Then, in an insulin pen, for example, by turning a dosage knob and observing the actual dosage from a dosage window or display of the insulin pen, the insulin dosage to be injected can be manually selected. Then, the needle is inserted into an appropriate skin area and the injection button of the insulin pen is pressed to inject the dosage. It is desirable to measure information regarding the state and / or use of the injection device, such as information on the insulin dosage already injected, so that the insulin injection can be monitored, for example, to prevent incorrect handling of the insulin pen or to follow the progress of the dosage already applied.

Summary of the Invention

Means for Solving the Problems

[0003] According to one embodiment, the data acquisition device includes a fitting device configured to be attached to an injection device, a sensor device configured to detect the movement of a movable dosage program component of the injection device relative to the data acquisition device during drug delivery, and a processor device configured to determine the drug dosage administered by the injection device based on the detected movement.

[0004] In this approach, the data collection device can collect drug dosage information without relying on additional user intervention, improving the reliability of drug administration recording and logging. Furthermore, displaying the previous dosage when programming the next dosage into the injection pen can serve as a memory aid for the user.

[0005] The sensor device may include one or more of the following: optical sensors, magnetic sensors, capacitive sensors, and mechanical sensors. For example, the sensor device may include an optical encoder device. The processor device is configured to monitor the time elapsed since the pulse was output by the optical encoder and to determine the drug dosage if the time exceeds a predetermined threshold. This can enable reliable identification of the end point of the injection stroke. Alternatively, or in addition, the sensor device may include mechanical switches and / or tracks for detecting relative motion.

[0006] The processor device is configured to acquire timestamp information for detected drug doses and store the determined drug dose and the timestamp information to provide, for example, a log of administered injections. In this case, the data acquisition device may also include an output interface that allows the stored drug dose and timestamp information to be transmitted to an external device, such as a computer, via a communication link. The output interface communicates with the external device via a wired or wireless link. It is configured to communicate.

[0007] In addition, or alternatively, the processor device is configured to monitor the elapsed time after administration detection and to control the display to show the determined drug dosage and elapsed time. By displaying such information, the data acquisition device can provide the user with further memory assistance.

[0008] In any of the apparatuses described above, the data acquisition device may be attachable to the dosage program component of an injection device, which is moved by the user to program the dosage of the drug to be administered, so as to move together with the dosage program component. In one such embodiment, the data acquisition device is configured so that the user can program the dosage of the drug to be administered to the injection pen by gripping and moving the data acquisition device rather than gripping and moving the dosage program component. To facilitate such programming, the data acquisition device may be configured to provide a larger contact surface for the user to grip compared to the dosage program component, or may include other structures that allow the user to program the dosage of the drug more easily. This is particularly useful when the user's dexterity is limited.

[0009] In some embodiments, the data acquisition device is removably attached to the injection device. In other embodiments, the data acquisition device is permanently attached to the injection device.

[0010] This embodiment further provides a drug delivery device including the data acquisition device and the injection device. An example of such a drug delivery device may include an injection device including a movable dosage program component configured to move when a drug dosage is programmed into the injection device, and a data acquisition device including an optical sensor, wherein the movable dosage program component includes a plurality of light barriers.

[0011] The drug delivery device is configured such that the movable dosage programming component does not move relative to the data acquisition device while the dosage is being programmed into the injection device. Such an arrangement can limit relative motion to the drug delivery period, thus eliminating 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 one embodiment where it is not necessary to distinguish between increasing and decreasing dosage levels, multiple sensors are not required. Therefore, the sensor device can be configured using a single sensor. This results in a relatively simpler device and fewer data processing requirements compared to a sensor device with multiple sensors.

[0012] The injection device and the data acquisition device may include structures that cooperate to attach the data acquisition device to the injection device. In some embodiments, one of the projections and recesses is provided on the injection device, and the other projection and recess is provided on the mating device of the data acquisition device, for example, to result in a clip-on or snap-on attachment.

[0013] In some embodiments, the injection device is a disposable injection device, and the data acquisition device is configured to be removably attached to the injection device. In other embodiments, the injection device is a reusable injection device, and the data acquisition device is permanently attached to the injection pen.

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

[0015] Next, illustrative embodiments of the present invention will be described with reference to the attached drawings. [Brief explanation of the drawing]

[0016] [Figure 1]This is an exploded view of an injection device used with a data acquisition device according to one embodiment of the present invention. [Figure 2] This is a diagram of a data acquisition device according to one embodiment, which is attached to the injection device shown in Figure 1. [Figure 3] Figure 2 is a block diagram of the data acquisition device. [Figure 4] Figure 1 is a partial perspective view of the injection device. [Figure 5] Figure 1 is a perspective view of the movable drug dosage program component of the injection device. [Figure 6] This is a partial cross-sectional view of the data acquisition device in Figure 3 and the injection device in Figure 1 when they are installed together. [Figure 7] Figure 3 is a graph showing the light intensity received by the sensor device of the data acquisition device. [Figure 8] Figure 7 is a graph showing the output of the sensor device based on the intensity of the light it receives. [Figure 9] Figure 3 shows a system in which data from a data acquisition device is transmitted to other devices. [Modes for carrying out the invention]

[0017] Embodiments of the present invention will be described below with reference to insulin injection devices. However, the present invention is not limited to such applications and can be used equally well with injection devices that release other drugs.

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

[0019] The injection device 1 of FIG. 1 is a pre-filled disposable injection pen, which includes a housing 10 and houses 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 by turning the dosing knob 12, or can be "dialed in". The currently programmed dose is displayed via a dosing window 13, for example, in multiples of units. For example, if the injection device 1 is configured to administer human insulin, the dose is displayed in so-called international units (IU), where 1 IU is approximately 45.5 micrograms of biologically equivalent pure crystalline insulin (1 / 22 mg). Other units may be used in injection devices that deliver insulin analogs or other drugs. Note that the selected dose can be displayed well even if it is different from that shown in the dosing window 13 of FIG. 1.

[0020] The dosing window 13 may be in the form of an aperture in the housing 10. Through the dosing window 13, the user can see a limited portion of a numeric sleeve 70 configured to move when the dosing knob 12 is turned, thus providing a visual indication of the currently programmed dose. The dosing knob 12 rotates on a helical path with respect to the housing 10 when turned during programming.

[0021] In this example, the dosing knob 12 includes one or more structures 71a, 71b, 71c, thereby facilitating the attachment of a data collection device described below in this specification.

[0022] The injection device 1 is configured such that a mechanical click sound is generated when the dose knob 12 is turned, providing acoustic feedback to the user. The digital sleeve 70 mechanically interacts with the piston within the insulin container 14. When the needle 15 is inserted into the patient's skin portion and the injection button 11 is pressed, the insulin dose displayed on the display window 13 is to be released from the injection device 1. Most of the dose is actually injected into the patient's body while the needle 15 of the injection device 1 remains within the skin portion after the injection button 11 has been pressed. When the insulin dose is released, a mechanical click sound also occurs. However, that click sound is different from the sound generated when using the dosing knob 12.

[0023] In this embodiment, during delivery of the insulin dose, the dosing knob 12 moves axially, i.e., without rotating, back towards its initial position, while the digital sleeve 70 rotates back to its initial position, displaying, for example, a dose of zero units.

[0024] The injection device 1 can be used for several injection procedures until the insulin container 14 is empty or the expiration date of the drug within the injection device 1 (e.g., 28 days from first use) is reached.

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

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

[0027] As shown in Figure 3, the data acquisition device 20 further includes a processor unit 23 which includes one or more processors such as a microprocessor, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), or a field-programmable gate array (FPGA), and together with it, memory units 24, 25 which include a program memory 25 and a main memory 24 that can store software executed by the processor unit 23.

[0028] A sensor device 26 is provided which includes one or more sensors. In this particular example, the sensor device 26 is an optical encoder which includes a light source 26a such as a light-emitting diode (LED) and a photodetector 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 that accepts a Universal Serial Bus (USB), mini USB, or micro USB connector.

[0030] The power switch 28 is provided together with the battery 29. In one embodiment, the power switch 28 is configured to respond to pressure applied to the display 22 by turning the data acquisition device 20 on or off.

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

[0032] Figure 5 shows the numeral sleeve 70. In this particular embodiment, the castellation 72 is formed on one end of the numeral sleeve 70. The castellation 72 is provided on one end of the numeral sleeve 70, which can act as a light barrier against the light emitted by the light source 26a.

[0033] In the specific example shown in Figure 5, twelve castellations 72 are provided. The twelve castellations and the gaps between them have widths selected to result in 24 “edges” to accommodate dose increment units up to 24 units, which is the maximum dose indicated on the numeral 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 numeral sleeve 70 is positioned to rotate spirally in one direction when programming a dose to the injection device 1 using the dosage knob 12, and to rotate spirally in the opposite direction during drug dose delivery by the injection device 1.

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

[0036] As shown in Figure 6, the dosing knob 12 and the housing 21 of the data acquisition device 20 include cooperative structures 71a, 73a. In this particular embodiment, these structures take the form of projections 73a provided on the housing 21 of the data acquisition device 20 and return stoppers 71a provided on the dosing knob 12. As shown in Figure 1, the structures 71a, 71b, 71c have only a limited range, and therefore the data acquisition device 20 cannot rotate relative to the dosing knob 12 once attached to it.

[0037] Since the data acquisition device 20 and the dosage knob 12 cannot rotate relative to each other, they move together when the dosage is programmed into the injection device 1. This can provide a more ergonomic device because the data acquisition device 20 can have a larger surface area that the user can grasp and rotate during dosage programming. Alternatively, the data acquisition device 20 may have a structure on its outer surface that facilitates the rotation of the data acquisition device 20 and, therefore, the dosage knob 12.

[0038] In an arrangement in which the data acquisition device 20 is removably attached to the injection device 1, the cooperative structures 71a and 73a can provide a clip-type arrangement that allows for easy removal of the data acquisition device 20. Such an arrangement is useful when the data acquisition device 20 is used with a disposable injection device 1 because it allows the data acquisition device 20 to be removed from the injection device 1 and reused, or provides the user with greater flexibility by allowing the data acquisition device 20 to be attached and removed at will.

[0039] Alternatively, the cooperative structures 71a and 73a can be configured to permanently attach the data acquisition device 20 to the injection device 1, for example, using a "snap-fit". In other embodiments, the data acquisition device 20 can be permanently attached in other ways, for example, by adhesive. It can be attached. Such permanent attachments are useful when the injection device 1 is reusable.

[0040] The number and / or position of the cooperative structures 71a, 73a are configured such that the data acquisition device 20 is attached to the injection device 1 in only one specific position. In this particular example, the housing 21 of the data acquisition device 20 includes an aperture 74 through which light emitted by the light source 26a and light detected by the photodetector 26b can pass when the data acquisition device 20 is in a predetermined position. The cooperative structures 71a, 73a are positioned such that when the data acquisition device 20 is attached to the injection device 1, the aperture 74 of the housing 21 of the data acquisition device 20 aligns with an aperture 31 on the side wall of the cavity 30 of the injection button 11.

[0041] As indicated by arrow 75 in Figure 6, the light emitted by the light source 26a thus passes through apertures 74 and 31 and enters the injection button 11. If the castellation 72 of the numeral sleeve 70 is visible from aperture 31, the light will be reflected from the castellation 72 and return through apertures 31 and 74, and the photodetector 26b can detect this light. Since the reflectivity of the castellation 72 is different from the reflectivity of the inner surface of the injection button 11, the amount of light detected by the photodetector 26b will depend on how much of the castellation 72 is visible from aperture 31. In some embodiments, the sensor device 26 is configured to emit and / or detect only light with specific polarization characteristics in order to mitigate the effects of stray light entering aperture 74.

[0042] Figure 7 is a graph showing the change in light intensity received by the photodetector 26b while the drug dose is programmed and delivered. Figure 8 is a graph showing the output generated by the sensor device 26 of this embodiment.

[0043] As described above, during period t1 in Figures 7 and 8, while the dose is being programmed into the injection device 1, the dose knob 12 and the numeral sleeve 70 rotate spirally. In this particular embodiment, the data acquisition device 20 moves together with the dose knob 12, so the amount of light reflected back to the photodetector 26b should remain substantially constant. This is because the relative rotational motion between the numeral sleeve 70 and the data acquisition device 20 is minimal or nonexistent. Between the completion of the dose programming and the start of the injection, shown as period t2 in Figure 7, the numeral sleeve 70, the dose knob 12, and the data acquisition device 20 are not moved by the user, so the amount of reflected light should also remain substantially constant.

[0044] Therefore, as shown in Figure 8, the output of the sensor device 26 is substantially constant during periods t1 and t2. The actual output level during periods t1 and t2 will depend on whether the castellation 72 is visible from the aperture 31, and if so, to what extent the aperture is covered by the castellation 72.

[0045] During drug delivery, as shown in Figures 7 and 8 as period t3, the numeral sleeve 70 rotates spirally, while the dosage knob 12 moves only axially without rotating. Thus, the numeral sleeve 70 rotates relative to the data acquisition device 20.

[0046] During period t3, the castellation 72 of the numeral sleeve 70 moves across the aperture 31 as the numeral sleeve 70 rotates relative to the dosage knob 12 and the data acquisition device 20, and accordingly, the intensity of light received by the photodetector 26b changes, as shown in Figure 7. In this particular example, since the numeral sleeve 70 is more reflective than the inner surface of the injection button 11, the highest light intensity level shown in Figure 7 is due to the castellation 72. This corresponds to the position where the amount covering aperture 31 is maximized.

[0047] During period t3, the output of the photodetector 26b will switch between high and low levels based on the intensity of the light it receives, as shown in Figure 8. Since the edges of the castellation 72 correspond to incremental units of drug dosage, the processor device 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 device 26.

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

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

[0050] Next, the processor device 23 stores the determined drug dosage in the main memory 24. The processor device 23 can also store timestamp information to provide the user with a log recording the delivery of the drug.

[0051] Next, the processor unit 23 can turn off the power to the data acquisition device 20 in order to conserve battery power.

[0052] When the user activates the power switch 28 and the data acquisition device 20 is powered on again, the processor unit 23 can control the display to show the determined drug dosage information 22a to aid the user's memory. In some cases, the processor unit 23 can also monitor the elapsed time since the determined drug dosage was delivered and control the display to show that elapsed time information as well. For example, the processor unit 23 can periodically switch the display 22 between displaying the determined drug dosage information 22a and displaying the elapsed time.

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

[0054] The specific embodiments described in detail above are merely illustrative of ways in which the present invention can be carried out. Many variations in the structure of the data acquisition device 20 and / or the injection device 1 are possible.

[0055] For example, the structure provided on the number sleeve does not need to be in the form of a castellation, and the width of the castellation and the gaps between them may be as individual as in the embodiment described above. There is no need to precisely match the increment units of the medication dosage.

[0056] The embodiments described above utilize the light sensing device 26, but other types of sensors may be used in addition to or instead of the 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 number sleeve, and therefore, as the number sleeve rotates relative to the data acquisition device, the magnetic field changes. In another example, a capacitive sensor may be used, in which case an element provided on the number sleeve can affect the capacitance between two plates provided on the data acquisition device. In yet another example, mechanical sensors including mechanical switches and / or tracks may be used to detect relative motion.

[0057] The embodiment shown in Figure 3 includes only one sensor, but other embodiments can be devised that include one or more sensors of the type of sensor device.

[0058] In the embodiments described above, the injection button 11 included a central cavity 30 that receives at least a portion of the data acquisition device 20, but in other embodiments, the central cavity can be omitted from the injection button if it is not required in the data acquisition device 20.

[0059] The device shown in Figure 6 includes a cooperative structure in the form of a stopper 71a on the dosage knob 12 and a projection 73a on the housing 21 of the data acquisition device 20, but other types of cooperative structures or mounting methods may also be used.

[0060] While the embodiments described above relate to collecting data from an insulin injection pen, it should be noted that embodiments of the present invention can also be used for other purposes, such as monitoring the injection of other medications.

Claims

1. A data collection device, which: housing; A fitting device configured to be attached to the dispensing knob of an injection device such that the housing surrounds at least a portion of the outer surface of the dispensing knob in a circumferential direction, and so that the user can grasp and rotate the housing to rotate the dispensing knob together with the housing; A magnetic sensor device configured to detect relative movement between a component of an injection device and the magnetic sensor device; and Including a processor device, The magnetic sensor device is configured to detect the relative movement of at least one magnet to the magnetic sensor device when the data acquisition device is attached to the injection device, and the at least one magnet is coupled to the component when the data acquisition device is attached to the injection device.

2. Furthermore, the data acquisition device according to claim 1 further includes one or more of an optical sensor, a capacitive sensor, and a mechanical sensor.

3. The data acquisition device according to claim 1, wherein the magnetic sensor device includes at least one Hall effect sensor.

4. The data acquisition device according to claim 1, wherein the fitting device includes a clip-type arrangement for attaching to a medication dosage knob.

5. The data acquisition device according to claim 1, wherein the mating device is configured to be attached to the medication dosage knob using a snap-fit.

6. The data acquisition device according to claim 1, wherein the processor device is configured to determine the drug dosage based on at least the detected relative movement.

7. The data acquisition device according to claim 6, wherein the processor device is configured to acquire timestamp information regarding the administration of a drug dosage and to store the determined drug dosage and the timestamp information.

8. The data acquisition device according to claim 1, further comprising a wireless communication interface for wirelessly transmitting information to an external device.

9. The data acquisition device according to claim 8, wherein the information includes the amount of drug administered by the injection device.

10. The data acquisition device according to claim 1, wherein the processor device is configured to monitor the elapsed time after delivery of the detected drug and to control the output based on the elapsed time.

11. The data acquisition device according to claim 1, further comprising a battery and a power switch configured to turn the data acquisition device on or off in response to pressure applied to the data acquisition device.

12. A drug administration device, which includes: Injection device; A data collection device, which: housing; A fitting device configured to be attached to the dispensing knob of an injection device such that the housing surrounds at least a portion of the outer surface of the dispensing knob in a circumferential direction, and so that the user can grasp and rotate the housing to rotate the dispensing knob together with the housing; A magnetic sensor device configured to detect relative movement between a component of an injection device and the magnetic sensor device; and The data acquisition device, including a processor unit, and When the data acquisition device is attached to the injection device, at least one magnet is coupled to the component. Includes, The drug delivery device is configured such that the magnetic sensor device detects the relative movement of at least one magnet to the magnetic sensor device when the data acquisition device is attached to the injection device.

13. The drug delivery device according to claim 12, wherein the drug delivery device is configured such that its components do not move relative to a magnetic sensor device while the dose is being programmed into the injection device.

14. The drug delivery device according to claim 12, wherein the magnetic sensor device is configured to detect the relative movement of components during drug delivery.

15. The drug delivery device according to claim 12, wherein the data acquisition device can be removably attached to the injection device.

16. The drug dispensing device according to claim 12, wherein the components include a numbered sleeve.

17. The drug delivery device according to claim 16, wherein the number sleeve rotates in one direction when programming the dose into the injection device and rotates in the opposite direction during drug delivery.

18. The drug delivery device according to claim 12, wherein the injection device includes a disposable injection device, a reusable injection device, or an insulin injection device.

19. The drug delivery device according to claim 12, wherein the injection device includes a drug.

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