HK40029626B - Data collection device - Google Patents

Description

Data collection device

Technical Field

This disclosure relates to a data collection device for attaching to an injection device and for collecting drug dosage information therefrom.

Background Technology

Many diseases require regular treatment with injectable medications. Such injections can be made using an injection device, administered by a healthcare professional or by the patient themselves. For example, type 1 and type 2 diabetes can be treated by the patient themselves by injecting insulin doses, such as once or several times a day. A pre-filled disposable insulin pen can be used as an injection device, for example. Alternatively, a reusable pen can be used. A reusable pen allows for the replacement of an empty cartridge with a new one. Either type of pen can be supplied with a set of unidirectional needles, which are replaced before each use. The insulin dose to be injected can then be manually selected at the insulin pen, for example, by turning the dose setting dial and observing the actual dose from the insulin pen's dose window or display. The dose is then injected by inserting the needle into the appropriate portion of the skin and pressing the insulin pen's dose setting dial or injection button. To monitor insulin injections, such as to prevent misuse of the insulin pen or to track the dose administered, information related to the condition and/or use of the injection device, such as information about the injected insulin dose, needs to be measured.

Summary of the Invention

In one aspect, a data collection device for releasably attaching to a rotatable dose setting dial of a drug delivery device includes a cavity configured to receive the dose setting dial; a coupling member disposed within the cavity on an inner surface of the data collection device and configured to releasably couple the data collection device to the dose setting dial; and an orientation element disposed within the cavity on the inner surface of the data collection device and configured to engage with a notch disposed on the dose setting dial.

In some embodiments, the data collection device includes a first end, a second end opposite the first end, and a wall extending between a portion of the periphery of the first end and a portion of the periphery of the second end. The first end, the second end, and the wall together define the cavity. The second end includes a notch configured to receive a dial sleeve of the drug delivery device; and the wall includes a groove configured to allow a dose setting dial of the drug delivery device to pass through the groove and be inserted into the cavity.

In some embodiments, the connecting member is disposed within a cavity on the inner surface of the first end.

In some embodiments, the orientation element is disposed on the inner surface of the wall of the data collection device.

In some embodiments, the connecting member is configured to connect the data collection device to the dose setting dial when the dose setting dial is received in the cavity of the data collection device.

In some implementations, the connecting member includes an elastically deformable component.

In some embodiments, the orientation element is a protrusion extending from the inner surface of the data collection device.

In some embodiments, rotation of the data collection device relative to the dose setting dial is prevented when the orientation element of the data collection device engages with a notch on the dose setting dial.

In some embodiments, when attached to the dose setting dial of the drug delivery device, rotation of the data collection device causes rotation of the dose setting dial.

In some embodiments, the device has a generally cylindrical shape.

In some embodiments, the data collection device further includes a light source configured to illuminate a portion of a component of the drug delivery device, the portion of the surface including one or more relatively reflective regions formed on the surface of the component; and an optical sensor configured to receive light reflected by at least the relatively reflective regions.

In some embodiments, the data collection device further includes a window configured to allow light emitted by the light source to pass through the window.

In some embodiments, the data collection device has a longitudinal axis and is configured to be fixed to the dose setting dial by: (i) orienting the data collection device such that the longitudinal axis is parallel to the rotation axis of the dose setting dial and the orienting element is aligned with a notch on the dose setting dial; and (ii) moving the data collection device in a direction perpendicular to the rotation axis of the dose setting dial.

In another aspect, the dose setting dial is configured to be releasably connected to one of the aforementioned data collection devices.

In some embodiments, the dose setting dial includes a channel configured to releasably engage with a coupling element of the data collection device; and a recess configured to engage with an orientation element of the data collection device.

In some implementations, the dose setting dial also includes a window.

In a further aspect, a system includes a drug delivery device comprising a housing; a rotatable dose setting dial; a dial sleeve at least partially located within the housing and including one or more opposing reflective areas formed on the surface of the dial sleeve; and one of the aforementioned data collection devices. The dial sleeve and the dose setting dial are rotatably connected during dose setting and dose resetting of the device, and rotatably separated during dose dispensing of the device.

In another aspect, a system includes one of the aforementioned dose setting dials and one of the aforementioned data collection devices.

Attached Figure Description

Figure 1 shows an exploded view of the injection device used with the data collection device;

Figure 2 depicts a data collection device attached to the injection device of Figure 1;

Figure 3a shows a cross-sectional view of the dosage setting dial of the injection device;

Figure 3b shows a perspective view of the dose setting dial of Figure 3a;

Figure 4 depicts a cross-sectional view of the data collection device;

Figure 5 shows a cross-sectional view of the data collection device;

Figure 6 shows a cross-sectional view of the data collection device attached to the injection device of Figure 1;

Figure 7 is a block diagram of the data collection device; and

Figure 8 shows a system in which a data collection device is connected to another device (such as a personal computer).

Detailed Implementation

In the following disclosure, embodiments will be described with reference to insulin injection devices. However, this disclosure is not limited to such applications and can be equally well applied to injection devices that dispense other medications.

Figure 1 is an exploded view of the drug delivery device. In this example, the drug delivery device is an injection device 1, such as Sanofi's insulin pen; however, the present invention is also compatible with other types and configurations of injection pens, as described below.

The injection device 1 in Figure 1 is a pre-filled injection pen, comprising a housing 2 and containing an insulin container 3, to which a needle 4 can be attached. The injection device 1 can be disposable or reusable. The needle is protected by an inner needle cap 5 and an outer needle cap 6 or alternative cap 7. The insulin dose to be dispensed from the injection device 1 can be programmed or 'dialed' by rotating the dose setting dial 8, and the currently programmed dose is then displayed through the dose window 9, for example, in multiples of units. For example, when the injection device 1 is configured to administer human insulin, the dose can be displayed in so-called International Units (IU), where 1 IU is the biological equivalent of approximately 45.5 micrograms of pure crystalline insulin (1/22 mg). Other units can be used in the injection device for delivering insulin analogs or other agents. It should be noted that the selected dose can be displayed just as well as in a manner different from that shown in the dose window 9 in Figure 1.

The drug delivery device 1 has a distal end and a proximal end. The term "distal" refers to a position relatively close to the injection site, and the term "proximal" refers to a position relatively further away from the injection site. In this embodiment, the needle 4 faces the distal end of the device 1, while the dose setting dial 8 faces the proximal end of the device 1. The device 1 has a longitudinal axis extending between the proximal and distal ends of the device 1.

The dosage window 9 may be in the form of an aperture in the housing 2, allowing the user to view a limited portion of the digital cannula 10, which is configured to move when the dosage setting dial 8 is rotated to provide a visual indication of the currently programmed dosage. The digital cannula 10 may be a rotating component when a dose is dispensed from the injection device 1.

In this example, the dose setting dial 8 includes one or more formations 11a, 11b, which facilitate programming by improving the grip felt by the user when holding the dose setting dial 12. In another example (not shown), the dose setting dial does not include formations. Attached data collection devices do not require the dose setting dial to have formations.

The dosage setting dial 8 includes a notch or groove 12 configured to engage with a protruding orientation element positioned on the data collection device. When the groove 12 engages with the orientation element of the data collection device, the data collection device is in a predetermined position. By aligning the groove 12 of the dosage setting dial with the orientation element of the data collection device, the orientation element helps to align the data collection device in the predetermined position.

This can improve the stability of the connection between the data collection device and the dose setting dial. For example, a tight fit and/or the use of a rubber-like material on the contact surfaces between the data collection device and the injection device will provide attachment, which on the one hand facilitates a stable connection in the sense that the two devices remain attached to each other, and on the other hand allows the two devices to be separated when needed. The rubber-like material will ensure a proper fit even on smooth surfaces, such as a dose setting dial with a smooth surface, such that rotation of the data collection device causes rotation of the dose setting dial, and vice versa.

The dosage setting dial 8 also includes a window 13, which is configured to allow light to pass through the dosage setting dial 8 and reach the internal components of the drug delivery device 1. The window 13 is further configured to allow light reflected by the internal components of the drug delivery device 1 to pass through the window 13 and exit from the device.

The dose setting dial 8 is configured to rotate to set the dose. This causes the dose setting dial 8 to move proximally away from the housing 2. When a dose is dispensed from the injection device 1, the dose setting dial 8 moves back towards the housing 2 (distally), but does not rotate. The rotation of the dose setting dial 8 also causes the dial sleeve 10 to move proximally out of the housing 2. When a dose is dispensed from the injection device 1, the dial sleeve 10 rotates and moves back (distally) into the housing 2, but the dose setting dial 8 does not rotate.

The injection device 1 can be configured such that rotating the dose setting dial 8 produces a mechanical click to provide acoustic feedback to the user. The digital cannula 10 interacts mechanically with a piston in the insulin container 3. When the needle 4 is inserted into the patient's skin, the user presses down the entire dose setting dial 8, which moves longitudinally relative to the housing 2 to allow the medication to be dispensed. During this dispensing operation, the insulin dose displayed in the display window 9 is expelled from the injection device 1. Most of the dose is actually injected into the patient while the needle 4 of the injection device 1 remains in the skin for a period of time after the dose setting dial 8 has been pressed. The expulsion of the insulin dose can also cause a mechanical click, however, it is different from the sound produced when the dose setting dial 8 is used.

In different implementations, during insulin dose delivery, the dose setting dial 8 is moved axially back to its initial position, i.e., without rotation, while the digital sleeve 10 is rotated to return to its initial position, for example, to display a dose of zero units.

The injection device 1 can be used for several injections until the insulin container 3 is emptied or the medication in the injection device 1 reaches its expiration date (e.g., 28 days after the first use).

Additionally, before the first use of the injection device 1, a so-called "prime shot" may be necessary to remove air from the insulin container 3 and needle 4, for example, by selecting 2 units of insulin and pressing down the dose setting dial 8 while keeping the needle 4 of the injection device 1 facing upwards. For ease of presentation, it will be assumed below that the amount expelled substantially corresponds to the injected dose, such that, for example, the dose of medication expelled from the injection device 1 is equal to the dose received by the user. However, the difference between the expelled amount and the injected dose (e.g., loss) may need to be considered.

Figure 2 is a perspective view of one end of the injection device 1 when attached to a data collection device 14 according to an exemplary embodiment. The data collection device 14 includes a housing 15 having an end plate 16 that forms a user interaction surface. The housing 15 may support optical user feedback, such as one or more LEDs (not shown). In some optional embodiments, the data collection device 14 includes a display (not shown).

The data collection device 14 is compatible with various existing injection devices 1, which have an integrated dial. The data collection device 14 is compatible with the injection device even when the dose setting dial does not rotate during dose administration, but an internal component located near the dose setting dial rotates during dose administration. The data collection device 14 allows this internal component to rotate for detection and measurement.

Figure 3a is a top view of the dose setting dial 8, and Figure 3b is a perspective view of the dose setting dial 8. The dose setting dial 8 has a generally circular cross-section and includes a recess 12 and a channel 18. As previously explained, the recess 12 is configured to engage with an orientation element of the data collection device. The recess may be a depression or notch that extends partially into the body of the dose setting dial 8. The channel 18 is configured to engage with a connecting element of the data collection device. The channel 18 is shaped such that it can receive a protrusion disposed on the data collection device. The shape of the channel 18 and the shape of the protrusion of the data collection device may be complementary to each other.

Figure 4 is a perspective view of a data collection device 14 according to some embodiments. The housing 15 includes a first end 19, a second end 20 opposite to the first end 19, and a wall 21 extending from at least a portion of the periphery of the first end 19 to at least a portion of the periphery of the second end 20. The first end 19, the second end 20, and the wall 21 together define a cavity 35 configured to receive a dose setting dial 8 of a drug delivery device 1. Other components, such as electronic component assemblies, may be housed within the housing.

The first end 19 may be a plate, such as a disk. Other components of the data collection device 14 may be housed within the housing 15 or mounted on the surface of the housing 15. For example, a connecting member 22 may be mounted on the inner surface of the first end 19. Alternatively, the connecting member may be mounted on the inner surface of the wall 21 or the second end 20. Other components, such as electronic component assemblies, may be housed within the main body of the first end.

The second end 20 includes a notch 37. The notch 37 can be configured to receive the dial sleeve 10 of the drug delivery device 1.

The wall 21 includes a groove 36 configured to allow the dose setting dial 8 to be inserted into the cavity 35. The groove 36 is sized sufficiently to allow the dose setting dial 8 to be inserted into the cavity 35. Alternatively, the groove 36 may be deformable to allow the dose setting dial 8 to be inserted into the cavity 35. For example, the wall may be at least partially made of a deformable or elastically deformable material. Other components, such as electronic component assemblies, may be housed within the body of the wall 21.

The volume of cavity 35 can be similar to or substantially the same as the volume of dose setting dial 8. This will help form a tight fit between dose setting dial 8 and cavity 35 of the housing.

When the data collection device 1 is fixed to the dose setting dial 8, the coupling member 22 is configured to engage with the channel 18 of the dose setting dial 8. The coupling member 22 may be a component attached to the housing 15, such as a resiliently deformable member (e.g., a spring or spring-loaded clip). Alternatively, the coupling member 22 may be a component that is part of the housing 15, such as a protrusion. In such an embodiment, the protrusion may be made of a resiliently deformable material.

Figure 5 is a cross-sectional view of the data collection device 14 according to some implementation schemes.

The housing 15 may also include an orientation element 23 configured to engage with a recess 12 located on the dose setting dial 8. The orientation element 23 may be a protrusion extending from the inner surface of the wall 21. When the data collection device 14 is fixed to the dose setting dial 8, the orientation element 23 engages with the recess 12 of the dose setting dial 8. When the orientation element 23 engages with the recess 12 of the dose setting dial 8, rotation of the data collection device 14 relative to the dose setting dial 8 is prevented; that is, the dose data collection device 14 and the dose setting dial 8 are rotatably locked.

The housing 15 may also include a sensor window 24 configured to allow light from a light source located within the data collection device 14 to pass through and enter the data collection device. The sensor window 24 may also be configured to allow light to pass through the sensor window 24 into the housing 15 and be received by an optical sensor located within the data collection device 14. In the illustrated embodiment, the sensor window 24 is located on the inner surface of the wall 21 and covers the light source 29 and the optical sensor 30. In alternative embodiments, the sensor window 24 may be located on other inner surfaces of the data collection device, such as the inner surface of the first end 19 or the inner surface of the second end 20.

Figure 6 is a cross-sectional view of the data collection device 14 when it is attached to the drug delivery device 1 according to some embodiments.

When attached to the drug delivery device 1, the dosage setting dial at least partially fills the cavity 35 formed by the first end 19, the second end 20 and the wall 21 of the data collection device 14.

The data collection device 14 is configured to detect and measure the rotation of the dial sleeve 10 when attached to the injection device 1.

The dial sleeve 10 rotates during dose dispensing. The data collection device 14 is configured to detect and measure the rotation of the dial sleeve 10 when attached to the injection device 1. The injection device 1 shown in FIG6 may also have other components that rotate when dispensing doses, such as a drive sleeve 31.

The data collection device 14 includes a housing 15 and an electronic component assembly 25 disposed inside the housing 15. The connecting component 22 of the data collection device 1 engages with the channel 18 of the dose setting dial 8, while the orientation element 23 of the data collection device 14 engages with the groove 12 located on the dose setting dial 8.

The engagement of the connecting member 22 in the channel 18 helps prevent the data collection device 14 from being removed from the dose setting dial 8, and it also provides a rotation lock.

When the dose setting dial 12 rotates during dose programming, the data collection device 14 also rotates. The engagement of the orientation element 23 in the groove 12 helps prevent the data collection device 14 from rotating independently of the dose setting dial 8. Additionally, an elastic pad (not shown), such as a foam rubber pad, can be provided between the inner surface of the data collection device 14 and the outer surface of the dose setting dial 8 to allow for dimensional tolerances between the dose setting dial 8 and the data collection device 14.

The electronic component assembly 25 includes a PCB 26 and a battery 27, for example, in the form of a coin cell. The PCB 26 may support multiple components, including a processor assembly 28, a light source 29, and an optical sensor 30. In these embodiments, the light source 29 is an infrared light source, and the optical sensor 30 is an infrared optical sensor. As shown in FIG6, in some embodiments, the light source 29 and the optical sensor 30 are supported on the side of the PCB adjacent to the dose setting dial 8.

Light source 29 allows light to propagate through sensor window 24 of data collection device 14. The dose setting dial has a window 13 that is transparent or substantially transparent to light. Therefore, light emitted by light source 29 passes through the dose setting dial 8 and illuminates the internal components. Specifically, the digital sleeve 10 is a hollow cylinder that extends to the proximal end of housing 2 and is releasably fixed to the dose setting dial 8. The cylindrical surface of the digital sleeve 10 thus sits below the dose delivery button 8 and is illuminated by infrared light. The dial sleeve 10 is provided with a pattern of relatively reflective and non-reflective areas on the cylindrical surface. For example, equally spaced and equally sized reflective and non-reflective portions can be arranged alternately.

During the dose dispensing operation, light source 29 illuminates a portion of the digital sleeve 10 that includes a pattern of relatively reflective and non-reflective areas; and optical sensor 30 receives light reflected by at least the relatively reflective areas. The output of optical sensor 30 is relayed to processor 28, which calculates the amount of rotation of digital sleeve 10 during the dose dispensing operation. Based on the amount of rotation, the delivered dose can be calculated. This can be done via data collection device 14 or via another computing device. Typically, any component located near the dose setting dial and rotating when a dose is dispensed from injection device 1 can be used as an internal component having a pattern of relatively reflective and non-reflective areas formed on its surface.

Reflective and non-reflective areas are arranged around a circumference on the outer surface of the digital sleeve 10. This arrangement allows for larger or more spaced reflective and non-reflective areas because a larger space is available on this surface of the digital sleeve 10.

This embodiment allows for minimized and constant optical path movement relative to the dial sleeve 10 during dose dispensing. This increases the already improved reliability of dose detection. This embodiment also features a simple mechanical design and construction.

Instead of having a light source and optical sensors, the electronic component assembly may include a non-contact magnetic sensor, such as a Hall effect sensor. In this embodiment, the rotatable component 10 includes a series of magnetic and non-magnetic regions, in place of relatively reflective and non-reflective regions, which are alternately spaced around the circumference of the rotatable component 10. The magnetic regions may be permanent magnets, such as regions containing magnetic particles or magnetic ink. As the magnetic and non-magnetic regions rotate past the magnetic sensor during dose dispensing, the magnetic sensor detects periodic changes in the strength and, optionally, the orientation of the magnetic field. This information can then be used to determine the amount (angle) of rotation of the rotatable component 10. The dose setting dial 8 is transmissive or partially transmissive to the magnetic field generated by the magnetic regions, thereby allowing the magnetic sensor to remotely detect the rotation of the rotatable component 10 without requiring a cutout or window in the dose setting dial 8.

When the data collection device 14 and the injection device 1 are fastened together, the electronic component assembly 25 is configured adjacent to the dose setting dial 8. The data collection device 14 effectively replaces the dose setting dial because the user interacts directly with the data collection device 14 in the same way they would interact with the dose setting dial to set and deliver the drug dose.

Electronic component assembly 25 includes multiple components, including PCB 26, light source 29, optical sensor 30, processor assembly, and battery 27. In some embodiments, light source 29 is an infrared light source, and optical sensor 30 is an infrared optical sensor. Window 13 of the dose setting dial is transparent or substantially transparent to infrared radiation. Therefore, light emitted by light source 29 passes through window 13 of dose setting dial 8 and illuminates the internal components. Specifically, digital sleeve 10 is a hollow cylinder that extends to the proximal end of housing 2 and moves longitudinally with dose setting dial 8 during dose setting. Digital sleeve 10 can be releasably fixed to dose setting dial 8 such that the annular end surface of dial sleeve 10 is situated below dose delivery button 8 and illuminated by infrared light from light source 29. Digital sleeve 10 is provided with a pattern of relatively reflective and non-reflective areas on the cylindrical end surface. For example, equally spaced and equally sized reflective and non-reflective portions can be arranged alternately. Alternatively, the drive sleeve 31 or another internal component may be provided with a pattern of relatively reflective and non-reflective areas.

During the dose dispensing operation, light source 29 illuminates a portion of a pattern comprising relatively reflective and non-reflective areas of digital sleeve 10; and optical sensor 30 receives light reflected by at least the relatively reflective areas as light passes beneath it. The output of optical sensor 30 is relayed to a processor (not shown), which calculates the amount of rotation of digital sleeve 10 during the dose dispensing operation. Based on the amount of rotation, the delivered dose can be calculated. This can be done via a data collection device or via another computing device.

Typically, it is necessary to know the type of injection device 1 to which the data collection device 14 is attached in order to determine the dispensed drug dose. Therefore, in some embodiments, the data collection device 14 only measures the amount of rotation (in degrees) of its internal components. This information is stored in the memory of the data collection device 14 and can be transmitted through the data collection device 14 to an external computing device, where it is combined with information about the type of injection device 1 to record the delivered drug dose.

The fixed structure and design of the embodiment of the data collection device 14 in Figure 6 has the advantage of simple mechanical construction (e.g., by minimizing relative movement), which provides accurate positioning of the optical sensor 30 relative to the injection device housing and internal components (e.g., the dose dial 8) including patterns of relatively reflective and non-reflective areas.

The drug delivery device 1 includes a longitudinal axis extending between its proximal and distal ends. A dose setting dial 8 is positioned toward the proximal end of the drug delivery device 1, and a digital cannula 10 extends distally from the bottom side of the dose setting dial 8. The axes of rotation of the dose setting dial 8 and the digital cannula 10 correspond to the longitudinal axis of the drug delivery device 1.

To secure the data collection device 14 to the drug delivery device 1, the orientation element 23 is aligned with the groove 12 on the dose setting dial 8. In this position, the groove 36 of the wall 21 and the notch 37 of the second end 20 are positioned so that they face the drug delivery device 1. The data collection device 14 then moves toward the drug delivery device 1 in a direction perpendicular to the longitudinal axis of the drug delivery device 1. As the data collection device moves toward the drug delivery device 1, the dial sleeve 10 is received in the notch 37 at the second end, and the dose setting dial 8 is received in the cavity 35 of the data collection device 1. When the dose setting dial is received in the cavity 35, the connecting member 22 of the data collection device 1 engages with the channel 18 of the dose setting dial 8, thereby connecting the data collection device 14 to the dose setting dial 8.

When the dose setting dial 8 is fully received in the cavity 35 of the data collection device 14, the orientation element 23 engages with the recess 12 of the dose setting dial 8. The orientation element 23 prevents the data collection device 14 from being incorrectly fixed to the dose setting dial 8, because for the data collection device 14 to be fully fixed to the dose setting dial 8, the orientation element 23 must be received in the recess 12. The orientation element 23 prevents attempts to fix the data collection device 14 to the dose setting dial 8 with incorrect orientation. Therefore, the data collection device 14 is fixed to a predetermined position on the dose setting dial 8.

Fixing the dose setting dial 8 to a predetermined position on the dose setting dial 8 ensures that the sensor window 24 of the data collection device 14 is aligned with the window 13 of the dose setting dial 8. With this orientation, the light source 29 can illuminate a pattern of relatively reflective and non-reflective areas on an internal component (e.g., digital sleeve 10) of the drug delivery device 1. The orientation element thus facilitates the alignment of the data collection device 14.

The data collection device 14 of this disclosure is directly attached to the dose setting dial of the drug delivery device. Previously, data collection devices were attached to the main housing of the drug delivery device. This could hinder user operation of the drug delivery device. Many such devices are attached to the dose indication window within the housing of the drug delivery device. This obscures the dose indication window, forcing the user to rely entirely on the data collection device to indicate the dispensed dose, which may reduce user trust in the drug delivery device. Some other such devices require additional cutouts or openings in the housing of the drug delivery device to view or connect internal moving parts. Cutting off a portion of the drug delivery device housing makes it more likely that dust and dirt will enter the delivery mechanism. This may also present problems related to the sterility of the drug delivery device.

The data collection device disclosed herein enables remote monitoring of the dosage dispensed from the drug delivery device without contact with or fastening to the main housing of the drug delivery device. The data collection device is configured to attach to and effectively replace the part of the drug delivery device that the user typically interacts with. When the user wishes to adjust the dosage, they grasp and rotate the housing 15 of the data collection device 14, which in turn rotates the dosage setting dial 8. The user can continue to observe the mechanical dosage indication window 9 of the drug delivery device. When the user wishes to inject a dose, they apply force to the proximal end of the data collection device. This then transmits the force to the dosage setting dial. The user will notice that there is no substantial difference in how they operate the drug delivery device due to the addition of the data collection device according to the invention.

The data collection device disclosed herein can use infrared light as an illumination source. This allows the external components of the drug delivery device to be made of plastic or other materials that are opaque to optical wavelengths but transparent or partially transparent to infrared wavelengths. No additional cuts, openings, etc., are required, but only appropriate areas of the drug delivery device can be made of infrared (IR)-transmitting materials, thereby effectively forming an infrared 'window'.

The relatively reflective and non-reflective areas of the pattern can be printed, deposited, etched, or otherwise directly produced onto the digital sleeve 10 or other suitable internal components during component manufacturing. In some examples, the internal components are located very close to the dose setting dial. The drug delivery device can then be assembled in the same manner as before using the same assembly methods and tools. Therefore, only minimal modifications are required to the design and manufacture of the drug delivery device to realize the present invention.

As discussed above regarding Figure 6, the light source 29 and optical sensor 30 in Figure 6 can be replaced by a magnetic sensor. The relatively reflective and non-reflective areas of the pattern on the rotatable component 10 can be replaced by alternating magnetic and non-magnetic areas, such that the periodic changes in the magnetic field are detected by the magnetic sensor as the rotatable component 10 rotates during the dose dispensing operation.

Figure 7 is a block diagram of the data collection device 14. The data collection device 14 includes a processor assembly 28, which includes one or more processors, such as a microprocessor, digital signal processor (DSP), application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), etc.; and memory units 32a and 32b, including program memory 32a and main memory 32b, which can store software executed by the processor assembly 28. The data collection device includes an infrared light source 29 and an infrared optical sensor 30. The processor assembly 28 controls the operation of the light source 29 and the optical sensor 30 and receives signals from the optical sensor 30.

The data collection device 14 has a power source 27, which may be a battery, such as a button cell. The data collection device 14 may optionally include a switch 33 configured to be triggered when a dose is dispensed or shortly before dose dispensing. For this purpose, the switch 33 may include a pressure or touch-sensitive area, such as a piezoelectric switch, in the endplate 16 of the data collection device 14. The switch 33 may control the application of electricity from the power source 27 to the processor assembly 28 and other components of the data collection device 14.

The switch can be a "wake-up" switch, which activates the data collection device 14 when operated. The wake-up switch can be implemented optically as an "optical wake-up sensor." Specifically, the lower rotatable component 10 can be white (or black). When the rotatable component 10 is rotated, the relatively reflective and non-reflective areas of the rotatable component 10 move in front of the optical wake-up sensor, and reflectivity and/or color changes can be detected, thereby providing a wake-up signal to other electronic components. This reflectivity or color change can also be used to determine the start and end times of the injection process. In this case, the switch, as previously described, can function to wake up the electronic components (including the light source and optical sensor), and the optical switch can use reflectivity or color changes to determine the start and end times of the injection process. This may help determine whether the injection process has occurred or whether the initiation process has occurred. Additionally, the color/reflectivity switch can be used to determine how long the button has been pressed and to observe whether the user has adhered to the dwell time.

It also includes a timer 34. The processor component 28 can use the timer 34 to monitor the length of time elapsed since the injection was completed, which is determined using a switch 33. Optionally, the processor component 28 can also compare the elapsed time with a predetermined threshold to determine whether the user might attempt to administer another injection too quickly after the previous one, and if so, generate an alarm (e.g., an audible signal) and/or generate an optical signal (e.g., flashing one or more LEDs). The data collection device 14 may include multiple LEDs or other light sources to provide optical feedback to the user. For example, the LEDs may use different colors and/or light patterns, such as flashing at a constant or varying period. On the other hand, if the elapsed time is very short, it can indicate that the user is administering a dose of medication as a “split dose,” and the processor component 28 can store information indicating that the dose is delivered in this manner. In such a scenario, the elapsed time is compared with a predetermined threshold ranging from a few seconds (e.g., 10 seconds) to several minutes (e.g., 5 minutes). According to an example, the predetermined threshold is set to 2 minutes. If the elapsed time since the last injection is 2 minutes or less, the processor component 28 stores information indicating that the dose should be delivered as a “fractionated dose”. Another optional purpose of monitoring the elapsed time by the processor component 28 is to determine when the elapsed time exceeds a predetermined threshold, indicating that the user may have forgotten to receive another injection, and if so, to generate an alarm.

The processor is further configured to store data regarding date and/or time information, data regarding information from the optical sensor 30, or a combination thereof. Specifically, the memory is configured to store a combination of date and/or time information and internal component rotation information retrieved from the output data of the optical sensor 30. In this way, the memory is able to store a log that provides a history of information regarding the rotation of the digital sleeve 10 (or other internal components). The data may, for example, be stored in the main memory 32a. Alternatively, the data may be stored in a separate data storage segment (not shown) of the memory.

Since the digital cannula or other internal components rotate as the medication is dispensed from the injection device 1, the rotation angle measured by the optical sensor 30 is proportional to the dispensed medication dose. It is not necessary to determine the zero level or absolute amount of medication contained in the injection device 1. In this way, the sensor configuration is simpler compared to sensor configurations used for absolute position detection. Furthermore, since it is not necessary to monitor the numbers or scale markings on the digital cannula 10 displayed through the dose window 9, the data collection device 14 can be designed so that it does not obstruct the dose window 9.

Output 38 is provided, which may be a wireless communication interface for communicating with another device via a wireless network (e.g., Wi-Fi, or NFC); or an interface for a wired communication connection, such as a socket for accepting a Universal Serial Bus (USB), mini-USB, or micro-USB connector. Figure 8 depicts an example of a system in which the data collection device 14 is connected to another device (e.g., a personal computer 39) via a wireless connection 40 for data transfer. Alternatively or additionally, the data collection device 14 may be connected to another device via a wired connection. For example, the processor component 28 may store the measured rotation angle and timestamp (including date and/or time) of the digital cannula 10 used for injection when administered by a user, and subsequently transfer the stored data to the computer 39. The computer 39 may be configured to calculate the administered dose based on other information input by the user or medical personnel regarding the type of injection device and the type of medication. The computer 39 maintains a treatment log and/or sends treatment history information to a remote location, for example, for review by a medical personnel.

According to some implementations, the data collection device 14 can be configured to store data, such as the rotation angle of the digital cannula 10 and timestamps for up to 35 injection events. This would be sufficient to store approximately one month's treatment history for a once-daily injection therapy. The data storage is organized in a first-in, first-out (FIFO) manner, ensuring that the most recent injection event is always present in the memory of the data collection device 14. Once transferred to the computer 39, the injection event history in the data collection device 14 is deleted. Alternatively, data is retained in the data collection device 14 and the oldest data is automatically deleted immediately after new data is stored. In this way, a log in the data collection device is built up over time during use and will always include the most recent injection event. Alternatively, other configurations may include storage capacity for 70 injection events (twice daily), 100 injection events (3 months), or any other suitable number, depending on the user's therapy needs and/or preferences.

In another implementation, output 58 may be configured to transmit information using a wireless communication connection and/or processor component 28 may be configured to periodically transmit such information to computer 39.

The specific embodiments described in detail above are intended only as examples of how the invention can be implemented. Various modifications to the construction of the data collection device 14 and/or the injection device 1 are conceivable.

In particular, while the above embodiments have been described with respect to data collection from an insulin syringe pen, it should be noted that embodiments of this disclosure can be used for other purposes, such as monitoring the injection of other medications. Although the data collection device has been primarily described as comprising a single infrared light source 29, the data collection device may include multiple light sources 29. The multiple light sources 29 may be supported at different locations on the electronic component assembly 25 and may be angled and/or concentrated such that specific portions of the internal component 10 are illuminated from a specific angle when the data collection device is attached to the dose setting dial.

The data collection device 14 may optionally include a display (not shown), which may, for example, occupy the end plate 16 of the data collection device 14. Various information may be displayed, such as the length of time elapsed since the injection was completed, and warning messages in case the user attempts to administer another injection too quickly after the previous one.

Claims (14)

1. A data collection device for releasably attaching to a rotatable dose setting dial of a drug delivery device, the data collection device comprising: First end; The second end, opposite to the first end; A cavity configured to receive the dose setting dial; A wall extending between a portion of the periphery of the first end and a portion of the periphery of the second end, wherein the first end, the second end, and the wall together define the cavity, wherein the second end includes a notch configured to receive a dial sleeve of the drug delivery device, and wherein the wall includes a groove configured to allow the dose setting dial of the drug delivery device to pass through the groove and be inserted into the cavity; A connecting component, wherein the connecting component is disposed within a cavity on the inner surface of the data collection device and configured to releasably connect with a channel of the dose setting dial; and A directional element is disposed within a cavity on the inner surface of the data collection device and configured to engage with a notch disposed on the dose setting dial; wherein, when attached to the dose setting dial of the drug delivery device, rotation of the data collection device causes rotation of the dose setting dial. 2. The data collection device according to claim 1, wherein the connecting member is disposed within a cavity on the inner surface of the first end. 3. The data collection device according to claim 1 or claim 2, wherein the orientation element is disposed on the inner surface of the wall of the data collection device. 4. The data collection device according to any one of the preceding claims, wherein the connecting member is configured to connect the data collection device to the dose setting dial when the dose setting dial is received in the cavity of the data collection device. 5. The data collection apparatus according to any one of the preceding claims, wherein the connecting member comprises an elastically deformable member. 6. The data collection device according to any one of the preceding claims, wherein the orientation element is a protrusion extending from the inner surface of the data collection device. 7. The data collection device according to any one of the preceding claims, wherein rotation of the data collection device relative to the dose setting dial is prevented when the orientation element of the data collection device engages with a notch on the dose setting dial. 8. The data collection device according to any one of the preceding claims, wherein the data collection device has a generally cylindrical shape. 9. The data collection apparatus according to any one of the preceding claims, wherein the data collection apparatus further comprises: A light source configured to illuminate a portion of a component of the drug delivery device, the portion of the surface including one or more opposing reflective regions formed on the surface of the component; and An optical sensor configured to receive light reflected by at least the relative reflective regions. 10. The data collection apparatus of claim 9, wherein the data collection apparatus further comprises a window configured to allow light emitted by the light source to pass through the window. 11. The data collection device according to any one of the preceding claims, wherein the data collection device has a longitudinal axis and is configured to be fixed to the dose setting dial in such a way that: Positioning the longitudinal axis parallel to the rotation axis of the dose setting dial and aligning the orientation element with the notch on the dose setting dial; and The data collection device is moved in a direction perpendicular to the axis of rotation of the dose setting dial. 12. A system comprising: A drug delivery device, comprising: shell; Rotatable dosage setting dial; A dial sleeve, the dial sleeve being at least partially located within the housing and including one or more opposing reflective areas formed on the surface of the dial sleeve, wherein the dial sleeve and the dose setting dial are rotatably connected during dose setting and dose resetting of the device, and rotatably separated during dose dispensing of the device; and The data collection apparatus according to any one of claims 1-11. 13. The system of claim 12, wherein the dose setting dial includes a channel configured to be releasably coupled to a coupling element of the data collection device; and A notch is configured to engage with an orientation element of the data collection device. 14. The system of claim 12 or 13, wherein the dose setting dial further includes a window.