Auxiliary device for an injection device

Abstract

To provide an injection device which monitors insulin injection, for instance which prevents false handling of an insulin pen.SOLUTION: A supplementary device for an injection device 1 is disclosed. The injection device has an adjustment dial 8 rotatably mounted about an axis at a proximal end thereof and the supplementary device is attachable to the adjustment dial. The supplementary device comprises a sleeve 23 adapted to be located over the adjustment dial when the supplementary device is attached to the injection device. The supplementary device further comprises an axial attachment member. The axial attachment member is arranged to be moved by insertion of the adjustment dial into the sleeve from an initial position in which it allows axial movement of the adjustment dial into the sleeve to an engaged position in which it engages the adjustment dial to axially attach the supplementary device to the adjustment dial.SELECTED DRAWING: Figure 3

Description

Technical Field

[0001] The present disclosure relates to an auxiliary device for an injection device, such as a data collection device attached on top of an adjustment dial of an injection device.

Background Art

[0002] There are various diseases that require regular treatment by injection of drugs. Such injections can be performed using an injection device applied by a medical worker 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. With a reusable pen, it is possible to replace an empty drug cartridge with a new one. A set of one-way needles is attached to any pen, and these needles are replaced every time before use. Then, for example, by turning an adjustment dial and observing the actual dose from a dose window or display of the insulin pen, the insulin dose scheduled for injection can be manually selected with the insulin pen. Then, the needle is inserted into a suitable skin portion, and the dose is injected by pressing an injection button of the insulin pen.

[0003] It is desirable to measure information related to the state and / or use of an injection device, such as information on the insulin dose already applied, so as to be able to monitor insulin injections, for example, to prevent incorrect handling of an insulin pen or to track the dose already applied.

Summary of the Invention

Means for Solving the Problems

[0004] A first aspect of the present disclosure is an auxiliary device for an injection device including an adjustment dial rotatably attached around an axis at a proximal end, wherein: A sleeve applied to be positioned above the adjustment dial when the auxiliary device is attached to the injection device; An axially mounting member arranged to move from an initial position that allows axial movement of the adjustment dial into the sleeve by insertion of the adjustment dial into the sleeve to an engagement position where the adjustment dial engages to attach the auxiliary device to the adjustment dial; Provided is an auxiliary device including these.

[0005] In some embodiments, the axially mounting member can be applied to engage the adjustment dial such that axial movement of the adjustment dial relative to the sleeve is restricted in the engagement position.

[0006] The auxiliary device can further include a rotation-direction connecting member arranged to non-rotatably connect the sleeve to the adjustment dial such that rotation of the auxiliary device causes rotation of the adjustment dial. The axially mounting member and the rotation-direction connecting member may be different functions of the auxiliary device; it will be understood that in some embodiments, the axially mounting member and the rotation-direction connecting member can be formed as a single component.

[0007] The adjustment dial can include one or more axially extending formations protruding from the adjustment dial, and the rotation-direction connecting member can include one or more grooves arranged to engage the one or more formations to non-rotatably connect the sleeve to the adjustment dial.

[0008] The one or more grooves are applied to receive formations of different sizes and / or shapes so that the auxiliary device can be used with various injection devices. Advantageously, since the axially mounting member holds the auxiliary device on the adjustment dial, the grooves do not need to closely adhere to the formations of various adjustment dials and only provide a non-rotatable connection.

[0009] The axial mounting member can be arranged to engage with the distal edge of the adjustment dial. In some examples, the distal edge of the adjustment dial includes the distal edge of one or more formations of the adjustment dial.

[0010] In some examples, the axial mounting member can include a clamp having a plurality of arms. In an initial position, the adjustment dial can move between the arms, and in an engaged position, the arms are pressed against the adjustment dial for axial mounting.

[0011] The plurality of arms may project from a base. For example, the plurality of arms may project from a base ring, but it should be understood that in other embodiments the base can have a different shape, for example a U - shaped or solid shape. In some embodiments, the base is, for example, circular, oval or square.

[0012] The arms extend distally from the base, abut against the inner circumferential wall of the sleeve, and can move from the initial position to the engaged position by proximal movement of the base within the sleeve.

[0013] The distal ends of the arms may be bent inwardly so as to press the adjustment dial in the engaged position.

[0014] In some examples, the axial mounting member can include a snap portion arranged to engage with the edge of the adjustment dial by snap - fitting. The snap portion can be arranged to engage with the distal edge of the adjustment dial. In some examples, the distal edge of the adjustment dial includes the distal edge of one or more formations of the adjustment dial.

[0015] In other examples, the sleeve can include a circumferentially extending groove, and the axial mounting member can include an elastically deformable ring disposed within the groove. In this example, the elastically deformable ring is arranged to deflect outwardly in the engaged position to grip the adjustment dial.

[0016] The deformable ring can also be applied to bite into the adjustment dial at the engagement position. The elastically deformable ring can include one or more blade portions. The deformable ring can include a stepped inner edge that conforms to the forming portion of the adjustment dial.

[0017] The auxiliary device can be a data collection device. In some examples, the data collection device includes a second portion rotatably coupled to the sleeve. At least a portion of the second portion can be axially movable relative to the first portion. The data collection device can further include a sensor device configured to detect rotation of the second portion relative to the sleeve. The data collection device can include a processor configured to determine the amount of drug discharged by the injection device based on the detected movement.

[0018] The data collection device can also include a sensor device configured to detect movement of the second portion relative to the sleeve and / or vibrations and / or sounds caused by the user. The data collection device can include a processor configured to determine the amount of drug discharged by the injection device based on the detected vibrations and / or sounds.

[0019] When worn, the data collection device can monitor the amount and timing of drug delivery from the injection device. For example, the drug amount can be transmitted to, for example, a smartphone and / or displayed on a display of the data collection device. In some embodiments, the axial mounting member can be made of an elastic material and is biased in a direction that allows axial movement of the adjustment dial into the sleeve in the initial position. The axial mounting member may be made of metal.

[0020] In some embodiments, the diameter of the attachment member can be reduced at the engagement position compared to the initial position. The sleeve can have a geometric profile such as an inclined surface of the sleeve wall, a guide portion, a tapered portion, or a thickened portion to bias the attachment member to a smaller diameter at the engagement position compared to the initial position.

[0021] In some embodiments, the auxiliary device can be removed from the injection device, and the attachment member and / or the rotational connection member return from the engagement position to the initial position.

[0022] In some embodiments, the injection device has a distal end opposite the proximal end. In some embodiments, the distal end of the injection device is the end of the injection device where a drug delivery element, such as a needle, is disposed.

[0023] In some embodiments, the sleeve is configured to be non-rotatably connected to the adjustment dial such that rotation of the auxiliary device causes rotation of the adjustment dial. Optionally, the sleeve includes a non-rotatable connection such as a rotational connection member of the inner sleeve to non-rotatably connect the sleeve to the adjustment dial.

[0024] In some embodiments, the adjustment dial of the injection device is for setting a dosage, such as setting the dosage of a drug to be delivered by the injection device.

[0025] In some embodiments, the sleeve includes a cavity for receiving at least a portion of the adjustment dial.

[0026] In some embodiments, the auxiliary device is configured to be positioned on the adjustment dial such that it rotates with the adjustment dial when attached to the injection device.

[0027] In some embodiments, the auxiliary device, when attached to the injection device, is configured to be positioned over the adjustment dial such that it does not contact a portion of the injection device that does not rotate with the adjustment dial, for example a housing to which the adjustment dial is rotatably attached. However, one skilled in the art will understand that in other embodiments the auxiliary device may abut against the non-rotating portion and may move relative to the non-rotating portion when the adjustment dial rotates. For example, the auxiliary device may abut against and move along the outer surface of the housing as the adjustment dial rotates. Alternatively, a first portion of the auxiliary device may be rotatable with the adjustment dial while a second portion of the auxiliary device remains stationary relative to the remainder of the injection device (the adjustment dial rotates relative to the second portion of the auxiliary device), for example, the second portion is rotatably coupled to the first portion of the auxiliary device.

[0028] In one embodiment, an auxiliary device for an injection device including an adjustment dial rotatably attached about an axis at a proximal end, the auxiliary device comprising: a sleeve adapted to be positioned over the adjustment dial when the auxiliary device is attached to the injection device; and an axial attachment member arranged to move from an initial position that allows axial movement of the adjustment dial into the sleeve upon insertion of the adjustment dial into the sleeve to an engagement position that engages the adjustment dial to attach the auxiliary device to the adjustment dial, wherein the axial attachment member includes a clamp having a plurality of arms, in the initial position, the adjustment dial can move between the arms, and in the engagement position, the arms are pressed against the adjustment dial for axial attachment, the arms extend distally from a base, abut against an inner circumferential wall of the sleeve, and move from the initial position to the engagement position by proximal movement of the base within the sleeve, an auxiliary device is provided.

[0029] ​In one embodiment, an auxiliary device for an injection device including an adjustment dial rotatably attached about an axis at a proximal end, the auxiliary device comprising: a sleeve adapted to be positioned over the adjustment dial when the auxiliary device is attached to the injection device; and an axially mounting member arranged to move from an initial position that allows axial movement of the adjustment dial into the sleeve upon insertion of the adjustment dial into the sleeve to an engagement position that engages the adjustment dial to attach the auxiliary device to the adjustment dial, wherein the sleeve includes a circumferentially extending groove, the axially mounting member includes an elastically deformable ring disposed within the groove, and the elastically deformable ring is disposed to deflect outwardly at the engagement position to grip the adjustment dial, an auxiliary device is provided.

[0030] A further aspect of the present disclosure is a method of attaching an auxiliary device to an injection device including an adjustment dial that is axially elongated and rotatably attached at a proximal end, the method comprising: positioning a sleeve of the auxiliary device over the adjustment dial; deflecting an axially mounting member to an engagement position where the axially mounting member engages the adjustment dial for axial attachment of the auxiliary device to the adjustment dial and including.

[0031] In some examples, the axially mounting member can include a clamp having a plurality of arms, wherein in the initial position, the adjustment dial can move between the arms, and in the engagement position, the arms are pressed against the adjustment dial for axial attachment. The plurality of arms may project from a base. For example, the plurality of arms may project from a base ring, but in other embodiments, the base may have a shape other than a ring, for example, it may be U-shaped, or it may be understood that the cross-section may be a solid shape. The base can be, for example, circular, elliptical or square.

[0032] The arm extends distally from the base, abuts against the inner circumferential wall of the sleeve, and can move from the initial position to the engagement position by the proximal movement of the base within the sleeve.

[0033] In other examples, the sleeve can include a circumferentially extending groove, and the axially mounting member can include an elastically deformable ring disposed within the groove. In this example, the elastically deformable ring is disposed to deflect outwardly at the engagement position to grip the adjustment dial.

[0034] Next, examples will be described with reference to the accompanying drawings.

Brief Description of the Drawings

[0035]

Figure 1

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Figure 19B

[0036] This specification discloses an auxiliary device for an injection device. The auxiliary device is attachable to an injection device to perform an auxiliary function. In some examples, the auxiliary device is a data collection device that can be fitted to the injection device, such as a cap, onto a regulation dial at the proximal end of an injection device, such as a pen injector. In particular, the data collection device includes a sleeve that receives the regulation dial. The sleeve defines a cavity into which the regulation dial is pushed to attach the data collection device to the injection device. In various examples described herein, the data collection device includes an axial attachment member that attaches the data collection device to the regulation dial so as to axially hold the data collection device on the injection device. A further rotational connection member can be provided to non-rotatably couple the data collection device to the regulation dial.

[0037] When attached to the regulation dial of the injection device, the data collection device can be operated by the user to cause the operation of the injection device. When attached, the data collection device can monitor the amount and time of drug delivery from the injection device. For example the drug amount can be transmitted to, for example, a smartphone and / or displayed on a display of the data collection device. In some examples, the data collection device, specifically the attachment function, can be configured to be attached to a series of different injection devices, and thus the user's drug treatment can be monitored across multiple devices. Further, this can be achieved without interfering with the normal use of the injection device and without obscuring the dosing window of the injection device.

[0038] Some examples will be described below with reference to an insulin injection device. However, the present disclosure is not limited to such applications and can be equally well utilized for injection devices that release other drugs.

[0039] In addition, some examples will be described below with reference to an auxiliary device that is a data collection device. However, the present disclosure is not limited to data collection devices, and the auxiliary device may equally well be different types of auxiliary devices for injection devices. For example, the auxiliary device may be attached to the injection device and perform one or more functions to automate the injection device.

[0040] 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.

[0041] The injection device 1 of Figure 1 is a disposable pre-filled injection pen that includes a housing 2 and houses an insulin container 3 to which a needle 4 can be attached. The needle 4 is protected by either an inner needle cap 5 and an outer needle cap 6 or an alternative cap 7. The insulin dose to be delivered from the injection device 1 can be programmed or "dialed in" by turning a dosing dial 8, at which time the currently programmed dose is displayed, for example, in multiple units via a dosing window 9. For example, if the injection device 1 is configured to administer human insulin, the dose is displayed in so-called international units (IU), and 1 IU is biologically equivalent to approximately 45.5 micrograms (1 / 22 mg) of pure crystalline insulin. Other units can also be used in injection devices that deliver analog insulin or other drugs. Note that the selected dose can be displayed equally well in a form different from that shown in the dosing window 9 of Figure 1.

[0042] As shown herein, the distal end D of the injection device 1 is the end at which the needle 4 of the injection device 1 is located. The proximal end P of the injection device 1 is the opposite end opposite the needle 4 of the injection device 1.

[0043] The adjustment dial 8 is arranged at the proximal end P of the injection device 1, and the needle 4 is arranged at the distal end D of the injection device 1. The injection device 1 is elongated. In this example, the housing 2 is cylindrical, but the housing 2, and more generally the injection device 1, may have other elongated shapes. The adjustment dial 8 is rotatable around the axis of the injection device 1. The elongated housing 2 of the injection device 1 extends axially.

[0044] The dosage window 9 can be in the form of an aperture in the housing 2. Through the dosage window 9, the user can see a limited part of the digital sleeve 10 configured to move as the adjustment dial 8 is turned, thus providing a visual indication of the currently programmed dosage. When the adjustment dial 8 is turned during programming, it rotates on a helical path relative to the housing 2.

[0045] In this example, the adjustment dial 8 includes one or more formations 11a, 11b, 11c to facilitate gripping of the adjustment dial 8 when no auxiliary device is used. The formations 11a, 11b, 11c will be described in more detail below in this specification with reference to FIGS. 4A and 4B.

[0046] The injection device 1 can be configured such that mechanical click sounds are generated when the adjustment dial 8 is turned, providing acoustic feedback to the user. The digital sleeve 10 interacts mechanically with the piston within the insulin container 3. When the needle 4 is inserted into the patient's skin portion and the injection button 12 is pressed, the insulin dosage displayed in the display window 9 will be released from the injection device 1. Most of the dosage is actually injected into the patient's body while the needle 4 of the injection device 1 is within the skin portion after the injection button 12 is pressed. Mechanical click sounds may also be generated by the release of the insulin dosage, but this click sound is different from the sound generated when using the adjustment dial 8.

[0047] In this embodiment, during the delivery of the insulin dose, the adjustment dial 8 moves axially, i.e., without rotating, towards its initial position, during which the numeric sleeve 10 rotates back to its initial position, displaying, for example, a dose of zero units.

[0048] The injection device 1 can be used for several injection procedures until the insulin container 3 is empty or the expiration date of the drug in the injection device 1 (e.g., 28 days from the first use) is reached.

[0049] 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 3 and the needle 4 by selecting, for example, 2 units of insulin and pressing the injection button 12 while holding the injection device 1 with the needle 4 facing upward. For the sake of brevity of presentation, hereinafter it is assumed that the discharge amount substantially corresponds to the injection dose, and thus, for example, the amount of drug discharged from the injection device 1 is equal to the dose received by the user. Nevertheless, it may still be necessary to take into account the difference (e.g., loss) between the discharge amount and the injection dose.

[0050] Figure 2 is a perspective view of the proximal end P of the injection device 1 when the data collection device 20 is attached. The data collection device 20 includes a housing 21 and an end plate 22 including an optional display 22a. The data collection device 20 can take one of several different forms as described below and shown in the drawings. The data collection device 20 can be used with various injection devices 1 having different adjustment dials 8 as further described hereinbelow.

[0051] As shown in Figure 2, the data collection device 20 covers the adjustment dial 8 (see Figure 1) at its proximal end when attached to the injection device 1. As described above, when the data collection device 20 is rotated to use the injection device 1, the adjustment dial 8 (see Figure 1) rotates as described above.

[0052] Figure 3 is a cross-sectional view of an example of the data collection device 20 when attached to the injection device 1. The data collection device 20 includes a housing 21 that includes a sleeve 23 disposed on the adjustment dial 8. The data collection device 20 is attached to the adjustment dial 8 of the injection device 1 via the sleeve 23. The sleeve 23 defines a cavity 24 in which the adjustment dial 8 is disposed when the data collection device 20 is attached to the injection device 1. The distal end D of the cavity 24 is open, and the adjustment dial 8 is inserted through this open distal end.

[0053] It will be appreciated that Figure 3 is a simplified illustration of the data collection device 20. In various examples, the data collection device 20 can include additional members. For example, the data collection device can include a second member movably coupled to the sleeve 23. For example, the second member can move rotationally or axially relative to the sleeve 23. The data collection device 20 can include a button. The button can be depressed relative to other members of the data collection device 20. The button can include a spring. However, such a button is not essential. For example, the data collection device 20 can determine the use of the injection device 1 when a sensor detects rotation of the adjustment dial. In one embodiment, the data collection device 20 can have a motion sensor, such as an accelerometer, that detects the use of the injection device 1, for example, by detecting axial and / or rotational movement of the adjustment dial. In other embodiments, the button and the motion sensor are omitted, and instead the data collection device 20 is always powered on.

[0054] In addition, the data collection device 20 can include various electronic components. For example, the data collection device 20 can include one or more of a power source, such as a battery, a switch, a processor, a connector, a transmitter, and / or a receiver.

[0055] In one example, the data collection device 20 includes a switch disposed to detect axial movement of a part of the data collection device 20, such as a button. In this way, the data collection device 20 can detect the use of the injection device 1.

[0056] The electronic component can monitor the use of the injection device. For example, the data collection device 20 can record, transmit, or display information regarding the use of the injection device 1, such as dose size, dose time, number of doses, etc.

[0057] In the arrangement, the shape of the sleeve 23 is such that the engagement between the sleeve 23 and the adjustment dial 8 is substantially uniform over the entire axial length of the adjustment dial 8. This helps to ensure the correct axial orientation of the data collection device 20 with respect to the injection device 1. This axial orientation is provided because if the orientation is incorrect, the shape of the components results in a radial corrective force being applied between them when the adjustment dial 8 and the sleeve 23 are fitted together. The correct axial alignment is useful because it transmits the rotational force from the sleeve 23 to the adjustment dial 8 better and also provides better feedback to the user during the execution of dose delivery. Further, this generally improves the user experience.

[0058] To set the dosage of the drug to be administered, the user can grip and rotate the data collection device 20, causing the adjustment dial 8 of the injection device 1 to rotate and the dosage to be programmed.

[0059] Different injection devices similar to SoloStar (registered trademark), or variations of SoloStar (registered trademark), can have adjustment dials 8 of different shapes. For example, FIG. 4A shows a first adjustment dial 8a, and FIG. 4B shows another adjustment dial 8b. Exemplary adjustment dials 8a, 8b each include a dial member 13 and an injection button 12. The dial member 13 has a somewhat conical form that tapers towards the injection button 12 at the proximal end.

[0060] As shown in the figures, formation parts 11a, 11b, 11c, 11d, 11e, 11f are formed around the circumferential surface of the dial member 13. The formation parts 11a, 11b, 11c, 11d, 11e, 11f protrude from the circumferential surface of the dial member 13. The formation parts 11a, 11b, 11c, 11d, 11e, 11f are spaced around the dial member 13 and extend axially in the direction.

[0061] In the exemplary adjustment dial 8a of FIG. 4A, the formation parts 11a, 11b, 11c have a generally rectangular shape with rounded edges and have tapered upper parts 14a, 14b, 14c that taper towards the circumferential surface of the dial member 13.

[0062] In the exemplary adjustment dial 8b of FIG. 4B, the formation parts 11d, 11e, 11f have a generally triangular shape and have rounded upper parts 15a, 15b, 15c.

[0063] The formation parts 11a, 11b, 11c of the adjustment dial 8a are different from the formation parts 11d, 11e, 11f of the adjustment dial 8b, but the dial member 13 and the button 12 are substantially the same.

[0064] In some examples, the adjustment dial 8 can include a single formation part that is larger than other formation parts. For example, the larger formation part can serve as an indicator to the user of the rotational position of the adjustment dial 8.

[0065] In one example, the adjustment dial 8a of FIG. 4A is used for the SoloStar® insulin pen injection device 1 having a first type of drug, and the adjustment dial 8b of FIG. 4B is used for the SoloStar® insulin pen injection device 1 having a second type of drug.

[0066] Adjustment dials 8a, 8b of different shapes can also be used for different injection devices 1, for example, injection devices 1 containing different drugs. Alternatively, the forming parts 11 of the adjustment dials 8a, 8b in different factories may be different. It is advantageous for the data collection device 20 to be adaptable to various types of adjustment dials 8a, 8b so that it can be used with various injection devices 1. The examples of the data collection device 20 described below in this specification can be attached to various adjustment dials 8a, 8b while taking into account the shape variations of the forming parts 11a, 11b, 11c, 11d, 11e, 11f in the adjustment dials 8a, 8b.

[0067] FIG. 5 shows an example of the data collection device 20 applied to fit either of the adjustment dials 8a, 8b of FIGS. 4A and 4B, as well as other similar adjustment dials of the same or similar injection devices 1.

[0068] The data collection device 20 of FIG. 5 includes a sleeve 23 that defines a cavity 24 for receiving an adjustment dial 8 that extends to the distal end of the data collection device 20. The sleeve 23 includes an inner circumferential wall 25 facing the cavity 24. The inner circumferential wall 25 is applied to substantially conform to the outer profiles of various adjustment dials 8a, 8b so that the sleeve 23 fits over the adjustment dials 8a, 8b.

[0069] Specifically, the inner circumferential wall 25 is conical and conforms to the outer shape of the adjustment dial 8. The inner circumferential wall 25 further includes a plurality of grooves 26. The grooves 26 are sized to accommodate any of the forming parts 11a, 11b, 11c, 11d, 11e, 11f in any of the various adjustment dials, such as the adjustment dials 8a, 8b of FIGS. 4A and 4B.

[0070] As shown in FIG. 5, the inner circumferential wall further includes a wider groove 27 that is applied to receive a larger formed portion as described with reference to FIGS. 4A and 4B. The wider groove 27 can include a funnel-shaped opening 28. When the data collection device 20 is pushed onto the adjustment dials 8a, 8b, the funnel-shaped opening 28 allows the data collection device 20 to rotate and function to align the rotational position with respect to the formed portions 11a, 11b, 11c, 11d, 11e, 11f of the adjustment dials 8a, 8b.

[0071] As shown in FIGS. 5 and 6A, the data collection device 20 further includes a deformable portion 29 that is positioned to define a part of the inner circumferential wall 25. The deformable portion 29 extends circumferentially around the cavity 24 at the proximal end of the cavity 24. The deformable portion 29 is positioned to grip the formed portions 11a, 11b, 11c, 11d, 11e, 11f to non-rotatably couple the data collection device 20 to the adjustment dial 8.

[0072] FIG. 6A shows the data collection device 20 of FIG. 5 after attachment to the adjustment dial 8. As shown, the adjustment dial 8 is received in the cavity 24 of the sleeve 23, and the inner circumferential wall 25 substantially conforms to the outer shape of the adjustment dial 8. Also as shown, the tops of the formed portions 11a, 11b of the adjustment dial 8 engage the deformable portion 29 of the inner circumferential wall 25. Specifically, the proximal ends of the formed portions 11a, 11b contact the deformable portion 29.

[0073] As shown in FIG. 6B, which is an enlarged view of a part of FIG. 6A, the inner circumferential wall 25 of the sleeve 23 has an axially mounting member that engages the distal edge 30 of the adjustment dial 8 in a snap-fit arrangement.

[0074] Specifically, the inner circumferential wall 25 of the data collection device 20 includes a snap portion 31 located at the distal end of the cavity 24. This snap portion 31 is arranged to snap onto the distal edge 30 of the adjustment dial 8 when the data collection device 20 is attached to the injection device 1.

[0075] In some examples, as shown in FIGS. 6A and 6B, the distal edge 30 of the adjustment dial 8 includes a cutback portion 49 with which the snap portion 31 engages. In other examples, the distal edge 30 of the adjustment dial 8 can be rounded or angled to engage the snap portion 31.

[0076] The cutback portion 49, rounded or angled distal edge 30 can be formed on the main dial member (13, see FIGS. 4A and 4B) of the adjustment dial 8. Alternatively, the cutback portion 49, rounded or angled distal edge 30 can be formed on one or more of the formation parts 11a, 11b, 11c, 11d, 11e, 11f of the adjustment dial 8.

[0077] In one example, the data collection device 20 has one snap portion 31 for each of the formation parts 11a, 11b, 11c, 11d, 11e, 11f of the adjustment dial 8, as shown in FIGS. 5 and 7. In other examples, the data collection device 20 has two or more snap portions 31, which are arranged to engage corresponding distal edges 30 of the formation parts 11a, 11b, 11c, 11d, 11e, 11f of the adjustment dial 8. In other examples, there is one snap portion 31 for each of the formation parts 11a, 11b, 11c, 11d, 11e, 11f.

[0078] The snap fit arrangement provided by one or more snap portions 31 of the data collection device 20 provides for axial attachment of the data collection device 20 to the injection device 1, specifically to the adjustment dial 8. That is, the snap fit arrangement axially holds the data collection device 20 on the adjustment dial 8. The snap portion 31 can be considered an axial attachment member.

[0079] To attach the data collection device 20 to the adjustment dial 8, align the groove 26 with the forming portions 11a, 11b, 11c, 11d, 11e, 11f of the adjustment dial 8 and push the data collection device 20 onto the injection device 1. When pushing the data collection device 20 onto the adjustment dial 8, the snap portion 31 engages with the forming portions 11a, 11b, 11c, 11d, 11e, 11f of the adjustment dial 8 and deflects outward as the adjustment dial 8 moves within the cavity 24. When the adjustment dial 8 is properly inserted into the cavity 24, the snap portion 31 crosses the distal edge 30 and snaps under the distal edge 30 of the adjustment dial 8 to engage the adjustment dial 8. Thus, the data collection device 20 is axially attached to the adjustment dial 8.

[0080] As described above, at this position, the proximal ends of the forming portions 11a, 11b, 11c, 11d, 11e, 11f of the adjustment dial 8 engage the deformable portion 29. The engagement between the forming portions 11a, 11b, 11c, 11d, 11e, 11f and the groove 26 and / or the engagement between the forming portions 11a, 11b, 11c, 11d, 11e, 11f and the deformable portion 29 result in a non-rotatable connection of the data collection device 20 to the adjustment dial 8.

[0081] In this way, the data collection device 20 can be axially attached to the adjustment dial 8 and non-rotatably connected. Advantageously, the groove 26 and the deformable portion 29 are not required to axially attach the data collection device 20 to the adjustment dial 8, as their function is provided by the snap-fit arrangement. Thus, the groove 26 and the deformable portion 29 can be applied to fit a wide variety of forming portions 11a, 11b, 11c, 11d, 11e, 11f since these functions only result in a non-rotatable connection. However, it will be understood that the deformable portion 29 can also be an axial mounting member if desired.

[0082] As will be described below in this specification, the deformable portion 29 may be diverse so as to engage well with the various formed portions 11a, 11b, 11c, 11d, 11e, 11f of the adjustment dial 8.

[0083] FIG. 7 is a cross-sectional view of the cavity 24 of the data collection device 20. As shown, the inner circumferential wall 25 of the sleeve 23 includes a plurality of grooves 26 each having a snap portion 31 for the axial attachment of the data collection device 20 to the adjustment dial 8 as described above.

[0084] Also as shown in FIG. 7, the deformable portion 29 is integrally formed with the sleeve 23. For example, the sleeve 23 is formed from a rigid plastic material such as a thermoplastic material, and the deformable portion 29 is also formed simultaneously. Such a dual-moulding process can be realized using, for example, injection moulding. Alternatively, the deformable portion 29 may be adhered or welded to the sleeve 23. In other examples, the deformable portion 29 may be captured between two members of the data collection device 20 and held in place by attaching those two members to each other.

[0085] The deformable portion 29 can be made of a flexible elastic material, such as rubber.

[0086] As shown, the deformable portion 29 is disposed at the proximal end P of the cavity 24 so as to engage with the proximal ends of the formed portions 11a, 11b, 11c, 11d, 11e, 11f of the adjustment dial 8 as described above.

[0087] The deformable portion 29 includes a ring extending around the inner circumferential wall 25. The deformable portion 29 is provided with ribs 32 where they coincide with the grooves 26. In the example of FIG. 7, five ribs 32 are provided for each groove 26. The ribs 32 extend axially. The ribs 32, when attaching the data collection device 20 to the adjustment dial 8, the formed portions 11a, 11b, 11c, 11d 、11e, 11f's proximal ends are easily deformed to provide a non-rotatable connection between the data collection device 20 and the adjustment dial 8.

[0088] Figures 8A - 8C show various alternative forms of the deformable portion 29 of the data collection device 20.

[0089] In Figure 8A, the deformable portion 29 is as described with reference to Figure 7, but the rib 32 that coincides with the groove 26 is not formed. In this example, the material of the deformable portion 29 can have higher malleability (i.e., be more flexible) so that the data collection device 20 can be attached to the adjustment dial 8 without applying excessive force.

[0090] In Figure 8B, the deformable portion 29 is axially longer than in Figure 8A. The deformable portion 29 in this example further extends distally towards the distal end of the sleeve 23. This increase in length results in a greater interaction between the forming parts 11a, 11b, 11c, 11d, 11e, 11f and the deformable portion 29, resulting in a stronger non-rotatable connection.

[0091] In Figure 8C, the deformable portion 29 is as described with reference to Figure 7, but the rib 32 that coincides with the groove 26 is wider circumferentially. The wider rib 32 requires more force to deform to enable the connection of the data collection device 20 to the adjustment dial 8, but it can provide a stronger non-rotatable connection between the data collection device 20 and the adjustment dial 8.

[0092] Figures 9A and 9B show a further example of the data collection device 20 attached to the adjustment dial 8 of the injection device 1. In this example, the sleeve 23 is axially attached to the adjustment dial 8 by snap-fit attachment.

[0093] In this example, the inner circumferential wall 25 of the sleeve 23 is formed from a plurality of arms 33. Between the arms 33 of the inner circumferential wall 25, slots 34 are provided that extend from the proximal end top of the cavity 24 towards the distal end that opens.

[0094] Each arm 33 has on its inner surface recesses 35 that are adapted to receive the forming parts 11a, 11b, 11c, 11d, 11e, 11f of the adjustment dial 8. The snap portions 31 are provided at the distal ends of the arms 33 at the same positions as in the examples of FIGS. 5 to 8C. These snap portions 31 are arranged to engage, for example, the distal edge 30 of the adjustment dial 8, which is the distal end of the forming parts 11a, 11b, 11c, 11d, 11e, 11f, as described with reference to FIGS. 6A and 6B.

[0095] As shown in FIGS. 9A and 9B, proximal snap portions 36 are provided at the proximal ends of the recesses 35. The proximal snap portions 36 are positioned to engage the proximal ends of the forming parts 11a, 11b, 11c, 11d, 11e, 11f of the adjustment dial 8.

[0096] The proximal ends of the forming parts 11a, 11b, 11c, 11d, 11e, 11f may be rounded, chamfered, or have their proximal ends cut back so that the proximal snap portions 36 can engage the forming parts 11a, 11b, 11c, 11d, 11e, 11f.

[0097] To attach the data collection device 20 to the adjustment dial 8, the data collection device 20 is pushed onto the adjustment dial 8. When the data collection device 20 is axially pushed, the adjustment dial 8 deflects the snap portions 31. When the adjustment dial 8 engages the proximal snap portions 36, the arms 33 are deflected outwards. When the adjustment dial 8 is fully inserted, the snap portions 31 engage the distal edge 30 of the adjustment dial 8 as described above, and the proximal snap portions 3 6 engages with the proximal ends of the forming portions 11a, 11b, 11c, 11d, 11e, 11f. At this position, the snap portions 31, 36 axially attach the data collection device 20 to the adjustment dial 8. The snap portions 31, 36 can be considered as axial attachment members. In addition, the forming portions 11a, 11b, 11c, 11d, 11e, 11f are disposed in the recess 35, whereby the data collection device 20 is non-rotatably connected to the adjustment dial 8.

[0098] The slots 34 between the arms 33 allow for outward deflection of the arms 33, movement of the proximal snap portion 36 to the engagement position, and movement of the forming portions 11a, 11b, 11c, 11d, 11e, 11f into the recess 35.

[0099] In the examples of FIGS. 5 to 9B, the snap portions 31, 36 are deflected from the initial position to the engagement position as the data collection device 20 is pushed onto the adjustment dial 8.

[0100] FIGS. 10, 11, and 12 show a further example of the data collection device 20 applied to fit the adjustment dial 8, such as the adjustment dials 8a, 8b of FIGS. 4A and 4B, and other similar adjustment dials 8.

[0101] In this example, the data collection device 20 includes a sleeve 23 having a circumferential wall 25 that defines a cavity 24 for receiving the adjustment dial 8. As shown, a gripping member is disposed within the cavity 24. In this example, the gripping member is a clamp 37 that grips the adjustment dial 8 to connect the data collection device 20 to the adjustment dial 8. The clamp 37 has a base ring 38 and a plurality of arms 39, 40 projecting from the base ring 38. The arms 39, 40 are spaced apart from each other. The base ring 38 is disposed proximal to the cavity 24, and the arms 39, 40 extend distally from the base ring 38.

[0102] Arms 39 and 40 are arranged to clamp the adjustment dial 8 as the adjustment dial 8 is pushed into the cavity 24 and the clamp 37 moves axially in the proximal direction. In this embodiment, the clamp 37 can be considered as an axial mounting member.

[0103] The clamp 37 includes long arms 39 and short arms 40 that are alternately arranged around it. The long arm 39 is arranged to be placed between the formed parts 11a, 11b, 11c, 11d, 11e, 11f of the adjustment dial 8 when the data collection device 20 is attached to the adjustment dial 8. The short arm 40 is arranged to be on the formed parts 11a, 11b, 11c, 11d, 11e, 11f of the adjustment dial 8 when the data collection device 20 is attached to the adjustment dial 8.

[0104] Also as shown, the circumferential wall 25 includes a plurality of grooves 41 arranged to receive the arms 39, 40 of the clamp 37. The grooves 41 corresponding to the short arms 40 are further applied to receive the formed parts 11a, 11b, 11c, 11d, 11e, 11f of the adjustment dial 8.

[0105] As shown, the distal end 42 of the long arm 39 is bent inward.

[0106] The inner circumferential wall 25 of the sleeve 23 includes one or more protrusions 43 at the distal end of the cavity 24. The protrusion 43 may be a circumferential ridge extending around the inner circumferential wall 25 of the sleeve 23, or the inner circumferential wall 25 may have a plurality of separate protrusions 43 that are aligned with the long arm 39.

[0107] Figures 13A - 13C show the data collection device 20 of Figures 10 - 12 attached to the adjustment dial 8 The attaching process is shown. As shown in FIG. 13A, the clamp 37 is in its initial position, partially received in the cavity 24, and the arms 39, 40 are in an unbiased state and are open wide enough to receive the adjustment dial 8 between the arms 39, 40 as shown in FIG. 13B. As the adjustment dial 8 is pushed into the cavity 24 as shown in FIG. 13B, the inner shape of the cavity 24 causes the arms 39, 40 to deflect inwardly to an engaged position and grip the adjustment dial 8. At the position shown in FIG. 13C, the adjustment dial 8 is fully inserted into the cavity 24 and the arms 39, 40 grip the adjustment dial 8.

[0108] The protrusion 43 of the inner circumferential wall 25 interacts with the inwardly deflected end 42 of the long arm 39 so as to hold the clamp 37 and the adjustment dial 8 within the cavity 24. Specifically, as the adjustment dial 8 is pushed into the cavity 24, the long arm 39 becomes somewhat straight at the deflected end 42, allowing the curved portion of each long arm 39 to move proximally over the protrusion 43. The long arm 39 returns after passing over the protrusion 43, and the clamp 37 is effectively locked in the cavity.

[0109] At the position of FIG. 13C, the formations 11a, 11b, 11c, 11d, 11e, 11f of the adjustment dial 8 and the short arm 40 of the clamp 37 are within the groove 41. The short arm 40 can be arranged to deflect and exert an inward gripping force on the formations 11a, 11b, 11c, 11d, 11e, 11f as the adjustment dial 8 is pushed into the cavity 24. Similarly, at the position of FIG. 13C, the long arm 39 of the clamp 37 is somewhat deflected, thereby exerting an inward gripping force on the adjustment dial 8. In some examples, the deflected end 42 of the long arm 39 can extend under the distal end 30 of the adjustment dial 8.

[0110] In this way, the data collection device 20 is axially attached to the adjustment dial 8 by the arms 39, 40 of the clamp 37. In addition, a groove 41 for receiving the forming parts 11a, 11b, 11c, 11d, 11e, 11f non-rotatably connects the data collection device 20 to the adjustment dial 8.

[0111] Figures 14, 15 and 16 show a further example of the data collection device 20 applied to fit either of the adjustment dials 8a, 8b of FIGS. 4A and 4B, as well as other similar adjustment dials 8.

[0112] In this example, the data collection device 20 includes a sleeve 23 having an inner circumferential wall 25 that defines a cavity 24 for receiving the adjustment dial 8. In this example, the inner circumferential wall 25 has a circumferentially extending groove 44. The groove 44 is arranged to receive a mounting ring 45 shown in FIG. 15 and visible at a predetermined position in FIG. 16.

[0113] As shown in FIG. 16, the mounting ring 45 is arranged in the groove 44 such that its inner edge 46 extends from the groove 44 into the cavity 24. In this way, the inner edge 46 engages the adjustment dial 8 when the adjustment dial 8 is pushed into the cavity 24.

[0114] The mounting ring 45 includes an elastic material and includes a slit 47. The mounting ring 45 extends into the cavity 24 in its initial position and deforms outwardly under the force of the adjustment dial 8 as the adjustment dial 8 is pushed into the cavity 24. Accordingly, the elasticity of the mounting ring 45 causes the inner edge 46 to grip the adjustment dial 8, and the data collection device 20 is axially attached to the adjustment dial 8. In this position, the mounting ring 45 is in an engaged position. The mounting ring 45 can be considered an axial mounting member in this example.

[0115] The elasticity of the mounting ring 45 and / or the design of the inner edge 46 cause the mounting ring 45 to It can be such that it holds the loop 8 or bites into the adjustment dial 8. Since the outermost functions of the adjustment dial are the forming parts 11a, 11b, 11c, 11d, 11e, 11f, the mounting ring 45 will hold or bite into them. It will be understood that the mounting ring can further provide the features of a rotational connection member.

[0116] As shown in FIG. 14, the inner circumferential wall 25 of the sleeve 23 further includes a groove 26 similar to that described with reference to FIG. 5, which provides a non-rotatable connection between the data collection device 20 receiving the forming parts 11a, 11b, 11c, 11d, 11e, 11f of the adjustment dial 8 and the adjustment dial 8. Optionally, a wider groove 27 including a funnel-shaped mouth portion 28 may be provided to accommodate larger forming parts.

[0117] As shown in FIG. 17A, the inner edge 46' of the mounting ring 45' may be at a right angle, and the elastic force of the mounting ring 45' presses the adjustment dial 8' to provide an axial attachment. Alternatively, as shown in FIG. 17B, the inner edge 46' of the mounting ring 45' may be inclined to provide a cutting edge that bites into the adjustment dial 8' to provide an axial attachment.

[0118] As shown in FIG. 18, the inner edge 46 of the mounting ring 45 may be stepped with a recess 47 provided to accommodate the forming parts 11a, 11b, 11c, 11d, 11e, 11f of the adjustment dial 8. In this way, the mounting ring 45 can hold or bite into the forming parts 11a, 11b, 11c, 11d, 11e, 11f and the main part of the adjustment dial 8 between the forming parts 11a, 11b, 11c, 11d, 11e, 11f.

[0119] As shown in FIGS. 19A and 19B, the inner edge 46 of the mounting ring 45 may be provided with a serrated portion 48 that increases the gripping or biting force provided by the elastic force of the mounting ring 45 that presses the adjustment dial 8. As shown in FIG. 19A, the serrated portion 48 can be provided on the stepped mounting ring 45 as shown in FIG. 18. Alternatively, the serrated portion 48 may be provided on a circular mounting ring 45 such as that shown in FIG. 15.

[0120] Alternatively, as shown in FIG. 19B, the serrated portions 48 may be arranged as a spaced group around the mounting ring 45.

[0121] It will be appreciated that in each of the described examples, any function that can effect axial mounting can be considered an axial mounting member, and any function that can effect a non-rotatable connection can be considered a rotational connection member.

[0122] The axial mounting member prevents disconnection of the data collection device from the adjustment dial, while the rotational connection member allows the data collection device to move in unison with the adjustment dial.

[0123] In each of the described examples, the data collection device 20 is adapted for use with various similar adjustment dials 8 such as the adjustment dials 8a, 8b described with reference to FIGS. 4A and 4B.

[0124] The injection device 1 is configured to inject or infuse a drug into a patient. For example, delivery can be subcutaneous, intramuscular, or intravenous. Delivery may also be needle-free. The injection device 1 can be operated by a patient or a healthcare provider such as a nurse or doctor, and can be one of various types of safety syringes, pen injectors, or auto-injectors. The injection device 1 can include a cartridge-based system and requires piercing a sealed ampoule before use. The volume of the drug delivered by these various devices can range from about 0.5 ml to about 2 ml. The injection device 1 may be a large volume device ("LVD") or a patch pump and is configured to adhere to the patient's skin for a period of time (e.g., about 5, 15, 30, 60, or 120 minutes) and deliver a "large" volume of drug (typically about 2 ml to about 10 ml). In combination with a particular drug, the injection device 1 can also be customized to operate within the required specification range. For example, the injection device 1 can be customized to inject the drug within a range of specific time periods (e.g., about 3 to about 20 seconds for an auto-injector and about 10 minutes to about 60 minutes for an LVD). Other specifications can include specific conditions related to low or minimal discomfort, or human factors, shelf life, expiration date, biocompatibility, environmental considerations, etc. Such variations can occur due to various factors such as the drug's viscosity ranging from about 3 cP to about 50 cP. Thus, the injection device 1 can include a hollow needle in the range of about 25 to about 31 gauge. Common sizes are 27 and 29 gauge.

[0125] The injection device 1 can also include one or more automated functions. For example, one or more of needle insertion, drug injection, and needle withdrawal can be automated. The energy for one or more of the automated steps can be provided by one or more energy sources.

[0126] The energy source can include, for example, mechanical, pneumatic, chemical, or electrical energy. For example, a mechanical energy source can include a spring, lever, elastomer, or other mechanical mechanism for storing or releasing energy. One or more energy sources can be combined within a single device. The device can further include gears, valves, or other mechanisms for converting the energy into movement of one or more components of the device.

[0127] One or more automatic functions of such an injection device 1 can each be activated via an activation mechanism. Such an activation mechanism can include one or more of a button, lever, needle sleeve, or other activation components. Activation of the automatic function can be a process including one step or multiple steps. That is, the user may need to activate one or more activation components so that the automatic function is performed. For example, in a process including one step, the user can press the needle sleeve against their body and push it down to enable injection of the drug to be provided. The injection device 1 may also require activation of multiple steps of the automatic function. For example, the user may need to press a button and retract a needle shield to perform an injection.

[0128] In addition, activation of one automatic function can activate one or more next automatic functions, thereby forming an activation sequence. For example, activation of the first automatic function can activate at least two of needle insertion, drug injection, and needle retraction. The injection device 1 may also require a specific series of steps so that one or more automatic functions are performed. The injection device 1 can also operate by a series of independent steps.

[0129] The injection device 1 can include one or more functions of a safety syringe, a pen injector, or an auto-injector. For example, the injection device 1 can include a mechanical energy source configured to automatically inject a drug (typically found in an auto-injector) and a dose setting mechanism (typically found in a pen injector).

[0130] The injection device 1 may be disposable or reusable.

[0131] The injection device 1 can provide a fixed dose or a user-settable dose.

[0132] The drug or medicament can be contained in a primary package or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other vessel configured to provide a chamber suitable for containing one or more pharmaceutically active ingredients (e.g., short-term or long-term containment). For example, in some cases, the chamber can be designed to contain the drug for at least one day (e.g., from one day to at least 30 days).

[0133] In some cases, the chamber can be designed to store the drug for about 1 month to about 2 years. Storage can be carried out at room temperature (e.g., about 20°C) or refrigerated temperature (e.g., about -4°C to about 4°C). In some cases, the drug container can be or include a dual-chamber cartridge configured to separately store one by one two or more components of the drug formulation (e.g., a drug and a diluent, or two different types of drugs) in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components of the drug or agent before and / or during dosing to a human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and allow mixing of the two components by the user before dosing if desired. Alternatively or additionally, the two chambers can be configured to allow mixing during dosing of the components to a human or animal body.

[0134] The drug delivery devices and drugs described herein can be used for the treatment and / or prevention of many different types of disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes such as diabetic retinopathy, thromboembolic disorders such as deep vein thrombosis or pulmonary embolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis.

[0135] The terms "drug" or "medication" are used interchangeably herein and describe a pharmaceutical formulation that includes one or more active pharmaceutical ingredients or their pharmaceutically acceptable salts or solvates, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API") is, in the broadest sense, a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medication is used to treat, cure, prevent, or diagnose a disease or, alternatively, to improve physical or mental well-being. A drug or medication can be used for a limited duration or, in the case of a chronic disorder, periodically.

[0136] As described below, a drug or medication can include at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs can include small molecules having a molecular weight of 500 Da or less, polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0137] A drug or medication can be contained in a primary package or "drug container" that is adapted for use in a drug delivery device. The drug container is configured, for example, to provide a chamber suitable for containing one or more drugs (e.g., for short-term or long-term storage). It can be a cartridge, syringe, reservoir, or other rigid or flexible vessel. For example, in some cases, the chamber can be designed to store the drug for at least 1 day (e.g., 1 day to at least 30 days). In some cases, the chamber can be designed to store the drug for about 1 month to about 2 years. Storage can be carried out at room temperature (e.g., about 20 °C) or refrigerated temperature (e.g., about -4 °C to about 4 °C). In some cases, the drug container can be a dual-chamber cartridge configured to separately store one by one two or more components of the pharmaceutical preparation to be administered (e.g., API and diluent, or two different drugs) in each chamber, or can include it. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components before and / or during dosing to a human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and to allow mixing of the two components by the user before dosing if desired. Alternatively or additionally, the two chambers can be configured to allow mixing during dosing of the components to a human or animal body.

[0138] The drugs or agents included in the drug delivery device described herein can be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes such as diabetic retinopathy, thromboembolic disorders such as deep vein thrombosis or pulmonary embolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those described in handbooks such as the Rote Liste 2014 (e.g., but not limited to main group 12 (antidiabetic agents) or 86 (oncological agents)) or the 15th edition of the Merck Index.

[0139] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin, such as human insulin, or human insulin analogs or derivatives, glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, their analogs or derivatives, dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof, or mixtures of any of them. As used herein, the terms "analog" and "derivative" refer to polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, such as the structure of human insulin, by deletion and / or exchange of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues can be any of the codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, for example, the molecular structure of human insulin in which one or more organic substituents (such as fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide are deleted and / or replaced by other amino acids including non-codable amino acids or amino acids are added including those non-codable to the naturally occurring peptide.

[0140] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); Human insulin in which the proline at position B28 may be replaced by Asp, Lys, Leu, Val or Ala and the Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28~B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0141] Examples of insulin derivatives include, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir (registered trademark)); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba (registered trademark)); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0142] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39-amino acid peptide produced by the salivary gland of the Gila monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), r exendin-4, CJC-1134-PC, PB-1023, TTP-054, langlenatide / HM-11260C, CM-3, GLP-1 eligon, ORMD-0901, NN-9924, NN-9926, NN-9927, nodexen, viadorl-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, exenatide-XTEN, and glucagon-Xten.

[0143] Examples of oligonucleotides include, for example, the cholesterol-lowering antisense therapeutic agent mipomersen sodium (Kynamro®) for the treatment of familial hypercholesterolemia.

[0144] Examples of DPP4 inhibitors include vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0145] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, for example, gonadotropins (folitropin, lutropin, chorionic gonadotropin, menotropin), somatropin (Somatropine) (Somatropin), desmopressin, terlipressin, gonadorelin, tryptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0146] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or their derivatives, or sulfated polysaccharides such as the polysaccharides described above in poly-sulfated form, and / or their pharmaceutically acceptable salts. An example of a pharmaceutically acceptable salt of poly-sulfated low molecular weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives are hylan G-F20 (Synvisc (registered trademark)), sodium hyaluronate.

[0147] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab’)2 fragments that retain the ability to bind to an antigen. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., murine) antibodies, or single-chain antibodies. In some embodiments, the antibody has effector functions and is capable of fixing complement. In some embodiments, the antibody has reduced or no ability to bind to an Fc receptor. For example, the antibody can be an isotype or subtype, antibody fragment or mutant that does not assist in binding to an Fc receptor, for example, having a mutation or deletion in the Fc receptor-binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable domain antibody-like binding proteins having a crossover binding region orientation (CODV).

[0148] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include a full-length antibody polypeptide but still includes at least a portion of the full-length antibody polypeptide that is capable of binding to an antigen. An antibody fragment can include a cleaved portion of the full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments useful in the present disclosure include, for example, Fab fragments, F(ab’)2 fragments, scFv (single-chain Fv) fragments, linear antibodies, single-specific or multispecific antibody fragments, such as bispecific, trispecific, tetra-specific, and multispecific antibodies (e.g., diabodies, tribodies, tetrabodies), monovalent or polyvalent antibody fragments, such as divalent, trivalent, tetravalent, and polyvalent antibodies, minibodies, chelated recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0149] The term "complementary determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both the heavy and light chain polypeptides that primarily play a role in mediating specific antigen recognition. The term "framework region" refers to the amino acid sequences within the variable regions of both the heavy and light chain polypeptides that are not CDR sequences and primarily play a role in maintaining the proper arrangement of the CDR sequences to enable antigen binding. The framework region itself is typically not directly involved in antigen binding, but as is known in the art, certain residues within the framework region of a particular antibody can be directly involved in antigen binding or can affect the ability of one or more amino acids within the CDR to interact with the antigen.

[0150] Examples of antibodies are anti-PCSK-9 mAbs (e.g., alirocumab), anti-IL-6 mAbs (e.g., sarilumab), and anti-IL-4 mAbs (e.g., dupilumab).

[0151] Any pharmaceutically acceptable salts of the APIs described herein are contemplated for use in a drug or agent in a drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and basic salts.

[0152] Modifications (additions and / or deletions) to the various components of the APIs, formulas, devices, methods, systems, and embodiments described herein can be made without departing from the full scope and spirit of the disclosure, and it will be understood by those skilled in the art that the disclosure encompasses all such modifications, and all equivalents thereof.

Claims

1. An auxiliary device for an injection device including an adjustment dial rotatably mounted about an axis at a proximal end, the auxiliary device comprising: a sleeve adapted to be applied over the adjustment dial when the auxiliary device is attached to the injection device; an axially mounting member arranged to move from an initial position allowing axial movement of the adjustment dial into the sleeve by insertion of the adjustment dial into the sleeve to an engagement position engaging the adjustment dial to attach the auxiliary device to the adjustment dial; wherein the sleeve includes a circumferentially extending groove, the axially mounting member includes an elastically deformable ring disposed within the groove, and the elastically deformable ring is disposed to deflect outwardly in the engagement position to grip the adjustment dial.

2. The auxiliary device according to claim 1, wherein the axially mounting member is adapted to engage the adjustment dial such that axial movement of the adjustment dial relative to the sleeve is restricted in the engagement position.

3. The auxiliary device according to claim 1 or 2, further comprising a rotation direction connecting member arranged to non-rotatably connect the sleeve to the adjustment dial such that rotation of the auxiliary device causes rotation of the adjustment dial.

4. The auxiliary device according to claim 3, wherein the axially mounting member and the rotation direction connecting member are a single component of the auxiliary device.

5. The auxiliary device according to claim 3 or 4, wherein the adjustment dial includes one or more axially extending formations projecting from the adjustment dial, and the rotation direction connecting member includes one or more grooves arranged to engage the one or more formations to non-rotatably connect the sleeve to the adjustment dial.

6. The auxiliary device according to claim 5, wherein the one or more formations include a plurality of formations having different sizes.

7. The auxiliary device according to claim 5, wherein the one or more grooves rotate the sleeve to align with the one or more formations projecting from the adjustment dial.

8. The auxiliary device according to claim 5, wherein the one or more grooves are adapted to receive formations having different sizes and / or shapes such that the auxiliary device can be used with various injection devices.

9. ​ The axial mounting member is the auxiliary device according to claim 1 or 2, which is arranged to engage with the distal edge of the adjustment dial.

10. The deformable ring is the auxiliary device according to claim 1, which is applied to bite into the adjustment dial at the engagement position.

11. The elastically deformable ring is the auxiliary device according to claim 10, which includes one or more blade portions.

12. The diameter of the axial mounting member decreases at the engagement position compared to the initial position, which is the auxiliary device according to claim 1 or 2.

13. The axial mounting member is made of an elastic material and is biased in a direction that allows axial movement of the adjustment dial into the sleeve at the initial position, which is the auxiliary device according to claim 1 or 2.

14. The diameter of the axial mounting member can decrease at the engagement position compared to the initial position, which is the auxiliary device according to claim 1 or 2.

15. The sleeve has a geometric profile to bias the axial mounting member to a smaller diameter at the engagement position compared to the initial position, which is the auxiliary device according to claim 14.

16. The auxiliary device can be removed from the injection device, and the axial mounting member and / or the rotational connection member return from the engagement position to the initial position, which is the auxiliary device according to claim 3.

17. The auxiliary device according to claim 1 or 2, which includes a sensor for detecting rotation of the adjustment dial.

18. The sleeve includes an inner circumferential wall that is conical, which is the auxiliary device according to claim 1 or 2.

19. The auxiliary device is a data collection device, which is the auxiliary device according to claim 1 or 2.

20. The data collection device includes a first and a second part. The second part is rotatably connected to the sleeve, and at least a part of the second part is axially movable relative to the first part, which is the auxiliary device according to claim 19.

21. The data collection device includes a sensor device configured to detect rotation of the second part relative to the sleeve, which is the auxiliary device according to claim 20.

22. The sleeve includes a cavity for receiving at least a part of the adjustment dial, which is the auxiliary device according to claim 1 or 2.

23. The auxiliary device according to claim 1 or 2, configured to be located on the adjustment dial so as to rotate together with the adjustment dial when attached to the injection device.

24. A method of attaching an auxiliary device to an injection device including an adjustment dial rotatably attached at its proximal end and elongated in the axial direction, comprising: placing a sleeve of the auxiliary device on the adjustment dial; deflecting an axially mounting member to an engagement position where the axially mounting member engages the adjustment dial for axially mounting the auxiliary device to the adjustment dial wherein the sleeve includes a circumferentially extending groove, the axially mounting member includes an elastically deformable ring disposed within the groove, and the elastically deformable ring is disposed to deflect outwardly at the engagement position to grip the adjustment dial.

25. The method according to claim 24, wherein the deformable ring is applied to bite into the adjustment dial at the engagement position.

26. The method according to claim 25, wherein the elastically deformable ring includes one or more blade portions.

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