Supplementary device for injection device

Abstract

To provide a data collection device that can measure information related to a condition and / or use of an injection device.SOLUTION: An injection device has a control dial that is rotatably mounted about an axis at a proximal end of the injection device. A supplementary device is attachable to the control dial. The supplementary device includes a sleeve adapted to be positioned over the control dial when the supplementary device is attached to the injection device. The supplementary device also includes an axial attachment member. The axial attachment member is arranged such that insertion of the control dial into the sleeve moves the axial attachment member from an initial position that permits axial movement of the control dial into the sleeve, into an engagement position in which the axial attachment member engages the control dial to axially attach the supplementary device to the control dial.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] The present disclosure relates to an auxiliary device for an injection device, for example a data collection device that mounts on an adjustment dial of the injection device. [Background technology]

[0002] Various diseases require regular treatment with injections of medication. Such injections can be performed using an injection device applied by a medical professional or the patient themselves. As an example, type 1 and type 2 diabetes can be treated by the patient themselves, for example, by injecting insulin doses once or several times a day. For example, a prefilled, disposable insulin pen can be used as the injection device. Alternatively, a reusable pen can be used. In a reusable pen, the empty medication cartridge can be replaced with a new one. Each pen is equipped with a set of unidirectional needles, which are replaced before each use. The insulin dose to be injected can then be manually selected on the insulin pen, for example, by turning the adjustment dial and observing the actual dose through the dose window or display on the insulin pen. The dose is then injected by inserting the needle into a suitable skin area and pressing the injection button on the insulin pen.

[0003] It is desirable to measure information related to the state and / or use of the injection device, e.g., information on injected insulin doses, so as to be able to monitor insulin injections, e.g., prevent mishandling of the insulin pen, or track doses already applied. Summary of the Invention [Means for solving the problem]

[0004] A first aspect of the present disclosure provides an auxiliary device for an injection device including an adjustment dial rotatably mounted about an axis at a proximal end thereof, the adjustment dial comprising: a sleeve adapted to be positioned over the adjustment dial when the auxiliary device is attached to the injection device; an axial mounting member arranged to move upon insertion of the adjustment dial into the sleeve from an initial position allowing axial movement of the adjustment dial into the sleeve to an engagement position engaging the adjustment dial to mount an auxiliary device to the adjustment dial;

[0013] An auxiliary device is provided, comprising:

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

[0006] The auxiliary device may further include a rotational coupling member arranged to non-rotatably couple the sleeve to the adjustment dial such that rotation of the auxiliary device causes rotation of the adjustment dial. It will be appreciated that the axial mounting member and the rotational coupling member may be different functions of the auxiliary device; however, in some embodiments, the axial mounting member and the rotational coupling member may 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 rotational coupling member can include one or more grooves positioned to engage the one or more formations to non-rotatably couple the sleeve to the adjustment dial.

[0008] The one or more grooves are adapted to receive formations having different sizes and / or shapes so that the auxiliary device can be used with a variety of injection devices. Advantageously, because the axial mounting member holds the auxiliary device on the adjustment dial, the grooves do not have to fit tightly to the formations of the various adjustment dials, but only provide a non-rotatable connection.

[0009] The axial attachment member can be positioned to engage a distal edge of the adjustment dial, which in some examples includes a distal edge of one or more formations on the adjustment dial.

[0010] In some examples, the axial mounting member can include a clamp having multiple arms, and 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] Multiple arms may protrude from the base. For example, multiple arms may protrude from a base ring, although it should be understood that in other embodiments the base may have a different shape, such as a U-shape or a 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 are movable from an initial position to an engaged position by proximal movement of the base within the sleeve.

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

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

[0015] In another example, the sleeve can include a circumferentially extending groove and the axial mounting member can include a resiliently deformable ring disposed within the groove, in this example arranged to be outwardly biased to grip said adjustment dial in the engaged position.

[0016] The deformable ring may be adapted to bite into said adjustment dial in the engaged position. The resiliently deformable ring may include one or more cutting edges. The deformable ring may include a stepped inner edge that fits over a formation on 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 an amount of medication ejected by the injection device based on the detected movement.

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

[0019] 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 embodiments, the axial mounting member can be made of a resilient material and, in an initial position, is biased in a direction to allow axial movement of the adjustment dial into the sleeve. The axial mounting member can also be made of metal.

[0020] In some embodiments, the diameter of the attachment member can be reduced in the engaged position compared to the initial position, and the sleeve can have a geometric profile such as a ramp, pilot, tapered portion, or thickened portion in the sleeve wall to bias the attachment member to a smaller diameter in the engaged 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 rotational coupling member return from the engaged position to the initial position.

[0022] In some embodiments, the injection device has a distal end opposite the proximal end, hi some embodiments, the distal end of the injection device is the end of the injection device at which the drug delivery element, e.g., a needle, is located.

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

[0024] In some embodiments, the adjustment dial of the injection device is for setting a dose, for example setting a dose 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 sit above the adjustment dial so as to rotate 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 rest on top of the adjusting dial so that it does not contact a portion of the injection device that does not rotate with the adjusting dial, e.g., the housing to which the adjusting dial is rotatably attached. However, those skilled in the art will understand that in other embodiments, the auxiliary device may abut against the non-rotating portion and move relative to the non-rotating portion as the adjusting dial rotates. For example, the auxiliary device may abut against and move on the outer surface of the housing as the adjusting dial rotates. Alternatively, a first portion of the auxiliary device may rotate with the adjusting dial, while a second portion of the auxiliary device remains stationary relative to the rest of the injection device (the adjusting dial rotates relative to the second portion of the auxiliary device), e.g., 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 comprising an adjusting dial rotatably mounted on a proximal end thereof about an axis, the auxiliary device comprising: a sleeve adapted to be positioned over the adjusting dial when the auxiliary device is attached to the injection device; and an initial sleeve adapted to allow axial movement of the adjusting dial into the sleeve upon insertion of the adjusting dial into the sleeve. and an axial mounting member arranged to move from an initial position to an engaged position that engages with the adjustment dial to attach an auxiliary device to the adjustment dial, wherein the axial mounting member includes a clamp having a plurality of arms, and in the initial position the adjustment dial is movable between the arms, and in the engaged position the arms are pressed against the adjustment dial for axial attachment, the arms extending distally from a base and abutting an inner circumferential wall of a sleeve, and moving from the initial position to the engaged position by proximal movement of the base within the sleeve.

[0029] In one embodiment, there is provided an auxiliary device for an injection device including an adjusting dial rotatably mounted on a proximal end thereof, comprising: a sleeve adapted to rest on the adjusting dial when the auxiliary device is attached to the injection device; and an axial mounting member arranged to move upon insertion of the adjusting dial into the sleeve from an initial position allowing axial movement of the adjusting dial into the sleeve, to an engaged position engaging the adjusting dial and attaching the auxiliary device to the adjusting dial, wherein the sleeve includes a circumferentially extending groove and the axial mounting member includes an elastically deformable ring disposed in the groove, the elastically deformable ring being arranged to deflect outwardly to grip the adjusting dial in the engaged position.

[0030] A further aspect of the present disclosure is a method of attaching an auxiliary device to an injection device that is axially elongated and includes an adjustment dial rotatably mounted at a proximal end, the method comprising: placing a sleeve of an auxiliary device over the adjustment dial; biasing the axial mounting member to an engagement position in which the axial mounting member engages the adjustment dial for axial attachment of an auxiliary device to the adjustment dial; The method includes:

[0031] In some examples, the axial mounting member can include a clamp having multiple arms, where in an initial position, the adjustment dial can move between the arms, and in an engaged position, the arms press against the adjustment dial for axial mounting. The multiple arms can protrude from the base. For example, the multiple arms can protrude from a base ring, although it should be understood that in other embodiments, the base can have a shape other than a ring, such as a U-shape or a solid cross-section. The base can be, for example, circular, oval, or square.

[0032] The arms extend distally from the base, abut against the inner circumferential wall of the sleeve, and are movable from an initial position to an engaged position by proximal movement of the base within the sleeve.

[0033] In another example, the sleeve can include a circumferentially extending groove and the axial mounting member can include a resiliently deformable ring disposed within the groove, in this example arranged to be outwardly biased to grip said adjustment dial in the engaged position.

[0034] Examples will now be described with reference to the accompanying drawings. [Brief explanation of the drawings]

[0035] [Figure 1] FIG. 10 is an exploded view of an injection device used with a data collection device. [Figure 2] FIG. 2 is a diagram of a data collection device attached to the injection device of FIG. 1. [Figure 3] FIG. 2 is a diagram of a data collection device attached to the injection device of FIG. 1, with a cross section of the data collection device shown. [Figure 4A] 2A-2C are diagrams showing different examples of the adjustment dial of the injection device of FIG. 1. [Figure 4B] 2A-2C are diagrams showing different examples of the adjustment dial of the injection device of FIG. 1. [Figure 5] FIG. 2 is a diagram of an example of a data collection device attached to the injection device of FIG. 1. [Figure 6A] 6 is a cross-sectional view of the data collection device of FIG. 5 when attached to the injection device of FIG. 1. [Figure 6B] 6 is a cross-sectional view of the data collection device of FIG. 5 when attached to the injection device of FIG. 1. [Figure 7] FIG. 6 is a cross-sectional view of the data collection device of FIG. 5. [Figure 8A] 6 is a cross-sectional view of a variation of the data collection device of FIG. 5. [Figure 8B] 6 is a cross-sectional view of a variation of the data collection device of FIG. 5. [Figure 8C] 6 is a cross-sectional view of a variation of the data collection device of FIG. 5. [Figure 9A] FIG. 2 is a diagram of a further example of a data collection device attached to the injection device of FIG. 1. [Figure 9B] 9B is a cross-sectional view of the data collection device of FIG. 9A when attached to the injection device of FIG. 1. [Figure 10] FIG. 2 is a diagram of a further example of a data collection device attached to the injection device of FIG. 1. [Figure 11] FIG. 11 is a diagram of a mounting member for the data collection device of FIG. 10. [Figure 12] 12 is a cross-sectional view of the data collection device of FIG. 10, the mounting member of FIG. 11, and the injection device of FIG. 1. [Figure 13A] 11 is a cross-sectional view of the data collection device of FIG. 10 in the process of being attached to the injection device of FIG. 1. [Figure 13B] 11 is a cross-sectional view of the data collection device of FIG. 10 in the process of being attached to the injection device of FIG. 1. [Figure 13C] 11 is a cross-sectional view of the data collection device of FIG. 10 in the process of being attached to the injection device of FIG. 1. [Figure 14] FIG. 2 is a diagram of a further example of a data collection device attached to the injection device of FIG. 1. [Figure 15] FIG. 15 is a diagram of a mounting member for the data collection device of FIG. 14. [Figure 16] 15 is a cross-sectional view of the data collection device of FIG. 14 attached to the injection device of FIG. 1. [Figure 17A] 16 is a cross-sectional view of an edge of the mounting member of FIG. 15. FIG. [Figure 17B] 16 is a cross-sectional view of an edge of the mounting member of FIG. 15. FIG. [Figure 18] FIG. 15 is a diagram of an alternative mounting member for the data collection device of FIG. 14. [Figure 19A] FIG. 15 is a diagram of an alternative mounting member for the data collection device of FIG. 14. [Figure 19B] FIG. 15 is a diagram of an alternative mounting member for the data collection device of FIG. 14. DETAILED DESCRIPTION OF THE INVENTION

[0036] The present specification discloses auxiliary devices for injection devices. The auxiliary device is attachable to the injection device to perform an auxiliary function. In some examples, the auxiliary device is a data collection device attachable to the injection device, such as a pen syringe, so as to fit onto the injection device, e.g., as a cap, over an adjustment dial at the proximal end of the injection device. In particular, the data collection device includes a sleeve that receives the adjustment dial. The sleeve defines a cavity into which the adjustment dial is pressed to attach the data collection device to the injection device. In various examples described herein, the data collection device includes an axial mounting member that attaches the data collection device to the adjustment dial to axially hold the data collection device on the injection device. An additional rotational coupling member can be provided to non-rotatably couple the data collection device to the adjustment dial.

[0037] When attached to the control dial of the injection device, the data collection device can be operated by a user to cause 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 medication 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, particularly the attachment feature, can be configured to attach to a series of different injection devices, thus allowing monitoring of a user's medication treatment across multiple devices. Furthermore, this can be achieved without interfering with normal use of the injection device or obscuring the dosage window of the injection device.

[0038] Some examples are described below with reference to insulin injection devices, however the present disclosure is not limited to such applications and may be equally well applied to injection devices releasing other medications.

[0039] Additionally, some examples are described below with reference to auxiliary devices that are data collection devices. However, the present disclosure is not limited to data collection devices, and the auxiliary device may equally well be a different type of auxiliary device for an injection device. 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 medication delivery device, in this example an injection device 1 such as the Sanofi SoloSTAR® insulin injection pen.

[0041] The injection device 1 of FIG. 1 is a disposable, pre-filled injection pen containing an insulin container 3 that includes a housing 2 and to which a needle 4 can be attached. The needle 4 is protected by an inner needle cap 5 and either an outer needle cap 6 or an alternative cap 7. The insulin dose to be released from the injection device 1 can be programmed or "dialed in" by turning an adjustment dial 8, with the currently programmed dose displayed, e.g., in multiple units, via a dosage window 9. For example, if the injection device 1 is configured to administer human insulin, the dosage is displayed in so-called international units (IU), with 1 IU being bioequivalent to approximately 45.5 micrograms (1 / 22 mg) of pure crystalline insulin. In injection devices that deliver analog insulin or other medications, other units may be used. Note that the selected dose may be displayed equally well in a manner different from that shown in the dosage window 9 of FIG. 1.

[0042] The distal end D of the injection device 1 as shown herein 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 of the injection device 1 opposite the needle 4.

[0043] The adjusting 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 adjusting dial 8 is rotatable about the axis of the injection device 1. The elongated housing 2 of the injection device 1 extends in the axial direction.

[0044] The dosage window 9 may be in the form of an aperture in the housing 2 that allows the user to view a limited portion of the number sleeve 10 that is configured to move as the adjustment dial 8 is turned, thus providing a visual indication of the currently programmed dose. The adjustment dial 8 rotates in a helical path relative to the housing 2 as it is turned during programming.

[0045] In this example, adjustment dial 8 is used when no auxiliary device is used. It includes one or more formations 11a, 11b, 11c to facilitate gripping, which are described in more detail herein below with reference to Figures 4A and 4B.

[0046] The injection device 1 can be configured so that turning the adjustment dial 8 produces a mechanical click sound, providing acoustic feedback to the user. The number sleeve 10 mechanically interacts with a piston in the insulin container 3. Inserting the needle 4 into the patient's skin area and pressing the injection button 12 will cause the insulin dose displayed in the display window 9 to be released from the injection device 1. The majority of the dose is actually injected into the patient's body during the time that the needle 4 of the injection device 1 remains within the skin area after the injection button 12 is pressed. The release of the insulin dose may also produce a mechanical click sound, but this click sound is different from the sound produced when the adjustment dial 8 is used.

[0047] In this embodiment, during delivery of an insulin dose, the adjusting dial 8 moves axially, i.e., without rotation, towards its initial position, while the number sleeve 10 rotates back to its initial position, e.g., to display 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 expiry date of the medication in the injection device 1 is reached (eg 28 days from first use).

[0049] Furthermore, before using the injection device 1 for the first time, it may be necessary to perform a so-called "prime shot" by selecting, for example, 2 units of insulin and removing air from the insulin container 3 and the needle 4 by pressing the injection button 12 while holding the injection device 1 with the needle 4 pointing upwards. For simplicity of presentation, it is assumed below that the emitted amount substantially corresponds to the injected dose, and thus, for example, the amount of drug emitted from the injection device 1 is equal to the dose received by the user. Nevertheless, differences (e.g. losses) between the emitted amount and the injected dose may need to be taken into account.

[0050] 2 is a perspective view of the proximal end P of the injection device 1 when a data collection device 20 is attached. The data collection device 20 includes a housing 21 and an end plate 22 that includes 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 described further herein below.

[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, rotating the data collection device 20 to use the injection device 1 rotates the adjustment dial 8 (see Figure 1) as described above.

[0052] 3 is a cross-sectional view of an example of a data collection device 20 when attached to an injection device 1. The data collection device 20 includes a housing 21 that includes a sleeve 23 that is positioned over 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. A 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 understood that FIG. 3 is a simplified illustration of the data collection device 20. In various examples, the data collection device 20 may include additional components. For example, the data collection device may include a second component movably coupled to the sleeve 23. For example, the second component may rotate or move axially relative to the sleeve 23. The data collection device 20 may include a button. The button may be depressible relative to another component of the data collection device 20. The button may include a spring. However, such a button is not required. For example, the data collection device 20 may determine use of the injection device 1 if a sensor detects rotation of the adjustment dial. In one embodiment, the data collection device 20 may have a motion sensor, such as an accelerometer, that detects 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 motion sensor are omitted, and instead the data collection device 20 is always powered on.

[0054] Additionally, the data collection device 20 may include various electronic components. For example, the data collection device 20 may include one or more of a power source, e.g., 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 arranged to detect axial movement of a part, for example a button, of the data collection device 20. In this way, the data collection device 20 can detect use of the injection device 1.

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

[0057] In this arrangement, the sleeve 23 is shaped such that the engagement between the sleeve 23 and the adjusting dial 8 is substantially uniform along the entire axial length of the adjusting dial 8. This helps to ensure the correct axial orientation of the data collection device 20 relative to the injection device 1. This axial orientation occurs because the components are shaped such that an incorrect orientation would result in a radial corrective force between the adjusting dial 8 and the sleeve 23 when they are mated together. Correct axial alignment is useful because it allows for better transmission of rotational forces from the sleeve 23 to the adjusting dial 8, and also provides better feedback to the user when performing dose delivery. This also generally improves the user experience.

[0058] To set the medication dosage to be administered, the user can grasp and rotate the data collection device 20, which will turn the adjustment dial 8 of the injection device 1 and program the dosage.

[0059] Different injection devices similar to SoloStar®, or variations of SoloStar®, may have differently shaped adjustment dials 8. For example, FIG. 4A shows a first adjustment dial 8a, and FIG. 4B shows another adjustment dial 8b. The exemplary adjustment dials 8a, 8b each include a dial member 13 and an injection button 12. The dial member 13 has a slightly conical shape that tapers toward the injection button 12 at its proximal end.

[0060] As shown, the formations 11a, 11b, 11c, 11d, 11e, and 11f are formed around the circumferential surface of the dial member 13. The formations 11a, 11b, 11c, 11d, 11e, and 11f protrude from the circumferential surface of the dial member 13. The formations 11a, 11b, 11c, 11d, 11e, and 11f are spaced apart around the dial member 13 and extend in an axial direction. Extends in the direction.

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

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

[0063] The forming portions 11a, 11b, and 11c of the adjustment dial 8a are different from the forming portions 11d, 11e, and 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 may include a single feature that is larger than other features. For example, the larger feature may act as an indicator to the user of the rotational position of the adjustment dial 8.

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

[0066] Adjusting dials 8a, 8b of different shapes can also be used for different injection devices 1, for example injection devices 1 containing different medicaments. Alternatively, the forming portions 11 of adjusting dials 8a, 8b from different factories can be different. Advantageously, the data collection device 20 can be adapted to different types of adjusting dials 8a, 8b so that it can be used with different injection devices 1. The examples of data collection devices 20 described herein below can be attached to different adjusting dials 8a, 8b, taking into account variations in the shapes of the forming portions 11a, 11b, 11c, 11d, 11e, 11f of the adjusting dials 8a, 8b.

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

[0068] The data collection device 20 of Figure 5 includes a sleeve 23 defining a cavity 24 for receiving the adjustment dials 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 adapted to substantially match the outer profile of the various adjustment dials 8a, 8b such that the sleeve 23 fits over the adjustment dials 8a, 8b.

[0069] Specifically, inner circumferential wall 25 is conical and conforms to the outer shape of adjustment dial 8. Inner circumferential wall 25 further includes a plurality of grooves 26. Grooves 26 are large enough to accommodate any of formations 11a, 11b, 11c, 11d, 11e, 11f on any of the various adjustment dials, for example, adjustment dials 8a, 8b of Figures 4A and 4B.

[0070] As shown in Figure 5, the inner circumferential wall further includes a wider groove 27 adapted to receive the larger formation as described with reference to Figures 4A and 4B. The wider groove 27 may include a funnel-shaped opening 28, as shown in Figure 5. The funnel-shaped opening 28 allows the data collection device 20 to expand when the data collection device 20 is pressed onto the adjustment dials 8a, 8b. The device 20 can be rotated to serve for rotational alignment with the formations 11a, 11b, 11c, 11d, 11e, 11f of the adjustment dials 8a, 8b.

[0071] 5 and 6A, data collection device 20 further includes a deformable portion 29 positioned to define a portion of inner circumferential wall 25. Deformable portion 29 extends circumferentially around cavity 24 at a proximal end thereof. Deformable portion 29 is positioned to grip formations 11a, 11b, 11c, 11d, 11e, and 11f to non-rotatably couple data collection device 20 to adjustment dial 8.

[0072] 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, with the inner circumferential wall 25 substantially conforming to the outer shape of the adjustment dial 8. As also shown, the tops of the formations 11 a, 11 b of the adjustment dial 8 engage the deformable portion 29 of the inner circumferential wall 25. Specifically, the proximal ends of the formations 11 a, 11 b contact the deformable portion 29.

[0073] As shown in FIG. 6B, which is an enlarged view of a portion of FIG. 6A, the inner circumferential wall 25 of the sleeve 23 has an axial 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. The snap portion 31 is positioned 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] 6A and 6B, the distal edge 30 of the adjustment dial 8 includes a cutback portion 49 that engages the snap portion 31. In other examples, the distal edge 30 of the adjustment dial 8 can be radiused or angled to engage the snap portion 31.

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

[0077] 5 and 7, the data collection device 20 has one snap portion 31 for each of the forming portions 11a, 11b, 11c, 11d, 11e, and 11f of the adjustment dial 8. In another example, the data collection device 20 has two or more snap portions 31 that are positioned to engage with the distal edges 30 of a corresponding number of the forming portions 11a, 11b, 11c, 11d, 11e, and 11f of the adjustment dial 8. In another example, there is one snap portion 31 for each of the forming portions 11a, 11b, 11c, 11d, 11e, and 11f.

[0078] The snap-fit ​​arrangement provided by one or more snap portions 31 of the data collection device 20 provides an axial attachment of the data collection device 20 to the injection device 1, and in particular to the adjustment dial 8. That is, the snap-fit ​​arrangement holds the data collection device 20 axially on the adjustment dial 8. The snap portions 31 can be considered as axial attachment members.

[0079] To attach the data collection device 20 to the adjustment dial 8, the forming portion of the adjustment dial 8 The data collection device 20 is pressed onto the injection device 1 with the grooves 26 aligned with the grooves 11a, 11b, 11c, 11d, 11e, and 11f. As the data collection device 20 is pressed onto the adjusting dial 8, the snap portions 31 engage with the formations 11a, 11b, 11c, 11d, 11e, and 11f of the adjusting dial 8 and deflect outward as the adjusting dial 8 moves within the cavity 24. When the adjusting dial 8 is properly inserted into the cavity 24, the snap portions 31 engage the adjusting dial 8 by snapping over the distal edge 30 and under the distal edge 30 of the adjusting dial 8. The data collection device 20 is now axially attached to the adjusting dial 8.

[0080] As mentioned above, in this position, the proximal ends of formations 11 a, 11 b, 11 c, 11 d, 11 e, 11 f of adjustment dial 8 engage deformable portion 29. The engagement between formations 11 a, 11 b, 11 c, 11 d, 11 e, 11 f and grooves 26 and / or between formations 11 a, 11 b, 11 c, 11 d, 11 e, 11 f and deformable portion 29 provides a non-rotatable coupling of data collection device 20 to adjustment dial 8.

[0081] In this manner, data collection device 20 can be axially mounted and non-rotatably coupled to adjustment dial 8. Advantageously, groove 26 and deformable portion 29 are not required to provide axial mounting of data collection device 20 to adjustment dial 8, as that function is provided by a snap-fit ​​arrangement. Groove 26 and deformable portion 29 can therefore be adapted to fit a wide variety of formations 11a, 11b, 11c, 11d, 11e, 11f, as their function only provides a non-rotatable connection. However, it will be appreciated that deformable portion 29 can also be an axial mounting member if desired.

[0082] As will be explained herein below, the deformable portion 29 may be varied to better engage with the various formations 11 a, 11 b, 11 c, 11 d, 11 e, 11 f of the adjustment dial 8.

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

[0084] 7, the deformable portion 29 is integrally molded with the sleeve 23. For example, the sleeve 23 is molded from a rigid plastic material, such as a thermoplastic material, and the deformable portion 29 is simultaneously molded. Such a dual-molding process can be achieved, for example, using injection molding. Alternatively, the deformable portion 29 may be glued or welded to the sleeve 23. In another example, the deformable portion 29 may be captured between two members of the data collection device 20 and held in place by the two members being attached to one another.

[0085] The deformable portion 29 may be made from a flexible, elastic material, for example rubber.

[0086] As shown, the deformable portion 29 is disposed at the proximal end P of the cavity 24 to engage the proximal ends of the formations 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 includes ribs 32 that correspond to the grooves 26. In the example of FIG. 7, there are five ribs 32, one for each groove 26. The ribs 32 extend in the axial direction. The ribs 32 are aligned with the formations 11a, 11b, 11c, and 11d when the data collection device 20 is attached to the adjustment dial 8. , 11 e, 11 f to provide a non-rotatable connection between the data collection device 20 and the adjustment dial 8 .

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

[0089] 8A, the deformable portion 29 is as described with reference to FIG. 7, but does not have ribs 32 formed therein that align with the grooves 26. In this example, the material of the deformable portion 29 may be more malleable (i.e., more flexible) so that the data collection device 20 can be attached to the adjustment dial 8 without the application of undue force.

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

[0091] 8C, the deformable portion 29 is as described with reference to FIG. 7, but the ribs 32 that align with the grooves 26 are circumferentially wider. The wider ribs 32 require more force to deform to allow coupling of the data collection device 20 to the adjustment dial 8, but can provide a stronger non-rotatable coupling between the data collection device 20 and the adjustment dial 8.

[0092] Figures 9A and 9B show a further example of a 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 means of a 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 are slots 34 that extend from the top of the proximal end of the cavity 24 toward the open distal end.

[0094] Each arm 33 has on its inner surface a recess 35 adapted to receive one of the formations 11a, 11b, 11c, 11d, 11e, and 11f of the adjusting dial 8. Snap portions 31 are provided at the distal end of the arms 33 in the same positions as in the example of Figures 5 to 8C. These snap portions 31 are arranged to engage with the distal edges 30 of the adjusting dial 8, e.g., the distal ends of the formations 11a, 11b, 11c, 11d, 11e, and 11f, as described with reference to Figures 6A and 6B.

[0095] 9A and 9B, the proximal end of the recess 35 is provided with a proximal snap portion 36. The proximal snap portion 36 is positioned to engage with the proximal ends of the forming portions 11a, 11b, 11c, 11d, 11e, and 11f of the adjustment dial 8.

[0096] The proximal ends of formations 11a, 11b, 11c, 11d, 11e, and 11f may be rounded, chamfered, or cut back so that proximal snap portions 36 can engage formations 11a, 11b, 11c, 11d, 11e, and 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. Pushing the data collection device 20 axially causes the adjustment dial 8 to deflect the snap portion 31. When the adjustment dial 8 engages the proximal snap portion 36, the arms 33 are deflected outward. When the adjustment dial 8 is fully inserted, the snap portion 31 engages the distal edge 30 of the adjustment dial 8 as described above, and the proximal snap portion 36 is deflected outward. Snap portions 31 and 36 may be considered axial attachment members. Additionally, formations 11a, 11b, 11c, 11d, 11e, and 11f are disposed in recesses 35, thereby non-rotatably coupling data collection device 20 to adjustment dial 8.

[0098] Slots 34 between arms 33 allow for outward deflection of arms 33, movement of proximal snap portions 36 to an engaged position, and movement of formations 11 a, 11 b, 11 c, 11 d, 11 e, 11 f into recesses 35.

[0099] In the example of FIGS. 5-9B, the snap portions 31, 36 are biased from an initial position to an engaged position as the data collection device 20 is pressed onto the adjustment dial 8.

[0100] 10, 11 and 12 show a further example of a data collection device 20 adapted to fit onto an adjustment dial 8, such as the adjustment dials 8a, 8b of FIGS. 4A and 4B, as well as 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 that receives 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 one another. 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, 40 are positioned to clamp onto adjustment dial 8 as adjustment dial 8 is pressed into cavity 24 and clamp 37 moves axially in the proximal direction. In this embodiment, clamp 37 can be considered an axial mounting member.

[0103] The clamp 37 includes long arms 39 and short arms 40 arranged alternately around the clamp 37. The long arms 39 are positioned so as to be located between the formed portions 11a, 11b, 11c, 11d, 11e, and 11f of the adjustment dial 8 when the data collection device 20 is attached to the adjustment dial 8. The short arms 40 are positioned so as to be located above the formed portions 11a, 11b, 11c, 11d, 11e, and 11f of the adjustment dial 8 when the data collection device 20 is attached to the adjustment dial 8.

[0104] As also shown, circumferential wall 25 includes a plurality of grooves 41 positioned to receive arms 39, 40 of clamp 37. Grooves 41 corresponding to short arms 40 are further adapted to receive formations 11a, 11b, 11c, 11d, 11e, 11f of adjustment dial 8.

[0105] As shown, the distal ends 42 of the long arms 39 are bent inwardly.

[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 protrusions 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 multiple separate protrusions 43 that are aligned with the long arms 39.

[0107] 13A to 13C show the data collection device 20 of FIGS. 10 to 12 with the adjustment dial 8. 13A illustrates the installation process. As shown in FIG. 13A, clamp 37 is in an initial position, partially received in cavity 24, with arms 39, 40 in an undeflected state and open enough to receive adjustment dial 8 between them, as shown in FIG. 13B. As adjustment dial 8 is pressed into cavity 24, the interior shape of cavity 24 biases arms 39, 40 inward to an engaged position, gripping adjustment dial 8, as shown in FIG. 13B. In the position shown in FIG. 13C, adjustment dial 8 is fully inserted into cavity 24, with arms 39, 40 gripping adjustment dial 8.

[0108] Protrusions 43 on inner circumferential wall 25 interact with inwardly deflected ends 42 of long arms 39 to retain clamp 37 and adjustment dial 8 within cavity 24. Specifically, as adjustment dial 8 is pressed into cavity 24, long arms 39 straighten slightly at deflected ends 42, allowing the bent portion of each long arm 39 to move proximally over protrusion 43. Once long arms 39 clear protrusion 43, they return, effectively locking clamp 37 into the cavity.

[0109] 13C position, formations 11a, 11b, 11c, 11d, 11e, and 11f of adjustment dial 8 and short arms 40 of clamp 37 are within grooves 41. Short arms 40 can be positioned to deflect as adjustment dial 8 is pressed into cavity 24, exerting an inward gripping force on formations 11a, 11b, 11c, 11d, 11e, and 11f. Similarly, in the FIG. 13C position, long arms 39 of clamp 37 are slightly deflected, thereby exerting an inward gripping force on adjustment dial 8. In some examples, deflected ends 42 of long arms 39 can extend below distal end 30 of adjustment dial 8.

[0110] Thus, the data collection device 20 is axially attached to the adjustment dial 8 by the arms 39, 40 of the clamp 37. Additionally, grooves 41 that receive the formations 11a, 11b, 11c, 11d, 11e, 11f non-rotatably connect the data collection device 20 to the adjustment dial 8.

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

[0112] In this example, data collection device 20 includes a sleeve 23 having an inner circumferential wall 25 that defines a cavity 24 that receives adjustment dial 8. In this example, inner circumferential wall 25 has a circumferentially extending groove 44. Groove 44 is positioned to receive a mounting ring 45, which is shown in FIG. 15 and can be seen in place in FIG. 16.

[0113] 16, the mounting ring 45 is positioned within the groove 44 such that its inner edge 46 extends from the groove 44 into the cavity 24. In this manner, the inner edge 46 engages the adjustment dial 8 when the adjustment dial 8 is pressed into the cavity 24.

[0114] Attachment ring 45 comprises a resilient material and includes a slit 47. In an initial position, attachment ring 45 extends into cavity 24 and deforms outward under the force of adjustment dial 8 as adjustment dial 8 is pressed into cavity 24. In response, the resiliency of attachment ring 45 causes inner edge 46 to grip adjustment dial 8, axially attaching data collection device 20 to adjustment dial 8. In this position, attachment ring 45 is in an engaged position. Attachment ring 45 can be considered an axial attachment member in this example.

[0115] The resilience of the mounting ring 45 and / or the design of the inner edge 46 may be such that the mounting ring 45 is The attachment ring 45 may be adapted to grip or bite into the adjustment dial 8. The attachment ring 45 may grip or bite into the outermost features of the adjustment dial, as these are the formations 11a, 11b, 11c, 11d, 11e, and 11f. It will be appreciated that the attachment ring may also provide the feature of a rotational coupling.

[0116] As shown in Figure 14, the inner circumferential wall 25 of the sleeve 23 further includes grooves 26 similar to those described with reference to Figure 5 that receive the formations 11a, 11b, 11c, 11d, 11e, 11f of the adjustment dial 8 and provide a non-rotatable connection between the data collection device 20 and the adjustment dial 8. A wider groove 27 with an optional funnel-shaped mouth 28 may be provided to accommodate larger formations.

[0117] As shown in Figure 17A, the inner edge 46' of the mounting ring 45' may be square, and the resilient force of the mounting ring 45' may press against the adjustment dial 8' to provide axial attachment. Alternatively, as shown in Figure 17B, the inner edge 46' of the mounting ring 45' may be angled to provide a cutting edge that bites into the adjustment dial 8' to provide axial attachment.

[0118] 18, an inner edge 46 of the attachment ring 45 may be stepped with recesses 47 provided to accommodate the formations 11a, 11b, 11c, 11d, 11e, and 11f of the adjustment dial 8. In this manner, the attachment ring 45 can grip or bite into the formations 11a, 11b, 11c, 11d, 11e, and 11f and the main portion of the adjustment dial 8 between the formations 11a, 11b, 11c, 11d, 11e, and 11f.

[0119] 19A and 19B, the inner edge 46 of the mounting ring 45 may include serrations 48 to increase the gripping or biting force provided by the resilient force of the mounting ring 45 pressing against the adjustment dial 8. As shown in FIG. 19A, the serrations 48 may be provided on a stepped mounting ring 45 such as that shown in FIG. 18. Alternatively, the serrations 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 serrations 48 may be arranged in spaced groups around the attachment ring 45.

[0121] It will be understood that in each described example, any feature capable of providing an axial attachment can be considered an axial attachment member, and any feature capable of providing a non-rotatable connection can be considered a rotational connection member.

[0122] The axial attachment prevents decoupling of the data collection device from the adjustment dial, while the rotational coupling allows the data collection device to move in unison with the adjustment dial.

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

[0124] The injection device 1 is configured to inject or infuse a medication into a patient. For example, delivery can be subcutaneous, intramuscular, or intravenous. Delivery can be needleless. The injection device 1 can be operated by a patient or a healthcare professional, 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, where a sealed ampoule must be pierced before use. The volume of medication delivered by these various devices can range from about 0.5 ml to about 2 ml. The injection device 1 can also be a large volume device ("LVD") or patch pump, and can deliver a large amount of medication over a period of time (e.g., The injection device 1 is configured to adhere to the patient's skin over a period of time (e.g., about 5, 15, 30, 60, or 120 minutes) to deliver a "large" volume of medication (typically about 2 ml to about 10 ml). In combination with a specific medication, the injection device 1 can also be customized to operate within required specifications. For example, the injection device 1 can be customized to inject medication within a specific time period (e.g., about 3 to about 20 seconds for an auto-injector, or about 10 to about 60 minutes for an LVD). Other specifications can include low or minimal levels of discomfort, or specific conditions related to human factors, shelf life, expiration date, biocompatibility, environmental considerations, etc. Such variations can be caused by various factors, such as the viscosity of the medication, which ranges from about 3 cP to about 50 cP. Accordingly, the injection device 1 can include a hollow needle ranging in size from about 25 to about 31 gauge. Common sizes are 27 and 29 gauge.

[0125] The injection device 1 may also include one or more automated features. For example, one or more of needle insertion, medication injection, and needle retraction may be automated. Energy for one or more automated steps may be provided by one or more energy sources.

[0126] The energy source may include, for example, mechanical, pneumatic, chemical, or electrical energy. For example, a mechanical energy source may include a spring, lever, elastomer, or other mechanical mechanism for storing or releasing energy. One or more energy sources may be combined within a single device. The device may further include gears, valves, or other mechanisms for converting 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, a lever, a needle sleeve, or other activation components. Activating an automatic function can be a single-step or multi-step process. That is, a user may need to activate one or more activation components for the automatic function to occur. For example, in a single-step process, a user may depress the needle sleeve against their body to allow injection of the medication to be delivered. An injection device 1 may also require multiple-step activation of an automatic function. For example, a user may need to depress a button and retract the needle shield to perform an injection.

[0128] Additionally, activation of one automatic function may activate one or more subsequent automatic functions, thereby forming an activation sequence. For example, activation of a first automatic function may activate at least two of needle insertion, medication injection, and needle retraction. The injection device 1 may also require a specific sequence of steps for one or more automatic functions to occur. The injection device 1 may also operate through a sequence of independent steps.

[0129] The injection device 1 may include one or more features of a safety syringe, a pen injector, or an auto-injector. For example, the injection device 1 may include a mechanical energy source (typically found in an auto-injector) configured to automatically inject a medication 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-configurable dose.

[0132] The drug or agent 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 storage (e.g., short-term or long-term storage) of one or more pharmaceutically active ingredients. For example, in some cases, the chamber can be designed to store 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 a drug for about one month to about two years. Storage can occur at room temperature (e.g., about 20°C) or refrigerated temperatures (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 two or more components of a drug formulation (e.g., a drug and a diluent, or two different types of drugs), one 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 a drug or medication before and / or during administration to the 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 a user to mix the two components before administration, if desired. Alternatively or additionally, the two chambers can be configured to allow mixing upon administration of the components to the 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, and thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. 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 "medicament" are used interchangeably herein to describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or medications are used to treat, cure, prevent, or diagnose disease or otherwise improve physical or mental well-being. Drugs or medications can be used for a limited duration or periodically for chronic disorders.

[0136] As described below, drugs or pharmaceutical agents may contain at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs may 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, as well as 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] The drug or agent can be contained in a primary package or "drug container" adapted for use in a drug delivery device. A drug container can be, for example, a container configured to provide a suitable chamber for storage (e.g., short-term or long-term storage) of one or more drugs. The drug container may 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 one day (e.g., one day to at least 30 days). In some cases, the chamber can be designed to store the drug for about one month to about two years. Storage can occur at room temperature (e.g., about 20°C) or at refrigerated temperatures (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 two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between the two or more components before and / or during administration to the 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 a user, if desired, before administration. Alternatively or additionally, the two chambers may be configured to allow mixing of the components upon administration to the human or animal body.

[0138] The drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, and thromboembolic disorders, such as deep vein thromboembolism or pulmonary embolism. Further examples of disorders include 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 listed in handbooks such as Rote Liste 2014 (e.g., but not limited to, Main Group 12 (antidiabetic agents) or 86 (oncology agents)) and the Merck Index, 15th edition.

[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, e.g., human insulin, or a human insulin analog or derivative; glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, or an analog or derivative thereof; a dipeptidyl peptidase-4 (DPP4) inhibitor; or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deletion and / or replacement 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 replaced amino acid residue can be either a codable amino acid residue, another naturally occurring residue, or a purely synthetic amino acid residue. 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 (e.g., 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, including non-codable ones, are added to the naturally occurring peptide.

[0140] Examples of insulin analogs include 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 is 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 are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 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®); 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 are, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flathead monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rexendin -4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C, CM-3, GLP-1 Erigen, ORMD-0901, NN-9924, NN-9926, NN-9927, nodexene, Viadol-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] An example of an oligonucleotide is, for example, mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia.

[0144] Examples of DPP4 inhibitors are vidagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0145] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropine (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0146] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low-molecular-weight heparin or ultra-low-molecular-weight heparin or derivatives thereof, or sulfated polysaccharides, such as the polysulfated forms of the aforementioned polysaccharides, and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low-molecular-weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives include Hylan G-F20 (Synvisc®) and 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 antigen-binding ability. An antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single-chain antibody. In some embodiments, an antibody has effector function and is capable of fixing complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, antibody fragment, or mutant that does not support Fc receptor binding, e.g., with a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable region antibody-like binding proteins (CODVs) with a crossover binding region orientation.

[0148] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to antigen. Antibody fragments can include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present disclosure include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, e.g., bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, e.g., bivalent, trivalent, tetravalent, and multivalent antibodies, minibodies, chelating 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 "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the proper positioning of the CDR sequences to enable antigen binding. Although the framework region itself is typically not directly involved in antigen binding, as is known in the art, certain residues within the framework region of a particular antibody may be directly involved in antigen binding or may 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 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

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

[0152] Those skilled in the art will understand that modifications (additions and / or deletions) to the various components of the APIs, formulas, apparatus, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present disclosure, and that the present disclosure encompasses all such modifications and any equivalents thereof.

Claims

1. 1. An auxiliary device for an injection device including an adjustment dial rotatably mounted about an axis at a proximal end thereof, the adjustment dial comprising: a sleeve adapted to be positioned over the adjustment dial when the auxiliary device is attached to the injection device; an axial mounting member arranged to move upon insertion of the adjustment dial into the sleeve from an initial position allowing axial movement of the adjustment dial into the sleeve to an engagement position engaging the adjustment dial to mount an auxiliary device to the adjustment dial; The auxiliary device.

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

3. 3. An auxiliary device according to claim 1 or 2, further comprising a rotational coupling member arranged to non-rotatably couple the sleeve to the adjustment dial such that rotation of the auxiliary device causes rotation of the adjustment dial.

4. The auxiliary device of claim 3 , wherein the axial mounting member and the rotational coupling member are a single component of the auxiliary device.

5. 5. The auxiliary device of claim 3 or 4, wherein the adjustment dial includes one or more axially extending formations protruding from the adjustment dial, and the rotational coupling member includes one or more grooves arranged to engage the one or more formations to non-rotatably couple the sleeve to the adjustment dial.

6. 6. An auxiliary device according to claim 5, wherein one or more grooves are adapted to receive formations having different sizes and / or shapes so that the auxiliary device can be used with a variety of injection devices.

7. An auxiliary device according to any one of claims 1 to 6, wherein the axial mounting member is arranged to engage a distal edge of the adjustment dial.

8. 8. An auxiliary device according to any one of claims 1 to 7, wherein the axial mounting member comprises a clamp having a plurality of arms, and 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.

9. The auxiliary device of claim 8 , wherein the plurality of arms protrude from the base.

10. The auxiliary device of claim 9 , wherein the base includes a base ring and the plurality of arms project from the base ring.

11. 11. An assist device according to claim 9 or 10, wherein the arms extend distally from the base and abut an inner circumferential wall of the sleeve, and are moved from an initial position to an engaged position by proximal movement of the base within the sleeve.

12. An auxiliary device according to any one of claims 8 to 11, wherein the distal ends of the arms are bent inwardly so as to press against the adjustment dial in the engaged position.

13. An auxiliary device according to any one of the preceding claims, wherein the axial mounting member comprises a snap portion arranged to engage with a rim of the adjustment dial in a snap-fit ​​manner.

14. 8. An auxiliary device according to any one of claims 1 to 7, wherein the sleeve includes a circumferentially extending groove, and the axial mounting member includes a resiliently deformable ring disposed within the groove, the resiliently deformable ring being arranged to deflect outwardly in an engaged position to grip the adjustment dial.

15. An auxiliary device according to any one of the preceding claims, wherein the diameter of the attachment member is reduced in the engaged position compared to the initial position.

16. 1. A method of attaching an auxiliary device to an injection device that is axially elongated and includes an adjustment dial rotatably mounted at a proximal end, the method comprising: placing a sleeve of an auxiliary device over the adjustment dial; biasing the axial mounting member to an engagement position in which the axial mounting member engages the adjustment dial for axial attachment of an auxiliary device to the adjustment dial; The method comprising:

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