Dial grip for an injection device

Abstract

A dial grip (10) for an injection device (50) includes a grip base (12), an operating portion (14) disposed on one side (16) of the grip base (12), and a coupling (18) disposed on the other side (20) of the grip base (12) for releasable engagement with a dose selecting portion of a dose selecting and expelling mechanism of the injection device to couple the grip base (12) to the dose selecting and expelling mechanism for selecting and expelling a dose with the dial grip (10).

Description

Technical Field

[0001] This disclosure relates to a dial grip for an injection device. Background Technology

[0002] Many diseases require regular treatment through the delivery or injection of medications or drugs. These injections can be administered using an injection device, either by a healthcare professional or by the patient themselves.

[0003] The injection device can be disposable or reusable, such as the disposable Solostar. TM Both the injection pen and the reusable Allstar™ injection pen are from Sanofi. Allstar is described in detail in International Patent Application WO 2014 / 033195 A1. TM The mechanical structure of an injection pen. Injection pens such as Solostar. TM and Allstar TM The injection pen includes a distal end and a proximal end, wherein, in the context of this disclosure, the term "proximal" refers to the direction in which the injection is directed towards the patient, and the term "distal" refers to the opposite direction away from the patient. Solostar TM and Allstar TM A button or knob at the distal end of the injection device acts as a dial grip for selecting the dose to be injected using the device. Summary of the Invention

[0004] This disclosure describes different concepts of a dial grip for an injection device, particularly for a needle-based injection system for patient self-administration of medication. The dial grip can be configured for releasable attachment to the injection device and, according to one embodiment, can function as, for example, a simulated dial grip for transporting the injection device. The dial grip can be configured for dose selection using the injection device. The injection device can be a pen-shaped device having a distal end and a proximal end, and the dial grip can form the distal end of the injection pen, which can be rotated by the patient to select or set a customized dose. In some embodiments, the dial grip can be inwardly pushed by the patient applying an axial force to the rear end of the dial grip to inject the selected or set dose. In other embodiments, a separate button can be provided, which can be inwardly pushed by the patient applying an axial force to the rear end of the button to inject the selected or set dose. The dial grip can be particularly configured for releasable attachment to the drug injection device such that it can be replaced by another dial grip. The dial grip can be attached to a reusable injection device, such as Allstar. TMPens may include replaceable drug or medication cartridges, or disposable injection devices attached to a device containing a fixed amount of drug or medication, such as Solostar. TM The injection device can be transported, for example, with a simulated dial grip, which can be a passive dial grip, i.e., a grip without any special functions. A simulated dial grip can be understood herein as a dial grip that does not provide any function at all, or at least not any function other than basic functions (such as dose selection). It can specifically serve as a securing device for transporting the injection device. The simulated dial grip can be releasably attached to the injection device so that it can be replaced by another dial grip. The simulated dial grip can be extended with a grip top or replaced by a replacement dial grip, which includes special functions such as dose recording and connection features or other practical features. Such additional features for more comfortable operation of the dial grip can be attached to the simulated dial grip, for example, by a patient, to extend the basic functionality of the simulated dial grip.

[0005] In one aspect, this disclosure provides a dial grip for an injection device, the dial grip including a grip base, an operating portion disposed on one side of the grip base, and a coupling disposed on the other side of the grip base, the coupling being for engaging with a dose selection portion of a dose selection and dispensing mechanism of the injection device to connect the grip base to the dose selection and dispensing mechanism for selecting and dispensing a dose using the dial grip. The dial grip can, for example, be manufactured as a one-piece molded grip and can perform the basic functions of a simulated dial grip without any special functions. It can, for example, be used for transporting the injection device and for providing the patient with basic functions to select the dose to be injected by rotating the dial grip using the operating portion when the dial grip is attached to the injection device and to dispensing the selected dose by pushing the dial grip inward. The dial grip can be particularly configured for releasable attachment to the injection device so that it can be replaced by another dial grip that may include more functions.

[0006] In one embodiment, the dial grip may include at least one locking lever movable between a locked position and an unlocked position, wherein when moved to the locked position, the at least one locking lever is capable of engaging at least one locking lever receiver disposed within the body of the injection device. The locking lever may, for example, be configured to lock rotation of the dial grip when the dial grip is positioned on the injection device such that the locking lever is moved to the locked position. After positioning the dial grip to move the locking lever to the unlocked position, the dial grip can be rotated to allow dose selection. The term "locking lever" as used herein also includes locking bolts, locking pins, or locking arms.

[0007] In an implementation, the operating part can be configured to releasably attach to the top of the grip. Therefore, the operating part allows the top of the grip to be attached to and detached from the injection device, and thus extends the functionality of the dial grip, such as dose recording (when the top of the grip contains electronics provided and configured for this purpose). When the dial grip includes at least one locking lever, the dial grip can be configured to move the at least one locking lever between a locked position and an unlocked position depending on whether the grip top is attached to the operating part. For example, an injection device with an attached dial grip can be transported without an attached grip top, such that the at least one locking lever moves to the locked position and prevents the dial grip from being rotated to select a dose. When the grip top is attached to the dial grip, the at least one locking lever can move to the unlocked position, thereby allowing the dial grip to be rotated, and thus enabling the patient to use the injection device to select and dispense a dose.

[0008] In other embodiments, the operating portion of the dial grip may include a securing device for releasably attaching to the grip top. The grip top may be configured to further enhance the use of the dial grip, and in some embodiments, it may be necessary for the grip top to allow dose selection by rotating the dial grip. In particular, the grip top may provide additional functionality to the dial grip. The grip top may, for example, include electronics for providing additional functionality, may have a special shape or color to improve the use of the dial grip, and / or may include additional features useful to the patient.

[0009] In another embodiment, the securing device may include at least one guide groove, and the grip top may include one or more guide pins disposed therein for engaging with the at least one guide groove. The guide groove and guide pins allow the grip top to be securely secured to the operating part with moderate technical effort. In particular, the guide groove and guide pins may be molded together with the operating part and the grip top, respectively.

[0010] In another embodiment, the at least one guide slot may include an end section, and the fixing device may further include a retainer disposed in the end section, wherein the guide pin is capable of being disposed in the end section and releasably secured to the retainer in the end section. This allows the grip top to be more securely secured to the operating portion. In another embodiment, the fixing device may further include a retaining spring disposed in the operating portion to apply a force to the retainer. Therefore, in order to remove the dial top from the operating portion, the force applied by the retaining spring must be overcome, such that the force required to remove the grip top can be set by the retaining spring and the force it applies.

[0011] In an embodiment having a dial grip including at least one locking lever movable between a locked and unlocked position, the retaining spring can be arranged to force the at least one locking lever into the locked position when no guide pin is positioned in the end section. Therefore, the use of the dial grip, particularly its rotation for dose selection, is prevented when the grip top is not attached to the operating part; or in other words, dose selection can only be performed by rotating the dial grip when the grip top is attached.

[0012] In one embodiment, the grip base may further include a bushing arranged coaxially around the coupling and configured to insert between the dial sleeve of the dosage selection and dispensing mechanism and the body of the injection device. The bushing serves to align the dial grip with the injection device when attached. Furthermore, in addition to the coupling, the bushing can also increase the stability of the connection between the dial grip and the injection device.

[0013] In embodiments having a dial grip including at least one locking lever movable between a locked and unlocked position, the bushing may be configured as a guide for the at least one locking lever. This can be particularly useful when the at least one locking lever includes an extension that might make it difficult to attach the dial grip to the injection device. In this case, the bushing serving as a guide for the at least one locking lever can make it easier, for example, for a patient to attach the dial grip to the injection device. In particular, the at least one locking lever may include at least one stop bar, and the bushing may include a groove or channel provided in the bushing as a guide for the at least one locking lever.

[0014] On the other hand, this disclosure provides a replaceable grip top for a dial grip as disclosed herein, and the replaceable grip top includes at least one guide pin disposed therein for engaging at least one guide groove included in at least one guide groove of the operating portion of the dial grip. The grip top may be manufactured, for example, by molding, and the at least one guide pin may be molded therein. The grip top may be shaped for comfortable use by a patient, for example, including one or more handles to make rotation and dose selection easier for the user compared to a dial grip without a grip top.

[0015] In embodiments, the grip top as disclosed herein or the dial grip as disclosed herein may further include electronics configured to record, store, process, or transmit one or more drug doses selected and dispensed using an injection device. The electronics may be housed, for example, within the grip top, such as in a dedicated space below an end section of the grip top, such that when the grip top is attached to the operating part, the electronics are accommodated in the space between the end section of the grip top and the top side of the operating part. Other accommodating arrangements of the electronics within the grip top are also possible. The electronics may also be placed directly within the operating part, such as in a space provided for the electronics within the operating part.

[0016] In other embodiments of the grip top as disclosed herein or the dial grip as disclosed herein, the electronics may be configured to provide one or more of the following functions: Connection; Near Field Communication (NFC) connection; WiFi TM Connection. Therefore, the electronics can implement one or more connection features to the dial grip, thereby allowing data to be transmitted to and / or received from external devices such as a computer.

[0017] In another embodiment, the grip top or the dial grip as disclosed herein may include a battery, such as a button cell, as a power source for the electronics. The battery may be, in particular, a rechargeable battery, and contacts may be provided on the grip top and / or the outer side of the dial grip for charging the battery. For example, the grip top or the dial grip may be placed in a charging station, wherein charging contacts are arranged to contact the contacts on the grip top or the dial grip to supply charging current to the rechargeable battery. In a particular embodiment, the electronics may be configured for data communication via the charging contacts. Therefore, the charging station can serve as a docking station for charging and for data exchange between the electronics on the grip top or the dial grip and an external device communicatively connected to the charging station or docking station.

[0018] In another aspect, this disclosure provides an injection device comprising: a body housing a dose selection and dispensing mechanism having a mechanical interface at an open end of the body; and a dial grip as disclosed herein, wherein a coupling of the dial grip is connected to a dose selection portion of the dose selection and dispensing mechanism forming the mechanical interface to allow dose selection and dispensing using the dial grip. The dial grip may be, for example, an analog dial grip configured for transport without other functions, and an injection device having such an analog dial grip may be configured for dispensing purposes. The dial grip may be particularly releasably attached to the body of the injection device to allow replacement with another dial grip having different, particularly additional functions.

[0019] In other embodiments, the injection device may include a dial grip having other features as disclosed herein and / or a grip top having other features as disclosed herein.

[0020] According to one embodiment, this disclosure relates to an injection device comprising:

[0021] • The body, which is configured to house a dose selection and discharge mechanism, and

[0022] • A dial grip, wherein the dial grip is coupled to the dose selection and dispensing mechanism forming a mechanical interface to allow dose selection using the dial grip, wherein

[0023] The dial grip can be released from the dose selection and dispensing mechanism, allowing it to be replaced by a second dial grip, or the grip top of the dial grip can be released from the dial grip, allowing it to be replaced by a second grip top. The second dial grip / replacement dial grip or the second grip top / replacement grip top can provide additional features, such as connectivity features, for the user of the injection device.

[0024] The second dial grip or the top of the second grip may include electronics configured to perform at least one of the following: measuring, recording, storing, processing, and transmitting data related to the dosage of one or more drugs selected or dispensed using the injection device.

[0025] The electronic device can be configured to provide one or more of the following functions: Connection; Near Field Communication (NFC) connection; WiFi TM connect.

[0026] The second dial grip or the top of the second grip may also include a battery, particularly a rechargeable battery, as a power source for the electronics, and may include contacts disposed on the outside for charging the battery, wherein the electronics may be configured to perform data communication via the charging contacts.

[0027] The dial grip of the injection device according to this embodiment can be combined with other features disclosed in the specification. It may or may not have a grip base. It may or may not have a securing device for releasably attaching to the top of the grip. Attached Figure Description

[0028] Figure 1 shows an example of an injection pen with a simulated dial grip;

[0029] Figure 2 shows an example of a replaceable dial grip for an injection device in different views;

[0030] Figure 3 shows examples of the dial grip attached to the injection pen in different views; and

[0031] Figure 4 shows the guidance of the locking lever in an example of a dial grip from different views. Detailed Implementation

[0032] In the following description, embodiments of this disclosure will be referred to with reference to injection devices, particularly those in the form of a pen. However, this disclosure is not limited to such applications and can be equally well applied to other types of drug delivery devices, particularly those in a different shape than a pen.

[0033] Figure 1 illustrates an injection device in the form of an injection pen 50 having a body 52. ​​The body 52 is configured to hold a cartridge (not shown) and contain a dose selection and dispensing mechanism 56 (only the portion 56 for dose selection from said mechanism is shown in Figure 1). The body 52 has a proximal end and a distal end. A syringe 58, protected by a cap 60, is located at the proximal end of the body 52, and a simulated dial grip 10' is attached to the distal end of the body 52. ​​The simulated dial grip 10' can be releasably attached to the distal end and can provide basic functionality to the patient, as will be described below.

[0034] The patient can select a dose using the analog dial grip 10'. The selected dose is indicated on the scale of the dose selection and dispensing mechanism 56. Dose selection is possible only when the top of the grip is attached to the analog dial grip 10'. A locking lever prevents dose selection when the analog dial grip 10' is in a specific attachment position and / or when no grip top is attached to the analog dial grip 10'. Dose selection is typically performed by rotating the analog dial grip 10' relative to the body 52 about its longitudinal axis using the attached grip top. Rotating the analog dial grip 10' causes the dose selection and dispensing mechanism to bring the piston into a position where the selected dose can be dispensed from the cartridge within the body 52. ​​The selected dose can be dispensed by pressing the analog dial grip 10' downwards (i.e., in the axial direction toward the distal end of the body 52). The force applied to the analog dial grip 10' by pressing it down can be converted by the dose selection and dispensing mechanism into a pressure pulse acting on the cartridge (e.g., on the cartridge diaphragm), which increases the internal pressure of the cartridge and dispenses the amount of drug contained in the cartridge corresponding to the selected dose into the patient via syringe 58.

[0035] The analog dial grip 10' can be used to transport the injection pen 50 and can be provided or packaged with a simple grip top, thereby enabling dose selection and dispensing as described above. The simple grip top can be part of the analog dial grip 10' or it can be a separate part. If the simple grip top is implemented as a separate part, it can be replaced with another grip top to provide additional functionality to the injection pen 50. The analog dial grip 10' and the simple grip top can be implemented using relatively simple technical means, such as as a one-piece molded part, which can be shipped with the injection pen 50 to allow the patient to use the pen 50 immediately. When the patient desires more functionality, the analog dial grip 10' and / or the simple grip top can be replaced with a more complex dial grip or grip top, respectively. To achieve this, the analog dial grip 10' can be configured for releasable attachment to the injection pen 50 and / or releasable attachment to the grip top, thereby allowing for easy replacement of the grip top.

[0036] Figure 2 shows four different views from left to right of another dial grip 10 for an injection pen: a side view of the dial grip 10 with an attached grip top 28; a cross-section through the dial grip 10 with the attached grip top 28, showing the internal features of the attachment and locking lever 22 from the grip top 28 to the dial grip 10; a cross-section through the dial grip 10 with the grip top 28 removed, showing the internal features of the grip top 28 and the locking lever 22; and a side view of the dial grip 10 without the grip top 28, showing details of the guide groove 24 provided in the operating section 14 of the dial grip 10. This dial grip 10 is designed for a replaceable grip top 28 and can provide additional functionality for the patient, as described below. For example, it can be provided as a replacement for a dial grip if the patient desires, for example, more comfortable operation of the injection pen. However, in principle, the dial grip 10 can also be shipped as a simulated dial grip with the injection pen and can be extended using an attachable and replaceable grip top.

[0037] The rightmost figure in Figure 2 shows a side view of the dial grip 10: the grip base 12 forms the middle of the grip 10. The grip base 12 can be shaped like a coin, with a diameter similar to the diameter of the distal end of the injection pen, to which the dial grip 10 can be attached. The grip base 12 includes an operating side 16 and a lower side 20, which are arranged opposite each other like the two sides of a coin. The lower side 20 is configured to abut the distal end of the body 52 of the injection pen (as shown in Figure 3), and the operating side 16 is configured to attach the grip top 28 to the operating portion 14 protruding from the operating side 16.

[0038] An operating section 14 is disposed on the operating side 16. The operating section 14 may be formed as a cap extending from the operating side 16 of the grip base 12. The operating section 14 may be hollow to accommodate, for example, electronic components. One or more guide slots 24 may be disposed in the operating section 14, particularly in its sidewalls, as shown in the rightmost figure of FIG2. The guide slots 24 may be J-shaped, having an open entrance at one end of the J and an end section 25 extending from the other end of the J. The end section 25 may serve as a base for a guide pin 30 for the grip top 28. A retainer 26 is arranged in the end section 25 to releasably secure the guide pin 30 in the end section.

[0039] Specifically, a coupling 18, including one or more clamping legs, extends from the lower side 20 of the grip base 12. The coupling 18 is configured to engage with the dose selection portion of the injection pen's dose selection and dispensing mechanism, such that rotation of the dial grip 10 about its axis corresponding to the pen's axis causes rotation of the injection pen's dose selection and dispensing mechanism for selecting the desired dose to be dispensed. A bushing 13 is arranged coaxially around the coupling 18. During and while the dial grip 10 is attached to the injection pen, the bushing 13 can act as an aligner for the dial grip, as described later. Furthermore, the bushing 13 can act as a guide for one or more locking levers 22, again as described in detail later.

[0040] The leftmost figure in Figure 2 shows a side view of a dial grip 10 with an attached grip top 28. The grip top 28 may include a slotted or ribbed surface to facilitate rotation of the grip top 28. As shown in the two cross-sectional side views in Figure 2, the grip top 28 can be releasably attached to the dial grip 10.

[0041] As can be seen in the middle right figure, the grip top 28 includes a guide pin 30 disposed therein. When the grip top 28 is placed on the operating part 14, the guide pin 30 can engage with the guide groove 24. The guide pin 30 is arranged to mate with the guide groove 24 such that when the grip top 28 is placed on the operating part 14, the guide pin 30 can enter the entrance of the guide groove 24 and can be moved in the groove 26 to the end section 25 by rotating the grip top on the operating part 14 about the axis of the grip top 28 in a clockwise direction (or in a counterclockwise direction, depending on the arrangement of the guide groove 24). The guide pin 30 then stops at the left bottom of the J-shaped guide groove 24, i.e., the grip top 28 cannot be rotated further. The guide pin 30 can be forced into the end section 25 by slightly pushing the grip top 28 towards the grip base 12 in the axial direction on the dial grip 10. In the end section 25, the guide pin 30 can be locked by a retainer 26. The retainer 26 may be hook-like, such that inserting the guide pin 30 into the end section 25 may require less force than the force required to pull the guide pin 30 out of the end section 25.

[0042] The retainer 26 may be part of the locking lever 22, which may be implemented as a lever with one end extending from the pen-side end of the bushing 13 when the grip top 28 is not attached to the operating part 14 (as shown in the two right views of FIG. 2). Each locking lever 22 is guided by the bushing 22 and is movable between a locked position (shown in the two right views of FIG. 2) and an unlocked position (shown in the left view of FIG. 2). When the grip top 28 is fully attached to the operating part 14, each locking lever 22 moves to the unlocked position, meaning that the guide pin 20 of the grip top 28 latches in the end section 25 of the guide groove 24 and is held by the retainer 26. In this state, the guide pin 30 slightly lifts the retainer 26, causing the locking lever 22 to move from its locked position to its unlocked position.

[0043] The two intermediate views of Figure 2 also show that the grip top 28 and / or operating section 14 may include electronics 32, and particularly a rechargeable battery 34. Electronics 32 can be configured to record, store, process, or transmit at least one dose of one or more drugs selected and dispensed using the injection device 50. Furthermore, contacts 36 can be located on the outside of the grip top 28 and / or operating section 14. Contacts 36 can be configured to charge the battery 34, but can also be configured for data exchange between the electronics 32 and an external device. For example, contacts 36 can be electrically connected to corresponding contacts of a charging station (not shown), which can be connected to a computer via a data cable such as a USB (Universal Serial Bus) for powering charging and exchanging data between the computer and the electronics 32. Therefore, the grip top 28 or dial grip 10 can be connected to an external device for data exchange. However, electronics 32 can also be configured for wireless data exchange with an external device, for example by implementing… Connectivity, Near Field Communication (NFC) connectivity and / or WiFi TM The connection allows for wireless data exchange with external devices such as smartphones or tablet PCs. Contact 36 is optional and may only be provided when a rechargeable battery 34 is used. Alternatively, disposable batteries, such as button batteries, can be used.

[0044] Figure 3 shows a dial grip 10 attached to the distal end of the pen body 52. ​​The grip base 12 abuts the end of the sleeve of the body 52. ​​A bushing 13 aligns the attached dial grip 10 within the body sleeve 52. A coupling 18 of the dial grip 10 engages with a dose selection section 56 of the dose selection and dispensing mechanism, such that the coupling 18 and the dose selection section 56 are rotatably connected.

[0045] In the left view of Figure 3, the top 28 of the grip is not attached to the dial grip 10, causing the locking lever 22 to enter the locked position, i.e., one end protrudes from the pen side of the bushing 13. The protruding end of the locking lever 22 engages with a locking lever receiver 54 disposed inside the pen body sleeve 52. The locking lever receiver 54 can be implemented, for example, as a crown that prevents the dial grip 10 from rotating relative to the pen body sleeve 52, thus preventing the dosage selection unit 56 from rotating and making dosage selection impossible. Other embodiments of the locking lever 22 and the locking lever receiver 54 are possible, as long as the function of preventing the dial grip 10 from rotating relative to the pen body sleeve 52 is achieved when the top 28 of the grip is not attached to the dial grip 10.

[0046] The right side of Figure 3 shows the grip top 28 fully attached to and locked with the dial grip 10. In this state, the guide pin 30 is positioned in the end section 25 of the guide groove 24 (Figure 2), and the retainer 26 is raised at one end of the locking lever 22, so that the locking lever 22 is brought into the unlocked position, in which the locking lever is no longer engaged with the locking lever 54 inside the pen body sleeve 52. Therefore, it is possible to rotate the dial grip 10 relative to the pen body sleeve 52 using the attached grip top 28, and thus, the dosage can be selected by rotating the dosage selection section 56, which is rotatably connected to the coupling 18, along with the rotation of the dial grip 10.

[0047] As can be seen in Figure 3, the coupling 18 and the dosage selection unit 56 can be designed to engage with each other when the dial grip 10 is attached to the body 54 (i.e., when the bushing 13 is inserted into the body sleeve 54 until the grip base 12 abuts the end of the sleeve). This also allows the dial grip 10 to be removed from the pen body 54 by pulling it out of the body sleeve 54 with a force large enough to overcome the engaging force of both the coupling 18 and the dosage selection unit 56.

[0048] Figure 4 shows a partial cross-section of the guide ring 13 for the locking lever 22: the lever portion of the locking lever 22 is movably positioned in the channel 13' of the ring. Instead of the channel 13', a groove can also be used as a guide for the lever portion of the locking lever 22. A hook-like retainer 26 at the operating end of the locking lever 22 rests in the end section 25 of the guide groove 24. A retaining spring 27 is positioned above the retainer 26 in a seat within the operating section 14 and applies force to the retainer 26, thereby pressing the locking lever 22 downwards, causing the lower end of the locking lever 22 to disengage from the ring 13 and the channel 13' to engage with the locking lever receiving section 54 inside the body 52 of the injection pen (see Figure 3).

[0049] It should be noted that even if the retaining spring 27 is shown in an angular orientation, it can be arranged in another orientation, such as a radial orientation that pushes the retainer outward.

[0050] It should also be noted that another arrangement of the locking lever 22 is also possible, such as a hinge lever, as long as braking is achieved between the pen body 52 and the dial grip 10 when the top of the grip 28 is removed.

[0051] The right-hand view of Figure 4 shows the state in which the guide pin 30 rests in the end section 25 of the guide groove 24 when the grip top 28 is fully attached to the dial grip 10 (as shown in the right-hand view of Figure 3). The guide pin 30 is held in its position in the end section 25 by the retainer 26, and the retainer 25 is pressed upward by the guide pin 30 against the force of the retaining spring 27. This also causes the locking lever 22 to move upward so that it rests fully in the channel 13', and no part of the locking lever 22 will disengage from the bushing 13 with its bottom. In this state, the dial grip 10, together with the fully attached grip top 28, is able to rotate relative to the body 52 of the injection pen about its longitudinal axis, and the movable coupling 18 can move the rotatably connected dose selection section 56 for dose selection.

[0052] By pulling the top of the grip 28 slightly away from the grip base 12 in the axial direction, causing the guide pin 30 to move beyond the end section 25 (which requires a greater force than the retaining spring 27 is applying to the retainer 26), the top of the grip can be removed from the dial grip 10. Once the guide pin 30 is beyond the end section 25, the retaining spring 27 can unfold and force the retainer 26 and locking lever 22 downward (as shown in the left view of FIG4), thus preventing relative movement of the dial grip 10 relative to the body 52 of the syringe pen, and further manipulation of the top of the grip 28 will not result in unintentional dose selection or ejection. Then, as the guide pin 30 can be moved beyond the end section 25, the top of the grip 28 can be rotated counterclockwise to move the guide 30 into a section of the guide groove 24 that is substantially parallel to the grip base 12, until the guide pin 30 abuts the axial section of the guide groove 24 that is open at the top of the operating section 14. Finally, the grip top can be removed by axially pulling the grip top 28 away from the operating part 14 of the dial grip 10.

[0053] The dial grip 10 can be removed from the body 52 of the injection pen by rotating the dial grip 10 to the 0IU stop of the dosage selection and dispensing mechanism of the injection pen, then pulling the dial grip 10 axially outward and further twisting the dial grip 10 (beyond the 0IU stop, where the pen's mechanism stops at 0IU). Finally, the dial grip 10 can be removed from the body 52 by pulling it axially away. This can be performed to replace, for example, an analog dial grip with a dial grip that includes additional functions (such as electronics).

[0054] The terms “drug” or “pharmaceutical” are used synonymously herein and describe pharmaceutical preparations containing one or more active pharmaceutical ingredients (APIs) or pharmaceutically acceptable salts or solvates thereof, and optionally pharmaceutically acceptable carriers. In the broadest sense, an active pharmaceutical ingredient (“API”) is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or pharmaceutical preparation is used to treat, cure, prevent, or diagnose a disease, or to otherwise enhance physical or mental health. Drugs or pharmaceutical preparations may be used for a limited duration or periodically for chronic disorders.

[0055] As described below, a drug or pharmaceutical preparation may include at least one API or 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; 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 may be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). Mixtures of one or more drugs are also contemplated.

[0056] The drug or pharmaceutical preparation may be contained in a primary encapsulation or "drug container" adapted for use with a drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other robust or flexible vessel configured to provide a suitable chamber for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chamber may be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chamber may be designed to store the drug for about one month to about two years. Storage may occur at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the drug container may be or may include a dual-chamber cartridge configured to separately store two or more components (e.g., API and diluent, or two different drugs) of a drug formulation to be administered, one component in each chamber. In this case, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components before and / or during administration to a human or animal. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., through a conduit between the two chambers), and allow the user to mix the two components when needed before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing during dispensing of the components into a human or animal body.

[0057] Drugs or agents contained in drug delivery devices as described herein can be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes or diabetes-related complications (such as diabetic retinopathy), thromboembolic disorders (such as deep vein or pulmonary thromboembolism). Other examples of disorders are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those described in the following manuals: such as Rote Liste 2014 (e.g., but not limited to, main group 12 (antidiabetic drugs) or 86 (oncology drugs)) and Merck Index, 15th edition.

[0058] Examples of APIs used to treat and / or prevent type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide-1 (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture thereof. As used herein, the terms “analyte” and “derivative” refer to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deletion and / or exchange of at least one amino acid residue present in a naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues may be encoding amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. Specifically, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in a naturally occurring peptide may have been deleted and / or substituted with other amino acids (including non-coding amino acids), or amino acids (including non-coding amino acids) may have been added to a naturally occurring peptide.

[0059] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (glargine insulin); Lys(B3), Glu(B29) human insulin (glutamate insulin); Lys(B28), Pro(B29) human insulin (lispro insulin); Asp(B28) human insulin (aspart insulin); human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala, and in which Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0060] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (detemir insulin, 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-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (degludecinin, ); B29-N-(N-lithochyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0061] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixilatin. Exenatide (Exendin-4, Liraglutide, a 39-amino acid peptide produced by the salivary glands of the Gila monster. Semaglutide, Taspoglutide, Albiglutide Dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langnatide / HM-11260C, CM-3, GLP-1Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexen, Viador-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.

[0062] Examples of oligonucleotides include, for instance, sodium mipronil. It is a cholesterol-reducing antisense agent used to treat familial hypercholesterolemia.

[0063] Examples of DPP4 inhibitors include vedagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0064] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, fertility-stimulating hormone), growth hormone (growth hormone), desmopressin, terlipressin, gosorelin, triptorelin, leuprorelin, buserorelin, nafarelin, and goserelin.

[0065] Examples of polysaccharides include glucosaminoglycane, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20. It is a type of sodium hyaluronate.

[0066] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigens. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, whole-human antibodies, non-human antibodies (e.g., mouse antibodies), or single-chain antibodies. In some embodiments, antibodies have effector function and can fix complement. In some embodiments, antibodies have reduced or no ability to bind Fc receptors. For example, antibodies can be isotypes or subtypes that do not support binding to Fc receptors, antibody fragments, or mutants, for example, having a mutagenic or missing 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 cross-binding region orientation.

[0067] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule, which does not include full-length antibody polypeptides but still includes at least a portion of a full-length antibody polypeptide capable of binding antigens. Antibody fragments may include cleaved portions of full-length antibody polypeptides, although the term is not limited to such cleaved fragments. Antibody fragments that can be used in this invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (such as bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., double-chain, triple-chain, and quadruple-chain antibodies)), monovalent or multivalent antibody fragments (such as bivalent, trivalent, quadruvalent, and multivalent antibodies), microantibodies, chelated recombinant antibodies, tri- or bivalent antibodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camel-derived antibodies, and antibodies containing VHH. Further examples of antigen-binding antibody fragments are known in the art.

[0068] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term "frame region" refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides; it is not a CDR sequence and is primarily responsible for maintaining the correct positioning of the CDR sequence to allow antigen binding. Although the frame region itself typically does not directly participate in antigen binding, as is known in the art, certain residues within the frame region of some antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0069] 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).

[0070] Pharmaceutically acceptable salts of any API described herein are also intended for use in drugs or pharmaceutical preparations in drug delivery devices. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0071] Those skilled in the art will understand that various modifications (additions and / or removals) can be made to various components of the APIs, formulations, devices, methods, systems, and embodiments described herein without departing from the full scope and spirit of the invention, which covers such modifications and any and all equivalents thereof.

Claims

1. A dial grip (10) for an injection device (50), comprising: - Grip base (12). - An operating part (14) is provided on one side (16) of the grip base (12), and - A coupling (18) disposed on the other side (20) of the grip base (12), the coupling being for engaging with the dose selection section of the dose selection and dispensing mechanism of the injection device, to connect the grip base (12) to the dose selection and dispensing mechanism for selecting the dose using the dial grip (10), The dial grip (10) includes at least one locking lever (22) movable between a locked position and an unlocked position, wherein when moved to the locked position, the at least one locking lever (22) is capable of engaging with a locking lever receiver (54) disposed within the body (52) of the injection device (50) to lock rotation of the dial grip. The grip base (12) further includes a bushing (13) arranged coaxially around the coupling (18) and configured for insertion into the body of the injection device. The bushing (13) is configured as a guide for the at least one locking lever. The operating part (14) is configured for releasably attaching to the grip top (28) and includes at least one guide groove (24). The grip top (28) includes one or more guide pins (30) disposed on its inner side for engaging with the at least one guide groove (24), wherein the at least one guide groove (24) includes an end section (25), and each of the at least one locking lever (22) includes a retainer (26) located in the end section (25), wherein the guide pin (30) is configured to be disposed in the end section (25) and releasably secured in the end section (25) with the retainer (26) such that the locking lever moves from a locked position to an unlocked position.

2. The dial grip (10) according to claim 1 further includes a retaining spring (27) arranged in the operating part (14) to apply force to the retainer (26), the retaining spring (27) being arranged to force the locking lever (22) into the locked position when no guide pin (30) is placed in the end section (25).

3. The dial grip (10) according to claim 1 or 2, wherein the grip top (28) further includes an electronic device (32) configured to record, store, process, or transmit at least one of the following: doses of one or more drugs selected and dispensed using the injection device (50).

4. The dial grip (10) of claim 3, wherein the electronics (32) is configured to provide one or more of the following functions: Bluetooth® connectivity; near field communication connectivity; WiFi™ connectivity.

5. The dial grip (10) according to claim 3, wherein the grip top (28) further includes a battery (34) as a power source for the electronic device, wherein the battery (34) is a rechargeable battery, and charging contacts (36) disposed on the outside for charging the battery (34), wherein the electronic device (32) is specifically configured for data communication via the charging contacts (36).

6. An injection device comprising: • Body (52), the body being configured to house a dose selection and discharge mechanism, and • The dial grip (10) according to claim 1 or 2, wherein the dial grip (10) is coupled to the dose selection and dispensing mechanism forming a mechanical interface to allow dose selection using the dial grip (10). in The dial grip (10) can be released from the dosage selection and dispensing mechanism, allowing the dial grip (10) to be replaced by a second dial grip, or The grip top (28) of the dial grip can be released from the dial grip so that it can be replaced by the second grip top. And among them, The body (52) includes a locking lever receiver (54) configured to engage with the locking lever (22) when at least one locking lever (22) of the dial grip (10) is moved to the locked position to lock the rotation of the dial grip.

7. The injection device according to claim 6, characterized in that... The second dial grip or the top of the second grip includes an electronic device (32) configured to perform at least one of the following: measuring, recording, storing, processing, or transmitting data related to the dosage of one or more drugs selected or dispensed using the injection device (50).

8. The injection device (50) according to claim 6 or 7, wherein The dose selection and discharge mechanism includes a dose selection section (56) on an open end of the body (52), and The coupling (18) of the dial grip (10) can engage with the dose selection section (56) of the dose selection and dispensing mechanism that forms the mechanical interface, so as to allow dose selection and dispensing using the dial grip (10).

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