Syringe device

Abstract

An injector device (20) comprising an elongated housing (11) having a proximal end (P) and a distal end (D) and configured to receive a medicament container (18), a plunger rod (21) longitudinally movable within the housing between a cocked position and a completed position, the plunger rod being configured to be engageable with the medicament container when received in the housing, wherein the housing comprises an indicator (24) located in a proximal region (P') of the housing, the indicator comprising a display window (25) located in a proximal region (P') of a side wall of the housing, a proximally extending protrusion (30) extending from the plunger rod (21), wherein the protrusion is coupled to the plunger rod, the protrusion being visible through the display window in at least the cocked position, the protrusion being configured to move between a first indicator position and a second indicator position, thereby providing information to a user associated with a progress of an injection process depending on a longitudinal position of the plunger rod.

Description

Technical Field

[0001] This invention relates to a syringe device for pharmaceutical preparations. Background Technology

[0002] Injection devices (e.g., autoinjectors) typically have a sealed drug container and a needle for injecting a drug into a patient. In one type of device, the drug container may include a drug cartridge, and the needle is initially detachable from the cartridge. An initial operation moves the cartridge and needle together, causing the needle to pierce the cartridge. In another type of device, the drug container may include an injection cartridge containing the drug, and the needle may be secured to the injection cartridge. In both cases, a plunger or piston within the cartridge or injection cartridge can then be moved into the cartridge or injection cartridge to dispense the drug through the needle for injection into the patient. Summary of the Invention

[0003] The object of the present invention is to provide an advantageous syringe device comprising: an elongated housing having a proximal end and a distal end and configured to receive a drug container; a plunger rod longitudinally movable within the housing between a ready-to-launch position and a completed position, the plunger rod being configured to engage with the drug container when received within the housing, wherein the housing includes an indicator located in a proximal region of the housing, the indicator including a display window located in a proximal region of a sidewall of the housing, and a proximal protrusion extending from the plunger rod, wherein the protrusion is coupled to the plunger rod, the protrusion being visible through the display window at least in the ready-to-launch position, the protrusion being configured to move between a first indicator position and a second indicator position, thereby providing the user with information associated with the progress of the injection process depending on the longitudinal position of the plunger rod.

[0004] Preferably, the distal end of the shell is relatively closer to the injection site, and the proximal end is relatively farther away from the injection site.

[0005] The indicator may further include an indicator element, the protrusion of which is located between the display window and the indicator element in at least the ready position to obscure the user's view of the indicator element.

[0006] The protrusion can be axially coupled to the plunger rod and is configured to move between a first indicated position and a second indicated position when the plunger rod moves from the ready position to the completed position, wherein the movement of the protrusion toward the second indicated position makes a larger portion of the indicated element visible through the display window.

[0007] When the protrusion is in the first indicated position, the proximal end of the protrusion is preferably located at the proximal end of the display window.

[0008] In one implementation, when the protrusion is in the first indicated position, only the protrusion may be visible through the display window.

[0009] When the protrusion is in the second indicated position, the proximal end of the protrusion is preferably located at the far end of the display window.

[0010] In one implementation, when the protrusion is in the second indicating position, only the indicating element may be visible in the display window.

[0011] Preferably, the protrusion is rotatably disengaged from the plunger rod, so that the protrusion remains aligned with the display window throughout the injection process.

[0012] The inner surface of the housing may include a guide mechanism configured to restrict rotational movement of the protrusion about the longitudinal axis of the plunger rod.

[0013] In some embodiments, the housing may further include a second indicator comprising a display window in a distal region of the housing, the pharmaceutical container being visible through the second display window when the plunger rod is in its ready-to-fire position and when the pharmaceutical container is received in the housing, and wherein the distal end of the plunger rod is located at the distal end of the second window when the plunger rod is moved longitudinally to the finished position.

[0014] In one embodiment, the plunger rod and the indicating element may include the same markings, and the protrusion may include markings different from those on the plunger rod and the indicating element.

[0015] In other embodiments, the plunger rod and the protrusion may include the same markings, and the indicating element may include markings different from those on the plunger rod and the protrusion.

[0016] In some embodiments, the syringe device may further include an outer sleeve configured to extend around the housing, the outer sleeve being longitudinally movable from a first position at the proximal end of the housing to a second position at the distal end of the housing, in the first position the outer sleeve covers the indicator and in the second position the outer sleeve exposes the indicator.

[0017] The syringe device may further include a pharmaceutical container received within the housing between the plunger rod and the distal end of the syringe device.

[0018] The indicator may include a spindle, which includes a shaft and a dial, wherein the dial is configured to rotate to provide the user with information related to the progress of the injection process, depending on the longitudinal position of the plunger rod.

[0019] The spindle can be restricted to not moving in the longitudinal direction, but can rotate relative to the plunger rod.

[0020] The housing can prevent the spindle from moving in the longitudinal direction.

[0021] The dial can be located at the proximal end of the housing such that the distal surface of the dial contacts the proximal end of the housing, and the proximal surface of the dial faces the outside of the device, so as to provide the user with information related to the progress of the injection process during use.

[0022] The dial can be located inside the housing at the proximal end of the housing, with the proximal surface of the dial facing outwards to provide the user with information related to the progress of the injection process.

[0023] The proximal surface of the dial may include a surface structure configured to provide the user with tactile feedback associated with the progress of the injection process.

[0024] The housing may include a cover extending from the proximal end of the housing and on the proximal surface of the dial, the cover being configured such that the dial can provide the user with visual feedback associated with the progress of the injection process.

[0025] The dial can be housed within the proximal end of the housing, and the housing further includes a display window on its side through which the side of the dial can be seen. The side of the dial includes markings configured to provide the user with visual feedback associated with the progress of the injection process.

[0026] The spindle shaft may include a threaded arrangement configured to engage with a threaded arrangement on a plunger rod, such that longitudinal movement of the plunger rod from a ready position toward a finished position is configured to cause rotation of the spindle dial.

[0027] The threaded arrangement may include a continuous thread on at least one of the shafts of the plunger rod and the mandrel, the continuous thread being configured to provide continuous feedback on the progress of the injection process.

[0028] The thread arrangement may include discontinuous threads on one of the shafts of the plunger rod and the mandrel, the discontinuous threads being configured to provide event-specific feedback on the progress of the injection process.

[0029] The plunger rod may be hollow and include an open proximal end of a shaft configured to receive a mandrel. The plunger rod includes threads on its inner surface, and the shaft includes threads on its outer surface.

[0030] Another object of the present invention is to provide a method of using a syringe device, the method comprising: actuating the syringe device such that a plunger rod moves longitudinally within a housing from a ready-to-fire position to a completed position; and providing information associated with the longitudinal position of the plunger rod using an indicator.

[0031] These and other aspects of the invention will become clear and elucidated with reference to the embodiments described below. Attached Figure Description

[0032] Embodiments of the invention will now be described by way of example only with reference to the accompanying drawings, in which:

[0033] Figure 1A is a schematic side view of the removable cap and the syringe device embodying the present invention;

[0034] Figure 1B is a schematic side view of the syringe device of Figure 1A with the cap removed from the housing;

[0035] Figure 2 is a perspective view of the syringe device according to the present invention in its ready-to-fire position;

[0036] Figure 3 is a schematic perspective view of the syringe device in Figure 2 in its completed position;

[0037] Figure 4 is a schematic side view of the syringe device of Figure 2 being held in use;

[0038] Figure 5 is a schematic side view of the syringe device of Figure 2, which further includes an outer sleeve that is held at the start of the injection process.

[0039] Figure 6 is a schematic side view of the syringe device of Figure 5 being held during injection;

[0040] Figure 7 is a schematic cross-sectional view of the syringe device according to the present invention in its ready-to-fire position;

[0041] Figure 8 is a schematic cross-sectional view of the syringe device of Figure 7, in which the plunger rod has been moved toward the finished position;

[0042] Figure 9 is a schematic cross-sectional view of an alternative arrangement of the dial at the proximal end of the syringe device in Figure 7;

[0043] Figure 10 is a schematic cross-sectional view of an alternative arrangement of the dial at the proximal end of the syringe device in Figure 7.

[0044] Figure 11 shows a set of embodiments of the markings on the dial arrangement of the syringe device of Figure 7;

[0045] Figure 12 shows a schematic cross-sectional view of the alternative threaded engagement of the syringe device of Figure 7; and

[0046] Figure 13 shows a schematic cross-sectional view of an alternative arrangement of the plunger rod and mandrel of the syringe assembly of Figure 7. Detailed Implementation

[0047] As described herein, drug delivery devices can be configured to inject medication into a patient. Delivery can be subcutaneous, intramuscular, or intravenous. Such devices can be operated by a patient or caregiver (such as a nurse or physician) and can include various types of safety syringes, pen syringes, or auto-injectors. The devices may include cartridge-based systems that require piercing a sealed ampoule before use. The volume of medication delivered using these different devices can range from about 0.5 ml to about 3 ml. Another device may include a high-volume device (“LVD”) or patch pump configured to adhere to the patient’s skin for 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 50 ml). Yet another device may include a pre-filled syringe within the device’s housing. The syringe may be fixed within the housing or may be movable within the housing, for example, from a retracted position to an extended operating position.

[0048] In combination with specific medications, the devices described herein can also be customized to operate within required specifications. For example, a device can be customized to inject the medication over a specific time period (e.g., approximately 3 seconds to approximately 20 seconds for an autoinjector and approximately 10 minutes to approximately 60 minutes for an LVD). Other specifications may include low or minimal levels of discomfort, or certain conditions related to human factors, shelf life, expiration date, biocompatibility, environmental factors, etc. This variation can arise from various factors (e.g., the viscosity of the medication ranges from approximately 3 cP to approximately 50 cP). Therefore, medication delivery devices will typically include hollow needles ranging in size from approximately 25 to approximately 31 gauges. Common sizes are gauges 17 and 29.

[0049] The delivery device described herein may also include one or more automated functions. For example, one or more of the following may be automated: needle and cartridge assembly, needle insertion, drug injection, and needle retraction. Energy for one or more automated steps may be provided by one or more energy sources. Energy sources may include, for example, mechanical energy, pneumatic energy, chemical energy, or electrical energy. For example, a mechanical energy source may include a spring, lever, elastomer, or other mechanical mechanism that stores or releases energy. One or more energy sources may be combined into a single device. The device may further include gears, valves, or other mechanisms that convert energy into movement of one or more components of the device.

[0050] One or more automated functions of an autoinjector can be activated individually via an activation mechanism. This activation mechanism may include actuators, such as buttons, levers, needle sleeves, or other activating components. Activation of an automated function can be a one-step or multi-step process. That is, a user may need to activate one or more activation components to produce the automated function. For example, in a one-step process, a user may press the needle sleeve against their body to induce injection of a drug. Other devices may require multi-step activation of the automated function. For example, a user may need to press a button and retract the needle sheath to induce injection.

[0051] Furthermore, activation of one automated function can activate one or more subsequent automated functions, thus forming an activation sequence. For example, activation of the first automated function can activate at least two of the following: needle and cartridge assembly, needle insertion, drug injection, and needle retraction. Some devices may also require a specific sequence of steps to cause the one or more automated functions to occur. Other devices may operate in a series of independent steps.

[0052] Some delivery devices may include one or more functions of a safety syringe, pen syringe, or autoinjector. For example, a delivery device may include a mechanical power source configured to automatically inject the drug (as typically found in autoinjectors) and a dosage setting mechanism (as typically found in pen syringes).

[0053] According to some embodiments of this disclosure, an exemplary drug delivery device 10 is shown in Figures 1A and 1B. As described above, device 10 is configured to inject a drug into a patient. Device 10 includes a housing 11 that typically contains a cartridge or pre-filled syringe defining a reservoir for containing the drug to be injected, and components necessary to facilitate one or more steps of the delivery process.

[0054] The device 10 may also include a cap 12 that can be detachably mounted to the housing 11. Typically, the user must remove the cap 12 from the housing 11 before the device 10 can be operated.

[0055] As shown in the figure, the shell 11 is substantially cylindrical and has a substantially constant diameter along the longitudinal axis AA. The shell 11 has a distal region D and a proximal region P. The term "distal" refers to a position relatively closer to the injection site, and the term "proximal" refers to a position relatively farther from the injection site.

[0056] The device 10 may also include a needle sleeve 19 coupled to the housing 11 to allow movement of the sleeve 19 relative to the housing 11. For example, the sleeve 19 may be movable in a longitudinal direction parallel to the longitudinal axis AA. Specifically, movement of the sleeve 19 in the proximal direction may allow the needle 17 to extend from the distal region D of the housing 11.

[0057] Insertion of the needle 17 can occur via several mechanisms. For example, the needle 17 can be fixedly positioned relative to the housing 11 and initially located within the extended needle sleeve 19. Proximal movement of the sleeve 19, by placing the distal end of the sleeve 19 against the patient's body and moving the housing 11 in a distal direction, exposes the distal end of the needle 17. This relative movement allows the distal end of the needle 17 to extend into the patient's body. This type of insertion is referred to as "manual" insertion because the needle 17 is manually inserted by the patient manually moving the housing 11 relative to the sleeve 19.

[0058] Another form of insertion is "automatic," whereby the pin 17 moves relative to the housing 11. This insertion can be triggered by movement of the sleeve 19 or by another form of activation (such as, for example, button 13). As shown in Figures 1A and 1B, button 13 is located at the proximal end of the housing 11. However, in other embodiments, button 13 may be located on one side of the housing 11.

[0059] Other manual or automated features may include drug injection or needle retraction, or both. Injection is the process of moving the stopper or piston 14 from a proximal position to a more distal position within the reservoir of cartridge 18 to force the medication from cartridge 18 through needle 17. In some embodiments, a drive spring (not shown) is compressed before device 10 is activated. The proximal end of the drive spring may be fixed within the proximal region P of housing 11, and the distal end of the drive spring may be configured to apply a compressive force to the proximal surface of piston 14. Upon activation, at least a portion of the energy stored in the drive spring may be applied to the proximal surface of piston 14. This compressive force may act on piston 14 to move it in a distal direction. This distal movement acts to compress the liquid medication within cartridge 18, thereby forcing it out of needle 17.

[0060] After injection, the needle 17 can retract into the sleeve 19 or the housing 11. Retraction can occur as the user removes the device 10 from the patient's body, when the sleeve 19 moves distally. This can happen while the needle 17 remains fixedly positioned relative to the housing 11. Once the distal end of the sleeve 19 has moved past the distal end of the needle 17 and the needle 17 is covered, the sleeve 19 can be locked. This locking can include locking any proximal movement of the sleeve 19 relative to the housing 11.

[0061] Another form of needle retraction can occur if the needle 17 moves relative to the housing 11. This movement can occur if the cartridge 18 within the housing 11 moves proximally relative to the housing 11. This proximal movement can be achieved using a return spring (not shown) located in the distal region D. The compressed return spring, when activated, can provide sufficient force to the cartridge 18 to move it proximally. After full retraction, any relative movement between the needle 17 and the housing 11 can be locked by a locking mechanism. Additionally, the button 13 or other components of the device 10 can be locked as needed.

[0062] Referring now to FIG2, an embodiment of the syringe device 20 of the present invention is shown. The syringe device 20 of the present invention is similar to the device 10 described above, and therefore the features and components of the device 20 that are the same as those of the device 10 described above will retain the same terms and reference numerals.

[0063] The syringe device 20 includes a housing 11 configured to receive a drug container 18, i.e., a cartridge. The drug container 18 can refer to a container for receiving a drug or a container at least partially filled with a drug. The housing 11 is elongated and includes a proximal end P and a distal end D. The drug container 18 is received in the distal region D' of the housing 11. That is, the drug container 18 is positioned closer to the distal end D of the housing 11 than to the proximal end P of the housing 11.

[0064] For the purposes described below, the distal region D' can be considered as part of the housing 11, which is closer to the distal end D of the housing 11 than to the proximal end P of the housing 11. The proximal region P' of the housing 11 can be considered as part of the housing 11, which is closer to the proximal end P of the housing 11 than to the distal end D of the housing 11.

[0065] In Figures 2 and 3, the housing 11 of the syringe device 20 is shown partially transparently to provide a clearer view of the internal components of the syringe device 20. For clarity, some components of the syringe device 20 are not shown in Figures 2 and 3 (such as the cap 12 and the needle sleeve 19) for the sake of simplicity.

[0066] The syringe device 20 further includes a plunger rod 21, which is longitudinally movable within the housing 11 between a ready-to-fire position (shown in FIG. 2) and a finished position (shown in FIG. 3). Preferably, the plunger rod 21, when in its ready-to-fire position (in some cases not fully), is primarily located in the proximal region P', and when in its finished position, it is primarily located in the distal region D'. Thus, the plunger rod 21 can move from the proximal region P' of the housing 11 to the distal region D' of the housing 11 during the injection process. In any case, when the plunger rod 21 is in its finished position, it is positioned closer to the distal end D of the housing 11 compared to when it is in its ready-to-fire position.

[0067] The syringe device 20 further includes a drug container 18. The plunger rod 21 includes a distal end 22 and a proximal end 23. The drug container 18 is received within the housing 11 between the plunger rod 21 and the distal end D of the syringe device 20.

[0068] The plunger rod 21 includes a stopper 14 located at its distal end 22. The stopper 14 is configured to contact the sidewall(s) of the medication container 18 to form a seal, such that when the plunger rod 21 is moved longitudinally in the distal direction from the ready position toward the distal position, the medication is ejected from the container 18 and passes through the needle 17.

[0069] The syringe device 20 further includes an indicator 24. The indicator 24 is located in a proximal region P' of the housing 11. Preferably, the indicator 24 is located in a region proximal to P. That is, preferably, the indicator 24 is positioned close to (in cases where not located at the proximal end) the proximal end P of the housing 11. The indicator 24 is configured to provide the user with information related to the progress of the injection process, depending on the longitudinal position of the plunger rod between the ready and finished positions.

[0070] In this embodiment, the indicator 24 includes a display window 25. The display window 25 is located in the sidewall of the housing 11. The display window 25 includes a distal end 28a and a proximal end 28b. The display window 25 is located in the proximal region P' of the housing 11. Preferably, the display window 25 is entirely located in the proximal region P' of the housing 11. Even more preferably, the display window is positioned close to the proximal end P of the housing 11. That is, preferably, the proximal end 28b of the display window 25 is located near the proximal end P of the housing 11. Positioning the display window 25 near the proximal end P of the housing 11 allows the user to grip the syringe device 20 closer to the distal end D of the housing 11, which improves the stability of the device 20 during injection because the user's hand is closer to the injection site. The display window 25, positioned near the proximal end P of the housing 11, also allows the user to grip the device 20 close to its distal end D, while still allowing the user to see the indicator 24 and information associated with the progress of the injection process, as shown in FIG4.

[0071] In Figures 2 and 3, the display window 25 is shown as a rectangular aperture 27 in the sidewall of the housing 11. The display window 25 has its longitudinal axis extending parallel to the longitudinal axis of the housing 11. The longitudinal length of the display window 25 (i.e., the distance between the distal end 28a and the proximal end 28b) is substantially equal to the longitudinal distance that the plunger rod 21 must travel between its ready position and its finished position.

[0072] It will be understood that the display window 25 can be any other shape, including but not limited to triangles, circles, or curves. Furthermore, it will be understood that more than one display window 25 may be located in the sidewall of the housing 11, preferably spaced apart by longitudinal gaps. The display window 25 may include a cover 29 configured to prevent debris from entering the housing 11 of the injection device 20. The cover 29 may be configured to allow a user to see through the display window 25 and into the device 20. That is, the cover may be transparent or translucent.

[0073] The indicator 24 further includes a proximal protrusion 30. The protrusion 30 includes a distal end 31 and a proximal end 32. The protrusion 30 is connected to the plunger rod 21 and extends proximally away from the plunger rod 21. Preferably, the distal end 31 of the protrusion 30 is connected to the plunger rod 21. The protrusion 30 is configured to be visible through the display window 25 when the plunger rod 21 is at least in its ready-to-fire position.

[0074] The protrusion 30 includes an outward-facing surface 33 configured to be viewed through the display window 25 when the plunger rod 21 is at least in its ready-to-fire position. The outward-facing surface 33 is located on a longitudinally projecting arm 34 of the protrusion. Preferably, the distal end 31 of the protrusion 30 is connected to the plunger rod 21 in a proximal region (i.e., near the proximal end 23 of the plunger rod 21). The distal end 31 of the protrusion 30 may include a flange 35 connecting the distal end 31 of the arm 34 of the protrusion 30 to the proximal region of the plunger rod 21.

[0075] As shown in Figure 2, the protrusion 30 extends in the proximal direction such that most of the protrusion 30 is positioned further away from the distal end D of the housing 11 rather than the proximal end of the plunger rod 21. That is, the proximal end 32 of the arm 35 of the protrusion 30 is spaced apart from the proximal end 23 of the plunger rod 21 and is positioned closer to the proximal end P of the housing 11.

[0076] The syringe device 24 further includes an indicator element 36. The indicator element 36 is located at the same longitudinal position as the display window 25. In some embodiments, the area covered by the indicator element 36 may be slightly larger than the area of ​​the display window 25. The indicator element 36 is also located radially inward of the display window 25 and the arm 34 of the protrusion 30 extending from the plunger rod 21. The arm 34 of the protrusion 30 is located between the display window 25 and the indicator element 36. The arm 34 of the protrusion 30 is configured to obstruct the user's view of the indicator element 36 when the plunger rod 21 is at least in its ready-to-fire position.

[0077] The protrusion 30 is axially connected to the plunger rod 21. The protrusion 30 is configured to move between a first indicating position A (shown in Figure 2) and a second indicating position B (shown in Figure 3) as the plunger rod 21 moves from a ready position (shown in Figure 2) to a completed position (shown in Figure 3). Therefore, the longitudinal movement of the plunger rod 21 causes the protrusion 30 to move by the same amount in the longitudinal direction. Furthermore, the movement of the protrusion 30 from the first indicating position A toward the second indicating position B makes a larger portion of the indicating element 36 visible through the display window 25.

[0078] In one embodiment, when the protrusion 30 is in the first indicated position A, as shown in FIG2, the proximal end 32 of the arm 34 of the protrusion 30 is located at the proximal end 28b of the display window 25. In such an embodiment, most of the indicating element 36 can be obscured by the arm 34 of the protrusion 30 and cannot be seen through the display window 25, indicating that the plunger rod 21 is in its ready-to-fire position. In another embodiment, when the protrusion 30 is in the first indicated position A, only the arm 34 of the protrusion 30 is visible through the display window 25, indicating that the plunger rod 21 is in its ready-to-fire position.

[0079] In one embodiment, when the protrusion 30 is in the second indicating position B, the proximal end 32 of the protrusion 30 is located at the distal end 28a of the display window 25. In such an embodiment, most of the indicating element 36 is visible through the display window 25. That is, when the protrusion 30 is in the second indicating position B to indicate that the plunger 21 is in its completed position, only a small portion of the indicating element 36 is obscured by the arm 34 of the protrusion 30 and cannot be viewed through the display window. In another embodiment, when the protrusion 30 is in the second indicating position B, only the indicating element 36 is visible through the display window 25 to indicate that the plunger 21 is in its completed position, as shown in FIG3. That is, when the protrusion 30 is in its second indicating position B, the arm 34 of the protrusion 30 is not visible through the display window 25.

[0080] In one embodiment, the plunger rod 21 can be restricted to purely longitudinal movement. In such an embodiment, the protrusion 30 can be integrally formed with the plunger rod 21. Alternatively, the protrusion 30 can be fixedly attached to the proximal region of the plunger rod 21. In such an embodiment, the purely longitudinal movement of the plunger rod 21 from the ready position shown in FIG2 to the finished position shown in FIG3 means that the protrusion 30 moves only longitudinally and is therefore always aligned with the display window 25 during the injection process.

[0081] In another embodiment, the plunger rod 21 can be rotatably moved during its longitudinal movement from the ready position to the finished position. In such an embodiment, the protrusion 30 can be rotatably disengaged from the plunger rod 21, such that the protrusion 30 remains aligned with the display window 25 throughout the injection process. Therefore, any rotational movement of the plunger rod 21 will not cause rotation of the protrusion 30, and thus the protrusion 30 will not be removed from the display window by rotational movement.

[0082] The protrusion 30 can be restricted to longitudinal movement by a guide mechanism 40, as shown in FIG3. The guide mechanism 40 may include a guide element 41. The guide element 41 may be located on the inner surface 42 of the housing 11. The guide element 41 may be configured to prevent rotational movement of the protrusion about the longitudinal axis of the plunger rod 21. In one embodiment, the guide element 41 may protrude inwardly from the inner surface 42 of the housing 11. The guide element 41 may extend longitudinally along the inner surface 42 of the housing 11. The guide element 41 may extend along the periphery of the display window 25 to prevent rotation of the protrusion 30 away from the display window 25. A guide element 41 may be located on either side of the display window 25 to prevent rotation in both directions about the longitudinal axis.

[0083] When the protrusion is fixedly attached to the plunger rod 21, the guide mechanism 40 can be used to prevent rotation of only the protrusion 30 or rotation of both the protrusion 30 and the plunger rod 21.

[0084] In embodiments where the plunger rod 21 and the protrusion 30 are formed separately and then fixed together, the protrusion 30 may further include a connecting element 44. The connecting element 44 is located on the end of the flange 35 opposite to the arm 34. The connecting element 44 may include, for example, but not limited to, a snap-fit ​​connection having two arms engaging around a proximal region of the plunger rod 21 or an annular ring located in a groove on the plunger rod 21. These types of connecting elements 44 allow rotation of the plunger rod 21 relative to the protrusion 30.

[0085] In one embodiment, the protrusion 30 may include an annular element (not shown) instead of a longitudinally extending arm 34. The annular element may extend up to 360 degrees about the longitudinal axis such that any rotation of the protrusion 30 relative to the plunger rod 21 does not remove the protrusion 30 from the display window 25.

[0086] The outward-facing arm 34 of the protrusion 30 and the indicating element 36 include different markings configured to help the user determine the progress of the injection process at any time. The outward-facing arm 34 of the protrusion 30 includes a first marking, and the indicating element 36 includes a second marking different from the first marking. The markings may be, for example, but not limited to, one or more colors, color gradients, patterns, images, or numerical scales.

[0087] The syringe device 20 can be mechanically actuated. The indicator 24 can be a mechanical indicator. For example, the syringe device 20 shown in Figures 2 and 3 includes a biasing element 46. In this embodiment, the biasing element is a coil spring 47. When the syringe device 20 is actuated and the plunger rod 21 moves freely distally, the biasing element 46 pushes the plunger rod 21 toward the distal end D of the housing 11. The spring 47 may abut the flange 35 of the protrusion 30 or the proximal end 23 of the plunger rod 21 to push the plunger rod 21 to its completed position. The longitudinal movement of the plunger rod 21 in the distal direction also causes longitudinal movement of the protrusion 30 in the distal direction, and causes the proximal end 32 of the arm 34 of the protrusion to move distally from the proximal end of the display window 25 toward the distal end 28a of the display window 25 to expose the indicator element 36. As the spring 47 extends further, the proximal end 32 of the protrusion 30 moves closer to the distal end 28a of the display window 25 and exposes more of the indicator element 36.

[0088] In one embodiment, the housing 11 of the syringe device 20 may further include a second indicator 50. The second indicator 50 includes a second display window 51 having a distal end 52 and a proximal end 53. The second display window is located at a distal region D' of the housing 11. That is, the second indicator is positioned near the distal end D of the housing 11. The second display window 51 may also include a cover 54. When the plunger 21 is in its ready-to-fire position and the drug container 18 is received in the housing 11, the drug container 18 is visible through the second display window 50.

[0089] As the plunger rod 21 moves longitudinally toward the completed position, the distal end 23 of the plunger rod 21 moves through the second display window 51. When the plunger rod 21 is in its completed position, the distal end 23 of the plunger rod 21 may be located at the distal end of the second display window 51.

[0090] The plunger 21, protrusion 30, and indicator element 36 may include markings. In one embodiment, the plunger 21 and protrusion 30 may include a first marking, and the indicator element 36 may include a second marking different from the first marking. In this arrangement, the markings indicate to the user how far the plunger 21 has traveled by means of the movement of the first marking through the first display window 25 and the second display window 52, ​​and by means of the increased area of ​​the indicator element 36 as the plunger 21 moves from its ready position to its completed position.

[0091] In an alternative embodiment, the plunger rod 21 and the indicating element 36 may include a first mark, and the protrusion 30 may include a second mark different from the first mark. Preferably, the second mark on the protrusion 30 resembles the appearance of the medication in the medication container 18. In this arrangement, the progress of the injection process will be readily apparent to the user, as the second mark indicates how far the plunger rod has traveled, while the first mark indicates how close the plunger rod 21 is to the end of the process.

[0092] Briefly referring to Figures 5 and 6, the syringe device 20 may further include an outer sleeve 55. The outer sleeve 55 is configured to extend around the housing 11. Furthermore, the outer sleeve 55 is configured to move longitudinally from a first position at the proximal end P of the housing 11 shown in Figure 5 to a second position at the distal end D of the housing 11 shown in Figure 6.

[0093] Referring to Figure 5, when the outer sleeve 55 is in its first position, the second display window 51 is visible and the medicine container 18 is inside the housing 11, while the first display window 25 is hidden behind the outer sleeve. Now, referring to Figure 6, when the outer sleeve 55 is in its second position, the second display window 51 is hidden and the first display window 25 is visible.

[0094] When the user grips the syringe device 20, the outer sleeve 55 can be moved by the user. The force required to move the outer sleeve 55 is less than the force required to retract the needle sleeve 19 into the housing 11, such that when the user pushes the distal end D of the device 20 into its body, the outer sleeve moves longitudinally to the distal end of the housing 11 before the needle sleeve 19 retracts. This ensures that the user grips the syringe device 20 close to the distal end D of the housing 11, thereby improving the stability of the device 20 during injection.

[0095] Referring now to Figures 7 and 8, an embodiment of the syringe device 110 of the present invention is shown. The syringe device 110 of the present invention is similar to the syringe device 10 described above, and therefore the features and components of the device 110 that are the same as those of the device 10 described above will retain the same terminology and corresponding reference numerals.

[0096] The syringe device 110 includes a housing 111 configured to receive a drug container 118, i.e., a cartridge. The drug container 118 can refer to a container for receiving a drug or a container at least partially filled with a drug. The housing 111 is elongated and includes a proximal end P and a distal end D. The drug container 118 is received in the distal region D' of the housing 111. That is, the drug container 118 is positioned closer to the distal end D of the housing 111 than to the proximal end P of the housing 111.

[0097] For the purposes described below, the distal region D' can be considered as part of the housing 111, which is closer to the distal end D of the housing 111 than to the proximal end P of the housing 111. The proximal region P' of the housing 111 can be considered as part of the housing 111, which is closer to the proximal end P of the housing 111 than to the distal end D of the housing 111.

[0098] In Figures 7 through 10, the housing 111 of the syringe device 110 is shown in a schematic cross-sectional view to more clearly illustrate the internal components of the syringe device 110. For clarity, some components of the syringe device 110 are not shown in Figures 7 through 10 (such as the cap 12 and the needle sleeve 19) for simplification.

[0099] The syringe device 110 further includes a plunger rod 121, which is longitudinally movable within the housing 111 between a ready-to-fire position (shown in FIG. 7) and a completed position (where the plunger rod 121 is almost at this position in FIG. 8). Preferably, the plunger rod 121, when in its ready-to-fire position (not fully), is primarily located in the proximal region P', and when in its completed position (not fully), it is primarily located in the distal region D'. Thus, the plunger rod 121 can move from the proximal region P' of the housing 111 to the distal region D' of the housing 111 during the injection process. In any case, when the plunger rod 121 is in its completed position, it is positioned closer to the distal end D of the housing 111 compared to when it is in its ready-to-fire position.

[0100] The syringe device 110 further includes a drug container 118. The plunger rod includes a distal end 122 and a proximal end 123. The drug container 118 is received within the housing 111 between the plunger rod 121 and the distal end D of the syringe device 110.

[0101] The plunger rod 121 includes a stopper 114 located at its distal end 122. The stopper 114 is configured to contact the sidewall(s) of the drug container 118 to form a seal, such that when the plunger rod 121 is moved longitudinally in the distal direction from the ready position toward the distal position, the drug is ejected from the drug container 118 and passes through the needle 117.

[0102] The syringe device 110 further includes an indicator 124. The indicator 124 is located in a proximal region P' of the housing 111. Preferably, the indicator 124 is located in a region proximal to P. That is, preferably, the indicator 124 is positioned close to (in cases where not located at the proximal end) the proximal end P of the housing 111. The indicator 124 is configured to provide the user with information related to the progress of the injection process, depending on the longitudinal position of the plunger rod 121 between the ready position and the completed position.

[0103] The indicator 124 of the syringe assembly 110 includes a spindle 126. The spindle 126 includes a shaft 127 and a dial 128. The dial 128 is configured to rotate depending on the longitudinal position of the plunger rod 121 to provide the user with information associated with the progress of the injection process. The dial 128 includes a display surface 129. The display surface 129 of the dial 128 provides information associated with the progress of the injection process. The dial 128 is fixedly attached to the shaft 127 such that rotational movement of the shaft 127 causes rotation of the dial 128.

[0104] As shown in Figures 7 and 8, the shaft 127 of the mandrel 126 includes a distal end 131 and a proximal end 132. The shaft 127 is fixedly attached to the dial 128 at its proximal end 132. In this embodiment, the dial 128 has a larger diameter than the shaft 127 of the mandrel 126. The larger diameter of the dial 128 allows for a larger display surface 129 for providing the user with information associated with the progress of the injection procedure. The dial 128 includes a distal surface 133 and an opposite proximal surface 134. The proximal surface 134 of the dial 128 faces the exterior of the device 110. In this embodiment, the proximal surface 134 is the display surface 129. That is, the proximal surface 134 provides information associated with the progress of the injection procedure.

[0105] The plunger rod 121 includes a first threaded arrangement 135, and the shaft 127 of the mandrel 126 includes a second threaded arrangement 136. The second threaded arrangement 136 on the shaft 127 is configured to engage with the first threaded arrangement 135 on the plunger rod 121. The engagement between the threaded arrangements 135 and 136 on the shaft 127 of the plunger rod 121 and the mandrel 126 is configured such that longitudinal movement of the plunger rod 121 from a ready position toward a finished position causes rotation of the shaft 127 and thus the dial 128 to provide the user with information related to the progress of the injection process, as will be described in more detail below.

[0106] The spindle 126 is restricted from moving in the longitudinal direction. That is, longitudinal movement of the spindle 126 is prevented. In some embodiments, the housing 111 prevents longitudinal movement of the spindle 126. There are many ways to configure the housing 111 to prevent longitudinal movement of the spindle 126.

[0107] For example, in one embodiment shown in Figures 7 and 8, the dial 128 contacts the proximal end P of the housing 111. That is, the dial 128 is located at the proximal end of the housing 111 such that the distal surface 133 of the dial 128 contacts the proximal end of the housing 111.

[0108] The housing 111 includes a longitudinal sidewall 138 extending at a proximal end P of the housing 111, the sidewall 138 including an end surface 139. In this embodiment, the end surface 139 is annular when viewed from the proximal end P of the housing 111. However, in some embodiments, the end wall 139 may include an end plate extending across the proximal end P of the housing 111.

[0109] Furthermore, the dial 128 is positioned such that its distal surface 133 contacts the proximal end surface 139 of the housing 111. Therefore, as the plunger rod 121 moves longitudinally from the ready position toward the finished position, the end surface 139 of the housing 111 prevents the spindle 126 from moving longitudinally toward the finished position by acting on the distal surface 133 of the dial 128. In an embodiment where the dial 128 is located at the proximal end of the housing 111, the proximal surface 134 of the dial 128 is the closest end of the device 110.

[0110] Other example configurations for preventing longitudinal movement of the spindle 126 include an inner surface 142 of the housing 111 comprising a groove (not shown) (143) in which a protrusion (not shown) (144) extending from the side 145 of the shaft 127 or dial 128 is located. Such a groove prevents longitudinal movement of the spindle 126 toward and away from the finished position. Alternatively, the protrusion 144 may extend from the inner surface 142 of the housing 111 into the groove 143 located in the shaft 127 of the spindle 126 (as shown in FIG. 10) or in the side 141 of the dial 128. In some embodiments, the protrusion may be formed by an end plate that forms an end surface 139 of the housing 111.

[0111] In an alternative embodiment shown in FIG9, the dial 128 may be located inside the housing 111 such that the proximal surface 134 of the dial 128 faces outward from the housing 111 to provide the user with information associated with the progress of the injection process. In such an embodiment, preferably, the dial 128 is located within the housing 111 such that the proximal surface 134 of the dial 128 does not extend beyond the plane of the proximal end P of the housing 111. That is, the proximal surface 134 of the dial 128 does not extend beyond the end surface 139 of the housing 111.

[0112] The housing 111 further includes a cover 146. The cover 146 extends on the proximal surface 134 of the dial 128. The cover 146 may also extend on the proximal end P of the housing 111. The cover 146 may include a peripheral protrusion 146a configured to reside in a recess 146b on the inner surface 142 of the housing 111. In some embodiments, the cover 146 may not extend beyond the plane of the proximal end P of the housing 111, i.e., the cover 146 does not extend beyond the end surface 139 of the housing 111. In other embodiments, the cover 146 may form the proximal end of the syringe device 110.

[0113] Cover 146 is configured to allow dial 128 to provide the user with visual feedback related to the progress of the injection procedure. Cover 146 may be transparent or at least semi-transparent to allow the user to see dial 128 underneath. In some embodiments, only a portion of the cover may be configured to allow the user to see dial 128.

[0114] The dial 128 shown in Figures 7 through 9 can be configured in various ways to provide the user with visual feedback associated with the progress of the injection process. The proximal surface 134 of the dial 128 can be curved, such that the proximal surface is dome-shaped, or, in an alternative embodiment, the proximal surface 134 of the dial 128 can be flat. Furthermore, the proximal surface 134 of the dial 128 can be uninterrupted. That is, the proximal surface 134 can be free of holes or indentations. In such an embodiment, the proximal surface 134 of the dial 128 may include markings configured to align with markings on the proximal end of the sidewall 138 of the housing 111.

[0115] For example, one of the proximal surface 134 and the sidewall 138 may include an arrow pointing to the periphery of the dial 128, and the other of the proximal surface 134 and the sidewall 138 may include a marker that provides information associated with the progress of the injection process by means of, but not limited to, numerical scales, color gradients, or words representing events that occur during the injection process.

[0116] Briefly referring to FIG11, another exemplary embodiment of the dial 128 is shown. Referring to the embodiment shown in the upper right of FIG11, the dial 128 may be at least partially transparent. That is, the entire dial 128 may be transparent or at least translucent, allowing the user to see through the dial 128. Alternatively, only a portion of the dial 128 may be transparent or translucent. The syringe device 110 may further include a display panel 147 located in a housing 111 distal to the dial 128. The display panel 147 may include markings on its proximal surface 148 (i.e., the surface facing the exterior of the syringe device 110 and toward the dial 128). In the illustrated example, one of the proximal surfaces 148 of the dial 128 and the display panel 147 includes an arrow 149, and the other of the dial 128 and the proximal surface 148 includes textual markings 151 indicating events occurring during injection. As the plunger rod 121 moves longitudinally toward its completed position, the dial 128 will rotate, and the event indicated by arrow 149 will change to provide the user with information related to the progress of the injection process.

[0117] It should be understood that the shaft 127 of the mandrel 126 can pass through a central hole in the display panel 147. Furthermore, it should be understood that the display panel 147 of the housing 111 may include a groove 143 or a protrusion 144 to interact with the shaft 127 of the mandrel 126 to prevent longitudinal movement of the mandrel 126 during injection. It should also be understood that in some embodiments, the display panel 147 may form the end surface 139 of the housing 111.

[0118] Briefly referring to the embodiment shown on the left side of FIG11, dial 128 may include a notch 152. The notch 152 extends from the proximal surface 134 through dial 128 to the distal surface 133 and allows the user to see the display panel 147 below dial 128. The notch 152 may have, for example, but not limited to, a fan-shaped shape. Dial 128 may also include a display window 153. The display window 153 is similar to the notch because it extends from the proximal surface 134 through dial 128 to the distal surface 133 to allow the user to see the display panel 147 below dial 128. The display window 153 may be, for example, but not limited to, a semi-circular or crescent shape. However, the notch 152 and the display window 153 may be located at different radial and angular positions in dial 128 and may be used to provide different information about the progress of the injection process. Briefly referring to the embodiment shown in the lower right part of FIG11, it can be seen that multiple notches 152 may be formed in dial 128.

[0119] Both the cutout 152 and the display window 153 may include a cover 154 configured to be placed within the cutout 152 or the display window 153 to prevent debris from entering the housing 111 of the syringe device 110. The cover 154 may be transparent or at least translucent so that a user can see the markings on the proximal surface 148 of the display panel 147 through the cover 154. The cover 154 may be formed from a transparent or translucent portion of the dial 128, rather than being inserted into the cutout 152 or the display window 153.

[0120] In the above embodiment, as the dial 128 rotates relative to the display panel 147, the incision 152 and / or window 153 moves on the proximal surface 148 of the display panel 147, such that as the rotational position of the incision 152 and / or display window 153 changes, the markings visible through the incision 152 and / or display window 153 on the proximal surface 148 of the display panel 147 also change. Therefore, the change in markings provides visual feedback on the progress of the injection process.

[0121] In the above embodiment, the dial 128 includes a cutout 152 and / or a display window 153 to allow a user to see markings located on the proximal surface 148 of the display panel 147. However, in an alternative embodiment, the cover 146 may include a transparent or at least translucent portion, and the markings may be located on the proximal surface 134 of the dial 128. Therefore, as the dial 128 rotates relative to the transparent portion of the cover 146, the markings on the proximal surface 134 of the dial 128 pass beneath the transparent portion of the cover 146 to provide the user with information associated with the progress of the injection procedure.

[0122] In some implementations, dial 128 may be configured to provide the user with tactile feedback associated with the progress of the injection process, rather than visual feedback. An example of such an implementation is shown in Figure 10. In Figure 10, the proximal surface 134 of dial 128 includes a surface feature 156 configured to provide the user with tactile feedback associated with the progress of the injection process. The surface feature 156 may be formed, for example, but not limited to, one or more protrusions, one or more indentations, or surface roughness.

[0123] In another embodiment of the syringe device 110, the dial 128 may be housed within a housing 111. The housing 111 may include a display window (158) in its side wall 138 through which the side 145 of the dial 128 can be viewed. The side 145 of the dial 128 may include markings configured to provide the user with visual feedback associated with the progress of the injection process.

[0124] Referring back to Figures 7 and 8, the plunger rod 121 is shown as threadedly engaged with the shaft 127 of the spindle 126. In this embodiment, a first thread arrangement 135 on the plunger rod 121 faces inward. That is, in this embodiment, the plunger rod 121 includes a hollow tubular housing 161. The tubular housing 161 includes a distal sidewall 162 and longitudinally extending sidewalls 163. In this embodiment, the housing 161 is cylindrical, and therefore the sidewalls 163 are annular when viewed from the proximal end P of the housing 111. The tubular rod 161 includes an open proximal end 164 and an inner cavity 165. The inner cavity 165 is defined by the inner surface 166 of the sidewall 163 and the inner surface 167 of the distal sidewall 162. The first thread arrangement 135 on the plunger rod 121 is formed on the inner surface 166 of the sidewall 163 of the plunger rod 121.

[0125] The plunger rod 121 is restricted to longitudinal movement. That is, the plunger rod 121 can move in the longitudinal direction, but is prevented from rotating about the longitudinal axis. The plunger rod 121 includes a protrusion 168 configured in a groove on the inner surface 142 of the housing 111. The protrusion 168 extends radially outward from the outer surface 169 of the plunger rod 121. The groove in the inner surface 142 of the housing 111 extends longitudinally for a distance at least equal to the distance the plunger rod 121 must travel between the ready position and the finished position. The sidewalls of the groove abut the protrusion 168 of the plunger rod 121 to prevent the plunger rod 121 from rotating relative to the housing 111.

[0126] A cavity 165 formed in the plunger rod 121 is configured to at least partially receive the shaft 127 of the mandrel 126. Preferably, when the plunger rod 121 is in its ready-to-fire position, the distal end 127 of the shaft 127 abuts the inner surface 167 of the distal wall 162, i.e., the proximal surface of the plunger rod 121. The shaft 127 of the mandrel 126 includes a second threaded arrangement 136 on its outer surface 171. The second threaded arrangement 136 on the outer surface 171 of the shaft 127 of the mandrel 126 is configured to thread-engage a first threaded arrangement 135 on the inner surface 166 of the plunger rod 121.

[0127] In the embodiments shown in Figures 7 and 8, the shaft 127 of the mandrel 126 is located inside the plunger rod 121. However, it should be understood that in alternative embodiments, the shaft 127 of the mandrel 126 may be located outside the plunger rod 121. In such an embodiment, a first threaded arrangement 135 may be located on the outer surface 169 of the plunger rod 121, and a second threaded arrangement 136 will be located on the inner surface of the shaft 127.

[0128] In this embodiment, the first thread arrangement 135 on the plunger rod 121 includes a continuous thread arrangement. That is, the continuous thread arrangement includes a continuous thread 172. The continuous thread arrangement extends from the distal end 173 of the inner surface 166 of the plunger rod 121 to the proximal end 174 of the inner surface 166 of the plunger rod 121. In other words, the continuous first thread arrangement 135 extends along the length of the inner surface 166 of the plunger rod 121. Similarly, the second thread arrangement 136 on the shaft 127 of the spindle 126 includes a continuous thread arrangement. The continuous thread arrangement extends from the distal end 131 of the shaft 127 toward the proximal end 132 of the shaft 127. In this embodiment, the second thread arrangement 136 extends only along the shaft 127 by a distance equal to the length of the inner surface 166 of the plunger rod 121. Therefore, the first thread arrangement 135 and the second thread arrangement 136 contact each other throughout the longitudinal movement of the plunger rod 121 between the ready position and the finished position.

[0129] The inner surface 166 of the sidewall 163 of the plunger rod 121 determines the maximum longitudinal travel distance between the ready position and the finished position of the plunger rod 121. This is necessary because once the plunger rod 121 and the mandrel 126 are no longer in threaded engagement, the dial 128 cannot provide accurate information about the progress of the injection process. The continuous threads on the shaft 127 of the plunger rod 121 and / or the mandrel 126 are configured to ensure that the mandrel 126 is rotated constantly as the plunger rod 121 is axially moved, in order to provide continuous feedback on the progress of the injection process.

[0130] In some embodiments, the longitudinal length of the continuous thread on one of the shafts 127 of the plunger rod 121 and the mandrel 126 is equal to the longitudinal distance between the ready-to-launch position and the finished position of the plunger rod 121. This allows the dial 128 of the mandrel 126 to provide feedback on the progress of the injection process, depending on the position of the plunger rod 121, at any stage between the ready-to-launch and finished positions.

[0131] In other embodiments, the longitudinal length of the continuous thread on one of the shafts 127 of the plunger rod 121 and the mandrel 126 is greater than the longitudinal distance between the ready position and the finished position of the plunger rod 121. This allows the dial 128 of the mandrel 126 to provide feedback on the progress of the injection process, depending on the position of the plunger rod 121, before the plunger rod 121 moves to its ready position and / or after the plunger rod 121 has moved to its finished position.

[0132] For example, the plunger rod 121 may have a loading position adjacent to the ready-to-fire position, in which the plunger rod 121 is held until the drug container 118 is loaded into the housing 121. The plunger rod 121 can then be moved distally from the loading position to the ready-to-fire position, in which the stopper 114 contacts the proximal end of the drug container 118.

[0133] As can be seen in Figures 7 and 8, the syringe assembly 110 further includes a biasing element 175. In the illustrated embodiment, the biasing element 175 is a helical spring 176. However, it will be apparent to those skilled in the art that any other type of biasing member 175 may be used. The helical spring 176 is positioned such that its longitudinal axis coincides with the longitudinal axis of the shaft 127 of the spindle 126 and the longitudinal axis of the plunger rod 121. Therefore, the helical spring 176 extends about the shaft 127 of the spindle 126. This helps prevent the spring 176 from bending out of alignment with the longitudinal axis when compressed.

[0134] The helical spring 176 includes a distal end 177 and a proximal end 178. The distal end 177 of the helical spring 176 contacts the proximal end 123 of the plunger rod 121. The proximal end 178 of the helical spring 176 contacts the housing 111 in the proximal region P'. In some embodiments, the proximal end 178 of the helical spring 176 may abut the display panel 147, the inner surface 142 of the housing 111, or a protrusion extending from the inner surface 142 of the housing 111. When the plunger rod 121 is in its ready-to-fire position, the biasing member 175 is under a higher compression than when the plunger rod 121 is in its finished position.

[0135] When the syringe assembly 111 is actuated, the locking element preventing longitudinal movement of the plunger rod 121 is released, and the biasing member 175 extends from its compressed state. The proximal end 178 of the helical spring 176 is attached to the fixed housing 111, and thus the extension of the spring 176 pushes the distal end 177 of the spring 176 and therefore the plunger rod 121 distally in the longitudinal direction. Due to the position of the protrusion 168 of the plunger rod 121 in the groove in the inner surface 142 of the housing 111, the movement of the plunger rod 121 in the distal direction is restricted to longitudinal movement.

[0136] The longitudinal movement of the plunger rod 121 causes the first threaded arrangement 135 to move distally. Because the spindle 126 is prevented from moving longitudinally, the distal longitudinal movement of the first threaded arrangement 135 causes the second threaded arrangement 136 to slide against the first threaded arrangement 136. This causes the shaft 127 of the spindle 126 and consequently the dial 128 to rotate. The rotation of the dial 128 provides the user with feedback on the progress of the injection process.

[0137] Referring briefly to Figure 12, another embodiment of the threaded arrangement can be seen. In an alternative embodiment, the threaded arrangement includes a discontinuous thread 181 on one of the piston rod 121 and the shaft 127 of the spindle 126. In Figure 12, the first threaded arrangement 135 on the inner surface 166 of the piston rod 121 is a continuous thread 172. However, the continuous thread 172 extends only a small longitudinal distance at the proximal end of the piston rod 121. The second threaded arrangement 136 on the shaft 127 of the spindle 126 includes the discontinuous thread 181. The discontinuous thread 181 includes a proximal portion 182 and a distal portion 183.

[0138] Therefore, as the plunger rod 121 moves longitudinally, the continuous first thread arrangement 135 on the plunger rod 121 engages the proximal portion 182 of the discontinuous second thread arrangement 136 to rotate the dial 128 until these thread arrangements no longer contact each other. Once the plunger rod 121 and the shaft 127 are no longer threadedly engaged, further longitudinal movement of the plunger rod 121 does not cause rotation of the dial 128 until the continuous first thread arrangement 135 on the plunger rod 121 engages the distal portion 183 of the discontinuous second thread arrangement 136 to rotate the dial 128.

[0139] In such an implementation, the discontinuous thread 181 is configured to provide event-specific feedback regarding the progress of the injection process. This is illustrated by the discontinuous rotational movement of the dial 128 as the plunger rod 121 moves longitudinally from the ready position to the completed position. For example, rotation of the proximal portion 182 of the discontinuous thread 181 can cause the dial 128 to rotate from indicating that the drug container 118 is loaded to indicating that the plunger rod 121 is in its ready position, and rotation of the distal portion 183 of the discontinuous thread 181 can cause the dial 128 to rotate from indicating that the plunger rod 121 is in its ready position to indicating that the plunger rod 121 is in its completed position.

[0140] In an embodiment where the first thread arrangement 135 includes a discontinuous thread 181 and the second thread arrangement 136 includes a continuous thread, the continuous thread may be located on the distal end 131 of the shaft 127.

[0141] Furthermore, it should be understood that in some embodiments, a continuous thread on one of the plunger rod 121 and shaft 127 can be replaced by a protrusion extending into a continuous or discontinuous thread on the other of the plunger rod 121 and shaft 127. In these embodiments, the thread pitch can vary along the length of the thread arrangement. An increase in pitch can result in lower friction with the thread because the thread angle is more closely aligned with the longitudinal direction of movement. Therefore, the thread pitch can be increased toward the distal end of shaft 127 to reduce the force required for longitudinal movement from biasing element 173. This helps to overcome the reduced force exerted by spring 174 on plunger rod 121 during extension. Alternatively, the pitch can be changed (i.e., reduced) at event-specific stages to allow dial 128 to rotate more quickly.

[0142] Referring briefly to Figure 13, it can be seen that in an alternative embodiment, the spindle 126 may be hollow and open at the end. In such an embodiment, the biasing member 173 may be accommodated in the hollow portion of the spindle 126. Therefore, the distal end 175 of the spring 174 may contact the inner surface 166 of the distal sidewall 162 of the plunger rod 121.

[0143] In some alternative embodiments, the feedback provided by dial 128 may include other types of feedback as discussed above. For example, the feedback provided by dial 128 may be, but is not limited to, animation, visual, or motion. The feedback may be designed to make the user or recipient of the medication comfortable. In some embodiments, the dial may include a display for showing the feedback. Alternatively, an image may be set on the surface of the dial.

[0144] Feedback can begin when the device is actuated. In some embodiments, feedback can begin before the plunger rod moves from the ready-to-fire position, such as, but not limited to, when the cap or retracting needle guard is removed. In some embodiments, feedback can begin at least 2 seconds before the plunger rod moves. More preferably, feedback can begin at least 5 seconds before the plunger rod moves.

[0145] Feedback can be terminated when the injection is complete. That is, feedback can begin when the plunger moves from the ready position and end when the plunger is in the completed position. In some embodiments, feedback can end after the plunger has reached the completed position. Feedback can continue for a given period of time after injection is complete. For example, feedback can continue for at least 2 seconds after injection is complete. More preferably, feedback can continue for at least 5 seconds after injection is complete.

[0146] Those skilled in the art will understand that the syringe device 20 shown in Figures 2 to 6 can incorporate the features described with reference to the syringe device 111 shown in Figures 7 to 13, even if these features are not explicitly described in the same embodiment. Furthermore, those skilled in the art will understand that the syringe device 111 shown in Figures 7 to 13 can incorporate the features described with reference to the syringe device 20 shown in Figures 2 to 6, even if these features are not explicitly described in the same embodiment. The embodiments are described separately only to provide clarity regarding each mechanism, and the features shown in Figures 2 to 6 and the features shown in Figures 7 to 13 can be combined into the same syringe device.

[0147] The terms "drug" or "pharmaceutical" are used herein to describe one or more pharmaceutically active compounds. As described below, a drug or pharmaceutical agent may comprise at least one small molecule or macromolecule or combination thereof in various types of formulations for the treatment of one or more diseases. Exemplary pharmaceutically active compounds may include small molecules; 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 of these drugs are also contemplated.

[0148] The term "drug delivery device" should encompass any type of device or system configured to dispense a drug into a human or animal body. Without limitation, a drug delivery device can be a syringe device (e.g., a syringe, pen syringe, autoinjector, bulk device, pump, infusion system, or other device configured for intraocular, subcutaneous, intramuscular, or intravascular delivery), a skin patch (e.g., osmotic, chemical, microneedle), an inhaler (e.g., nasal or lung), an implantable device (e.g., a coated stent, capsule), or a feeding system for the gastrointestinal tract. The drugs described herein may be particularly useful using syringe devices, including needles (e.g., small-gauge needles).

[0149] A drug or pharmaceutical preparation may be contained in a primary package or "drug container" suitable for use with a drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other vessel configured to provide a suitable chamber for storing (e.g., short-term or long-term storage) one or more pharmaceutically active compounds. For example, in some cases, the chamber may be designed to store the drug for at least one day (e.g., from 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 be carried out 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 of a pharmaceutical preparation (e.g., drug and diluent, or two different types of drugs), one component in each chamber. In such cases, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components of the drug or pharmaceutical preparation before and / or during administration to a human or animal body. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., by means of a conduit between the two chambers) and allow the user to mix the two components before dispensing if needed. Alternatively or additionally, the two chambers can be configured to allow mixing during dispensing of the components into a human or animal body.

[0150] The drug delivery devices and drugs described herein can be used to treat and / or prevent many different types of disorders. Exemplary disorders include, for example, diabetes or diabetes-related complications (such as diabetic retinopathy) and thromboembolic disorders (such as deep vein or pulmonary thromboembolism). Other exemplary disorders include acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis.

[0151] Exemplary medicines for the treatment and / or prevention of diabetes or diabetes-related complications 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 mixtures thereof. As used herein, the term “derivative” means any substance that is structurally sufficiently similar to the original substance to have substantially similar functions or activities (e.g., therapeutic efficacy).

[0152] Exemplary insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (glargine insulin); Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala and wherein the 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.

[0153] Exemplary insulin derivatives include, for example, B29-N-myristoyl-des(B30) human 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-Thr B29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin; 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. Exemplary GLP-1, GLP-1 analogs, and GLP-1 receptor agonists are, for example: lixumia / AVE0010 / ZP10 / Lyxumia, exenatide / Exendin-4 / Byetta / Bydureon / ITCA 650 / AC-2993 (a 39-amino acid peptide derived from Gila) (produced by the salivary glands of monster), liraglutide / Victoza, semaglutide, taspoglutide, Syncria / 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.

[0154] An example oligonucleotide is, for instance, mipomersen / Kynamro, a cholesterol-reducing antisense agent used to treat familial hypercholesterolemia.

[0155] Exemplary DPP4 inhibitors include vidalliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0156] Exemplary 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.

[0157] Exemplary 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 / Synvisc, which is a sodium hyaluronate.

[0158] 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, which retain the ability to bind antigens. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., murine) antibodies, or single-chain antibodies. In some embodiments, antibodies have effector function and can fix complement. In some embodiments, antibodies have reduced or no ability to bind to Fc receptors. For example, antibodies can be isotypes or subtypes, antibody fragments, or mutants that do not support binding to Fc receptors, for example, they may have a mutagenic or missing Fc receptor-binding region.

[0159] 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, excluding full-length antibody polypeptides but still including 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, and multispecific antibodies (e.g., double-chain, triple-chain, and quadruple-chain antibodies)), microantibodies, chelated recombinant antibodies, tri- or bispecific 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.

[0160] 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 does not typically participate directly 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.

[0161] Exemplary antibodies are anti-PCSK-9 mAb (e.g., Alirocumab), anti-IL-6 mAb (e.g., Sarilumab), and anti-IL-4 mAb (e.g., Dupilumab).

[0162] The compounds described herein can be used in pharmaceutical formulations comprising (a) one or more compounds or pharmaceutically acceptable salts thereof, and (b) pharmaceutically acceptable carriers. The compounds can also be used in pharmaceutical formulations comprising one or more other active pharmaceutical ingredients, or in pharmaceutical formulations in which the compound of the present invention or a pharmaceutically acceptable salt thereof is the sole active ingredient. Therefore, pharmaceutical formulations of this disclosure cover any formulation prepared by mixing the compounds described herein with a pharmaceutically acceptable carrier.

[0163] Pharmaceutically acceptable salts of any of the drugs described herein are also contemplated for use in drug delivery devices. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts. Acid addition salts are, for example, HCl salts or HBr salts. Basic salts are, for example, salts having cations selected from: alkali metals or alkaline earth metals, such as Na+, or K+, or Ca2+, or ammonium ions N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently represent: hydrogen, optionally substituted C1-C6-alkyl groups, optionally substituted C2-C6-alkenyl groups, optionally substituted C6-C10-aryl groups, or optionally substituted C6-C10-heteroaryl groups. Further examples of pharmaceutically acceptable salts are known to those skilled in the art.

[0164] Pharmaceutically acceptable solvates are, for example, hydrates or alkanolates, such as methanolates or ethanolates.

[0165] Those skilled in the art will understand that various modifications (additions and / or removals) can be made to various components of the substances, preparations, apparatus, 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.

[0166] This instruction manual includes the following clauses:

[0167] 1. A syringe device comprising:

[0168] An elongated shell having a proximal end and a distal end and configured to receive a pharmaceutical container;

[0169] A plunger rod, which is longitudinally movable within the housing between a ready position and a completed position, is configured to engage with a pharmaceutical container when received within the housing;

[0170] The housing includes an indicator located in a proximal region of the housing; the indicator is configured to provide the user with information related to the progress of the injection process, depending on the longitudinal position of the plunger rod.

[0171] 2. The syringe device according to Clause 1, wherein the indicator includes a spindle, the spindle including a shaft and a dial, wherein the dial is configured to rotate to provide the user with information related to the progress of the injection process, depending on the longitudinal position of the plunger rod.

[0172] 3. The syringe device according to Clause 2, wherein the mandrel is restricted to not moving in the longitudinal direction and is rotatable relative to the plunger rod.

[0173] 4. The syringe device according to Clause 2 or Clause 3, wherein the housing prevents the mandrel from moving in the longitudinal direction.

[0174] 5. The syringe device according to any one of Clauses 2 to 4, wherein the dial is located at the proximal end of the housing such that the distal surface of the dial contacts the proximal end of the housing, and the proximal surface of the dial faces the outside of the device to provide the user with information associated with the progress of the injection process during use.

[0175] 6. The syringe device according to any one of Clauses 2 to 4, wherein the dial is located inside the housing at the proximal end of the housing such that the proximal surface of the dial faces outward from the housing to provide the user with information associated with the progress of the injection process.

[0176] 7. The syringe device according to any one of Clauses 2 to 6, wherein the proximal surface of the dial includes a surface configuration configured to provide the user with tactile feedback associated with the progress of the injection process.

[0177] 8. The syringe device according to Clause 6, wherein the housing includes a cover extending from the proximal end of the housing and on the proximal surface of the dial, the cover being configured such that the dial can provide the user with visual feedback associated with the progress of the injection process.

[0178] 9. The syringe device according to any one of Clauses 2 to 4, wherein the dial is housed within the proximal end of the housing, and the housing further includes a display window in its side through which the side of the dial is visible, the side of the dial including markings configured to provide the user with visual feedback associated with the progress of the injection process.

[0179] 10. The syringe device according to any one of Clauses 2 to 9, wherein the shaft of the mandrel includes a threaded arrangement configured to engage with a threaded arrangement on the plunger rod, such that longitudinal movement of the plunger rod from the ready position toward the finished position is configured to cause rotation of the dial of the mandrel.

[0180] 11. The syringe device according to Clause 10, wherein the threaded arrangement includes a continuous thread on at least one of the shafts of the plunger rod and the mandrel, the continuous thread being configured to provide continuous feedback on the progress of the injection process.

[0181] 12. The syringe device according to Clause 10 or Clause 11, wherein the threaded arrangement includes a discontinuous thread on one of the shafts of the plunger rod and the mandrel, the discontinuous thread being configured to provide event-specific feedback regarding the progress of the injection process.

[0182] 13. The syringe device according to Clause 11 or Clause 12, wherein the plunger rod is hollow and includes an open proximal end of the shaft configured to receive the mandrel, the plunger rod including threads on its inner surface, and the shaft including threads on its outer surface.

[0183] 14. The syringe device according to any one of the preceding clauses further includes a drug container received within the housing between the plunger rod and the distal end of the syringe device.

[0184] 15. A method of using a syringe device according to Clause 1, the method comprising:

[0185] Actuating the syringe device causes the plunger rod to move longitudinally within the housing from a ready-to-fire position to a completed position; and

[0186] An indicator is used to provide information associated with the longitudinal position of the plunger rod.

Claims

1. A syringe device (20) comprising: An elongated shell (11) having a proximal end (P) and a distal end (D) and configured to receive a pharmaceutical container (18); A plunger rod (21) is longitudinally movable within the housing between a ready position and a completed position, and the plunger rod is configured to engage with a pharmaceutical container when received in the housing; The housing includes an indicator (24) located in a proximal region (P') of the housing; the indicator includes: Display window (25), the display window being located in the proximal region (P') of the side wall of the housing, A proximal protrusion (30) extending from the plunger rod (21), wherein the protrusion is coupled to the plunger rod, and the protrusion is visible through the display window in at least the ready-to-fire position. The indicator element (36), wherein the protrusion (30) is located between the display window (25) and the indicator element in at least the ready position to obstruct the user's view of the indicator element. The protrusion is configured to move between a first indication position and a second indication position, wherein the movement of the protrusion toward the second indication position makes a larger portion of the indication element (36) visible through the display window (25), thereby providing the user with information related to the progress of the injection process depending on the longitudinal position of the plunger rod.

2. The syringe device (20) according to claim 1, wherein when the plunger rod (21) is in its completed position, the plunger rod (21) is positioned closer to the distal end (D) of the housing (11) than when the plunger rod (21) is in its ready-to-fire position.

3. The syringe device (20) according to claim 1, wherein the plunger rod (21) is primarily located in the proximal region (P') when in its ready-to-fire position, and the plunger rod (21) is primarily located in the distal region (D') when in its completed position.

4. The syringe device (20) according to claim 1, wherein the protrusion (30) is axially coupled to the plunger rod (21) and configured to move between a first indicated position and a second indicated position when the plunger rod moves from the ready position to the completed position.

5. The syringe device (20) according to claim 4, wherein when the protrusion (30) is in the first indicated position, the proximal end (32) of the protrusion (30) is located at the proximal end (28b) of the display window (25).

6. The syringe device (20) according to claim 5, wherein when the protrusion (30) is in the first indicated position, only the protrusion is visible through the display window (25).

7. The syringe device (20) according to any one of claims 4 to 6, wherein when the protrusion (30) is in the second indicated position, the proximal end (32) of the protrusion is located at the distal end (28a) of the display window (25).

8. The syringe device (20) according to claim 7, wherein when the protrusion (30) is in the second indicated position, only the indicated element (36) is visible in the display window (25).

9. The syringe device (20) according to any one of claims 1 to 6, wherein the longitudinal length of the display window (25) is substantially equal to the longitudinal distance between the ready position and the completed position of the plunger rod (21).

10. The syringe device (20) according to any one of claims 1 to 6, wherein the protrusion (30) extends in a proximal direction such that a majority of the protrusion (30) is positioned further away from the distal end (D) of the housing (11) than from the proximal end of the plunger rod (21).

11. The syringe device (20) according to any one of claims 1 to 6, wherein the protrusion (30) is rotatably disengaged from the plunger rod (21) such that the protrusion remains aligned with the display window (25) throughout the injection process.

12. The syringe device (20) according to claim 11, wherein the inner surface (42) of the housing (11) includes a guide mechanism (40) configured to restrict rotational movement of the protrusion (30) about the longitudinal axis of the plunger rod (21).

13. The syringe device (20) according to claim 12, wherein the guiding mechanism (40) includes a guiding element (41) extending from the inner surface (42) of the housing (11) and configured to prevent rotational movement of the protrusion about the longitudinal axis of the plunger rod (21).

14. The syringe device (20) according to claim 13, wherein the guide element (41) extends longitudinally along the periphery of the display window (25) to prevent the protrusion (30) from rotating away from the display window (25).

15. The syringe device (20) according to any one of claims 1 to 6, wherein the housing (11) further includes a second indicator (50) comprising a second display window (51) in a distal region (D') of the housing, wherein the drug container (18) is visible through the second display window when the plunger rod (21) is in its ready-to-fire position and when the drug container is received in the housing, and wherein the distal end of the plunger rod is located at the distal end (28a) of the second display window (51) when the plunger rod is longitudinally moved into the completed position.

16. The syringe device (20) according to claim 15, wherein the plunger rod (21) and the indicating element (36) include the same markings, and the protrusion (30) includes markings different from those of the plunger rod and the indicating element.

17. The syringe device (20) according to claim 15, wherein the plunger rod (21) and the protrusion (30) include the same markings, and the indicating element (36) includes markings different from those of the plunger rod (21) and the protrusion (30).

18. The syringe device (20) according to any one of claims 1 to 6, further comprising an outer sleeve (55) configured to extend around the housing (11), the outer sleeve being longitudinally movable from a first position at the proximal end (P) of the housing to a second position at the distal end (D) of the housing, in the first position the outer sleeve covering the indicator (24), and in the second position the outer sleeve exposing the indicator.

19. The syringe device (20) according to any one of claims 1 to 6, further comprising a medicine container (18) received in the housing (11) between the plunger rod (21) and the distal end (D) of the syringe device.

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