injection device

Abstract

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

Description

[Technical Field]

[0001] The present invention relates to an injection device for medication. [Background technology]

[0002] Injection devices, such as autoinjectors, typically have a sealed medication container and a needle for injecting the medication into a patient. In one type of device, the medication container can include a medication cartridge, with the needle initially separate from the cartridge. In an initial operation, the cartridge and needle move together, causing the needle to pierce the cartridge. In another type of device, the medication container can include a syringe containing the medication, with the needle secured to the syringe. In either case, a plunger or piston can then move within the cartridge or syringe to administer the medication to the patient through the injection needle. Summary of the Invention [Problem to be solved by the invention]

[0003] It is an object of the present invention to provide an advantageous injection device comprising: an elongated housing having a proximal end and a distal end and configured to receive a medication container; and a plunger rod longitudinally movable within the housing between a priming position and a completed position and configured to be engageable with the medication container when received in the housing, wherein the housing includes an indicator disposed at the proximal end of the housing, the indicator including: a display window disposed in a proximal region of a side wall of the housing; and a proximally extending protrusion extending from and coupled to the plunger rod, the protrusion being visible through the display window at least in the priming position, the protrusion being configured to move between a first indicating position and a second indicating position to provide a user with information related to the progress of the injection process depending on the longitudinal position of the plunger rod. [Means for solving the problem]

[0004] Preferably, the distal end of the housing is relatively close to the injection site and the proximal end is relatively far from the injection site.

[0005] The indicator further includes an indication element, the protrusion being positioned between the display window and the indication element so as to obstruct a user's view of the indication element at least in the priming position.

[0006] The protrusion is axially coupled to the plunger rod and is configured to move between a first indicating position and a second indicating position when the plunger rod is moved from the priming position to the completed position, and movement of the protrusion toward the second indicating position causes a larger portion of the indication element to be visible through the display window.

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

[0008] In one embodiment, when the protrusion is in the first indicating position, only the protrusion is visible through the display window.

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

[0010] In one embodiment, when the protrusion is in the second indicating position, only the indication element is visible within the display window.

[0011] Preferably, the protrusion is non-rotatably decoupled from the plunger rod so that it remains aligned with the display window during the injection process.

[0012] The interior surface of the housing may include a guide mechanism configured to limit 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 in a distal region of the housing, the second indicator including a second display window, wherein when the plunger rod is in its priming position and the drug container is received in the housing, the drug container is visible through the second display window, and when the plunger rod is moved longitudinally to the completed position, the distal end of the plunger rod is positioned at the distal end of the second display window.

[0014] In one embodiment, the plunger rod and the indication element may include the same indicia, and the protrusion includes indicia that are different from the plunger rod and the indication element.

[0015] In other embodiments, the plunger rod and the protrusion may include the same indicia, and the indication element may include indicia that are different from the plunger rod and the protrusion.

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

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

[0018] The indicator may include a spindle including an axis and a dial configured to rotate to provide a user with information related to the progress of the injection process depending on the longitudinal position of the plunger rod.

[0019] The spindle is restricted in longitudinal movement and is rotatable relative to the plunger rod.

[0020] The spindle is prevented from longitudinal movement by the housing.

[0021] The dial can be positioned at the proximal end of the housing such that, in use, the distal surface of the dial contacts the proximal end of the housing and the proximal surface of the dial faces outward from the device to provide the user with information relating to the progress of the injection process.

[0022] The dial can be 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 related to the progress of the injection process.

[0023] The proximal face of the dial may include a surface feature configured to provide tactile feedback to the user regarding the progress of the injection process.

[0024] The housing can include a cover extending from the proximal end of the housing to cover the proximal face of the dial, the cover configured such that the dial provides visual feedback to the user related to the progress of the injection process.

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

[0026] The shaft of the spindle can include a threaded mechanism configured to engage the threaded mechanism of the plunger rod such that longitudinal movement of the plunger rod from the priming position toward the finished position is configured to rotate the dial of the spindle.

[0027] The screw mechanism can include a continuous thread on at least one of the plunger rod and the axis of the spindle, the continuous thread configured to provide continuous feedback on the progress of the injection process.

[0028] The screw mechanism can include discontinuous threads on one of the plunger rod and the spindle axis, the discontinuous threads configured to provide event-specific feedback about the progress of the injection process.

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

[0030] Another object of the present invention is to provide a method of using an injection device, the method comprising: actuating the injection device such that the plunger rod is moved longitudinally within the housing from a priming position to a completion position; and providing information related to the longitudinal position of the plunger rod using an indicator.

[0031] These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter.

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

[0033] [Figure 1A] 1 is a schematic side view of an injection device and removable cap embodying the present invention. [Figure 1B] FIG. 1B is a schematic side view of the injection device of FIG. 1A with the cap removed from the housing. [Figure 2] 1 is a perspective view of an injection device according to the present invention in a priming position; FIG. [Figure 3] FIG. 3 is a schematic perspective view of the injection device of FIG. 2 in a completed position. [Figure 4] FIG. 3 is a schematic side view of the injection device of FIG. 2 as it is held during use. [Figure 5] FIG. 3 is a schematic side view of the injection device of FIG. 2, further including an outer sleeve that is retained at the start of the injection process. [Figure 6] FIG. 6 is a schematic side view of the injection device of FIG. 5 being held during the injection process. [Figure 7] FIG. 1 is a schematic cross-sectional view of an injection device according to the invention in a priming position; [Figure 8] FIG. 8 is a schematic cross-sectional view of the injection device of FIG. 7, with the plunger rod being moved towards a final position. [Figure 9] 8 is a schematic cross-sectional view of an alternative arrangement of the dial at the proximal end of the injection device of FIG. 7. FIG. [Figure 10] 8 is a schematic cross-sectional view of an alternative arrangement of the dial at the proximal end of the injection device of FIG. 7. FIG. [Figure 11] 8 shows a collection of embodiments of markings on the dial arrangement of the injection device of FIG. 7. [Figure 12] 8 shows a schematic cross-sectional view of an alternative thread engagement of the injection device of FIG. 7. [Figure 13] 8A and 8B show schematic cross-sectional views of alternative arrangements of the plunger rod and spindle of the injection device of FIG. 7. DETAILED DESCRIPTION OF THE INVENTION

[0034] Drug delivery devices, as described herein, can be configured to inject medication into a patient. For example, delivery can be subcutaneous, intramuscular, or intravenous. Such devices can be operated by the patient or a caregiver, such as a nurse or physician, and can include various types of safety syringes, pen injectors, or autoinjectors. Devices can include cartridge-based systems in which a sealed ampoule must be pierced before use. The volume of medication delivered using these various devices can range from about 0.5 ml to about 3 ml. Another device can include a large volume device ("LVD") or patch pump configured to adhere to a patient's skin for a period of time (e.g., about 5, 15, 30, 60, or 120 minutes) to deliver a "large" amount of medication (typically about 2 ml to about 50 ml). Yet another device can include a pre-filled syringe within the device's housing. The syringe can be fixed within the housing or movable within the housing, for example, from a retracted position to an operationally extended position.

[0035] The presently described devices can also be customized to operate within required specifications when paired with a particular drug. For example, the device can be customized to inject the drug within a certain period of time (e.g., about 3 to about 20 seconds for an autoinjector, or about 10 to about 60 minutes for an LVD). Other specifications may include low or minimal levels of discomfort, or certain requirements related to human factors, shelf life, expiration date, biocompatibility, and environmental considerations. Such variations may occur due to a variety of factors, such as, for example, drugs with viscosities ranging from about 3 cP to about 50 cP. As a result, drug delivery devices often include hollow needles ranging in size from about 25 to about 31 gauge. Common sizes are 17 and 29 gauge.

[0036] The delivery devices described herein may also include one or more automated features. For example, one or more of combining the needle with the cartridge, inserting the needle, injecting the medication, and retracting the needle may be automated. Energy for one or more automated steps may be provided by one or more energy sources. The energy source 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 incorporated 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.

[0037] The one or more automatic features of the autoinjector can each be activated via an activation mechanism. Such an activation mechanism can include one or more of an actuator, such as a button, a lever, a needle sleeve, or other activation component. Activation of the automatic feature can be a one-step or multi-step process. That is, a user may be required to activate one or more activation components to initiate the automatic feature. For example, in a one-step process, a user may depress the needle sleeve against their body to administer an injection of medication. Other devices may require multi-step activation of the automatic feature. For example, a user may be required to depress a button and retract a needle shield to administer an injection.

[0038] Additionally, activation of one automatic feature can activate one or more subsequent automatic features, forming an activation sequence. For example, activation of a first automatic feature can activate at least two of: combining the needle with the cartridge, inserting the needle, injecting the medication, and retracting the needle. Some devices may require a specific sequence of steps to activate one or more automatic features. Other devices may operate using a series of independent steps.

[0039] Some delivery devices can include one or more features of a safety syringe, a pen injector, or an autoinjector. For example, a delivery device can also include a mechanical energy source (typically found in an autoinjector) configured to automatically inject medication and a dose setting mechanism (typically found in a pen injector).

[0040] According to some embodiments of the present disclosure, an exemplary drug delivery device 10 is shown in Figures 1A and 1B. Device 10 is configured to inject a medication into a patient's body, as described above. Device 10 includes a housing 11, which typically includes a cartridge or pre-filled syringe defining a reservoir containing the medication to be injected, as well as components necessary to facilitate one or more steps of the delivery process.

[0041] Device 10 may also include a cap 12, which may be removably attached to housing 11. Typically, a user must remove cap 12 from housing 11 before device 10 can be operated.

[0042] As shown, the housing 11 is substantially cylindrical and has a substantially constant diameter along a longitudinal axis AA. The housing 11 has a distal region D and a proximal region P. The term "distal" refers to a location relatively closer to the injection site, and the term "proximal" refers to a location relatively farther from the injection site.

[0043] The device 10 can also include a needle sleeve 19 coupled to the housing 11 to permit movement of the sleeve 19 relative to the housing 11. For example, the sleeve 19 can move in a longitudinal direction parallel to the longitudinal axis AA. Specifically, proximal movement of the sleeve 19 can permit the needle 17 to extend from a distal region D of the housing 11.

[0044] Insertion of needle 17 can occur via several mechanisms. For example, needle 17 can be fixedly positioned relative to housing 11 and can initially be positioned within extended needle sleeve 19. By placing the distal end of sleeve 19 against the patient's body and moving housing 11 distally, sleeve 19 is moved proximally to expose the distal end of needle 17. This relative movement allows the distal end of needle 17 to extend into the patient's body. This type of insertion is referred to as a "manual" insertion because the patient manually inserts needle 17 by manually moving housing 11 relative to sleeve 19.

[0045] Another form of insertion is "automatic," in which needle 17 moves relative to housing 11. Such insertion can be triggered by movement of sleeve 19 or by another form of actuation, such as button 13. As shown in FIGS. 1A and 1B, button 13 is located at the proximal end of housing 11. However, in other embodiments, button 13 can be located on the side of housing 11.

[0046] Other manual or automated functions can include injecting a medication or retracting the needle, or both. Injection is the process by which the bung or piston 14 is moved from a proximal position to a more distal position within the reservoir of the cartridge 18 to force the medication from the cartridge 18 through the needle 17. In some embodiments, a drive spring (not shown) is under compression before the device 10 is activated. The proximal end of the drive spring can be fixed within the proximal region P of the housing 11, and the distal end of the drive spring can be configured to apply a compressive force to the proximal face of the piston 14. After activation, at least a portion of the energy stored in the drive spring can be applied to the proximal face of the piston 14. This compressive force can act on the piston 14 to move it distally. This distal movement acts to compress the liquid medication within the cartridge 18, forcing the medication out of the needle 17.

[0047] After injection, needle 17 can be retracted into sleeve 19 or housing 11. Retraction occurs when the user removes device 10 from the patient's body and sleeve 19 moves distally. This occurs because needle 17 remains fixedly positioned relative to housing 11. Sleeve 19 can be locked once the distal end of sleeve 19 is moved past the distal end of needle 17, covering it. Such locking can include locking any proximal movement of sleeve 19 relative to housing 11.

[0048] Another form of needle retraction occurs when the needle 17 is moved relative to the housing 11. Such movement occurs when the cartridge 18 within the housing 11 is moved proximally relative to the housing 11. This proximal movement can be achieved by using a traction spring (not shown) located in the distal region D. The compressed traction spring, when activated, can provide sufficient force to move the cartridge 18 proximally. After sufficient retraction, any relative movement between the needle 17 and the housing 11 can be locked using a locking mechanism. Additionally, the button 13 or other components of the device 10 can be locked as desired.

[0049] 2, there is shown an embodiment of an injection device 20 of the present invention. The injection device 20 of the present invention is similar to the device 10 described above, and therefore configurations and components of the device 20 that are the same as configurations and components of the device 10 described above retain the same terminology and reference numbers.

[0050] The injection device 20 includes a housing 11 configured to receive a medicament container 18, i.e., a cartridge. The medicament container 18 can refer to a container that receives a medicament or a container that is at least partially filled with a medicament. The housing 11 is elongated and includes a proximal end P and a distal end D. The medicament container 18 is received in a distal region D' of the housing 11. That is, the medicament container 18 is disposed closer to the distal end D of the housing 11 than to the proximal end P of the housing 11.

[0051] For purposes of the following discussion, distal region D' may be considered to be the portion of housing 11 that is closer to distal end D of housing 11 than to proximal end P of housing 11. Proximal region P' of housing 11 may be considered to be the portion of housing 11 that is closer to proximal end P of housing 11 than to distal end D of housing 11.

[0052] 2 and 3, the housing 11 of the injection device 20 is shown partially see-through to more clearly show the internal components of the injection device 20. For clarity, some components of the injection device 20, such as the cap 12 and the needle sleeve 19, are not shown in Figures 2 and 3 for simplicity.

[0053] The injection device 20 further includes a plunger rod 21 that is longitudinally movable within the housing 11 between a priming position shown in FIG. 2 and a final position shown in FIG. 3. Preferably, the plunger rod 21 is disposed mostly, if not entirely, in the proximal region P' when in its priming position, and mostly in the distal region D' when in its final position. Thus, the plunger rod 21 is movable from the proximal region P' of the housing 11 to the distal region D' of the housing 11 as the injection progresses. In either case, the plunger rod 21 is disposed closer to the distal end D of the housing 11 when in its final position than when in the priming position.

[0054] The injection device 20 further includes a medication container 18. The plunger rod 21 includes a distal end 22 and a proximal end 23. The medication container 18 is received within the housing 11 between the plunger rod 21 and the distal end D of the injection device 20.

[0055] Plunger rod 21 includes stopper 14 disposed at its distal end 22. Stopper 14 is configured to contact the sidewall of drug container 18 to form a seal such that drug is forced out of container 18 through needle 17 when plunger rod 21 is moved longitudinally distally from the priming position toward the distal position.

[0056] The injection device 20 further includes an indicator 24. The indicator 24 is arranged in the proximal region P′ of the housing 11. Preferably, the indicator 24 is arranged in the region of the proximal end P. That is, preferably, the indicator 24 is arranged near, if not at, the proximal end P of the housing 11. The indicator 24 is configured to provide the user with information relating to the progress of the injection process depending on the longitudinal position of the plunger rod between the priming position and the completed position.

[0057] In this embodiment, the indicator 24 includes a display window 25. The display window 25 is disposed on a side wall of the housing 11. The display window 25 includes a distal end 28a and a proximal end 28b. The display window 25 is disposed in the proximal region P' of the housing 11. Preferably, the display window 25 is disposed entirely in the proximal region P' of the housing 11. Even more preferably, the display window is disposed near the proximal end P of the housing 11. That is, preferably, the proximal end 28b of the display window 25 is disposed next to the proximal end P of the housing 11. Locating the display window 25 near the proximal end P of the housing 11 allows the user to grip the injection device 20 closer to the distal end D of the housing 11, which improves stability of the device 20 during injection because the user's hand is closer to the injection site. Positioning the display window 25 near the proximal end P of the housing 11 also allows the user to hold the device 20 near its distal end D while still being able to view the indicator 24 and information related to the progress of the injection process, as shown in FIG. 4.

[0058] 2 and 3, display window 25 is shown as a rectangular aperture 27 in the side wall of housing 11. Display window 25 has a longitudinal axis that extends parallel to the longitudinal axis of housing 11. The longitudinal length of display window 25, i.e., the distance between distal end 28a and proximal end 28b, is substantially equal to the longitudinal distance that plunger rod 21 must move between its primed and finished positions.

[0059] It will be appreciated that the display window 25 may be any other shape, including but not limited to, triangular, circular, or curved. Furthermore, it will be appreciated that two or more display windows 25 may be disposed on a side wall of the housing 11, preferably spaced apart by a longitudinal gap. The display window 25 may include a cover 29, which is 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 view inside the device 20 through the display window 25. That is, the cover may be transparent or translucent.

[0060] Indicator 24 further includes a proximally extending protrusion 30. Protrusion 30 includes a distal end 31 and a proximal end 32. Protrusion 30 is coupled to plunger rod 21 and extends proximally away from plunger rod 21. Preferably, distal end 31 of protrusion 30 is coupled to plunger rod 21. Protrusion 30 is configured to be viewable through display window 25 at least when plunger rod 21 is in its priming position.

[0061] The protrusion 30 includes an outwardly facing surface 33 that is configured to be visible through the display window 25, at least when the plunger rod 21 is in its priming position. The outwardly facing surface 33 is disposed on a longitudinally extending arm 34 of the protrusion. Preferably, the distal end 31 of the protrusion 30 is coupled to the plunger rod 21 at a proximal region of the plunger rod 21, i.e., near the proximal end 23 of the plunger rod 21. The distal end 31 of the protrusion 30 can include a flange 35 that couples the distal end 31 of the arm 34 of the protrusion 30 to the proximal region of the plunger rod 21.

[0062] 2, protrusion 30 extends proximally such that a majority of protrusion 30 is positioned farther from distal end D of housing 11 than from the proximal end of plunger rod 21. That is, proximal ends 32 of arms 34 of protrusion 30 are spaced apart from proximal end 23 of plunger rod 21 and are positioned closer to proximal end P of housing 11.

[0063] Indicator 24 further includes an indication element 36. Indication element 36 is disposed in the same longitudinal position as display window 25. In some embodiments, indication element 36 can cover an area slightly larger than the area of ​​display window 25. Indication element 36 is also disposed radially inward of display window 25 and an arm 34 of protrusion 30 extending from plunger rod 21. Arm 34 of protrusion 30 is disposed between display window 25 and indication element 36. Arm 34 of protrusion 30 is configured to obstruct a user's view of indication element 36, at least when plunger rod 21 is in its primed position.

[0064] Protrusion 30 is axially coupled to plunger rod 21. Protrusion 30 is configured to move between a first indication position A, shown in FIG. 2, and a second indication position B, shown in FIG. 3, as plunger rod 21 is moved from the priming position, shown in FIG. 2, to the finished position, shown in FIG. 3. Thus, as plunger rod 21 moves longitudinally, protrusion 30 moves longitudinally a corresponding amount. Furthermore, as protrusion 30 moves from first indication position A toward second indication position B, a larger portion of indication element 36 is made visible through display window 25.

[0065] In one embodiment, when protrusion 30 is disposed in first indication position A, proximal end 32 of arm 34 of protrusion 30 is disposed at proximal end 28b of display window 25, as shown in FIG. 2. In such an embodiment, most of indication element 36 may be obstructed from view through display window 25 by arm 34 of protrusion 30, indicating that plunger rod 21 is in its primed position. In another embodiment, when protrusion 30 is disposed in first indication position A, only arm 34 of protrusion 30 may be visible through display window 25, indicating that plunger rod 21 is in its primed position.

[0066] In one embodiment, when the protrusion 30 is disposed in the second indicating position B, the proximal end 32 of the protrusion 30 is disposed at the distal end 28a of the display window 25. In such an embodiment, most of the indication element 36 can be visible through the display window 25. That is, when the protrusion 30 is disposed in the second indicating position B, only a small portion of the indication element 36 can be obstructed from view through the display window by the arm 34 of the protrusion 30, indicating that the plunger rod 21 is in its completed position. In another embodiment, when the protrusion 30 is disposed in the second indicating position B, only the indication element 36 can be visible through the display window 25, indicating that the plunger rod 21 is in its completed position, as shown in FIG. 3 . That is, when the protrusion 30 is disposed in its second indicating position B, the arm 34 of the protrusion 30 cannot be visible through the display window 25.

[0067] In one embodiment, plunger rod 21 is limited to purely longitudinal movement. In such an embodiment, protrusion 30 may be integrally formed with plunger rod 21. Alternatively, protrusion 30 may be fixedly attached to a proximal region of plunger rod 21. In such an embodiment, purely longitudinal movement of plunger rod 21 from the priming position shown in FIG. 2 to the finished position shown in FIG. 3 means that protrusion 30 moves only longitudinally and, therefore, remains aligned with display window 25 at all times during the injection process.

[0068] In another embodiment, plunger rod 21 can be rotatably moved during its longitudinal movement from the priming position to the finished position. In such an embodiment, protrusion 30 is non-rotatably decoupled from plunger rod 21 so as to remain aligned with display window 25 during the injection process. Thus, any rotational movement of plunger rod 21 does not cause rotation of protrusion 30, and therefore does not move protrusion 30 from the display window.

[0069] The protrusion 30 is restricted from longitudinal movement by a guide mechanism 40, shown in FIG. 3 . The guide mechanism 40 may include a guide element 41. The guide element 41 may be disposed on an 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 inward 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 the protrusion 30 from rotating away from the display window 25. One guide element 41 may be disposed on each side of the display window 25 to prevent rotation in both directions about the longitudinal axis.

[0070] The guide mechanism 40 may be used solely to prevent rotation of the protrusion 30 or of the protrusion 30 and plunger rod 21 when the protrusion is fixedly attached to the plunger rod 21 .

[0071] In embodiments in which the plunger rod 21 and the protrusion 30 are formed separately and later secured together, the protrusion 30 can further include a connecting element 44. The connecting element 44 is positioned opposite the arm 34 at the end of the flange 35. The connecting element 44 can include, for example, but is not limited to, a snap-fit ​​connection having two arms that fit around a proximal region of the plunger rod 21, or an annular ring that is positioned in a groove in the plunger rod 21. These types of connecting elements 44 allow for rotation of the plunger rod 21 relative to the protrusion 30.

[0072] In one embodiment, protrusion 30 may include an annular element (not shown) instead of longitudinally extending arms 34. The annular element may extend up to 360 degrees about the longitudinal axis, thereby preventing protrusion 30 from moving away from display window 25 as protrusion 30 rotates relative to plunger rod 21.

[0073] The outward arm 34 of the protrusion 30 and the indicator element 36 include different indicia configured to help the user determine the progress of the injection process at any given time. The outward arm 34 of the protrusion 30 includes a first indicia, and the indicator element 36 includes a second indicia that is different from the first indicia. The indicia may be, for example, but are not limited to, one or more colors, shades of colors, patterns, images, or numerical scales.

[0074] The injection device 20 can be mechanically driven. The indicator 24 can be a mechanical indicator. For example, the injection device 20 shown in FIGS. 2 and 3 includes a biasing element 46. In this embodiment, the biasing element is a helical spring 47. When the injection device 20 is actuated and the plunger rod 21 is free to move distally, the biasing element 46 biases the plunger rod 21 toward the distal end D of the housing 11. The spring 47 can abut the flange 35 of the protrusion 30 or the proximal end 23 of the plunger rod 21 to bias the plunger rod 21 toward its end position. Distal movement of the plunger rod 21 in the longitudinal direction also causes distal movement of the protrusion 30, moving the proximal end 32 of the arm 34 of the protrusion distally from the proximal end of the display window 25 toward the distal end 28a of the display window 25, and making the indication element 36 visible. As spring 47 expands further, proximal end 32 of projection 30 moves closer to distal end 28a of display window 25, making indication element 36 more visible.

[0075] In one embodiment, the housing 11 of the injection 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 in the distal region D' of the housing 11. That is, the second indicator is located proximate to the distal end D of the housing 11. The second display window 51 may also include a cover 54. When the plunger rod 21 is in its priming position and the medication container 18 is received in the housing 11, the medication container 18 is visible through the second display window 25.

[0076] As the plunger rod 21 is moved longitudinally toward the end position, the distal end 22 of the plunger rod 21 is moved along the second display window 51. When the plunger rod 21 is moved to its end position, the distal end 22 of the plunger rod 21 can be positioned at the distal end of the second display window 51.

[0077] Plunger rod 21, protrusion 30, and indication element 36 can include indicia. In one embodiment, plunger rod 21 and protrusion 30 can include a first indicia, and indication element 36 can include a second indicia that is different from the first indicia. In such an arrangement, the indicia indicate to the user the distance traveled by the movement of the first indicia through first and second display windows 25, 52 and by the increasing size of the area of ​​indication element 36 as plunger rod 21 is moved from its primed position to its completed position.

[0078] In an alternative embodiment, plunger rod 21 and indication element 36 can include a first indicia, and protrusion 30 can include a second indicia that is different from the first indicia. Preferably, the second indicia on protrusion 30 is similar to the appearance of the medication in medication container 18. In such an arrangement, the progress of the injection process is apparent to the user, as the second indicia indicates how far the plunger rod has traveled and the first indicia indicates how close plunger rod 21 is to completing the process.

[0079] 5 and 6, the injection device 20 can further include an outer sleeve 55. The outer sleeve 55 is configured to extend around the housing 11. Moreover, the outer sleeve 55 is configured to be longitudinally movable from a first position at the proximal end P of the housing 11 shown in FIG. 5 to a second position at the distal end D of the housing 11 shown in FIG. 6.

[0080] Referring now to Figure 5, when the outer sleeve 55 is in its first position, the second display window 51 and the medication container 18 in the housing 11 are visible, and 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.

[0081] The outer sleeve 55 can be moved by the user while the user is gripping the injection device 20. 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, so that when the user presses the distal end D of the device 20 against their body, the outer sleeve moves longitudinally towards the distal end of the housing 11 before the needle sleeve 19 is retracted. This ensures that the user holds the injection device 20 close to the distal end D of the housing 11 so as to improve the stability of the device 20 during the injection process.

[0082] 7 and 8, there is shown an embodiment of an injection device 110 of the present invention. The injection device 110 of the present invention is similar to the injection device 10 described above, and therefore configurations and components of the device 110 that are the same as configurations and components of the device 10 described above retain the same terminology and corresponding reference numbers.

[0083] The injection device 110 includes a housing 111 configured to receive a medicament container 118, i.e., a cartridge. The medicament container 118 can refer to a container that receives a medicament or is at least partially filled with a medicament. The housing 111 is elongated and includes a proximal end P and a distal end D. The medicament container 118 is received in a distal region D' of the housing 111. That is, the medicament container 118 is disposed closer to the distal end D of the housing 111 than to the proximal end P of the housing 111.

[0084] For purposes of the following discussion, distal region D' may be considered to be the portion of housing 111 that is closer to distal end D of housing 111 than to proximal end P of housing 111. Proximal region P' of housing 111 may be considered to be the portion of housing 111 that is closer to proximal end P of housing 111 than to distal end D of housing 111.

[0085] 7 to 10, the housing 111 of the injection device 110 is shown in schematic cross section to more clearly show the internal components of the injection device 110. For clarity, some components of the injection device 110, such as the cap 12 and the needle sleeve 19, are not shown in Figures 7 to 10 for simplicity.

[0086] The injection device 110 further includes a plunger rod 121 that is longitudinally movable within the housing 111 between a priming position, shown in FIG. 7, and a final position, shown in FIG. 8, in which the plunger rod 121 has substantially reached that position. Preferably, the plunger rod 121 is disposed mostly, if not entirely, in a proximal region P' when in its priming position, and is disposed mostly, if not entirely, in a distal region D' when in its final position. Thus, the plunger rod 121 is movable from the proximal region P' of the housing 111 to the distal region D' of the housing 111 as the injection progresses. In either case, the plunger rod 121 is disposed closer to the distal end D of the housing 111 when in its final position than when in the priming position.

[0087] The injection device 110 further includes a medicament container 118. The plunger rod includes a distal end 122 and a proximal end 123. The medicament container 118 is received within the housing 111 between the plunger rod 121 and the distal end D of the injection device 110.

[0088] Plunger rod 121 includes a stopper 114 disposed at its distal end 122. Stopper 114 is configured to contact a sidewall of drug container 118 to form a seal such that drug is forced out of drug container 118 through needle 117 when plunger rod 121 is moved longitudinally distally from the priming position toward the distal position.

[0089] The injection device 110 further includes an indicator 124. The indicator 124 is arranged in the proximal region P′ of the housing 111. Preferably, the indicator 124 is arranged in the region of the proximal end P. That is, preferably, the indicator 124 is arranged near, if not at, the proximal end P of the housing 111. The indicator 124 is configured to provide the user with information relating to the progress of the injection process depending on the longitudinal position of the plunger rod 121 between the priming position and the completed position.

[0090] Indicator 124 of injection device 110 includes a spindle 126. Spindle 126 includes an axis 127 and a dial 128. Dial 128 is configured to rotate to provide a user with information related to the progress of the injection process depending on the longitudinal position of plunger rod 121. Dial 128 includes a display surface 129. Display surface 129 of dial 128 provides information related to the progress of the injection process. Dial 128 is fixedly attached to axis 127 such that rotational movement of axis 127 rotates dial 128.

[0091] As shown in FIGS. 7 and 8 , the shaft 127 of the spindle 126 includes a distal end 131 and a proximal end 132. The shaft 127 is fixedly attached at its proximal end 132 to the dial 128. In this embodiment, the diameter of the dial 128 is larger than the shaft 127 of the spindle 126. The larger diameter of the dial 128 allows for a larger display surface 129 for providing information to the user related to the progress of the injection process. The dial 128 includes a distal surface 133 and an opposing proximal surface 134. The proximal surface 134 of the dial 128 faces away from the device 110. In this embodiment, the proximal surface 134 is the display surface 129. That is, the proximal surface 134 provides information related to the progress of the injection process.

[0092] Plunger rod 121 includes a first thread mechanism 135, and shaft 127 of spindle 126 includes a second thread mechanism 136. The second thread mechanism 136 of shaft 127 is configured to engage with the first thread mechanism 135 of plunger rod 121. As described in more detail herein below, the engagement of thread mechanisms 135, 136 with shaft 127 of plunger rod 121 and spindle 126 is configured such that as plunger rod 121 moves longitudinally from the priming position toward the completed position, shaft 127, and therefore dial 128, rotates to provide information to the user related to the progress of the injection process.

[0093] The spindle 126 is constrained in its longitudinal movement; that is, the spindle 126 is prevented from moving longitudinally. In some embodiments, the spindle 126 is prevented from moving longitudinally by the housing 111. There are many ways in which the housing 111 can be configured to prevent longitudinal movement of the spindle 126.

[0094] 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 positioned 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.

[0095] The housing 111 includes a longitudinally extending sidewall 138 that includes an end surface 139 at the proximal end P of the housing 111. 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 can include an end plate that extends across the proximal end P of the housing 111.

[0096] Additionally, dial 128 is positioned such that distal surface 133 of dial 128 contacts end surface 139 at the proximal end of housing 111. In this manner, as plunger rod 121 is moved longitudinally from the priming position toward the finished position, end surface 139 of housing 111 acts against distal surface 133 of dial 128, thereby preventing spindle 126 from moving longitudinally toward the finished position. In embodiments in which dial 128 is located at the proximal end of housing 111, proximal surface 134 of dial 128 is the proximal-most end of device 110.

[0097] Another exemplary configuration for preventing longitudinal movement of the spindle 126 includes a configuration in which the inner surface 142 of the housing 111 includes a groove (not shown) (143) with a protrusion (not shown) (144) extending from a side surface 145 of the shaft 127 or dial 128 disposed in the groove. Such a groove can prevent longitudinal movement of the spindle 126 from disengaging from the completed position. Alternatively, the protrusion 144 can extend from the inner surface 142 of the housing 111 into a groove 143 disposed in the side surface 141 of the shaft 127 or dial 128 of the spindle 126 shown in FIG. 10. In some embodiments, the protrusion can be formed by an end plate forming the end surface 139 of the housing 111.

[0098] 9, the dial 128 is positioned inside the housing 111 with a proximal surface 134 of the dial 128 facing outward from the housing 111 to provide the user with information related to the progress of the injection process. In such an embodiment, the dial 128 is preferably positioned 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.

[0099] The housing 111 further includes a cover 146. The cover 146 extends to cover the proximal face 134 of the dial 128. The cover 146 may also extend to cover the proximal end P of the housing 111. The cover 146 may include a peripheral protrusion 146a configured to be disposed in a groove 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 face 139 of the housing 111. In other embodiments, the cover 146 may form the proximal-most end of the injection device 110.

[0100] The cover 146 is configured to allow the dial 128 to provide the user with visual feedback related to the progress of the injection process. The cover 146 may be transparent or at least translucent to allow the user to view the dial 128 from above. In some embodiments, only a portion of the cover may be configured to allow the user to view the dial 128.

[0101] The dial 128 shown in Figures 7-9 can be configured in various ways to provide the user with visual feedback related to 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 alternative embodiments, the proximal surface 134 of the dial 128 can be flat. Additionally, the proximal surface 134 of the dial 128 can be uninterrupted; that is, the proximal surface 134 can be free of holes, depressions, or the like. In such embodiments, the proximal surface 134 of the dial 128 can include indicia configured to align with indicia on the proximal end of the side wall 138 of the housing 111.

[0102] For example, one of the proximal surface 134 and the side wall 138 can include an arrow pointing toward the periphery of the dial 128, and the other of the proximal surface 134 and the side wall 138 can include indicia that provide information related to the progress of the injection process, for example, but not limited to, by number scales, color shading, or words that represent events occurring during the injection process.

[0103] 11 , further exemplary embodiments of the dial 128 are shown. Referring to the embodiment shown in the upper right corner of FIG. 11 , the dial 128 may be at least partially see-through. That is, the entire dial 128 may be transparent or at least translucent so that a user can see through the dial 128. Alternatively, only a portion of the dial 128 may be transparent or translucent. The injection device 110 may further include a display plate 147 disposed on the housing 111 distal to the dial 128. The display plate 147 may include indicia on its proximal face 148, i.e., the face facing away from the injection device 110 and toward the dial 128. In the illustrated example, one of the dial 128 and the proximal face 148 of the display plate 147 includes an arrow 149, and the other of the dial 128 and the proximal face 148 includes indicia 151 in the form of words that represent events that occur during the injection process. As plunger rod 121 is moved longitudinally to its complete position, dial 128 rotates and arrow 149 changes events to provide the user with information relating to the progress of the injection process.

[0104] It will be appreciated that the axle 127 of the spindle 126 can pass through a central hole in the display plate 147. It will further be appreciated that the display plate 147 of the housing 111 can include a groove 143 or protrusion 144 that interacts with the axle 127 of the spindle 126 to prevent longitudinal movement of the spindle 126 during the injection process. It will further be appreciated that in some embodiments the display plate 147 can form the end surface 139 of the housing 111.

[0105] Referring briefly to the embodiment shown on the left of FIG. 11 , the dial 128 may include a cutout 152. The cutout 152 extends through the dial 128 from the proximal surface 134 to the distal surface 133, allowing the user to view the display plate 147 below the dial 128. The cutout 152 may be, for example, but not limited to, a sector shape. The dial 128 may also include a display window 153. The display window 153 is similar to a cutout in that it extends through the dial 128 from the proximal surface 134 to the distal surface 133, allowing the user to view the display plate 147 below the dial 128. The display window 153 may be, for example, but not limited to, a semicircular or crescent shape. However, the cutout 152 and display window 153 may be at different radial and angular positions on the dial 128 and may be used to provide different information about the progress of the injection process. With brief reference to the embodiment shown in the lower right of FIG. 11, it can be seen that the dial 128 can be formed with a plurality of cutouts 152 .

[0106] Both the cutout 152 and the display window 153 may include a cover 154 configured to be placed in the cutout 152 or the display window 153 to prevent debris from entering the housing 111 of the injection device 110. The cover 154 may be transparent or at least translucent to allow a user to see indicia located on the proximal surface 148 of the display plate 147 through the cover 154. The cover 154 may be formed by a transparent or translucent portion of the dial 128 rather than by an insert in the cutout 152 or the display window 153.

[0107] In the above embodiment, as dial 128 rotates relative to display plate 147, cutout 152 and / or window 153 are moved on proximal surface 148 of display plate 147 such that as the rotational position of cutout 152 and / or display window 153 changes, the indicia on proximal surface 148 of display plate 147 that are visible through cutout 152 and / or display window 153 also change. Thus, the changing indicia provides visual feedback regarding the progress of the injection process.

[0108] In the above embodiment, dial 128 includes cutout 152 and / or display window 153 to allow a user to view indicia located on proximal surface 148 of display plate 147. However, in alternative embodiments, cover 146 can include a transparent or at least translucent portion, and indicia can be located on proximal surface 134 of dial 128. Thus, as dial 128 rotates relative to the transparent portion of cover 146, the indicia on proximal surface 134 of dial 128 passes under the transparent portion of cover 146 to provide the user with information related to the progress of the injection process.

[0109] In some embodiments, instead of visual feedback, the dial 128 can be configured to provide the user with tactile feedback related to the progress of the injection process. An example of such an embodiment is shown in FIG. 10. In FIG. 10, the proximal surface 134 of the dial 128 includes a surface feature 156 configured to provide the user with tactile feedback related to the progress of the injection process. The surface feature 156 can be formed, for example, but not limited to, by one or more protrusions, one or more depressions, or surface undulations.

[0110] In a further embodiment of the injection device 110, the dial 128 can be housed inside the housing 111. The housing 111 can include a display window (158) in its side wall 138 through which a side 145 of the dial 128 can be viewed. The side 145 of the dial 128 can include indicia configured to provide a user with visual feedback related to the progress of the injection process.

[0111] 7 and 8, the plunger rod 121 is shown in threaded engagement with the axis 127 of the spindle 126. In this embodiment, the first thread feature 135 of 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 wall 162 and a longitudinally extending side wall 163. In this embodiment, the housing 161 is cylindrical, and therefore the side wall 163 is annular when viewed from the proximal end P of the housing 111. The tubular housing 161 includes an open proximal end 164 and an interior cavity 165. The interior cavity 165 is defined by an inner surface 166 of the side wall 163 and an inner surface 167 of the distal wall 162. The first screw mechanism 135 of the plunger rod 121 is formed on an inner surface 166 of a side wall 163 of the plunger rod 121 .

[0112] The plunger rod 121 is restricted in its longitudinal movement. That is, the plunger rod 121 can move longitudinally but is prevented from rotating about its longitudinal axis. The plunger rod 121 includes a protrusion 168 configured to be disposed in a groove in 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 a distance at least equal to the distance the plunger rod 121 must move between the primed position and the finished position. The sidewalls of the groove abut against the protrusion 168 of the plunger rod 121 to prevent rotation of the plunger rod 121 relative to the housing 111.

[0113] A cavity 165 formed in the plunger rod 121 is configured to at least partially receive the shaft 127 of the spindle 126. Preferably, when the plunger rod 121 is in its primed position, the distal end 131 of the shaft 127 abuts the inner surface 167, i.e., the proximal surface, of the distal wall 162 of the plunger rod 121. The shaft 127 of the spindle 126 includes a second thread feature 136 on an outer surface 171 of the shaft 127. The second thread feature 136 on the outer surface 171 of the shaft 127 of the spindle 126 is configured to threadably engage with the first thread feature 135 on the inner surface 166 of the plunger rod 121.

[0114] 7 and 8, the axis 127 of the spindle 126 is disposed inside the plunger rod 121. However, it will be appreciated that in alternative embodiments, the axis 127 of the spindle 126 can be disposed outside the plunger rod 121. In such embodiments, the first thread mechanism 135 can be disposed on the outer surface 169 of the plunger rod 121, and the second thread mechanism 136 would be disposed on the inner surface of the axis 127.

[0115] In this embodiment, the first screw mechanism 135 of the plunger rod 121 includes a continuous screw mechanism. That is, the continuous screw mechanism includes a continuous thread 172. The continuous screw mechanism extends from a distal end 173 of the inner surface 166 of the plunger rod 121 to a proximal end 174 of the inner surface 166 of the plunger rod 121. That is, the continuous first screw mechanism 135 extends along the length of the inner surface 166 of the plunger rod 121. Similarly, the second screw mechanism 136 of the shaft 127 of the spindle 126 includes a continuous screw mechanism. The continuous screw mechanism extends from a distal end 131 of the shaft 127 toward a proximal end 132 of the shaft 127. In this embodiment, the second screw mechanism 136 extends along the shaft 127 a distance equal to the length of the inner surface 166 of the plunger rod 121. Thus, the first and second screw mechanisms 135 and 136 are in contact throughout the longitudinal movement of the plunger rod 121 between the prime and finish positions.

[0116] The inner surface 166 of the side wall 163 of the plunger rod 121 determines the maximum longitudinal travel distance of the plunger rod 121 between the primed and finished positions. This is necessary because if the plunger rod 121 and spindle 126 lose their threaded engagement, the dial 128 will no longer be able to provide accurate information about the progress of the injection process. The continuous threads on the shaft 127 of the plunger rod 121 and / or spindle 126 are configured to ensure that the spindle 126 is constantly rotating as the plunger rod 121 is moved axially to provide continuous feedback about the progress of the injection process.

[0117] In some embodiments, the longitudinal length of the continuous thread on one of plunger rod 121 and axis 127 of spindle 126 is equal to the longitudinal distance between the primed position of plunger rod 121 and the completed position of plunger rod 121. This allows dial 128 of spindle 126 to provide feedback on the progress of the injection process depending on the position of plunger rod 121 anywhere between the primed and completed positions.

[0118] In other embodiments, the longitudinal length of the continuous thread on one of plunger rod 121 and axis 127 of spindle 126 is greater than the longitudinal distance between the prime position of plunger rod 121 and the completed position of plunger rod 121. This allows dial 128 of spindle 126 to provide feedback on the progress of the injection process depending on the position of plunger rod 121 before plunger rod 121 is moved to its prime position and / or after plunger rod 121 is moved to its completed position.

[0119] For example, the plunger rod 121 can have a loading position proximal to the priming position where 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 priming position where the bung 114 is in contact with the proximal end of the drug container 118.

[0120] 7 and 8, it can be seen that the injection device 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 one skilled in the art that any other type of biasing member 175 may be used. The helical spring 176 is arranged such that its longitudinal axis coincides with the longitudinal axis of the axis 127 of the spindle 126 and the longitudinal axis of the plunger rod 121. In this manner, the helical spring 176 extends around the axis 127 of the spindle 126, which may help prevent the spring 176 from bending out of alignment with the longitudinal axis when compressed.

[0121] Helical spring 176 includes a distal end 177 and a proximal end 178. Distal end 177 of helical spring 176 contacts proximal end 123 of plunger rod 121. Proximal end 178 of helical spring 176 contacts housing 111 at proximal region P'. In some embodiments, proximal end 178 of helical spring 176 can abut display plate 147, inner surface 142 of housing 111, or a protrusion extending from inner surface 142 of housing 111. When plunger rod 121 is in its primed position, biasing member 175 is in a more compressed state than when plunger rod 121 is in its completed position.

[0122] When the injection device 110 is actuated, a locking element preventing longitudinal movement of the plunger rod 121 is released, causing the biasing member 175 to expand from its compressed state. The proximal end 178 of the helical spring 176 is attached to the fixed housing 111, so that expansion of the spring 176 biases the distal end 177 of the spring 176, and thus the plunger rod 121, longitudinally distally. Distal movement of the plunger rod 121 is restricted to longitudinal movement by locating a protrusion 168 from the plunger rod 121 in a groove in the inner surface 142 of the housing 111.

[0123] Longitudinal movement of plunger rod 121 causes distal movement of first screw mechanism 135. Because spindle 126 is prevented from longitudinal movement, distal longitudinal movement of first screw mechanism 135 causes second screw mechanism 136 to slide relative to first screw mechanism 135, which rotates axis 127 of spindle 126 and, therefore, dial 128. Rotation of dial 128 provides feedback to the user of the progress of the injection process.

[0124] Referring briefly to FIG. 12 , another embodiment of the screw mechanism can be seen. In the alternative embodiment, the screw mechanism includes a discontinuous thread 181 on one of the plunger rod 121 and the shaft 127 of the spindle 126. In FIG. 12 , the first screw mechanism 135 on the inner surface 166 of the plunger rod 121 is a continuous thread 172. However, the continuous thread 172 extends only a short longitudinal distance at the proximal end of the plunger rod 121. The second screw mechanism 136 on the shaft 127 of the spindle 126 includes a discontinuous thread 181. The discontinuous thread 181 includes a proximal portion 182 and a distal portion 183.

[0125] Thus, as the plunger rod 121 moves longitudinally, the continuous first thread mechanism 135 of the plunger rod 121 engages the proximal portion 182 of the discontinuous second thread mechanism 136, rotating the dial 128 until the thread mechanisms are no longer in contact. Once the plunger rod 121 and shaft 127 are no longer threadably engaged, further longitudinal movement of the plunger rod 121 does not cause the dial 128 to rotate until the continuous first thread mechanism 135 of the plunger rod 121 engages the distal portion 183 of the discontinuous second thread mechanism 136, rotating the dial 128.

[0126] In such an embodiment, the discontinuous threads 181 are configured to provide event-specific feedback about the progress of the injection process, as indicated by discontinuous rotational movement of the dial 128 as the plunger rod 121 is moved longitudinally from a priming position to a completed position. For example, rotation by the proximal portion 182 of the discontinuous threads 181 can turn the dial 128 from an indication that the drug container 118 is loaded to an indication that the plunger rod 121 is in its priming position, and rotation by the distal portion 183 of the discontinuous threads 181 can turn the dial 128 from an indication that the plunger rod 121 is in its priming position to an indication that the plunger rod 121 is in its completed position.

[0127] In embodiments in which the first screw mechanism 135 includes discontinuous threads 181 and the second screw mechanism 136 includes continuous threads, the continuous threads can be disposed at the distal end 131 of the shaft 127.

[0128] It is further understood that in some embodiments, a continuous thread on one of the plunger rod 121 and the shaft 127 can be replaced by a protrusion extending into a continuous or discontinuous thread on the other of the plunger rod 121 and the shaft 127. In these embodiments, the pitch of the thread can be varied along the length of the screw mechanism. Increasing the pitch can reduce frictional forces with the threads because the angle of the threads is more closely aligned with the longitudinal direction of movement. Therefore, the pitch of the thread can be increased toward the distal end of the shaft 127 to reduce the force required by the biasing element 175 to move the plunger rod 121 longitudinally. The reduced force helps the spring 176 push the plunger rod 121 out as it extends. Alternatively, the pitch can be varied, i.e., reduced, in event-specific steps to rotate the dial 128 more quickly.

[0129] 13, it can be seen that in an alternative embodiment, the spindle 126 is hollow and open ended. In such an embodiment, the biasing member 175 can be housed in the hollow portion of the spindle 126. Thus, the distal end 175 of the spring 176 can contact the inner surface 166 of the distal wall 162 of the plunger rod 121.

[0130] In some alternative embodiments, the feedback provided by the dial 128 may include different types of feedback than those discussed above. For example, the feedback provided by the dial 128 may be, but is not limited to, a video, image, or video. The feedback may be intended to provide comfort to the user or recipient of the medication. In some embodiments, the dial may include a display for displaying the feedback. Alternatively, an image may be provided on the surface of the dial.

[0131] The feedback can be initiated when the device is activated. In some embodiments, the feedback can be initiated before the plunger rod is moved from the priming position, such as, but not limited to, when the cap is removed or the needle shield is retracted. In some embodiments, the feedback can be initiated at least 2 seconds before the plunger rod moves. More preferably, the feedback can be initiated at least 5 seconds before the plunger rod moves.

[0132] The feedback can end when the injection is complete. That is, the feedback can begin when the plunger rod is moved from the priming position and end when the plunger rod is in the completed position. In some embodiments, the feedback can end after the plunger rod reaches the completed position. The feedback can continue for a given period of time after the injection is complete. For example, the feedback can continue for at least 2 seconds after the injection is complete. More preferably, the feedback can continue for at least 5 seconds after the injection is complete.

[0133] Those skilled in the art will understand that the injection device 20 shown in Figures 2 to 6 may incorporate features described with reference to the injection device 111 shown in Figures 7 to 13, even if not explicitly described in the same embodiment. Furthermore, those skilled in the art will understand that the injection device 111 shown in Figures 7 to 13 may incorporate features described with reference to the injection device 20 shown in Figures 2 to 6, even if not explicitly described in the same embodiment. The embodiments are only described separately for clarity with respect to each feature, and the features shown in Figures 2 to 6 and the features shown in Figures 7 to 13 may be incorporated into the same injection device.

[0134] The terms "drug" or "pharmaceutical agent" 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 a 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, as well as nucleic acids, double- or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids, e.g., antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems, such as vectors, plasmids, or liposomes. Mixtures of one or more of these drugs are also contemplated.

[0135] The term "drug delivery device" is intended to encompass any type of device or system configured to administer a drug to a human or animal body. Without limitation, a drug delivery device can be an injection device (e.g., a syringe, pen injector, auto-injector, large volume device, pump, perfusion 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 pulmonary), an implant (e.g., coated stent, capsule), or a delivery system for the gastrointestinal tract. The drugs described herein may be particularly useful in injection devices that include a needle, e.g., a small gauge needle.

[0136] The drug or agent can be contained in a primary package or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other vessel configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more pharmaceutically active compounds. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber can be designed to store the drug for about one month to about two years. Storage can occur at room temperature (e.g., about 20°C) or refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the drug container can be or include a dual-chamber cartridge configured to separately store two or more components of a drug formulation (e.g., a drug and a diluent, or two different types of drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components of the drug or agent prior to and / or during administration to the human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and to allow mixing of the two components by a user, if desired, prior to administration. Alternatively or additionally, the two chambers can be configured to allow mixing upon administration of the components to the human or animal body.

[0137] The drug delivery devices and drugs described in the present invention can be used for the treatment and / or prevention of many different types of disorders. Exemplary disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, and thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further exemplary disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis.

[0138] Exemplary drugs for the treatment and / or prevention of diabetes or complications associated with diabetes include insulin, e.g., human insulin, or a human insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, or an analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or a mixture of any of them. As used herein, the term "derivative" refers to any substance that is sufficiently structurally similar to the original substance so as to have substantially the same functionality or activity (e.g., therapeutic effect).

[0139] Exemplary insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and the Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0140] 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-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29Lys B30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin. Exemplary GLP-1, GLP-1 analogs and GLP-1 receptor agonists include, for example, lixisenatide / AVE0010 / ZP10 / Lyxumia, exenatide / exendin-4 / Byetta / Bidurion / ITCA650 / AC-2993 (a 39 amino acid peptide produced by the salivary glands of the Japanese giant tiger moth), liraglutide / Victoza, semaglutide, taspoglutide, synclear / albiglutide, dulaglutide, rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langrena These include exenatide / HM-11260C, CM-3, GLP-1 Erigen, ORMD-0901, NN-9924, NN-9926, NN-9927, nodexen, Viadol-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, exenatide-XTEN, and glucagon-Xten.

[0141] An exemplary oligonucleotide is, for example, the cholesterol-lowering antisense therapeutic mipomersen / quinamro for the treatment of familial hypercholesterolemia.

[0142] Exemplary DPP4 inhibitors are vidagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0143] Exemplary hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropine (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0144] Exemplary polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low-molecular-weight heparin or ultra-low-molecular-weight heparin or derivatives thereof, or sulfated polysaccharides, such as the polysulfated forms of the aforementioned polysaccharides, and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low-molecular-weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives include Hylan G-F20 / Synvisc, sodium hyaluronate.

[0145] The term "antibody," as used herein, refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain antigen-binding ability. An antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single-chain antibody. In some embodiments, an antibody has effector function and is capable of fixing complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, antibody fragment, or mutant that does not support Fc receptor binding, e.g., with a mutation or deletion of the Fc receptor binding region.

[0146] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to antigen. Antibody fragments can include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present 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., diabodies, triabodies, tetrabodies), minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0147] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences and that are primarily responsible for maintaining the proper orientation of the CDR sequences to enable antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids within the CDRs to interact with the antigen.

[0148] 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).

[0149] The compounds described herein can be used in pharmaceutical formulations comprising (a) the compound or a pharmaceutically acceptable salt thereof, and (b) a pharmaceutically acceptable carrier. The compounds can also be used in pharmaceutical formulations containing one or more other active pharmaceutical ingredients, or in pharmaceutical formulations in which the compound or a pharmaceutically acceptable salt thereof is the only active ingredient. Thus, the pharmaceutical formulations of the present disclosure encompass any formulation made by mixing the compounds described herein with a pharmaceutically acceptable carrier.

[0150] Pharmaceutically acceptable salts of any of the drugs described herein are also contemplated for use in the drug delivery devices. Pharmaceutically acceptable salts include, for example, acid addition salts and basic salts. Acid addition salts include, for example, HCl or HBr salts. Basic salts include, for example, salts having a cation selected from alkali or alkaline earth metals, such as Na, K, or Ca, or ammonium ions N(R)(R)(R)(R), where R to R are independently hydrogen, an optionally substituted C-C alkyl group, an optionally substituted C-C alkenyl group, an optionally substituted C-C aryl group, or an optionally substituted C-C heteroaryl group. Further examples of pharmaceutically acceptable salts are known to those skilled in the art.

[0151] Pharmaceutically acceptable solvates are, for example, hydrates or alkanolates, such as methanolates or ethanolates.

[0152] Those skilled in the art will understand that modifications (additions and / or omissions) can be made to the various components, formulations, devices, methods, systems and embodiments of matter described herein without departing from the overall scope and spirit of the invention, and that the invention encompasses such modifications and all equivalents thereof.

[0153] This specification includes the following items:

[0154] Item 1. An injection device comprising: an elongated housing having a proximal end and a distal end and configured to receive a medication container; a plunger rod longitudinally movable within the housing between a priming position and a finished position and configured to be engageable with the medication container when received in the housing; Including, wherein the housing includes an indicator disposed in a proximal region of the housing; the indicator configured to provide a user with information related to the progress of the injection process depending on the longitudinal position of the plunger rod. Injection device.

[0155] Item 2. The injection device of item 1, wherein the indicator includes a spindle, the spindle including an axis and a dial, the dial configured to rotate to provide a user with information related to the progress of the injection process according to the longitudinal position of the plunger rod.

[0156] Item 3. The injection device of item 2, wherein the spindle is restricted in longitudinal movement and is rotatable relative to the plunger rod.

[0157] Item 4. The injection device according to item 2 or 3, wherein the spindle is prevented from moving longitudinally by the housing.

[0158] Item 5. The injection device according to any one of Items 2 to 4, wherein the dial is positioned at the proximal end of the housing such that, in use, the distal surface of the dial contacts the proximal end of the housing and the proximal surface of the dial faces outward from the device to provide the user with information related to the progress of the injection process.

[0159] Item 6. The injection device according to any one of Items 2 to 4, wherein the dial is positioned 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 related to the progress of the injection process.

[0160] Item 7. The injection device of any one of items 2 to 6, wherein the proximal surface of the dial includes a surface morphology configured to provide the user with tactile feedback related to the progress of the injection process.

[0161] Item 8. The injection device of item 6, wherein the housing includes a cover extending from a proximal end of the housing to cover a proximal face of the dial, the cover being configured such that the dial provides visual feedback to the user related to the progress of the injection process.

[0162] Item 9. The injection device of any one of items 2 to 4, wherein the dial is housed inside the proximal end of the housing, the housing further including a display window on a side thereof through which the side of the dial is viewable, and the side of the dial includes indicia configured to provide the user with visual feedback related to the progress of the injection process.

[0163] Item 10. The injection device according to any one of items 2 to 9, wherein the axis of the spindle includes a screw mechanism configured to engage with the screw mechanism of the plunger rod such that longitudinal movement of the plunger rod from the priming position toward the completion position rotates the dial of the spindle.

[0164] Item 11. The injection device of item 10, wherein the screw mechanism includes a continuous thread on at least one of the plunger rod and the spindle axis, the continuous thread configured to provide continuous feedback on the progress of the injection process.

[0165] Item 12. The injection device of item 10 or item 11, wherein the screw mechanism includes a discontinuous thread on one of the plunger rod and the spindle axis, the discontinuous thread configured to provide event-specific feedback about the progress of the injection process.

[0166] Item 13. The injection device according to item 11 or item 12, wherein the plunger rod is hollow and includes an open proximal end configured to receive the shaft of the spindle, the plunger rod including a thread on its inner surface, and the shaft including a thread on its outer surface.

[0167] Item 14. The injection device of any one of items 1 to 13, further comprising a medication container received within the housing between the plunger rod and the distal end of the injection device.

[0168] Item 15. A method of using the injection device according to item 1, comprising: actuating the injection device such that the plunger rod is moved longitudinally within the housing from a priming position to a finished position; Providing information related to the longitudinal position of the plunger rod using an indicator. A method comprising:

Claims

1. An injection device (20) comprising: an elongated housing (11) having a proximal end (P) and a distal end (D) and configured to receive a medication container (18); a plunger rod (21) longitudinally movable within the housing between a priming position and a finished position and configured to be engageable with the medication container when received in the housing; Including, wherein the housing includes an indicator (24) located in a proximal region (P') of the housing; the indicator: a display window (25) located in the proximal region (P') of the side wall of the housing; a proximally extending projection (30) extending from and coupled to the plunger rod (21), the proximally extending projection (30) being visible through the display window at least in the priming position; an indication element (36), wherein the protrusion (30) is positioned between the display window (25) and the indication element so as to prevent a user from viewing the indication element at least in the priming position; and Including, The injection device, wherein the protrusion is configured to move between a first indicating position and a second indicating position, and when the protrusion moves towards the second indicating position, a larger portion of the indication element (36) is made visible through the display window (25) to provide the user with information relating to the progress of the injection process depending on the longitudinal position of the plunger rod.

2. 2. The injection device (20) of claim 1, wherein the protrusion (30) is axially connected to the plunger rod (21) and is configured to move between a first indicating position and a second indicating position when the plunger rod is moved from the priming position to the completion position.

3. 3. The injection device (20) of claim 2, wherein when the protrusion (30) is in the first indication position, the proximal end (32) of the protrusion (30) is positioned at the proximal end (28b) of the display window (25).

4. 4. The injection device (20) of claim 3, wherein when the protrusion (30) is in the first indicating position, only the protrusion (30) is visible through the display window (25).

5. An injection device (20) according to any one of claims 2 to 4, wherein when the protrusion (30) is in the second indicating position, the proximal end (32) of the protrusion is positioned at the distal end (28a) of the display window (25).

6. 6. An injection device (20) according to claim 5, wherein when the protrusion (30) is in the second indicating position, only the indication element (36) is visible in the display window (25).

7. An injection device (20) according to any one of claims 1 to 6, wherein the protrusion (30) is non-rotatably decoupled from the plunger rod (21) so as to remain aligned with the display window (25) during the injection process.

8. 8. The injection device (20) of claim 7, wherein the inner surface (42) of the housing (11) includes a guide mechanism (40) configured to limit rotational movement of the protrusion (30) around the longitudinal axis of the plunger rod (21).

9. 9. The injection device according to claim 1, wherein the housing further comprises a second indicator in a distal region of the housing, the second indicator comprising a second display window, wherein the drug container is visible through the second display window when the plunger rod is in its priming position and the drug container is received in the housing, and wherein the distal end of the plunger rod is located at the distal end of the second display window when the plunger rod is moved longitudinally to the completed position.

10. 10. An injection device (20) according to claim 9, wherein the plunger rod (21) and the indication element (36) include the same indicia, and the protrusion (30) includes indicia that are different from the plunger rod and the indication element.

11. 11. The injection device (20) of any one of claims 1 to 10, further comprising an outer sleeve (55) configured to extend around the housing (11), the outer sleeve being longitudinally movable from a first position at a proximal end (P) of the housing, where the outer sleeve covers the indicator (24), to a second position at a distal end (D) of the housing, where the outer sleeve exposes the indicator.

12. An injection device (20) according to any one of the preceding claims, further comprising a drug container (18) received within the housing (11) between the plunger rod (21) and the distal end (D) of the injection device.

13. 10. A method for controlling the operation of an injection device according to claim 1, comprising: actuating the injection device such that actuation of the injection device moves the plunger rod (21) longitudinally within the housing from a priming position to a finished position; The protrusion of the indicator (24) moves between a first indicating position and a second indicating position to provide information related to the longitudinal position of the plunger rod (21). and showing a larger portion of the indication element of the indicator visible through the display window.

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