Injection device

Abstract

The present invention relates to an injection device having a housing (21), a cartridge (22) having a reservoir (28) for a medicament, a needle unit (23) having a needle (31), and a needle sleeve (26) rotatably mounted to the housing (21) about an axis (A). Prior to use of the injection device, the needle (31) is sealed from the reservoir (28), and at least one of the needle unit (23) and the cartridge (22) is axially slidably mounted to the housing (21). The needle sleeve (26) includes an engagement member (38) arranged to engage the needle unit (23) and / or the cartridge (22). The engagement member (38) is adapted such that rotation of the needle sleeve (26) axially moves the needle unit (23) and / or the cartridge (22) and moves the needle (31) into fluid communication with the reservoir (28). [Selected Figure] Figure 5B

Description

Technical Field

[0001] The present invention relates to an injection device for a medicament.

Background Art

[0002] For example, a cartridge-type injection device such as a cartridge-type auto-injector generally has a sealed cartridge that contains a medicament and a needle that is initially separated from the cartridge. Before using the injection device, the cartridge and the needle are combined such that the needle pierces the cartridge. Next, a plunger is moved into the cartridge to dispense the medicament through the needle for injection to the user.

Summary of the Invention

Problems to be Solved by the Invention

[0003] An object of the present invention is to provide a useful injection device having a cartridge that has a reservoir for a medicament that is initially sealed from a needle and a mechanism for moving the needle to be in fluid communication with the reservoir before use.

Means for Solving the Problems

[0004] According to the present invention, a housing, a cartridge having a reservoir for a medicament, a needle unit including a needle that is sealed from the reservoir before using the injection device, a needle sleeve rotatably mounted around an axis to the housing, are provided to include an injection device, at least one of the needle unit and the cartridge is slidably mounted axially to the housing, The needle sleeve includes an engagement member arranged to engage with the needle unit and / or the cartridge, and this engagement member is applied such that rotation of the needle sleeve moves the needle unit and / or the cartridge axially and moves the needle to put it in fluid communication with the reservoir.

[0005] In an example, the needle unit is slidably attached to the housing, and the engagement member of the needle sleeve moves the needle unit axially to move the needle to put it in fluid communication with the reservoir.

[0006] In another example, the cartridge is slidably attached to the housing, and the engagement member of the needle sleeve moves the cartridge axially to move the needle to put it in fluid communication with the reservoir.

[0007] In some examples, the needle sleeve is axially slidably attached to the housing, and after the needle sleeve rotates, the engagement member disengages from the needle unit and / or the cartridge, whereby the needle sleeve can move axially independently of the needle unit and the cartridge.

[0008] The injection device may further include a slot. This slot is arranged to prevent axial movement of the needle sleeve until the needle sleeve has finished rotating relative to the housing.

[0009] One of the housing and the needle sleeve includes a slot, and the other of the housing and the needle sleeve may include a protrusion applied to engage with this slot. The slot includes a peripheral portion for rotation of the needle sleeve and an axial portion for axial movement of the needle sleeve.

[0010] For example, the housing may include a slot, and the needle sleeve may include a protrusion applied to engage with this slot. In this case, the slot may include a peripheral portion for rotation of the needle sleeve and an axial portion for axial movement of the needle sleeve.

[0011] In another example, the needle sleeve may include a slot, and the housing may include a protrusion applied to engage with this slot. In this case, the slot may include a peripheral portion for rotation of the needle sleeve and an axial portion for axial movement of the needle sleeve.

[0012] The needle unit may include a needle body. The needle body is arranged to engage with the cartridge and / or the housing during axial movement of the needle unit and / or the cartridge.

[0013] For example, the needle body may engage with the end of the cartridge. Alternatively, the needle body may engage with the cartridge mounting portion of the housing. This cartridge mounting portion is close to the cartridge. In some examples, the housing includes a tubular cartridge mounting portion surrounding the end of the cartridge, and the needle body is arranged to engage with the tubular cartridge mounting portion.

[0014] The injection device may further include a guiding portion arranged to guide the needle unit and / or the cartridge to engage when the needle unit and / or the cartridge move axially. The guiding portion may further prevent rotation of the needle unit relative to the cartridge.

[0015] In some examples, the needle unit is axially slidably attached to the housing, and the cartridge is fixedly attached to the housing. In these examples, the needle body includes a guiding slot arranged to cooperate with a guiding rail, and this guiding rail may extend from the cartridge or the housing.

[0016] In some examples, the needle unit further includes a locking member. This locking member is arranged to lock the needle unit onto the cartridge or housing after the needle has moved into fluid communication with the reservoir due to the axial movement of the needle unit and / or the cartridge.

[0017] In some examples, the needle unit is axially slidably attached to the housing. In these examples, the needle unit includes a protrusion, and the needle sleeve may include a helical member. This helical member is arranged to engage with the protrusion to rotate the needle sleeve and move the needle unit axially.

[0018] In other examples, the cartridge is axially slidably attached to the housing. In these examples, the cartridge includes a protrusion, and the needle sleeve may include a helical member. This helical member is arranged to engage with the protrusion to rotate the needle sleeve and move the cartridge axially.

[0019] In these examples, the helical member is arranged such that rotation of the needle sleeve moves the helical member to disengage from the protrusion. In this way, the needle sleeve can move axially independently of the needle unit and the cartridge.

[0020] The injection device according to any one of claims 1 to 9 further includes a thread disposed between the needle unit and one of the cartridge or the housing. Rotation of the needle sleeve rotates the needle unit or the cartridge, and in this way, when the needle sleeve is rotated, the thread is applied to move the needle unit or the cartridge axially.

[0021] The cartridge may contain a drug in the reservoir.

[0022] In some embodiments, the needle sleeve is movable relative to the housing from an extended position where the needle sleeve covers the end of the needle to a retracted position where the end of the needle is exposed.

[0023] In some embodiments, when the needle sleeve is in the extended position, the distal end of the needle is located within the needle sleeve. In some embodiments, when the needle sleeve is in the retracted position, the end of the needle extends axially beyond the distal end of the needle sleeve. In some embodiments, when the needle sleeve is in the retracted position, the distal end of the needle is located outside the needle sleeve.

[0024] In some embodiments, the injection device includes a biasing member that biases the needle sleeve to the extended position. The biasing member may be a spring.

[0025] In some embodiments, the needle sleeve is generally tubular. The needle sleeve may be generally cylindrical.

[0026] In some embodiments, the injection device includes a cap. The cap is removably attached to the housing.

[0027] According to another aspect of the present invention, a cartridge having a reservoir for a medicament, a needle unit including a needle that is sealed from the reservoir before use of the injection device, a needle sleeve rotatably mounted about an axis to the housing, and also provides a method of using an injection device including: This method includes: rotating the needle sleeve about the axis and moving the needle unit and / or the cartridge axially such that the needle is moved into fluid communication with the reservoir.

[0028] These and other aspects of the present invention will become apparent and obvious from the following description of the embodiments.

[0029] Embodiments of the present invention will be described by way of example only with reference to the accompanying drawings.

Brief Description of the Drawings

[0030]

Figure 1A

Figure 1B

Figure 2

Figure 3

Figure 4A

Figure 4B

Figure 4C

Figure 5A

Figure 5B

Figure 5C

Figure 6

Figure 7A

Figure 7B

Mode for Carrying Out the Invention

[0031] The drug delivery devices described herein are configured to inject a medicament into a patient. For example, the delivery can be subcutaneous, intramuscular, or intravenous. Such devices can be operated by a patient, or a caregiver such as a nurse or physician, and can include various types of safety syringes, pen injectors, or auto-injectors. The device can include a cartridge-based system that requires piercing a sealed ampule prior to use. The volume of the medicament delivered by these various devices can range from about 0.5 to about 2 ml. Yet 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) and deliver a "large" volume (typically about 2 to about 10 ml) of the medicament.

[0032] The devices described herein can also be customized to operate within the required specifications with a particular medicament. For example, the device can be customized to inject the medicament within a particular time (e.g., about 3 to 20 seconds for an auto-injector, about 10 to about 60 minutes for an LVD). Other specifications can include specific conditions regarding low or minimal pain, or human factors, shelf life, expiration date, biocompatibility, environmental issues, etc. Such differences can result from various factors such as the viscosity range of the drug, which can be, for example, about 3 to about 50 cP. As a result, drug delivery devices often include hollow needles sized in the range of about 25 to about 31 gauge. Common sizes are 17 and 29 gauge.

[0033] The delivery devices described herein can also include one or more automated functions. For example, one or more of the coupling of the needle and the cartridge, the insertion of the needle, the injection of the drug, and the retraction of the needle can be automated. Energy for one or more of the automated processes can be provided by one or more energy sources. The energy source can include, for example, mechanical energy, pneumatic energy, chemical energy, or electrical energy. For example, a mechanical energy source can include a spring, a lever, an elastomer, or other mechanical mechanisms for storing or releasing energy. One or more energy sources can be combined in a single device. The device can further include gears, valves, or other mechanisms for converting energy into the movement of one or more components of the device.

[0034] One or more automated functions of the autoinjector are each activated via an activation mechanism. Such an activation mechanism can include an actuator, for example, one or more of a button, a lever, a needle sleeve, or other activation components. The activation of the automated function can be a single-step process or a multi-step process. That is, to effect the automated function, the user may need to activate one or more activation components. For example, in a single-step process, to inject the drug, the user may push down the needle sleeve relative to its body. In other devices, activation of multiple steps of the automated function may be required. For example, the user may be required to push a button and retract the needle shield to inject the drug.

[0035] Furthermore, the activation of one automated function may activate one or more subsequent automated functions, thereby forming an activation sequence. For example, the activation of a first automated function may activate at least two of the coupling of the needle and the cartridge, the insertion of the needle, the injection of the drug, and the retraction of the needle. Some devices may also require a specific sequence of steps to effect one or more automated functions. Other devices may operate with an independent sequence of steps.

[0036] Some delivery devices can include one or more functions of a safety syringe, a pen-type syringe, or an auto-injector. For example, a delivery device can include a mechanical energy source configured to automatically inject a drug (as is typically found in an auto-injector) and a dose setting mechanism (as is typically found in a pen-type syringe).

[0037] According to some embodiments of the present disclosure, an exemplary drug delivery device 10 is shown in FIGS. 1A and 1B. As described above, the device 10 is configured to inject a drug into a patient's body. The device 10 generally includes a housing 11 that encloses a cartridge that defines a reservoir containing the drug to be injected, and components necessary to facilitate one or more steps of the delivery process.

[0038] The device 10 can also include a cap 12 removably attached to the housing 11. Typically, the user must remove the cap 12 from the housing 11 before operating the device 10.

[0039] As shown, the housing 11 is substantially cylindrical and has a substantially constant diameter along the longitudinal axis A-A. The housing 11 has a distal region D and a proximal region P.

[0040] The term "distal" refers to a position relatively close to the site of injection, and the term "proximal" refers to a position relatively distant from the site of injection.

[0041] Device 10 can also include a needle sleeve 19 coupled to the housing 11, allowing 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 A-A. Specifically, proximal movement of the sleeve 19 enables the needle 17 to extend from the distal region D of the housing 11.

[0042] Insertion of the needle 17 is effected via several mechanisms. For example, the needle 17 is fixedly positioned relative to the housing 11 and initially located within the extended needle sleeve 19. Placing the distal end of the sleeve 19 against the patient's body and moving the housing 11 distally, causing proximal movement of the sleeve 19, will expose the distal end of the needle 17. Such relative movement enables the distal end of the needle 17 to extend into the patient's body. Since the needle 17 is manually inserted by the patient moving the housing 11 relative to the sleeve 19, such insertion is referred to as "manual" insertion.

[0043] Another form of insertion is "automatic", where the needle 17 automatically moves relative to the housing 11. Such insertion can be triggered by movement of the sleeve 19 or by another activation means, such as a button 13 for example. As shown in FIGS. 1A and 1B, the button 13 is located at the proximal end of the housing 11. However, in other embodiments, the button 13 can be located on the side of the housing 11.

[0044] Other manual or automatic functions can include drug injection and / or needle retraction, or both. Injection is the process by which the stopper or piston 14 is moved from a proximal position within the reservoir of the cartridge 18 to a more distal position to push the drug through the needle 17 from the cartridge 18. In some embodiments, a drive spring (not shown) is compressed 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 is applied to the proximal face of the piston 14. This compressive force acts on the piston 14 to move the piston 14 in the distal direction. Such distal movement serves to compress the liquid drug within the cartridge 18 and push it out of the needle 17.

[0045] After injection, the needle 17 can be retracted within the sleeve 19 or within the housing 11. Retraction can occur when the sleeve 19 moves distally when the user removes the device 10 from the patient's body. This can occur because the needle 17 remains in a fixed position relative to the housing 11. After the distal end of the sleeve 19 moves beyond the distal end of the needle 17 and the needle 17 is covered, the sleeve 19 is locked. Such locking can include locking any proximal movement of the sleeve 19 relative to the housing 11.

[0046] Another form of needle retraction can occur when the needle 17 is moved relative to the housing 11. Such movement can occur when the cartridge 18 within the housing 11 is moved in the proximal direction relative to the housing 11. This proximal movement can be achieved using a retraction spring (not shown) located in the distal region D. When activated, the compressed retraction spring can apply a force to the cartridge 18 sufficient to move the cartridge 18 in the proximal direction. After sufficient retraction, any relative movement between the needle 17 and the housing 11 is locked by a locking mechanism. Additionally, the button 13 or other components of the device 10 are locked as needed.

[0047] Figure 2 shows an example of an injection device 20 having a housing 21, a cartridge 22, a needle unit 23, and a needle sleeve 26. The injection device 20 further includes a piston 24 and a piston drive mechanism 25.

[0048] The cartridge 22 defines a reservoir 28 that contains a drug and is mounted within the housing 21. The distal end D of the cartridge 22 is sealed by an end cap 29. The cartridge attachment portion 30 of the housing 21 supports the cartridge 22. As shown, a portion of the cartridge attachment portion 30 is tubular and surrounds the distal end of the cartridge 22. This tubular portion of the cartridge attachment portion 30 has an outer surface disposed within the housing 21.

[0049] As shown in Figure 2, in the initial condition, the needle 31 of the needle unit 23 is spaced apart from the end cap 29 at the distal end of the cartridge 22. Before or during use of the injection device, the needle unit 23 is moved to engage the distal end of the cartridge 22 such that the needle 31 pierces the end cap 29 of the cartridge 22. In this way, as further described below, the drug can be discharged from the reservoir 28 through the needle 31.

[0050] In the initial condition, as shown in Figure 2, the piston 24 is disposed at the proximal end of the reservoir 28 within the cartridge 22, and the piston drive mechanism 25 is disposed at the proximal end of the housing 21. The piston drive mechanism 25 includes a spring 32, a plunger 33, and a catch 34. The spring 32 is arranged to bias the plunger 33 against the piston 24 and into the cartridge 22 to discharge the drug from the reservoir 28 during use. As shown, in the initial condition before use, the spring 32 is held in a compressed state by the catch 34. Specifically, the catch 34 holds the plunger 33, and the plunger 33 holds the spring 32 in a compressed state so that no force is applied to the piston 24. In this state, the piston drive mechanism 25 is preloaded.

[0051] As will be further described below, the injection device 20 is actuated by an actuator, in this example a needle sleeve 26. The needle sleeve 26 is rotatable and slidable within the housing 21 and projects from the distal end of the housing 21. Thus, during use, the needle sleeve 26 is placed against the user's skin, and the injection device 20 is pressed towards the user's skin while holding the housing 21, thereby moving the needle sleeve 26 proximally into the housing 21.

[0052] After the needle sleeve 26 has moved proximally into the housing 21, the needle sleeve 26 acts to release the catch 34. After the catch 34 is released, the spring 32 biases the plunger 33 against the piston 24 to force it into the reservoir 28.

[0053] As shown in Figure 2, the catch 34 may include a tubular element 35 that surrounds the plunger 33 and the spring 32. The tubular element 35 includes a protrusion 36 that engages a recess 37 within the plunger 33, such that in the position shown in Figure 2, the plunger 33 is prevented from moving distally by the protrusion 36 and the recess 37.

[0054] When the needle sleeve 26 is moved proximally into the housing 21, the end of the needle sleeve 26 engages the tubular element 35 and rotates the tubular element 35 about the axis A of the injection device 20. This rotation disengages the protrusion 36 from the recess 37, thereby releasing the plunger 33, which then moves into the reservoir 28 under the force of the spring 32.

[0055] In one example, the end of the needle sleeve 26 that engages the tubular element 35 can include a chamfer (i.e., an angled edge) that engages a protrusion on the tubular element 35 to rotate the tubular element 35. In other examples, the tubular element 35 can include a chamfer (i.e., an angled edge) that is engaged by a protrusion on the needle sleeve 26 to rotate the needle sleeve 26.

[0056] In other examples, the catch 34 can include an arm that includes a protrusion that engages the plunger 33. In this case, the needle sleeve 26 deflects the orientation of the arm by raising the arm, disengages the protrusion from the recess, thereby releasing the plunger 33.

[0057] A biasing member, such as a spring 42 for example, acts between the housing 21 and the needle sleeve 26 and is arranged to bias the needle sleeve 26 in the distal direction, whereby the needle sleeve 26 protrudes from the distal end of the housing 21.

[0058] Before or during use, the needle unit 23 is coupled to the cartridge 22 before the catch 34 is released. As described below, rotation of the needle sleeve 26 about axis A axially moves one of the needle unit 23 or the cartridge 22 within the housing 21, whereby the needle 31 is placed in fluid communication with the reservoir 28. A subsequent movement of the needle sleeve 26 in the proximal direction releases the catch 34 and the plunger 33 begins to deliver the drug through the needle 31.

[0059] Figure 3 shows the distal end of the injection device 20 without the needle unit 23. As shown, the needle sleeve 26 projects from the distal end of the housing 21. The needle sleeve 26 is slidably attached to the housing 21, whereby the needle sleeve 26 can move proximally into the housing 21. A spring 42 is arranged to bias the needle sleeve 26 in the distal direction, i.e., to the extended position. The cartridge 22 is attached within the housing 21. Specifically, the tubular cartridge attachment portion 30 of the housing 21 surrounds the distal end of the cartridge 22.

[0060] As shown, the needle sleeve 26 includes a helical guide 38 disposed on the inner surface of the needle sleeve 26, and the helical guide 38 extends partially around the inner peripheral edge of the needle sleeve 26. In an example, the needle sleeve 26 may include one or more, for example, two or three helical guides 38.

[0061] As shown in FIG. 3, the cartridge attachment portion 30 of the housing 21 includes a linear guide in the form of a rail 39 that extends axially along the cartridge attachment portion 30. As shown, the rail 39 may extend beyond the distal end of the cartridge attachment portion 30. The rail 39 is located on the outer surface of the cartridge attachment portion 30 within the housing 21.

[0062] Figures 4A - 4C show the needle unit 23 used with the housing 21, the needle sleeve 26, and the cartridge 22 of FIG. 3. As shown in FIG. 4A, the needle unit 23 includes a needle body 40 to which a needle 31 is attached. The needle body 40 includes a recess 41. The recess 41 is adapted to be positioned over the cartridge attachment portion 30 of the housing 21 (see FIG. 3) when the needle unit 23 is coupled to the cartridge 22 (see FIG. 3) during use of the injection device 20.

[0063] As shown in FIG. 4A and referring to FIG. 3, the needle body 40 includes a groove 43 arranged to cooperate with a rail 39 of the cartridge mounting portion 30 of the housing 21. The groove 43 is located on the inner surface of the needle body 40 within the recess 41. By the cooperation of the rail 39 and the groove 43, rotation of the needle unit 23 with respect to the housing 21 and the cartridge 22 is prevented, and as will be described below, when the helical guide 38 of the needle sleeve 26 presses the needle unit 23 onto the cartridge 22, the needle unit 23 is axially guided.

[0064] As shown in FIGS. 4B and 4C, the outer surface of the needle body 40 includes protrusions 44. In this example, the outer surface of the needle body 40 includes two protrusions 44, but it should be understood that one protrusion 44 is provided for each helical guide 38. The protrusions are generally circular, but may be of other shapes. The protrusions 44 are spaced equidistantly around the peripheral edge of the needle body 40.

[0065] Referring to FIGS. 3 and 4A - 4C, the protrusions 44 of the needle body 40 are arranged to engage with the helical guides 38 of the needle sleeve 26, and rotation of the needle sleeve 26 causes an axial movement of the needle unit 23 towards the cartridge 22. Thus, during use of the injection device 20, the user rotates the needle sleeve 26 to engage the needle unit 23 with the cartridge 22 and to place the needle 31 in fluid communication with the reservoir 28 before the injection process is initiated.

[0066] FIGS. 5A - 5C show the process of coupling the needle unit 23 and the cartridge 22.

[0067] As shown in FIG. 5A and also referring to FIGS. 3 and 4A-4C, in this initial position, the needle unit 23 is separated from the cartridge 22. The needle sleeve 26 is in the extended position and covers the needle 31. In this position, the needle unit 23 is held in a predetermined position by a combination of the engagement between the protrusion 44 and the spiral guide portion 38, the engagement between the proximal end of the needle body 40 and the cartridge mounting portion 30 of the housing 21, and the engagement between the rail 39 and the groove 43.

[0068] When the needle sleeve 26 is rotated, the engagement between the spiral guide portion 38 of the needle sleeve 26 and the protrusion 44 of the needle unit 23 axially drives the needle unit 23 toward the cartridge 22. The rail 39 and the groove 43 prevent the rotation of the needle unit 23 and guide the needle unit 23 onto the cartridge mounting portion 30.

[0069] As shown in FIG. 5A, the proximal end of the needle body 40 includes a catch 45 that first deflects the needle body 40 so that it moves over the cartridge mounting portion 30 of the housing 21. In the initial position, as shown in FIG. 5A, the engagement between the catch 45 and the cartridge mounting portion 30 helps to hold the needle unit 23 in a predetermined position within the injection device 20.

[0070] FIG. 5B shows the injection device 20 after the needle sleeve 26 has been rotated to move the needle unit 23 into engagement with the cartridge 22. As shown, the catch 45 at the proximal end of the needle body 40 engages with the recess 46 of the cartridge mounting portion 30, thereby fixing the needle unit 23 in a predetermined position of the cartridge mounting portion 30. Further, the proximal end of the needle 31 pierces the end cap 29 of the cartridge 22, whereby the needle 31 is in fluid communication with the reservoir 28. The needle sleeve 26 remains in the extended position by the action of the spring 42.

[0071] Rotation of the needle sleeve 26 disengages the helical member 38 from the protrusion (see 44 in FIGS. 4A-4C), whereby the needle sleeve 26 can move axially independently of the needle unit 23.

[0072] FIG. 5C shows the injection device 20 after being pressed against and pressed onto the user's skin to initiate the injection process. As shown, the needle sleeve 26 moves proximally into the housing 21 to expose the needle 31, whereby the needle 31 can pierce the user's skin. Further, as described above, the proximal movement of the needle sleeve 26 into the housing 21 releases the catch (see 34 in FIG. 2) of the piston drive mechanism (see 25 in FIG. 2) to release the plunger (see 33 in FIG. 2) and the spring (see 32 in FIG. 2), and then drives the piston (see 24 in FIG. 2) into the cartridge 22 to dispense the drug from the reservoir 28 through the needle 31.

[0073] After use, the spring 42 biases the needle sleeve 26 back to the extended position to cover the needle 31 again.

[0074] As shown in FIG. 6, to prevent the needle sleeve 26 from being moved proximally into the housing 21 before the needle sleeve 26 rotates and engages the needle unit 23 and the cartridge 22, the housing may include a protrusion 47 that engages a slot 48 in the needle sleeve 26, and the slot 48 and the protrusion 47 are arranged to allow only axial movement of the needle sleeve 26 after the needle sleeve 26 rotates.

[0075] In this example, the slot 48 is of the "L" shape and has a portion (not shown) extending in the peripheral direction and a portion 49 extending in the axial direction. In the initial position, the protrusion 47 of the housing 21 is located in the portion of the slot 48 extending in the peripheral direction, thereby enabling only the rotation of the needle sleeve 26. After the needle sleeve 26 rotates, the protrusion 47 is disposed in the portion 49 of the slot 48 extending in the axial direction, whereby the needle sleeve 26 can move axially toward the housing 21, exposing the needle 31 and triggering the piston drive mechanism (see 25 in FIG. 2).

[0076] It should be understood that in other examples, the needle sleeve 26 may include the protrusion 47 and the housing 21 may include the slot 48.

[0077] FIGS. 7A and 7B show an alternative example of the injection device 20. Specifically, FIG. 7A shows the distal end of the needle sleeve 26 and FIG. 7B shows the needle unit 23. The needle sleeve 26 in FIG. 7A and the needle unit 23 in FIG. 7B can be used with the injection device 20 in FIG. 3. However, in this example, the needle unit 23 is rotatably mounted within the housing 21 and there are no rails and grooves (39, 43) as described with reference to the previous example.

[0078] Referring to FIGS. 7A, 7B, and 3, the needle unit 23 has a needle body 50 having a recess 51 and a female thread in the recess 51. The female thread is arranged to engage with the male thread in the cartridge attachment portion 30 of the housing 21 or with the male thread in the cartridge 22. In the initial position, the threads are positioned or partially started so that rotation of the needle unit 23 (described below) causes the threads to move the needle unit 23 axially to engage with the cartridge 22. Thus, when the needle sleeve 26 is rotated, the threads serve to guide the needle unit 23 into engagement with the cartridge 22.

[0079] The inner surface of the needle sleeve 26 includes one groove 52, preferably two grooves 52. The outer surface of the needle body 50 includes one protrusion 53, preferably two protrusions 53, which engage with the grooves 52 of the needle sleeve 26. Thus, the rotation of the needle sleeve 26 within the housing 21 causes the rotation of the needle unit 23 within the housing 21, and the threads axially move the needle unit 23 to engage with the cartridge 22, whereby the needle 31 is placed in fluid communication with the reservoir 28.

[0080] As shown in FIG. 7B, the needle unit 23 may also include an end stopper 54. The end stopper 54 engages a portion of the cartridge attachment portion 30 after the needle unit 23 has been rotated onto the cartridge attachment portion 30 by the threads. Additionally or alternatively, a recess 55 may be provided to engage a catch of the cartridge attachment portion 30 to secure the needle unit 23 to the cartridge attachment portion 30.

[0081] The threaded connection between the needle unit 23 and the cartridge attachment portion 30 may have a high pitch, such that relatively few rotations are required to achieve the desired axial movement. For example, the rotation may be between 30° and 120°, or about 90°. However, the rotation may be greater than 120°, for example 180°.

[0082] In various examples, the threaded connection may include male threads of the cartridge attachment portion 30 and female threads of the needle unit 23. Alternatively, one of the female and male threads may be replaced by a protrusion arranged to engage the other thread, such that when the needle sleeve 23 rotates, the protrusion follows the path of the thread and moves the needle unit 23 to engage with the cartridge 22.

[0083] In this example, similar to what was described with reference to FIG. 6, the "L" - shaped slot and the protrusion are disposed between the housing 21 and the needle sleeve 26 to prevent the axial movement of the needle sleeve 26 before the needle sleeve 26 rotates and engages with the needle unit 23 and the cartridge 22.

[0084] In other examples similar to the above, the needle unit 23 is fixedly attached to the housing 21, and the cartridge 22 is axially slidably attached to the housing 21. In these examples, the rotation of the needle sleeve 26 axially moves the cartridge 22 to engage it with the needle unit 23.

[0085] For example, similar to the examples of FIGS. 3 - 5C, the needle unit 23 is fixedly attached to the housing 21, the cartridge 22 may be axially movable, and the helical guide portion 38 of the needle sleeve 36 is arranged to engage with the protrusion of the cartridge 22, whereby the rotation of the needle sleeve 26 axially moves the cartridge 22 distally to engage it with the needle unit 23. Similar to the examples of FIGS. 7A and 7B, the rotation of the needle sleeve 26 causes the rotation of the cartridge 22, whereby the screw connection between the cartridge 22 and the needle unit 23 axially moves the cartridge 22 distally to engage it with the needle unit 23.

[0086] Furthermore, in the examples described herein, the cartridge attachment portion 30 of the housing 21 surrounds the distal end of the cartridge 22 and is engaged by the needle unit 23 during use. However, it should be understood that the configuration and function of the cartridge attachment portion 30 are on the cartridge 22 itself. For example, the housing 21 does not surround the distal end of the cartridge 22, and the distal end of the cartridge 22 may include the configuration of the aforementioned cartridge attachment portion 30, such as a recess 46, threads, or a rail 39, etc.

[0087] The terms "drug" or "agent" are used interchangeably herein and refer to a pharmaceutical preparation comprising one or more pharmaceutical active ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally, a pharmaceutically acceptable carrier. A pharmaceutical active ingredient ("API") is, in the broadest sense, a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or agent is used for the treatment, therapy, prevention, or diagnosis of a disease, or alternatively, to improve physical or mental health. A drug or agent is used for a limited duration or, in the case of chronic diseases, periodically.

[0088] As described below, a drug or agent can comprise at least one API of one or more types of formulations, or a combination thereof, for treating one or more diseases. Examples of APIs can include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides, and proteins (such as 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 are incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0089] A drug or medicament is contained within a primary package or “drug container” that is adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other solid or flexible container configured to provide a chamber suitable for storage of one or more drugs (e.g., short-term or long-term storage). For example, in some cases, the chamber is 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 is designed to store the drug for from about one month to about two years. Storage can be at room temperature (e.g., about 20° C.) or refrigerated temperature (e.g., from about -4° C. to about 4° C.). In some cases, the drug container can be, or can include, a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different types of drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge are configured to allow mixing between the two or more components before and / or during dosing into a human or animal body. For example, the two chambers are configured such that they are in fluid communication with each other (e.g., by a conduit between the two chambers) and, if desired, allow the two components to be mixed by the user before dosing. Alternatively, or in addition, the two chambers are configured to allow mixing when the components are being dosed into a human or animal body.

[0090] The drugs or agents contained within the drug delivery devices described herein are used in the treatment and / or prevention of numerous different types of medical disorders. Examples of disorders include, for example, diabetes, or complications associated with diabetes such as diabetic retinopathy, thromboembolism such as deep vein thrombosis or pulmonary embolism. Another example of a disorder is acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs include, for example, but not limited to, those described in the Handbook Rote Liste 2014, main group 12 (antidiabetic drugs) or main group 86 (antineoplastic drugs), and the Merck Index, 15th edition, etc.

[0091] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes, or complications associated with type 1 or type 2 diabetes, include insulin, such as human insulin, or human insulin analogs or derivatives, glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof, dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof, or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure obtained formally from the structure of a natural peptide, such as the structure of human insulin, by deleting and / or replacing at least one amino acid residue found in the natural peptide and / or by adding at least one amino acid residue. The added and / or replaced amino acid residues can be codable amino acid residues, or other natural residues or fully synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure obtained formally from the structure of a natural peptide, such as the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are attached to one or more amino acids. Optionally, one or more amino acids found in the natural peptide may be deleted and / or replaced by other amino acids containing non-codable amino acids, or amino acids containing non-codable amino acids may be added to the natural peptide.

[0092] Examples of insulin analogs include Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala and Lys at position B29 is replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0093] Examples of insulin derivatives include, for example, B29-N-myristoyl-des(B30) human insulin; Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir (registered trademark)), B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin; B29-N-ω-carboxyheptadecanoyl-γ-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba (registered trademark)), B29-N-(N-lithocholyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin, and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0094] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Dyetta®, Bydureon®, a 39-amino acid peptide produced by the salivary gland of the Gila monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), r exendin-4, CJC-1134-PC, PB-1023, TTP-054, langlenatide / HM-11260C, CM-3, GLP-1 Eligen, 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.

[0095] Examples of oligonucleotides include, for example, mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia.

[0096] Examples of DPP4 inhibitors include vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0097] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists such as gonadotropins (folitropin, lutropin, chorionic gonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadorelin, tryptorelin, leuprolide, buserelin, nafarelin, and goserelin.

[0098] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or ultra-low molecular weight heparin, or derivatives thereof, or sulfated forms of the above polysaccharides, such as polysulfated forms, 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.

[0099] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind an antigen. Antibodies can be polyclonal, monoclonal, recombinant, chimeric, non-immune or humanized, fully human, non-human (e.g., murine), or single-chain antibodies. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has a low or no ability to bind to an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or variant that does not support binding to an Fc receptor, e.g., having a mutated or deleted Fc receptor binding region. The term antibody also includes antibody-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable domain antibody-like binding proteins (CODVs) having an orientation of the cross-linking region.

[0100] The term "fragment" or "antibody fragment" refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy chain and / or light chain polypeptide) that does not include the full-length antibody polypeptide but still includes at least a portion of the full-length antibody polypeptide that is capable of binding to an antigen. An antibody fragment can include a cleaved portion of the full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab’)2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific antibody fragments, or multispecific antibody fragments such as bispecific, trispecific, tetra-specific, and multi-specific antibodies (e.g., diabodies, triabodies, tetra-bodies), monovalent antibody fragments, or multivalent antibody fragments such as divalent, trivalent, tetravalent, and multivalent antibodies, minibodies, chelate recombinant antibodies, tribodies or biobodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Further examples of antigen-binding antibody fragments are known in the art.

[0101] The term "complementary determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that primarily play a role in mediating specific antigen recognition. The term "framework region" refers to the amino acid sequences within the variable regions of both heavy and light chain polypeptides that primarily play a role in maintaining the correct positioning of the CDR sequences and enabling antigen binding, rather than being the CDR sequences themselves. The framework region itself is not usually directly involved in antigen binding, as is known in the art, but specific residues within the framework region of a particular antibody can be directly involved in antigen binding or can affect the ability of one or more amino acids within the CDR to interact with the antigen.

[0102] Examples of antibodies include anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0103] Pharmaceutically acceptable salts of any API described herein are also contemplated for use of the drug or agent in a drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and basic salts.

[0104] One of ordinary skill in the art will understand that changes (additions and / or deletions) to the various components of the APIs, formulations, devices, methods, systems, and embodiments described herein can be made without departing from the scope and spirit of the invention, which includes such changes and all equivalents thereof.

Claims

**Claim 1** An injection device comprising: a housing, a cartridge having a reservoir for a medicament, a needle unit including a needle that is not in fluid communication with the reservoir before use of the injection device, a needle sleeve rotatably mounted about an axis to the housing and wherein at least one of the needle unit and the cartridge is axially slidably mounted to the housing, the needle sleeve includes an engagement member arranged to engage the needle unit, the engagement member being adapted such that rotation of the needle sleeve moves the needle unit axially and moves the needle into fluid communication with the reservoir, and the needle sleeve is movable relative to the housing from an extended position in which the needle sleeve covers an end of the needle to a retracted position in which the end of the needle is exposed, said injection device. **Claim 2** The needle sleeve is axially slidably mounted to the housing, and after rotation of the needle sleeve, the engagement member disengages from the needle unit, whereby the needle sleeve is axially movable independently of the needle unit and the cartridge, the injection device according to claim 1. **Claim 3** The needle sleeve includes a slot, and the housing includes a protrusion adapted to engage the slot, the slot being arranged to prevent axial movement of the needle sleeve until rotation of the needle sleeve relative to the housing is complete, the injection device according to claim 1 or 2. **Claim 4** The slot includes a peripheral portion for rotation of the needle sleeve and an axial portion for axial movement of the needle sleeve, the injection device according to claim 3. **Claim 5** The needle unit includes a needle body, the needle body being arranged to engage the cartridge during axial movement of the needle unit, the injection device according to any one of claims 1 to 4. **Claim 6** The injection device according to any one of claims 1 to 5, further comprising a rail arranged to guide the needle unit as it moves axially and engage the needle unit. **Claim 7** The rail prevents rotation of the needle unit relative to the cartridge, the injection device according to claim 6. **Claim 8** The needle unit is axially slidably mounted to the housing, the cartridge is fixedly mounted to the housing, the needle body includes a guide slot arranged to cooperate with a guide rail, and the guide rail extends from the cartridge. The injection device according to any one of claims 5 to 7.

9. The needle unit further includes a locking member, and the locking member is arranged to lock the needle unit onto the cartridge or the housing after the needle moves into fluid communication with the reservoir due to the axial movement of the needle unit. The injection device according to any one of claims 1 to 8.

10. The needle unit is axially slidably mounted to the housing, the needle unit includes a protrusion, the needle sleeve includes a helical member, and the helical member is arranged to engage with the protrusion to axially rotate the needle sleeve to move the needle unit. The injection device according to any one of claims 1 to 9.

11. The cartridge is axially slidably mounted to the housing, the cartridge includes a protrusion, the needle sleeve includes a helical member, and the helical member is arranged to engage with the protrusion to rotate the needle sleeve to axially move the cartridge. The injection device according to any one of claims 1 to 9.

12. The helical member is arranged such that rotation of the needle sleeve moves the helical member out of engagement with the protrusion. The injection device according to claim 10 or 11.

13. Further includes a thread disposed between the needle unit and one of the cartridge or the housing, wherein rotation of the needle sleeve is applied to rotate the needle unit or the cartridge such that the thread axially moves the needle unit when the needle sleeve is rotated. The injection device according to any one of claims 1 to 6.

14. The cartridge contains a drug in a reservoir. The injection device according to any one of claims 1 to 13.

15. The needle sleeve is movable relative to the housing from an extended position where the needle sleeve covers the end of the needle to a retracted position where the end of the needle is exposed. The injection device according to any one of claims 1 to 14.

16. A method of using an injection device, the injection device comprising: A cartridge having a reservoir for a medicament, A needle unit including a needle that is not in fluid communication with the reservoir before use of the injection device and a housing having a needle sleeve rotatably mounted about an axis, wherein the needle sleeve is movable relative to the housing from an extended position in which the needle sleeve covers the end of the needle to a retracted position in which the end of the needle is exposed, comprising The method comprises: rotating the needle sleeve about the axis and axially moving the needle unit and / or the cartridge such that the needle is moved into fluid communication with the reservoir.

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