Syringe device

Abstract

The present invention relates to an injector device having a housing, a cartridge having a reservoir for a medicament, a needle unit comprising a needle, and an actuator. The needle unit is movably mounted to the housing and the reservoir is sealed relative to the needle prior to use of the injector device. The actuator is configured to move the needle unit into engagement with the cartridge such that the needle is moved into fluid communication with the reservoir. Threads are arranged to cause rotation of the needle unit when the needle unit is moved into engagement with the cartridge.

Description

[0001] This invention application is a divisional application of the invention patent application filed on November 30, 2018, with application number 201880077515.8 (international application number PCT / EP2018 / 083181) and entitled "Injector Device". Technical Field

[0002] This invention relates to a syringe device for pharmaceutical preparations. Background Technology

[0003] A cartridge injection device, such as a cartridge auto-injector, typically has a sealed cartridge containing a medication and a needle initially separated from the cartridge. An actuation motion moves the cartridge and needle together, causing the needle to pierce the cartridge. A plunger can then be moved into the cartridge to dispense the medication through the needle for injection into the user. Summary of the Invention

[0004] One object of the present invention is to provide an advantageous syringe device having a cartridge and a mechanism, the cartridge having a reservoir for a medicine initially sealed relative to a needle, the mechanism being used to move the needle into fluid communication with the reservoir prior to use.

[0005] According to the present invention, a syringe device is provided, comprising:

[0006] case,

[0007] A medicine container, which has a storage vessel for medicine.

[0008] The device includes a needle unit, which is movably mounted to a housing, and wherein the reservoir is sealed relative to the needle prior to use of the syringe device.

[0009] A needle sleeve, slidably mounted to the housing, allows the needle sleeve to slide into the housing during use of the syringe device. The needle sleeve is configured to engage the needle unit and push the needle unit into engagement with the cartridge, causing the needle to move into fluid communication with the reservoir.

[0010] The thread is adapted to cause the needle unit to rotate when it is pushed into engagement with the cartridge.

[0011] The thread can be provided between the needle unit and the housing and / or the cartridge. For example, the thread can be provided between the needle unit and the housing, or between the needle unit and the cartridge.

[0012] The threads can be arranged to connect the needle unit to the cartridge and / or housing after the needle unit has rotated.

[0013] In some examples, the housing includes a cartridge mounting portion surrounding at least a portion of the cartridge, and wherein threads are arranged between the needle unit and the cartridge mounting portion.

[0014] The cartridge mount may include threads, and the needle unit may include a threaded engagement member arranged to engage the threads. For example, the threaded engagement member may be a protrusion that engages the threads on the cartridge mount.

[0015] Alternatively, the cartridge mounting portion may include external threads, and the needle unit may include internal threads that engage with the external threads. In other examples, the needle unit may include external threads, and the cartridge mounting portion may include internal threads that engage with the external threads.

[0016] The cartridge mounting portion may further include a groove leading to the thread, and this groove may be arranged such that during the movement of the needle unit, the needle unit moves linearly before the threaded needle unit rotates. Thus, when the actuator actuates the needle unit, the threaded engagement member moves along the groove and then enters the thread, causing the needle unit to initially move linearly and then rotate.

[0017] The needle may include a needle axis, and the needle unit may be adapted to rotate about the needle axis.

[0018] In some cases, the needle sleeve covers the needle until the needle sleeve has pushed the needle unit into engagement with the cartridge. From this position, further movement of the needle sleeve exposes the needle for injection into the patient. The injection device may further include a spring arranged to push the needle sleeve into an extended position, such that after use, the needle sleeve slides out of the housing to cover the needle.

[0019] In some examples, the needle sleeve can be adapted to disengage from the needle unit after the needle unit has rotated, allowing the needle sleeve to move independently of the needle unit. In this way, the initial movement of the needle sleeve into the housing pushes the needle unit into engagement with the cartridge, and during this movement, the needle is rotated, causing the needle sleeve to disengage from the needle unit and continue moving independently of the needle unit into the housing.

[0020] After the needle unit has rotated, the movement of the needle sleeve into the housing can trigger the release of the medication. For example, the movement of the needle sleeve into the housing can cause a piston drive mechanism to drive a piston into the cartridge to dispense the medication from the needle. In one example, the piston drive mechanism includes a spring, a plunger, and a latch that holds the spring and plunger in a preloaded state. The movement of the needle sleeve into the housing releases the latch, causing the spring to push the plunger into the cartridge to dispense the medication.

[0021] The needle sleeve may include a flange that engages the needle unit, and the needle unit may include a recess arranged such that the flange aligns with the recess after the needle unit has been rotated. In this way, the needle sleeve can move on the needle unit.

[0022] Alternatively, the needle sleeve may include a helical engagement member, and the needle unit may include a protrusion engaging the helical engagement member, and the helical engagement member may be arranged such that a rotationally movable protrusion of the needle unit disengages from the engagement with the helical engagement member. In this way, the needle sleeve can move on the needle unit.

[0023] The needle sleeve may include a groove, and the needle unit may include a protrusion arranged to be received in the groove, such that the needle sleeve pushes the needle unit through the protrusion, and the groove may include a circumferential portion to allow the needle unit to rotate relative to the needle sleeve. In this way, the needle unit is able to rotate relative to the needle sleeve when it is pushed into the housing.

[0024] The groove may further include a movable portion arranged to allow the needle sleeve to slide into the housing after the needle unit has rotated.

[0025] The cartridge can hold the medicine in a storage container.

[0026] According to another aspect of the invention, a method of using a syringe device is also provided, wherein the syringe device includes a cartridge having a reservoir for a medicine, a needle unit including a needle that is sealed relative to the reservoir before use of the syringe device, and a slidably mounted needle sleeve.

[0027] The method includes:

[0028] The needle sleeve is slid into the housing, engaging the needle unit, and the needle unit is pushed into engagement with the cartridge, causing the needle to move into fluid communication with the reservoir.

[0029] When the needle unit is pushed into engagement with the cartridge, the needle unit rotates relative to the cartridge.

[0030] Specifically, the present invention relates to the following:

[0031] 1. A syringe device comprising:

[0032] case,

[0033] A medicine container, which has a storage vessel for medicine.

[0034] The syringe includes a needle unit movably mounted to the housing, wherein the reservoir is sealed relative to the needle prior to use of the syringe device.

[0035] An actuator configured to move the needle unit to engage with the cartridge, such that the needle moves into fluid communication with the reservoir, and

[0036] The thread is adapted to cause rotation of the needle unit when the needle unit moves to engage with the cartridge.

[0037] 2. The syringe device according to claim 1, wherein the thread is provided between the needle unit and the housing and / or the cartridge.

[0038] 3. The syringe device according to claim 1 or 2, wherein the threads are arranged to connect the needle unit to the cartridge and / or the housing after rotation of the needle unit.

[0039] 4. The syringe device according to any of the preceding claims, wherein the housing includes a cartridge mounting portion surrounding at least a portion of the cartridge, and wherein the threads are arranged between the needle unit and the cartridge mounting portion.

[0040] 5. The syringe device according to claim 4, wherein the cartridge mounting portion includes the thread, and the needle unit includes a threaded engagement member arranged to engage the thread.

[0041] 6. The syringe device according to claim 5, wherein the cartridge mounting portion further includes a groove leading to the thread, the groove being arranged such that the needle unit moves linearly during movement of the needle unit before the thread rotates the needle unit.

[0042] 7. The syringe device according to any of the preceding claims, wherein the needle includes a needle axis and the needle unit is adapted to rotate about the needle axis.

[0043] 8. The syringe device according to any of the preceding claims, wherein the needle sleeve is adapted to disengage from the needle unit after the needle unit has been rotated, such that the needle sleeve can move independently of the needle unit.

[0044] 9. The syringe device according to claim 8, wherein the needle sleeve includes a flange engaging the needle unit, and wherein the needle unit includes a recess arranged such that the flange aligns with the recess after the needle unit has been rotated.

[0045] 10. The syringe device according to claim 8, wherein the needle sleeve includes a helical engagement member, and the needle unit includes a protrusion engaging the helical engagement member, and wherein the helical engagement member is arranged such that rotational movement of the needle unit disengages the protrusion from engagement with the helical engagement member.

[0046] 11. The syringe device according to any one of claims 1 to 9, wherein the needle sleeve includes a groove, and the needle unit includes a protrusion arranged to be received in the groove such that the needle sleeve pushes the needle unit through the protrusion, and wherein the groove includes a circumferential portion to allow the needle unit to rotate relative to the needle sleeve.

[0047] 12. The syringe device according to claim 11, wherein the groove further includes a movable portion arranged to allow the needle sleeve to slide into the housing after rotation of the needle unit.

[0048] 13. The syringe device according to any of the preceding claims, wherein the cartridge contains a drug in the reservoir.

[0049] 14. A method of using a syringe device, wherein the syringe device includes a cartridge having a reservoir for a medicine, a needle unit including a needle that is sealed relative to the reservoir before use of the syringe device, and a slidably mounted needle sleeve.

[0050] The method includes:

[0051] The needle sleeve is slid into the housing, engaging the needle unit, and the needle unit is pushed into engagement with the cartridge, causing the needle to move into fluid communication with the reservoir.

[0052] When the needle unit is pushed into engagement with the cartridge, the needle unit rotates relative to the cartridge.

[0053] These and other aspects of the invention will become clear and elucidated with reference to the embodiments described below. Attached Figure Description

[0054] Embodiments of the invention will now be described by way of example only with reference to the accompanying drawings, wherein:

[0055] Figure 1A This is a schematic side view illustrating the syringe device and removable cap of the present invention;

[0056] Figure 1B This is when the cap is removed from the casing. Figure 1A A schematic side view of the syringe device;

[0057] Figure 2 This is a cross-sectional view of the syringe assembly;

[0058] Figures 3A to 3C This is a cross-sectional view of the needle tip of the syringe device, showing the operational phase of the syringe device;

[0059] Figure 4A and Figure 4B The needle unit of the syringe device is shown;

[0060] Figure 5 A partial cross-sectional view of the needle tip of the syringe device is shown;

[0061] Figure 6A and Figure 6B An alternative needle sleeve for syringe devices is shown;

[0062] Figure 7 An alternative needle sleeve for a syringe device is shown; and

[0063] Figure 8 An alternative needle unit for a syringe device is shown. Detailed Implementation

[0064] The drug delivery devices described herein can be configured to inject medication into a patient. Delivery can be subcutaneous, intramuscular, or intravenous. Such devices can be operated by a patient or caregiver (such as a nurse or physician) and can include various types of safety syringes, pen syringes, or autoinjectors. The device can include a cartridge-based system that requires penetration of a sealed ampoule before use. The volume of medication delivered using these different devices can range from about 0.5 ml to about 2 ml. Another type of device can include a high-volume device (“LVD”) or patch pump, configured to adhere to the patient’s skin for a period of time (e.g., about 5, 15, 30, 60, or 120 minutes) to deliver a “large” volume of medication (typically about 2 ml to about 10 ml).

[0065] In combination with specific medications, the devices described herein can also be customized to operate within required specifications. For example, the device can be customized to inject the medication over a specific time period (e.g., approximately 3 seconds to approximately 20 seconds for an autoinjector, and approximately 10 minutes to approximately 60 minutes for an LVD). Other specifications may include low or minimal levels of discomfort, or certain conditions related to human factors, shelf life, expiration date, biocompatibility, environmental factors, etc. Such variations can arise from various factors (e.g., the viscosity of the medication ranges from approximately 3 cP to approximately 50 cP). Therefore, medication delivery devices will typically include hollow needles ranging in size from approximately 25 to approximately 31 gauges. Common sizes are gauges 17 and 29.

[0066] The delivery device described herein may also include one or more automated functions. For example, one or more of the following may be automated: needle and cartridge assembly, needle insertion, drug injection, and needle retraction. Energy for one or more automated steps may be provided by one or more energy sources. Energy sources may include, for example, mechanical, pneumatic, chemical, or electrical energy. For example, mechanical energy sources may include springs, levers, elastomers, or other mechanical mechanisms that store or release energy. One or more energy sources may be combined into a single device. The device may further include gears, valves, or other mechanisms that convert energy into movement of one or more components of the device.

[0067] One or more automated functions of an autoinjector can be activated individually via an activation mechanism. This activation mechanism may include actuators, such as buttons, levers, needle sleeves, or other activating components. Activation of the automated function can be a one-step or multi-step process. That is, a user may need to activate one or more activation components to produce the automated function. For example, in a one-step process, a user may press the needle sleeve against their body to induce injection of a drug. Other devices may require multi-step activation of the automated function. For example, a user may need to press a button and retract the needle sheath to induce injection.

[0068] Furthermore, activation of one automated function may activate one or more subsequent automated functions, forming an activation sequence. For example, activation of the first automated function may activate at least two of the following: needle and cartridge assembly, needle insertion, drug injection, and needle retraction. Some devices may also require a specific sequence of steps to cause one or more automated functions to occur. Other devices may operate in a series of independent steps.

[0069] Some delivery devices may include one or more functions of a safety syringe, pen syringe, or autoinjector. For example, a delivery device may include a mechanical power source configured to automatically inject the drug (as typically found in autoinjectors) and a dosage setting mechanism (as typically found in pen syringes).

[0070] According to some embodiments of this disclosure, the exemplary drug delivery device 10 in Figure 1A and Figure 1B As shown in the figure. As described above, device 10 is configured to inject a drug into a patient. Device 10 includes a housing 11, which typically contains a cartridge defining a reservoir for containing the drug to be injected, and components necessary to facilitate one or more steps of the delivery process.

[0071] The device 10 may also include a cap 12 that can be detachably mounted to the housing 11. Typically, the user must remove the cap 12 from the housing 11 before the device 10 can be operated.

[0072] As shown in the figure, the shell 11 is generally cylindrical and has a substantially constant diameter along the longitudinal axis AA. The shell 11 has a distal region D and a proximal region P. The term "distal" refers to the position relatively closer to the injection site, and the term "proximal" refers to the position relatively farther away from the injection site.

[0073] The device 10 may also include a needle sleeve 19 coupled to the housing 11 to allow movement of the sleeve 19 relative to the housing 11. For example, the sleeve 19 may be movable in a longitudinal direction parallel to the longitudinal axis AA. Specifically, movement of the sleeve 19 in the proximal direction may allow the needle 17 to extend from the distal region D of the housing 11.

[0074] Insertion of the needle 17 can occur via several mechanisms. For example, the needle 17 can be fixedly positioned relative to the housing 11 and initially located within the extended needle sleeve 19. Proximal movement of the sleeve 19, achieved by placing the distal end of the sleeve 19 on the patient's body and moving the housing 11 in a distal direction, exposes the distal end of the needle 17. This relative movement allows the distal end of the needle 17 to extend into the patient's body. This type of insertion is referred to as "manual" insertion because the needle 17 is manually inserted by the patient manually moving the housing 11 relative to the sleeve 19.

[0075] Another type of insertion is "automatic," whereby pin 17 moves relative to housing 11. This type of insertion can be triggered by movement of sleeve 19 or by another activation method (such as, for example, button 13). Figure 1A and Figure 1B As shown, button 13 is located at the proximal end of housing 11. However, in other embodiments, button 13 may be located on one side of housing 11.

[0076] Other manual or automated features may include drug injection or needle retraction, or both. Injection is the process of moving the stopper or piston 14 from a proximal position to a more distal position within the reservoir of cartridge 18 to force the medication from cartridge 18 through needle 17. In some embodiments, a drive spring (not shown) is compressed before device 10 is activated. The proximal end of the drive spring may be fixed within the proximal region P of housing 11, and the distal end of the drive spring may be configured to apply a compressive force to the proximal surface of piston 14. Upon activation, at least a portion of the energy stored in the drive spring may be applied to the proximal surface of piston 14. This compressive force may act on piston 14 to move it in a distal direction. This distal movement is used to compress the liquid medication within cartridge 18, thereby forcing it out of needle 17.

[0077] After injection, the needle 17 can retract into the sleeve 19 or the housing 11. Retraction can occur when the user removes the device 10 from the patient's body, as the sleeve 19 moves distally. This can happen while the needle 17 remains fixedly positioned relative to the housing 11. Once the distal end of the sleeve 19 has moved past the distal end of the needle 17 and the needle 17 is covered, the sleeve 19 can be locked. Such locking can include locking any proximal movement of the sleeve 19 relative to the housing 11.

[0078] Another form of needle retraction can occur if the needle 17 moves relative to the housing 11. This movement can occur if the cartridge 18 within the housing 11 moves proximally relative to the housing 11. This proximal movement can be achieved using a return spring (not shown) located in the distal region D. The compressed return spring, when activated, can provide sufficient force to the cartridge 18 to move it proximally. After full retraction, any relative movement between the needle 17 and the housing 11 can be locked by a locking mechanism. Additionally, the button 13 or other components of the device 10 can be locked as needed.

[0079] Figure 2 An exemplary syringe device 20 is shown, having a housing 21, a cartridge 22, and a needle unit 23. The syringe device 20 further includes a piston 24, a piston drive mechanism 25, and a needle sleeve 26.

[0080] The cartridge 22 defines a reservoir 28 for containing the medicine and mounted within the housing 21. The distal end D of the cartridge 22 is sealed by an end cap 29. A cartridge mounting portion 30 of the housing 21 supports the cartridge 22. As shown, a portion of the cartridge mounting portion 30 is tubular and surrounds the distal end of the cartridge 22. The tubular portion of the cartridge mounting portion 30 has an outer surface disposed within the housing 21.

[0081] like Figure 2 As shown, in the initial state, the needle 31 of the needle unit 23 is spaced apart from the end cap 29 at the distal end of the cartridge 22, such that the reservoir 28 is sealed relative to the needle 31. Before or during use of the syringe device 20, the needle unit 23 moves to engage with the distal end of the cartridge 22, such that the needle 31 pierces the end cap 29 of the cartridge 22. In this way, the needle 31 is positioned in fluid communication with the reservoir 28, and the medication can be discharged from the reservoir 28 via the needle 31, as further explained below.

[0082] In the initial state, such as Figure 2As shown, piston 24 is disposed near the proximal end of reservoir 28 within cartridge 22, and piston drive mechanism 25 is disposed near the proximal end of housing 21. Piston drive mechanism 25 includes spring 32, plunger 33, and latch 34. Spring 32 is arranged to push plunger 33 against piston 24 and into cartridge 22 to dispense medication from reservoir 28 during use. As shown, in the initial state before use, spring 32 is held in a compressed state by latch 34. Specifically, latch 34 holds plunger 33, which keeps spring 32 in a compressed state, so that no force is applied to piston 24. In this state, piston drive mechanism 25 is preloaded.

[0083] As further explained below, the syringe device 20 is actuated by an actuator, in this example, a needle sleeve 26, which is rotatable and slidable within the housing 21 and protrudes from the distal end of the housing 21. Thus, during use, the needle sleeve 26 is placed against the user's skin, and while the user holds the housing 21, the syringe device 20 is pushed against the user's skin, which moves the needle sleeve 26 into the housing 21 in an axial proximal direction.

[0084] In other examples, the actuator may be a lever, a button, or a drive mechanism, such as a motor, which moves the needle sleeve 26 into the housing 21 in the axial direction.

[0085] Once the needle sleeve 26 has moved into the housing 21 in the proximal direction, the needle sleeve 26 actuates to release the latch 34. Once the latch 34 is released, the spring 32 pushes the plunger 33 against the piston 24 and into the reservoir 28.

[0086] like Figure 2 As shown, the latch 34 may include a tubular element 35 surrounding the plunger 33 and the spring 32. The tubular element 35 includes a protrusion 36 that engages a recess 37 in the plunger 33, such that... Figure 2 As shown, the protrusion 36 and the recess 37 prevent the plunger 33 from moving in the distal direction.

[0087] As the needle sleeve 26 moves proximally into the housing 21, one end of the needle sleeve 26 engages the tubular element 35, causing the tubular element 35 to rotate about the axis A of the syringe device 20. This rotation causes the protrusion 36 to disengage from the recess 37, thereby releasing the plunger 33, which then moves into the reservoir 28 under the force of the spring 32.

[0088] In one example, the end of the engagement tubular element 35 of the needle sleeve 26 may include a bevel (i.e., an angled edge) on the engagement tubular element 35 to cause rotation. In other examples, the tubular element 35 may include a bevel (i.e., an angled edge) engaged by a protrusion on the needle sleeve 26 to cause rotation.

[0089] In other examples, the latch 34 may include an arm comprising a protrusion that engages the plunger 33. In this case, the needle sleeve 26 can deflect the arm by lifting it, causing the protrusion to disengage from the recess, thereby releasing the plunger 33.

[0090] A biasing member, such as spring 42, may be arranged to act between housing 21 and needle sleeve 26 to push needle sleeve 26 in a distal direction, causing it to protrude from the distal end of housing 21.

[0091] Before or during use, before releasing the latch 34, the needle unit 23 engages with the cartridge 22. As described below, movement of the needle sleeve 26 in the axial proximal direction initially causes the needle unit 23 to engage with the distal end of the cartridge 22, and further movement of the needle sleeve 26 releases the latch 34, allowing the plunger 33 to begin delivering the medication via the needle 31.

[0092] Figures 3A to 3C The operation of the syringe device 20 is illustrated. In its initial state, as... Figure 3A As shown, the needle sleeve 26 is in an extended position, protruding from the distal end of the housing 21. A spring 42 pushes the needle sleeve 26 in the distal direction. As shown, the needle 31, supported by the needle unit 23, is spaced apart from the end cap 29 of the cartridge 22, such that the reservoir 28 is sealed relative to the needle 31. The needle 31 is centrally positioned such that it is aligned with the axis A of the syringe assembly 20. The distal end of the needle 31 is adapted to pierce the user's skin, and the proximal end of the needle 31 is adapted to pierce the end cap 29 of the cartridge 22 when the needle unit 23 engages the cartridge 22.

[0093] As shown in the figure, the needle unit 23 includes a needle body 38 that supports the needle 31 and defines a proximal recess 39 in the housing 21. As shown in the figure, the needle sleeve 26 includes an annular flange 40 that engages the distal end of the needle body 38, and the proximal end of the needle body 38 engages the cartridge mounting portion 30 of the housing 21.

[0094] Specifically, in this example, the needle body 38 is threadedly engaged with the cartridge mounting portion 30. The outer surface of the cartridge mounting portion 30 includes external threads, and the needle body 38 includes internal threads within a recess 39. In the initial state, the cartridge mounting portion 30 and the needle body 38 are partially threadedly engaged at the beginning of the threads, such that the needle 31 is spaced apart from the end cap 29 of the cartridge 22.

[0095] The needle sleeve 26 is mounted in the housing 21, allowing it to slide in the axial direction but not rotate. The needle unit 23 is mounted between the needle sleeve 26 and the housing 21, allowing it to rotate about the longitudinal axis A of the syringe assembly 20 and to move in the axial direction. The cartridge 22 is mounted to the cartridge mounting portion 30, fixing its position within the housing 21 and preventing it from rotating.

[0096] In this way, during use of the syringe device, the distal end of the needle sleeve 26 is placed against the user's skin and pushed downwards. For example... Figure 3B and Figure 3C As shown, this causes the needle sleeve 26 to move into the housing 21 in a proximal direction.

[0097] Figure 3B The diagram shows the intermediate position of the needle sleeve 26 during use. As shown, the movement of the needle sleeve 26 into the housing 21 has moved the needle unit 23 to engage with the cartridge mounting portion 30, and the needle 31 has pierced the end cap 29 of the cartridge 22, allowing fluid communication between the needle and the reservoir 28. The annular flange 40 of the needle sleeve 26 has pushed the needle body 38, causing the needle sleeve 26 and the needle unit 23 to move axially into the housing 21, thus engaging the needle unit 23 with the cartridge 22.

[0098] As described above, the needle body 38 and the cartridge mounting portion 30 are threaded together, therefore in Figure 3A The positions shown and Figure 3B During the axial movement between the indicated positions, the needle unit 23 rotates relative to the cartridge 22 and the housing 21. In particular, the needle unit 23 has rotated about axis A of the syringe assembly 20, which is aligned with the needle 31.

[0099] The threaded engagement between the needle body 38 and the cartridge mounting portion 30 can have a high-pitch thread, thus requiring less force to move the needle unit 23 axially when rotating it. In one example, the needle unit 23 is in its initial position ( Figure 3A Move to the middle position. Figure 3B During the process, it rotates approximately 90 degrees. In other examples, needle unit 23 rotates between 30 and 120 degrees.

[0100] In this example, needle unit 23 is in the initial position ( Figure 3A ) and middle position ( Figure 3B The rotation between the needle sleeve 26 and the needle body 38 causes the needle sleeve 26 to disengage from the needle body 38. Specifically, refer to... Figure 4A and Figure 4B The needle body 38 is shaped such that, after rotation, the needle sleeve 23 can pass over the needle body 38 in the axial direction.

[0101] like Figure 4B As shown, the needle body 38 includes a recess 41. Similarly, the annular flange 40 of the needle sleeve 26 includes segments and gaps between segments corresponding to the recess 41 in the needle body 38. In the initial position ( Figure 3A The annular flange 40 of the needle sleeve 26 aligns and engages with the non-recessed portion 43 of the needle body 38, allowing the needle sleeve 26 to push the needle unit 23 in the axial direction. Once the needle body 38 has rotated (due to the threaded engagement with the cartridge mounting portion 30...), Figure 3B The section of the annular flange 40 is aligned with the recess 41 in the needle body 38, allowing the needle sleeve 26 to pass over the needle body 38 in the axial direction, so that the needle sleeve 26 can move axially independently of the needle unit 23.

[0102] Therefore, as Figure 3C As shown, after reaching the intermediate position, the needle sleeve 26 continues to move axially, but the needle unit 23 does not move. In this way, the needle 31 is exposed and can pierce the user's skin. Figure 3C The position of the needle sleeve 26 has released the piston drive mechanism (25, see...) Figure 2 ) latch (34, see Figure 2 (See previous references) Figure 2 As stated, and piston (24, see Figure 2 It is pushed into the cartridge 22 to deliver the medicine through the needle 31.

[0103] After use, when the syringe device 20 is removed from the skin, the spring 42 pushes the needle sleeve 26 back to its initial position, so that the needle 31 is covered again.

[0104] exist Figure 3B As shown, the thread between the needle body 38 and the cartridge mounting part 30 locks the needle unit 23 onto the cartridge mounting part 30 of the housing 21.

[0105] Additionally, a locking member 44 may be provided to lock the needle unit 23 onto the cartridge mounting portion 30 of the housing 21. For example, the thread may include a notch 45 to... Figure 3B The protrusion 44 of the needle body 23 is positioned to receive the needle unit 23, thereby preventing rearward movement of the needle unit 23 in the distal direction. Alternatively, the housing, cartridge mount, and / or needle body may include one or more latches to lock the needle unit in place. Figure 3B and Figure 3C The location shown.

[0106] In the above example, during use, the needle unit 23 is initially rotated to engage with the cartridge mounting portion 30, and then disengages from the needle sleeve 26, allowing the needle sleeve 26 to continue axial movement to release the latch (34, see also). Figure 2 However, in an alternative example, when the needle sleeve 26 pushes the needle unit 23, the needle unit 23 can be adapted to initially slide axially toward the cartridge 22, and then the needle unit 23 rotates to engage with the cartridge mounting portion 30 and disengage from the needle sleeve 26.

[0107] Figure 5Another example of the engagement between the cartridge mounting portion 30 and the needle unit 23 is shown. In this example, the cartridge mounting portion 30 includes a slot 46, a groove 47, and a threaded section 48. The needle body 23 includes a protrusion 44 that sequentially engages the slot 46, the groove 47, and the threaded section 48 as the needle unit 23 moves axially toward the cartridge 22. Figure 5 The initial positions of the needle body 23 and the needle sleeve 26 are shown, which are equivalent to Figure 3A The location shown.

[0108] During use, as previously described, the needle sleeve 26 pushes the needle unit 23 in the axial direction, and the protrusion 44 is pushed out of the slot 46 and into the groove 47, which allows the needle unit 23 to move axially without rotating until the protrusion 44 encounters the threaded section 48, which then causes the needle unit 23 to rotate.

[0109] During axial and / or rotational movement, needle 31 has pierced the end cap 29 of cartridge 22, establishing fluid communication between needle 31 and reservoir 28. As previously described, rotation caused by threaded section 48 allows needle sleeve 26 to disengage from needle body 23, enabling needle sleeve 26 to continue its axial movement to release latch (34, see...) Figure 2 This triggers the delivery of the medication. The notch 46 helps ensure that the gap between the needle 31 and the cartridge 22 remains constant until a force is applied to the needle sleeve 26 when the syringe device 20 is put into use.

[0110] Figure 6A and Figure 6B Another example of the engagement between the needle sleeve 26 and the needle unit 23 is shown. In this example, the needle sleeve 26 includes a helical member 49 on its inner surface. The needle unit 23 includes a protrusion 50 on its outer surface, which engages with the helical member 49 of the needle sleeve 26 during use. Thus, the axial force applied to the needle sleeve 26 is transmitted to the needle unit 23 through the helical member 49 and the protrusion 50, pushing the needle unit 26 into engagement with the cartridge mount 30. The shape of the helical member 49 also contributes to the rotation of the needle unit 23 when the needle sleeve 26 pushes against the protrusion 50. As the needle unit 23 rotates due to the threaded engagement between the needle unit 23 and the cartridge mount 30, the protrusion 50 moves away from the engagement with the helical member 49, allowing the needle sleeve 26 to continue its axial movement without the needle unit 23. Specifically, as... Figure 6A As shown, during the axial movement of the needle sleeve 26 and the needle unit 23, the protrusion 50 engages the helical member 49 at position 50a. Then, as the needle unit 23 rotates, the protrusion 50 moves to position 50b and then to position 50c, where the protrusion 50 does not engage with the helical member 49, so that the needle sleeve 26 can move further in the axial direction independently of the needle unit 23.

[0111] In some examples, the needle sleeve 26 includes a single helical member 49, and the needle unit 23 includes a single protrusion 50. However, as... Figure 6B As shown, the needle sleeve 26 may include two helical members 49, and the needle body 23 correspondingly includes two protrusions 50. In other examples, the needle sleeve 26 may alternatively include three or more helical members 49.

[0112] Figure 6B An optional end stop 51 is also shown, which engages with the protrusion 50 once the desired amount of rotation is reached to prevent over-rotation. The end stop 51 is positioned such that the protrusion 50 can pass between the end of the helical member 49 and the end stop 51.

[0113] In similar Figure 6A and 6B In the alternative example shown, needle unit 23 may include one or more helical members 49, and needle sleeve 26 may include corresponding protrusions 50.

[0114] Figure 7 An alternative example of the engagement between the needle sleeve 26 and the needle unit 23 is shown. In this example, the needle sleeve 26 includes an "L"-shaped slot 52, and the needle unit 23 includes a protrusion 53 that engages the "L"-shaped slot 52. The "L"-shaped slot 52 is disposed on the peripheral wall of the needle sleeve 26. As shown, the "L"-shaped slot 52 has a circumferential portion 54 extending around the needle sleeve 26 in a circumferential direction, and an axial portion 55 extending in an axial direction along the needle sleeve 26.

[0115] In the initial position, protrusion 53 is located at the position indicated by 53a. In this position, when the needle sleeve 26 presses against the needle unit 23 through the circumference 54 of the "L"-shaped slot 52 and the protrusion 53, the needle sleeve 26 and the needle unit 23 move together axially. Then, when the needle unit 23 is screwed onto the thread of the cartridge mounting portion 30, protrusion 53 moves to the position indicated by 53b, and when protrusion 53 moves along the axial portion 55 to the position indicated by 55c, the needle sleeve 26 moves freely axially from there independently of the needle unit 21. Thus, rotation of the needle unit 23 causes the needle sleeve 26 to disengage from the needle unit 23, allowing the needle sleeve 26 to move axially on the needle unit 23 to expose the needle 31 and release the latch (34, see...). Figure 2 ).

[0116] Figure 8 An optional example needle unit 23 is shown. In this example, the needle body 38 includes an external thread 56, which is arranged to engage with an internal thread on a portion of the cartridge mounting portion 30 of the housing 21. This arrangement means that the needle body 38 has a smaller circumference, which reduces the torque required to rotate the needle unit 23 to thread engagement with the cartridge mounting portion 30.

[0117] It should be understood that, in various examples, the needle unit 23 may be rotatably connected to the cartridge mounting portion 30 (as previously described), the cartridge 22, or another part of the syringe assembly 20 fixed to the housing 21. For example, as Figure 2 As shown, the syringe device 20 may not include a cartridge mounting portion 30 extending from the end of the cartridge 22, so the cartridge 22 may include threads and the other features mentioned above.

[0118] In the example above, the needle sleeve 26 does not rotate as it moves axially into the housing 21. To achieve this, the housing 21 and the needle sleeve 26 include grooves and protrusions, such as tracks, which engage with each other to prevent the needle sleeve 26 from rotating relative to the housing 21.

[0119] In various examples, a resilient stop is provided between the needle unit 23 and the cartridge 22 or housing 21 to help prevent excessively forceful contact between the needle body 38 and the end cap 29 of the cartridge 22, which could lead to damage to the end cap 29.

[0120] The terms “drug” or “pharmaceutical preparation” are used synonymously herein and describe a pharmaceutical preparation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient (“API”) is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or pharmaceutical preparation is used to treat, cure, prevent, or diagnose a disease or to otherwise enhance physical or mental health. Drugs or pharmaceutical preparations may be used for a limited duration or periodically for chronic disorders.

[0121] As described below, a drug or pharmaceutical agent may include at least one API or combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, namely double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). Mixtures of one or more drugs are also considered.

[0122] Drugs or pharmaceutical preparations may be contained in primary packaging or "drug containers" adapted for use with drug delivery devices. Drug containers may be, for example, cartridges, syringes, reservoirs, or other robust or flexible vessels configured to provide suitable chambers for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chambers may be designed to store the drug for at least one day (e.g., from 1 day to at least 30 days). In some cases, the chambers may be designed to store the drug for about one month to about two years. Storage may occur at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, drug containers may be or may include dual-chamber cartridges configured to store two or more components (e.g., an API and a diluent, or two different drugs) of a pharmaceutical preparation to be administered, with one component stored in each chamber. In this case, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components before and / or during administration to a human or animal. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., through a conduit between the two chambers) and allow the user to mix the two components as needed before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing during dispensing of the components into a human or animal body.

[0123] The drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent many different types of medical conditions. Examples of barriers include, for example, diabetes or diabetes-related complications (such as diabetic retinopathy), thromboembolic barriers (such as deep vein or pulmonary thromboembolism). Other examples of barriers are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those described in the following manuals: such as Rote Liste 2014 (e.g., but not limited to, main group 12 (antidiabetic drugs) or 86 (oncology drugs)) and Merck Index, 15th edition.

[0124] Examples of APIs used to treat and / or prevent type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide-1 (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture thereof. As used herein, the terms “analyte” and “derivative” refer to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deletion and / or exchange of at least one amino acid residue present in a naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues may be codeable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. Specifically, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in a naturally occurring peptide may have been deleted and / or substituted with other amino acids (including non-coding amino acids), or amino acids (including non-coding amino acids) may have been added to a naturally occurring peptide.

[0125] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (glargine insulin); Lys(B3), Glu(B29) human insulin (glutamate insulin); Lys(B28), Pro(B29) human insulin (lispro insulin); Asp(B28) human insulin (aspart insulin); human insulin wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala and wherein Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0126] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (detemir insulin, B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (degludec insulin) ); B29-N-(N-lithochyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0127] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixilatin. Exenatide (Exendin-4, Liraglutide, a 39-amino acid peptide produced by the salivary glands of the Gila monster. Semaglutide, Taspoglutide, Albiglutide Dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langnatide / HM-11260C, CM-3, GLP-1Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, exenatide-XTEN, and glucagon-Xten.

[0128] Examples of oligonucleotides include, for instance, sodium mipronil. It is a cholesterol-reducing antisense agent used to treat familial hypercholesterolemia.

[0129] Examples of DPP4 inhibitors include vidagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0130] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, fertility-stimulating hormone), growth hormone (Somatropine), desmopressin, terlipressin, gosorelin, triptorelin, leuprorelin, buserorelin, nafarelin, and goserelin.

[0131] Examples of polysaccharides include glucosaminoglycane, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F20. It is a type of sodium hyaluronate.

[0132] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigens. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., murine) antibodies, or single-chain antibodies. In some embodiments, antibodies have effector function and can repair complement. In some embodiments, antibodies have reduced or no ability to bind to Fc receptors. For example, antibodies can be isotypes or subtypes, antibody fragments, or mutants that do not support binding to Fc receptors, for example, they have a mutagenic or missing Fc receptor-binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins with cross-binding region orientation (CODV).

[0133] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not contain the full-length antibody polypeptide but still includes at least a portion of the full-length antibody polypeptide capable of binding an antigen. Antibody fragments may include cleaved portions of the full-length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that can be used in this invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (such as bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., double-chain, triple-chain, and quadruple-chain antibodies)), monovalent or multivalent antibody fragments (such as bivalent, trivalent, quadruvalent, and multivalent antibodies), microantibodies, chelated recombinant antibodies, tri- or bispecific antibodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelified antibodies, and antibodies containing VHH. Further examples of antigen-binding antibody fragments are known in the art.

[0134] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term "frame region" refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides; it is not a CDR sequence and is primarily responsible for maintaining the correct positioning of the CDR sequence to allow antigen binding. Although frame regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the frame region of some antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0135] Examples of antibodies are anti-PCSK-9 mAbs (e.g., alirocumab), anti-IL-6 mAbs (e.g., sarilumab), and anti-IL-4 mAbs (e.g., dupilumab).

[0136] Pharmaceutically acceptable salts of any API described herein are also intended for use in drug delivery devices. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0137] Those skilled in the art will understand that various components / components of the APIs, formulations, instruments, methods, systems, and embodiments described herein may be modified (added and / or removed) without departing from the full scope and spirit of the invention, which covers including such modifications and any and all equivalents.

Claims

1. A syringe device comprising: case, A medicine container, which has a storage vessel for medicine. The syringe includes a needle unit movably mounted to the housing, wherein the reservoir is sealed relative to the needle prior to use of the syringe device. A needle sleeve, configured to move axially without rotation, to move the needle unit into engagement with the cartridge, such that the needle moves into fluid communication with the reservoir. A thread, adapted to cause rotation of the needle unit when the needle unit moves to engage with the cartridge; The needle sleeve is adapted to disengage from the needle unit after the needle unit has rotated, so that the needle sleeve can move independently of the needle unit.

2. The syringe device according to claim 1, wherein the thread is provided between the needle unit and the housing and / or the cartridge.

3. The syringe device according to claim 1 or claim 2, wherein the threads are arranged to connect the needle unit to the cartridge and / or the housing after rotation of the needle unit.

4. The syringe device of claim 1, wherein the housing includes a cartridge mounting portion surrounding at least a portion of the cartridge, and wherein the threads are arranged between the needle unit and the cartridge mounting portion.

5. The syringe device of claim 4, wherein the cartridge mounting portion includes the thread, and the needle unit includes a threaded engagement member arranged to engage the thread.

6. The syringe device of claim 5, wherein the cartridge mounting portion further includes a groove leading to the thread, the groove being arranged such that the needle unit moves linearly during movement of the needle unit before the thread rotates the needle unit.

7. The syringe device of claim 1, wherein the needle includes a needle axis and the needle unit is adapted to rotate about the needle axis.

8. The syringe device of claim 1, wherein the needle sleeve includes a flange engaging the needle unit, and wherein the needle unit includes a recess arranged such that the flange aligns with the recess after the needle unit has been rotated.

9. The syringe device of claim 1, wherein the needle sleeve includes a helical engagement member, and the needle unit includes a protrusion engaging the helical engagement member, and wherein the helical engagement member is arranged such that rotational movement of the needle unit disengages the protrusion from engagement with the helical engagement member.

10. The syringe device of claim 1, wherein the needle sleeve is slidably mounted to the housing such that, during use of the syringe device, the needle sleeve slides into the housing, the needle sleeve being configured to engage the needle unit and push the needle unit into engagement with the cartridge, such that, during use of the syringe device, when the needle sleeve presses against the injection site, the needle moves into fluid communication with the reservoir.

11. The syringe device of claim 1, wherein the needle sleeve includes a groove and the needle unit includes a protrusion arranged to be received in the groove such that the needle sleeve pushes the needle unit via the protrusion, and wherein the groove includes a circumferential portion to allow the needle unit to rotate relative to the needle sleeve.

12. The syringe device of claim 11, wherein the groove further comprises a movable portion arranged to allow the needle sleeve to slide into the housing after the needle unit has been rotated.

13. The syringe device of claim 1, wherein the needle sleeve is movable into the housing, and wherein the needle sleeve is configured such that an initial movement of the needle sleeve into the housing causes the needle unit to be pushed into engagement with the cartridge, and during the initial movement, the needle rotates to disengage the needle sleeve from the needle unit, such that the needle sleeve can continue to move into the housing independently of the needle unit.

14. The syringe device of claim 13, wherein after the needle has been rotated, the needle sleeve moves into the housing to trigger the release of the drug.

15. The syringe device of claim 14, wherein movement of the needle sleeve into the housing causes a piston drive mechanism to drive a piston into the cartridge to dispense medication from the needle.

16. The syringe device of claim 15, wherein the piston drive mechanism comprises a spring, a plunger, and a latch, the latch being configured to hold the spring and the plunger in a preloaded state, and wherein movement of the needle sleeve into the housing causes the latch to be released, thereby causing the spring to push the plunger into the cartridge to dispense the medication.

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