Auto-injection instrument capable of giving doses for several times

Abstract

An autoinjector is configured to allow a user to suspend delivery of a medicament upon first activation of the autoinjector, and thereafter resume delivery of the medicament. The dose fractionated administration autoinjector may be operated to deliver a total desired dose of drug at multiple stages and / or at multiple injection sites.

Description

[0001] This patent disclosure claims priority to U.S. Provisional Application Nos. 63 / 486,420, filed February 22, 2023, and 63 / 556,511, filed February 22, 2024. The contents of the applications listed in this paragraph are expressly incorporated herein by reference in their entireties. Field of the Invention

[0002] The present disclosure relates generally to injectable drug delivery devices and corresponding methods and manufacture. More particularly, the present disclosure relates to injectable drug delivery devices configured to allow a user to self-administer a medicament at multiple injection stages and / or sites.

[0003] background

[0004] Any discussion of the prior art throughout the specification should in no way be considered as an admission that such prior art is widely known or forms part of the common general knowledge in the field.

[0005] The injectable drug delivery device designed for self-administration can enable patients to administer their own medication injections in non-clinical environments (e.g., at home) or any other environment where professional healthcare providers may not be able to provide help. Conventional syringes require users to provide the force required for administering injectable drugs. This force is characterized using the Hagen Poiseuille equation. In order to help users, self-administered drug delivery devices include a stored energy source, such as a compression spring, to provide the force required for injectable drugs. Less commonly, some self-administered drug delivery devices also rely on an electromechanical power source to drive the injection of the drug. The self-administered drug delivery devices of this category include automatic injection devices and wearable body injectors (patch pumps).

[0006] Since their introduction in the 1970s, automatic injection devices have been adapted to deliver an increasing number of drugs. The development of drugs and biologics (as injections) has placed increasingly higher demands on the performance of automatic injection devices. Due to, for example, high-concentration (higher concentration) biologics, larger injection volumes and / or long-acting formulations, drug formulations are becoming increasingly viscous. Higher drug formulation viscosities require higher injection forces or involve longer injection times. In most conventional spring-based automatic injection devices, a stronger spring would need to be employed, which in turn would result in an increase in the size of the automatic injection device. Larger automatic injection devices themselves are not compact, which may be undesirable from a user's perspective. In addition, larger automatic injection devices can cause instability during the injection procedure. It has been reported that spring-based automatic injection devices can break glass syringes filled with drugs. The impact amplitude of the spring on the glass syringe when the spring is released increases as the spring strength increases. Therefore, combining a stronger spring with a viscous formulation may be problematic.

[0007] Electromechanical-powered automatic injection devices can provide more compact devices while providing additional force for viscous preparations. However, these automatic injection devices can be expensive. Therefore, due to cost and disposal issues, these automatic injection devices are more practical as reusable automatic injection devices.

[0008] Recently, compressed gas has been used as a power source in automatic injection devices, including miniaturized compressed gas cylinders. However, these compressed gas automatic injection devices present many design challenges. Compressed gas cylinders are typically made of metal with welded seals. Breaking the welded seal releases gas, which is then directed to propel a plunger rod that slides within the hermetically sealed cylinder. The plunger rod, in turn, pushes a plunger stopper to inject the drug. Most disposable syringe automatic injection devices include this plunger rod.

[0009] Since the release of compressed gas involves breaking the weld seal, a high actuation force is required. Therefore, compressed gas automatic injection devices usually need to incorporate a lever actuator mechanism to make them practical. In addition, a large amount of piping is required to deliver the compressed gas to the plunger stop.

[0010] It is also important to ensure that the chamber in which the piercing pin used to break the weld seal operates is hermetically sealed and that the compressed gas is delivered to the syringe without leakage. Leakage of compressed gas during storage and during the injection step is a major problem with compressed gas powered automatic injection devices in the prior art. The compressed gas is typically an inert gas such as nitrogen, carbon dioxide, or argon. In some designs, the release of compressed gas can also result in recoil, which can cause the needle to be accidentally removed from the injection site.

[0011] When using a plunger rod propelled by compressed gas, the force applied to the plunger stop can be significant. If the applied force is not coaxial, the plunger rod may blow by the plunger stop, resulting in incorrect drug delivery, compromised container closure integrity, and / or damage to the automatic injection device during injection.

[0012] Maintenance of flow rate can be achieved by ensuring that the volume of drug is well below the total volume that the gas from the compressed gas source can occupy after it is punctured.Another approach is to add a biphasic gas to the compressed gas chamber.

[0013] Nevertheless, compressed gas as a power source still has significant advantages. Compared with compression springs, the power source has a compact size. In addition, as the injection volume increases and the syringe cross-section increases, the force available to drive the plunger stop in the syringe using a compressed gas source increases for the same pressure. Automatic injection devices with compressed gas power sources are more suitable for single use, which may be beneficial for some drugs.

[0014] The development of automatic injectors also depends on the changing user environment. The continued trend of treatment environments shifting from hospitals and clinics to patients' homes means that more people will use automatic injectors to treat their health conditions themselves. Therefore, a key design requirement for automatic injectors is to ensure that they can be used in an error-free manner.

[0015] In particular, new users of autoinjectors struggle to use them error-free. One study showed that 69% of participants, when operating without instructions, removed the autoinjector from the injection site prematurely, before the injection was complete. This is particularly problematic for infrequently injected medications, where patients may not have access to a replacement. This dose loss is caused by the fact that the needle safety mechanism activates immediately after the autoinjector is removed from the injection site. Even if the needle safety shield is locked, the drug is expelled from the autoinjector. This lockout occurs regardless of whether the full dose has been administered. Addressing this technological gap could alleviate the significant burden of treatment adherence.

[0016] Furthermore, there is growing consideration of shifting injectable medications from the hospital to the home setting. Intravenous administration requires a skilled healthcare professional to set up. On the other hand, subcutaneous or intramuscular injections can be self-administered at home or by a caregiver. Therefore, being able to administer current medications that are currently administered intravenously subcutaneously or intramuscularly could facilitate the transition of therapeutic delivery from the hospital to the home setting. This would be a significant benefit for both the healthcare system and patients. The volume of medication injected intravenously is higher than that typically injected subcutaneously or intramuscularly. Therefore, shifting from intravenous administration would require concentrating the drug solution to reduce the injection volume, which in turn could significantly increase the viscosity of the drug solution, but still involve a larger injection volume than is typically injected in the subcutaneous or intramuscular space. Hyaluronidase has been used to facilitate the injection of larger volumes in the subcutaneous space by temporarily breaking down components of the subcutaneous tissue. This requires the drug to be co-formulated with the enzyme, resulting in additional complexity and cost.

[0017] The ability of the automatic injection device to pause the injection can enable the dose to be injected in multiple subcutaneous (or intramuscular) injection sites without causing the patient discomfort due to large-volume injections. Although the injection regimen can be used with or without the use of co-formulated hyaluronidase, the pause feature in the automatic injection device provides the option of large-dose delivery without the need for hyaluronidase. Another benefit of splitting and delivering the dose across multiple injection sites is improved pharmacokinetics, resulting in faster bioavailability due to a higher injection area to volume ratio at each injection site. Intentional deployment of the disclosed InjectionPause TM (injection pause) feature to facilitate large volume injection in the subcutaneous or intramuscular space can enable a shift from intravenous to subcutaneous or intramuscular, and therefore enable a shift in drug delivery from the hospital to the home (non-hospital) setting.

[0018] There are currently two types of automatic injection devices, i.e., single-use (or disposable) automatic injection devices and reusable automatic injection devices. The pause feature can also enable another type of automatic injection device, i.e., multiple-use automatic injection devices. This multiple-use automatic injection device must include a pre-filled cartridge as a primary container. The automatic injection device will include a stop dose corresponding to the ratio of the total drug filled in the barrel. This ratio will be equal to the indicated dose that needs to be delivered. At the dose stop, the injection needle is configured to be removed from the cartridge, or the mechanism (compressed gas or compression spring) providing the injection force is dissipated or offset by at least an equal opposing force. Multiple-use automatic injection devices have significant sustainability advantages, without the cost disadvantages of reusable automatic injection devices.

[0019] The automatic injection device comprises a drug container, which is pre-filled with the drug to be injected into the patient. The drug container is typically a pre-filled syringe or a pre-filled barrel. Considering that the drug should be proven to be compatible with the drug container within its expected shelf life, the process of making the automatic injection device usable as a pre-filled syringe or barrel requires great effort. Careful effort may be required to effectively integrate the pre-filled drug container (syringe or barrel) with the single-use automatic injection device.

[0020] Given the investment required to undertake the activities described, automatic injectors are currently only used for drug molecules in later stages of development (i.e., Phase 3 or at launch, or as part of the post-approval lifecycle management of a drug).

[0021] Automatic injection devices offer numerous benefits to users and healthcare systems, enabling medication administration away from hospitals or requiring healthcare professionals. However, these benefits are unavailable in situations where automatic injection devices are unavailable due to financial barriers or drug incompatibility with the medication container. Furthermore, automatic injection devices could facilitate the administration of medications that are difficult to inject manually, such as viscous medications. These medications require reformulation to continue development or be discontinued.

[0022] Automatic injection devices that do not require investment or effort to establish long-term drug-container compatibility and simplify drug filling and integration operations would provide the opportunity to introduce automatic injection device drug delivery device options earlier in the drug development cycle, or for drugs that will never be available in a prefilled form.

[0023] Therefore, an automatic injection device that can effectively deliver a wide range of pharmaceutical dosages, provide the flexibility of staged delivery, reduce user error, and accommodate cost and drug-container compatibility requirements would be advantageous. SUMMARY OF THE INVENTION

[0025] It is an object of the present invention to overcome or ameliorate one or more disadvantages of the prior art, or at least provide a useful alternative.

[0026] The present invention includes an injectable drug delivery device configured to allow a user to self-administer a medicament in a staged delivery. TM The delivery mode facilitates the choice of conventional delivery of the total available dose in one phase at one injection site or the flexibility to deliver the total available dose in multiple phases (dose fractioning) and / or multiple injection sites. This capability also allows for delivery of the total available dose at multiple injection sites in the same time period or multiple injections over multiple days. Injection Pause TMThe deliverability has the added benefit of increasing the probability that a user, who is typically inexperienced in operating an automatic injection device, will administer the full prescribed dose despite being unfamiliar with operating the automatic injection device.

[0027] The automatic injection device disclosed herein provides a cartridge having a needle that is introduced into the cartridge just before a dose is delivered. To ensure that the cartridge entry point is sterilized before the needle pierces the cartridge septum to access the encapsulated medication, a reservoir of disinfectant (e.g., isopropyl alcohol) is disposed between the needle and the cartridge septum. The reservoir has a removable seal disposed on the side of the cartridge septum. The reservoir is part of a needle shield subassembly. Upon removal of the seal, the reservoir contents (disinfectant) contact the cartridge septum. When the user removes the cap, the seal can be removed, thereby exposing the disinfectant and optionally contacting the cartridge septum simultaneously. Axially opposite is another seal that is pierced by the non-patient end of the injection needle when the needle shield is retracted.

[0028] The needle is secured by and axially keyed to a needle shield assembly, which is removable for embodiments where the injectable medication is administered over multiple days / multiple injection sites and through multiple needles.

[0029] The needle shield subassembly is provided to be sterile or sterilized before being attached to the automatic injection device. Sterility is only compromised after the cap is removed.

[0030] The automatic injection device features disclosed herein may be applicable to both automatic injection devices powered by a spring (compression or constant force) and automatic injection devices powered by compressed gas. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] It is believed that the present disclosure will be more fully understood from the following description in conjunction with the accompanying drawings. Some drawings may be simplified by omitting selected elements for the purpose of more clearly illustrating other elements. Such omission of elements in some drawings does not necessarily indicate the presence or absence of a particular element in any exemplary embodiment, unless otherwise expressly stated in the corresponding written description. The drawings are not necessarily drawn to scale.

[0032] Figure 1 A series of schematic side views of the automatic injection device disclosed herein are shown, illustrating the deployment and retraction of the needle shield during administration of an injectable drug through the automatic injection device. Various stages of operation are provided, labeled (1) shipping; (2) barrel pierced; (3) start of administration; (4) end of administration; and (5) end of procedure. A view of the needle shield with the injection needle removed is also provided.

[0033] Figure 2 Shown are the cap and housing of the automatic injection device disclosed herein and the components within the automatic injection device when the cap and housing are removed.

[0034] Figure 3 A series of schematic side views of the automatic injection device disclosed herein are shown, illustrating the interaction of the components of the needle shield, needle holder pin, barrel, needle holder, and spring during administration of an injectable drug through the automatic injection device. Various stages of operation are provided, labeled (1) shipping; (2) barrel pierced; (3) start of administration; (4) end of administration; and (5) end of procedure. A view of the needle shield with the injection needle removed is also provided.

[0035] Figure 4 A series of schematic side views of the automatic injection device disclosed herein are shown, illustrating the interaction of the components of the needle shield, needle tray, and slider during administration of an injectable drug through the automatic injection device. Various stages of operation are provided, labeled (1) shipping; (2) barrel pierced; (3) start of administration; (4) end of administration; and (5) end of procedure. A view of the needle shield with the injection needle removed is also provided.

[0036] Figure 5 A series of schematic side views of the automatic injection device disclosed herein are shown, and illustrate an exemplary mechanism for pausing a spring-powered injection during administration of an injectable drug by the automatic injection device, the mechanism including the interaction of components of an indicator, a ratchet, a wire, a spring, and a plunger rod. Various stages of operation are provided, labeled (1) shipping; (2) barrel pierced; (3) start of administration; (4) partial administration; (5) pause of administration; (6) resumption of administration; (7) end of administration; and (8) end of procedure.

[0037] Figure 6 is an exploded isometric view of the automatic injection device disclosed herein, the components of which are cross-referenced by numerals as further described below.

[0038] Figure 7 Depicted are various views of a puller component of the automatic injection device disclosed herein.

[0039] Figure 8 Depicted are various views of the safety features of the automatic injection devices disclosed herein.

[0040] Figure 9 Depicted are various views of the locking sleeve components of the automatic injection device disclosed herein.

[0041] Figure 10 Depicted are various views of a needle tray component of the automatic injection device disclosed herein.

[0042] Figure 11 Depicted are various views of a driven component of the automatic injection device disclosed herein.

[0043] Figure 12 Depicted are various views of a cam component of the automatic injection device disclosed herein.

[0044] Figure 13 Depicted are various views of the indicator components of the automatic injection devices disclosed herein.

[0045] Figure 14 Depicted are various views of a plunger component of the automatic injection device disclosed herein.

[0046] Figure 15 Depicted are various views of a support component of the automatic injection device disclosed herein.

[0047] Figure 16 Depicted are various views of the front housing component of the automatic injection device disclosed herein.

[0048] Figure 17 Depicted are isometric exterior views of syringe assemblies and subassemblies of the automatic injection devices disclosed herein.

[0049] Figure 18 A cross-sectional view of the automatic injection device disclosed herein is depicted to reveal internal components.

[0050] Figure 19 Depicts a series of external front views of the automatic injection device disclosed herein, showing an injection pause TM Features and usage phases.

[0051] Figure 20 Depicts a series of internal side views of the automatic injection device disclosed herein having a plurality of internal side views of the automatic injection device ... TM Characteristics of selected internal components related to gas flow and sealing.

[0052] Figure 21 Depicts a series of internal side views of an automatic injection device disclosed herein having an injection pause TM Features and selected internal parts related to the line path of the usage phase.

[0053] Figure 22 Depicts the period of use with pauses in injection TM The cam actuation of the features is related to the independent components of the automatic injection device disclosed herein.

[0054] Figure 23 Depicts a series of interior front views of an automatic injection device disclosed herein having an injection pause TM Features and selected internal parts related to locking during the usage phase.

[0055] Figure 24A series of front exterior views depicting the syringe assembly steps.

[0056] Figure 25 Depicted are the individual components of the automatic injection device disclosed herein, including a rotary lock for syringe assembly.

[0057] Figure 26 Depicted are the individual components of the automatic injection device disclosed herein, including a rotary lock for syringe assembly.

[0058] Figure 27 Depicted are the individual components of the automatic injection device disclosed herein, showing the safety device and needle disk connection during assembly of the syringe.

[0059] Figure 28 A series of front views depicting medication being loaded into the automatic injection device disclosed herein.

[0060] Figure 29 A series of front views depicting a drug being loaded into the automatic injection device disclosed herein, with the connector deployed and bypassing the plunger stop.

[0061] Detailed Description of Exemplary Embodiments

[0062] The present disclosure generally relates to injectable drug delivery devices and corresponding methods and manufacture. More specifically, the present disclosure relates to injectable drug delivery devices configured to allow a user to self-administer a medicament at multiple (one or more) injection stages and / or sites.

[0063] The embodiments disclosed herein are automatic injection devices. Typically, automatic injection devices inject drugs by applying a driving force to a movable part in a drug container such as a syringe or a cartridge. The force in most disposable automatic injection devices is provided by the decompression of a spring (compression or constant force) or the decompression of a compressed gas. The application of the driving force and therefore the injection can be triggered by pressing a needle shield or by an actuating button or switch. Once triggered, the driving force is applied and the drug is automatically injected. In order to pause the injection at any time before the full dose is delivered, the device must offset the driving force with an opposing force, or stop applying the driving force.

[0064] In a spring-based automatic injection device, after the spring is released from its compressed state, it will continue to exert a driving force as it decompresses until the injection is complete. Therefore, pausing an injection using a spring-based automatic injection device requires the application of a counteracting force. This counteracting force may include, but is not limited to, a physical stop, friction, or hydraulic pressure.

[0065] Embodiments of physical stops may involve complementary features of a linear pattern placed on the drive component or the anchoring component such that interlocking occurs between the complementary features on each component. When interlocked, the anchoring component will support the drive component / offset the driving force of the drive component and thereby pause the injection. One such embodiment is disclosed in the original complete application. Similar to a ratchet mechanism, the features of the linear pattern are indicated to allow the injection to be paused at any point during the injection. The components can be actuated between an interlocked state and an unlocked state to pause and resume the injection, respectively. This can be achieved by relative axial translation or rotation between the drive component and the anchoring component. The drive component can be advanced axially while the anchoring component can be brought into an interlocked position rotationally, radially or axially, thereby bringing the drive component to a sudden stop. The anchoring component can then return to its previous position or another position to resume the movement of the drive component.

[0066] Another embodiment of a physical stop could involve a driver component, or a component coupled thereto, being axially stationary and rotating rather than traveling axially. The rotating component would now involve a circular pattern of features or cavities that interlock with complementary features on the anchor component. Locking and unlocking could again be achieved by translation or rotation of the anchor component relative to the driver / driven component.

[0067] The function of automatic injection device embodiments that rely on friction to pause the injection is similar to that of embodiments using physical stops. The anchoring component will be translated or rotated into the appropriate position to interact with the drive component. However, there is a difference in the way the components are docked. Physical stops rely on blocking the path of the moving component, while friction stops may rely on jamming or clamping the moving component to prevent movement so that the driving force (or injection force) is always less than the friction braking force. Embodiments may involve an anchoring component constructed of a high-friction material that presses against the driving / driven component with force, similar to a brake. The resulting friction force will equal or exceed the driving force and stop the moving component and the injection. The anchoring component can then be removed to remove the friction braking component and thus allow free movement of the drive component to resume injection. Friction embodiments can also rely on force amplification or mechanical advantage to achieve the necessary braking force.

[0068] Automatic injection device embodiments with a pause feature implemented using hydraulic pressure are also possible. One such embodiment may feature a cylindrical chamber filled with a plunger at one end and a valve at the other. The chamber will also be filled with an incompressible fluid. The plunger in the cylindrical chamber will be driven by the movement of the injection drive component. If the plunger advances while the valve is open, fluid will flow out of the chamber to another area, allowing the injection to occur. When the valve is closed, the incompressible fluid will be trapped and the movement of the plunger will stop, thereby pausing the injection. Actuation of the valve will allow for controlled starting and stopping of the injection.

[0069] Embodiments of automatic injection devices with a pause feature can be implemented using compressed gas based automatic injection devices. In this regard, pause embodiments of compressed gas based automatic injection devices can also be implemented by removing or dissipating the driving force without the need to counteract the applied force. Methods for removing the driving force include, but are not limited to, disconnecting and resealing the compressed gas source, and diverting the compressed gas source. Embodiments of disconnecting and resealing the compressed gas source can rely on valves or self-repairing / self-sealing diaphragms, as disclosed herein, to provide an injection pause. TM feature.

[0070] To initiate an injection, such an embodiment would involve opening a valve or penetrating a self-sealing septum surrounding a penetrating component with a docking component to allow compressed gas to flow to provide the driving force. To pause the injection, docking the component with a source would disconnect the compressed gas source. The valve would close, or the septum would reseal, to contain the remaining compressed gas. Simultaneously, the now-unconnected docking component would dissipate the previous pressurization that provided the driving force, thereby pausing the injection in the absence of the driving force. To resume the injection, the docking component is reconnected to the source.

[0071] An alternative embodiment for dissipating the compressed gas source to achieve an injection pause can use a three-way valve that can be switched between connecting the drive component to the atmosphere or to the compressed gas source. Before the injection begins, the valve will be set to connect the drive component to the atmosphere. In this state, the compressed gas source is disconnected and does not provide driving force. Then, the actuator will switch the valve to connect the drive component to the compressed gas source to start the injection. Compressed gas will flow to provide driving force. To pause the injection, the valve can be switched back, blocking the compressed gas source again while allowing the pressure that powers the drive component to be discharged and thus dissipating the gas providing the driving force.

[0072] For all of the embodiments described, actuation of an injection pause can be configured to occur passively (no additional, coordinated user step), actively (requiring a coordinated action by the user), or semi-actively.

[0073] A passive injection pause will occur any time the trigger for the injection is released. This embodiment of the automatic injection device is triggered by depressing its needle shield or by holding down an additional button, meaning that if either button is released, the injection is paused. The injection is paused when there is no external force from the user acting on the automatic injection device.

[0074] Active injection pause instead requires an external force from the user to act on the automatic injection device to pause the injection. In this embodiment, the initial trigger for injection and the trigger for pause are separate. In order to pause the injection after the injection is triggered, a separate button or switch must be actively actuated.

[0075] Semi-active injection pause embodiments similarly separate the pause trigger and the injection trigger. The device passively pauses, but requires the user to actuate a button or press a switch to resume injection.

[0076] In each embodiment, the needle safety mechanism is coupled to a mechanism that provides a driving force. The needle safety mechanism is activated only when the mechanism that provides the driving force, or another mechanism connected / coupled thereto, indicates that the dose is complete (or nearly complete). Upon completion of dose delivery, the needle safety mechanism can lock the automatic injection device.

[0077] Most of the currently used single-shot automatic injection devices only provide a qualitative visual indication of the use status of the device (if any), i.e., a visual indication that an injection is occurring, and in some cases, a visual indication that the injection is completed. In some cases, these visual indicators are also difficult to see because they involve observing the syringe / barrel through the incision in the automatic injection device. It would be beneficial if a visual indicator were easier to see and also included quantitative information about the progress of dose delivery (e.g., percentage or volume of completed or remaining injection). Quantitative measurement is particularly helpful for longer injection times. This quantitative visual indicator would be a supplement to the already available qualitative indicator that tracks the dose delivery amount by observing the drug container (syringe or barrel). Features designed for the start and completion of dose delivery with sound prompts are provided.

[0078] The present disclosure describes an embodiment of an automatic injection device, which includes: a syringe including a barrel, a syringe needle fluidly coupled to an interior of the barrel, and a plunger stop configured to translate within the barrel, the plunger stop radially disposed within the barrel, the plunger stop dividing the interior of the barrel into a medicament space configured to contain an injectable medicament between the plunger stop and the syringe needle; a slider coaxially disposed relative to the syringe, the slider rotatably disposed relative to the syringe and substantially axially fixed relative to the syringe; a member axially adjacent to the plunger stop, the axial position of the member being synchronized with the axial position of the plunger stop within the barrel; and a needle safety shield slidably disposed relative to the syringe and the slider, whereby an axial force applied to the needle safety shield causes the needle safety shield to slide relative to the syringe from a guard position, in which the syringe needle is not axially exposed, to an injection position, to actuate the force applied to the plunger stop. wherein movement of the needle safety shield is at least partially guided by an arrangement of a pin and a track, one of the pin and the track being formed with the needle safety shield and the other of the pin and the track being formed with the slider, whereby movement of the pin within the track controls the position of the needle safety shield relative to the slider, the track including a point of no return, the pin being disposed in the track proximal to the point of no return such that the needle safety shield remains axially movable to an injection position, the pin returning the needle safety shield to a guard position when an axial force is removed, the applied force being removed in the injection position, and the pin being disposed in the track distal to the point of no return as the slider rotates such that the pin moves and locks the needle safety shield in the guard position when the axial force is removed; and wherein rotation of the slider is actuated by movement of a member that moves synchronously with the plunger stop, the member rotating the slider to position the safety shield pin to be guided along the track including the point of no return to axially lock the needle safety shield in the guard position when the plunger stop reaches the end of all dose delivery. This embodiment may also optionally include a status indicator that qualitatively and quantitatively indicates the progress of delivery of the injectable drug from the syringe, a status indicator that includes a dose indicator, and / or a dose indicator slidably disposed within a dose indicator window, with the dose indicator being tethered to a member axially adjacent to the plunger stop and moving synchronously with the plunger stop, such that the position of the dose indicator relative to the dose indicator window indicates the axial position of the plunger stop relative to the syringe. In this embodiment, the applied injection force may be offset or dissipated when the pin remains guided to its initially set position or disconnected (which may include offsetting or dissipating).

[0079] The present disclosure describes a method for administering a divided dose by an automatic injection device, comprising the steps of: retracting a needle safety shield from a non-use state to actuate the automatic injection device; applying a force to cause a member to move synchronously with a plunger stop configured to translate within a syringe or barrel; interrupting operation of the automatic injection device by removing the force applied to the plunger stop, translating the needle shield pin along the original track of the slider to its non-use state, and removing the applied force; resuming operation of the automatic injection device by reapplying a force on the plunger stop, wherein the force is actuated by retraction of the needle safety shield; and completing operation of the automatic injection device by removing the force applied to the translation of the plunger stop when the slider is oriented to guide the radial pin of the needle safety shield to a point of no return that locks the needle safety shield. This embodiment may also optionally include a status indicator that qualitatively and quantitatively indicates the progress of delivery of the injectable drug from the syringe, a status indicator that includes a dose indicator, and / or a dose indicator slidably disposed within a dose indicator window, with the dose indicator being tethered to a member axially adjacent to the plunger stop and moving synchronously with the plunger stop, such that the position of the dose indicator relative to the dose indicator window indicates the axial position of the plunger stop relative to the syringe.

[0080] The present disclosure describes another embodiment of an automatic injection device, which includes an automatic injection device, the automatic injection device comprising: a barrel, the barrel including a barrel body, a plunger stopper configured to translate within the barrel body, the plunger stopper being radially disposed within the barrel body, the plunger stopper dividing the interior of the barrel body into a drug space, the drug space being configured to contain an injectable drug between the plunger stopper and the barrel crimping stopper; a slider coaxially disposed with the barrel, the slider being rotatably disposed relative to the barrel and substantially axially fixed relative to the barrel; a member axially adjacent to the plunger stopper a needle safety shield slidably disposed relative to the barrel and the slider, whereby an axial force applied to the needle safety shield causes the needle safety shield to slide relative to the barrel from a guard position in which an injection needle axially keyed to the needle safety shield is not axially exposed to an injection site in the injection position, wherein the movement of the needle safety shield is at least partially guided by an arrangement of pins and tracks, one of the pins and tracks being formed with the needle safety shield and the other of the pins and tracks being formed with the slider, whereby movement of the pin within the track controls the position of the needle safety shield relative to the slider, the track including a point of no return, wherein when the pin is disposed in the track proximal to the point of no return, the pin allows the needle safety shield to remain axially movable to the injection position, and when the axial force is removed, the pin returns the needle safety shield to the guard position, and when the pin is disposed in the track distal to the point of no return as the slider rotates, the pin moves and locks the needle safety shield in the guard position when the axial force is removed; wherein the slider The invention relates to a device for injecting a needle into a syringe pump, wherein the needle safety shield is axially locked in a guard position when the plunger stop reaches the end of all dose delivery; wherein, when the pin travels from the injection position to the guard position, the force applied to the plunger stop is offset by a component introduced into the path of a component coupled to the member; and wherein the needle safety shield with the interlocked injection needle is removable after the safety shield pin reaches the point of no return. In this embodiment, a portion of the member may also be optionally radially disposed within the barrel and sealed against the barrel. This embodiment may further include a reservoir containing a disinfectant, the reservoir disposed between the injection needle and the non-medicated side of the barrel crimp stop, and configured such that when the needle safety shield moves from the guard position to the injection position, the injection needle passes through the reservoir before piercing the barrel crimp stop to fluidically couple to the interior of the barrel.This embodiment may also optionally include a status indicator that qualitatively and quantitatively indicates the progress of delivery of the injectable drug from the syringe, a status indicator that includes a dose indicator, and / or a dose indicator slidably disposed within a dose indicator window, with the dose indicator being tethered to a member axially adjacent to the plunger stop and moving synchronously with the plunger stop, such that the position of the dose indicator relative to the dose indicator window indicates the axial position of the plunger stop relative to the syringe.

[0081] The present disclosure describes a sterile automatic injection device embodiment that includes a pre-installed sterile container operably coupled to a fluid port via a connector, wherein the connector bypasses a plunger stop radially disposed within and sealed against the container, the container being positioned to deliver a predetermined injection volume; wherein the connector and the fluid port are configured to be removed once the container is filled to the predetermined injection volume; and wherein the plunger stop is configured to radially seal once the connector is disconnected from the container. In this embodiment, the connector may also optionally be a hollow tube, the sterile container may also optionally be a barrel, the fluid port may also optionally be a female Luer connector, and / or all other components involved in normal automatic injection device operation may also optionally be in a ready-to-use state prior to filling the container with an injectable fluid.

[0082] Various embodiments of the automatic injection device disclosed herein may include one or more of the following components identified by numbers in the specification, claims, and drawings: (1) device; (2) needle shield; (2-1) needle shield rail; (2-2) needle shield beam; (2-3) needle shield arm; (2-4) needle shield pin; (3) drug; (4) barrel; (5) needle holder; (5-1) needle holder needle; (5-2) needle holder pin; (6) injection needle; (7) housing; (8) cover; (9) canister; (9-1) canister septum; (10) window; (11) plunger stop; ( 12) needle guard spring; (13) slider; (13-1) slider track; (13-2) slider keyway; (13-3) slider beam; (14) needle plate; (14-1) needle plate needle; (14-2) needle plate key; (15) needle plate spring; (16) device; (17) indicator; (17-1) indicator beam; (18) wire; (19) drive spring; (20) plunger rod; (21) ratchet; (21-1) ratchet ramp; (21-2) ratchet teeth; (22) needle guard; (22-1) needle guard arm; (23) device; (24) syringe; ( 24-1) syringe shoulder; (25) needle cover; (26) rigid needle shield; (27) cap; (28) puller; (28-1) barb; (29) safety device; (29-1) safety device arm; (29-2) safety device stop; (29-3) safety device hook; (30) spring; (31) locking sleeve; (31-1) locking beam; (31-2) L-shaped beam; (32) needle disk; (32-1) air needle; (32-2) needle disk flange; (33) syringe seal; (34) follower; (35) cam; (35-1) cam stop; (35-2) cam ramp; (36) stopper; (37) rear cover; (37-1) track; (38) indicator cover; (38-1) indicator cover marking; (39) end cap; (40) rear housing; (41) bracket; (41-1) bracket lip; (41-2) L-shaped groove; (42) front housing; (42-1) front housing lip; (42-2) housing window; (43) window sleeve; (44) X-ring; (45) O-ring; (46) sealing insert; (47) vial; (48) filling syringe; (49) transfer needle; and (50) filling cannula. The corresponding numerical designations are intended as illustrative guides to facilitate general cross-referencing of components only and are not intended to be limiting. In practice, components and their numerical designations may represent structural and / or functional elements that may be difficult to distinguish or overlap, for example, representing a collection of components or a component of another component.

[0083] Figure 1 An automatic injection device is depicted in which the device (1) is received and uncapped to reveal the device in a shipping state (not shown) without a cap (not shown) Figure 1A) of the needle shield (2) or needle safety shield. The user then fully depresses the needle shield (2) axially in one continuous motion ( Figure 1 B). When the needle shield (2) is depressed, the barrel (4) (not shown) filled with the drug (3) (not shown) is first pierced by the non-patient end (not shown) of the injection needle (6), and then the patient end of the injection needle (6) is inserted into the injection site. The drug (3) (not shown) is then injected ( Figure 1 C). Once the injection is complete, the device (1) is removed from the injection site and the needle shield (2) is extended and locked after extending beyond the tip of the injection needle (6) and preventing further use ( Figure 1 D). In the case of a multiple use automatic injection device embodiment, the entire needle shield (2) containing the injection needle (6) can then be removed from the device (1) and discarded ( Figure 1 E).

[0084] Figure 2 An automatic injection device is depicted in FIG, wherein the automatic injection device has a housing (7) and a cover (8), the cover (8) featuring a window (10) for inspection of the drug (3) while containing internal components. Figure 2 In B the cover (8) is removed and Figure 2 In C both the cover (8) and housing (7) have been removed to show the compressed gas source (9), needle disc (14) and slide (13).

[0085] Figure 3 The individual components of an automatic injection device are depicted in the figure, with corresponding cross-sectional views, showing how the needle shield (2) and the needle holder (5) interact to pierce the barrel (4) filled with the drug (3) and insert the injection needle (6) when the needle shield (2) is depressed in one movement. Paired side views and cross-sectional views are shown throughout the steps of use. The needle holder (5) contains a double-sided needle (5-1), i.e. a non-patient side for piercing the barrel septum (4-1) and a patient side for injection. A reservoir (5-3) for containing a sterilizing fluid (not shown) is also provided within the needle holder, the reservoir (5-3) being enclosed by a membrane (not shown) adjacent to the barrel septum (4-1). When the cap is removed, the membrane is removed, thereby exposing the sterilizing fluid to contact the barrel septum (4-1). The needle holder (5) also features two radially guided pins (5-2), which are housed in tracks (2-1) on the needle shield (2); thus, the two components are axially keyed. The injection procedure starts with the device (1) in the shipping (before use) position ( Figure 3 A) Start. When the needle shield (2) is depressed to start the injection ( Figure 3B), the needle shield beam (2-2) initially prevents the needle holder pin (5-2) from moving freely in the track (2-1). The beam (2-2) is configured so that the force for the pin (5-2) to deflect the beam (2-2) and move past the beam (2-2) is higher than the force for the needle (5-1) of the needle holder (5) to penetrate the barrel septum (4-1). This results in no relative movement between the needle shield (2) and the needle holder (5) until the barrel septum (4-1) is fully penetrated. Once the barrel septum (4-1) is fully penetrated, the needle holder (5) will rest against the front of the barrel (4), forcing the pin (5-2) to now deflect the beam (2-2) and reach the bottom of the track (2-1) ( Figure 3 C). This relative movement of the needle holder (5) with respect to the needle shield (2) inserts the injection needle (6) into the injection site. Once the injection is complete and the device (1) is removed ( Figure 3 D), the spring (12) is decompressed and the pin (5-2) moves upward along the track (2-1) enough to allow the injection needle (6) to be covered by the needle shield (2). The needle shield (2) and the needle holder (5) can then be removed from the device (1) as a whole.

[0086] Figure 4 An automatic injection device is depicted in Figure 1, which illustrates how the needle shield (2), slider (13) and needle disk (14) interact to lock the automatic injection device device (1) at the end of dose delivery and allow removal of the needle shield (2) containing the needle (6). Front views of the internal components are shown throughout the steps of use. Below each front view is a paired side view of an independent slider (13), which depicts the position of the needle shield pin (2-4) in the slider track (13-1). The needle shield (2) interacts with the needle disk (14) via two arms (2-3), which extend to push the needle disk (14) when the needle shield (2) is depressed. Both needle shield arms (2-3) also feature a pin (2-4) that fits into the slider track (13-1) to control the rotational position of the slider (13). In addition, the rotational position of the slide (13) is controlled by the dial key (14-2) which cooperates with the slide keyway (13-2). The slide (13) can only rotate around the barrel (4) and is axially fixed. Both the needle shield (2) and the needle disc (14) are rotationally fixed but can translate axially. The injection procedure starts from the time the device (1) is in the shipping state ( Figure 4 A) Start. When the needle shield (2) is depressed to perform the injection ( Figure 4B), the needle shield pin (2-4) moves upward in the slider track (13-1). The needle dial key (14-2) also completely leaves the slider keyway (13-2) when it approaches the canister (9). When the needle shield (2) has been fully depressed, the pin (2-4) will reach the top of the track (13-1) and force the slider (13) to rotate due to the inclined geometry of the slider (13), such as the dosing start position ( Figure 4 Once the injection is complete ( Figure 4 D), and as the device (1) is removed from the injection site ( Figure 4 E), the needle disc spring (15) and needle shield spring (12) are decompressed, and the needle shield (2) extends outwards. Because the slider (13) has been rotated, when the needle shield (2) extends outwards, the pin (2-4) now travels downwards along a different path than it started from. In this path, the pin (2-4) is pushed past the slider beam (13-3), which deflects away before returning and blocking the path for the pin (2-4) to return. This blocking prevents the needle shield (2) from being depressed again and locks the injection needle (6) from further use at the end of dose delivery. In addition, the end of the track (13-1) opens past the beam (13-3), which allows the user to completely remove the needle shield (2) and the contained needle (6) from the device (1). Figure 4 F. Figure 4 G). Sliding member (13) is in the program end position ( Figure 4 The rotational position at E) also prevents the needle disc (14) from returning to its original position because the key (14-2) now does not fit into the keyway (13-2). Instead, the key (14-2) pushes against the keyway (13-2). The angled edges of the key (14-2) and keyway (13-2) would cause the slide (13) to rotate back to its shipping position, but the pin (2-4) in the track (13-1) prevents this. Only when the needle shield (2) is completely removed can the needle disc (14) rotate the slide (13) back to its shipping position, while also returning to its own shipping position ( Figure 4 F. Figure 4 G).

[0087] Figure 5 An automatic injection device is depicted in FIG, showing a mechanism for pausing a spring-powered injection. The mechanism consists of an indicator (17) and a wire (18) which tethers the indicator (17) to a plunger rod (20) driven by a spring (19). There is a ratchet (21) actuated by a needle shield arm (22-1) to allow the indicator (17) to travel freely or to hold it in place. The device (16) is received in the shipping position ( Figure 5 A). When the needle shield (22) is fully actuated, the first injection begins, such as in the dosing start position ( Figure 5C). This triggers the initial release of the spring (19) to drive the plunger rod (20), while also moving the ratchet (21) out of the path of travel of the indicator (17) as the needle shield arm (22-1) pushes on the ratchet ramp (21-1). To pause the injection at any point, the device can be lifted from the injection site, causing the needle shield (22) to re-extend ( Figure 5 E). When this happens, the needle guard arm (22-1) retracts from the ramp (21-1), causing the ratchet (21) to move to block the path of the indicator (17) and the indicator (17) to be inserted against one of the teeth (21-2) of the ratchet. Since the indicator (17) is now unable to move, the wire (18) is tightened and prevents further decompression of the spring (19), so that the plunger rod (20) stops administering the drug. The device (1) remains in the paused position until the needle guard (22) is fully actuated again and the ratchet (21) is cleared from the path of the indicator (17), allowing the injection to be resumed ( Figure 5 F). The device (16) can be paused multiple times during and at any point during the injection. Only when the device (16) has reached the end of administration position ( Figure 5 G) and the device (16) is removed to end the procedure ( Figure 5 H), the needle shield (22) is locked to prevent further use.

[0088] Figure 5 An alternative embodiment of the mechanism depicted in the embodiment of the present invention may instead lock the rotation of the pulley (18-1) via the needle shield arm (22) without having a ratchet (21) component. This would achieve an effect equivalent to blocking the travel of the indicator (17). A wireless embodiment may also be made in which the ratchet (21) directly interfaces with a feature on the plunger rod (20) to block its movement. In another alternative embodiment, the pulley (18-1) is replaced by an alternative mechanism arranged coaxially with the hollow plunger rod (20).

[0089] The device (23) illustrates an embodiment having a modular architecture that is designed to allow a syringe to be easily assembled into an assembled automatic injection device. The modular architecture consists of a top subassembly and a bottom subassembly that can be separated by first rotating them relative to each other and then pulling them apart. The syringe can then be placed into the lower assembly and the top assembly can be pushed back and then rotated to lock the subassemblies together. Assembling the syringe into the automatic injection device can now occur as the last step in the assembly process. This will allow the syringe assembly to be easily produced at a different manufacturing location from the rest of the device (23) assembly.

[0090] Device (23) also illustrates an embodiment of an automatic injection device with dose-dependent locking. This allows the automatic injection device to utilize the ability to pause the injection while still locking when the injection is completed. Compared to the previously described embodiments, this embodiment also allows for larger viewing windows for both the syringe and the auxiliary dose progress indicator, and locks the device with a stronger lock. The biasing element between the compressed gas source and the penetrating component has also been removed without loss of function.

[0091] Figure 6 An automatic injection device is depicted in which a device (23) houses a syringe (24) containing an injectable drug (3) and having a needle (6) for delivering the drug (3). The needle (6) is encapsulated by a resilient needle cover (25), which in turn is encased by a rigid needle shield (26) that seals and covers the end of the needle (6) of the syringe (24). The device (23) has an outer cap (27) that the user removes before injection. Removal of the cap (27) also results in removal of the needle cover (25) and the rigid needle shield (26) via a puller (28) to expose the injection needle (6). The puller (28) ( Figure 7 ) has barbs (28-1) oriented to allow axial locking between the rigid needle shield (26) and the puller (28) during assembly.

[0092] Removing the cap (27) also exposes the safety device (29). The safety device (29) acts as a trigger to activate the injection. When the safety device (29) is pressed axially against the injection site, the injection begins. When lifted from the injection site, the safety device (29) is re-extended via the spring (30) and the injection stops. If it is lifted before all the medicine (3) has been delivered, the safety device (29) returns to its initial position and can be re-pressed to resume the injection. If it is lifted after all the medicine (3) has been delivered, the safety device (29) extends beyond its initial position and locks to protect the needle (6). When locked, the axial position of the safety device (29) is further away from the tip of the needle (6) than the axial position before the injection started (initial position).

[0093] Safety device (29)( Figure 8 Each arm (29-1) features a stop (29-2) that engages a locking sleeve (31) ( Figure 9 ) interacts with the beams (31-1) on the safety device (29) to lock its position. Before locking, the beams (31-1) are stuffed inside the stoppers (29-2) and allow free axial movement of the safety device (29). However, when the safety device (29) extends beyond its initial position, a point of no return is reached, and the beams (31-1) can expand radially outward and contact the stoppers (29-2) so that the safety device (29) cannot be pressed axially again.

[0094] The safety device (29) is activated by axially actuating the needle disc (32) ( Figure 10 ) to control the injection. The safety device (29) features a hook (29-3) at the end of each arm (29-1) that fits onto a flange (32-2) of the needle disk (32) during assembly. Axial movement of the safety device (29) is directly converted into axial movement of the needle disk (32). When pressed, the safety device (29) causes the needle disk (32) to slide toward the tank (9) containing compressed gas. The air needle (32-1) of the needle disk (32) penetrates the diaphragm (9-1) of the tank (9) and the compressed gas flows through the air needle (32-1) into the syringe seal (33) and the follower (34) ( Figure 11 ) between the piston and the piston. Pressure pushes the follower (34) against the plunger stop (11) and delivers the drug (3). When the safety device (29) is re-extended, the needle disk (32) slides away from the tank (9) and the air needle (32-1) is removed from the diaphragm (9-1), which reseals. The now exposed end of the air needle (32-1) simultaneously expels the pressure pushing the follower (34) and the injection stops. If the drug (3) remains in the syringe (24), the safety device (29) that has not yet been locked can be re-pressed to re-activate the release of compressed gas and resume injection. If all the drug (3) has been delivered, the safety device (29) locks and the needle disk (32) can no longer be actuated.

[0095] The extended position of the safety device (29) is controlled by the needle plate (32) and the cam (35) ( Figure 12 ) is controlled by the interaction between the cam (35) and the needle disk (32). The flange (32-2) of the needle disk (32) initially rests on the two stops (35-1) of the cam (35). The stops (35-1) prevent the needle disk (32) and the safety device (29) from extending further outward. The needle disk (32) can only travel between the stops (35-1) and the canister (9) until all the medication (3) has been delivered and the cam (35) is rotated to the locked position. In the locked position, the stops (35-1) of the cam (35) are rotated out of the path of the needle disk (32) and it can extend outward beyond its starting position, thereby allowing the safety device (29) to extend outward to its locked position. This interaction between the cam (35) and the needle disk (32) that controls the extended position of the safety device acts as the pin and track from the previously described embodiment. Here the flange (32-3) acts as the pin, the cam (35) and stop (35-1) act as the track, but now the point of no return is achieved by the safety stop (29-2) and locking beam (31-1).

[0096] The rotation of the cam (35) is indicated by the indicator (17) ( Figure 13) is triggered, the indicator (17) is tethered to the plug (36) which fits in the follower (34) ( Figure 14 ). In this embodiment, the tether is via a thin wire (18) that can pass through the syringe seal (33). As the follower (34) advances in the syringe (24), the indicator (17) also advances. Near the end of the injection, the indicator (17) reaches the inclined surface (35-2) on the cam (35) and pushes against the inclined surface (35-2) to drive the rotation.

[0097] The indicator (17) travels axially in a track (37-1) on the back cover (37) during injection. The indicator cover (38) physically shields the indicator (17) from the user at all times. However, the indicator (17) can be seen translating under the partially transparent indicator cover (17) and visually aligned with its marking (38-1) to provide visual feedback of the injection progress. The indicator (17) also has a flexible beam (17-1) that is actuated when it is moved by features on the back cover (37) or indicator cover (38) to provide an audible click heard by the user, which signals the start and end of the injection.

[0098] The rear cover (37) is assembled with the end cover (39) to enclose the indicator (17) and the indicator cover (38). The rear housing (40) is also assembled with the rear cover (37) and the end cover (39) to enclose the tank (9), the cam (35), the needle plate (32) and the bracket (41). Alternative embodiments may feature the rear housing (40), the rear cover (37) and the bracket (41) as one component. The bracket (41) ( Figure 15 ) features a lip (41-1) that hooks to the front housing (42) ( Figure 16 ) on the lip (42-1) to connect the front and rear parts of the device (23) ( Figure 17 ).

[0099] Within the front housing (42), the syringe (24) is supported at its shoulder (24-1) during injection by a transparent window sleeve (43). A flexible X-ring (44) also acts as a gasket between the window sleeve (43) and the syringe (24). Both the window sleeve (43) and the locking sleeve (31) are rotatably and axially fixed in the front housing (42), shown here as two halves. An alternative embodiment may include the front housing (42) as an integral component. An alternative embodiment may also include the locking sleeve (31) and the window sleeve (43) as a single component.

[0100] The front housing (42) also has a window opening (42-2) that allows a user to view the syringe (24) and plunger stopper (11) through a transparent window sleeve (43).

[0101] The bracket (41) has an L-shaped slot (41-2) that interacts with the L-shaped beam (31-2) of the locking sleeve (31) to rotatably secure the front and rear halves of the device (23) together only when a syringe (24) is present.

[0102] Figure 18 An automatic injection device is depicted in , which shows a cross-sectional view of the fully assembled device ( 23 ) in the state in which the user will receive the device ( 23 ). Figure 18 A shows a left side cross-sectional view, and Figure 18 B and Figure 18 C shows a right side cross-sectional view. Figure 18 D shows a left side cross-sectional view, and Figure 18 E and Figure 18 F shows a right side cross-sectional view.

[0103] Figure 19 An automatic injection device is depicted in an external front view showing an injection pause TM Features and usage stages. This embodiment is used when the user receives the device. Figure 19 A shows the device from the front. The plunger stop (11) can be seen through the window (42-2). The indicator (17) can also be seen at the beginning of its track (37-1), which is adjacent to the marking (38-1) indicating the volume of the drug (3) in the device (23). Figure 19 In B, the cap (27) has been removed and the device (23) is ready for use. Figure 19 C shows the device (23) when the safety device (29) is depressed to start the injection. Figure 19 D shows the device (23) during an injection. The plunger stop (11) and indicator (17) can both be seen advanced. The follower (34), O-ring (45), stopper (36) and wire (18) are now also visible in the window (42-2). Figure 19 In E, the device (23) has been raised to pause the injection. The safety device (29) has been re-extended to its initial position, but the indicator (17) and the plunger stop (11) are paused at their respective midpoints. Figure 19 In F, press the safety device (29) again to resume injection until Figure 19 The end of dosing is reached in G. The indicator (17) and the plunger stop (11) have now reached the end of their travel. Figure 19In H, the device (23) is lifted away from the injection site and the safety device (29) is extended further outward than its initial position. The safety device (29) is locked to protect the injection needle (6) and the procedure ends.

[0104] Figure 20 The automatic injection device is depicted, which only includes the gas flow and injection pause TM Components directly related to the sealing of features. Selected stages of use are shown in an internal front view. Figure 20 A shows the ready-to-use state of the automatic injection device. The bilateral needles (32-1) of the needle tray (32) can be seen. The top tip of the needle (32-1) is at a distance from the diaphragm (9-1) of the tank (9). The bottom tip of the needle (32-1) is placed through the sealing insert (46) assembled between the follower (34) and the plug (36). The bottom tip of the needle (32-1) also passes through the syringe seal (33). The needle (32-1) does not leave the syringe seal (33). In this state, the needle (32-1) allows air to flow from just behind the plunger stopper (11) to the atmosphere. This allows the sealed follower (34) to be assembled into the syringe (24) without trapping air.

[0105] exist Figure 20 In B, when the safety device (29) is depressed, the needle disc (32) advances until it abuts the tank (9) and the top tip of the needle (32-1) penetrates the septum (9-1). Immediately thereafter, in the same movement, the bottom tip of the needle (32-1) is removed from the sealing insert (46), which then reseals. This places the bottom tip of the needle (32-1) in the sealing area of ​​the syringe (24), which is defined by the follower (34), the O-ring (45) and the sealing insert (46) at one end and the fixed syringe seal (33) at the other end. Compressed gas flows from the tank (9) through the needle (32-1) and into the sealing area of ​​the syringe (24). As Figure 20 As shown in C, the pressure pushes the follower (34) and the drug (3) is delivered. Figure 20 In D, the automatic injection device has been lifted midway through the injection and the safety device (29) has been re-extended. This re-extension returns the needle disc (32) to its initial position. The top tip of the needle (32-1) is removed from the canister (9), the canister (9) is resealed, and the tip is exposed to the atmosphere again. However, when the follower (34) containing the sealing insert (46) is axially advanced, the bottom tip of the needle (32-1) remains in the pressurized area of ​​the syringe (24). This causes the pressure to be discharged through the needle (32-1) and the injection to be suspended. The user can then resume the injection by depressing the safety device (29) again to re-pressurize the syringe (24).

[0106] Figure 21 An automatic injection device is depicted in FIG, with the injection pause highlighted in an interior side view including only directly relevant components. TM Features and Wire Path for Select Use Phases. Wire (18) is connected to the indicator (17), passes through the syringe seal (33) and connects to the plug (36) which fits in the follower (34). Figure 21 A shows the automatic injection device before injection, Figure 21 B shows the start of the injection, and Figure 21 C shows the device removed and locked after the injection is completed. The progression of the wire (18) pulling the indicator (17) during the injection process is shown. One skilled in the art will appreciate that the wire can be replaced with a smooth cylindrical rod with appropriate modifications using the same concepts disclosed herein.

[0107] Figure 22 The individual components of the automatic injection device are depicted in FIG. The activation of the injection pause is shown. TM The characteristic cam (35) is actuated, wherein the indicator (17) and the needle plate (32) are separated from the rest of the device. Figure 22 In A, the components are in their shipping position. The needle plate (32) is biased against the stop (35-1) of the cam (35) from the safety device (29) (not shown) and the spring (30) (not shown) that extends the safety device (29). Figure 22 In B, the safety device (29) has been depressed and the needle disc (32) has been pushed into the canister (9) to start the injection. The indicator (17) starts to advance, as shown in FIG. Figure 22 As shown in C. Figure 22 In D, the indicator (17) has reached the end of its axial travel and has rotated the cam (35) by pushing against the ramp (35-2). This moves the stop (35-1) of the cam (35) out of the return path of the needle disc (32), which is still in the tank (9). Figure 22 In E, the device (23) has been removed from the injection site and the safety device (29) has been re-extended. As the cam (35) rotates and the stopper (35-1) moves, the needle disc (32) returns to a new position below its initial position. This causes the safety device (29) to extend beyond the point of no return and trigger the lock.

[0108] The point in the injection at which the indicator (17) causes the cam (35) to rotate can be configured to be any point during the injection. A de-featured embodiment without the above capability is also possible by configuring the needle disc (32) or safety device (29) to directly rotate the cam (35) when the device (23) is actuated.

[0109] Figure 23An automatic injection device is depicted in FIG, showing an injection pause in an interior front view. TM A locked independent component of a feature. Figure 23 A shows the state of the device when the safety device (29) is freely depressed, before injection or when injection is paused. In this state, the locking beam (31-1) is bent radially inward and extends beyond the stop (29-2) on each arm (29-1) of the safety device (29). Figure 23 B shows the device (23) during an injection. The safety device (29) is depressed and the locking beam (31-1) still extends beyond the stop (29-2) of the safety device (29). Releasing the safety device (29) before the injection is finished returns the device to Figure 23 The state in A. The safety device (29) is released only at the end of the injection resulting in Figure 23 The locked state is shown in C. Figure 23 In C, the safety device (29) has been extended beyond its initial position, allowing the stops (29-2) to extend beyond the locking beams (31-1) and splay radially outward. If the safety device (29) is pressed in this state, each stop (29-2) will collide with the beams (31-1). In addition, the stops (29-2) and the locking beams (31-1) are angled to prevent slippage when pressed. As a result, the device is fully locked.

[0110] Figure 17 An automatic injection device is depicted in FIG, which shows the syringe assembly and subassemblies in an isometric external view. This embodiment of the device consists of an upper / rear subassembly ( Figure 17 A) and the lower / front subassembly ( Figure 17 B) and then link them together ( Figure 17 C). A bracket (41) extends from the upper subassembly to interface with the lower subassembly, and a safety device (29) extends from the lower subassembly to interface with the upper subassembly.

[0111] Figure 24 An automatic injection device is depicted in FIG, which shows a front view of the step of assembling the syringe (24) into the device (23). Figure 24 A shows the state of the device (23) without receiving the syringe (24). The absence of the syringe (24) can be checked through the window (42-2). When the syringe (24) is not present, the device (23) can be opened by first Figure 23 Rotate the top subassembly as shown in B, then Figure 23 C and separate it into its subassemblies. The syringe (24) can then be slid axially into the bottom subassembly, as shown in FIG. Figure 24 D and Figure 24 E. Then push the subassembly back together ( Figure 24F) and rotate to their initial positions ( Figure 24 G). With the syringe (24) now closed, the subassemblies are rotationally locked together and will no longer separate. The presence of the syringe (24) can be seen in the window.

[0112] The axial connection between the two subassemblies is provided by the lip (41-1) of the bracket (41) abutting against the lip (42-1) in the front housing (42). The rotational locking between the subassemblies is independently provided by the L-shaped beam (31-2) on the locking sleeve (31) abutting against the L-shaped groove (41-2) of the syringe (24) and the bracket (41).

[0113] Figure 25 and Figure 26 The individual components of an automatic injection device are depicted, including a rotary lock for a syringe (24) assembly. Figure 25 Shown is an isolated view of the bracket (41) and locking sleeve (31). The bracket (41) has hidden lines visible. Figure 25 In A, the connected state of the device (23) is shown before the syringe (24) is inserted. The L-shaped beam (31-2) of the locking sleeve (31) is not bent and is located in the L-shaped groove (41-2) of the bracket (41). When the bracket (41) located in the top subassembly is rotated counterclockwise (in Figure 25 When the locking sleeve (31) is rotated (viewed from above in B), the L-shaped beam (31-2) of the locking sleeve (31) bends radially inwards and comes out of the L-shaped slot (41-2). This releases the rotation lock between the subassemblies. Once rotated, the subassemblies can be separated axially ( Figure 25 C).

[0114] Figure 26 An isolated view of the bracket (41), locking sleeve (31) and syringe (24) is shown. Figure 26 In A, the device (23) is shown in its detached state, with the syringe (24) inserted. Figure 26 In B, the two subassemblies are pushed together axially and the L-shaped beam (31-2) is bent downward by the bracket (41). Figure 26 In C, viewed from above, the top subassembly containing the bracket (41) rotates clockwise and the L-shaped beam (31-2) is released into the L-shaped slot (41-2). This completes the assembly of the syringe (24) and the device (23). With the syringe (24) now present, the L-shaped beam (31-2) can no longer be Figure 25 B bends radially inwardly to disengage from the L-shaped slot (41-2), so that the subassembly is rotationally locked.

[0115] The connection of the subassembly causes the L-shaped beam (31-2) to bend downward, while the separation causes the L-shaped beam (31-2) to bend radially inward. This distinction allows connection to occur regardless of the presence of the syringe (24), while separation can only occur in the absence of the syringe (24). To this end, the L-shaped beam (31-2) is L-shaped so that forced rotation in the presence of the syringe (24) causes the L-shaped beam (31-2) to bend upward and hinder rotation, rather than sliding back down the connection path and unlocking. This maintains the distinction between connection and separation.

[0116] Figure 27 The individual components of the automatic injection device are depicted in FIG. The safety device (29) and the needle disk (32) are shown in separated views to highlight how the safety device (29) couples with the needle disk (32) when the top and bottom subassemblies are joined. Figure 27 A shows the safety device (29) and the needle disc (32) when the subassemblies are axially separated. Figure 27 B shows the safety device (29) and the needle disc (32) when the subassembly is pushed axially together. The hook (29-3) on each arm (29-1) of the safety device (29) slides over the flange (32-2) of the needle disc (32). Figure 27 In C, the top subassembly containing the needle disc (32) is then rotated and the flange (32-2) of the needle disc (32) slides into the hook (29-3) of the safety device (29). When actuated, the safety device (29) will now push and pull the needle disc (32) axially. This attachment will be undone when the subassemblies are rotated and separated.

[0117] Figure 28 An automatic injection device is depicted in FIG, which shows a drug (3) being loaded. The drug (3) is contained in a vial (47). The drug (3) is then transferred to a syringe (48). Alternatively, the drug can be placed in a pre-filled syringe. The drug (3) from the syringe (48) is then transferred to the automatic injection device via a removable hollow connector (50). The connector (50) matches the syringe and is typically a female Luer connector or another configuration to achieve the same mechanism. When the drug is transferred from the syringe (48) to the automatic injection device via the connector 50, the automatic injection device is now filled. Once all the drug (3) is transferred to the automatic injection device, the connector (50) is removed while still attached to the syringe (48). The automatic injection device, together with the removable connector (50) incorporated therein, is sterile before filling. The drug (3) filling can be carried out in a laminar flow hood, depending on the storage duration after the drug is transferred to the automatic injection device.

[0118] Figure 29An automatic injection device is depicted in , which shows the drug being loaded in an alternative embodiment. The figure shows how the connector (50) is configured and bypasses the plunger stop (11).

[0119] The automatic injection device disclosed herein includes a compressed gas source incorporated into various embodiments of the automatic injection device. The embodiments disclosed herein are intended to improve upon the shortcomings of other compressed gas automatic injection device technologies and other automatic injection devices. Embodiments of the automatic injection device include features that further enhance usability and address some technological gaps in current automatic injection devices. The novel features disclosed herein can be applied to automatic injection devices that do not have a compressed gas power source.

[0120] The present disclosure describes a compact, high-performance automatic injection device powered by a compressed gas source. The present disclosure also provides a method for manufacturing an automatic injection device having a compressed gas source, the compressed gas source consisting of a container having a closure element that is pierceable but hermetically sealed around a piercing element (such as a sharp, hollow metal tube / needle). When the tube is removed, the pierceable closure element seals again, retaining uncompressed pressurized gas within the compressed gas source.

[0121] According to one aspect of the present disclosure, an automatic injection device for injecting an injectable drug with the assistance of compressed gas is provided. The automatic injection device includes a compressed gas source and a syringe mounted together via a housing. The compressed gas source includes a rigid container defining an interior space and an opening leading to the interior space; and a non-rigid sealing structure configured and arranged to seal the opening leading to the interior space to maintain the compressed gas in a compressed state. The syringe includes a barrel, a syringe needle fluidly coupled to the barrel interior, a plunger stopper configured to translate within the barrel, and a seal configured to seal the barrel relative to the syringe needle. The plunger stopper is radially disposed within the barrel and divides the barrel interior into a drug space and an actuation space. The drug space is configured to contain the injectable drug between the plunger stopper and the syringe needle, and the actuation space is located between the plunger stopper and the seal. The automatic injection device also includes a puncture needle. The puncture needle is axially aligned to selectively penetrate the non-rigid sealing structure of the compressed gas source during relative axial movement between the puncture needle and the compressed gas source, thereby fluidically coupling the puncture needle to the compressed gas source. At least one of the compressed gas source and the introducer needle is movably mounted such that the introducer needle selectively penetrates the non-rigid sealing structure to selectively fluidly couple the compressed gas source with the actuation space.

[0122] According to another aspect of the present disclosure, a compact, sealed source of compressed gas is provided. The compressed gas source includes a rigid container, a non-rigid sealing structure, a crimping sleeve, and a conically shaped rigid structure. The rigid container defines an interior space and includes an enlarged neck portion that defines an opening to the interior space. The non-rigid sealing structure is positioned and configured to seal the opening to the interior space. The non-rigid sealing structure is at least partially disposed within the opening, extending into the opening. The crimping sleeve includes: a generally cylindrical portion disposed about and crimped beneath the enlarged neck portion of the rigid container; and a generally radially extending portion that defines an aperture aligned with the opening to the interior space. The crimping sleeve is configured to prevent the non-rigid sealing structure from moving outward from the enlarged neck portion. The conically shaped rigid structure is configured to apply a sealing force to the non-rigid sealing structure. The conically shaped rigid structure can be formed by the crimping sleeve itself or by a separate structure (e.g., a conical washer). Compressed gas is disposed within the interior space of the rigid container.

[0123] According to another aspect of the present disclosure, a method for manufacturing such a sealed, compact gas source is provided, the method comprising: inserting a non-rigid sealing structure into an opening leading to an interior space of a rigid container, arranging a crimping sleeve around an enlarged neck portion of the rigid container, wherein the conically shaped rigid structure is configured to exert an inwardly directed sealing force on the non-rigid sealing structure, crimping the crimping sleeve around the enlarged neck portion, and filling the rigid container with compressed gas.

[0124] According to another aspect of the present disclosure, a method for administering an injectable drug is provided, wherein the method comprises: fluidly coupling an actuation space of a syringe to a compressed gas source to provide compressed gas, thereby axially translating a plunger stopper in a barrel of the syringe, thereby injecting the injectable drug.

[0125] The components of the automatic injection device for injecting an injectable medication with the assistance of compressed gas as disclosed herein may be modified and adapted to provide a spring-powered automatic injection device.

[0126] Those skilled in the art will appreciate that, based on the teachings of the present disclosure, other arrangements for locking the needle safety shield at the end of an injection may be implemented. For example, a cam-based mechanism may be implemented in conjunction with the concepts disclosed herein.

[0127] Rather than a longitudinally split housing design, the autoinjector device housing may be reconfigured to split transversely to the axis of the device for better manufacturability and better assembly with prefilled syringes.

[0128] It is contemplated that the slider in either embodiment could be positioned coaxially with the syringe, without axial overlap, and still produce the same results as previously described.

[0129] Incorporation of electronic communication components and use of the disclosed invention with electronic methods of data capture, management, and transmission is contemplated as part of this disclosure.Systems including drug delivery devices and methods for using drug delivery systems may involve operating the device in one or more stages or states.

[0130] These states can be determined by using one or more sensors in conjunction with one or more controllers. The sensors can rely on mechanical, electrical, or chemical sensing mechanisms, and the controllers can be mechanical, electrical, or electromechanical. As an example and not limitation, the state can relate to the operation of the drug delivery device or the condition of the drug delivery device. The systems and methods can use the state determination to control the operation of the drug delivery device, and / or the state determination can be transmitted to other devices, such as a third-party server, which can collect, process, and / or further disseminate the state determination received from the system including the drug delivery device, one or more sensors, and one or more controllers. In addition or in an alternative, the systems and methods can transmit the state determination to a local device, such as a mobile computing device (e.g., a cell phone).

[0131] According to the system or method of the present disclosure, one or more states relative to the drug delivery device will be determined. For example, a system or method can determine whether the drug delivery device is in one or more operating states (i.e., a state related to the operation of the drug delivery device delivering the drug to the patient). A non-exhaustive list of general operating states can include (i) packing / preparing for distribution; (ii) packaging / distribution; (iii) unpacking / preparing for administration; (iv) removing the sterile barrier; (v) applying the device; (vi) injecting (or inserting) the cannula; (vii) drug delivery starts; (viii) drug delivery is completed; and (ix) removing the device. A system or method can determine a specific operating state within each general operating state; for example, a system or method can determine whether the plunger has moved from the first end of the hole (limiting the hole of the drug reservoir) to the second end of the hole to determine whether the drug delivery device is in a "drug delivery completed" state.

[0132] In addition, the system or method can determine whether the drug delivery device is in one or more conditional states (i.e., states related to the condition of the drug delivery device, not necessarily related to the operation of the drug delivery device to deliver the drug to the patient). A non-exhaustive list of conditional states can include (i) expiration date (e.g., relative to the manufacturing date or expiration date); (ii) sterility / contamination; (iii) temperature (or temperature history); and (iv) orientation. The determination of the conditional state can be considered as part of the determination of the operational state; for example, the determination of the temperature state can be considered as part of the determination of the "ready to administer" state. Alternatively, the operational state and the conditional state can be determined separately.

[0133] One use for a needle insertion signal could be to release the delivery lock once the needle has been inserted into the patient. Alternatively, if drug delivery is complete and the needle is inserted for the entire time period between "delivery trigger" and "delivery complete," a very high degree of confidence in successful drug delivery is provided. Conversely, if the timing of the events does not overlap appropriately, the successfully delivered dose can be predicted based on the system delivery characteristics. In the event that an incomplete or unsuccessful administration is detected and reported, there is significant incremental value if the amount of the dose difference is also reported. "Smart drug delivery devices" can be used for many different types of medications with different therapeutic efficacy and toxicity risk profiles. For example, if there is a low risk of toxicity but a high risk of complications associated with missed or incomplete doses, some medications may require urgent completion of administration, for example, a second injection for any incomplete dose. Alternatively, if the risk of complications is low, healthcare providers may prefer to know about a missed or incomplete dose but wait for the next dose, rather than arrange for a replacement. Importantly, if missed doses are properly recorded and reported, there may be an opportunity to mitigate the problems associated with incomplete administration by administering only the missed dose, thereby providing the opportunity to maximize benefit while minimizing overall cost of care.

[0134] Those skilled in the art will appreciate that for single dose embodiments, upon completion of dose delivery, the embodiment may be configured to evacuate the entire contents of the compressed gas source by evacuating the non-medicament chamber adjacent the plunger stop.

[0135] It should be understood that the foregoing description provides examples of the disclosed automatic injection devices and techniques. However, it is contemplated that other embodiments of the present disclosure may differ in detail from the foregoing examples. More generally, all references to the present disclosure or its examples are intended to reference the specific example being discussed at that time and are not intended to imply any limitation on the scope of the present disclosure. All distinctions and derogatory language regarding certain features are intended to indicate a lack of preference for those features, but unless otherwise indicated, these features are not entirely excluded from the scope of the present disclosure.

[0136] Recitation of ranges of values ​​herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context.

[0137] The above description describes various systems and methods for use with drug delivery devices. It should be understood that the systems, drug delivery devices, or methods may further include the use of the medicaments listed below, but it should be noted that the following list should not be considered exhaustive or limiting. The medicament will be contained in a reservoir. In some cases, the reservoir is a primary container filled or prefilled for treatment with the medicament. The primary container can be a cartridge or a prefilled syringe.

[0138] Examples of other pharmaceutical products for use with the device may include, but are not limited to, antibodies such as (panitumumab), Xgeva TM (denosumab) and Prolia TM (denosamab), (trastuzumab), RITUXAN (rituximab / hyaluronidase), Darzalex (daratumumab and hyaluronidase), (pembrolizumab), (talquetamab-tgvs), (teclistamab-cqyv), etc.; other biological agents, such as Enbrel@ (etanercept, TNF receptor / Fc fusion protein, TNF blocker), (pegfilgrastim, pegylatedfilgastrim, pegylated G-CSF, pegylatedhu-Met-G-CSF), Neupogen@ (filgrastim, G-CSF, hu-MetG CSF), and (romiplostim); synthetic proteins, such as (glatirameracetate), etc.; small molecule drugs such as (cinacalcet), Uzedy (risperidone), etc. The device can also be used with therapeutic antibodies, polypeptides, proteins, synthetic peptides or other chemicals (such as iron), for example, nano iron oxide (ferumoxytol), dextran iron (iron dextrans), ferric gluconate (ferric glyconate) and sucrose iron. The drug product can be in liquid form or reconstituted from a lyophilized form. As used herein, antibodies, polypeptides, proteins and / or synthetic peptides include fusions, fragments, analogs, variants or derivatives thereof.

[0139] It should be noted that the configuration of the various embodiments of drug delivery device and drug delivery system as described herein is only illustrative. Although only several embodiments of drug delivery device and drug delivery system are described in detail in the present disclosure, it will be readily understood by those skilled in the art who read the present disclosure that, in fact, many modifications are possible (for example, the size, size, structure, shape and ratio, parameter value, installation arrangement, use of material, orientation etc. of various elements) without departing from the novel teachings and advantages of the subject matter of the present disclosure. For example, any combination of one or more of sensor and sensor system as described herein can be incorporated into one or more of drug delivery system and drug delivery device as described herein. In addition, according to alternative embodiments, the order or sequence of any process or method step as described herein can be changed or reordered in any combination. In addition, any combination of one or more elements of one or more claims set forth at the end of the present disclosure is possible.

[0140] Although the preceding text sets forth a detailed description of various embodiments of the present invention, it should be understood that the legal scope of the present invention is defined by the language of the claims set forth at the end of this patent. The detailed description is provided for illustrative purposes only and does not describe every possible embodiment of the present invention, as describing every possible embodiment would be impractical, if not impossible. Numerous alternative embodiments can be implemented using current technology or technology developed after the filing date of this patent and still fall within the scope of the claims defining the present invention.

[0141] It should also be understood that unless a term is expressly defined in this patent using the sentence "As used herein, the term 'x' is hereby defined to mean 'y'" or similar sentences, there is no intention to limit the meaning of that term (whether expressly or by implication) beyond its plain or ordinary meaning, and such terms should not be construed as limited in scope based on any statement made in any part of this patent (except the language of the claims). To the extent that any term recited in the claims at the end of this patent is referred to in this patent in a manner consistent with a single meaning, this is solely for clarity so as not to confuse the reader and is not intended to limit such claim term to that single meaning, by implication or otherwise. Finally, unless a claim element is defined by reciting the words "means" and function without reciting any structure, the scope of any claim element is not intended to be construed based on the application of the sixth paragraph of 35 U.S.C. §112.

Claims

1. An automatic injection device comprising: a syringe comprising a barrel, a syringe needle fluidly coupled to an interior of the barrel, and a plunger stop configured to translate within the barrel, the plunger stop being radially disposed within the barrel, the plunger stop dividing the interior of the barrel into a medication space, the medication space being configured to contain an injectable medication between the plunger stop and the syringe needle; a slider coaxially disposed with respect to the syringe, the slider being rotatably disposed relative to the syringe and being substantially axially fixed relative to the syringe; a member axially adjacent to the plunger stopper, wherein the axial position of the member is synchronized with the axial position of the plunger stopper within the barrel; a needle safety shield slidably disposed relative to the syringe and the slider, whereby an axial force applied to the needle safety shield causes the needle safety shield to slide relative to the syringe from a guard position, in which the syringe needle is not axially exposed, to an injection position, in which the syringe needle is axially exposed to penetrate an injection site, to actuate a force applied to the plunger stop; wherein movement of the needle safety shield is at least partially guided by an arrangement of pins and tracks, one of the pins and tracks being formed with the needle safety shield and the other of the pins and tracks being formed with the slider, whereby movement of the pin within the track controls the position of the needle safety shield relative to the slider, the track including a point of no return, the pin being disposed in the track proximal to the point of no return such that the needle safety shield remains axially movable to the injection position, the pin returning the needle safety shield to the guarding position when the axial force is removed, the applied force being removed in the injection position, and the pin being disposed in the track distal to the point of no return as the slider rotates such that the pin moves and locks the needle safety shield in the guarding position when the axial force is removed; and wherein rotation of the slider is actuated by movement of the member moving synchronously with the plunger stop, the member rotating the slider to position the safety shield pin to be guided along the track including the point of no return to axially lock the needle safety shield in the guard position when the plunger stop reaches the end of all dose delivery.

2. The automatic injection device of claim 1, further comprising a status indicator that qualitatively and quantitatively indicates the progress of delivery of the injectable drug from the syringe.

3. The automatic injection device according to claim 2, wherein: The status indicator comprises a dose indicator.

4. The automatic injection device according to claim 3, wherein: The dose indicator is slidably disposed within a dose indicator window and is tethered to a member axially adjacent to and moving synchronously with the plunger stop, such that a position of the dose indicator relative to the dose indicator window indicates an axial position of the plunger stop relative to the syringe.

5. A method for administering a divided dose by an automatic injection device, comprising the following steps: retracting the needle safety shield from a non-use position to actuate the automatic injection device; applying a force to cause the member to move synchronously with a plunger stop configured to translate within the syringe or barrel; interrupting the operation of the automatic injection device by removing the force applied to the plunger stop, translating the needle shield pin along the original track of the slider to its non-use state, and removing the applied force; resuming operation of the automatic injection device by reapplying a force on the plunger stop, wherein the force is actuated by retraction of the needle safety shield; When the slider is oriented to guide the radial pin of the needle safety shield to a point of no return locking the needle safety shield, the automatic injection device operation is completed by removing the force applied for translation of the plunger stopper.

6. The method according to claim 5, wherein: The automatic injection device also includes a status indicator that qualitatively and quantitatively indicates the progress of delivery of the injectable drug from the syringe.

7. The method according to claim 6, wherein: The status indicator comprises a dose indicator.

8. The method according to claim 7, wherein: The dose indicator is slidably disposed within a dose indicator window and is tethered to a member axially adjacent to and moving synchronously with the plunger stop, such that a position of the dose indicator relative to the dose indicator window indicates an axial position of the plunger stop relative to the syringe.

9. An automatic injection device comprising: a barrel comprising a barrel body, a plunger stopper configured to translate within the barrel body, the plunger stopper being radially disposed within the barrel body, the plunger stopper dividing an interior of the barrel body into a medication space, the medication space being configured to contain an injectable medication between the plunger stopper and a barrel crimp stopper; a slider coaxially disposed with the barrel, the slider being rotatably disposed relative to the barrel and substantially axially fixed relative to the barrel; a member axially adjacent to the plunger stopper, wherein the axial position of the member is synchronized with the axial position of the plunger stopper within the barrel; a needle safety shield slidably disposed relative to the barrel and the slider, whereby an axial force applied to the needle safety shield causes the needle safety shield to slide relative to the barrel from a guard position in which an injection needle axially keyed to the needle safety shield is not axially exposed to an injection position in which the injection needle is axially exposed to penetrate an injection site; wherein movement of the needle safety shield is at least partially guided by an arrangement of a pin and a track, one of the pin and the track being formed with the needle safety shield and the other of the pin and the track being formed with the slider, whereby movement of the pin within the track controls the position of the needle safety shield relative to the slider, the track including a point of no return, wherein when the pin is disposed in the track proximal to the point of no return so that the needle safety shield remains axially movable to the injection position, when the axial force is removed, the pin returns the needle safety shield to the guard position, and when the pin is disposed in the track distal to the point of no return as the slider rotates, when the axial force is removed, the pin moves and locks the needle safety shield in the guard position; wherein rotation of the slide is actuated by movement of the member moving synchronously with the plunger stop, the member rotating the slide to position the safety shield pin to be guided along the track including the point of no return to axially lock the needle safety shield in the guard position when the plunger stop reaches the end of all dose delivery; wherein as the pin travels from the injection position to the guard position, a force applied to the plunger stop is counteracted by a component introduced into the path of a component coupled to the member; and Wherein, the needle safety shield with interlocking injection needle is removable after the safety shield pin is at the point of no return.

10. The automatic injection device according to claim 9, wherein: A portion of the member is radially disposed within the barrel and seals against the barrel.

11. The automatic injection device of claim 9 , further comprising a reservoir containing a disinfectant, the reservoir being disposed between the injection needle and the non-medicament side of the barrel crimp stopper and being configured such that when the needle safety shield is moved from the guard position to the injection position, the injection needle passes through the reservoir before piercing the barrel crimp stopper to fluidically couple to the interior of the barrel.

12. The automatic injection device of claim 9, further comprising a status indicator that qualitatively and quantitatively indicates the progress of delivery of the injectable drug from the syringe.

13. The automatic injection device according to claim 12, wherein: The status indicator comprises a dose indicator.

14. The automatic injection device according to claim 13, wherein: The dose indicator is slidably disposed within a dose indicator window and is tethered to a member axially adjacent to and moving synchronously with the plunger stop, such that a position of the dose indicator relative to the dose indicator window indicates an axial position of the plunger stop relative to the syringe.

15. A sterile automatic injection device comprising a pre-installed sterile container, the sterile container being operably connected to a fluid port via a connector, wherein the connector bypasses a plunger stop radially disposed within the container and sealed against the container, the container being positioned for delivering a preset injection volume; wherein the connector and fluid port are configured to be removed once the container is filled to the preset injection volume; and wherein the plunger stop is configured to seal radially once the connector is disconnected from the container.

16. The automatic injection device according to claim 15, wherein: The connector is a hollow tube.

17. The automatic injection device according to claim 15, wherein: The sterile container is a cartridge.

18. The automatic injection device according to claim 15, wherein: The fluid port is a female Luer connector.

19. The automatic injection device according to claim 15, wherein: Before filling the container with the injectable fluid, all other components involved in normal automatic injection device operation are in a ready-to-use condition.

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