rechargeable autoinjector and method for operating a rechargeable autoinjector

专利摘要:
The present invention relates to a refillable autoinjector which is described in which a syringe assembly is positioned movable between a first position in which the needle is accommodated within a housing and a second position in which the needle projects to outside the housing The syringe assembly comprises a syringe, a plunger rod, and a plunger rod actuator configured to apply a force to the plunger rod to advance the plunger rod into the syringe to deliver at least one dose of medication. A syringe driver is configured to apply a force to the syringe assembly thereby moving the syringe assembly from the first position to the second position. A refill handle may be connected to the syringe assembly so that a user's operation of the handle refill moves the syringe assembly back to the first position and simultaneously reloads the syringe driver to thereby prepare the auto injector to deliver an additional dose of medication. Plunger rod trigger is not reactivated.
公开号:BR112014005489B1
申请号:R112014005489-4
申请日:2012-09-10
公开日:2021-06-08
发明作者:Soeren Bechmann；Flemming Madsen；Esben W. Johansen
申请人:Merck Patent Gmbh；
IPC主号:

专利说明:

FIELD OF TECHNIQUE
[001] The present invention relates to autoinjectors, such as medical autoinjectors, and especially to refillable autoinjectors which may be capable of delivering one or more individual doses from a medical cartridge or a pre-filled syringe containing a drug the refilling of the autoinjector may require an operator override input to allow an additional dose to be delivered. Autoinjectors can be configured for single or multiple uses. BACKGROUND OF THE INVENTION
[002] Autoinjectors are well known in the art, and are often preferred by users for self-administration of medication, such as for subcutaneous injection of medications such as insulin, medication to treat or alleviate multiple sclerosis, rheumatism, lupus, etc. or for emergency injection of, for example, adrenaline or epinephrine, such as an injection into muscle tissue.
[003] The needles used for subcutaneous injection and for injection into muscle tissue are typically of different lengths. Typically, needles used for subcutaneous injections are approximately 12 mm ("half inch") while needles used for injection into muscle tissue can be 20-25 mm ("1 inch") long, to ensure that the muscle tissue is reached.
[004] The selected needle hole may also affect the degree of patient discomfort during the injection. Smaller bore diameters typically provide more patient comfort, while larger bore diameters allow for faster application of liquid through the needle and with less force. A compromise is therefore needed in pinhole selection to provide acceptable patient comfort and fluid delivery through the needle characteristics.
[005] Allergic reactions tend to become an ever-increasing problem and for the treatment of severe allergic reactions (anaphylaxis) to food, insect stings or bites, drugs and other allergens, as well as idiopathic or exercise-induced anaphylaxis, adrenaline or epinephrine is typically used.
[006] Epinephrine works quickly to reverse the symptoms of an anaphylactic reaction, and epinephrine injected into the muscle of the front of the upper outer thigh is typically used for the emergency treatment of anaphylaxis.
[007] Typically, epinephrine autoinjectors are single-use injectors to inject a premeasured single dose of epinephrine for the treatment of emergency anaphylaxis.
[008] However, when administering some drugs, such as epinephrine, a single dose may not be sufficient to treat anaphylaxis. In order for a patient to be able to receive a total treatment that includes one, two or more doses with a single injector, different autoinjectors have been suggested.
[009] Different possibilities for the injection of two doses of the same syringe have been suggested and in US 7,927,303 and EP700307, two-dose autoinjectors are described that allow the automatic application of a first dose of a drug and the manual refilling of the drug. autoinjector so that the syringe once used can be reinserted into the autoinjector for the administration of a second dose.
[0010] In WO 2011/111006, an autoinjector is described in which the locking and release of the actuating spring of the autoinjector is controlled by providing a stepped guide means with ramps for two successive slides along these of a spring operated and connected sliding means with the syringe and relevant plunger. Thus, after a first dose has been delivered, an additional dose can be delivered using the same spring and slide the syringe further along the sliding means.
[0011] It is a disadvantage of the described autoinjector that the length of the device significantly increases when a second dose is applied.
[0012] There is therefore a need for an autoinjector which allows the selective application of one or more doses, with subsequent doses also being automatically applied which is compact in size. SUMMARY OF THE INVENTION
[0013] It is an object of the present invention to provide a self-refillable injector that overcomes one or more of the disadvantages of the prior art.
[0014] According to a first aspect of the present invention a refillable autoinjector with a housing for accommodating a syringe assembly is provided. The syringe assembly may comprise a syringe with a needle, and the syringe assembly may be positioned movable within the housing between a first position in which position the needle is accommodated within the housing and a second position in which position the needle protrudes outwardly of the accommodation. The syringe assembly may further comprise a plunger rod configured to be advanced within the syringe to deliver at least one dose of medication, and a plunger rod driver being configured to apply a force to the plunger rod to advance the rod. plunger into the syringe for delivering at least one dose of medication. Furthermore, a syringe driver can be accommodated within the housing and configured to apply a force to the syringe assembly thereby moving the syringe from the first position to the second position. The autoinjector may further comprise a refill handle configured to refill the autoinjector to inject an additional dose of medication, the refill handle may be connected to the syringe assembly so that the operator or patient operation of the refill handle is configured to withdraw the syringe assembly to the first position and simultaneously reload the syringe driver to thereby prepare the autoinjector to deliver an additional dose of medication. A syringe cap can be positioned movable within the syringe and seal the syringe contents and the plunger rod can be configured to engage the syringe cap.
[0015] In another aspect of the present invention, a refillable autoinjector with a housing for accommodating a syringe assembly comprising a syringe with a needle is provided. The syringe assembly may be movable positioned within the housing between a first position in which position the needle is accommodated within the housing and a second position in which position the needle projects out of the housing. The syringe assembly may further comprise a plunger rod driver being configured to apply a force to a plunger rod to advance the plunger rod within the syringe to deliver at least one dose of medication. The housing can further accommodate a syringe driver configured to apply a force to the syringe assembly thereby moving the syringe from the first position to the second position and the autoinjector further comprises a refill handle configured to reload the autoinjector to inject a dose additional medication. The refill handle can be connected to the syringe assembly so that operator or patient operation of the refill handle is configured to withdraw the syringe assembly to the first position and simultaneously refill the syringe driver.
[0016] In yet a further aspect of the present invention, a refillable autoinjector with a housing for accommodating a needle guard and a syringe assembly is provided. The syringe assembly may comprise a syringe with a needle and a plunger rod driver being configured to apply a force to a plunger rod to advance the plunger rod into the syringe to deliver at least one dose of medication. A syringe driver can be configured to apply a force to the syringe assembly thereby moving the syringe from a first position to a second position and a refill handle can be configured to reload the autoinjector to apply an additional dose of medication, being that the refill handle is connected to the syringe assembly and the needle shield so that the operator or patient operation of the refill handle is configured to withdraw the syringe assembly to the first position and simultaneously reload the syringe driver and release the needle protection.
[0017] In another aspect of the present invention, a method for refilling an autoinjector is provided, wherein a refillable autoinjector has a housing for accommodating a needle shield and a syringe assembly. The syringe assembly may comprise a syringe with a needle and a plunger rod driver being configurable to apply a force to a plunger rod to advance the plunger rod within the syringe for delivering at least one dose of medication. A syringe driver may be provided within the housing and configured to apply a force to the syringe assembly thereby moving the syringe from a first position to a second position into which position a dose can be delivered. The autoinjector may further comprise a refill handle configured to reload the autoinjector to deliver an additional dose of medication, the method comprising operating the refill handle to retract the syringe assembly to the first position, reload the syringe driver and release the needle shield and thereby prepare the autoinjector to deliver an additional second dose.
[0018] In yet a further aspect of the present invention, a method for operating a rechargeable autoinjector is provided. The auto-injector may comprise a housing for accommodating a syringe assembly. The syringe assembly may comprise a syringe with a needle, and the syringe assembly may be positioned movable within the housing between a first position in which position the needle is accommodated within the housing and a second position in which position the needle projects outwardly of the accommodation. The syringe assembly may further comprise a plunger rod driver being configured to apply a force to a plunger rod to advance the plunger rod within the syringe to deliver at least one dose of medication and the housing may further accommodate a syringe driver configured to apply a force to the syringe assembly thereby moving the syringe from the first position to the second position, a skin sensor for activating the autoinjector, a syringe lock to lock the syringe assembly into the first position, and a refill handle where the method can comprise the steps of activating the skin sensor to turn the syringe lock and release the syringe assembly, move the syringe assembly from the first position to the second position, release the rod driver of plunger to deliver a dose of medication, deactivate the skin sensor to cover the needle and lock the skin sensor in the deactivated position. The method may further comprise reloading the autoinjector by operating the refill handle, the reloading may comprise moving the syringe assembly from the second position to the first position, reloading the syringe driver, locking the syringe assembly into the first position, and unlock the skin sensor whereby the autoinjector is ready to deliver an additional dose of medication.
[0019] In yet another aspect of the present invention, an autoinjector for delivering at least one dose of drug is provided. The autoinjector may have a housing for accommodating a syringe assembly comprising a syringe with a needle. The syringe assembly may be movable positioned within the housing between a first position in which position the needle is accommodated within the housing and a second position in which position the needle projects out of the housing. The autoinjector may further comprise a sound generator configured to emit a sound while dosing.
[0020] It is an advantage of the present invention that the autoinjector can be used to deliver one or more doses of medication, depending on the operation of the user or patient of the autoinjector. Thus, one or more individual doses can be delivered from, for example, a medical cartridge or a pre-filled syringe containing the drug. It is an advantage of the present invention that an operator or patient override input is required in order to allow an additional dose to be delivered. Operator input may comprise operating a refill mechanism, and the refill mechanism may comprise activating the autoinjector for further injection.
[0021] It is an advantage of the autoinjectors described above that the mechanism is fully reversible. Hereby, any sharp tip protection in the form of a skin sensor or the like can be locked in the intermediate position, ie after a first dose is applied and before the autoinjector is refilled. Hereby, the patient is protected against the needle also between dose applications. It is especially for the acute treatment of, for example, allergies, it is advantageous that the needle protection can be locked after the application of the first dose or injection of the first dose, as the patient may not need further treatment and thus discard or reuse the autoinjector after the application of the first dose. Thus, to safely dispose of the autoinjector or syringe assembly, the skin sensor can advantageously protect the needle after a dose has been applied and can even more be locked in the forward position immediately after a dose delivery.
[0022] It is an additional advantage of the present invention that the auto-injector has a compact size with the syringe assembly and needle guard being recessed when reloading the device, thereby limiting the length of the device.
[0023] The present invention can provide an autoinjector which allows a patient to have at least two individual injections of a single syringe, and the operator or patient can apply similar steps to perform the first, second and any additional injections. The operator or patient may need to activate the autoinjector to allow for a second or additional injection or drug delivery.
[0024] Throughout the present description, the autoinjector has a forward or forward end at the end intended to be pushed against a patient's skin, and a rear or backward end towards the other end of the autoinjector. The terms "forward" or "downward", such as a forward or downward movement, therefore, means towards the front end, or towards the skin of a patient when the autoinjector is positioned in its intended operating position for injection. Likewise, backward or upward, such as backward or upward movement, means towards the rear end of the autoinjector, or away from a patient's skin when the autoinjector is positioned in its intended operating position for injection . Furthermore, an upper end of the autoinjector is the rear end of the autoinjector, i.e. the end furthest away from a patient's skin when the autoinjector is positioned in its intended operating position for injection.
[0025] Furthermore, the term "refill" means to prepare the autoin-jector for an additional injection using the same or a different syringe. Autoinjector refill is performed while the syringe is fitted in the autoinjector. When a trigger, such as a spring, is recharged or reactivated, energy is transferred back to the trigger. For example, recharging or reactivating a spring comprises recharging tension on the spring.
[0026] In one or more embodiments of the present invention, the rechargeable auto-injector can be activated when unpacking the device. Especially for emergency medicine injections, it is advantageous for an operator or patient that no additional steps are required after unpacking the device and before activating the autoinjector, such as pushing the skin sensor against a patient's skin.
[0027] In one or more embodiments of the present invention, the syringe driver and the plunger rod driver are separate drivers. Thus, the syringe driver can separate from the plunger rod driver, and in some embodiments, the syringe driver can be a resilient device, such as a spring, such as a compression spring. Likewise, the piston rod driver can be a resilient device, such as a spring, such as a compression spring. The syringe driver may be configured to act on the syringe assembly to drive the syringe assembly from the first position to the second position. The syringe driver can be provided within the housing and the housing can guide or stabilize the syringe driver. The piston rod actuator may be configured to act on the piston rod and may be provided with a piston rod tube. The plunger rod tube can guide or stabilize the plunger rod driver.
[0028] The autoinjector may in some embodiments further comprise a syringe lock configured to lock the syringe in the first position, and a skin sensor configured to release the syringe lock when coupling with a patient's skin. skin is activated by pressing the skin sensor onto a patient's skin.
[0029] The skin sensor may thus be of a cylindrical shape that encompasses at least a part of the syringe assembly and the skin sensor may be configured to connect to a skin sensor driver. The skin sensor trigger can be a resilient trigger, such as a spring. In one or more embodiments, the skin sensor trigger is a spring, and the spring can be configured to be in the relaxed position when the skin sensor is positioned in a forward position. The skin sensor can, for example, be activated when pressing the skin sensor against a patient's skin. Hereby, the operator can compress the skin sensor trigger, such as the spring, and move the skin sensor backwards away from the skin. The compressed skin sensor trigger, such as the spring, can be released as soon as the autoinjector is removed from the skin and the skin sensor will thereby be pushed forward by the skin sensor trigger.
[0030] In one or more embodiments, the autoinjector may further comprise safety features, such as a needle guard element, such as a needle guard, to protect the needle and prevent accidental contact with the needle. In some embodiments, the skin sensor can protect the needle and thus act as a skin sensor configured to release the syringe driver as mentioned above, and further act as a needle shield element configured to protect the needle. It is, however, envisaged that the needle guard element such as the needle guard can be a separate element from the skin sensor. In the following, reference can be made to the skin sensor, however, it will be clear to a person skilled in the art that corresponding needle guard characteristics could be uniformly applied to a separate needle guard element from the skin sensor.
[0031] The needle protection element, like the skin sensor, may be able to lock in a forward position so as to prevent accidental contact with the needle. The needle protection element can, for example, be locked after a dose has been injected, and between multiple injections. The needle guard element may, for example, comprise a locking protrusion and the locking protrusion may be configured to rest on an edge of the syringe lock when a first dose has been applied by locking the needle guard element in the forward position and preventing rearward movement of the needle guard element. It is envisaged that the locking of the needle protection element. It is also envisaged that the locking of the needle guard element can also be implemented using any other locking mechanism.
[0032] The skin sensor can likewise have a front locked position and a front unlocked position, and the skin sensor can, for example, be locked after each injection cycle has been completed. It is an advantage to lock the skin sensor after an injection cycle has been completed as the risk of accidental activation of the autoinjector for an additional injection is minimized or eliminated. By locking the skin sensor in the front locked position, this requires an operator or patient override input to reactivate the autoinjector and prepare it for an additional injection cycle. The skin sensor may, for example, comprise a locking protrusion and the locking protrusion can be configured to rest on an edge on the cylinder lock when a first dose has been applied by locking the skin sensor in the forward position and preventing a back movement of the skin sensor. It is envisioned that the locking of the skin sensor can be implemented using any other locking mechanism.
[0033] The refill handle can be configured to further interact with the needle protection element and/or the skin sensor to unlock the needle protection element and/or the skin sensor when recharging, and in one or more In embodiments, rotation of the refill handle rotates the syringe lock to thereby unlock the needle guard element and/or the skin sensor. In the unlocked position, a backward movement of the needle protection element and/or the skin sensor can be allowed to thereby prepare the autoinjector for an additional injection. In one or more embodiments, the needle shield element and/or the skin sensor is in an unlocked position when unpacking the device and locked after a dose of medication has been delivered.
[0034] It is an advantage of providing the autoinjector in a ready-to-use state directly out of the package as the autoinjector can be applied for emergency medicine injections, such as for an anaphylaxis allergy reaction, etc. Thus, for a patient or user, it is of utmost importance that no consideration or user manual regarding the functioning of the auto-injector is required, but that the device can inject the drug directly by pushing the auto-injector against the skin.
[0035] It is an advantage to provide a locking of the needle protection element and/or the skin sensor after the application of a dose and the autoinjector in this state can either be discarded or wait for an additional injection of medication. In both cases it is advantageous that there is limited or no risk for a patient, a user or anyone handling the discarded autoinjector to contact the needle and/or accidentally activate the autoinjector to run an additional dose injection cycle .
[0036] Using the refill mechanism to additionally unlock safety features, such as the needle protection element, the skin sensor, etc., provides the advantage of having an autoinjector with safety features which is fully reversible when recharging the device. Hereby an autoinjector can be provided with the safety features of a standard autoinjector provided in a fully reversible rechargeable autoinjector.
[0037] The syringe can be locked in the first position when the autoinjector is in a position ready to deliver a dose. The syringe can thus be locked in the first position initially, that is, when the autoinjector is unpacked, and after each refill action. The syringe can be locked in the first position by a syringe lock. The syringe lock can, for example, be released when activating the skin sensor.
[0038] Activation of the skin sensor can be configured to cause a backward movement of the skin sensor whereby a sloped skin sensor surface can be configured to mate with a sloped syringe latch surface that translates the movement side of the skin sensor in an angular movement of the syringe lock. The skin sensor can, for example, be activated by pressing the skin sensor against a patient's skin to thereby force the skin sensor backwards. The syringe lock can be cylindrical in shape and can be configured so that the skin sensor, when moving backwards, slides into the syringe lock. The skin sensor slanted surface can thus be a bulge on an outer side of the skin sensor, and the syringe lock slanted surface can be a bulge on an inner syringe lock side, so that when the skin sensor slides within the syringe latch the skin sensor slanted surface and the syringe latch slanted surface can mate so that the skin sensor slanted surface thereby forces the syringe latch to rotate.
[0039] The syringe latch may further comprise a supporting edge, and the syringe assembly may rest on the bearing edge on the syringe latch to thereby lock the syringe assembly into the first position. Angular movement of the syringe latch can release the syringe assembly by rotating the syringe latch and thereby releasing the syringe assembly from the bearing edge.
[0040] In one or more embodiments, the syringe lock may further comprise a syringe lock guide slit, and the syringe assembly may comprise a syringe assembly tab; the syringe assembly tab may be configured to move within the syringe lock guide slot. The syringe latch guide slot may comprise the bearing edge, and rotation of the syringe latch may move the tab within the bearing edge guide slot to a released position in which the syringe assembly tab may follow a guide slit path downward from the released position adjacent the edge to a syringe lock end stop thereby moving the syringe assembly from the first position to the second position. Thus, the syringe assembly can be moved from the first position to the second position when the syringe assembly end stop moves within the syringe lock guide slot from the released position to the syringe lock end stop.
[0041] At least a part of the guide slit may comprise an inclined guide slit so that the syringe latch can be further rotated when moving the syringe assembly from the first position to the second position.
[0042] The syringe assembly can thus be locked in the first position where forward movement is restricted by the syringe lock such as the supporting edge. As the syringe lock is rotated, the syringe assembly can be free to move forward and the syringe driver can thereby be released to move the syringe assembly from the first position to the second position. Forward movement can thus be restricted by the syringe assembly tab engaging a syringe lock end stop. A distance along the longitudinal axis of the autoinjector from the bearing edge to the end stop can thus indicate the path of the needle from the first position to the second position and by this the end stop can define the insertion depth for the needle.
[0043] It is seen that the syringe lock can control movement, such as forward movement, and, for example, movement from the first position to the second position, of the syringe and/or the syringe assembly. Thus, the syringe lock can control needle insertion.
[0044] The syringe assembly may comprise a syringe tube coaxially covering the syringe and a plunger rod tube coaxially spanning the plunger rod, the syringe tube and the plunger tube being interconnected through connectors. Engageable syringe tube with the plunger rod connectors.
[0045] The piston rod actuator may at one end be fixedly connected to a rear end of the piston rod tube and at the other end be configured to engage the piston rod. The plunger rod actuator can be locked while the syringe assembly is moved from the first position to the second position, and thus the plunger rod can be held in the same position while the syringe assembly is moved from the first position to the second position. Thus, the plunger rod driver, the plunger rod and the plunger rod tube can be moved forward by the syringe driver.
[0046] The plunger rod may be configured to be released when the syringe assembly is in the second position thereby activating the plunger rod actuator to move the plunger rod forward. Hereby, the plunger rod can engage the syringe cap and thereby force the syringe cap forward and deliver a dose of medicine. The plunger rod may typically move forward a predetermined distance within the syringe before a plunger rod stop engages the plunger rod and prevents further forward movement of the plunger rod. The predetermined distance can indicate the amount of medicine applied, depending on the syringe size.
[0047] The piston rod actuator may be configured to move the piston rod by a first predetermined distance upon a first activation of the piston rod actuator, a second predetermined distance when upon a second activation of the piston rod actuator, an additional predetermined distance when further activating the piston rod driver, etc., before coupling a first piston rod stop, a second piston rod stop and/or any additional piston rod stops. The first, second, and/or additional predetermined distances may be different distances to allow different doses of drug to be delivered following a first, second, and/or additional activations of the autoinjector.
[0048] The second or further activation of the piston rod driver may follow a reload of the autoinjector, and thus follow any movement of the syringe assembly from the first position to the second position. Moving the syringe assembly from the first position to the second position may thus comprise moving the plunger rod, the plunger rod driver and the plunger rod tube with the syringe assembly. Hereby, the plunger rod may remain locked onto any plunger rod stop, and the plunger rod driver may not be able to drive the plunger rod forward while moving the syringe assembly from the second to the first position. position. The plunger rod may, after a first injection cycle has been completed, not be released until the syringe assembly, after activation of the autoinjector, is moved from the first position to the second position a second and/or additional time .
[0049] In one or more embodiments of the present invention, an autoinjector having sequential needle insertion and dose injection control is provided. The autoinjector may have a housing for accommodating a syringe with a needle and the syringe may be positioned movable within the housing between a first position in which position the needle is accommodated within the housing and a second position in which position the needle projects outwards of the accommodation. The housing may further accommodate a plunger rod configured to be advanced into the syringe to deliver at least one dose of medication, and a plunger rod tube. The piston rod tube may have at least one locking member configured to interact with a piston rod stop to normally lock the piston rod into the piston rod tube. A syringe driver may be configured to apply a force to the syringe thereby moving the syringe from the first position to the second position and the syringe driver may further be configured to advance the plunger rod tube with the plunger rod towards the second position. A plunger rod actuator may be configured to apply a force to the plunger rod to advance the plunger rod within the syringe to deliver at least one dose of medication. The housing may be configured to unlock the locking member and release the plunger rod from the plunger rod tube when the syringe and plunger rod tube are advanced to the second position. Hereby the plunger rod actuator can be activated to advance the plunger rod within the syringe to deliver at least one dose of medication. Thus, the syringe driver and the plunger rod driver can be separate drivers.
[0050] It is advantageous to provide a syringe driver and a plunger rod driver as separate actuation means in that the risk of wet injection, i.e. liquid medicine leaking out of the needle during needle insertion, is reduced.
[0051] According to one or more other embodiments of the present invention, an autoinjector having sequential needle insertion and dose injection control is provided. The autoinjector may have a housing for accommodating a syringe with a needle, and the syringe may be positioned movable within the housing between a first position in which position the needle is accommodated within the housing and a second position in which position the needle projects to outside the accommodation. The housing may further accommodate a plunger rod configured to be advanced into the syringe for delivering at least one dose of medication, and a plunger rod tube. The piston rod tube may have at least one locking member configured to interact with a piston rod stop to normally lock the piston rod into the piston rod tube. A first spring may be configured to apply a force to the syringe thereby moving the syringe from the first position to the second position, and the first spring may further be configured to advance the plunger rod tube with the plunger rod towards the second position. A second spring may be configured to apply a force to the plunger rod to advance the plunger rod within the syringe to deliver at least one dose of medication. The housing may be configured to unlock the locking member and release the plunger rod from the plunger rod tube when the syringe and plunger rod tube are advanced to the second position. Hereby the second spring can be activated to advance the plunger rod within the syringe to deliver at least one dose of medication.
[0052] It is a further advantage to provide a first spring configured to advance the syringe within the housing and a second spring configured to advance the plunger rod within the syringe that the spring characteristics can be selected according to the purpose. For example, to drive a needle into the skin a significantly less force may typically be required than when injecting a drug from a syringe depending on the needle hole. So, especially when the initial force is lower than the force required for injecting the medicine, the design of the springs can be complex, and hardly achievable by a single spring.
[0053] Specifically when injecting a drug into muscle tissue, a longer needle is typically used compared to needles used for subcutaneous injections. As a result of the long needle size and still the requirement for minimal force to facilitate drug injection into muscle tissue, significant force may need to be stored in the spring. A high potential energy stored in the spring during the entire shelf life of the autoinjector also adds to the requirements for the surrounding parts of the autoinjector specifically with regard to strength and with it the cost of manufacture.
[0054] Furthermore, when manufacturing autoinjectors in high volume, the tight tolerances required when using a single spring for both needle insertion and drug injection can be critical. Thus, it is a further advantage of the present invention that as few parts as possible move relative to one another to thereby obtain a system which is more robust with respect to the manufacturing process. Also, providing a spring for both inserting a needle and injecting a drug requires that the spring be able to extend over a significant length compared to spring diameters which can typically be provided on autoinjectors. Furthermore, the design of spring characteristics, such as force distribution, can be much simpler, and therefore reduce spring costs.
[0055] It is seen that the locking member cooperating with the housing or an intermediate member such as the refill handle can control the movement of the piston rod. Thus, the movement of the plunger rod and thereby the injection of medicine is controlled by the housing or the intermediate member.
[0056] It is a further advantage of the present invention that the means for releasing the syringe to allow insertion of the needle is uncoupled from the means for releasing the plunger rod for drug injection. Thus, there is no direct coupling between the end stop for the needle insertion, which is provided over the syringe lock, and the release of the plunger rod, which is provided by the alignment of the plunger rod tube and the housing or the intermediate member, such as the charging handle. Hereby, an inaccuracy in the needle injection procedure will not inherently be transferred to the drug injection. Thus, although the syringe release may be configured to release the plunger rod, the syringe release may be mechanically decoupled from the plunger rod release.
[0057] The locking member may comprise at least one deflectable member and the housing may be configured to allow the at least one deflectable member to allow deflection away from the plunger rod when the syringe and plunger rod tube have been advanced to the second position.
[0058] In one or more embodiments, the plunger rod tube and the syringe may be interconnected such that the plunger rod tube may not be able to move with respect to the syringe and vice versa.
[0059] The housing may have an opening, such as a window or an enlarged portion, configured to be aligned with the at least one deflectable member when the piston rod tube is advanced to the second position. By aligning the at least one deflectable member with the opening, the at least one deflectable member can be configured to deflect through or toward the opening. When the piston rod tube with the at least one deflectable member is not in the second position, an inner surface of the housing can prevent the at least one deflectable member from deflecting, such as deflecting outwardly, i.e., deflecting radially with with respect to a longitudinal axis of the syringe and/or the piston rod tube. Hereby, the plunger rod can be locked into the plunger rod tube and the plunger rod driver, like the second spring, will remain in a compressed state and will not be able to force the plunger rod into the syringe. . Only when the piston rod tube is aligned with the housing openings will the at least one deflectable member be able to deflect and thereby release or unlock the piston rod from the piston rod tube. As the plunger rod is released from the plunger rod tube, the plunger rod driver will be activated and will force the plunger rod to advance the syringe to thereby deliver a dose of medication.
[0060] Thus, when releasing the piston rod, the piston rod actuator can advance the piston rod into the syringe with the piston rod stopper being able to pass through the deflected locking member. Hereby, the front end of the plunger rod is advanced into the syringe, and the plunger rod stop can move forward to a dose end stop within the plunger tube. Hereby, the dose to be injected can be determined by the distance from the release of the plunger rod to the end-of-dose stop times a syringe diameter.
[0061] The piston rod stop may have an inclined surface that normally presses against an angled surface of the deflectable locking member. Hereby, the piston rod forces the deflectable locking member to deflect towards the opening when the piston rod is being pushed forward by the piston rod actuator.
[0062] In one or more embodiments, the at least one deflectable locking member can be hinged to the piston rod tube in a downward position with respect to movement of the piston rod. Hereby, the at least one deflectable locking member is stronger in that compressive forces, rather than pulling forces, are exerted on the at least one deflectable locking member. Another advantage of pivoting the deflectable locking member in a downward position is that it is ensured that the deflectable locking member can deflect only when the entire length of the deflectable locking member opposes full opening. This further implies that the autoinjector is more robust in controlling ensuring a strict sequential execution of drug injection only after a fully established needle insertion. Specifically, for acute medications with a very rapid injection of a drug, ie when a large-bore needle is used, it is of utmost importance that sequential control is robust.
[0063] As mentioned above, the piston rod actuator may comprise a spring, such as a compression spring, and in some embodiments, the piston rod spring may at one end be fixedly connected to the piston rod tube.
[0064] The piston rod driver can apply the actuating force directly over the piston rod, such as over a piston rod flange, in order, for example, to drive only the piston rod forward. It is an advantage of applying the actuating force directly over the piston rod as no complex parts can be needed to shift the load between the different parts, and what's more, the force can be applied in a controlled manner, with substantially no or significantly reduced uncertainty of how much force will actually be applied to the plunger rod, and thereby how fast the drug will be expelled.
[0065] The piston rod actuator, such as the second spring, may, for example, be provided inside the piston rod tube, and the syringe actuator, such as the first spring, may be provided outside the piston tube. piston rod.
[0066] The housing may further accommodate a syringe tube to secure the syringe, and the syringe may have a syringe flange which can then be locked between the syringe tube and the plunger rod tube. Hereby, a syringe assembly comprising the syringe, the syringe tube interconnected to the plunger tube within which the plunger rod and the plunger rod driver are positioned, can be moved as an entity. It is an advantage to lock the syringe, syringe tube and plunger rod tube together as no accidental movement of the parts relative to one another can influence drug delivery.
[0067] In one or more embodiments, the autoinjector can be a rechargeable autoinjector.
In some embodiments, the autoinjector may be configured to deliver more than one drug dose, such as two drug doses, such as a plurality of drug doses, etc., such as two separate drug doses, etc. . In some embodiments, delivery of a second or any additional doses may require an operator override input to activate the autoinjector for additional injection. The piston rod tube may comprise at least first and second locking members to allow delivery of a first and/or second dose, or the piston rod tube may comprise a plurality of locking members to enable delivery. applying a first, a second and/or a plurality of doses. Each of the first, second and/or the plurality of locking members may be configured to consecutively engage with the piston rod stop. The first, second and/or the plurality of locking members can be a first, a second and/or of the plurality of deflectable locking members. It is an advantage of the present invention that the two windows for releasing the piston rod tube are provided on the same component, i.e. on the refill handle, the manufacturing tolerances being better controllable.
[0069] The housing may comprise a first, a second and/or a plurality of openings configured to align with the first, the second and/or the plurality of locking members, respectively, when the syringe is in the second position.
[0070] It is envisaged that the opening(s) may be provided in any intermediate element, such as in a handle, positioned between the housing and the piston rod tube. Thus, the deflectable locking members can be restrained by an inner side of such an intermediate element and the opening(s) can be provided in the intermediate element only or in any intermediate element and the housing, for , for example, to allow full deflection of the locking members.
[0071] It is anticipated that the principle as presented allows any number of injections, and the autoinjector may comprise one, two and/or a plurality of sets of locking members and corresponding openings, each locking member and the corresponding opening may be provided in independent positions on the perimeter of the housing and/or any intermediate element and the piston rod tube, respectively.
[0072] It is an advantage to provide the openings in an element, such as in the housing or in an intermediate element, as substantially only the tolerances in the manufacture of an element influence the dose application control. Hereby, the first and any additional doses applied can be aligned with each other, and hereby highly controllable.
[0073] To deliver more than one dose, the autoinjector can be activated more than once, thus also the plunger rod trigger can be activated one or more times. The piston rod driver may be configured to move the piston rod a first distance upon first activation of the piston rod driver and an additional distance upon further activation of the piston rod driver.
[0074] The piston rod stop may engage the second or additional locking member after a first or additional drug injection has been performed. Thus, for example, when a first dose has been applied, the piston rod stop will engage the second deflectable locking member, and hereby be ready for the delivery of a second dose as soon as the second deflectable locking member is aligned with the second opening in the housing.
[0075] In one or more embodiments, the second activation of the piston rod driver may follow a refill of the autoinjector, and a repeated movement of the syringe and/or syringe assembly from the first position to the second position.
[0076] In one or more modalities, the user operation of the refill handle, in order, for example, to activate the autoinjector and thereby prepare the autoinjector for a second and/or additional drug application, may comprise a rotational movement .
[0077] The refill handle can be configured for a rotational movement, and the autoinjector can further comprise an intermediate component, such as a torsion ring, transferring the rotational movement of the refill handle to a transla- tional movement of fur. minus the syringe set.
[0078] The intermediate component which may be interconnected to the syringe assembly may have a tab configured to move longitudinally along a guide or surface of the refill handle to thereby withdraw the syringe assembly from the second position to the first position when user operation of the charging handle. The guide or surface of the refill handle can in some embodiments be a guide or slanted surface of the refill handle, and the tab can move along the slanted surface when operating the refill handle. Hereby, the syringe assembly can be forced along the inclined surface to move the syringe assembly from the second position to the first position, and can further rotate the syringe assembly. Hereby, the syringe assembly can follow the guide within the syringe latch to the first position.
[0079] A complete refill handle operation can force the flap over the intermediate member over a sloping surface top and into a second or additional refill handle slot. Thus, after withdrawing the syringe assembly, the syringe assembly is further rotated. This rotational movement can allow the syringe assembly to be rotated over the syringe locking edge and lock the syringe assembly into the first position and thereby prepare the device for further application. Thus, when the intermediate member tab reaches the second or additional refill handle slot, the syringe assembly is rotated over the syringe lock edge.
The second and/or any additional refill handle slots may have a sloping surface to allow for continuous recharging of the autoinjector. In one or more embodiments, the refill handle comprises two slanted refill handle slots to allow for continuous refilling of the autoinjector.
[0081] The second refill handle slit can be a substantially parallel slit with a longitudinal axis of the autoinjector, without any sloping surface top, thus the second and/or additional refill handle slit can allow longitudinal movement only to thereby prevent further recharging of the autoinjector. Thus, the refill handle may not be able to reload the autoinjector and prepare it for further injection as the intermediate component will not be able to translate the rotational movement of the handle to the translational movement of the syringe assembly.
[0082] The refill operation can be configured to reverse the operation of the autoinjector and can, for example, reverse the syringe trigger, syringe lock, skin sensor, etc.
[0083] In one or more embodiments, the injector housing may further comprise an indication of a "ready" state and a "not ready" or "done" state. The "ready" state may indicate a first rotational position of the syringe lock in which position the syringe assembly is locked in the first position. As the syringe assembly can be rotated upon injection with respect to the housing, and further moved forward with respect to the housing, the "ready" state may not be shown in the window unless the syringe assembly is in the first locked position. The "ready" state furthermore can only be indicated to an operator or patient when the skin sensor is in the unlocked state. Thus, the "ready" state can indicate that the autoinjector is ready for use when unpacked, and indicate that the autoinjector is ready for use after reloading the autoinjector.
[0084] The indication may be provided as an identification window which may reveal the information provided, for example, on the syringe latch or any other structural element under the housing in which a "ready" state is indicated, or by inscription, by color coding, etc. The indication may also be provided by being an inspection window which may be a window provided so that the drug or drug inside the syringe is visible when the auto-injector is in the ready state, and the view of the drug or drug is obscured when the autoinjector is in any "not ready" or "done" state.
[0085] The inspection window can also provide a view of the drug before the autoinjector is used for drug injection to thereby provide a visible check of drug availability, drug color, quality, etc.
[0086] The skin sensor and/or needle guard can extend over the length of the needle when the syringe assembly is in the first position to hide the needle from the view of a patient or user and the skin sensor and/or needle guard it can even be configured to extend over the length of the needle as the needle is withdrawn after a dose has been delivered.
[0087] In one or more embodiments, the autoinjector may be configured to provide a sound while delivering a drug, such that a sound is generated while dosing by, for example, a sound generator. Sound can be generated during the entire application of a dose, or sound can be generated during at least a part of the dose application, such as during more than 50% of the application time, during the last third of the application time, for substantially the entire application time, etc. Thus, the autoinjector may further comprise a sound generator configured to emit a sound while dosing, and in some embodiments, the sound generator may comprise a ratchet mechanism. The ratchet mechanism may be any conventional ratchet mechanism, such as a ratchet mechanism comprising flexible arms positioned with the syringe assembly to engage slanted teeth on the plunger rod, for example, to allow for movement to front of the piston rod only.
[0088] Typically, when applying a drug with an injector, it is advantageous to keep the needle in place under the skin for a period of time after the injection takes place. By this, drug absorption can be improved significantly, and furthermore, the risk of the drug leaking out of the injection site can be reduced. However, for a patient and user, it can be difficult to tell when the injection has been completed and thus when the time period after the injection should be determined.
[0089] In some prior art modalities, a sound is generated after the dose has been injected, that is, after the injection cycle has been completed, however, for a patient or a user, this means that there are three phases during the injection; first a silent phase as the drug is injected, then a sound phase, ie the end-of-dose signal, and then again a silent phase in which the patient or user needs to keep the needle under the skin. For a patient or user, especially a stressed user, which may be the case if this is an emergency medication injection, this can be difficult to manage.
[0090] It is therefore an advantage to generate a sound during at least a part of the dose application, to hereby indicate with a sound when the drug is injected, that is, the sound is provided while dosing, and when the sound for, the user may need to keep the needle under the skin for a period of time, this results in only two phases, a sound injection phase, and a silent phase in which the user may need to keep the needle over the skin and this procedure may be simpler to administer for a user.
[0091] To generate sound while dosing, a summing generator or noise maker, such as a ratchet mechanism, can be integrated with the autoinjector.
[0092] For example, the piston rod may be a linear ratchet that has a number of teeth configured to interact with a number of claws provided in connection with the piston rod tube, so as to generate a sound while the piston rod plunger is extended past the claws. The ratchet mechanism may comprise flexible arms positioned with the syringe assembly to engage the slanted teeth on the plunger rod.
[0093] A ratchet mechanism inherently allows movement in one direction only, so providing a ratchet mechanism with the plunger rod will allow movement in a forward direction only, and may prevent the plunger rod from being returned to its position initial. Thus, the sound generator can still act as an anti-tamper component, with the ratchet mechanism ensuring that a used autoinjector can not be separated and be refitted with another syringe for a new patient or user as the plunger rod cannot be back of the syringe to the starting position.
[0094] In one or more embodiments, the syringe assembly may further comprise an anti-tamper component, such as a tamper guard, and the anti-tamper component may, for example, comprise a guard mechanism to ensure that the rearward movement of the stem. piston is prevented, such as a ratchet mechanism, such as a ratchet mechanism that allows a forward movement of the piston rod only.
[0095] In one or more embodiments, the autoinjector can be reusable, thus a user may be able to disassemble the autoinjector to replace the syringe. For example, a user may be able to replace the syringe with the needle only, or a user may be able to replace the syringe set with a new syringe set.
[0096] Typically, the autoinjector can be fitted inside a case and the case may need to be removed before the autoinjector is ready for use.
[0097] A medical cartridge or pre-filled syringe is typically provided with a needle. In order to protect the needle during transport and to allow sharp point protection, the syringe needle is typically provided with a soft shield part and a rigid shield part, i.e. the rigid needle shield, RNS. To prepare the autoinjector for injection, typically both the soft protective part and the hard protective part need to be removed. However, both for security reasons and because the protective parts can be difficult to access for a user, a rigid needle guard removal part can be implemented. The hard needle shield removal part can at least partially surround the hard shield part and, for example, grip an edge over the hard shield part so that the hard shield part can be removed with the removal of the shield removal part of rigid needle.
The case, such as a carrying housing, can be removed, for example, by a straight pulling motion, a twist, a combination of these, or in any other way as known to a person skilled in the art. In some embodiments the case may surround the syringe assembly but not the refill handle. The holster can be held in place by a ring snap mechanism provided between the refill handle and the holster. The case and refill handle assembly can be sealed by a piece of adhesive tape wrapped around the case and refill handle assembly. The case can be removed from the autoinjector by twisting the case slightly against the refill handle, using, for example, a tuned knob on the autoinjector to translate the rotational force into a longitudinal movement which breaks, partially by rotation and partially by axial displacement in the Longitudinal direction, the ring snap mechanism. Also due to the longitudinal displacement the RNS removal part can start to pull out the RNS while the remaining disassembly of the RNS is performed by the operator. The rotational leverage on the fine-tuned knob helps the operator to more easily overcome the potential high grip forces for the RNS after a longer storage time, once moved a small distance the operator can easily pull off the RNS over the distance remaining with much less insertion force. The twisting of the refill handle in relation to the case can generate a longitudinal movement in any known way, for example, by a finely tuned knob translating the rotational force into a longitudinal movement, or by an internal thread where unscrewing in a rotational direction predetermined would generate a longitudinal separation between the handle and the case, etc.
[0099] The RNS (Rigid Needle Guard) can cover the injection needle over the syringe and can be pre-assembled over the syringe before mounting the autoinjector. The step of preparing an autoinjector for injection may comprise the step of removing the rigid needle shield whereby the injection needle becomes exposed. In some embodiments, the removal of the RNS can be an integrated part of the autoinjector device activation process and thus automated in view of the operator, user or patient. The removal part of RNS can be provided so that the autoinjector including the RNS is not tampered with during storage, and furthermore, the RNS can be protected so that any significant physical displacement from its initial sealing position of the RNS is avoided . Such physical displacement can be, for example, a radial or a longitudinal displacement or caused by oscillating movements, etc., and such physical displacement can have a serious impact on the performance of the autoinjector. The process of removing the RNS can be robust and reliable but at the same time, the seal provided by the RNS must be efficient. Thus, automated removal of the RNS upon device activation can ensure no or minimal physical interaction of external forces on the RNS during the storage period. Also, upon device activation the removal of RNS can be highly robust as it could otherwise be potentially difficult for the operator to gain access for manual removal. Thus, the mechanism that interfaces to the RNS may need to satisfy two opposite requirements. Furthermore, mounting the autoinjector with the RNS removal part can be easy and intuitive.
[00100] In some embodiments, the RNS removal portion may have a generally cylindrical shape but may have slits along its side to allow insertion of the entire RNS. Furthermore, the RNS removing part can have a U-shaped cutout on the end surface towards the syringe so as to allow the presence of the syringe, and the diameter/size of the U-shaped cutout can be designed to be smaller than the maximum diameter of the RNS but large enough not to be in physical contact during storage, ie not touching the syringe or the upper portion of the RNS. With the RNS removing part in place, a longitudinal force pulling away from the syringe will now ensure the coupling between the RNS removing part and the larger diameter edge on the RNS and can thereby force the RNS to be pulled towards out of the syringe.
[00101] The RNS removing part can be applied laterally to the RNS and syringe assembly, or the RNS removing part can be applied longitudinally, hereby pushed over the RNS and syringe assembly from the front. A number of extended hooks can grip behind the RNS to facilitate the extraction of the RNS by placing pulling forces on the removal portion of the RNS. In another embodiment, a number of extended deflectable fingers with hooks to reach behind the RNS can be provided allowing for lateral mounting as well as longitudinal or axial mounting.
[00102] In one or more embodiments, the RNS removal part can further cooperate with the skin sensor so that, for example, deflective parts, such as deflective finger hooks, can be forced into the skin sensor during removal through a tight diameter fit. For example, the skin sensor may have an inner diameter, such as 12 mm, to only allow the hooks to pass through but any potential radial deflection of the hooks, i.e. when subjected to the exerted tension of the pulling force, can be minimized due to to the available marginal space between the radially outward extension (diameter) of deflectable parts and the inner diameter of the skin sensor.
[00103] The present invention will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplary embodiments of the invention are shown. The invention may, however, be embodied in different forms and is not to be considered limited to the embodiments presented herein. Rather, these embodiments are provided so that this description will be extensive and complete, and will fully address the scope of the invention to those skilled in the art. Like reference numbers refer to like elements throughout the description. Equal elements, thus, will not be described in detail with respect to the description of each figure. BRIEF DESCRIPTION OF THE DRAWINGS
[00104] Figure 1 shows an exploded view of an autoinjector,
[00105] Figures 2A-G exemplarily show a view of the autoinjector in various states as seen from a user's perspective,
[00106] Figures 3A-C show indicators in different states,
[00107] Figures 4A-C show an injector handle top and corresponding case,
[00108] Figures 5A-E shows a rigid needle guard remover component,
[00109] Figures 6A-E show a cross-sectional view of an autoinjector according to the invention during different stages of operation,
[00110] Figures 7A-N show a refill handle, a plunger rod tube and a multistage plunger rod,
[00111] Figures 8A-C show details of a skin sensor,
[00112] Figures 9A-F show a recharging mechanism according to the present invention,
[00113] Figures 10A-E show a multi-stage syringe lock guide track,
[00114] Figures 11A-B show a detailed view of an inspection window,
[00115] Figures 12A-C show a sound generator,
[00116] Figures 13A-B show a refill handle for a single or repeated application of doses,
[00117] Figure 14 shows a syringe assembly in more detail,
[00118] Figure 15 shows another autoinjector according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE DRAWINGS
[00119] In the following an autoinjector according to any of the aspects of the invention described above will be described in more detail with reference to the drawings. A refillable autoinjector 10 with a housing 400 for accommodating a syringe assembly 20 is provided. Syringe assembly 20 may comprise a syringe 900 with a needle 902, and syringe assembly 20 may be positioned movable within housing 400 between a first position in which position the needle 902 is accommodated within housing 400 and a second position in at which position needle 902 projects out of housing 400. Syringe assembly 20 may further comprise a syringe cap 908 positioned movable within syringe 900 and sealing the contents of syringe 904, a plunger rod 1500 configured to engage the syringe cap 908, a plunger rod driver 1600 being configured to apply a force to plunger rod 1500 to advance plunger rod 1500 into syringe 900 to deliver a dose of medication. Furthermore, a syringe driver 1200 may be accommodated within housing 400 and configured to apply a force to the syringe assembly thereby moving syringe 900 from the first position to the second position. Housing 400 may further comprise a refill handle 1400 configured to refill the autoinjector 10 to inject an additional dose of medication, the refill handle 1400 may be connected to the syringe assembly so that user operation of the handle refill 1400 is configured to withdraw the syringe assembly to the first position and simultaneously reload the syringe driver 1200 to thereby prepare the autoinjector to deliver an additional dose of medication.
[00120] In Figure 1 an exploded view of a syringe driver according to an embodiment of the present invention is provided. A holster 100 is provided as a carrying case and is configured to be removed by the user before using the autoinjector 10. The rigid needle shield removal part 200 preferably cooperates with the holster 100 and the needle shield. rigid needle 300 so that the rigid needle shield can be easily removed with the case 100.
[00121] The autoinjector has a housing 400 configured to contain the additional autoinjector parts, including the syringe lock 500 and the skin sensor 600 which parts cooperate to release and lock the needle guard and syringe assembly. The 700 Skin Sensor Trigger can be a spring. The syringe tube is provided to accommodate the syringe 900 with the needle 902, and is interconnected to the plunger rod tube 1100. A sound generator 1000 is positioned between the syringe 900 and the plunger rod tube 1100. syringe driver 1200 is configured to actuate syringe 900 within syringe tube 800. A housing lock ring 1300 interconnects housing 400 and top of refill handle 1800. Handle 1400 is interconnected with top of handle 1800 and allows reloading of the device, in cooperation with syringe latch 500 and skin sensor 600 as further described below. Piston rod 1500 comprises a plurality of teeth 1502 configured to generate a sound while moving relative to sound generator 1000. Piston rod driver 1600 is configured to apply a force to piston rod 1500. A torsion ring 1700 transmits the rotational movement of the handle top to a translational movement of the syringe assembly. Handle top 1800 is positioned at one end of autoinjector 10, and is configured to be rotated with respect to housing 400 when recharging the device.
[00122] Figure 2 illustrates the autoinjector in various states of use as seen from the point of view of the user or patient. In Figure 2A, the autoinjector is contained within the holster 100 and the holster 100 is adjacent to the handle top 1800. In Figure 2B, the holster 100 is removed and the autoinjector 10 has become visible. Autoinjector 10 comprises housing 400 having an inspection window 402 and a skin sensor 600. A drug 904 within syringe 900 is visible through inspection window 402, as indicated by the dark color of the window thereby indicating a user that the autoinjector is ready to use. The top handle 1800 is configured to interact with the top handle 1400 which is partially visible below the top handle 1800 in Figure 2B. The 600 skin sensor is in a forward extended position, completely protecting the needle. In Figure 2C, the skin sensor is pushed back slightly relative to a patient's skin, and needle 902 is visible within the skin sensor opening 602. Automatic needle insertion is not yet activated. In Figure 2D, the skin sensor 600 is pushed back and is in the retracted position, and automatic needle insertion has been activated so that needle 902 protrudes from the skin sensor and the tip of syringe 900 is visible within the opening of 602 skin sensor. In this position the needle is configured to be inserted into a patient's skin. When the user removes the 902 needle from the skin after the injection, the 600 skin sensor is pushed forward and secures the 902 needle. The needle sensor is in a locked position. It is seen that in none of Figures 2C to 2E is the drug visible through the inspection window 402 thereby indicating to a user that the device is not in an initial position ready to deliver a dose. In Figure 2F, autoinjector 10 is refilled by rotating handle top 1800 with respect to housing 400, skin sensor is in an unlocked position, and medication 904 inside syringe 900 is visible through inspection window 402. Figure 2G, the skin sensor is in a locked position after a second dose has been delivered, and inspection window 402 indicates that the device is not in a ready position.
[00123] In Figure 3, indicator windows 402, 404 are provided. The 402 inspection window and the 404 identification window of the autoinjector 10 are shown in more detail. In Figure 3A the autoinjector is in a ready state with the cover and case removed. The inspection window is open and thus exposes the drug 904 within the syringe 900 and the skin sensor driver 700 is further visible through the window. It is seen that the skin sensor is in the front unlocked position and the device is ready to deliver a dose, as is also indicated by the identification window 404 which reads "READY". In Figure 3B, needle 902 was injected into the skin of a 1900 patient. The skin sensor is fully retracted and housing 400 is resting on the skin of patient 1900. The inspection window is closed and does not reveal the drug, and the identification window reads "DONE" when dose was injected. In Figure 3C, the skin sensor is fully extended and is in the front locked position and the skin sensor lock tabs 608 are visible. The inspection window is closed and the identification window still reads "DONE". It is seen that during the injection process, the 902 needle is not visible to the user or operator who activates the autoinjector and the skin sensor also acts as a needle shield or needle cover. It is seen from Figures 2 and 3 that the overall length of the autoinjector is not significantly increased when applying an additional dose and it is an advantage of the present invention that a compact autoinjector is provided which is capable of delivering one or more doses. The compact size is achieved due to the reversible characteristics of the autoinjector as further described below.
[00124] Figure 4 shows the mechanism for removing case 100 in more detail. As seen in Figure 4A the case 100 is adjacent to the handle top 1800. The case can be held in place by a ring snap mechanism in place between the handle 1400 and the case 100. The case 100 and the handle top 1800 can be sealed by a piece of adhesive tape (not shown) wrapped around the holster 100 and handle top 1800 assembly. Upon activation, ie when the user unpacks the autoinjector 10, the holster 100 is removed from the autoinjector 10 twisting it slightly against the top of handle 1800 using a tapered knob 1402 on the autoinjector, such as on the refill handle 1400 to translate the rotational force into a longitudinal movement which breaks the adhesive as shown in Figure 4B. In Figure 4B, where the case is slightly rotated to break the seal and disengage the ring snap mechanism. The case 100 is removed partially by rotation and partially by longitudinal displacement which follows both the longitudinal movement initiated by the tuned knob 1402 and a pulling action initiated by the user.
[00125] In Figure 5, RNS (Rigid Needle Guard) 300 covers injection needle 902 stacked over syringe 900 and is typically pre-assembled over syringe 900 prior to entering a device assembly line. To prepare the Autoinjector 10 for injection, the rigid needle shield needs to be removed to expose the needle. Removal of the RNS 300 is an integrated part of the autoinjector activation process and thus automated in view of the operator and user. The removal part of RNS 200 can be provided so that the autoinjector 10 including the RNS 300 is not tampered with during storage. Preferably, the RNS 300 can be secured so that any significant physical displacement from the initial sealing position of the RNS 300 is avoided. Such physical displacement could be, for example, a radial or longitudinal displacement or could be caused by oscillating movements, etc. These physical displacements could have a serious impact on the performance of the autoinjector and could, for example, bend the injection needle 902. The process of removing the RNS 300 needs to be robust and reliable but at the same time, the seal provided by the RNS 300 must be efficient. Thus, the automated removal of the RNS 300 upon activation or unpacking of the autoinjector 10 can ensure no or minimal physical interaction of forces external to the RNS 300 during the storage period. Also, upon device activation the removal of RNS can be highly robust as it could otherwise potentially be difficult for the operator to gain access for a manual removal. Thus, the mechanism that interfaces the RNS 300 must satisfy two opposite requirements. Furthermore, the assembly of the autoinjector with the removal part of RNS 200 should be easy and intuitive.
[00126] In Figure 5A, the parts are shown in detail and the removal part of RNS 200 has an overall cylindrical shape and has slots 202 along its side to allow insertion of the entire RNS 300. Further, the RNS removal part 200 has a U-shaped cutout 204 on the end surface towards the syringe 900 so as to allow the presence of the syringe 900, and the diameter/size of the U-shaped cutout 204 can be designed to be smaller than the maximum diameter of the RNS 300 but large enough not to be in physical contact during storage, ie not touching the syringe 900 or the upper portion of the RNS 300. With the RNS removal part 200 in place, a longitudinal force pulling away from the syringe will now ensure the coupling between the removal part of the RNS 200 and the larger diameter edge on the RNS 300 and can hereby force the RNS 300 to be pulled out of the syringe 900 .
[00127] The removal part of RNS 200 is in the present embodiment applied laterally with respect to the set of RNS 300 and syringe 900, and Figure 5B shows the removal part of RNS 200 applied laterally to the RNS 300. In this embodiment, the part removal of RNS 200 does not conform to the otherwise axially stacked autoinjector assembly. Figure 5C shows the syringe 900 with the RNS removing part 200 and the skin sensor 600 mounted circumferentially to the RNS removing part 200.
[00128] To benefit from the RNS removal part 200 described, a fastening between the RNS removal part 200 and the case 100 is suggested by heat stacking. In Figure 5D, a cross section of the interface between the case or cover 100 and the RNS removal part 200 is shown as assembled, the RNS removal part tip 206 is shown extending beyond the case 100. In Figure 5E, it is since heat stacking has been applied and the tip of the RNS removing part 206 has been deformed into the fixing part 208. It is, however, envisaged that any other fixing means would be possible, for example a screw or a rivet , using ultrasonic welding, etc.
[00129] Due to the attachment between the rigid RNS removal part 200 and the case 100, the RNS removal part will move when the case is moved. Thus, due to the longitudinal displacement initiated by the twisting and traction action applied to the case 100 with respect to the handle top 1800, the removal part of RNS 200 will start pulling off the RNS 300 where the remaining disassembly of the RNS 300 is performed by the operator or user. Leverage by rotation on the 1402 tuned knob helps the operator or user to more easily overcome potential high grip forces for the RNS 300 after longer storage time; since the RNS 300 has moved a small distance, the operator can easily pull the RNS 300 the remaining distance to release the 902 needle completely, with much less insertion force. It is foreseen that also another way of generating a longitudinal rotational movement can be used instead of the sharpened knob 1402, for example, by an internal thread where unscrewing in a predetermined rotational direction would generate a longitudinal separation between the handle and the case. The use of the sharpened knob 1402 has an advantage over the hidden internal features as this helps during the assembly of the autoinjector device as there is a visually clear rotational orientation for the two parts to meet.
[00130] Figure 6 shows a cross-sectional view of an autoinjector in a number of injection stages. In Figure 6A, the autoinjector is in a storage stage. The autoinjector 10 in addition to the handle top 1800 is enclosed within the case 100. The RNS 300 and the RNS 200 removal part are in position to protect the 902 needle and facilitate the removal of the RNS, respectively. Plunger rod 1500 is in a home position and a front end 1510 of plunger rod 1500 is positioned at a distance from the surface of a syringe cap 908. Hereby a slight accidental movement of plunger rod 1500 will not impact the cap of syringe 908.
[00131] In Figure 6B, the autoinjector is shown immediately after the injection of a first dose. Needle 902 is exposed and inserted into a patient's skin (not shown) and plunger rod 1500 has been moved forward under the influence of plunger rod driver, i.e. spring, 1600, so that the protrusion 1508 of the the plunger rod rests against a first stop 1102 of the plunger rod tube 1100, see further details in Figure 7. The plug 908 has been moved forward to expel a first dose of medication and the skin sensor 600 is in the rearward position.
[00132] After needle 902 has been withdrawn from the skin, in Figure 6C, the skin sensor 600 is moved to a forward locked position by the skin sensor driver 700. In stage C in Figure 6C, the autoinjector can be or discarded as-is or refilled for application of a second or additional dose.
[00133] Figure 6D shows the autoinjector 10 after recharging the device: the piston rod 1500 was moved forward under the influence of the piston rod driver, i.e., the spring 1600, so that the rod protrusion 1508 of the plunger rests against a second stop 1104 of the plunger rod tube 1100, see further details in Figure 7. The stopper 908 has been moved forward to expel a first dose of medication and the skin sensor 600 is in the rearward position.
[00134] Skin sensor 600 has been unlocked and is in the forward unlocked position, syringe driver 1200 has been reloaded, i.e. retracted, to an initial compressed position and syringe 900, syringe tube 800, rod tube of piston rod 1100, piston rod 1500 and piston rod driver 1600 have been set back without moving the mentioned parts relative to each other.
[00135] In Figure 6E, a second or additional injection was made. The piston rod 1500 has been moved forward under the influence of the piston rod driver, i.e. the spring 1600, so that the protrusion 1508 of the piston rod bears against a second stop 1104 of the piston rod tube 1100, see additional details in Figure 7. Buffer 908 was moved forward to expel a second or additional dose of drug. The skin sensor 600 is in the front locked position and the autoinjector can be discarded, an additional injection can be performed or the autoinjector can be reused, for example by refitting the autoinjector with a new pre-filled syringe.
[00136] In Figure 6 it is seen that the piston rod drive 1600 comprises a piston rod spring 1600. The piston rod spring 1600 is at one end 1602 fixedly connected to the piston rod tube 1100. the piston rod driver 1600 applies the actuating force directly over the piston rod 1500, such as over a piston rod flange 1508, i.e., the piston rod protrusion 1508. In Figure 6, it is seen that the piston rod driver acts on the top of the piston rod flange 1508 while the other side of the piston rod flange 1508 normally locks the piston rod 1500 into the piston rod tube 1100, the stopper of piston rod 1508 presses onto locking member 1108, i.e. presses onto piston rod tube stop 1102.
[00137] The housing further accommodates a syringe tube to contain the syringe, and the syringe has a syringe flange which is interlocked between the syringe tube and the plunger rod tube. In the present example, the syringe tube and the plunger tube are provided as two separate units to facilitate assembly, however, it is envisaged that the syringe tube and the plunger tube can be a tube containing the syringe, plunger rod and plunger rod actuator.
[00138] It is seen that the plunger rod driver is provided inside the plunger rod tube, and the syringe driver is provided outside the plunger rod tube.
[00139] In Figures 7A-I, a refill handle and the cooperation with the piston rod tube and the piston rod are shown. Only an upper portion 30 of an autoinjector as for example seen in any one of Figures 1-6 above or any one of the figures is seen in Figure 7. The autoinjector as shown in Figure 7 is capable of sequentially controlling needle insertion and dose injection. The function of sequential control is illustrated in stages A through L.
[00140] Figures 7A, 7C, 7E, 7G, 7I and 7K show the refill handle 1400, the piston rod tube 1100 and the piston rod 1500 at various stages of the process, and Figures 7B, 7D, 7F, 7H, 7J, and 7L show a cross-sectional view of the autoinjector at stages A, C, E, G, I, and K.
The plunger rod 1500 is configured to be advanced into the syringe (not shown in Figure 7) to deliver at least one dose of medication. Plunger rod tube 1100 has at least one locking member 1108 configured to interact with a piston rod stop 1508 to normally lock piston rod 1500 to piston rod tube 1100 (see Figures 7M, 7N). The syringe driver 1200 is not shown in Figure 7, however the activation of the syringe driver is illustrated by arrows 42, 44, i.e. the plunger rod tube 1100 and the plunger rod 1500 are both moved forward , that is, from the first position to the second position. The piston rod driver 1600 is not shown in Figure 7, however, the activation of the piston rod driver 1600 is illustrated by the single arrow 42 which illustrates that only the piston rod is moved forward, i.e., the force applied by plunger rod driver 1600 forces plunger rod 1500 forward into the syringe (not shown) to deliver at least one dose of medication. It is seen that the housing 400, or in the present case an intermediate element 1400, i.e. the refill handle 1400, comprises an opening or a hole 1420. The housing or intermediate element 1400 is configured to unlock the locking member 1108 and release the plunger rod 1500 of the plunger rod tube 1100 when the syringe (not shown) and the plunger rod tube 1100 are advanced to the second position, thereby activating the plunger rod actuator (not shown) to advance the plunger rod 1500 within the syringe for delivering at least one dose of medication.
[00142] The locking member 1108 comprises at least one deflectable member 1108 and the housing 400 and/or the intermediate member 1400 is configured to allow the at least one deflectable member 1108 to deflect away from the plunger rod 1500 when the syringe (not shown) and the piston rod tube 1100 are advanced to the second position. Thus, it is seen in Figures 7A, 7B that the plunger rod 1500 within the plunger tube tube 1100 is in an initial position, i.e. a first position, ready to deliver a dose of medication. In the second position after the forward movement of the piston rod tube 1100 and the piston rod 1500, the piston rod tube is in the second position. It is seen in Figures 7C, 7D that the piston rod 1500 has not been moved with respect to the piston rod tube 1100 and both the piston rod tube 1100 and the piston rod 1500 have been moved forward with respect to the housing or intermediate member 1400. The piston rod actuator is typically positioned within the piston rod tube 1100 circumferentially around a trailing end 1512 of the piston rod 1500 configured to apply a force to the piston rod protrusion 1508. The trailing end 1512 may have a reduced diameter, i.e. a reduced diameter relative to the diameter of other parts of the piston rod, such as, for example, relative to the front end of the piston rod 1510.
The plunger rod tube 1100 and the syringe (not shown) are typically interconnected so that the plunger rod tube 1100 cannot move with respect to the syringe 900 and vice versa. Plunger rod tube 1100 may be interconnected to syringe 900 or syringe tube 800, for example, through piston rod tube tabs 1110.
[00144] The housing has an opening 1420, the opening 1420 being a window, or an opening, configured to be aligned with the at least one deflectable member when the piston rod tube is advanced to the second position. In Figure 7D, it is seen that the first deflectable locking member 1108 is aligned with the window or opening 1420 thereby allowing the locking member 1108 to deflect and allow the passage of the piston rod protrusion 1508, such as the piston stop. 1508 piston rod.
[00145] It is seen in Figure 7E that when releasing the piston rod 1500, the piston rod driver 1600 advances the piston rod 1500 into the syringe 900 with the piston rod stop 1508 being able to pass through the member of deflected locking.
[00146] A deflectable locking member 1108, 1110 is positioned on each side of the piston rod as seen in Figure 7B, and thus also apertures 1420, 1422 are provided on each side.
[00147] In Figure 7G, the handle 1400 is rotated as illustrated by arrow 1401 and the piston rod tube 1100 with the piston rod 1500 is rotated and retracted to the same starting position as illustrated in Figure 7A, while the rod The piston rod maintains the forward position with respect to the piston rod tube, and the piston rod actuator (not shown in Figure 7) also maintains a first extended position. From this position, a second dose delivery is performed, and Figures 7I and 7J illustrate the repeated forward movement of the plunger rod tube with the plunger rod as illustrated by arrows 42, 44 so as to align the second window 1422 with the second deflectable locking member 1110 and allowing deflection of the locking member 1110. Hereby, the piston rod driver 1600 is released or activated to push the piston rod 1500 past the second locking member 1110, to deliver a second dose as illustrated by single arrow 42, and Figures 7K, 7L illustrate the plunger rod in the forward position within the syringe. The piston rod driver is thus configured to move the piston rod 1500 a first distance upon a first activation of the piston rod driver 1600, and an additional distance upon a further activation of the piston rod driver 1600.
[00148] It is seen that the second activation of the piston rod actuator follows a refill of the autoinjector, and thereby repeated movement of the syringe assembly 20, i.e., like syringe 900, syringe tube 800, rod of piston 1500, and the piston rod tube 1100 from the first position to the second position.
[00149] Thus, the autoinjector can deliver at least one or two separate doses of medication.
[00150] It is seen in Figures 7M, 7N that the piston rod stop has an inclined surface 1509 that normally presses against an angled surface 1109 of the deflectable locking member 1108. The deflectable locking member 1108, 1110 is hinged to the piston rod tube 1110 in a downward position with respect to the movement of the piston rod. Hereby, the deflectable locking member can deflect only when the entire length of the deflectable locking member 1108, 1110 opposes the full opening 14.
[00151] The at least one deflectable member is configured to deflect when being aligned with the opening in housing 400 and/or intermediate member 1400.
[00152] When the deflectable locking members 1108, 1110 are not aligned with the window 1420, the deflectable locking members 1108, 1110 are typically prevented from deflection by an inner surface 1424 of the handle 1400 or housing 400, and is seen in Figure 7N that the deflectable locking member 1108, 1110 is not entirely within the window 1420, 1422, and therefore not capable of deflecting.
[00153] The piston rod tube 1100 may thus comprise at least one first and second locking members 1108, 1110 configured to engage with the piston rod stop 1508.
[00154] Figure 8 shows the skin sensor 600 and the interaction of the skin sensor 600 with the syringe lock 500 in more detail. In Figure 8A, skin sensor 600 and syringe lock 500 are in their home positions, and skin sensor 600 is thus in the front unlocked position. A protrusion 604 that has an inclined surface 606 is seen on the skin sensor 600. In Figure 8B, the skin sensor 600 is activated, for example, by pressing the skin sensor 600 against a patient's skin, and the skin sensor 600 is moved in the direction of syringe latch 500. Thereby, sloped surface 606 couples with an inclined syringe latch surface 512 to thereby force syringe latch 500 to rotate while skin sensor 600 is retracted. In Figure 8C, the skin sensor 600 is fully depressed, that is, fully retracted, and engaged with the syringe lock after rotation. Figure 8D shows a detailed view of syringe latch protrusion 604 and sloping surface 504 of syringe latch 500.
[00155] In Figure 9, a reload mechanism is shown in more detail. In Figure 9A (the bottom of the figure), syringe 900 with needle 902 is seen protruding from syringe tube 800 at a first end, such as a front end, 804. Syringe tube 800 is coupled with stem tube of plunger rods 1100 and tabs 1110 on the front end 1101 of the plunger rod tube 1100 mate with the syringe tube 800 to interconnect the plunger rod tube 1100 and the syringe tube 800. Typically, during assembly, the syringe pre -filled 900 with the needle 902 will be inserted into the syringe tube 800 and the plunger rod tube 1100, which comprises the plunger rod 1500 and the plunger rod driver 1600, will be mounted over the syringe 900 and the plunger tube. syringe 800 and syringe lips 910 will be locked between syringe tube 800 and plunger rod tube 1100. A tab 1112 on plunger rod tube 1110 is configured to interact with syringe lock 500 (see Figure 10 for additional details). Syringe Tube 800 has an 802 Syringe Tube Inspection Window configured to interact with the 502 Syringe Latch Inspection Window and the 402 Housing Inspection Window. 600 skin and provide an initial force which must be overcome by the user when activating the autoinjector. This is an additional safety feature which reduces the risk of accidental autoinjector activation.
The refill handle 1400 is slid over the piston rod tube 1100 and the torque ring 1700 interconnects the refill handle 1400 and the piston rod tube 1100 through the torque ring tab 1702.
[00157] In Figure 9A, a first dose was applied and it is seen that the torsion ring tab 1702 is provided within a first refill handle slot 1404, and the torsion ring tab 1702 has moved forward along the slit side 1406 and is positioned at the bottom of the first refill handle slit 1404.
[00158] The refill handle 1400 as well as the torsion ring 1700 can be symmetrical so as to evenly distribute the applied force, and there is thus a torsion ring tab 1702 provided symmetrically on each side of the torsion ring, each tab of torsion ring 1702 interconnecting each of the first refill handle slots provided symmetrically around the refill handle slot.
[00159] In Figure 9B, the refill handle 1400 is rotated as indicated by arrow 1401, thereby forcing the torsion ring which cannot rotate itself, along the slanted slit side 1408 through the torsion ring tab. torsion 1702. In Figure 9B, it is seen that the torsion ring tab 1702 has moved slightly along the slanted slit side 1704 after having rotated the refill handle slightly, for example approximately 30 degrees, as seen by rotating the tapered knob. of refill handle 1402. This pulls the syringe assembly comprising syringe 900, syringe tube 800, plunger rod tube 1100, as well as plunger rod 1500 and plunger rod driver 1600 (not shown in Figure 9) back and into the 1400 refill handle as illustrated by arrow 24.
[00160] In Figure 9C, the refill handle is additionally rotated, for example, rotated 45 degrees in total, and the torque ring tab 1702 has moved towards the top edge 1410 of the first refill handle slot 1404 further back the syringe assembly 20 comprising the syringe 900, the syringe tube 800 and the plunger rod tube 1100, as well as the plunger rod 1500 and the plunger rod driver 1600 (not shown in Figure 9) to the rear and additionally into the refill handle 1400. While rotating the refill handle 1400 the plunger rod tube tabs 1112 also pivot toward a bearing edge 506 of the syringe latch 500, as seen in Figure 10.
[00161] As seen in Figure 9D, continued rotation of the refill handle 1400 lifts the torsion ring tab 1702 along with the torsion ring 1700 and syringe assembly 20 over the top edge 1410 of the first top of the refill handle 1400 and into the second refill handle slot 1414. The torsion ring 1700 including the torsion ring tab 1702 and the syringe assembly will move forward a short distance, such as a few mm, as indicated by arrow 22 before the syringe assembly 20 and more specifically the plunger rod tube tabs 1112 hang over the syringe latch bearing edge 506. The autoinjector 10 is then in the home position and ready to deliver a second or additional injection. Since the second refill handle slot is a slot that only allows movement longitudinally along a geometric axis of the autoinjector, the autoinjector is locked after having applied a second dose, and the autoinjector is thus not configured to apply more than two doses. Thus, the autoinjector cannot deliver more than two doses. Also, alternative configurations have been envisioned and are shown in further detail in Figure 13.
[00162] Figures 9E and 9F illustrate an alternative refill function in which the refill system is based on a longitudinal indentation of the syringe assembly 20, and Figure 9E illustrates the refill handle 1400 and the position of the refill ring tab. torsion 1702 after a first injection has been applied. In Figure 9F, a longitudinal indentation of syringe assembly 20 reloads the autoinjector.
[00163] Figure 10 shows a detailed view of the syringe lock guide track 504 that allows the skin sensor 600 to rotate the syringe lock 500 and control the dosing mechanism. Initially, as seen in Figure 10A, the spring loaded syringe assembly 20 rests on a syringe latch bearing edge 506 on the syringe latch 500 by the plunger rod tube tabs 1112, restricting forward movement of the assembly. syringe 20. Skin sensor 600 is in the front unlocked position.
[00164] In Figure 10B, the skin sensor is pressed against a patient's skin, and the syringe latch is rotated as indicated by arrow 24. Hereby, syringe assembly 20 is lifted free of the supporting edge of syringe lock 506.
[00165] In Figure 10C, syringe assembly 20 has moved down along syringe latch guide track 504, pushing syringe assembly 20 forward causing needle 902 to be injected. During needle injection, the latch The syringe barrel is additionally rotated to align the dosing clips with the dosing windows to allow injection of a drug. After injection, as seen in Figure 10D, and as needle 902 is withdrawn from a patient's skin, skin sensor 600 is pushed forward by skin sensor driver 700. At this point, the two skin sensor clips they are resting on a protrusion over the syringe lock, locking them in position to protect the needle. In Figure 10E, the device is reloaded and the syringe assembly 20 is in the home position, the skin sensor 600 in the forward unlocked position.
[00166] Figure 11 shows a detailed view of the inspection window 402. In Figure 11A, the housing inspection window 402, the syringe tube inspection window 802 and the syringe lock inspection window 502 are aligned and the drug 904 inside the syringe 900 is visible. Furthermore, the skin sensor driver 700 is visible through the housing inspection window 402 and the syringe lock inspection window 502. In Figure 11B, it is seen that the inspection windows are not aligned and that only a portion The syringe lock 500 is visible behind the housing inspection window indicating the device is not ready to deliver an injection dose.
[00167] It is an advantage that a user or patient is able to see the drug through inspection windows 402, 502 and 802 at the time of injection of the drug, as it gives the user a sense of what is injected.
[00168] In Figure 12 a ratchet mechanism comprising a piston rod 1500 interacting with a sound generator 1000 is shown. The sound generator 1000 comprises flexible arms 1002 positioned with the syringe assembly 20 and configured to engage the slanted teeth 1502 of the plunger rod. Upwardly angled teeth 1502 on the piston rod may allow forward movement of the piston rod only.
[00169] It is seen that the ratchet mechanism 1500, 1502, 1000, 1002 is configured to provide a sound while applying a medicine, so that a sound is generated while dosing. Slanted teeth are provided along the length of the plunger rod, and substantially along the entire length of the plunger rod so that sound is generated during application of a first dose and during application of a second dose and/or any additional doses. It is, however, foreseen that the slanted teeth can be distributed only over a part of the piston length and, for example, be configured to only generate a sound during the application of the first dose, the second dose, and additional doses or a last syringe dose of medication to indicate the end of medication in a syringe.
[00170] It is an advantage to generate a sound during at least a part of the dose application, to hereby indicate with a sound when the drug is injected, that is, the sound is provided while dosing, and when the sound stops, the user may need to keep the needle under the skin for a period of time.
[00171] The piston rod 1500 as illustrated in Figure 12 is thus a linear ratchet having a number of slanted teeth 1502 configured to interact with a number of flexible arms 1002 provided with the piston rod tube 1100 so as to engage with the piston rod 1500 when the piston rod 1500 is advanced forward past the flexible arms to thereby generate a sound.
[00172] In Figure 12A the piston rod 1500 is shown inside the piston rod tube in an initial position, ie before dosing. In Figure 12B, a first dose of drug was delivered, and plunger rod 1500 moved in a forward direction for a distance corresponding to the first dose. It is seen that there is sound delay as the plunger rod is moved from the first stop 1506 to the second stop 1504, indicating that sound only starts when the stopper 908 is moved forward and is delivering a drug. The ratchet mechanism is shown in more detail at C, where flexible arms 1002 are clearly seen to engage with slanted teeth 1502 of piston rod 1500.
[00173] As the ratchet mechanism 1500, 1502, 1000, 1002 allows movement in one direction only, the piston rod 1500 is prevented from being returned to the home position. This prevents a used autoinjector from being retrofitted with another syringe and offered to a new user. Thus, the ratchet mechanism 1500, 1502, 1000, 1002 additionally acts as a tamper-evident component.
[00174] Figure 13 shows two different reload handles in more detail. It is seen that the refill handle can be configured to allow the delivery of one, two, three, four or multiple doses. In Figure 13A, a refill handle 1400 having a refill handle slit 1412 that has two straight sides is provided, so that the refill handle slit allows longitudinal movement along a geometric axis of the autoinjector only, and hereby it does not allow rotational movement along an inclined surface. This means that only one injection is possible and that no refill function is available. It is seen that the autoinjector is in the home position with the torque ring tab 1702 on top of the refill handle slot 1404. In Figure 13B, a refill handle 1400 is shown that has a refill handle slot. 1414 which has a straight side for the injection process and a sloping side 1416 which the torsion ring tab 1702 follows when reloading. It is seen that the refill handle is provided with only two symmetrical refill handle slots 1414, and that therefore an infinite number of refills is possible as the rotation of the handle is never locked. This refill handle can, for example, be advantageous if the autoinjector is reusable and allows for retrofitting with, for example, a new syringe assembly. Any combination of the two refill handles as shown in Figure 13A and Figure 13B can provide any combination of a predetermined number of refills following the design of slot 1414 in Figure 13B, followed by a locking slot 1412 that does not allow for additional refills. The number of refill slots is primarily limited by the size of the autoinjector.
[00175] In Figure 14, a syringe assembly 20 is shown comprising syringe tube 800, syringe 900, plunger rod tube 1100, plunger rod 1500 and plunger rod driver 1600. that the parts can be assembled using various connector parts and moreover, the plunger rod tube and the syringe tube can be provided as one part. It is seen that the syringe assembly 20 can be moved with an element and/or pushed forward by the syringe driver (1200 not shown in Figure 14) acting on the syringe flange 806 and/or the piston rod flange 1114 or recoiled by a refill handle action acting on syringe assembly 20, such as syringe assembly tab 1112.
[00176] In Figure 15, another autoinjector according to an embodiment of the present invention is shown, comprising a cap or case 1, a housing 2, a skin sensor 3, a tube or syringe holder 4 and a syringe 5 which has a rigid needle guard covering the needle in the stored position (not shown), a plunger rod 6 to act on the medication within the syringe 5, a plunger rod driver, or spring motor 7, a a piston rod tube 8 comprising at least a portion of the piston rod driver 7 and the piston rod 6, and a syringe driver, such as a motor spring, 9, configured to act on at least the syringe 5, and preferably over a syringe assembly comprising the syringe tube 4, the syringe 5, the plunger rod 6, the plunger rod driver 7 and the plunger rod tube 8. needle, such as a needle guard spring 13, is configured to act on the needle guard. a/skin sensor 3. The autoinjector further comprises a refill handle 11 and a top refill handle 12.
[00177] The autoinjector 10 as unpacked is ready for use. Autoinjector 10 is applied to the injection site, which pushes needle shield 3 back a few millimeters. Hereby, the plunger rod tube acts to release the syringe driver 9 actuating the plunger rod 6, and the support or plunger rod tube 8, and hereby the syringe 5 forward resulting in the needle being inserted in the patient. When the needle is inserted, the plunger rod spring 7 is released resulting in a first dose being delivered. Plunger rod 6 moves down until it reaches a stop, which determines the dose size. Also, just before the plunger rod 6 stops, the patient is given an audible signal to signal "dose end". Injection progression can also be observed through a window. After completion of an injection, the autoinjector is raised from the injection site and the needle guard 3 is extended forward by using the needle guard spring 10 and locks in its external position where the diameter combination of Needle tip opening and distance ensure a sharp tip protection. The autoinjector is now disabled and can either be reassembled with the cap and discarded or the autoinjector can be prepared for a second injection if necessary. Thus, the autoinjector is ready to be prepared for the second injection. By turning the handle top 12, and hereby the refill handle 11, the plunger rod holder or tube 8 and the syringe holder or tube 4 are retracted back. This is done by a detail in the plunger rod holder 8 engaging a thread within the refill handle 11. When the handle has been pulled back, the plunger rod holder 8 and syringe holder 4 disable themselves. Also, when the refill handle is rotated, it unlocks the needle guard 3 from its external position, which allows the plunger rod holder 8 and syringe holder 4 to be moved forward when actuated.
[00178] When the autoinjector is applied to the injection site, the needle shield 3 is pushed back a few mm, and by this, the syringe holder 4 is configured to release the insertion spring, or syringe motor, 9, thus driving the plunger rod 6 and the syringe holder 4 forward resulting in the needle being inserted into the patient. When the needle is inserted, the injection spring, ie the plunger rod driver 7 is released resulting in a first (or second or any additional) dose being delivered. Plunger rod 6 moves down until it reaches a stop, which determines the dose size. Also, just before the plunger rod 6 stops, the patient or user is given an audible signal to signal "end of dose". Injection progression can also be observed through a window. After a second or any additional injection, needle guard 3 is pushed forward by needle guard spring 13 as needle is pushed back from the patient and needle guard 3 locks in its outer position. In addition, the refill handle 11 is also disabled, meaning the entire device is disabled and can be safely disposed of.1 cover or case2 lower housing3 needle guard4 syringe holder5 syringe with needle6 piston rod7 motor or piston rod actuator8 piston rod holder9 motor or syringe driver10 rechargeable autoinjector11 top housing or refill handle12 top of refill handle13 needle guard spring20 syringe assembly30 autoinjector top portion22, 24, 42, 44 arrows100 RNS remover case200 (needle guard) rigid)202 slot204 U-shaped cutout 206 tip of RNS removal part (rigid needle guard)208 fastening part300 RNS (rigid needle guard)400 housing402 inspection window404 identification window500 syringe latch 502 inspection window504 slot / syringe lock guide track506 syringe lock edge508 one released position510 end stop slanted surface of syringe lock 512 slanted surface of syringe lock600 skin sensor602 skin sensor opening604 bulge606 slanted surface of skin sensor700 triggering skin sensor800 syringe tube802 syringe tube sight window804 front end806 syringe tube bulges808 tube flange syringe810 syringe tube connectors900 syringe902 needle904 syringe contents (medicament)908 syringe cap910 lips1000 sound generator1002 flexible arms1100 piston rod tube1101 front end1102 first piston rod tube stop - locking member stop1104 second tube stop of piston rod 1106 end stop position 1108 first locking member1109 sloping surface of first locking member1110 piston rod tube tabs of second locking member1112 piston rod tube tab / syringe assembly tab1114 flange piston rod tube olo1116 piston rod tube connectors1118 piston rod tube rear end1200 syringe driver1300 housing lock ring1400 refill handle1401 refill handle arrow1402 tuned knob1404 refill handle first slit1406 slit side1408 slanted slit side1410 top edge of first refill handle slit1412 refill handle slit1414 second slit refill handle1420 first window1422 second window1424 inner surface 1500 piston rod1502 teeth1504 second stop1506 first stop1508 piston rod protrusion, piston rod stop1509 plunger end stop sloping surface1510 front of piston rod1512 rear end of piston rod 1600 piston rod driver1602 one end of piston rod driver1700 torsion ring1702 torsion ring tab1800 handle top1900 skin barrier

权利要求:
Claims (24)
[0001]
1. Rechargeable autoinjector with a housing (400) for accommodating structures, comprising a syringe assembly comprising a syringe (900) with a needle (902), the syringe assembly being positioned movable within the housing (400) between a first position in which position the needle (902) is accommodated within the housing (400) and a second position in which position the needle (902) projects out of the housing (400), the syringe assembly further comprising an actuator. plunger rod (1600) being configured to apply a force to the plunger rod (1500) to advance the plunger rod (1500) into the syringe (900) to deliver at least one dose of medication, a syringe driver (1200) configured to apply a force to the syringe assembly thereby moving the syringe (900) from the first position to the second position, characterized in that it comprises a refill handle (1400) configured to reload the autoinjector to inject one of the if additional medication, the refill handle (1400) being connected to the syringe assembly so that the user operation of the refill handle (1400) is configured to withdraw the syringe assembly to the first position and simultaneously reload the syringe driver (1200).
[0002]
2. Autoinjector according to claim 1, characterized in that the syringe driver (1200) and the plunger driver are separate driver means, the syringe driver (1200) comprises a resilient device such as a spring , such as a compression spring, the autoinjector further comprising a syringe lock (500) configured to lock the syringe in the first position, and a skin sensor (600) configured to release the syringe lock (500) when coupling with the skin of a user where the skin sensor (600) is activated by pressing the skin sensor (600) over a user's skin, the activation of the skin sensor (600) being configured to cause an upward movement of the skin sensor (600) whereby a skin sensor slanted surface (600) is configured to mate with a syringe latch slanted surface (500) translating the lateral movement of the skin sensor (600) in one motion s lock angle syringe (500), with the syringe assembly resting on an edge of the syringe lock (500) to lock the syringe in the first position and the angular movement of the syringe lock (500) releases the syringe assembly, whereby the syringe assembly comprises a syringe assembly tab, the syringe assembly tab being configured to move within a syringe latch guide slot (500) from a released position adjacent the edge to a syringe latch end stop. syringe (500), with the syringe assembly being moved from the first position to the second position when the syringe assembly tab moves within the syringe lock guide slot (500) from the released position to the end stop of syringe lock (500).
[0003]
3. Autoinjector according to claim 1, characterized in that the forward movement of the syringe assembly in the second position is restricted by the syringe assembly tab engaging a syringe lock end stop (500).
[0004]
4. Autoinjector according to claim 1, characterized in that a skin sensor drive (700) upon removal of the autoinjector from a user's skin is configured to push the skin sensor (600) forward to protect the needle (902) after each injection cycle, with the skin sensor (600) having a front locked position and a front unlocked position, with the skin sensor (600) being unlocked in the forward position when operating the handle. recharge (1400).
[0005]
5. Autoinjector according to claim 1, characterized in that the syringe assembly comprises a syringe tube coaxially covering the syringe and a plunger rod tube (1100) coaxially covering the plunger rod (1500), the syringe tube and the plunger rod tube (1100) being interconnected through mating syringe tube connectors with the plunger rod connectors, the plunger rod driver (1600) at one end being fixedly connected to a rear end of the piston rod tube (1100).
[0006]
6. Autoinjector according to claim 1, characterized in that the piston rod (1500) is locked while the syringe assembly is moved from the first position to the second position.
[0007]
7. Autoinjector according to claim 1, characterized in that the piston rod (1500) is configured to be released when the syringe assembly is in the second position thereby activating the piston rod driver (1600) to move piston rod (1500) forward.
[0008]
8. Autoinjector according to claim 1, characterized in that the piston rod actuator (1600) is configured to move the piston rod (1500) a first distance upon a first activation of the piston rod actuator. piston (1600), and an additional distance upon further activation of the piston rod driver (1600), with the second activation of the piston rod driver (1600) following a refill of the auto-injector, and a repeated movement of the syringe assembly from the first position to the second position.
[0009]
9. Autoinjector according to claim 1, characterized in that it has a sequential needle insertion control (902) and dose injection, the autoinjector comprising a piston rod tube (1100) having at least one locking member configured to interact with a piston rod stop (1500) to normally lock the piston rod (1500) into the piston rod tube (1100), the housing (400) being configured to unlock the piston member. locking and releasing the piston rod (1500) from the piston rod tube (1100) when the syringe assembly is advanced to the second position, thereby activating the piston rod driver (1600) to advance the piston rod (1500) into the syringe to deliver at least one dose of medication, the locking member comprising at least one deflectable member, and the housing (400) being configured to allow the at least one deflectable member to allow for deflection away. of the piston rod (1500) when the syringe and the piston rod tube (1100) are advanced to the second position, the piston rod tube (1100) and the syringe being interconnected so that the the plunger rod (1100) cannot move with respect to the syringe and vice versa, the housing (400) having an opening configured to be aligned with the at least first deflectable member when the plunger rod tube (1100) is advanced to the second position, the at least first deflectable member being configured to deflect when being aligned with the window in the housing (400), the piston rod driver (1600) comprising a piston rod spring, being that the piston rod spring at one end is fixedly connected to the piston rod tube (1100), the piston rod driver (1600) applying the actuating force directly over the piston rod, such as by over a piston rod flange.
[0010]
10. Autoinjector according to claim 9, characterized in that the housing (400) further accommodates a syringe tube to hold the syringe, and the syringe having a syringe flange is locked between the syringe tube and the piston rod tube (1100), the piston rod driver (1600) being provided inside the piston rod tube (1100), and the syringe driver (1200) being provided outside the piston rod tube (1100), an inner surface of the housing (400) preventing the at least one deflectable locking member from deflecting, and upon release of the piston rod (1500), the actuator of piston rod (1600) advances the piston rod (1500) into the syringe with the piston rod stop (1500) capable of passing through the deflected locking member, the piston rod stop (1500) having an inclined surface that normally presses against an angled surface of the locking member. the deflectable, wherein the at least one deflectable locking member is hinged to the piston rod tube (1100) in a downward position with respect to the movement of the piston rod (1500), the piston rod tube (1100) ) comprises at least a first and a second locking member configured to engage with at least a first and a second piston rod stops (1500), the housing (400) comprising at least a first and a second opening configured for aligning with the at least first and second locking members, respectively, when the syringe is in the second position.
[0011]
11. Autoinjector according to claim 1, characterized in that the autoinjector is configured to apply two or more separate doses of medicine.
[0012]
12. Autoinjector according to claim 1, characterized in that the recharge handle user operation (1400) comprises a rotational movement.
[0013]
13. Autoinjector according to claim 1, characterized in that the refill handle (1400) is configured for a rotational movement, the autoinjector further comprising an intermediate component that transfers the rotational movement of the refill handle (1400) to a translational movement of at least the syringe assembly, the intermediate member having a tab configured to move along an inclined surface of the refill handle (1400) when operating the refill handle (1400), with a complete operation of the refill handle (1400) forces the tab over a sloping surface top and into a second refill handle slot (1400), the syringe assembly being configured to rest on a syringe latch edge. (500) when the intermediate component tab hits the second handle slot, the second refill handle slot (1400) having a sloping surface to allow for continuous reloading. o for the autoinjector, the second refill handle slot (1400) allowing a longitudinal movement only to thereby prevent further refilling of the autoinjector.
[0014]
14. Autoinjector according to claim 1, characterized in that the refill operation is configured to reverse the autoinjector operation, and the refill operation is configured to reverse the syringe driver (1200), the syringe lock (500) and the skin sensor (600).
[0015]
15. Autoinjector according to claim 1, characterized in that the autoinjector housing (400) further comprises an inspection window to indicate a "ready" state and a "done" state, with the "ready" state indicating a first rotational position of the syringe lock (500) in which position the syringe assembly is locked in the first position.
[0016]
16. Autoinjector according to claim 1, characterized in that the skin sensor (600) extends over the length of the needle (902) when the syringe assembly is in the first position to hide the needle (902) from the view of a user.
[0017]
17. Autoinjector according to claim 1, characterized in that the skin sensor (600) is configured to extend over the length of the needle (902) immediately after a dose has been applied.
[0018]
18. Autoinjector according to claim 1, characterized in that the autoinjector further comprises a sound generator configured to emit a sound while dosing, the sound generator comprising a ratchet mechanism, the The ratchet comprises flexible arms positioned with the syringe assembly to engage slanted teeth on the plunger rod (1500), the ratchet mechanism allowing a forward movement of the plunger rod (1500) only.
[0019]
19. Autoinjector according to claim 1, characterized in that the syringe assembly further comprises an anti-tamper component, the anti-tamper component comprising a protective mechanism to ensure that a rearward movement of the plunger rod (1500 ) is prevented.
[0020]
20. Autoinjector according to claim 1, characterized in that the autoinjector is reusable.
[0021]
21. Autoinjector according to claim 1, characterized in that at least one dose of medicine comprises adrenaline.
[0022]
22. Autoinjector according to claim 21, characterized in that at least one of the medication comprises adrenaline.
[0023]
23. Method for operating a refillable autoinjector, the autoinjector comprising a housing (400) for accommodating a syringe assembly comprising a syringe with a needle (902), the syringe assembly being movable positioned within the housing (400) between a first position in which position the needle (902) is accommodated within the housing (400) and a second position in which position the needle (902) projects out of the housing (400), the syringe assembly further comprising a driver. the plunger rod (1600) being configured to apply a force to a plunger rod (1500) to advance the plunger rod (1500) into the syringe to deliver at least one dose of medication, the housing (400) still accommodating an actuator syringe (1200) configured to apply a force to the syringe assembly thereby moving the syringe from the first position to the second position, a skin sensor (600) for activating the autoinjector, a syringe lock (500) p to lock the syringe assembly in the first position, and a refill handle (1400), characterized by the fact that the method comprises the steps of activating the skin sensor (600) to turn the syringe lock (500) and release the syringe assembly, the syringe assembly is moved from the first position to the second position and the plunger rod driver (1600) is released to deliver a dose of medication, move the skin sensor (600) to a forward position to cover the needle (902), with the skin sensor (600) being locked in the forward position, reload the autoinjector by operating the refill handle (1400), and the syringe assembly is moved from the second position to the first position , the syringe driver (1200) is reloaded, the syringe assembly is locked in the first position, and the skin sensor (600) is unlocked.
[0024]
24. Method for operating a rechargeable autoinjector according to claim 23, characterized in that I call at least one dose of medicine comprises adrenaline.

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法律状态:
2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-10-29| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-12-29| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|

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2021-04-06| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-06-08| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 10/09/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US201161532892P| true| 2011-09-09|2011-09-09|

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US61/532,892|2011-09-09|

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PCT/IB2012/002267|WO2013034985A2|2011-09-09|2012-09-10|Reloadable auto-injector|

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