The present invention relates to an automated injection device.
Many drugs are provided in syringes (pre-filled syringes) that are manually actuated, the syringe comprising a container with a needle and a plunger rod to expel the drug. The advantages of such standard pre-filled syringes are their widespread availability and the large range of medications that may be conditioned in such syringes. However, manual actuation of a syringe is often uncomfortable or difficult for certain patients and there are also safety risks associated with the needle cap not being put back properly over the needle after use of the syringe.
In order to provide an alternative and improve the ease of administration of a liquid drug to a patient automated or auto-injection devices have become very popular. Automated injection devices often are more convenient to operate by non-trained individuals such as for example a patient. However, such automated injection devices typically include a custom medicine container that is specially adapted for the injection device. Such medicine container may be a drug containing cartridge or a syringe (for example a pre-filled syringe). Various other injection devices may receive a standard size medicine container, for example a pre-filled syringe whereby the injection device is provided with the needle and needle actuation mechanism. Such systems however have similar drawbacks as the custom medicine container devices as the injection device only accepts the particular syringe. Both such specific syringes as well as custom medicine containers are often limited to a specific manufacturer or a specific medication, and the device may not be used with the delivery of medication from different manufacturers. Further, automated injection devices that receive cartridges require a needle that may only be used once and therefore needs to be provided in a disposable part, which often requires various steps to operate the device. In addition, ensuring the sterility prior to use may also be an issue when using such injection devices. Although automated injection devices are convenient for self-injection by a patient all of the aforementioned drawbacks result in high costs and increased risk of user error.
There remains a need for auto-injection devices which are easy to use and limit the number of steps needed to operate the device. At the same time, such improved auto-injection device would reduce needle stick injury from handling the medicine container, whether it is a cartridge and needle or a pre-filled syringe for example. There further exists a need for such auto-injection device to allow for a cost-effective administration of the medicine considering the number of disposable parts in administering medicine through injection.
In view of the foregoing it would be an advantage to provide an automated injection device that is simple and safe to use and that does not rely on custom medicine container designs or is limited to a specific type of medicine container, whether this is a cartridge or a pre-filled syringe.
It is advantageous to provide an injection device that is reliable and easy to use and in particular that reduces the risk of false manipulation of the medicine container, such as a pre-filled syringe.
An object of this invention has been achieved by providing the automated injection device according to claim 1.
Another object of this invention has been achieved by providing the automated injection device according to claim 16.
Disclosed herein is an injection device comprising a housing, a syringe cradle for removably receiving a prefilled syringe having a needle, a barrel (possibly a glass barrel) with a flange, a plunger and a removable needle cap in the housing, and a system for performing automated injection comprising:
According to a first aspect of the invention, the cap actuation mechanism comprises a movable gripper for holding and releasing the needle cap and an actuator to actuate the gripping and release function and to translate the gripper and therewith the needle cap from a position aligned with the needle to a position away from the injection path of the syringe.
According to a second aspect of the invention, the plunger actuation mechanism comprises an actuator paddle coupled to an output of an actuator motor configured to displace the syringe plunger, whereby in its fully rearward position the actuator paddle engages the syringe flange clamp to pull it backwards against the force of a spring such that the syringe flange may be easily inserted in a slot of the syringe cradle with some play.
In an advantageous embodiment, the actuator of the cap actuation mechanism comprises a motor and a screw-nut linear displacement mechanism having a screw driven by the motor and engaging a nut on the gripper, the gripper being mounted on slides fixed to a support frame.
In an advantageous embodiment, the gripper comprises a slidable separator finger and gripper jaws comprising a first jaw and a second jaw that are movably mounted with respect to each other, preferably on a platform which interfaces to the gripper jaws. The first jaw further comprises a first separator finger, whereby in an ungripped position the first separator finger and the slidable separator finger abut against each other to keep the first and second jaws in a defined open position one relative to the other, and whereby the slidable separator finger is movable to disengage the separator fingers and allow the first and second jaws to move to a gripped position.
In an advantageous embodiment, the slidable separator finger is laterally slidable in a transverse direction, Td, to the injection direction to disengage the separator fingers and allow the first and second jaws to move to a gripped position.
In an advantageous embodiment, the slidable separator finger is laterally slidable between lateral shoulders on the gripper, such that a lateral shoulder of the slidable separator finger abuts against a lateral shoulder of the gripper to translate the gripper in the transverse direction when the screw-nut is actuated.
In an advantageous embodiment, the slidable separator finger comprises a nut portion that is threadably engaged by the screw of said actuator of the cap actuation mechanism.
In an advantageous embodiment, the gripper comprises a spring mounted such as to biasing the first and second jaws together.
In an advantageous embodiment, the second jaw comprises a locking shoulder that engages an end edge of the needle cap such that the needle cap is clamped or gripped between the locking shoulder and a front wall on the first jaw.
In an advantageous embodiment, the syringe actuation mechanism comprises an actuator fixed in the housing and a movable syringe support frame including a syringe cradle for lodging the syringe coupled to an output of the actuator to displace the syringe support frame relative to the housing in the injection direction.
In an advantageous embodiment, the actuator comprises a motor and a screw-nut linear displacement mechanism having a screw driven by the motor and engaging a nut connected to the syringe support frame.
In an advantageous embodiment, the syringe cradle comprises a slot to receive the syringe flange with some play between a shoulder formed on the support frame and a clamp shoulder formed on a syringe flange clamp that is movably mounted relative to the syringe support frame and the housing to clamp the syringe flange against the shoulder.
In an advantageous embodiment, the syringe flange clamp is biased by a spring towards the clamping position.
In an advantageous embodiment, the plunger actuation mechanism comprises an actuator that is fixedly mounted to the syringe support frame such that the actuator displaces in the injection direction with the movement of the syringe support frame and couples to the syringe plunger to advance the plunger in the container during administration of the liquid drug.
In an advantageous embodiment, the actuator of the plunger actuation mechanism comprises a motor and a screw-nut mechanism to accomplish the corresponding linear movements of the syringe flange clamp and of the plunger for the drug administration operation.
In an advantageous embodiment, the syringe cradle is provided with a shape that allows insertion of the syringe into a base of the housing, the shape of the cradle being configured to conform to the shape of the syringe with a certain amount of play in order to allow easy insertion of the syringe in the cradle in the correct orientation, whereby the syringe may be held within the syringe cradle by flexible clip arms. It is to be understood that the correct orientation is that orientation after insertion of the syringe into the device in which the needle and needle cap of the syringe will occupy the gripping mechanism. It is further noted that the device allows for any rotational differences along the longitudinal axis of the syringe when placing the syringe into the device resulting in the operator not having to align the flanges of the syringe a fixed position.
Further objects and advantageous features of the invention will be apparent from the claims, from the detailed description, and annexed drawings.
Referring to the figures, an injection device 2 according to an embodiment of the invention comprises a housing 3 having a base portion 3a and lid portion 3b. The base 3a comprises a syringe cradle 12 for lodging therein a syringe 1. The syringe 1 may be a standard type of syringe that is in widespread use for manual transcutaneous injection of a liquid drug. Such transcutaneous injection may include for example subcutaneous injections. The syringe 1 comprises a needle 7, a barrel 10, possibly a glass barrel, having a flange 11, a plunger 9 for pressing the liquid out through the needle, and a needle cap 8 for covering the needle when the syringe is not in use.
The syringe cradle 12 is provided with a shape that allows insertion of the syringe 1 into the base 3a, the shape of the cradle being configured to conform to the shape of the syringe with a certain amount of play in order to allow easy insertion of the syringe in the cradle in the correct orientation. In particular, given the shape, dimensions and position of the container flange 11, plunger rod and cap, there is only one orientation which the syringe 1 may be in position within the base 3a. The syringe may be held within the syringe cradle 12 by flexible clip arms 40 where the lid 3b is in an opened position to keep the syringe from falling out of the cradle before the lid is closed. A syringe ejection mechanism 47, for instance comprising one or more pivoting lever arms that engage under the syringe container 10 configured to lift the syringe out of the cradle 12 with sufficient force to overcome the flexible clip holder 40 is provided, the ejection mechanism being activated by pressing a button 27. Once a user has positioned a prefilled syringe 1 in the syringe cradle 12 and closed the lid 3b over the base 3a, a closing switch 28 which in the illustrated embodiment is in the form of a tab connected to the base. This switch 28 which may be in the form of a tab which wraps partly around the lid may provide a signal to the electronic circuit of the injection device that the lid is closed to the base. This function may be performed by many different types of sensors, for instance a proximity sensor based on magnetic, capacitive or optical sensing technology for instance or a combination thereof. An electronic circuit (not shown) within the base and/or within the lid is provided to control operation of the injection device, the injection device further comprising a power source in a form of a battery (not shown). A user interface, comprising for instance a screen, for instance provided on the inside and/or outside of the lid 3b, as well as various status indicator lights and audio output, are provided in the injection device. The user interface is configured for entering commands and providing status and information to the user, for instance to indicate the actions to be undertaken and the actions that have been completed. In addition, the device may include a docking port 46, such as for example an USB port for connecting the device either to a power supply for example to recharge or to transmit data.
The injection device 2 comprises an internal mechanism for performing automated injection of the liquid drug, which includes: removing the needle cap 8, advancing the syringe 1 such that the needle 7 extends through a needle port 26 at a skin contact face 38, advancing the plunger rod 9 by an amount corresponding to the desired injection dose, followed by withdrawing the syringe 1 and the plunger rod, such that the needle 7 enters back into the base 3b, and recapping the needle 7. The lid can then be opened and the used syringe ejected out of the cradle 12 by pressing the button 27 to actuate the ejection lever, allowing a new prefilled syringe 1 to be inserted in the syringe cradle 12 for a subsequent administration.
The internal mechanism of the injection device generally includes, for performing the aforementioned operations: a cap actuation mechanism 4 for gripping, storing and retrieving the needle cap 8, whereby advantageously removing from and replacing the needle cap 8 onto the syringe is with the aid of the syringe actuation mechanism, a syringe actuation mechanism 5 for advancing and withdrawing the syringe 1 and therewith the needle 7, and a plunger actuation mechanism 6 for advancing the plunger 9 for administration of the liquid drug.
The cap actuation mechanism comprises a gripper 13 for holding the needle cap 8 and an actuator 14a to actuate the gripping function and to translate the needle cap 8 from a position aligned with the needle 7 to a position laterally disengaged from the syringe, and its return to a position aligned with the needle after administration of the liquid drug and retraction of the syringe. Further, locking of the gripper 13 in the release/open position is also achieved by the actuator 14a.
The syringe actuation mechanism 5 comprises an actuator 14b fixedly mounted relative to a support frame 16b that is static with respect to the housing base 3a. A support frame 16c that lodges the syringe 1 is coupled to an output of the actuator 14b such that the actuator 14b of the syringe actuation mechanism 5 can displace the support frame 16c and therewith the syringe 1 relative to the housing base 3a in an injection direction Id.
The plunger actuation mechanism 6 comprises an actuator 14c that is fixedly mounted to the syringe support frame 16c such that the actuator 14c displaces in the injection direction with the movement of the syringe support frame 16c. The actuator 14c of the plunger actuation mechanism couples to the plunger 9 to advance the plunger in the container during administration of the liquid drug.
The actuators 14b, 14c of the syringe actuation mechanism 5 and plunger actuation mechanism 6 respectively, may have a construction as illustrated in
Referring now to
The syringe flange frame 33 extends from the clamp shoulder 33b rearwardly to a distal end release shoulder 33c (best seen in
As shown in
Initial operation of the injection device comprises actuating the actuator 14c of the plunger actuator mechanism in order to advance by a small amount the actuator arm 34 coupled to the actuator paddle 34a such that the syringe flange clamp 33, under the force of the spring 25 advances until it abuts the flange 11 of the syringe and clamps it against the shoulder 42 of the syringe support flange 16c. The clamping of the syringe flange 11 thus holds and positions the syringe 1 in the cradle 12 in a defined position without any play.
The plunger actuation mechanism 6 comprises the actuator 14c with the components as described in relation to the actuator of
The plunger actuator arm 34 is slidably mounted via a guide portion 34b on a slide 15c extending in the injection direction Id and fixedly mounted to the syringe support frame 16c. A position sensor 35 may be provided on the syringe support frame 16c to detect the most rearward position of the plunger actuation arm 34.
The plunger actuator arm 34 comprises a plunger actuator paddle 34a that may serve two functions, a first being to retract and release the syringe flange clamp 33 against the spring force of the spring 25 as already described above, and a second being to press the plunger 9 of the syringe 1 during the injection operation.
Referring now to
In a step subsequent to the aforementioned step, referring now to
The transverse displacement of the slideable separator finger 24b is performed by a screw 20a of a screw-nut mechanism of the actuator 14a of the cap actuation mechanism 4. The slideable separator finger 24b thus comprises a nut portion 21a that is threadably engaged by the screw 20a of the actuator 14a. Thus, for the cap gripping operation, the motor 17a of the actuator is actuated such that the slideable separator finger 24b (see
Referring to
It may be noted in this position that the syringe support frame 16c extends rearwardly beyond the end of the housing 3 which may be provided with a moveable hat 3c to allow this rearward extension during the uncapping operation as is seen in
Referring to
Referring now to
In a subsequent step as illustrated in
In the following step as illustrated in
In general, contact switches or proximity sensors may be positioned to detect the end of travel positions for each of the actuation mechanisms to stop the actuator motors once full displacement in a forward or rearward most position has occurred. The end of travel positions for each of the actuation mechanisms and to stop the respective actuator motors may also be sensed through the use of motor torque sensing through current monitoring or through sensing the number of revolutions of the actuator motor.
In a subsequent step, as illustrated in
In a subsequent step as illustrated in
Advantageously, even in the absence of needle cap 8 in the gripper jaws, the gripper jaws can be returned from a locked/closed position into a release/open position. Thus, in the absence of a syringe 1 and needle cap 8 the injection device can recover and open the gripper jaws 23a, 23b. The second gripper jaw 23b being mounted on sliders on the gripper support frame 16a allow it to move in direction Id relative to the rest of the device. The second gripper jaw 23b has an endstop 37b which is biased by spring 22 towards endstop 37a of the platform 38, which platform 38 supports the gripper jaws 23a,23b. The second gripper jaw 23b further includes a first shoulder feature (39a) whereby the syringe support frame 16c can transmit movement in direction Id to the second gripper jaw 23b, against the bias of spring 22. Further, the first and second gripper jaws each have shoulder features (39b, 39c) whereby, in the absence of a cap these shoulder features abut against each other, allowing the transmission of movement in the injection direction Id from the second gripper jaw 23b to the first gripper jaw 23a.
When the separator fingers 24a and 24b are not aligned and the first gripper jaw 23a is biased towards the second gripper jaw 23b by spring 36 in the absence of a syringe 1 and needle cap 8, the further advancement of the syringe support frame 16c in the Id direction will translate the gripper 13 into the Id direction such that the ends of the separator fingers 24a and 24b do not overlap. The cap actuation mechanism 4 can then be actuated to turn the screw 20a and displace the nut portion 21a of the slideable separator finger 24b such that the ends of the separator fingers 24a, 24b then align. Thereby recovering and opening the gripper jaws 23a, 23b following actuation of the actuator 14b of the syringe actuation mechanism 5 to reverse/withdraw the syringe support frame 16c in the injection direction Id such that the second gripper jaw 23b is biased towards the top of the gripper support frame 16a (i.e. endstop 37b of the second gripper jaw 23b is biased against endstop 37a of platform 38) through the biasing spring force of spring 22 to open the gripper jaws 23a, 23b from each other. The gripper 13 of the cap actuation mechanism 4 is thus back to its initial position.
Number | Date | Country | Kind |
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18211425.6 | Dec 2018 | EP | regional |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2019/084084 | 12/6/2019 | WO | 00 |