INJECTION DEVICE
20220016347 · 2022-01-20
Inventors
- Quentin Le Masne (Divonne les Bains, FR)
- Scott Alexander Lewis (Cambridge, GB)
- Macdara Eamonn O'SHEA (Cambridge, GB)
- Thomas Henry SHAW (Cambridge, GB)
- Douglas Edward Campbell BYATT (Cambridge, GB)
Cpc classification
A61M5/2033
HUMAN NECESSITIES
A61M5/20
HUMAN NECESSITIES
A61M5/28
HUMAN NECESSITIES
A61M5/31576
HUMAN NECESSITIES
International classification
A61M5/20
HUMAN NECESSITIES
A61M5/315
HUMAN NECESSITIES
Abstract
Injection device (2) comprising a housing (3), a syringe cradle (12) for removably receiving a syringe (1) having a needle (7), a container (10) with a flange (11), a plunger (9) and a removable needle cap (8) in the housing, and a system for performing automated injection comprising: —a cap actuation mechanism (4) for gripping, storing and retrieving the needle cap, —a syringe actuation mechanism (5) for moving the syringe in an injection direction (Id) from a position where the needle is inside the housing to an injection position where the needle projects out of a needle port of the housing on a skin contact face of the housing, and —a plunger actuation mechanism (6) for advancing the plunger for administration of the liquid drug.
Claims
1. Injection device (2) comprising a housing (3), a syringe cradle (12) for removably receiving a syringe (1) having a needle (7), a container (10) with a flange (11), a plunger (9) and a removable needle cap (8) in the housing, and a system for performing automated injection comprising: a cap actuation mechanism (4) for gripping, storing and retrieving the needle cap, a syringe actuation mechanism (5) for moving the syringe in an injection direction (Id) from a position where the needle is inside the housing to an injection position where the needle projects out of a needle port of the housing on a skin contact face of the housing, and a plunger actuation mechanism (6) for advancing the plunger for administration of the liquid drug, wherein the cap actuation mechanism comprises a movable gripper (13) for holding and releasing the needle cap and an actuator (14a) to actuate the gripping and release function and to move the gripper and therewith the needle cap from a position aligned with the needle to a position disengaged from the syringe.
2. Injection device according to claim 1 wherein the actuator (14a) comprises a motor (17a) 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 (15a) fixed to a support frame (16a).
3. Injection device according to claim 1 or 2 wherein the gripper comprises gripper jaws comprising a first jaw (23a) and a second jaw (23b) that are movably mounted with respect to each other, the first jaw having a separator finger (24a) whereby in an ungripped position the separator finger (24a) abut against a slideable separator finger (24b) to keep the first and second jaws in a defined open position one relative to the other, and whereby the slideable separator finger (24b) is movable to disengage the separator fingers and allow the first and second jaws to move to a gripped position.
4. Injection device according to the preceding claim wherein the slideable separator finger (24b) is laterally slidable in a transverse direction (Td) to the injection direction (Id) to disengage the separator fingers and allow the first and second jaws to move to a gripped position.
5. Injection device according to either of the two directly preceding claims wherein the slideable separator finger (24b) is laterally slidable between lateral shoulders (32) on the gripper, such that a lateral shoulder (31) of the slideable separator finger abuts against a lateral shoulder (32) of the gripper (13) to translate the gripper in the transverse direction (Td) when the second separator is actuated.
6. Injection device according to any of the three directly preceding claims wherein the slideable separator finger (24b) comprises a nut portion (21a) that is threadably engaged by the screw (20a) of said actuator (14a) of the cap actuation mechanism.
7. Injection device according to any preceding claim wherein the gripper comprises a spring (36) biasing the first jaw (23a) towards the second jaw (23b).
8. Injection device according to any preceding claim wherein the second jaw (23b) comprises a locking shoulder (29) that engages an end edge of the needle cap (8) such that the needle cap is clamped or gripped between the locking shoulder and a front wall (45) on the first jaw (23a).
9. Injection device according to any of preceding claim wherein the syringe actuation mechanism (5) comprises an actuator (14b) fixed in the housing and a movable syringe support frame (16c) for lodging the syringe coupled to an output of the actuator (14b) to displace the syringe support frame relative to the housing in the injection direction (Id).
10. Injection device according to the preceding claim wherein the actuator (14b) comprises a motor (17b) and a screw-nut linear displacement mechanism having a screw driven by the motor and engaging a nut connected to the syringe support frame (16c).
11. Injection device according to any preceding claim wherein the syringe cradle comprises a slot (41) to receive the syringe flange (11) with some play between a shoulder (42) formed on the support frame (16b) and a clamp shoulder (33b) formed on a syringe flange clamp (33) that is movably mounted relative to the syringe support frame (16c) and the housing to clamp the syringe flange against the shoulder.
12. Injection device according to the preceding claim wherein the syringe flange clamp (33) is biased by a spring (25) towards the clamping position.
13. Injection device according to the preceding claim wherein the plunger actuation mechanism (6) comprises an actuator paddle (34a) coupled to an output of an actuator motor (17c) configured to displace the syringe plunger, whereby in its fully rearward position the actuator paddle engages the syringe flange clamp (33) to pull it backwards against the force of the spring (25) such that the slot (41) allows the syringe flange (11) to be easily inserted in the slot with some play.
14. Injection device according to any preceding claim wherein the plunger actuation mechanism (6) comprises an actuator (14c) that is fixedly mounted to the syringe support frame (16c) such that the actuator displaces in the injection direction with the movement of the syringe support frame (16c) and couples to the syringe plunger (9) to advance the plunger in the container during administration of the liquid drug.
15. Injection device according to any preceding claim wherein 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 (33) and of the plunger (9) for the drug administration operation.
16. Injection device (2) comprising a housing (3), a syringe cradle (12) for removably receiving a syringe (1) having a needle (7), a container (10) with a flange (11), a plunger (9) and a removable needle cap (8) in the housing, and a system for performing automated injection comprising: a cap actuation mechanism (4) for gripping, storing and retrieving the needle cap, a syringe actuation mechanism (5) for moving the syringe in an injection direction (Id) from a position where the needle is inside the housing to an injection position where the needle projects out of a needle port of the housing on a skin contact face of the housing, and a plunger actuation mechanism (6) for advancing the plunger for administration of the liquid drug, wherein the syringe cradle comprises a slot (41) to receive the syringe flange (11) with some play between a shoulder (42) formed on the support frame (16b) and a clamp shoulder (33b) formed on a syringe flange clamp (33) that is movably mounted relative to a syringe support frame (16c) and the housing to clamp the syringe flange against the shoulder.
17. Injection device according to the preceding claim further comprising any one or more of the features of claims 1-10 and 12-15.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0030]
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[0046]
DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
[0047] 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.
[0048] 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.
[0049] 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.
[0050] 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.
[0051] 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.
[0052] 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.
[0053] 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.
[0054] The actuators 14b, 14c of the syringe actuation mechanism 5 and plunger actuation mechanism 6 respectively, may have a construction as illustrated in
[0055] Referring now to
[0056] The syringe flange frame 33 extends from the clamp shoulder 33b rearwardly to a distal end release shoulder 33c (best seen in
[0057] As shown in
[0058] 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.
[0059] The plunger actuation mechanism 6 comprises the actuator 14c with the components as described in relation to the actuator of
[0060] 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.
[0061] 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.
[0062] Referring now to
[0063] In a step subsequent to the aforementioned step, referring now to
[0064] 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
[0065] Referring to
[0066] 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
[0067] Referring to
[0068] Referring now to
[0069] In a subsequent step as illustrated in
[0070] In the following step as illustrated in
[0071] 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.
[0072] In a subsequent step, as illustrated in
[0073] In a subsequent step as illustrated in
[0074] 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.
[0075] 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.
TABLE-US-00001 List of references used Syringe 1 Needle 7 Needle cap 8 Plunger 9 Container 10 Flange 11 Injection device 2 Housing 3 Base 3a Syringe cradle 12 Elastic clip arms 40 Slot 41 for syringe flange Lid 3b skin contact face 38 Needle port 26 Syringe ejection mechanism button 27 Moveable hat 3c closing switch 28 syringe ejection mechanism 47 docketing port 46 support frame 16b Cap actuation mechanism 4 Gripper 13 Spring 22 gripper jaws 23 lateral shoulders 32 first jaw 23a first separator finger 24a, first jaw shoulder feature 39c front wall 45 second jaw 23b locking shoulder 29 second jaw endstop 37b second jaw shoulder features 39a, 39b platform 38 slideable separator finger 24b guide 30 lateral shoulder 31 nut portion 21a spring 36 platform endstop 37a Actuator 14a Motor 17a gears 18a Screw-nut mechanism Screw 20a Nut portion 21a Slide 15a Support frame 16a Syringe actuation mechanism 5 Actuator 14b Motor 17b Reduction gears 18b Screw-nut mechanism Screw 20b Nut 21b Slide 15b Support frame 16c shoulder 42 Syringe flange clamp 33 Clamp arm 33a Clamp shoulder 33b Distal end release shoulder 33c Guide 33d Spring 25 guide portion 43 Plunger actuation mechanism 6 Actuator 14c Motor 17c Reduction gears 18c Screw-nut mechanism Screw 20c Nut 21c Actuator arm 34 Actuator paddle 34a Guide 34b Slide 15c Support frame 16c Injection direction Id Transverse direction Td