ADMINISTRATION MECHANISM FOR A MEDICAMENT DELIVERY DEVICE
20220347393 · 2022-11-03
Inventors
Cpc classification
A61M5/31586
HUMAN NECESSITIES
A61M2005/3152
HUMAN NECESSITIES
A61M15/0028
HUMAN NECESSITIES
A61M5/20
HUMAN NECESSITIES
A61M2005/3143
HUMAN NECESSITIES
A61M2005/2013
HUMAN NECESSITIES
A61M2005/208
HUMAN NECESSITIES
A61M2005/2086
HUMAN NECESSITIES
A61M2005/31518
HUMAN NECESSITIES
A61M5/30
HUMAN NECESSITIES
A61M5/31593
HUMAN NECESSITIES
A61M5/31505
HUMAN NECESSITIES
A61M5/2033
HUMAN NECESSITIES
A61M5/31591
HUMAN NECESSITIES
A61M2005/3142
HUMAN NECESSITIES
International classification
A61M5/315
HUMAN NECESSITIES
A61M5/20
HUMAN NECESSITIES
Abstract
A medicament delivery device is presented having a proximal disposable part arranged with a body and a delivery member cover telescopically arranged in relation to the body wherein the proximal disposable part is configured to receive a medicament container. A distal reusable power pack is detachably arranged with the proximal disposable part such that the delivery member cover has an extension position in which the delivery member cover is extended in the proximal direction to cover a medicament delivery member of the medicament container, and a retraction position in which the delivery member cover is retracted in the distal direction to expose said medicament delivery member. The distal reusable power pack can have a power unit, a rotational drive unit and a plunger unit, where the rotational drive unit is powered by the power unit and is configured to move the plunger unit upon being triggered.
Claims
1-15. (canceled)
16: A medicament delivery device comprising: a proximal disposable part arranged with a body and a delivery member cover telescopically arranged in relation to the body; wherein the proximal disposable part is configured to receive a medicament container; a distal reusable power pack detachably arranged with the proximal disposable part; wherein said delivery member cover has an extension position in which the delivery member cover is extended in the proximal direction to cover a medicament delivery member of the medicament container, and a retraction position in which the delivery member cover is retracted in the distal direction to expose said medicament delivery member; wherein said distal reusable power pack comprises a power unit, a rotational drive unit and a plunger unit; wherein said rotational drive unit is powered by said power unit and is configured to move said plunger unit upon being triggered; wherein said plunger unit is configured to move a stopper of the medicament container in the proximal direction upon being moved by said rotational drive unit, so that a medicament contained in the medicament container is expelled; wherein the delivery member cover comprises a trigger configured to trigger said rotational drive unit to move said plunger unit when said delivery member cover is moved distally to the retraction position.
17: The medicament delivery device according to claim 16, wherein said power unit is a spring, the spring being configured to deliver a spring force along its circumferential direction.
18: The medicament delivery device according to claim 16, wherein said power unit is a motor.
19: The medicament delivery device according to claim 16, wherein said distal reusable power pack comprises a housing, said housing being configured to receive said rotational drive unit and said power unit, wherein said housing further comprises a locking element configured to prevent said rotational drive unit from rotating in relation to said housing in a locking position.
20: The medicament delivery device according to claim 19, wherein said trigger is configured to release said locking element to move out from the locking position, thereby triggering said rotational drive unit to move the plunger unit.
21: The medicament delivery device according to claim 18, wherein the distal reusable power pack further comprises a switch; wherein said trigger is configured to trigger said motor by switching the switch.
22: The medicament delivery device according to claim 17, wherein said distal reusable power pack further comprises a reset knob arranged to rotate the rotational drive unit against the restoring force of the spring.
23: The medicament delivery device according to claim 22, wherein the rotation of said reset knob actuates said plunger unit to move in the distal direction in relation to said proximal disposable part by the connection between the plunger unit and the rotational drive unit.
24: The medicament delivery device according to claim 18, wherein said motor is configured to reciprocate the movement of said plunger unit.
25: The medicament delivery device according to claim 16, wherein said rotational drive unit comprises a rotational gear wheel configured to rotate about an orthogonal axis of the distal reusable power pack.
26: The medicament delivery device according to claim 16, wherein said rotational drive unit comprises a drive nut configured to rotate about a longitudinal axis of the distal reusable power pack.
27: The medicament delivery device according to claim 25, wherein said plunger unit has a plurality of teeth, said plunger unit being arranged to connect with said gear wheel by means of said teeth.
28: The medicament delivery device according to claim 25, wherein said distal reusable power pack further comprises a damper gear arranged to connect to said gear wheel, said damper gear being configured to slow down the rotational speed of said gear wheel.
29: The medicament delivery device according to claim 26, wherein said plunger unit comprises a thread on its external surface.
30: The medicament delivery device according to claim 16, wherein said delivery member cover comprises a rib and said proximal disposable part comprises a rotator configured with a locking tongue, said rotator being configured to be rotated by a linear movement of the delivery member cover, wherein said rotation aligns the locking tongue with said rib, so that the delivery member cover is prevented from moving to the retraction position.
31: A medicament delivery device comprising: a proximal disposable part comprising a body and a delivery member cover axially having a longitudinal axis and movable relative to the body, wherein the proximal disposable part comprises a medicament container; and a distal reusable power pack detachably arranged with the proximal disposable part, wherein the delivery member cover has an extension position in which the delivery member cover is extended in the proximal direction to cover a medicament delivery member fixed to the medicament container, and a retraction position in which the delivery member cover is moved distally relative to the housing to expose the medicament delivery member, wherein the distal reusable power pack comprises a power unit, a rotational drive unit, and a plunger unit that moves transverse to the longitudinal axis to move a stopper within the medicament container in the proximal direction when moved by the rotational drive unit, and wherein movement of the delivery member cover to the retraction position causes the rotational drive unit to move the plunger unit.
32: The medicament delivery device of claim 31 further, wherein the delivery member cover comprises a rib and the proximal disposable part comprises a rotator, where movement of the delivery member cover to the retraction position causes the rib to engage the rotator to rotate the rotator and to activate the power unit such that rotational drive unit rotates.
33: The medicament delivery device of claim 32, wherein the rotator comprises a locking tongue that is rotated by a linear movement of the delivery member cover such that the locking tongue align with the rib when the delivery member cover has moved from the retraction position to the extension position whereby the delivery member cover is prevented from moving back to the retraction position.
34: The medicament delivery device of claim 31, wherein the plunger unit has a plurality of teeth that engage with a gear wheel fixed to the rotational drive unit such that the gear wheel rotates along an axis transverse to the longitudinal axis.
35: The medicament delivery device of claim 31 further comprising a locking element that when in a locking position prevents the rotational drive unit from rotating relative to the housing, wherein a trigger operatively associated with the delivery member cover releases the locking element from the locking position to cause the rotational drive unit to move the plunger unit.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0064] The specific embodiments of the present concept will now be described, by way of example, with reference to the accompanying drawings, in which:
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DETAILED DESCRIPTION
[0079] The present concept will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplifying embodiments are shown. The present concept may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of example so that this disclosure will be thorough and complete, and will fully convey the scope of the present concept to those skilled in the art. Like numbers refer to like elements throughout the description.
[0080]
[0081]
[0082] The distal reusable power pack 30 comprises a housing 31, a power unit 32, a rotational drive unit 33, a plunger unit 34 and a damper gear 35.
[0083] The plunger unit 34 is configured to actuate a stopper of the medicament container 40 during the medicament delivery operation, so that the stopper of the medicament container 40 is moved forward along the longitudinal axis of the medicament delivery device 10, and a medicament contained in the medicament container 40 is expelled. The rotational drive unit 33 is configured to contact the plunger unit 34 and moves the plunger unit 34 in a longitudinal direction (
[0084]
[0085] The power unit 32 is in the present example a power spring is fixed to the housing 31 at one end and fixed to the spring shaft 33c at the other end. The spring shaft 33c receives and is rotationally fixed to the central shaft 33d. The spring shaft 33c and the central shaft 33d are both rotatable and will be rotated together in relation to the housing. In an alternative embodiment, the central shaft 33d and the spring shaft 33c can be integral together as one single component.
[0086] The central shaft 33d is a central shaft of the rotational gear wheel 33a and the rotational cam ring 33b. The central shaft 33d is rotationally fixed to both the rotational gear wheel 33a and the rotational cam ring 33b; so that the rotational gear wheel 33a and the rotational cam ring 33b is configured to rotate together with the central shaft 33d and the spring shaft 33c. Since the rotational gear wheel 33a is rotationally fixed to the central shaft 33d, so once the power spring 32 is released, the spring force will rotate the spring shaft 33c, the central shaft 33d and the rotational gear wheel 32 all together; therefore, the rotational gear wheel 33a is configured to rotate about an axis X′-X″ of the distal reusable power pack 30 shown in
[0087]
[0088] The distal reusable power pack 30 also comprises a reset knob 36 fixedly connected to a reset shaft 37, shown in
[0089] The distal reusable power pack 30 further comprises a sliding pin 38 and a locking element 31a. The sliding pin 38 comprises a blocking member 38a and a sliding protrusion 38b. As illustrated in
[0090] The proximal disposable part 20 is connected to the distal reusable power pack 30 through a connection between the body 21 and the housing 31.
[0091]
[0092] Once the user is to use the medicament delivery device 10, e.g. perform the injection, he/she will firstly connect and secure the proximal disposable part 20 to the distal reusable power pack 30 and remove the protective cap (not show). The user then presses the delivery member cover 24 against the injection site. The distal end of the delivery member cover 24 comprises a distal extending structure acts as a trigger 24a, distally moving the sliding pin 38 together as the delivery member cover 24 is moved distally (
[0093] The distal movement of the sliding pin 38 causes misalignment between the blocking member 38a and the locking head 31a″, so that the flexible arm 31a′ is released to its relaxed state. The locking head 31a″ is thereby moved out of engaged with the unidirectional cam on the edge of the rotational cam ring 33b under the resilient force of the flexible arm 31a′.
[0094] Due to the disengagement between the locking element 31a and the rotational cam ring 33b, the rotational cam ring 33b is now free to rotate in relation to the housing 31. Because of the rotatable arrangement between the spring shaft 33c and the central shaft 33d in relation to the housing 31, and the rotationally fixed connection between the spring shaft 33c, the central shaft 33d, the rotational gear wheel 33a and the rotational cam ring 33b, once the rotational cam ring 33b is free to rotate in relation to the housing 31, the spring shaft 33c, the central shaft 33d, the rotational gear wheel 33a and the rotational cam ring 33b are rotated under the force of the power spring 32 along a first rotation direction.
[0095] The rotation of the rotational gear wheel 33a moves the plunger body 34a along the longitudinal axis in the proximal direction due to cooperation between the teeth and the counter teeth of the rotational gear wheel 33a and the plunger body 34a. The force of the power unit 32 is thereby able to be transmitted to and move the plunger unit 34 in the proximal direction. The plunger head 34b is able to move the stopper of the medicament container 40 forward, to eject the medicament contained in the medicament container 40.
[0096] After a predetermined dose of the medicament contained in the medicament container 40 has been ejected, the user removes the medicament delivery device 10 from the injection site, so that the delivery member cover 24 is moved proximally under the biasing force of the biasing member (not show) and covers the needle of the medicament container 40.
[0097]
[0098] The user now can remove the proximal disposable part 20 from the distal power unit 30, and reset the distal power unit 30 by firstly the user twisting the reset knob 36. The torque of the reset knob 36 causes the rotation of the reset shaft 37 along a second rotation direction, which is opposite with the first rotation direction. For example, the first rotation direction may be a clockwise direction, and the second rotation direction may then be an anti-clockwise direction. The reset shaft 37 is rotated with the spring shaft 33c and the central shaft 33d against the restoring force of the power spring 32, so that the power spring is tensioned again. The sliding pin 38 is slid back to the locking position by sliding a protrusion 38b of the sliding pin 38, so that the blocking member 38a, is aligned with the locking head 31a″ and bends the flexible arm 31a′ again. The sequence can alternatively be replaced by first sliding the sliding pin 38 back to the locking position, then twisting the reset knob 36.
[0099] Also, the rotational gear wheel 33a and the rotational cam ring 33b are rotated in the second rotation direction together with the spring shaft 33c and the central shaft 33d. The rotation of the rotational gear wheel 33a along the second rotation direction causes the distal movement of the plunger body 34a in relation to the proximal disposable part. The user may stop twisting when the spring has been fully tensed and the plunger body has been fully backed to its initial position.
[0100] The unidirectional cam on the edge of the rotational cam ring 33b is configured to engage with the locking head 31a″ in the first rotation direction, but is free to move relative to the locking head 31a″ in the second rotation direction.
[0101] Once the distal reusable power pack 30 has been fully reset and the user releases the reset knob 36, the spring shaft 33c, the central shaft 33d, the rotational gear wheel 33a and the rotational cam ring 33b will be rotated under the spring force until the unidirectional cam on the edge of the rotational cam ring 33b meets the locking head 31a″. The distal reusable power pack 30 is then in the locking position again.
[0102] The embodiment as described above is the activation mechanism for a reusable automatic medicament delivery device. However, the activation mechanism can also be used in a disposable automatic medicament delivery device. In that case, the reset knob 36 and the reset shaft 37 don't need to be included in the device arrangement.
[0103] Also, the activation mechanism can be used in an automatic medicament delivery device with a variable dose. In that case, the rotational cam ring 33b can be modified with variable unidirectional cams with different arc corresponding to variable dose selections, and the reset knob 36 can act as the dose setting knob.
[0104] The embodiment as described above discloses components for easy manufacturing. However, it can also be modified for easily assembling. For example, the spring shaft 33c and the central shaft 33d can be integral as one component, the rotational gear wheel 33a and the rotational cam ring 33b can be also integral as one component, or the spring shaft 33c, the central shaft 33d, the rotational gear wheel 33a and the rotational cam ring 33b can be integral as one component. According to one variation, the reset knob 36 and the reset shaft 37 can be integral as one component as well. Also, the trigger 24a could be an integral part of the delivery member cover 24 or a separate component attached to the delivery member cover 24, and the structure of the trigger 24a could be a rib, protrusion, recess or any other structure which is able to push the sliding pin 38 to move distally.
[0105] Also, the protrusion 38b described above can be arranged smaller/less significant for preventing the user from mistaking it for as a triggering button. The protrusion 38b could also be fully positioned in a recess of the housing 30, so that only the caregiver can reset the device or set a dose by a tool e.g. a key, for the user to inject. On the other hand, the protrusion 38b can be removed from the design, by replacing it with a spring or a biasing arm between the sliding pin 38 and the housing 31. The spring or biasing arm can be either integral as a part of housing 31 or a part of sliding pin 38 or a separate element, so that the sliding pin 38 will be biased back to the locking position and bend the flexible arm 31a′ again.
[0106]
[0107] The distal reusable power pack 130 shown in
[0108]
[0109]
[0110] The power unit 132 is a motor, configured to deliver a torque trough an output end, so that once the motor is switched on, the output end will start to rotate. The output end of the motor is a first transmission gear 133d, configured with plurality teeth. The second transmission gear 133c configured with plurality counter teeth and is configured to connect to the first transmission gear 133d through the interaction between those counter teeth and teeth of the first transmission gear 133d.
[0111] A printed circuit board (PCB) is arranged in the housing 131. The PCB comprises a switch 150, a signal unit and a processor. The switch 150 has a first switching position in which the motor 132 is configured to drive the first transmission gear 133d to rotate in a first rotation direction. The switch 150 has a second switching position in which the motor 132 is configured to drive the first transmission gear 133d to rotate in in a second rotation direction. The second rotation direction is opposite to the first rotation direction. For example, if the first rotation direction is a clockwise direction, the second rotation direction is a counter-clockwise direction.
[0112] The motor 132 has an inactive state in which the motor is not driving the first transmission gear 133d and an active state in which the motor drives the first transmission gear 133d.
[0113] Once the user uses the medicament delivery device 110, he/she will firstly connect and secure the proximal disposable part 20 to the distal reusable power pack 130, and switch on the main power of the delivery device, which for example may be done by attaching the proximal disposable part 20 or pressing a physical switch or a touch panel arranged on the housing 131. The user will then remove the protective cap (not show) and presses the delivery member cover 24 against the injection site. The distal end of the delivery member cover 24 acts as the trigger unit 24a, and switches the switch 150 by a flipping movement of the switch 150, pressing movement of the switch 150 or an electronic alignment connection in between (shown by
[0114] Once the switch 150 is in its first switching position, the motor 132 start to rotate and drive the first transmission gear 133d, so that the first transmission gear 133d is rotated in the first direction of rotation. The rotation of the first transmission gear 133d is transmitted to the second transmission gear 133c through the teeth connection between them. Due to the rotationally locked arrangement between the second transmission gear 133c, the central shaft 133b and the gear wheel 133a, the rotation of the second transmission gear 133c causes rotation of the gear wheel 133a.
[0115] The gear wheel 133a is configured to be rotated about an orthogonal axis extending along the central shaft 133b, and comprises a plurality of teeth, which are matched with counter teeth provided on the plunger body 34a so that, when the motor is driving the first transmission gear 133d in the first rotation direction, the rotation of the gear wheel 133a moves the plunger body 34a in the proximal direction. The force from the power unit 132 is thereby able to be transmitted to and move the plunger unit 34 in the proximal direction. The plunger head 34b moves the rubber stopper of the medicament container 40 in the proximal direction to expel a dose of medicament contained in the medicament container 40.
[0116] Once a predetermined dose of medicament has been fully delivered to the user, the motor 132 will be stop under the control of the processor and the processor produces a signal to the signal unit, so that the user becomes aware that the injection is completed.
[0117] The user will then remove the delivery device from the injection site, so that the delivery member cover 24 is moved in the proximal direction by the biasing member (not showed). Once the trigger unit 24a passes by the switch 150, it switches the switch 150 into the second switching position so that the motor 132 starts to drive the first transmission gear 133d in the second rotation direction. The rotation of the first transmission gear is transmitted to the second transmission gear 133c through their teeth connection, and again since the rotationally locked arrangement between the second transmission gear 133c, the central shaft 133b and the gear wheel 133a the rotation of the second transmission gear 133c causes the rotation of the gear wheel 133a.
[0118] The rotation of the gear wheel 133a causes the plunger body 34a and the plunger head 34b to be moved in the distal direction due to their teethed engagement. Once the plunger body 34a has been fully retracted to its initial position, the motor 132 is stopped again under the control of the processor, wherein the reset procedure is completed.
[0119] The plunger body 34a used in the first and the second embodiments can comprise a plurality of hingedly connected segments or a hard flexible wire with a plurality of teeth. The plunger body 34a and the plunger head 34b can be integral together as one component or two separate components hingedly connected to each other.
[0120] The embodiment as described above discloses components for easy manufacturing. However, it can also be modified under for simpler assembling. For example, the central shaft 133b and the gear wheel 133a can be integral as one component or the second transmission gear 133c, the central shaft 133b and the gear wheel 133a can be also integral as one component.
[0121]
[0122] Turning to
[0123] The plunger unit 234 is configured to actuate the stopper of the medicament container 40 during the medicament ejection step. The rotational drive unit 233 is configured to connect the plunger unit 234 and moved the plunger unit 234 along a longitudinal direction. The power unit 232 is an element accumulated with the energy configured to transit the accumulated energy to the rotational drive unit 233.
[0124] The rotational drive unit 233 comprises a drive nut 233a and an insert 233b. The insert 233b is rotationally locked to the housing 231ä. The drive nut 233a has a set of teeth on its outer surface, which are arranged to mesh with a counter set of teeth of the transmission gear 233c.
[0125] The plunger unit 234 is an elongated plunger shaft with external threads and a slot arranged on its external surface. The insert 233b comprises inner threads, which are matched with the external threads of the plunger unit 234. The drive nut 233a comprises a ridge, which is matched with the external slot of the plunger unit 234. Thereby, the plunger unit 234 and the drive nut 233a are rotationally locked together but axially movable relatively.
[0126] The distal reusable power pack 230 comprises a PCB arranged in the housing 231. The PCB comprises a first switch 250a and a second switch 250b, a signal unit and a processor. The first switch 250a has a switching on position in which the motor 232 is configured to drive the transmission gear 233c in a first rotation direction. The second switch has a switch on position in which the motor 132 is configured to drive the transmission gear 233c in a second rotation direction. The second rotation direction is opposite to the first rotation direction. For example, if the first rotation direction is rotating clockwise the second rotation direction is rotating anti-clockwise.
[0127] The motor 232 has an inactive state in which the motor does not drive the transmission gear 233c, and an active state in which the motor is driving the transmission gear 233c.
[0128] Once the user is to use the medicament delivery device 210, he/she will firstly connect and secures the proximal disposable part 20 to the distal reusable power pack 230, and switch on the main power of the delivery device, which for example may be done by attaching the proximal disposable part 20 or pressing a physical switch or a touch panel arranged on the housing 231. The user will then remove the protective cap (not show); and presses the delivery member cover 24 against the injection site. The distal end of the delivery member cover 24 acts as a trigger unit 24a and switches the first switch 250a by a flipping movement of the first switch 250a, pressing movement of the first switch 250a or an electronic alignment connection in between; so that the first switch 250a is switched into the switching on position (shown by
[0129] Once the first switch 250a is in its switching on position, the motor 232 starts to rotate and drive the transmission gear 233c in the first rotation direction, so that the transmission gear 233c is rotated about the longitudinal axis. The rotation of the transmission gear 233c is transmitted to the drive nut 233a through their teethed connection so that the drive nut 233a is rotated about an axis parallel with the said longitudinal axis.
[0130] The rotation of the drive nut 233a results in a rotation of the plunger unit 234 due to their rotationally locked engagement. Because of the thread engagement between the plunger unit 234 and the insert 233b, the plunger unit is moved by the rotational drive unit 233 in the proximal direction and moves the rubber stopper of the medicament container 40 in the proximal direction to expel a dose of medicament contained in the medicament container 40.
[0131] Once a predetermined dose of medicament has been fully delivered to the user, the motor 232 will be stop under the control of the processor and the processor generates a signal to the signal unit, so that the user becomes aware that the injection is completed.
[0132] The user will then remove the delivery device from the injection site, so that the delivery member cover 24 is moved in the proximal direction by the biasing member (not showed). Once the trigger unit 24a passes by the second switch 250b, it switches the second switch 250b into the switching on position so that the motor 232 starts to drive the transmission gear 233c in the second rotation direction.
[0133] The transmission gear 233c transmits the rotation to the drive nut 233a through their teethed connection, and again due to the rotationally locked arrangement between the drive nut 233a and the plunger unit 234 and the thread engagement between the plunger unit (234) and the insert (233b), the plunger unit (234) is moved in the distal direction. Once the plunger body 234 has been fully moved to its initial position, the motor 232 is stopped again under the control of the processor, and so the reset procedure is completed.
[0134] In an alternative embodiment, the drive nut 233a and the insert 233b are modified, such that the drive nut 233a with the inner thread surface to match with the external thread of the plunger unit 234 and rotationally arranged with the plunger unit 234. The insert 233b comprises the ridge to match with the slot on the external surface of the plunger unit 234 and is rotationally locked to the plunger unit 234 since the drive nut 233a is rotatable in relation to the plunger unit 234, but the rotation of the plunger unit 234 is limited by the ridge of the insert 233b; so that when the drive nut 233a is rotating, the plunger unit 234 is able to move in the proximal direction without rotation due to the thread engagement between the plunger unit 234 and the drive nut 233a and the ridge/slot engagement between the plunger unit 234 and the inset 233b.
[0135] The arrangements of the switch in the second and the third embodiments are interchangeable. The trigger of the injection and reset mechanism can be achieved by either one switch arrangement like described in the second embodiment or the two switches arrangement like described in the third embodiment.
[0136] The medicament container 40 can be a medicament container with an integral needle or a cartridge with a separate needle, connected to the medicament cartridge before injection. The medicament container 40 may for example only be sealed by the rubber stopper or with the rubber stopper and a plunger rod. The plunger head 34b or the plunger unit 234 disclosed in any of the embodiments can be arranged to bear against either the rubber stopper or the plunger rod.
[0137] The present concept has mainly been described above with reference to a few examples. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope of the present concept, as defined by the appended claims.