Patent Application
20220215779
The present disclosure generally relates to medicament delivery devices. In particular, it relates to drive mechanism for a medicament delivery training device and to a medicament delivery training device comprising such a drive mechanism.
Medicament delivery devices such as auto-injectors nowadays provide possibilities for the users themselves to handle medicament delivery in an easy, safe and reliable manner.
Before a user commences a drug administration programme by means of an auto-injector, it may be valuable for the user to undergo training to learn how to administer a drug properly by means of a specific auto-injector. A training device may be used for this purpose. It is known to provide a feedback mechanism for indicating to the user when the appropriate volume of medicament has been injected by the auto-injector. There are feedback mechanism that indicate the user when the injector can be removed from an injection site.
WO2018/082887 discloses a feedback mechanism for an injection device configured to deliver a medicament to a user. The feedback mechanism comprises a piston and a fluid chamber. The piston is adapted to move into the fluid chamber during use of the injection device. The feedback mechanism also has a damper arranged to damp movement of the piston. An indicator is arranged to provide feedback to the user after the piston has moved a pre-determined distance into the fluid chamber.
To conduct an exact imitation of the auto-injector functions, it is desired that the trainer is also able to produce signals for indicating the different steps in the injecting process for the user as the real auto-injectors. This will improve a training efficiency. Such feedback mechanisms can be different, produce different audio, tactical and visual signals and indicate a beginning or an end of the imitated injection process.
Furthermore, it is advantageous if the trainer device could be used a number of times for a training purpose. Therefore, it requires a possibility to be reset after a training operation for a multiple usage.
An object of the present disclosure is to provide a drive mechanism for a medicament delivery training device which solves or at least mitigates problems of the prior art.
There is hence according to a first aspect of the present disclosure provided a drive mechanism for a medicament delivery training device, the delivery mechanism comprising: a plunger rod having a proximal end and a distal end, a stopper provided on the proximal end of the plunger rod, and a container having an inner chamber, a proximal container end, and an open distal container end leading into the inner chamber, wherein the inner chamber has a distal portion and a proximal portion, wherein in an initial state of the delivery mechanism the plunger rod is axially fixedly arranged in a first position in which the stopper is arranged distally relative to the proximal portion, the plunger rod being biased towards the proximal container end, and wherein the plunger rod is configured to be released from the first position, causing the plunger rod to move towards the proximal container end and the stopper to impact with a stopper contact surface, resulting in an initial signal, and to subsequently move into the proximal portion.
A medicament delivery training device, for which the drive mechanism is designed for, may thereby simulate medicament administration of a real medicament delivery device. In particular, a user is due to the initial signal able to learn and understand when the medicament administration process is commenced during medicament administration.
The initial signal may be an initial sound such as an initial click.
According to one embodiment the stopper has an outer stopper diameter, the distal portion has a distal portion inner diameter and the proximal portion has a proximal portion inner diameter which is smaller than the distal portion inner diameter and the outer stopper diameter, the distal portion transitioning to the proximal portion via the stopper contact surface. The stopper hence impacts with the stopper contact surface because the outer stopper diameter is larger than the proximal portion inner diameter.
One embodiment comprises a holding structure provided with a radially flexible arm, wherein the plunger rod is provided with a radial recess configured to engage with the radially flexible arm to maintain the plunger rod axially fixed in the distal portion.
One embodiment comprises an actuator sleeve configured to receive the holding structure, the actuator sleeve being configured to move between a proximal position and a distal position, wherein in the proximal position the actuator sleeve is configured to urge the radially flexible arm radially inwards to engage with the radial recess.
According to one embodiment when the actuator sleeve is in the distal position the actuator sleeve is configured to enable the radially flexible arm to move radially outwards to disengage from the radial recess, thereby releasing the plunger rod from the first position.
According to one embodiment the actuator sleeve is biased towards the proximal position.
One embodiment comprises a delivery member cover configured to move linearly relative to the container, between an initial position and an activating position, wherein the delivery member cover is configured to move the actuator sleeve from the proximal position to the distal position when moved from the initial position to the activating position.
One embodiment comprises a housing configured to receive the container, wherein the housing has an inner stop structure configured to stop proximal movement of the plunger rod in the inner chamber, causing the stopper to impact with the stop structure, resulting in a subsequent signal.
The subsequent signal may be a subsequent audible sound such as a click.
A user may thereby be able to learn and understand when a medicament administration process has been finalised.
According to one embodiment the stop structure comprises a plurality of radially inwards extending protrusions.
According to one embodiment the container is provided with a proximal engagement structure configured to engage with the housing.
According to one embodiment the radially inwards extending protrusions and the proximal engagement structure are arranged to form a central proximal opening into the container.
According to one embodiment the stopper is made of a resilient material.
According to one embodiment the proximal portion inner diameter is dimensioned to cause friction between the stopper and the inner surface of the proximal portion to control a driving speed of the plunger rod.
There is according to a second aspect of the present disclosure provided a medicament delivery training device comprising a delivery mechanism according to the first aspect.
According to one embodiment the drive mechanism is configured to be actuated mechanically or electrically.
Generally, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to “a/an/the element, apparatus, component, means, etc. are to be interpreted openly as referring to at least one instance of the element, apparatus, component, means, etc.”, unless explicitly stated otherwise.
The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which:
The inventive concept will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplifying embodiments are shown. The inventive 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 inventive concept to those skilled in the art. Like numbers refer to like elements throughout the description.
In the present disclosure, when the term “distal” is used, this refers to the direction pointing away from the dose delivery site. When the term “distal part/end” is used, this refers to the part/end of the medicament delivery training device, or the parts/ends of the members thereof, which under use of the medicament delivery training device is/are located furthest away from the dose delivery site. Correspondingly, when the term “proximal” is used, this refers to the direction pointing to the dose delivery site. When the term “proximal part/end” is used, this refers to the part/end of the medicament delivery training device, or the parts/ends of the members thereof, which under use of the medicament delivery training device is/are located closest to the dose delivery site.
Further, the term “longitudinal”, with or without “axis”, refers to a direction or an axis through the device or components thereof in the direction of the longest extension of the device and/or component.
Similarly, the terms “radial”, “transversal” or “orthogonal” refers to a direction generally perpendicular to the longitudinal direction which is the axis direction and e.g. “radially or orthogonally outward” will refer to a direction pointing away for the longitudinal axis.
The medicament delivery training device 1 has a proximal end 1a and a distal end 1b. The medicament delivery training device 1 comprises a housing 3 and a cap 5. The cap 5 is configured to be removably attached to the housing 3. The cap 5 forms the proximal end 1a of the medicament delivery training device 1 when attached to the housing 3.
The medicament delivery training device 1 comprises a delivery member cover 7, and a first resilient member 9 configured to bias the delivery member cover 7 in the proximal direction. The exemplified first resilient member 9 may be a spring. The delivery member cover 7 is configured to be received by the housing 3. The delivery member cover 7 is configured to be moved linearly relative to the housing 3, between an initial position and an activation position. The delivery member cover 7 extends more in the proximal direction from the housing 3 in the initial position than in the activation position. Hereto, the initial position is an extended position and the activation position is a retracted position relative to the housing 3. The first resilient member 9 is configured to bias the delivery member cover 7 towards the initial position, i.e. the extended position.
The medicament delivery training device 1 comprises a container 11. The container 11 is a syringe dummy. Since it is the syringe dummy, the exemplified container 11 does not comprise any needle or canula. The container 11 has an inner chamber 11a. The inner chamber 11a extends through the container 11. The container 11 has an open distal container end 11b. The container 11 has an open proximal container end 11c. The inner chamber 11a extends between the open distal container end 11b and the open proximal container end 11c.
The medicament delivery training device 1 comprises a plunger rod 13. The plunger rod 13 is provided with a stopper 15. The stopper 15 is provided on a proximal end of the plunger rod 13. The stopper 15 may be made of an elastic, resilient or flexible material.
The plunger rod 13 may have a proximal end face or cap/cover which may form part of the stopper 15 or which may extend in the proximal direction from the stopper 15. The proximal end face of the plunger rod 13 may be made of a rigid material such as a plastic material or a metal. In examples in which the plunger rod has a proximal end face, the proximal end face and the elastic stopper body together form the stopper as defined herein.
The plunger rod 13, the stopper 15 and the container 11 forms part of a drive mechanism of the medicament delivery training device 1.
The container 11 is configured to receive the plunger rod 13. The plunger rod 13 is configured to extend in the proximal direction into the inner chamber 11a through the open distal container end 11b.
The exemplified plunger rod 13 comprises a recess 13a. The recess 13a is a radial recess. In the example shown in
The medicament delivery training device 1 comprises a second resilient member 17 configured to bias the plunger rod 13 in the proximal direction. The second resilient member 17 may be a spring. The second resilient member 17 is configured to be received by the plunger rod 13. The plunger rod 13 may hence be hollow.
The medicament delivery training device 1 comprises a holding structure 21. The holding structure 21 is configured to be received by the housing 3. The holding structure 21 is configured to be fixedly arranged in the housing 3. The holding structure 21 is axially fixed relative to the housing 3. The holding structure 21 is arranged in a distal portion of the housing 3. The holding structure 21 is an elongated structure. The holding structure 21 is hollow. The holding structure 21 is configured to receive a distal end portion 13b of the plunger rod 13.
The holding structure 21 comprises a plurality of radially flexible arms 21a. The radially flexible arms 21a extend in the proximal direction. The radially flexible arms 21a form a proximal end of the holding structure 21. Each radially flexible arm 21a is configured to engage with the recess 13a of the plunger rod 13. Each radially flexible arm 21a comprises a radially inwards extending protrusion configured to engage with the recess 13a.
The medicament delivery training device 1 comprises an actuator sleeve 19. The actuator sleeve 19 is configured to be arranged around a proximal portion of the holding structure 21. The actuator sleeve 19 is configured to be moved linearly relative to the holding structure 21 between a proximal position and a distal position. The delivery member cover 7 is configured to move the actuator sleeve 19 from the proximal position to the distal position. When the delivery member cover 7 is in the initial position, the actuator sleeve 19 is arranged in the proximal position. When the delivery member cover 7 is moved in the distal direction towards the activation position, the actuation sleeve 19 is moved towards the distal position. The actuator sleeve 19 has a proximal flange 19a. The delivery member cover 7 has distally extending legs configured to bear against/engage with the proximal flange 19a when the delivery member cover 7 is moved towards the activation position. The actuation sleeve 19 is thereby moved towards the distal position as the delivery member cover 7 is moved in the distal direction.
The actuator sleeve 19 is configured to be arranged around the radially flexible arms 21a and urge the radially flexible arms 21a to engage with the recess 13a of the plunger rod 13 when the actuator sleeve 19 is in the proximal position.
The medicament delivery training device 1 comprises a third resilient member 23. The third resilient member 23 may be a spring. The third resilient member 23 is configured to bias the actuator sleeve 19 in the proximal direction towards the proximal position. The holding member 21 has a distal flange surface 21b. The third resilient member 23 is configured to be arranged between the distal end of the proximal flange 19a of the actuator sleeve 19 and the distal flange surface 21b. The third resilient member 23 thereby biases the actuator sleeve 19 in the proximal direction towards the proximal position.
The open distal container end 11b opens into the distal portion 11i. The distal portion 11i transitions to the proximal portion 11h via a stopper contact surface 11j. The stopper contact surface 11j may for example be inclined relative to the central longitudinal axis of the container 11, as shown in
The outer stopper diameter may for example be defined by the largest outer dimension or diameter of the stopper 15. The proximal portion inner diameter d1 is smaller than the outer stopper diameter. The proximal portion inner diameter d1 is dimensioned to provide friction onto the stopper 15 to control the driving speed of the plunger rod 13. The driving speed should preferably simulate the driving speed of the plunger rod of the corresponding real medicament delivery device which the medicament delivery training device 1 is designed to simulate.
The actuator sleeve 19 is arranged in the proximal position as it is biased by the third resilient member 23 in the proximal direction and the delivery member cover 7 is in the initial position in which it does not apply any, or at least negligible force in the distal direction onto the actuator sleeve 19. The radially flexible arms 21a are hence urged radially inwards by the actuator sleeve 19 which is arranged around the radially flexible arms 21a. The radially flexible arms 21a thereby engage with the recess 13a. The plunger rod 13 is therefore maintained in a first position in which it extends through the open distal container end 11b and the stopper 15 is arranged fixed in the distal portion 11i of the container 11. The proximal end of the stopper 15 is typically arranged at a distance from the stopper contact surface 11j.
When a user is to perform training with the medicament delivery training device 1, the cap 5 is first to be removed from the housing 3. This is shown in
In
In
In
In
In this used state of the medicament delivery training device 1, the medicament delivery training device 1 may be reset manually for further training. The plunger rod 13 may in particular be reset to the first position.
This resetting may be performed by manually inserting the resetting structure 5a. In particular, the resetting may be performed manually by a user placing the cap 5 back onto the housing 3.
The inventive 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 inventive concept, as defined by the appended claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 19182613.0 | Jun 2019 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2020/065851 | 6/8/2020 | WO | 00 |
