Patent Application
20190259303
The present invention relates to an orientation indicator for a medicament delivery device, and more particularly to an orientation indicator for informing a user of a medicament delivery device that a proper orientation of the device is attained.
The development of medicament delivery devices has become more and more directed towards self-medication, i.e. to let the patient administer a medicament to him- or herself in an easy, safe and reliable way. There are different types of medicaments that can be stored for a long time and that are packaged in cartridges or the like, containing a ready-to-use medicament in liquid state. There are also other types of medicaments that are stored in separate compartments. An agent (e.g. lyophilized, powdered or concentrated liquid) is stored in one compartment of the container, and a diluent (e.g. water, dextrox solution or saline solution) is stored in a separate compartment. These types of medicaments cannot be pre-mixed and stored for a long time because the medicament agent is unstable and can be degraded and will lose its effect quickly. Hence, the patients have to perform the mixing shortly before administration. During the mixing step, a significant amount of air needs to be evacuated from the powder compartment as it is filled with diluent. This air needs to escape through a delivery member, e.g. a needle, a mouthpiece or a nozzle, of the device. At the same time it is important not to spill any of the liquid medicament during the mixing procedure.
Other types of delivery devices comprise a container with a pre-mixed solution. Still, some air may need to be evacuated before use. The device needs to be “primed”.
Priming is necessary to avoid injecting air into the bloodstream and to make sure that a correct dosage is administrated.
In both types of delivery devices, the devices must be oriented with its delivery member pointing upwards. Conventionally, air is evacuated by the patient tapping the device with a finger, to make sure that any air in the container is collected at the top, near the opening of the container. Thereafter, the container is pressurized, such as by pushing the piston rod forward, until some of the liquid medicament appears at an opening of the delivery member, e.g. at the tip of an injection needle. The patient therefore needs to be taught and trained on how to handle the medicament delivery device before usage.
There are a number of prior art devices that register patient handling of medicament delivery devices. One example is US2015/0246179, wherein sensors are used to detect the progress of an injection process, such as temperature, dosage and orientation. A controller determines the progress and provides a notification thereof, both directly, by beeping, and indirectly, by sending data to a smartphone app.
The disclosed solution is unnecessarily complicated for many applications. The present invention provides a simple and robust orientation indicator that is also reliable and easy to use.
An object of the present invention is to provide an orientation indicator for a medicament delivery device, wherein the drawbacks of the state of the art devices are remedied.
In the present application, 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 delivery device, or the parts/ends of the members thereof, which under use of the medicament delivery 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 delivery device, or the parts/ends of the members thereof, which under use of the medicament delivery 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 or the component.
The term “lateral”, with or without “axis”, refers to a direction or an axis through the device or components thereof in the direction of the broadest extension of the device or the component.
In a similar manner, the terms “radial” or “transversal”, with or without “axis”, refers to a direction or an axis through the device or components thereof in a direction generally perpendicular to the longitudinal direction, e.g. “radially outward” would refer to a direction pointing away from the longitudinal axis.
Also, if nothing else is stated, in the following description wherein the mechanical structure of the device and the mechanical interconnection of its components is described, the device is in an initial non-activated or non-operated state.
As stated above, the aim of the present invention is to provide a simple and robust orientation indicator that is also reliable and easy to use.
According to a main aspect of the invention it is characterized by the features of the independent patent claim. Further advantageous features are the subject of the dependent claims.
According to a main aspect of the invention it is characterised by an orientation indicator for a medicament delivery device, which orientation indicator comprises a support element having a proximal end and a distal end, an activation member, movable, in relation to the support element, between a first position and a second position, an electrical circuit comprising a signal switch, and a signalling element connected to the electrical circuit, wherein the activation member may move under gravitational force when the support element is tilted to actuate the signal switch, such that a signal may be generated by the signalling element.
A movable element, which moves under the influence of gravity, is a robust and simple solution. The element may slide, roll, pivot or fall between the first and the second positions, as long as it is able to interact with, i.e. to close, or to open, the signal switch.
According to another aspect of the invention the activation member is made of a conductive material, such that actuation of the signal switch, by the activation member, closes or opens the signal switch.
Conductivity is a further advantage in that the movable element may directly close or open the electrical circuit by bridging or opening the gap between the poles of the signal switch. No additional mechanical or electrical component needs to be involved in actuating the switch.
According to another aspect of the invention the activation member is slidably movable between the first position and the second position.
A slidable activation member may have any suitable shape and may be formed to provide a small contact surface with a substrate on which it slides. The slidable activation member may be made of a material that provides a low coefficient of friction with the substrate on which it slides.
According to another aspect of the invention the activation member is rollably movable between the first position and the second position.
A rollable activation member may be ball-shaped, cylindrical, or have any other shape that allows a rolling motion.
According to another aspect of the invention the activation member is a ball and wherein the ball and the signal switch constitute a tilt ball switch.
According to another aspect of the invention the activation member is made of a liquid conductor.
According to another aspect of the invention the liquid conductor is mercury and wherein the liquid conductor and the signal switch constitute a mercury switch.
Mercury switches are generally known in other fields of technology. Nowadays, however, mercury is often avoided due to its poisonous and environmentally polluting properties.
According to another aspect of the invention the activation member is held fixed in the first position until released by a manually operable locking member.
During normal handling of a medicament delivery device, the device is often tilted in various directions. In order to avoid activating the signalling element, the activation member may be held fixed in the first position until it is time to use the device. The manually operable locking member may be of any configuration known in the art. It may be operated by pushing or sliding a button, turning a knob, etc.
According to another aspect of the invention the electrical circuit further comprises a manually operable second switch, and wherein the signal is generated by the signalling element when the signal switch and the second switch are actuated.
In a similar fashion to the manually operable locking member, the second switch serves to prevent the signalling element from being activated prematurely, i.e. to prevent the signalling device from activating accidentally before the device is to be used. The second switch may be opened or closed to set the electrical circuit in an active state, before or after the signal switch is actuated. The second switch may be actuated by turning a knob, operating a button, etc.
According to another aspect of the invention the signal generated by the signalling element is an audible signal and/or a tactile signal and/or a visual signal.
The signalling element may display a visible light, or a colour, or a symbol, or the like.
The signalling element may generate a sound, which may sound positive or negative, depending on the orientation in which the electrical circuit and the signalling element are designed to be activated.
The signalling element may generate a tactile sensation, such as a vibration, which is distributed in the device in which the orientation indicator is arranged.
According to another aspect of the invention the second position is located proximally, relative to the first position, such that a negative signal is generated by the signalling element, indicating an incorrect orientation.
The activation member moves under the influence of gravity. Therefore, if the second position is proximal of the first position it means that the signalling element is activated when the proximal part of the orientation indicator is lower than the distal part, meaning that a negative signal will be generated. A negative signal may for instance be a red light, a dissonant noise or an unpleasant vibration.
According to another aspect of the invention the second position is located distally, relative to the first position, such that a positive signal is generated by the signalling element, indicating a correct orientation.
As opposed to the situation above, if the second position is distal of the first position it means that the signalling element is activated when the proximal part of the orientation indicator is higher than the distal part, meaning that a positive signal will be generated. A positive signal may for instance be a green light, a harmonic melody or a soft vibration.
According to another aspect of the invention the support element is attachable to a medicament delivery device.
The orientation indicator may be designed as a packaged module that may be attached to an outer part of a medicament delivery device. In this way, the orientation indicator may be used for many types of medicament delivery devices, which do not need to be further adapted to accommodate the orientation indicator.
According to another aspect of the invention the support element is integrated in a medicament delivery device.
By integrating the orientation indicator in a medicament delivery device, a more compact design may be achieved. The orientation indicator may thereby be arranged on the inside of the device, such that visual signals may be viewed through a window.
According to another aspect of the invention the electrical circuit also comprises a control unit and a communication unit capable of wirelessly communicating orientation data with an external device, which orientation data is retrieved from the control unit.
A further aspect of the invention relates to a medicament delivery device comprising an orientation indicator according to any of the previous aspects of the invention.
These and other features and advantages of the present invention will become apparent from the following detailed description and the drawings.
The figures below disclose an embodiment of the invention for illustrational purposes only. In particular, the disclosure within the figures is not meant to limit the range of protection of the invention. The embodiment shown may be modified in different ways within the scope of the claims.
The support element 20 of the orientation indicator may be integrated in a medicament delivery device as shown in
The support element 20 comprises an electrical circuit 28 (
When integrated in a medicament delivery device 10, the support element 20 may be generally regarded as comprised in a body of the medicament delivery device 10. Accordingly, the various components comprised by the support element 20 may be distributed throughout the medicament delivery device, as appropriate, to be properly adapted to the various functions and features of both the medicament delivery device 10 and of the orientation indicator.
By integrating the orientation indicator in a medicament delivery device, a more compact design may be achieved. The orientation indicator may thereby be arranged on the inside of the device, such that visual signals may be viewed through a window.
An advantage of the orientation indicator as a separate module is that it may be used for most kinds of already existing medicament delivery devices.
The activation member 22 is preferably made of a conductive material, e.g. metal, such that actuation of the signal switch 29, by the activation member 22, closes the signal switch such that an electrical current from the power source 24 activates the signalling element 26. In an alternative embodiment the electrical circuit may be designed such that the signal switch 29 is opened by movement of the activation member 22, whereby the signalling element 26 is activated by
Using conductivity as an activating means is advantageous in that the movable element may in itself directly close or open the electrical circuit by bridging or opening the gap between the poles of the signal switch. No additional mechanical or electrical component needs to be involved in activating the switch.
The activation member 22 may be designed in different ways to achieve the preferred characteristics, e.g. speed of movement, friction, etc. The activation member 22 may be slidably movable between the first position and the second position. A sliding motion is relatively slow and needs a certain tilting angle to overcome the friction between the activation member 22 a sliding surface of the support element 20.
The slidable activation member may have any suitable shape and may be formed to provide a large or a small contact surface with the sliding substrate on which it slides. The slidable activation member may be made of a material that provides a required coefficient of friction with the substrate on which it slides.
The activation member may alternatively be rollably movable between the first position and the second position. A rollable activation member 22 may be ball-shaped, cylindrical, or have any other shape that allows a rolling motion. Friction is negligible and movement may be initiated by only a small tilt of the orientation indicator.
In the illustrated embodiment, the activation member 22 is a ball, and the ball and the signal switch 29 may constitute a tilt ball switch.
The activation member 22 may be a liquid conductor. The liquid conductor may be mercury, and the liquid conductor and the signal switch 29 may constitute a mercury switch.
Mercury switches are generally known in other fields of technology. Nowadays, however, mercury is often avoided due to its poisonous and environmentally polluting properties. However, other liquid conductors are also conceivable.
The activation member 22 may be held fixed in the first position until released by a manually operable locking member 30. During normal handling of a medicament delivery device, the device is often tilted in various directions, which might cause the orientation indicator to accidentally generate signals. In order to avoid activating the signalling element, the activation member may therefore be held fixed in the first position until it is time to use the device. The manually operable locking member may be of any configuration known in the art. It may be operated by pushing or sliding a button, or turning a knob, etc. As illustrated in the figures, the manually operable locking member 30 may be moved between a locking position in which the activation member 22 is prevented from moving, and a released position in which the activation member 22 is released for movement. In the figures, the locking position is marked “0” and the released position is marked “I”. The locking mechanism that fixes the activation member 22 may be selected from any suitable locking mechanism known to the skilled person.
Alternatively, the electrical circuit may comprise a manually operable second switch, and wherein the signal is generated by the signalling element 26 when both the signal switch 29 and the second switch 60 are actuated.
In a similar fashion to the manually operable locking member 30, the second switch 60 serves to prevent the signalling element 26 from being activated prematurely, i.e. to prevent the signalling element 26 from accidental activation before the device is to be used. The second switch 60 may be opened or closed to set the electrical circuit in an active state, before or after the signal switch 29 is actuated. The second switch 60 may be actuated by turning a knob, operating a button, etc. The second switch 60 shown in
The signal generated by the signalling element 26 may be an audible signal, a tactile signal or a visual signal. The generated signal may also be a combination of those. The visual signal may be visible light, or a colour, or a symbol, or the like. The tactile signal may be a tactile sensation, such as a vibration, which is distributed from the support element 22, throughout the device in which the orientation indicator is arranged.
The signal generated by the signalling element 26 may be designed to be perceived as either positive or negative, depending on the orientation in which the electrical circuit and the signalling element are designed to be activated. A light may be green (positive) or red (negative). A sound may be harmonious (positive) or dissonant (negative). A tactile signal may be soft (positive) or hard and intense (negative).
A correct orientation of a medicament delivery device, comprising the orientation indicator, during a mixing or a priming operation is to have the delivery member 50 pointing upwards from a horizontal plane. Consequently, the orientation indicator must be configured to signal either a good orientation or a bad orientation. The electrical circuit may also be configured to activate the signalling element 26 when the activation member 22, moving under the force of gravity, either closes or opens the signal switch 29. As explained earlier, the signal switch 29 is located at the second position of the activation member 22. Thus, four configurations are conceivable:
When the user sets the second switch 60 to the active position “1” (
The electrical circuits that provide the above-described functions are readily available to the skilled person and do not require any further explanation, except to note that in case of activation by opening a switch, a detection circuit may need to be provided as part of the electrical circuit, in order to detect the opening of the switch and to at least partly activate the signalling element 26.
With information technology, it is also conceivable to configure the electrical circuit to also comprise a control unit and a communication unit capable of wirelessly communicating orientation data with an external device, which orientation data is retrieved from the control unit. In this way, information about the use of the device may be stored and or communicated to e.g. a physician who may then be able to use the information to teach and to improve the patient's usage of the device.
| Number | Date | Country | Kind |
|---|---|---|---|
| 16185634.9 | Aug 2016 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2017/070638 | 8/14/2017 | WO | 00 |
