Orientation Indicator for a Medicament Delivery Device, a Medicament Delivery Device Comprising the Orientation Indicator, and a Trainer for a Medicament Delivery Device, Which Trainer Comprises the Orientation Indicator

Abstract

Orientation indicator for a medicament delivery device, which orientation indicator comprises a support element 20, an activation member 22 movable between a first position and a second position, an electrical circuit comprising a signal switch 29, a signalling element 26 connected to the electrical circuit, and wherein the activation 5 member 22 may move under gravitational force when the support element 20 is tilted, to actuate the signal switch 29, such that a signal may be generated by the signalling element 26.

Claims

1-14. (canceled)

15. Orientation indicator for a medicament delivery device, with a longitudinal axis (A) and having a delivery member; the device to be oriented with its delivery member pointing upwards during mixing or priming, which orientation indicator comprises: a support element having a proximal end and a distal end and generally elongated along the longitudinal axis (A) of the medicament delivery device, 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, characterized in that a signalling element connected to the electrical circuit, wherein the activation member is movable under gravitational force when the support element is tilted, to actuate the signal switch, such that a signal is generated by the signalling element informing a user that a proper orientation of the device is attained.

16. Orientation indicator for a medicament delivery device according to claim 15, wherein the activation member is made of conductive material, such that actuation of the signal switch, by the activation member, closes or opens the signal switch.

17. Orientation indicator for a medicament delivery device according to claim 16, wherein the activation member is slidably movable between the first position and the second position.

18. Orientation indicator for a medicament delivery device according to claim 16, wherein the activation member is rollably movable between the first position and the second position.

19. Orientation indicator for a medicament delivery device according to claim 16, wherein the activation member is made of a liquid conductor and wherein the liquid conductor may flow between the first position and the second position.

20. Orientation indicator for a medicament delivery device according to claim 19, wherein the liquid conductor is mercury and wherein the liquid conductor and the signal switch are comprises in a mercury switch.

21. Orientation indicator for a medicament delivery device according to claim 15, wherein the activation member is held fixed in the first position until released by a manually operable locking member.

22. Orientation indicator for a medicament delivery device according to claim 15, wherein 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.

23. Orientation indicator for a medicament delivery device according to claim 15, wherein the signal generated by the signaling element is an audible signal and/or tactile and/or a visual signal.

24. Orientation indicator for a medicament delivery device according to claim 15, wherein the support element is attachable to medicament delivery device.

25. Orientation indicator for a medicament delivery device according to claim 15, wherein the support element is integrated in a medicament delivery device.

26. Orientation indicator for a medicament delivery device according to claim 15, wherein 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.

27. A medicament delivery device comprising the orientation indicator according to claim 15.

28. The medicament delivery device according to claim 27, wherein the medicament delivery device comprises a delivery member through which a medicament of the medicament delivery device may be expelled.

29. The medicament delivery device according to claim 28, wherein the delivery member comprises a needle.

30. The medicament delivery device according to claim 28, wherein the delivery member comprises a nozzle.

31. The medicament delivery device according to claim 27, wherein the orientation indicator is integrated in the medicament delivery device

32. The medicament delivery device according to claim 27, wherein the orientation indicator comprises a separate module that may be attached to the medicament delivery device to provide an orientation indication function to the medicament delivery device.

33. The medicament delivery device according to claim 27, wherein the medicament delivery device comprises a first compartment and a second compartment.

34. The medicament delivery device according to claim 33, wherein an agent is stored in the first compartment of the medicament delivery device and a diluent is stored in the second compartment of the medicament delivery device.

35. A training device for a medicament delivery device, which training device comprises the orientation indicator according to claim 15.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0047] 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.

[0048] FIG. 1 a perspective view of a medicament delivery device comprising an orientation indicator according to the invention

[0049] FIG. 2 an exploded perspective view of the orientation indicator and the medicament delivery device

[0050] FIG. 3 perspective view of an orientation indicator attachable to a medicament delivery device

[0051] FIGS. 4-5 perspective views of the orientation indicator in use

DETAILED DESCRIPTION

[0052] FIG. 1 shows a perspective view of a medicament delivery device 10 comprising an orientation indicator according to the presently claimed invention. A support element 20, having a proximal end and a distal end, is shown. The support element 20 is generally elongated along a longitudinal axis A (FIGS. 3 and 4) of the medicament delivery device 10. An activation member 22 is movable in relation to the support element 20, between a first position and a second position. The activation member 22 may be accommodated in the support element 20. The first position and the second position may be defined as end points of longitudinal movement of the activation member 22 in relation to the support element 20. The activation member 22 may move between the first position and the second position, under influence of gravitational force, when the orientation indicator is tilted in relation to a horizontal plane.

[0053] FIG. 1 further shows a delivery member 50 through which a medicament of the medicament delivery device 10 may be expelled. The delivery member may be a needle, or a nozzle, or a mouthpiece, etc. A container (not shown), holding the medicament to be expelled, may be visible through a window 40.

[0054] The support element 20 of the orientation indicator may be integrated in a medicament delivery device as shown in FIG. 1. The support element 20 may also be a separate module that may be attached to a medicament delivery device 10 to provide an orientation indication function (FIG. 3) to almost any existing delivery device.

[0055] FIG. 2 displays the support element 20 as comprising an elongated compartment comprising the activation member 22. The support element further comprises a power source 24 and a signalling element 26. The power source 24 may for instance be a battery. The signalling element 26 may be sound-generating, such as a speaker, and/or visual, such as a light emitter or a display. The signalling element may also be tactile, such as a piezoelectric element configured to generate mechanical vibrations.

[0056] The support element 20 comprises an electrical circuit 28 (FIG. 6) and a signal switch 29. The signal switch 29 may be actuated by the activation member 22 by movement of the activation member 22 relative to the support element 20. The signal switch 29 may be actuated by the activation member 22 either opening or closing the signal switch 29. The signal switch is defined to be located at the second position of the activation member 22.

[0057] 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.

[0058] 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.

[0059] 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.

[0060] 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

[0061] 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.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] 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.

[0066] 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.

[0067] 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.

[0068] 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.

[0069] 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.

[0070] 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 FIGS. 4 and 5 may be turned between an inactive state 0 and an active state 1.

[0071] 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.

[0072] 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).

[0073] 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: [0074] a) The delivery member 50 is pointed downward. A negative signal is generated when the activation member 22 closes the signal switch 29 of the electrical circuit, i.e. the second position is located proximally of the first position. The activation member 22 moves downward to the second position to close the signal switch 29. [0075] b) The delivery member 50 is pointed downward. A negative signal is generated when the activation member 22 opens the signal switch 29 of the electrical circuit, i.e. the second position is located distally of the first position. The activation member 22 moves downward to the first position to open the signal switch 29. [0076] c) The delivery member 50 is pointed upward. A positive signal is generated when the activation member 22 closes the signal switch 29 of the electrical circuit, i.e. the second position is located distally of the first position. The activation member 22 moves downward to the second position to close the signal switch 29. [0077] d) The delivery member 50 is pointed upward. A positive signal is generated when the activation member 22 opens the signal switch 29 of the electrical circuit, i.e. the second position is located proximally of the first position. The activation member 22 moves downward to the first position to open the signal switch 29.

[0078] FIGS. 4-5 serve to exemplify the use of the orientation indicator. The illustrated case is applicable for alternative configurations (a) or (d) above. The medicament delivery device 10 comprises a second switch 60, which is in the inactive state 0. The medicament delivery device 10 is tilted such that the proximal end comprising the delivery member 50 is at an angle below the horizontal plane H. When compared to the situation shown in FIG. 3, where the delivery member of the medicament delivery device 10 is tilted an angle above the horizontal plane H, the activation member 22 of FIG. 4 has moved to the second position and has closed the signal switch 29. Since the medicament delivery device 10 is equipped with the manually operable second switch 60, no signal is generated since the second switch is in the inactive position 0.

[0079] When the user sets the second switch 60 to the active position 1 (FIG. 5), the signalling element 26 will be activated and may immediately generate a negative signal if configured as configuration (a) because the signal switch 29 is closed and the second switch 60 is in the active position. In an alternative embodiment the orientation indicator will generate a positive signal, if configured as configuration (d), as soon as the delivery member is tilted above the horizontal plane, because the activation member 22 will move towards the first position and thereby open the signal switch 29 while the second switch 60 is in the active position.

[0080] 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.

[0081] 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.