A SYSTEM WITH A MONITORING DEVICE

Abstract

A system is presented including a monitoring device and a medicament delivery device, where the monitoring device is configured to be releasably connected to the medicament delivery device and wherein the monitoring device comprises an induction sensor configured to detect a state of an electrically conductive drive member of the medicament delivery device in an medicament delivery process through an electrical current which is generated by a magnet field by the induction sensor on the electrically conductive drive element.

Claims

1-13. (canceled)

14. A system comprising a monitoring device and a medicament delivery device wherein the monitoring device is configured to be releasably connected to the medicament delivery device and wherein the monitoring device comprises an induction sensor configured to detect a state of an electrically conductive drive member of the medicament delivery device in an medicament delivery process through an electrical current which is generated by a magnet field by the induction sensor on the electrically conductive drive element.

15. The system according to claim 14, wherein the induction sensor comprises an inductor coil; wherein the state of the electrically conductive drive member is detected through a change of impedance in the inductor coil generated by the inductor coil's electrical current.

16. The system according to claim 14, wherein the induction sensor comprises a first inductor coil and a second inductor coil; wherein the electrical current is induced on the second inductor coil from the first inductor coil.

17. The system according to claim 14, wherein the monitoring device further comprises one of a sound detector or a vibration detector.

18. The system according to claim 14, wherein the monitoring device further comprises an accelerometer or inertia measurement unit detector.

19. The system according to claim 17, wherein the detector is configured to detect a state of the medicament delivery device in a medicament delivery process.

20. The system according to claim 17, wherein the monitoring device further comprises a computing element capable of correlating the information from the induction sensor with the information from the detector when the state of said electrically conductive drive element is changed.

21. The system according to claim 14, wherein the electrically conductive drive element is a coil spring configured to change state from a compressed state to a relaxed state.

22. The system according to claim 14, wherein the electrically conductive drive element is a plunger rod configured to change state from a start state to a final state.

23. The system according to claim 21, wherein the induction sensor is configured to detect the state of the coil spring through the difference of the density of spring coils.

24. The system according to claim 21, wherein the induction sensor is configured to detect the absence or presence of the electrically conductive drive element in a sensing area.

25. The system according to claim 15 wherein the induction sensor further comprises a second inductor coil, configured to be induced with a current by the induction coil under the mutual inductance effect.

26. The system according to claim 14, wherein the medicament delivery device is an injector.

27. An medicament delivery system comprising: an injection device comprising a plunger rod that is electrically conductive and biased in a start state and movable from the start state to a final state; a monitoring device releasably connected to a housing of the injection device, where the monitoring device comprises: an induction sensor that detects movement of the plunger rod from the start state to the final state through an electrical current which is generated by a magnet field by the induction sensor.

28. The system according to claim 27, wherein the induction sensor comprises a first inductor coil and a second inductor coil, where the electrical current is induced on the second inductor coil from the first inductor coil.

29. The system according to claim 27, wherein the monitoring device further comprises a sound detector, a vibration detector, an accelerometer or inertia measurement unit detector.

30. The system according to claim 27, wherein the plunger rod is hollow and partially contains a coil spring that changes from a compressed state to a relaxed state.

31. The system according to claim 30, wherein the induction sensor detects a density difference of coils of the coil spring.

32. The system according to claim 30, wherein the induction sensor detects an absence or presence of either the plunger rod or the coil spring in a sensing area as the plunger rod moves from the start state to the final state.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0043] The specific embodiments of the concept of this disclosure will now be described, by way of example, with reference to the accompanying drawings, in which:

[0044] FIG. 1a displays a system comprises a monitoring device and a medicament delivery device.

[0045] FIG. 1b displays an exploded view of the monitoring device.

[0046] FIGS. 2a and 2b display a perspective cross-sectional longitudinal view of a first embodiment of the system.

[0047] FIGS. 3a and 3b display a perspective cross-sectional longitudinal view of a second embodiment of the system.

DETAILED DESCRIPTION

[0048] The present disclosure will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplifying embodiments are shown. The concept of this disclosure 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 this disclosure to those skilled in the art. Like numbers refer to like elements throughout the description.

[0049] FIG. 1a-1b generally illustrates a first embodiment of the system which comprises a monitoring device (1) and a medicament delivery device (2). The monitoring device (1) comprises a sleeve (11) defining a cavity for receiving the medicament delivery device (2); an attachment assembly (not show) configured to releasably hold the medicament delivery device in a specific position in relation to the sleeve (11). The attachment assembly can be of any type of releasable attachment assembly known for a person skilled in the art, e.g. cramping by a c-shape ring or cramping by a hinge connected hooking arm.

[0050] The monitoring device further comprises a computing element (10) embedded on a print-circuit board (PCB) with at least a processor, a memory and a communication unit; a battery and an induction sensor (12). The induction sensor (12) is a circuit with at least one inductor coil. In a first embodiment of the system as shown in FIGS. 2a-b the circuit comprises one inductor coil (121). In a second embodiment of the system as shown in FIGS. 3a-b the circuit comprises a pair of inductor coils (121′, 121″). The circuit is powered by the battery.

[0051] The medicament delivery device (2) comprises a body (21) receiving a medicament container (22). The medicament container (22) comprises a compartment that encloses a medicament therein and is sealed by a stopper. The medicament delivery device (2) further comprises a drive element (23), e.g. a power spring, configured to bias the stopper during a medicament delivery process, such like, at least one of the priming operation, the delivery start point, the delivery operation and the end of delivery; so that the medicament is ejected. The drive element (23) comprises at least an initial or compressed state and a final or relaxed state.

[0052] The delivery process of the medicament delivery device (2) is monitored by the induction sensor (12). The induction sensor (12) is arranged to detect a displacement from initial or compressed state to the final or relaxed state when the medicament delivery device (2) is attached to the monitoring device i.e. the system is in the attached state. The induction sensor can also be arranged to detect the absence or presence in the final state of the drive element (23) when the medicament delivery device (2) is attached to the monitoring device i.e. the system is in the attached state.

[0053] FIGS. 2a-b illustrate the first embodiment of the system in which the induction sensor (12) comprises a circuit with induction coil (121) and the drive element (23) is an electrically conductive component at least partially made of electrically conductive material permitting the flow of alternating currents (AC) that produce an alternating magnetic field of sufficient intensity to be detected by the induction coil in a specific position.

[0054] In the attached state, the medicament delivery device (2) is received in the cavity of the sleeve (11) in a specific position, such that the inductor coil (121) defines a central cavity which is at least partially wrapping and aligned with the medicament delivery container, and the drive element (23) is distally positioned in relation to central cavity defined by the inductor coil (121.)

[0055] FIG. 2b illustrates that during medicament delivery, the drive element (23) is moved forward to eject the medicament. The drive element (23) is therefore moved into the central cavity defined by the inductor coil (121). The movement of the drive element (23) from the initial or compressed state to the final or relax state causes changes of the metal density, from being fully compressed (high density) in the distal part of the device to being extended throughout the length of the device (low density).

[0056] To detect changes in metal density, the AC flowing in the inductor coil (121) will generate an alternating magnetic or electromagnetic field that will induce an eddy current on the drive element (23), and is relative to the quantity, distance, size, and composition of metal within the vicinity of the induction coil, which will change with the changing density of the spring. This eddy current generates its own opposing magnetic field (opposing the original field generated by the inductor coil) relative to the metallic object's conductivity, causing a change in the impedance of the circuit of the induction sensor (12). By sensing this change in impedance, the current state of the drive element (23) is detected, so that different states of the medicament delivery process such like pre-delivery, priming, ejection of the medicament, or end of delivery can be thereby detected by the induction sensor (12) based on the changes of the metal density of the drive element (23).

[0057] Instead detecting the displacement of the drive element (23) i.e. changes of the metal density of the drive element (23), the absence or presence of the drive element (23) can also be detected. This alternative way of detection can be performed by rearranging the inductor coil (121) such that the central cavity defined by the inductor coil (121) defines a sensing area and the drive element (23) will only pass through the central cavity of the inductor coil (121) at the end of delivery i.e. when the drive element is in its final or relaxed state, so that the end of delivery of the medicament delivery device (2) is detected by the induction sensor (12) through detecting the absence or presence of the drive element (23) in the sensing area.

[0058] FIG. 3a-b illustrate the second embodiment of the system in which the induction sensor (12) comprises a set of at least two inductor coils (121′, 121″).

[0059] The induction sensor (12) in this second embodiment comprises a circuit with a first inductor coil (121′) and a second inductor coil (121″).

[0060] In the attached state, the medicament delivery device (2) is received in the cavity of the sleeve (11) in a specific position, such that: —the first inductor coil (121′) defines a first central cavity which is at least partially wrapping and aligned with a distal portion of the medicament delivery container, —the second inductor coil (121″) defines a second central cavity which is at least partially wrapping and aligned with a proximal portion of the medicament delivery container, and —the drive element (23) is distally positioned in relation to first central cavity defined by the first inductor coil (121′). The second inductor coil (121″) is proximally and discretely arranged in relation to the first inductor coil (121′) and the second central cavity defined by the second inductor coil forms a sensing area. The first coil (121′) is powered by the battery once the monitoring device (1) is operated. Also in the attached state, the drive element (23) is distally arranged in relation to both first and second inductor coil.

[0061] FIG. 3b illustrates that during medicament delivery, the drive element (23) is moved forward to eject the medicament from the initial state to the final state. The drive element (23) is therefore moved into the first central cavity defined by the first inductor coil (121′) and thereafter into the second central cavity defined by the second inductor coil (121″).

[0062] Before the drive element is moved into the first central cavity, the mutual inductance between the first and the second inductor coils is nearly zero; on the other hand, when the drive element (23) is moved into both the first and the second cavity to its final state, i.e. at the end of delivery, the drive element (23) acts as an iron core and allows mutual inductance between the coils, so that the first inductor coil (121′) will induce a current on the second inductor coil (121″) and therefore, the appearance of the drive element (23) in the sensing area defined by the second cavity is detected by the induction sensor (12).

[0063] The pair of inductor coils arrangement used in the second embodiment can also be used in combination with the detection mechanism used in the first embodiment. In that case, the first inductor coil (121′) can be used to detect the priming and/or the progress of the delivery through changes of the impedance of the circuit of the induction sensor dependent on changes of the density of the drive element (23) with the way disclosed in first embodiment; and the second inductor coil (121″) can be used to detect the end of injection by detecting the appearance of the drive element (23) through the mutual inductance.

[0064] For the absence or presence detection by the mechanism described in either embodiments, the drive element (23) can also be a plunger rod of the medicament delivery device (2) which is made of an electrically conductive material. The plunger rod comprises an initial state in which the plunger rod is hold against a forward biasing force; and a final state in which the plunger rod is moved to its forward most position under a forward biasing force. That's especially important to use in a non-spring driven device or non-compression spring driven device, such like gas power medicament delivery device or the medicament delivery device with a torsion spring or a clock spring, which will not move in the proximal direction during delivery.

[0065] Further, for increasing the accuracy of the detection of the delivery process, a sound detector or a vibration detector can be used in the monitoring device. Since the induction sensor (12) and the detector are configured to detect different pattern of the medicament delivery device (2), the accuracy of the detection of the delivery process can be increased. The detector is configured to detect the state of the medicament delivery device (2) by detecting the vibration/click sound; which is a more dynamic method than detecting the state of the medicament delivery device occurred by the interaction of two components upon the occurrence; there is a risk of inaccuracy that when using the detector as the only one detection arrangement in the monitoring device (1), there might be the environment noise or the friction damage between two components after several times of usage, especially for a reusable medicament delivery device; on the other hand, the induction sensor (12) is configured to detect the state of the drive element (23); which is a more static method of identifying the state of the drive element (23) and calculating the state of the medicament delivery device (2) accordingly; the risk of inaccuracy of the induction sensor (12) as the only detection arrangement in the monitoring device (1) might be evident during a malfunction of the drive element (23). By using a second detector in conjunction with the induction sensor (12), the risk mentioned above can be avoided or mitigated.

[0066] Rather than the induction sensor (12) being configured to detect the state of the drive element (23), the detector may be configured to detect a state of the medicament delivery device (2), which is one of the specific states of the delivery process, such as at least one of the priming operations, the delivery start point, the delivery operation and the end of delivery; by detecting a mechanical click sound generated by the interaction of two components of the medicament delivery device (2); such as, the click sound generated by an action that the plunger rod hits the stopper or the spring hits the rear end of the medicament delivery device (2) under the reaction force. The detector can be an accelerometer or inertial measurement unit, which is able to detect the slight vibration and the vibration that is generated by a click sound; and used in conjunction with the induction sensor (12) in both embodiments. The accelerometer can be a 3-axis accelerometer, and/or a 3-axis gyroscope so that the unique characteristics of vibration or the click sound can be identified based on the direction, orientation, frequency and magnitude; therefore, environment noise can be attenuated.

[0067] After the medicament delivery device (2) is received into the sleeve (11), the accelerometer detects the beginning “click” to indicate the start of the attached stated. The accelerometer will then detect the second “click” to indicate start of delivery. The computing element (10) will correlate the information from the induction sensor (12) with the information from the accelerometer when the state of said electrically conductive drive element is changed, such as, said drive element (23) is in the end position, in order to register that a delivery event has occurred. So that, in the instance where the drive element (23) is a coil spring, spring jams or malfunctions of the medicament delivery device (2) can be detected if the second “click” is detected, but the end of injection is not detected by the induction sensor (12).

[0068] The detector can also be used to detect the end of delivery with the induction sensor, for increasing the accuracy of the detection of the end of delivery. In that case, the first “click” can be used to indicate the start of delivery and the second “click” can be used as the indication of the end of the delivery; and the information from the induction sensor (12) can be the “confirmation” of the injection process.

[0069] The detector might be also used to detect the dose setting in a variable dose medicament delivery device which is either a disposable medicament delivery device or a reusable medicament delivery device.

[0070] The delivery device can be an injector such as an auto-injector, an inhaler or an on-body device.

[0071] The present disclosure 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 disclosure, as defined by the appended claims.