SUPPLEMENTARY DEVICE FOR AN INJECTION DEVICE

Abstract

In one aspect the present disclosure refers to a supplementary device (10) for a manually operable injection device (1), the supplementary device comprising: a body (11) attachable to an elongated housing (2) of the injection device (1), at least one connector (12, 14) connected to the body (11) and connectable to the housing (2), wherein the body (11) is attachable to the housing (2) via the at least one connector (12, 14), a sensor arrangement (20) coupled to at least one of the body (11) and the at least one connector (12, 14) and configured to measure a longitudinal force component (F) acting between the at least one connector (12, 14) and the body (11) in a direction parallel to the elongation of the housing (2).

Claims

1. A supplementary device (10) for a manually operable injection device (1), the supplementary device comprising: a body (11) attachable to an elongated housing (2) of the injection device (1), at least one connector (12, 14) connected to the body (11) and connectable to the housing (2), wherein the body (11) is attachable to the housing (2) via the at least one connector (12, 14), a sensor arrangement (20) coupled to at least one of the body (11) and the at least one connector (12, 14) and configured to measure a longitudinal force component (F) acting between the at least one connector (12, 14) and the body (11) in a direction parallel to the elongation of the housing (2).

2. The supplementary device according to claim 1, wherein the body (11) forms a handhold (15) with an outer surface (16) configured to be gripped by a palm of a hand of a user.

3. The supplementary device according to claim 1 or 2, wherein the body (11) comprises a hollow sleeve (18) with an inner diameter (di) that is larger than an outer diameter (do) of the housing (2) of the injection device (1).

4. The supplementary device according to claim 3, wherein the at least one connector (12, 14) is attached to an inner side (17) of a sidewall (19) of the hollow sleeve (18).

5. The supplementary device according to any one of the preceding claims, wherein the body (11) is shaped to enclose at least a portion of the elongated housing (2).

6. The supplementary device according to any one of the preceding claims, wherein the sensor arrangement (20) is integrated into at least one of the at least one connector (12, 14) and the body (11).

7. The supplementary device according to any one of the preceding claims, wherein the sensor arrangement (20) comprises at least one or more of a strain gauge (21), a force sensor (22), a pressure sensor (23), a switch (24) and a microphone (25).

8. The supplementary device according to any one of the preceding claims, further comprising a processor (30) electrically connected to the sensor arrangement (20) and configured to process and/or to record signals (40) obtainable from the sensor arrangement (20).

9. The supplementary device according to any one of the preceding claims, wherein the sensor arrangement (20) is configured to measure the longitudinal force component (F) quantitatively.

10. The supplementary device according to claims 7, 8 and 9, wherein the sensor arrangement (20) comprises a microphone (25) and at least one of a strain gauge (21), a force sensor (22), a pressure sensor (23) and a switch (24) and wherein the processor (30) is configured to start processing or recording of signals (40) from the sensor arrangement (20) when a magnitude of the longitudinal force component (F) is above a predefined threshold (T).

11. A kit (100) comprising a supplementary device (10) according to any one of the preceding claims and comprising a manually operable injection device (1), wherein the injection device (1) comprises: an elongated housing (2) with a distal end (3) and with a proximal end (4), a dose button (5) located at the proximal end (4), wherein the dose button (5) is depressible towards the distal end (3) to initiate dispensing of a dose of a medicament.

12. The kit according to claim 11, wherein the injection device (1) is configured to accommodate a cartridge (6) filled with the medicament and sealed towards the proximal end (4) with a piston (7) displaceable inside a barrel (8) of the cartridge (6) and wherein the injection device (1) further comprises: a drive mechanism (60) with a piston rod (61) to operably engage with the piston (7) for displacing the piston (7) towards the distal end (3), a click sound generator (64) configured to generate recurrent click sounds during a displacement of the piston rod (61) towards the distal end (3).

13. The kit according to claim 11 or 12, wherein the supplementary device (10) is attachable or is attached to a proximal portion (74) of the elongated housing (2) at a predefined distance from the proximal end (4).

14. A method of monitoring the operation of a manually operable injection device, the method comprising steps of: attaching a supplementary device (10) according to any one of the preceding claims 1 to 10 to an elongated housing (2) of the injection device (1) and connecting the at least one connector (12, 14) of the supplementary device (10) to a housing (2) of the injection device (1), grasping the supplementary device (10) with the injection device (1) attached thereto, measuring of a longitudinal force component (F) acting between a body (11) of the supplementary device (10) and the housing (2) in a direction parallel to the elongation of the housing (2) while a force (D) is applied to the dose button (5).

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0119] In the following, embodiments of the present invention will be described by making reference to the drawings, in which:

[0120] FIG. 1 schematically shows an injection device with a supplementary device attached thereto in an initial configuration,

[0121] FIG. 2 shows the devices according to FIG. 1 with the injection device in a configuration in which a dose is set and in which the injection device is ready for dispensing of a dose,

[0122] FIG. 3 is indicative of a block diagram of the supplementary device and of its components,

[0123] FIG. 4 is a diagram showing a signal output of the sensor arrangement over time during dose setting and dose dispensing,

[0124] FIG. 5 is a diagram in accordance to FIG. 4 illustrating a longitudinal force component over time together with a further diagram indicative of acoustic signals recorded and captured by a microphone,

[0125] FIG. 6 shows various implementations of the sensor arrangement and of different sensors to be used with the sensor arrangement and

[0126] FIG. 7 is a flowchart of the method of monitoring the operation of the injection device.

DETAILED DESCRIPTION

[0127] FIGS. 1 and 2 are illustrative of a manually operable injection device configured as a pen-type injector for dispensing of a liquid medicament 9 located inside a cartridge 6. The injection device 1 comprises an elongated housing 2. The housing 2 comprises various housing portions, e.g. a distal housing portion 73 that provides a support for the cartridge 6 and a proximal housing component 74 which is configured to accommodate a drive mechanism 60. The cartridge 6 typically comprises a vitreous barrel 8 of cylindrical or tubular shape.

[0128] The distal housing component 73 may be also denoted as a cartridge holder having a visual scale to visually indicate the filling level of the cartridge 6 accommodated therein. It is immediately apparent from a comparison of FIGS. 1 and 2, that the distal housing component 73 can be covered by a protective cap 72 that is detachably connectable to the distal housing component 73 or to the proximal housing component 74. The protective cap 72 serves to protect the distal housing component 73 against environmental influences, e.g. when there is no injection needle attached to the distal end 3.

[0129] The barrel 8 is sealed in proximal direction by a piston 7 that is slidably displaceable along the elongation of the cartridge 6 in order to expel the medicament 9 via a double-tipped injection needle that is detachably connectable to a distal end 3 of the housing 2. The double-tipped injection needle (not illustrated) typically comprises a cup-shaped needle hub for threaded engagement with the distal end 3 of the elongated housing 2. The distal end 3 typically comprises a central through opening to receive a proximal portion of the injection needle. When mounted to the distal end 3 the proximal end of the injection needle penetrates a distally located seal, e.g. a septum of the cartridge 6 so as to obtain access to the interior space of the barrel 8.

[0130] The distal end of the injection needle is configured to penetrate and to pierce biological tissue in order to deposit a dose of the liquid medicament 9 as the piston 7 advances towards the distal end 3 of the housing 2 and hence of the cartridge 6. The piston 7 is displaceable in distal direction by means of a piston rod 61, which is indicated in FIG. 2. Typically, the piston rod 61 comprises a radially enlarged pressure piece 62 at a distal end that is configured to apply distally directed pressure to the piston 7.

[0131] The manually operable injection device 1 may be characterized in that a force for displacing the piston rod 61 in distal direction is exclusively and completely provided by a user of the device. The piston rod 61 is a component of a drive mechanism 60 housed inside the proximal housing component 74 of the housing 2 of the injection device 1. At a proximal end 4 of the housing 2 there is provided a dose button 5, which in a proximally extended configuration as shown in FIG. 2 is depressible in distal direction and hence towards the distal end 3 by the user himself. In this way, a dispensing force D is applicable to the dose button 5 in order to displace the dose button 5 from the proximally extended configuration as shown in FIG. 2 into the initial configuration in which the dose button 5 is located close to the proximal end 4 of the housing 2. As indicated in

[0132] FIG. 2, the dose button 5 is provided at a proximal end of a sleeve 76 that is axially or longitudinally displaceable relative to the housing 2. The sleeve 76 may be configured as a dose indicating sleeve having a sequence of dose indicating numbers on its outer circumference that may show up in a dose indicating window 78 of the proximal housing component 74.

[0133] The dose button 5 as indicated in FIGS. 1 and 2 provides a double function. It has an annular shape with gripping features along its outer circumference. So for setting of a dose of variable or fixed size the dose button 5 is to be rotated either clockwise or counter-clockwise relative to the housing 2 in order to increase or to decrease a size of a dose during a dose setting procedure and prior to a dose dispensing or dose injection procedure.

[0134] The drive mechanism 60 typically comprises at least one or several clutches as well as some kind of a gear 65 to transfer a distally directed or rotative motion of at least one of the dose button 5 and the sleeve 76 into a distally advancing movement of the piston rod 61. The general operation and functionality of one example of a manually operable injection device is for instance known from any one of the documents WO 2004/078239 A1, WO 2004/078240 A1 and/or WO 2004/078241 A1. Such injection devices are well known in the art and are commercially distributed and need no further explanation here.

[0135] The manually operable injection device 1, in particular its drive mechanism 60 also comprises a click sound generator 64 that is configured to generate recurrent or regular audible sounds, such as click noises that are audible by a user of the device. A click sound generator 64 is configured to audibly indicate to a user, that at least a dose dispensing or dose injection procedure is currently in progress. The click sound generator 64 may be also active during dose setting so as to provide an audible feedback to a user that a discrete size of a dose has been actually dialed or set.

[0136] In FIGS. 1 and 2 there is further shown in cross-section a supplementary device 10 attached to the elongated housing 2 of the injection device 1. The supplementary device 10 comprises a body 11 with at least one connector 12, 14. As shown in FIGS. 1 and 2 the supplementary device 10 is attached to an outer circumference of the housing 2, in particular of the proximal housing component 74. The at least one connector 12, 14 provides a mechanical connection between the body 11 and the housing 2. The supplementary device 10 further comprises a sensor arrangement 20 that is coupled to at least one of the body 11 and the at least one connector 12, 14. The sensor arrangement 20 is furthermore at least configured to measure a longitudinal force component F acting between the at least one connector 12, 14 and the body 11 in a direction parallel to the elongation of the housing 2 and/or in a direction parallel to the elongation or parallel to the symmetry axis of the body 11 or of the supplementary device 10.

[0137] In the embodiment as shown in FIGS. 1 and 2 the body 11 is attached and fixed to the outer circumference of the housing 2 by means of the connector 12, 14. The connector 12, 14 may comprise various connector components or may comprise a single, e.g. annular-shaped connector 12 or 14 extending along the inner circumference of the body 11. When the at least one connector 12, 14 is fixed and attached to the outer circumference of the housing 2 any longitudinally directed forces acting between the body 11 and the housing 2 can be detected, measured and monitored by the sensor arrangement 20 and the supplementary device 10.

[0138] The body 11 of the supplementary device 10 further forms a handhold 15 with an outer surface 16 that is configured to be gripped or to be enclosed by a palm of a hand of a user. In other words, the body 11 forms a handhold to grasp and to hold the injection device 1 when the supplementary device 10 is attached to the housing 2. For dispensing of a dose a user typically applies a distally directed dispensing force D to the proximally extending dose button 5. The dispensing force D is typically applied to the dose button 5 with a thumb whereas residual fingers of the same user's hand grasp the handhold 15 and hence the outer surface 16 of the body 11 of the supplementary device.

[0139] The sensor arrangement is located in a flux of force between the body 11 and the housing 2. The sensor arrangement 20 is configured to detect and to measure a longitudinal force component F that is directed in an opposite direction compared to the dispensing force D. In other words, the longitudinal force component F substantially equals a reaction force to be provided by a user in order to displace the dose button 5 in distal direction relative to the housing 2. Apart from friction losses in the drive mechanism 60 the longitudinal force component F is substantially equal in magnitude to the dispensing force D.

[0140] As indicated in FIGS. 1 and 2 the body 11 may comprise a hollow sleeve 16 having an inner diameter di that is larger than an outer diameter do of the housing 2 of the injection device. In this way the body 11 and hence the entire supplementary device 10 can be slipped over the housing 2 of the injection device. Typically, the at least one connector 12, 14 protrudes inwardly from an inner side 17 of a sidewall 19 of the hollow sleeve 18 of the body 11. In this way, the at least one connector 12, 14 may provide a mechanical connection to the outer circumference of the housing 2. The at least one connector 12, 14 may be configured to positively engage or to frictionally engage with the housing 2. In some embodiments the dimensions and the geometries of the body 11, the at least one connector 12, 14 and the housing 2 are such, that a friction fit or a press fit can be obtained between the body 11 and the housing 2. Other embodiments may be based on mutually corresponding and complementary engaging connection members, such as positively engaging connection members that provide and enable a releasable positive engagement of the body 11 and the housing 2.

[0141] The supplementary device 10 and in particular its body 11 with the at least one connector 12, 14 attached thereto is releasably engageable with the housing 2. In this way, various injection devices 1 can be connected to the supplementary device 10 either on demand or sequentially. If the injection device 1 is intended to be discarded in its entirety the supplementary device 10 can be detached therefrom and can be connected and fixed to another, a new injection device. In this way the supplementary device 10 may provide an injection device-independent monitoring of device handling and injection procedures. The supplementary device is hence configured to capture and to log a dosing history conducted by a user.

[0142] The specific implementation and arrangement of the sensor arrangement may vary. The sensor arrangement 20 may be integrated into at least one of the connector 12, 14 and the body 11. The sensor arrangement 20 may be completely integrated or attached to the body 11. Then the sensor arrangement 20 will be connected or mechanically coupled to the connector 12, 14. In other embodiments the sensor arrangement 20 is integrated into or connected to the connector 12, 14. Then, it will be coupled to the body 11. In other embodiments the sensor arrangement 20 may be integrated or arranged in an interface section of connector 12, 14 and body 11. It may be hence integrated into both, the body 11 and the at least one sensor arrangement 12, 14.

[0143] It is also conceivable, that the connector 12, 14 is connected via the sensor arrangement 20 to the body 11. With all these embodiments the sensor arrangement 20 is located in the flux of force between a radially inwardly located end of the connector 12, 14 and a radially outwardly located handhold 15 or outer surface 16 of the body 11.

[0144] In FIG. 3 a schematic block diagram of the supplementary device 10 is provided. The supplementary device 10 comprises at least the body 11 and the at least one connector 12, 14. The at least one connector 12, 14 is indicated as an arrow in FIG. 3 that is configured to provide a mechanical connection to the injection device 1. The supplementary device 10 further comprises a sensor arrangement 20 which is either integrated into the body 11 or, as shown in dashed lines, which is located outside but close to the body 11. Optionally, the supplementary device 10 is further equipped with a processor 30 that is configured to receive and to process signals generated by the sensor arrangement 20. Further optionally the supplementary device 10 is equipped with a power source 31, typically in form of a battery or accumulator. The power source 31 provides electrical power and electric energy to the processor 30.

[0145] Further optionally there is provided a storage 32 that is configured to capture and to store data generated by the processor on the basis of signals obtained from the sensor arrangement 20. Alternatively, the storage 32 may be configured to store electric signals generated by the sensor arrangement 20. The processor 30 is typically configured to read and to write the storage 32. Further optionally there is provided an interface 33 in data communication with the processor 30. By means of the interface data previously stored in the storage 32 and/or electric signals provided by the sensor arrangement 20 can be transferred to an external device either wirelessly or by means of a wired data connection. The interface 33 may be implemented in accordance to commonly available wireless transmission hardware and standards, such as IEEE 802.11, Bluetooth, infrared-based communication protocols, NFC or RFID-based communication protocols, just to mention a few.

[0146] The processor 30 is typically provided with an internal clock so as to monitor the date and the time at which a dose dispensing procedure takes place.

[0147] In FIG. 6 various implementations of the sensor arrangement 20 are illustrated. The sensor arrangement 20 may comprise at least one or several of a strain gauge 21, a force sensor 22, a pressure sensor 23, a switch 24 and a microphone 25. The strain gauge 21, the force sensor 22, the pressure sensor 23 and the switch 24 may be implemented as alternatives. In addition to at least one of the strain gauge 21, the force sensor 22, the pressure sensor 23 and the switch 24 the sensor arrangement 20 may further comprise the microphone 25. In one embodiment the sensor arrangement comprises at least two sensors, namely a microphone 25 and one of a strain gauge 21, a force sensor 22, a pressure sensor 23 and a switch 24.

[0148] The microphone 25 is particularly configured to detect audible click sounds generated by the click sound generator 64 at least during dose dispensing and optionally also during setting of a dose. The force sensor 22 and/or the pressure sensor 23 may comprise at least one piezoelectric element, e.g. a piezoelectric layer that is configured to generate an electric signal in response to a mechanical load. The strain gauge 21 may be integrated or implemented inside or at the body 11 and/or at the connector 12, 14. By means of the strain gauge 21 an intrinsic mechanical load acting on the body 11 may be directly monitored.

[0149] In FIGS. 4 and 5 the signal 40 of the sensor arrangement 20 is printed over time measured in seconds. The signal 40 is indicative of the magnitude of the measured longitudinal force component F in Newton. As it is apparent from FIG. 4 after 2 seconds a force is detectable with a rather low magnitude, e.g. below 1 Newton. In the time interval between 2 seconds and 5 seconds the injection device 1 is subject to a dose setting procedure. During the dose setting procedure the interconnection of body 11 and housing 2 is not subject to a longitudinal force acting therebetween. After about 7 seconds a dispensing procedure starts. As indicated in the diagram 42 of FIG. 4, the measured force rises up to a level of about 10 Newton. At about 9 seconds the force level even rises up to about 11 or 12 Newton.

[0150] Between 7 and 10 seconds the pressure or force level applied to the dose button 5 is rather constant. It is a clear indication, that a rather constant dispensing pressure is applied to the dose button 5 in distal direction. The signal 40 as illustrated in FIG. 4 is directly indicative of the counterforce and hence of the longitudinal force component F detectable and quantitatively measurable by the sensor arrangement 20.

[0151] In the diagram 44 of FIG. 5 a force threshold T is illustrated in form of a horizontal line at about 3 Newton. With the present injection device 1 this threshold force T is a typical level at which a clutch of the drive mechanism 60 opens and at which a dispensing procedure will be initiated. There is further illustrated a second signal 46 that is indicative of the output of the microphone 25. As it can be seen from FIG. 5, the signal 46 of the microphone 25 exhibits various distinct and sharp peaks, each of which representing a click sound recorded by the microphone 25. Each peak in the signal 46 represents a distinct and discrete size of a dose. For instance, any peak or any click is indicative of a dosing step of 1 or 2 international units (IU) of insulin.

[0152] In order to measure a size of a dose actually dispensed by the manually operable injection device 1 the processor 30 of the supplementary device may be programmed in such a way, that only those signals 46 that occur at a time where the signal 44 is above the threshold T are counted in order to calculate the size of a dose actually dispensed. In the time interval between 2 and 5 seconds the signal 44 indicative of the longitudinal force component F is rather low and is below the given threshold T. The click sounds and hence the peaks of the signal 46 arising in the time interval between 2 and 5 seconds are considered to be irrelevant for the measuring or determination of the size of the dose. Only peaks of the signal 46 that coincide with the rising signal 44 and those click noises that are generated between 7 and 10 seconds and that coincide with a longitudinal force component above the given threshold T are counted and evaluated. Counting of these click noises immediately leads to the size of the dose actually dispensed.

[0153] So the at least one of a strain gauge 21, a force sensor 22, a pressure sensor 23 and a switch 24 may act as an activation switch for recording or for processing signals obtained from the microphone 25.

[0154] FIGS. 1 and 2 show a kit 100 that comprises the injection device 1 and the supplementary device 10, which is actually attached thereto. Contrary to the illustrated embodiment it is also conceivable, that the supplementary device 10 and the injection device 1 of the kit 100 are provided in a detached configuration so that the end user will have to attach the supplementary device 10 to the injection device 1. It is also conceivable, that the supplementary device 10 is commercially distributed independent of the injection device 1.

[0155] In FIG. 7 a flowchart of the method of monitoring the operation of the manually operable injection device 1 is given. In a first step 100 the supplementary device 10 as described above is attached to the housing 2 of the injection device 1. In a following step 102 the supplementary device 1 is grasped by a user with the injection device 1 attached to the supplementary device 10. Typically the user holds the kit 100 in a palm of a hand. In typical configurations the user actually uses the body 11 of the supplementary device 10 as a handhold 15. In a subsequent step 104 and assuming that a dose to be dispensed is already set, the user exerts a distally directed dispensing force D to the dose button 5 at the proximal end of the injection device 1.

[0156] In step 106 a counterforce, hence the longitudinal force component F measurable between the body 11 of the supplementary device 10 and the housing 2 of the injection device is measured. In step 108 it is determined and asserted if the measured longitudinal force component is above a predefined threshold T. If the force is below the threshold T the procedure returns to step 106. The loop of steps 106 and 108 is repeated as long as the measured pressure is below the predefined threshold T.

[0157] When it is determined in step 108 that the pressure level is above the given threshold T the method proceeds with step 110 in which a microphone 25 is activated or in which signals permanently provided by the microphone 25 are subject to further processing and analysis. Typically, in step 110 recurring or repeatedly arising click sounds generated by a click sound generator 64 of the injection device 1 are recorded and/or counted. After step 110 the procedure jumps back to step 106. As long as the applied dispensing force D and the resulting measured longitudinal force component F is above the threshold T consecutive click sounds will be recorded in step 110. In this way the size of a dose actually dispensed during application of a dispensing force onto the dose button 5 can be determined and calculated.

LIST OF REFERENCE NUMBERS

[0158] 1 injection device

[0159] 2 housing

[0160] 3 distal end

[0161] 4 proximal end

[0162] 5 dose button

[0163] 6 cartridge

[0164] 7 piston

[0165] 8 barrel

[0166] 9 medicament

[0167] 10 supplementary device

[0168] 11 body

[0169] 12 connector

[0170] 14 connector

[0171] 15 handhold

[0172] 16 outer surface

[0173] 17 inner side

[0174] 18 sleeve

[0175] 19 sidewall

[0176] 20 sensor arrangement

[0177] 21 strain gauge

[0178] 22 force sensor

[0179] 23 pressure sensor

[0180] 24 switch

[0181] 25 microphone

[0182] 30 processor

[0183] 31 power source

[0184] 32 storage

[0185] 33 interface

[0186] 40 signal

[0187] 42 diagram

[0188] 44 diagram

[0189] 46 signal

[0190] 60 drive mechanism

[0191] 61 piston rod

[0192] 62 pressure piece

[0193] 64 click sound generator

[0194] 65 gear

[0195] 72 protective cap

[0196] 73 distal housing component

[0197] 74 proximal housing component

[0198] 76 sleeve

[0199] 78 dose indicating window