PEN-TYPE DRUG INJECTION DEVICE WITH CONTROLLER AND TIME LOCK-OUT MECHANISM FOR ITS DRIVE

Abstract

Some aspects of the present disclosure relate to a drive mechanism for a drug delivery device. The drive mechanism includes: a piston rod to operably engage with a piston of a cartridge to displace the piston in a distal direction during a dose dispensing action, at least one actuation member mechanically coupled with the piston rod to induce a distally directed displacement of the piston rod when actuated by a user, a control to ascertain at least one predefined condition of use, and at least one interlock member coupled with the control to mechanically obstruct displacement of the piston rod if the condition of use is not fulfilled.

Claims

1. An injection device for injecting of a dose of a medicament, the injection device comprising: a housing to accommodate at least a cartridge filled with the medicament and a drive mechanism, the drive mechanism arranged inside the housing and comprising: a piston rod configured to engage with a piston of the cartridge and operable to displace the piston in a distal direction during and for injection of the dose of the medicament; and an actuation member operable to induce or trigger a distally directed displacement of the piston rod when actuated by a user of the injection device; and a control to register a contact of the injection device with a skin of a patient and to impede a distally directed displacement of the piston rod in the absence of a contact between the injection device and the skin of the patient.

2. The injection device according to claim 1, wherein the drive mechanism comprises a skin touch sensor near or at a distal dispensing end of the housing.

3. The injection device according to claim 2, wherein the skin touch sensor is connected to the control and wherein the control is operable to release a dose injection only in response to a detection of a skin contact.

4. The injection device according to claim 1, wherein the control is operable to release a dose injecting actuation only if the skin contact has been detected.

5. The injection device according to claim 1, wherein the control comprises an electronic control module.

6. The injection device according to claim 5, further comprising a timer circuit embedded in the electronic control module and operable to deactivate and/or to obstruct the drive mechanism for a predefined period of time.

7. The injection device according to claim 1, further comprising an indicator operable to provide at least one of a visual indication, an audible indication, or a tactile indication to a user of the injection device.

8. The injection device according to claim 7, wherein the indicator is implemented as one of a visual indicator operable to generate the visual indication, an acoustic indicator operable to generate the audible indication, or a tactile indicator operable to generate the tactile indication.

9. The injection device according to claim 7, wherein the control is operable to trigger at least one of the visual indication, the audible indication, or the tactile indication to the user of the injection device.

10. The injection device according to claim 7, wherein the control is operable to visually, audibly, or tactilely instruct a user to correctly operate or to correctly handle the injection device.

11. The injection device according to claim 7, wherein the control is coupled to the indicator and is operable to indicate to the user of the injection device if the contact between the injection device and the skin of the patient has been detected.

12. The injection device according to claim 7, wherein visual indicator comprises a light emitting diode LED.

13. The injection device according to claim 7, wherein the visual indicator comprises several light emitting diodes LED of different colors.

14. The injection device according to claim 1, wherein the drive mechanism comprises a power supply including a battery.

15. The injection device according to claim 14, wherein the control is operable to monitor the status of the battery.

16. The injection device according to claim 15, wherein the control is further operable to interlock the drive mechanism if a power provided by the battery drops below a predefined threshold.

17. The injection device according to claim 15, wherein the control is operable to indicate to the user that a change of the battery is due when a power provided by the battery drops below a predefined threshold.

18. The injection device according to claim 1, wherein the control is operable to store or to record an initial use of the injection device and to calculate a particular date after which the injection device should no longer be used.

19. The injection device according to claim 1, further comprising the cartridge filled with the medicament and arranged inside the housing.

20. The injection device according to claim 19, wherein the control is configured to automatically reset in response to an insertion of a new cartridge into the housing.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0125] In the following, preferred embodiments of the invention will be described by making reference to the drawings, in which:

[0126] FIG. 1 schematically illustrates a drug delivery device in form of a pen-type injector in a perspective view,

[0127] FIG. 2 shows the drug delivery device according to FIG. 1 in an exploded perspective view,

[0128] FIG. 3 shows a pen-type injector featuring various add-on modules and -components to provide self-actuated obstruction and interlock of the device and/or of its drive mechanism,

[0129] FIG. 4 is illustrative of a flowchart of a method to operate the drug delivery device,

[0130] FIG. 5 shows a mechanical implementation of an interlock member,

[0131] FIG. 6a is indicative of an electromechanical implementation of an interlock,

[0132] FIG. 6b shows the interlock member of FIG. 6a in transverse cross section,

[0133] FIG. 7a shows another embodiment of a mechanical interlock, and

[0134] FIG. 7b depicts a cross section of the embodiment according to FIG. 7a.

DETAILED DESCRIPTION

[0135] The pen-type injector 10 as shown in FIGS. 1 and 2 comprises a proximal body or housing component 12 and a distally located cartridge holder 16 that serves to accommodate a cartridge 22 being at least partially filled with a medicament to be injected. The proximal housing component 12 serves to accommodate a drive mechanism 20, which is not explicitly illustrated in FIGS. 1 and 2. The drive mechanism 20 at least comprises a piston rod 25 to operably engage with a piston of the cartridge 22.

[0136] The drive mechanism 20 further comprises a dose dial 18 as well as an injection button 17, by way of which a dose of the medicament can be set and dispensed. The dose dial 18 and the injection button 17 are located at a proximal end 15 of the drug delivery device 10.

[0137] The drive mechanism 20 is preferably implemented all-mechanically. For instance when rotating the dose dial 18 clockwise or counter-clockwise relative to the housing 12, the dose button 17 together with the dose dial 18 and an optional dose dial sleeve 23 may extend or displace in proximal direction 3 relative to the housing 12. As soon as a predefined dose is set, depressing the dose button 17 in distal direction 2 may induce a rotative and/or sliding motion of the piston rod 25, thereby displacing the piston of the cartridge 22 in distal direction 2. This way, the liquid medicament contained in the cartridge 22 can be expelled via a needle assembly to be releasably mounted on a threaded socket of the cartridge holder 16. When not in use, the device 10, in particular its cartridge holder 16 and cartridge 22 are to be covered with a protective cap 14. The cartridge holder also comprises an inspection window 13 by way of which the filling level of the cartridge 22 disposed therein can be visually inspected.

[0138] The overall design of the drug delivery device 10 as depicted in FIG. 3 may slightly deviate from the drug delivery device 10 as shown in FIGS. 1, 2 and FIGS. 5 to 7. However, since the various illustrated devices 10 and drive mechanisms 20 provide substantially comparable functionalities, the same or similar device components are denoted with identical reference numerals in the illustrated Figures.

[0139] As indicated in FIG. 3, the drive mechanism 20 of the drug delivery device 10 comprises at least one interlock member 30 being coupled with a control or control unit 36 in order to mechanically obstruct displacement of the piston rod 25 if a condition of use of the drive mechanism is not fulfilled. The interlock member 30 may comprise a latch or clutch-mechanism and may mechanically engage with the piston rod 25 in order to obstruct a longitudinal displacement or rotation thereof relative to the housing 12. The interlock member 30 may also releasably engage with any other component of the drive mechanism. Hence, it is conceivable, that the interlock member 30 engages with either the dose dial 18, with the injection button 17 and/or with the dose dial sleeve 23.

[0140] The control 36 further comprises or provides a time lock 37 adapted to frequently interlock or to frequently obstruct the piston rod 25 or the entire drive mechanism 20 for a predefined period of time. In this way, the risk, that a certain medicament is injected or dispensed too often can be minimized.

[0141] The control 36 and/or the interlock member 30 may be implemented all mechanically. The timer functionality of the control 36 may for instance also be integrated into the interlock member 30. A mechanical time lock may for instance be implemented in form of a clockwork which automatically activates with accomplishment of a previous dose dispensing action. Then, the clockwork or interlock member 30 may automatically and mechanically obstruct and impede repeated and immediate actuation of the drive mechanism 20 for a predefined period of time.

[0142] Alternatively, the control 36 can be implemented as an electronic device, wherein a time-lock functionality is implemented by way of an electronic circuit 37 serving as a timer module. The control 36 may be further equipped with a storage 39 in order to monitor and to log frequent and subsequent dose setting and dispensing procedures. This way, the module 36 may gather information about the total amount of medicament dispensed during a given period of time.

[0143] The drive mechanism 20 and/or the drug delivery device 10 also comprise a kind of power supply 38. In case of an electronic implementation of the control the power supply 38 comprises a battery, which may be rechargeable. With an all-mechanical implementation of the control 36, e.g. comprising a clockwork-like time-lock, the power supply 38 may comprise a spring energy accumulator, adapted to store mechanical energy in response of a user actuating the device. Moreover, the power supply 38 may comprise at least one converter, like a piezo-element, adapted to transfer mechanical power provided by a user into electric energy.

[0144] The control 36 may further monitor the status of the battery. Hence, when the power provided by the battery 38 drops below a given threshold, the control 36 may permanently interlock the drive mechanism 20 and may indicate to the user, that a change of the battery 38 is due soon.

[0145] Also, when inserting a new and filled cartridge 22 into the device 10, an injection counter of the control 36 may be manually or automatically reset. This way, the control 36 is able to provide information regarding the filling level of the cartridge. The control 36 is further coupled with a visual indicator 42 and/or with an acoustic indicator 44. The visual indicator 42 may be implemented as a light emitting diode (LED) or may comprise several LED that may feature different colours, like red and/or green.

[0146] The audible indicator 44 may comprise a speaker or some other acoustical indication means, like a buzzer, being at least capable to generate an acoustic alert. Additionally, the control 36 itself may feature a display in order to provide detailed information to a user, e.g. regarding the general device status and/or regarding conditions of use. The drive mechanism 20 may be further equipped with a vibration unit 40 that may feature a piezodrive allowing to set the entire device in a vibrational movement. This way, device-specific or prescription-schedule-specific information can be communicated to a user or patient in many different ways.

[0147] Interaction between control 36, interlock member 30 and indicating means 40, 42, 44 on the one hand allows to obstruct the drive mechanism 20 and to indicate to a user, that the device 10 is blocked or deactivated for a predefined period of time. On the other hand, the various indicators 36, 40, 42, 44 may also be used to indicate and/or to remind a user, that the next application of a dose is due.

[0148] The control 36 may also monitor the size of a dose set by a user and may compare the set dose size to be subsequently dispensed with the amount of the medicament still available in the cartridge 22. In the event, that the set dose exceeds the amount of medicament provided in the cartridge 22, the drive mechanism may either obstruct and indicate to a user that replacement of the cartridge 22 is due. Alternatively, the drive mechanism 20 and/or its control 36 may indicate the size of insufficient rest volume contained in the cartridge 22 and may still allow to dispense the residual amount of the medicament provided in the cartridge 22.

[0149] After completion such an insufficient dispensing, the control 36 may generate respective alerts or indications, that the cartridge 22 is to be immediately replaced and that a further amount of the medicament is still to be injected.

[0150] Moreover, by permanently monitoring the filling level of the cartridge 22, the control 36 may also be adapted to indicate to a user, that replacement of a cartridge 22 is due soon.

[0151] Additionally, the control 36 may also monitor, whether the expiry day of the medicament provided in the cartridge 22 has already been reached. Hence, the control 36 may store and/or record initial use of the medicament and may calculate a particular day after which the medicament should no longer be dispensed. If the expiry day of the medicament has been reached, the control 36 is adapted to automatically obstruct the drive mechanism 20. Then, the patient is enforced to replace the cartridge 22 by a new one. This way, a danger of misuse of a medicament can be effectively reduced.

[0152] Additionally, the control 36 may be programmable, e.g. by means of a programming device by way of which an attending physician or other authorized medical personal stores a predefined prescription schedule in the memory 39 of the control 36. Depending on the programming, the control 36 may either impede and/or encourage setting and/or dispensing of subsequent doses according to the given schedule. By storing respective injection and dosage information, the attending physician may also read out the storage 39 of the control 36 in order to monitor actual use of the device and to check, whether compliance with the given prescription schedule is attained.

[0153] Additionally, the drive mechanism 20 may comprise a communication and/or authorization module 34. The communication module 34 may be implemented wireless and may provide communication, preferably according to standard communication protocols, like RFID, Bluetooth or the like. By way of the communication and/or authorization module 34, the drive mechanism 20 and/or the drug delivery device 10 may communicate with an external transponder 46. This way, a kind of wireless keylock can be implemented in such a way, that release of the drive mechanism 20 only occurs in response to a detection of the transponder 46 being positioned within a predefined range in the vicinity of the drug delivery device 10.

[0154] Additionally, the transponder 46 may serve as a pager and may induce some kind of audible or visual alert by way of the wireless communication with the communication module 34. In case the patient is unaware of the actual location of the drug delivery device, he may induce a paging alert by way of the transponder 46, which is e.g. permanently kept by the user. In response to receive a paging signal from the transponder 46, the control 36 may induce an audible, visual or even vibrational alert by way of LED 42, speaker 44 and/or vibration unit 40. Also the transponder 46 may regularly send a paging signal to the drug delivery device in order to verify that the device 10 remains in close proximity to the user or patient. In situations the user e.g. intends to leave his home environment, the transponder 46 will check, if the user is keeping the drug delivery device 10 with him.

[0155] It is even conceivable, that the transponder 46 is used to indicate to the user, that the next dose setting and dispensing procedure is due. Then, the device 10 may transmit respective alert signal to the transponder 46, which in response to the received signal may generate a respective audible, vibrational or visual alert.

[0156] The drive mechanism 40 may be further coupled and connected with a skin touch sensor 28 allowing to determine, whether the device 10 is in contact with biological tissue intended and/or adapted to receive the dose of the medicament. As long as the skin touch sensor 28 transmits a respective signal to the control 36, that the skin of the patient has not yet been touched or pierced, the control 36 may hinder the drive mechanism 20 from dispensing of a dose already set.

[0157] Additionally, the drive mechanism 20 and/or the control 36 may communicate with a chemical analysis module 32, which is adapted to determine usability of the medicament contained in the cartridge 22. Hence, the chemical analysis module 32 may for instance be adapted to determine a pH-parameter of the medicament, which may be indicative, whether the pharmaceutical substance is still usable. In case an inappropriate pH-parameter is detected thereby indicating that the expire date has been exceeded, the chemical analysis module 32 generates a respective signal to the control 36, which then obstructs the drive mechanism 20, e.g. by way of the interlock member 30.

[0158] Furthermore, the drive mechanism 20 may be equipped with a pressure sensor 26 arranged between piston rod 25 and piston 24 of the cartridge 22. This way, mutual abutment of piston 24 and piston rod 25 can be precisely determined and/or monitored. Also, further procedural steps during or prior dose setting and dispensing can be precisely monitored and various functions, such like dose setting or dose dispensing can be blocked or obstructed if the user does not follow a predefined application procedure. The various sensors and detection modules allow to monitor, whether for instance a mandatory safety shot has been executed prior to an injection into biological tissue. Moreover, also a predefined dwell time, an injection needle should remain in the biological tissue after completion of dose dispensing can be at least indicated to the user.

[0159] Generally, by way of the various modules, sensors and by way of the control 36 a general access control as well as an effective child lock can be provided. Also, the drive mechanism 20 may enforce complete emptying of a cartridge 22 prior to cartridge replacement. The drive mechanism 20 may be individually programmed and configured to enforce and to provide user specific dispensing of subsequent doses of a medicament. Improper handling, operation or use of the device 10 may be at least recorded and may be displayed to the attending physician later on.

[0160] FIG. 4 is further illustrative of the various steps of handling and/or operating the device. Starting from a previous dose setting and dose dispensing procedure accomplished in step 100, a timer 37 will be for instance automatically started in step 102 by the control 36, either mechanically and/or electronically. The activated timer deactivates use of the device and the interlock member 30 is therefore activated impeding immediate setting and/or dispensing of the next dose in step 104.

[0161] When the predefined time interval has passed in step 106, the control 36 will deactivate the interlock member 30, thereby reactivating the dose setting and/or dose dispensing functionality in step 108. In a subsequent step 110 a subsequent dose can be set and/or dispensed.

[0162] The illustrated method is not limited to the timer as an example of a condition of use but universally applies to various different condition of use parameters, like battery life time, lifetime of the medicament, filling level of the cartridge, dosing history and/or prescription schedule.

[0163] FIG. 5 is further illustrative of a non-limiting example to implement a mechanical interlock member 50. There, the drive member 23 of the drive mechanism 20 is threadedly supported in a correspondingly threaded insert 52. By setting the drive member 23 in a screwing motion, e.g. by way of the dose dial 18 interconnected therewith, the drive member 23 will become subject to an axial displacement, either in proximal direction 3 or distal direction 2.

[0164] Additionally, the drive member 23 is engaged with a locking sleeve 54, preferably in a sliding or frictional way. The locking sleeve 54 is preferably engaged with the inside facing side wall of the housing 12. Since the locking sleeve 54 is separated from the insert 52 in distal direction 2 it can serve as an axial stopper for the drive member 23. The drive member 23 further has a distal stop element 56 extending radially outwardly from the drive member 23 at a distal end thereof. When the drive member 23 is for instance displaced in proximal direction 3, the stop element 56 is correspondingly displaced in proximal direction until its outer rim buts with the locking sleeve 54 being engaged with and fixed to the housing 12.

[0165] Preferably, the locking sleeve 54 is displaceably mounted in the housing 12. When positioned near the distally located stopper 56 of the drive member 23, the locking sleeve provides a kind of mechanical interlock, effectively impeding and preventing any proximally directed displacement of the drive member 23, e.g. for setting a dose. Positioning of the stopper 56 in a distal stop position therefore effectively obstructs activation and operation of the drive mechanism 20.

[0166] Moreover, when positioning the locking sleeve 54 at a predetermined axial position, a dose size limit can be provided. Hence, proximally directed displacement of the drive member 23 can be effectively delimited. A physician or other authorized medical staff may arrange the locking sleeve 54 in a predetermined axial position.

[0167] As further illustrated in the embodiment as shown in FIGS. 6a and 6b, the locking sleeve 54 is threadedly engaged with an inside facing side wall section of the housing 12. The locking sleeve 52 comprises an outer thread 66 which corresponds with an inner thread 68 of the housing 12. Here, the pitch of the mutually corresponding threads 66, 68 is of self-locking type. Hence an axially directed force between locking sleeve 54 and housing 12 does not induce a rotation of the locking sleeve 54 relative to the housing 12.

[0168] Moreover, axial displacement of the locking sleeve 54 can be attained by way of an electrically operated drive 58. The drive 58, typically to be controlled by the control 36 is mechanically coupled with a drive shaft 61 arranged in a bearing 62 located proximally from the drive 58. The drive shaft 61 comprises an axially elongated gear 60, which is engaged with a corresponding inner thread 64 of the locking sleeve 54. By rotating the shaft 61 and its gear 60, the locking sleeve 54 is set in rotational movement with respect to the housing 12, which comes along with an axial displacement of the locking sleeve 54 relative to the housing 12. This way, the axial distance between the locking sleeve 54 and the stopper 56 can be modified.

[0169] In the embodiment as illustrated in FIGS. 6a and 6b, the drive 58 is located distally from the locking sleeve 54. In an alternative embodiment, not illustrated here, it is also conceivable that drive 58, shaft 61, axially elongated gear 60 and bearing 62 are arranged on a proximal side of the locking sleeve 54. This way, a direct mutual abutment configuration between locking sleeve 54 and stopper 56 can be attained, e.g. in order to obstruct and/or to block operation of the drive mechanism 20 on demand.

[0170] FIGS. 7a and 7b further illustrate another embodiment of an interlock member 90. Here, an interlock element 74 is arranged near a distal end of the housing 12 to engage with the piston rod 25 of the drive mechanism 20. The piston rod 25 is threadedly engaged with a correspondingly threaded distal insert 70 portion of the housing 12. Therefore, the piston rod 25 is axially displaceable with respect to the housing 12 in a screw like motion. A respective screwing and rotating motion can be induced e.g. by exerting thrust to the dose button 18 in distal, hence dispensing direction. A distal displacement of the dose button 18 incurs a corresponding distally directed displacement of the drive member 23 threadedly engaged with a proximal portion of the piston rod 25. Since the threaded engagement of drive member 23 and piston rod 25 is of non-self-locking type, the piston rod 25 will become subject to a rotational movement in response of a distally directed displacement of the drive member 23.

[0171] The interlock member 74 is arranged on the threaded insert 70 near a central and threaded through opening 72 thereof. The interlock member 74 comprises radially inwardly extending interlock- and finger-like protrusions that engage and match with the outer thread of the piston rod 25. In the interlock configuration as shown for instance in FIG. 7a, any axial displacement of the piston rod 25 relative to the housing 12 is effectively impeded and obstructed.

[0172] The interlock member 74 is for instance pivot mounted to the insert portion 70 by way of a pivot axis 78 extending substantially parallel to the extent of the piston rod 25. By means of a radially extending pin 80 the interlock member 74 can be alternately disposed and positioned between the illustrated interlock configuration and a pivoted release configuration. As shown in FIG. 7b the pin 80 may either comprise a handle 84 or gripping end radially extending through a lateral through opening 82 of the housing 12.

[0173] By means of the pin 80 and the handle 84 the interlock member 90 can be reversibly or irreversibly transferred between an interlock and a release configuration, either manually or by way of a respective drive, which is not explicitly illustrated here.

[0174] Moreover and according to another alternative, it is also conceivable that the interlock element 74 is irreversibly detachable with regard to the insert 70. Instead of a pivoting arrangement, the interlock element 74 can be connected and attached to the insert 70 by way of a predetermined breaking portion. Then, the interlock element 74 may be irreversibly displaced in a release configuration e.g. by means of the pin 80.