GB2548131A

GB2548131A - Training cassette for auto-injector

Info

Publication number: GB2548131A
Application number: GB1604065.1A
Authority: GB
Inventors: Poon Steven
Original assignee: UCB Biopharma SRL
Current assignee: UCB Biopharma SRL
Priority date: 2016-03-09
Filing date: 2016-03-09
Publication date: 2017-09-13
Also published as: GB201604065D0

Abstract

A trainer cassette unit 101 for use with an auto-injector having an electrically powered drive unit comprises a trainer cassette unit housing 120 defining a cassette unit housing cavity and a forward projection aperture. A removable cap 150 fits over the cassette unit housing thereby acting to close off the forward projection aperture of the training cassette unit housing. The training cassette unit housing is further provided with one or more first engagement features 125 arranged for reversibly engaging one or more second engagement features 125 provided on the removable cap. A shuttle lock control 132 provides one or more blocking elements 134 for selectively blocking movement of the one or more first engagement feature relative to the one or more second engagement feature, thus enabling the removable cap to be locked to the cassette unit housing. The trainer cassette unit further comprises an identifier 121 that identifies the trainer cassette as being for use in training operations. The identifier may be an RFID tag that can be read by a drive unit of the auto-injector to identify the training cassette.

Description

TRAINING CASSETTE FOR AUTO-INJECTOR

Background

The present invention relates to a training cassette for use with a drive unit of an auto-injector device that is normally arranged for receipt of a cassette unit with a syringe for use in the injected delivery of a drug formulation to a patient.

It is well-known to use syringes for the delivery of injectable liquid drug formulation to a patient. Syringes rely on puncturing of the patient’s skin by a hollow needle through which the injectable liquid drug (e g. in solution or suspension form) is delivered to the muscle or tissue of the patient. Typically, syringes comprise a barrel for containing a volume of the liquid drug; a hollow needle defining a needle tip for dispensing of the liquid; and a plunger that is axially movable within the barrel.

It is also well-known to provide auto-injectors for use with syringes. Such auto-injectors typically comprise a body for housing the syringe and an actuating mechanism, which is triggered in use, to allow for automatic delivery of the liquid drug formulation from the syringe. Actuating mechanisms typically comprise a source of drive (e.g. a strong spring) for drivable movement of a drive transfer element (e g. a plunger rod) that transfers drive to the plunger for axial movement thereof within the syringe barrel. Such movement of the plunger results in the plunged driving of the liquid drug from the syringe barrel to the hollow needle for dispensing to the patient via the needle tip thereof

The majority of auto-injectors are configured as a single device that incorporates both syringe and actuating mechanism in the same device housing It is common for such devices to be arranged to be disposable such that following injected delivery of the liquid dmg formulation, and typically also following retraction of the syringe back into the housing, the whole device may be safely disposed of.

Summary

It is known to configure auto-injectors to include an electrically powered source of drive.

Such configurations are particularly suitable for use by patients whose manual dexterity is so compromised (e.g. due to severe arthritis) that electrical powering is of real practical assistance. The use of electrically powered drive systems can also allow for the use of electronic control systems and electronic data management systems including those that provide information and feedback to the patient by means of a suitable user interface.

In some situations, it is undesirable for an electrically powered auto-injector to be fully disposable. Auto-injectors have been proposed that include both a re-useable drive unit comprising an electrically powered source of axial drive and a cassette unit comprising a syringe, which releasably interfits with the drive unit and can be arranged to be disposable. The housing of the drive unit generally defines a docking cavity arranged for docking receipt of the cassette unit at a docking position. A suitable cassette unit comprises a cassette unit housing defining a cassette unit housing cavity and a needle projection aperture. The cassette unit housing cavity is arranged for receipt of a standard syringe comprising a syringe barrel for containing a volume of a liquid drug formulation, a hollow needle at a front end of said syringe barrel defining a needle tip for dispensing of the liquid drug formulation and a plunger that is axially movable within the syringe barrel. Either the syringe or the cassette unit and syringe held thereby is movable within the drive unit housing from a rest position, in which the needle tip of the syringe is within the drive unit housing to a use position, in which the needle tip protrudes from a needle delivery aperture of the drive unit housing. The cassette unit is also suitably provided with a removable cap that fits over and thereby, acts such as to close off, the needle projection aperture. A suitable drive unit includes a drive arrangement comprising an electrically powered source of axial drive. In certain implementations, the drive unit includes a first drive transfer element for transferring the axial drive to the cassette unit for advancing the syringe to said use position, and a second drive transfer element for subsequently transferring the axial drive to the plunger of the syringe for moving the plunger into the barrel of the syringe to eject at least part of the volume of liquid drug formulation.

One problem associated with the use of such an auto-injector having a re-useable drive unit and a separate cassette unit is to safely and conveniently allow for patient training in the use thereof. For such training purposes it is undesirable to employ a cassette unit that comprises a loaded syringe (’a prescription cassette unit’). It may be appreciated to be wasteful to fire typically expensive, drug formulation from a syringe during training operations. In addition, for safety reasons, it is undesirable for a syringe needle to be presented at all during such training operations. In part-solution of this problem. Applicant has appreciated the need for a training cassette unit that has for all practical purposes, a similar outward form to that of the prescription cassette unit, but which comprises no syringe component, no needle and no drug formulation therein.

According to one aspect of the present invention there is provided a trainer cassette unit for use with an auto-injector having an electrically powered drive unit, said trainer cassette unit comprising: a trainer cassette unit housing defining a cassette unit housing cavity and a forward projection aperture; and a removable cap that in a capping position fits over and thereby, acts such as to close off, the forward projection aperture of said training cassette unit housing, the training cassette unit housing being provided with one or more first engagement features arranged for reversibly engaging one or more second engagement features of said removable cap for reversible lock engagement of the removable cap to the cassette unit housing; a shuttle lock control defining one or more blocking elements for selectively blocking movement of said one or more first engagement features relative to said one or more second engagement features; and an identifier, which identifies the trainer cassette as being for use in training operations.

According to another aspect of the present invention there is provided an auto-injector comprising (a) a training cassette unit as described herein; and (b) a drive unit.

In embodiments, the drive unit comprising a reader and a display screen, wherein the reader of the drive unit detects the identifier as indicating a trainer cassette and prompts display of information relevant to a training cassette operation on the display screen.

These and other embodiments are set forth in the later description, which describes for illustrative purposes only various embodiments thereof.

In certain implementations, the drive unit includes a housing defining a docking cavity, wherein said docking cavity is arranged for docking receipt of said trainer cassette unit at a docking position. The trainer cassette unit is movable from a rest position to a use position.

In relation to aspects of the auto-injector device described herein the term ‘forward’ is used to mean that end of the device, which locates closest to the injection site in use (i.e. the needle tip end) and the term ‘rear’ or ‘rearward’ is used to mean that end of the device, which locates furthest from the injection site in use. The term axial herein is used by reference to an axis, which runs from the forward end of the device to the rearward end of the device.

There is provided a training cassette unit for use with an auto-injector device that is in normal (i.e. non-training operation) arranged for use with a cassette unit housing a syringe that contains a liquid drug formulation. The syringe is arranged to be suitable for use in the injected delivery of the liquid drug formulation to a patient. The trainer cassette unit however, contains no syringe.

The auto-injector herein comprises both a drive unit and a training cassette unit receivable by the drive unit. The individual drive unit and trainer cassette unit parts thereof comprise further separate aspects of the present invention. In embodiments the drive unit and trainer cassette unit are provided as a kit of parts.

Auto-injectors comprising both a drive unit comprising an electrically powered source of axial drive and a cassette unit comprising a syringe, which releasably interfits with the drive unit already have been described in Applicant’s PCT publications WO2012/164,390; WO2012/164,402; WO2012/164,404; WO2012/164,389; WO2012/164,397; WO2012/164,394; W02013/001378; WO2012/164,406; WO2012/164,403; W02014/019,997; WO2014/019,999; W02014/020,000; WO2014/020,001; WO2014/066,256; W02015/110,533; WO2015/110,532 and WO2015/110,529; and an alternative trainer cassette unit is described in Applicant’s GB publication GB2,524,525 Al, the contents of all of which are incorporated by reference in their entirety and made part of this application.

Cassette unit

The training cassette unit comprises a training cassette unit housing defining a training cassette unit housing cavity. The training cassette unit housing is arranged to be of equivalent size and shape to that of a cassette unit arranged for receipt of a syringe. The training cassette unit housing may be arranged as a single part or a multi-part (e.g. two part) cassette unit housing assembly.

The training cassette unit housing is provided with a removable cap that fits over and thereby, acts such as to close off, a forward aperture thereof.

The training cassette unit is provided with a cap lock (i.e. cap removal prevention) feature for selectively preventing removal of the removable cap. In embodiments, the cap lock feature is movable from a first cap locking position in which it prevents removal of the cap from the training cassette unit to a second cap un-locking position in which it no longer prevents such cap removal.

The training cassette unit is provided with a shuttle lock control defining one or more blocking elements for selectively blocking movement of said one or more first engagement features of the training cassette unit housing relative to the one or more second engagement features of the removable cap.

In embodiments, the shuttle lock control is axially movable relative to the training cassette unit housing between: (i) a first ‘training cassette unused’ position, in which said one or more blocking elements block movement of the one or more first engagement features relative to the one or more second engagement features, thereby keeping the removable cap in locked relationship to the training cassette unit housing; (ii) a second ‘training cassette unlocked’ position, in which said one or more blocking elements no longer block movement of the one or more first engagement features relative to the one or more second engagement features, thereby allowing for unlocking of the removable cap from the training cassette unit housing and for removal and replacement thereof; and (iii) after replacement of the removable cap, a third ‘training cassette used’ position, locating intermediate said first and second positions, in which the one or more blocking elements again block movement of the one or more first engagement features relative to the one or more second engagement features, thereby restoring the locked relationship between the removable cap and the training cassette unit housing.

In embodiments, the shuttle lock is biased from the second position to the third position.

In embodiments, in use, on removal of the removable cap the shuttle lock control is in the second position; during use of the cassette for injection the shuttle lock control is biased into the third position; and during replacement of the removable cap the shuttle lock control is in the second position.

In embodiments, the shuttle lock control is further provided with an axial position locator, which defines three distinct axial positions of the shuttle lock control relative to the training cassette unit housing and corresponding to the first, second and third positions.

In embodiments, the axial position locator comprises one or more axial protrusions each having a follower arranged thereon for receipt within a corresponding axial track of the inner trainer cassette unit housing such as to define an axial track-follower relationship therebetween.

In embodiments, the first and second positions correspond to the opposite extremes of the axial track-follower relationship.

In embodiments, each of the one or more axial protrusions of the axial position locator comprises a first latch element arranged for selective latching relationship with a corresponding second latch element of the inner trainer cassette unit housing.

In embodiments, the first latch element defines an axial latching slot and the second latch element comprises a latching foot selectively receivable thereby and movable therewithin such as to define an axial foot-in-slot relationship therebetween.

In embodiments, in the first position the axial latching slot and latching foot are in nonlatching relationship and in the second and third positions the axial latching slot and latching foot are in latching relationship, wherein the second and third positions respectively correspond to opposing slot ends of the axial latching slot.

In embodiments, the cassette unit (e.g. at the shuttle lock control) additionally comprising a non-return feature arranged such that when the first and second latch elements have come into latching relationship return to a non-latching relationship is prevented.

In embodiments, as part of the non-return feature the first latch element defines a forward ramped surface and the second latch element defines a corresponding ramped surface such as to facilitate ramping over each other when coming into latching relationship.

In embodiments, the shuttle lock control is marked with a ‘used training cassette’ flag arranged to be brought into registration with an indicator opening or window of the training cassette unit housing at the third ‘cassette used’ position.

In embodiments, the cap lock (i.e. cap removal prevention) feature selectively prevents removal of the removable cap until the training cassette unit locates at the docking position within the drive unit housing. In embodiments, the cap lock feature of the trainer cassette unit is only movable from a cap locking position to a cap non-locking position when the trainer cassette unit locates at the docking position within the drive unit housing. In embodiments, the cap lock feature is in the first position during insertion of the trainer cassette unit into the drive unit and moves to the second position when the trainer cassette unit is in the docking position in the drive unit.

In embodiments, the drive unit includes a cap lock release feature arranged such that on moving of the trainer cassette unit towards the docking position in the drive unit said cap lock release feature interacts with the cap lock feature of the trainer cassette unit to move the cap lock feature to the second cap unlocking position when the cassette unit is at the docking position in the drive unit.

Drive unit

The drive unit comprises a drive unit housing defining a docking cavity and a forward aperture. The docking cavity is arranged for docking receipt of the trainer cassette unit at a docking position, whereupon said trainer cassette unit is movable from a rest position to a use position. The docking cavity and receivable part of the trainer cassette unit are correspondingly sized and shaped to facilitate the intended docking relationship. The drive unit housing may be arranged as a single part or a multi-part (e.g. two part) drive unit housing assembly.

In embodiments, the drive arrangement comprises at least one electrically powered source of axial drive. The electrical power may be provided by mains electrical supply or by a battery, which in embodiments may be rechargeable.

Electrical energy may be conserved by a variety of means to enable the auto-injector to operate for longer on a given source of energy, such as a battery. Energy conservation or saving methods have additional advantages in terms of reducing the size requirements of the power source (eg. battery) and thus the weight and portability of the auto-injector.

In embodiments, the at least one electrically powered source of axial drive comprises an electrically powered motor. The motor may provide linear or rotary drive, but in general, rotary motors used in combination with suitable gearing arrangements are most suitable. The motor may for example, comprise a DC electric motor, a piezoelectric (PZ) motor, an ultrasonic motor, a solenoid motor or a linear motor. In embodiments, the electronic drive system comprises a DC motor, a PZ motor, a stepper motor or an ultrasonic motor. Embodiments are envisaged in which, plural electrically powered sources of axial drive are employed such as a different drive source (e.g. motor) for each of the first and second drive transfer elements.

The drive arrangement comprises a first drive transfer element for transferring axial drive to the cassette unit for advancing it to said use position; and a second drive transfer element for subsequently transferring further axial drive.

In embodiments, the first and second drive transfer elements are configured as separate parts. In other embodiments, the first and second drive transfer elements are in coupling relationship (e.g. via one or more coupling elements) or form an integral part of a single (i.e. composite) drive transfer element.

In embodiments, the source of axial drive is configured to selectively confer axial drive to the first and second drive transfer elements. Any manner of gearing and/or coupling arrangements may be employed to achieve this purpose.

In embodiments, the drive arrangement comprises one or more lead screw drive mechanism. In other embodiments, the drive arrangement comprises one or more rack and pinion drive mechanisms. In embodiments, any of such drive mechanisms directly comprise the first and / or second drive transfer elements. In other embodiments, any of such drive mechanisms may be arranged to communicate with the first and/or second drive transfer elements by suitable gearing or coupling arrangements.

In embodiments, the electrically powered source of drive is able to exert an axial drive force of up to 60N via the first and/or second drive transfer elements. In embodiments, the force exerted may be arranged to vary over the actuation profile such as from a range of 60 to 40N at the start of actuation to from 40 to 20N at the end of the actuation profile.

In embodiments, release of axial drive force (e.g. actuation of the electrically powered source of drive) is responsive to a trigger (e.g. a user-actuable trigger). In embodiments, the trigger comprises a button, switch or lever arrangement. In other embodiments, a press actuation mechanism that is actuable in response to pressing of the drive unit housing against the skin of a patient is also envisaged.

In embodiments, the first drive transfer element communicates directly or indirectly with a cassette unit holder that holds the training cassette unit within the drive unit such as to transfer drive to the cassette unit holder to thereby result in drivable movement of training cassette unit from the rest to the use position.

It is noted that fundamentally any electrically powered source of drive herein must convert electrical energy (e.g. stored in batteries) into mechanical motion for movement of the syringe and/or cassette unit and/or the plunger. Electric motors typically use electrical energy to produce rotational motion in the form of a rotating shaft. Various methods are well known for conversion of rotational energy into linear displacement of the plunger. Conceivable methods are a lead screw and worm gear arrangement, cams, a rack and pinion system or a system of rigid linkages using the lever principle. The various methods have certain advantages and disadvantages in terms of complexity, efficiency, mechanical advantage, gearing, maximum displacement velocity, maximum force etc.

Interaction of training cassette unit with drive unit

In embodiments, the drive unit includes a cassette unit holder for holding the training cassette unit within the drive unit housing. In embodiments, the cassette unit holder defines one or more inner walls against at least a part of which the training cassette unit seats when held within the cassette unit holder.

In embodiments, the cassette unit holder is sized and shaped such as to allow for a relatively tight clearance between the training cassette unit and the inner walls of the cassette unit holder. Such tight tolerances allow for reliable positioning of the training cassette unit within the cassette unit holder and drive unit.

In embodiments, the cassette unit holder is mounted within the drive unit for movement along the drive axis, which corresponds to the injection axis, thereby allowing for movement of the training cassette unit within the drive unit between its rest and in use (i.e. injected) positions. In embodiments, the cassette unit holder mounts to a linear slide that orients along a direction that is parallel with or corresponds to the drive axis.

In embodiments, the cassette unit holder is provided with one or more cassette unit locking features for reversibly locking the training cassette unit within the holder and hence, within the drive unit.

In embodiments, the one or more cassette unit locking features are arranged to be in a locking position when the training cassette unit is in the docking position.

In embodiments, in the locking position the one or more locking features of the training cassette unit housing align with corresponding features (e.g. apertures) of the cassette unit holder.

In embodiments, movement of the training cassette unit from the intermediate pre-docking position to the docking position results in movement of the one or more locking features from the non-locking to the locking position.

In embodiments, each cassette unit locking feature comprises a latching feature, lock tab feature or snap-lock feature. In embodiments, engagement of the locking feature provides tactile or audible feedback to the user as an indication that the training cassette unit has been correctly received within the cassette unit holder of the drive unit.

In embodiments, the cassette unit holder is provided with one or more cassette unit locking features protruding from the inner wall(s) thereof In embodiments, the cassette unit locking features are biased towards (e.g. in response to biasing means) or naturally bias towards the cassette locking position.

In embodiments, the cassette unit holder has plural (e.g. two) cassette unit locking features (e.g. snap lock-tabs) integral with and protruding inwards from the walls thereof.

In embodiments, each of the cassette unit locking features has one or more angled faces arranged such that the locking feature may be pushed outwards as a result of force applied to the angled face.

In embodiments, each cassette unit locking feature (e.g. lock tab) has angled faces at the top and bottom thereof arranged such that the locking feature (e g. lock tab) flexes outwards when a force (e.g. from an edge of another mechanical part) is pushed into them from either direction. In embodiments, the angled face at the bottom side of the locking feature allow for it to flex out of the way as the training cassette unit is inserted into the cassette unit holder until the training cassette unit is inserted to a holding and locking position, wherein the locking feature flexes back to its original position and lockingly engages the cassette unit housing. In this position the cassette unit is held in the cassette unit holder by the locking features (e.g. lock-tabs) because the top faces of the locking features (e.g. lock-tabs) support the training cassette unit. The angled faces on the top of the locking features (e.g. lock-tabs) also allow for the cassette unit to be pulled out of the cassette unit holder by having the lock-tabs flex outwards in a similar fashion as when a training cassette unit is inserted into the cassette unit holder of the drive unit of the auto-injector.

In embodiments, once the training cassette unit has been inserted initially into the cassette unit holder, a reader of the drive unit reads an identifier on the training cassette unit to verify details relating to it. Once positive verification has been established, the training cassette unit is transported to the docking position such as by drawing it into the drive unit. In embodiments, this receipt of the training cassette unit into the cassette unit holder corresponds to the pre-docking intermediate position referred to hereinafter.

In embodiments, as the training cassette unit is transported to the docking position within the drive unit, the one or more locking features of the cassette unit holder are aligned with rigid features within the drive unit that maintain the locking features in the locking position such as by preventing lock-tabs from flexing outwards. Thus, the training cassette unit is effectively locked within the drive unit when the locking features are aligned with these rigid features of the drive unit.

In embodiments, once the training cassette unit has been received at the docking position the removable cap is removed. Where in embodiments, there is a cap lock feature this must first be released. In embodiments, as the training cassette unit is moved to the docking position (e g. by being drawn fully up into the drive unit) the training cassette unit is also brought into contact with cap lock unlocking features, which in embodiments comprise one or more (e g two) rigid arms, which extend into the training cassette unit to depress, and thereby to unlock, the cap lock feature. In embodiments, the rigid arms move into the training cassette unit to depress, and thereby to unlock, the cap lock feature by passing through cut-outs in the top of the cassette unit holder.

In embodiments, to move the training cassette unit within the drive unit, a first drive transfer element (e.g. a lead-screw) connects to (e.g. by threading through) a flange connecting to the cassette unit holder.

In embodiments, the cassette unit holder mounts to a linear slide such that it is slidably movable in a direction parallel to or corresponding to the drive axis. In embodiments, the first drive transfer element (e.g. lead-screw) couples to the output shaft of a motor / gear-head assembly such as via a universal joint. The universal joint allows for misalignment between the drive axis and the linear slide, which allows that the cassette unit holder and motor can be held rigidly in the drive unit without over-constraining the positioning of the cassette unit holder. Over-constraining the cassette unit holder could cause excessive friction or binding in the threads of the lead-screw and nut and so make high accelerations and velocities of the cassette unit holder difficult to achieve.

In embodiments, the drive unit is arranged to initially receive the cassette unit housing at an intermediate pre-docking position for subsequent transport of the cassette unit to the docking position.

In embodiments, the drive unit is arranged to initially receive the training cassette unit housing at the intermediate pre-docking position for automated verification thereof Such verification can for example, be for the purpose of checking of drug and dosage information, checking that the drug is not past its expiry date and / or checking that the cassette has not been used previously.

In embodiments, the training cassette unit is receivable by a cassette unit holder of the drive unit and the position corresponding to (e g. initial) receipt of the training cassette unit into the cassette unit holder corresponds to the intermediate position at which the automatic verification step is carried out.

The training cassette unit further comprises an identifier, which identifies the trainer cassette as being suitable for use in training operations, and thus differentiates it from standard cassette units, which typically comprise a syringe, needle and drug formulation. The identifier comprises data in a form that may be readily subject to interrogation. The drive unit comprises a reader for reading (interrogating) the identifier of the training cassette unit and, in communication with the reader, a verifier for verifying the identifier. In embodiments, the drive unit detects the identifier as indicating a trainer cassette and prompts an additional screen, which is relevant to a training cassette operation rather than to a standard drug delivery operation from a standard cassette unit.

In embodiments, the drive unit is arranged such that transport of the training cassette unit to the docking position is permitted only following positive verification of the identifier. Thus, only appropriately identified cassette units are finally receivable into the device to enable injected drug delivery there from.

In embodiments, the identifier may include labelling selected from the group consisting of visual text, machine-readable text, bar codes, and dot codes. In embodiments, the identifier is in the form of a passive transceiver (e.g. an RFID tag) that is interrogable by means of an active transceiver (e.g. an RFID reader). In embodiments, the identifier is in the form of a bar code that is interrogable by means of a bar code reader.

In embodiments, the training cassette unit comprises a first transceiver for transmitting and receiving data and the drive unit comprises a second transceiver for transmitting and receiving data, wherein data is transferable at least from the first transceiver to the second transceiver, and in embodiments in two-way fashion from the first transceiver to the second transceiver. The data is in embodiments in digital form and suitable for transfer by electronic, radio or optical means.

An advantage of embodiments of this type is the ability to store many types of information in different parts of the memory structure of the transceivers. The information is furthermore stored in a form, which is readily and accurately transferable. The information could for example, include manufacturing and distribution compliance information written to the memory at various points in the manufacturing or distribution process, thereby providing a detailed and readily accessible product history of the cassette unit housing. Such product history information may, for example, be referred to in the event of a product recall. The compliance information could, for example, include date and time stamps. The information could also include a unique serial number stored in encrypted form or in a password protectable part of the memory, which uniquely identifies the drug product and therefore may assist in the detection and prevention of counterfeiting. The information could also include basic product information such as the nature of the drug and dosing information, customer information such as the name of the intended customer, and distribution information such as the intended product destination.

On loading the drive unit with the training cassette unit housing the second transceiver may, for example, read the unique serial number, batch code and expiry date of the drug and any other information on the first transceiver. In this way the nature and concentration of the drug in the syringe of the cassette unit, may be determined. Other information, such as the date and time of administration of the drug, or environmental exposure data such as the minimum / maximum temperatures or levels of humidity the cassette unit has been exposed to, may also be read and displayed to the user. In embodiments, this information is displayed to the patient on a visual display unit.

Data may also be transferred to and from any transceiver during the period of use of the autoinjector by the patient. For example, the auto-injector may include an electronic data system having various sensors associated therewith. Any data collected by the sensors or from any data collection system associated with the electronic data system including a clock or other date/time recorder is transferable. Data may be transferred each time the patient uses the autoinjector Or alternatively, data may be stored in a database memory of the electronic data system and periodically downloaded to any transceiver. In either case, a history of the usage of the auto-injector may be built up in the memory of any transceiver or within the device non-volatile memory.

In embodiments, the first and second transceiver each comprise an antenna or equivalent for transmitting or receiving data and connecting thereto a memory. The memory will typically comprise an integrated circuit chip. Either transceiver may be configured to have a memory structure, which allows for large amounts of information to be stored thereon. The memory structure can be arranged such that parts of the memory are read-only, being programmed during/after manufacture, other parts are read/write and further parts are password protectable. Initial transfer of information (e.g. at the time of manufacture or of dispensing) to or from any transceiver can be arranged to be readily achievable by the use of a reader which is remote from the auto-injector, thereby minimising the need for direct product handling.

In embodiments, data is transferable (e.g. in two-way fashion) between the first transceiver on the training cassette unit and second transceiver on the drive unit without the need for direct physical contact therebetween. In embodiments, data is transferable wirelessly between the first and second transceiver.

In embodiments, the second transceiver on the drive unit is an active transceiver and the first transceiver on the training cassette unit is a passive transceiver. The term active is used to mean directly powered and the term passive is used to mean indirectly powered.

In embodiments, the first transceiver on the trainer cassette unit comprises an identifier or tag comprising an antenna for transmitting or receiving interrogating energy; and an integrated circuit chip connecting with said antenna, and the second transceiver on the drive unit comprises a reader for said identifier or tag. In this case the identifier or tag is a passive transceiver and the reader is an active transceiver. In embodiments, the reader is not in direct contact with the tag or identifier that is to be read.

In embodiments, the tag is on a carrier and the carrier is mountable on the trainer cassette unit. In embodiments, the carrier comprises an insulating material such as a glass material or, a paper material or an organic polymeric material such as polypropylene.

The interrogating energy may be in any suitable form including ultrasonic, infrared, radiofrequency, magnetic, optical and laser form. Any suitable channels may be used to channel the energy including fibre optic channels. hi embodiments, the first transceiver on the trainer cassette unit comprises a radiofrequency identifier (RFID) comprising an antenna for transmitting or receiving radiofrequency energy; and an integrated circuit chip connecting with said antenna, and the second transceiver comprises a reader for said radiofrequency identifier. In this case the radiofrequency identifier is a passive transceiver and the reader is an active transceiver. An advantage of radiofrequency identifier technology is that the reader need not be in direct contact with the radiofrequency identifier tag or identifier to be read.

The radiofrequency identifier can be any known radiofrequency identifier. Such identifiers are sometimes known as radiofrequency transponders or radiofrequency identification (RFID) tags or identifiers. Suitable radiofrequency identifiers include those sold by Phillips Semiconductors of the Netherlands under the trade marks Hitag and Icode, those sold by Amtech Systems Corporation of the United States of America under the trade mark Intellitag, and those sold by Texas Instruments of the United States of America under the trade mark Tagit.

In embodiments, the antenna of the RFID tag is capable of transmitting or receiving radiofrequency energy having a frequency of from 100 kHz to 2.5 GHz. Preferred operating frequencies are selected from 125 kHz, 13.56 MHz and 2.4 GHz.

In embodiments, the first transceiver on the trainer cassette unit comprises a magnetic identifier or tag comprising an antenna for transmitting or receiving magnetic field energy; and an integrated circuit chip connecting with said antenna, and the second transceiver on the drive unit comprises a reader for said magnetic identifier or tag. In this case the magnetic identifier or tag is a passive transceiver and the reader is an active transceiver.

In embodiments, the first transceiver on the cassette unit comprises a microelectronic memory chip and the second transceiver on the drive unit comprises a reader for said microelectronic memory chip. The microelectronic memory chip may comprise an Electrically Erasable Programmable Read Only Memory (EEPROM) chip, a SIM card-type memory chip or a flash type memory chip. In this case the microelectronic memory chip is a passive transceiver and the reader is an active transceiver.

Once the reader has read (or interrogated) the identifier of the trainer cassette unit, that identifier data is communicated to a verifier, which conducts a verification step.

In embodiments, the verifier carries out the verification by comparing one or more pieces of data read from the identifier with acceptable data values. In embodiments, the comparison makes reference to a look-up table of acceptable values, which may include data that is patient specific. In one embodiment, the acceptable values of look-up table are pre-loaded into an electronic data unit of the drive unit. In another embodiment, the acceptable values of look-up table are downloadable to an electronic data unit of the drive unit (e.g. by communicating with an online data source). In one embodiment, the acceptable values of look-up table are calculable by an electronic data unit of the drive unit (e g. based on data input by the user or feed-ins from sensors of the device).

In embodiments, the drive unit is arranged such that transport of the trainer cassette unit from the intermediate position to the docking position is permitted only following positive verification of the identifier. Thus, only appropriately verified trainer cassette units are finally receivable into the device for drug delivery there from.

In embodiments, that transport of the cassette unit to the docking position is by automatic control under the action of the electrically powered source of drive Thus, in embodiments positive verification of the cassette unit gives rise to a ‘transport to docking position’ signal from the electronic data unit to the source of drive, which results in the required transporting action.

Kit of parts

In embodiments, there is also provided a kit of parts comprising a trainer cassette unit (which may in embodiments, be in kit of parts form) as described above; and a drive unit as described above.

In embodiments, there is further provided a kit of parts comprising an auto-injector (which may in embodiments, be in kit of parts form) as described above; and packaging therefor. Suitable packaging typically comprises a storage container for the drive unit and one or more cassette units.

Brief Description of the Drawings

The disclosure is further described with reference to the accompanying drawings, in which:

Figure 1 is a perspective view of a prior art cassette unit for an auto-injector and shown in the ‘pre-use’ configuration;

Figure 2 is a sectional view of the prior art cassette unit of Figure 1 arranged for use with a 1ml syringe also in the ‘pre-use’ configuration;

Figure 3 is an exploded view of the prior art cassette unit of Figure 1;

Figure 4 is a side view of a trainer cassette unit herein;

Figure 5 is a sectional view of the trainer cassette unit of Figure 5;

Figure 6 is a second sectional view of the trainer cassette unit of Figure 4, but rotated 180° compared to the view of Figure 5;

Figure 7 is an exploded view of first trainer cassette unit herein of Figure 4;

Figures 8a and 8b are perspective side-on views of a shuttle lock control part-assembly of the prior art cassette unit of Figures 1 to 3 or the trainer cassette unit of Figures 4 to 7 at respective, first ‘cassette unused’ and third ‘cassette used’ positions;

Figure 8c shows the separate cassette unit housing and shuttle lock control parts of the part-assembly of Figures 8a and 8b;

Figures 9a to 9c are close-up perspective side-on views of the shuttle lock control part-assembly of Figures 8a and 8b at respective, first ‘cassette unused’, second ‘cassette unlocked’ and third ‘cassette used’ positions;

Figures 10a to 10c are sectional views taken along the line A-A’ of Figures 9a to 9c of the shuttle lock control part-assembly of Figures 8a and 8b at respective, first ‘cassette unused’, second ‘cassette unlocked’ and third ‘cassette used’ positions;

Figures 1 la to 1 Ic are sectional views taken along the plane bisecting locking arm 24 of Figures 9a to 9c of the shuttle lock control part-assembly of Figures 8a and 8b at respective, first ‘cassette unused’, second ‘cassette unlocked’ and third ‘cassette used’ positions;

Figure 12 is a perspective view of a first drive unit, particularly suitable for use with the prior art cassette unit of Figures 1 to 3 or the trainer cassette unit of Figures 4 to 7; and

Figure 13 is a perspective view of the first drive unit of Figure 29 with a first trainer cassette unit of Figures 4 to 7 received at the docking position.

Detailed Description

To provide an overall understanding of the systems, devices and methods described herein, certain illustrative embodiments will now be described. It will be understood by one of ordinary skill in the art that the systems, devices and methods described herein may be adapted and modified as is appropriate, and that these systems, devices and methods may be employed in other suitable applications, such as for other types of drive units and trainer cassette units, and that other such additions and modifications will not depart from the scope hereof

Figures 1 to 3 show a prior art cassette unit 1 of an auto-injector herein arranged for use with a 1ml syringe 10 that contains a liquid drug formulation (not shown). The cassette unit 1 comprises an elongate form cassette unit housing 20 having an end-cap 40 that is arranged for receipt of the syringe 10 and is sized and shaped for this purpose. The cassette unit housing 20 and inner housing sleeve 30 contained thereby are made of clear plastic to allow for viewing of the syringe 10 to provide a visual indication of use. The inner housing sleeve 30 is further provided with security label 21, which may in aspects be an RFID tag label for use in verification purposes. The cassette unit 1 is provided with a removable cap 50 that is arranged to engage the needle cover 19 via cap insert 90 of the syringe 10 and that is shown at Figures 1 and 2 in the capped position. The cap 50 is provided at the brim thereof with a peripheral arrangement of through-hole (i.e. socket like) first engagement features 52 (not visible on Figure 2). The cap 50 is shaped to define a ring pull 54 for receipt by the finger of a user. The cap 50 is also provided with two axial guide channels 53 (spaced at 180° intervals, only one visible on Figures 1 and 3), each for receipt of head 91a of a protruding leg 91 of cap insert 90.

The gripping ring 54 of the removable cap defines a finger aperture to receive a patient's thumb or other preferred finger for pulling the removable cap away from the cassette unit 1 to expose the needle 14. In certain embodiments, the finger aperture is adapted to receive a hook that some patients use to pull the removable cap 50 away from the cassette unit 1. The removable cap 50 with gripping ring 54 makes it easier for patients to engage and disengage the needle cover 17 and rigid needle shield 19 from the syringe barrel 12 as it does not require the patient to contort their fingers by pressing on the sides of a narrow needle cover 17/19. As noted before, the present auto-injector is intended for use by patients having compromised manual dexterity who may therefore experience difficulty pulling a conventional needle cover 17 and/or rigid needle shield 19 off the syringe 10 before self-injection. The gripping ring 54 addresses this need by allowing the patient to simply put the thumb or other preferred finger through the finger aperture 54 and pull on the removable cap to thereby remove the needle cover 17 and rigid needle shield 19.

The syringe 10 is of a standard 1ml type and comprises a barrel 12 with end flange 16 for holding a liquid drug formulation; a hollow needle 14 at one end of the barrel 12; and a syringe plunger 18 in the form of a rubber stopper that is arranged for axial movement within the barrel 12 such as to enable the liquid drug formulation to be expelled through the hollow needle 14. As shown at Figure 2, the syringe plunger 18 is at the ‘pre- use’ position. The hollow needle 14 defines a needle bore, which is of circular cross-section (e.g. 23G, 25G or 27G diameter) and a needle tip 15. The needle tip 15 is sheathed by needle sheath 17, which is also provided with rigid needle sheath shell 19.

The cassette unit housing 20 of the cassette unit 1 is arranged to define a cassette unit housing cavity that is sized and shaped for generally fixed receipt of the syringe 10. The cassette unit housing 20 defines at its forward end a needle delivery aperture 23 through which in use, the hollow needle 14 of the syringe 10 and a portion of the glass hub thereof protrudes on removal of the cap 50 there from. The cassette unit housing 20 is arranged to receive at its rearward end an end-cap 40 close to which the end flange 16 of the syringe 10 seats.

The cassette unit housing 20 is provided with a radial arrangement of first engagement features in the form of movable locking legs 24 defining angled tips 25 (not visible on Figure 2) thereon arranged for reversibly engaging the corresponding radial arrangement of second engagement features in the form of socket through holes 52 of the removable cap 50 for reversible lock engagement of the removable cap 50 to the cassette unit housing 20.

The cassette unit 1 is provided with an inner housing sleeve 30 for sleeved receipt of the syringe 10 The rear part of the inner housing sleeve 30 is provided with a spaced pair of rearward protruding arms 31. The inner housing sleeve 30 also forms a shuttle lock control feature 32 defining a radial arrangement of blocking elements 34 for selectively blocking movement of the movable locking legs 24 of the cassette unit housing 20 relative to the socket holes 52 of the cap 50, thereby providing for selective control of cap locking / unlocking. Return spring 35 is also provided.

Applicant has found that to reduce the risk of the syringe 10 fracturing under the loads associated with injecting the drug, it is important for a majority of the load path to travel through the forward shoulder 11 of the syringe barrel 12 and lesser load to pass through the flange 16 at the rear end thereof Thus, the syringe 10 of the cassette unit 1 additionally comprises a shoulder support feature 5 for supporting the forward shoulder 11 of the syringe. The shoulder support feature 5 may also used to adapt a 1ml syringe for use in the cassette unit 1. It supports the 1ml syringe shoulder 11, and transmits the load through to the same surface that would support a 2.25ml syringe shoulder directly.

The shoulder support feature 5 may be seen to comprise a split-barrel 6 that is sized and shaped for receipt by the syringe barrel 12 and a forward lip 7 that is arranged to locate in snap-fit fashion between the rigid needle sheath shell 19 and the forward shoulder 11 of the syringe 10. In embodiments, the use of such a shoulder support feature 5 is to adapt the smaller diameter 1ml syringe to the diameter of the 2.25ml syringe shoulder 11. Provision may also be made for poor dimensional control in the production of glass syringes.

Within the cassette unit 1, the shoulder support feature 5 for the syringe 10 interacts with the inner wall of the cassette unit housing 20, which thereby acts to constrain the position of the shoulder support feature 5 and syringe 10 within the cassette unit housing 20. The inner wall of the cassette unit housing 20 also prevents the forward lip 7 of the shoulder support feature 5 from flexing outwards when injection loads are applied to the syringe 10. Thus, the forward shoulder 11 of the syringe 10 effectively captures the forward lip 7 of the shoulder support feature. Also, the rearward split-barrel part 6 of the shoulder support feature 5 acts to sleeve a portion of the syringe barrel 12.

An additional consequence of this part-sleeved relationship between shoulder support feature 5 and syringe barrel 12 is to increase the effective diameter of the syringe barrel 12. By choice of different sizes, particularly inner diameters, of shoulder support feature 5 different syringe 10 sizes may be accommodated within the same cassette unit housing 20. Thus, the shoulder support 5 may also effectively be used as a syringe size adapter feature.

The syringe plunger 18 is provided with a plunger slaving part 60 that is axially movable within the syringe barrel 12 and for receipt by the rear end of the plunger 18. The syringe plunger 18 is made of a material that is resiliently compressible and the plunger slaving part 60 is made of a less compressible material, typically a rigid material.

The slaving part 60 may be arranged to be coloured and to perform a second function of providing an easy-to-identify visual indicator of the position of the plunger 18 within the syringe 10 so that the patient can visually confirm the drug had been fully injected. The flexible vanes 68 act such as to maintain the plunger slaving part 60 in the ‘after use’ (i.e. post-injection) position such that this indicator can be relied upon to signal this ‘after use’ state. In embodiments, the plunger slaving part 60 has a third function; one of tamper evidence: If an attempt is made to access the syringe 10 via the end-cap 40, the plunger slaving part 60 will be pushed out of engagement with the end-cap 40, resulting in visible evidence of tamper.

The cassette unit 1 includes, in capping relationship with a rear opening of the cassette unit housing 20, a cassette unit end-cap 40. The cassette unit end-cap 40 defines a drive rodreceiving opening 41 for receipt of a drive rod (part of the drive unit, not shown) for providing forward axial drive to the plunger slaving part 60. Four fixing legs 39 with heels locate at spaced intervals about the inner end wall of the end-cap 40 and protrude forwards for fixing receipt (not visible on Figure 13) with fixing sockets 29 of the cassette unit housing 20. In addition, fixing T-legs 38 with T-features locate at 180° spacing about the inner end wall of the end-cap 40 and protrude forwards for fixing receipt (not visible on Figure 13) with fixing T-sockets 23 of the cassette unit housing 20.

The cassette unit end-cap 40 also defines a spaced pair of cut-away apertures 51 (see Figure 1) positioned such that when the cassette unit end-cap 40 is in capped relationship with the cassette unit housing 20 the cut-away apertures 51 are in registration with the protruding arms 31 of the inner housing sleeve 30. Each cut-away aperture 51 is designed allow for insertion of a pushing member (e.g. a pin) such that forward pushing force may be applied to the top of the protruding arms 31 to push the inner housing sleeve 30 forward, thereby allowing for actuation of the shuttle lock control 32.

Figures 4 to 7 show a trainer cassette unit 101 of an auto-injector herein that is essentially identical in outward form to that of the prior art cassette unit 1 of Figures 1 to 3. The trainer cassette unit 101 is therefore suitable for safely training a user in how to use the prior art cassette unit 1 of Figures 1 to 3.

The trainer cassette unit 101 comprises an elongate form trainer cassette unit housing 120 having an end-cap 140. The inner housing sleeve 130 is further provided with security label 121, which may in aspects be an RFID tag label for use in verification purposes. In embodiments, the RFID tag label 121 has a tag that is programmed differently to RFID tag label 21 of the cassette unit 1, which contains a syringe 10 comprising drug formulation. In embodiments, when the tag label 121 is read a reader of the drive unit 70, the drive unit detects this different programming and prompts an additional screen, which is relevant to a training cassette 101 operation. In embodiments, when the drive unit 70 detects a training cassette 101 via the RFID tag label 121, it may also use different parameters for the leadscrew motor by referencing different values in a look-up table in the device database.

The trainer cassette unit 101 is provided with a removable cap 150 that is shown at Figures 4 to 6 in the capped position. In embodiments, the cap 150 and/or trainer cassette housing 120 of the trainer cassette 1 may be arranged to be of a different colour to the cap 50 and/or cassette housing of the cassette unit 1, so that a user may conveniently distinguish between them. The cap 150 is provided at the brim thereof with a peripheral arrangement of through-hole (i e socket like) first engagement features 152 (not visible on Figure 6). The cap 150 is shaped to define a ring pull 154 for receipt by the finger of a user. The gripping ring 154 of the removable cap defines a finger aperture to receive a patient's thumb or other preferred finger for pulling the removable cap away from the trainer cassette unit 101. The cap 50 is also provided with two axial guide channels 153 (spaced at 180° intervals, only one visible on Figure 7).

The trainer cassette unit housing 120 is provided with a radial arrangement of first engagement features in the form of movable locking legs 124 defining angled tips 125 thereon arranged for reversibly engaging the corresponding radial arrangement of second engagement features in the form of socket through holes 152 of the removable cap 150 for reversible lock engagement of the removable cap 150 to the trainer cassette unit housing 120. The trainer cassette unit housing 120 defines at its forward end an aperture 123.

The rear part of the inner housing sleeve 130 is provided with a spaced pair of rearward protruding arms 131. The inner housing sleeve 130 also forms a shuttle lock control feature 132 defining a radial arrangement of blocking elements 134 for selectively blocking movement of the movable locking legs 124 of the cassette unit housing 120 relative to the socket holes 152 of the cap 150, thereby providing for selective control of cap locking / unlocking, more details of which are described hereinafter with reference to Figures 8a to 11c. Return spring 135 is also provided.

The trainer cassette unit 101 includes, in capping relationship with a rear opening of the cassette unit housing 120, a cassette unit end-cap 140. The cassette unit end-cap 140 defines a drive rod-receiving opening 141 for receipt of a drive rod (part of the drive unit, not shown). Four fixing legs 139 with heels locate at spaced intervals about the inner end wall of the end-cap 140 and protrude forwards for fixing receipt with fixing sockets 129 of the cassette unit housing 120. In addition, fixing T-legs 138 with T-features locate at 180° spacing about the inner end wall of the end-cap 140 and protrude forwards for fixing receipt with fixing T-sockets 123 of the cassette unit housing 120.

The cassette unit end-cap 140 also defines a spaced pair of cut-away apertures 151 positioned such that when the cassette unit end-cap 140 is in capped relationship with the cassette unit housing 120 the cut-away apertures 151 are in registration with the protruding arms 131 of the inner housing sleeve 130. Each cut-away aperture 151 is designed allow for insertion of a pushing member (e.g. a pin) such that forward pushing force may be applied to the top of the protruding arms 131 to push the inner housing sleeve 130 forward, thereby allowing for actuation of the shuttle lock control 132, as described in more detail hereinafter.

Both the prior art cassette unit 1 and the trainer cassette unit 101 herein allow for selective control of cap locking / unlocking. Such selective control is now described in relation to the prior art cassette unit 1 by reference to Figures 8a to 11c. The mechanism for selective control of cap locking / unlocking of the trainer cassette unit 101 is identical in form and function to that of the prior art cassette unit 1. Thus for example, the inner housing sleeve 30 with shuttle lock control feature 32 defining a radial arrangement of blocking elements 34 of the prior art cassette unit 1 corresponds to the inner housing sleeve 130 with shuttle lock control feature 132 defining a radial arrangement of blocking elements 134 of the trainer cassette unit 1. All description herein provided in relation to selective control of cap locking / unlocking of the prior art cassette unit 1 therefore equally applies to the trainer cassette unit 101, and drawings essentially identical to Figures 8a to 11c could equally be provided for the trainer cassette unit 101 but with features labelled in the lOO’s (i.e. shuttle lock control feature ‘132’, instead of ‘32’).

For illustrative purposes only. Figure 8c shows the separate cassette unit housing 20 and shuttle lock control 32 parts of the part-assembly of Figures 8a and 8b.

The cassette unit housing 20 is provided with a radial arrangement of first engagement features in the form of axially protruding locking legs 24 having heels defining angled tips 25 having a chamfered edge 25a and movable by flexing action and arranged for reversibly engaging a corresponding radial arrangement of second engagement features in the form of socket through holes 52 of the removable cap 50 (see Figures 1 and 3) for reversible lock engagement of the removable cap 50 to the cassette unit housing 20. In a secondary aspect, this arrangement also acts to prevent rotation of the cap 50 relative to the cassette unit housing 20.

The inner housing sleeve 30 defines a shuttle lock control feature 32 comprising a radial arrangement of blocking elements 34 for selectively blocking inwardly flexing movement of the movable locking legs 24 of the cassette unit housing 20 relative to the socket holes 52 of the cap 50, thereby providing for selective control of cap locking / unlocking.

The shuttle lock control 32 is axially movable relative to the cassette unit housing 20 in between three positions, namely: (i) as shown at Figures 8a, 9a, 10a and 1 la, a first ‘cassette unused’ position, in which the blocking elements 34 block movement of the locking legs 24 of the cassette unit housing 20 relative to the socket through holes 52 of the removable cap, thereby keeping the removable cap 50 in locked relationship to the cassette unit housing 20; (ii) as shown at Figures 9b, 10b and 1 lb, a second ‘cassette unlocked’ position, in which the blocking elements 34 no longer block movement of the locking legs 24 of the cassette unit housing 20 relative to relative to the socket through holes 52 of the removable cap 50, thereby allowing for unlocking of the removable cap 50 from the cassette unit housing 20 and for removal and replacement thereof; and (iii) as shown at Figures 8b, 9c, 10c and 11c, after replacement of the removable cap 50, a third ‘cassette used’ position, locating intermediate the first and second positions, in which the blocking elements 34 again block movement of the locking legs 24 of the cassette unit housing 20 relative to the socket through holes 52 of the removable cap, thereby restoring the locked relationship between the removable cap 50 and the cassette unit housing 20.

Movement of the shuttle lock control 32 is typically achieved by application of forward pushing force to the top of the protruding arms 31 of inner housing sleeve 30 to push the inner housing sleeve 30 and the shuttle lock control 32 forward. This is typically achieved by insertion of a pushing member (e g. a pin) into each of the cut-away apertures 51 of the cassette unit end-cap 40 to push forward the protruding arms 31 of the inner housing sleeve 30. The shuttle lock 32 is biased by the action of shuttle lock spring 35.

The shuttle lock control 32 is further provided with a pair of diametrically oppositely located axial position locators 36, each of which is arranged to define three distinct axial positions of the shuttle lock control 32 relative to cassette unit housing 20 and corresponding to said first, second and third positions. Each axial position locator 36 comprises an axial protrusion having a follower 37 arranged thereon for receipt within a corresponding axial track 26 of the inner cassette unit housing 20 such as to define an axial track-follower relationship between the shuttle lock control 32 / inner housing sleeve and the cassette unit housing 20. The previously defined first and second positions correspond to the opposite extremes of this axial track-follower relationship.

In use, the cassette unit 1 is initially in the first ‘cassette unused’ position, in which the angled tip 25 of each flexibly resilient locking leg 24 of the cassette unit housing 20 protrudes slightly into a socket through-hole first engagement feature 52 of the removable cap 50. It will be appreciated that this engaging interaction of the angled tip 25 of locking leg 24 with socket through-hole feature 52 effectively prevents movement (including rotation) of the cap 50 relative to the cassette unit housing 20. In this first position, the blocking elements 34 block movement of the locking legs 24 of the cassette unit housing 20 relative to the socket through holes 52 of the removable cap, thereby keeping the removable cap 50 in locked relationship to the cassette unit housing 20.

In the second ‘cassette unlocked’ position, this engaging interaction can be released by pushing each locking leg 24 inwards, thereby clearing the angled tip 25 from engaging relationship with each relevant socket through-hole 52. Such inward pushing action on the locking leg 24 can be achieved (in the cap unlocked position of Figures 9b, 10b and 1 lb) by pulling the cap 50 forwards and away from the cassette unit housing 20, which results in the angled tip 25 interacting with the wall edges of the through-hole 52 to push the locking leg 24 inwards.

After cap removal and during injected use, the action of shuttle lock spring 35 results in adoption of the third position until such time as the removable cap 50 is replaced when the second position is again adopted during cap 50 replacement. After cap replacement, the third position is again adopted. The shuttle lock control 32 is arranged to be brought into registration with the indicator opening of the cassette unit housing 20 at the third ‘cassette used’ position (see Figure 8b) as a visual indicator that the cassette has been used.

The cassette unit 1 further comprises flexible locking arms 99, and trainer cassette unit 101 further comprises locking arms 199, for locking receipt within locking apertures of a cassette unit holder of a drive unit.

Figure 12 shows a drive unit 70 for use with the prior art cassette unit 1 or trainer cassette unit 101 described herein. The drive unit 70 comprises a drive unit housing 71 for housing a drive arrangement, which drive unit housing 71 is sized and shaped at its forward end for receipt of a prior art cassette unit 1 or a trainer cassette unit 101. Figure 13 shows the drive unit 70 having received a representative trainer cassette unit 101 at the docking position, wherein ring pull 154 of the removable cap 150 protrudes from the drive unit housing 71. The drive unit housing 71 is provided with a user-interface in the form of a screen 72, which may in embodiments be a touch-sensitive screen 72.

In embodiments, the drive unit 70 is arranged for sequential receipt of a trainer cassette unit 101 herein. Thus, in embodiments, the drive unit 70 is arranged for initial receipt of the trainer cassette unit 101 at an intermediate pre-docking position and for subsequent transport of the trainer cassette unit 101 to the docking position.

In embodiments, the drive unit 70 is arranged such that transport of the trainer cassette unit 101 to the docking position is permitted only following positive verification of the identifier 121. Thus, only appropriately identified trainer cassette units 101 are finally receivable into the device.

In embodiments, the drive unit 70 is arranged such that transport of the trainer cassette unit 101 from an intermediate position to a docking position is permitted only following positive verification of the identifier 121. Thus, only appropriately verified cassette units are finally receivable into the device for drug delivery there from. In embodiments, that transport of the trainer cassette unit 101 to the docking position is by automatic control under the action of the electrically powered source of drive.

It is to be understood that the foregoing description is merely illustrative and is not to be limited to the details given herein. While several embodiments have been provided in the present disclosure, it should be understood that the disclosed systems, devices, and methods, and their components, may be embodied in many other specific forms without departing from the scope of the disclosure.

Variations and modifications will occur to those of skill in the art after reviewing this disclosure. The disclosed features may be implemented, in any combination and subcombinations (including multiple dependent combinations and subcombinations), with one or more other features described herein. The various features described or illustrated above, including any components thereof, may be combined or integrated in other systems. Moreover, certain features may be omitted or not implemented. Examples of changes, substitutions, and alterations are ascertainable by one skilled in the art and could be made without departing from the scope of the information disclosed herein. All references cited herein are incorporated by reference in their entirety and made part of this application.

The application of which this description and claims form part may be used as a basis for priority in respect of any subsequent application. The claims of such subsequent application may be directed to any feature or combination of features described herein. They may take the form of product, method or use claims and may include, by way of example and without limitation, one or more of the following claims.

Claims

1. A trainer cassette unit for use with an auto-injector having an electrically powered drive unit, said trainer cassette unit comprising: a trainer cassette unit housing defining a cassette unit housing cavity and a forward projection aperture; and a removable cap that in a capping position fits over and thereby, acts such as to close off, the forward projection aperture of said training cassette unit housing, the training cassette unit housing being provided with one or more first engagement features arranged for reversibly engaging one or more second engagement features of said removable cap for reversible lock engagement of the removable cap to the cassette unit housing; and a shuttle lock control defining one or more blocking elements for selectively blocking movement of said one or more first engagement features relative to said one or more second engagement features; and an identifier, which identifies the trainer cassette as being for use in training operations.

2. A trainer cassette according to claim 1, wherein the identifier is an RFED tag.

3. An auto-injector comprising (a) a training cassette unit according to either of claims 1 or 2; and (b) a drive unit comprising a reader and a display screen, wherein the reader of the drive unit detects the identifier as indicating a trainer cassette and prompts display of information relevant to a training cassette operation on the display screen.