WO2003097141A2

WO2003097141A2 - Dispensing system

Info

Publication number: WO2003097141A2
Application number: PCT/GB2003/002084
Authority: WO
Inventors: Calvin Ross
Original assignee: Sirus Pharmaceuticals Limited
Priority date: 2002-05-15
Filing date: 2003-05-14
Publication date: 2003-11-27
Also published as: GB0311096D0; AU2003233996A1; GB0211163D0; GB2389316A

Description

DISPENSING SYSTEM This invention relates to systems and apparatus for use in patient care and in particular but not exclusively to dispensing metered doses of medicinal or therapeutic products . The invention in one aspect relates to a sublingual dispensing apparatus, but has application to other fields including inhalation delivery.

There are many instances in which a patient self- administers a dose of a product using a dispensing device under the direction of a physician and in which it is important to regulate use of the dispensing device on the one hand to avoid overdosing where the product is a potentially dangerous or expensive drug and on the other hand to ensure compliance with a regime of regular administration over time.

Lock-out mechanisms have been disclosed for example in US4934358 for preventing actuation of a metered dose inhaler other than in accordance with a predetermined dosing schedule. Devices such as metered dose inhalers, nebulisers and powdered drug inhalers are also disclosed in US 5284133 as being provided with a lock-out device and means for recording the time and dose of each delivery of medication.

The present invention seeks to provide improvements in such systems and devices with a view to providing a practical solution in a marketable product. In one aspect, embodiments of the invention provide a control device having a processor and which can be inserted into engagement with a dispensing device so as to be operable to control the manner in which the device is actuable during dispensing of drug doses to comply with a predetermined dosing schedule. Prior to insertion, the control device is configured with control data by placing the control device in communication with a system controller in a control system having a docking station in which the control device is insertable. After use, the control device may be removed from the dispensing device and again placed in communication with the system controller to download data stored in the control device relating to the history of use of the dispensing device.

In one arrangement, the dispensing device includes a drug reservoir such as a pressurised dispensing container and a power cell for energising electrically operated components of the dispensing device.

In an alternative arrangement, the power cell is included in the control device.

In a further alternative arrangement, both the power cell and the drug reservoir are included in the control device, suitable couplings being provided between the control device and dispensing device.

Embodiments of the invention include sensors responsive to physiological parameters or to the presence of substances used by the patient to provide indicators or measurements for use in controlling delivery.

Embodiments of the present invention will now be described by way of example only and with reference to the accompanying drawings of which:

Figure 1 is a schematic diagram of a dispensing device into which a control device is insertable, the dispensing device incorporating a pressurised dispensing container for dispensing a metered dose of a drug in aerosol form;

Figure 2A is a schematic side-elevation of the dispensing device of Figure 1;

Figure 2B is a schematic plan view sectioned at line A-A of Figure 2A;

Figure 2C is a schematic front elevation of the device of Figures 2A and 2B;

Figure 2D is a schematic side view of the pressurised dispensing container of preceding figures;

Figure 2E is a part sectioned elevation of an alternative dispensing device;

Figure 3 is a schematic diagram showing the functional elements of the control device of preceding figures; Figure 4 is a schematic diagram of a system for patient care using a control system in conjunction with the dispensing device and control device of preceding figures;

Figure 5 is a graphical representation of dosing events constrained by a predetermined dosing schedule;

Figure 6 is a schematic representation of a user interface for use in the system of Figure 4;

Figure 7 is a flowchart illustrating a program to control dosing events;

Figure 8 is a schematic diagram of an alternative dispensing device in which the control device includes a power cell for energising the dispensing device;

Figure 9 is a schematic diagram of a further alternative dispensing device in which the control device includes a drug reservoir;

Figure 10 is a schematic diagram of a further alternative dispensing device in which the control device includes a metering chamber and the dispensing device includes a sensor responsive to substances in the body fluids of the patient;

Figure 11 is a schematic sectional view showing the typical external shape of the embodiment of Figure 10; Figure 12 is a sectional view of a housing and applicator of a dispensing device having sensor elements for engaging the lips of the patient.

Figure 13 is a plan view of the apparatus of Figure 12;

Figure 14 is an underneath view of the apparatus of Figure 12;

Figure 15 is a flowchart illustrating the method of operating the apparatus of Figure 10;

Figure 16 is a schematic diagram of a further alternative dispensing device having physiological parameter sensors;

Figure 17 is a schematic illustration of a mechanical interlock between a control unit and dispensing apparatus;

Figure 18 is a schematic diagram of a dispensing device having a security device in the form of a keypad; and

Figure 19 is a schematic circuit diagram of a power cell depletion circuit.

Figure 1 illustrates a dispensing device 1 into which a control device 2 is removably inserted so as to engage an electrical connector 3 of the dispensing device.

The dispensing device 1 contains a pressurised dispensing container 4 which contains a sealed quantity of drug in liquid form together with a propellant, the container having a valve mechanism actuated by depression of the valve stem 5 relative to the container to release a metered dose of drug to be dispersed in aerosol via a nozzle 6.

An applicator 7 formed of a moulded plastics material is arranged to guide the aerosol to its delivery target.

A mechanical actuator 8 is arranged to be moveable relative to a housing 9 of the dispensing device 1 such that user movement of the actuator causes the pressurised dispensing container 4 to be engaged by the actuator and moved towards the nozzle 6 to provide relative movement between the container and valve stem 5, thereby initiating the dispensing of a metered dose. The housing 9 is similarly formed from a moulded plastics material.

The position of the actuator 8 is sensed by actuation sensor 10 which is connected to the control device 2 via the electrical connector 3 so as to deliver sensor signals representative of movement of the actuator 8 to an initial position 11. This is interpreted by the control device 2 as an actuation request signal which indicates that the user is attempting to actuate the dispensing device 1. If the attempt is successful, the movement continues to an advanced position 12, resulting in the actuation sensor generating further a sensor signal representative of the actuator 8 being fully displaced, the advance position 12 being reached only when the pressurised dispensing container has actually been actuated. This further signal is interpreted by the control device as a dosing event.

A locking mechanism 13 is provided for preventing actuation of the pressurised dispensing container 4 unless released by an electrically powered lock actuator 14 being energised under the control of the control device 2 to which it is connected via the electrical connector 3.

In Figure 1, the locking mechanism 13 engages a lower edge of the pressurised dispensing container 4 to prevent relative movement between the container and the nozzle 6. Lost motion between the actuator 8 and container 4 allows movement of the actuator to the initial position 11 without movement of the container. An alternative configuration is indicated by reference 15 which shows in broken lines the position of an alternative locking mechanism which acts directly on the actuator 8 to selectively prevent its movement beyond the initial position 11.

A power cell 16 for energising the lock actuator 14 is located in the housing 9 and connected to the control device 2 via the electrical connector 3.

A status indicator 17 in the form of an LED display is also provided on the housing 9 for indicating to the user whether or not the dispensing device 1 is available for use, or more specifically, whether the request for actuation is allowed by the control device 2.

Figure 2A illustrates schematically the external features of the dispensing device 1 of Figure 1 in which the housing 9 has a main tubular body 20 closed at one end by the actuator 8 in the form of a cap which is captively retained on the tubular body and relatively moveable thereto in order to provide movement for actuation of the pressurised dispensing container 4.

The tubular body 20 has a second open end to which the applicator 7 is attached as a snap fit so as to be removably connected and replaceable. This allows replacement of the applicator by different forms of applicator for different purposes. Alternatively, a replacement applicator of the same type may be fitted if the dispensing device is re-used by a different patient. In Figure 2A, applicator 7 is illustrated as being a mouthpiece for delivery to the user's mouth as a topical application of the drug.

Figure 2B illustrates schematically in plan view sectioned at A-A the location of the pressurised dispensing container 4 and power cell 16 within the tubular body 20. The control device 2 is also visible in Figure 2B, the control device being card shaped and seen end-on, being located within a card slot 21.

Figure 2C shows in front-elevation the dispensing device 1, showing detail of the nozzle 6 which has an array of seven outlet apertures arranged for delivering a low velocity aerosol spray via an outlet port 23 defined by the applicator 7.

Figure 2D illustrates the appearance of the pressurised dispensing container 4 which comprises a glass vial having a cylindrical glass wall 24 covered in a synthetic coating 25 to protect the glass vial against shattering and splintering. Importantly, the coating 25 acts to prevent the user from being injured in the event of the bottle being broken. The glass vial is of a type disclosed in US5979714

The synthetic coating 25 is provided with pressure relieving openings 26 for permitting the rapid pressure release in the event of the shattering of the glass vial.

The housing 9 and actuator 8 are formed of high strength plastics materials which are resistant to breakage and form a tamper resistant enclosure for the container 4. The container 4 has inherent tamper evident features by virtue of its glass vial structure since any attempt to gain access to the liquid contents other than by valve actuation will result in explosive shattering of the vial, thereby making recovery of the contents difficult.

Figure 2E illustrates an alternative form of housing in which the cap 8 of Figure 2A is replaced by a rigid non- moveable end closure 27, an access opening 28 being provided in the tubular body 20 to allow the user to manually depress the container 4. In this arrangement, the actuation sensor 10 is located at the nozzle end of the container 4 to sense initial and final movement positions 11 and 12 of the container relative to the nozzle 6. Figure 3 illustrates schematically features of the control device 2. The control device 2 has a processor 30 connected via a bus 31 to a ROM (read-only memory) 32 and RAM (random access memory) 33. A clock 34 is also connected to the bus 31 together with a signal interface 35 and an actuator control circuit 36. The processor and clock are powered by an on-board power source 38.

The signal interface 35 receives an actuation request signal 39 from the actuation sensor 10 and, upon sensing that the user wishes to actuate the dispensing device 1, the processor 30 determines whether actuation is permitted by operation of a control program 300 and control data 301 stored in RAM 33 and with reference to a time signal obtained from clock 34.

If actuation is to be permitted, an actuating signal 37 is output from actuator control circuit 36 for energising the lock actuator 14 and thereby releasing the locking mechanism 13. Actuation by movement of the actuator 8 (or manual actuation of the container of Figure 2E) to its advanced position 12 is then possible. This movement is further sensed by the actuation sensor 10 and a resulting dosing event signal received by the signal interface 35. The signal is interpreted as representing the delivery of a dose and this dosing event data is recorded by action of the processor 30 in a database 302 held in RAM 33. The dosing event data recorded in the database 302 indicates the time at which the dose was delivered.

Figure 4 illustrates schematically the manner in which the control device 2 can be configured so as to operate in accordance with the required control program 300 and using appropriate control data 301. Before being presented to the dispensing device 1 , the control device 2 is received in a docking station 40 in which electrical connection is made via an electrical connector 47. The docking station 40 is connected to a personal computer 41 programmed with a user interface program which allows a physician or other operative to configure the control data 301 stored in the control device 2. The docking station 40 and personal computer 41 therefore constitute a control system 48 for supervising and monitoring patient drug use.

After use of the dispensing device 1 under the control of the control device 2 , the control device 2 may be removed and re-inserted in the docking station 40 to allow the data held in the database 302 to be downloaded to the personal computer 41 for analysis. Figure 4 illustrates also the option of connecting the docking station 40 via a modem 42 to a remote station 43 via a network 44 such as the internet or telephone network. In this arrangement, the control system is constituted by the docking station 40 and remote station 43 so that programming and transfer of control data and dosing event data may be performed at the remote station 43 in a similar manner to operations performed using the local personal computer 41.

Figure 5 illustrates how data representative of dosing events is processed in a typical control program. The status of the control device 2 is indicated graphically by levels , S and L corresponding to states defined below. Initially, the control device 2 is in a standby condition S in which the lock actuator 14 is not energised and the locking mechanism 13 prevents actuation. The detection of an initial dosing event 50 defines the start of a window during which the control device 2 is in an open-window state W. The maximum duration of the window period is set, by the control data 301 defining a value t_w which in this example is 15 minutes. The control data 301 also includes a value of N defining the maximum number of events within each window period t_w. In this example N = 4. Successive dosing events are recorded and counted, the running total n being recorded. If n reaches N, no further dosing events are permitted within the existing window and the system enters a locked state L.

If n does not reach N, the end of the window period t_w determines the start of the lock-out period t_L during which the system is in a lock-out state L, the value of t_L being configured in the control data 301. No dosing events are permitted in the lock-out state.

After the elapse of t_L the system returns to standby state S until a further actuation request attempt results in a dosing event 51 and defines the start of a further window. The above process is repeated with n being reset to 0.

The cumulative number of events is also logged as m and, before any dosing actuation is permitted, m is compared with a value M which is the total number of doses permitted to be dispensed, this being configured in the control data 301 by the value of M.

In the example of Figure 5, there are three dosing events in an initial window commencing with event 50 so that the duration of the window reaches its maximum allowable extent of t_w. A second window commencing with dosing event 51 however contains four events, equal to the maximum permitted number N, so that the window is truncated by the early start of the lock-out period.

At each attempted actuation by the user, the actuator 8 is initially advanced to initial position 11 and, if the control program determines that actuation is allowed, a green LED of the status indicator 17 is lit so that the user is invited to proceed. If however the control program determines that actuation is prohibited, a red LED of the indicator 17 is illuminated, indicating to the user that actuation will be prevented by the locking mechanism 13.

Figure 6 illustrates schematically the data fields presented in the user interface of personal computer 41 or 43. Data fields are available for patient identification, drug identification, dose size, and values of window period, lock-out period, maximum number of events within each window N and maximum number of doses to be dispensed M. Required values of these parameters may be entered using a keyboard of the computer 41 or 43. Figure 7 illustrates steps of the method controlled by the processor 30 in accordance with computer program instructions stored as control program 300 in RAM 33. As illustrated schematically in Figure 4, the computer program 300 may be downloaded to the personal computer 41 from a portable storage medium such as a floppy disk 45 or may be received as a signal 46 over a communications channel which may for example be provided by a network 44 such as the internet. The program 300 may then be downloaded via the docking station 40 to be stored in the control device 2.

The computer program 300 may alternatively be pre- installed at manufacture in RAM 33 or ROM 32.

The values of n and m are initialised at step 70 to n=m=0 and the control device 2 operates in the standby state S at step 71, operating in a low power consumption mode sufficient for clock 34 to maintain operation.

When a user initiates actuation by depressing actuator 8 to the initial position 11, an actuation request signal 39 is received at step 72 by the control device 2 which responds by operating the processor 30 in accordance with the computer program to determine whether or not the dispensing device 1 is to provide actuation. This is represented in Figure 5 and Figure 7 as entering the window state W in which actuation is to be permitted during a window of maximum duration t_w.

Following detection of the actuation request at step 70, the processor 30 controls the indicator 17 to provide an indication that actuation is permitted, such as for example by energising a green LED, and at the same time controls the lock actuator 14 to release the locking mechanism 13 at step 74.

If at step 75 complete actuation is sensed, for example by receiving a sensor signal indicating that the actuator 8 of Figure 1 has travelled to the advanced position 12, the values of n and m are incremented by 1 and the dosing event is recorded in database 302 at step 76.

The processor 30 then controls the lock actuator 14 to close the locking mechanism 13 at step 77.

At step 78, the processor determines whether the value of n has reached the value N and, if so, the lock-out state L is entered at step 81. If however n is smaller than N, the value of m is compared with M at step 79. If m = M then the processor controls the device to enter into a sleep mode at step 82 in which no further actuation is possible.

Otherwise, it is determined at step 80 whether any further actuation request is received during the current window period t_w. If a further actuation request has been received, the processor indicates that actuation is permitted and releases the lock, the process being repeated from step 74 described above.

If however no further actuation requests are received during the window, step 81 follows in which the lock-out state is entered. After waiting for the end of the lock- out period t_L at step 84, n is reset to 0 at step 85 and the standby state S is resumed to repeat the process from step 71.

Figure 8 illustrates an alternative embodiment which will now be described using corresponding reference numerals to those of preceding figures for corresponding elements where appropriate. Figure 8 illustrates a dispensing device 1 in combination with a control device 2 which differs from the arrangement of Figure 1 in that the power cell 16 for energising the dispensing device is formed integrally with the control device and powers the dispensing device via the electrical connector 3.

Figure 9 illustrates a further alternative embodiment which will be described using corresponding reference numerals to those of preceding figures where appropriate. The embodiment of Figure 9 comprises a dispensing device 1 which is engageable with a control device 2 which includes both a power cell 16 and a drug reservoir 90. When the control device 2 is engaged with the electrical connector 3, the reservoir 90 is at the same time engaged by a coupling 91 for placing the contents of the reservoir in communication with a supply duct 92. In the case of a liquid drug, the coupling may comprise an elastomeric septum 96 forming a sidewall of the reservoir 90 and which is penetrable by a hollow needle 97 provided in the coupling 91. The septum 96 may be self-healing so that liquid is not lost when the control device 2 is subsequently removed. A dispensing mechanism 93 controlled by an electrically operated actuator 94 allows doses of the drug to be dispensed via the supply duct 92 from the reservoir 90 into a delivery duct 95. The delivery duct 95 communicates with an applicator 7 for applying the drug in the appropriate manner and may for example comprise a mouthpiece for inhalation therapy. The control device 2 of Figure 9 is programmed and configured with control data 301 in the manner described above with reference to the embodiment of Figure 1 but is typically supplied as a disposable item containing a predetermined number of doses within the reservoir 90. The control device 2 may be configured for a specific patient by selection of an appropriate set of control data 301 and, if necessary, by selection of a preferred control program 300. In the specific example of Figure 9, actuator 8 is a breath actuator which generates an input signal to the control device 2 when inhalation through the delivery duct 95 is sensed. This signal corresponds to the actuation request signal referred to at step 72 in Figure 7 and in response to which the control device 2 will determine whether or not to permit a dose to be dispensed. If a dose is to be dispensed, the dispensing mechanism 93 is actuated by energising the actuator 94 to release a metered dose of the drug into the delivery duct 95 via the supply duct 92.

In one example, the drug is in liquid form and the dispensing mechanism 93 is a micro-pump. In a further example, the drug is in powder form and the dispensing mechanism 93 is a piezo-electric device for agitating the powder so as to be displaced into the airflow within the delivery duct 95. Metering of powder in such devices may be effected by using separate compartments within the reservoir 90 which are accessed by penetrating compartments at successive actuations of the dispensing device 1.

Figure 10 illustrates a further alternative embodiment which will be described using corresponding reference numerals to those of previous embodiments where appropriate for corresponding elements. In this embodiment, the control device 2 has the form of a slim, generally rectangular package so as to resemble as far as practicable a credit card. The control device 2 is therefore highly portable.

The control device 2 includes a reservoir 90 which is itself of slim rectangular form and constructed of a glass envelope covered with a synthetic coating to guard against shattering and splintering and with an elastomeric septum 96 providing access to a metering chamber 100 for dispensing metered volumes of fluid from the reservoir. In Figure 10, the septum is shown as being located in a sidewall of the reservoir but may alternatively be located in an end face of the reservoir which is the same end face which is received in the connector 3.

As indicated by arrow 101, the control device 2 is removably mountable relative to the dispensing device 1 of Figure 10 and, when mounted with the dispensing device, electrical connection is made via the electrical connector 3 of the dispensing device so that components as shown in Figure 3 contained within the control device 2 both energise and control operation of the dispensing device.

The control device 2 includes a power cell 16 for energising the dispensing device 1.

In the coupled position in which the control device 2 and dispensing device 1 are connected, a valve stem 102 of the dispensing device 1 is moved into penetrating engagement with the elastomeric septum 96 and is axially displaceable by an actuator 94 to obtain release of fluid from the metering chamber 100 at each actuation.

Control of actuation is effected in a manner corresponding to preceding embodiments in which processor

30 is provided with appropriate control program 300 and control data 301, the dosing history being stored in database 302 .

The control device 2 has connectors and dimensions compatible with use in a conventional smart card reader so that, as shown in Figure 4, the control device may be used with a docking station 40 in the form of a smart card reader, this being appropriate when it is required to program the control device with new software or data or when it is required to download contents of the database.

The control device also includes an identifier 103 for uniquely identifying the control device so that, for example, a one to one relationship may be established between a given control device and a given patient. The identifier 103 in the example of Figure 10 comprises machine readable indicia applied to an external surface of the control device 2 such that the indicia may be read by locating the card in an appropriate reader. The identifier 103 may for example comprise a magnetic strip encoded with a unique digital sequence or may comprise a barcode. Alternative embodiments are envisaged in which a microchip is used for the identifier 103, the microchip being encoded with a unique identifier which can be read by placing the control device in an appropriate microchip reader.

An electrical switch 104 of the dispensing device 1 is accessible to the user to generate an actuation request signal. Whether or not a dispensing actuation is permitted by the control device 2 is determined using a control program 300 as indicated in Figure 7 using control data 301 configured in the control device prior to coupling the control device with the dispensing device 1.

In Figure 10, the dispensing device 1 is represented only schematically in that the housing 9 has a first portion 105 containing the electrical connector 3 for mating with the control device 2, the actuator 94 and switch 104. A second portion 106 of the housing 9 defines a conduit communicating with an applicator 7 which in this example is suitable for sublingual delivery. The applicator is removably connected to the second portion 106 by snap fit connecting formations (not shown) to allow different types of applicators to be selectively used.

In use, the patient presents actuator 7 to their mouth in an appropriate position. If the applicator 7 is for sublingual delivery, the end of the applicator is directed beneath the patient's tongue. When actuation is requested by the user pressing switch 104 and the request is granted by the processor 30, actuator 94 causes the metering chamber to be opened by valve action. An aerosol of the formulation to be dispensed is thereby released so as to be conducted via a delivery tube 107 into the second portion 106. Delivery then takes place via the applicator 7 which directs the aerosol into the patient's mouth.

The applicator 7 includes on its external surface a sensor 108 which is electronically connected to the control device 2 via the electrical connector 3. Conductors providing connection between the applicator 7 and connector 3 are provided with contacts for making and breaking connection when the applicator is connected to and removed from the second portions 106 of the housing 9. Signals from the sensor 8 are processed in the control device 2 to obtain one or more parameter values. Signals are derived by applying an electrical potential across a portion of plastics material constituting an element of the sensor to measure its resistance. The decision as to whether to provide actuation to deliver a dose in response to a user request may be made conditional on one or more such parameter values or upon the outcome of a judgement process in which one or more parameter values affect the outcome of the judgement.

The sensed signals from the sensor 108 may also be stored in the database 302 for later downloading and analysis.

The sensor 108 comprises a pair of elements of a plastics material arranged to contact upper and lower lips of the patient and forming a structural part of the applicator 7. Alternatively the elements may be mounted on the applicator 7 so as to be bonded to and supported by the structure of the applicator. The sensor elements may be fabricated as insert mouldings in the applicator. The plastics material of the sensor 108 has embedded electrodes for the extraction of sensor signals, the plastics material being porous and impregnated with a reagent selected to have properties which are dependent upon conditions created by contact with the patient. In a first example, the sensor 108 is responsive to saliva which comes into contact with the applicator and sensor during sublingual delivery, the sensed parameter being a physiological parameter such as pH or the presence of an enzyme. In a second example, the sensor 108 may be sensitive to the presence in saliva of substances used by the patient, including for example cannabis, alcohol and nicotine. Further alternative applicators may be responsive to different body fluids according to the type of delivery required.

The resulting parameter values obtained by processing the output of the sensor 108 may be used to control whether or not actuation is permitted. Alternatively, the control program 300 may be selected to make the decision as to whether to provide actuation independent of the parameter values but may choose to simply store the parameter values in the database 302 so as to provide additional information during later analysis of the database contents as a basis for reviewing and adjusting the dosing regime.

For example, where the dispensed formulation is a substitute for an addictive drug, the sensor 108 may be chosen to be selective and responsive to the presence of the addictive drug and further therapy by substitution may be made conditional on the patient ceasing to use the addictive drug. In response to sensing the presence of the addictive drug, the program 300 may deny further doses of the formulation to be dispensed. In effect, this provides a permanent lock-out.

Other applications include sensitivity to changes in saliva caused by the onset of migraine or episodes of Parkinson's Disease which are known to change the pH of saliva.

The plastics material is selected to have porous properties and preferably in plyolefine. The material is impregnated with a reagent appropriate to the required body fluid test, for example by using a reagent for sensing the present of thebaine when the test is required to detect use of opiates. To detect use of cannabis, a reagent for detecting THC (tetrahydrocannabinol) is appropriate. For pregnancy testing, sensitivity to ethinyloestradiol is appropriate.

A further embodiment of the present invention consists of the apparatus of Figure 10 modified to include a sensor 108 which does not have electrical contacts and does not have conductors connecting the sensor with the connector 3. In this embodiment, the sensor is composed of elements which change colour as an indicator of activation of the reagent in response to detecting a target substance. Appropriate action may then be taken either by the patient or by the prescribing professional to modify the dosing regime accordingly. The patient for example may be required to return the dispensing apparatus periodically for inspection so that the colour of the actuator can be used to provide an indication of whether the target substance has been detected.

The use of colour change sensors may be applied to applicators in dispensing devices containing conventional pump sprays or pressurised dispensing containers. For an example, a conventional meters dose inhaler or sublingual delivery device comprising a pressurised dispensing container contained in a plastic housing with a detachable applicator may be modified in accordance with a further embodiment to include sensor elements responsive to substances contained in the user's saliva and positioned for lip contact on the applicator. Colour change of the sensors may be taken as an indicator either by the patient or prescribing professional as to how to modify the existing dosing regime.

A still further embodiment comprises the arrangement as described with reference to Figure 10 but not including any of the sensors associated with the applicators. Figure 11 illustrates the general appearance of an embodiment corresponding to the schematic drawing of Figure 10. In Figure 11, the housing 9 has a shape similar to that of a pen with control device 2 forming an upper end portion when connected thereto. The control device 2 has contacts 114 for connection with a smart card reader. A membrane display 115 connected to the power cell 16 indicates the state of charge of the power cell 16, the display comprising a label applied to the external surface of the housing 9 and having an appearance which progressively changes with the state of charge to provide a visible indication to the patient. The patient is therefore made aware of how much further usable life of the power cell remains.

A reservoir 90 contains a quantity of formulation to be dispensed and a metered dose chamber 116 communicates with a delivery duct 117 for dispensing via nozzle 118.

An applicator 7 suitable for sublingual delivery receives and directs an aerosol spray of droplets 119 into the mouth of the user whose lips engage and contact an outer surface of the applicator 7 which carries first and second sensor elements 108A and 108B positioned to contact upper and lower lips respectively. Other forms of applicator may interchangeably be fitted to the housing 9.

Figure 12 illustrates the location of the sensor elements 108A and 108B relative to the housing 9 when the dispensing device 1 is of the type shown in Figure 1. In Figure 1, the sensor 108 is illustrated in broken lines to indicate that it is an optional feature, the option of including the sensor being accompanied by corresponding changes to the control program in the manner described above with reference to Figure 10. Similar comments apply to the inclusion of sensor 108 in the embodiment of Figure 8 and 9.

In the embodiments of Figure 1 and Figure 12, dispensing requires actuation of a pressurised dispensing container 4 (not shown in Figure 12). The housing 9 within which the pressurised dispensing container is axially slidable is illustrated in Figure 12 which has an applicator 7 carrying a sensor 108 comprising upper and lower sensor elements 108A and 108B respectively.

The housing 9 is viewed in plan in Figure 13 where the generally triangular shape of the upper sensor element 108A is visible, Figure 14 providing an underneath view in which the corresponding triangular shape of the lower sensor element 108B is visible. Electrical contacts with the sensor elements 108A and 108B are made at contacts 109A and 109B respectively whose general location is shown in Figures 13 and 14.

Figure 15 illustrates the method steps in a method of utilising the signal from sensors 108 comprising elements 108A and 108B.

Step 150 represents a wait state prior to receiving a patient's request for actuation. At step 151, actuation of the user switch 104 is detected by the control device 2. The sensor 108 is interrogated electronically to receive sensor signals at step 152 and parameter values are calculated from the sensor signals at step 153.

The calculated parameter values are stored in the database 302 at step 154 and at step 155 a threshold comparison is made as to whether the parameter values are within permissible range for allowing a dose to be delivered to the patient.

At step 156, if it is determined that a dose can be delivered according to the measured values of the parameters, the dosing history is examined in a manner corresponding to the method illustrated with reference to the flowchart of Figure 7 to determine if it is appropriate to allow further actuation to proceed at the present time. If the dose schedule allows a dose to be delivered, the control device 2 causes the dispensing device 1 to be released to an unlocked state and allows actuation to proceed, providing if appropriate the necessary energising signal to cause actuation to occur at step 157. Details of the dispensed dose are then stored in the database 302 at step 158.

If at step 156 or 155, it is determined that dispensing of the dose should not proceed, it is indicated at step 159 that actuation is not permitted, using appropriate actuation of the status indicator 17 as shown in Figure 1 (not shown in Figure 10).

Figure 16 illustrates schematically a further embodiment which will be described using corresponding reference numerals to those of preceding figures where appropriate for corresponding elements.

Figure 16 shows a dispensing device 1 controlled by control device 2 and having a delivery system 110 for the delivery of a drug dose to a user, the delivery system utilising a micropump 102 for dispensing metered quantities of formulation from reservoir 90. The control device 2 may correspond to the control device of Figure 1 or may additionally include a power cell 16 as shown in Figure 8, and includes the drug reservoir 90 as shown in Figure 9. The control device 2 is received in electrical connector 3 which is coupled via coupling 113 to body sensors including a temperature sensor 111 and a glucose sensor 112 for sensing the level of blood glucose in the user. A processor 30 of the control device 2 controls actuation of the delivery device 110 in accordance with a predetermined control program 300 and in accordance with configuration data 301 entered into the memory 33 of the control device 2 during a program phase prior to insertion of the control device into engagement with the connector 3.

The control program 300 also processes input signals from the sensors 111 and 112 and adjusts the dose if appropriate, thereby utilising the sensor signals as feedback signals.

Values of the sensed signals may also be stored in the database 302 of memory 33 in the control device 2 for later analysis.

Figure 17 illustrates an alternative arrangement which has application to the dispensing device 1 and control device 2 in any of the described embodiments, a mechanical interlock 120 being operable between the connector 3 and control device 2 so as to allow insertion of the control device but to prevent subsequent withdrawal or disconnection. Such an arrangement is appropriate where the dispensing device 1 and control device 2 together form a disposable unit. The control device 2 can be pre-programmed and may receive configuring data 301 for a particular user prior to insertion into engagement with the connector 3 , thereby defining the dosing regime under which the dispensing device 1 is to be used.

In the example of Figure 17, the mechanical interlock 120 utilises a resiliently deformable wall 121 of the connector which is shaped to define a cam surface 122 which is engaged by the control device during insertion so as to outwardly deform the wall. A cooperating groove 123 allows the wall 121 to relax into a locked position once the card is fully inserted in the connector and is shaped to prevent subsequent withdrawal of the control device 2 .

The mechanical interlock 120 may alternatively be constituted by any other form of snap fit connection, electro-mechanically actuated lock, or equivalent means for preventing withdrawal of the control device 2 once inserted in the card slot 21 into engagement with the connector 3.

Figure 18 illustrates schematically a dispensing device 1 controlled by a control device 2 and having a security device 130 mounted on the housing 9. Other details of the dispensing device 1 are omitted from the drawing to improve clarity, it being intended that the structure of any one of the embodiments described herein could be used for the dispensing device of Figure 18.

In the example illustrated, the security device 130 is a keypad for the input of a security code such as a PIN number allocated to the user to facilitate his personal use of the dispensing apparatus in conjunction with the control device 2. The PIN number is stored in the control device 2 as part of the control data 301. At each actuation, the user is required to enter the security code which must be verified by the processor 30 of the control device 2 before any actuation request is determined to be valid. This step may for example be included in step 72 described above in Figure 7 and in step 80, failure to verify the PIN number resulting in the actuation request being ignored.

Multiple users of the same dispensing device 1 of Figure 13 may be allocated different security codes, thereby enabling the processor 30 to distinguish between different users of the device and allowing the processor 30 to control use of the device accordingly.

The processor 30 may also recognise an additional security code allocated to a physician, operative or maintenance engineer. Alternative forms of security device 130 may be utilised, including a smart card reader for receiving a smart card carrying an identity code of the user, or alternatively any other form of electronically identifiable token.

Figure 19 illustrates a further alternative arrangement which may be incorporated in any of the disclosed embodiments. The power cell 16 for powering the dispensing device may be rendered inoperable by depleting the power stored in the cell using a power depletion circuit 141. This may be useful when it is desirable to prevent any further use of the dispensing device 1. In Figure 19, the cell depleting circuit 141 is actuated by a sensor 140 which responds to withdrawal of the control device 2 from the dispensing device 1. The sensor 140 may for example be built in to the connector 3 or may be a circuit responsive to changes in voltage level consequent to removal of the control device 1 from the connector 3.

In those embodiments in which the power cell 16 is located in the dispensing device 1, the dispensing device is thereby rendered inoperable once the control device 2 has been removed. This enhances the tamper resistant properties of the dispensing device 1.

In those embodiments in which the power cell 16 is housed in the control device 2, this feature prevents the control device 2 being inserted into a different dispensing device 1 for inappropriate use.

The embodiments of the present invention may be used in a number of drug therapy applications. In one example, the embodiments provide a disposable delivery method for potent drugs of abuse during therapy to facilitate withdrawal from addiction. Another example is administration of powerful drugs to relieve pain. In each case, the embodiments provide effective ways of regulating the timing of self-administration of doses of the drug, recording the dose delivery history, and thereby ensuring compliance with the instructions from a physician.

Although the described embodiments refer to dispensing devices having specific forms of drug delivery, the features of the embodiments are equally applicable to a range of types of delivery for which a non-exclusive list includes a syringe pump, peristaltic pump, displaceable membrane pump, a nebuliser, powder inhaler, and an anaesthetic vaporiser.

The described embodiments refer to a visible status indicator 17. Alternative forms of status indicator may be utilised for example an audible status indicator in place of, or in combination with, a visual status indicator which may comprise a simple LED display or a more complex display of text instructions.

The pressurised dispensing containers referred to in some of the embodiments are arranged for inverted delivery, i.e. the valve is lowermost such that the nozzle is positioned beneath the volume of liquid. This arrangement has the advantage of avoiding the need for a dip-tube and therefore providing more reliable priming for each metered dose. Alternative arrangements may be appropriate for certain forms of delivery, especially nasal delivery, where it is desirable for the applicator to be uppermost. In this arrangement, the valve and valve stem are uppermost and the container will therefore require a dip-tube to deliver liquid to the valve and nozzle.

Applicators of different types may be fitted to the same body 9. The form of connection may a snap-fit connector as described above or may alternatively be a permanent fixture such as by ultrasonic welding. Different forms of applicator may be selected from a number of alternatives, a non-exclusive list of which includes a sublingual applicator, a nasal applicator, a mouthpiece applicator for inhalation, and a topical applicator.

The applicators may include a part of the nozzle in order to modify the speed of delivery of the spray, for example by including a nozzle with several openings to disperse at low speed the resulting spray for delivery to the mouth area or a single nozzle opening for higher speed delivery for inhalation therapy.

Low speed spray may also be produced by using a baffle plate arranged such that the dispensed spray impacts upon the baffle plate before being deflected into the bore of the applicator.

Different forms of propellant may be selected for the pressurised dispensing container according to the intended use. For example, 134A propellant at high pressure may be used for inhalation therapy and butane propellant at low pressure may be used for oral forms of delivery.

The drug may be dispensed in preparations which include moisturising additives to moisten the mouth of the user, such additives for example including pineapple and lanolin preparations.

A control device 2 may be reprogrammed with new control data to suit changes in patient conditions. This is applicable to a control device 2 which is removable from the connector 3 and which can therefore be placed in the docking station 40. The physician or operative may then access the control data 301 via the user interface provided by software in the personal computer 41 or 43 as illustrated in Figure 4. The computer may store a database of patient records for a number of patients so that the reprogramming process may include the step of selecting the appropriate patient records based on an identifier stored in the control unit 2.

The control unit 2 may be provided with sufficient memory 33 to constitute a patient record in which the history of treatment over an extended period of time may be recorded, including dispensing of drugs from a variety of different dispensing devices 1 in which the control unit is inserted to provide the appropriate form of delivery.

In the above described embodiments which include an applicator having a sensor in which a porous plastics material is impregnated with a reagent, variation in the properties in the reagent may be sensed by means other than sensing the resistivity of the plastics material so impregnated. For example, the acoustic properties of the plastics material may be sensed using an appropriate electro-acoustic transducer such as a piezo-electric device. Where the control unit 2 is operated by control of a processor, the method of operation is determined by a computer program. An aspect of the present invention thus provides a storage medium storing processor implementable instructions for controlling a processor to carry out a method as described above.

Further, the computer program can be obtained in electronic form for example by downloading the code over a network such as the internet. Thus in accordance with another aspect of the present invention there is provided an electrical signal carrying processor implementable instructions for controlling a processor to carry out the method described above.

Similarly, computer programs for controlling the user interface and database access at the docking station constitute aspects of the invention embodied as a storage medium or electrical signal.

According to a further embodiment of the invention, a dispensing apparatus comprises a housing containing a dispensing mechanism for dispensing a dose of a product as an airborne aerosol or spray and an applicator for guiding the delivery of the dose. The applicator comprises one or more sensors of a type described above and comprising a reagent which changes colour to indicate a test result when in contact with a body fluid of the user. The reagent may be absorbed in a porous plastics material of the applicator or may be held in a film carrier applied as a surface layer at a contact surface of the applicator such as an outer surface of a mouthpiece. Such an arrangement also has application to dispensers other than those requiring a lockout mechanism or a detachable control unit.

Claims

CLAIMS:

1. A dispensing system (1, 2, 48) for biomedical use comprising a dispensing device (1) operable at each actuation to dispense a dose of a product; and a control device (2) connectable to the dispensing device and having a control circuit operable to control actuation of the dispensing device when the control device is connected to the dispensing device.

2. A dispensing system as claimed in claim 1 comprising a control system (48) having a docking station (40) with which the control device is connectable when separate from the dispensing device, wherein the control system is operable to configure the control device for operating the dispensing device in a predetermined manner.

3. A dispensing system as claimed in claim 2 wherein the control device comprises a memory (33) containing a database (302) and wherein the control device is operable to record a history of actuation of the dispensing device in the database for subsequent downloading to the control system.

4. A dispensing system as claimed in claim 3 wherein the dispensing device comprises an actuation request sensor (10) for sensing a user request to actuate the dispensing device; a locking mechanism (13) operable to prevent actuation; a lock actuator (14) responsive to the control device to release the locking mechanism; and wherein the control circuit comprises a processor

(30) operable to determine whether to actuate the lock actuator in response to the user request in accordance with a control program (300) and control data (301) configured by operation of the control system.

5. A dispensing system as claimed in claim 4 wherein the control system comprises a user interface (41) for entering and displaying the control data.

6. A dispensing system as claimed in any preceding claim wherein the control unit comprises a power cell (16) for energising the dispensing device.

7. A dispensing system as claimed in any preceding claim wherein the control unit comprises a reservoir (90) for containing the product to be dispensed.

8. A dispensing system as claimed in any preceding claim wherein the dispensing device comprises at least one sensor (108, 111, 112) for sensing a physiological parameter of the user and wherein the processor is operable to control actuation of the dispensing device in dependence upon a value of the sensed parameter.

9. A dispensing system as claimed in any of claims 1 to 7 wherein the dispensing device comprises at least one sensor (108) responsive in use to contact with a body fluid of the user to sense a property of said fluid.

10. A dispensing system as claimed in claim 9 wherein the sensor comprises an element (108A, 108B) formed of a porous material and impregnated with a reagent for testing said property of said fluid.

11. A dispensing system as claimed in claim 10 wherein the porous material comprises a plastics material.

12. A dispensing system as claimed in claim 11 wherein the plastics material is polyolefine.

13. A dispensing system as claimed in any of claims 10 to 12 wherein the reagent is for testing the presence of a target substance in the fluid.

14. A dispensing system as claimed in claim 13 wherein the reagent is for testing the presence of a target substance which is indicative of use of one or more of the following: alcohol, nicotine, opiates and cannabis.

15. A dispensing system as claimed in claim 13 wherein the reagent is for testing the pH level of the fluid.

16. A dispensing system as claimed in any of claims 9 to 15 wherein the sensor provides a visible indication by changing colour in response to sensing the property of the fluid.

17. A dispensing system as claimed in any of claims 9 to 15 comprising means for electrically connecting the at least one sensor to the control device for providing the control device with sensor signals and wherein the control circuit is operable to determine from the sensor signals at least one parameter value representative of a property of the fluid.

18. A dispensing system as claimed in claim 16 where the control circuit is operable to control actuation in a manner which depends upon the parameter value.

19. A dispensing system as claimed in claim 18 wherein the control circuit is operable to provide a lock-out state of the dispensing device in which further actuation is prohibited in response to a determination that the parameter value is within a prohibited range defined by a predetermined threshold against which the parameter value is compared.

20. A dispensing system as claimed in any preceding claim wherein the dispensing device comprises an applicator (7) for applying the dose of product to the user, the applicator being releasably connectable to a body portion (106) of the dispensing device to facilitate use of the dispensing device with interchangeable applicators.

21. A dispensing system as claimed in claim 20 when dependent from any of claims 9 to 19 wherein the sensor comprises at least one sensing element (108A, 108B) defining a surface of the applicator for contact in use with the user.

22. A dispensing system as claimed in claim 21 wherein the applicator is for oral presentation to the user and wherein the at least one sensing element is positioned adjacent a dispensing outlet of the application for making lip contact with the user in use.

23. A dispensing system as claimed in claim 22 wherein the sensor comprises first and second sensing elements (108A, 108B) on opposing sides of the applicator for making upper and lower lip contact in use respectively.

24. A dispensing system as claimed in any of claims 20 to 23 wherein the applicator is configured for sublingual delivery.

25. A dispensing system as claimed in any preceding claim wherein the product to be dispensed is contained in a reservoir (90, 4) constituted by a pressurised dispensing container in which the product is contained within a glass vial (4).

26. A dispensing system as claimed in any preceding claim wherein the control device and the dispensing device comprise cooperating connectors (3) operable to mechanically and electrically connect the control device to the dispensing device and retaining means (120), operable when the control device is connected to the dispensing device, to prevent subsequent disconnection.

27. A dispensing system as claimed in any preceding claim wherein the dispensing device comprises a security device (130) operable to receive an input of a security code and wherein the processor is operable to facilitate actuation of the dispensing device only if the security code is validated in accordance with security information stored in the control device.

28. A dispensing device as claimed in any preceding claim wherein the control device comprises a machine readable identifier for uniquely identifying the control device.

29. A dispensing system as claimed in any preceding claim comprising a power cell (16) for energising the dispensing device, a depletion circuit (141) operable to deplete the resources of the power cell to prevent further actuation of the dispensing device, and wherein the control circuit is operable to actuate the depletion circuit when the control device has been connected to the dispensing device and subsequently removed therefrom.

30. A dispensing system as claimed in any preceding claim wherein the control device is a disposable item.

31. A dispensing system as claimed in any preceding claim where the control device and the dispensing device are hand-holdable portable items.

32. A dispensing device for use in a dispensing system as claimed in any preceding claims and comprising actuation means (8) operable at each actuation to dispense a dose of a product; and connecting means (3) for receiving in use a control device connectable to the dispensing device wherein the dispensing device is operable in response to control signals from the control device when the control device is connected to the dispensing device.

33. A dispensing device as claimed in claim 32 comprising an actuation request sensor (10) for sensing a user request to actuate the dispensing device; a locking mechanism (13) operable to prevent actuation; and a lock actuator (14) responsive to a control signal from the control device to release the locking mechanism.

34. A dispensing device as claimed in any of claims 32 and 33 comprising a coupling (91) for coupling to a reservoir (90) of the control unit for receiving the product to be dispensed.

35. A dispensing device as claimed in any of claims 32 to 34 comprising at least one sensor (108, 111, 112) for sensing a physiological parameter of the user and means for communicating a signal representative of the parameter to the control device.

36. A dispensing device as claimed in any of claims 32 to 34 comprising at least one sensor (108) responsive in use to contact with a body fluid of the user to sense a property of said fluid.

37. A dispensing device as claimed in claim 36 wherein the sensor comprises an element (108A, 108B) formed of a porous material and impregnated with a reagent for testing said property of said fluid.

38. A dispensing device as claimed in claim 37 wherein the porous material comprises a plastics material.

39. A dispensing device as claimed in claim 38 wherein the plastics material is polyolefine.

40. A dispensing device as claimed in any of claims 37 to 39 wherein the reagent is for testing the presence of a target substance in the fluid.

41. A dispensing device as claimed in claim 13 wherein the reagent is for testing the presence of a target substance which is indicative of user of one or more of the following: alcohol, nicotine, opiates and cannabis.

42. A dispensing device as claimed in claim 40 wherein the reagent is for testing the pH level of the fluid.

43. A dispensing device as claimed in any of claims 36 to 42 wherein the sensor provides a visible indication by changing colour in response to sensing the property of the fluid.

44. A dispensing device as claimed in any of claims 36 to 42 comprising means for electrically connecting the at least one sensor to the control device for providing the control device with sensor signals and wherein the control circuit is operable to determine from the sensor signals at least one parameter value representative of a property of the fluid.

45. A dispensing device as claimed in any of claims 32 to 44 comprising an applicator (7) for applying the dose of product to the user, the applicator being releasably connectable to a body portion (106) of the dispensing device to facilitate use of the dispensing device with interchangeable applicators.

46. A dispensing device as claimed in claim 45 when dependent from any of claims 36 to 44 wherein the sensor comprises at least one sensing element (108A, 108B) defining a surface of the applicator for contact in use with the user.

47. A dispensing device as claimed in claim 46 wherein the applicator is for oral presentation to the user and wherein the at least one sensing element is positioned adjacent a dispensing outlet of the application for making lip contact with the user in use.

48. A dispensing device as claimed in claim 47 wherein the sensor comprises first and second sensing elements (108A, 108B) on opposing sides of the applicator for making upper and lower lip contact in use respectively.

49. A dispensing device as claimed in any of claims 44 to 48 wherein the applicator is configured for sublingual delivery.

50. A dispensing device as claimed in any of claims 32 to 49 comprising an applicator (7) for applying the dose of product to the user, the applicator being releasably connectable to a body portion (106) of the dispensing device to facilitate use of the dispensing device with interchangeable applicators.

51. A dispensing device as claimed in any of claims 32 to 50 wherein the product to be dispensed is contained in a reservoir (90, 4) constituted by a pressurised dispensing container in which the product is contained within a glass vial.

52. A dispensing device as claimed in any of claims 32 to 51 comprising a connector (3) operable to mechanically and electrically connect the dispensing device to the control device and retaining means (120), operable when the control device is connected to the dispensing device, to prevent subsequent disconnection.

53. A dispensing device as claimed in any of claims 32 to 52 comprising a security device (130) operable to receive an input of a security code.

54. A control device for use in a dispensing system as claimed in any of claims 1 to 31 comprising connecting means for connecting to the dispensing device; and the control device having a processor (30) operable to control actuation of the dispensing device when the control device is connected to the dispensing device.

55. A control device as claimed in claim 54 comprising means for connection to a docking station (40) with which the control device is connectable when separate from the dispensing device, wherein the control device is configurable in response to signals received from the docking station to configure the control device for operating the dispensing device in a predetermined manner.

56. A control device as claimed in claim 55 comprising a memory containing a database (302) and wherein the control device is operable to record a history of actuation of the dispensing device in the database for subsequent downloading to the control system.

57. A control device as claimed in claim 56 comprising means for receiving a signal from an actuation request sensor (10) for sensing a user request to actuate the dispensing device; means for outputting a release signal to a lock actuator (14) responsive to the control device for releasing the locking mechanism; and wherein the processor is operable to determine whether to output the release signal in response to the signal from the actuation request sensor in accordance with a control program and control data configured by operation of the control system.

58. A control device as claimed in any of claims 54 to 57 comprising a power cell (16) for energising the dispensing device.

59. A control device as claimed in any of claims 54 to

58 comprising a reservoir (90) for containing the product to be dispensed.

60. A control device as claimed in any of claims 54 to

59 comprising means for receiving signals from at least one sensor (108, 111, 112) for sensing a physiological parameter of the user and wherein the processor is operable to output control signals to control actuation of the dispensing device in dependence upon a value of the sensed parameter.

61. A control device as claimed in any of claims 32 to

60 comprising a connector (3) operable to mechanically and electrically connect the control device to the dispensing device and retaining means (120), operable when the control device is connected to the dispensing device, to prevent subsequent disconnection.

62. A control device as claimed in any of claims 32 to

61 operable to receive an input of a security code and wherein the processor is operable to output control signals to facilitate actuation of the dispensing device only if the security code is validated in accordance with security information stored in the control device.

63. A control device as claimed in any of claims 32 to

62 comprising a power cell (16) for energising the dispensing device, a depletion circuit (141) operable to deplete the resources of the power cell to prevent further actuation of the dispensing device, and wherein the processor is operable to actuate the depletion circuit when the control device has been connected to the dispensing device and subsequently removed therefrom.

64. A control device as claimed in claim 60 wherein the control circuit is operable to provide a lock-out state of the dispensing device in which further actuation is prohibited in response to a determination that the parameter value is within a prohibited range defined by a predetermined threshold against which the parameter value is compared.

65. A method of operating a dispensing system for biomedical use comprising a dispensing device (1) operable at each actuation to dispense a dose of a product; the method comprising: connecting a control device (2) to the dispensing device and operating a processor (30) of the control device to control actuation of the dispensing device when the control device is connected to the dispensing device.

66. A method as claimed in claim 65 comprising connecting the control device to a control system having a docking station (40) with which the control device is connectable when separate from the dispensing device, and operating the control system to configure the control device for operating the dispensing device in a predetermined manner.

67. A method as claimed in claim 66 wherein the control device comprises a memory (33) containing a database (302) and wherein the method comprises operating the control device to record a history of actuation of the dispensing device in the database and subsequently downloading the history to the control system.

68. A method as claimed in claim 67 wherein the dispensing device comprises an actuation request sensor for sensing a user request to actuate the dispensing device; a locking mechanism (13) operable to prevent actuation; a lock actuator (14) responsive to the control device to release the locking mechanism; and wherein the method comprises operating the processor to determine whether to actuate the lock actuator in response to the user request in accordance with a control program and control data configured by operation of the control system.

69. A method as claimed in claim 68 wherein the control system comprises a user interface and the method comprises operating the user interface (41) to enter and display the control data.

70. A method as claimed in any of claims 65 to 69 wherein the dispensing device comprises at least one sensor (108, 111, 112) for sensing a physiological parameter of the user and wherein the method comprises operating the processor to control actuation of the dispensing device in dependence upon a value of the sensed parameter.

71. A method as claimed in any of claims 65 to 70 wherein the dispensing device comprises a security device (130) which receives an input of a security code and wherein the processor facilitates actuation of the dispensing device only if the security code is validated in accordance with security information stored in the control device.

72. A method as claimed in any of claims 65 to 71 comprising energising the dispensing device from a power cell (16), and wherein the processor actuates a depletion circuit (141) when the control device has been connected to the dispensing device and subsequently removed therefrom to deplete the resources of the power cell to prevent further actuation of the dispensing device.

73. A storage medium (45) storing processor implementable instructions for controlling a processor to carry out a method as claimed in any one of claims 65 to 72.

74. An electrical signal (46) carrying processor implementable instructions for controlling a processor to carry out a method as claimed in any one of claims 65 to 72.

75. Dispensing apparatus comprising dispensing means (4) for dispensing a metered dose of a product as an airborne aerosol or powder, and an applicator (7) for guiding delivery of the dispensed dose, wherein the applicator comprises at least one sensor (108A, 108B) responsive in use to contact with a body fluid of the user.

76. Dispensing apparatus as claimed in claim 75 wherein the sensor comprises a porous material impregnated with a reagent for testing said property of said fluid.

77. A dispensing system substantially as hereinbefore described with reference to and as shown in any of the accompanying drawings.

78. A dispensing device substantially as hereinbefore described with reference to and as shown in any of the accompanying drawings .

79. A control device substantially as hereinbefore described with reference to and as shown in any of the accompanying drawings .