WO2010052470A1

WO2010052470A1 - Medicament system

Info

Publication number: WO2010052470A1
Application number: PCT/GB2009/002622
Authority: WO
Inventors: Daniel John Wynne Ellis; Mark Robert Pennington; Robert Anthony Marchant; James Frederick Bower; Pamela Stewart Cain; Richard John Bishop
Original assignee: Mediche Limited
Priority date: 2008-11-06
Filing date: 2009-11-06
Publication date: 2010-05-14
Also published as: EP2350896A1; WO2010052470A8

Abstract

A medicament monitoring system comprising a medicament delivery device, a server and a database; wherein the medicament delivery device interacts with a communication device operable in use to transmit medicament data to the server; the server being operable to receive the medicament data from the medicament delivery device, and associate that medicament data with information identifying a user of the medicament delivery device, the server being further operable to store that associated medicament data as a record in the database.

Description

Medicament System

This invention relates to a medicament system, including a medicament delivery device and/or monitoring device and related devices. The invention relates particularly, but not exclusively to an injector, such as a medical pen-type injector.

Pen-type injectors are well-known for self-injection of medicaments such as insulin. In use the user loads the pen with a supply of medicament, and positions it for injection through the skin. Typically the user will select a pre-determined dose, for example by rotation of a setting wheel of the pen, and initiate an injection operation by pressing a button or the like. A replaceable cartridge of medicament is usually provided, and may comprise a plurality of individual doses.

Such injectors are a convenient and rapid method of administering a medicament. However the user is required to determine the time and amount of injection, and preferably to record these parameters for future reference, for example by a medically qualified adviser.

For some medical conditions, a user may self-administer a fixed dose at predetermined times, according to a fixed schedule. For other conditions, such as diabetes, the dosage will vary according to measurable parameters, such as the blood sugar level, and not necessarily be suitable for administration at convenient times.

Accordingly there is a requirement to provide a reliable apparatus and method of indicating to a user the time of administration of medicament, and the dosage thereof. Furthermore it would be desirable for data concerning the administration to be recorded for analysis. According to a first aspect of the invention we provide a portable medicament delivery device for personal use operable in use to deliver a dose of a medicament to a user, the medicament delivery device comprising a memory operable in use to record medicament data associated with the dose of medicament.

The portable medicament delivery device may further comprise an electronic display for displaying medicament data.

The medicament data may comprise at least one of: a time and date at which the dose of medicament was delivered; a time and date at which a dose of medicament is to be delivered (e.g. suggested dose information); and a dosage value of a dose of medicament.

The memory may be operable to record medicament data for a plurality of doses of medicament. Thus a history of stored medicament data may be built up automatically as the user uses the device.

The portable medicament delivery device may further include a communication device operable in use to transmit medicament data to a related device, for example a housing arranged to store the device, a personal computer, or a remote server in communication with a database.

The portable medicament delivery device may further comprise an alarm, the alarm being operable to indicate to the user that a dose of medicament is due. The alarm may be programmable by the user, and/or may be arranged to operate in response to a signal from a related device.

The portable medicament delivery device may be associated with a home time zone of the user, the device being operable to convert the medicament data into a local time associated with a remote time zone, and to display medicament data in that local time. A user may indicate to the device that he or she is in a remote time zone. The portable medicament delivery device may comprise a pen-type injector having a casing for holding a medicament, a mount for an injection needle, and an actuator for in use injecting the dose of medicament through the injection needle.

The medicament may be held in a cartridge or vial, and the device may be operable to detect a type of that cartridge.

The casing may comprise two portions, a cartridge portion and a generic portion. The generic portion may be operable to determine which specific cartridge portion selected from a plurality of cartridge portions is connected to it, e.g. using an arrangement of contacts provided on the specific cartridge portion.

According to a second aspect of the invention we provide a medicament monitoring system comprising a medicament delivery device in accordance with the first aspect of the invention, a server and a database; wherein the medicament delivery device is operable to interact with, and may comprise, a communication device operable in use to transmit medicament data to the server; the server being operable to receive the medicament data from the medicament delivery device, and associate that medicament data with information identifying a user of the medicament delivery device, the server being further operable to store that associated medicament data as a record in the database.

The database may comprise a plurality of records of associated medicament data for the user.

The user may be permitted to view the associated medicament data using a related device having a display device. The related device may be a medicament device housing, a computer, the medicament delivery device itself, or a similar medicament delivery office, or any other device operable in use to retrieve information from the server, such as a mobile phone.

A related device may comprise a medicament monitoring device. The related device may be operable to transmit analysis data obtained from a measurement made on the user using the medicament monitoring device to the server, the server being operable to associate that analysis data with the user, and store that associated analysis information as a record in the database. A plurality of such records may be stored.

The user may be permitted to input related data to the server using a related device, and the server may be operable to store that related data as a record in the database. A plurality of such records may be stored. The related data may comprise an exercise value for the user, a food value for the user, and/or an analysis value for the user, e.g. a blood pressure of the user, a weight of the user, a blood sugar level of the user.

The server may be operable to cause the display device to display a user medicament history, the history comprising a plurality of records of associated medicament data and/or associated analysis data and/or related data. The user medicament history may be displayed as a graph showing a variation in at least one of associated medicament data and associated analysis data over time. The graph may show the variation in both medicament data and analysis data, so that they might be compared

The server may be further operable to transmit a reminder to the user. A time and date of the reminder may be preselected by the user. Alternatively, or additionally, a time and date of the reminder may be determined automatically by an algorithm. The algorithm may be operable to determine the time and date of the reminder using at least one of medicament data, analysis data and related data. For example the algorithm may analyse the user medicament history, and predict when one or more future medicament does might be required. The server may be operable to transmit the reminder to the medicament delivery device. Additionally, or alternatively, the server may be operable to transmit a reminder to a related device, such a mobile phone.

The server may be further operable to transmit a reminder or an alert to a designated person, such as a medical practitioner or a family member designated by the user.

According to a third aspect of the invention we provide a related device in the form of a housing for storing a portable medicament delivery device in accordance with the first aspect of the invention, said housing comprising a communication device operable in use to receive medicament data from the injection device, and a housing memory operable in use to record the medicament data.

The housing may further comprise a display device. The display device may be arranged to be viewable from the interior of the housing, or from the exterior of the housing, at the selection of a user, i.e. the display device may be reversible.

The housing may be book-like, and said display device may be in one cover thereof.

The housing may comprise a user input means, by which a user can input data to be stored in the housing memory, e.g. related data, as discussed above.

The housing may comprise an analysis tool to determine analysis data comprising a physiological measure of a user. The analysis tool may be a glucose meter, and the physiological measure may be a blood sugar concentration. The analysis tool may be integrated with the housing. Where the housing is book-like, the analysis tool may be in the same 'leaf as the display device.

The analysis data may be stored in the housing memory.

The or a further communication device may be operable to transmit medicament data and/or analysis data and/or related data to a server, as discussed in relation to the second aspect of the invention.

The housing may further comprise at least one compartment for storing at least one of: an injection needle; and, a medicament.

The housing may comprise the medicament delivery device of the first aspect of the invention.

According to another aspect of the invention, there is provided a pen- type injector comprising a casing for incorporating a medicament, a mount for an injection needle and an actuator for injecting a dose of medicament in use, the injector further including an electronic display on the casing thereof.

Such a display may for example indicate a date and time of a next injection, and/or a date and time of a previous, e.g. a most recent, injection.

The injector may further include a programmable device to permit a user to pre-select the time and date of next injection, and most preferably a memory to allow the time and date of successive injections to be pre-selected.

Preferably the memory device is adapted to hold sufficient data for 12 months usage.

In the case of an injector with adjustable dose setting, the display may indicate the dosage to be administered, and preferably a programmable memory is provided to permit successive dosages to be pre-selected. The injector may incorporate a data input device to permit manual programming of the programmable device, or may incorporate a connector to permit downloading or uploading of data from or to another device. Such a connector may comprise external contacts, a USB connector, or other suitable physical connection. The connector may alternatively be contactless, and rely for example upon infra-red, radio or other electromagnetic signals.

The injector includes a memory to record data concerning each successive injection, for example the date, time and amount of medicament which has been injected. Such data is may be different from display data indicating the date, time and amount of the next and/or previous injection, and may be recorded in real time. The display data may also be recorded for comparison and analysis purposes.

In one embodiment data recorded at the time of injection may not be displayed, but is stored for subsequent analysis. The injection data may thus be hidden from the user and may provide a medically qualified adviser with essential information concerning compliance with a prescribed regime.

The injector may further incorporate an alarm to indicate to the user that a next injection is due. Such an alarm may be in any convenient form, and for example be visible and/or audible, and preferably comprises an electronic reminder circuit.

The programmable device may include a register to accumulate time and dose information, and pre-determined reference data. The programmable device preferably periodically compares information in the register with reference data to determine deviation from a norm associated with the user. Thus for patient having diabetes, the register may record time and dose so as to allow variation in blood sugar levels to be tracked, and to trigger an alarm in case of excessive deviation or the likelihood of such deviation. A contactless communication device may be incorporated in the injector for transmission of data. A mobile phone device may be utilised, and may be polled on demand, or may transmit data according to a predetermined schedule. This feature permits external monitoring of a patient, and may be associated with an alarm in case of non-compliance or deviation.

The display may be of the LCD or TFT type and may compris a generally oblong screen with the long axis aligned with the rotational axis of the injector. The display may be touch sensitive to permit data input directly by the user, typically in the form of alpha-numeric characters.

The needle mount may be adapted to receive a replaceable needle, and the injector may incorporate a mechanism to retract the needle and/or mount from an active condition to a storage condition. The medicament may be provided as a replacement cartridge, vial or the like.

The injector may incorporate a communication device associated with a cartridge and/or needle to permit configuration of the injector in a manner appropriate to the relevant attachment. Thus the injector may be configured for a range of needle gauge sizes and/or a range of different medicaments. The means of configuration may be physical, but preferable wireless communication is provided whereby a programmable device of the injector interrogates the attachment electronically and if necessary adjusts an electronic dosage control to display the allowable dose to the user. In a further modification the injector may incorporate a dose adjuster adapted to respond to an electronic dosage control so as to limit the injector dose to a permissible amount, or to a range of permissible amounts.

The injector may include a language, time zone and units, module to permit selection of the user's preferred language and/or time settings on demand. In accordance with another embodiment, the injector of the invention is provided in combination with protective housing from which it is removable on demand. Such housing may be in the form of a book in which the injector lies immediately adjacent the hinge, or in a convenient position to facilitate removal. The housing preferably includes a closure such as a press-stud, zip or hook and loop fastener.

The housing may further include one or more needles for the injector and one or more cartridges of medicament. Used needles and cartridges may replace unused replacements as they are attached to the injector.

The housing may incorporate a separate electronic display from the injector. Such a display can typically display more information than the display of the injector, and in magnified form. Such a separate display may substantially fill one leaf of a book-like housing, and be reversible so as to display to the inside, or through a window to the outside. Preferably the other leaf of such a book-like housing incorporates additional needles and cartridges of medicament. The separate display may comprise a touch screen for data entry.

The housing may communicate with the injector wirelessly by for example Bluetooth, WiFi or GPRS, 3G or any other short or long range wireless communication technology, but suitable hard connections may be provided by USB, RS232 plain contact connectors, or another suitable connector. The housing may further communicate with external devices wirelessly or via a physical connection, and may incorporate a communication device.

In a preferred embodiment, the housing further includes an analysis device which, in the case of a book-like housing is provided on one inside leaf thereof, e.g. same leaf as the display, or the opposite leaf to the display. The analysis device is adapted to determine a physiological parameter, such as blood sugar level, of a user. Typically a small blood sample is taken by finger pressure on a lancet or pricker, and electronic analysis circuitry determines the relevant value.

Preferably the analysis device communicates with the injector and/or the separate display and/or the communication device (e.g. for transmission to a server) so as to indicate the results of the analysis and to provide data to a calculator to permit an injector dosage to be determined. The calculator may be provided in the injector, and may be preferably associated with the programmable device in the form of a microprocessor. The results of the analysis device may be translated directly into a dosage of an appropriate medicament, preferably by reference to a pre-set algorithm. The analysis results may further be compared with prior dosage information held in a register of the injector so as to determine a predicted dosage regime whereby the dosage history of a user can be used to determine the amount and timing of a succession of future doses.

In this form the invention can thus provide in a single housing an analysis device, an injector and the associated attachments, and a large format display whereby reliable medication can be promoted. The feature of external communication allows remote monitoring and messaging. The apparatus of the invention is of undeniable benefit to a busy user whose attention may be distracted by other events, to the detriment of a required medication regime.

It will be appreciated that features discussed in relation to one aspect of the invention may be employed in other aspects of the invention.

Other features of the invention will be apparent from the following description of a preferred embodiment illustrated by way of example only in the accompanying drawings, in which:-

Figure 1 is an illustrative side elevation of an injector pen; Figure 2 is an open book-like housing for an injector pen and associated devices;

Figure 3 is a perspective view of an alternative injector pen; Figure 4 is a perspective view of an alternative housing for an injector pen;

Figure 5 is a network diagram;

Figure 6 is a screen shot of a monitoring website; and

Figure 7 is a screen shot similar to that of Figure 6.

Referring firstly to Figure 5, a medicament management system 200 is described. The system comprises one or more portable medicament monitoring or delivery devices 210, 212 for personal use.

The medicament delivery device 210 and/or the medicament monitoring device 212 comprise a memory, in which medicament data regarding medicaments delivered to the user by the user and/or measurements made on the user by the user are automatically stored. The device 210, 212 might be any device suitable for use by an individual to make measurements on himself, or to deliver medication to himself. In the examples described herein the device is an insulin injection device, but it will be appreciated that other devices could be used instead, or as well.

The or each device 210, 212 is in communication (wired or otherwise) with a website and database 230 hosted on a secure server 235 via the internet, VPN or private secured tunnelled connection or private network 240.

The measurement data is uploaded in use into the database where it is associated with information identifying the user and stored in a record which and can be viewed by the user and, possibly, amended or added to, by the user, accessing the website. The devices 210, 212 may communicate directly with the secure server, or communication may be via an intermediate device, such as a mobile communication device, such as a housing 220, or a personal computer 250. The mobile housing 220 may include a further measuring device and a housing memory, and may also include a display device on which recorded data and, perhaps, the website might be displayed. Analysis information from

5 the further measuring device might also be uploaded, associated with the user and stored in the database.

The user may input other related information to the system, e.g. regarding food he or she has eaten, exercise taken, or measurements made I O using another device. The user may input the related information using a mobile device 210, 212, the housing 220, or any other device operable in use to access the website (e.g. computer 250, or a mobile phone). That information may also be associated with the user and stored in the database.

15 Using the above system a user is able to build up a history of dose and/or measurement information which can be viewed at any time via the website. The information is recorded automatically, and so the history is built up passively, without the need for input from the user, and can be viewed remotely. 0

Another person, such as a family member or a medical practitioner might also view information stored in the database using the website via, for example, a medical practitioner's computer 260. In that case, a user's medical practitioner may be able to use the history information to monitor the 5 user's condition, and provide treatment advice.

For example, a user having diabetes must regularly inject himself with insulin. The amount of insulin to be injected depends on the blood-sugar level of the user, which the user himself often measures. That blood-sugar level 0 depends to some extent on external factors, such as what the user has eaten, and whether the user has exercised. A person with a condition such as diabetes cannot therefore simply adhere to a regular schedule of doses of insulin, as the dose to be administered, and the time of administration may vary from day to day.

It is therefore necessary for a user with diabetes to remember the time

5 of his or her last insulin dose in order to anticipate when the next dose will be required. However, in view of the variety of factors mentioned above which might affect that time, it can be difficult for a user to predict exactly when they will require their next dose. It is common therefore for diabetics to over or under dose with insulin. Under dosing can cause long term health problems,

I O such as blindness and poor circulation, sometimes leading to the need for amputation. Over dosing means that unnecessary insulin is used, which is expensive, and can also result in health problems.

With the system described herein, a user is able to see information

15 about the time and amount of insulin taken for a plurality of previous doses, which may help him or her to more accurately determine their next dose. A medical practitioner is also able to access the individual's dose history, and review how well the individual is managing their condition. Many instances of dose information can be stored, so that a dose history spanning months, 0 years, or even decades can be automatically built up for the user.

The system may also be operable to predict when the user's next dose might be due, and to indicate to the user a suggested time and/or amount of that dose. Alternatively, or additionally, the system may be operable to issue 5 the user with reminders. Furthermore, the system may be operable to issue the medical practitioner and/or others with alerts or updates on the user, perhaps in response to parameters set by the practitioner, the user and/or others. 0 With reference to Figure 1 , a medicament delivery device in the form of a pen-like injector 10 is shown. The injector 10 comprises a casing, in this example a two-part barrel 11 , 12 having a pen clip 13. The barrel incorporates a removable cartridge of medicament, a mount comprising a retractable needle and an actuator for dispensing medicament via the needle; these features are conventional, and not illustrated.

The injector also includes an electronic display, for example an LCD, LED, OLED, TFT₁ or any other suitable display 14.

The display 14 is adapted to indicate to a user information associated with the injection, for example a date and time of next injection and/or a dosage of medicament. The pen may include a conventional setting device (not shown) to permit user variation of the dosage, for example as indicated on the display 14.

The pen may include one or more of an alarm to indicate to the user that a dosage is due; a programmable device to allow programming of the date and time of next injection(s), and the programming of a successive dosage regime; a data input device, such as a touch screen; a connector, which may be wireless, to permit communication with other devices for data upload and download; a memory to record successive injection data; a register to allow accumulated data to be summed; and a processor responsive to register data and memory data to determine a dosage regime.

Indications of these additional functions are provided on the display 14, which may cycle automatically if desired. The provision of a display on the injector allows immediate reference information for the user, who may for example have forgotten the time or amount of the previous dosage, or the time and amount of the next dosage.

Furthermore, the injector is adapted to record and display actual dosage and time of injection without need of a separate record made for example in writing. Such data is an invaluable reference for a medically qualified advisor, especially in cases of poor patient compliance, or absence or loss of a written record. Figure 2 illustrates a housing comprising a book-like enclosure 20 for housing an injector pen 10 adjacent the spine 21 thereof. One inside cover 23 of the enclosure is adapted to contain a large format display screen (not shown) which can repeat or enlarge data from the display 14. An opening or transparent window 22 allows the large format display to be reversed, so as to be viewable either from the outside or from the inside. A wallet-sized enclosure may thus be kept closed until needed since the essential data can be viewed through the opening or window 22.

The other inside cover 24 includes a plurality of compartments, which by way of example comprise three long compartments 25 for cartridges of medicament; four square compartments 26 for replaceable needles, and one large compartment 27 for an analysis tool. The shapes of these compartments can be adapted to the shape of the apparatus to be contained therein.

For reasons of clarity, the contents of each compartment are not illustrated. Cartridges and needles are of conventional form dictated by the design of the pen-like injector. The analysis tool typically comprises a conventional finger pricker, and a blood analyser.

A microprocessor device incorporated in the pen injector 14 communicates with the analysis tool and the large format display so as to permit upload and download of data. The results of an analysis are for example transmitted to the microprocessor device so as to permit calculation of the next dosage, or next series of dosages to be injected. The large format display may also include a memory and processor associated with injection data. Such a memory may have a capacity for data storage of up to 10 years.

It is envisaged that the pen injector, analysis tool and large format display will carry on-board power, such as replaceable dry button cells. It will however be understood that a single power storage device may communicate with each component by means of electrical connectors or touch contacts. Data communication between the components may be wireless or via hard connectors, of any suitable form.

5 In Figure 3 a medicament delivery device in the form of an alternative injector pen 1 10 is shown. Like the injector 10 of Figure 1 , the injector 110 includes a casing having a first portion 111 , which is this example is adapted to receive a cartridge or vial of a medicament such as insulin (not shown), and a second portion 112, which in this example houses a display 114. I O

The injector pen further includes an injector memory, an injector controller, and a clock circuit (not shown, as these components are internal to the injector).

15 In use, the dosage of medicament to be delivered can be determined by a user using a dial 116. That dose will then be delivered to the user via a needle (not shown) when a button 117 is pressed.

Typically, an injector pen delivers a medicament dose by drawing 0 medicament from a vial or cartridge loaded into the device until the dose set by the dial 116 has been delivered through the needle.

There are numerous different types of medicament vial or cartridge which might be used in the injector 110, depending on the type of medicament 5 to be delivered, as well as on the manufacturer of the vial. Some vials may have different diameters, or different concentrations of a medicament. The injector 110 is arranged to detect which vial has been loaded into the first portion 111 , to ensure that the dose set by the user is the same as the dose which is delivered when the button 117 is pressed. 0

For example, a plurality of different cartridge portions 111 might be provided, each suitable for use with a particular vial, or a particular diameter or concentration of vial. Contacts 119 might be provided on each cartridge portion 111 , such that the location and/or number of the contacts 119 is unique to a respective vial. The injector is arranged to determine from the distribution of the contacts which cartridge portion 111 is attached, and so which vial is used. The controller is thus able to determine how far to advance the vial in order to deliver the selected dose.

When a dose is delivered, the controller is arranged to reference the clock to determine the date and time, and to store that date and time, along with the dose delivered, in the memory. Over time, a store of dose information is built up in the memory, providing a history of the doses of medicament delivered to the user of the injector pen.

As discussed above, information regarding for example, a suggested date and time of one or more future doses, and/or a suggested amount of one or more future doses, might be stored in the injector memory (by the user or otherwise, for example, estimated by an algorithm, as discussed later). The injector controller may be arranged to display that suggested dose information to the user of the injector. The user may use that suggested dose information when deciding when to administer his or her next dose. Alternatively, the user may ignore that information and deliver his or her next dose when he or she wishes.

The controller may store the suggested dose information, as well as the actual delivered dose information, in the injector memory, so that they might be compared.

The injector pen includes an alarm (not shown), for example an audible alarm, a vibrator, or a visible alarm such as a flashing light (in one or more colours), to remind the user that a suggested time of dose is approaching and/or to remind the user that the suggested time of dose has arrived or has passed. For example, the alarm might sound one or two minutes before the dose is due, or ten minutes, or even an hour in advance, perhaps as selected by the user, or as determined by the controller. The injector pen comprises a communication device to allow it to communicate information stored in the injector memory to a housing, discussed in more detail below, and/or to the user's personal computer, 5 and/or to the remote server via the internet.

Figure 4 shows a housing 120 similar to that shown in Figure 2, comprising securing means, such as a pocket, for housing an injector pen 10, 110 when the injector is not in use. The housing also includes I O various compartments 125, 126 for holding associated items, for example vials of medicament 128, such as insulin, replacement needles 130, and replacement sensor components 132 (e.g. test strips and lancets for use with a glucose meter).

15 The housing further includes a housing display 134, a housing memory

133 and a housing controller 135. The housing display, housing memory and housing controller may be provided in a removable device, such as a mobile phone, PDA or other electronic computing device. In that case, the display may be turned around by the user, as in the embodiment discussed with 0 respect to Figure 2. Alternatively, the housing display, memory and controller may be formed as an integral part of the housing.

The housing also includes an analysis tool 136, such as a glucose meter. The glucose meter may operate in a conventional way, for example by 5 detecting the colour of a test strip onto which a drop of the user's blood has been placed. Where the display comprises a mobile phone having a camera, that camera may be used as part of the glucose meter.

Some medicaments, such as insulin, are sensitive to temperature, and 0 so the housing and/or the injector pen may include a temperature sensor. The housing and/or the injector may also include a device capable of controlling the temperature. The output of the glucose meter and/or the temperature sensor may be displayed on the display and/or may be stored in the housing memory, along with a time and date at which the measurement was recorded. In the event that the recorded temperature exceeds/falls below a predetermined limit, a warning might be provided to the user.

The housing controller is operable to communicate with the injector controller. In the embodiment shown, the injector communicates with the housing wirelessly, for example, via Bluetooth. When the injector has information to upload, the injector might regularly emit a signal, for example once every minute, which can be detected by the housing. When the housing receives such a signal emitted by the pen, it replies to the pen, establishing a communication link, and a data transfer may be automatically initiated. The data transfer may be operable to upload information from the injector memory to the housing memory, and/or to synchronise data stored in the injector memory with data stored in the housing memory.

The housing is provided with a user input device, in this example in the form of a touch screen. Using the user input device a user is able to input information to the memory. For example, the user may view and input information about medicament doses that have been delivered (perhaps using a different injector) and glucose measurements that have been made. The user may also input information about food they have eaten, exercise they have taken, and/or any other medical or non-medical information.

Referring now to Figures 6 and 7, a website 300 in accordance with the invention is shown. The website can be accessed from any computer, as is conventional, for example a user's personal computer 250. The housing and/or the medicament delivery device may also be arranged so that the website can be accessed from one or both of those devices.

In Figure 6 a user of the system, shown here as Mark Pennington, is logged in to the Mediche website 300 hosted on the server 235, and that user's profile page is displayed. The profile page displays data stored on the database 230 in two main ways.

The graph 304 displays any information stored within the database that the user has elected to display. For example the graph may show a change in glucose levels over time, and/or a change in medicament data -overtime. The user might be able to see from the graph how his glucose levels have varied with e.g. exercise taken, food eaten, alcohol consumed and medication (e.g. insulin) taken.

A table 308 displays a list of statistics which may include glucose readings, carbohydrate readings, medication readings, and activity readings measured in any preferred units or industry standard.

The user can input information to the database, for example by selecting the 'add event' button 310, as shown in Figure 7, or can add multiple pieces of information to the database, for example by selecting the 'add multiple events' button 312. The table and graph is automatically updated to include the new values added by the user.

The user is thus able to see how their glucose levels have varied over time, and how their food, activity and medication intake has affected their glucose levels. Thus the user is provided with a global view of their medication history, which he or she can take into account when deciding what to eat, how much to exercise, how much medication to take, and when.

The user is also able to socialise with other individuals having the same or similar medical conditions using the website 300. The website provides the user with the ability to view other individuals' profiles using the 'your friends' tab 314, and to chat with other individuals using the 'forum' tab 316. The user can also view and search information about their condition in an information database using the 'wiki' tab 318. The database might also include information regarding pharmacies and clinics, and details of their location, which might be useful if, for example, the user travels to a place with which he or she is not familiar. The user's location could be ascertained either by manual input or automatically through location based technologies such as GPS or GSM/3G cell location.

A settings tab 320 navigates a user to a settings page, using which the user can alter their account settings. For example, the user can invite another user to be their 'friend' and so allow that user to view their profile.

Using the website the user can configure the system to provide one or more automated reminders. For example, as mentioned above, the user may want reminders to be sent to him or her in advance of a suggested dose time programmed by the user. Alternatively, or additionally, the user might want reminders or alarms sent to him or her at the suggested dose time.

Alternatively, the user might want the system to send ad hoc reminders. In that case, an algorithm might be provided to determine from the data entered by the user that a medicament dose might be needed. For example, the algorithm might determine that the user's glucose level has risen/fallen sharply, or often does so at a particular time of day, indicating that a medication or sugar dose might be required. Upper and lower limits 322, 324 might be provided, such that the user's recorded data falling above or below those limits indicates the user may be in danger of entering a hyper/hypoglycaemic state. The system may be arranged to determine that fact, or that the user's data has a history doing that at a given time, and warn the user accordingly.

The user can ask for reminders to be sent to one or all of the medicament delivery/monitoring device, the device housing, and his home computer (e.g. by email). The user might also ask for alerts to be sent to his or her mobile phone, for example by SMS text message, or by email, or by automated telephone message. The user can manage these setting using the website, and can also specify that he or she wants the system to send no reminders at all. The user might also give his or her medical practitioner permission to alter the system settings, or to set up their own reminders to be sent either to the medical practitioner or to the user.

In one embodiment the housing is arranged to communicate with the user's personal computer, and the medicament delivery device is arranged to communicate with the housing. Thus, any changes the user makes on the website, e.g. entering new activity information, or changing reminder settings, are propagated to the other devices when the user connects the housing to his (or any other) computer and accesses the website. Similarly, any new information recorded by the delivery device and recorded by or entered into the housing is uploaded to the database when the housing is connected to a computer accessing the website.

Alternatively, or additionally, data could be uploaded from and downloaded to the housing and/or the delivery device directly to/from the website at regular intervals wirelessly, for example using GPRS, 3G or any other short or long range wireless communication technology network.

Thus no matter where the user is, he can access and update his history information.

It will be appreciated that it is important that the time and date of the stored information is accurate if the history information is to be useful. Thus it is important that each device (delivery device, housing, computer and website) all use the same time. Thus, when two or more devices are connected, clock information from those two respective devices is compared and synchronised.

In the event that a user travels, he might enter a different time zone to the one he normally inhabits. Doing that might cause the user to become confused about when his next dose needs to be administered. In order that the user does not become confused, the delivery device, housing and website are operable to display dose information, including the suggested dose information, in the local time. In order to do that it may be necessary for the user to input on the website that he is travelling, and the time zone to which he is travelling, so that the time displayed on the injector can be adjusted. Alternatively, or additionally, the delivery device and/or housing may determine from the GPRS, 3G or any other short or long range wireless communication technology network that it is roaming beyond its home region, and prompt the user to update the time zone.

Even when the time zone has been updated, all data is stored in the same time zone (e.g. UTC) to avoid confusion when viewing the history information in the future.

Various modifications may be made without departing from the scope of the invention.

Although a book-like enclosure has been described, with pockets to retain components therein, other shapes of enclosure and methods of retention are envisaged provided only that easy removal of the injector pen is facilitated. The injector may be housed in a different location than adjacent the 'spine' of the housing. Furthermore it will be appreciated that other components associated with a medical condition may be incorporated with the pen injector, as required.

It will be appreciated that whilst the above invention has been mainly described with respect to wireless communication, an injector pen may communicate with the housing using a wired connection. For example, a male USB connector might be provided on the pen, and a corresponding female USB connector might be provided on the housing. In such an embodiment, data may be automatically transferred from the pen to the housing when the connector of the pen is plugged in to the connector of the housing. It will be appreciated that multiple medicament delivery devices or personal measuring devices may be associated with a single user.

Whilst endeavouring in the foregoing specification to draw attention to those features of the invention believed to be of particular importance it should be understood that the applicant claims protection in respect of any patentable feature or combination of features hereinbefore referred to and/or shown in the drawings whether or not particular emphasis has been placed thereon.

Claims

1. A portable medicament delivery device for personal use operable in use to deliver a dose of a medicament to a user, the medicament delivery device

5 comprising a memory operable in use to record medicament data associated with the dose of medicament.

2. A portable medicament delivery device according to claim 1 , further comprising an electronic display for displaying medicament data.

I O

3. A portable medicament delivery device according to claim 1 or claim 2, wherein the medicament data comprises at least one of: a time and date at which the dose of medicament was delivered; a time and date at which a dose of medicament is to be delivered; and a dosage value of a dose of

15 medicament.

4. A portable medicament delivery device according to any preceding claim, wherein the memory is operable to record medicament data for a plurality of doses of medicament. 0

5. A portable medicament delivery device according to any preceding claim, further including a communication device operable in use to transmit medicament data to a related device. 5 7. A portable medicament delivery device according to any preceding claim, wherein the device further comprises an alarm, the alarm being operable to indicate to the user that a dose of medicament is due.

8. A portable medicament delivery device according to claim 2 or any claim 0 dependent thereon, wherein the device is associated with a home time zone of the user, and wherein the device is operable to convert the medicament data into a local time associated with a remote time zone, and to display medicament data in that local time.

9. A portable medicament delivery device according to any preceding claim, 5 wherein the device comprises a pen-type injector having a casing for holding a medicament, a mount for an injection needle, and an actuator, for in use injecting the dose of medicament through the injection needle.

10. A portable medicament delivery device according to claim 9, wherein the I O medicament is held in a cartridge, and the device is operable to detect a type of that cartridge.

11. A medicament monitoring system comprising a medicament delivery device in accordance with any preceding claim, a server and a database;

I 5 wherein the medicament delivery device interacts with a communication device operable in use to transmit medicament data to the server; the server being operable to receive the medicament data from the medicament delivery device, and associate that medicament data with information identifying a user of the medicament delivery device, the server being further operable to 0 store that associated medicament data as a record in the database.

12. A system according to claim 11 , wherein the database comprises a plurality of records of associated medicament data for the user. 5 13. A system according to claim 11 or claim 12 wherein the user can view the associated medicament data using a related device having a display device.

14. A system according to claim 13 wherein the related device is one or 0 more of: a medicament device housing; a computer; and the medicament delivery device.

15. A system according to claim 13 or claim 14 wherein the related device comprises a medicament monitoring device, and wherein the related device is operable to transmit analysis data to the server, the server being operable to associate that analysis data with the user, and store that associated analysis

5 information as a record in the database.

16. A system according to any one of claims 13 to 15 wherein the user can input related data to the server using the related device, and the server is operable to store that related data as a record in the database.

I O

17. A system according to any one of claims 13 to 16 wherein the server is operable to cause the display device to display a user medicament history, the history comprising a plurality of records of associated medicament data and/or associated analysis data and/or related data.

15

18. A system according to claim 17 wherein the user medicament history is displayed as a graph showing a variation in at least one of associated medicament data and associated analysis data over time. 0 19. A system according to any one of claims 11 to 18 wherein the server is further operable to transmit a reminder to the user.

20. A system according to claim 19 wherein a time and date of the reminder is preselected by the user. 5

21. A system according to claim 19 wherein a time and date of the reminder is determined automatically by an algorithm.

22. A system according to claim 21 wherein the algorithm is operable to 0 determine the time and date of the reminder using at least one of medicament data, analysis data and related data.

23. A system according to any one of claims 19 to 22, wherein the server is operable to transmit the reminder to the medicament delivery device, or to another device accessible by the user.

5 24. A housing for storing a portable medicament delivery device in accordance with any one of claims 1 to 10, said housing comprising a communication device operable in use to receive medicament data from the injection device, and a housing memory operable in use to record the medicament data. I O

25. A housing according to claim 24, the housing further comprising a display device.

26. A housing according to claim 25, wherein the display device can viewed 15 from the interior of the housing, or can be reversed so as to be viewed from the exterior of the housing, at the selection of a user.

27. A housing according to any one of claims 25 or 26, wherein said housing is book-like, and said display device is in one cover thereof. 0

28. A housing according to any one of claims 24 to 27, wherein said housing comprises a user input means, by which a user can input data to be stored in the housing memory. 5 29. A housing according to any one of claims 24 to 28, further comprising an analysis tool to determine analysis data comprising a physiological measure of a user.

30. A housing according to claim 29 wherein said analysis tool is a glucose 0 meter, and the physiological measure is a blood sugar concentration.

31. A housing according to claim 29 or claim 30 wherein the analysis tool is integrated with the housing.

32. A housing according to any one of claims 29 to 31 , wherein the analysis data is stored in the housing memory.

33. A housing according to any one of claims 24 to 32, wherein the or a further communication device is operable to transmit medicament data to a server.

34. A housing according to any one of claims 24 to 33, the housing further comprising at least one compartment for storing at least one of: an injection needle; and, a medicament.

35. A housing according to any one of claims 24 to 34, the housing comprising the medicament delivery device of any one of claims 1 to 10.