MXPA01005388A - A medical system and a method of controlling the system for use by a patient for medical self treatment - Google Patents

Abstract

This invention relates to a system for self treatment. The system consists of several portable modules where one of the modules is designated as a master module. The master module controls, supervises and monitors all the mutual information and data exchange between itself and the rest of the modules. The modules can e.g. consist of a BGM, a doser, an inhaler, a tablet dispenser and a storage container. The modules may be able to generate and store data which is transmitted to the master module if it is within range and active. If the master module is not within range, the data is kept locally in the module until the master module is available or a new master module is designated. The master module or another specific module can send the data to an external unit like a computer or database for further processing. A physician or an expert care-team can access the data in the database and give guidance to the patient on the basis of these processed data. This processing could also be done automatically by utilization of an expert system.

Description

MEDICAL SYSTEM AND METHOD FOR CONTROLLING THE SYSTEM FOR USE BY A PATIENT FOR MEDICAL ATOOTRATION Field of the Invention The present invention relates to a medical system and to a method for controlling the system for use by a patient for a medicinal self-treatment.

Background of the Invention For several years it has been possible to purchase various devices for the treatment of diabetes, for example to inject insulin, for the measurement of blood sugar (such as a device that is referred to as BGM hereafter), to extract samples from blood, and other devices or accessories, the purpose of which is to make it possible for the patient to treat his illness discreetly and with a high standard of safety. Many diabetic patients are elderly people who can easily feel insecure about medical equipment. It is very reassuring and therefore very important that the user can have a system feedback which confirms to the user that all things are fine Ref.129564 from the technical function of the system to the physiological condition of the patient. This broadens the physiological safety net under the patient, which contributes to improving the quality of life of patients who have a disease such as diabetes. Also many young people need to ensure for themselves that the equipment is in order, that is, calibrated, connected to the energy, updated and ready in another way to be operated. One way to ensure that all the necessary things are ready and at hand is to construct several of the necessary devices together in a single integral unit, see for example US Patent No. 5,536,249 and No. 5,593,390. This is not an ideal solution since a multifunctional device is usually very complex with respect to manufacturing and use. People need to be familiar, safe and confident in the use of a self-treatment device which does not provide such an integral multifunctional device. Another disadvantage of integrating several functions in a device is that due to the commercial markets the manufacturer never integrates all the possibilities, but only the most important, so that they are relevant for a sufficiently large group of users. The functions which are not integrated thus should be provided by means of separate apparatuses typically of different fabrications, which can easily create uncertainty as to whether the apparatuses will work correctly together. Additionally, the functionality and the individual devices of an integral multifunctional device are very difficult if not impossible to update without having to update the whole. According to the invention, the individual devices can be arranged or adapted for several respective functions relevant to the treatment for example of diabetes, such as: a lancet device, a body fluid analyzer, one or more apparatus for the administration of drugs, to administer a predetermined dose of medication to the patient. In addition, there are a number of other auxiliaries which the diabetic patient uses, for example test strips for the blood analyzer, needles, wipes for rubbing the blood, an additional cartridge of insulin, glucose tablets, containers for the waste, etc. The object of the invention is to provide a method for effectively verifying the relevant electronic data for a plurality of devices / units which are used by a patient for the self-treatment of a disease, so that a greater level of safety is obtained , both functionally and emotionally, and an effective feedback to the patient. This is achieved in accordance with the invention because the individual apparatuses are provided with electronic communication equipment so that the apparatuses - when in a state of mutual communication - frequently exchange information between them. By means of this a greater functional security can be achieved and the total capacity of the data can be increased, so that the possibility of feedback, for example that the system verifies that each device is working properly and is properly adjusted and that the patient is provided with a number of possible choices to decide in a given situation, is increased. More particularly, the invention relates to a method for controlling the information of the data between a plurality of portable devices for use by a patient for medical self-treatment, the treatment includes a first operation and at least one second operation, the devices portable devices comprise a first apparatus for performing the first operation, and at least one second apparatus for performing the second operation, wherein each apparatus belonging to medical self-treatment has means for one or more of the following functions: storage, transmission, reception, processing and display of the information, a communication of the data attempted between the apparatuses is initiated upon request, the communication is controlled by a functional master module, and the functional master module is designated between at least two of the apparatuses. The request or request can be initiated for example by a timer or other external events such as the patient performing an action. The invention provides the special effect that a patient does not need to carry a large apparatus technically complicated in their use to treat their disease, but that the apparatus can be divided into several smaller and simpler units capable of communicating with each other. The individual units may be optionally adapted to be mechanically interconnected, as described in Danish Patent Application No. PA199800714. According to the invention, all the devices do not need to be active for the communication that is going to be established between some of the apparatuses. This requires that all the devices are adapted to a specific communications protocol, there being several options in this regard. For example, one of the units can be provided with the program information of a higher priority with respect to the control and verification of the communication of the data between the individual devices and that is * 1 designated as the functional master module, where the highest priority program information can already be activated or transferred to the designated functional master module. The highest priority unit can be turned off very well by the user or communication can be interrupted, because the devices can be adapted to communicate directly with each other and store the information, which is subsequently transmitted to the highest priority unit when it is in communication with another device again. Preferably a protocol in which a number of potential master modules (higher priority unit) is predefined. These predefined potential master modules are given a hierarchical priority and the potential master module with the highest priority between the activated and present potential master modules becomes the functional master module. This master module collects the information of the other present and activated devices. In this way, when the user selects one of the devices and carries them with him for a shorter or longer period of time, he still has a group / subset of relevant devices for his own treatment which communicate / exchange information with each other , wherein the designated functional master module is responsible for the control of the communication between the subset of the apparatuses. The functional master module can receive and store / reflect all the information provided by / on the individual devices for backup purposes, and to process and collect the information and for the easier update with a master, total module (one with the hierarchical priority higher), since it contains a reflection of all the information / data. Additionally, the functional master module is responsible for controlling the transmission of the relevant data, for example received from other devices, to the appropriate device (s). If the functional master module does not become available, the individual devices can only store the information locally until the master module becomes available or starts the designation of a new functional master module, ie one with the highest available priority. US Patent Specification 5,204,670 describes a verification and identification system which has a master module which transmits the information collected from different sensors to a central system for further processing. The possibility of using programming modules and physical elements to implement a flexible system is mentioned, but once the modules have been selected, the system and the configuration remain fixed. Patent WO 98/02086 describes an inspection and measurement system in which a single terminal is installed in a patient's house with a data collector and where a central control unit collects the information from a number of terminals (located in different houses). Neither of the two specifications describes a system in which a portable assembly, for example a subset of apparatuses, can communicate and exchange information relevant to self-treatment of a disease, each other, and therefore do not provide a flexible system with a functional safety more large and better feedback possibilities that arise from the mutual exchange of information between devices. Alternatively, other communication protocols can be implemented, such as: A protocol for a network of self-organization where each device transmits all the information received until the device or devices for which the information was intended, receive it. In this way each device functions as a relay station or as a functional master module and storage temporary information transmitted. This structure is especially useful when the configuration of the network is not known or when the configuration of the network changes in an unpredictable way. Another characteristic of a network of this kind is that a maximum number of redundant transmission paths with a separator are created so that the system can transmit the information to the devices that were not available when the information was transmitted. A protocol where all the devices transmit their information without any supervision of any kind. The devices themselves have to decide what information is relevant to them. One device / unit, for example the highest total master / priority module unit, is preferably adapted to communicate with a larger, central, external communication / central system, which may contain a database for the patient. Such additional use of the invention is known for example from U.S. Patent Specification. No. 5,204,670 or WO 98/02086, which, however, can not offer the patient the safe and flexible use of a set of different devices with a mutual communication according to the invention, which are used together in the treatment of an illness.

The apparatuses according to the invention communicate and process the information such as: the amount of medicament, the type of medicament, the concentration of the relevant substances in the body, for example the level / concentration of the body fluids, the dater clock, the amount of food (for example the quantity or units of carbohydrates), the measurement of physical activity, the notification (for example, alerts and warnings) for the patient, the characteristics of the body (for example weight, blood pressure) , etc.) and inventory logistics. This ensures that the relevant information, for example for a drug delivery system similar to a dispenser, ie the number of insulin units, the type of insulin and the time and date for administration, can be stored, displayed, received and transmitted to and from all relevant devices. The doser could then receive the information regarding a predetermined number of units of insulin to be administered and automatically set the amount of the drug to be administered by the electromechanical means. In this way the elderly and disabled people do not have to adjust the relevant amount of medication by themselves but only activate the doser.

Other types of drug delivery systems similar to an inhaler adapted to deliver a dose of medicament in an air stream or a tablet dispenser may be included in place of or in combination with the dispenser. The inhaler and / or the tablet dispenser can also communicate with the other units for the relevant information similar to the dispenser according to the invention. Additionally, different types and apparatus manufactures can be similarly provided for example to a simpler back-up dispenser, which for a shorter period replaces one of the dispensers normally used for example temporarily out of service, a suitable special dispenser particularly for sports, for example that is stronger or more resistant, or devices which have different color and / or design schemes (for example for children, etc.). It is especially useful to transmit data from all devices to the device responsible for communication with external systems for the maintenance of security, calibration, synchronization and updating of data and possible transmission, for example, to an external unit similar to a PC or database for the acquisition, storage and processing of additional data. In this way the patient, a doctor or an expert team in the care of the patients can obtain the behavior during the course of the patient's time, and a verification of compliance with a diet or treatment given to the patient by a doctor or doctor can be made. an expert team in the care of the sick. This could also be done automatically. Additionally, it is also possible for the patient to manually enter information about the treatment. This information can be historical information as well as information about a future scheme (behavioral configuration) such as planned physical exercise, insulin administration, admission of food and other medications. This information can be collected and served as well as an electronic diabetes diary or it can be used to notify the patient through the means of reception as to whether the planned actions are dangerous or not. It is evident that since the apparatus is to be carried by the patient, there is a potential lack of space for an advanced input device, for example, a keyboard. Therefore, the information which can not be introduced in a standardized form, for example the comments of the staff about the treatment, they are typed into the apparatus by the patient using a single entry device once and subsequently can be chosen from a list if necessary again. The patient can also receive the recommended amounts of medicine, exercise, food, etc., from a doctor, an expert team or automatically. Additionally, since only one unit provides a connection or link between the system and any external systems, the major advantage that only one unit needs to be updated with respect to external communication protocols, etc., if the specifications of external systems, is achieved. All the devices in the system can exchange the information so that any device (or at least every device within the range) is updated with the total information, so that each bit of information is reflected for better security and backup, but preferably a particular apparatus is still the link with any of the external systems. This demands a greater amount of total memory capacity for the system, but with the price (and size) always falling from the memory modules, this may be irrelevant. Alternatively, the individual devices are updated just with the information relevant to them and send their information to one in total or to a unit temporarily with the highest priority, ie the functional master module. The invention also relates to a medical system for use by a patient for medical self-treatment, the treatment includes a first operation and at least a second operation, the apparatus comprises a first apparatus for performing the first operation and a second apparatus for effecting the first operation. the second operation, wherein each apparatus comprises means for storing, processing and / or displaying the information, and comprises the means for transmitting and receiving the information so that each apparatus is capable of exchanging the data with any of the other apparatuses that belong to self-treatment, at least two of said devices are a potential functional master module, one of the potential functional master modules is designated as the functional master module, and so that the functional master module is adapted to control an attempted data communication, initiated upon request, between the devices. For a BGM of one embodiment of the invention, the relevant information could be the time and date for the measurement, the level / concentration of the measured blood glucose that could be stored or transmitted to another device. For a dispenser according to one embodiment of the invention, the relevant information could be the type of medication (for example, long-acting or short-acting insulin), the number of units of insulin that are to be administered and the time and date of administration. This information could be either manually adjusted by the patient or remotely controlled by a doctor, an expert team in the care of the sick or automatically. For an inhaler according to one embodiment of the invention, the relevant information could be the type of medication, the number of medication units to be administered and the time and date of administration. This information could be either manually set by the patient or remote controlled by a doctor, an expert team in caring for the sick or automatically. For a storage container according to one embodiment of the invention the relevant information could be used to monitor the contents of the container so that each time an object (for example the cartridge, the needle, etc.) is used, the container Storage will update the inventory listing. This list could be transferred to a higher priority unit immediately or later, which in turn updates the total content of the objects for the patient, so that the system could notify the patient when he must order a new provision or existence of the objects. The order could also be done automatically by the system if the inventory list is transferred to an external unit, which improves the confidence, comfort and safety of the patient. For a tablet distributor according to one embodiment of the invention, the relevant information could be the number of tablets distributed, the number of tablets remaining, the distribution time and the type of the tablets distributed. The distributor could store and / or communicate this information to a higher priority available unit or other units within the range of communications. A preferred embodiment according to the invention is described in detail below. This particular embodiment is understood only with an example of the invention and should not limit as such the scope or protection. In the preferred embodiment a simple, specific communications protocol has been chosen to simplify the explanation of the invention. In a chosen protocol, a predefined device is chosen as the highest available priority unit (functional master module) which controls, coordinates and verifies the communication of mutual data between all the devices including the device itself. The master module collects or reflects all the data stored in the other devices. This collected or reflected data can then be redistributed to the total master module, any of the other devices and / or an external unit (for example a personal computer or a database system) for retrieval and / or further processing. According to the invention, the portable system can operate even if the total master module is not present, since all of the relevant apparatuses comprise the internal storage means, so that they can store the relevant information when it is stored. obtained and transmitted when they reach the total master module one more time and transmits it, as described above, to the functional master module. Preferably, the information obtained is maintained in the apparatuses so that the patient on request can always be informed of the measurements and / or the most recent information obtained or received. A person skilled in the art could easily implement other communication protocols such as those described above. In this mode a cover unit for a dispenser has been designated as the functional master module but any device could have been chosen in the same easy way. Preferably, the master module will be the device that the patient carries most frequently. BRIEF DESCRIPTION OF THE DRAWINGS The invention will now be explained in detail, with reference to Figures 1-12, in which: Figure 1 shows a prior art dispenser with a conventional lid; Figure 2 shows a dispenser and lid with a BGM, a lancet device and a container for the attached or fixed test strips; Figure 3 shows a lid with a BGM, a lancet device, a container for the fixed test strips and an additional container together with the useful / necessary additional amounts; Figure 4 shows a lid with one BGM and two dispensers; Figure 5 shows an inhaler; Figure 6 shows a tablet dispenser; Figure 7 shows a schematic functional diagram of a BGM according to an embodiment of the invention; Figure 8 shows a schematic functional diagram of a dispenser according to an embodiment of the invention; Figure 9 shows a schematic functional diagram of a higher priority unit (functional master module) according to an embodiment of the invention; Figure 10a shows a flowchart illustrating an apparatus that generates new data (e.g. a BGM) and how the apparatus behaves with respect to the generation of the data and communication according to an aspect of the invention; Figure 10b shows a flowchart illustrating an apparatus that generates new data (eg a BGM) and how the apparatus behaves with respect to the generation of data and communication according to another aspect of the invention; Figure 11 illustrates the general concept according to one embodiment of the invention with respect to communication; Figure 12 illustrates two dispensers and their communication routes.

Detailed description of the invention Figure 1 shows a doser 20 of the prior art and a lid 10. The dispenser 20 comprises a rotating wheel 21 for adjusting either electronically or manually, the level / amount of medicament to be administered, and a screen 22 showing the amount usually selected from a drug that is to be administered. The doser 20 has processing means and storage facilities, similar to a CPU and RAM, for the storage of the data, similar to the time, date and quantity of the drug of the last pair of administrations. This information can be displayed on screen 22 on request. The dispenser 20 further comprises a cartridge (not shown) containing the medicament, and is equipped with a needle 27 through which the medicament is administered. The dispenser 20 has a transparent window 25 so that the amount of medicament left in the cartridge can be easily identified. The lid 10 can be equipped with the dispenser 20 so that a single compact unit and the protection of the doser 20, the needle 27, etc., is obtained. Figure 2 shows a dispenser 20 with a lid 10 where the lid 10 is designated as the functional master module. The dispenser 20 corresponds to the dispenser 20 shown in Figure 1 but with the additional feature that it has transmission, storage and reception means 12 shown schematically. This makes it possible for the dispenser 20 to transmit the stored data, ie the time, date, quantity and type of medicament, to the functional master module 10 for storage and presentation through the receiving means 12 of the master module. The information of the last pair of administrations (time, date, type and amount of medication) can then be easily observed on screen 11 of the master module. If the master module 10 is not present or active, for example if the user has turned it on or has switched it off, the doser 20 will only store the information locally or designate a new functional master module until the master module 10 becomes available. available and the patient will be able to observe the information on the doser 20. The doser 20 can also receive the information through the receiving means 12 from the master module 10. This information could be for example a predetermined quantity of the medication delivered to remote control by a doctor, an expert team in caring for the sick or automatically, for example according to a stored regimen. The information received is then used to automatically set the correct amount of the medication to be administered so that the patient has no concerns about this aspect, which is a great advantage if the patient is a new user, an elderly patient or a patient with disabilities.

Also shown is a BGM 30 which has the means 34 for inserting the test strips 52 which contain a sample of the blood, for the analysis by the BGM 30 operating the buttons 36. The result of the analysis is stored and either displayed on the screen 32 or transmitted to the master module 10 through the transmission means 12 for storage and presentation on the screen larger 11. The patient can observe the last pair of results at the same time over a period of time. A container 50 for the test strips is provided for storage / securing of the test strips 52 in the space 55 and can be added / fixed through the fixing means 31. With this addition, a test strip 52 always will be available. Also shown is a lancet device 40 removably attached to the BGM 30 or to the container 50 for the test strips by the fixing means 31. This lancet device 40 is used by first loading the lancet device through the handle 44 and then pressing button 42, which releases the lancet, piercing the skin, so that a blood sample can be obtained. With this inclusion, the lancet device 40 is always at hand. This has the advantage that a lancet device 40 is always available, to take a blood sample and apply it to a test strip 52. The test strip 52 can then be inserted through the means 34 into the BGM 30, which will start the analysis of the blood sample and, after the complement of the analysis, will show the result on the screen 32. It is very useful to have the BGM 30 and the lancet device 40 fixed together in a compact unit, placed that a BGM 30 could not be used normally without the lancet device 40, whereby the discomforts and uncertainties of using multiple devices of perhaps different fabrications are avoided. On the other hand, if the user already has a lancet device and is accustomed to and familiar with the use of this particular lancet device, he or she can still use this original lancet device and only use the remaining items, which will be a compact package which consists of a dispenser 20 and a BGM 30 and if a container 50 is preferred for the test strips; the cost will be reduced by this. Figure 3 shows the same units that are shown in Figure 2, but instead of a dispenser 20, a container unit 60 with a relatively large space 69 is now provided for storing the items needed each day for self-treatment. For a diabetic person, for example such articles could be a wipe 61 for wiping excess blood after a sample has been taken, a waste container 62 for receiving used items, an extra cartridge 63 which could contain another type of insulin, the reserve needles 27 for the doser, the reserve lancets 65 for the lancet device 40, some glucose in the form of glucose tablets 64, etc. In some situations and in certain forms of diabetes, the injection of insulin can be replaced by the administration of pills which can be stored in the container, thus replacing the previously described dispenser. All these articles, or some more relevant for a given situation, could be kept in the space 69 of the container for a facilitated recovery, when necessary. The container unit 60 is provided with transmission, reception and storage means 12. These means are used to communicate an inventory list to the master module 10 'on which the user can observe and update the inventory list by means of the buttons 36. This list could be transferred to an external unit (for example a computer, a small laptop, a battery-operated microcomputer that fits in the palm of the hand, etc.) immediately or later, which could update a list of the contents of the patient's total objects, so that the system could notify the patient when he must order a new provision of the objects. The order could also be done automatically by the system. In this way the patient will not have to be aware if he has all the objects necessary for a future extension of time or not, which greatly improves the confidence and safety of the patient. Figure 4 shows a lid with one BGM and two dispensers. The lid 10 and the BGM 30 correspond to the units previously described in relation to Figures 2-3. Two dosers 80, 90 of a smaller size than the doser 20 shown in Figures 2-3 but with similar functionality are also shown. The two dosers 80, 90 can contain two different kinds of insulin, for example the insulin of rapid and prolonged activation. In this way a user can have all the necessary devices ready at hand for a future extension of time, for example, a weekend trip, etc., in a very compact way. The user can thereby administer the long-acting insulin from one of the dosers 80, 90 to balance his glucose level on a longer time scale and use the BGM 30 on a regular basis to see if he needs any insulin from short or rapid actuation and administer it according to the use of the other doser, which can provide a predetermined dose of the medication based on the communication with the BGM 30 through its respective means of communication 12. Additionally, the individual dispensers 80, 90 can communicate and exchange the data with each other according to one of the aforementioned protocols, thereby reflecting their locally stored information, so that each unit belonging to the self-treatment system is alert or unless you are able to receive the information and the status of the others. This also has the effect that only one of the dosers 80, 90 needs to exchange the information with a unit responsible for the total collection of the information, located for example in the user's home. Alternatively, the two dosers 80, 90 can be two dispensers similar to the doser 20, each with its own lid 10, or be different in its shape, shape and / or color, for example a strong or resistant sports doser, etc. , or one of the dosers 80, 90 can be a pen / dispenser of • simpler reserve which is a mechanically operated pen, simple, but with means of communication, storage, processing and / or display. The simplest pen can be taken for example on vacation if for example the accessibility of the energy for recharging is problematic, since it uses less power or energy, or just as a backup system. In this way, a user can select the preferred dispenser for a given situation without having to suffer discomfort about loading, acting, etc., of the information, since the dispenser will automatically communicate with the other dispenser, the other units and / or with the functional master module when these are within the operational field of the communication and are available. Figure 5 shows an inhaler 501. The inhaler comprises a nozzle 502 for administration of a predetermined dosage of the medicament to the patient. The predetermined dosage may either be specified by the patient via the buttons 504 or be automatically set from the information received through the receiving means (not shown) for example from the functional master module. Feedback similar to the inhaled dosage, and other relevant information similar to the previous inhaled dosages and the corresponding dater clock, etc., can be displayed to the patient on screen 503. After inhalation, information similar to inhaled dosage can be stored locally and / or transmitted for example to the functional master module by the storage and transmission means (not shown), respectively. Figure 6 shows a tablet dispenser 601. The tablet dispenser 601 is used to administer a tablet of medication to a patient for example to regulate the glucose level of a patient with diabetes. Other distributors of tablets that contain different types of medication can also be included in the system. The tablet dispenser 601 is preferably operated by a single large button 602, whereby the administration of the medicament becomes very easy and safe. After administration, a tablet information may be displayed on screen 603 along with other relevant information and feedback to the patient. The type and amount of the distributed tablets can also be stored and / or transmitted for example to the functional master module by the storage and transmission means (not shown), respectively. Information similar to the type and quantity of medication that is to be distributed may also be received through the reception means (not shown). If the type of loaded tablets is known by the system, a verification can be made that if the type satisfies the recommended type and a warning or warning can be issued if the result of the verification is negative. Figure 7 shows a schematic functional diagram of a BGM_ according to an embodiment of the invention. The BGM cots of the following functional blocks: "Controller", "Receiving Media", "Transmission Media", "Storage Media", "Display or Display Media", "Media Input", and "Measurement of the Concentration / Level of Blood Glucose ". The central block is the functional block "Controller" which coordinates, verifies and controls the tasks of all the other functional blocks as well as the process information. The "Reception Means" and the "Transmission Media" are respole for the reception and transmission of the information data, respectively. The block "Blood Glucose Concentration / Level Measurement" performs the measurement of the concentration / level of blood glucose, for example during a test trip, which contains a blood sample. The "Display or Display Media" can display the relevant information to the patient, for example, the result of a measurement and a clock that contains the time and date of the measurement. The result of the measurement can be stored in the "Storage Media" for later retrieval and also to be sent to other devices (for example the functional master module) through the "Transmission Media". All of these tasks are carried out under the supervision and coordination of the "Controller" block. The BGM according to one embodiment of the invention could be operated in the following manner. When a request for a measurement of blood glucose concentration / level is made either by the patient through the "Input Means" or by another device through the "Reception Means", the controller receives the request and activates the "Blood Glucose Level / Concentration Measurement" block, which initiates and measures the level of blood glucose when the patient inserts a test strip with a sample of blood in a slot on the device. Previously a calibration of the measuring equipment could be done by the insertion of a calibration test strip. The result and a measuring clock are then transferred to the storage means, and the controller can send the result through the transmission means to another device, preferably the functional master module if it is active and within the range of operation. All of these functional blocks could be implemented by the standard / prior art components. The block labeled "Controller" could be implemented for example by any type of CPU, microprocessor, microcontroller, EEPROM or ROM that contains the programs, or the microprogramming, etc. The "Storage Media" functional block could be a standard RAM. The BGM is only one example of an apparatus that could be used in accordance with this invention. Any other bodily fluid analyzer could be used for example a lipid monitor or the like. Figure 8 shows a schematic functional diagram of a dispenser according to an embodiment of the invention. The dispenser consists of the following functional blocks: "Controller", "Receiving Media", "Transmission Media", "Storage Media", "Display or Display Media", "Input Media", and "Media Management". a dose of medication. " These functional blocks correspond to the blocks previously described for the BGM in Figure 7, except for the block "Administration of a dose of the drug", and therefore they will not be explained once again. The functional block "Administration of a drug dose" administers a dose of the medication for example insulin. The amount of the medication could be set by the patient by means of the "Means of Entry" or it can be fixed electromechanically by the "Controller" block according to the information received through the "Reception Means". This information could be prescribed by a doctor, by an expert team for the care of the sick or automatically, so that elderly or disabled people may have to activate only the doser through the means of entry to be administered a medication dose. After activation of the doser, information for example of the type of the medication (for example prolonged or short-acting or long-acting insulin), the quantity of the medication and the corresponding time stamp (date and time) is stored in the Storage Media "and transmitted to an apparatus (preferably the functional master module). Other drug delivery devices other than an insulin doser could be used in accordance with the invention. These could be for example an electronic inhaler, distributors of the tablets, devices that administer growth hormones, etc. One could also have a device that obtains information from orally obtained medication in a manner sar to OHA (Oral Hyperglycochemical Agent). This might require, however, that the user manually enter the type and quantity of the medication, which could be done by icons of choice, the selection of an object in a predetermined list or the typing of the information by alphanumeric keys. Preferably, a predetermined list could require that the user only enter (for example by the icons or alphanumeric keys) the relevant text once and then only present to the user the text already entered and only the task for the quantity and type (which it could also be pre-introduced in the same way). Figure 9 shows a schematic functional diagram of a functional master module according to an embodiment of the invention. The master module consists of the following functional blocks: "Controller", "Receiving Media", "Transmission Media", "Storage Media", "Display or Screen Means", "Input Means", and "External Function". These functional blocks correspond to the blocks previously described with reference to Figures 7 and 8, except for the block "External Function", and therefore will not be explained once again. The functional master module is the module responsible for the coordination, supervision, and control of information and the exchange of data between it and all other present and active devices. These devices identify themselves to the master module when they are within the operating field of operation.* l that the master module always knows which devices are present and active. The master module also receives and stores all the information and data generated in the individual devices for retrieval and / or subsequent transmission to an external system / unit (for example a computer or database), for example by means of a specific unit for storage and additional processing. The relevant information can be displayed on the larger screen of the master module and be operated by the patient. Some of the tasks of the master module could be implemented in the external unit and vice versa. The master module could be any of the apparatuses as represented by the "External Function" functional block in Figure 9, but it is in this mode the lid unit 10 shown in Figures 2-4, and has no such external function. Other functions can be easily implemented in this block. Figure 10a shows a flow diagram illustrating an apparatus that generates new data (for example a BGM) and how the apparatus behaves with respect to the generation and communication of the data. In idle mode the device determines whether the generation of data is required or not. If this is the case (for example if the user has inserted a blood glucose measurement strip into the device), the data generation block assumes the priority and complements the ff. procedures associated with the generation of the data (for example the measurement of the blood glucose concentration). After the addition of data generation, the data is stored in the internal memory of the device. After the complement of the generation of the data or after the determination that the determination of the data was not required, the device determines whether communication is required or not - either by the device itself (several criteria can issue the communication request for example a timing event, an interconnection event with the user, etc. .), or by a device different from the device itself (for example a request from the functional master module). If communication is not required, the device assumes its inactive mode. If the communication is required, the device sends a request to the other device within the operational field of action for to identify the device by itself - thus making it possible to establish the present communication environment. Based on the established communication environment, the device identifies whether the functional master module is or is not within the operative field of the device and activates it. Yes the master module is not within the operating field of the * device, the communication is finished and the device returns to its inactive mode. However, if the master module is within the operative field of the apparatus, the apparatus establishes a connection with the master module and identifies itself with the master module. After the identification exchange of the device, it is established whether the master module is updated with respect to the internal data contained in the internal memory of the device or not. If the master module is updated, the data is not transmitted one more time. However, if the master module is not updated with respect to the internal data of the device, the data necessary to update the master module is transmitted from the device to the master module. After the transmission of data is complemented, it is probably established whether the master module contains data relevant to the device which are not present in the device. If this is the case, the master module transmits the relevant data to the receiving means of the apparatus after which the data is stored in the internal memory of the apparatus. After the storage of the received data or if no transmission of the data was necessary, the device returns to its inactive mode and the circle is complemented. Figure 10b shows a flow diagram illustrating an apparatus that generates new data (for example a BGM) and how the apparatus behaves with respect to the generation and communication of the data according to another. < r < aspect of the invention. This flow chart corresponds to one shown in Figure 10a with the exception that the failure to reach the master module leads to verification that it is possible to designate a new functional master module. If the verification that if it is possible to designate a new functional master module also fails, the The device returns to its inactive mode, and if a new functional master module can be designated, a connection is made to the newly designated master module. Figure 11 illustrates the general concept according to an embodiment of the invention with respect to the communication. Here, the system consists of the exemplary portable units: a functional master module, a doser, a BGM, the remote control units: Remote Control Receiver, Expert / Medical Care Team and Stationary Unit and a Communications Interconnection between them. The functional master module could be, for example, another dispenser, an inhaler, etc. The master module controls the information and the flow of data between it and the other devices and collects data and relevant information from all the other portable units. These data and information could be for example the quantity of the medication, the type of medication, the concentration of the body fluid, the time clock (the date and time) and the logistic characteristics of the inventory. Additionally, the patient can manually enter the information and data related to the amount of food, the measurement of physical activity in the manner described above. These data and information can then be transmitted by means of a communication interconnection (which can be built or integrated within the master module) to the external units similar to a database for the acquisition of the data, the data of the patient over the course of time or a computer which the patient uses to be kept informed about his treatment. Alternatively, all the devices could communicate with all the others. If the functional master module becomes unavailable, a new functional master module can be designated among the rest of the active devices. The information in the database can be accessed by a doctor or an expert team for the care of the sick who could easily and quickly verify the compliance, for example, of a diet or a progress / course of treatment. The doctor or the expert team for the care of the sick could send a notification (for example a * 1 alert or warning) to the patient if the data shows an extension of future inappropriate treatment. The patient could also be notified of future support in this way or the receipt of a guide. The system also makes it possible for the doctor or the expert care team to provide the patient with a number of choices regarding a given situation. The patient could be informed for example that the concentration / level of blood glucose is very high and the patient could be presented with choices either to exercise for a given amount of time or to administer a given amount of a given type. of medication. The possibility of the choice makes the patient detect more control in the treatment and improve the therapeutic value of the treatment. This could also be done automatically by the system. Many of the above tasks could be fully automated by the use of an expert system which is fully updated with the patient's data and condition and has access to the patient's behavior over time. Figure 12 illustrates two dosers and their communication routes. The dosers are identical for the typical patient, a doser that contains fast-acting insulin, the other dispenser that contains the long-acting insulin. The dosers comprise a microcontroller and the memory as shown in Figure 8. The dosers are capable of retaining information about the type of insulin they contain. This information can be either obtained by the reading of the dispenser, for example a bar code on the cartridge or the information can be entered by the patient. Thus, the characteristics of the dispenser make it possible for it to hold information about the treatment of insulin (the type of insulin, the size of the dose and the time clock). A dispenser is equipped with a cap unit 73 which acts as a storage container for an additional insulin cartridge, needles, etc. The storage container is able to maintain the record of the contents of the container which makes it possible to keep the inventory list updated, as described at the beginning of this document. The other dispenser is equipped with a cover unit 74 comprising a BMG, a microcontroller and a memory. This makes it possible for the cover unit 74 to house the information about the concentration of the blood glucose (with the time clock). All dosers 71, 72 and cover units 73, 74 comprise an interconnection which makes it possible to exchange the data. In the present example, the functional master module is the cover unit 74 of the BGM, which, in addition to the local interconnection, comprises an interconnection that makes it possible to communicate with the external units by means of standard communication links (RS-232, a wireless local area network, a telephone, a cell phone, a pager, a satellite link, etc.). By means of these communication links, the patient's treatment data can be transferred to the patient's own computer 80 or, for example, from the telephone system 75 to the patient's electronic medical record on a central server 76. From here, the patient You can access the treatment data by the patient, for example from a web page, using a stationary computer 77, a laptop computer 78, a manual computer 79, etc. Apart from the patient, the patient care team can have access to the patient's treatment data. The master unit 74 of the patient can receive the data from the central server 76, in addition to the transmission of the data. This system has the advantage that the system can operate at 3 levels: If one of the devices 71, 72, 73, 74 of the patient is isolated by the means of communication, it will host the data. When the patient's devices 71, 72, 73, 74 * "1" is within the communication distance, the treatment data is transferred to the master unit 74, making it possible for them to provide the patient with a summary of their treatment as well as warnings or alarms if the data shows that a potentially dangerous situation may occur. When the master device 74 is connected to the central server 76 by means of standard communication links, the processing data is transferred to the patient's electronic medical record.This makes it possible for an expert system on the central server to notify the equipment for the care If necessary, the patient care team can send the information back to the user or send help if necessary, and it is well known that due to patient safety, the development of a medical device is a that consumes time The use of a form of local communication between devices 71, 72, 73, 74 of the patient It has the advantage that only the master device 74 needs to be redesigned to continue with the continuous change in the standard communication links.

It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention.

Claims (34)

1. REVTNDICATION
2. 2 Having described the invention as above, the content of the following claims is claimed as property: 1. A method for controlling the information of the data among a plurality of portable devices for use by a patient for a medical self-treatment, the treatment includes a first operation and at least one second operation, the plurality of portable apparatuses comprise a first apparatus for carrying out the first operation and at least one second apparatus for carrying out the second operation, characterized in that: • each apparatus belonging to the medical self-treatment has means for one or more of the following functions: storage, transmission, reception, processing and display of the information, ß a communication of the data attempted between the devices is initiated upon request, the communication is controlled by a functional master module, and ß designate the functional master module enters the menu Both of the devices. A method according to claim 1, characterized in that the information of the program having the highest priority with respect to the control and verification of the communication of the mutual data is stored / activated in the functional master module. ff
3. 3. A method according to claims 1-2, characterized in that the method 5 further comprises the designation of a new functional master module if the present designated master module becomes unavailable.
4. 4. A method according to claims 1-3, characterized in that the communication of 10 the data is carried out as the reception of the data.
5. 5. A method according to claims 2-4, characterized in that the program information of the highest priority is stored / activated in the apparatus which the patient carries most frequently.
6. 6. A method according to claims 1-5, characterized in that the means are preset to handle a common set of representations of the predetermined information and measurement. 20
7. 7. A method in accordance with the claim 6, characterized in that one or more of the presentations of the common set of measurement and information representations are stored in the apparatus and communicate with the functional master module comprising the information of the 25 program of the highest priority by suing the functional master module is within the operational field and ready for Ti communication.
8. 8. A method according to claim 6 or 7, characterized in that the set 5 Common representations of measurement and information is stored as one or more of the following representations:? the amount of the drug ß the type of medicine the concentration of the body fluids M the timekeeper clock M the amount of food ß the measurement of physical activity • the notification 15 ß the logistic characteristics of the inventory U the characteristics of the body (for example , weight, blood pressure).
9. 9. A method according to claims 6-8, characterized in that the common set 20 of the representations of the measurement and information is related to one or more of the following medications: B insulin -i hormones' growth ß OHA (Oral Hyperglycochemical Agent) 25 M HRT (Hormone Replacement Therapy).
10. 10. A method according to any of the previous claims, characterized in that the total master module controls the storage, transmission, reception and display of information from / to an external unit / system.
11. 11. A method according to claim 10, characterized in that the external unit / system is a computer.
12. 12. A method according to claim 10, characterized in that the external unit / system is a database.
13. 13. A medical system comprising a plurality of portable devices for use by a patient for medical self-treatment, the treatment includes a first operation and at least a second operation, the system comprises a first apparatus for carrying out the first operation and a second apparatus for carrying out the second operation, characterized in that: B each apparatus comprises means for storing, processing and displaying the information and comprises means for transmitting and receiving the information so that each apparatus is capable of exchanging data with any of the other apparatuses belonging to self-treatment, at least two of the apparatuses are a potential functional master module, B one of the potential functional master modules is designated as the functional master module, and B the functional master module is adapted to control an attempted data communication, initiated on request, between the apparatuses.
14. 14. A medical system according to claim 13, characterized in that the functional master module comprises the information of the program having the highest priority with respect to the control and verification of the communication of the mutual data between the apparatuses.
15. 15. A medical system of soundness with claims 13-14, characterized in that one of the potential functional master modules is designated as a new functional master module if the designated functional master module becomes unavailable.
16. 16. A medical system according to claims 13-15, characterized in that the functional master module comprises means for storing, transmitting, receiving and / or displaying the information transmitted from the other apparatuses.
17. 17. A medical system according to claims 13-16, characterized in that the means are preset to handle a common set of measurement and information representations.
18. 18. A medical system according to claim 17, characterized in that the apparatuses comprise storage means for storing one or more of the representations of the common set of the information and measurement representations when the apparatus comprising the program information of the Highest priority is outside the communication operational field or is not available.
19. 19. A medical system according to claims 17-18, characterized in that the common set of the representations of the measurement and the information comprises one or more of the following representations: B the amount of the medication B the type of the medication B the concentration of body fluids B the dater clock B the amount of food B the measurement of physical activity B the notification B the logistic characteristics of the inventory B the corporal characteristics.
20. 20. A medical system according to claims 17-19, characterized in that the common set of representations of measurement and information is related to one or more of the following medications: B insulin B growth hormones B OHA (Hyperglycochemical Agent Oral) B HRT (Hormone Replacement Therapy).
21. 21. A medical system according to claims 13-20, characterized in that a complete master module comprises means for storing, transmitting, receiving and / or displaying the information from / to an external unit.
22. 22. A medical system according to claim 21, characterized in that the external unit is a computer.
23. 23. A medical system according to claim 21, characterized in that the external unit is a database.
24. 24. A medical system according to claims 13-23, characterized in that the apparatuses are selected from the group of: a lancet device B a body fluid analyzer B a drug delivery system for administering a predetermined dose of medication to patient B a sensor to obtain bodily characteristics.
25. 25. A medical system according to claim 19 or 24, characterized in that the concentration of the body fluid is the concentration of the blood glucose.
26. 26. A medical sound system with claims 24 or 25, characterized in that the body fluid analyzer is a blood glucose monitor.
27. 27. A medical system according to claim 24, characterized in that the body fluid analyzer is a monitor of the lipids.
28. 28. A medical system according to claims 19-28, characterized in that the bodily characteristics are one or more of the body weight and blood pressure.
29. 29. A medical sonicity system with claim 24, characterized in that the drug delivery system is selected from the group of: B an insulin injection device B an inhaler, and B a tablet dispenser.
30. 30. A medical system according to claims 24-29, characterized in that the apparatus has one or more storage containers for storing a supply of one or more of the following: B a supply of lancets for the analyzer of the body fluids or the blood glucose monitor B a supply of test strips for the body fluid analyzer or the blood glucose monitor B an additional supply (cartridge) of insulin B a supply of needles.
31. 31. A medical system according to claim 26, characterized in that the blood glucose monitor comprises storage, transmission and / or display means for the level of blood glucose and / or the time stamp.
32. 32. A medical system according to claim 29, characterized in that the insulin injection device comprises storage, transmission, reception and / or display means for a number of medication units, the type of medication and / or the watch. dater
33. 33. A medical system according to claim 30, characterized in that the one or more storage containers comprise means of storage, transmission, reception and / or display for the logistics elements of the inventory.
34. 34. A medical system according to any of the preceding claims, characterized in that the system comprises means for the presentation of the selections to the patient for a given situation, the presentation depends on the previous choices of the patient.