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A medical apparatus with a code reader and a method for operating such apparatus

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Publication number
WO2006084464A1
WO2006084464A1 PCT/DK2006/000070 DK2006000070W WO2006084464A1 WO 2006084464 A1 WO2006084464 A1 WO 2006084464A1 DK 2006000070 W DK2006000070 W DK 2006000070W WO 2006084464 A1 WO2006084464 A1 WO 2006084464A1
Authority
WO
Grant status
Application
Patent type
Prior art keywords
information
user
apparatus
code
device
Prior art date
Application number
PCT/DK2006/000070
Other languages
French (fr)
Inventor
Preben Nielsen
Original Assignee
Novo Nordisk A/S
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06FELECTRICAL DIGITAL DATA PROCESSING
    • G06F19/00Digital computing or data processing equipment or methods, specially adapted for specific applications
    • G06F19/30Medical informatics, i.e. computer-based analysis or dissemination of patient or disease data
    • G06F19/34Computer-assisted medical diagnosis or treatment, e.g. computerised prescription or delivery of medication or diets, computerised local control of medical devices, medical expert systems or telemedicine
    • G06F19/3456Computer-assisted prescription or delivery of medication, e.g. prescription filling or compliance checking
    • G06F19/3468Computer-assisted delivery of medication via infusion or injection
    • G16H10/40
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502User interfaces, e.g. screens or keyboards
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6018General characteristics of the apparatus with identification means providing set-up signals for the apparatus configuration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6063Optical identification systems
    • A61M2205/6072Bar codes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6063Optical identification systems
    • A61M2205/6081Colour codes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00Measuring parameters of the user
    • A61M2230/20Blood composition characteristics
    • A61M2230/201Glucose concentration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic

Abstract

A medical apparatus (1) comprises a code reader (4) for reading a code on an exchangeable component eg on a medical cartridge (2). The user mayinput general information via a device control unit (5) and according to the invention also information telling the system how to overrule a failure in the apparatus to obtain an extremely flexible use of the apparatus because the system need not take into account vital failures made by the user when inputting other information.

Description

A medical apparatus with a code reader and a method for operating such apparatus

The invention relates to a medical apparatus comprising an exchangeable component provided with a readable code, and wherein the apparatus comprises a code reader.

Such medical apparatuses are known eg from WO 2004/097715 that enable transfer of specific information to the medical apparatus eg concerning the contents of the carpule, expiry date, country code, production date, serial number and other information relating to the medicament contained in the carpule.

It is usual that medical apparatuses, in particular those that are configured for dispensing a dosage of a medicament to the body, contain a lock, usually an electronic lock, which becomes operative if it is established that the conditions fall outside certain safety limits that are defined in advance in the apparatus.

It is the object of the invention to provide a medical apparatus by which it is possible to redefine what the consequences are to be in case information is detected in the readable code that involves a transgression of the threshold values encoded into the apparatus. When those features are combined with the fact that it is possible, by means of the above-mentioned novel coding options, to achieve much more information and hence an improved decision- making platform than before, the apparatus is made much more flexible for the user than was possible so far.

US 5,643,212 discloses a comprehensive system in which various alarms can be handled and overruled by doctors and nurses, eg in a hospital. It is a further object of the invention to provide a novel way of handling electronic locks in an apparatus for self-treatment, where the unskilled user accomplishes a novel flexibility with respect to avoiding that the apparatus locks by itself and becomes unable to function.

Simultaneously the invention means that the apparatus becomes more safe in use, since the most recent prior art apparatuses, see eg US 2002/0049480 that feature sophisticated software solutions, rely on the user himself inputting the type of insulin, expiry date, etc. That is not adequately reassuring since diabetics are often visually impaired and may be susceptible to entering erroneous information. The invention is particularly suitable for apparatuses for self-treatment, where it is possible to avoid coding errors since a bar code is read, and wherein a larger range of options is provided for circumventing a lock level. This is accomplished on the one hand by the division into several lock levels and, on the other, by a definition of the respective rules whereby it is possible to assume that even critical parameters cannot possibly be erroneous since they are read from a bar code or the like and not by a visually impaired user.

Several types of irregularities may occur, eg that there is no code on the component or that the code is damaged or that the code reader is faulty, and the apparatus may be configured to respond selectively to the type of error.

Preferably the user information is divided into a number of safety levels, eg on at which the patient himself is able to access and perform changes to the consequences selected by the apparatus. A higher user level may be that the medical doctor prescribes or defines certain scenarios to apply for the patient.

Such scenarios will typically be stored as information in the apparatus, whereby, by use of information encoded onto the component, one is able to select precisely the consequence that was prescribed for a selected scenario.

By the invention it is also enabled to generate a reliable historical data, since it is possible to generate an automatic and reliable logbook containing information on current use and in which circumstances the various locks were circumvented. Such log can be used on the one hand by the authority paying for the treatment to see whether the regimen is obeyed and, on the other, in connection with accidents or complaints in respect of use of the drug.

The invention will now be described in the context of the medial apparatus being an injection device, wherein the component is a carpule or cartridgecarrying encoded information. However, the invention may be used in connection with any kind of a medical device having an insertable cartridge part for delivering a medicament or a substance to a user. Also, the principles underlying the invention may just as well be used in connection with eg an apparatus for transcutaneous measurement of the concentration of a substance in body fluid, in which case the component is an exchangeable electrode that carries encoded information. The latter option also underlines the diversity and the advantages brought about by a combination of error information and user scenarios in a manner that provides a more flexible apparatus to the user.

In the following reference is made to the figures, wherein:

Figure 1 shows an explanatory diagram of one embodiment of the invention; while

Figure 2 shows an example of a matrix for a possible correlation between lock type and lock level in one embodiment of the invention. By way of introduction, some fundamental prerequisites will be explained.

A typical usage scenario for a person suffering from diabetes is to use two or more different types of insulin. Typically a slow-acting type is used mornings and evenings, while a fast-acting type is used in connection with meals. The amount of injected insulin depends on the user's daily activities, where the amount and type of food and exercise are paramount parameters for how much and when insulin is to be delivered. To assist in the assessment of how much insulin is to be administered, the blood glucose level is measured a number of times during the day, and the insulin-intake is adapted in accordance with the result of the measurements.

If the blood glucose level is not regulated and kept low, it will result in grave disorders over time; if the blood glucose level becomes too low it will result in discomfort, spells of unconsciousness and, in the worst event, death. Likewise an excessively high blood glucose level will result in discomfort and, in the worst event, unconsciousness.

All diabetics have relations to medical doctors and nurses who, on the one hand, offer advice and guidance as well as treatment, but who also issue prescriptions and prescribe how much and when insulin is to be taken and how much and when measurements of the blood glucose level are to be performed.

In order to enable doctors and nurses to be updated on how the treatment proceeds, a logbook is to be made of blood sugar measurements and insulin intake.

Based on the course of the treatment, guidelines are set up as to how much insulin is to be taken in various situations. It is a prerequisite for the establishment of a safe and reliable system based on Health-Care-Professionals (HCP) rules that there is reliable information available on which type of insulin is currently being used.

By means of an Intelligent Advisory System (IAS) it is possible to offer advice and guidance to a user on the intake of insulin in order to ensure that the blood glucose level of the user becomes more stable. The lAS-system can be based on a rule base that sets up guidelines; however, it may also be based on a neural network that accumulates knowledge of the user's behaviour based on information on blood glucose, the amount of insulin delivered, and inputting of food and exercise information. Finally the IAS- system can also be a combination of a rule base and a neural network.

It is a prerequisite for establishing a safe and reliable system with lAS-rules that there is reliable information available on which type of insulin was used in the device; in case the system is "fed" with erroneous or unreliable information, the system will become very inaccurate and consequently it becomes useless.

When a code is applied to the insulin cartridge used in the injection device, the code can be used for many purposes, depending on the information it contains.

Examples of information contained in the code include: Type of insulin

Expiry date

Production date, batch and place Country code

The first, obvious use of coding in a device is to prevent use of insulin which is past its expiry date and also to use information on insulin type, injection time and amounts injected to automatically generate a logbook which is to be reviewed at a later stage by doctors or nurses. The automatic logbook is also reliable with respect to its truthfulness, as it does not allow mistakes on the part of the user, nor does it enable embellishments in case of insufficient treatment on the user's part. The country code can be used eg for preventing use of insulin packaged with label information in a foreign language which is different from the native tongue of the user. Production data can be used for logistics control and in connection with complaints and error reporting.

Figure 1 shows an explanatory diagram of one embodiment of the apparatus according to the invention. The apparatus 1 comprises a chamber for receiving a encoded cartridge 2 provided with a code 3 that can be read by means of a code reader 4. The apparatus also comprises a device control unit 5 that contains a number of programmes that define in further detail how the user can or may react in connection with the intake of insulin by means of the encoded cartridge 2. So-called Health Care Professionals (HCP) or Intelligent Advisory Systems (IAS) are known, but according to the invention such systems are combined with the information that can be read from the encoded cartridge.

Figure 2 exemplifies various kinds of information from the encoded cartridge, viz: no read, past expiry date, country code, and wrong drug. Below these indications in Figure 2, max/min limits, HPC- and IAS-rules are given that represent typical parameters in HCP- and IAS-rules. According to the invention, a number of different types of lock levels are provided that are shown as columns in Figure 2. According to the invention the rules, which are known per se, are expanded by new rules that presuppose the use of the novel feature; viz that information is automatically received from the cartridge code reader, thereby enabling the automatic system to make decisions based on correct basic information and such that the user himself is able, in case of certain types of errors, to overrule the error and hence thus to change lock level in a given situation. Preferably the system is also configured such that a doctor or hospital is able to input permissions into the system, meaning that it is also possible to allow circumventions from a locked situation that the user would otherwise not himself be able to circumvent. Below follows some rather specific examples of the above subject-matter described within the contexts of figures 1 and 2.

In addition to the above-mentioned advantages, a combination of coding, lock and rules makes it possible to generate an automatic and reliable logbook containing information on current use and in which circumstances the various locks were circumvented. Such information can be used, on the one hand, by the authority paying for the treatment to see whether the treatment regimen is being observed and in connection with accidents or complaints related to use of the drug.

A treating doctor inputs a number of rules for a user into the device; the rules may concern insulin type, amount and time. They may also be connected to each other to the effect that one type and amount interval may be administered only for a specific time interval. On the part of the treating doctor, programming can also be made as to which locks the user is to meet if the user desires to break the rules: if it is the time interval which is circumvented by one hour for a specific type of insulin, the case may be that an ACCEPT LOCK (see Figure 2) is merely to appear, whereas - in case a six-hour shifting is concerned - it may be that a CODE LOCK is encountered, where the user needs to obtain a code from the treating doctor to break the rule. Likewise, rules may be established with the respect to which amount it is desired to take; if the amount is below the interval it may be an ACCEPT LOCK, while it may be an ADVANCED LOCK or CODE LOCK if the amount exceeds the interval. The above programming can be accomplished by any type of interaction with the device including wired or wireless interaction, a keyboard provided on the device, or by using information encoded on the cartridge and transferred to the device by means of the code reader of the device. Also, the code reader of the device may be adapted to interact with a specific component provided with encoded information related to the programming, wherein the specific component is administered by the HCP and wherein the component is used exclusively for programming the device.

One example of a pattern of use is that slow-acting insulin is administered mornings and evenings; additionally, fast-acting insulin is administered three to five times during the day - typically in connection with meals. It is a critical point if one were to make mistakes as to the different types of insulin; in particular it may be fatal to take fast-acting insulin in the evening before bedtime. One may imagine that rules are made for the slow-acting insulin, according to which it is allowed to take the insulin only during a period of time in the morning and in the evening, with different restrictions to amount intervals for mornings and evenings, respectively. Likewise, it is an option to establish rules for the fast-acting insulin, where a rule may be that it is not allowed to take any for a time interval in the evenings, during the night and in the mornings. Likewise, there may be restrictions with respect to the total amount of fast-acting insulin to be delivered during a day and a maximum limitation to the amount per injection and a limitation to the number of injections.

It will be understood that the options described above give the user unprecedented flexibility. So far such flexibility has been regarded as too risky, since - previously - the user has had to encode certain important information about the drug and since the consequences of erroneous readings can be life-threatening. If a lock occurs in the user decision support system, the lowest level may be DISPLAY LOCK, where the user is informed to the effect that a rule is about to be broken and that the user can press any key to continue; for the most basic rules it may be a GUIDED LOCK, where the user is guided through a menu, where the user is to accept throughout the menu.

Another lock-incident is that of the expiry date being exceeded. In that case it may be obvious to programme an IMPOSSIBLE LOCK, where the drug is not to be used in any circumstances; but as the case may be, the device may also be programmed to the effect that the user himself is to accept that he is well aware that he is about to do something which is not entirely correct by means of an ACCEPT LOCK and then he is responsible himself for that course of action.

The invention involves further advantages in combination with the previously mentioned lAS-systems which are self-learning; that means that the system obtains knowledge of the behaviour and treatment regimen of the user. The self-learning system can now be configured such that it operates more reliably and faster since it is no longer necessary to take into account that the user may have inputted erroneous information. Simultaneously it is possible to accomplish additional and sophisticated flexibility by the self-learning system, since it may give the user access to a number of options that comprise possible circumvention of the usual rules, since there is no need to take into account any mistakes that the user may cause by having himself to input information as was the case with the prior art systems.

Example 1

An exemplary embodiment of the invention may include a medical delivery device for self-treatment, the device comprising means for receiving a cartridge having coded information, means for reading coded information from a cartridge when said cartridge is received into said device, means for controlling the operation of the device in correspondance with said coded information and means for presenting status information with respect to the operation of the medical delivery device. Further, the device includes means for locking the operation of the device if a not allowed condition occurs, and the device is provided with means for selectively choosing different unlocking conditions in order to circumvent a locked condition. In order to unlock the device, the unlocking conditions has to match selectively chosen rules that has been preprogrammed into the device upon initiation of the operation.

A method of using such a device may include the steps of:

- providing the medical delivery device,

- selecting rules for unlocking the device,

- inserting a cartridge provided with coded information into the device, - reading said coded information with the code reader for programming the operation of the device,

- locking the operation of the device if an error occurs and presenting a locked condition to the user,

- inputting user information, - unlocking the operation of the device if the user information corresponds to the selected rules for unlocking the device.

Claims

C l a i m s
1. A medical apparatus for self-treatment comprising an exchangeable component which is provided with a readable code, and wherein the apparatus comprises a code reader and a device control unit for controlling the apparatus in accordance with the read code and for providing an electronic lock, if the conditions of the apparatus fall outside certain safety limits, characterised in that the electronic lock comprises a plurality of various lock levels and associated rules of decisions and that the device control unit is configured for receiving user information comprising possible circumvention of a lock level and configured for responding to the read code in a manner that depends on the user information.
2. A medical apparatus according to claim 1 , characterised in that the circuit is configured for being able to record a number of types of irregularities.
3. A medical apparatus according to claim 1 or 2, characterised in that the user information is divided into several safety levels.
4. A medical apparatus according to claims 1-3, characterised in that the circuit also depends on user scenarios that are stored in the apparatus.
5. A medical apparatus according to claims 1-4 and wherein the apparatus is a measuring device for transcutaneous measurement of the concentration of a substance in body fluid, characterised in that the component is an exchangeable electrode that carries encoded information.
6. A medical apparatus according to claims 1-4 and wherein the apparatus is an injection apparatus, characterised in that the component is a carpule that carries encoded information.
7. A medical apparatus according to claims 5 or 6, characterised in that the encoded information is provided as one or more codings selected from the group consisting of conventional bar code, two-dimensional code, RFID or colour code.
8. A medical apparatus according to claims 1-7, characterised in that the code on the component comprises information regarding one or more items of information, such as insulin type, expiry date, production date, batch and place, and country code.
9. A medical apparatus according to claims 1-8, characterised in that it contains a memory for storing information on current use and circumvention of a given type of lock.
10. A method for overriding an electronic lock in a medical apparatus for self- treatment said apparatus comprising an exchangeable component which is provided with a readable code and wherein the apparatus comprises a code reader and a device control unit for controlling the apparatus in accordance with the read code and for providing said electronic lock if the conditions of the apparatus fall outside certain safety limits, characterised in that the user inputs user information in case of a lock and the electronic lock is arranged in a number of lock levels having corresponding rules for overriding the respective lock level in dependence of the lock level, the read code and the user information.
11. A method according to claim 10 characterised in that the user information is divided into a number of safety levels according to the users skill.
PCT/DK2006/000070 2005-02-08 2006-02-08 A medical apparatus with a code reader and a method for operating such apparatus WO2006084464A1 (en)

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