CA2525538A1 - Device and method for identifying a medical device user - Google Patents
Device and method for identifying a medical device user Download PDFInfo
- Publication number
- CA2525538A1 CA2525538A1 CA002525538A CA2525538A CA2525538A1 CA 2525538 A1 CA2525538 A1 CA 2525538A1 CA 002525538 A CA002525538 A CA 002525538A CA 2525538 A CA2525538 A CA 2525538A CA 2525538 A1 CA2525538 A1 CA 2525538A1
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- Prior art keywords
- person
- medical device
- safety system
- sensor
- command
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/74—Details of notification to user or communication with user or patient ; user input means
- A61B5/7475—User input or interface means, e.g. keyboard, pointing device, joystick
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/117—Identification of persons
- A61B5/1171—Identification of persons based on the shapes or appearances of their bodies or parts thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
-
- G—PHYSICS
- G07—CHECKING-DEVICES
- G07C—TIME OR ATTENDANCE REGISTERS; REGISTERING OR INDICATING THE WORKING OF MACHINES; GENERATING RANDOM NUMBERS; VOTING OR LOTTERY APPARATUS; ARRANGEMENTS, SYSTEMS OR APPARATUS FOR CHECKING NOT PROVIDED FOR ELSEWHERE
- G07C9/00—Individual registration on entry or exit
- G07C9/30—Individual registration on entry or exit not involving the use of a pass
- G07C9/32—Individual registration on entry or exit not involving the use of a pass in combination with an identity check
- G07C9/37—Individual registration on entry or exit not involving the use of a pass in combination with an identity check using biometric data, e.g. fingerprints, iris scans or voice recognition
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
- G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/117—Identification of persons
- A61B5/1171—Identification of persons based on the shapes or appearances of their bodies or parts thereof
- A61B5/1172—Identification of persons based on the shapes or appearances of their bodies or parts thereof using fingerprinting
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/60—General characteristics of the apparatus with identification means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M2230/00—Measuring parameters of the user
- A61M2230/20—Blood composition characteristics
- A61M2230/201—Glucose concentration
Abstract
The invention relates to a medical device provided with an operating element for triggering said medical device. The inventive medical device is characterised by a safety system preventing an erroneous triggering of the device. Said invention also relates to a method for controlling the medical device consisting in determining if the command is given by a person, prior to carrying out it.
Description
WO 2004/107277 PCTtEP20041005038 Device and method for identifying a user of a medical device The present invention relates to a device and a method for identifying a user of a medical device on the basis of person-specific biometric or body-specific features.
In particular, the invention relates to a device and a method for detecting whether a medical device, such as for example an injection device, an infusion device or a measuring device, for example for the concentration of a specific substance, are being operated by a person, it being intended according to a preferred embodiment to establish whether this person is authorized to actuate the device or to instigate a certain action of the device.
In the case of medical devices, such as for example insulin pumps, it is often desired that the operation of such a device can be carried out as unobtrusively as possible, the device being carried for example in the pocket of a pair of pants or under the clothes of a user. If, for example, a bolus is to be triggered "blind", the buttons or switches required for triggering should be easy to feel, so that they can for example even be identified and actuated under clothes.
However, when simple pushbutton switches are used, it is possible for a bolus to be triggered randomly and unintentionally by inadvertent actuation of the switch, for example by putting on a safety belt or by inadvertent impact with an edge of a table.
Furthermore, in the case of medical devices to be actuated by a simple switch there is the risk of persons not authorized to operate the device, such as for example children or persons unexperienced in handling the device, inadvertently or intentionally triggering undesired actions of the device.
It is an object of the present invention to propose a device and a method which make it possible for a medical device to be operated safely and reliably.
The device according to the invention is preferably a medical device, such as for example an infusion device, a pump, an injection device, a pen or a measuring device, for example for measuring the proportion of substance in a liquid, such as for example a blood sugar measuring device, and has an operating element for triggering an action, such as for example the administration of a substance by injection or infusion, for example as a bolus, a safety system being provided according to the invention, in order to prevent unintentional, unauthorized or erroneous triggering of an action and/or to identify at least one person.
In general, the safety system according to the invention may be based on various functional principles, which may be used individually or in combination, in order for example to establish that a person has actuated the medical device, i.e. that the device was not for example erroneously actuated by a safety belt or unintentional impact. Furthermore, the safety system may be designed in such a way that it is checked whether the person who has actuated an operating element is authorized to do so in the first place, so that - if necessary - the performance of the desired action can also be blocked if the person does not have authorization, so that for example children or persons or patients who are not authorized to carry out an action or change a setting, such as for example a change of the dosage of a substance to be administered, cannot intervene in the operating modes or parameters set for example by an authorized physician, such as for example dose distributions.
If a person is identified, the operating modes stored for this person, or for example a treatment plan or therapy program, can be set in the device.
According to one embodiment, the safety system may be formed as a force sensor, the force acting on an operating element, such as for example a switch, being measured. In this case, for example, a limit value of a force to be applied at least and/or applied at most may be provided, so that an action is only triggered if the lower limit value is exceeded and/or not if the upper limit value is exceeded, whereby erroneous triggering, for example by slight impact, is avoided.
Furthermore, it is possible to prescribe a time profile of a force distribution, with which the actual profile, detected by the force sensor, of the force acting on the operating element is compared, so that, for example, only force distributions customary for an actuation by a finger lead to the triggering of a desired action and, for example, no "blind" bolus triggering takes place as a result of inadvertent slight or severe impact or by children, who can usually only exert a small force in comparison with adults.
Tt is similarly possible to use as the safety system a temperature sensor, which measures the temperature present at an operating element, for example during the actuation of the operating element, whereby it can be determined whether the operating element has been actuated for example by a fingertip, which would for instance be at body temperature.
Furthermore, an optical sensor may be used as the safety system, which sensor can for example scan the surface of a finger, for example by laser beams, in order for example to detect whether an operating element has been actuated by a finger, or in order to identify the fingerprint of the finger used for actuating the operating element, in order to check on the basis of the fingerprint the authorization of a person to trigger a certain action.
In general, so-called "fingerprint" sensors, which are based on various functional principles, can be used as the safety system according to the invention. Such fingerprint sensors are known in the prior art and may, for example, also be based on the measurement of a capacitive coupling between the surface of a finger and the sensor, a multiplicity of relatively small capacitance measuring devices being provided on an area on which a fingertip is to be placed, in order to detect the profile of the fingertip and consequently the fingerprint.
Furthermore, for example, a touch screen may be used as the safety system, which screen advantageously also displays information concerning the operating state of the medical device to be operated and/or parameters or operating modes to be set.
A transponder may advantageously be used as the operating element and/or the safety system, which transponder has to be carried by a person and brought into the vicinity of the medical device, from which the transponder detects whether for example the medical device is to be enabled for operation by this person.
It is also possible for the transponder to be implanted in the person, so that a unique assignment of the medical device to a specific person is ensured.
In general, the safety system according to the invention may be formed by one or more of the systems described above, it being possible, to increase operating safety, for two or more safety systems to be provided in the case of one medical device, all of which must be activated or triggered in a prescribed manner, in order for example to carry out an unequivocal identification of a user to check the authorization to operate it.
The safety system according to the invention may also be coupled to the operating element and may be designed in such a way that, before the triggering of an action, a confirmation by an authorized user is required, it being possible for example that, after requesting the triggering of a certain action, an optical and/or acoustic signal is output, indicating to a user that the action to be triggered must now be confirmed before this action, for example the administration of a substance, is performed.
A combination of various safety or switching systems may advantageously be used for the energy-saving operation of a medical device, a first switch or a first safety system that uses little or no energy before the actuation being provided for example, such as for example a toggle switch, which after the actuation switches on at least one further safety system, which has for example an increased energy consumption, in order to check the identity of a person operating the medical device, the more energy-intensive safety system being switched off again if identification is unsuccessful and/or after a prescribed time has elapsed, in order to minimize the energy consumption by the safety system, and consequently for example increase the lifetime of a battery provided in the medical device.
With preference, two simple operating elements, such as for example two switches that are attached at different positions of the medical device and have to be actuated simultaneously or in a prescribed sequence, may also prevent a switch that is inadvertently pressed, for example by impact, already leading to undesired triggering of an action, such as for example the administration of a bolus. In particular, it is advantageous to attach the operating elements on two sides of the medical device, which as far as possible are not simultaneously exposed to the action of a force caused by impact.
The safety system is advantageously capable of identifying at least one person. This may take place for example by the detection of one or more biometric person-specific features. A database in which patterns or general information concerning biometric data of individual persons are stored may preferably be provided, for example in the medical device or separately from this device, the medical device being able for example to access the database via a suitable interface, such as for example a cable, radio or infrared transmission, in order to have comparison or reference data available for comparison with the biometric data actually detected. This makes it possible for example for one or more persons to be unequivocally identified and, for example, to establish whether a person identified in this way is authorized to carry out a desired action, or whether the performance of the action is blocked. For example, biometric data, such as for example the fingerprint or the retinal pattern of a physician authorized to set parameters of the medical device, may be provided in such a database, so that only this authorized person can, for example, set the dose of a substance to be administered from the medical device. Certain action cannot be performed, or only partly, by other persons not stored in the database or stored in the database and provided with a different access authorization, while it is also possible that certain functions can be performed by all persons without identifying these persons or checking their authorization. In such a database, data serving for the identification of one or more persons may also be assigned specific authorization levels.
In the case of one or more sensors provided as the safety system, guides or aligning elements may preferably be provided, with the effect that those parts of a person that are used for the identification of the person are aligned in a prescribed way, in order to obtain comparable data in the case of various measurements. For example, a guide for a finger may be provided, so that a fingertip to be placed on a sensor is always aligned approximately in the same way when it is placed on the sensor. This allows for example the speed of detection of the sensor to be increased, since additional computing time does not have to be used to check whether for instance a detected fingerprint coincides with a reference fingerprint, stored for example in a database, if it is turned.
An optical and/or acoustic output device, such as for example an LED or a loudspeaker, may advantageously be provided, in order for example to indicate the operating state of the medical device or draw attention to commands to be input.
In general, the safety system may be provided in or at the medical device. It is also possible to provide a separate device, which can be coupled to the medical device and can serve for the detection of identification features, such as for example biometric data. In this case, the separate device may be coupled to the medical device for example by means of cable, radio or infrared signals, in order for example to transmit identification data or data for setting the medical device to the latter. Similarly, data can also _ g _ be transmitted from the medical device to the separate device, such as for example data concerning a current operating state or recorded data which specify the operation of the medical device over a prescribed period of time.
According to a further aspect, the invention relates to a method for actuating a medical device, such as for example for triggering the administration of a substance andlor for carrying out a measurement, a checking or identification method being carried out according to the invention to identify whether a person operating the medical device is actually authorized to carry out the desired operating action or to detect whether a person has triggered an operating action in the first place, or whether this operating action has for example been triggered inadvertently not by a person but by impact, the performance of this action then not being commenced.
The invention is described below on the basis of exemplary embodiments. In the drawing:
Figure 1 shows a schematic representation of an embodiment according to the invention of a pump;
Figure 2 shows a flow diagram of a first embodiment of a method according to the invention; and Figure 3 shows a flow diagram of a second embodiment of a method according to the invention.
Figure 1 schematically shows an embodiment of an insulin pump 1 according to the invention, with pump electronics 5, a button 2 for operating the pump 1 and a force sensor 3 for preventing so-called "blind" bolus triggering of the insulin pump 1 being provided. The TnTO 2004/107277 PCT/EP2004/005038 _ g _ button 2 is coupled to the force sensor 3 in such a way that a pressure or a force acting on the button 2 can be detected and can be compared with a prescribed force or a pressure profile after a conversion of the signals detected in analog form in the A/D converter 4 in the pump electronics 5. Consequently, inadvertent actuation of the button, for example by impact, can be detected, since in such a case the force typical for actuation by a finger is not present at the force sensor or a force distribution that is characteristic of manual button actuation or a time profile of the force or of the pressure acting on the force sensor 3 does not coincide with a prescribed value or profile, which is stored for example in the pump electronics 5, so that the erroneous triggering of a bolus can be prevented.
Figure 2 shows a first embodiment of a flow diagram according to the invention for checking the authorization of an operator of a medical device, such as for example a pump for medical substances, for example insulin. In the embodiment shown, the checking of the authorization of a user is carried out separately from the medical device by means of a suitable device, such as for example a PC with a sensor.
A sensor detects image data of a user, in particular data suitable for the identification of a person, such as for example the structure of the retina, a fingerprint and/or other suitable biometric features.
Characteristic details, known as "minutiae", are read out from the detected image data, it being possible to detect characteristic patterns or features by means of an algorithm. Subsequently, a search is carried out in a database, in which corresponding features of authorized persons have previously been stored, to ascertain whether the features determined by the WO 2004!107277 PCT/EP2004/005038 algorithm coincide with the features stored in the database. If this is the case, the person operating the device is recognized from the image data detected by the sensor and authorization information can be made available, defining whether or not certain actions can be carried out by this person.
On the basis of this authorization information, it can be determined for example whether an input command is to be performed and, in the case of absent authorization, an error message can be output. If the person identified in this way is authorized to input the corresponding command, it can optionally be determined in a further step whether the person identified is, for example, a physician or a patient.
So, for example, in the case of identification of a physician who is entitled to input all commands, the command can be passed on directly to the pump coupled to the PC.
If it is established that the PC was operated by a patient, it can be checked in a further step whether or not an allocation provided for the patient has already been used up. If this is so, an error message can be output, whereby, for example, patients can be prevented from administering too much painkiller to themselves.
If the allocation has not yet been used up, the patient is authorized to input the corresponding command, for example to trigger the administration of a specific dose of a substance by the pump, and the command can be transmitted to the pump.
In the pump itself , the command received can either be performed directly or a further check can be carried out in the pump of the command input externally or input directly into the pump. So, for example, it is possible that it is also checked once again in the pump whether or not a patient' s allocation has already been used up, and, dependent on this check, either an error message is output or the command is performed and the allocation available to the patient reduced by the dose given.
It is also possible for information to be transmitted from the pump to the PC, for example concerning the amount of substance given, in order for example also to have in the PC information on infusions triggered directly at the pump.
So, for example, it is possible in the case of patients on painkillers effectively to prevent a user somehow from administering himself an overdose of a painkiller or to eliminate the possibility of inadvertent operation of a medical device, for example by children playing.
Figure 3 shows a flow diagram of a second embodiment of a method according to the invention, an electronic identification device, or a so-called "dongle" being used, in order to check the authorization of a person to operate a medical device, such as for example a pump.
A user inputs a command in the medical device or a device which is coupled or can be coupled to the medical device and is recognized, for example by means of a fingerprint, an enabling code and/or a dongle. It is advantageous, for example, for only one dongle per pump to be provided, so that the pump only accepts the commands sent from the dongle that are provided with the corresponding serial number. Once identification and authorization checking of the user has taken place, the pump can be operated normally without further authorization checks being required. Optionally, a time restriction on the authorization to input commands may be provided, so that inadvertent enabling of a pump is automatically ended after the prescribed time.
Furthermore, it is possible actively to end the acceptance of commands input in the pump, so that, once the pump has been operated by an authorized person, further inputs at the pump can be prevented.
Consequently, the pump can be safeguarded, for example, against actuation by children. Furthermore, it is also possible for a pump to be enabled by a user for use in an office, for example, and the safeguard to be switched on for use at home, for example to protect against unintentional activation by children.
It is also possible for an authorization that allows all actions to be carried out to be provided, for example in the form of a so-called "master key", which is made available for example to physicians or other persons, so that for example any pump can be enabled or set by a physician.
ZnIO 2004!107277 PCT/EP2004/005038 Key to figures Figure 2 1 Image data from the sensor 2 Read out minutiae with algorithm 3 Search in the database 4 User DB
Command input 6 Authorized?
7 no 8 yes 9 Output error message Patientlphysician?
11 Physician 12 Patient 13 Allocation used up?
14 no yes 16 Pass on command to pump 17 Output error message 18 Pump 19 Command received Allocation used up?
21 no 22 yes 23 Allocation decrement 24 Output error message Perform command Figure 3 1 Input command 2 Already enabled?
3 no 4 yes 5 Input authorization 6 Error 7 no 8 Authorization given?
9 yes 10 Enable buttons 11 Carry out settings 12 Switch on safeguard 13 Continue without safeguard 14 Disable buttons
In particular, the invention relates to a device and a method for detecting whether a medical device, such as for example an injection device, an infusion device or a measuring device, for example for the concentration of a specific substance, are being operated by a person, it being intended according to a preferred embodiment to establish whether this person is authorized to actuate the device or to instigate a certain action of the device.
In the case of medical devices, such as for example insulin pumps, it is often desired that the operation of such a device can be carried out as unobtrusively as possible, the device being carried for example in the pocket of a pair of pants or under the clothes of a user. If, for example, a bolus is to be triggered "blind", the buttons or switches required for triggering should be easy to feel, so that they can for example even be identified and actuated under clothes.
However, when simple pushbutton switches are used, it is possible for a bolus to be triggered randomly and unintentionally by inadvertent actuation of the switch, for example by putting on a safety belt or by inadvertent impact with an edge of a table.
Furthermore, in the case of medical devices to be actuated by a simple switch there is the risk of persons not authorized to operate the device, such as for example children or persons unexperienced in handling the device, inadvertently or intentionally triggering undesired actions of the device.
It is an object of the present invention to propose a device and a method which make it possible for a medical device to be operated safely and reliably.
The device according to the invention is preferably a medical device, such as for example an infusion device, a pump, an injection device, a pen or a measuring device, for example for measuring the proportion of substance in a liquid, such as for example a blood sugar measuring device, and has an operating element for triggering an action, such as for example the administration of a substance by injection or infusion, for example as a bolus, a safety system being provided according to the invention, in order to prevent unintentional, unauthorized or erroneous triggering of an action and/or to identify at least one person.
In general, the safety system according to the invention may be based on various functional principles, which may be used individually or in combination, in order for example to establish that a person has actuated the medical device, i.e. that the device was not for example erroneously actuated by a safety belt or unintentional impact. Furthermore, the safety system may be designed in such a way that it is checked whether the person who has actuated an operating element is authorized to do so in the first place, so that - if necessary - the performance of the desired action can also be blocked if the person does not have authorization, so that for example children or persons or patients who are not authorized to carry out an action or change a setting, such as for example a change of the dosage of a substance to be administered, cannot intervene in the operating modes or parameters set for example by an authorized physician, such as for example dose distributions.
If a person is identified, the operating modes stored for this person, or for example a treatment plan or therapy program, can be set in the device.
According to one embodiment, the safety system may be formed as a force sensor, the force acting on an operating element, such as for example a switch, being measured. In this case, for example, a limit value of a force to be applied at least and/or applied at most may be provided, so that an action is only triggered if the lower limit value is exceeded and/or not if the upper limit value is exceeded, whereby erroneous triggering, for example by slight impact, is avoided.
Furthermore, it is possible to prescribe a time profile of a force distribution, with which the actual profile, detected by the force sensor, of the force acting on the operating element is compared, so that, for example, only force distributions customary for an actuation by a finger lead to the triggering of a desired action and, for example, no "blind" bolus triggering takes place as a result of inadvertent slight or severe impact or by children, who can usually only exert a small force in comparison with adults.
Tt is similarly possible to use as the safety system a temperature sensor, which measures the temperature present at an operating element, for example during the actuation of the operating element, whereby it can be determined whether the operating element has been actuated for example by a fingertip, which would for instance be at body temperature.
Furthermore, an optical sensor may be used as the safety system, which sensor can for example scan the surface of a finger, for example by laser beams, in order for example to detect whether an operating element has been actuated by a finger, or in order to identify the fingerprint of the finger used for actuating the operating element, in order to check on the basis of the fingerprint the authorization of a person to trigger a certain action.
In general, so-called "fingerprint" sensors, which are based on various functional principles, can be used as the safety system according to the invention. Such fingerprint sensors are known in the prior art and may, for example, also be based on the measurement of a capacitive coupling between the surface of a finger and the sensor, a multiplicity of relatively small capacitance measuring devices being provided on an area on which a fingertip is to be placed, in order to detect the profile of the fingertip and consequently the fingerprint.
Furthermore, for example, a touch screen may be used as the safety system, which screen advantageously also displays information concerning the operating state of the medical device to be operated and/or parameters or operating modes to be set.
A transponder may advantageously be used as the operating element and/or the safety system, which transponder has to be carried by a person and brought into the vicinity of the medical device, from which the transponder detects whether for example the medical device is to be enabled for operation by this person.
It is also possible for the transponder to be implanted in the person, so that a unique assignment of the medical device to a specific person is ensured.
In general, the safety system according to the invention may be formed by one or more of the systems described above, it being possible, to increase operating safety, for two or more safety systems to be provided in the case of one medical device, all of which must be activated or triggered in a prescribed manner, in order for example to carry out an unequivocal identification of a user to check the authorization to operate it.
The safety system according to the invention may also be coupled to the operating element and may be designed in such a way that, before the triggering of an action, a confirmation by an authorized user is required, it being possible for example that, after requesting the triggering of a certain action, an optical and/or acoustic signal is output, indicating to a user that the action to be triggered must now be confirmed before this action, for example the administration of a substance, is performed.
A combination of various safety or switching systems may advantageously be used for the energy-saving operation of a medical device, a first switch or a first safety system that uses little or no energy before the actuation being provided for example, such as for example a toggle switch, which after the actuation switches on at least one further safety system, which has for example an increased energy consumption, in order to check the identity of a person operating the medical device, the more energy-intensive safety system being switched off again if identification is unsuccessful and/or after a prescribed time has elapsed, in order to minimize the energy consumption by the safety system, and consequently for example increase the lifetime of a battery provided in the medical device.
With preference, two simple operating elements, such as for example two switches that are attached at different positions of the medical device and have to be actuated simultaneously or in a prescribed sequence, may also prevent a switch that is inadvertently pressed, for example by impact, already leading to undesired triggering of an action, such as for example the administration of a bolus. In particular, it is advantageous to attach the operating elements on two sides of the medical device, which as far as possible are not simultaneously exposed to the action of a force caused by impact.
The safety system is advantageously capable of identifying at least one person. This may take place for example by the detection of one or more biometric person-specific features. A database in which patterns or general information concerning biometric data of individual persons are stored may preferably be provided, for example in the medical device or separately from this device, the medical device being able for example to access the database via a suitable interface, such as for example a cable, radio or infrared transmission, in order to have comparison or reference data available for comparison with the biometric data actually detected. This makes it possible for example for one or more persons to be unequivocally identified and, for example, to establish whether a person identified in this way is authorized to carry out a desired action, or whether the performance of the action is blocked. For example, biometric data, such as for example the fingerprint or the retinal pattern of a physician authorized to set parameters of the medical device, may be provided in such a database, so that only this authorized person can, for example, set the dose of a substance to be administered from the medical device. Certain action cannot be performed, or only partly, by other persons not stored in the database or stored in the database and provided with a different access authorization, while it is also possible that certain functions can be performed by all persons without identifying these persons or checking their authorization. In such a database, data serving for the identification of one or more persons may also be assigned specific authorization levels.
In the case of one or more sensors provided as the safety system, guides or aligning elements may preferably be provided, with the effect that those parts of a person that are used for the identification of the person are aligned in a prescribed way, in order to obtain comparable data in the case of various measurements. For example, a guide for a finger may be provided, so that a fingertip to be placed on a sensor is always aligned approximately in the same way when it is placed on the sensor. This allows for example the speed of detection of the sensor to be increased, since additional computing time does not have to be used to check whether for instance a detected fingerprint coincides with a reference fingerprint, stored for example in a database, if it is turned.
An optical and/or acoustic output device, such as for example an LED or a loudspeaker, may advantageously be provided, in order for example to indicate the operating state of the medical device or draw attention to commands to be input.
In general, the safety system may be provided in or at the medical device. It is also possible to provide a separate device, which can be coupled to the medical device and can serve for the detection of identification features, such as for example biometric data. In this case, the separate device may be coupled to the medical device for example by means of cable, radio or infrared signals, in order for example to transmit identification data or data for setting the medical device to the latter. Similarly, data can also _ g _ be transmitted from the medical device to the separate device, such as for example data concerning a current operating state or recorded data which specify the operation of the medical device over a prescribed period of time.
According to a further aspect, the invention relates to a method for actuating a medical device, such as for example for triggering the administration of a substance andlor for carrying out a measurement, a checking or identification method being carried out according to the invention to identify whether a person operating the medical device is actually authorized to carry out the desired operating action or to detect whether a person has triggered an operating action in the first place, or whether this operating action has for example been triggered inadvertently not by a person but by impact, the performance of this action then not being commenced.
The invention is described below on the basis of exemplary embodiments. In the drawing:
Figure 1 shows a schematic representation of an embodiment according to the invention of a pump;
Figure 2 shows a flow diagram of a first embodiment of a method according to the invention; and Figure 3 shows a flow diagram of a second embodiment of a method according to the invention.
Figure 1 schematically shows an embodiment of an insulin pump 1 according to the invention, with pump electronics 5, a button 2 for operating the pump 1 and a force sensor 3 for preventing so-called "blind" bolus triggering of the insulin pump 1 being provided. The TnTO 2004/107277 PCT/EP2004/005038 _ g _ button 2 is coupled to the force sensor 3 in such a way that a pressure or a force acting on the button 2 can be detected and can be compared with a prescribed force or a pressure profile after a conversion of the signals detected in analog form in the A/D converter 4 in the pump electronics 5. Consequently, inadvertent actuation of the button, for example by impact, can be detected, since in such a case the force typical for actuation by a finger is not present at the force sensor or a force distribution that is characteristic of manual button actuation or a time profile of the force or of the pressure acting on the force sensor 3 does not coincide with a prescribed value or profile, which is stored for example in the pump electronics 5, so that the erroneous triggering of a bolus can be prevented.
Figure 2 shows a first embodiment of a flow diagram according to the invention for checking the authorization of an operator of a medical device, such as for example a pump for medical substances, for example insulin. In the embodiment shown, the checking of the authorization of a user is carried out separately from the medical device by means of a suitable device, such as for example a PC with a sensor.
A sensor detects image data of a user, in particular data suitable for the identification of a person, such as for example the structure of the retina, a fingerprint and/or other suitable biometric features.
Characteristic details, known as "minutiae", are read out from the detected image data, it being possible to detect characteristic patterns or features by means of an algorithm. Subsequently, a search is carried out in a database, in which corresponding features of authorized persons have previously been stored, to ascertain whether the features determined by the WO 2004!107277 PCT/EP2004/005038 algorithm coincide with the features stored in the database. If this is the case, the person operating the device is recognized from the image data detected by the sensor and authorization information can be made available, defining whether or not certain actions can be carried out by this person.
On the basis of this authorization information, it can be determined for example whether an input command is to be performed and, in the case of absent authorization, an error message can be output. If the person identified in this way is authorized to input the corresponding command, it can optionally be determined in a further step whether the person identified is, for example, a physician or a patient.
So, for example, in the case of identification of a physician who is entitled to input all commands, the command can be passed on directly to the pump coupled to the PC.
If it is established that the PC was operated by a patient, it can be checked in a further step whether or not an allocation provided for the patient has already been used up. If this is so, an error message can be output, whereby, for example, patients can be prevented from administering too much painkiller to themselves.
If the allocation has not yet been used up, the patient is authorized to input the corresponding command, for example to trigger the administration of a specific dose of a substance by the pump, and the command can be transmitted to the pump.
In the pump itself , the command received can either be performed directly or a further check can be carried out in the pump of the command input externally or input directly into the pump. So, for example, it is possible that it is also checked once again in the pump whether or not a patient' s allocation has already been used up, and, dependent on this check, either an error message is output or the command is performed and the allocation available to the patient reduced by the dose given.
It is also possible for information to be transmitted from the pump to the PC, for example concerning the amount of substance given, in order for example also to have in the PC information on infusions triggered directly at the pump.
So, for example, it is possible in the case of patients on painkillers effectively to prevent a user somehow from administering himself an overdose of a painkiller or to eliminate the possibility of inadvertent operation of a medical device, for example by children playing.
Figure 3 shows a flow diagram of a second embodiment of a method according to the invention, an electronic identification device, or a so-called "dongle" being used, in order to check the authorization of a person to operate a medical device, such as for example a pump.
A user inputs a command in the medical device or a device which is coupled or can be coupled to the medical device and is recognized, for example by means of a fingerprint, an enabling code and/or a dongle. It is advantageous, for example, for only one dongle per pump to be provided, so that the pump only accepts the commands sent from the dongle that are provided with the corresponding serial number. Once identification and authorization checking of the user has taken place, the pump can be operated normally without further authorization checks being required. Optionally, a time restriction on the authorization to input commands may be provided, so that inadvertent enabling of a pump is automatically ended after the prescribed time.
Furthermore, it is possible actively to end the acceptance of commands input in the pump, so that, once the pump has been operated by an authorized person, further inputs at the pump can be prevented.
Consequently, the pump can be safeguarded, for example, against actuation by children. Furthermore, it is also possible for a pump to be enabled by a user for use in an office, for example, and the safeguard to be switched on for use at home, for example to protect against unintentional activation by children.
It is also possible for an authorization that allows all actions to be carried out to be provided, for example in the form of a so-called "master key", which is made available for example to physicians or other persons, so that for example any pump can be enabled or set by a physician.
ZnIO 2004!107277 PCT/EP2004/005038 Key to figures Figure 2 1 Image data from the sensor 2 Read out minutiae with algorithm 3 Search in the database 4 User DB
Command input 6 Authorized?
7 no 8 yes 9 Output error message Patientlphysician?
11 Physician 12 Patient 13 Allocation used up?
14 no yes 16 Pass on command to pump 17 Output error message 18 Pump 19 Command received Allocation used up?
21 no 22 yes 23 Allocation decrement 24 Output error message Perform command Figure 3 1 Input command 2 Already enabled?
3 no 4 yes 5 Input authorization 6 Error 7 no 8 Authorization given?
9 yes 10 Enable buttons 11 Carry out settings 12 Switch on safeguard 13 Continue without safeguard 14 Disable buttons
Claims (12)
1. A medical device (1) with an operating element (2) for triggering an action of the medical device (1), characterized by a safety system (3), which prevents erroneous activation of the device.
2. The device as claimed in claim 1, wherein the safety system (3) is able to establish whether a person is actuating the operating element (2).
3. The device as claimed in one of the preceding claims, wherein the safety system comprises a force sensor, a temperature sensor, an optical sensor, a capacitive sensor, a fingerprint sensor, a touch screen and/or a transponder.
4. The device as claimed in one of the preceding claims, wherein the safety system is able to identify at least one person.
5. The device as claimed in one of the preceding claims, with a database in which information for the identification of at least one person and/or for the authorization level of an identified person is stored.
6. The device as claimed in one of the preceding claims, with an alignment device, which ensures that a biometric feature is detected with a body part in a prescribed positional relationship with respect to a sensor.
7. The device as claimed in one of the preceding claims, with an optical and/or acoustic output device for outputting the operating state of the device.
8. A safety system with a medical device, which is coupled to a safety system (3) to prevent erroneous actuation of the medical device.
9. A method for activating a medical device, wherein before an input command is carried out it is checked whether the command was input by a person and/or the person is identified.
10. The method as claimed in the preceding claim, wherein it is checked whether the person has a previously defined authorization.
11. The method as claimed in one of the two preceding claims, wherein an activation command for a system for checking an input command or a person has to be input before the activation of the system.
12. The method as claimed in one of the three preceding claims, wherein after identification of a person a specific program for the person is carried out.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE10325106.5 | 2003-06-03 | ||
| DE10325106A DE10325106A1 (en) | 2003-06-03 | 2003-06-03 | Device and method for recognizing a user of a medical device |
| PCT/EP2004/005038 WO2004107277A1 (en) | 2003-06-03 | 2004-05-11 | Device and method for identifying a medical device user |
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| EP1631939A1 (en) | 2006-03-08 |
| WO2004107277A1 (en) | 2004-12-09 |
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| US20060132283A1 (en) | 2006-06-22 |
| ES2742495T3 (en) | 2020-02-14 |
| US8717141B2 (en) | 2014-05-06 |
| DK1631939T3 (en) | 2019-08-19 |
| EP1631939B1 (en) | 2019-06-19 |
| DE10325106A1 (en) | 2004-12-30 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Discontinued |
Effective date: 20130320 |