WO2011117270A1 - Device and method for providing information for setting up a medical device - Google Patents

Device and method for providing information for setting up a medical device Download PDF

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Publication number
WO2011117270A1
WO2011117270A1 PCT/EP2011/054391 EP2011054391W WO2011117270A1 WO 2011117270 A1 WO2011117270 A1 WO 2011117270A1 EP 2011054391 W EP2011054391 W EP 2011054391W WO 2011117270 A1 WO2011117270 A1 WO 2011117270A1
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WO
WIPO (PCT)
Prior art keywords
user
insulin
medical device
recognized
recognized user
Prior art date
Application number
PCT/EP2011/054391
Other languages
French (fr)
Inventor
Stephan MÜLLER-PATHLE
Original Assignee
Sanofi-Aventis Deutschland Gmbh
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
Application filed by Sanofi-Aventis Deutschland Gmbh filed Critical Sanofi-Aventis Deutschland Gmbh
Publication of WO2011117270A1 publication Critical patent/WO2011117270A1/en

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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
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A61B5/4839—Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
    • 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
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • 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
    • A61B5/1176—Recognition of faces
    • 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
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3125—Details specific display means, e.g. to indicate dose setting
    • 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
    • A61M2205/609—Biometric patient 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
    • 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
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe

Definitions

  • the present invention relates to an apparatus, a method and a computer program for providing information for setting up a medical device.
  • US patent application publication 2009/0136094 discloses a patient identifier system that is adapted to obtain patient data, such as a patient identification number or a patient name, using patient face recognition. Once obtained, the patient data is employed to retrieve medical data, e.g. the patient's medical history, test results or diagnosis information, associated with the patient data. The medical data is then displayed to a healthcare practitioner, such as a doctor or a nurse.
  • patient data such as a patient identification number or a patient name
  • medical data e.g. the patient's medical history, test results or diagnosis information
  • an apparatus comprising a processor configured to recognize a user of a medical device based on an at least partial image of the user of the medical device, the processor being further configured to provide information associated with the recognized user for setting up the medical device.
  • a method comprising recognizing a user of a medical device based on an at least partial image of the user of the medical device and providing information for setting up the medical device, the information being associated with the recognized user of the medical device.
  • a computer program comprising program code for performing the method according to the second aspect of the present invention when the computer program is executed on a processor.
  • the computer program may for instance be storable or encodable on a computer- readable medium.
  • the computer program may for instance at least partially represent software and/or firmware of the processor.
  • a computer-readable medium having a computer program according to the third aspect of the present invention stored thereon.
  • the computer-readable medium may for instance be embodied as an electric, magnetic, electro-magnetic, optic or other storage medium, and may either be a removable medium or a medium that is fixedly installed in an apparatus or device.
  • Non-limiting examples of such a computer-readable medium are a Random-Access Memory (RAM) or a Read-Only Memory (ROM).
  • RAM Random-Access Memory
  • ROM Read-Only Memory
  • the computer- readable medium may for instance be a tangible medium, for instance a tangible storage medium.
  • a computer-readable medium is understood to be readable by a computer, such as for instance a processor.
  • the processor of the apparatus may for instance be embodied as a microprocessor, a Digital Signal Processor (DSP), Application Specific Integrated Circuit (ASIC), Field Programmable Gate Array (FPGA) or the like.
  • DSP Digital Signal Processor
  • ASIC Application Specific Integrated Circuit
  • FPGA Field Programmable Gate Array
  • the processor may execute program code (e.g. software of firmware) stored on a program memory, and may use a main memory, for instance to store intermediate results.
  • the Program memory may for instance be a Read-Only Memory (ROM), and main memory may for instance be a Random Access Memory (RAM).
  • the medical device may for instance be an X-ray apparatus, an ultrasonic device or an analytical apparatus device for analyzing bodily fluids, e.g. blood. Further, the medical device may comprise a processor running a computer program serving a medical purpose.
  • the medical device may thus be a personal computer (PC), for instance provided with a webcam for acquiring an at least partial image of a user working with the software. It may also be a medical device serving a therapeutic purpose, e.g. an irradiation device for radiotherapy, a laser for removing tissue, or any other medical device that may be set-up.
  • the medical device may further be a device for delivering a medicament, for example through injection, such as an injection pen, through infusion, such as an infusion pump, through inhalation, and/or the like.
  • a medicament for example through injection, such as an injection pen, through infusion, such as an infusion pump, through inhalation, and/or the like.
  • the user of the medical device may for instance be a human or animal being for the benefit of whom the medical device is used, in the following referred to as a patient, or a person using the medical device for the benefit of a patient, e.g. a healthcare
  • the at least partial image of the user of the medical device may comprise image information on any part of the body of the user or the body of the user as a whole.
  • the at least partial image of the user may contain image information on said specific body part, thus allowing for recognizing the user based on features of said specific body part.
  • the at least partial image of the user of the medical device may be a two-dimensional or three-dimensional image.
  • the at least partial image of the user may be acquired using any suitable image acquisition technology.
  • Image acquisition may employ an image sensor susceptible to, for example, visible light or infrared wavelength light or the like. Infrared sensors allow for user recognition even in dark surroundings.
  • Ultrasonic sensors or laser scanners can be applied to collect three-dimensional images for recognizing the user of the medical device. For recognizing the user of the medical device, i.e. for user recognition or user identification, methods employing feature extraction, methods employing principal component analysis (PCA), methods employing wavelet decomposition and
  • User recognition may be based on a single at least partial image of the user of the medical device or it may be based on a plurality of at least partial images of the user of the medical device.
  • Recognition information derived from the partial image or images of the user of the medical device may be compared to reference data sets, wherein each reference data set is associated with a certain individual, e.g. a human being or an animal.
  • a metric characterizing the similarity or the difference of recognition information derived from the at least partial image or images of the user of the medical device and reference recognition information of the compared reference data set may be calculated.
  • the individual associated with the data set for which the highest similarity metric and/or the lowest difference metric is calculated may then be determined as the recognized user.
  • the reference data sets may be stored in a reference database that is for instance accessible to the processor of the apparatus according to the first aspect of the present invention.
  • the reference database may in turn be stored on a storage component, e.g. a memory component, forming part of the apparatus comprising the processor or it may be stored on a separate entity, e.g. a server that is wirelessly connectable or
  • the reference data sets may alternatively or in addition to reference recognition information derived from an at least partial image or images of a user of the medical device comprise reference images.
  • a reference image may be directly compared to an at least partial image of a user of the medical device for user recognition purposes. It may also be possible to derive reference recognition information from a reference image each time a comparison is to be performed.
  • the processor of the apparatus being configured to recognize a user of the medical device does not mean that said processor itself has to perform comparison of recognition information derived from the at least partial image or images of the user of the medical device with reference recognition information.
  • the processor initiates transmission of the at least partial image or images of the user to the entity performing reference data set comparison and determining the recognition result, e.g. a server or a component of the apparatus comprising the processor, thus causing user recognition results to be obtained.
  • reference recognition information acquisition may be performed, e.g. in a teaching step.
  • an at least partial image of said user may be acquired, for instance by means of an image sensor also employed for acquiring an at least partial image of a user of the medical device for user recognition.
  • recognition information may be derived from the acquired image so as to obtain reference recognition information corresponding to the recognition information derived from the at least partial image of the user of the mobile device for user recognition at a later stage.
  • a user identifier may be used in the user recognition process.
  • the user identifier may on the one hand be automatically generated and tied to the reference recognition information, the reference recognition information thus becoming associated with the user identifier. It may on the other hand also be input by the user or another person. For instance, if the user is a patient, a healthcare practitioner may input the user identifier.
  • a user interface may be allocated to the processor configured to recognize a user of the medical device.
  • a user identifier may comprise a user name and/or address as well as other information on the user, e.g. the user's date of birth. As another example, it may however also comprise a consecutive number or a randomly generated alpha-numeric code identifying the user.
  • the user identifier and the reference recognition information may be stored together in a reference data set in the reference database. Once a reference data set has been created, said reference data set may be employed from thereon to recognize the respective user.
  • the user recognition result may be presented, e.g. on a display forming part of the apparatus comprising the processor configured to recognize a user of the medical device.
  • the recognition result may then be confirmed by the user or by another person entering a confirmation command via a user interface.
  • This procedure may also be used in case of an ambiguous recognition result, i.e. if two or more alternative recognition results are presented. For instance in case of the value of a similarity metric or a difference metric being nearly equally large for two distinct reference data sets, the user identifiers associated with each of the reference data sets may be displayed for selection.
  • the information associated with the selected identifier i.e. with the selected user who is then treated as the recognized user, may be provided by the processor for setting up the medical device accordingly.
  • the information for the setting up the medical device may also be displayed once it has been provided by the processor.
  • Providing information associated with the recognized user for setting up the medical device may comprise retrieving the information associated with the recognized user based on a user recognition result, e.g. a retrieved user identifier.
  • the processor of the apparatus may be configured to transmit the user identifier to a server.
  • the server may then search a set-up database for information associated with the
  • the recognized user may transmit the information to the processor.
  • the server may or may not also perform the comparison of recognition information derived from the at least partial image or images to reference recognition information.
  • the server may transmit the information associated with the recognized user upon retrieval thereof.
  • the processor of the apparatus according to the first aspect of the present invention thus automatically receives the information associated with the recognized user.
  • the set-up database may be directly accessible to the processor and the processor may itself search the database for the information associated with the recognized user.
  • the information for setting up the medical device may also be directly associated with the reference recognition information, an identifier thus not being needed.
  • a single database may then serve as a reference database and as a set-up database.
  • Providing the information associated with the recognized user for setting up the medical device may for instance comprise forwarding the information associated with the recognized user to an actuator of the medical device that is operable according to the information for setting up the medical device, the information may in this case for instance comprise at least one setting for setting up the actuator.
  • Providing the infornnation associated with the recognized user for setting up the medical device may also comprise presenting, e.g. displaying, the information associated with the recognized user. The user may then manually set the medical device according to the displayed information.
  • providing the information associated with the recognized user may involve providing the information for a calculation taking into account said information in determining a calculation result. The calculation may for instance be carried out by the processor configured to recognize a user of a medical device may or it may be carried out by another processor. Embodiments of the present invention may thus allow providing user-specific
  • the medical device may be set up according to the provided information associated with the recognized user. Since recognizing the user of the medical device is based on an at least partial image of the user, wrongly using information that is in fact associated with another user for setting up the medical device may be prevented. Thus, adverse consequences for a patient's health that may arise from a wrongly configured medical device may not occur. A patient not being able to input identification data, e.g. due to a visual impairment or any other medical condition, may still be identified reliably. At the same time, setting up the medical device manually for the recognized user, which is often error-prone and time- consuming, may not be necessary when using the present invention.
  • the apparatus further comprises an image sensor configured to acquire the at least partial image of the user of the medical device.
  • the apparatus according to the first aspect of the present invention further comprises the medical device.
  • the processor of the apparatus is configured to recognize the user of the medical device by means of face recognition.
  • face recognition a wide spectrum of face recognition approaches may be employed. For instance, a distance between any two points on a face in the at least partial image of a user, such as the distance between two eyes, two ears or the sides of the nose; or the shape of any element in an image, such as a nose, ear, eye, lip, chin line, eye-socket or cheekbone, may be exploited in face recognition.
  • Face recognition may include performing a face detection step for determining the position of the face in the at least partial image of the user of the medical device.
  • An exemplary face detection step may use Hough transform for detecting ellipse shaped objects, which may be a valid assumption for a face.
  • Hough transform for detecting ellipse shaped objects, which may be a valid assumption for a face.
  • the at least partial image of the user of the medical device needs to contain image information at least on a part of the face of the user of the medical device.
  • Face recognition exploits the fact that the face of a user is generally not covered by clothing, thus allowing for reliable user recognition.
  • the processor of the apparatus is further configured to assign the recognized user to at least one user group of at least two user groups.
  • the information associated with the recognized user comprises information associated with the at least one user group the recognized user is assigned to.
  • Each of the at least two user groups may have one or more than one member.
  • the at least two user groups may for instance be different groups of patients for which the medical device is to be used. A certain characteristic of the patient, e.g. the patient's gender, may decide to which group the patient is assigned, thus serving as a grouping criterion. Groups based on a patient's age, weight or illnesses the patient has been diagnosed with may be defined and the patient may be assigned to the group or the groups for which the underlying grouping criterion is met.
  • User groups may also be defined based on the role of the user. For instance, a patient group and a healthcare practitioner group may be defined. There may also be different groups provided for different kinds of healthcare practitioners such as doctors or nurses. Information for setting up the medical device may be associated with the user group and thus with each user assigned to that user group.
  • a required storage capacity for storing information for setting up the medical device may be reduced. Since the information for setting up the medical device associated with the recognized user comprises
  • said latter information does not need to be stored several times separately for each user assigned to the respective user group. It may suffice to store it only once for the respective user group.
  • the information associated with the at least one user group the recognized user is assigned to comprises user authorization information.
  • not every potential user may be authorized to use a medical device.
  • User recognition may allow for determining whether the recognized user has the permission to use the medical device. If it is found that the user is authorized, use of the medical device may be granted. If it is found that the user is not authorized, use of the medical device may be denied and an according message may be provided to the denied user, for instance such a message may be presented on a display or it may be provided acoustically.
  • the user authorization information may be an activation or deactivation setting for the medical device.
  • authorization to use the medical device may only be granted if the recognized user is assigned to a healthcare practitioner user group and it may be denied if the user is assigned to a patient user group.
  • Unsuccessful user recognition e.g. because no reference image or reference recognition information is stored in a reference database, may yield authorization being denied.
  • the user authorization infornnation comprised by the information associated with the recognized user may not only determine whether the recognized user is at all allowed to use the medical device or not.
  • the user authorization information may affect the availability of one function or several functions of the medical device to a generally authorized recognized user while other functions of the medical device are available regardless of the user recognition result.
  • the recognized user is a patient, for instance due to the user being assigned to a patient user group, only basic functions of the medical device may be made available to the user. If it is however found that the user is a nurse, analysis functions of the medical device may be made available to the user. The recognized user being found to be a physician may cause configuration functions of the medical device to be made available to the user.
  • the medical device is a device configured to administer a medicament to a patient and the information associated with the recognized user comprises information relevant for administering the medicament to the recognized user.
  • a medicament also frequently referred to as a "drug” may for instance be understood to be any substance that, when absorbed into the body of a living organism, alters normal bodily function, and/or as any substance used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being of a creature.
  • Non-limiting examples of devices configured to administer a medicament to a patient are an injection device such as an injection pen, an infusion device such as an infusion pump, and/or the like.
  • the information associated with the recognized user may in this context comprise at least one of a dose of a
  • the device configured to administer a medicament to a patient may thus conveniently and safely be configured according to the medical needs of the recognized user even if it is generally used for subsequently administering a medicament to different patients. It may thereby be made sure that the recognized user is administered the correct type of medicament in a suitable dose and according to a recommended time schedule. The optimal medical effect of the administered medicament may thus be obtained.
  • the medical device is an insulin injector.
  • An insulin injector is an example of a device configured to administer a medicament, i.e. insulin, to a patient.
  • An insulin injector may for instance be embodied as an insulin injection pen.
  • two elderly persons may live in a single household, and both are diagnosed with diabetes. They may require different doses and/or different types of insulin, e.g. quick-acting insulin and intermediate-acting insulin. These two persons may commonly use an insulin injector.
  • User recognition based on an at least partial image of the respective user of the insulin injector may in such a scenario make sure that a suitable dose of insulin of the correct type is injected by each person.
  • the insulin injector may in this case also be mechanically locked, e.g. by locking a needle cap covering a needle of the injector or by locking an injection button of the injector.
  • the locked state of the insulin injector may be the basic state of the insulin injector, i.e. the needle cap and/or the injection button may have to be unlocked so as to allow for an injection being performed.
  • the two persons diagnosed with diabetes and living in the same household may also use different insulin injectors. In this case, unsuccessful user recognition, e.g.
  • the processor configured to recognize a user of an insulin injector belonging to a first person of the two persons does not have access to a reference data set associated with the second person of the two persons, may yield presenting a warning to the second person not to use the insulin injector belonging to the first person if the second person tries to do so and/or it may yield locking of the insulin injector. An accidental insulin injector mix-up may thus be prevented. This may also be useful in a hospital
  • the medical device is configured to determine data for a patient and the information associated with the recognized user comprises user related information relevant for determining the data for the recognized user.
  • the medical device may for instance be an X-ray apparatus, an ultrasonic device or an analytical apparatus for analyzing bodily fluids, e.g. blood.
  • User related information relevant for determining the data for the recognized user may for example comprise user related information required for interpreting information acquired by the medical device for the recognized user.
  • analysis may involve determining the value of a certain parameter of a blood sample. For evaluation, said parameter may have to be seen in the context of user related information, such as the user's gender, age, weight or other user related information.
  • Based on the value of the parameter determined by the medical device and based on the user related information data may be determined that may allow for a more straight forward evaluation than the mere agglomeration of the user related information and the value determined by the medical device. Setting up the analytical apparatus according to the user related information may facilitate evaluation as it may allow the analytical apparatus to determine data suitable for the user.
  • user related information relevant for determining the data for the recognized user may in the case of the medical device being an X-ray apparatus comprise information on the weight of the recognized user. Based on the weight of the user, the irradiation dose the user is exposed to may be adjusted, i.e. it may be set-up according to the weight of the user.
  • the data determined by the X-ray apparatus for the recognized user are in this case X-ray image data.
  • the irradiation dose which is in turn dependent on the weight of the recognized user, is relevant for determining the X-ray image data for the recognized user.
  • user related information relevant for determining the data for the recognized user may also comprise information on earlier X-ray examinations of the user for setting up the irradiation dose accordingly.
  • the embodiment presently discussed may allow setting up the medical device according to patient-specific information in an uncomplicated and reliable manner.
  • the data the medical device is configured to determine may comprise at least one of a dose of a medicament to be administered to the recognized user, a type of a medicament to be administered to the recognized user, and a time schedule according to which a medicament is to be administered to the recognized user.
  • the suitable dose and/or the right type of a medicament to be administered to a patient may depend on patient information. Also, the time schedule according to which a medicament is to be administered to the recognized patient may depend on patient information. By recognizing the user and providing information associated with the recognized user for setting up the medical device accordingly, the information
  • Reliable user recognition based on an at least partial image of the user may be of high importance in this context.
  • the medicament is insulin.
  • An increasingly large number of people has to inject insulin due to failing insulin level control.
  • the correct insulin dose, insulin type and time schedule according to which insulin has to be administered varies from patient to patient.
  • the current blood glucose level and parameters such as the weight of the patient, the insulin dose, type and administration time schedule may vary. Therefore, devices configured to determine the insulin dose, type and administration time schedule for a patient, i.e. configured to execute an insulin titration algorithm, exist. They are often referred to as insulin dose calculators or blood glucose monitors. Recognizing a user of such a medical device, i.e.
  • recognizing the patient using the medical device and providing information associated with the recognized user for setting up the medical device, the information associated with the recognized user comprising user related information relevant for determining data for the recognized user by means of the medical device, may then allow determining the insulin dose, type and administration schedule for the respective user even if several users share the medical device.
  • the medical device may be an insulin injector that also has insulin dose calculation / blood glucose monitoring capabilities. In this case, it may determine the insulin dose, type and administration time schedule and may set itself up accordingly. For example, by means of suitable actuators the injector may be automatically charged with the determined dose of insulin of the determined type. If the determined administration time schedule does recommend an insulin injection at the respective point in time, the insulin injector may issue a warning.
  • the medical device comprises a blood glucose meter.
  • This embodiment may enable acquiring information on the blood glucose level of the recognized user by means of the medical device that is also configured to determine at least one of a dose of insulin to be administered to the recognized user, a type of insulin to be administered to the recognized user and a time schedule according to which insulin is to be administered to the recognized user. To determine any of these parameters, information on the blood glucose level of the recognized user may be needed. Users may also consider it convenient if the medical device used for
  • the blood glucose metering device may store metered blood glucose levels associated with the recognized user in a database for later retrieval, for example together with a time stamp.
  • the method comprises setting up the medical device according to the provided information associated with the recognized user.
  • the method comprises acquiring the at least partial image of the user of the medical device.
  • recognizing the user of the medical device comprises recognizing the face of the user of the medical device.
  • the method comprises assigning the recognized user to at least one user group of at least two user groups, wherein the information associated with the recognized user
  • the method comprises information associated with the at least one user group the recognized user is assigned to.
  • the method comprises determining data for the recognized user of the medical device taking into account the information associated with the recognized user.
  • the method may comprise determining, by means of the medical device, at least one of a dose of a medicament to be administered to the recognized user, a type of a medicament to be administered to the recognized user and a time schedule according to which a medicament is to be administered to the recognized user.
  • FIG. 1 a schematic illustration of an apparatus according to a first embodiment of the present invention
  • FIG. 2 a flowchart of a method according to a second embodiment of the present invention
  • Fig. 3a a schematic illustration of the structure of an insulin dose calculator according to a third embodiment of the present invention.
  • Fig. 3b a schematic illustration of an exterior view of the insulin dose calculator of Fig. 3a;
  • Fig. 3c a schematic illustration of a lateral exterior view of the insulin dose calculator of Fig. 3a and Fig. 3b;
  • Fig. 4 a flowchart of a method according to a fourth embodiment of the present invention
  • Fig. 5a a schematic illustration of an insulin injector according to a fifth
  • Fig. 5b a schematic illustration of the insulin injector of Fig. 5a in the presence of a second person
  • Fig. 6 a flowchart of a method according to a sixth embodiment of the present invention
  • Fig. 7 a schematic illustration of a tangible storage medium according to a seventh embodiment of the present invention.
  • Fig. 1 shows a schematic illustration of an apparatus 100 according to an embodiment of the present invention.
  • Apparatus 100 comprises a processor 1 10, which may for instance be a microprocessor, a Digital Signal Processor (DSP), Application Specific Integrated Circuit (ASIC), Field Programmable Gate Array (FPGA) or the like.
  • Processor 1 10 is configured to recognize a user of a medical device based on an at least partial image of the user of the medical device. To this end, processor 1 10 comprises a recognition unit 1 1 1 .
  • Processor 1 10 is further configured to provide information associated with the recognized user for setting up the medical device. To this end, processor 1 10 comprises an information unit 1 12.
  • Fig. 2 shows a flowchart 200 of a method according to a second embodiment of the present invention. The method steps may be performed by a processor such as processor 100 depicted in Fig. 1 .
  • a step 201 comprises recognizing a user of a medical device based on an at least partial image of the user of the medical device.
  • a step 202 information for setting up the medical device, the information being associated with the recognized user of the medical device, is provided. Thereafter, flowchart 200 terminates.
  • Apparatus 100 depicted in Fig. 1 and the method depicted in flowchart 200 shown in Fig. 2 enable recognizing the user of the medical device based on an at least partial image of the user and providing information associated with the recognized user for setting up the medical device. Wrongly using information that is in fact associated with another user for setting up the medical device is therefore prevented. Thus, adverse
  • Fig. 3a shows a schematic illustration of an insulin dose calculator or blood glucose monitor 300 according to a third embodiment of the present invention.
  • the insulin dose calculator 300 comprises a microprocessor 310.
  • Microprocessor 310 executes program code (e.g. software of firmware) stored on a program memory 320, and uses a main memory 330, for instance to store intermediate results.
  • Program memory 320 may for instance be a Read-Only Memory (ROM), and main memory 330 may for instance be a Random Access Memory (RAM).
  • Microprocessor 310 interacts with a camera 340 comprising an object lens 341 and an optical sensor 342, for example a charged-coupled device (CCD) sensor, a
  • CCD charged-coupled device
  • CMOS complementary metal-oxide-semiconductor
  • a liquid crystal display (LCD) 350 is controlled by microprocessor 310.
  • CCD sensor 342 is configured to acquire an at least partial image of the user of insulin dose calculator 300 via the object lens 341 when the user faces a viewing area of LCD 350.
  • camera 340 may be embodied similar to a camera installed in a mobile phone, a web-cam, and/or the like.
  • Microprocessor 310 also interacts with a blood glucose meter 360, which is configured to receive a blood sample (e.g. on a carrier such as a test-strip) of a user of insulin dose calculator 300 and to determine a blood glucose level therefrom, which then is provided to microprocessor 310 for further processing.
  • Insulin dose calculator 300 may receive input information and/or commands, for instance from a user via a user interface 370.
  • insulin dose calculator 300 comprises a storage memory 380 which is in the present case embodied as a flash memory.
  • Microprocessor 310 is configured to access storage memory 380 for writing data to storage memory 380 or reading data from storage memory 380.
  • a reference database 381 and a set-up database 382 are stored on storage memory 380.
  • microprocessor 310 executes the instructions of the program code stored on program memory 320, therein using main memory 330.
  • the instructions cause microprocessor 310 to initiate camera 340 to acquire an image and to analyze the image information consequently provided by CCD sensor 342.
  • This analysis step involves performing face detection on the provided image information. To this end, ellipses are searched for using Hough transform.
  • microprocessor 310 According to the instructions executed on microprocessor 310, if no face is detected camera 340 is controlled by microprocessor 310 to acquire another image after a waiting period of few milliseconds up to several seconds, and face detection is once again performed. This process is repeated until a face has been detected in the image information provided by CCD sensor 342.
  • the instructions executed on microprocessor 310 then cause microprocessor 310 to derive recognition information such as the distance between the eyes of the detected face of the user and the shape of the nose and lips of the detected face of the user of insulin dose calculator 300.
  • microprocessor 310 reads reference data sets from reference database 381 stored on storage memory 380.
  • the reference data sets each comprise reference recognition information that has been previously derived from an at least partial image of the face of a certain user of insulin dose calculator 300.
  • Each reference data set is tied to a user identifier.
  • the user identifier comprises the respective user's name and date of birth as well as a consecutive number assigned to the user by microprocessor 310.
  • microprocessor 310 calculates a similarity metric, i.e. in the present case a metric characterizing the similarity of the reference recognition
  • Microprocessor 310 selects the reference data set for which the similarity metric assumes the highest value. If this value is lower than a predefined threshold, user recognition is considered to have failed. In consequence, the instructions executed on microprocessor 310 cause
  • microprocessor 310 to control LCD 350 to prompt the user to input his name and date of birth via user interface 370.
  • a new reference data set is then created and stored in reference database 381 . If the value of the similarity metric is above the predefined threshold, user recognition is considered to have been successful.
  • Microprocessor 310 controls LCD 350 to display the name of the recognized user. Optionally, the user may be required to confirm via user interface 370 that he has been correctly identified.
  • Face recognition based user recognition exploits the fact that the face of a user of insulin dose calculator 300 is generally not covered by clothing, thus allowing for reliable user recognition.
  • user recognition employs recognition of the retina of a user, recognition of a fingerprint of a user, and/or recognition of any other visually unique feature of a user.
  • microprocessor 310 searches set-up database 382 for information associated with the consecutive number assigned to the recognized user.
  • the information stored for the recognized user comprises the recognized user's weight, age and gender, the type of insulin the recognized user's physician has recommended for said user and information acquired related to the last use of insulin dose calculator 300 by the recognized user, such as the time of the last use, the insulin dose recommended to the recognized user at the last time of use and the recognized user's blood glucose level at the last time of use.
  • Microprocessor 310 then provides the values of these parameters, i.e. the information retrieved from set-up database 382, and the current blood glucose level metered by blood glucose meter 360 to the program executed on microprocessor 310.
  • insulin dose calculator 300 also allows for performing a necessary blood glucose metering step so that a separate blood glucose meter is not needed.
  • the program executed on microprocessor 310 is set up according to the information associated with the recognized user and provided by microprocessor 310.
  • the program determines the dose of insulin the recognized user should inject and the point in time at which this should be done according to an insulin titration algorithm. These parameters are presented to the recognized user on LCD 350 together with the type of insulin.
  • the type of insulin may be programmed into set-up database 382 of storage memory 380 for the user, for example by the user's physician.
  • insulin dose calculator 300 determines data for the recognized user based on information related to the recognized user, the determined data in this case being which dose of insulin the recognized user requires at which point in time.
  • Insulin dose calculator 300 is thus configured to determine data for a patient, i.e. the recognized user.
  • the information provided by microprocessor 310 comprise user related information relevant to insulin dose calculator 300 for determining the data for the recognized user.
  • a group assignment parameter is associated with each user identifier existing in set-up database 382.
  • the group assignment parameter may assume two values. It may either indicate that the respective user is a healthcare practitioner or it may indicate that the respective user is a patient.
  • microprocessor 310 assigns the recognized user to the user groups indicated by the group assignment parameter.
  • Information is associated with each of the two user groups.
  • Microprocessor 310 accesses set-up database 382 stored on storage memory 380 to retrieve the information associated with the user group the recognized user is assigned to. Said information is thus also associated with the recognized user.
  • the information associated with the respective user group is only stored once in set-up database 382. Thereby the required storage capacity is reduced compared to, for instance, storing the group-specific information separately for each user belonging to the respective user group.
  • the information associated with the at least one user group the recognized user is assigned to comprises user authorization information.
  • the recognized user may, according to the user authorization information, determine properties of the insulin titration algorithm used for a certain patient for whom a reference data set is stored in reference database 381 .
  • a healthcare practitioner may also determine and store in set-up database 382 the type of insulin that should be recommended to said patient by insulin dose calculator 300.
  • a healthcare practitioner may perform the initial determination of the insulin dose and the insulin type. These parameters may then be stored in set-up database 382.
  • the user may be identified by a name and date of birth after entry via user interface 370. If the user is recognized in this way, no new reference data set will be created.
  • determining and/or modifying the insulin titration algorithm and the recommended type of insulin may not be done by a user assigned to the patient user group. Thus, a patient may not determine these parameters for herself/himself.
  • the blood glucose metering function of blood glucose meter 360 is made available. A healthcare practitioner does not need to use blood glucose meter 360. The blood glucose metering function thereof is therefore not made available to a recognized user assigned to the healthcare practitioner user group.
  • Fig. 3b shows a schematic illustration of an exterior view of insulin dose calculator 300 of Fig. 3a.
  • the components depicted in Fig. 3a are arranged in a housing 390.
  • a blood sample carrier embodied as a disposable test-strip 395 is inserted in blood glucose meter 360 through a slot provided in housing 390.
  • User interface 370 comprises two keys 371 and 372.
  • Fig. 3c shows a schematic illustration of a lateral exterior view of insulin dose calculator 300.
  • an at least partial image of the face of a user U may be capture by object lens 341 of camera 340 for user recognition.
  • the current blood glucose level may depend on the level of physical activity, consumed food, previously administered doses of insulin, and parameters such as the weight of the patient, the insulin dose, type and administration time schedule.
  • a required insulin dose, insulin type and administration time schedule thus also varies from patient to patient.
  • An insulin dose calculator allows determining a recommended insulin dose, insulin type and insulin injection time schedule for a patient.
  • two or more people in a single household may require treatment for diabetes, for example two or more members of the same family. It may be desirable that they share an insulin dose calculator such as insulin dose calculator 300, for example for
  • an insulin dose calculator may be used for even more than two persons. With insulin dose, type and administration time schedule varying from patient to patient, it is important that the insulin titration algorithm of a shared insulin dose calculator is provided with the correct settings for the respective patient. A wrong recommendation of an insulin dose, insulin type and insulin injection time schedule may have adverse consequence for a patient following said recommendation.
  • insulin dose calculator 300 associated with the recognized user is enabled. It is thereby made sure that a suitable insulin dose, insulin type and insulin injection time schedule is recommended to the user of insulin dose calculator 300.
  • user recognition being based on face recognition, a patient not being able to input identification data, e.g. due to a visual impairment or any other medical condition, may still be reliably identified. If a healthcare practitioner wants to set-up insulin dose calculator 300 for a patient, this may also be achieved without the healthcare practitioner having to input patient identification data and without the healthcare practitioner having to set-up insulin dose calculator 300 manually.
  • Fig. 4 shows a flowchart 400 of a method according to a fourth embodiment of the present invention.
  • the method steps may for instance be performed by insulin dose calculator 300 depicted in Fig. 3a, Fig. 3b and Fig. 3c.
  • a step 401 comprises acquiring an image of the face of a user of an insulin dose calculator.
  • recognition information is derived from the acquired image.
  • the derived recognition information is compared to reference recognition information of reference data sets stored in a reference database in a step 403. Therein, for the reference recognition information in each of the reference data sets the value of a similarity metric is calculated.
  • the largest similarity value of the similarity metric that has previously been calculated is selected. It is checked in a step 405 whether the selected similarity value is larger than a predefined threshold.
  • step 407 the recognition information derived in step 402 is tied to the name and the date of birth the user has input in step 407 and the recognition information is stored in the reference database together with the name and the date of birth. Thereafter, flowchart 400 terminates. If it is found in step 405 that the selected similarity value is larger than the predefined threshold in step 405, user recognition is considered to have been successful. In order to retrieve information associated with the recognized user, a user identifier associated with the reference data set comprising the reference recognition information for which the selected largest similarity value has been calculated in step 404 is read from the reference database in a step 408.
  • Said identifier is then used to retrieve information associated with the identifier stored in a set-up database.
  • a group assignment parameter is associated with each user identifier existing in the setup database. This group assignment parameter may assume two values. It may either indicate that the respective user is a healthcare practitioner or it may indicate that the respective user is a patient.
  • the recognized user is assigned to the user group indicated by the group assignment parameter. With each of the two user groups, user authorization information is associated. The authorization information is retrieved in a step 410 from the set-up database.
  • a step 41 1 the retrieved authorization information and the user- specific information retrieved in step 408 is provided to a software program executed on the insulin dose calculator.
  • the insulin dose calculator is set-up according to the retrieved authorization information in a step 412 so that the recognized user may determine properties of the insulin titration algorithm used for a certain patient for whom a reference data set is stored in the reference database.
  • the healthcare practitioner may determine the type of insulin said patient should use. These parameters may then be stored in the set-up database together with the identifier of said user. For a patient for whom user
  • a healthcare practitioner may perform the initial determination of the insulin dose and the insulin type. These parameters may then also be stored in the set-up database. Determining the insulin titration algorithm and the recommended type of insulin may not be done by a user assigned to the patient user group.
  • the insulin dose calculator is set-up according to the retrieved authorization information in step 412 so that a blood glucose metering function of a blood glucose meter forming part of the insulin dose calculator is made available.
  • the blood glucose metering function thereof is however not made available to a recognized user assigned to the healthcare
  • step 412 also comprises setting up the software executed by the insulin dose calculator according to the infornnation retrieved in step 408.
  • Said infornnation comprises the recognized user's weight, age and gender, the type of insulin the recognized user's physician has recommended for said user and information acquired during the last use of the insulin dose calculator by the recognized user, such as the time of the last use, the insulin dose recommended to the recognized user at the last time of use and the recognized user's blood glucose level at the last time of use.
  • the insulin dose calculator may then determine the dose of insulin the recognized user should inject and the point in time at which this should be done according to an insulin titration algorithm. These parameters may be presented to the recognized user together with the type of insulin recommended by the recognized user's physician for the recognized user.
  • Fig. 5a shows a schematic illustration of an insulin injector 500 according to a fifth embodiment of the present invention in the presence of a first person U1 .
  • Insulin injector 500 is an insulin injection pen. It comprises a housing 510 and contains an insulin container 520, to which a needle 530 can be affixed. The needle 530 is protected by a needle cap 540. Insulin injector 500 further comprises a small LCD 550 and a CCD sensor camera 560. Insulin injector 500 also comprises a processor (not shown) controlling the camera and LCD 550.
  • An insulin dose to be injected with insulin injector 500 can be selected by turning a dosage knob 570.
  • the processor controls LCD 550 to display the selected dose in a dosage display area 551 .
  • the selected dose is displayed in multiples of so-called International Units (IU) wherein one IU is the biological equivalent of about 45.5 g pure crystalline insulin (1/22 mg exactly).
  • An example of a selected dose displayed in dosage display area 551 may for instance be 30 lUs, as shown in Fig. 5a.
  • Insulin injector 500 further comprises an injection button 580. When needle 530 is stuck into a skin portion of a patient, and injection button 580 is pushed, the insulin dose displayed in dosage display area 551 will be injected into the patient's body.
  • the processor forming part of insulin injector 500 is configured to recognize a user of insulin injector 500 based on an at least partial image of the user's face acquired by camera 560.
  • the processor is further configured to provide information associated with the recognized user for setting up insulin injector 500 according to the information.
  • the provided information comprises user authorization information.
  • insulin injector 500 belongs to user U1 .
  • User U1 is the only patient allowed to use insulin injector 500. If the processor recognizes, by means of face recognition, that the user facing object lens 510 is user U1 , the authorization information associated with user U1 is retrieved and provided to a software program executed on the processor. The software program is set-up accordingly.
  • the software program may cause the processor to control LCD 550 to display a check mark in a authorization display area 552, thus indicating to user U1 that he is allowed to use insulin injector 500, and to control an actuator to unlock injection button 580.
  • a second condition has to be met:
  • the provided information associated with the recognized user comprises a time schedule according to which user U1 is to inject insulin.
  • the time schedule has been predefined by the physician of user U1 . Setting up insulin injector 500 according to the predefined schedule causes the software program executed on the processor to control LCD 550 to display a check mark in authorization display area 552 and to unlock injection button 580, only if the predefined timing schedule requires user U1 to inject insulin at the current point in time.
  • a cross may be displayed in authorization display area 552 thus indicating to user U1 that he is not allowed to use insulin injector 500 at that point in time.
  • An acoustic warning may be issued at the same time, for instance by means of a speaker (not shown) integrated into insulin injector 500.
  • injection button 580 may remain in a mechanically locked state. The time schedule is thus information relevant for
  • FIG. 5b shows a schematic illustration of insulin injector 500 of Fig. 5a in the presence of a second person U2.
  • insulin injector 500 belongs to user U1 , user U2, who may also be diagnosed with diabetes but may require a different treatment, for example a different type of insulin according to a different time schedule, is not allowed to use it.
  • user U2 is recognized as user U2 by the processor of insulin injector 500 or if user U2 is not recognized at all, e.g. due to no reference recognition information being available for user U2, a cross is displayed in authorization display area 552 of LCD 550 as shown in Fig. 5b.
  • Injection button 580 may remain in a locked state. User U2 is thus prevented from accidentally using insulin injector 500.
  • Accidentally using insulin injector 500 may have severe medical consequences for user U2 due to the injection of the wrong type of insulin.
  • Insulin injector 500 may comprise an insulin dose calculator such as insulin dose calculator 300 depicted in Fig. 3a, Fig. 3b and Fig. 3c. Microprocessor 310 of insulin dose calculator may then also serve for performing the functions of the above described processor of insulin injector 500. Naturally, only one camera, e.g. camera 340 of insulin dose calculator 300 will be needed. Insulin dose calculator 300 may automatically cause selection of a suitable insulin dose, for instance via a suitable actuator, once user U1 has been recognized. Insulin dose calculator 300 and insulin injector 500 may or may not be arranged in a common housing.
  • an insulin dose calculator such as insulin dose calculator 300 depicted in Fig. 3a, Fig. 3b and Fig. 3c.
  • Microprocessor 310 of insulin dose calculator may then also serve for performing the functions of the above described processor of insulin injector 500.
  • Only one camera, e.g. camera 340 of insulin dose calculator 300 will be needed.
  • Insulin dose calculator 300 may automatically cause selection of a suitable insulin dose, for instance via
  • Fig. 6 shows a flowchart 600 of a method according to a sixth embodiment of the present invention. The method steps may for instance be performed by insulin injector 500 depicted in Fig. 5a and Fig. 5b.
  • a step 601 the user of an insulin injector is recognized based on an at least partial image of the face of the user of the insulin injector. Subsequently, in a step 602, it is checked, whether the recognized user is a user U1 to whom the insulin injector belongs. If the user of the insulin injector is recognized as another user than user U1 or if user recognition is considered to have failed, information is provided to a software program executed on a processor of the insulin injector in a step 602. Therein, the software program is also set-up accordingly.
  • the software program causes a processor of the insulin injector to control a display of the insulin injector to display a cross in a step 603, thus indicating to the user that he/she is not allowed to use the insulin injector.
  • An injection button of the insulin injector may remain in a mechanically locked state. Thereafter flowchart 600 terminates.
  • authorization information and a predefined time schedule is provided to the software program executed on the processor of the insulin injector in a step 604.
  • user U1 is generally allowed to use the insulin injector.
  • the software program is set up in a step 606 to cause the processor of the insulin injector to control the display of the insulin injector to display a cross, thus indicating to the user that he/she is not allowed to use the insulin injector.
  • the injection button of the insulin injector may remain in a mechanically locked state. Thereafter flowchart 600 terminates.
  • the software program is set-up in a step 607 to cause the processor of the insulin injector to control the display of the insulin injector to display a check mark and to control an actuator of the insulin injector to unlock the injection button, thus indicating to the user that he is currently allowed to use the insulin injector.
  • flowchart 600 terminates.
  • the software may provide an option to override the lock of the insulin injector in step 603 or step 606, for example in emergency situations where it is necessary to deviate from the recommended insulin dose or predefined time schedule.
  • Such an emergency situation may include hyperglycemia in this or another patient.
  • Fig. 7 is a schematic illustration of a tangible storage medium 700 (a computer program product) that comprises a computer program 710 with program code 720 according to a seventh embodiment of the present invention.
  • This program code may for instance be executed by a processor such as the processor 100 in Fig. 1 , the microprocessor 310 contained in insulin dose calculator 300 of Fig. 3a, 3b and 3c or in the processor of insulin injector 500 depicted in Fig. 5a and Fig. 5b.
  • storage medium 700 may represent program memory 320 of insulin dose calculator 300 of Fig. 3a, 3b and 3c.
  • Storage medium 700 may be a fixed memory, or a removable memory, such as for instance a memory stick or card.
  • ..medicament means a pharmaceutical formulation
  • the pharmaceutically active compound has a molecular weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, a DNA, a RNA, a antibody, an enzyme, an antibody, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound, wherein in a further embodiment the pharmaceutically active compound is useful for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever,
  • the pharmaceutically active compound has a molecular weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, a DNA, a RNA, a antibody, an enzyme
  • the pharmaceutically active compound comprises at least one peptide for the treatment and/or prophylaxis of diabetes mellitus or
  • the pharmaceutically active compound comprises at least one human insulin or a human insulin analogue or derivative, glucagon-like peptide (GLP-1 ) or an analogue or derivative thereof, or exedin-3 or exedin-4 or an analogue or derivative of exedin-3 or exedin-4.
  • GLP-1 glucagon-like peptide
  • Insulin analogues are for example Gly(A21 ), Arg(B31 ), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin;
  • Des(B28-B30) human insulin Des(B27) human insulin and Des(B30) human insulin.
  • Insulin derivates are for example B29-N-myristoyl-des(B30) human insulin; B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl- LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N- palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-Y-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; ⁇ 29- ⁇ -( ⁇ - carboxyheptadecanoyl)-des(B30) human insulin and B29-N-( -carboxy
  • Exendin-4 for example means Exendin-4(1 -39), a peptide of the sequence H His-Gly- Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe- lle-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.
  • Exendin-4 derivatives are for example selected from the following list of compounds:
  • H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1 -39)-Lys6-NH2,
  • Hormones are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin,
  • Somatropine Somatropin
  • Desmopressin Terlipressin
  • Gonadorelin Triptorelin
  • Leuprorelin Buserelin
  • Nafarelin Goserelin.
  • a polysaccharide is for example a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra low molecular weight heparin or a derivative thereof, or a sulphated, e.g. a poly-sulphated form of the above-mentioned
  • polysaccharides and/or a pharmaceutically acceptable salt thereof.
  • An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium.
  • Pharmaceutically acceptable salts are for example acid addition salts and basic salts.
  • Acid addition salts are e.g. HCI or HBr salts.
  • Basic salts are e.g. salts having a cation selected from alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion
  • R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1 C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10- heteroaryl group.
  • R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1 C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10- heteroaryl group.

Abstract

The invention relates to an apparatus (300) comprising a processor (310). The processor (310) is configured to recognize a user of a medical device (300) based on an at least partial image of the user of the medical device (300). The processor (310) is further configured to provide information associated with the recognized user for setting up the medical device (300). The invention further relates to a method and a computer program for providing information associated with a recognized user for setting up a medical device.

Description

Description
Device and Method for Providing Information for Setting Up a Medical Device
Field of the Invention
The present invention relates to an apparatus, a method and a computer program for providing information for setting up a medical device. Background of the Invention
US patent application publication 2009/0136094 discloses a patient identifier system that is adapted to obtain patient data, such as a patient identification number or a patient name, using patient face recognition. Once obtained, the patient data is employed to retrieve medical data, e.g. the patient's medical history, test results or diagnosis information, associated with the patient data. The medical data is then displayed to a healthcare practitioner, such as a doctor or a nurse.
In today's healthcare environments, patients benefit from the use of a variety of medical devices, e.g. for therapy. These medical devices in many cases may or need to be set- up dependent on the respective user of the medical device. Such a set-up procedure is often time-consuming. Severe consequences for a patient's health may arise from a wrongly configured medical device. Storing user-specific information and retrieving the user-specific information for setting up a medical device may ease medical device configuration only if the correct information is retrieved for the respective user.
Summary of Some Embodiments of the Invention
It is thus inter alia an object of the present invention to provide an apparatus, a method and a computer program for providing information associated with a user of a medical device for setting up the medical device allowing for correct and efficient configuration of the medical device. According to a first aspect of the present invention, an apparatus is disclosed, comprising a processor configured to recognize a user of a medical device based on an at least partial image of the user of the medical device, the processor being further configured to provide information associated with the recognized user for setting up the medical device.
According to a second aspect of the present invention, a method is disclosed, comprising recognizing a user of a medical device based on an at least partial image of the user of the medical device and providing information for setting up the medical device, the information being associated with the recognized user of the medical device.
Accordingly, also an apparatus configured to perform the method according to the second aspect of the present invention shall be considered to be disclosed. According to a third aspect of the present invention, furthermore a computer program is disclosed, comprising program code for performing the method according to the second aspect of the present invention when the computer program is executed on a processor. The computer program may for instance be storable or encodable on a computer- readable medium. The computer program may for instance at least partially represent software and/or firmware of the processor.
According to a fourth aspect of the present invention, furthermore a computer-readable medium is disclosed, having a computer program according to the third aspect of the present invention stored thereon. The computer-readable medium may for instance be embodied as an electric, magnetic, electro-magnetic, optic or other storage medium, and may either be a removable medium or a medium that is fixedly installed in an apparatus or device. Non-limiting examples of such a computer-readable medium are a Random-Access Memory (RAM) or a Read-Only Memory (ROM). The computer- readable medium may for instance be a tangible medium, for instance a tangible storage medium. A computer-readable medium is understood to be readable by a computer, such as for instance a processor. In the following, features and embodiments (exhibiting further features) of the present invention will be described, which are understood to equally apply to the apparatus, method, computer program and computer-readable medium of the present invention described above. In particular, a mentioning that a component is configured or arranged to perform a certain action should be understood to also disclose an according method step of the method according to the second aspect of the present invention and an according program code of the computer program according to the third aspect of the present invention. These single features/embodiments are considered to be exemplary and non-limiting, and to be respectively combinable independently from other disclosed features/embodiments with the apparatus, method, computer program and computer- readable medium of the present invention as described above. Nevertheless, these features/embodiments shall also be considered to be disclosed in all possible combinations with each other and with the apparatus, method, computer program and computer-readable medium of the present invention as described above.
The processor of the apparatus according to the first aspect of the present invention may for instance be embodied as a microprocessor, a Digital Signal Processor (DSP), Application Specific Integrated Circuit (ASIC), Field Programmable Gate Array (FPGA) or the like. For recognizing a user of a medical device and for providing information associated with the recognized user, the processor may execute program code (e.g. software of firmware) stored on a program memory, and may use a main memory, for instance to store intermediate results. The Program memory may for instance be a Read-Only Memory (ROM), and main memory may for instance be a Random Access Memory (RAM).
The medical device may for instance be an X-ray apparatus, an ultrasonic device or an analytical apparatus device for analyzing bodily fluids, e.g. blood. Further, the medical device may comprise a processor running a computer program serving a medical purpose. The medical device may thus be a personal computer (PC), for instance provided with a webcam for acquiring an at least partial image of a user working with the software. It may also be a medical device serving a therapeutic purpose, e.g. an irradiation device for radiotherapy, a laser for removing tissue, or any other medical device that may be set-up. The medical device may further be a device for delivering a medicament, for example through injection, such as an injection pen, through infusion, such as an infusion pump, through inhalation, and/or the like. The user of the medical device may for instance be a human or animal being for the benefit of whom the medical device is used, in the following referred to as a patient, or a person using the medical device for the benefit of a patient, e.g. a healthcare
practitioner, such as a nurse, a carer for the elderly, a physician or a veterinarian. For both human and animal users the at least partial image of the user of the medical device may comprise image information on any part of the body of the user or the body of the user as a whole. In case of the medical device being a device for application on a user's body part, the at least partial image of the user may contain image information on said specific body part, thus allowing for recognizing the user based on features of said specific body part. The at least partial image of the user of the medical device may be a two-dimensional or three-dimensional image.
The at least partial image of the user may be acquired using any suitable image acquisition technology. Image acquisition may employ an image sensor susceptible to, for example, visible light or infrared wavelength light or the like. Infrared sensors allow for user recognition even in dark surroundings. Ultrasonic sensors or laser scanners can be applied to collect three-dimensional images for recognizing the user of the medical device. For recognizing the user of the medical device, i.e. for user recognition or user identification, methods employing feature extraction, methods employing principal component analysis (PCA), methods employing wavelet decomposition and
combinations thereof may be used to name but a few examples. User recognition may be based on a single at least partial image of the user of the medical device or it may be based on a plurality of at least partial images of the user of the medical device. Recognition information derived from the partial image or images of the user of the medical device may be compared to reference data sets, wherein each reference data set is associated with a certain individual, e.g. a human being or an animal. A metric characterizing the similarity or the difference of recognition information derived from the at least partial image or images of the user of the medical device and reference recognition information of the compared reference data set may be calculated. The individual associated with the data set for which the highest similarity metric and/or the lowest difference metric is calculated may then be determined as the recognized user. The reference data sets may be stored in a reference database that is for instance accessible to the processor of the apparatus according to the first aspect of the present invention. The reference database may in turn be stored on a storage component, e.g. a memory component, forming part of the apparatus comprising the processor or it may be stored on a separate entity, e.g. a server that is wirelessly connectable or
connectable by wire to the processor. The reference data sets may alternatively or in addition to reference recognition information derived from an at least partial image or images of a user of the medical device comprise reference images. A reference image may be directly compared to an at least partial image of a user of the medical device for user recognition purposes. It may also be possible to derive reference recognition information from a reference image each time a comparison is to be performed.
With respect to the first aspect of the invention, it is noted that the processor of the apparatus according to the first aspect of the invention being configured to recognize a user of the medical device does not mean that said processor itself has to perform comparison of recognition information derived from the at least partial image or images of the user of the medical device with reference recognition information. For example, it may suffice that the processor initiates transmission of the at least partial image or images of the user to the entity performing reference data set comparison and determining the recognition result, e.g. a server or a component of the apparatus comprising the processor, thus causing user recognition results to be obtained.
For enabling comparison of recognition information derived from an at least partial image or images of the user of the medical device to reference recognition information, reference recognition information acquisition may be performed, e.g. in a teaching step. To this end, whenever the medical device is to be used by or for a user for whom reference recognition information is not available, an at least partial image of said user may be acquired, for instance by means of an image sensor also employed for acquiring an at least partial image of a user of the medical device for user recognition. In another step recognition information may be derived from the acquired image so as to obtain reference recognition information corresponding to the recognition information derived from the at least partial image of the user of the mobile device for user recognition at a later stage.
A user identifier may be used in the user recognition process. The user identifier may on the one hand be automatically generated and tied to the reference recognition information, the reference recognition information thus becoming associated with the user identifier. It may on the other hand also be input by the user or another person. For instance, if the user is a patient, a healthcare practitioner may input the user identifier. To this end a user interface may be allocated to the processor configured to recognize a user of the medical device. As an example for a user identifier, a user identifier may comprise a user name and/or address as well as other information on the user, e.g. the user's date of birth. As another example, it may however also comprise a consecutive number or a randomly generated alpha-numeric code identifying the user. The user identifier and the reference recognition information may be stored together in a reference data set in the reference database. Once a reference data set has been created, said reference data set may be employed from thereon to recognize the respective user.
Once the user has been recognized, the user recognition result may be presented, e.g. on a display forming part of the apparatus comprising the processor configured to recognize a user of the medical device. The recognition result may then be confirmed by the user or by another person entering a confirmation command via a user interface. This procedure may also be used in case of an ambiguous recognition result, i.e. if two or more alternative recognition results are presented. For instance in case of the value of a similarity metric or a difference metric being nearly equally large for two distinct reference data sets, the user identifiers associated with each of the reference data sets may be displayed for selection. The information associated with the selected identifier, i.e. with the selected user who is then treated as the recognized user, may be provided by the processor for setting up the medical device accordingly. The information for the setting up the medical device may also be displayed once it has been provided by the processor.
Providing information associated with the recognized user for setting up the medical device may comprise retrieving the information associated with the recognized user based on a user recognition result, e.g. a retrieved user identifier.
As an example, the processor of the apparatus according to the first aspect of the present invention may be configured to transmit the user identifier to a server. The server may then search a set-up database for information associated with the
recognized user and may transmit the information to the processor. The server may or may not also perform the comparison of recognition information derived from the at least partial image or images to reference recognition information. The server may transmit the information associated with the recognized user upon retrieval thereof. The processor of the apparatus according to the first aspect of the present invention thus automatically receives the information associated with the recognized user. Alternatively, the set-up database may be directly accessible to the processor and the processor may itself search the database for the information associated with the recognized user.
The information for setting up the medical device may also be directly associated with the reference recognition information, an identifier thus not being needed. A single database may then serve as a reference database and as a set-up database.
Providing the information associated with the recognized user for setting up the medical device may for instance comprise forwarding the information associated with the recognized user to an actuator of the medical device that is operable according to the information for setting up the medical device, the information may in this case for instance comprise at least one setting for setting up the actuator. Providing the infornnation associated with the recognized user for setting up the medical device may also comprise presenting, e.g. displaying, the information associated with the recognized user. The user may then manually set the medical device according to the displayed information. To give just one further example, providing the information associated with the recognized user may involve providing the information for a calculation taking into account said information in determining a calculation result. The calculation may for instance be carried out by the processor configured to recognize a user of a medical device may or it may be carried out by another processor. Embodiments of the present invention may thus allow providing user-specific
information for setting up a medical device. The medical device may be set up according to the provided information associated with the recognized user. Since recognizing the user of the medical device is based on an at least partial image of the user, wrongly using information that is in fact associated with another user for setting up the medical device may be prevented. Thus, adverse consequences for a patient's health that may arise from a wrongly configured medical device may not occur. A patient not being able to input identification data, e.g. due to a visual impairment or any other medical condition, may still be identified reliably. At the same time, setting up the medical device manually for the recognized user, which is often error-prone and time- consuming, may not be necessary when using the present invention.
According to an embodiment of the present invention, the apparatus according to the first aspect of the present invention further comprises an image sensor configured to acquire the at least partial image of the user of the medical device.
According to an embodiment of the present invention, the apparatus according to the first aspect of the present invention further comprises the medical device.
According to an embodiment of the present invention, the processor of the apparatus is configured to recognize the user of the medical device by means of face recognition. Therein, a wide spectrum of face recognition approaches may be employed. For instance, a distance between any two points on a face in the at least partial image of a user, such as the distance between two eyes, two ears or the sides of the nose; or the shape of any element in an image, such as a nose, ear, eye, lip, chin line, eye-socket or cheekbone, may be exploited in face recognition. Face recognition may include performing a face detection step for determining the position of the face in the at least partial image of the user of the medical device. An exemplary face detection step may use Hough transform for detecting ellipse shaped objects, which may be a valid assumption for a face. For performing face recognition the at least partial image of the user of the medical device needs to contain image information at least on a part of the face of the user of the medical device.
Face recognition exploits the fact that the face of a user is generally not covered by clothing, thus allowing for reliable user recognition.
According to an embodiment of the present invention, the processor of the apparatus is further configured to assign the recognized user to at least one user group of at least two user groups. Therein the information associated with the recognized user comprises information associated with the at least one user group the recognized user is assigned to.
Each of the at least two user groups may have one or more than one member. The at least two user groups may for instance be different groups of patients for which the medical device is to be used. A certain characteristic of the patient, e.g. the patient's gender, may decide to which group the patient is assigned, thus serving as a grouping criterion. Groups based on a patient's age, weight or illnesses the patient has been diagnosed with may be defined and the patient may be assigned to the group or the groups for which the underlying grouping criterion is met. User groups may also be defined based on the role of the user. For instance, a patient group and a healthcare practitioner group may be defined. There may also be different groups provided for different kinds of healthcare practitioners such as doctors or nurses. Information for setting up the medical device may be associated with the user group and thus with each user assigned to that user group.
By assigning the user to at least one user group a required storage capacity for storing information for setting up the medical device may be reduced. Since the information for setting up the medical device associated with the recognized user comprises
information associated with the at least one user group the user is assigned to, said latter information does not need to be stored several times separately for each user assigned to the respective user group. It may suffice to store it only once for the respective user group.
According to an embodiment of the present invention, the information associated with the at least one user group the recognized user is assigned to comprises user authorization information.
In certain scenarios not every potential user may be authorized to use a medical device. User recognition may allow for determining whether the recognized user has the permission to use the medical device. If it is found that the user is authorized, use of the medical device may be granted. If it is found that the user is not authorized, use of the medical device may be denied and an according message may be provided to the denied user, for instance such a message may be presented on a display or it may be provided acoustically. In this context the user authorization information may be an activation or deactivation setting for the medical device. Combined with providing at least two user groups and assigning the recognized user to at least one user group, the embodiment presently discussed may enable implementation of user group specific authorization. For example, authorization to use the medical device may only be granted if the recognized user is assigned to a healthcare practitioner user group and it may be denied if the user is assigned to a patient user group. Unsuccessful user recognition, e.g. because no reference image or reference recognition information is stored in a reference database, may yield authorization being denied. The user authorization infornnation comprised by the information associated with the recognized user may not only determine whether the recognized user is at all allowed to use the medical device or not. For example, the user authorization information may affect the availability of one function or several functions of the medical device to a generally authorized recognized user while other functions of the medical device are available regardless of the user recognition result. As an example, if it is found that the recognized user is a patient, for instance due to the user being assigned to a patient user group, only basic functions of the medical device may be made available to the user. If it is however found that the user is a nurse, analysis functions of the medical device may be made available to the user. The recognized user being found to be a physician may cause configuration functions of the medical device to be made available to the user.
According to an embodiment of the present invention, the medical device is a device configured to administer a medicament to a patient and the information associated with the recognized user comprises information relevant for administering the medicament to the recognized user. A medicament, also frequently referred to as a "drug", may for instance be understood to be any substance that, when absorbed into the body of a living organism, alters normal bodily function, and/or as any substance used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being of a creature.
Non-limiting examples of devices configured to administer a medicament to a patient are an injection device such as an injection pen, an infusion device such as an infusion pump, and/or the like.
According to an embodiment of the present invention, the information associated with the recognized user may in this context comprise at least one of a dose of a
medicament to be administered to the recognized user, a type of a medicament to be administered to the recognized user and a time schedule according to which a medicament is to be administered to the recognized user. The device configured to administer a medicament to a patient may thus conveniently and safely be configured according to the medical needs of the recognized user even if it is generally used for subsequently administering a medicament to different patients. It may thereby be made sure that the recognized user is administered the correct type of medicament in a suitable dose and according to a recommended time schedule. The optimal medical effect of the administered medicament may thus be obtained.
According to an embodiment of the present invention, the medical device is an insulin injector.
An insulin injector is an example of a device configured to administer a medicament, i.e. insulin, to a patient. An insulin injector may for instance be embodied as an insulin injection pen. For example, two elderly persons may live in a single household, and both are diagnosed with diabetes. They may require different doses and/or different types of insulin, e.g. quick-acting insulin and intermediate-acting insulin. These two persons may commonly use an insulin injector. User recognition based on an at least partial image of the respective user of the insulin injector may in such a scenario make sure that a suitable dose of insulin of the correct type is injected by each person. If a time schedule according to which insulin is to be administered to the recognized user does not recommend an insulin injection at the time of user recognition, a warning may be presented to the recognized user. Alternatively or in addition, the insulin injector may in this case also be mechanically locked, e.g. by locking a needle cap covering a needle of the injector or by locking an injection button of the injector. The locked state of the insulin injector may be the basic state of the insulin injector, i.e. the needle cap and/or the injection button may have to be unlocked so as to allow for an injection being performed. The two persons diagnosed with diabetes and living in the same household may also use different insulin injectors. In this case, unsuccessful user recognition, e.g. because the processor configured to recognize a user of an insulin injector belonging to a first person of the two persons does not have access to a reference data set associated with the second person of the two persons, may yield presenting a warning to the second person not to use the insulin injector belonging to the first person if the second person tries to do so and/or it may yield locking of the insulin injector. An accidental insulin injector mix-up may thus be prevented. This may also be useful in a hospital
environment.
According to an embodiment of the present invention, the medical device is configured to determine data for a patient and the information associated with the recognized user comprises user related information relevant for determining the data for the recognized user.
The medical device may for instance be an X-ray apparatus, an ultrasonic device or an analytical apparatus for analyzing bodily fluids, e.g. blood.
User related information relevant for determining the data for the recognized user may for example comprise user related information required for interpreting information acquired by the medical device for the recognized user. In case of an analytical apparatus for analyzing blood, for instance, analysis may involve determining the value of a certain parameter of a blood sample. For evaluation, said parameter may have to be seen in the context of user related information, such as the user's gender, age, weight or other user related information. Based on the value of the parameter determined by the medical device and based on the user related information data may be determined that may allow for a more straight forward evaluation than the mere agglomeration of the user related information and the value determined by the medical device. Setting up the analytical apparatus according to the user related information may facilitate evaluation as it may allow the analytical apparatus to determine data suitable for the user. As another example, user related information relevant for determining the data for the recognized user may in the case of the medical device being an X-ray apparatus comprise information on the weight of the recognized user. Based on the weight of the user, the irradiation dose the user is exposed to may be adjusted, i.e. it may be set-up according to the weight of the user. The data determined by the X-ray apparatus for the recognized user are in this case X-ray image data. The irradiation dose, which is in turn dependent on the weight of the recognized user, is relevant for determining the X-ray image data for the recognized user. In this context user related information relevant for determining the data for the recognized user may also comprise information on earlier X-ray examinations of the user for setting up the irradiation dose accordingly.
The embodiment presently discussed may allow setting up the medical device according to patient-specific information in an uncomplicated and reliable manner.
According to an embodiment of the present invention, the data the medical device is configured to determine may comprise at least one of a dose of a medicament to be administered to the recognized user, a type of a medicament to be administered to the recognized user, and a time schedule according to which a medicament is to be administered to the recognized user.
The suitable dose and/or the right type of a medicament to be administered to a patient may depend on patient information. Also, the time schedule according to which a medicament is to be administered to the recognized patient may depend on patient information. By recognizing the user and providing information associated with the recognized user for setting up the medical device accordingly, the information
comprising user related information relevant for determining data for the recognized user by means of the medical device, automatic determination of the dose of the medicament to be administered to the recognized user, of the type of the medicament to be administered to the recognized user and of the time schedule according to which a medicament is to be administered to the recognized user may be enabled. Reliable user recognition based on an at least partial image of the user may be of high importance in this context.
According to an embodiment of the present invention, the medicament is insulin. An increasingly large number of people has to inject insulin due to failing insulin level control. The correct insulin dose, insulin type and time schedule according to which insulin has to be administered varies from patient to patient. Furthermore, dependent on the level of physical activity, consumed food, previously administered doses of insulin, the current blood glucose level and parameters such as the weight of the patient, the insulin dose, type and administration time schedule may vary. Therefore, devices configured to determine the insulin dose, type and administration time schedule for a patient, i.e. configured to execute an insulin titration algorithm, exist. They are often referred to as insulin dose calculators or blood glucose monitors. Recognizing a user of such a medical device, i.e. recognizing the patient using the medical device, and providing information associated with the recognized user for setting up the medical device, the information associated with the recognized user comprising user related information relevant for determining data for the recognized user by means of the medical device, may then allow determining the insulin dose, type and administration schedule for the respective user even if several users share the medical device.
The medical device may be an insulin injector that also has insulin dose calculation / blood glucose monitoring capabilities. In this case, it may determine the insulin dose, type and administration time schedule and may set itself up accordingly. For example, by means of suitable actuators the injector may be automatically charged with the determined dose of insulin of the determined type. If the determined administration time schedule does recommend an insulin injection at the respective point in time, the insulin injector may issue a warning. According to an embodiment of the present invention, the medical device comprises a blood glucose meter.
This embodiment may enable acquiring information on the blood glucose level of the recognized user by means of the medical device that is also configured to determine at least one of a dose of insulin to be administered to the recognized user, a type of insulin to be administered to the recognized user and a time schedule according to which insulin is to be administered to the recognized user. To determine any of these parameters, information on the blood glucose level of the recognized user may be needed. Users may also consider it convenient if the medical device used for
determining an insulin dose, type or administration time schedule also allows for performing a necessary blood glucose metering step. The blood glucose metering device may store metered blood glucose levels associated with the recognized user in a database for later retrieval, for example together with a time stamp.
According to an embodiment of the method of the second aspect of the invention, the method comprises setting up the medical device according to the provided information associated with the recognized user.
According to an embodiment of the method of the second aspect of the invention, the method comprises acquiring the at least partial image of the user of the medical device. According to an embodiment of the method of the second aspect of the invention, recognizing the user of the medical device comprises recognizing the face of the user of the medical device.
According to an embodiment of the method of the second aspect of the invention, the method comprises assigning the recognized user to at least one user group of at least two user groups, wherein the information associated with the recognized user
comprises information associated with the at least one user group the recognized user is assigned to. According to an embodiment of the method of the second aspect of the invention, the method comprises determining data for the recognized user of the medical device taking into account the information associated with the recognized user. Therein, according to an embodiment of the method according to the second aspect of the present invention, the method may comprise determining, by means of the medical device, at least one of a dose of a medicament to be administered to the recognized user, a type of a medicament to be administered to the recognized user and a time schedule according to which a medicament is to be administered to the recognized user. Brief Description of the Figures
In the figures show: Fig. 1 a schematic illustration of an apparatus according to a first embodiment of the present invention;
Fig. 2 a flowchart of a method according to a second embodiment of the present invention;
Fig. 3a a schematic illustration of the structure of an insulin dose calculator according to a third embodiment of the present invention;
Fig. 3b a schematic illustration of an exterior view of the insulin dose calculator of Fig. 3a;
Fig. 3c a schematic illustration of a lateral exterior view of the insulin dose calculator of Fig. 3a and Fig. 3b; Fig. 4 a flowchart of a method according to a fourth embodiment of the present invention;
Fig. 5a a schematic illustration of an insulin injector according to a fifth
embodiment of the present invention in the presence of a first person;
Fig. 5b a schematic illustration of the insulin injector of Fig. 5a in the presence of a second person;
Fig. 6 a flowchart of a method according to a sixth embodiment of the present invention; and Fig. 7: a schematic illustration of a tangible storage medium according to a seventh embodiment of the present invention.
Detailed Description of Some Embodiments of the Invention
In the following detailed description, exemplary embodiments of the present invention will be inter alia described in the context of insulin dose calculation and insulin injection. It is however emphasized that deployment of the present invention in this type of system is of exemplary nature only, since the present invention is equally well applicable in various other contexts.
Fig. 1 shows a schematic illustration of an apparatus 100 according to an embodiment of the present invention.
Apparatus 100 comprises a processor 1 10, which may for instance be a microprocessor, a Digital Signal Processor (DSP), Application Specific Integrated Circuit (ASIC), Field Programmable Gate Array (FPGA) or the like. Processor 1 10 is configured to recognize a user of a medical device based on an at least partial image of the user of the medical device. To this end, processor 1 10 comprises a recognition unit 1 1 1 . Processor 1 10 is further configured to provide information associated with the recognized user for setting up the medical device. To this end, processor 1 10 comprises an information unit 1 12.
Fig. 2 shows a flowchart 200 of a method according to a second embodiment of the present invention. The method steps may be performed by a processor such as processor 100 depicted in Fig. 1 .
A step 201 comprises recognizing a user of a medical device based on an at least partial image of the user of the medical device. In a step 202, information for setting up the medical device, the information being associated with the recognized user of the medical device, is provided. Thereafter, flowchart 200 terminates.
Apparatus 100 depicted in Fig. 1 and the method depicted in flowchart 200 shown in Fig. 2 enable recognizing the user of the medical device based on an at least partial image of the user and providing information associated with the recognized user for setting up the medical device. Wrongly using information that is in fact associated with another user for setting up the medical device is therefore prevented. Thus, adverse
consequences for a patient's health that may arise from a wrongly configured medical device may not occur. A patient not being able to input identification data, e.g. due to a visual impairment or any other medical condition, may still be reliably identified. At the same time, setting up the medical device manually for each user, which is often error- prone and time-consuming, may not be necessary when using apparatus 100 or the method illustrated in Fig. 2.
Fig. 3a shows a schematic illustration of an insulin dose calculator or blood glucose monitor 300 according to a third embodiment of the present invention.
The insulin dose calculator 300 comprises a microprocessor 310. Microprocessor 310 executes program code (e.g. software of firmware) stored on a program memory 320, and uses a main memory 330, for instance to store intermediate results. Program memory 320 may for instance be a Read-Only Memory (ROM), and main memory 330 may for instance be a Random Access Memory (RAM). Microprocessor 310 interacts with a camera 340 comprising an object lens 341 and an optical sensor 342, for example a charged-coupled device (CCD) sensor, a
complementary metal-oxide-semiconductor (CMOS) sensor, and/or the like. A liquid crystal display (LCD) 350 is controlled by microprocessor 310. CCD sensor 342 is configured to acquire an at least partial image of the user of insulin dose calculator 300 via the object lens 341 when the user faces a viewing area of LCD 350. According to the embodiment presently described, camera 340 may be embodied similar to a camera installed in a mobile phone, a web-cam, and/or the like.
Microprocessor 310 also interacts with a blood glucose meter 360, which is configured to receive a blood sample (e.g. on a carrier such as a test-strip) of a user of insulin dose calculator 300 and to determine a blood glucose level therefrom, which then is provided to microprocessor 310 for further processing. Insulin dose calculator 300 may receive input information and/or commands, for instance from a user via a user interface 370. Furthermore, insulin dose calculator 300 comprises a storage memory 380 which is in the present case embodied as a flash memory. Microprocessor 310 is configured to access storage memory 380 for writing data to storage memory 380 or reading data from storage memory 380. A reference database 381 and a set-up database 382 are stored on storage memory 380.
In the switched-on state of insulin dose calculator 300, microprocessor 310 executes the instructions of the program code stored on program memory 320, therein using main memory 330. The instructions cause microprocessor 310 to initiate camera 340 to acquire an image and to analyze the image information consequently provided by CCD sensor 342. This analysis step involves performing face detection on the provided image information. To this end, ellipses are searched for using Hough transform.
According to the instructions executed on microprocessor 310, if no face is detected camera 340 is controlled by microprocessor 310 to acquire another image after a waiting period of few milliseconds up to several seconds, and face detection is once again performed. This process is repeated until a face has been detected in the image information provided by CCD sensor 342. The instructions executed on microprocessor 310 then cause microprocessor 310 to derive recognition information such as the distance between the eyes of the detected face of the user and the shape of the nose and lips of the detected face of the user of insulin dose calculator 300.
Subsequently, microprocessor 310 reads reference data sets from reference database 381 stored on storage memory 380. The reference data sets each comprise reference recognition information that has been previously derived from an at least partial image of the face of a certain user of insulin dose calculator 300. Each reference data set is tied to a user identifier. In the present embodiment, the user identifier comprises the respective user's name and date of birth as well as a consecutive number assigned to the user by microprocessor 310. For the reference recognition information of each of the reference data sets stored in reference database 381 , microprocessor 310 calculates a similarity metric, i.e. in the present case a metric characterizing the similarity of the reference recognition
information of the respective reference data set and the recognition information derived from the image information provided by CCD sensor 342. Microprocessor 310 selects the reference data set for which the similarity metric assumes the highest value. If this value is lower than a predefined threshold, user recognition is considered to have failed. In consequence, the instructions executed on microprocessor 310 cause
microprocessor 310 to control LCD 350 to prompt the user to input his name and date of birth via user interface 370. A new reference data set is then created and stored in reference database 381 . If the value of the similarity metric is above the predefined threshold, user recognition is considered to have been successful. Microprocessor 310 controls LCD 350 to display the name of the recognized user. Optionally, the user may be required to confirm via user interface 370 that he has been correctly identified.
Face recognition based user recognition exploits the fact that the face of a user of insulin dose calculator 300 is generally not covered by clothing, thus allowing for reliable user recognition. In an alternative embodiment, user recognition employs recognition of the retina of a user, recognition of a fingerprint of a user, and/or recognition of any other visually unique feature of a user.
According to the instructions executed on microprocessor 310, microprocessor 310 searches set-up database 382 for information associated with the consecutive number assigned to the recognized user. In the present example the information stored for the recognized user comprises the recognized user's weight, age and gender, the type of insulin the recognized user's physician has recommended for said user and information acquired related to the last use of insulin dose calculator 300 by the recognized user, such as the time of the last use, the insulin dose recommended to the recognized user at the last time of use and the recognized user's blood glucose level at the last time of use. Microprocessor 310 then provides the values of these parameters, i.e. the information retrieved from set-up database 382, and the current blood glucose level metered by blood glucose meter 360 to the program executed on microprocessor 310. Users may consider it convenient that insulin dose calculator 300 also allows for performing a necessary blood glucose metering step so that a separate blood glucose meter is not needed. The program executed on microprocessor 310 is set up according to the information associated with the recognized user and provided by microprocessor 310. The program then determines the dose of insulin the recognized user should inject and the point in time at which this should be done according to an insulin titration algorithm. These parameters are presented to the recognized user on LCD 350 together with the type of insulin. The type of insulin may be programmed into set-up database 382 of storage memory 380 for the user, for example by the user's physician. In other words, insulin dose calculator 300 determines data for the recognized user based on information related to the recognized user, the determined data in this case being which dose of insulin the recognized user requires at which point in time. Insulin dose calculator 300 is thus configured to determine data for a patient, i.e. the recognized user. The information provided by microprocessor 310, comprise user related information relevant to insulin dose calculator 300 for determining the data for the recognized user.
A group assignment parameter is associated with each user identifier existing in set-up database 382. The group assignment parameter may assume two values. It may either indicate that the respective user is a healthcare practitioner or it may indicate that the respective user is a patient. According to the program instructions executed on microprocessor 310, microprocessor 310 assigns the recognized user to the user groups indicated by the group assignment parameter. Information is associated with each of the two user groups. Microprocessor 310 accesses set-up database 382 stored on storage memory 380 to retrieve the information associated with the user group the recognized user is assigned to. Said information is thus also associated with the recognized user. For each user group, the information associated with the respective user group is only stored once in set-up database 382. Thereby the required storage capacity is reduced compared to, for instance, storing the group-specific information separately for each user belonging to the respective user group. In the present example, the information associated with the at least one user group the recognized user is assigned to comprises user authorization information.
If the recognized user is assigned to the healthcare practitioner user group, the recognized user may, according to the user authorization information, determine properties of the insulin titration algorithm used for a certain patient for whom a reference data set is stored in reference database 381 . A healthcare practitioner may also determine and store in set-up database 382 the type of insulin that should be recommended to said patient by insulin dose calculator 300. For a patient for whom user recognition is considered to have failed and who has subsequently input a name and date of birth via user interface 370 to allow for a new reference data set being created, a healthcare practitioner may perform the initial determination of the insulin dose and the insulin type. These parameters may then be stored in set-up database 382. Alternatively, if optical user recognition has failed, the user may be identified by a name and date of birth after entry via user interface 370. If the user is recognized in this way, no new reference data set will be created.
According to the user authorization information, determining and/or modifying the insulin titration algorithm and the recommended type of insulin may not be done by a user assigned to the patient user group. Thus, a patient may not determine these parameters for herself/himself.
If the recognized user is assigned to the patient user group, the blood glucose metering function of blood glucose meter 360 is made available. A healthcare practitioner does not need to use blood glucose meter 360. The blood glucose metering function thereof is therefore not made available to a recognized user assigned to the healthcare practitioner user group.
Fig. 3b shows a schematic illustration of an exterior view of insulin dose calculator 300 of Fig. 3a. The components depicted in Fig. 3a are arranged in a housing 390. A blood sample carrier embodied as a disposable test-strip 395 is inserted in blood glucose meter 360 through a slot provided in housing 390. User interface 370 comprises two keys 371 and 372.
Fig. 3c shows a schematic illustration of a lateral exterior view of insulin dose calculator 300. When facing a viewing area of LCD 350, an at least partial image of the face of a user U may be capture by object lens 341 of camera 340 for user recognition. For a diabetic, the current blood glucose level may depend on the level of physical activity, consumed food, previously administered doses of insulin, and parameters such as the weight of the patient, the insulin dose, type and administration time schedule. A required insulin dose, insulin type and administration time schedule thus also varies from patient to patient. An insulin dose calculator allows determining a recommended insulin dose, insulin type and insulin injection time schedule for a patient. In some cases, two or more people in a single household may require treatment for diabetes, for example two or more members of the same family. It may be desirable that they share an insulin dose calculator such as insulin dose calculator 300, for example for
convenience or in order to reduce healthcare cost. In nursing homes or hospitals an insulin dose calculator may be used for even more than two persons. With insulin dose, type and administration time schedule varying from patient to patient, it is important that the insulin titration algorithm of a shared insulin dose calculator is provided with the correct settings for the respective patient. A wrong recommendation of an insulin dose, insulin type and insulin injection time schedule may have adverse consequence for a patient following said recommendation.
According to the embodiment presently discussed, user recognition by means of face recognition and providing information for setting up insulin dose calculator 300
associated with the recognized user is enabled. It is thereby made sure that a suitable insulin dose, insulin type and insulin injection time schedule is recommended to the user of insulin dose calculator 300. With user recognition being based on face recognition, a patient not being able to input identification data, e.g. due to a visual impairment or any other medical condition, may still be reliably identified. If a healthcare practitioner wants to set-up insulin dose calculator 300 for a patient, this may also be achieved without the healthcare practitioner having to input patient identification data and without the healthcare practitioner having to set-up insulin dose calculator 300 manually.
Fig. 4 shows a flowchart 400 of a method according to a fourth embodiment of the present invention. The method steps may for instance be performed by insulin dose calculator 300 depicted in Fig. 3a, Fig. 3b and Fig. 3c. A step 401 comprises acquiring an image of the face of a user of an insulin dose calculator. In a step 402, recognition information is derived from the acquired image. The derived recognition information is compared to reference recognition information of reference data sets stored in a reference database in a step 403. Therein, for the reference recognition information in each of the reference data sets the value of a similarity metric is calculated. Subsequently, in a step 404, the largest similarity value of the similarity metric that has previously been calculated is selected. It is checked in a step 405 whether the selected similarity value is larger than a predefined threshold.
If this is not the case, the user of the insulin dose calculator is prompted to input his name and his date of birth in a step 406. In a step 407, the recognition information derived in step 402 is tied to the name and the date of birth the user has input in step 407 and the recognition information is stored in the reference database together with the name and the date of birth. Thereafter, flowchart 400 terminates. If it is found in step 405 that the selected similarity value is larger than the predefined threshold in step 405, user recognition is considered to have been successful. In order to retrieve information associated with the recognized user, a user identifier associated with the reference data set comprising the reference recognition information for which the selected largest similarity value has been calculated in step 404 is read from the reference database in a step 408. Said identifier is then used to retrieve information associated with the identifier stored in a set-up database. A group assignment parameter is associated with each user identifier existing in the setup database. This group assignment parameter may assume two values. It may either indicate that the respective user is a healthcare practitioner or it may indicate that the respective user is a patient. In a step 409 the recognized user is assigned to the user group indicated by the group assignment parameter. With each of the two user groups, user authorization information is associated. The authorization information is retrieved in a step 410 from the set-up database.
Subsequently, in a step 41 1 , the retrieved authorization information and the user- specific information retrieved in step 408 is provided to a software program executed on the insulin dose calculator.
If the recognized user has been assigned to the healthcare practitioner user group in step 409, the insulin dose calculator is set-up according to the retrieved authorization information in a step 412 so that the recognized user may determine properties of the insulin titration algorithm used for a certain patient for whom a reference data set is stored in the reference database. The healthcare practitioner may determine the type of insulin said patient should use. These parameters may then be stored in the set-up database together with the identifier of said user. For a patient for whom user
recognition is considered to have failed and who has subsequently input his name and date of birth in step 407, a healthcare practitioner may perform the initial determination of the insulin dose and the insulin type. These parameters may then also be stored in the set-up database. Determining the insulin titration algorithm and the recommended type of insulin may not be done by a user assigned to the patient user group.
If the recognized user is assigned to the patient user group in step 409, the insulin dose calculator is set-up according to the retrieved authorization information in step 412 so that a blood glucose metering function of a blood glucose meter forming part of the insulin dose calculator is made available. The blood glucose metering function thereof is however not made available to a recognized user assigned to the healthcare
practitioner user group in step 409. For a recognized user assigned to the patient user group, step 412 also comprises setting up the software executed by the insulin dose calculator according to the infornnation retrieved in step 408. Said infornnation comprises the recognized user's weight, age and gender, the type of insulin the recognized user's physician has recommended for said user and information acquired during the last use of the insulin dose calculator by the recognized user, such as the time of the last use, the insulin dose recommended to the recognized user at the last time of use and the recognized user's blood glucose level at the last time of use. Based on this information and a measured current blood glucose level the insulin dose calculator may then determine the dose of insulin the recognized user should inject and the point in time at which this should be done according to an insulin titration algorithm. These parameters may be presented to the recognized user together with the type of insulin recommended by the recognized user's physician for the recognized user.
Fig. 5a shows a schematic illustration of an insulin injector 500 according to a fifth embodiment of the present invention in the presence of a first person U1 .
Insulin injector 500 is an insulin injection pen. It comprises a housing 510 and contains an insulin container 520, to which a needle 530 can be affixed. The needle 530 is protected by a needle cap 540. Insulin injector 500 further comprises a small LCD 550 and a CCD sensor camera 560. Insulin injector 500 also comprises a processor (not shown) controlling the camera and LCD 550.
An insulin dose to be injected with insulin injector 500 can be selected by turning a dosage knob 570. The processor controls LCD 550 to display the selected dose in a dosage display area 551 . According to the embodiment presently discussed, the selected dose is displayed in multiples of so-called International Units (IU) wherein one IU is the biological equivalent of about 45.5 g pure crystalline insulin (1/22 mg exactly). An example of a selected dose displayed in dosage display area 551 may for instance be 30 lUs, as shown in Fig. 5a. Insulin injector 500 further comprises an injection button 580. When needle 530 is stuck into a skin portion of a patient, and injection button 580 is pushed, the insulin dose displayed in dosage display area 551 will be injected into the patient's body. The processor forming part of insulin injector 500 is configured to recognize a user of insulin injector 500 based on an at least partial image of the user's face acquired by camera 560. The processor is further configured to provide information associated with the recognized user for setting up insulin injector 500 according to the information.
The provided information comprises user authorization information. According to the embodiment, insulin injector 500 belongs to user U1 . User U1 is the only patient allowed to use insulin injector 500. If the processor recognizes, by means of face recognition, that the user facing object lens 510 is user U1 , the authorization information associated with user U1 is retrieved and provided to a software program executed on the processor. The software program is set-up accordingly.
As a consequence thereof, the software program may cause the processor to control LCD 550 to display a check mark in a authorization display area 552, thus indicating to user U1 that he is allowed to use insulin injector 500, and to control an actuator to unlock injection button 580. To this end, a second condition has to be met: The provided information associated with the recognized user comprises a time schedule according to which user U1 is to inject insulin. The time schedule has been predefined by the physician of user U1 . Setting up insulin injector 500 according to the predefined schedule causes the software program executed on the processor to control LCD 550 to display a check mark in authorization display area 552 and to unlock injection button 580, only if the predefined timing schedule requires user U1 to inject insulin at the current point in time. If user U1 is recognized at a point in time at which he is not required to inject insulin according to the time schedule, a cross may be displayed in authorization display area 552 thus indicating to user U1 that he is not allowed to use insulin injector 500 at that point in time. An acoustic warning may be issued at the same time, for instance by means of a speaker (not shown) integrated into insulin injector 500. In order to prevent user U1 from injecting insulin, injection button 580 may remain in a mechanically locked state. The time schedule is thus information relevant for
administering insulin to the recognized user U1 . Fig. 5b shows a schematic illustration of insulin injector 500 of Fig. 5a in the presence of a second person U2. As insulin injector 500 belongs to user U1 , user U2, who may also be diagnosed with diabetes but may require a different treatment, for example a different type of insulin according to a different time schedule, is not allowed to use it. If user U2 is recognized as user U2 by the processor of insulin injector 500 or if user U2 is not recognized at all, e.g. due to no reference recognition information being available for user U2, a cross is displayed in authorization display area 552 of LCD 550 as shown in Fig. 5b. User U2 is thus informed that he may not use insulin injector 500. Injection button 580 may remain in a locked state. User U2 is thus prevented from accidentally using insulin injector 500. Accidentally using insulin injector 500 may have severe medical consequences for user U2 due to the injection of the wrong type of insulin.
Insulin injector 500 may comprise an insulin dose calculator such as insulin dose calculator 300 depicted in Fig. 3a, Fig. 3b and Fig. 3c. Microprocessor 310 of insulin dose calculator may then also serve for performing the functions of the above described processor of insulin injector 500. Naturally, only one camera, e.g. camera 340 of insulin dose calculator 300 will be needed. Insulin dose calculator 300 may automatically cause selection of a suitable insulin dose, for instance via a suitable actuator, once user U1 has been recognized. Insulin dose calculator 300 and insulin injector 500 may or may not be arranged in a common housing.
Fig. 6 shows a flowchart 600 of a method according to a sixth embodiment of the present invention. The method steps may for instance be performed by insulin injector 500 depicted in Fig. 5a and Fig. 5b.
In a step 601 , the user of an insulin injector is recognized based on an at least partial image of the face of the user of the insulin injector. Subsequently, in a step 602, it is checked, whether the recognized user is a user U1 to whom the insulin injector belongs. If the user of the insulin injector is recognized as another user than user U1 or if user recognition is considered to have failed, information is provided to a software program executed on a processor of the insulin injector in a step 602. Therein, the software program is also set-up accordingly. Consequently, the software program causes a processor of the insulin injector to control a display of the insulin injector to display a cross in a step 603, thus indicating to the user that he/she is not allowed to use the insulin injector. An injection button of the insulin injector may remain in a mechanically locked state. Thereafter flowchart 600 terminates.
If the user of the insulin injector is recognized as user U1 , authorization information and a predefined time schedule is provided to the software program executed on the processor of the insulin injector in a step 604. According to the authorization information, user U1 is generally allowed to use the insulin injector. However, in a step 605 it is checked whether the current time is an insulin injection time according to the predefined time schedule. If this not the case, the software program is set up in a step 606 to cause the processor of the insulin injector to control the display of the insulin injector to display a cross, thus indicating to the user that he/she is not allowed to use the insulin injector. The injection button of the insulin injector may remain in a mechanically locked state. Thereafter flowchart 600 terminates. If the current time is an insulin injection time according to the predefined time schedule, the software program is set-up in a step 607 to cause the processor of the insulin injector to control the display of the insulin injector to display a check mark and to control an actuator of the insulin injector to unlock the injection button, thus indicating to the user that he is currently allowed to use the insulin injector. Thereafter flowchart 600 terminates.
The software may provide an option to override the lock of the insulin injector in step 603 or step 606, for example in emergency situations where it is necessary to deviate from the recommended insulin dose or predefined time schedule. Such an emergency situation may include hyperglycemia in this or another patient.
Fig. 7 is a schematic illustration of a tangible storage medium 700 (a computer program product) that comprises a computer program 710 with program code 720 according to a seventh embodiment of the present invention. This program code may for instance be executed by a processor such as the processor 100 in Fig. 1 , the microprocessor 310 contained in insulin dose calculator 300 of Fig. 3a, 3b and 3c or in the processor of insulin injector 500 depicted in Fig. 5a and Fig. 5b. For instance, storage medium 700 may represent program memory 320 of insulin dose calculator 300 of Fig. 3a, 3b and 3c. Storage medium 700 may be a fixed memory, or a removable memory, such as for instance a memory stick or card.
The term ..medicament", as used herein, means a pharmaceutical formulation
containing at least one pharmaceutically active compound, wherein in one embodiment the pharmaceutically active compound has a molecular weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, a DNA, a RNA, a antibody, an enzyme, an antibody, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound, wherein in a further embodiment the pharmaceutically active compound is useful for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever,
atherosclerosis and/or rheumatoid arthritis, wherein in a further embodiment the pharmaceutically active compound comprises at least one peptide for the treatment and/or prophylaxis of diabetes mellitus or
complications associated with diabetes mellitus such as diabetic retinopathy, wherein in a further embodiment the pharmaceutically active compound comprises at least one human insulin or a human insulin analogue or derivative, glucagon-like peptide (GLP-1 ) or an analogue or derivative thereof, or exedin-3 or exedin-4 or an analogue or derivative of exedin-3 or exedin-4. Insulin analogues are for example Gly(A21 ), Arg(B31 ), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin;
Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.
Insulin derivates are for example B29-N-myristoyl-des(B30) human insulin; B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl- LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N- palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-Y-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; Β29-Ν-(ω- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-( -carboxyhepta_idecanoyl) human insulin.
Exendin-4 for example means Exendin-4(1 -39), a peptide of the sequence H His-Gly- Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe- lle-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.
Exendin-4 derivatives are for example selected from the following list of compounds:
H-(Lys)4-des Pro36, des Pro37 Exendin-4(1 -39)-NH2,
H-(Lys)5-des Pro36, des Pro37 Exendin-4(1 -39)-NH2,
des Pro36 [Asp28] Exendin-4(1 -39),
des Pro36 [lsoAsp28] Exendin-4(1 -39),
des Pro36 [Met(O)14, Asp28] Exendin-4(1 -39),
des Pro36 [Met(O)14, lsoAsp28] Exendin-4(1 -39),
des Pro36 [Trp(O2)25, Asp28] Exendin-4(1 -39),
des Pro36 [Trp(O2)25, lsoAsp28] Exendin-4(1 -39),
des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1 -39),
des Pro36 [Met(O)14 Trp(O2)25, lsoAsp28] Exendin-4(1 -39); or des Pro36 [Asp28] Exendin-4(1 -39),
des Pro36 [lsoAsp28] Exendin-4(1 -39),
des Pro36 [Met(O)14, Asp28] Exendin-4(1 -39), des Pro36 [Met(O)14, lsoAsp28] Exendin-4(1 -39),
des Pro36 [Trp(O2)25, Asp28] Exendin-4(1 -39),
des Pro36 [Trp(O2)25, lsoAsp28] Exendin-4(1 -39),
des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1 -39),
des Pro36 [Met(O)14 Trp(O2)25, lsoAsp28] Exendin-4(1 -39),
wherein the group -Lys6-NH2 may be bound to the C-terminus of the Exendin-4 derivative; or an Exendin-4 derivative of the sequence
H-(Lys)6-des Pro36 [Asp28] Exendin-4(1 -39)-Lys6-NH2,
des Asp28 Pro36, Pro37, Pro38Exendin-4(1 -39)-NH2,
H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1 -39)-NH2,
H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-NH2,
des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-(Lys)6-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-(Lys)6-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-(Lys)6-NH2,
H-(Lys)6-des Pro36 [Trp(O2)25, Asp28] Exendin-4(1 -39)-Lys6-NH2,
H-des Asp28 Pro36, Pro37, Pro38 [Trp(O2)25] Exendin-4(1 -39)-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1 -39)-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1 -39)-NH2, des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-(Lys)6-des Pro36 [Met(O)14, Asp28] Exendin-4(1 -39)-Lys6-NH2,
des Met(O)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1 -39)-NH2,
H-(Lys)6-desPro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1 -39)-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1 -39)-NH2, des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1 -39)-Lys6-NH2,
H-des Asp28 Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25] Exendin-4(1 -39)-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1 -39)-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1 -39)- NH2,
des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(S1 -39)- (Lys)6-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1 -39)- (Lys)6-NH2; or a pharmaceutically acceptable salt or solvate of any one of the afore-mentioned Exedin-4 derivative.
Hormones are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin,
Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.
A polysaccharide is for example a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra low molecular weight heparin or a derivative thereof, or a sulphated, e.g. a poly-sulphated form of the above-mentioned
polysaccharides, and/or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium.
Pharmaceutically acceptable salts are for example acid addition salts and basic salts. Acid addition salts are e.g. HCI or HBr salts. Basic salts are e.g. salts having a cation selected from alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion
N+(R1 )(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1 C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10- heteroaryl group. Further examples of pharmaceutically acceptable salts are described in "Remington's Pharmaceutical Sciences" 17. ed. Alfonso R. Gennaro (Ed.), Mark Publishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia of Pharmaceutical Technology. Pharmaceutically acceptable solvates are for example hydrates.
The invention has been described above by means of embodiments, which shall be understood to be non-limiting examples only. In particular, it should be noted that there are alternative ways and variations which are obvious to a skilled person in the art and can be implemented without deviating from the scope and spirit of the appended claims.
It should also be understood that the sequence of method steps in the flowcharts presented above is not mandatory. Alternative sequences may be possible. All functional blocks of apparatuses shall also be understood as a disclosure of an according method step, and similarly, each method step shall be considered as a disclosure of an according functional unit of an apparatus. It is well understood that the method steps and functional components can be implemented in various ways either in hardware only, or in software only, or in a combination of hard- and software.

Claims

Claims
An apparatus (300; 500) comprising:
a processor (310) configured to recognize a user of a medical device (300; 500) based on an at least partial image of the user (U; U1 , U2) of the medical device (300; 500), the processor (310) being further configured to provide information associated with the recognized user (U; U1 , U2) for setting up the medical device (300; 500), wherein the medical device (300; 500) is configured to determine data for the recognized user, wherein the recognized user is a patient, characterized in that the information associated with the recognized user (U; U1 , U2) comprises user related information relevant for determining the data for the recognized user (U; U1 , U2), wherein the data comprise at least one of:
a dose of insulin to be administered to the recognized user (U; U1 , U2);
a type of insulin to be administered to the recognized user (U; U1 , U2); and a time schedule according to which insulin is to be administered to the
recognized user (U; U1 , U2).
The apparatus (300; 500) according to claim 1 , further comprising an image sensor (342) configured to acquire the at least partial image of the user (U; U1 , U2) of the medical device (300; 500).
The apparatus (300; 500) according to claim 1 or 2, further comprising the medical device (300; 500).
The apparatus (300; 500) according to any of the claims 1 -3, wherein the processor (1 10; 310) is configured to recognize the user (U; U1 , U2) of the medical device by means of face recognition.
The apparatus (300; 500) according to any of the claims 1 -4, wherein the processor (310) is further configured to assign the recognized user (U; U1 , U2) to at least one user group of at least two user groups and wherein the information associated with the recognized user (U; U1 , U2) comprises information associated with the at least one user group the recognized user (U; U1 , U2) is assigned to.
The apparatus (300; 500) according to claim 5, wherein the information
associated with the at least one user group the recognized user (U; U1 , U2) is assigned to comprises user authorization information.
The apparatus (300; 500) according to any of the claims 1 -6, wherein the medical device (300; 500) is a device (500) configured to administer a medicament to a patient and wherein the information associated with the recognized user (U; U1 , U2) comprises information relevant for administering the medicament to the recognized user (U; U1 , U2).
The apparatus (500) according to claim 7, wherein the information associated with the recognized user (U; U1 , U2) comprises at least one of
a dose of a medicament to be administered to the recognized user (U; U1 , U2), a type of a medicament to be administered to the recognized user (U; U1 , U2) and
a time schedule according to which a medicament is to be administered to the recognized user (U; U1 , U2).
9. The apparatus (500) according to claim 7 or 8, wherein the medical device is an insulin injector (500).
10. The apparatus (300; 500) according to any of the claims 1 -9, wherein the medical device (300; 500) comprises a blood glucose meter (360).
1 1 A method (400), comprising
recognizing a user (U; U1 ; U2) of a medical device (300; 500) based on an at least partial image of the user (U; U1 ; U2) of the medical device (300; 500), providing infornnation for setting up the medical device (300; 500), the information being associated with the recognized user (U; U1 ; U2) of the medical device (300; 500),
wherein the medical device (300; 500) is configured to determine data for the recognized user, wherein the recognized user is a patient,
characterized in that the information associated with the recognized user (U; U1 , U2) comprises user related information relevant for determining the data for the recognized user (U; U1 , U2), wherein the data comprise at least one of:
a dose of insulin to be administered to the recognized user (U; U1 , U2);
a type of insulin to be administered to the recognized user (U; U1 , U2); and a time schedule according to which insulin is to be administered to the
recognized user (U; U1 , U2).
12. A computer program (710), comprising instructions operable to cause a
processor (310) to perform the method (400) of claim 1 1 when said computer program (710) is executed on said processor (310).
PCT/EP2011/054391 2010-03-24 2011-03-23 Device and method for providing information for setting up a medical device WO2011117270A1 (en)

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EP10157490 2010-03-24
EP10157490.3 2010-03-24

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