EP3659152A1 - Dispositif médical pour mémoriser et évaluer des données cliniques - Google Patents

Dispositif médical pour mémoriser et évaluer des données cliniques

Info

Publication number
EP3659152A1
EP3659152A1 EP18755697.2A EP18755697A EP3659152A1 EP 3659152 A1 EP3659152 A1 EP 3659152A1 EP 18755697 A EP18755697 A EP 18755697A EP 3659152 A1 EP3659152 A1 EP 3659152A1
Authority
EP
European Patent Office
Prior art keywords
data
medical
patient
medical device
hardware
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
EP18755697.2A
Other languages
German (de)
English (en)
Inventor
Peter WESTERHOFF
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
WOM World of Medicine GmbH
Original Assignee
WOM World of Medicine 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
Priority claimed from DE102017007099.7A external-priority patent/DE102017007099A1/de
Application filed by WOM World of Medicine GmbH filed Critical WOM World of Medicine GmbH
Publication of EP3659152A1 publication Critical patent/EP3659152A1/fr
Pending legal-status Critical Current

Links

Classifications

    • 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
    • G16H20/40—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
    • 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
    • G16H40/67—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 remote operation
    • 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
    • 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
    • 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
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/70—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients
    • 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
    • G16H70/00—ICT specially adapted for the handling or processing of medical references
    • G16H70/20—ICT specially adapted for the handling or processing of medical references relating to practices or guidelines

Definitions

  • networking means the comprehensive use of information in the operating room of all available and relevant data
  • Medical device means any energy-powered or non-powered device used for diagnostic or therapeutic interaction with the human or animal body
  • Disposables are also explicitly designated as medical devices.
  • CONFIRMATION COPY Medical devices in-depth knowledge, some of which are taught in training courses. All these described ways of a standardized application of medical devices for a diagnostic or therapeutic procedure to good clinical results in the patient are tedious and associated with great effort.
  • EP1995679 describes an apparatus and a method for networking and central operation and data transmission for documentation purposes and / or control or parameter adjustment of at least one device that is used during a medical procedure.
  • Central is one
  • Paragraph [0030] describes access to the central database via local area network or Internet.
  • this data base should contain "expert knowledge” and / or predetermined device parameters independent of the respective physician, which will be extended to propose the device combination mentioned in paragraph [0013] for the respective medical procedure and the physician, ie a type Assistance System for Instrumentation Paragraph [0023] describes that predetermined device configurations and parameters may be part of the database.
  • Paragraph [0016] describes that device parameters or device actions are triggered by a signal automatically generated by a sensor. However, there is no technical teaching, except that a device presetting is automatically adopted - due to which sensors and what cause this is not executed. A regulation of
  • Paragraph [0028] describes that data of the patient (age, height, weight, existing or already recognized diseases, anatomical
  • Paragraph [0029] describes their provision in the database and various patient-dependent data sets or a formula for calculating patient-dependent parameters
  • EP 2763064 A2 describes an insulin pump with a configurator for setting operating parameters of the insulin pump.
  • the invention therefore relates to a medical device for
  • Storage of medical data comprising at least one computing unit, consisting of a selection and correlation module, a feed module with self-learning sub-module, at least one memory unit which stores measurement data and / or patient data obtained via the interface and which optionally contains at least one data record permanently as a fallback level, at least one interface to at least one other
  • the interface transmits measurement data and / or patient data to the memory unit, at least one interface for reading patient information to at least one hospital information system (patient file) and / or an image recognition system for reading
  • Patient information at least one processing device in which in the
  • Storage unit existing Apriori information processed with the information obtained via the interface in such a way to provide calculated according to a predetermined criterion operating parameters via an interface of another medical device.
  • a derivation of device configurations or device settings can take place, as well as indications for the guideline-compatible treatment from the intraoperative data the medical device will be transmitted.
  • Sources of information in the operational environment such as the hospital information system (HIS) or the anesthesia system, as well as the
  • Interfaces can be realized electronically or otherwise, eg by image recognition and evaluation of a medical device with a camera of data on forms or screens.
  • the field of application of the expert system may include further functional units in the operating room.
  • the expert system is a device for collecting data from
  • Medical devices and pre- and postoperative patient data the patient data with process data determined during the procedure as well as clinical data
  • Process data and process information with the best clinical results are bundled and weighted consecutively with new data input, the process data with the best clinical result of a class determined as optimum and the determined optimum returned to the medical device as a presetting.
  • the re-transmission will include clinical guidelines and clinical experience with regard to the data groups and
  • the medical device also has a data fallback level in case of failed data transmission.
  • Automated collection and feedback of device configurations is done through a centralized data collection, data analysis, and data collection
  • Data storage device a so-called expert system that is accessible via a network from the medical device.
  • This expert system consists of a selection and correlation module, a rules and expertise feed-in module with a self-learning sub-module and a data-retention module that maps, classifies, stores and controls content access.
  • the contents are data sets consisting of anonymized patient data, anamnesis data, procedure information, information on medical devices used, intraoperative vital data and device data or device parameters, postoperative
  • a server may be reachable via the Internet and only parameter maps to the device, which the Source information (device parameters, vital data, patient data) returns.
  • the inventive solution for the expert system includes at least one
  • solution according to the invention may include
  • the automated information processing is analyzed and classified
  • Patient and device data passes it to the database for further processing and logging.
  • the classification procedure corresponds to the established procedures and a suitable classifier structure is created for each area of application. Training and validation of the classifier is done using data from the clinical environment.
  • the database uses data from established medical
  • a pre-and intra-operative phase and anonymized analysis device associated with the database combines data sets of the expert system with past intervention records and newly collected operation and clinical data
  • Information from the intraoperative phase is collected, anonymized and analyzed to build an expert system in the postoperative period.
  • the postoperative phase among others:
  • Process information is collected, analyzed and provided to other networked medical subsystems.
  • Data classes e.g., patient type, surgery type
  • data classes e.g., patient type, surgery type
  • Groupings of records are created and associated patient and anamnesis data are analyzed. From the data analysis will be
  • Such a predetermined rule could be to give preference to the lowest possible target pressure value for the body cavity as a returned device parameter.
  • Another rule might be age-dependent Target pressure value, which is fixed.
  • the records are collected continuously. Returned device settings can be changed by the surgical team. In addition to the device setting values that react directly to vital data, presets can be used to determine device presets or controller behavior.
  • Insufflators and pumps in minimally invasive surgery in the medical device have been modified directly or indirectly by data input, which ensures an improved device function which improves vision in the patient
  • Anamnesis data is collected and logged before each surgery. The use of this Apriori data is so far only manually by the clinical
  • Device setting can be used.
  • the device configuration should be automated in the form of controller parameters and setpoint specification.
  • the solution according to the invention also includes a holistic
  • an automated anamnesis evaluation which includes a fusion of current patient data with an expert system.
  • the device systems used during the procedure are intended by means of
  • the transmission of the data can be automated without intervention of a
  • the feedback of device settings to the medical device may be via a previously established secure connection or as an addressed and
  • the receipt of the data packet can be specified by the receiving and target
  • Certain procedures that are based on the medical process or for other reasons require a specific response of the medical device can be formulated as a rule in the evaluation of the expert system deposited. This may include, for example, a reduction of
  • Warning after a certain pressure-time combination (where longer time equates to low pressure with short time and high pressure and a maximum pressure-time limit should not be exceeded) or the gradual reduction of the set pressure as the procedure progresses a set increase above a defined threshold.
  • Further rules are conceivable and can be applied by the server via the device parameters sent by the medical device and can be answered with device settings coordinated with the incoming data.
  • the postoperative assessments of the success of the treatment also become patient-specific and case-specific
  • the assignment can be made anonymized via order features that are generated previously (eg a case number of the hospital) or over time (date) and patient data (name, date of birth and / or health insurance number) or via specially generated assignment characteristics ( random token).
  • Expert system according to the invention a return of such data done that ensure safe operation of the medical device.
  • Set point recommendations and / or controller presettings derived from the data analysis or a selection for control algorithms of the medical devices flow into an assistance system for supporting the clinical staff.
  • the assistance system assists the surgeon by linking a constantly expanding expert system with records of individual patient data and technical metrics to achieve optimal clinical outcomes.
  • the assistance systems can also be used for certain
  • Further assistance functions can be in a trend analysis of values that generates a warning and thus changes the further progress compared to the determined trend due to reaction of the OR team or changed device settings.
  • Another aspect of the expert system connection is a collection of data provided for the documentation of the individual surgical procedure to the hospital or evaluated as quality assurance, used anonymously for medical studies, or used anonymously as a basis for the development of medical device controls.
  • Pre-sorting based on clinical expertise is intended to divide the anamnestic data into data classes (e.g., in the simplest case, patient type, type of surgery, medication, etc.).
  • patient therapy is significantly improved by reducing bleeding and / or unwanted tissue damage from excessive pressure in medical procedures in the MIC
  • Patient and surgery type performed the procedure and achieved the result.
  • the statistical evaluation is carried out on an anonymous or pseudonymised data basis.
  • the information collection, evaluation and information-based process optimization are anonymous and yet patient-specific to realize.
  • methods such as multivariate regression analysis are used, but also other suitable methods. With these procedures becomes a
  • the challenge is to derive causality from correlations. If this does not succeed, there is a risk of deriving incorrect recommendations for action from the experience and knowledge database.
  • the medical device according to the invention consists in a
  • Embodiment of a central computer which can exchange via an interface in the hospital network, for example, a secure network connection with medical devices in the operating room, measurement data from sensors, information about the treated with the medical device patients and operating parameters of the medical devices. These medical devices are also medical devices.
  • This computer is connected to a storage unit, wherein the respective data to be assigned to a treatment case are collected and stored in a structured manner. This data ever
  • treatment cases include both the transmitted technical operating data of the medical device and other transmitted data, e.g. connected by others
  • the device can either be connected directly to the hospital information system, ie the electronic patient record, or via suitable image recognition devices, e.g. medical cameras or scanners or webcams and a downstream image recognition, the patient data capture.
  • suitable image recognition devices e.g. medical cameras or scanners or webcams and a downstream image recognition, the patient data capture.
  • the central computer calculates on the basis of superordinate rules and / or the evaluation of existing data records with a clinical result with the incoming data of the medical device from similar data containing the best possible clinical result, operating parameters and returns them to the medical device.
  • One type of such calculation may be a simple correlation of incoming data with existing data.
  • the central computer groups the incoming data according to specific criteria such as age group, weight, gender and identifies the medical devices used, such as the medical device.
  • Barcode reader or manual input possibly encoded via RFID
  • the communication between the medical device and the medical device can be done on the state of the art corresponding network connections that can be either cable or radio-based. Usually, such sensitive patient data
  • the communication devices can be designed online as a network connection or offline as a data storage between the medical device and be transported physically and can be read and described in each case by devices on medical device and medical device.
  • the communication may include a set point recommendation for the pressure in the body cavity based on patient age (e.g., protective mode for children), patient sex (e.g., abdominal pressure different for men and women), procedure (e.g., pressure settings for particular joints or
  • Medical products are transmitted. This allows, for example, the optimal management of new on the market and not known before the start of the medical device parameters of these new medical devices. Through communication, the optimal operating parameters determined elsewhere can be transmitted and made available to the medical device in the following. Also according to the invention is the
  • medical device are evaluated according to the latest findings and returned to the medical device further operating parameters or for the current operative phase setpoints in terms of optimal, that is, the best possible clinical outcome. These are displayed as a recommendation by the medical device and can be easily adopted.
  • a communication is made possible between the physician evaluating the clinical outcome and the patient with regard to the postoperatively evaluated assessments of the clinical outcome (e.g.
  • the medical device includes a processing device that is correspondingly over-archived to those already described
  • Expert knowledge accepts the data or changes it to other values. These superordinate rules are entered via an input device and can be tested and analyzed via a separate functional environment (sandbox of the prior art), which is separate from the normal operation.
  • the medical device with computer etc. may also be integrated in a medical device. Then the expert system is part of the fluid pump. In a further, preferred embodiment, the medical device is a separate device which is connected via a network with the medical devices located in the operating room.
  • a concrete usage scenario of the medical device when using a fluid pump for expanding body cavities, can proceed as follows:
  • the pump determines all OP-related data in the hospital network: Patient master data (without name, but with case Number) plus anamnesis data relevant to device control.
  • the pump sends the classified data to
  • Exertensystem and receives operating parameters. These are indicated by the pump as suggestions that can be accepted by the doctor.
  • the data obtained in the operating room are sent with an assignment code (identifier) to the expert system and stored there. Possibly.
  • assignment code identifier
  • status data are sent to the expert system and operating parameters (suggestions that can be accepted by the physician) or notes and warnings from the patient
  • Post-mortem information from the hospital is kept in the pump as a list of "open items" and checked in the HIS and sent to the expert system if available (eg the values for assessing the clinical outcome should be collected 4 weeks after the surgery) PLUS 1-day leave of further 4 weeks) will be the
  • Demand devalued provided the pump was turned on in time.
  • Query may e.g. in the tube filling phase, when the pump is busy with the OP setup and does not perform any activities critical to the patient or during breaks in surgery (detection "tube removed", but after "tube removed", the current may suddenly be off as the device degrades Furthermore, the uninterrupted connection to the expert system is not guaranteed and can also be interrupted during the operation
  • This opening can also be done as a VPN connection.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Medical Informatics (AREA)
  • Primary Health Care (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • General Business, Economics & Management (AREA)
  • Business, Economics & Management (AREA)
  • Data Mining & Analysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Databases & Information Systems (AREA)
  • Pathology (AREA)
  • Bioethics (AREA)
  • Medical Treatment And Welfare Office Work (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

L'invention concerne un dispositif médical destiné à mémoriser des données médicales pour la collecte d'informations, l'évaluation d'informations et l'optimisation itérative de processus sur la base d'informations, qui contient une accumulation et une mise à dispositif automatique de connaissances par une collecte automatisée et anonyme de données provenant de composants en réseau de la salle d'opération pour la chirurgie non effractive (MIC), donc par exemple des insufflateurs, des pompes, des caméras, des moniteurs, des instruments thérapeutiques, ainsi que par des évaluations postopératoires du succès du traitement associées à ces données.
EP18755697.2A 2017-07-28 2018-07-10 Dispositif médical pour mémoriser et évaluer des données cliniques Pending EP3659152A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE102017007099.7A DE102017007099A1 (de) 2017-07-28 2017-07-28 Medizintechnische Vorrichtung zur Speicherung und Auswertung klinischer Daten
DE102017012064 2017-12-29
PCT/DE2018/000211 WO2019020137A1 (fr) 2017-07-28 2018-07-10 Dispositif médical pour mémoriser et évaluer des données cliniques

Publications (1)

Publication Number Publication Date
EP3659152A1 true EP3659152A1 (fr) 2020-06-03

Family

ID=63244342

Family Applications (1)

Application Number Title Priority Date Filing Date
EP18755697.2A Pending EP3659152A1 (fr) 2017-07-28 2018-07-10 Dispositif médical pour mémoriser et évaluer des données cliniques

Country Status (5)

Country Link
US (1) US20200168313A1 (fr)
EP (1) EP3659152A1 (fr)
JP (1) JP7179822B2 (fr)
CN (1) CN110959179B (fr)
WO (1) WO2019020137A1 (fr)

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US20220238216A1 (en) * 2021-01-22 2022-07-28 Ethicon Llc Machine learning to improve artificial intelligence algorithm iterations
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Also Published As

Publication number Publication date
WO2019020137A1 (fr) 2019-01-31
US20200168313A1 (en) 2020-05-28
JP2020530148A (ja) 2020-10-15
JP7179822B2 (ja) 2022-11-29
CN110959179A (zh) 2020-04-03
CN110959179B (zh) 2023-11-17

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