EP3659151A1

EP3659151A1 - Apparatus and method for linking and evaluating information in clinical data in a medical device

Info

Publication number: EP3659151A1
Application number: EP18759243.1A
Authority: EP
Inventors: Peter WESTERHOFF; Julia GRUNDMANN; Yves Köth; Matthias Hildebrand; Hans-Joachim CAPPUIS
Original assignee: WOM World of Medicine GmbH
Current assignee: WOM World of Medicine GmbH
Priority date: 2017-07-28
Filing date: 2018-07-10
Publication date: 2020-06-03
Also published as: WO2019020136A1; JP7208217B2; CN110945596B; CN110945596A; US20200168326A1; JP2020529875A

Abstract

The subject matter of the invention relates to a medical engineering apparatus for use in minimally invasive surgery (MIC). Until now, minimally invasive surgery (MIC) as a device solution has stood isolated from the network components of the operating theatre. The specialist medical staff should be assisted with setting devices by an assistance system by way of a better integration of the devices used for MIC (e.g., insufflators, pumps, cameras, monitors) into the overall surgical procedure and by way of a producer-independent, open approach to collecting information, evaluating information and optimizing the process on the basis of information. Much information can already be collected or gathered in the preoperative phase prior to the actual surgical intervention, in order to make said information available for the intraoperative phase. At the same time, a first individualization of the diagnosis or therapy for the respective patient can be undertaken on the basis of these data.

Description

Apparatus and method for information linking and evaluating clinical data in a medical device

Inventive subject matter

The area of application is the use of data from networked devices in minimally invasive, surgical OP, patient data and / or previous experience

Databases for the assistance of the operators in the device adjustment as well as for the current device control on the basis of the data.

The solution according to the invention relates to concepts for device-internal use of comprehensive networking in the clinical environment of surgical interventions

Diagnostics or therapy.

With "networking" the comprehensive information use of all is

Operating room meant existing and relevant data. By "medical device" is meant any energy-powered or non-powered device used for diagnostic or therapeutic interaction with the human or animal body.

State of the art

The state of the art related to the field of minimally invasive surgery (MIC) currently comprises a device system of several individual components. Access for medical devices to the patient's surgical site is through a trocar-optic combination. The trocar is the seal against the body shell with a defined access for instruments and can be tightly closed by valves. The trocar is connected via a hose system with a pumping device. With this pump device or fluid pump is in surgical procedures in body joints or other body cavities (for example, bladder, rectum, uterus, joints, abdominal cavity or other artificially created or natural openings in the human body) flushing medium (liquid or gaseous) on the

Hose connection pumped for expansion in the operation area.

CONFIRMATION COPY If a liquid is used as the rinsing medium, surgical instruments such as a shaver is introduced into the patient via a further access. This is often connected to a drainage, which together with the blood and rinsing liquid

Tissue remnants removed from the patient. For another intervention in the field of MIC is the expansion of the

Abdominal cavity with a gaseous medium requirement. Again, a trocar is used for the access of the instruments, of which at least one is used for the supply of the gaseous medium and often another for the discharge of the gaseous medium. These two functions of entry and exit can also be combined in a single device. The inlet and outlet also takes place via tube systems and is controlled by a pumping device or an insufflator.

Task of device internal regulation of both aforementioned types of

Pumping devices is to build up and maintain a defined pressure in the field of operation while a desired volumetric flow rate can be adjusted. There are a few, purely technical parameters available for the control of the pumping devices. A current challenge is therefore the pressure in the

Adjust the surgical field optimally to the individual patient and to maintain it even under disturbances. The regulation of pumps and insufflators has already reached a high technical level, which can hardly be improved without the integration of further data and influencing parameters via a networked interface.

In general, an obvious solution for using data from the treated patient is manual entry into the control panel of the medical device. This is error prone and time consuming. The procedures in the operating room do not seem to make such an input to the medical devices time-efficient in advance since patients are also treated at short notice in other, similarly equipped operating theaters.

Any time savings can be directly translated into cost savings, which financially relieves the hospital and, ultimately, the healthcare system. Medical devices gain by the implementation of the invention

additional data interfaces in functionality, usability, performance but also security.

The as state of the art in the field of networking of medical technology

Existing approaches concern the communication structures for networking devices, but not the use of the data by the medical devices. The networking activities under OR.Net focused on the development of open interface standards for the communication of

Medical devices with each other. Similar approaches have started in the USA under the heading MD PnP. Within the OR, various devices still operate autonomously today, which is mainly due to the non-uniform interfaces of the various manufacturers of medical devices. These open interfaces provide one

Expandability by underlying definitions

manufacturer-independent and device-open. Different with the

Closed proprietary communication solutions from manufacturers such. Company Stryker: SIDNE - Company Richard Wolf: Core Nova - Company Storz: OR-1 - Company Dräger: Infinity - Company Olympus: Endoalpha - Company Maquet: Tegris - and others, not all

Disclose communication protocols and provided data.

WO 2009/032134 describes a method and apparatus for transporting data from an implanted medical device via a wireless connection to a network to which servers, medical stations and programming stations are connected. This breaks down into several inventions, of which the method in claims 38-41, whereby a mutual authentication of a portable patient communication device and a remote server and after successful

Authentication of the following data exchange are disclosed. The implementation of such functionality is not part of the solution according to the invention and can be made possible in other ways according to the prior art without restricting the inventive solution.

WO 2014/040175 discloses a server-based biosignal transmission

(unspecific origin) with feature extraction and self-learning or supervised learning functions, as well as a method and an Internet connected network with server-based services. These are limited in writing to contain at least data from a brain-computer interface. In the solution according to the invention, a use of a server is not provided, but just on the contrary the networking with each other, without the function of a server called parent control computer for exchange and

Data management.

Disadvantages also result from the fact that there are widespread and openly defined interfaces for medical devices, above all in the field of imaging methods, with which patient data and image data can be transmitted, namely HL7 and DICOM. These are not technically designed to allow device operation or to exchange information from devices in an operating room. Points such as time-critical data provision or even real-time capability as well as alarm management are not implemented.

Device systems are hitherto isolated from each other in terms of information technology in the operational environment. Networking all components offers enormous benefits for the user

Improvement of patient therapy, since

- more data is available

- Security against sensor failures is increased by redundant data

- Sensors can be saved

- Can be used on patient-specific device settings.

For this networking the necessary interfaces and

Communication protocols may be present in the medical devices.

In the area of application of the MIC, all devices used in the surgical procedure are currently recorded and documented manually in the preoperative phase. The

Device configuration and the setpoint adjustment are done so far purely manually by clinical personnel based on personal experience or manufacturer information.

So far, settings are performed within the operating room and during the medical procedure directly on the device. However, the device operation is due to the position close to the operating table and at the same time in the non-sterile Area of the surgery difficult to use. Persons who would be physically able to operate, come only poorly on the controls, as they are almost in the sterile area of the operating room. On the other hand, sterile personnel only have a poor access to the operating elements of the devices, whereby the medical devices are also mostly not sterile and sterility in the sterile area is ensured by sterile coatings. Therefore, the correct setting is often neglected and standard parameters are used. A statement from the sterile surgeon to the surgical nurse stationed in the immortal area for device operation is obvious. This disturbs the procedures of the medical procedures through technical processes and the success of a change of attitude depends strongly on the knowledge and the understanding of the surgeon / nurse team.

Anamnesis data is collected and logged before each surgery. Up to now, the use of this a priori data has only been done manually by the clinical staff,

For example, by changing the device parameters for older or younger patients. An automated evaluation by classification methods is currently not used to better tailor the therapy to the individual patient.

Focusing the problem on the MIC, a surgical technique that in contrast to traditional methods access to the patient on the smallest wound incisions and by the minor injuries of the skin layers provide many benefits for patients and complications such as trauma, scarring or infection reduced and shortening Convalescence achieved, resulting in poor regulation of body and joint internal pressures disadvantages by intraoperative

occurring swelling, post- and intraoperative complications and insufficient vision for the surgeon during an operation.

Currently, the use of pre-information about the patient or current information on the condition of the patient for the implementation of the MIC

exclusively by the medical professionals in the form of subjective

Adjustments to the device parameters or settings. An automatic

Data exchange between the MIC and other components in the operating room not done. This means that a large number of technical settings must be made by the surgeon (operating surgeon) on the basis of empirical values.

WO 2015/069 182 A1 describes a supplement to the control device of a

Pumping device by a blood pressure measuring device in an apparatus for

Purposes of improved control of pressure in a body cavity (pressure as low as possible, but high enough to prevent blood leakage from injured blood vessels). The solution described in this document describes in a specific embodiment the use of the data of a networked and separate apparatus, e.g. of a vital monitor, which supplies data, such as blood pressure, to an apparatus with a pumping device, e.g. a roller pump can use for a similar purpose.

Furthermore, WO 2015/069182 describes a method in which the measured blood pressure value is multiplied by a correlation factor in order to determine the blood pressure of the vessels there (true perfusion pressure) which controls the delivery pressure of the pumping device. The difference to the solution described in this document according to the invention thus lies in a communication layer between two independent and not necessarily originating from the same manufacturer medical devices that exchange data to such a control according to the teaching of

WO 2015/069 182 to effect. The solution according to the invention described in this document likewise includes the possibility of functionality WITHOUT such a connection or with a separate one in the course of the medical procedure

Connection.

In an attempt to avert these disadvantages by changing the settings of the device by the surgeon or the operating room nurse creates an increased

Communication effort, distraction, high workload and ultimately results in a concentration disorder of the surgeon.

The better networking, the integration of different data sources and sensors offer advantages for minimally invasive surgery over the current state of the art with conservative control technology and classical, non-automated Information Management.

These advantages are

- Improve the regulation and control of medical devices

- Adaptation of therapy to the patient - Automated logging and evaluation of patient and surgical data

- Implementation of an assistance system for the medical staff

- Error detection for devices and patient monitoring

During the actual surgical procedure, the patient therapy is improved by a patient-specific control of relevant physiological state variables compared to the previous state. At the same time the danger of

Minimized complications and reduced the duration of surgery. Shortening the surgery time with automatic presets that can otherwise be done manually. These are based on expert knowledge, patient information and OR data

During a clinical procedure, several medical devices interact directly or indirectly in the same area of operation. This is most evident in the area of interventions in body cavities, which are expanded by a medium and thus under pressure. Medical device for dilation are pumps or insufflators. Medical devices whose task it is to remove material, suck off this pressurized medium from, or create a leakage path on which the medium can escape. Thus, the fluid resistances for the introduction and the escape or aspiration of the medium are variables which influence a regulation, but are not always clearly coupled to one another in the current medical routine from the sensor data acquired with a medical device.

At present, in an artificial situation prior to the introduction of the medical devices into the body cavities, such fluid resistances are measured from the pressure and volume of a fluid exiting the free environment, ie the static pressure-flow characteristic, and from this an assumption about the existing fluid resistance up to Body cavity set. With this assumption, the situation in the body cavity is calculated and displayed to the surgeon via the technical parameters acquired during the medical procedure at the pumping device.

Disadvantage of this method is that it is relatively inappropriate and the surgeon can not oppose this period of time to a benefit and therefore often does not perform such advance detection.

An aid for device setting or a warning display, which can give context-sensitive recommendations for action, is only possible to a very limited extent in medical devices. Device tuning can only be done via additional selection of usage scenarios, such as the body region and the type of a procedure, for example via a selection in the device, a knee surgery and therapeutic intervention. Systems that use sensors and thus recognize a context are known from other areas, which are not operational in medicine because of the complex contexts. The use of vital parameters recorded outside the device for the generation of warnings or recommended actions is not known.

For a self-organizing networking relevant examples are known, which have not yet been used in the field of medical technology.

Further prior art can be found in the following documents: EP2662106B1 describes an insufflation device which has both a dissection mode and an insufflation mode. The

Insufflation device has an insufflator and a measuring, control and

Control device for the controlled and regulated output of the gas. The insufflator is fluidly connected via a gas supply line to a pneumatic tissue dissection probe. The tissue dissection probe is electronically connected to the measurement, control and regulation device. It is a switching device is provided which is designed to switch the regulated and

controlled gas flow to the gas output from the tissue dissection probe or from an insufflation cannula. An independent claim is for one Method for alternating insufflation of gas into a body cavity and pneumatic dissection simultaneously with an insufflation device.

WO2015 / 161965 describes the control of a medical device by means of different operating modes based on sensor data. The invention relates to a mobile medical device (1) with a portable operating unit, which has a housing (10) with a plurality of differently oriented or positioned

Controls on a user interface and at least parts of a

Control device (5). In order to give the operator substantial assistance, the operating unit comprises a position sensor device (3) which detects the orientation (x, y, z) of the housing (10) with respect to a reference value and generates sensor data accordingly. With orientation and different

Operating modes can be selectively activated by the control device (5) according to the sensor data.

WO2007 / 065237 describes an insufflator operation which automatically switches to a safety mode when there is no regular monitoring signal (page 5 lines 1-3).

DE19904090 describes a method and a device for automatic control and administration (including for documentation purposes) of

program-controlled medical devices. The focus of the patent is on the networking and communication of devices with a bus system (CANopen). Here, the medical devices act as slaves and the master computer as master, which can control all medical devices. In contrast to the solution according to the invention described here, the devices can not control each other or exchange data with each other. Functions include a macro recorder to define a combination of devices, a maintenance and service analysis at startup, a log-in file for specific documentation functions, a

Error logging and handling. Also described is a structure in a double ring structure, a ring-star structure or a ring-ring structure.

EP1995679 describes a device and a method for networking and central operation as well as data transmission for documentation purposes and / or control or parameter adaptation of at least one device which is during a medical intervention is used. Central is a database that is based on a

Control unit, an external accessible via networks server or a read-only volume is kept.

Paragraph [0016] EP1995679 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. In particular, a regulation of

Device parameters by sensor values, as the solution according to the invention shown here performs, is not described and not obvious.

Each transfer of the database contents into a device is necessarily linked in EP1995679 with a physician approval, ie the actuation of a confirmation element.

Paragraph [0028] EP1995679 describes that data of the patient (age, height, weight, existing or already recognized diseases, anatomical

Special features) require changed parameter values and device configurations and optimal parameters depend on the devices and manufacturers used. Paragraph [0029] describes their provision in the database and

various patient-dependent data sets or a formula for calculating patient-dependent parameters described. The technical teaching is exemplified by the interpolation or extrapolation. The solution according to the invention provides an evidence-based approach, so this is also not described or obvious.

EP 2763064 A2 describes an insulin pump with a configurator for setting operating parameters of the insulin pump. Inventive solution

To meet the challenges and shortcomings outlined above

The solution according to the invention provides for the use of medical and technical measured values which are already available in the operating theater through other device systems. The invention teaches a medical device for use in minimally invasive surgery (MIC) containing

at least one interface to at least one other medical device, the interface transmitting measurement data and / or patient data,

- At least one storage unit, which received the over the interface

Stores operating parameters based on measurement data and / or patient data and further contains at least one record operating parameter as a fallback level permanently,

at least one arithmetic unit in the other medical device connected via the interface, which calculates the operating parameters of the medical device based on the measurement data and / or the patient data, wherein the calculation of the operating parameters takes place taking into account apriori data selected according to a predetermined criterion the regulation of the operating parameters of the medical device on the calculated

Operating parameters.

The object which fulfills the solution according to the invention is a crosslinking of

Medical devices with each other without a central control device using the state of the art protocols that is used to improve the device function in terms of better control or regulation, identification of the discharge of the surgical staff and assistance in the choice of device parameters, the accessories and a simplified documentation.

The solution according to the invention can also be understood as the provision of a medical device (fluid pump) which, depending on the situation, is an ideal one

Operational support is ensured, whereby ■ the ideal surgical support consists of the combination of optimal operating modes and the appropriate disposables, Is defined ^■ the operation mode in each case by the pressure fluid flow, the control parameters and the adjustment range,

^■ selecting the optimal mode is either patient or intervention dependent;

■ Use a matrix that lists, weights, and links patient types and types of intervention, using exclusion criteria (non-allowed combinations)

^■ an algorithm that determines or suggests the ideal mode considering the matrix elements

»An adjustment and / or recognition of inserted disposables or other medical devices is carried out, and

^■ Depending on the result, the system is released, an alternative proposal is calculated, or the system is locked.

An embodiment of the fluid pump as a pure suction pump or as

pressurized reservoir is also according to the invention.

The automatic mode selection or a new protective mode primarily affect the following customer benefits: a) User-friendliness

The automatic mode selection relieves the operator of the need to make the settings themselves. It also minimizes the risk of operator error. b) pain reduction

The reduced distension caused by insufflation leads to a gentle one

Treatment and thus to the best possible avoidance of pain in the patient. c) Medical added value

Using the modes described here results in the greatest possible

Reducing the burden on the patient and may also be the basis of

Treating high-risk patients. The basic idea of the invention can be broken down into

- Patient data-reactive device control

- Assistance system (relief of technical setting parameters, warning of critical conditions, visualization of the process and the remaining margins)

The prerequisite is the provision of data interfaces to sources of information in the operational environment, such as the hospital information system or the

Anesthesia system and the specification of relevant information sources and interfaces. The solution according to the invention includes a

- Data communication layer for networking devices in the OR

- Data classification of Apriori anamnesis data

- Identification method for automatic detection of used

Devices in the preoperative phase - Set of preselector settings based on Apriori knowledge

- Setpoint recommendations based on Apriori knowledge

- Data transfer from the preoperative phase to the assistance system

- Furthermore, for optimum insufflation, a comparison should be made as to whether the disposable selected in the specific individual case harmonizes with the calculated mode

Providing a protective mode, so that it is possible for the surgeon for particularly sensitive cases (infants / seniors) if necessary, to optimize the functioning of the device with respect to the patient well-being.

Data classes (e.g., patient type, operation type) are created and the

associated anamnesis data. Derived from the data analysis

The setpoint recommendations and controller presets of the medical devices improve patient therapy and flow into an assistance system to support the clinical Personnel. Patient therapy is thereby significantly improved, for example, by reducing bleeding and / or preventing unwanted tissue damage due to excessive pressure in the operating area. The assistance system supports the surgeon with customized recommendations based on patient data and technical measurements.

According to the invention, source and control parameters of insufflators and pumps in the inim-invasive surgery in the medical device are changed directly or indirectly by data input, whereby an improved device function is ensured, which improves the view in the surgical field, reduces bleeding, and the burden on the patient's circulation minimized.

By proposed as a solution according to the invention combination of all pre-, intraoperative patient and surgical information, the surgeon or the clinical staff of technical configuration procedures of the devices used can be relieved. For the solution of the defined problems according to the invention, the analysis and acquisition of new data in the preoperative phase and the derivation of

Device configurations from the data.

While the actual surgical procedure is taking place, devices of the MIC have been isolated in their own right and are only linked to clinical information via the adjustments made by the operating surgeon. By automatically taking into account all available medical and technical data from different data sources, adjustments of the device parameters and settings should be made and better regulation and presetting of operating room-related parameters should be realized. All apriori data from the preoperative phase should be used for automatic device adjustment. The device configuration should be automated in the form of controller parameters and setpoint specification.

These include:

- Parameter control when using non-invasive measuring methods

- Inclusion of device activities that have an influence on the function of the medical devices - Proposal of the operation optimally supporting medical devices or disposables (eg tube set)

Preselection of an operating mode which optimally supports the operation

- adaptation of the control parameters to the patient - use of a monitoring layer and fallback level

- Methods for automatic data processing and classification

- Methods for automated device detection

- Methods for apriori controller adjustment and setpoint recommendation

- Methods for integrating and using information sources available in the operating room but not yet included

In order to counteract the problem of inter- and intra-patient variability during the intraoperative phase, a constant adaptation of the regulations to the patient taking into account current vital parameters is undertaken.

According to the invention, an automated history evaluation, the current

Patient data linked with prior knowledge. The device systems used during the procedure should be automatically recognized by means of identification methods. Furthermore, action recommendations for the surgeon are generated from all available apriori data.

According to the invention is also a self-adjustment of the equipment used, which relieves the medical staff of technical processes and the therapy optimized patient-specific. All collected information, setpoint recommendations and settings should be transferred to the intraoperative phase.

So far, little attention has been paid to the algorithm-based information analysis before an operation. In this preoperative phase, a large number of patient and surgical data are already generated and can be analyzed. in the

Individuals are possible in the preoperative phase the collection of information through a data interface to the

Patient management system,

- the performance of an anamnesis evaluation,

- the execution of an automatic device recognition, - the regulator presetting for the surgical procedure,

- The preselection of an operating mode optimally supporting the operation

- the proposal of the operation optimally supporting medical devices or

Disposables (e.g., tubing set)

- the output of setpoint recommendations for the surgical procedure and - the simple adoption of recommendations and controller default settings.

The expanded exchange of information between the device systems in the clinical-operative environment is used directly for optimizing the control technology of the individual medical devices.

Automated information processing analyzes and classifies patient and device data and derives device parameters and device behavior. The

Classification procedure corresponds to established procedures and for everyone

Scope, a suitable classifier structure is created. The training and the validation of the classifier takes place before the implementation in the

Medical device or even during the medical procedure or following the medical procedure by e.g. learning systems using data from the clinical environment.

In addition to using existing information, process information is collected, analyzed and used for other networked medical subsystems

provided. The area of application of the planned expert system may include further functional units in the operating room. Thus, the most important area of anesthesia greatly benefits from a constantly updated experience system and the connections to other clinical devices and systems. Data from the anamnesis and device discovery allows device configurations to be automatically selected. These settings can be optimized for each individual patient to the respective therapy and thus improve preoperatively minimally invasive surgery. The same applies to setpoint specifications such as the pressure in the operating area.

For identification of medical devices connected to the fluid system (shaver, tubing set, trocar, etc.), the relevant device parameters are currently used by assuming various operating states (flow rates and delivery pressures in fluid pumps) in order to determine the relevant variables (flow resistance) or in advance to compare measured sizes. This method is based on the

Involvement of the surgical staff and costs a lot of time. According to the invention, a provision of the device identifications from the surgical planning system, a labeling of the medical devices with RFID chips (wireless data transmission) or a visual recognition by image processing of connected devices or other methods can be carried out to determine the device settings resulting from the use

make.

In medical technology, a core element of any product development is the

Ensuring patient safety. According to the invention, critical

Patient conditions detected and in case of failure, the system in a safe

Operating mode to be transferred. This task is taken over by a fallback level.

The fallback level in the medical device ensures that it also assumes a safe state in the event of missing or failing procedures

Data inputs. It will keep certain sizes, if necessary, change other sizes to a safe mode.

All information and the preoperative controller settings and setpoint recommendations are also available to the assistance system. This

Assistance system is available to medical personnel in the pre- and intraoperative phase and relieves them of technical procedures. On the basis of, among other things, anamnesis data, type of intervention, types of patient and current vital parameters of the patient, the clinical personnel are given recommendations for action by an inventive assistance system, such as increasing an initial target pressure recommendation or the target pressure and / or indicating critical conditions, such as a longer-term one high pressurization or high storage of fluid in the body. Also, a special operating mode or hose (eg, with humidification or heating) that best suits the upcoming OP may be proposed.

Exemplary embodiments The provision of a data interface to the patient management system can take place with a built-in device or via a middleware and the

Provide and manage communication between the various data sources in the operating room. Thus, the devices of the MIC are integrated into the self-organizing communication network. Pre-sorting based on clinical expertise divides the apriori data into data classes (e.g., patient type, operation type). For this purpose, a set of rules for the regulator presetting for pressure control is used. Possible apriori knowledge is e.g. the type of surgery, anonymized patient parameters such as age, height, weight, etc. or

physical properties of the devices used. Due to the changing characteristics of the device-patient system, a controller selection should be made to employ a specialized rather than generic controller structure, i. a control algorithm explicitly tailored for the control task instead of a generally usable control algorithm which is adapted in each case with parameters to the current task. One embodiment of automated information processing is to evaluate data accumulated during the procedure by a patient vital parameter analyzer or analysis method. This has the task, for example, the pressure in the operating area exactly the blood pressure in the surrounding tissue

which would be ideal from a clinical point of view. Ideal means that a pressure difference of zero does not lead to bleeding in the control area, nor to undesirable fluid entry into the body by the distension or Flushing medium. At the same time, the lowest possible pressure in the operating area should be aimed at in order to reduce the tendency for tissue swelling (arthroscopy), increased pressure in order to reduce bleeding into the operating area (arthroscopy and general endoscopy). The optimal setpoint for the pressure in the operating area is determined from the vital parameters of the patient before the surgical procedure. Here, for example, the age of the patient is an influencing variable to from general biomechanical conditions, such as the pressure-resistance of

Joint capsule, so the filling pressure before a crack occurs to determine a target value for the pressure in the operating area. Also during the surgical procedure vital parameters of the patient are used, for example, from the diastolic blood pressure or another value associated therewith to determine setpoints for example, the pressure in the operating area.

To achieve this balance between the required boundary conditions such as view of the interior of the joint and irrigation and acute or creeping damage due to excessive pressure, the core element of the control loop, ie the method of adaptation to the individual patient, the inclusion of

Contextual information provided through the networked data. In a certain OP context, in the regulation of pressure by means of a

Dual roller pump is the peripheral condition maintaining a of

Surgeon demanded volume flow through the operation area. Both are done, for example, with the approach provided over the network, current

Vital parameters of the patient in the control concept of the medical device

included. One aspect represents the setpoint adjustment for the pressure in the operating area. the intraoperatively measured blood pressure value, the body temperature, the heart rate or data from the anesthesia are taken into account. Furthermore, the setpoint recommendation is constantly adapted to the individual state during the operation. Another aspect is the consideration of vital parameters in the

Controlled variable observation or estimation. Previous concepts are based on pure technical measurements. The vital data uses biological signals within the control concept. This means that out of changes the

Vital parameters a control variable estimate is influenced, whereby additional information is included as controlled variables. In addition to the method of parameter estimation, multivariate regression analysis is used. Next

Vital information also comes from the networking of medical devices with each other and their connection to existing hospital usual

Data sources. The inclusion of additional data sources can be used universally for a variety of regulatory structures. The specifications of the preoperative regulator presetting should be checked and, if necessary, adjusted to ensure optimal therapy. The regulatory optimization of medical devices takes the form of

Regulator presets and setpoint recommendations.

A controller setting is done so far only by technical

Skilled personnel during maintenance work. This can be done according to the invention by self-learning systems and / or central data sets with an optimized selection of evidence-based parameter sets. The parameterization of

Control structures for different types of patients and operations are provided by validated process models available in silico or as HIL laboratory setups, which are further improved by sufficient process data. HIL means hardware-in-line, i. that technical representations of the operating environment by means of active elements with a background control simulate the operating theater situation and reactions to device actions as identical as possible. This allows controlled and documented environmental conditions against which the device control can be reproducibly optimized.

So far, technical process variables are hardly analyzed and almost never evaluated in the context of the clinical outcome. According to the invention, an information collection, evaluation and information-based

Process optimization anonymized and still patient-specific. From this it can be deduced that the automated linking of preoperative knowledge with the intraoperative procedure carries the risk of individual over-adjustments. The Definition of data and model structures and nonlinear optimization depend on the data set used and the structure chosen, where

in particular the risk of overfitting exists. This is avoided, for example, according to the prior art by a separation of training and validation data (leave-one-out validation). Another

promising solution according to the prior art for

Over-adaptation prevention is supported by Support Vector Machines (SVMs) from statistical learning theory. Here, individual data sets are considered as a random sample from an unknown population. The goal is to find a description that is not optimal for the record, but for the population. SVMs therefore have a much better generalization behavior than previously used approaches.

Adapting the control to the patient requires the use of closed-loop identification procedures for reasons of safety and economy. The sufficient process excitation for identification and damping of the process excitation by the control are designed according to the prior art.

Those in use in the hospital environment

Standard computer systems are currently characterized by a strict separation of the real and virtual worlds. Future MIC system solutions will be characterized by intelligent surgical units with networked system components, intelligent sensors and actuators. The widely used embedded systems today do not meet these requirements. Future MIC system solutions will strengthen the networking and intelligent control of diverse physical and virtual single systems. This can only succeed if the paradigm shift from centrally controlled processes to holistic approaches is carried out involving all available and usable sources of information.

Solutions according to the invention are based on Cyber Physical Systems. in the

Unlike embedded systems, cyber-physical systems consist of networked and autonomously coordinated system components. These components grow together into an automatically interacting, intelligent system environment and merge integratively with reality. By definition, they are complex and consist of many heterogeneous and partly autonomous components and modules. Therefore, there is a need to create common definitions, standards, and intelligent interfaces for MICs to safely and successfully operate medical device systems for MICs through integrated management technologies.

Also according to the invention is a reliable and time-efficient method for identifying the medical devices used for the operation. For example, in the field of arthroscopy, the flow properties of the used

Dual roller pump, the hose unit and the trocar-optic combination are determined, whereby an increase in the regulator quality in the intraoperative phase by taking into account Apriori knowledge, for example, the use of prior art flow characteristics of the identified medical devices. Currently, the detection of used devices is mostly done manually by the medical staff. In the prior art, manufacturers identify their own accessories by suitable devices, such as e.g. RFID. The automated device recognition of all applicable medical devices requires reliable

Sensor information and robust identification algorithms. Due to safety aspects, recognition is often only possible in the preoperative phase. Error detection or lack of convergence of the identification algorithms can lead to false assumptions in device control. A parameter estimation for the purpose of system identification takes place according to the invention in

closed circle. Furthermore, according to the prior art, the

Possibilities of indirect identification and direct identification. An adaptation of device-internal controls to the individual patient is done so far only subjectively and manually by the medical staff. Setpoint specifications are made manually by medical personnel based on individual experience. When deriving recommendations for action it is absolutely necessary to identify a correlation between relevant clinical process variables and a clinical result and to identify them from the identified ones

Correlations derive a causality. If this does not succeed, there is a risk of deriving incorrect recommendations for action. The determined causalities become provided according to the invention for use in the device adaptation (including setpoint specifications, accessory recommendations, controller method selection, recommended actions) in the medical device.

According to the invention, an assistance system is provided to the surgeon during each

Surgery in the field of minimally invasive surgery is available. This concept offers great potential for other areas in the clinical environment and is to be used for areas such as anesthesia, rehabilitation therapy or the field of dialysis. As a continuation of the assistance systems is a

Feedback of the information conceivable, so for example, the pressure in the joint as a setpoint / guide information for the anesthetists for blood pressure adjustment in the vital data monitor is displayed.

The networked medical device can also be used for less time-consuming surgical documentation. The background is that experiences about performed operations are not sufficiently evaluated, documented and published. This is also due to missing data, which makes the networked medical device to one

Memory unit can output for subsequent evaluation.

In one embodiment, the device according to the invention consists of a medical device which is connected via an interface to the hospital network, for example a secure network connection with medical devices in the operating theater, measurement data from sensors, information about the patient who is treated with the medical device, and operating parameters of the medical devices can exchange. This

Medical device includes a storage unit, wherein the data to be assigned to each case of treatment are collected and stored in a structured manner. In the event that operating parameters or patient data are only partially transmitted, e.g.

due to connection problems, the device becomes a record

held, which is used in such cases as a fallback level and safe operation of the medical device, which has sent the data allows. The

Medical device will also resort to this fallback level in case of missing or interrupted connection. The medical device contains a computer unit, which due to higher-level rules and / or the evaluation of the Interface incoming data calculates operating parameters and applies these for their control / regulation. One type of such calculation may be a simple correlation of the incoming data sets existing in the medical device. Other links and calculations according to the prior art, which provide operating parameters for the further operation of the medical device, are also according to the invention. Alternatively, data can be sent to an external database or expert system which can be reached via the interface, and operating parameters can be transmitted back.

A concrete embodiment of such a medical device is a

Fluid pump that introduces a pressure in an artificial or created body cavity to dilate. This may be a fluid-filled body cavity, such as in urology, hysteroscopy, arthroscopy, and procedures where tissue is disrupted to allow access to certain regions and implants, such as in total extraperitoneal hernia repair. According to the invention can in a

fluid-filled body cavity, the intracavitary pressure by the use of suction or therapy devices that remove tissue, quickly lowered, causing the body cavity to shrink. The communication from the aspirating therapy devices that they are activated, via the aforementioned interfaces can allow the liquid pump to respond quickly, because the pressure drop can otherwise be assigned to a suction situation with delay. Also according to the invention is the strength of the

Suction by the identification of the device used and its known parameters or by the strength of the device activity via the interface in the pump to transmit or request this.

In another embodiment, the task of the fluid pump is to keep the field of view clear, e.g. Bleeding through opened blood vessels and capillaries. This can be done by a tamponade effect, ie by a generated fluid back pressure to the local blood pressure in the opened vessels. At the same time should be avoided to squeeze the expansion fluid by pressure in the blood vessels.

According to the invention, it is therefore necessary to detect the blood pressure with a measuring device, which is done, for example, by the anesthesiologist by means of a vital monitor, which is a contains such measuring device, and to transmit this information - but also other - via the interface to the medical device. Thus, when the fluid pump receives the measured blood pressure of the patient, the local blood pressure at the body cavity is calculated by calculation, and the local blood pressure and / or the transmitted blood pressure are directly processed as a control parameter for the pressure in the body cavity.

According to the invention, the billing of other vital parameters or

Patient data, including, for example, the inclusion of the patient's age on the maximum allowable pressure values of the fluid pump or the body mass index calculated from weight and height, which corresponds to the weight of the abdominal wall in the case of

Expansion of the abdominal cavity (laparoscopy) is taken into account as a parameter for increasing the setpoint pressure.

In the case of a liquid pump, the operating parameters of the medical devices influenced by the invention are the fluid pressure generated by the pump and / or the fluid flow generated, that is to say the quantity which is conveyed per unit of time. Also according to the invention is the regulation of the fluid temperature, which can be done with insufflator by special air hoses and fluid pumps by accessories, which introduces heat into the flushing medium. This accessory may also be controlled by the temperature values determined by external sensors, e.g. also connected to the vital monitor are controlled.

Claims

claims

1.) Medical device for use in minimally invasive

Surgery (MIC) containing

- at least one interface to at least one other

medical device, the interface transmitting measurement data and / or patient data,

at least one memory unit which stores the operating parameters obtained via the interface on the basis of measured data and / or patient data and which furthermore permanently contains at least one data set of operating parameters as a fallback level,

at least one arithmetic unit in the other medical device connected via the interface, which calculates the operating parameters of the medical device based on the measurement data and / or the patient data, wherein the calculation of the operating parameters takes place taking into account apriori data selected according to a predetermined criterion the regulation of the operating parameters of the medical device takes place on the calculated operating parameters.

2) Medical device according to claim 1, wherein it is in the

medical device is a fluid pump.

3) Medical device according to claim 2, wherein it is in the

Fluid pump is an insufflator or a liquid pump.

4) Medical device according to at least one of the claims

Claims 1-3, wherein the at least one interface measured data of a

Transmits blood pressure measuring device and / or other vital parameters of the patient and / or patient data of an electronic patient record. Medical device according to at least one of claims claim 1-4, being regulated as operating parameters fluid pressure, fluid flow and / or fluid temperature.