APPARATUS AND METHOD FOR LINKING AND EVALUATING INFORMATION IN CLINICAL DATA IN A MEDICAL DEVICE

Abstract

The subject matter of the invention is a medical engineering device for use in minimally invasive surgery (MIS). Until now, minimally invasive surgery (MIS) as a device solution is isolated from the networked components of the operating room. The medical professionals are to be assisted in the device setting by an assistance system, by a better integration of the devices used for the MIS (e.g., insufflators, pumps, cameras, monitors) in the total surgery process as well as by a manufacturer-independent, open approach for information collection, information evaluation, and information-based process optimization. In the pre-operative phase already, before the actual surgical intervention, a multitude of information can be collected or acquired, in order to make them available in the intra-operative phase. At the same time, on this basis of data, a first individualization of the diagnostics or therapy to the respective patient can be performed.

Claims

1. A medical engineering device for use in minimally invasive surgery (MIS), including at least one interface to at least one other medical device, wherein the interface transmits measurement data and/or patient data, at least one storage unit that stores the operating parameters obtained via the interface based on measurement data and/or patient data and that further permanently contains at least one data set of operating parameters as a fall-back level, at least one computation unit connected via the interface in the other medical device, which based on the measurement data and/or the patient data computes the operating parameters of the medical device, wherein the calculation of the operating parameters takes place under consideration of a priori data selected according to a predetermined criterion, wherein the regulation of the operating parameters of the medical device takes place using the calculated operating parameters.

2. The medical engineering device according to claim 1, wherein the medical engineering device is a fluid pump.

3. The medical engineering device according to claim 2, wherein the fluid pump is an insufflator or a liquid pump.

4. The medical engineering device according to claim 1, wherein the at least one interface transmits measurement data of a blood pressure measurement device and/or other vital parameters of the patient and/or patient data of an electronic patient record.

5. The medical engineering device according to claim 1, wherein as operating parameters, fluid pressure, fluid flow, and/or fluid temperature are controlled.

Description

EMBODIMENTS

[0128] The provision of a data interface to the patient management system can be achieved with a built-in device or through a middleware and provide and manage the communication between the different data sources in the operating room. Thus, the devices of the MIS are incorporated in the self-organizing communication network. A pre-sorting process based on clinical expertise divides the a priori data into data classes (e.g., type of patient, type of surgery). For this purpose, a compilation of rules for the controller pre-setting is utilized for the pressure regulation. Potential a priori knowledge is, e.g., the type of surgery, anonymized patient characteristics as age, height, weight, etc., or physical properties of the employed devices. Due to the changing properties of the system of device and patient, a controller selection is to be made, in order to employ a specialized instead of generic controller structure, i.e., a control algorithm explicitly tailored for the control task instead of a generally useful control algorithm that is respectively adapted with parameters to the current object.

[0129] An embodiment of an automated information processing evaluates data generated during the procedure by an analysis device or analysis method for the patient's vital parameters. The object is, for example, to adjust the pressure at the surgery site exactly to the blood pressure in the surrounding tissue, which would be ideal from a clinical point of view. Ideal means that by a pressure difference of zero neither bleedings in the control area nor undesired fluid entry into the body by the distensions or rinsing medium will occur. At the same time, an as low pressure as possible at the surgery site is desired, in order to lower the tendency to tissue swellings (arthroscopy), increased pressure, in order to reduce bleedings at the surgery site (arthroscopy and generally endoscopy) The optimum set value for the pressure at the surgery site is determined before the surgical intervention from the vital parameters of the patient. Herein, for example, the age of the patient is an influence quantity, in order to determine from general biomechanical circumstances, such as the pressure resistance of the joint capsule, i.e., the filling pressure before a crack occurs, a set value for the pressure at the surgery site.

[0130] During the surgical intervention, too, vital parameters of the patient are used, for example, from the diastolic blood pressure or another value linked therewith, in order to determine set values for the pressure at the surgery site, for example.

[0131] In order to achieve this balance between the required boundary conditions such as vision on the joint interior and rinsing and acute or insidious damage by too high pressure, the core element of the control loop, i.e., the method for adaptation to the individual patient, is the inclusion of context information that is made available by the networked data. In a certain surgery context with the regulation of the pressure by means of a dual roller pump, the boundary condition is the maintenance of a volume flow required by the surgeon at the surgery site. Both are achieved, for example, with the approach to include current vital parameters of the patient provided via the network in the control concept of the medical device.

[0132] One aspect is the set value adjustment for the pressure at the surgery site. Vital parameters such as the intra-operatively measured blood pressure value, the body temperature, the heart rate or data from the anesthesia are to be taken into account. Furthermore, the set value recommendation is adjusted, also during the surgery, continuously to the individual condition.

[0133] Another aspect is the consideration of vital parameters for the control quantity observation or estimation. Current concepts are based on purely technical measurement quantities. With the vital data, biological signals within the control concept are used. This means that from changes of the vital parameters, a control quantity estimation is influenced, thereby additional information being included as a control quantity. For this purpose, in addition to methods of parameter estimation, also the multivariate regression analysis is used. In addition to vital parameters, information also originates from the networking of medical devices among each other and the combination thereof with existing data sources that are common in the hospital. The inclusion of additional data sources can be used in a universal manner for a multitude of control structures.

[0134] The provisions of the pre-operatively performed controller pre-setting should be checked and, if necessary, be adjusted, in order to ensure an optimum therapy. The control optimization of the medical devices occurs in the form of controller pre-settings and set value recommendations.

[0135] Until now, a controller setting is made exclusively by technical professionals in the context of maintenance works. This can be achieved, 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 types of surgeries is made by validated in silico models or process models available as HIL structures that are further improved by sufficient process data. HIL means hardware-in-line, i.e., technical representations of the operational environment by active elements with a controller acting in the background copy as identically as possible the surgery situation and reactions to device actions. This enables controlled and documented environmental conditions, in relation thereto the device control can reproducibly be optimized.

[0136] So far, technical process parameters were rarely analyzed and evaluated in the context of the clinical result (clinical outcome). According to the invention, an information collection, evaluation, and information-based process optimization is done in an anonymized manner and nevertheless tailored to the patient's individual needs. Therefrom follows that the automated linkage of pre-operative knowledge with the intra-surgical intervention carries the risk of individual overfittings. The determination of data and model structures as well as the non-linear optimization depend on the used data set and the chosen structure, with in particular the risk of overfitting. This is avoided, for example, according to prior art by a separation of training and validation data (leave-one-out-validation). Another promising solution according to prior art for preventing overfittings is offered by support vector machines (SVMs) from the statistical learning theory. Herein, individual data sets are considered as a random sample from an unknown basic population. The object is to find a description that is not optimal for the data set, but for the basic population. SVMs, therefore, have a significantly better generalization behavior than previously employed approaches.

[0137] The adaptation of the control to the patient requires, for reasons of safety and economy, the use of identification methods in closed loops. The sufficient process excitation for identification and the damping of the process excitation by the control are designed according to prior art.

[0138] The standard computer systems for use in the hospital environment are currently characterized by a strict separation of the real and virtual worlds. Future MIS system solutions will comprise intelligent surgery units with networked system components, intelligent sensors, and actuators. The embedded systems being widely used today do not meet these requirements. Future MIS system solutions will intensify the networking and intelligent control of different physical and virtual single systems. This will only be successful when the paradigm change of centrally controlled processes to holistic approaches is carried out with the inclusion of all available and usable information sources.

[0139] Solutions according to the invention are based on cyber-physical systems. Different from embedded systems, cyber-physical systems consist of networked system components autonomously coordinating themselves. These components consolidate to an automatically interacting, intelligent system environment and fuse integratively with reality. By definition, they are complex and consist of many heterogeneous and partly autonomously operating components and modules. Therefore, there is the necessity to create uniform definitions, standards as well as intelligent interfaces for the MIS, in order to safely and successfully operate medical device systems for the MIS through integrated management technologies.

[0140] There is also provided according to the invention a reliable and time-efficient method for identification of the medical devices used for the surgery. For example, in the field of arthroscopy, the flow properties of the employed dual roller pump, of the hose unit and the trocar-optics combination are to be determined, thereby an increase of the control performance in the intra-operative phase by consideration of a priori knowledge occurs, for example, the use of known flow properties of the identified medical devices. Currently, the recognition of used devices mostly takes place manually by the medical personnel. According to prior art, manufacturers identify their own accessories by suitable devices, such as RFID. The automated device recognition of all usable medical devices requires reliable sensor information and robust identification algorithms. A recognition is often, due to safety aspects, only possible in the pre-operative phase. Faulty recognition or a missing convergence of the identification algorithms may lead to erroneous assumptions for controlling the devices. A parameter estimation for the purpose of system identification occurs, according to the invention, in the closed loop. Furthermore, according to prior art, there are possibilities of indirect identification and direct identification.

[0141] Up to now, an adaptation of device-internal controls to the individual patient is made exclusively subjectively and manually by the medical professionals. Set value inputs are made manually by the medical personnel using individual experiences. For the derivation of recommendations for action, it is absolutely necessary to identify a correlation between relevant clinical process parameters and a clinical result and to derive a causality from the identified correlations. When this is not successful, there is the risk to derive erroneous recommendations for action. The determined causalities are provided, according to the invention, for the use in device adaptation (among others, for set value inputs, recommendations of accessories, selection of control methods, recommendations for action) in the medical device.

[0142] According to the invention, there is provided an assistance system that is available for the surgeon during every intervention in the field of minimally invasive surgery. This concept offers a high potential for further areas in the clinical environment and is to be used for the fields such as anesthesia, rehabilitation therapy or dialysis. As an extension of the assistance system, a feedback of information is imaginable, i.e., for example, the pressure in the joint is displayed as set value/guide information for the anesthesia doctors for blood pressure adjustment on the vital data monitor.

[0143] The networked medical device may also be used for a less time-critical surgery documentation. Background is that experiences about performed surgeries are not sufficiently evaluated, documented and published. This is also due to missing data that the networked medical device can output to a storage unit for later evaluation.

[0144] The device according to the invention consists, in one embodiment, of a medical device that can exchange, via an interface to the network of the hospital, for example, a safe network connection with medical devices in the surgery area, measurement data of sensors, information about the patient who is treated with the medical device, and operating parameters of the medical devices. This medical device includes a storage unit, wherein the data respectively assigned to a treatment case are collected and recorded in a structured manner. In case that operating parameters or patient data are only partially transmitted, e.g., due to connection problems, a data set is kept in the device that in such cases can be used as a fall-back level and enables a safe operation of the medical device, which has sent the data. With missing or interrupted connection, the medical device, too, will take recourse to this fall-back level. The medical device contains a computing unit that, due to superordinate rules and/or the evaluation of data entered via the interface, computes operating parameters and uses them for control/regulation. One kind of such a calculation may be a simple correlation of the incoming data sets existing in the medical device. Other linkages and calculations according to prior art that provide operating parameters for the further operation of the medical device, are also provided according to the invention. Alternatively, data sent to an external database or expert system, i.e. accessible via the interface, and operating parameters can be transmitted back.

[0145] A specific embodiment for such a medical product is a fluid pump that supplies a pressure in an artificial or created body cavity for expansion. This may be a liquid-filled body cavity, as is the case, for example, in urology, hysteroscopy, arthroscopy, as well as in procedures, in which tissue is opened, in order to enable access to certain regions and introduce implantations, as, for example, in the total extraperitoneal hernioplasty. According to the invention, in a liquid-filled body cavity, the intracavitary pressure can quickly be reduced by the use of suction instruments or therapy devices that remove tissue, thereby the body cavity becoming smaller. The communication of the sucking therapy devices to activate them via the already mentioned interfaces can enable the liquid pump to respond quickly, since otherwise the pressure drop will only be assigned with a delay of a suction situation. Further, according to the invention, it is provided to transmit or query the intensity of the suction by the identification of the employed device and the known parameters thereof or by the intensity of the device activity via the interface to the pump.

[0146] In another embodiment, the object of the fluid pump is to keep the field of vision free, e.g., from bleedings by open blood vessels and capillaries. This can be achieved by a tamponade effect, i.e., by a generated fluid counterpressure to the local blood pressure in the open vessels. At the same time, it is to be prevented to press the expansion fluid by overpressure into the blood vessels. According to the invention, it is, therefore, provided to detect the blood pressure with a measuring device, which is done, for example, by the anesthetist by means of a vital monitor that contains such a measuring device, and to transmit this informationbut also othersvia the interface to the medical device. When, thus, the fluid pump obtains the measured blood pressure of the patient, the local blood pressure at the body cavity is calculated, and the local blood pressure and/or the transmitted blood pressure are directly processed as control parameters for the pressure in the body cavity.

[0147] According to the invention, there is also provided the calculation of other vital parameters or patient data, for example, the inclusion of the patient's age to the maximum admissible pressure values of the fluid pump or the body-mass index calculated from height and weight that is taken into account with the weight of the abdominal wall for the expansion of the abdominal cavity (laparoscopy) as parameters for an increase of the set pressure.

[0148] The operating parameters of the medical devices processed according to the invention are in the case of a liquid pump the fluid pressure generated by the pump and/or the generated fluid flow, i.e., the supplied amount per time unit. According to the invention, there is further provided the control of the fluid temperature, which in the insufflator can occur by special heating hoses and in fluid pumps by accessories applying heat to the rinsing medium. These accessories can also be controlled by the temperature values determined by external sensors, such as, e.g., they are also connected to the vital monitor.