SYSTEM AND PROCEDURES FOR VALIDATION AND TRAINING OF SURGICAL PROCEDURES IN HUMAN AND VETERINARY MEDICINE

Description

[0001] The invention relates to a system and a method for validating and training surgical interventions in human and veterinary medicine, which comprises a training model anatomically modeled on the human or animal body.

[0002] Parameters are defined that provide information about the learning success, the quality, and thus the success of the practiced procedure. The practiced procedures include surgical and minimally invasive surgical techniques, such as implant placement, which are practiced under realistic conditions on a training model.

[0003] The training model comprises an anatomical replica of a body part, an anatomical replica of an interchangeable training region, and an optoelectronic detection device. The optoelectronic detection device is arranged in the recess of the anatomical replica of the body part in such a way that it is designed to record surgical procedures and monitor the positioning of surgical instruments and / or implants on the back of the interchangeable training region. Furthermore, the training model comprises a storage medium that is detachably connected to the interchangeable training region.

[0004] The surgical procedure being practiced is supported by a dataset. Authentic injuries to risk structures (e.g., vessels or nerves) are also automatically displayed.

[0005] The subject of the present method is the validation and training of surgical interventions in a training model anatomically modeled on the human or animal body using the system according to the invention.

[0006] Various validation and training procedures using training models are known for training surgeons and for pre-testing complex and minimally invasive surgical procedures prior to the actual operation. Systems with external tracking cameras are described, for example, in the "PHACON 3D LIFE MODELLING & SIMULATION Product Catalogue 2016," September 30, 2016 (2016-09-30), pages 1-26, XP055464062.

[0007] US 2001 / 0019818 A1 describes an anatomical model for training cardiac surgery using endoscopic methods. The model includes anatomically realistically reproduced bones and organs, as well as skin layers. The organs can be made transparent for better visualization. Furthermore, the possibility of providing lighting inside the model is described. However, the model does not allow for automated control or feedback to the user regarding the procedures performed.

[0008] US 2014 / 0057236 A1 describes a combined system consisting of an anatomical model for training surgical procedures and a virtual representation of the surgical field. A virtual representation of the surgical field is generated on a display positioned between the surgeon and the model, while the surgeon simultaneously manipulates the underlying model. This creates an overall perception that is intended to create the most realistic feeling possible for the surgeon. The system also provides the user with feedback on the correct positioning of drill holes in bone. This is intended to help the user learn the exact positioning of the drill holes. A disadvantage of the system, however, is the limited perception due to the limited virtual representation.

[0009] WO 2012 / 044753 A2 discloses a portable device for training laparoscopic procedures. The system is suitable for practicing endoscopic procedures. The model can also feature LED lighting below the surface for illuminating simulated body cavities.

[0010] WO 2013 / 165529 A2 discloses a system and method for analyzing surgical techniques, wherein the progress of the surgical procedure is recorded and assessed using optoelectronic detection means. For this purpose, dyes are located in some layers of the model, which are detected by the system.

[0011] WO 2015 / 138982 A1 describes a model for training laparoscopic procedures. The surgeon is guided by the structure and design of the muscle layers beneath the simulated skin layer. This helps identify an incorrect access site. To verify the correct puncture site, the model can be turned over and inspected from the back. However, this requires aborting the procedure. Furthermore, this model does not allow for direct monitoring of the surgical techniques.

[0012] Finally, DE 11 2006 003 722 B4 discloses a simulation system for surgical interventions in human and veterinary medicine.

[0013] It would therefore be highly desirable to provide a system that records the processes taking place within the training model and informs the user in real time about the training success and the positioning of the surgical instruments and / or implants.

[0014] DE 20 2012 011 452 U1 discloses a neurosurgical training system for planning and performing a craniotomy for brain tumors. The training system consists of, among other things, a skull-like phantom, a control, measurement, and evaluation unit, and a unit for detecting and tracking the instruments used during training. The control, measurement, and evaluation unit contains a storage unit for storing individual patient data records.

[0015] DE 10242953 A1 describes a device for training simulated navigation-assisted surgical procedures. Surgical instruments are controlled by a navigation system. Furthermore, a patient data set obtained by imaging techniques such as tomography scans and three reference points that are not located in a single plane and are assigned to the patient's body in a fixed position are available. The navigation system is equipped with a model of the patient's body, which has three additional reference points that can be detected by the navigation system. The patient data set is assigned to the model in such a way that the respective reference points coincide.

[0016] Document DE 10143712 A1 discloses a method, computer system, and computer program product for data analysis and improved patient care. The data analysis is intended to be used as an internet-based, patient-specific prognosis system, particularly for cancer. The dataset contains clinical-pathological data and follow-up information. Furthermore, a reference database is used for comparison.

[0017] DE 10 2008 014 709 A1 describes an image-guided surgical expert system that serves to access, store, and exchange medical information between imaging devices during surgical procedures. The acquired data is compared with reference data, for example, from a medical record, to improve the procedures.

[0018] EP 1348393 A1 describes a method for computer-assisted medical navigation. A position detection unit detects the position of the patient and the position of treatment devices. Body structure data is associated with this position data. The body structure data was obtained based on a generic model that was adapted by linking it to patient-specific detection data.

[0019] DE 10 2013 109 057 A1 discloses a method for planning and preparing a surgical procedure in the human or animal body. At least one implant is to be inserted. An image assistance device displays multidimensional representations of the body based on reference databases.

[0020] Finally, DE 112006003722 B4 discloses a simulation system for surgical interventions in human and veterinary medicine, in which structures are incorporated into an anatomical model that mark permitted and risk areas. In conjunction with the detection of surgical instruments, this allows for the detection of approaching, touching, and infringing prohibited zones. This, in turn, is monitored by an electronic control, measurement, and evaluation unit, which simultaneously assesses the chances of success of a practiced surgical procedure.

[0021] A disadvantage of these documents is that the patient data is stored in external databases separate from the actual training model, requiring time-consuming access before the desired data can be used. Furthermore, these databases contain all the parameters of all recorded patients, requiring the user to first select which data set they want to use for the respective training situation, which is time-consuming and sometimes confusing. Further disadvantages include the time-consuming and sometimes confusing process of updating the entire databases, which also depends on the available internet connection, as well as the potential loss of all data records in the database in the event of a malfunction. This results in ineffective use of these systems.

[0022] It would therefore be highly desirable to provide a training system that allows the user to use it in a user-friendly manner by allowing the user to determine the desired training to be carried out using variably combinable components.

[0023] The object of the invention is therefore to provide a system which overcomes the disadvantages of the prior art.

[0024] The goal is to provide a training system suitable for the validation and training of various surgical procedures in human and veterinary medicine, and one that is individually adapted and trained for this purpose. The individual design of the training system is intended to ensure effective, specialized, and focused training.

[0025] According to the invention, this object is achieved by a system, an anatomical replica of an exchangeable training region, and a method according to the independent claims. Advantageous embodiments are specified in the dependent claims.

[0026] A first aspect of the invention relates to a system for validating and training surgical interventions in human and veterinary medicine, which system comprises a training model anatomically modeled on the human or animal body. The system comprises an anatomical replica of a body part of the human or animal body, which has a recess, and an anatomical replica of an exchangeable training region, which is designed to be inserted into the recess of the anatomical replica of the body part and has a front side that is accessible from the outside and a back side that is positively connected to the recess of the anatomical replica of the body part. Furthermore, the system comprises an optoelectronic detection means.The optoelectronic detection means is arranged in the recess of the anatomical replica of the body part in such a way that it is designed by means of the control, measuring and evaluation unit for recording the surgical interventions as well as for monitoring the positioning of surgical instruments and / or implants on the back of the exchangeable training region.

[0027] The optoelectronic detection system is used to record the processes taking place within the training model and to inform the user in real time about the training success and the positioning of the surgical instruments and / or implants. The surgical field is thus monitored automatically.

[0028] The system also includes an electronic control, measuring and evaluation unit as well as means for signal transmission.

[0029] The system according to the invention is used to evaluate newly developed surgical systems and surgical instruments, and / or implants for the training of surgeons and to test complicated surgical procedures before the actual operation in order to increase the chances of success of a surgical procedure in various surgical disciplines.

[0030] The course and outcome of the surgical procedure are recorded and presented objectively and in real time.

[0031] The training model serves the user, hereinafter also referred to as operator, surgeon or doctor, for the validation and training of surgical procedures in human and veterinary medicine.

[0032] In one embodiment, the system is designed as a simulation system. The system includes a training model. Surgical and minimally invasive surgical techniques are simulated and tested by replicating real anatomical and functional conditions on the patient during a surgical or minimally invasive surgical procedure.

[0033] The training model represents a precise and anatomically accurate replica of a human or animal body.

[0034] According to the invention, the training model comprises the anatomical replica of a body part, an anatomical replica of an exchangeable training region and an optoelectronic detection means.

[0035] According to the invention, the system comprises an anatomical replica of a body part of the human or animal body. The term "anatomical replica of the body part" refers, within the meaning of the invention, to various body parts, all of which are anatomically reproducible. A body part is understood to be a segment of the body that is morphologically recognizable as a functional unit. This includes, for example, the leg, arm, pelvis, head, or spine.

[0036] In one embodiment, the anatomical replica of a patient's body part has various configurations. The correspondingly replicated human or animal body part is anatomically precise and realistically reproduced. The type of configuration of the body part is based on various factors, such as the simulated age of the patient to be examined and / or the corresponding anatomy. In one embodiment, any body part of a human or animal can be represented as an anatomical replica of a body part.

[0037] The size of the anatomical replica of a human body part refers, within the meaning of the invention, to any size of a body part that a human, regardless of whether male or female, can assume over the course of their life. In one embodiment, the size of the body part refers to the reproduced realistic anatomy of an average adult man or an average adult woman. In a further embodiment of the invention, the size of the body part refers to a child and corresponds to the size of the body part of the respective reproduced realistic anatomy of a child. The size of the body part of an animal refers, within the meaning of the invention, to any body part size that an animal, regardless of whether male or female, can assume over the course of its life. In an alternative embodiment of the invention, the size of the body part is smaller or larger than the reproduced realistic anatomy of a human or animal.

[0038] Furthermore, the type of design of the anatomical replica of a body part is based on the course and / or stage of the disease of the patient to be examined.

[0039] In a preferred embodiment, the anatomical replica of the body part is designed as an anatomical replica of a skull, most preferably as an anatomical replica of a human skull.

[0040] According to the invention, the anatomical replica of the body part has a recess. A recess, as defined by the invention, is a recessed space, an opening, or a cavity in the anatomical replica of the body part. The recess can have various dimensions and is adapted to the size of the body part and the interchangeable training region that can be inserted into the recess. The recess in the anatomical replica of the body part corresponds to a space into which at least part of the interchangeable training region can be inserted.

[0041] In one embodiment, the anatomical replica of a body part is designed as a skull, with the recess located in the petrous bone region of the skull. In an alternative embodiment, the recess is located in the nasal bone region of the skull.

[0042] In a further alternative embodiment, the anatomical replica of a body part is designed as an arm, in a special embodiment as a forearm, wherein the recess is located in the area of ​​the radial and ulnar arteries.

[0043] In another alternative embodiment, the anatomical replica of a body part is designed as a back region, with the recess located in the area of ​​the spine. This can depict either the entire spine or just a section, such as the cervical, thoracic, or lumbar spine.

[0044] According to the invention, the system comprises an optoelectronic detection means. In a preferred embodiment, the optoelectronic detection means is arranged in the recess of the anatomical replica of the body part in such a way that it is configured on the back of the interchangeable training region by means of the electronic control, measurement, and evaluation unit for recording the surgical procedures and monitoring the positioning of the surgical instruments and / or implants.

[0045] In one embodiment, the optoelectronic detection device serves to record the processes taking place within the training model and to inform the user in real time about the training success and the positioning of the surgical instruments and / or implants. The surgical field is thus monitored automatically.

[0046] In a preferred embodiment, the optoelectronic detection means is connected to the electronic control, measuring and evaluation unit by means for signal transmission.

[0047] In one embodiment, a feedback signal is sent from the optoelectronic detection means to the electronic control, measuring, and evaluation unit via signal transmission means. In one embodiment, the signal transmission means are electrical cables.

[0048] In a preferred embodiment, the optoelectronic detection means is a recording device, most preferably a digital video camera. In an alternative embodiment, the optoelectronic detection means is a webcam. In a preferred embodiment, the optoelectronic detection means has a CMOS sensor. In an alternative preferred embodiment, the optoelectronic detection means has a CCD sensor, specifically a two-dimensional CCD array sensor.

[0049] In a preferred embodiment, the feedback signal from the optoelectronic detection device mounted in the replaceable training region of the training model is sent to the electronic control, measurement, and evaluation unit and evaluated and analyzed by the computer program product, allowing the training progress to be monitored and assessed in real time. The training duration and the number of injuries are also recorded by the computer program product.

[0050] In one embodiment, the optoelectronic detection means is connected to the electronic control, measuring, and evaluation unit via signal transmission means. In one embodiment, the signal transmission means are electrical cables.

[0051] In one embodiment, the optoelectronic detection means sends a signal, coupled back to the optoelectronic detection means, to the electronic control, measurement, and evaluation unit via the signal transmission means. The transmitted signal contains data about the current training progress. The data includes audiovisual specifications such as image resolution and derived aspect ratio, refresh rate, and color depth.

[0052] In one embodiment, the optoelectronic detection means transmits the recorded data during operation, i.e., during training, to the electronic control, measurement, and evaluation unit. In another embodiment, the optoelectronic detection means transmits the recorded data to the electronic control, measurement, and evaluation unit before or after training.

[0053] Advantageously, the data with the interchangeable training region are thus transferred to the electronic control, measuring and evaluation unit when the interchangeable training region is connected to the anatomical replica of the body part.

[0054] By arranging the optoelectronic detection device in the recess of the anatomical replica of the body part, the surgical procedures and techniques performed during training are advantageously transmitted to the electronic control, measurement, and evaluation unit via the signal transmission device. This ensures monitoring of the positioning of the surgical instruments and / or implants on the back of the interchangeable training region.

[0055] In one embodiment, the risk structures to be examined and / or the anatomical space surrounding the risk structures are designed to be transparent, thus advantageously enabling good visualization for the optoelectronic detection means. In a preferred embodiment, at least areas of the interchangeable training region are designed to be transparent. The term "risk structure" refers to those components in the interchangeable training region of the training model that can be injured during training but should not be injured during use on a living patient.

[0056] In one embodiment, plastics such as polyamides or silicones are used as transparent materials.

[0057] The optoelectronic detection device also advantageously ensures the success of the procedure on the training model, for example, by estimating how far an implant, such as a cochlear implant, can be inserted. The optoelectronic detection device advantageously monitors vulnerable risk structures and thus injuries in the removable training region. Furthermore, the optoelectronic detection device informs the user in real time about the training success. Training success includes, for example, the positioning of the surgical instruments and / or implants, e.g., how far a cochlear implant could be inserted into the removable training region.

[0058] The user is informed in real time about the training progress, which is monitored and assessed, by the feedback signal of the optoelectronic detection device.

[0059] It is advantageous to interrupt the training early if errors occur, thus saving time or allowing the training to be continued or restarted later.

[0060] Errors that occur include, for example, incorrect penetration due to incorrect positioning of the surgical instruments and / or implants at the front of the interchangeable training region, or positioning of the surgical instruments and / or implants at the back of the interchangeable training region, which is located at a different location on the back of the interchangeable training region than required and planned. The number of injuries to functionally important anatomical areas caused by incorrect penetration or positioning of the surgical instruments and / or implants is recorded.

[0061] Furthermore, it includes a holder for the anatomically modeled body part so that it is stable during training and prevents slipping.

[0062] During the procedure, it is advantageous to make statements about potentially damaged risk structures and thus injuries, thus allowing the success of the operation to be monitored. The success monitoring and learning success provide the user with confidence and routine during surgical procedures. Furthermore, the progress of the operation is advantageously evaluated. For example, an assessment is made of the type of positioning of the surgical instruments and / or implants, or how much of the tissue to be removed from the replaceable practice region or the transparent risk structures contained therein, as well as the anatomical space surrounding the risk structures, has been removed.

[0063] According to the invention, the system comprises an anatomical replica of an exchangeable training region.

[0064] The term "interchangeable training region" in the context of the invention refers to a body region that is anatomically topographically and functionally assigned to the corresponding defined anatomical replica of a body part. The interchangeable training region corresponds to the surgical field for the user of the training model, in which they practice surgical procedures. In one embodiment, the training region is interchangeable. The interchangeable training region represents an anatomical replica of a body region. In one embodiment, any body region of a human or animal can be represented as an interchangeable training region.

[0065] According to the invention, the interchangeable training region is designed to be insertable into the recess of the anatomical replica of the body part. In one embodiment, the interchangeable training region is designed to fit snugly into the recess of the anatomical replica of the body part.

[0066] Furthermore, according to the invention, an anatomical replica of an exchangeable training region is designed to be insertable into a holding device. According to the invention, the anatomical replica of an exchangeable training region has a front side that is accessible from the outside and a rear side that is positively connected to the holding device. In one embodiment, the holding device is designed as a technical holder. Advantageously, the anatomical replica of the exchangeable training region can be positively inserted into any conceivable holding device.

[0067] In a preferred embodiment, the anatomical replica of an exchangeable training region, which can be inserted into the holding device, comprises an optoelectronic detection means. In a further preferred embodiment, at least regions of the anatomical replica of an exchangeable training region, which can be inserted into the holding device, are partially transparent. In a further preferred embodiment, the anatomical replica of an exchangeable training region, which can be inserted into the holding device, further comprises a storage medium. In a further preferred embodiment, the anatomical replica of an exchangeable training region, which can be inserted into the holding device, comprises means for signal transmission.

[0068] In a preferred embodiment, the interchangeable training region is detachably connected to the anatomical replica of the body part.

[0069] In a preferred embodiment, the exchangeable training region is designed as a petrous bone, in particular as a precise anatomical replica of the petrous bone region, most preferably as a human petrous bone region, which can be inserted into a skull. In a further embodiment, the exchangeable training region is designed as a precise anatomical replica of the nasal bone region, which can be inserted into a skull. In an alternative embodiment, the exchangeable training region is designed as a precise anatomical replica of an arm segment, in a special embodiment a forearm segment, which can be inserted into the recess in the area of ​​the radial and ulnar arteries. In a further alternative embodiment, the exchangeable training region is designed as a precise anatomical replica of a spinal column segment, which can be inserted into the recess in the dorsal region.Either the entire spine can be shown or just a section such as the cervical, thoracic or lumbar spine.

[0070] The design of the interchangeable exercise region is based on various factors such as the simulated age of the patient and / or the corresponding anatomy.

[0071] The size of the interchangeable training region of a human being refers, within the meaning of the invention, to any size of the interchangeable training region that a human being, regardless of whether male or female, can assume over the course of their life. In one embodiment, the size of the interchangeable training region refers to the simulated realistic anatomy of an average adult man or an average adult woman. In a further embodiment of the invention, the size of the interchangeable training region refers to the simulated realistic anatomy of a child and corresponds to the size of the anatomy of the respective child's age. The size of the interchangeable training region of an animal refers, within the meaning of the invention, to any size of the interchangeable training region that an animal, regardless of whether male or female, can assume over the course of its life.In an alternative embodiment of the invention, the size of the interchangeable training region is smaller or larger than the simulated realistic anatomy of a human or animal.

[0072] Furthermore, the design of the interchangeable exercise region is based on the course and / or stage of the disease of the patient to be examined.

[0073] According to the invention, the replaceable training region has a front side. In one embodiment, the front side represents a surface that faces outward and is exposed. For the purposes of the invention, "outside" refers to the environment of the system from which the user has free access to the training region. Preferably, the front side is accessible to the user from the outside, i.e., the surgical instruments and / or implants are inserted into the replaceable training region through the front side. The front side of the replaceable training region thus represents the access area for the user during training.

[0074] In one embodiment, the interchangeable training region is opened using a surgical procedure using surgical instruments prior to the insertion of surgical instruments and / or implants. This advantageously also allows for training in opening the interchangeable training region prior to, for example, the insertion of an implant. In one embodiment, the interchangeable training region comprises a skin imitation that has different and lifelike thicknesses and mechanical properties, allowing the skin imitation to be realistically cut through using surgical instruments.

[0075] In an alternative embodiment, the front of the interchangeable training region is not in physical contact with the anatomical replica of the body part.

[0076] According to the invention, the replaceable training region further comprises a back side.

[0077] In one embodiment, the back represents a surface which faces inwards, ie towards the anatomical replica of the body part.

[0078] In one embodiment, the back side is at least partially in physical contact with the anatomical replica of the body part. According to the invention, physical contact means a positive connection. In one embodiment, the back side is at least partially in physical contact with the recess of the anatomical replica of the body part. In a preferred embodiment, the back side is at least partially positively connected to the recess of the anatomical replica of the body part. In one embodiment, the back side is in physical contact with the recess of the anatomical replica of the body part.

[0079] In one embodiment, the back of the interchangeable training region is at least partially in physical contact with the anatomical replica of the body part. In one embodiment, the back is not accessible to the user from the outside.

[0080] In one embodiment, the anatomical replica of the body part and / or the interchangeable training region can be produced using additive manufacturing processes based on three-dimensional patient data. For example, the anatomical replica of the body part and / or the interchangeable training region can be produced using a rapid prototyping process. This advantageously also allows for a patient-specific anatomy of the anatomical replica of the body part or the interchangeable training region, allowing each training session to be individually designed and implemented.

[0081] In a preferred embodiment of the invention, the replaceable training region comprises a storage medium. In one embodiment, the replaceable training region comprises a storage medium on the back.

[0082] The storage medium is also referred to as a data storage device. In one embodiment, a semiconductor memory serves as the storage medium. In a preferred embodiment, the storage medium is a memory chip. In one embodiment, the storage medium is designed as a non-volatile data storage device, such as a flash memory.

[0083] In one embodiment, data records are stored on the storage medium. In a preferred embodiment, patient-specific data is stored on the storage medium. In another embodiment, specific parameters for the design of the exchangeable training region are stored on the storage medium.

[0084] The patient-specific data provided advantageously enables a specially adapted training model to the respective anatomy and medical history, thus enabling effective and targeted use of the training model. The specific parameters for the design of the interchangeable exercise region also provide information about the body region to be examined.

[0085] In one embodiment, the patient-specific data stored on the storage medium includes parameters relating to the patient's anatomy, age, previous medical findings, pathogenesis, clinical picture, and existing evidence from imaging procedures such as CT or X-ray images. These serve as templates and for orientation and make the training situation appear as realistic as possible. In one embodiment, the patient-specific data corresponds to the medical record of the respective patient being examined. Advantageously, the surgeon can gain an idea of ​​the upcoming and to be performed training before the training procedure. This makes the procedure to be trained more realistic.

[0086] In a further embodiment, specific parameters relating to the design of the interchangeable training region and thus the body region to be examined are stored on the storage medium. Advantageously, the body region to be examined is thus not only an anatomical replica of the interchangeable training region, but also includes all the specific parameters required (design and geometry of the interchangeable training region) for conducting the training.

[0087] In a preferred embodiment, the storage medium can be written to or overwritten with additional patient-specific data. This is achieved by writing this data additionally to the storage medium and supplementing it, or by overwriting the originally existing patient-specific data. Additional patient-specific data refers to either expanded findings from the same patient or new data from another patient with a different clinical picture, anatomy, and age, which are written and saved completely anew or additionally to the storage medium. This allows the user to continually practice new interventions on the training model. Furthermore, the control electronics of the storage medium can be updated at any time, reducing errors such as manipulation or failures.

[0088] In one embodiment, the storage medium is mechanically detachably connected to the replaceable training region. In a preferred embodiment, the storage medium is detachably arranged in the replaceable training region. In another embodiment, the storage medium is detachably arranged in the rear of the replaceable training region. Advantageously, the storage medium can thus be removed from and reconnected to the replaceable training region to write additional or new patient-specific data, to write additional or new specific parameters for the design of the replaceable training region, or to update the control electronics.

[0089] Due to the detachable arrangement of the storage medium in the exchangeable training region, it is possible to connect different storage media, each containing different patient-specific data and specific parameters for the design of the exchangeable training region, to the exchangeable training region and thus to train different clinical pictures for the same trained anatomical exchangeable training region.

[0090] In one embodiment, the storage medium is mechanically and electrically detachably connected to the anatomical replica of the body part.

[0091] In a preferred embodiment, the storage medium is connected to the electronic control, measuring and evaluation unit by means for signal transmission.

[0092] According to the invention, the interchangeable training region is designed to be insertable into the recess of the anatomical replica of the body part. In one embodiment, the interchangeable training region is designed to be detachable from the recess of the anatomical replica of the body part by a positive fit. In one embodiment, the interchangeable training region is mechanically connected to the anatomical replica of the body part.

[0093] From the anatomical replica of the body part are means for signal transmission, which in turn are connected to the electronic control, measuring and evaluation unit.

[0094] In one embodiment, the signal transmission means are electrical cables. In an alternative embodiment, the signal transmission means are a wireless connection, embodied, for example, as Bluetooth or WLAN.

[0095] The anatomical replica of the body part and the storage medium of the interchangeable training region form a detachable plug connection. This ensures an electrical connection as well as a data connection, especially as a hardware interface.

[0096] In a preferred embodiment, the anatomical replica of the body part is connected to the exchangeable training region, and the storage medium contained in the exchangeable training region, with the patient-specific data provided thereon and the specific parameters for the design of the exchangeable training region, is recognized by the electronic control, measurement, and evaluation unit. This occurs by transmitting and assigning the patient-specific data and the specific parameters for the design of the exchangeable training region to the electronic control, measurement, and evaluation unit via signal transmission means. This ensures data exchange when connecting the storage medium in the exchangeable training region with the anatomical replica of the body part to the electronic control, measurement, and evaluation unit.

[0097] The storage medium thus advantageously avoids time-consuming access to a complete database, such as that described in DE 20 2012 011 452 U1, which contains all patient-specific data and must first be loaded or transmitted. Advantageously, fast and independent access to the patient-specific data and specific parameters of the exchangeable exercise region is ensured, without, for example, the need to update an entire database.

[0098] The patient-specific data and specific parameters for the design of the interchangeable training region contained on the storage medium can be accessed quickly at any time. The system is not dependent on a central database, which can be accessed, for example, via an internet connection, and thus requires a consistently reliable connection. This advantageously allows the training model to be used in locations without an internet connection. Furthermore, the patient-specific data and the specific parameters for the design of the interchangeable training region are not affected, for example, in the event of a system crash, since they are not stored centrally in a database but on the storage media.

[0099] By transmitting and displaying patient-specific data when connecting the interchangeable training region with the anatomical replica of the body part, the patient's specific characteristics (age, anatomy, previous medical history, pathogenesis, clinical picture, existing imaging evidence such as CT or X-ray images) and the surgical procedures the user is required to perform are immediately identified. By simultaneously transmitting and displaying the specific parameters regarding the respective design of the interchangeable training region to be examined when connecting the interchangeable training region with the anatomical replica of the body part, the anatomical replica of the body region is immediately identified.

[0100] In a preferred embodiment, the system comprises surgical instruments. In a preferred embodiment, the provided surgical instruments include various tools from the surgical and minimally invasive surgical field, such as pointing tools, drills, ball tampers, surgical scissors, surgical forceps, suction devices, or medical endoscopes.

[0101] Advantageously, the surgical instruments are positioned by the user exactly at the desired and medically necessary location.

[0102] In one embodiment, the selected and medically necessary surgical instrument(s) is / are positioned on the front side of the interchangeable training region and guided through the interchangeable training region to the back side of the interchangeable training region. The passage and positioning of the surgical instruments on the back side of the interchangeable training region is visible as a puncture site in the skin imitation.

[0103] In one embodiment, the surgical instruments contain a marking containing identifying features and parameters. Advantageously, the marking is designed differently so that the surgical instruments can be distinguished. The marking on the surgical instruments is captured by a detection means such as a camera and forwarded to a computer program product, thereby identifying which surgical instruments are being used during the respective training session. In one embodiment, the detection means also monitors the surgical procedure on the front of the interchangeable training region.

[0104] In one embodiment, any commercially available surgical instrument is suitable for training surgical procedures with the system according to the invention. In one embodiment, the surgical instruments are designed as attachments.

[0105] In one embodiment, the surgical instruments are connected to the electronic control, measurement, and evaluation unit via signal transmission means. In one embodiment, the signal transmission means are electrical cables.

[0106] The surgical instruments are individually adapted to the training to be carried out and can be exchanged depending on the type of training or in the event of repairs.

[0107] In a preferred embodiment, the system comprises implants. In one embodiment, the implants comprise medical implants such as a cochlear implant.

[0108] Advantageously, the implants are positioned by the user exactly at the desired and medically required location.

[0109] In one embodiment, the selected and medically necessary implant(s) is / are positioned on the front side of the replaceable training region and guided through the replaceable training region to the back side of the replaceable training region. The passage and positioning of the implants on the back side of the replaceable training region is visible as a puncture site in the skin imitation.

[0110] In one embodiment, the implants are connected to the electronic control, measurement, and evaluation unit via signal transmission means. In one embodiment, the signal transmission means are electrical cables.

[0111] The implants are individually adapted to the training to be performed and can be conveniently replaced depending on the type of training or in the event of repairs.

[0112] In a preferred embodiment, the system comprises an electronic control, measurement, and evaluation unit. The electronic control, measurement, and evaluation unit ensures a virtual and / or realistic representation of the examination in the surgical field during training on the training model.

[0113] In a preferred embodiment, the system comprises signal transmission means. The electronic control, measurement, and evaluation unit is connected to signal transmission means. This enables automated monitoring of the interchangeable training region and the surgical field during operation, i.e., during training. In one embodiment, the signal transmission means are electrical cables.

[0114] A virtual representation is defined as a three-dimensional reproduction of the training process in the surgical field of the interchangeable training region, generated by the computer program product. Medical images stored on the storage medium serve as the basis for the virtual representation generated by the computer program product.

[0115] A realistic representation is understood to mean a visual reproduction of the training process in the surgical field of the interchangeable training region, which is transmitted in real time as a video image, for example, by an optoelectronic detection device.

[0116] The virtual and / or realistic representation of the surgical field is transmitted to the electronic control, measuring and evaluation unit, while the user simultaneously interacts with the underlying training model.

[0117] In one embodiment, the electronic control, measuring and evaluation unit is a computer.

[0118] In one embodiment, the electronic control, measuring and evaluation unit further comprises a computer program product which provides for the virtual and / or realistic representation of the surgical field and training process.

[0119] In one embodiment, the surgical scenarios to be learned can be studied using procedural protocols. The procedural protocols define parameters that provide information about the quality of the practiced procedure and thus (in the case of multiple tests) about the learning success as a measure of success. These parameters include, for example, the duration of the procedure, economy of hand movement, and injury to functionally important anatomical areas.

[0120] In one embodiment, the computer program product further recognizes the surgical instruments and / or implants used during training based on the markings attached to them and calibrates them accordingly for the respective training situation. Thus, the training and the training process are controlled and monitored on the training model.

[0121] In one embodiment, the surgical instruments are calibrated to determine the axial lengths and tip location of the surgical instruments. Furthermore, a directional calibration is performed to determine the orientation of the surgical instruments within the virtual and / or realistic representation of the surgical field.

[0122] In a further embodiment, the computer program product recognizes the correspondingly used interchangeable training region with the specific parameters contained on its storage medium for designing the interchangeable training region as well as patient-specific data when connecting the interchangeable training region with the anatomical replica of the body part.

[0123] In a further embodiment, a patient calibration can be carried out in which the coordinate system generated in the virtual and / or realistic representation of the interchangeable training region located in the recess of the anatomical replica of the body part is aligned with the coordinate system of the surgical instruments.

[0124] In a preferred embodiment, the feedback signal from the optoelectronic detection device mounted in the replaceable training region of the training model is sent to the electronic control, measurement, and evaluation unit and evaluated and analyzed by the computer program product, allowing the training progress to be monitored and assessed in real time. The training duration and the number of injuries are also recorded by the computer program product.

[0125] In a preferred embodiment, the system and method according to the invention are used for validating and training surgical procedures in human and veterinary medicine. In one embodiment, the system is intended for trainees, specialists, trainees, or system testers to practice with. In another embodiment, the system is intended for companies that employ, use, and / or demonstrate the use of their own surgical instruments and / or implants.

[0126] The surgical procedures include surgical and minimally invasive surgical procedures.

[0127] The surgical procedures are carried out using the surgical instruments and / or implants provided.

[0128] The surgical procedures to be trained include, for example, the removal of bone, the insertion of medical implants, the setting of medical screws, the creation of access, the removal of tissue such as tumors and the creation of surgical access to the diseased regions.

[0129] The surgical procedures to be trained also include minimally invasive methods such as medical endoscopy, minimally invasive spinal surgery (including decompression of spinal cord areas and fusion of vertebrae after herniated discs), the placement of implants and the removal of tumors and / or bone adhesions.

[0130] The system according to the invention advantageously enables effective training for the user. The optoelectronic detection system allows the training to be monitored in real time. The customized anatomical design and the patient-specific data stored on the storage medium allow the user to focus on an individual and specific problem.

[0131] Advantageously, the training model includes interchangeable components such as flushable, bone-like material and pneumatized bones.

[0132] Typical surgical procedures to be practiced in the petrous bone region include training in mastoidectomy and cochleostomy as well as the placement of implants such as middle and inner ear implants.

[0133] The artificial sinus patients primarily enable training in skull base surgery and functional endoscopic sinus surgery (FESS), in which the opening of the paranasal sinuses and the removal of tumors (pituitary tumors) or polyps are among the frequently practiced procedures.

[0134] In spinal surgery, training-intensive procedures are very common, especially in operations on intervertebral discs during decompression or in the fixation of vertebral bodies (e.g., after a fracture). Furthermore, minimally invasive surgical techniques and manual skills such as the insertion of pedicle screws and intervertebral implants (cages), as well as vertebral fusion, can be learned using the training model.

[0135] The use of the training model validates the quality and learning outcome of the surgical procedures. This success control immediately informs the user whether risk structures were damaged or whether the operation proceeded without disruption.

[0136] In embodiments of the invention, the components of the training model are designed to be reusable.

[0137] Depending on the type of training being performed, all or some components of the training model are reusable. After training, the interchangeable training region is removed from the anatomical replica of the body part, and both components are cleaned separately. The anatomical replica of the body part is removed from the holder, and the holder for the anatomical replica of the body part is also cleaned. Furthermore, the surgical instruments used are cleaned.

[0138] For the realization of the invention, it is also expedient to combine the above-described inventive embodiments, embodiments and features of the claims in each arrangement.

[0139] The invention will be explained in more detail below using several exemplary embodiments. These exemplary embodiments are intended to describe the invention without limiting it.

[0140] The invention is applicable to almost all areas of human and veterinary medicine. The invention is explained in more detail with the aid of drawings. Fig. 1 an anatomical replica of a skull with replaceable petrous bone region and optoelectronic detection means, Fig. 2 a detailed view of the anatomical replica of a skull with replaceable petrous bone region and optoelectronic detection means, Fig. 3 a detailed view of the replaceable petrous bone region with optoelectronic detection means, Fig. 4 an replaceable petrous bone region with storage medium and connections for the means for signal transmission to the electronic control, measuring and evaluation unit, Fig. 5 the replaceable petrous bone region from Fig. 4 in a side view, Fig. 6 an exchangeable nose region from the side in an exploded view with storage medium and connections for the means for signal transmission to the electronic control, measuring and evaluation unit, Fig. 7 the exchangeable nose region from Fig. 6in a front view, Fig. 8 an anatomical replica of a skull with interchangeable nasal region and storage medium as well as connections for the means of signal transmission to the electronic control, measuring and evaluation unit.

[0141] The first embodiment relates to the temporal bone region and thus to a limited area within the scope of ENT specialists. The training model is used for the implantation of a cochlear implant electrode and includes an anatomical replica of a human skull, into whose recess an anatomically shaped and replaceable temporal bone region can be inserted. The temporal bone region is precisely connected to the skull.

[0142] The petrous bone region encompasses a section of the temporal bone (os temporale) and surrounds the inner ear (labyrinth). The tympanic part (surrounding the middle ear) and mastoid part of the temporal bone also belong to the petrous bone region. The cochlea with the scala tympani and semicircular canals, as well as (movable) auditory ossicles, are also part of the petrous bone region. The soft tissue, such as the replica of the dura, is molded from silicone. The petrous bone region also includes a replica of the eardrum, as well as muscles and nerves such as the nervus dacialis, chorda typani, and stapedius muscle. Blood vessels such as the jugular vein and carotid artery are also replicated.

[0143] The facial nerve and the tympanic nerve, among others, pass through the petrous bone region. On the anterior surface (in animals, the inner surface) of the petrous bone region lies a shallow fossa for the trigeminal ganglion. The petrous bone region has three important entrances: the internal auditory opening (porus acusticus internus), where the facial nerve enters and the vestibulocochlear nerve exits; the stylomastoid foramen, where the facial nerve exits; and the musculotubar canal, the canal of the auditory tube (tuba auditoriva) into the middle ear. Furthermore, a petrotympanic fissure between the petrous bone region and the tympanic part of the temporal bone serves as the exit point for the chorda tympani. In some mammals (e.g. humans, horses, cattle) the hyoid bone is ligamentously attached to the styloid process of the petrous bone.

[0144] The petrous bone region has an anterior side, which is freely accessible to the surgeon from the outside, and a posterior side. The posterior side of the petrous bone region is at least partially in physical contact with the anatomical replica of the skull.

[0145] Figure 1 shows an overview sketch of the system 1 according to the invention. The temporal bone region is shown as the interchangeable training region 2. This is a sensitively detected structure, positively inserted into the anatomical replica of a body part 3, here a human skull. An optoelectronic detection means 4, here a digital video camera, is connected to the interchangeable training region 2 and an electronic control, measuring, and evaluation unit 5 (not shown) via signal transmission means 7 (not shown).

[0146] A (video) digital camera (not shown) is arranged in the recess of the skull so that the surgical procedure is recorded by a computer (not shown) and furthermore the positioning of the surgical instruments and / or the implants (not shown) is monitored by the computer (not shown) at the back of the petrous bone region.

[0147] An SSD card serves as the storage medium (not shown). The SSD card is attached to the back of the replaceable temporal bone.

[0148] All processes taking place are displayed on a monitor (not shown). The digital (video) camera sends a feedback signal to the computer (not shown).

[0149] Figure 2shows a detailed view of the system 1 of the anatomical replica of a skull 3 with a form-fitting, replaceable region of the petrous bone of the inner ear 2 as a sensitively detected ("glass") structure as well as an optoelectronic detection means 4.

[0150] Figure 3 shows a single view of the petrous bone region of the inner ear 2 as a sensitively detected structure with an exposed optoelectronic detection means 4.

[0151] In a spinal model as a second embodiment, a needle is used as a surgical instrument to puncture a replica of the back (not shown). The spine, which serves as an interchangeable training region with its memory chip containing patient-specific data, is then used to practice tapping a nerve.

[0152] Figure 4shows the replaceable training region 2 with storage medium 5 and connectors 6 for the means for signal transmission to the electronic control, measurement, and evaluation unit. The temporal bone region is shown as the replaceable training region 2. A storage medium 5, here an SSD card, is detachably arranged in the rear of the replaceable training region 2. Furthermore, connectors 6 for the means for signal transmission to the electronic control, measurement, and evaluation unit (not shown) are attached to the rear of the replaceable training region 2.

[0153] A digital video camera (not shown) is positioned in the skull recess (not shown) so that the surgical procedure is recorded by a computer, and the positioning of the surgical instruments and / or implants at the posterior aspect of the temporal bone is monitored by the computer. All processes taking place are displayed on a monitor (not shown). The digital video camera (not shown) sends a feedback signal to the computer (not shown).

[0154] Figure 5 shows the interchangeable petrous bone region 2 from Fig. 4from the side. Here, too, the SSD card can be seen as storage medium 5, which is detachably arranged in the back of the replaceable petrous bone region 2. Furthermore, the connections 6 for the means of signal transmission to the electronic control, measurement, and evaluation unit (not shown) can be seen on the back of the replaceable petrous bone region 2.

[0155] In a nasal model of the nasal region, as a second embodiment, the ethmoid cells are opened using various instruments, endoscopes, and medical devices. The memory chip of the interchangeable training region can contain, for example, patient information such as age, medical history, patient anatomy, and the artificial patient's behavior in the event of injury to a risk structure. Furthermore, suggestions for the further course of the operation can be read from the memory chip.

[0156] Figure 6shows a second exemplary embodiment of an interchangeable training region 2, representing the nasal region, from the side. Also shown in the exploded diagram is the storage medium 5, which is designed as an SSD card, as well as connectors 6 for the means for signal transmission to the electronic control, measurement, and evaluation unit (not shown), which are represented as pins.

[0157] Figure 7 shows the interchangeable nose region 2 from Fig. 6 in a front view, now with a detachably inserted SSD card as storage medium 5.

[0158] Figure 8shows an overview diagram of the system 1 according to the invention. The temporal bone region is shown as the interchangeable training region 2. This can be inserted as a sensitively detected structure in the anatomical replica of a body part 3, here a human skull, in a form-fitting manner. An SSD card as a storage medium 5 and connections for the means of signal transmission (not shown) to the electronic control, measurement, and evaluation unit (not shown) are shown in exploded diagram form and are detachably inserted into the interchangeable nasal region 2.

[0159] In a spinal model, a third embodiment, a needle is used as a surgical instrument to puncture a replica of the back (not shown). The spine, which serves as an interchangeable training region with its memory chip containing patient-specific data, is then used to practice tapping a nerve. Reference symbol

[0160] 1System for validating and training surgical interventions in human and veterinary medicine 2Interchangeable training region 3Anatomical replica of a body part 4Optoelectronic detection device 5Storage medium 6Connections for the means of signal transmission to the electronic control, measurement, and evaluation unit

Claims

1. System for the validation and training of surgical interventions in human and veterinary medicine (1), which has a training model anatomically modelled on the human or animal body, comprising - an anatomical replica of a body part (3) of the human or animal body, which has a recess, - an anatomical replica of an exchangeable training region (2), which is designed to be insertable into the recess of the anatomical replica of the body part (3), and which: - has a front side, which is accessible from the outside, and - has a rear side, which is at least partially positively connected to the recess of the anatomical replica of the body part (3), wherein the rear side corresponds to the surgical field for a user of the training model in which he practices surgical interventions and is not accessible to the user from the outside, and - an optoelectronic detection means (4), characterized in that the optoelectronic detection means (4) is arranged in the recess of the anatomical replica of the body part (3) in such a way that it is designed to detect the surgical interventions and to monitor the positioning of surgical instruments and / or implants at the rear of the exchangeable training region (2).

2. System (1) according to claim 1, characterized in that the recording of the surgical interventions and the monitoring of the positioning of the surgical instruments and / or the implants at the rear of the exchangeable training region (2) is realized by an electronic control, measurement and evaluation unit.

3. System (1) according to claim 1 or 2, characterized in that it comprises means for signal transmission.

4. System (1) according to one of claims 1 to 3, characterized in that the optoelectronic detection means (4) is a video digital camera with a CMOS sensor or a CCD sensor.

5. System (1) according to one of claims 1 to 4, characterized in that at least areas of the exchangeable training region (2) are transparent.

6. System (1) according to one of claims 1 to 5, characterized in that the exchangeable training region (2) has a storage medium (5) on which patient-specific data is stored and which is writable or overwritable with further patient-specific data, the storage medium (5) being detachably arranged in the exchangeable training region (2).

7. System (1) according to one of claims 1 to 6, characterized in that the optoelectronic detection means (4) and / or the storage medium (5) is connected to the control, measurement and evaluation unit by means for signal transmission.

8. System (1) according to one of claims 1 to 7, characterized in that the exchangeable training region (2) is detachably connected to the anatomical replica of the body part (3).

9. Anatomical replica of an exchangeable training region (2), which is designed to be insertable into a recess of an anatomical replica of a body part (3), characterized in that it is designed to be insertable into a holding device, and which: - has a front side which is accessible from the outside, and - has a rear side which is positively connected to the holding device, wherein the rear side corresponds to the surgical field for a user of the training model, in which he practices surgical interventions, and is not accessible to the user from the outside, wherein the exchangeable training region (2) corresponds to the surgical field, comprises an optoelectronic detection means (4) and a storage medium (5) and at least areas of the exchangeable training region (2) are partially transparent, wherein the optoelectronic detection means (4) is arranged in the recess of the anatomical replica of the body part (3) in such a way that it is designed to detect the surgical interventions and to monitor the positioning of surgical instruments and / or implants on the rear side of the exchangeable training region (2), wherein the holding device is designed as a technical holder.

10. Anatomical replica of an exchangeable training region (2) according to claim 9, characterized in that it comprises means for signal transmission.

11. Method for validation and training of surgical interventions in human and veterinary medicine with a system according to any one of claims 1 to 8, comprising the training model anatomically simulating the human or animal body, characterized in that the optoelectronic detection means (4) mounted in the exchangeable training region (2) of the training model transmits a feedback signal to the control, measurement and evaluation unit, the transmitted signal containing data on the current training progress comprising audiovisual specifications such as image resolution and derived aspect ratio, frame rate and colour depth.

12. Method according to claim 11, characterized in that the training progress is monitored and assessed in real time through the feedback signal of the optoelectronic detection means (4).

13. Method according to one of claims 11 or 12, characterized in that the anatomical replica of the body part (3) is connected to the exchangeable training region (2) and the storage medium (5) contained in the exchangeable training region (2) is detected by the electronic control, measurement and evaluation unit by means for signal transmission.

14. Use of a system (1) according to any one of claims 1 to 8, of an anatomical replica of an exchangeable training region (2) according to any one of claims 9 or 10 and / or a method according to any one of claims 11 to 13 for validation and / or training of surgical interventions in human and veterinary medicine.