Therapy system and method for treating a flat body region of a living being with therapeutically effective waves

Abstract

The invention relates to a therapy system (58) for non-surgical treatment of at least one flat body region (10) of a living being, comprising an applicator unit (12), having a therapy head (14) for applying propagating physical therapeutically active waves to the planar body region (10), and a tracking system (16) that is provided to determine instantaneous 3D position data (30, 32) of the applicator unit (12) during a plurality of treatment steps (18, 20) of the treatment of the flat body region (10). According to the invention, the therapy system (58) has a computing unit (22) with access to a 3D output model (26) of a body part (28) of a living being, the computing unit (22) being provided to receive the 3D position data (30, 32) of the applicator unit (12) detected by the tracking system (16) and, on the basis of the received 3D position data (30, 32), to calculate a surface approximation (34) of the body part (28) proceeding from the 3D output model (26) with the flat body region (10) subjected to the treatment, and to assign surface points (36, 38) of the surface approximation (34) to the 3D position data (30, 32) associated with individual treatment phases (18, 20) of the treatment.

Description

[0001] Therapy system and procedure for treating a large area of ​​a living being's body with therapeutically effective waves

[0002] State of the art

[0003] The invention relates to a therapy system according to the preamble of claim 1 and a method according to the preamble of claim 42.

[0004] Therapy systems for treating large areas of the body of living beings have already been proposed. These systems consist of an applicator unit comprising a therapy head for applying propagating, therapeutically effective physical waves to the affected area and a tracking system designed to determine instantaneous 3D position data of the applicator unit during several treatment phases. However, the known therapy systems use either identical standard organism models for all treated organisms of the same species or actual, precise image and / or model data specific to each treated organism for the digital positioning, display, or documentation of the applicator unit's 3D position data. This data must first be generated using complex methods such as CT scans or other techniques for the precise measurement of living beings.The first approach allows only a relatively imprecise, generalized representation, which does not permit precise treatment of specific body parts or exact comparisons of treatments performed at different times. The second approach involves a significant time commitment for both the patient and the practitioner, as well as considerable equipment requirements, both of which can result in high costs.

[0005] The object of the invention is, in particular, to provide a generic device with advantageous properties for precise and efficient treatment of specific body parts. This object is achieved according to the invention by the features of the independent and dependent claims, while advantageous embodiments and further developments of the invention can be found in the dependent claims.

[0006] Advantages of the invention

[0007] The invention relates to a therapy system for a non-invasive, non-surgical treatment of at least one planar body area of ​​a living being, comprising an applicator unit, preferably manually and / or robotically controllable, comprising a therapy head for applying propagating physical therapeutically effective waves, in particular pressure waves, preferably shock waves, to the planar body area, and comprising a tracking system which is at least intended to determine instantaneous 3D position data of the applicator unit, in particular of the therapy head of the applicator unit, during several treatment phases of the treatment of the planar body area.

[0008] It is proposed that the therapy system comprise a computing unit with access to a storage unit in which at least one 3D output model of a body part of a living being, in particular of a species at least similar to the being to be treated, is stored, wherein the computing unit is designed to receive the 3D position data of the applicator unit acquired by the tracking system, and, based on the received 3D position data, to calculate a surface approximation of the body part with the treated area of ​​the body, derived from the 3D output model and, in particular, deviating at least locally from the 3D output model, and to assign the 3D position data associated with individual treatment sections of the treatment, in particular application sites where the physically therapeutic waves are / were applied to the treated area of ​​the body, to surface points of the surface approximation.This allows for a particularly precise, even millimeter-accurate, and efficient determination and recording of treatment positions on the actual treated area of ​​the organism's body, eliminating the need for prior, complex, and precise body measurements such as CT scans. This significantly reduces treatment costs and times. Compared to using a standard model that applies to all organisms of the same species, this method achieves considerably greater accuracy in determining and recording treatment positions. Furthermore, it allows for a simple and efficient, highly accurate, individualized representation of the treated area. Finally, it enables a simple yet precise allocation of treatment points where the therapeutically effective waves act upon the organism.This approach offers the advantage of improved comparability between repeated measurements, particularly when compared to using a standard organism model. Furthermore, the assignment of 3D position data to surface points of the body part's surface approximation is insensitive to slight translational shifts. Finally, it is advantageous that no markers or physical reference points are required on the organism being treated.

[0009] Non-surgical treatment requires no surgical intervention on the body of the being treated, in particular no incisions in skin or tissue and no other surgical manipulation. Non-invasive treatment specifically requires no injury to the body of the being treated. However, it is conceivable that treatment could be performed using the therapy system in non-invasively opened natural body orifices, such as the vagina, anus, pharynx, esophagus, etc. The applicator unit is preferably intended for use on an external body surface. However, use of the applicator unit inside a body orifice could also be conceivable and possible. The flat body surface is defined in particular by an external body surface, such as a flat area of ​​skin or a flat wound area.However, it is also conceivable that the planar body area is formed by the surface of the interior of a body opening. The living being is preferably a human, but could also be an animal, particularly a mammal, for example, belonging to one of the species horse, dog, cat, cattle, pig, sheep, goat, etc.

[0010] The applicator unit can be handheld or equipped with a manipulable stand that rests on a floor but allows manual repositioning of the applicator unit's therapy head via joints, etc. Alternatively, the applicator unit could be robot-held, so that the movements of the applicator unit's therapy head are at least partially robot-controlled. The therapy head is preferably arranged at a free (axial) end of the applicator unit. The applicator unit preferably comprises a wave generation unit, more preferably a shock wave generation unit. The wave generation unit is specifically designed to generate propagating, therapeutically effective physical waves, particularly pressure waves, preferably shock waves.The wave generation unit can be integrated with the therapy head, so that the therapeutically effective physical waves are generated directly within the therapy head, i.e., very close to the application site. These therapeutically effective physical waves emerge from the therapy head and propagate directly into the body of the treated organism, either directly or via an adapter, such as a membrane or a silicone component, and / or via an application medium, such as an ultrasound gel. Alternatively, instead of generating the therapeutically effective waves within the therapy head, they can also be generated elsewhere and transmitted to the therapy head for application via a transmission element of the applicator unit. The therapy head specifically includes an application area. The therapeutically effective physical waves can preferably be emitted externally via this application area.The application area is preferably designed to make contact with the surface of the flat area of ​​the body to be treated. The application area is, in particular, a body contact area of ​​the therapy head. "Designed" and / or "equipped" should be understood to mean specifically programmed, designed, and / or equipped.

[0011] The fact that an object is intended and / or set up for a specific function shall be understood in particular to mean that the object fulfills and / or performs this specific function in at least one application and / or operating state.

[0012] The tracking system is specifically designed to determine 3D position data within a treatment room and / or relative to a reference point / fixed point. The reference point can be a fixed point in the room or the starting position and orientation of the applicator unit at the beginning of a treatment. Alternatively, the reference point can be set by a user, for example, by touching a point, pressing a start button, or by applying one of the therapeutically effective physical waves for the first time, etc. The tracking system can continuously and / or regularly determine the current 3D position data of the applicator unit.Alternatively or additionally, the tracking system can be designed to determine the current 3D position data of the applicator unit upon request (button press) and / or (only) with each application of one of the physical therapeutically effective waves and / or (only) upon detection of contact of the therapy head with the flat body area.

[0013] A "computing unit" is understood to be, in particular, a unit with information input, information processing, and information output. Advantageously, the computing unit includes at least a processor, memory (especially the storage unit), input and output devices, other electrical components, an operating program, control routines, and / or calculation routines. The components of the computing unit can be arranged on a common circuit board and / or in a common housing. Alternatively, the computing unit can also be designed as a distributed computing infrastructure, e.g., as a cloud computing system. The computing unit can be fully or partially integrated into the application unit. The computing unit can be fully or partially separate from the application unit.In this case, the computing unit or the external part of the computing unit can be connected to the applicator unit, in particular to electronic components of the applicator unit, via a wired (data) connection or a wireless (data) connection. The external part of the computing unit can be a dedicated server or server system, or a cloud computing network.

[0014] The initial 3D model of the body part, particularly during the first treatment of an organism, differs from an exact, current, organism-specific 3D model. The initial 3D model could be a standard 3D model of the body part. Alternatively, the initial 3D model could be a surface approximation from a previous treatment of the same organism. In this case, a new surface approximation would be created based on the previous surface approximation, with the new surface approximation then taking into account / capturing changes to the body part that have occurred in the meantime. The processing unit is specifically designed to shift spatial points of the 3D position data along the shortest distance to the surface approximation when assigning the 3D position data to the surface points of the surface approximation.As an alternative to the shortest distance, the same direction could always be chosen for the displacement (e.g., a perpendicular to the same midplane). Alternatively, a projection for the surface approximation could be made along an orientation of the applicator unit (using 3D orientations of the applicator unit determined simultaneously with the 3D position data) or in a direction of the greatest mean deviation of the midplane of a respective side (e.g., when a knee is moved translationally in one direction). The surface approximation generated by the processing unit represents, in particular, a three-dimensional shape of a real surface of the planar body area, preferably with millimeter accuracy.The assignment of 3D position data from individual treatment sections, particularly application points where the therapeutically effective physical waves are / were applied to the flat body area, to precise surface points of the surface approximation advantageously generates a kind of treatment map in which precise application points within the flat body area are recorded three-dimensionally. In particular, the 3D position data belonging to the individual treatment sections, which are assigned to the surface points of the surface approximation, form approximated 3D surface data.

[0015] Furthermore, it is proposed that the tracking system be designed to determine the 3D positional data for the stationary reference point, which is not necessarily in a fixed relative relationship to the organism being treated. This advantageously eliminates the need for a physical reference marker or a reference object attached to the organism. This significantly improves the comfort of the organism being treated. In addition, it advantageously avoids the time required for creating reference objects.

[0016] Furthermore, it is proposed that the tracking system include at least one tracking element, which is integrated into the applicator unit or attached externally to the applicator unit. A geometric relationship between the tracking element and the therapy head, required for converting the tracking element's localization measurement data into corresponding 3D position data, is programmed into the processing unit or stored on the processing unit's memory. This advantageously allows for precise position determination. The locations of treatment segments can be determined with great advantage.The 3D position data determined by the tracking system, or at least a part of the 3D position data determined by the tracking system, in particular at least the 3D position data of the tracking system belonging to individual treatment sections of the treatment, are in each case the (spatial) coordinates at which the physically therapeutically effective waves are emitted by the therapy head and / or at which the therapy head is attached to / placed on the flat body area.

[0017] Furthermore, it is proposed that, in addition to determining the 3D position data, the tracking system be designed to determine the 3D orientations of the applicator unit, particularly the therapy head, during the multiple treatment phases of the treatment of the flat body area, and preferably to assign these orientations to the respective surface points of the surface approximation. This advantageously allows for the creation of a particularly accurate treatment map for each treatment of a flat body area, based on the surface approximation, which also includes the directions of action of the therapeutically effective physical waves, especially shock waves. Moreover, the surface approximation, and in particular the surface profile of the surface approximation, can be advantageously optimized.The 3D orientation could be determined, for example, using an inertial measurement unit (IMU), an optical sensor, or another suitable sensor. It is conceivable that the same measurement basis could be used to determine both the 3D position data and the 3D orientations. It is also conceivable that the 3D position data, using the acquired 3D orientations, could be transferred to the surface approximation in the corresponding directions, thereby forming the approximated 3D surface data.

[0018] Additionally, it is proposed that the applicator unit be designed to store settings of the applicator unit and / or parameters of the emitted physical therapeutically effective waves, in particular shock wave parameters, preferably 3D printed distributions of shock waves at a depth below the planar body area or in a plane of the planar body area, during the multiple treatment phases of the treatment of the planar body area and to assign them to the respective surface points of the surface approximation.This allows for the advantageous creation of a particularly precise treatment map for each treatment of a flat body area, based on the surface approximation. This map also includes (cumulative) intensity levels of the therapeutically effective physical waves, especially shock waves, preferably at various depths beneath the flat body area and / or beneath the surface approximation corresponding to the flat body area. This also facilitates improved comparison of treatments performed sequentially. Specifically, the settings of the applicator unit and / or the parameters of the therapeutically effective physical waves are settings that are either manually configured by a user on the applicator unit or automatically selected by the therapy system. The applicator unit settings can include focus settings, pulse rate settings, and intensity settings (e.g.,...).The parameters of the physically therapeutic waves can include focus, pulse rate, pressure amplitude, electromagnetic field strength, penetration depth, energy, energy flux density, type or serial number, or other characteristics (e.g., number of pulses delivered by the applicator) of the wave-generating applicator. If the tracking system includes at least one electromagnetic tracking device, real-time tracking with high accuracy can be advantageously achieved. An electromagnetic tracking device advantageously does not require direct line of sight. An electromagnetic tracking device is advantageously independent of lighting conditions. Electromagnetic tracking devices can be designed to be compact and lightweight.In particular, the electromagnetic tracking device comprises a base station that generates an electromagnetic wave field with characteristic frequencies, a characteristic spatial field pattern, and / or characteristic signal structures. The base station could be designed and arranged separately from the applicator unit. The electromagnetic tracking device also includes a receiver that detects the electromagnetic field. The receiver could be integrated into the applicator unit or attached to it. In a manner known to those skilled in the art, the position and / or orientation of the receiver, and thus of the applicator unit, can then be determined from an analysis of the electromagnetic field detected by the receiver. The tracking system may comprise only the electromagnetic tracking device or may also include further tracking sensors / tracking systems in addition to the electromagnetic tracking device.

[0019] Furthermore, it is proposed that the tracking system includes at least one angle encoder integrated into a multi-axis bearing arm or robot arm of the applicator unit, or be designed as a multi-axis bearing arm or robot arm of the applicator unit with an integrated angle encoder, or as a tethered tracking system, for example, a wired fiber optic tracking system. This advantageously enables simple and accurate tracking of the treatment head. Advantageously, a stable reference point can be established. Advantageously, the tracking system can be located outside the applicator unit. The robot arm can be driven, in particular, by automated robotic control. The robot arm is preferably part of a handling robot for moving the applicator unit.The robot arm's tracking system, in particular the angle encoder(s), is specifically designed to evaluate automatically generated movements of the applicator unit, which produce deflections of the robot arm's axes of movement, and to determine the current positions of the applicator unit and thus also of the therapy head. The bearing arm is specifically not motorized or automatically driven. The bearing arm is preferably only manually manipulatorable. The tracking system of the bearing arm, in particular the angle encoder(s), is specifically designed to evaluate manually generated movements of the applicator unit, which produce deflections of the bearing axes of the bearing arm, and to determine the current positions of the applicator unit and thus also of the therapy head.

[0020] The position of the applicator head could also be determined using a wired tracking system. Examples include fiber optic sensor systems or wired fiber optic tracking systems. In such systems, a connecting cable to the applicator unit preferably includes at least one optical fiber. Laser light or broadband light is preferably coupled into this optical fiber. The optical fiber can, for example, be equipped with fiber Bragg gratings to measure deflections of the optical fibers over a distance or at a point relative to a reference point. In principle, information about the deflection, and thus the position of the optical fibers, can be obtained by measuring the intensities, wavelengths, phases, polarizations, and propagation times (reflection at impedance discontinuities).In addition to the position of a cable end of the connecting cable, which is located particularly at or within the applicator unit, the shape of the connecting cable can also be detected. This information could then be used for even more precise positioning or to determine the orientation or angular position of the applicator unit. Fiber optic systems are already used for minimally invasive surgical devices, especially for end-effector tracking. Furthermore, they are already being considered for robot position tracking (e.g., in collapsed buildings, during mine shaft searches and / or mine rescue). The position tracking of instruments or tools tethered via tether is also a subject of research in space exploration. The wired tracking system can also be designed to use other sensors to measure deflections along the connecting cable.Determining the position of the cable end, for example by measuring pressures, forces, or moments, or even mechanical waves, is possible. Wired tracking systems are also conceivable that determine the angular positions between individual cable sections, which can also be rigid, for example, using a fiber optic system. All of the aforementioned and similar or future technologies in this field are subsumed under "wired tracking systems." Therefore, the tracking system of the invention could also be a wired tracking system to record the instantaneous positions of the applicator unit and thus also of the therapy head.

[0021] Furthermore, it is proposed that the therapy system include an EMP protection device designed to protect at least one electromagnetic sensor (EM sensor) of a component of the therapy system, particularly the electromagnetic tracking device, from the (negative) effects of electromagnetic pulses (EMPs), which can occur especially during the generation of the therapeutically effective waves. Electromagnetic pulses can be generated in electrohydraulic shock wave devices during electrical discharges with voltages in the range of 1-1 0V or 1-25 kV. High voltage peaks, also in the range of 1-1 0V or 1-25 kV, can occur in electromagnetic and piezoelectric shock wave devices. This advantageously ensures a high level of operational reliability and prevents malfunctions or damage caused by EMPs.

[0022] In particular, the EMP protection device is designed to implement one or more of the following measures: a) the EM sensor operates discontinuously, measuring only between EMPs, e.g., between two successive EMPs; b) the EM sensor is switched off during the EMP; c) the EM sensor is reset after a spark discharge and before a measurement; d) position data from previous time intervals are used to compensate for any disturbances in the position detection of an EM sensor caused by an EMP; e) at least two EM sensors are used so that the malfunction of one EM sensor caused by an EMP can be compensated for by the other EM sensor; f) the EM sensor is enclosed by a Faraday cage, e.g.,made of copper or aluminum, protected against EMP, g) The EM sensor uses EMP filters, overvoltage protection, EMP-resistant antennas and / or EMP-resistant radio modules, h) Frequency ranges are used for the electromagnetic tracking device that are little or not at all affected by the EMP, and / or i) The EM sensor determines positions at a low frequency in the range of 1-20 Hz. Alternatively or additionally, other EMP protection measures known in the prior art are also conceivable for use as EMP protection for the component of the therapy system containing the EM sensor, in particular the electromagnetic tracking device.

[0023] Furthermore, it is proposed that the tracking system includes a marker mounted on or attached to the applicator unit, which can be detected and tracked by an optical sensor device, such as a camera system with one or more cameras or a laser scanner system with one or more laser scanners, etc., in particular an optical recording device. This advantageously enables particularly simple and continuous position tracking of the applicator unit, which in particular allows for a very compact and lightweight design of the applicator unit.The optical marker can be a pattern marker, in particular with one or more patterns reliably detectable by the optical sensor device; a color marker, in particular with one or more colors reliably detectable by the optical sensor device; a reflective marker, in particular with one or more reflective surfaces reliably detectable by the optical sensor device; or an infrared marker, in particular with one or more infrared-reflecting surfaces reliably detectable by the optical sensor device. The tracking system also includes the optical sensor device. Preferably, the optical sensor device is arranged externally to the applicator unit. Preferably, the optical sensor device is permanently installed and calibrated / measured in a specific area.It is also conceivable that the optical sensor device has an automatic adjustment function by means of which it can adjust itself. Corresponding optical or stereo-optical tracking systems are known to those skilled in the art. In particular, the optical sensor device is designed for the detection and tracking of the optical marker. Preferably, the optical sensor device is a (calibrated) 3D system, e.g., a stereo camera system or a stereo laser scanner system, which can determine the three-dimensional position of the applicator unit by viewing it from different perspectives.

[0024] Furthermore, it is proposed that the tracking system includes, or is designed as, at least one camera, which is intended to determine the instantaneous 3D position data of the applicator unit, at least partially, based on image processing. This advantageously enables particularly simple and continuous position tracking of the applicator unit, which in particular allows for a very compact and lightweight design of the applicator unit. The camera can form part of the optical sensor device, especially the stereo camera system. The image processing can be provided for marker detection and / or tracking. Alternatively, the image processing can be provided for photometry, which can be used to track the applicator unit. The image processing can be performed by the processing unit or by a separate processing unit, e.g., a dedicated computer.a dedicated processing unit of the camera.

[0025] Furthermore, it is proposed that the tracking system include one or more of the following sensors: accelerometer, gyroscope, magnetometer, and gravity sensor. This would advantageously enable the safe and / or reliable acquisition of 3D position data and, if applicable, other data from the applicator unit.

[0026] If the tracking system is designed to determine the instantaneous 3D position data of the applicator unit, at least partially, based on a sensor combination, in particular sensor fusion, of at least two of the aforementioned sensors (electromagnetic tracking device, angle encoder, camera, accelerometer, angular acceleration sensor, geomagnetic field sensor, gravity sensor), a particularly high precision in determining the 3D position data can be advantageously achieved. Redundancy can be advantageously created. Particularly high reliability of the determined 3D position data can be advantageously achieved.

[0027] Furthermore, it is proposed that the tracking system be designed to determine the current 3D position data of the applicator unit, at least partially, based on a combination of data from marker tracking performed by the optical sensor device and data from at least one of the aforementioned sensors (accelerometer, angular accelerometer, geomagnetic field sensor, gravity sensor). This advantageously allows for particularly high precision in determining the 3D position data. It also advantageously creates redundancy, for example, to compensate for any malfunctions of individual sensors. Finally, it advantageously achieves particularly high reliability of the determined 3D position data.

[0028] Furthermore, it is proposed that the computing unit be designed to calculate the surface approximation in such a way that the 3D output model of the body part, which in particular represents a parameterized 3D output surface model, is adapted, at least in the planar body area, so that the received 3D position data lie with a minimal error on a surface of the surface approximation, which in particular represents a parameterized 3D approximation surface model formed by a modification of the 3D output surface model, preferably of parameters of the parameterized 3D output surface model, wherein preferably the strength of a change of at least one local geometric surface property, for example a surface shape or a surface twist / surface torsion of the 3D output surface model, is limited by software.This advantageously ensures that the surface approximation reliably and accurately depicts the respective flat body area, especially if the flat body area is slightly shifted during treatment.

[0029] Advantageously, a particularly precise surface approximation, tailored to the specific organism being treated, can be obtained. A parameterized 3D source surface model is, in particular, a mathematical or computer-aided description of a three-dimensional surface defined by parameters. These parameters preferably allow the shape, structure, or properties of the three-dimensional surface to be controlled and modified through simple adjustments. The computing unit specifically includes the software constraint. This constraint stipulates that the local geometric surface property, such as the surface shape, may only change within limits such that the corresponding body part remains clearly recognizable from the shape. The software constraint can include maximum ranges for changes to certain surface properties relative to the 3D source surface model.

[0030] Additionally, it is proposed that the processing unit be designed to identify wound areas on the flat body surface to be treated, based on camera images from either an external or internal camera to the therapy system. This can advantageously improve the treatment, its evaluation, and / or its visualization on the treatment map. Specifically, wound area detection is performed using an image recognition algorithm that scans the camera images. The camera used for wound area detection can be the camera of the tracking system or the optical sensor device. However, the camera for wound area detection can also be a different camera or a separate camera specifically designed for this purpose.

[0031] In particular, the detected wound area can be saved in the storage unit. Specifically, the detected wound area can be overlaid with the 3D position data of the individual treatment steps and / or with the surface approximation. Specifically, the detected wound area can be visualized together with the 3D position data, e.g., on a display unit of the therapy system. Specifically, the processing unit is designed to assign the surface points of the surface approximation to the detected wound areas. The treatment can then be specifically targeted directly within the wound area, specifically within the indirect wound area (wound area edge), and / or specifically outside the wound area.

[0032] Furthermore, it is proposed that the processing unit be designed to define 3D reference position data points in the vicinity of the wound area or at the edges of a wound forming the wound area, based on the detected wound areas. This data would then preferably be used during therapeutic treatment to allow treatment to be applied only to the direct or indirect wound area. This would advantageously eliminate the need for manual marking of wound areas. User comfort could also be improved, for example, by ensuring that therapeutic waves are applied only to the direct wound area and / or the indirect wound area, i.e., within a defined vicinity of the wound area, and / or outside the wound area. The 3D reference position data points could also advantageously facilitate the re-establishment of relative positions even if the flat body area shifts slightly.

[0033] Furthermore, it is proposed that the processing unit be designed to use a modified 3D source model for calculating the surface approximation. This modified model is adapted from the 3D source model retrieved by the storage unit by 3D reference position data points, initially defined or determined before / at the start of treatment, particularly automatically using a camera or similar device and / or manually using the applicator unit. This advantageously simplifies and / or accelerates the generation of the surface approximation. A high degree of robustness against displacements of the planar body area can also be achieved. The 3D reference position data points form so-called landmarks, which can mark prominent points / locations of the planar body area. The modified 3D source model differs from the 3D source model / standard model of the body part.The adapted 3D source model includes, in particular, an initial modification of the 3D source model / the standard model of the body part that is individual for each living being. This initial modification is preferably achieved through presets of 3D reference position data points or through initial pattern recognition (e.g.,

[0034] Wound edge detection) is generated.

[0035] Furthermore, it is proposed that the computing unit be designed to start with a modified 3D source model of a wounded side of a body part when calculating the surface approximation. This source model is generated by transferring and / or mirroring a previously generated surface approximation or a modified 3D source model of an unwounded side of the same body part (e.g., right abdomen / left abdomen) or of another body part similar to this one (e.g., right knee / left knee). This allows for the advantageous optimization, acceleration, and / or elimination of the surface approximation of the wounded side. It also advantageously ensures that the surface approximation of the wounded side begins with a relatively well-fitted 3D source model.This can advantageously prevent unforeseen and / or unexpected wound shapes from generating artifacts or errors that could lead to faulty surface approximations. The wounded side of the body part and the unwounded side of the body part can both belong to the same (treatable) flat body area. The wounded side of the body part exhibits a wound / injury. The unwounded side of the body part is free of significant wounds / injuries. A wound is, in particular, a disruption or damage to the tissue integrity of the body part.

[0036] Furthermore, it is proposed that the computing unit be designed to generate a point cloud from the received 3D position data and to calculate the surface approximation based on this point cloud using a suitable algorithm either programmed into the computing unit or retrievable from the memory unit. This advantageously allows for a precise and efficient surface approximation.

[0037] If the algorithm is a Hoppes algorithm, a power crust algorithm, a Gaussian splatting algorithm, an alpha shapes algorithm, a Delaunay triangulation algorithm, a ball pivoting algorithm, a Poisson surface reconstruction algorithm, a marching cubes algorithm, an advancing front algorithm, a radial basis function algorithm, a moving least squares algorithm, or a scale-space algorithm, advantageous properties regarding the generation or accuracy of the surface approximation can be achieved. Advantageously, when using the Hoppes algorithm, a precise definition of the surface, supporting both its geometry and orientation, can be achieved. The Hoppes algorithm is particularly advantageous the denser the point cloud. Advantageously, when using the power crust algorithm, a robust reconstruction of the surface, especially for thin and hollow structures, can be achieved.The Gaussian splatting algorithm is particularly well-suited for noisy point clouds. It effectively smooths the surface by superimposing Gaussian functions without completely losing detail. The Alpha Shapes algorithm offers particularly flexible control over the level of detail in the surface approximation. It is especially advantageous for surfaces with both convex and concave features. The Delaunay triangulation algorithm provides excellent numerical stability, particularly for subsequent calculations. Finally, the Ball pivoting algorithm achieves exceptionally high efficiency for point clouds containing well-distributed, dense points.Advantageously, the Poisson Surface Reconstruction algorithm achieves high robustness against noisy and incomplete point clouds. Advantageously, the Marching Cubes algorithm yields a polygonal surface capable of handling complex topologies. Advantageously, the Advancing Front algorithm generates surfaces with smooth edges. It also offers controlled mesh generation that can fill gaps and continuously extend surfaces. Advantageously, the Radial Basis Function algorithm generates particularly good surfaces, even with irregularly distributed points. Advantageously, the Moving Least Squares algorithm achieves high efficiency with noisy data.The use of the scale-space algorithm offers the advantage of identifying surface structures at multiple levels of detail, allowing for particularly good differentiation between coarse and fine surface features. Specifically, the processing unit is designed to select one of several available algorithms for generating the surface approximation, depending on the available data, especially 3D positional data. For example, if a particularly dense point cloud is present, the processing unit could select the Hoppes algorithm or the ball pivoting algorithm. If, for example, a thin or hollow body part is to be processed, the processing unit could select the power crust algorithm.For example, if a particularly noisy point cloud is present, the processing unit might select the Gaussian splatting algorithm, the Poisson surface reconstruction algorithm, or the moving least squares algorithm. If, for example, a level of detail adjustment is desired, or a body part with multiple concave and convex areas is to be processed, the processing unit might select the alpha shapes algorithm. If, for example, post-processing is required, the processing unit might select the Delaunay triangulation algorithm. If, for example, smooth edges are desired, the processing unit might select the advancing front algorithm. If, for example, a body part has a complex topology, the processing unit might select the marching cubes algorithm or the scale space algorithm.For example, if there is an irregular distribution of points in a point cloud, the processing unit could select the radial basis function algorithm. Specifically, programs with several of the aforementioned algorithms are stored on the memory unit for this purpose.

[0038] Furthermore, it is proposed that the therapy system includes an initial model creation device comprising at least one camera for capturing at least one image, in particular a still image, a moving image, or a stereoscopic still or moving image, of the body part of the living being or of another living being of the same species, or an interface for receiving at least one image of the body part of the living being or of another living being of the same species, and comprising at least one computing unit, in particular the computing unit, which includes at least one evaluation module trained using real body data and configured to create the 3D initial model based on at least one image. This advantageously allows for a particularly efficient, effective, and / or reliable surface approximation, especially by enabling initial adjustments before the start of treatment.The camera can be one of the aforementioned cameras or a separate camera different from those mentioned above. For example, the camera could also be a camera on a portable electronic device such as a mobile phone, smartphone, or tablet. In this case, the processing unit receives the image from the portable electronic device via the interface.

[0039] If the creation of the 3D model from at least one image by the evaluation module involves a photometric method, significant cost efficiency can be achieved. Furthermore, a high degree of flexibility in data acquisition can be advantageously achieved. Additionally, a quick and simple initial adjustment of the 3D model at the start of treatment can be advantageously achieved.

[0040] Additionally, it is proposed that the evaluation module include a machine learning algorithm designed to receive at least one image as input and trained to output a parameterized 3D output model of the body part depicted in the image, adapted to the image content. This advantageously optimizes and / or accelerates the initial adaptation of the 3D output model. It also advantageously enables an evaluation specifically optimized for the body parts intended for treatment. Furthermore, it advantageously improves accuracy and reduces the error rate. The machine learning algorithm is preferably a deep learning algorithm.The machine learning algorithm is specifically an algorithm capable of learning and reconstructing geometries, textures, and / or other features of a body part from image data. For example, the machine learning algorithm could be a convolutional neural network (CNN) algorithm with an encoder-decoder architecture, such as...

[0041] Pixel2Mesh or ShapeNet. Alternatively, the machine learning algorithm could be a Generative Adversarial Network (GAN) algorithm (e.g., Pix2Vox or 3D-GAN), a Neural Radiance Field (NRF) algorithm (e.g., NeRF), or a Rapid Convolutional Network (e.g., MeshCNN). Other machine learning algorithms or hybrid approaches that combine deep learning and established classical methods are also conceivable. All of these machine learning algorithms offer particular advantages, including the ability to reconstruct precise 3D surface models from image data, fill in incomplete information, and / or generate realistic, parameterized models.

[0042] Furthermore, it is proposed that the therapy system includes a camera that is integrated into the applicator unit, mounted on the applicator unit, or designed separately from the applicator unit and positioned remotely. The camera is intended to capture at least one image, preferably a video or video stream, of the treated area of ​​the body during at least one treatment phase, preferably during the entire treatment. This advantageously allows for treatment optimization. It also advantageously enables visualization of the treatment progress. Advantageously, a real image can be superimposed on the treatment map. Advantageously, it facilitates the treatment of large areas of the body that are covered, for example, by films or the like, or contaminated, for example, by blood emerging from wounds to be treated.The camera is preferably designed differently and separately from the aforementioned cameras. A line of sight of the camera, in particular of the camera integrated into the applicator unit, is preferably arranged approximately parallel to the 3D orientation of the applicator unit.

[0043] In this context, it is proposed that the camera, which is separate from and remotely positioned from the applicator unit, be part of a mobile device, such as a smartphone or tablet, or the like. This device does not constitute a fixed component of the therapy system but can transmit image data, including at least the image itself, to the therapy system, particularly the processing unit, via an interface. This allows for a simple and flexible design. Advantageously, an existing camera from a mobile device can be used, thus reducing the number of components in the therapy system. Furthermore, it is conceivable that a patient and / or a therapist could directly monitor the treatment via the mobile device, particularly by displaying the image captured by the camera alongside the current, and potentially different, information.The therapy map, which displays the 3D positional data of treatment sections, is superimposed on the camera. Alternatively, however, it is also conceivable that the camera, which is separate from and positioned remotely from the applicator unit, is a fixed component of the therapy system. A viewing axis of the camera of the mobile device or the therapy system should preferably be aligned or adjustable approximately parallel to the 3D orientation of the applicator unit or approximately perpendicular to the flat area of ​​the body being treated.If the processing unit is designed to determine, based on at least the captured image, the position and extent of the planar body region and / or at least one characteristic body feature within the planar body region, treatment tracking can be advantageously optimized, particularly through the superimposed display of a real image and the treatment map on the mobile device or another display unit. In particular, the assignment of 3D position data to image areas can be simplified.In particular, based on the determined location or extent of the planar body area or based on the determined and / or recognized characteristic body feature, 3D reference position data points can be defined on the body part, which can then preferably be used for an initial adjustment of the 3D source model / the standard model of the body part on which the surface approximation is based.

[0044] Furthermore, the 3D reference position data points can be tracked, for example, using a camera, so that slight displacements or shifts of the body part can be detected and compensated for. The characteristic body feature can be, among other things, a wound, a wound edge, a fold, a wrinkle pattern, pigmentation, a mole, a bone relief, a muscle relief, a tendon relief, a vascular relief, a cartilage relief, a scar, a vein course, or an acrum.

[0045] Alternatively or additionally to the aforementioned use of a camera, it is proposed that the applicator unit have at least one integrated or mounted ultrasound sensor designed to capture at least part of the surface of the flat body area during at least one treatment phase. The processing unit is designed to use the ultrasound sensor data to determine the location, extent, and / or at least one of the characteristic body features within the flat body area. This advantageously allows for further optimization of treatment tracking, particularly through the superimposition of an ultrasound signal and the real-world image and / or the treatment map on the mobile device or other display unit.Advantageously, information about visually obscured parts of the body can be displayed during treatment. For example, a covering such as a film or bandage, a topical medication, a gel, or bodily fluid like blood may obscure the direct view of the area being treated. The ultrasound signal from the ultrasound sensor can still be used to obtain and display information about the area of ​​the body lying beneath the covering, tonic, gel, or bodily fluid.

[0046] Furthermore, it is proposed that the ultrasound sensor, or another ultrasound sensor, of the applicator unit be designed to detect at least a portion of the bony structure of the body part being treated, located beneath the surface of the flat body area, during at least one treatment phase. This would allow for advantageous optimization of the treatment. Advantageously, more targeted treatment of regions lying beneath the surface of the flat body area could be achieved. Advantageously, visualization of the bones lying beneath the surface of the flat body area could be enabled during treatment.

[0047] If the processing unit is designed to determine the body part to which the currently treated area belongs, based on the ultrasound sensor data, particularly the bone shapes and / or positions determined from the ultrasound sensor data, a high degree of treatment safety can be advantageously achieved. This could also advantageously enable the automatic selection of a suitable 3D source model / standard model for the planned treatment. It is also conceivable that an initial pre-adjustment of the 3D source model / standard model could be performed based on the recognized dimensions of the bony structure. Advantageously, the position and / or size of the body part to be treated could be identified.

[0048] Additionally, it is proposed that the processing unit be designed to create a visualization of the bones beneath the treated area of ​​the body based on the ultrasound sensor data and preferably to display this visualization on a display unit, for example, superimposed on the therapy map and / or on the actual image of the treated area of ​​the body captured by the camera. This allows for advantageous treatment optimization. Furthermore, the user can advantageously position the therapeutically effective physical waves, particularly shock waves, more precisely. Shock waves, in particular, penetrate body tissue and can thereby also reach bony structures or areas between bony structures (e.g., for the treatment of calcific tendinitis of the shoulder).Visualization offers the advantage of allowing more precise targeting of treatment sites located below the flat body area, or treatment sites that are on or in a bone structure or at a distance from a bone structure.

[0049] Alternatively or additionally, it is proposed that the processing unit be designed to calculate a visualization of bones lying beneath the flat body surface, based on the 3D position data of the applicator unit, acquired particularly during the treatment phases, and / or based on the surface approximation. This allows for the advantageous optimization of treatment. It also allows the user to position the therapeutically effective physical waves, especially shock waves, more precisely. Furthermore, it enables bone visualization even without the use of ultrasound sensors or similar devices. Finally, it allows for the optimization of bone visualizations generated using ultrasound sensors, making them faster and / or more accurate.

[0050] In particular, the processing unit includes a machine learning algorithm specifically trained for bone visualization. This algorithm receives the 3D position data of the applicator unit and / or the current surface approximation as input and outputs a bone dataset that can be superimposed with the camera image data, the therapy map, or the parameterized approximated 3D surface data. The aforementioned types of machine learning algorithms can also be used for this task.

[0051] In this context, it is proposed that the applicator unit include a compliance sensor, particularly an integrated or mounted one, specifically a skin and / or tissue compliance sensor, which is designed to measure the compliance of tissue in contact with the therapy head within the flat body area. The processing unit is designed to adjust at least the depth of a layer of bones below the flat body area when calculating the visualization of the bones below the flat body area, based on measurement data from the compliance sensor. This advantageously optimizes the accuracy, particularly the positional accuracy, of the bone visualization.Advantageously, precise output of bone positions can be enabled for individuals of the same species with varying body mass, physique, build, and / or body fat percentage. Reliable visualization can also be advantageously achieved for obese patients. The compliance sensor can be a force sensor or a pressure sensor. Alternatively, the compliance sensor could also be an ultrasound sensor, in particular an ultrasonic sensor. Preferably, a sensor surface of the compliance sensor is arranged on the treatment head.

[0052] Furthermore, it is proposed that the computing unit have a user interface designed to receive input from the user indicating which body part(s) are to be treated. Based on this input, the computing unit is then designed to select the appropriate 3D source models for creating the surface approximation for the subsequent treatment phases. This allows for advantageous optimization of the treatment.

[0053] It is advantageous to ensure that the appropriate 3D source model is always used as the basis for the surface approximation. The user interface can include a tactile input unit such as one or more buttons or be operated via voice control. Other user interfaces familiar to experts are also conceivable. The user interface can also simply be a data reception interface for the processing unit, through which the processing unit receives inputs made on external input devices, e.g., a tablet or a smartphone, etc.

[0054] Furthermore, it is proposed that the therapy system include a display unit or a visualization output interface for an external display unit, the display unit being designed to visually output at least the determined bone structure, preferably as an augmented reality display. This can advantageously optimize treatment and / or improve user comfort. The display unit can be, for example, an augmented reality headset or a virtual reality headset. Alternatively, the display unit can also be a tablet, a smartphone, a computer screen, or another electronic device with a sufficiently high-resolution display. In particular, for the augmented reality display, the image from a camera, e.g., of the aforementioned mobile device, can be augmented using the visualizations calculated / created by the processing unit.The display unit could also be a transparent screen, positioned within the user's field of vision and in front of the area of ​​the body to be treated. The calculated / created visualizations (perspectively aligned with the user's viewing direction) can be projected onto this screen. This allows the user to advantageously see both the area of ​​the body to be treated and the visualizations on the screen, which simplify and guide the treatment. The visualization output interface is specifically designed to output the visualizations calculated / created by the processing unit to an external display unit. This external display unit could be, among other things, a smartphone, a tablet, or another electronic device with a sufficiently high-resolution display.The visualization of the bone structure can be achieved in particular by a corresponding (parameterized) 3D dataset.

[0055] Furthermore, it is proposed that the processing unit be configured to enable or disable the application of the propagating, therapeutically effective physical waves depending on the therapy system's detection of the specific body area, particularly the body part, to which the applicator unit is currently attached, and / or depending on the position of the applicator unit's therapy head relative to a wound area on the body area to be treated, and / or depending on the orientation of the therapy head relative to the body area to be treated. This advantageously achieves a high level of treatment safety. It also helps to avoid incorrect treatments or even damage to healthy body areas caused by the therapeutically effective physical waves.

[0056] For example, it can be advantageously prevented that shock waves can affect the lungs of a living being or an embryo located in the womb of a living being. In particular, the processing unit is designed to recognize the body part to which the applicator unit is currently attached and to check whether it matches a treatment plan. If there is no match, at least one wave generation function for generating the physically therapeutic waves of the applicator unit is deactivated. If there is a match, at least the wave generation function of the applicator unit is activated. Specifically, the processing unit is designed to check whether the therapy head is in contact with the flat body area inside or outside the wound area.If the therapy head is positioned outside the wound area, resting against a flat area of ​​the body, at least the wave generation function of the applicator unit is deactivated. If the therapy head is positioned within the wound area, resting against a flat area of ​​the body, at least the wave generation function of the applicator unit is activated. Alternatively, instead of activation and deactivation, a display and / or warning message could be issued, indicating that the wound area has been left or that a different body part is being treated than intended.

[0057] Furthermore, it is proposed that the processing unit be configured to suggest, automatically set, and / or automatically adjust standardized and / or optimized treatment parameters for the application of the propagating, therapeutically effective physical waves, depending on the detection by the therapy system of the area of ​​the body, particularly the body part, to which the applicator unit is currently applied. This can advantageously optimize treatment and / or improve user comfort.

[0058] Treatment parameters can include, for example, the aforementioned parameters of the physically therapeutically effective waves.

[0059] Furthermore, it is proposed that the processing unit be configured to store at least the 3D position data of the individual treatment sections, assigned to the surface points of the surface approximation, and a 3D parameter surface representing the surface approximation, on the storage unit or on another storage unit, preferably patient-specific / treatment-specific. This advantageously ensures comparability later on. Moreover, the most recent surface approximation can advantageously be used as the 3D starting model for a subsequent treatment, thus accelerating the subsequent treatment, particularly since 3D reference position data points and / or approximate dimensions, etc., are already known and taken into account.

[0060] Additionally, it is proposed that the processing unit be configured to store determined 3D orientations and / or set treatment parameters for each surface point of the surface approximation, to which 3D position data from one of the individual treatment sections are assigned, on the storage unit or on another storage unit, preferably patient-specific. This advantageously allows for the optimization of a treatment sequence with multiple individual treatments, in particular by achieving improved coordination, improved comparability, and / or faster treatments.

[0061] Furthermore, it is proposed that the computing unit be configured, in particular to perform and / or enable a comparison of two or more than two treatments of the same area of ​​the same organism or of two different organisms of the same species, and to align the SD parameter surfaces of surface approximations of the two or more than two different treatments of the same area of ​​the same organism or of two different organisms of the same species. This advantageously allows for comparison. Advantageously, treatment progress can be visualized. Advantageously, treatment differences, e.g., between different organisms of the same species with the same symptoms, can be visualized. This can enable further research and development of treatment methods.

[0062] Furthermore, it is proposed that the computing unit be configured to detect swelling and / or reduction of swelling, at least in parts of the same body region, by comparing the 3D parameter surfaces of surface approximations of two or more different treatments of the same body region of the same organism. This would advantageously make treatment progress visible. It would be beneficial to easily identify which parts of the body region are already showing progress and which are not. Subsequent treatment plans could then be adjusted accordingly. This would advantageously optimize a treatment sequence involving multiple treatments.

[0063] If the processing unit is configured to graphically display at least the 3D position data of the individual treatment sections assigned to the surface points of the surface approximation, and a 3D parameter surface representing the surface approximation, via the display unit of the therapy system or via an external display unit, a precise visualization of the physical effect in the area of ​​the body at the application sites can be advantageously achieved. This also advantageously prevents individual application sites from experiencing excessively strong effects and ensures that the application sites are optimally distributed across the area of ​​the body.Furthermore, it is conceivable that 3D position data of the individual treatment sections of a previous treatment of the same flat body area of ​​the same living being can be displayed, so that - depending on the requirements / treatment - exactly the same application sites can be treated again or other application sites can be treated in a targeted manner.

[0064] Furthermore, a method for operating the therapy system is proposed, which is intended for the non-invasive, non-surgical treatment of at least the flat body area of ​​the living being, by means of the applicator unit, preferably manually and / or robotically guided,

[0065] wherein propagating physical therapeutic waves, in particular pressure waves, preferably shock waves, are applied to the flat body area by means of the therapy head of the applicator unit, wherein instantaneous 3D position data of the applicator unit, in particular of the therapy head of the applicator unit, are determined by means of the tracking system of the applicator unit during several treatment phases of the treatment of the flat body area, and wherein the 3D output model of the body part of the living being, in particular of at least the same species as the being to be treated, is retrieved from the storage unit, and based on the 3D position data acquired by means of the tracking system, the surface approximation of the body part with the flat body area undergoing treatment, which is derived from the 3D output model and in particular differs at least locally from the 3D output model, is calculated.and the 3D position data associated with individual treatment phases are assigned to surface points of the surface approximation. This advantageously enables a particularly precise, especially millimeter-accurate, and at the same time efficient determination and recording of treatment positions on the actual treated area of ​​the organism's body, which is achieved without prior, complex, precise body measurements such as CT scans or similar procedures. This allows for a significant reduction in treatment costs and treatment times.

[0066] Furthermore, it is proposed that during treatment, particularly at the beginning, at least one 3D reference position data point on the organism, especially within the flat body area, be determined and / or automatically detected by the applicator unit. This advantageously enables rapid orientation. If the applicator unit determines the position, no additional equipment is required to establish the 3D reference position data point. If automatic detection is used, it is advantageous that no contact with the flat body area, which may be injured and therefore painful, is necessary.

[0067] Furthermore, it is proposed that during treatment, particularly at the beginning of the treatment, at least two, preferably at least three, 3D reference position data points be determined and / or automatically detected by the applicator unit, and that a 3D parameter surface forming a customized 3D output model be calculated based on the determined and / or detected 3D reference position data points. This advantageously optimizes the surface approximation, especially since a customized 3D output model that is closer to the real situation can be used instead of the standard organism model. In particular, 3D orientations determined and / or detected in parallel with each 3D reference position data point can also be taken into account when creating the SD parameter surface forming the customized 3D output model.

[0068] If the area of ​​the body to be treated and / or the specific body part to be treated is automatically identified based on the determined and / or recognized 3D reference position data points, a high degree of treatment safety can be advantageously achieved. It is also advantageous to be able to verify that the correct body part is indeed being treated. Furthermore, a suitable 3D source model for surface approximation can be automatically selected to match the body part to be treated.

[0069] Furthermore, if the 3D output model of the area of ​​the body to be treated and / or the body part to be treated is automatically digitally (three-dimensionally) aligned and / or parameterized based on the determined and / or recognized 3D reference position data points, a particularly efficient treatment can be advantageously enabled.

[0070] Advantageously, this allows for particularly efficient surface approximation. A starting point for the surface approximation can be defined. In particular, the 3D source model is aligned so that its position in space matches the position of the corresponding body part in space.

[0071] It is also conceivable that the therapy system, particularly the application unit, has one or more additional sensors specifically designed to monitor the organism's bodily functions. These monitored bodily functions could, for example, detect sensations such as pain, nervousness, stress, etc., allowing the treatment, such as the intensity or frequency of the delivered therapeutic waves, to be adjusted accordingly. The monitored bodily functions could also be used to identify and localize areas of inflammation, enabling more targeted treatment. The sensory-monitored bodily functions could, among other things,This could include a respiratory rate, CC concentration in exhaled air, heart rate, body temperature, blood pressure, blood oxygen saturation, blood sugar level, sweat analysis, muscle activity, brain activity, skin moisture, or skin resistance.

[0072] The therapy system and method according to the invention are not limited to the application and embodiment described above. In particular, the therapy system and method according to the invention may, to achieve a functionality described herein, comprise a different number of individual elements, components, process steps, and units than the number specified herein.

[0073] Drawings

[0074] Further advantages will become apparent from the following description of the drawings. The drawings illustrate an embodiment of the invention. The drawings, the description, and the claims contain numerous features in combination. A person skilled in the art will expediently consider the features individually and combine them into meaningful further combinations.

[0075] They show:

[0076] Fig. 1 shows a living being treatable by means of the therapy system, Fig. 2 shows a schematic representation of the therapy system and a body part of the living being treated by means of the therapy system.

[0077] Fig. 3 shows a schematic representation of an applicator unit of the therapy system, which is held by a robot arm; Fig. 4 shows a schematic representation of a 3D initial model underlying the treatment using the therapy system and a surface approximation created on the basis of this 3D initial model using 3D position data from a tracking system of the applicator unit.

[0078] Fig. 5 shows a schematic flowchart of a procedure using the therapy system,

[0079] Fig. 6 shows a schematic representation of a surface approximation process, in which the 3D initial model is modified by measured 3D position data.

[0080] Fig. 7 is an exemplary visualization of the surface approximation with surface points of treatment sections and Fig. 8 is an exemplary visualization of a comparison of treatment sections of two treatments carried out according to the method.

[0081] Description of the exemplary embodiment

[0082] Figure 1 schematically shows a living being treatable by means of a therapy system 58 described and illustrated in this document. The living being is, for example, a human being. Alternatively, however, animals of various species can also be treated by means of the therapy system 58. The living being comprises body parts 28. The body parts 28 comprise planar body areas 10. In Figure 1, several planar body areas 10 that are suitable for treatment by means of the therapy system 58 are indicated by dashed circles. A treatment by means of the therapy system 58 comprises many treatment sections 18, 20. In each of the treatment sections 18, 20, a physically therapeutically effective wave or a physically therapeutically effective wave train is applied / exerted at least once to the planar body area 10. In the Fig.1 are exemplary positions of the treatment sections 18, 20 of the depicted flat body areas 10 indicated as small continuous circles.

[0083] Figure 2 shows a schematic representation of the therapy system 58 and a body part 28 (knee) of the organism treated by means of the therapy system 58. The therapy system 58 is intended for non-surgical treatment of the flat body area 10 of the organism. The therapy system 58 is intended for non-invasive treatment of the flat body area 10 of the organism. The therapy system 58 comprises an applicator unit 12. The applicator unit 12 of Figure 2 is manually operated. Figure 3 shows an applicator unit 12 attached to a robot arm 46. This applicator unit 12 attached to the robot arm 46 is robotically operated.

[0084] The applicator unit 12 includes a wave generation unit 92. The wave generation unit 92 is designed to generate the therapeutically effective physical waves. These therapeutically effective physical waves can be pressure waves. In the embodiment described in connection with the figures, the therapeutically effective physical waves are shock waves. The applicator unit 12 includes a therapy head 14. The therapy head 14 is designed to output the shock waves generated by the wave generation unit 92. The therapy head 14 is designed to apply the shock waves to the flat area of ​​the body 10.

[0085] For this purpose, the therapy head 14 is brought into contact with the flat body area 10 and one or more shock waves are triggered. The shock waves propagate into the tissue of the body part 28 with the flat body area 10 and act on the tissue or on cells / foreign bodies / disease products contained in the tissue. This (physical) action generates therapeutically effective reactions at the cellular and tissue level or destroys foreign bodies or disease products. The applicator unit 12 has a tracking system 16. The tracking system 16 is designed to determine instantaneous 3D position data 30, 32 of the applicator unit 12, in particular the therapy head 14, during treatment phases 18, 20 of the treatment of the flat body area 10. The tracking system 16 is designed to determine the 3D position data 30, 32 relative to a reference point 40. The reference point 40 is fixed in place.Reference point 40 is not in a fixed relative relationship to the organism being treated. Reference point 40 is positioned separately from the organism. Instead of a passive reference position, reference point 40 could also be an active reference position indicator.

[0086] The tracking system 16 comprises at least one tracking element 42. Alternatively, the tracking element 42 could constitute the entire tracking system 16. In the illustrated case, the tracking element 42 is integrated into the applicator unit 12. Alternatively, the tracking element 42 could also be attached externally to the applicator unit 12. Furthermore, as shown by way of example in Fig. 2, the tracking system 16 can have a further or alternative tracking element 94, which is arranged separately from the applicator unit 12. The further tracking element 94 can interact with the tracking element 42 or with one of the multiple tracking elements 42, 94 of the applicator unit 12 to determine the 3D position data 30, 32 of the applicator unit 12 (e.g., if the tracking system 16 includes an electromagnetic tracking device 44).Alternatively, the additional tracking element 94 could also determine the 3D position data 30, 32 of the applicator unit 12 independently of the tracking element 42 (e.g., if the additional tracking element 94 is a camera 54). Several tracking elements 42, 94 of different tracking methods can jointly form the tracking system 16, or only a single tracking element 42 and a single tracking method can be used to determine the 3D position data 30, 32 of the applicator unit 12.

[0087] The embodiment shown in the figures represents an exemplary tracking system 16, which, for illustrative purposes, comprises a variety of tracking methods. The tracking system 16 includes an electromagnetic tracking device 44. The tracking element 42 forms part of the electromagnetic tracking device 44. The tracking element 42 forms a magnetic field receiver of the electromagnetic tracking device 44. The further tracking element 94 forms another part of the electromagnetic tracking device 44. The further tracking element 94 forms a field generator of the electromagnetic tracking device 44, which is designed to generate an electromagnetic field that can be received by the magnetic field receiver of the tracking element 42 and evaluated for 3D position determination.When using electromagnetic sensors (EM sensors), it is essential to ensure that an electromagnetic pulse (EMP) occurring during an electrohydraulic spark discharge of an electrohydraulic shock wave device does not impair its position determination. Some specific examples of how to implement such EMP protection are listed below. For instance, the EM sensor could operate discontinuously, taking measurements between, for example, two consecutive EMPs. Alternatively, the EM sensor could be switched off during the EMP. A reset could also be performed on the EM sensor after a spark discharge and before a measurement. Position data from previous time intervals could also be used to compensate for any interference with the EM sensor's position detection caused by an EMP.At least two EM sensors could be used, so that a malfunction of one EM sensor caused by an EMP can be compensated for by another. An EM sensor could also be protected from an EMP by a Faraday cage, for example, made of copper or aluminum. Furthermore, special EMP filters, surge protection, EMP-resistant antennas, or EMP-resistant radio modules can be used. Frequency ranges that are little or not at all affected by the EMP can also be used for EM tracking. The EM sensor, which normally determines positions at high frequencies, could also be operated at a very low frequency in the range of 1-20 Hz, as this may be sufficient for tracking. The measures mentioned above may also be necessary and implemented for electromagnetic or piezoelectric shock wave devices, which are also operated with high voltage.The therapy system 58 includes an EMP protection device 99 designed to implement one or more of these examples. The EMP protection device 99 is designed to protect at least one electromagnetic sensor of the electromagnetic tracking device 44, e.g., the tracking element 42 or the further tracking element 94 of the electromagnetic tracking device 44, from the effects of electromagnetic pulses (EMP), which can occur particularly during the generation of the physical therapeutically effective waves. The tracking system 16 also includes a marker 50. The marker 50 also forms a tracking element 42 of the tracking system 16 connected to the applicator unit 12. The marker 50 is applied to an outer surface of the applicator unit 12. The therapy system 58, in particular the tracking system 16, also includes an optical sensor device 52.The optical sensor device 52 also forms a further tracking element 94' arranged separately from the applicator unit 12. The optical sensor device 52 is designed as a camera system with a camera 54. The optical sensor device 52 serves to detect and track the marker 50. The camera 54 is intended to determine the instantaneous 3D position data 30, 32 of the applicator unit 12 based on image processing. The image processing can identify the marker 50 and determine its position in space. Alternatively, the image processing can also detect the applicator unit 12 itself and determine its position in space independently of markers 50. The tracking system 16 also includes one or more further tracking sensors 56.The additional tracking sensor(s) 56 can be: accelerometers, angular accelerometers, geomagnetic field sensors, or gravitational sensors. The additional tracking sensor(s) 56 are integrated into the applicator unit 12. Each additional tracking sensor 56 forms a tracking element 42". The tracking system 16 is designed to determine the instantaneous 3D position data 30, 32 of the applicator unit 12, at least partially, based on a sensor combination of at least two of the aforementioned tracking elements 42, 42', 42", 94, 94'. The tracking system 16 is designed to determine the instantaneous 3D position data 30, 32 of the applicator unit 12, at least partially, based on a combination of data from the marker tracking performed by the optical sensor device 52 and data from at least one of the aforementioned additional tracking sensor(s) 56.

[0088] In the arrangement example for the applicator unit 12 shown in Figure 3, which includes the robot arm 46, the tracking system 16 has an angle encoder 48 integrated into the multi-axis robot arm 46. Depending on whether the robot arm 46 is assigned to the applicator unit 12 or not, the angle encoder 48 forms a tracking element 42'” or another tracking element 94”. In addition to determining the 3D position data 30, 32, the tracking system 16 is also designed to determine 3D orientations 88 of the applicator unit 12, in particular of the therapy head 14, during the several treatment phases 18, 20 of the treatment of the flat body area 10. The tracking system 16 has an inertial sensor 96 for detecting the 3D orientations 88.

[0089] The therapy system 58 has a processing unit 22. The processing unit 22 has access to a storage unit 24. In the illustrated case, the processing unit 22 comprises the storage unit 24. A 3D initial model 26 of the body part 28 is stored in the processing unit 22. The 3D initial model 26 is a standard model of an organism of the same species as the organism being treated. Furthermore, adapted 3D initial models 62 can be stored in the storage unit 24. The adapted 3D initial models 62 can be created by means of preliminary analyses, e.g., by an initial model creation device 68, or based on previous treatments.The adapted 3D source model 62 can be modified in the preliminary analysis by altering the 3D source model 26 depending on 3D reference position data points 64, 90, which were automatically recorded and initially defined using the camera 54 or manually using the applicator unit 12 before / at the beginning of the treatment. The processing unit 22 is designed to receive the 3D position data 30, 32 of the applicator unit 12 acquired by the tracking system 16. Based on the received 3D position data 30, 32, the processing unit 22 is designed to calculate a surface approximation 34 (see Fig. 4) of the body part 28 with the treated area 10, based on the 3D source model 26 or the adapted 3D source model 62. The surface approximation 34 deviates at least locally from the 3D source model 26 or the adapted 3D source model 62.

[0090] The processing unit 22 is designed to generate a point cloud 66 from the received 3D position data 30, 32. The processing unit 22 is designed to calculate the surface approximation 34 based on the point cloud 66 using a suitable algorithm programmed into the processing unit 22 or retrievable from the memory unit 24. The algorithm can be a Hoppes algorithm, a power crust algorithm, a Gaussian splatting algorithm, an alpha shapes algorithm, a Delaunay triangulation algorithm, a ball pivoting algorithm, a Poisson surface reconstruction algorithm, a marching cubes algorithm, an advancing front algorithm, a radial basis function algorithm, a moving least squares algorithm, a scale space algorithm, or a combination of two or more of the aforementioned algorithms.The processing unit 22 can be configured to select and apply one or more suitable algorithms, depending on the circumstances and measurement conditions. The processing unit 22 is designed to recognize wound areas 60 on the flat body area 10 to be treated, based on camera images from camera 54. The processing unit 22 includes an image recognition algorithm for this purpose. The image recognition algorithm may or may not be a specially trained machine learning algorithm. The processing unit 22 is designed to define 3D reference position data points 64, 90 in the vicinity of the wound area 60 or at the edges of a wound forming the wound area 60, based on the recognized wound areas 60.

[0091] The therapy system 58 includes an output model creation device 68. In the illustrated case, the output model creation device 68 is formed by the computing unit 22. The output model creation device 68 comprises an interface 98 for receiving images of the body part 28 of the living being captured by the camera 54. The output model creation device 68, in particular the computing unit 22, includes an evaluation module 72. The evaluation module 72 includes a machine learning algorithm. The machine learning algorithm of the evaluation module 72 receives the images as input. The machine learning algorithm is trained using real body data and is configured to output 3D output models 26 based on the images or adapted 3D output models 62.The machine learning algorithm of the evaluation module 72 applies a photometric method to create the 3D output model 26 or the adapted 3D output model 62. Alternatively or additionally to the output model creation device 68, the computing unit 22 has a user interface 84, which is designed to receive input from the user indicating which body part(s) 28 are currently to be treated. The computing unit 22 is designed to automatically, or depending on the user's input, select the 3D output models 26 suitable for the following treatment sections 18, 20 for creating the surface approximation 34 from a plurality of 3D output models 26 available in the storage unit 24.

[0092] The therapy system 58 includes an additional camera 70, which is separate from and located at a distance from the applicator unit 12. Alternatively, the additional camera 70 could also be integrated into or mounted on the applicator unit 12. The additional camera 70 is directed towards the flat area of ​​the body 10. The additional camera 70 is intended to capture images of the treated flat area of ​​the body 10 during treatment phases 18 and 20. The camera 70 is part of a mobile device 74. In the illustrated case, the mobile device 74 is a mobile phone / smartphone. The mobile device 74 is not a fixed component of the therapy system 58. The mobile device 74 can transmit image data to the processing unit 22 via the interface 98.The processing unit 22 is designed to determine, based on at least the captured image, the position of the planar body region 10 in space, the extent of the planar body region 10, and / or a characteristic body feature 76 within the planar body region 10. The characteristic body feature 76 is exemplified as a bone relief of a knee joint / a cartilage relief of a patella of the depicted body part 28, which is designed as a leg. The therapy system 58 has a visualization output interface for outputting calculated visualizations to an external display unit 86. The visualization output interface is formed by the interface 98 of the processing unit 22. Alternatively, the therapy system 58 could also have an internal display unit. The external display unit 86 is formed by the mobile device 74. The external display unit 86 is a screen of the mobile device 74.The display unit 86 is designed to visually output at least the treatment sections 18 and 20, in particular surface points 36 and 38 on the surface approximation 34, where the treatment sections 18 and 20 / shockwave treatments were performed. The processing unit 22 is configured to graphically display at least the 3D position data 30 and 32 of the individual treatment sections 18 and 20, assigned to the surface points 36 and 38 of the surface approximation 34, and a 3D parameter surface representing the surface approximation 34, via the external display unit 86. The display unit 86 is designed to output the treatment sections 18 and 20, or the associated surface points 36 and 38, as an augmented reality display. The computing unit 22 is designed to assign the 3D position data 30, 32 belonging to the individual treatment sections 18, 20 of the treatment to the surface points 36, 38 of the surface approximation 34.

[0093] The applicator unit 12 has an ultrasonic sensor 78. The ultrasonic sensor 78 is integrated into the applicator unit 12, but could also simply be attached to it. The ultrasonic sensor 78 is designed to detect at least part of the surface of the flat body area 10 during at least one treatment phase 18, 20 of the treatment. The processing unit 22 is designed to determine, based on the data from the ultrasonic sensor 78, the position of the flat body area 10 in space, the extent of the flat body area 10, and / or at least the characteristic body feature 76 within the flat body area 10. The processing unit 22 is designed to determine, based on the data from the ultrasonic sensor 78, the body part 28 to which the currently treated flat body area 10 belongs.The ultrasound sensor 78 is designed to detect at least part of a bony structure 80 or bone and / or cartilage lying below a surface of the flat body area 10 during a treatment phase 18, 20 of the treatment.

[0094] The processing unit 22 is designed to create a visualization of the bony structure 80 located beneath the planar body area 10, based on the data from the ultrasound sensor 78. Alternatively, the processing unit 22 can be designed to calculate a visualization of the bony structure 80 located beneath the planar body area 10, independently of the data from the ultrasound sensor 78, based on the 3D position data 30, 32 of the applicator unit 12 and / or based on the surface approximation 34. The display unit 86 is designed to visually output at least the determined bony structure 80. The display unit 86 is designed to output the determined bony structure 80 as an augmented reality display. The applicator unit 12 has a compliance sensor 82. The compliance sensor 82 is designed to measure the compliance of tissue touched by the therapy head 14 in the flat body area 10.The computing unit 22 is designed to adjust the depth of a layer of the bony structure 80 below the planar body area 10 when calculating the visualization of the bony structure 80 lying below the planar body area 10 depending on the measurement data of the compliance sensor 82.

[0095] Figure 4 shows a schematic representation of one of the 3D initial models 26 underlying the treatment using the therapy system 58 and a surface approximation 34 created on the basis of this 3D initial model 26 using 3D position data 30, 32 of a tracking system 16 of the applicator unit 12.

[0096] Figure 5 shows a schematic flowchart of a procedure for operating the therapy system 58. In at least one procedure step 100, a body part 28 is provided by a living being to be treated. The body part 28 may have a wound area 60 in a treatable, flat body region 10. In at least one further procedure step 110, a 3D output model 26 is obtained from the processing unit 22. The 3D output model 26 can be retrieved from the storage unit 24 in a sub-step 111 of procedure step 110. The 3D output model 26 can be transferred to the processing unit 22 by the treating user via the user interface 84 in a sub-step 112 of procedure step 110. As an alternative to obtaining the 3D output model 26, the 3D output model 26 can be created in a process step 120 by the output model creation device 68.In sub-step 121 of process step 120, a recording of the body part 28 to be examined is generated using camera 54, or an image of the body part 28 to be examined is obtained via interface 98. In a further sub-step 122 of process step 120, the evaluation module 72 calculates the 3D output model 26 from the image / recording. The evaluation module 72 applies the machine learning algorithm and / or a photometric method for this purpose.

[0097] In at least one further process step 130, initial 3D reference position data points 64, 90 are detected and located on the planar body area 10. In a sub-step 131 of process step 130, the wound area 60 is automatically detected by the processing unit 22 through an evaluation of images from one of the cameras 54, 70 and / or manually determined using the applicator unit 12. In a sub-step 132 of process step 130, several 3D reference position data points 64, 90 are defined at the edges of the wound forming the wound area 60 based on the detected wound areas 60. For this purpose, the applicator unit 12 can be moved to the locations of the 3D reference position data points 64, 90 in order to determine the corresponding 3D positions using the tracking unit.In a further process step 140, based on the determined and / or recognized 3D reference position data points 64, 90, the area of ​​the body 10 to be treated and / or the body part 28 to be treated of the organism is automatically recognized / identified. In a sub-step 141 of process step 140, standardized and / or optimized treatment parameters for the application of the shock waves are proposed depending on the recognition of the area of ​​the body 10, in particular the body part 28, to which the applicator unit 12 is currently attached. In an alternative sub-step 142 of process step 140, the standardized and / or optimized treatment parameters (e.g.,The energy level, pulse rate, and total number of pulses for the application of the shock waves are automatically set and / or automatically adjusted, or manually set by the user, depending on the detection of the planar body area 10, in particular the body part 28, to which the applicator unit 12 is currently attached. In a further process step 150, based on the determined and / or detected 3D reference position data points 64, 90, the 3D output model 26 of the planar body area 10 and / or the body part 28 to be treated of the living being is automatically aligned in digital space relative to the actual position of the body part 28 in real space.

[0098] In at least one optional process step 160, the adapted 3D output model 62 can be generated by the computing unit 22. The adapted 3D output model 62 can be calculated as a 3D parameter surface from the multiple 3D reference position data points 64, 90. In at least one further optional process step 170, a previously created adapted 3D output model 62 of an uninjured side of body part 28 can be transferred to an injured side of body part 28, in particular by mirroring. In at least one further process step 180, the shock waves are applied to the planar body area 10 using the therapy head 14 of the applicator unit 12. In sub-step 181 of process step 180, a comparison is made between currently determined 3D position data 30, 32 and the determined 3D reference position data points 64, 90 respectively.The wound area 60 checks whether the therapy head 14 is currently in contact with a treatment area or not. If the therapy head 14 is in contact with the treatment area (e.g., within wound area 60), the application of the shock waves is enabled in a further sub-step 182 of procedure step 180. If the therapy head 14 is outside the treatment area (e.g., outside wound area 60), the application of the shock waves is disabled in a further sub-step 183 of procedure step 180. During the determination of the 3D reference position data points 64, 90 and / or the adapted 3D output model 62 (and also later during the application of the shock waves), the camera 70 of the mobile device 74 takes pictures of the treated area of ​​the body 10.During the determination of the 3D reference position data points 64, 90 and / or the adapted 3D output model 62 (and also later during the application of the shock waves), the ultrasound sensor 78 records data from the treated planar body area 10. In a process step 190, the processing unit 22 determines the location of the planar body area 10, the extent of the planar body area 10, and / or the characteristic body feature 76 within the planar body area 10, based on the recorded images and / or the data from the ultrasound sensor 78. In the same process step 190, the processing unit 22 also determines the bony structure 80 of the body part 28 located below the surface of the planar body area 10, based on the recorded data from the ultrasound sensor 78.In a further process step 200, the computing unit 22 determines, based on the recorded data from the ultrasound sensor 78, the body part 28 to which the currently treated flat body area 10 belongs.

[0099] In at least one further process step 210, the tracking system 16 determines the instantaneous 3D position data 30, 32 of the applicator unit 12 during treatment sections 18, 20. For the conversion of the localization measurement data of the tracking element 42 integrated in the applicator unit 12 into treatment points of the therapy head 14, the corresponding 3D position data 30, 32 and the geometric relationship between the tracking element 42 and the therapy head 14 are retrieved and applied. In at least one further process step 220, the processing unit 22 generates a point cloud 66 from the acquired 3D position data 30, 32.

[0100] In at least one further process step 230, based on the 3D position data 30, 32 acquired by means of the tracking system 16, the surface approximation 34 of the body part 28 with the treated planar body area 10 is calculated from the 3D source model 26 or from the adapted 3D source model 62. The surface approximation 34 is calculated based on the point cloud 66 using suitable algorithms programmed into the processing unit 22 or retrievable from the storage unit 24. The surface approximation 34 deviates at least locally from the 3D source model 26 and from the adapted 3D source model 62. The surface approximation 34 is calculated in such a way that the 3D source model 26 of the body part 28 or the adapted 3D source model 62 is approximated by the surface approximation 34.The adapted 3D output model 62 of the body part 28, which in particular represents a parameterized 3D output surface model, is adapted, at least in the planar body region 10, such that the received 3D position data 30, 32 lie with a minimal error (e.g., with respect to a distance or perpendicular to a data point originally determined by the tracking system) on a surface of the surface approximation 34, which in particular represents a parameterized 3D approximation surface model formed by a modification of the 3D output surface model (see Fig. 6). The extent of the change to local geometric surface properties of the 3D output surface model is limited by software. Outliers in position data, in particular in the 3D position data 30, 32, are preferably corrected or eliminated by the processing unit 22.

[0101] In at least one further process step 240, the tracking system 16 additionally determines and preferably stores the 3D orientations 88 of the applicator unit 12 during the multiple treatment sections 18, 20 of the treatment of the flat body area 10. In at least one process step 250, settings of the applicator unit 12 and / or shock wave parameters, preferably 3D pressure distributions of shock waves at a depth below the flat body area 10 or in a plane of the flat body area 10, are stored during the multiple treatment sections 18, 20 of the treatment of the flat body area 10.

[0102] In at least one process step 260, the 3D position data 30, 32 associated with individual treatment sections 18, 20 of the treatment are assigned to the surface points 36, 38 of the surface approximation 34. In at least one process step 270, the 3D orientations 88 associated with individual treatment sections 18, 20 of the treatment are assigned to the surface points 36, 38 of the surface approximation 34. In at least one process step 280, the settings of the applicator unit 12 and / or shock wave parameters associated with individual treatment sections 18, 20 of the treatment are assigned to the surface points 36, 38 of the surface approximation 34.In at least one process step 290, the 3D position data 30, 32 of the individual treatment sections 18, 20 assigned to the surface points 36, 38 of the surface approximation 34, and a 3D parameter surface representing the surface approximation 34, are stored on the storage unit 24 in a patient-specific manner. In at least one process step 300, the determined 3D orientations 88 and / or set treatment parameters for each surface point 36, 38 of the surface approximation 34, to which 3D position data 30, 32 from one of the individual treatment sections 18, 20 are assigned, are stored on the storage unit 24 in a patient-specific manner.

[0103] In at least one further process step 310, the 3D position data 30, 32 of the individual treatment sections 18, 20 assigned to the surface points 36, 38 of the surface approximation 34 and / or a 3D parameter surface representing the surface approximation 34 are graphically displayed via the external display unit 86 (see Figures 7 and 8). In process step 310 or in a separate further process step (not included in the diagram of Fig. 5), the visualization of the bony structure 80 lying below the planar body area 10 is also created using the data from the ultrasound sensor 78. Alternatively, the visualization of the bony structure 80 lying below the planar body area 10 can be calculated using the determined surface approximation 34. Preferably, the determined bony structure 80 is visually output as an augmented reality display (see Fig. 2).

[0104] In a further process step 320, in order to carry out and / or enable a comparison of two or more than two treatments of the same planar body region 10 of the same organism, SD parameter surfaces of surface approximations 34 and / or surface points 36, 38 of the surface approximations 34 of treatment sections 18, 20 of the two or more than two different treatments of the same planar body region 10 of the same organism are aligned (see Fig. 8). In this context, "aligning" means in particular that the surface approximations 34 are synthesized into a single surface and the further position and treatment data are then assigned to the correct points on this surface.

[0105] In a further procedural step 330, swellings and / or reductions of at least parts of the flat body area 10 are determined by comparing the SD parameter areas of the surface approximations 34 and / or the surface points 36, 38 of the surface approximations 34 of the treatment sections 18, 20 of the two or more than two different treatments of the same flat body area 10 of the same living being.

[0106] 10. Large body area

[0107] 12 applicator units

[0108] 14 Therapy head

[0109] 16 Tracking system

[0110] 18 Treatment phase

[0111] 20 Treatment phase

[0112] 22 computing units

[0113] 24 storage units

[0114] 26 3D source model

[0115] 28 Body part

[0116] 30 3D position data

[0117] 32 3D position data

[0118] 34 Surface approximation

[0119] 36 Surface point

[0120] 38 Surface point

[0121] 40 Reference point

[0122] 42 Tracking element

[0123] 44 electromagnetic tracking device 46 robot arm

[0124] 48 Angle encoders

[0125] 50 markers

[0126] 52 Optical sensor device

[0127] 54 Camera

[0128] 56 tracking sensor

[0129] 58 Therapy system

[0130] 60 wound area

[0131] 62 Adapted 3D output model

[0132] 64 3D reference position data points

[0133] 66 point cloud

[0134] 68 Initial Model Creation Device Camera

[0135] Evaluation module

[0136] Mobile device

[0137] Characteristic body feature: ultrasound sensor

[0138] bony structure compliance sensor user interface display unit

[0139] 3D alignment

[0140] 3D reference position data point, wave generation unit, further tracking element, inertial sensor

[0141] interface

[0142] EMP protection device

[0143] - 110 process steps

[0144] - 112 sub-steps of the procedure

[0145] - 122 sub-steps of the process step

[0146] - 132 sub-steps of the process step

[0147] - 142 sub-steps

[0148] - 180 process steps

[0149] - 183 partial steps

[0150] - 330 process steps

Claims

Claims 1. Therapy system (58) for a non-surgical, preferably non-invasive, treatment of at least one flat body area (10) of a living being, with an applicator unit (12), preferably manually and / or robotically controllable, comprising a therapy head (14) for the application of propagating physical therapeutically effective waves, in particular pressure waves, preferably shock waves, on the flat body area (10), and comprising a tracking system (16) which is at least designed to determine instantaneous 3D position data (30, 32) of the applicator unit (12), in particular the therapy head (14) of the applicator unit (12), during several treatment phases (18, 20) of the treatment of the planar body area (10), characterized by a computing unit (22) with access to a storage unit (24) in which at least one 3D output model (26) of a body part (28) of a living being, in particular of at least the same species as the living being to be treated, is stored, wherein the computing unit (22) is designed to receive the 3D position data (30, 32) of the applicator unit (12) acquired by the tracking system (16), and based on the received 3D position data (30, 32) generates a function originating from the 3D output model (26), and in particular differing at least locally from the 3D source model (26),2. Therapy system (58) according to claim 1, characterized in that the tracking system (16) is designed to determine the 3D position data (30, 32) for a fixed reference point (40) that is not necessarily in a fixed relative relationship to the organism being treated.

3. Therapy system (58) according to claim 1 or 2, characterized in that the tracking system (16) has at least one tracking element (42) which is integrated into the applicator unit (12) or is attached externally to the applicator unit (12), wherein a geometric relation between the tracking element (42) and the therapy head (14) required for a conversion of localization measurement data of the tracking element (42) into treatment points of the therapy head (14) corresponding to 3D position data (30, 32) is programmed into the computing unit (22) or is stored on the storage unit (24) for the computing unit (22) in a retrievable manner.

4. Therapy system (58) according to one of the preceding claims, characterized in that the tracking system (16) is additionally provided for determining the 3D position data (30, 32) to determine 3D orientations (88) of the applicator unit (12), in particular of the therapy head (14), during the several treatment sections (18, 20) of the treatment of the planar body area (10), and preferably to assign them to the respective associated surface points (36, 38) of the surface approximation (34). 5.Therapy system (58) according to one of the preceding claims, characterized in that the applicator unit (12) is provided to store settings of the applicator unit (12) and / or parameters of the emitted physical therapeutically effective waves, in particular shock wave parameters, preferably 3D pressure distributions of shock waves at a depth below the planar body area (10) or in a plane of the planar body area (10), during the several treatment sections (18, 20) of the treatment of the planar body area (10) and to assign them to the respective associated surface points (36, 38) of the surface approximation (34).

6. Therapy system (58) according to one of the preceding claims, characterized in that the tracking system (16) at least comprises an electromagnetic tracking device (44).

7. Therapy system (58) according to one of the preceding claims, in particular at least according to claim 6, characterized by an EMP protection device (99) which is provided to protect at least one electromagnetic sensor of a component of the therapy system (58), in particular the electromagnetic tracking device (44), from the effects of electromagnetic pulses (EMP), which may arise in particular during the generation of the physical therapeutically effective waves.

8. Therapy system (58) according to one of the preceding claims, characterized in that the tracking system (16) has at least one angle encoder (48) integrated in a multi-axis bearing arm or robot arm (46), is configured as a multi-axis bearing arm or robot arm (46) with an integrated angle encoder (48), or as a tethered tracking system, for example, a tethered fiber optic tracking system.

9. Therapy system (58) according to one of the preceding claims, characterized in that the tracking system (16) has a marker (50) mounted on or attached to the applicator unit (12), which can be detected and tracked by an optical sensor device (52), such as a camera system or a laser scanner system, etc.

10. Therapy system (58) according to one of the preceding claims, characterized in that the tracking system (16) has at least one camera (54) or is designed as a camera (54) which is intended to determine the instantaneous 3D position data (30, 32) of the applicator unit (12) at least partially on the basis of image processing.

11. Therapy system (58) according to one of the preceding claims, characterized in that the tracking system (16) comprises one or more of the following tracking sensors (56): Accelerometer, angular acceleration sensor, geomagnetic field sensor, gravitational sensor.

12. Therapy system (58) according to one of claims 6, 8, 10 or 11, characterized in that the tracking system (16) is provided to determine the instantaneous 3D position data (30, 32) of the applicator unit (12) at least partially on the basis of a sensor combination of at least two of the tracking sensors (56) mentioned in claims 6, 9 or 10.

13. Therapy system (58) at least according to claims 9 and 11, characterized in that the tracking system (16) is provided to determine the instantaneous 3D position data (30, 32) of the applicator unit (12) at least partially on the basis of a combination of data from a marker tracking carried out by the optical sensor device (52) and data from at least one of the tracking sensors (56) mentioned in claim 10.

14. Therapy system (58) according to one of the preceding claims, characterized in that the computing unit (22) is provided for calculating the surface approximation (34) such that the 3D output model (26) of the body part (28), which in particular represents a parameterized 3D output surface model, is adapted at least in the planar body area (10) such that the received 3D position data (30, 32) lie with a minimal error on a surface of the surface approximation (34), which in particular represents a parameterized 3D approximation surface model formed by a modification of the 3D output surface model, wherein preferably the strength of a change of at least one local geometric surface property, for example a surface shape, of the 3D output surface model is limited by software. 15.Therapy system (58) according to one of the preceding claims, characterized in that the computing unit (22) is provided to identify wound areas (60) on the flat body area (10) to be treated, using camera images from an external or internal camera (54) to the therapy system (58).

16. Therapy system (58) according to claim 15, characterized in that the computing unit (22) is provided to define 3D reference position data points (64, 90) in an environment of the wound area (60) or at edges of a wound forming the wound area (60) based on the detected wound areas (60) and preferably to use these data in the therapeutic treatment in order to be able to treat only in the direct or indirect wound area (60).

17. Therapy system (58) according to one of the preceding claims, in particular according to claim 16, characterized in that the computing unit (22) is provided to start from an adapted 3D output model (62) when calculating the surface approximation (34), which is adapted in comparison to the 3D output model (26) retrieved by the storage unit (24) by 3D reference position data points (64) that are initially defined or determined before / at the beginning of the treatment, in particular automatically by means of a camera (54) or the like and / or manually by means of the applicator unit (12). 18.Therapy system (58) according to one of the preceding claims, characterized in that the computing unit (22) is provided to start from an adapted 3D initial model (62) of this side of the body part (28) when calculating the surface approximation (34) of a wounded side of a body part (28), which is generated by a transfer and / or mirroring of an already generated surface approximation (34) or an adapted 3D initial model (62) of an unwounded side of the same body part (28) or of another body part of the living being that is similar to the body part (28).

19. Therapy system (58) according to one of the preceding claims, characterized in that the computing unit (22) is provided to form a point cloud (66) from the received 3D position data (30, 32) and to calculate the surface approximation (34) based on this point cloud (66) by means of a suitable algorithm programmed into the computing unit (22) or retrievable from the storage unit (24).

20. Therapy system (58) according to claim 17, characterized in that the algorithm is a Hoppes algorithm, a power crust algorithm, a Gaussian splatting algorithm, an alpha shapes algorithm, a Delauny triangulation algorithm, a ball pivoting algorithm, a Poisson surface reconstruction algorithm, a marching cubes algorithm, an advancing front algorithm, a radial basis function algorithm, a moving least squares algorithm, or a scale space algorithm. 21.Therapy system (58) according to one of the preceding claims, characterized by an output model creation device (68), comprising at least one camera (54) for recording at least one image of the body part (28) of the living being or of another living being of the same species or an interface (98) for receiving at least one image of the body part (28) of the living being or of another living being of the same species and comprising at least one computing unit, in particular the computing unit (22), which has at least one evaluation module (72) trained using real body data, which is configured at least for creating the 3D output model (26) at least on the basis of the at least one image.

22. Therapy system (58) according to claim 21, characterized in that the creation of the 3D output model (26) based on the at least one image by the evaluation module (72) comprises a photometric method.

23. Therapy system (58) according to claim 21 or 22, characterized in that the evaluation module (72) comprises a machine learning algorithm which is designed to receive at least one image as input and is trained to output a 3D output model (26) of the body part (28) depicted in the at least one image, which is designed as a correspondingly adapted parameterized 3D output surface model.

24. Therapy system (58) according to one of the preceding claims, characterized by at least one camera (70) which is integrated into the applicator unit (12), mounted on the applicator unit (12), or designed separately from the applicator unit (12) and arranged remotely, wherein the camera (70) is designed to record at least one image of the treated planar body area (10) during at least one treatment phase (18, 20) of the treatment.

25. Therapy system (58) according to claim 24, characterized in that the camera (70), which is designed separately from the applicator unit (12) and is arranged remotely, is part of a mobile device (74), e.g. a smartphone or a tablet or the like, which does not form a fixed component of the therapy system (58), but can transmit image data, at least comprising the image, to the therapy system (58), in particular the computing unit (22), via an interface (98).

26. Therapy system (58) according to claim 24 or 25, characterized in that the computing unit (22) is provided for determining, on the basis of at least the recorded image, a position of the planar body area (10), an extent of the planar body area (10) and / or at least one characteristic body feature (76) within the planar body area (10). 27.Therapy system (58) according to one of the preceding claims, characterized in that the applicator unit (12) has at least one integrated or mounted ultrasound sensor (78) which is provided to detect at least a part of a surface of the planar body area (10) during at least one treatment phase (18, 20) of the treatment, wherein the computing unit (22) is provided to determine, on the basis of the data from the ultrasound sensor (78), a position of the planar body area (10), an extent of the planar body area (10) and / or at least one characteristic body feature (76) within the planar body area (10).

28. Therapy system (58) according to one of the preceding claims, characterized in that the applicator unit (12) has an integrated or mounted ultrasound sensor (78) which is provided to detect at least a part of a bony structure (80) lying below a surface of the planar body area (10) during at least one treatment phase (18, 20) of the treatment.

29. Therapy system (58) according to claim 28, characterized in that the computing unit (22) is provided to determine, on the basis of the data from the ultrasound sensor (78), the body part (28) to which the currently treated planar body area (10) belongs.

30. Therapy system (58) according to claim 28 or 29, characterized in that the computing unit (22) is provided for creating a visualization of the bony structure (80) lying below the planar body area (10) based on the data from the ultrasound sensor (78).

31. Therapy system (58) according to one of the preceding claims, characterized in that the computing unit (22) is provided for calculating a visualization of the bony structure (80) lying below the planar body area (10) based on the 3D position data (30, 32) of the applicator unit (12) and / or based on the surface approximation (34).

32. Therapy system (58) according to claim 31, characterized in that the applicator unit (12) has a compliance sensor (82) which is provided to measure a compliance of a tissue touched by the therapy head (14) in the planar body area (10), wherein the computing unit (22) is provided to adjust at least a depth of a layer of the bony structure (80) below the planar body area (10) when calculating the visualization of the bony structure (80) lying below the planar body area (10) depending on measurement data of the compliance sensor (82).

33. Therapy system (58) according to one of the preceding claims, characterized in that the computing unit (22) has a user interface (84) which is designed to receive input from the user indicating which body part(s) (28) are to be treated, wherein the computing unit (22) is designed to select, depending on the user's input, the 3D output models (26) suitable for the following treatment sections (18, 20) for creating the surface approximation (34).

34. Therapy system (58) according to claim 30 or 31, characterized by a display unit (86) or a visualization output interface for an external display unit (86), wherein the display unit (86) is designed to visually output at least the determined bony structure (80), preferably as an augmented reality display.

35. Therapy system (58) according to one of the preceding claims, in particular according to one of claims 15 to 16 or 26 to 29, characterized in that the computing unit (22) is configured to enable or disable the application of the propagating physical therapeutically effective waves depending on a detection by the therapy system (58) of the planar body area (10), in particular the body part (28) on which the applicator unit (12) is currently in contact and / or depending on a position of the therapy head (14) relative to a wound area (60) on the planar body area (10) to be treated, and / or depending on an orientation of the therapy head (14) relative to the planar body area (10) to be treated.

36. Therapy system (58) according to one of the preceding claims, characterized in that the computing unit (22) is configured to suggest, automatically set and / or automatically adjust, in particular standardized and / or optimized, treatment parameters for the application of the propagating physical therapeutically effective waves depending on a detection by the therapy system (58) of the planar body area (10), in particular body part (28), on which the applicator unit (12) is currently in contact. 37.Therapy system (58) according to one of the preceding claims, characterized in that the computing unit (22) is configured to store at least the 3D position data (30, 32) of the individual treatment sections (18, 20) assigned to the surface points (36, 38) of the surface approximation (34) and a 3D parameter surface representing the surface approximation (34) on the storage unit (24) or on another storage unit, preferably patient-specific.

38. Therapy system (58) according to claim 37, characterized in that the computing unit (22) is configured to store determined 3D orientations (88) and / or set treatment parameters for each surface point (36, 38) of the surface approximation (34), to which 3D position data (30, 32) from one of the individual treatment sections (18, 20) are assigned, on the storage unit (24) or on another storage unit, preferably patient-specific.

39. Therapy system (58) according to claim 37 or 38, characterized in that the computing unit (22) is configured, in particular for carrying out and / or enabling a comparison of two or more than two treatments of the same planar body area (10) of the same organism or of two different organisms of the same species, to bring into agreement 3D parameter surfaces of surface approximations (34) of the two or more than two different treatments of the same planar body area (10) of the same organism or of two different organisms of the same species. 40.Therapy system (58) according to claim 39, characterized in that the computing unit (22) is configured to detect swelling and / or reduction of swelling of at least parts of the flat body area (10) by comparing the 3D parameter surfaces of surface approximations (34) of the two or more than two different treatments of the same planar body area (10) of the same living being.

41. Therapy system (58) according to one of the preceding claims, characterized in that the computing unit (22) is configured to graphically display at least the 3D position data (30, 32) of the individual treatment sections (18, 20) assigned to the surface points (36, 38) of the surface approximation (34) and / or a 3D parameter surface representing the surface approximation (34) via a display unit of the therapy system (58) or via an external display unit (86).

42. Method for operating a therapy system (58), in particular according to one of the preceding claims, which is provided for non-surgical, preferably non-invasive, treatment of at least one planar body region (10) of a living being by means of an applicator unit (12), preferably manually and / or robotically guided. wherein propagating physical therapeutically effective waves, in particular pressure waves, preferably shock waves, are applied to the flat body area (10) by means of a therapy head (14) of the applicator unit (12), and wherein instantaneous 3D position data (30, 32) of the applicator unit (12), in particular of the therapy head (14) of the applicator unit (12), are determined by means of a tracking system (16) during several treatment phases (18, 20) of the treatment of the planar body area (10), characterized in that a 3D initial model (26) of a body part (28) of a living being, in particular of at least the same species as the living being to be treated, is retrieved from a storage unit (24), based on the 3D position data (30, 32) acquired by means of the tracking system (16), and in particular deviating at least locally from the 3D initial model (26), a surface approximation (34) of the body part (28) with the planar body area (10) undergoing treatment is calculated, and the individual Treatment sections (18, 20) of the treatment associated 3D position data (30, 32) surface points (36,38) of the surface approximation (34).

43. Method according to claim 42, characterized in that during the treatment, in particular at the beginning of the treatment, at least one 3D reference position data point (64) on the living being, in particular within the planar body area (10), is determined by means of the applicator unit (12).

44. Method according to claim 42 or 43, characterized in that during the treatment, in particular at the beginning of the treatment, at least one 3D reference position data point (64) on the living being, for example a wound area (60), is automatically detected.

45. Method according to claim 43 or 44, characterized in that during the treatment, in particular at the beginning of the treatment, at least two, preferably at least three, 3D reference position data points (64, 90) are determined by means of the applicator unit (12) and / or are automatically recognized, and that based on the determined and / or recognized 3D reference position data points (64, 90) a 3D parameter surface forming an adapted 3D output model (62) is calculated.

46. ​​A method according to any one of claims 43 to 45, characterized in that, based on the determined and / or recognized 3D reference position data points (64, 90), the planar body area (10) and / or the body part (28) to be treated of the living being is automatically recognized.

47. A method according to any one of claims 43 to 46, characterized in that, based on the determined and / or recognized 3D reference position data points (64, 90), the 3D output model (26) of the planar body area (10) and / or the body part (28) to be treated of the living being is automatically digitally aligned.

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