Integrated therapy chain

Abstract

The present invention relates to a system of an integrated therapy chain (1) for planning and carrying out an insertion of a predetermined implant system, the therapy chain (1) comprising preoperative, intraoperative and postoperative therapy steps (S1, S2, S3, S4, S5), comprising: a first data device (2) for gathering, processing and providing patient-specific kinematic data (9, 10, 11, 12, 15, 16, 22, 23), a second data device (3) for gathering, processing and providing patient data (7, 8), a third data device (5) for storing and providing data of the predetermined implant system (17, 18, 19), and a control unit (6) for controlling the data devices (2, 3, 4, 5) and for carrying out the therapy steps (S1, S2, S3, S4, S5) on the basis of the aforementioned data (9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23). The first data device (2) is provided and designed to provide at least a first data set and a second data set, the first data set comprising the currently gathered, patient-specific kinematic data (9, 10, 11), the second data set comprising historical data (12) based on older insertions of the predetermined implant system, which historical data have been stored similarly to the currently gathered, patient-specific kinematic data, and the second data set being designed and provided to supplement the first data set. The present invention also relates to a method for the preoperative preparation of an operation to insert an implant system.

Description

[0001] Integrated Therapy Chain Description Technical Field The present disclosure relates to a system of an integrated therapy chain for planning and implementing the use of a predetermined implant system, wherein the therapy chain comprises pre-, intra-, and postoperative therapy steps. Furthermore, the present disclosure relates to a method for preoperative preparation of an operation for inserting an implant system. Background of the Disclosure Currently, in surgical planning, for example, a total endoprosthesis,In particular, for total knee replacements, only X-rays, CT scans, or MRI images are used. A qualitative examination of joint function is usually performed beforehand by the attending physician. Therefore, preoperative planning for procedures of this type is currently based solely on the patient's anatomical conditions or anatomy on the one hand, and the implant dimensions on the other. The patient's weight restrictions defined by the manufacturer for specific implant sizes must be taken into account here. However, specifying a weight limit as the sole parameter for implant selection is often too one-sided and imprecise. This often leads to patient discomfort after implantation, as the implant does not correctly and comprehensively meet the patient's requirements.In particular, the mechanical limits are frequently exceeded and can lead to serious complications downstream. In other words, a suboptimal alignment or a suboptimal implant type leads to a failure to restore or restore functionality and can therefore lead to pain, especially if optimal adaptation to the patient's soft tissue situation is not achieved. Therefore, it is often a disadvantage that in most treatment cases, the specific characteristics and limitations of the implant system used cannot be taken into account. In particular, the interplay between patient-specific, non-influenceable conditions and the implant system used is not considered in detail. This is primarily due to the fact that the physician currently has no information available to assess whether his alignment technique, which empirically appears to work well,is mechanically safe and therefore also the better or best solution in the long term. This is particularly relevant in that not all patients require the same treatment, and some factors, especially during surgery or rehabilitation, can only be reacted to rather than acted upon. Brief description of the disclosure It is the objective technical object of the present disclosure to provide a system of an integrated therapy chain, which essentially takes into account all, or at least the calculable, eventualities, in order to improve the patient-specific care before, during and after the operation / procedure and to increase patient satisfaction. A further object isto eliminate or at least mitigate the disadvantages of the prior art. The above object is achieved by the subject matter of claim 1. Specifically, the above object is achieved by an electronic system (device) with an integrated therapy chain for planning and implementing the use of a predetermined or selectable implant system, preferably in a knee endoprosthesis, shoulder endoprosthesis, or hip endoprosthesis, wherein the therapy chain comprises pre-, intra-, and postoperative therapy steps. The selection of the implant system can be part of the therapy chain. Based on data, e.g., patient kinematics, implant boundaries, simulation, and other boundary conditions, the best implant system and the best implant type for the patient can be selected. Alternatively, the term implant system can also include a cruciate ligament to be inserted,a tibial osteotomy or the like. The disclosed electronic system (device) has a first data device for acquiring, processing, and providing patient-specific kinematic data, a second data device for acquiring, processing, and providing patient data, preferably a fourth data device for storing, processing, and providing image material, a third data device for storing and providing data of the specific implant system or of a number of selectable implant systems / implant systems, and a control unit for controlling the data devices and for carrying out the therapy steps based on the above data. The first data device (2) is provided and designed to provide at least a first and a second data set, wherein the first data set comprises the currently acquired patient-specific kinematic data.the second data set contains similar historical data based on previous applications of the specific / selectable implant system to the currently recorded patient-specific kinematics data, and the second data set is designed and intended to supplement the first data set with empirical values ​​from the historical data. In other words, the present disclosure relates to a technical / electronic solution for an integrated therapy chain for improving patient-specific treatment with a total endoprosthesis, preferably a knee endoprosthesis, as well as the subsequent rehabilitation measures. This solution records and considers both preoperative, intraoperative, and postoperative patient-specific data. Preoperatively, the selection of the optimal surgical time can also be part of the therapy chain. Based on the diagnosis, the degree of arthrosis,The optimal time (not too early, but also not too late) can be determined based on the patient's muscular and coordination status, as well as other parameters. Likewise, potentially beneficial pre-rehabilitation measures can be identified as preparation for the surgery and to accelerate postoperative rehabilitation. This means that, in contrast to the state of the art and within the framework of orthopedic surgical planning, patient-specific kinematics, demographic data (of the patient), and surgical results from previous, comparable cases are taken into account (included) in order to also consider the specificity and limitations of the implant system to be used. Against this background, the present disclosure pursues an integrative approach in which the necessary data for or relating to the individual patient is collected, processed, and provided step by step. This means,that the patient-specific information is supplemented / optimized / enriched with empirical values ​​from previous, comparable cases. This involves investigating which preoperative planning and intraoperatively implemented implant selection and implant position have achieved the best results in comparable patients to date. In addition, potential risks for the therapy (e.g. duration of anesthesia) and the implant (e.g. body weight) resulting from the medical history are identified and options for risk minimization are presented. This includes, among other data, the pre-, intra-, and postoperative recording of the patient-specific kinematics using suitable methods known from the prior art. Further aspects of the present disclosure are defined in the subclaims and described in more detail below. It is advantageous if the pre-, intra-, and postoperative,Patient-specific data can be gradually combined, enhanced / supplemented, and used to optimize therapy across system boundaries. "Supplemented / supplemented" means that the existing data is supplemented or enhanced with existing, particularly comparable, data in order to incorporate experience from previous cases into the planning and execution of the operation. It is preferred if the preoperative therapy steps include performing an intelligent mobility analysis to capture patient-specific kinematic data, planning, and simulation of the implant system deployment, the intraoperative therapy step includes implementing the implant system deployment, and the postoperative therapy step includes rehabilitation. It is advantageous if the preoperative therapy step includes intelligent mobility analysis, preferably gait analysis.is provided and configured to record the patient-specific kinematic data and the patient data and to process them in the corresponding data devices. It is advantageous if the first data device is provided and configured to determine a kinematics and a phenotype from the patient-specific kinematic data. From the patient-specific kinematic data, the patient's phenotype, demographic data, and information about previous illnesses, as well as their individual requirement profile, such as sports, everyday life, and work activity, can be derived. It is preferred if the system has a fourth data device for storing, processing, and providing image material. In this case, it is advantageous if the preoperative therapy step of the intelligent mobility analysis is provided and configured toto also capture the image material and process it in the corresponding data device. It is preferred if the preoperative therapy step of planning for inserting the implant system is provided and designed to determine at least the implant type and the implant size based on the processed data from the first, second and fourth data devices and the data from the third data device. In other words, with the preceding holistic consideration of the case, a surgical plan is carried out with regard to implant selection and implant positioning. It is advantageous if the fourth data device is provided and designed to determine a bone morphology based on the image material. It is advantageous if the preoperative therapy step of simulation for inserting the implant system is provided and designed to, based on the preceding planning,Bone morphology and implant alignment are used to test the mechanical limits of the predetermined implant system. In this subsequent simulation, the resulting planning is reviewed, taking into account the available patient data and the mechanical limits of the planned implant system. It is advantageous if the simulation is designed and configured to apply loads to the implant that correspond to the patient's kinematics, taking into account their body weight, anatomy, kinematic phenotype, and the implant planning previously prepared by the physician. If the mechanical limits of the implant system are not exceeded at any time during the loading cycle, the planning is released for intraoperative implementation. Otherwise, it is preferred if the simulation shows that the mechanical limits were exceeded at least once.The system makes suggestions for changes to the planning, with the aim of adhering to the mechanical limits of the implant system and, ideally, reconstructing the kinematics in such a way as to achieve the highest patient satisfaction for this phenotype. It is preferred if the intraoperative therapy step of inserting the predetermined implant system is designed and configured to implement the planning based on the simulation using a navigation or robotic system. In other words, the planning is subsequently implemented intraoperatively using a navigation or robotic system. The planning can also be integrated as part of the navigation / robotic system. This has the effect ofthat intraoperative circumstances and, for example, the patient's individual soft tissue situation can be addressed in the simulation. An intraoperative change of the implant system can also be taken into account in this way. It is advantageous if the postoperative therapy step for the implementation of rehabilitation can be adapted accordingly based on the patient's individual kinematics data, the initial data security, and a preoperative requirement profile. Based on the knowledge of the patient's individual kinematics and the preoperative requirement profile, the subsequent rehabilitation measures can be adapted accordingly. Using intelligent movement analysis, especially gait analysis, the rehabilitation can be tracked, even remotely.supervised and individualized. The data from rehabilitation as well as the patient's postoperative kinematics can in turn be recorded and used to optimize the further simulation model and preoperative planning. This allows the system to be continuously monitored and improved. Furthermore, the present disclosure relates to a method for preoperative preparation of an operation to insert an implant system, comprising the following steps: - recording patient-specific data, in particular kinematic data, general patient data, and patient-specific image material (S1); - enriching the patient-specific data, in particular kinematic data, with comparison data; - determining a phenotype of the patient based on the patient-specific data,in particular the kinematic data; - Carrying out planning regarding implant selection and implant positioning based on the enriched patient-specific data and the information on the implant system (S2); and - Carrying out a simulation to verify the planning regarding the mechanical limits of the implant system, taking into account the patient-specific data (S3); - Approval of the preoperative planning if the mechanical limits of the implant system have not been exceeded or suggestions for plan changes in order to comply with the mechanical limits of the implant system. The same process or the above system can also be applied to the treatment of other joints, such as the hip or shoulder. Furthermore, the described application can be expanded by considering additional parameters,for example, from other joints. For example, the musculoskeletal model of the knee can be expanded to include bony structures of the ankle and hip or pelvis, as well as the corresponding muscle forces. Furthermore, applications in the field of spinal surgery are preferred. Here, too, a musculoskeletal model of individual spinal segments or even the entire spine, including the pelvis if necessary, can be used for the simulation. Furthermore, in another embodiment, conservative treatments of joint problems without the use of implants can be considered. Examples include cruciate ligament reconstruction or a tibial osteotomy. Especially in HTO (high tibial osteotomy), the simulation of the correction angle can improve the long-term outcome. In summary, one advantage of the system according to the invention is that pre- / post- and intra-operative kinematics can be considered.in order to find the best intervention solution for each individual patient. Finally, the present disclosure relates to a storage medium on which the above method steps are stored. Brief description of the figure Fig. 1 is a diagram illustrating a flow chart of the system according to an embodiment of the present disclosure. Description of the preferred embodiments A preferred embodiment of the present disclosure is described below on the basis of the associated figure. Fig. 1 is a diagram illustrating a flow chart of the system according to a preferred embodiment of the present disclosure. In a first therapy step S1 of the preoperative preparation for carrying out the use of a predetermined implant system, this involves the acquisition of various data, in particular an intelligent mobility analysis,preferably an intelligent gait analysis. In therapy step S1 according to Fig. 1, data on the patient 7 and demographics 8 are recorded in a second data device 3. In a first data device 2, mobility analysis data 9, ground reaction forces 10, EMG data 11, and comparison data 12 are recorded. In addition, in therapy step S1, X-ray images 13 and SSM (Statistical Shape Model) 14 are examined. A "Statistical Shape Model" is a static model of the bones calculated based on a large number of CT data. The SSM can replicate each bone by varying the descriptive parameters or eigenvalues. This means that if the 3D SSM is adapted to the contour from the 2D X-ray image, a very good 3D reconstruction is obtained from the 2D information. In a second therapy step S2, which concerns the planning of the implant system,Kinematics data 15 and phenotype data 16 are used. The phenotype is derived from the data of the first therapy step S1 and transferred directly to planning step S2. The data regarding kinematics 15 correspond to the data processed from the first data device 2, which was acquired in therapy step S1. Furthermore, therapy step S2 takes into account the data regarding demographics 8, which can be obtained both from the second data device 3 and directly from the first therapy step S1. The image material 13 and 14 from therapy step S1 are transferred to therapy step S2 and stored and processed in a fourth data device 4. In planning step S2, data about the implant system is also relevant. Thus, corresponding data for an implant type 17 and an implant size 18 are taken into account and stored in a third data device 5. In a third preoperative therapy step S3,which corresponds to the simulation of the use of the implant system, data regarding kinematics 15, phenotype 16, and EMG data 11 are used from the first data device 2. Data regarding the patient 7 and demographics 8 are taken into account from the second data device 3. In the fourth data device 4, the image materials 13 and 14 are processed in such a way as to provide a bone morphology 20 for the third therapy step S3. The simulation S3 takes into account the aspects of planning S2 as well as an implant orientation 19, the implant type 17, and the implant size 18. The simulation S3 provides information about the interaction of the patient's circumstances based on the patient-specific kinematic data and the mechanical limits of the planned implant system to be used. The therapy step S4 is an intraoperative step. In S4, the implant system is compared with the aspects of the implant type 17,the implant size 18 and the implant alignment 19 using the planning S2 and the simulation S3 by means of a navigation or robot system, or the operation is performed. The first data device 2 provides data on postoperative kinematics 22 and intraoperative kinematics 23 to step S4. Furthermore, data regarding the patient's soft tissue 21 are taken into account in step S4. A postoperative therapy step S5 takes into account the data on the patient 7 and the demographics 8 from the second data device 3 for rehabilitation measures, as well as data on the patient-specific kinematics 9, 10, 11, and 12 and the implant type 17 and the implant size 18. The patient-specific kinematics data for therapy step S5 are derived from the kinematics data acquired in therapy step S1, which are provided by the first data device 2.and the post- and intraoperative kinematics 22 and 23 used in therapy step S4.

[0002] List of reference symbols Integrated therapy chain First data device Second data device Fourth data device Third data device Control unit Patient Demographics Mobility analysis data Ground reaction forces EMG data History data X-ray image SSM Kinematics Phenotype Implant type Implant size Implant orientation Bone morphology Soft tissue Postoperative kinematics Intraoperative kinematics

Claims

Claims 1. System of an integrated therapy chain (1) for planning and executing the use of a specific or selectable implant system, wherein the therapy chain (1) comprises pre-, intra-, and postoperative therapy steps (S1, S2, S3, S4, S5), comprising: - a first data unit (2) for acquiring, processing, and providing current patient-specific kinematic data (9, 10, 11, 12, 15, 16, 22, 23), - a second data unit (3) for acquiring, processing, and providing current patient data (7, 8), - a third data unit (5) for storing and providing data of the specific or selectable implant system (17, 18, 19), and - a control unit (6) for controlling the data units (2, 3, 4, 5) and for executing the therapy steps (S1, S2, S3, S4, S5) based on the aforementioned data (9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23), characterized by,that the first data device (2) is designed and configured to provide at least a first and a second data set, wherein the first data set comprises the currently acquired patient-specific kinematic data (9, 10, 11), the second data set comprises similar historical data (12) based on older or previous uses of the specified or selectable implant system, and the second data set is designed and configured to supplement the first data set with empirical values ​​from the historical data (12).

2. System according to claim 1, characterized in that the preoperative therapy steps (S1, S2, S3) comprise performing an intelligent mobility analysis (S1) to acquire patient-specific kinematic data (9, 10, 11, 12, 15, 16), planning (S2), and simulation (S3) of the use of the implant system. - the intraoperative therapy step (S4) comprises the insertion of the implant system, and - the postoperative therapy step (S5) comprises rehabilitation.

3. System according to claim 2, characterized in that the preoperative therapy step (S1) of the intelligent mobility analysis, preferably gait analysis, is provided and configured to acquire the patient-specific kinematic data (9, 10, 11, 12) as well as the patient data and to process them in the corresponding data units (2, 3).

4. System according to claim 3, characterized in that the first data unit (2) is provided and configured to determine a kinematic (15) and a phenotype (16) from the patient-specific kinematic data (9, 10, 11, 12). 5.System according to one of the preceding claims, characterized in that the system comprises a fourth data unit (4) for storing, processing, and providing image data (13, 14, 20).

6. System according to claim 5, characterized in that the preoperative therapy step (S1) of the intelligent mobility analysis is designed and configured to also acquire the image data (13, 14, 20) and process it in the corresponding data unit (4).

7. System according to claim 6, characterized in that the preoperative therapy step (S2) of the planning for the insertion of the implant system is designed and configured to determine at least the implant type (17) and the implant size (18) based on the processed data (8, 13, 14, 15, 16) of the data units (2, 3, 4) and the data of the third data unit (5). 8.System according to claim 7, characterized in that the fourth data device (4) is provided and configured to determine a bone morphology (20) based on the image material (13, 14).

9. System according to claim 8, characterized in that the preoperative therapy step (S3) of the simulation for inserting the implant system is designed and configured to test the mechanical limits of the predetermined implant system based on the prior planning (S2), the bone morphology (20), and an implant orientation (19).

10. System according to claim 9, characterized in that the intraoperative therapy step (S4) for performing the insertion of the predetermined implant system is designed and configured to implement the planning (S2) based on the simulation (S3) using a navigation or robotic system.

11. System according to claim 10, characterized in that the postoperative therapy step (S5) for performing the rehabilitation is adaptable based on the patient-specific kinematic data (9, 10, 11, 12) of the first data device (2) and a preoperative requirement profile.

12. Procedure for the preoperative preparation of an operation for the insertion of an implant system, comprising the following steps: - Acquisition of patient-specific data, in particular kinematic data, general patient data and patient-specific imaging (S1); - Enrichment of the patient-specific data, in particular kinematic data, with comparative data; - Determination of a patient phenotype based on the patient-specific data, in particular the kinematic data; - Planning with regard to implant selection and implant positioning based on the enriched patient-specific data and the information on the implant system (S2); and - Performing a simulation to verify the planning with regard to the mechanical limits of the implant system, taking into account the patient-specific data (S3). - Approval of the preoperative plan if the mechanical limits of the implant system have not been exceeded, or suggestions for plan modifications to comply with the mechanical limits of the implant system.

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