EP4522024A1 - Vorrichtung und verfahren zur standardisierung der achsausrichtung und -position von kinematikdaten bezüglich eines körpergelenks eines patienten - Google Patents
Vorrichtung und verfahren zur standardisierung der achsausrichtung und -position von kinematikdaten bezüglich eines körpergelenks eines patientenInfo
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- EP4522024A1 EP4522024A1 EP23723974.4A EP23723974A EP4522024A1 EP 4522024 A1 EP4522024 A1 EP 4522024A1 EP 23723974 A EP23723974 A EP 23723974A EP 4522024 A1 EP4522024 A1 EP 4522024A1
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- kinematics
- joint
- evaluation
- patient
- standard
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/45—For evaluating or diagnosing the musculoskeletal system or teeth
- A61B5/4538—Evaluating a particular part of the muscoloskeletal system or a particular medical condition
- A61B5/4585—Evaluating the knee
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
- A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
- A61B5/112—Gait analysis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
- A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
- A61B5/1113—Local tracking of patients, e.g. in a hospital or private home
- A61B5/1114—Tracking parts of the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
- A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
- A61B5/1121—Determining geometric values, e.g. centre of rotation or angular range of movement
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
- A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
- A61B5/1126—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb using a particular sensing technique
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
- A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
- A61B5/1126—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb using a particular sensing technique
- A61B5/1127—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb using a particular sensing technique using markers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
- A61B5/7271—Specific aspects of physiological measurement analysis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
- A61B2034/108—Computer aided selection or customisation of medical implants or cutting guides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B2034/2046—Tracking techniques
- A61B2034/2048—Tracking techniques using an accelerometer or inertia sensor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B2034/2046—Tracking techniques
- A61B2034/2055—Optical tracking systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/02—Details of sensors specially adapted for in-vivo measurements
- A61B2562/0219—Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
Definitions
- the present disclosure relates to a standard kinematics evaluation system for recording, normalizing and evaluating biomechanical kinematics data of a ( selected) joint of a patient with: at least one detection device which is adapted to use sensors to detect (record) biomechanical kinematics of the patient's joint and to provide it in a computer-readable manner; and a visual display device, in particular a surgical monitor, for visual output to a user.
- the present disclosure relates to a standardization method and a computer-readable storage medium according to the preambles of the independent claims.
- the position/pose i.e. the orientation and position, but in particular the orientation itself, of the underlying reference system of each segment involved has a significant influence on the size and characteristics/properties the resulting (kinematics) curve, in particular waveforms, of three measured rotations corresponding to a specific joint connecting these segments and, if necessary, further measured translations in three spatial directions. This was previously attributed to crosstalk effects.
- Crosstalk results from incorrect alignment and further preferably incorrect positioning of the axes of the coordinate system, so that a rotation in one plane is partially perceived as a rotation in other planes.
- AE2046P-WO-0032 2022P00079 WO 2 / 35 Methods for minimizing crosstalk effects usually attempt to achieve this by minimizing one or more selected target functions for a specific activity, a measurement system, a biomechanical model. Such a minimization is described in Baker et al.1999 - A new approach to determine the hip rotation profile from clinical gait analysis data, Rivest 2005 - A correction for axis misalignment in the joint angle curves representing knee movement in gait analysis, Baudet et al .
- an object of the invention is to provide a device and a method for standardizing or normalizing an axis alignment of biomechanical kinematics data, in particular rotational kinematics data and/or AE2046P-WO-0032 2022P00079 WO 6 / 35 Translation kinematics data regarding a patient's body joint.
- the kinematics data therefore includes the translational kinematics data and/or the rotational kinematics data between two movable bodies or segments.
- the tasks are solved according to the invention with regard to a generic standardization system by the features of claim 1, with regard to a generic standardization method solved according to the invention by the features of claim 11 and with regard to a computer-readable storage medium solved according to the invention by the features of claim 14.
- a basic idea here is to provide a standardization system and standardization method for comparing kinematic patterns that does not require prior knowledge of the position/pose, i.e. the orientation and position, in particular the orientation/alignment, of the original underlying reference frames, but rather the orientation and/or positioning of the two frameworks for comparison by optimizing the value of a chosen criterion.
- the present disclosure includes a normalization or standardization method or specially adapted control units (similar to an algorithm) with which kinematic data from two or more sources (such as different experiments, different subjects, different motion capture technologies, different laboratories, and the like) can be compared can be made by processing the underlying kinematics data in such a way that at least one selected parameter is optimized.
- a valid comparison of the resulting rotation data or translation data is made possible, since differences due to axis misalignments or axis mispositioning in the at least two data sets have been or can be corrected equally.
- the present disclosure proposes an optimization of the alignment and/or positioning, i.e.
- An approach is proposed that solves this problem by providing a method or customized control unit in which one or more specific (optimization) parameters or an objective function are chosen and then each data set (of kinematics data) is processed accordingly in order to achieve the To obtain rotations and/or translations that result from carrying out the optimization described.
- this processing means the use of (mathematical) optimization algorithms to determine the orientations and/or positions of the segment reference frames that optimize a previously defined objective function. These resulting angle curves (courses of standardized kinematics angles) and/or translation curves (courses of normalized kinematics translations) are then used for comparison and can be recorded for this purpose.
- the significance of the resulting comparison does not depend on the exact choice of the parameters to be optimized or the objective function(s).
- a device is proposed as a standardization system for standardizing an axis alignment of rotational kinematics data and/or an axis position of translational kinematics data, in particular an axis position/axis pose, with respect to a body joint of a patient, with: a number of sensors for detecting and/or recording Kinematics data sets and with a computer to which the sensors are connected or can be connected for data transmission purposes, the computer being adapted and designed to determine the orientation of the rotation data resulting from the recorded kinematics data sets and/or the position of the tibial and tibial shafts from the resulting translation data AE2046P-WO-0032 2022P00079 WO 8 / 35 to standardize femoral coordinate systems using a mathematical optimization method.
- a (normalization) method for standardizing an axis alignment and/or an axis position of kinematics data, in particular rotational kinematics data and/or translational kinematics data, with respect to a body joint of a patient by means of a device, preferably a standardization system according to the present disclosure proposes the following method steps: acquiring kinematic data sets relating to a patient's body joint using a number of sensors; transmission to a computer; Providing rotational data and/or translational data resulting from the kinematics data sets and standardizing the orientation and/or position of tibial and femoral coordinate systems for the provided rotational data using a mathematical optimization method.
- the present disclosure relates to a device and a method according to which the influence of the axis alignment on kinematics data (with regard to a patient's joint, in particular a knee joint) as well as effects can be determined/reduced and an approach for normalization or standardization is provided.
- the present disclosure relates to a standard kinematics evaluation system for recording, normalizing and evaluating biomechanical kinematics data of a (selected) joint of a patient with: at least one recording device that is adapted to detect biomechanical kinematics of the patient's joint by means of sensors to capture (in particular kinematics rotations and kinematics translations), record and make them available in a computer-readable manner; and a visual display device, in particular a surgical monitor, for visual output to a user.
- the standard kinematics evaluation system has a control unit that is specially adapted to: process the provided recorded kinematics of the patient and from this at least a course of, in particular three, kinematics angles (as rotation angle graphs) and / or of, in particular three , translations of AE2046P-WO-0032 2022P00079 WO 9/35 (considered) joint relative to a first joint element with a first joint coordinate system and relative to a second joint element with a second joint coordinate system to be determined via a normalization unit that is adapted for this purpose and is designed to determine a rotation vector or a rotation matrix for an adjustment of an orientation of the first joint coordinate system via a predetermined target optimization and/or a translation vector for an adjustment of a position of the first joint coordinate system via a predetermined target optimization, and one Rotation vector or a rotation matrix for an adjustment of an orientation of the second joint coordinate system and / or via a predetermined target optimization to determine a translation vector for an adjustment of a position
- a method for standardizing reference frame orientations and/or reference frame translations in biomechanical kinematic analysis using specific mathematical criteria is provided.
- Very small changes in the orientation or positions of the underlying (reference) coordinate systems can cause large differences in the (characteristics of) the kinematics data.
- this effect can be taken into account when working out differences between gait patterns in order to rule out that differences found are based on such alignment errors of the axes.
- Examples of normalization scenarios include post-processing of gait laboratory data (for standardization purposes) and pre-processing of known kinematic gait patterns for comparison (for harmonization purposes).
- a standard kinematics evaluation system for recording, normalizing and evaluating biomechanical kinematics data of a patient's joint and an associated method are provided, which a laxity and/or stability and/or function of a human body joint, in particular a knee, is evaluated (characterized) in a standardized (and thus standardized manner), this system or the method being based on a mathematical predetermined target optimization, which corresponds to a reference frame
- the present disclosure is optimized and therefore standardized with regard to a position and/or orientation (reference frame alignment method). This allows consistent and comparable measurements to be achieved.
- this system and method which can be used independently if necessary, has a recording of kinematics data over a period of time or at several points in time, which are stored accordingly and a comparison unit can be adapted to record changes over time. Particular attention is therefore paid to detecting kinematic changes over time.
- the standard kinematics evaluation system according to the second aspect can in particular have optical and/or inertial sensors which are attached or attachable to the (relevant) joint segments (i.e.
- joint segments adjacent to the joint to be examined are releasably fixed or fixable, for example by means of a Velcro, an adhesive or a tape, and are adapted to capture spatial or inertial data which are suitable for the movements of the joint segments during a series of activity cycles, be it passively through movement of a joint by a medical professional or actively, for example Walking or running.
- the recorded (raw) data from the sensors is forwarded to a control unit, which processes this data on the basis of a biomechanical model in order to calculate the corresponding kinematic signals of the joints (in particular the joint segments associated with the joint).
- a reference frame alignment method based on mathematical optimization of predetermined AE2046P-WO-0032 2022P00079 WO 11 / 35 statistical parameters based, in particular according to the present disclosure, can be used to characterize these kinematic signals and for (re)alignment/orientation and/or (re)positioning of the respective local Joint segment coordinate frame to fulfill a predetermined underlying objective function. This enables consistent and reliable standardization of kinematic measurements for valid data comparison, especially for analysis regarding a point in time of interest, be it current, historical or future.
- This reliable quantification of joint laxity and/or joint stability and/or function of the joint is particularly advantageous in order to determine a change, in particular deterioration, in a joint and thus an optimal or best time for a surgical intervention or to determine the course of a therapeutic treatment to evaluate, in particular the progress of physiotherapy and/or rehabilitation after surgery.
- the present invention provides a technical application for quantifying joint laxity in human, animal or mechanical joints, which is preferably adapted to detect a change, in particular a deterioration and/or progression, in a human and/or animal joint, such as a knee , a hip, a shoulder, a head, a neck, an elbow and the associated (tissue) soft parts, in particular ligaments, muscles, cartilage, to be recorded over time and to be evaluated on the basis of this recording.
- a control unit can be adapted to calculate a so-called optimization remainder and output this to a medical specialist.
- An evaluation of the optimization residual provides a direct objective measure of the agreement of the joint/axis estimate with a perfect joint/hinge.
- a phenotyping method for distinguishing between kinematic phenotypes of a AE2046P-WO-0032 2022P00079 WO 12 / 35 human joint on the basis of movement data in order to make the choice of treatment, for example the implant type, the implant position and / or the implant alignment (orientation) relative to the affected joint segments before the operation (e.g. at a total knee endoprosthesis).
- the center of rotation of the first joint segment, in particular of the thigh can be used as the new origin of the frame (in particular after normalization according to the present disclosure as a second step) relative to an original (anatomical) first joint segment, in particular of the thigh, define.
- This new position of the first joint segment (such as the femur) enables the characterization of the joint kinematics (particularly the knee joint) and individualized treatment recommendations, for example by determining the specific implant design and/or the position and/or orientation that best suits a particular Phenotype/patient fits, thereby optimizing patient satisfaction and implant lifespan/durability.
- This third aspect serves to facilitate consistent identification of subject phenotypes based on kinematic signals, in particular by facilitating the analysis of three or six complete time series (three translations or three rotations or both three translations and rotations) over a movement loading cycle to provide a simple Evaluation of a 3x1 vector that represents the relative first joint segment (especially the femoral) frame center after standardization of the kinematic data set with a so-called REFRAME.
- a virtual femoral center of rotation can be determined using an appropriate kinematics definition (translations of the femur expressed in a tibial frame as well as any rotation definition) and appropriate optimization criteria, in particular minimization of a root mean square error (RMS) of all three translation components.
- This virtual femoral rotation center is directly related to the characteristic movements of common implant types, such as in particular a medially stabilized (MS) implant type with a medial AE2046P-WO-0032 2022P00079 WO 13 / 35 rotation center, a laterally stabilized (LS) implantation type with a lateralized rotation center or a posteriorly stabilized (PS) implantation type with a more distal rotation center.
- MS medially stabilized
- LS laterally stabilized
- PS posteriorly stabilized
- the phenotyping method can in particular have as a further step, determining a virtual femoral center of rotation, and based on the femoral center of rotation, selecting an implantation type, in particular determining the implantation type from the set of LS implantation type, MS implantation type and PS implantation type.
- a new joint coordinate system can be determined according to the present disclosure and it can be determined to which coordinate system of MS, LS and PS this new joint coordinate system is closest.
- This next KOS indicates the implant type. For example, if the joint coordinate system is closest to the LS-KOS, it may be determined that an LS implant type is appropriate.
- a method and a system are provided that evaluate knee kinematics before the operation in order to determine the type of implant that optimally matches the needs, a gait and a movement profile of a specific patient in order to improve the treatment result and the lifespan of the to improve medical devices.
- the disclosure according to the third aspect can in particular be part of a medical device for measuring joint kinematics in the clinical environment during the preparation of a total knee arthroplasty operation, in particular part of a standard kinematics evaluation system according to the present disclosure.
- a (same) method can be used to determine an actual hip pivot point based on gait data with an anatomical reference in the pelvis.
- the alignment of the axes is also specified so that a uniform interpretation of the joint movement is possible without crosstalk between the axes.
- This enables the (correct) comparison of new movement data with historical movement data.
- the joint centers can be determined in one step for the evaluation of a knee adduction moment.
- this approach applies not only to joints and medical applications, but also to themselves AE2046P-WO-0032 2022P00079 WO 14/35 relates to other areas of application in which movement patterns from different sources or moving objects are (should be) clustered.
- this method can also make it much easier to compare movement patterns, as less effort has to be put into the correct arrangement of the coordinate frames.
- the at least one detection device can have at least one acceleration sensor and/or a gyrosensor, in particular an inertial measurement unit (IMU), as a sensor, and the detection device can be adapted for this, for example attached to an extremity of the patient, in the area of the patient's joint to be, in particular on the first joint element and / or the second joint element.
- IMU inertial measurement unit
- the at least one detection device can have at least one optical recording unit as a sensor, in particular a 3D recording unit, preferably a stereo camera, which records biomechanical kinematics of the patient's joint, preferably via optical markers, in particular via passive infrared markers, which are attached to the patient in the area of the joint, preferably at least to the first joint element and / or the second joint element.
- the predetermined target optimization can be a minimization of a variance, a standard deviation, a squared error and/or a statistical error of the regression of one or more kinematics parameters, in particular one or more kinematics angles and/or one or more kinematics translations , be determined.
- three kinematics angles preferably two kinematics angles, can be determined, in which, AE2046P-WO-0032 2022P00079 WO 15/35 in particular over exactly one cycle of a joint movement, in particular a step cycle, a minimization of a variance or a squared error is determined as a target function and a change in an orientation of the first joint coordinate system and the second joint coordinate system is defined as a goal or result to be determined.
- the control unit therefore calculates a rotation/re-orientation of the first local joint coordinate system about its origin and a rotation/re-orientation of the second local joint coordinate system about its origin, at which one, two or three of three kinematics angles are considered and in these cases, for example, an area of the graph of the corresponding kinematics angle is minimized around its zero line.
- the selected parameter can in particular be a variance, a standard deviation, a squared error or a statistical error of the regression of one or more kinematic angles.
- - Model that uses the variance, the standard deviation, the root mean square error, the root mean square error or the statistical error of the regression of one or more kinematic angles as criteria for minimizing crosstalk.
- the standard kinematics evaluation system can be adapted to detect a knee joint with a tibial coordinate system as the first joint coordinate system (tibial KOS) and a femur coordinate system (femoral KOS) as the second joint coordinate system and (by means of a gait analysis) a course to determine the three kinematics angles of a flexion, an adduction and an internal rotation, and/or a course of the three kinematics translations, in particular with exactly a single step cycle, and the control unit can be adapted in particular to determine a gait type and as an assessment /or output a selection of a size of a knee endoprosthesis (/knee implant) and/or an orientation of a knee endoprosthesis as an evaluation parameter.
- minimization of a root mean square error can be defined as the predetermined target optimization (from the graph) of the kinematics angle of adduction and/or (the graph) of the kinematics angle of internal rotation.
- Minimizing a root mean square error is a special one AE2046P-WO-0032 2022P00079 WO 16 / 35 suitable target optimization, since in this way individual deflections are given less weight and any errors can be minimized.
- an RMSE Root Mean Square Error
- these can be reduced from 0.79 ⁇ 0.30° to 0.29 ⁇ 0.30° by rotating the coordinate systems by 3.32 ⁇ 1.24° around the associated screw axis.
- minimization of a variance (from the graph) of the kinematics angle of adduction and/or (the graph) of the kinematics angle of internal rotation can be defined as the predetermined target optimization.
- the graph of the corresponding kinematics angle can have an offset compared to the zero line, but the graph should be as smooth as possible, i.e. flat compared to the "new, offset zero line", so to speak.
- control unit can have a memory unit, a database with an assignment of standardized kinematics angles and/or standardized kinematics translations to evaluation parameters, in particular an assignment of the standardized kinematics angles to a size and orientation of a knee endoprosthesis.
- a memory unit a database with an assignment of standardized kinematics angles and/or standardized kinematics translations to evaluation parameters, in particular an assignment of the standardized kinematics angles to a size and orientation of a knee endoprosthesis.
- control unit can be trained as an artificial intelligence system using a training data set with standardized kinematics angles and/or kinematics translations as input and an output to an endoprosthesis of the patient's joint, so that the control unit is adapted to detect a new biomechanical kinematics of a patient via standardized kinematics angles and/or standardized kinematics translations using an artificial intelligence method to output an evaluation of an endoprosthesis, in particular a size and an orientation.
- control unit can be adapted to determine the kinematics angles based on the recorded biomechanical kinematics of the patient, in particular when using an inertial measuring unit (IMU) as a sensor to calculate three kinematics angles based on the accelerations and angular velocities.
- IMU inertial measuring unit
- An IMU generally has an acceleration sensor for detecting acceleration in three directions and also a gyroscope for determining angular velocities.
- kinematics data sets for level walking on an (established) knee joint simulator VIVO, AMTI, Watertown, MA
- VIVO anterior-to-ematics evaluation system
- sensors preferably acceleration sensors and/or optical sensors, in particular at least one initial one Measuring unit, can be recorded.
- the sensors of the detection device can preferably be arranged in/on a knee cuff and can therefore be temporarily attached and positioned on the knee in the manner of a bandage, for example.
- the sensors are also preferably connected to the control unit (e.g.
- a standard kinematics evaluation method for recording, normalizing and evaluating biomechanical kinematics data of a (selected) joint of a patient in particular in a standard kinematics evaluation system according to the present disclosure solved by having the steps: detecting a biomechanical kinematics of a patient using sensors of a detection device; Determining, by a control unit based on the patient's provided kinematics, a course of kinematics angles and/or kinematics translations of the joint relative to a first joint element with a first joint coordinate system and a second joint element with a second joint coordinate system.
- the standard kinematics evaluation method or the control unit of the standard kinematics evaluation system can be adapted to use a crosstalk minimization method as the target optimization.
- the standard kinematics evaluation method or the control unit of the standard kinematics evaluation system can be adapted for this purpose AE2046P-WO-0032 2022P00079 WO 19 / 35 To carry out optimization of a reference frame orientation (reference coordinate system) in knee kinematics.
- the standard kinematics evaluation method or the control unit of the standard kinematics evaluation system can be adapted to provide normalization (or standardization) of movement measurement systems.
- this includes systems based on optical markers and systems based on inertial measurement units (IMU).
- the standard kinematics evaluation method can detect, normalize and evaluate a patient's knee joint as a joint, with the predetermined target optimization being a minimization of a root mean square error (RMSE) (from the graph) of the kinematics angle of adduction and / or (the graph) of the kinematics angle of the internal rotation.
- RMSE root mean square error
- a patient's knee joint can be recorded, standardized and evaluated as a joint, with a minimization of a variance of the kinematics angle of adduction and/or the kinematics angle of internal rotation being defined as a predetermined target optimization .
- a computer-readable storage medium the tasks are fulfilled in that it comprises instructions which, when executed by a computer, cause the computer to carry out the method steps of the standard evaluation method according to one of the present claims.
- FIG. 1 is a perspective view of a knee joint with a femoral coordinate system to illustrate an error in the prior art AE2046P-WO-0032 2022P00079 WO 20/35 regarding an analysis and evaluation that can occur in the event of a deviation in orientation
- 2 is a schematic view of a standard kinematics evaluation system according to a first preferred embodiment of the present disclosure
- 3 and 4 show a schematic view to explain the three kinematics angles of the patient's knee joint with corresponding normalization
- FIG. 5 shows a sequence of a standard kinematics evaluation method according to a first preferred embodiment of the present disclosure
- 6 shows a comparison of different sources as input to the standard kinematics evaluation system or a standard kinematics evaluation method
- FIG. 6a to 6c A schematic representation to illustrate a normalization of kinematics data of a patient with comparison to a kinematics simulation in which both the amplitude and the characteristics of the curves a to d change fundamentally due to the reorientation of the joint coordinate system as a reference system.
- 7 shows an overview of various acquisitions of kinematics data from patients that were normalized according to the standard kinematics evaluation system or the standard kinematics evaluation method of the present disclosure via reorientations of the joint coordinate system.
- FIG. 8 shows a flowchart of a standard kinematics evaluation method according to a preferred embodiment
- Fig. 9 is a schematic representation of exemplary frame positions in a knee joint with typical centers of rotation for common implant types.
- the femoral coordinate system KOS
- the maximum width of the corridors in adduction and internal rotation for ⁇ 3° of the rotations Ry and Rz in the orientation of the tibial and femoral coordinate system is already 14.5°.
- crosstalk with corresponding crosstalk effects results from an incorrect alignment of the axes of the joint coordinate system, so that, for example, a rotation/rotation in one plane is partially perceived as a rotation in other planes.
- a rotation of the femoral coordinate system about an axis therefore not only causes a change in a single kinematics angle, but also has an influence on the other two kinematics angles.
- the standard kinematics evaluation system 1 is used to record, standardize and (comparatively, possible due to the standardization) evaluation of biomechanical kinematics data of a knee joint G of a patient (P), as explained below.
- the standard kinematics evaluation system 1 has at least one recording device 2, which records this via an optical sensor system 4 and provides it to a control unit 8 in a computer-readable manner.
- Evaluation system 1 for a display of data on a surgical procedure to be carried out on the patient P and an output of the evaluation results on a display device, for example in the form of a surgical monitor.
- control unit 8 is specially adapted to process the detected kinematics of the patient P provided by the detection device 2 and, based on the kinematics data, to create a course of three kinematics angles 14, 16, 18, as a rotation angle graph, (and / or three kinematic translations) of the knee joint G relative to a first joint element G1 with a first joint coordinate system 20 and relative to a second joint element G2 with a second joint coordinate system 22.
- the three kinematics angles 14, 16, 18 (and/or three kinematics translations) of a model joint are extracted from the wealth of kinematics data.
- the standard kinematics evaluation system 1 is adapted to detect a knee joint G with a tibial coordinate system (tibial KOS) as the first joint coordinate system 20 and a femur coordinate system (femoral KOS) as the second joint coordinate system 22 and a course of the three kinematics angles 14, 16, 18, namely a flexion 14, an adduction 16 and an internal rotation 18, to be determined in exactly a single step cycle.
- tibial KOS tibial coordinate system
- femur coordinate system femur coordinate system
- the standard kinematics evaluation system 1 is adapted to detect a knee joint G with a tibial coordinate system (tibial KOS) as the first joint coordinate system 20 and a femur coordinate system (femoral KOS) as the second joint coordinate system 22 and a course of the three kinematics angles 14, 16, 18, namely a flexion 14, an adduction 16 and an internal rotation 18, to be determined in exactly a single step cycle.
- a rotation vector 24 for adapting an orientation of the first joint coordinate system 20 is determined via a standardization unit 10, which is adapted and designed to use a predetermined target optimization, and a rotation vector 26 to determine an orientation of the second joint coordinate system, a normalization is carried out.
- the standard kinematics evaluation system 1 has an evaluation unit 12, which is adapted to carry out an evaluation with regard to the joint G for at least one predefined evaluation parameter based on the standardized kinematics angles 14 ', 16', 18' as movement data.
- a selection of a size of a knee endoprosthesis and an orientation of a knee endoprosthesis for the surgical procedure are output as evaluation parameters.
- the visual output of the evaluation is carried out by the display device 6, in particular by displaying preoperative CT data of the patient P, in which the simulated knee endoprosthesis with the appropriate size and orientation is displayed.
- the present standard kinematics evaluation system 1 allows robust and reliable evaluations to be carried out because errors are minimized.
- the at least one detection device 2 has several inertial measuring units 28 (hereinafter referred to as IMU) as sensors, which are attached to two (releasable) knee cuffs 36 on the patient P on the upper and lower legs.
- IMU inertial measuring units
- the standard kinematics evaluation system 1 has a further detection device 2, which has an optical recording unit 30 in the form of a stereo camera 32, which is aligned obliquely from above towards a floor area in order to externally determine the biomechanical kinematics of the joint G of the patient P capture.
- a visualization of the three kinematics angles 14, 16, 18 and the joint coordinate systems 20, 22 of the standard kinematics evaluation system 1 are shown schematically for explanation purposes.
- the aim of the optimization in this embodiment is to minimize a root mean square error (RMSE) when varying an orientation of the joint coordinate systems 20, 22.
- RMSE root mean square error
- first rotation vector 24 and second rotation vector 26 should be found in which a root mean square error (RMSE) of both the adduction kinematics angle 16 is minimized and a root mean square error (RMSE ) is minimized by the internal rotation angle 18.
- RMSE root mean square error
- the first femoral rotation vector is 24 (Rx, Ry, Rz) (-0.055, 2.106, 2.44) and the second tibial rotation vector is 26 (Rx, Ry, Rz) (0.051, 2.157, -0.295).
- the rotations take place gimbal-wise, i.e. first the rotation around the X-axis, then the rotation around the Y-axis and finally the rotation around the Z-axis (with the origin remaining the same).
- FIG. 5 shows a process for determining an orientation/alignment of the tibial and femoral coordinate systems (reference frame) by minimizing the RMSE of adduction and internal rotation for normalization.
- zero adduction/internal rotation can be assumed throughout the entire cycle.
- kinematics data of the patient is recorded and thus also kinematics data for a joint of interest in the patient.
- three kinematics angles 14, 16, 18 for a step cycle are extracted from the wealth of kinematics data, these kinematics angles 14, 16, 18 still being error-prone and a slight deviation in the alignment of the tibial or femoral coordinate system 20, 22 has major influences on the course of the kinematics angles.
- the target optimization step takes place with regard to minimizing a root mean square error (RMSE) of the adduction angle and the internal rotation angle, i.e. two of the three kinematics angles, the calculation of the rotation vectors, the application to the coordinate systems, whereby the newly oriented coordinate system now forms the reference systems for the femur and the tibia, and thereby the normalization of the kinematics angles 14', 16' and 18' respectively AE2046P-WO-0032 2022P00079 WO 25 / 35 Courses that have changed accordingly due to the reorientation of the coordinate systems 20, 22.
- RMSE root mean square error
- 6 shows a standardization of the orientations of the reference system when measuring knee kinematics with a comparison data set of kinematics from another patient, in particular from six patients.
- the standard kinematics evaluation system 1 normalizes reference frame orientations from measurements with different data sources in order to then make them comparable.
- 6a to 6c show a schematic view of several recordings of kinematic angles of flexion 14, adduction 16 and internal rotation 18 by two different detection devices, optical and IMU.
- Fig. 7 shows a schematic view of various series of recorded kinematics, without and with corresponding normalization by the standard kinematics evaluation system 1.
- Fig. 8 shows a flowchart of a standard kinematics evaluation method according to a preferred embodiment of the present disclosure.
- the standard kinematics evaluation method for recording, standardization and evaluation AE2046P-WO-0032 2022P00079 WO 26/35 of biomechanical kinematics data of a knee joint G of a patient P has the following steps.
- a biomechanical kinematics of a patient P is detected using sensors 4 of a detection device 2.
- sensors 4 of a detection device 2 In particular, this can be done via a stereo camera and optical markers or sensors attached to the patient.
- a control unit 8 determines, based on the provided kinematics of the patient P, a course of three kinematics angles 14, 16, 18 of the knee joint G relative to a first joint element G1 (femur) with a first joint coordinate system 20 and a second joint element G2 (tibia) with a second joint coordinate system 22.
- step S3 determining, by a normalization unit 10 of the control unit 8, via a predetermined target optimization, a rotation vector 24 for a Adjusting an orientation of the first joint coordinate system 20 and a rotation vector 26 for adjusting an orientation of the second joint coordinate system 22;
- step S4 of normalizing the course of the kinematics angles 14, '16', 18' takes place by adapting the first and second joint coordinate systems 20, 22 by the correspondingly determined rotation vectors 24, 26 So the coordinate systems are rotated according to the rotation vectors and their orientation is adjusted accordingly (and/or the translation vectors are shifted and their positions are adjusted accordingly).
- a final step S5 an evaluation of the knee joint is carried out with regard to a predefined evaluation parameter based on the AE2046P-WO-0032 2022P00079 WO 27 / 35 standardized kinematics angle.
- a classification of a gait is determined as an evaluation parameter and output by a display device 4 in a final step S6.
- Fig. 9 shows examples of different frame positions and thus also coordinate systems in a knee joint.
- a standard kinematics evaluation method for recording, normalizing and evaluating biomechanical kinematics data of a joint G of a patient P can be carried out in a standard kinematics evaluation system 1 according to the present disclosure in order to determine a translation vector and thereby a virtual position of the new joint coordinate system to be defined as a framework.
- the phenotyping method according to the third aspect of the present disclosure can then be carried out in a further step. For example, if the new joint coordinate system is determined for the joint, which is closest to the MS coordinate system (KOS), it can be determined that an MS implant type is suitable.
- KOS MS coordinate system
- a new joint coordinate system is determined that is closest to the LS-KOS, it can be determined that an LS implant type is suitable.
- a new joint coordinate system is determined that is closest to the PS-KOS, it can be determined that a PS implant type is suitable.
- AE2046P-WO-0032 2022P00079 WO 28 / 35 List of reference symbols 1 standard kinematics evaluation system 2 detection device 4 sensors 6 display device 8 control unit 10 normalization unit 12 evaluation unit 14 flexion kinematics angle 14 'normalized flexion kinematics angle 16 adduction kinematics angle 1 6' more standardized Adduction kinematics angle 18 Internerotation kinematics angle 18' standardized internerotation kinematics angle 20 first joint coordinate system 22 second joint coordinate system 24 first rotation vector 26 second rotation vector 28 Inertial measurement unit (IMU) 30 optical recording unit 32 stereo camera 34 storage unit 36 knee cuff G joint G1 first joint element G2 second joint element P patient S1 step of detecting biomechanical kinematics by means of a detection device S2 step of determining a course of kinematics angles S3 step of determining adjustment orientation AE2046P-WO-0032 2022P00079 WO 29 / 35 S4 step normalize course of the
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102022112117 | 2022-05-13 | ||
| DE102022125697.9A DE102022125697A1 (de) | 2022-05-13 | 2022-10-05 | Vorrichtung und Verfahren zur Standardisierung der Achsausrichtung und -position von Kinematikdaten bezüglich eines Körpergelenks eines Patienten |
| PCT/EP2023/062780 WO2023218039A1 (de) | 2022-05-13 | 2023-05-12 | Vorrichtung und verfahren zur standardisierung der achsausrichtung und -position von kinematikdaten bezüglich eines körpergelenks eines patienten |
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| EP23723974.4A Pending EP4522024A1 (de) | 2022-05-13 | 2023-05-12 | Vorrichtung und verfahren zur standardisierung der achsausrichtung und -position von kinematikdaten bezüglich eines körpergelenks eines patienten |
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| US (1) | US20250311943A1 (de) |
| EP (1) | EP4522024A1 (de) |
| JP (1) | JP2025515863A (de) |
| AU (1) | AU2023269250A1 (de) |
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| US20250072790A1 (en) * | 2023-08-30 | 2025-03-06 | Globus Medical, Inc. | Ligament balancing tool and method for same |
| CN119993544B (zh) * | 2025-04-14 | 2025-06-20 | 青岛大学 | 基于医疗信息处理的风湿活动度评估系统 |
| CN120126680B (zh) * | 2025-05-12 | 2025-08-01 | 杭州摩西科技发展有限公司 | 元宇宙智慧运动中的个性化训练计划生成方法及系统 |
| CN121503169B (zh) * | 2026-01-12 | 2026-04-24 | 天津工业大学 | 一种评估运动服张力带结构性能的方法及系统 |
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| EP3094249B1 (de) * | 2014-01-13 | 2021-09-15 | Eiffel Medtech Inc. | Verfahren und system zur visuellen darstellung der kinematik eines patientengelenks und zugehöriger parameter |
| US9532845B1 (en) * | 2015-08-11 | 2017-01-03 | ITKR Software LLC | Methods for facilitating individualized kinematically aligned total knee replacements and devices thereof |
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- 2023-05-12 WO PCT/EP2023/062780 patent/WO2023218039A1/de not_active Ceased
- 2023-05-12 EP EP23723974.4A patent/EP4522024A1/de active Pending
- 2023-05-12 US US18/865,210 patent/US20250311943A1/en active Pending
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| AU2023269250A1 (en) | 2025-01-02 |
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