Patent Grant
11865061
This application is a U.S. National Entry and claims priority to PCT International Patent Application No. PCT/EP2018/085781, filed 19 Dec. 2018, and entitled “ORTHOPAEDIC TECHNICAL DEVICE AND METHOD FOR CONTROLLING SAME”, which claims priority to Germany Patent Application No. 10 2017 131 319.2 filed 27 Dec. 2017, the entire disclosures of which are incorporated herein by this reference.
The invention relates to an orthopedic device, in particular an orthosis or exoskeleton, with an upper part and a lower part, which are connected to each other by a joint device so as to be pivotable about a joint axis and have fastening devices with which the orthopedic device, e.g. exoskeleton or orthosis, can be secured to a limb, and with an actuator, which is secured to the upper part and the lower part at fastening points and influences a pivoting of the upper part relative to the lower part. The invention further relates to a method for controlling an orthopedic device, in particular an orthosis or exoskeleton, with an upper part and a lower part, which are connected to each other by a joint device so as to be pivotable about a joint axis and have fastening devices with which the orthopedic device, e.g. exoskeleton or orthosis, can be secured to a limb, and with an actuator, which is secured to the upper part and the lower part at fastening points and influences a pivoting of the upper part relative to the lower part, and with at least one sensor coupled to a controller which activates or deactivates an adjustment device for adjusting an extension stop that limits a maximum joint angle.
Orthoses or exoskeletons, together referred to below as orthoses, are used inter alia to support or maintain the function of a still present extremity or limb. For this purpose, the orthosis is secured to the limb. In the case of an orthosis of the lower extremity, for example an orthosis engaging over the knee joint, upper parts and lower parts or rails are placed on the thigh and on the lower leg and are connected to one another via a joint device, the orthotic knee joint. In the case of an ankle orthosis, the foot is fixed on a foot part which is connected via an orthotic ankle joint to a lower-leg part, which in turn serves as upper part. The same applies to a hip joint orthosis or to an orthosis that bridges more than two natural joints. There are also orthoses for upper extremities, for example an orthosis that bridges the elbow joint. The upper part is in each case regarded as the proximal component of an orthosis and is connected to a distal component as lower part via the joint device. Fastening devices take the form of shells, straps, clasps or other devices that prevent the limb from coming loose from the orthosis.
Prostheses serve to replace a lost limb and are often equipped with a prosthetic joint which pivotably connects two prosthesis components to each other. In order to influence the movement of the components relative to each other, use is made of actuators, e.g. dampers, brakes and/or drives, which, either controlled or uncontrolled, influence pivoting movements, in particular damp or support such movements.
In order to influence the movements of the upper part and lower part relative to each other during the pivoting movement, for example in order to assist or impede the pivoting movement, use is made of actuators which are secured to the upper part and the lower part. Movement assistance can be effected by supply of energy from an energy store in an embodiment of the actuator as a drive. The energy store can take the form of spring devices or electrical energy stores for driving a motor or a pump. Purely passive actuators are dampers or brakes which provide an adjustable resistance against the pivoting movement. The damping can be used both in terms of the flexion direction and also the extension direction. Stop elements are present in the respective joint device or in the actuator, such that, when a maximum position of the upper part relative to the lower part is reached, a further movement is avoided and a stop is ensured. The stop elements can be provided both for a flexion direction, in which a joint angle is reduced, and also for the extension direction, in which the joint angle is increased. The maximum extension angle is generally reached when there is an angle of 180° between the longitudinal orientation of the upper part and the lower part. The joint angle correlating to this derives from the position of maximum extension dictated by the anatomical and physiological circumstances of the patient's body. These can also represent an in most cases pathological hyperextension position, as a result of which the joint angle can be over 180°. Hyperextension can occur, for example, in the case of a knee joint in which the angle between the rear aspect of the calf and the rear aspect of the thigh can be greater than 180°. Correspondingly, hyperextension occurs in the case of an elbow joint when there is an angle of less than 180° between the forearm and the triceps side of the upper arm.
WO 2009/097841 A1 discloses an orthopedic knee joint, comprising an upper part, on which upper attachment means are arranged, and a lower part pivotably mounted on the upper part, with attachment means for orthopedic components, and a stop for limiting an extension movement. The stop is configured displaceably and is coupled to an adjustment device, which is coupled in turn to a controller which, in accordance with sensor data, actuates the adjustment device and changes the position of the stop. The orthopedic knee joint can also be designed as an orthotic knee joint. The application concerns adapting the position of the extension stop to different instantaneous or short-term demands during walking and standing. Adaptation to the anatomical conditions presented by the user is not disclosed.
The position of the extension stop of an orthosis has to be adapted to the anatomical and physiological circumstances of the particular user. In addition to static extension stops, which are set once during the adaptation of the orthosis to the patient and are not altered until renewed adjustment by an orthopedic technician, the quality of the setting of the extension stop depends on the level of experience of the orthopedic technician. The setting is made easier in the case of extension stop positions that are adjustable by motor, where the individual positions themselves have to be stored in the control system or be input by the orthopedic technician. Correction of extension stop positions may be necessary, for example, in order to be able to correct manufacturing inaccuracies or to take account of flexion contractures in pathological states. These contractures may change over the course of time, for example as a reaction to therapy. Changes may also occur over the course of a day, caused by the activities of the patient. Therefore, a correction of the extension stop position or of the orientation of the limb on the upper part relative to the lower part may be necessary in order to make changes during daily wear or in order to react to different movement situations.
The object of the present invention is to make available an orthopedic device and a method for controlling an orthopedic device, which in a simple way improve the wearing comfort for the user of the orthosis and permit adaptation to changing anatomical and physiological circumstances.
According to the invention, this object is achieved by an orthopedic device having the features disclosed herein and by a method having the features of also disclosed herein. Advantageous embodiments and developments of the invention are disclosed in the description and the figures.
In the orthopedic device according to the invention with an upper part and a lower part, which are connected to each other by a joint device so as to be pivotable about a joint axis and have fastening devices with which the orthopedic device can be secured to a limb, and with an actuator, which is secured to the upper part and the lower part at fastening points and influences a pivoting of the upper part relative to the lower part, provision is made that the orientation of the lower part is adjustable relative to the limb that can be secured to the upper part. In addition to a change of the orientation of the upper part relative to the lower part about the pivot axis of the joint device by a change of the end stops of the joint device and therefore the change of the end positions of the upper part and of the lower part relative to each other, it is possible to change the orientation of the limb on or in the upper part or lower part relative to the upper part or lower part. In this way, in an embodiment of the orthopedic device as an orthosis, the maximum attainable extension angle and/or flexion angle of the limb can be repeatedly changed without manipulating the joint device or the actuator. In an embodiment of the orthopedic device as a prosthesis, the orientation of the stump in or on the upper part can be changed or the stump can be used in different orientations in the upper part, e.g. in a prosthesis socket, as a result of which the orientation of the lower part to the stump can be changed and can be fixed in the respective position. Maneuvers carried out on the prosthetic joint are not necessary for this purpose. Alternatively or in addition, the orientation can be changed by changes on or in the actuator, since the maximum attainable angle in the flexion direction and/or extension direction is limited and changed by a change of the maximum range of movement of the actuator in one or other direction. Alternatively or in addition, the orientation of the lower part relative to the upper part can be achieved by adjustable stops or limits on the upper part and/or lower part or the joint device, for example by mechanical stops, hydraulic stops or other setting or adjusting mechanisms.
An adjustable extension stop can be arranged and/or formed on the orthopedic device, and/or an exchangeable or adjustable support for the limb can be arranged thereon. The support can be configured as a padding, insert, cushion or inlay, which is variable in terms of its position and/or its volume, such that a changed orientation of the upper part and/or lower part relative to the limb can be achieved. The support can be arranged on a rail, a shell or a socket and can be displaced relative thereto by adjustment devices. Cushions or pads can be filled or emptied in order to change orientations. Alternatively or in addition, an adjustable flexion stop can be arranged or formed on the orthopedic device in order to achieve a mechanical or electronically controlled limitation of the pivoting of the joint device. In a variant of the invention, the extension stop is formed on or in the actuator, on or in a force-transmitting interface between the actuator and the upper part and/or lower part, and/or on or in the at least one joint device.
In a development of the invention, provision is made that the distance of at least one fastening point from the joint axis is adjustable. Mechanical end stops on the joint device can be provided which, for example, can be changed via screws or different inserts, such that different joint angles between the upper part and the lower part can be set as maximum joint angle. In addition or alternatively, an adjustment of the extension stop is provided within the actuator by electronically controlled opening and closing of hydraulic lines, or else a change in the actuator itself, for example by a change of the length of the housing or else by a lengthening or shortening of a piston rod via a thread adjustment. An electronically controlled adjustment of the extension stop, which is provided as a variant of the invention, requires a powerful control system, which is used in suitably configured orthoses or prostheses. Intervention in the set-up and in the dimensions of an actuator often proves difficult, since no standard actuators, for example standard hydraulic dampers or hydraulic drives, can then be used. Consequently, the change of the distance of at least one of the fastening points of the actuator on the upper part or the lower part relative to the joint axis is a simple way of adapting the orthopedic device and the extension stop attainable with an unchanged actuator. The extension stop is made available within the actuator by limiting for example the displacement path of a hydraulic piston within a cylinder. Alternatively or in addition, the extension stop can be made available within the actuator by limiting or changing the displacement path of a hydraulic piston within the cylinder. The extension stop can likewise be set or adjusted by suitably closing valves and/or blocking hydraulic lines, if the actuator is designed as a hydraulic actuator.
If the fastening point for example on the upper part is shifted farther proximally from the joint axis, a corresponding stop is reached at a smaller joint angle, i.e. before the position of maximum extension is reached. If the fastening point is shifted farther in the direction of the joint axis, the possible joint angle increases, and the extension stop is adjusted in the direction of an increasing extension or a maximum joint angle. The adjustment of the fastening point can take place in various ways, in particular by at least one of the fastening points being mounted displaceably on the respectively associated upper part or lower part or on a force-transmitting interface. In addition to an adjustability provided at just one point, it is also possible for both fastening points to be displaceable, wherein the proximal fastening point is displaceable on the upper part or on a proximal force-transmitting interface or is adjustable relative to the joint axis, and likewise the distal fastening point is formed adjustably on the lower part or a distal force-transmitting interface of the joint device or of a joint module.
In a development of the invention, provision is made that the fastening point is mounted, adjustable by motor, on the upper part or lower part or on a force-transmitting interface, so as to be able to displace the fastening point or the fastening points, preferably steplessly, and thus adjust the extension stop.
The fastening point can be mounted displaceably or movably, e.g. rotatably, on the upper part or lower part or on a force-transmitting interface of the joint device. The displaceability can in particular be rectilinear, for example in a straight guide rail or groove. The guide rail or the guide groove can also have a curved shape or some other shape, such that it can be formed as a slotted guide with a predefined movement path of the fastening point. Moreover, the fastening point can be mounted rotatably on the upper part or lower part, in which case an eccentric bearing changes the distance of the fastening point from the joint axis. The rotatability can be effected in stages or also steplessly. Similarly, in addition to a motor-driven rotation or an adjustment via a motor, the rotation, displacement or adjustment can be carried out by an orthopedic technician.
In a development of the invention, provision is made that the fastening point is arranged or formed on an adapter on which several fastening devices for the actuator and/or the joint device or a joint module are arranged. The adapter can be secured as a separate component on the upper part and/or the lower part or can be part of the upper part and/or lower part, such that, by suitable selection of the fastening device to which the actuator and/or the joint device is secured, the maximum attainable flexion angle and/or extension angle can be determined and adjusted. By the formation or arrangement of several fastening devices on one adapter, it is possible to secure the actuator and/or the joint device at different positions on the adapter. Each position of the fastening device offers another distance and leads to another extension stop upon full utilization of the extension path for the respective actuator. The fastening point can be arranged or formed on an exchangeable adapter, on which one or more fastening devices for the actuator and/or the joint device are arranged or formed. Instead of several fastening devices for the actuator and/or the joint device, it is also possible for just one fastening device to be formed on the adapter for the actuator and/or the joint device, such that for each extension stop a separate adapter has to be arranged on the upper part and/or lower part. This may be advantageous for the compensation of manufacturing tolerances or for adaptations to long-term changes in the anatomical circumstances presented by the patient. Various adapter plates with different fastening devices, for example patterns of holes or threaded inserts for the actuator, can be secured or arranged on the upper part and/or lower part. The joint device can be designed in particular as a joint module, which can be secured detachably to the upper part and the lower part. The modular set-up facilitates assembly and the adaptability to the particular user.
Alternatively, the fastening point or fastening points can be arranged or formed on an exchangeable component, in order to realize different positions of the fastening point or fastening points for the joint device. Devices for fastening the joint device or possibly also the actuator can be arranged at different locations or positions on the exchangeable components, such that, depending on the component used, a different extension stop is set. Each position of the fastening device offers another distance and leads to another extension stop upon full utilization of the extension path of the respective actuator. The fastening point can also be arranged or formed on an exchangeable component on which one or more fastening devices for the joint device or the actuator are formed.
In a development of the invention, provision is made that the upper part and/or the lower part and/or at least one force-transmitting interface of a joint device are variable in length. The upper part and/or the lower part and/or the force-transmitting interface can have a multi-part design, wherein the joint device is formed in a first part of the upper part and/or lower part or the interface, and the fastening point is arranged or formed on a second part. The first part and the second part of the upper part and/or of the lower part or the interface are connected to each other so as to be displaceable, for example via a frame or a rail which is variable in length, such that the fastening point can be shifted away from the joint device or the joint axis in order to adjust the extension stop. In principle, it is also possible that the first part and the second part are of a telescopic design and can be pushed one into the other and locked in the respective position. It is likewise possible that the first part or upper part and the second part or lower part are arranged pivotably on each other, in order in this way to obtain different distances of fastening points relative to the joint axis.
In a development of the invention, provision is made that the actuator has a housing of variable length and/or a piston rod of variable length, in order to set the maximum displacement path of the actuator. The housing can be designed to be variable in length via a thread or a telescopic embodiment of the housing parts. Alternatively or in addition, can via a piston rod of variable length, for example via a screw sleeve, which is designed to be adjustable and lockable by motor or by hand.
In a development of the invention, provision is made that at least one sensor for detecting the force transmitted between the upper part and the lower part or for detecting the transmitted moment is assigned to the upper part, the lower part or the joint device. Similarly, a sensor can be provided for detecting a joint angle, the spatial position of the upper part and/or of the lower part, or, alternatively or in addition, a sensor for detecting biometric signals of a user can be assigned to the orthopedic device, e.g. orthosis. As biometric signals it is possible, for example, to use myoelectric signals of the musculature of the limbs, e.g. of the limb to which an orthosis is secured or which performs compensation movements, so as to detect muscle activities of the patient and to deduce therefrom whether and to what extent a patient or user is able to perform certain movements, which muscles are contracted, and to what extent they are contracted to perform the movement, and to what extent muscle contractions and control devices for an actuator or the extension stop correspond to medical requirements. The biometric signals can also be captured on untreated limbs, in order to be able to draw conclusions for example in the context of the evaluation of compensation movements. On the basis of the sensor signals, or at least taking account of the sensor signals, it is then possible to set the extension stop positions corresponding to the anatomical conditions or requirements.
The orthopedic device is preferably designed as a controllable device and is provided with or coupled to at least one sensor, which is coupled to a controller which activates or deactivates an adjustment device for adjusting an extension stop that limits a maximum joint angle. The extension stop, in accordance with sensor data, is moved from a starting position, in which the upper part is located in a position of flexion relative to the lower part, to an end position, in which the upper part is located, relative to the lower part, in a position different than the starting position. The controller can be designed to detect the sensor data over a period of time and to compare them to a threshold value, wherein an adjustment of the extension stop takes place only when the threshold value is reached over a defined period of time.
In one development, provision is made that the maximum joint angle is adjustable, and, in accordance with the measured joint angle, the extension stop is adjustable as far as the maximum joint angle. The controller can be configured such that, when the extension stop is reached, the moment effective about the joint axis and/or the force effective between the upper part and the lower part is measured, and, if a threshold value is exceeded, the extension stop is moved in the direction of its end position. If the threshold value is not reached, the extension stop is moved in the opposite direction.
The controller can be further configured to detect resistance values of the actuator during the pivoting movement and to correlate them with sensor values concerning the joint angle and the forces and/or moments prevailing between the upper part and the lower part, and, if a force and moment profile deviates from the resistance profile, to perform an automatic adjustment of the extension stop. Preferably, the extension stop is adjustable auto-adaptively.
In the method according to the invention for controlling an orthopedic device with an upper part and a lower part, which are connected to each other by a joint device so as to be pivotable about a joint axis and have fastening devices with which the orthopedic device, e.g. orthosis or prosthesis, can be secured to a limb, and with an actuator, which is secured to the upper part and the lower part at fastening points and influences a pivoting of the upper part relative to the lower part, and with at least one sensor coupled to a controller which activates or deactivates an adjustment device for adjusting an extension stop that limits a maximum joint angle, provision is made that the extension stop, in accordance with sensor data, is moved from a starting position, in which the upper part is located in a position of flexion relative to the lower part, to an end position, in which the upper part is located, relative to the lower part, in a position different than the starting position, in particular a position of extension. In addition to being mechanically limited, the extension stop can also be limited or changed by a change of a hydraulic system, for example by the controlled opening and closing of valves or blocking devices which prevent further movement of a piston inside a cylinder in a predetermined position, but a position that can be changed on the basis of sensor data.
The maximum possible joint angle is therefore not fixed and instead can be adjusted. The starting position initially set is a maximum joint angle which is flexed, i.e. which provides a flexion of for example the orthotic knee joint. The maximum joint angle is below the maximum extension position of 180°, i.e. a perpendicular orientation of the longitudinal extent of the upper part relative to the lower part. In principle, a hyperextension is also possible as the maximum joint angle. In the case of an orthotic knee joint, hyperextension is present when the rear aspect of the lower leg relative to the rear aspect of the thigh is at an angle of more than 180°; hyperextension of the elbow joint is present when the forearm is extended from the biceps side of the upper arm by an angle of over 180° or the forearm encloses on the triceps side of the upper arm an angle of less than 180°. This method takes account, for example, of a change in the physiological circumstances of a patient in the course of wearing the orthosis. Whereas the movement range may be reduced in the mornings on account of a flexion contracture, i.e. the maximum joint angle that the patient can perform with respect to a maximum extension is located in a flexed position, the flexion contracture can decrease by the movement during the day. If the extension stop were to remain static, too great an extension stop would be set in the mornings, and this would lead to the tissue structures of the patient being overstrained. In addition, problems can arise in the control of orthoses, in which the extension stop is used as a trigger signal. If the extension stop were to remain set at the level of the flexion contracture in the mornings, this would indeed provide permanent signal triggering when the extension stop is reached upon each complete movement, but it would reinforce the flexion contracture and in addition would mean a loss of comfort.
However, if an automatic adjustment of the extension stop is made on the basis of sensor data, it is possible, on the one hand, to take account of changes in the range of movement over the course of a day and, on the other hand, to take account of changes or progress in the state of health, in particular if the range of movement increases. Thus, over a long period of observation of sensor values such as joint angle, forces, moments, accelerations, spatial positions or also myoelectrical or other physiological signals, it is possible to determine whether the user has made progress in terms of mobility and the respective range of movement, such that over a longer period of time, for example several months, the maximum extension stop is shifted to the limit at which the anatomically maximum extension is achieved. In addition, information made available by the sensor or the sensors can be stored over a predefined period of time and evaluated, so as to be able to be used for documentation purposes. In this way, for example, therapeutic progress can be documented.
The sensor data can be detected over a period of time and compared with a threshold value, wherein the adjustment of the extension stop takes place only when the threshold value is reached over a defined period of time. Instead of a measurement at just one instant, the sensor or sensors are able to detect a large number of data items or data profiles and compare them with a threshold value, which has to be reached over the specific defined period of time. It is only when a mobility level or extension level is achieved over a certain period of time that an adjustment of the extension stop in the direction of increasing extension is made, so as to prevent a situation where the detected situation to be assessed is a statistical outlier or involves an atypical movement of an incorrect measurement.
The maximum joint angle can be set and is set in such a way that the movement range of the orthosis is within the limits that are medically acceptable and that are within the anatomical capacity of the respective patient. In accordance with the respectively measured joint angle, the extension stop can be adjusted as far as the maximum attainable joint angle or the therapy goal. The respectively measured joint angle is compared with a setpoint value, threshold value or limit value. The setpoint angle, threshold value or limit value can be slowly adapted over a long period of time, for example by continuous averaging of the measured angle. The changing of the extension stop ends when the predefined maximum joint angle is reached as the defined threshold value, in order to prevent hyperextension of the anatomical structures. The extension stop can also be adjusted on the basis of evaluation of the transmitted joint moment or the transmitted forces at a predefined time. For example, it can be determined that, in the case of an orthosis, a defined moment has to be transmitted by the orthosis in the extended position of the knee joint when walking in one plane. If the moment actually transmitted is too low, this is an indication of possible overloading of the anatomical structures, from which it is possible to infer that the extension stop of the orthosis would have to be adjusted in order for the stop to be effected at a lower joint angle. If the transmitted moment is very high, this can be an indication that the orthosis reaches the extension stop too early, the knee joint could therefore go further in extension, with the orthosis blocking the movement too early. A desired extension effect for the patient is thus not achieved, and the movement cannot be executed fully and correctly, as a result of which the orthosis system as a whole would be inadequate. If very high forces or moments are found in the orthosis when the extension stop is reached, this can lead to the shifting of the extension stop in a direction of an increased joint angle.
Alternatively or in addition, in the adjustment of the extension stop, it is ascertained whether and to what extent, in defined movement phases, a threshold value for the moment effective about the joint axis or for the forces effective between the upper part and the lower part is reached or exceeded. For this purpose, when the instantaneous extension stop is reached, the moment effective about the joint axis or the forces effective between the upper part and the lower part are measured and, if a threshold value is exceeded, the extension stop is shifted in the direction of its end position. If the threshold value is not reached, the extension stop can be shifted in the opposite direction, i.e. the maximum attainable joint angle can be reduced, for example in order to ensure that the extension stop is reached in every complete movement, without overstraining or placing a very heavy load on the anatomical structures. The establishment of defined movement phases prevents undesired adjustment in the event of randomly occurring high moments, for example in the event of stumbling.
It is moreover possible that resistance values of the actuator during the pivoting movement are detected and are correlated with sensor values concerning the joint angle and the forces and/or moments prevailing between the upper part and the lower part. The adaption or adjustment of the extension stop thus takes place on the basis of a relationship between joint angles, moments or force profiles and resistance values. Anatomical joints do not generally have a hard extension stop, and instead they show a certain elasticity on account of ligaments, tendons and capsules around the extension stop. In certain movements, for example in swing phase extension or stance phase extension during walking, this elasticity leads to a characteristic angle-moment profile. The extension movement is braked beyond the extent influenced by the aid itself. According to the invention, the angle range and the moments are determined and are compared with a characteristic angle-moment profile. If the characteristic angle-moment profile is not reached, this is an indication that the extension stop has to be adapted. Thus, for example for the knee joint in the swing extension phase during walking, it can be determined whether the joint is braked strongly in an angle range before the end stop, although the orthosis with the actuator offers a constantly low resistance. It is thus possible to estimate where the natural end stop lies. The position of the extension stop can then be adapted automatically, such that this effect occurs shortly before the end stop, in order to achieve a movement profile that is as natural as possible.
The extension stop is preferably adjusted auto-adaptively, i.e. on the basis of measured sensor values and without the intervention of a patient or orthopedic technician based on previously established criteria. For this purpose, the sensors detect information that forms the basis for the assessment of a possible change of the orthosis property, in particular of the extension stop. In addition to measured values detected by sensors, it is also possible to use calculated or estimated parameters and states of the system, i.e. of the orthosis, together with the patient; these can be parameters and states from over a past period of time and also current parameters and states. Besides angles, moments, forces or spatial positions of upper part and lower part or spatial positions of limbs, there is additionally information concerning the duration of wear, the time of day or the profile of the previous adaptation, for example in which periods of time which changes of the extension stop in the direction of an increasing maximum joint angle or a decreasing maximum joint angle had been achieved. To this extent, evaluation of electromyography sensors may be expedient, in order to draw conclusions regarding the activity of the residual musculature and any existing spasticity.
In a control device with a computer unit in which sensor data and other information items are processed and optionally stored, the existing information items are processed, compared with one another and correlations determined, for example the determination of the joint moment from a joint angle and a hydraulic force in the actuator, taking account of the geometric conditions present in the orthosis. These information items are combined into one or more criteria, and in each case the period of observation forming the basis of the assessment can vary depending on the intended use. In addition, different periods of observation can be applied for different information items, for example sensor data of the current gait cycle, and an adaptation of the extension stop over the last hundred or more steps. From this, it is possible to derive criteria such as extreme values, average values, differences, integral standard deviation, or more complex features such as data series, typographies, correlations. The criteria are then assessed or compared with reference values which, among other things, can be based on patient-specific data. The assessment can take place using classification methods such as neural networks, machine learning or pattern recognition. In an assessment device, the characteristic variables determined from the sensor data are used as a basis for deciding whether and to what extent a change of the extension stop is necessary and how great this change should be.
For carrying out the method, the extension stop can be achieved by a displacement of the fastening points or by any other change, e.g. by controlled blocking of hydraulic lines, by changing the position of the piston rod, by setting mechanical end stops, or by other changes to the joint device, the upper part, the lower part and/or the actuator.
Illustrative embodiments of the invention are explained in more detail below with reference to the accompanying figures, in which:
An actuator 50 is secured to the upper part 10 and lower part 20 at fastening points 15, 25. In the illustrative embodiment shown, the securing is effected via force-transmitting interfaces 51, 52, which can be designed as carrier plates, parts of the upper part 10 or lower part 20, adapter plates, frame structures or the like. Provision is also made for the actuator 50 to be fastened directly to the upper part 10 and lower part 20 without interposition of force-transmitting interfaces 51, 52, as will be explained below. The actuator 50 according to
It will also be seen from
An alternative embodiment of an adjustment device 100 is shown in a detailed view in
Alternatively, at different positions on the upper part 10 or on the force-transmitting interface 51, fastening devices 76 can be arranged with which either the actuator 50 or the joint device 30 can be secured to the upper part 10. By virtue of the large number of fastening devices 76 on the upper part 10 or on the force-transmitting interface 51, different actuator models with different displacement paths and movement ranges can be secured to the orthopedic device.
The middle view in
Variants of the invention are shown in
Alternatively or in addition to the mechanical extension stop 110, a control valve 59 can be arranged in a hydraulic line 58 leading from an extension chamber to a flexion chamber, which control valve 59 is driven by motor, such that the control motor or the control device forms the adjustment device 100, which is coupled to a controller 90. Depending on one or more measured values, for example a measured joint angle and/or a transmitted moment or interaction force, which are detected for example via a sensor 80 or several sensors 80, the hydraulic valve 59 is opened or closed via the controller 90. For example, if the extension stop is intended to be at a joint angle of 170°, the hydraulic valve 59 is closed upon attainment of a corresponding angle or corresponding orientation of the upper part 10 relative to the lower part 20 or of the first force-transmitting interface 51 relative to the second force-transmitting interface 52. A further displacement of the piston 57 inside the cylinder in the hydraulic actuator 50 is prevented, such that an extension stop is effectively formed. In addition to an embodiment of the sensor 80 as an angle sensor, it can also be configured as a force or moment sensor or as a sensor for detecting the spatial orientation of an upper part or lower part, or any desired combination of these sensors. To detect the spatial orientation, a so-called inertial angle sensor is provided, which can be arranged on the upper part or the lower part. It is also possible, with two inertial angle sensors, to determine the relative position of the upper part to the lower part and to send a corresponding control signal from the controller 90 to the adjustment device 110, so as to open or close the valve 59.
Both the hydraulic embodiment of the extension stop 110 and the mechanical embodiment of the extension stop 110 within an actuator, and also the displacement of the fastening points 15, 25 on the upper part 10 and/or lower part or on a force-transmitting interface 51, 52 or an adapter 70, can be combined with one another, and any desired combinations of the respective adjustment devices and adjustment mechanisms are possible.
A further variant of the invention is shown in
In addition to a displacement of the fastening points 15, 25 as such, it is possible to alter the length of the actuator housing 55, for example by the latter being designed to be variable in length via a screw sleeve, similar to a change of length of the piston rod 56 as described with reference to
By means of an orthopedic device 1 as has been described above with reference to the figures, it is possible to change the effective range of movement of the upper part 10 relative to the lower part 20 about the joint axis 40. The range of movement of the actuator 50, which can be designed to be purely passive or can also be designed as a drive, is influenced, for example, by adjustment of a mechanical extension stop, by displacement of the position of the actuator, by adjustment of fastening points 15, 25 relative to each other or to the joint axis, or by opening or closing hydraulic valves or hydraulic stops. Regardless of the way in which the extension stop is formed, the change of the extension stop can be effected for example on the basis of the joint angle and of the measured moment about the joint axis 40. By way of the measured moment and the measured angle, it is possible to detect whether the joint device 30 reaches the predefined joint angle with the predefined force. In an embodiment of the orthopedic device as an orthosis, it is by this means possible, for example, to determine how great is the muscle activity of the treated limb or of the treated body part. For example, it can be determined whether sufficient extension is applied by the thigh extensor muscles in order to move the lower part to the extension stop. The reaching of the extension stop can be used as a further control signal. With the orthopedic device described, it is possible to adapt the orthopedic device to temporal changes of the demands on the orthopedic device, for example to detect changed anatomical and physiological conditions and to adjust an extension stop if, in the course of use of the orthopedic device, a flexion contracture subsides, or if it is detected that, over a certain period of time stored in the controller, the extension stop is not reached despite the movement patterns being otherwise unchanged. This can point to damage having occurred, to fatigue having set in, or to other problems that have to be responded to during the use of the orthopedic device and that can indeed be responded to using the orthopedic device described. The change of the range of movement, in particular of the extension stop and therefore of the position of the lower part relative to the upper part, can take place automatically if defined criteria are met or are not met. An orthopedic device is thus obtained that adapts autonomously.
The sensor data are not limited to angle data or spatial position data and instead can also include forces or moments. It is possible for several sensors to be assigned to the orthopedic device. It is likewise possible that physiological data, for example electromyography sensor signals, are detected and are used to control the orthopedic device for adjusting the extension stop or the orientation of a limb relative to a lower part. By means of the predefined control data, it is possible to adjust the extension stop auto-adaptively, without a patient or an orthopedic technician having to carry out an adjustment. The auto-adaptive adjustment is effected via the adjustment device, which is driven and, in accordance with sensor data, adjusts the orthopedic device and the respective desired extension angle.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10 2017 131 319.2 | Dec 2017 | DE | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2018/085781 | 12/19/2018 | WO |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2019/129563 | 7/4/2019 | WO | A |
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| Number | Date | Country | |
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| 20210113415 A1 | Apr 2021 | US |
