The invention relates to a method for controlling a prosthesis or orthosis of a lower extremity, having an upper part and having a lower part which is connected to the upper part via a knee joint and is mounted so as to be pivotable relative to the upper part about a joint axis, wherein there is arranged between the upper part and the lower part an adjustable resistance device by means of which, during walking, a flexion resistance is changed on the basis of sensor data in an early and mid stance phase after initial heel contact up to the mid stance phase.
Artificial knee joints are used in prostheses and orthoses as well as in exoskeletons as a special case of orthoses. An artificial knee joint has an upper part and a lower part which are mounted so as to be pivotable relative to one another about a joint axis, the knee axis. In the simplest case, the knee joint is in the form of a single-axis knee joint, in which, for example, a pin or two bearing points arranged on a pivot axis form a single knee axis. Also known are artificial knee joints which do not form a fixed axis of rotation between the upper part and the lower part, but have either sliding or rolling surfaces or a plurality of link bars connected together in an articulated manner. In order to be able to influence the movement properties of the knee joints and obtain a movement behavior of the orthosis or prosthesis, or of the exoskeleton, that emulates natural gait behavior, there are provided between the upper part and the lower part resistance devices by means of which the resistance can be changed. Purely passive resistance devices are passive dampers, for example hydraulic dampers, pneumatic dampers, or dampers that change the movement resistance on the basis of magnetorheological effects. There are also active resistance devices, for example motors or other drives, which, via a corresponding connection, can be operated as generators or energy stores.
The knee joints, that is to say the prosthetic joints or orthotic knee joints, are fixed to the patient by attachment means. In the case of prosthetic knee joints, fixing generally takes place by means of a thigh socket, which receives a limb stump. Alternative types of fixing are likewise possible, for example by osseointegrated attachment means or by means of belts and other devices. In the case of orthoses and exoskeletons, the upper part and lower part are fixed directly to the thigh and the lower leg. The fastening devices provided for that purpose are, for example, belts, sleeves, cups or frame structures. Orthoses can also have foot parts for supporting a foot or shoe. The foot parts can be mounted in an articulated manner on the lower part.
DE 10 2013 011 080 A1 relates to a method for controlling an orthopedic joint device of a lower extremity, having an upper part and a lower part mounted in an articulated manner thereon, between which there is arranged a conversion device by means of which mechanical work from the relative movement during a pivoting of the upper part relative to the lower part is converted and stored at least in one energy store. The stored energy is re-supplied to the joint device in a time-delayed manner in order to assist the pivoting of the upper part and lower part in the course of the movement. Assistance of the relative movement takes place in a controlled manner. In addition to the conversion device there can be provided a separate damper which is in the form of a hydraulic damper or pneumatic damper and is adjustable, so that, by means of the damper device, the resistance can be influenced both in the flexion direction and in the extension direction during walking.
An artificial knee joint with the maximum extension that is constructionally achievable has a knee angle of 180°, a hyperextension, that is to say an angle of more than 180° on the posterior side, is generally not provided. Pivoting of the lower part posteriorly relative to the upper part is referred to as knee flexion, pivoting anteriorly or in a forward direction is referred to as extension. On initial contact, the foot is placed on the ground at the end of the swing phase at the beginning of the stance phase. When walking on a level surface, a so-called heel strike occurs in most cases, in which the foot is placed down heel first. If the artificial knee joint remains in an extended, straight position during the heel strike, this results in a direct transmission of force into the pelvis, which on the one hand is uncomfortable and on the other hand is in conflict with the natural gait pattern. Therefore, analogously to normal walking on a level surface, a so-called stance phase flexion is allowed in prostheses and orthoses, in which, after the heel strike, the knee joint flexes about the joint axis, optionally against a resistance force via the resistance device.
WO 2015/0101417 A1 discloses a prosthetic knee joint having an upper part and a lower part which are pivotably mounted on one another via a four-limbed joint system. The joint system is mounted on the lower part so as to be pivotable from a starting position against a spring force during a stance phase flexion, wherein the action line of the spring force is so aligned that a moment acting against an inflexion of the joint system is present.
In the control methods known hitherto, it is a problem that the flexion resistance in the stance phase is set permanently, so that it can be difficult in different gait situations to provide a comfortable gait behavior.
The object of the present invention is, therefore, to provide a method for controlling a prosthesis or orthosis of a lower extremity with which an improved gait behavior can be achieved in a simple manner for users with artificial knee joints.
According to the invention, said object is achieved by means of a method having the features of the main claim. Advantageous embodiments and developments of the invention are disclosed in the dependent claims, in the description and in the figures.
The method for controlling a prosthesis or orthosis of the lower extremity, having an upper part and having a lower part which is connected to the upper part via a knee joint and is mounted so as to be pivotable relative to the upper part about a joint axis, wherein there is arranged between the upper part and the lower part an adjustable resistance device by means of which, during walking, a flexion resistance is changed on the basis of sensor data in an early and mid stance phase after initial heel contact up to the mid stance phase, provides that, after the initial heel contact, the flexion resistance is increased to a value at which further flexion is blocked or at least slowed, wherein the temporal profile of the flexion resistance increase and/or the maximum achievable flexion angle is changed in dependence on the inclination of the surface or a height difference to be overcome. The height difference to be overcome is the height of a prosthetic foot or of a foot part or of a foot of a user of the artificial knee joint relative to a foot or a foot part on the contralateral side of the patient in the stance phase thereof, or the height difference relative to the level of the immediately preceding stance phase of the prosthetic foot, of the orthotic foot part or of the foot during walking. In addition to walking on a level surface, normal locomotion also includes walking on ramps, wherein the ramps are walked on both upward and downward, and walking on stairs, wherein in particular walking downstairs is distinguished from walking downward on ramps. It is provided to limit the maximum possible stance phase flexion after initial heel contact to an adjustable angle. Stance phase flexion after initial heel contact is allowed in order to avoid the direct transmission of force into the user's pelvis. The flexion damping is here increased in dependence on the knee flexion angle until a target angle is reached or at least not exceeded. If a target angle is reached in the stance phase, further flexion is blocked. Until then, in the case of an increasing flexion angle or knee flexion angle, which manifests itself as a reduction of the knee angle on the posterior side of the knee joint, is increased, so that, in the case of loads and flexion moments which do not lead to a further stance phase flexion up to the maximum permitted target angle, no blocking of the flexion movement takes place. The temporal profile of the flexion resistance increase and/or the maximum achievable flexion angle is here changed in dependence on the inclination of the surface or, in the case of a gait situation of climbing stairs, a height difference to be overcome. It is thus possible that the user is able to carry out a knee flexion during the stance phase without the risk of no longer reaching complete extension in the stance phase as a result of excessive stance phase flexion. Complex stump control or a conscious use of muscles that are still present is no longer necessary. This allows the user to walk in a very relaxed and effortless manner, in particular at low walking speeds.
A development of the invention provides that the maximum achievable flexion angle and/or the flexion angle at which the maximum flexion resistance is achieved is increased in the case of an increasingly steep surface. When walking downward, it is necessary to catch the body weight when stepping with the assisted side via a stance phase flexion. This is facilitated in that, in the case of an increasingly steep surface, that is to say if it is more steeply downhill, the maximum achievable flexion angle is increased, whereby a longer path for providing sufficient flexibility and a longer path for converting the movement energy into heat or electrical energy or into another energy store is provided. In addition, in the case of an increasingly steep surface, the maximum flexion resistance can be reduced in order to permit a further inflexion and an increase in the maximum achievable flexion angle. Such a larger flexion angle can occur, in addition to when walking on a steep surface, also in the case of so-called braking steps or when walking downstairs. If the maximum achievable flexion angle or the maximum flexion resistance is reached, a more or less developed plateau forms in the temporal knee angle profile, because a further knee flexion is prevented or made more difficult after the target angle has been reached or shortly before a flexion block is reached.
The flexion block or the increased flexion resistance can be maintained for a defined period of time in the plateau phase, and then the flexion resistance can be reduced. The subsequent reduction of the flexion resistance over a defined period of time, which can also be fixed in space by the reaching of an orientation for example of the upper part, of the lower part or of a connecting line between the upper part and the lower part, the flexion damping is lowered again, for example to an initial level of a stance phase damping. In order to generate as few tilting moments as possible in the upper part, the flexion damping is advantageously reduced progressively, wherein the period of time of the reduction can be dependent on the surface inclination or the orientation of the components relative to one another in space.
The flexion resistance can be reduced after the flexion block and after the maximum stance phase flexion angle has been reached or after the flexion resistance increase and after a stance phase flexion angle that is achievable at said resistance has been reached, if a measure of the maximum transverse force in the lower part exceeds a limit value dependent on the inclination of the surface and/or a leg cord exceeds a forward inclination dependent on the inclination of the surface and/or a measure of the hip moment initially exceeds and then falls below a limit value. A measure of the transverse force within the lower part, for example at a lower leg tube or a lower leg splint, is a possible indicator of the instantaneous gait phase. The measure can be the transverse force itself, but it can also be defined in dependence on the transverse force and be, for example, in relation to the known body weight or the body weight determined by means of a sensor on the orthosis or prosthesis. If the transverse force or the measure of the transverse force has exceeded a maximum value dependent on the inclination of the surface, a reduction of the flexion resistance can be initiated. The transverse force is a force component which acts perpendicular to the longitudinal extension of the lower part, in the case of an upright, extended leg the transverse force runs in the anterior-posterior direction in the sagittal plane. The transverse force value can be measured directly by means of a transverse force sensor, which in this variant of the invention is the only force sensor required to carry out the method.
Alternatively or in addition, the flexion resistance can be reduced again after a flexion block and after the maximum stance phase flexion angle has been reached or after the flexion resistance increase and after a flexion angle possible therewith has been reached, if a leg cord exceeds a forward inclination dependent on the inclination of the surface. The leg cord is regarded as being a connecting line between two defined points on the upper part and the lower part or on a component attached to the lower part. A preferred embodiment provides that there is used as the leg cord the connecting line between a hip rotation point and a foot point. In the case of the use of a prosthetic knee joint, the hip rotation point is determined by an orthopedic technician and defines the segment length of the thigh or upper part, which is defined as the distance between the joint axis or knee axis and the hip rotation point. The segment length of the lower part is defined by the distance between the knee axis and a foot point. There can be defined as the foot point, for example, the middle of the foot, the instantaneous center of a rolling movement, the end point of the perpendicular of the lower leg at the level of the sole of the foot part, of the prosthetic foot or on the ground, other points close to the ground are likewise suitable for defining a foot point. Because a foot part for supporting a natural foot that is still present is not necessary in the case of orthoses or exoskeletons, the distance from the ground to the joint axis can also be used. The position and/or the length of the leg cord provide reliable information about the orientation of the leg and the movement progression. The leg cord can be calculated or assessed by means of absolute angle sensors in conjunction with the known segment lengths, an absolute angle sensor and a knee angle sensor. If the leg cord exceeds a forward inclination relative to the surface, movement progression can be concluded therefrom, which allows the flexion block to be removed or the flexion resistance to be reduced further in order that a swing and an initiation of the swing phase can be achieved. The mid stance phase and the end of the mid stance phase are also detected with the exceeding of the forward inclination in dependence on the inclination of the surface. The inclination of the surface can be obtained, for example, from a determined angle in the ankle joint. The surface inclination can, however, also be determined in a different way.
Alternatively or in addition, the flexion resistance can be reduced after the flexion block and after the maximum stance phase flexion angle has been reached or after the flexion resistance increase and after a stance phase flexion angle achievable at said resistance has been reached, if a measure of the hip moment initially exceeds and then again falls below a limit value. The limit value is exceeded and fallen below in a single stance phase. The occurrence of a high hip moment in the stance phase is an indicator of the inclination of the surface, since when walking uphill on a steep ramp, for example, a high flexing hip moment is initially established, which reduces as the step is continued. The same is true for walking upstairs. If an extending hip moment is detected, this is an indicator for walking downhill on a ramp. The extending hip moment reduces as the step is continued in the stance phase, so that, in the case where a limit value is initially exceeded and subsequently fallen below, it is possible to derive the inclination of the surface in order to adjust the flexion resistance accordingly. The hip moment can be calculated by means of a knee moment and the known geometric relationships, by means of the orientation of the upper part in space, or from the orientation of the lower part in space and the knee angle. In addition to the hip moment as such, a parameter based thereon can also be used as a measure for the hip moment, for example a value or a characteristic number which is formed in dependence on the spatial position of the upper part and/or the body weight.
As an alternative to measuring the transverse forces directly, it is possible to determine the measure of the transverse force from a difference between transverse force components of an ankle moment and a knee moment. If the body weight of the user of the artificial knee joint is also taken into consideration for this purpose, the control and flexion resistances can be adjusted in a particularly individual manner.
The flexion resistance can be reduced again after it has been increased if a predefined knee flexion angle is exceeded, wherein the reduction is reduced to a level below a blocking level. The reduction can be reduced, for example, to an initial stance phase damping level, wherein the knee flexion angle can be exceeded in particular on steeper ramps, since the extent of the flexion damping increase is dependent on the inclination of the surface.
The reduction of the flexion resistance in dependence on the transverse force is relevant in particular in the case of braking steps, in particular in the case of braking steps on a level surface and when walking down ramps or stairs. The ramp-inclination-dependent leg cord angle or the forward inclination of the leg cord in dependence on the inclination of the ramp is crucial in particular in the case of shallow ramps or ramps with a moderate gradient in order to avoid excessive hip extension and allow inflection of the knee joint at the correct time.
The inclination of the surface can be calculated from a vertical and/or horizontal distance travelled in the preceding swing phase by the knee joint, in particular by a reference point in the vicinity of the sole of the foot, or from the ratio of a vertical and horizontal distance travelled in the preceding swing phase by the knee joint, but in particular by a reference point in the vicinity of the sole of the foot, as a displacement calculation criterion. For this purpose, sensor signals of an inertial measurement unit, for example, are evaluated and integrated over a defined period of time. This yields velocities and distances travelled, which can be used for calculating the surface inclination. The surface inclination is the ratio of the vertical distance travelled to the horizontal distance travelled. The distance travelled by a point in the vicinity of the sole of the foot, that is to say the distance travelled by a reference point, must here be calculated. For this purpose, the position of the lower part or lower leg part is determined at the beginning and at the end of the integration and, by means of geometric parameters and a simplified angle function, the distance travelled by the reference point or the foot relative to the inertial measurement unit or IMU is calculated.
The beginning of the stance phase to be controlled can be determined on the basis of an axial force impulse, a plantar flexion acceleration and/or an ankle moment. By means of a pure axial force sensor in a foot part or on the lower part, it can be determined when a foot is placed down. After a force-free phase or a phase without axial force, a spontaneous increase in an axial force component is detected and serves as a meaningful indicator of the beginning of the stance phase. Without a force sensor, a plantar flexion acceleration can be determined if the foot part is an articulated foot part or a prosthetic foot is mounted in an articulated manner on the lower part. Likewise, an ankle moment, which acts in the plantar flexion direction, can be determined and, after a moment-free phase effecting a plantar flexion, can be used as the starting point for the stance phase to be controlled.
A variant of the invention provides that the inclination of the surface is calculated from an evaluation of the flexion angle and of an absolute angle of an upper part or of a lower part or from the evaluation of two absolute angles of the upper part and lower part, as a kinematic criterion. The profile of the knee angle is acquired and determined together with an absolute angle of an upper part or of a lower part. Alternatively, the absolute angle of the upper part and lower part is used as the kinematic criterion, and the inclination of the surface is calculated therefrom. After the occurrence or the initial heel contact, different tangential gradients between the inclination of the surface and the knee angle are obtained in dependence on the surface inclination, so that, with knowledge of the particular tangential gradient, it is possible to derive the surface inclination. For that purpose, the knee angular velocity and the lower part angular velocity in space when walking can be determined. The quotient of the two angular velocities is calculated therefrom, wherein the inclination of the surface is determined on the basis of the changes of the quotient of the angular velocities.
Such a kinematic criterion or such a calculation, based on kinematic parameters, of the inclination of the surface can be used together with the displacement calculation criterion by means of the calculation of the vertical and/or horizontal distance travelled, wherein a weighted use of the respective criteria is possible. In addition to the equally weighted consideration of the calculated inclination from the movement of the lower leg and thigh and the calculated inclination on the basis of the displacement calculation data from the signals of an IMU, the kinematic criterion, for example, can be weighted less or used only in specific situations or gait situations as an additional determining parameter or error avoidance measure. For example, in critical situations when walking downstairs, the kinematic criterion can be used, in addition to the displacement calculation criterion, to avoid unintentional blocking or release of the knee joint.
There can be used as a further control parameter the position and/or orientation of a ground reaction force vector in relation to the prosthesis or orthosis. It is likewise possible that the detection of a roll-over of a foot part over an edge prevents a damping increase or further reduces the increased resistance, which is advantageous in particular when walking downstairs in the case of rolling of the assisted leg. The distances travelled for the displacement calculation criterion are calculated in particular from the IMU values of the lower part at the end of the preceding stance phase and at the beginning of the stance phase to be controlled, wherein the distance between the position of the IMU on the orthosis or prosthesis and the respective reference point and also the spatial positions at the end of the stance phase, that is to say at toe-off and on initial heel contact or heel strike, are known. Both the displacement calculation criterion and the kinematic criterion can be used individually for determining the surface inclination, wherein the selectivity of the sensor signals can also be a factor for the application of one criterion or the other criterion.
The starting point and the end point of the displacement integration can be determined by means of a state machine, wherein different sensor signals are monitored for different events, Such an event would be, for example, a loaded roll-over at the edge of a step, which can be recognized by the detection of an axial force with a simultaneous forward inclination at least of the lower part or of the leg cord. A loaded roll-over or a lifting of the orthosis or prosthesis as well as re-loading of the orthosis or prosthesis can likewise serve as a decisive feature for the start and end time of the displacement integration.
Exemplary embodiments of the invention will be discussed in more detail below on the basis of the appended figures. In the figures:
Between the posterior side 12 of the upper part 10 and the posterior side 22 of the lower part 20, the knee angle KA is measured. The knee angle KA can be measured directly by means of a knee angle sensor 25, which can be arranged in the region of the pivot axis 15. The knee angle sensor 25 can be coupled with a torque sensor or can have such a sensor, in order to detect a knee moment about the joint axis 15. On the upper part 10 there is arranged an inertial angle sensor or an IMU 51, which measures the spatial position of the upper part 10, for example in relation to a constant force direction, for example gravitational force G, which points vertically downward. An inertial angle sensor or an IMU 53 is likewise arranged on the lower part 20 in order to determine the spatial position of the lower part while the prosthetic leg is in use.
In addition to the inertial angle sensor 53, an acceleration sensor and/or transverse force sensor 53 can be arranged on the lower part 20 or on the foot part 30. By means of a force sensor or torque sensor 54 on the lower part 20 or on the foot part 30, an axial force FA acting on the lower part 20 or an ankle moment acting about the ankle joint axis 35 can be determined.
Between the upper part 10 and the lower part 20 there is arranged a resistance device 40 in order to influence a pivoting movement of the lower part 20 relative to the upper part 10. The resistance device 40 can be in the form of a passive damper, in the form of a drive, or in the form of a so-called semi-active actuator with which it is possible to store movement energy and purposively release it again at a later time in order to slow or assist movements. The resistance device 40 can be in the form of a linear or rotary resistance device. The resistance device 40 is connected to a control device 60, for example in a wired manner or via a wireless connection, which in turn is coupled with at least one of the sensors 25, 51, 52, 53, 54. The control device 60 electronically processes the signals transmitted by the sensors, using processors, computing units or computers. It has an electrical power supply and at least one memory unit in which programs and data are stored and in which a working memory for processing data is provided. After processing of the sensor data, an activation or deactivation command with which the resistance device 40 is activated or deactivated is outputted. By activation of an actuator in the resistance device 40 it is possible, for example, to open or close a valve or to generate a magnetic field, in order to change a damping behavior.
To the upper part 10 of the prosthetic knee joint 1 there is fastened a prosthesis socket, which serves to receive a thigh stump. The prosthetic leg is connected to the hip joint 16 by way of the thigh stump. On the anterior side of the upper part 10 a hip angle HA is measured, which is marked on the anterior side 11 between a vertical line through the hip joint 16 and the longitudinal extension of the upper part 10 and the connecting line between the hip joint 16 and the knee joint axis 15. If the thigh stump is lifted and the hip joint 16 is flexed, the hip angle HA decreases, for example when sitting down. Conversely, the hip angle HA increases in the case of an extension, for example when standing up or in the case of similar movement sequences.
During a gait cycle when waking on a level surface, the foot part 30 is placed down heel first, the first contact of the heel or of a heel part of the foot part 30 is called heel strike. A plantar flexion then takes place until the foot part 30 rests completely on the ground, the longitudinal extension of the lower part 10 is here generally behind the vertical, which runs through the ankle joint axis 35. When walking on a level surface, the center of mass is then displaced forward, the lower part 20 pivots forward, the ankle angle AA becomes smaller, and there is an increasing load on the forefoot. The around reaction force vector moves forward from the heel to the forefoot. At the end of the stance phase, a toe-off takes place, which is followed by the swing phase, in which the foot part 30, when walking on a level surface, is displaced behind the center of mass or the hip joint on the ipsilateral side, with a reduction of the knee angle KA, in order then, after a minimum knee angle KA has been reached, to be rotated forward in order then, with a knee joint 1 that is generally extended to the maximum, to achieve heel contact again. The force transmission point PF thus moves during the stance phase from the heel to the forefoot and is illustrated schematically in
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Number | Date | Country | Kind |
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10 2020 004 339.9 | Jul 2020 | DE | national |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2021/070283 | 7/20/2021 | WO |