DEVICE AND METHOD FOR DETERMINING AN INCORRECT POSITIONING IN THE ALIGNMENT OF PROSTHESES

Abstract

The invention relates to a method and a device for determining an incorrect positioning in the alignment of prostheses for the lower extremities, said method comprising the following steps: determining inertial measurement data and/or variables derived therefrom by means of at least one inertial sensor, over at least one walking cycle, for an extremity provided with a prosthesis; and comparing the inertial measurement data that has been determined and/or the variables derived therefrom with desired values and/or with measurement data that has been determined or variables derived therefrom for the corresponding extremity that is not provided with the prosthesis.

Claims

1-10. (canceled)

11. A method for determining positions for alignment of a lower extremity device or selection of components of the lower extremity device, the method comprising: providing at least one first inertial sensor for use on a treated extremity of a user, and at least one second inertial sensor for use on an untreated extremity of the user; determining inertial measurement data and variables for the treated extremity using the at least one first inertial sensor over at least one gait cycle; determining intended inertial measurement data and intended variables for the untreated extremity using the at least one second inertial sensor over at least one gait cycle; comparing the inertial measurement data and the variables with the intended inertial measurement data and intended variables; selecting, based on the comparing to establish a harmonic gait pattern, different components of the lower extremity device or determining positions for alignment of the lower extremity device based on the comparing to establish a harmonic gait pattern and to determine modifications to be made in the alignment to achieve the harmonic gait pattern.

12. The method of claim 11, wherein the inertial measurement data includes absolute angles, the absolute angles being used to determine alignment of the lower extremity device.

13. The method of claim 11, wherein the lower extremity device includes a lower leg part and a thigh part, the lower leg part and the thigh part each having absolute angles determined by the at least one first inertial sensor, the method further comprising: determining the knee angle from the absolute angles of the lower leg part and of the thigh part; comparing the knee angle to intended knee angle values determined from the at least one second inertial sensor.

14. The method of claim 11, further comprising: determining an angle of a component of the lower extremity device using the at least one first inertial sensor; outputting, with an output device, a deviation message when the angle of the component deviates from an intended value determined using the at least one second inertial angle sensor, or outputting a confirmation message when the angle of the component matches the intended value.

15. The method of claim 11, further comprising: establishing, with the at least one first inertial angle sensor, a pelvic angle in a frontal plane; outputting, with an output device, an error message if the pelvic angle exceeds a limit value.

16. The method of claim 11, wherein the inertial measurement data and the intended inertial measurement data is established over a plurality of gait cycles.

17. The method of claim 11, further comprising: providing, with an output device, a recommendation for adjustment of the lower extremity device based on the comparison.

18. The method of claim 11, wherein the inertial measurement data comprises at least one of linear accelerations of the lower extremity device and angular rates or angular velocities of the lower extremity device.

19. The method of claim 11, further comprising establishing the inertial measurement data over a plurality of gait cycles.

20. A method to determine positions for alignment of a lower extremity device or selection of components of the lower extremity device, comprising: establishing, using sensor data measured by at least one first inertial sensor associated with a treated extremity of a user, over at least one gait cycle, inertial measurement data; establishing, using sensor data measured by at least one second inertial sensor associated with an untreated extremity of a user, over at least one gait cycle, intended inertial measurement data; comparing the inertial measurement data with the intended inertial measurement data; selecting, based on the comparing to establish a harmonic gait pattern, different components of the lower extremity device or determining positions for alignment of the lower extremity device based on the comparing to establish a harmonic gait pattern and to determine modifications to be made in the alignment to achieve the harmonic gait pattern.

21. The method of claim 20, further comprising: establishing variables derived from the inertial measurement data for the treated extremity; establishing intended variables derived from the intended inertial measurement data for the untreated extremity.

22. The method of claim 20, further comprising outputting, with an output device, a deviation message when the inertial measurement data deviates from the intended inertial measurement data, or outputting, with the output device, a confirmation message when the inertial measurement data matches the intended inertial measurement data.

23. The method of claim 20, further comprising determining, with the at least one first inertial sensor, a pelvic angle in a frontal plane, and outputting an error message if the pelvic angle exceeds a limit value.

24. The method of claim 20, wherein the inertial measurement data and the intended inertial measurement data is established over a plurality of gait cycles.

25. The method of claim 20, further comprising: providing, with an output device, a recommendation for adjustment of the lower extremity device based on the comparison.

26. The method of claim 20, wherein the inertial measurement data comprises at least one of linear accelerations of the lower extremity device and angular rates or angular velocities of the lower extremity device.

27. A lower extremity device, comprising: at least one first inertial sensor connected to a treated extremity of a user and configured to generate treated extremity sensor data during a gait cycle; at least one second inertial sensor connected to an untreated extremity of the user and configured to generate untreated extremity sensor data during the gait cycle; a comparator to compare the treated extremity sensor data to the untreated extremity sensor data, the comparison used to determine whether a harmonic gait pattern exists or to select different components of the lower extremity device.

28. The lower extremity device of claim 27, wherein components of the device are adjustable or replaceable to alter an alignment of the device, and the lower extremity device includes a lower extremity prosthetic device configured to mount to the treated extremity.

29. The lower extremity device of claim 27, wherein the device establishes, using the treated extremity sensor data, at least one of inertial measurement data and variables derived from the inertial measurement data, and establishes, using the untreated extremity sensor data, at least one of intended inertial measurement data and intended variables derived from the intended inertial measurement data, the comparator to compare the inertial measurement data or variables to intended inertial measurement data or the intended variables.

30. The lower extremity device of claim 29, wherein the lower extremity device determines positions for alignment of the lower extremity prosthesis based on the comparing to establish the harmonic gait pattern and to determine modifications to be made in the alignment to achieve the harmonic gait pattern.

Description

[0023] In the following, the invention will be explained in more detail on the basis of the figures. In detail:

[0024] FIG. 1 shows a schematic illustration of a prosthesis with a foot set too far in the anterior direction;

[0025] FIG. 2 shows a heel strike with a foot too far in the posterior direction;

[0026] FIG. 3 shows a toe off with a foot too far in the anterior direction; and

[0027] FIG. 4 shows a toe off with a foot too far in the posterior direction.

[0028] FIG. 1 shows a prosthesis 1 with a prosthetic foot 2, a lower leg tube 3 attached proximally thereto and a socket 4 which establishes a connection to the remaining lower extremity 6. The socket 4 protrudes beyond the still remaining knee joint, and so a knee rotation axis 5 is partly covered. The depicted exemplary embodiment depicts a transtibial prosthesis which does not have a prosthetic knee joint. In principle, the following explanations also apply to transfemoral prostheses with a prosthetic knee joint.

[0029] The prosthetic foot 2 is arranged displaceably relative to the lower leg socket 3, for example by means of a displacement adapter or by means of a slot guide (not depicted here), such that, in addition to a rotation around the longitudinal extent of the lower leg tube 3, there can also be a displacement of the prosthetic foot 2 in the anterior direction in the movement direction or in the posterior direction against the movement direction. An inertial sensor 8 in the form of an inertial angle sensor is arranged or worked into the socket 4, by means of which inertial angle sensor the absolute angle of the prosthesis, in the present case of the socket 4 and of the lower leg tube 3, can be established relative to the vertical. Angle sensors which establish the absolute angle relative to the gravitational direction are, in particular, provided as inertial sensors; provision can likewise be made for accelerometers and/or angular rate sensors for recording the inertial measurement data.

[0030] By applying further inertial sensors, for example on the thigh and on the hips, it is possible to measure certain body segment angles and/or accelerations in a dynamic fashion. In the case of the angles, these are, in particular, the orientation of the thigh, the orientation of the lower leg, the orientation of the hip and the flexion of the knee from the difference angle between the thigh angle and the lower leg angle in the sagittal plane. A step identification, which admits a temporal assignment of the measured angle values to the respective gait phase, can be realized on the basis of these measured or calculated angles. Therefore, it is possible to achieve a time-resolved angle registration for the standing phase and the swing phase during walking. As a result, it is possible to depict the angle profiles of the respective body segments over a gait cycle, or else over a plurality of gait cycles, and to compare these angle profiles to those of a predetermined intended curve or to values measured at the contralateral, untreated leg. It is also possible to measure the linear accelerations which occur along the axes of a reference system, just as it is possible to measure the angular rates or angular velocities around the respective axes in order to be able to derive the rotational movements therefrom.

[0031] A critical parameter when fitting transtibial prostheses lies in sufficient knee flexion and sufficient knee extension after the heel strike. This parameter can be substantially influenced by the positioning of the prosthetic foot 2 relative to the lower leg tube 3 and therefore relative to the socket 4. A change in the positioning of the prosthetic foot 2 in the anterior/posterior direction leads to a change in the profile of the floor reaction force 7 during striking, heel-toe walking and at the end of the standing phase during toe off. This change in the profile results in a change in the effective knee torque around the knee axis 5 which has a stretching or flexing effect depending on the position of the floor reaction forces 7 relative to the joint axis 5.

[0032] In FIG. 1, the prosthetic foot 2 is displaced maximally in the anterior direction such that, in the case of the heel strike at the beginning of the standing phase, the vector of the floor reaction force 7 is arranged anteriorly to the knee rotation axis 5. This leads to a stretching torque around the knee rotation axis, and so no knee flexion, or only little knee flexion, can be established during the heel strike. If the patient exhibits no knee flexion while walking in a straight line in the plane after the heel strike, but rather there is detection of stretching and, accompanying this due to the non-existent deflection, a pelvic tilt in the frontal plane after the heel strike, an orthopedic technician can deduce that the prosthetic foot 2 is arranged too far in the anterior direction, and so an adjustment in the posterior direction is required. This setting can be brought about iteratively until the desired knee angle is achieved during normal walking.

[0033] FIG. 2 shows the maximum position of the prosthetic foot 2 in the posterior direction; in the case of a heel strike, the vector of the floor reaction force 7 extends behind the knee rotation axis 5, and so there is very strong flexion due to the inflected knee torque. This unwanted knee flexion must be absorbed by the patient using the treated leg, which is disadvantageous. Therefore, the orthopedic technician will analyze the angle profile after the heel strike and will determine that there is a knee flexion which is too strong or too quick, and hence there is a displacement of the socket 4 relative to the vertical which is too quick. This leads to the prosthetic foot 2 having to be displaced further in the anterior direction until the patient starts to flex the knee in a controlled manner.

[0034] Determining the set-up by means of the heel strike is made simpler if the knee angle is available as a measurement value, and so additional inertial angle sensors 8 would have to be arranged on the thigh. The knee angle is calculated by forming the difference between the segment angles from the thigh and lower leg in the sagittal plane. A recommendation in respect of the direction in which the prosthetic foot needs to be displaced can now be provided on the basis of the measured knee angle curve or, optionally, also on the basis of only the measured lower leg curve for a plurality of steps. This recommendation can be brought about by means of an output apparatus 10 on a comparator 9, which is connected to the sensor 8 or the sensors 8. The measured angles are processed within the comparator 9 and the output command or output value is established, optionally on the basis of intended curves or measured angle values of the contralateral, untreated leg.

[0035] A further indication as to whether or not the prosthesis set-up is appropriate can be effected during the toe-off phase, the so-called toe off, which is depicted in FIGS. 3 and 4. In the case of an orientation of the prosthetic foot 2 which is too far in the anterior direction in accordance with FIG. 3, a knee-extending torque is exerted anteriorly of the knee rotation axis 5 due to the profile of the resulting floor reaction force 7, and so inward flexion after the toe off is not possible, or only possible with difficulties. Accordingly, it is necessary to position the prosthetic foot 2 further in the posterior direction.

[0036] If the prosthetic foot 2 is too far in the posterior direction, as shown in FIG. 4, the resulting floor reaction force vector 7 extends posteriorly of the knee rotation axis 5 during the toe off, which leads to a sudden and uncontrolled inward flexion or to an increased load on the patient in the case of a transtibial prosthesis. If no knee flexion or no sufficiently large increase in the initial angle of the socket 4 and of the thigh is determined during the toe off, or just thereafter, the assumption can be made that the positioning is too far in the anterior direction, while in the case of a quick angle enlargement and a very far swing-through and a sudden inward flexion, the assumption can be made that the positioning is too far in the posterior direction, and so an appropriate adjustment becomes necessary in order to compensate for this. On the basis of the established values, a signal as to whether the set-up corresponds to the prescriptions or whether changes, and which changes, need to be undertaken, i.e. whether there should be a displacement in the anterior or posterior direction, is output by means of the output apparatus 10.

[0037] A physiologically correct gait is, inter alia, characterized in that the segment angles of thigh and lower leg of both legs describe an almost identical motion cycle and scope of movement during normal walking in a plane. If, in the case of a prosthesis wearer, the prosthesis-side thigh angle has a reduced scope of movement in the sagittal plane, this can be an indication for a flexion contracture not considered during the prosthesis set-up. Thus, if the scope of movement of the right and of the left thigh of the patient is measured directly during walking by means of inertial sensors, it is possible to establish different scopes of movement due to the deviating inertial angle during a gait cycle or during a step. To the extent that it is the prosthesis-side scope of movement that is less, an indication in respect of a flexion contracture being present is output by means of the comparator 9 and the output apparatus 10, and so the prosthesis set-up must be modified accordingly.

[0038] Arranging an inertial angle sensor 10 in such a way that a pelvic tilt in the frontal plane can be established during walking can, if the predetermined angle is exceeded, optimize the prosthesis set-up by a further adduction of the socket 4.

[0039] If the lower leg tube 3 or the socket 4 of the treated side experiences a rotational vibration during the swing phase, this is an indication for an incorrectly set external rotation angle of the knee rotation axis 5. This means that, in the case of transfemoral prostheses, the knee rotation axis 5 does not extend orthogonally to the movement direction of the thigh such that the lower leg experiences a dynamic imbalance. If an imbalance is measured due to the high vibration frequency of the flexed lower leg, this is an indication for an incorrect alignment of the knee rotation axis 5, and so a corresponding correction of the set-up must be undertaken.

[0040] In the case of transtibial prostheses, a sufficient flexion of the knee joint may be present if the knee flexion present is greater than 5, if the knee angular velocity is less than 100/s and the extension of the knee in the standing phase is greater than half of the knee flexing angle. If a sufficient flexion is not determined in the knee joint, the prosthetic foot 2 should be positioned iteratively in the anterior direction until an easily controllable movement of the knee occurs. The determination in respect of the approximately physiological knee angle can be effected by an acoustic signal by means of the output apparatus 10; in the case of measurement values outside of determined parameters or away from the symmetry values of the contralateral leg, a negatively sounding signal may be emitted or an optical warning apparatus may be activated.

[0041] In the case of transfemoral prostheses, it may be the case that a hip flexion contracture becomes more noticeable when walking than it was in the patient history. In order to establish this, the thigh angle movement when walking is measured on the prosthesis side and contralaterally in the sagittal plane. In the case of a smaller movement on the prosthesis side, for example less than 70% of the angular values for the contralateral side, the socket flexion within the prosthesis is increased until the extent of movement is harmonized.

[0042] A further problem of transfemoral prostheses may lie in the fact that the capability of the gluteus medius is weaker than determined in the patient history. The external rotation of the knee axis is then less than what is actually required for the individual style of the gait. In order in this case to determine errors in the prosthesis set-up, the pelvic angle is measured while walking. If a tilt of the hip for positioning the body's center of gravity over the prosthesis, or if a sinking of the hip on the contralateral side, is measured, for example as more than 5 in relation to the horizontal, the abduction angle is increased incrementally until the patient no longer departs from a pelvic tilt in the range of 5 when walking.

[0043] An inertial angle measurement on the lower leg is likewise performed in order to rotate the socket 4 about the longitudinal axis thereof or in order to rotate the pendulum motion of the lower leg in the frontal plane. If an angle movement of e.g. greater than 5 is measured during walking in the plane, the knee axis 5 is incrementally rotated outwardly until the angular movement remains in a tolerable range.