Abstract:
An orthopaedic aid for an extremity includes at least one adjustable element for positioning the orthopaedic aid relative to the extremity. The detector arrangement includes a plurality of indicators for indicating torques generated by the detector arrangement. The detector arrangement is positionable such that a section of the detector arrangement is torque-free. The detector arrangement generates torques arising in two opposite directions in a measuring plane in response to deviations from a stable load position.

Description:
This patent application is the national stage of International Application No. PCT/DE2006/001129, which claims priority to German Application No. 10 2005 031 185.7 filed on Jul. 1, 2005 the entire contents of both applications are hereby expressly incorporated by reference. 
     FIELD OF THE INVENTION 
     The invention relates to an orthopedic aid, in particular a prosthesis for an extremity, with at least one adjustable attachment for producing a desired orientation. 
     The adjustment of orthopedic aids, such as orthoses and prostheses, requires particular care, especially where lower extremities are concerned. Prostheses that have not been correctly set can cause considerable lack of balance of the prosthesis wearer and, in the worst case, can even cause falls and resulting injuries. 
     For the adjustment of orthoses and in particular prostheses, comprehensive measuring devices are known which determine the fit of the orthopedic aid during a stable static load position, by evaluating the forces acting on a support surface and showing these on a suitable display. Such a system is known and in use as LASAR Posture. Unfortunately, such equipment is not always available to orthopedic engineers when making adjustments to orthoses and prostheses. 
     SUMMARY 
     In one embodiment, the present invention is an orthopedic aid for attachment to an extremity. The orthopedic aid includes an adjustable element for positioning the aid relative to the extremity and a position detector for indicating the position of the aid relative to the extremity along a load line. The position detector includes at least one lever having a portion that is moveable in a measuring plane upon the application of a torque force to the lever. The position detector also includes at least one force indicator that measures the amount of torque force applied to the lever. 
     Another embodiment of the present invention is a method of adjusting an orthopedic aid relative to an extremity. The orthopedic aid is positioned relative to the extremity such that one end of a lever is fixed, while a second end of the lever is free to move within a measuring plane. When a load is applied to the orthopedic aid by the extremity along a load line, the torque applied by the extremity is determined by measuring the movement of the free end of the lever. The position of the orthopedic aid relative to the extremity is then adjusted to minimize the torque applied to the lever. Once adjusted, the lever may be locked or fixed in place for normal use. 
     In another embodiment, the present invention is a detector arrangement which is positioned and designed in such a way that a section is torque-free in the desired orientation and during a stable, static load position in a measuring plane, generates torques in the measuring plane during slight deviations from the stable load position, and comprises indicators for indication of torques arising in two mutually opposite directions in the measuring plane. 
     The orthopedic aid according to embodiments of the invention permits verification of the desired orientation on the individual patient because the freedom from torque in the measuring plane can be detected by the indicators. No torque is generated in two mutually opposite directions. Torques are generated in both directions in response to any movements outside the stable static load position. 
     In one embodiment, the detector arrangement has at least one lever that can pivot about a pivot point. The pivot point lies in a load line of the stable load position. The pivot point is optionally positioned at one end of the lever with the other end of the lever being a rotating free end that forms a torque-free section. 
     The detector arrangement can be securely incorporated into an orthopedic aid. During use of the orthopedic aid, the free end is securely connected by a locking means, for example a locking screw, to a structure of the orthopedic aid. The desired orientation of the orthopedic aid is verified by releasing the locking means. For verification of the desired orientation, the orthopedic aid can be released slightly in order to permit the torque-free section to pivot in the measuring plane in both directions. In the event of correct orientation in the measuring plane, preferably forming the sagittal plane, the free end of the lever is moved neither upward nor downward, but instead catches in a position of balance between limited stops of the released locking means. In the event of slight balancing movements of the patient, such as from slight deviations from the stable static load position which result from balancing movements while standing, a corresponding movement of the free end of the lever takes place in both opposite directions. By contrast, if there is a marked deviation from the desired orientation, such as from an incorrect adjustment of the orthopedic aid, the lever will bear firmly on a limit stop upon release of the locking means. As a result, the incorrect adjustment can be identified. After the adjustment of the orthopedic aid has been corrected, the verification process can be repeated. Once the desired orientation is obtained, the locking means can be actuated and the orthopedic aid can be used in a correct setting. 
     In an alternative embodiment, the detector arrangement can include two levers with free ends which are connected to each other at a pivot point. The two levers form torque-free sections in the desired orientation during the stable load position. The indicators can in this case be formed by limit stops that counter-act the relative movement of the free ends. 
     In order to avoid a noticeable movement of the two levers relative to each other, the indicators can be electronic force transducers with which the resulting torques can be measured. 
     Alternatively or additionally, the indicators can be deformable (e.g., elastic) members, which deform upon contact with the free end of the lever or levers, which can eliminate the need for electronic structural elements and of their energy supply. However, these indicators generally require a noticeable movement of the lever or levers such that the detector arrangement may be designed as an exchangeable adapter, which is fitted into the orthopedic aid only for verification of the desired orientation in place of a structural element of the same size. The adapter can then be fitted into the orthopedic aid in a fixed orientation, in order to check the desired orientation. For use of the orthopedic aid, the structural element of the same size is then installed in place of the adapter. 
     Various embodiments of the present invention may be used in orthotics and prostheses attached to extremities, including in particular prosthetic feet and knee joints. Certain embodiment could also be used in other orthopedic aids such as hip joints. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention will be explained in more detail below on the basis of illustrative embodiments depicted in the drawing, in which: 
         FIG. 1  shows a schematic longitudinal section through an artificial foot, with a detector arrangement secured by a locking screw; 
         FIG. 2  shows the view according to  FIG. 1 , with the locking screw released; 
         FIG. 3  shows a schematic representation of a prosthesis with a detector arrangement above a knee joint; 
         FIG. 4  shows a detail of the detector arrangement according to  FIG. 3 . 
     
    
    
     DETAILED DESCRIPTION 
       FIGS. 1 and 2  illustrate a foot prosthesis  1  whose functional structure is accommodated in a cosmetic envelope forming the contour of the foot. A strip-shaped lower sole spring  2  and, arranged above the latter, a control spring  3 , both extend substantially along the length of the foot prosthesis  1 . Both springs  2 ,  3  can be made of a suitable elastic material, for example of a carbon fiber-reinforced plastic. Located above the springs  2 ,  3 , is a generally rigid lever  4 , with an adapter  25  (see, e.g.,  FIG. 4 ), connected to an adjustment sleeve  5  of a lower leg tube part  6 . At the lower end of the adjustment sleeve  5  there are four adjustment screws J with which the position of the adjustment sleeve  5 , and thus of the lower leg tube part  6 , relative to the foot structure can be adjusted. 
     The lever  4  extends from a heel end to a front end of the foot prosthesis  1 . The lever  4  is connected to the control spring  3  and the sole spring  2  at the approximate foot center, with planar dampers  7 ,  8  positioned therebetween. A bolt  9  or similar connection means connects the lever  4  and springs  2 ,  3  such that the lever  4  can execute a pivoting movement relative to the control spring  3  and relative to the sole spring  2 , and the control spring  3  can execute a pivoting movement relative to the sole spring  2 , in the sagittal plane, such that there is an at least reduced freedom of movement in the frontal plane perpendicular thereto. 
     At the heel end of the foot prosthesis  1 , the lever  4  is connected to the control spring  3  by a locking screw  10  or similar means for preventing movement of the lever. Between the control spring  3  the sole spring  2 , a heel damper  11  in the form of an elastic foam block is fitted. When the heel end of the foot  1  is set down, the heel damper  11  is subjected to pressure. When the foot  1  makes a rolling movement over the toe area, the heel damper is subjected to tension. The tensile load is limited by a strap  12  which loops round the outside of the sole spring  2  and the control spring  3  and which does not impede the compression of the heel damper  11 , but does limit the elongation of the heel damper  11  under the tensioning action. At the front end in the toe area, the sole spring and the control spring  3  are connected to each other via another damper  13 . 
     In use, when the heel of foot prosthesis  1  is set down, the heel damper  11  is compressed, as a result of which the position of the lower leg tube  6  of a lower leg prosthesis relative to the sole structure  2 ,  3  pivots rearward causing a desired plantar flexion of the foot relative to the lower leg tube  6 . The control spring  3  acts as a two-armed lever whose heel section is pressed down relative to the heel section of the sole spring  2 , as a result of which the control spring  3  in the forward area of the foot  1  toward the toe area lifts the sole spring  2  and thus imitates a natural toe movement when the heel is set down, which facilitates the rolling movement of the foot. In the rolling movement of the foot past the stand phase, the sole spring  2 , convexly shaped on the underside, is loaded in the forward area of the foot, such that the sole spring  2  in the heel area is pressed down relative to the lever  4 , as a result of which the heel damper  11  is relieved or subjected to tensioning. This load is limited by the strap  12 . 
     The adjustment feature of the illustrated foot prosthesis  1  is based on the fact that the dampers  7 ,  8  and the bolt  9  form a pivot point between the lever  4  and the springs  2 ,  3 , which is located in a perpendicular load line  14  of the patient when standing, as is shown in  FIG. 2 . Accordingly, the center of gravity of the patient is located perpendicularly above the pivot point. If the center of gravity of the patient is not perpendicularly above the pivot point but instead forms an angle with the latter, as is illustrated for the load line  14 ′, a torque is exerted on the lever  4  such that the lever  4  presses with its free end against the upper head of the screw  10 . If, by contrast, the load line  14  is located perpendicularly above the pivot point, the heel end of the lever  4  is unloaded such that the lever  4  is free of torque relative to the pivot point. 
     Accordingly, To check the correct adjustment of the lower leg tube  6  relative to the lever  4 , the locking screw  10  is loosened, such that the heel end of the lever  4  is afforded a vertical range of movement that is limited by an upper limit stop  15 , formed by the screw head  10 , and a lower limit stop  16 , formed here by the heel end of the control spring  3 . If the perpendicular load line  14  is located perpendicularly above the pivot point the heel end of the lever  4  is unloaded and can therefore assume a balance position within the range of movement limited by the limit stops  15 ,  16 . By contrast, if the load line  14 ′ enters the pivot point  7 ,  8 ,  9  at an angle to the perpendicular, the lever  4  is subjected to a torque which, in the case of the load line  14 ′, presses the heel end of the lever  4  against the upper limit stop  15 . The free heel end of the lever  4  will therefore remain on the upper limit stop  15  in the event of a corresponding incorrect adjustment, even if the patient when standing makes the usual balance compensation movements. In this manner, the lever  4  acts as a position detector or detector arrangement. The limit stops  15 ,  16  may also act to provide a visual or electronic measure of the torque force to allow proper adjustment of the leg tube  6 . 
     By contrast, if the adjustment is correct, such that the center of gravity is located within the perpendicular load line  14 , the balance compensation movements of the patient lead to a movement of the heal end of the lever  4  between the upper limit stop and the lower limit stop, as is known from a lever balance. The balance compensation movements, which take place forward and backward in the saggital plane (i.e., in one or two mutually opposite directions in a measuring plane), can be detected from a corresponding upward and downward movement of the heal end of the lever  4  in the movement range, if the adjustment is made correctly. Thus, when the foot prosthesis is correctly positioned relative to an extremity of the patient to which the foot prosthesis is mounted, the lever is free of torque in the measuring plane (e.g., the heal end of the lever  4  is in the movement range). Otherwise, the free end of the lever  4  remains on the one of the limit stops  15 ,  16 , because of the incorrect adjustment. Thus, the locking screw  10  with upper and lower limits stops  15 ,  16  may operate as force indicators and be used to indicate the occurrence of torque in one or two mutually opposite directions in a measuring plane (e.g., the saggital plane). 
     When the correct adjustment has been established, the locking screw  10  can be tightened in order to produce a firm connection of the lever  4  to the sole structure  2 ,  3  and to ensure that the patient does not experience any feeling of imbalance, during walking, as a result of play within the foot structure. 
     Another illustrative embodiment is shown in  FIGS. 3 and 4 . These show the cosmetic envelope  1  of a foot prosthesis and the adjoining lower leg tube  6 . Arranged at the upper end of the lower leg tube  6  there is an artificial knee joint  17 , which connects the lower leg tube part  6  to a receiving funnel  18  for a thigh stump of the patient.  FIG. 3  indicates the perpendicular load line  14  intended to pass through the center of gravity of the patient in the sagittal plane. As shown, the perpendicular load line  14  passes a small distance (e.g., approximately 20 mm) in front of a pivot axis  19  of the knee joint. If used in conjunction with the foot  1  shown in  FIGS. 1 and 2 , the perpendicular load line  14  may also pass through the pivot point previously described. 
     The knee joint  17  is connected securely to the receiving funnel  18  via a securing adapter (not shown). The securing adapter can be equipped with additional functions. To check the adjustment of the prosthesis arrangement, a detector arrangement  20  is fitted between the knee joint  17  and the receiving funnel  18 . The detector arrangement has a lower lever  21  and an upper lever  22 , which are connected to each other at their front ends via a pivot hinge  23 . The lower lever is provided with an adapter bushing  24  with adjustment screws J, in order to produce an adjustable attachment to the lower leg tube part, which is provided on the upper face with an adapter with truncated cone surfaces. The upper lever  22  extends parallel to the lower lever  21  and is provided on its upper face with an adapter  25  via which the receiving funnel  18 , provided on the underside with an adapter bushing part (corresponding to  24 ) for connection to the adapter  25 , can be adjustably attached. 
     The pivot hinge  23  between the two levers  21 ,  22  is arranged in such a way that it is located in the perpendicular load line  14 . The free ends of the levers  21 ,  22  are connected to each other via an interposed central damper  26 , an upper damper  27  mounted externally on the upper lever  22 , and an outer damper  28  mounted on the lower lever  21  A tensioning arrangement  29  with outer contact disks  30  holds the arrangement together such that the dampers  26 ,  27 ,  28  are contacted, but not compressed. If the pivot hinge  23  is located with the pivot axis in the perpendicular load line  14 , the free ends of the levers  21 ,  22  are free of force, such that the dampers  26 ,  27 ,  28  remain uncompressed. 
     By contrast, if the perpendicular load line  14  is arranged dorsally from (i.e., behind) the pivot hinge  23  because of an incorrect adjustment, the two levers  21 ,  22  are pressed against each other at their free ends, such that the central damper  26  is compressed. The compression, leading to a deformation of the central damper  26 , is easily detectable, such that the central damper  26  serves as an indicator of a rearward shifting of the perpendicular load line  14 . 
     By contrast, if the load line  14  is located in front of the pivot hinge  23 , this results in a torque that presses the free ends of the levers  21 ,  22  away from each other, such that the outer dampers  27 ,  28  are compressed, and thus deformed. The outer dampers  27 ,  28  thus serve as indicators of a forward shifting of the load line  14  from the ideal state. 
     It will be readily apparent that the dampers  26 ,  28  can be replaced by electronic force transducers (voltage transducers, acceleration transducers) in order to determine the torques acting on the levers  21 ,  22 . Since these electronic force transducers operate with measurement paths that are imperceptible, such a detector arrangement can remain in the prosthesis during its normal use, since the measurement arrangement does not lead to play in the prosthesis arrangement. 
     The simpler and more economical design of the detector arrangement with the dampers  26  to  28  requires, by contrast, the replacement of the detector arrangement by an adapter insert for normal use of the prosthesis arrangement. 
     In one simple embodiment, the pivot hinge  23  can also be formed by a solid hinge. The indicators can in this case also be formed by switches.