RU2807146C2 - Method for manufacturing orthopedic apparatus of lower extremity for patients with consequences of paralysis of lower extremities - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: method for manufacturing an orthopedic apparatus of the lower extremity for patients with the consequences of paralysis of the lower extremities, which consists in manufacturing, in accordance with medical indications, a lower extremity orthopedic apparatus (LEOA) prescribed to the patient, containing a link for its attachment to the body, a hip link, connected by a hip joint to the axis, a shin link, connected to the thigh link by knee joints with an axis, ankle joints with an axis, connected at the top to the shin sleeves, and the bottom - to the foot link, which has a rigid plantar plate, including the metatarsophalangeal and interphalangeal sections, an electrical stimulator with a power source and cutaneous electrodes, installed in the area of one of the joints, as well as electric drives of hinge joints with axes with a control system and an external energy source. Preliminarily (in the beginning), plaster negatives are made, and from them plaster positives of the thigh and lower leg segments with the foot of the patient’s lower extremity are made. Their centers of mass are determined in projection onto the sagittal plane. A LEOA is manufactured with an electrical stimulator and cutaneous electrodes, and electric drives for articulated joints. The centers of mass of the links of the thigh and lower leg with the foot of the LEOA are determined, and they are combined with the centers of mass of the plaster casts of the thigh and lower leg with the foot, respectively. A simulating device of the lower extremity is manufactured, which has adjustable weight and length parameters of the lower extremity, hip, knee, and ankle axes. The centers of mass of the hip and shin links with the foot of the device are set in accordance with the centers of mass of the plaster positive segments of the hip and shin with the patient’s foot. The frequency of natural vibrations of the links of the lower extremity simulator device is determined. Adjust the position of the leg link with the foot. The frequency of natural vibrations of the lower leg and foot link is determined. The manufactured LEOA is installed on a lower extremity simulator, the frequency of natural vibrations of the lower extremity link with the foot of the lower extremity simulator with the lower extremity link with the LEOA foot is determined, the position of the center of mass of the shin link with the LEOA foot is adjusted by changing the location of the masses of parts and assemblies in the lower leg link and the foot link, knee joint unit, moving the installation site of the drives, bringing the frequency of natural vibrations of the lower leg and hip joint of the knee joint closer to the frequency characteristic of the arbitrary walking pace of an average person with similar medical indications and anthropometric data. The degree of pathological damage to the muscles of the lower extremity is determined and the stiffness of the anterior and posterior hip, knee and ankle elastic elements is selected depending on the degree of damage, in proportion to the degree of damage. Then the rear and front adjustable ankle supports with rear and front counter-supports are installed on the lower leg and foot links. A rear automatic adjustable knee support is installed on the shin link and connected to the control system. A hip link counter support is installed on the hip link at the back. Consoles are installed on the shin and thigh links in front. A rear adjustable hip support is placed at the top of the hip link at the back. A rear body support is installed on the rear surface of the body fastening link. An adjustable stop is installed on the front surface of the thigh link. The fastening link on the body has a front body support. Then the elastic elements are made and installed on the rear and front adjustable ankle pads, on the rear automatic adjustable knee pad, on the console, on the rear adjustable hip pad and the adjustable pad in accordance with the previously determined stiffnesses. The plantar plate is made of a composite material that is rigid in the heel region, arch-shaped in the central part and elastically flexible in the form of plates in the area of the metatarsophalangeal and interphalangeal areas. A knee joint is made with a polycentric axis of rotation in the form of a cycloid, the initial instantaneous point of rotation of which is at least 10 mm away from the instantaneous point of rotation at a flexion angle in the knee joint of 60 degrees. The center of the axis of the hip hinged joint is aligned with the center of the axis of the hip joint. The instantaneous center of rotation of the axis of the polycentric knee hinged joints in the straightened position is combined with the conditional center of the axis of the knee joint in the straightened state, and the centers of the axes of the ankle hinged joints are combined with the centers of the ankle joint axis.

EFFECT: increase in motor functions when a patient walks in a lower extremity orthopedic apparatus (LEOA) with the consequences of spastic, flaccid paralysis, paresis of the lower extremities, accompanied by pathological conditions, contractures in the joints, decreased motor functions, optimization of biomechanical characteristics in the emerging biotechnical system (BTS) LEOA-lower limb, such as the mass-inertial characteristics of the links, the components of the moments of external forces due to the recovery of energy by elastic elements in the hip, knee and ankle joints and the metatarsophalangeal and interphalangeal sections of the foot link, the elimination of immobilization in the metatarsophalangeal and interphalangeal joints of the foot, compliance alignment of the knee hinged joint and the knee joint, elimination of piston movements of the limb in the LEOA, optimization of the construction scheme, which helps to improve motor functions and thereby increase the level of rehabilitation, mobility, activity in everyday life, reduce disability, and severe limitations in life.

1 cl, 13 dwg, 1 ex

Description

The invention relates to medicine, namely to restorative medicine - a method for increasing motor functions when walking in an orthopedic apparatus on the lower limb of patients with the consequences of cerebral palsy, stroke, spina bifida disease, spina bifida, consequences of injuries to the lumbar spine with incomplete spinal cord damage, spinal atrophy of Werdnig-Hoffmann and Dubrovin, Louis-Bart syndrome, some forms of ataxia, myopathy, conditions after reconstructive operations on the lower extremities, multiple sclerosis, traumatic brain injury, postoperative brain damage, toxic encephalopathy, myoplasia, special dysplasias, polyneuropathy, myelitis of various etiologies, poliomyelitis, amyotraphy and some other diseases, lesions of the musculoskeletal system. In this case, manifestations of varying degrees occur: spastic, flaccid paresis, paralysis. At the same time, the patient’s ability to support is impaired, and the ability to move is reduced. Pathological conditions and contractures appear in the lower extremities, muscle tone is disturbed, stiffness occurs, and the entire structure of the limb that is typical for the norm is disrupted. These manifestations also arise as secondary deformations in the absence of proper influence and the failure to carry out complex rehabilitation methods, of which one of the most important is orthosis using orthopedic devices.

At the same time, along with medical indicators, a number of biomechanical characteristics of the lower extremities are disrupted during locomotion, primarily in the sagittal plane. Changes are happening:

- mass-inertial characteristics of the lower extremities due to changes in the masses of the segments, movements of the centers of mass and changes in the position of the joints during walking, which disrupts the frequency of their own pendulum-like movements involved in the functioning of the lower extremity. The mass-inertial characteristics are also violated due to the masses of the links of the orthopedic apparatus installed on the lower limb and the location of their centers of mass, which affects the overall center of mass of the resulting biotechnical system “orthopedic apparatus-lower limb”; a change in the oscillation frequency causes a violation of the arbitrary, least energy-intensive walking pace , due to which motor functions are reduced and the walking pattern is disrupted;

- elastic characteristics of the ligamentous-muscular system in segments and joints of the limbs, leading to a lack of energy recovery, a sharp decrease in the motor functions of the lower limb to ensure walking, disruption of the voluntary least energy-intensive pace of walking, at which the electrical activity of the muscles is minimal;

- amplitudes of motion in the joints, which leads to “looseness” in some and insufficient range of motion in others and, ultimately, to a decrease in motor functions;

- the relative positions of the axes of the joints in the projection onto the sagittal plane during standing and walking, which leads to excessive energy consumption and reduces motor functions, for example, with recurvation or flexion contracture in the knee joint; the relative position of the segments affects both the mass-inertial and elastic characteristics;

- magnitudes, synchronicity of moments of forces relative to the metatarsophalangeal, ankle, knee, hip joints, with a decrease in which the motor functions of the limb sharply decrease, and an imbalance in the movements of the limb occurs.

Thus, pathological manifestations in the lower limb, violating its normal characteristics, significantly reduce the patient’s motor functions, and their increase is required.

There is a known method of increasing motor functions when a patient walks, which consists in manufacturing, in accordance with medical indications, an orthopedic device for the lower limb (LOAL) prescribed to the patient, consisting of an attachment link on the torso, a hip link connected to the hip link by a hip hinge unit, a lower leg link connected to the thigh link with knee hinge units, the ankle joint joints connected by the upper part with the shin link, and the lower part with the foot link, which has a rigid plantar plate, supplying the OANK with an electrical stimulator with a power source and cutaneous electrodes installed in the area of the patient’s knee joint [1].

The known method provides an increase in the moment of force relative to the knee joint, which provides a slight increase in the motor functions of the lower limb when walking.

However, as a result of electrical stimulation, only internal moments of forces arise, while the creation of external moments of forces relative to the hinge joints is not provided for in this method, and electrical stimulation is contraindicated in a number of concomitant diseases. The influence of changes in the affected limb, as well as changes due to the links of the OANK mass-inertial characteristics, disrupted elastic connections in the affected limb on motor functions, is not taken into account. They are not available in the OANK. The construction scheme in accordance with the known method depends only on the condition of the muscles and only in the area of the knee joint and does not take into account the influence of biomechanical, design characteristics, the influence of external moments of forces arising in the biotechnical system (BTS) “OANK-lower limb” when the links of the OANK and limb segments, which contradicts the general approach and leads to incorrect interpretation of the construction scheme. The metatarsophalangeal and interphalangeal joints are immobilized and are not involved in the process of walking in the OANC, which further distorts the design of the OANC, increases energy consumption and reduces motor functions.

There is a known method of increasing motor functions when walking, which consists in manufacturing, in accordance with medical indications, a OANK prescribed to the patient, containing a link for its attachment to the body, a thigh link connected by a hip hinge unit to an axis, a lower leg link connected to the thigh link by knee joint units with an axis, and ankle joints. hinge units with an axle, connected at the top to the shin sleeves, and at the bottom to the foot link, having a rigid plantar plate, including the metatarsophalangeal and interphalangeal sections, an electrical stimulator with a power source and cutaneous electrodes installed in the area of one of the joints, as well as electric drives of the hinge units with axes with a control system and an external energy source [2]. In a known way, an increase in motor functions is achieved by influencing the internal moment of forces relative to one of the joints of the patient’s lower limb and by influencing the moments of external forces of the BTS relative to the hinge joints with axes.

The disadvantages of this method are the lack of determination and adjustment of the location of the centers of mass of the thigh segment and lower leg segment with the foot with the OANK put on them and bringing them to a position that ensures optimization of the period of free oscillations, coinciding with the duration of the locomotor cycle of the step at an arbitrary walking pace, when electric muscle activity is minimal, which minimizes energy expenditure when walking and increasing motor functions requires less expenditure. Another disadvantage of the known method is the lack of provision of motor functions due to the recovery of energy that occurs in the hip, knee and ankle joints under the action of elastic connections and ensures the occurrence of elastic components of the total moments of force in the joints during normal walking. The absence of such an impact in the OANK predetermines an increase in power, dimensions of drives, batteries and the resulting increased mass and energy consumption. In addition, increased dimensions and increased weight negatively affect the ease of use of the OANK. In the known method there is also no optimizing adjustment of the location of the axes of the hinge joints in the projection onto the sagittal plane, depending on the moments of force arising relative to the axes of the hinge joints. Using a rigid plantar platform in the foot, the known method does not provide for movements in the metatarsophalangeal and interdigital joints of the foot and their involvement in the movement process, which significantly increases energy consumption and reduces the motor functions of the lower limb when walking. The absence of movements in the metatarsophalangeal and interphalangeal joints of the foot of the lower limb leads to the absence of a moment of force in the distal joints of the foot in all phases of the step of the support period, including the phase of the rear push, when the provision of a moment of force due to energy recovery in the foot plays a critical role in ensuring motor functions. In addition, the lack of movements leads to the need to fill their role due to the activation of other links, segments of the lower limb, the need for additional drive power and the capacity of an external energy source, leading to an increase in their weight and dimensions. Failure to ensure movement in the metatarsophalangeal and interphalangeal joints of the foot leads to pathological changes in the musculoskeletal system, atrophy of the foot muscles, a sharp disruption of the gait pattern, and all biomechanical characteristics of walking. Another disadvantage is that the known method does not provide for the rotation of the lower leg link relative to the thigh link along the cycloid trajectory, as is done in the knee joint of the lower limb, and the location of the axes of the hip, ankle and metatarsophalangeal hinge joints does not coincide with the axes of the corresponding joints in the projection to the sagittal plane. As a result, there is no shortening of the length of the OANK during the swing phase, which causes the front part of the rigid plantar plate to touch the supporting surface. To eliminate this, there is a need for excessive lifting on the other leg during its support phase, which leads to a sharp increase in the patient’s energy expenditure, overload of the second limb, and an unnatural walking pattern. The inconsistency in the location of the axes also contributes to the occurrence of piston movements between the limb segments and the links of the OANK.

The technical objective of the present invention is to increase motor functions when walking in a patient wearing an orthopedic apparatus of the lower limb (LOA) with the consequences of spastic, flaccid paralysis, paresis of the lower extremities, accompanied by pathological conditions, contractures in the joints, decreased motor functions, optimization of biomechanical characteristics in the emerging biotechnical system ( BTS) “OANK-lower limb”, such as the mass-inertial characteristics of the links, the components of the moments of external forces due to the recovery of energy by elastic elements in the hip, knee and ankle joints and the metatarsophalangeal and interphalangeal sections of the foot link, the exclusion of immobilization in the plus non-phalangeal and interphalangeal joints of the foot, maintaining the alignment of the knee joint and the knee joint, eliminating piston movements of the limb in the OANK, optimizing the construction scheme, which helps improve motor functions and thereby increase the level of rehabilitation, mobility, activity in everyday life, reducing disability, severe limitations in life.

The set technical objectives are achieved due to the fact that plaster negatives are first (first) made, and from them plaster positives of the thigh and lower leg segments with the foot of the patient’s lower limb are made, their centers of mass are determined in the projection onto the sagittal plane, the OANC is made with an electrical stimulator and cutaneous electrodes, electric drives of hinge units, determine the centers of mass of the links of the thigh and lower leg with the foot OANK, combine them with the centers of mass of plaster casts of the thigh and lower leg with the foot, respectively, manufacture a simulating device of the lower limb, which has adjustable weight and length parameters of the lower limb, hip, knee, ankle axis, set the centers of mass of the links of the thigh and lower leg with the foot of the device in accordance with the centers of mass of the plaster positive segments of the thigh and lower leg with the foot of the patient, determine the frequency of natural oscillations of the links of the simulating device of the lower limb, adjust the position of the link of the lower leg with the foot, determine the frequency of natural oscillations link of the lower limb with the foot, install the manufactured OANK on the simulating device of the lower limb, determine the natural frequency of the lower limb link with the foot of the simulating device of the lower limb with the link of the lower leg with the foot OANK, adjust the position of the center of mass of the link of the lower leg with the foot OANK, changing the location of the masses of parts and assemblies in the lower leg link and the foot link, the knee hinge unit, moving the installation site of the drives, bringing the frequency of natural vibrations of the leg and thigh joint of the BTS closer to the frequency characteristic of the arbitrary walking pace of a sick average person with similar medical indications and anthropometric data, determine the degree of pathological damage to the muscles of the lower limb and are selected depending on the degree of damage, in proportion to the degree of damage, the stiffness of the front and rear hip, knee and ankle elastic elements, then the rear and front adjustable ankle stops with rear and front counter-supports are installed on the lower leg and foot links, the rear automatic adjustable knee stop is installed on the lower leg link stop and connect it to the control system, and on the hip link at the back a counter-support of the hip link is installed, while consoles are installed in front on the lower leg and thigh links, and a rear adjustable hip support is placed in the upper part of the hip link at the back, and on the back surface of the torso fastening link a rear torso support, while an adjustable support is installed on the front surface of the thigh link, and on the fastening link on the body there is a front torso support, then elastic elements are made and installed on the rear and front adjustable ankle supports, on the rear automatic folding adjustable knee support, on console, on the rear adjustable femoral support and an adjustable support in accordance with the previously determined rigidities, a plantar plate is made of a composite material that is rigid in the heel region, arch-shaped in the central part and elastically flexible in the form of plates in the area plus the non-phalangeal and interphalangeal areas, a knee hinge is made a unit with a polycentric axis of rotation in the form of a cycloid, the initial instantaneous point of rotation of which is spaced from the instantaneous point of rotation at a flexion angle in the knee joint of 60 degrees by at least 10 mm, while the center of the axis of the hip joint is aligned with the center of the axis of the hip joint , the instantaneous center of rotation of the axis of the polycentric knee joint joints in a straightened position as far as possible is combined with the conditional center of the axis of the knee joint in a straightened state, and the centers of the axes of the ankle joint joints are combined with the centers of the axis of the ankle joint.

The presence of distinctive essential features allows us to conclude that the invention meets the patentability criterion of “novelty”.

The claimed technical solution is not obvious to a specialist, which allows one to draw a conclusion that the claimed invention meets the “inventive step” criterion.

The claimed invention can be made from known materials using known means, which allows us to conclude that the claimed invention meets the criterion of “industrial applicability”.

In fig. Figure 1 shows schematically the definition of the center of mass of the plaster positive of the lower leg with the foot C _g and its distance from the axis of the knee joint L. In Fig. 1 plaster positive of the lower leg pos. 1 lies at one end on the base, pos., which can be moved along the cast. 2, having a stop pos. 3, and others on the scales, pos. 4. Scales and base are located on the table pos. 5. For the plaster positive of the hip - similarly.

In fig. Figure 2 shows a diagram of a lower limb simulator in the frontal plane, which consists of a telescopic simulator of the hip segment, pos. 6, which allows you to set different lengths depending on the parameters of the patient, in the upper part of which the sleeve pos. 7 with a long hip axis pos. 8, installed at the ends in support bushings pos. 9. In the lower part, the telescopic simulator of the thigh segment is hingedly connected by the knee axis pos. 10 with a telescopic simulator of the lower leg segment pos. 11. Its lower end is hinged at the ankle axis, pos. 12 with artificial foot pos. 13. On the telescopic simulators of the leg and thigh segments, sets of disk weights pos. 14 and pos. 15 with the possibility of changing them and moving along the segments with subsequent fixation.

In fig. Figure 3 shows a diagram of a simulation device of the lower limb in the frontal plane in the process of determining the frequency of natural vibrations of the lower leg and foot links. In addition to positions similar to those in figure 2, a position has been added. 16 - rod at one end connected to a telescopic simulator of the thigh segment, to the other end of which force P is applied through a dynamometer pos. 17. In this case, the telescopic simulator of the thigh segments deviates relative to the vertical by an angle α, and the lower leg segment deviates relative to the telescopic simulator of the thigh segment by an angle [3. The lower limb simulator is supplemented with a stopwatch pos. 18.

In fig. Figure 4 shows a diagram of a lower limb simulator with an orthopedic device installed on the lower limb (LOAD). In addition to positions similar to those in FIG. 2 added positions indicating the thigh sleeve pos. 19, shin sleeve pos. 20, foot sleeve pos. 21, with fastenings pos. 22. Bushing of the hip joint OANK pos. 23 is installed on this hip axis pos. 8 on one side of the bushing pos. 7 depending on the OANK on the right or left leg, and the bushings of the knee and ankle joints of the OANK are installed on the knee and ankle axes pos. 10 and pos. 12 respectively.

In fig. Figure 5 shows a diagram of a lower limb simulation device in the sagittal plane with an installed OANK in the process of determining the frequency of natural oscillations with positions similar to those in Fig. 4 and adding traction pos. 24 with one end connected to the telescopic simulator of the thigh sleeve, pos. 6, at the other end of which there is a dynamometer pos. 25 and force P is applied, and the existing stopwatch is used, pos. 18.

In fig. Figure 6 shows a diagram of the biomechanical system “OALC-lower limb” (LLC) with elastic elements in the forward push phase during locomotion in the sagittal plane. BTS consists of: link moans poses. 26, lower leg link pos. 27, hip link pos. 28, torso links with attachment to the torso, pos. 29. On the front part of the foot link there is an elastic element such as a spring, pos. 30, at the bottom of the foot link, on its plantar surface, an elastic spring-type element with spring-type plates is installed in the area of the metatarsophalangeal joint and the interphalangeal section, pos. 30. On the upper edge of the foot link, the front is equipped with a front adjustable stop with a front ankle elastic element pos. 31, and the front leg link is equipped with a front counter support pos. 32, the rear foot link is equipped with a rear adjustable stop with a rear ankle elastic element pos. 33, and the shin link on the rear surface is made with a rear counter support pos. 34.

In this case, in the middle part of the shin link in front there is a console with a front knee elastic element pos. 35 the upper end, which is installed on the thigh console pos. 36, which is installed in front in the middle area of the hip link pos. 28.

An automatic adjustable knee support is installed on the back surface of the shin link in the upper part, connected to the control system and having a rear knee elastic element pos. 37 in contact with the rear counter support of the thigh link, pos. 38. An adjustable hip support with a front hip elastic element pos. 39, and the fastening link on the body at the front is equipped with a front body support pos. 40. On the back surface of the thigh link at the top there is a rear adjustable hip support with a rear hip elastic element pos. 41, and on the rear torso fastening link there is a rear torso support pos. 42. In the front part of the foot there is a metatarsophalangeal joint that passes into the interphalangeal joint - MCP. The foot link is connected to the shin link through the ankle joint - GSS, and the shin link is connected to the thigh link through the knee joint - KS. The thigh link is connected to the torso link, which is attached to the body through the hip joint - TBS. The BTS functions due to the action of moments of force in the metatarsophalangeal joint - Mp, the ankle joint - Mg, the knee joint - Mk and the hip joint - Mt. When moving in different phases of a step, an angle α is formed between the supporting surface and the plantar surface of the foot link, an angle β is formed between the foot link and the lower leg link, an angle γ is formed between the lower leg link and the thigh link (in this position of the BTS, angle γ = 0) between the torso link and the hip link - angle Δ. The angle of deviation of the torso link from the vertical ψ has insignificant values (amplitude less than 3°) and therefore it is conventionally accepted that ψ = 0. In the torso link with attachment to the torso, the general center of mass of the GCM is conventionally shown moving in the sagittal plane along a sinusoid.

In fig. Figure 7 shows a BTS with elastic elements in the bending phase in the knee joint during the support period. The designations and reference numbers are the same as those shown in FIG. 6.

In fig. Figure 8 shows the BTS with elastic elements in the full support phase in the area of maximum lift of the GCM. The designations and reference numbers are the same as those shown in FIG. 6

In fig. Figure 9 shows a BTS with elastic elements in the rear push phase. The designations and reference numbers are the same as those shown in FIG. 6.

Figure 10 shows a BTS with elastic elements in the middle of the limb transfer period. The designations and reference numbers are the same as those shown in FIG. 6. Here, an automatic folding adjustable knee support with an elastic element is presented in an unlocked, rotated state to provide a flexion angle at the knee joint of more than 20°.

In fig. 11 shows a diagram of the movement of the leg segment relative to the thigh segment, which shows the femur, pos. 43 tibia pos. 44 and the proposed trajectory of movement of the centers of rotation of the polycentric and knee joint assembly, pos. 45.

In fig. Figure 12 shows diagrams of the relative positions of the BTS links when the axes of the hinge nodes of the OANK do not coincide with the axes of the joints of the lower limb in different phases of the step.

a) front push phase;

b) rear push phase;

c) transfer phase.

In fig. 13 shows the testing of the method.

The claimed method can be carried out as follows. After diagnosing and determining the indications for use and taking measurements, plaster negatives are removed from the segments of the lower extremity of the thigh and lower leg with the patient’s foot, and then plaster positives of the thigh and lower leg with the foot are made from them. It is then determined as shown in FIG. 1, center of mass of gypsum positives pos. 1. After this, the OANK is manufactured, installing on it, taking into account medical indications, an electrical stimulator with cutaneous electrodes, and in the hinge units of the OANK, drives with a control system are installed in accordance with medical indications and the OANK is supplied with an external source of energy.

Thereafter, the lower limb simulator device of FIG. 2, installing it with the help of telescopic links of the thigh pos. 6 and shins ace. 11 distance between the axis of the hip hinge unit pos. 8 and the axis of the knee joint, pos. 10 equal to the length of the plaster positive of the thigh, and the distance from the axis of the knee joint to the lower limb of the foot link, pos. 13 in accordance with the size of the plaster cast of the lower leg with the foot, pos. 1. Then, using the selection and movement of adjusting weights pos. 14 and pos. 15 install them so that the centers of mass of the hip links are aligned, pos. 6 and shins pos. 11 with foot pos. 13 with the centers of mass measured from plaster casts of the femur and tibia with the foot, respectively. By applying fig. 3 by means of traction pos. 16 and dynamometer pos. 17 force P to the hip link pos. 6 with a speed V equal to the average static speed of movement of the thigh segments in people with anthropometric data close to the patient’s data, at an arbitrary walking pace, when, as is known, energy expenditure is minimal. This makes it possible to use the potential of the OANC to a greater extent to increase its motor functionality without increasing the power of the drives, the capacity of the batteries, leading to an increase in their mass, dimensions, without increasing the intensity of electrical stimulation, which negatively affects the patient’s cardiovascular system.

By comparing the obtained values of the frequency of natural vibrations with the average statistical frequencies of people with similar anthropometric data at an arbitrary walking pace, a discrepancy is revealed.

After finding the resulting natural vibration frequency of the lower leg link, pos. 11 with foot pos. 13, a custom made for a given patient is installed on a lower limb simulator. O APC FIG. 4 by first removing the axes of the hinge joints from it, combining them and replacing them with the axes of the hip position. 8, knee position. 10 and ankle position. 12 lower limb simulator nodes. Then the frequency of natural vibrations of the lower leg link is determined, pos. 11 with foot pos. 13 in the same way as was done for the links of the lower limb simulator device FIG. 2 without OANK. Naturally, the OANK links introduce a mismatch into the previously obtained characteristics. Therefore, the position of the center of mass of the lower leg link is adjusted, pos. 11 with foot pos. 13 due to the change, movement of mass in the lower leg links pos. 11 and pos. 20 and feet pos. 13 and pos. 22 by making them, for example, from a composite material and removing the metal load-bearing tires, they shift the installation location of the drives, carry out repeated measurements of the frequency of natural oscillations, bringing them closer to the frequency characteristic of the arbitrary walking pace of an average person with similar anthropometric data, taking into account his medical indications.

Before installing elastic elements, the degree of pathological damage to the muscles of the lower limb is determined, for example, by obtaining the electrical activity of the muscles of the lower limb during walking using electromyography. It is advisable to identify the pathological state of the muscles of both flexors and extensors, providing moments of force relative to the hip, knee, ankle, and metatarsophalangeal joints. The more significant the damage, the more rigid an elastic element is supplied to one or another joint of the hip joint, thereby replenishing lost muscle functions, alternately accumulating potential energy and ensuring movement due to its transition to kinetic in certain phases of the step.

Elastic elements are installed in the BTS in a certain way, placing them in accordance with the proposed method, as shown in Fig. 6. First, install the rear hip elastic element connected to the adjustable hip support pos. 41, which will contact the upper surface with the rear torso support pos. 42, located on a corset (semi-corset) installed on the patient’s torso for medical reasons. In front of the hip hinge unit in the upper part of the hip link, a front hip elastic element is installed on an adjustable hip support pos. 39, which automatically turns off when it is necessary to sit in an orthopedic device when the angle in the hip joint is 80-110 degrees. Elastic elements pos. 39 and pos. 41 in various phases of the step are in contact with the counter supports pos. 42 and pos. 40.

In the knee joint, the rear knee elastic element is pos. 37 is installed on an automatic adjustable knee rest, located on the back surface of the shin link, pos. 38. This stop automatically stops preventing flexion at the knee joint during the transfer period when the knee joint is bent more than 20 degrees. Another elastic element is placed in front of the knee joint, connecting it at one end to the console, pos. 35, placed on the lower leg link pos. 27, and with the other end placing pos. 36, placed on the hip link pos. 28. Moreover, on the front of the knee joint there is a guide in contact with this elastic element, along which it slides during the transfer period. Two elastic elements pos. 31 and pos. 33 is installed on supports, one in front and one behind the ankle joint, which are in contact with the counter supports and pos. 32 and pos. 34. More elastic elements of the spring type, pos. 30 in the form of elastic-flexible plates is installed on the plantar part of the foot link, pos. 26 rigidly covering the heel area with a transition in the middle area into an arched elastic part, ending in front in the area of the metatarsophalangeal and interphalangeal joint with spring-type plates. These spring-type elastic elements pos. 30 are made individually from a composite material based on carbon fiber and Rusar fabric, so that the spreading of the arched section during the support phase of the entire foot does not occur completely under the weight of the given patient, and a gap of at least 3 remains between the lower surface of the plate and the supporting surface along the center line mm. At the same time, in the phase of the rear push when bending, the front spring-type plates pos. 30 provide bending in the interphalangeal area and metatarsophalangeal joint up to 25-30°, providing a moment of force of at least 50 Nm in accordance with individual anthropometric characteristics and medical and biomechanical indications.

The elastic elements in the hip, knee and ankle joints are graded, multi-colored, adjustable in rigidity and size, they work for compression, except for the front knee elastic element pos. 35, working in tension.

The elastic elements installed in accordance with the proposed method operate in the main phases and periods of the BTS step, shown in Fig. 6÷10, as follows.

The support period begins with the forward push phase, as shown in Fig. 6. This phase is characterized by the beginning of an increase in the vertical component of the ground reaction vector, a minimum position of the GMC, maximum flexion at the hip joint and, consequently, maximum extension of the limb forward, as well as the need to ensure stability in the knee joint and reduce the impact load. The gluteus maximus, quadriceps femoris and tibialis anterior muscles work most actively during this phase. When the heel comes into contact with the supporting surface, the plantar surface of the foot link pos. 26 is at an angle α to it, the lower leg link is pos. 27 - at an angle β to the foot. Shin links pos. 27 and hips pos. 28 are located on the same straight line, the knee joint is straightened. Hip link pos. 28 is bent at an angle Δ at the hip joint relative to the vertical. Elastic elements in this phase function as follows, providing additional moments of force in the joints and influencing movements in conjunction with muscles weakened due to lesions. Rear ankle elastic element pos. 33 is compressed, taking on the shock load when placing the limb on the supporting surface, accumulating potential energy and ensuring the creation of a moment of force M _g for extension, while the front ankle elastic element is pos. 31 is in its original unloaded state. Rear knee elastic element pos. 37 is designed in such a way that it is compressed by 15-20% of the maximum compression, which provides resistance to sudden bending that can occur in the first moments (0-5%) of the step time and its functionality is insurance against loss of buckling stability. Front knee elastic element pos. 35 is in the initial unloaded state, just like the rear hip elastic element. At the same time, the anterior hip elastic element pos. 39 is in a compressed state and, perceiving the load, creates a moment of force _Mt , aimed at extending the hip link pos. 28, which is consistent with the moment of residual internal muscle forces of the limb. Thus, the rear knee elastic element located in a similar way is pos. 37 provides functional support for hip extension movements and prevents sharp buckling of the knee joint. Plantar element with toe elastic element pos. 30 is in its original unloaded state.

In the bending phase of Fig. 7, the position of the GCM decreases to the maximum value, while a maximum of the vector of the vertical component of the support reaction is noted, which exceeds the mass of the BTS. The BTS seems to crouch a little from the impact and here it is also necessary to supplement the weakened functions of the musculoskeletal system. The elastic elements arranged according to the proposed method function during this phase as follows. Front and rear ankle elastic elements pos. 31 and pos. 33 are in a pre-stressed state, creating alternately opposite directions of the moment of force M _g , thus holding the lower leg pos. 27 in a stable spring-loaded position. Rear knee elastic element pos. 37 is compressed to the maximum, providing a reserve of potential energy obtained under the influence of the mass of the overlying links. Front knee elastic element pos. 35 does not affect the moment of forces _Mk , because It begins to stretch only when the angle of the knee joint is greater than 20°. Rear hip elastic element pos. 41 is in an unloaded state and does not affect _Mt , unlike the anterior hip elastic element pos. 39, which is compressed and creates an additional moment of force for extension in the hip joint, providing an increase in the functionality of the hip joint, which has insufficient muscle capabilities. Plantar element with toe elastic element pos. 30 in this phase spreads out without affecting the toe part, due to which, in accordance with the proposed method, shock absorption is provided from the maximum load on the foot. 26.

Another position of the BTS with elastic elements is shown in Fig. 8 and it characterizes the support phase of the entire foot of the support period before the start of the rear push phase. This phase is characterized by the vertical component of the ground reaction being close to the second maximum, the GCM being slightly above the average value, and the work mainly of the gastrocnemius muscle. The knee joint is straightened, the ankle joint is flexed, and the hip joint is extended, preparing for the rear push by several degrees. In this case, the elastic elements function as follows. Front ankle elastic element pos. 31 is somewhat compressed, acting on the moment of force Mg, while the rear ankle elastic element pos. 33 is in its original unloaded state. Rear knee elastic element pos. 37 is also in the initial somewhat spring-loaded state, and the front knee elastic element is pos. 35 in neutral. Rear hip elastic element pos. 41 begins compression due to extension in the hip joint, while the anterior hip elastic element pos. 39 - in neutral state. The middle part of the elastic element of the plantar part, pos. 30 foot links pos. 26 during this phase is flattened, and the front part in the area of the metatarsophalangeal and interphalangeal areas, representing the spring plates, bends slightly.

The functioning of the elastic elements in the rear push phase is shown in Fig. 9. In this phase, the greatest extension angle is achieved in the hip joint, while the rear hip elastic element is pos. 41 is compressed to the maximum amount, subsequently providing a moment of force Mt for extension and subsequent flexion, while the anterior hip elastic element pos. 39 is in neutral state. Rear knee elastic element pos. 37 is slightly tucked in, and the front knee elastic element is pos. 35 in neutral position. The greatest compression is experienced by the rear ankle elastic element pos. 33, as well as spring plates of the metatarsophalangeal and interphalangeal sections, pos. 30, creating the maximum possible moments of forces M _p and M _g ensuring repulsion from the supporting surface and forward movement of the entire BTS.

In the next phase - transfer of the limb (Fig. 10) the hip link nos. 28, brought forward and bent at the hip joint, including due to the action of the rear hip elastic element pos. 41 presses the front hip elastic element pos. 39, which primarily inhibits excessive flexion of the hip joint, pos. 28, and in the second it creates a moment of force for extension in the hip joint. Rear knee elastic element pos. 37, due to the operation of the automatic lock, does not prevent bending in the joint at an angle γ. Front knee elastic element pos. 35 is stretched, and creates a moment of force Mk aimed at extension in the KS. Ankle elastic elements pos. 31 and pos. 33 are in a preset somewhat compressed state. An embodiment is possible in which the moment of force due to the ankle rear elastic element pos. 33 slightly raises the toe part of the foot link pos. 26 for more comfortable transfer over the surface. Position of the plantar elastic element pos. 30 is neutral.

Carrying out movement in the knee joint is the most difficult, which is presented in the form of successive positions of the articular end of the tibia. 44 relative to the femur pos. 43, as shown in FIG. 11. The movement occurs around a curve that moves depending on the angle of flexion, formed by the instantaneous centers of rotation of the complex shape of the poses. 45 similar to a cycloid. The structure of the knee joint ensures shortening of the lower limb during the swing period and displacement of the tibia, which helps ensure stability. Providing, in accordance with the BTS method, a polycentric knee joint with a trajectory of the center of rotation in the form of a cycloid shown in Fig. 11 increases motor functions by reducing the length of the limb during the swing, as well as increasing the rigidity of the posterior knee elastic element in the bending phase by reducing the distance between the hip links. 28 and shins pos. 27. In this case, in a polycentric knee joint, the initial instantaneous point of the cycloid is removed from the instantaneous point at a flexion angle of 60 degrees of the tibia link relative to the thigh link by at least 10 mm.

The claimed method, in terms of the location of the axes of the hinge joints, can be determined as follows. The location of the center of the axis of the hip, knee, and ankle joints is determined in projection onto the sagittal plane, which can be done by an orthopedic doctor by palpation after tilting the torso or using an x-ray in the sagittal plane, marking the center of the axis of the hip joint using a plumb line or a laser vertical line, combine with the vertical center of the knee and ankle joints and mark them on the patient’s body, for example, with a special pencil. During the process of removing the plaster negative and then making the positive, the center marks from the vertical line are reflected on their surfaces and then marked on the sleeves. When installing hinge units, the centers of rotation of their axes are set in accordance with the marks. In the event of a discrepancy between the installation locations of the axes of the hinge units and the axes of the joints of the lower limb, an imbalance in the movements of the OANK links and limb segments occurs, as is shown, roughly schematically, in Fig. 12, in the phases of the front push, rear push, and also during the period of transfer (a, b, c).

Below is an example of the method.

The proposed method of increasing motor functions when walking in an orthopedic device was used to treat patient L, age 34 years, height 165 cm. Diagnosis: paresis of the muscles of the right lower limb due to flaccid paralysis. Previously, patient L-va used a OANK with drives, an external energy source and an electrical stimulator, and electrical stimulation was carried out in a limited manner due to concomitant diseases. Some biomechanical characteristics of gait in this OANC were recorded. Then the organization of patient L was carried out according to the proposed method. The patient had plaster negatives made, and from them plaster positives of the segments of the torso, thigh, lower leg and foot were made. Then, using a base with a stop and weights, the centers of mass of the positives of the lower leg with the foot of Fig. 1 and hips. Using ready-made plaster positives, foot sockets were made for poses. 21 (Fig. 4) with built-in spring-type elastic elements pos. 30 (Fig. 6), shins, thighs and half-corset, a hip joint assembly is installed, knee polycentric, with an axis of rotation, describing a curve in the form of a cycloid of poses. 45 (Fig. 11), hinge joints and ankle joints. Moreover, in the projection onto the sagittal plane, the axes of the hinge joints were placed so that they coincided with the axes of the corresponding joints in the vertical position of the leg (along the so-called Mi Kulich line). On all sleeves, adjustable stops were installed in the area of the hinge joints. Moreover, the rear knee support pos. 37 was performed automatically controlled depending on the load on the foot, and the front hip support pos. 39 had a handle, by turning which the patient could bend her leg at the hip joint to sit. The assembled OANK was equipped with electric drives with a control system and an external energy source.

On the manufactured lower limb simulator device FIG. 2, the weight and length of note parameters were set identical to those of the patient L-oh and applying poses to the pull-up. 16 (Fig. 3) the force was determined by the frequency of natural vibrations of the lower leg link pos. 11 with foot pos. 13, adjusting them to the optimal value characteristic of an arbitrary walking pace.

Then the OANK was installed on the simulator device of the lower limb and the frequency of natural oscillations of the lower leg link was again determined. 11 with foot pos. 13. To obtain optimal values in the OANK, the foot sleeve pos. 21 (Fig. 4), in which metal tires were replaced with lightweight composite ones, due to which the frequency of natural vibrations of the lower leg link pos. 11 with foot pos. 13 approached the frequency at an arbitrary walking pace.

Then, in patient L, the electrical activity of the muscles of the right lower limb was determined using electromyography. The identified insufficient activity with reduced amplitude served to select the rigidity of the elastic elements. After fabrication and installation of the anterior and posterior ankle positions. 31 and pos. 33 and hip poses. 39 and pos. 41 elastic elements, as well as rear and front knee elastic elements pos. 35 and pos. 37, patient L was taught to walk. Then the patient walked independently as shown in Fig. 13.

During walking, parameters characterizing motor functions were determined. There was an increase in step length, both on the orthotic and healthy limbs, and walking tempo by 12±5%, approaching the voluntary pace characteristic of a person with similar weight-dimensional characteristics in normal conditions, and rhythmicity improved.

It became much easier for the patient in the OANK manufactured in accordance with the proposed method to carry out the limb links, and the depreciation during the forward push phase improved. A smoother bending of the knee joint during the period of support and an additional effect of the posterior knee elastic element were noted. 37 in this phase during extension, which made it possible to raise the torso slightly higher than when walking on the previously used OANK. The patient felt a more “energetic” extension of the affected limb in the hip joint and an increase in the rhythm of both flexion and extension in the knee joint. When walking, the patient felt movements of the fingers in the foot of the affected limb, which was not previously the case in the old OANK. A decrease in the charge consumption of an external energy source was revealed, which made it possible to install a battery of smaller weight and dimensions. A selection of drives with smaller dimensions and weight was made, since their power was determined to be excessive in combination with the use of a rational mass of the lower leg link pos. 27, a system of elastic elements, provision of movements in the MCP joint, polycentricity of the knee joint and rational location of the hinge axes in relation to the axes of the joints. The patient noted the absence of piston movements of the leg relative to the sleeves of the device during walking.

External examination after removal of the OANK showed the absence of abrasions and swellings observed when walking in the previously used OANK, as well as improved blood circulation in the fingers of the affected limb. After examination, the orthopedist gave a positive assessment of the effect of OANK and recommended further use for 6 months. A follow-up examination of the patient after 5.5 months confirmed an improvement in her condition compared to the condition before the use of the new OANK in accordance with the proposed method. There was an improvement in statokinetic stability, normalization of the walking pattern, and less fatigue when walking. The orthopedic surgeon positively assessed the use of the new OANK and recommended wearing it in the future.

Examples of testing have shown the effectiveness of the proposed method of increasing motor functions when walking in the OANK. Based on practical use, recommendations were issued to reduce weight, power dimensions of tank drives, and battery dimensions.

The proposed method of increasing motor functions when a patient walks in the OANK, ensuring during the walking process the rational mass-inertial characteristics of the OANK links in combination with the changed mass-inertial characteristics of the limb segments, the functioning of the foot links built into the area, the ankle, knee, hip hinge nodes of the system of elastic elements , the use of a knee hinge unit with a polycentric axis of rotation in the form of a specific cycloid, a certain location of the axes of the hinge units in relation to the axes of the joints ensures the normalization of the biomechanical characteristics of patients' walking, increasing their activity in everyday life, reducing fatigue, energy consumption, and bringing the walking pattern closer to normal.

After orthosis using the proposed method, motor functions of walking increased, disability rates decreased, and the level of adaptation increased.

Thus, the advantages of the proposed invention “Method of manufacturing an orthopedic apparatus of the lower limb for patients with consequences of paralysis of the lower limbs” in comparison with the prototype are the following:

- determination and implementation of rational mass-inertial characteristics of the OANK links, which makes it possible to normalize the frequency of natural oscillations when walking and bring the walking pace to an arbitrary, least energy-intensive one;

- obtaining energy recovery through the use of a system of elastic elements built into the OANK structure;

- use of a polycentric knee joint with a specific trajectory of instantaneous centers of rotation;

- a certain location of the axes of the hinge joints, coinciding with the location of the axes of the corresponding joints in the projection onto the sagittal plane;

- ensuring movements in the metatarsophalangeal and interphalangeal joints in the foot of the affected limb;

- normalization of biomechanical characteristics of walking, reduction of fatigue, energy consumption when walking in patients;

- obtaining a socio-economic effect by reducing pronounced limitations in life, improving the quality of life, the degree of self-care, increasing efficiency and reducing rehabilitation time, which will reduce budget costs.

Information sources:

1. Patent: A method for strengthening the muscles of the affected limb and an orthopedic device for its implementation.

http://www.freepatent.ru\patents\2088273

1. Exoskeleton with electrical stimulation while walking

https://ok.ru/video/1895722257037

Claims (1)

A method for manufacturing an orthopedic apparatus of the lower extremity for patients with the consequences of paralysis of the lower extremities, which consists in manufacturing, in accordance with medical indications, an orthopedic apparatus of the lower extremity (LOAN) prescribed to the patient, containing a link for its attachment to the body, a hip link, connected by a hip joint to the axis, a link shin, connected to the thigh link by knee joints with an axis, ankle joints with an axis, connected at the top to the shin sleeves, and the bottom - to the foot link, which has a rigid plantar plate, including the metatarsophalangeal and interphalangeal sections, an electrical stimulator with a power source and cutaneous electrodes installed in the area of one of the joints, as well as electric drives of hinge units with axes with a control system and an external energy source, characterized in that plaster negatives are first made, and from them plaster positives of the thigh and lower leg segments with the foot of the patient’s lower limb are determined in projections onto the sagittal plane of their centers of mass, make the OANK with an electrical stimulator and skin electrodes, electric drives of the hinge units, determine the centers of mass of the links of the femur and lower leg with the foot of the OANK, combine them with the centers of mass of plaster casts of the thigh and lower leg with the foot, respectively, make an imitation device of the lower limb, having adjustable weight and length parameters of the lower limb, hip, knee, ankle axes, set the centers of mass of the thigh and lower leg links with the foot of the device in accordance with the centers of mass of the plaster positive segments of the thigh and lower leg with the patient’s foot, determine the frequency of natural oscillations of the imitation links devices of the lower limb, adjust the position of the lower limb link with the foot, determine the frequency of natural vibrations of the lower limb link with the foot, install the manufactured OANK on the imitation device of the lower limb, determine the frequency of natural oscillations of the lower limb link with the foot of the simulating device of the lower limb with the lower limb link with the foot OANK, adjust the position center of mass of the lower leg link with the foot OANK, changing the location of the masses of parts and assemblies in the lower leg link and the foot link, the knee joint unit, moving the installation site of the drives, bringing the frequency of natural vibrations of the lower leg and thigh joint of the BTS closer to the frequency characteristic of the arbitrary walking pace of a sick average person with similar medical indications and anthropometric data, determine the degree of pathological damage to the muscles of the lower limb and select depending on the degree of damage, in proportion to the degree of damage, the rigidity of the anterior and posterior hip, knee and ankle elastic elements, then install rear and anterior adjustable ankle stops on the lower leg and foot links with rear and front counter-supports, a rear automatic adjustable knee support is installed on the shin link and connects it to the control system, and a counter-support of the thigh link is installed on the thigh link at the rear, while consoles are installed in front on the shin and thigh links, and in the upper part of the thigh link at the back is placed rear adjustable thigh support, wherein a rear torso support is installed on the rear surface of the torso attachment link, while an adjustable support is installed on the front surface of the thigh link, and there is a front torso support on the torso attachment link, then elastic elements are made and installed on the rear and front adjustable ankle supports, on the rear automatic adjustable knee support, on the console, on the rear adjustable thigh support and an adjustable support in accordance with previously determined rigidities, the plantar plate is made of a composite material rigid in the heel region, arched in the central part and elastically flexible in the form of plates in areas of the metatarsophalangeal and interphalangeal sections, a knee joint is made with a polycentric axis of rotation in the form of a cycloid, the initial instantaneous point of rotation of which is separated from the instantaneous point of rotation at a flexion angle in the knee joint of 60 degrees by at least 10 mm, while the center of the axis of the hip joint the node is combined with the center of the hip joint axis, the instantaneous center of rotation of the axis of the polycentric knee joint joints in a straightened position is combined with the conditional center of the knee joint axis in a straightened state, and the centers of the axes of the ankle joint joints are combined with the centers of the ankle joint axis.