RU2647608C1 - Orthosis on an ankle joint and foot - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to orthotics. Orthosis on the ankle and foot for people with neurological pathologies of central and peripheral genesis contains a molded plastic case of feet holder (1), designed to be placed in shoes for everyday wearing and having belts that are capable of fixing in the region of shin and ankle (10), a "toe" and the tension system – between the "toe" and the feet holder. Base of the tensioning system is made of capron thread (7), with regulator (8) of its length, which fixes the "toe" behind thimble (6) to carabiner (11), which is regulated in the horizontal plane by loops (12) located on the additional strap (3) of the feet holder. "Toe" is a rigid hollow body, made with the possibility of putting on the toe of shoes and fastening in the sole part directly to shoe (9, 14). Inner surface of the "toe" repeats the shape of the shoe toe contacting part and is made with the possibility of a tight fit to it.

EFFECT: technical effect: optimizing the dimensions of the orthosis and the weight of the structure; increased wearing comfort; reduction in the number of components and, as a consequence, ensuring the possibility of an acceptable price policy of the product.

6 cl, 2 tbl, 7 dwg

Description

The invention relates to the field of medicine, specifically to orthosis. The developed three-component orthosis is designed for functional adaptation of the ankle and foot of people with neurological pathologies of central and peripheral origin. With a decrease in the strength of the dorsal flexion of the foot and (or) pronounced spasticity of plantar flexion (more than 3 points on the Ashworth scale), wearing an orthosis not only reduces spasticity, which in turn prevents the occurrence of myofascial contractures, but also helps to improve the physiological stability of the limb, the formation of the correct stereotype of walking and a decrease in the risk of falling, which reduces psycho-emotional stress, allowing a person to train the stereotype of walking everyday in his usual shoes, in any conditions, any surface at any level of activity.

The use of the developed orthosis can be effective in traumatology, orthopedics, surgery, sports medicine, neurology in the process of rehabilitation after a stroke.

To date, of the stop holders, made at the modern level of technology and technology, the following analogues are known:

1. Analogue No. 1 (RF patent 2320299, published 03/27/2008)

The disadvantages of the technical solution of this stopper are:

• Thickening in the ankle area due to the mechanisms of correction of the position of the foot creates a three-dimensional structure; also, due to the presence of high lateral fixators of the foot, the opportunity to wear non-specialized shoes is lost.

• Full fixation of foot movements, reducing the level of wearing comfort, leads to limited mobility in walking.

• The tangible weight of the structure when wearing this orthosis.

• High pricing policy, determined by the high cost of components.

2. Analogue No. 2 (RF patent 2140230, published on 10.27.1999)

The disadvantages of the technical solution of this analogue are:

• The presence of a large number of fixation elements on the human body reduces ease of use and creates bulkiness.

• The tangible weight of the structure when worn.

• The emergence of new, lighter materials with high strength characteristics makes it appropriate to replace this model in order to increase mobility and convenience.

3. The closest to the claimed technical solution - its prototype - today is an orthosis on the ankle joint and foot AFO-101 made in Germany (company Rehard Technologies GmbH).

Despite the advantages over the analogs given above, the prototype of this development has its drawbacks:

• Inability to form sufficient dorsal inflection with a high level of spasticity (on the Ashworth scale above 3 points, table 1).

Disclosure of the invention:

• The invention relates to medicine, specifically to orthosis. The developed three-component orthosis is designed for functional adaptation of the ankle and foot of people with neurological pathologies of central and peripheral origin.

• The orthosis consists of:

plastic frame - the first component of the orthosis - (1); "Cape" - the second component of the orthosis - (2); retainer straps (3); metal-plastic fasteners of the fixation belt of the lower leg (4); self-adhesive Velcro (5); thimble for fixing to a carbine (6); kapron filament - the basis of the third component - (7); a length regulator for kapron filaments (8); “Toe” with holes (9) in the case of fastening the “toe” with fixing drills and the drill itself (9); fixation straps of the lower leg and ankle joint (10); carbine (11); loops of horizontal fixation of a carbine (12); a strap for fixing the “toe” to the shoe through the heel (13); “Toe” with holes (14) in case of fastening the “toe” by hemming.

The development objectives of the proposed orthosis - optimization of the dimensions of the orthosis and weight of the structure; increase wearing comfort; reducing the number of components and, as a result, ensuring the possibility of an acceptable pricing policy for the product.

Comparative characteristics. The molded plastic case of the stopper - the first component of the orthosis - is inserted into ordinary shoes for everyday wear. The case has a strap-clamp with a carabiner, which is adjustable in the horizontal plane using loops. The locking strap fixes the second component of the orthosis, the “toe”, fastened with the help of the third component - the tension system made of nylon, behind the throat. "Toe" is a rigid hollow body, worn on a toe of shoes. The inner surface of the “toe” repeats the shape of the contacted part of the toe of the shoe and fits snugly to it. “The toe” serves as an additional stabilizer of the foot. Together, all three components increase the strength of the orthosis and improve the support ability of the affected limb, thereby reducing the risk of falling. The “toe” is also used to protect the phalanges of the foot from the pressure created by the tension system. Fixation of the “toe” occurs directly to the shoes of a person.

When three components are working, a mechanism is formed that sets the level of dorsal flexion and restricts plantar flexion of the foot.

The actual difference from analogues and prototype lies in the ability to set the necessary amplitude of movement of the ankle joint during training of the walking stereotype and after its formation, by adjusting the thread tension and, accordingly, the size of the dorsal flexion using the block, limiting plantar flexion.

A distinctive feature of this invention is the presence of a tension system that allows you to use the principles of closed kinematic chains, including synergists in the process of training the stereotype of walking. The second component of the orthosis, the “toe,” is the corrective link in the tension vector between the person’s shoes and the plastic sleeve.

“Mysok”, made of low-temperature thermoplastics, has the unique ability, if necessary, to be repeatedly modeled under the required shoe shape, without losing its strength characteristics.

An essential factor is the insignificant weight of the structure, which the user of the orthosis will hardly feel during classes and active household activities.

Relative ease of use - the ability to put on both components and fix them together with one hand - greatly simplifies the operation process.

When wearing an orthosis, the person adapts to a physiologically more correct walk. When fixing the heel on the supporting surface, an initial contact is formed in the depreciation phase ("RLA - Perry terminology" is used here (Fig. 7)).

The orthosis also reduces psycho-emotional stress, allowing a person to restore the stereotype of walking everyday, in his usual shoes.

Movements in the orthosis make it possible, without significant risk of falling, to train walking in any conditions, on any surface, at any level of activity.

The invention and the manufacture of elements of the orthosis are illustrated by drawings (Fig. 1 - Fig. 7), which depict:

in FIG. 1 shows a general view (side view) of a three-component orthosis;

in FIG. 2 shows the fixation of the “toe” to the shoe using a strap (side view);

in FIG. 3 shows a stopper (side view) and a device for attaching a “toe”;

in FIG. 4 shows a “toe” that is shifted from the proposed shoe to the sole, the tread of which is depicted by wavy lines. Shoes put on the heel. The structure of the third component is shown (kapron thread for fastening is shown without fixing);

FIG. 5 illustrates the method of fixing the “toe” to the shoe using hemming;

FIG. 6 illustrates the method of fixing the “toe” to the shoe using a drill.

FIG. 7 illustrates the 8 phases of the physiologically correct stereotype of walking on "J. Perry" with the highlighted first phase of "initial contact".

Making an orthosis: The first component, the “plastic frame”, consists of 60% polypropylene, 35% nylon and 5% vinyl acetate (1, Fig. 1, Fig. 3). In the shin area, a self-adhesive foam pad is attached to the inner surface to improve adhesion to the fabric and cushioning in the pressure area (5).

Two straps of hard nylon with sewn on Velcro fasten to the case.

The first belt (10, Fig. 1) on self-adhesive Velcro is fixed in the ankle joint. The belt is 30 mm wide and 80 cm long. Two soft foam paddings are used to improve traction and cushioning in the belt pressure area.

The second belt (10, Fig. 1) on metal-plastic clips (4) is mounted in the shin area. The width of the belt is 60 mm, the length is 40 cm. A softening foam pad is used in a similar way to improve traction and damping in the area of belt pressure.

The locking strap is attached with nylon threads through the holes in the plastic case (3, Fig. 1). It is made of dermatin fabric with sewn on Velcro; according to the marks, loops of nylon (12) are installed to adjust the carbine (11) made of stainless steel.

To simulate the “toe” (2) on the shoe, a workpiece is used that is close in appearance to a truncated cone and consisting (in one of the possible manufacturing options) of NTTP low-temperature thermoplastic. The workpiece is heated in hot water for about one minute, after which it is held for 5-8 minutes to adapt to the shape of the toe of the shoe. Cooling down, the NTPP turns into a solid, rigid structure that does not require, as a rule, additional reinforcement, and the presence of a “working plastic memory” gives the material the property to return to its original form when heated, which allows you to repeatedly model the product for various shoes if necessary.

The basis of the third component of the orthosis - kapron thread (7) with a thickness of 0.5-1.0 cm, the length of which is 1 meter - pierces the “toe” along the marks, passing in the area of the sole of the toe of the shoe at the level of the distal components of the metatarsal phalanges, and then, the perforated body of the “toe” , lies on the outer surface in a special cavity made in the “toe” body to protect the tension system from damage by external mechanical factors during operation. A rubberized lining (16, Fig. 4) is glued in the sole of the “toe” to improve the adhesion of the toe to the floor surface.

To fix the components of the orthosis, an aluminum thimble (6) is used, the throughput diameter of which is 2 cm, as well as a metal-plastic length regulator (8) of the nylon filament (7).

Another option for manufacturing a “toe” in the form of shoes is the use of epoxy universal glue brand EDP. Initially, according to the shape of the toe of the shoe, from 4-5 layers of dense fabric a blank is formed that is sutured along the borders of the modulated shoe; it turns out a figure similar to a truncated cone. The workpiece is immersed in an adhesive solution that completely impregnates the fabric, after which the “toe” is fixed on the shoe for 24 hours until completely cured. The edges of the “toe” are processed on a grinding machine, and according to the marks placed on the fabric, holes and recesses are drilled for threading the nylon thread and fixing the “toe” to the shoes. Hemming of the “toe” to the shoe takes place according to certain marks in the base of the product. Kapron thread allows you to fix the component for a long time, without fear of its deformation or dislocation on the shoe (14, Fig. 5).

The option of attaching the “toe” using the fixation strap by tightening the strap (13) in the foot base area through the heel is shown in Figure 2.

The most progressive is the fastening of the “toe” by means of fixation drills. The Boers pierce the sole of the shoe diagonally, attaching it to the body of the workpiece, not allowing it to shift during further operation (9, Fig. 4, Fig. 6).

Instructions for use: the order of putting on the orthosis, (Fig. 1).

Starting body position: sitting. The first component - a plastic frame (1) - is attached to the lower leg and ankle joint by fixation straps (10). The locking strap (3) is attached to the lower leg among the straps with slight sagging. After that, shoes are put on, equipped with the second component - “toe” (2). For the convenience of fastening the components, bend the leg in the knee joint at an angle greater than 90 °. This will allow you to easily pull parts of the third component - kapron thread (7) with the thimble (6) to the carbine (11), pre-adjusted in the horizontal plane by using loops (12). After fixing the thimble to the carabiner, adjustment is made with the regulator (8) - the length of the nylon thread is set, which is necessary to obtain a therapeutic effect.

The main selection of the orthosis is made according to the size of the shoe on the left or right foot.

The circumference and length of the lower leg are not important factors in the selection of the stopper, since the correction of these parameters is possible with special mechanisms located on the components of the orthosis.

Care rules for an orthosis. Wet treatment is provided at a temperature not exceeding + 40 ° С. Do not use detergents and bleaches containing chlorine. Dry away from heat and direct sunlight.

Storage conditions: the orthosis should be stored at room temperature in dry rooms, away from sources of heat, direct sunlight and dust.

Disposal conditions: Dispose of the orthosis with household waste.

An expiration date has not been established. The possibility of using an orthosis longer than prescribed by the course of treatment should be agreed with the doctor. Stopping the use of the orthosis is not allowed without the consent of the attending physician. Independent change in the design of the orthosis is not allowed. Operation of a damaged orthosis is not allowed.

Claims (6)

1. Orthosis on the ankle joint and foot for people with neurological pathologies of central and peripheral genesis, containing a molded plastic case of the stopper (1), made with the possibility of placement in shoes for everyday wear and having straps made with the possibility of fixing in the region of the lower leg and ankle joint (10), characterized in that it contains a “toe” and a tension system - between the “toe” and the stopper, while the base of the tension system is made of kapron thread (7), with a regulator (8) of its length, fixed the “toe” for the thimble (6) to the carbine (11), which is regulated in the horizontal plane by the loops (12) located on the additional strap (3) of the stopper, and the “toe” is a rigid hollow body that can be put on the toe of the shoe and fastenings in the sole part directly to the shoe (9, 14), the inner surface of the “toe” repeating the shape of the contact part of the toe of the shoe and made with a tight fit to it. 2. The orthosis according to claim 1, characterized in that the “toe” comprises a preform of low-temperature thermoplastics (NTPP) made with the possibility of fastening, after modeling, directly to human shoes. 3. The orthosis according to claim 1, characterized in that the “toe” contains a blank of fabric sewn along the borders of the simulated shoes and treated with epoxy universal adhesive of the EDP brand. 4. The orthosis according to claim 1, characterized in that it contains an additional strap attached to the base of the “toe” and made with the possibility of pulling through the heel of the “toe” and used shoes. 5. The orthosis according to claim 1, characterized in that the “toe” is made with the possibility of attaching to the shoe by means of fixation drills passing through the holes in the “toe” and the sole of the shoe, tightening the used shoes and “toe”. 6. Orthosis under item 1, characterized in that the "toe" is made with the possibility of hemming through holes in its base to the sole of the shoe.

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