DE19522687A1 - Lower limb or foot orthosis and method of manufacture - Google Patents

Abstract

The lower limb or foot orthosis (1) consists of a foot part (2) and a shaft part (3) which are made in one piece by a positive modelling technique using a plaster cast. A hard lamination is formed on the rear shaft part and on the underside of the foot part. The front of the shaft and the upper side of the foot piece are provided with a soft lamination in part. The front of the shaft part casing is locked by a series of clasps (4-7). The whole inside of the orthosis is provided with a leather cushioning layer. In the foot area there is a thick section of additional cushioning and in the shaft area there is a thinner flexible layer of cushioning.

Description

The invention relates to a lower leg and foot sleeve apparatus for use in diabetics and a process for its production.

As is well known, diabetes can lead to neuropathic disorders or microangiopathic processes Can develop diabetic foot syndrome. The symptoms of a Are diabetic foot syndrome;

• - the diabetic foot with neuropathy and infection, (neuropathic foot), characterized by the Triassic, diabetic polyneuropathy (sensitive, motor and autonomous), Injury to the foot in a typical, especially pressure-exposed area.
• - the diabetic foot with peripheral arterial occlusive disease, (ischemic-gangrene foot, macroangiopathic foot), with peripheral arterial occlusive disease (pavk), with acral or necrosis (gangrene) in the heel area, the are not initially infected.
• - The neuropathic-markoangiopathic foot, this is a combination of the above Clinical pictures.  
• - The Charkot foot, equal to diabetic bone softening with total breakdown of the arch of the foot.

The previous treatment methods for a diabetic foot syndrome are based on measures that have been used so far:
Bed rest in the acute phase for 2-4 weeks
Wheelchair about 2 weeks
Pressure relief aids such as Allgöwer, splint, Thomassplint, splint sleeve apparatus, soft foam inserts, forefoot relief shoe, bandage shoe, orthopedic shoes or walking aids such as rollators, walking frames or forearm crutches,
and, in addition to alleviating the symptoms, cannot bring about any measurable healing success.

Based on this, the present invention has the object to provide a device that is part of a Care concept to avoid or cure a diabetic foot Syndrome can be used.

To solve this problem technically, a lower leg foot Specified sleeve apparatus, consisting of a foot part and a shaft part, which are formed in one piece in positive model technology and one the rear The upper part of the shaft and the hard-laminated shell forming the sole of the foot and one each the front part of the shaft and the top of the foot are soft laminated, Divisible and closable with closure elements have all towards the foot or leg one after the other with foam padding and one Leather upholstery are provided.

Compared to conventional lower leg and foot sleeve devices, which are used in one diabetic-related diabetic foot syndrome with no relief and / or The specified combination of materials can cause healing and the manufacturing technique a lower leg and foot sleeve apparatus provided a so-called lower leg orthosis, which, like extensive  Tests have shown as part of care concepts for healing and / or can be used to prevent diabetic foot syndrome.

It is proposed with particular advantage that in the invention Lower leg and foot sleeve apparatus exclusively 100% chrome-free leather is incorporated. It is also proposed that the lower leg foot Sleeve apparatus in the soles and heels area a thick flexible padding and has thinner flexible padding in the shaft area. About that In addition, the lower leg and foot sleeve apparatus can be used in areas exposed to pressure have additional support padding. Such upholstery for areas exposed to pressure are made according to a proposal of the invention from one Thermoplastic formed.

As closure elements according to a proposal of the invention Velcro elements used.

According to a particularly advantageous proposal, the lower leg foot Sleeve apparatus on a carbon fiber reinforcement, advantageously one So-called carbon stringer, the medial, lateral and axial plantar on the ankle past until the posterior middle of the calf is inserted.

The invention further relates to a method for producing a lower leg foot sleeve apparatus according to the invention, the following Steps include:

• a) producing a positive model of a lower leg and foot area;
• b) rolling one or more soaked leather blanks onto the Positive model;
• c) sticking the sole of the foot with thick foam cushioning material;
• d) sticking the remaining areas with thin foam cushioning material;
• e) laminating a hard laminate layer in the rear shaft part and in Sole area;  
• f) Laminating a soft laminate layer in the front part of the shaft and in upper foot area;
• g) arranging closure elements and
• h) Forming lockable separation points in the front part of the shaft and in upper foot area.

According to the method according to the invention, a lower leg foot Manufactured sleeve apparatus of the type according to the invention, which is a profiled ax and proven in the healing treatment of diabetic foot syndrome Has.

It is advantageously proposed that after step d positions exposed to pressure can be covered with supporting foam padding. It is also proposed that the leather be glued to the seams becomes. It is essential to avoid that the leather is sewn. The Gluing takes place in a manner known per se, by the leather on both sides sharpened and the edges are glued.

According to a further advantageous proposal of the invention, the Sanded foam pad. In a particularly advantageous manner Foam pad carbon fiber elements applied. According to a proposal by Invention are applied to the foam pads carbon stringer medial, lateral and applied axially plantar past the ankle to the posterior center of the calf and laminated.

According to a further proposal of the invention are used as laminate mats Perlon jerseys used. Finally, the invention proposes that Sand the laminates on the outside.

Of course, the latter grinding can be done using a Surface also take place with regard to the color-shaping paste.

With the invention, a lower leg-foot sleeve apparatus and a Process for its preparation specified, so that a special orthosis with  diabetological soft bedding in a positive model technique in the form of a Multi-component laminate with dermatologically tested leather lining and pressure-distributing, open-cell foam bedding can be produced. In the Positive model technique is based on a plantar partial relief Weight transfer distal to the medial tibial condyle and one full contact below threshold to avoid subcutaneous movement of the skin respected.

The shell construction is dorsal and plantar hard and has a soft front flap with a window in the anterior meleolar area.

The positive effect of the invention, which has already been tested several times The orthosis is based on the combination of materials and the Positive model technology in the overall concept. The development of this The overall concept is the result of several years of research and test series in Collaboration with leading diabetic foot clinics and serves the Treatment for diabetics who already have diabetic foot syndrome or due to neuropathic disorders or microangiopathic processes are about to develop a diabetic foot syndrome.

Further advantages and features of the invention result from the following Description based on the figure. It shows:

Fig. 1 is a schematic partially sectioned representation of a special orthosis according to the invention.

The embodiment of an orthosis 1 shown in Fig. 1 comprises a base part 2 and a shaft part 3. In the area of the front part of the shaft and the upper part of the foot, closures 4 , 5 , 6 and 7 are arranged, for example hook-and-loop fasteners. A window is formed in the antirior, meleolar area. The length of the lower leg can be individually adjusted, so that this results in the number of required closure elements. The entire inside of the orthosis 1 is lined with a leather layer 8 , it being important that all seams are glued and not sewn and that 100% chrome-free leather is used. Upholstery layers 9 , 10 , 11 and 12 are applied to the leather layer, open-cell foams being used. Padding 10 is used in the sole of the foot and is essentially twice as thick as the padding 9 in the shaft area. Additional support padding 11 and 12 are formed at positions exposed to pressure, for example made of a thermoplastic foam.

A carbon stringer 13 is placed on the foam padding medially, laterally and axially plantar past the ankle to the posterior center of the calf. The entire rear shaft area and the sole of the foot area are finally provided with a hard laminate layer 14 , while the front shaft area and the upper foot area are provided with a soft laminate layer 15 .

For the manufacture of such a treatment for a diabetic foot Syndrome usable orthosis is first made a positive form, preferably made of plaster. After reviewing the patient and the Check the mobility in the ankle, taking an ideal one Plaster position of 85 ° is respected over the affected leg Jersey tube pulled. Striking areas exposed to pressure are marked and spacing layers are applied to particularly exposed areas, For example, in four layers of a quick-hardening sprinkled / glued Plaster bandage / longuette. After the spacer layers have hardened, they are added Spread gypsum grease. Then the leg becomes circular with plaster bandages wrapped and massaged. After the position has been corrected Fixation of other plaster bandages wrapped in a circle. Before the curing of the Gypsum negative is the patient with the plaster on a foam pad placed and axially loaded by the technician over the knee, so that an approx. 30 percent partial load results. After plumbing, the plaster cut open and closed again. The plaster patches are removed. Then the plaster negative mold is poured out, so that a Plaster positive form results.

Incidentally, in modeling in a manner known per se Lengthening of the toes, support on the medial joint, smoothing out the Tibial support and the like performed. It is essential that neither Corrections were modeled and supports formed in the area of the foot will.  

To manufacture the orthosis, padding is first applied to the positive cast. The cuts are made from 100% chrome-free leather with a thickness of 1 to 5 mm and the leather is soaked. The leather is rolled onto the gypsum positive as seamlessly as possible, whereby the resulting seams are never sewn. The leather is sharpened and glued on both sides. In the sole of the foot, foam padding is formed from an open-cell foam with a thickness of 8 mm, for example, and sanded. The orthosis is then glued using a 4 mm thick open-cell foam, which is then sanded down. A thermoplastic foam, for example with a thickness of 4 mm, is additionally applied to areas exposed to pressure. The upholstery is thus formed by forming the leather layer 8 , the upholstery 9 , 10 , 11 and 12 .

To form the laminate shells, Pva films are first placed on the Foam padding pulled up. After applying two, for example Layered Perlon jersey, the carbon stringer is plantar medially, laterally and axially Ankle past to posterior mid-calf. On the sole there will be one so-called Bigolow mat, a multidirectional glass fiber mat, likewise about each of the stringers. Again, for example, two layers Perlon jersey applied, and after pulling on another Pva film is in a soft / elastic front area and a hard area in the rear area Lamination done. Suitable resins are from the prior art known.

After curing, after making a tab from LDPE, one so-called Trolenlasche, these glued on. The laminated outer surface is roughened and filled. After applying another four layer mats, Perlon jersey, for example, becomes soft at the front and hard at the back laminated. After these layers have hardened, the orthosis is placed in the front Cut open in the middle of the troll tab. After opening the top Lacing strips and cutting open the bottom flap on the outside the orthosis is removed from the plaster.

For performing soft lamination, for example Solutions of acrylic resins based on methacrylate mainly  Methyl methacrylate and plasticizers preferred, for example one Have a polymer content of approx. 21%. For the hard lamination one Preparation from polymethyl methacrylate, methyl methacrylate, plasticizers based on citrate and a high-boiling ester of methacrylic acid preferred.

The orthosis 1 formed provides a diabetic soft bedding. The acrylic-carbon-glass-nylon laminate mentioned has a dermatologically tested chrome-free leather lining and a pressure-distributing, open-cell foam bedding.

Reference list

1 orthosis
2 foot part
3 shaft part
4 closure
5 closure
6 closure
7 closure
8 leather layer
9 cushions
10 pads
11 cushions
12 pads
13 carbon stringers
14 hard laminate layer
15 soft laminate layer

Claims (16)

1. lower leg-foot-sleeve apparatus consisting of a foot part and a shaft part, which are integrally formed in positive model technology and one forming the rear shaft portion and the sole area hard-laminated shell and one each the front shaft part and the Soft laminated, divisible and with top of the foot Closure elements have a closable shell which is connected to the foot or One after the other with foam padding and one Leather upholstery are provided. 2. lower leg foot sleeve apparatus according to claim 1, characterized characterized in that it has 100% chrome-free leather. 3. Leg and foot sleeve apparatus according to one of the preceding Claims, characterized in that a thick and a thinner flexible padding is arranged in the shaft area. 4. Leg and foot sleeve apparatus according to one of the preceding Claims, characterized in that these are exposed to pressure Has additional supportive padding. 5. lower leg foot sleeve apparatus according to claim 4, characterized characterized in that the support padding by a thermoplastic is formed. 6. Lower leg and foot sleeve apparatus according to one of the preceding Claims, characterized in that the closure elements Velcro straps are. 7. Lower leg and foot sleeve apparatus according to one of the preceding Claims, characterized in that this one Has carbon fiber reinforcement. 8. lower leg foot sleeve apparatus according to claim 7, characterized characterized in that the carbon fiber reinforcement by a  Carbonstringer is formed, the medial, lateral and axial plantar on Ankle over until posterior mid-calf is placed. 9. A method for producing a lower leg and foot sleeve apparatus according to one of claims 1 to 8, comprising the following steps:

• a) producing a positive model of a lower leg and foot area;
• b) rolling one or more soaked leather blanks onto the positive model;
• c) sticking the sole of the foot with thick foam cushioning material;
• d) sticking the remaining areas with thin foam cushioning material;
• e) laminating a hard laminate layer in the rear part of the shaft and in the sole area of the foot;
• f) laminating a soft laminate layer in the front part of the shaft and in the upper foot area;
• g) arranging closure elements and
• h) Forming closable separating points in the front shaft part and in the upper foot area.

10. The method according to claim 9, characterized in that according to the Process step d positions exposed to pressure with supportive Foam pads are provided. 11. The method according to any one of claims 9 or 10, characterized characterized in that the leather is glued to the seams. 12. The method according to any one of claims 9 to 11, characterized in that the foam pads are sanded.   13. The method according to any one of claims 9 to 12, characterized in that that carbon fibers are applied to the foam pads. 14. The method according to claim 13, characterized in that as Carbon fiber a carbon stringer medially, laterally and axially plantar Ankle over until posterior mid-calf is applied. 15. The method according to any one of claims 9 to 14, characterized in that Perlon jersey is used as laminate mats. 16. The method according to any one of claims 9 to 15, characterized in that the laminates are sanded on the outside.