DE2634122A1 - ORTHOPEDIC DEVICE - Google Patents

Description

Patent attorneys Dipl.-Ing. H.Weickmann. Dipj ~ -Fhys. Dr K. Fincke

Dipl.-Ing. F. A. WEICKMANN, Dipl.-Chem. B. Huber

8 MUNICH 86, DEN

PO Box 860 820

MÖHLSTRASSE 22, CALL NUMBER 98 39 21/22

Case FF 5256

Yardney Company,
342 Madison Avenue,
New York, NY / USA

Orthopedic device

The invention relates to an integral, malleable orthopedic device or an integral, malleable orthopedic Apparatus, and represents a further development of the one in the main patent (patent application P 25 16 945.3)

described invention.

The invention particularly relates to orthopedic devices or apparatus with wide medical applications. They are used for this, parts of the body to support, to bring in position or to hold, to protect, to shut down or to immobilize and / or add to keep nurses.

The term "orthopedic device or orthopedic

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Apparatus "includes medical devices such as plaster casts, splints, supports, holders, and other devices used to do so used to support, immobilize, hold together, protect and straighten body parts. They are used in many areas used, including physical medicine or orthopedics, rehabilitation medicine, general medicine, in the field of neurology and for veterinary purposes. They are also used to prevent recurrence to prevent bodily harm and to prevent complaints and subsequent damage.

The different types of known orthopedic devices or apparatus have specific uses, so that it has become necessary for the requirements of a specific one Select a particular type of orthopedic device or appliance. the Treatment of fractures usually requires complete immobilization or immobilization. For this purpose, usually Plaster of Paris casts used. The plaster casts suffer from the disadvantage that they require a curing time of several hours, are extremely heavy, have a low compressive strength, easily crumble or break, have a low water resistance and are only poorly transparent to X-rays. Rails are made of wood, metal and even plastic. Those orthopedic devices or apparatus based on plastics that have hitherto been proposed and / or based on have been brought to market suffer from significant disadvantages in some or all of the applications.

The orthopedic devices or appliances should be functional be light. You should be able to immobilize an area of the body if that is the intended purpose is. Similarly, they should provide resilient support and / or cushion if so desired. The orthopedic The device or orthopedic appliance should be without

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can be further deformed in practice without a Impairment of the patient takes place. Furthermore, the orthopedic device should not have properties that disturb or irritate the patient during use.

Orthopedic devices or apparatus that meet these requirements suffice, are described in the main patent (patent application P 25 16 945.3) of the same applicant.

The object of the present application is now to provide orthopedic devices or apparatus that are shown in can be used in a variety of ways and possess a unique combination of desirable properties.

This object is achieved by the integral, malleable orthopedic device according to the invention, which comprises a plastic plate part which is covered on at least one side with a thermally insulating layer. The plastic plate part or the plastic plate has a thickness of at least 1.02 mm (40 mils). The insulating layer is at least about 0.25 mm (10 mils) thick. The orthopedic device may be deformed or bent with the fingers when the plastic has a temperature of more than about 49 ° C (120 ⁰ F). If the device is heated to a temperature well above its deformation temperature, for example to a temperature of 74 to 177 ^° C (165 to 350 ^° F) and then allowed to cool on the patient in the deformed state, the temperature is on the outside the insulating layer at least about 14 ° C (25 ⁰ F), preferably at least 22 ° C (40 ⁰ F) cooler than the plastic part.

The orthopedic device is on both sides of the plastic plate part coated. The top side covered with the insulating layer is the inner surface the device, d. H. the page that is in use

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facing the body surface. The other side (the Outside of the device) is covered with a fabric layer (hereinafter referred to as "outside" or "other side" or "Protective layer" is referred to), which is preferably a fabric that the plastic material protects. The insulating layer is connected to the plastic, while the outer fabric layer is connected to the Plastic plate part is attached. The outer layer of fabric preferably has a thickness between about 0.10 and 0.56 mm (4 to 22 mils).

The invention thus particularly relates to an integral, malleable orthopedic device which is characterized is that it comprises a plastic plate part that on one side with an insulating layer or an insulating layer and on the other side with a protective layer is integrated,

wherein the plastic sheet member has a thickness of at least 1.02 mm (40 mils), a yield point (tensile strength upon yielding or stretching of at least about 141 kg / cm ² (2000 psi), a flexural strength of between 211 and 984 kg / cm ² ( 3000 to 14000 psi), a flexural modulus of between about 0.035 χ 10

5 5 5

and 0.49 χ 10 kg / cm ² (0.5 10 to 7 χ 10 psi) and one

Has Vicat softening point of between 60 ⁰ C and 80 ⁰ C, and
the insulating layer has a thickness of at least about 0.254 mm (10 mils) and a coefficient of heat transfer of less than

-4 less than about 2 cal / sec / cm ² / cm / ° C χ 10.

Other embodiments. Items and benefits result can be derived from the following description and the examples, in which reference is made to the accompanying drawings.

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In the drawing show:

1 shows a rectangular blank with the structure according to the invention,

2a shows an enlarged sectional view along the line 2-2 of FIG. 1 through an embodiment of the invention,

FIG. 2b shows an enlarged sectional view along the line 2-2 of FIG. 1 of a further embodiment of the invention,

Figure 3 is a perspective view of a molded back support with one corresponding to the embodiment of Figure 2a Structure, and

Fig. 4 is a perspective view of a molded bracer with one corresponding to the embodiment of Fig. 2a Construction.

If the insulating layer is a fabric, it can be a fabric, a felt, a fiber mat, a padded one Act material or a knitted fabric. In the case of a woven fabric, the material preferably has a thickness between about 0.25 to 0.56 mm (10 to 22 mils). Some fabrics, such as felt, can be considerably thicker and have a layer of cushioning form. The preferred insulating fabric is a mixed fiber fabric with a blend ratio of preferably 50:50, the fibers being made of an aromatic high-temperature polyamide, generally referred to as aramid and a crosslinked high temperature phenol-formaldehyde resin such as those made by Collins & Aikman Corp. displaced non-flammable fabrics, which are mixtures of 50% of a high-temperature aromatic polyamide (Nomex's DuPont Company) and 50% of a crosslinked phenol-formaldehyde fiber as described in US Pat. No. 3,650,102) (Kynol Carborundum Company), an aramid fabric can also be used use.

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The insulating fabrics or fabrics can be used in weights of about 135.6 to about 542.4 g / _m 2 (4 to 16 ounces per square yard), and are preferably used in amounts of 169.5 to 271.2 g / ^{m 2.} m ² (5 to 8 oz. per square yard) is used.

The insulating layer should preferably have a heat transfer

-4 coefficients of less than 2 cal / sec / cm ² / cm / ° C χ 10 and more preferably of less than about 1.6 cal / sec / cm ² /

—4
em / ° C. 10 have.

If the insulating layer is a fabric layer, it is preferably attached to the central plastic part with the aid of an adhesive, and more preferably with a thermoplastic adhesive. Since relatively high deformation temperatures, for example temperatures of 204 ⁰ C (400 ⁰ F), can be used to deform the orthopedic device, the thermoplastic adhesive should be a material that forms a bond between the tissue at the temperature used to heat and deform the device and the middle plastic part. Preferably, the adhesive should maintain its properties at temperatures above 93 ⁰ C (200 ⁰ F), said material should (F 350 ⁰⁾ to retain these properties at a temperature of above about 177 ° C in the case of those devices for reasons of an increased safety factor, which are deformed before use.

A polyurethane adhesive, preferably an adhesive, can be used as the adhesive for fastening the outer material. which contains a flexible, thermoplastic polyester-polyurethane. This material has the merit that it has good resistance to sweat, washing and dry cleaning. Although the polyester is preferred to polyurethanes are, you can also use polyether-polyurethanes. One can also use thermosetting polyurethane adhesives, for example

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wise a hydroxyl-terminated hexanediol-adipic acid polyester, which is crosslinked with about 4% 4,4'-diphenylmethane diisocyanate, the material preferably being halogenated to improve the flait instability. An extruded polyester sheet approximately 0.064 to 0.076 mm (2.5 to 3 mils) thick can also be used as a preferred adhesive. It is inserted between the middle plastic part and the fabric layer, whereupon the material at a pressure 0.07 to 0.14 kg / cm ² (1 to 2 psi) to a temperature of about 177 ° C (35O ⁰ F) are heated to connect the fabric to the middle plastic part.

Other, but less preferred adhesives are the acrylates, such as polyethyl acrylate, polybutyl acrylate and polyethylhexyl acrylate, as well as polyvinyl acetate homopolymers and copolymers of ethylene and vinyl acetate. A mixture of the materials mentioned can also be used as the adhesive.

The adhesive can be applied in the form of a thin layer to the middle plastic part, whereupon the fabric layer is applied is placed on the adhesive, for which purpose one usually exerts pressure. This usually leads to the fact that the adhesive in the tissue layer penetrates. When using a sufficiently thin layer of adhesive and a sufficiently high pressure During the connection, direct contact of certain areas of the tissue with the central plastic part can be achieved will.

The fabric can, especially if it is a woven material is to be partially or fully impregnated with a plastic adhesive before applying it to the middle plastic layer brings up. The preferred insulating fabric layers are partially impregnated, with the impregnating Plastic from a surface to a depth of about 0.0025 to 0.178 mm (0.1 mil to 7 mils), and more preferably to to a depth of about 0.0013 to 0.13 mm (0.05 to 5 mils)

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is brought. This results in a thin coating on the surface of the fabric, which is then applied hot (or heated after application) and thereby the impregnated fabric connects to the middle plastic part.

The fabric layer can also be connected to the plastic part by fusing, for example by the plastic heated until it becomes viscous, for example to a temperature above about 163 ° C (325 ° F) and then the fabric connects with the application of pressure with the plastic part, so that the surface of the plastic partially penetrates into the tissue and this firmly connects to the plastic part after cooling.

The insulating layer can also be in the form of a plastic foam layer. The foam layer provides sufficient insulation so that the outer surface of the foam layer can be in contact with the patient without affecting the patient when the plastic plate part is still soft, which is usually a temperature of significantly more than 49 to 54 ° C (120 ° C) up to 130 ⁰ F). The insulating foam layer can also serve to cushion the areas of the patient that come into contact with the orthopedic device.

Since foam layers can be produced, the widely varying Have insulating properties and since the desired degree of padding depends on the application, the The thickness of the foam layer ranges from as little as about 0.25 mm (10 mils) to about 762 mm (300 mils). For most purposes, where a certain padding is desirable and / or not harmful, foam layers with a Thickness between about 3.18 mm and 6.35 mm (125-250 mils) preferred. It can also be thicker layers, for example with layers up to about 12.7 mm (500 mils) thick be suitable for cushioning an area of an orthopedic device;

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- Q -

that comes into contact with a bony area of the patient, especially when this bony area is under pressure exercises against the orthopedic device. For certain purposes, where a very precise definition of the body area is sought without the possibility of movement are relatively thin layers of foam, for example foam layers with a thickness of between about 0.64 and 1.91 mm (25 to 75 mils) suitable. In certain cases a thin layer of foam can mainly be used to since no further advantage is achieved with a thicker layer, so that the thinner layer is more economical.

Preferably the foam layer should be relatively stiff, so that it cannot easily be compressed under pressure. This has the double advantage that the insulating properties of the foam can be maintained when the foam layer is under pressure. This is of particular importance when the orthopedic device is "pressed" against the body as it is deformed. A relative rigid foam layer has the further advantage of allowing more precise adjustment and the amount of movement the portion of the body to which the orthopedic device is applied is kept to a minimum. The foam layer has a cellular structure and exhibits in the plastic material a large variety of pores. The foam can be a closed-cell foam or an open-cell foam with connected pores or a combination thereof. The relative stiffness of the foam is preferably controlled by selecting polymer components which one result in relatively stiff foam.

If the orthopedic device is heated so much that it softens for several minutes during which it is deformed and shaped, the plastic sheet member is usually to a temperature of more than 93 ° C (200 ⁰ F) and

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common (300 F ⁰⁾ and heated to temperatures of at least 149 ° C in certain cases to temperatures of up to about 177-191 ⁰ C (350 to 375 ° F). The insulating foam layer must remain stable at the temperature to which the orthopedic device is heated. If "the foam layer is not stable at these temperatures, the cell structure would collapse as a result of viscous flow, particularly when pressure is applied Destruction of the cellular structure would adversely affect the insulating properties of the foam and also the cushioning properties of the foam, those foams which ^{are stable at temperatures of above 93 ° C (200 0} F) are preferred, with those foams which are particularly preferred are those foams which are stable at temperatures of up to are stable to at least 149 ° C (300 ⁰ F).

Preferably the foam layer should not sustain the combustion, i.e. H. not burn, or at least as good Have flame-retardant properties, such as the plastic plate part, which is preferably formed from a polyvinyl chloride compound. Preferably the foam layer should be in the absence an external flame does not sustain the combustion.

The materials preferred for the production of the foam layer are those flame-resistant firstly and secondly at temperatures (200 ⁰ F) and to be stable up to about 93 ⁰ C, preferably to about 163 ° C (325 ° F). The foam materials that meet these requirements are thermosetting materials or, if they are thermoplastic products, thermoplastic materials that are very high-temperature stable. The foam should also be sufficiently flexible that it can be bent during deformation and should preferably be resistant to perspiration as well as resistant to washing and even dry cleaning.

The materials specified below are particularly preferred materials for forming the foam layer:

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1) Polyolefin foams, for example those prepared from polyethylene, crosslinked polyethylene and polypropylene. The properties of polyethylene foams are given in the Journal of Cellular Plastics (January 1969, pages 46-50), which is hereby expressly incorporated by reference. The fire-resistant polyolefin ^{foams, such as:} the flame-resistant polyethylene, are particularly preferred. A useful method of making polyethylene and other polyolefins flame retardant is to incorporate flame retardant additives such as the Diels-Alder adducts of hexahalocyclopentadiene, such as hexachlorocyclopentadiene, into the polymers. Adducts particularly suitable for this purpose are described in US Pat. No. 3,403,036 and British Pat. No. 1,305,834, to which reference is also made. Together with the specified adducts, the polymers can also be mixed with metal additives, such as antimony trioxide.

2) Polyurethane foams, such as those made from polyether polyols or polyester polyols and mixtures thereof made products. The polyether urethanes are preferred, the flame retardant Polyether urethanes are particularly preferred. The polyether urethanes can by incorporating non-reactive additives be made flame-resistant, for which purpose phosphorus-containing or halogen-containing compounds are usually used, the flame retardants being used in low concentrations in order to prevent deterioration of the foam properties to avoid. A typical non-reactive additive is the chlorinated, phosphorus-containing ester, that of the Monsanto Chemical Company under the designation ·. Phosgard ^ 2XC-20 is manufactured. To achieve flame resistance reactive compounds can also be incorporated into the polyether urethanes. This method · is in the U.S. Patents 3,278,580 and 3,391,092, which are also incorporated by reference. The last mentioned method consists in the basic ingredient for the production of the polyether polyol hexachloro-endo-methylene-tetrahydrophthalic acid (chlorendic acid) to be added. Another method is to

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rin to subsequently treat the flexible foams with fire-proofing agents. This is achieved by that the finished foam in aqueous suspensions of inorganic flame retardants, such as Magnesium ammonium phosphate, and water-soluble binders that are water-resistant after drying. After the foam has dried, it has permanent flame-retardant properties without impairing the foam properties are. Another method of making the polyether urethane foams flame-resistant is to use "highly elastic" Making foams as described in the Journal of Cellular Plastics (July / August 19 72) pages 214 to 217 are described, to which reference is also made. Other useful, flame-retardant urethane foams that are available as Additives tris (dibromopropyl) phosphate and tris (dichloropropyl) phosphate are contained in the Journal of Cellular Plastics (November / December 1970) pages 262-266 and in the Journal of Cellular Plastics (May / June 1972) pages 134-142, to which references are also described is expressly referred to. You can also use fire-resistant polyester urethane foams, such as the materials which together with additional polyether urethane foams in Ind. Eng. Chem. Prod. Res. Develop. Volume 11, No. 4 (1972) pages 383-389. Reference is also expressly made to this literature reference. Further Fire resistant urethane foams are in the Journal of Cellular Plastics (September / October 1971) pages 256 263 described, to which reference is also made.

3) You can also use fire-resistant acrylonitrile-butadiene-styrene foams (ABS foams), which are produced in flame-retardant form from acrylonitrile-butadiene-styrene preparations, which contain, for example, 30% acrylonitrile, 35% butadiene and 35% styrene. The flame retardant materials

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and those for incorporating these products into the acrylonitrile-butadiene-styrene preparations The methods used are essentially the same materials and processes as her are given above in relation to the polyolefin foams.

4) You can also use fire-resistant polyester foams. The polyester foams are usually prepared by reacting a polyol, generally a polyester polyol or a polyether polyol, with a polycarboxylic acid, preferably a dicarboxylic acid such as adipic acid or sebacin * acid. Typical polyols are butanediol and polytetramethylene ether glycol. These polyesters can be given flame-resistant properties by producing the polyester and then soak the finished foam with aqueous suspensions of inorganic flame retardants as it is has been described with regard to polyurethane foams. The flame-retardant properties can also be built into the foam, by completely or partially replacing the carboxylic acid with hexachloro-endo-methylene-tetrahydrophthalic acid (chlorendicacid) as described in US Pat. No. 2,606,910, to which reference is hereby expressly made. The polyester foams are generally prepared by mixing with a blowing agent, for which one method used, which is also used for the production of polyolefin foams.

5. Although polyvinyl chloride foams are generally ^{not stable at temperatures above 71 °} C. (160 ^° F.), polyvinyl chloride preparations blended with acrylonitrile-butadiene-styrene terpolymers can be used for those applications where a stability of above about 93 ^° C. ( 200 ⁰ F) is not required. Post-chlorinated polyvinyl chloride foams are stable at elevated temperatures. These are strongly stabilized thermoplastic materials that result in stable foams.

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6) Suitable foams can also be made from fluorocarbon elastomers which are currently very expensive.

7) Other foam plastics are acrylic, cellulose acetate and epoxy foams, as described in the Modem Plastics Ecyclopedia (1974/1975) on page 720, a literature reference to which reference is expressly made.

The foam layers are prepared using the usual foam-making techniques that are used with foam materials concerned skilled person are known and for example the Modem Plastics Encyclopedia (1974 to 1975) Volume 51, No. 10A (Oct. 1974), pages 125 to 155 are, which is also expressly referred to. The exact components of the foam and the particular procedures employed will depend to some extent on the polymer or polymers from which the Base material of the foam is made. The polyurethanes can thus be foamed in the presence of small amounts of water that foams with the isocyanate to form carbon dioxide, so that no additional foaming agent is required are. In certain cases foaming gases or gas-forming materials are used. For the production of Certain foams, for example those made from polyurethanes and polyesters, can also cause mechanical foaming. The polymer is dispersed in water, for example up to a solids amount of 40 to 65% by weight and then mechanically mixed using a high shear mixer to incorporate air, whereupon the material is poured onto the sheet material and dried by heating to remove the water.

The foam layer can be made using the direct coating method can be formed directly on the plastic plate part or on a fabric layer. One can also

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Apply the transfer coating where the foam material on a release paper (which is generally silicone treated paper) and then transferred to a fabric, the plastic plate part or even a metal substrate and then hardened. Usually, the foam layer is on a fabric or a substrate which is inert to high temperatures, such as a polished metal, formed and then hardened. If a fabric is used, it should be one that is stable at high temperatures Be fabric, for example a fabric made of the high-temperature stabilized polyesters and / or nylons (polyamides). One can also use a needle-punched polypropylene fabric that is stable at high temperatures and has a thickness of about 0.20 to 0.25 mm (8 to 10 mils) in size. Although a fabric can be used, this is used to form one aesthetically pleasing or even decorative effect is not necessary. This effect can affect the surface of the foam can be lent directly using pressure rollers or embossing rollers.

The foam layer can in the usual way on the plastic plate part can be attached, for example by the use of adhesives, the application of pressure, by flame lamination (Flame bonding) etc. The joining method selected depends on the composition of the plastic sheet part and the composition the foam layer. If it is the plastic plate part is a material made of polyvinyl chloride and the foam layer is made of a polyolefin or an acrylonitrile-butadiene-styrene foam the preferred method of the invention is to use an ethylene / vinyl acetate copolymer. to be used as an adhesive. Polyether polyurethane foams and polyester foams are preferably made using one Adhesive connected to the polyvinyl chloride sheet material, including preferably a thermosetting polyurethane, such as a Hexanediol adipate polyester containing hydroxyl end groups is used, which crosslinks with about 4% 4,4'-diphenylmethane diisocyanate

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is. Said thermosetting polyester urethane adhesive is preferably halogenated in order to further increase the fire resistance properties of the orthopedic device. The said Thermosetting polyurethane adhesive is also used for joining polyvinyl chloride foams to a "polyvinyl chloride sheet material suitable.

Preferably, polyester-polyurethane foams are flame-bonded to polyvinyl chloride sheet materials.

Foam layers, preferably those that are large open, or with each other cells connected (at least on and in the vicinity of the surface) can be associated with the thermoplastic Plate part are connected by heating the thermoplastic plate part until it softens and then the plate part and compressing the foam layer together, for example by applying the heated thermoplastic sheet member and the foam layer leads through rolling. Strength and bending properties the orthopedic device at room temperature are mainly due to the central plastic part. This part is strong or firm and has the ability to be elastic with a certain shape and size. With certain If shaped differently, it is essentially stiff, especially if it has an O-cross section, an L-cross section, a U-cross section etc. owns. The device can be shaped in various ways and, in certain areas, essentially rigid or rigid and be relatively elastic in certain other areas.

The diverse applicability of the orthopedic according to the invention Devices results from the following properties of the plastic plate. From a plate (with a thickness of Various shaped devices are prepared from 2.29 to 2.36 mm (90 to 93 mils) of the following composition. A plate with a length of 161.9 mm (6 3/8 inches) is used for this.

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Prepare a device with an O-section, the has a tube radius of 2 0.6 mm (13/16 inches). That Pipe is held in place with clamps at both ends. It is supported at two points on the underside, the 101.6 mm (4 inches) apart, loading the center of the pipe from above. The bending results as follows:

Bending in mm (inches) Load in kg (pounds) 2 ₇ 54 (0.1) 22.5 (49.5) 5.08 (0.2) 23.2 (51.2) 7, 62 (0.3) 36.5 (80.5) 10.2 (0.4) 47.2 (104.0) 12.7 (0.5) 56.7 (125.0) 15.2 (0.6) 64.4 (142.0)

(a) The deflection or machine deflection includes the bending of the pipe over the entire length and the flattening of the Rohres at the three points of attack.

Prepare a device with a U-Ou section with a Width of 60.33 mm (2 3/8 inches) and a radius of curvature of 23.0 mm (29/32 inches). The structure is assembled in such a way that that the arms of the "U" are horizontal, whereupon the upper arm is loaded. A constant load study gives the following results:

Point where the constant load (0.454 kg) is applied (distance in cm (inches) from the center of the "U")

29.21
44.45
69.85
95.25
120.65

(1.15) (1.75) (2.75) (3.75) (4.75)

Deflection in mm (inches) at constant load (logarithmic)

1, 27 (0.050) 2.41 (0.095) 3.43 (0.135) 4.45 (0.175) 29.08 (1,145)

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An examination at constant deflection gives the following values:

Places where the constant deflection of 11.43 mm (0.45 inches) (distance in mm (inches) from the center of the "U")

Load in kg (pounds) at constant deflection (logarithmic)

120.65 (4.75) 92.25 (3.75) 69.85 (2.75) 44.45 (1.75) 29.21 (1.15)

0.14 (0.30)

0.27 (0.60)

0.54 (1.18)

3.90 (8.60)

4.87 (10.73)

Prepare two "L" shaped cross-section devices by clamping them vertically and at right angles bends. The load is applied vertically to the horizontal arm. The results of the study under constant load a sample 6.19 mm (2 7/16 inch) wide and 6.35 mm (1/4 inch) radius are as follows specified:

Places where a constant load (0.908 kg (2 lbs.) Is applied becomes (distance in mm (inches) from the center of the bend)

Deflection in mm (inches) at constant load (logarithmic)

12.70 (0.5) 25.40 (1.0) 38.10 (1.5) 63.50 (2.5) 88.90 (3.5) 114.30 (4.5)

0.254 (0.010) 0.635 (0.025) 1,778 (0.070. 7.112 (0.280) 12.272 (0.680) 29.210 (1,150)

The results of the constant deflection test on a specimen 60.32 mm (2 3/8 inch) wide and a radius of 23.0 mm (29/32 inch) are given below:

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Places where a constant load in kg (pounds) at

Deflection of 8.89 mm (0.35 inches) constant deflection (lo-

is reached (distance in mm (inches) from the center of the bend)

114.3 (4.5) 88.9 (3.5) 63.5 (2.5) 38.1 (1.5) 25.4 (1.0)

0.227. (0, 50) 0.454 (1, 00) 1, 030 (2, 27) 5.44 (12, , 00) 18.14 (4O ₁ , 00)

The physical properties of plastics vary in some ways with the thickness of the examined section. Specific physical properties such as rigidity and / or the elasticity of the orthopedic support device vary with the thickness and overall size of the middle Plastic layer. The middle plastic layer usually has a thickness between about 1.27 and about 3.05 mm (50 to 120 mils), although thicker layers, for example up to about 6.35 mm (150 mils) can be used for large area devices such as plaster casts for the Hulls that use thicknesses of about 5.08mm (200 mils) for those that are used for the sake of supporting a great deal of weight considerable rigidity is required. Thick sections, for example, a thickness of about 3.81 to 4.32 mm (150 to 170 mils) can be applied to orthopedic devices used to support the areas of the body precisely defined for radiation therapy. Blanks, d. H. flat devices used for the production of Back supports are preferably about 1.65 to 2.03 mm (65 to 80 mils) thick. Blanks for rails and brackets are preferably about 2.03 to 3.05 mm (80 to 120 mils) thick. The preferred Blanks for heavily shaped plaster casts can have different thicknesses depending on the final shape and thickness depend on usage requirements. When thin devices, for example a middle plastic part with a thick from 1.02 to 1.27 mm (40-50 mils) can be used

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Additional strips or plastic plates can be attached to the outside to reinforce the device.

The plastic preferably has a tensile strength at yield between 141 and 703 kg / cm ² (2000 to 10000 psi) and more preferably 352 to 56Γ kg / cm ² (5000 to 8000 psi) ( ASTM D-638). The middle plastic layer is relatively stiff, which is reflected in a percentage elongation at the yield point (or when yielding) of about 3 to 30% and even more preferably of about 4 to 8%. The properties at the yield point or the yielding or flow of the material are more important than at breakage, since the yield point should not be exceeded during use.

The flexural strength (ASTM-790) is between 211 and 954 kg / cm ² (3,000 to 14,000 psi), more preferably between 562 and kg / cm ² (8,000 to 12,000 psi). The flexural module (ASTM-790)

lies between 0.035 χ 10 ⁵ and 0.49 χ 10 kg / cm ² (0.5 to 7

5 5

χ 10 psi) and preferably between 0.14 χ 10 and 0.35 χ 10 (2 to 5 χ 10 psi) Notched Izod impact strength (ASTM D-256) in kpm / cm (foot-pounds per inch) is between 0.016 0.16 (0.3 to 30) and preferably between 0.027 and 0.816 (0.5 to 15.)

The Rockwell hardness is between 15 and 55 in the scale R (ASTM-1525-70 D) is in the D scale and preferably between 90 and 100 in the scale R. The Vicat softening point between 60 ⁰ C and 80 ° C.

A sample of a preferred and impact-resistant modified polyvinyl chloride plastic part, which is given in the example, has an average (+7.03 kg / cm ² (+ 100 psi)) yield strength or

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Tensile strength at yield of about 531 kg / cm ² (7550 psi) and a tear strength or breaking strength of about 267 kg / cm ² (3800 psi) ASTM D-638). The average (+ 0.5%) elongation at the yield point is 5%, while the average percentage elongation at break is 14.2%. The average flexural strength is 0.75 χ 10 kg /

cm ³ (10.8 χ 10 psi) during the bending modulus of the material χ 0.29 10 ⁵ kg / cm ² (4.1 χ 10 ⁵ psi) (ASTM D-790) is.

Another sample made from the same material has a yield point of 477.0 kg / cm ² (6785 psi), an elongation at yield of

5 5

5.6%, a flexural modulus of 0.277 χ 10 kg / cm ² (3.94 χ 10 psi), a flexural strength of 816.3 kg / cm ² (11612 psi), a Rockwell hardness R of 94, a Vicat Softening point of 74 ° C and a notched Izod impact strength of 0.050 kpm / cm (0.91 foot pounds per inch) »

Another sample of the same composition that has been worked through significantly during processing but has been found suitable has a yield strength of 254.5 kg / cm ² (3620 psi), an elongation at elongation of 4.5%, a flexural modulus of 0.075 χ 10 kg / cm ² (1.06 χ 10 psi), a flexural strength of 261.8 kg / cm ² (3724 psi), a Rockwell hardness R of 19, a Vicat softening point of 63 ° C and an Izod Notched impact strength of 0.68 kpm / cm (12.5 foot pounds per inch).

The middle plastic part can be made from different polymer systems be constructed, such as vinyl chloride-propylene copolymers, vinyl chloride / ethylene copolymers or equivalent Interpolymers containing diallyl maleate. Preferably a polyvinyl chloride improved in terms of impact resistance, which is a polyvinyl chloride resin, is used with a number average molecular weight of 20,000 to 23,000. The preparation or the plastic mass contains about 100 parts of the polyvinyl chloride homopolymer

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10 to 14 parts of an impact modifier, 1.25 to 2 parts of a lubricant and 7.5 to 8.5 parts of a plasticizer. The preparation or mass can also Stabilizers (6 to 9 parts), various processing aids (1.5 to 2.1 parts) and usually "pigments (up to 5 parts) included.

A preferred polyvinyl chloride composition has the following composition :

Components of preferred preferred mass

Area (depth) se (parts)

Polyvinyl chloride homopolymer (20,000 to 23,000) impact modifier (methyl methacrylate / butadiene / styrene polymer) Processing aid (acrylic material from Rohm & Haas K-120 N)

lubricant

Mixture of an olefinic monoglyceride and hydrogenated olein

Tristearyl citrate

Plasticizer (di-2-ethylhexyl phthalate) Agent for enhancing the stabilizing effect of epoxidized soybean oil

mixed di- and tri-nonylphenyl-phosphite

Polyvinyl alcohol

Stabilizers

Calcium stearate

Tin (II) stearate

Zinc stearate

Pigments

Rutile TiO ₂

red pigment (Hösterperm Red) orange pigment (Indofast Orange)

100 100 10-14 12.0 1.5-2.1 1/8 1-1.5 1.25 0.25-0.35 0.3 7.5 - 8.5 8.0 4 - 6 5.0 1.25 - 1.75 1.5 0.05-0.08 0.0675 0.24-0.30 0.27 0.37-0.43 0.40 0.28-0.34 0.31 2.5-3.5 3.25 0.0054 0.0135

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Prepare a sheet of polyvinyl chloride approximately 2.03 to 2.29 mm (80 to 90 mils) thick from small spheres about 3.18 to 4.76 mm (1/8 3/16 inch). The granules are heated in an extruder and the resin is extruded in the form of a strand-like material with a About 12.7 mm (0.5 inch) diameter that then with rollers ground and with the help of calender rollers to form a sheet or plate with a thickness of 0.38 to 0.51 mm (15 to 20 mils) is processed. Four sections of this plate are laminated in a press with a heated ram to form of panels approximately 2.03 to 2.29 mm (80 to 90 mils) thick. The physical properties of this sample board are given above. Further details regarding the plastic compositions and their manufacture can be found in the main patent (patent application P 25 16 945.3)

of the same applicant, expressly incorporated herein by reference may be.

The polyvinyl chloride sheet material can be produced by heating the small spheres of the polyvinyl chloride composition in an extruder and extruding them directly into a sheet of the desired thickness. An alternative method is to mill a strand material with a diameter of about 12.7 to 101.6 mm (0.5 to 4 inches) and roll it out with the aid of a kaiander. With the aid of these procedures and, in particular prepared by directly extruding material has voltages so that the voltages are preferably eliminated by reacting at temperatures of about 160 ⁰ C (320 ⁰ F) tempers the material · or subjected to a Wärmebehandiung. You can do that. Tempering or the heat treatment at the same time. effect the application of an adhesive or an adhesive and a fabric.

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The outer layer, which is preferably made of a fabric (but which can also be made of any other material, such as a Metal layer can be built up) protects the plastic surface the flat orthopedic device during transportation, storage and handling prior to deformation and also after the device has been molded. If a heating element in direct contact with the orthopedic device, e.g. a hot iron is used, the outer layer of fabric prevents the plastic from sticking ' on the heating element.

The outer layer, together with the insulating fabric layer, also supports the cohesion of the orthopedic device, when this is heated to elevated temperatures. Since the outer fabric layer is bound to the plastic, tensions arise, when the orthopedic device is curved and the outer layer of tissue is on the outside of the curve is located. Therefore, one preferably uses an elastic or stretchable material that is at room temperature and in particular at the increased processing and / or molding temperatures does not exert any tension on the plastic layer and this too seeks to deform.

During the heating, the outer fabric layer can be subjected to very high temperatures. The preferred fabrics are those which can be ^{heated to 121 °} C. (250 ^° F) for a long time and to significantly higher temperatures for a short time. These high-temperature-resistant fabrics include the high-temperature-stabilized nylons (polyamides), the high-temperature-stabilized polyesters, the polyurethanes (spandex), the aramids (such as the Nomex material), the high-temperature-resistant acrylic plastics, the mixtures of 50% Kynol and 50% Nomex (available from from Collins & Aikman) and especially the lighter fabrics, as well as linen. The nylons or polyamides, polyesters and aramids mentioned are preferred.

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For devices that are not heated to elevated temperatures
that are available in blanks, which already have the desired final shape and which are only heated for the adaptation, can be suitable for lower temperatures
Use fabrics such as cotton and wool.

The outer fabric layer has a thickness of at least about 0.10 mm (4 mils), more preferably a thickness of about 0.10 to 0.56 mm (4 to 22 mils), and most preferably a thickness of about
0.25 to 0.38 mm (10 to 15 mils) ·. The fabric layer is preferably attached to the central plastic part with the aid of a plastic, for example a thermoplastic polyurethane resin. Thinner outer layers can also be used, for example metal layers applied to the plastic plate part or other layers with a thickness of 0.025 to 0.051 mm (1 to 2 mils). The protective layer need not cover the entire surface of one side of the plastic plate, ie certain areas of the plastic can be covered with reinforcing plastic strips.

The outer fabric layer can be connected to the middle plastic layer. The othopedic devices can be produced by first attaching an insulating layer of tissue
attached to the middle plastic part by a three-layer material consisting of the middle plastic part, an extruded polyester film having a thickness of about 0.064 to 0.076 mm (2.5 to 3 mils) and the fabric described above with a basis weight of 237.3 g / m ² (7 oz. Per square yard) (Collins
& Aikman) with a dwell time of 18 seconds through a roller press (Reliant) which is brought to a temperature of 177 ^° C
(350 ⁰ F) is heated and a pressure of 0.07 to 0.14 kg / cm ²
(1 to 2 psi). A thermoplastic material is used as the extruded polyester film. Then you attach the
another fabric layer with a basis weight of 135.6 g / cm ²
(4 oz per square yard) (Collins & Aikman) on the other side of the middle plastic part by placing the middle plastic part described above, coated with the insulating fabric

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together with this fabric and an interposed sheet of polyester film with a thickness of 0.064 to 0.076 mm (2.5
up to 3 mils) under the stated conditions through the roller press (Reliant). The orthopedic device is preferably produced by simultaneously leading the two outer layers and the middle plastic part and the corresponding adhesive layers, which can be previously applied to the fabric or the plastic foam, through the roller press, so that
the integral orthopedic device is obtained with a single pass. The blank of the orthopedic device can also be produced by extruding the plastic plate part onto a coated fabric or by forming the fabric layers and the plastic plate together with the adhesives lying between them by extrusion.

At the deformation temperatures, the orthopedic device can be easily cut. This can be done with the action of
Shear forces take place, for example with the help of scissors or some other sharp-edged device. The orthopedic devices, which are covered with layers of tissue on both sides of the plastic part, maintain their cohesion even at elevated temperatures. If the orthopedic device is to be deformed to a significant extent, for example to form a serpentine product by helically wrapping several layers of the orthopedic device on top of one another, higher temperatures can be used, for example temperatures of up to 121 to 204 ⁰ C (250 to 400 ⁰ F) . At these temperatures, the device retains its cohesion, but can without
further folded. The orthopedic device can be cut with the plastic not leaking out from between the outer layers. When the orthopedic device is heated to these high temperatures and then from the heat source
removed, it can last for a period of up to about
Can be deformed and processed for 6 to 10 minutes. The raw deformation occurs when the orthopedic device begins to cool from the elevated temperature. After the outer surface of the insulating layer has cooled sufficiently, the device can

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device can be pressed against the corresponding body portion and brought into the desired final shape, the pressure in general is exercised with the fingers. After the orthopedi- ' see device is applied to the body, is sufficient Time is available during which the final deformation to the desired body shape and / or device shape can be achieved can.

The orthopedic device can be heated in a fluid bath at a constant temperature, for example a water bath, a hot oven or under the action of radiant energy. The orthopedic device is preferably only heated from the side which does not come into contact with the body surface of the patient. This can be done by applying radiant heat, with the help of a hot air blower or a hair dryer, whereby, due to the availability, preferably hot plates or bowls and hot irons in the form of a household iron or in the form of a specially shaped round or curved iron are used. It has been found, surprisingly, that the hot surface of an iron including a temperature of 149-160 ⁰ C - can have (300 500 ⁰ F), can be applied to the fabric layer of the orthopedic device, and to heat it to temperatures can in which the device can be readily deformed so that it can be cut up and formed into extraordinarily intricate molded parts. The heat source is then removed from the orthopedic device and / or reapplied intermittently, whereupon the device is then placed on the corresponding body section and brought into the desired shape. Shaping can be achieved by applying finger pressure. The person applying and shaping the orthopedic device can wear gloves. If a hot cup or plate is used and the device is provided with a protective bell, a temperature of 93 ° C (200 ⁰ F) sufficient to during an appropriately long period of time, the device feeding the amount of heat 'bility to deformability sufficient for the desired processing time.

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The upper limit temperature that can be allowed to act on an area of the human body depends on the skin area in contact with the heat, the contact time and the individual tolerance for high temperatures. For applying the orthopedic devices, the temperature should not be above about 49 to 52 ⁰ C (120 to 125 ⁰ F) for a short contact and should (120 F ⁰⁾ can be kept below 49 ° C preferably at a contact of several minutes.

When the blank of the orthopedic device is already cut and only has to be deformed, it can from one side to a temperature of about 74-107 ⁰ C (165-225 ° F) are heated, after which the blank, when the outer side of the insulating fabric layer is sufficiently cool, placed on the patient's body and brought into the desired shape.

The middle plastic part of the orthopedic device according to the invention solidifies at a temperature of about 53.9 to 54.4 ⁰ C (129-130 ⁰ F). Accordingly, it is necessary that should be the temperature of the central plastic part during molding of above about 54.4 ° C (130 ⁰ F). Since exposing the patient's skin to this temperature for more than a very short time is uncomfortable and potentially dangerous, the external temperature of the insulating fabric layer should be at least 14 ⁰ C (25 ° F) cooler than the temperature the central plastic part is during comprising of deforming, wherein the outer fabric layer is preferably at least 17 ° C (30 ⁰ F) cooler is. More preferably, the external temperature is at least 19 ° C or 22 ° C (35 or 40 ⁰ F) below the temperature of the plastic part. This is particularly true when using a plastic deformation ^{temperature in the range from 54.4 to 71 °} C (130 to 160 ^° F). The temperature, soften at the plastic plate parts and therefore allow deformation of the orthopedic device can be adjusted in such a way by changing the Polyvinylchloridzubereitung the middle plastic plate to be about 48.9 to 50.6 ⁰ C (120-123 ⁰ F) to. is about 63 to 69 ° C (145-155 ° F). The above

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The temperature difference can be greater and for example at least 28 ° C (50 ⁰ F) or 33 ° C (60 ⁰ F) if the device softens at a higher minimum temperature, for example at a temperature above about 63 to 69 ⁰ C (145 - 155 ° F). An insulating foam layer is particularly suitable.

According to a preferred embodiment of the invention, the heat is allowed to act on the side of the orthopedic device, which is covered with the outer fabric layer. For certain purposes, you can use both sides of the middle plastic part cover with an insulating material. This allows the entire part to be heated to an elevated temperature, so that it stays warm for a long time.

The molded orthopedic device can be any shape which depends on the intended use and in particular the area of the body to which it is applied. To manufacture lies the orthopedic. Device in the form of a Plate material »For most purposes, these plate blanks are available in different sizes, for example in Shape of squares with a side of about 10.2 cm (4 inches) up to about 61 cm (2 feet) or more, for example in the form of sheets with the dimensions 61x122cm (2x4 feet) or more. You can also use rectangular, oval or round blanks prepare. These blanks comprise the middle plastic part in the form of a plate, on one side the insulating layer and on the other side has the other layer. These blanks have an overall thickness that is slightly less than the sum of the thickness of the middle plastic part plus the thickness of the two outer layers, since with the help of manufacture a press or usually with the aid of press rollers, a pressure is exerted on the material.

Further embodiments, objects and advantages result from the following examples, in which reference is made to the accompanying drawing.

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In the drawing show:

Fig. 1 a rectangular blank (flat orthopedic device) 10 with a protective fabric layer 13 on one side of the plastic plate 12 and the insulating layer 11, 20 on the other side;

2a and 2b are sectional views of two embodiments of the Invention along line 2-2 of Figure 1;

2a shows a preferred embodiment of the invention, according to which the insulating layer 11 is arranged on one side of the plastic plate 12, while on the other side the protective fabric layer 13 is arranged on the plastic plate 12. The relative thicknesses of the layers are not to scale in any of the drawings and are for explanatory purposes only;

Fig. 2b shows a preferred embodiment of the invention in which one side of the plastic plate 12 is covered with the protective layer 13 and the other with the insulating layer 20;

Figure 3 shows a shaped back support 14 with contours represented by areas 15 and 15 '. The middle area 19 is relatively rigid and supports the spinal column area, while sections 15 and 15 'are somewhat more elastic and support the back and adjacent lower body areas;

4 shows an arm splint 16 with a hand area 17, a wrist area 18 and a forearm area 19, wherein the insulating foam layer 20 (the one at the edges not is shown) on the inner surface and the protective layer 13 on the outer surface are.

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The following examples are provided for further explanation. All Unless otherwise stated, parts and percentages are based on weight.

example 1

A flat or planar blank of an orthopedic device is prepared from a piece of plastic sheet with a thickness of 2.31 to 2.36 mm (91 to 93 mils) from a material of the composition given in the right-hand column of the table above and coated the plate on one side with an insulating fabric, which is a non-burning fiber mixture (50% Kynol and 50% Nomex), which is described above. This insulating fabric has a basis weight of about 237.3 g / m ² (7 oz. Per square yard) and a thickness of about 0.36 mm (14 mils). The material is impregnated on one side with a thermoplastic, flexible polyester-polyurethane adhesive to a depth of about 0.076 mm (3 mils). The impregnated side also has a thin coating of this material. This fabric is connected to the plastic part by heating the impregnated, insulating fabric to a temperature of about 163 ° C (325 ° F), placing the material on the plastic sheet and applying gentle pressure. The other side of the plastic sheet is covered with a knitted fabric of stabilized nylon (polyamide) about 0.36 mm (14 mils) thick and similarly impregnated with the same adhesive. The material is attached to the plastic part in a similar manner.

Example 2

100 parts by weight of a finely powdered (with, for example a particle size of 40 to 50 μπι), partially crosslinked Polyethylene, which gives a generally rigid but flexible foam, with 6 to 10 parts by weight of a titanium dioxide pigment and about 4 parts by weight of bisazodicarbonamide, whereupon until it

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hold a homogeneous mass mixes. The material is then prepared in the form of a thin layer on a silicone-coated paper and passed through an oven heated ^{to 170 to 190 ° C. with a dwell time of about 10 minutes.} The bisazodicarbonamide decomposes releasing nitrogen, which causes the formation of a foam. The resulting foam layer is about 3.18 mm (125 mils) thick. Prepare another, thicker layer about 6.35 mm (250 mils) thick. The freshly made foam is then quickly cooled by passing it through a basin of cold water. The foam obtained is sufficiently flexible that it can be folded over. It has a density of 66 kg / m ³ (4.1 pounds per cubic foot). In the skin area, the pores are predominantly closed-cell pores.

Attach a sheet of the above foam approximately 3.18 mm (125 mils) thick and a sheet with a thickness of 6.35 mm (250 mils) on the panel made of polyvinyl chloride of the middle plastic part, using the above thermosetting polyurethane adhesive described is used. The other side of the polyvinyl chloride plate is coated with the tricot fabric as described in Example 1. The device obtained is an orthopedic device excellently suited. The disadvantage is that the polyethylene is not fire-resistant.

Example 3

The measures of Example 2 are repeated using a refractory mass containing 75 parts by weight of polyethylene, 25 Parts by weight of the Diels-Adler diadduct of hexachlorocyclopentadiene and 1,5-cyclooctadiene, 10 parts by weight of antimony trioxide, Contains 6 to 10 parts by weight of titanium dioxide and about 4 parts by weight of bisazodicarbonamide. Instead of the one described in Example 2 For a thicker layer of the insulating foam, a third layer of foam with a thickness of about 1.27 mm is used (50 mils).

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Example 4

Example 2 is repeated, but instead of the polyethylene foam from Example 1, a polyethylene foam with a density of 64 kg / m ³ (4.0 pounds per cubic foot), a thermal conductivity of 1.38 cal / sec / cm ² / cm / ° C-10 ~ (0.40 Btu / Sq.ft / h ° F / inch), a water vapor permeability of

<0.40 perm-inch and one determined according to ASTM regulation D2842 Water absorption of <0.50 percent by volume (96 hours) begins.

Example 5

Example 2 is repeated using a crosslinked polyethylene foam having a density of about 64 kg / m ³ (4 pounds per cubic foot), one in accordance with ASTM D2326

4 determined thermal conductivity of 1.38 cal / sec / cm ² / cm / ° C · 10 (0.40 Btu / ft ² / h / ° F / inch), a water vapor permeability determined according to ASTM regulation C355 of <0, 40 perm-inch and a water absorption determined according to ASTM regulation D2842 of - «(0.50 percent by volume (96 hours).

Example 6

Example 2 is repeated using a commercially available fire retardant polyurethane foam having a flammability according to SE ASTM classification D1692-68 (self-extinguishing) and a density of 67 kg / m ³ (4.18 pounds per cubic foot). In place of the thicker foam layer described in Example 2, a foam layer about 0.64 mm (25 mils) thick is used.

Example 7

The measures of Example 2 are repeated, using a flame-retardant composition comprising 60 parts by weight of polypropylene, 27

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Parts by weight of the Diels-Alder diadduct of hexachlorocyclopentadiene and 1,5-Cyclooctadiene, 13 parts by weight of antimony trioxide, 6 to 10 parts by weight Contains titanium dioxide and about 4 parts by weight disazodicarbonamide.

Example 8

Example 2 is repeated using a flexible polyurethane foam with a density of 32 kg / m ³ (2 pounds per cubic foot) and a thermal conductivity of 1.03 cal / sec / cm ² / cm / °, determined according to ASTM specification D2326 C-10 ~ ⁴ (0.3 Btu / ft ² / h ° F / inch)

Example 9

Example 2 is repeated using a highly resilient polyurethane foam having a density of 43 kg / m ³ (2.7 pounds per cubic foot) and a flame resistance rating of SE (self-extinguishing) determined according to ASTM D1692.

Example 10

Example 9 is repeated using a flexible polyurethane foam, as described in Example 4 of US Pat. No. 3,391,092, which is incorporated herein by reference.

The thermal properties and the Abkühlungsexgeschaften of the various components of the orthopedic device after the heating of the material to high temperatures, for example to a temperature of about 149 ° C (300 ⁰ F) of a flat blank having approximate by the following time-temperature profile Dimensions of 16.5 χ 16.5 cm (6.5 χ 6.5 inches) illustrated. The center plastic part is approximately 1.75 mm (69 mils) thick. The insulating fabric is the incombustible material described above with a basis weight of 237.3 g / m ² (7 oz. Per square yard) (from Collins & Aikman), which has a thickness of about 0.38 to 0.46 mm (15-18 mils). The other fabric is a knitted fabric with

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ο - 35 -

a blend of stabilized nylon (polyamide) and polyester about 0.31 mm (12 mils) thick. Both fabrics are connected to the plastic part by applying an adhesive to one side of the plastic part, then laying the fabric on top and finally using a hot iron to bring the fabric and the adhesive to a temperature in the range of about 177 to 193 ° C (350 heated to 380 ⁰ F). The adhesive is applied to a thickness of about 0.076 mm (3 mils). The insulating fabric is attached using the thermoplastic polyurethane adhesive described above. The heat-curable polyurethane described above, which contains about 4% of the crosslinking diisocyanate, is used as the adhesive for the tricot fabric.

Thermal properties are tested by first heating the device and then allowing it to cool again in air (room temperature, about 20.6 to 21.7 ° C (69-71 ° F)) while determining the rate of cooling arranged such that the surface coated with the tricot fabric side is parallel away from the hot plate at a distance of about 9.53 mm (3/8 inch). the hot plate has a measured surface temperature of about 209 ⁰ C (409 ⁰ F The device is heated to the temperatures given in the following table, after which it is allowed to cool: A thermocouple To is attached to the surface of the central plastic part, which is connected to the tricot, while a thermocouple To is attached to the one with the insulating On the side of the plastic part provided with the fabric, a thermocouple T. The temperature profile results as follows:

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Heat

Remove the heat source cool down

Time (minutes) temperature, ⁰ C ( ⁰ F)

^T 4 ^T 3

O 27.8 (82) 27.8 (82) 10 88.9 (192) 98.3 (209) 17th 106.7 (224) 112.2 (234) 21, 5 131.1 (268) 161.7 (323) 0.5 128.3 (263) 140.0 (284) 1.0 122.2 (252) 130.6 (267) 1.5 116.7 (242) 121.7 (251) 2.0 108.3 (227) 113.9 (237) 2.5 103.9 (219) 107.2 (225) 3.0 96.7 (206) 100.6 (213) 3.5 90.6 (195) 93.9 (201) 4.0 85.6 (186) 88.9 (192) 4.5 80.6 (177) 83.3 (182) 5.0 75.6 (168) 78.3 (173) 5.5 71.7 (161) 74.4 (166) 5.8 69.4 (157) 71.7 (161) 8.0 55.0 (131) 56.7 (134) 10.0 46.1 (115) 47.8 (118) 11.5 41.1 (106) 42.2 (108)

By physical manipulation of the apparatus can be seen that the deformation length is then completed, ie that the plastics material has then solidified when the resin temperature (130 ⁰ F) is about 54.4 ⁰ C. In certain cases, this value will be closer to 53.9 ° C (129 ° F), which is within the range of measurement accuracy. The same device is reheated several times, each setting at about 130 ° F (54.4 ° C) Other samples soften at slightly lower temperatures, such as temperatures from 124-127 ° F (51.1 to 52.8 ° C) .

These values are in agreement with the experience that the same device deforms completely or partially several times or even completely or partially completely redesigned

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can be. This can cause a bad fit Correct shape errors and even adjust the shape of the device during use. This also opens up the possibility the reuse of the device, which is undoubtedly important for poorer countries. Orthopedic devices, which have an insulating foam layer instead of the fabric layer, allow an even longer period of time Deformability, whereby an at least as great protection for the patient is achieved.

The above time-temperature profile also illustrates the fact that from the removal of the heat source to the occurrence of solidification there is a period of more than 8 minutes, during which the device can be deformed or shaped. Practical tests on a series of samples, which have the nylon-polyester fabric on one side and the non-burning insulating fabric (Collins & Aikman) on the other, show that when the device is heated to a temperature of more than 149 ° C (300 ⁰ F) and is preferably heated to a temperature of 163 ° C (325 ° F), at least 7 1/2 minutes are available, during which the deformation can be achieved. Investigations on other experimental devices, in which the other fabric consists not of a nylon-polyester material but, for example, of cotton, have shown that other cooling times can result before solidification, and that these times are noticeably shorter in certain cases and for example only be 4 1/2 minutes.

The actual cool down time of a given device will vary with the overall thickness and other dimensions of the device, as well as the heating-up time, the temperature ultimately reached and the cooling conditions. The devices with an insulating Foam plastic layer, preferably those with thick ones Layers, such as those 3.18 to 6.35 mm (125-250 mils) thick, cool more slowly and make one greater temperature difference between the outside of the foam layer and the plastic plate part, for example one

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Temperature difference of at least 30.6 to 33.3 ⁰ C (55-60 ⁰ F).

Temperature determinations are also carried out on the outside of the insulating fabric layer during the recording of the time-temperature profile and during the other heating and cooling tests. It is found that using the above-mentioned non-flammable fabric with a basis weight of 237.3 g / m ³ (7 oz. Per square yard) (Collins & Aikman), there is a temperature difference between the outside of the fabric and the Plastic achieved about 22.2 ° C (40 ⁰ F). The temperature measurements show a variation of + 5.6 ° C (+ 10 ⁰ F) in certain cases, although they are generally within a range of + 2.8 ° C (+ 5 ° F).

If the orthopedic device blank is severely deformed at temperatures above about 163 ° C (325 ° F); H. if some Areas are bent about an axis and other areas are bent about an axis that is perpendicular to or intersects this axis, Some displacement of the plastic can take place within the outer layers, so that the resulting shaped (and normally shaped) device may no longer be of uniform thickness in certain cases.

Some practitioners fitting orthopedic appliances or appliances prefer to trim the outer edge of a finished product, especially when it is a relatively complex device, on the (flat) blank of the orthopedic device recorded before the material is cut and shaped into the raw shape. This may depend on the existing tissues are done in different ways. Certain fabrics, for example the fabric mixture described above from Kynol and Nomex can be written with a writing instrument, for example a pen, a pen, a chalk, etc. be labeled. Alternatively, you can use a self-adhesive glue to apply a layer of paper to one of the surfaces attach. The surface of the paper can then be written on and used as a pattern, whereupon the orthopedic appliance is cut and shaped. The paper can immediately after

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_ OQ _

can be removed after cutting or, in certain cases, can advantageously be left on the device until the raw deformation is carried out. It can then be peeled off the outer layer.

The orthopedic devices of the invention have a number of advantages. They enable elastic support if they are used as relatively large, not strongly curved support devices, how back supports are used. As a substitute for plaster casts, they can set aside the concerned Enable body areas. When used to fix a part of the body in a bent position, for example as a knee brace, it only needs to be laid down in one direction. The orthopedic devices are for those cases of particular importance where it is desired to adapt the shape of the device for a prolonged period of time. Thus, a change in position may be desirable when the patient responds to treatment. In the past When using plaster casts, the old casts had to be removed and replaced with new plaster casts. The invention Orthopedic devices, even when attached to the body, can be applied locally of heat and corresponding deformation.

One of the most important uses of orthopedic devices or apparatus is the support of the lumbosacral area of the back. The immobilization or immobilization of the lower The area of the body is at risk of a number of adverse effects, including tendon shrinkage and a loss of elasticity and weakening of the muscles. The orthopedic devices according to the invention provide sufficient support and enable stabilization and / or immobilization of the lower spine area without the above adverse effects occurring. This follows from the unique combination of physical properties that result in an essentially complete shutdown by the strong contoured areas of the device and at the same time a

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allow elastic support through the less strongly deformed areas of the back support, so that thereby the Movement of the body is made possible. Since the device can be molded directly on the patient, it is possible to use back supports (which cannot be produced or can only be produced with great difficulty using conventional materials), which cover relatively different and / or large areas of the back and in certain cases around the sides of the body or around or over the shoulder.

The orthopedic devices can also be used for veterinary purposes in a manner similar to that in human medicine.

The orthopedic devices can be placed in a pocket or pouch of an item of clothing that surrounds part of the body, introduced and arranged in this way. For many purposes it is desirable that the orthopedic Device is applied directly to the corresponding area of the body and surrounds it so that it sets itself. For other purposes, the orthopedic device should be provided with loops or other attachment points for straps or other fastening devices, such as Velcro fasteners, etc. be provided. These can be attached to one or both fabric layers or incorporated into these layers. In these cases, they are connected to the layer of tissue that is on the side of the orthopedic device, facing away from the patient's skin, d. H. in most cases with the outer layer of tissue. The orthopedic Devices can be designed to fix themselves or can be attached in any other way.

The orthopedic devices can be sold in the form of flat blanks that are molded by the end user and be designed. They can also be preformed, for example as preformed back supports, which are generally are adapted to the body areas of the corresponding size. These orthopedic devices have over the conventional

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Facilities have the advantage that they allow an individual final adjustment. They also differ in an advantageous manner from the conventional orthopedic devices in that they have a different type of stiffness in different directions and show elasticity behavior.

The orthopedic devices can also be used to: define the body (or part of it) very precisely for radiation treatment.

The orthopedic devices provided with an outer foam surface can be used as such or in combination with others Orthopedic devices are used to cushion or in part of the body (usually an area of bone) other way to protect.

Although the orthopedic devices are generally adequate the body shape, they can in certain cases also be shaped differently, so that the body during the use adapts to the shape of the orthopedic device, for example, you can make an insert for patients with flat feet of the orthopedic device.

The above discussion is mostly about orthopedic devices, which are attached to the body. They can also be used in facilities that are not attached to the body but come into contact with the body, such as the seat surfaces of chairs, especially orthopedic chairs, footrests, such as Arch supports, and other areas for shoes and boots. They can also be used in ski boots, where a combination Desired from relative stiffness in certain directions with elasticity in other directions of motion is.

709807/0310

Claims (33)

Claims 1J Integral, malleable, orthopedic device, characterized in that it comprises a plastic plate part which is integrated on one side with an insulating layer and on the other side with a protective layer, the plastic plate part having a thickness of at least 1.02 mm, a yield point (tensile strength at yield) of 141 kg / cm ^2, a bending strength of 211-984 kg / cm ^2, a flexural modulus of between about 0.035 * 10 and 0.49 * 10 kg / cm ^2, and a Vicat softening point of between 60 ⁰ C and 80 ⁰ C, and the insulating layer has a thickness of at least about 0.254 mm and a heat transfer coefficient of less than -4
about 2 cal / sec / cm ² / cm / ° C "10. 2. Apparatus according to claim 1, characterized in that the insulating layer consists of a plastic foam layer; and the plastic plate part has a thickness of 1.27 to 3.05 mm, a yield point of 141 to 703 kg / cm ² , an elongation (elongation when yielding) of about 3 to 30%, a flexural strength of about 211 to 984 kg / cm ² , a bending 5 5 modulus of about 0.035 10 to 0.49 χ 10 kg / cm ² , a notched Izod impact strength of 0.016 to 1.63 kpm / cm and a Rockwell hardness of 15 on the R to 55 on the D scale. 3. Apparatus according to claim 2, characterized in that the insulating layer has a heat transfer coefficient - 4 of less than about 1.6 cal / sec / cm ² / cm / ⁰ C * 10 and a foam made of a flame-resistant plastic is present as the plastic foam. 709807/0310 4. Apparatus according to claim 3, characterized in that the insulating layer has such insulating properties "that when the device is heated by supplying heat via the protective layer in such a way that the plastic ^{plate part is heated to a temperature of above about 71 °} C., the temperature of the outer surface of the insulating foam layer is at least is about 30.6 ⁰ C below the temperature of the plastic plate part. 5. The device according to claim 1, characterized in that the insulating layer has such insulating properties that when the device is heated by supplying heat via the protective layer in such an amount that the plastic plate part is heated ^{to temperatures above about 71 ° C., the temperature} the outer surface of the insulating layer is at least 13.9 ^° C. below the temperature of the plastic plate part. 6. Apparatus according to claim 1, characterized in that the insulating foam layer has a thickness of 0.25 to 6.35 mm and consists of a fire-resistant or flame-resistant plastic foam. 7. Apparatus according to claim 4, characterized in that the insulating foam layer has a thickness of 0.25 to 6.35 mm owns. 8. Apparatus according to claim 7, characterized in that 'the plastic from the polyethylene, polyurethane, polyester and / or acrylonitrile / butadiene / styrene copolymers comprising group is selected. 9. Apparatus according to claim 1, characterized in that the plastic from the group comprising polyethylene, polyurethane, polyester and acrylonitrile / butadiene / styrene copolymers' 709807/0310 is selected. 10- integral, orthopedic device, characterized in, that it comprises a middle plastic plate part, which on one side with an insulating layer and on the other side is covered with a fabric layer, both layers being connected to the plastic plate part are; the plastic sheet part has a thickness of 1.27 to 3.05 mm, a yield strength of more than about 141 kg / cm ² , a yield elongation of 3 to 30%, a flexural strength of 211 to 984 kg / cm ² and a flexural modulus of about 0.035 5 5 χ 10 to 0.48 χ 10 kg / cm ² ; the insulating layer has a thickness of about 0.25 to 6.35 mm; the other layer of fabric has a thickness of about 0.10 to 0.56 mm and protects the plastic layer; and the orthopedic device at temperatures above about 48.9 ⁰ C is malleable. 11. The device according to claim 10, characterized in that the insulating layer is in the form of a plastic foam layer present; the plastic plate part having a yield strength of 141 to 703 kg / cm ² , a notched Izod impact strength of 0.016 to 1.63 kpm / cm, a Rockwell hardness of 15 on the R scale to 55 on the D scale and a Vicat softening point of 60 to 80 ⁰ C; and the insulating foam layer has a heat transfer coefficient] shows. cients of less than about 2 cal / sec / cm ² / cm / ° C · 10 709807/0310 12. The apparatus according to claim 11, characterized in that the plastic foam is selected from the group which refractory or flame-resistant polyolefins, polyurethanes, polyesters and acrylonitrile / butadiene / styrene copolymers. 13. The device according to claim 12, characterized in that the plastic plate part has a yield point of 352 to 562 kg / cm ^a , an elongation of about 4 to 8%, a flexural strength of about 562 to 844 kg / cm ² , a flexural modulus of about 0 , 14 χ 10 to 0.35 χ 10 kg / cm ² , a notched Izod impact strength of 0.027 to 0.816 kpm / cm and a Rockwell hardness of 90 to 100 R; and the insulating fabric layer has a heat transfer coefficient -4 has cients of less than about 1.6 cal / sec / cm ² / cm / ° C x 10 6. 14. The device according to claim 13, characterized in that the protective fabric layer is a fabric selected from the high temperature stabilized nylons (polyamides), high temperature stabilized polyesters and aramids Group includes. 15. Apparatus according to claim 14, characterized in that the plastic foam is made of polyethylene. 16. The device according to claim 14, characterized in that the plastic foam consists of a polyester-polyurethane. 17. The device according to claim 14, characterized in that the plastic foam consists of a polyether-polyurethane . 709807/0310 18. Apparatus according to claim 14, characterized in that the plastic foam consists of a polyester. 19. The device according to claim 14, characterized in that the plastic foam has a thickness of about 3.18 to 6.35 mm having. 20. Orthopedic device, characterized in that it comprises a central plastic plate part, which on the one side with an insulating plastic foam and on the other hand with a high temperature stable fabric made of stabilized nylon (polyamide), stabilized polyester and mixtures thereof comprising the group is selected, is covered, the fabric layers are connected to the plastic plate part; whereby the plastic plate part has a thickness of 1.27 to 3.05 mm, a yield strength of about 141 to 703 kg / cm ² , a yield elongation of 3 to 30%, a flexural strength of 211 to 984 kg / cm ² and a flexural modulus of about 0.035 χ 10 to 0.49 χ 10 ⁵ kg / cm ² ; the insulating layer has a thickness of at least about 0.254 mm; the fabric layer has a thickness of at least about 0.10 mm owns and protects the plastic plate part; and the orthopedic device has such thermal properties that it can be deformed and shaped when the plastic plate part is heated by supplying heat via the tissue side to temperatures of above about 129 ^° C. for a period of at least about 4 1/2 minutes before the material is solidified. 21. Apparatus according to claim 20, characterized in that it as a plastic foam selected from the flame retardant material or fire-resistant polyolefins, polyurethanes, polyethers and acrylonitrile / butadiene / styrene copolymers 709807/0310 Group. 22, The apparatus of claim 21, characterized in that the insulating layer has such insulating properties that with the application of heat on the fabric side of the tempera * - tur the outer surface of the insulating foam layer is at least about 25.0 ⁰ C below the temperature of the plastic plate portion is . 23. Orthopedic device that can be molded at elevated temperatures, characterized in that it comprises a central plastic plate part, which on one side with an insulating Plastic foam layer and on the other hand with a fabric that does not appear when the device is molded Causes warping of the plastic plate texl, is covered, wherein the layers are connected to the plastic plate part; whereby the plastic plate part has a thickness of at least 1.27 mm, a yield strength of more than about 141 kg / cm ² , a flexural strength of 211 to 984 kg / cm ² and a flexural modulus of about 0.035 × 10 to 0.49 × 10 kg / cm ² has; the insulating layer is at least about 0.25 mm thick; and the fabric has a thickness of at least about 0.10 mm and serves to protect the plastic plate part. 24. Apparatus according to claim 23, characterized in that it as a plastic foam selected from the flame-resistant material or fire-resistant polyolefins, polyurethanes, polyesters and / or acrylonitrile / butadiene / styrene copolymers' comprehensive group. 25. The device according to claim 24, characterized in that the plastic ^{plate part has a yield point of 141 to kg / cm 2} , an elongation of about 3 to 30%, an Izod 709807/0310 Notched impact strength from 0.016 to 1.63 kpm / cm and a Rockwell hardness from 15 on the R scale to 55 on the D scale. 26. The device according to claim 25, characterized in that the plastic plate part has a yield point of 352 to 562 kg / cm ² , an elongation of about 4 to 8%, a flexural strength of about 562 to 844 kg / cm ² , a flexural modulus of about 0 , 14 5 5 χ 10 to 0.35 χ 10 kg / cm ² , a notched Izod impact strength of 0.027 to 0.816 kpm / cm and a Rockwell hardness of 90 to 100 R; and the insulating layer has a coefficient of heat transfer of less than about 2 cal / sec / cm ² / cm / ° C'10. 27. The device according to claim 21, characterized in that it comprises a fabric made of fibers, which are made of the high temperature stabilized Nylon fibers (polyamide fibers) and high temperature stabilized polyester fibers are selected are. 28. The device according to claim 27, characterized in that the plastic plate part consists of a thermoplastic material. 29. The device according to claim 27, characterized in that the plastic ^{plate part consists of a polyvinyl chloride compound which solidifies at a temperature between about 49 ° C and 68 0} C, and the plastic foam consists of polyethylene. 30. The device according to claim 27, characterized in that the plastic plate part consists of a polyvinyl chloride compound which ^{solidifies at a temperature of about 49 0} C to about 68 ° C, and the plastic foam consists of a polyester-polyurethane. 709807/0310 31. The device according to claim 27, characterized in that the plastic plate part consists of a polyvinyl chloride compound which ^{solidifies at a temperature of about 49 0} C to about 68 ° C, and the plastic foam consists of a polyether-polyurethane. 32. Apparatus according to claim 27, characterized in that the plastic plate part consists of a polyvinyl chloride compound which ^{solidifies at a temperature of approximately 49 °} C. to approximately 68 ^° C., and the plastic foam consists of a polyester. 33. Apparatus according to claim 27, characterized in that the plastic plate part consists of a polyvinyl chloride compound which ^{solidifies at a temperature of about 49 °} C. to about 68 ^° C., the plastic foam consisting of an acrylonitrile / butadiene / styrene copolymer. 7098Ü7 / Ü310 Le e rs e ι te