KR100319261B1 - Orthopedic splint and brace - Google Patents

Abstract

The present invention relates to an orthopedic splint and an auxiliary device, wherein the orthopedic splint and an oral device of the present invention is impregnated with a prepolymer impregnated with a support having a thickness of 2 to 15 mm and a polyurethane prepolymer composition of 200 to 1000 wt% based on the weight of the support. layer; And first and second protective layers each having a thickness of 0.5 to 3 mm and positioned at upper and lower portions of the impregnation layer, wherein the support and the protective layer are made of a nonwoven fabric or a knitted fabric.

Description

Orthopedic splint and braces

The present invention relates to an orthopedic splint and orthosis, and more particularly, does not contain harmful components such as glass fibers, is hygienic, has good X-ray permeability, is easy to perform, and has excellent adhesiveness with the adherend. It relates to an orthopedic splint and orthosis that is convenient to apply to the affected body part.

Conventional gypsum cast used in the treatment of fractures, such as in orthopedic surgery, there is a problem that the procedure is inconvenient and weighty as well as poor X-ray permeability. Therefore, in recent years, attention has been increasing about the orthopedic splint and the auxiliary machine which coated curable resin on the support body, such as a glass fiber fabric.

Most currently used orthopedic splints and auxiliaries are manufactured by coating and / or impregnating a hydraulic polyurethane resin on a flexible support such as a glass fiber fabric. However, the glass fiber support may cause itching or acute percutaneous toxicity in patients due to the generation of glass fiber dust when cutting for the procedure, and it is not completely incinerated after use, causing environmental pollution and difficult disposal. There is a problem.

In addition, orthopedic splints and braces require a certain strength and rigidity. When using a fabric support, multiple fabrics must be laminated to meet the above requirements. Therefore, there is a problem in that a skilled technique is required for the procedure because it is difficult to be in close contact with the body in a severely curved area such as an elbow or a heel. As such, when the orthopedic splint or brace hardens in a state in which it is not in close contact with the body, the appearance may not be beautiful, and the body may not be sufficiently fixed, thereby reducing stability and achieving the desired therapeutic purpose.

Therefore, the technical problem to be achieved by the present invention is that it does not contain harmful components such as glass fiber, is hygienic and has good X-ray permeability, is easy to perform, and is easy to dispose of after use, and furthermore, It is to provide a good orthopedic splint and orthosis.

1 is an enlarged cross-sectional view showing the structure of an orthopedic splint or brace according to the present invention.

<Description of main parts of drawing>

10 ... impregnation layer

11, 12 ... protective layer

In order to achieve the above object, the present invention is a prepolymer impregnated layer impregnated with a polyurethane prepolymer composition of 200 to 1000% by weight based on the support weight, 2 to 15mm thick support; And first and second protective layers each having a thickness of 0.5 to 3 mm and positioned at upper and lower portions of the impregnation layer, wherein the support and protective layer are formed of nonwoven or knitted fabric. to provide.

According to one embodiment of the invention, the support is made of a polyester knitted fabric having a density of 0.05 to 0.6 g / cm ³ , the protective layer may be made of a nonwoven fabric of a density of 0.05 to 0.3 g / cm ³ .

The polyester knitted fabric is made of DTY, the support is preferably a single layer or double layer structure.

According to another embodiment of the present invention, the support and the protective layer may be made of a nonwoven fabric having a density of 0.05 to 0.3 g / cm ³ .

The nonwoven fabric is preferably made of one or more short fibers selected from the group consisting of polyethylene short fibers, polypropylene short fibers, and polyester short fibers.

The polyurethane prepolymer composition comprises 50 to 65% by weight of 4,4'-diphenylmethane diisocyanate, 3 to 10% by weight of 2,4-diphenylmethane diisocyanate, 25 to 30% by weight, based on the total weight of the composition Propylene glycol, 6-8 wt% ethylene glycol and propylene glycol random copolymer, 0.5-2 wt% dimorpholino diethyl ether as hydrocuring catalyst, 0.1-2 wt% polyalkyleneoxydimethylsiloxane as antifoaming agent and It is preferable to obtain by making 0.01-1 weight% phosphoric acid react as a stabilizer.

The polyurethane prepolymer composition may further include dibutyl phthalate as a plasticizer, 0.5 to 2% by weight based on the total weight of the composition.

The polyurethane prepolymer composition may further comprise 10 to 20% by weight of ceramic powder.

Hereinafter, with reference to the accompanying drawings will be described in more detail the orthopedic splint and brace of the present invention.

As shown in FIG. 1, the orthopedic splint and auxiliary device according to the present invention are impregnated with a hydrocurable polyurethane prepolymer on a support such as a nonwoven fabric made of polyethylene short fiber, polypropylene short fiber or polyester short fiber, or a knitted fabric made of DTY yarn. The prepolymer impregnated layer 10 is surrounded by the protective layers 11 and 12 made of the same or different materials as the support.

The density of the support suitable for use in the present invention is preferably 0.05 to 0.3 g / cm ³ for nonwoven fabrics, and 0.05 to 0.6 g / cm ³ for polyester knit fabrics. This is because if the density is less than the above range, sufficient strength and rigidity cannot be obtained, and if it exceeds the above range, there is a problem that it is too hard to be applied to the curved portion.

The thickness of the nonwoven fabric may vary depending on the part of the body to which the orthopedic splint or brace is to be applied. In general, the impregnation layer is preferably 2 to 15 mm, and the protective layer is 0.5 to 3 mm. If the thickness of the nonwoven fabric is too thin, a sufficient amount of resin cannot be impregnated, and if it is too thick, the adhesion to the applied body part is lowered.

Referring to the manufacturing process of the nonwoven fabric preferred for use in the present invention as an example. A web is produced by carding a collection of short fibers such as polyethylene short fibers, polypropylene short fibers or polyester short fibers. The fabricated web is preneedling at low speed to form a loose nonwoven fabric. In the pre-needling process, the needles of the needling machine penetrate the web and entangle the short fibers constituting the web with each other to form a loose nonwoven fabric. Subsequently, if necessary, the loose structure of the nonwoven fabric is needled at a higher speed so that the short fibers of the loose structure of the nonwoven fabric are more entangled, thereby making the structure of the nonwoven fabric compact.

It is preferable that the polyester knitted fabric is made of DTY yarn having a light and coarse structure because it is excellent in adhesion to a curved body part because a sufficient amount of resin can be impregnated into a single layer structure.

The polyurethane prepolymer composition used in the present invention is not particularly limited, but a preferred composition may be, for example, 50 to 65% by weight of 4,4'-diphenylmethane diisocyanate, 3 to 10% by weight based on the total weight of the composition. 2,4-diphenylmethane diisocyanate, 25-30 wt% polypropylene glycol, 6-8 wt% ethylene glycol and propylene glycol random copolymer, 0.5-2 wt% dimorpholinodiethyl as hydrocuring catalyst Obtained by reacting 0.1 to 2% by weight of polyalkyleneoxydimethylsiloxane as an ether, an antifoaming agent and 0.01 to 1% by weight of phosphoric acid as a stabilizer, and in some cases, 0.5 to 2% by weight in order to control the viscosity of the resin composition. It may further include a plasticizer.

The polyurethane prepolymer is preferably obtained by reacting a mixture of polyisocyanate and polyether polyol at a temperature of 30 to 120 ° C. for 1 to 10 hours, and the reaction ratio of the polyisocyanate and polyether polyol is produced after the reaction. It is preferable to select the urethane prepolymer so that it contains 12-16 mol% of unreacted isocyanate groups.

These unreacted isocyanate groups react with water to generate carbon dioxide while reacting with water to cure the polyurethane prepolymers.

-NCO + HOH + OCN- → [-NH-CO-O-OC-NH-] → -NHCONH- + CO ₂ ↑

When the content of the unreacted isocyanate group contained in the polyurethane prepolymer is less than 12 mol%, the viscosity of the reactant is high during hydrocuring reaction, resulting in poor workability, and when it exceeds 16 mol%, the adhesive strength of the splint or auxiliary group is decreased and the final This is because the cured product may be broken.

Examples of the polyether polyol suitable for use in the present invention include polyethylene glycol, polypropylene glycol, polytetramethylene glycol, and the like, and may be used alone or in combination of two or more as necessary.

Specifically, for example, it is preferable that the polypropylene glycol has a weight average molecular weight of 2000 and 450 in a 1: 1 to 1: 2 weight ratio.

In addition, ethylene glycol and propylene glycol random copolymers may also be used. The weight average molecular weight is 2000, and copolymerization of ethylene glycol in a ratio of 1 to 15% by weight is preferable for increasing affinity with water.

The polyisocyanate reacting with the polyether polyol may be various kinds of polyisocyanates known in the art. Specifically, for example, aromatic polyisocyanates such as 4,4'-diphenylmethane diisocyanate, 2,4-diphenylmethane diisocyanate, 1,4-phenylene diisocyanate and aliphatic polyisocyanates such as hexamethylene diisocyanate Etc. can be mentioned.

The said polyisocyanate can also be used individually or in combination of 2 or more types as needed, Especially preferable are 4,4'- diphenylmethane diisocyanate and 2, 4- diphenylmethane diisocyanate.

The hydrocuring catalyst plays a role of promoting the curing reaction of the polyurethane prepolymer when wetted in water for the treatment of orthopedic splints and auxiliary groups. This can be used.

As the amine compound catalyst, diethylene triamine, hexamethylene diamine, and the like, as the morpholine compound catalyst, dimorpholino diethyl ether, bis (2,6-dimethylmorpholino) diethyl ether, bis [2- (4 -Morpholino) propyl] ether, bis [2- {4- (2,6-dimethylmorpholino)} propyl] ether, etc. are mentioned, Especially, dimorpholino diethyl ether is the most preferable. In addition, a metal catalyst such as dibutyltin dilaurate may be used.

The content of the hydrocuring catalyst in the polyurethane prepolymer composition is preferably about 0.5 to 2% by weight based on the total weight of the prepolymer composition.

The stabilizer serves to prevent premature curing reaction of the polyurethane prepolymer during storage in the form of splint and auxiliary groups according to the invention substantially in the absence of water, i.e. before treatment, phosphoric acid (H ₃ PO ₄ Is preferred. The amount of stabilizer is preferably 0.01 to 1% by weight based on the total weight of the prepolymer composition. If the content is less than 0.01% by weight can not be obtained a stabilizing effect, when the content exceeds 1% by weight there is a problem that the water curing reaction time of the polyurethane prepolymer is excessively long.

The polyurethane prepolymer composition comprises 0.1 to 2% by weight of an antifoaming agent, for example polyalkyleneoxydimethylsiloxane copolymer. Antifoaming agent is used for the purpose of minimizing foaming by carbon dioxide generated by the reaction of isocyanate group and water of polyurethane prepolymer.

The polyurethane prepolymer composition may optionally further comprise 0.5 to 2% by weight of a plasticizer, for example dibutyl phthalate, for adjusting the viscosity of the prepolymer composition.

The polyurethane prepolymer composition can be prepared by uniformly blending the components, namely polyurethane prepolymer, hydrocuring catalyst, stabilizer, antifoaming agent, and plasticizer. The polyurethane prepolymer composition may also include other known additives, such as antioxidants, ultraviolet absorbers, colorants such as dyes or pigments, fillers such as calcium carbonate, titanium dioxide, carbon black, clay. In particular, when containing 10 to 20% by weight of the ceramic powder based on the total weight of the composition, far infrared rays, which are beneficial to the human body, may be released, thereby increasing the therapeutic effect.

The strength and rigidity of the cured splint and brace are determined by the amount of polyurethane prepolymer composition impregnated in the nonwoven. Depending on the part of the body to be used for orthopedic splints and orthosis, it is generally preferred to be 2 to 10 times the weight of the support. If the weight of the polyurethane prepolymer composition is less than 2 times, sufficient strength and rigidity cannot be obtained. If the weight of the polyurethane prepolymer composition is greater than 10 times, the splint or orthosis is too heavy and excessive heat of curing may occur, causing the patient to be burned.

Next, a process for producing an impregnation layer impregnated with a polyurethane prepolymer composition on a nonwoven fabric or a knitted fabric will be described. After cutting into the shape of the body portion to be applied to the nonwoven or knitted fabric, it is immersed in a barrel containing the polyurethane prepolymer composition according to the present invention for 5 to 10 seconds and then taken out. The amount of polyurethane prepolymer impregnated on the support is then adjusted to suit the application (depending on the part of the body applied) by removing excess prepolymer composition using a squeezer roller.

A protective layer nonwoven fabric is padded on the upper and lower surfaces of the impregnated layer prepared as above, and the edges (reference numeral 15 of FIG. 1) of the protective layer nonwoven fabric which are in contact with each other are bonded using an adhesive, a double-sided tape, or a sewing thread. The resultant orthopedic splint or brace may be stored in a container, for example an airtight container such as an aluminum bag, to block contact with moisture containing air.

Next, a brief description will be given of a method for orthopedic splint or brace in accordance with the present invention.

Remove the excess water by squeezing two or three times after removing the orthopedic splint or brace of the appropriate size from the container and immersing it in water at room temperature for about 5 to 10 seconds. Properly place the splint or brace in which excess water has been removed. After proper trimming, the splints or braces are wound with fastening means such as elastic bandages to hold them against the body.

On the other hand, orthopedic splint or brace according to the present invention is removed from the container for blocking the air and placed in accordance with the site to be treated and then cured by the procedure, in addition to hardening to a shape suitable for each part of the body in advance to a three-dimensional splint In the prepared state can also be used to trim to the size of the body part of the patient. According to the latter method, it is possible to save the time required for the curing reaction of the polyurethane prepolymer, so there is an advantage that the procedure can be completed quickly. In addition, orthopedic splints and braces according to the present invention can also be used as lumbar and spinal braces, women's bra cups, and sports aso.

Hereinafter, the present invention will be described in more detail with reference to Examples, which are merely exemplary and the present invention is not limited thereto.

Example 1

Hydrocurable polyurethane prepolymer compositions were prepared by the following method. As the diisocyanate component, 17.8 parts by weight of 4,4'-diphenylmethane diisocyanate (D-chemical, I-125MK), 4,4'-diphenylmethane diisocyanate and 2,4-diphenylmethane diisocyanate (49 To 55% by weight) of 10.8 parts by weight of a mixture (MI, BASF Korea) and 35.8 parts by weight of 4,4'-diphenylmethane diisocyanate (143LK, Dow Chemical Co., Ltd.); As the polyol component, 11.3 parts by weight of polypropylene glycol having an average molecular weight of 2,000 (H-2000, un-emulsified), 15.3 parts by weight of polypropylene glycol having an average molecular weight of 450 (H-450, unoiled), polyethylene and polypropylene random copolymer ( 7.9 parts by weight of DR-802, Polyol Korea Co., Ltd.) were added to the reactor.

The mixture was stirred for 30 to 40 minutes, and then 0.02 parts by weight of phosphoric acid was added as a stabilizer. Subsequently, the mixture was reacted at 60 ° C. for 1 hour, and then heated to 80 to 85 ° C. for about 3 hours. Subsequently, 0.3 parts by weight of a polyalkyleneoxydimethylsiloxane copolymer (SAG-1000, OSI Specialities, Inc.) as an antifoaming agent, and 0.9 parts by weight of dimorpholino diethyl ether (US Nitroil, Inc.) were added as a hydrocuring catalyst. The reaction was further performed for 1 hour.

The viscosity of the polyurethane prepolymer composition thus obtained was 12,000 cps as measured by rotating a No. 4 rotor at a speed of 12 using a rotational viscometer at 20 ° C.

Using the polyurethane prepolymer composition prepared in this way, an orthopedic splint was prepared according to the following method. First, a 6 mm thick polyester knitted fabric (DTY 300D 96F, SK Chemicals) was immersed in a cylinder containing the polyurethane prepolymer composition, and then adjusted using a compression roller to impregnate the composition to about 500 g per 100 g of the knitted fabric. As a protective layer, a 3 mm nonwoven fabric of narrow fibers was wrapped and sealed with an adhesive to complete an orthopedic splint.

The orthopedic splint was immersed in water at 21-24 ° C. 3-4 times and then drained if water was sufficiently absorbed. Subsequently, the orthopedic splint was placed on a good absorbent towel to press and remove the remaining water. Subsequently, the orthopedic splint is properly positioned on the lower foil wound or not wound with an elastic bandage, fixed within 3 to 4 minutes to the shape of the patient's lower arm, and the trimmed splint is properly trimmed, and then Splints were properly fixed when the resin was cured by wrapping elastic bandages around the wood and habak. The hardening rate of the splint was 4 min / 20 ℃, and it adhered well to the elbow without grounding and was well ventilated. From 20 out of 25 patients, 20 patients were satisfied with the fit and appearance.

Example 2

An orthopedic wood was prepared in the same manner as in Example 1 except that a 6 mm nonwoven fabric of narrow fibers was used as a support, and satisfactory results were also obtained.

Example 3-4

The same procedure as in Examples 1 and 2 was conducted except that 0.9 part by weight of dibutyl phthalate was added as a plasticizer. Again satisfactory results were obtained.

Example 5-6

Except for adding 15% of the ceramic powder of Daejong Industrial Co., Ltd. based on the total weight of the composition, the orthopedic splint was manufactured in the same manner as in Examples 1 and 2, and then the far-infrared emissivity was measured by the Far-Infrared Research Institute. appear.

As described above, the orthopedic splint and the auxiliary device according to the present invention do not contain harmful components such as glass fibers, are hygienic and have good X-ray permeability, are easy to be used, and are easy to be disposed of after use. In addition, the orthopedic splint according to the present invention is made of a nonwoven fabric or knitted fabric having excellent adhesion and form stability because the support of the curable resin is hardened in a state in which it is hardly adhered to the treatment site without wrinkles or folds, so that it is applied to a severe bending part. This is possible. Therefore, even without skilled skills, it can be easily performed.

Claims (8)

A prepolymer impregnating layer in which a support having a thickness of 2 to 15 mm is impregnated with 200 to 1000 wt% of the polyurethane prepolymer composition based on the weight of the support; And first and second protective layers each having a thickness of 0.5 to 3 mm and positioned at upper and lower portions of the impregnation layer, wherein the support and the protective layer are made of a nonwoven fabric or a knitted fabric. According to claim 1, wherein the support is made of a polyester knitted fabric having a density of 0.05 to 0.6 g / cm ³ , the protective layer is an orthopedic splint and auxiliary device, characterized in that the non-woven fabric of a density of 0.05 to 0.3 g / cm ³ . 3. The orthopedic splint and brace according to claim 2, wherein the polyester knitted fabric is made of DTY yarn, and the support has a single layer or double layer structure. 2. The orthopedic splint and aid according to claim 1, wherein the support and the protective layer are made of a nonwoven fabric having a density of 0.05 to 0.3 g / cm ³ . 2. The orthopedic splint and aid according to claim 1, wherein the nonwoven fabric is made of at least one short fiber selected from the group consisting of short polyethylene polyethylene, short polypropylene fiber and short polyester fiber. The method of claim 1, wherein the polyurethane prepolymer composition is 50 to 65% by weight of 4,4'- diphenylmethane diisocyanate, 3 to 10% by weight of 2,4-diphenylmethane diisocyanate, 25 to 30 weight percent polypropylene glycol, 6 to 8 weight percent ethylene glycol and propylene glycol random copolymer, 0.5 to 2 weight percent dimorpholino diethyl ether as hydrocuring catalyst, 0.1 to 2 weight percent poly as antifoaming agent An orthopedic splint and an auxiliary device, characterized in that obtained by reacting 0.01 to 1% by weight of phosphoric acid as alkyleneoxydimethylsiloxane and a stabilizer. 7. The orthopedic splint and aid according to claim 6, wherein the polyurethane prepolymer composition further comprises 0.5 to 2% by weight of dibutyl phthalate as a plasticizer, based on the total weight of the composition. 7. The orthopedic splint and aid according to claim 6, wherein the polyurethane prepolymer composition further comprises 10 to 20% by weight of ceramic powder.