JPH04117961A - Outfit sheet and outfit - Google Patents

Abstract

PURPOSE:To obtain the outfit and the outfit sheet which can easily be manufactured, and are excellent in both fixability and movability of a joint, etc., at the time of use, and excellent in installability and durability by using a thermoplastic polyester resin provided with elasticity and flexibility in a well-balanced state, having material property to which a specific condition is limited. CONSTITUTION:The outfit is formed like a sheet by a thermoplastic polyester resin having melting point of 120 deg.C-200 deg.C of a crystal area by indication difference scanning-heating value measurement, 20-80% impact resilience rate (JIS K 6301), 25-60 surface hardness Shore D (ASTM D 2240), 200-3000kg/cm<2> bending elastic modulus (ASTM D 790), >=70kg/cm<2> tensile rupture strength (ASTM D 638), and >=70kg/cm<2> tearing strength (ASTM D 638), and formed so that it can be put on to the human body. As for this thermoplastic polyester resin, generally, aromatic crystalline polyester such as polybutyleneterephthalate, etc., is used for a hard segment, and a polymer whose glass transition point is low is used for a soft segment.

Description

[Detailed Description of the Invention] [Industrial Field of Application] The present invention is suitable for trunk braces, upper limb braces, and lower leg braces used in surgery, orthopedic surgery, rehabilitation, etc., and is particularly suitable for braces for short legs, long legs, knees, etc. The present invention relates to an orthosis and an orthosis sheet that have both fixity and movability that can be used for various purposes, and have excellent wearability and durability on the body.

[Conventional technology]

Metal, leather, and cloth have been used for a long time as materials for braces, but they have drawbacks such as being heavy, unsightly, prone to rust, and becoming unclean. However, in recent years, advances in polymer technology have led to the use of metal, leather, and cloth. Accordingly, thermoplastic resins that overcome the above-mentioned drawbacks have been widely used. Thermoplastic materials are lightweight, have a good appearance, do not rust, are stain resistant and clean, are flexible, can be shaped to some extent by heating, and are easy to manufacture. This method has the advantage that it is possible to obtain a shape that accurately matches a positive model such as plaster that has been retained from a patient.

There are 1 methods for manufacturing braces whose main material is thermoplastic resin.
．． The positive model taken from the patient was covered with a thermoplastic resin sheet that had been heated and softened in an oven.
The vacuum forming method involves sucking the air between the iJ plastic resin sheet and molding it, and the positive model taken from the patient is covered with a thermoplastic resin sheet heated and softened in an oven, and then hand tied. There is a manual molding method that involves molding the parts in close contact.

Therefore, the material used for this product has the inherent properties such as tensile properties, bending properties, tear strength, and bending resistance required when worn on the body, as well as the properties required during manufacturing, especially during heat softening. Something that is easy to handle is desired. Taking these into consideration, the thermoplastic resin used varies depending on the patient's symptoms and the site of application, but ultra-high molecular weight polyethylene, high-density polyethylene, polypropylene, etc. are mainly used.

(Problem to be solved by the invention) However, when comparing the mechanical properties of thermoplastic polyolefin resin and metal, the strength of metal is greater, and moreover, each time a kumite is used, Although it has excellent mobility, when thermoplastic polyolefin resin is used in parts such as joints, its strength is weak and it does not have sufficient fixation, and it also does not function well as a joint that requires mobility. For example, shoehorn-type short leg orthoses made of thermoplastic resin are used not only for walking but also for activities of daily living, but they require ankle dorsiflexion, such as when squatting or climbing stairs. The movement caused by this movement may cause discomfort during movement due to misalignment with the physiological joint axis, and damage caused by repeated reactions.
There are problems such as N.

If the resin sheet is made thicker to increase its strength, it will improve the stability of the ankle joints, etc., but it will not only lose the mobility of the parts corresponding to the joints, but also cause an increase in weight, causing dissatisfaction with the wearing comfort. Increased. In addition, the bulkiness of the shoes makes it impossible to wear commercially available ready-made shoes.

Therefore, in order to satisfy the conflicting requirements of fixity and mobility in a well-balanced manner, there was a need for a material that is rich in flexibility and elasticity and that is easy to manufacture.

In view of these circumstances, the present invention aims to provide an orthosis and an orthosis sheet that are easy to manufacture, have an excellent balance between fixation and mobility of joints, etc. during use, and have excellent wearability and durability. This is the purpose.

[Means to solve the problem]

In order to achieve the object stated in "-1," the present invention provides that the melting point of the crystalline region is 120 to 2 as measured by differential scanning calorimetry (DSC).
00'C, rebound modulus (JIS K 6301) is 20-80%, surface hardness Shore [) (ASTM D
2240) is 25-60, flexural modulus (ASTM D
790) is 200-3000 kg/c%, tensile strength at fracture (ASTM D 638) is 70 kg/cmi
Tear strength (ASTM D 638) of 70
A sheet for an orthosis characterized by being formed in a sheet form from a thermoplastic polyester resin having a polyester resin with a polyester resin having a melting point of 120 to 200°C in the crystalline region as measured by differential scanning calorimetry (DSC), and a rebound modulus of elasticity of 120 to 200°C. (JIS K
6301) is 20-80%, surface hardness Shore D (A
STM D 2240> is 25-60, flexural modulus (A
STM D 790) is 200-3000kg/cT1
1. Tensile breaking strength (A″STM D 638) is 70
kg/cf+ and tear strength (ASTM D
638) is made of thermoplastic polyester resin with a weight of 70 kg/cm or more and is capable of being attached to a human body.

According to the present invention, the excellent moldability, chemical properties, and mechanical properties of thermoplastic polyester resin are utilized, and the melting point, rebound modulus, surface hardness, flexural modulus, tensile breaking strength, and bow tension of the crystalline region are utilized. By setting the strength within a specific range, it is possible to obtain an orthosis and orthosis sheet that is easy to manufacture, has an excellent balance between fixation and mobility of joints, etc. during use, and has excellent wearability and durability. .

The thermoplastic polyester resin in the present invention is called a polyester thermoplastic elastomer in terms of -C, and is an (AB) n-type multi-block copolymer whose chemical structure is a hard segment made of a polyester component.

Generally, an aromatic crystalline polyester such as polybutylene terephthalate is used for the hard segment, and a polymer with a low glass transition point (Tg) is used for the soft segment. There are two types: a polyester type using a polyether such as polytetramethylene ether glycol for the soft segment I, and a polyester/polyester type using an aliphatic polyester such as polylactone for the soft segment. By selecting the type of polyester for the hard segment, the type of polyether or polyester for the soft segment, and the ratio of the hard segment to the soft segment, an elastomer with properties suitable for the purpose of the present invention can be obtained.

In order to achieve the object of the present invention, the thermoplastic polyester resin of the present invention can not only be used alone, but also be blended with various polymers to achieve a thermoplastic polyester resin of 70% or more in weight ratio. It may also be used as a composition as a main component.

For example, in order to lower the molding temperature of the orthosis sheet and adjust the fluidity of the resin at that time, it is also possible to blend a polyester thermoplastic elastomer as the main component and a polyolefin thermoplastic resin as a subsidiary component. In this case, the polyolefin-based thermoplastic resin is, for example, an acid anhydride-containing olefin-based resin obtained by copolymerizing or graph l-polymerizing an unsaturated dicarboxylic acid anhydride with a polyolefin or olefin-based polymer that has good compatibility with polyester. Polymers and the like can be used.

The melting point of the thermoplastic polyester resin according to the present invention measured by differential scanning calorimetry (DSC) is the temperature at which the thermoplastic polyester resin used in the present invention is heated and softened during molding, when a positive model retained from a patient is covered with a thermoplastic polyester sheet heated and softened in an oven. This is a guideline for settings.

The lower the melting point of the thermoplastic polyester resin, the more convenient the operation during the manufacture of orthoses is. As a result, plastic deformation or partial flow may occur when a patient bathes while wearing the orthosis or when the orthosis is disinfected, sterilized, or washed with boiling water. Additionally, if the melting point of the thermoplastic polyester resin is higher than 200"C, the heat resistance of the orthosis will improve, but workability and safety will be impaired. Take into consideration the heat resistance of the orthosis and workability during manufacturing. If so, a more desirable range is 1.50 to 180°C.

Impact modulus of thermoplastic polyester resin (JIS K2
SO3) and flexural modulus (ASTM D 790) are indicators of the ability of the orthosis to recover from deformation due to external work applied during movements such as walking. It should be determined based on the patient's disease site, degree of deformity caused by the disease, age, physical strength, etc., but 20 to 80% is necessary.
Preferably it is 30-70%. The bending modulus of thermoplastic polyester resin is 200 to 3000 kg/c+
fl is required, preferably 300-2000kg/
It is d.

The surface shore hardness D (ASTM D 2240) required for thermoplastic polyester resin is determined by the degree of correction of deformation of the affected area or the degree of local fixation, support, or load relief of the affected area, and is between 25 and 60. It is necessary, preferably 35 to 55.

Tensile strength of thermoplastic polyester resin (ASTM D6
38) and tear strength (ASTM D 624) reflect the durability of the orthosis and should be selected taking into account the patient's age, physical strength, gender, etc., but the tensile strength is 70k.
g/CTR or higher and tear strength of 70 kg/c+n or higher are required. In addition, the tensile strength is 500 kg/cff
It is practically desirable that the tear strength is 250 kg/cm or less.

The orthosis formed of the thermoplastic polyester resin of the present invention is functionally used as a short leg orthosis applied around the ankle joint as an adaptation site to the body, but is not limited thereto. Depending on the design, it can function as an upper limb orthosis or hand orthosis, and with a more rigid design, it can function as a trunk orthosis.

A heat stabilizer, an antioxidant, and a pigment agent may be added to the orthosis and orthosis sort molded from the thermoplastic resin polyester in the present invention.

Further, a fiber reinforcing agent such as glass fiber, metal fiber, or carbon fiber, or a filler reinforcing agent such as talc, lunar carbonate, or mica may be added.

Any known method may be used to mix the additives, reinforcing agents, etc. into the thermal IIJ plastic polyester resin of the present invention. For example, mix the granules of each ingredient in a ■-type blender, Henschel mixer, super mixer, or Nigu,
This may be directly molded by sea-coating or injection, or alternatively, it may be mixed in an extruder, kneader intensive mixer, etc. to form 1,000 knobs, and this may be molded. In any case, an appropriate method may be adopted depending on the resin composition ratio and the desired shape and properties of the product.

As for the manufacturing method of the orthosis sheet of the present invention, statically it is manufactured by extrusion molding using a sheet extruder. The method of manufacturing an orthosis from an orthosis sheet involves heating and softening the orthosis sheet, placing it over a positive model, etc., and sucking air between the orthosis sheet and the positive model, or applying fluid pressure from the outside of the orthosis sheet. , by applying human and mechanical power to form them into close contact. Furthermore, as a method for forming the orthosis, the orthosis sheet extruded by a sheet extruder is cooled.
The material may be subjected to various molding processes such as blow molding, press molding, and vacuum forming, or may be directly molded using a molding method such as injection molding. In this case, it takes a ready-made shape that has been given a certain degree of shape as a brace.
It is also possible to modify mucosal fit when applied to a patient.

The thickness of the orthosis sheet and the orthosis is not particularly limited, but 1 to 5 mm, preferably 2 to 4 mm is practically appropriate.

EXAMPLES Hereinafter, the present invention will be explained in more detail with reference to Examples, but the present invention is not limited thereto.

[Example 1] Thermoplastic polyester resin (melting point of crystalline region by DSC: 172°C 1 Impact modulus (JJS K 630J) 7
8%, surface hardness Shore D (ASTM D 2240)
38, Flexural modulus (ASTM D 790) 520
kg/cm, tensile breaking strength (ASTM D638) 2
30 kg/cf, tear strength (ASTM D 63
8) Belprene P-401 as 100kg/cm)
1 (manufactured by Toyobo Co., Ltd.) with a die width of 600ff1
Extruded with m sea j extruder, 500 mm
A sheet measuring 500 mm x 3+ nm thick was obtained.

This sheet was heated in an oven at 180°C for 110 minutes to soften it, and then molded by hand into a plaster-positive model for short leg braces. When the sheet was removed from the oven, there was little dripping, and it was relatively easy to handle. .5 ram
Orthoses with thicknesses within the range of 100 to 100% were obtained with good reproducibility.

When this orthosis was modified and I-rimmed and applied to a patient with mild equinus varus foot, the dragging of the foot tip was improved by proper fixation, the gait was stabilized, and elastic mobility was achieved. This made it easier to crouch down. Also,
He was able to wear a brace and wear commercially available shoes, allowing him to go out.

[Example 2] Thermoplastic polyester resin (melting point of crystalline region by DSC: 160' C1 rebound modulus (JIS K 6301)
78%, surface hardness Shore D (ASTM D 224)
0) 29, Flexural modulus (ASTM D 790) 1
．． 50kg/aIfl, tensile strength at break (ASTM D6
38) 1.50 kg/c+fl, tear strength (AS
TM D 638) 73 kg/cm) was extruded using a sheet extruder with a width of 600 mm to extrude a chimbu of Pervrene P-30B (manufactured by Toyobo Co., Ltd.) to give a weight of 50 kg/cm.
A sheet of 0 mm x 500 mm x 3 mm thickness was obtained.

When this sheet was heated in an oven at 170°C for 110 minutes to soften it and molded by vacuum forming into a pediatric plaster-positive model for short leg orthoses, orthoses with a thickness in the range of 2 to 2.5 mm were obtained with good reproducibility. It was done.

When this pediatric orthosis was trimmed and worn on a patient with mild equinus varus foot, it was found to be more flexible than the orthosis of Example 1, so it could be easily used for children.

〔Effect of the invention〕

As is clear from the above description, according to the present invention, production is easy by using a thermoplastic polyester resin that has physical properties under specific conditions and has a well-balanced combination of elasticity and flexibility. Furthermore, it is possible to provide an orthosis and an orthosis sheet that have contradictory required performances of fixation and mobility.

Claims (2)

[Claims] (1), the melting point of the crystalline region by differential scanning calorimetry (DSC) is 120 to 200°C, and the rebound modulus (JISK63
01) is 20-80%, surface hardness Shore D (ASTMD
2240) is 25-60, flexural modulus (ASTMD79)
0) is 200 to 3000 kg/cm^2, the tensile strength at break (ASTMD638) is 70 kg/cm^2 or more, and the tear strength (ASTMD638) is 70 kg/cm or more. An orthosis sheet featuring: (2), the melting point of the crystalline region by differential scanning calorimetry (DSC) is 120 to 200°C, and the rebound modulus (JISK63
01) is 20-80%, surface hardness Shore D (ASTMD
2240) is 25-60, flexural modulus (ASTMD79)
0) is 200 to 3000 kg/cm^2, the tensile strength at break (ASTMD638) is 70 kg/cm^2 or more, and the tear strength (ASTMD638) is 70 kg/cm or more. An orthosis characterized by: