WO2016006848A1 - Thermoplastic cast with excellent transformability and rigidity. - Google Patents

Thermoplastic cast with excellent transformability and rigidity. Download PDF

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Publication number
WO2016006848A1
WO2016006848A1 PCT/KR2015/006516 KR2015006516W WO2016006848A1 WO 2016006848 A1 WO2016006848 A1 WO 2016006848A1 KR 2015006516 W KR2015006516 W KR 2015006516W WO 2016006848 A1 WO2016006848 A1 WO 2016006848A1
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WO
WIPO (PCT)
Prior art keywords
cast
polycaprolactone
strength
composite
polycaprolactone composite
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PCT/KR2015/006516
Other languages
French (fr)
Korean (ko)
Inventor
박종칠
Original Assignee
주식회사 우리소재
박종칠
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Application filed by 주식회사 우리소재, 박종칠 filed Critical 주식회사 우리소재
Publication of WO2016006848A1 publication Critical patent/WO2016006848A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/01Orthopaedic devices, e.g. splints, casts or braces
    • A61F5/04Devices for stretching or reducing fractured limbs; Devices for distractions; Splints
    • A61F5/05Devices for stretching or reducing fractured limbs; Devices for distractions; Splints for immobilising
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/04Plaster of Paris bandages; Other stiffening bandages
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/07Stiffening bandages
    • A61L15/08Stiffening bandages containing inorganic materials, e.g. plaster of Paris
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/07Stiffening bandages
    • A61L15/12Stiffening bandages containing macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/07Stiffening bandages
    • A61L15/12Stiffening bandages containing macromolecular materials
    • A61L15/125Mixtures of macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/01Orthopaedic devices, e.g. splints, casts or braces
    • A61F5/0102Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations
    • A61F2005/0181Protectors for articulations
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/01Orthopaedic devices, e.g. splints, casts or braces
    • A61F2005/0197Orthopaedic devices, e.g. splints, casts or braces with spring means

Definitions

  • the present invention relates to a thermoplastic cast having excellent deformability and rigidity. More specifically, the present invention relates to a thermoplastic cast having a deformability and rigidity. A thermoplastic cast having excellent rigidity.
  • casts are generally installed on the affected areas using bandages and plasters, but these plasters are not only heavy but also cannot be remolded once solidified and deteriorated when exposed to moisture. It is difficult for a patient to bathe or shower because it is damaged or damaged, and air is not easily passed to the part where the cast is installed.
  • a cast disclosed in US Patent No. 6,673,029 may be used.
  • the cast is made of a mesh shape having a relatively large size of the eye 120, in which the material forming the mesh shape has sufficient strength to firmly support and protect the body part.
  • the resin-impregnated fiberglass fiber 110 is laminated in 6-12 layers to form a plate shape, and then the plate-shaped material is cut to form an hexagonal mesh array of eyes.
  • Reticular is not only difficult to laminate the resin impregnated fiberglass fiber 110 in multiple layers, but also as described above
  • the surface of the fiber layer is not smooth due to the unevenness of the impregnation during the resin impregnation process, so that the cast 100 made of such a smooth surface is worn. Thereby, there is a disadvantage that the patient may feel uncomfortable.
  • the patent In order to manufacture the cast 100 in the form of a reticular body, the patent first uses a fiberglass fiber 110 to make a cloth, and then cuts a diamond shape from the cloth to make an eye, thereby making the fiberglass fiber 110 ) Can be loosened, and in this case, the strength of the cast 100 may be weakened, and when the resin is impregnated in the loosened all-parts, this part becomes sharp and may irritate the user's skin.
  • the cast 100 is manufactured by impregnating with a water-curable resin, contact with water or moisture should be prevented in the manufacturing process, and thus, when the cast is manufactured, productivity is low because the cast 100 should be made in a closed space from which moisture or moisture is removed. Since the contact with moisture must be blocked even after manufacture, the manufactured cast must be sealed and stored.Therefore, there is a problem in manufacturing management and cost, and once it is cured, it cannot be used again. Even if it is necessary to modify 100, there is a problem that it is difficult to modify and reuse the cast 100.
  • thermoplastic network In order to solve the problems of the above water-curable cast, a cast made of a thermoplastic network has been developed, and one example thereof includes the thermoplastic cast disclosed in US Patent Application Publication No. 2008-0154164.
  • the cast disclosed in U.S. Patent Application Publication No. 2008-0154164 discloses a plurality of casts therebetween by forming the sprint member 210 of the cast 200 into a mesh having an approximately diamond-shaped opening, as shown in FIGS. 2A and 2B.
  • Four rhombus-shaped passages 220 are formed, wherein the material of the sprint member 210 is a polycaprolactone composite material that can be formed at a low temperature so as to have sufficient strength to firmly support and protect a body part.
  • a material in which additives such as lignocellulosic is mixed is used for the formed base material, and the 'extension' in the longitudinal direction of the side is limited by such a structure and the used material, but it is easily stretched in a direction parallel to the directions of axis 1 and axis 3.
  • the shape of the rhombus formed on the network according to the appearance of the body can be easily deformed (hereinafter, referred to as 'deformation'). It is distinguished from 'height', which means that the length of the mutation increases.)
  • the cast disclosed in the patent document is easy to deform, so that the procedure to the patient's body is relatively easy, but the entire cross section of the mesh-shaped sprint member 210 is formed by a polycaprolactone composite material to which lignocellulose is added. Therefore, the strength is relatively weak, and because of the softness of the material is not limited to the elongation in the longitudinal direction of the side is increased to some extent, in this case the thickness of the side is reduced, thereby weakening the cast strength There are disadvantages.
  • an underlying padding or skin protector having a relatively small eye size is installed around the affected part to protect the skin of the patient.
  • plasticity is maintained by heating a web-shaped cast having a relatively large eye size on the upper part of the pad, it is formed by surrounding the affected part and fixing it with a clip or the like.
  • the lower pad is installed below the cast, If the ventilation is not smooth, and the lower pad gets wet due to the shower, the user may feel uncomfortable because moisture may remain on the lower pad for a long time.
  • the lower pad when the lower pad is additionally installed in the lower part of the cast as described above, the lower pad may not be freely flown due to the contact between the upper cast and the lower pad, which may be uncomfortable.
  • the lower pad should be replaced occasionally because it is shorter than the period. In this case, it is difficult and inconvenient to replace the lower pad by first melting the cast and then replacing the lower pad and forming the cast again.
  • thermoplastic material is an orthopedic fixation material (cast) using the resin composition disclosed in Korean Patent Application Publication No. 10-2005-74734.
  • the cast disclosed in this document includes polycaprolactone and thermoplastic polyurethane. And it is manufactured by injection molding using a material in which the filler is mixed at a specific ratio, the cast can be excessively elongated during the procedure because the cast is mainly made of polycaprolactone and polyurethane, which is relatively weak in strength. Not only can it be deformed after the procedure, but because the cast consists only of a polycaprolactone composite layer, the cast can be stretched excessively during the procedure, and the surface of the cast is hard to the patient's skin. Contact may cause discomfort.
  • the stretch in the longitudinal direction of the side can be limited, so that the strength of the cast can be maintained and the rhombus-shaped eye can be easily deformed according to the shape of the patient's body part. It is necessary to develop a cast made of a material which can be easily processed and prevents excessive deformation and can be mass-produced.
  • the present invention has been devised to solve the problems of the cast of the mesh shape made of a conventional thermoplastic material as described above, having sufficient strength and excellent deformability, and does not feel inconvenience for the user when worn, mass production
  • the aim is to provide a thermoplastic cast with good deformability and rigidity.
  • An object of the present invention as described above is made of a polycaprolactone composite cast, the structure having a mesh shape by repeatedly opening the polygonal shape;
  • the melting point of the polycaprolactone composite material constituting the structure, the outer surface of the structure consists of a rubber material or silicone having a Shore D hardness in the range of 2 ⁇ 35 range Is achieved.
  • the mesh-like structure is molded by injection molding or compression molding (press), it is preferable that the outer skin attached to the outer peripheral surface of the structure is molded by insert injection in which the injection molding is made with the structure installed in the mold.
  • the polycaprolactone composite constituting the structure preferably includes polycaprolactone having a molecular weight in the range of 20,000 to 80,000.
  • the polycaprolactone composite is preferably one or more synthetic resins of polyethylene, polypropylene, polybutene, polyurethane, and polyethylene phthalate by blending.
  • the polycaprolactone composite material is mixed with strength reinforcement made of glass fiber or carbon fiber, and the strength reinforcement material is more preferably mixed with 10 to 60% by weight based on the caprolactone composite.
  • nucleating agents of calcium carbonate, talc, sodium benzoate, MBS, DMBS and DEBS to the polycaprolactone composite.
  • the present invention improves breathability because the cast has a net shape.
  • the present invention is made of a polycaprolactone composite with reinforced structure, the soft outer shell wraps the structure to serve as a reinforcement and deformation limiting element for the structure to facilitate the cast procedure to the affected area Adequate strength is ensured.
  • the material for forming the structure and the shell is made of a material suitable for injection molding, mass production by double injection is possible.
  • the present invention does not feel uncomfortable even when the cast (surface) is in contact with the skin of the patient because the outer shell made of a relatively soft material surrounds the outer peripheral surface of the rigid structure.
  • 1A and 1B show an example of a conventional cast
  • thermoplastic cast according to the present invention is a cross-sectional view showing the cross-sectional shape of the thermoplastic cast according to the present invention.
  • thermoplastic cast according to the present invention.
  • the present invention relates to a composition of a thermoplastic cast used to wrap around, fix or correct a fracture site of a patient, the cast according to the present invention having a structure 10 and an outer circumferential surface of the structure 10 as shown in FIG. It consists of a shell 20 surrounding the structure, wherein the structure 10 is manufactured by injection molding or compression molding, the shell 20 is manufactured by injection molding.
  • Structure 10 has a net shape by the regular opening of the polygonal shape, wherein the cross section of the side forming the net shape has a rectangular shape that is relatively higher in height than the width to ensure sufficient rigidity against external force or impact Molded to have such a structure 10 is made of a polycaprolactone composite based on polycaprolactone (PCL, polycaprolactone).
  • PCL polycaprolactone
  • Polycaprolactone is used as a main material of the polycaprolactone composite constituting the structure 10.
  • the polycaprolactone used in the present invention is a kind of polyester produced by ring-opening polymerization of caprolactone, and is a crystalline polymer. It has a low melting point of ⁇ 80 ° C.
  • the polycaprolactone (PCL) used in the present invention has a molecular weight in the range of 20,000 to 80,000, which is the mechanical properties (impact strength) as shown in Table 1 below when the molecular weight of polycaprolactone is less than 20,000 Since it is low, it cannot be expected to serve as a structure, and therefore, it is preferable to use one having a large molecular weight. However, when the molecular weight is larger than 80,000, the flexural strength and flowability become worse, which is unsuitable as a material for injection molding. will be.
  • the melting point of the polycaprolactone under the above conditions is in the range of about 50 ⁇ 80 °C, whereby the cast on the affected area can be easily performed.
  • the mechanical properties in particular, the tensile strength is so low that it is difficult to use as a cast for supporting the affected part, and accordingly, in the present invention, mechanical properties such as tensile strength
  • a strength reinforcing material is added to the main material (polycaprolactone) to be improved, and as such strength reinforcing material, fiber reinforced glass fiber or carbon fiber is used.
  • the nucleating agent is added to the structure 10, and the nucleating agent raises the crystallization temperature of the crystalline polymer and accelerates the growth rate of the crystal without affecting the melting temperature.
  • carbonate DMBS (Di-p-methylbenzylidene sorbitol), DEBS (N, N'-Diphenyl-2,2'-Diselenodibenzoamide Di-p-ethylbenzylidene sorbitol), MBS (monobenzylidene sorbitol), talc (talc), sodium benzoate (Sodium Benzoate) and the like can be used.
  • the cast When the cast is applied to the affected part of the patient, the cast is first put in hot water or heated by a heater to soften the cast, and then the cast is deformed according to the appearance of the body.
  • the cast In the case of manufacturing the cast using only (10), not only the structure 10 may be excessively stretched, but may also be uncomfortable when the surface of the structure 10 is hard to come into contact with the patient's skin.
  • the cast of the present invention has a structure in which the outer shell 20 is molded and attached to the outer circumferential surface of the structure 10, and the outer shell 20 wraps the molten structure 10 to prevent excessive elongation of the structure to form a net shape.
  • a cushioning material that maintains the shape of the rectangular shape as it is, and at the same time prevents the thickness from being thinned, thereby reducing the strength, and also prevents the hard surface of the structure 10 from directly contacting the patient's skin. Function as.
  • the outer shell 20 In order for the outer shell 20 to have a function as described above, that is, the structure 10 is excessively elongated and consequently thin, resulting in a decrease in strength, the outer shell 20 must have an appropriate thickness and an appropriate strength.
  • the outer shell 20 is preferably made of a rubber material of the hardness Shore D 2 ⁇ 35 range, more preferably made of a rubber material of the Shore D 2 ⁇ 30 range.
  • the cast according to the present invention is molded by injection molding to enable mass production, and then the outer shell 20 is also molded by injection molding, that is, by double injection, to cover the outer circumferential surface of the structure 10. do.
  • the material of the structure 10 and the outer shell 20 should have suitable physical properties.
  • the inventors have investigated the proper physical properties through experiments, and in the following, Describe.
  • the structure 10 is located inside the outer shell 20 and should be excellent in formability when heated to an appropriate temperature (about 70 ⁇ 80 °C) to be installed in the affected part of the patient When installed in the affected part, it must have strength to be able to withstand external impact or external force, and also have good flowability in order to be suitable for manufacturing (injection molding).
  • PCL polycaprolactone
  • the melting point was measured by DSC (differential scanning calorimeter, differential scanning calorimeter) according to ASTM D3418 at a temperature of 10 °C / min at elevated temperature, melting index (MI, melting index) according to ASTM D 1238, melting temperature 130 °C, The load was measured at 2.16kg, and the spiral flow was injected at a resin melting temperature of 130 ° C., injection pressure of 50%, and mold cooling temperature of 15 ° C. using a 90 ton injection molding machine to measure the length of the injection molded product.
  • DSC differential scanning calorimeter, differential scanning calorimeter
  • the shrinkage ratio was injected under conditions of a resin melting temperature of 130 ° C., injection pressure of 50%, mold cooling temperature of 15 ° C., and cooling time of 130 seconds using a 90-ton injection molding machine. Then, the specimen was annealed in a constant temperature and humidity chamber for 48 hours, and then The value of (mold display length-specimen display length) ⁇ mold display length ⁇ 100 was calculated by measuring the marked length and the marked length in the injection molded product.
  • the present inventors injection molded the structure by mixing a mixture of glass fiber (GF) and carbon fiber (carbon fiber, CF) to polycaprolactone having a molecular weight of 35,000 After molding by each, the strength and shrinkage of the structure 10 according to the mixing ratio of glass fiber and carbon fiber was measured, and the results are shown in Table 2 and Table 3 below.
  • Table 3 shows the change in the mechanical properties of the structure according to the mixing ratio in the case of mixing carbon fiber having an average length of 6mm to caprolactone (PCL)
  • PCL caprolactone
  • the content of carbon fiber in the structure 10 exceeds 60% by weight, the mechanical properties are excellent, but the fluidity is poor, so it is not suitable as a material for injection molding, and thus, about 10 to 60% by weight of carbon fiber is contained in the caprolactone composite.
  • the mechanical strength and shrinkage rate required for the structure are secured and the physical properties suitable for injection molding are secured.
  • the cast material of the present invention may include a nucleating agent to promote the crystal growth rate of the crystalline polymer caprolactone, in the case of using such a nucleating agent melted structure raw material (polymer) in the mold during the actual injection molding operation
  • a nucleating agent to promote the crystal growth rate of the crystalline polymer caprolactone
  • crystallization occurs from a high temperature, and as a result, the polymer solidifies quickly, so that the cooling time can be shortened and the molding time can be shortened.
  • the present inventors have described the crystallization temperature and cooling time according to the type of nucleating agent.
  • the cross-sectional shape was 3 mm in width, using a polymer containing one kind of nucleating agent mixed with a polymer containing 30 wt% of polycaprolactone having a molecular weight of 35,000 and glass fiber having an average length of 4 mm while changing the type of nucleating agent. It is made of a rectangle of 4mm in height, and the molded shape is a net-shaped structure 10, and then the nucleus species The crystallization temperature, cooling time and fluidity were tested according to the test results.
  • talc were each mixed at a ratio of 1 wt% based on polycaprolactone, and sodium benzoate, MBS, DMBS and DEBS were mixed at a ratio of 0.1 wt% based on polycaprolactone, respectively.
  • the crystallization temperature was measured by differential scanning calorimeter (DSC) according to ASTM D3418, and the solidification time was a method of predicting the molding work time. The time until after work was possible was measured, and the time measurement was performed by five gypsum yarns who had cast treatment experience to test each specimen five times, and then calculated the average time.
  • DSC differential scanning calorimeter
  • the mold cooling time was measured using a 90-ton injection molding machine to measure the minimum cooling time after the specimen was removed from the mold after injection under conditions of a resin melting temperature of 130 °C, injection pressure of 50%, and mold cooling temperature of 15 °C. will be.
  • the crystallization temperature is increased by 8 ° C compared to the case of using no nucleating agent, which significantly reduces the cooling time and the solidification time.
  • the fluidity is maintained as it is, and also it can be seen that it is possible to improve the productivity by shortening the cycle time during product molding, thus solving the molding problem due to long cycle time.
  • the outer shell 20 attached by injection molding to the outer circumferential surface of the structure 10 should have an appropriate thickness and proper strength to prevent excessive deformation of the structure 10 as described above, and should also function as a cushioning material. do.
  • the present inventors such as neoprene rubber, TPE (thermoplastic elastomer) rubber, SEBS (styrene ethylene butylene styrene) having various hardness on the outer circumferential surface of the mesh-like structure 10 to derive the shell material of the material having such a function
  • neoprene rubber thermoplastic elastomer
  • SEBS styrene ethylene butylene styrene
  • neoprene rubber, TPE rubber, SEBS rubber or silicone when the hardness of neoprene rubber, TPE rubber, SEBS rubber or silicone is low, for example, when Shore D hardness is lower than 2, the structure is excessively deformed. If the hardness is greater than Shore D hardness 35, such as Shore D hardness 40 The function is excellent, but not only bad touch and deformability when in contact with the skin was confirmed that when the cast is applied to the affected part can not be easily deformed and installed according to the body's curvature, accordingly in the present invention 2 ⁇ Use rubber or silicone with a Shore D hardness in the 35 range.
  • polycaprolactone is expensive because it is an expensive polymer and a large molecular weight
  • the inventors of the present invention such as polyethylene (PE, polyethylene), polypropylene (PP, polypropylene), polybutene (PB, In order to understand the physical properties of polybutene), polyurethane (PU, polyurethane), and polyethylene terephthalate, the synthetic resins were blended with polycaprolactone, respectively. same.
  • injection specimens were prepared using a polymer blended with 30 wt% of 4mm glass fiber and 20 wt% of synthetic resin in polycaprolactone having a molecular weight of 35,000 used in the experiments of Table 4 to measure physical properties and formability.
  • polycaprolactone When blending each synthetic resin to polycaprolactone, polycaprolactone functions as a matrix, and the blended synthetic resin functions as a domain so that the content of synthetic resin (about 20% by weight relative to polycaprolactone) may be used.
  • each was adjusted so that the cast of the mesh structure could be deformed even when the heating temperature did not reach the melting point of the resin when the cast was heated to perform a cast on the affected part of the patient.
  • Synthetic resin unit none PE PP PB PU PET Processing temperature °C 170 180 220 200 200 280 Cooling time sec 115 120 170 160 160 290 The tensile strength kg f / cm2 385 368 374 357 376 379 modulus kg f / cm2 24,251 23,857 24,110 23,052 24,185 24,850 Impact strength kg f / cm2 13.7 14.2 12.6 13.0 14.1 13.5 Solidification time sec 210 293 278 305 307 272
  • polyethylene, polypropylene, and polybutene as polymers for forming the structure 10 are relatively lightweight and inexpensive, and polyurethane or polyethylene terephthalate is inexpensive, thus blending any one or more of the above synthetic resins.
  • polycaprolactone it is possible to produce a cast that is light and inexpensive while maintaining mechanical properties.
  • the outer shell 20 is not produced by the injection molding mixture of the binder and the rubber solution
  • the outer shell 20 is formed by dipping and dipping the entire structure 10 in the reservoir, or a pair of sheets of rubber or silicon is placed up and down, and the structure 10 is interposed between these sheets.
  • the outer shell 20 may be molded by fusion (sheet fusion) of the upper and lower sheets by ultrasonic welding or thermal fusion in the state where) is placed.
  • the present invention is made of a polycaprolactone composite having a reinforced structure of the cast skeleton, and the soft skin is wrapped around the structure to function as a reinforcement and deformation limiting factor for the structure to the affected part
  • the cast procedure is easy and ensures the proper strength of the cast.

Abstract

The present invention relates to a thermoplastic cast which is reusable. The cast according to the present invention comprises: a structure (10) made of a polycaprolactone composite and having a net shape in which polygonal apertures are repeatedly formed; and an outer cover (20) attached to the external circumferential surface of the structure (10), wherein the melting point of the polycaprolactone composite forming the structure (10) is 50 to 80°C, and wherein the outer cover (20) is made of a rubber material or silicone having a shore D hardness of 2 to 35. Due to this configuration, the cast according to the present invention is, while structurally robust, simple in procedure and suitable for mass production.

Description

변형성과 강성이 우수한 열가소성 캐스트Highly deformable and rigid thermoplastic cast
본 발명은 변형성과 강성이 우수한 열가소성 캐스트에 관한 것으로, 더욱 상세하게는 열가소성 재질로 이루어져 인간이나 동물의 팔다리나 신체 부분이 골절 또는 손상된 경우 손상된 부위(환부)가 치료 과정에서 움직이는 것을 방지하는 변형성과 강성이 우수한 열가소성 캐스트에 관한 것이다.The present invention relates to a thermoplastic cast having excellent deformability and rigidity. More specifically, the present invention relates to a thermoplastic cast having a deformability and rigidity. A thermoplastic cast having excellent rigidity.
일반적으로 관절이나 팔다리가 골절되거나 손상된 경우 원활한 치료가 이루어질 수 있도록 캐스트, 깁스, 스프린터 또는 교정장구(브레이스) 등(이하 '캐스트'라 통칭한다.)을 이용하여 손상된 관절이나 팔다리 또는 척추 등을 고정한다.In general, if a joint or limb is fractured or damaged, the damaged joint, limb or spine is fixed using a cast, cast, sprinter, or corrective tool (brace), etc., so that a smooth treatment can be performed. do.
종래에는 이러한 손상된 관절이나 팔다리를 고정하기 위해 일반적으로 붕대와 석고를 이용하여 환부에 깁스를 설치하고 있으나, 이러한 석고는 무거울 뿐만 아니라 일단 응고되고 나면 재성형할 수 없고, 또한 습기에 노출되는 경우 열화되거나 손상되기 때문에 환자가 목욕이나 샤워하기가 곤란하며, 아울러 깁스가 설치된 부분에는 공기가 쉽게 통하지 않는다는 등의 단점이 있다.Conventionally, in order to fix such damaged joints or limbs, casts are generally installed on the affected areas using bandages and plasters, but these plasters are not only heavy but also cannot be remolded once solidified and deteriorated when exposed to moisture. It is difficult for a patient to bathe or shower because it is damaged or damaged, and air is not easily passed to the part where the cast is installed.
상기와 같은 이유로 최근에는 목욕이나 샤워를 하더라도 손상되지 않고, 또한 공기가 쉽게 유통되도록 하는 구조의 캐스트가 개발되고 있는데, 그 하나의 예로서 미국 특허공보 제6,673,029호에 개시된 캐스트를 들 수 있으며, 이 캐스트는 도 1a 및 도 1b에 도시된 바와 같이 비교적 그 눈(120)의 크기가 큰 망 형상으로 이루어지고, 이때 망 형상을 이루는 소재는 신체 부위를 강건하게 지지하고 보호하는데 충분한 강도를 가질 수 있도록 수지가 함침된 화이버글라스 화이버(110)를 6-12 층으로 적층하여 판재 형태로 형성한 다음, 이러한 판재 형상의 소재를 눈의 형상이 육각형의 메시 배열이 이루어지도록 절단한 것으로서, 이러한 캐스트(100, 망상체)는 수지가 함침된 화이버글라스 화이버(110)를 여러 층으로 적층하기가 곤란할 뿐만 아니라, 상기와 같이 수지가 함침된 화이버글라스 화이버(110)를 여러 층으로 적층하게 되면 수지를 함침하는 과정에서의 함침의 불균일로 인해 화이버 층의 표면이 매끄럽지 않게 되고, 이렇게 매끄럽지 않은 표면으로 이루어진 캐스트(100)를 착용하게 되면 그로 인해 환자가 불편을 느낄 수 있다는 단점이 있다.For the same reason, casts have been recently developed that are not damaged even when bathed or showered, and that air is easily distributed. As an example, a cast disclosed in US Patent No. 6,673,029 may be used. As shown in FIGS. 1A and 1B, the cast is made of a mesh shape having a relatively large size of the eye 120, in which the material forming the mesh shape has sufficient strength to firmly support and protect the body part. The resin-impregnated fiberglass fiber 110 is laminated in 6-12 layers to form a plate shape, and then the plate-shaped material is cut to form an hexagonal mesh array of eyes. , Reticular) is not only difficult to laminate the resin impregnated fiberglass fiber 110 in multiple layers, but also as described above When the impregnated fiberglass fiber 110 is laminated in several layers, the surface of the fiber layer is not smooth due to the unevenness of the impregnation during the resin impregnation process, so that the cast 100 made of such a smooth surface is worn. Thereby, there is a disadvantage that the patient may feel uncomfortable.
그리고 상기 특허는 캐스트(100)를 망상체 형태로 제조하기 위해 먼저 화이버글라스 화이버(110)를 사용하여 천을 만든 다음, 천에서 마름모 형상을 절단해 냄으로써 눈을 만들기 때문에 절단된 부분으로부터 화이버글라스 화이버(110)의 올이 풀려질 수 있고, 이 경우 캐스트(100)의 강도가 약해질 수 있으며, 또한 풀린 올 부분에 수지가 함침된 경우 이 부분이 뾰족하게 되어 사용자의 피부를 자극할 우려가 있다.In order to manufacture the cast 100 in the form of a reticular body, the patent first uses a fiberglass fiber 110 to make a cloth, and then cuts a diamond shape from the cloth to make an eye, thereby making the fiberglass fiber 110 ) Can be loosened, and in this case, the strength of the cast 100 may be weakened, and when the resin is impregnated in the loosened all-parts, this part becomes sharp and may irritate the user's skin.
더구나 상기 캐스트(100)는 수경화성 수지를 함침시켜 제조하기 때문에 제조과정에서 물이나 수분과의 접촉이 방지되어야 하므로 캐스트를 제조할 때에는 수분이나 습기가 제거된 밀폐공간에서 이루어져야 하기 때문에 생산성이 낮고, 제조 후에도 수분과의 접촉이 차단되어야 하기 때문에 제조된 캐스트를 밀봉하여 보관하여야 하므로 제조관리와 비용이 많이 드는 문제가 있으며, 또한 한 번 경화되고 나면 다시 사용할 수 없기 때문에 환자의 회복정도에 따라 캐스트(100)를 수정할 필요가 있는 경우에도 캐스트(100)의 수정과 재사용이 곤란하다는 문제도 있다.Moreover, since the cast 100 is manufactured by impregnating with a water-curable resin, contact with water or moisture should be prevented in the manufacturing process, and thus, when the cast is manufactured, productivity is low because the cast 100 should be made in a closed space from which moisture or moisture is removed. Since the contact with moisture must be blocked even after manufacture, the manufactured cast must be sealed and stored.Therefore, there is a problem in manufacturing management and cost, and once it is cured, it cannot be used again. Even if it is necessary to modify 100, there is a problem that it is difficult to modify and reuse the cast 100.
상기와 같은 수경화성 캐스트가 가지는 문제점을 해결하기 위해 열가소성 망상체로 이루어진 캐스트가 개발되고 있으며, 그 하나의 예로서 미국 특허공개공보 2008-0154164호에 개시된 열가소성 캐스트를 들 수 있다.In order to solve the problems of the above water-curable cast, a cast made of a thermoplastic network has been developed, and one example thereof includes the thermoplastic cast disclosed in US Patent Application Publication No. 2008-0154164.
상기 미국 특허공개공보 2008-0154164호에 개시된 캐스트는 도 2a 및 도 2b에 도시된 바와 같이 캐스트(200)의 스프린트 부재(210)를 대략 다이아몬드 형상의 개구를 가진 망 형상으로 형성함으로써 이들 사이에 복수 개의 마름모 형상의 통로(220)가 형성되도록 한 것으로, 이때 스프린트 부재(210)의 소재는 신체 부위를 강건하게 지지하고 보호하는 데에 충분한 강도를 가질 수 있도록 저온 성형이 가능한 폴리카프로락톤 복합재료로 이루어진 기재에 리그노셀룰로오스 등의 첨가제가 혼합된 소재가 사용되며, 이러한 구조 및 사용 소재에 의해 변의 길이방향으로의 '신장'은 제한되면서도 축선 1과 축선 3의 방향과 평행하는 방향으로는 쉽게 늘어날 수 있도록 함으로써 신체의 외형에 따라 망상체에 형성된 마름모의 형상이 쉽게 변형(이하, 이를 '변형'이라 칭함으로써 변이 길이가 늘어나는 것을 의미하는 '신장'과 구별한다.)되도록 하여 시술의 용이성을 도모한 것이다.The cast disclosed in U.S. Patent Application Publication No. 2008-0154164 discloses a plurality of casts therebetween by forming the sprint member 210 of the cast 200 into a mesh having an approximately diamond-shaped opening, as shown in FIGS. 2A and 2B. Four rhombus-shaped passages 220 are formed, wherein the material of the sprint member 210 is a polycaprolactone composite material that can be formed at a low temperature so as to have sufficient strength to firmly support and protect a body part. A material in which additives such as lignocellulosic is mixed is used for the formed base material, and the 'extension' in the longitudinal direction of the side is limited by such a structure and the used material, but it is easily stretched in a direction parallel to the directions of axis 1 and axis 3. The shape of the rhombus formed on the network according to the appearance of the body can be easily deformed (hereinafter, referred to as 'deformation'). It is distinguished from 'height', which means that the length of the mutation increases.)
그러나 상기 특허문헌에 개시된 캐스트는 변형이 용이하여 환자의 신체에의 시술은 비교적 수월하지만, 망 형상의 스프린트 부재(210)의 단면 전체가 리그노셀룰로오스가 첨가된 폴리카프로락톤 복합재료에 의해 성형되기 때문에 강도가 상대적으로 약하다는 단점이 있으며, 또한 이러한 재질의 무름으로 인해 변의 길이방향으로의 신장이 제한되지 못하고 어느 정도 늘어나게 되며, 이 경우 변의 두께가 줄어들게 되어 이에 의해서도 캐스트의 강도가 약해질 수 있다는 단점이 있다.However, the cast disclosed in the patent document is easy to deform, so that the procedure to the patient's body is relatively easy, but the entire cross section of the mesh-shaped sprint member 210 is formed by a polycaprolactone composite material to which lignocellulose is added. Therefore, the strength is relatively weak, and because of the softness of the material is not limited to the elongation in the longitudinal direction of the side is increased to some extent, in this case the thickness of the side is reduced, thereby weakening the cast strength There are disadvantages.
한편, 상기와 같은 소재로 이루어진 캐스트를 사용할 때에는 먼저 환자의 피부를 보호하기 위해 환부 주위에 눈의 크기가 상대적으로 작은 망 형태의 하부 패드(underlying padding, 또는 피부보호대)를 설치한 다음, 이 하부 패드의 상부에 상대적으로 눈의 크기가 큰 망 형상의 캐스트를 가열함으로써 가소성이 유지된 상태에서 환부에 둘러 성형한 다음 클립 등으로 고정함으로써 시술하는데, 이와 같이 캐스트의 하부에 하부 패드를 설치하는 경우 통풍이 원활하지 못하고, 또한 샤워 등으로 인해 하부 패드에 물기가 스며들게 되면 하부 패드에 오랜 시간 동안 습기가 남아 있을 수 있기 때문에 사용자가 불편을 느낄 수 있다.On the other hand, when using a cast made of such a material, first, an underlying padding or skin protector having a relatively small eye size is installed around the affected part to protect the skin of the patient. In the state where plasticity is maintained by heating a web-shaped cast having a relatively large eye size on the upper part of the pad, it is formed by surrounding the affected part and fixing it with a clip or the like. In the case where the lower pad is installed below the cast, If the ventilation is not smooth, and the lower pad gets wet due to the shower, the user may feel uncomfortable because moisture may remain on the lower pad for a long time.
이에 더하여 상기와 같이 캐스트의 하부에 하부 패드를 추가 설치하는 경우 상부 캐스트와 하부 패드 간의 접촉에 의해 하부 패드가 자유로이 유동되지 못하고 밀리는 현상이 발생되기도 하여 불편하고, 또한 하부 패드의 사용기간이 캐스트 사용기간보다 짧기 때문에 하부 패드를 가끔 교환하여야 하는데 이 경우 먼저 캐스트에 열을 가하여 캐스트를 녹인 다음 하부 패드를 교환한 후 재차 캐스트를 성형하여야 하기 때문에 그 교환절차가 까다롭고 불편하다는 문제도 있다. In addition, when the lower pad is additionally installed in the lower part of the cast as described above, the lower pad may not be freely flown due to the contact between the upper cast and the lower pad, which may be uncomfortable. The lower pad should be replaced occasionally because it is shorter than the period. In this case, it is difficult and inconvenient to replace the lower pad by first melting the cast and then replacing the lower pad and forming the cast again.
열가소성 소재를 이용하는 캐스트의 또 다른 예로서 공개특허공보 10-2005-74734호에 개시된 수지조성물을 이용한 정형외과용 고정재(캐스트)를 들 수 있는데, 이 문헌에 개시된 캐스트는 폴리카프로락톤과 열가소성 폴리우레탄 및 충전제를 특정비율로 혼합한 소재를 이용하여 사출 성형에 의해 제조한 것으로, 캐스트가상대적으로 강도가 약한 폴리카프로락톤과 폴리우레탄을 주재로 하기 때문에 시술과정에서 캐스트가 과도하게 신장될 수 있을 뿐 만 아니라 시술 후에도 변형될 수 있으며, 또한 캐스트가 폴리카프로락톤 복합재 층(layer)으로만 이루어져 있기 때문에 환부에 캐스트를 시술과정에서 과도하게 신장될 수 있고, 또한 캐스트의 표면이 딱딱하여 환자의 피부에 접촉하는 경우 불편을 호소할 수 있다.Another example of a cast using a thermoplastic material is an orthopedic fixation material (cast) using the resin composition disclosed in Korean Patent Application Publication No. 10-2005-74734. The cast disclosed in this document includes polycaprolactone and thermoplastic polyurethane. And it is manufactured by injection molding using a material in which the filler is mixed at a specific ratio, the cast can be excessively elongated during the procedure because the cast is mainly made of polycaprolactone and polyurethane, which is relatively weak in strength. Not only can it be deformed after the procedure, but because the cast consists only of a polycaprolactone composite layer, the cast can be stretched excessively during the procedure, and the surface of the cast is hard to the patient's skin. Contact may cause discomfort.
따라서 환자의 신체부위에 캐스트를 시술할 때 변의 길이 방향으로의 신장은 제한되도록 함으로써 캐스트의 강도는 그대로 유지될 수 있고, 환자의 신체부위의 외형에 따라 마름모 형태의 눈은 쉽게 변형될 수 있도록 함으로써 캐스트를 쉽게 시술할 수 있도록 하면서도 과도한 변형이 방지되며, 또한 대량생산이 가능한 소재로 이루어진 캐스트의 개발이 요구된다.Therefore, when the cast is applied to the patient's body part, the stretch in the longitudinal direction of the side can be limited, so that the strength of the cast can be maintained and the rhombus-shaped eye can be easily deformed according to the shape of the patient's body part. It is necessary to develop a cast made of a material which can be easily processed and prevents excessive deformation and can be mass-produced.
본 발명은 상기와 같은 종래의 열가소성 소재로 이루어진 망 형상의 캐스트가 가지는 문제점을 해소하기 위해 안출된 것으로, 충분한 강도를 가지면서도 변형성이 우수하고, 착용시 사용자가 불편함을 느끼지 않으며, 대량생산에 적합한 변형성과 강성이 우수한 열가소성 캐스트를 제공하는 데에 그 목적이 있다.The present invention has been devised to solve the problems of the cast of the mesh shape made of a conventional thermoplastic material as described above, having sufficient strength and excellent deformability, and does not feel inconvenience for the user when worn, mass production The aim is to provide a thermoplastic cast with good deformability and rigidity.
상기와 같은 본 발명의 목적은 캐스트를, 폴리카프로락톤 복합재로 이루어지며, 다각 형상의 개구가 반복적으로 형성됨으로써 그물 형상을 가지는 구조체와; 구조체의 외주면에 부착되는 외피로 이루어지고, 구조체를 이루는 폴리카프로락톤 복합재의 융점은 50~80℃의 범위를 가지며, 외피는 2~35 범위의 Shore D 경도를 가지는 고무재질 또는 실리콘으로 구성하는 것에 의해 달성된다.An object of the present invention as described above is made of a polycaprolactone composite cast, the structure having a mesh shape by repeatedly opening the polygonal shape; The melting point of the polycaprolactone composite material constituting the structure, the outer surface of the structure consists of a rubber material or silicone having a Shore D hardness in the range of 2 ~ 35 range Is achieved.
이때 그물 형상의 구조체는 사출 성형 또는 압축 성형(press)에 의해 성형되고, 구조체의 외주면에 부착되는 외피는 구조체가 금형의 내부에 설치된 상태에서 사출 성형이 이루어지는 인서트 사출에 의해 성형되는 것이 바람직하다.At this time, the mesh-like structure is molded by injection molding or compression molding (press), it is preferable that the outer skin attached to the outer peripheral surface of the structure is molded by insert injection in which the injection molding is made with the structure installed in the mold.
또한 구조체를 이루는 폴리카프로락톤 복합재는 분자량 20,000 ~ 80,000 범위의 폴리카프로락톤을 포함하는 것이 바람직하다.In addition, the polycaprolactone composite constituting the structure preferably includes polycaprolactone having a molecular weight in the range of 20,000 to 80,000.
그리고 폴리카프로락톤 복합재에는 폴리에틸렌, 폴리프로필렌, 폴리부텐, 폴리우레탄, 폴리에틸렌프탈레이트 중 어느 하나 이상의 합성수지가 블랜딩에 의해 첨가되는 것이 바람직하다.The polycaprolactone composite is preferably one or more synthetic resins of polyethylene, polypropylene, polybutene, polyurethane, and polyethylene phthalate by blending.
이에 더하여 폴리카프로락톤 복합재에는 유리섬유 또는 카본섬유로 이루어진 강도 보강재가 혼합되고, 강도 보강재는 카프로락톤 복합재에 대해 10∼60 중량% 혼합되는 것이 더욱 바람직하다.In addition, the polycaprolactone composite material is mixed with strength reinforcement made of glass fiber or carbon fiber, and the strength reinforcement material is more preferably mixed with 10 to 60% by weight based on the caprolactone composite.
그리고 폴리카프로락톤 복합재에는 칼슘카보네이트, 탈크, 소듐벤조에이트, MBS, DMBS 및 DEBS 중 어느 한 개 이상의 핵제가 첨가되는 것이 더욱 바람직하다.And it is more preferable to add one or more nucleating agents of calcium carbonate, talc, sodium benzoate, MBS, DMBS and DEBS to the polycaprolactone composite.
본 발명은 캐스트가 그물 형상을 가지기 때문에 통풍성이 향상된다.The present invention improves breathability because the cast has a net shape.
또한 본 발명은 구조체가 강도가 보강된 폴리카프로락톤 복합재로 이루어지고, 이러한 구조체를 연질의 외피가 감쌈으로써 외피가 구조체에 대한 보강재 및 변형 제한요소로 기능함으로써 환부에의 캐스트 시술이 용이하면서도 캐스트의 적절한 강도가 확보된다.In addition, the present invention is made of a polycaprolactone composite with reinforced structure, the soft outer shell wraps the structure to serve as a reinforcement and deformation limiting element for the structure to facilitate the cast procedure to the affected area Adequate strength is ensured.
그리고 본 발명은 구조체와 외피를 성형하기 위한 소재가 사출 성형에 적합한 소재로 이루어져 있기 때문에 이중 사출에 의한 대량생산이 가능하다.In the present invention, since the material for forming the structure and the shell is made of a material suitable for injection molding, mass production by double injection is possible.
이에 더하여 본 발명은 상대적으로 연질의 소재로 이루어진 외피가 딱딱한 구조체의 외주면을 감싸고 있기 때문에 환자의 피부에 캐스트이 표면(외피)이 접촉하는 경우에도 불편을 느끼지 않는다.In addition, the present invention does not feel uncomfortable even when the cast (surface) is in contact with the skin of the patient because the outer shell made of a relatively soft material surrounds the outer peripheral surface of the rigid structure.
도 1a와 도 1b는 종래의 캐스트의 예를 보인 도면,1A and 1B show an example of a conventional cast,
도 2a와 도 2b는 종래의 캐스트의 또 다른 예를 보인 도면,2a and 2b show another example of a conventional cast,
도 3은 본 발명에 따른 열가소성 캐스트의 단면 모양을 나타낸 단면도,3 is a cross-sectional view showing the cross-sectional shape of the thermoplastic cast according to the present invention;
도 4는 본 발명에 따른 열가소성 캐스트의 외형도이다.4 is an external view of a thermoplastic cast according to the present invention.
<부호의 설명><Description of the code>
1: 캐스트 10: 구조체1: cast 10: structures
20: 외피20: shell
이하에서는 바람직한 실시예를 도시한 첨부 도면을 통해 본 발명의 구성과 작용을 더욱 상세히 설명한다.Hereinafter, the configuration and operation of the present invention through the accompanying drawings showing a preferred embodiment in more detail.
본 발명은 환자의 골절 부위 등을 감싸 고정하거나 교정하기 위해 사용되는 열가소성 캐스트의 조성물에 관한 것으로, 본 발명에 따른 캐스트는 도 3에 도시된 바와 같이 구조체(10)와 이 구조체(10)의 외주면을 감싸는 외피(20)로 이루어지고, 이때 구조체(10)는 사출성형 또는 압축 성형에 의해 제조되고, 외피(20)는 사출성형에 의해 제조된다.The present invention relates to a composition of a thermoplastic cast used to wrap around, fix or correct a fracture site of a patient, the cast according to the present invention having a structure 10 and an outer circumferential surface of the structure 10 as shown in FIG. It consists of a shell 20 surrounding the structure, wherein the structure 10 is manufactured by injection molding or compression molding, the shell 20 is manufactured by injection molding.
구조체(10)는 다각 형상의 개구부가 규칙적으로 형성됨으로써 그물 형상을 가지며, 이때 그물 형상을 이루는 변의 단면은 외력이나 충격에 대해 충분한 강성이 확보될 수 있도록 폭보다 높이가 상대적으로 더 큰 사각 형상을 가지도록 성형되며, 이러한 구조체(10)는 폴리카프로락톤(PCL, polycaprolactone)을 주재로 하는 폴리카프로락톤 복합재로 이루어진다. Structure 10 has a net shape by the regular opening of the polygonal shape, wherein the cross section of the side forming the net shape has a rectangular shape that is relatively higher in height than the width to ensure sufficient rigidity against external force or impact Molded to have such a structure 10 is made of a polycaprolactone composite based on polycaprolactone (PCL, polycaprolactone).
구조체(10)를 구성하는 폴리카프로락톤 복합재의 주재로서 폴리카프로락톤이 사용되며, 본 발명에 사용되는 폴리카프로락톤은 카프로락톤의 개환중합에 의해 생성되는 폴리에스터의 일종으로서 결정성 고분자이며, 50~80℃의 낮은 융점을 가진다.Polycaprolactone is used as a main material of the polycaprolactone composite constituting the structure 10. The polycaprolactone used in the present invention is a kind of polyester produced by ring-opening polymerization of caprolactone, and is a crystalline polymer. It has a low melting point of ˜80 ° C.
또한 본 발명에 사용되는 폴리카프로락톤(PCL)은 분자량이 20,000∼80,000 범위인 것이 사용되는데, 이는 폴리카프로락톤의 분자량이 20,000 미만인 경우 아래의 표 1에서 알 수 있는 바와 같이 기계적 물성(충격강도)이 낮기 때문에 구조체로서의 역할을 기대할 수 없고, 따라서 분자량이 큰 것을 사용하는 것이 바람직하지만, 분자량이 80,000보다 큰 경우 굴곡강도(modulus)와 흐름성이 나빠지게 되어 사출 성형을 위한 재료로서 부적합하다는데 따른 것이다.In addition, the polycaprolactone (PCL) used in the present invention has a molecular weight in the range of 20,000 to 80,000, which is the mechanical properties (impact strength) as shown in Table 1 below when the molecular weight of polycaprolactone is less than 20,000 Since it is low, it cannot be expected to serve as a structure, and therefore, it is preferable to use one having a large molecular weight. However, when the molecular weight is larger than 80,000, the flexural strength and flowability become worse, which is unsuitable as a material for injection molding. will be.
또한 상기 조건하에서 폴리카프로락톤의 융점은 약 50∼80℃ 범위를 가지게 되며, 이에 의해 환부에 캐스트를 쉽게 시술할 수 있다.In addition, the melting point of the polycaprolactone under the above conditions is in the range of about 50 ~ 80 ℃, whereby the cast on the affected area can be easily performed.
그러나 상기와 같이 구조체(10)를 폴리카프로락톤만으로 제조하는 경우 기계적 물성, 특히 인장강도가 너무 낮아 환부를 고정지지하기 위한 캐스트로서 사용하기 곤란하며, 이에 따라 본 발명에서는 인장강도 등의 기계적 물성을 향상시킬 수 있도록 주재(폴리카프로락톤)에 강도 보강재를 첨가하는데, 이러한 강도 보강재로서 섬유강화 유리섬유(fiber reinforced glass fiber) 또는 카본섬유(carbon fiber)가 사용된다.However, when the structure 10 is made of only polycaprolactone as described above, the mechanical properties, in particular, the tensile strength is so low that it is difficult to use as a cast for supporting the affected part, and accordingly, in the present invention, mechanical properties such as tensile strength A strength reinforcing material is added to the main material (polycaprolactone) to be improved, and as such strength reinforcing material, fiber reinforced glass fiber or carbon fiber is used.
그리고 구조체(10)에는 핵제가 첨가되며, 이러한 핵제는 용융 온도에는 영향을 주지 않으면서 결정성 고분자의 결정화 온도를 올려주고 결정의 성장속도를 빠르게 해 주는 역할을 하며, 이때 핵제로서 칼슘카보네이트(calcium carbonate), DMBS(Di-p-methylbenzylidene sorbitol), DEBS(N,N′-Diphenyl-2,2′-Diselenodibenzoamide Di-p-ethylbenzylidene sorbitol), MBS(monobenzylidene sorbitol), 탈크(talc), 소듐벤조에이트(Sodium Benzoate) 등이 사용될 수 있다. The nucleating agent is added to the structure 10, and the nucleating agent raises the crystallization temperature of the crystalline polymer and accelerates the growth rate of the crystal without affecting the melting temperature. carbonate), DMBS (Di-p-methylbenzylidene sorbitol), DEBS (N, N'-Diphenyl-2,2'-Diselenodibenzoamide Di-p-ethylbenzylidene sorbitol), MBS (monobenzylidene sorbitol), talc (talc), sodium benzoate (Sodium Benzoate) and the like can be used.
캐스트를 환자의 환부에 시술할 때에는 먼저 캐스트를 뜨거운 물에 넣거나 가열기 등에 의해 가열하여 캐스트를 연화시킨 다음, 신체의 외형에 맞추어 캐스트의 형상을 변형시켜 가면서 시술하는데, 이때 상기와 같은 재질로 이루어진 구조체(10)만으로 캐스트를 제조하는 경우 구조체(10)의 신장이 과도하게 될 우려가 있을 뿐만 아니라, 신체의 외부에 설치되고 나면 그 표면이 딱딱하여 환자의 피부와 접촉하는 경우 환자가 불편할 수 있다.When the cast is applied to the affected part of the patient, the cast is first put in hot water or heated by a heater to soften the cast, and then the cast is deformed according to the appearance of the body. In the case of manufacturing the cast using only (10), not only the structure 10 may be excessively stretched, but may also be uncomfortable when the surface of the structure 10 is hard to come into contact with the patient's skin.
이에 따라 본 발명의 캐스트는 구조체(10)의 외주면에 외피(20)가 성형 부착되는 구조를 가지는데, 이러한 외피(20)는 용융된 구조체(10)를 감싸 구조체의 과도한 신장을 방지함으로써 그물 형상을 이루는 사각형의 형상이 그대로 유지되도록 하는 동시에 연신에 따른 두께가 얇아지는 것을 방지하여 강도가 저하되는 현상을 방지하고, 아울러 구조체(10)의 딱딱한 표면이 환자의 피부에 직접 접촉하는 것을 방지하는 완충재로서 기능한다.Accordingly, the cast of the present invention has a structure in which the outer shell 20 is molded and attached to the outer circumferential surface of the structure 10, and the outer shell 20 wraps the molten structure 10 to prevent excessive elongation of the structure to form a net shape. A cushioning material that maintains the shape of the rectangular shape as it is, and at the same time prevents the thickness from being thinned, thereby reducing the strength, and also prevents the hard surface of the structure 10 from directly contacting the patient's skin. Function as.
외피(20)가 상기와 같은 기능, 즉 구조체(10)가 과도하게 신장됨으로써 결과적으로 두께가 얇아져 강도가 저하되는 현상을 방지하는 기능을 가지기 위해서는 적절한 두께를 가지는 동시에 적절한 강도를 가져야 하고, 또한 완충재로서 기능하기 위해서는 탄성을 가져야 하는데, 이를 위해 외피(20)는 경도 Shore D 2~35 범위의 고무 재질로 이루어지는 것이 바람직하고, 더욱 바람직하게는 Shore D 2~30범위의 고무재질로 이루어진다. In order for the outer shell 20 to have a function as described above, that is, the structure 10 is excessively elongated and consequently thin, resulting in a decrease in strength, the outer shell 20 must have an appropriate thickness and an appropriate strength. In order to function as it should have elasticity, for this purpose, the outer shell 20 is preferably made of a rubber material of the hardness Shore D 2 ~ 35 range, more preferably made of a rubber material of the Shore D 2 ~ 30 range.
한편, 본 발명에 따른 캐스트는 대량 생산이 가능하도록 구조체(10)를 사출에 의해 성형한 다음, 외피(20)도 구조체(10)의 외주면을 감싸도록 사출성형에 의해, 즉 이중사출에 의해 성형한다.Meanwhile, the cast according to the present invention is molded by injection molding to enable mass production, and then the outer shell 20 is also molded by injection molding, that is, by double injection, to cover the outer circumferential surface of the structure 10. do.
상기와 같이 캐스트를 이중사출에 의해 제조하기 위해서는 구조체(10)와 외피(20)의 재질이 이에 적합한 물성을 가져야 하는데, 이를 위해 본 발명자 등은 실험을 통해 적합한 물성을 조사하였으며, 이하에서는 이에 대해 기술한다.In order to manufacture the cast by double injection as described above, the material of the structure 10 and the outer shell 20 should have suitable physical properties. For this purpose, the inventors have investigated the proper physical properties through experiments, and in the following, Describe.
먼저, 구조체의 기능과 관련하여 살펴보면, 구조체(10)는 외피(20)의 내부에 위치하면서 환자의 환부에 설치하기 위해 적절한 온도(70~80℃ 내외)로 가열하였을 때에는 성형성이 우수하여야 하고, 환부에 설치되었을 때에는 외부 충격이나 외력에도 견고하게 견딜 수 있는 강도를 가져야 하며, 또한 제작(사출성형)에 적합하도록 하기 위해서는 흐름성이 양호하여야 한다.First, in relation to the function of the structure, the structure 10 is located inside the outer shell 20 and should be excellent in formability when heated to an appropriate temperature (about 70 ~ 80 ℃) to be installed in the affected part of the patient When installed in the affected part, it must have strength to be able to withstand external impact or external force, and also have good flowability in order to be suitable for manufacturing (injection molding).
이에 따라 구조체(10)의 주재인 폴리카프로락톤(PCL)의 분자량의 변화에 따른 흐름성과 기계적 강도에 대해 실험하였으며, 아래의 표 1에 도시된 바와 같은 결과를 얻었다.Accordingly, the flow and mechanical strength of the polycaprolactone (PCL), which is the main body of the structure 10, were tested. The results as shown in Table 1 below were obtained.
실험에 있어서 인장강도는 미국재료시험협회(ASTM)의 측정방법 중 ASTM D638에 의거하여 UTM(Universal Testing Machine)으로 측정하였고, modulus는 ASTM D 790에 의거하여 UTM으로 측정하였고, 충격강도는 ASTM D256에 의거하여 상온(23℃)에서 Izod Notch 충격강도를 측정하였다. 또한 용융점은 ASTM D3418에 의거하여 DSC(differential scanning calorimeter, 시차주사열량계)로 승온 강온시 10℃/min으로 측정하였으며, MI(용융지수, melting index)는 ASTM D 1238에 의거하여 용융온도 130℃, 하중 2.16kg에서 측정하였고, Spiral Flow는 형체력 90톤 사출기를 사용하여 수지 용융온도 130℃, 사출압력 50%, 금형냉각온도 15℃에서 사출하여 사출물의 길이를 측정하였다.Tensile strength in the test was measured by UTM (Universal Testing Machine) in accordance with ASTM D638 of the American Society for Testing and Materials (ASTM) measurement method, modulus was measured by UTM in accordance with ASTM D 790, impact strength is ASTM D256 Based on the Izod Notch impact strength was measured at room temperature (23 ℃). In addition, the melting point was measured by DSC (differential scanning calorimeter, differential scanning calorimeter) according to ASTM D3418 at a temperature of 10 ℃ / min at elevated temperature, melting index (MI, melting index) according to ASTM D 1238, melting temperature 130 ℃, The load was measured at 2.16kg, and the spiral flow was injected at a resin melting temperature of 130 ° C., injection pressure of 50%, and mold cooling temperature of 15 ° C. using a 90 ton injection molding machine to measure the length of the injection molded product.
그리고 수축율은 형체력 90톤 사출기를 사용하여 수지 용융온도 130℃, 사출압력 50%, 금형냉각온도 15℃, 냉각시간 130 초의 조건으로 사출한 다음, 시편을 항온항습실에서 48시간 어닐링한 후, 금형에서의 일정길이를 표시한 부분과 사출물에서 표시된 길이를 측정하여 (금형표시길이-시편표시길이)ㆇ금형표시길이ㅧ100의 값을 산출하였다.The shrinkage ratio was injected under conditions of a resin melting temperature of 130 ° C., injection pressure of 50%, mold cooling temperature of 15 ° C., and cooling time of 130 seconds using a 90-ton injection molding machine. Then, the specimen was annealed in a constant temperature and humidity chamber for 48 hours, and then The value of (mold display length-specimen display length) ㆇ mold display length ㅧ 100 was calculated by measuring the marked length and the marked length in the injection molded product.
분자량Molecular Weight 13,00013,000 20,00020,000 35,00035,000 50,00050,000 80,00080,000 100,000100,000
인장강도The tensile strength kgf/㎠kg f / ㎠ 183183 182182 178178 160160 145145 134134
modulusmodulus kgf/㎠kg f / ㎠ 6,3306,330 6,1416,141 5,2675,267 4,8874,887 4,3154,315 3,8923,892
충격강도Impact strength kgf/㎠kg f / 22 33 77 88 88 1010
유동성liquidity Spiral flowSpiral flow Cm 125125 9595 5959 3636 1919 77
MIMI g/10ming / 10min 430430 135135 5454 1212 33 0.50.5
용융점Melting point 6262 6262 6262 6262 6262 6161
위의 표 1(폴리카프로락톤의 분자량별 흐름성 및 기계적 강도 실험결과)로부터 확인할 수 있는 바와 같이 분자량 13,000~100,000의 범위에서 폴리카프로락톤의 융점은 62℃로 거의 동일하고, 분자량이 커질수록 충격강도는 좋아지지만, 굴곡강도(modulus)와 흐름성(유동성)이 저하되며, 또한 캐스트의 구조적 건전성을 담보하는 구조체로서 기능할 수 있을 정도의 충분한 강도가 확보되지 않는다.As can be seen from the above Table 1 (flow rate and mechanical strength test results by molecular weight of polycaprolactone), the melting point of polycaprolactone in the range of molecular weight of 13,000 ~ 100,000 is almost the same as 62 ℃, the higher the molecular weight impact Although the strength is improved, the flexural strength (modulus) and flowability (fluidity) are lowered, and sufficient strength is not secured enough to function as a structure to ensure the structural integrity of the cast.
구조체(10)의 충분한 강도를 확보하기 위해 본 발명자 등은 분자량 35,000의 폴리카프로락톤에 유리섬유(glass fiber, GF)와 카본섬유(carbon fiber, CF)를 여러 가지 비율로 혼합하여 구조체를 사출성형에 의해 각각 성형한 다음, 유리섬유와 카본섬유의 혼합비율에 따른 구조체(10)의 강도와 수축률 등을 측정하였으며, 그 결과는 아래의 표 2 및 표 3과 같다.In order to secure sufficient strength of the structure 10, the present inventors injection molded the structure by mixing a mixture of glass fiber (GF) and carbon fiber (carbon fiber, CF) to polycaprolactone having a molecular weight of 35,000 After molding by each, the strength and shrinkage of the structure 10 according to the mixing ratio of glass fiber and carbon fiber was measured, and the results are shown in Table 2 and Table 3 below.
GF 혼합율GF mixing rate 중량%weight% 00 1010 2020 3030 5050 6060 7070
인장강도The tensile strength kgf/㎠kg f / ㎠ 175175 312312 345345 378378 395395 412412 395395
modulusmodulus kgf/㎠kg f / ㎠ 5,1995,199 13,89013,890 18,32418,324 23,52723,527 28,87328,873 32,58032,580 34,14734,147
충격강도Impact strength kgf/㎠kg f / ㎠ 6.86.8 11.211.2 13.513.5 14.214.2 14.314.3 13.713.7 7.67.6
수축률Shrinkage % % 1.51.5 0.80.8 0.80.8 0.70.7 0.60.6 0.50.5 0.50.5
유동성liquidity Spiral FlowSpiral flow Cm 5959 5252 4646 4141 3434 2727 1414
MIMI g/10ming / 10min 5454 4242 3737 3131 2424 1818 22
위의 표 2(유리섬유의 혼합비에 따른 기계적 강도 실험결과)에서 유리섬유는 평균 4mm 길이의 섬유가 사용되었으며, 유리섬유의 혼합비가 증가할수록 인장강도 등의 기계적 물성이 급격히 증가하면서 수축률도 감소하는 것을 알 수 있는데, 유리섬유의 함량이 60중량%를 초과하는 경우 기계적 물성은 우수하지만 유동성이 나빠지게 되어 가공온도를 10~20℃ 증가시켜야 원활한 가공이 이루어질 수 있기 때문에 사출성형을 위한 재료로서는 적합하지 않으며, 따라서 폴리카프로락톤(PCL) 내에 약 10∼60 중량%의 유리섬유가 포함되는 경우 구조체(10)에 필요한 기계적 강도와 수축률이 확보되는 동시에 사출성형에 적합한 물성이 확보된다는 것을 알 수 있다.In Table 2 (mechanical strength test results according to the mixing ratio of glass fibers), the average length of the glass fiber was 4mm, and as the mixing ratio of glass fibers increases, mechanical properties such as tensile strength increase rapidly and shrinkage decreases. When the content of glass fiber exceeds 60% by weight, the mechanical properties are excellent, but the fluidity becomes poor, so it is suitable as the material for injection molding because smooth processing can be achieved by increasing the processing temperature by 10 ~ 20 ℃. Therefore, when about 10 to 60% by weight of glass fiber is included in the polycaprolactone (PCL), it can be seen that the mechanical strength and shrinkage rate required for the structure 10 are secured and the physical properties suitable for injection molding are secured. .
CF 혼합율CF mixing rate 중량%weight% 00 1010 2020 3030 5050 6060 7070
인장강도The tensile strength kgf/㎠kg f / ㎠ 175175 324324 335335 391391 437437 455455 462462
modulusmodulus kgf/㎠kg f / ㎠ 5,1995,199 15,52415,524 20,12720,127 27,59827,598 33,25133,251 37,74837,748 39,32039,320
충격강도Impact strength kgf/㎠kg f / ㎠ 6.86.8 13.513.5 17.617.6 20.220.2 22.422.4 21.221.2 21.821.8
수축률Shrinkage % % 1.51.5 0.70.7 0.60.6 0.60.6 0.50.5 0.50.5 0.50.5
유동성liquidity Spiral FlowSpiral flow Cm 5959 5353 4848 4545 3636 2828 1717
MIMI g/10ming / 10min 5454 4545 3838 3333 2525 2121 66
위의 표 3(카본섬유의 혼합비에 따른 구조체의 기계적 강도 실험결과)은 카프로락톤(PCL)에 평균 6mm 길이의 카본섬유를 혼합한 경우에 있어서의 혼합비에 따른 구조체의 기계적 물성의 변화를 실험한 결과를 나타낸 것으로, 유리섬유에서와 같이 카본섬유의 혼합비가 증가할수록 인장강도 등의 기계적 물성이 급격히 증가하면서 수축률도 감소하는 것을 알 수 있으며, 특히 강도 보강재로서 카본섬유를 사용하는 경우 동일 함량의 유리섬유를 사용할 때보다 약 10% 정도의 기계적 강도가 증가하는 것을 확인할 수 있다.Table 3 (mechanical strength test results of the structure according to the mixing ratio of carbon fibers) shows the change in the mechanical properties of the structure according to the mixing ratio in the case of mixing carbon fiber having an average length of 6mm to caprolactone (PCL) The results show that as the mixing ratio of carbon fiber increases, as in glass fiber, mechanical properties such as tensile strength increase rapidly and shrinkage decreases. In particular, when carbon fiber is used as a strength reinforcing material, glass having the same content It can be seen that the mechanical strength is increased by about 10% than when using the fiber.
그리고 구조체(10) 내에 카본섬유의 함량이 60 중량% 초과하는 경우 기계적 물성은 우수하지만 유동성이 나빠 사출성형을 위한 재료로서는 적합하지 않고, 따라서 카프로락톤 복합재 내에 약 10∼60 중량%의 카본섬유가 포함되는 경우 구조체에 필요한 기계적 강도와 수축률이 확보되는 동시에 사출성형에 적합한 물성이 확보된다.In addition, when the content of carbon fiber in the structure 10 exceeds 60% by weight, the mechanical properties are excellent, but the fluidity is poor, so it is not suitable as a material for injection molding, and thus, about 10 to 60% by weight of carbon fiber is contained in the caprolactone composite. When included, the mechanical strength and shrinkage rate required for the structure are secured and the physical properties suitable for injection molding are secured.
그리고 본 발명의 캐스트 원료에는 결정성 고분자인 카프로락톤의 결정 성장속도를 촉진시키기 위해 핵제가 포함될 수 있는데, 이러한 핵제를 사용하는 경우 실제 사출성형 작업시 용융된 구조체 원료(폴리머)가 금형의 내부에서 냉각될 때 높은 온도에서부터 결정화가 일어나게 되고, 그 결과 폴리머가 빨리 고화(固化)됨으로써 냉각시간이 짧아져 성형시간을 단축시킬 수 있는데, 본 발명자 등은 핵제의 종류에 따른 결정화 온도와 냉각시간 등을 조사하기 위해, 핵제의 종류를 바꾸어 가면서 분자량 35,000의 폴리카프로락톤에 평균 4mm 길이의 유리섬유가 30중량% 포함된 폴리머에 한 가지 종류의 핵제를 혼합한 폴리머를 사용하여 단면의 형상은 폭 3mm, 높이 4mm의 사각형으로 이루어지고, 성형된 형상은 그물 형상인 구조체(10)를 성형한 다음, 핵제의 종류에 따른 결정화 온도, 냉각시간 및 유동성 등을 시험하였으며, 그 실험결과는 아래의 표 4와 같고 이때 사용된 핵제는 칼슘카보네이트, 탈크, 소듐벤조에이트, MBS, DMBS 또는 DEBS이며, 핵제 사용량은 칼슘카보네이트와 탈크는 각각 폴리카프로락톤에 대해 1중량%의 비율로 혼합되었고, 소듐벤조에이트, MBS, DMBS 그리고 DEBS는 각각 폴리카프로락톤에 대해 0.1중량%의 비율로 혼합되었다.And the cast material of the present invention may include a nucleating agent to promote the crystal growth rate of the crystalline polymer caprolactone, in the case of using such a nucleating agent melted structure raw material (polymer) in the mold during the actual injection molding operation When cooled, crystallization occurs from a high temperature, and as a result, the polymer solidifies quickly, so that the cooling time can be shortened and the molding time can be shortened. The present inventors have described the crystallization temperature and cooling time according to the type of nucleating agent. In order to investigate, the cross-sectional shape was 3 mm in width, using a polymer containing one kind of nucleating agent mixed with a polymer containing 30 wt% of polycaprolactone having a molecular weight of 35,000 and glass fiber having an average length of 4 mm while changing the type of nucleating agent. It is made of a rectangle of 4mm in height, and the molded shape is a net-shaped structure 10, and then the nucleus species The crystallization temperature, cooling time and fluidity were tested according to the test results. And talc were each mixed at a ratio of 1 wt% based on polycaprolactone, and sodium benzoate, MBS, DMBS and DEBS were mixed at a ratio of 0.1 wt% based on polycaprolactone, respectively.
실험에 있어서 결정화 온도는 ASTM D3418에 의거하여 DSC(differential scanning calorimeter, 시차주사열량계)로 측정하였으며, 고화시간은 성형작업시간을 예측하는 방안으로 일정크기의 시편을 70℃의 항온조에 60초간 담궜다가 꺼낸 후 작업이 가능할 때까지의 시간을 측정하였고, 시간측정은 캐스트 시술경험이 있는 5명의 석고사들이 각 시편을 5회 테스트하여 작업 가능한 시간을 측정한 후 평균값을 계산한 것이다.In the experiment, the crystallization temperature was measured by differential scanning calorimeter (DSC) according to ASTM D3418, and the solidification time was a method of predicting the molding work time. The time until after work was possible was measured, and the time measurement was performed by five gypsum yarns who had cast treatment experience to test each specimen five times, and then calculated the average time.
또한 금형냉각시간은 형체력 90톤 사출기를 사용하여 수지 용융온도 130℃, 사출압력 50%, 금형냉각온도 15℃의 조건에서 사출후 시편을 금형에서 취출하여 시편이 고화되는 최소의 냉각시간을 측정한 것이다.In addition, the mold cooling time was measured using a 90-ton injection molding machine to measure the minimum cooling time after the specimen was removed from the mold after injection under conditions of a resin melting temperature of 130 ℃, injection pressure of 50%, and mold cooling temperature of 15 ℃. will be.
항목Item 단위unit nonenone 칼슘카보네이트Calcium carbonate 탈크Talc Na-BZNa-BZ DEBSDEBS MBSMBS DMBSDMBS
용융점Melting point 6262 6262 6262 6262 6262 6262 6262
결정화 온도Crystallization temperature 2525 3333 3535 3636 3838 3636 3939
금형냉각시간Mold Cooling Time secsec 115115 7575 7474 6565 6363 6868 6161
수축률Shrinkage %% 0.70.7 0.60.6 0.60.6 0.70.7 0.70.7 0.60.6 0.60.6
고화시간 Solidification time secsec 210210 165165 160160 152152 147147 154154 153153
유동성liquidity Spiral FlowSpiral flow Cm 5757 5555 5454 5555 5757 5656 5656
MIMI g/10ming / 10min 5151 5757 5050 5050 4848 5858 4545
위의 표 4(핵제의 종류에 따른 구조체의 물성 실험결과)에서 어떤 종류의 핵제를 사용하든 핵제를 사용하지 않은 경우에 비해 결정화 온도가 8℃ 상승하여 냉각시간과 고화시간이 대폭 단축되고, 그러함에도 유동성은 그대로 유지되며, 또한 제품성형시 싸이클 타임을 단축시켜 생산성을 향상시킬 수 있음을 알 수 있고, 따라서 장시간의 싸이클타임으로 인한 성형 문제점을 해결할 수 있다.In the above Table 4 (testing results of the structure according to the type of nucleating agent), the crystallization temperature is increased by 8 ° C compared to the case of using no nucleating agent, which significantly reduces the cooling time and the solidification time. In addition, the fluidity is maintained as it is, and also it can be seen that it is possible to improve the productivity by shortening the cycle time during product molding, thus solving the molding problem due to long cycle time.
구조체(10)의 외주면에 사출 성형에 의해 부착되는 외피(20)는 앞서 설명한 바와 같이 구조체(10)의 과도한 변형을 방지할 수 있도록 적절한 두께를 가지는 동시에 적절한 강도를 가져야 하며, 또한 완충재로서 기능하여야 한다.The outer shell 20 attached by injection molding to the outer circumferential surface of the structure 10 should have an appropriate thickness and proper strength to prevent excessive deformation of the structure 10 as described above, and should also function as a cushioning material. do.
이에 따라 본 발명자 등은 이러한 기능을 가지는 재질의 외피재를 도출해내기 위해 그물 형상의 구조체(10)의 외주면에 여러 가지의 경도를 가지는 네오프렌 고무, TPE(thermoplastic elastomer) 고무, SEBS(styrene ethylene butylene styrene)고무 또는 실리콘으로 이루어진 외피재(20)를 이중 사출방식에 의해 각각 성형하여 테스트해 본 결과, 외피재로서 네오프렌 고무, TPE고무, SEBS고무를 사용하든 아니면 실리콘을 사용하든 그 물성에 있어서 차이는 유의한 것이 없었고, 다만 경도에 따라 물성에 있어서 차이가 발견되었는데 네오프렌 고무, TPE 고무, SEBS 고무 또는 실리콘의 경도가 낮은 경우, 예를 들면 Shore D 경도가 2보다 낮은 경우 구조체가 과도하게 변형되는 것을 방지하는 기능이 약하고, 이에 반해 Shore D 경도 40과 같이 경도가 Shore D 경도 35보다 큰 경우 과변형 방지 기능은 우수하지만 피부와 닿았을 때 감촉이 나쁠 뿐만 아니라 변형성도 나쁘게 되어 캐스트를 환부에 시술할 때 신체의 굴곡에 따라 쉽게 변형시켜 설치할 수 없게 되는 것을 확인하였으며, 따라서 본 발명에서는 외피재로서 2~35 범위의 Shore D 경도를 가지는 고무 재질 또는 실리콘을 사용한다.Accordingly, the present inventors, such as neoprene rubber, TPE (thermoplastic elastomer) rubber, SEBS (styrene ethylene butylene styrene) having various hardness on the outer circumferential surface of the mesh-like structure 10 to derive the shell material of the material having such a function As a result of molding and testing the outer shell material 20 made of rubber or silicon by double injection method, the difference in physical properties, whether neoprene rubber, TPE rubber, SEBS rubber or silicon is used as the outer shell material There was no significant difference, but there was a difference in the properties according to the hardness. However, when the hardness of neoprene rubber, TPE rubber, SEBS rubber or silicone is low, for example, when Shore D hardness is lower than 2, the structure is excessively deformed. If the hardness is greater than Shore D hardness 35, such as Shore D hardness 40 The function is excellent, but not only bad touch and deformability when in contact with the skin was confirmed that when the cast is applied to the affected part can not be easily deformed and installed according to the body's curvature, accordingly in the present invention 2 ~ Use rubber or silicone with a Shore D hardness in the 35 range.
한편, 폴리카프로락톤은 고가의 폴리머인 동시에 분자량이 크기 때문에 무게가 무거우며, 따라서 본 발명자 등은 구조체(10)에 폴리에틸렌(PE, polyethylene), 폴리프로필렌(PP, polypropylene), 폴리부텐(PB, polybutene), 폴리우레탄(PU, polyurethane), 폴리에틸렌프탈레이트(Polyethylene terephthalate) 등의 합성수지를 첨가하는 경우의 물성을 파악하기 위해 폴리카프로락톤에 상기의 합성수지를 각각 블랜딩하여 실험하였으며, 그 결과는 표 5와 같다. 본 실험은 표 4의 실험에서 사용된 분자량 35,000의 폴리카프로락톤에 4mm의 유리섬유 30중량%와 20중량%의 합성수지가 블랜딩된 폴리머를 이용하여 사출시편을 제작하여 물성과 성형성을 측정하였다. On the other hand, polycaprolactone is expensive because it is an expensive polymer and a large molecular weight, and thus the inventors of the present invention, such as polyethylene (PE, polyethylene), polypropylene (PP, polypropylene), polybutene (PB, In order to understand the physical properties of polybutene), polyurethane (PU, polyurethane), and polyethylene terephthalate, the synthetic resins were blended with polycaprolactone, respectively. same. In this experiment, injection specimens were prepared using a polymer blended with 30 wt% of 4mm glass fiber and 20 wt% of synthetic resin in polycaprolactone having a molecular weight of 35,000 used in the experiments of Table 4 to measure physical properties and formability.
그리고 폴리카프로락톤에 각각의 합성수지를 블랜딩할 때 폴리카프로락톤은 메트릭스(matrix)로 기능하고, 블랜딩되는 합성수지는 도메인(domain)으로 기능하도록 합성수지의 함량(폴리카프로락톤에 대해 약 20중량%)을 각각 조절하였으며, 이에 의해 환자의 환부에 캐스트를 시술하기 위해 캐스트를 가열하였을 때 가열 온도가 합성수지의 융점에 도달하지 못한 경우에도 그물 구조의 캐스트는 변형시킬 수 있다.When blending each synthetic resin to polycaprolactone, polycaprolactone functions as a matrix, and the blended synthetic resin functions as a domain so that the content of synthetic resin (about 20% by weight relative to polycaprolactone) may be used. Each was adjusted so that the cast of the mesh structure could be deformed even when the heating temperature did not reach the melting point of the resin when the cast was heated to perform a cast on the affected part of the patient.
합성수지Synthetic resin 단위unit nonenone PEPE PPPP PBPB PUPU PETPET
가공온도Processing temperature 170170 180180 220220 200200 200200 280280
냉각시간Cooling time secsec 115115 120120 170170 160160 160160 290290
인장강도The tensile strength kgf/㎠kg f / ㎠ 385385 368368 374374 357357 376376 379379
modulusmodulus kgf/㎠kg f / ㎠ 24,25124,251 23,85723,857 24,11024,110 23,05223,052 24,18524,185 24,85024,850
충격강도Impact strength kgf/㎠kg f / ㎠ 13.713.7 14.214.2 12.612.6 13.013.0 14.114.1 13.513.5
고화시간 Solidification time secsec 210210 293293 278278 305305 307307 272272
실험결과, 위의 표 5(합성수지 블랜딩에 따른 구조체의 물성 실험결과)에서 확인할 수 있는 바와 같이 폴리카프로락톤에 다른 합성수지를 블랜딩하더라도 인장강도, 굴곡강도(modulus), 충격강도 등의 기계적 물성에 있어서는 유의한 차이가 발견되지 않았고, 합성수지의 종류에 따라 가공온도와 냉각시간 등의 가공성도 큰 차이를 보이지 않았으나, 다만 폴리에틸렌프탈레이트(PET)의 경우는 가공 온도가 높아져 냉각시간이 길어지는 것이 단점이 있으나, 기계적물성이 우수하여 높은 강도를 요구하는 경우 유용한 것으로 확인되었다. Experimental results, as can be seen in Table 5 (Test results of the physical properties of the composite resin blending), even if the polycaprolactone is blended with other synthetic resins in terms of mechanical properties such as tensile strength, modulus, impact strength No significant difference was found, and the processability of processing temperature and cooling time did not show a big difference according to the type of synthetic resin.However, in case of polyethylene phthalate (PET), the cooling time is long due to high processing temperature. It has been found to be useful when high strength is required due to excellent mechanical properties.
따라서 구조체(10)를 성형하기 위한 폴리머로서 폴리에틸렌, 폴리프로필렌, 폴리부텐은 상대적으로 경량이면서도 가격이 저렴하고, 폴리우레탄 또는 폴리에틸렌테레프탈레이트는 가격이 저렴하여 상기의 합성수지 중 어느 한 가지 이상의 합성수지가 블랜딩된 폴리카프로락톤을 사용하는 경우 기계적 물성은 그대로 유지되면서도 가볍고, 또한 가격이 저렴한 캐스트를 제조할 수 있다.Therefore, polyethylene, polypropylene, and polybutene as polymers for forming the structure 10 are relatively lightweight and inexpensive, and polyurethane or polyethylene terephthalate is inexpensive, thus blending any one or more of the above synthetic resins. In the case of using polycaprolactone, it is possible to produce a cast that is light and inexpensive while maintaining mechanical properties.
한편 위에서는 구조체(10)의 외부를 둘러싸는 외피(20)를 제조할 때 사출성형에 의해 제조하는 것으로 설명하였으나, 이와 같이 외피(20)를 사출 성형에 의해 제조하지 않고 바인더와 고무 용액의 혼합액이 담긴 저장조에 구조체(10) 전체를 담갔다 꺼냄(딥핑, dipping)으로써 외피(20)를 성형하거나, 또는 고무재질이나 실리콘 재질의 한 쌍의 시트를 상하로 배치하고, 이들 시트 사이에 구조체(10)를 위치시킨 상태에서 상하 시트를 초음파 융착 또는 열융착 방식에 의해 융착(시트 융착)시킴으로써 외피(20)를 성형할 수도 있다.On the other hand, the above described as manufacturing by the injection molding when manufacturing the outer shell 20 surrounding the outside of the structure 10, as described above, the outer shell 20 is not produced by the injection molding mixture of the binder and the rubber solution The outer shell 20 is formed by dipping and dipping the entire structure 10 in the reservoir, or a pair of sheets of rubber or silicon is placed up and down, and the structure 10 is interposed between these sheets. The outer shell 20 may be molded by fusion (sheet fusion) of the upper and lower sheets by ultrasonic welding or thermal fusion in the state where) is placed.
이상 설명한 바와 같이 본 발명은 캐스트의 골격을 이루는 구조체가 강도가 보강된 폴리카프로락톤 복합재로 이루어지고, 이러한 구조체를 연질의 외피가 감쌈으로써 외피가 구조체에 대한 보강재 및 변형 제한요소로 기능함으로써 환부에의 캐스트 시술이 용이하면서도 캐스트의 적절한 강도가 담보된다.As described above, the present invention is made of a polycaprolactone composite having a reinforced structure of the cast skeleton, and the soft skin is wrapped around the structure to function as a reinforcement and deformation limiting factor for the structure to the affected part The cast procedure is easy and ensures the proper strength of the cast.

Claims (7)

  1. 환자의 골절 부위 등의 신체를 감싸 고정하는 캐스트에 있어서,In the cast to wrap and fix the body, such as the fracture site of the patient,
    상기 캐스트는 폴리카프로락톤 복합재로 이루어지며, 다각 형상의 개구가 반복적으로 형성됨으로써 그물 형상을 가지는 구조체(10)와; 상기 구조체(10)의 외주면에 부착되는 외피(20)로 이루어지고,The cast is made of a polycaprolactone composite, the structure having a net shape by repeatedly forming a polygonal opening; It consists of an outer shell 20 attached to the outer peripheral surface of the structure 10,
    상기 구조체(10)를 이루는 폴리카프로락톤 복합재의 융점은 50~80℃의 범위를 가지며, The melting point of the polycaprolactone composite constituting the structure 10 has a range of 50 ~ 80 ℃,
    상기 외피(20)는 2~35 범위의 Shore D 경도를 가지는 고무재질 또는 실리콘으로 이루어지는 것을 특징으로 하는 캐스트.The shell 20 is cast, characterized in that made of rubber or silicon having a Shore D hardness in the range of 2 ~ 35.
  2. 청구항 1에 있어서, The method according to claim 1,
    상기 구조체(10)를 이루는 폴리카프로락톤 복합재는 분자량 20,000~ 80,000 범위의 폴리카프로락톤을 포함하는 것을 특징으로 하는 캐스트.The polycaprolactone composite constituting the structure (10) is cast characterized in that it comprises a polycaprolactone in the range of 20,000 to 80,000 molecular weight.
  3. 청구항 1에 있어서, The method according to claim 1,
    상기 그물 형상의 구조체(10)는 사출 성형 또는 압축 성형에 의해 성형되고, 상기 구조체(10)의 외주면에 부착되는 상기 외피(20)는 상기 구조체(10)가 금형의 내부에 설치된 상태에서 사출 성형이 이루어지는 인서트 사출에 의해 성형되는 것을 특징으로 하는 캐스트.The mesh-shaped structure 10 is molded by injection molding or compression molding, and the shell 20 attached to the outer circumferential surface of the structure 10 is injection-molded with the structure 10 installed inside the mold. Cast formed by insert injection is made.
  4. 청구항 1에 있어서, The method according to claim 1,
    상기 그물 형상의 구조체(10)는 사출 성형 또는 압축 성형에 의해 성형되고, 상기 구조체(10)의 외주면에 부착되는 상기 외피(20)는 열융착 또는 딥핑 방식에 의해 성형되는 것을 특징으로 하는 캐스트.The net-shaped structure (10) is molded by injection molding or compression molding, the outer casing (20) attached to the outer circumferential surface of the structure (10) is cast, characterized in that formed by heat fusion or dipping method.
  5. 청구항 1에 있어서, The method according to claim 1,
    상기 폴리카프로락톤 복합재에는 폴리에틸렌, 폴리프로필렌, 폴리부텐, 폴리우레탄, 폴리에틸렌프탈레이트 중 어느 하나 이상의 합성수지가 블랜딩에 의해 첨가되는 것을 특징으로 하는 캐스트.The polycaprolactone composite is cast, characterized in that any one or more synthetic resins of polyethylene, polypropylene, polybutene, polyurethane, polyethylene phthalate is added by blending.
  6. 청구항 1 또는 청구항 2에 있어서,The method according to claim 1 or 2,
    상기 폴리카프로락톤 복합재에는 유리섬유 또는 카본섬유로 이루어진 강도 보강재가 혼합되고, 상기 강도 보강재는 상기 카프로락톤 복합재에 대해 10∼60 중량% 혼합되는 것을 특징으로 하는 캐스트.The polycaprolactone composite is a strength reinforcement made of glass fiber or carbon fiber is mixed, the strength reinforcement is cast characterized in that 10 to 60% by weight relative to the caprolactone composite.
  7. 청구항 1 내지 청구항 5 중 어느 한 항에 있어서, The method according to any one of claims 1 to 5,
    상기 폴리카프로락톤 복합재에는 칼슘카보네이트, 탈크, 소듐벤조에이트, MBS, DMBS 및 DEBS 중 어느 한 개 이상의 핵제가 첨가되는 것을 특징으로 하는 캐스트.The polycaprolactone composite is a cast, characterized in that at least one nucleating agent of calcium carbonate, talc, sodium benzoate, MBS, DMBS and DEBS is added.
PCT/KR2015/006516 2014-07-11 2015-06-25 Thermoplastic cast with excellent transformability and rigidity. WO2016006848A1 (en)

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