KR950006000B1 - Method for manufaturing of medical tube - Google Patents

Method for manufaturing of medical tube Download PDF

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Publication number
KR950006000B1
KR950006000B1 KR1019920001154A KR920001154A KR950006000B1 KR 950006000 B1 KR950006000 B1 KR 950006000B1 KR 1019920001154 A KR1019920001154 A KR 1019920001154A KR 920001154 A KR920001154 A KR 920001154A KR 950006000 B1 KR950006000 B1 KR 950006000B1
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South Korea
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composition
inner layer
outer layer
medical tube
manufacturing
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KR1019920001154A
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Korean (ko)
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KR930016232A (en
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진원호
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삼성화성공업주식회사
진원호
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Priority to KR1019920001154A priority Critical patent/KR950006000B1/en
Priority to PCT/KR1992/000046 priority patent/WO1993014735A1/en
Priority to DE4294717T priority patent/DE4294717T1/en
Publication of KR930016232A publication Critical patent/KR930016232A/en
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Publication of KR950006000B1 publication Critical patent/KR950006000B1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/03Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
    • B29C48/09Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
    • B29C48/10Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels flexible, e.g. blown foils
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2023/00Tubular articles
    • B29L2023/005Hoses, i.e. flexible
    • B29L2023/007Medical tubes other than catheters

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  • Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Extrusion Moulding Of Plastics Or The Like (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The method for manufacturing medical bag is characterized by comprising forming the interior part with a gel which is gelled at a temperature higher than the gelling temperature for the exterior part, in the manufacture of double-layered cylindrical sheeting of thickness 0.3-0.4mm and width 24-60mm, with diametering compositions of the interior and exterior layers to use a double-layer molding die.

Description

의료용 튜브의 제조방법Manufacturing method of medical tube

본 발명은 혈액채혈 및 보관용이나 생리식염수 보존에 사용되는 합성수지제 의료용 튜브의 제조방법에 관한 것이다.The present invention relates to a method for producing a synthetic resin medical tube used for blood collection and storage or physiological saline preservation.

이와 같은 의료용 튜브를 제조하기 위한 합성수지제 시트는 카렌다 방법에 의해 제조된 시트나 T다이스에 의해 제조된 시트 및 원형다이스에 의해 제조된 시트를 이용할 수 있으나 카렌다 방법에 의한 시트제조나 T다이스 공정에 의한 시트제조는 설비가 대형이어서 무진관리가 어렵고 핀홀 생성률이 많으며 튜브상으로 재접합하여야 하는 결점이 있어 의료용 튜브는 통상 원형다이스에 의해 제조하는 것이 보통이다.Synthetic resin sheet for manufacturing such a medical tube may be used a sheet produced by the calendar method or a sheet manufactured by the T dice and a sheet manufactured by the circular dice, but in the sheet manufacturing or T dice process by the calendar method Due to the large size of the equipment, it is difficult to manage dust-free, have a high rate of pinhole formation, and have defects that need to be rejoined on a tube. Thus, medical tubes are usually manufactured by circular dice.

그런데 원형 다이스에 의해 튜브를 제저하는 경우 설비투자액을 줄일 수 있고 시트상튜브로 제조되므로 시트를 원통형 튜브로 만들기 위한 별도의 공정이 필요치 아니하며, 튜브 내부가 노출되지 아니하므로 먼지등 이물질로부터 보호될 수 있는 등 장점이 있으나 튜브 내면의 점착성으로 인해 튜브가 납작하게 붙어버리므로서 튜브의 일단을 밀봉하고 타단에 호오스를 결합하는 등의 가공작업이 곤란한 결점이 있고, 핀홀의 생성으로 인하여 보존물이 외부로 누출된다던지 바이러스 등의 감염을 일으킬 염려가 있고 투습성으로 인하여 수분이 증발되어 내용물의 조성이 달라져 의료상의 문제가 발생할 염려가 있었다.However, if the tube is made by the circular die, the capital investment can be reduced, and since it is made of a sheet-shaped tube, a separate process for making the sheet into a cylindrical tube is not required. Although it has advantages such as the adhesiveness of the inner surface of the tube, the tube sticks flat and seals one end of the tube and couples the hose to the other end. There is a risk of leaking to the outside or causing an infection, such as a virus, and moisture caused by the moisture permeability evaporated to change the composition of the contents there was a risk of medical problems.

그리하여 튜브를 2중이상의 다층으로 형성시키므로서 핀홀을 폐색시키며 튜브 내층의 점착성을 제거토록 한다던지, 튜브 내면에 실리콘을 도포하거나, 튜브 내면에 세로무늬를 형성시켜 내면벽끼리의 점착과 누출을 방지한 튜브가 개발되기에 이르렀으나 이와 같이 실리콘을 도포한다던지 내면에 세로무늬를 형성시키는 것을 불편하고 또 이러한 방법으로는 핀홀을 제거하고 투습도를 개선하기가 곤란하였다.Thus, the tube is formed into a multilayer of two or more layers, so that pinholes are blocked and adhesiveness of the inner layer of the tube is removed, silicon is applied to the inner surface of the tube, or vertical patterns are formed on the inner surface of the tube to prevent adhesion and leakage between inner walls. Although a tube has been developed, it is inconvenient to apply silicon or to form a vertical pattern on the inner surface, and it is difficult to remove pinholes and improve moisture permeability in this way.

이에 본 발명은 복층성형용 원형다이스를 이용하여 두께 0.3-0.4mm 둘레 24-60cm의 복층 원통형시트를 제조하고 이를 의료용 용기로 사용케 하므로서 핀홀을 폐색시키고 투습도를 낮춰 용기내용물의 수분증발을 억제하였으며, 이에서 나아가 본 발명은 복층으로 형성시키는 원통형시트의 내층을 고용융조성물(Gelation)로 형성시키므로서 내외층을 외층 압축성형 온도조건으로 압출성형시키면 내층은 압출성형온도가 낮아 덜 용융(Gelation)되어 다소성형부족현상이 일어나게 되고 따라서 내부층 표면에 미세한 요철부(Embossing)가 형성하게 하였다. 이와 같이 내부에 요철부가 형성된 원통형 시트는 그 내면에 서로 붙지 아니하여 내면의 점착으로 인한 여러 가지 불편을 해소할 수 있다.Therefore, the present invention manufactured a multilayer cylindrical sheet having a thickness of 0.3-0.4mm and 24-60cm using a double-layered circular die and using it as a medical container, thereby blocking pinholes and lowering the moisture permeability to suppress moisture evaporation of the container contents. In addition, the present invention further forms the inner layer of the cylindrical sheet to be formed into a multi-layer melt-molded composition (Gelation), while the inner and outer layers are extruded under the outer layer compression molding temperature conditions, the inner layer is less melting (Gelation) because the extrusion molding temperature is lower As a result, some molding shortage was caused, and thus fine embossing was formed on the inner layer surface. As such, the cylindrical sheet having the uneven portion formed therein may not adhere to each other on its inner surface, thereby eliminating various inconveniences caused by the inner surface of the cylindrical sheet.

복층으로 된 원통형 시트의 내층을 외층에 비하여 고용융조성물로 형성시킴에 있어서는, 외층을 일반적인 수지조성물로 형성시키고 내층은 이와 같은 일반적인 수지조성물에 비하여 다소 가공온도가 높아지도록 외층부 조성물에 비하여 가소제를 약간 적게 혼합하거나 주원료인 수지의 중합도를 크게 하여 형성시키거나 혹은 니트릴고무(Nytril Rubber)를 혼합시키는 수단이 실시될 수 있으며, 반대로 외층부 조성물에 가소제 함량을 증가시켜 내층 조성물의 용융온도에 비하여 외층의 용융온도가 낮도록 하는 수단이 실시될 수 있다.In forming the inner layer of the multi-layered cylindrical sheet into a solid solution composition as compared with the outer layer, the outer layer is formed of a general resin composition and the inner layer has a plasticizer compared to the outer layer composition so that the processing temperature is somewhat higher than that of the general resin composition. It may be formed by mixing a little less or by increasing the polymerization degree of the main material resin or by mixing nitrile rubber.In contrast, by increasing the plasticizer content in the outer layer composition, the outer layer is compared with the melting temperature of the inner layer composition. Means may be implemented to lower the melting temperature of the.

이와 같은 본 발명을 실시예에 의하여 설명하면 다음과 같다.Referring to the present invention as described above as follows.

[실시예 1]Example 1

내외측 수지조성물을 형성시킴에 있어서 공히 중합도 2000인 PVC 100부량(중량비, 이하 같음), Epoxy화 대두유(O-130P : 상품명, 아사히덴가공업주식회사제품 : 일본국 도오꾜오도 주오구 니혼바시 마라노우찌 2정목)6부량, Ca-Zn 안정제 2부량, 에칠렌 왁스 0.3부량에 가소제인 DOP를 혼가하되, 외층부조성물에는 60부량을, 내층부조성물에는 58부량을 각각 혼가하므로서 내층부의 가소제 혼가량을 2부량 감소시킨 후, 외층부 조성물의 용융압출성형조건(압출기온도 170도, 다이스온도 185도)에 따라 압출 성형하였다.100 parts of PVC having a polymerization degree of 2000 (weight ratio, the same as below), Epoxy-ized soybean oil (O-130P: trade name, Asahi Denki Kogyo Co., Ltd.) Marano Nihonbashi, Too-Odo, Japan 6 parts of Uchi), 2 parts of Ca-Zn stabilizer and 0.3 parts of ethylene wax are mixed with DOP, which is a plasticizer, but 60 parts of the outer layer composition and 58 parts of the inner layer composition are mixed, respectively. After reducing 2 parts by volume, extrusion was carried out according to the melt extrusion molding conditions (extruder temperature 170 degrees, die temperature 185 degrees) of the outer layer portion composition.

이와 같이 하여 내층부 내표면에 미세한 요철이 생기게 하였고 이러한 요철로 인하여 내면끼리의 접합 현상이 생기지 않았다.In this way, minute unevenness was generated on the inner surface of the inner layer, and the unevenness of the inner surfaces did not occur due to the unevenness.

[실시예 2]Example 2

내외층 수지조성물을 형성시킴에 있어서, PVC 100부량에 DOP 60부량, 에폭시화 대두유 5부량, Ca-Zn 안정제 1부량, 왁스 0.2부량을 혼합하되, 외층수지조성물로서의 PVC는 중합도가 1300인 PVC를, 그리고 내층수지조성물로서의 PVC는 중합도가 1700인 PVC를 각각 혼합하여 외층부 수지조성물의 용융압출성형조건(압출기온도 170도, 다이스온도 185도)에 따라 압출성형하였다.In forming the inner and outer resin compositions, 60 parts of DOP, 5 parts of epoxidized soybean oil, 1 part of Ca-Zn stabilizer, and 0.2 parts of wax are mixed with 100 parts of PVC, and PVC as the outer resin composition has PVC having a degree of polymerization of 1300. The PVC as an inner resin composition was mixed with PVC having a polymerization degree of 1700, respectively, and extruded according to the melt extrusion molding conditions (extruder temperature 170 degrees, die temperature 185 degrees) of the outer layer resin composition.

이와 같이 하여 내층부 내표면에 미세한 요철이 생기게 하였고, 이러한 요철로 인하여 내면끼리의 접합현상이 생기지 않았다.In this way, minute unevenness was generated on the inner surface of the inner layer, and the unevenness between the inner surfaces did not occur due to the unevenness.

[실시예 3]Example 3

내외층 수지조성물을 형성시킴에 있어서, PVC(중합도 1800) 100부량에 DOP 55부량,에폭시화 대두유 5부량, Ca-Zn 안정제 1부량, 왁스 0.3부량을 혼합하되, 외층부 조성물에는 PA(아크릴계 가공조제) 2부량을 부가하여 외층부의 용융온도를 저하시키고 저하된 외층부의 용융온도에 대응하여 압출기온도를 170도를 하고 다이스 온도를 185도로 하여 튜브를 압출성형하였다.In forming the inner and outer resin compositions, 55 parts of DOP, 5 parts of epoxy soybean oil, 1 part of Ca-Zn stabilizer, and 0.3 part of wax are mixed with 100 parts of PVC (polymerization degree 1800), but the PA (acrylic processing) is added to the outer layer composition. Preparation) Two parts were added to lower the melting temperature of the outer layer, and the tube was extruded at an extruder temperature of 170 degrees and a die temperature of 185 degrees in response to the lower melting temperature of the outer layer.

[실시예 4]Example 4

내외층 수지조성물을 형성시킴에 있어서, 외측수지조성물 PVC 100부량에 DOP 55부량 에폭시화 대두유 5부량 Ca-Zn 안정제 2부량 왁스 0.2부량을 혼합하여 형성시키되, 외층수지조성물에 있어서의 DOP를 40부량의 니트릴 고무(비용출성 고분자가소제)로 대치하여 내층수지조성물을 형성시키고 압출기 온도 170℃ 다이스온도 185℃로 압출성형하였다. 내층수지조성물에 혼합하는 비용출성 고분자 가소제는 우레탄고무나 에스텔계 가소제(P-200 : 상품명, 아사히덴가제품) 40부량 정도가 바람직하나, 니트릴고무로 대체할 수도 있다.In forming the inner and outer layer resin composition, by mixing 100 parts of the outer resin composition PVC, 55 parts of DOP, 5 parts of epoxidized soybean oil, 2 parts of Ca-Zn stabilizer, and 2 parts of wax, 40 parts of DOP in the outer resin composition Was replaced with a nitrile rubber (non-elutable polymer plasticizer) to form an inner layer resin composition, and extruded at an extruder temperature of 170 ° C and a die temperature of 185 ° C. The non-elutable polymer plasticizer to be mixed with the inner resin composition is preferably about 40 parts by weight of urethane rubber or ester plasticizer (P-200: trade name, Asahi Denga), but may be replaced with nitrile rubber.

본 발명의 제조방법에 의해 제조되는 의료용 튜브는 그 두께가 0.3-0.4mm 폭이 12-30cm인 것이 바람직하다. 이와 같이 내층부는 다소용융온도가 높게 성형되는 물질배합으로 압출성형한 결과 내층은 다소 성형부족현상이 일어나 내층 표면에 미세한 요철이 생기게 되었고 이러한 요철 및 비용출성으로 인하여 내면끼리의 접합현상이 생기지 않았다.It is preferable that the medical tube manufactured by the manufacturing method of this invention is 0.3-0.4mm in width 12-30cm. As such, the inner layer portion was extruded with a material mixture that is somewhat melted at a high melting temperature. As a result, the inner layer was somewhat short of molding, resulting in minute irregularities on the inner layer surface.

Claims (5)

PVC, 가소제, 에폭시화 대두유, 안정제, 왁스등을 혼합한 수지조성물을 압출하여 원통형 시트를 형성시키되, 내외층의 조성을 달리하고, 복층성형용 다이스를 이용하여 두께 0.3-0.4mm, 폭 24-60cm의 복층원통형 시트를 제조함에 있어서, 외층부 조성물의 용융(Gelation)온도보다 높은 온도에서 용융되는 고온용융조성물로서 내층부를 형성시킴을 특징으로 하는 의료용 튜브의 제조방법.Extrude the resin composition mixed with PVC, plasticizer, epoxidized soybean oil, stabilizer, wax, etc. to form a cylindrical sheet, varying the composition of the inner and outer layers, using a die for multilayer molding, 0.3-0.4mm thick, 24-60cm wide The method of manufacturing a medical tube according to claim 1, wherein the inner layer is formed as a hot melt composition which is melted at a temperature higher than the melting temperature of the outer layer composition. 제1항에 있어서, 내층부의 고온 용융조성물은 외층부수지조성물에 혼가하는 양보다 적은 양의 가소제를 혼가하여서 된 것을 특징으로 하는 의료용 튜브의 제조방법.The method for manufacturing a medical tube according to claim 1, wherein the hot melt composition of the inner layer portion is mixed with a plasticizer in an amount less than that of the outer layer resin composition. 제1항에 있어서, 내층부의 고온용융조성물은 외층부의 중합도보다 높은 중합도를 가지는 PVC를 혼합한 것임을 특징으로 하는 의료용 튜브의 제조방법.The method of claim 1, wherein the hot melt composition of the inner layer portion is a mixture of PVC having a polymerization degree higher than that of the outer layer portion. 제1항에 있어서, 외층부의 조성물에 가공조제를 혼가하여 외층부의 용융온도를 저하시키므로서 내층부의 용융온도를 상대적으로 상승시킨 것을 특징으로 하는 의료용 튜브의 제조방법.The method of manufacturing a medical tube according to claim 1, wherein the processing aid is mixed with the composition of the outer layer to lower the melting temperature of the inner layer while relatively increasing the melting temperature of the inner layer. 제1항에 있어서, 내층부를 형성시키는 조성물에 비용출성 고분자 가소제를 첨가하여 외층부에 비하여 다소 용융흐름을 저하시키는 것을 특징으로 하는 의료용 튜브의 제조방법.The method of manufacturing a medical tube according to claim 1, wherein a non-elutable polymer plasticizer is added to the composition forming the inner layer portion to lower the melt flow somewhat compared to the outer layer portion.
KR1019920001154A 1992-01-28 1992-01-28 Method for manufaturing of medical tube KR950006000B1 (en)

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KR1019920001154A KR950006000B1 (en) 1992-01-28 1992-01-28 Method for manufaturing of medical tube
PCT/KR1992/000046 WO1993014735A1 (en) 1992-01-28 1992-10-07 Manufacturing method for medical bag
DE4294717T DE4294717T1 (en) 1992-01-28 1992-10-07 Process for the manufacture of medical bags

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KR950006000B1 true KR950006000B1 (en) 1995-06-07

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