KR100435238B1 - 의료용쌕 - Google Patents

의료용쌕 Download PDF

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Publication number
KR100435238B1
KR100435238B1 KR1019960041960A KR19960041960A KR100435238B1 KR 100435238 B1 KR100435238 B1 KR 100435238B1 KR 1019960041960 A KR1019960041960 A KR 1019960041960A KR 19960041960 A KR19960041960 A KR 19960041960A KR 100435238 B1 KR100435238 B1 KR 100435238B1
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South Korea
Prior art keywords
polymer
styrene
matrix
ethylene
medical
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KR1019960041960A
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English (en)
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KR19980022702A (ko
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니콜라 토마스
크라이쉐르 토마스
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프레세니우스 악티엔게젤샤프트
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Publication of KR19980022702A publication Critical patent/KR19980022702A/ko
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Publication of KR100435238B1 publication Critical patent/KR100435238B1/ko

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed
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    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/76—Making non-permanent or releasable joints
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    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
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    • B29C66/3472—General aspects dealing with the joint area or with the area to be joined using particular temperature distributions or gradients; using particular heat distributions or gradients in the plane of the joint, e.g. along the joint line in the plane of the joint or perpendicular to the joint line in the plane of the joint
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    • C08L23/04—Homopolymers or copolymers of ethene
    • C08L23/08—Copolymers of ethene
    • C08L23/0807—Copolymers of ethene with unsaturated hydrocarbons only containing more than three carbon atoms
    • C08L23/0815—Copolymers of ethene with aliphatic 1-olefins
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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Abstract

의료용 빈 쌕이 가열 살균되며 매트릭스-페이즈-폴리머-시스템으로 이루어진다.
121℃에서 가열 살균된 후에 이 쌕의 내측 표면이 서로 붙지 않는다.

Description

의료용 쌕{medical sack}
본 발명은 하나의 챔버와 관형상의 하나의 연결 피스를 가진 의료용 쌕(medical sack)에 관한 것이다.
열가소성 재료로 이루어진 쌕이 일반적으로 비어 있는 상태에서는 가열 살균될 수 없는데, 최적의 웰딩(welding) 특성을 가지는 상기 쌕의 내측 표면이 종종 가열 살균 때문에 내측에서 맞닿고 심지어는 붙어버리기 때문이다. 약 121℃의 온도에서 일반적인 가열 증기 살균시에 그와 같은 쌕의 내측 표면의 접착이 일반적인 현상이므로, 액체가 압력 상승 시에 쌕 챔버에 제공되는 경우, 이 쌕에 단지 적은 액체만이 채워질 수 있다. 그럼에도 불구하고 그와 같은 압력 처리를 통해서도 단단하게 붙은 접착 지점이 떨어지지 않는다.
접착 표면이 커지는 것을 막기위해, 쌕 호일(foil)이 지금까지는 기계적으로 예비 처리되었다. 그러므로, 예를 들어 상기 표면이 거칠게 만들어졌거나 또는 표면에 불룩한 지점이 생기게 처리된, 예를 들어 점 형상의 융기부, 홈, 웨브(web)가생기게 처리되었다. 그럼에도 불구하고 이는 상기 내측 표면에서 작은 표면이 여전히 서로 붙는 결과를 가져오므로, 이 영역들이 채움 과정에서 떨어진다.
US-A 32 11 144에서, 상기 내측 표면 중 적어도 하나가 롤러의 이용을 통해 그에 상응하게 형성된 표면과 함께 거칠게 형성되어, 예를 들어 상기 내측 표면의 상호 달라붙는 밀착성이 예방된다. 이 표면을 거칠게 하기 위한 또다른 방법으로서 에칭(etching) 또는 샌드 블라스트(sand blast)가 이용되므로, 더 이상 상기 내측 표면이 접착되지 않는다.
그러나, 상기 호일 표면의 그와 같은 종류의 처리는 시간과 비용이 매우 많이 든다.
따라서, 의료용 쌕들은 여전히 주로 살균 전에 공기 또는 물과 같은 액체로 또는 이용되는 의료용 액체로 채워져 가열 살균이 실시되는 방식으로 가열 살균 처리된다. 그런 종류의 방법은 EP-Al-0 114 964에 공개되어 있다. 상기 명세서에는 의료 용기가 설명되어 있으며, 이것을 폴리머 혼합물로 이루어진 호일의 웰딩을 통해 형성된다. 살균 전에 이 용기는 공기, 물 또는 의료용 액체로 채워진다.
본 발명의 목적은 가열 살균 후에 비워져 있는 상태에서 내부에서 서로 접하지 않는 내측 표면 또는 접착되지 않는 표면을 가지며, 심지어는 이 쌕의 호일이 기계적으로 예비 처리되거나 또는 융기된 부분을 가지지 않는 의료용 쌕을 제공하는데 있다. 또한 본 발명의 목적은 가열 살균 후에 채워져 있지 않는 상태에서 직접 빈 쌕으로서 이용될 수 있는 의료용 쌕을 제공하는데 있다.
제1도 : 본 발명에 따른 쌕의 개략도.
상기 목적은 청구항 1을 통해 달성된다. 본 발명의 유리한 실시예들은 청구항 2-6에 제공되어 있다.
놀라운 것은 DE 44 10 876에 설명된 매트릭스-페이즈-폴리머-시스템(matrix-phase-Polymer-system)이 상기 호일의 그외 예비 처리 없이 비어있는 상태에서 가열 살균되는 의료용 쌕으로 되며, 이 경우 살균 후에 상기 내측 표면이 서로 접착하지 않는 것이 확인되었다.
그에 따라서 그와 같은 의료용 쌕이 비뇨기과 또는 복막투석(peritonealdialyse)에서 방출(drainage)-목적으로 이용될 수 있는 것이 유리하다. 이와 같은 쌕은 살균되어야 하는 것이 일반적인데, 이것이 튜브 라인 및 도뇨관에 의해 환자의 신체와 연결되므로, 상기 쌕의 오염이 건강을 위험하게 할 수 있다.
상기 쌕의 제조를 위해 바람직하게는 소위 중공 성형- 또는 튜브 호일이 이용된다.
이것은 경우에 따라서 접힐 수도 있으며 상기 외층 가장자리의 2개 측면에, 즉 양 개구에서 웰딩되어야 한다. 그러나, 개개의 호일 시트의 이용 역시 생각해 볼 수 있지만, 이것은 에워싸며 웰딩되어야 한다. 이러한 호일은 또한 실링 층(sealing layer)이 되기도 하는 적어도 내측의 층(inner layer)에 있어서는 기본적으로 메트릭스 폴리머(a matrix Polymer) 및 페이저 폴리머(a phase polymer)로 이루어진 2개의 성분(components)을 가진다. 매트릭스- 및 페이저 폴리머 시스템은본 명세서에서 매트릭스-페이저 폴리머 시스템(the matrix-phase polymer system)으로 명해진다. 이러한 매트릭스-페이저 폴리머 시스템은 몇몇 매우 특별한 폴리머에 제한되고 또한 폴리머 조성물에 제한된다.
폴리에틸렌-호모폴리머(Polyethylene homopolymer) , 폴리프로필렌-호모폴리티(polypropylene-homopolymer) 및 폴리프로필렌-코폴리머(polyprolene-copolymer)와 같은 높은 여기(excitation) 또는 용융(melting) 온도 범위를 가진 폴리머가 매트릭스 폴리머로서 사용될 수 있다. 폴리에틸렌은 고밀도 플리에틸렌(high density Polyethylene:HDPE)로서 사용된다. 상기 언급된 폴리머 중에서, 폴리프로필렌 코폴리머가 적절하다. 특별히, 폴리프로필레 랜덤 코폴리머(a polyprophylene random copolymer)가 보다 적절하다.
스티렌 에틸렌/부틸렌 스티렌 블록 폴리머(styrene ethylene/butylene styrene block polymer:SEBS), 스티렌 에틸렌/프로필렌 스틸렌 블록 폴리머(SEPS), 및/또는 스티렌 이소프렌 스티렌 트리블록 폴리머(styrene isoprene styrene triblock polymer:SIS)와 같은 마찬가지로 높은 여기 범위(a likewise high excitation range)를 가진 폴리머만이 페이저 폴리머로서 사용될 수 있다.
스티롤-에틸렌-부틸렌-블록-코폴리머가 이용되는 것이 바람직하다. 상기 폴리머 층에서 페이즈-폴리머의 성분은 이 때, 상기 전체 매트릭스-페이즈-폴리머-시스템과 관련하여, 1내지 40 중량 %의 범위에 있다.
매트릭스폴리머가 폴리프로필렌을 포함하는 것이 선호된다. 이 매트릭스-폴리머가 60-95 중량 %의 양에서 존재하는 것이 유리하다. 또한, 페이즈-폴리머로서스티롤-에틸렌-부틸렌-스티롤-블록-폴리머(SEBS) 또는 스티롤-에틸렌-프로필렌-스티롤-블록-폴리머(SEPS)가 선호되고, 이것은 2-40 중량 %에 존재한다. 이 페이즈 폴리머는 100000g/mol 이상의 분자량을 가지며 근본적인 디블록 성분을 가지지는 않는다.
이 외측 가장자리 영역의 웰딩 자리는 적어도 하나의 챔버에서 연결 피스로서 적어도 하나의 지지부를 가지며, 이 경우 이 지지부는 인렛 지지부이다.
상기 쌕은 걸이 장치(hanger)를 포함할 수도 있다.
본 발명에 따른 의료용 빈 쳄버 쌕의 제조 방법은 외측 가장 자리 영역에서의 웰딩은 웰딩 영역의 찢어짐 또는 쌕의 파손이 허용되지 않은 그러한 온도에서 이루어지는 것을 특징으로 한다.
이 웰딩 프로세스의 기간은 1 내지 8초의 범위가 바람직하며 웰딩 프로세스 동안 웰딩되는 영역에서 작용한 평면 프레싱은 0.1 내지 3N/mm2의 범위인 것이 바람직하다. 그러나 상기 양 파라미터에 대해 상기 범위 밖에 있는 값들 역시 가능하다. 그러므로, 상기 양 파라미터들을 선호되는 범위에 국한되지 않는다.
본 발명의 그외 세부 사항들, 특징들 및 장점들은 도면을 이용하는 실시예의 하기 설명에 제공되어 있다.
제1도에는 하나의 챔버(12)를 가진 쌕(10)이 도시되어 있다. 이 쌕(10)은 중공 성형된 호일로 형성되어 있으므로, 상측 가장자리 영역(14)과 하측 가장자리 영역(16)이 웰딩된다. 이 가장자리 영역(16)에 연결 피스(18)가 웰딩되어 있으며, 이것은 관 형상으로 형성되어 상기 챔버(12)와의 흐름 연결부의 기능을 제공한다.
이 연결 피스(18)는 도시되어 있지 않은 튜브 또는 기판 연결 피스와 연결될 수 있다.
상측 가장자리는 걸이 개구(20)(걸 수 있는 구멍)를 가지므로, 상기 쌕(10)이 필요한 경우 걸릴 수 있다.
이 쌕 호일은 압출-중공 성형된 호일 장치에서 제조된다.
다음의 중공 성형 호일이 제조된다.
121℃ 이상의 연화점을 가지는 85 중량% PP-호모폴리머(BASF의 Novelen 3200 HX)가 15 중량% SEBS(Shell의 krateon G 1650)와 혼합되어 중공 성형 호일 장치에서 중공 성형 호일로 가공된다.
그 때문에 상기 중공 성형 호일은 상기 쌕의 길이에 상응하게 절단되어 제1도에 도시된 것처럼, 쌕(10)으로 만들어진다. 이 때 상기 웰딩 영역(14와 16)은 약 140℃에서 웰딩된다.
그와 같은 종류의 쌕은 상온의 3-4ℓ 물을 채워 2m 높이에서 떨어뜨려도 터지지 않는다. 마찬가지로 이것은 충진물의 조절을 위한 투명성을 충족시킨다.
이런 특성이 충족되는 한, 실제적인 호일 구조는 가변적이 될 수 있고 가열살균의 요구되는 특성이 접착 또는 점착 경향 없이 페이즈 매트릭스-폴리머 시스템의 이용에 의존한다.
이 호일의 강도는 그의 두께에 의존한다. 이것은 일반적으로 0.1-0.3mm의 범위에 있으며 필요한 경우 이 한계 밖에 있을 수도 있다.
이렇게 만들어진 쌕(10)은 일반적으로 빈 쌕으로서 CAPD-튜브 시스템에의 내장에 적합하다. 이것은 튜브 라인에 의해 환자의 복막 투석 도뇨관에 연결되며 이런 이유로 절대적으로 살균이 이루어져야 한다. 그 때문에 상기 전체 시스템은 하나의 쌕에 설치되어 가열 살균 장치에서 121℃로 가열 살균된다.

Claims (9)

  1. 적어도 하나의 쳄버(12), 적어도 하나의 관 형상의 연결 피스(one tubular connection)(18) 및 가장자리 영역(14, 16)이 전체적으로 웰딩된(be weldedthrough) 의료용 쌕에 있어서,
    상기 쌕의 호일 내측 표면은 매트릭스-페이즈-폴리머 시스템(matrix phase polymer system)을 포함하고, 쌕의 내측 표면은 미리 기계적으로 열처리되지(mechanically preheated) 않고 또한 융기된 영역(raised areas)을 가지지 않으면서 서로 접착되지 않는 것을 특징으로 하는 비어 있는 상태에서 열-살균하는 것에 의하여 얻어질 수 있는 채워지지 않는 열-살균된 빈 의료용 쌕(an unfilled heat-sterilized empty medical sack)(10).
  2. 청구항 1에 있어서,
    상기 매트릭스-페이저-폴리머-시스템의 메트릭스 폴리머는 폴리에틸렌 호모폴리머(a polyethylene homepolymer), 폴리프로필렌 호모 폴리머(a polypropylene homopolymer) 또는 폴리프로필렌 코폴리머(a polypropylene copolymer) 인 것을 특징으로 하는 채워지지 않는 열-살균된 빈 의료용 쌕.
  3. 청구항 2에 있어서,
    상기 매트릭스 폴리머는 폴리프로필렌 코폴리머인 것을 특징으로 하는 채워지지 않는 열 살균된 빈 의료용 쌕.
  4. 청구항 1에 있어서,
    상기 매트릭스-페이저-폴리머 시스템의 페이저 폴리머는 스티렌-에틸렌/부틸렌-스티렌-크트리-블록-폴리머(a styrene ethylene/butylene styrene triblock polymer:SEBS) ,스티렌-에틸렌/부틸렌-디블록부분(a styrene ethylene/butylene diblockfraction:SEB)을 가진
    스티렌-에틸렌/부틸렌-스티렌-트리블록-폴리머(SEBS), 스티렌-에틸렌/프로필렌-스티렌-트리블록-폴리머(SEPS) , 스티렌-부타디엔-스티렌-트리블록-폴리머(SBS) 및/또는 스티렌-이소프렌-스티렌-트리블록-폴리머(SIS) 및/또는 에틸렌-알파-올레핀-코폴리머(an ethylene-α -olefin-copolymer) 인 것을 특징으로 하는 채워지지 않는 열 살균된 빈 의료용 쌕.
  5. 청구항 1 내지 4 중 어느 하나에 있어서,
    상기 폴리머 시스템에 있는 페이저 폴리머 부분은 매트릭스-페이저-폴리머 시스템과 관련하여 1 내지 40 중량%인 것을 특징으로 하는 채워지지 않는 열 살균된 빈 의료용 쌕.
  6. 청구항 1 내지 4 중 어느 하나에 있어서,
    상기 쌕의 호일(foil)은 다중층(multilayer)이고 압출성형(coextruded)된 것을 특징으로 하는 채워지지 않는 열 살균된 빈 의료용 쌕.
  7. 청구항 3에 있어서,
    상기 폴리프로필렌-코폴리머는 폴리프로필렌-랜덤-코폴리머(a polypropylene random copolymer) 인 것을 특징으로 하는 채워지지 않는 열 살균된 빈 의료용 쌕.
  8. 청구항 5에 있어서,
    폴리머 시스템에 있는 페이저 폴리머 부분은 매트릭스-페이저-폴리머 시스템과 관련하여 10 내지 20 중량%인 것을 특징으로 하는 채워지지 않는 열 살균된 빈 의료용 쌕.
  9. 의료용 쌕의 외부 가장자리 부분(14, 16)의 웰딩은 의료용 쌕이 파괴되지 않는다면 웰딩된 영역이 찢어져서 열려질 수 없는 온도에서 수행되는 것을 특징으로 하는 청구항 1 내지 청구항 4 중의 어느 하나에 따른 채워지지 않는 열 살균된 빈 의료용 쌕을 제조하는 방법.
KR1019960041960A 1995-09-29 1996-09-24 의료용쌕 KR100435238B1 (ko)

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US6004636A (en) 1999-12-21
CA2186330C (en) 2008-05-06
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