AU2007265010B2 - Medical fluid container - Google Patents
Medical fluid container Download PDFInfo
- Publication number
- AU2007265010B2 AU2007265010B2 AU2007265010A AU2007265010A AU2007265010B2 AU 2007265010 B2 AU2007265010 B2 AU 2007265010B2 AU 2007265010 A AU2007265010 A AU 2007265010A AU 2007265010 A AU2007265010 A AU 2007265010A AU 2007265010 B2 AU2007265010 B2 AU 2007265010B2
- Authority
- AU
- Australia
- Prior art keywords
- fill tube
- container
- container according
- port
- lower portion
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
- 239000012530 fluid Substances 0.000 title claims abstract description 79
- 229920000098 polyolefin Polymers 0.000 claims abstract description 20
- 239000004803 Di-2ethylhexylphthalate Substances 0.000 claims abstract description 5
- BJQHLKABXJIVAM-UHFFFAOYSA-N bis(2-ethylhexyl) phthalate Chemical compound CCCCC(CC)COC(=O)C1=CC=CC=C1C(=O)OCC(CC)CCCC BJQHLKABXJIVAM-UHFFFAOYSA-N 0.000 claims abstract description 5
- 229920005606 polypropylene copolymer Polymers 0.000 claims description 18
- VGGSQFUCUMXWEO-UHFFFAOYSA-N Ethene Chemical compound C=C VGGSQFUCUMXWEO-UHFFFAOYSA-N 0.000 claims description 13
- 239000005977 Ethylene Substances 0.000 claims description 13
- 230000002093 peripheral effect Effects 0.000 claims description 13
- 230000004888 barrier function Effects 0.000 claims description 12
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- 238000002844 melting Methods 0.000 claims description 8
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- 239000000463 material Substances 0.000 description 60
- 239000010408 film Substances 0.000 description 41
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- 238000007789 sealing Methods 0.000 description 28
- 230000000996 additive effect Effects 0.000 description 27
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- 239000004800 polyvinyl chloride Substances 0.000 description 24
- 229920000915 polyvinyl chloride Polymers 0.000 description 23
- 230000000712 assembly Effects 0.000 description 19
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- 238000001990 intravenous administration Methods 0.000 description 16
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- 229920000034 Plastomer Polymers 0.000 description 7
- 229920001577 copolymer Polymers 0.000 description 7
- 238000003780 insertion Methods 0.000 description 7
- 230000037431 insertion Effects 0.000 description 7
- 230000001954 sterilising effect Effects 0.000 description 7
- 238000004659 sterilization and disinfection Methods 0.000 description 7
- 230000000903 blocking effect Effects 0.000 description 6
- 229940079593 drug Drugs 0.000 description 6
- 210000003811 finger Anatomy 0.000 description 6
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- 239000000565 sealant Substances 0.000 description 6
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 6
- 239000004698 Polyethylene Substances 0.000 description 5
- UQMRAFJOBWOFNS-UHFFFAOYSA-N butyl 2-(2,4-dichlorophenoxy)acetate Chemical compound CCCCOC(=O)COC1=CC=C(Cl)C=C1Cl UQMRAFJOBWOFNS-UHFFFAOYSA-N 0.000 description 5
- 239000007924 injection Substances 0.000 description 5
- 238000002347 injection Methods 0.000 description 5
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- 229920000573 polyethylene Polymers 0.000 description 5
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- 229920000642 polymer Polymers 0.000 description 4
- 238000003556 assay Methods 0.000 description 3
- 239000008367 deionised water Substances 0.000 description 3
- 229910021641 deionized water Inorganic materials 0.000 description 3
- 239000003085 diluting agent Substances 0.000 description 3
- 238000001746 injection moulding Methods 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 235000016709 nutrition Nutrition 0.000 description 3
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- 229920005630 polypropylene random copolymer Polymers 0.000 description 3
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- 239000002356 single layer Substances 0.000 description 3
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- 238000012360 testing method Methods 0.000 description 3
- 229920000181 Ethylene propylene rubber Polymers 0.000 description 2
- RRHGJUQNOFWUDK-UHFFFAOYSA-N Isoprene Chemical compound CC(=C)C=C RRHGJUQNOFWUDK-UHFFFAOYSA-N 0.000 description 2
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- 230000009269 systemic vascular permeability Effects 0.000 description 2
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- 241000251468 Actinopterygii Species 0.000 description 1
- 206010001526 Air embolism Diseases 0.000 description 1
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- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 241000282412 Homo Species 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 239000004677 Nylon Substances 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
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- ALSOCDGAZNNNME-UHFFFAOYSA-N ethene;hex-1-ene Chemical compound C=C.CCCCC=C ALSOCDGAZNNNME-UHFFFAOYSA-N 0.000 description 1
- 239000012632 extractable Substances 0.000 description 1
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- 230000005499 meniscus Effects 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 239000008267 milk Substances 0.000 description 1
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Classifications
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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
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- 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
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- A61J1/14—Details; Accessories therefor
- A61J1/1406—Septums, pierceable membranes
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- 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
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- A61J1/14—Details; Accessories therefor
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- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
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- A61J1/18—Arrangements for indicating condition of container contents, e.g. sterile condition
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- 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
- A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
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- 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
- B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
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- 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
- 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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- B29C66/112—Single lapped joints
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- B29C66/128—Stepped joint cross-sections
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- B29C66/128—Stepped joint cross-sections
- B29C66/1286—Stepped joint cross-sections comprising at least one bevelled joint-segment
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- B29C66/131—Single flanged joints, i.e. one of the parts to be joined being rigid and flanged in the joint area
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- B29C66/50—General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
- B29C66/51—Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
- B29C66/53—Joining single elements to tubular articles, hollow articles or bars
- B29C66/532—Joining single elements to the wall of tubular articles, hollow articles or bars
- B29C66/5326—Joining single elements to the wall of tubular articles, hollow articles or bars said single elements being substantially flat
- B29C66/53261—Enclosing tubular articles between substantially flat elements
- B29C66/53262—Enclosing spouts between the walls of bags, e.g. of medical bags
- B29C66/53263—Enclosing spouts between the walls of bags, e.g. of medical bags said spouts comprising wings, e.g. said spouts being of ship-like or canoe-like form to avoid leaks in the corners
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- B29C66/53—Joining single elements to tubular articles, hollow articles or bars
- B29C66/534—Joining single elements to open ends of tubular or hollow articles or to the ends of bars
- B29C66/5344—Joining single elements to open ends of tubular or hollow articles or to the ends of bars said single elements being substantially annular, i.e. of finite length, e.g. joining flanges to tube ends
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- B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
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- B29C66/723—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered
- B29C66/7234—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered comprising a barrier layer
- B29C66/72343—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered comprising a barrier layer for liquids
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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
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- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/201—Piercing means having one piercing end
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- A—HUMAN NECESSITIES
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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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
- A61M39/165—Shrouds or protectors for aseptically enclosing the connector
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
-
- 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
- B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
- B29C65/08—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using ultrasonic vibrations
-
- 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
- B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
- B29C65/14—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
-
- 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
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
- B29C66/71—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the composition of the plastics material of the parts to be joined
-
- 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
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/80—General aspects of machine operations or constructions and parts thereof
- B29C66/83—General aspects of machine operations or constructions and parts thereof characterised by the movement of the joining or pressing tools
- B29C66/832—Reciprocating joining or pressing tools
- B29C66/8322—Joining or pressing tools reciprocating along one axis
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/712—Containers; Packaging elements or accessories, Packages
- B29L2031/7148—Blood bags, medical bags
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Hematology (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Applications Claiming Priority (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/477,061 | 2006-06-28 | ||
US11/477,061 US7527619B2 (en) | 2004-12-23 | 2006-06-28 | Medical fluid container |
US11/477,007 US20060276769A1 (en) | 2004-12-23 | 2006-06-28 | Medical fluid container |
US11/477,007 | 2006-06-28 | ||
US11/496,690 | 2006-07-31 | ||
US11/496,690 US7717897B2 (en) | 2004-12-23 | 2006-07-31 | Medical fluid container with concave side weld |
PCT/US2007/072361 WO2008003045A2 (fr) | 2006-06-28 | 2007-06-28 | Récipient pour fluide médical |
Publications (2)
Publication Number | Publication Date |
---|---|
AU2007265010A1 AU2007265010A1 (en) | 2008-01-03 |
AU2007265010B2 true AU2007265010B2 (en) | 2013-02-28 |
Family
ID=56290985
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
AU2007265010A Expired - Fee Related AU2007265010B2 (en) | 2006-06-28 | 2007-06-28 | Medical fluid container |
Country Status (5)
Country | Link |
---|---|
EP (1) | EP2037830A4 (fr) |
JP (1) | JP2009542367A (fr) |
AU (1) | AU2007265010B2 (fr) |
CA (1) | CA2656488A1 (fr) |
WO (1) | WO2008003045A2 (fr) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2939308B1 (fr) | 2008-12-08 | 2012-04-06 | Technoflex | Recipient souple a usage medical |
JP6564766B2 (ja) * | 2014-03-27 | 2019-08-21 | テルモ株式会社 | 医療用容器 |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4150673A (en) * | 1977-02-03 | 1979-04-24 | Pharmachem Corporation | Coded entry system for blood bag |
US4484916A (en) * | 1982-01-20 | 1984-11-27 | American Hospital Supply Corporation | Medical solution container and port construction |
US5126175A (en) * | 1985-06-14 | 1992-06-30 | Material Engineering Technology Laboratory, Inc. | Medical solution container |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
BE794248A (fr) * | 1972-02-22 | 1973-05-16 | Baxter Laboratories Inc | Perfectionnements apportes aux fermetures steriles pour bouteilles ou flacons a solution |
JPH0448192Y2 (fr) * | 1988-03-28 | 1992-11-13 | ||
DE29515682U1 (de) * | 1995-10-02 | 1995-12-07 | B. Braun Melsungen Ag, 34212 Melsungen | Portsystem für einen Beutel |
US5961914A (en) * | 1996-05-03 | 1999-10-05 | Milliken & Company | Method of thermoforming polyolefin resin |
US6179823B1 (en) * | 1998-01-20 | 2001-01-30 | Bracco Research Usa | Multiple use universal connector flexible medical container assembly |
US6039718A (en) * | 1998-01-20 | 2000-03-21 | Bracco Research Usa | Multiple use universal connector |
JP4675502B2 (ja) * | 2001-05-31 | 2011-04-27 | テルモ株式会社 | 液体収容バッグ |
US7264608B2 (en) * | 2001-12-05 | 2007-09-04 | Fenwal, Inc. | Manual processing systems and methods for providing blood components conditioned for pathogen inactivation |
US7025745B2 (en) * | 2002-10-07 | 2006-04-11 | Advanced Cardiovascular Systems, Inc. | Method of making a catheter balloon using a tapered mandrel |
DE10313760B3 (de) * | 2003-03-27 | 2004-06-03 | Fresenius Kabi Deutschland Gmbh | Konnektor für medizinische Flüssigkeiten enthaltende Verpackungen und Verpackung für medizinische Flüssigkeiten |
-
2007
- 2007-06-28 WO PCT/US2007/072361 patent/WO2008003045A2/fr active Application Filing
- 2007-06-28 CA CA002656488A patent/CA2656488A1/fr not_active Abandoned
- 2007-06-28 EP EP07799133.9A patent/EP2037830A4/fr not_active Withdrawn
- 2007-06-28 AU AU2007265010A patent/AU2007265010B2/en not_active Expired - Fee Related
- 2007-06-28 JP JP2009518556A patent/JP2009542367A/ja active Pending
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4150673A (en) * | 1977-02-03 | 1979-04-24 | Pharmachem Corporation | Coded entry system for blood bag |
US4484916A (en) * | 1982-01-20 | 1984-11-27 | American Hospital Supply Corporation | Medical solution container and port construction |
US5126175A (en) * | 1985-06-14 | 1992-06-30 | Material Engineering Technology Laboratory, Inc. | Medical solution container |
Also Published As
Publication number | Publication date |
---|---|
AU2007265010A1 (en) | 2008-01-03 |
EP2037830A4 (fr) | 2013-11-06 |
CA2656488A1 (fr) | 2008-01-03 |
JP2009542367A (ja) | 2009-12-03 |
EP2037830A2 (fr) | 2009-03-25 |
WO2008003045A3 (fr) | 2008-12-11 |
WO2008003045A2 (fr) | 2008-01-03 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
MK25 | Application lapsed reg. 22.2i(2) - failure to pay acceptance fee |