DK159051B - ELASTOMES ARE USED FOR A MEDICAL INFUSION DEVICE - Google Patents
ELASTOMES ARE USED FOR A MEDICAL INFUSION DEVICE Download PDFInfo
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- DK159051B DK159051B DK025582A DK25582A DK159051B DK 159051 B DK159051 B DK 159051B DK 025582 A DK025582 A DK 025582A DK 25582 A DK25582 A DK 25582A DK 159051 B DK159051 B DK 159051B
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L9/00—Compositions of homopolymers or copolymers of conjugated diene hydrocarbons
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- 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
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/148—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags
- A61M5/152—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags pressurised by contraction of elastic reservoirs
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- Medical Preparation Storing Or Oral Administration Devices (AREA)
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- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Manufacture Of Porous Articles, And Recovery And Treatment Of Waste Products (AREA)
Description
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Den foreliggende opfindelse angår syntetiske polyisopren-blærer til medicinske infusionsapparater, som har forbedret modstandsevne mod spontan, sprængning.The present invention relates to synthetic polyisoprene blisters for medical infusion devices which have improved resistance to spontaneous bursting.
Medicinske apparater, som infuserer væsker i patienter, 5 kaldes infusionsapparater. En type infusionsapparat anvender en elastomer blære som sin kraftkilde. Sådanne infusionsapparater og blærer er beskrevet i de amerikanske patentskrifter nr. 3.993.069 og 4.201.207. Disse infusionsapparater består af et hus, en elastomer blære indeholdt i hu-10 set og opspilet af væske, der skal infuseres, og en ledning, der fører fra blæren til infusionsstedet. Den hastighed, hvormed væsken infuseres fra infusionsapparatet, afhænger af det tryk, som udøves på væsken af blæren, viskositeten af væsken og den modstand mod strømningen, som lednin-15 gen frembyder. De ovennævnte patenter beskriver blærer, der er i stand til at Opretholde trykket på væsken i hovedsagen konstant gennem udtømningen af en stor del af væsken. Blærerne, der er beskrevet i disse patenter, er fremstillet af vulkaniseret syntetisk polyisopren, der har en lavfrekvent 20 hysterese mindre end ca. 10% og en spændingsafslappelse mindre end ca. 10%. Sådanne hysterese-egenskaber og spændingsafslappelses-egenskaber er blevet betragtet som nøglefaktorer for realisering af en i hovedsagen konstant trykudøvelse.Medical devices that infuse fluids in patients, 5 are called infusers. One type of infusion device uses an elastomeric bladder as its source of power. Such infusion devices and blisters are described in U.S. Patent Nos. 3,993,069 and 4,201,207. These infusion devices consist of a housing, an elastomeric bladder contained in the housing and fluid flow to be infused, and a conduit leading from the bladder to the infusion site. The rate at which the liquid is infused from the infusion apparatus depends on the pressure exerted on the fluid by the bladder, the viscosity of the fluid and the resistance to flow that the conduit presents. The aforementioned patents disclose blisters capable of maintaining the pressure of the liquid substantially constantly through the discharge of a large portion of the liquid. The blisters described in these patents are made of vulcanized synthetic polyisoprene having a low-frequency hysteresis less than ca. 10% and a tension relaxation less than approx. 10%. Such hysteresis and voltage relaxation properties have been considered as key factors in achieving a substantially constant pressure exertion.
25 Ved fremstilling af store antal af sådanne blærer af syntetisk polyisopren har det vist sig, at et mindre, men betydningsfuldt antal af dem sprængtes, når de var opspilet, især efter længere tids lagring i opspilet tilstand. Selv om kun en lille del af blærerne sprængtes på denne måde, var det 30 ønskeligt at nedsætte forekomsten af sprængning . De ovennævnte DK 159051 B.25 In the manufacture of large numbers of such blisters of synthetic polyisoprene, it has been found that a smaller but significant number of them burst when played, especially after prolonged storage in the played state. Although only a small fraction of the blisters were ruptured in this way, it was desirable to reduce the incidence of rupture. The aforementioned DK 159051 B.
2 patenter siger intet om at nedsætte forekomsten af blæresprængning.2 patents say nothing about reducing the incidence of blistering.
Opfindelsen angår en elastomer blære som angivet i indledningen til krav 1. Et hovedformål med den foreliggende op-5 findelse er at angive syntetiske polyisoprenblærer, der har nedsat forekomst af sprængning, og som udøver et acceptabelt konstant tryk. Dette opnås ved foranstaltningerne, som er angivet i den kendetegnende del af krav 1.The invention relates to an elastomeric bladder as set forth in the preamble of claim 1. A principal object of the present invention is to provide synthetic polyisoprene blisters which have a reduced incidence of rupture and which exert an acceptable constant pressure. This is achieved by the measures set out in the characterizing part of claim 1.
Som anvendt i den foreliggende beskrivelse betyder betegneΙ-ΙΟ sen "pph" dele pr. 100 dele syntetisk polyisopren.As used in the present specification, the term "pph" means parts per minute. 100 parts synthetic polyisoprene.
Den syntetiske polyisopren, der anvendes til at fremstille blærerne, har ca. 90% - ca. 98% af sine monomere enheder bundne i cis-l,4-orientering. Den er fortrinsvis af den type, der fremstilles ved at anvende Ziegler-katalysatorer, 15 og som er ejendommelig ved at have ca. 96 - ca. 98% cis- 1,4-bindinger. Denne polyisopren blandes homogent med partikelformet siliciumdioxid eller partikelformet carbon black eller blandinger deraf, som har den ovennævnte partikelstørrelse. Fordampet siliciumdioxid foretrækkes. Dette sili= 20 ciumdioxid fremstilles ved hydrolyse af siliciumtetrachlorid-damp i en hydrogen flamme og oxygen ved temperaturer over smeltetemperaturen af siliciumdioxid (ca. 1710 °C). Ved denne forbrændingsproces dannes smeltede kugler af silicium= dioxid, som ved afkøling sammensmelter med andre til dannelse 25 af forgrenede, tredimensionale kædeagtige aggregater. Slutproduktet har typisk et overfladeareal i intervallet fra o ca. 150 til ca. 450 m /gram, målt ved BET-metoden. Disse for-The synthetic polyisoprene used to make the blisters has approx. 90% - approx. 98% of its monomeric units bound in cis-1,4 orientation. It is preferably of the type produced by using Ziegler catalysts, and which is characterized by having approx. 96 - approx. 98% cis-1,4 bonds. This polyisoprene is homogeneously mixed with particulate silica or particulate carbon black or mixtures thereof having the above particle size. Evaporated silica is preferred. This silica = 20 cesium dioxide is produced by hydrolysis of silicon tetrachloride vapor in a hydrogen flame and oxygen at temperatures above the melting temperature of silica (about 1710 ° C). In this combustion process, molten spheres of silicon = dioxide are formed, which upon cooling fuse with others to form branched, three-dimensional chain-like aggregates. The end product typically has a surface area in the range of about 150 to approx. 450 m / gram, measured by the BET method. These
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3 dampede siliciumdioxider forhandles af Cabot Corporation/3 Steamed Silicon Dioxides Negotiated by Cabot Corporation /
Boston/ Massachusetts, under varemærket Cab-O-Sil. Det anvendte carbon black vil typisk have et overfladeareal i 2 intervallet fra ca. 50 til ca. 250 m /gram, målt ved BET-5 metoden. Mængden af siliciumdioxid eller carbon black, som blandes med polyisoprenen, skal være tilstrækkelig til i det væsentlige at hindre spontan sprængning af blæren på grund af spændinger, som forekommer i blærevæggene, når blæren er udspilet med medicinsk væske. Ca. 3 - ca. 10 pph , fortrins-10 vis 3-7 pph siliciumdioxid eller carbon black vil normalt blive blandet med den syntetiske polyisopren. Mindre mængder vil ikke give en betydningsfuld forøgelse i modstandsevnen mod sprængning. Mere end 10 pph kan tilsættes, men disse mængder frembringer ikke tilsvarende større forøgelse af mod-15 standsevnen mod sprængning og kan have en skadelig virkning på den konstanthed, hvormed blæren udøver tryk.Boston / Massachusetts, under the trademark Cab-O-Sil. Typically, the carbon black used will have a surface area in the 2 interval of from about. 50 to approx. 250 m / gram, measured by the BET-5 method. The amount of silica or carbon black mixed with the polyisoprene should be sufficient to substantially prevent spontaneous bursting of the bladder due to tension occurring in the bladder walls when the bladder is flushed with medical fluid. Ca. 3 - approx. 10 pph, preferably 3-7 pph silica or carbon black will usually be mixed with the synthetic polyisoprene. Smaller quantities will not give a significant increase in blast resistance. More than 10 pph may be added, but these amounts do not produce a correspondingly greater increase in resistance to bursting and may have a detrimental effect on the consistency with which the bladder exerts pressure.
Blandingen af polyisopren og siliciumdioxid/carbon black vulkaniseres til dannelse af kulstof-til-kulstof eller monothio-tværbindinger i 1- og 4-stillingerne i isopren-enheden. For 20 at opnå denne vulkanisering tilsættes et vulkaniseringsmiddel til blandingen, og blandingen underkastes vulkaniseringsbetingelser. Vulkaniseringsmidler og fremgangsmåder, der kan anvendes, er beskrevet i amerikansk patent nr. 4.201.207 i spalte 2, linie 54 - spalte 3, linie 13, og i amerikansk 25 patent nr. 3.993.069 i spalte 8, linie 50 - spalte 10, linie 25. Dicumylperoxid tilsat i mængder i intervallet fra ca. 1 til 2 pph er et foretrukket vulkaniseringsmiddel. Vulkaniseringen vil typisk blive udført under formningsprocessen, der anvendes til at fremstille de rørformede legemer af 30 blandingen. En sådan fremgangsmåde indebærer kalandrering af blandingen af polyisopren-siliciumdioxid/carbon black og vulkaniseringsmiddel til et ark og anbringelse af skiveformede segmenter af arket i en overføringsform, som formerThe polyisoprene and silica / carbon black blend is vulcanized to form carbon-to-carbon or monothio cross-links at the 1- and 4-positions of the isoprene unit. To achieve this vulcanization, a vulcanizing agent is added to the mixture and the mixture is subjected to vulcanization conditions. Vulcanizing agents and methods that can be used are described in U.S. Patent No. 4,201,207 in column 2, line 54 - column 3, line 13, and in U.S. Patent No. 3,993,069 in column 8, line 50 - column 10 , line 25. Dicumyl peroxide added in amounts ranging from approx. 1 to 2 pph is a preferred vulcanizing agent. The vulcanization will typically be performed during the forming process used to prepare the tubular bodies of the mixture. Such a process involves calendering the polyisoprene-silica / carbon black mixture and vulcanizing agent into a sheet and placing disc-shaped segments of the sheet in a transfer mold which forms
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4 arket til hule cylindriske rør af den ønskede geometri. Sædvanlig sprøjtestøbningsteknik kan også anvendes til at forme legemet. Støbningstemperaturen, trykket og tiden er således, at der opnås den ønskede vulkanisering (tværbinding) 5 af polyisoprenen. Geometrien af de rørformede legemer er den samme, som er- beskrevet i amerikansk patent nr. 3.993.069, spalte 4, linie 26-41.4 the hollow cylindrical tube sheet of the desired geometry. Conventional injection molding technique can also be used to shape the body. The molding temperature, pressure and time are such that the desired vulcanization (crosslinking) of the polyisoprene is achieved. The geometry of the tubular bodies is the same as described in U.S. Patent No. 3,993,069, column 4, lines 26-41.
Efter at blandingen er formet .til rørformede legemer, ekstra-; 10 heres legemerne med et opløsningsmiddel, som fjerner i hovedsagen alt ureageret vulkaniseringsmiddel og nedbrydningsprodukterne af vulkaniseringsmidlet fra legemet. Opløsningsmidlet skal ikke have nogen Varige skadelige virkninger på legemet og skal ikke efterlade giftige rester i eller på lege-15 met. Det særlige opløsningsmiddel, som anvendes, og ekstraktionstiden og temperaturen afhænger af det vulkaniseringsmiddel, som blev anvendt. Formålet med ekstraktionen er at forhindre forurening af den medicinske væske, som til slut fyldes i blæren, med vulkaniseringsmidlet eller dets nedbryd-20 ningsprodukter.After the mixture is formed into tubular bodies, extra-; 10, the bodies are cured with a solvent which removes substantially all unreacted vulcanizing agent and the degradation products of the vulcanizing agent from the body. The solvent should not have any lasting harmful effects on the body and should not leave toxic residues in or on the body. The particular solvent used and the extraction time and temperature depend on the vulcanizing agent used. The purpose of the extraction is to prevent contamination of the medical fluid which is ultimately filled into the bladder with the vulcanizing agent or its degradation products.
Efter ekstrakten opsuges antioxidanten i legemerne ved at anbringe dem i kontakt med en opløsning af antioxidanten. Anti-oxidanten kommer ind i legemerne, som i reglen er opkvældet flere gange med opløsningsmiddel, ved diffusion. Den mængde 25 antioxidant, som opsuges i et legeme, vil derfor afhænge af legemets diffusions-koefficient over for antioxidanten, koncentrationen af antioxidant i opløsningen, opløseligheden af antioxidanten i legemet, tykkelsen af legemet, ligevægts-kvældnings-rumfanget, som er karakteristisk for kombinationen 30 af elastomer stof og opløsningsmiddel, og betingelserne (tid og temperatur), hvorunder kontakten sker. Fortrinsvis anvendes samme rene opløsningsmiddel til ekstraktionen og opsugningen af antioxidant. Mængden af antioxidant opsuget i lege-After the extract, the antioxidant is absorbed into the bodies by contacting them with a solution of the antioxidant. The antioxidant enters the bodies, which are usually swollen several times with solvent, by diffusion. The amount of antioxidant absorbed in a body will therefore depend on the diffusion coefficient of the body against the antioxidant, the concentration of antioxidant in the solution, the solubility of the antioxidant in the body, the thickness of the body, the equilibrium swelling volume characteristic of the combination. 30 of elastomeric substance and solvent, and the conditions (time and temperature) under which the contact occurs. Preferably, the same pure solvent is used for the extraction and absorption of antioxidant. The amount of antioxidant absorbed in the drug
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5 met skal være tilstrækkelig til at hindre oxidativ nedbrydning (og dermed sprængning) af blæren, i reglen gennem en periode på mindst ca. 1 år. Den mængde, der kræves til at opnå denne opsugning, afhænger af den særligt an-- - 5 . vendte antioxidant. Hvis det drejer sig om de substituerede phe= nol-antioxidanter, der er beskrevet nedenfor, vil der i reglen opsuges ca. 0,2 - ca. 2 pph, fortrinsvis ca. 1 pph.The 5 meter should be sufficient to prevent oxidative degradation (and thus bursting) of the bladder, usually for a period of at least approx. 1 year. The amount required to obtain this suction depends on the particular demand - 5. turned antioxidant. In the case of the substituted phenol antioxidants described below, approx. 0.2 - approx. 2 pph, preferably approx. 1 pph.
Antioxidanter, som er ugiftige, såsom de der er godkendt ' og kommer under titel 21 i The Code of Federal Regulations 10 til brug i kunststoffer, og som anvendes i forbindelse med lægemidler eller næringsmidler, og som er i hovedsagen ikke-udludelige af den medicinske væske, hvormed blæren skal opspiles, kan anvendes. Udtrykket "i hovedsagen ikke-udludelig" betyder, at antioxidanten er mindre end 0,1 vægt% opløselig 15 i den medicinske væske. Ikke-giftige substituerede polyphenol= antioxidanter, såsom tetrakis-[methylen-3-(31,5'-di-t-butyl- 41-hydroxypheny1)-propionat]-methan og l,3,5-trimethyl-2,4,6-tris-(3,5-di-t-butyl-4,4-hydroxybenzyl)-benzen, er foretrukne antioxidanter til brug i opfindelsen. Efter at den ønskede 20 mængde antioxidant er diffunderet ind i legemet, udtages legemet af opløsningen, og opløsningsmidlet fjernes fra legemet, f.eks. ved tørring ved temperaturer op til 50°C. På dette stadium er blæren parat til at blive inkorporeret i infusions-apparatet.Non-toxic antioxidants, such as those approved, and come under Title 21 of The Code of Federal Regulations 10 for use in plastics, used in conjunction with pharmaceuticals or foodstuffs, and which are essentially non-excludable by the medical liquid with which to inflate the bladder may be used. The term "substantially non-excludable" means that the antioxidant is less than 0.1% by weight soluble in the medical fluid. Non-toxic substituted polyphenol = antioxidants such as tetrakis [methylene 3- (31,5'-di-t-butyl-41-hydroxyphenyl) propionate] methane and 1,3,5-trimethyl-2,4, 6-Tris- (3,5-di-t-butyl-4,4-hydroxybenzyl) -benzene are preferred antioxidants for use in the invention. After the desired amount of antioxidant is diffused into the body, the body is withdrawn from the solution and the solvent is removed from the body, e.g. by drying at temperatures up to 50 ° C. At this stage, the bladder is ready to be incorporated into the infusion apparatus.
25 Inkludering af siliciumdioxid eller carbon black og antioxi= dant sammen i blæren nedsætter væsentligt sandsynligheden for, at blæren vil sprænges spontant, når den udspiles. Denne reduktion (eller forøgelse i modstandsevne mod sprængning) kan kvantiseres i forhold til syntetiske polyisopren-blærer, der 30 ikke indeholder siliciumdioxid eller carbon black og anti= oxidant, ved at sammenligne halveringstiden af et antal af de respektive blærer under samme udspilings-betingelser. Halveringstiden er tiden fra opspiling til sprængning af 50% af blærerne. En gruppe på mindst 10 blærer ønskes for at sikre, 35 at resultaterne er statistisk signifikante. Sådanne sammen-The inclusion of silica or carbon black and antioxidant together in the bladder significantly reduces the likelihood that the bladder will spontaneously burst when flushed. This reduction (or increase in crack resistance) can be quantified relative to synthetic polyisoprene blisters which do not contain silica or carbon black and anti-oxidant by comparing the half-life of a number of the respective blisters under the same flushing conditions. The half-life is the time from flushing to blasting 50% of the blisters. A group of at least 10 blisters is desired to ensure that the results are statistically significant. Such
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6 ligninger udført ved 40°C viser, at halveringstiden af blærerne ifølge opfindelsen er mindst 10 gange og typisk mere end 100 gange længere end halveringstiden af blærer, som ikke indeholder siliciumdioxid eller carbon black og anti= 5 oxidant.6 equations performed at 40 ° C show that the half-life of the blisters according to the invention is at least 10 times and typically more than 100 times longer than the half-life of blisters which do not contain silica or carbon black and anti = 5 oxidant.
Det følgende eksempel illustrerer en udførelsesform ifølge opfindelsen.The following example illustrates an embodiment of the invention.
Fremstilling af blanding.Preparation of mixture.
100 dele syntetisk polyisopren (Natsyn 2200, 96% - 98% 10 cis-l,4-bindinger) blev sat til en Farrell laboratoriemølle (15 cm x 32 1/2 cm valser) ved 54 - 6°C , og mellemrummet mellem valserne blev indstillet til 0,20 - 0,225 cm. Efter ca. 3 minutters formaling blev 5,0 pph fordampet silicium= dioxid (Cab-O-Sil M5, 200 - 25 m /gram overfladeareal, _5 15 1,4 x 10 mm nominel gennemsnitsdiameter) sat til møllen i løbet af en periode på 5 minutter. 1,5 pph dicumylperoxid (Di Cup R) blev så sat til blandingen af polyisopren og siliciumdioxid i 4 lige store portioner. Formalingen blev fortsat, indtil der var gået mindst 18 minutter fra det tids-20 punkt, hvor polyisoprenen blev sat til møllen.100 parts of synthetic polyisoprene (Natsyn 2200, 96% - 98% 10 cis-1.4 bonds) were added to a Farrell laboratory mill (15 cm x 32 1/2 cm rolls) at 54 - 6 ° C and the space between the rollers was set to 0.20 - 0.225 cm. After approx. At 3 minutes, 5.0 pph of vaporized silicon = dioxide (Cab-O-Sil M5, 200 - 25 m / gram surface area, 1.5 mm 1.4 x 10 mm nominal average diameter) was added to the mill over a 5 minute period. . 1.5 pph dicumyl peroxide (Di Cup R) was then added to the mixture of polyisoprene and silica in 4 equal portions. The milling was continued until at least 18 minutes had elapsed from the time 20 point when the polyisoprene was added to the mill.
Vulkanisering og støbning.Vulcanization and casting.
Ovennævnte blanding blev fyldt i en overføringsform med 4 hulheder, der blev holdt ved 163 - 166°c, og som havde en indspændingskraft på 25.000 kg. Formhulhederne og dornene var 25 konstrueret til at fremstille hule cylindriske blærer, 75,6 mm . lange, med en 6,63 mm ydre diameter og 5,16 mm indre diameter, og med en integrerende cirkulær flange i hver ende, 1,587 mm bred og 12,7 mm i diameter. Hærdetiden var 20 minutter.The above mixture was filled into a 4-cavity transfer mold maintained at 163 - 166 ° C and having a tensile force of 25,000 kg. The mold cavities and mandrels were designed to produce hollow cylindrical bladders, 75.6 mm. long, with a 6.63 mm outer diameter and 5.16 mm inner diameter, and with an integral circular flange at each end, 1.587 mm wide and 12.7 mm in diameter. The cure time was 20 minutes.
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77
Ekstraktion.Extraction.
Blærer formet og vulkaniseret som ovenfor blev anbragt lodret i ekstraktionsbeholderen i et Soxhlet apparat, der var anbragt på en 1000 ml kolbe. Der blev tilsat tilstrækkelig ethylacetat til at fylde Soxhlet apparatet og til at kunne 5 have 250 ml ethylacetat i kolben. Kolben blev opvarmet, og ekstraktion af blærerne med ethylacetaten blev udført i 4 timer.Blisters formed and vulcanized as above were placed vertically in the extraction vessel of a Soxhlet apparatus placed on a 1000 ml flask. Enough ethyl acetate was added to fill the Soxhlet apparatus and to have 250 ml of ethyl acetate in the flask. The flask was heated and extraction of the blisters with the ethyl acetate was carried out for 4 hours.
Opsugning af antioxidant.Absorption of antioxidant.
En 1,1 vægt% opløsning af l,3,5-trimethyl-2,4,6-tris-(3,4-10 di-t-butyl-4-hydroxybenzyl)-benzen i ethylacetat blev anbragt i en kolbe. Frisk ekstraherede blærer blev anbragt i opløsningen og holdt der ved omgivelsernes temperatur i 4 timer. Forudgående prøver havde vist, at der var en lineær relation mellem vægtprocenten af denne oxidant opsuget i blærerne, 15 idet .0,45% .blev opsuget ved en 1% koncentration, og 0,68% blev opsuget ved en 1,5% koncentration (4 timers opsugnings-tid). Følgelig blev ca. 0,5 pph antioxidant opsuget i blærerne.A 1.1 wt% solution of 1,3,5-trimethyl-2,4,6-tris- (3,4-10 di-t-butyl-4-hydroxybenzyl) -benzene in ethyl acetate was placed in a flask. Freshly extracted blisters were placed in the solution and kept at ambient temperature for 4 hours. Prior tests had shown that there was a linear relationship between the weight percentage of this oxidant absorbed in the bladders, with 0.45% being absorbed at a 1% concentration and 0.68% being absorbed at a 1.5% concentration. (4 hours suction time). Accordingly, approx. 0.5 pph antioxidant absorbed into the bladders.
Undersøgelser af halveringstid.Half-life studies.
20 Prøverne for halveringstid blev udført med blærer fremstillet som ovenfor med undtagelse af, at 1,2 pph tetrakis-[methylen- 3—(31,5 *-di-t-butyl-4'-hydroxyphenyl)-propionat]-methan blev opsuget i blærerne fra en acetone/toluen-opløsning i stedet for den ovenfor beskrevne antioxidant. En gruppe på 24 af 25 disse blærer udspilet med 60 ml vand og holdt i luft ved 40°C havde en halveringstid på ca. 14 måneder. Lignende prøver med grupper af blærer af syntetisk polyisopren fremstillet på i det væsentlige samme måde, men uden siliciumdioxid eller antioxidant, viser, at disse blærer har en halveringstid påThe half-life tests were performed with blisters prepared as above except that 1.2 pph tetrakis- [methylene-3- (31,5 * -di-t-butyl-4'-hydroxyphenyl) propionate] methane was absorbed into the bladders from an acetone / toluene solution instead of the antioxidant described above. A group of 24 of these 25 blisters flushed with 60 ml of water and held in air at 40 ° C had a half-life of approx. 14 months. Similar samples with groups of synthetic polyisoprene blisters made in essentially the same way, but without silica or antioxidant, show that these blisters have a half-life of
Claims (10)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US23732581A | 1981-02-23 | 1981-02-23 | |
| US23732581 | 1981-02-23 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| DK25582A DK25582A (en) | 1982-08-24 |
| DK159051B true DK159051B (en) | 1990-08-27 |
| DK159051C DK159051C (en) | 1991-01-28 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK025582A DK159051C (en) | 1981-02-23 | 1982-01-21 | ELASTOMES ARE USED FOR A MEDICAL INFUSION DEVICE |
Country Status (21)
| Country | Link |
|---|---|
| JP (1) | JPS57156772A (en) |
| AR (1) | AR228472A1 (en) |
| AT (1) | AT386953B (en) |
| AU (1) | AU548485B2 (en) |
| BE (1) | BE892189A (en) |
| BR (1) | BR8200915A (en) |
| CA (1) | CA1213097A (en) |
| CH (1) | CH658194A5 (en) |
| DE (1) | DE3206377A1 (en) |
| DK (1) | DK159051C (en) |
| ES (1) | ES509733A0 (en) |
| FR (1) | FR2502013B1 (en) |
| GB (1) | GB2093473B (en) |
| IE (1) | IE52850B1 (en) |
| IL (1) | IL65081A (en) |
| IT (1) | IT1191167B (en) |
| MX (1) | MX163246B (en) |
| NL (1) | NL189111C (en) |
| NO (1) | NO154181C (en) |
| SE (1) | SE452711B (en) |
| ZA (1) | ZA82268B (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4419096A (en) * | 1982-02-22 | 1983-12-06 | Alza Corporation | Elastomeric bladder assembly |
| CA1241474A (en) * | 1983-01-10 | 1988-08-30 | Robert L. Buchanan | Method of making rubber connectors and other rubber parts for use in human infusion sets and products produced thereby and novel compositions |
| WO1988000841A1 (en) * | 1986-08-08 | 1988-02-11 | Edward John Keogh | Expansible chamber drug infuser system |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1195926A (en) * | 1968-05-08 | 1970-06-24 | Oliver Wallis Burke Jr | Silica Pigment Reinforced Hydrocarbon Rubber Compounded Stocks and Vulcanizates thereof and Processes for Producing the Same. |
| FR2078078A5 (en) * | 1970-02-26 | 1971-11-05 | Pirelli | |
| US4201207A (en) * | 1973-03-26 | 1980-05-06 | Alza Corporation | Bladder for liquid dispenser |
| US3993069A (en) * | 1973-03-26 | 1976-11-23 | Alza Corporation | Liquid delivery device bladder |
| DE2822148C2 (en) * | 1978-05-20 | 1983-02-24 | Chemische Werke Hüls AG, 4370 Marl | Process for the production of a powdery, filler-containing rubber |
-
1982
- 1982-01-08 GB GB8200523A patent/GB2093473B/en not_active Expired
- 1982-01-08 AU AU79406/82A patent/AU548485B2/en not_active Ceased
- 1982-01-15 ZA ZA82268A patent/ZA82268B/en unknown
- 1982-01-21 DK DK025582A patent/DK159051C/en not_active IP Right Cessation
- 1982-01-21 NL NLAANVRAGE8200218,A patent/NL189111C/en not_active IP Right Cessation
- 1982-01-29 AR AR288296A patent/AR228472A1/en active
- 1982-02-10 AT AT0049982A patent/AT386953B/en not_active IP Right Cessation
- 1982-02-10 IT IT67153/82A patent/IT1191167B/en active
- 1982-02-18 SE SE8201009A patent/SE452711B/en not_active IP Right Cessation
- 1982-02-18 BE BE0/207346A patent/BE892189A/en not_active IP Right Cessation
- 1982-02-18 CH CH1027/82A patent/CH658194A5/en not_active IP Right Cessation
- 1982-02-18 ES ES509733A patent/ES509733A0/en active Granted
- 1982-02-19 BR BR8200915A patent/BR8200915A/en not_active IP Right Cessation
- 1982-02-22 NO NO820536A patent/NO154181C/en unknown
- 1982-02-22 DE DE19823206377 patent/DE3206377A1/en active Granted
- 1982-02-22 IE IE370/82A patent/IE52850B1/en not_active IP Right Cessation
- 1982-02-22 CA CA000396781A patent/CA1213097A/en not_active Expired
- 1982-02-23 JP JP57028040A patent/JPS57156772A/en active Granted
- 1982-02-23 IL IL65081A patent/IL65081A/en not_active IP Right Cessation
- 1982-02-23 FR FR828202924A patent/FR2502013B1/en not_active Expired
- 1982-02-25 MX MX191525A patent/MX163246B/en unknown
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PBP | Patent lapsed |