NO154181B - BLOWING ELASTOMER MATERIAL FOR USE IN A MEDICAL INFUSION DEVICE AND PROCEDURE FOR MANUFACTURING THEREOF - Google Patents
BLOWING ELASTOMER MATERIAL FOR USE IN A MEDICAL INFUSION DEVICE AND PROCEDURE FOR MANUFACTURING THEREOF Download PDFInfo
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- NO154181B NO154181B NO820536A NO820536A NO154181B NO 154181 B NO154181 B NO 154181B NO 820536 A NO820536 A NO 820536A NO 820536 A NO820536 A NO 820536A NO 154181 B NO154181 B NO 154181B
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- polyisoprene
- antioxidant
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- silicon dioxide
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- 229920001971 elastomer Polymers 0.000 title claims description 14
- 239000000806 elastomer Substances 0.000 title claims description 14
- 238000001802 infusion Methods 0.000 title claims description 11
- 238000000034 method Methods 0.000 title claims description 9
- 238000004519 manufacturing process Methods 0.000 title claims description 4
- 238000007664 blowing Methods 0.000 title 1
- 239000000463 material Substances 0.000 title 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 53
- 239000003963 antioxidant agent Substances 0.000 claims description 41
- 230000003078 antioxidant effect Effects 0.000 claims description 37
- 229920001195 polyisoprene Polymers 0.000 claims description 25
- 239000000377 silicon dioxide Substances 0.000 claims description 25
- 235000012239 silicon dioxide Nutrition 0.000 claims description 23
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 claims description 15
- 229920003051 synthetic elastomer Polymers 0.000 claims description 15
- 239000003795 chemical substances by application Substances 0.000 claims description 14
- 239000000203 mixture Substances 0.000 claims description 13
- 239000002904 solvent Substances 0.000 claims description 9
- 239000012633 leachable Substances 0.000 claims description 7
- 231100000252 nontoxic Toxicity 0.000 claims description 7
- 230000003000 nontoxic effect Effects 0.000 claims description 7
- 238000004073 vulcanization Methods 0.000 claims description 6
- 150000008442 polyphenolic compounds Chemical class 0.000 claims description 4
- 235000013824 polyphenols Nutrition 0.000 claims description 4
- XMNIXWIUMCBBBL-UHFFFAOYSA-N 2-(2-phenylpropan-2-ylperoxy)propan-2-ylbenzene Chemical compound C=1C=CC=CC=1C(C)(C)OOC(C)(C)C1=CC=CC=C1 XMNIXWIUMCBBBL-UHFFFAOYSA-N 0.000 claims description 3
- 230000015556 catabolic process Effects 0.000 claims description 3
- CREMABGTGYGIQB-UHFFFAOYSA-N carbon carbon Chemical compound C.C CREMABGTGYGIQB-UHFFFAOYSA-N 0.000 claims description 2
- 239000011203 carbon fibre reinforced carbon Substances 0.000 claims description 2
- 239000006193 liquid solution Substances 0.000 claims description 2
- VSAWBBYYMBQKIK-UHFFFAOYSA-N 4-[[3,5-bis[(3,5-ditert-butyl-4-hydroxyphenyl)methyl]-2,4,6-trimethylphenyl]methyl]-2,6-ditert-butylphenol Chemical compound CC1=C(CC=2C=C(C(O)=C(C=2)C(C)(C)C)C(C)(C)C)C(C)=C(CC=2C=C(C(O)=C(C=2)C(C)(C)C)C(C)(C)C)C(C)=C1CC1=CC(C(C)(C)C)=C(O)C(C(C)(C)C)=C1 VSAWBBYYMBQKIK-UHFFFAOYSA-N 0.000 claims 4
- 125000004464 hydroxyphenyl group Chemical group 0.000 claims 1
- 230000001590 oxidative effect Effects 0.000 claims 1
- 238000000605 extraction Methods 0.000 description 7
- 239000007788 liquid Substances 0.000 description 6
- 239000000243 solution Substances 0.000 description 6
- 239000012530 fluid Substances 0.000 description 4
- YXFVVABEGXRONW-UHFFFAOYSA-N Toluene Chemical compound CC1=CC=CC=C1 YXFVVABEGXRONW-UHFFFAOYSA-N 0.000 description 3
- 238000010521 absorption reaction Methods 0.000 description 3
- 238000005336 cracking Methods 0.000 description 3
- 239000000047 product Substances 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 2
- 238000000354 decomposition reaction Methods 0.000 description 2
- 238000009792 diffusion process Methods 0.000 description 2
- 229910021485 fumed silica Inorganic materials 0.000 description 2
- 238000012423 maintenance Methods 0.000 description 2
- -1 monothio Chemical group 0.000 description 2
- VXEGSRKPIUDPQT-UHFFFAOYSA-N 4-[4-(4-methoxyphenyl)piperazin-1-yl]aniline Chemical compound C1=CC(OC)=CC=C1N1CCN(C=2C=CC(N)=CC=2)CC1 VXEGSRKPIUDPQT-UHFFFAOYSA-N 0.000 description 1
- PDHRHCVPAXDFSC-UHFFFAOYSA-N 4-[[3,5-bis[(3,4-ditert-butyl-4-hydroxycyclohexa-1,5-dien-1-yl)methyl]-2,4,6-trimethylphenyl]methyl]-1,6-ditert-butylcyclohexa-2,4-dien-1-ol Chemical compound CC1=C(CC=2C=CC(O)(C(C(C)(C)C)C=2)C(C)(C)C)C(C)=C(CC=2C=CC(O)(C(C(C)(C)C)C=2)C(C)(C)C)C(C)=C1CC1=CC(C(C)(C)C)C(O)(C(C)(C)C)C=C1 PDHRHCVPAXDFSC-UHFFFAOYSA-N 0.000 description 1
- 238000004438 BET method Methods 0.000 description 1
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 1
- RRHGJUQNOFWUDK-UHFFFAOYSA-N Isoprene Chemical group CC(=C)C=C RRHGJUQNOFWUDK-UHFFFAOYSA-N 0.000 description 1
- 229920004941 NATSYN® 2200 Polymers 0.000 description 1
- 238000000944 Soxhlet extraction Methods 0.000 description 1
- 206010046530 Urinary bladder rupture Diseases 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- UHOVQNZJYSORNB-UHFFFAOYSA-N benzene Substances C1=CC=CC=C1 UHOVQNZJYSORNB-UHFFFAOYSA-N 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 238000003490 calendering Methods 0.000 description 1
- 238000005266 casting Methods 0.000 description 1
- 239000003054 catalyst Substances 0.000 description 1
- 238000002485 combustion reaction Methods 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 238000004132 cross linking Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 230000009931 harmful effect Effects 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 239000001257 hydrogen Substances 0.000 description 1
- 230000007062 hydrolysis Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 238000001746 injection moulding Methods 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- VNWKTOKETHGBQD-UHFFFAOYSA-N methane Natural products C VNWKTOKETHGBQD-UHFFFAOYSA-N 0.000 description 1
- 239000000178 monomer Substances 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 238000006864 oxidative decomposition reaction Methods 0.000 description 1
- 238000010525 oxidative degradation reaction Methods 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- NFHFRUOZVGFOOS-UHFFFAOYSA-N palladium;triphenylphosphane Chemical compound [Pd].C1=CC=CC=C1P(C=1C=CC=CC=1)C1=CC=CC=C1.C1=CC=CC=C1P(C=1C=CC=CC=1)C1=CC=CC=C1.C1=CC=CC=C1P(C=1C=CC=CC=1)C1=CC=CC=C1.C1=CC=CC=C1P(C=1C=CC=CC=1)C1=CC=CC=C1 NFHFRUOZVGFOOS-UHFFFAOYSA-N 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 230000002085 persistent effect Effects 0.000 description 1
- 150000002989 phenols Chemical class 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 239000005049 silicon tetrachloride Substances 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 230000008961 swelling Effects 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Vascular Medicine (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicinal Chemistry (AREA)
- Polymers & Plastics (AREA)
- Organic Chemistry (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Compositions Of Macromolecular Compounds (AREA)
- Materials For Medical Uses (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Manufacture Of Porous Articles, And Recovery And Treatment Of Waste Products (AREA)
Description
Den foreliggende oppfinnelse vedrører en elastomerblære for anvendelse i en medisinsk infusjonsanordning, omfattende et rørformet legeme fremstilt av en vulkanisert syntetisk polyisopren som har 90-98% cis-1,4-bindinger. The present invention relates to an elastomeric bladder for use in a medical infusion device, comprising a tubular body made of a vulcanized synthetic polyisoprene having 90-98% cis-1,4 linkages.
Oppfinnelsen vedrører også en fremgangsmåte til fremstilling av blæra. The invention also relates to a method for producing the bladder.
Medisinske infusjonsanordninger er anordninger som fører inn væsker i pasienter. I en type infusjonsanordning anvendes det en elastomerblære som kraftkilde. Slike infusjonsanordninger og blærer er kjent fra US-patentskrifter 3.993.069 og 4.201.207. Disse infusjonsanordninger består av et hus, en elastomer blære som er anordnet i huset og som fylles med væsken som skal tilførsel, samt en ledning som fører fra blæren til infusjonsstedet. Hastigheten væsken tilføres med fra infusjonsanordningen er avhengig av trykket som utøves på Medical infusion devices are devices that introduce fluids into patients. In one type of infusion device, an elastomer bladder is used as a power source. Such infusion devices and bladders are known from US patents 3,993,069 and 4,201,207. These infusion devices consist of a housing, an elastomeric bladder which is arranged in the housing and which is filled with the liquid to be supplied, as well as a line leading from the bladder to the infusion site. The speed with which the liquid is supplied from the infusion device depends on the pressure exerted on it
væsken av blæren, væskens viskositet og ledningens strømnings-begrensende egenskaper. Fra de ovennevnte patentskrifter er det kjent blærer som er i stand til holde trykket på væsken stort sett konstant under en stor andel av tømmingen i væsken. Blærene som er kjent fra disse patentskrifter er fremstilt av vulkanisert, syntetisk polyisopren som har en lav hysterese-frekvens på under ca. 10% og en spenningsrelaksasjon på under ca. 10%. Slike hysterese- og spenningsrelaksasjonskarakteri-stikker blir ansett som nøkkelfaktorer for å oppnå bibehold av stort sett konstant trykk. the fluid of the bladder, the viscosity of the fluid and the flow-limiting properties of the line. From the above-mentioned patents, bladders are known which are able to keep the pressure on the liquid largely constant during a large proportion of the emptying of the liquid. The bladders known from these patents are made of vulcanized, synthetic polyisoprene which has a low hysteresis frequency of less than approx. 10% and a stress relaxation of less than approx. 10%. Such hysteresis and stress relaxation characteristics are considered key factors in achieving maintenance of substantially constant pressure.
Ved fremstilling av store antall slike blærer av syntetisk polyisopren viste det seg at et lite, men vesentlig antall av dem revnet ved fylling, særlig etter lang lagring i fylt tilstand. Selv om bare et lite antall av blærene revnet slik, var det ønskelig å minske hyppigheten av revning for å oppnå en større sikkerhetsmargin mot revning på markedet. I ovennevnte patentskrifter er det ikke sagt noe om senkning av hyppigheten av blærerevning. When producing large numbers of such bladders from synthetic polyisoprene, it turned out that a small but significant number of them burst when filled, particularly after long storage in a filled state. Although only a small number of the blisters ruptured in this way, it was desirable to reduce the frequency of rupture in order to achieve a greater margin of safety against rupture in the market. In the above-mentioned patent documents, nothing is said about lowering the frequency of bladder rupture.
Formålet med den foreliggende oppfinnelse er å frembringe en blære av syntetisk polyisopran som har særlig lav revnings-hyppighet og akseptabel trykkonstans. The purpose of the present invention is to produce a bladder of synthetic polyisoprene which has a particularly low tear frequency and acceptable pressure constancy.
Blæren ifølge oppfinnelsen er kjennetegnet ved at polyisopren er homogent blandet med partikkelformet silisiumdioksyd som har en nominell gjennomsnittsdiameter i området fra 1 x The bladder according to the invention is characterized by the fact that polyisoprene is homogeneously mixed with particulate silicon dioxide which has a nominal average diameter in the range from 1 x
-5 -3 10 til 5 x 10 mm og som foreligger i mengder fra 3 til 10 deler pr. 100 deler polyisopren, og med en ugiftig, stort sett ikke utvaskbar antioksydant, hvorved mengdene av silisiumdioksyd og antioksydant er tilstrekkelige til å gjøre halveringstiden for et antall blærer ved 40°C minst 10 ganger lenger enn halveringstiden for et sammenliknbart antall blærer fremstilt av den vulkaniserte, syntetiske polyisopren, men uten silisiumdioksyd og antioksydant. -5 -3 10 to 5 x 10 mm and which are available in quantities from 3 to 10 parts per 100 parts polyisoprene, and with a non-toxic, largely non-leachable antioxidant, whereby the amounts of silicon dioxide and antioxidant are sufficient to make the half-life of a number of blisters at 40°C at least 10 times longer than the half-life of a comparable number of blisters produced by the vulcanized , synthetic polyisoprene, but without silicon dioxide and antioxidant.
Fremgangsmåtene til fremstilling av elastomerblæren kjennetegnes ved at blandingen utsettes for vulkaniseringsbetingelser og formes til et rørformet legeme, hvoretter ureagert vulkaniseringsmiddel og nedbrytningsprodukter av vulkaniseringsmidlet løsningsmiddelsekstraheres fra legemet, og diffunderer en ugiftig, stort sett ikke utvaskbar antioksydant inn i legemet ved at det rørformete legeme bringes i kontakt med en flytende løsning av antioksydanten, slik at mengden antioksydant som diffunderes inn i legemet er tilstrekkelig til stort sett å inhibere oksydativ nedbrytning av legemet. The methods for producing the elastomer bladder are characterized in that the mixture is subjected to vulcanization conditions and formed into a tubular body, after which unreacted vulcanizing agent and breakdown products of the vulcanizing agent are solvent extracted from the body, and a non-toxic, largely non-leachable antioxidant diffuses into the body by bringing the tubular body into contact with a liquid solution of the antioxidant, so that the amount of antioxidant that diffuses into the body is sufficient to largely inhibit oxidative degradation of the body.
Det syntetiske polyisopren som anvendes til fremstilling av blærene inneholder 90-98% av sine monomerenheter bundet i cis-1,4-orientering. Den er fortrinnsvis av den type som er fremstilt under anvendelse av Ziegler-katalysatorer og som er kjennetegnet ved at den har 96-98% cis-1,4-bindinger. Denne polyisopren blandes homogent med partikkelformet silisiumdioksyd som har den ovenfor angitte partikkelstørrelse. Fordampet silisiumdioksyd foretrekkes. Slikt silisiumdioksyd fremstilles ved hydrolyse av silisiumtetraklorid-damp i en flamme av hydrogen og oksygen ved temperaturer over smeltetemperaturen for silisiumdioksyd (ca. 1710°C). Under denne forbrennings-prosess dannes det smeltede kuler av silisiumdioksyd som ved avkjøling smelter sammen med hverandre til dannelse av tredimensjonale forgrenete kjedeliknende aggregater. Slutt-produktet har typisk et overflateareal i området fra 150 til 450 m<2>/g målt ifølge BET-metoden. "Cab-O-Sil" er et slikt fordampet silisiumdioksyd. Mindre mengder enn 3 deler silisiumdioksyd vil ikke gi en vesentlig økning i bestandigheten mot revning. Mer enn 10 deler kan tilsettes, men slike kvanta gir ikke tilsvarende større økning av bestandigheten mot revning og kan påvirke blærens bibeholdelse av konstant trykk ugunstig. The synthetic polyisoprene used to manufacture the bladders contains 90-98% of its monomer units bound in cis-1,4 orientation. It is preferably of the type produced using Ziegler catalysts and characterized by having 96-98% cis-1,4 linkages. This polyisoprene is mixed homogeneously with particulate silicon dioxide which has the particle size indicated above. Fumed silica is preferred. Such silicon dioxide is produced by hydrolysis of silicon tetrachloride vapor in a flame of hydrogen and oxygen at temperatures above the melting temperature of silicon dioxide (approx. 1710°C). During this combustion process, molten spheres of silicon dioxide are formed which, on cooling, fuse with each other to form three-dimensional branched chain-like aggregates. The final product typically has a surface area in the range from 150 to 450 m<2>/g measured according to the BET method. "Cab-O-Sil" is one such fumed silicon dioxide. Less than 3 parts silicon dioxide will not give a significant increase in resistance to cracking. More than 10 parts can be added, but such amounts do not give a correspondingly greater increase in the resistance to cracking and may adversely affect the bladder's maintenance of constant pressure.
Polyisopren-silisiumdiooksydbLandingen vulkaniseres, The polyisoprene-silica mixture is vulcanized,
hvorved det dannes karbon-karbon- eller monotio-tverrbindinger i isoprenenhetens 1- og 4-stillinger. For å oppnå slik vulkanisering tilsettes det et vulkaniseringsmiddel til blandingen, og blandingen utsettes for vulkaniseringsbetingelser. Vulkani-seringsmidler og fremgangsmåter som kan benyttes er beskrevet i US-patentskrift 4.201.207 fra spalte 2 linje 54 til spalte 3 linje 13 og i US-patentskrift 3.993.069 fra spalte 8 linje 50 til spalte 10 linje 25. Dicumylperoksyd tilsatt i mengder i området 1-2 deler pr. 100 deler polyisopren er et foretrukket vulkaniseringsmiddel. Vulkaniseringen vil typisk utføres under formingsprosessen som benyttes til fremstilling av de rør-formete legemer fra blandingen. En slik prosess omfatter kalan-dering av blandingen av polyisopren, silisiumdioksyd og vulkaniseringsmiddel til en plate og anbringelse av et skive-formet segment av platen i en transpress-form hvor platen formes til hule, sylindriske rør med ønsket geometri. Vanlige sprøytestøpingsmetoder kan også benyttes til forming av legemet. Støpetemperaturen, trykket og tiden er slik at den ønskete vulkanisering (fornetning) av polyisopren oppnås. Geometrien til de rørformete legemer er den samme som den som er beskrevet i US-patentskrift 3.993.069 i spalte 4 linjer 26-41. whereby carbon-carbon or monothio cross-links are formed in the 1- and 4-positions of the isoprene unit. To achieve such vulcanization, a vulcanizing agent is added to the mixture, and the mixture is subjected to vulcanizing conditions. Vulcanizing agents and methods that can be used are described in US patent document 4,201,207 from column 2 line 54 to column 3 line 13 and in US patent document 3,993,069 from column 8 line 50 to column 10 line 25. Dicumyl peroxide added in quantities in the area of 1-2 parts per 100 parts polyisoprene is a preferred vulcanizing agent. The vulcanization will typically be carried out during the forming process used to produce the tubular bodies from the mixture. Such a process comprises calendering the mixture of polyisoprene, silicon dioxide and vulcanizing agent into a plate and placing a disk-shaped segment of the plate in a transpress mold where the plate is formed into hollow, cylindrical tubes of the desired geometry. Normal injection molding methods can also be used to shape the body. The molding temperature, pressure and time are such that the desired vulcanization (cross-linking) of polyisoprene is achieved. The geometry of the tubular bodies is the same as that described in US Patent 3,993,069 in column 4 lines 26-41.
Etter at blandingen er formet til rørformete legemer ekstraheres legemene med et løsningsmiddel som fjerner stort sett alt ureagert vulkaniseringsmiddel og dekomponerings-produktene av vulkaniseringsmidlet fra legemet. Løsningsmidlet bør ikke ha vedvarende skadelige virkninger på legemet og bør ikke etterlate en toksisk rest i eller på legemet. Det spesielle løsningsmiddel som anvendes og ekstraksjonstiden og After the mixture is formed into tubular bodies, the bodies are extracted with a solvent which removes substantially all unreacted vulcanizing agent and the decomposition products of the vulcanizing agent from the body. The solvent should not have persistent harmful effects on the body and should not leave a toxic residue in or on the body. The particular solvent used and the extraction time and
-temperaturen vil avhenge av vulkaniseringsmidlet som ble -the temperature will depend on the vulcanizing agent used
anvendt. Formålet med ekstraksjonen er å hindre forurensning av den medisinske væske, som senere innføres i blæren, med vulkaniseringsmidlet eller dettes dekomponeringsprodukter. used. The purpose of the extraction is to prevent contamination of the medical liquid, which is later introduced into the bladder, with the vulcanizing agent or its decomposition products.
Etter ekstraksjonen absorberes antioksydanten i legemene ved å anbringe dem i kontakt med en løsning av antioksydanten. Antioksydanten trenger inn i legemene, som vanligvis, er svelt atskillige ganger med løsningsmiddel, ved diffusjon. Mengden antioksydant som absorberes i et legeme vil følgelig avhenge av legemets diffusjonskoeffisient overfor antioksydanten, konsen-trasjonen av antioksydanten i løsningen, antioksydantens løselighet i legemet, legemets tykkelse, likevektsvellevolumet som er karakteristisk for elastomer-løsningsmiddelkombina-sjonen, samt av betingelsene (tid og temperatur) som be-røringene utføres under. Fortrinnsvis anvendes samme rene løsningsmiddel for ekstraksjonen og antioksydantabsorpsjonen. Mengden antioksydant som absorberes i legemet bør være tilstrekkelig til å inhibere oksydativ dekomponeringen (og derved rivning) av blæren over et tidsrom på minst 1 år. Mengdene som er nødvendig for å oppnå slik inhibering vil avhenge av den spesielle antioksydant som anvendes. For substituerte fenol-antioksydanter som er beskrevet nedenfor vil det vanligvis absorberes 0,2-1, fortrinnsvis ca. 1 del pr. 100 deler polyisopren. Antioksydanter som er ugiftige, slik som de som er godkjent og under bestemmelsene i kapittel 21 i Code of Federal Regulations for anvendelse i plast som anvendes i forbindelse med legemidler eller matvarer og som er stort sett ikke ut-vaskbare av den medisinske væske som blæren skal fylles med, kan anvendes. Med "stort sett ikke utvaskbar" menes at antioksydanten er mindre enn 0,1 vekt% løselig i den medisinske væske. Ugiftige, substituerte polyfenolantioksydanter, såsom tetrakis [-metylen-3-(3',5'-di-tert-butyl-41-hydroksy-fenyl)propionatj-metan og 1,3,5-trimetyl-2,4,6-tri(3,5-di-tert-butyl-4-4-hydroksybenzyl)-benzen er foretrukne antioksydanter for anvendelse ifølge oppfinnelsen. Etter at den ønskete mengde antioksydant har diffundert inn i legemet, tas legemet ut av løsningen, og løsningsmidlet fjernes fra legemet, f.eks. ved tørking ved temperaturer på opp til 50°C. I dette stadium er blæren klar til å anbringes i infusjonsanordningen. After the extraction, the antioxidant is absorbed into the bodies by placing them in contact with a solution of the antioxidant. The antioxidant penetrates 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 body's diffusion coefficient towards the antioxidant, the concentration of the antioxidant in the solution, the solubility of the antioxidant in the body, the thickness of the body, the equilibrium swelling volume which is characteristic of the elastomer-solvent combination, as well as on the conditions (time and temperature ) under which the touches are performed. Preferably, the same pure solvent is used for the extraction and the antioxidant absorption. The amount of antioxidant absorbed into the body should be sufficient to inhibit the oxidative decomposition (and thereby tearing) of the bladder over a period of at least 1 year. The amounts necessary to achieve such inhibition will depend on the particular antioxidant used. For substituted phenol antioxidants described below, 0.2-1, preferably approx. 1 part per 100 parts polyisoprene. Antioxidants that are non-toxic, such as those approved and under the provisions of Chapter 21 of the Code of Federal Regulations for use in plastics used in connection with drugs or foodstuffs and that are generally not leachable from the medical fluid that the bladder is to be filled with, can be used. By "largely non-leachable" is meant that the antioxidant is less than 0.1% by weight soluble in the medicinal liquid. Non-toxic, substituted polyphenol antioxidants, such as tetrakis[-methylene-3-(3',5'-di-tert-butyl-41-hydroxy-phenyl)propionatej-methane and 1,3,5-trimethyl-2,4,6- tri(3,5-di-tert-butyl-4-4-hydroxybenzyl)-benzene are preferred antioxidants for use according to the invention. After the desired amount of antioxidant has diffused into the body, the body is removed from the solution, and the solvent is removed from the body, e.g. when drying at temperatures of up to 50°C. At this stage, the bladder is ready to be placed in the infusion device.
Anvendelsen av silisiumdioksyd og antioksydanten nedsetter sammen vesentlig sannsynligheten for at blæren vil revne spontant når den fylles. Denne nedsettelse (eller økning i bestandighet mot revning ) kan kvantiseres i forhold til blærer av syntetisk polyisopren som ikke inneholder silisiumdioksyd og antioksydant ved å sammenlikne halveringstiden for antall av de respektive blærer under samme fyllebetingelser. Halveringstiden er tidsrommet fra blærene fylles til 50% av dem er revnet. Et antall på minst 10 blærer er ønsket for å sikre at resultatene er statistisk riktige. Slike sammenlikninger som er utført ved 40°C viser at halveringstiden for blærene ifølge oppfinnelsen er minst 10 ganger, og typisk mer enn 100 ganger, lengre enn halveringstiden for blærer som ikke inneholder silisiumdioksyd og antioksydant. The use of silicon dioxide and the antioxidant together significantly reduces the probability that the bladder will rupture spontaneously when it is filled. This reduction (or increase in resistance to cracking) can be quantified in relation to bladders of synthetic polyisoprene that do not contain silicon dioxide and antioxidant by comparing the half-life for the number of the respective bladders under the same filling conditions. The half-life is the time from when the bladders are filled until 50% of them are ruptured. A number of at least 10 blisters is desired to ensure that the results are statistically correct. Such comparisons carried out at 40°C show that the half-life for the blisters according to the invention is at least 10 times, and typically more than 100 times, longer than the half-life for blisters that do not contain silicon dioxide and antioxidant.
Det etterfølgende eksempel viser en utførelsesform av oppfinnelsen. The following example shows an embodiment of the invention.
Fremstilling av blanding Preparation of mixture
100 deler syntetisk polyisopren ("Natsyn 2200", 96-98% cis-1,4-bindinger) ble anbrakt i en Farrell laboratoriumsmølle, som hadde valser på 15,2 x 33 cm, ved 54 + 6°C, og spalten mellom valsene ble justert til 2-2,3 mm. Etter ca. 3 minutters formaling ble 5,0 deler fordampet silisiumdioksyd ("Cab-O-Sil" 100 parts of synthetic polyisoprene ("Natsyn 2200", 96-98% cis-1,4 linkages) was placed in a Farrell laboratory mill, which had rolls of 15.2 x 33 cm, at 54 + 6°C, and the gap between the rollers were adjusted to 2-2.3 mm. After approx. 3 minutes of grinding became 5.0 parts fumed silica ("Cab-O-Sil"
2 -5 2 -5
,M5, 200 + 25 m /g overflateareal, 1,4 x 10 mm nominell gjennomsnittlig diameter) pr. 100 deler polyisopren tilsatt til møllen over et tidsrom på 5 minutter. 1,5 deler dicumylperoksyd (Di Cup R) pr. 100 deler polyisopren ble deretter tilsatt til blandingen av polyisopren og silisiumdioksyd i 4 like store porsjoner. Formaling ble fortsatt inntil minst 18 minutter var gått fra tidspunktet da polyisoprenen ble anbrakt i møllen. ,M5, 200 + 25 m /g surface area, 1.4 x 10 mm nominal average diameter) per 100 parts polyisoprene added to the mill over a period of 5 minutes. 1.5 parts dicumyl peroxide (Di Cup R) per 100 parts polyisoprene was then added to the mixture of polyisoprene and silica in 4 equal portions. Forming was continued until at least 18 minutes had passed from the time the polyisoprene was placed in the mill.
Vulkanisering og støping Vulcanization and casting
Overnevnte blanding ble anbrakt i en transpress-form som hadde fire hulrom og som ble holdt på 163-166°C og hadde en lukkekraft på 25.000 kg. Formhullene og dorene var utformet slik at det ble dannet hule, sylindriske blærer som var 7 5,6 mm lange med ytre diameter på 6,63 mm og indre diameter på 5,16 mm og med en sirkelrund flens i hver ende, som var 1,587 mm bred og 12,7 mm i diameter. Herdetiden var 20 minutter. The above mixture was placed in a transpress mold which had four cavities and which was maintained at 163-166°C and had a closing force of 25,000 kg. The die holes and mandrels were designed to form hollow cylindrical bladders 7 5.6 mm long with an outer diameter of 6.63 mm and an inner diameter of 5.16 mm and with a circular flange at each end, which was 1.587 mm wide and 12.7 mm in diameter. The curing time was 20 minutes.
Ekstrahering Extraction
Blærer som var fremstilt og vulkanisert slik som beskrevet ovenfor ble anbrakt vertikalt i ekstraksjons-beholderen i et Soxhlet-ekstraksjonsapparat, som var anbrakt på en 1000 ml kolbe. Tilstrekkelig etylacetat ble tilført til å fylle Soxhlet-apparatet og har 250 ml etylacetat i kolben. Kolben ble oppvarmet, og ekstraksjon av blærene med etylacetat ble utført i 4 timer. Blisters prepared and vulcanized as described above were placed vertically in the extraction vessel of a Soxhlet extraction apparatus, which was placed on a 1000 ml flask. Sufficient ethyl acetate was added to fill the Soxhlet apparatus and have 250 mL of ethyl acetate in the flask. The flask was heated and extraction of the vesicles with ethyl acetate was carried out for 4 hours.
Absorpsjon av antioksydant Absorption of antioxidant
En 1,1 vektprosentig løsning av 1,3,5-trimetyl-2,4,6-tri-(3,4-di-tert-butyl-4-hydroksybenzyl)-benzen i etylacetat ble anbrakt i en kolbe. Nylig ekstraherte blærer ble anbrakt i løsningen og holdt der ved omgivelsestemperatur i 4 timer. Tidligere forsøk hadde vist at forholdet mellom vekt-prosentinnholdet av denne antioksydant som ble absorbert i blærene var lineær med 0,45% absorbert ved 1% konsentrasjon og 0,68% absorbert ved 1,5% konsentrasjon (4 timers absorpsjons-tid). Følgelig ble ca. 0,5 deler antioksydant pr. 100 deler polyisopren absorbert i blærene. A 1.1% by weight solution of 1,3,5-trimethyl-2,4,6-tri-(3,4-di-tert-butyl-4-hydroxybenzyl)benzene in ethyl acetate was placed in a flask. Freshly extracted bladders were placed in the solution and kept there at ambient temperature for 4 hours. Previous experiments had shown that the relationship between the weight-percent content of this antioxidant absorbed in the bladders was linear with 0.45% absorbed at 1% concentration and 0.68% absorbed at 1.5% concentration (4 hour absorption time). Consequently, approx. 0.5 parts antioxidant per 100 parts polyisoprene absorbed in the bladders.
Halveringstid- tes ter Half-life tests
Halveringstid-tester ble utført på blærer fremstilt slik som beskrevet ovenfor med unntakelse av at 1,2 deler tetrakis-[metylen-3- ( 3 ' , 5 ' -di-tert-butyl-4 1 -hydroksyf enyl) -propionat"] - metan pr. 100 deler polyisopren ble absorbert i blærene fra en aceton/toluenløsning istedenfor den ovenfor beskrevne antioksydant. Et antall av 24 av disse blærer fylt med 60 ml vann og holdt i luft ved 40°C hadde en halveringstid på ca. 14 måneder. Tilsvarende tester med syntetiske polyisoprenblærer fremstilt på stort sett samme måte, men uten silisiumdioksyd eller antioksydant indikerer at slike blærer har en halveringstid på fra 1 til 2 dager. Half-life tests were performed on blisters prepared as described above except that 1.2 parts of tetrakis-[methylene-3-(3',5'-di-tert-butyl-4 1-hydroxyphenyl)-propionate"] - methane per 100 parts of polyisoprene was absorbed in the bladders from an acetone/toluene solution instead of the antioxidant described above. A number of 24 of these bladders filled with 60 ml of water and kept in air at 40°C had a half-life of about 14 months Corresponding tests with synthetic polyisoprene bladders produced in much the same way, but without silicon dioxide or antioxidant, indicate that such bladders have a half-life of from 1 to 2 days.
Claims (15)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US23732581A | 1981-02-23 | 1981-02-23 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| NO820536L NO820536L (en) | 1982-08-24 |
| NO154181B true NO154181B (en) | 1986-04-28 |
| NO154181C NO154181C (en) | 1986-08-06 |
Family
ID=22893262
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| NO820536A NO154181C (en) | 1981-02-23 | 1982-02-22 | BLADES OF ELASTOMER MATERIAL FOR USE IN A MEDICAL INFUSION DEVICE, AND PROCEDURES FOR PRODUCING THEREOF. |
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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