CA1189027A - Bag for the storage of liquids - Google Patents
Bag for the storage of liquidsInfo
- Publication number
- CA1189027A CA1189027A CA000419050A CA419050A CA1189027A CA 1189027 A CA1189027 A CA 1189027A CA 000419050 A CA000419050 A CA 000419050A CA 419050 A CA419050 A CA 419050A CA 1189027 A CA1189027 A CA 1189027A
- Authority
- CA
- Canada
- Prior art keywords
- bag
- hose
- polyethylene
- film
- weight
- 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
Links
Classifications
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
- B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/30—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers
- B32B27/306—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers comprising vinyl acetate or vinyl alcohol (co)polymers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
- B32B7/04—Interconnection of layers
- B32B7/12—Interconnection of layers using interposed adhesives or interposed materials with bonding properties
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2323/00—Polyalkenes
- B32B2323/04—Polyethylene
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2439/00—Containers; Receptacles
- B32B2439/80—Medical packaging
Abstract
Abstract.
A bag for storing liquids for medical purposes such as blood and liquids for parenteral administration and which has neutral physiological properties is made of polyolefin material that is more specially in the form of a polyethylene film for the body of the bag and a copolymer of ethylene and vinyl acetate, with more specially 20 to 32 % by weight of vinyl acetate, as a material for the hose connector. The copolymer is welded to the material of the body of the bag and then cross linked.
A bag for storing liquids for medical purposes such as blood and liquids for parenteral administration and which has neutral physiological properties is made of polyolefin material that is more specially in the form of a polyethylene film for the body of the bag and a copolymer of ethylene and vinyl acetate, with more specially 20 to 32 % by weight of vinyl acetate, as a material for the hose connector. The copolymer is welded to the material of the body of the bag and then cross linked.
Description
1 PAG~ l I~ , BACK~ROUND OF T1-IE I~VENTIO~
e present invention is with respect to stora~e bags and ~cre specially to such bays for Me~ical purposes for the storin~ of blood or infusion solutions llnd made up of a thermoplastic polymeric material with at least one hose-like !outlet.
r Bags of this sort are used on a very large scale Eor met3ical purposes so ¦ hat the overall number of bags used is of the order of millions. Ti1e ba~s are jheeded for example for taking up blood as a blood storacJe bacJ or for the sterile llstoracJe of solutions for parenteral injection solutions. For this purpose the ¦pacJs have to be comE)letely sterile and to this end normally have to ~ he(l~ed to~
at least l~ decJreei C or more ~pecially abollt 12~ dec]rees C. ~ven ~or t~is rpose the therrnoplastic polymeric material has to have such properties that it ~,is thermally stable, at least up to the temperature to which it is heated for llsterilization.
~I Further properties desired of such bags are that they be light in ~eight, low in price and able to be produced automatically, while furthermore lltheir value after use is to be so low that they may ;n good conscience be thrown ¦jaway. Moreover the material o~ the bacJ is to be flexible, able to be folded ancl, ~lin the processed condition so glass-clear that it is possible to see at once if ¦Ithere have been any undesired changes in the liquid stored in the bag.
¦l The only polymer that so far has kept to this specification of desired properties is flexible vinyl, that is to say plasticized polyvinyl chloride ,(PVC) or polyvinyl chloride with the addition of plasticizers in order to c~et 1~tter elastic properties. Such plasticizers or softeners,, as for example 1 ~iisooctyl phthalate are however the cause of some undesired effects. In point ~f fact such plasticizers are not completely locked in the spaces between the polymer chains and may be leached out by the water or aqueous so~ution ~rom the polymer so that there is a contamination of the liquid stored in the bag.
Il ~
I ~GE 2 ,, It has been roughly worked out that a patient treated for solne time with solutions Erom such bags made of flexible vinyl will take up one graln of ~plasticizer in his body, that is likely to be the cause of long tenn llphysiological damage to the patient.
1 Moreover, if made of flexible vinyl, a bag is likely to be attacked by rnicroorganisms, that more specially will be responsible for leaching of the plasticizer and for this reason general destruction of the bag. In this res~ect such a bag of flexible vinyl after filling has to be safeguarded by a special 1outer E~ackaging structure to keep out SUCh microorganism.
I These facts in connection with such flexible vinyl ba(Js have made it irnpossible for theln to take the place of glass bottles, as have been norlnally sec1 to date, on any wide scale. In Eact, in some industrialized countries IPJ~ C authorities have not allowec1 tile use of vinyl bar1s for m~1ical ~urpose!;
at all.
l~ For this reason tests were undertaken on other materials with a view to coming across one that might be used in place of flexible vinyl, but all the naterials tested were overhigh in price or did not have the desired mechanical ~nd physiological properties. For example one tested rnaterial had an overly l high permeability to water vapor so that, if used, there would have t>een an ~ndesired increase in the concentration of materials in a solution storec~
tllerein. Furthe~r un(3esired pro~erties of the materials were the presence thcrei of substances that were readily leached out, or dalnat3e on rough handlint3 o~ the t3S. Il ll The Swiss patent ~4~,382 has an account of such a plastic bag, that may ¦
¦he used for therapeutic liquids for parenteral administration. l`he wall of this ¦~lastic bag is made of a resin laminate, that on the outer side, that is to say ~the side facing away from the liquid, has a flexible vinyl layer and on the ~nner side has a polyhalo~en hydrocarbon synthetic resin layer. This last-named j l~ayer is free of any substances that are undesired Erom the pharmacolot3ical l~oint of view and that might be leached out into the solution stored in the baq.
11~owever such polyhalogen hydrocarbolls as used do have the undesired property oE
.
Il I
e present invention is with respect to stora~e bags and ~cre specially to such bays for Me~ical purposes for the storin~ of blood or infusion solutions llnd made up of a thermoplastic polymeric material with at least one hose-like !outlet.
r Bags of this sort are used on a very large scale Eor met3ical purposes so ¦ hat the overall number of bags used is of the order of millions. Ti1e ba~s are jheeded for example for taking up blood as a blood storacJe bacJ or for the sterile llstoracJe of solutions for parenteral injection solutions. For this purpose the ¦pacJs have to be comE)letely sterile and to this end normally have to ~ he(l~ed to~
at least l~ decJreei C or more ~pecially abollt 12~ dec]rees C. ~ven ~or t~is rpose the therrnoplastic polymeric material has to have such properties that it ~,is thermally stable, at least up to the temperature to which it is heated for llsterilization.
~I Further properties desired of such bags are that they be light in ~eight, low in price and able to be produced automatically, while furthermore lltheir value after use is to be so low that they may ;n good conscience be thrown ¦jaway. Moreover the material o~ the bacJ is to be flexible, able to be folded ancl, ~lin the processed condition so glass-clear that it is possible to see at once if ¦Ithere have been any undesired changes in the liquid stored in the bag.
¦l The only polymer that so far has kept to this specification of desired properties is flexible vinyl, that is to say plasticized polyvinyl chloride ,(PVC) or polyvinyl chloride with the addition of plasticizers in order to c~et 1~tter elastic properties. Such plasticizers or softeners,, as for example 1 ~iisooctyl phthalate are however the cause of some undesired effects. In point ~f fact such plasticizers are not completely locked in the spaces between the polymer chains and may be leached out by the water or aqueous so~ution ~rom the polymer so that there is a contamination of the liquid stored in the bag.
Il ~
I ~GE 2 ,, It has been roughly worked out that a patient treated for solne time with solutions Erom such bags made of flexible vinyl will take up one graln of ~plasticizer in his body, that is likely to be the cause of long tenn llphysiological damage to the patient.
1 Moreover, if made of flexible vinyl, a bag is likely to be attacked by rnicroorganisms, that more specially will be responsible for leaching of the plasticizer and for this reason general destruction of the bag. In this res~ect such a bag of flexible vinyl after filling has to be safeguarded by a special 1outer E~ackaging structure to keep out SUCh microorganism.
I These facts in connection with such flexible vinyl ba(Js have made it irnpossible for theln to take the place of glass bottles, as have been norlnally sec1 to date, on any wide scale. In Eact, in some industrialized countries IPJ~ C authorities have not allowec1 tile use of vinyl bar1s for m~1ical ~urpose!;
at all.
l~ For this reason tests were undertaken on other materials with a view to coming across one that might be used in place of flexible vinyl, but all the naterials tested were overhigh in price or did not have the desired mechanical ~nd physiological properties. For example one tested rnaterial had an overly l high permeability to water vapor so that, if used, there would have t>een an ~ndesired increase in the concentration of materials in a solution storec~
tllerein. Furthe~r un(3esired pro~erties of the materials were the presence thcrei of substances that were readily leached out, or dalnat3e on rough handlint3 o~ the t3S. Il ll The Swiss patent ~4~,382 has an account of such a plastic bag, that may ¦
¦he used for therapeutic liquids for parenteral administration. l`he wall of this ¦~lastic bag is made of a resin laminate, that on the outer side, that is to say ~the side facing away from the liquid, has a flexible vinyl layer and on the ~nner side has a polyhalo~en hydrocarbon synthetic resin layer. This last-named j l~ayer is free of any substances that are undesired Erom the pharmacolot3ical l~oint of view and that might be leached out into the solution stored in the baq.
11~owever such polyhalogen hydrocarbolls as used do have the undesired property oE
.
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2'7 1l ,! L'~ 3l I' i being t~igh in price with respect to manu~acturing and processing ancl furthermore of not ~using to the desired degree on rnaking welded seams so that there is in fact still direct contact with the flexible vinyl. Sucll undesired direct contact llis furthermore to be seen at the outlet opening structure that is normally rnade co~pletely of flexible vinyl and may be joined up with further connection hose of flexible vinyl. ~loreover such a throw-a-~ay or disposable ba~ has undesired effects on the environment inasfar as when the bat3 material is burned tly(lroge halides, that are strong chemicals, are let off into the atmospllere.
1 A further bag is to be seen in the U.S. patent ~,140,162 wtlich is made 1~ up of a resin com~osition with three components. These com~onents are a polyolefin, that is by and large rnade up of propylene unit only, a block copol~ner anc] if needed a plasticizer, that may as well be a pol~ner.
further components o~ the ba~3 arltioxiclants In~y be used, that may har lly be Ittlougtlt o~ as tly~ienic arld healthy ad-litions.
15 ll It will be clear from the observations made herein so far on t~ossible Il l Ipomponents that not only the components as such but furthennore the procesSin~
¦Ithereof are high in price and that a bag or recipient made of such mater;als is ¦~lardly likely to be in the position of takinc~ the place of normal flexible vinyl Ibags, this being for reasons of price and of process engineerin~
1 It is for this reason that the present assi~nee herein has ma~le a ~ermcm ~atent application (see German O~fenl~gunc~sschrift speciEication 3,~26,974) cov~rinc3 a further plastic or resin composition Eor proclllcin-J conllection elements for joining vinyl hose to polyolefin ~-3s. This plastic cor~position is ¦
l~gain made up of a number of polymeric components, that from the point of viewl bf manufacturing technolo(3y and price are not any better than the components ¦
~taken into account so far. ~urthermore this connection element has to be able to be welded not only to the polyole~in bag but furthermore to the flexible inyl hose, an operation tllat would no mally be higt) in price and not rea-~ily ILndertaken.
ll rrhe special point to be kept in mind in connection with the suJIestior)s lf the prior art is that in every case a flexible vinyl connectioll hose is used, ;
I !
,1 1 7 r that by its very nature tlas a plasticizer an~ is a dan~er to health.
Such connection hose, that is normally welded to the ~lexible vinyl baJs as an o~ltlet nipple or spout, has the desired higl~ly elastic properties necessary if the plu~J-on end connectors are to be kept in place and there is tobe no chance of the li~uid stored in the bag runninJ Ollt between the stopper and nil~ple on sterilization at about 12~ degrees C. ~ further point is thdt the stopper has to be so firmly gripped in the piece of hose round it that it may only be pullecl out of it USitlC~ a strong I~ullin~3 force.
~ Another point to be kept in mind is that in the food L~roducts industry flexible plastic ha~s have lon~ heen in use, which in some cases have had a welded on outlet sEx~ut made of the same material as the rest of the ba~. Such outlet structures do however not have the highly elastic properties as noted ereinbefore and for this reason rnay only be sterilized if the bag as sucl-l is able to be sterilized.
CLNEI~t WlLTNE 0~ INV~NI[0~
It ~lll be seerl Erom these observations that one ~)url)ose or ob~ecl: o( the present invention is that ot designin~ a hag of the sort noted, that may be sterilized by heat at a temperature of at least 1~ degrees C and has at ]eAst lone hiyhly elastic outlet nipple or spout.
A further object or purE~ose of the invention is that Ot designin~J a ba~
of the sort noted hereinbefore that may be manufacture~ from a colrunonly user],¦llow price plastic or resin material, that aEter the manufacture of tl~e ~3~J will
1 A further bag is to be seen in the U.S. patent ~,140,162 wtlich is made 1~ up of a resin com~osition with three components. These com~onents are a polyolefin, that is by and large rnade up of propylene unit only, a block copol~ner anc] if needed a plasticizer, that may as well be a pol~ner.
further components o~ the ba~3 arltioxiclants In~y be used, that may har lly be Ittlougtlt o~ as tly~ienic arld healthy ad-litions.
15 ll It will be clear from the observations made herein so far on t~ossible Il l Ipomponents that not only the components as such but furthennore the procesSin~
¦Ithereof are high in price and that a bag or recipient made of such mater;als is ¦~lardly likely to be in the position of takinc~ the place of normal flexible vinyl Ibags, this being for reasons of price and of process engineerin~
1 It is for this reason that the present assi~nee herein has ma~le a ~ermcm ~atent application (see German O~fenl~gunc~sschrift speciEication 3,~26,974) cov~rinc3 a further plastic or resin composition Eor proclllcin-J conllection elements for joining vinyl hose to polyolefin ~-3s. This plastic cor~position is ¦
l~gain made up of a number of polymeric components, that from the point of viewl bf manufacturing technolo(3y and price are not any better than the components ¦
~taken into account so far. ~urthermore this connection element has to be able to be welded not only to the polyole~in bag but furthermore to the flexible inyl hose, an operation tllat would no mally be higt) in price and not rea-~ily ILndertaken.
ll rrhe special point to be kept in mind in connection with the suJIestior)s lf the prior art is that in every case a flexible vinyl connectioll hose is used, ;
I !
,1 1 7 r that by its very nature tlas a plasticizer an~ is a dan~er to health.
Such connection hose, that is normally welded to the ~lexible vinyl baJs as an o~ltlet nipple or spout, has the desired higl~ly elastic properties necessary if the plu~J-on end connectors are to be kept in place and there is tobe no chance of the li~uid stored in the bag runninJ Ollt between the stopper and nil~ple on sterilization at about 12~ degrees C. ~ further point is thdt the stopper has to be so firmly gripped in the piece of hose round it that it may only be pullecl out of it USitlC~ a strong I~ullin~3 force.
~ Another point to be kept in mind is that in the food L~roducts industry flexible plastic ha~s have lon~ heen in use, which in some cases have had a welded on outlet sEx~ut made of the same material as the rest of the ba~. Such outlet structures do however not have the highly elastic properties as noted ereinbefore and for this reason rnay only be sterilized if the bag as sucl-l is able to be sterilized.
CLNEI~t WlLTNE 0~ INV~NI[0~
It ~lll be seerl Erom these observations that one ~)url)ose or ob~ecl: o( the present invention is that ot designin~ a hag of the sort noted, that may be sterilized by heat at a temperature of at least 1~ degrees C and has at ]eAst lone hiyhly elastic outlet nipple or spout.
A further object or purE~ose of the invention is that Ot designin~J a ba~
of the sort noted hereinbefore that may be manufacture~ from a colrunonly user],¦llow price plastic or resin material, that aEter the manufacture of tl~e ~3~J will
3~ in a sterile condition .3nd may be straightway Eilled with a sterile li~luid.Il For eEÇectin~ these and further purposes or o~)jects of th~ invention the ~bag is made of a polyolefin, that has at least one outlet structure made oE
Icross-linked corJolymer of an olefin and a vinyl acetate.
I~ The bag produced using the teachings of the invention may be made up of p~astic or resin materials that are very low in price, as for exampleIpolyethylene. The Eilm nee~ed for manufacturing the bag may be prodllced tyl Inormal processes for making film or blown film, and which for those in the art lare generally speakin3 simple and trouble-free.
'; I
, I I
Furthermore the hose, tllat is used for producing the pipe-like outlet¦
~structure, is made from very low-cost olefin starting materials, that are ~opolymerized with a certain level of vinyl acetate (VAC).
I~ On an increase in the level of VAC it is possible to get a sharp lincrease in the rebound resillence, that is a measure for the elasticity of the ~hose. ~!ose structures made of yolyolefin only are less good than this copolymer inasfar as they are not elastic enough and may not be ~oined up with different forms of connectors, such as a coupling and the like so as ~o give a join with a ~ fluid-tight seal or seating effect so that they do not keep to a very important ~IFondition in connection with medical apparatus. For this reason so far flexible ~inyl hose, that has these very good elasticity properties as noted, and 110 ~ther material, has had to be used.
If ~or example a copoly~ner of ethylene and vinyl acetate ~EV~) i5 used, lit will be seen that althougt) on increaSing the level of V~C the rel~o~
resilience is stepped up, there is a decrease io tlle melting point in the VAC
¦range of interest to under 100 degrees C. so that, if made with such hose ~onnection piece, such a bag would no longer be able to be sterilized.
Although it is kno~m that hose based on VAC containing polyolefins may ~ stabilized thermally by cross linking and that it is even possible for their !~lastic properties to be stepped up, those in the art are conscious of the fact ~that such cross linked hose structures are not able to be welded to the base or ¦~tarting polyole~in (of which the bags are made) by itself and that in fact no onnection or weldment is produced between the polyolefin and the cross linked ~opolymer that is made up of olefin and VAC.
j The surprising discovery has now been made ~ithin the framework of the ~resent invention that a polyolefin bag and a hose (that so far has not been ross linked) made of a copolymer of olefin, ~ore specially ethylene, and VAC
~ay be welded together. After the cross linking of the copolymer the weld or l ~oin is still in existence, that is to say it is not damaged by the cross linking and what is more is that the end product still has the properties thatl~e starting material had in the first place.
Il I
Il I
¦I PAGE
A fact that i5 to be more specially noted is that such cross linked ~iece of hose, that is welded into a polyethylene bag as an outlet nipple, hasthe good elasticity and thermal properties, which make it possible for a bag ofllthe present invention to be sterilized at high temperatures, as for example at ¦about 12a degrees C, and make quite certain that the hose connector piece makes ¦~a strong join so that coupling pieces fixed thereto may not be pulled off it.
It is seen rom this that such a sterilizable bag for medical purposes hasl mechanical properties that are at least equal to those of a nonnal flexible i vinyl or PVC bag. I
¦ A further point is that the new bag is free of plasticizer, because the j polyolefin materials normally used as a film material are made without the ¦
addition of any plasticizers. For this reason there is no chance of attack by microor~Janislns and in tllis connection ~he bag of the invention wilL be seen to ~t~ more hygienic in every possible respect than flexible vlnyl ~1-3s as currelltly ~in use.
Polyolefins that may be used as polymers for producing the bag of the present invention May for example be polymers produced from ethylene, propylene,Ibutylene and the like. T~le preferred olefin used as a starting material is ¦
,ethylene, that may be substituted with one or more groups.
I Possible substitutients in this respect are for example the methyl or~
~the ethyl group, the vinyl group and halogen atoms, more specially fluorine atoms .
Ethylene that has been polymerized to polyethylene is more specially preferred.
More specially used examples of polyolefins are polyethylene,polypropylene, poly-n-butylene, polyisobutylene,~l poly-4-methylpentene-1, chlorosulfonated polyethylene, polystyrene, halogenated ¦
Ipolyethylenes such as polyvinyl fluoride, polyvinylidene fluoride, and¦
¦polyvinylidene chloride, polymethyl metacrylate and the like. The olefins used jusecl for producing these polyolefins may furthermore by used in the form of Fopolymers with other vinyl compoullds, as Eor e~ample ethylene/propylene lastics, poly(ethylenevirlyl acetate), acrylonitrile/butadiene/styrene pol~ners, ethylene-propylene block pol~ner, styrene copolymers, copolymer containing ~inylidene fluoride, and copol~ners containing styrene.
Il Polyolefins are products of ~e present invention, that have been l~produced by the vinyl polymerization of ethylene that may be substituted if ¦desired. These products may furthermore have additions of small amounts of ¦Ifurther polymers, that are not, by and large, responsible for any undesired lleffects on, or any changes in the structure of these polyolefins. It is as an ¦lexample to have small additions of ethylene compounds substituted with styrene lor polyacrylonitrile The polyolefin products so produced are looked upon as ¦coming within the same ~roup as the polyolefins noted hereinbefore.
In the invent;on the preferred polyolefin used Eor the bac~s is oly~thylene, that may if ~Qsired have the additions of ~,mall amounts o vlnyl ~cetate in the onn of ethylene vinyl acetate copolymer. In such a case the ~evel of the vinyl acetate may be up to 10~ by weight.
More specially a medium to high density polyethylene (ML~ and ~A) is ~sed that normally will have been produced by low pressure polymerization. In ¦this respect the density will be in a range of 0.91 to 0.94 and more specially ~ill have a value of 0.935 g/cc.
I Furthennore the form of polyethylene that is more specially used in the invention has a high molecular wei~ht and a narrow molecular weic~llt distribution range.
In every case however care is to be taken to see that such polyolefins ~o not have a rnelting point under the sterilizing temperature of 110 to 120 ¦degrees C. More specially the melting range is to be over 116 de~rees C and ~ore limitedly is to be at 12~ to 124 de~rees C, while the Vicat softening ~emperature (DIN 53,460) is to be greater than llS degrees C.
In the case of the EVA polymer noted hereinbefore (copolymer oE ethylene l~nd vinyl acetate) there is a decrease in the melting point for every increase lin the vinyl acetate level so that such products have to undergo a cross linking -rocess, as will oe detailed hereinafter, tefore any sterilization op*rstion.
P~.GE 8 ~I The permeability of the polyolef;ns noted to water vapor and oxygen may ¦ be responsible Eor trouble conditions when solvents are stored Eor a long timeso that there may be an ;ncrease in the strength of the solution and oxygen may ~nake its way into the solution from outside and the dissolved components may be5loxidized, something that is more specially undesired in the case of amino acidsolutions so that steps have to be taken for putting an end to any such transferof oxygen.
For stopping any such transfer, a useful sealing effect may be produce:
l ~y coating the said polyolefin film of the bag on its outer face with one o:
10nore layers for lowering the permeability for water vapor and oxygen, the ~oating material beinq or example a metal ~ilm or another polymer. Such an ~uter layer or coating may furthermore be usefully used as a cJener~L saeaty ~neasure, inasfar as even i~ ~hey are very carefully pra~ucecl the~ bag ~ilms may jstill have pin holes, that are hard to see and may have an undesired effect on 15~the sterility of the solution put in the bag.
A further point is that such an outer coating may make the bag very much ~tronger physically so that it may be dropped from a height of some meters ~ithout bursting.
Usefully the film or Eoil used is of such a nature that it has a higher 2(~nelting point than the polymer next to the solution. Putting it cliEferently uch outer layer is not to be melted at the melting point o tl-e inner ancl there s for this reason no chance of its sticking to the welding or hot sealing tool.
rn this respect such an outer foil or film may be thought of as a pcarting film l ~n welcdin~ the inner film.
25'~ As a polymer for making such a laminated structure any of the polyolefins named hereinbefore may be used. ~lowever the preferred polymers are hose that have a low permeability to water vapor and a low permeability to ~xygen. Polymers coming ~1ithin such a group are for example polyamides, PVC, ~olyvinylidene chloride, polyvinyl fluoride, polytrifluorochloroethylene, 30~olyethylene terephthalate, polyesters and the like. Those which are more ~pecially preferred are polyamides, polyvinylidene chloride, polyethylene 2~
g terephthalat and polyesters.
A more specially used polyamide may be a polycaprolactam -tha-t may be processed and s-terilized using superheated steam at a -temperature of 120 to 140 degrees C. Q
useful effect is to be produced if this polyamide is free of stabilizing addi-tions and in this respect has a composition meeting the needs and conditions of food products industry.
The polymeric outer and inner films are best united using a laminating adhesive, such as polyvinylidene chloride or polyurethane. Such a polyurethane adhesive may usefully be a two componen-t adhesive, the first componen-t being a laminating adhesive and the second component being an additive lacquer.
From the point of view of process engineering the polyolefin used as the inner film be may produced as blown film and then bonded to the coating film using one of the said laminatlng adhesives, in which respect polyurethane is preferrecl for this pu.rpose.
lf the outer fllm ls :in the fo:rrn oF PVC the~
polyolefin F`ilm used :in the inverltion will make ce:rtain that there is no chance of the plasticizer present in the PVC
diFfusing through the laminating adhesive and the polyolefin film into the solution being stored in -the bag.
At 85% relative humidity and a temperature of 23 degrees C preferred laminates have a permeabili-ty to water vapor (as measured using the test noted in DIN 53,122) of less than 1. Such values are kept to by standard shee-ting with a thickness of 50 to 100 and more specially 75 microns in the case of polyolefin filrn and 20 to 100 or more specially 30 to 70 microns in the case of polymeric lamlnating fllm, such as a polyamide.
Furthermore in the case of such a preFerred laminate the permeability to oxygen is decreased and may be under a figure of 15 cc/sq m times the number of days times the pressure difference in bar.
Such films are for example marketed by Sengewald, Halle, Westfalen, under the name "Flexovac V 7l44"* and -from -the physiological point of view have been given approval by the West German Ministry of Health in Berlin and moreover by -the FDA in the United States for use in connection with food products and in * Trade Mark %~
eclicine As has been noted earlier, the polyolefin film next to the l;quid bottled in the bag is free of plasticizer and of any other addition that might~
~llbe a danger to health and more specially miyht make its way by diffusion into ¦
l¦the aqueous solution~ Furthermore the polyolefin ~ilm, that may if needed be ¦Icovered over with an organic laminatin~ film, is glass-clear and transparent and j ill have such properties after sterilization~ ~
AS a material of the outlet structure or nipple an olefin-vinyl acetate ¦
Icopolymer may be used. As polyolefins that may be produced from this olefin, it ¦
¦is possible to make use of the olefins named hereinbefore in connection with producing the ba~3. Such olefins have a level of vinyl acetate in the copol~ner I
of 5 to 4~ and more specially 8 to 35 or ev~n more limiteclly o~ 2~1 to 3~ '~ I)y¦
~eigtlt. ~s made cle~r earli~r, the melting ~oint of polyethylene c~oes dowl~ wl~h bn increase in the vinyl acetate level from about 125 degrees C to about 7 ~egrees C at a VAC level of 30g by weight. It goes without saying that at a sterilization temperature yreater than 1~0 degrees C such a hose will be melted ~nd for this reason would be useless. On the other hand the rebound elasticity ¦of such hose material desired goes up with an increase in the VAC level from 35¦to 55% in the case of a 30% VAC level.
j Moreover such a hose-like material containincJ V~C may be very readily ~elded to the material of the bag, if the polyolefin material used there~or is ~enerally or completely the same. The use of polyolefin materials that are l ~enerally the same for the connector piece and the bag is for this reason ¦Ipreferred~ More specially the material used for the outlet structure is ~opolymer of ethylene and vinyl acetate (EVA) with the weiyht ranges as noted hereinbefore, in which respect the bag material may well be polymerized ethyle~ne ~r propylene cornpounds. A preferred combination is one of EVA as the rnaterial 1jfor the outlet structure and polyethylene as the bag material with the weight jranges given hereinbefore.
EV~ is for example put on the market by I~OECHST A~l under the trade narne ~f "Hostalen LD/EVA" and by ICI under the trade name of "Evatane" ancl "Alkathene PAGE lll Il l EVAi.
~rhe production and processing of the materials or the bag may be' undertaken in a way generally used in the plas~ics art. For example, as madel llclear earlier, the bags may be produced from blown film, that is cut to size and then welded at the edges. Such a bag, that is not welded together at its edges ~ere the connection opening is to be placed, is then welded to a piece oE hose ¦lof a male part having the outlet opening or opening therein, such male partl ¦~being placed on a mandrel into the opened up ba~. Nextly the full edge which;
¦¦has so far not been welded is heat sealed to the inner hose piece or ~ale ¦connection piece. If there is more than one hose connection piece, such welding1 and connection operations are naturally undertalcen at the same time using j customized welding tools. I
11erein the wordlng "hose connection piece" is uscd in thc sense o~ a1 Ipiece o~ hose prodl1ci1lg the liquid connection between the space ~ithin t!~e ~kll:J~
and infusion apparatus, catheter, Lnjection syringe or the like that is joined 1up with the hose connection piece. The said wording is used herein as l~furthermore covering an inner part, that is welded in position within the bag 1 ¦¦and has at least one outlet opening without, however, such inner part having thel ¦¦form of a piece of hose running out from the edge of the said bag. Such an1 11inner part is slipped, li1ce a piece of hose, into the edge part of the hag where ¦
¦1the edges have 50 far not been welded together and then thermally united and ~welded to the bag.
¦~ The bags produced on these lines have generally the same properties as a ¦¦flexible vinyl or PVC bag with the di~ference however that the connection hose~nade of EVA would be ~elted on sterilization at over abou~ 80 degrees C so that~
thermal sterili~ation of such a bag would not be possible. On the other hand the weldment, that is fonned between the bag and the hose connection piece, is so stron~ that the piece oE hose would only be able to he taken out by force.
~ In order to ~ake it possible for the hose connection piece to be able to ~ sterilized, it has to be cross linked so that the ~ne:Lting point oE the hose and its elasticity are greatly increased. ~y way oE such cross linking ll Il ~
llprocessing it in fact becomes possible for the finished bag to be sterilized atl ~Itemperatures of up to about 12~ degrees C and thereover. Furthermore the cross I linlced hose has very much better elastic properties than a flexible vinyl hose,~
that normally has to be heated up before it rnay be slipped onto certain llconnection elements.
I A further discovery made in development of the present invention is the ¦fact that such cross linking is not responsible for unjoining the material where lit was welded, as might have seemed likely in the first place inasfar as cross ¦linked EVA may not be welded to polyolefin material, such as polyethylene, by 1 ¦¦itselfO
The cross linking operation may be undertalcen in a known way of cross ¦linking EV~. It may take place for ex;~mple by u5in~3 h1~3h energy radiation, a5 Eor ~xample usin-~ accelerated electrons alpha and gamma rays witt~ an enerJy o over 2.5 Mrad. More specially the operation will be undertaken usin~ a level o~
to 10 Mrad, the exact figure being dependent on the nature and thickness of the material to be cross linked.
The useful effect of such process step is that the bag, that has been ~
sealed and is generally free of pyrogens, is sterilized by the hi~h energy ¦
l irradiation so that a solution that has been sterilized beforehand may be filled llinto the bag, that is to say it is not necessary to undertake tllermal processing ~in an autoclave. A still further useful effect of the proces5ing by the use of radiation is that iE the polyethylene has not been completely polymeri2ed, or i~
the film of ~lich the bag is made has a small amount of EV~ therein, such ~naterial may be cross linked and be given better mechanical properties so that ~terilization temperatures as high as 130 degrees C may be used.
¦ A further possible way of causing cross linking is one using peroxides, ¦~s for example cumol peroxide or the like, that are decomposed by heating so llthat radicalic cross linking is started therebyO In this it is naturally ¦~ecessary for the production of the EVA hose, that is normally undertaken while Iheated, to be combined with the production of the bag, seeing that otherwise the ~ msterials would e cross linked and would then no longer be sble to be welded to the polye-thylene used as the ma-terial of the bag.
A further way of cross linking -that is as well based on the addition and decomposition of chemical compounds makes use oF silico-organic compounds, that are decomposed in a humid warm atmosphere and then have the effect o-F cross linking the EVA with the formation of silicon bridges. One example For -this Si cross linking process is the ~Sioplas process"* o-F ICI, in which the silico-organic compound is mixed into -the EVA
granules and the product is extruded as -the desired film or hose. In this case as well the cross linking takes some hours to some days dependent on the degree of humidi-ty used and the -tempera-ture. In Fact the cross linking operation may be undertaken in about one hour using a temperature of ove:r 8û
degrees C and a relative humidity of 10055.
This process as well naturally makes it necessary For the Film and the hose to be produced together and at the ba~ of the :invent:ion.
Of the poss:ible processes i'or undertak.ing cros~
linking, the method us.ing high energy radiation and process.incJ
using silico-organic cross linking compounds are preFerred.
A further fact to be specially noted is tha-t any sort of cross linking process may be used if it is such that the polyolefin hose (that is not so far cross linked and has been welded to the bag ma-terial) having a certain level oF VAC
may be cross linked.
Further cletails of the invention will be seen from the account now to be given using the -figures.
LIST OF Ti-lE DIFFERENT VIEWS OF T~IE F:CGUF~ES.
Figure 1 is a diagrammatic view of a bag f`or inf`usion purposes, as seen looking down onto the bag.
Figure 2 is a section taken on the line II - II of the figure 1.
Figure 3 is a view of the opening oF a hose-like connection head made of EVA.
Figure l~ is view looking down on-to part of a further * Trade Mark 2~7 ! PAGE 1 working exalnple of the invention in the form of a male part without a frangible cover.
¦l~igure 5 is a section taken on ~he line V - V of th~
¦¦ figure ~A
l~igure 6 is a view looking do~n on a further example, that is jl somewhat like the example of figure A.
¦~iyure 7 is view of part of a working example oE the invention as seen frGm the side, to make clear the design of the casing of a hose connection head.
l DETAILED ACCOUNT OF l~ORKIN~ EXAMPLES OF INVENrION.
Turning to the figures and more specially to figure 1, it will be seen that a bag 10 is in the form of a wall structure with an inner sl~ce 12, that l~ a welded edge 1~ running rigtlt tlle way rowld it. 'l~le ha~ 1~ has. two ollt:Lqt ¦~p~nings 16 and l8, that in each case are fitted with a hose connector or Ibonnection head numbered 20 in the one and 22 in the other case, such connectors ~orming spouts or nipples. It is by way of these connectors that the liquid to ~e stored, as for example an infusion solution or blood, may be run into the inner space or chamber 12 of the ba~ l~. In this respect it is possible for ~nly one of the connectors or the t~o of them to be used Eor the inlet of the Liquid.
Such a bag has so far normally been manufactured by firstLy placin~ the wo cut 0l3t pieces of film together face to face and then welcling them together , ~long most of the edye l4 but not at the outlets 16 and 1~. Nextly the ~onnectors 20 and 22 are slipped into the outlets 16 and 18 using a mandrel (not ~igured) and they are then welded along their outer faces of the bag film. As ~oted earlier in this connection, the preferr~l material for the bag is ~lyethylene and the preferred material for the hose material is EV~. After ~ein~ welded together the EVA material is cross linlced, this being done more ~pecially with the help of ionizing radiation.
3~ I For infusion purposes the hose connector 20 is filled up with a hollow Itopprr 23 designed for such iniusion. ~lis stopper has a fran3ible sterile Il 2~ 1 ;diaphragrn 24 that is normally made of chlorobutyl rubber and may readily be¦
pierced by an injection needle. This diaphragm 24 is covered over with a guard Ithimble 25 for hygienic reasons after the diaphragm has been fixed on the ¦stopper 23 by some known method. ~e stop~er is nonnally Inade of ¦~lycarbonate. -The other hose connector 22 may be fitted with a syringe stopper 2~ or plug, that is best made of polycarbonate material as well and has an inner part 27~ made for example of latex, that is readily pierced by a hollow needle.
I, Once these stoppers 23 and 26 have been forced into the connectors 2X
land 22 made of cross linked E~ , that are widened out somewhat, they may only be ~lled out again by using a very strong force and they are in fact firmly seated ~d jarrmed in positionO
In view o the fact that the ~1~ is nonnally supported in use by han~Jin~
~t up with the hose connectors 20 an~ 22 pointin~3 c]ownwards so that the ~olutlon in the bag may be run out Erom it without any trouble, the edge 14 of the bag 10, that is opposite to the hose connectors 2~ and 22 has an eye 28 so that the op end of the bag 1~ may be hooked onto a support part such as a stand or the ~ike for keepinq the bag in the desired position where it is used.
Il As part of the preferred workiny example of the invention, that is to be ~een on a ~reater scale in figure 2, the rnaterial of the bag la is a laminate 30 ~hade up of Eilm layers sanclwiched together. In line with one rnore specially ~reEerred teaching of the present invention, this laminate has on its side next ~o the solution a layer of polyethylene film 34, that will nonllally have a ¦Lhickness of 30 to 100 microns and more specially 75 microns. The preferred ~lyethylene materialhas a density of 0.935 g/cc, a melting range of 121 to 124 ~egrees C and a Vicat softening temperature oE rou~hly 118 degrees C.
¦1 on this polyethylene film 32 a polyalnide film 3~ is bonded using a ¦~olyurthane adhesive, such film 34 having a thickness in the range of about 30 ~ 70 microns.
~ From figure 2 it will furthermore be clear that near the joins with the ose connectors 20 and 22 the polyethylene film 32 has a welded seam 36 Eonning Il %~
~la strong and homogeneous bond between the foil and the connectors 20 and 22 so ¦Ithat there is not the least danger of the connectors being pulled out of the bag 10 without serious damage to bag 1~ generally.
! A Eurther working example of the hose connectors 20 a~d 22 will be seen ¦lin figure 3 in ~hich only the end parts are viewed, that is to say without ¦Iseeing the weld part ormin~ a join with the bag rnaterial. me end part 38 of ¦the hose connectors 20 and 22 has, near the end 9~ that is pushed into the bag, ; diaphragm 42 running across the end 40 and shuttinc3 off the inside of the bag l~ompletely from the outside. This diaphragm 42 is pierced open, when the bag is ¦~sed, by the point of an infusion apparatus that is not figured, to let off ¦liquid from the bag 10. Because as noted the bag will normally be hanging ~ pside down when used, it is necessary to have a seal between the point ~x~rt o~
the lnfusion apparatus ancl the wall o~ the ho~e as otilerwise ther~ would b~ a langer oE the liquid rullnin-3 out freely. ~o this end the inner face ~ the hose ear the opening 40 has a ring-like bead ~4 designed to be pressed against the ~ int before piercing the diaphragm 42.
Such hose connectors 20 and 22 having a diaphragm 42 will be produced by known injection molding process before being welded to the bag 10. A mandrel, LPecially designed so that the diaphragm 42 will not be pierced thereby, is used Eor slipping the connectors 20 and 22 into the outlet openings 16 and 18.
¦ Because, after being sterilized in an autoclave, the cliaphragn~ 42 ls to Ipe kept in a sterile condition, the opening A~ is covered over with a skin ~6 ~hat may be peeled off when this is desired.
I Tha form of the invention to be seen in figure 3 naturally has to have a ~illing opening ~8 at the edge of the bag 1~, such opening being shaded in ~igure 1 and not being welded over when the rest of the edge of the ~ag is ~elded, as was the case with the outlet openings 16 and 18. ~e opening ~8 nakes it possible for the bag 10 to be filled and after filling has taken place s is shut by welding or hot sealed in a normal way.
¦1 A still further working example of the invention is to be seen in Eigures 4 and S that has a plug piece SE that ie generally made up oE tl-e plu3 body 52 that has two convex sides (fi~ure 9)~ Such a form makes it sirnpler for lithe welding to the inner film 32 to be undertaken at the edges to get a more or ¦less completely smooth join between the welded edge 14 and the inner pluq body ~52.
~ is plu~ body 52 as figured will be seen from figures 9 and 5 to have ~nlet and outlet openinqs 59 and 56~ Furthermore it has a filling opening 58 on ~hich some observations are to be made hereinafter.
The inlet and outlet openin~s 54 and 56 are each joinec1 up with a l~ose-like connector 6~ and 62 or headpiece. Such connectors may be of the same ¦besign as in the worlcing examples of the invention to be seen in figlJres l ancl i~. In Eact the connectors may again have diaphragms ~ and ring-~like beac1s 66, ~uch a system then makin~J the eilling opening 58 nece5sary, th~t may be safely ~toppercd with a plu~ of the rl~ht ~orm after filling h1s taken plelce~
¦ In the workin~ example oE the invention to be seen in fkJure 5 the ed~es ~f the connectors 60 and 62 are in each case joined up by way of lines of , ~eakness 68 with a tear-off cover 70, that on the one hand keeps the diaphragm sterile till the time of use and on the other hand is so designed that it may be readily torn off before such use.
¦~ It is naturally ~ossible for the example of the invention of Eigures ¦, ~nd 5 to be designed without diaphragms 54, the tear-ofE cover 7~ and the beac]s ;6, this Inaking t~le Eillinq opening ~mnecessary. It furthermore ~oes without ,aying that it is possible to have one or rnore connectors 6~ or 62.
¦ Figure ~ is a view of a further form of such an inner or male part 72 ~orming part of the present invention. It is generally in the form of a male ~ody 74 that is convex on its two opposite sides so that its fonn is by and Large the same as that of the male body 52. The thickness of these male bodies 2 and 7~ is such in this respect that thickness-wise they are lined up with the ~elded edge 14 so that tl1ere are no outwardly running parts of the bodies 52 and ~.
3 In the case of the inner or male body 7~ to be seen in figure 6 there ~re for this reason no hose-like connectors 60 and 62; that is to say the male PAGE l8 body 7q only has two inlet and outlet openings 76 and 78 running through it from~end to end. In these holes it i5 then possible Eor the stoppers 23 or 26 of figure l to be placed to give a Eurther useEul efEect~ On the other hand it is naturally possible for tl1e inlet and outlet openings 76 and 78 to be shut off in ~¦the same way as in the example of figure 3, that is to say using a diaphragm 80, that is best placed on the lower surface oE the male ~)dy 7~ In such a case there will again be a filling opening 82, tha~ is marked in broken lines in ~figure 6. This filling opening 82 may again be shut off using a stopper oE the ¦right size. The inlet and outlet openin(3s 7~ and 78 may, if a diaphragm ~'3a is ¦;used, be covered over with a piece of skin or diaphragm that may be peele~] oEf, ¦to keep the inlet and outlet openin~3s 7~ and 78 sterile, such skin being place~
¦~ver the male body 74.
Fi~ure 7 is a section view oE a Eurther working example of tl~e pr~'sent invQrltiol1 which is clesignlad or1 qenerally the same lines as the example oE E~-Jure ~ only a hose-like connector 8~ being seen here, that has been welded into the g 10 at the at the edge thereof l4.
¦ The section of figure 7 as part of the bag 10 is generally on the same ines as the part of the bag 10 to be seen in figure l, with the diEEerence ~however that at the connectors ~4 there are two folcl-like parts 86 placed on top of each other. When their edges have been weldecl together at 88, 9~ and 92 they are completely and liqu;d tig~tly placed round the connector ~ 1e last-named is in this form of the invention again covered over with a diaphra(3mb~ and there is a bead 96 with a fonn and function as noted hereinbefore. It ~eeps this part of the system sterile by sealing it off from the outside.
In this respect the edge l4 is at first only welded as far as the part ~8 on producing the bag l~ so that the part 86 that is produced by the two folds~f film, is Icept oyen and the connector 84 may be slipped thereinto at the ~eldment l4. That is to say, this edge weldment l~ is made ri~ht round the bag 10 so that the bag is sealed off. The part that is still open at edges 88, 9 ~nd 92 is then shut off at such edges as will be seen in figure 7, the inner ~pace 100 of this part 86 however being kept unwelded.
Il A useful efEect is produce(-3 if at the join or transition between the~
Iinner space 100 and the edge 92 a line of weakness 102 is produced, that may be ~torn open on pullin~ the ed~e 92, that is best made so that it may readily be l~ripped for tearing it of~ completely.
~l It is naturally possible to have more than one connector 84 nested within one part ~6 or however it is furthermore possible for more than one part ~86 to be placed round one connector 84. To take an example of this, in the ¦lexample oE the invention of figure l it would be possible to have two connectors lland two separate parts 86 and one filling opening ~8/ that would not be covered Iby such parts. On the other hand all the three openin~Js towards the bay may be~
completely covered by this part, the sort of weld produced being dependent on i~
the connectors are covered over by a diaphr~m or a hollow stop~r.
As a material Eor tl~e hose~ conrlectors 2~, 22 arl(l the m-lLl! par~s ';~J alld l 72 and furthermore the connector EV~ is used with a VAC level o~ preferrably 25 Ito 35 % by weight. It may be in the form of one of the products "I-lostalen", ~"Evatane" or "Alkathene" as noted hereinbefore.
I After cross linking by irradiation with gamna ray for example or by 'Iprocessing using the Sioplas method, a cross linked hose connector or male part~
~ill have been produced that may be thermally sterilized at temperatures up to lat least 120 degrees C, this being possible without any damage or weakening oE
~le welded seam 36, that has been produced before the cross linking operation.
I
Icross-linked corJolymer of an olefin and a vinyl acetate.
I~ The bag produced using the teachings of the invention may be made up of p~astic or resin materials that are very low in price, as for exampleIpolyethylene. The Eilm nee~ed for manufacturing the bag may be prodllced tyl Inormal processes for making film or blown film, and which for those in the art lare generally speakin3 simple and trouble-free.
'; I
, I I
Furthermore the hose, tllat is used for producing the pipe-like outlet¦
~structure, is made from very low-cost olefin starting materials, that are ~opolymerized with a certain level of vinyl acetate (VAC).
I~ On an increase in the level of VAC it is possible to get a sharp lincrease in the rebound resillence, that is a measure for the elasticity of the ~hose. ~!ose structures made of yolyolefin only are less good than this copolymer inasfar as they are not elastic enough and may not be ~oined up with different forms of connectors, such as a coupling and the like so as ~o give a join with a ~ fluid-tight seal or seating effect so that they do not keep to a very important ~IFondition in connection with medical apparatus. For this reason so far flexible ~inyl hose, that has these very good elasticity properties as noted, and 110 ~ther material, has had to be used.
If ~or example a copoly~ner of ethylene and vinyl acetate ~EV~) i5 used, lit will be seen that althougt) on increaSing the level of V~C the rel~o~
resilience is stepped up, there is a decrease io tlle melting point in the VAC
¦range of interest to under 100 degrees C. so that, if made with such hose ~onnection piece, such a bag would no longer be able to be sterilized.
Although it is kno~m that hose based on VAC containing polyolefins may ~ stabilized thermally by cross linking and that it is even possible for their !~lastic properties to be stepped up, those in the art are conscious of the fact ~that such cross linked hose structures are not able to be welded to the base or ¦~tarting polyole~in (of which the bags are made) by itself and that in fact no onnection or weldment is produced between the polyolefin and the cross linked ~opolymer that is made up of olefin and VAC.
j The surprising discovery has now been made ~ithin the framework of the ~resent invention that a polyolefin bag and a hose (that so far has not been ross linked) made of a copolymer of olefin, ~ore specially ethylene, and VAC
~ay be welded together. After the cross linking of the copolymer the weld or l ~oin is still in existence, that is to say it is not damaged by the cross linking and what is more is that the end product still has the properties thatl~e starting material had in the first place.
Il I
Il I
¦I PAGE
A fact that i5 to be more specially noted is that such cross linked ~iece of hose, that is welded into a polyethylene bag as an outlet nipple, hasthe good elasticity and thermal properties, which make it possible for a bag ofllthe present invention to be sterilized at high temperatures, as for example at ¦about 12a degrees C, and make quite certain that the hose connector piece makes ¦~a strong join so that coupling pieces fixed thereto may not be pulled off it.
It is seen rom this that such a sterilizable bag for medical purposes hasl mechanical properties that are at least equal to those of a nonnal flexible i vinyl or PVC bag. I
¦ A further point is that the new bag is free of plasticizer, because the j polyolefin materials normally used as a film material are made without the ¦
addition of any plasticizers. For this reason there is no chance of attack by microor~Janislns and in tllis connection ~he bag of the invention wilL be seen to ~t~ more hygienic in every possible respect than flexible vlnyl ~1-3s as currelltly ~in use.
Polyolefins that may be used as polymers for producing the bag of the present invention May for example be polymers produced from ethylene, propylene,Ibutylene and the like. T~le preferred olefin used as a starting material is ¦
,ethylene, that may be substituted with one or more groups.
I Possible substitutients in this respect are for example the methyl or~
~the ethyl group, the vinyl group and halogen atoms, more specially fluorine atoms .
Ethylene that has been polymerized to polyethylene is more specially preferred.
More specially used examples of polyolefins are polyethylene,polypropylene, poly-n-butylene, polyisobutylene,~l poly-4-methylpentene-1, chlorosulfonated polyethylene, polystyrene, halogenated ¦
Ipolyethylenes such as polyvinyl fluoride, polyvinylidene fluoride, and¦
¦polyvinylidene chloride, polymethyl metacrylate and the like. The olefins used jusecl for producing these polyolefins may furthermore by used in the form of Fopolymers with other vinyl compoullds, as Eor e~ample ethylene/propylene lastics, poly(ethylenevirlyl acetate), acrylonitrile/butadiene/styrene pol~ners, ethylene-propylene block pol~ner, styrene copolymers, copolymer containing ~inylidene fluoride, and copol~ners containing styrene.
Il Polyolefins are products of ~e present invention, that have been l~produced by the vinyl polymerization of ethylene that may be substituted if ¦desired. These products may furthermore have additions of small amounts of ¦Ifurther polymers, that are not, by and large, responsible for any undesired lleffects on, or any changes in the structure of these polyolefins. It is as an ¦lexample to have small additions of ethylene compounds substituted with styrene lor polyacrylonitrile The polyolefin products so produced are looked upon as ¦coming within the same ~roup as the polyolefins noted hereinbefore.
In the invent;on the preferred polyolefin used Eor the bac~s is oly~thylene, that may if ~Qsired have the additions of ~,mall amounts o vlnyl ~cetate in the onn of ethylene vinyl acetate copolymer. In such a case the ~evel of the vinyl acetate may be up to 10~ by weight.
More specially a medium to high density polyethylene (ML~ and ~A) is ~sed that normally will have been produced by low pressure polymerization. In ¦this respect the density will be in a range of 0.91 to 0.94 and more specially ~ill have a value of 0.935 g/cc.
I Furthennore the form of polyethylene that is more specially used in the invention has a high molecular wei~ht and a narrow molecular weic~llt distribution range.
In every case however care is to be taken to see that such polyolefins ~o not have a rnelting point under the sterilizing temperature of 110 to 120 ¦degrees C. More specially the melting range is to be over 116 de~rees C and ~ore limitedly is to be at 12~ to 124 de~rees C, while the Vicat softening ~emperature (DIN 53,460) is to be greater than llS degrees C.
In the case of the EVA polymer noted hereinbefore (copolymer oE ethylene l~nd vinyl acetate) there is a decrease in the melting point for every increase lin the vinyl acetate level so that such products have to undergo a cross linking -rocess, as will oe detailed hereinafter, tefore any sterilization op*rstion.
P~.GE 8 ~I The permeability of the polyolef;ns noted to water vapor and oxygen may ¦ be responsible Eor trouble conditions when solvents are stored Eor a long timeso that there may be an ;ncrease in the strength of the solution and oxygen may ~nake its way into the solution from outside and the dissolved components may be5loxidized, something that is more specially undesired in the case of amino acidsolutions so that steps have to be taken for putting an end to any such transferof oxygen.
For stopping any such transfer, a useful sealing effect may be produce:
l ~y coating the said polyolefin film of the bag on its outer face with one o:
10nore layers for lowering the permeability for water vapor and oxygen, the ~oating material beinq or example a metal ~ilm or another polymer. Such an ~uter layer or coating may furthermore be usefully used as a cJener~L saeaty ~neasure, inasfar as even i~ ~hey are very carefully pra~ucecl the~ bag ~ilms may jstill have pin holes, that are hard to see and may have an undesired effect on 15~the sterility of the solution put in the bag.
A further point is that such an outer coating may make the bag very much ~tronger physically so that it may be dropped from a height of some meters ~ithout bursting.
Usefully the film or Eoil used is of such a nature that it has a higher 2(~nelting point than the polymer next to the solution. Putting it cliEferently uch outer layer is not to be melted at the melting point o tl-e inner ancl there s for this reason no chance of its sticking to the welding or hot sealing tool.
rn this respect such an outer foil or film may be thought of as a pcarting film l ~n welcdin~ the inner film.
25'~ As a polymer for making such a laminated structure any of the polyolefins named hereinbefore may be used. ~lowever the preferred polymers are hose that have a low permeability to water vapor and a low permeability to ~xygen. Polymers coming ~1ithin such a group are for example polyamides, PVC, ~olyvinylidene chloride, polyvinyl fluoride, polytrifluorochloroethylene, 30~olyethylene terephthalate, polyesters and the like. Those which are more ~pecially preferred are polyamides, polyvinylidene chloride, polyethylene 2~
g terephthalat and polyesters.
A more specially used polyamide may be a polycaprolactam -tha-t may be processed and s-terilized using superheated steam at a -temperature of 120 to 140 degrees C. Q
useful effect is to be produced if this polyamide is free of stabilizing addi-tions and in this respect has a composition meeting the needs and conditions of food products industry.
The polymeric outer and inner films are best united using a laminating adhesive, such as polyvinylidene chloride or polyurethane. Such a polyurethane adhesive may usefully be a two componen-t adhesive, the first componen-t being a laminating adhesive and the second component being an additive lacquer.
From the point of view of process engineering the polyolefin used as the inner film be may produced as blown film and then bonded to the coating film using one of the said laminatlng adhesives, in which respect polyurethane is preferrecl for this pu.rpose.
lf the outer fllm ls :in the fo:rrn oF PVC the~
polyolefin F`ilm used :in the inverltion will make ce:rtain that there is no chance of the plasticizer present in the PVC
diFfusing through the laminating adhesive and the polyolefin film into the solution being stored in -the bag.
At 85% relative humidity and a temperature of 23 degrees C preferred laminates have a permeabili-ty to water vapor (as measured using the test noted in DIN 53,122) of less than 1. Such values are kept to by standard shee-ting with a thickness of 50 to 100 and more specially 75 microns in the case of polyolefin filrn and 20 to 100 or more specially 30 to 70 microns in the case of polymeric lamlnating fllm, such as a polyamide.
Furthermore in the case of such a preFerred laminate the permeability to oxygen is decreased and may be under a figure of 15 cc/sq m times the number of days times the pressure difference in bar.
Such films are for example marketed by Sengewald, Halle, Westfalen, under the name "Flexovac V 7l44"* and -from -the physiological point of view have been given approval by the West German Ministry of Health in Berlin and moreover by -the FDA in the United States for use in connection with food products and in * Trade Mark %~
eclicine As has been noted earlier, the polyolefin film next to the l;quid bottled in the bag is free of plasticizer and of any other addition that might~
~llbe a danger to health and more specially miyht make its way by diffusion into ¦
l¦the aqueous solution~ Furthermore the polyolefin ~ilm, that may if needed be ¦Icovered over with an organic laminatin~ film, is glass-clear and transparent and j ill have such properties after sterilization~ ~
AS a material of the outlet structure or nipple an olefin-vinyl acetate ¦
Icopolymer may be used. As polyolefins that may be produced from this olefin, it ¦
¦is possible to make use of the olefins named hereinbefore in connection with producing the ba~3. Such olefins have a level of vinyl acetate in the copol~ner I
of 5 to 4~ and more specially 8 to 35 or ev~n more limiteclly o~ 2~1 to 3~ '~ I)y¦
~eigtlt. ~s made cle~r earli~r, the melting ~oint of polyethylene c~oes dowl~ wl~h bn increase in the vinyl acetate level from about 125 degrees C to about 7 ~egrees C at a VAC level of 30g by weight. It goes without saying that at a sterilization temperature yreater than 1~0 degrees C such a hose will be melted ~nd for this reason would be useless. On the other hand the rebound elasticity ¦of such hose material desired goes up with an increase in the VAC level from 35¦to 55% in the case of a 30% VAC level.
j Moreover such a hose-like material containincJ V~C may be very readily ~elded to the material of the bag, if the polyolefin material used there~or is ~enerally or completely the same. The use of polyolefin materials that are l ~enerally the same for the connector piece and the bag is for this reason ¦Ipreferred~ More specially the material used for the outlet structure is ~opolymer of ethylene and vinyl acetate (EVA) with the weiyht ranges as noted hereinbefore, in which respect the bag material may well be polymerized ethyle~ne ~r propylene cornpounds. A preferred combination is one of EVA as the rnaterial 1jfor the outlet structure and polyethylene as the bag material with the weight jranges given hereinbefore.
EV~ is for example put on the market by I~OECHST A~l under the trade narne ~f "Hostalen LD/EVA" and by ICI under the trade name of "Evatane" ancl "Alkathene PAGE lll Il l EVAi.
~rhe production and processing of the materials or the bag may be' undertaken in a way generally used in the plas~ics art. For example, as madel llclear earlier, the bags may be produced from blown film, that is cut to size and then welded at the edges. Such a bag, that is not welded together at its edges ~ere the connection opening is to be placed, is then welded to a piece oE hose ¦lof a male part having the outlet opening or opening therein, such male partl ¦~being placed on a mandrel into the opened up ba~. Nextly the full edge which;
¦¦has so far not been welded is heat sealed to the inner hose piece or ~ale ¦connection piece. If there is more than one hose connection piece, such welding1 and connection operations are naturally undertalcen at the same time using j customized welding tools. I
11erein the wordlng "hose connection piece" is uscd in thc sense o~ a1 Ipiece o~ hose prodl1ci1lg the liquid connection between the space ~ithin t!~e ~kll:J~
and infusion apparatus, catheter, Lnjection syringe or the like that is joined 1up with the hose connection piece. The said wording is used herein as l~furthermore covering an inner part, that is welded in position within the bag 1 ¦¦and has at least one outlet opening without, however, such inner part having thel ¦¦form of a piece of hose running out from the edge of the said bag. Such an1 11inner part is slipped, li1ce a piece of hose, into the edge part of the hag where ¦
¦1the edges have 50 far not been welded together and then thermally united and ~welded to the bag.
¦~ The bags produced on these lines have generally the same properties as a ¦¦flexible vinyl or PVC bag with the di~ference however that the connection hose~nade of EVA would be ~elted on sterilization at over abou~ 80 degrees C so that~
thermal sterili~ation of such a bag would not be possible. On the other hand the weldment, that is fonned between the bag and the hose connection piece, is so stron~ that the piece oE hose would only be able to he taken out by force.
~ In order to ~ake it possible for the hose connection piece to be able to ~ sterilized, it has to be cross linked so that the ~ne:Lting point oE the hose and its elasticity are greatly increased. ~y way oE such cross linking ll Il ~
llprocessing it in fact becomes possible for the finished bag to be sterilized atl ~Itemperatures of up to about 12~ degrees C and thereover. Furthermore the cross I linlced hose has very much better elastic properties than a flexible vinyl hose,~
that normally has to be heated up before it rnay be slipped onto certain llconnection elements.
I A further discovery made in development of the present invention is the ¦fact that such cross linking is not responsible for unjoining the material where lit was welded, as might have seemed likely in the first place inasfar as cross ¦linked EVA may not be welded to polyolefin material, such as polyethylene, by 1 ¦¦itselfO
The cross linking operation may be undertalcen in a known way of cross ¦linking EV~. It may take place for ex;~mple by u5in~3 h1~3h energy radiation, a5 Eor ~xample usin-~ accelerated electrons alpha and gamma rays witt~ an enerJy o over 2.5 Mrad. More specially the operation will be undertaken usin~ a level o~
to 10 Mrad, the exact figure being dependent on the nature and thickness of the material to be cross linked.
The useful effect of such process step is that the bag, that has been ~
sealed and is generally free of pyrogens, is sterilized by the hi~h energy ¦
l irradiation so that a solution that has been sterilized beforehand may be filled llinto the bag, that is to say it is not necessary to undertake tllermal processing ~in an autoclave. A still further useful effect of the proces5ing by the use of radiation is that iE the polyethylene has not been completely polymeri2ed, or i~
the film of ~lich the bag is made has a small amount of EV~ therein, such ~naterial may be cross linked and be given better mechanical properties so that ~terilization temperatures as high as 130 degrees C may be used.
¦ A further possible way of causing cross linking is one using peroxides, ¦~s for example cumol peroxide or the like, that are decomposed by heating so llthat radicalic cross linking is started therebyO In this it is naturally ¦~ecessary for the production of the EVA hose, that is normally undertaken while Iheated, to be combined with the production of the bag, seeing that otherwise the ~ msterials would e cross linked and would then no longer be sble to be welded to the polye-thylene used as the ma-terial of the bag.
A further way of cross linking -that is as well based on the addition and decomposition of chemical compounds makes use oF silico-organic compounds, that are decomposed in a humid warm atmosphere and then have the effect o-F cross linking the EVA with the formation of silicon bridges. One example For -this Si cross linking process is the ~Sioplas process"* o-F ICI, in which the silico-organic compound is mixed into -the EVA
granules and the product is extruded as -the desired film or hose. In this case as well the cross linking takes some hours to some days dependent on the degree of humidi-ty used and the -tempera-ture. In Fact the cross linking operation may be undertaken in about one hour using a temperature of ove:r 8û
degrees C and a relative humidity of 10055.
This process as well naturally makes it necessary For the Film and the hose to be produced together and at the ba~ of the :invent:ion.
Of the poss:ible processes i'or undertak.ing cros~
linking, the method us.ing high energy radiation and process.incJ
using silico-organic cross linking compounds are preFerred.
A further fact to be specially noted is tha-t any sort of cross linking process may be used if it is such that the polyolefin hose (that is not so far cross linked and has been welded to the bag ma-terial) having a certain level oF VAC
may be cross linked.
Further cletails of the invention will be seen from the account now to be given using the -figures.
LIST OF Ti-lE DIFFERENT VIEWS OF T~IE F:CGUF~ES.
Figure 1 is a diagrammatic view of a bag f`or inf`usion purposes, as seen looking down onto the bag.
Figure 2 is a section taken on the line II - II of the figure 1.
Figure 3 is a view of the opening oF a hose-like connection head made of EVA.
Figure l~ is view looking down on-to part of a further * Trade Mark 2~7 ! PAGE 1 working exalnple of the invention in the form of a male part without a frangible cover.
¦l~igure 5 is a section taken on ~he line V - V of th~
¦¦ figure ~A
l~igure 6 is a view looking do~n on a further example, that is jl somewhat like the example of figure A.
¦~iyure 7 is view of part of a working example oE the invention as seen frGm the side, to make clear the design of the casing of a hose connection head.
l DETAILED ACCOUNT OF l~ORKIN~ EXAMPLES OF INVENrION.
Turning to the figures and more specially to figure 1, it will be seen that a bag 10 is in the form of a wall structure with an inner sl~ce 12, that l~ a welded edge 1~ running rigtlt tlle way rowld it. 'l~le ha~ 1~ has. two ollt:Lqt ¦~p~nings 16 and l8, that in each case are fitted with a hose connector or Ibonnection head numbered 20 in the one and 22 in the other case, such connectors ~orming spouts or nipples. It is by way of these connectors that the liquid to ~e stored, as for example an infusion solution or blood, may be run into the inner space or chamber 12 of the ba~ l~. In this respect it is possible for ~nly one of the connectors or the t~o of them to be used Eor the inlet of the Liquid.
Such a bag has so far normally been manufactured by firstLy placin~ the wo cut 0l3t pieces of film together face to face and then welcling them together , ~long most of the edye l4 but not at the outlets 16 and 1~. Nextly the ~onnectors 20 and 22 are slipped into the outlets 16 and 18 using a mandrel (not ~igured) and they are then welded along their outer faces of the bag film. As ~oted earlier in this connection, the preferr~l material for the bag is ~lyethylene and the preferred material for the hose material is EV~. After ~ein~ welded together the EVA material is cross linlced, this being done more ~pecially with the help of ionizing radiation.
3~ I For infusion purposes the hose connector 20 is filled up with a hollow Itopprr 23 designed for such iniusion. ~lis stopper has a fran3ible sterile Il 2~ 1 ;diaphragrn 24 that is normally made of chlorobutyl rubber and may readily be¦
pierced by an injection needle. This diaphragm 24 is covered over with a guard Ithimble 25 for hygienic reasons after the diaphragm has been fixed on the ¦stopper 23 by some known method. ~e stop~er is nonnally Inade of ¦~lycarbonate. -The other hose connector 22 may be fitted with a syringe stopper 2~ or plug, that is best made of polycarbonate material as well and has an inner part 27~ made for example of latex, that is readily pierced by a hollow needle.
I, Once these stoppers 23 and 26 have been forced into the connectors 2X
land 22 made of cross linked E~ , that are widened out somewhat, they may only be ~lled out again by using a very strong force and they are in fact firmly seated ~d jarrmed in positionO
In view o the fact that the ~1~ is nonnally supported in use by han~Jin~
~t up with the hose connectors 20 an~ 22 pointin~3 c]ownwards so that the ~olutlon in the bag may be run out Erom it without any trouble, the edge 14 of the bag 10, that is opposite to the hose connectors 2~ and 22 has an eye 28 so that the op end of the bag 1~ may be hooked onto a support part such as a stand or the ~ike for keepinq the bag in the desired position where it is used.
Il As part of the preferred workiny example of the invention, that is to be ~een on a ~reater scale in figure 2, the rnaterial of the bag la is a laminate 30 ~hade up of Eilm layers sanclwiched together. In line with one rnore specially ~reEerred teaching of the present invention, this laminate has on its side next ~o the solution a layer of polyethylene film 34, that will nonllally have a ¦Lhickness of 30 to 100 microns and more specially 75 microns. The preferred ~lyethylene materialhas a density of 0.935 g/cc, a melting range of 121 to 124 ~egrees C and a Vicat softening temperature oE rou~hly 118 degrees C.
¦1 on this polyethylene film 32 a polyalnide film 3~ is bonded using a ¦~olyurthane adhesive, such film 34 having a thickness in the range of about 30 ~ 70 microns.
~ From figure 2 it will furthermore be clear that near the joins with the ose connectors 20 and 22 the polyethylene film 32 has a welded seam 36 Eonning Il %~
~la strong and homogeneous bond between the foil and the connectors 20 and 22 so ¦Ithat there is not the least danger of the connectors being pulled out of the bag 10 without serious damage to bag 1~ generally.
! A Eurther working example of the hose connectors 20 a~d 22 will be seen ¦lin figure 3 in ~hich only the end parts are viewed, that is to say without ¦Iseeing the weld part ormin~ a join with the bag rnaterial. me end part 38 of ¦the hose connectors 20 and 22 has, near the end 9~ that is pushed into the bag, ; diaphragm 42 running across the end 40 and shuttinc3 off the inside of the bag l~ompletely from the outside. This diaphragm 42 is pierced open, when the bag is ¦~sed, by the point of an infusion apparatus that is not figured, to let off ¦liquid from the bag 10. Because as noted the bag will normally be hanging ~ pside down when used, it is necessary to have a seal between the point ~x~rt o~
the lnfusion apparatus ancl the wall o~ the ho~e as otilerwise ther~ would b~ a langer oE the liquid rullnin-3 out freely. ~o this end the inner face ~ the hose ear the opening 40 has a ring-like bead ~4 designed to be pressed against the ~ int before piercing the diaphragm 42.
Such hose connectors 20 and 22 having a diaphragm 42 will be produced by known injection molding process before being welded to the bag 10. A mandrel, LPecially designed so that the diaphragm 42 will not be pierced thereby, is used Eor slipping the connectors 20 and 22 into the outlet openings 16 and 18.
¦ Because, after being sterilized in an autoclave, the cliaphragn~ 42 ls to Ipe kept in a sterile condition, the opening A~ is covered over with a skin ~6 ~hat may be peeled off when this is desired.
I Tha form of the invention to be seen in figure 3 naturally has to have a ~illing opening ~8 at the edge of the bag 1~, such opening being shaded in ~igure 1 and not being welded over when the rest of the edge of the ~ag is ~elded, as was the case with the outlet openings 16 and 18. ~e opening ~8 nakes it possible for the bag 10 to be filled and after filling has taken place s is shut by welding or hot sealed in a normal way.
¦1 A still further working example of the invention is to be seen in Eigures 4 and S that has a plug piece SE that ie generally made up oE tl-e plu3 body 52 that has two convex sides (fi~ure 9)~ Such a form makes it sirnpler for lithe welding to the inner film 32 to be undertaken at the edges to get a more or ¦less completely smooth join between the welded edge 14 and the inner pluq body ~52.
~ is plu~ body 52 as figured will be seen from figures 9 and 5 to have ~nlet and outlet openinqs 59 and 56~ Furthermore it has a filling opening 58 on ~hich some observations are to be made hereinafter.
The inlet and outlet openin~s 54 and 56 are each joinec1 up with a l~ose-like connector 6~ and 62 or headpiece. Such connectors may be of the same ¦besign as in the worlcing examples of the invention to be seen in figlJres l ancl i~. In Eact the connectors may again have diaphragms ~ and ring-~like beac1s 66, ~uch a system then makin~J the eilling opening 58 nece5sary, th~t may be safely ~toppercd with a plu~ of the rl~ht ~orm after filling h1s taken plelce~
¦ In the workin~ example oE the invention to be seen in fkJure 5 the ed~es ~f the connectors 60 and 62 are in each case joined up by way of lines of , ~eakness 68 with a tear-off cover 70, that on the one hand keeps the diaphragm sterile till the time of use and on the other hand is so designed that it may be readily torn off before such use.
¦~ It is naturally ~ossible for the example of the invention of Eigures ¦, ~nd 5 to be designed without diaphragms 54, the tear-ofE cover 7~ and the beac]s ;6, this Inaking t~le Eillinq opening ~mnecessary. It furthermore ~oes without ,aying that it is possible to have one or rnore connectors 6~ or 62.
¦ Figure ~ is a view of a further form of such an inner or male part 72 ~orming part of the present invention. It is generally in the form of a male ~ody 74 that is convex on its two opposite sides so that its fonn is by and Large the same as that of the male body 52. The thickness of these male bodies 2 and 7~ is such in this respect that thickness-wise they are lined up with the ~elded edge 14 so that tl1ere are no outwardly running parts of the bodies 52 and ~.
3 In the case of the inner or male body 7~ to be seen in figure 6 there ~re for this reason no hose-like connectors 60 and 62; that is to say the male PAGE l8 body 7q only has two inlet and outlet openings 76 and 78 running through it from~end to end. In these holes it i5 then possible Eor the stoppers 23 or 26 of figure l to be placed to give a Eurther useEul efEect~ On the other hand it is naturally possible for tl1e inlet and outlet openings 76 and 78 to be shut off in ~¦the same way as in the example of figure 3, that is to say using a diaphragm 80, that is best placed on the lower surface oE the male ~)dy 7~ In such a case there will again be a filling opening 82, tha~ is marked in broken lines in ~figure 6. This filling opening 82 may again be shut off using a stopper oE the ¦right size. The inlet and outlet openin(3s 7~ and 78 may, if a diaphragm ~'3a is ¦;used, be covered over with a piece of skin or diaphragm that may be peele~] oEf, ¦to keep the inlet and outlet openin~3s 7~ and 78 sterile, such skin being place~
¦~ver the male body 74.
Fi~ure 7 is a section view oE a Eurther working example of tl~e pr~'sent invQrltiol1 which is clesignlad or1 qenerally the same lines as the example oE E~-Jure ~ only a hose-like connector 8~ being seen here, that has been welded into the g 10 at the at the edge thereof l4.
¦ The section of figure 7 as part of the bag 10 is generally on the same ines as the part of the bag 10 to be seen in figure l, with the diEEerence ~however that at the connectors ~4 there are two folcl-like parts 86 placed on top of each other. When their edges have been weldecl together at 88, 9~ and 92 they are completely and liqu;d tig~tly placed round the connector ~ 1e last-named is in this form of the invention again covered over with a diaphra(3mb~ and there is a bead 96 with a fonn and function as noted hereinbefore. It ~eeps this part of the system sterile by sealing it off from the outside.
In this respect the edge l4 is at first only welded as far as the part ~8 on producing the bag l~ so that the part 86 that is produced by the two folds~f film, is Icept oyen and the connector 84 may be slipped thereinto at the ~eldment l4. That is to say, this edge weldment l~ is made ri~ht round the bag 10 so that the bag is sealed off. The part that is still open at edges 88, 9 ~nd 92 is then shut off at such edges as will be seen in figure 7, the inner ~pace 100 of this part 86 however being kept unwelded.
Il A useful efEect is produce(-3 if at the join or transition between the~
Iinner space 100 and the edge 92 a line of weakness 102 is produced, that may be ~torn open on pullin~ the ed~e 92, that is best made so that it may readily be l~ripped for tearing it of~ completely.
~l It is naturally possible to have more than one connector 84 nested within one part ~6 or however it is furthermore possible for more than one part ~86 to be placed round one connector 84. To take an example of this, in the ¦lexample oE the invention of figure l it would be possible to have two connectors lland two separate parts 86 and one filling opening ~8/ that would not be covered Iby such parts. On the other hand all the three openin~Js towards the bay may be~
completely covered by this part, the sort of weld produced being dependent on i~
the connectors are covered over by a diaphr~m or a hollow stop~r.
As a material Eor tl~e hose~ conrlectors 2~, 22 arl(l the m-lLl! par~s ';~J alld l 72 and furthermore the connector EV~ is used with a VAC level o~ preferrably 25 Ito 35 % by weight. It may be in the form of one of the products "I-lostalen", ~"Evatane" or "Alkathene" as noted hereinbefore.
I After cross linking by irradiation with gamna ray for example or by 'Iprocessing using the Sioplas method, a cross linked hose connector or male part~
~ill have been produced that may be thermally sterilized at temperatures up to lat least 120 degrees C, this being possible without any damage or weakening oE
~le welded seam 36, that has been produced before the cross linking operation.
I
Claims (43)
OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A polyolefin film storage bag for storing liquids, having at least one opening of hose-like structure welded thereto said at least one structure comprising a cross linked copolymer of olefin and vinyl acetate.
2. The bag as claimed in claim 1 wherein said polyolefin is selected from the group: polyethylene, polypropylene, poly-n-butylene, polyisobutylene, poly-4-methylpentene-1, chlorosulfonated polyethylene, polystyrene, halogenated polyethylene, polymethyl metacrylate, copolymers thereof.
3. The bag as claimed in claim 2 wherein said polyolefin is polyethylene with a density of 0.9 to 0.94.
4. The bag as claimed in claim 3 wherein the melting range of the polythylene is over 116 degress C.
5. The bag as claimed in claim 4 wherein said polyethylene is laminated to a film selected from the group:
polyamide film, polyvinylidene chloride film, polyethylene terephthalate film and polyester film and said polyethylene layer provides the inner surface of the bag.
polyamide film, polyvinylidene chloride film, polyethylene terephthalate film and polyester film and said polyethylene layer provides the inner surface of the bag.
6. The bag as claimed in claim 5 wherein said polyethylene film and said film laminated thereto have an overall thickness of up to 0.2 mm, the polyethylene film having a thickness of 50 to 100 microns and the film laminated thereto having a thickness of 20 to 100 microns.
7. The bag as claimed in claim 1 wherein the hose connector or male body is made up of a copolymer of 95 to 60%
by weight of olefin and 5 to 40% by weight of vinyl acetate.
by weight of olefin and 5 to 40% by weight of vinyl acetate.
8. The bag as claimed in claim 7 wherein said copolymer has an olefin level of 80 to 68% by weight and a vinyl acetate level of 20 to 32% by weight.
9. The bag as claimed in claim 2 wherein the polyolefin of the bag material and the polyolefin component of the copolymer are the same.
10. The bag as claimed in claim 9 wherein the olefin is ethylene.
11. A polyolefin storage bag for storing liquids having at least one opening of hose like structure said at least one structure comprising a previously uncross-linked copolymer of 60-95% by weight of olefin and 5-40% by weight of vinyl acetate first welded to said bag and then cross-linked.
12. The bag as claimed in claim 11 wherein the cross linking has been undertaken with high energy radiation.
13. The bag as claimed in claim 1 wherein the hose-like structures are designed to be joined with infusion stoppers or with syringe stoppers.
14. The bag as claimed in claim 1 wherein the openings in said structure are shut off with a piercable diaphragm.
15. The bag according to claim 1 wherein said hose like structure comprises a hose like inlet opening and a hose like outlet opening.
16. The bag in accordance to claim 1 wherein the hose like structure comprises a solid male insert means having at least one opening therethrough for communicating between the interior and the exterior of the bag.
17. The bag as claimed in claim 14 wherein the portion of the opening outwardly of the diaphragm is closed by a closing means.
18. The bag as claimed in claim 17 wherein said closing means is a weld or a stopper.
19. The bag as claimed in claim 14 wherein the hose like structure is provided with an internal narrowing means and said diaphragm is placed inwardly of said narrowing means.
20. The bag as is claimed in claim 17 wherein said closing means is removable.
21. The bag as is claimed in claim 1 wherein the outer ends of said openings are enclosed by portions of the edges of said bag welded around them.
22. A polyethylene film storage bag for storing liquids having at least one opening of hose like structure welded thereot, said at least one structure comprising a radiation cross-linked copolymer of 60 to 95% by weight of polyethylene and 5 to 40% by weight of vinyl acetate.
23. A polyethylene storage bag for storing liquids having at least one opening of hose-like structure, said at least one structure comprising a previously uncross-linked copolymer of 60 to 95% by weight of polyethylene and 5 to 40%
by weight of vinyl acetate first welded to said bag and then cross-linked by high energy radiation to provide a sterilizable ethylene vinyl acetate hose-like structure.
by weight of vinyl acetate first welded to said bag and then cross-linked by high energy radiation to provide a sterilizable ethylene vinyl acetate hose-like structure.
24. A laminar film storage bag comprising a laminate of polyethylene on the inner side and polyamide on the outer side for storing liquids having at least one opening of hose-like structure welded thereto, said at least one structure comprising a cross-linked copolymer of 60 to 95% by weight of polyethylene and 5 to 40% by weight of vinyl acetate.
25. A laminar storage bag comprising polyethylene sheet on the inner side and a polyamide sheet on the outer side for storing liquids, having at least one opening of hose-like structure, said at least one structure comprising a previously uncross-linked copolymer of 60 to 95% by weight of polyethylene and 5 to 40% by weight of vinyl acetate first welded to said bag and then cross-linked by high energy radiation to provide a sterilizable ethylene vinyl acetate hose-like structure.
26. A polyolefin film storage bag for storing liquids, having at least one opening of hose-like structure welded thereto, said at least one structure comprising a cross linked coploymer of 60-95% by weight of olefin and 5-40% by weight of vinyl acetate.
27. The bag as claimed in claim 26 wherein said polyolefin is selected from the group: polyethylene, polypropylene, poly-n-butylene, polyisobutylene, poly-4-methylpentene-1, chlorosulfonated polyethylene, polystyrene, halogenated polyethylene, polymethyl metacrylate, copolymers thereof.
28. The bag as claimed in claim 27 wherein said polyolefin is polyethylene with a density of 0.9 to 0.94.
29. The bag as claimed in claim 28 wherein the melting range of the polythylene is over 116 degress C.
30. The bag as claimed in claim 29 wherein said polyethylene is laminated to a film selected from the group:
polyamide film, polyvinylidene chloride film, polyethylene terephthalate film and polyester film and said polyethylene layer provides the inner surface of the bag.
polyamide film, polyvinylidene chloride film, polyethylene terephthalate film and polyester film and said polyethylene layer provides the inner surface of the bag.
31. The bag as claimed in claim 30 wherein said polyethylene film and said film laminated thereto have an overall thickness of up to 0.2 mm, the polyethylene film having a thickness of 50 to 100 microns and the film laminated thereto having a thickness of 20 to 100 microns.
32. The bag as claimed in claim 26 wherein said copolymer has an olefin level of 80 to 68% by weight and a vinyl acetate level of 20 to 32% by weight.
33. The bag as claimed in claim 27 wherein the polyolefin of the bag material and the polyolefin component of the copolymer are the same.
34. The bag as claimed in claim 33 wherein the olefin is ethylene.
35. The bag as claimed in claim 26 wherein the hose-like structures are designed to be joined with infusion stoppers or with syringe stoppers.
36. The bag as claimed in claim 26 wherein the openings in said structure are shut off with a piercable diaphragm.
37. The bag according to claim 26 wherein said hose like structure comprises a hose like inlet opening and a hose like outlet opening.
38. The bag in accordance to claim 26 wherein the hose like structure comprises a solid male insert means having at least one opening therethrough for communicating between the interior and the exterior of the bag.
39. The bag as claimed in claim 36 wherein the portion of the opening outwardly of the diaphragm is closed by a closing means.
40. The bag as claimed in claim 39 wherein said closing means is a weld or a stopper.
41. The bag as claimed in claim 36 wherein the hose like structure is provided with an internal narrowing means and said diaphragm is placed inwardly of said narrowing means.
42. The bag as is claimed in claim 39 wherein said closing means is removable.
43. The bag as is claimed in claim 26 wherein the outer ends of said openings are enclosed by portions of the edges of said bag welded around them.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DEP3200263.7 | 1982-01-07 | ||
| DE3200263 | 1982-01-07 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1189027A true CA1189027A (en) | 1985-06-18 |
Family
ID=6152712
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000419050A Expired CA1189027A (en) | 1982-01-07 | 1983-01-07 | Bag for the storage of liquids |
Country Status (18)
| Country | Link |
|---|---|
| US (1) | US4561110A (en) |
| EP (1) | EP0083778B1 (en) |
| JP (1) | JPS58169466A (en) |
| AR (1) | AR229630A1 (en) |
| AT (1) | ATE30673T1 (en) |
| AU (1) | AU555823B2 (en) |
| BR (1) | BR8300049A (en) |
| CA (1) | CA1189027A (en) |
| DD (1) | DD209389A5 (en) |
| DE (1) | DE3277609D1 (en) |
| DK (1) | DK158705C (en) |
| ES (1) | ES8402788A1 (en) |
| FI (1) | FI78611C (en) |
| HU (1) | HU187006B (en) |
| NO (1) | NO157404C (en) |
| PL (1) | PL240077A1 (en) |
| YU (1) | YU45123B (en) |
| ZA (1) | ZA8369B (en) |
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-
1982
- 1982-12-21 DE DE8282111877T patent/DE3277609D1/en not_active Expired
- 1982-12-21 EP EP82111877A patent/EP0083778B1/en not_active Expired
- 1982-12-21 AT AT82111877T patent/ATE30673T1/en not_active IP Right Cessation
-
1983
- 1983-01-05 US US06/455,868 patent/US4561110A/en not_active Expired - Lifetime
- 1983-01-05 ES ES518784A patent/ES8402788A1/en not_active Expired
- 1983-01-05 NO NO830022A patent/NO157404C/en not_active IP Right Cessation
- 1983-01-06 HU HU8340A patent/HU187006B/en unknown
- 1983-01-06 BR BR8300049A patent/BR8300049A/en not_active IP Right Cessation
- 1983-01-06 AR AR291796A patent/AR229630A1/en active
- 1983-01-06 DK DK002783A patent/DK158705C/en not_active IP Right Cessation
- 1983-01-06 ZA ZA8369A patent/ZA8369B/en unknown
- 1983-01-06 YU YU19/83A patent/YU45123B/en unknown
- 1983-01-07 CA CA000419050A patent/CA1189027A/en not_active Expired
- 1983-01-07 FI FI830046A patent/FI78611C/en not_active IP Right Cessation
- 1983-01-07 PL PL24007783A patent/PL240077A1/en unknown
- 1983-01-07 AU AU10222/83A patent/AU555823B2/en not_active Expired
- 1983-01-07 DD DD83247101A patent/DD209389A5/en unknown
- 1983-01-07 JP JP58000540A patent/JPS58169466A/en active Granted
Also Published As
| Publication number | Publication date |
|---|---|
| EP0083778A2 (en) | 1983-07-20 |
| AR229630A1 (en) | 1983-09-30 |
| EP0083778A3 (en) | 1985-05-08 |
| EP0083778B1 (en) | 1987-11-11 |
| ES518784A0 (en) | 1984-02-16 |
| DK2783A (en) | 1983-07-08 |
| AU555823B2 (en) | 1986-10-09 |
| DK158705B (en) | 1990-07-09 |
| DD209389A5 (en) | 1984-05-09 |
| FI830046L (en) | 1983-07-08 |
| US4561110A (en) | 1985-12-24 |
| YU1983A (en) | 1988-04-30 |
| BR8300049A (en) | 1983-09-20 |
| ZA8369B (en) | 1983-11-30 |
| HU187006B (en) | 1985-10-28 |
| DK2783D0 (en) | 1983-01-06 |
| JPH049059B2 (en) | 1992-02-19 |
| AU1022283A (en) | 1983-07-14 |
| YU45123B (en) | 1992-03-10 |
| DE3277609D1 (en) | 1987-12-17 |
| NO157404C (en) | 1988-03-23 |
| NO830022L (en) | 1983-07-08 |
| FI830046A0 (en) | 1983-01-07 |
| FI78611C (en) | 1989-09-11 |
| ES8402788A1 (en) | 1984-02-16 |
| PL240077A1 (en) | 1983-09-12 |
| NO157404B (en) | 1987-12-07 |
| JPS58169466A (en) | 1983-10-05 |
| ATE30673T1 (en) | 1987-11-15 |
| FI78611B (en) | 1989-05-31 |
| DK158705C (en) | 1990-11-26 |
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| MKEX | Expiry |