DK145752B - CUSHION PUSH FOR USE AS A PACKAGE FOR AN OSTOMI DEVICE AND PROCEDURE FOR PRODUCING THE SAME - Google Patents
CUSHION PUSH FOR USE AS A PACKAGE FOR AN OSTOMI DEVICE AND PROCEDURE FOR PRODUCING THE SAME Download PDFInfo
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- DK145752B DK145752B DK452177A DK452177A DK145752B DK 145752 B DK145752 B DK 145752B DK 452177 A DK452177 A DK 452177A DK 452177 A DK452177 A DK 452177A DK 145752 B DK145752 B DK 145752B
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Description
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Den foreliggende opfindelse angår en lukkepude til anvendelse som pakning for en ostomi-anordning og dannet ud fra et om-sætningsprodukt mellem en acrylforbindelse og en glycol og en fremgangsmåde til fremstilling af en sådan lukkepude.The present invention relates to a closure pad for use as a gasket for an ostomy device and formed from a reaction product between an acrylic compound and a glycol and a process for making such a closure pad.
5 Ved visse underlivskirurgiske metoder, såsom colostemi, ile-ostomi og ureterestomi, dannes en åbning i væggen af underlivet, hvor igennem der føres et dræn til de indre hulrum i underlivet. Drænet har til formål at fjerne spildvæske fra legemet og omfatter en frontplade eller ring, der omgiver dræ-10 net, samt en drænpose monteret til at modtage væsken. En lukket pude eller pakning i form af en ring anvendes mellem huden på patienten og frontpladen for at forhindre utætheder og for at holde giftige væsker borte fra de tilgrænsende dele af legemet samt for at holde anordningen på plads.5 Certain abdominal surgical methods, such as colostomy, ile ostomy and ureterestomy, form an opening in the wall of the abdomen, through which a drain leads to the internal cavities of the abdomen. The drain is intended to remove waste liquid from the body and includes a front plate or ring surrounding the drain, as well as a drain bag mounted to receive the liquid. A closed pad or gasket in the form of a ring is used between the skin of the patient and the faceplate to prevent leaks and to keep toxic fluids away from the adjoining parts of the body as well as to keep the device in place.
15 Selv om der har været anvendt forskellige materialer til fremstilling af lukkepuder for ostomi-anordninger, er puder baseret på indføring af karaya-pulver for tiden meget anvendt.15 Although various materials have been used to make closure pads for ostomy devices, pillows based on the introduction of karaya powder are currently widely used.
En pude eller pakning af denne art er omtalt i USA patentskrift nr. 3 302 647 og nr. 3 980 084. Karaya har dog visse 20 ulemper. Det er et næringsstof, der er i stand til at under støtte væksten af mikroorganismer, ikke blot under anvendelsen, men ved forurening under forudgående lagring. Karaya-præparater mangler sammenhængningsevne og kan derfor nedbrydes til stykker, der kan tilstoppe den ventil, som i nogle til-25 fælde findes i den benyttede drænpose. Det er endvidere vanske ligt at danne en lukkepude i en anden form end en flad ring. Karaya-præparater bliver i våd tilstand glatte, således at et specielt klæbemiddel kan være påkrævet for at hindre lukkepuden i at glide omkring og give utætheder. Karaya lader sig 30 ikke let vaske bort fra huden, men kan kun fjernes ved skrab- ning.A pillow or pack of this kind is disclosed in United States Patent Nos. 3,302,647 and 3,980,084. However, Karaya has some 20 drawbacks. It is a nutrient capable of supporting the growth of microorganisms not only during use, but by contamination during prior storage. Karaya preparations lack cohesiveness and can therefore be broken down into pieces that can clog the valve, which in some cases is found in the drainage bag used. Furthermore, it is difficult to form a closure pad in a form other than a flat ring. Karaya preparations get wet in the wet state, so a special adhesive may be required to prevent the closure pad from sliding around and causing leaks. Karaya 30 is not easily washed away from the skin, but can only be removed by scraping.
Den fra USA patentskrift nr. 3 980 084 kendte ostomipakning er fremstillet på basis af et hydroxyalkylacrylat eller -meth-acrylat og en glycol. Denne kendte pakning er mindre god i 2 145752 teknisk henseende og anvendes som nævnt fortrinsvis i forbindelse med karaya-pulver, hvilket som nævnt er mindre hensigtsmæssigt. Anvendt uden karaya-pulver er den ineffektiv.The ostomy gasket known from US Patent No. 3,980,084 is made from a hydroxyalkyl acrylate or methacrylate and a glycol. This known package is less good in technical terms and is used, as mentioned, preferably in connection with karaya powder, which, as mentioned, is less convenient. Used without karaya powder, it is ineffective.
USA patent nr. 3 640 741 angår en plastsammensætning, der er 5 egnet til en lukkepude for en ostomi-anordning, fremstillet .ved omsætning af carboxymethylcellulosegummi eller alginat-gummi med en polyol til dannelse af en plastic-gel. Carboxy-methylcellulosegummiproduktet understøtter ikke bakterievæksten, og alginatgummiproduktet understøtter bakterievækst i 10 ringe grad. Det har dog vist sig, at de foretrukne materialer . bliver glatte i våd tilstand, og at materialerne brydes i stykker, der falder ned i drænposen. Der er også behov for at forbedre egenskaber ved de fra patentskriftet kendte materialer.US Patent No. 3,640,741 relates to a plastic composition suitable for an ostomy device closure pad made by reacting carboxymethyl cellulose rubber or alginate rubber with a polyol to form a plastic gel. The carboxy-methylcellulose rubber product does not support bacterial growth, and the alginate rubber product supports bacterial growth to a small extent. However, it has been found that the preferred materials. becomes slippery in wet condition and the materials break into pieces that fall into the drainage bag. There is also a need to improve the properties of the materials known from the patent.
Opfindelsen angår således en lukkepude af den i krav l's ind-15 ledning angivne art og en fremgangsmåde til fremstilling deraf. Lukkepuden er ejendommelig ved det i krav l's kendetegnende del anførte og fremgangsmåden til fremstilling deraf ved det i krav 2's kendetegnende del anførte.The invention thus relates to a closure pad of the kind specified in the preamble of claim 1 and to a method of making it. The closure pad is characterized by the characterizing part of claim 1 and the method of manufacture thereof by the characterizing part of claim 2.
Lukkepuden er særlig hensigtsmæssigt udformet som en ring 20 med en central åbning til indsætning af et kirurgisk dræn, hvilken ring er anbragt mellem huden og en ostomi-anordning til opnåelse af en pakning derimellem.The closure pad is particularly conveniently designed as a ring 20 with a central opening for insertion of a surgical drain, which ring is disposed between the skin and an ostomy device to provide a gasket therebetween.
Da materialet ikke er et næringsmiddel for mikroorganismer, vil det ikke blive forurenet af sådanne organismer under op-25 bevaringen eller anvendelsen i forbindelse med legemet, såsom når det benyttes til en pakningsring i forbindelse med drænåbning .Since the material is not a nutrient for microorganisms, it will not be contaminated by such organisms during storage or use in connection with the body, such as when used for a gasket opening in connection with drainage.
Materialet har den enestående fordel at blive klæbrigt i fugtig tilstand og at bevare klæbrigheden og gode vedhæng- 30.. ningsegenskaber, efterhånden som det opløses. Sådanne egen skaber er fordelagtige for en pakning til en ostomi-anordning, 3 145752 fordi de gør det muligt at sikre et fortsat lukke mellem anordningen og huden, og anordningen sikres på plads med minimal bevægelse omkring drænet.The material has the unique advantage of becoming sticky in a moist state and maintaining the tackiness and good adhesive properties as it dissolves. Such self-assemblies are advantageous for a package for an ostomy device, because they enable continued closure between the device and the skin, and the device is secured in place with minimal movement around the drain.
En anden fordelagtig egenskab ved det omhandlede materiale er 5 sammenhængningsevnen. Denne egenskab gør det muligt at støbe materialet i en foretrukken form uden risiko for nedbrydning.Another advantageous feature of the present material is the cohesiveness. This feature allows the material to be molded in a preferred form without the risk of decomposition.
En lukkepude dannet af materialet vil derimod opløses gradvis i kontakt med legemsvæsker. Lukkepuden har en væsentlig længere holdbarhed end de ovennævnte hidtil kendte lukkepuder.A sealing pad formed by the material, on the other hand, will gradually dissolve in contact with body fluids. The closure pad has a significantly longer shelf life than the previously known closure pads mentioned above.
10 Det nye materiale er forholdsvis blødt og eftergiveligt, således at der kun er et minimalt ubehag for patienten, der anvender ostomi-anordningen. Materialet, som hænger ved huden eller klæber efter anvendelsen, fjernes let ved vask med sæbe og vand.The new material is relatively soft and resilient so that there is only minimal discomfort to the patient using the ostomy device. The material that hangs on the skin or adheres after use is easily removed by washing with soap and water.
15 Lukkepuden ifølge opfindelsen har en lang holdbarhedstid i modsætning til karaya-produkter, der kun er begrænset holdbare og hærder under opbevaring.The closure pad according to the invention has a long shelf life as opposed to karaya products which are only limited shelf life and harden during storage.
Opfindelsen skal i det efterfølgende illustreres nærmere ved hjælp af tegningen, hvor 20 fig. 1 viser en del af en ostomi-anordning set forfra og med en lukkepude ifølge opfindelsen, fig. 2 er et tværsnit af anordningen og lukkepuden, taget efter linien 2-2 i fig. 1, og fig. 3 er en perspektivisk afbildning, delvis gennembrudt 25 og i tværsnit.The invention will now be further illustrated by way of the drawing, in which: FIG. 1 is a front view of a part of an ostomy device with a closure pad according to the invention; FIG. 2 is a cross-sectional view of the device and closure pad taken along line 2-2 of FIG. 1, and FIG. 3 is a perspective view, partially pierced 25 and in cross-section.
Med henvisning til tegningens fig. 1 og 2 ses en ostomi-anordning 10 af en type, som er nærmere beskrevet i USA patent nr. 4054140, og som omfatter en ringformet pude 12, dannet af det omhandlede plastmateriale fremstillet ved frem- 4 145752 gangsmåden ifølge opfindelsen og beskrevet i det efterfølgende. Anordningen 10 omfatter en ringformet frontplade eller holder 14 af forholdsvis stift og hårdt materiale, såsom plast. Holderen omfatter et fladt skivelignende ringformet 5 legeme 16 med en central cirkulær åbning 18 derigennem. En cirkulær flange 20 står i forbindelse med legemet 16 og ragende på tværs ud derfra langs den indre periferi. To sædvanligvis rektangulære ydre flader 22 er sammenhængende med legemet 16 og rager radialt ud derfra i diametralt modsatte 10 retninger. Hvert af ørerne er udstyret med en aflang udskæring 24 beregnet til fastgøring af tappe til et bælte eller en strimmel, der ikke er vist, hvormed anordningen 10 kan spændes fast på patientens legeme.Referring to FIG. Figures 1 and 2 show an ostomy device 10 of a type further described in U.S. Patent No. 4054140 and comprising an annular pad 12 formed from the present plastic material made by the method of the invention and described in the present invention. Subsequently. The device 10 comprises an annular front plate or holder 14 of relatively rigid and hard material such as plastic. The holder comprises a flat disc-like annular body 16 with a central circular opening 18 therethrough. A circular flange 20 communicates with the body 16 and projects transversely therefrom along the inner periphery. Two usually rectangular outer faces 22 are contiguous with the body 16 and project radially outward therefrom in diametrically opposite 10 directions. Each of the ears is provided with an elongate cutout 24 for attaching pins to a belt or strip, not shown, by which the device 10 can be clamped to the patient's body.
En drænpose 26, der kun er vist brudstykkevis, er fastgjort 15 til anordningen til opsamling af spildvæske fra legemet. Posen 26 omfatter en bagvæg 28 med en cirkulær åbning 30, som indgår i flangen 20. Bagvæggen 28 er sikret til frontpladen 14 med en elastomer klæbrig ring 32. Modsatte sider af ringen 32 klæber til henholdsvis legemet 16 og bagvæggen 28, og den 20 indre omkreds af ringen 32 klæber til flangen 20. Anordningen er konstrueret på denne måde for at arrangere legemet 16 i frontpladen 14 nær til patientens legeme og med et kirurgisk dræn indsat gennem åbningen 18 i pladen og bag ved bagvæggen 28 for dræn til posen 26.A drain bag 26, shown only in fragmentary fashion, is attached 15 to the device for collecting waste fluid from the body. The bag 26 comprises a back wall 28 with a circular aperture 30 which is included in the flange 20. The back wall 28 is secured to the front plate 14 with an elastomeric adhesive ring 32. Opposite sides of the ring 32 adhere to the body 16 and the back wall 28, respectively, and the inner 20 circumference of the ring 32 adheres to the flange 20. The device is constructed in this way to arrange the body 16 in the front plate 14 close to the patient's body and with a surgical drain inserted through the opening 18 in the plate and behind the back wall 28 for sinks to the bag 26.
25 Lukkepuden eller pakningen 12 er beliggende mellem frontpladen 14 og patientens hud, der omgiver drænet. Lukkepuden 12 tjener til at optage affaldsvæske, som er stærkt irriterende over for huden og indeholder mikroorganismer fra indvoldene samt giver en ubehagelig lugt. Endvidere tjener lukkepuden 30 12 til at holde anordningen 10 på plads og at gøre anvendel sen mere bekvem for patienten.The closure pad or gasket 12 is located between the front plate 14 and the patient's skin surrounding the drain. The closure pad 12 serves to absorb waste liquid which is highly irritating to the skin and contains microorganisms from the intestine and gives off an unpleasant odor. Furthermore, the closure pad 30 12 serves to hold the device 10 in place and to make the application more convenient for the patient.
Lukkepuden 12 ifølge opfindelsen er særlig tilpasset de ovennævnte funktioner. Som følge af sammensætningen kan puden 12 være støbt i en vilkårlig form, og den vil opretholde sin form 35 og ikke bryde itu. Med henvisning til fig. 1-3 kan lukke- 5 145752 puden 12 ifølge opfindelsen omfatte et ringformet skivelignende legeme 34, der definerer en central cirkulær åbning 36 i puden, og en cirkulær formet kant eller flange 38, der går ud i et med legemet 34 omkring den indre periferi deraf ved 5 den centrale åbning 36 og rager på tværs ud derfra. En overflade 40 af legemet 34, som ligger tæt op mod kanten 38, er i hovedsagen flad og ligger i et plan i det væsentlige vinkelret på aksen af kanten. Overfladen 42 på den modsatte side af legemet 34 rager indad fra den flade overflade 40 og er let 10 afrundet eller kurvet.The closure pad 12 according to the invention is particularly adapted to the above functions. As a result of the composition, the pad 12 may be molded in any shape and will maintain its shape 35 and will not break. Referring to FIG. 1-3, the closure pad 12 of the invention may comprise an annular disc-like body 34 defining a central circular aperture 36 in the pad and a circular edge or flange 38 extending integrally with the body 34 around the inner periphery. thereof at the central opening 36 and projecting transversely therefrom. A surface 40 of the body 34 which is close to the edge 38 is substantially flat and lies in a plane substantially perpendicular to the axis of the edge. The surface 42 on the opposite side of the body 34 projects inwardly from the flat surface 40 and is slightly rounded or curved.
Kanten 38 af lukkepuden 12 har en ydre diameter, som fortrinsvis er tilnærmelsesvis den samme som, men kan være mindre end den indre diameter af frontpladeflangen 20, således at kanten kan sættes ind gennem frontpladeåbningen 18. Legemet 34 af 15 lukkepuden 12 ligger over legemet 16 af frontpladen 14. På denne måde er legemet 34 af lukkepuden 12 anbragt mellem patientens hud i et område der omgiver drænet, og overfladen af frontpladen 14, især overfladen af legemet 16. Kanten 38 af lukkepuden 12 rager gennem frontpladen 14 og er anbragt mellem 20 drænet og frontpladen, især flangen 20 af sidstnævnte. Legemet 34 af lukkepuden 12 er presset imod hud-området omkring drænet til dannelse af en lukning omkring drænet. Kanten 38 hjælper til at danne en lukning eller pakning og beskytter endvidere drænet fra slid og brud forårsaget af kontakt med 25 frontpladen 14, især i området for flangen 20 og forbindelsen mellem flangen og legemet 16.The edge 38 of the closure pad 12 has an outer diameter which is preferably approximately the same as, but may be smaller than, the inner diameter of the faceplate flange 20, so that the edge can be inserted through the faceplate opening 18. The body 34 of the 15 closure pad 12 is above the body 16 of the faceplate 14. In this way, the body 34 of the closure pad 12 is disposed between the patient's skin in an area surrounding the drain, and the surface of the faceplate 14, especially the surface of the body 16. The edge 38 of the closure pad 12 extends through the faceplate 14 and is disposed between 20 the drain and faceplate, especially the flange 20 of the latter. The body 34 of the closure pad 12 is pressed against the skin area around the drain to form a closure around the drain. The edge 38 helps to form a closure or gasket and further protects the drain from wear and tear caused by contact with the front plate 14, especially in the region of the flange 20 and the connection between the flange and the body 16.
Lukkepuden 12 bliver ved anvendelsen fortrinsvis fugtet lidt med vand, og overskud af vand rystes af puden for at gøre denne klæbrig. Puden klæber derefter let til patientens hud og 30 også til frontpladen 14. Lukkepuden 12 hjælper til at holde huden omkring drænet ren og i sanitær tilfredsstillende tilstand med minimal irritation. Disse resultater opnås på grund af den gode vedhængning af lukkepuden således, at der dannes et effektivt lukke i et forholdsvis langt tidsrum, og fordi 35 pudematerialet ikke virker nærende for mikroorganismer. Lukkepuden 12 er blød og eftergivelig, således at anordningen 10 6 145752 bliver forholdsvis komfortabel for patienten. Lukkepuden 12 opløses gradvis af væsken fra drænet, og den udskiftes, når den begynder af blive mindre effektiv. Puden bryder ikke i stykker eller aflejrer partikler i drænposen 26, således som 5 det sker med hidtil kendte puder.The closure pad 12 is preferably slightly moistened with water during use, and excess water is shaken by the pad to make it sticky. The pad then adheres easily to the patient's skin and also to the faceplate 14. The closure pad 12 helps to keep the skin around the drain clean and in sanitary satisfactory condition with minimal irritation. These results are obtained due to the good adhesion of the closure pad so that an effective closure is formed for a relatively long period of time and because the cushion material does not nourish microorganisms. The closure pad 12 is soft and compliant so that the device 10 is relatively comfortable for the patient. The closure pad 12 gradually dissolves from the fluid from the drain and is replaced as it begins to become less effective. The pad does not break or deposit particles in the drain bag 26, as is the case with previously known pads.
Det ved fremgangsmåden ifølge opfindelsen fremstillede materiale er en halvfast gel, som er et reaktionsprodukt af to acrylpolymere med ethylenglyco1. Den ene polymere er en copolymer af acrylamid og Ø-methacryloxyethyltrimethyl-ammonium-10 methylsulfat (i det efterfølgende undertiden omtalt med forkortelsen MTMMS), som indeholder 10-40 vægt-% MTMMS svarende til et molært forhold på 3-12 %, mens resten er acrylamid.The material prepared by the process of the invention is a semi-solid gel which is a reaction product of two acrylic polymers with ethylene glycol. One polymer is a copolymer of acrylamide and β-methacryloxyethyltrimethyl-ammonium-10-methylsulfate (hereinafter sometimes referred to as the abbreviation MTMMS), which contains 10-40% by weight MTMMS corresponding to a molar ratio of 3-12%, while the rest is acrylamide.
Ifølge en foretrukken udførelsesform indeholder den copoly-mere 14-23 vægt-% MTMMS, svarende til et molært forhold på 15 3-6 %.In a preferred embodiment, the copolymer contains 14-23 wt% MTMMS, corresponding to a molar ratio of 15 to 6%.
Foretrukne copolymere omfatter Reten 210 og Reten 220 højmolekylære kationiske vandopløselige polymere (Hercules Incorporated). De polymere har molekylvægte på 5-10 millioner, og de leveres som fint fordelte pulvere med en sigteanalyse 20 på 99 % gennem sigte nr. 40 efter USA sigtestandard. Reten 210 indeholder 14-23 vægt-% MTMMS, svarende til 3-6 mol-% monomer, mens resten er copolymeriseret acrylamid. Den polymere har en opløsningsviskositet på 600-1000 cP (viskositeter bestemt i 1 % vandig opløsning ved 25 °C, Brookfield LVF, 25 30 omdr./min.). Reten 220 indeholder 30-40 vægt-% MTMMS mono mer svarende til 8-12 mol-%, mens resten er copolymeriseret acrylamid. Opløsningsviskositeten er 800-1200 cP.Preferred copolymers include Reten 210 and Reten 220 high molecular weight cationic water-soluble polymers (Hercules Incorporated). The polymers have molecular weights of 5-10 million and are supplied as finely divided powders with a sieve analysis 20 of 99% through sieve No. 40 according to US sieving standard. Reet 210 contains 14-23 wt% MTMMS, corresponding to 3-6 mole% monomer, while the remainder is copolymerized acrylamide. The polymer has a solution viscosity of 600-1000 cP (viscosities determined in 1% aqueous solution at 25 ° C, Brookfield LVF, 25 rpm). Retain 220 contains 30-40% by weight of MTMMS monomers corresponding to 8-12 mol%, while the residue is copolymerized acrylamide. The solution viscosity is 800-1200 cP.
Den anden polymere er polyacrylamid kan indeholde op til 4 vægt-% polymeriseret natriumacrylat, der stammer fra 30 hydrolyse under polymerisationen af acrylamid. Polyacryl- amidet anvendes i en mængde på op til 9 vægtdele pr. vægtdel acrylamid-MTMMS-copolymer. Fortrinsvis anvendes polyacrylamid i et vægtforhold til den copolymere på 4-9:1.The second polymer is polyacrylamide can contain up to 4% by weight of polymerized sodium acrylate resulting from hydrolysis during the polymerization of acrylamide. The polyacrylamide is used in an amount of up to 9 parts by weight per day. part by weight of acrylamide MTMMS copolymer. Preferably, polyacrylamide is used in a weight ratio of the copolymer of 4-9: 1.
7 1457527 145752
Et foretrukket kommercielt tilgængeligt polyacrylamid-produkt er Reten 420, en hovedsagelig ikke-ionisk vandopløselig polymer af acrylamid med et skønnet indhold af copolymeriseret natriumacrylat stammende fra hydrolyse af 2-4 vægt-% og en 5 molekylvægt på 5-10 millioner. Produktet leveres som et pulver, hvoraf 99 % passerer gennem sigte nr. 20 efter USA sigte-standard. Den polymere har en opløsningsviskositet på 300-500 cP (1 % vandig opløsning ved 25 °C, Brookfield LVF, 60 omdr./ min.).A preferred commercially available polyacrylamide product is Reten 420, a substantially nonionic water-soluble polymer of acrylamide with an estimated content of copolymerized sodium acrylate resulting from hydrolysis of 2-4% by weight and a 5 molecular weight of 5-10 million. The product is supplied as a powder, 99% of which passes through screen No. 20 according to the US screen standard. The polymer has a solution viscosity of 300-500 cP (1% aqueous solution at 25 ° C, Brookfield LVF, 60 rpm).
10 Reaktionsblandingen indeholder ethylenglycol i en vægtmængde på 2-5 dele pr del af den tilstedeværende polymere i reaktionsblandingen, dvs. den totale mængde acrylamid-MTMMS-copolymer og polyacrylamid. Det foretrækkes endvidere, at vægtmængden af ethylenglycol er 4-50 dele pr. del acrylamid-MTMMS-copolymer.The reaction mixture contains ethylene glycol in an amount of 2-5 parts per part of the polymer present in the reaction mixture, i.e. the total amount of acrylamide MTMMS copolymer and polyacrylamide. It is further preferred that the weight amount of ethylene glycol is 4-50 parts per kilogram. part acrylamide MTMMS copolymer.
15 Reaktionen af blandingen af polymere og ethylenglycol sker spontant ved stuetemperatur eller ved ca. 22 °C under i det væsentlige vandfrie betingelser. Som illustreret i eksemplerne vil der under sådanne betingelser dannes en halvfast gel i løbet af 30-60 minutter. Den således dannede gel har 20 de ovenfor beskrevne egenskaber, der er hensigtsmæssige for dannelse af lukkepuden ifølge opfindelsen. Materialet kan dannes i en ønsket form ved støbning eller sprøjte-støbning.The reaction of the mixture of polymer and ethylene glycol occurs spontaneously at room temperature or at ca. 22 ° C under substantially anhydrous conditions. As illustrated in the Examples, under such conditions, a semi-solid gel will form over 30-60 minutes. The gel thus formed has the properties described above which are suitable for forming the closure pad according to the invention. The material can be formed in a desired shape by casting or injection molding.
Et materiale dannet ved indføring af både acrylamid-MTMMS-copolymer og polyacrylamid i reaktionsblandingen har en kon-25 sistens og en elasticitet svarende til silicone-gummi. Materialet er tættere end de ovenfor beskrevne hidtil kendte materialer til samme formål, hvorved opnås større alsidighed ved støbning af de ønskede former. Et materiale dannet ved alene at indføre acrylamid-MTMMS-copolymer, dvs. uden poly-30 acrylamid, har en dårligere konsistens og elasticitet og er mere kitagtig. Sidstnævnte materiale opløses også hurtigere.A material formed by introducing both acrylamide-MTMMS copolymer and polyacrylamide into the reaction mixture has a consistency and an elasticity similar to silicone rubber. The material is denser than the previously described materials for the same purpose, thereby achieving greater versatility in molding the desired shapes. A material formed by introducing acrylamide MTMMS copolymer alone, i.e. without poly-acrylamide, has poorer consistency and elasticity and is more putty. The latter material also dissolves faster.
Hastigheden ved geldannelsen kan reguleres ved om ønsket under reaktionen at afkøle blandingen. Et mere stift og mindre ela- 145752 δ stisk materiale kan dannes ved at lede reaktionen under højere temperaturer og tryk, f.eks. i en autoklav ved indirekte opvarmning med lavtryksdamp.The rate of gel formation can be controlled by cooling the mixture if desired during the reaction. A more rigid and less elastic material can be formed by conducting the reaction under higher temperatures and pressures, e.g. in an autoclave by indirect heating with low pressure steam.
Medikamenter, mikrobiocider og lignende kan indføres i reak-5 tionsblandingen.Medicines, microbiocides and the like can be introduced into the reaction mixture.
Opfindelsen skal i det efterfølgende illustreres nærmere ved hjælp af nogle eksempler.The invention will now be further illustrated by means of some examples.
Eksempel 1Example 1
Reten 210 og Reten 420 acrylpolymere i pulverform med den oven-10 for beskrevne sammensætning anvendes til fremstilling af materialet. 24 g Reten 210 og 126 g Reten 420 blandes grundigt.Reten 210 and Reten 420 powdered acrylic polymers having the above described composition are used to prepare the material. 24 g of Reten 210 and 126 g of Reten 420 are thoroughly mixed.
537 g ethylenglycol sættes til denne blanding af polymere ved stuetemperatur, og blandingen omrøres i flere minutter under hovedsagelig vandfrie betingelser, indtil den er lind og ud-15 støbelig. Den flydende blanding hældes i en form eller på en støbeplade, hvor der finder en exoterm reaktion sted. Blandingen bringes til at reagere under almindelige atmosfæriske betingelser, og der sker en geldannelse. Et halvfast eller tyk gel dannes i løbet af ca. 30 minutter. Det dannede mate-20 riale kan steriliseres ved bestråling med cobalt (60), med ethylenoxid eller ved autoklavering. Materialet kan derefter anvendes i form af en pude til dannelse af en lukkepude for en ostomi-anordning.537 g of ethylene glycol are added to this mixture of polymers at room temperature and the mixture is stirred for several minutes under essentially anhydrous conditions until it is softened and moldable. The liquid mixture is poured into a mold or casting plate where an exothermic reaction takes place. The mixture is reacted under ordinary atmospheric conditions and a gelling occurs. A semi-solid or thick gel is formed over approx. 30 minutes. The material formed can be sterilized by irradiation with cobalt (60), with ethylene oxide or by autoclaving. The material can then be used in the form of a pad to form a closure pad for an ostomy device.
Eksempel 2 25 Et materiale fremstilledes som beskrevet i eksempel 1 ud fra Reten 210 og Reten 420. Reten 210 indeholdt 18,4 vægt-% MTMMS og resten copolymeriseret acrylamid. Reten 420 viste sig ved analyse at indeholde 0,32 % natrium i form af natriumacrylat, mens resten var copolymeriseret acrylamid.Example 2 A material was prepared as described in Example 1 from Reten 210 and Reten 420. Reten 210 contained 18.4 wt% MTMMS and the residue copolymerized acrylamide. Retention 420 was found by analysis to contain 0.32% sodium in the form of sodium acrylate, while the residue was copolymerized acrylamide.
30 Materialet anvendtes til prøver for øjenirritation og primær hud-irritation udført på albino-rotter og behandlet ifølge 9 145752The material was used for eye irritation and primary skin irritation tests performed on albino rats and treated according to 9 145752
Draize et al, "Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes", J. Pharm. & Exp. Ther., 82, 377 (1944). Prøven for øjenirritation er også beskrevet i USA patent nr. 3 640 741. Det 5 anvendte bedømmelsessystem for graden af irritation i den respektive prøve var følgende: øjenirritation Hudirritation ekstrem ekstrem kraftig kraftig 10 moderat moderat mild mild minimal svag praktisk taget ingen minimal ingen ingen 15 Irritationen som følge af anvendelsen af materialet havde en værdi på minimal ved hver prøve. 'Draize et al, "Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes", J. Pharm. & Exp. Ther., 82, 377 (1944). The eye irritation test is also disclosed in US Patent No. 3,640,741. The 5 rating system used for the degree of irritation in the respective sample was as follows: eye irritation Skin irritation extremely extreme severe vigorous 10 moderate moderate mild mild mild slight virtually no none none 15 The irritation due to the use of the material was minimal at each sample. '
Eksempel 3Example 3
Reten 210 og Reten 420 anvendt i pulverform og ethylenglycol blandes og omsættes på den i eksempel 1 beskrev-20 ne måde. Materialerne, mængdeforhold og tilnærmet tid, som kræves til at producere en halvfast eller tyk gel, egnet til anvendelse i form af en lukkepude for en'ostomi-anordning, er følgende:The reten 210 and reten 420 used in powder form and ethylene glycol are mixed and reacted in the manner described in Example 1. The materials, proportions and approximate time required to produce a semi-solid or thick gel suitable for use in the form of a closure pad for an ostomy device are as follows:
Ethylen- Gel-tidEthylene Gel Time
Reten 210 Reten 420 glycol minutter 25 6 54 224 60 24 108 269 30 6 54 269 60Reten 210 Reten 420 glycol minutes 25 6 54 224 60 24 108 269 30 6 54 269 60
Claims (2)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DK452177A DK145752C (en) | 1977-10-12 | 1977-10-12 | CUSHION PUSH FOR USE AS A PACKAGING FOR AN OSTOMI DEVICE AND PROCEDURE FOR PRODUCING THE SAME |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DK452177A DK145752C (en) | 1977-10-12 | 1977-10-12 | CUSHION PUSH FOR USE AS A PACKAGING FOR AN OSTOMI DEVICE AND PROCEDURE FOR PRODUCING THE SAME |
| DK452177 | 1977-10-12 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| DK452177A DK452177A (en) | 1979-04-13 |
| DK145752B true DK145752B (en) | 1983-02-21 |
| DK145752C DK145752C (en) | 1983-08-08 |
Family
ID=8134299
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK452177A DK145752C (en) | 1977-10-12 | 1977-10-12 | CUSHION PUSH FOR USE AS A PACKAGING FOR AN OSTOMI DEVICE AND PROCEDURE FOR PRODUCING THE SAME |
Country Status (1)
| Country | Link |
|---|---|
| DK (1) | DK145752C (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| LT3727240T (en) * | 2017-12-22 | 2022-03-10 | Coloplast A/S | Accessory devices of an ostomy system, and related methods for communicating operating state |
-
1977
- 1977-10-12 DK DK452177A patent/DK145752C/en not_active IP Right Cessation
Also Published As
| Publication number | Publication date |
|---|---|
| DK452177A (en) | 1979-04-13 |
| DK145752C (en) | 1983-08-08 |
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| Date | Code | Title | Description |
|---|---|---|---|
| PBP | Patent lapsed |