DK170660B1 - Bærbart apparat til subcutan eller intradermal injektion - Google Patents
Bærbart apparat til subcutan eller intradermal injektion Download PDFInfo
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- DK170660B1 DK170660B1 DK665887A DK665887A DK170660B1 DK 170660 B1 DK170660 B1 DK 170660B1 DK 665887 A DK665887 A DK 665887A DK 665887 A DK665887 A DK 665887A DK 170660 B1 DK170660 B1 DK 170660B1
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- needle
- injection apparatus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/14586—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of a flexible diaphragm
- A61M5/14593—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of a flexible diaphragm the diaphragm being actuated by fluid pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M2005/14204—Pressure infusion, e.g. using pumps with gas-producing electrochemical cell
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
- A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M2005/14264—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body with means for compensating influence from the environment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M2005/14268—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body with a reusable and a disposable component
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/16877—Adjusting flow; Devices for setting a flow rate
- A61M5/16881—Regulating valves
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S128/00—Surgery
- Y10S128/12—Pressure infusion
Description
Opfindelsen angår et bærbart apparat til indtradermal eller subcutan injektion af et biologisk virksomt, flydende stof.
i DK 170660 B1
Der har i nogen tid vist sig et tydeligt behov for 5 en lille, kompakt og bærbar injektionsindretning, som kan bæres på et egnet sted på kroppen og gennem et længere tidsrum afgive en nøjagtig defineret mængde af biologisk virksomme stoffer i kroppen, fortrinsvis subcutant. Der kendes allerede forskellige indretninger af denne art med væsentlige 10 fordele frem for de konventionelle subcutansprøjter. Ved sædvanlig subcutan injektion bringes en såkaldt bolus af et biologisk virksomt stof ind i kroppen, hvor det efterhånden skal absorberes og fordeles i kroppen. Denne fordeling afhænger stærkt af individets fysiologiske omstændigheder og 15 kan derfor ikke længere kontrolleres. Indretninger, som gennem længere tid kontinuerligt afgiver et biologisk virksomt stof har i modsætning hertil den fordel, at kontrol, der er nøje afstemt med kroppens behov, er mulig. Det er endog muligt at lade faser med afgivelse af stoffet veksle 20 med faser, hvor intet stof afgives. Specielt med stærkt virksomme stoffer som f.eks. insulin, interferon og lignende stoffer er en sådan fysiologisk tilpasset afgivelse af stoffet fordelagtig.
Kendte apparater af denne art har sædvanligvis en 25 beholder for stoffet og en med beholderen forbundet injektionsnål. Ved hjælp af en pumpeindretning afgives beholderindholdet i kroppen fordelt over et forudbestemt tidsrum.
Et eksempel på en sådan indretning fremgår af DE-A1 nr. 3.121.888. Apparatet har en forrådsbeholder i form af en 30 slange, som ved hjælp af en af et urværk drevet klemvalse tømmes gennem en ved enden af slangen tilsluttet injektionsnål. Injektionsnålen indstikkes i hudvævet i nogen afstand fra apparatet. Apparatet kan ligesom et armbåndsur bæres om håndleddet. En anden løsning er beskrevet i US-patentskrift 35 nr. 4.552.561. Det deri beskrevne apparat kan fastklæbes på huden og bærer injektionsnålen på sin underside, således at 2 DK 170660 B1 indstikningsstedet dækkes under anvendelsen af apparatet.
Også ved dette apparat må nålen indstikkes i hudvævet. Både ved de sædvanligs subcutane bolusinjektioner og ved de nævnte nyere subcutane injektionsindretninger er især indstikningen 5 af injektionsnålen problematisk. Medicinsk ukyndige har i » reglen ikke tilstrækkelig øvelse til at placere en sådan nål rigtigt og har hyppigt en helt igennem berettiget tilbageholdenhed på grund af de forventede smerter.
Det er formålet med opfindelsen at tilvejebringe en 10 bærbar injektionsindretning af den nævnte art, hvori de med de kendte apparater forbundne ulemper ikke optræder, og en indretning eller et apparat som især uden videre kan anvendes af medicinsk ukyndige personer.
Dette er ifølge opfindelsen opnået ved hjælp af et 15 apparat af den omhandlede art, der er karakteristisk ved en nåledrivindretning til indskydning af injektionsnålen i patientens hud.
Apparatet kan yderligere være forsynet med en strømningskontrolindretning, ved hjælp af hvilken afgivelsen af 20 stoffet enten kan holdes konstant eller udføres i overensstemmelse med et bestemt profil.
I en videre udviklet udførelsesform for apparatet ifølge opfindelsen består det af to dele, af hvilke den ene del med de mest værdifulde elementer kan benyttes flere 25 gange, og den anden del som forbrugsmateriale kan bortkastes efter at være benyttet en enkelt gang.
Som beholder for stoffet henholdsvis det opløste biologisk virksomme stof kan f.eks. simpelthen anvendes en del af apparathuset, idet et kammer er fraskilt ved hjælp 30 af en egnet membran af elastomerer, metaller og lignende materialer i ét eller flere lag. En anden mulighed for en forrådsbeholder er en lukket beholder igen af elastomerer, metaller og lignende materialer f.eks. i form af en bælg. I endnu en udførelsesform kan forrådsbeholderen være en klem-35 slange, således som det f.eks. er angivet i den indledningsvis omtalte patentbeskrivelse. Endnu en mulighed er en stem- 3 DK 170660 B1 pelsprøjte, hvis cylinder tjener som forrådsbeholder. Endelig kan et sugedygtigt materiale i lighed med en svamp også tjene til optagelse af det biologisk virksomme stof. Der kan findes flere indbyrdes adskilte forrådsbeholdere eller 5 kamre, f.eks. hvor der er tale om to stoffer, eller hvor der benyttes et stoflyofilisat og et rekonstitutionsopløs-ningsmiddel. Til drift af pumpeindretningen til tømning af beholderen kan der anvendes forskellige energikilder. Pumpen kan f.eks. være gasdrevet, idet det til tømning af beholderen 10 nødvendige tryk kan opnås ved elektrolyse-, fotolyse eller kemiske reaktioner og endelig også ved hjælp af drivdampe som f.eks. freon osv. En anden mulighed er at opnå det nødvendige tryk ved hjælp af simpel osmose eller elektroosmose. Desuden er det naturligvis også muligt at anvende mekaniske 15 drivorganer, f.eks. fjedre, bimetaller, legeringer med hukommelse eller urværker. Endelig kan der også være tale om elektriske eller magnetiske drev i form af kendte elektropum-per, membranpumper, piezoelektriske pumper, elektriske urværker eller magneter.
20 Til fastgørelse af apparatet på et egnet sted af patientens krop egner sig især et klæbelag på apparatets anlægsflade, hvilket lag eventuelt i form af et plaster strækker sig ud forbi apparatet. Et alternativ hertil er f.eks. et fastgørelsesbånd såsom det i det foran nævnte 25 tyske offentliggørelsesskrift viste armbånd.
Som drivorgan for nålen anvendes fortrinsvis en metalfjeder. Ved konstant strømning indstilles den konstante frigørelse af det biologisk virksomme stof f.eks. ved hjælp af kapillarer, fritter eller membraner. Endvidere kan strøm 30 ningen indstilles ved tilpasning af viskositeten af det flydende stof.
Kontrollen af den afgivne mængde af stoffer kan ligeledes tilvejebringes på forskellige måder. Der kan f.eks. mellem forrådsbeholderen og nålen være anbragt en slangepum-35 pe i form af en slange, hvis diameter efter behov forøges eller reduceres. En anden mulighed er at udnytte en trykre- 4 DK 170660 B1 duktionsventil af kendt art. Endnu en mulighed består i valg af et bestemt område for udvidelsen af drivfjederen eller at benytte særlige tallerkenfjedre, hvor kraften er konstant over en vejstrækning inden for forud fastsatte 5 grænser. En dyrere strømningskontrol er også mulig ved til-bagekobling ved hjælp af sensorer. Endelig kan strømningskontrol også ske ved, at der benyttes et specielt programmeret pumpeværk til at drive beholderudtømningen.
Som injektionsnåle anvendes så tynde kapillarer som 10 muligt, dvs. med en diameter, der fortrinsvis er mindre end 0,5 mm, idet smerten ved indstikning tiltager med nåletykkelsen. Indstikningsdybden og nålens slibning indvirker også på smertefremkaldelsen. Derfor overskrides helst ikke en indstikningsdybde på 5000 Atm. Desuden er nålen skråtslebet, 15 f.eks. lancetslebet.
Selv om smerte undgås på grund af nålediameteren og indstikningsdybden, kan det biologisk virksomme stof selv forårsage smerte eller irritation. Dette kan modvirkes ved hjælp af et lokalanæstetikum i det biologisk virksomme stof.
20 I det følgende beskrives nogle udførelsesformer for apparatet ifølge opfindelsen under henvisning til tegningen, hvor fig. 1 viser et tværsnit gennem et injektionsapparat ifølge opfindelsen i snit efter linien A-A i fig. 2, 25 fig. 2 det i fig. 1 viste apparat set ovenfra, fig. 3 et tværsnit gennem en anden udførelsesform for apparatet ifølge opfindelsen vist i snit efter linien A-A i fig. 4, 30 fig. 4 apparatet i fig. 3 set ovenfra og delvis i snit efter linien B-B i fig. 3, v fig. 5 et tværsnit gennem endnu en udførelsesform for apparatet ifølge opfindelsen set i snit efter linien A-A i fig. 6, 35 fig. 6 et snit efter linien B-B i fig. 5, fig. 7 et tværsnit gennem yderligere en udførelsesform 5 DK 170660 B1 for apparatet ifølge opfindelsen, fig. 8 et snit efter linien A-A i fig. 7, og fig. 9 et snit i et plan vinkelret på aksen gennem endnu en udførelsesform for apparatet ifølge opfindelsen.
5 Det i fig. 1 og 2 viste apparat består af et todelt, fladt cylindrisk hus med en underdel 1 og en overdel 2. De to husdele er fast forbundet med hinanden f.eks. ved hjælp af et ikke vist gevind. Ved hjælp af ringformede udsparinger i de mod hinanden liggende flader på de to dele er der dannet 10 et ringformet kammer 3. Det ringformede kammer opdeles ved hjælp af en membran i to indbyrdes adskilte rum. De to rum er forbundet med ydersiderne gennem indfyldningsåbninger 5, 6, der normalt er lukkede med propper.
I centrum af det skiveformede hus findes en injek-15 tionsnål 7 med en til indskydning af nålen egnet drivindretning. Injektionsnålen består af et stålkapillarrør med en diameter på 200 μτα. Alternativt kunne der eventuelt anvendes et glaskapillarrør. Injektionsnålen 7 holdes af en nåleholder 8, der har en nederste cylindrisk del og en øverste flad, 20 skiveformet del. Den cylindriske del er anbragt aksialt forskydelig i en tilsvarende boring 9 i husunderdelen l. Den har en på tværs af sin akse forløbende boring 10, som står i forbindelse med det indre af den hule injektionsnål 7. Den cylindriske yderside er forsynet med tre omløbende 25 noter, hvori der er indsat tætnende O-ringe. Endvidere er der i højde med boringen 10 også en flad, rundtgående not.
Boringen 9 har ved sin nederste del en formindsket diameter, der blot tillader gennemføring af nålen.
30 Den øverste, skiveformede del af nåleholderen 8 er anbragt forskydelig i en tilsvarende anden koncentrisk boring 11 i husoverdelen 2. På omtrent en tredjedel af husoverdelens tykkelse er diameteren af boringen 11 formindsket til omtrent det halve. Herved er der dannet et anslag, og mellem dette 35 anslag og overdelen af nåleholderen 8 er anbragt en drivfjeder 12, der tjener til at indskyde nålen i patientens hud.
6 DK 170660 B1 Nåleholderen 8 er endvidere forsynet med fjedrende holdefingre 13, der strækker sig opad fra dens overflade. Disse holdefingre er forsynede med en klinkelignende ansats, der griber ind over kanten af et udvidet parti af boringen 5 11. Når holdefingrene 13 er i indgreb, befinder nåleholderen 8 med nålen 7 sig i sin øverste stilling, i hvilken fjederen 12 er spændt, og nålen ikke rager ud fra husets underside.
Mellem holdefingeren findes en sikringskappe 14, som forhindrer, at de fjedrende holdefingre 13 utilsigtet 10 kan trykkes sammen, og nålen derved blive udløst. På den anden side har kappen en boring, hvis diameter passer således til egnede skråflader på holdefingrene, at disse ved påtrykning af kappen sammenpresses, og holdemekanismen derved udløses.
15 I husunderdelen er udformet en forbindelsesboring 15 mellem det underste rum i kammeret 3 og boringen 9. Denne boring er på en del af sin længde udvidet og optager et drøvlelegeme, der f.eks. kan bestå af en teflonfritte. Boringen 15 er ført således, at den udmunder i boringen 9 i en 20 højde, der svarer til boringen 10 i nåleholderen, når denne befinder sig i sin nederste stilling. I den øverste endestilling er udmundingen af boringen i boringen 9 lukket af den cylindriske del af nåleholderen 8 og de to nederste O-ringe.
Apparatet har på sin underside et klæbelag 16. Desuden 25 er apparatet indesluttet i et tilsvarende udformet fastgørelsesplaster 17. Klæbelaget 16 og plasterets klæbelag er før brug dækket af en beskyttelsesfolie 18. Klæbelaget 16 på undersiden og klæbelaget på plasteret kan indeholde yderligere virksomme stoffer, f.eks. et lokalanæstetikum.
30 Ved fremstillingen bliver det nederste rum af kammeret 3 efter apparatets sammenbygning fyldt med et ønsket biologisk virksomt stof gennem indfyldningsåbningen 5, som derefter lukkes. Ligeledes fyldes det øverste rum af kammeret 3 med et drivmiddel gennem indfyldningsåbningen 6. Disse på-35 fyldninger er i de fleste tilfælde arbejdstrin under fremstillingen og foretages så ikke af anvenderen af apparatet.
7 DK 170660 B1
Hvor der er tale om visse biologisk virksomme stoffer kan det imidlertid være hensigtsmæssigt at foretage påfyldningen kort før anvendelsen. Apparatet er herefter klar til anvendelse.
5 Ved anvendelsen er funktionsmåden som følger:
Brugeren trækker beskyttelsesfolien 18 af og klæber apparatet fast til et passende sted på kroppen ved hjælp af fastgørelsesplasteret 17 og klæbefolien 16. Derefter fjerner han sikringskappen 14, vender den om og trykker den mod 10 fastgørelsesfingrenes 13 skråflader. Herved sammenpresses fingrene og frigiver nåledrivindretningen. Fjederen 12 afspændes og trykker nåleholderen 8 med nålen 7 den fastsatte strækning nedad gennem klæbefolien og ind i brugerens hud. Nålen skal trænge mindst ca. 50 μιη og maksimalt ca. 5000 μιη 15 ind i huden. Som følge af den ringe indtrængningsdybde og nålens lille diameter og stejle tilslibning er indstikningen smertefri eller kun meget lidt smertefrembringende.
Ved forskydningen af nåleholderen bringes tværboringen 10 samtidig i højde med mundingen af forbindelsesboringen 15, 20 således at forbindelsesboringen nu står i forbindelse med nålen 7. Strømningen af det virksomme stof gennem nålen er frigivet og bestemmes dels af trykket fra drivmidlet i det øverste rum i kammeret 3 og dels af drøvlevirkningen i drøv-lelegemet 15. Ved passende valg af disse faktorer kan stør-25 reisen af strømningen af stoffet og dermed varigheden af injektionen bestemmes.
Det i fig. 3 og 4 viste apparat er med hensyn til indskydningsindretningen for nålen opbygget på samme måde som i den foran beskrevne udførelsesform. Til kompensation 30 for tryksvingninger i drivmidlet er der i denne udførelsesform yderligere anvendt en trykreduktionsventil. Trykreduktionsventilen er anbragt i et segment af det cirkelformede hus. Tilsvarende strækker kammeret 3 sig kun over en del af omkredsen.
35 Reduktionsventilen har et selvstændigt hus, der er indsat i en tilsvarende udsparing i apparatets hus. Ventil- i 8 DK 170660 B1 husets indre er som kendt fra trykreduktionsventiler opdelt i et højtrykskaminer 21 og et lavtrykskammer 22 ved hjælp af en membran 20. I forbindelsesboringen mellem højtrykskammeret 21 og lavtrykskammeret 22 er anbragt et.stempel 23, der er 5 fastgjort i centrum af membranen 20 og ved aksial forskydning kan lukke forbindelsesåbningen. På den anden side af membra- 4 nen er en fjeder 24 anbragt mellem stemplet 23 og et indstilleligt modleje 25. Denne fjeder bestemmer i alt væsentligt det tryk, som hersker i lavtrykskammeret. Højtrykskammeret 10 21 er gennem en forbindelsesboring 26 forbundet med det nederste rum af kammeret 3, dvs. beholderen for det biologisk virksomme stof. Lavtrykskammeret er gennem en boring 27 forbundet med den centrale boring 9 og udmunder ligesom i den foran beskrevne udførelsesform i højde med tværboringen 10, 15 når nåleholderen befinder sig i sin nederste endestilling.
Trykreduktionsventilen muliggør opretholdelse af en i vid udstrækning konstant afgivningshastighed af stoffet, uafhængigt af tryksvingninger på højtrykssiden. Sådanne tryksvingninger kan optræde som følge af ændringer i drivmid-20 lets damptryk på grund af temperatursvingninger.
Ligesom i den foran beskrevne udførelsesform forsynes apparatet med klæbelag, fastgørelsesplaster og beskyttelsesfolie, og apparatets funktionsmåde adskiller sig under anvendelsen praktisk taget ikke fra den foran beskrevne.
25 I det i fig. 5 og 6 viste apparat er anvendt en alter nativ indretning til transport af det biologisk virksomme stof og en anden form for beholder eller reservoir. Som reservoir benyttes to poser, blærer eller bælge 28, der i den ene side har en åbning, hvormed de er fastgjort til en 30 holder 29, som også har indfyldningsåbningen 30 og forbindelsesboringen 31 til den centrale boring 9. De to holdere 29 er fast forbundet med den centrale cylindriske del af husets underdel 1. Omkring denne faste del er anbragt et drejelegeme 32, som har to indadragende lister 33, som hver ligger an * 35 mod en af de reservoirdannende poser 28.
Mellem drejelegemet og ydervæggen af husets overdel 9 DK 170660 B1 2 findes et rum, hvori en spiralfjeder 34 er anbragt. Denne spiralfjeder er med sin ene ende fastgjort i husvæggen og med sin anden ende i drejelegemet. Når den spændte spiralfjeder afspændes, bevirker den drejning af drejelegemet, som 5 med listerne 33 sammentrykker posen 28 og på denne måde udtømmer det i posen værende stof gennem forbindelsesåbningen 31. Fortrinsvis benyttes kun en brøkdel af fjederens afspændingsbevægelse til uddrivningen.
Ved at udnytte en del af det udnyttelige vindingsan-10 tal i spiralfjederen til drejebevægelse opnås en styrevirkning. På denne måde opnås altså transporten af det biologisk virksomme stof og styringen henholdsvis kontrollen af strømningen samtidig ved hjælp af drivfjederen. I øvrigt svarer funktionen af denne udførelsesform også til funktionen af 15 den i fig. 1 og 2 viste udførelsesform.
Det i fig. 7 og 8 viste apparat har til forskel fra de hidtil beskrevne udførelsesformer to forrådsbeholdere eller kamre 35, 36 og to separate, med nåle 37, 38 forsynede nåleholdere 39, 40, der drives af en fælles betjeningsmeka-20 nisme 41. Denne udførelsesform egner sig til det tilfælde, hvor to virksomme stoffer skal injiceres samtidig og adskilt.
Alternativt til den vist version kan der i stedet for de to nåleholdere med to nåle også anvendes en enkelt nåleholder med to nåle. Hertil vil der kræves et dyrere 25 tætningssystem.
Den i fig. 9 i snit viste udførelsesform har en elektrisk drevet indretning til transport af det biologisk virksomme stof. På grund af de forholdsvis kostbare elektriske elementer i denne udførelsesform er apparatet opdelt i en 30 bortkastningsdel 42 og i en genanvendelig del 43. De to dele er forbundet med hinanden ved hjælp af fjedrende klemmer 56, som griber ind i passende udsparinger.
Bortkastningsdelen 42 indeholder også her en forrådsbeholder 55 med en ved hjælp af en skillevæg 44 lukket 35 indfyldningsåbning. Gennem systemet kan reservoiret eventuelt først fyldes kort før brugen. Desuden indeholder bortkast- DK 170660 B1 9 10 ningsdelen en pumpeindretning 45 med en ansugningsventil 46, der står i forbindelse med forrådsbeholderen, en udstødsventil 49, der kontrollerer tilførselsledningen 47 til injek- tionsnålen 48, og en mellem de to ventiler anbragt og med 5 begge forbundet simpel pumpe 50. Pumpeindretningen 45 fungerer på følgende måde: v Når stemplet i pumpen 50 trykkes tilbage fra den viste stilling, udsuges et bestemt volumen fra forrådsbeholderen gennem ansugningsventilen 46. Under denne fase er ud-10 stødsventilen 49 lukket. Når stemplet derefter atter bevæges fremad, lukker ansugningsventilen 46 og udstødsventilen 49 åbner, således at det indsugede volumen tilføres til inj ektionsnålen.
Injektionsnålen med nåleholder og indstikningsmekanis-15 me (ikke vist her) hører ligeledes til bortkastningsdelen.
Den genanvendelige, mere værdifulde del 43 indeholder den elektriske drivanordning for pumpeindretningen. Denne består af en elektromagnet 51, der fremkalder tilbagetrækningen af stemplet i pumpen 50, medens fremadbevægelsen 20 fremkaldes af en tilbageføringsfjeder 52. Elektromagneten 51 styres ved hjælp af en styreelektronik 53. Elektromagneten 51 og styreelektronikken 53 strømfødes fra et batteri 54.
Som alternativ til en stempelpumpe kan der også anvendes en slangepumpe med foranderligt slangetværsnit.
25 En elektrisk drevet pumpe er også særlig velegnet til kombination med elektronisk styring af den udleverede mængde. Udleveringsprofilet kan f.eks. være forprogrammeret og oplagret passende. Kontrollen af udledveringsraten kan ske ved hjælp af egnede følere.
30 I de viste udførelsesformer er nåledrivindretningen til inddrivning af nålen kombineret med hanens funktion.
Det er uden videre muligt at adskille de to funktioner, f.eks. således at nålen kun først indskydes, og hanen derefter åbnes særskilt. Der kan også tænkes andre indstiknings-35 bevægelser i stedet for den simple indskydning vinkelret på hudoverfladen. F.eks. kan den vinkelrette indstikningsbevæ- 11 DK 170660 B1 gelse sammenkobles med en drejebevægelse af nålen, eller nålen kan indskydes skråt i forhold til hudoverfladen.
Claims (14)
1. Bærbart apparat til subcutan eller intradermal injektion af et flydende, biologisk virksomt stof, omfattende en forrådsbeholder (3) for det virksomme stof, en injek- 5 tionsnål (7), der kan bringes i forbindelse med beholderen, en pumpeindretning (4, 32, 34, 50) til tømning af beholderen gennem injektionsnålen og fastgørelsesorganer (16, 17) til fastgørelse af apparatet til et egnet sted på patientens krop, kendetegnet ved en nåledrivindretning (12, 10 13) til indskydning af injektionsnålen i patientens hud.
2. Injektionsapparat ifølge krav 1, kendetegnet ved, en strømningskontrolindretning (20-25).
3. Injektionsapparat ifølge krav 1, kendetegnet ved, at de består af to dele (42, 43), af hvilke 15 dele den ene kan anvendes flere gange, medens den anden del kan bortkastes efter brug.
4. Injektionsapparat ifølge krav 1, kendetegnet ved, at det har flere forrådsbeholdere.
5. Injektionsapparat ifølge krav 1, kendete g-20 net ved, at pumpeindretningen består af et fra forrådsbeholderen ved hjælp af en elastisk membran adskilt kammer, der indeholder et middel til frembringelse af et tryk.
6. Injektionsapparat ifølge krav 1, kendetegnet ved, at pumpeindretningen indbefatter en mekanisk, 25 elektrisk eller magnetisk drivanordning.
7. Injektionsapparat ifølge krav l, kendetegnet ved, at fastgørelsesmidlet består af et klæbelag.
8. Injektionsapparat ifølge krav 7, kendetegnet ved, at der benyttes et klæbelag, som indeholder et 30 lokalanæstetikum.
9. Injektionsapparat ifølge krav 1, kendetegnet ved, at nålen har en diameter, der er mindre end 0,5 mm.
10. Injektionsapparat ifølge krav 1, kendete g- *' 35 net ved, at nåledrivindretningen er kombineret med en hane, der kontrollerer forbindelsen mellem forrådsbeholderen 13 DK 170660 B1 og injektionsnålen.
11. Injektionsapparat ifølge krav 1, kendetegnet ved, at det har en elektronisk styre indretning til styring af pumpeindretningen, hvilken styreindretning er 5 forsynet med et datalager for et forprogr ammer et udleveringsprofil.
12. Injektionsapparat ifølger krav 1, kendetegnet ved, at nåledrivindretningen er indrettet til at arbejde med en indstikningsdybde på fra 0,5 til 5 mm.
12 DK 170660 B1 Patentkrav.
13. Injektionsapparat ifølge krav 1, kendeteg ne t ved, at der i forrådsbeholderen er tilvejebragt en med et septum lukket åbning, gennem hvilken beholderen kan fyldes kort før brug.
14. Injektionsapparat ifølge krav 1, kendete g-15 net ved, at det er kombineret med følere til styring eller regulering af udleveringsraten.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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CH502186 | 1986-12-18 | ||
CH502186 | 1986-12-18 |
Publications (3)
Publication Number | Publication Date |
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DK665887D0 DK665887D0 (da) | 1987-12-17 |
DK665887A DK665887A (da) | 1988-06-19 |
DK170660B1 true DK170660B1 (da) | 1995-11-27 |
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DK665887A DK170660B1 (da) | 1986-12-18 | 1987-12-17 | Bærbart apparat til subcutan eller intradermal injektion |
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US (1) | US4886499A (da) |
EP (1) | EP0272530B1 (da) |
JP (1) | JP2648314B2 (da) |
KR (1) | KR960000845B1 (da) |
AT (1) | ATE68358T1 (da) |
AU (1) | AU620536B2 (da) |
CA (1) | CA1283827C (da) |
DE (1) | DE3773867D1 (da) |
DK (1) | DK170660B1 (da) |
HK (1) | HK27494A (da) |
IE (1) | IE60868B1 (da) |
IL (1) | IL84811A (da) |
NZ (1) | NZ222839A (da) |
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- 1987-12-04 US US07/129,018 patent/US4886499A/en not_active Expired - Lifetime
- 1987-12-07 EP EP87118076A patent/EP0272530B1/de not_active Expired - Lifetime
- 1987-12-07 DE DE8787118076T patent/DE3773867D1/de not_active Expired - Lifetime
- 1987-12-07 AT AT87118076T patent/ATE68358T1/de not_active IP Right Cessation
- 1987-12-08 NZ NZ222839A patent/NZ222839A/en unknown
- 1987-12-11 ZA ZA879351A patent/ZA879351B/xx unknown
- 1987-12-14 IL IL84811A patent/IL84811A/xx not_active IP Right Cessation
- 1987-12-15 PH PH36231A patent/PH26445A/en unknown
- 1987-12-15 KR KR1019870014351A patent/KR960000845B1/ko not_active IP Right Cessation
- 1987-12-17 JP JP62320045A patent/JP2648314B2/ja not_active Expired - Lifetime
- 1987-12-17 AU AU82663/87A patent/AU620536B2/en not_active Expired
- 1987-12-17 DK DK665887A patent/DK170660B1/da not_active IP Right Cessation
- 1987-12-17 IE IE343087A patent/IE60868B1/en not_active IP Right Cessation
-
1994
- 1994-03-24 HK HK274/94A patent/HK27494A/xx not_active IP Right Cessation
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KR960000845B1 (ko) | 1996-01-13 |
IL84811A (en) | 1993-02-21 |
DK665887A (da) | 1988-06-19 |
KR880007095A (ko) | 1988-08-26 |
PH26445A (en) | 1992-07-15 |
DK665887D0 (da) | 1987-12-17 |
US4886499A (en) | 1989-12-12 |
JP2648314B2 (ja) | 1997-08-27 |
ZA879351B (en) | 1988-06-20 |
EP0272530A2 (de) | 1988-06-29 |
HK27494A (en) | 1994-03-31 |
DE3773867D1 (de) | 1991-11-21 |
AU620536B2 (en) | 1992-02-20 |
ATE68358T1 (de) | 1991-11-15 |
EP0272530A3 (en) | 1988-08-31 |
IE873430L (en) | 1988-06-18 |
JPS63164963A (ja) | 1988-07-08 |
EP0272530B1 (de) | 1991-10-16 |
AU8266387A (en) | 1988-06-23 |
IE60868B1 (en) | 1994-08-24 |
CA1283827C (en) | 1991-05-07 |
NZ222839A (en) | 1991-03-26 |
IL84811A0 (en) | 1988-06-30 |
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B1 | Patent granted (law 1993) | ||
PUP | Patent expired |