DK171855B1

DK171855B1 - Disposable syringe

Info

Publication number: DK171855B1
Application number: DK242989A
Authority: DK
Inventors: Terence R Ellard; Michael J Free
Original assignee: Becton Dickinson Co
Priority date: 1987-09-18
Filing date: 1989-05-18
Publication date: 1997-07-14
Also published as: HK1007968A1; DK242989D0; ZA886882B; DK242989A; BR8804810A; CN1033009A; ATE104557T1

Description

DK 171855 B1DK 171855 B1

Opfindelsen angår en engangssprøjte af den i krav l's og 2's indledning anførte art.The invention relates to a disposable syringe of the kind set forth in claims 1 and 2.

Almindelige engangssprøjter er, selv om de er tiltænkt for engangsbrug, konstrueret på en sådan måde, at de kan genan-5 vendes. Korrekt engangsbrug, destruktion og bortskaffelse af disse indretninger kræver fuldstændig indvilligelse fra brugerens og generelt et kontrolleret miljø.Ordinary disposable syringes, although intended for single use, are constructed in such a way that they can be reused. Proper disposable use, destruction and disposal of these devices requires complete consent of the user and generally a controlled environment.

I et miljø uden passende kontrol, dvs. uden for et hospital eller en klinik, er engangssprøjterne kommet i hænderne på 10 folk, som har benyttet dem ukorrekt, f.eks. benyttet dem til indsprøjtning af illegale medikamenter eller indsprøjtning i to eller flere personer uden tilstrækkeligt sterilisation mellem brugen.In an environment without appropriate control, ie. outside a hospital or clinic, the disposable syringes have come into the hands of 10 people who have used them incorrectly, e.g. used them for injecting illicit drugs or injecting two or more people without adequate sterilization between uses.

Ud over spredningen af brugte engangssprøjter fra legitime 15 kilder for indgivelse af illegale og farlige medikamenter bliver sprøjterne, når de ikke er korrekt steriliseret, en bærer for overførsel af sygdomme, herunder HIV virus (AIDS) og hepatitis B.In addition to the proliferation of used disposable syringes from legitimate sources of illicit and dangerous drugs, the syringes, when not properly sterilized, become a carrier for the transmission of diseases including HIV virus (AIDS) and hepatitis B.

En af de foreslåede metoder til forhindring af genanvendelse 20 af engangssprøjter er at emballere medikamentet i en selvødelæggende sammenklappelig beholder, som indeholder en enkelt dosis, og som dernæst presses og klappes sammen for indgivelse af medikamentet.One of the proposed methods for preventing the reuse of disposable syringes is to package the drug in a self-destructible collapsible container containing a single dose, which is then compressed and collapsed for administration of the drug.

Imidlertid er ikke alle medikamenter velegnede til at blive 25 benyttet i på forhånd fyldte enkeltdosissystemer. Visse medikamenter leveres mest økonomisk og ønskværdigt i beholdere indeholdende flere doser. Disse kan da indgives ved hjælp af en engangssprøjte eller en steriliserbar sprøjte til flergangsbrug .However, not all drugs are suitable for use in pre-filled single dose systems. Certain drugs are delivered most economically and desirably in containers containing multiple doses. These can then be administered by a disposable syringe or a sterilizable syringe for multiple use.

Kendte indretninger, som vedrører problemet med genanvendelige sprøjter i en eller anden form indbefatter US-A- 30 DK 171855 B1 2 2.618.263, som viser et afmålt medikament i en ampul nær en kanyles indre ende. Når ampullen påføres et tryk, trænger kanylen ind i ampullen, og medikamentet udledes. Hele indretningen bortskaffes herefter.Known devices which address the problem of reusable syringes in one form or another include US-A-DK DK 2,618,263 which discloses a metered drug in an ampoule near the inner end of a needle. When a vial is applied, the needle penetrates the vial and the drug is discharged. The entire device is then disposed of.

5 US-A-4.013.073 viser en sammenklappelig engangssprøjte, hvor det indre af den sammenklappelige vægge er konstrueret således, at når væggene sammenpresses for udtømning af medikamentet, sammenlåses de og gør det derved umuligt at genanvende indretningen.5 US-A-4,013,073 discloses a disposable collapsible syringe, wherein the interior of the collapsible walls is constructed such that when the walls are compressed to discharge the drug, they are interlocked making it impossible to reuse the device.

10 US-A-4.022.206 viser en fremgangsmåde og et apparat til opbevaring og udlevering af en lyofiliseret vaccine i et foremballeret enkeltdosissystem, men viser ingen foranstaltninger til at gøre enheden ikke-genanvendelig.US-A-4,022,206 discloses a method and apparatus for storing and dispensing a lyophilized vaccine in a pre-packaged single dose system, but shows no measures to render the device non-reusable.

US-A-4.391.273 viser en stiv sprøjte med en stift, som er 15 fastgjort til stemplet, og som gennembryder cylinderens bundvæg, når indsprøjtningen er blevet tilendebragt. Endvidere viser dette patent en kniv, som tillader bevægelse af cylinderen i fremadgående retning, men gennemskærer cylinderens sidevæg, hvis der gøres forsøg på at føre stemplet tilbage 20 eller genanvende sprøjten.US-A-4,391,273 discloses a rigid syringe with a pin attached to the plunger and which pierces the bottom wall of the cylinder when the injection has been completed. Furthermore, this patent discloses a knife which permits forward movement of the cylinder but cuts through the side wall of the cylinder if attempts are made to retract the plunger 20 or reuse the syringe.

US-A-4.548.601 viser en færdigpakket farmaceutisk kombination indbefattende en indre og en ydre fleksibel kappe, således at den indre kappe vil forblive sammenklappet på grund af atmosfæretrykket, når indsprøjtningen er tilendebragt.US-A-4,548,601 discloses a prepackaged pharmaceutical combination including an inner and an outer flexible sheath such that the inner sheath will remain collapsed due to atmospheric pressure when the injection is completed.

25 DE-A1-3 107 414 beskriver en engangssprøjte med en cylinder og en stempelenhed. Stempelenheden bærer en hermed ud i ét tildannet skive, som er indrettet til at komme i indgreb med en skulder på cylinderen og dermed frigøres fra stempelenheden. Sprøjten har ingen foranstaltninger, som forhindrer, at 30 den kan genanvendes.DE-A1-3 107 414 discloses a disposable syringe with a cylinder and a plunger assembly. The piston unit carries one hereby into one formed disc which is arranged to engage a shoulder on the cylinder and thus is released from the piston unit. The syringe has no measures to prevent it from being recycled.

Formålet med opfindelsen er på enkel og billig måde at udfor- DK 171855 B1 3 me styreindretningen i en sprøjte af den indledningsvis nævnte art, således at den kun vil tillade en enkelt bagudgående bevægelse til fyldning af sprøjten og en enkelt fremadgående bevægelse til indgivelse af medikamentet, men herefter vil 5 fastholde stempelenheden til forhindring af yderligere brug.The object of the invention is, in a simple and inexpensive way, to configure the control device in a syringe of the type mentioned in the introduction, so that it will only allow a single backward movement for filling the syringe and a single forward movement for administration of the drug. , but then 5 will retain the plunger assembly to prevent further use.

Ifølge et første aspekt ved opfindelsen opnås nævnte formål ved at indrette den indledningsvis nævnte engangssprøjte med de i krav 1 anførte kendetegnende træk.According to a first aspect of the invention, said object is achieved by aligning the disposable syringe initially mentioned with the characteristic features of claim 1.

Ifølge et andet aspekt ved opfindelsen opnås formålet ved en 10 engangssprøjte med de i krav 2 anførte kendetegnende træk.According to another aspect of the invention, the object is achieved by a disposable syringe having the characteristic features of claim 2.

Opfindelsen forklares nærmere nedenfor under henvisning til tegningen, hvor fig. 1 viser en typisk sprøjte, som kunne gøre brug af foreliggende opfindelse, 15 fig. 2 isometrisk en del af en sprøjte ifølge opfindelsen med et rendeformet element anbragt på plads i cylinderens indre, fig. 3 set fra siden det rendeformede element anbragt inden i sprøjten, fig. 4 det rendeformede element i fig. 3 set fra siden og 20 uden for sprøjten, fig. 5 det i fig. 3 viste rendeformede element set nedefra, fig. 6 isometrisk det i fig. 3-5 viste rendeformede element i driftsstillingen, fig. 7 et snit efter linien 3-3 i fig. 1, idet det rendefor-25 mede elements stilling inden brug af sprøjten er vist, fig. 8 sprøjten i fig. 7 med målerøret fyldt med medicin, DK 171855 B1 4 fig. 9 sprøjten i fig. 7 efter indgivelsen af medicinen og med stemplet fastlåst op mod målerørets ende, fig. 10 en anden indretning til en sprøjte ifølge den fore-liggende opfindelse sammen med en stempelkrop, 5 fig. 11 indretningen i fig. 10 set efter linien 13-13, og fig. 12 den i fig. 10 viste indretning set fra siden,The invention is explained in more detail below with reference to the drawing, in which fig. 1 shows a typical syringe which could make use of the present invention; FIG. 2 is an isometric part of a syringe according to the invention with a gutter-shaped element arranged in place in the interior of the cylinder; FIG. 3 is a side view of the gutter-shaped element disposed within the syringe; FIG. 4 shows the gutter-shaped element of FIG. 3 is a side view and 20 outside the syringe; FIG. 5 shows the embodiment of FIG. 3 from below, fig. 6 is isometric that of FIG. 3-5 in the operating position shown in FIG. 7 is a sectional view taken along line 3-3 of FIG. 1, showing the position of the gutter-shaped element prior to use of the syringe; FIG. 8 shows the syringe of FIG. 7 with the measuring tube filled with medicine, DK 171855 B1 4 fig. 9 shows the syringe of FIG. 7 after administration of the medicine and with the plunger locked up against the end of the measuring tube; FIG. Fig. 10 shows another device for a syringe according to the present invention together with a piston body; 11 the device of FIG. 10 taken along line 13-13, and FIG. 12 is the one shown in FIG. 10 is a side view,

Som det fremgår af fig. 1, angår foreliggende opfindelse en stiv plastsprøj te, som har en hovedcylinder 2, en øvre skive -formet del 4, der strækker sig udad og er indrettet til at 10 lette indgivelsen af medikamentet, en dup 6, som udgør afslutningen af den ydre ende af en stempelenhed, som vil blive beskrevet nedenfor, og et indgivelseselement 8, som strækker sig ud fra næsen 7.As shown in FIG. 1, the present invention relates to a rigid plastic syringe having a main cylinder 2, an upper disc-shaped portion 4 extending outwardly and adapted to facilitate the administration of the drug, a duct 6 constituting the end of the outer end. of a plunger assembly, as will be described below, and a delivery member 8 extending from the nose 7.

Idet der henvises til fig. 2, er duppen 6, der ses i den 15 nedre del af denne figur, forbundet med eller tildannet ud i et med stempelenheden 10. Stempelenheden 10 har i hovedsagen X-formet tværsnit med ben 12 og en central forbindende cylindrisk del 14. En stempeldel 16, der har tætningselementer 18, fuldender stempelenheden ved den modsat duppen 6 liggende 20 ende. I det væsentlige midt på stempelenheden er der i denne figur vist en del af en cylinder 2 og et deri anbragt rende-formet element 30.Referring to FIG. 2, the plug 6, seen in the lower part of this figure, is connected to or formed in one with the piston unit 10. The piston unit 10 has generally X-shaped cross-section with legs 12 and a central connecting cylindrical part 14. A piston part 16 having sealing elements 18 completes the piston assembly at the opposite end 20 of the cap 6. Essentially, in the middle of the piston unit, a portion of a cylinder 2 and a gutter-shaped element 30 are shown in this figure.

Fig. 4 viser set ovenfra det tynde rendeformede element af metal, der omfatter ben 30, 32, som har en let indsnævret del 25 34. Ved deres øvre ende er benene adskilt ved hjælp af en slids 40, der ender i den nedre del med en spændingsnedsæt-tende bueformet del 42.FIG. 4 is a plan view of the thin gutter element of metal comprising legs 30, 32 having a slightly narrowed portion 25 34. At their upper end, the legs are separated by a slot 40 ending in the lower portion with a tension cut -tight arch-shaped part 42.

Fig. 5 viser det rendef ormede element set fra enden, og som det fremgår, står benene 30 og 32 vinkelret på hinanden og 30 buer udad og er tilspidset ved den øvre ende, der indbefatter DK 171855 B1 5 en mejseldel 36 og en spids tap 38.FIG. 5 shows the gutter-shaped element seen from the end, and as can be seen, the legs 30 and 32 are perpendicular to each other and 30 arches outwards and are tapered at the upper end, which includes a chisel portion 36 and a pointed pin 38.

De indre dele 36, som er i berøring med stempelstangen 10, er indrettet således, at en bevægelse i forhold til de to tilstødende elementer i en retning sker i det væsentlige uden 5 modstand, medens bevægelse i den modsatte retning bevirker, at delene 36 graver sig ned i stempelstangen. Tilsvarende vil de udadragende dele 38 let bevæge sig i et retning langs indersiden af cylinderens 2 væg, men ethvert forsøg på en relativ bevægelse i den modsatte retning vil bevirke, at delene 10 38 trænger ind i cylinderens 2 indervæg.The inner parts 36 in contact with the piston rod 10 are arranged so that movement relative to the two adjacent elements in one direction occurs substantially without resistance, while movement in the opposite direction causes the parts 36 to dig. descend into the piston rod. Similarly, the outwardly extending portions 38 will readily move in a direction along the inside of the wall of the cylinder 2, but any attempt at relative movement in the opposite direction will cause the portions 10 38 to penetrate the inner wall of the cylinder 2.

Den mest ensartede drift vil fremkomme ved til det rendefor-mede element at benytte et materiale, som har hukommelse og er hårdt, såsom rustfrit stål, og til selve sprøjten benytte et plastmateriale. Forskellen mellem hårdheden af de to mate-15 rialer tillader det rendeformede element at virke mod relativ bevægelse af de tilstødende elementer, idet det trænger ind i det bløde materiale og forhindrer yderligere bevægelse.The most uniform operation will be obtained by using the gutter-shaped element with a memory and hard material, such as stainless steel, and using a plastic material for the syringe itself. The difference between the hardness of the two materials allows the gutter-shaped element to act against relative movement of the adjacent elements as it penetrates the soft material and prevents further movement.

Fig. 7 viser indretningen set i tværsnit og uden kanyle og i en tilstand, hvor sprøjten er tom og klar til brug. Det skal 20 bemærkes, at stempeldelen 16 befinder sig nær næsen 7, og det rendeformede element 30 er beliggende i en forudbestemt afstand fra hulrummets bagende, således at der ved tilbagetrækning af stempeldelen til dette punkt vil blive trukket en forudbestemt mængde af et medikament ind i cylinderen med hen-25 blik på indgivelse af dette. Det rendeformede element 30 er forhindret i at bevæge sig bagud på grund af, at spidserne 38 er fastlåst til cylinderens indervæg. Stempelenheden kan imidlertid frit bevæge sig i denne retning.FIG. 7 shows the device seen in cross-section and without a cannula and in a state where the syringe is empty and ready for use. It should be noted that the plunger portion 16 is located near the nose 7 and the gutter member 30 is located at a predetermined distance from the rear of the cavity, so that upon withdrawal of the plunger portion to this point, a predetermined amount of a drug will be drawn into the the cylinder for administration thereof. The gutter member 30 is prevented from moving backward because the tips 38 are locked to the inner wall of the cylinder. However, the piston unit can move freely in this direction.

Det skal bemærkes, at det rendeformede element 30 ifølge op-30 findelsen kan benyttes til at styre sprøjtevolumenet i afhængighed af dens oprindelige placering.It should be noted that, according to the invention, the gutter-shaped element 30 can be used to control the spray volume depending on its original location.

Fig. 8 viser sprøjten ifølge opfindelsen med stempeldelen 16 DK 171855 B1 6 trukket tilbage til en position nær det rendeformede element 30, hvorved cylinderen er fyldt med medikamentet og stempelenheden forhindret i at blive bevæget yderligere bagud af det rendeformede element 30 og dennes spidser, som er i indgreb 5 med cylinderens 2 indervæg.FIG. 8 shows the syringe according to the invention with the piston part 16 DK 171855 B1 6 retracted to a position near the gutter member 30, whereby the cylinder is filled with the drug and the piston unit is prevented from being moved further backward by the gutter member 30 and its tips which are in the engaging 5 with the inner wall of the cylinder 2.

Som det fremgår af fig. 9, har stempelenhedens 10 fremadgående bevægelse, når medikamentet er blevet anvendt, ført det rendeformede element 30 frem til dets forreste stilling, hvor det fastlåser stemplet 16 til cylinderens 2 forende. Det ren-10 deformede element er blevet bevæget fremad ved samvirken med stempelenheden. Forsøg på at bevæge stempelenheden bagud vil bevirke, at spidserne 38 på det rendeformede element kommer i indgreb med cylinderens 2 indervæg og forhindrer en yderligere bagudgående bevægelse.As shown in FIG. 9, the forward movement of the piston unit 10, when the drug has been used, has guided the gutter-shaped element 30 to its forward position, where it locks the piston 16 to the front of the cylinder 2. The pure-shaped element has been moved forward by its interaction with the piston unit. Attempting to move the piston unit backwards will cause the tips 38 of the gutter-shaped element to engage the inner wall of the cylinder 2 and prevent further backward movement.

15 Det begrænsende rendeformede element er således anbragt mellem den indre væg af sprøjtens 2 cylindriske del og stempelenhedens ben 12, at mejseldelen 36 vil grave sig ind i stempelenhedens ben 12, når der er en relativ bevægelse herimellem i en retning, medens en relativ bevægelse i den anden 2 0 retning vil ske i det væsentlige uden modstand. Den spidse tap eller sporen 38 vil grave sig ind i cylinderens 2 sidevæg, når der herimellem er en relativ bevægelse i en retning, medens en relativ bevægelse i den anden retning vil ske i det væsentlige uden modstand. Stempelenheden kan således trækkes 25 tilbage, hvorved der trækkes fluidum ind i cylinderen, indtil stemplet 16 i fig. 2 forhindres i at blive bevæget yderligere udad p.g.a. af det rendeformede element, der er i indgreb med cylinderens 2 væg. Under indsprøjtningsprocessen vil det rendeformede elements 36 mejseldel være i indgreb med stempelen-30 hedens ben og vil blive bevæget nedad sammen med stempelstangen, indtil fluidumet er indsprøjtet. Det rendeformede element forhindrer herefter en bagudgående bevægelse af stempelenheden ved hjælp af sporen 38, som atter vil trænge ind i cylinderens 2 sidevæg.Thus, the limiting gutter member is disposed between the inner wall of the cylindrical portion of the syringe 2 and the piston unit leg 12 that the chisel portion 36 will dig into the piston unit leg 12 when there is relative movement therebetween in one direction while a relative movement of the the other direction will be substantially without resistance. The pointed pin or groove 38 will dig into the sidewall of the cylinder 2 when there is a relative movement in one direction, while a relative movement in the other direction will occur substantially without resistance. Thus, the piston unit can be withdrawn 25, thereby drawing fluid into the cylinder until the piston 16 in FIG. 2 is prevented from being moved further outwards due to of the gutter-shaped element which engages the wall of the cylinder 2. During the injection process, the chisel portion of the gutter member 36 engages the legs of the plunger unit 30 and will move downwardly with the piston rod until the fluid is injected. The gutter-shaped element then prevents a backward movement of the piston unit by means of the groove 38, which will again penetrate into the side wall of the cylinder 2.

Claims

A disposable syringe comprising an elongated hollow cylindrical container (2) having an inner side wall, a proximal end, a distal end and a nozzle (8) closing the distal end of the container (2), a piston unit 10 mounted axially movable within the container (2) to draw fluid into and drive it out of the container (2) through the nozzle (8), and comprising a piston rod extending out of the container DK 171855 B1 (2) thereon. proximal end and provided with a plunger (16) at the distal end, and a control device which can be positioned between the plunger rod and the inner wall at a location which determines the volume of syringe to be filled with a medicament characterized by: the guide means comprising a gutter-shaped member having legs (30, 32) extending outwardly and pointed at the outer end, and having a groove portion (38) of a material which is harder than the inner side wall and is in contact with and inclined 10 towards the inner side eggs, so that the control device can move freely towards the distal end, but a movement of the piston rod in proximal direction after the piston touches the distal part of the control means causes its groove part (38) to penetrate the inner side wall to prevent further movement of the piston (16) and the guide device in proximal direction, and a chiseled portion (36) in contact with and biased against the piston rod so that the piston rod can move freely for the first time towards the proximal end, but a movement of the piston rod towards it. distal end causes the chiseled portion (36) to engage the piston rod so that the control device along with the piston rod moves toward the distal end, which arrangement is such that the control device allows the syringe to be filled with a volume of the drug; determined by the control device by moving the piston (16) in proximal direction to the distal control of the control device. and after depressing the piston rod to expel the drug, any other movement of the piston rod in proximal direction is prevented by the spore-shaped portion (38) penetrating the inner side wall.

A disposable syringe comprising an elongated hollow cylindrical container (2) with an inner side wall, a proximal end, a distal end and a nozzle (8) closing the distal end of the container (2), a piston unit (10) which is arranged axially movable within the container (2) to draw fluid into and drive it out of the container (2) through the nozzle (8) and comprising a plunger rod extending out of the container (2) DK 171855 B1 at the proximal end and provided with a plunger (16) at the distal end and a control device which can be positioned between the plunger rod and the inner wall at a location which determines the volume of syringe to be filled with a medicament , characterized in that the control device is formed by a bent metal wire having the shape of a distorted U and comprising a pair of upwardly extending outwardly extending arms (52), each pointed to a chiseled tip (54), so that when is arranged between the inner side wall of the container (2) and the piston unit 1, the piston rod can be moved freely for the first time towards the proximal end, but a movement of the piston rod in the distal direction causes the chiseled portion (54) to engage the piston rod so that the control unit moves with the piston rod towards the distal end. Such arrangement is such that the control device allows the syringe to be filled with a volume of the drug determined by the control device, by moving the plunger in a proximal direction to the distal end of the control device and after depressing the plunger rod to expel the drug. , any other movement of the piston rod in proximal direction is prevented by the groove portion (54) penetrating the inner side wall.

Syringe according to claim 1 or 2, characterized in that the piston rod has longitudinally extending flat legs 25 (12) with surfaces arranged to engage the chisel-shaped part (36, 56) and one of the the chisel-shaped tips (54).

Syringe according to claim 1, characterized in that the control device includes a second groove-shaped part (38) and a second chisel-shaped part (36).

Syringe according to claim 4, characterized in that the chisel-shaped part (36) and the other chisel-shaped part (36) are separated by a longitudinal slot (40) in the control device, so that the chisel-shaped part (36) and the other In the proximal direction, the chiseled portion (36) extends in a protruding, resilient manner from the distal end of the control device and presses the groove portion (38) and the second groove portion (38) against the inner side wall of the container (2).

Syringe according to claim 4, characterized in that the piston rod has at least two longitudinally extending flat legs (12) with surfaces adapted to engage the chisel-shaped part (36) and the second chisel-shaped part (36). ) and is arranged such that the chiseled 10 parts engage in different planar legs (12).

Syringe according to claim 6, characterized in that at least two of the planar legs (12) extend substantially perpendicular to each other to form a V-shaped axial groove extending over the length of the piston rod which is adapted to engage with the control device.

Spray according to claim one or more of the preceding claims, characterized in that the container (2) is made of plastic.

Syringe according to claim one or more of the preceding claims, characterized in that the control device is made of metal.

Syringe according to claim 8, characterized in that the control device is made of metal plate.

Syringe according to claim 10, characterized in that the metal plate is stainless steel. DK 171855 B1

Syringe according to claim 1, characterized in that the piston rod has a plurality of longitudinal planar legs (12) and that the control device is located only between adjacent legs of the piston rod. 5