SI8811284A - Device for injecting syringes - Google Patents

Device for injecting syringes Download PDF

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SI8811284A
SI8811284A SI8811284A SI8811284A SI8811284A SI 8811284 A SI8811284 A SI 8811284A SI 8811284 A SI8811284 A SI 8811284A SI 8811284 A SI8811284 A SI 8811284A SI 8811284 A SI8811284 A SI 8811284A
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Slovenia
Prior art keywords
injection
solution
wall
reservoir
holder
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SI8811284A
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Slovenian (sl)
Inventor
Birger Hjertman
Anders Stroem
Ebba Florin-Robertson
Bo Ahlstrand
Linda Fryklund
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Pharmacia & Upjon Aktiebolag
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Priority claimed from SE8702735A external-priority patent/SE465065B/en
Priority claimed from SE8801405A external-priority patent/SE464797B/en
Application filed by Pharmacia & Upjon Aktiebolag filed Critical Pharmacia & Upjon Aktiebolag
Priority claimed from YU128488A external-priority patent/YU46917B/en
Publication of SI8811284A publication Critical patent/SI8811284A/en

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Abstract

Izum se nanašana napravo za vbrizgavanje injekcij, za pripravo raztopine emulzije ali suspenzije občutljivega zdravila v vodni raztopini in za vbrizgavanje istega. Pri napravi v smislu izuma se uporablja neka dvokomorna cilindrična ampula (1), ki je sicer poznana, zaradi mešanja vodnega medija (11) in zdravila (10), pri čemer se vodni medij (11) primora, da mirno teče od spodaj navzgor skozi zdravilo (10), da se prepreči tresenje in mešanje zraka. Priporočljivo je, da se mešanje vrši pri tlaku, ki je višji od atmosferskega. Naprava v smislu izuma za vbrizgavanje injekcij za pripravo raztopine za vbrizgavanje, za čemer sledi vbrizgavanje te raztopine, ima prednji element (13), ki obsega nek dvokomorni valj (1), v katerem je suho zdravilo (10) ločeno od tekoče faze (11) in zadnji element (14), ki obsega mehanizem (22) za doziranje in izdajanje. Ko se ta elementa privijeta drug v drugega, se tekoča faza (11) pomeša s suhim zdravilom (10) in ga raztopi, gotova raztopina pa se potem lahko vbrizga s pomočjo mehanizma(22) za doziranje in izdajanje preko igle (17), nameščene pri sprednjem koncu sprednjega elementa (13). Izum bo za zdravila, občutljiva na mehanski vpliv, omogočil, da se mešanje suhe snovi in vodnega medija kot tudi nadaljnje manipuliranje pripravljenega agensa lahko izvede tako nežno, daje izguba kvalitete zdravil zaradi mehanskih vplivov zmanjšana na minimum.The invention relates to an injection device injection, to prepare an emulsion or suspension solution sensitive drug in aqueous solution and for injection of the same. In the apparatus of the invention, uses a two-chamber cylindrical ampoule (1) which otherwise known for mixing aqueous medium (11) and medicaments (10), wherein the aqueous medium (11) is forced, that it flows peacefully from the bottom up through the medicine (10), to prevent shaking and stirring of air. Recommended is that mixing is carried out at a pressure higher than atmospheric. A device according to the invention for injection injections to prepare the injection solution, followed by injection of this solution has a front element (13) comprising a two-chamber cylinder (1), v wherein the dry drug (10) is separated from the liquid phase (11) and the last element (14) comprising the mechanism (22) for dispensing and dispensing. When these elements are screwed into each other, the liquid phase (11) is mixed with the dry phase (10) and dissolve it and the final solution is dissolved it can then be injected using the mechanism (22) for dosing and dispensing via a needle (17) arranged at the front end of the front member (13). It will be an invention for drugs sensitive to mechanical impact, allowed mixing dry matter and aqueous medium as well further manipulation of the prepared agent may performs so gently that the loss of quality of the medicines results mechanical effects minimized.

Description

UREDAJ ZA UBRIZGAVANJE INJEKCIJAINJECTION INJECTION DEVICE

Dosije : 3574 .--P-12M/38Files: 3574 .-- P-12M / 38

KABIVITRUM AB Stockholm, ŠvedskaKABIVITRUM AB Stockholm, Sweden

Oblast tehnike u koju spada pronalazakFIELD OF THE INVENTION

Pronalazak spada u oblast uredaja za unošenje agenasa u telo, a posebno se odnosi na brizgalice za injekcije. Oznaka Prema Medunarodnoj klasifikaciji patenata :The invention falls within the field of apparatus for injecting agents into the body, and particularly relates to syringes for injection. Designation According to the International Patent Classification:

A 61 M 5/24.A 61 M 5/24.

Tehnički problemTechnical problem

Pronalaskom se resava problem kako konstrukcijski izvesti uredaj za ubrizgavanje injekcija koji de omoguditi nošenje ampula sa dvokomponentnim medikamentima i mešanje tih. obično osetljivih komponenata kod ubrizgavanja.The invention solves the problem of how to construct an injection device which will allow carrying ampoules with two-component medicaments and mixing them. usually sensitive components when injected.

Stanje tehnikeThe state of the art

Ovaj se pronalazak odnosi na uredaja za ubrizgavanje injekcija, posebno za upotrebu u ambulantnom lečenju. Tačnije, pronalazak 'se odnosi na uredaj pomodu kojeg se rastvor za ubrizgavanje neke materije, supstance, priprema neposredno pre ubrizgavanja, ili se priprema nekoliko doza pre prve injekcije.The present invention relates to injection devices, especially for use in outpatient treatment. More specifically, the invention refers to a device by which a solution for injecting a substance, a substance, is prepared immediately before injection, or several doses are prepared before the first injection.

Uredaji za ubrizgavanje injekcija u ambulantnom lečenju gde se medikament nalazi u rastvoru, poznati sil od ranije i široko su koriščeni, na primer, kod lečenja šederne bolesti insulinom. Takvi uredaji su obično načinjeni tako da sam pacijent može da sklopi lako jednu cilindričnu ampulu za jednu ili više doza, jednu iglu za injekcije i napravu za doziranje u jednom pogodnom držaču, posle čega može sebi lako da da potrebnu injekciju. Kod tog uredaja se lako mogu zameniti ampule i igle novim. U sklopljenom stanju su takvi uredaji. za ubrizgavanje često oblikovani kao naliv pero i pacijent ih može lako nositi sa sobom.Injection injection devices in outpatient treatment where the medicament is in solution, a known force from before and have been widely used, for example, in the treatment of insulin malignancy. Such devices are usually designed so that the patient can easily assemble one cylindrical ampoule for one or more doses, one injection needle and dosing device in one convenient holder, after which he can easily give himself the injection required. Ampoules and needles can easily be replaced with new ones. In the assembled state are such devices. for injection often shaped like a fountain pen and the patient can easily carry them with them.

Pored toga, poznati su tzv. dvokomorni ili sudovi za,mešanje ili cilindrične ampule za pripremanje rastvora oset1jivih supstanci neposredno pre ubrizgavanja. Takvi sudovi su podeljeni na dve komore razdvojene jednim pomerljivim zidom ili klipom. Osetljivi medikament se nalazi u prednjoj komori u suvom, obično zamrzovanjem osušenom stanju, a prednji kraj prednje komore je zaptivno zatvoren jednim zidom koji može da probije igla za Injekcije.. Tečnost koja treba da rastvori osetljivu supstancu pre ubrizgavanja nalazi se u zadnjoj komori. Dve komore su razdvojene prednjim pomerljivim zidom, .a zadnji kraj zadnje komore je zaptivno zatvoren pomodu zadnjeg pomerijivog zida. Pored toga, u zidu suda je izveden spojni kanal koji može da poveže prednju i zadnju komoru.In addition, the so-called. two-chamber or container for mixing, or cylindrical ampoules for the preparation of a solution of sensitive substances just before injection. Such vessels are divided into two chambers separated by a single moving wall or plunger. The sensitive drug is located in the anterior chamber in a dry, usually freeze-dried state, and the anterior end of the anterior chamber is sealed with a single wall that can be punctured by the Injection Needle. The fluid to dissolve the sensitive substance prior to injection is located in the posterior chamber. The two chambers are separated by a front movable wall, .and the rear end of the rear chamber is sealed by the rear movable wall. In addition, a connection duct was constructed in the vessel wall that could connect the front and rear chambers.

U položaju uskladištenja pre ubrizgavanja/ nema veze izmedu prednje i zadnje komore. Ulaz, kao i izlaz spojnog kanala završava se u prednjoj komori.In storage position before injection / no connection between front and rear chamber. The inlet as well as the outlet of the connecting duct ends in the front chamber.

Kada kontejner treba da se pripremi za ubrizgavanje, zadnji pomerijivi zid u zadnjoj komori pomera se prema napred, a zbog nestišl jivosti tečnosti, i prednji pomerljivi zid če se pbmerati u napred dok ne dostigne položaj naspram spojnog kanala u zidu kontejnera. Kada se posle toga zadnji pomerljivi zid pomera i dalje u napred, tečnost če biti potisnuta kroz prelivni kanal u prednju komoru gde če doči u dodir sa medikamentom i isti rastvoriti. Kod ubrizgavanja če ta dva zida da deluju zajedno kao jedan klip i istisnuti pripremljeni rastvor za ubrizgavanje kroz jednu iglu koja je umetnuta kroz prednji krajnji zid u prednjo j komori..When the container is to be prepared for injection, the rear displacement wall in the rear chamber moves forward, and due to fluid incompatibility, the front displacement wall will also move forward until it reaches a position opposite the connecting channel in the container wall. When, after that, the rear moving wall continues to move forward, the fluid will be pushed through the overflow duct into the anterior chamber where it will come into contact with the drug and dissolve it. On injection, these two walls will act together as one piston and squeeze the prepared injection solution through a single needle inserted through the front end wall into the anterior chamber.

U nekim slučajevima medikament može biti toliko osetljiv, da se moraju preduzimati posebne mere da se supstanca zaštiti od mehaničkih uticaja u trenutku rastvaranja kao i pri daljem rukovanju rastvorom, To vaši, na primer, na zamrzavanjem sušene hormone rasta gde čak i jednostavno tresenje supstance i tečnosti mpže dovesti do neprihvatljivih biohemijskih promena.In some cases, the medication may be so sensitive that special measures must be taken to protect the substance from mechanical influences at the time of dissolution as well as further handling of the solution, your own, for example, freezing of dried growth hormones where even simple shaking of the substance and mpj liquids lead to unacceptable biochemical changes.

Zbog toga priprema kontejnera za ubrizgavanje mora da se izvede sa največom mogučom paznjom.Therefore, the preparation of the injection container must be carried out with the utmost care.

Bilo bi veoma poželjno da se ima na raspolaganju uredaj za ubrizgavanje injekcija koji se može lako nositi i primenjivati kao do sada poznate jednostavne cilindrične ampule, u kojima se medikament nalazi u tečnom stanju kao rastvor, suspenzija ili emulzija, a koji če istovremeno moči da koristi prednosti kontejnera za mešanje kod ubrizgavanja osetljivih supstanci. Taj cilj je postignut prikazanim pronalaskom.It would be highly desirable to have an injectable injection device that can be easily worn and used as a known simple cylindrical ampoule, in which the medicament is in liquid state as a solution, suspension or emulsion, and which can be used simultaneously the advantages of mixing containers for the injection of sensitive substances. This object was achieved by the present invention.

Opis rešenja tehničkog problemaDescription of solution to a technical problem

Prema pronalasku ostvaren je uredaj za pripremu rastvora za ubrizgavanje jedne ili više supstanci osetljivih na opadanje svojstava, I za ubrizgavanje tog rastvora.According to the invention, a device for preparing a solution for the injection of one or more substances sensitive to decaying properties, and for injecting that solution, is provided.

Cilj je uredaja prema pronalasku da se njime pripremi rastvor, emulzija ili Suspenzija u vodi jednog ili više osetljivih medikamenata ža jedno ili više ozastopnih ubrizgavanja, koriščenjem jedne poznate višekomorne cilindrične ampule, koja obuhvata prednji prostor koji sadrži osetljivi medikament i zaptivno je zatvoren na svom prednjem kraju jednom membranom koju može da probije igla za injekcije, a ograničen je sa zadnje strane prednjim pomerljivim zidom, zatim zadnji prostor koji sadrži jednu vodenu fazu, a koji je na prednjem kraju ograničen prednjim pomerljivim zidom, i ograničen je sa zadnje strane zadnjim pomerljivim zidom, kao i jedan spojni kanal izveden u zidu ampule izmedu zadnjeg i prednjeg prostora, pri čemu se zadnji pomerijivi zid pomera prema napred i pokreče vodenu fazu i prednji pomerljivi zid, sve dok ne dospe naspram prelivnog kanala, tako 'da tečna faza pri daljem kretanju u napred zadnjeg pomerljivog zida teče pored prednjeg pomerljivog zida u prednji prostor i rastvara, emulguje ili susperiduje medikament. Ono što je karakteristično za uredaj je to, što vodena faza teče mirno odozdo naviše kroz medikament pri čemu se izbegava tresenje i mešanje vazduha.The object of the invention is to provide a solution, emulsion or suspension in water of one or more sensitive medicaments for one or more successive injections, using a known multi-chamber cylindrical ampoule, comprising an anterior space containing a sensitive medicament and sealed at its front the end with a single membrane that can be punctured by the injection needle, which is bounded on the back by a front moving wall, then a back space containing a single aqueous phase and bounded on the front end by a front moving wall, and bounded on the back by a rear moving wall , as well as one connecting channel made in the wall of the ampoule between the posterior and anterior space, with the rear displacement wall moving forward and moving the water phase and the front displacement wall until they reach the overflow channel so that the liquid phase on further movement into the front of the rear moveable wall flows past the front moveable wall into the front it dissolves, emulsifies or suspends the drug. What is characteristic of the device is that the aqueous phase flows quietly from below through the medicament, avoiding shaking and stirring of air.

Za uredaj prema pronalasku karakteristično je to, što obuhvataThe device according to the invention is characterized by the fact that it comprises

a) kontejner za sastavne elemente rastvora za ubrizgavanje, u kome se te komponente drže razdvojene, ali se mogu omešati dejstvom spolja da bi se mešali i rastvorili, a koje je izvedeno u vidu cevi koja je zaptivno zatvorena na svom prednjem' kraju pomuču jedne membrane koja se može probiti, pri čemu se u jednom prostoru izmedu zida koji se može probiti i jednog prednjeg pomerljivog zida drže čvrste komponente rastvora za ubrizgavanje, a U prostoru izmedu prednjeg pomerljivog zida i jednog zadnjeg pomerljivog zida drže se tečne komponente rastvora za ubrizgavanje, dok je u cevastom zidu izveden jedan spojni kanal, postavljen tako da, kada se zadriji pomerljivi zid pomeri u napred zajedno sa tečnošču i prednjim pomerljivim zidom, tečnost može da teče pored prednjeg pomerljivog zida i da se meša sa čvrstim komponentama i obrazuje rastvor;a) a container for the components of an injection solution, in which these components are kept separate but may be limited by the action outside to mix and dissolve, which is made in the form of a tube sealed at its front end by a single membrane breakable, with solid components of the injection solution held in one space between the breakable wall and one front moving wall, and liquid components of the injection solution held in the space between the front moving wall and one rear moving wall, while a conduit is arranged in the tubular wall so that when the sliding moving wall moves forward along with the fluid and the front moving wall, the fluid can flow past the front moving wall and mix with the solid components and form a solution;

b) Držač u koji se može učvrstiti kontejner tako da se komponente rastvora za ubrizgavanje dovedu u .dodir i pomešaju, a koji je načinjen od dva cevasta'elementa koji se mogu spojiti navojem i obuhvatiti kontejner, tako da kada se ovi elementi spoje navojem, prednji kraj kontejnera je sa membranom koja se može probiti izložen kod prednjeg kraja držača da bi bio probijen iglom za irijekcije, pri čemu se zadnji pomerljivi zid kod zad4 njeg kraja kontejnera pomera u napred zajedno sa tečnošču i sa prednjim pomerijivim zidom tako da je tečnost primorana da teče kroz'spojni kanal u prostor čvrstih komponenata, da bi se sa istima mešala i obrazovač rastvor;b) A holder in which a container can be secured so that the components of the injection solution are brought into .dadir and mixed, and which is made of two tubular'elements that can be threaded and enclosed by the container so that when these elements are threaded. the front end of the container is exposed with a permeable membrane exposed at the front end of the holder to be punctured by the injection needle, with the rear moving wall at the rear end of the container moving forward together with the fluid and the front moving wall so that the fluid is forced. to flow through the junction channel into the space of the solid components, in order to mix the same with the former solution;

c) držač igle za injekcije koja je podešena da se postavi na prednji kraj držača kontejnera, tako da se igla može spojiti sa unutrašnjošču kontejnera kroz membranu koja se može probiti, ic) an injection needle holder adapted to be mounted on the front end of the container holder so that the needle can be connected to the interior of the container through a permeable membrane, and

d) naprava za doziranje povezana sa držačem kontejnera, čijim se delovanjem zadnji pomerljivi zid u kontejneru pomera u napred ispuštajuči pri torne odredene doze rastvora za ubrizgavanje, pri čemu se naprava za doziranje dovodi u pocetni položaj za doziranje kada se delovi držača kontejnera spojeni navojem.d) a dosage device coupled to a container holder, the action of which the rear movable wall in the container moves in forward discharging at a predetermined dose of the injection solution, the dosing device being brought to the initial dosing position when the parts of the container holder are threaded.

• Pronalazak takode obuhvata jednu univerzalnije upotrebljivu napravu za pripremanje rastvora za ubrizgavanje od komponenata postavljenih u kontejner prema tački a) napred.• The invention also encompasses a more universally usable device for preparing injection solutions from components placed in the container according to a).

U sledečem tekstu pronalazak je detaljnije opisan sa pozivom na priložene crteže.The invention will now be described in more detail with reference to the accompanying drawings.

Jedno izvodenje uredaja prema pronalasku prikazano je na crtežima.One embodiment of the device according to the invention is shown in the drawings.

Slika 1 načrta prikazuje dvokomornu cilindričnu ampulu koja ima dve komore za primenu u uredaju za ubrizgavanje.Figure 1 shows a two-chamber cylindrical ampoule having two chambers for administration in an injection device.

Slika 2 predstavlja opšti izgled. uredaja za ubrizgavanje prema pronalasku.Figure 2 represents the general layout. injection devices according to the invention.

Slika 3 prikazuje isti uredaj u rastavljenom stanju. Slika 4 je presek uredaja u rastavljenom stanju. Slika 5 prikazuje uredaj spreman za ubrizgavanje. Slika 6 prikazuje, šematski, izgled prve varijante izvodenja uredaja prema pronalasku u položaju pre pripremanja rastvora za ubrizgavanje.Figure 3 shows the same device in disassembled state. Figure 4 is a cross-section of the device in disassembled state. Figure 5 shows the injection device. Figure 6 shows, schematically, the layout of the first embodiment of the device according to the invention in the position before preparing the injection solution.

Slika 7 prikazuje, šematski, izgled uredaja saFigure 7 shows, schematically, the layout of the device with

D . slike 6 nakon pripreme rastvora za ubrizgavanje.D. 6 after preparation of the injection solution.

Slika 8 predstavlja, šematski, izgled uredaja prikazanog na slikama 6 i 7 pri unošenju pripremljenog rastvora u iglu za injekcije.Figure 8 is, schematically, a layout of the apparatus shown in Figures 6 and 7 when injecting the prepared solution into a needle for injection.

Slika 9 prikazhje, šematski, izgled druge varijante izvodenja pronalaska u položaju pre priprema rastvora za ubrizgavanje. 'Figure 9 shows, schematically, a layout of another embodiment of the invention in position before preparing the injection solution. '

Slika 10 prikazuje, šematski, izgled uredaja sa slike 9 nakon pripreme rastvora za ubrizgavanje.Figure 10 shows, schematically, the layout of the apparatus of Figure 9 after preparation of the injection solution.

Sslika 11 prikazuje, šematski, izgled uredaja prema slikama 9 i 10 sa postavijenom cevčicom, kanulom, pripremljen za ubrizgavanje.FIG. 11 shows, schematically, the layout of the apparatus of FIGS. 9 and 10 with the tube, cannula fitted, prepared for injection.

Presek dvokomorne cilindrične ampule koja se koristi u uredaju za ubrizgavanje prema pronalasku prikazan je na slici 1. Ampula se sastoji od cevi 1, preporučljivo od stakla ili plastične mase, koja je izvedena sa grlom sa prirubnicom 2 na njegovm prednjem kraju. Prednji kraj je zaptivno zatvoren membranom 3 načinjenom od gume ili pogodnog plastičnog materijala, koja je pričvrščena metalnom kapsulom 4. Kapsula 4 ima otvor.5 u svom srednjem delu, tako da je tu membrana 3' nepokrivena. Ivični deo kapsule je povijen oko prirubnice 2, tako da je membrana 3 pričvrščena na prednjem otvoru ampule.A cross-section of a two-chamber cylindrical ampoule used in the injection device of the invention is shown in Figure 1. The ampoule consists of a tube 1, preferably glass or plastic, which is made with a flanged neck 2 at its front end. The front end is sealed with a membrane 3 made of rubber or a suitable plastic material, which is secured by a metal capsule 4. The capsule 4 has an opening 5 in its middle region, so that the membrane 3 'is uncovered. The edge portion of the capsule is wound around the flange 2 so that the membrane 3 is attached to the front opening of the ampoule.

Ampula je podeljena na prednji prostor 6 i na zadnji prostor 7 pomoču pomerijive pregrade 8. Zadnji kraj ampule je zaptivno zatvoren pomerijivim zidom 9 koji, pri torne, takode zaptivno zatvara zadnju komoru 7. Dva pomerljiva zida 8 i 9 mogu da se pomeraju u napred u ampuli obezbedujuči zaptivanje uz zid ampule, pri čemu ova ampula u tom cilju ima kružno cilindrični oblik.The ampoule is divided into the front space 6 and the rear space 7 by means of a movable partition 8. The rear end of the ampoule is sealed by a movable wall 9 which, at friction, also seals the rear chamber 7. The two movable walls 8 and 9 can be moved forward in the ampoule providing a seal against the wall of the ampoule, wherein the ampoule has a circularly cylindrical shape for this purpose.

Prednja komora 6 ampule sadrži jedan ili više medikamenata 10 u suvom stanju, preporučljivo osušenih zamrzavanjem. U tom obliku i osetljive supstance imaju relativno dobru stabilnost. Zadnja komora 7 sadrži tečnu fazu 11 kojs je namenjena za rastvaranje suve supstance za ubrizgavanje. Ova tečna faza obično se sastoji od vode ili fiziološkog slanog rastvora,i takvih dodatnih supstanci koje su uobičajene u farmakološkoj praksi i mogu,se dodati rastvoru.The anterior chamber 6 of the ampoule contains one or more medicaments 10 in the dry state, preferably freeze-dried. Sensitive substances also have relatively good stability in this form. The rear chamber 7 contains a liquid phase 11 which is intended to dissolve the dry substance for injection. This liquid phase usually consists of water or saline, and such additional substances, which are common in pharmacological practice and may be added to the solution.

U zidu ampule je izveden spojni kanal, u vidu jednog .udubljenja koji je postavljen i pruža se u uzdužnom pravcu ampule. Prelivni kanal 12 je postavljen tako da je potpuno u prednjem prostoru 6 pre no-što je ampula pripremljena za ubrizgavanje, a dužina mu je takva da omogučuje protok pored pomerljivog zida 8.In the wall of the ampoule there is a conduit, in the form of a recess, which is mounted and extends in the longitudinal direction of the ampoule. The overflow duct 12 is positioned so that it is completely in the anterior space 6 before the ampoule is prepared for injection and its length is such that it allows flow past the movable wall 8.

Na slici 2 prikazan je uredaj za ubrizgavanje prema pronalasku u sklopljenom stanju tako da ga pacijent može lako da nosi sa sobom. Uredaj je obično oblikovan kao naliv-pero i sastoji se qd prednjeg kučišta 13 koje obuhvata jednu dvokomornu cilindričnu ampulu prema slici 1 za agens koji če se ubrizgati, zadnje kučište 14 koje obuhvata jedan mehanizam za doziranje i primenu agensa, i jednu zaštitnu kapu 15 preko igle za ubrizgavanje. Mehanizam za doziranje i primenu agensa načinjen je na jedan od poznatih načina i ovde neče biti detaljnije opisivan. Obično deluje na takav način da se upravljačko dugme 16 na zadnjem kraju uredaja okrene takoda se jedan indeks postavi naspram jedne skale čime se odreduje jedna pogodna doza.Figure 2 shows the injection device according to the invention in a folded state so that the patient can carry it easily with him. The apparatus is usually shaped as a fountain pen and consists of a qd front housing 13 comprising a two-chamber cylindrical ampoule according to Figure 1 for the injectable agent, a rear housing 14 comprising one mechanism for dispensing and administering the agent, and one protective cap 15 over injection needles. The mechanism for dosing and administration of the agent is made in one of the known ways and will not be described in more detail herein. It usually works in such a way that the control knob 16 on the rear end of the device rotates so that one index is placed against a single scale to determine one suitable dose.

Kod primene lekova, upravljačko dugme se pritisne čime se jedna odredena doza ispušta kroz iglu. Mnoga različita izvodenja takvog jednog mehanizma za doziranje i davanje lekova poznata su od ranije i mogu se koristiti u uredajima za ubrizgavanje prikazanog pronalaska.When administering the medication, the control knob is pressed allowing one particular dose to be discharged through the needle. Many different embodiments of such a single drug dosing and administration mechanism are known from the prior art and can be used in the injection devices of the present invention.

Na slici 3 je prikazan uredaj za ubrizgavanje u rastavljenom stanju. Ovde je skinuta i zaštitna kapa 15 tako da je prikazan prednji deo 17 igle sa njenim držačem 18. Igla se može navrnuti na prednji kraj prednjeg kučišta 13 pomoču.. ~ držača .i može se Iako zameniti. Posle toga se zaštitna kapa 1.5 mora držati, postavi j ena celo vreme kako bi se održala sterilnost.Figure 3 shows the disassembled injection device. The protective cap 15 is also removed here so that the front part 17 of the needle with its holder 18 is shown. The needle can be screwed to the front end of the front housing 13 with the aid .. ~ of the holder. And can be replaced though. Thereafter, the protective cap 1.5 must be kept in place and maintained at all times to maintain sterility.

i ne treba da se uklanja sve do neposredno pre’ ubrizgavanja. Na *and should not be removed until just before injection. Na *

prednjem kučištu 13 načinjen je otvor 19 kroz koji korisnik može Iako da proveri da li je neka ampula umetnuta i koliko je još preostalo rastvora za ubrizgavanje.the front housing 13 has an opening 19 through which the user can check to see if an ampoule is inserted and how much solution is left for injection.

Zadnje kučište 14 može se uvrnuti u prednje kučište 13 pomoču anvoja 20. Istovremeno sa uvim uvrtanjem, umetnuta dvokomorna cilindrična ampula za ubrizgavanje se priprema, što če biti detaljnije opisano u sledečem tekstu.The rear housing 14 can be screwed into the front housing 13 by means of anvoy 20. At the same time as the twist, a double-chamber cylindrical injection ampoule is prepared, which will be described in more detail below.

Slika 4 predstavlja izgled, delimično u uzdužnom preseku., rastavljenog uredaja za ubrizgavanje prema slici 3.Figure 4 is a partial view, in longitudinal section, of the disassembled injection device of Figure 3.

Ovde je očigledno da je dvokomorna cilindrična kapsula tipa prikazanog na slici 1 umetnuta u prednje kučište 13 i ppmerna toliko napred, da .je njena membrana 3 otkrivena kako bi je probušila igla. Uz.adnjem kučištu 14 je mehanizam za doziranje i ispuštanje šematski prikazan.i ožnačen sa 22. Taj mehanizam ima prema napred usmerenu radnu šipku 23. Aktiviranjem iste, dvokomponentna cilindrična ampula je prva pripremljena za ubrizgavanje, pa se posle toga odredene doze agensa za ubrizgavanje mogu rašpodeliti pomoču upravijačkog dugmeta 16.It is apparent here that a two-chamber cylindrical capsule of the type shown in Figure 1 is inserted into the front housing 13 and is so forward that its membrane 3 is exposed to be punctured by the needle. The rear housing 14 has a dosing and discharging mechanism schematically shown and marked with 22. This mechanism has a forward working rod 23. By activating the same, a two-component cylindrical ampoule is first prepared for injection, and then doses of the injection agent are determined thereafter. can distribute the help of the control knob 16.

Zadnje kučište 14 može se uvrnuti u prednje kučište 13 pomoču spoljneg navoja 20 koji se spreže sa unutrašnjim navojem 24.The rear housing 14 may be screwed into the front housing 13 by means of an outer thread 20 which is connected to the inner thread 24.

Slika 5 prikazuje uredaj sklopljen i spreman za ubrizgavanje. Ovde je zadnji pomerljivi zid 9 toliko pomeren. da je došao.u dodir sa prednjim pomerijivim zidom 8. Ovaj je pomeren toliko da je došao naspram spo.jnog kanala 12 i tečna je faza proticala pored prednjeg pomerijivog zida 8 i mešala se sa suvim medikamentom. Zašiljeni zadnji kraj 21 igle takode je probio kroz membranu 3. Dva pomerijiva zida 8 i 9 u medusobnom su dodiru pomereni su toliko da je sav vazduh iz prednjeg prostora 6 istisnut kroz iglu. Uredaj je spremanza ubrizgavanje.Figure 5 shows the device assembled and ready for injection. Here the rear sliding wall 9 is so displaced. that it came in contact with the front movable wall 8. This one was displaced so much that it came opposite the joint duct 12 and the liquid phase flowed past the front movable wall 8 and mixed with the dry medicament. The protruding rear end 21 of the needle also penetrated through the membrane 3. The two movable walls 8 and 9 were moved in contact with each other so that all the air from the front space 6 was expelled through the needle. The unit is ready for injection.

Funkcionisanje uredaj nakon što je pripremljen za ubrizgavanje je sledeče :The operation of the unit after it has been prepared for injection is as follows:

U zadnjem kučištu 14 .radna šipka 23 i kontrolno dugme 16 mehanizma 22 za doziranje' i raspodelu postave se' prvo na pocetni ili nulti položaj. To se čini na način koji je odreden konstrukcijom mehanizma koji je inače poznat. Potom se zadnje kučište 14 uvrče u prednje kučište 13 sve do se radna šipka 23 ne osloni ovlaš na zadnji pomerljivi zid 9 u dvokomornoj cilindrično j ampuli. ,In the rear housing 14, the working bar 23 and the control knob 16 of the dosing mechanism 22 and the positioning arrangement are first set to the starting or zero positions. This is done in a manner determined by the construction of a mechanism otherwise known. The rear housing 14 is then screwed into the front housing 13 until the working bar 23 rests properly against the rear movable wall 9 in the two-chamber cylindrical ampoule. ,

Ako se zadnje kučište i dalje uvrče, radna poluga če potisnuti zadnji pomerljivi zid 9 prema napred u cilindričnoj ampuli, a kako je tečnost 11 u zadnjem prostoru 7 u suštini. nesabitljiva, biče i prednji pomerljivi zid 8 potisnut prema napred. U prednjoj komori 6 javiče se izvestan natpritisak jer vazduh ne može da ode.If the rear housing is still screwed in, the operating lever will push the rear displacement wall 9 forward in the cylindrical ampoule, and since fluid 11 in the rear space 7 is substantially. non-destructive, the front movable wall 8 will also be pushed forward. In the front chamber 6, some overpressure occurs because the air cannot escape.

Kada prednji pomerljivi zid 8 bude potisnut dovoljno da se nade naspram prelivnog kanala 12, biče uspostavljena veza za tečnosti izmedu prednje i zadnje komore. Daljim kretanjem u napred zadnjeg pomerljivog ribara 9, tečnost če biti potisnuta u prednju komoru 6 kroz prelivni kanal 1.2. U ovom stupnju, ili fazi, prednji pomerljivi zid 8 neče se pomerati.·When the front movable wall 8 is pushed sufficiently to hopefully overflow channel 12, a fluid connection is made between the front and rear chambers. By moving further forward of the rear fisherman 9, the fluid will be pushed into the front chamber 6 through overflow channel 1.2. At this stage, or stage, the front sliding wall 8 will not move.

Kada sva tečnost bude potisnuta u prednji prostor, zadnji pomerljivi zid 9 dočiče u mehanički dodir sa prednjim pomerljivim zidom 8. Tečnost če rastvoriti suvi medikament 10 i obrazovati rastvor za ubrizgavanje spreman za upotrebu. DržaČ 18 sa priključenom iglom 17 navrče se posle toga na prednje kučište 13, pri čemu je membrana 3 cilindrične ampule probijena zadnjim vrhom 21 igle, a natpritisak u prednjoj komori je ispušten.When all the fluid is pushed into the anterior space, the rear displacement wall 9 comes into mechanical contact with the anterior displacement wall 8. The fluid will dissolve the dry medicament 10 and form a ready-to-use injection solution. The holder 18 with the needle attached 17 then inserts into the front housing 13, wherein the diaphragm 3 of the cylindrical ampoule is pierced by the rear tip 21 of the needle and the overpressure in the front chamber is discharged.

Daljim potiskivanjem upravljačkog dugmeta 16, radna šipka 23 se aktivira tako da se zidovi 8 i 9 pomeraju dalje u napred i vazduh u cilindričnoj ampuli če izači kroz iglu 17. Uredaj je sada spreman za ubrizgavanje kao što je prikazano na slici 5.By further pushing the control knob 16, the operating rod 23 is activated by moving the walls 8 and 9 further forward and the air in the cylindrical ampoule will flow through the needle 17. The device is now ready for injection as shown in Figure 5.

Kod pripremanja uredaja neophodno je da se drži vertikalno, sa iglom usmerenom naviše, a spajanje navojem ne c sme se vršiti suviše brzo. Na taj če se način tečnost mirno penjati kroz supstancu i rastvarati je, pri čemu nema jakog mešanja. Ovakvo jako mešanje je nepogodno za mnoge osetljive supstance jer može da utice nepovoljno na materiju.When preparing the appliance, it is necessary to hold it vertically, with the needle pointing upwards, and the thread connection must not be made too quickly. In this way, the liquid will calmly climb through the substance and dissolve it, without strong mixing. Such strong mixing is unsuitable for many sensitive substances as it can adversely affect the substance.

To je jedno preporučljivo izvodenje kod koga je dvokomorna cilindrična ampula 1 postavljena u prednje kučište 13 a čvrsti maedikament je rastvoren pre no što igla 21 probije membranu 3 ampule. Pošto se javlja natpritisak, tendencija penušenja i obrazovanja mehurova smanjena je kada su tečnost i čvrsti materijal pomešani, što je manje štetno za medikament. Medutim, za. medikamente koji nisu toliko osetljivi, držač 18 igle sa iglom može se navrnuti na prednji deo 13 kučišta pre no što je cilindrična ampula umetnuta i oba kučišta su medusobno spojena zavrtnjima. Zadnji vrh igle če zatim. probiti membranu 3 pre no što su čvrsta supstanca i tečnost pomešani £>This is one preferred embodiment in which the two-chamber cylindrical ampoule 1 is inserted into the front housing 13 and the solid maedicament is dissolved before the needle 21 pierces the membrane of the 3 ampoules. As overpressure occurs, the tendency for foaming and blistering is reduced when the fluid and solid material are mixed, which is less harmful to the drug. However, for. medicaments that are not so sensitive, the needle holder 18 can be threaded to the front of the 13 housing before the cylindrical ampoule is inserted and both cases are screwed together. The last tip of the needle will then. pierce membrane 3 before solids and liquids are mixed £>

pri čemu ne dolazi do natpritiska u komori za mešanje.without overpressure in the mixing chamber.

Kada uredaj treba sa se koristi za davanje leka ubrizgavanjem, prvo se skine zaštitna .kapa sa igle. Posle toga se odreduje Željena doza pomoču upravljačkog dugmeta 16 i pritiskivanjem upravljačkog dugmeta doza se‘ispušta kroz iglu. Posle toga se mogu davati sleče doze sva dok ima rastvora za injekcije u cilindričnoj ampuli.Posle svakog ispuštanja igla se-obično zamenjuje novom sreilnom iglom. Ovo se može lako učiniti odvrtanjem držača 18 sa priključenom iglom sa prednjeg kraja uredaja za ubrizgavanje posle čega se navrne novi držač sa iglom. Istovremeno če zadnji zašiljeni kraj igle probiti membranu i ostvariti vezu tečnosti do unutrašnjosti ampule.When the device is to be used to administer the drug by injection, the protective needle cap is first removed. The desired dose is then determined using the control knob 16 and the dose is released through the needle by pressing the control knob. Subsequently, sleet doses can be given as long as there is a solution for injection in a cylindrical ampoule. After each discharge, the needle is usually replaced with a new lucky needle. This can be easily done by unscrewing the needle retainer 18 from the front end of the injection device and then inserting the new needle retainer. At the same time, the last pointed end of the needle will pierce the diaphragm and connect the fluid to the inside of the ampoule.

Varijanta izvodenja prikazana na slici 6 obuhvsts .jedan držač u koji se može postaviti kontejner 1. Držač se sastoji od dva cevasta elementa koji se mogu spojiti navojem, i to prednjeg cevastog elementa 24 i zadnjeg cevastog elementa 28. Prednji cevasti element 24 ima suženje 25 u svom prednjem kraju u koje se može postaviti prirubnica 2 grla ampule 1. Na svom zadnjem kraju prednji cevasti element je izveden sa unutrašnjim navojem 28 u koji se može uvrnuti spoljni navoj 27 na zadnjem cevastom elementu 28. Kod svog zadnjeg kraja zadnji cevasti element 28 ima zatvoren zadnji zid 29 za koji je pričvrščen sa unutrašnje strane pričvrščen jedan nepokretan klip u zadnjem •cevastom elementu 28, pri Čemu taj klip'ima prečnik manji od unutrašnjeg prečnika ampule i pruža se prema ampuli 1.The embodiment shown in Fig. 6 comprises one holder in which container 1 can be fitted. The holder consists of two tubular elements that can be threaded, namely the front tubular element 24 and the rear tubular element 28. The front tubular element 24 has a narrowing 25 at its front end into which a flange 2 of the ampoule head can be fitted 1. At its rear end, the front tubular element is provided with an inner thread 28 into which an external thread 27 can be screwed onto the rear tubular element 28. At its rear end, the rear tubular element 28 has a closed rear wall 29 for which a fixed piston in the rear tubular element 28 is attached from the inside, wherein the pistons have a diameter smaller than the inner diameter of the ampoule and extend towards the ampoule 1.

Kod pripreme rastvora za ubrizgavanje/. zadnji cevasti element 28 se uvrne u prednji cevasti element 24, pri čemu je preporučljivo da se držač drži vertikalno tako da je suženo grlo 25 okrenuto naviše. Kada se zadnji cevasti element 28 uvrne u prednji cevasti element 24, nepokretni klip 30 pomeriče zadnji cevasti zid naviše i sabljati tečnost 11 u zadnjem proštoru 7. Tečnost če proizvoditi pritisak na prednji zid 8 tako da če se ovaj pomerati naviše do položaja tačno naspram spojncg kanala 12, u kom položaju tečnost 11 može mirno da protiče kroz spojni kanal 12 u prednji prostor 6 i da se meša sa medikamentom 10. Dok se dva cevasta elementa 24 i 28 zavrču jedan u drugi, vrši se veoma mirno proticanje tečnosti u prednji prostor 6 , koji je pri torne zatvoren membranom na prednjem kraju ampule. Kada tečnost utiče u prednji prostor 8, u njemu se javlja pritisak viši od atmosferskog, tako da se u gornjem kraju ampule obrazuje jedan mali džep 31 sabijenog gasa, što je prikazano na slici 7,-koja prikazuje držač u položaju kada su cevasti elementi 24 i 28 potpuno uvrnuti jedan u drugi, a sva tečnost se prelila u prednji prostor 6. Zahvalgujuči mirnom doticanju tečnosti u gornji prostor 6 obrazovanom pritisku višem od atmosferskog, spredeno je obrazovanje pene kod mešanja. Naravno, uredaj se može posle toga nekoliko puta okrenuti, ako je potrebno, da bi se medikament potpuno rastvorio u tečnosti.When preparing the injection solution. the rear tubular member 28 is screwed into the front tubular member 24, wherein it is advisable to hold the holder vertically so that the tapered throat 25 faces upwards. When the rear tubular element 28 is screwed into the front tubular element 24, the fixed piston 30 moves the rear tubular wall upwards and compresses the fluid 11 in the rear space 7. The fluid will exert pressure on the front wall 8 so that it moves upwards to the exact position opposite to the joint. channel 12, in which position the fluid 11 can flow smoothly through the connecting channel 12 into the anterior space 6 and mix with the medicament 10. While the two tubular elements 24 and 28 are screwed into each other, a very quiet fluid flow into the anterior space is performed 6, which is closed by a membrane at the anterior end of the ampoule. When the fluid enters the anterior space 8, a pressure higher than atmospheric pressure occurs therein, so that a small pocket 31 of compressed gas is formed in the upper end of the ampoule, shown in Figure 7, which shows the holder in the position when the tubular elements 24 and 28 completely screwed into each other, and all the liquid overflowed into the front space 6. Thanks to the quiet contact of the liquid in the upper space 6 with the formed pressure higher than atmospheric, the foam formation during mixing was prevented. Of course, the device can then be rotated several times, if necessary, to completely dissolve the drug in the liquid.

Kada se ispušta rastvor za ubrizgavanje pripremljen na ovaj način, uredaj se okrene u položaj prikazan na slici 8, pri čemu je prednji kraj ampule 1 okrenut naniže, tako da se gas u prednjem prostoru 6 ampule 1 sakuplja kod gornjeg kraja a ne u bližini membrane. Rastvor za ubrizgavanje se može uzimati pomoču cevčice, kanule 32 koja se uvodi kroz membranu ϊ prenosi do uobičajene brizgalice 33 za potkožno ubrizgavanje na poznat način.Lakše se izvlači rastvor za ubrizgavanje iz ampule 1 zahvaljujuči pritisku višem od atmosferskog koji deluje u prednjem prostoru 6 ampule, tako da če rastvor bar u početnom trenutku proticati pod sopstvenim pritiskom kroz cevčicu, kanulu 32 u brizgalicu 33 za davanje potkožnih injekcija.When the injection solution prepared in this manner is discharged, the apparatus rotates to the position shown in Figure 8, with the front end of ampoule 1 facing down so that gas in the front space 6 of ampoule 1 is collected at the upper end and not near the diaphragm . The injection solution can be taken with the aid of a tube, the cannula 32 which is introduced through the membrane ϊ transferred to the usual injection syringe 33 in a known manner. , so that at least initially the solution will flow under its own pressure through the tube, the cannula 32 into the syringe 33 for subcutaneous injection.

Kao što je ranije rečeno, druga varijanta izvodenja uredaja prema pronalasku prikazana je na slikama 9 do 11, ,pri čemu ima iste komponente kao i uredaj prikazan na slikama 6 i 7. Glavna razlika je u torne, što je uredaj prema slikama 9 do 11 projektovan da bude neposredno povezan sa jednom kanulom, cevčicom, kod suženog grla 25 prednjeg prstenastog elementa 24. Pored toga, zadnji zid 29 zadnjeg cevastog elementa 28 nije zatvoren več ima jedan sredšni otvor 3.4 kroz koji prolazi radna ' šipka 35. Radna šipka 35 je integralno povezana sa klipom 30 u zadnjem cevastom elementu, pri čemu klip nije povezan sa zadnjim cevastim elementom 28 več je ograničeno pcmerljiv u uzdužnom pravcu pomoču radne poluge 35. Kao i kod uredaja prikazanog na slikama 6 do 8, spoljni prečnik klipa 30 je manji od unutrašnjeg prečnika ampule 1, ali je istovremeno’ veči od prečnika otvora 34 u zadnjem zidu 29, tako da se klip 30 ne može izvuči iz zadnjeg cevastog elementa 28. Dva cevasta elementa 24 i 28 uvrču se· jedan u drugi iz položaja prikazanog na slici 9, u kome su komponente rastvora za ubrizgavanje potpuno razdvojene jedna od druge, na isti način kako je opisano u vezi sa prvom varijantom'izvodenja prema slikama 6 do 8, dok'se ne postigne potpuno mešanje i uredaj bude u položaju prikazanom na slici 10. U tom iAs stated earlier, another embodiment of the device according to the invention is shown in Figures 9 to 11, having the same components as the device shown in Figures 6 and 7. The main difference is in the towers, which is the device according to Figures 9 to 11 designed to be directly connected to one cannula, tube, at a tapered throat 25 of the front annular element 24. In addition, the rear wall 29 of the rear tubular element 28 is not closed but has a central opening 3.4 through which the working rod 35 passes. integrally connected to piston 30 in the rear tubular element, wherein the piston not connected to rear tubular element 28 is already limited in longitudinal direction by means of the operating lever 35. As with the device shown in Figures 6 to 8, the outer diameter of piston 30 is less than of the inner diameter of the ampoule 1, but at the same time 'larger than the diameter of the opening 34 in the rear wall 29, so that the piston 30 cannot be pulled out of the rear tubular member 28. Two tubular ele mints 24 and 28 are aligned with each other from the position shown in Figure 9, in which the components of the injection solution are completely separated from each other, in the same manner as described in connection with the first embodiment of embodiment 6 to 8, while 'complete mixing is not achieved and the device is in the position shown in Figure 10. In this and

• - * * - - “ ' λ. ‘ ~ ~ 5• - * * - - “'λ. '~ 5

-.N - ----- j-.N - ----- j

--A-’-- 1 »--A -'-- 1 »

položaju se stavlja poklopac 36 na suženo grlo 25 prednjeg cevastog elementa 24. Pored toga, kanula, cevčica, 32 je pričvrščena na poklopac 35, pri čemu probija membranu ampule 1 kada se poklopac stavlja na suženo grlo 25. To se vrši u vertikalnom položaju kada' je grlo 25 okrenuto naviše. Uredaj je spreman da se koristi kao brizgalica za davanje injekcija, pri čemu se to vrši pritiskom.na radnu šipku 35 tako da klip 30 pomera dva pomeri j iva zida 8 i 9 u napred u prednji prostor 6 u ampuli, tako da se prvo iz ampule uklanja gas, zatim se rastvor za ubrizgavanje ispušta kroz kanulu 32 na poznati način. ' ·the cover 36 is placed on the tapered throat 25 of the front tubular element 24. In addition, the cannula, tube 32 is attached to the cap 35, piercing the membrane of the ampoule 1 when the cap is placed on the tapered throat 25. This is done vertically when 'throat 25 is facing up. The device is ready to be used as a syringe for injection, which is done by pushing it on the working bar 35 so that the plunger 30 moves the two jivals of the wall 8 and 9 forward into the front space 6 in the ampoule, so that the ampoule removes the gas, then the injection solution is discharged through the conduit 32 in a known manner. '·

Jedan veoma praktičan i jednostavan instrument za pripremanje rastvora za ubrizgavanje dobija se uredajem prema pronalasku. Kao što je napred rečeno, uredaj obezbeduje veoma mirno i bezbedno mešanje komponenata rastvora za ubrizgavanje.A very practical and simple instrument for preparing injection solutions is provided by the apparatus of the invention. As stated above, the unit provides very quiet and safe mixing of the components of the injection solution.

Ako se mešanje vrši suviše brzo, rezultat je obrazovanje cestica i opalescenčija. Oba su izraz sakupljanja u grudve. Preporučljivo je da se uredaj izradi od plastične mase i u tom slučaju če cena uredaja biti veoma mala, pa se uredaj može koristiti jednokratno. Korka navoja na elementima nije kritičan, ali je preporučljivo da bude u granicama od 0,5 do 10 mm.If mixing is done too quickly, the result is the formation of particles and opalescence. Both are expressions of clumping. It is recommended that the device be made of plastic, in which case the price of the device will be very small, so the device can be used once. The thread pitch on the elements is not critical, but it is recommended that it be in the range of 0.5 to 10 mm.

Najpogodnije je da se uredaj prema pronalasku koristi za potkožne injekcije, ali su i drugi postupci za '.davanje Injekcija prema tekučoj medicinskoj praksi moguči,' kao, na primer, intramuskularna injekcija.It is most advantageous for the device according to the invention to be used for subcutaneous injections, but other procedures for 'administering injections according to current medical practice are possible,' such as, for example, intramuscular injection.

Kada se cilindrična ampula isprazni, uredaj za ubrizgavanje se odvrtanjem rastavi i izvadi se prazna kapsula. Mehanizam za doziranje se postavi na nulu i posle toga se uredaj ponovo može spremiti za ubrizgavanje, kao što je napred rečeno. Korisnik može lako da nosi sa sobom sklopljen i pripremljen uredaj da bi ga koristio u pogodnim trenucima.When the cylindrical ampoule is empty, the injection device is unscrewed and the empty capsule is removed. The dosing mechanism is reset to zero and the device can then be re-prepared for injection, as described above. It is easy for the user to carry with them a assembled and prepared device to use at convenient times.

Može biti neophodno da se zaštite osetljivi medikamenti, naročito tipa polipeptida, protiv mehaničkog dejstva kada su u rastvorenom obliku. Posebno kritični momenti su pretvaranje osušenog praška u rastvor, s jedne strane, a s druge strane, dalje rukovanje pripremljenim rastvorom. Ovo drugo če biti posebno važno kada se radi o preparatimaza veči broj doza kojima se mora rukovati više puta.It may be necessary to protect sensitive drugs, especially polypeptide types, against mechanical action when in dissolved form. Particularly critical moments are the conversion of the dried powder into a solution, on the one hand, and on the other, the further handling of the prepared solution. The latter will be especially important when it comes to preparations for multiple doses that must be repeatedly administered.

Koriščenje konvencionalnih pakovanja i brizgalica ne doprinosi zaštiti od mehaničkih naprezanja što, medutim, daje ovaj pronalazak. Uspostavljanje rastvora iz suvog praha pomoču pronalaska vrši se na veoma pazljiv način odreden konstrukcijom, tako da je medikament pošteden. Kako se rastvor priprena izvesnom natpritisku, u ovoj fazi je sprečeno penušanje i obrazovanje mehuriča. Dalje rukovanje pripremljenim rastvorom če takode biti veoma nežno prema pronalasku. Praktično je uklonjen sav vazduh koji je bio u dodiru sa ras.tvorom kada se uredaj za ubrizgavanje priprema da da prvu injekciju iz novo postavljene dvokomorne cilindrične ampule. Na taj način je izbegnuta medufaza koja kod rukovanja kontejnerom sa rastvorom dovodi do negativnih uticaja na osetlj iv medikament, pa se posle toga može rukovati kontejnerom bez posebnog vodenja računa o oset1jivosti rastvora.The use of conventional packs and syringes does not contribute to the protection against mechanical stresses, however, which the present invention provides. The establishment of the dry powder solution by the invention is carried out in a very careful manner by design, so that the medicament is spared. As the solution adheres to a certain overpressure, foaming and bubble formation are prevented at this stage. Further handling of the prepared solution will also be very gentle according to the invention. Practically all the air that was in contact with the solution was removed when the injection device was preparing to give the first injection from a newly installed two-chamber cylindrical ampoule. This avoids the interphase, which, when handling the solution container, has a negative effect on the sensitized drug, and can then be handled without the special sensitivity of the solution.

Zbog toga je moguče da se prikazanim pronalaskom pripremi jedan rastvor koji.se može koristiti duže ili krače vreme na blagi način, i da se transportuje pripremljeni rastvor bez snižavanja kvaliteta osetljivog medikamenta usled mehaničkog s' naprezanja. Zbog toga pronalazak omogučuje da i osetljivi medikamenti mogu biti na raspolaganju za komformno ambulantno lečenje.Therefore, it is possible to prepare one solution according to the present invention which can be used for a long or shorter time in a gentle way, and to transport the prepared solution without reducing the quality of the sensitive drug due to mechanical stress. Therefore, the invention makes it possible that sensitive medications may also be available for complex outpatient treatment.

Medikamenti koji se mogu koristiti u prikazanom uredaju mogu se sastojati od bilo koje supstance ili mešavina ‘e supstanci koje se koriste kod do sada poznatih dvokomornih ampula , ili su pogodne za ovu svrhu. Medutim, osetljive materije koje ne mogu biti uskladištene duže vremena u rastvoru i koje imaju tendenciju da se promene kada se rastvore posebno su pogodne. Primeri takvih supstanci su·razni polipeptid! kao što su hormoni i interferon. Utvrdeno je da j=e pronalazak posebno pogodan kod priprema i ubrizgavanja rastvora hormona rasta.Oni su veoma osetljivi i lako se modifikuju kada se od njih priprema rastvor. Koriščenjem u ovom slučaju 'prikazanog pronalaska, takav je uticaj znatno smanjen'. To je krajnje neočekivano i· stručnjaci ga nisu mogli predvideti.The medicaments that may be used in the apparatus shown may consist of any substance or mixture of substances used in the two-chamber ampoules known so far, or suitable for this purpose. However, sensitive substances which cannot be stored for a long time in solution and which tend to change when dissolved are particularly suitable. Examples of such substances are · various polypeptide! such as hormones and interferon. It has been found that the invention is particularly suitable for the preparation and injection of growth hormone solutions. They are very sensitive and easily modified when a solution is prepared from them. By using in the present case the 'invention disclosed, such influence is greatly reduced'. This is extremely unexpected and could not be foreseen by experts.

Suvi medikamenti se obično nalaze ujzamrzavanjem sušenom ili liofilizovanom stanju prepripreme rastvora za ubrizgavanje. Tečnost koja se koristi za rastvore obično se sastoji od vode kojoj se često dodaju agensi za podešavanje osmotskog pritiska, konzervansi i sl., a u skladu sa tekučom farmakološkom praksom. Takode je moguče da sama tečna faza može da sadrži rastvorene supstance koje mogu imati neko farmakološko dejstvo koje se potom mcže koristiti zajedno sa dejstvom agensa koji je kasnije rastvoren u tečnosti.Dry medicines are usually found in the freezing dried or lyophilized state of the preparation of the injection solution. The liquid used for the solutions usually consists of water to which osmotic pressure adjusting agents, preservatives, etc. are often added, and in accordance with current pharmacological practice. It is also possible that the liquid phase itself may contain dissolved substances which may have some pharmacological action which can then be used together with the action of the agent which is subsequently dissolved in the liquid.

Drugo je izvodenje kod koga se tečnost može sastojati od emulzije masti koja se može ubrizgavati, kao što je ona koja .je opisana u maeričkim patentnim spisima br. 4 .073 943 i 4 168 308. U ovom slučaju suva supstanca za ubrizgavanje sadrjedan. u vodi rastvorljiv ili hidrofilni agens koji se rastvara ili disperguje u vodenoj fazi emulzije u mešavini.Another embodiment is wherein the liquid may consist of an injectable grease emulsion, such as that described in the Maier patent documents no. 4 .073 943 and 4 168 308. In this case, the dry injection substance is present. a water-soluble or hydrophilic agent that dissolves or disperses in the aqueous phase of an emulsion in a mixture.

Uredaj za ubrizgavanje je načinjen od nekog pogodnog elementa kao što je metal,na primer nerdajuči Čelik ili legura aluminijuma ili neki pogodan plastičan materijal. Izbor metala je potpuno u delokrugu rada stručnjaka.The injection device is made of a suitable element such as metal, for example stainless steel or aluminum alloy or a suitable plastic material. The choice of metals is completely within the scope of work of the specialist.

Sem toga, potrebno je napomenuti da su postupak i uredaj prema pronalasku prikazani na crtežima i detaljno opisa-7 ni samo primeri, i da su moguča druga izvodenja takode moguča u okviru patentnih zahteva. ‘In addition, it should be noted that the process and apparatus of the invention are shown in the drawings and detailed descriptions-7 are not merely examples, and that other embodiments are also possible within the scope of the claims. '

Claims (4)

1. Naprava za vbrizgavanje injekcij, za pripravo raztopine substanc, občutljivih na degradacijo in za vbrizgavanje te raztopine, označena s tea, da vsebujeAn injection injection device for preparing a solution of substances susceptible to degradation and for injecting this solution, labeled with tea, to contain a) rezervoar (1) za komponente raztopine za vbrizgavanje, v katerem se komponente držijo ločeno ali se lahko z zunanjim vplivom združijo, da se zmešajo in raztopijo in ki je narejen kot cev (1), ki je hermetično zaprta na njenem sprednjem koncu s pomočjo membrane (3), ki se da predreti, pri kateri se v prostoru (6) med membrano, ki se da predreti in sprednjo pomično steno (8) nahajajo trdne komponente (10) raztopine za vbrizgavanje, medtem ko se v prostoru (7) med sprednjo pomično steno (8) in zadnjo pomično steno (9) nahaja tekoča komponenta (11) raztopine za vbrizgavanje in da je v cevasti steni izveden vezni kanal (12), nameščen tako, da lahko, kadar se zadnja pomična stena (9) premakne naprej, skupaj s tekočino (11) in s sprednjo pomično steno (8), tekočina teče ob sprednji pomični steni (8) in se zmeša s trdnimi komponentami (10) do dobivanja raztopine;a) a reservoir (1) for the components of the injection solution, in which the components are held separately or can be externally combined to mix and dissolve, and which is formed as a tube (1) sealed at its front end with by means of a permeable membrane (3), in which solid components (10) of the injection solution are located in the space (6) between the permeable membrane and the front movable wall (8), while in the space (7) ) between the front sliding wall (8) and the rear sliding wall (9) there is a liquid component (11) of the injection solution and a connecting channel (12) is arranged in the tubular wall so that when the rear sliding wall (9) ) moves forward, together with the fluid (11) and the front movable wall (8), the fluid flows along the front movable wall (8) and is mixed with the solid components (10) until a solution is obtained; b) držalo, v katerem se rezervoar (1) lahko pritrdi tako, da se komponente raztopine za vbrizgavanje lahko dovedejo v stik in zmeSajo in ki je narejen iz dveh cevastih elementov (13, 15), ki se lahko privijeta drug v drugega in obdajata rezervoar (1) tako, da je, ko se elementa spojita z navojem, sprednji konec rezervoarja z membrano (2), ki se da predreti, izpostavljen pri sprednjem koncu držala, da ga predre igla (17, 21) za injekcije in da je pri zadnjem koncu zadnja pomična stena (9) pomaknjena naprej skupaj s tekočino (11) in sprednjo pomično steno (8) tako, da se tekočina (11) prisili, da teče skozi vezni kanal (12) do prostora (6) s trdnimi komponentami, da se z istimi zmeša in tvori raztopino;b) a holder in which the reservoir (1) can be fixed so that the components of the injection solution can be brought into contact and mixed, and which is made of two tubular elements (13, 15) that can be screwed together and surrounded the reservoir (1) such that, when the elements are joined by a thread, the front end of the reservoir with the permeable membrane (2) is exposed at the front end of the holder to be punctured by the injection needle (17, 21) and at the rear end, the rear movable wall (9) is moved forward together with the fluid (11) and the front movable wall (8) by forcing the fluid (11) to flow through the connecting channel (12) to the space (6) with solid components to mix with them and form a solution; ε) držalo (18) za iglo (17) za injekcije, pripravljeno za namestitev na sprednji konec držala (13) rezervoarja tako, da se igla (21) lahko poveže s prostorom (6) rezervoarja skozi membrano (3), ki se da predreti; inε) injection needle holder (18) (17), ready to be mounted on the front end of the reservoir holder (13) so that the needle (21) can be connected to the reservoir space (6) through a diaphragm (3) predreti; and -σd) napravo (27) za doziranje, povezano z držalom (14) rezervoarja, z delovanjem katere se pomična stena (9) v rezervoarju primora, da se premakne naprej na kontroliran način, dajajoč pri tem določene doze raztopine za vbrizgavanje, pri Čemer se naprava (22) za doziranje namesti v nek začetni položaj zaradi doziranja, ko se z vijaki pričvrsti na držali (13, 14) rezervoarja.-σd) a dosing device (27) connected to a reservoir holder (14), by means of which the movable wall (9) in the reservoir reservoir is moved in a controlled manner, thereby delivering certain doses of the injection solution, wherein the dosing device (22) is positioned in a starting position for dosing when it is fastened to the retainers (13, 14) by the screws. 2. Naprava za vbrizgavanje injekcij za pripravo raztopine za vbrizgavanje zdravil iz substanc, občutljivih na razpadanje, označena s tes>, da se komponente raztopine za vbrizgavanje hranijo v rezervoarju (1), v katerem so komponente ločene, se pa lahko zberejo, da se zmešajo in raztopijo z zunanjim vplivom in ki je narejena kot cev, ki je na svojem sprednjem koncu (2) hermetično zaprta s pomočjo neke membrane, ki se da predreti, ki vsebuje prostor (6) med steno, ki se da predreti in neko sprednjo pomično steno (8), v katerem se nahajajo trdne komponente (10) raztopine za vbrizgavanje, medtem ko se v prostoru (7) pomično steno (8) in zadnjo pomično steno tekoče komponente raztopine za vbrizgavanje cevasti steni nek vezni kanal (12) nameščen tako, da lahko, ko se zadnja pomična stena (9) premakne naprej skupaj s tekočino (11) in s sprednjo pomično steno (8), tekočina (11) teCe ob sprednji pomični steni (8) in se zmeša s trdnimi komponentami (10) do dobivanja raztopine in da naprava obsega neko držalo (24, 28), v katerem se rezervoar lahko pritrdi tako, da se komponente (10, 11) raztopine za vbrizgavanje lahko dovedejo v stik in zmešajo in ki je narejeno iz dveh cevastih elementov (24, 28), ki se lahko privijeta drug v drugega, pri Čemer je sprednji konec (2) rezervoarja med sprednjo (9) nahajajo in ki ima v2. Injection device for the preparation of a solution for injection of drugs from susceptible substances, characterized by tes> that the components of the solution for injection are stored in a reservoir (1) in which the components are separated but can be collected in order to mixed and dissolved by external action, which is made as a tube sealed at its front end (2) by means of a permeable membrane containing a space (6) between the permeable wall and the anterior a movable wall (8) in which the solid components (10) of the injection solution are located, while in the space (7) the movable wall (8) and the rear movable wall of the liquid component of the injection solution a tubular wall (12) is installed so that when the rear movable wall (9) moves forward together with the fluid (11) and the front movable wall (8), the fluid (11) can flow along the front movable wall (8) and be mixed with solid components (10 ) until a solution is obtained and n that the device comprises a holder (24, 28) in which the reservoir can be fixed so that the components (10, 11) of the injection solution can be contacted and mixed and which is made of two tubular elements (24, 28) which can be screwed into each other, with the front end (2) of the tank between the front (9) being located and having in -u>(1) z membrano, ki se da predreti, izpostavljen pri sprednjem koncu (25) držala in da se pri zadnjemu koncu rezervoarja (1) zadnja cevasta stena (9) pomakne naprej skupaj s tekočino (11) in s sprednjo pomično steno (8) s pomočjo bata (30), nameščenega pri zadnjem koncu (28) držala, ki potiska zadnjo pomično steno (9) posode, rezervoarja (1) tako, da se tekočina (11) lahko spelje tako, da teče skozi vezni kanal (12) v prostor (6) trdnih komponent (10) in se s temi zmeša do dobivanja neke raztopine.-u> (1) with a permeable membrane exposed at the front end (25) of the holder and, at the rear end of the reservoir (1), the rear tubular wall (9) moves forward together with the fluid (11) and with the front movable the wall (8) by means of a piston (30) mounted at the rear end (28) of a holder that pushes the rear movable wall (9) of the container, of the reservoir (1) so that the fluid (11) can be discharged by flowing through the connecting channel (12) into the space (6) of the solid components (10) and mix with them until a solution is obtained. 3. Naprava v skladu z zahtevkom 2, označena s tem, da je bat (30) nepomično nameščen pri zadnjem koncu (28) držala in da je sprednji konec (24) držala izveden z odprtino, neposredno pred membrano, ki se da predreti v rezervoarju tako, da se neka cevCica, kanila, lahko vstavi skozi odprtino in membrano, ki se lahko pretrga zaradi izvlečenja pripravljene raztopine za vbrizgavanje za brizgalko (33) za dajanje i njeke i j .Apparatus according to claim 2, characterized in that the piston (30) is fixedly positioned at the rear end (28) of the holder and that the front end (24) of the holder is provided with an opening directly in front of the permeable membrane. the reservoir so that a tube, a cannula, can be inserted through an opening and a membrane that can be torn due to the extraction of the prepared injection solution for the syringe (33) for administration and care. 4. Naprava v skladu z zahtevkom 2, označena s tem, da je bat (30) izveden z delovno palico (35), ki se razteza skozi zadnjo steno (29) pri zadnjem koncu (28) držala in da je priključek na kanilo (32) nameščen pri sprednjem koncu (25) držala, ki se lahko prilagodi držaloma (24, 25) in nato prebode membrano rezervoarja (1).Apparatus according to claim 2, characterized in that the piston (30) is provided with a working rod (35) extending through the rear wall (29) at the rear end (28) of the holder and the attachment to the cannula (35). 32) mounted at the front end (25) of the retainer, which can be adapted to the retainers (24, 25) and then pierce the membrane of the reservoir (1).
SI8811284A 1987-07-02 1988-07-01 Device for injecting syringes SI8811284A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SE8702735A SE465065B (en) 1987-07-02 1987-07-02 Method and device for preparing and injecting an injection solution
SE8801405A SE464797B (en) 1988-04-15 1988-04-15 Device for preparing an injection solution
YU128488A YU46917B (en) 1987-07-02 1988-07-01 PROCEDURE AND DEVICE FOR PREPARATION AND INJECTION OF INJECTION AQUEOUS SOLUTION OF EMULSION OR SUSPENSION

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SI8811284A true SI8811284A (en) 1997-06-30

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HRP920949A2 (en) 1994-10-31

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