HRP920767A2

HRP920767A2 - Automatic two-chamber injector

Info

Publication number: HRP920767A2
Application number: HR920767A
Authority: HR
Inventors: Carl-Axel Hook; Nils Billy Nilson; Kjell Ingemar Wellenstam
Original assignee: Astra Tech Ab
Priority date: 1987-04-14
Filing date: 1992-10-01
Publication date: 1995-06-30
Also published as: HRP920767B1; SI8810741B; SI8810741A

Description

Oblast izuma Field of invention

Izum se odnosi na automatsku dvokomornu špricu za injekcije koja obuhvaća jedno cilindrično šuplje tijelo koje ima prednji kraj s dijelom za prihvaćanje igle za injekcije i zadnji kraj s kliznim klipom, pri čemu je dio za prihvaćanje igle hermetički zatvoren prije upotrebe. The invention relates to an automatic two-chamber injection syringe comprising a single cylindrical hollow body having a front end with an injection needle receiving portion and a rear end with a sliding piston, the needle receiving portion being hermetically sealed prior to use.

Izum se također odnosi na postupak aktiviranja dvokomorne šprice za injekcije i na kapsulu za dvokomornu dizalicu. The invention also relates to a method of activating a two-chamber syringe for injections and a capsule for a two-chamber crane.

Osnove izuma Basics of invention

Automatske šprice za injekcije su razvijene naročito za upotrebu od strane osoba koje iz nekog razloga moraju ubrizgati neku otopinu u vlastito tijelo u nekom trenutku koji se ne može unaprijed odrediti, kao, na primjer, vojnici koji su u ratu izloženi nervnim plinovima. Ove su šprice za injekcije uskladištene godinama, a zatim su još češće izložene teškim uvjetima tijekom ponekad dužeg vremena kad su kod potencijalnog korisnika. Kada se automatska šprica za injekcije konačno mora koristiti, ona mora raditi vrlo pouzdano ako se mora vršiti davanje injekcije. Prema tome, postavljaju se posebni uvjeti za automatske šprice za injekcije spomenute vrste u pogledu pouzdanosti i jednakosti, kako u pogledu rukovanja tako i u pogledu djelovanja. Automatic injection syringes were developed especially for use by persons who for some reason must inject a solution into their own body at some time that cannot be determined in advance, such as, for example, soldiers who are exposed to nerve gases in war. These injection syringes are stored for years, and then more often exposed to harsh conditions during the sometimes long time they are with the potential user. When the automatic injection syringe finally has to be used, it has to work very reliably if the injection is to be given. Therefore, special requirements are set for automatic injection syringes of the mentioned type in terms of reliability and uniformity, both in handling and in operation.

U posljednje vrijeme razvijeni su protuotrovi koji se koriste protiv nervnih plinova, pri čemu su ti protuplinovi stabilni u vidu praha, ali teško održavaju u otopini, naročito tijekom dugih perioda skladištenja, koji su normalni s tim u vezi. Zbog toga se javlja potreba za automatske šprice za injekcije koje su jednostavne, brze i pouzdane i koje su projektirane tako da se mogu uskladištiti dvije tvari odvojene jedna od druge tijekom dugog vremenskog perioda, i koje će se zatim moći lako pomiješati prije upotrebe. Recently, antidotes have been developed that are used against nerve gases, and these antidotes are stable in powder form, but difficult to maintain in solution, especially during long periods of storage, which are normal in this regard. Therefore, there is a need for automatic injection syringes which are simple, fast and reliable and which are designed so that two substances can be stored separately from each other for a long period of time, and which can then be easily mixed before use.

Nekoliko različitih dvokomornih šprica za injekcije je od ranije poznato: Several different two-chamber injection syringes are known from earlier:

U američkom patentnom spisu br. 4,529,403 prikazana je jedna automatska dvokomorna šprica za injekcije s jednom ampulom postavljenom između dvije igle za injekcije i klipa. Ampula je izvedena s jednim ili više klipova od savitljivog materijala kao što je guma, koja drži otopine za ubrizgavanje međusobno razdvojene. U prednjem dijelu ampule izvedeni su bočno kanali ili profili koji omogućuju da otopine za injekcije postavljeni otraga prođu pored klipa ili klipova. In US patent file no. No. 4,529,403 shows one automatic two-chamber injection syringe with one ampoule positioned between two injection needles and a plunger. The ampoule is made with one or more pistons made of a flexible material such as rubber, which keeps the injection solutions separated from each other. In the front part of the ampoule, there are lateral channels or profiles that allow the solutions for injections placed at the back to pass past the piston or pistons.

U američkom patentnom spisu br. 4,413,991 opisan je jedan drugi sustav za automatsku dvokomornu špricu za injekcije, kod koje jedan tzv. klip potiskuje iglu za injekcije kroz dvije odvojene komore za različite otopine. Igla za injekcije izvedena je sa bočnim otvorima koji međusobno povezuju obje komore tijekom ubrizgavanja. In US patent file no. 4,413,991 another system for an automatic two-chamber injection syringe is described, where a so-called the plunger pushes the injection needle through two separate chambers for different solutions. The injection needle is designed with side openings that connect both chambers during injection.

U američkom patentnom spisu br. 4,202,314 opisan je jedan sustav s dvije komore čiji se sadržaji miješaju a zatim automatski ubrizgavaju. Postavljena su dva pogonska sustava, jedan za miješanje i drugi za ubrizgavanje. Igla za ubrizgavanje postavljena je unutar kapsule. In US patent file no. 4,202,314 describes a system with two chambers whose contents are mixed and then automatically injected. Two drive systems were installed, one for mixing and the other for injection. The injection needle is placed inside the capsule.

Kod izvođenja opisanog u američkom patentnom spisu br. 4,214,583, posebne komore su postavljene koncentrično s jednim cilindričnim zidom. Da bi se pomiješao sadržaj komora, cilindrični zid se pomoću navoja podiže, čime se ostvaruje miješanje. Kod ovog izvođenja igla za ubrizgavanje je u početku također postavljena u kapsulu. In the embodiment described in US patent document no. 4,214,583, special chambers are placed concentrically with one cylindrical wall. In order to mix the contents of the chambers, the cylindrical wall is raised by means of a thread, which achieves mixing. In this embodiment, the injection needle is also initially placed in the capsule.

Poznate automatske dvokomorne šprice za injekcije imaju više nedostataka: Known automatic two-chamber injection syringes have several disadvantages:

Korištenje polimernih materijala za razdvajanje otopina od praška, ili jedne otopine od druge, znači da je propuštanje tekućine u manjoj ili većoj mjeri neizbježno u tijeku dužih perioda skladištenja. The use of polymeric materials to separate solutions from powders, or one solution from another, means that leakage of liquid to a lesser or greater extent is inevitable during longer periods of storage.

Miješanje razdvojenih ljekovitih tvari je nepotpuno, a u nekim slučajevima može i potpuno izostati. Postavljanje igle za ubrizgavanje unutar kapsule u neku otopinu povlači veliki rizik da će ista korodirati u tijeku drugih perioda držanja na skladištu. The mixing of the separated medicinal substances is incomplete, and in some cases it can be completely absent. Placing the injection needle inside the capsule in a solution entails a high risk that it will corrode during other storage periods.

Komplicirana operacija da bi se ostvarilo dovoljno miješanje tvari, sa uz to povezanim nedostatkom kontrole operacije, stvara opasnost da se šprica za injekcije koristi na pogrešan način, što može dovesti do izostanka ljekovitog djelovanja, pa u najgorem slučaju i do rizika da dođe do nesreće. The complicated operation to achieve sufficient mixing of the substances, with the associated lack of control of the operation, creates the danger that the injection syringe is used in the wrong way, which can lead to a lack of medicinal effect and, in the worst case, to the risk of an accident.

Nemogućnost zamjenjive ugradnje kapsule uz očuvanje danog stupnja sterilnosti. Impossibility of replaceable installation of the capsule while preserving the given degree of sterility.

Osnovna koncepcija izuma Basic concept of the invention

Cilj je prikazanog izuma da se riješe navedeni problemi projektiranjem jedne automatske dvokomorne šprice za injekcije, sa jednom kapsulom u kojoj su dvije tvari međusobno razdvojene, tako da je omogućeno dugo i sigurno skladištenje, i kod koje se može postići potpuno miješanje tih tvari. Rad je brz i jednostavan i nemoguće je da se šprica za injekcije pogrešno koristi zahvaljujući konstrukciji šprice za injekcije. The aim of the presented invention is to solve the mentioned problems by designing an automatic two-chamber syringe for injections, with one capsule in which two substances are separated from each other, so that long and safe storage is possible, and in which complete mixing of these substances can be achieved. The operation is quick and easy and it is impossible for the injection syringe to be used incorrectly thanks to the construction of the injection syringe.

Posebno, izum se može koristiti i za miješanje dviju ili više ljekovitih tvari neposredno prije upotrebe, pri čemu je jedna od materija neka tekućina, a druga/druge u tekućem ili praškastom obliku, poslije čega se vrši ubrizgavanje dobivene otopine. Naprava omogućuje da se medicinski preparati uskladište odvojeno i pod sterilnim uvjetima, da se miješaju neposredno prije ubrizgavanja i da se svježa i potpuno pomiješana otopina ubrizga u tjelesno tkivo. In particular, the invention can be used to mix two or more medicinal substances immediately before use, where one of the substances is a liquid, and the other/others are in liquid or powder form, after which the resulting solution is injected. The device allows medicinal preparations to be stored separately and under sterile conditions, to be mixed immediately before injection, and to inject a fresh and fully mixed solution into body tissue.

Jedna automatska dvokomorna šprica za injekcije, kako je opisana u uvodnom dijelu i prema izumu, karakteristična je po tome što njeno cilindrično šuplje tijelo obuhvaća dvije komore razdvojene jednom nepropusnom membranom, pri čemu se ta membrana probija kada se jedan klip i cilindrično šuplje tijelo pomiču jedno prema drugom. An automatic two-chamber syringe for injections, as described in the introductory part and according to the invention, is characterized in that its cylindrical hollow body comprises two chambers separated by an impermeable membrane, this membrane being pierced when a piston and a cylindrical hollow body move together according to the other.

Druga pogodna svojstva izuma bit će sagledana iz slijedećeg opisa izvođenja i iz priloženih patentnih zahtjeva. Other suitable properties of the invention will be seen from the following description of the implementation and from the attached patent claims.

Prema izumu, prednost se postiže kada membrana koja razdvaja ove dvije komore jednu od druge, sprečava proticanje tekućine, čime ostvaruje povećanu trajnost sadržaja kapsule. Postavljanje igle za ubrizgavanje izvan samog cilindričnog šupljeg tijela, bez dodira s otopinom za ubrizgavanje, također pridonosi povećanju trajnosti, budući da je izbjegnuta opasnost od korozije. According to the invention, the advantage is achieved when the membrane that separates these two chambers from one another prevents the flow of liquid, thus achieving increased durability of the contents of the capsule. Placing the injection needle outside the cylindrical hollow body itself, without contact with the injection solution, also contributes to increased durability, since the risk of corrosion is avoided.

Konstrukcija prednjeg poklopca i njeno sudjelovanje s cilindričnim šupljim tijelom, čini da je rad naprave potpuno kontroliran kao proces, tako da se ostvaruje potpuno miješanje, a potom aktiviranje i ubrizgavanje. Konstrukcija naprave omogućuje da se samo jedna po jedna operacija izvodi po željenim fazama, što dovodi do jednostavnog, i iznad svega, sigurnog funkcioniranja. The construction of the front cover and its participation with the cylindrical hollow body, makes the operation of the device fully controlled as a process, so that complete mixing is achieved, and then activation and injection. The construction of the device allows that only one operation at a time is performed according to the desired phases, which leads to simple, and above all, safe functioning.

Fino motoričko djelovanje pomoću pokreta rukom potrebno je da se zakrene prednji poklopac. To je jedno dodatno sigurnosno svojstvo, budući da je nemoguće nenamjerno aktiviranje izazvano uticajem oblika u vodu, na primjer, potiska ili pritiska, ili zbog toga što bi neki dio zapeo za neki susjedni predmet. Fine motor action using hand movements is required to rotate the front cover. This is an additional safety feature, since accidental activation caused by the impact of the shape into the water, for example, thrust or pressure, or due to a part getting stuck on an adjacent object, is impossible.

Obrtni prednji poklopac konstruiran je tako da se može okretati samo u jednom smjeru, što znači da postoji mogućnost kontrole ako je šprica za injekcije aktivirana prije vremena i ako je faza miješanja aktivirana mnogo prije no što će se šprica za injekcije upotrijebiti. The rotatable front cover is designed so that it can only be turned in one direction, which means that there is a possibility of control if the injection syringe is activated prematurely and if the mixing phase is activated long before the injection syringe is to be used.

Dvokomorna šprica za injekcije prema izumu izrađuje se od jednostavnih materijala i jednostavne je konstrukcije, što znači da je pogodna za upotrebu kao šprice za injekcije za jednokratnu upotrebu. Cilindrično šuplje tijelo zajedno s iglom za ubrizgavanje čini jednu odvojivu, posebnu jedinicu, koja stvara dodatne oblasti primjene i dodatne prednosti. Poslije izvršenog ubrizgavanja prednji poklopac se može skinuti i upotrijebljena kapsula se može zamijeniti novom. Pogonska jedinica se puni ponovo i postavlja se prednji poklopac, poslije čega je šprica za injekcije opet spremna za upotrebu. Kako kapsula s njenim sadržajima često ima manju trajnost od mehaničke jedinice, velika je prednost da se može kapsula skladištiti posebno u tijeku dužeg vremena, na primjer kod primjene za vojne svrhe. Ako za uskladištene šprice za injekcije nije bilo potrebe da se koriste u tijeku vijeka trajanja kapsule, kapsula se može zamijeniti novom što je mnogo povoljnije od situacija kada se mora zamijeniti cjelokupna dvokomorna šprica za injekcije. Ovaj sustav također daje mogućnost da se bira između različitih ljekovitih materija u alternativnim kapsulama, što znači da postoji mogućnost prilagođavanja različitim očekivanim situacijama. The double-chamber injection syringe according to the invention is made of simple materials and has a simple construction, which means that it is suitable for use as a single-use injection syringe. The cylindrical hollow body together with the injection needle forms a separate, special unit, which creates additional areas of application and additional advantages. After the injection, the front cover can be removed and the used capsule can be replaced with a new one. The drive unit is refilled and the front cover is installed, after which the injection syringe is ready for use again. As the capsule with its contents often has less durability than the mechanical unit, it is a great advantage to be able to store the capsule especially over a long period of time, for example when used for military purposes. If the stored injection syringes have not needed to be used during the life of the capsule, the capsule can be replaced with a new one, which is much more convenient than situations where the entire two-chamber injection syringe has to be replaced. This system also gives the possibility to choose between different medicinal substances in alternative capsules, which means that there is a possibility to adapt to different expected situations.

Dvokomorna šprica za injekcije prema izumu prvenstveno je namijenjena za primjenu u vojsci, ali je također pogodna za primjenu u drugim oblastima humane medicine, kao i u veterinarskoj medicini. The two-chamber injection syringe according to the invention is primarily intended for use in the military, but is also suitable for use in other areas of human medicine, as well as in veterinary medicine.

Kratak opis priloženih crteža Brief description of the attached drawings

Jedno izvođenje dvokomorne šprice za injekcije prema izumu i njegove modifikacije bit će detaljnije opisani u slijedećem tekstu s pozivom na priložene crteže, gdje: One embodiment of the two-chamber injection syringe according to the invention and its modifications will be described in more detail in the following text with reference to the attached drawings, where:

- slika 1 prikazuje aksijalni presjek prvog izvođenja dvokomorne šprice za injekcije prije upotrebe, - figure 1 shows an axial section of the first version of the two-chamber injection syringe before use,

- slike 2a i 2b prikazuju bočnu projekciju i aksijalni presjek vodeće čahure prema slici 1, - figures 2a and 2b show the side projection and axial section of the guide sleeve according to figure 1,

- slike 3a i 3b prikazuju bočnu projekciju i aksijalni presjek cilindričnog šupljeg tijela prema slici 1, - figures 3a and 3b show the side projection and axial section of the cylindrical hollow body according to figure 1,

- slika 4 prikazuje, u uvećanom mjerilu, komoru za prašak, - picture 4 shows, on an enlarged scale, the powder chamber,

- slika 5 prikazuje bočnu projekciju nosača opruge, - figure 5 shows the side projection of the spring support,

- slike 6a i 6b prikazuju bočnu projekciju i aksijalni presjek prednjeg poklopca - Figures 6a and 6b show the side projection and axial section of the front cover

- slika 7 prikazuje aksijalni presjek dugog izvođenja dvokomorne šprice za injekcije prije upotrebe, - figure 7 shows an axial section of a long version of a two-chamber injection syringe before use,

- slika 8 prikazuje aksijalni presjek drugog izvođenja vodeće čahure, - figure 8 shows the axial section of the second embodiment of the guide sleeve,

- slike 9a i 9b prikazuju bočnu projekciju i aksijalni presjek cilindričnog šupljeg tijela prema slici 7, - figures 9a and 9b show the side projection and axial section of the cylindrical hollow body according to figure 7,

- slike 10a i 10b prikazuju bočnu projekciju i aksijalni presjek klipa prema slici 7, - figures 10a and 10b show the side projection and axial section of the piston according to figure 7,

- slike 10a do 11d prikazuju dijelove dvokomorne šprice za injekcije prema slici 1 u tijeku raznih faza aktiviranja, pri čemu slika 11a prikazuje početnu situaciju, slika 11b prikazuje situaciju miješanja, slika 11 c prikazuje početak ubrizgavanja i slika 11d prikazuje završno ubrizgavanje, - figures 10a to 11d show parts of the two-chamber syringe for injections according to figure 1 during various stages of activation, with figure 11a showing the initial situation, figure 11b showing the mixing situation, figure 11c showing the start of injection and figure 11d showing the final injection,

- slika 12 prikazuje aksijalni presjek zadnjeg poklopca u položaju kada je opruga otpuštena, - figure 12 shows the axial section of the rear cover in the position when the spring is released,

- slika 13 predstavlja shematski prikaz unutarnje površine prednjeg poklopca, pri čemu je poklopac razderan i razvijen u ravnini papira. - Figure 13 is a schematic representation of the inner surface of the front cover, where the cover is torn and unfolded in the plane of the paper.

Detaljan opis preporučljivih izvođenja izuma Detailed description of preferred embodiments of the invention

Izvođenje dvokomorne šprice za injekcije prikazane na slikama od 1 do 6 obuhvaća jedno tijelo koje se sastoji od čahure (1) za zabravljivanje pomoću navoja. Čahura (1) za zabravljivanje je konstruirana s jednim prstenastim žlijebom (3) i razrezana je u više uzdužnih krakova (4), preporučljivo četiri, koji na svojim krajevima imaju na stranu usmjerene ispuste (5). Unutrašnjost krajnjih dijelova krakova (4) projektirana je s radijalnim dijelovima (5) prirubnice koji čine sjedište za pogonsku oprugu (7), postavljenu u čahuri (1) za zabravjivanje. Vodeća čahura (2), prikazana na slikama 2a i 2b, ima dva dijametralno suprotna uzdužna žlijeba (8) van područja navoja, koji se završavaju graničnicima (9). Drugi kraj vodeće čahure (2) izveden je sa više vanjskih klinova (10). The embodiment of the two-chamber injection syringe shown in Figures 1 to 6 comprises a single body consisting of a sleeve (1) for locking by means of a thread. The locking bushing (1) is constructed with one annular groove (3) and is cut into several longitudinal arms (4), preferably four, which have lateral outlets (5) at their ends. The inside of the end parts of the arms (4) is designed with radial parts (5) of the flange that form the seat for the drive spring (7), placed in the bushing (1) for locking. The guide sleeve (2), shown in figures 2a and 2b, has two diametrically opposed longitudinal grooves (8) outside the thread area, which end with stops (9). The other end of the guide sleeve (2) is made with several external pins (10).

Cilindrično šuplje tijelo(11), prikazano na slikama 3a i 32b, pomično je postavljena u vodećoj čahuri (2) pomoću dva klizača (12), postavljena izvana i dijametalno suprotno na cilindrično šuplje tijelo, i kreću se u uzdužnim žljebovima (8) vodeće čahure. Klizač (12) projektiran je sa otvorom za kuglicu (13) i također ima jedan elastični jezičak (14). Cilindrično šuplje tijelo(11) hermetički je zatvoreno na prednjem kraju da bi oblikovalo prijemni dio (15) u kome je klizno pomično postavljen držač (16) igle sa šupljom iglom (17) za ubrizgavanje. Prijemni dio (15) ima jedan otvor postavljen u sredini u koji se umeće zadnji dio igle (17) za ubrizgavanje, i na čijem je dnu postavljena membrana (18) koja se može probušiti. Prednji dio igle (17) za ubrizgavanje je obuhvaćen zaštitnim mjehom (19) kako bi se igla za ubrizgavanje održala sterilna. The cylindrical hollow body (11), shown in figures 3a and 32b, is movably positioned in the guide sleeve (2) by means of two sliders (12), placed outside and diametrically opposed to the cylindrical hollow body, and moving in the longitudinal grooves (8) of the guide bushings. The slider (12) is designed with a hole for the ball (13) and also has one elastic tab (14). The cylindrical hollow body (11) is hermetically sealed at the front end to form a receiving part (15) in which a needle holder (16) with a hollow needle (17) for injection is slidably mounted. The receiving part (15) has an opening placed in the middle into which the last part of the injection needle (17) is inserted, and at the bottom of which is placed a membrane (18) that can be pierced. The front part of the injection needle (17) is covered with a protective bladder (19) to keep the injection needle sterile.

Cilindrično šuplje tijelo (11) s iglom za ubrizgavanje i vodeća čahura (2) su obuhvaćene prednjim poklopcem (20) koji je okretljiv na vodećoj čahuri (2) i koji je prikazan na slikama 6a i 6b. Prednji poklopac je izveden s vanjskim rebrima kako bi se osiguralo sigurno hvatanje poklopca. Više unutarnjih ispusta (21) za zabravljivanje prilagođeno je za zajedničko djelovanje s klinovima (10) vodeće čahure. Prednji poklopac je zatvoren na prednjem kraju, pri čemu je oblikovan središnji dio (22), čija je debljina zida znatno manja od debljine zida drugih dijelova. Kod zadnjeg dijela prednjeg poklopca oblikovano je jedno produženje (23) n oko polovini obima poklopca. Dio prednjeg poklopca koji obuhvaća vodeću čahuru (2) ima dvije unutarnje klizne vođice (45), pomaknute 180° jedna u odnosu na drugu, a koje djeluju zajedno sa klizačima (12) cilindričnog šupljeg tijela. U tom dijelu prednjeg poklopca izvedeno je više dodatnih žljebova koji će kasnije biti detaljnije opisani. The cylindrical hollow body (11) with the injection needle and the guide sleeve (2) are covered by a front cover (20) which is rotatable on the guide sleeve (2) and which is shown in Figures 6a and 6b. The front cover is made with external ribs to ensure a secure grip of the cover. A plurality of internal locking lugs (21) are adapted to cooperate with the pins (10) of the guide sleeve. The front cover is closed at the front end, whereby a central part (22) is formed, the wall thickness of which is significantly smaller than the wall thickness of the other parts. At the rear part of the front cover, one extension (23) is formed about half the circumference of the cover. The part of the front cover that includes the guide sleeve (2) has two internal sliding guides (45), offset by 180° relative to each other, which work together with the slides (12) of the cylindrical hollow body. In that part of the front cover, there are several additional grooves that will be described in more detail later.

Unutar cilindričnog šupljeg tijela(11), na kraju suprotnom od prijemnog dijela, izvedena je komora (24), za prašak prema slici (4). Vanjska površina izvedena je s kružnim žlijebom (25) za prihvaćanje kuglice (13) klizača (12) cilindričnog šupljeg tijela. Jedan dodatni prstenasti žlijeb postavljen je da prihvati brtvu. Unutarnji upor (26) čini sjedište klipa (27) koji se do izvjesne ograničene mjere može pomicati u komori (24) za prašak, pri čemu je taj klip izveden s brtvom prema unutarnjoj površini komore za prašak. Aluminijska membrana (23) s plastičnom oblogom zavarena je kod unutarnjeg kraja komore (24) i čini, zajedno s klipom (27), komoru (29) za jednu od sadržanih tvari. U cilindričnom šupljem tijelu(11) sačinjena je druga komora (30) s druge strane aluminijske membrane (29), pri čemu ta druga komora sadrži drugu tvar. Inside the cylindrical hollow body (11), at the opposite end of the receiving part, there is a chamber (24) for the powder according to figure (4). The outer surface is made with a circular groove (25) for accepting the ball (13) of the slide (12) of the cylindrical hollow body. One additional annular groove is provided to accept the gasket. The internal support (26) forms the seat of the piston (27) which can be moved to a certain limited extent in the powder chamber (24), whereby this piston is designed with a seal against the inner surface of the powder chamber. An aluminum membrane (23) with a plastic coating is welded at the inner end of the chamber (24) and forms, together with the piston (27), a chamber (29) for one of the contained substances. A second chamber (30) is formed in the cylindrical hollow body (11) on the other side of the aluminum membrane (29), and this second chamber contains another substance.

Na nebrtvljenom, otvorenom kraju klipa (27) postavljen je na oslonom prstenu (33) nosač (31) opruge, također prikazan i na slici 5. Nosač opruge obuhvaća jedan konusan dio (32) za centriranje postavljen s prednje strane na prstenu za oslonac, pri čemu je taj konusni dio umetnut u otvoreni kraj klipa. Suprotni kraj nosača opruge ima glavu (34) za zabrtvljivanje, pri čemu se između dva kraja nalazi jedan središnji dio s prirubnicom. Glava (34) za zabravljivanje spreže se sa ispustima za zabravljivanje u dijelovima (6) prirubnice na krakovima čahure za zabravljivanje radi sabijanja opruge (7) postavljene oko nosača (31) opruge, između dijelova (6) prirubnice i prstena za oslonac. On the non-sealed, open end of the piston (27), a spring support (31) is mounted on the support ring (33), also shown in Figure 5. The spring support includes a conical centering part (32) placed on the front side of the support ring, wherein this conical part is inserted into the open end of the piston. The opposite end of the spring support has a head (34) for sealing, with a central flanged section between the two ends. The locking head (34) mates with the locking outlets in the flange sections (6) on the arms of the locking sleeve to compress the spring (7) positioned around the spring carrier (31), between the flange sections (6) and the support ring.

Čahura (1) za zabravljivanje je obuhvaćena pomičnim zadnjim poklopcem (35) koji se pruža do ruba prstenastog žlijeba (3) čahure za zabravljivanje. Suprotni kraj zadnjeg poklopca je zatvoren dugmetom (36) za aktiviranje, koje ima cilindričnu vodeću površinu (37), koja se pruža u zadnji poklopac. Zadnji poklopac je proširen sa unutarnje strane u području cilindrične vodeće prirubnice (37), kako bi se oblikovao kružni unutarnji vodeći kanal (38) na ekstremnom kraju zadnjeg poklopca. The locking sleeve (1) is enclosed by a movable rear cover (35) which extends to the edge of the annular groove (3) of the locking sleeve. The opposite end of the back cover is closed by an actuation button (36), which has a cylindrical guide surface (37), which extends into the back cover. The rear cover is widened from the inside in the region of the cylindrical guide flange (37), to form a circular inner guide channel (38) at the extreme end of the rear cover.

Elastični prsten (39) za osiguranje postavljen je u cilindrični žlijeb (3) čahure za zabravljivanje, a između zadnjeg poklopca (35) i prednjeg poklopca (20), pri čemu taj prsten ima dužinu po obimu koja odgovara oko 220ş. Jedan tanki prsten (40) postavljen je u žlijeb (3) za osiguranje, pri čemu su prsten (40) i prsten (39) za osiguranje međusobno povezani jednim slobodnim čvorom (nije prikazan), čija je svrha da poveže prsten za osiguranje s špricom za injekcije, čak nakon što se odvoji od žlijeba. The elastic ring (39) for securing is placed in the cylindrical groove (3) of the locking sleeve, and between the rear cover (35) and the front cover (20), this ring having a circumferential length corresponding to about 220ş. A thin ring (40) is placed in the groove (3) for securing, whereby the ring (40) and the securing ring (39) are connected to each other by a free knot (not shown), the purpose of which is to connect the securing ring to the syringe for injections, even after it is separated from the chute.

Na slikama od 7 do 10 prikazano je drugo izvođenje jedne dvokomorne šprice za injekcije, koja se od izvođenja prema slikama od 1 do 6 razlikuje po jednom alternativnom izvođenju vodeće čahure (2), cilindričnog šupljeg tijela (11) i klipa (27). Vodeća čahura (2), prikazana na slici 8, razlikuje se od izvođenja sa slike 2 samo alternativnim izvođenjem uzdužnog žlijeba (8). Da bi se spriječilo nenamjerno pomicanje cilindričnog šupljeg tijela (11) i komore (24) za prašak prema klipu (27), čime bi se izazvao prijevremeni proces miješanja, uzdužni žlijeb (8) izveden je s drugim graničnikom (48) koji djeluje zajedno s klizačem (12), kako bi se zaustvio klizač (12) u položaju koji odgovara početnoj točki kose klizne vođice. Elastični jezičak (49) postavljen je duž jedne od uzdužnih strana uzdužnog žlijeba (8) nasuprot graničniku (48). kada treba početi faza miješanja, zakošena vođica (45) potiskuje zaobljene bridove klizača (12) silom koja potiskuje elastični jezičak (49) prema van, uslijed čega može klizač (12) proći pokraj graničnika (48), poslije čega dolazi do miješanja. Sa svake strane dva klizača (12) cilindričnog šupljeg tijela izvedeni su prorezi (41) (vidjeti slike 9a i 9b), kako bi se omogućilo elastično pomicanje pripadajućeg klizača (12). Sferični ispusti (42), izvedeni su na unutarnjoj površini vođice radi sprezanja prstenastim žljebovima (25) komore (24) za prašak. Uz to, prednji dio cilindričnog šupljeg tijela izveden je s kružnim cilindričnim kanalom (43) koji obuhvaća prijemni dio (15). Klip (25) prikazan na slikama 10a i 10b, izveden je s jednim ili više probojaca (44), koji se umeću u cilindrični kanal (43) cilindričnog dijela (11) koji obuhvaća prijemni dio kada je klip (27) u njegovom istegnutom položaju. Probojnici (44) su na klip postavljeni da mehanički probiju membranu (28) kada se cilindrično šuplje tijelo i komora za prašak pomaknu prema klipu. Figures 7 to 10 show another embodiment of a two-chamber injection syringe, which differs from the embodiment according to Figures 1 to 6 by an alternative embodiment of the guide sleeve (2), cylindrical hollow body (11) and piston (27). The guide sleeve (2), shown in Figure 8, differs from the version in Figure 2 only by the alternative execution of the longitudinal groove (8). In order to prevent the unintentional movement of the cylindrical hollow body (11) and the powder chamber (24) towards the piston (27), which would cause a premature mixing process, the longitudinal groove (8) is made with another stop (48) which works together with with the slide (12), in order to stop the slide (12) in the position corresponding to the starting point of the inclined slide guide. The elastic tongue (49) is placed along one of the longitudinal sides of the longitudinal groove (8) opposite the stop (48). when the mixing phase is to start, the inclined guide (45) pushes the rounded edges of the slider (12) with a force that pushes the elastic tab (49) outwards, as a result of which the slider (12) can pass past the stop (48), after which mixing occurs. On each side of the two sliders (12) of the cylindrical hollow body, slits (41) are made (see figures 9a and 9b), in order to enable elastic movement of the corresponding slider (12). Spherical outlets (42) are made on the inner surface of the guide to connect the powder chamber (24) with annular grooves (25). In addition, the front part of the cylindrical hollow body is made with a circular cylindrical channel (43) that includes the receiving part (15). The piston (25) shown in figures 10a and 10b is made with one or more punches (44), which are inserted into the cylindrical channel (43) of the cylindrical part (11) that includes the receiving part when the piston (27) is in its extended position . Punches (44) are mounted on the piston to mechanically pierce the diaphragm (28) when the cylindrical hollow body and powder chamber are moved toward the piston.

Funkcioniranje izuma Operation of the invention

Rad dvokomorne šprice za injekcije obuhvaća dvije faze, jednu fazu miješanja i fazu otpuštanja i ubrizgavanja koje će biti detaljno prikazane s pozivom na slike 11a do 11d, koje prikazuju dijelove dvokomorne šprice za injekcije u različitim položajima. The operation of the dual-chamber injection syringe comprises two phases, a mixing phase and a release and injection phase which will be detailed with reference to Figures 11a to 11d, which show parts of the dual-chamber injection syringe in various positions.

Slika 11a prikazuje špricu za injekcije u njenom početnom položaju, u kome sadrži tvar u tekućem obliku u komori (30), razdvojenu od tvari u obliku praška u drugoj komori (29) aluminijskom membranom (28). U početnoj fazi produžetak (23) prednjeg poklopca pokriva prsten (39) za osiguranje tako da je nemoguće prije vremena osloboditi prsten za osiguranje. Da bi se pomiješale obje tvari, prednji poklopac (20) se okrene, zbog čega klizači (12) klize duž kosih kliznih površina (45), tako da bivaju potisnuti unatrag u uzdužne proreze (8). Kuglice (13)/klizači (12) pritisnuti su na kružne žljebove (25) komore za prašak unutarnjom površinom prednjeg poklopca (20), što dovodi do toga da su i cilindrično kućište (11) i komora (24) za prašak potisnuti unatrag zajedno s klizačima (12). Na taj način je komora za prašak pomaknuta prema klipu (27) pri čemu raste pritisak u komori (29) do te mjere da prska aluminijska membrana (28), alternativno, probojac probija aluminijsku membranu (28). Figure 11a shows the injection syringe in its initial position, in which it contains a substance in liquid form in a chamber (30), separated from a substance in powder form in another chamber (29) by an aluminum membrane (28). In the initial phase, the extension (23) of the front cover covers the securing ring (39) so that it is impossible to release the securing ring prematurely. To mix both substances, the front cover (20) is turned, causing the sliders (12) to slide along the inclined sliding surfaces (45), so that they are pushed back into the longitudinal slots (8). The balls (13)/sliders (12) are pressed against the circular grooves (25) of the powder chamber by the inner surface of the front cover (20), causing both the cylindrical housing (11) and the powder chamber (24) to be pushed back together with sliders (12). In this way, the powder chamber is moved towards the piston (27), whereby the pressure in the chamber (29) increases to the extent that the aluminum membrane (28) sprays, alternatively, the punch pierces the aluminum membrane (28).

Na slici 11b prikazan je položaj kod koga je probijena aluminijska membrana i prašak se istiskuje iz njegove komore (29) kako bi se pomiješao s tekućinom. Kada klizač (12) dostigne kraj kose klizne vođice (45), cijela kapsula (1, 16, 17) i komora (24) za prašak pomiču se unatrag do položaja u kojem su krajnje površine klipa (27) i komore (24) za prašak postavljene u istoj zajedničkoj ravnini, a prsten za oslonac (33) nosača opruge naliježe na unutarnji upor (26) komore za prašak. Ovime je faza miješanja završena, ali može biti dopunjena, ukoliko je potrebno, miješanje u šprici za injekcije. Figure 11b shows the position where the aluminum membrane is pierced and the powder is forced out of its chamber (29) to mix with the liquid. When the slide (12) reaches the end of the inclined slide guide (45), the entire capsule (1, 16, 17) and the powder chamber (24) move back to the position where the end surfaces of the piston (27) and the powder chamber (24) are powder placed in the same common plane, and the support ring (33) of the spring support rests on the inner stop (26) of the powder chamber. This completes the mixing phase, but it can be supplemented, if necessary, by mixing in a syringe for injections.

Nakon faze miješanja, prednji poklopac je u takvom relativnom položaju okretanja, da produžetak (23) u vanjskom kraju pokriva otvor prstena (39) za osiguranje istovremeno kada su klizači (12) smješteni u uzdužnim žljebovima D (vidjeti sliku 3), u prednjem poklopcu, što omogućuje da se kuglice (13)/sferni ispusti (42) oslobode iz žljebova (25) po obimu komore za prašak. Dvokomorna šprica za injekcije je spremna za fazu ubrizgavanja koja započinje odvajanjem prstena (39) za osiguranje od cilindričnog žlijeba (3) čahure za zabravljivanje, poslije čega se šprica za injekcije postavlja na dio tijela u koje treba izvršiti davanje injekcije. After the mixing phase, the front cover is in such a relative turning position that the extension (23) at the outer end covers the opening of the securing ring (39) at the same time when the sliders (12) are located in the longitudinal grooves D (see figure 3), in the front cover , which allows the balls (13)/spherical outlets (42) to be released from the grooves (25) around the circumference of the powder chamber. The double-chamber injection syringe is ready for the injection phase, which begins by separating the securing ring (39) from the cylindrical groove (3) of the locking sleeve, after which the injection syringe is placed on the part of the body to be injected.

Dugme (36) za aktiviranje i zadnji poklopac (35) se pritisnu i pomaknu prema prednjem poklopcu, što je moguće jer je uklonjen prsten (39) za osiguranje. Pomicanjem zadnjeg poklopca u odnosu na čahuru za zabravljivanje postiže se otpuštanje opruge (7) na način prikazan na slici 12. U stranu usmjereni ispusti (5) čahure za zabravljivanje uvode se u vodeći kanal (38) pri čemu se dijelovi prirubnice elastičnih krakova šire i glava (34) za zabravljivanje nosača opruge, a time i pogonska opruga (27) otpuštaju. The activation button (36) and the back cover (35) are pressed and moved towards the front cover, which is possible because the securing ring (39) has been removed. By moving the rear cover in relation to the locking sleeve, the release of the spring (7) is achieved in the manner shown in Figure 12. The lateral discharges (5) of the locking sleeves are introduced into the guide channel (38), whereby the parts of the flange of the elastic arms expand and the head (34) for locking the spring carrier, and thus the drive spring (27) are released.

Na slici 11c prikazana je dvokomorna šprica za injekcije u položaju u kojem je započelo ubrizgavanje. Opruga (7) potiskuje prema naprijed komoru (24) s praškom zajedno s klipom (27). Kako se kuglice (13)/klizači (12) mogu potisnuti u žljebove u prednjem poklopcu, komora za prašak se odvaja od cilindričnog šupljeg tijela (11). Klip pritišće tekućinu koja hidraulički prenosi pritisak na cilindrično šuplje tijelo koje se potiskuje prema naprijed, uslijed čega igla (17) za ubrizgavanje pribija tanki materijal u središnjem dijelu (22) prednjeg poklopca. Kada se zaštitni mijeh (19) sabije, držač (16) igle potisnut je u prijemni dio (15), a zadnji dio igle (17) za ubrizgavanje probijam membranu (18). U ovom položaju je uspostavljena veza između pomiješanog rastvora i igle za ubrizgavanje, i ubrizgavanje započinje i nastavlja se u tijelu zajedničkog kretanja prema naprijed komore (24) za prašak i klipa (27). Figure 11c shows the two-chamber injection syringe in the position where the injection has started. The spring (7) pushes the powder chamber (24) forward together with the piston (27). As the balls (13)/sliders (12) can be pushed into the grooves in the front cover, the powder chamber is separated from the cylindrical hollow body (11). The piston presses fluid which hydraulically transmits the pressure to the cylindrical hollow body which is pushed forward, causing the injection needle (17) to impinge the thin material in the center part (22) of the front cover. When the protective bellows (19) is compressed, the needle holder (16) is pushed into the receiving part (15), and the last part of the injection needle (17) pierces the membrane (18). In this position, the connection between the mixed solution and the injection needle is established, and the injection begins and continues in the body of the joint forward movement of the powder chamber (24) and the piston (27).

Na slici 11d prikazan je položaj kada je ubrizgavanje završeno a cilindrično šuplje tijelo (11), komora (24) za prašak i klip (27) su svi pomaknuti u pripadajuće krajnje položaje silom opruge, a sva pomiješana otopina je ubrizgana u pacijente. Figure 11d shows the position when the injection is completed and the cylindrical hollow body (11), the powder chamber (24) and the piston (27) are all moved to their respective end positions by spring force, and all the mixed solution is injected into the patients.

Slika 13 predstavlja shematski prikaz unutarnje površine prednjeg poklopca (20) i način klizanja klizača (12, 12’) duž spomenute unutarnje površine kada se prednji poklopac zakrene. Kada je prednji poklopac postavljen, on se vodi preko vodeće čahure tako da klizač (12) (odgovara drugom klizaču (12’) pomakom za 180ş) bude pomaknut duž žlijeba A, a ispusti (12) za zabravljivanje prolaze kroz vanjske ispuste (10). Svi žljebovi su izvedeni s oštrim rubovima u “pravcu nerotiranja” radi zajedničkog djelovanja elastičnog jezička (14) klizača koji zapada iz oštrog ruba i time sprečava zakretanje prednjeg poklopca (20) u pogrešnom smjeru. Potom se prednji poklopac zakrene za još jednu fazu sve dok klizač (12) ne dostigne žlijeb B. Žlijeb B predstavlja polazni položaj za rad dvokomorne šprice za injekcije. Ako se prednji poklopac zakrene, klizač (12) se tada pomakne duž zakošene klizne vođice (45), a okretanje se prekida kada klizač (12) nalegne na unutarnji rub (46). Klizač je postavljen u žlijeb D koji je žlijeb u kome je postavljen klizač (12) u fazi oslobađanja i ubrizgavanja, pri čemu taj žlijeb ima dubinu koja će omogućiti da se kuglica (13)/sferični ispust (42) oslobode iz kružnog žlijeba (25) komore za prašak. U tijeku faze ubrizgavanja, klizač (12) se pomiče duž žlijeba D u kome će dostići svoj krajnji položaj ako se dvokomorna šprica za injekcije neće ponovo koristiti. Za skidanje prednjeg poklopca, poklopac se zakreće još za jedan stupanj, tako da klizač prolazi ispod ruba (46) i žlijeb A’, pri čemu se pomiče 180° u odnosu na žlijeb A. U tom položaju se može skinuti prednji poklopac za vodeće čahure budući da se ispusti za zabravljivanje odvajaju od ispusta (10). Figure 13 presents a schematic view of the inner surface of the front cover (20) and the way the sliders (12, 12') slide along said inner surface when the front cover is rotated. When the front cover is installed, it is guided over the guide bushing so that the slide (12) (corresponding to the second slide (12') by a 180° offset) is moved along the groove A, and the tabs (12) for locking pass through the external tabs (10). . All the grooves are made with sharp edges in the "direction of non-rotation" due to the joint action of the elastic tongue (14) of the slide that falls from the sharp edge and thus prevents the rotation of the front cover (20) in the wrong direction. Then the front cover is rotated for another stage until the slider (12) reaches the groove B. The groove B represents the starting position for the operation of the two-chamber injection syringe. If the front cover is rotated, the slider (12) then moves along the beveled slide guide (45), and the rotation is stopped when the slider (12) rests on the inner edge (46). The slider is placed in the groove D which is the groove in which the slider (12) is placed during the release and injection phase, this groove having a depth that will allow the ball (13)/spherical outlet (42) to be released from the circular groove (25) ) powder chambers. During the injection phase, the slide (12) moves along the groove D in which it will reach its end position if the two-chamber injection syringe will not be used again. To remove the front cover, the cover is rotated one more degree, so that the slide passes under the edge (46) and the groove A', moving 180° in relation to the groove A. In this position, the front cover for the guide bushings can be removed since the locking outlets are separated from the outlet (10).

Izum ni u kom slučaju nije ograničen na naprijed opisana izvođenja te je nekoliko modifikacija izuma moguće unutar opsega patentnih zahtjeva. Tako, na primjer, membrana, koja razdvaja komore jednu od druge, može biti od drugog nepropusnog materijala. Broj i konstrukcija probojaca za mehaničko probijanje membrane također se može mijenjati. The invention is in no way limited to the previously described embodiments, and several modifications of the invention are possible within the scope of the patent claims. So, for example, the membrane, which separates the chambers from each other, can be made of another impermeable material. The number and design of the punches for mechanical piercing of the membrane can also be changed.

Claims

1. An automatic two-chamber injector, comprising one cylindrical body (11) with a receiving part (15) for the injection needle (17) and the other end with a sliding piston (27), whereby the receiving part (15) is hermetically sealed before use, characterized in that the cylindrical body (11) comprises two chambers (29, 30), separated from each other by an impermeable membrane (28), whereby this membrane is adapted to be destroyed when the piston (27) and the cylindrical body (11) move towards each other another.

2. Automatic two-chamber injector according to claim 1, characterized in that the membrane (28) is adapted to be broken by mechanical action or pressure difference between the chambers (29, 30).

3. Automatic two-chamber injector according to claim 2, characterized by the fact that the front cover (20) rotatably works together with the cylindrical body (11), that the piston (27) can move to a limited extent in the powder chamber (24), made in the second end of the cylindrical body, that one of said chambers (29) is placed in said powder chamber (24), and that the cylindrical body (11) is adapted to move the powder chamber (24) in the direction of the piston (27) by turning the front cover ( 20).

4. Automatic injector according to claim 3, characterized in that the powder chamber (24) can be moved in the cylindrical body (11) in one rotating position of the front cover (20), and is locked in the cylindrical body (11) for all other rotating positions positions of the front cover (20).

5. An automatic two-chamber injector according to claim 3, characterized in that inclined sliding guides are placed on the inner surface of the front cover (20) to cooperate with the sliders (12) on the cylindrical body (11) in order to move the cylindrical body (11) when it is rotated front cover (20).

6. Automatic two-chamber injector according to claim 5, characterized in that the slide (12) contains one outlet (13, 42) adapted to cooperate with the groove (25) in the powder chamber (24) in order to lock the chamber (24) in the cylindrical body (11).

7. Automatic two-chamber injector according to claim 6, characterized in that at least one groove (D) is placed in the inner surface of the front cover (20) in order to accept parts of the associated slide (12) in one of the angular positions of the front cover (20) in order to enable separation chamber (24) from the cylindrical body (11).

8. Automatic two-chamber syringe according to claim 7, characterized in that the injection needle (17) is movably placed in the receiving part (15) and is sterilely covered by a protective bladder (19) before use, while the receiving part (15) is hermetically separated from the cylindrical body (11) by means of a membrane (18) which is pierced when the needle (17) moves in the receiving part (15).

9. Automatic two-chamber injector according to claim 8, characterized in that the cylindrical body (11) with the powder chamber (24) and the piston (27) forms a replaceable unit together with the injection needle (17) which is covered by the protective bellows (19).

10. Automatic two-compartment injector according to claim 9, characterized in that one or more punches (44) are placed on the piston (27) in order to pierce the membrane (28), wherein the punch (44) is located inside the cylindrical channel (43) placed in the bottom of the cylindrical body (11) when the piston (27) is placed in its final extended position.

11. Method for mixing and injecting a solution using a two-piece automatic syringe, indicated by the fact that the front cover (20) rotates, which leads to the tearing of the membrane (28) between the two chambers (29, 30) in the cylindrical body (11) and mixing of the contents of the chambers (29, 30), after which one retaining ring is removed to allow relative movement between the front cover (20) and the rear cover (35) to release the drive spring (7) which pushes the solution through the injection needle (17) using piston (27).

12. The method according to claim 11, characterized in that the rotation of the front cover (20) moves the cylindrical body (11) towards the piston (27) in order to tear the membrane.

13. A capsule for a two-chamber syringe, characterized in that it comprises a cylindrical body (11) with two chambers (29, 30) separated by an impermeable membrane (28), the membrane (28) being adapted to break when the piston (27) is moved in the aforementioned cylindrical body (11).

14. Capsule according to claim 13, characterized in that the cylindrical body (11) includes a receiving part (15) for the injection needle at one end of the cylindrical body (11), wherein this receiving part is hermetically sealed before use, and the needle (17 ) is movably placed in the receiving part (15) and is sterilely covered with a protective bladder (19) before use.