Syringe device with a dose limiting mechanism and an additional safety mechanism
Abstract
A syringe device for ejecting a dose of a medicament, the syringe device comprising: a dose limiting mechanism arranged to interact with a dose ejecting mechanism to prevent ejection of a dose exceeding a set dose, and a safety mechanism, which is arranged such with respect to the dose ejecting mechanism that, if the dose limiting mechanism fails, the safety mechanism prevents ejection of a dose exceeding the set dose.
Term
Term ended
Projected expiry passed 17 July 2026, 0.2 years ago.
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1 claim: 1 independent, 0 dependent
- 1Zastrzeżenia patentowe 1. Przyrząd do wstrzykiwania, wstrzykujący dawkę lekarstwa, który to przyrząd do wstrzykiwania zawiera:• obudowę • mechanizm wstrzykują cy dawkę zawierają cy: • element nastawiający dawkę, obrotowy względem obudowy tak, aby nastawiać dawkę przeznaczoną do wstrzykiwania, • tłoczysko usytuowane tak względem obudowy, że ruch postępowy tłoczyska w kierunku odsiebnym powoduje wstrzyknięcie dawki, • środki do przetworzenia ruchu obrotowego elementu nastawiającego dawkę na ruch postępowy tłoczyska;• ukł ad wspomagania wstrzykiwania, zapewniają cy siłę wstrzykującą, wspomagającą operatora przyrządu we wstrzykującym dawkę, aby zapobiec wstrzyknięciu dawki przekraczającej nastawioną dawkę;oraz • mechanizm bezpieczeń stwa, który jest tak usytuowany względem mechanizmu wstrzykującego dawkę, że jeżeli mechanizm ograniczający dawkę zawiedzie, mechanizm bezpieczeństwa zapobiega wstrzyknięciu dawki przekraczającej nastawioną dawkę. 2. Przyrząd do wstrzykiwania według zastrzeżenia 1, w którym obudowa tworzy kanał dla tłoczyska, zaś kanał ma gwintowaną powierzchnię wewnętrzną sprzęgającą się z gwintowaną powierzchnią zewnętrzną tłoczyska, przy czym tłoczysko jest usytuowane względem obudowy tak, że obrót tłoczyska względem obudowy powoduje, że tłoczysko jest przemieszczane ruchem postępowym względem obudowy. 3. Przyrząd do wstrzykiwania według dowolnego spośród zastrzeżeń 1 albo 2, w którym co najmniej jeden spośród mechanizmu ograniczającego dawkę oraz mechanizmu bezpieczeństwa jest przystosowany do ograniczania względnego ruchu obrotowego pomiędzy tłoczyskiem oraz obudową do obrotu odpowiadającego wstrzyknięciu nastawionej dawki. 4. Przyrząd do wstrzykiwania, wstrzykujący dawkę lekarstwa, który to przyrząd do wstrzykiwania zawiera: • obudowę • mechanizm wstrzykują cy dawkę zawierają cy: • element nastawiający dawkę, obrotowy względem obudowy tak, aby nastawiać dawkę przeznaczoną do wstrzykiwania, • tłoczysko usytuowane tak względem obudowy, że ruch postępowy tłoczyska w kierunku odsiebnym powoduje wstrzyknięcie dawki, • środki do przetworzenia ruchu obrotowego elementu nastawiającego dawkę na ruch postępowy tłoczyska;• mechanizm ograniczają cy dawkę , przystosowany do wzajemnego oddziaływania z mechanizmem wstrzykującym dawkę, aby zapobiec wstrzyknięciu dawki przekraczającej nastawioną dawkę, który to mechanizm ograniczający dawkę zawiera pierwszą powierzchnię zatrzymującą, przystosowaną do połączenia z odpowiednią drugą powierzchnią zatrzymującą obudowy, oraz w którym obrót elementu nastawiającego dawkę podczas nastawiania dawki powoduje, że pierwsza powierzchnia zatrzymująca odsuwa się od drugiej powierzchni zatrzymującej i w którym zapobiega się wstrzyknięciu dawki, gdy pierwsza powierzchnia zatrzymująca oprze się o drugą powierzchnię zatrzymującą;oraz • mechanizm bezpieczeń stwa, który jest tak usytuowany względem mechanizmu wstrzykującego dawkę, że jeżeli mechanizm ograniczający dawkę zawiedzie, mechanizm bezpieczeństwa zapobiega wstrzyknięciu dawki przekraczającej nastawioną dawkę. 5. Przyrząd do wstrzykiwania według zastrzeżenia 4, w którym element nastawiający dawkę zawiera pierwszą powierzchnię zatrzymującą. 6. Przyrząd do wstrzykiwania według zastrzeżenia 4, w którym element nastawiający dawkę jest połączony z cylindrem zawierającym pierwszą powierzchnię zatrzymującą, przy czym wymieniony cylinder jest przystosowany do wskazywania nastawionej dawki. 7. Przyrząd do wstrzykiwania według dowolnego spośród poprzednich zastrzeżeń, w którym mechanizm bezpieczeństwa zawiera: • ogranicznik tworzą cy kanał dla tł oczyska, przy czym kanał ogranicznika zawiera gwintowaną powierzchnię wewnętrzną w celu połączenia z gwintowaną powierzchnią zewnętrzną tłoczyska;oraz • czł on napę dzają cy tworzą cy kanał dla ogranicznika, przy czym człon jest utrzymywany obrotowo w w którym wzglę dny obrót pomię dzy czł onem napę dzają cym i tłoczyskiem podczas nastawiania dawki powoduje, że ogranicznik odsuwa się od położenia zatrzymania, w którym ogranicznik zapobiega wstrzykiwaniu dawki. 8. Przyrząd do wstrzykiwania według zastrzeżenia 1, w którym układ wspomagania wstrzykiwania zawiera sprężynę, która jest przystosowana do obracania członu napędzającego względem obudowy. 9. Przyrząd do wstrzykiwania według zastrzeżenia 8, w którym sprężyna jest wstępnie naprężona, gdy ogranicznik znajduje się w położeniu zatrzymania. NOVO NORDISK A/S Pełnomocnik: 1/1 ΕΡ 1 909 871 Β2 Fig. 1 77P25379PL00
26 paragraphs in 2 sections, as filed
[0001] The present invention relates to an injection device comprising a mechanism to prevent injection of a dose exceeding the set dose. In particular, the present invention relates to an injection device comprising two independent mechanisms to prevent injection of a dose exceeding the set dose.
BACKGROUND OF THE INVENTION [0002] When medications are to be injected into the human body, when the injected dose exceeds the set dose, it can have serious or even fatal consequences. Thus, it is important that the injection device contains means for limiting the injection to the set dose.
[0003] It is an object of the present invention to provide an injection device comprising means for preventing injection of a dose exceeding the set dose. Furthermore, since such means may fail, it is an object of the present invention to provide an injection device comprising a safety mechanism adapted to prevent injection of a dose exceeding the set dose if the preventive means fail.
SUMMARY OF THE INVENTION [0004] The present invention relates to an injection device for injecting a dose of a medicament according to claim 1 or claim 4.
[0005] An advantage of the present invention is that if the dose limiting mechanism does not limit the injected dose, the safety mechanism is activated and thus provides additional patient protection.
[0006] In one embodiment, the dose limiting mechanism and the safety mechanism are two independent mechanisms operating independently of each other.
[0007] In one embodiment, the two mechanisms are adapted to simultaneously prevent injection of a dose exceeding the set dose. In another embodiment, the safety mechanism is activated only if the dose limiting mechanism fails to prevent injection of a dose exceeding the set dose. In one embodiment, the two mechanisms are set up so that even if the dose limiting mechanism fails, the safety mechanism will be injected immediately the dose will not exceed dose setting.
the security mechanism will be activated. A slightly higher dose means that the dose change is too small to have serious or fatal consequences.
[0008] The housing may form a channel for the piston rod, and the channel may have a threaded internal surface engaging the threaded outer surface of the piston rod, the piston rod may be positioned relative to the housing so that the rotation of the piston rod relative to the housing causes the piston rod to be displaced with respect to the housing .
[0009] In one embodiment, at least one of the dose limiting mechanism and the safety mechanism is adapted to limit the relative rotational movement between the piston rod and the housing for rotation corresponding to injection of a set dose. This could be the case when the piston rod comprises a threaded outer surface adapted to be connected to the threaded inner surface of the housing. Accordingly, the rotatable locking of the piston rod (relative to the housing) blocks the translational movement of the piston rod relative to the housing.
[0010] The dose limiting mechanism may include at least one first retaining surface adapted to be connected to at least one respective second retaining surface of the housing. Furthermore, rotation of the dose setting member during dose setting causes the first retaining surface to move away from the second retaining surface, and rotation during injection of the dose may cause the first and second surfaces to move toward each other. In addition, dose injection is prevented when the first retaining surface rests against the second retaining surface. The dose setting member may include at least one first retaining surface.
Alternatively or in addition, the dose setting member may be connected to a cylinder comprising a first retaining surface, said cylinder may be adapted to indicate a set dose. The first and second retaining surfaces may be substantially flat surfaces that may extend in a direction parallel to the axial direction of the device. Alternatively, the retaining surfaces may extend in a plane not transverse to the axial direction, such as a plane perpendicular to the axial direction.
[0011] In one embodiment, the safety mechanism comprises: a stop forming a passage for the piston rod, the stop passage comprising a threaded inner surface for connection with the threaded outer surface of the piston rod; and a driving member forming a passage for the limiter, the driving member being rotatably maintained relative to the limiter, and further the driving member is connected to the dose setting member such that rotation of the dose setting member during dose setting causes the driving member to rotate; wherein the relative rotation between the drive member and the piston rod during dose setting causes the stop to move away from the stop position and the stop to prevent injection of the dose.
[0012] In one embodiment, the injection device is adapted to prevent a dose setting that exceeds the amount of medicine present in the container of the injection device. In such embodiments, the piston rod may include a dose end retaining surface adapted to be connected to the respective surface of the stop when the set dose corresponds to the amount of medicine in the container of the injection device. Therefore, in such embodiments, the restrictor performs two functions, the first function is to prevent the dose setting exceeding the amount of medicine remaining in the container, and the second function is the safety function adapted to prevent injection of a dose exceeding the set dose.
[0013] Furthermore, the injection device may comprise an injection aid system providing an injection force to assist the device operator in pushing the plunger in said distal direction to inject a set dose. The injection support system may be adapted to push the plunger distally to inject the dose without user assistance when the user has started the injection.
[0014] The injection support system may include a spring, such as a torsion spring, which is adapted to rotate the drive member relative to the housing. The spring can be preloaded when the stop is in the stopped position. Especially when the spring is pre-stressed, the redundant safety system of the present invention is advantageous because inadvertently relaxing the pre-stressed spring can cause the piston rod to rotate (and therefore move progressively) which corresponds to a lethal dose such as 100 IU (international units) of insulin.
[0015] The invention will now be described in more detail with reference to Fig. 1, which discloses an injection device according to the present invention.
[0016] Fig. 1 shows an injection device 2 comprising a housing 4 and a piston rod 6. The injection device 2 also includes a dose setting member 8 and a drive member 10, which in the figure are combined into a single unit. The injection device further comprises a scaled drum 12 showing the set dose through a window 14. The scaled drum 12 has a threaded outer surface 15 adapted to be connected to a corresponding threaded inner surface 16 of the housing. The scaled drum 12 is kept rotatable relative to the drive member 10 through the groove-projection 18. The scaled drum 12 includes a first retaining surface 17 adapted to be connected to the second retaining surface 19 of the housing. The first retaining surface 17 and the second retaining surface 19 constitute the dose limiting mechanism 21. The first retaining surface is moved away from the second retaining surface 19 during dose setting and they are brought together during injection of the dose. When the two surfaces abut against each other, the device is protected against injection of medicine.
[0017] The injection device comprises an injection aid system in the form of a pre-tensioned torsion spring 23 extending between the drive member 10 and the proximal part 20 of the housing. Accordingly, when the dose setting member 8 is rotated to set the dose, the spring is tensioned even more.
[0018] The piston rod 6 comprises a threaded outer surface 22 adapted to be connected to a corresponding threaded inner surface of the housing 24 and, accordingly, rotation of the piston rod relative to the housing causes the piston rod to translate in a translational motion relative to the housing. The threaded outer surface 22 of the piston rod also engages with the threaded inner surface 26 of the stop 28, which in Fig. 1 is located in the stop position where the lower surface 30 of the stopper engages with the upper surface 32 of the piston rod guide 34. Lower surface 30 and upper surface 32 constitute a safety mechanism 31. There may be an air gap between the lower surface 30 and the upper surface 32, which allows the limiter and piston rod to rotate by an angle corresponding to a slight increase in the injected dose, e.g. 3 IU (international units) of insulin if the dose limiting mechanism 21 fails when injecting the dose.
[0019] Furthermore, the upper surface 36 of the "end of content" of the stop 28 is adapted to contact the lower surface 38 of the "end of content" of the end portion 40 of the T-shaped piston rod. The surfaces of the "end of content" are adapted to contact when the set dose corresponds to the amount of medicine remaining in the tank (not shown) of the instrument. Therefore, the contact of the "end of content" surface prevents setting a dose that exceeds the amount of medicine remaining in the reservoir. It is understood that the distance between the "end of content" surfaces thus corresponds to the amount of medicine remaining in the reservoir.
[0020] Furthermore, the upper surface 11 of the drum 12 may be adapted to engage the lower surface 13 of the housing when the maximum dose is set. The maximum dose is the highest dose that can be adjusted for each injection (assuming that the injection device contains the required amount of medicine). The maximum dose does not correspond to the "end-of-content" dose, which refers to the remaining amount of medicine in the instrument. Therefore, as long as the remaining amount of medicine in the device is greater than the maximum dose, the "end of content" surfaces will not touch each other during dose setting, whereas when the remaining amount of medicine in the device is less than the maximum dose, the maximum dose surfaces will not touch. with each other during dose setting because the "end of content" surfaces prevent further rotation.
[0021] The stop 28 and the drive member 10 are locked against mutual rotation by means of a groove-projection connection 42. Thus, when the piston rod is blocked from rotation relative to the housing, mutual rotation between the drive member 8 and the piston rod 6 causes the stop to slide away from the stop position and towards the T-shaped end portion 40 (i.e. at the top of the figure). The piston rod is locked against rotation relative to the housing when the piston rod guide 34 is locked against rotation against the housing (not shown) when the piston rod guide 34 and the piston rod are blocked against relative rotation due to the groove-projection connection 44.
[0022] The driving member 12 and the piston rod guide 34 are interconnected by a bi-directional ratchet mechanism 46 comprising at least one first retaining element 48 formed by the driving member 12 and at least one second retaining element 50 formed by the piston rod guide 34. The bi-directional ratchet mechanism is adapted to allow relative obstructive movement between the drive member 12 and the piston rod guide 34 during dose setting and to ensure that the rotational movement of the drive member during injection of the dose is transmitted to the piston guide guide 34.
[0023] The use of the device is as follows. Initially, the piston rod guide is locked against rotation relative to the housing. The dose setting member is then rotated, which causes the drive member and the scaled drum to rotate and the pre-stressed spring tensions even more. At the same time, the stop moves towards the T-shaped end portion. If the user attempts to set a dose that exceeds the amount of medicine in the instrument, the limiter rests against the T-shaped end portion, and therefore a larger dose cannot be set. The dose is injected by removing the rotation lock between the piston rod guide 34 and the housing, where the tensioned spring forces the drive member to rotate. The rotating driving member forces the piston rod guide to rotate, which again forces the piston rod to rotate. Due to the 44 groove-projection connection, and the threaded connection between the piston rod and the housing, the rotating piston rod is forced to move forward and in this way the medicine is ejected from the device.
NOVO NORDISK A / S
Proxy:
EP 1 909 871 B2
Contents2
33 members in 14 offices
Priority claims8
| Document | Office | Kind | Date |
|---|---|---|---|
| 05016286 | European Patent Office (EPO) | A | |
| 05016286 | European Patent Office (EPO) | A | |
| 06762643 | European Patent Office (EPO) | A | |
| 2006007006 | European Patent Office (EPO) | W | |
| 2006007006 | European Patent Office (EPO) | W | |
| EP20050016286 | – | – | – |
| EP20060762643 | – | – | – |
| WO2006EP07006 | – | – | – |
Members33
| Document | Office | Kind | |
|---|---|---|---|
| AU2006278928A1 | Australia | A1 | |
| CA2616248A1 | Canada | A1 | |
| WO2007017053A1 | World Intellectual Property Organization (WIPO) | A1 | |
| EP1909871A1 | European Patent Office (EPO) | A1 | |
| CN101227942A | China | A | |
| US2008234634A1 | United States of America | A1 | |
| JP2009502274A | Japan | A | |
| RU2008101973A | Russian Federation | A | |
| EP1909871B1 | European Patent Office (EPO) | B1 | |
| AT447992T | Austria | T | |
| ATE447992T1 | Austria | T1 | |
| DE602006010396D1 | Germany | D1 | |
| DK1909871T3 | Denmark | T3 | |
| ES2336827T3 | Spain | T3 | |
| PL1909871T3 | Poland | T3 | |
| CN101227942B | China | B | |
| RU2407557C2 | Russian Federation | C2 | |
| BRPI0613926A2 | Brazil | A2 | |
| AU2006278928B2 | Australia | B2 | |
| JP4937258B2 | Japan | B2 | |
| EP1909871B2 | European Patent Office (EPO) | B2 | |
| ES2336827T5 | Spain | T5 | |
| DK1909871T4 | Denmark | T4 | |
| PL1909871T5This record | Poland | T5 | |
| CA2616248C | Canada | C | |
| BRPI0613926B1 | Brazil | B1 | |
| US10220155B2 | United States of America | B2 | |
| US2019192783A1 | United States of America | A1 | |
| BRPI0613926B8 | Brazil | B8 | |
| US11097063B2 | United States of America | B2 | |
| US2021346606A1 | United States of America | A1 | |
| US12268854B2 | United States of America | B2 | |
| US2025195784A1 | United States of America | A1 |
Numbers
- Publication, DOCDB
- 1909871
- Publication, EPODOC
- PL1909871T
- Application
- 762643
- Application, DOCDB
- 06762643
- Application, EPODOC
- PL20060762643T
Titles2
- English
- SYRINGE DEVICE WITH A DOSE LIMITING MECHANISM AND AN ADDITIONAL SAFETY MECHANISM
- Polish
- Przyrząd do wstrzykiwania z mechanizmem ograniczającym dawkę oraz dodatkowym mechanizmem bezpieczeństwa
Classification
- CPC, 8
- A61M5/31583
- A61M5/20
- A61M5/31541
- A61M5/31553
- A61M5/31558
- A61M5/31561
- A61M5/31573
- A61M5/31593
- IPC, 1
- A61M5 315