The present invention relates to the field of medical syringes. Especially, the present invention concerns a lockable syringe for safely dispensing a drug, said lockable syringe having a locking mechanism configured to be attached to the proximal end of the syringe body. The locking mechanism of the invention comprises (i) a plunger having at least one distal plate and a rod with visual means for marking an unlock position; and (ii) a locking ring, free in its rotation, about the longitudinal axis of the syringe body, said locking ring having at least one visual indicator on its outer surface, and said locking ring having means for blocking the plunger stroke in a locked position.
Syringes suitable for dispensing a drug or a pharmaceutical composition to a subject are particularly interesting for medical applications.
A medical syringe classically comprises a syringe body with a tip, a piston inside the syringe body configured to be in contact with the drug or the pharmaceutical composition pre-filled in said syringe body, and a plunger configured to slidably move the piston inside the syringe body, along the longitudinal axis of said syringe body.
In general, when a practitioner must dispense a drug to a subject from a prefilled syringe, he only has to push the plunger of the syringe for slidably moving the piston inside the syringe body and thus, delivering the drug.
However, it may happen that the practitioner is in a medical environment where several syringes pre-filled with different drugs are at his disposal. In this case, the risk of using the wrong pre-filled syringe is increased.
In order to limit the risk of medical error, there is a need for providing safer pre-filled syringes. Especially, there is a need for making the practitioner more aware of the use of the chosen pre-filled syringe by forcing him to check that the drug to be administered to the patient corresponds to that prefilled in the syringe. Furthermore, the locking mechanism of the pre-filled syringe has to be ergonomic and simple to be used by the operator so that checking step of the drug inside the pre-filled syringe is fast and easy to implement. There is also a need for providing pre-filled lockable syringes by a low-cost and industrializable process.
For this purpose, a subject of the invention is a lockable syringe for dispensing a drug, comprising:
wherein:
In a conventional manner, within the frame of the invention, the terms “proximal” and “distal” refer to a position of portions of the syringe with reference to an operator (e.g. a dentist or any practitioner), i.e. the term “proximal” refers to a position closer to the operator of the syringe, while the term “distal” refers to a position that is more distant from the operator.
In the lockable syringe of the invention, the dispensing of the drug is achieved by unlocking the locking mechanism of the syringe of the invention. Thanks to the specific arrangement of the locking mechanism, the practitioner is aware of the drug that is about to be dispensed to the patient. In the present invention, the locking system is not suitable to be used when the plunger is pulled backwards (creating negative pressure).
According to one embodiment, the locking mechanism may comprise an adapter configured to be attached to the proximal end of the syringe body and comprising means for receiving the locking ring. Advantageously, the adapter may be a separated molded component or may be molded with the syringe body. In this way, and whatever the molding of the adapter, the locking ring may be easily connected to the proximal end of any kind of syringes. Furthermore, the adapter does not modify the good seal between the syringe body and the plunger.
According to one embodiment, means for receiving the locking ring comprise at least one groove. In this manner, the locking ring is both properly connected to the adapter and is free in its rotation about the longitudinal axis of the syringe body.
According to one embodiment, the adapter is located on the flanges of the syringe body. This specific arrangement allows connecting the locking mechanism on the syringe body while keeping good handling of the device by the practitioner.
According to one embodiment, the locking ring comprises at least two visual indicators, preferably 2, 3, 4, 5, 6, 7 or 8 visual indicators, which may be of the same or different nature. In the lockable syringe of the invention, the presence of at least two visual indicators on the outer surface of the locking ring, forces the practitioner to adjust the position of the locking ring in view of another visual indicator located on the plunger.
The suitable adjustment of at least one of the visual indicators of the locking ring with a visual indicator on the plunger allows unlocking the locking mechanism and finally, the dispensing of the drug pre-filled in the syringe body. Consequently, the risks for dispensing the wrong drug to a subject is strongly reduced because the practitioner needs to align the visual indicator on the rod with the indicator on the locking ring indicating for example the drug present in the syringe. According to one embodiment, the locking ring has a cylindrical shape. According to one embodiment, the shape of the locking ring is not a U-shape nor a C-shape.
According to one embodiment, means for blocking the plunger stroke in a lock position comprise at least one tab. According to one embodiment, when means for blocking the plunger stroke in a lock position comprise at least one tab, the plunger comprises at least one notch on the distal plate configured for receiving said tab and providing an unlock position. In this way, the syringe is initially in a locked configuration in which the plunger cannot be pushed inside the syringe body and consequently, the drug cannot be dispensed. For unlocking the locking mechanism, the operator has to move to a suitable position the tab of the locking ring in front of the notch present on the distal plate of the plunger, said tab and notch being not visible from the operator. In this manner, the operator is made more aware of the action in progress.
According to one embodiment, the notch is marked by a visual indicator on the rod of the plunger. According to one embodiment, the visual indicator of the rod marks only one unlocked position. According to one embodiment, the at least one tab is aligned on one visual indicator present on the outer surface of the locking ring. In this way, the operator has to rotate the locking ring for aligning the visual indicator of the locking ring corresponding to the tab with the visual indicator of the plunger corresponding to the notch, said alignment between these two visual indicators leading to unlock the locking mechanism. According to one embodiment, the visual indicator is not for marking a dosage indication.
According to one embodiment, the plunger and the locking ring are connected together so that means for blocking the plunger stroke in a locked position, are not visible from the operator. According to one embodiment, the plunger and the locking ring are connected together so that means for unlocking the locked position are not visible from the operator. According to one embodiment, the plunger does not rotate with respect to the piston. Advantageously, this specific configuration forces the operator to think more about the action in progress and in particular the consistency between the compound to be delivered to his patient and that which is in the pre-filled syringe.
According to one specific embodiment, in the lockable syringe of the invention:
According to one embodiment, the locking mechanism is made of plastic.
The lockable syringe of the invention is particularly of interest in the medical field. According to one embodiment, the lockable syringe is a pre-filled syringe. Preferably the syringe is pre-filled with a drug, more preferably selected from the following drugs or acceptable salts thereof: midazolam, ropivacaine, lidocaine, mepivacaine, bupivacaine, levobupivacaine, lidocaine epinephrine, naloxone, urapidil, dexamethasone, ondansetron, fentanyl, sufentail, glucose, oxycodone, atracurium, cisatracurium, hydromorphone, alfentanil, prilocaine, chloroprocaine, nicardipine, norepinephrine, propofol, dexmedetomidine, morphine, calcium chloride, calcium gluconate, sodium bicarbonate, furosemide, magnesium sulfate, glycopyrronium, neostigmine, neostigmine/glycopyrronium, rocuronium, sugammadex, ketamine, adenosine, vecuronium, tranexamic acid, amiodarone, diazepam, droperidol, atropine, phenylephrine, ephedrine, suxamethonium, atosiban, baclofen, dobutamine and dopamine.
Another subject of the invention is a method for dispensing a drug to a subject by means of a lockable syringe having a locking mechanism as described above, comprising steps in which:
(a) determining the drug that has to be dispensed to the subject;
(b) identifying the visual indicator corresponding to the drug determined at step (a), among the at least two visual indicators present on the outer surface of the locking ring;
(c) rotating the locking ring so that the visual indicator of the drug identified at step (b) is aligned with a visual indicator on the plunger marking the unlock position of the locking mechanism; and
(d) pushing the plunger so that dispensing the drug pre-filled in the lockable syringe.
According to one embodiment, the method of the invention is not for adjusting a dosage of a drug prefilled in the syringe. Advantageously, the lockable syringe and/or the locking mechanism of the invention may be easily industrialized. Advantageously, the pre-filled syringe of the invention is ergonomic and simple to be used by the operator so that checking step of the drug inside the pre-filled syringe, is fast and easy to implement.
In the present invention, the following terms have the following meanings:
Features and advantages of the invention will become apparent from the following description of several embodiments of a lockable syringe according to the invention, this description being given merely by way of example and with reference to the appended drawings in which:
The locking ring 31, presented in
According to one embodiment, the literal indicators 311 may include the name of the drug or the pharmaceutical formulation such as for example, the trademarks or any commercial designation of the medicament, or the abbreviation of the drug or the pharmaceutical formulation such as for example, the trigram of the name of the drug, or the drug concentration.
In the lockable syringe of the invention 1, the locking ring 31 is connected to the syringe body 2 thanks to the adapter 33. According to one embodiment, when connected to the syringe body 2 and/or the adapter 33, the locking ring 31 is able to freely rotate on itself, around the longitudinal axis of the syringe body 2. According to one embodiment, the locking ring 31 is able to freely rotate on itself, around the longitudinal axis of the syringe body 2 without slidably moving along the longitudinal axis of the syringe body 2. According to one embodiment, the locking ring 31 does not slidably move along the longitudinal axis of the syringe body 2. According to one embodiment, when connected to the syringe body 2 and/or the adapter 33, the locking ring 31 does not enclose any part of the syringe body 2. According to one embodiment, the locking ring 31 does not comprise any hinge.
As presented in
As presented in
The locking ring 31 further comprises means 312 for blocking the plunger stroke in a locked position. According to one embodiment, means 312 for blocking the plunger stroke include at least one tab in the inner volume of the locking ring 31, as presented in
The plunger 32, presented in
According to one embodiment, the plunger 32 and/or the rod 322 does not comprise any grooves. According to one embodiment, the plunger 32 and/or the rod 322 does not comprise any grooves of variable length. According to one embodiment, the plunger 32 and/or the rod 322 does not comprise any grooves of variable length wherein the length of the grooves corresponds to a dosage indicator. According to one embodiment, the plunger 32 and/or the rod 322 does not comprise means for partially advancing inside the syringe body 2. According to one embodiment, the plunger 32 does not rotate on itself or around the longitudinal axis of the syringe body 2. According to one embodiment, the plunger 32 does not rotate with respect to the piston 5. Especially, as presented in
According to one embodiment, visual means 3221 may be colored indicators, literal indicators and/or any pictograms. According to one embodiment, said visual means 3221 for marking an unlock position do not include means for unlocking the locking system. According to one embodiment, said visual means 3221 are not dosage indicators. According to one embodiment, said visual means 3221 are not for adjusting the dose of a drug. In an alternative embodiment, the rod 322 includes tangible means for marking an unlock position such as for example a serigraphy, a projection, a groove, or any other suitable means.
As clearly visible in
According to one embodiment, the syringe body 2, the piston 5, the adapter 33, the locking ring 31 and/or the plunger 32 is (are) made of plastic. According to one embodiment, the piston 5 may be made of an elastomer or a silicone.
A method of dispensing a material (preferably a drug or a pharmaceutical composition) by means of the lockable syringe 1 according to the invention, comprises steps as described below.
Initially, the lockable pre-filled syringe 1 is in the storage configuration shown in
The lockable syringe has been previously filled with a component selected from any drugs or pharmaceutical compositions in a form suitable for parenteral administration (such as by intravenous, intramuscular or subcutaneous injection or intravenous infusion).
In this configuration, the locking mechanism 3 is in a locked position: the notch 3211 present on the distal plate 321, is not aligned with the tab 312 of the locking ring 31 so that the plunger stroke inside the syringe body 2 is blocked. As seen in
For unlocking the locking mechanism 3, the operator has to first identify the component pre-filled inside the syringe 1 and then, to locate the visual indicator 311 corresponding to this pre-filled component, on the locking ring 31. According to one embodiment, the visual indicator 311 is on the outer surface of the locking ring 31.
Secondly, the operator has to rotate the locking ring 31 on itself about the longitudinal axis of the syringe body 2 in order to fit the visual indicator 311 corresponding to this pre-filled component on the locking ring 31, with the visual indicator 3221 of the rod 322 of the plunger 32. In this way, the tab 312 of the locking ring 31 is aligned with the notch 3211 of the plunger 32 (as seen
Finally, the operator has to push the plunger inside the syringe body for dispensing the component pre-filled inside said syringe.
Advantageously, the locking mechanism 3 of the invention makes the operator more aware of the use of the pre-filled syringe, and in particular of the content of the syringe that the operator is preparing to deliver. Indeed, for using the lockable syringe of the invention, the operator has to be sure of its content, and the lockable mechanism will be unlocked only if the content has been properly identified by the operator. Consequently, the lockable syringe of the invention is safer than conventional pre-filled syringes.
The invention is not limited to the examples described and shown. In particular, other materials and shapes than those described above can be considered for the constitutive members of a lockable syringe according to the invention.
Number | Date | Country | Kind |
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20306058.7 | Sep 2020 | EP | regional |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2021/075707 | 9/17/2021 | WO |