LOCKABLE SYRINGE FOR SAFELY DISPENSING A DRUG

Abstract

A lockable syringe, which includes a syringe body having a longitudinal axis and including a distal end and a proximal end, and a locking mechanism, wherein the locking mechanism is configured to be attached to the proximal end of the syringe body. The locking mechanism includes: a plunger having at least one distal plate, and a rod with visual elements for marking an unlock position; and a locking ring which is free in its rotation about the longitudinal axis of the syringe body, the locking ring has at least two visual indicators on its outer surface, and the locking ring has elements for blocking the plunger stroke in a locked position.

Claims

1-15. (canceled)

16. A lockable syringe for dispensing a drug, comprising: a syringe body having a longitudinal axis and comprising a distal end and a proximal end; and a locking mechanism; wherein: said locking mechanism is configured to be attached to the proximal end of the syringe body, and said locking mechanism comprises: a plunger having at least one distal plate, and a rod with visual means for marking an unlock position; and a locking ring which is free in its rotation about the longitudinal axis of the syringe body said locking ring has at least one visual indicator on its outer surface, and said locking ring has means for blocking the plunger stroke in a locked position.

17. The lockable syringe according to claim 16, wherein the locking mechanism further comprises an adapter configured to be attached to the proximal end of the syringe body and comprising means for receiving the locking ring.

18. The lockable syringe according to claim 17, wherein the adapter is molded with the syringe body.

19. The lockable syringe according to claim 16, wherein means for receiving the locking ring comprise at least one groove.

20. The lockable syringe according to claim 17, wherein the adapter is located on the flanges of the syringe body.

21. The lockable syringe according to claim 16, wherein the locking ring comprises at least two visual indicators which may be of the same or different nature.

22. The lockable syringe according to claim 16, wherein means for blocking the plunger stroke in a lock position comprise at least one tab.

23. The lockable syringe according to claim 16, wherein 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.

24. The lockable syringe according to claim 23, wherein the notch is marked by a visual indicator on the rod of the plunger.

25. The lockable syringe according to claim 16, wherein 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.

26. The lockable syringe according to claim 22, wherein the at least one tab is aligned on one visual indicator present on the outer surface of the locking ring.

27. The lockable syringe according to claim 16, wherein the locking mechanism is made of plastic.

28. The lockable syringe according to claim 16, wherein the lockable syringe is a pre-filled syringe.

29. The lockable syringe according to claim 28, wherein the syringe is pre-filled with a drug.

30. The lockable syringe according to claim 29, wherein the drug is 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.

31. The lockable syringe according to claim 16, wherein: the plunger comprises a colored indicator on its rod, for marking the unlock position of the locking mechanism; and the locking ring comprises on its outer surface, from 4 to 8 different visual indicators, and has one tag in its inner surface, for blocking the plunger stroke in a locked position.

Description

DESCRIPTION OF THE DRAWINGS

[0039] 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:

[0040] FIG. 1 is an exploded perspective view of a lockable syringe of the invention;

[0041] FIG. 2 is a longitudinal section of the lockable syringe in a first embodiment of the invention in which the locking mechanism is in a locked position (FIG. 2A) and in a second embodiment in which the locking mechanism is in an unlocked position (FIG. 2B).

[0042] FIG. 3 is a perspective view of the adapter comprising a flat surface and a ring;

[0043] FIG. 4 is a perspective view of the locking ring comprising a tab and visual indicators;

[0044] FIG. 5 is a perspective view of the plunger comprising a rod, a distal plate and a connective rod;

[0045] FIGS. 6A and 6B illustrate an enlarged view of the connection between the syringe body and the locking mechanism of FIGS. 2A and 2B, respectively.

ILLUSTRATIVE EMBODIMENTS OF THE INVENTION

[0046] FIG. 1 shows an exploded view of a lockable syringe 1 suitable for safely dispensing of a drug. As visible in FIG. 1, the lockable syringe 1 comprises a syringe body 2 with a tip 4 at its distal end, and a locking mechanism 3 at its proximal end, said locking mechanism 3 being aligned along the longitudinal axis of the syringe body 2 as presented in FIG. 2. Said locking mechanism comprises a locking ring 31, a plunger 32 and an adapter 33.

[0047] The locking ring 31, presented in FIG. 4, comprises at least two visual indicators 311 on its outer surface. Especially, the visual indicators 311 are on the proximal outer surface of the locking ring 31. Alternatively, the visual indicators 311 may also be located on the distal outer surface or any other arrangements on the outer surface of the locking ring 31. In FIG. 1 or in FIG. 4, the visual indicators 311 are colored indicators and/or literal indicators and/or numeral indications (such as figures or codes); each of the visual indicators 311 corresponding to one drug or one pharmaceutical composition. According to one embodiment, the visual indicators 311 are each independently selected from colored indicators and literal indicators. According to one embodiment, the drug prefilled in the syringe body 2 is represented on the locking ring 31 by one color and/or literal indicators, preferably the color and the literal indicators representative of the prefilled drug are different from the other visual indicators 311 of the locking ring 31. According to one embodiment, the visual indicators 311 are both colored indicators and literal indicators; and all the visual indicators represent the same color but are different literal indicators. According to one embodiment, the visual indicators 311 are both colored indicators and numeral indicators; and all the visual indicators represent the same color but are different numeral indicators. According to one embodiment, the numeral indicator represents a drug concentration. In the present invention, at least one visual indicator 311 corresponds to the drug or the pharmaceutical composition pre-filled in the syringe body 2. According to one embodiment, only one visual indicator 311 corresponds to the drug or the pharmaceutical composition pre-filled in the syringe body 2. In the present invention, the other visual indicators 311 correspond to other drugs or pharmaceutical compositions than those pre-filled in the syringe body 2, said others drugs or pharmaceutical compositions having the same pharmaceutical function or not, as the pre-filled drug or pharmaceutical composition. According to one embodiment, when the visual indicators 311 are colored indicators, the color is chosen according to the medical classification of drugs according to the norm ISO 26825 2008. Examples of colors used in the medical classification of drugs are presented in the table hereinabove.

TABLE-US-00001 Class of drugs PMS* color Examples Hypnotics Primary Yellow C Thiopental, methohexital, propofol, ketamine Benzodiazepine Orange 151 Diazepam, midazolam Antagonists of Orange 151 with white Flumazenil benzodiazepines diagonal stripes Curariants Fluorescent red 811 or Suxamethonium, d-tubocurarine, hot red pancuronium, atracurium, vecuronium Antagonists of Fluorescent red 811 or Neostigmine, edrophonium, curariants hot red, with white pyridostigmine diagonal stripes Opioids Blue 297 Morphine, fentanyl, pethidine Antagonists of opioids Blue 297 with white Naloxone diagonal stripes Sympathicomimetics Purple 256 Adrenalin, ephedrine, phenylephrine, metaraminol antihypertensives Purple 256 with white Nitroprussiate, nitroglycerin, diagonal stripes phentolamine, hydralazine local anesthetics Grey 401 Procaine, lidocaine, bupivacaine, ropivacaine anticholinergics Green 367 Atropine, glycopyrronium antiemetics Salmon 156 Droperidol, metoclopramide, ondansetron Others drugs white Ocytocine, heparin, protamine, potassium chloride, tacrine, antibiotics, non-steroidal anti-inflammatory drugs *PMS means Pantone Matching System ® which is the Pantone ® system for comparing colors.

[0048] 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.

[0049] 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.

[0050] As presented in FIG. 3, the adapter 33 comprises a flat surface 331 surmounted by a ring 332. As presented in FIG. 2, the locking ring 31 is not engaged in the syringe body 2. Thus, the outer surface of the locking ring 31 remains visible from the operator whatever the locked or unlocked configuration of the locking mechanism.

[0051] As presented in FIGS. 2 and 6, the flat surface 331 of the adapter 33 is clipped on the flanges 21 of the syringe body 2 at its proximal end so that the adapter 33 is securely attached without impeding the grip of the syringe by the operator at the level of the flanges. The ring 332 of the adapter 33 has means for connecting the locking ring 31. In particular, when the adapter 33 and the locking ring 31 are attached to each other, the ring 332 of the adapter 33 disappears in the partially or totally inner volume of the locking ring 31. According to one embodiment, the locking ring 31 connects to the ring 332 of the adapter 33 thanks to a projection in its inner surface, said projection being configured for fitting with the at least one groove (preferably, an outer peripherical groove) present inside the outer surface of the ring 332 of the adapter 33.

[0052] 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 FIGS. 2 and 4. Especially, the longitudinal axis of the tab as presented in FIG. 4, is transvers to the longitudinal axis of the locking ring 31 and/or of the longitudinal axis of the syringe body 2. According to one embodiment, the tab is located on an inner diameter of the locking ring 31 and at the proximal end of said locking ring 31.

[0053] The plunger 32, presented in FIG. 5, comprises at least one distal plate 321, a rod 322 and a connective rod 323. As seen in FIG. 5, the distal plate 321 is located between the rod 322 and the connective rod 323. According to one embodiment, the connective rod 323 has a length higher than the length of the locking ring and lower than the length of the rod 322. According to one embodiment, the connective rod 323 has a diameter lower than the diameter of the rod 322. The distal plate 321 includes means 3211 for cooperating with means 312 of the locking ring 31 so that it is possible to either prevent (locking position) or enable (unlocking position) the advancement of the plunger, preferably of the rod 322, inside the syringe body 2. The rod 322 comprises a finger grip. According to one embodiment, the rod 322 comprises at least 2 wings, preferably 3, 4 or 5 wings. According to one embodiment, the rod 322 does not comprise any wing. According to one embodiment, the rod 322 is cylindrical. According to one embodiment, the cross section of the rod 322 is a cross. According to one embodiment, the rod 322, preferably the wings of the rod 322, does not comprise any rib portions.

[0054] 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 FIGS. 1 and 2, the rod 322 includes visual means 3221 for marking an unlock position; said visual means 3221 being visible by the operator when the syringe mechanism is locked.

[0055] 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.

[0056] As clearly visible in FIG. 5, visual means 3221 on the rod 322 points out a position on the distal plate 321 of a specific arrangement able to cooperate with means 312 for unlocking the locking mechanism 3 and allowing freely moving the plunger 32 inside the syringe body 2. The plunger 32 also comprises a connective rod 323 for solidly fixing the plunger 32 to the piston 5 inside the syringe body 2. The connective rod 323 comprises at its distal end, a plate 3231, preferably having the same diameter as that of the distal plate 321.

[0057] 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.

[0058] 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.

[0059] Initially, the lockable pre-filled syringe 1 is in the storage configuration shown in FIGS. 2A and 6A, in which the rod 322 of the plunger 32 is out of the syringe body 2 and of the locking ring 31.

[0060] 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).

[0061] 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 FIGS. 2A and 6A, the tab 312 is a stopper for the distal plate 321. The tab 312 is preferably located in the inner volume of the locking ring 31. Consequently, the drug pre-filled in the syringe cannot be dispensed.

[0062] 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.

[0063] 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 FIGS. 2B and 6B), leading to free the stroke of the plunger inside the locking ring 31 and of the syringe body 2.

[0064] Finally, the operator has to push the plunger inside the syringe body for dispensing the component pre-filled inside said syringe.

[0065] 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.

[0066] 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.