SYRINGE FOR RECONSTITUTING AND INJECTING A PHARMACEUTICAL SOLUTION

Abstract

A prefilled syringe includes a tubular containment body extending along an axis between a front end element and a rear end element, a fixed plug and two sliding plugs. A bypass channel in the initial position of the syringe is between the first two plugs which form, together with a third plug at the end of the syringe plunger, a first containment chamber containing a first liquid substance and a second containment chamber containing a second solid or liquid substance. The fixed plug is in contact with the front end element and is provided with a non-through cavity offset with respect to the axis and facing towards the front end element.

Claims

1.-14. (canceled)

15. A prefilled injection device, comprising: a tubular containment body, which extends along an axis between a front end element and a rear end element, the front end element comprising a spout, a needle being connectable to said spout; a first plug and a second plug arranged inside the tubular containment body, so as to delimit therebetween a second containment chamber in the tubular containment body, the second containment chamber containing a second solid or liquid substance; a third plug connected to a syringe piston and forming a first containment chamber with said second plug in the tubular containment body, the first containment chamber containing a first liquid substance; and at least one bypass channel, configured to assume alternatively a closed state or an opened state; wherein: the first plug is arranged in a fixed position either near or in contact with said front end element along said axis; the second plug hermetically separates the first containment chamber from the second containment chamber; the second and third plugs are configured to slide inside the tubular body; the tubular containment body comprises an inner wall provided with a recess defining said at least one bypass channel, wherein the at least one bypass channel is positioned between the first plug and the second plug in an initial configuration of the first and second plugs; and said first plug comprises liquid communication means for passing, upon a movement of the syringe piston towards the front end element, from a first closed state to a second opened state.

16. The prefilled injection device of claim 15, wherein a length of the at least one bypass channel is larger than a total length of the second plug but smaller than the sum of the lengths of the third and second plugs.

17. The prefilled injection device of claim 15, wherein said liquid communication means are provided in the structure of said first plug, wherein the liquid communication means in the first plug comprise a watertight closure with respect to said front end element in said first closed state and said first plug is shrunk perpendicularly to said axis in said second opened state, thereby forming a liquid communication channel between said second containment chamber and said front end element.

18. The prefilled injection device of claim 17, wherein said liquid communication means in the first plug comprise a non-through cavity which is offset with respect to said axis and facing towards said front end element.

19. The prefilled injection device of claim 15, wherein the front end element is made of plastic material.

20. The prefilled injection device of claim 15, wherein the front end element is made in one piece with the tubular body.

21. The prefilled injection device of claim 15, wherein the rear end element is made of plastic material.

22. The prefilled injection device of claim 15, wherein the rear end element is made in one piece with the tubular body.

23. The prefilled injection device of claim 15, wherein the tubular body is made of plastic or glass material.

24. The prefilled injection device of claim 15, wherein the first liquid substance is a solvent for injectable use and the second substance is an active substance or one of an antibiotic, a beta-lactam antibiotic, Cephalosporin, Penicillin antibiotic, a cytotoxic anticancer substance, a hormone, a biological preparation, a biotechnological product, a monoclonal antibody, a protein, a vaccine, and an anesthetic.

25. A prefilled injection device, comprising: a tubular containment body, which extends along an axis between a front end element and a rear end element, the front end element comprising a spout, a needle being connectable to said spout; a first plug and a second plug arranged inside the tubular containment body, so as to delimit therebetween a second containment chamber in the tubular containment body, the second containment chamber containing a second solid or liquid substance; a third plug connected to a syringe piston and forming a first containment chamber with said second plug in the tubular containment body, the first containment chamber containing a first liquid substance; and at least one bypass channel, configured to assume alternatively a closed state or an opened state; wherein: the first plug is arranged in a fixed position either near or in contact with said front end element along said axis; the second plug hermetically separates the first containment chamber from the second containment chamber; the second and third plugs are configured to slide inside the tubular containment body; the at least one bypass channel is provided in the second plug; and said first plug comprises liquid communication means for passing, upon a movement of the syringe piston towards the front end element, from a first closed state to a second opened state.

26. The prefilled injection device of claim 25, wherein the at least one bypass channel consists of a one-way valve integrated in said second plug.

27. The prefilled injection device of claim 26, wherein the at least one bypass channel consists of inner elements of the second plug which are collapsible or breakable under liquid pressure.

28. The prefilled injection device of claim 25, wherein said liquid communication means are provided in the structure of said first plug, wherein the liquid communication means in the first plug comprise a watertight closure with respect to said front end element in said first closed state and said first plug is shrunk perpendicularly to said axis in said second opened state, thereby forming a liquid communication channel between said second containment chamber and said front end element.

29. The prefilled injection device of claim 28, wherein said liquid communication means in the first plug comprise a non-through cavity which is offset with respect to said axis and facing towards said front end element.

30. The prefilled injection device of claim 25, wherein the front end element is made of plastic material.

31. The prefilled injection device of claim 25, wherein the front end element is made in one piece with the tubular body.

32. The prefilled injection device of claim 25, wherein the rear end element is made of plastic material.

33. The prefilled injection device of claim 25, wherein the rear end element is made in one piece with the tubular body.

34. The prefilled injection device of claim 25, wherein the tubular body is made of plastic or glass material.

35. The prefilled injection device of claim 25, wherein the first liquid substance is a solvent for injectable use and the second substance is an active substance or one of an antibiotic, a beta-lactam antibiotic, Cephalosporin, Penicillin antibiotic, a cytotoxic anticancer substance, a hormone, a biological preparation, a biotechnological product, a monoclonal antibody, a protein, a vaccine, and an anesthetic.

Description

DETAILED DESCRIPTION OF EXAMPLES OF PREFERRED EMBODIMENTS OF THE INVENTION

List of Drawings

[0014] The invention will now be described by way of example, with particular reference to the drawings of the accompanying figures, in which:

[0015] FIG. 1 shows the different and progressive states of use of a double chamber syringe for the subsequent administration of two liquids, according to the prior art;

[0016] FIG. 2 shows a sliding plug used in the syringe of FIG. 1, according to the prior art;

[0017] FIG. 3 shows a double chamber syringe for the pre-reconstruction of a solution and subsequent administration of the solution, according to the known art;

[0018] FIG. 4 shows the different and progressive states of use of a double chamber syringe for the pre-reconstruction of a solution and subsequent administration of the solution, according to the present invention;

[0019] FIG. 5 shows the same plug as FIG. 2, this time used in the device of FIG. 4; and

[0020] FIG. 6 shows the same embodiment as FIG. 4, but with the liquids/powder in motion.

[0021] It is worth noting that hereinafter elements of different embodiments may be combined together to provide further embodiments without limitations respecting the technical concept of the invention, as a person skilled in the art will effortlessly understand from the description.

[0022] The present description also makes reference to the prior art for its implementation, with regard to the detail features which are not described, such as, for example, elements of minor importance usually used in the prior art in solutions of the same type.

[0023] When an element is introduced, it is always understood that there may be “at least one” or “one or more”.

[0024] When a list of elements or features are listed in this description, it is understood that the finding according to the invention “comprises” or alternatively “consists of” such elements.

Embodiments

[0025] With reference to FIGS. 4 and 5, the prefilled injection device 400 comprises, according to an embodiment of the present description, a typical tubular containment body 430, which extends along an axis (not shown) between a front end element 420 and a rear end element 410. It is apparent that, as in all syringes, the front end element 420 is a partial closure element, with a spout 421 to which a needle or a small tube (not shown) is connected for administering or transferring the liquid or solution into the syringe.

[0026] Since this is a device in which the substances are already in the syringe and must be mixed, there are a first plug 470 and a second plug 460 arranged inside the tubular body 430 of the syringe, so as to delimit therebetween a second containment chamber 400L2 in the tubular body 430 itself containing a second liquid substance. At the same time, there is a third plug 450 connected to a syringe piston (not shown) and forming a first containment chamber 400L1 with said second plug 460 in the tubular body 430. The second containment chamber 400L2 contains a second substance, either solid or liquid, e.g. in powder form.

[0027] The second plug 460 hermetically separates the first containment chamber 400L1 from the second containment chamber 400L2. The second plug 460 and the third plug 450 are configured and adapted to slide inside the tubular body 430.

[0028] It is further apparent that, as in the traditional syringes of this type, there is at least one bypass channel 440, initially in a closed state and adapted to be taken into an opened state for mixing said first and said second substance. The bypass channel may be formed in various manners in the syringe.

[0029] According to an embodiment of the present description, and contrarily to the mentioned known art, in the prefilled injection device or syringe 400 the first plug 470 is arranged in a fixed position in contact with or near said front end element 420 along the axial direction. “Proximity” means a distance (either minimum or not) of construction convenience which can be easily determined according to the case.

[0030] It is worth noting here that the solution of application WO2017216651 A1 cannot use such a plug in fixed position, because such a device must store a predetermined amount of reconstituted liquid and must be able to move the plugs to allow the administration thereof. Furthermore, the bypass cannot be placed, in the initial state, between the two plugs, but both plugs must stay above the bypass, thereby limiting the amount of substances in the syringe.

[0031] By putting a fixed plug into abutment at the front end of the syringe as shown, a passage for the liquid is needed, and it is desirable that this does not complicate the constitution of the syringe itself.

[0032] This is achieved, according to an aspect of the present description, with a plug deformable under the pressure of the liquid which is pushed by the action of the plunger or piston of the syringe 400. In general, one-way passage means may be used, e.g. such as one-way valves. More in general, liquid communication means with said front end element 420 will be provided with/in said first plug.

[0033] According to a preferred embodiment, the first plug 470 is provided with a non-through cavity 445 which is offset with respect to said axis and facing towards said front end element 420 (the cavity 445 of 470 is facing towards 420, because if it were facing 410 it would be filled with solution, thereby making the plug stick on the walls of 430, because it is filled with liquid). This allows the plug to contract at least partially perpendicularly to said axis, and thus to create a channel 471 with the body 430 up to the spout 421 of the end element 420.

[0034] FIG. 5 shows an embodiment of the plug 470 with cavity 445, according to the invention.

[0035] The deformability, that is the narrowing of the plug 470 can be achieved by means of various inner configurations of the plug itself, e.g. by providing inner elements which can collapse or break (and in this case the parts which will break will remain advantageously coupled to the rest of the structure of the plug) under liquid pressure.

[0036] According to an embodiment of the present invention, the tubular body 430 comprises an inner wall provided with a recess adapted to define the bypass channel 440. In the initial configuration of the plugs, the bypass channel is positioned between the first plug 470 and the second plug 460.

[0037] According to a preferred aspect of the present description, the length of the bypass channel 440 is larger than the total length of the second plug 460, but smaller than the sum of the lengths of the plugs 450 and 460 (to prevent the liquid from flowing back once the third one 450 reaches the second one 460).

[0038] Alternatively, the bypass channel may be provided in the second plug 460, e.g. with a shrinkage following a collapse of the inner structure, or with an appropriate one-way valve (e.g. breakable membrane).

[0039] From the point of view of the materials of the syringe 400, according to the present description, the front end element 420 can be made of plastic material and/or made in one piece with the tubular body 430. Similarly, the rear end element 410 may be made of plastic material and/or made in one piece with the tubular body. The tubular body may be made of plastic or glass, for example.

[0040] From the point of view of the substances present from the beginning in the syringe, the first liquid substance is a solvent for injectable use and the second substance may be an active substance or a highly active substance, e.g. an antibiotic, or a beta-lactam antibiotic (Cephalosporin and/or Penicillin antibiotic), or a cytotoxic anticancer substance, or a hormone, or a biological preparation, or a biotechnological product, or a monoclonal antibody, or a protein, or a vaccine, or an anesthetic.

[0041] Turning to the steps of operation of the device according to the present description, FIG. 4(a) shows the starting state of the device as described above, in which the plunger is not shown for ease of representation. The plunger can be connected to the third plug 450.

[0042] In FIG. 4(b), the plunger starts moving the plug 450 and, by means of the liquid of the chamber 400L1, also the plug 460 towards the zone of the bypass 440. Again in FIG. 4(b), the bypass is activated because of the position of the plug 460 inside the bypass itself, thereby allowing the liquid to pass from 400L1 to 400L2.

[0043] In FIG. 4(c), once the bypass is activated because of the position of 460 inside the bypass itself, 450 and 460 end up touching each other, the liquid being passed either entirely or almost totally from chamber 400L1 to chamber 400L2, thereby reconstituting itself with the second substance.

[0044] At this point, again with further push of the piston and thus of the plug 450, the second chamber 400L2 is reduced to FIG. 4(d) and substantially or totally canceled in the final state of FIG. 4(e). This is possible by virtue of the fluid communication means comprised in or constituting the front plug 470, which allow the reconstituted substance to reach the spout 421 and from there a needle or a tube or other fluid connection to a third body (e.g. the body of a patient who is injected with the syringe of the present description).

[0045] FIG. 6 shows the injection sequence as in FIG. 4 but with the various materials indicated in the syringe 400 with different patterns.

Advantages of the Invention

[0046] As explained above, among the advantages obtained with the device of the present description, there is the simple structure of the syringe with maximization of the substances to be injected at the same time. The substances to be (reconstituted and) injected being equal, smaller syringes than those of the prior art can therefore be made.

[0047] For this reason, but also because of the general shape similar to that of the prior art, and for the simplicity of the characterizing elements, production costs are minimized and operation is optimal.

[0048] Hereto, we have described the preferred embodiments and suggested some variants of the present invention, but it is understood that a person skilled in the art can make modifications and changes without departing from the respective scope of protection, as defined by the appended claims.