The present invention relates to the technical field of syringes for injecting pharmaceutical products, in particular to prefilled multiple chamber syringes.
Currently, sterile raw materials in powder form are mainly packed by active ingredient manufacturers either in aluminum containers or in plastic bags, generally made of polyethylene.
In order to be able to market them, manufacturers have demonstrated that each raw material, in addition to maintaining sterility, remains stable in the containers or bags used for a given period of time; in other words, such powders do not degrade for a predefined number of years when stored in such containers or bags.
The sterile raw materials are sold to the manufacturers of the finished pharmaceutical product, who fractionate them using known technologies, marketing the finished product in sterile powder form contained in a bottle. The bottle is accompanied by a glass vial containing the solvent.
The use of high-quality materials for the vial (glass) and of compatible materials for the sterile powder and the use of disposable syringes make this system very costly as a whole.
The use of syringes provided with a compartment for holding a cartridge, made of flexible material, containing pharmaceutical substances kept separate until the moment of use by a special soft septum, is known in the sector. An example of such devices is described in patent US2001/0047162. However, such known devices have some drawbacks. Indeed, due to accumulations and stagnations of the mixture or of the pharmaceutical substance in the corners of the cartridge, not the whole dose is delivered. This makes the dosage of the substance actually injected inaccurate and unreliable.
Other solutions, such as the Debiopass™ by Debiotech S.A. shown in
A further solution is shown in
One of the prior arts which emerged in application WO2017216651 A1, i.e. European patent application EP0568321 A2, shows solutions similar to the above, in which the front plug must be pierced by a double tip syringe needle or a second bypass, which bypasses the front plug itself, is used. In the first case, the piercing operation is not sufficiently safe; in the second case, the construction of a second bypass is complicated. In both cases, structures and elements must be introduced which require a more articulated production line and therefore the product will be more expensive as a whole, while its operation will be far from optimal.
It is the object of the present invention to solve the problems of the prior art by taking the needs of the sector into account.
In particular, it is the object of the present invention to provide a device for delivering pharmaceutical substances which allows an optimal operation by means of a simple and inexpensive system.
The present invention relates to a prefilled injection device according to one or more of the appended claims.
The invention will now be described by way of example, with particular reference to the drawings of the accompanying figures, in which:
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.
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.
When an element is introduced, it is always understood that there may be “at least one” or “one or more”.
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.
With reference to
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
Turning to the steps of operation of the device according to the present description,
In
In
At this point, again with further push of the piston and thus of the plug 450, the second chamber 400L2 is reduced to
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.
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.
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.
Number | Date | Country | Kind |
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102018000009185 | Oct 2018 | IT | national |
Filing Document | Filing Date | Country | Kind |
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PCT/IB2019/056316 | 7/24/2019 | WO | 00 |