Deformable pre-packaging device for injecting liquids

Abstract

The present invention relates to a device (100) for injecting a reconstitutable mixture, comprising first and second storage chambers (40, 30) for the first and second components of the mixture, respectively, first mechanical and fluid connection means (43, 33) between the first and second storage chambers (40, 30), and second mechanical and fluid connection means (20) between the second storage chamber (30) and an injection needle (10). The first chamber (40) comprises first upper and lower surfaces (41, 42) formed in a frustoconical shape with a common axis of symmetry (S) and a common base periphery (44). The first upper and lower surfaces (41, 42) have the common base (44) and extend in opposite directions, forming a non-zero angle β. The second storage chamber (30) has first upper and lower surfaces (31, 32) formed in a frustoconical shape with the same axis of symmetry (S) and a common base periphery (34). The first upper and lower surfaces (31, 32) have the common base (34) and extend in opposite directions to form a non-zero angle α. The first and second lower surfaces (42, 32) are compressively deformable.

Description

[Technical Field]

[0001] The present invention relates to a deformable pre-packaged device for injecting liquids. [Background technology]

[0002] Nowadays, sterile powdered raw materials are primarily packaged in aluminum containers or plastic bags (usually polyethylene-based plastics) by the active ingredient manufacturers.

[0003] To sell them, manufacturers have demonstrated that each ingredient, in addition to remaining sterile, will remain stable within the container or pouch used for a specified period of time, i.e., that such powder will not degrade when stored in the container or pouch for a specified number of years.

[0004] The sterile raw material is sold to manufacturers of finished pharmaceutical products, who, using known techniques, separate and market the finished sterile powder product in bottles that are accompanied by a solvent.

[0005] The use of precious materials for the (glass) vials, the use of compatible materials for sterile powders, and the use of disposable syringes makes this system very expensive worldwide.

[0006] It is known in the art to use syringes with compartments for receiving deformable cartridges made of flexible material, which contain multiple medicinal substances in separate storage chambers by means of temporary yielding partitions until the moment of use. An example of such a known device is disclosed in patent document US 2001 / 0047162. Another example of such a known device is disclosed in patent document WO 2017 / 137854.

[0007] However, maintaining a high degree of isolation between the storage chambers in prior art deformable cartridges has proven difficult, particularly when the storage chambers of the deformable cartridge are filled with different substances, such as a solid and a liquid substance, or two substances that could destabilize the active ingredient if accidentally mixed together prematurely.

[0008] Patent document WO 2020 / 070576 by the present applicant provides isolation by a deformable cartridge P1 having cartridge bodies P10 and P20, as shown in FIG. 1, wherein the deformable cartridge P1: at least one first storage chamber P11 for a first component of the pourable solution, the first storage chamber P11 having at least one first wall deformable by compression; - at least one second storage chamber P21 for a second component of the pourable solvent, the second storage chamber P21 having at least one second wall deformable by compression to allow the transfer of the second component from the second storage chamber P21 to the first storage chamber P11, thereby achieving mixing of the first and second components; a needle P5 connected to the first storage chamber P11; (Figure 1(a)).

[0009] As shown in Figure 1(b), such an apparatus P1 would be used with a dedicated tool P200 to deform the chamber in order to mix the components simultaneously with the injection, which would require the manufacture of dedicated elements, thus resulting in a large investment in molds and materials, and making them difficult to use by the operators performing the injection.

[0010] In particular, the difficulty of use is not only due to the use of a special tool to collapse the chamber, but also to the reduced sensitivity of the operator or nurse when piercing and inserting the needle compared to that obtained with a conventional syringe, where the mixture to be injected is drawn up and held in only one hand.

[0011] WO 2019 / 246435 relates to a bellows device for dispensing a liquid substance, which comprises two chambers that are not separately collapsible and therefore not adapted for separate storage and reconstitution of the substance from the two components. Summary of the Invention

[0012] SUMMARY OF THE INVENTION The present invention aims to provide a deformable pre-packaging device for injecting liquids that at least partially solves the problems of the prior art and at least partially overcomes the drawbacks of the prior art.

[0013] The present invention relates to a device and a corresponding kit as claimed in the accompanying claims. The invention will now be described, by way of example and not by way of limitation, with reference to the accompanying drawings in which: [Brief explanation of the drawings]

[0014] [Figure 1] 1 illustrates a prior art reconstitution and injection device. [Figure 2] FIG. 1 is a longitudinal cross-sectional view of an embodiment of the present invention. [Figure 3] 3A to 3D are diagrams showing the device of FIG. 2 in a series of steps (a) to (d) of use. [Figure 4] 4 is a view showing the same device in a different cross section in the same process as in FIG. 3. DETAILED DESCRIPTION OF THE INVENTION

[0015] It should be noted that, as those skilled in the art will easily understand from the description, the elements of the following different embodiments can be combined together to provide further embodiments without limiting the technical concept of the present invention.

[0016] The present description also refers to the prior art for the implementation of detailed features that are omitted, such as minor elements that are commonly used in the prior art for solutions of the same type.

[0017] Whenever an element appears, it is understood that there can be "at least one" or "one or more."

[0018] Where elements or features are listed in this description, the present invention is understood to "comprise" or, alternatively, "consist of" such elements.

[0019] References to "upper" and "lower" refer to adjacent positions along the axis as may be specified. Specifically, "lower" refers to a position further from the outlet of fluid from the storage element, and "upper" refers to a position closer to the outlet of fluid from the storage element.

[0020] Referring to FIG. 2, in an embodiment, the injection device 100 of the present invention includes: a first storage chamber 40 for the first component of the mixture to be injected; a second storage chamber 30 for the second component of the mixture system to be injected (for example in powder form and shown in dashed lines); These chambers 30, 40 are fluidly connected by (fixed or semi-fixed) mechanical and fluid connection means 33, 43.

[0021] More particularly, such a (first) mechanical and fluid connection means may consist of a fixed or semi-fixed tubular outlet element (or "neck") 43 connected to (or integrally formed with) the first storage chamber 40 and a tubular inlet element 33 connected to (or integrally formed with) the second storage chamber 30.

[0022] A one-way valve may optionally be added to either element 33 or element 43 to allow the passage of liquid from chamber 40 and the retention of liquid in chamber 30 .

[0023] The tubular outlet element 43 and the tubular inlet element 33 are suitably provided with means (not shown) for mechanically coupling them to one another and are preferably watertight (no liquid leakage). The tubular elements 33, 43 may have any cross-section, provided that a watertight fluid connection can be achieved. If the first and second storage chambers are provided separately in an injection kit (optionally including a needle, making it possible to provide other means for administering or expelling the mixture, such as a tube), such tubular elements may be provided with a breakable, openable or removable watertight sealing element, such as a peelable septum.

[0024] The second storage chamber also comprises a tubular outlet element 20 (also referred to as "second mechanical and fluidic connection means") configured so that the infusion needle 10 can be fixed to it (watertight, i.e. without fluid communication with the outside). If the second storage chamber is provided in the kit, the tubular element (or the second mechanical and fluidic connection means) is provided with a removable waterproof sealing element, such as a peelable septum.

[0025] As mentioned above, the first storage chamber 40 and the second storage chamber 30 are stored separately, so that the tubular elements 33, 43 remain detached and are connected when the injection is performed (see Figures 3(a) and 4(a)). The assembly of the elements 33, 43 may be performed in a known manner, for example by threaded and / or rupturable membranes.

[0026] One or both of the tubular elements 33, 43 may be provided with a filter and / or a valve, for example the valve being configured to allow unidirectional flow of the first component of the mixed liquid.

[0027] The first mechanical and fluid connection means 43, 33 comprises an outlet neck of the first storage chamber 40 and an inlet neck of the second storage chamber 30, the outlet neck and the inlet neck being connected to form a single fluidly connecting duct.

[0028] This single fluid connecting duct maintains the first lower surface 42 and the second lower surface 32 apart by a distance greater than the cross section of a finger, which may be standardized to a size that includes all or most human fingers.

[0029] The first storage chamber 40 has a diamond-shaped, conical, or truncated conical cross section in a longitudinal section (the XY plane of the drawing). For example, in the first storage chamber 40, the angle β between the top side 41 and the bottom side 42 (one side of the diamond in the X direction) has a predetermined (non-zero) value before use of the device. The same is true for the angle γ of the bottom end (the apex of the cone 45). The angle γ is between the two sides 42 (one side of the diamond in the X direction) and has a predetermined (non-zero) value before use of the syringe 100. The angle of the top end (in the Y direction) does not exist in this case because the tubular outlet element 43 is fixed at such an apex. In reality, the bottom end 45 may also not exist. A flat portion or other shaped portion may be formed, and such a portion may be pressed with a thumb as described below.

[0030] The second storage chamber 30 also has a diamond shape, and in this case the angle α between the upper side 31 and the lower side 32 (one side of the diamond in the X direction) has a predetermined value before using the device. No lower or upper end angle exists in this case, since the tubular inlet element 33 and the tubular outlet element 20 are fixed in such vertex positions.

[0031] In the above, it is understood that the shape of the storage chamber has a circular extension along the axis of symmetry S of the syringe 100 (in the Y direction) in the volume device, i.e., the cross section is rotated 180 degrees (or each of the corresponding upper and lower sides is rotated 360 degrees) to obtain the volume of the storage chamber, resulting in an overall shape corresponding to the combination of two cones (or something like truncated cones) with apexes on opposite sides along a common base 44 or 34.

[0032] Furthermore, the surface resulting from the above rotation does not necessarily have to have a perfect conical shape, but can be more or less curved, as this does not significantly alter its function.

[0033] In fact, the double cone shape (diamond or similar in cross section) has a very unique function, namely, that the storage chamber can be crushed with the fingers according to the predetermined steps illustrated in Figures 3 and 4, which are not intended to be limiting.

[0034] Specifically, according to an embodiment of the present invention, after mechanically and fluidically coupling the first and second storage chambers 40, 30 (FIGS. 3(b) and 4(b)), a worker (or nurse) who must perform parenteral (or other) administration places the index and middle fingers (or two fingers other than the thumb) of their hand above the diamond 40 (on side 41) while pressing the lower portion of the diamond (side 42; see also the arrow in the figure) with their thumb. This pressing occurs until the latter is crushed against the former, thereby forming an angle γ approximately equal to (180-γ) degrees, allowing the liquid component of the first storage chamber to flow into the second storage chamber. Because the material of the diamond 40 is inelastically deformable (i.e., deformable by compression), this crushed state is maintained even after the pressure between the index and middle fingers on one side and the thumb on the other side is released. This (Fig. 3 / 4(d)) allows the index and middle fingers (or two other fingers other than the thumb) to be repositioned against the upper surface of the storage chamber 30, i.e., side 31 in the cross section, while the thumb continues to press in the same position as before. As in the previous step, the lower surface (wall 32 in the cross section) of the storage container 30 is pressed against the corresponding upper surface (wall 31 in the cross section) (see arrows in the figure). Here, too, the material used may allow for inelastic deformation to ensure safe injection.

[0035] According to one aspect of the present invention, the first lower surface 42 and the second lower surface 32 of the device 100 are made of an inelastically deformable material. Specifically, the inelastically deformable material allows the first lower surface 42 and the second lower surface 32 to be completely collapsed against the first upper surface 41 and the second upper surface 31, respectively, during the various steps of reconstituting and dispensing the mixture. Each chamber 40, 30 is ensured to be independently deformable.

[0036] The needle 10 of the syringe 100 can be conveniently introduced into the body for receiving the dose after step (c) in the figure, or after the two components in the two storage chambers have been reconstituted in the first storage chamber. Obviously, the corresponding initial filling of the two storage chambers (and their sizing) will be such that the entire operation is carried out.

[0037] According to one aspect of the present invention, there is provided a method for reconstituting a reconstitutable mixture and expelling the mixture from an injection needle, the method comprising the following series of steps: - providing a device according to the invention; - placing two fingers on the first upper surface 41 and the thumb against the first lower surface 42; Bringing the thumb close to the two fingers and squeezing the lower surface 42 against the first upper surface 41; - placing two fingers on the second upper surface 31 and a thumb on the first lower surface 42; - bringing the thumb close to the two fingers and squeezing the second upper surface 31 against the second lower surface 32.

[0038] The solution according to the invention allows the two components of the mixture to be injected to be stored in two separate connectable devices, allowing the syringe and the mixture to be reconstituted simultaneously with the injection.

[0039] In accordance with the present invention, the means for collapsing the two component storage chambers is integrated into the syringe itself, thereby achieving this without the need for other devices on the syringe itself.

[0040] Such a solution not only simplifies the reconstitution and injection operations but also saves on the mold and manufacturing costs of separate pressing and reconstitution means. In particular, the device according to the invention provides the operator or nurse with a similar or better sensitivity to needle insertion compared to the sensation provided by a conventional syringe through which the mixture to be injected is aspirated.

[0041] Although preferred embodiments and possible variations of the present invention have been outlined above, it should be understood that those skilled in the art can make modifications and changes without departing from the scope of protection thereof, as defined in the appended claims.

Claims

1. A device (100) for injecting a reconstitutable mixture, comprising: a first storage chamber (40) for a first component of said mixture; at least one second storage chamber (30) for a second component of said mixture; a first mechanical and fluid connection means (43, 33) between the first storage chamber (40) and the second storage chamber (30); second mechanical and fluid connection means (20) between said second storage chamber (30) and the injection needle (10); Equipped with the first storage chamber (40) comprises, along the mixing direction (y), a first upper surface (41) and a first lower surface (42), the first upper surface (41) and the first lower surface (42) being conical or frustoconical and having substantially the same axis of symmetry (S) and a common bottom periphery (44); the first upper surface (41) and the first lower surface (42) extend in opposite directions along the axis of symmetry (S) and form a non-zero angle β with the common base surface (44); the second storage chamber (30) comprises, along the mixing direction (y), a second upper surface (31) and a second lower surface (32), the second upper surface (31) and the second lower surface (32) being conical or frustoconical and having substantially the same axis of symmetry (S) and a common bottom periphery (34); the second upper surface (31) and the second lower surface (32) extend in opposite directions along the axis of symmetry (S) and form a non-zero angle α with the common base; the first lower surface (42) and the second lower surface (32) are independently deformable by compression; the first mechanical and fluid connection means (43, 33) comprises an outlet neck of the first storage chamber (40) and an inlet neck of the second storage chamber (30), the outlet neck and the inlet neck being connected to form a single fluidly connecting duct; the single fluid connecting duct maintains the first lower surface (42) and the second lower surface (32) apart by a distance greater than the cross section of a finger; the first lower surface (42) and the second lower surface (32) are made of an inelastically deformable material; the inelastically deformable material allows the first lower surface (42) and the second lower surface (32) to be completely crushed against the first upper surface (41) and the second upper surface (31), respectively; Apparatus (100).

2. the first mechanical and fluid connection means (43, 33) comprises a filter and / or a valve; The apparatus (100) of claim 1.

3. the first mechanical and fluid connection means (43, 33) comprises a valve configured to allow unidirectional flow of the first component of the mixed liquid; The apparatus (100) of claim 2.

4. The first upper surface (41) and the first lower surface (42) are configured as a single piece. An apparatus (100) according to any one of claims 1 to 3.

5. The second upper surface (31) and the second lower surface (32) are configured as a single piece. An apparatus (100) according to any one of claims 1 to 4.

6. 1. An injection kit for injecting a reconstitutable mixture, comprising: A first storage chamber (40) according to any one of claims 1 to 5 and a second storage chamber (30) separated therefrom; a first mechanical and fluid connection means (43, 33) between the first storage chamber (40) and the second storage chamber (30) according to claim 1, the first mechanical and fluid connection means (43, 33) being configured to connect the outlet neck of the first storage chamber (40) and the inlet neck of the second storage chamber (30) to form a single fluidly connected duct; second mechanical and fluid connection means (20) between said second storage chamber (30) and the injection needle (10); the injection needle (10) connectable to the second storage chamber (30) by the second mechanical and fluid connection means (20); An injection kit comprising:

7. the outlet neck of the first storage chamber (40) and the inlet neck of the second storage chamber (30) each comprise a removable, destructible or openable watertight sealing element; The injection kit of claim 6.

8. The removable waterproof sealing element is a peelable partition wall.

8. The injection kit of claim 7.

9. the second mechanical and fluid connection means (20) comprises a removable watertight sealing element; An injection kit according to any one of claims 6 to 8.

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