Equipment, injection kits, and methods for injecting recombinant liquid mixtures
By designing an injection device with a conical receiving chamber and mechanical connection device, the problems of chamber isolation and operational difficulty in the existing technology have been solved, achieving efficient mixing and cost-reduced injection operation.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- OROFINO PHARMACEUTICALS GROUP SRL
- Filing Date
- 2021-09-15
- Publication Date
- 2026-06-30
AI Technical Summary
In existing technologies, it is difficult to maintain a high degree of isolation between the containment chambers of deformable boxes, especially when solid and liquid substances are mixed, which leads to the loss of stability of active ingredients. At the same time, the operation is difficult, and the use of specific tools and equipment is complex and costly.
An injection device is designed, comprising first and second receiving chambers connected by rigid or semi-rigid mechanical and fluid connections. The receiving chambers have upper and lower surfaces in a conical or truncated conical shape, allowing inelastic deformation. The mixture is injected by finger squeezing, simplifying the operation.
It achieves efficient mixing and isolation during injection, reduces mold and equipment costs, simplifies operation, and improves operational sensitivity.
Smart Images
Figure CN116194387B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to a deformable pre-packaged device for injecting liquids. Background Technology
[0002] Currently, sterile powder raw materials are mainly packaged by active ingredient manufacturers in aluminum containers or plastic bags (usually polyethylene-based).
[0003] In order to market these sterile powder raw materials, the manufacturers have stated that each of these raw materials, in addition to maintaining sterility, remains stable in the container or bag used for a certain period of time; in other words, if the powder is stored in such a container or bag, it will not rot within a predetermined period of time.
[0004] The sterile raw materials are sold to the final pharmaceutical manufacturers, who use known techniques to fractionate them, resulting in a final sterile powder product contained in a vial. The vial is accompanied by a solvent.
[0005] The use of expensive materials in vials (glass), compatible materials in sterile powders, and disposable syringes makes the system very expensive overall.
[0006] It is known in the art to use syringes with compartments for containing deformable cartridges made of flexible material containing pharmaceutical substances, which are separated and stored in their respective containment chambers by special yielding partitions before use. An example of such a known device is described in patent document US 2001 / 0047162. Another example of such a known device is described in patent document WO 2017137854 A1.
[0007] However, it has been observed that maintaining a high degree of isolation between the various containment chambers is particularly difficult in existing deformable boxes. This is especially problematic if the containment chambers of the deformable box are filled with dissimilar substances, such as solid and liquid substances, or, for example, two substances, which can lead to a loss of stability of the active ingredients if the two substances accidentally mix together earlier than intended.
[0008] As shown in Figure 1a, the applicant's patent document WO 2020 / 070576 provides a solution through a deformable box P1, which has box bodies P10 and P20, and the deformable box includes (Figure 1a):
[0009] - At least one first receiving chamber P11 of the first component of the injectable solution, wherein the first receiving chamber P11 includes at least one first wall that is deformable by compression;
[0010] - At least one second receiving chamber P21 for a second component of an injectable solution, wherein the second receiving chamber P21 includes at least one second wall that is compressibly deformable to allow the second component to be transported from the second receiving chamber P21 to a first receiving chamber P11, thereby achieving mixing of the first and second components; and
[0011] - Needle P5, which is connected to the first receiving chamber P11.
[0012] As shown in Figure 1b, this device P1 is used in conjunction with a specific tool P200 to deform the chamber, thereby mixing the components and injecting them simultaneously. This involves the production of specific components, thus requiring a considerable investment in molds and materials, and also presents certain difficulties for the operator performing the injection.
[0013] In particular, regarding the difficulty of use, it is not only a matter of squeezing the chamber with a specific tool, but also that the operator or nurse is less sensitive in aligning and inserting the needle compared to the sensitivity that can be obtained with a conventional syringe (when using a conventional syringe, the mixture to be injected is drawn in and the syringe is held with only one hand).
[0014] Document WO 2019 / 246435 relates to a bellows device for discharging liquid substances, the bellows device comprising two chambers that cannot be squeezed separately and are therefore unsuitable for storing and recombining substances composed of two components separately.
[0015] Document WO 2020070577A1 discloses a syringe for injecting a solution contained in a deformable cartridge, the syringe having a separate receiving chamber and a connecting device. Document US 4410323A discloses a disposable pre-dose syringe employing a double-conical shape made of a flexible elastic material (such as rubber or an elastomer). Neither of these documents addresses the technical problem of providing a geometry and a non-elastic deformable material to allow for complete, permanent compression of the chamber, combined with a specific structural finger gap distance to prevent premature activation during operation. Summary of the Invention
[0016] The purpose of this invention is to provide a deformable pre-packaging device for injectable liquids that at least partially solves the problems of the prior art and overcomes its disadvantages.
[0017] This invention relates to a device and a corresponding kit.
[0018] The present invention provides an apparatus for injecting a reconfigurable liquid mixture, the apparatus comprising: a first receiving chamber for a first component of the liquid mixture; at least one second receiving chamber for a second component of the liquid mixture; a first mechanical and fluid connection device located between the first and second receiving chambers; and a second mechanical and fluid connection device located between the second receiving chamber and an injection needle; characterized in that: the first receiving chamber includes a first upper surface and a first lower surface along the direction of mixture injection, the first upper surface and the first lower surface having a conical or truncated conical shape substantially having the same axis of symmetry and a common base; the first upper surface and the first lower surface extend in opposite directions along the axis of symmetry, and the first... A non-zero angle is formed between the upper surface and the first lower surface at a common base; the second receiving chamber includes a second upper surface and a second lower surface along the direction of mixture injection, the second upper surface and the second lower surface being conical or truncated conical in shape having a substantially symmetrical axis and a common base; the second upper surface and the second lower surface extend in opposite directions along the symmetrical axis, and a non-zero angle is formed between the second upper surface and the second lower surface at a common base; the first lower surface and the second lower surface are deformable by compression; and the device is characterized in that: a first mechanical and fluid connection device includes an outlet neck of the first receiving chamber and an inlet neck of the second receiving chamber, the outlet neck and the inlet neck being connected to form a single fluid connection conduit; and the single fluid connection conduit keeps the first lower surface and the second lower surface at a distance configured to be greater than the cross-section of a finger.
[0019] The present invention provides an injection kit for injecting reconfigurable liquid mixtures, the injection kit comprising: the device as described above; and an injection needle, wherein a second mechanical and fluid connection is located between a second receiving chamber and the injection needle, wherein the injection needle is connectable to the second receiving chamber via the second mechanical and fluid connection.
[0020] The present invention provides a method for recombining a recombinable liquid mixture and discharging the liquid mixture from an injection needle, the method comprising the following sequential steps: providing the device as described above; placing two fingers on a first upper surface and abutting a thumb against a first lower surface; bringing the thumb closer to the two fingers and pressing the first lower surface against the first upper surface; placing the two fingers on a second upper surface and abutting a thumb against the first lower surface; and bringing the thumb closer to the two fingers and pressing the second lower surface against the second upper surface. Attached Figure Description
[0021] The invention will now be described by way of non-limiting examples, with particular reference to the figures in the accompanying drawings, in which:
[0022] - Figures 1a and 1b show a reconstitution and injection device according to the prior art.
[0023] - Figure 2 A vertical cross-sectional view of an embodiment of the present invention is shown;
[0024] - Figures 3a to 3d It shows Figure 2 The use of equipment in continuous steps;
[0025] - Figures 4a to 4d It shows that it is in the same position as Figures 3a to 3d The same equipment in the same steps, but not shown in cross-section. Detailed Implementation
[0026] It is worth noting that, without limiting the technical concept of the present invention, elements of the different embodiments described below can be combined to provide other embodiments, as will be readily understood by those skilled in the art from the description.
[0027] Regarding details not described, such as secondary elements commonly used in similar solutions in the prior art, this specification also refers to embodiments of the prior art.
[0028] When introducing a component, it is always understood that there can be "at least one" or "one or more".
[0029] When a list of elements or features is given in this specification, it should be understood that, according to the invention, such elements are considered to "comprise" or, alternatively, "compose of" such elements.
[0030] When referring to "up" and "down," the reference is taken to the next position along the axis to be specified. Specifically, "down" refers to a position farther from the liquid outlet of the containing element, while "up" refers to a position closer to the liquid outlet of the containing element.
[0031] Example
[0032] Reference Figure 2 In an embodiment, the injection device 100 of the present invention includes:
[0033] - First receiving chamber 40, the first receiving chamber being used for a first component of the liquid mixture to be injected;
[0034] - Second receiving chamber 30, which is used for a second component of the liquid mixture to be injected (e.g., in powder form, shown in dotted lines in the figures).
[0035] The two containment chambers are fluidly connected by (rigid or semi-rigid) mechanical and fluid connection means 33 and 43.
[0036] More specifically, this (first) mechanical and fluid connection device may consist of a rigid or semi-rigid tubular outlet element (or “neck”) 43 and a tubular inlet element 33, the tubular outlet element being connected to (or integrally formed with) a first receiving chamber 40, and the tubular inlet element being connected to (or integrally formed with) a second receiving chamber 30.
[0037] Optionally, a one-way valve may be added to one of the tubular elements 33 or 43 to allow liquid to pass through the first receiving chamber 40 and retain the liquid in the second receiving chamber 30.
[0038] The tubular outlet element 43 and the tubular inlet element 33 are provided with a suitable mutual mechanical coupling device (not shown), which is preferably watertight (no liquid leakage). The tubular elements 33 and 43 can have any cross-section, as long as they can be fluidly connected in a watertight manner. When the first and second receiving chambers are separately disposed in an injection kit (optionally, the injection kit also includes a needle, which may incorporate other means of administering or discharging the mixture, such as a tube), the tubular element may include a breakable, openable, or removable watertight sealing element, such as a peelable separator.
[0039] The second receiving chamber also includes a tubular outlet element 20 (also referred to as the "second mechanical and fluid connection device"), which is configured such that the injection needle 10 can be secured thereto (in a watertight manner, i.e., not in communication with external fluids). When the second receiving chamber is disposed in the above-described kit, the tubular outlet element (or the second mechanical and fluid connection device) is provided with a removable watertight sealing element, such as a peelable partition.
[0040] As mentioned, the first receiving chamber 40 and the second receiving chamber 30 are configured such that tubular elements 33 and 43 can be stored separately, thus the tubular elements are separable (see [link]). Figure 3a and Figure 4a And they are joined together when injection is to be performed. The combination of tubular elements 33 and 43 can be done in any known manner (e.g., by means of threads and / or a ruptureable membrane).
[0041] One or both of the tubular elements 33 and 43 may include filters and / or valves, for example, valves suitable for allowing unidirectional flow of the first component of the liquid mixture.
[0042] The first mechanical and fluid connection device 43, 33 includes an outlet neck of the first receiving chamber 40 and an inlet neck of the second receiving chamber 30, the outlet neck and the inlet neck being connected to form a single fluid connection conduit.
[0043] The single fluid connection conduit maintains the first lower surface 42 and the second lower surface 32 at a distance configured to be larger than the cross-section of a finger. The cross-section of a finger can be normalized to a size that includes the cross-sectional size of all or most people's fingers.
[0044] The first receiving chamber 40 preferably has a rhomboid or conical cross-section, or a truncated conical cross-section, in a vertical section (the xy plane of the plate). For example, in the first receiving chamber 40, the angle β between the first upper surface 41 and the first lower surface 42 (on one side and the other side of the rhomboid along the y-direction) has a predetermined (non-zero) value before the device is used. The same applies to the lower tip angle γ (the vertex 45 of the cone) between the two first lower surfaces 42 (on one side and the other side of the rhomboid along the x-direction), where this angle has a predetermined (non-zero) value before the syringe 100 is used. In this case, since the tubular outlet element 43 is fixed in the position of this vertex, the upper tip angle (along the y-direction) may not exist. In fact, since a flat or other shaped portion that a thumb will push on can be formed, the lower tip may also not exist, as described below.
[0045] The second receiving chamber 30 also has a rhomboid shape, in which case the angle α between the second upper surface 31 and the second lower surface 32 (on one side and the other side of the rhombus along the y-direction) has a predetermined value before the device is used. Since the tubular inlet element 33 and the tubular outlet element 20 are fixed in such vertex positions, in this case, the lower or upper apex angle may not exist.
[0046] As will be understood above, the shape of the receiving chamber extends in a circular manner along the axis of symmetry S (in the y direction) of the injection device 100 in the volume device, that is, the cross section is rotated 180° (or each corresponding upper and lower surface is rotated 360°) to obtain the volume of the receiving chamber, thereby obtaining an overall shape that corresponds to the combination of two cones (or truncated cones, etc.) with opposite vertices along the common base 44 or 34.
[0047] Furthermore, the surface obtained from the aforementioned rotation does not necessarily have a perfect conical shape, but can be more or less circular, as this does not significantly alter its function.
[0048] In fact, the biconical shape (with a rhomboid or similar cross-section) has a very special function, namely, it allows for... Figures 3a to 3d and Figures 4a to 4d The steps shown (but not limited to) involve squeezing the receiving chamber with your fingers.
[0049] Specifically, according to an embodiment of the invention, after the first receiving chamber 40 and the second receiving chamber 30 are mechanically and fluidly engaged ( Figure 3b and Figure 4b The operator (or nurse) administering parenteral (or other) medication must place the index and middle fingers (or two fingers other than the thumb) of their hand over the first receiving chamber 40 (on the first upper surface 41) while simultaneously pressing the lower surface of the first receiving chamber (first lower surface 42, also see the arrow in the figure) with the thumb until the lower surface presses against the upper surface, such that angle γ is approximately equal to 180°-γ, thereby allowing the liquid component of the first receiving chamber to enter the second receiving chamber. Because the material of the first receiving chamber 40 is inelastically deformable (deformable by compression), this compression will persist even after the push between the index and middle fingers on one side and the thumb on the other side is released. This will allow ( Figure 3d / Figure 4d The index and middle fingers (or the two fingers other than the thumb) are then placed back on the upper surface of the second receiving chamber 30, i.e., back on the second upper surface 31 in the cross-section, while the thumb is able to continue pushing in the same position as before. Similar to the previous steps, the lower surface of the second receiving chamber 30 (the second lower surface 32 in the cross-section) is pressed against (see the arrow in the figure) the corresponding upper surface (the second upper surface 31 in the cross-section). Again, the material used here will allow for inelastic deformation to ensure the safety of the injection.
[0050] According to one aspect of the invention, the first lower surface 42 and the second lower surface 32 in the device 100 are made of a non-elastically deformable material. In particular, the non-elastically deformable material allows the first lower surface 42 and the second lower surface 32 to be fully pressed against the first upper surface 41 and the second upper surface 31, respectively, during the various steps of recombination and discharge of the mixture. The deformability of each chamber 40 and 30 is thus ensured.
[0051] exist Figure 3c and Figure 4c After the steps in the first or second chamber, or after the two components in the two receiving chambers have been recombined in the first receiving chamber, the needle 10 of the injection device 100 can be conveniently introduced into the body to receive the drug. Clearly, the corresponding initial filling (and therefore the dimensions) of the two receiving chambers will make the entire operation possible.
[0052] According to one aspect of the present invention, a method for recombining a recombinable liquid mixture and expelling it from an injection needle is provided, the method comprising the following sequential steps:
[0053] - Provide an apparatus according to the invention;
[0054] - Place two fingers on the first upper surface 41 and place the thumb against the first lower surface 42;
[0055] - Bring the thumb closer to the two fingers and press the first lower surface 42 against the first upper surface 41;
[0056] - Place two fingers on the second upper surface 31 and press your thumb against the first lower surface 42; and
[0057] - Bring the thumb closer to the two fingers and press the second lower surface 32 against the second upper surface 31.
[0058] Advantages of the present invention
[0059] With the solution of the present invention, the two components of the mixture to be injected can be stored in two separate connectable devices, and the syringe and the mixture can be reassembled during injection.
[0060] With this invention, it can be done without using any device other than the syringe itself, because the device for compressing the two components into the receiving chamber is integrated into the syringe itself.
[0061] This solution allows for savings in mold costs and the production costs of separate extrusion and recombination devices, and simplifies recombination and injection operations. In particular, using the device of this invention, the operator or nurse will have needle pointing and insertion sensitivity similar to or superior to that obtained with a conventional syringe (in which the mixture to be injected is drawn into the conventional syringe).
[0062] Preferred embodiments and possible variations of the present invention have been outlined above; however, it will be understood that modifications and alterations may be made by those skilled in the art without departing from the scope of protection as defined in the appended claims.
Claims
1. An apparatus (100) for injecting recombinant liquid mixtures, the apparatus comprising: - A first receiving chamber (40), the first receiving chamber being used for a first component of the liquid mixture; - At least one second containment chamber (30), the at least one second containment chamber being used for a second component of the liquid mixture; - A first mechanical and fluid connection device (43, 33) is located between the first receiving chamber (40) and the second receiving chamber (30); - A second mechanical and fluid connection device (20) is located between the second receiving chamber (30) and the injection needle (10); The device (100) is characterized by: - The first receiving chamber (40) includes a first upper surface (41) and a first lower surface (42) along the injection direction (y) of the mixture, the first upper surface and the first lower surface being a conical or truncated conical shape having the same axis of symmetry (S) and a common base (44); - The first upper surface (41) and the first lower surface (42) extend in opposite directions along the axis of symmetry (S), and a non-zero angle (β) is formed between the first upper surface and the first lower surface at the common base (44). - The second receiving chamber (30) includes a second upper surface (31) and a second lower surface (32) along the injection direction (y) of the mixture, the second upper surface and the second lower surface being conical or truncated conical in shape having the axis of symmetry (S) and a common base (34); - The second upper surface (31) and the second lower surface (32) extend in opposite directions along the axis of symmetry (S), and a non-zero angle (α) is formed between the second upper surface and the second lower surface at the common base (34). - The first lower surface (42) and the second lower surface (32) are deformable by compression; Furthermore, the characteristics of the device are as follows: - The first mechanical and fluid connection device (43, 33) includes an outlet neck of the first receiving chamber (40) and an inlet neck of the second receiving chamber (30), the outlet neck and the inlet neck being connected to form a single fluid connection conduit; and - The single fluid connection conduit keeps the first lower surface (42) and the second lower surface (32) at a distance configured to be greater than the cross-section of a finger. in: - The first lower surface (42) and the second lower surface (32) are made of a non-elastically deformable material; - The inelastically deformable material allows the first lower surface (42) and the second lower surface (32) to be fully pressed against the first upper surface (41) and the second upper surface (31), respectively.
2. The device (100) according to claim 1, wherein, The first mechanical and fluid connection device (43, 33) includes a filter and / or a valve.
3. The device (100) according to claim 2, wherein, The first mechanical and fluid connection device (43, 33) includes a valve adapted to allow unidirectional flow of the first component of the liquid mixture.
4. The device (100) according to any one of claims 1 to 3, wherein, The first upper surface (41) and the first lower surface (42) are formed as one unit.
5. The device (100) according to any one of claims 1 to 3, wherein, The second upper surface (31) and the second lower surface (32) are formed as one unit.
6. An injection kit for injecting recombinant liquid mixtures, the injection kit comprising: - The device (100) according to any one of claims 1 to 5; as well as - Injection needle (10), the second mechanical and fluid connection device being located between the second receiving chamber (30) and the injection needle (10); - wherein the injection needle is connected to the second receiving chamber (30) via the second mechanical and fluid connection device (20).
7. The injection kit according to claim 6, wherein, The outlet neck of the first receiving chamber (40) and the inlet neck of the second receiving chamber (30) each include a removable, breakable, or openable watertight sealing element.
8. The injection kit according to claim 7, wherein, The removable watertight sealing element is a peelable separator.
9. The injection kit according to any one of claims 6 to 8, wherein, The second mechanical and fluid connection device (20) includes a removable water-sealing element.