Pre-filled containers, usage instructions, and related production methods

Abstract

The present invention relates to a container (1) pre-filled or pre-fillable with one or more substances, such as medical fluids, the container comprising: a compressible actuated compartment (2) for containing the one or more substances; a dispensing compartment (3) comprising a first portion (31) and a second portion (32), the first portion being equipped with at least one dispensing member (311, 312, 314) for the one or more substances, wherein the second portion (32) of the dispensing compartment (3) and the actuated compartment (2) are hydrodynamically connected; and an actuator element (4) disposed within the container (1). The invention also relates to a method for dispensing at least one substance through the container (1), and a method for manufacturing the container (1).

Description

Technical Field

[0001] This invention relates to pre-filled containers, methods of use, and related production methods.

[0002] More specifically, the present invention relates to a pre-filled container that allows the contents of at least two compartments to be mixed during dispensing, thereby ensuring the segregation of the substances to be dispensed until actual use.

[0003] Furthermore, the invention relates to a pre-filled container that is easy to use while ensuring accurate release of contents and minimizing potential contamination.

[0004] This system enables the production of products with different uses and purposes under the same principles according to the present invention. Background Technology

[0005] As is well known, spray devices for dispensing substances are widely used in the medical field, especially when the substances to be dispensed must be sterile and / or hazardous, or even when used for particularly expensive substances or substances that are permitted to be dispensed in specific doses.

[0006] One problem with the aforementioned types of prefilled containers is that they consist of multiple parts that need to be assembled, often metal parts, which significantly increases their cost.

[0007] Another problem with medical nebulizers is the difficulty in producing drug droplets of a consistent size throughout the three stages of drug use (i.e., droplet formation, full development, and dissipation).

[0008] Another common use of these containers is for prefilling syringes.

[0009] Currently, there is no affordable aseptic system on the market that allows needles and products to remain separate and sterile until actuation during long-term transportation and storage.

[0010] Furthermore, there is currently no known affordable institution in this field that could prevent the reuse of containers after the initial product distribution, if needed.

[0011] Purpose of the invention

[0012] Therefore, in the above-mentioned requirements, the main objective of the present invention is to provide a pre-filled container, such as a pre-filled container for one or more given drugs, which can overcome the above-mentioned technical defects, and in particular, produce a pre-filled container that can be used safely regardless of its shape.

[0013] Another object of the present invention is to produce a pre-filled container capable of dispensing droplets of medicine like a sprayer.

[0014] Furthermore, one object of the present invention is to produce a pre-filled container that, if necessary, ensures that the user or a third party cannot reuse it.

[0015] Another object of the present invention is to produce a prefilled container that is suitable for safe use in several respects, including hygiene, accuracy of drug release, and inherent safety for patients and operators.

[0016] Furthermore, one object of the present invention is to produce a prefilled container suitable for producing standard syringes, vials, or other medical or non-medical containers, etc.

[0017] Another object of the present invention is to produce a prefilled container that is functional, quick to implement, and sufficiently precise in releasing the drug.

[0018] Therefore, the object of this invention is to produce an effective product in terms of cost, ease of production, use, and safety, while also ensuring a sterile state before use.

[0019] These and other objectives are achieved by the pre-filled container according to the invention, which will be better explained later in this specification. Summary of the Invention

[0020] Therefore, the object of the present invention is to provide a container pre-filled or capable of being pre-filled with one or more substances (such as medical fluids), wherein the container may include a compressible actuated compartment for containing the one or more substances, the dispensing compartment comprising a first part and a second part, the first part being equipped with at least one dispensing member for dispensing the substances contained therein, and the dispensing compartment and the actuated compartment being hydrodynamically connected at the second part; the container also includes a movable actuator element adapted to move from a closed position to an open position, in which the actuator element hermetically and / or hydrodynamically isolates the contents of the actuated compartment from the contents of the dispensing compartment, and in the open position, it allows the actuated compartment to communicate with the dispensing compartment, thereby allowing the substances to be dispensed through the dispensing member.

[0021] In a preferred embodiment of the invention, when the actuation compartment is compressed, the actuator element moves from the closed position to the open position.

[0022] Furthermore, the actuation compartment is configured such that when squeezed, the actuation compartment interferes with the actuator element to allow it to move.

[0023] In addition, the actuator element includes a conical closure portion configured to engage between the actuation compartment and the dispensing compartment of the container.

[0024] In addition, the actuator element may include a head and a rod, the bottom of which is connected to the closed portion, and the rod is connected to the bottom relative to the closed portion itself; when the actuator element is in the closed position, the rod is accommodated in the actuation compartment.

[0025] Preferably, in a preferred embodiment, the rod portion of the actuator element may be of an elastic and / or flexible type and may have a generally rhomboid spring shape for ease of use.

[0026] In addition, the head of the actuator element may include one or more receiving portions arranged above the closed portion.

[0027] In a preferred embodiment, the head may further include a sliding crown provided with one or more mixing devices arranged above the receiving portion of the actuator element and larger than the closed portion.

[0028] Specifically, the hybrid device described above can be selected from at least one of the following types:

[0029] - Through hole; and / or

[0030] - A hook, which is acquired on the outer periphery of the sliding crown itself; and / or

[0031] - A lateral incision, obtained on the periphery of the sliding coronal portion; and / or

[0032] - Triangular pieces; and / or

[0033] - Cross-shaped component.

[0034] Furthermore, in a further preferred embodiment, the head of the actuator element may include one or more sliding crowns located between the receiving portion and the aforementioned sliding crowns.

[0035] Furthermore, the head of the actuator element may include a release portion arranged on top to improve the mixing of the substance to be dispensed from the container, which is an object of the present invention.

[0036] In a preferred variant, the head of the actuator element may have a locking region, which may be made of different materials and have different shapes, to block the needle and / or other dispensing attachments that may be attached to the container, thereby preventing reuse.

[0037] Furthermore, the container according to the invention may include a sealing insert disposed therein, the sealing insert having a generally frustoconical shape and having: one or more protrusions or peripheral recesses along the associated wall to facilitate anchoring of the sealing insert at a second portion of the dispensing compartment; and a converging portion disposed between the actuation compartment and the dispensing compartment, wherein, in this embodiment, the actuator element is sealingly engaged with the converging portion when in a closed position; the sealing insert and the actuator element can be assembled and tested before being inserted into the container, which is an object of the invention.

[0038] In other preferred embodiments, the sealing insert may include a pair of operating levers arranged in the actuation compartment, each operating lever being fixed to the outer surface of the converging portion or the outer surface of the lateral surface, and may further include hook-shaped release portions such that when they are actuated and thus squeeze the actuation compartment of the container, they interfere with the actuator element, causing the actuator element to disengage from the converging portion of the sealing insert and causing the actuator element to move from the closed position to the open position.

[0039] In addition, the sealing insert may include a triggering device connected to the sealing insert via a tab including a thrust member, wherein the triggering device moves in such a way that the sealing area of ​​the actuator element disengages from the converging portion of the sealing insert when the actuation compartment is compressed.

[0040] In other preferred but non-limiting embodiments, the actuation compartment of the container for the purposes of this invention may have a spherical or elliptical shape, especially to facilitate its compression.

[0041] In addition, the actuation compartment may include one or more bellows adapted to promote its compressibility, especially during the steps of using the aforementioned container.

[0042] In addition, the actuation compartment of the container may have a shaped portion adapted to receive the free end of the rod of the actuator element in order to guide and facilitate the translational movement of the actuator element along its axis.

[0043] In addition, the dispensing component may include a nozzle, which may be disposed on its top or on the side wall of the dispensing compartment;

[0044] A pair of nozzles, preferably arranged at a certain distance from each other, so as to dispense the substance into the nostrils of the user's nose.

[0045] In a preferred embodiment, the release portion on the head of the actuator element may be made of a soft material, such as rubber and similar materials, to allow the release portion to be inserted into the base of an insert located in the first part of the dispensing compartment or in the nozzle, thereby avoiding possible reuse of the container, especially when the actuator element is in the open position.

[0046] The container according to the invention can be used to dispense the at least one substance contained in the actuation compartment and / or dispensing compartment by disengaging the actuator element to hydrodynamically connect the compartment until a predetermined threshold is reached; and by dispensing the at least one substance by dispensing the at least one substance through the at least one dispensing member described above.

[0047] Furthermore, the contents of the actuation compartment can be mixed with the contents of the dispensing compartment after the actuator element is disengaged and before the dispensing member is opened.

[0048] Specifically, the mixing is performed by the aforementioned mixing device through the sliding crown of the actuator element.

[0049] Finally, the container according to the purpose of the invention can be made as follows:

[0050] By increasing the temperature of the container, the container can be made to work;

[0051] By inserting the actuator element into the container; and

[0052] By centering and engaging the actuator element between the actuation compartment and the distribution compartment.

[0053] In addition, during the manufacturing steps of the container described above, there may be a step of inserting the sealing element together with the actuator element into the container, the actuator element being pre-assembled within the sealing element itself; this occurs before the sealing insert is centered and engaged in the container, and before the container is closed once it is made.

[0054] In a preferred embodiment, the actuation compartment and / or the distribution compartment are molded using a "blow fill seal" process. Attached Figure Description

[0055] Further features and advantages of the prefilled container according to the invention will become more apparent from the following description (which mentions preferred but non-limiting exemplary embodiments) and the accompanying drawings, in which:

[0056] Figure 1A A perspective view of a first embodiment of a pre-filled container according to the present invention is shown;

[0057] Figure 1B It shows Figure 1A The pre-filled container is in the front cross-sectional view of the closed configuration;

[0058] Figure 1C It shows the open configuration. Figure 1A A front view of the cross-section of the pre-filled container;

[0059] Figure 1DThis shows an intermediate configuration in use. Figure 1A A front view of the cross-section of the pre-filled container;

[0060] Figure 1E The final use configuration is shown. Figure 1A Pre-filled containers;

[0061] Figure 2A An isometric view is shown of a first embodiment of an actuator element for a pre-filled container according to the purpose of the invention;

[0062] Figure 2B An isometric view is shown of a second embodiment of an actuator element for a pre-filled container according to the purpose of the invention;

[0063] Figure 2C An isometric view of a third embodiment of an actuator element for a pre-filled container according to the purpose of the invention is shown;

[0064] Figure 2D An isometric view is shown of a fourth embodiment of the actuator element of a prefilled container according to the purpose of the invention;

[0065] Figure 2E An isometric view of a fifth embodiment of an actuator element for a pre-filled container according to the purpose of the invention is shown;

[0066] Figure 3A This is a cross-sectional front view of a first embodiment of a sealing insert connected to an actuator element;

[0067] Figure 3B A cross-sectional front view of a second embodiment of a pre-filled container according to the present invention is shown, wherein a sealing insert and an actuator element are coupled to the container in a possible closed configuration;

[0068] Figure 3C It shows Figure 3B The pre-filled container is in a cross-sectional front view of the possible final use configuration;

[0069] Figure 4 A cross-sectional front view of a third embodiment of a prefilled container according to the present invention is schematically shown;

[0070] Figure 5A An isometric view is shown of a sixth embodiment of the actuator element of the prefilled container for the purposes of this invention;

[0071] Figure 5B A cross-sectional front view of a fourth embodiment of a prefilled container according to the present invention is shown, in a possible closed configuration;

[0072] Figure 5C It shows Figure 5B A cross-sectional front view of a pre-filled container, showing its possible open and intermediate usage configurations;

[0073] Figure 5D It shows Figure 5B A cross-sectional front view of a pre-filled container in its possible final use configuration;

[0074] Figure 6A A cross-section of a second embodiment of the sealing insert for an actuator element of a fifth embodiment of a prefilled container according to the invention is shown schematically and frontally.

[0075] Figure 6B The illustration schematically and positively shows the possible usage configurations for... Figure 6A The cross-section of the pre-filled container and the sealing insert of the actuator element;

[0076] Figure 7A A cross-sectional front view of a sixth embodiment of a pre-filled container, which is the subject of the present invention, is shown;

[0077] Figure 7B A cross-sectional front view of a seventh embodiment of a prefilled container according to the present invention is shown;

[0078] Figure 7C A cross-sectional front view of an eighth embodiment of a prefilled container according to the present invention is shown;

[0079] Figure 7D A cross-sectional front view of a ninth embodiment of a prefilled container according to the present invention is shown;

[0080] Figure 7E A cross-sectional front view of a tenth embodiment of a prefilled container according to the present invention is shown;

[0081] Figure 7F A cross-sectional front view of an eleventh embodiment of a prefilled container according to the present invention is shown;

[0082] Figures 8A to 8E The specific steps of using the pre-filled container, which is the object of the present invention, are illustrated schematically. Detailed Implementation

[0083] Figures 1A to 1D A first embodiment of the pre-filled container is shown, generally indicated by reference numeral 1 in the accompanying drawings.

[0084] The container 1 includes an actuation compartment 2, a distribution compartment 3, and an actuator element 4.

[0085] The actuation compartment 2 is manufactured so that it can be squeezed even by pressure from the user's finger, which will be explained in more detail below.

[0086] In the considered embodiment, the actuation compartment 2 has a basic spherical shape; however, different shapes or configurations may be provided in other embodiments.

[0087] The aforementioned actuation compartment 2 includes a weakened bellows region 21 located in its intermediate region, so as to compress the actuation compartment 2 itself during compression.

[0088] Advantageously, the actuating compartment 2 also has a shaped portion 22 on its base, which is formed as a recess on the relevant inner surface, such that when the actuating compartment 2 is squeezed to dispense the substance contained therein, the shaped portion 2 facilitates the use of the container 1 and thus facilitates the function of the container 1, as explained further below.

[0089] The aforementioned actuation chamber 2 can be molded using a blow-fill seal (BFS) process. Specifically, in a preferred embodiment, the actuation chamber 2 is made of a substantially elastic material, such as plastic or rubber, to facilitate its compression as described above. Figure 1D and Figure 1E As shown. Therefore, when the user squeezes the actuation chamber 2, a portion of the actuation chamber folds substantially into itself in the squeezing direction.

[0090] Typically, for sterile reasons, the actuation compartment 2 is pre-filled with at least one substance or mixture to be dispensed.

[0091] Note that multiple substances or mixtures of substances (such as air and / or other gases) to be dispensed can also be introduced into the actuation chamber 2 simultaneously.

[0092] The dispensing compartment 3 in this embodiment has a basic tubular geometry, but other geometries and shapes may also be used, as shown in the embodiments below. Furthermore, the dispensing compartment 3 may also be made of a basically elastic and / or plastic material and may also be molded using the BFS process.

[0093] In addition, the dispensing compartment 3 may be pre-filled with at least one substance or mixture, such as air, similar to the actuation compartment 2, as shown below, which dispenses from the container 1.

[0094] The dispensing compartment 3 includes a first portion 31 and a second portion 32. The first portion 31 is equipped with at least one dispensing member 311, i.e., a nozzle in the considered embodiment, which can be advantageously connected to an accessory, such as a needle, for dispensing the substance contained in the container 1. The second portion 32 includes a recessed section 321, at which the dispensing compartment 3 itself is connected to the actuation compartment 2.

[0095] The second part 32 of the dispensing compartment 3 may have one or more forming parts 322, which are adapted to improve the mixing of the liquid.

[0096] In particular, when manufacturing the dispensing compartment 3, the groove section 321 is also molded and calibrated by inserting the actuator element 4 into the container 1 through the BFS molding process described above.

[0097] More specifically, when the material forming the dispensing compartment 3 (as described, for example, a plastic type) is still malleable due to the temperature of the ongoing BFS process, the actuator element 4 is inserted and thus acts as a mold for calibrating the groove section 321.

[0098] Typically, during the container manufacturing process, actuator element 4 can be inserted before or after the mold closes.

[0099] In an embodiment, actuator element 4 can be inserted in the BFS process before or after mold closure.

[0100] In this way, since the actuator element 4 is complementary to the groove section 321, the actuator element 4 has a better seal therein, thus increasing the degree of isolation between the dispensing compartment 2 and the actuation compartment 3.

[0101] In the considered embodiment, the actuator element 4 is arranged entirely inside the container 1, wherein the actuator element is held in place to subsequently move or deform between a closed position and an open position, as further explained below, particularly in the compression direction of the actuation compartment 2, as further explained below.

[0102] The aforementioned actuator element 4 can be made of, for example, plastic material and / or by molding.

[0103] The actuator element 4 also includes a head 42, the function of which will be described below.

[0104] The head 42 of the actuator element 4 includes a generally conical sealing portion 424 adapted to engage with a recessed section 321 to seal and isolate the contents of the actuation chamber 2 and the dispensing chamber 3 accordingly.

[0105] Furthermore, the actuator element 4 also includes a rod portion 41 having a generally elongated shape, which is connected below the sealing portion 424. In the considered embodiment, when the actuator element 4 is in the closed position, the rod portion 41 is arranged inside the actuation compartment 2.

[0106] In particular, the free end of the rod portion 41 of the actuator element 4 is arranged at the shaped portion 22 of the actuation compartment 2 to facilitate the use of the container 1 during the dispensing of at least one of the substances.

[0107] When the actuation chamber 2 is squeezed to dispense the substance contained in the actuation chamber 2 itself, the aforementioned forming portion 22 intercepts and receives the free end of the rod portion 41.

[0108] The lever 41 allows the compressive force applied to the actuation chamber 2 to be transmitted to the actuator element 4 itself. Furthermore, the length of the lever 41 determines the pressure within the actuation chamber 2 when the actuator element 4 disengages from the grooved section 321 of the distribution chamber 3 due to the compressive force.

[0109] In this embodiment, the head 42, sealing region 424, and rod 41 of actuator element 4 are made as a single component, thus being molded and manufactured simultaneously, or they are of a pre-assembled type. In other embodiments not shown in the figures, the head 42, sealing region 424, and rod 41 may be molded separately using different materials, and are therefore considered as different components to be assembled before or after insertion.

[0110] according to Figure 1B The operation of the pre-filled container 1 in the illustrated embodiment is as follows.

[0111] Before using the pre-filled container 1, the actuator element 4 is in the closed position. Figure 1B , Figure 1C In this configuration, portion 424 is connected to the pre-filled container 1, thus fully engaging the recessed portion 321 and thereby sealingly closing the hydrodynamic connection between the actuation compartment 2 and the dispensing compartment 3 to isolate their respective contents.

[0112] Furthermore, in the considered embodiments, particularly refer to Figure 1B and Figure 1C The dispensing compartment 3 has a removable closure seal 315, for example, with a screw mechanism, which is adapted to keep the dispensing compartment 3 and its contents isolated from the outside atmosphere until the pre-filled container 1 is used.

[0113] exist Figure 1C In the case of container 1 being in an open configuration, the sealing element 315 is removed, and the dispensing nozzle 311 is exposed.

[0114] Subsequently, as exemplarily Figure 1D As shown, the user grasps the actuation compartment 2 with his / her fingers and squeezes the actuation compartment in direction L until the surface of part 22 of the actuation compartment 2 contacts the lower part of the rod 41; at this time, the required pressure for dispensing is generated inside the container 2.

[0115] Next, while continuing to press the compartment 2 according to direction L, the user begins to move the rod 41 of the actuator element 4 by disengaging part 424 of the actuator element 4 from the groove section 321, as shown. Figure 1E As shown, the actuator element 4 is moved from the closed position to the open position, thereby hydrodynamically connecting the actuation chamber 2 and the dispensing chamber 3, and thus mixing the substance / mixture in the actuation chamber 2 with the product contained in the dispensing chamber 3.

[0116] Furthermore, the substance or mixture contained in the shown compartment thus exits the nozzle 311 at a considerable pressure, making it suitable for application, for example, as a sprayer.

[0117] Figure 2A A first embodiment of actuator element 4 is shown.

[0118] Specifically, this actuator element 4 includes a closed portion 424 connected to the rod portion 41 and the head 42, which, when the actuator element 4 is in the closed position, engages with the second portion 32 of the dispensing compartment 3 at the recessed section 321.

[0119] The head 42 of this actuator element includes a sliding crown 422, for example, which is circular in shape and larger than the closed portion 424, and includes a mixing device, in this case, a through-hole 4221 adapted to mix the substances to be dispensed and sprayed.

[0120] like Figure 1D and Figure 1E As shown, the sliding crown 422 also serves as a guide for the actuator element 4 during its movement.

[0121] The head 42 of the actuator element 4 also includes a generally cylindrical region 421 that allows the substance to be dispensed to be placed between the sliding crown and the closed portion 424, thereby improving its mixing.

[0122] The head 42 under consideration also includes a release portion 423 disposed above the sliding crown 422 for improving mixing.

[0123] Again, advantageously, the release part 423 and the portion relative to the rod part 41 can be used for conveying the container 1.

[0124] In the above embodiment, the rod portion 41 has a generally cross-shaped cross-section to facilitate the passage of the at least one substance from the actuation chamber 2 to the dispensing chamber 3. As described above, the rod portion 41 is adapted to transmit compressive force from the actuation chamber 2 to the actuator element 4 when the sealing region 424 of the actuator element 4 disengages from the groove section 321 of the container 1, in order to quantitatively dispense the amount of the at least one substance to be dispensed and regulate the pressure within the actuation chamber 2.

[0125] Figure 2BA second embodiment of the actuator element 4 is shown, wherein the sliding crown 422 does not have a mixing hole, and the rod 41 has a cylindrical shape, for example, to make the rod 41 of the actuator element 4 have greater rigidity.

[0126] The actuator element 4 in the embodiment described herein is Figures 1A to 1E As described in [the text].

[0127] Figure 2C A third embodiment of the actuator element 4 is shown, wherein the sliding crown 422 has a mixing hook 4222 positioned along the outer periphery of the crown 422 itself, and the mixing hook is adapted to generate turbulence as the substance to be dispensed passes through, thereby improving mixing.

[0128] The rod 41 in the above embodiments is basically the same as that described in the first embodiment, especially in Figure 2A middle.

[0129] Figure 2D A fourth embodiment of actuator element 4 is shown.

[0130] In the considered embodiment, another sliding crown 425 is connected below the sliding crown 422, which is adapted to improve the mixing and dispensing process of the substance from the pre-filled container 1. This other sliding crown 425 is coupled to the portion 421 of the head 42, which in turn is connected to the closure portion 424.

[0131] Similar to the embodiments described above, the closed portion 424 is connected to the rod portion 41 of the actuator element 4.

[0132] Figure 2E A fifth embodiment of this actuator element 4 is shown. The sliding crown 422 has a lateral cutout 4223 to improve the passage of the mixture. A region 425 is provided in the head 42, which may also be made of a different material, such as rubber, which allows the needle or other attachments to be held in place and prevents reuse, as will be explained below.

[0133] Figure 3A A first embodiment of a sealing insert 5 connected to an actuator element is shown.

[0134] In the considered embodiments, particular reference is made to Figure 3B The actuation compartment 2 and the distribution compartment 3 are substantially similar to those described, for example, refer to [reference]. Figures 1A-1E An embodiment of the pre-filled container 1 is shown.

[0135] Dispensing compartment 3 does not include recess 321; in the considered embodiment, the dispensing compartment 3 is not hydrodynamically connected to the actuation compartment 2 because the sealing insert 5 is located between them. In this embodiment, the actuator element 4 moves within the sealing insert 5 (e.g., in a frustoconical shape), which is also located within the prefill container 1, to ensure more controlled and uniform movement of the actuator element 4 during the step of using the prefill container 1.

[0136] The sealing insert 5 may include one or more protrusions or peripheral recesses 52 positioned along the outer surface 53 of the insert to allow for greater anchoring when the sealing insert is inserted into the prefilled container 1 at the portion 32 of the dispensing element 3.

[0137] For example, the sidewall 53 can have a cylindrical or truncated cone shape, such as... Figure 3A and Figure 3B Specifically shown.

[0138] A converging portion 51, arranged between the actuation compartment 2 and the dispensing compartment 3 during use, is provided on the lower edge of the sidewall 53. This converging portion 51 defines a section that separates the areas of the two compartments. The inner surface of the converging portion 51 performs substantially the same function as the recessed section 321, which is present, for example, in the embodiment of the pre-filled container 1 shown in FIG. 1.

[0139] In a preferred embodiment, if desired, the sealing insert 5 can be pre-assembled to the actuator element 4 to allow for a seal check before insertion into the pre-filled container 1.

[0140] If the actuator element 4 is coupled to the sealing insert 5 before being inserted into the container 1, a system that ensures precise calibration of the sealing force between such actuator elements and such sealing inserts can be used to connect them, so as to also ensure accurate separation force.

[0141] like Figure 3C As shown, by the user squeezing the actuation compartment 2 in direction L, the lower wall of the actuation compartment collapses towards the interior of the pre-filled container 1. In other words, in this embodiment, a portion of the actuation compartment 2 changes from recessed to convex. Furthermore, due to the shape and deformability of the actuation compartment 2, the inner walls of the actuation compartment remain adjacent to allow for the dispensing of all the material contained therein, while avoiding any risk of backflow, i.e., the dispensed material partially flowing back into container 1 after the user releases the container. The above configuration effectively prevents the reuse of the pre-filled container 1 and promotes and improves the reliability of dispensing the material or mixture contained in the container.

[0142] Figure 4Another embodiment of the prefilled container 1 is described, wherein the actuator element 4 includes only a head 42 and a tapered portion 424 for engaging with the converging portion 51 of the sealing insert 5.

[0143] In this embodiment, the sealing insert 5 includes a triggering device 54, which is contained within the actuation chamber 2 when the actuator element 4 is in a stationary position. The triggering device 54 includes a thrust member 512.

[0144] During the process of squeezing the actuation chamber 2 along direction L, the contents of the actuation chamber 2 are pressurized.

[0145] As pressure continues to be applied along direction L, the actuation chamber 2 is pushed, and the thrust member 512 of the trigger device 54 moves the head 42 of the actuator element 4, causing the head to disengage from the portion 51 of the sealing insert, and causing the contents of the actuation chamber 2 and the contents of the dispensing chamber 3 to be in dynamic communication, thereby resulting in the dispensing of the mixture at the required pressure.

[0146] Figure 5A A sixth embodiment of actuator element 4 is shown.

[0147] The actuator element 4 has a conical sealing region 424, which, as described above, is adapted to engage the aforementioned groove section 321 in order to seal and isolate the contents of the actuation chamber 2 and the dispensing chamber 3 accordingly.

[0148] In the considered embodiment, the sealing region 424 of the actuator element 4 is connected below the elastic rod portion 411, which has a generally diamond-shaped spring, in this way facilitating or benefiting the user's squeezing process of the actuation compartment 2 itself.

[0149] In particular, in the case considered, the sliding crown 422 of the actuator element 4 has a generally circular surface with a mixing device, specifically a lateral cutout 4223, for improving mixing.

[0150] Figures 5A to 5D The pre-filled container 1 shown has a dispensing compartment 3, which is essentially the dispensing compartment described in the accompanying drawings of the above embodiment. However, in the illustrated embodiment, the actuation compartment 2 has a quadrilateral shape, for example, to allow lateral compression in the direction R shown in the analyzed drawings. The actuation compartment 2 may also take other shapes besides quadrilaterals, as needed.

[0151] As in Figures 5A to 5D As can be verified in detail, the operating mechanism allows the user to laterally compress the actuation chamber 2 in the compression direction R during use.

[0152] During the compression of the actuation compartment 2, its internal pressure increases until, for example, the inner surface pushed by the user's finger begins to press against the rod portion 411, thereby causing the sealing region 424 of the actuator element 4 to disengage from the recessed section 321 of the container 1. After this separation, essentially what has already occurred... Figure 1C The situation described herein refers to the distribution of at least one substance contained in container 1.

[0153] Figure 6A and Figure 6B A second embodiment of the sealing insert 5 is shown, in which the sealing insert is disposed in the pre-filled container 1 in a simplified manner, similar to that in the embodiments described above.

[0154] As shown in the figure, the shuttle 5 has a pair of operating levers 512 connected to the converging portion 51, which are arranged within the actuation compartment 2 of the pre-filled container 1. Each of the operating levers 512 is fixed at one end to the converging portion 51 of the shuttle 5 and includes a hook-shaped release part 513, the function of which will be further described below.

[0155] As with other embodiments, when using pre-filled container 1, it is also necessary to... Figure 6B The arrow indicated by the letter R in the middle squeezes the actuating compartment 2, specifically squeezing the side wall.

[0156] When the pair of operating levers 512 are actuated, each hook-shaped release portion 513 interferes with the base of the sealing region 424 of the actuator element 4, causing it to disengage from the converging portion 51, thereby enabling dynamic communication of the contents of the actuation chamber 2 and the dispensing chamber 3; furthermore, the relative internal pressure is increased by the pressure applied to the side of the actuation chamber 2, causing the same dispensing process as described in the above embodiment to occur when the actuator element 4 disengages from the converging portion 51.

[0157] Figure 7A A sixth embodiment of the pre-filled container 1 is shown.

[0158] In the considered embodiment, in addition to what has been described above, the actuation compartment 2 includes a plurality of weakened bellows regions 211 in a location parallel to its intermediate region, which are adapted to facilitate the extrusion process.

[0159] Figure 7B A seventh embodiment of a prefilled container according to the purpose of the invention is shown, wherein the dispensing compartment 3 includes, in the first part 31, another nozzle 312 in addition to nozzle 311, which is adapted for use, for example, when it is necessary to dispense the at least one substance into the two nostrils of a patient, so as to make the process simpler and more ergonomic.

[0160] Furthermore, in the above embodiments, the actuator element is also Figure 2B The type shown.

[0161] The operation of the pre-filled container 1 according to the aforementioned third embodiment is basically similar to the operation described above. Due to the additional feature, in the step of using the pre-filled container 1, the substance is simultaneously dispensed through two nozzles 311 and 312.

[0162] Figure 7C An eighth embodiment of the prefilled container 1 is shown. The dispensing compartment 3 includes an inclined portion 33 on which a nozzle 311 is located for greater ergonomics, particularly for nasal applications.

[0163] The operation of the pre-filled container 1 according to the second embodiment described above is basically as described above.

[0164] In the step of using container 1, the inclined portion 33 of the dispensing compartment 3 allows the user to place one finger in area 331 and another finger in the area indicated by mark 221 below the actuation compartment 2, thereby facilitating gripping and making gripping and subsequent application easier and more ergonomic.

[0165] Figure 7D A ninth embodiment of the prefilled container 1 is shown, wherein, in addition to the above, particularly in the first embodiment of the container 1, the actuation compartment 2 has a generally elliptical shape and is offset relative to the dispensing compartment 3.

[0166] During use, the offset position of the actuation compartment 2 allows for squeezing by placing two fingers on the areas indicated by reference numerals 222 and 221 within the actuation compartment 2 itself, thus effectively reducing the effort required to dispense the at least one substance from the container 1.

[0167] Figure 7E A tenth embodiment of the pre-filled container 1 is shown. The dispensing compartment 3 includes an additional portion 331 disposed on the side of the dispensing compartment 3 and located at the second portion 31. The additional portion 331 has a nozzle 311, as shown in FIG22A, which, similar to that described above, has a cap 315 adapted to isolate the contents of the container 1 from the atmosphere.

[0168] This design makes the system ergonomic and easy for users to grip, especially suitable for nasal applications.

[0169] The operation of the pre-filled container 1 is the same as that in the above embodiment. In particular, during use, the additional portion 331 of the dispensing compartment 3 allows the user to place a finger on portion 222 of the dispensing element 3 and a finger under the actuation compartment 2 (reference numeral 221), thereby making this particular application easier.

[0170] Figure 7F Eleventh embodiment of container 1 is shown. In this embodiment, the dispensing compartment 3 includes two additional portions 331 positioned laterally relative to the dispensing element 3. A first nozzle 311 and a second nozzle 312 are respectively provided on said additional portions 331, thus improving ergonomics, especially for nasal applications. Grip and Figure 7E The description is essentially the same, so one finger can be positioned in region 221 while another finger can be positioned in region 222. During use, for example, as described above, the substance contained in the pre-filled container 1 is simultaneously dispensed into the patient's nostrils through two nozzles 311 and 312.

[0171] Figures 8A to 8E A prefilled container 1 is described in another embodiment. The prefilled container 1 provides dispensing elements, such as needles 314.

[0172] The use of this type of container is basically the same as that described in Figure 1.

[0173] The actuator element shown is Figure 2E The actuator elements shown are basically the same.

[0174] It should be noted that the container 1 according to the invention can also be prefillable, that is, the substance to be dispensed can be introduced into the actuation compartment 2 or the dispensing compartment 3 after the container 1 itself is manufactured.

[0175] Advantages

[0176] The pre-filled containers described above and illustrated in detail in Figures 1 to 8 have several advantages. In particular, the present invention, conceived in this way, also makes it possible to manufacture disposable pre-filled sterile containers that allow the substance contained therein to be applied in the form of a spray; furthermore, it ensures that:

[0177] -Ease of assembly and use, functionality, and speed;

[0178] -Accuracy of drug release;

[0179] - Compared to known solutions, it offers higher reliability and security;

[0180] - Suitable for holding different types of liquids, therefore suitable for holding drugs / pharmaceuticals;

[0181] - Safety from a pollution perspective;

[0182] - The deterministic requirement that containers are not reusable;

[0183] - The impossibility of counterfeiting products;

[0184] - Adaptability and versatility to various situations and volumes of liquids to be contained;

[0185] - Limited cost associated with the benefits achieved compared to traditional solutions.

[0186] The invention described may be modified and adjusted in several ways without departing from the scope of the inventive concept.

[0187] Furthermore, all details can be replaced by other technically equivalent elements.

[0188] Finally, the components used and their dimensions can vary depending on requirements and existing technology, provided they are compatible with a specific application.

[0189] Although reference numerals follow the features and techniques mentioned in the appended claims, these numerals are used solely for the purpose of enhancing the comprehensibility of the claims themselves. Therefore, the reference numerals do not in any way constitute a limitation on the interpretation of each element identified by the reference numerals as an example only.

Claims

1. A container (1) pre-filled or capable of being pre-filled with one or more substances, said container comprising: A compressible actuated compartment (2) for containing one or more substances; The dispensing compartment (3) includes: a first part (31) equipped with at least one dispensing member of the one or more substances; and a second part (32) wherein the second part (32) of the dispensing compartment (3) and the actuation compartment (2) are hydrodynamically connected; Actuator element (4) is arranged inside the container (1) and has a head (42) including a conical closure portion (424) and adapted to engage between the actuation compartment (2) and the dispensing compartment (3) of the container (1). The actuator element (4) is movable so as to move from a closed position to an open position. In the closed position, the actuator element hermetically and / or hydrodynamically isolates the contents of the actuation compartment (2) from the contents of the dispensing compartment (3). In the open position, the actuator element (4) hydrodynamically connects the actuation compartment (2) and the dispensing compartment (3) to allow the dispensing of one or more substances via the at least one dispensing member; The container (1) is characterized in that the head (42) of the actuator element (4) includes a first sliding crown (422) larger than the closed portion (424), the first sliding crown being provided with one or more mixing devices.

2. The container (1) according to claim 1, characterized in that, The actuator element (4) moves from the closed position to the open position when the actuation chamber (2) is squeezed.

3. The container (1) according to claim 1, characterized in that, The actuation chamber (2) is configured such that when the actuation chamber is compressed, it interferes with the actuator element (4) to allow movement of the actuator element.

4. The container (1) according to claim 1, characterized in that, The actuator element (4) includes a rod (41) connected below the closed portion (424).

5. The container (1) according to claim 4, characterized in that, When the actuator element (4) is in the closed position, the rod (41) is accommodated in the actuation compartment (2).

6. The container (1) according to claim 4, characterized in that, The rod (41) is elastic and / or flexible and has a generally rhomboid spring shape.

7. The container (1) according to claim 5, characterized in that, The actuation compartment (2) has a forming portion (22) adapted to receive the free end of the rod portion (41) of the actuator element (4) in order to guide the actuator element to translate along its axis.

8. The container (1) according to claim 4, characterized in that, The head (42) includes one or more receiving portions (421) arranged above the closed portion (424) opposite to the rod (41).

9. The container (1) according to claim 8, characterized in that, The head (42) includes one or more second sliding crowns (425) located between the receiving portion (421) and the first sliding crown (422).

10. The container (1) according to claim 1, characterized in that, The hybrid device is selected from at least one of the following: Through hole (4221); and / or Hook (4222), said hook being obtained on the outer periphery of the first sliding crown (422); and / or A lateral incision (4223) is made on the periphery of the first sliding crown (422); and / or Triangular pieces; and / or Cross-shaped component.

11. The container (1) according to claim 1, characterized in that, The head (42) includes a release section (423) disposed on top to improve the mixing of the one or more substances to be dispensed.

12. The container (1) according to claim 11, characterized in that, The release part (423) is made of a soft material to allow the release part to be inserted into the base of the insert located in the first part (31) or into the insertion nozzle (311, 312), and to avoid reuse of the container (1) when the actuator element (4) is in the open position.

13. The container (1) according to claim 1, characterized in that, The head (42) has a locking region (426) which can be made of different materials and have different shapes for blocking needles and / or other dispensing accessories connected to the container (1) for dispensing one or more substances to be dispensed, so as to prevent reuse.

14. The container (1) according to claim 1, characterized in that, The container includes a sealing insert (5) having a generally truncated conical shape and arranged within the container (1), and having One or more protrusions or peripheral recesses (52) along the sidewall (53) of the sealing insert for anchoring at the second part (32); as well as A converging section (51) is arranged between the actuation compartment (2) and the distribution compartment (3); The actuator element (4) is in a sealing engagement with the converging portion (51) when it is in the closed position; The sealing insert (5) and the actuator element (4) can be assembled and tested before being inserted into the container (1).

15. The container (1) according to claim 14, characterized in that, The sealing insert (5) includes a pair of operating rods (512) arranged within the actuation chamber (2), and The characteristic is that each of the operating levers (512) is fixed to the outer surface of the converging portion (51) or the outer surface of the sidewall (53), and Includes a hook-shaped release part (513) such that when the operating lever (512) is operated by squeezing the actuation chamber (2), the hook-shaped release part (513) interferes with the actuator element (4), and disengages the actuator element (4) from the convergence part (51) by moving the actuator element (4) from the closed position to the open position.

16. The container (1) according to claim 14, characterized in that, The sealing insert (5) includes a triggering device (54) connected to the sealing insert (5) via one or more tabs (513) and has a thrust member (512). When the actuation compartment (2) is squeezed, the triggering device (54) moves, causing the thrust member (512) to cause the closed portion (424) of the actuator element (4) to disengage from the converging portion (51).

17. The container (1) according to claim 1, characterized in that, The actuation compartment (2) has a spherical or elliptical shape.

18. The container (1) according to claim 1, characterized in that, The actuation compartment (2) includes one or more bellows (21, 211) to facilitate the compressibility of the actuation compartment.

19. The container (1) according to any one of the preceding claims, characterized in that, The at least one allocation component includes: Nozzle (311), said nozzle being disposed on the top or side wall of the dispensing compartment (3); or A pair of nozzles (311, 312) are arranged at a distance to allow the substance to be dispensed into the nostrils of the user's nose.

20. A method for dispensing at least one substance using a container (1) according to any one of the preceding claims, wherein, The substance is contained in the actuation compartment (2) and / or the dispensing compartment (3), and the method includes the following steps: Disengage the actuator element (4) to hydrodynamically connect the actuation compartment (2) and the dispensing compartment (3) until a predetermined threshold is reached; and The at least one substance is dispensed by the at least one dispensing member (311, 312, 314).

21. The method according to claim 20, characterized in that, The method includes the step of mixing the contents of the actuation compartment (2) with the contents of the dispensing compartment (3) after disengaging the actuator element (4).

22. The method according to claim 20 or 21, characterized in that, The method includes the step of mixing the contents of the actuation compartment (2) with the contents of the distribution compartment (3) after disengaging the actuator element (4) and before opening the one or more distribution members.

23. The method according to claim 22, characterized in that, The mixing is performed through the mixing device (4221, 4222) of the first sliding crown (422).

24. A method for producing a container (1) according to any one of claims 1-19, comprising the following steps: Increase the temperature of the container (1) to enable the container to function; Insert the actuator element (4) into the container (1); as well as The actuator element (4) is centered and engaged between the actuation compartment (2) and the distribution compartment (3).

25. The method according to claim 24, characterized in that, The method further includes the step of inserting the sealing insert (5) into the container (1), wherein the actuator element (4) is pre-assembled in the sealing insert (5) before the sealing insert (5) is centered and engaged in the container (1) and before the container (1) is closed.

26. The method according to claim 24 or 25, characterized in that, The actuation compartment (2) and / or the distribution compartment (3) are molded by a "blow-fill seal" process.

27. The method according to claim 26, characterized in that, The distribution compartment (3) and the actuation compartment (2) are formed and calibrated by inserting the actuator element (4) into the container (1).

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