Portable injection assembly for injecting solutions - Patent application
The portable injection assembly addresses solubility and stability issues by mixing and filtering solutions on demand, ensuring continuous and stable delivery of the final product, thereby overcoming storage-related degradation and toxicity concerns.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2024-03-15
- Publication Date
- 2026-03-11
AI Technical Summary
Existing portable injection devices face challenges with solubility and stability issues of injectable products, leading to potential degradation and toxicity, especially when storing solutions for extended periods.
A portable injection assembly that mixes two solutions on demand using interconnected syringes, a 'Y' connector, and a filtration device, ensuring immediate generation and continuous delivery of the final solution without pre-storage, while maintaining stability and solubility.
The assembly effectively injects solutions prone to rapid deterioration by mixing and filtering them just before use, reducing degradation risks and ensuring continuous, stable delivery to the patient.
Smart Images
Figure 2026508692000001_ABST
Abstract
Description
[Technical Field]
[0001] The present invention relates to the field of portable injection devices, and more particularly to the field of portable injection devices for injecting solutions that have injection constraints specific to the product being injected. [Background technology]
[0002] In the context of disease treatment, it is common to inject products substantially continuously and for periods that can last several hours. Such injections over a long period of time can, in particular, ensure that the injected product can be accepted and absorbed by the patient within the limits of its physiological capacity. In this way, infusion of a product over a long period of time can inject a minimal amount of product into the patient, for example, by reducing the concentration, while leaving the body sufficient time to absorb and metabolize the product. Therefore, in the context of a product that is likely to exhibit certain toxicity, this long-term injection can ensure that the injected product remains at a concentration level that the patient's body can tolerate.
[0003] In particular, in consideration of the lengthy duration of injection therapy, injection devices that enable outpatient therapy have been developed. For example, it is common practice to attach a pump, such as a wearable pump, to a patient, which is connected to a reservoir containing an injection, and to administer an intravenous drip infusion in which the outlet orifice of the reservoir is connected to the patient's body.
[0004] In certain therapeutic contexts, outpatient treatment is hindered, particularly when the injectable product has solubility and / or stability issues, since suspending the product in its solvent can compromise the homogeneity of the injected solution. Similarly, product degradation caused by this lack of stability, including the formation of precipitates or even toxic compounds, can prevent portable devices from storing product in their reservoirs for extended periods of time, such as hours, especially until all of the product has been properly injected into the patient. Summary of the Invention [Problem to be solved by the invention]
[0005] The aim of the present invention is to overcome these drawbacks by proposing a technical solution for injecting products into patients that are likely to exhibit solubility limitations and / or reduced stability, while dispensing them without the need for storage in dedicated on-board reservoirs, while retaining the advantages offered by existing portable devices. [Means for solving the problem]
[0006] The present invention relates to a portable injection assembly for a solution obtained by mixing two solutions of a specific composition, said injection assembly comprising: a first syringe having a reservoir adapted to store a first solution and an opening connected to the first tube; a second syringe having a reservoir adapted to store a second solution and an opening connected to the second tube; A mechanism for interlocking and moving the plungers of the two syringes; a "Y" connector having at one end two inlets connected to a first tube and a second tube, respectively, and at the other end an outlet connected to the first end of the inlet tube; a connection interface for connection to an administration device, the connection interface being arranged at a second end of an infusion tube, the infusion tube being connected to a filtration device arranged upstream of the connection interface in the flow direction of the infusion; The present invention is characterized by comprising:
[0007] The invention will be better understood from the following description of preferred embodiments given as non-limiting examples and illustrated with reference to the accompanying schematic drawings, in which: FIG. [Brief explanation of the drawings]
[0008] [Figure 1]1 is a schematic diagram illustrating an example of an injection assembly design according to the present invention.
[0009] [Figure 2] 1 is a schematic diagram illustrating an example of an actuation mechanism that can be used in the context of an injection assembly according to the present invention. DETAILED DESCRIPTION OF THE INVENTION
[0010] The present invention relates to a portable injection assembly 1 for a solution obtained by mixing two solutions of a specific composition, the injection assembly 1 comprising: a first syringe 2, the reservoir 21 of which is suitable for storing a first solution and the opening 22 of which is connected to a first tube 42; a second syringe 3, the reservoir 31 of which is suitable for storing a second solution and the opening 32 of which is connected to a second tube 43; a mechanism 5 for actuating and moving the plungers 23, 33 of the two syringes 2, 3 in conjunction with each other; a "Y" connector 6 having at one end two inlets 62, 63 connected to the first tube 42 and the second tube 43 respectively, and at the other end an outlet 61 connected to the first end of the inlet tube 41; a connection interface 7 for connection to an administration device, the connection interface 7 being arranged at a second end of an injection tube 41, the injection tube 41 being connected to a filtration device 8 arranged upstream of the connection interface 7 relative to the flow direction of the injection; The present invention is characterized by comprising:
[0011] In the context of implementing the injection assembly 1 of the present invention, the actuation mechanism 5 provides a joint, gradual, and controlled movement of the plungers 23, 33 of the syringes 2, 3, respectively. The movement of these plungers 23, 33 then extracts the first and second solutions stored in the respective reservoirs 21, 31 through the respective openings 22, 32 of the syringes 2, 3. These first and second solutions are then guided through the first and second tubes 42, 43, respectively, to the "Y" connector 6, where they are mixed. Thus, the final solution to be injected is generated at this "Y" connector 6 by mixing the solutions stored in the reservoirs 21, 31 of the syringes 2, 3 of the injection assembly 1. This final solution generated at the "Y" connector 6 then flows along the injection tube 41 to the connection interface 7 for connection to an administration device. Thus, a final solution corresponding to the final product emerges from the injection assembly 1 at this connection interface 7.
[0012] It should be noted that this administration device may be realized by an injection device for injecting the composition into the patient, or alternatively by an intermediate device for processing the composition before it travels to the patient.
[0013] According to one embodiment of a design variant of the injection assembly 1 of the invention, the injection assembly 1 also comprises an administration device realized by an injection device connected to a connection interface 7 at the second end of the injection tube 41. This injection device comprises a connection interface for cooperating with the connection interface 7 at the end of the injection tube 41. This injection device may correspond to a parenteral injection device, such as a subcutaneous and / or intravenous and / or intramuscular injection device, or an enteral injection device.
[0014] It should be noted that insofar as the injection assembly 1 of the present invention is intended to be essentially portable, the various tubes 41, 42, 43 are essentially made from materials that allow flexibility and / or elasticity to allow the patient to adjust their position, while still exhibiting sufficient rigidity to limit the risk of one or the other flow of the solution being blocked in the process by accidental pinching.
[0015] Considering the pressure exerted by each of the plungers 23, 33 of each of the syringes 2, 3 of the assembly, the various solutions within the injection assembly 1 will flow to the connection interface 7 at the end of the injection tube 41 essentially due to the pressure difference between the ends of the various tubes 41, 42, 43. Secondly, the evacuation of the final solution out of the connection interface 7 and associated administration device can also contribute to the flow of the solution along the various tubes 41, 42, 43, especially as the final solution is being absorbed by the tissue.
[0016] It should be noted that the first and second solutions stored in the respective syringes 2, 3 have compositions that differ from each other and from the composition of the solution that results when they are mixed at the "Y" connector 6. In the context of this mixing, the final solution produced can correspond to a simple mixture of the respective compositions of each solution from the syringes 2, 3 of the injection assembly 1. Alternatively, this final solution can correspond to the reaction product of the reactants present in each solution from the syringes 2, 3, respectively.
[0017] The injection assembly 1 of the present invention allows the injection of solutions that are at risk of rapid deterioration, while eliminating the need for storage of the solution to be injected. The injection assembly 1 avoids all problems associated with storing the solution to be injected by generating this solution immediately before it leaves the injection assembly 1 of the present invention and is injected. The injection assembly 1 according to the present invention therefore makes it possible to produce the final product to be injected during the injection process only by activating the mechanism 5 that activates and moves the plungers 23, 33 of the syringes 2, 3 of the injection assembly 1, respectively.
[0018] It should be noted that only the initial solution contributing to the formation of this final solution is stored in the dedicated reservoirs 21, 31 of the injection assembly 1. Therefore, if the final solution to be injected contains at least one component that exhibits limited stability over time, it will not be stored by the injection assembly 1 of the present invention. Therefore, the formation of the final solution to be injected during the injection process via the injection assembly 1 can be guaranteed in this way, ensuring that the final solution created is not stored for as short a time as possible during its stability period. This stability period is therefore essentially dedicated to delivering the final solution to the connection interface 7 of the injection tube 41 and the connected administration device, where it can be absorbed by the tissues of the patient being treated. Similarly, if the final solution to be injected contains one or more components with reduced solubility, the limited time during which these components are solubilized and have not yet precipitated is utilized to deliver the final solution to the connection interface 7 and the administration device, where it can be absorbed by the tissues of the patient being treated.
[0019] To avoid toxicity issues of the final solution to be injected, which may be related to a lack of purity of the composition, for example, that the final solution produced begins to deteriorate or that toxic compounds are formed during this deterioration, the filtration device 8 is arranged upstream of the connection interface 7 in the flow direction of the injection. Preferably, the filtration device 8 is arranged as close as possible to the outlet orifice of the injection assembly 1, i.e., as close as possible to the connection interface 7. Such an arrangement therefore optimizes the filtration of the solution to be injected. In particular, this arrangement makes it possible to significantly reduce or eliminate both the risk of deterioration of the components of the solution to be injected and the risk of toxic compounds being formed between the step of filtering this solution and the step of injecting it by the administration device. According to one design example, the filtration device 8 is arranged as an intermediate section between the end of the injection tube 41 and the administration device, such that the connection interface 7 is located at the outlet of the filtration device 8 at the end of the injection tube 41. According to another example, the filtration device 8 is integrated into the injection tube 41, for example, inside the tube 41, upstream of the connection interface 7, e.g., at the end of the injection tube 41.
[0020] It should also be noted that in the context of the injection assembly 1, the final solution to be injected is thus obtained through a gentle, controlled mixing of the solutions stored in each of the reservoirs 21, 31 of the syringes 2, 3 of the injection assembly 1. The various initial solutions are only mixed at the intersection of the tubing of the "Y" connector 6. Furthermore, the realization of a gradual and substantially continuous movement of the plungers 23, 33 of the syringes 2, 3, respectively, by the actuation and movement mechanism 5 makes it possible to obtain a continuous generation of the final solution to be injected and its continuous flow along the injection tubing 41.
[0021] According to one example of a design variant of the injection assembly 1 of the present invention, which can be combined with one or more of the variants detailed above, the injection assembly 1 also includes a unidirectional flow device 9 located downstream of the "Y" connector 6. While the pressure difference between the ends of the various tubes 41, 42, and 43 can naturally cause the flow of solutions to be unidirectional, the incorporation of the unidirectional flow device 9 makes it possible to prevent the risk of contamination of the first and second solutions flowing along the first tube 42 and / or the second tube 43, respectively, especially in the event of accidental backflow of the final solution. This reduces the risk that the final solution produced at the intersection of the "Y" connector 6 will flow back along one or the other of the first tube 42 and / or the second tube 43. When normal flow resumes, such backflow may impair the proportions of the mixture produced in the "Y" connector 6, which would likely result in a change in the composition of the final solution produced. Preferably, this unidirectional flow device 9 is located as close as possible to the "Y" connector 6 to prevent accidental backflow that may occur along the entire length of the injection tube 41.
[0022] According to one embodiment of a design variant of the injection assembly 1 of the present invention, which can be combined with one or more of the variants detailed above, the reservoir 21 of at least one syringe 2 and / or the connected tubing 42 are resistant to a pH of less than 4, preferably less than 3, and ideally less than 2. Storing certain solutions is likely to require specific acidic conditions to ensure the solubility of the components and / or the stability of their composition, or to avoid, if not limit, the degradation of one or other of the components of these solutions. Furthermore, the components of the injection assembly 1 that contribute to the storage and / or flow of these solutions must be adapted to the acidity requirements of these solutions, in order to reduce the risk that the operation of the injection assembly will be impaired by the degradation of one or other of the components that come into contact with the acidity of the solutions in the reservoir 21 of the syringe 2 or that flow in the tubing 42 or in the "Y" connector 6.
[0023] According to one embodiment of a design variant of the injection assembly 1 of the present invention, which can be combined with one or another of the variants detailed above, the reservoir 31 of at least one syringe 3 and / or the connected tubing 43 are resistant to a pH above 10, preferably above 11, and ideally above 12. Storing certain solutions is likely to require specific alkaline conditions to ensure the solubility of the components and / or the stability of their composition, or to avoid, if not limit, the degradation of one or another of the components of these solutions. Furthermore, the components of the injection assembly 1 that contribute to the storage and / or flow of these solutions must be suited to the alkalinity requirements of these solutions, in order to reduce the risk that the operation of the injection assembly will be impaired due to the degradation of one or another of the components that are in contact with the alkalinity of the solutions in the reservoir 21 of the syringe 2 or that flow in the tubing 42 or in the "Y" connector 6.
[0024] It should be noted that the final solution, when injected into a patient by the injection assembly 1 via an administration device, should have a physiologically acceptable pH for the tissues that will absorb it. Therefore, the pH of the final solution is preferably about 5 or 6 and / or within this range of 5-6. If the stability and / or solubility of one or more of the components of the final solution may be such that they can only be preserved in a solution whose pH is significantly outside the physiologically acceptable range, it is essential to weaken the acidity or alkalinity of the stored solution to reach a physiologically acceptable pH before the components are injected. In the context of the injection assembly 1 of the present invention, the storage solution filling the first reservoir 21 of the injection assembly 1 is also mixed in the "Y" connector 6 with a buffer solution stored in the second reservoir 31 of the injection assembly 1 to compensate for the acidity or alkalinity of the storage solution. As a result, the final solution generated in the infusion tube 41 at the outlet of the "Y" connector 6 and flowing to the connection interface 7 connected to the administration device has a physiologically acceptable pH.
[0025] According to one example of a design variant of the injection assembly 1 of the present invention, which can be combined with one or more of the variants detailed above, the reservoir 21, 31 of at least one syringe 2, 3 comprises a wall made of a material having a composition including at least one resin of the polyolefin plastic and / or polyethylene type. According to a preferred design example, the material of at least one reservoir 21, 31 of the syringes 2, 3 of the injection assembly 1 of the present invention includes a cyclic olefin copolymer known under the trademark TOPAS®, for example. Therefore, resins under the name COC TOPAS are materials that can be used to construct one or more reservoirs 21, 31 of the syringes 2, 3 of the injection assembly 1. This is because COC TOPAS resin is resistant to both acidic solutions such as hydrochloric acid, sulfuric acid, nitric acid, and acetic acid, as well as alkaline solutions such as sodium hydroxide and aqueous ammonia. Additionally, COC TOPAS resin has the advantage of being sufficiently amorphous, which allows it to actively comply with regulatory constraints requiring direct contact with the drug solution.
[0026] According to one example of a design variant of the injection assembly 1 of the present invention, which can be combined with one or another of the variants detailed above, the reservoir 21, 31 of at least one syringe 2, 3 comprises a plunger head 23, 33 made of a material having a composition that includes at least bromobutyl, such as bromobutyl rubber. This type of material is able to form an elastic seal that is gas-, air- and moisture-tight, thereby allowing the environment inside the reservoir 21, 31 to be particularly controlled when the solution present in the reservoir 21, 31 is likely to be sensitive to compounds in the external environment, such as oxygen. Furthermore, this type of material is substantially free of organic substances that can penetrate or react with the solution present in the reservoir 21, 31.
[0027] According to one embodiment of a design variant of the injection assembly 1 of the present invention, which can be combined with one or more of the variants detailed above, the reservoir 21, 31 and / or the "Y" connector 6 and / or at least one tube 41, 42, 43 of at least one syringe 2, 3 are made of a material that is opaque to ultraviolet light. To ensure the solubility of the components of the stored or flowing solutions and / or the stability of their composition, or to avoid, but not limited to, degradation of one or other of these solution components, it may be necessary to limit, if not prevent, the interaction of these solutions with optical radiation of certain wavelengths. It is also essential that the components of the injection assembly 1 that contribute to the storage and / or flow of these solutions meet opacity requirements to avoid accidental degradation of the mixture of solutions generated in the "Y" connector 6 and the final solution injected by the administration device located at the end of the injection tube 41. It should be noted that opacity can be achieved in one or other of the reservoirs 21, 31 of the syringes 2, 3 without changing the material of the reservoirs 21, 31. This is because simply placing the reservoirs 21, 31 in an opaque storage portion or covering the outer surfaces of the reservoirs 21, 31 with an opaque material is sufficient to prevent undesirable effects that occur after light is irradiated onto the solution stored in the reservoirs 21, 31.
[0028] According to one example of a design variation of the injection assembly 1 of the present invention, which can be combined with one or more of the variations detailed above, the length of the injection tube 41 is longer than the respective lengths of the first tube 42 and the second tube 43 of the injection assembly 1. According to this design variation, the first tube 42 and the second tube 43 are arranged so that the "Y" connector 6 is as close as possible to the openings 22 and 32 of the syringes 2 and 3. As a result, the tubing length between the syringes 2 and 3 and the connection interface 7 is essentially realized by the injection tube 41. This configuration makes it possible to obtain an injection assembly that limits the tubing volume or avoids excessive tubing length, thereby reducing the risk of blocking the flow of any solution due to accidental pinching of the tubing. Furthermore, this design variation makes it possible to allocate a maximum flow length to the final solution to be injected, so that the mixture generated at the "Y" connector 6 during its flow through the injection tube 41 can achieve optimal homogeneity when it reaches the connection interface 7 and the administration device at the end of the injection tube 41.
[0029] According to one example of a design variant of the injection assembly 1 of the present invention, which can be combined with one or other of the variants detailed above, the actuation and movement mechanism 5 comprises at least one rotary motor 51 connected to a threaded shaft 52 which engages with a nut 53 to axially move the plunger 23, 33 of at least one syringe 2, 3. According to this design variant, the plunger 23, 33 of the driven syringe 2, 3 is structurally connected to the nut 53 of the actuation mechanism 5 and moves axially together with the nut 53 due to the axial rotational action of the threaded shaft 52 driven by the motor 51.
[0030] According to a particular variant related to the example detailed above, the plungers 23, 33 of the syringes 2, 3 are structurally coupled to the nut 53 of the actuation mechanism 5 and are driven by the motor 51 to move in unison at the same speed. In the context of such a design variant, the cross-sections of the syringes 2, 3, and in particular their respective reservoirs 21, 31, should be configured to inject the respective initial solutions into the first tube 42 and the second tube 43 in proportions suitable to produce the final solution to be injected by mixing in the "Y" connector 6.
[0031] According to one example of a design variant of the injection assembly 1 of the invention, which can be combined with one or another of the variants detailed above, the actuation and movement mechanism 5 comprises: a rotary motor that is coupled to the axial movement of the plungers 23, 33 of the syringes 2, 3 via a screw shaft that is coupled to a nut; an interface connected to each rotation motor of the mechanism 5 for controlling and adjusting the axial movement of the plunger 23, 33 of each syringe 2, 3; In the context of such a design variation, actuation of each syringe 2, 3 is independent, as actuation mechanism 5 assigns a dedicated motor to each syringe 2, 3. Actuation of each of syringes 2, 3 can also be adjusted by the control interface based on the cross-sectional area of the respective reservoirs 21, 31 of syringes 2, 3. This actuation can also be adjusted so that the respective initial solutions are injected into first tube 42 and second tube 43 based on the desired properties of these initial solutions in the mixing that takes place in "Y" connector 6 to produce the final solution to be injected.
[0032] According to one example of a design variant of the injection assembly 1 of the present invention, which can be combined with one or more of the variants detailed above, the actuation and movement mechanism 5 is configured to effect continuous injection of the final solution through the connection interface 7, in particular the administration device, at the end of the injection tube 41. According to a first alternative way of doing this, the actuation mechanism 5 imparts a constant and continuous movement to the plungers 23, 33 of each syringe 2, 3, thereby resulting in a constant and continuous flow of the respective initial and final solutions along the injection tube 41. However, such a solution requires the drive of the actuation mechanism 5 to be constantly activated throughout the entire duration of the injection, which, in the context of a portable assembly, requires the provision of an energy storage device for this actuation. According to a second alternative way of doing this, the actuation mechanism 5 imparts a periodic movement to the plungers 23, 33 of each syringe 2, 3, which is repeated at regular intervals. The periodic movement of the plungers 23, 33 injects the solution from the associated reservoirs 21, 31 of the syringes 2, 3 into the dedicated tubes 42, 43. However, taking into account the viscosity of the solutions flowing through the various tubes 41, 42, 43 of the injection assembly 1, the intermittent movements of the plungers 23, 33 result in a local overpressure of the solution from the openings of the syringes 2, 3, supported by the elasticity of the tubes 42, 43. This local overpressure in a portion of the tubes 42, 43 is intermittent and gradually decreases between two intermittent movements of the plungers 23, 33 as the initial and final solutions flow along the tubes 41, 42, 43. This flow takes the form of a continuous flow at the end of the injection tube 41 and at the connection interface 7. As a result, despite the intermittent and repeated movements and actuations of the plungers 23, 33 to gradually and discontinuously empty one or more reservoirs 21, 31 of the syringes 2, 3, the flow at the end of the injection tube 41 or the connection interface 7 can be continuous, depending on the amplitude of the intermittent movements of the plungers 23, 33 and the time interval between two successive movements of the plungers 23, 33. As an example of how this can be done, in the injection assembly 1 according to the present invention, intermittent movements of the plungers 23, 33 can be performed to inject 10 μI into the first tube 42 and the second tube 43 at intervals of 18 seconds to obtain a flow rate of approximately 2 ml per hour into the injection tube 41.
[0033] According to one example of a design variant of the injection assembly 1 of the present invention, which can be combined with one or more of the variants described in detail above, the actuating and moving mechanism 5 is connected to a device for detecting an occlusion along one of the tubes 41, 42, 43 of the injection assembly 1.
[0034] According to one example of a design variation of the occlusion detection device, the device comprises a pressure sensor arranged along at least one axis of movement of the plunger 23, 33 of the syringe 2, 3. As a result, when various solutions, such as the initial and final solutions, flow normally through the tubes 41, 42, 43 of the injection assembly 1, the pressure experienced by the sensor remains substantially constant as the plunger 23, 33 advances along its movement. The sensor pressure may intermittently and briefly peak and then return to a constant pressure value, particularly at and immediately after the intermittent movements of the plunger 23, 33. If the flow along one or other of the tubes 41, 42, 43 of the injection assembly 1 is blocked or obstructed, the advancement of the plunger 23, 33 slows or stops, while the pressure at the pressure sensor gradually increases, possibly even to a maximum value. Furthermore, the detection device issues a warning signal as soon as the threshold value acquired by the pressure sensor is exceeded.
[0035] According to one embodiment of a design variation of the occlusion detection device, the occlusion detection device includes at least one sensor for measuring the actual movement of at least one plunger 23, 33 and an algorithm for comparing this actual movement with a predetermined theoretical movement. The measurement sensor is also connected to an interface for identifying the magnitude of the actual movement of the plunger 23, 33 and comparing this actual magnitude with the expected actual magnitude of this same plunger 23, 33. Thus, when the various solutions, initial solution, and final solution are flowing normally through the tubing 41, 42, 43 of the injection assembly 1, the actual magnitude of the plunger 23, 33 is similar or identical to the expected actual magnitude of this same plunger 23, 33. However, even if the actual magnitude deviates from the expected actual magnitude and the flow is not blocked or impeded, the difference in magnitude is designed to remain substantially constant as the plunger 23, 33 advances along its path of movement. Monitoring this deviation in the magnitude of the movement of the plunger 23, 33 as it advances can be associated with a dedicated algorithm. However, if flow along one or another of the tubes 41, 42, 43 of the injection assembly 1 is blocked or impeded, the advancement of the plunger 23, 33 slows or stops, causing the actual magnitude of the plunger 23, 33 to deviate from the expected magnitude of the actual movement of that same plunger 23, 33, and the detection device generates a warning signal. In one implementation, the expected magnitude of the actual movement can be evaluated or calculated by a specific algorithm associated with the detection device, or can be predetermined and recorded in a database associated with the detection device. Additionally, in one implementation of this detection mechanism, the magnitude of the plunger 23, 33 movement can be determined by evaluating the pitch of the nut 53 moving along the threaded shaft 52.
[0036] According to one example of a design variant of the injection assembly 1 of the present invention, which can be combined with one or more of the variants detailed above, the injection assembly 1 also comprises a device for reversible connection between the "Y" connector 6 and the first end of the injection tube 41. This reversible connection device has the advantage that the injection tube 41 can be replaced quickly and more easily. Thus, if a problem with the flow of the final solution to be injected is identified at the end of the injection tube 41 at the connection interface 7 or in the administration device, or if an obstruction of the flow along the injection tube 41 is detected, the injection assembly 1 of the present invention can be easily treated by removing the obstructed injection tube 41 and replacing it with a new tube. This new tube end is connected to a new administration device, such as an infusion device to be attached to the patient to be treated, or via a corresponding connection interface on an administration device, such as an infusion device, already attached to the patient to be treated.
[0037] According to one example of a design variation of the injection assembly 1 of the present invention, which can be combined with one or another of the variations detailed above, the filtering device 8 is of the ceramic, or cellulose acetate, or acrylic copolymer, or polytetrafluoroethylene polymer, or polyethersulfone cartridge type, allowing a filtration of about 0.2 microns. As an example of how this design variation can be implemented, the filtering device 8 is about 5 cm 2 The filter has a filtration surface area of 1000 nm, allowing for filtration of 0.22 microns. By selecting polytetrafluoroethylene polymer, it is possible to obtain a filter device 8 in the form of a chemically stable and inert microporous film, which can filter any potentially corrosive product. By selecting polyethersulfone, it is possible to obtain a filter device 8 that captures particulates, bacteria, and fungi during aqueous solution filtration, while having a low adsorption rate for proteins in the filtrate.
[0038] Naturally, the invention is not limited to the embodiments described and shown in the attached drawings: modifications are still possible, in particular with regard to the combination of the various components or by substitution of equivalent techniques, without departing from the scope of protection of the invention.
Claims
1. A portable injection assembly (1) for a solution obtained by mixing two solutions of a specific composition, said injection assembly (1) comprising: a first syringe (2) with a reservoir (21) suitable for storing a first solution and an opening (22) connected to a first tube (42); a second syringe (3) whose reservoir (31) is suitable for storing a second solution and whose opening (32) is connected to a second tube (43); a mechanism (5) for actuating and moving the plungers (23, 33) of the two syringes (2, 3) in unison; a "Y" connector (6) comprising, at one end, two inlets (62, 63) connected to the first tube (42) and the second tube (43), respectively, and, at the other end, an outlet (61) connected to the first end of the inlet tube (41); a connection interface (7) for connection to an administration device, the connection interface (7) being arranged at the second end of the injection tube (41), the injection tube (41) being connected to a filtration device (8) arranged upstream of the connection interface (7) relative to the flow direction of the injection; An injection assembly (1), characterized in that it comprises:
2. 2. An injection assembly (1) according to claim 1, characterized in that the injection assembly (1) also comprises a dosing device realized by an injection device connected to the connection interface (7) at the second end of the injection tube (41).
3. An injection assembly (1) according to claim 1 or 2, characterized in that the injection assembly (1) also comprises a unidirectional flow device (9) arranged downstream of the "Y" connector (6).
4. An injection assembly (1) according to any one of claims 1 to 3, characterized in that the reservoir (21) of at least one syringe (2) and / or the connected tubing (42) exhibits resistance to a pH of less than 4.
5. An injection assembly (1) according to any one of claims 1 to 4, characterized in that the reservoir (31) of at least one syringe (3) and / or the connected tubing (43) exhibits resistance to a pH of more than 10.
6. An injection assembly (1) according to any one of claims 1 to 5, characterized in that the reservoir (21, 31) of at least one syringe (2, 3) comprises a wall made of a material having a composition comprising at least one resin of polyolefin plastic and / or polyethylene type.
7. An injection assembly (1) according to any one of claims 1 to 6, characterized in that the reservoir (21, 31) of at least one syringe (2, 3) comprises a plunger head (23, 33) made of a material having a composition comprising at least bromobutyl.
8. An injection assembly (1) according to any one of claims 1 to 7, characterized in that the reservoir (21, 31) and / or the "Y" connector (6) and / or at least one tube (41, 42, 43) of at least one syringe (2, 3) are made of a material that is opaque to ultraviolet light.
9. An injection assembly (1) according to any one of claims 1 to 8, characterized in that the injection tube (41) is longer than each of the first tube (42) and the second tube (43) of the injection assembly (1).
10. An injection assembly (1) according to any one of claims 1 to 9, characterized in that the actuation and movement mechanism (5) comprises at least one rotary motor (51) connected to a threaded shaft (52) interacting with a nut (53) and adapted to axially move the plunger (23, 33) of at least one syringe (2, 3).
11. The actuation and movement mechanism (5) a rotary motor coupled to the axial movement of the plunger (23, 33) of each syringe (2, 3), an interface for controlling and regulating the axial movement of the plunger (23, 33) of each syringe (2, 3), the interface being connected to each of the rotary motors of the mechanism (5); An injection assembly (1) according to any one of claims 1 to 10, characterized in that it comprises:
12. An injection assembly (1) according to any one of claims 1 to 11, characterized in that the actuation and movement mechanism (5) is connected to a device for detecting occlusions along any one of the tubes (41, 42, 43) of the injection assembly (1).
13. An injection assembly (1) according to claim 12, characterized in that the occlusion detection device comprises a pressure sensor arranged along at least one axis of movement of the plunger (23, 33) of the syringe (2, 3).
14. 13. An injection assembly (1) according to claim 12, characterized in that the occlusion detection device comprises at least one sensor for measuring the actual movement of at least one plunger (23, 33), and an algorithm for comparing this actual movement with a predetermined theoretical movement.
15. An injection assembly (1) according to any one of claims 1 to 14, characterized in that the injection assembly (1) also comprises a device for reversible connection between the "Y" connector (6) and the first end of the injection tube (41).
16. An injection assembly (1) according to any one of claims 1 to 15, characterized in that the filtering device (8) is of the cartridge type made of ceramic or cellulose acetate or acrylic copolymer or polytetrafluoroethylene or polyethersulfone, allowing filtration of about 0.2 microns.