Ambulatory injection assembly for injecting a solution

Abstract

The invention relates to an ambulatory injection assembly (1) for injecting a solution obtained by mixing two solutions with specific compositions characterised in that the assembly comprises: - a first syringe (2) with a reservoir (21) suitable for a first solution and associated with a first tube (42); - a second syringe (3) with a reservoir (31) suitable for a second solution and associated with a second tube (43); - a mechanism (5) for actuating the respective plungers (23, 33) of the syringes (2, 3); - a Y-connector (6) connected to the first (42) and second (43) tubes and to a first end of an injection tube (41); - a delivery device, such as an infusion device, connected by an interface (7) at the end of the injection tube (41), the injection tube (41) being associated with a filtration device (8) positioned upstream of the delivery device with respect to the injection flow direction.

Description

Description Title of the invention: Ambulatory solution injection system

[0001] The present invention relates to the field of ambulatory injection devices and more particularly to the field of ambulatory devices for injecting solutions which have injection constraints specific to the product to be injected.

[0002] In the treatment of diseases, it is common for injections of products to be carried out substantially continuously and for periods of up to several hours. Such long-term injections make it possible, in particular, to ensure that the injected products can be received and absorbed by the patient within the limits of their physiological capacities. The infusion of products over a long period thus allows, for example with a reduced concentration level, an injection to the patient of a minimal quantity of products, while allowing the body time to absorb and metabolize the product. Thus, in the case of products likely to present a certain toxicity, this long-term injection makes it possible to ensure that the injected product remains at concentration levels tolerated by the patient's body.

[0003] Given the duration of these injection treatments, which are likely to be particularly long, injection devices allowing outpatient treatment have been developed. Thus, it is common for a patient to be equipped with a pump, for example a portable one, associated with a reservoir containing the injection product, an infusion connecting the outlet port of the reservoir to the patient's body.

[0004] In the context of specific treatments, particularly when the injection product has a solubility and / or stability problem, outpatient treatment is compromised. Indeed, the problem of suspending the product in its solvent does not guarantee the preservation of homogeneity of the solution to be injected. Similarly, the degradation of the product due to this lack of stability, for example with the formation of a precipitate, or even the appearance of a toxic compound in the context of this degradation, does not allow the outpatient device to keep the product in its reservoir for a long period of several hours, and in particular until the entire quantity of product in the reservoir is correctly injected into the patient.

[0005] The present invention aims to overcome these drawbacks by proposing a technical solution making it possible to inject a patient with a product likely to present solubility constraints and / or reduced stability while avoiding its storage in a dedicated on-board reservoir, but retaining the advantages provided by existing ambulatory devices.

[0006] The invention relates to an ambulatory injection assembly for a solution obtained by mixing two solutions with specific compositions, characterized in that the injection assembly comprises: - a first syringe whose reservoir is adapted for storing a first solution and whose opening is associated with a first tube, - a second syringe whose reservoir is adapted for storing a second solution and whose opening is associated with a second tube, - a mechanism for actuating and jointly moving the respective pistons of each of the two syringes, - a “Y” connector comprising, on the one hand, two inputs respectively connected to the first pipe and to the second pipe and, on the other hand, an output connected to a first end of an injection pipe, - a connection interface to an administration device, this connection interface being positioned at a second end of the injection tubing, the injection tubing being associated with a filtration device positioned upstream of the connection interface relative to the direction of the injection flow.

[0007] The invention will be better understood from the following description, which relates to the preferred embodiments, given as non-limiting examples, and explained with reference to the appended schematic drawings, in which:

[0008] [Fig. 1] represents a schematic illustration of an example of construction of an injection assembly according to the invention,

[0009] Fig. 2] represents a schematic illustration of an example of an actuating mechanism capable of being used within the framework of an injection assembly according to the invention.

[0010] The present invention relates to an ambulatory injection set 1 for a solution obtained by mixing two solutions with specific compositions, characterized in that the injection set 1 comprises: - a first syringe 2 whose reservoir 21 is adapted for storing a first solution and whose opening 22 is associated with a first tube 42, - a second syringe 3 whose reservoir 31 is adapted for storing a second solution and whose opening 32 is associated with a second tube 43, - a mechanism 5 for actuating and jointly moving the respective pistons 23, 33 of each of the two syringes 2, 3, - a “Y” connector 6 comprising, on the one hand, two inlets 62, 63 respectively connected to the first tube 42 and to the second tube 43 and, on the other hand, an outlet 61 connected to a first end of an injection tube 41, - a connection interface 7 to an administration device, this connection interface 7 being positioned at a second end of the injection tubing 41, the injection tubing 41 being associated with a filtration device 8 positioned upstream of the connection interface 7 relative to the direction of the injection flow.

[0011] In the context of the implementation of the injection assembly 1 of the invention, the actuating mechanism 5 operates a joint, progressive and controlled movement of the respective pistons 23, 33 of each of the syringes 2, 3. The movement of these pistons 23, 33 then causes the extraction of the first and second solutions stored in the respective reservoirs 21, 31 through the openings 22, 32 of each of the syringes 2, 3. These first and second solutions are then respectively conducted by the first tube 42 and the second tube 43 to the “Y” connector 6 at which these solutions are mixed. The mixing of these solutions stored by the reservoirs 21, 31 of the syringes 2, 3 of the injection assembly 1 thus produces, at this “Y” connector 6, the final solution intended to be injected.This final solution produced at the “Y” connector 6 then flows along the injection tubing 41 to the connection interface 7 to an administration device. final solution which corresponds to the final product thus leaves the injection assembly 1 at the level of this connection interface 7.

[0012] It should be noted that this administration device is likely to be produced by an infusion device for injecting a composition into a patient or, alternatively, an intermediate device for processing the composition before its transfer to a patient.

[0013] According to an example relating to a construction variant of the injection assembly 1 of the invention, the injection assembly 1 also comprises an administration device produced by an infusion device associated with the connection interface 7 at the second end of the injection tubing 41. This infusion device comprises a connection interface for cooperating with the connection interface 7 at the end of the injection tubing 41. This infusion device is likely to correspond to a parenteral infusion device such as subcutaneous and / or intravenous and / or intramuscular or to an enteral infusion device.

[0014] To the extent that the injection assembly 1 of the invention is essentially intended to be ambulatory, it should be noted that the various tubes 41, 42, 43 are essentially made from materials allowing flexibility and / or elasticity to allow adjustment of their position by the patient, while having sufficient rigidity to limit the risks of blocking the flow of one or other of the solutions in the event of accidental pinching.

[0015] Given the pressure exerted by each of the pistons 23, 33 at each of the syringes 2, 3 of the assembly, the flow of the different solutions in the injection assembly 1 to the connection interface 7 at the end of the injection tubing 41 is essentially by pressure difference between the ends of the different tubings 41, 42, 43. Secondarily, the evacuation of the final solution which leaves at the connection interface 7 and the associated administration device, in particular in the context of the absorption of the final solution by the tissues, is also likely to participate in the flow of the solutions along the different tubings 41, 42, 43.

[0016] It should be noted that the first and second solutions stored at the level of respective syringes 2, 3 have compositions which, on the one hand, differ from each other and, on the other hand, differ from that of the solution which results from their mixing at the level of the “Y” connector 6. In the context of this mixing, the final solution produced is likely to correspond to a simple mixture of the respective compositions of each of the solutions coming from the syringes 2, 3 of the injection assembly 1. Alternatively, this final solution corresponds to a product resulting from the reaction of reagents respectively present in the respective solutions coming from the syringes 2, 3.

[0017] The injection assembly 1 of the invention makes it possible to inject a solution presenting a risk of rapid degradation by eliminating the need to store the solution to be injected. The injection assembly 1 avoids any problems related to the storage of the solution to be injected by producing this solution in the moments preceding its exit from the assembly 1 of the invention and therefore its injection. The injection assembly 1 according to the invention thus makes it possible to produce the final product to be injected during the injection process by simply activating the mechanism 5 for actuating and moving the pistons 23, 33 of each of the syringes 2, 3 of the injection assembly 1.

[0018] It should be noted that only the initial solutions which participate in the production of this final solution are stored in dedicated reservoirs 21, 31 of the injection assembly 1. Thus, when the final solution to be injected comprises at least one component which has limited stability over time, it is not subject to any storage by the injection assembly 1 of the invention. The production of the final solution to be injected within the framework of the injection by the injection assembly 1 thus makes it possible to ensure that, during its period of stability, however short it may be, this final solution produced does not require any storage. This period of stability is thus essentially dedicated solely to the delivery of the final solution to the connection interface 7 of the injection tubing 41 and to the associated administration device as well as to its absorption by the tissues of the patient being treated.Similarly, when the final solution to be injected includes one or more components with reduced solubility, the limited period during which these components are solubilized and not yet precipitated is used to be conveyed to. the connection interface 7 and to the administration device and absorbed by the tissues of the patient being treated.

[0019] In order to avoid any lack of purity in the composition of the final solution injected as well as any problem of toxicity of this composition which, for example, would be linked to the start of degradation of the final solution produced, or even to the appearance of a toxic compound in the context of this degradation, a filtration device 8 is positioned upstream of the connection interface 7 relative to the direction of the injection flow. Preferably, this filtration device 8 is positioned as close as possible to the outlet orifice of the injection assembly 1, that is to say as close as possible to the connection interface 7. Such positioning thus makes it possible to optimize the filtration of the injected solution.Indeed, this arrangement makes it possible to considerably reduce, or even eliminate, on the one hand, the risk of degradation of a component of the injected solution and, on the other hand, the risk of the appearance of a toxic compound between the step of filtration of this solution and its injection at the level of the administration device. According to an example of construction, the filtration device 8 is positioned as an intermediary between the end of the injection tubing 41 and the administration device so that the connection interface 7 is positioned at the outlet of the filtration device 8 at the end of the injection tubing 41. According to another example, the filtration device 8 is integrated into the injection tubing 41, for example inside the tubing 41, upstream of the connection interface 7, such as at the end of the injection tubing 41.

[0020] It should also be noted that, in the context of the injection assembly 1, the final solution to be injected is thus the result of a progressive and controlled mixing of the solutions respectively stored in each of the reservoirs 21, 31 of the syringes 2, 3 of the injection assembly 1. The mixing of the different initial solutions only takes place at the level of the intersection of the tubes of the “Y” connector 6. Furthermore, the production of a progressive and substantially continuous movement of the respective pistons 23, 33 of the syringes 2, 3 by the actuation and movement mechanism 5 makes it possible to obtain a production of the final solution to be injected and its flow along the injection tube 41 which are continuous.

[0021] According to an example relating to a construction variant of the injection assembly 1 of the invention capable of being combined with one or other of the previously detailed variants, the injection assembly 1 also comprises a unidirectional flow device 9 positioned downstream of the “Y” connector 6. Although, thanks to the pressure difference between the ends of the different tubes 41, 42, 43, the flow of the solutions is led to be naturally unidirectional, the integration of a unidirectional flow device 9 makes it possible to prevent any risk of contamination of the first and second solutions respectively flowing along the first 42 and / or second 43 tubes, in particular in the event of accidental occurrence of a reflux phenomenon of the final solution.Thus, the risk that the final solution produced at the intersection of the “Y” connector 6 rises along one or other of the first 42 and / or second 43 pipes is eliminated. When normal flow resumes, such a reflux would be likely to alter the proportions of the mixture produced at the “Y” connector 6 and therefore to modify the composition of the final solution produced. Preferably, this unidirectional flow device 9 is positioned as close as possible to the “Y” connector 6, so as to allow the blocking of any accidental reflux likely to appear over the entire length of the injection pipe 41.

[0022] According to an example relating to a construction variant of the injection assembly 1 of the invention capable of being combined with one or other of the previously detailed variants, the reservoir 21 of at least one syringe 2 and / or the associated tubing 42 has a resistance to a pH lower than 4, preferably lower than 3, ideally lower than 2. The storage of certain solutions is likely to impose particular acidity conditions to ensure the solubility of the components and / or the stability of their compositions, or even to avoid, if not limit, the degradation of one or other of the components of these solutions.Also, it is imperative that the elements of the injection assembly 1 which participate in the storage and / or flow of these solutions are adapted to the acidity constraints of these solutions and eliminate any risk of alteration of the operation of the injection assembly due to the degradation of one or other of the elements in contact with the acidity of a solution in the. reservoir 21 of a syringe 2 or flowing into a tube 42 or into the “Y” connector 6.

[0023] According to an example relating to a construction variant of the injection assembly 1 of the invention capable of being combined with one or other of the previously detailed variants, the reservoir 31 of at least one syringe 3 and / or the associated tubing 43 has a resistance to a pH greater than 10, preferably greater than 11, ideally greater than 12. The storage of certain solutions is likely to impose particular basicity conditions to ensure the solubility of the components and / or the stability of their compositions, or even to avoid, if not limit, the degradation of one or other of the components of these solutions.Also, it is imperative that the elements of the injection assembly 1 which participate in the storage and / or flow of these solutions are adapted to the basicity constraints of these solutions and eliminate any risk of alteration of the operation of the injection assembly due to the degradation of one or other of the elements in contact with the basicity of a solution in the reservoir 21 of a syringe 2 or in flow in a tube 42 or in the “Y” connector 6.

[0024] It should be noted that, when injected into a patient at the administration device by the injection set 1, the final solution must have a pH that is physiologically acceptable for the tissues intended to absorb it. It is therefore preferable for the pH of the final solution to be of the order of 5 or 6 and / or within this range of 5 to 6. When the stability and / or solubility of one or other of the components of the final solution is only likely to allow storage in a solution whose pH level is far from the physiological tolerance range, it is essential that, prior to the injection of the components, the acidity or basicity of the storage solution be reduced to reach a physiologically acceptable pH level.Also, in the context of the injection assembly 1 of the invention, the storage solution which fills a first 21 of the reservoirs of the injection assembly 1 is mixed at the level of the connector “Y >> 6 with a buffer solution stored in a second 31 of the reservoirs of the injection assembly 1 making it possible to compensate for the acidity or basicity of the storage solution. Thus, at the level of the injection pipe 41 at the outlet of the connector “Y >> 6, the final solution produced and flowing up to. the connection interface 7 associated with an administration device has a physiologically acceptable pH level.

[0025] According to an example relating to a construction variant of the injection assembly 1 of the invention capable of being combined with one or other of the previously detailed variants, the reservoir 21, 31 of at least one syringe 2, 3 comprises a wall made of a material whose composition comprises at least one resin of polyethylene type and / or polyolefin plastic type. According to a preferred construction example, the material of at least one of the reservoirs 21, 31 of the syringes 2, 3 of the injection assembly 1 of the invention comprises cyclic olefin copolymers such as, for example, those of the TOPAS® brand. The resins referenced under the name COC TOPAS are thus materials capable of being used for the construction of the reservoirs 21, 31 of one or more of the syringes 2, 3 of the injection assembly 1.Indeed, TOPAS COC resins have resistance properties both to acid solutions, such as hydrochloric acid, sulfuric acid, nitric acid or acetic acid, and to basic solutions such as sodium hydroxide or aqueous ammonia solution. In addition, TOPAS COC resins have the advantage of being sufficiently amorphous to respond positively to the regulatory constraints imposed for direct contact with drug solutions.

[0026] According to an example relating to a construction variant of the injection assembly 1 of the invention capable of being combined with one or other of the previously detailed variants, the reservoir 21, 31 of at least one syringe 2, 3 comprises a piston head 23, 33 made of a material whose composition comprises at least bromobutyl, such as bromobutyl rubber. This type of material allows the production of an elastic seal which is gas-tight, air-tight and moisture-tight, so that the environment inside the reservoir 21, 31 is able to be controlled in particular when the solution present inside the reservoir 21, 31 is likely to be sensitive to a compound of the external environment such as oxygen. Furthermore, this type of material is practically free of organic matter likely to infiltrate or react with the solution present inside the reservoir 21, 31.

[0027] According to an example relating to a construction variant of the injection assembly 1 of the invention capable of being combined with one or other of the previously detailed variants, the reservoir 21, 31 of at least one syringe 2, 3 and / or the “Y” connector 6 and / or at least one tube 41, 42, 43 is made of a material opaque to ultraviolet radiation. To ensure the solubility of the components and / or the stability of the compositions of the stored or flowing solutions, or even to avoid, if not limit, the degradation of one or other of the components of these solutions, it is sometimes necessary to limit if not prevent any interaction of these solutions with certain ranges of light radiation.Also, it is essential that the elements of the injection assembly 1 which participate in the storage and / or flow of these solutions meet the opacity requirements to avoid any accidental alteration of the mixture of solutions produced at the “Y” connector 6 as well as the final solution intended to be injected at the administration device positioned at the end of the injection tubing 41. It should be noted that, at the reservoirs 21, 31 of one or other of the syringes 2, 3, the opacity is likely to be achieved without modification of the material of the reservoir 21, 31. Indeed, the simple positioning of the reservoir 21, 31 in an opaque housing, or even the covering of the external surface of the reservoir 21, 31 with an opaque material, are likely to be sufficient to prevent any undesirable effect resulting from light radiation on the solution contained in the reservoir 21, 31.

[0028] According to an example relating to a construction variant of the injection assembly 1 of the invention capable of being combined with one or other of the previously detailed variants, the injection tubing 41 has a length greater than the respective lengths of the first 42 and second 43 tubings of the injection assembly 1. According to this construction variant, the first 42 and second 43 tubings are arranged so that the “Y” connector 6 is positioned as close as possible to the openings 22, 32 of the syringes 2, 3. Thus, the length of tubing between the syringes 2, 3 and the connection interface 7 is essentially achieved by the injection tubing 41. This construction makes it possible to obtain an injection assembly which limits the size and / or avoids excessively long tubing and therefore reduces the risk of blockage of the flow of one or other of the solutions by accidental pinching of the tubes. Furthermore, such a construction variant makes it possible to allocate the greatest flow length to the final solution intended to be injected so that, during this flow in the injection tube 41, the mixture produced at the level of the “Y” connector 6 is likely to 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 an example relating to a construction variant of the injection assembly 1 of the invention capable of being combined with one or other of the previously detailed variants, the actuation and displacement mechanism 5 comprises at least one rotary motor 51 associated with a threaded shaft 52 which cooperates with a nut 53 to axially move the piston 23, 33 of at least one syringe 2, 3. According to this construction variant, the piston 23, 33 of the displaced syringe 2, 3 is structurally associated with the nut 53 of the actuation mechanism 5 so as to be axially moved with the nut 53 under the effect of the axial pivoting of the threaded shaft 52 driven by the motor 51.

[0030] According to an example relating to a particular variant of the previously detailed example, the pistons 23, 33 of each of the syringes 2, 3 are structurally associated with the nut 53 of the actuating mechanism 5 so as to be moved jointly according to an identical stroke speed driven by the motor 51. In the context of such a construction variant, the syringes 2, 3 and in particular the sections of their respective reservoirs 21, 31, must be arranged to carry out an injection of the respective initial solutions into the first 42 and second 43 tubes in proportions adapted for the production by mixing at the level of the “Y” connector 6 of the final solution intended to be injected.

[0031] According to an example relating to a construction variant of the injection assembly 1 of the invention capable of being combined with one or other of the variants detailed above, the actuation and displacement mechanism 5 comprises: - a rotary motor respectively associated with the axial movement of the piston 23, 33 of each of the syringes 2, 3 by means of a threaded axis in cooperation with a nut, - an interface for controlling and coordinating the axial movement of the piston 23, 33 of each of the syringes 2, 3 connected to each of the rotary motors of the mechanism 5. In the context of such a construction variant, the actuation of each of the syringes 2, 3 is independent thanks to an actuation mechanism 5 which assigns a motor specifically dedicated to each of the syringes 2, 3. Also, the actuation of each of the syringes 2, 3 is likely to be adapted by the control interface according to the sections of the respective reservoirs 21, 31 of each of the syringes 2, 3. This actuation is also likely to be adjusted so that the injections of the respective initial solutions in the, first 42 and second 43, pipes are made according to the desired proportions of these initial solutions in the mixture made at the level of the connector “Y >> 6 to produce the final solution intended to be injected.

[0032] According to an example relating to a construction variant of the injection assembly 1 of the invention capable of being combined with one or other of the previously detailed variants, the actuation and displacement mechanism 5 is arranged to carry out a continuous injection of the final solution at the connection interface 7 at the end of the injection tubing 41 and in particular at the administration device. According to a first implementation variant, the actuation mechanism 5 operates a constant and continuous displacement of the pistons 23, 33 of each of the syringes 2, 3 so that the flow, on the one hand, of each of the initial solutions and, on the other hand, of the final solution along the injection tubing 41 are constant and continuous.However, such a solution requires permanent operation of the motorization of the actuating mechanism 5 for the entire duration of the injection so that, in the context of an ambulatory assembly, an energy reserve for this operation must be provided accordingly. According to a second implementation variant, the actuating mechanism 5 operates a punctual and repeated movement at regular intervals of the pistons 23, 33 of each of the syringes 2, 3. The punctual movement of a piston 23, 33 causes the injection of the solution from the associated reservoir 21, 31 of the syringe 2, 3 into the tubing 42. 43 dedicated. However, taking into account the viscosity of the solutions flowing in the different tubes 41, 42, 43 of the injection assembly 1, the punctual displacement of a piston 23, 33 generates, since the opening of the syringe 2, 3, an overpressure of the localized solution supported by the elasticity of the tubing 42, 43. This overpressure localized at the level of a portion of the tubing 42, 43 is punctual and, between two punctual displacements of the piston 23, 33, gradually fades by the flow of the solutions, initial and final, along the tubings 41, 42, 43 which has the form of a continuous flow at the level of the end of the injection tubing 41 and the connection interface 7.Thus, despite a one-off and repeated actuation and movement of the piston(s) 23, 33 to obtain a progressive and discontinuous emptying of one or more of the reservoirs 21, 31 of the syringes 2, 3, the flow at the end of the injection tubing 41 or the connection interface 7 is likely to be continuous depending on the amplitude of the one-off movement of the piston 23, 33 and the time interval which separates two successive movements of the piston 23, 33. As an example of implementation, one-off movements of the pistons 23, 33 for an injection of 10 μL into the first 42 and second 43 tubings at intervals of 18 seconds are likely to be carried out in an injection assembly 1 according to the invention to obtain a flow rate of the order of 2 ml per hour at the injection tubing 41.

[0033] According to an example relating to a construction variant of the injection assembly 1 of the invention capable of being combined with one or other of the variants detailed above, the actuation and displacement mechanism 5 is associated with a device for detecting an occlusion along at least one of the tubes 41, 42, 43 of the injection assembly 1.

[0034] According to an example relating to a construction variant of the occlusion detection device, this device comprises a pressure sensor positioned along at least one axis of movement of the piston 23, 33 of a syringe 2, 3. Thus, in the event of normal flow of the various solutions, initial and final, in the tubes 41, 42, 43 of the injection assembly 1, the pressure detected by the sensor remains substantially constant during the progression of the piston 23, 33 along its stroke. Occasionally and for a very short period, in particular at the time and just after a punctual movement of the piston 23, 33, the pressure detected by the sensor is likely to exhibit a peak increase followed by a return to a constant pressure value. In case occlusion or obstruction of the flow along one or other of the pipes 41, 42, 43 of the injection assembly 1, the progression of the piston 23, 33 is slowed down, or even stopped, so that jointly the pressure detected by the pressure sensor increases progressively, possibly until reaching a maximum value. Also, as soon as a threshold value detected by the pressure sensor is exceeded, the detection device triggers an alert signal.

[0035] According to an example relating to a construction variant of the occlusion detection device, this occlusion detection device comprises at least one sensor for measuring the effective stroke of at least one piston 23, 33 associated with an algorithm for comparing this effective stroke with a predetermined theoretical stroke. Also, the measurement sensor is associated with an interface for identifying the effective amplitude of movement of a piston 23, 33 and for comparing this effective amplitude with the actual amplitude of movement expected for this same piston 23, 33. Thus, in the case of normal flow of the different solutions, initial and final, in the pipes 41, 42, 43 of the injection assembly 1, the effective amplitude of movement of a piston 23, 33 is similar, or even identical, to the actual amplitude of movement expected for this same piston 23, 33.In the event of amplitude divergence and in the absence of occlusion or obstruction of the flow, the amplitude difference is however intended to remain substantially constant during the progression of the piston 23, 33 along its stroke. The monitoring of this amplitude divergence, during the progression of the movement of the piston 23, 33 concerned, is likely to be associated with a dedicated algorithm. On the other hand, in the event of occlusion or obstruction of the flow along one or other of the pipes 41, 42, 43 of the injection assembly 1, the progression of the piston 23, 33 is slowed down, or even stopped, so that the effective amplitude of movement of a piston 23, 33 diverges from the actual amplitude of movement expected for this same piston 23, 33. Also, the detection device triggers an alert signal.As an example of implementation, the expected actual displacement amplitude may be evaluated or calculated by a particular algorithm associated with the detection device or may be predetermined and recorded in a database associated with the detection device. In a complementary manner, according to a. example of implementation of this detection mechanism, the identification of the amplitude of displacement of the piston 23, 33 is likely to be determined by the evaluation of the displacement pitch of the nut 53 along the threaded axis 52.

[0036] According to an example relating to a construction variant of the injection assembly 1 of the invention capable of being combined with one or other of the variants detailed above, the injection assembly 1 also comprises a reversible connection device between the “Y” connector 6 and the first end of the injection pipe 41. This reversible connection device has the advantage of allowing easy and rapid substitution of the injection pipe 41.Thus, in the event of identification of a problem with the flow of the final solution to be injected up to the end of the injection tubing 41 at the connection interface 7 or even the administration device or in the event of detection of an obstruction of the flow along the injection tubing 41, it is easy to intervene on the injection assembly 1 of the invention to remove the blocked injection tubing 41 and replace it with a new tubing whose end is either connected to a new administration device, such as an infusion device intended to be installed on the patient to be treated, or connected by the corresponding connection interface to the administration device already installed on the patient to be treated, such as an infusion device.

[0037] According to an example relating to a construction variant of the injection assembly 1 of the invention capable of being combined with one or other of the previously detailed variants, the filtration device 8 is of the ceramic cartridge type or in a material of the cellulose acetate or acrylic copolymer or polytetrafluoroethylene or polyether-sulfone type allowing filtration of the order of 0.2 microns. As an example of implementation of this construction variant, the filtration device 8 has a filtering surface of the order of 5 cm 2and allows filtration of 0.22 microns. The choice of a polytetrafluoroethylene polymer makes it possible to obtain a filtration device 8 in the form of a chemically stable and inert microporous film which is suitable for the filtration of products likely to be corrosive. The choice of polyethersulfone makes it possible to obtain a filtration device 8 capable of retaining fine particles, bacteria, fungi from aqueous filtration while having a low rate of adsorption of proteins from the filtered solutions.

[0038] Of course, the invention is not limited to the embodiments described and shown in the attached drawings. Modifications remain possible, particularly from the point of view of the constitution of the various elements or by substitution of technical equivalents, without departing from the scope of protection of the invention.

Claims

Claims

1. Ambulatory injection assembly (1) of a solution obtained by mixing two solutions with specific compositions, characterized in that the injection assembly (1) comprises: - a first syringe (2) whose reservoir (21) is adapted for storing a first solution and whose opening (22) is associated with a first tube (42), - a second syringe (3) whose reservoir (31) is adapted for storing a second solution and whose opening (32) is associated with a second tube (43), - a mechanism (5) for actuating and jointly moving the respective pistons (23, 33) of each of the two syringes (2, 3), - a “Y” connector (6) comprising, on the one hand, two inlets (62, 63) respectively connected to the first tube (42) and to the second tube (43) and, on the other hand, an outlet (61) connected to a first end of an injection tube (41), - a connection interface (7) to an administration device, this connection interface (7) being positioned at a second end of the injection tubing (41), the injection tubing (41) being associated with a filtration device (8) positioned upstream of the connection interface (7) relative to the direction of the injection flow.

2. Injection assembly (1) according to claim 1, characterized in that the injection assembly (1) also comprises an administration device produced by an infusion device associated with the connection interface (7) at the second end of the injection tubing (41). [Claim s] Injection assembly (1) according to one of the preceding claims, characterized in that the injection assembly (1) also comprises a unidirectional flow device (9) positioned downstream of the “Y” connector (6).

4. Injection assembly (1) according to one of the preceding claims, characterized in that the reservoir (21) of at least one syringe (2) and / or the associated tubing (42) has a resistance to a pH of less than 4. [Claim s] Injection assembly (1) according to one of the preceding claims, characterized in that the reservoir (31) of at least one syringe (3) and / or the associated tubing (43) has a resistance to a pH greater than 10.

6. Injection assembly (1) according to one of the preceding claims, characterized in that the reservoir (21, 31) of at least one syringe (2, 3) comprises a wall made of a material whose composition comprises at least one resin of polyethylene type and / or polyolefin plastic type.

7. Injection assembly (1) according to one of the preceding claims, characterized in that the reservoir (21, 31) of at least one syringe (2, 3) comprises a piston head (23, 33) made of a material whose composition comprises at least bromobutyl. [Claim s] Injection assembly (1) according to one of the preceding claims, characterized in that the reservoir (21, 31) of at least one syringe (2, 3) and / or the “Y” connector (6) and / or at least one tube (41, 42, 43) is made of a material opaque to ultraviolet radiation.

9. Injection assembly (1) according to one of the preceding claims, characterized in that the injection pipe (41) has a length greater than the respective lengths of the first (42) and second (43) pipes of the injection assembly (1).

10. Injection assembly (1) according to one of the preceding claims, characterized in that the actuation and displacement mechanism (5) comprises at least one rotary motor (51) associated with a threaded axis (52) which cooperates with a nut (53) to axially move the piston (23, 33) of at least one syringe (2, 3). [Claim 1 1 ] Injection assembly (1 ) according to one of the preceding claims, characterized in that the actuating and moving mechanism (5) comprises: - a rotary motor respectively associated with the axial movement of the piston (23, 33) of each of the syringes (2, 3) by means of a threaded axis in cooperation with a nut, - an interface for controlling and coordinating the axial movement of the piston (23, 33) of each of the syringes (2, 3) connected to each of the rotary motors of the mechanism (5).

12. Injection assembly (1) according to one of the preceding claims, characterized in that the actuation and displacement mechanism (5) is associated with a device for detecting an occlusion along at least one of the tubes (41, 42, 43) of the injection assembly (1).

13. Injection assembly (1) according to claim 12, characterized in that the device for detecting an occlusion comprises a pressure sensor positioned along at least one axis of movement of the piston (23, 33) of a syringe (2, 3).

14. Injection assembly (1) according to claim 12, characterized in that the device for detecting an occlusion comprises at least one sensor for measuring the effective stroke of at least one piston (23, 33) associated with an algorithm for comparing this effective stroke with a predetermined theoretical stroke.

15. Injection assembly (1) according to one of the preceding claims, characterized in that the injection assembly (1) also comprises a reversible connection device between the “Y” connector (6) and the first end of the injection tubing (41).

16. Injection assembly (1) according to one of the preceding claims, characterized in that the filtration device (8) is of the ceramic or cellulose acetate or acrylic copolymer or polytetrafluoroethylene or polyether-sulfone cartridge type allowing filtration of the order of 0.2 microns. |

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