Modular Fluid Delivery System

Abstract

A modular fluid delivery system is disclosed, comprising at least one supply station for supplying at least one fluid and a pressurizing unit for pressurizing the at least one fluid, the pressurizing unit comprising at least one drive unit and at least one disposable pump module assembly. The disposable pump module assembly comprises at least one disposable pump module and fluid circuit tubing. The disposable pump module comprises a support element, the support element defining at least one chamber, at least one inlet fluid circuit pathway, at least one outlet fluid circuit pathway, and at least one recirculation fluid circuit pathway. The fluid circuit tubing comprises at least one inlet fluid circuit tube, at least one outlet fluid circuit tube, and at least one recirculation fluid circuit tube.

Description

[Technical field]

[0001] The present disclosure relates to the field of fluid delivery. More specifically, the present disclosure relates to a modular fluid delivery system that allows for the delivery of at least one fluid under predetermined and desired operating conditions. Even more specifically, the present disclosure relates to a modular injection system for injecting at least one medical fluid and a method of operating the same. [Background technology]

[0002] The background of the present disclosure is presented below with a discussion of technologies relevant to its context. However, this discussion, even if it refers to documents, acts, artifacts, or the like, does not imply or suggest that the discussed technologies are part of the prior art or common general knowledge in the field relevant to the present disclosure.

[0003] Delivery systems for administering liquid compositions by injection or infusion are known in the art.

[0004] For example, in the medical field, liquid medicines or diagnostically active contrast agents are injected or infused into the patient's body (e.g., during a scanning examination such as X-ray, CT, MRI or ultrasound examination), usually into the patient's blood vessels that reach the part of the body or the organ of the patient's body that is to be treated and / or analyzed. In some specific applications, the injected liquid composition may comprise a suspension of microparticles evenly distributed in a liquid carrier, the homogeneity of which is required to be preserved throughout the delivery. Typically, the liquid composition comprises an aqueous suspension of gas-filled microvesicles, i.e., microbubbles bounded by a surfactant-stabilized gas / liquid interface, or microballoons bounded by a substantial material envelope.

[0005] Power injectors and machine-assisted infusion systems for controllably dispensing therapeutically or diagnostically active agents are well known in the art. Typically, such devices include an automatic injector, which has a syringe containing an injectable liquid and a piston that can move in the syringe barrel, ejecting the liquid through the tip and injecting the liquid into a patient through a tube connected to the syringe tip and an injection needle or catheter. To control the injection parameters, the piston is driven with an electromechanical device that pushes the piston continuously or at selected intervals at a desired speed, thereby delivering an amount of drug to the patient's body under precisely defined conditions. For example, in the case of preparations of intravenously administered contrast agents for diagnostic purposes (during X-ray, CT, MRI or ultrasound examinations), the injection speed and mode can be precisely controlled to meet the requirements of the imaging method and detector system used to examine the circulation or a specific organ in the body.

[0006] During administration, it is important for the power injector to control the homogeneity of the liquid composition stored in the syringe barrel, which becomes even more important when the injectable formulation is a suspension or dispersion of active particles that tend to settle, coalesce or separate within the syringe over time. Indeed, even a somewhat modest separation of particles from the carrier liquid due to gravity or other means during the administration stroke of the formulation can have a very significant impact on the reproducibility and reliability of the injection results.

[0007] EP1,035,882B1 and WO2017 / 114706 disclose methods and means for maintaining the homogeneity of syringe contents during injection. In particular, these documents disclose methods for administering to a patient by injecting or infusing a suspension of microparticles homogeneously dispersed in a liquid carrier using an injector system comprising a syringe containing the suspension and a power-driven piston for injecting the suspension into the patient. According to these methods, the suspension contained in the syringe is subjected to a rotational or rocking motion, thereby maintaining the suspension homogeneous by preventing the separation of the microparticles due to gravity or buoyancy, without damaging the particles or preventing their distribution.

[0008] WO2016 / 033351 discloses an infusion system comprising a dual-action infusion pump. The pump comprises a cylinder and a reciprocating piston received within the cylinder, the reciprocating piston separating a first pump chamber of the cylinder from a second pump chamber. A reciprocating motor is coupled to the reciprocating piston, and the first and second pump chambers alternate between filling and discharging states by reciprocation of the reciprocating piston via operation of the reciprocating motor, varying the speed of reciprocation to provide a continuous output of fluid between the first and second pump chambers. A fluid source and a catheter may be coupled to the dual-action infusion pump. The catheter comprises one or more infusion ports near a catheter distal site, the one or more infusion ports receiving and discharging the continuous output of fluid from the dual-action infusion pump.

[0009] WO1990 / 015632 discloses an infusion pump for administering fluid from a fluid source to a patient, the infusion pump comprising a base member having an electric motor for driving a fluid pump housed in a cassette which can be removably mounted on the base member. The cassette houses a reciprocating piston which simultaneously pumps fluid to the patient and draws fluid from the fluid source, thereby maintaining a continuous flow rate. The cassette houses deformable tubing which connects each of the pump's two fluid chambers to an inlet and an outlet of the cassette and provides the necessary valving. The fluid flow rate is adjustably controlled by a microcomputer which regulates the motor by cycling electric motor drive pulses starting at a predetermined time rate and ending when the motor passes one of a number of predetermined positions, so as to maximize flow rate accuracy while maximizing power efficiency.

[0010] DE102011120105 discloses a device having a container with an opening in which a movable piston is arranged. A piston rod is provided for displacing the piston in the container. The container is divided into chambers. A flexible sealing element is provided for closing the opening of the container. Two inlet ducts communicate with the medium supply line and the chambers respectively. Two outlet ducts communicate with the medium supply line and the chambers respectively.

[0011] With regard to the medical field, the injection of fluids into patients is commonplace in some medical procedures. For example, contrast agents (or contrast media) can be injected, possibly together with saline solution, to enhance the contrast of target (body) features (e.g., human body structures or organs) in a patient during a scan thereof. In particular, in imaging applications (where a visual representation of the inside of a patient is created in a non-invasive manner without surgical techniques), the use of contrast agents makes target features more prominent. As a result, it advantageously highlights target features that are otherwise difficult to distinguish from other nearby features (e.g., surrounding tissues). This significantly facilitates the work of clinicians in diagnostic applications, and in particular in identifying and / or characterizing lesions, monitoring their progression or response to medical treatment. For example, iodine-based contrast agents (e.g., containing iopamidol) are commonly used in computed tomography (CT) applications (e.g., angiography).

[0012] The contrast agent is usually injected into the patient's blood vessels, preferably by an automated injection system, which pressurizes and injects the contrast agent into the patient's vascular system or organs under defined injection conditions, e.g., at a defined flow rate and volume. In this way, the contrast agent can be injected in a controlled, safe and efficient manner.

[0013] Thus, the injection system typically comprises one or more supply stations for supplying contrast medium and / or saline solution from corresponding containers (e.g. bottles, bags or pouches). The injection system further comprises a delivery arrangement (i.e. a combination of tubing lines) in fluid communication with at least one supply station and a pressurization unit. As the delivery arrangement is located upstream of the pressurization unit and thus is not directly connected to the patient, there is practically no or very low risk of cross-contamination, and the delivery arrangement is usually a disposable element that is disposed of periodically (e.g. every 10 or 12 hours). This means that the delivery arrangement is not replaced when a new patient is examined, but is typically kept in place for several successive injections (and thus several successive patients) until the predetermined period designed for the delivery arrangement has fully elapsed.

[0014] Powered injection systems known in the art and currently available on the market are categorized into two main groups: syringe injectors (such as the Empower CTA® or Empower CTA®+ manufactured by Bracco Injeneering SA) and syringeless injectors (such as the CT Expres® manufactured by Bracco Injeneering SA).

[0015] Syringe injectors can benefit from syringe / piston technology that ensures very high pressure fluid injection as well as fluid delivery accuracy and precision. Nevertheless, syringe injectors have several drawbacks, mainly related to the cumbersome syringe workflow (in terms of loading and unloading the syringe at the injector head, filling the syringe with the fluid to be injected, priming and purging the syringe), the non-negligible syringe (i.e., disposable) cost, and the cumbersome waste management (i.e., the inevitable discarding of expensive contrast agent that is not injected into the patient and remains in the non-reusable syringe).

[0016] In contrast, syringe-less injectors, by using bottles / bags (instead of syringes), provide a larger amount of contrast available for multiple patient supply, which may benefit from a more efficient and lean workflow since only disposable patient lines are discarded for each new patient, making waste management easier as contrast waste is significantly reduced. Nevertheless, since the main technology used in syringe-less injectors is the peristaltic pump (either as a disposable or reusable peristaltic pump) due to its intrinsic nature, this technology cannot achieve significantly higher pressures and flow rates compared to syringe injectors (especially in disposable versions of peristaltic pumps) and may also experience some adverse fluctuations in flow rate and / or pressure in operation, which may, to some extent, be responsible for the reduced delivery accuracy of the fluid delivery system.

[0017] More recently, some specific medical procedures also require that the power injector be able to provide high demanding hydraulic performance, particularly in terms of pressure and flow rate of the fluid being injected into the patient.

[0018] For example, it is becoming increasingly common for power injectors to be connected to implantable devices (e.g., PICCs & PORTs) that are already implanted within a patient's vascular system and are used to establish intravascular access to the patient.

[0019] A PICC is a Peripherally Inserted Central Catheter that is typically placed in a patient's arm to allow long-term intravenous access, such as long-term antibiotic treatment or chemotherapy. A PICC is inserted into a peripheral vein (e.g., the cephalic, basilic, or brachial vein) and then, while keeping the proximal end of the PICC outside the body, it extends through progressively larger veins toward the heart until the catheter tip reaches the distal superior vena cava or the cave-atrial junction. PICCs are typically left in place in the patient's arm for periods ranging from 6 weeks to 1 year.

[0020] A PORT typically comprises a reservoir (portal) (with a septum for needle insertion) and a catheter that runs from the reservoir into the patient's vein. The reservoir is surgically inserted subcutaneously in the upper chest or arm, and the catheter is inserted completely into the vein, i.e., there is no catheter tail outside the patient's body.

[0021] Thus, some patients who need to undergo imaging examinations (e.g., computed tomography-CT) may already have a PICC&PORT in place for other purposes. Thus, a multi-lumen PICC already in place may be advantageously used by medical personnel for powered injection of diagnostic and / or therapeutic agents. However, the presence of the implanted device necessarily represents a technical constraint for the powered injector (especially a powered syringeless injector) that is required to generate pressure and flow rate values ​​high enough to ensure the desired and predetermined injection performance even when the implanted device is placed between the injection system and the patient.

[0022] Technical fields other than medical applications may likewise require delivery of compositions under specific and defined conditions.

[0023] For example, the adhesive may need to be delivered only if appropriate operating conditions are guaranteed, e.g., if a given homogeneity of the adhesive components is achieved. A dedicated delivery system for applying the adhesive in a given environment must therefore ensure that the adhesive is delivered only if, in fact, said desired homogeneity is obtained, thereby allowing efficient and proper adhesive function.

[0024] Ensuring the desired homogeneity is also required, for example, in processes for the preparation of paint or coating compositions immediately prior to application, especially in the automotive, aerospace and home furnishings industries.

[0025] According to further possible applications, the delivery system may be required to start delivering a given composition only when its particular property threshold is reached, for example when a certain temperature value is reached. The delivery system should therefore ensure that said temperature value is effectively attained and further that an adequate (typically slow) heat distribution occurs within said composition.

[0026] The above-mentioned aspects are not only applicable to traditional industries (e.g., pharmacology, chemical, automotive, aerospace) that require a mixing or shaking step to be performed before the final delivery / application step is performed. Indeed, cell / biological applications may also require that certain conditions be maintained or achieved before moving to the next step. For example, many experiments involving cell cultures use bovine serum, which typically may need to be mixed periodically by careful swirling before use to maintain its native structural state. Summary of the Invention [Problem to be solved by the invention]

[0027] Applicants have therefore recognized a need to improve the ability of fluid delivery systems to deliver fluids that meet specific and predetermined fluid properties required for the proper use of that fluid.

[0028] In other words, the applicant recognizes the need to provide a fluid delivery system that can meet and guarantee the delivery conditions required for a particular fluid to be delivered while ensuring that the delivery system is accurate, efficient, reliable and simple as far as ease of use and its manufacturing process are concerned.

[0029] Furthermore, the applicant has recognised the need to provide a fluid delivery system which makes it possible, if necessary, to reach sufficiently high fluid pressures and to deliver fluid at sufficiently high flow rates, whilst avoiding, or at least greatly limiting, the need to design complex structural solutions for the delivery system to ensure that said sufficiently high fluid pressures and flow rates can ultimately be achieved.

[0030] With particular reference to the medical field, and more specifically with regard to the injection or infusion of a liquid medicament or a diagnostically active contrast agent into a patient's body (typically into the patient's blood vessels leading to a body part or organ of the patient's body that is to be treated and / or analysed via a scanning examination such as, for example, X-ray, CT, MRI or ultrasound examination), the Applicant has recognised the need to improve the hydraulic performance of the power injector (mainly in terms of maximum pressure and maximum flow rate of the injected fluid) so that a given injection procedure is not affected by any possible further medical equipment (e.g. PICC & PORT) that is already implanted in the patient's body and to which the power injector needs to be connected.

[0031] Moreover, the need to improve the hydraulic performance of power injectors also correlates with the fact that, as more viscous contrast agents become available on the market, such increased viscosity generally reduces the delivery performance of the injector in terms of maximum pressure and maximum flow rate of the injected fluid. To make matters worse, sometimes said delivery performance is also adversely affected by the practice in some specific countries of injecting fluids at room temperature, i.e. without pre-warming to about body temperature before injection, which pre-warming actually contributes favorably to reducing the viscosity of the contrast agent.

[0032] The applicant has also recognized the need to improve the delivery performance and accuracy of a fluid delivery system that is required to deliver at least two different fluids having different characteristics / properties (e.g. contrast agents with different viscosities, saline solutions, mixtures thereof) in a sequential and / or alternating manner. Indeed, delivering at least two different fluids in an alternating sequence requires corresponding alternating opening and closing steps of the different fluid pathways through which said fluids are flowed, which may possibly cause the generation of gas bubbles in said fluid pathways due to cavitation reduction, and possibly also negative or overpressure events, which may adversely affect the fluid flow rate, for example, in terms of the desired flow rate values ​​provided by the fluid delivery system and / or in terms of ensuring the regularity and continuity of the fluid flow. Furthermore, the alternating opening and closing steps of the different fluid pathways require valves or clamps to be operated on the high pressure side of the fluid flow, which aspect is very challenging and requires very precise and accurate functioning of the fluid delivery system.

[0033] Applicant also recognizes the need to provide a single fluid delivery system that can meet the various operational applications required by a given customer. For example, where the fluid delivery system is an injector suitable for use in the medical field, Applicant recognizes the need to provide a single device that can be selectively operated to perform, for example, CT, MR and / or angiography examinations, and drug / medicine delivery according to the specific medical needs of a given patient, where said examinations and fluid delivery are traditionally performed using separate dedicated medical equipment (e.g., CT injector, MRI injector, angiography injector, infusion system). [Means for solving the problem]

[0034] A simplified summary of the disclosure is provided herein in order to provide a basic understanding of the disclosure. The sole purpose of this summary is to introduce some concepts of the disclosure in a simplified form as a prelude to the more detailed description below, and it is not intended as an identification of key elements thereof, nor as a delineation of the scope thereof.

[0035] To ensure that predefined delivery requirements for a given fluid are achieved before the fluid begins to be delivered, Applicant has discovered that by properly recirculating the fluid within the fluid delivery system, the desired efficiency and quality thereof can be ensured.

[0036] Furthermore, the applicant has discovered that appropriately redirecting the fluid within the fluid delivery system before delivering it to its exterior provides pressure equalization within the fluid delivery system, which advantageously contributes to easier control of fluid circulation and reduced technical constraints inevitably faced when high pressures arise.

[0037] Furthermore, the applicant has found that recirculating the fluid within a fluid delivery system before it is delivered outside of it can advantageously significantly reduce or even completely eliminate the risk of pressure pulsations, particularly at the start of a fluid delivery procedure.

[0038] Applicant has also discovered that recirculating the fluid within a fluid delivery system before it is delivered outside of the system can advantageously significantly reduce, or even completely eliminate, the latency time of the fluid delivery system, as described in more detail below in this description.

[0039] Furthermore, in order to provide a fluid delivery system capable of delivering at least two different fluids and ensuring that desired / predetermined delivery conditions are accurately and precisely achieved for each fluid (e.g. in terms of pressure and flow rate), the applicant has found to provide a fluid delivery system comprising at least two pump modules, where each pump module processes at least one fluid, and where at least one pump module comprises a dedicated recirculation fluid circuit (sometimes also defined in this description as a recirculation fluid pathway) for internally recirculating at least one fluid to a corresponding pump module when, during operation of the fluid delivery system, it is required that said at least one fluid is not delivered outside the fluid delivery system (i.e. not expelled from said pump module and therefore not delivered by the fluid delivery system).

[0040] The applicant has also found that a single fluid delivery system that can be advantageously used for multiple purposes and adapted to different needs of customers can be designed to be adjustable (i.e., modularly configured) by providing one or more disposable pump module assemblies, each individual disposable pump module assembly having at least one recirculation fluid circuit as described above, adapted to meet a given specific requirement. For example, when the fluid delivery system is applied in the medical field and it is required that two separate fluids are injected into the vascular system of a patient, the applicant has found to provide a modular fluid delivery system (i.e., modular injector) comprising at least one disposable pump module assembly whose technical characteristics are suitable to achieve the desired requirements (e.g., in terms of shape, size, fluid pathway distribution, etc.). The applicant has also found to provide a modular fluid delivery system (i.e., modular injector) that can be adjusted to perform significantly different operations (e.g., CT, MRI or angiography examinations) by using one or more dedicated disposable pump module assemblies.

[0041] According to the present disclosure, the term "disposable" is meant to denote a component of a fluid delivery system that is kept in place and / or used for a limited number of applications or for a limited period of time. For example, if the modular fluid delivery system of the present invention is an injector suitable for application in the medical field, the term "disposable" refers to a component of the fluid delivery system that is used for a predetermined maximum number of patients (e.g., 20-60 patients, or even more) or that is discarded after its installation for a predetermined maximum period of time (e.g., 24 hours). It is meaningful to point out that such indicated time limitations are not directly due to the disposability itself (which may potentially have a virtually infinite lifespan), but are primarily due to the characteristics of the delivered fluid (defects such as crystallization or solidification of the fluid after a predetermined period of time may greatly affect the disposable lifespan). Alternatively, the components of the disposable fluid delivery system may be single-use, i.e., a new component needs to be installed after each injection procedure, which means that a new component is used for any new patient that requires a test procedure. Such single-use applications may be indicated, for example, in the case of delivery of particularly customized mixtures (which may not pose the risk of being contaminated by or of contaminating other different substances delivered to previous or subsequent patients) or in the case of delivery of mixtures which need to be delivered immediately as even a short delay time cannot be tolerated.

[0042] Thus, one aspect of the present disclosure is [1] at least one supply station for supplying at least one fluid; and [2] a pressurizing unit for pressurizing the at least one fluid; A modular fluid delivery system comprising: wherein the pressurizing unit comprises at least one drive unit and at least one disposable pump module assembly; The at least one disposable pump module assembly is characterized by comprising the following [A] and [B]: [A] at least one disposable pump module; wherein the at least one disposable pump module comprises a support element defining: [A-1] at least one chamber for receiving a piston therein; wherein the piston has a plunger which cooperates with an inner wall of the chamber to define first and second variable volume subchambers. [A-2] at least one inlet fluid circuit pathway; [A-3] At least one outlet fluid circuit pathway, and [A-4] At least one recirculation fluid circuit pathway; and [B] A fluid circuit tube comprising: [B-1] at least one inlet fluid circuit tube at least partially received within the at least one inlet fluid circuit pathway; wherein the at least one inlet fluid circuit tube is in fluid communication with the at least one supply station and the at least one chamber for supplying the at least one fluid to the first and second variable volume subchambers. [B-2] at least one outlet fluid circuit tube at least partially received within the at least one outlet fluid circuit pathway; wherein said at least one outlet fluid circuit tube is in fluid communication with said at least one chamber for discharging fluid from either one of said first and second variable volume sub-chambers, said outlet fluid circuit tube being separate from said inlet fluid circuit tube. and [B-3] at least one recirculation fluid circuit tube at least partially received within the at least one recirculation fluid circuit pathway; wherein said at least one recirculation fluid circuit tube fluidly communicates said first and second variable volume subchambers.

[0043] More specifically, one or more aspects of the disclosure are set forth in independent claims and advantageous features thereof are set forth in dependent claims, the language of all claims herein being incorporated by reference verbatim (any advantageous feature provided with respect to any particular aspect applies to all other aspects mutatis mutandis).

[0044] The solutions of the present disclosure, as well as further features and advantages thereof, are best understood with reference to the following detailed description thereof, given purely by way of non-limiting indication, and read in conjunction with the accompanying drawings, in which, for the sake of simplicity, corresponding elements are indicated by equal or similar references, their descriptions are not repeated, and the names of each entity are generally used to indicate both its type and its attributes - e.g., value, content and expression. In this respect, the drawings are not necessarily drawn to scale (some details may be exaggerated and / or simplified) and, unless otherwise indicated, are expressly intended to be used merely to illustrate the structures and procedures conceptually described herein. In particular: [Brief description of the drawings]

[0045] [Figure 1] 1 shows a schematic diagram of a fluid delivery system to which an embodiment of the present disclosure can be applied. [Figure 2-4] 2 shows a schematic diagram of the operational steps of the fluid delivery system shown in FIG. 1. [Diagram 5] 1 shows a schematic diagram of an alternative fluid delivery system to which an embodiment of the present disclosure may be applied. [Figure 6] 1 shows a schematic diagram of a further alternative fluid delivery system to which an embodiment of the present disclosure may be applied. [Figure 7-8] 7 shows a schematic diagram of the operational steps of the fluid delivery system shown in FIG. 6. [Figure 9] FIG. 1 shows a perspective, partially see-through view of one embodiment of a disposable pump module of the present disclosure in which a single fluid circuit pathway is envisioned. [Figure 10]10 shows a perspective view of a disposable pump module assembly including the embodiment of the disposable pump module shown in FIG. 9. [Figure 11-12] 1A and 1B show perspective views of further embodiments of a disposable pump module and a disposable pump module assembly, respectively, of the present disclosure in which two separate fluid circuit pathways are envisaged. [Figure 13-14] FIG. 13 shows a perspective view of a further embodiment of a disposable pump module assembly of the present disclosure in which three separate fluid circuit pathways are envisaged. [Figure 15] 14 shows a perspective view of an alternative embodiment of the disposable pump module assembly depicted in FIGS. 12 and 13. FIG. [Figure 16-17] 1 shows a schematic diagram of a modular fluid delivery system according to the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0046] 1, a schematic diagram of a fluid delivery system 100 according to one embodiment of the present disclosure is shown. The fluid delivery system 100 is used to deliver fluids contained within a supply station 10, said fluids being of different nature based on the particular technical field in which the fluid delivery system is implemented.

[0047] For example, if the fluid delivery system 100 is an injection system for use in the medical field, the fluid contained in the supply station 10 and injected into the vascular system of the patient may be a contrast agent administered to enhance the contrast of target (body) features (e.g., human body structures or organs) within the patient during a scan examination (e.g., during a CT, MRI, or ultrasound examination). In particular, in imaging applications (where a visual representation of the inside of the patient is created in a non-invasive manner without surgical techniques), the use of a contrast agent makes the target features more distinct. As a result, target features that are otherwise difficult to distinguish from other nearby features (e.g., surrounding tissues) are advantageously highlighted. This significantly facilitates the work of the clinician in diagnostic applications, and particularly in identifying and / or characterizing lesions, monitoring their progression or response to medical treatment. For example, in CT applications, the contrast agent may be an iodine-based contrast agent, including diatrizoate, ioxaglate, iopamidol, iohexol, ioxilan, iopromide, or iodixanol. An example of a commercially available contrast agent that contains iopamidol is ISOVUE® manufactured by Bracco Diagnostics Inc.®.

[0048] According to one embodiment of the present disclosure, the fluid delivery system 100 is configured to deliver ultrasound contrast agents (USCA) in a continuous injection / infusion mode and / or as a bolus. In particular, the fluid delivery system 100 is used to deliver a liquid composition comprising a suspension of microparticles uniformly dispersed in a liquid carrier (preferably an aqueous liquid carrier), the microparticles comprising a trapped pure gas or gas mixture comprising at least one physiologically acceptable halogenated gas. The halogenated gas is preferably selected from among CF4, C2F6, C3F8, C4F8, C4F10, C5F12, C6F14 or SF6. The gas mixture may also comprise gases such as air, oxygen, nitrogen, helium, xenon or carbon dioxide. In some cases, the microparticles (microbubbles or microballoons) comprise a mixture of at least one perfluorinated gas with nitrogen or air in a ratio that may vary from 1 to 99%. An example of a commercially available contrast agent used in Contrast Enhanced Ultrasound (CEUS) applications is SonoVue® (sulfur hexafluoride microbubbles) manufactured by Bracco Suisse®.

[0049] With further reference to the medical field, the fluid contained within delivery station 10 and injected into the patient's vascular system can be a physiological or saline solution, including an isotonic solution (e.g., sodium chloride), or the fluid can be a liquid medicine or drug.

[0050] As already mentioned above, the delivery system 100 of the present disclosure can be used to deliver fluids in many technical fields that do not necessarily correlate to the medical / diagnostic field. For example, the fluid contained within the supply station 10 can be an adhesive, a paint formulation, a coating formulation, or any substance / formulation that requires a suitable delivery characteristic (e.g., temperature) to be achieved / controlled.

[0051] The fluid delivery system 100 comprises a pressurizing unit 20 acting on the fluid to leave (and thus be delivered) the fluid delivery system at a predefined pressure and flow rate, preset based on the requirements for a particular delivery application. In detail, the pressurizing unit 20 comprises a pump module 30 and a drive unit M, said drive unit being operationally associated with the pump module. The pump module 30 comprises a chamber 31, in which a piston 32 is reciprocated (i.e. moves back and forth - see double arrow A) by the drive unit M. According to the embodiment shown in the figures, the chamber 31 is represented as a cylindrical barrel (such as a syringe barrel), although other different structures suitable for the purpose can be envisaged as well. The piston 32 comprises a piston rod 33 and a plunger 34, the plunger being arranged substantially perpendicular to the piston rod and having a chamber radial extension, i.e. a radial extension substantially corresponding to the chamber width. Thus, in cooperation with the inner wall of the chamber 31, the plunger 34 defines a first sub-chamber 35 on one side of the plunger (to the left of the plunger in the embodiment of FIG. 1) and a second sub-chamber 36 on the other side of the plunger (to the right of the plunger in the embodiment of FIG. 1). During operation of the fluid delivery system, the piston 32 moves back and forth (see double arrow A), so that the total volume of said first and second sub-chambers 35, 36 changes continuously and alternately, and therefore these sub-chambers are volume-variable sub-chambers. For example, when the piston 32 moves to the right in FIG. 1, the volume of the first sub-chamber 35 increases but the volume of the second sub-chamber 36 decreases; conversely, when the piston 32 moves to the left in FIG. 1, the volume of the second sub-chamber 36 increases but the volume of the first sub-chamber 35 decreases. According to the embodiment shown in FIG. 1, the plunger 34 is provided at the axial end of the piston rod 33 (i.e. the axial end opposite to the axial end connected to the drive unit M).Alternatively, the plunger 34 may be provided at different positions along the longitudinal extension of the piston rod 33, provided that both base walls 31a, 31b of the chamber 31 allow sealed axial movement of the piston rod 33 (embodiment not shown in the figures).

[0052] The fluid delivery system 100 of the present disclosure further comprises an inlet fluid circuit 40, which is in fluid communication with the supply station 10 and the pump module 30. The inlet fluid circuit 40 comprises fluid pathways that supply fluid (contained within the supply station 10) to the first variable volume sub-chamber 35 and the second variable volume sub-chamber 36, such that chamber 31 is filled with the appropriate fluid volume to be delivered (arrow B).

[0053] In particular, inlet fluid circuit 40 comprises a first inlet fluid pathway 41 in fluid communication with supply station 10, said first inlet fluid pathway 41 comprising supply station valve 11 that allows fluid to be discharged from supply station 10. Supply station valve 11 is an active valve operated by the fluid delivery system, as will be explained in detail in the following description.

[0054] Downstream of the supply station valve 11, the inlet fluid circuit 40 branches into a second inlet fluid pathway 42 and a third inlet fluid pathway 43 that are in fluid communication with the first sub-chamber 35 and the second sub-chamber 36, respectively. The first sub-chamber 35 includes a first inlet port 44, thereby placing the second inlet fluid pathway 42 in fluid communication with the first sub-chamber 35. Similarly, the second sub-chamber 36 includes a second inlet port 46, thereby placing the third inlet fluid pathway 43 in fluid communication with the second sub-chamber 36.

[0055] Upstream of the first inlet port 44, the second inlet fluid pathway 42 includes a first inlet fluid circuit valve 45, which allows fluid to flow through the second inlet fluid pathway 42 and into the first sub-chamber 35. According to one embodiment of the present disclosure, the first inlet fluid circuit valve 45 is a check valve, i.e., a one-way valve that allows fluid to flow only in one direction (specifically, from the supply station 10 towards the first sub-chamber 35), thereby preventing fluid from flowing back into the supply station 10.

[0056] Similarly, upstream of the second inlet port 46, the third inlet fluid pathway 43 includes a second inlet fluid circuit valve 47, which allows fluid to flow through the third inlet fluid pathway 43 and into the second sub-chamber 36. According to one embodiment of the present disclosure, the second inlet fluid circuit valve 47 is a check valve, i.e., a one-way valve that allows fluid to flow in only one direction (specifically, from the supply station 10 towards the second sub-chamber 36) without backflow, thereby avoiding fluid from flowing back into the supply station 10.

[0057] Preferably, the first and second inlet fluid circuit valves 45, 47 are ball check valves, with a ball inside the body valve to control fluid flow.

[0058] The fluid delivery system 100 further comprises an outlet fluid circuit 50 separate from the inlet fluid circuit 40. The outlet fluid circuit 50 is in fluid communication with the pump module 30 and comprises a first outlet fluid pathway 51 and a second outlet fluid pathway 52, thereby enabling the fluid delivery system 100 to discharge fluid from the chamber 31 for delivery outside the fluid delivery system (see arrow B). In particular, the first sub-chamber 35 comprises a first outlet port 53, thereby enabling the first outlet fluid pathway 51 to be in fluid communication with the first sub-chamber 35. Similarly, the second sub-chamber 36 comprises a second outlet port 54, thereby enabling the second outlet fluid pathway 52 to be in fluid communication with the second sub-chamber 36. In operation, the first and second outlet fluid pathways 51, 52 of the outlet fluid circuit 50 discharge fluid from either the first sub-chamber 35 or the second sub-chamber 36, as will be described in detail in the present disclosure below.

[0059] Downstream of the first outlet port 53, the first outlet fluid pathway 51 comprises a first outlet fluid circuit valve 55, which allows fluid to be discharged from the first sub-chamber 35 through the first outlet fluid pathway 51. According to one embodiment of the present disclosure, the first outlet fluid circuit valve 55 is a check valve, i.e. a one-way valve that allows fluid to flow in only one direction (specifically out of the first sub-chamber 35) without backflow, thereby avoiding fluid from flowing back into said first sub-chamber 35.

[0060] Similarly, downstream of the second outlet port 54, the second outlet fluid pathway 52 includes a second outlet fluid circuit valve 56, which allows fluid to be discharged from the second sub-chamber 36 through the second outlet fluid pathway 52. ​​According to one embodiment of the present disclosure, the second outlet fluid circuit valve 56 is a check valve, i.e., a one-way valve that allows fluid to flow only in one direction (specifically, out of the second sub-chamber 36), thereby preventing fluid from flowing back into said second sub-chamber 36.

[0061] Preferably, the first and second outlet fluid circuit valves 55, 56 are spring loaded check valves, where a spring component is used to assist in valve operation by eliminating the effect of gravity on the function of the check valves, and more preferably, the first and second outlet fluid circuit valves 55, 56 are spring loaded ball check valves.

[0062] In accordance with the present disclosure, the fluid delivery system 100 further comprises a recirculation fluid circuit 60 fluidly connecting said first and second variable volume subchambers 35, 36, said recirculation fluid circuit 60 cooperating with an actuator 70 for governing the passage of fluid in both directions between said first and second variable volume subchambers 35, 36. The recirculation fluid circuit 60 is an additional fluid circuit, i.e., a further fluid pathway, allowing direct fluid communication between the first and second variable volume subchambers 35, 36. Thus, in this description, the terms "recirculation fluid circuit" or "additional fluid circuit" or "recirculation fluid pathway" are meant to be equivalent to each other and denote the same component of a fluid delivery system.

[0063] 1, the recirculation fluid circuit 60 is external to the chamber 31 and fluidly communicates the separate branches of the inlet fluid circuit 40 upstream of the inlet ports of the sub-chambers 35, 36 and downstream of the inlet fluid circuit valves 45, 47. In particular, a first axial end 61 of the recirculation fluid circuit pathway 60 is in fluid communication with the second inlet fluid pathway 42 of the inlet fluid circuit 40 downstream of the first inlet fluid circuit valve 45. Similarly, a second axial end 62 of the recirculation fluid circuit 60 is in fluid communication with the third inlet fluid pathway 43 of the inlet fluid circuit 40 downstream of the second inlet fluid circuit valve 47.

[0064] The actuator 70 is an active valve operated by the fluid delivery system, as will be explained in detail in the following description. Preferably, the actuator 70 is an electromechanically actuated valve that is automatically controlled and operated by the processor P of the fluid delivery system 100. As shown diagrammatically in the figure, the processor P controls and operates the actuator 70, the drive unit M and the supply station valve 11. In other words, the processor P is a control unit that manages and operates some components of the fluid delivery system according to a predefined delivery (injection) protocol selected by the operator.

[0065] The operation of the delivery system according to the first embodiment of the present disclosure (shown in FIG. 1) is now described with reference to FIGS.

[0066] Supply station 10 contains a fluid (not shown) which must be delivered (arrow B) by delivery system 100 .

[0067] As a first starting step, the method of fluid delivery according to the present disclosure includes filling the first and second sub-chambers 35, 36 with the fluid to be delivered. To perform said filling step, the processor P acts on the drive unit M to open the supply station valve 11, close the actuator 70 of the recirculation fluid circuit 60, and move the piston 32 in the chamber 31, thereby allowing the fluid to flow out of the supply station 10 to the inlet fluid circuit 40. In detail, as soon as the piston 32 moves axially along a first direction (e.g., arrow C in FIG. 2), an under pressure is created in the first sub-chamber (e.g., sub-chamber 35), the volume of which is increasing due to the piston axial movement, and the fluid flows through the first inlet fluid pathway 41 and the second inlet fluid pathway 42 of the inlet fluid circuit 40, flows through the corresponding first inlet fluid circuit valve (e.g., first inlet fluid circuit valve 45), and then enters and fills said first sub-chamber. At the same time, air contained in the second sub-chamber (e.g. sub-chamber 36) (whose volume has decreased due to the piston axial movement) is primed from the delivery system through the venting means of the opposing second inlet fluid circuit valve (e.g. second inlet fluid circuit valve 47). Successively, to fill the second sub-chamber and prime the first sub-chamber, the processor P acts on the drive unit M to reverse the movement of the piston, so that the piston moves axially along a second direction (e.g. arrow D in FIG. 3) opposite to the first direction. As the piston moves, the actuator 70 remains closed, so that a negative pressure is created in the second sub-chamber (e.g. sub-chamber 36) whose volume has increased due to the piston axial movement, causing fluid to flow through the first inlet fluid pathway 41 of the inlet fluid circuit 40, through the corresponding second inlet fluid circuit valve (e.g. second inlet fluid circuit valve 47) and then into and fill said second sub-chamber. At the same time, air still contained in the first sub-chamber (e.g. sub-chamber 35) (whose volume has decreased due to the piston axial movement) is primed out of the delivery system through the venting means of the corresponding first inlet fluid circuit valve (e.g. first inlet fluid circuit valve 45).During the priming step, some fluid exits the delivery system, thereby priming the outlet fluid circuit 50 as well.

[0068] Alternatively, air priming of the fluid delivery system is performed by dedicated venting means (not shown in the drawings) separate from the fluid circuit valves. According to an alternative embodiment, a dedicated venting means is associated with each valve of the fluid delivery system. According to a further embodiment, the fluid delivery system has only one dedicated venting means. Preferably, said only one dedicated venting means is associated with the actuator of the recirculation fluid pathway.

[0069] As soon as the chamber 31 is filled with fluid and priming of the delivery system is completed, the processor P closes the supply station valve 11 and opens the actuator 70 of the recirculation fluid circuit 60 while the drive unit M remains active, maintaining the piston 32 moving axially within the chamber 31.

[0070] Alternatively, processor P opens actuator 70 of recirculation fluid circuit 60 while leaving supply station valve 11 open.

[0071] As the piston 32 moves towards the base wall 31a of the chamber 31 (see arrow C in FIG. 2), the movement of the plunger 34 causes an increase in the volume of the first sub-chamber 35 and a corresponding decrease in the volume of the second sub-chamber 36. Furthermore, because the actuator 70 is in an open position at this stage of the procedure, the fluid initially contained in the second sub-chamber 36 is forced by the plunger 34 out of the chamber 31 through the second inlet port 46 and then into the first sub-chamber 35 by flowing into the recirculation fluid circuit 60 and by passing through the open actuator 70, accessing the first inlet port 44.

[0072] It should be noted that the fluid contained in the second sub-chamber 36 and pushed by the plunger 34 does not flow back into the supply station 10 and does not access the second fluid pathway 52 of the outlet fluid circuit 50. Indeed, the supply station valve 11 is closed and the first and second inlet fluid circuit valves 45, 47 are both one-way valves, allowing fluid to flow from the supply station 10 into the chamber 31 but not vice versa, thereby avoiding fluid discharged from the sub-chamber 36 flowing back up the first and second inlet fluid pathways 41, 42 of the inlet fluid circuit 40. Furthermore, since the second outlet fluid circuit valve 56 automatically opens only when the fluid released from the second sub-chamber 36 has a high enough pressure to overcome the internal elasticity of said valve (preferably the second outlet fluid circuit valve 56 is a ball spring-loaded check valve), when the actuator 70 is in the open state, the fluid released from the second sub-chamber 36 does not have enough force to overcome the internal elasticity of the second outlet fluid circuit valve 56 and therefore the fluid is not delivered outside the fluid delivery system 100; in contrast, the fluid released from the second sub-chamber 36 refills the first sub-chamber 35.

[0073] As soon as the piston 32 reaches its first end stop, i.e. as soon as the plunger 34 completes its axial movement in the first direction (to the right in FIG. 2 - see arrow C) and reaches close to the base wall 31a of the chamber 31 such that the second sub-chamber 36 contains a substantially smaller volume of fluid while the first sub-chamber 35 contains a larger volume of fluid, the processor P acts on the drive unit M to reverse the axial movement of the piston (to the left in FIG. 3 - see arrow D). During the reverse movement of the piston 32 in the chamber 31, the same operating conditions described above apply, i.e. the actuator 70 remains open while the supply station valve 11 remains closed.

[0074] Axial movement of the plunger in the opposite direction causes a volume increase of the second sub-chamber 36 and a corresponding volume decrease of the first sub-chamber 35. Fluid initially contained in the first sub-chamber 35, by virtue of the actuator 70 being in the open position, is forced by the plunger 34 out of the chamber 31 through the first inlet port 44 and then flows into the recirculation fluid circuit 60, through the open actuator 70, through the second inlet port 46 and into the second sub-chamber 36.

[0075] The considerations provided above with respect to the piston movement in a first direction (to the right in FIG. 2 - see arrow C) also apply to the piston movement in a second direction opposite to the first direction (to the left in FIG. 3 - see arrow D). Thus, the fluid contained in the first sub-chamber 35 and pushed out by the plunger 34 does not flow back to the supply station 10 and does not access the first outlet fluid pathway 51 of the outlet fluid circuit 50. In fact, the supply station valve 11 is closed and the first and second inlet fluid circuit valves 45, 47 are both one-way valves, allowing fluid to flow from the supply station 10 to the chamber 31 but not vice versa, thereby avoiding the fluid discharged from the first sub-chamber 35 flowing back through the first and second inlet fluid pathways 41, 42 of the inlet fluid circuit 40. Furthermore, since the first outlet fluid circuit valve 55 automatically opens only when the fluid released from the first sub-chamber 35 has a high enough pressure to overcome the internal elasticity of said valve (preferably the first outlet fluid circuit valve 55 is a ball spring loaded check valve), when the actuator 70 is in the open state, the fluid released from the first sub-chamber 35 does not have enough force to overcome the internal elasticity of the first outlet fluid circuit valve 55 and therefore the fluid is not delivered outside the fluid delivery system 100; in contrast, the fluid released from the first sub-chamber 35 refills the second sub-chamber 36.

[0076] As soon as the piston 32 reaches its second end stop, i.e. as soon as the plunger 34 completes its axial movement in the second direction (to the left in FIG. 3 - see arrow D) and reaches close to the base wall 31b of the chamber 31 such that the first sub-chamber 35 contains a substantially smaller volume of fluid while the second sub-chamber 36 contains a larger volume of fluid, the processor P acts on the drive unit M to reverse the axial movement of the piston again (to the right in FIG. 4 - see arrow C), thereby starting a new charge / discharge cycle of the chamber 31 of the fluid delivery system 100. Of course, any number of cycles can be arranged depending on the requirements of the particular fluid to be delivered and depending on the requirements of the particular application for which the delivery system is implemented.

[0077] It is clear from the above that the fluid delivery system of the present disclosure allows a continuous and predefined movement of the fluid (e.g. in terms of volume, piston movement speed) before it leaves the fluid delivery system. As already mentioned above, this aspect of the present disclosure is particularly advantageous in cases where it is required that certain fluid properties (e.g. homogeneity of the composition, temperature, viscosity, mixing, flowability) are achieved and / or maintained before starting the delivery of the fluid. In fact, the fluid delivery system according to the present disclosure allows the fluid introduced in the chamber 31 to be continuously recirculated by alternately filling / discharging between the first and second sub-chambers 35, 36 when the fluid delivery system 100 is not in delivery, i.e. when the fluid has never left the fluid delivery system. Thanks to the recirculation fluid circuit 60 and the actuator 70 associated therewith, the recirculation of the fluid and its redistribution between the two sub-chambers contributes to the balance of the pressure therein. This aspect is particularly advantageous as it allows the system to be operated at limited (low) pressure, at least in the initial stages when the delivery system is not yet delivering fluid outside the system, thereby limiting the technical constraints that must be met if the system is required to operate at higher pressure values.

[0078] Furthermore, the method of delivery according to the present disclosure includes a step of initiating the delivery of the fluid contained in the chamber 31 (i.e. outside the fluid delivery system). To carry out said step, the processor P closes the actuator 70 of the recirculation fluid circuit 60 and opens the supply station valve 11. Thus, during the delivery of the fluid (fluid leaving the delivery system - see arrow B), the supply station valve 11 is kept open, since it is important to refill the sub-chamber with new fluid in order to avoid fluid perturbations that may affect the correct functioning of the piston and, consequently, the functioning of the entire delivery system. Since closing the actuator 70 prevents any fluid from flowing through the recirculation fluid circuit 60 (while, as already mentioned above, the first and second inlet fluid circuit valves 45, 47 do not allow any backflow of fluid into the supply station 10), pushing the plunger 34 in a first direction (arrow C) and in a second opposite direction (arrow D) allows the fluid to exit the second outlet port 54 and the first outlet port 53, respectively. Thus, when fluid is forced through the second outlet port 54 (arrow C), it flows into the second outlet fluid pathway 52 of the outlet fluid circuit 50 and through the second outlet fluid circuit valve 56 because, at this stage of the procedure, the actuator 70 is closed and the fluid pressure is high enough to overcome the internal elasticity of said second outlet fluid circuit valve 56. Similarly, when fluid is forced through the first outlet port 53 (arrow D), it flows into the first outlet fluid pathway 51 of the outlet fluid circuit 50 and through the first outlet fluid circuit valve 55 because, at this stage of the procedure, the actuator 70 is closed and the fluid pressure is high enough to overcome the internal elasticity of said first outlet fluid circuit valve 55. As a result, fluid is finally delivered by sequentially discharging from the first and second sub-chambers 35, 36 (arrow B). Indeed, because the first and second outlet fluid circuit valves 55, 56 are one-way valves, fluid cannot flow back through the under-pressurized pathway and is therefore forced to be delivered (arrow B).

[0079] As mentioned above, during the step of delivering fluid (arrow B), the supply station valve 11 remains open, thus allowing the fresh fluid to enter the two sub-chambers alternately, without undesired perturbation effects occurring while the piston is moving axially in the chamber 31. It should be noted that, although the fresh fluid entering the system during the delivery step has not passed through the actuator 70 and the recirculating fluid circuit 60, the fresh fluid is not delivered instantly. In fact, the fresh fluid enters the sub-chambers which are under pressure, while the fluid delivered by the system is the fluid contained in the pressurized sub-chambers. Thus, before being delivered, the fresh fluid is permanently moving and mixed in the respective sub-chambers thanks to the axial movement of the piston, thereby ensuring that it reaches the desired delivery conditions before finally leaving the system.

[0080] As already mentioned above, the applicant has found that recirculating the fluid in the chamber 31 by having the fluid flow through the recirculation fluid circuit 60 and the associated actuator 70 can significantly reduce or even completely eliminate the risk of pressure pulsations when the fluid is delivered, especially at the beginning of the fluid delivery procedure. Indeed, the fluid delivery system according to the present disclosure, thanks to the presence of the recirculation fluid circuit 60 and the actuator 70, can adequately control the pressure drops or pressure spikes that occur when the piston 32 starts to move. Indeed, according to the present disclosure, the fluid delivery system starts the delivery of fluid (outside the fluid delivery system) when the recirculation of the fluid in the chamber 31 has already started, and therefore the delivery starts when the piston is already moving in the chamber 31. This clearly means that the start of the fluid delivery is not simultaneous with the piston starting to move, since the delivery of the fluid starts when the piston has already moved axially in the chamber 31 to allow the recirculation of said fluid to take place.

[0081] Moreover, as already mentioned above, the applicant has also found that recirculating the fluid in the chamber 31 by allowing the fluid to flow through the recirculation fluid circuit 60 and the associated actuator 70 can significantly reduce or even completely eliminate the delay time of the fluid delivery system. The delay time is the technical time that the fluid delivery system necessarily needs to prepare to deliver the fluid. Indeed, as soon as the processor P issues an instruction to send a current to the drive unit M, said current typically creates an electromagnetic field that acts on the rotor magnet, which produces a torque on the gear, which causes the piston to start moving. Once the piston starts moving, a fluid pressure is created, which nevertheless requires some additional time to reach and overcome the pressure thresholds set for the first and second outlet fluid circuit valves 55, 56. The sum of all these times is called the "delay time", which can never be ignored, and which necessarily causes a delay in the fluid delivery out of the fluid delivery system. By virtue of the presence of the recirculation fluid circuit 60 and associated actuator 70, the fluid delivery system 100 of the present disclosure is able to overcome or reduce said delay time since the piston 32 begins to move well in advance of fluid delivery to effect recirculation of the fluid within the chamber 31. Thus, as soon as the processor P closes the actuator 70 to begin fluid delivery (arrow B), the fluid pressure increases immediately and quickly overcomes the pressure thresholds set for the first and second outlet fluid circuit valves 55, 56. As a result, fluid is delivered by the system immediately after the processor P commands delivery to begin.

[0082] 5, a schematic diagram of a further fluid delivery system 200 according to an alternative embodiment of the present disclosure is shown in which two pump modules 230, 230′ are arranged in parallel. The fluid delivery system 200 is used to deliver a first fluid contained in a first supply station 210 and a second fluid contained in a second supply station 210′, where the first fluid and the second fluid are different from each other.

[0083] When the fluid delivery system 200 is an injection system for use in the medical field, a first fluid contained in the first supply station 210 and injected into the vascular system of a patient can be, for example, a contrast agent, while a second fluid contained in the second supply station 210' can be a physiological or saline solution including an isotonic solution (e.g., sodium chloride). Alternatively, the first fluid and / or the second fluid can be a liquid medicine or drug.

[0084] As already mentioned above, the fluid delivery system 200 of the present disclosure can be used to deliver fluids in many technical fields that do not necessarily correlate strictly to the medical / diagnostic field. For example, the first and second fluids contained in the first and second supply stations 210 and 210', respectively, can be two or more component adhesives, paint formulations, coating formulations, or any substance / formulation that requires the delivery characteristics (e.g., temperature) to be appropriately achieved / controlled.

[0085] The fluid delivery system 200 comprises a pressurizing unit 220, which operates on the first and second fluids so that they are alternately delivered outside the fluid delivery system (at a predefined pressure and flow rate preset by an operator or a fluid delivery system processor / control unit based on the requirements designed for a particular delivery application) and recirculated within the fluid delivery system (disclosed in detail in the following description). The pressurizing unit 220 comprises a first pump module 230, a second pump module 230' and a drive unit M associated with the two pump modules for their operation / actuation. Each pump module 230, 230' comprises a chamber 231, 231', respectively, in which a piston 232, 232' is reciprocated (i.e. moved back and forth - see double arrows E, E') by the drive unit M. According to the embodiment shown in the figure, the chambers 231, 231' are represented as cylindrical barrels (e.g. syringe barrels, etc.), but other different structures suitable for the purpose can be envisaged as well. Each piston 232, 232' comprises a piston rod 233, 233' and a plunger 234, 234', respectively, which is arranged substantially perpendicular to the piston rod and has a radial extension which substantially corresponds to the chamber radial extension (i.e. the chamber width). Each plunger 234, 234' thus defines, in cooperation with the inner wall of said chamber 231, 231', a respective first sub-chamber 235, 235' on one side of the plunger (to the left of the plunger in the embodiment of FIG. 5) and a respective second sub-chamber 236, 236' on the opposite side of the plunger (to the right of the plunger in the embodiment of FIG. 5). During operation of the fluid delivery system 200, the pistons 232, 232' move back and forth (see double arrows E, E') and thus the total volume of said first 235, 235' and second 236, 236' sub-chambers changes continuously and alternatingly, these sub-chambers being variable volume sub-chambers.For example, when the pistons 232, 232' move to the right in Fig. 5, the volume of the first sub-chamber 235, 235' increases but the volume of the second sub-chamber 236, 236' decreases; conversely, when the pistons 232, 232' move to the left in Fig. 5, the volume of the second sub-chamber 236, 236' increases but the volume of the first sub-chamber 235, 235' decreases. According to the embodiment shown in Fig. 5, the plungers 234, 234' are provided at the axial ends of the piston rods 233, 233' (i.e. the axial ends opposite to the axial ends connected to the drive unit M). Alternatively, the plungers 234, 234' may be provided at different positions along the longitudinal extension of the piston rods 233, 233' (embodiments not shown in the figures), provided that the base walls 231a, 231b of the chamber 231 as well as the base walls 231a', 231b' of the chamber 231' permit sealed axial movement of the piston rods 233, 233' therethrough (i.e. through said chambers).

[0086] The fluid delivery system 200 of the present disclosure further comprises a first inlet fluid circuit 240 and a second inlet fluid circuit 240'. In particular, the first inlet fluid circuit 240 is in fluid communication with the first supply station 210 and the first pump module 230, while similarly the second inlet fluid circuit 240' is in fluid communication with the second supply station 210' and the second pump module 230'. The first inlet fluid circuit 240 comprises an inlet fluid pathway that delivers the first fluid (contained within the first supply station 210) to the first variable volume sub-chamber 235 and the second variable volume sub-chamber 236 such that the chamber 231 is filled with an appropriate volume of the first fluid to be delivered outside the fluid delivery system 200 (arrow F). Similarly, the second inlet fluid circuit 240' includes an inlet fluid pathway that supplies a second fluid (contained within the second supply station 210') to the first variable volume sub-chamber 235' and the second variable volume sub-chamber 236' such that the chamber 231' is filled with an appropriate volume of the second fluid that is delivered outside the fluid delivery system 200 (arrow F').

[0087] In particular, the first and second inlet fluid circuits 240, 240' comprise first inlet fluid pathways 241, 241' in fluid communication with the supply stations 210, 210', said first inlet fluid pathways 241, 241' comprising supply station valves 211, 211' that allow the respective fluids to be discharged from the supply stations 210, 210'. The supply station valves 211, 211' are active valves operated by the fluid delivery system, as will be explained in more detail below in this description.

[0088] Downstream of the supply station valves 211, 211', the first and second inlet fluid circuits 240, 240' branch into second inlet fluid pathways 242, 242' and third inlet fluid pathways 243, 243' in fluid communication with the first sub-chambers 235, 235' and second sub-chambers 236, 236', respectively. The first sub-chambers 235, 235' include first inlet ports 244, 244' that allow the second inlet fluid pathways 242, 242' to be in fluid communication with the first sub-chambers 235, 235'. Similarly, the second sub-chambers 236, 236' include second inlet ports 246, 246' that allow the third inlet fluid pathways 243, 243' to be in fluid communication with the second sub-chambers 236, 236'.

[0089] Upstream of the first inlet ports 244, 244', the second inlet fluid pathway 242, 242' includes a first inlet fluid circuit valve 245, 245', which allows the respective fluids (i.e., the first fluid exiting the first supply station 210 and the second fluid exiting the second supply station 210') to flow through the second inlet fluid pathway 242, 242' into the first sub-chamber 235, 235'. According to one embodiment of the present disclosure, the first inlet fluid circuit valve 245, 245' is a check valve, i.e., a one-way valve that allows fluid to flow only in one direction (specifically, from the supply station 210, 210' towards the first sub-chamber 235, 235') and prevents fluid from flowing back into the supply station 210, 210'.

[0090] Similarly, upstream of the second inlet ports 246, 246', the third inlet fluid pathway 243, 243' includes a second inlet fluid circuit valve 247, 247', which allows the respective fluids (i.e., the first fluid exiting the first supply station 210 and the second fluid exiting the second supply station 210') to flow through the third inlet fluid pathway 243, 243' into the second sub-chamber 236, 236'. According to one embodiment of the present disclosure, the second inlet fluid circuit valve 247, 247' is a check valve, i.e., a one-way valve that prevents backflow, thereby allowing fluid to flow in only one direction (specifically, from the supply station 210, 210' towards the second sub-chamber 236, 236') and avoiding fluid backflow into the supply station 210, 210'.

[0091] Preferably, the first 245, 245' and second 247, 247' inlet fluid circuit valves are ball check valves, with a ball inside the body valve to control fluid flow.

[0092] The fluid delivery system 200 of the present disclosure further comprises a first outlet fluid circuit 250 (separate from the first inlet fluid circuit 240) and a second outlet fluid circuit 250' (separate from the second inlet fluid circuit 240'). In particular, the first outlet fluid circuit 250 is in fluid communication with the first pump module 230, and similarly, the second outlet fluid circuit 250' is in fluid communication with the second pump module 230'. Both the first and second outlet fluid circuits 250, 250' comprise first outlet fluid pathways 251, 251' and second outlet fluid pathways 252, 252', respectively, enabling the fluid delivery system 200 to expel the first fluid from the chamber 231 (see arrow F) and the second fluid from the chamber 231' (see arrow F'). In particular, the first sub-chamber 235, 235' includes a first outlet port 253, 253', thereby allowing a first outlet fluid pathway 251, 251' to be in fluid communication with said first sub-chamber 235, 235'. Similarly, the second sub-chamber 236, 236' includes a second outlet port 254, 254', thereby allowing a second outlet fluid pathway 252, 252' to be in fluid communication with said second sub-chamber 236, 236'. As will be described in detail in the disclosure below, in operation the first 251, 251' and second 252, 252' outlet fluid pathways of the outlet fluid circuits 250, 250' discharge a first fluid from either the first sub-chamber 235 or the second sub-chamber 236, and similarly discharge a second fluid from either the first sub-chamber 235' or the second sub-chamber 236'.

[0093] Downstream of the first outlet port 253, 253', the first outlet fluid pathway 251, 251' comprises a first outlet fluid circuit valve 255, 255', which allows the first and second fluids to be discharged from the first sub-chamber 235, 235' through the first outlet fluid pathway 251, 251' and from the second sub-chamber 236, 236' through the second outlet fluid pathway 252, 252', respectively. According to one embodiment of the present disclosure, the first outlet fluid circuit valve 255, 255' is a check valve, i.e. a one-way valve that prevents backflow, thereby allowing fluid to flow only in one direction (specifically out of the first sub-chamber 235, 235') and avoiding fluid backflow into said first sub-chamber 235, 235'.

[0094] Similarly, downstream of the second outlet port 254, 254', the second outlet fluid pathway 252, 252' includes a second outlet fluid circuit valve 256, 256', which allows the first and second fluids to exit the second sub-chamber 236, 236' through the second outlet fluid pathway 252, 252', respectively. According to one embodiment of the present disclosure, the second outlet fluid circuit valve 256, 256' is a check valve, i.e., a one-way valve that allows fluid to flow only in one direction (specifically, out of the second sub-chamber 236, 236'), thereby preventing fluid from flowing back into said second sub-chamber 236, 236'.

[0095] Preferably, the first 255, 255' and second 256, 256' outlet fluid circuit valves are spring loaded check valves, where a spring component is used to aid in valve operation by eliminating the effect of gravity on the function of the check valves. More preferably, the first 255, 255' and second 256, 256' outlet fluid circuit valves are spring loaded ball check valves.

[0096] 5, the fluid delivery system 200 of the present disclosure further comprises a first recirculation fluid circuit 260 and a second recirculation fluid circuit 260', which are also referred to in the present description as additional fluid circuits (i.e., additional fluid circuits to the inlet and outlet fluid circuits described above). In particular, the first recirculation fluid circuit 260 fluidly communicates the first and second variable volume sub-chambers 235, 236 of the chamber 231 of the first pump module 230, and said first recirculation fluid circuit 260 cooperates with a first actuator 270 (included in said first recirculation fluid circuit 260) for governing the passage of a first fluid in both directions between said first and second variable volume sub-chambers 235, 236. Similarly, a second recirculation fluid circuit 260' fluidly connects the first and second variable volume sub-chambers 235', 236' of the chamber 231' of the second pump module 230', said second recirculation fluid circuit 260' cooperating with a second actuator 270' (included in said second recirculation fluid circuit 260') for controlling the passage of a second fluid in both directions between the first and second variable volume sub-chambers 235', 236'.

[0097] 5, the first and second recirculation fluid circuits 260, 260' are external to the chambers 231, 231' and they fluidly communicate the separate branches of the first and second inlet fluid circuits 240, 240', respectively, upstream of the inlet ports 244, 244' and 246, 246' of the respective sub-chambers 235, 235' and 236, 236'. In particular, with respect to the first pump module 230, a first axial end 261 of the first recirculation fluid circuit 260 is in fluid communication with the second inlet fluid pathway 242 of the first inlet fluid circuit 240 downstream of its first inlet fluid circuit valve 245, while a second axial end 262 of the first recirculation fluid pathway 260 is in fluid communication with the third inlet fluid pathway 243 of the first inlet fluid circuit 240 downstream of its second inlet fluid circuit valve 247. Similarly, with respect to the second pump module 230', a first axial end 261' of the second recirculation fluid circuit 260' is fluidly connected to a second inlet fluid pathway 242' of the second inlet fluid circuit 240' downstream of its first inlet fluid circuit valve 245', while a second axial end 262' of the second recirculation fluid circuit 260' is fluidly connected to a third inlet fluid pathway 243' of the second inlet fluid circuit 240' downstream of its second inlet fluid circuit valve 247'.

[0098] The first and second actuators 270, 270' are active valves operated by the fluid delivery system 200, as will be explained in detail in the following description. Preferably, the first and second actuators 270, 270' are electromechanically actuated valves that are automatically controlled and operated by a processor or control unit P of the fluid delivery system 200. As shown diagrammatically in the figure, the processor P controls and operates the first and second actuators 270, 270', the actuation unit M, and the first and second supply station valves 211, 211'.

[0099] According to an alternative embodiment shown in Figure 6, a fluid delivery system 200' is represented diagrammatically, in which the two pump modules 230, 230' are arranged in series, rather than in parallel as shown in the embodiment of Figure 5. In this alternative embodiment, the two chambers 231, 231' are separate and spaced apart from each other, but a common piston rod 233 having two spaced apart plungers 234, 234' is provided in the chambers 231, 231', thereby defining respective first 235, 235' and second 236, 236' variable volume sub-chambers. All remaining components (and their functions) of the alternative embodiment are identical to the respective components of the fluid delivery system 100 shown in Figure 5, and are therefore indicated with the same reference numerals.

[0100] The operation of the alternative fluid delivery system shown in Figure 6 according to the present disclosure is described below with respect to applications in the medical field, more specifically with respect to alternate or simultaneous injection of contrast agent and saline solution for diagnostic purposes. However, as already mentioned above in this description, the fluid delivery system according to the present disclosure can be used in other technical areas that do not correlate to medical / healthcare applications. Furthermore, the general operational principles (described herein below with respect to some embodiments of the delivery system of the present disclosure) are applicable to multiple embodiments disclosed in this description and / or shown in the figures related thereto.

[0101] As an example of a method of operating the alternative fluid delivery system according to the present disclosure, reference is made to FIGS. 7 and 8, which illustrate a fluid delivery system 200' according to the embodiment shown in FIG.

[0102] Supply station 210 contains a first fluid (not shown), e.g., contrast agent, that is desired to be injected (see arrow F) into the patient by delivery system 200', while supply station 210' contains a second fluid (not shown), e.g., saline solution, that is desired to be injected (see arrow F') into the patient by said delivery system 200'. Typically, the first fluid exiting at F and the second fluid exiting at F' are conveyed to the patient through a common tube (patient line - not shown) that is mechanically and fluidly connected to a catheter and / or needle for accessing the patient's vascular system.

[0103] As a first starting step, the method of delivery according to the present disclosure includes filling the first and second sub-chambers 235, 236 of the first pump module 230 with a first fluid, and similarly filling the first and second sub-chambers 235', 236' of the second pump module 230' with a second fluid. To perform said filling steps, the processor P acts on the drive unit M to open the supply station valves 211, 211', close the actuators 270, 270' of the first and second recirculation fluid circuits 260, 260', and reciprocate the common piston 232 in the chambers 231, 231', thereby allowing the first and second fluids to exit the supply stations 210, 210', respectively, and to flow through the first inlet fluid circuit 240 and the second inlet fluid circuit 240'. In detail, as soon as the piston 232 is moved axially along a first direction (e.g., arrow G in FIG. 7), an under-pressure is created in the first sub-chamber (e.g., sub-chamber 235, 235') whose volume is increasing due to the piston axial movement. Thus, the respective fluid can flow through the first 241, 241' and second 242, 242' of the first and second inlet fluid circuits 240, 240' through the corresponding first inlet fluid circuit valve (e.g., first inlet fluid circuit valve 245, 245') and then enter and fill said first sub-chamber. At the same time, air contained in the second sub-chamber (e.g., sub-chamber 236, 236') (whose volume is decreasing due to the piston axial movement (arrow G)) is primed from the fluid delivery system through the venting means of the opposite second inlet fluid circuit valve (e.g., second inlet fluid circuit valve 247, 247'). Indeed, air contained within the first sub-chamber 235, 235' is generally evacuated from the sub-chamber through the first inlet port 244, 244', then through the second inlet fluid pathway 242, 242', and finally through the first inlet fluid circuit valve 245, 245'.Successively, to fill the second sub-chamber with the respective fluid and to prime the first sub-chamber (i.e. to expel air therefrom), the processor P acts on the drive unit M to reverse the movement of the piston so that it moves axially along a second direction (e.g. arrow H in FIG. 8 ) opposite to the first direction. While the piston is moving during the filling and priming steps, the actuators 270, 270′ remain closed, so that an under-pressure is created in the second sub-chamber (e.g. sub-chamber 236, 236′) whose volume is increasing due to the piston axial movement (arrow H). Thus, the first and second fluids can flow through the first 241, 241′ and third 243, 243′ inlet fluid pathways of the first and second inlet fluid circuits 240, 240′, respectively, through the corresponding second inlet fluid circuit valve (e.g. second inlet fluid circuit valve 247, 247′) and then enter and fill said second sub-chamber. At the same time, the air still contained in the first sub-chamber (e.g. sub-chamber 235, 235') whose volume has been reduced due to the piston axial movement (arrow H) is primed out of the fluid delivery system through the venting means of the corresponding first inlet fluid circuit valve (e.g. first inlet fluid circuit valve 245, 245'). In fact, the air contained in said second sub-chamber 236, 236' is generally forced out of said sub-chamber by passing through the second inlet port 246, 246', then through the third inlet fluid pathway 243, 243' and finally through the second inlet fluid circuit valve 247, 247'. During the priming step, some amount of the first and second fluids exits the fluid delivery system through the first 250 and second 250' outlet fluid circuits, so that the priming of said first 250 and second 250' outlet fluid circuits can also be properly performed.

[0104] Alternatively, air priming of the fluid delivery system is performed by dedicated venting means (not shown) separate from the fluid circuit valves. According to an alternative embodiment, a dedicated venting means is associated with each valve of the fluid delivery system. According to a further alternative embodiment, a dedicated venting means is associated with each actuator 270, 270' of the first and second recirculation fluid circuits 260, 260'.

[0105] As soon as the chambers 231, 231' are filled with the first and second fluids, respectively, and priming of the fluid delivery system is completed, the processor P closes the supply station valves 211, 211' and opens the actuators 270, 270' of the first and second recirculation fluid circuits 260, 260' while the drive unit M is still operating, thereby continuing to move the piston 232 axially (arrows G and H) within the chambers 231, 231'. Alternatively, the processor P opens the actuators 270, 270' of the first and second recirculation fluid circuits 260, 260' while the supply station valves 211, 211' maintain an open operating state as the two fluids are recirculated within the respective chambers 231, 231'.

[0106] By maintaining the actuators 270, 270' of the first and second recirculation fluid circuits 260, 260' in an open operative state, the fluid delivery system 200' avoids delivering the first and second fluids to the outside thereof. Indeed, thanks to the open operative state of the actuators 270, 270' and the axial movement of the piston 232, the first fluid is continuously recirculated in the first chamber 231 through the first recirculation fluid circuit 260, and the second fluid is continuously recirculated in the second chamber 231' through the second recirculation fluid circuit 260'. In particular, when the piston 232 moves in a first direction (e.g., arrow G in FIG. 7), the first fluid contained in the second sub-chamber 236 is forced out through its second inlet port 246 and then through the first recirculation fluid circuit 260 and the first actuator 270 into the first sub-chamber 235 at its first inlet port 244. At the same time, the second fluid contained within the second sub-chamber 236' is forced out through its second inlet port 246', then through the second recirculation fluid circuit 260' and the second actuator 270', and into the first sub-chamber 235' at its first inlet port 244'.

[0107] Thereafter, when the piston 232 reaches its first end stop, i.e. when the plunger 234 completes its axial movement in said first direction (to the right in FIG. 7 - see arrow G) and reaches near the base wall 231 a of the chamber 231 and at the same time the plunger 234′ reaches near the base wall 231 a′ of the chamber 231′, the processor P acts on the drive unit M to reverse the axial movement of the piston (to the left in FIG. 8 - see arrow H). Similar to the first run of the piston described above, the first fluid contained in the first sub-chamber 235 is forced out through its first inlet port 244 and then through the first recirculation fluid circuit 260 and the first actuator 270 into the second sub-chamber 236 at its second inlet port 246. At the same time, the second fluid contained within the first sub-chamber 235' is forced out through its first inlet port 244', then through the second recirculating fluid circuit 260' and the second actuator 270', and into the second sub-chamber 236' at its second inlet port 246'.

[0108] Then, as soon as the piston 232 reaches its second end stop, i.e. as soon as the plungers 234, 234' have completed their axial movement in the second direction (to the left in FIG. 8 - see arrow H) and are close to the base walls 231b, 231b' of the respective chambers 231, 231' (so that the first sub-chambers 235, 235' contain a substantially smaller volume of the respective fluid, while the second sub-chambers 236, 236' contain a larger volume of the respective fluid), the processor P acts on the drive unit M to reverse the axial movement of the piston again (to the right in FIG. 7 - see arrow G), thereby initiating a new filling / discharging cycle of the chambers 231, 231' of the fluid delivery system 200'. Of course, any number of cycles can be arranged depending on the requirements of the particular fluid to be delivered and the particular application for which the fluid delivery system is implemented. As already mentioned above, said initial recirculation step of the two fluids in their respective chambers is particularly advantageous as it makes it possible to keep the two fluids moving within the fluid delivery system, thereby ensuring that each single fluid is properly and uniformly mixed prior to its delivery.

[0109] It should be noted that the fluid contained within the second sub-chambers 236, 236' and expelled by the plungers 234, 234' does not flow back into the supply stations 210, 210' and does not access the second outlet fluid pathways 252, 252' of the first and second outlet fluid circuits 250, 250'. Indeed, preferably, the supply station valves 211, 211' are closed and furthermore the first 245, 245' and second 247, 247' inlet fluid circuit valves are both one-way valves allowing liquid to flow from the supply stations 210, 210' into their respective chambers 231, 231' but not vice versa, thereby avoiding fluid discharged from the first 235, 235' and second 236, 236' sub-chambers from flowing back through the first 241, 241' and second 242, 242' inlet fluid pathways of the first and second inlet fluid circuits 240, 240'. Furthermore, since the first 255, 255' and second 256, 256' outlet fluid circuit valves automatically open only when the fluid discharged from the first 235, 235' and second 236, 236' sub-chambers, respectively, has a high enough pressure to overcome the internal elasticity of said valves (preferably the first and second outlet fluid circuit valves are ball spring loaded check valves), when the actuators 270, 270' are in the open state, the fluid discharged from the first 235, 235' and second 236, 236' sub-chambers does not have sufficient force to overcome the internal elasticity of the first 255, 255' and second 256, 256' outlet fluid circuit valves and therefore the fluid is not delivered outside the fluid delivery system 200' but is recirculated within their respective sub-chambers.

[0110] It is clear from the above that said alternative embodiment of the fluid delivery system of the present disclosure allows for a continuous and predefined movement (e.g. in terms of volume, piston movement speed) of one or both fluids before exiting the fluid delivery system. As already mentioned above, this aspect of the present disclosure is particularly advantageous when certain fluid properties (e.g. composition homogeneity, temperature, viscosity, mixing, flowability) are required to be achieved and / or maintained before starting the delivery of that fluid. In fact, the fluid delivery system according to the present disclosure allows for the fluids introduced into the first 231 and second 231' chambers to be continuously recirculated by alternately filling / discharging between the first 235, 235' and second 236, 236' sub-chambers when the fluid delivery system 200' is not in delivery, i.e. when the fluid has never left the fluid delivery system. Thanks to the first 260 and second 260' recirculation fluid circuits and the first 270 and second 270' actuators associated therewith, the recirculation of the fluid and its redistribution between the two sub-chambers contributes to the balancing of the pressure therein. This aspect is particularly advantageous as it allows the system to be operated at a limited (low) pressure, at least in the initial stages when the delivery system has not yet delivered any fluid outside the system, thereby limiting the technical constraints that must be met if the system is required to operate at higher pressure values.

[0111] As soon as the recirculation is completed (e.g. the desired homogeneity of one or both fluids has been successfully reached and at a particular point in time delivery of the first and / or second fluid is required to commence), the processor P acts appropriately on the first actuator 270 or the second actuator 270' to close it (them) and stop the recirculation step of at least one of the first and second fluids.

[0112] For example, if a first fluid contained within supply station 210 is requested to be delivered first, processor P closes first actuator 270 of first recirculation fluid circuit 260, while second actuator 270' of second recirculation fluid circuit 260' remains maintained in its open actuated state, thereby allowing delivery of the first fluid (arrow F) to be performed, while the second fluid continues to recirculate within its respective chamber 231'. This is the case, for example, when, at a given time of an injection / infusion process performed on a given patient undergoing an examination procedure (e.g., a CT diagnostic examination), fluid delivery system 200' is requested to deliver only the first fluid (e.g., contrast agent) contained within supply station 210, while performing a recirculation of the second fluid (e.g., saline solution) (i.e., the second fluid is not delivered outside the fluid delivery system at that time).

[0113] Thus, the method of delivery according to the present disclosure comprises a step of initiating the delivery of a first fluid contained in the first chamber 231 (i.e. outside the fluid delivery system). To carry out said step, as described above, the processor P closes the first actuator 270 of the first recirculation fluid circuit 260 and opens the first supply station valve 211. During the delivery of the first fluid (fluid leaving the fluid delivery system - see arrow F), the first supply station valve 211 is maintained in its open state, since it is important to refill the sub-chambers 235, 236 of the first chamber 231 with new first fluid in order to avoid fluid perturbations that could possibly affect the correct functioning of the piston and, consequently, the functioning of the entire fluid delivery system. Since closing the first actuator 270 prevents the first fluid from flowing through the first recirculation fluid circuit 260 (while, as already mentioned above, the first and second inlet fluid circuit valves 245, 247 do not allow any backflow of the first fluid to the first supply station 210), pushing the first plunger 234 in a first direction (arrow G in FIG. 7 ) and in a second opposite direction (arrow H in FIG. 8 ) allows the first fluid to exit the second outlet port 254 and the first outlet port 253 of the first chamber 231, respectively. Thus, when the first fluid is pushed through the second outlet port 254 (arrow G), the first fluid flows into the second outlet fluid pathway 252 of the first outlet fluid circuit 250 and through the second outlet fluid circuit valve 256. Because, at this stage of the procedure, the first actuator 270 is closed, the fluid pressure is high enough to overcome the internal elasticity of said second outlet fluid circuit valve 256. Similarly, when the first fluid is forced through the first outlet port 253 (arrow H), the first fluid flows into the first outlet fluid pathway 251 of the first outlet fluid circuit 250 and through the first outlet fluid circuit valve 255 because, at this stage of the procedure, the first actuator 270 is closed and the fluid pressure is high enough to overcome the internal elasticity of said first outlet fluid circuit valve 255.As a result, the first fluid is finally delivered (arrow F) by sequentially discharging from the first and second sub-chambers 235, 236 of the first chamber 231. Indeed, since the first and second outlet fluid circuit valves 255, 256 are one-way valves, the first fluid cannot flow back through the under-pressurized pathway and is therefore necessarily forced to be delivered (arrow F).

[0114] It can be noted that the method of delivery according to the present disclosure does not necessarily require the sub-chambers 235, 236 to be completely filled with the first fluid or to completely expel the first fluid. In other words, it is not mandatory for the first plunger 234 to reach the base wall 231a, 231b of the first chamber 231 during its back and forth axial movement. This means that the method of delivery according to the present disclosure can include a partial filling / expulsion step of the first fluid into / from each sub-chamber of the first chamber, especially when it is required that a defined (and typically small) volume of the first fluid is delivered in one shot (i.e. along one moving movement of the first plunger, without reversing it). Of course, this aspect described above can be applied to the sub-chambers 235', 236' of the second chamber 231' as well.

[0115] As mentioned above, during the step of delivering the first fluid (arrow F), the first supply station valve 211 remains open, thus allowing the new first fluid to enter either one of the two sub-chambers of the first chamber, without undesired perturbation effects occurring during the axial movement of the piston in said first chamber 231. It can be noted that the new first fluid entering the system during the step of delivering has not passed through the first actuator 270 and the first recirculation fluid circuit 260, but the new first fluid is not delivered instantly. In fact, the new first fluid enters the under-pressurized sub-chamber, while the first fluid delivered by the system is the fluid contained in the pressurized sub-chamber. Thus, before being delivered, the new first fluid is permanently moving and mixed in the respective sub-chamber thanks to the piston axial movement, thereby ensuring that the desired delivery conditions are reached before finally leaving the system.

[0116] As already mentioned above, the applicant has found that recirculating the first fluid in the first chamber 231 by making the first fluid flow through the first recirculation fluid circuit 260 and the first actuator 270 associated therewith can significantly reduce or even completely eliminate the risk of pressure pulsations when the first fluid is delivered, especially at the beginning of the fluid delivery procedure. Indeed, the fluid delivery system according to the present disclosure, thanks to the presence of the first recirculation fluid circuit 60 and the first actuator 270, can adequately control the pressure drops or pressure spikes that occur when the piston 232 starts to move. Indeed, according to the present disclosure, the fluid delivery system starts the delivery of the first fluid (outside the fluid delivery system - arrow F) when the recirculation of the first fluid inside the first chamber 231 has already started, so that the delivery starts when the piston is already moving in the first chamber 231. This clearly means that the start of the fluid delivery is not simultaneous with the piston starting to move. This is because delivery of the first fluid begins when the piston has already moved axially within the first chamber 231 to allow the recirculation step of the first fluid to take place.

[0117] Moreover, as already mentioned above, the applicant has also found that recirculating the first fluid in the first chamber 231 by making the first fluid flow through the first recirculation fluid circuit 260 and the first actuator 270 associated therewith can significantly reduce or even completely eliminate the delay time of the fluid delivery system. The delay time is the technical time that the fluid delivery system necessarily needs to prepare to deliver fluid. Indeed, as soon as the processor P issues an instruction to send a current to the drive unit M, said current typically creates an electromagnetic field that acts on the rotor magnet, which produces a torque on the gear, which causes the piston to start moving. Once the piston starts moving, a fluid pressure is created, which nevertheless requires some additional time to reach and overcome the pressure threshold set for the first and second outlet fluid circuit valves 255, 256. The sum of all these times is called the "delay time", which can never be ignored, and which necessarily causes a delay in the fluid delivery out of the fluid delivery system. Thanks to the presence of the first recirculation fluid circuit 260 and the associated first actuator 270, the fluid delivery system 200' of the present disclosure is able to overcome or reduce said delay time because the piston 232 starts moving well in advance of fluid delivery to effect recirculation of the first fluid in the first chamber 231. Thus, as soon as the processor P closes the first actuator 270 to initiate delivery of the first fluid (arrow F), the fluid pressure increases immediately and soon overcomes the pressure thresholds set for the first and second outlet fluid circuit valves 255, 256. As a result, the first fluid is delivered by the system shortly after the processor P commands delivery to commence.

[0118] As soon as it is requested to terminate the delivery of a first fluid (e.g., contrast agent) contained in the first supply station 210 and to start the delivery of a second fluid (e.g., saline solution) contained in the second supply station 210', the processor P opens the first actuator 270 of the first recirculation fluid circuit 260 and closes the second actuator 270' of the second recirculation fluid circuit 260', thus causing the delivery of the second fluid (arrow F') but recirculating the first fluid in the respective chambers 231.

[0119] Thus, the method of delivery according to the present disclosure further comprises a step of initiating the delivery of the second fluid contained in the first chamber 231' (i.e. outside the fluid delivery system). To carry out said step, as described above, the processor P closes the second actuator 270' of the second recirculation fluid circuit 260' and opens the second supply station valve 211'. During the delivery of the second fluid (fluid leaving the fluid delivery system - see arrow F'), the second supply station valve 211' is kept open, since it is important to refill the sub-chambers 235', 236' of the second chamber 231' with new second fluid in order to avoid fluid perturbations that could possibly affect the correct functioning of the piston and, consequently, the functioning of the entire fluid delivery system. Since closing the second actuator 270' prevents the second fluid from flowing through the second recirculation fluid circuit 260' (while, as already mentioned above, the first and second inlet fluid circuit valves 245', 247' do not allow any backflow of the second fluid into the second supply station 210'), pushing the second plunger 234' in a first direction (arrow G in FIG. 7) and in a second opposite direction (arrow H in FIG. 8) allows the second fluid to exit the second outlet port 254' and the first outlet port 253', respectively, of the second chamber 231'. Thus, when the second fluid is pushed through the second outlet port 254' (arrow G), the second fluid flows into the second outlet fluid pathway 252' of the second outlet fluid circuit 250' and through the second outlet fluid circuit valve 256'. Because, at this stage of the procedure, the second actuator 270' is closed, the fluid pressure is high enough to overcome the internal elasticity of the second outlet fluid circuit valve 256'. Similarly, when the second fluid is forced through the first outlet port 253' (arrow H), the second fluid flows into the first outlet fluid pathway 251' of the second outlet fluid circuit 250' and through the first outlet fluid circuit valve 255'. Because, at this stage of the procedure, the second actuator 270' is closed, the fluid pressure is high enough to overcome the internal elasticity of the first outlet fluid circuit valve 255'.As a result, the second fluid is finally delivered (arrow F') by sequentially discharging from the first and second sub-chambers 235', 236' of the second chamber 231'. Indeed, since the first and second outlet fluid circuit valves 255', 256' are one-way valves, the second fluid cannot flow back through the under-pressurized pathway and is therefore necessarily forced to be delivered (arrow F').

[0120] As mentioned above, the present disclosure relates to a modular fluid delivery system that includes at least one disposable pump module assembly. In particular, to better meet many different customer needs, a modular fluid delivery system according to the present disclosure may have one or more disposable pump module assemblies, each of which may have one or more fluid circuits as specified below in the present description.

[0121] 9 shows a perspective view of a first embodiment of a disposable pump module 500 of a modular fluid delivery system according to the present disclosure. The disposable pump module 500 comprises only one single fluid circuit pathway (described in more detail herein below), which represents the simplest pump module solution that can be used in a modular fluid delivery system of the present disclosure (such as that according to the fluid delivery system 100 shown diagrammatically in FIG. 1 and already disclosed in detail herein above). The disposable pump module 500 comprises a support element 510 comprising at least the following components: a chamber 520, an inlet fluid circuit pathway 540 entering said chamber, an outlet fluid circuit pathway 550 exiting said chamber, and a recirculation fluid circuit pathway 560 connecting two separate opposite branches of said inlet fluid circuit pathway 540. Typically, the support element 510 is obtained by associating together (for example by UV gluing, heat gluing, solvent bonding, US welding, laser welding, spin welding) two separate layers, each of which is provided with a recess of suitable size that forms said component when the two layers are integrally engaged together. The component so formed is thus consequently completely embedded within the thickness of the support element. Preferably, said layer is a molded plastic layer.

[0122] For further clarification, the two separate layers are not fully visible in Figure 9, but are clearly shown, for example, in Figure 13. Indeed, Figure 9 shows a disposable pump module where some transparency indicates the presence of a second, bottom layer disposed below the first layer (which is clearly visible at the foreground).

[0123] The inlet fluid circuit pathway 540 is in fluid communication with a fluid supply station (not shown in FIG. 9) and with the chamber 520. In particular, the inlet fluid circuit pathway 540 comprises a first inlet pathway 541, which successively branches into a second inlet pathway 542 and a third inlet pathway 543, which are in fluid communication with the first sub-chamber 521 and the second sub-chamber 522 of the chamber 520, respectively. Indeed, the disposable pump module 500 further comprises a piston 525 that is reciprocated in the chamber 520 (i.e. moved back and forth by a drive unit M (not shown in FIG. 9)). The piston 525 comprises a piston rod 526 and a plunger 527, the plunger being arranged substantially perpendicular to the piston rod and having a radial extension substantially corresponding to the chamber width. Thus, in cooperation with the inner walls of chamber 520, plunger 527 defines a first variable volume sub-chamber 521 on one side of the plunger (e.g., the left side of the plunger in the embodiment of FIG. 9) and a second variable volume sub-chamber 522 on the opposite side of the plunger (e.g., the right side of the plunger in the embodiment of FIG. 9).

[0124] The first inlet pathway 541 further comprises a first seat 544 for receiving a supply station valve (not shown in FIG. 9) that allows fluid to be appropriately discharged from the supply station. The supply station valve is an active valve that is directly operated by the processor P of the fluid delivery system, for example as previously described with respect to FIG.

[0125] Preferably, the supply station valve is not part of the disposable pump module 500; typically, it is a component that the modular fluid delivery system has. For example, if the modular fluid delivery system is a powered injector suitable for use in the medical field, the supply station valve is typically received within the injector head.

[0126] Alternatively, the supply station valve is part of the disposable pump module 500 and is received within the first seat 544 of the support element 510 .

[0127] Typically, the first inlet pathway 541 further comprises a second seat 545 for receiving an air bubble detector (not shown in FIG. 9 ) included in the modular fluid delivery system (and thus not part of the disposable pump module 500) used to detect the presence of air bubbles possibly contained in the fluid discharged from the supply station. The air bubble detector can be of any type known in the art, for example an ultrasonic or capacitive sensor.

[0128] The first inlet pathway 541 further comprises a third seat 546 for receiving, if necessary, a filtration unit (not shown in FIG. 9) that can be used to ensure the absence of impurities or any further substances that should not be included in the delivered fluid(s). The filtration unit is an optional component, the presence of which depends on the nature / characteristics of the fluid(s).

[0129] Downstream of the third sheet 546, the first inlet pathway 541 branches into a second inlet pathway 542 and a third inlet pathway 543, which are in fluid communication with the first sub-chamber 521 and the second sub-chamber 522, respectively. The first sub-chamber 521 includes a first inlet port 523, thereby allowing the second inlet pathway 542 to be in fluid communication with the first sub-chamber 521. Similarly, the second sub-chamber 522 includes a second inlet port 524, thereby allowing the third inlet pathway 543 to be in fluid communication with the second sub-chamber 522.

[0130] Upstream of the first inlet port 523, the second inlet pathway 542 includes a seat 547 for receiving a first inlet fluid circuit valve (not shown in FIG. 9 ) that allows fluid to flow through the second inlet pathway 542 and into the first sub-chamber 521. According to one embodiment of the present disclosure, the first inlet fluid circuit valve is a check valve, i.e., a one-way valve that allows fluid to flow only in one direction (specifically, from the supply station towards the first sub-chamber 521), thereby preventing fluid from flowing back into the supply station.

[0131] Similarly, upstream of the second inlet port 524, the third inlet pathway 543 includes a seat 548 for receiving a second inlet fluid circuit valve (not shown in FIG. 9 ) that allows fluid to flow through the third inlet pathway 543 and into the second sub-chamber 522. According to one embodiment of the present disclosure, the second inlet fluid circuit valve is a check valve, i.e., a one-way valve that allows fluid to flow in only one direction (specifically, from the supply station towards the second sub-chamber 522) without backflow, thereby avoiding fluid backflow into the supply station.

[0132] Preferably, the first and second inlet fluid circuit valves are ball check valves, with a ball inside the body valve to control fluid flow.

[0133] As mentioned above, the disposable pump module 500 further comprises an outlet fluid circuit pathway 550 separate from the inlet fluid circuit pathway 540. The outlet fluid circuit pathway 550 is in fluid communication with the chamber 520 and comprises a first outlet pathway 551 and a second outlet pathway 552 for discharging fluid from the chamber 520. In particular, the first sub-chamber 521 comprises a first outlet port 553, thereby allowing the first outlet pathway 551 to be in fluid communication with the first sub-chamber 521. Similarly, the second sub-chamber 522 comprises a second outlet port 554, thereby allowing the second outlet pathway 552 to be in fluid communication with the second sub-chamber 522. As already mentioned above with respect to FIG. 1, in operation, the first and second outlet pathways 551, 552 of the outlet fluid circuit pathway 550 discharge fluid from either the first sub-chamber 521 or the second sub-chamber 522.

[0134] Downstream of the first outlet port 553, the first outlet pathway 551 comprises a seat 555 for receiving a first outlet fluid circuit valve (not shown in FIG. 9 ) that allows fluid to be discharged from the first sub-chamber 521 through the first outlet pathway 551. According to one embodiment of the present disclosure, the first outlet fluid circuit valve is a check valve, i.e. a one-way valve that allows fluid to flow in only one direction (specifically out of the first sub-chamber 521) without backflow, thereby avoiding fluid from flowing back into said first sub-chamber 521.

[0135] Similarly, downstream of the second outlet port 554, the second outlet pathway 552 includes a seat 556 for receiving a second outlet fluid circuit valve (not shown in FIG. 9 ) that allows fluid to be discharged from the second sub-chamber 522 through the second outlet pathway 552. According to one embodiment of the present disclosure, the second outlet fluid circuit valve is a check valve, i.e., a one-way valve that allows fluid to flow in only one direction (specifically, out of the second sub-chamber 522), thereby preventing fluid from flowing back into said second sub-chamber 522.

[0136] Preferably, the first and second outlet fluid circuit valves are spring loaded check valves, where a spring component is used to assist in valve operation by eliminating the effect of gravity on the check valve function, and more preferably, the first and second outlet fluid circuit valves are spring loaded ball check valves.

[0137] In accordance with the present disclosure, the disposable pump module 500 further comprises a recirculation fluid circuit pathway 560 fluidly connecting the first and second variable volume subchambers 521, 522, the recirculation fluid circuit 560 cooperating with an actuator (not shown in FIG. 9 ) for governing the passage of fluid in both directions between the first and second variable volume subchambers 521, 522.

[0138] According to the embodiment shown in Fig. 9, the recirculation fluid circuit pathway 560 is external to the chamber 520 and fluidly connects the separate branches 542, 543 of the inlet fluid circuit pathway 540 upstream of the first and second inlet ports 523, 524 of the sub-chambers 521, 522. In particular, a first axial end 561 of the recirculation fluid circuit pathway 560 connects the second inlet pathway 542 of the inlet fluid circuit pathway 540 downstream of the seat 547 of the first inlet fluid circuit valve. Similarly, a second axial end 562 of the recirculation fluid circuit pathway 560 connects the third inlet pathway 543 of the inlet fluid circuit pathway 540 downstream of the seat 548 of the second inlet fluid circuit valve.

[0139] The recirculation fluid circuit pathway 560 further comprises a seat 563 suitable for receiving an actuator (not shown in FIG. 9), which is typically an active valve operated by a modular fluid delivery system, e.g. as already explained above with reference to the embodiment shown in FIG. 1. Preferably, said actuator is an electromechanically actuated valve automatically controlled and operated by a processor of the modular fluid delivery system (processor P in FIG. 1). As shown diagrammatically in the figure, processor P controls and operates said actuator, drive unit M and supply station valves.

[0140] According to one embodiment of the present disclosure, the actuator is not part of the disposable pump module 500, which merely comprises a seat 563 for receiving an actuator, which is preferably a component of the modular fluid delivery system. For example, if the modular fluid delivery system is a powered injector suitable for use in the medical field, the actuator of the recirculation fluid circuit pathway 560 would typically be located in the injector head.

[0141] Alternatively, the actuator is part of the disposable pump module 500 and it is received in its seat 563 formed in the support element 510 .

[0142] Figure 10 illustrates a perspective view of a disposable pump module assembly 700 according to one embodiment of the present disclosure. In particular, Figure 10 illustrates the disposable pump module 500 of Figure 9 in combination with fluid circuit tubing 600 suitable for connecting to a fluid supply reservoir (not shown), conveying said fluid along various pathways of the disposable pump module (described above with respect to Figure 9), and ultimately expelling said fluid outside the disposable pump module at a pre-determined pressurized state (i.e., a desired pressure and flow rate value).

[0143] The disposable pump module 500 of FIG. 9 and the disposable pump module assembly 700 of FIG. 10 are designed and configured to receive and expel only one type of fluid.

[0144] The fluid circuit tubes 600 include an inlet fluid circuit tube 610 (whose branches are received in corresponding first, second and third inlet pathways 541, 542, 543, respectively), an outlet fluid circuit tube 620 (whose branches are received in first and second outlet pathways 551, 552), and a recirculation fluid circuit tube 630 (received in recirculation fluid circuit pathway 560).

[0145] According to a first embodiment, the inlet fluid circuit tube 610 comprises two distal ends and one proximal end, in particular the two distal ends connect with the first inlet port 523 of the first sub-chamber 521 and the second inlet port 524 of the second sub-chamber 522, respectively, while the proximal end comprises a connector (not shown in FIG. 10) for fluidly engaging a fluid supply station (not shown in FIG. 10).

[0146] Moreover, the outlet fluid circuit tube 620 comprises two proximal ends and one distal end. In particular, the two proximal ends connect to the first outlet port 553 of the first sub-chamber 521 and the second outlet port 554 of the second sub-chamber 522, respectively, while the distal end typically comprises a connector (not shown in FIG. 10) for discharging the pressurized fluid exiting the disposable pump module assembly. When the disposable pump module assembly is applied in the medical field (e.g., for injecting a certain substance (e.g., contrast agent, medicine, drug) into the vascular system or organs of a patient), typically, the connector at said distal end is fluidly engaged with an additional tube (generally indicated as a patient line), thereby ensuring that the disposable pump module assembly is not cross-contaminated when a new patient is connected to the disposable pump module assembly already used for a previous patient. In practice, the additional tube is discarded after each single use, while the disposable pump module assembly is maintained in operation for a predetermined number of patients and / or for a predetermined period of time, as described above.

[0147] Alternatively, the proximal end of the inlet fluid circuit tube 610 terminates flush with the proximal port 549 of the inlet fluid circuit pathway 540, such that a connector is directly associated with said proximal port 549 for fluidly connecting to the fluid supply station.

[0148] According to a second embodiment (shown in FIG. 10), the fluid circuit tube 600 does not have to be a continuous tube or a branch of an unbroken continuous tube that is received along the entire longitudinal extension of the inlet, outlet and recirculation fluid circuit pathway. In fact, the main part of the fluid circuit pathway (created when making the support element 510, for example by associating together two molded parts that form said support element) already defines a conduit suitable for carrying the fluid during its flow along within the disposable pump module. Thus, according to said second embodiment, the fluid circuit tube 600 comprises only a few very short tube sections that are mainly provided at the sensing locations of the disposable pump module, which are the locations where detection of a specific property of the fluid should occur or where a specific action is required to be exerted on the fluid flow. For example, the tube segment is typically required to be in correspondence with a first seat 544, which is the location where a supply station valve (not shown in FIGS. 9 and 10) is operated to act on (e.g., clamp) the tube segment to control whether or not fluid enters the disposable pump module. As a further example, the tube segment is typically required to be in correspondence with a second seat 545, which is the location where an air bubble detector (not shown in FIGS. 9 and 10) is operated to identify the presence, number, and / or size of air bubbles contained within the flowing fluid. As a further example, the tube segment is typically required to be in correspondence with a seat 563, which is the location where an actuator (not shown in FIGS. 9 and 10) is operated to act on (e.g., clamp) the tube segment to control whether or not fluid passes through the recirculation fluid circuit pathway 560.

[0149] It can be understood that some technical solutions can be used to interrupt the fluid flow, to alternately block and open the fluid flow, or to perform certain measurements on the flowing fluid (such as detecting air bubbles). It is therefore clear that, based on the technical solution chosen to be implemented, in certain parts of the fluid circuit tube 600, tube sections can be omitted or are absolutely strictly necessary. For example, if an electromagnetic closure or a rotary valve (which can be operated by a processor that the fluid delivery system has) is placed in (i.e. inside) the fluid circuit pathway, the latter can be appropriately used as a conduit for the fluid to flow. Thus, in this case, the conduit made when the fluid circuit pathway is formed (i.e. the fluid track created when two separate layers are assembled together) is sufficient to adequately guide and block the fluid flow without the need to provide additional tube sections.

[0150] Figure 10 also shows an extension 528 of the piston rod 526 which engages a suitable gear 529 (not shown in detail) for connecting the piston 525 to a drive unit M (not shown in Figure 10). Preferably, the gear 529 is not part of the disposable pump module assembly 700 but is included within the modular fluid delivery system (and thus is part of the injector head if the latter is an injector for use in the medical field).

[0151] 16, a modular fluid delivery system according to an embodiment of the present disclosure includes at least one disposable pump module assembly 700. For example, if two separate fluids are required to be delivered appropriately, a modular fluid delivery system according to an embodiment of the present disclosure may include a first disposable pump module assembly 700 for delivering a first fluid and a second disposable pump module assembly 700 for delivering a second fluid, the second fluid being different from the first fluid.

[0152] According to one embodiment of the modular fluid delivery system of the present disclosure, a first disposable pump module assembly 700 for delivering a first fluid and a second disposable pump module assembly 700 for delivering a second fluid are arranged in series, and the first and second pump module assemblies are connected to a common drive unit M of the modular fluid delivery system (such as the fluid delivery system 200' shown in FIG. 6).

[0153] According to an alternative embodiment of the modular fluid delivery system of the present disclosure, a first disposable pump module assembly 700 for delivering a first fluid and a second disposable pump module assembly 700 for delivering a second fluid are arranged in parallel with each other. According to one embodiment of the parallel arrangement, the first and second pump module assemblies are connected to a common drive unit M of a modular fluid delivery system (such as the fluid delivery system 200 shown in FIG. 5). According to an alternative embodiment of the parallel arrangement, the first pump module assembly is connected to a first drive unit of the modular fluid delivery system and the second pump module assembly is connected to a second drive unit of the modular fluid delivery system, the first and second drive units being separate and distinct drive units.

[0154] According to a further alternative embodiment of the present disclosure, a modular fluid delivery system for delivering a first fluid (contained in a first reservoir or first supply station) and a second fluid (contained in a second reservoir or second supply station), said first fluid and said second fluid being different from each other, comprises a single disposable pump module assembly including two separate fluid circuits X, Y arranged in series as shown in Figures 11 and 12, said single disposable pump module assembly designed to complete, for example, fluid delivery system 200' of Figure 6.

[0155] In particular, Figure 11 illustrates a perspective view of one embodiment of a disposable pump module 800 of a modular fluid delivery system according to the present disclosure. The disposable pump module 800 comprises two separate fluid circuits X, Y (shown in Figure 12) for managing and pressurizing two separate fluids, i.e., a first fluid is provided to the first fluid circuit X and a second fluid is provided to the second fluid circuit Y. Similar to the disposable pump module 500 of FIG. 9, the disposable pump module 800 comprises a support element 810 comprising, for each fluid circuit X, Y, at least the following components: chambers 820, 820′ (a first chamber 820 associated with the first fluid circuit X and a second chamber 820′ associated with the second fluid circuit Y), inlet fluid circuit pathways 840, 840′ entering said chambers (a first inlet fluid circuit pathway 840 associated with the first fluid circuit X and entering the first chamber 820, and a second inlet fluid circuit pathway 840′ associated with the second fluid circuit Y and entering the second chamber 820′); outlet fluid circuit pathways 850, 850' (a first outlet fluid circuit pathway 850 is associated with a first fluid circuit X and exits the first chamber 820, and a second outlet fluid circuit pathway 850' is associated with a second fluid circuit Y and exits the second chamber 820'), and recirculation fluid circuit pathways 860, 860' (a first recirculation fluid circuit pathway 860 is associated with a first fluid circuit X and connects two separate, opposite branches of the first inlet fluid circuit pathway 840, and a second recirculation fluid circuit pathway 860' is associated with a second fluid circuit Y and connects two separate, opposite branches of the second inlet fluid circuit pathway 840').

[0156] Typically, the support element 810 is obtained by associating together two separate layers (not visible in FIG. 11 but clearly shown for example in FIG. 13), each layer provided with a recess of suitable size, thereby forming the above-mentioned components of the two fluid circuits X, Y when the two layers are integrally engaged together, said formed components thus being embedded in the thickness of the support element. Preferably, said layers are moulded plastic layers.

[0157] The inlet fluid circuit pathways 840, 840' are in fluid communication with corresponding fluid supply stations (not shown in FIG. 11) and respective chambers 820, 820'.

[0158] Concerning the first fluid circuit X, in detail, the first inlet fluid circuit pathway 840 comprises a first inlet pathway 841 which successively branches into a second inlet pathway 842 and a third inlet pathway 843 which are in fluid communication with the first variable volume sub-chamber 821 and the second variable volume sub-chamber 822 of the first chamber 820, respectively. Indeed, the disposable pump module 800 further comprises a piston 825 which is reciprocated (i.e. moved back and forth by the drive unit M) in the first chamber 820. The piston 825 comprises a piston rod 826 and a first plunger 827, the plunger being arranged substantially perpendicular to the piston rod and having a radial extension substantially corresponding to the first chamber width. Thus, in cooperation with the inner wall of the first chamber 820, the first plunger 827 defines a first sub-chamber 821 on one side of the plunger (the left side of the first plunger in the embodiment of FIG. 11) and a second sub-chamber 822 on the opposite side of the plunger (the right side of the first plunger in the embodiment of FIG. 11).

[0159] The first inlet pathway 841 further comprises a first seat 844 for receiving a supply station valve 870 (shown in FIG. 11 for a better understanding of its placement and interaction with the disposable pump module 800) that allows the first fluid to be properly discharged from the first supply station. The supply station valve is an active valve that is directly operated by the fluid delivery system, as previously described with respect to FIG.

[0160] Preferably, the supply station valves are not part of the disposable pump module 800, but are typically components of a modular fluid delivery system. For example, if the modular fluid delivery system is a powered injector suitable for use in the medical field, the supply station valves are typically received within the injector head.

[0161] Alternatively, the supply station valve 870 is part of the disposable pump module 800 and is received within the first seat 844 of the support element 810 .

[0162] In some applications, the first inlet pathway 841 further comprises a second seat 845 for receiving an air bubble detector 880 (shown in FIG. 11 for a better understanding of its placement and interaction with the disposable pump module 800), which is included with the modular fluid delivery system (and thus is not part of the disposable pump module 800) and is used to detect the presence of air bubbles optionally contained within the first fluid released from the first supply station. The air bubble detector can be of any type known in the art, for example an ultrasonic or capacitive sensor.

[0163] The first inlet pathway 841 further comprises a third seat 846 for receiving a filtration unit (not shown in FIG. 11 ), which can be used, if necessary, to ensure the absence of impurities or any further substances that should not be included in the delivered fluid(s). The filtration unit is an optional component, the presence of which depends on the nature / characteristics of the fluid(s).

[0164] Downstream of the third sheet 846, the first inlet pathway 841 branches into a second inlet pathway 842 and a third inlet pathway 843 that are in fluid communication with the first sub-chamber 821 and the second sub-chamber 822, respectively. The first sub-chamber 821 includes a first inlet port 823, thereby allowing the second inlet pathway 842 to be in fluid communication with the first sub-chamber 821. Similarly, the second sub-chamber 822 includes a second inlet port 824, thereby allowing the third inlet pathway 843 to be in fluid communication with the second sub-chamber 822.

[0165] Upstream of the first inlet port 823, the second inlet pathway 842 includes a seat 847 for receiving a first inlet fluid circuit valve (not shown in FIG. 11 ) that allows the first fluid to flow through the second inlet pathway 842 and into the first sub-chamber 821. According to one embodiment of the present disclosure, the first inlet fluid circuit valve is a check valve, i.e., a one-way valve that allows fluid to flow only in one direction (specifically, from the first supply station towards the first sub-chamber 821), thereby preventing the first fluid from flowing back into the first supply station.

[0166] Similarly, upstream of the second inlet port 824, the third inlet pathway 843 includes a seat 848 for receiving a second inlet fluid circuit valve (not shown in FIG. 11 ) that allows the first fluid to flow through the third inlet pathway 843 and into the second sub-chamber 822. According to one embodiment of the present disclosure, the second inlet fluid circuit valve is a check valve, i.e., a one-way valve that allows the first fluid to flow in only one direction (specifically, from the first supply station towards the second sub-chamber 822) without backflow, thereby avoiding backflow of the first fluid into the first supply station.

[0167] Preferably, the first and second inlet fluid circuit valves are ball check valves, with a ball inside the body valve to control fluid flow.

[0168] As described above, the disposable pump module 800 further comprises an outlet fluid circuit pathway 850 separate from the inlet fluid circuit pathway 840. The outlet fluid circuit pathway 850 is in fluid communication with the chamber 820 and comprises a first outlet pathway 851 and a second outlet pathway 852 for discharging the first fluid from the chamber 820. In particular, the first sub-chamber 821 comprises a first outlet port 853, thereby allowing the first outlet pathway 851 to be in fluid communication with the first sub-chamber 821. Similarly, the second sub-chamber 822 comprises a second outlet port 854, thereby allowing the second outlet pathway 852 to be in fluid communication with the second sub-chamber 822. As already described above with respect to FIG. 6, in operation, the first and second outlet pathways 851, 852 of the outlet fluid circuit pathway 850 discharge the first fluid from either the first sub-chamber 821 or the second sub-chamber 822.

[0169] Downstream of the first outlet port 853, the first outlet pathway 851 comprises a seat 855 for receiving a first outlet fluid circuit valve (not shown in FIG. 11 ) that allows the first fluid to be discharged from the first sub-chamber 821 through the first outlet pathway 851. According to one embodiment of the present disclosure, the first outlet fluid circuit valve is a check valve, i.e. a one-way valve that allows the first fluid to flow only in one direction (specifically out of the first sub-chamber 821) without backflow, thereby avoiding backflow of the first fluid into said first sub-chamber 821.

[0170] Similarly, downstream of the second outlet port 854, the second outlet pathway 852 includes a seat 856 for receiving a second outlet fluid circuit valve (not shown in FIG. 11 ) that allows the first fluid to be discharged from the second sub-chamber 822 through the second outlet pathway 852. According to one embodiment of the present disclosure, the second outlet fluid circuit valve is a check valve, i.e., a one-way valve that allows the first fluid to flow only in one direction (specifically, out of the second sub-chamber 822), thereby avoiding the first fluid from flowing back into said second sub-chamber 822.

[0171] Preferably, the first and second outlet fluid circuit valves are spring loaded check valves, where a spring component is used to assist in valve operation by eliminating the effect of gravity on the check valve function, and more preferably, the first and second outlet fluid circuit valves are spring loaded ball check valves.

[0172] In accordance with the present disclosure, the disposable pump module 800 further comprises a recirculation fluid circuit pathway 860 fluidly connecting said first and second variable volume subchambers 821, 822, said recirculation fluid circuit 860 cooperating with an actuator 890 (shown in FIG. 11 for a better understanding of its placement and interaction with the disposable pump module 800) for governing the passage of fluid in both directions between said first and second variable volume subchambers 821, 822.

[0173] According to the embodiment shown in Fig. 11, the recirculation fluid circuit pathway 860 is external to the chamber 820 and fluidly connects the separate branches 842, 843 of the inlet fluid circuit pathway 840 upstream of the first and second inlet ports 823, 824 of the sub-chambers 821, 822. In particular, a first axial end 861 of the recirculation fluid circuit pathway 860 connects the second inlet pathway 842 of the inlet fluid circuit pathway 840 downstream of the seat 847 of the first inlet fluid circuit valve. Similarly, a second axial end 862 of the recirculation fluid circuit pathway 860 connects the third inlet pathway 843 of the inlet fluid circuit pathway 840 downstream of the seat 848 of the second inlet fluid circuit valve.

[0174] The recirculation fluid circuit pathway 860 further comprises a seat 863 suitable for receiving said actuator 890, which is typically an active valve operated by the modular fluid delivery system as already explained above with respect to the embodiment shown in Figure 6. Preferably, said actuator is an electromechanically actuated valve automatically controlled and operated by a processor (processor P in Figure 6) of the modular fluid delivery system. As shown diagrammatically in the figure, processor P controls and operates said actuator, drive unit M and supply station valves.

[0175] According to one embodiment of the present disclosure, the actuator 890 is not part of the disposable pump module 800, which merely includes a seat 863 for receiving an actuator, which is preferably a component of the modular fluid delivery system. For example, if the modular fluid delivery system is a powered injector suitable for use in the medical field, the actuator of the recirculation fluid circuit pathway 860 would typically be located in the injector head.

[0176] Alternatively, the actuator 890 is part of the disposable pump module 800 and is received within its seat 863 formed within the support element 810 .

[0177] Concerning the second fluid circuit Y, in particular the second inlet fluid circuit pathway 840' comprises a first inlet pathway 841' which successively branches into a second inlet pathway 842' and a third inlet pathway 843' which are in fluid communication with the first sub-chamber 821' and the second sub-chamber 822' of the second chamber 820', respectively. In fact, the piston 825 is reciprocated (i.e. moved back and forth by the drive unit M) not only in the first chamber 820 but also in the second chamber 820', said first and second chambers being aligned in series. The piston rod 826 comprises a second plunger 827' which is arranged substantially perpendicular to the piston rod and has a radial extension which substantially corresponds to the second chamber width. Thus, in cooperation with the inner wall of the second chamber 820', the second plunger 827' defines a first sub-chamber 821' on one side of the plunger (the left side of the second plunger in the embodiment of FIG. 11) and a second sub-chamber 822' on the opposite side of the plunger (the right side of the second plunger in the embodiment of FIG. 11).

[0178] According to the embodiment shown in FIG. 11, the first inlet pathway 841′ comprises two opposing separate branches 841′a, 841′b that convey the second inlet pathway 842′ and the third inlet pathway 843′ upstream to a common branch 841′c. Each branch 841′a, 841′b comprises a first seat 844′ for receiving a corresponding supply station valve 870′ (supply station valves 870′ are shown in FIG. 11 for a better understanding of their arrangement and interaction with the disposable pump module 800), which allows the second fluid to be appropriately discharged from two separate second supply stations (not shown in FIG. 11). The supply station valves are active valves that are directly operated by the fluid delivery system, as previously described with respect to FIG. 6.

[0179] In some applications, the common branch 841'c of the first inlet pathway 841' further includes a second seat 845' for receiving an air bubble detector 880' (shown in FIG. 11 for a better understanding of its placement and interaction with the disposable pump module 800), which is included in the modular fluid delivery system (and thus is not part of the disposable pump module 800) and which is used to detect the presence of air bubbles that may be contained in the second fluid released from the second supply station.

[0180] The first inlet pathway 841' further comprises a third seat 846' for receiving a filtration unit (not shown in FIG. 11).

[0181] Downstream of the third sheet 846', the first inlet pathway 841' branches into a second inlet pathway 842' and a third inlet pathway 843' in fluid communication with the first sub-chamber 821' and the second sub-chamber 822', respectively. The first sub-chamber 821' includes a first inlet port 823', thereby allowing the second inlet pathway 842' to be in fluid communication with the first sub-chamber 821'. Similarly, the second sub-chamber 822' includes a second inlet port 824', thereby allowing the third inlet pathway 843' to be in fluid communication with the second sub-chamber 822'.

[0182] Upstream of the first inlet port 823', the second inlet pathway 842' includes a seat 847' for receiving a first inlet fluid circuit valve (not shown in FIG. 11 ) that allows the second fluid to flow through the second inlet pathway 842' into the first sub-chamber 821'. According to one embodiment of the present disclosure, the first inlet fluid circuit valve is a check valve, i.e., a one-way valve that allows fluid to flow only in one direction (specifically, from a selected and actuated second supply station toward the first sub-chamber 821'), thereby avoiding backflow of the second fluid into the actuated second supply station.

[0183] Similarly, upstream of the second inlet port 824', the third inlet pathway 843' includes a seat 848' for receiving a second inlet fluid circuit valve (not shown in FIG. 11 ) that allows the second fluid to flow through the third inlet pathway 843' into the second sub-chamber 822'. According to one embodiment of the present disclosure, the second inlet fluid circuit valve is a check valve, i.e., a one-way valve that allows the second fluid to flow only in one direction (specifically, from a selected and actuated second supply station toward the second sub-chamber 822') without backflow, thereby avoiding backflow of the second fluid into the actuated second supply station.

[0184] Preferably, the first and second inlet fluid circuit valves are ball check valves, with a ball inside the body valve to control fluid flow.

[0185] As described above, the disposable pump module 800 further comprises an outlet fluid circuit pathway 850' separate from the inlet fluid circuit pathway 840'. The outlet fluid circuit pathway 850' is in fluid communication with the chamber 820' and comprises a first outlet pathway 851' and a second outlet pathway 852' for discharging the second fluid from the chamber 820'. In particular, the first sub-chamber 821' comprises a first outlet port 853', thereby allowing the first outlet pathway 851' to be in fluid communication with the first sub-chamber 821'. Similarly, the second sub-chamber 822' comprises a second outlet port 854', thereby allowing the second outlet pathway 852' to be in fluid communication with the second sub-chamber 822'. As already described above with respect to FIG. 6, in operation the first and second outlet pathways 851', 852' of the outlet fluid circuit pathway 850' discharge the second fluid from either the first sub-chamber 821' or the second sub-chamber 822'.

[0186] Downstream of the first outlet port 853', the first outlet pathway 851' comprises a seat 855' for receiving a first outlet fluid circuit valve (not shown in FIG. 11 ) that allows the second fluid to be discharged from the first sub-chamber 821' through the first outlet pathway 851'. According to one embodiment of the present disclosure, the first outlet fluid circuit valve is a check valve, i.e. a one-way valve that allows the second fluid to flow only in one direction (specifically out of the first sub-chamber 821') without backflow, thereby avoiding the second fluid from flowing back into said first sub-chamber 821'.

[0187] Similarly, downstream of the second outlet port 854', the second outlet pathway 852' includes a seat 856' for receiving a second outlet fluid circuit valve (not shown in FIG. 11 ) that allows the second fluid to be discharged from the second sub-chamber 822' through the second outlet pathway 852'. According to one embodiment of the present disclosure, the second outlet fluid circuit valve is a check valve, i.e., a one-way valve that allows the second fluid to flow only in one direction (specifically, out of the second sub-chamber 822'), thereby preventing the second fluid from flowing back into said second sub-chamber 822'.

[0188] In accordance with the present disclosure, the disposable pump module 800 further comprises a recirculation fluid circuit pathway 860' fluidly connecting said first and second variable volume subchambers 821', 822', said recirculation fluid circuit 860' cooperating with an actuator 890' (shown in FIG. 11 for a better understanding of its placement and interaction with the disposable pump module 800) for governing the passage of fluid in both directions between said first and second variable volume subchambers 821', 822'.

[0189] According to the embodiment shown in FIG. 11, the recirculation fluid circuit pathway 860' is external to the chamber 820' and fluidly connects the separate branches 842', 843' of the inlet fluid circuit pathway 840' upstream of the first and second inlet ports 823', 824' of the sub-chambers 821', 822'. In particular, a first axial end 861' of the recirculation fluid circuit pathway 860' connects the second inlet pathway 842' of the inlet fluid circuit pathway 840' downstream of the seat 847' of the first inlet fluid circuit valve. Similarly, a second axial end 862' of the recirculation fluid circuit pathway 860' connects the third inlet pathway 843' of the inlet fluid circuit pathway 840' downstream of the seat 848' of the second inlet fluid circuit valve.

[0190] The recirculation fluid circuit pathway 860' further comprises a seat 863' suitable for receiving said actuator 890', which is typically an active valve operated by the modular fluid delivery system as already described above with respect to the embodiment shown in Figure 6. Preferably, said actuator is an electromechanically actuated valve automatically controlled and operated by a processor (processor P in Figure 6) of the modular fluid delivery system. As shown diagrammatically in the figure, processor P controls and operates said actuator, drive unit M and supply station valves.

[0191] According to one embodiment of the present disclosure, the actuator 890' is not part of the disposable pump module 800, which merely includes a seat 863' for receiving an actuator, which is preferably a component of the modular fluid delivery system. For example, if the modular fluid delivery system is a power injector suitable for use in the medical field, the actuator of the recirculation fluid circuit pathway 860' is typically located in the injector head.

[0192] Alternatively, the actuator 890' is part of the disposable pump module 800 and is received within its seat 863' formed in the support element 810'.

[0193] According to the embodiment of the present disclosure shown in FIG. 11, the first and second outlet fluid circuit pathways 850, 850' ultimately convey into a common outlet pathway 857 that defines suitable tracks to enable the first and second fluids to exit the disposable pump module 800.

[0194] Along its longitudinal extension, the common outlet pathway 857 includes a seat 858 for receiving an additional air bubble detector 880 (shown in FIG. 11 for a better understanding of its placement and interaction with the disposable pump module 800), which is manipulated to perform a final check on the fluid flow at the outlet of the disposable pump module 800.

[0195] Downstream of the seat 858, the common outlet pathway 857 further comprises a seat 859 for receiving at least one pressure sensor (not shown in FIG. 11 ) for properly checking the accuracy of the pressure values ​​of the two (first and second) pressurized fluids alternately and sequentially exiting the disposable pump module 800. It may be noted that in the embodiment of FIG. 11 , the seat 859 is designed to receive two extra pressure sensors, said pressure sensors being duplicated for safety reasons.

[0196] It may be emphasized that the at least one pressure sensor is also envisioned in modular fluid delivery systems in which one or more disposable pump module assemblies with a single fluid circuit (such as disposable pump module assembly 700 of FIG. 10) are envisioned. In this case (such as modular fluid delivery system 5000 of FIG. 17 detailed in the description below), the at least one pressure sensor is not received within the or each single disposable pump module assembly, but is located inside the modular fluid delivery system (e.g., in an injector head if the modular fluid delivery system is an injector used in the medical field).

[0197] Figure 12 shows a perspective view of a disposable pump module assembly 1000 according to one embodiment of the present disclosure. In particular, Figure 12 shows the disposable pump module 800 of Figure 11 in combination with a fluid circuit tube 900 suitable for connecting to first and second fluid supply stations (not shown in Figure 12), for conveying said first and second fluids along several pathways (as described above with respect to Figure 11) that the disposable pump module has, and finally for expelling said first and second fluids outside the disposable pump module at a predetermined pressure condition (i.e., desired pressure and flow rate values).

[0198] The disposable pump module 800 of FIG. 11 and the disposable pump module assembly 1000 of FIG. 12 are designed and configured to receive and eject two different types of fluids, a first fluid and a second fluid, the second fluid being different from the first fluid, the first fluid being received in a first fluid circuit X (shown in FIG. 12) and the second fluid being received in a second fluid circuit Y (shown in FIG. 12).

[0199] With respect to the first fluid circuit X, and similar to the embodiment already described in relation to FIG. 10, the fluid circuit tubes 900 comprise a first inlet fluid circuit tube 910 (whose branches are received in corresponding first, second and third inlet pathways 841, 842, 843), a first outlet fluid circuit tube 920 (whose branches are received in first and second outlet pathways 851, 852) and a first recirculation fluid circuit tube 930 (received in recirculation fluid circuit pathway 860).

[0200] According to a first embodiment, the first inlet fluid circuit tube 910 comprises two distal ends and one proximal end, in particular the two distal ends connect to the first inlet port 823 of the first sub-chamber 821 and the second inlet port 824 of the second sub-chamber 822, respectively, while the proximal end comprises a first connector 940 for fluidly engaging a fluid supply reservoir or fluid supply station (not shown) of the first fluid.

[0201] Furthermore, the first outlet fluid circuit tube 920 comprises two proximal ends and one distal end, in particular the two proximal ends connect to the first outlet port 853 of the first sub-chamber 821 and the second outlet port 854 of the second sub-chamber 822, respectively, while the distal end conveys into a common outlet tube 950.

[0202] With respect to the second fluid circuit Y, the fluid circuit tubes 900 include a second inlet fluid circuit tube 910', a second outlet fluid circuit tube 920' and a second recirculation fluid circuit tube 930'.

[0203] In particular, the second inlet fluid circuit tube 910' comprises two inlet tubes 910'a, 910'b which convey to a common intermediate inlet tube 910'c which finally branches again into two separate final inlet tubes 910'd, 910'e. Each inlet tube 910'a, 910'b is provided with a suitable connector 940' for fluidly engaging the second inlet fluid circuit tube 910' with two separate supply stations of a second fluid required to flow within the second fluid circuit Y. The second inlet fluid circuit tube 910' comprises two separate inlet tubes 910'a, 910'b, so that two reservoirs of the same second fluid are always available in case the operated reservoir is approaching an empty state and a quick switch to a new filled reservoir is required to ensure a continuous supply of the second fluid without interrupting the operation of the modular fluid delivery system. The inlet tubes 910'a, 910'b are at least partially received in corresponding branches 841'a, 841'b of the second inlet fluid circuit pathway 840' of the disposable pump module 800. Furthermore, the common intermediate inlet tube 910'c is received in a common branch 841'c of the second inlet fluid circuit pathway 840', and the final inlet tubes 910'd, 910'e are received in corresponding branches 842', 843' of said second inlet fluid circuit pathway 840'.

[0204] Further, the second outlet fluid circuit tube 920' has two separate branches which are respectively received within the first outlet pathway 851' and the second outlet pathway 852', while the second recirculation fluid circuit tube 930' is received within the second recirculation fluid circuit pathway 860'.

[0205] According to the first embodiment, the first inlet fluid circuit tube 910 of the first fluid circuit X comprises two distal ends and one proximal end. In particular, the two distal ends connect to the first inlet port 823 of the first sub-chamber 821 and the second inlet port 824 of the second sub-chamber 822, respectively, while the proximal end comprises a first connector 940 for fluidly engaging a fluid supply reservoir or a fluid supply station (not shown) of the first fluid. In contrast thereto, the second inlet fluid circuit tube 910' of the second fluid circuit Y comprises two distal ends and two proximal ends. In particular, the two distal ends respectively connect to a second inlet port 823' of a first sub-chamber 821' of the second chamber 820' and a second inlet port 824' of a second sub-chamber 822' of the second chamber 820', while the two proximal ends each comprise a second connector 940' for fluidly engaging a fluid supply reservoir or fluid supply station (not shown) of a second fluid.

[0206] Furthermore, the first outlet fluid circuit tube 920 comprises two proximal ends and one distal end, in particular the two proximal ends connect to the first outlet port 853 of the first sub-chamber 821 and the second outlet port 854 of the second sub-chamber 822, respectively, while the distal end leads into a common outlet tube 950.

[0207] According to an alternative embodiment, the distal ends of the first inlet fluid circuit tube 910 and the second inlet fluid circuit tube 910' terminate flush with the proximal port 849 of the first inlet fluid circuit pathway 840 and the proximal port 849' of the second inlet fluid circuit pathway 840', and thus the first and second connectors 940, 940' are directly associated with said proximal ports to fluidly connect and directly engage the first and second fluid supply reservoirs.

[0208] According to the embodiment shown in FIG. 12, the common outlet tube 950 is received within the common outlet pathway 857 and seats 858 and 859, so that the bubble detector 880 and pressure sensor(s) can perform their associated detection and measurement on the first and second fluids pressurized by the disposable pump module assembly 1000 near their outlets.

[0209] Preferably, the axial end of the common outlet tube 950 is provided with an additional connector (not shown in FIG. 12) for discharging the pressurized fluid exiting the disposable pump module assembly 1000. When the disposable pump module assembly is applied in the medical field (e.g., for injecting contrast agents and saline into a patient's vasculature or organs for proper imaging thereof), the distal end connector can fluidly engage additional tubing (typically designated as a patient line), thereby ensuring that the disposable pump module assembly is not cross-contaminated when a new patient is connected to the same disposable pump module assembly that has already been used for one or more previous patients.

[0210] According to a further embodiment (e.g. as shown in FIG. 12), the fluid circuit tube 900 does not have to be a continuous tube or a branch of an unbroken continuous tube that is received along the entire longitudinal extension of the inlet, outlet and recirculation fluid circuit pathways. In fact, the main part of the fluid circuit pathway (created when creating the support element 810, e.g. by associating together two molded parts that form said support element) already defines a conduit that can carry the fluid while it flows along inside the disposable pump module. Thus, according to said further embodiment, the fluid circuit tube 900 comprises only some very short tube sections that are required to be mainly provided at the sensing locations of the disposable pump module, where detection and measurement of some specific properties of the fluid should be performed or where specific actions are required to be performed on the fluid flow. For example, a tube segment is typically required to be present in correspondence with a first seat 844, 844', which is the location where a supply station valve 870 is operated to act on (e.g., clamp) the tube segment to control whether or not fluid enters the disposable pump module. As a further example, a tube segment is typically required to be present in correspondence with a second seat 845, 845', as well as seat 858, which is the location where an air bubble detector 880 is operated to ascertain the presence, number and / or size of air bubbles contained within the flowing fluid. As a further example, the tube portion is typically required to also correspond to seat 863, 863', which is the location where actuator 890 is operated to act on (e.g. clamp) said tube portion to control whether or not fluid passes through first and second recirculation fluid circuit pathways 860, 860'. Additionally, the tube portion is typically required to also correspond to seat 859, which is the location where at least one pressure sensor is received to measure pressure values ​​of the flowing fluid.

[0211] 11 and 12 also show an extension 828 of the piston rod 826 which engages a suitable gear 829 (shown diagrammatically) for connecting the piston 825 to the drive unit M. Preferably, the gear 829 is not part of the disposable pump module assembly 1000 but is included within the modular fluid delivery system (and thus is part of the injector head if the latter is an injector for use in the medical field).

[0212] It may be pointed out that the disposable pump module assembly 1000 can be used not only when one fluid or two distinct fluids are supposed to be delivered, but also advantageously when a mixture of two distinct fluids is supposed to be delivered. This option can be achieved well thanks to the fact that, according to the embodiment shown in Fig. 12, the second inlet fluid circuit tube 910' of the second fluid circuit Y comprises two inlet tubes 910'a, 910'b that are not necessarily required to be connected to two supply stations containing the same fluid. Indeed, as an alternative embodiment, the inlet tube 910'a can be connected to a supply station containing a given first fluid and the inlet tube 910'b can be connected to a supply station containing a given second fluid different from said given first fluid. Thus, the modular fluid delivery system of the present disclosure can be operated (by appropriately acting on the supply valves 870, 870' received in the corresponding seats 844 and 844') such that a quantity of said predetermined first fluid and a quantity of said predetermined second fluid are supplied to the first and second sub-chambers 821', 822' and, thanks to fluid recirculation through the second recirculation fluid circuit tube 930', said predetermined first and second fluids are mixed together and therefore the mixture is appropriately discharged from the second outlet fluid circuit tube 920'.

[0213] This embodiment is particularly advantageous when the modular fluid delivery system of the present disclosure is an injector suitable for use in the medical field, and the first fluid flowing in the first fluid circuit X is a saline solution, while the inlet tube 910'a connects to a supply station containing a predetermined contrast agent and the inlet tube 910'b connects to a supply station containing said saline solution. Thus, by acting appropriately on the supply valves 870' received in the corresponding seats 844', a predetermined amount of saline solution and a predetermined amount of contrast agent are appropriately supplied to the first and second sub-chambers 821', 822'. Thus, thanks to the recirculation of these fluids through the second recirculation fluid circuit tube 930', the saline solution and the contrast agent can be mixed together in a predetermined ratio, thereby creating, on-site, a quantity of contrast agent of a desired concentration, advantageously tailored to the particular patient under examination. Thus, said modular fluid delivery system can be suitably used for sequentially injecting (according to a predetermined injection protocol) saline solution through the first fluid circuit X and contrast agent of a desired concentration through the second fluid circuit Y.

[0214] According to a further embodiment of the present disclosure shown in Figures 13 and 14, a disposable pump module assembly 2000 comprises three separate fluid circuits X, Y, Z arranged in series and provided on the same common support element 2010. Figure 13 clearly shows that the support element 2010 is preferably formed of two separate layers 2020, 2030 that are assembled together according to any suitable technique as described above. Each layer has predetermined recesses (i.e. tracks or grooves) suitably designed and sized to form the main components that the disposable pump module has (e.g. chambers, various fluid pathways, various seats for receiving valves, actuators, detectors, sensors, filters) when the two separate layers 2020, 2030 are irreversibly assembled together, said components being thus embedded within the thickness of the support element 2010.

[0215] The disposable pump module assembly 2000 will not be described in detail to avoid unnecessary and redundant repetition, however, the various components of each single fluid circuit X, Y, Z as well as their operation are identical or very similar to those shown in Figures 9-12 and have been previously described in this description with respect to said figures.

[0216] According to the embodiment, the disposable pump module assembly 2000 can be used in the modular fluid delivery system of the present disclosure, where three different fluids can be selected to be delivered, each fluid being provided to flow in a given fluid circuit. For example, if the modular fluid delivery system is an injector suitable for use in the medical field, the first fluid flowing in the first fluid circuit X can be a saline solution, the second fluid flowing in the second fluid circuit Y can be a first contrast agent, and the third fluid flowing in the third fluid circuit Z can be a second contrast agent, the second contrast agent being different from the first contrast agent. Alternatively, the first contrast agent and the second contrast agent are the same contrast agent (i.e., the same chemical compound) but different concentrations of the same active substance (e.g., Isovue® from Bracco available as Isovue®-200, Isovue®-250, Isovue®-300 and Isovue®-370 based on the iopamidol concentration contained therein). Thus, by providing the modular fluid delivery system of the present disclosure comprising the disposable pump module assembly 2000, an operator can select which fluid(s) or mixture of fluids to inject based on the specific needs that can be tailored to a given patient and the examination required to be performed. As described above with respect to further embodiments of the present disclosure, the high flexibility of the modular fluid delivery system allows the operator to possibly select among many procedure options: for example, injecting one single contrast agent with flowing saline (typically occurring in MRI procedures), or sequentially injecting saline solution and a given contrast agent according to a predetermined injection protocol (typically occurring in CT procedures), potentially selecting among more than one immediately available contrast agent, or even premixing a given contrast agent with saline solution in a predetermined ratio to continuously inject said contrast agent of a matched concentration into the patient, etc.According to a particularly advantageous configuration of said embodiment, the modular fluid delivery system of the present disclosure may comprise a saline solution supply station and only one contrast agent supply station, said contrast agent being selected in the highest available concentration (among those having the same desired chemical composition appropriate for the examination to be performed). Indeed, thanks to the above-mentioned mixing procedure, by appropriately calculating the proportions of saline solution and contrast agent, it is possible to dilute a highly concentrated contrast agent to obtain a contrast agent at a desired concentration value.

[0217] According to a further embodiment, Figure 15 shows a disposable pump module assembly 3000 with three separate fluid circuits similar to the embodiment shown in Figure 14. However, each inlet fluid circuit tube 3010, 3020, 3030 of each fluid circuit has only one single tube for connecting to a corresponding fluid supply station (not shown).

[0218] As already mentioned above, the applicant has recognized the need to provide a highly flexible modular fluid delivery system to meet the many different operational applications that may be required by a given customer. For example, if the fluid delivery system is an injector suitable for use in the medical field, the applicant has envisaged the need to provide a single device designed according to a modular concept, which is versatile and can be adapted to many different operational conditions as well as many different uses.

[0219] Fig. 16 shows a highly schematic perspective view of one embodiment of a modular fluid delivery system 4000 according to the present disclosure. In detail, the modular concept of the modular fluid delivery system 4000 is obtained by envisaging a number of slots 4010, 4020, 4030, 4040, 4050, each suitable for receiving, for example, a disposable pump module assembly 700 of Fig. 10. According to this particular embodiment, all available slots are identical to each other, and each slot is designed and sized to receive a disposable pump module assembly 700, which represents the most basic and simple structure, since only one single fluid circuit is envisaged through which a single predefined fluid can flow. It can be seen that said modular fluid delivery system represents a satisfactory and very easily adaptable scalable solution to many situations in which many different fluids are required to be controlled and delivered from time to time. For example, if the modular fluid delivery system 4000 is an injector suitable for use in the medical field, said injector may comprise multiple fluid supply stations (only two 4060, 4070 are shown in FIG. 16) (e.g., a reservoir containing saline solution, multiple reservoirs each containing a different contrast agent, multiple reservoirs each containing the same contrast agent but at different concentrations, a reservoir containing a specific medication, etc.) and a desired number of disposable pump module assemblies fluidly connected to one or more of said fluid supply stations depending on the specific examination to be performed on a given patient. As mentioned above, FIG. 16 represents a sketch (not a technical drawing) of a modular fluid delivery system, and therefore the fluid supply stations 4060, 4070 and the fluid circuit tubes connected thereto, as well as the necessary mechanical connections (e.g. by gears) to one or more drive units are only partially shown or not shown at all. For example, the outlet tube 4080 exiting the modular fluid delivery system 4000 (at its free axial end) is provided with a connector 4090 that can be used to fluidly connect the modular fluid delivery system to a patient line or catheter (not shown in FIG. 16).

[0220] According to a further embodiment shown in FIG. 17, the modular fluid delivery system 5000 is designed to receive and fit several disposable pump module assemblies of any type disclosed above. For example, FIG. 17 shows the disposable pump module assembly 1000 of FIG. 12 mounted on (i.e. housed within) the modular fluid delivery system 5000. However, any other disposable pump module assembly can be mounted on the modular fluid delivery system of the present disclosure to enable the operator to meet all possible needs / requests from the field during daily work activities. Thus, the modular fluid delivery system of the present disclosure can be advantageously used to control and deliver different fluids (as described above) and can also be operated in very different contexts. For example, when a medical field application is considered, said modular fluid delivery system can be envisaged to selectively perform CT, MR and / or angiography examinations according to the specific medical needs of a given patient to be treated. It should be emphasized that since the above types of examinations require significantly different operational and environmental conditions, they are conventionally performed by using separate and dedicated injectors (i.e., CT injectors, MRI injectors, or angiography injectors). In contrast, the modular fluid delivery system of the present disclosure can be equipped with dedicated engagements (e.g., slots or housings) suitable for receiving disposable pump module assemblies, each used for a specific examination. It is therefore clear that the modular fluid delivery system of the present disclosure can be very versatile, with one single device (e.g., injector) being able to be used to perform very different examinations, such as CT, MR, and angiography procedures.

[0221] The modular fluid delivery system 5000 of Fig. 17 represents only a sketch. Thus, the fluid supply stations 5010, 5020 and the fluid circuit tubing connected thereto, as well as all necessary mechanical connections (e.g., via gears) to one or more drive units, are only partially shown or not shown at all. For example, the outlet tube 5030 exiting the modular fluid delivery system 5000 comprises (at its free axial end) a connector 5040 that can be used to fluidly connect the modular fluid delivery system to a patient line or catheter (not shown in Fig. 17).

[0222] Modifications In order to meet local and specific requirements, those skilled in the art may apply many logical and / or physical modifications and changes to the present disclosure. More specifically, although the present disclosure has been described with a certain degree of particularity with respect to one or more embodiments thereof, it should be understood that various omissions, substitutions and changes in form and details, as well as other embodiments, are possible. In particular, different embodiments of the present disclosure may be practiced without specific details (e.g., numerical values) set forth in the preceding description to provide a more thorough understanding. Conversely, well-known features may be omitted or simplified so as not to obscure the description with unnecessary details. Furthermore, it is expressly intended that a specific element and / or method step described in connection with any embodiment of the present disclosure may be incorporated into any other embodiment as a general design choice. In any event, each numerical value should be read as qualified by the term "about" (unless already done), and each range of numerical values ​​should be intended to expressly identify any possible number along the continuum within that range (including its endpoints). Furthermore, order or other modifiers are used merely as labels to distinguish between elements having the same name, and no priority, superordinate or ordering is implied by them.The terms "include," "comprise," "have," "contain," and "involve" (and any forms thereof) are intended in an open, non-exhaustive sense (i.e., not limited to the listed items); the terms "based on," "dependent on," "according to," and "function of" (and any forms thereof) are intended in a non-exclusive relationship (i.e., involving a variety of possible further items); the term "a / an" is intended to mean one or more items (unless expressly indicated otherwise); and the term "(means for)" (or any means-plus-function form) is intended to mean any structure adapted or configured to perform the relevant function.

[0223] According to one embodiment of the present disclosure (not shown in the figures), the volume of the supply station is significantly larger than the volume of the chamber of the fluid delivery system. This aspect is particularly advantageous as it ensures that many deliveries (e.g., injections) can be performed without the need to frequently change the fluid reservoir, and further ensures that the overall size of the fluid delivery system can be advantageously minimized, thereby making it more flexible, less cumbersome, more portable (if necessary), and less expensive.

[0224] According to one embodiment of the present disclosure, the modularity of the fluid delivery system can advantageously allow for the selection of a disposable pump module assembly whose relevant components have a size that appropriately correlates with the volume of fluid(s) required to be delivered in the particular application under consideration. For example, when the modular fluid delivery system of the present disclosure is used to replace a traditional power injector for an MRI procedure, due to the fact that MRI contrast agents are typically injected in smaller amounts relative to CT contrast agents, the volume (i.e., size) of the chamber of the disposable pump module that receives and manages the MRI contrast agent can be designed to be appropriately small. This aspect is particularly advantageous because it not only allows for an appropriate reduction in the overall size of the disposable pump module assembly (thereby making it less expensive and easier for the operator to handle), but also contributes to avoiding waste of expensive contrast agents since the fluid delivery system essentially only operates (i.e., supplies from the relevant supply station, distributes along the relevant fluid circuit, manages in the chamber, and delivers from the chamber) the contrast volume that is required to be injected.

[0225] According to a further embodiment of the present disclosure (not shown in the figures), when the disposable pump module assembly comprises more than one chamber, the chambers can have different volumes from each other. For example, a chamber for receiving contrast agent can have a smaller volume than an adjacent chamber for receiving saline solution, since injection protocols for CT examinations typically require a larger amount of saline solution relative to the amount of contrast agent used (for example).

[0226] Furthermore, independent of the particular fluid being delivered, the volume of the chamber(s) of the disposable pump module assembly can be sized to a minimum volume (thereby benefiting from the advantages described above) even though the volume of the delivered fluid may be quite large. This aspect can be achieved by virtue of the design of the disposable pump module assembly of the present disclosure, i.e., the arrangement of its relevant components and their interconnections and couplings with other relevant components of the modular delivery system (e.g., the drive unit(s) and the processor). For example, by increasing the axial speed of the piston back and forth within the chamber, it is possible to deliver a large volume of fluid while using a chamber of a somewhat smaller volume of fluid.

[0227] As mentioned above, the disposable pump module assembly shown in FIG. 12 comprises one common piston 825 axially reciprocated in the first and second chambers 820, 820′. According to an alternative embodiment (not shown), each separate fluid circuit X, Y comprises a chamber having a corresponding dedicated piston. Each dedicated and separate piston may be connected to the same drive unit (e.g., via a suitable gearbox) or, as a further alternative, each dedicated and separate piston is connected to two separate drive units. Of course, the same concept can be applied to disposable pump module assemblies with more than two fluid circuits (e.g., the disposable pump module assembly 2000 of FIG. 14).

[0228] The disposable pump module assembly of the present disclosure can be connected to the drive unit of the modular fluid delivery system by providing a free axial end of the piston rod (i.e., the end of the piston rod that is outside the associated chamber and not integral with the piston flange) with a connecting element (e.g., an outer flange) that can be engaged by any suitable retention mechanism or retention and locking mechanism controlled by the drive unit.

[0229] According to alternative embodiments of the modular fluid delivery system of the present disclosure (not shown), different arrangements of the slots and thus the corresponding disposable pump module assemblies received therein are envisaged. Different spatial configurations (e.g., different from the vertical arrangement shown in FIG. 16) can contribute to identifying different technical solutions as well as giving different shapes and encumbrances to the modular fluid delivery system. For example, according to the embodiment of FIG. 16, the disposable pump module assemblies can be envisaged to be arranged (and thus operated) in parallel with each other. In contrast thereto, according to said further alternative embodiment, some slots can be arranged in a vertical arrangement and some others in a horizontal arrangement. Thus, disposable pump module assemblies on the same horizontal plane can be arranged in series and their respective pistons can be connected with the same gear (not shown) and / or the same drive unit (not shown).

[0230] According to a further embodiment of the modular fluid delivery system of the present disclosure (not shown in the figures), instead of arranging the disposable pump module assemblies in suitable slots (i.e., seats of suitable size for receiving and securely and properly engaging the assemblies, e.g., housings made inside the body of the modular fluid delivery system) distributed in a configuration of multiple rows (e.g., along a line in a vertical or horizontal array, or along multiple lines in a combination of vertical and horizontal arrays), the assemblies can be arranged along a circular path (e.g., the cylinder of a revolver), which is rotatable and defines delivery positions at which selected (i.e., selected based on the particular application under consideration) assemblies are positioned for operation by the system.

[0231] The following are preferred aspects and embodiments of the present disclosure. 1. A modular fluid delivery system (4000; 5000), comprising: [1] at least one supply station (4060; 4070; 5010; 5020) for supplying at least one fluid; and [2] a pressurizing unit (20; 220) for pressurizing said at least one fluid, Equipped with wherein said pressurizing unit comprises at least one drive unit (M) and at least one disposable pump module assembly (700; 1000; 2000; 3000), The at least one disposable pump module assembly is characterized by comprising the following [A] and [B]: [A] at least one disposable pump module (500; 800); wherein said at least one disposable pump module comprises a support element (510; 810; 2010) defining: [A-1] at least one chamber (520; 820; 820') for receiving a piston (525; 825) therein; wherein said piston has a plunger (527; 827; 827') which cooperates with the inner wall of said chamber to define first (521; 821; 821') and second (522; 822; 822') variable volume sub-chambers. [A-2] at least one inlet fluid circuit pathway (540; 840; 840'); [A-3] at least one outlet fluid circuit pathway (550; 850; 850'), and [A-4] At least one recirculation fluid circuit pathway (560; 860; 860'); and [B] Fluid circuit tube (600; 900) comprising: [B-1] at least one inlet fluid circuit tube (610; 910; 910') at least partially received within said at least one inlet fluid circuit pathway (540; 840; 840'); wherein said at least one inlet fluid circuit tube (610; 910; 910') is in fluid communication with said at least one supply station and said at least one chamber for supplying said at least one fluid to said first and second variable volume sub-chambers. [B-2] at least one outlet fluid circuit tube (620; 920; 920') at least partially received within said at least one outlet fluid circuit pathway (550; 850; 850'); wherein said at least one outlet fluid circuit tube (620; 920; 920') is in fluid communication with said at least one chamber for discharging said fluid from either one of said first and second variable volume sub-chambers, said outlet fluid circuit tube being separate from said inlet fluid circuit tube. and [B-3] at least one recirculation fluid circuit tube (630; 930; 930') at least partially received within said at least one recirculation fluid circuit pathway (560; 860; 860'); wherein said at least one recirculation fluid circuit tube fluidly communicates said first and second variable volume subchambers. Modular fluid delivery system (4000; 5000).

[0232] 2. The at least one inlet fluid circuit pathway (540; 840; 840') comprises a first inlet pathway (541; 841; 841'); 2. A modular fluid delivery system (4000; 5000) as described in embodiment 1, characterized in that the first inlet pathway branches into a second inlet pathway (542; 842; 842') and a third inlet pathway (543; 843; 843') in fluid communication with the first sub-chamber (521; 821; 821') and the second sub-chamber (522; 822; 822'), respectively.

[0233] 3. A modular fluid delivery system (4000; 5000) as described in embodiment 2, characterized in that the first inlet pathway (541; 841; 841') comprises a first seat (544; 844; 844') for receiving a supply station valve (870; 870').

[0234] 4. A modular fluid delivery system (4000; 5000) as described in embodiment 2, characterized in that the first inlet pathway (541; 841; 841') comprises a second seat (545; 845; 845') for receiving an air bubble detector (880; 880').

[0235] 5. A modular fluid delivery system (4000; 5000) as described in embodiment 2, characterized in that the first inlet pathway (541; 841; 841') comprises a third seat (546; 846; 846') for receiving a filtration unit.

[0236] 6. A modular fluid delivery system (4000; 5000) as described in embodiment 2, characterized in that the second inlet pathway (542; 842; 842') comprises a seat (547; 847; 847') for receiving a first inlet fluid circuit valve.

[0237] 7. A modular fluid delivery system (4000; 5000) as described in embodiment 2, characterized in that the third inlet pathway (543; 843; 843') comprises a seat (548; 848; 848') for receiving a second inlet fluid circuit valve.

[0238] 8. A modular fluid delivery system (4000; 5000) as described in embodiment 1, characterized in that the at least one outlet fluid circuit pathway (550; 850; 850') comprises a first outlet pathway (551; 851; 851') and a second outlet pathway (552; 852; 852').

[0239] 9. A modular fluid delivery system (4000; 5000) as described in embodiment 8, characterized in that the first outlet pathway (551; 851; 851') comprises a seat (555; 855; 855') for receiving a first outlet fluid circuit valve.

[0240] 10. A modular fluid delivery system (4000; 5000) as described in embodiment 8, characterized in that the second outlet pathway (552; 852; 852') comprises a seat (556; 856; 856') for receiving a second outlet fluid circuit valve.

[0241] 11. A modular fluid delivery system (4000; 5000) as described in embodiment 2, characterized in that the at least one recirculation fluid circuit pathway (560; 860; 860') is outside the at least one chamber (520; 820; 820') and fluidly connects the second inlet pathway (542; 842; 842') to the third inlet pathway (543; 843; 843').

[0242] 12. A modular fluid delivery system (4000; 5000) as described in embodiment 1, characterized in that the at least one recirculation fluid circuit pathway (560; 860; 860') comprises a seat (563; 863; 863') for receiving an actuator (890; 890').

[0243] 13. A modular fluid delivery system (4000; 5000) according to embodiment 12, characterized in that the actuator is an electromechanically actuated valve that is automatically controlled and operated by a processor (P) of the modular fluid delivery system.

[0244] 14. A modular fluid delivery system (4000; 5000) as described in embodiment 1, characterized in that the fluid circuit tube (600; 900) comprises several short tube sections provided at sensing locations of the disposable pump module, the sensing locations being locations where detection of specific properties of the fluid should occur or where a specific action is required to be exerted on the fluid flow.

[0245] 15. A modular fluid delivery system (4000; 5000) according to any one of embodiments 1 to 14, comprising at least one first disposable pump module assembly (700; 1000; 2000; 3000) for delivering at least one first fluid and at least one second disposable pump module assembly (700; 1000; 2000; 3000) for delivering at least one second fluid, the second fluid being different from the first fluid.

[0246] 16. A modular fluid delivery system (4000; 5000) as described in embodiment 15, characterized in that the at least one first disposable pump module assembly and the at least one second disposable pump module assembly are arranged in series and connected to a common drive unit (M).

[0247] 17. A modular fluid delivery system (4000; 5000) as described in embodiment 15, characterized in that the at least one first disposable pump module assembly and the at least one second disposable pump module assembly are arranged in parallel and connected to a common drive unit (M).

[0248] 18. A modular fluid delivery system (4000; 5000) as described in embodiment 15, characterized in that the at least one first disposable pump module assembly and the at least one second disposable pump module assembly are arranged in parallel, the at least one first pump module assembly is connected to a first drive unit of the modular fluid delivery system, and the at least one second pump module assembly is connected to a second drive unit of the modular fluid delivery system.

[0249] 19. The modular fluid delivery system (4000; 5000) of embodiment 1, wherein the at least one disposable pump module assembly (1000; 2000; 3000) comprises at least two separate fluid circuits (X; Y; Z) arranged in series to deliver at least one first fluid and at least one second fluid, the first fluid being different from the second fluid.

[0250] 20. A modular fluid delivery system (4000; 5000) as described in embodiment 8, characterized in that the first outlet pathway (551; 851; 851') and the second outlet pathway (552; 852; 852') convey to a common outlet pathway (857).

[0251] 21. A modular fluid delivery system (4000; 5000) as described in embodiment 20, characterized in that the common outlet pathway (857) comprises a seat (858) for receiving a further air bubble detector (880).

[0252] 22. A modular fluid delivery system (4000; 5000) as described in embodiment 20, characterized in that the common outlet pathway (857) comprises a seat (859) for receiving at least one pressure sensor.

[0253] 23. A modular fluid delivery system (4000) as described in embodiment 1, comprising a plurality of slots (4010, 4020, 4030, 4040, 4050), each slot being provided to receive a disposable pump module assembly (700; 1000; 2000; 3000).

[0254] 24. A modular fluid delivery system as described in embodiment 1, comprising at least two disposable pump module assemblies (700; 1000; 2000; 3000) arranged along a circular path, the circular path being rotatable and defining a delivery position at which a selected assembly is positioned for operation by the modular fluid delivery system.

[0255] 25. The modular fluid delivery system of embodiments 14 and 19, characterized in that the fluid circuit (X; Y; Z) is formed by combining tube portions of the fluid circuit tube (600; 900) and portions of the at least one inlet fluid circuit pathway (540; 840; 840'), portions of the at least one inlet fluid circuit pathway (540; 840; 840') and portions of the at least one recirculation fluid circuit pathway (560; 860; 860').

Claims

1. A modular fluid delivery system (4000; 5000), comprising: [1] at least one supply station (4060; 4070; 5010; 5020) for supplying at least one fluid; and [2] a pressurizing unit (20; 220) for pressurizing said at least one fluid, Equipped with wherein said pressurizing unit comprises at least one drive unit (M) and at least one disposable pump module assembly (700; 1000; 2000; 3000), The at least one disposable pump module assembly is characterized by comprising the following [A] and [B]: [A] at least one disposable pump module (500; 800); wherein said at least one disposable pump module comprises a support element (510; 810; 2010) defining: [A-1] at least one chamber (520; 820; 820') for receiving a piston (525; 825) therein; wherein said piston has a plunger (527; 827; 827') which cooperates with the inner wall of said chamber to define first (521; 821; 821') and second (522; 822; 822') variable volume sub-chambers. [A-2] at least one inlet fluid circuit pathway (540; 840; 840'); [A-3] at least one outlet fluid circuit pathway (550; 850; 850'), and [A-4] at least one recirculation fluid circuit pathway (560; 860; 860'); and [B] A fluid circuit tube (600; 900) comprising: [B-1] at least one inlet fluid circuit tube (610; 910; 910') at least partially received within said at least one inlet fluid circuit pathway (540; 840; 840'); wherein said at least one inlet fluid circuit tube (610; 910; 910') is in fluid communication with said at least one supply station and said at least one chamber for supplying said at least one fluid to said first and second variable volume subchambers. [B-2] at least one outlet fluid circuit tube (620; 920; 920') at least partially received within said at least one outlet fluid circuit pathway (550; 850; 850'); wherein said at least one outlet fluid circuit tube (620; 920; 920') is in fluid communication with said at least one chamber for discharging said fluid from either one of said first and second variable volume sub-chambers, said outlet fluid circuit tube being separate from said inlet fluid circuit tube. and [B-3] at least one recirculation fluid circuit tube (630; 930; 930') at least partially received within said at least one recirculation fluid circuit pathway (560; 860; 860'); wherein said at least one recirculation fluid circuit tube fluidly communicates said first and second variable volume subchambers. Modular fluid delivery system (4000; 5000).

2. 2. A modular fluid delivery system (4000; 5000) according to claim 1, comprising: said at least one inlet fluid circuit pathway (540; 840; 840') comprising a first inlet pathway (541; 841; 841'); said first inlet pathway branches into a second inlet pathway (542; 842; 842') and a third inlet pathway (543; 843; 843') in fluid communication with said first variable volume subchamber (521; 821; 821') and said second variable volume subchamber (522; 822; 822'), respectively; Modular fluid delivery system (4000; 5000).

3. 3. A modular fluid delivery system (4000; 5000) according to claim 2, comprising: said first inlet pathway (541; 841; 841') comprising a first seat (544; 844; 844') for receiving a supply station valve (870; 870'), Modular fluid delivery system (4000; 5000).

4. 3. A modular fluid delivery system (4000; 5000) according to claim 2, comprising: the second inlet pathway (542; 842; 842') comprises a seat (547; 847; 847') for receiving a first inlet fluid circuit valve, Modular fluid delivery system (4000; 5000).

5. 3. A modular fluid delivery system (4000; 5000) according to claim 2, comprising: the third inlet pathway (543; 843; 843') comprises a seat (548; 848; 848') for receiving a second inlet fluid circuit valve, Modular fluid delivery system (4000; 5000).

6. 2. A modular fluid delivery system (4000; 5000) according to claim 1, comprising: The at least one outlet fluid circuit pathway (550; 850; 850') comprises a first outlet pathway (551; 851; 851') and a second outlet pathway (552; 852; 852'), Modular fluid delivery system (4000; 5000).

7. 7. A modular fluid delivery system (4000; 5000) according to claim 6, comprising: the first outlet pathway (551; 851; 851') comprises a seat (555; 855; 855') for receiving a first outlet fluid circuit valve, Modular fluid delivery system (4000; 5000).

8. 7. A modular fluid delivery system (4000; 5000) according to claim 6, comprising: the second outlet pathway (552; 852; 852') comprises a seat (556; 856; 856') for receiving a second outlet fluid circuit valve, Modular fluid delivery system (4000; 5000).

9. 3. A modular fluid delivery system (4000; 5000) according to claim 2, comprising: said at least one recirculation fluid circuit pathway (560; 860; 860') is outside said at least one chamber (520; 820; 820') and fluidly connects said second inlet pathway (542; 842; 842') to said third inlet pathway (543; 843; 843'), Modular fluid delivery system (4000; 5000).

10. 2. A modular fluid delivery system (4000; 5000) according to claim 1, comprising: said at least one recirculation fluid circuit pathway (560; 860; 860') comprising a seat (563; 863; 863') for receiving an actuator (890; 890'), Modular fluid delivery system (4000; 5000).

11. 2. A modular fluid delivery system (4000; 5000) according to claim 1, comprising: the fluid circuit tubing (600; 900) comprises several short tube sections provided at sensing locations of the disposable pump module; the sensing location being a location where detection of a specific property of the fluid is required to occur or a specific action is required to be exerted on the fluid flow; Modular fluid delivery system (4000; 5000).

12. A modular fluid delivery system (4000; 5000) according to any one of claims 1 to 11, comprising: at least one first disposable pump module assembly (700; 1000; 2000; 3000) for delivering at least one first fluid and at least one second disposable pump module assembly (700; 1000; 2000; 3000) for delivering at least one second fluid; The second fluid is different from the first fluid. Modular fluid delivery system (4000; 5000).

13. 2. A modular fluid delivery system (4000; 5000) according to claim 1, comprising: said at least one disposable pump module assembly (1000; 2000; 3000) comprising at least two separate fluid circuits (X; Y; Z) arranged in series to deliver at least one first fluid and at least one second fluid; The first fluid is different from the second fluid. Modular fluid delivery system (4000; 5000).

14. 2. The modular fluid delivery system (4000) of claim 1, comprising: a plurality of slots (4010, 4020, 4030, 4040, 4050), each slot being adapted to receive a disposable pump module assembly (700; 1000; 2000; 3000); A modular fluid delivery system (4000).

15. 10. The modular fluid delivery system of claim 1, at least two disposable pump module assemblies (700; 1000; 2000; 3000) arranged along a circular path; the circular path is rotatable and defines a delivery location at which a selected assembly is positioned for operation by the modular fluid delivery system; Modular fluid delivery system.

16. 14. The modular fluid delivery system of claim 13, comprising: said fluid circuits (X; Y; Z) being formed by combining a tube section of said at least one inlet fluid circuit tube (610; 910; 910'), a tube section of said at least one outlet fluid circuit tube (620; 920; 920') and a tube section of said at least one recirculation fluid circuit tube (630; 930; 930'), Modular fluid delivery system.

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