Multifluid transfer system

Abstract

A fluid transfer system is disclosed comprising at least one first supply station for supplying a first fluid and at least one second supply station for supplying a second fluid different from the first fluid. The fluid transfer system further comprises a pressurizing unit for pressurizing the first and second fluids, wherein the pressurizing unit comprises first and second pump modules, and each pump module comprises a piston provided with a plunger to define a chamber and first and second variable volume subchambers. The fluid transfer system further comprises first and second inlet fluid circuits, first and second outlet fluid circuits, and a first recirculating fluid path fluid-fluidly connecting the first and second variable volume subchambers of the pump modules. Additionally, a first actuator is coupled to the first recirculating fluid path to manage bidirectional fluid passage between the first and second variable volume subchambers of the pump modules. A method of operating the fluid transfer system is also disclosed.

Description

Technology Field

[0001] The present disclosure relates to the field of fluid delivery. More specifically, the present disclosure relates to a fluid delivery system that enables the delivery of two or more fluids under predetermined desired operating conditions. More specifically, the present disclosure relates to an injection system and method for injecting two or more different medical fluids. Background Technology

[0002] The background of the present disclosure is introduced below, along with a discussion of the technology related to the context. However, even if such discussion refers to literature, acts, artifacts, etc., it does not imply or indicate that the technology discussed is part of the prior art or is common general knowledge in the field related to the present disclosure.

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

[0004] For example, the injection of fluids into a patient is common in various medical procedures. For instance, a contrast agent (or contrast medium) may be injected along with saline, if possible, during a patient scan to enhance the contrast of target features (e.g., structures or organs of the human body) within the patient. Particularly in imaging applications (where a visual representation of the inside of the patient is created non-invasively without the use of surgical techniques), the use of a contrast agent makes target features more distinct. As a result, target features that would otherwise be less distinguishable from other nearby features (e.g., surrounding tissues) are advantageously highlighted. This significantly facilitates the clinician's work in diagnostic applications, particularly the identification and / or characterization of lesions, monitoring of progression, or response to medical treatment. For example, iodine-based contrast agents (e.g., iopamidol) are commonly used in computed tomography (CT) applications (e.g., angiographic investigations).

[0005] The contrast agent is generally, preferably, injected into the patient's blood vessels by an automatic injection system. The injection system pressurizes the contrast agent to inject it into the patient's vascular system or trachea under specific injection conditions, e.g., a specific flow rate, a specific volume, and a specific pressure. In this way, the contrast agent can be injected in a controlled, safe, and efficient manner.

[0006] Accordingly, the injection system is typically provided with one or more supply stations for supplying contrast agent and / or saline from corresponding containers (e.g., bottles, bags, or pouches). The injection system is also provided with a delivery arrangement (i.e., a combination of piping lines) that fluidly communicates with at least one supply station and a pressurization unit. Since the delivery arrangement is located upstream of the pressurization unit and is not directly connected to the patient, and the risk of cross-contamination is minimal or very low, the delivery arrangement is typically a disposable element that is discarded periodically (e.g., every 10 or 12 hours). This means that the delivery arrangement is not replaced when a new patient undergoes examination, and is typically kept in place for multiple consecutive injections (and consequently multiple consecutive patients) until the predetermined period designed for the delivery arrangement has fully elapsed.

[0007] Powered injection systems known in the industry and currently available on the market are classified into two main groups: syringe injectors (such as Empower CTA® or Empower CTA®+ manufactured by Bracco Injeneering SA) and syringe-less injectors (such as CT Expres® manufactured by Bracco Injeneering SA).

[0008] Syringe injectors can benefit from syringe / piston technology, which ensures fluid delivery accuracy and precision along with the injection of high-pressure fluids. Nevertheless, syringe injectors have several disadvantages, primarily in terms of cumbersome syringe workflow (in terms of mounting and dismounting the syringe from the injector head, filling the syringe with the fluid to be injected, and syringe priming and purging), significant syringe (i.e., consumable) costs, and troublesome waste management (i.e., the inevitable disposal of expensive contrast agents remaining in syringes that are not injected into the patient and cannot be reused).

[0009] On the other hand, syringeless injectors offer the benefits of a more efficient and streamlined workflow by facilitating waste management. This is achieved by using bottles / bags (instead of syringes) to deliver larger volumes of contrast agent available for multiple patients, thereby significantly reducing contrast agent waste as only the consumable patient line is discarded with each new patient. Nevertheless, because the primary technology used in syringeless injectors is a peristaltic pump (consumable or reusable) due to its fundamental nature, this technology cannot achieve significantly higher pressures and flow rates compared to syringe injectors (particularly in consumable peristaltic pump specifications) and may generate adverse fluctuations in flow rate and / or pressure during operation, which can contribute to a reduction in the delivery accuracy of the fluid delivery system to some extent.

[0010] Recently, some specific medical procedures also require electric injectors to be able to provide high-demanding hydraulic performance, particularly in terms of the pressure and flow rate of the fluid to be injected into the patient.

[0011] For example, it is becoming increasingly common for electric injectors to be already implanted in the patient's vascular structure and connected to implantable devices (e.g., PICC and PORT) used to establish endovascular access to the patient.

[0012] A PICC is a Peripherally Inserted Central Catheter typically placed in a patient's arm to allow for long-term intravenous access, such as prolonged antibiotic treatment or chemotherapy. The PICC is inserted into a peripheral vein (e.g., the head vein, basilar vein, or brachial vein) and then advanced toward the heart through progressively larger veins until the catheter tip settles within the distal superior vena cava or the sinoatrial junction, while the proximal end of the PICC remains outside the body. The PICC typically remains in the patient's arm for a period ranging from 6 weeks to 1 year.

[0013] A PORT generally includes a reservoir (portal) (provided with a diaphragm for needle insertion) and a catheter leading from the reservoir to the patient's vein. The reservoir is surgically inserted under the skin of the upper chest or arm, and the catheter is fully inserted into the vein. In other words, there is no catheter tail outside the patient's body.

[0014] Therefore, some patients who need to undergo imaging examinations (e.g., computed tomography - CT) may already have PICCs and PORTs for other purposes. Thus, existing multi-lumen PICCs can be advantageously utilized by medical personnel for diagnostic and / or motorized injection of therapeutic agents. However, the presence of the implanted device inevitably presents technical limitations for motorized injectors (particularly in the case of motorized syringeless injectors) that require generating sufficiently high pressure and flow rate values ​​to ensure a certain desired injection performance, even when the implanted device is interposed between the injection system and the patient.

[0015] WO 2016 / 033351 discloses an infusion system comprising a dual-acting infusion pump. The pump comprises a cylinder and a reciprocating piston housed within the cylinder, wherein the reciprocating piston separates 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 a filling state and a discharge state by the reciprocating motion of the reciprocating piston through the operation of the reciprocating motor, and the reciprocating speed is varied to provide a continuous output of fluid between the first pump chamber and the second pump chamber. A fluid source and a catheter are optionally coupled to the dual-acting infusion pump. The catheter comprises one or more infusion ports near the distal end of the catheter, and the one or more infusion ports receive and discharge a continuous output of fluid from the dual-acting infusion pump.

[0016] DE 10 2011 120 105 discloses an apparatus having a container having an opening into which a movable piston is disposed. A piston rod is provided to displace the piston within the container. The container is divided into chambers. A flexible sealing element is provided to close the opening of the container. Two inlet ducts communicate with a media supply line and the chambers, respectively. Two outlet ducts communicate with a media supply line and the chambers, respectively.

[0017] Medical applications and other technical fields may also require the delivery of a composition under specific predetermined conditions.

[0018] For example, an adhesive formulation may need to be delivered only when appropriate operating conditions are guaranteed, such as when a given homogeneity of the adhesive formulation components is achieved. Therefore, a dedicated delivery system for applying the adhesive formulation in a given environment must ensure that the adhesive formulation is actually delivered only when the desired homogeneity is obtained, so that efficient and accurate action of the adhesive can be achieved.

[0019] Ensuring the desired homogeneity is required, especially in the process of preparing paint compositions or coating compositions that are executed immediately before application in the automotive industry, aerospace industry, housing equipment industry, etc.

[0020] According to another possible application, the delivery system may be required to begin delivering a given composition only when a specific characteristic threshold is achieved, for example, when a predetermined temperature value is reached. Accordingly, the delivery system must ensure that the temperature value is effectively obtained and that appropriate (typically slow) heat distribution occurs within the composition.

[0021] The aspects described above are not applicable only to existing industries (e.g., pharmaceutical, chemical, automotive, and aerospace industries) where mixing or shaking steps must be performed before the final delivery / application step is executed. In fact, cellular and biological applications may also require that specific conditions be maintained or achieved before moving to subsequent steps. For example, many experiments involving cell culture use bovine serum, which generally requires regular mixing by careful swirling before use to maintain its original structural state.

[0022] Accordingly, the applicant recognized the need to improve the hydrodynamic performance of a fluid transfer system that ensures high accuracy and high precision during transfer, while ensuring that two or more different (i.e., separate) fluids can be transferred at sufficiently high pressure (if necessary) and sufficiently high flow rate (if necessary).

[0023] Specifically, in relation to the medical field, particularly regarding the injection or infusion of liquid agents or diagnostic active contrast agents into a patient's body (generally into the patient's blood vessels reaching the patient's body parts or organs to be treated and / or analyzed via scan examinations such as X-ray, CT, MRI, or ultrasound), the applicant recognized the need to improve the hydrodynamic performance of an electric injector (primarily in terms of the maximum pressure and maximum flow rate of the injected fluid) so that a given injection procedure is not affected by any additional medical device (e.g., PICC and PORT) that is already implanted in the patient's body and to which an electric injector is required to be connected.

[0024] Furthermore, the need to improve the hydrodynamic performance of electric injectors is also related to the fact that increasingly viscous contrast agents are being introduced to the market, and this increased viscosity generally reduces injector delivery performance in terms of the maximum pressure and maximum flow rate of the injected fluid. Even in the worst-case scenario, this delivery performance is sometimes negatively affected by the custom in some specific countries of injecting fluids at room temperature—that is, without preheating the fluid to approximately body temperature before injection—and this preheating actually contributes favorably to reducing the viscosity of the contrast agent.

[0025] Accordingly, the applicant has also recognized the need to improve the capability of a fluid delivery system for delivering fluids that satisfy specific predetermined fluid characteristics required for the proper use of the fluid. In other words, the applicant has recognized the need to provide a fluid delivery system that satisfies and guarantees the delivery conditions required for a specific fluid to be delivered, while ensuring that the delivery system is accurate, precise, efficient, reliable, and simple in terms of ease of use and the method of manufacturing.

[0026] The applicant has also recognized the need to improve the delivery performance and accuracy of a fluid delivery system required to deliver at least two different fluids having different characteristics / properties (e.g., contrast agents with different viscosities, saline solutions, mixtures thereof) sequentially and / or alternately. In fact, delivering at least two different fluids in an alternating sequence requires corresponding alternating opening / closing steps of different fluid paths through which the different fluids flow, and these steps can cause the generation of bubbles within the fluid paths due to cavitation and may also cause under-pressure or over-pressure events that can negatively affect the fluid flow rate, for example, in terms of the desired flow rate value provided by the fluid delivery system and / or in terms of ensuring the regularity and continuity of the fluid flow. Furthermore, the alternating opening / closing steps of different fluid paths require a valve or clamp to be operated on the high-pressure side of the fluid flow, and this aspect is very difficult and demanding for the very precise and accurate operation of the fluid delivery system. means of solving the problem

[0027] A simplified summary of the present disclosure is presented herein to provide a basic understanding of the disclosure; however, the sole purpose of this summary is to introduce some concepts of the disclosure in a brief form as a preface to the following more detailed description, and it should not be interpreted as an identification of key elements or a description of the scope.

[0028] In order to provide a fluid delivery system capable of delivering at least two different fluids and accurately and precisely achieving desired / specified delivery conditions (e.g., in terms of pressure and flow rate) for each fluid, the applicant has found to provide a fluid delivery system having at least two pump modules, wherein each pump module handles at least one fluid, and at least one pump module includes a dedicated recirculation fluid circuit (sometimes also defined as a recirculation fluid path in this description) for internally recirculating at least one fluid to a corresponding pump module when it is required that, during the operation of the fluid delivery system, the at least one fluid not be delivered outside the fluid delivery system (i.e., not discharged from the pump module and not delivered by the fluid delivery system).

[0029] Accordingly, an embodiment of the present disclosure relates to a fluid transfer system,

[0030] - At least one first supply station for supplying a first fluid and at least one second supply station for supplying a second fluid different from the first fluid;

[0031] - As a pressurizing unit for pressurizing the first fluid and the second fluid,

[0032] A first pump module comprising a first chamber and a first piston accommodated within the first chamber, wherein the first piston is configured to have a first plunger that cooperates with the inner wall of the first chamber to define first and second variable volume subchambers of the first chamber; and

[0033] A pressurizing unit comprising: a second pump module including a second chamber and a second piston accommodated within the second chamber, wherein the second pump module is configured to have a second plunger that cooperates with the inner wall of the second chamber to define the first and second variable volume sub-chambers of the second chamber;

[0034] - A first inlet fluid circuit fluidly communicating with the at least one first supply station and the first pump module to supply the first fluid to the first and second variable volume subchambers of the first chamber;

[0035] - A second inlet fluid circuit fluidly communicating with the at least one second supply station and the second pump module to supply the second fluid to the first and second variable volume sub-chambers of the second chamber;

[0036] - A first recirculating fluid circuit fluidly connecting the first and second variable volume subchambers of the first chamber; and

[0037] - A fluid transfer system is provided comprising a first actuator for managing bidirectional fluid passage between the first and second variable volume sub-chambers of the first chamber, wherein the first actuator is part of the first recirculating fluid circuit.

[0038] According to another embodiment of the present disclosure, in order to provide a fluid delivery system capable of ensuring the delivery of at least two different fluids and accurately and precisely achieving desired / determined delivery conditions (e.g., in terms of pressure and flow rate) for each fluid, the applicant has found to provide a fluid delivery system having at least two pump modules, wherein each pump module handles at least one fluid, and each pump module includes a dedicated recirculation fluid circuit (sometimes also defined as a recirculation fluid path in this description) for internally recirculating said at least one fluid to a corresponding pump module when it is required that said at least one fluid not be delivered outside the fluid delivery system (i.e., not discharged from said pump module and ultimately not delivered by the fluid delivery system) during the operation of the fluid delivery system.

[0039] Additionally, the present applicant has discovered a method for operating a fluid transfer system for transferring at least a first fluid and a second fluid different from the first fluid, comprising the step of transferring one of the first or second fluids (to the outside of the fluid transfer system) while the other of the first or second fluids is recirculated internally within the fluid transfer system. According to this method, as soon as the other fluid is required to be transferred to the outside of the fluid transfer system, the transfer step and the recirculation step are reversed.

[0040] Accordingly, another aspect of the present disclosure is a method of operating a fluid transfer system to transfer at least a first fluid and a second fluid different from the first fluid, wherein

[0041] - A step of delivering the second fluid to the outside of the fluid transfer system;

[0042] - A step of recirculating the first fluid internally within the fluid transfer system; and

[0043] - A method comprising the step of delivering the first fluid to the outside of the fluid delivery system.

[0044] An alternative aspect of the present disclosure is a method of operating a fluid transfer system to transfer at least a first fluid and a second fluid different from the first fluid, wherein

[0045] - A step of delivering the first fluid to the outside of the fluid transfer system;

[0046] - A step of recirculating the second fluid internally within the fluid transfer system;

[0047] - A step of delivering the second fluid to the outside of the fluid transfer system; and

[0048] - A method comprising the step of internally recirculating a first fluid in the fluid transfer system.

[0049] An alternative embodiment of the present disclosure is a method for operating a fluid transfer system, wherein the fluid transfer system comprises at least one first supply station for supplying a first fluid and at least one second supply station for supplying a second fluid different from the first fluid, and the fluid transfer system further comprises a pressurizing unit provided with a first pump module and a second pump module, wherein each of the first and second pump modules each comprises a piston reciprocating within a chamber and, wherein the piston has a plunger that cooperates with the inner wall of the chamber to define first and second variable volume subchambers, and the fluid transfer system further comprises a first recirculating fluid path for fluid-fluidly connecting the first and second variable volume subchambers of the first chamber and a first actuator coupled to the first recirculating fluid path.

[0050] - A step of supplying the first fluid from the first supply station to the first and second variable volume subchambers of the first chamber;

[0051] - A step of supplying the second fluid from the second supply station to the first and second variable volume subchambers of the second chamber;

[0052] - A step of axially translating each piston within the first and second chambers; and

[0053] - A method characterized by including the step of operating the first actuator to recirculate the first fluid within the first chamber.

[0054] According to another embodiment, the applicant has also discovered a method for operating a fluid transfer system to transfer a first fluid and also to transfer a mixture of the first fluid and a second fluid different from the first fluid, comprising: a) transferring the first fluid (outside the fluid transfer system); b) recirculating the first fluid and the second fluid internally within the fluid transfer system to obtain a mixture of the first fluid and the second fluid, preferably performed substantially simultaneously with the step of transferring the first fluid; c) transferring the mixture to the outside of the fluid transfer system; and d) recirculating the first fluid internally within the fluid transfer system, preferably performed substantially simultaneously with the step of transferring the mixture.

[0055] According to an alternative embodiment, the applicant has also discovered a method for operating a fluid transfer system to transfer a first fluid and also to transfer a mixture of the first fluid and a second fluid different from the first fluid, comprising: a) transferring the first fluid (outside the fluid transfer system); b) recirculating the first fluid and the second fluid inside the fluid transfer system to obtain a mixture of the first fluid and the second fluid, preferably performed substantially simultaneously with the step of transferring the first fluid; and c) transferring the mixture outside the fluid transfer system.

[0056] More specifically, one or more aspects of the present disclosure are described in independent claims, their advantageous features are described in dependent claims, and all expressions of the claims are incorporated herein by reference verbatim (any advantageous feature is provided by reference to any specific aspect and applies to all other aspects with only minor modifications as necessary). Brief explanation of the drawing

[0057] The solutions of the present disclosure will be best understood by referring to the following detailed description, given in a purely non-limiting manner, which is read together with the accompanying drawings, along with additional features and benefits (for convenience, corresponding elements are denoted by the same or similar reference numerals, descriptions are not repeated, and generally, the names of each object are used to indicate both types and attributes such as value, contents, and representation). In this regard, by any chance, the drawings do not need to be drawn in proportion (some details may be exaggerated and / or simplified), and unless otherwise stated, the drawings are intended only to illustrate structures and procedures conceptually described herein. FIG. 1 illustrates a schematic diagram of a fluid transfer system according to an embodiment of the present disclosure in which two pump modules are arranged in parallel. FIG. 2 illustrates a schematic diagram of an alternative fluid transfer system of the present disclosure in which two pump modules are arranged in series. FIG. 3 illustrates a schematic diagram of an alternative arrangement of the embodiment of FIG. 2. FIG. 4 illustrates a schematic diagram of an alternative solution to the embodiment of FIG. 1. FIG. 5 illustrates a schematic diagram of an alternative solution to the embodiment of FIG. 2. FIG. 6 illustrates a schematic diagram of an alternative solution to the embodiment of FIG. 2. FIG. 7 illustrates a schematic diagram of an alternative solution to the embodiment of FIG. 1. FIG. 8 illustrates a schematic diagram of an alternative solution to the embodiment of FIG. 2. FIGS. 9 and 10 illustrate schematic diagrams of the operating steps of the fluid transfer system illustrated in FIG. 2. FIGS. 11 and 12 illustrate schematic diagrams of the operating steps of the fluid transfer system illustrated in FIG. 5. FIG. 13 illustrates a schematic diagram of an alternative solution to the embodiment of FIG. 7. FIG. 14 illustrates a schematic diagram of another alternative solution of the embodiment of FIG. 7. Specific details for implementing the invention

[0058] Referring to FIG. 1, a schematic diagram of a fluid transfer system (100) according to an embodiment of the present disclosure is shown, in which two pump modules (30, 30') are arranged in parallel. The fluid transfer system (100) is used to transfer a first fluid received in a first supply station (10) and a second fluid received in a second supply station (10'), said first fluid and said second fluid are different from each other.

[0059] If the fluid delivery system (100) is an injection system intended for use in the medical field, the first fluid to be received at the first supply station (10) and injected into the patient's vascular system may be a contrast agent administered to enhance the contrast of a target (body) feature (e.g., a structure or organ of the human body) within the patient, for example, during a scan examination, such as a CT, MRI, or ultrasound examination. In particular, in imaging applications (where visual indications within the patient are created in a non-invasive manner without relying on surgical techniques), the use of a contrast agent makes the target feature more distinct. As a result, the target feature, which would otherwise be less distinguishable from other nearby features (e.g., surrounding tissues), is advantageously highlighted. This significantly facilitates the work of a clinician in diagnostic applications, particularly the identification and / or characterization of lesions, monitoring of progression, or response to medical treatment. For example, in CT applications, the contrast agent may be an iodine-based contrast agent including diatrizoate, dioxaglate, iopamidol, iohexol, dioxilane, iopromide, or iodixanol. One example of a commercial contrast agent containing iopamidol is ISOVUE® manufactured by Bracco Diagnostics Inc.

[0060] According to an embodiment of the present disclosure, a fluid delivery system (100) is configured to deliver an ultrasound contrast agent (USCA) in a continuous injection / injection mode and / or as a bolus. In particular, the fluid delivery system (100) is used to deliver a liquid composition comprising a suspension of particulates homogeneously distributed in a liquid carrier, preferably an aqueous liquid carrier, said particulates containing a gas mixture comprising a captured pure gas or one or more physiologically acceptable halogenated gases. The halogenated gas is preferably selected from CF4, C2F6, C3F8, C4F8, C4F10, C5F12, C6F14, or SF6. The gas mixture may also include gases such as air, oxygen, nitrogen, helium, xenon, or carbon dioxide. In some cases, the above particles (microbubbles or microballoons) contain a mixture of at least one perfluorinated gas and nitrogen or air in a proportion that can vary between 1 and 99%. An example of a commercial contrast agent used in contrast-enhanced ultrasound (CEUS) applications is SonoVue® (sulfur hexafluoride microbubbles) manufactured by Bracco Suisse®.

[0061] Still referring to the medical field, the second fluid to be received at the second supply station (10') and injected into the patient's vascular system may be, for example, a saline solution containing a physiological or isotonic solution (e.g., sodium chloride). Alternatively, the first and / or second fluid may be a liquid medicine or drug.

[0062] As already mentioned above, the fluid delivery system (100) of the present disclosure can be used to deliver fluids in many technical fields and is not strictly related to the medical / diagnostic field. For example, the first and second fluids received in the first and second supply stations (10, 10'), respectively, may be two or more components of an adhesive formulation, a painting formulation, a coating formulation, or a material / formulation for which delivery characteristics (e.g., temperature) are required to be appropriately reached / controlled.

[0063] A fluid transfer system (100) comprises a pressurizing unit (20) that operates on the first fluid and the second fluid so that, as disclosed in detail below in this description, the first and second fluids are alternately transferred to the outside of the fluid transfer system (at a predetermined pressure and flow rate based on requirements designed for a specific transfer application and understood by an operator or a fluid transfer system control unit) and recirculated within the fluid transfer system. The pressurizing unit (20) comprises a first pump module (30), a second pump module (30'), and a driving unit (M) connected to the two pump modules for operation / driving thereof. Each pump module (30, 30') comprises a chamber (31, 31') in which a piston (32, 32') inside reciprocates by the driving unit (M) (i.e., moves back and forth - see double arrow (A, A')). According to the embodiment illustrated in the drawing, the chamber (31, 31') is depicted as a cylindrical barrel (e.g., a syringe barrel); however, other shapes suitable for the purpose may also be conceived. Each piston (32, 32') comprises a piston rod (33, 33') and a plunger (34, 34'), and each plunger (34, 34') is arranged to be substantially perpendicular to the piston rod (33, 33') and has a radial size substantially corresponding to the chamber radial size (i.e., chamber width). Thus, in cooperation with the inner wall of the chamber (31, 31'), each plunger (34, 34') defines a first sub-chamber (35, 35') on one side of the plunger (left side of the plunger in the embodiment of FIG. 1) and defines a second sub-chamber (36, 36') on the opposite side of the plunger (right side of the plunger in the embodiment of FIG. 1). During the operation of the fluid transfer system (100), the piston (32, 32') moves back and forth (see double arrow (A, A')), thereby causing the total volume of the first sub-chamber (35, 35') and the second sub-chamber (36, 36') to change alternately and continuously, and thus these sub-chambers are variable volume sub-chambers.For example, when the piston (32, 32') moves to the right in FIG. 1, the volume of the first sub-chamber (35, 35') increases, while the volume of the second sub-chamber (36, 36') decreases; conversely, when the piston (32, 32') moves to the left in FIG. 1, the volume of the second sub-chamber (36, 36') increases, while the volume of the first sub-chamber (35, 35') decreases. According to the embodiment illustrated in FIG. 1, a plunger (34, 34') is provided at the axial end of the piston rod (33, 33') (i.e., the axial end opposite the axial end connected to the drive unit (M). Alternatively, the plunger (34, 34') may be provided at a different location along the longitudinal extension of the piston rod (33, 33'), provided that the base walls (31a, 31b) of the chamber (31) and the base walls (31a', 31b') of the chamber (31') enable sealed axial movement of the piston rod (33, 33') (an example not shown in the drawing).

[0064] The fluid transfer system (100) of the present disclosure also includes a first inlet fluid circuit (40) and a second inlet fluid circuit (40'). In detail, the first inlet fluid circuit (40) fluidly communicates with a first supply station (10) and a first pump module (30), and similarly, the second inlet fluid circuit (40') fluidly communicates with a second supply station (10') and a second pump module (30'). The first inlet fluid circuit (40) includes an inlet fluid path that supplies a first fluid (contained in the first supply station (10)) to a first variable volume sub-chamber (35) and a second variable volume sub-chamber (36), so that the chamber (31) is filled with an appropriate volume of the first fluid to be transferred (arrow (B)) outside the fluid transfer system (100). Similarly, the second inlet fluid circuit (40') includes an inlet fluid path that supplies the second fluid (contained in the second supply station (10')) to the first variable volume sub-chamber (35') and the second variable volume sub-chamber (36'), so that the chamber (31') is filled with an appropriate volume of the second fluid to be delivered (arrow (B')) outside the fluid delivery system (100).

[0065] In detail, the first and second inlet fluid circuits (40, 40') include a first inlet fluid path (41, 41') that fluidly communicates with a supply station (10, 10'), and the first inlet fluid path (41, 41') includes a supply station valve (11, 11') that enables each fluid to be discharged from the supply station (10, 10'). The supply station valve (11, 11') is an active valve operated by a fluid transfer system as described in detail in the following description.

[0066] Downstream of the supply station valve (11, 11'), the first and second inlet fluid circuits (40, 40') branch into a second inlet fluid path (42, 42') and a third inlet fluid path (43, 43'), which are fluidly communicating with the first sub-chamber (35, 35') and the second sub-chamber (36, 36'), respectively. The first sub-chamber (35, 35') is provided with a first inlet port (44, 44') that enables the second inlet fluid path (42, 42') to be fluidly communicating with the first sub-chamber (35, 35'). Similarly, the second sub-chamber (36, 36') is provided with a second inlet port (46, 46') that enables the third inlet fluid path (43, 43') to be fluidly communicating with the second sub-chamber (36, 36').

[0067] Upstream of the first inlet port (44, 44'), the second inlet fluid path (42, 42') is provided with a first inlet fluid circuit valve (45, 45') that allows each fluid (i.e., the first fluid exiting the first supply station (10) and the second fluid exiting the second supply station (10')) to flow into the first sub-chamber (35, 35') through the second inlet fluid path (42, 42'). According to one embodiment of the present invention, the first inlet fluid circuit valve (45, 45') is a check valve, i.e., a one-way valve, that allows the fluid to flow in only one direction, particularly from the supply station (10, 10') toward the first sub-chamber (35, 35'), and prevents the fluid from flowing back toward the supply station (10, 10').

[0068] Similarly, upstream of the second inlet port (46, 46'), a third inlet fluid path (43, 43') is provided with a second inlet fluid circuit valve (47, 47') that allows fluid to flow into the second sub-chamber (36, 36') through the third inlet fluid path (43, 43'). According to one embodiment of the present invention, the second inlet fluid circuit valve (47, 47') is a check valve, i.e., a one-way valve, that prevents the fluid from flowing back toward the supply station (10, 10') by allowing the fluid to flow in only one direction, particularly from the supply station (10, 10') toward the second sub-chamber (36, 36').

[0069] Preferably, the first and second inlet fluid circuit valves (45, 45' and 47, 47') are ball check valves in which a ball is present inside the body valve to control fluid flow.

[0070] The fluid transfer system (100) of the present disclosure also includes a first outlet fluid circuit (50) (separated from the first inlet fluid circuit (40)) and a second outlet fluid circuit (50') (separated from the second inlet fluid circuit (40'). In detail, the first outlet fluid circuit (50) is fluidly connected to the first pump module (30), and similarly, the second outlet fluid circuit (50') is fluidly connected to the second pump module (30'). Both the first and second outlet fluid circuits (50, 50') include a first outlet fluid path (51, 51') and a second outlet fluid path (52, 52') that enable the fluid transfer system (100) to discharge a first fluid from the chamber (31) (see arrow (B)) and discharge a second fluid from the chamber (31'), respectively (see arrow (B')). In detail, the first sub-chamber (35, 35') is provided with a first outlet port (53, 53') that allows a first outlet fluid path (51, 51') to fluidly communicate with the first sub-chamber (35, 35'). Similarly, the second sub-chamber (36, 36') is provided with a second outlet port (54, 54') that allows a second outlet fluid path (52, 52') to fluidly communicate with the second sub-chamber (36, 36'). As described in detail below in the present disclosure, when operated, the first outlet fluid path (51, 51') and the second outlet fluid path (52, 52') of the first outlet fluid circuit (50) and the second outlet fluid circuit (50') alternately discharge the first fluid from the first sub-chamber (35) and the second sub-chamber (36), and alternately discharge the second fluid from the first sub-chamber (35') and the second sub-chamber (36').

[0071] Downstream of the first outlet port (53, 53'), the first outlet fluid path (51, 51') is provided with a first outlet fluid circuit valve (55, 55') that allows the first and second fluids to be discharged from the first sub-chamber (35, 35') through the first outlet fluid path (51, 51'), respectively. According to an embodiment of the present disclosure, the first outlet fluid circuit valve (55, 55') is a check valve, i.e., a one-way valve, that prevents the fluid from flowing back into the first sub-chamber (35, 35') by allowing the fluid to flow in only one direction, particularly out of the first sub-chamber (35, 35').

[0072] Similarly, downstream of the second outlet port (54, 54'), the second outlet fluid path (52, 52') is provided with a second outlet fluid circuit valve (56, 56') that allows the first and second fluids to be discharged from the second sub-chamber (36, 36') through the second outlet fluid path (52, 52'), respectively. According to an embodiment of the present disclosure, the second outlet fluid circuit valve (56, 56') is a check valve, i.e., a one-way valve, that prevents the fluid from flowing back into the second sub-chamber (36, 36') by allowing the fluid to flow in only one direction, particularly out of the second sub-chamber (36, 36').

[0073] Preferably, the first outlet fluid circuit valve (55, 55') and the second outlet fluid circuit valve (56, 56') are spring-loaded check valves in which a spring component is used to support valve operation by eliminating the action of gravity on the check valve function. More preferably, the first outlet fluid circuit valve (55, 55') and the second outlet fluid circuit valve (56, 56') are spring-loaded ball check valves.

[0074] According to the embodiment illustrated in FIG. 1, the fluid transfer system (100) of the present disclosure further comprises a first recirculating fluid circuit (60) and a second recirculating fluid circuit (60'), and said recirculating fluid circuits are also designated in this description as additional fluid circuits (i.e., additional fluid circuits for the inlet and outlet fluid circuits mentioned above). Specifically, the first recirculating fluid circuit (60) fluid-fluidly connects the first and second variable volume subchambers (35, 36) of the chamber (31) of the first pump module (30), and said first recirculating fluid circuit (60) cooperates with a first actuator (70) (owned by said first recirculating fluid circuit (60)) to manage the passage of the first fluid in both directions between said first and second variable volume subchambers (35, 36). Similarly, the second recirculating fluid circuit (60') fluidically connects the first and second variable volume subchambers (35', 36') of the chamber (31') of the second pump module (30'), and the second recirculating fluid circuit (60') cooperates with a second actuator (70') (owned by the second recirculating fluid circuit (60')) to manage the passage of the second fluid in both directions between the first and second variable volume subchambers (35', 36').

[0075] According to the embodiment illustrated in FIG. 1, the first and second recirculating fluid circuits (60, 60') are located outside the chamber (31, 31') and fluidly connect the individual branches of the first and second inlet fluid circuits (40, 40') upstream of the inlet ports (44, 44' and 46, 46') of each sub-chamber (35, 35' and 36, 36'). In detail, with respect to the first pump module (30), the first axial end (61) of the first recirculating fluid circuit (60) is fluidly connected to the second inlet fluid path (42) of the first inlet fluid circuit (40) downstream of the first inlet fluid circuit valve (45), and the second axial end (62) of the first recirculating fluid circuit (60) is fluidly connected to the third inlet fluid path (43) of the first inlet fluid circuit (40) downstream of the second inlet fluid circuit valve (47). Similarly, with respect to the second pump module (30'), the first axial end (61') of the second recirculating fluid circuit (60') is fluidically connected to the second inlet fluid path (42') of the second inlet fluid circuit (40') downstream of the first inlet fluid circuit valve (45'), and the second axial end (62') of the second recirculating fluid circuit (60') is fluidly connected to the third inlet fluid path (43') of the second inlet fluid circuit (40') downstream of the second inlet fluid circuit valve (47').

[0076] The first and second actuators (70, 70') are active valves operated by the fluid transfer system (100) as described in detail below in this description. Preferably, the first and second actuators (70, 70') are electromechanical actuated valves that are automatically controlled and operated by a processor or control unit (P) of the fluid transfer system (100). As schematically illustrated in the drawing, the processor (P) controls and operates the first and second actuators (70, 70'), the actuating unit (M), and the first and second supply station valves (11, 11').

[0077] According to an alternative embodiment illustrated in FIG. 2, a fluid transfer system (100') is schematically illustrated in which the two pump modules (30, 30') are arranged in series rather than in parallel as illustrated in the embodiment of FIG. 1. In this alternative embodiment, the two chambers (31, 31') are separated and spaced apart from each other, while a common piston rod (33) having two spaced plungers (34, 34') is provided within the chambers (31, 31'), thereby defining the respective first variable volume sub-chamber and second variable volume sub-chamber (35, 35' and 36, 36'). All remaining components (and their operation) of the alternative embodiment are identical to each component of the fluid transfer system (100) illustrated in FIG. 1 and are therefore indicated by the same reference numerals.

[0078] An alternative arrangement for the embodiment of FIG. 2 is schematically illustrated in FIG. 3, wherein the fluid transfer system (100) comprises two pump modules (30, 30') having two chambers (31, 31') that share a common base wall (31c), arranged in series (similar to the embodiment of FIG. 2). Specifically, the two chambers (31, 31') are arranged consecutively along their common longitudinal axis and are adjacent to each other through the common base wall (31c). According to this embodiment, a common piston rod (33) having two spaced plungers (34, 34') is provided within the chambers (31, 31') to define the respective first variable volume subchamber (35, 35') and second variable volume subchamber (36, 36'). All remaining components (and their operation) of this alternative embodiment are of the fluid transfer system (100') illustrated in FIG. 2 It is identical to each component and is therefore indicated by the same reference number.

[0079] According to an alternative embodiment illustrated in FIG. 4, the fluid delivery system (200) includes a recirculation circuit (260, 260') and an actuator (270, 270') located inside each chamber (31, 31') for each pump module (30, 30'). In particular, the recirculation circuit (260, 260') and the actuator (270, 270') are integral with the plunger (34, 34') of the piston (32, 32'). That is, the recirculation circuit and the actuator are integrated into the plunger component. More specifically, the recirculation circuit (260, 260') includes a fluid passage obtained within the plunger thickness portion to ensure fluid communication between each sub-chamber (35, 36 and 35', 36'). In other words, the recirculation circuit (260, 260') is a duct (through hole) provided inside the plunger, and the diameter (radial size) of the duct is significantly smaller than the size (length) of the plunger. According to the alternative embodiment shown in FIG. 4, the actuator (270, 270') is placed inside the recirculation circuit (260, 260') and is automatically controlled and operated by the processor (P) of the fluid delivery system (200). Again, all remaining components (and their operation) of this alternative embodiment are identical to each component of the fluid delivery system (100) shown in FIG. 1 and are therefore indicated by the same reference numbers.

[0080] According to an alternative embodiment illustrated in FIG. 5, the fluid transfer system (200') combines the main technical features of the fluid transfer system (100') illustrated in FIG. 2 with the main technical features of the fluid transfer system (200) illustrated in FIG. 4. Specifically, the fluid transfer system (200') comprises two pump modules (30, 30') arranged in series (each chamber (31, 31') being spaced apart from each other), and each pump module (30, 30') is provided with a recirculation circuit (260, 260') and an actuator (270, 270') located inside each chamber (31, 31'). The configuration shown in FIG. 5 is also applicable to a fluid transfer system (not shown in the drawing) that combines the main technical features of the fluid transfer system (100) shown in FIG. 3 (two chambers (31, 31') arranged continuously along a common longitudinal axis and adjacent to each other through a common base wall (31c)) with the main technical features of the fluid transfer system (200) of FIG. 5.

[0081] According to an alternative embodiment illustrated in FIG. 6, the first outlet fluid circuit (50) and the second outlet fluid circuit (50') of the fluid delivery system (300) have a common output (see arrow (B)) for delivering the first fluid (exiting from the first pump module (30)) and the second fluid (exiting from the second pump module (30')). This technical solution is particularly advantageous, for example, when the first and second fluids must be mixed precisely before delivery (e.g., when the first and second fluids are components of a given adhesive or coating formulation and must not be mixed in advance but must be combined immediately before delivery and continuous application). All remaining components (and their operation) of this alternative embodiment are identical to each component of the fluid delivery system (100') illustrated in FIG. 2 and are therefore indicated by the same reference numerals.

[0082] According to an alternative embodiment illustrated in FIG. 7, the pressurizing unit (20) of the fluid transfer system (400) comprises two separate drive units (M, M') such that each pump module (30, 30') is actuated by a dedicated drive unit (i.e., drive unit (M) acts on the piston (32) of the first pump module (30), and drive unit (M') acts on the piston (32') of the second pump module (30'). The operation of the fluid transfer system according to this embodiment is particularly efficient in terms of fluid flow control and the accuracy of transferring a desired fluid volume. In fact, a fluid transfer system comprising a single drive unit inevitably displaces a variable volume of sub-chambers within two chambers (31, 31') at the same flow rate. In some applications, for example, when mixing of two fluids (a first fluid processed by a first pump module (30) and a second fluid processed by a second pump module (30'), said first fluid being different from said second fluid) is required, especially when the mixing is required at a ratio different from 50 / 50% (i.e., 50% of the first fluid and 50% of the second fluid), this aspect is difficult to manage and control. For example, if a 30 / 70% mixing ratio (i.e., a mixture of 30% of the first fluid and 70% of the second fluid) is required to be delivered by the fluid delivery system (400), the actuators (70, 70') of the respective first and second recirculating fluid circuits (60, 60') are closed, and the speeds of the pistons (32, 32') can be set to different values ​​to properly achieve the desired 30 / 70% mixing ratio (a fact made possible because each piston is operated independently by a separate independent drive unit).It may be emphasized that, even in the case of an embodiment in which the fluid delivery system includes two separate drive units, it is particularly advantageous to provide a recirculating fluid circuit to each of the two pump modules, because the recirculating fluid circuits ensure proper and continuous recirculation of each single fluid within each pump module (i.e., the first fluid is continuously recirculated within the first pump module (30), and the second fluid is continuously recirculated within the second pump module (30'), and the said recirculation contributes to keeping the fluids (i.e., each single fluid) continuously moving, mixing, and shaking before delivery.

[0083] According to another alternative embodiment illustrated in FIG. 8, the fluid transfer system (500) includes a first additional supply station (510) that fluidly communicates with the first pump module (30) at the supply station (10). Similar to the embodiment illustrated in FIG. 2, the first inlet fluid circuit (40) includes an additional first inlet fluid path (541) that fluidly connects the first additional supply station (510) to the second inlet fluid path (42) of the first inlet fluid circuit (40). Additionally, the additional first inlet fluid path (541) includes an additional supply station valve (511) that allows fluid to be discharged from the first additional supply station (510). The additional supply station valve (511) is an active valve operated by the fluid transfer system (500) as described in detail below in this description.

[0084] According to another embodiment (not shown in the drawing), the fluid transfer system (500) includes a second additional supply station that fluidly communicates with the second pump module (30').

[0085] According to another embodiment (not shown in the drawings), a first additional supply station (510) fluidly communicating with the first pump module (30) and / or a second additional supply station fluidly communicating with the second pump module (30') is provided in any of the disclosed embodiments of the fluid transfer system according to the present disclosure (e.g., the fluid transfer system (100) of FIG. 1, the fluid transfer system (100) of FIG. 3, the fluid transfer system (200) of FIG. 4, the fluid transfer system (200') of FIG. 5, and the fluid transfer system (300) of FIG. 6).

[0086] In the first embodiment, an additional supply station fluidly connected to a given pump module receives the same fluid stored in the supply station of the pump module. Accordingly, this additional supply station is conceived to provide a backup solution to the fluid delivery system in the event that the supply station malfunctions, or to provide a fluid replenishment source to increase the autonomy of the fluid delivery system and ensure fluid delivery continuity when the fluid in the supply station is depleted.

[0087] In a second embodiment, an additional supply station fluidically connected to a given pump module receives a fluid different from the fluid received in the supply station of the pump module. For example, the fluid received in the supply station is a high-concentration contrast agent (e.g., ISOVUE®-370), while the fluid received in the additional supply station is saline. This solution is particularly advantageous because, by appropriately mixing the high-concentration contrast agent with saline, the fluid delivery system can provide volumes of contrast agents of various concentrations, starting from a single type of high-concentration contrast agent. A mixing step to reach the desired concentration of the contrast agent to be delivered for a given patient and / or a given medical (diagnostic or therapeutic) application will be described in detail below in this description.

[0088] The operation of the delivery system according to the present disclosure will be illustrated below in relation to the above-described embodiments and in relation to applications related to the medical field, more specifically, the alternating or simultaneous injection of contrast agents and saline solutions for diagnostic purposes. However, as already mentioned above in this specification, the delivery system according to the present disclosure may be used in other technical fields unrelated to medical / healthcare applications. Furthermore, the general operating principle (described below with reference to some embodiments of the delivery system of the present disclosure) is applicable to a plurality of embodiments disclosed in this specification and / or illustrated in the drawings related thereto.

[0089] As a first example of a method for operating a transmission system according to the present disclosure, reference is made to FIG. 9 and FIG. 10, which illustrate a transmission system (100') according to an embodiment shown in FIG. 2.

[0090] The supply station (10) receives a first fluid (not shown), e.g., a contrast agent, required to be injected into the patient by the delivery system (100') (see arrow (B)), while the supply station (10') receives a second fluid (not shown), e.g., saline, required to be injected into the patient by the delivery system (100') (see arrow (B')). Generally, the first fluid exiting B and the second fluid exiting B' are transported to the patient through a common pipe (patient line - not shown) that is mechanically and fluidly connected to a catheter and / or a needle for accessing the patient's vascular system.

[0091] As a first initiation step, the delivery method according to the present disclosure comprises the step of filling the first and second sub-chambers (35, 36) of the first pump module (30) with a first fluid, and similarly, the step of filling the first and second sub-chambers (35', 36') of the second pump module (30') with a second fluid. To perform the filling step, the processor (P) opens the supply station valve (11, 11'), closes the actuators (70, 70') of the first and second recirculating fluid circuits (60, 60'), and acts on the drive unit (M) to reciprocate the common piston (32) within the chamber (31, 31'), thereby causing the first and second fluids to exit the supply station (10, 10'), respectively, and flow through the first inlet fluid circuit (40) and the second inlet fluid circuit (40'). In detail, as soon as the piston (32) is translated axially along the first direction (e.g., arrow (C) in FIG. 9), under-pressure is generated within the first sub-chamber (e.g., sub-chamber (35, 35')) whose volume increases due to the piston's axial movement. Accordingly, each fluid flows through the first and second inlet fluid paths (41, 41' and 42, 42') of the first and second inlet fluid circuits (40, 40'), then through the corresponding first inlet fluid circuit valve (e.g., first inlet fluid circuit valve (45, 45')), and then enters the first sub-chamber to fill. At the same time, the air contained in the second sub-chamber (e.g., sub-chamber (36, 36')) (volume reduction due to piston axial movement (arrow (C))) is primed in the fluid delivery system through an exhaust means owned by the opposite second inlet fluid circuit valve (e.g., second inlet fluid circuit valve (47, 47')).In fact, the air contained within the first sub-chamber (35, 35') is generally forced to pass through the first inlet port (44, 44'), then through the second inlet fluid path (42, 42'), and finally through the first inlet fluid circuit valve (45, 45') to exit the sub-chamber. Subsequently, in order to fill the second sub-chamber with the respective fluid and to prime the first sub-chamber (i.e., to release air from it), the processor (P) acts on the drive unit (M) to reverse the piston movement so that the piston translates axially along a second direction opposite to the first direction (e.g., arrow (D) in FIG. 10). Since the actuator (70, 70') remains closed while the piston moves during the charging and priming phase, underpressure is generated within the second sub-chamber (e.g., sub-chamber (36, 36')) whose volume increases due to the piston's axial movement (arrow (D)). Accordingly, the first and second fluids flow through the first inlet fluid path (41, 41') and the third inlet fluid path (43, 43') of the first and second inlet fluid circuits (40, 40'), respectively, through the corresponding second inlet fluid circuit valve (e.g., second inlet fluid circuit valve (47, 47')), and then enter the second sub-chamber to charge. At the same time, air still contained within the first sub-chamber (e.g., sub-chamber (35, 35')) (volume reduction due to piston axial movement (arrow (D))) is primed from the fluid delivery system through an exhaust means possessed by the corresponding first inlet fluid circuit valve (e.g., first inlet fluid circuit valve (45, 45')). In fact, air contained within the second sub-chamber (36, 36') is generally forced to exit the sub-chamber by passing through the second inlet port (46, 46'), then through the third inlet fluid path (43, 43'), and finally through the second inlet fluid circuit valve (47, 47').During the priming step, a portion of the first fluid and the second fluid exits the fluid transfer system through the first and second outlet fluid circuits (50, 50'), so that the priming of the first and second outlet fluid circuits (50, 50') can also be properly performed.

[0092] Alternatively, air priming of the fluid delivery system is performed by a dedicated exhaust means (not shown in the drawing) separate from the fluid circuit valve. According to an alternative embodiment, the dedicated exhaust means is coupled to each valve of the fluid delivery system. According to another alternative embodiment, the dedicated exhaust means is coupled to each actuator (70, 70') of the first and second recirculating fluid circuits (60, 60').

[0093] As soon as the chambers (31, 31') are filled with the first and second fluids, respectively, and the priming of the fluid delivery system is completed, the processor (P) closes the supply station valve (11, 11') and opens the actuators (70, 70') of the first and second recirculating fluid circuits (60, 60'), while the drive unit (M) remains operated to maintain the piston (32) axially translational movement (arrows (C and D)) within the chambers (31, 31'). Alternatively, when the two fluids are recirculated inside the respective chambers (31, 31'), the processor (P) opens the actuators (70, 70') of the first and second recirculating fluid circuits (60, 60') while the supply station valve (11, 11') remains in an open operating state.

[0094] By keeping the actuators (70, 70') of the first and second recirculating fluid circuits (60, 60') in an open operating state, the fluid delivery system (100') is prevented from delivering the first and second fluids to the outside. In fact, thanks to the open operating state of the actuators (70, 70') and the axial translation of the piston (32), the first fluid is continuously recirculated within the first chamber (31) through the first recirculating fluid circuit (60), while the second fluid is continuously recirculated within the second chamber (31') through the second recirculating fluid circuit (60'). Specifically, when the piston (32) moves in the first direction (e.g., arrow (C) in FIG. 9), the first fluid contained in the second sub-chamber (36) is pushed out through the second inlet port (46) and then enters the first sub-chamber (35) from the first inlet port (44) through the first recirculating fluid circuit (60) and the first actuator (70). At the same time, the second fluid contained in the second sub-chamber (36') is pushed out through the second inlet port (46') and then enters the first sub-chamber (35') from the first inlet port (44') through the second recirculating fluid circuit (60') and the second actuator (70').

[0095] Then, when the piston (32) reaches the first end-stop, that is, when the plunger (34) completes axial translation in the first direction (right direction in FIG. 9 - see arrow (C)) and reaches the vicinity of the base wall (31a) of the chamber (31) and the plunger (34') reaches the vicinity of the base wall (31a') of the chamber (31'), the processor (P) acts on the drive unit (M) to reverse the piston's axial translation (left direction in FIG. 10 - see arrow (D)). Similar to the first run of the piston described above, the first fluid contained in the first sub-chamber (35) is pushed out through the first inlet port (44) and then enters the second sub-chamber (36) through the first recirculating fluid circuit (60) and the first actuator (70) at the second inlet port (46). At the same time, the second fluid contained in the first sub-chamber (35') is pushed out through the first inlet (44') and then enters the second sub-chamber (36') through the second recirculating fluid circuit (60') and through the second actuator (70') at the second inlet port (46').

[0096] Then, as soon as the piston (32) reaches the second end stop, that is, as soon as the plunger (34, 34') completes axial translation in the second direction (see left direction in FIG. 10 - arrow (D)) and reaches the vicinity of the base wall (31b, 31b') of each chamber (31, 31') (thus, the first sub-chamber (35, 35') accommodates each fluid of substantially small volume, while the second sub-chamber (36, 36') accommodates each fluid of large volume), the processor (P) acts on the drive unit (M) to reverse the piston axial translation again (see right direction in FIG. 9 - arrow (C)), thereby starting a new filling / discharging cycle of the chambers (31, 31') of the fluid delivery system (100'). Of course, any number of cycles can be configured, and said number depends on the requirements of the specific fluid to be delivered and the specific application where the fluid delivery system is implemented. As already mentioned above, the initial recirculation step of the two fluids within each chamber is particularly advantageous because it enables the two fluids to continue moving within the fluid delivery system, thereby ensuring proper and homogeneous agitation of each single fluid before delivery.

[0097] It should be noted that the fluid contained in the second sub-chamber (36, 36') and pushed by the plunger (34, 34') is not allowed to flow back to the supply station (10, 10') nor to access the second outlet fluid path (52, 52') of the first and second outlet fluid circuits (50, 50'). In practice, preferably, the supply station valve (11, 11') is closed, and the first and second inlet fluid circuit valves (45, 45' and 47, 47') are both unidirectional valves that allow fluid to flow from the supply station (10, 10') to their respective chambers (31, 31') but not vice versa, thereby preventing the fluid discharged from the first and second sub-chambers (35, 35' and 36, 36') from flowing back through the first and second inlet fluid paths (41, 41' and 42, 42') of the first and second inlet fluid circuits (40, 40'). Additionally, since the first and second outlet fluid circuit valves (55, 55' and 56, 56') are automatically opened only when the fluid discharged from the first and second sub-chambers (35, 35' and 36, 36'), respectively, has a pressure high enough to overcome the internal elasticity of the valves (preferably, the first and second outlet fluid circuit valves are ball spring-loaded check valves), when the actuator (70, 70') is in an open state, the fluid discharged from the first and second sub-chambers (35, 35' and 36, 36') does not have enough force to overcome the internal elasticity of the first and second outlet fluid circuit valves (55, 55' and 56, 56'), so the fluid is not delivered outside the fluid delivery system (100') but is recirculated inside each sub-chamber.

[0098] From the above, it is evident that the fluid transfer system of the present disclosure enables the continuous and predetermined movement (e.g., in terms of volume, piston translation speed) of one or both fluids before they exit the fluid transfer system. As already mentioned above, this aspect of the present disclosure is particularly advantageous when it is required that specific fluid characteristics (e.g., compositional homogeneity, temperature, viscosity, mixture, fluidity) be achieved and / or maintained before the transfer of the fluid begins. In practice, the fluid transfer system according to the present disclosure enables the fluid introduced into the first and second chambers (31, 31') to be continuously recirculated by alternately charging / discharging between the first and second sub-chambers (35, 35' and 36, 36') when the fluid transfer system (100') is not being transferred, that is, when the fluid is certainly not exiting the fluid transfer system. Thanks to the first and second recirculating fluid circuits (60, 60') and the first and second actuators (70, 70') coupled thereto, the recirculation and redistribution of fluid between the two sub-chambers contributes to balancing the internal pressure. This aspect is particularly advantageous because it enables the system to operate at a limited (low) pressure at least in the initial stage when the delivery system is not yet delivering fluid to the outside of the system, thereby limiting the technical constraints that would need to be implemented if the system were required to operate at high pressure values.

[0099] As soon as recirculation is completed (e.g., successfully reaching the desired homogeneity of one fluid or both fluids, and at a certain point, the delivery of the first fluid and / or the second fluid is required to begin), the processor (P) appropriately acts on the first or second actuator (70, 70') to close the first or second actuator (70, 70') and stop the recirculation step of at least one of the first and second fluids.

[0100] For example, when it is required that the first fluid contained within the supply station (10) be delivered first, the processor (P) closes the first actuator (70) of the first recirculating fluid circuit (60), while the second actuator (70') of the second recirculating fluid circuit (60') remains open and operational so that the delivery of the first fluid (arrow (B)) can be performed, while the second fluid continues to be recirculated within the individual chamber (31'). This is a case where, for example, at a given time of an injection / infusion process performed on a given patient undergoing an examination procedure (e.g., CT diagnostic examination), the fluid delivery system (100') is required to deliver only the first fluid (e.g., contrast agent) contained within the supply station (10), while the recirculation of the second fluid (e.g., saline) is performed (i.e., the second fluid is not delivered outside the fluid delivery system at that time).

[0101] Accordingly, the delivery method according to the present disclosure includes the step of initiating the delivery of a first fluid contained within a first chamber (31) (i.e., delivery to the outside of the fluid delivery system). To perform the step, as mentioned above, the processor (P) closes the first actuator (70) of the first recirculating fluid circuit (60) and opens the first supply station valve (11). During the delivery of the first fluid (the fluid exiting the fluid delivery system—see arrow (B)), the first supply station valve (11) is kept open, because it is important to refill the sub-chambers (35, 36) of the first chamber (31) with new fluid to avoid fluid disturbances that could affect the proper functioning of the piston and consequently the entire fluid delivery system. When the first actuator (70) is closed, the first fluid is prevented from flowing through the first recirculating fluid circuit (60) (at the same time, as already mentioned above, the first and second inlet fluid circuit valves (45, 47) do not allow backflow of the first fluid toward the first supply station (10)), so when the first plunger (34) is pushed in the first direction (arrow (C) in FIG. 9) and then in the second opposite direction (arrow (D) in FIG. 10), the first fluid is made to exit through the second outlet port (54) and the first outlet port (53) of the first chamber (31), respectively. Therefore, when the first fluid is pushed to pass through the second outlet port (54) (arrow (C)), the first fluid flows into the second outlet fluid path (52) of the first outlet fluid circuit (50) and then passes through the second outlet fluid circuit valve (56), because at this stage of the procedure, the first actuator (70) is closed, so the fluid pressure is high enough to overcome the internal elasticity of the second outlet fluid circuit valve (56).Similarly, when the first fluid is pushed through the first outlet port (53) (arrow (D)), the first fluid flows into the first outlet fluid path (51) of the outlet fluid circuit (50) and then passes through the first outlet fluid circuit valve (55), because at this stage of the procedure, the first actuator (70) is closed, so the fluid pressure is high enough to overcome the internal elasticity of the first outlet fluid circuit valve (55). Consequently, the first fluid is finally delivered by sequentially discharging the first fluid from the first and second sub-chambers (35, 36) of the first chamber (31) (arrow (B)). In fact, since the first and second outlet fluid circuit valves (55, 56) are unidirectional valves, the first fluid cannot flow back through the underpressurized path and is inevitably forced to be delivered (arrow (B)).

[0102] It may be noted that the delivery method according to the present disclosure does not necessarily require that the sub-chambers (35, 36) be completely filled with the first fluid or that the first fluid be completely discharged. In other words, it is not necessary for the first plunger (34) to reach the base walls (31a, 31b) of the first chamber (31) during the forward and backward axial translation of the first plunger (34). This means that the delivery method according to the present disclosure may include a partial filling / discharging step of the first fluid into / from each sub-chamber of the first chamber, particularly where it is required that a defined (and generally small) volume of the first fluid be delivered in a single injection (i.e., along a single translation of the first plunger without inversion). Of course, this aspect mentioned above may similarly apply to the sub-chambers (35', 36') of the second chamber (31').

[0103] As described above, during the step of delivering the first fluid (arrow (B)), the first supply station valve (11) is kept open so that new first fluid can alternately enter the two sub-chambers of the first chamber, and no unwanted disturbance will occur while the piston is axially translated within the first chamber (31). It may be noted that the new first fluid entering the system during the delivery step is not immediately delivered even if it does not pass through the first actuator (70) and the first recirculating fluid circuit (60). In fact, the new first fluid enters the underpressurized sub-chamber, while the first fluid delivered by the system is the fluid contained within the pressurized sub-chamber. Thus, before delivery, the new first fluid is constantly moving and mixing within each sub-chamber due to the piston's axial translation, thereby ensuring that the desired delivery conditions are reached before it finally exits the system.

[0104] As previously mentioned above, the applicant has discovered that by allowing the first fluid to flow through the first recirculating fluid circuit (60) and the first actuator (70) coupled thereto, the recirculation of the first fluid within the first chamber (31) can significantly reduce or even completely eliminate the risk of pressure pulsation, particularly at the beginning of the fluid delivery process, when the first fluid is delivered. In fact, the fluid delivery system according to the present disclosure can appropriately control the pressure drop or pressure spike that occurs when the piston (32) begins to move thanks to the presence of the first recirculating fluid circuit (60) and the first actuator (70). In fact, according to the present disclosure, the fluid delivery system begins to deliver the first fluid (outside the fluid delivery system) when the first fluid recirculation inside the first chamber (31) has already started, so the delivery will begin when the piston is already moving inside the first chamber (31). This clearly means that the start of fluid transfer is not simultaneous with the start of piston movement, because the transfer of the first fluid begins when the piston is already axially translated within the first chamber (31) to enable the first fluid recirculation step to be performed.

[0105] Additionally, as already mentioned above, the applicant has also discovered that by allowing the first fluid to flow through the first recirculation fluid circuit (60) and the first actuator (70) coupled thereto, the recirculation of the first fluid within the first chamber (31) can significantly reduce or even completely eliminate the waiting time of the fluid delivery system. Waiting time is the technical time inevitably required for the fluid delivery system to prepare to deliver fluid. In fact, as soon as the processor (P) instructs the drive unit (M) to deliver current, the current generally forms an electromagnetic field acting on the rotor magnet, which generates torque on the gear, causing the piston to start moving. Once the piston starts moving, the fluid pressure begins to increase, and some additional time is still required to reach and overcome the pressure threshold set for the first and second outlet fluid circuit valves (55, 56). The sum of all these times is called the "waiting time," and since it is not at a negligible level, it inevitably causes a delay in fluid delivery to the outside of the fluid delivery system. Thanks to the presence of the first recirculating fluid circuit (60) and the first actuator (70) coupled thereto, the fluid delivery system (100') of the present disclosure can overcome or reduce the waiting time because the piston (32) begins to move appropriately prior to fluid delivery to perform the recirculation of the first fluid within the first chamber (31). Thus, as soon as the processor (P) closes the first actuator (70) to start the delivery of the first fluid (arrow (B)), the fluid pressure immediately increases and very quickly exceeds the pressure threshold set for the first and second outlet fluid circuit valves (55, 56). Consequently, the first fluid is delivered by the system immediately after the processor (P) commands the delivery to begin.

[0106] As soon as the delivery of the first fluid (e.g., contrast agent) contained in the first supply station (10) is required to end and the delivery of the second fluid (e.g., saline solution) contained in the second supply station (10') is required to begin, the processor (P) opens the first actuator (70) of the first recirculating fluid circuit (60) and closes the second actuator (70') of the second recirculating fluid circuit (60') so that the delivery of the second fluid (arrow (B')) is performed while the first fluid is recirculated inside each chamber (31).

[0107] Accordingly, the delivery method according to the present disclosure further comprises the step of initiating the delivery of the second fluid contained within the second chamber (31') (i.e., delivery to the outside of the fluid delivery system). To perform the step, as mentioned above, the processor (P) closes the second actuator (70') of the second recirculating fluid circuit (60') and opens the second supply station valve (11'). During the delivery of the second fluid (the fluid exiting the delivery system—see arrow (B')), the second supply station valve (11') is kept open, because it is important to refill the sub-chambers (35', 36') of the second chamber (31') with new second fluid to avoid fluid disturbances that could affect the proper functioning of the piston and consequently the entire fluid delivery system. When the second actuator (70') is closed, the second fluid is prevented from flowing through the second recirculating fluid circuit (60') (at the same time, as already mentioned above, the first and second inlet fluid circuit valves (45', 47') do not allow backflow of the second fluid toward the second supply station (10'), so when the second plunger (34') is pushed in the first direction (arrow (C) in FIG. 9) and the second opposite direction (arrow (D) in FIG. 10), the second fluid is made to exit through the second outlet port (54') and the first outlet port (53) of the second chamber (31'), respectively. Therefore, when the second fluid is pushed to pass through the second outlet port (54') (arrow (C)), the second fluid flows into the second outlet fluid path (52') of the second outlet fluid circuit (50') and then passes through the second outlet fluid circuit valve (56'), because the second actuator (70') is closed at this stage of the procedure, so the fluid pressure is high enough to overcome the internal elasticity of the second outlet fluid circuit valve (56').Similarly, when the second fluid is pushed through the first outlet port (53') (arrow (D)), the second fluid flows into the first outlet fluid path (51') of the second outlet fluid circuit (50') and then passes through the first outlet fluid circuit valve (55'), because the second actuator (70') is closed at this stage of the procedure, so the fluid pressure is high enough to overcome the internal elasticity of the first outlet fluid circuit valve (55'). Consequently, the second fluid is finally delivered by sequentially discharging the second fluid from the first and second sub-chambers (35', 36') of the second chamber (31') (arrow (B')). In fact, since the first and second outlet fluid circuit valves (55', 56') are unidirectional valves, the second fluid cannot flow back through the underpressurized path and is inevitably forced to be delivered (arrow (B')).

[0108] The operation of the alternative delivery system (200') illustrated in FIG. 5 is disclosed in detail below with reference to FIG. 11 and FIG. 12, and said operation is substantially the same as the method steps disclosed above with reference to the fluid delivery system (100') of FIG. 2.

[0109] As a first disclosure step, the delivery method according to the present disclosure includes the step of filling the first and second sub-chambers (35, 36) of the first pump module (30) with a first fluid, and similarly, the step of filling the first and second sub-chambers (35', 36') of the second pump module (30') with a second fluid. To perform the above charging step, the processor (P) opens the first and second supply station valves (11, 11'), closes the first and second actuators (270, 270') of the first and second recirculating fluid circuits (260, 260'), and acts on the drive unit (M) to move the common piston (32) within the first and second chambers (31, 31'), thereby causing the first and second fluids to flow out of the first and second supply stations (10, 10'), respectively, and through the first and second inlet fluid circuits (40, 40'). In detail, as soon as the piston (32) is translated axially along the first direction (e.g., arrow (C) in FIG. 11), a low pressure is generated within the first sub-chamber (e.g., sub-chamber (35, 35')), where the volume increases due to the axial movement of the piston. Accordingly, each fluid flows through the first and second inlet fluid paths (41, 41' and 42, 42') of the first and second inlet fluid circuits (40, 40'), then through the corresponding first inlet fluid circuit valve (e.g., first inlet fluid circuit valve (45, 45')), and then enters and fills the first sub-chamber (35, 35'). At the same time, the air contained in the second sub-chamber (e.g., sub-chamber (36, 36')) (volume reduction due to piston axial movement (arrow (C))) is primed from the fluid delivery system through an exhaust means possessed by the opposite second inlet fluid circuit valve (e.g., second inlet fluid circuit valve (47, 47')).In fact, the air contained in the second sub-chamber (36, 36') is generally forced to pass through the second inlet port (46, 46'), then through the third inlet fluid path (43, 43'), and finally through the second inlet fluid circuit valve (47, 47') to exit the sub-chamber. Subsequently, in order to fill the second sub-chamber with the respective fluid and to prime the first sub-chamber (i.e., to release air from it), the processor (P) acts on the drive unit (M) to reverse the piston movement so that the piston translates axially along a second direction opposite to the first direction (e.g., arrow (D) in FIG. 12). Since the first and second actuators (270, 270') remain closed while the piston moves during the filling and priming phase, underpressure is generated within the second sub-chamber (e.g., sub-chamber (36, 36')) whose volume increases due to the piston's axial movement (arrow (D)). Accordingly, the first and second fluids flow through the first inlet fluid path (41, 41') and the third inlet fluid path (43, 43') of the first and second inlet fluid circuits (40, 40'), respectively, through the corresponding second inlet fluid circuit valve (e.g., second inlet fluid circuit valve (47, 47')), and then enter the second sub-chamber (36, 36') to fill. At the same time, the air still contained within the first sub-chamber (e.g., sub-chamber (35, 35')) (volume reduced due to piston axial movement (arrow (D))) is primed in the fluid delivery system through an exhaust means owned by the corresponding first inlet fluid circuit valve (e.g., first inlet fluid circuit valve (45, 45')).In fact, the air contained in the first sub-chamber (35, 35') is generally forced to pass through the first inlet port (44, 44'), then through the second inlet fluid path (42, 42'), and finally through the first inlet fluid circuit valve (45, 45') to exit the sub-chamber. During the priming step, a portion of the first fluid and the second fluid may exit the delivery system through the first and second outlet fluid circuits (50, 50'), and priming of the first and second outlet fluid circuits (50, 50') may also be performed.

[0110] Alternatively, air priming of the fluid delivery system is performed by a dedicated exhaust means (not shown in the drawing) separate from the fluid circuit valve. According to an alternative embodiment, the dedicated exhaust means is coupled to each valve of the fluid delivery system. According to another alternative embodiment, the dedicated exhaust means is coupled to each actuator (270, 270') of the first and second recirculating fluid circuits (260, 260').

[0111] As soon as the chambers (31, 31') are filled with the first fluid and the second fluid, respectively, and the priming of the delivery system is completed, the processor (P) closes the first and second supply station valves (11, 11') and opens the first and second actuators (270, 270') of the first and second recirculating fluid circuits (260, 260'), while the drive unit (M) is still operated to maintain the piston (32) axially translational movement (arrows (C and D)) within the first and second chambers (31, 31'). Alternatively, the processor (P) opens the first and second actuators (270, 270') of the first and second recirculation fluid circuits (260, 260') while the first and second supply station valves (11, 11') are kept open when the two fluids are recirculated inside their respective chambers (31, 31').

[0112] The first actuator (270) is designed to allow the first fluid (flowing through the first recirculating fluid circuit (260)) to move in a second direction opposite to the first direction (see arrow (E) in FIG. 11) when the piston (32) advances in the first direction (see arrow (C) in FIG. 11). Thus, the translational movement of the plunger (34) along the first direction 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), while the fluid initially contained in the second sub-chamber (36) passes through the first recirculating fluid circuit (260) and the first actuator (270) coupled thereto and enters the first sub-chamber (35).

[0113] Similarly, the second actuator (270') is designed to allow the second fluid (flowing through the second recirculating fluid circuit (260')) to move in a second direction opposite to the first direction (see arrow (E') in FIG. 11) when the piston (32) advances in the first direction (see arrow (C) in FIG. 11). Thus, the translational movement of the plunger (34') along the first direction 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'), while the fluid initially contained in the second sub-chamber (36') passes through the second recirculating fluid circuit (260') and the second actuator (270') coupled thereto and enters the first sub-chamber (35').

[0114] By keeping the first and second actuators (270, 270') of the first and second recirculating fluid circuits (260, 260') in an open operating state, the fluid delivery system (200') is prevented from delivering the first and second fluids to the outside. In fact, thanks to the open operating state of the first and second actuators (270, 270') and the axial translation of the piston (32), the first fluid is continuously recirculated within the first chamber (31) through the first recirculating fluid circuit (260), while the second fluid is continuously recirculated within the second chamber (31') through the second recirculating fluid circuit (260'). Specifically, when the piston (32) moves in the first direction (e.g., arrow (C) in FIG. 11), the first fluid contained in the second sub-chamber (36) is pushed out through the first recirculating fluid circuit (260) and the first actuator (270) and enters the first sub-chamber (35). At the same time, the second fluid contained in the second sub-chamber (36') is pushed out through the second recirculating fluid circuit (260') and the second actuator (270') and enters the first sub-chamber (35').

[0115] Then, when the piston (32) reaches the first end stop point, that is, when the plunger (34) completes the axial translation in the first direction (see right direction in FIG. 11 - arrow (C)) and reaches the vicinity of the base wall (31a) of the first chamber (31) and the plunger (34') reaches the vicinity of the base wall (31a') of the second chamber (31'), the processor (P) acts on the drive unit (M) to reverse the piston's axial translation (see left direction in FIG. 12 - arrow (D)). Similar to the first travel of the piston described above, the first fluid contained in the first sub-chamber (35) is pushed out through the first recirculating fluid circuit (260) and through the first actuator (270) (see arrow F in FIG. 12) and enters the second sub-chamber (36). At the same time, the second fluid contained in the first sub-chamber (35') is pushed out through the second recirculating fluid circuit (260') and through the second actuator (270') (see arrow F' in FIG. 12) and enters the second sub-chamber (36').

[0116] Then, as soon as the piston (32) reaches the second end stop, the plunger (34, 34') completes axial translation in the second direction (left direction in FIG. 12 - see arrow (D)) and reaches the vicinity of the base walls (31b, 31b') of each first and second chamber (31, 31') (thus, the first sub-chamber (35, 35') accommodates each fluid of substantially small volume, while the second sub-chamber (36, 36') accommodates each fluid of large volume), the processor (P) acts on the drive unit (M) to reverse the piston axial translation again (right direction in FIG. 11 - see arrow (C)), thereby starting a new filling / discharging cycle of the first and second chambers (31, 31') of the fluid delivery system (200'). Of course, any number of cycles can be configured, and said number depends on the requirements of the specific fluid to be delivered and the specific application where the delivery system is implemented. As already mentioned above, the initial recirculation step of the two fluids within each chamber is particularly advantageous because it ensures proper and homogeneous shaking of each single fluid before delivery by enabling the two fluids to continue moving within the fluid delivery system.

[0117] As soon as recirculation is completed (e.g., successfully reaching the desired homogeneity of one fluid or both fluids, and at a certain point, the delivery of the first fluid and / or the second fluid is required to begin), the processor (P) appropriately acts on the first or second actuator (270, 270') to close the first or second actuator (270, 270') and stop the recirculation step of at least one of the first and second fluids.

[0118] For example, when it is required that only the first fluid contained within the supply station (10) be delivered, the processor (P) closes the first actuator (270) of the first recirculating fluid circuit (260), while the second actuator (270') of the second recirculating fluid circuit (260') remains open, so that the delivery of the first fluid (arrow (B)) can be performed, while the second fluid continues to be recirculated within each second chamber (31'). This is a case where, for example, at a given time of an injection / infusion procedure performed on a given patient undergoing a medical examination (e.g., CT diagnostic examination), the delivery system (200') is required to deliver only the first fluid (e.g., contrast agent) contained within the supply station (10), while the recirculation of the second fluid (e.g., saline) is performed (i.e., the second fluid is not delivered outside the fluid delivery system at that particular time).

[0119] Accordingly, the delivery method according to the present disclosure includes the step of initiating the delivery of a first fluid contained within a first chamber (31) (i.e., delivery to the outside of the fluid delivery system). To perform the step, as mentioned above, the processor (P) closes the first actuator (270) of the first recirculating fluid circuit (260) and opens the first supply station valve (11). During the delivery of the first fluid (the fluid exiting the fluid delivery system—see arrow (B)), the first supply station valve (11) is kept open, because it is important to refill the sub-chambers (35, 36) of the first chamber (31) with new fluid to avoid fluid disturbances that could affect the proper functioning of the piston and consequently the entire fluid delivery system. When the first actuator (270) is closed, the first fluid is prevented from flowing through the first recirculating fluid circuit (260) (at the same time, as already mentioned above, the first and second inlet fluid circuit valves (45, 47) do not allow backflow of the first fluid toward the first supply station (10)), so when the first plunger (34) is pushed in the first direction (arrow (C) in FIG. 11) and then in the second opposite direction (arrow (D) in FIG. 12), the first fluid is made to exit through the second outlet port (54) and the first outlet port (53) of the first chamber (31), respectively. Accordingly, when the first fluid is pushed to pass through the second outlet port (54) (arrow (C)), the first fluid flows into the second outlet fluid path (52) of the first outlet fluid circuit (50) and then passes through the second outlet fluid circuit valve (56), because at this stage of the procedure, the first actuator (270) is closed, so the fluid pressure is high enough to overcome the internal elasticity of the second outlet fluid circuit valve (56).Similarly, when the first fluid is pushed through the first outlet port (53) (arrow (D)), the first fluid flows into the first outlet fluid path (51) of the outlet fluid circuit (50) and then passes through the first outlet fluid circuit valve (55), because at this stage of the procedure, the first actuator (270) is closed, so the fluid pressure is high enough to overcome the internal elasticity of the first outlet fluid circuit valve (55). Consequently, the first fluid is finally delivered by sequentially discharging the first fluid from the first and second sub-chambers (35, 36) of the first chamber (31) (arrow (B)). In fact, since the first and second outlet fluid circuit valves (55, 56) are unidirectional valves, the first fluid cannot flow back through the underpressurized path and is inevitably forced to be delivered (arrow (B)).

[0120] Similarly, as soon as the delivery of the first fluid (e.g., contrast agent) contained in the first supply station (10) is required to end and the delivery of the second fluid (e.g., saline solution) contained in the second supply station (10') is required to begin, the processor (P) opens the first actuator (270) of the first recirculating fluid circuit (260) and closes the second actuator (270') of the second recirculating fluid circuit (260') so that the delivery of the second fluid (arrow (B')) is performed while the first fluid is recirculated inside each first chamber (31).

[0121] Accordingly, the delivery method according to the present disclosure further comprises the step of initiating the delivery of the second fluid contained within the second chamber (31') (i.e., delivery to the outside of the fluid delivery system). To perform the step, as described above, the processor (P) closes the second actuator (270') of the second recirculating fluid circuit (260') and opens the second supply station valve (11'). During the delivery of the second fluid (the fluid exiting the delivery system—see arrow (B')), the second supply station valve (11') is kept open, because it is important to refill the sub-chambers (35', 36') of the second chamber (31') with new second fluid to avoid fluid disturbances that could affect the proper functioning of the piston and consequently the entire delivery system. When the second actuator (270') is closed, the second fluid is prevented from flowing through the second recirculating fluid circuit (260') (at the same time, as already mentioned above, the first and second inlet fluid circuit valves (45', 47') do not allow backflow of the second fluid toward the second supply station (10'), so when the second plunger (34') is pushed in the first direction (arrow (C) in FIG. 11) and the second opposite direction (arrow (D) in FIG. 12), the second fluid is made to exit through the second outlet port (54') and the first outlet port (53) of the second chamber (31'), respectively. Therefore, when the second fluid is pushed to pass through the second outlet port (54') (arrow (C)), the second fluid flows into the second outlet fluid path (52') of the second outlet fluid circuit (50') and then passes through the second outlet fluid circuit valve (56'), because the second actuator (270') is closed at this stage of the procedure, so the fluid pressure is high enough to overcome the internal elasticity of the second outlet fluid circuit valve (56').Similarly, when the second fluid is pushed through the first outlet port (53') (arrow (D)), the second fluid flows into the first outlet fluid path (51') of the second outlet fluid circuit (50') and then passes through the first outlet fluid circuit valve (55'), because the second actuator (270') is closed at this stage of the procedure, so the fluid pressure is high enough to overcome the internal elasticity of the first outlet fluid circuit valve (55'). Consequently, the second fluid is sequentially discharged from the first and second sub-chambers (35', 36') of the second chamber (31') and finally delivered (arrow (B')). In fact, since the first and second outlet fluid circuit valves (55', 56') are unidirectional valves, the second fluid cannot flow back through the underpressurized path and is forced to be delivered (arrow (B')).

[0122] According to the present disclosure, the step of mixing two different fluids and the step of delivering the obtained mixture of the two fluids are described below with reference to the fluid delivery system illustrated in FIG. 8 and FIG. 13.

[0123] Accordingly, according to the embodiment of FIG. 8, a first fluid (e.g., a contrast agent when the fluid delivery system (500) is applied in the medical field) is received in the first supply station (10), while a second fluid (e.g., a saline solution when the fluid delivery system (500) is applied in the medical field) is received in the first additional supply station (510) along with the second supply station (10'), and the first fluid is different from the second fluid.

[0124] Let us assume that a fluid delivery system (500) is required to deliver, for example, a first given volume of a second fluid, then a second given volume of a mixture of the first fluid and the second fluid, and finally a third given volume of a second fluid, thereby defining a delivery protocol (injection protocol) to be administered to a given patient.

[0125] As far as the second chamber (31') is concerned, since only the second fluid is contained therein, the priming and filling steps of the second chamber (31') are performed similarly to the respective steps previously disclosed with reference to the embodiments of FIGS. 9 and FIGS. 10.

[0126] With respect to the first chamber (31), the filling step is performed by allowing a certain amount of first fluid to enter the second sub-chamber (36) and a certain amount of second fluid to enter the first sub-chamber (35). This is achieved by opening the first supply station valve (11) and the additional supply station valve (511) while keeping the first actuator (70) in a closed operating state initially. Thus, thanks to the forward and backward translation of the piston (32) (common to both the first and second chambers (31, 31'), underpressure is alternately generated in the two first and second sub-chambers (35, 36), thereby allowing each fluid to enter into each sub-chamber and also enabling the priming of the first inlet fluid circuit (40), the first and second sub-chambers (35, 36), and the first outlet fluid circuit (50), as already disclosed above in this description. As soon as the desired amount of first and second fluids enters the first chamber (31), the processor (P) closes the first supply station valve (11) and the additional supply station valve (511) and opens the first actuator (70). Thus, recirculation of the first fluid from the second sub-chamber (36) to the first sub-chamber (35), as well as recirculation of the second fluid from the first sub-chamber (35) to the second sub-chamber (36) (due to the reversal movement of the piston (32)), is allowed to occur, thereby mixing the first fluid and the second fluid to obtain the desired mixture to be finally delivered.

[0127] As already mentioned above, according to this embodiment, a high concentration contrast agent (e.g., ISOVUE®-370) may be used as the first fluid and saline may be used as the second fluid, so that by appropriately mixing the high concentration contrast agent and saline, the fluid delivery system may be able to provide various volumes of contrast agents at various concentrations, starting from a single type of high concentration contrast agent. This represents a highly advantageous feature of the present disclosure, as the processor (P) can be programmed to calculate the volumes of the first and second fluids to be mixed to obtain a mixture of desired concentrations best suited for a specific patient to be treated (e.g., considering age, weight, gender, race, clinical condition, etc.) and a specific examination to be performed (type of scan, body part to be examined, etc.).

[0128] According to the delivery protocol exemplified above, as soon as the charging and priming steps are completed, the step of delivering the second fluid (e.g., saline solution in the given example) is performed by closing the second actuator (70'), thereby blocking the recirculation of the second fluid within the second chamber (31'). Simultaneously with the step of delivering the second fluid, the step of mixing the first fluid and the second fluid within the first chamber (31) is performed as described above by opening the first actuator (70) of the first recirculating fluid circuit (60). As soon as the required first volume of the second fluid is delivered outside the fluid delivery system (500) (arrow (B')), the second actuator (70') of the second recirculation fluid circuit (60') is activated by the processor (P) to reach an open operating state, allowing the recirculation of the second fluid within the second chamber (31') and stopping the delivery of the second fluid outside the delivery system (500). Meanwhile, the processor (P) closes the first actuator (70) to stop the recirculation of the mixed first fluid and second fluid within the first chamber (31), thereby allowing the resulting mixture (of the desired contrast agent concentration) to be delivered outside the fluid delivery system (500) (arrow (B)). After that, as soon as the desired mixture of the requested second volume is delivered, the processor (P) opens the first actuator (70) to allow the recirculation of the first fluid and the second fluid being mixed within the first chamber (31), and the processor (P) also closes the second actuator (70') so that the final third volume of the second fluid can be delivered according to the delivery protocol described above.

[0129] According to an alternative embodiment of FIG. 13, a first fluid (e.g., a contrast agent when the fluid delivery system (400') is applied in the medical field) is received in the first supply station (10), while a second fluid (e.g., saline solution when the fluid delivery system (400') is applied in the medical field) is received in the first additional supply station (410) along with the second supply station (10'), and the first fluid is different from the second fluid.

[0130] Let us assume that, as shown above with reference to the embodiment of FIG. 8, the fluid delivery system (400') is required to deliver, for example, a first volume of the second fluid, then a second volume of the mixture of the first fluid and the second fluid, and finally a third volume of the second fluid.

[0131] As far as the second chamber (31') is concerned, since only the second fluid is contained within, the priming and filling steps of the second chamber (31') are performed similarly to the respective steps previously disclosed with reference to the embodiments of FIG. 9 and FIG. 10.

[0132] With respect to the first chamber (31), the filling step is performed by allowing a given amount of first fluid to enter the second sub-chamber (36) and a given amount of second fluid to enter the first sub-chamber (35). This is achieved by opening the first supply station valve (11) and the additional supply station valve (411) while initially keeping the first actuator (70) in a closed operating state. Thus, thanks to the forward and backward translation of the piston (32), underpressure is alternately generated in the first and second sub-chambers (35, 36), thereby allowing each fluid to enter into each sub-chamber and also enabling the priming of the first inlet fluid circuit (40), the first and second sub-chambers (35, 36), and the first outlet fluid circuit (50). As soon as the desired amount of first and second fluids enters the first chamber (31), the processor (P) closes the first supply station valve (11) and the additional supply station valve (511) and opens the first actuator (70). Thus, recirculation of the first fluid from the second sub-chamber (36) to the first sub-chamber (35), as well as recirculation of the second fluid from the first sub-chamber (35) to the second sub-chamber (36) (due to the reversal movement of the piston (32)), is allowed to occur, thereby mixing the first fluid and the second fluid to obtain the desired mixture to be finally delivered.

[0133] According to the transfer protocol exemplified above, as soon as the charging and priming steps are completed, the transfer step of the second fluid (e.g., saline solution in the given example) is performed by closing the second actuator (70'), thereby blocking the recirculation of the second fluid within the second chamber (31'). Preferably, simultaneously with the transfer step of the second fluid, the step of mixing the first fluid and the second fluid within the first chamber (31) is performed as described above by opening the first actuator (70) of the first recirculating fluid circuit (60). As soon as the required first volume of the second fluid is delivered outside the fluid delivery system (400') (arrow (B')), the second actuator (70') of the second recirculation fluid circuit (60') is activated by the processor (P) to reach an open operating state, allowing the recirculation of the second fluid within the second chamber (31') and stopping the delivery of the second fluid outside the delivery system (400'). Meanwhile, the processor (P) closes the first actuator (70) to stop the recirculation of the first fluid and the second fluid mixed within the first chamber (31), thereby allowing the resulting mixture (of the desired contrast agent concentration) to be delivered outside the fluid delivery system (400') (arrow (B)). After that, as soon as the desired mixture of the desired second volume is delivered, the processor (P) opens the first actuator (70) to allow the recirculation of the first fluid and the second fluid being mixed within the first chamber (31), and the processor (P) also closes the second actuator (70') so that the final third volume of the second fluid can be delivered according to the delivery protocol described above.

[0134] According to another embodiment illustrated in FIG. 14, the fluid delivery system (400) is very similar to the fluid delivery system (400) of FIG. 7, except for the difference that the second recirculating fluid circuit is not considered. In fact, for example, because there is no need to maintain or reach a given homogeneity of the second fluid (e.g., if the second fluid is saline), the second fluid contained within the second supply station (10') is not required to be recirculated within the second chamber (31'), thanks to the fact that the fluid delivery system (400) includes two separate and independent drive units (M, M'), the delivery of the second fluid (arrow (B')) is performed exactly at the given moment when the second fluid is required to be delivered by the processor (P) through the activation of the drive unit (M') (and thus through the movement of the second piston (32'). In other words, according to this embodiment, the second chamber (31') of the second pump module (30') can be filled and discharged without the need to recirculate the second fluid within the second chamber (31').

[0135] Change example

[0136] 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, while the present disclosure has been described with some degree of specificity with reference to one or more of its embodiments, it should be understood that other embodiments are possible with various omissions, substitutions, and changes in form and detail. In particular, various embodiments of the present disclosure may be practiced without specific details (e.g., numerical values) described in the prior art to provide a more complete 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 specific elements and / or method steps described in connection with any embodiment of the present disclosure may be incorporated into any other embodiment as a matter of overall design choice. In any case, each numerical value should be read as modified by the term "approximately" (where not already so), and the range of each numerical value should be intended to explicitly specify any possible number (including endpoints) along a continuum within the range. Additionally, ordinal numbers or other qualifiers are used as labels to distinguish elements of the same name, but they do not imply priority, pre-existence, or order in themselves. The terms 'include', 'have', 'equip', 'contain' (and any of these forms) are intended in an open and incomplete sense (i.e., not limited to the cited item); the terms 'based on', 'depending on', 'by', 'correlated of' (and any of these forms) are intended in a non-exclusive relationship (i.e., including possible additional variables); the singular form of a term is intended for one or more items (unless otherwise explicitly indicated); and the term 'means for' (or any means plus function phrase) is intended as a structure fitted or configured to perform a relevant function.

[0137] As disclosed above, the actuator and supply station valve of the recirculating fluid circuit are active valves controlled by the processor (P), while the remaining valves of the fluid delivery system are check valves that do not need to be operated by the processor (P). According to another embodiment (not shown in the drawings), to improve the safety and reliability of the fluid delivery system of the present disclosure, all valves of the fluid delivery system are active mechanical valves or active mechanical clamps controlled by the processor (P). In detail, the active mechanical valve / clamp is a mechanical gate that opens and closes the fluid path by acting radially on the outer surface of the fluid path.

[0138] According to an embodiment of the present invention (not shown in the drawings), the volume of the supply station is significantly larger than the volume of the chamber of the fluid delivery system. This embodiment is particularly advantageous because it ensures that a large number of deliveries (e.g., injections or infusions) can be performed without requiring frequent replacement of fluid containers, and also ensures that the overall size of the fluid delivery system can be advantageously minimized, thereby making the fluid delivery system more flexible, less cumbersome, portable (if necessary), and cheaper.

[0139] According to another embodiment, a method for operating a fluid delivery system of the present invention comprises the steps of calculating an amount (volume) of fluid to be delivered for a given application, and then translating a piston axially to define a subchamber of substantially the same volume as the calculated volume of fluid to be delivered. This embodiment is particularly important when it is required that a small amount of fluid (i.e., less than the chamber volume of the fluid delivery system) be delivered, and thus it is desirable to prevent the reversal of piston movement and also prevent any associated possible delivery disturbance / delay by delivering such a small amount while the piston is translated axially along a single direction.

[0140] Alternatively, the above-mentioned calculation step is not performed by the processor of the fluid delivery system. On the other hand, the calculated fluid volume to be delivered is calculated offline and continuously provided to the processor as delivery input data. Thus, immediately before the delivery step begins, a piston is translated axially to define a sub-chamber having a volume corresponding to the calculated volume.

[0141] According to an alternative application example (not illustrated in the drawings), the delivery system of the present disclosure is not necessarily used to deliver at least a first and second fluid, or more than two fluids, or a mixture thereof. In practice, the delivery system can be used to produce customized formulations according to any specific need by dosing the fluids. For example, if the delivery system of the present disclosure is used in the medical field, two or more liquid medicines can be appropriately dosed and then collected in a suitable reservoir (e.g., a pouch) customized to the advantage of a given patient, thereby reducing or preventing the waste of valuable and expensive materials. As mentioned above, the chambers of each pump module (and each sub-chamber therewith), along with the supply station, may have different appropriate volumes so that the delivery / administration / collection of different fluids can be controlled according to the actual needs of each specific case (by appropriately programming the processor (P)). Customizing the injection, customizing a given preparation to be administered sequentially (e.g., filling a pouch for subsequent intravenous administration), or customizing the concentration of a given contrast agent to be injected are all advantageous aspects that make the delivery system of the present disclosure highly versatile and valuable.

[0142] The delivery system of the present disclosure also enables the alternating delivery (or better described as injection) of very small, individual volumes of a first fluid and a second fluid by rapidly switching between two pump modules (e.g., by a processor (P) sequentially activating / deactivating the first and second actuators of the first and second recirculating fluid circuits). In other words, thanks to the delivery system of the present invention, a mixture of contrast agent and saline solution can be administered (i.e., injected) to the patient in rapid, continuous alternation so that it takes place within the patient's trachea, e.g., within the heart. This particular injection phase (known as Diluject® or Rapid Phasing, a specific technical feature of the CT Expres® automatic syringeless injector manufactured by Bracco Injeneering SA) can be performed with improved efficiency and reliability by using the delivery system of the present disclosure.

[0143] The following are preferred embodiments and examples of the present disclosure.

[0144] 1. In a fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500),

[0145] - At least one first supply station (10) for supplying a first fluid and at least one second supply station (10') for supplying a second fluid different from the first fluid;

[0146] - As a pressurizing unit (20) for pressurizing the first fluid and the second fluid,

[0147] A first pump module (30) comprising a first chamber (31) and a first piston (32) accommodated within the first chamber (31), wherein the first piston (32) is configured to have a first plunger (34) that cooperates with the inner wall of the first chamber (31) to define the first and second variable volume subchambers (35, 36) of the first chamber (31); and

[0148] A pressurizing unit (20) comprising: a second pump module (30') including a second chamber (31') and a second piston (32') accommodated within the second chamber (31'), wherein the second pump module (30') is configured to have a second plunger (34') that cooperates with the inner wall of the second chamber (31') to define the first and second variable volume sub-chambers (35', 36') of the second chamber (31');

[0149] - A first inlet fluid circuit (40) fluidly communicating with the at least one first supply station (10) and the first pump module (30) to supply the first fluid to the first and second variable volume subchambers (35, 36) of the first chamber (31);

[0150] - A second inlet fluid circuit (40') fluidly communicating with the at least one second supply station (10') and the second pump module (30') to supply the second fluid to the first and second variable volume subchambers (35', 36') of the second chamber (31');

[0151] - A first recirculating fluid circuit (60, 260) fluidically connecting the first and second variable volume subchambers (35, 36) of the first chamber (31); and

[0152] - A fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) characterized by including a first actuator (70; 270) for managing bidirectional fluid passage between the first and second variable volume subchambers (35, 36) of the first chamber (31), wherein the first actuator (70; 270) is part of the first recirculating fluid circuit (60; 260).

[0153] 2. A fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 500) according to Example 1, further comprising a second recirculating fluid circuit (60'; 260') fluidly connecting the first and second variable volume subchambers (35', 36') of the second chamber (31').

[0154] 3. A fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 500) according to Example 2, characterized in that it further comprises a second actuator (70'; 270') which is part of the second recirculating fluid circuit (60'; 260') as a second actuator (70'; 270') for managing bidirectional fluid passage between the first and second variable volume subchambers (35', 36') of the second chamber (31').

[0155] 4. A fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) according to any one of the prior embodiments, wherein the pressurizing unit (20) further comprises at least one driving unit (M; M') for reciprocating the first and second pistons (32, 32') respectively within the first and second chambers (31, 31').

[0156] 5. A fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) according to any one of the prior embodiments, wherein the fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) further comprises a first outlet fluid circuit (50) that is separated from the first inlet fluid circuit (40) and is fluidly communicating with the first pump module (30) to alternately discharge the first fluid from the first and second variable volume subchambers (35, 36) of the first chamber (31).

[0157] 6. A fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) according to any one of the prior embodiments, wherein the fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) further comprises a second outlet fluid circuit (50') that is separated from the second inlet fluid circuit (40') and is fluidly communicating with the second pump module (30') to alternately discharge the second fluid from the first and second variable volume subchambers (35', 36') of the second chamber (31').

[0158] 7. A fluid transfer system (100; 200; 400; 400'; 400) according to any one of the prior embodiments, wherein the first pump module (30) and the second pump module (30') are arranged in parallel.

[0159] 8. A fluid transfer system (100; 200) according to Example 7, wherein the first piston (32) and the second piston (32') are separated and connected to a common single drive unit (M).

[0160] 9. A fluid transfer system (400; 400'; 400") according to Example 7, wherein the first piston (32) and the second piston (32') are separated and connected to the respective first and second driving units (M, M').

[0161] 10. A fluid transfer system (100'; 100"; 200'; 300; 500) according to any one of prior embodiments 1 to 6, wherein the first pump module (30) and the second pump module (30') are arranged in series.

[0162] 11. A fluid transfer system (100'; 100"; 200'; 300; 500) according to Example 10, wherein the first piston (32) and the second piston (32') form a common piston that translates axially (A; A'; C; D) within the first and second chambers (31, 31').

[0163] 12. A fluid transfer system (100'; 100"; 200'; 300; 500) according to Example 11, wherein the first and second plungers (34, 34') are spaced apart along the common piston (32), and each plunger reciprocates within a corresponding chamber (31; 31').

[0164] 13. A fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) according to any one of the prior embodiments, wherein the first and second inlet fluid circuits (40, 40') include a first inlet fluid path (41; 41') that fluidly communicates with the at least one first supply station (10) and the at least one second supply station (10'), and the first inlet fluid path (41; 41') includes a supply station valve (11; 11').

[0165] 14. In a fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) according to Example 13, downstream of the supply station valve (11; 11'), the first and second inlet fluid circuits (40, 40') each include a second inlet fluid path (42; 42') and a third inlet fluid path (43; 43') that are fluidly communicating with the first variable volume subchamber (35; 35') and the second variable volume subchamber (36; 36'), respectively, and the second inlet fluid path (42; 42') is provided with a first inlet fluid circuit valve (45; 45'), and the third inlet fluid path (43; 43') is provided with a second inlet fluid circuit valve (47; A fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) characterized by being provided with 47').

[0166] 15. A fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) according to embodiments 5 and 6, wherein the first and second outlet fluid circuits (50, 50') each include a first outlet fluid path (51; 51') and a second outlet fluid path (52; 52') that are fluidly communicating with the first variable volume subchamber (35; 35') and the second variable volume subchamber (36; 36'), respectively, and wherein a first outlet fluid circuit valve (55; 55') is provided in the first outlet fluid path (51; 51'), and a second outlet fluid circuit valve (56; 56') is provided in the second outlet fluid path (52; 52'). 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500).

[0167] 16. A fluid transfer system (100; 100'; 100"; 300; 400; 400'; 500) according to embodiments 2 and 3, wherein the first and second recirculating fluid circuits (60, 60') and the first and second actuators (70, 70') coupled to the first and second recirculating fluid circuits (60, 60') are each located outside the first and second chambers (31, 31').

[0168] 17. A fluid transfer system (100; 100'; 100"; 300; 400; 400'; 500) according to Example 16, wherein the first and second recirculating fluid circuits (60, 60') are fluidly connected to the second inlet fluid path (42; 42') downstream of the first inlet fluid circuit valve (45; 45') and to the third inlet fluid path (43; 43') downstream of the second inlet fluid circuit valve (47; 47'), respectively.

[0169] 18. A fluid transfer system (200; 200') according to embodiments 2 and 3, wherein the first and second recirculating fluid circuits (260, 260') and the first and second actuators (270, 270') coupled to the first and second recirculating fluid circuits (260, 260') are each contained within the first and second chambers (31, 31') and are integral with the first and second plungers (34, 34') of the respective first and second pistons (32, 32').

[0170] 19. A fluid transfer system (200; 200') according to Example 18, wherein the first and second recirculating fluid circuits (260, 260') each include a fluid passage obtained within the thickness portion of the first and second plungers (34, 34') respectively to ensure fluid communication between the first and second variable volume subchambers (35; 35' and 36; 36').

[0171] 20. A fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) according to Example 1, characterized by further including a processor (P) that controls and operates the first actuator (70; 270).

[0172] 21. A fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 500) according to Example 3, characterized by further including a processor (P) that controls and operates the second actuator (70'; 270').

[0173] 22. A fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) according to Example 13, characterized by further including a processor (P) that controls and operates the supply station valve (11; 11').

[0174] 23. A fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) according to Example 4, characterized in that it further comprises a processor (P) that controls and operates at least one driving unit (M; M').

[0175] 24. A fluid transfer system (400'; 500) according to any one of the prior embodiments, characterized by further including an additional supply station (410; 510).

[0176] 25. A fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) according to Examples 20 to 22, wherein the first and second actuators (70; 270 and 70'; 270') and the supply station valve (11; 11') are active valves operated by the processor (P).

[0177] 26. A fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) according to Example 20, wherein all valves (70; 70'; 270; 270'; 11; 11'; 45; 45'; 47; 47'; 55; 55'; 56; 56') of the fluid transfer system are active mechanical clamps operated by the control unit (P).

[0178] 27. A fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) according to any one of the prior embodiments, wherein the volumes of the first and second supply stations (10, 10') are significantly larger than the volumes of the first and second chambers (31, 31') of the fluid transfer system.

[0179] 28. A fluid delivery system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) according to any one of the prior embodiments, wherein the fluid delivery system is an injection system, and the first and second fluids are medical fluids selected from liquid pharmaceuticals, drugs, diagnostic active contrast agents, saline solution, or mixtures thereof.

[0180] 29. A method of operating a fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) to transfer at least a first fluid and a second fluid different from the first fluid, wherein

[0181] - A step of delivering the second fluid to the outside of the fluid transfer system;

[0182] - A step of recirculating the first fluid internally within the fluid transfer system; and

[0183] - A method characterized by including the step of delivering the first fluid to the outside of the fluid delivery system.

[0184] 30. A method according to Example 29, wherein the step of delivering the second fluid to the outside of the fluid delivery system is performed simultaneously with the step of recirculating the first fluid internally within the fluid delivery system.

[0185] 31. A method according to Examples 29 and 30, wherein the step of delivering the first fluid to the outside of the fluid delivery system is performed after the step of delivering the second fluid to the outside of the fluid delivery system has been stopped.

[0186] 32. A method of operating a fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 500) to transfer at least a first fluid and a second fluid different from the first fluid, wherein

[0187] - A step of delivering the first fluid to the outside of the fluid transfer system;

[0188] - A step of recirculating the second fluid internally within the fluid transfer system;

[0189] - A step of delivering the second fluid to the outside of the fluid transfer system; and

[0190] - A method characterized by including the step of internally recirculating a first fluid in the fluid transfer system.

[0191] 33. A method according to Example 32, wherein the step of recirculating the second fluid internally within the fluid transfer system is performed substantially simultaneously with the step of transferring the first fluid to the outside of the fluid transfer system.

[0192] 34. A method according to Examples 32 and 33, wherein the step of recirculating the first fluid internally within the fluid transfer system is performed substantially simultaneously with the step of transferring the second fluid to the outside of the fluid transfer system.

[0193] 35. A method according to any one of Examples 32 to 34, wherein the step of delivering a first fluid to the outside of the fluid delivery system is performed alternately with the step of delivering a second fluid to the outside of the fluid delivery system.

[0194] 36. A fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) comprises at least one first supply station (10) for supplying a first fluid and at least one second supply station (10') for supplying a second fluid different from the first fluid, and the fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 500) further comprises a pressurizing unit (20) provided with a first pump module (30) and a second pump module (30'), and each of the first and second pump modules (30; 30') each comprises a chamber (31; 31') and a piston (32) that reciprocates (A; A'; C; D) inside; A method for operating a fluid transfer system (100; 100'; 100"; 200; 200'; 300'; 500) having a plunger (34; 34') that cooperates with the inner wall of the chamber (31; 31') to define the first and second variable volume subchambers (35; 35' and 36; 36'), wherein the fluid transfer system further comprises a first recirculating fluid path (60; 260) for fluid-fluidly connecting the first and second variable volume subchambers (35, 36) of the first chamber (31) and a first actuator (70; 270) coupled to the first recirculating fluid path (60; 260).

[0195] - A step of supplying the first fluid from the first supply station (10) to the first and second variable volume subchambers (35, 36) of the first chamber (31);

[0196] - A step of supplying the second fluid from the second supply station (10') to the first and second variable volume sub-chambers (35', 36') of the second chamber (31');

[0197] - A step of axially translating each piston (32, 32') within the first and second chambers (31, 31') (A; A'; C; D); and

[0198] - A method characterized by including the step of operating the first actuator (70; 270) to recirculate the first fluid within the first chamber (31).

[0199] 37. A method according to Example 36, wherein the method further comprises the step of delivering the first fluid to the outside of the fluid delivery system and the step of delivering the second fluid to the outside of the fluid delivery system, wherein the step of delivering the first fluid and the step of delivering the second fluid are performed alternately.

[0200] 38. A method according to Example 36, wherein the fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 500) further comprises a second recirculating fluid path (60'; 260') for fluidically connecting the first and second variable volume subchambers (35', 36') of the second chamber (31') and a second actuator (70'; 270') coupled to the second recirculating fluid path (60'; 260'), and the method further comprises the step of operating the second actuator (70'; 270') to recirculate the second fluid within the second chamber (31').

[0201] 39. A method according to Examples 37 and 38, wherein the step of delivering the first fluid to the outside of the fluid delivery system is performed simultaneously with the step of recirculating the second fluid.

[0202] 40. A method according to Examples 37 and 38, wherein the step of delivering the second fluid to the outside of the fluid delivery system is performed simultaneously with the step of recirculating the first fluid.

[0203] 41. A method according to any one of Examples 38 to 40, wherein the recirculating steps are performed by causing the first fluid and the second fluid to flow through the first and second recirculating fluid paths (60; 260 and 60'; 260'), respectively, during a plurality of axial translational movements (A; A'; C; D) of each piston (32, 32') within the first and second chambers (31, 31').

[0204] 42. A method according to Example 37, characterized in that the step of recirculating the first fluid is repeated sequentially until the step of delivering the second fluid outside the fluid delivery system is completed.

[0205] 43. A method according to Example 38, characterized in that the step of recirculating the second fluid is repeated sequentially until the step of delivering the first fluid outside the fluid delivery system is completed.

[0206] 44. In the method according to Example 36, the fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) further comprises a valve (11) coupled to the first supply station (10), and the pressurizing unit (20) further comprises at least one driving unit (M; M'), and the step of supplying the first fluid includes the step of filling the first chamber (31) with the first fluid, and the step of filling the first chamber (31) comprises:

[0207] - A step of opening the valve (11) connected to the first supply station (10);

[0208] - A step of closing the first actuator (70; 270) of the first recirculating fluid path (60; 260); and

[0209] - A method further comprising the step of acting on the driving unit (M) to reciprocate the piston (32) within the first chamber (31).

[0210] 45. In the method according to Example 38, the fluid delivery system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 500) further comprises a valve (11') coupled to the second supply station (10'), the pressurizing unit (20) further comprises at least one driving unit (M; M'), the step of supplying the second fluid comprises the step of filling the second chamber (31') with the second fluid, and the step of filling the second chamber (31') comprises:

[0211] - A step of opening the valve (11') connected to the second supply station (10');

[0212] - A step of closing the second actuator (70'; 270') of the second recirculating fluid path (60'; 260'); and

[0213] - A method further comprising the step of acting on the driving unit (M; M') to reciprocate the piston (32') within the second chamber (31').

[0214] 46. ​​A method according to Examples 44 and 45, further comprising the step of priming air to the outside of the fluid transfer system, wherein the priming step is performed simultaneously with the step of filling the first and second chambers (31, 31').

[0215] 47. In a method according to any one of Examples 36 to 46,

[0216] - A step of calculating the volume of the first fluid and the volume of the second fluid to be delivered for a given application; and

[0217] - A method further comprising the step of axially translating each piston (32, 32') to define the volume of the sub-chamber (35, 36, 35', 36') substantially equal to the calculated volume of the first fluid to be delivered and the volume of the second fluid (A, A', C, D).

[0218] 48. In the method according to Example 31,

[0219] - A step of providing the volume of a first fluid and the volume of a second fluid to be delivered to a given application as input delivery data; and

[0220] - A method further comprising the step of axially translating each piston (32; 32') to define the volume of the sub-chamber (35; 36; 35'; 36') substantially equal to the calculated volume of the first fluid to be delivered and the volume of the second fluid.

[0221] 49. A method of operating a fluid transfer system (400'; 400"; 500) to transfer a first fluid and also to transfer a mixture of the first fluid and a second fluid different from the first fluid, wherein

[0222] - A step of delivering the first fluid to the outside of the fluid transfer system;

[0223] - A step of recirculating the first fluid and the second fluid internally within the fluid transfer system to create the above mixture; and

[0224] A method for operating a fluid transfer system (400'; 400"; 500) characterized by including the step of transferring the mixture to the outside of the fluid transfer system.

[0225] 50. A method for operating a fluid transfer system (400'; 500) according to Example 49, further comprising the step of recirculating the first fluid internally within the fluid transfer system.

[0226] 51. A method for operating a fluid transfer system according to Example 49, wherein the step of recirculating the first fluid and the second fluid internally within the fluid transfer system is performed substantially simultaneously with the first step of transferring the first fluid to the outside of the fluid transfer system.

[0227] 52. A method for operating a fluid transfer system according to Example 50, wherein the step of recirculating the first fluid internally within the fluid transfer system is performed substantially simultaneously with the step of transferring the mixture to the outside of the fluid transfer system.

[0228] 53. A method for operating a fluid transfer system according to Example 49, wherein the step of transferring the first fluid to the outside of the fluid transfer system is performed alternately with the step of transferring the second fluid to the outside of the fluid transfer system.

Claims

Claim 1 In a fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500), - at least one first supply station (10) for supplying a first fluid and at least one second supply station (10') for supplying a second fluid different from the first fluid; - a pressurizing unit (20) for pressurizing the first fluid and the second fluid, A first pump module (30) comprising a first chamber (31) and a first piston (32) accommodated within the first chamber (31), wherein the first piston (32) is configured to have a first plunger (34) that cooperates with the inner wall of the first chamber (31) to define the first and second variable volume subchambers (35, 36) of the first chamber (31); and A pressurizing unit (20) comprising: a second pump module (30') comprising a second chamber (31') and a second piston (32') accommodated within the second chamber (31'), wherein the second pump module (30') is configured to have a second plunger (34') that cooperates with the inner wall of the second chamber (31') to define the first and second variable volume sub-chambers (35', 36') of the second chamber (31'); and a first inlet fluid circuit (40) fluidly communicating with the at least one first supply station (10) and the first pump module (30) to supply the first fluid to the first and second variable volume sub-chambers (35, 36) of the first chamber (31); - A second inlet fluid circuit (40') fluidly communicating with the at least one second supply station (10') and the second pump module (30') to supply the second fluid to the first and second variable volume subchambers (35', 36') of the second chamber (31'); - A first recirculating fluid circuit (60, 260) fluidically connecting the first and second variable volume subchambers (35, 36) of the first chamber (31); - A first actuator (70; 270) for managing bidirectional fluid passage between the first and second variable volume subchambers (35, 36) of the first chamber (31) when it is required that the first fluid not be delivered outside the fluid transfer system, wherein the first actuator (70; 270) is part of the first recirculating fluid circuit (60; 260) and is an active valve controlled and operated by a processor (P) of the fluid transfer system; a second recirculating fluid circuit (60'; 260') fluidly connecting the first and second variable volume subchambers (35', 36') of the second chamber (31'); and a second actuator (70') for managing bidirectional fluid passage between the first and second variable volume sub-chambers (35', 36') of the second chamber (31');A fluid delivery system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) comprising a second actuator (70'; 270') which is part of the second recirculating fluid circuit (60'; 260'); wherein the fluid delivery system is an injection system, and the first and second fluids are medical fluids selected from liquid pharmaceuticals, drugs, diagnostic active contrast agents, saline solution, or mixtures thereof. Claim 2 A fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) wherein the pressurizing unit (20) further comprises at least one driving unit (M; M') for reciprocating the first and second pistons (32, 32') respectively within the first and second chambers (31, 31'). Claim 3 A fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) according to claim 1 or 2, further comprising a first outlet fluid circuit (50) separated from the first inlet fluid circuit (40) as a first outlet fluid circuit (50) that fluidly communicates with the first pump module (30) to alternately discharge the first fluid from the first and second variable volume subchambers (35, 36) of the first chamber (31). Claim 4 A fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) according to claim 1 or 2, further comprising a second outlet fluid circuit (50') separated from the second inlet fluid circuit (40') as a second outlet fluid circuit (50') that fluidly communicates with the second pump module (30') to alternately discharge the second fluid from the first and second variable volume sub-chambers (35', 36') of the second chamber (31'). Claim 5 A fluid transfer system (100; 200; 400; 400'; 400) according to claim 1 or 2, characterized in that the first pump module (30) and the second pump module (30') are arranged in parallel. Claim 6 A fluid transfer system (100'; 100"; 200'; 300; 500) according to claim 1 or 2, characterized in that the first pump module (30) and the second pump module (30') are arranged in series. Claim 7 A fluid delivery system (100; 100'; 100"; 300; 400; 400'; 500) according to claim 1, wherein the first and second recirculating fluid circuits (60, 60') and the first and second actuators (70, 70') coupled to the first and second recirculating fluid circuits (60, 60') are each located outside the first and second chambers (31, 31'). Claim 8 A fluid delivery system (200; 200') according to claim 1, wherein the first and second recirculating fluid circuits (260, 260') and the first and second actuators (270, 270') coupled to the first and second recirculating fluid circuits (260, 260') are each contained within the first and second chambers (31, 31') and are integral with the first and second plungers (34, 34') of the first and second pistons (32, 32'). Claim 9 A fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 400"; 500) comprises at least one first supply station (10) for supplying a first fluid and at least one second supply station (10') for supplying a second fluid different from the first fluid, and the fluid transfer system (100; 100'; 100"; 200; 200'; 300; 400; 400'; 500) further comprises a pressurizing unit (20) provided with a first pump module (30) and a second pump module (30'), and each of the first and second pump modules (30; 30') comprises a first and second chamber (31; 31') respectively and a piston (32) that reciprocates (A; A'; C; D) inside; The fluid transfer system (100; 100'; 100"; 200; 200'; 300'; 300'; 400'; 500) further comprises a first recirculating fluid path (60; 260) for fluidically connecting the first and second variable volume subchambers (35, 36) of the first chamber (31) and a first actuator (70; 270) coupled to the first recirculating fluid path (60; 260), and the fluid transfer system (100; A method for operating the fluid transfer system, wherein the system further comprises a processor (P) that performs the following steps: - supplying the first fluid from the first supply station (10) to the first and second variable volume subchambers (35, 36) of the first chamber (31);- A step of supplying the second fluid from the second supply station (10') to the first and second variable volume sub-chambers (35', 36') of the second chamber (31'); - A step of axially translating each piston (32, 32') within the first and second chambers (31, 31') (A; A'; C; D); and - A step of operating the first actuator (70; 270) to recirculate the first fluid within the first chamber (31); characterized by comprising: a method for operating a fluid transfer system. Claim 10 delete Claim 11 delete Claim 12 delete Claim 13 delete Claim 14 delete Claim 15 delete Claim 16 delete Claim 17 delete

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