Systems and methods for delivering fluids using tubing to retain contrast agents prior to normal saline irrigation

Abstract

A system for delivering a precise, small volume medical fluid to a patient is described. The system includes a first tubing kit having a first length of tubing and a second length of tubing, a first connector member disposed at a proximal end of the first length of tubing and configured to connect to a syringe, and a valve assembly disposed at a distal end of the first length of tubing. The system utilizes a section of a tube of a first length to measure and contain a small volume of medical fluid for flushing it into a patient through a valve assembly and a tube of a second length.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 457,940, filed April 7, 2023, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure relates to devices, systems, and methods associated with medical devices for delivering medical fluids to patients, and more particularly to devices, systems, and methods for accurately and / or in small volumes of medical fluids using fluid infusion systems, for maintaining and / or delivering accurate and / or in small volumes of medical fluids. Background Technology

[0004] Infusion systems, such as fluid infusion systems (e.g., medical fluid delivery systems), can be used by healthcare practitioners in medical diagnostic and / or medical treatment procedures. For example, a healthcare practitioner may use a fluid infusion system to infuse one or more medical fluids into a patient. Fluid infusion systems can be used to pressurize and infuse medical fluids (e.g., radiographic materials (e.g., contrast agents, contrast media, etc.)) and / or irrigating agents (e.g., saline) during medical imaging procedures such as angiography (CV), computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), and positron emission tomography (PET)). Fluid infusion systems can also be used to deliver medical fluids or liquid medications to patients during other procedures and / or treatments, including nuclear medicine imaging, molecular imaging, radiopharmaceutical infusion, and local cardiovascular therapies. In some cases, fluid infusion systems are designed to deliver a specific volume of medical fluid into a patient at one or more flow rates.

[0005] In medical treatments or medical procedures, the amount of medical fluid that must be delivered to a patient is a dose measured by volume. In some cases, an accurate measurement of the dose to be delivered to a patient is critical for proper imaging or proper treatment and to avoid adverse reactions or complications to the patient’s health. Improvements in imaging systems and contrast agents also allow or require lower doses of contrast agent to be used in procedures while still obtaining accurate and detailed images. For example, imaging systems are becoming more sensitive to contrast agents, predictive artificial intelligence algorithms allow for less volume of contrast agent to be used, and contrast agents with higher relaxivity are being developed. These factors allow for less volume of contrast agent to be used during a procedure. However, known fluid injection systems typically include larger injectors and more volume of syringes and do not provide sufficient volume control or accurate measurements to indicate the precise dose for patient delivery. For example, an MRI procedure for an average adult male can have previously required over 30 milliliters of liquid contrast agent to perform accurate imaging. Given improvements in imaging systems and contrast agents, an MRI procedure for an average adult male can require less than 30 milliliters or even less than 20 milliliters of contrast agent. In some cases, a dose for an average adult male can be as low as 8 milliliters to 15 milliliters. In some cases, a dose for a pediatric patient can be as small as 1 milliliter to 2 milliliters of contrast agent. In some cases, certain procedures or treatments can require a precise dose of medical fluid as little as 0.1 milliliters to 0.5 milliliters.

[0006] Furthermore, using excess volume of contrast agent is not a small expense for the care provider and ultimately for their patient. Therefore, volume is an important factor in the cost associated with manufacturing, distributing, and using contrast agents, and limiting the volume use of contrast agents is critical to limit the cost to health care professionals and patients.

[0007] In view of the foregoing, there is a need for devices, systems, and methods of measuring, maintaining, and / or delivering precise and / or small volumes of medical fluid using fluid injection systems. SUMMARY

[0008] Accordingly, aspects of the present disclosure are directed to non-limiting embodiments of devices, systems, and methods of measuring, maintaining, and / or delivering precise and / or small volumes of medical fluid using fluid injection systems.

[0009] According to an aspect of the present disclosure, a system for delivering fluid to a patient, the system comprising: a first tubing set having a first length of tubing and a second length of tubing, the first and second lengths of tubing each having a proximal end and a distal end. A first connector member is disposed at the proximal end of the first length of tubing, the first connector member configured to connect to a flush syringe, and a valve assembly is disposed at the distal end of the first length of tubing. The valve assembly includes: a proximal port, a distal port, and a third port. A second connector connects the distal end of the first length of tubing to the proximal port. A third connector member is connected to the distal port. A fourth connector member connects a first wipeable valve and a second length of tubing to the third port. The system further includes a container containing a medical fluid, the container removably connected to the first wipeable valve. The valve assembly selectively provides fluid connection between the proximal port, the distal port, and the third port.

[0010] According to another aspect of the present disclosure, a system for delivering fluid to a patient, the system comprising: a first length of tubing having a proximal end and a distal end, a first syringe connected to the proximal end of the first length of tubing, and a valve assembly disposed at the distal end of the first length of tubing. The valve assembly includes: a first port, a second port, and a third port; a connector member connected to each of the first, second, and third ports; and a first wipeable valve connected to the third port. The second port is connected to a proximal end of a second tubing set and a catheter configured to be fluidly connectable to a patient. The distal end of the first length of tubing is connected to the first port, and a container containing a medical fluid is removably connected to the valve assembly.

[0011] According to another aspect of the present disclosure, a fluid injection system, comprising: a housing, at least one syringe, at least one drive member, and at least one controller programmed or configured to control actuation of the at least one drive member. The fluid injection system further includes a medication line, a first length of tubing having a proximal end and a distal end, and a first connector member disposed at the proximal end of the first length of tubing, the first connector member configured to connect to the at least one syringe of the fluid injection system. In addition, the system includes a valve assembly disposed at the distal end of the first length of tubing. The valve assembly includes: a proximal port, a distal port, and a third port, a second connector member connecting the distal end of the first length of tubing to the proximal port, a third connector member connecting the distal port to a proximal end of the medication line, and a fourth connector member connecting a first wipeable valve to the third port. The first wipeable valve removably connects a container containing a medical fluid to the third port. The valve assembly selectively provides fluid connection between the proximal port, the distal port, and the third port. The medical fluid is a liquid contrast agent, and the at least one syringe is filled with a flushing fluid.

[0012] According to another aspect of the disclosure, a method of using a fluid injection system, the method comprising: providing a fluid injection system. The method further comprises priming at least one syringe of the system by pushing a flushing fluid into the at least one syringe, connecting a medication line to a third connector member and a proximal port of a valve assembly, and connecting a proximal end of a first length of tubing to the at least one syringe. In addition, the method comprises priming the fluid injection system by actuating at least one drive member and pushing the flushing fluid contained in the at least one syringe through the first length of tubing and through the medication line. The method further comprises connecting a container containing a medical fluid to a first swabbable valve, actuating the at least one drive member to draw a volume of the medical fluid into the first length of tubing, and actuating the at least one drive member to push the volume of the medical fluid from the first length of tubing through the medication line and to a patient.

[0013] Non-limiting examples of embodiments of the present disclosure will now be described in the following numbered clauses.

[0014] Clause 1. A system for delivering a fluid to a patient, the system comprising: a first tubing set having a first length of tubing and a second length of tubing, the first length of tubing and the second length of tubing each having a proximal end and a distal end; a first connector member disposed at the proximal end of the first length of tubing, the first connector member configured to connect to a flushing syringe; and a valve assembly disposed at the distal end of the first length of tubing, the valve assembly comprising: a proximal port, a distal port, and a third port; a second connector member connecting the distal end of the first length of tubing to the proximal port; a third connector member connected to the distal port; and a fourth connector member connecting a first swabbable valve and the second length of tubing to the third port, wherein a container containing a medical fluid is removably connected to the first swabbable valve; and wherein the valve assembly selectively provides a fluid connection between the proximal port, the distal port, and the third port.

[0015] Clause 2. The system of clause 1, wherein the third connector member connected to the distal port is connected to a proximal end of a second tubing set, wherein the second tubing set further comprises a one-way check valve configured to allow fluid flow toward a distal end of the second tubing set.

[0016] Clause 3. The system of clause 1 or 2, wherein the second tubing set is a medication line connected to a catheter configured to be fluidly connectable to a patient.

[0017] Clause 4. The system of any one of clauses 1-3, wherein the medication line is a single-use set.

[0018] Clause 5. The system of any one of clauses 1-4, wherein the first tubing set and the valve assembly are a multi-use set such that it remains sterile and is suitable for use with more than one patient.

[0019] Clause 6. The system of any one of clauses 1-5, wherein the first connector member is connected to a flush syringe, and the flush syringe is a manual syringe, an automatic injector, or a syringe connected to a fluid infusion system.

[0020] Clause 7. The system of any one of clauses 1-6, wherein the flush syringe contains a flushing fluid; and wherein the valve assembly provides a fluid connection between the proximal port of the first tubing set and the distal port of the second tubing set, and actuation of a plunger or piston of the flush syringe pushes the flushing fluid through the second tubing set to flush the administration line.

[0021] Clause 8. The system of any one of clauses 1-7, wherein at least one of the first connector member, the second connector member, the third connector member, and the fourth connector member comprises at least one of a one-way check valve and a luer connector.

[0022] Clause 9. The system of any one of clauses 1-8, wherein the first length of tubing is sized to hold a volume of medical fluid of up to about 30 milliliters.

[0023] Clause 10. The system of any one of clauses 1-9, wherein the first length of tubing is sized to hold a volume of medical fluid ranging from 0.1 milliliters to about 15 milliliters.

[0024] Clause 11. The system of any one of clauses 1-10, wherein the first length of tubing is sized to hold a volume of medical fluid ranging from 0.1 milliliters to about 5 milliliters.

[0025] Clause 12. The system of any one of clauses 1-11, wherein the first length of tubing is made of a translucent polymeric material such that the medical fluid in the first length of tubing is visible to a user and / or a sensor of the fluid infusion system.

[0026] Clause 13. The system of any one of clauses 1-12, wherein the first length of tubing further comprises a marker configured to provide a volumetric measurement of an amount of medical fluid in the first length of tubing.

[0027] Clause 14. The system according to any one of clauses 1 to 13, further comprising a volume control element disposed between the container containing the medical fluid and the first length of tubing; and wherein the valve assembly provides fluid connection between the third port and the proximal port, and the volume control element selectively controls fluid flow between the container and the first length of tubing such that the measured volume of the medical fluid flows from the container into the first length of tubing.

[0028] Clause 15. The system according to any one of clauses 1 to 14, wherein the container containing the medical fluid is a second syringe; and wherein the valve assembly provides fluid connection between the third port and the proximal port, and the second syringe selectively controls fluid flow between the second syringe and the first length of tubing such that the measured volume of the medical fluid flows from the second syringe into the first length of tubing.

[0029] Clause 16. The system according to any one of clauses 1 to 15, wherein the spike is connected to a swabbable valve of the third port, wherein the container containing the medical fluid is a pouch, a bag, a bottle, or another vessel configured to receive the spike; and wherein the container is fluidly connected to the valve assembly when the container receives the spike.

[0030] Clause 17. The system according to any one of clauses 1 to 16, wherein the first connector member is connected to a flush syringe connected to a fluid infusion system, and the fluid infusion system is programmed or controlled to actuate a piston of the flush syringe to draw a predetermined volume of the medical fluid from the container into the first length of tubing.

[0031] Clause 18. The system according to any one of clauses 1 to 17, wherein the second syringe comprises a pulse syringe configured to selectively control fluid flow from the second syringe to the first length of tubing by delivering a predetermined volume of the medical fluid from the pulse syringe into the first length of tubing a predetermined number of times.

[0032] Clause 19. The system according to any one of clauses 1 to 18, wherein the pulse syringe is connected to a fluid infusion system, and the fluid infusion system is programmed or controlled to actuate a piston of the pulse syringe to deliver a predetermined volume of the medical fluid from the pulse syringe into the first length of tubing a predetermined number of times.

[0033] Clause 20. The system according to any one of clauses 1 to 19, wherein the predetermined volume of the medical fluid ranges from 0.1 milliliter to about 1 milliliter.

[0034] Clause 21. The system of any of clauses 1-20 for delivering a fluid to a patient, the system comprising: a first length of tubing having a proximal end and a distal end; a first syringe connected to the proximal end of the first length of tubing; a valve assembly disposed at the distal end of the first length of tubing, the valve assembly comprising: a first port, a second port, and a third port; a connector member connected to each of the first port, the second port, and the third port; and a first wipeable valve connected to the third port; wherein the second port is connected to a proximal end of a second tubing set and a catheter configured to be fluidly connectable to a patient, wherein the distal end of the first length of tubing is connected to the first port, wherein a container containing a medical fluid is removably connected to the valve assembly.

[0035] Clause 22. The system of any of clauses 1-21, wherein the system further comprises: a second syringe; and an additional connector member between the third port and the second syringe; wherein the second syringe is removably connected to the additional connector member and the third port, and wherein the connector member and the additional connector member are configured to selectively control fluid flow between the container, the second syringe, and the first length of tubing such that a measured volume of the medical fluid is allowed to flow from the container to the first length of tubing, or from the second syringe to the first length of tubing.

[0036] Clause 23. The system of any of clauses 1-22, wherein the container is disconnected from the wipeable valve and the wipeable valve receives a valve cap; or the second syringe is disconnected from the additional connector member and the additional connector member receives a connector member cap.

[0037] Clause 24. The system of any of clauses 1-23, wherein the system further comprises a third length of tubing having a proximal end and a distal end, and the container comprises a pre- fill component disposed between the first length of tubing and the valve assembly, wherein the proximal end of the third length of tubing is connected to the first syringe and the distal end of the third length of tubing is connected to the second tubing set, wherein the third length of tubing is a bypass line configured to deliver a flushing fluid to the second tubing set and the patient, and wherein the flushing fluid is delivered through the first length of tubing and the pre-fill component is actuated to deliver the medical fluid through the first length of tubing to the second tubing set and the patient.

[0038] Clause 25. The system of any of clauses 1-24, wherein the first length of tubing further comprises a syringe having a dual-sided plunger.

[0039] Clause 26. The system of any of clauses 1-25, wherein the first length of tubing further comprises a rolling diaphragm.

[0040] Clause 27. The system of any of clauses 1-26, implemented in a fluid injection system comprising: a housing, at least one syringe, at least one drive member, and at least one controller programmed or configured to actuate the at least one drive member; a medication line; a first length of tubing having a proximal end and a distal end; a first connector member disposed at the proximal end of the first length of tubing, the first connector member configured to connect to the at least one syringe of the fluid injection system; and a valve assembly disposed at the distal end of the first length of tubing, the valve assembly comprising: a proximal port, a distal port, and a third port; a second connector member connecting the distal end of the first length of tubing to the proximal port; a third connector member connecting the distal port to a proximal end of the medication line; and a fourth connector member connecting a first wipeable valve to the third port; the first wipeable valve removably connecting a container containing a medical fluid to the third port, wherein the valve assembly selectively provides fluid connection between the proximal port, the distal port, and the third port; and wherein the medical fluid is a liquid contrast agent and the at least one syringe is filled with a flushing fluid.

[0041] Clause 28. The fluid injection system of any of clauses 1-27, wherein the valve assembly provides fluid connection between the proximal port and the distal port, and actuation of the at least one drive member pushes the flushing fluid from the at least one syringe through the medication line to flush the medication line.

[0042] Clause 29. The fluid injection system of any of clauses 1-28, wherein the valve assembly further provides fluid connection between the third port and the proximal port such that a volume of the liquid contrast agent is drawn into the first length of tubing by actuation of the at least one drive member; or wherein the container is a second syringe and a volume of the liquid contrast agent is pushed into the first length of tubing by actuation of a plunger of the second syringe.

[0043] Clause 30. The fluid injection system of any of clauses 1-29, wherein the valve assembly further provides fluid connection between the proximal port and the distal port such that a volume of the liquid contrast agent is pushed from the first length of tubing through the medication line and delivered to a patient by actuation of the at least one drive member.

[0044] Clause 31. The fluid injection system of any of clauses 1-30, further comprising a measurement sensor configured to measure the volume of the liquid contrast agent drawn into the first length of tubing; and wherein the measurement sensor is configured to communicate with the controller when a predetermined volume of the liquid contrast agent is drawn into or pushed into the first length of tubing.

[0045] Clause 32. The fluid injection system of any of clauses 1-31, wherein the fluid injection system further comprises an air sensor disposed on the second length of tubing and / or the administration line; and wherein the air sensor is configured to detect air in the second length of tubing and / or the administration line and communicate detection of air to a controller of the fluid injection system.

[0046] Clause 33. A method of using the fluid injection system of any of clauses 1-32, the method comprising: providing a fluid injection system comprising: a housing, at least one syringe, at least one drive member, and at least one controller programmed or configured to actuate the at least one drive member; an administration line; a first length of tubing having a proximal end and a distal end; a first connector member disposed at the proximal end of the first length of tubing, the first connector member configured to connect to the at least one syringe of the fluid injection system; and a valve assembly disposed at the distal end of the first length of tubing, the valve assembly comprising: a proximal port, a distal port, and a third port; a second connector member connecting the distal end of the first length of tubing to the proximal port; a third connector member connected to the distal port and configured to connect to a proximal end of the administration line; and a fourth connector member connecting the first wipeable valve to the third port; priming the at least one syringe by pushing a priming fluid into the at least one syringe; connecting the administration line to the third connector member and the proximal port of the valve assembly; connecting the proximal end of the first length of tubing to the at least one syringe of the fluid injection system; priming the fluid injection system by actuating the at least one drive member and pushing the priming fluid contained in the at least one syringe through the first length of tubing and through the administration line; connecting a container containing a medical fluid to the first wipeable valve; actuating the at least one drive member to draw a volume of the medical fluid into the first length of tubing; and actuating the at least one drive member to push a dose of the medical fluid from the first length of tubing through the administration line and to a patient.

[0047] More details and advantages of the various examples described in detail herein will become clear on reading the following detailed description of various examples, to be read with the help of the attached drawings. BRIEF DESCRIPTION OF DRAWINGS

[0048] Other advantages and details will be further explained with reference to the drawings in which:

[0049] Figure 1 Non-limiting embodiments of environments are illustrated, including fluid injection systems and medical imaging systems according to an aspect of the present disclosure;

[0050] Figure 2A non-limiting embodiment of a fluid injection system is shown in accordance with one aspect of the present disclosure;

[0051] Figure 3 An enlarged view of an injector head unit of the fluid injection system shown; Figure 2

[0052] Figure 4A An implementation of a non-limiting embodiment of a system for use with a fluid injection system in accordance with one aspect of the present disclosure is shown;

[0053] Figures 4B-4D An implementation of various components of a non-limiting embodiment of a system in accordance with one aspect of the present disclosure, including a syringe, a single-use tubing set, and a multi-use set; Figure 4A

[0054] Figure 4E An implementation of a non-limiting embodiment of a system in accordance with one aspect of the present disclosure during operation of priming a syringe, a single-use tubing set, and a multi-use set with a flushing fluid is shown; Figures 4A-4D

[0055] An implementation of a non-limiting embodiment of a system in accordance with one aspect of the present disclosure during a fill operation is shown; Figure 4F Figures 4A-4E An implementation of a non-limiting embodiment of a system in accordance with one aspect of the present disclosure during an injection procedure is shown, in which a volume of contrast media is drawn into a portion of a multi-use set;

[0056] Figure 4G Figures 4A-4F An implementation of a non-limiting embodiment of a system in accordance with one aspect of the present disclosure during an injection procedure in which a required dose of contrast media is flushed from a multi-use set to a destination is shown;

[0057] Figures 5-12 A schematic view of a non-limiting embodiment of a system for use with a fluid injection system and various components thereof in accordance with aspects of the present disclosure;

[0058] Figure 13 A sequence diagram for a non-limiting embodiment of a method of using an apparatus, system, and / or fluid injection system in accordance with aspects of the present disclosure.

[0059] In the various views, corresponding reference characters indicate corresponding parts. The examples set forth herein demonstrate exemplary embodiments of the present disclosure and should not be construed as limiting the scope of the present disclosure in any manner. DETAILED DESCRIPTION

[0060] ​​​​It should be understood that the disclosure is amenable to various alternative changes and step orders, unless explicitly stated otherwise. It should also be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary and non-limiting embodiments or aspects of the disclosure. Accordingly, unless explicitly stated otherwise, the specific dimensions and other physical characteristics related to the embodiments or aspects disclosed herein are not to be considered as limiting.

[0061] For purposes of the description hereinafter, the terms "end," "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and derivatives thereof shall relate to the embodiments or aspects of the disclosure as they are oriented in the drawings. However, it is to be understood that the embodiments or aspects can assume various alternative orientations and step sequences, except where expressly specified otherwise. Spatial or directional terms, such as "left," "right," "inner," "outer," "above," "below," and the like, are not to be construed as limiting, as the disclosure can assume various alternative orientations.

[0062] All numbers used in the specification and claims should be understood to be approximations unless otherwise indicated in the specific context. The terms "approximately," "about," and "substantially" are used herein to express an intended precision of a value.

[0063] As used herein, the term "at least one of' is synonymous with "one or more of'. For example, the phrase "at least one of A, B, and C" means any one of A, B, and C, or any combination of any two or more of A, B, and C. For example, "at least one of A, B, and C" includes one or more of A alone; or one or more of B alone; or one or more of C alone; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of all of A, B, and C. Similarly, as used herein, the term "at least two of' is synonymous with "two or more of'. For example, the phrase "at least two of D, E, and F" means any combination of any two or more of D, E, and F. For example, "at least two of D, E, and F" includes one or more of D and one or more of E; one or more of D and one or more of F; one or more of E and one or more of F; or one or more of all of D, E, and F.

[0064] No aspect, component, element, structure, act, step, function, instruction, and / or the like recited herein is to be interpreted as being critical or essential to the practice of any aspect, unless explicitly so defined by the claim. Furthermore, as used herein, the articles "a" and "one" are intended to include one or more items, and can be used interchangeably with the

[0065] The term "distal" when used in reference to a component of a fluid injection system, such as a fluid reservoir, a syringe, or a fluid line, refers to the portion of the component closest to a patient. The term "proximal" when used in reference to a component of a fluid injection system, such as a fluid reservoir, a syringe, or a fluid line, refers to the portion of the component closest to an injector of the fluid injection system (i.e., the portion of the component farthest from the patient). The term "proximal" when used in reference to a syringe of a multi-patient disposable set refers to the portion of the syringe closest to a piston for delivering fluid from the syringe. The term "upstream" when used in reference to a component of a fluid injection system, such as a fluid reservoir, a syringe, or a fluid line, refers to a direction away from a patient and toward an injector of the fluid injection system. The term "downstream" when used in reference to a component of a fluid injection system, such as a fluid reservoir, a syringe, or a fluid line, refers to a direction toward a patient and away from an injector of the fluid injection system.

[0066] Embodiments of the present disclosure generally relate to systems for use with a fluid injection system, which can include a first length of tubing and a second length of tubing, a first connector member at a proximal end of the first length of tubing configured to connect to a syringe, and a valve assembly at a distal end of the first length of tubing. The valve assembly can include a proximal port, a distal port, a third port, a second connector member connecting the first length of tubing to the proximal port, a third connector member connected to the distal port, and a fourth connector member connecting a first swabbable valve to the third port. A container containing a medical fluid can be removably connected to the first swabbable valve. The valve assembly can selectively provide fluid connections between the proximal port, the distal port, and the third port. According to various embodiments, the third port of the valve assembly can be a T-shaped port or a Y-shaped port extending perpendicular or at an angle, respectively, to an axis defined between the proximal port and the distal port.

[0067] In this manner, embodiments of the present disclosure allow for precise and / or small volume measurements, maintain precision and / or small volume, and / or deliver precise and / or small volumes of medical fluid, such as small volumes of contrast media, for fluid injection systems and for injection into a patient.

[0068] Referring to the drawings, wherein like reference numbers refer to like elements throughout the several views, the present disclosure generally relates to apparatuses, systems, related components, and methods for holding and / or measuring and ultimately delivering medical fluid to a patient. The present disclosure is generally described in connection with the pressurized injection of liquid radiographic contrast material and / or diluent / flushing agent in procedures such as angiography (CV), computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), X-ray, and positron emission tomography (PET). However, it should be understood that the apparatuses, systems, and methods described herein can also be used in other applications where an accurate dose of fluid, such as contrast media, diluent, therapeutic agent, medicament, drug, etc., is indicated for intravenous injection. Such procedures and / or therapies include, but are not limited to, nuclear medicine imaging, molecular imaging, radiopharmaceutical injection, and cardiovascular regional therapy treatment.

[0069] Further, while the present disclosure can be applied to computed tomography (CT) and / or angiographic-type injection systems, such as the MEDRAD ® Stellant FLEX CT injection system or the MEDRAD ® Mark 7 Arterion injection system, respectively, the present description is applicable to injection systems involved in magnetic resonance (MR) imaging procedures. In particular, the present disclosure is described herein by way of example in connection with the MEDRAD ® MRXperion MR injection system provided by Bayer HealthCare LLC. While the MEDRAD ® MRXperion MR injection system is a dual-head (also referred to as a dual-barrel) type system, it is readily apparent that the present disclosure can also be used in connection with single-head (also referred to as single-barrel) type injection systems. In further embodiments, the injection systems described herein can be used in connection with hand-held barrel injection schemes.

[0070] Reference is first made to Figure 1, showing a non-limiting embodiment of an MR medical imaging suite 800 in which devices, systems, and methods according to the present disclosure can be used. The medical imaging suite 800 can be located in a hospital and / or imaging center for performing imaging procedures on patients for diagnostic purposes. The medical imaging suite 800 can include a scan room 814 in which a fluid injection system 804 and a medical imaging system 806 are located, and a control room 816 from which an operator (e.g., a radiologist) can conduct injection and imaging procedures and monitor a patient through one or more workstation devices 802 associated with the fluid injection system 804 and / or the medical imaging system 806. The fluid injection system 804 can include a multi-fluid delivery system, such as the MEDRAD® ® MRXperion MR injection system introduced above. As shown in Figure 1 , an operator can use the workstation devices 802 to set up and / or execute a fluid injection procedure. In some non-limiting embodiments, the workstation devices 802 can provide a user interface (e.g., an application-based user interface, a web-based user interface, etc.) on a display unit 808 for controlling the fluid injection system 804 and the medical imaging system 806. Parameters of an injection protocol for a fluid injection procedure can be input by a user, called from a common database, or automatically generated by a controller or injection protocol management system associated with the fluid injection system 804, and in some non-limiting embodiments, displayed on the workstation devices 802 and / or communicated to the fluid injection system 804 for execution.

[0071] Reference is now made to Figure 2 , showing a diagram of a non-limiting embodiment of the fluid injection system 804 shown in Figure 1 , of a type that can be used with devices, systems, and methods according to aspects or examples of the present disclosure. In particular, Figure 2 is a MEDRAD ® MRXperion MR injection system. While reference is made to the MEDRAD ®The use of the MRXperion MR injection system describes various embodiments of the present disclosure, but it should be understood that various systems and methods can be applied to other types and brands of fluid injection systems, and that these systems and methods are not limited to a particular fluid injection system. In some non-limiting embodiments, the scan room unit 805 includes a base 811 mounted to a base 813, lockable casters 817 are fixed to the base 813 for moving the scan room unit 805 within the scan room 814 as needed during an imaging procedure. The base 811 can also include an integrated IV pole 818 that includes one or more hooks 819 for hanging IV-related accessories. In some non-limiting embodiments, the base 813 houses various electronic and communication components and a power supply for the scan room unit 805. In other connections, as Figure 1 shown, the scan room unit 805 has a power cable 821 and a fiber optic link 822 in communication with the workstation device 802 to enable control of the operation of the fluid injection system 804 from outside the scan room 814.

[0072] Reference is now made to Figure 3 and with continued reference to Figure 2 which shows Figure 2 an enlarged view of the injector head unit 850 of the fluid injection system 804 shown. In particular, Figure 2 and 3 show non-limiting embodiments of the injector head 850 of the scan room unit 805 of the fluid injection system 804. As shown in these illustrations, the injector head 850 can include a housing 851 and at least one fluid reservoir 860a / 860b, such as at least one syringe. The injection system 804 can include drive members that control the flow of fluid into or out of the fluid reservoirs / syringes, such as a piston associated with each syringe 860a / 860b that drives an associated plunger within the barrel of the syringe. A controller or injection protocol management system can control the actuation of the drive members. Each syringe 860a / 860b is adapted to releasably interface with the housing 851 at a port 855 and is configured to be filled with a medical fluid F, such as an imaging contrast medium in the syringe 860a, and a flushing fluid, such as a saline solution, in the syringe 860b.

[0073] In some non-limiting embodiments, the fluid injection system 804 can be used during a routine imaging procedure to inject contrast medium and / or saline into the vasculature of a patient by selectively driving the plungers or their respective drive members associated with the contrast agent syringe 860a and / or the saline syringe 860b or both. As Figure 3As shown, for each syringe 860a / 860b, during the perfusion, purging, and / or fluid delivery steps, the drive component can move the plunger toward the distal end 861 of the syringe to expel fluid from the syringe into and through the fluid pathway kit 1000. In some non-limiting embodiments, the fluid pathway kit 1000 may include at least one tube or tube assembly configured to be in fluid communication with each syringe 860a / 860b to allow the syringe(s) to be in fluid communication with a flexible drug delivery line and its associated catheter for delivering (multiple) fluids from each or both syringes 860a / 860b to the patient's desired vascular access site.

[0074] like Figure 3 As shown, the injector head 850 may include various control buttons, knobs and indicators that can monitor and influence the operation of the fluid injection system 804.

[0075] For reference Figures 4A-4G This illustrates a non-limiting embodiment of a system 200 for use with a fluid injection system, based on aspects or examples of this disclosure. Figures 4A-4G As shown, for illustrative purposes, system 200 is applied to Figures 1-3 The fluid injection system 804 shown, or alternatively, can be applied to a handheld syringe-based injection device, as illustrated. Figure 4A As shown, in one non-limiting embodiment, the system 200 is used to deliver precise, small-volume medical fluids, such as contrast agents, to a patient. In some non-limiting embodiments, the system 200 may include a combination of a single-use (per patient) tubing kit 220 and a multi-use (daily) kit 230. In other embodiments, the entire system 200 may be configured as a single-use system to be discarded or recycled after the patient infusion protocol is completed. The system 200 may also include a syringe 300. Although this disclosure claims the use of a syringe, it is clearly not necessary to provide it as part of a kit containing components of this disclosure, as such syringes are commercially available from various vendors. Figures 4A-4G As shown, the syringe can be a handheld syringe, or in other embodiments, the syringe can be attached to a fluid injection system as described herein. For example, the syringe can be attached to a single-ended or dual-ended fluid injection system, such as to a syringe filled with physiological saline that is attached to the injector head 850.

[0076] For reference Figures 4B-4D The illustration shows implementations of various components of a non-limiting embodiment of the system 200 of this disclosure, including a syringe 300, a single-use second tubing kit 220, and a multiple-use first tubing kit 230. Figure 4B The operator holding the syringe 300 is shown. Figure 4CAn operator holding a single-use tubing set 220 is shown, and Figure 4D An operator holding a multi-use tubing set 230 is shown. In certain non-limiting embodiments, the syringe 300 can be a hand-held syringe, or alternatively, can be configured to connect to an injector head 850 of an injection system 804, and likewise, can be implemented as a saline or flush fluid syringe 860b that releasably attaches to the injector head 850 at a designated port 855. In other embodiments, the flush fluid can be actuated and caused to flow by a peristaltic pump assembly. Preferably implemented as a low-pressure tubing set, the single-use tubing set 220 has a one-way check valve 222, for example at its distal end, that is intended to connect to a catheter that is to be inserted into a suitable blood vessel of a patient. The check valve 222 can prevent backflow through the single-use component as well as contamination of the upstream multi-use component by bodily fluids and / or microbiological contaminants. At its proximal end, the single-use tubing set 220 is intended to connect to the distal end of the multi-use tubing set 230. The multi-use set 230 is adapted at its proximal end to connect to the syringe 300, for example, as implemented by the saline syringe 860b of the injection system 804 as shown in Figure 2 and 3

[0077] As shown in Figure 4D , the multi-use set 230 includes a first tubing set 230 having a tubing 232 of a first length, a pre-filled syringe 234, a three-way stopcock valve assembly 240, and a swabbable valve 250, for example, commercially available from Halkey-Roberts of St. Petersburg, Florida. Although shown in Figure 4D as a pre-filled syringe containing MR contrast agent, the pre-filled syringe 234 can alternatively be implemented in different forms, for example, a bag, pouch, or other suitable holder of MR contrast media, for example, a vial to which a spike on the valve assembly 240 can be connected. The inner diameter of the tubing 232 of the first length can be greater than, equal to, or less than the inner diameter of the single-use tubing set 220. At its proximal end, the tubing segment 232 is designed to connect by a luer connector or other suitable connector 233 to the nozzle 310 of the syringe 300 / 860b. The three-way valve assembly 240 features a proximal port 242, a distal port 244, and a third port 246. As shown in Figure 4C ​As shown, the proximal port 242 is connected to the distal end of the first length of tubing 232 by a second connector member, such as a luer connector or other suitable connector, and the distal port 244 is designed to be connected to the proximal end of the single-use tubing set 220 by a second connector member, such as a luer connector or other suitable connector 224. The third port 246 is designed to be connected to a fourth connector member by a wipeable valve 250 or other suitable dripless valve assembly, the other end of which is intended to be connected to a luer tip of a medical fluid container, such as a prefilled syringe 234. In this non-limiting embodiment, the prefilled syringe 234 is filled with MR contrast agent. The syringe 234 can include markings on its outer surface that indicate the volume of contrast medium contained therein and allow the user to determine the volume of contrast medium to be injected into the first length of tubing, as described herein. In certain embodiments, the syringe 234 can be a hand-held syringe and include one or more stoppers or threads, such as on a plunger of the syringe 234, that allow for precise dosing by moving the desired number of stoppers or dialing out the correct number of threads to accurately transfer a small volume of contrast medium from the syringe 234 into the first length of tubing 232. Alternatively, the syringe 234 can be a precision dosing syringe, such as a microdosing syringe, that has the precise desired volume of contrast agent for use in a single injection protocol, such that the precise volume of contrast agent is injected from the syringe 234 into the first length of tubing 232.

[0078] The present system 200 is suitable for connection to the fluid injection system 804 described herein and operation in accordance with the exemplary methods thereof. For example, with its proximal end connected to the appropriate port 855 of the injector head 850, the syringe 300 / 860b can be connected by its nozzle 310 to the first length of tubing 232 of the multi-use set 230 via a luer connection or other suitable connector 233. At the other end of the multi-use set 230, the distal port 244 of the valve assembly 240 can be connected to the proximal end of the single-use tubing set 220 via a third connector member by a luer connector or other suitable connector 224. Assembled in this manner, the present system 200 will be ready for use with the fluid injection system 804 having an injection procedure for a contrast-enhanced imaging procedure.

[0079] Prior to connection to the multi-use tubing set 230, the syringe 300 / 860b according to the present method embodiments can be primed with saline from a bag, bottle, or other suitable container. With its nozzle 310 connected to the container, the syringe 300 / 860b can be filled with saline or other flushing fluid and any air manually or automatically primed from the syringe using the fluid injection system 804. Once primed, the saline syringe 300 / 860b is ready to be connected to the first connector member at the proximal end of the first length of tubing 232 of the multi-use set 230 as described above. In the case of the multi-use set 230 connected to the single-use tubing set 220 (as described herein), the saline syringe 300 / 860b is ready for priming of the first length of tubing 232 of the multi-use set 230 and the single-use second tubing set 220 as Figure 4E shown. During priming of the first length of tubing 232 and the single-use second tubing set 220, no saline will flow into the pre-filled syringe 234 (or other suitable container 234) as the valve assembly 240 is configured to prevent fluid communication with the third port. In various embodiments, the pre-filled syringe 234 does not need to be connected to the wipeable valve 250 when the tubing segment 232 and the single-use tubing set 220 are primed with saline. In various embodiments, a one-way valve within the wipeable valve 250 can prevent saline from entering the contrast syringe 234, thereby preventing dilution of the contrast medium contained therein.

[0080] Once priming of the syringe 300 / 860b, the first length of tubing 232, and the single-use second tubing set 220 with saline is complete, the present system 200 can be filled with a small, precise volume of MR contrast medium according to the present method. In particular, the tubing segment 232 of the multi-use set 230 can be primed with contrast. To do so, the syringe 234 can be connected to the wipeable valve 250 and the valve assembly 240 can be turned to provide fluid communication between the third port 246 and the proximal port 242 of the valve assembly. The fluid injection system 804 can be controlled, either by its programming, its control buttons, or its manual knob 861b, to retract the plunger of the syringe 300 / 860b to draw the desired volume of MR contrast medium from the pre-filled syringe 234 (or other suitable container 234) through the wipeable valve 250, through the third and proximal ports 246, 242 of the valve assembly 240, and into the first length of tubing 232. As the MR contrast medium is drawn into the tubing segment 232, fluid communication with the distal port 244 is blocked by the valve assembly 240, thereby preventing saline in the single-use tubing set 220 from being drawn upstream, thereby maintaining the single-use tubing set 220 primed with saline. As Figure 4FAs shown, the first length of tubing 232 is filled at its distal end with a desired volume of contrast agent, for example, 5 ml of MR contrast agent in one embodiment, while the remaining upstream portion of its first tubing kit and the entire single-use tubing kit 220 are still perfused with saline.

[0081] Once the system 200 is filled with a saline flushing volume and the desired amount of MR contrast agent as described herein, the system 200 is ready for use with the fluid infusion system 804 according to an exemplary method to perform the desired infusion procedure. For example, in some embodiments, the valve assembly 240 may be configured to provide fluid communication between a proximal port 242 and a distal port 244, and the fluid infusion system 804 may be controlled via its programming, its control buttons, and / or its manual knob 861b to further extend the plunger into the barrel of the saline syringe 300 / 860b, thereby pressurizing the fluid within the fluid path defined by the syringe 300 / 860b, the tubing segment 232, the valve assembly 240, the single-use tubing kit 220, and the catheter to which the single-use tubing kit 220 is connected. In this way, the desired amount of MR contrast agent will be delivered from the tubing segment 232 through the valve assembly 240, the single-use tubing kit 220, and ultimately via the catheter to which the single-use tubing kit 220 is connected into the patient. This... Figure 4G The figure illustrates the desired amount of contrast agent being injected into the patient from the tubing segment 232 of the multiple-use tubing kit 230 through the single-use tubing kit 220 and via a catheter (not shown) already inserted into the desired blood vessel (note that although...). Figure 4G The distal end of tubing segment 220 is shown draining into a container, but in use, the distal end of tubing segment 220 is connected to a catheter fluidly connected to the patient's vascular system. According to some embodiments, the controller of the fluid infusion system may be configured to actuate an actuator to control valve assembly 240 to rotate an associated stopcock valve between various desired locations, depending on whether fluid communication is required between the third port 246 and proximal port 242 or between proximal port 242 and distal port 244, or to prevent fluid communication between any of the three ports, such as stopping the infusion protocol. In other embodiments, one or more one-way check valves or high-opening pressure valves may be used to control the flow of contrast agent and saline through proximal port 242, distal port 244, and / or third port 246 during perfusion and infusion procedures.

[0082] One purpose of the system 200 is to use the first length of tubing 232 of the multi-use set as a short-term volume retention container for delivering small volumes of contrast media to a patient. As described herein, the contrast media can be deployed in the form of a pre-filled syringe, bag, pouch, or vial with a male luer spike that can be connected to the multi-use tubing set 230 through the valve assembly 240. For example, the third port 246 of the valve assembly 240 will prevent any pressurized saline from the syringe 300 / 860b from entering the pre-filled syringe (or bag, pouch, or vial) and allow KVO (keep vein open) operation and saline flush through the fluid communication between the proximal port 242 and the distal port 244. The proximal port 242 of the valve assembly 240 will allow the contrast media to be drawn into the tubing segment 232 of the multi-use tubing set 230 and“prime the line” as the plunger of the saline syringe 300 / 860b is retracted. It should be clear that in certain embodiments, the tubing segment 232 can be implemented with a larger interior diameter (ID) and / or length such that it can hold 1-30 milliliters or even more of any volume of contrast media. Alternatively, a smaller ID of the tubing segment 232 can allow a smaller, more precise volume of contrast media to be held therein. Once the first length of tubing 232 is filled with the desired amount of contrast media, the plunger of the syringe 300 / 860b can be advanced to flush the system with saline and drive the contrast media into the single-use tubing set 220 and ultimately into the patient via the catheter. The plunger extension into the barrel of the syringe 300 / 860b also flushes the system and the patient’s blood vessels with saline, allowing the patient’s vasculature to acquire the contrast media. Although described primarily in the context of delivering contrast media herein, the present system 200 is equally well suited for use in delivering medications to a patient.

[0083] Regardless of use with single or dual syringe type injection systems, embodiments of the present system 200 with the multi-use set 230 and the wipeable valve 250 can be used with a pre-filled syringe 234 or a bag, pouch or vial loaded with contrast or medication with a spike inserted to access multiple doses of contrast for multiple injection protocols. In various embodiments, the fluid injection system 200 can be controlled from a scan room such as the scan room 814 of an MR suite. The injection system 200 can also employ wireless remote control so that its operator can control the injection procedure remotely and with regard to patient safety. The system is also readily adapted for use with both syringes of a dual head injection system. For example, in addition to using a saline syringe as described above, the present system can use a contrast syringe of a dual head injection system to draw a desired amount of contrast (or medication) or more contrast into the tubing segment 232 of the multi-use set 230. In this regard, the selected contrast syringe can have a smaller diameter than the saline syringe. Finally, the present system is also readily adapted for use with a cassette-based injection system in place of a syringe-based injection system. In this regard, the present system can be implemented as a cassette designed to be loaded in and operated by such a cassette-based injection system. One or more stopcock valves can be used, for example, to allow continuous supply of saline to the main syringe (i.e., for filling and refilling the main syringe).

[0084] Referring now to Figures 5-12 , a schematic diagram illustrating various non-limiting embodiments of a system 200 according to one aspect of the present disclosure is shown. Figures 5-12 The exemplary embodiments of the system 200 in Figures 4A-4G may be the same as or similar to the system 200 shown in

[0085] Referring to Figure 5 , Figure 6 , Figure 8A and Figure 8Bembodiment of a system 200 for use with a fluid injection system, including a first tubing set 230, which can further include a first length of tubing 232 and a second length of tubing 236. As described above, the first tubing set 230 can be a multi-use tubing set 230, such that the set 230 remains sterile and suitable for multiple injection procedures for multiple patients without contaminating the multi-use components. The first length of tubing 232 can be sized to hold 30 milliliters or less of fluid. For certain patients and / or use cases, the first length of tubing 232 can be designed to hold a fluid volume ranging from 0.1 milliliters and 15 milliliters. However, the appropriate size and volume limitations of the tubing ultimately depend on the use case in which the system 200 is applied, such as the indicated treatment and the needs of the individual patient. Thus, the first length of tubing and / or the tubing set 230 can also be sized and configured to hold larger or smaller volumes of fluid. For example, the first length of tubing 232 can be designed to hold a volume ranging from 0.1 milliliters to about 5 milliliters of fluid, or even a volume ranging from 0.1 milliliters to 0.5 milliliters of fluid, for imaging procedures for pediatric patients.

[0086] In some non-limiting embodiments, the first length of tubing 232 of the multi-use set 230 can be made of a translucent polymeric material, such that the fluid in the first length of tubing is visible to a user and / or sensors of the fluid injection system 804. This visibility is primarily used to allow for accurate measurement of the medical fluid F as it is withdrawn from the syringe 234 into the system 200 and / or held in the multi-use set 230. It is also contemplated that virtually any tubing of the system 200, including but not limited to the multi-use set 230 and the single-use set 220, can also be made of a translucent or transparent material. The inclusion of translucent tubing provides additional configurations and opportunities to hold and / or measure the medical fluid prior to injection. Furthermore, it provides an additional safety measure by allowing a user of the fluid injection system and / or sensors to ensure that the proper functioning of the system is maintained. To further assist the user or the fluid injection system in measuring the fluid, the first length of tubing 232 (or other suitable tubing portion of the system) can include markings, such as graduated volume demarcations, configured to provide a volume measurement of the fluid within the first tubing portion 232 or other given length of tubing. The markings can be read by a user or one or more sensors in communication with a controller of the injection system to begin or stop a priming or fluid delivery step based on the volume of medical fluid drawn into the first length of tubing 232 according to the methods of using the system 200.

[0087] In some non-limiting embodiments, where system 200 is used with a fluid injection system, such as fluid injection system 804, the fluid injection system can include at least one measuring sensor for measuring the volume of fluid, such as liquid contrast medium, drawn into the first length of tubing 232. The measuring sensor can be configured to communicate with a controller of the fluid injection system when a predetermined volume of liquid contrast medium is drawn into or pushed into the first length of tubing.

[0088] Figure 5 , 6 Figures 8A and 8B also show a first connector member 233, which can be located at a proximal end of the first length of tubing 232. The first connector member 233 can be configured to connect to a syringe 300, which can be intended to be connected to the fluid injection system 804. Thus, in some non-limiting embodiments of system 200, the first connector member 233 can connect the syringe 300 / 860b, which can be a manual syringe, an automated injector, or a syringe of a fluid injection system.

[0089] With continued reference to Figure 5 , 6 Figures 8A and 8B, the first length of tubing 232 and the second length of tubing 236 can include a valve assembly 240 disposed therebetween, such that the valve assembly 240 is located at a distal end of the first length of tubing 232. The valve assembly 240 can include a proximal port 242, a distal port 244, and a third port 246. As shown in the example embodiment, a second connector member 224a, which can be connected to the proximal port 242, can further connect the distal end of the first length of tubing 232 to the proximal port 242. As further shown, a third connector member 224b can be connected to the distal port 244, and a fourth connector member 224c connects the first wipeable valve 250 and the second length of tubing 236 to the third port 246. As noted above, the third port 246 is designed to connect to the wipeable valve 250, and this connection can be made by the third connector member 224c. In some non-limiting embodiments, as noted above, one or more of the first connector member 233, the second connector member 224a, the third connector member 224b, and the fourth connector member 224c can include a one-way check valve and / or a luer connector, or a combination thereof. In some non-limiting embodiments, the connector members can be contained within or can be part of the valve, including the connector members associated with the valve assembly 240.

[0090] According to example embodiments, a container 234 containing a medical fluid F, such as a contrast medium, can be removably connected to the first wipeable valve 250. Once the relevant components of the system 200 have been assembled, the valve assembly 240 can selectively provide fluidic connections between the proximal port 242, the distal port 244, and the third port 246, such that perfusion, flushing, and / or fluid measurement and delivery can be performed using the system 200. In various embodiments, the valve assembly 240 can be manually actuated or actuated by an actuator in response to one or more signals sent from a controller of the fluid injection system. For example, in non-limiting embodiments in which the syringe 300 / 860b is provided containing a flushing agent, such as saline, the valve assembly 240 provides fluidic connections between the proximal port 242 and the distal port 244. The plunger 320 is actuated by the fluid injection system, which then pushes the diluent through the second tubing set 220 to flush the administration line 220. In certain embodiments, the actuation of the plunger 320 can be manual actuation, in which the syringe 300 / 860b is a manual syringe.

[0091] With reference to Figure 8A and 8B non-limiting embodiments of the system 200 are associated with a fluid injection system, such as the fluid injection system 804, and the connector member 233 is connected to a syringe 300 / 860b of the fluid injection system, actuation of the fluid injection procedure can be driven by the piston. In such embodiments, the fluid injection system 804 can be programmed or controlled to drive the valve assembly 240 and / or the piston associated with the syringe 300 / 860b to retract the plunger 320, thereby drawing a predetermined volume of fluid from the container 234 into the first length of tubing 232. In other embodiments, the syringe 234 can be a manual syringe, which can be manually add a desired volume of contrast fluid to the first length of tubing 232. For example, the syringe 234 can include one or more stops associated with defined volumes of fluid, such as 0.1 milliliters or 0.5 milliliters, and a user can move the piston of the syringe 234 the number of stops associated with the desired volume of contrast for the procedure. In other embodiments, the syringe or container 234 can include a dial, such as a threaded plunger, in which the distance of rotation of the dial is associated with a volume of contrast, and a user can rotate or otherwise move the dial the number of movements associated with the desired volume of contrast for the procedure. Other methods of precisely dispensing a desired volume of contrast from the container 234 can be contemplated.

[0092] In some embodiments, as Figure 5 and Figure 6As shown, the third connector 224b of the system 200 can connect the proximal end of the second tubing set 220 to the distal port 244 of the valve assembly 240. In some non-limiting embodiments, the second tubing set 220 can be a medication administration line or a single use set 220, as described herein. The tubing set 220 can include a one-way check valve 222 located therein, for example at the distal end of the tubing set 220, to allow fluid to flow therefrom in a single direction, i.e., fluid flow to the patient, while proximal fluid flow is blocked to prevent contamination of the multi-patient portion of the system. The distal end of the tubing set 220 can also be connected to a catheter, such as catheter 260, or another suitable connector of a patient line for delivery of the medical fluid F to the patient.

[0093] In some non-limiting embodiments, for example Figure 5 , Figure 6 and Figure 8A as shown in the illustrated embodiment, the container 234 containing the medical fluid F can be a second syringe 234. In such example embodiments, the valve assembly 240 can provide a fluid connection between the third port 246 and the proximal port 242. The second syringe 234 can then selectively control fluid flow between the second syringe 234 and the first length of tubing 232 such that a measured volume of fluid is allowed to flow from the second syringe 234 to the first length of tubing. Similar to the syringe 300 / 860b, the second syringe 234 can be a manual syringe, or in embodiments where the system 200 is associated with a fluid infusion system, the second syringe 234 can be a syringe that is connected to and operated by the fluid infusion system.

[0094] In some non-limiting embodiments, as Figure 5 and Figure 6 shown, the system 200 can include an additional syringe, such as a third syringe, for example the micro-syringe 600. To accommodate the micro-syringe 600, an additional connector member 224d can be provided between the third port 246 and the syringe 234. As Figure 5 shown, the micro-syringe 600 can be removably connected to the additional connector member 224d and the third port 246. In such embodiments, the medical fluid can be withdrawn from the container 234 through the syringe 300 / 650b in a priming or infusion procedure. For example, when a precise small volume of medical fluid is to be withdrawn from the syringe 234, the micro-syringe 600 can be used to accurately measure the desired volume from the syringe 234 and then used to infuse the desired volume into the length of tubing 232 through the valve assembly 240. When use of the micro-syringe 600 is not desired or indicated for a particular procedure, the micro-syringe 600 can be disconnected from the additional connector member 224d and the additional connector member can receive a cap C.

[0095] In embodiments where the container 234 is implemented as a syringe, medical fluid can also be pushed out of the container 234 as shown. Figure 5 Alternatively, the container 234 can be disconnected from the system 200 and the wipe valve 250 can receive a cap to maintain pressure of the system 200. In such embodiments, the micro-syringe 600 can provide medical fluid for a priming and / or an injection procedure such that a measured volume of medical fluid is allowed to flow from the micro-syringe 600 to the first length of tubing 232. As shown, Figure 6 In cases where both the micro-syringe 600 and the container 234 are provided, the connector members 224a / 224b / 224c and the additional connector member 224d are configured to selectively control fluid flow between the container 234, the micro-syringe 600, and the first length of tubing 232. Thus, a measured volume of medical fluid is allowed to flow from the container 234 to the first length of tubing 232.

[0096] Referring now to Figure 7 , an exemplary embodiment of the second syringe 234 is shown as a pulse syringe 700. The pulse syringe 700 can include a dispenser piston 702 within the barrel of the pulse syringe 700 for dispensing a controlled and precise low dose of medical fluid. The dispenser piston 702 can be located at the distal end of a plunger assembly 704 of the pulse syringe. The dispenser piston 702 can also be enclosed by a cap 706 of the plunger assembly 704. The cap 706 can be made of rubber or another suitable elastomer. The pulse syringe 700 can also include a solenoid 708, actuation of which can drive an engagement piston 710. The engagement piston 710 thereby engages the rubber cap 706 of the plunger assembly, dispensing a controlled dose of medical fluid.

[0097] The pulse syringe 700 is thus configured to selectively control fluid flow from the second syringe 234 to the first length of tubing 232 through the valve assembly 240 by delivering a predetermined amount of medical fluid a predetermined number of times. Exemplary non-limiting embodiments of the pulse syringe 700 can be associated with the fluid injection system 804 described herein. The fluid injection system 804 can be programmed or controlled to actuate the solenoid 708, thereby actuating the dispensing piston 702 to deliver a predetermined volume of medical fluid a predetermined number of times (pulses). In some non-limiting embodiments, the predetermined volume of medical fluid can be as little as 0.1 milliliters per pulse or as much as 1 milliliter per pulse. It is contemplated that the predetermined volume can be any volume for which the system 200 has a volume capacity. Likewise, the predetermined number of pulses can be any number of pulses for which the system 200 has a capacity. For example, to achieve a volume of 5 milliliters of medical fluid held in the system 200, the pulse syringe can be pulsed 5 times, with 1 milliliter dispensed each time.

[0098] In some non-limiting embodiments, as Figure 8BAs shown, system 200 can further include a dial 790 between the container 234 and the first length of tubing 232. Dial 790 can selectively control fluid flow between the container 234 and the first length of tubing 232 when the valve assembly 240 provides a fluid connection between the third port 246 and the proximal port 242, allowing for precise measured volumes of medical fluid to flow from the container to the first length of tubing. Dial 790 can be configured to only allow a predetermined volume of fluid to be withdrawn from the container 234 with each rotation or "click" (partial rotation or linear movement increment, for example, represented by an audible or tactile click) of the dial.

[0099] Still referring to Figure 8B , the container 234 containing medical fluid is a pouch, bag, bottle, or other vessel that can be configured to receive a spike. System 200 can include a spike 720 connected to a swabbable valve 250 that is connected to the third port 246. In Figure 8B , the container 234, shown as a liquid bag, receives the spike 720 and is in fluid connection with the valve assembly 240. In such exemplary embodiments, fluid can be withdrawn from the container 234 through the syringe 300 / 650b or through another means as described herein. For example, as Figure 6 shown, system 200 can include a micro-syringe 600 connected to the additional connector member 224d. In Figure 8B embodiments shown, the dial 790 can be used to withdraw medical fluid from the container 234. In other embodiments, another syringe or device can be provided to withdraw or push medical fluid from the container 234.

[0100] Referring now to Figures 9A-11 , a non-limiting embodiment of system 200 is shown, wherein the system includes a saline bypass line, illustrated as a third length of tubing 238. In exemplary embodiments, the syringe 860 can be a dual syringe system, such as the dual syringe system of the fluid injection system 804. In such embodiments, the container containing medical fluid can be a prefilled component 900 positioned between the first length of tubing and the valve assembly 240. As Figure 9A shown, the proximal end of the third length of tubing 238 is connected to the syringe 860b and the distal end of the third length of tubing is connected to the second tubing set 220 at the valve assembly 240. In these exemplary embodiments, the bypass line 238 and the first length of tubing 232 are in parallel, and both can ultimately deliver fluid to a patient through a delivery line such as the second set 220.

[0101] Bypass line 238 is configured to deliver flush fluid to second tubing set 220 and the patient. Upon actuation of the piston / plunger 320 of syringe 300 / 860b, diluent is delivered through the first length of tubing, thereby actuating the pre-filled component 900. Actuation of the pre-filled component 900 pushes the medical fluid through the first length of tubing to the second tubing set 220 and ultimately to the patient. Embodiments of the saline bypass line, such as bypass line 238, in system 200 provide the advantage of avoiding fluid communication between multiple medical fluids, such as diluent and drug. For example, avoiding fluid communication between saline and contrast prevents unwanted dilution of the contrast, which can also allow for lower volumes of contrast.

[0102] Referring to Figure 10 , system 202 can also include a three-way valve between the connector member 233 and the distal end of each bypass line 238 and the first length of tubing 232 to control fluid flow from the syringe 300 / 860b to the bypass line 238 and / or the first length of tubing 232. As shown in Figure 10 , the three-way valve can be a stopcock valve 952, which can be associated with a fluid injection system 804. The fluid injection system 804 can be configured to actuate the stopcock valve to complete the fluid connection between the syringe 300 / 860b and the first length of tubing 232 and the pre-filled component (i.e., the dual-sided plunger 950 of the Figure 10 . The stopcock valve associated with the fluid injection system 804 can also be implemented in place of other valves / valve assemblies of the present disclosure, such that system 200 can be at least partially or fully automated.

[0103] In some non-limiting embodiments, the container 234 containing the medical fluid can be any suitable pre-filled component, such as a syringe with a dual-sided plunger 950 as shown in Figure 10 , a rolling diaphragm 960 as shown in Figure 11 , or a cartridge 970 as shown in Figure 12 . The pre-filled component can be manufactured with a precise dose of medical fluid, such as contrast, or can be filled by a user prior to implementation in system 200. For embodiments of system 200 that are applied to a fluid injection system 804, it is desirable to use a pre-filled component (e.g., dual-sided plunger 950, rolling diaphragm 960, cartridge 970, etc.). In some embodiments, the pre-filled component can include a computer-readable medium, such as a barcode, QR code, RFID tag, text, symbol, etc., and the fluid injection system can include a scanner or other sensor capable of reading the barcode and transmitting data about the pre-filled component to a controller associated with the fluid injection system 804 or an injection protocol management system. The controller can use this data in conjunction with other input data to execute an appropriate perfusion / injection procedure. For example, Figures 9A-12The pre-filled component embodiments shown in the middle allow for the use of smaller amounts of tubing when providing larger volumes of medical fluid. Instead of providing a lengthened length of tubing, a pre-filled component can be provided to occupy less linear space in the system 200.

[0104] Referring now to Figure 12 , a non-limiting embodiment of a system 200 is shown, including a pre-filled component, wherein the pre-filled component is implemented as a cassette 970 containing a pre-filled bottle or syringe 972. In this exemplary embodiment, the system 200 can be the same or similar to the embodiments exemplified in Figure 5 and Figure 6 and can further include an air sensor 730. The air sensor 730 can be located on the second length of tubing 236 and / or on the administration line 220. The air sensor can be configured to detect air in the system 200 and can communicate detection of air to a controller of the fluid injection system. When air is detected in the system 200, the fluid injection system can be controlled to begin a flushing procedure or to stop a priming or injection procedure.

[0105] Referring now to Figure 13 , a sequence diagram is shown of a method 1300 of using the system 200 applied to a fluid injection system 804. In some non-limiting embodiments, the method steps for using a fluid injection system 1302 can include providing a suitable fluid injection system and various desired components of the system 200, such as those discussed in detail above.

[0106] For exemplary purposes, a fluid injection system can include a housing, at least one syringe, at least one drive member, and at least one controller programmed or configured to control actuation of the at least one drive member, and an administration line according to any of the various embodiments of the system described herein. The fluid injection system can further include a first length of tubing having a proximal end and a distal end, and a first connector member located at the proximal end of the first length of tubing. The first connector member can be configured to connect to the at least one syringe of the fluid injection system, and a valve assembly can be located at the distal end of the first length of tubing. The valve assembly can include a proximal port, a distal port, and a third port. A second connector member can connect the distal end of the first length of tubing to the proximal port. A third connector member can be connected to the distal port and can be configured to connect to a proximal end of the administration line. A fourth connector member can connect the first wipeable valve to the third port.

[0107] The fluid injection system can be provided in any suitable environment to perform a desired injection procedure or therapy. For example, if the desired procedure is to inject contrast media prior to an imaging procedure, the fluid injection system can be provided in the medical imaging suite 800 described above.

[0108] InFigure 13 In method step 1304, the method may further include perfusing at least one syringe by pushing a diluent through at least one syringe. In method step 1306, the method may include connecting a drug delivery line to the proximal port of a third connector member and a valve assembly. In method step 1308, the method may further include connecting the proximal end of a first-length tubing to at least one syringe of the fluid infusion system. In this state, after the connections in method steps 1306 and 1308 have been completed, the fluid infusion system may be ready to perform a saline perfusion procedure. Therefore, in method step 1310, the method may include perfusing the fluid infusion system by actuating at least one drive member and pushing flushing fluid (e.g., saline) from at least one syringe through the first-length tubing and through the drug delivery line.

[0109] like Figure 13 As shown in method step 1312, the method may include connecting a container containing a medical fluid (such as MR imaging media) to a first wipeable valve. However, it should be understood that the connection of the container, which may be a syringe, bag, bottle, box, or any other suitable container, may also be performed prior to the saline infusion procedure of method step 1310, depending on the container used and the desired infusion procedure. As shown in method step 1314, once the fluid infusion system has been infused and the desired medical fluid has been introduced into the system, at least one actuating member may be actuated to draw a desired dose or volume of medical fluid into a tubing of a first length.

[0110] In some non-limiting embodiments, as shown in method step 1316, the contrast medium or other medical fluid can be measured in the various ways described above when fluid enters the first length of tubing. Additionally or alternatively, in method step 1318, the medical fluid may be held within the system until the injection procedure is performed. In some non-limiting embodiments, the fluid may be measured additionally or alternatively while held by the system. In method step 1320, when injection is required, at least one actuating member can be actuated to push a dose of the medical fluid from the first length of tubing through the drug delivery line to the patient.

[0111] Examples of various use cases for this system include adaptation to imaging modalities such as magnetic resonance imaging (MRI), nuclear medicine (including positron emission tomography (PET)), computed tomography (CT), and angiography. Three such examples are provided below.

[0112] While several examples of devices, systems, related components, and methods for measuring precise doses and / or maintaining precise doses of medical fluids used in fluid infusion systems are shown in the drawings and described in detail above, other aspects will readily occur to those skilled in the art and are intended to be encompassed in the scope of the present disclosure. The foregoing description is therefore intended to be illustrative only, rather than limiting. Various embodiments of the present disclosure described above are defined by the appended claims, and all changes that come within the meaning and range of equivalents of the claims are to be embraced within their scope.

[0113] While the above system, method, and various embodiments and aspects thereof have been described in detail based upon what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the disclosure is not limited to the disclosed embodiments or aspects, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the described system. For example, it is to be understood that the disclosure contemplates that one or more features of any embodiment or aspect can be combined with one or more features of any other embodiment or aspect. In fact, any feature of the disclosure can be combined with any other feature of the disclosure in a manner that is within the scope of the disclosure.

Claims

1. A system for delivering a fluid to a patient, the system comprising: a first tubing set having a first length of tubing and a second length of tubing, the first and second lengths of tubing each having a proximal end and a distal end; a first connector member disposed at the proximal end of the first length of tubing, the first connector member configured to connect to a flush syringe; and a valve assembly disposed at the distal end of the first length of tubing, the valve assembly comprising: a proximal port, a distal port, and a third port; a second connector member connecting the distal end of the first length of tubing to the proximal port; a third connector member connected to the distal port; and a fourth connector member connecting a first swabbable valve and the second length of tubing to the third port, wherein a container containing a medical fluid is removably connected to the first swabbable valve; and wherein the valve assembly selectively provides fluid connection between the proximal port, the distal port, and the third port.

2. The system of claim 1, wherein, the third connector member connected to the distal port is connected to a proximal end of a second tubing set, wherein the second tubing set further comprises a one-way check valve configured to allow fluid flow toward a distal end of the second tubing set.

3. The system of claim 2, wherein, the second tubing set is an administration line connected to a catheter configured to be fluidly connectable to a patient.

4. The system of claim 3, wherein, the administration line is a single-use set.

5. The system of any one of claims 1 to 4, wherein, the first tubing set and the valve assembly are a multi-use set such that they remain sterile and suitable for use with more than one patient.

6. The system of claim 2, wherein, the first connector member is connected to the flush syringe, and the flush syringe is a manual syringe, an automatic injector, or a syringe connected to a fluid injection system.

7. The system of claim 6, wherein, the flush syringe contains a flushing fluid; and wherein the valve assembly provides fluid connection between the proximal port of the first tubing set and the distal port of the second tubing set, and actuation of a plunger or piston of the flush syringe pushes the flushing fluid through the second tubing set to flush the administration line.

8. The system of any one of claims 1 to 7, wherein, at least one of the first, second, third, and fourth connector members comprises at least one of a one-way check valve and a luer connector.

9. The system of any one of claims 1 to 9, wherein, the first length of tubing is sized to hold the medical fluid in a volume of up to about 30 milliliters.

10. The system of claim 9, wherein, the first length of tubing is sized to hold the medical fluid in a volume ranging from 0.1 milliliters to about 15 milliliters.

11. The system of claim 9, wherein, the first length of tubing is sized to hold the medical fluid in a volume ranging from 0.1 milliliters to about 5 milliliters.

12. The system of any one of claims 1 to 11, wherein, the first length of tubing is made of a translucent polymeric material such that the medical fluid in the first length of tubing is visible to a user and / or a sensor of a fluid injection system.

13. The system of any one of claims 1 to 12, wherein, the first length of tubing further comprises a marker configured to provide a volumetric measurement of an amount of the medical fluid in the first length of tubing.

14. The system of any one of claims 1 to 13, further comprising a volume control element disposed between the container containing the medical fluid and the first length of tubing; and wherein, the valve assembly provides fluid connection between the third port and the proximal port, and the volume control element selectively controls fluid flow between the container and the first length of tubing such that a measured volume of the medical fluid flows from the container into the first length of tubing.

15. The system of any one of claims 1 to 13, wherein, the container containing the medical fluid is a second syringe; and wherein the valve assembly provides fluid connection between the third port and the proximal port, and the second syringe selectively controls fluid flow between the second syringe and the first length of tubing such that a measured volume of the medical fluid flows from the second syringe into the first length of tubing.

16. The system of any one of claims 1 to 13, wherein, a spike connected to a wiper valve of the third port, wherein the container containing the medical fluid is a pouch, a bag, a bottle, or another vessel configured to receive the spike; and wherein the container is fluidly connected to the valve assembly when the container receives the spike.

17. The system of any one of claims 1 to 16, wherein, the first connector member is connected to the flush syringe that is connected to a fluid infusion system, and the fluid infusion system is programmed or controlled to actuate a piston of the flush syringe to draw a predetermined volume of the medical fluid from the container into the first length of tubing.

18. The system of claim 15, wherein, the second syringe comprises a pulse syringe configured to selectively control fluid flow from the second syringe to the first length of tubing by delivering a predetermined volume of the medical fluid from the pulse syringe into the first length of tubing a predetermined number of times.

19. The system of claim 18, wherein, the pulse syringe is connected to the fluid infusion system, and the fluid infusion system is programmed or controlled to actuate a piston of the pulse syringe to deliver the predetermined volume of the medical fluid from the pulse syringe into the first length of tubing the predetermined number of times.

20. The system of claim 18 or 19, wherein, the predetermined volume of the medical fluid ranges from 0.1 milliliter to about 1 milliliter.

21. A system for delivering a fluid to a patient, the system comprising: a first length of tubing having a proximal end and a distal end; a first syringe connected to the proximal end of the first length of tubing; a valve assembly disposed at the distal end of the first length of tubing, the valve assembly comprising: a first port, a second port, and a third port; a connector member connected to each of the first port, the second port, and the third port; and a first wiper valve connected to the third port; wherein the second port is connected to a proximal end of a second tubing set and a catheter configured to be fluidly connectable to a patient, wherein the distal end of the first length of tubing is connected to the first port, wherein a container containing a medical fluid is removably connected to the valve assembly.

22. The system of claim 21, wherein the system further comprises: a second syringe; and an additional connector member between the third port and the second syringe; wherein the second syringe is removably connected to the additional connector member and the third port, and wherein the connector member and the additional connector member are configured to selectively control fluid flow between the container, the second syringe, and the first length of tubing such that a measured volume of the medical fluid is permitted to flow from the container to the first length of tubing or from the second syringe to the first length of tubing.

23. The system of claim 22, wherein, the container is disconnected from the swabbable valve and the swabbable valve receives a valve cap; or the second syringe is disconnected from the additional connector member and the additional connector member receives a connector member cap.

24. The system of any one of claims 21 to 23, wherein, the system further comprises a third length of tubing having a proximal end and a distal end, and the container includes a pre- fill component disposed between the first length of tubing and the valve assembly, wherein the proximal end of the third length of tubing is connected to the first syringe and the distal end of the third length of tubing is connected to the second tubing set, wherein the third length of tubing is a bypass line configured to deliver a flushing fluid to the second tubing set and a patient, and wherein the flushing fluid is delivered through the first length of tubing and the pre- fill component is actuated to deliver the medical fluid through the first length of tubing to the second tubing set and the patient.

25. The system of claim 21, wherein, the first length of tubing further comprises a syringe having a dual-sided plunger.

26. The system of claim 21, wherein, the first length of tubing further comprises a rolling diaphragm.

27. A fluid injection system, the fluid injection system comprising: a housing, at least one syringe, at least one drive member, and at least one controller programmed or configured to actuate the at least one drive member; a medication line; a first length of tubing having a proximal end and a distal end; a first connector member disposed at the proximal end of the first length of tubing, the first connector member configured to connect to the at least one syringe of the fluid injection system; and a valve assembly disposed at the distal end of the first length of tubing, the valve assembly comprising: a proximal port, a distal port, and a third port; a second connector member connecting the distal end of the first length of tubing to the proximal port; a third connector member connecting the distal port to a proximal end of the medication line; and a fourth connector member connecting a first swabbable valve to the third port; the first swabbable valve removably connecting a container containing a medical fluid to the third port, wherein the valve assembly selectively provides fluid connections between the proximal port, the distal port, and the third port; and wherein the medical fluid is a liquid contrast agent and the at least one syringe is filled with a flushing fluid.

28. The fluid injection system of claim 27, wherein, The valve assembly provides fluid connection between the proximal port and the distal port, and actuation of the at least one drive member pushes the flush fluid from the at least one syringe through the administration line to flush the administration line.

29. The fluid injection system of claim 27 or 28, wherein, The valve assembly also provides fluid connection between the third port and the proximal port, such that a volume of the liquid contrast media is drawn into the first length of tubing by actuation of the at least one drive member; or wherein the container is a second syringe, and a volume of the liquid contrast media is pushed into the first length of tubing by actuation of a plunger of the second syringe.

30. The fluid injection system of any of claims 27 to 29, wherein, The valve assembly also provides fluid connection between the proximal port and the distal port, such that a dose of the liquid contrast media is pushed from the first length of tubing through the administration line and delivered to the patient by actuation of the at least one drive member.

31. The fluid injection system of claim 29, further comprising a measurement sensor configured to measure a volume of the liquid contrast media drawn into the first length of tubing; and wherein, The measurement sensor is configured to communicate with the controller when a predetermined volume of the liquid contrast media is drawn into or pushed into the first length of tubing.

32. The fluid injection system of any of claims 27 to 31, wherein, The fluid injection system further comprises an air sensor disposed on a second length of tubing and / or the administration line; and wherein the air sensor is configured to detect air in the second length of tubing and / or the administration line and communicate detection of air to the controller of the fluid injection system.

33. A method of using a fluid injection system, the method comprising: providing a fluid injection system, the fluid injection system comprising: a housing, at least one syringe, at least one drive member, and at least one controller programmed or configured to actuate the at least one drive member; an administration line; a first length of tubing having a proximal end and a distal end; a first connector member disposed at the proximal end of the first length of tubing, the first connector member configured to connect to the at least one syringe; and a valve assembly disposed at the distal end of the first length of tubing, the valve assembly comprising: a proximal port, a distal port, and a third port; a second connector member connecting the distal end of the first length of tubing to the proximal port; a third connector member connected to the distal port and configured to connect to a proximal end of the administration line; and a fourth connector member connecting a first wipeable valve to the third port; priming the at least one syringe by pushing a flush fluid into the at least one syringe; connecting the administration line to the third connector member and the proximal port of the valve assembly; connecting the proximal end of the first length of tubing to the at least one syringe of the fluid injection system; actuating the at least one drive member to draw a volume of the liquid contrast media into the first length of tubing; and actuating the at least one drive member to push a dose of the liquid contrast media from the first length of tubing through the administration line and to the patient. priming the fluid infusion system by actuating the at least one drive member and pushing irrigation fluid contained in the at least one syringe through the first length of tubing and through the administration line; connecting a container containing a medical fluid to the first wipeable valve; actuating the at least one drive member to draw a volume of the medical fluid into the first length of tubing; and actuating the at least one drive member to push the volume of the medical fluid from the first length of tubing through the administration line and to a patient.

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