A system and method for fluid delivery that uses tubing to hold the contrast medium before flushing with saline solution.

Abstract

A system for the precise delivery of small amounts of medical fluid to a patient is described. The system includes a tubing set having a first-length tube and a second-length tube, a first connector member positioned at the proximal end of the first-length tube configured to connect to a syringe, and a valve assembly positioned at the distal end of the first-length tube. The system utilizes a section of the first-length tube to measure and contain small amounts of medical fluid for flushing into the patient's body through the valve assembly and the second-length tube.

Description

Technical Field

[0004] ,

[0003] , ,

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 457,940, filed Apr. 7, 2023, the disclosure of which is incorporated herein by reference in its entirety.

[0002] This disclosure relates to devices, systems, and methods related to medical devices for use in delivering medical fluids to patients, particularly to devices, systems, and methods for measuring precise amounts and / or small amounts, holding precise amounts and / or small amounts, and / or delivering precise amounts and / or small amounts of medical fluids using a fluid injection system.

Background Art

[0003] Infusion systems, such as fluid infusion systems (e.g., medical fluid delivery systems), can be used by medical personnel in medical diagnostic procedures and / or medical treatment procedures. For example, medical personnel can use a fluid infusion system to inject one or more medical fluids into a patient. Fluid infusion systems can be used for the pressure infusion of medical fluids, such as radiographic contrast materials (e.g., contrast agents, contrast media), and / or flushing agents such as saline, in medical imaging procedures such as angiography (CV), computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), and positron emission tomography (PET). Fluid infusion systems may be used to deliver medical fluids or liquid pharmaceuticals to patients during other procedures and / or treatments, including nuclear medicine imaging, molecular imaging, radiopharmaceutical injection, and cardiovascular regional therapy. In some cases, fluid infusion systems are designed to deliver a certain amount of medical fluid to a patient at one or more flow rates.

[0004] In medical treatment or procedures, the amount of medical fluid that must be delivered to a patient is measured by volume, or by dose. In some cases, accurate measurement of the dose delivered to the patient is crucial for proper imaging or treatment, and for avoiding adverse reactions or complications to the patient's health. Improvements in imaging systems and contrast agents also allow for smaller doses of contrast medium to be used in procedures, or require less, while still achieving accurate and detailed images. For example, imaging systems are becoming increasingly sensitive to contrast agents, predictive artificial intelligence algorithms allow for smaller amounts of contrast medium to be used, and contrast agents are being developed with higher degrees of relaxation. These factors allow for smaller amounts of contrast medium to be used during procedures. However, known fluid infusion systems often involve larger injectors and larger volume syringes, and do not provide adequate volume control or precise measurement of the accurate dose directed for delivery to the patient. For example, an MRI procedure for the average adult male may have previously required more than 30 mL of liquid contrast medium for accurate imaging. In light of improvements in imaging systems and contrast agents, an average MRI procedure for an average adult male may require less than 30 mL, or even less than 20 mL, of contrast medium. In some cases, the dose for an average adult male may be as little as 8 mL to 15 mL. In some cases, the dose for a pediatric patient may be as little as 1 mL to 2 mL of contrast medium. In some cases, certain procedures or treatments may require only a precise dose of medical fluid, such as 0.1 mL to 0.5 mL.

[0005] Furthermore, the use of excessive amounts of contrast medium can result in significant costs for both healthcare providers and, ultimately, patients. Therefore, volume contributes significantly to the costs associated with the manufacture, distribution, and use of contrast medium, and limiting the volume-based use of contrast medium is crucial for limiting costs for healthcare workers and patients.

[0006] In consideration of the above, there is a need for devices, systems, and methods that use fluid injection systems to measure precise volumes and / or small quantities, to hold precise volumes and / or small quantities of medical fluid, and / or to deliver precise volumes and / or small quantities of medical fluid. [Overview of the project]

[0007] Accordingly, aspects of the present disclosure relate to non-limiting embodiments of devices, systems, and methods for measuring precise volumes and / or small amounts, holding precise volumes and / or small amounts, and / or delivering precise volumes and / or small amounts of medical fluid using a fluid injection system. [Means for solving the problem]

[0008] According to one aspect of the present disclosure, a system for use in delivering fluid to a patient includes a first tubing set having a first length tubing and a second length tubing, each having a proximal and distal end. A first connector member is positioned at the proximal end of the first length tubing and is configured to connect to a flushing syringe, and a valve assembly is positioned at the distal end of the first length 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 tubing to the proximal port. A third connector member connects to the distal port. A fourth connector member connects the first swabable valve and the second length tubing to the third port. The system also includes a container for containing medical fluid, which is detachably connected to the first swabable valve. The valve assembly selectively provides fluid connections between the proximal port, the distal port, and the third port.

[0009] According to another aspect of the present disclosure, a system for use in delivering fluid to a patient includes a tube of a first length having a proximal end and a distal end, a first syringe connected to the proximal end of the tube of the first length, and a valve assembly positioned at the distal end of the tube of the first length. The valve assembly includes a first port, a second port, and a third port, connector members connected to the first port, the second port, and the third port, respectively, and a first swabable valve connected to the third port. The second port is connected to the proximal end of a second tube set and to a catheter configured to deliver fluid to a patient. The distal end of the tube of the first length is connected to the first port, and a container for containing medical fluid is detachably connected to the valve assembly.

[0010] According to another aspect of the present disclosure, a fluid infusion system includes a housing, at least one syringe, at least one drive member, and at least one controller programmed or configured to control the operation of at least one drive member. The fluid infusion system further includes a dosing line, a tube of a first length having a proximal end and a distal end, and a first connector member positioned at the proximal end of the tube of the first length, the first connector member being configured to connect to at least one syringe of the fluid infusion system. Furthermore, the system includes a valve assembly positioned at the distal end of the tube of the first length. The valve assembly includes a proximal port, a distal port, and a third port, a second connector member connecting the distal end of the tube of the first length to the proximal port, a third connector member connecting the distal port to the proximal end of the dosing line, and a fourth connector member connecting a first swabable valve to the third port. A first swabable valve removably connects a container for medical fluid to a third port, and the valve assembly selectively provides fluid connections between the proximal port, the distal port, and the third port. The medical fluid is a liquid contrast medium, and at least one syringe is filled with flushing fluid.

[0011] According to another aspect of the present disclosure, a method of using a fluid infusion system includes the step of providing a fluid infusion system. The method further includes priming at least one syringe of the system by pushing a flushing fluid into at least one syringe; connecting a dosing line to a third connector member and the proximal port of a valve assembly; and connecting the proximal end of a first-length tube to at least one syringe. Furthermore, the method includes priming the fluid infusion system by operating at least one drive member to pass the flushing fluid contained in at least one syringe through the first-length tube and through the dosing line. The method further includes connecting a container for medical fluid to a first swabable valve; operating at least one drive member to draw a certain amount of medical fluid into the first-length tube; and operating at least one drive member to push a certain amount of medical fluid from the first-length tube through the dosing line to a patient.

[0012] Herein, non-limiting exemplary examples of embodiments of the present disclosure are described in the following numbered clauses.

[0013] Section 1: A system for use in delivering fluid to a patient, comprising: a first tube set having a tube of first length and a tube of second length, each having a proximal and distal end; a first connector member positioned at the proximal end of the tube of first length and configured to connect to a flushing syringe; a valve assembly positioned at the distal end of the tube of first length, comprising a proximal port, a distal port and a third port; a second connector member connecting the distal end of the tube of first length to the proximal port; a third connector member connected to the distal port; and a fourth connector member connecting a first swabable valve and a tube of second length to the third port; wherein a container for holding medical fluid is detachably connected to the first swabable valve, and the valve assembly selectively provides fluid connections between the proximal port, the distal port and the third port.

[0014] Section 2: The system according to Section 1, wherein a third connector member connected to a distal port is connected to the proximal end of a second tube set, and the second tube set further comprises a one-way check valve configured to allow fluid flow toward the distal end of the second tube set.

[0015] Section 3: The system described in Section 1 or 2, wherein the second tube set is an administration line connected to a catheter configured to be fluid-connected to a patient.

[0016] Paragraph 4: The system described in any one of paragraphs 1 to 3, wherein the administration line is a single-use set.

[0017] Item 5: The system according to any one of items 1 through 4, wherein the first tube set and valve assembly is a multi-use set suitable for use in two or more patients, maintaining sterility.

[0018] Section 6: The system according to any one of sections 1 to 5, wherein the first connector member is connected to a flushing syringe, the flushing syringe being a manual syringe, an automatic injector, or a syringe connected to a fluid injection system.

[0019] Section 7: The system according to any one of sections 1 to 6, wherein a flushing syringe contains flushing fluid, a valve assembly provides a fluid connection between the proximal port of a first tube set and the distal port of a second tube set, and the action of a plunger or piston of the flushing syringe pushes the flushing fluid through the second tube set to flush the administration line.

[0020] Clause 8: The system according to any one of Clauses 1 to 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.

[0021] Section 9: The system described in any one of sections 1 through 8, wherein the tubing of first length is sized to hold a maximum volume of approximately 30 mL of medical fluid.

[0022] Item 10: The system described in any one of items 1 through 9, wherein a tube of first length is sized to hold a volume of medical fluid ranging from 0.1 mL to approximately 15 mL.

[0023] Item 11: The system described in any one of items 1 through 10, wherein a tubing of first length is sized to hold a volume of medical fluid ranging from 0.1 mL to approximately 5 mL.

[0024] Section 12: The system according to any one of sections 1 to 11, wherein a tube of first length is made of a translucent polymer material so that the medical fluid in the tube of first length is visible to the user and / or sensors of the fluid injection system.

[0025] Claim 13: The system according to any one of claims 1 to 12, further comprising a mark configured to provide a volume-based measurement of the amount of medical fluid within the tube of the first length.

[0026] Claim 14: The system according to any one of claims 1 to 13, further comprising a volume control element positioned between a container containing medical fluid and the tube of the first length, the valve assembly providing a fluid connection between a third port and a proximal port, the volume control element selectively controlling the flow of fluid between the container and the tube of the first length such that a measured amount of medical fluid flows from the container into the tube of the first length.

[0027] Claim 15: The system according to any one of claims 1 to 14, wherein the container containing medical fluid is a second syringe, the valve assembly provides a fluid connection between a third port and a proximal port, and the second syringe selectively controls the flow of fluid between the second syringe and the tube of the first length such that a measured amount of medical fluid flows from the second syringe into the tube of the first length.

[0028] Claim 16: The system according to any one of claims 1 to 15, wherein a spike is connected to a swappable valve of the third port, and the container containing medical fluid is a pouch, bag, bottle or another reservoir configured to receive the spike, and when the container receives the spike, the container is fluidly connected to the valve assembly.

[0029] Claim 17: The system according to any one of claims 1 to 16, wherein the first connector member is connected to a flushing syringe connected to a fluid injection system, and the fluid injection system is programmed or controlled to operate a piston of the flushing syringe to draw a predetermined amount of medical fluid from the container into the tube of the first length.

[0030] Clause 18: The system according to any one of Clauses 1 to 17, wherein the second syringe comprises a pulse syringe, the pulse syringe being configured to selectively control the flow of fluid from the second syringe to a tube of first length by delivering a predetermined amount of medical fluid from the pulse syringe to a tube of first length a predetermined number of times.

[0031] Paragraph 19: The system according to any one of paragraphs 1 through 18, wherein a pulse syringe is connected to a fluid infusion system, the fluid infusion system being programmed or controlled to actuate a piston of the pulse syringe to deliver a predetermined amount of medical fluid from the pulse syringe to a tube of first length a predetermined number of times.

[0032] Item 20: The system according to any one of items 1 through 19, wherein the specified amount of medical fluid is in the range of 0.1 mL to approximately 1 mL.

[0033] Section 21: A system for use in delivering fluid to a patient, comprising: a tube of a first length having a proximal end and a distal end; a first syringe connected to the proximal end of the tube of the first length; and a valve assembly positioned at the distal end of the tube of the first length, comprising: a valve assembly having a first port, a second port and a third port, connector members connected to each of the first port, the second port and the third port, and a first swabable valve connected to the third port, wherein the second port is connected to the proximal end of a second tube set and to a catheter configured to be able to deliver fluid to a patient, the distal end of the tube of the first length is connected to the first port, and a container for containing medical fluid is detachably connected to the valve assembly, the system according to any one of sections 1 to 20.

[0034] Paragraph 22: The system according to any one of paragraphs 1 to 21, further comprising a second syringe and an additional connector member between a third port and the second syringe, wherein the second syringe is detachably connected to the additional connector member and the third port, and the connector member and the additional connector member are configured to selectively control the flow of fluid between a container, the second syringe and the first length of tube, so that a measured amount of medical fluid can flow from a container into a tube of first length or from the second syringe into a tube of first length.

[0035] Paragraph 23: The system according to any one of paragraphs 1 through 22, wherein the container is detached from a swabable valve and the swabable valve accepts a valve cap, or the second syringe is detached from an additional connector member and the additional connector member accepts a connector member cap.

[0036] Section 24: The system according to any one of sections 1 to 23, further comprising a third length tube having a proximal and distal end, the container comprising a pre-filled component positioned between a first length tube and a valve assembly, the proximal end of the third length tube connected to a first syringe, the distal end of the third length tube connected to a second tube set, the third length tube being a bypass line configured to deliver flushing fluid to the second tube set and the patient, the flushing fluid being delivered through the first length tube, and the pre-filled component being operated to deliver medical fluid through the first length tube to the second tube set and the patient.

[0037] Section 25: The system according to any one of sections 1 to 24, further comprising a syringe having a double-sided plunger, wherein a tube of first length.

[0038] Paragraph 26: The system according to any one of paragraphs 1 to 25, wherein a tube of first length further comprises a rolling diaphragm.

[0039] Clause 27: A system implemented in a fluid injection system, the fluid injection system comprising: a housing; at least one syringe; at least one drive member; at least one controller programmed or configured to actuate at least one drive member; a dosing line; a tube of a first length having a proximal end and a distal end; a first connector member positioned at the proximal end of the tube of the first length and configured to connect to at least one syringe of the fluid injection system; and a valve assembly positioned at the distal end of the tube of the first length, comprising a proximal port, a distal port and A system according to any one of claims 1 to 26, comprising: a valve assembly comprising: a third port; a second connector member for connecting the distal end of a tube of first length to a proximal port; a third connector member for connecting the distal port to the proximal end of an administration line; and a fourth connector member for connecting a first swabable valve to the third port, wherein the first swabable valve is detachably connected to the third port to a container for containing a medical fluid; the valve assembly selectively provides fluid connections between the proximal port, the distal port and the third port, the medical fluid being a liquid contrast medium; and at least one syringe being filled with a flushing fluid.

[0040] Paragraph 28: A fluid infusion system according to any one of paragraphs 1 to 27, wherein a valve assembly provides a fluid connection between a proximal port and a distal port, and the actuation of at least one drive member flushes the infusion line by pushing a flushing fluid from at least one syringe through the infusion line.

[0041] Paragraph 29: A fluid injection system according to any one of paragraphs 1 to 28, wherein a valve assembly further provides a fluid connection between a third port and a proximal port, thereby drawing a certain amount of liquid contrast medium into a tube of first length by the actuation of at least one drive member, or the container is a second syringe, and a certain amount of liquid contrast medium is pushed into a tube of first length by the actuation of a plunger of the second syringe.

[0042] Clause 30: The fluid infusion system according to any one of Clauses 1 to 29, wherein a valve assembly further provides a fluid connection between a proximal port and a distal port, thereby dispensing a certain amount of liquid contrast medium to a patient through an administration line from a tube of a first length by the actuation of at least one drive member.

[0043] Paragraph 31: The fluid injection system according to any one of paragraphs 1 to 30, further comprising a measuring sensor configured to measure the amount of liquid contrast medium being drawn into a tube of first length, the measuring sensor being configured to communicate with a controller when a predetermined amount of liquid contrast medium is drawn into or pushed into the tube of first length.

[0044] Paragraph 32: The fluid infusion system according to any one of paragraphs 1 to 31, further comprising an air sensor positioned on a second length tube and / or on a dosing line, the air sensor being configured to detect air in the second length tube and / or in the dosing line and to communicate the detection of air to a controller of the fluid infusion system.

[0045] Paragraph 33: A method of using a fluid infusion system as described in any one of paragraphs 1 to 32, the step of providing a fluid infusion system, the fluid infusion system comprising: a housing; at least one syringe; at least one drive member; at least one controller programmed or configured to actuate at least one drive member; a dosing line; a tube of a first length having a proximal end and a distal end; a first connector member positioned at the proximal end of the tube of the first length and configured to connect to at least one syringe of the fluid infusion system; a valve assembly positioned at the distal end of the tube of the first length, comprising a proximal port, a distal port, and a third port; a second connector member connecting the distal end of the tube of the first length to the proximal port; a third connector member connected to the distal port and configured to connect to the proximal end of the dosing line; and a fourth connector connecting a first swabable valve to the third port. A method comprising: a valve assembly comprising a connector member; priming at least one syringe by pushing flushing fluid into at least one syringe; connecting an administration line to a third connector member and the proximal port of the valve assembly; connecting the proximal end of a first length tube to at least one syringe of a fluid infusion system; priming the fluid infusion system by activating at least one drive member to push flushing fluid contained in at least one syringe through the first length tube and through the administration line; connecting a container for medical fluid to a first swabable valve; activating at least one drive member to draw a certain amount of medical fluid into the first length tube; and activating at least one drive member to push a certain dose of medical fluid from the first length tube to a patient through the administration line.

[0046] Further details and advantages of the various examples described in detail herein will become apparent when you examine the following detailed descriptions of the various examples in conjunction with the accompanying drawings.

[0047] Further advantages and details are described in more detail below with reference to the exemplary embodiments shown in the attached drawings. [Brief explanation of the drawing]

[0048] [Figure 1] This figure shows a non-limiting embodiment of an environment including a fluid injection system and a medical imaging system, according to one aspect of the present disclosure. [Figure 2] This figure shows a non-limiting embodiment of a fluid injection system according to one aspect of the present disclosure. [Figure 3] Figure 2 is a magnified view of the injector head unit of the fluid injection system shown. [Figure 4A] This figure shows an implementation of a non-limiting embodiment of a system for use with a fluid injection system, according to one aspect of the present disclosure. [Figure 4B] This figure shows the implementation of various components, including syringes, single-use tube sets, and multi-use sets, of a non-limiting embodiment of the system of Figure 4A according to one aspect of the present disclosure. [Figure 4C] This figure shows the implementation of various components, including syringes, single-use tube sets, and multi-use sets, of a non-limiting embodiment of the system of Figure 4A according to one aspect of the present disclosure. [Figure 4D] This figure shows the implementation of various components, including syringes, single-use tube sets, and multi-use sets, of a non-limiting embodiment of the system of Figure 4A according to one aspect of the present disclosure. [Figure 4E] Figures 4A to 4D show an implementation of a non-limiting embodiment of the system shown in operation, in which a flushing fluid is used to prime a syringe, a single-use tube set, and a multi-use set, according to one aspect of the method of the present disclosure. [Figure 4F] This figure shows an implementation of a non-limiting embodiment of the system shown in Figures 4A to 4E during a filling operation in which a certain amount of contrast medium is drawn into a set for multiple uses, according to one aspect of the method of the present disclosure. [Figure 4G] Figures 4A to 4F show an implementation of a non-limiting embodiment of the system shown in Figures 4A to 4F during an injection procedure in which a desired dose of contrast medium is flushed to a destination from a multi-use set, according to one aspect of the method of the present disclosure. [Figure 5] This diagram shows a non-limiting embodiment of a system for use with a fluid injection system and various components according to aspects of the present disclosure. [Figure 6] This diagram shows a non-limiting embodiment of a system for use with a fluid injection system and various components according to aspects of the present disclosure. [Figure 7] This diagram shows a non-limiting embodiment of a system for use with a fluid injection system and various components according to aspects of the present disclosure. [Figure 8A] This diagram shows a non-limiting embodiment of a system for use with a fluid injection system and various components according to aspects of the present disclosure. [Figure 8B] This diagram shows a non-limiting embodiment of a system for use with a fluid injection system and various components according to aspects of the present disclosure. [Figure 9A] This diagram shows a non-limiting embodiment of a system for use with a fluid injection system and various components according to aspects of the present disclosure. [Figure 9B] This diagram shows a non-limiting embodiment of a system for use with a fluid injection system and various components according to aspects of the present disclosure. [Figure 10] This diagram shows a non-limiting embodiment of a system for use with a fluid injection system and various components according to aspects of the present disclosure. [Figure 11] This diagram shows a non-limiting embodiment of a system for use with a fluid injection system and various components according to aspects of the present disclosure. [Figure 12] This diagram shows a non-limiting embodiment of a system for use with a fluid injection system and various components according to aspects of the present disclosure. [Figure 13] This is a sequence diagram of a non-limiting embodiment of a method for using a device, system, and / or fluid injection system according to aspects of the present disclosure. [Modes for carrying out the invention]

[0049] Corresponding reference numerals indicate corresponding parts through some of the figures. The examples described herein illustrate exemplary embodiments of the disclosure, and such embodiments should not be construed as limiting the scope of the disclosure in any way.

[0050] It should be understood that this disclosure may assume various alternative variations and sequences of steps unless expressly specified otherwise. It should also be understood that certain devices and processes shown in the accompanying drawings and described in the following specification are merely illustrative and non-limiting embodiments or aspects of this disclosure. Accordingly, certain dimensions and other physical characteristics relating to embodiments or aspects disclosed herein should not be considered limiting unless otherwise indicated.

[0051] For the purposes of the following description, the terms “end,” “top,” “bottom,” “right,” “left,” “vertical,” “horizontal,” “upper,” “bottom,” “lateral,” and “longitudinal,” and their derivatives, shall be relevant to embodiments or aspects of the present disclosure as they are oriented in the drawings. However, it should be understood that embodiments or aspects may envision various alternative variations and sequences of steps unless expressly otherwise specified. Spatial or directional terms such as “left,” “right,” “inside,” “outside,” “up,” and “down” should not be considered limiting, as the present disclosure may take various alternative directions.

[0052] All figures used herein and in the claims should be understood to be modified in all cases by the term “about.” The terms “approximately,” “about,” and “substantially” mean a range of ±10% of the stated value.

[0053] 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 two or more of A, B, and C. For example, “at least one of A, B, and C” includes one or more A alone, or one or more B alone, or one or more C alone, or one or more A and one or more B, or one or more A and one or more C, or one or more B and one or more C, or one or more of all 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 two or more of D, E, and F. For example, “at least two of D, E, and F” includes one or more Ds and one or more Es, or one or more Ds and one or more Fs, or one or more Es and one or more Fs, or one or more of all of D, E, and F.

[0054] The aspects, components, elements, structures, actions, steps, functions, instructions, etc., used herein should not be construed as definitive or essential unless expressly stated otherwise. Furthermore, where used herein, the articles “a” and “an” are intended to include one or more items and may be used interchangeably with “one or more” and “at least one.” Where used herein and in the claims, the singular “a,” “an,” and “the” include multiple referents unless otherwise explicitly indicated by the context. When only one item is intended, the term “one” or a similar term is used. Also, where used herein, terms such as “has,” “have,” and “having” are intended to be open-ended terms. Furthermore, the phrase “based on” is intended to mean “at least partially based on” unless otherwise specified.

[0055] When used in reference to components of a fluid infusion system, such as a fluid reservoir, syringe, or fluid line, the term “distal” refers to the part of the component closest to the patient. When used in reference to components of a fluid infusion system, such as a fluid reservoir, syringe, or fluid line, the term “proximal” refers to the part of the component closest to the injector of the fluid infusion system (i.e., the part of the component furthest from the patient). When used in reference to a syringe in a disposable set for multiple patients, the term “proximal” refers to the part of the syringe closest to the piston for delivering fluid from the syringe. When used in reference to components of a fluid infusion system, such as a fluid reservoir, syringe, or fluid line, the term “upstream” refers to the direction away from the patient towards the injector of the fluid infusion system. When used in reference to components of a fluid infusion system, such as a fluid reservoir, syringe, or fluid line, the term “downstream” refers to the direction away from the injector of the fluid infusion system towards the patient.

[0056] Embodiments of this disclosure are generally directed toward a system for use with a fluid infusion system, which may include a tube of a first length and a tube of a second length, a first connector member positioned at the proximal end of the tube of the first length configured to connect to a syringe, and a valve assembly positioned at the distal end of the tube of the first length. The valve assembly may include a proximal port, a distal port, and a third port, a second connector member connecting the tube of the first length to the proximal port, a third connector member connected to the distal port, and a fourth connector member connecting a first swabable valve to the third port. A container for medical fluid may be detachably connected to the first swabable valve. The valve assembly may 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 may be a T-port or Y-port extending perpendicularly to or at an angle to an axis defined between the proximal and distal ports, respectively.

[0057] In this way, embodiments of the present disclosure enable the measurement of precise volumes and / or small amounts, the retention of precise volumes and / or small amounts, and / or the delivery of precise volumes and / or small amounts of medical fluids, such as small amounts of contrast medium, for use in fluid infusion systems and for injection into patients.

[0058] As similar reference numerals point to similar parts in some of the figures, this disclosure is generally directed toward devices, systems, associated components, and methods for holding and / or measuring medical fluids and ultimately delivering medical fluids to patients. This disclosure is generally described in relation to the pressurized infusion of liquid radiographic contrast materials and / or diluents / flushing agents 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 devices, systems, and methods described herein may also be used in other applications where the intravenous injection of precise doses of fluids such as contrast media, diluents, therapeutics, pharmaceuticals, and drugs is indicated. Such procedures and / or treatments include, but are not limited to, nuclear medicine imaging, molecular imaging, radiopharmaceutical injections, and cardiovascular local therapeutic procedures.

[0059] Furthermore, while this disclosure can be applied to computed tomography (CT) and / or angiography type infusion systems, such as the MEDRAD® Stellant FLEX CT infusion system or the MEDRAD® Mark 7 arterial infusion system, respectively, this specification applies in the context of infusion systems designed for use in magnetic resonance (MR) imaging procedures. In particular, this disclosure is described in relation, for example, to the MEDRAD® MRXperion MR infusion system provided by Bayer HealthCare LLC. The MEDRAD® MRXperion MR infusion system is a dual-head (a / k / dual syringe) type system, but it will be apparent that this disclosure can be used in relation to a single-head (a / k / single syringe) type infusion system. In further embodiments, the infusion systems described herein may be used in relation to handheld syringe infusion protocols.

[0060] Referring first to Figure 1, a non-limiting embodiment of an MR medical imaging room 800 in which the devices, systems, and methods of this disclosure may be used is shown. The medical imaging room 800 may be located in a hospital and / or imaging center for performing imaging procedures on a patient for diagnostic purposes. The medical imaging room 800 may include a scanning room 814 in which a fluid infusion system 804 and a medical imaging system 806 are located, and a control room 816 in which an operator (e.g., a radiologist) can perform infusion and imaging procedures and monitor the patient via one or more workstation devices 802 associated with the fluid infusion system 804 and / or the medical imaging system 806. The fluid infusion system 804 may include a multi-fluid delivery system such as the MEDRAD® MRXperion MR infusion system described above. As shown in Figure 1, the workstation devices 802 may be used by the operator to set up and / or perform the fluid infusion procedures. In some non-limiting embodiments, the workstation device 802 may provide the display unit 808 with a user interface (e.g., an application-based user interface, a web-based user interface, etc.) for controlling the fluid injection system 804 and the medical imaging system 806. Parameters for the injection protocol of the fluid injection procedure may be entered by the user, retrieved 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, may be displayed on the workstation device 802 and / or communicated to the fluid injection system 804 for execution.

[0061] Referring here to Figure 2, a diagram of a non-limiting embodiment of the fluid injection system 804 shown in Figure 1, of a type in which devices, systems, and methods according to aspects or examples of the present disclosure may be used. Specifically, Figure 2 is an enlarged sub-view of the scanning chamber unit 805 of the MEDRAD® MRXperion MR injection system. While various embodiments of the present disclosure are described in relation to the use of the MEDRAD® MRXperion MR injection system, it should be understood that various systems and methods may be applied to other types and other brands of fluid injection systems, and that systems and methods are not limited to any particular fluid injection system. In some non-limiting embodiments, the scanning chamber unit 805 includes a pedestal 811 mounted on a base 813 with lockable casters 817 attached to the bottom for use when moving the scanning chamber unit 805 within the scanning chamber 814 as needed during imaging procedures. The pedestal 811 may also include an integrated IV pole 818 including one or more hooks 819 for suspending IV-related accessories. In some non-limiting embodiments, the base 813 houses various electronic and communication components, as well as power supplies for the scanning chamber unit 805. Among other connections, the scanning chamber unit 805 has a power cable 821 and an optical fiber link 822 that communicate with a workstation device 802 to enable control of the operation of the fluid injection system 804 from outside the scanning chamber 814, as shown in Figure 1.

[0062] Referring now to Figure 3, and then to Figure 2, an enlarged view of the injector head unit 850 of the fluid injection system 804 shown in Figure 2 is provided. Specifically, Figures 2 and 3 show non-limiting embodiments of the injector head 850 of the scanning chamber unit 805 of the fluid injection system 804. As these figures show, the injector head 850 may include a housing 851 and at least one fluid reservoir 860a / 860b, such as at least one syringe. The injection system 804 may include drive members for controlling the flow of fluid into and out of the fluid reservoirs / syringes, such as pistons associated with each syringe 860a / 860b that drive associated plungers in the barrels of the syringes. A controller or injection protocol management system may control the operation of the drive members. Each of the syringes 860a / 860b is adapted to be releasably connected to the housing 851 at a port 855 therefor, and is configured to be filled with a medical fluid F, such as imaging contrast medium, in syringe 860a, and a flushing fluid, such as saline solution, in syringe 860b.

[0063] In some non-limiting embodiments, the fluid injection system 804 may be used during a conventional imaging procedure and may inject contrast medium and / or saline into the patient's vascular system by selectively driving plungers associated with contrast agent syringe 860a and / or saline syringe 860b, or both, using their respective drive components. As shown in Figure 3, for each syringe 860a / 860b, the drive component may move the plunger toward the distal end 861 of the syringe to discharge the fluid within it from the syringe into and through the fluid pathway set 1000 during the priming step, the purging step, and / or the fluid delivery step. In some non-limiting embodiments, the fluid pathway set 1000 includes at least one tube or set of tubes configured to be in fluid communication with each syringe 860a / 860b, and the syringes may be positioned in fluid communication with the flexible administration tube and its associated catheter to deliver fluid to the patient from each syringe 860a / 860b or both syringes 860a / 860b at a desired vascular access site.

[0064] As shown in Figure 3, the injector head 850 may include various control buttons, control knobs, and control indicators for monitoring and influencing the operation of the fluid injection system 804.

[0065] Referring here to Figures 4A–4G, non-limiting embodiments of the system 200 for use with a fluid infusion system according to one aspect or example of the present disclosure are shown. As shown in Figures 4A–4G, the system 200 is applied, for illustrative purposes, to the fluid infusion system 804 shown in Figures 1–3, or to a handheld syringe-based infusion setup as illustrated. Figure 4A shows the system 200 for delivering precise and small amounts of medical fluid, such as contrast agent, to a patient in one non-limiting embodiment. In some non-limiting embodiments, the system 200 may include a combination of single-use (per-patient) tube sets 220 and multi-use (per-day) sets 230. In other embodiments, the entire system 200 may be configured as a single-use system that is discarded or recycled after the patient infusion protocol is completed. The system 200 may also include a syringe 300. Although the present disclosure requires the use of a syringe, such syringes are commercially available from various suppliers and therefore obviously do not need to be supplied as part of a kit containing the components of the present disclosure. As shown in Figures 4A to 4G, the syringe may be a handheld syringe, or in other embodiments, the syringe may be attached to a fluid infusion system as described herein. For example, the syringe may be attached to a single-head or dual-head fluid infusion system, such as a syringe filled with saline solution attached to an injector head 850.

[0066] Referring here to Figures 4B to 4D, various configurations of components, including a syringe 300, a single-use second tube set 220, and a multi-use first tube set 230, are shown for non-limiting embodiments of the system 200 of the present disclosure. Figure 4B shows an operator holding syringe 300, Figure 4C shows an operator holding single-use tube set 220, and Figure 4D shows an operator holding multi-use set 230. In certain non-limiting embodiments, syringe 300 may be a handheld syringe or may be configured to connect to an injector head 850 of the infusion system 804, and thus may be implemented as a saline syringe or flushing fluid syringe 860b that is detachably attached to the injector head 850 at a port 855 designated for that purpose. In other embodiments, the flushing fluid may be actuated and flowed by a peristaltic pump assembly. Preferably implemented as a low-pressure tubing set, the single-use tubing set 220 has, for example, a one-way check valve 222 at its distal end, intended for connection to a catheter inserted into the appropriate blood vessel of the patient. The check valve 222 can prevent backflow through the single-use components, as well as contamination of the upstream multi-use components by body fluids and / or microbial contaminants. At its proximal end, the single-use tubing set 220 is intended to connect to the distal end of a multi-use set 230. The multi-use set 230 at its proximal end is adapted to connect to a syringe 300, for example, as implemented as the saline syringe 860b in the infusion system 804 shown in Figures 2 and 3.

[0067] As shown in Figure 4D, the multi-use set 230 includes a first tube set 230 having a first-length tube 232, a pre-filled syringe 234, a three-port stopcock valve assembly 240, and a swabable valve 250, such as a commercially available swabable valve from Halkey-Roberts in St. Petersburg, Florida. Although shown in Figure 4D as a pre-filled syringe containing MR contrast medium, alternatively, the pre-filled syringe 234 may be implemented in a different form, such as a bag, pouch, or vial of MR contrast medium to which a spike on the valve assembly 240 can be connected. The first-length tube 232 may have an inner diameter that is larger than, equal to, or smaller than the inner diameter of the single-use tube set 220. At its proximal end, the tube section 232 is designed to connect to the nozzle 310 of syringe 300 / 860b via a Luer or other suitable connector 233. The three-port valve assembly 240 features a proximal port 242, a distal port 244, and a third port 246. The proximal port 242 connects to the distal end of a first-length tube 232 via a second connector member such as a Luer or other suitable connector, and the distal port 244 is designed to connect to the proximal end of a single-use tube set 220 via a second connector member such as a Luer or other suitable connector 224, as shown in Figure 4C. The third port 246 is designed to connect to a fourth connector member via a swabable valve 250 or other suitable dripless valve assembly, the other end of which is intended to connect to a medical fluid container such as the Luer tip of a pre-filled syringe 234. In this non-limiting embodiment, a pre-filled syringe 234 is filled with MR contrast medium. The syringe 234 may include markings on its outer surface, as described herein, indicating the amount of contrast medium to be contained therein, allowing the user to determine the amount of contrast medium to be injected into a tube of a first length.In certain embodiments, syringe 234 may be a handheld syringe and may include, for example, one or more stoppers or threads on the piston of syringe 234, allowing for precise dosing of small amounts of contrast medium from syringe 234 to a tube 232 of a first length by moving a desired number of stoppers or dialing the correct number of threads. Alternatively, syringe 234 may be a precision dosing syringe, such as a microdosing syringe, having a precise desired amount of contrast agent to be used in a single injection protocol, so as to have the exact amount of contrast agent injected from syringe 234 into a tube 232 of a first length.

[0068] The system 200 is suitable for connection to the fluid injection system 804 described herein and for operation with it according to the exemplary method. For example, with its proximal end connected to a suitable port 855 of the injector head 850, the syringe 300 / 860b may be connected by its nozzle 310 to a first-length tube 232 of a multi-use set 230 via a Luer or other suitable connector 233. At the other end of the multi-use set 230, the distal port 244 of the valve assembly 240 may be connected by a third connector member to the proximal end of a single-use tube set 220 via a Luer or other suitable connector 224. When assembled in this manner, the system 200 is ready for use with the fluid injection system 804 in injection procedures for contrast-enhanced imaging.

[0069] Before being connected to the multi-use tube set 230, the syringe 300 / 860b according to this embodiment of the method may be primed with saline solution from a bag, bottle, or other suitable container. With its nozzle 310 connected to the container, the syringe 300 / 860b may be filled with saline solution or other flushing fluid, and any air may be primed from the syringe either manually or automatically 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 tube 232 of the multi-use set 230 as described above. In the multi-use set 230 connected to the single-use tube set 220 described herein, the saline syringe 300 / 860b is ready to be used to prime both the first length tube 232 of the multi-use set 230 and the second single-use tube set 220, as shown in Figure 4E. During priming of the first length tube 232 and the second single-use tube set 220, the valve assembly 240 is configured to prevent fluid communication with the third port, so that saline does not flow into the pre-filled syringe 234 (or other suitable container 234). In various embodiments, it is not necessary to connect the pre-filled syringe 234 to the swabable valve 250 while the tube section 232 and the single-use tube set 220 are being primed with saline. In various embodiments, the one-way valve in the swabable valve 250 can prevent saline from entering the contrast agent syringe 234 and thus prevent dilution of the contrast medium contained therein.

[0070] Once priming is complete for syringe 300 / 860b, tube 232 of first length, and a second single-use tube set 220 containing saline solution, the system 200 may be filled with a small and precise amount of MR contrast medium according to this method. In particular, the tube section 232 of the multi-use tube set 230 may be primed with contrast agent. For this purpose, syringe 234 can be attached to a swabable valve 250, and the valve assembly 240 may be rotated to achieve fluid communication between the third port 246 and the proximal port 242 of the valve assembly. The fluid injection system 804 is controlled via its programming, its control buttons, or its manual knob 861b to retract the plunger of syringe 300 / 860b, thereby drawing a desired amount of MR contrast medium from a pre-filled syringe 234 (or other suitable container 234) through the swabable valve 250 and into a tube 232 of first length through both the third port 246 and the proximal port 242 of the valve assembly 240. As the MR contrast medium is drawn into the tube section 232, fluid communication with the distal port 244 is blocked by the valve assembly 240, preventing saline in the single-use tube set 220 from being drawn upstream, thereby maintaining the single-use tube set 220 in a saline-primed state. As shown in Figure 4F, the first length tube 232 is filled at its distal end with a desired amount of contrast agent, for example, 5 ml of MR contrast agent in one embodiment, while the remaining upstream portion of the first tube set and the entirety of the single-use tube set 220 are still primed with saline.

[0071] As described herein, once the system 200 is filled with both a flushing volume of saline and a desired volume of MR contrast agent, the system 200 is ready to be used according to an exemplary method having a fluid infusion system 804 to perform a desired infusion procedure. For example, in a particular embodiment, the valve assembly 240 may be configured to enable fluid communication between the proximal port 242 and the distal port 244, and the fluid infusion system 804 can be controlled via its programming, its control buttons, and / or its manual knob 861b to further extend a plunger into the barrel of the saline syringe 300 / 860b, thereby pressurizing the fluid in the fluid pathway defined by the syringe 300 / 860b, the tubing section 232, the valve assembly 240, the single-use tubing set 220, and the catheter to which the single-use tubing set 220 is connected. In this way, the desired amount of MR contrast agent is delivered from the tube section 232 through the valve assembly 240, the single-use tube set 220, and finally into the patient's body via the catheter to which the single-use tube set 220 is connected. This is shown in Figure 4G, which illustrates how the desired amount of contrast agent is delivered from the tube section 232 of the multi-use tube set 230 through the single-use tube set 220 into the patient's body via a catheter (not shown) inserted into a desired blood vessel (Figure 4G shows the distal end of the tube section 220 being discharged into a container during use, but note that the distal end of the tube section 220 is connected to a catheter fluidized to the patient's vascular system). According to a particular embodiment, the controller of the fluid injection system may be configured to actuate an actuator to control the valve assembly 240 to rotate an associated stopcock between various desired positions, depending on whether fluid communication between the third port 246 and the proximal port 242, or between the proximal port 242 and the distal port 244, or to prevent fluid communication between any of the three ports, for example, to stop the injection protocol.In other embodiments, one or more one-way check valves or high-crack pressure valves may be used to control the flow of contrast agent and saline through the proximal port 242, the distal port 244, and / or the third port 246 during the priming process and the injection process.

[0072] One intention of system 200 is to use a multi-use first-length tube 232 as a short-term volume-holding vessel for a small amount of contrast agent to be delivered to the patient. As described herein, the contrast agent may be provided in the form of a pre-filled syringe, bag, pouch, or vial, which may have a spike with a male Luer connector connected to the multi-use tube set 230 via a valve assembly 240. For example, a third port 246 of the valve assembly 240 prevents pressurized saline from syringe 300 / 860b from entering the pre-filled syringe (or bag, pouch, vial), and allows KVO (keep vein open) action and saline flushing by fluid communication between the proximal port 242 and the distal port 244. The proximal port 242 of the valve assembly 240 allows the contrast agent to be drawn into the tubing section 232 of the multi-use tubing set 230 and "filled in the line" as the plunger of the saline syringe 300 / 860b retracts. In certain embodiments, it is evident that the tubing section 232 may be implemented with a larger inner diameter (ID) and / or a larger length so as to be able to hold any amount of contrast agent from 1 ml to 30 ml or more. Alternatively, a smaller ID of the tubing section 232 may allow it to hold a smaller, more precise amount of contrast agent. Once the first length of tubing 232 is filled with the desired amount of contrast agent, the plunger of the syringe 300 / 860b can be advanced to flush the system with saline, pushing the contrast agent into the single-use tubing set 220 and finally into the patient's body via the catheter. This extension of the plunger into the barrel of syringe 300 / 860b also flushes the system and the patient's blood vessels with saline, allowing the contrast agent to be taken up by the patient's vascular system. Although this specification primarily describes the delivery of contrast agents, the System 200 is equally well suited for use in the delivery of medications to patients.

[0073] Embodiments of the system 200 having a multi-use set 230 and a swabable valve 250, whether used with a single-syringe or dual-syringe type infusion system, may be used with pre-filled syringes 234 or bags, pouches or vials of contrast agent or drug, into which spikes are inserted to deliver multiple doses of contrast medium for multi-infusion protocols. In various embodiments, the fluid infusion system 200 can be controlled from a scanning room, such as a scanning room 814 in an MR room. The infusion system 200 may also utilize a wireless remote device so that its operator can remotely control the infusion procedure with patient safety in mind. The system is also readily adaptable for use with both syringes of a dual-head infusion system. For example, in addition to the use of saline syringes as described above, the system may also use a contrast agent syringe of a dual-head infusion system to draw more than the desired amount of contrast agent (or drug) into the tubing section 232 of the multi-use set 230. In this regard, the selected contrast agent syringe may have a diameter smaller than that of the saline syringe. Finally, the system can also be readily adapted for use with a cassette-type infusion system instead of a syringe-based infusion system. In this regard, the system can be implemented as a cassette designed to be loaded into and operated by such a cassette-type infusion system. For example, one or more stopcocks can be used to enable continuous supply of saline to the primary syringe (i.e., for filling and refilling the same).

[0074] Referring here to Figures 5 to 12, schematic diagrams of various non-limiting embodiments of System 200 according to one aspect of the present disclosure are shown. The exemplary embodiments of System 200 in Figures 5 to 12 may be the same as or similar to System 200 shown in Figures 4A to 4G, where similar reference numerals refer to similar parts or components.

[0075] Referring to Figures 5, 6, 8A, and 8B, exemplary embodiments of System 200 for use with a fluid infusion system are shown, including a first tube set 230 which may further include a first length tube 232 and a second length tube 236. As stated above, the first tube set 230 may be a multi-use set 230 so that the set 230 maintains sterility and is suitable for multiple injection procedures for multiple patients without contaminating the multi-use components. The first length tube 232 may be sized to hold volumes of 30 mL or less of fluid. For a particular patient and / or use case, the first length tube 232 may be sized to hold a comprehensive range of fluid volumes of 0.1 mL and 15 mL. However, the appropriate size and volume-based constraints of the tubes ultimately depend on the use case in which System 200 is applied, such as the prescribed treatment and the needs of individual patients. Thus, the first length tube and / or tube set 230 may also be sized and configured to hold larger or smaller volumes of fluid. For example, the first length tube 232 may be sized to hold a comprehensive range of fluid volumes from 0.1 mL to 5 mL, or a fluid volume in the range of 0.1 mL to 0.5 mL, for imaging procedures on pediatric patients.

[0076] In some non-limiting embodiments, the first length tube 232 of the multi-use set 230 may be made of a translucent polymer material so that the fluid in the first length tube is visible to the user and / or sensors of the fluid injection system 804. This visibility primarily helps enable accurate measurement of the medical fluid F when it is drawn from the syringe 234 into the system 200 and / or held in the multi-use set 230. Furthermore, but not limited to, substantially any tubes of the system 200, including the multi-use set 230 and the single-use set 220, may be made of translucent or transparent material. By including translucent tubes, additional configurations and additional opportunities are provided for holding and / or measuring the medical fluid before injection. Furthermore, additional protective measures are provided by enabling the user and / or sensors of the fluid injection system to ensure that the system is properly functioning. To further assist the user or the fluid injection system in measuring the fluid, the first length tube 232 (or other suitable tubing portion of the system) may include markings, such as volume scales, configured to provide volume-based measurements of the fluid in the first tubing portion 232 or in any other tube of a given length. These markings may be read by the user or by one or more sensors communicating with the injection system's controller to initiate or stop a priming step or fluid delivery step according to how the system 200 is used based on the amount of medical fluid being drawn into the first length tube 232.

[0077] In some non-limiting embodiments, if system 200 is applied to a fluid injection system such as a fluid injection system 804, the fluid injection system may include at least one measuring sensor configured to measure the amount of fluid, such as a liquid contrast medium, being drawn into a tube 232 of a first length. The measuring sensor may be configured to communicate with a controller of the fluid injection system when a predetermined amount of liquid contrast medium is drawn into or pushed into the tube of the first length.

[0078] Figures 5, 6, 8A, and 8B further illustrate a first connector member 233 that can be positioned at the proximal end of a tube 232 of a first length. The first connector member 233 may be configured to connect to a syringe 300 which may be intended to be connected to a fluid injection system 804. Thus, in some non-limiting embodiments of the system 200, the first connector member 233 may connect to a syringe 300 / 860b which may be a manual syringe, an automatic injector, or a syringe of a fluid injection system.

[0079] Continuing with reference to Figures 5, 6, 8A, and 8B, a first-length tube 232 and a second-length tube 236 may include a valve assembly 240 positioned between them, the valve assembly 240 being positioned at the distal end of the first-length tube 232. The valve assembly 240 may include a proximal port 242, a distal port 244, and a third port 246. As shown in the exemplary 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 tube 232 to the proximal port 242. As further shown, a third connector member 224b may be connected to the distal port 244, and a fourth connector member 224c connects the first swabable valve 250 and the second-length tube 236 to the third port 246. As described above, the third port 246 is designed to connect to the swabable valve 250, and the connection may be made by the third connector member 224b. In some non-limiting embodiments, as described 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 may include a one-way check valve and / or a Luer connector, or a combination thereof. In some non-limiting embodiments, the connector member may be housed within a valve including the connector member associated with the valve assembly 240, or may be part of the valve.

[0080] According to an exemplary embodiment, a container 234 containing a medical fluid F, such as a contrast medium, may be detachably connected to a first swabable valve 250. Once the relevant components of the system 200 are assembled, the valve assembly 240 may selectively provide fluid connections between the proximal port 242, the distal port 244, and the third port 246, and the system 200 may be used to perform priming, purging, and / or fluid measurement and delivery. In various embodiments, the valve assembly 240 may be manually actuated in response to one or more signals transmitted from a controller of the fluid infusion system, or it may be actuated by an actuator. For example, in a non-limiting embodiment provided with a syringe 300 / 860b containing a flushing agent such as saline, the valve assembly 240 provides a fluid connection between the proximal port 242 and the distal port 244. The actuation of the plunger 320 by the fluid infusion system then pushes the diluent through the second tube set 220, flushing the administration line 220. In certain embodiments, the plunger 320 may be operated manually, in which case the syringe 300 / 860b is a manual syringe.

[0081] Referring to Figures 8A and 8B, a non-limiting embodiment of system 200 is associated with a fluid injection system such as a fluid injection system 804, where the connector member 233 is connected to a syringe 300 / 860b of the fluid injection system, and the operation of the fluid injection procedure may be piston-driven. In such an embodiment, the fluid injection system 804 may be programmed or controlled to retract a plunger 320 to draw a predetermined amount of fluid from a container 234 into a tube 232 of a first length by acting on a piston associated with a valve assembly 240 and / or syringe 300 / 860b. In other embodiments, syringe 234 may be a manual syringe that allows a desired amount of contrast fluid to be manually added to the tube 232 of the first length. For example, syringe 234 may include one or more stoppers associated with a predetermined amount of fluid, e.g., 0.1 mL or 0.5 mL, and the user may move the piston of syringe 234 as many times as there are stoppers associated with the desired amount of contrast agent for the procedure. In other embodiments, the syringe or container 234 may include a dial, such as a threaded plunger, in which case the distance of rotation of the dial is related to the amount of contrast agent, and the user can rotate or move the dial a number of times related to the desired amount of contrast agent for the procedure. Other methods for precisely dispensing the desired amount of contrast agent from the container 234 are also conceivable.

[0082] In some embodiments, as shown in Figures 5 and 6, a third connector member 224b of the system 200 may connect the proximal end of the second tube set 220 to the distal port 244 of the valve assembly 240. In some non-limiting embodiments, the second tube set 220 may be an administration line or a single-use set 220, as discussed herein. The tube set 220 may also include a one-way check valve 222 located, for example, at the distal end of the tube set 220, allowing fluid to flow from there in a single direction, i.e., fluid flow directed toward the patient, while proximal fluid flow is blocked to prevent contamination of the multiple patient portions of the system. The distal end of the tube set 220 may be further connected to a catheter, such as a catheter 260, or another suitable connector to a patient line, for delivering medical fluid F to the patient.

[0083] In some non-limiting embodiments, such as those shown in Figures 5, 6, and 8A, the container 234 for containing the medical fluid F may be a second syringe 234. In such exemplary embodiments, a valve assembly 240 may provide a fluid connection between a third port 246 and a proximal port 242. The second syringe 234 may then selectively control the fluid flow between the second syringe 234 and a tube 232 of first length so that a measured amount of fluid can flow from the second syringe 234 into a tube of first length. Similar to syringes 300 / 860b, the second syringe 234 may be a manual syringe, or, in embodiments where system 200 relates to a fluid injection system, the second syringe 234 may be a syringe connected to and actuated by the fluid injection system.

[0084] In some non-limiting embodiments, as shown in Figures 5 and 6, the system 200 may include additional syringes, such as a third syringe, such as a microsyringe 600. To accommodate the microsyringe 600, an additional connector member 224d may be provided between the third port 246 and the syringe 234. As shown in Figure 5, the microsyringe 600 may be detachably connected to the additional connector member 224d and the third port 246. In such embodiments, during a priming or infusion procedure, a medical fluid may be drawn from the container 234 by the syringe 300 / 650b. For example, if a precise small amount of medical fluid is to be drawn from the syringe 234, the microsyringe 600 may be used to precisely measure the desired amount from the syringe 234 and then inject the desired amount into a tube 232 of a first length via the valve assembly 240. If the use of the microsyringe 600 is not desired or is not instructed for a particular procedure, the microsyringe 600 may be removed from the additional connector member 224d, which may accept the cap C.

[0085] As shown in Figure 5, in embodiments where the container 234 is implemented as a syringe, the medical fluid may be pushed out of the container 234. Alternatively, the container 234 may be detached from the system 200, and the swabable valve 250 may accept a cap to maintain the pressure of the system 200. In such embodiments, the microsyringe 600 may provide medical fluid for priming and / or infusion procedures so that a measured amount of medical fluid can flow from the microsyringe 600 into a tube 232 of a first length. As shown in Figure 6, where both the microsyringe 600 and the container 234 are provided, connector members 224a / 224b / 224c and additional connector member 224d are configured to selectively control the fluid flow between the container 234, the microsyringe 600, and the tube 232 of a first length. This allows a measured amount of medical fluid to flow from the container 234 into the tube 232 of a first length.

[0086] Referring here to Figure 7, an exemplary embodiment is shown in which the second syringe 234 is a pulse syringe 700. The pulse syringe 700 may include a dispenser piston 702 within the barrel of the pulse syringe 700 for dispensing a controlled, precise low dose of medical fluid. The dispenser piston 702 may be positioned at the distal end of the plunger assembly 704 of the pulse syringe. The dispenser piston 702 may also be enclosed by a cover 706 of the plunger assembly 704. The cover 706 may be made of rubber or another suitable elastomer. The pulse syringe 700 may further include a solenoid 708 whose actuation can drive an engaging piston 710. This engages the engaging piston 710 with the rubber cover 706 of the plunger assembly, thereby dispensing a controlled dose of medical fluid.

[0087] Accordingly, the pulse syringe 700 is configured to selectively control the flow of fluid from the second syringe 234 through the valve assembly 240 to the first length tube 232 by delivering a predetermined amount of medical fluid a predetermined number of times. Exemplary, non-limiting embodiments of the pulse syringe 700 may be associated with the fluid infusion system 804 described herein. The fluid infusion system 804 may be programmed or controlled to actuate a solenoid 708, thereby actinguating a dispensing piston 702 to deliver a predetermined amount of medical fluid a predetermined number of times (pulses). In some non-limiting embodiments, the predetermined amount of medical fluid may be as little as 0.1 mL per pulse or 1 mL per pulse. The predetermined amount can be any amount necessary for the system 200 to have a volume-based capacity. The predetermined number of pulses can similarly be any number of pulses necessary for the system 200 to have a capacity. For example, to achieve a volume of medical fluid of 5 mL held in the system 200, the pulse syringe may be pulsed 5 times, dispensing 1 mL per pulse.

[0088] In some non-limiting embodiments, as shown in Figure 8B, the system 200 may further include a dial 790 positioned between a container 234 and a first-length tube 232. While the valve assembly 240 provides a fluid connection between a third port 246 and a proximal port 242, the dial 790 may selectively control the fluid flow between the container 234 and the first-length tube 232, allowing a precisely measured amount of medical fluid to flow from the container into the first-length tube. The dial 790 may be configured to allow only a predetermined amount of fluid to be drawn from the container 234 with each rotation of the dial, or with each "click" (indicated by partial rotations or increments of linear motion, e.g., by audible or tactile clicks).

[0089] Referring further to Figure 8B, the container 234 for containing the medical fluid may be a pouch, bag, bottle, or another tank, and may be configured to receive a spike. The system 200 may include a spike 720 connected to a swabable valve 250 of a third port 246. The container 234 shown in Figure 8B as a fluid bag receives the spike 720 and is fluid-connected to a valve assembly 240. In such exemplary embodiments, the fluid may be drawn from the container 234 by a syringe 300 / 650b or by another means described herein. For example, as shown in Figure 6, the system 200 may include a microsyringe 600 connected to an additional connector member 224d. In the embodiment shown in Figure 8B, the medical fluid may be drawn from the container 234 using a dial 790. In other embodiments, another syringe or device may be provided for drawing in or pushing out the medical fluid from the container 234.

[0090] Referring here to Figures 9A–11, a non-limiting embodiment of system 200 is shown, which includes a saline bypass line, indicated as a third-length tube 238. In exemplary embodiments, syringe 860 may be a dual syringe system, such as that of fluid infusion system 804. In such embodiments, the container for the medical fluid may be a pre-filled component 900 positioned between the first-length tube and valve assembly 240. As shown in Figure 9A, the proximal end of the third-length tube 238 is connected to syringe 860b, and the distal end of the third-length tube is connected to a second tube set 220 in valve assembly 240. In these exemplary embodiments, the bypass line 238 and the first-length tube 232 are in parallel and both can ultimately deliver fluid to the patient through an administration line, such as the second tube set 220.

[0091] The bypass line 238 is configured to deliver flushing fluid to the second tubing set 220 and the patient. Activating the piston / plunger 320 of the syringe 300 / 860b delivers the diluent through a first-length tube, activating a pre-filled component 900. The activation of the pre-filled component 900 pushes the medical fluid through the first-length tube to the second tubing set 220 and ultimately to the patient. The implementation of the saline bypass line, such as the bypass line 238 in system 200, offers the advantage of avoiding fluid communication between multiple medical fluids, such as diluents, and the drug. For example, avoiding fluid communication between saline and contrast medium prevents undesirable dilution of the contrast medium, which may also allow for smaller amounts of contrast medium.

[0092] Referring to Figure 10, the system 200 may also include a three-port valve positioned between a connector member 233 and the distal ends of each bypass line 238 and the first-length tube 232 to control the flow of fluid from the syringe 300 / 860b to the bypass line 238 and / or the first-length tube 232. As shown in Figure 10, the three-port valve may also be a stopcock 952, which may be associated with a fluid injection system 804. The fluid injection system 804 may be configured to actuate the stopcock to complete the fluid connection between the syringe 300 / 860b and the first-length tube 232 and the pre-filled component (i.e., the double-sided plunger 950 in Figure 10), or between the syringe 300 / 860b and the bypass line 238. The stopcock associated with the fluid injection system 804 may also be implemented in place of other valves / valve assemblies in the present disclosure so that the system 200 can be at least partially or fully automated.

[0093] In some non-limiting embodiments, the container 234 for containing the medical fluid may be any suitable pre-filled component, such as a syringe having a double-sided plunger 950 as shown in Figure 10, a rolling diaphragm 960 as shown in Figure 11, or a cassette 970 as shown in Figure 12. The pre-filled component may be manufactured with a precise dose of the medical fluid, such as a contrast agent, or may be filled by the user before being implemented in the system 200. For embodiments of the system 200 applied to the fluid injection system 804, the use of pre-filled components such as the double-sided plunger 950, the rolling diaphragm 960, and the cassette 970 is ideal. In some embodiments, the pre-filled component may include computer-readable media such as barcodes, QR codes®, RFID tags, text, symbols, and the fluid injection system may include a scanner or other sensor capable of reading barcodes and transmitting data about the pre-filled component to a controller or injection protocol management system associated with the fluid injection system 804. The controller may use the data in combination with other input data to perform appropriate priming / injection procedures. The pre-filled component configurations shown in Figures 9A to 12 allow for the use of smaller amounts of tubing when supplying larger volumes of medical fluid. By using pre-filled components instead of extended tubing, the linear space occupied within the system 200 can be reduced.

[0094] Referring here to Figure 12, a non-limiting embodiment of the system 200 including pre-filled components is shown, where the pre-filled components are implemented as a cassette 970 containing a pre-filled bottle or syringe 972. In this exemplary embodiment, the system 200 may be the same as or similar to the embodiments illustrated in Figures 5 and 6, and may further include an air sensor 730. The air sensor 730 may be positioned on a second length tube 236 and / or on the administration line 220. The air sensor may be configured to detect air in the system 200 and may communicate the detection of air to a controller of the fluid infusion system. When air is detected in the system 200, the fluid infusion system may be controlled to initiate a flushing procedure or to stop a priming or infusion procedure.

[0095] Referring here to Figure 13, a sequence diagram of method 1300 for using system 200 applied to fluid injection system 804 is shown. In some non-limiting embodiments, step 1302 of method for using fluid injection system may include the step of providing a suitable fluid injection system and various desired components of system 200, such as those described in detail above.

[0096] For illustrative purposes, a fluid infusion system may include a housing, at least one syringe, at least one drive member, at least one controller programmed or configured to control the operation of at least one drive member, and a dosing line, according to any of the various embodiments of the system described herein. The fluid infusion system may further include a tube of a first length having a proximal end and a distal end, and a first connector member positioned at the proximal end of the tube of the first length. The first connector member may be configured to connect to at least one syringe of the fluid infusion system, and a valve assembly may be positioned at the distal end of the tube of the first length. The valve assembly may include a proximal port, a distal port, and a third port. A second connector member may connect the distal end of the tube of the first length to the proximal port. A third connector member may connect to the distal port and may be configured to connect to the proximal end of a dosing line. A fourth connector member may connect a first swabable valve to the third port.

[0097] The fluid injection system may be provided in any suitable environment for performing the desired injection procedure or injection treatment. For example, if the desired procedure is the injection of contrast medium before an imaging procedure, the fluid injection system may be provided in the medical imaging room 800 described above.

[0098] In step 1304 of the method shown in Figure 13, the method may further include the step of priming at least one syringe by pushing a diluent through at least one syringe. In step 1306 of the method, the method may include the step of connecting the administration line to the proximal port of the third connector member and valve assembly. In step 1308 of the method, the method may further include the step of connecting the proximal end of a first-length tube to at least one syringe of the fluid infusion system. In this state, after the connections in steps 1306 and 1308 are completed, the fluid infusion system may be ready to perform the saline priming procedure. Thus, in step 1310 of the method, the method may include the step of priming the fluid infusion system by activating at least one drive member to pass a flushing fluid, such as saline, from at least one syringe through a first-length tube and through the administration line.

[0099] As shown in step 1312 of the method in Figure 13, the method may include the step of connecting a container containing a medical fluid, such as an MR contrast medium, to a first swabable valve. However, it should be understood that the connection of the container, which may be a syringe, bag, bottle, cassette, or any other suitable container, may also be performed before the saline priming procedure of step 1310, depending on the container being implemented and the desired infusion procedure. Once the fluid infusion system is primed and the desired medical fluid has been introduced into the system, at least one drive member may be activated to draw the desired dose or amount of medical fluid into a tube of first length, as shown in step 1314 of the method.

[0100] In some non-limiting embodiments, such as those shown in step 1316 of the method, the contrast medium or other medical fluid may be measured by the various means described above as the fluid enters the first length tube. Additionally or alternatively, in step 1318 of the method, the medical fluid may be held in the system until the infusion procedure is performed. In some non-limiting embodiments, the fluid may be measured while it is held by the system. In step 1320 of the method, when infusion is desired, at least one drive member may be activated to push a dose of medical fluid through the administration line from the first length tube to the patient.

[0101] Examples of various use cases for this system include, for example, its application 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.

[0102] Several examples of devices, systems, related components, and methods for measuring and / or maintaining precise doses of medical fluids for use in fluid injection systems are shown in the accompanying figures and described in detail above, but other embodiments will be apparent and easily made to those skilled in the art without departing from the scope and spirit of this disclosure. Therefore, the foregoing description is intended to be illustrative rather than restrictive. The various embodiments of this disclosure described above are defined by the accompanying claims, and all modifications to the disclosed concepts that fall within the same meaning and scope as the claims should be included within those scopes.

[0103] The systems, methods, and various embodiments and aspects thereof described above are described in detail for illustrative purposes based on what is currently considered to be the most practical and preferred embodiments; however, such details are for that purpose only, and it should be understood that this disclosure is not limited to the embodiments or aspects described, but rather intended to cover modifications and equivalent configurations that fall within the spirit and scope of the system. For example, it should be understood that this disclosure intends, wherever possible, to allow one or more features of any embodiment or aspect to be combined with one or more features of any other embodiment or aspect. In fact, any of these features can be combined in ways not specifically disclosed herein. [Explanation of Symbols]

[0104] System for use with 200 fluid injection systems 220 Single-Use Tube Set 222 One-way check valve 224 Lure or other suitable connector 224a Second connector member 224b Third connector member 224c Fourth connector member 224d Additional connector component 230 Reusable Tube Set 232 Tube of the first length 233 First connector member 234 Pre-filled syringe or other suitable container 236 Second length tube 238 Third length tube 240 3-port stopcock valve assembly 242 proximal ports 244 Distal Port 246 Third Port 250 Swabable Valves 260 catheters 300 syringes 310 nozzles 320 plungers 600 microsyringes 700 pulse syringes 702 Dispenser Piston 704 Plunger Assembly 706 Cover 708 Solenoid 710 Engaging piston 720 Spikes 730 Air Sensor 790 Dial 800 MR Medical Imaging Room 802 Workstation Devices 804 Fluid Injection System 805 Scanning Room Unit 806 Medical Imaging System 808 Display Unit 811 Pedestal 813 Base 814 Scanning Room 816 Control Room 817 Caster 818 Integrated IV Pole 819 Hook 821 Power Cable 822 Fiber Optic Link 850 Injector Head Unit 851 Housing Port 855 860a, 860b Fluid Reservoir / Syringe 861 Distal end of syringe 861a, 861b Manual knob 900 Pre-filled components 950 Double-sided plunger 952 Stopcock 960 Rolling Diaphragm 970 Cassette 972 Pre-filled bottles or syringes 1000 Fluid Path Sets

Claims

1. A system for use in delivering fluids to patients, A first tube set having a tube of a first length and a tube of a second length, wherein the first tube and the second tube each have a proximal end and a distal end, A first connector member positioned at the proximal end of the tube of the first length, configured to connect to a flushing syringe, A valve assembly positioned at the distal end of the tube of the first length, The proximal port, the distal port, and the third port, A second connector member connects the distal end of the first length tube to the proximal port, A third connector member connected to the distal port, A valve assembly comprising a first swabable valve and a fourth connector member connecting the second length tube to the third port, Equipped with, A container for medical fluid is detachably connected to the first swabable valve. A system in which the valve assembly selectively provides fluid connections between the proximal port, the distal port, and the third port.

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

3. The system according to claim 2, wherein the second tube set is an administration line connected to a catheter configured to be fluid-connectable to a patient.

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

5. The system according to any one of claims 1 to 4, wherein the first tube set and the valve assembly are a set for multiple uses, suitable for use in two or more patients, while maintaining sterility.

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

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

8. The system according to any one of claims 1 to 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.

9. The system according to any one of claims 1 to 8, wherein the tube of the first length is sized to hold a maximum volume of approximately 30 mL of the medical fluid.

10. The system according to claim 9, wherein the first length tube is sized to hold an amount of the medical fluid in the range of 0.1 mL to about 15 mL.

11. The system according to claim 9, wherein the first length tube is sized to hold an amount of the medical fluid in the range of 0.1 mL to about 5 mL.

12. The system according to any one of claims 1 to 11, wherein the tube of the first length is made of a translucent polymer material so that the medical fluid in the tube of the first length is visible to the user and / or sensors of the fluid injection system.

13. The system according to any one of claims 1 to 12, wherein the tube of the first length further comprises a mark configured to provide a volume-based measurement of the amount of medical fluid in the tube of the first length.

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

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

16. The spike is connected to the first swabable valve of the third port, The container for containing the medical fluid is a pouch, bag, bottle, or other tank configured to receive the spike. The system according to any one of claims 1 to 13, wherein when the container receives the spike, the container is fluidly connected to the valve assembly.

17. The system according to any one of claims 1 to 16, wherein the first connector member is connected to the flushing syringe connected to a fluid injection system, and the fluid injection system is programmed or controlled to actuate a piston of the flushing syringe to draw a predetermined amount of the medical fluid from the container into a tube of a first length.

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

19. The system according to claim 18, wherein the pulse syringe is connected to the fluid injection system, and the fluid injection system is programmed or controlled to actuate the piston of the pulse syringe to deliver a predetermined amount of the medical fluid from the pulse syringe to a tube of a first length a predetermined number of times.

20. The system according to claim 18 or 19, wherein the predetermined amount of the medical fluid is in the range of 0.1 mL to about 1 mL.

21. A system for use in delivering fluids to patients, A tube of a first length having a proximal end and a distal end, A first syringe connected to the proximal end of the tube of the first length, A valve assembly positioned at the distal end of the tube of the first length, The first port, the second port, and the third port, A connector member connected to each of the first port, the second port, and the third port, A valve assembly comprising a first swabable valve connected to the third port, Equipped with, The second port is connected to the proximal end of the second tube set and to a catheter configured to allow fluid connection to the patient. The distal end of the tube of the first length is connected to the first port, A system in which a container for medical fluid is detachably connected to the valve assembly.

22. The aforementioned system, The second syringe, An additional connector member between the third port and the second syringe, Furthermore, The second syringe is detachably connected to the additional connector member and the third port. The system according to claim 21, wherein the connector member and the additional connector member are configured to selectively control the flow of fluid between the container, the second syringe and the first length tube so that a measured amount of the medical fluid can flow from the container into the first length tube or from the second syringe into the first length tube.

23. The system according to claim 22, wherein the container is detached from the first swabable valve and the first swabable valve accepts a valve cap, or the second syringe is detached from the additional connector member and the additional connector member accepts a connector member cap.

24. The system further comprises a third length tube having a proximal end and a distal end, and the container comprises a pre-filled component positioned between the first length tube and the valve assembly. The proximal end of the third length tube is connected to the first syringe, and the distal end of the third length tube is connected to the second tube set. The third length tube is a bypass line configured to deliver flushing fluid to the second tube set and the patient. The system according to any one of claims 21 to 23, wherein the flushing fluid is delivered through the first length tube, and the pre-filled components are operated to deliver the medical fluid through the first length tube to the second tube set and the patient.

25. The system according to claim 21, wherein the tube of the first length further comprises a syringe having a double-sided plunger.

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

27. A fluid injection system, 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, The administration line, A tube of a first length having a proximal end and a distal end, A first connector member positioned at the proximal end of the tube of the first length, configured to connect to at least one syringe of the fluid injection system, A valve assembly positioned at the distal end of the tube of the first length, The proximal port, the distal port, and the third port, A second connector member connects the distal end of the first length tube to the proximal port, A third connector member connects the distal port to the proximal end of the administration line, A valve assembly comprising: a first swabable valve and a fourth connector member for connecting the third port; Equipped with, The first swabable valve is detachably connected to the third port to a container for medical fluid. The valve assembly selectively provides fluid connections between the proximal port, the distal port, and the third port. A fluid injection system in which the medical fluid is a liquid contrast medium, and at least one syringe is filled with a flushing fluid.

28. The fluid infusion system according to claim 27, wherein the valve assembly provides a fluid connection between the proximal port and the distal port, and the actuation of the at least one drive member pushes the flushing fluid out of the at least one syringe through the dosing line to flush the dosing line.

29. The valve assembly further provides a fluid connection between the third port and the proximal port, thereby drawing a certain amount of the liquid contrast medium into the first length tube by the operation of the at least one drive member, or The fluid injection system according to claim 27 or 28, wherein the container is a second syringe, and a certain amount of the liquid contrast medium is pushed into the first length tube by the action of the plunger of the second syringe.

30. The fluid infusion system according to any one of claims 27 to 29, wherein the valve assembly further provides a fluid connection between the proximal port and the distal port, thereby dispensing a certain dose of the liquid contrast medium to the patient through the administration line from the first length tube by the actuation of the at least one drive member.

31. The fluid injection system further comprises a measuring sensor configured to measure the amount of liquid contrast medium drawn into the tube of the first length, The fluid injection system according to claim 29, wherein the measuring sensor is configured to communicate with the controller when a predetermined amount of liquid contrast medium is drawn into or pushed into the tube of the first length.

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

33. A method using a fluid injection system, A step of providing a fluid injection system, wherein the fluid injection system is 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, The administration line, A tube of a first length having a proximal end and a distal end, A first connector member positioned at the proximal end of the tube of the first length, configured to connect to the at least one syringe, A valve assembly positioned at the distal end of the tube of the first length, The proximal port, the distal port, and the third port, A second connector member connects the distal end of the first length tube to the proximal port, A third connector member is configured to be connected to the distal port and to be connected to the proximal end of the administration line, A valve assembly comprising: a first swabable valve and a fourth connector member for connecting the third port; It has steps, The steps include: priming the at least one syringe by pushing a flushing fluid into the at least one syringe; The steps include connecting the administration line to the third connector member and the proximal port of the valve assembly, The steps include connecting the proximal end of the tube of the first length to the at least one syringe of the fluid injection system, The steps include: activating the at least one drive member to prime the fluid injection system by pushing the flushing fluid contained in the at least one syringe through the first length tube and through the administration line; The steps include connecting a container for medical fluid to the first swabable valve, The steps include: activating at least one of the drive members to draw a certain amount of the medical fluid into the tube of the first length; The steps include: activating at least one of the drive members to push a certain amount of medical fluid from the first length tube through the administration line to the patient; Methods that include...

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